OHIO Part B Medicare Bulletin

Transcription

J15
JULY 2013
HOT TOPIC
INSIDE THIS ISSUE
Amount in Controversy (AIC) Requirement for Administrative
Law Judge Hearings and Federal District Court Appeals
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
1st Quarter Update Part B Not Otherwise Classified Drug Fee Schedule 2013
Payment Allowance Limits for Medicare Part B Not Otherwise Classified (NOC)
Drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
MM8269 - Ambulance Payment Reduc tion for NonEmergency Basic Life Support (BLS) Transports to and
from Renal Dialysis Facilities . . . . . . . . . . . . . . . . . . . 68
2nd Quarter Update Part B Not Otherwise Classified Drug Fee Schedule 2013
Drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
INSERT TOPICS: General Part B
4th Quarter Update Part B Not Otherwise Classified Drug Fee Schedule 2012
Drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Amount in Controversy (AIC) Requirement for Administrative
Law Judge Hearings and Federal District Court Appeals
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Balloon Sinusplasty (Local Coverage Article A51633): Retired
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
D ate s o f S e r v i c e : I s I t I C D - 9 o r I C D - 1 0 ? . . . . . . . . . . . . . . 2 7
D raf t LCD Applic ations of Bioengineered S kin S ubstitutes:
Ulcers (of Lower Ex tremities) DL33173 . . . . . . . . . . . . . . . . 28
Fe c a l M i c ro b i o t a Tr a n s f e r . . . . . . . . . . . . . . . . . . . . . . 4 3
REACHING OUT TO THE MEDICARE COMMUNITY
WWW.CGSMEDICARE.COM
Local Carrier Payment Allowance Limits for Medicare Part
B Drugs Effective April 1, 2013 through June 30, 2013
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
B Drugs Effective January 1, 2013 through March 31, 2013
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
B Drugs Effective July 1, 2012 through September 30, 2012
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Local Carrier Payment Allowance Limits for Medicare Par t B
Drugs Effective October 1, 2012 through December 31, 2012
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Loc al Coverage D etermination (LCD): Applic ation of Cellular and/or
Tissue Based Products (CTPs) for Wounds of Lower Extremities (L33173)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Bold, italicized material is excerpted from the American Medical Association Current
Procedural Terminology CPT codes. Descriptions and other data only are copyrighted
2009 American Medical Association. All rights reserved. Applicable FARS/DFARS apply.
MM8165 - Common Working File (CWF) Informational Unsolicited Response
(IUR) or Reject for a New Patient Visit Billed by the Same Physician or
P h y s i c i a n G r o u p w i t h i n t h e Pa s t T h r e e Ye a r s . . . . . . . . . . 5 8
J15
JULY 2013
A service of CGS
Kentucky General Release
MM8213 - Autologous Platelet-Rich Plasma (PRP) for Chronic Non-Healing Wounds
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
MM8219 - Use of a Rubber Stamp for Signature . . . . . . . . . . . . . . . . . 63
MM8223 - Phase III Electronic Remittance Advice (ERA) Enrollment Operating Rules
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
MM8255 - National Coverage Determination (NCD) for Transcatheter Aortic Valve
Replacement (TAVR) - Implementation of Mandatory Reporting of Clinical Trial
Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
MM8269 - Ambulance Payment Reduc tion for Non-Emergenc y Basic
L i f e S u p p o r t ( B L S ) Tr a n s p o r t s t o a n d f r o m R e n a l D i a l y s i s Fa c i l i t i e s
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
MM8286 - Quarterly Healthcare Common Procedure Coding
System (HCPCS) Drug/Biological Code Changes - July 2013 Update
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
M M 8 2 9 1 - J u l y U p d a t e t o t h e C a l e n d a r Ye a r ( C Y ) 2 0 1 3 M e d i c a r e
P h y s i c i a n Fe e S c h e d u l e D a t a b a s e ( M P F S D B ) . . . . . . . . . . . . . 7 0
REACHING OUT TO THE MEDICARE COMMUNITY
WWW.CGSMEDICARE.COM
MM8320 - Claim Status Categor y and Claim Status Codes Update . . . . . . 74
M M 8 3 2 5 - J u l y Q u a r t e r l y U p d at e f o r 2 0 1 3 D u r a b l e M e d i c a l Eq u i p m e n t,
Prosthetics, Orthotics, and Supplies (DMEPOS) Fee Schedule . . . . . . . . . 75
Revised: MM8155 - Update to Chapter 15 of the Program Integrity Manual (PIM)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Revised: MM8182 - Standardizing the Standard - Operating Rules
for Code Usage in Remittance Advice . . . . . . . . . . . . . . 78
Revised: SE0711 – Reminder - Medicare Now Provides Coverage for Eligible
Medicare Beneficiaries of a One -Time Ultrasound Screening for Abdominal
Aor tic Aneur ysms (AAA) When Referred for this Screening as a Result of the
Initial Preventive Physical Examination (“Welcome to Medicare” Physical Exam)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Revised: SE1305 - Full Implementation of Edits on the Ordering/Referring Providers in
Medicare Part B, DME, and Part A Home Health Agency (HHA) Claims (Change Requests
6417, 6421, 6696, and 6856) . . . . . . . . . . . . . . . . . . . . . . . . . . 83
SE1303 - Information on the National Physician Payment Transparency Program:
O p e n Pay m e n t s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 1
Spiracur SNaP Wound Care System . . . . . . . . . . . . . . . . . . . . . . . . 94
1st Quarter Update Part B Not Otherwise Classified Drug Fee
Schedule 2013 Payment Allowance Limits for Medicare Part B Not
Otherwise Classified (NOC) Drugs
Effective January 1, 2013 through March 31, 2013
Revised: 06-03-2013
Name of Drug and EXACT Dosage Given MUST be in Block 19 (paper), as an Attachement, or Narrative
Field (EMC)
NOTE 1: Payment allowance limits subject to the ASP methodology are based on 2Q12 ASP data.
NOTE 2: Providers should contact their local Medicare contractor processing the claim for the most appropriate
unlisted/unclassified HCPCS code to use in reporting these drugs to Medicare.
NOTE 3: The absence or presence of a HCPCS code and the payment allowance limits in this table does not
indicate Medicare coverage of the drug. Similarly, the inclusion of a payment allowance limit within a specific
column does not indicate Medicare coverage of the drug in that specific category. These determinations shall
be made by the local Medicare contractor processing the claim.
Note 4: ** - Carrier Priced
Changes In Bold
DRUG NAME
Abatacept (Orencia) The subcutaneous form of
abatacept is considered self-administered
Ado-Trastuzumab Emtansine (Kadcyla) covered
indications: HER2 -positive, metastatic breast
cancer (174.0-175.9)
Alfentanil Hydrochloride (Alfenta)
Alglucosidase Alfa (Myozyme)
Allopurinol Sodium (Aloprim) ICD-9’s 274.9 or
790.6 plus the ICD-9 for the neoplasm. Need
name of chemotherapy agent causing the
elevation of uric acid and a statement as to why
patient can not tolerate oral form of the drug.
Afinitor (see Everolimus)
NDC
NUMBER
DOSAGE
Current PAR
Current
NON-PAR
Notes
10 mgs.
$293.998
$279.298
Added
March
2013
$2.143
$2.036
$317.236
$301.374
500
mcg/5 ml
10 mg
500 mg/
SDV
code
J0178
Aflibercept (see EYLEA)
Amidate (see Etomidate)
Amino Acid
Amino Acid
Aminocaproic Acid
Arginine Hydrochloride (R-Gene 10)
Arzerra (see Ofatumumab)
** Ascorbic Acid (Vitamin C) Non-covered by
Carrier
** Atenolol (Tenormin) ICD-9’s = 401.0 - 429.9
Atropine Sulfate / Edrophonium Chloride
Avastin (See Bevacizumab)
Aztreonam (Azactam)
** Bacitracin (Bacim)
500 ml
1000 ml
250 mg
300 ml
0.5 mg
/ ml
10 mg
500 mg
50,000 U
$21.110
$35.190
$0.040
$11.225
$20.055
$33.431
$0.038
$10.664
$0.800
$0.760
$1.651
$1.568
$13.653
$10.170
$12.970
$9.662
This newsletter should be shared with all health care practitioners and managerial members of the provider/supplier staff.
Newsletters issued after January 1997 are available at no cost from our website at www.cgsmedicare.com.
Medicare Bulletin – GR 2013-07
- page 3 -
July 2013
Belimumab (Benlysta) Covered ICD-9: 710.0
Beltatacept (Nulojix) Covered indications: V420
and 075 or 996.52
Benlysta (see Belimumab)
Berinert (see C1 Esterase Inhibitor)
Bevacizumab (Avastin) CPT 67028 must be on
claim or in history; allow if billed with J3490 or
J3590 and the ICD-9 requirements from one
of the following codes: 115.02, 115.12, 115.92,
362.01 - 362.07 (any), 362.16, 362.35 - 362.37
(any), 362.42, 362.52 or 362.83.
10 mg
59730-650301
59730-650201
Bivigam
Bivigam
Bretylium Tosylate (Bretylol)
Brevibloc (see Esmolol Hydrochloride)
Brovana (see Arformoterol Tartrate)
Bumetanide (Bumex)
Bupivacaine Hcl, 0.25%, 2 ml (Considered Part
of Procedure)
Bupivacaine Hcl, 0.50%, 2 ml (Considered Part
of Procedure)
Bupivacaine, Sterile, 0.25%/10ml (Sensorcaine,
Sterile) Allowed when billed with 51700, 51720,
62310, 62311, 62318, 62319, 62368, 64400 64484, 64505 - 64530, 77003, 95990, or 96530.
When billed with other procedures, considered
part of procedure performed.
62310, 62311, 62318, 62319, 62368, 64400 64484, 64505 - 64530, 77003, 95990, or 96530.
62310, 62311, 62318, 62319, 62368, 64400 64484, 64505 - 64530, 77003, 95990, or 96530.
Cabazitaxel (Jevtana®)
Calciferol (see Ergocalciferol D2)
Calcium Chloride
Cardizem IV (see Diltiazem Hydrochloride)
Carfilzomib (Kyprolis) covered ICD-9 203.00 or
203.02
** Cefamanadole Nafate (Mandol)
** Cefoperazone Sodium (Cefobid)
Cefotetan Disodium (Cefotan)
Chirocaine (see Levobupivacaine
Hydrochloride)
Cimetidine Hcl. (Tagamet)
Cimzia (see Certolizumab Pegol)
Clavulanate Potassium / Ticarcillin Disodium
Clevidipine Butyrate
Clindamycin Phosphate (Cleocin)
Clorpactin WCS-90 (see Oxychlorosene Sodium)
250 mg.
$978.380
$929.461
N/A
$60.000
$57.000
100 ml
$63.579
$60.400
50 ml
$63.579
$60.400
5 mg
$0.175
$0.166
0.25 mg
$0.171
$0.162
0.25% - 1
ml
$0.077
$0.073
0.50% - 1
ml
$0.077
$0.073
0.75% - 1
ml
$0.077
$0.073
100 mg
/ ml
$0.159
$0.151
60 mg
$1,669.606
1 gm
1 gm
1 gm
$8.610
$16.380
$11.376
$8.180
$15.561
$10.807
150 mg
$1.064
$1.011
0.1 - 3 gm
1 mg
150 mg
$9.618
$2.957
$1.618
$9.137
$2.809
$1.537
added
June 2013
added
June 2013
1 mg
July 2013
- page 4 -
Copper Sulfate
Cystografin (see Diatrizoate Meglumine)
Dantrolene Sodium
Depacon (see Valproate Sodium)
Denileukin Difitox (Ontak) (For 300 mcg, use
code J9160)
Denosumab (Prolia ™ or Xgeva) If Prolia ™,
covered ICD-9 = 733.01; if Xgeva, covered ICD-9
= 198.5.
Dextrose 2.5%
Dextrose 5%
Dextrose 10%
Dextrose 50%
** Dextrose / Nitroglycerin 5%-20 mg/ 100
ml/250 ml
** Dextrose 5% / Sodium Chloride
Diatrizoate Meglumine (Cystografin)
Diltiazem Hydrochloride (Cardizem IV)
Diprivan (see Propofol)
Doxapram Hydrochloride (Dopram)
Doxycycline Hyclate
Edecrin Sodium (see Ethacrynate Sodium)
Edrophonium Chloride (Tensilon) (Allow for
ICD9 - 358.0)
Elaprase (see Idursulfase)
Emend for Injection (see Fosaprepitant
Dimeglumine)
Enalaprilat (Vasotec IV)
Eovist (see Gadoxetate Disodium)
Ergocalciferol D2 (Calciferol) ICD-9’s = 579.8 or
579.9 Allowed when administered in physician’s
office
Eribulin Mesylate (Halaven) - Covered ICD-9’s =
174.0 - 174.9
Esmolol Hydrochloride (Brevibloc) Covered
ICD-9 = 427.89 (Dosage change from 100 mg to
10 mg.)
Esomeprazole Sodium (Nexium IV) Covered
ICD-9’s = 530.10 - 530.19 or 530.81 when
administered in the physician’s office.
Estradiol
** Estradiol Pellets
Ethacrynate Sodium (Edecrin Sodium)
** Ethiodized Oil (Ethiodol)
Etomidate (Amidate)
Everolimus (Afinitor / Zortress) - Non-Covered;
Oral drug considered as self-administered.
EYLEA (see Aflibercept)
Famotidine (Pepcid)
Firazyr (see Icantibant)
Firmagon (see Degarelix)
Flagyl IV (see Metronidazole In Nacl.)
Floxin IV (see Ofloxacin)
Flumazenil (Mazicon, Romazicon)
Folic Acid
0.4 mg
$0.125
$0.119
20 mg
$78.800
$74.860
150 mcg
$595.430
$565.659
2.50%
5%
500 ml
50 ml
20
mg/100
ml/250 ml
1000 ml
10 ml
5 mg
$7.680
$7.860
$10.000
$0.101
$7.296
$7.467
$9.500
$0.096
$6.320
$6.004
$11.220
$2.10
$0.209
$10.659
$2.00
$0.199
20 mg
100 mg
$2.195
$11.195
$2.085
$10.635
10 mg
$2.420
$2.299
1.25 mg
$1.142
$1.085
500,000
IU/ 1ml
$29.840
$28.348
10 mg
$0.797
$0.757
20 MG
$1.770
$1.682
1 gram
Per Pellet
50 mg
1 ml
2 mg
$13.300
Invoice
$19.040
$8.060
$0.695
$12.635
Invoice
$18.088
$7.657
$0.660
10 mg
$0.389
$0.370
0.1 mg
0.5 mg
5 mg
$1.179
$42.830
$2.353
$1.120
$40.689
$2.235
1 mg
0.1 mg
- page 5 -
July 2013
Folotyn (see Pralatrexate)
Fospropofol Disodium injection (Lusedra)
Gammaked injection
Gammaplex (see Human Immune Globulin
Intravenous)
Glucarpidase
Glycopyrrolate (Robinul)
Halaven (see Eribulin Mesylate)
** Heparin Sodium
Hetastarch Sodium Cl., 6 gm/500 ml
Hexaminolevulinate Hydrochloride - Covered
for ICD-9’s 188.0 through 188.9
Hizentra (see Immune Globulin Subcutaneous)
Human Immune Globulin Intravenous
(Gammaplex)
Hydroxocobalamin - Covered when billed with
J9305.
Icantibant (Firazyr) - Usually considered selfadministered
Ilaris (see Canakinumab)
Immune Globulin (see Bivigam)
** Inamrinone Lactate
IncobotulinumtoxinA (Xeomin) - Covered for
the treatment of Genetic torsion dystonia
(333.6) and Blepharospasm (333.81)
INTEGRA™ Bilayer Matrix Wound Dressing Covered Indications = 757.39, 941.20-941.21,
941.24-941.31, 941.34-941.41, 941.44-941.51,
941.54-941.59, 942.20-942.59, 943.20-943.59,
944.20-944.58, 945.20-945.59, 946.2-946.5,
948.00-948.99
Invega® Sustenna® (see Paliperidone Palmitate
injection)
Ipilimumab (Yervoy) - Covered for unresectable
or metastatic melanoma.
Isoproterenol Hydrochloride (Isuprel)
Isoptin IV (see Verapamil Hydrochloride)
Istodax (see Romidepsin)
Isuprel (see Isoproterenol Hydrochloride)
Jetrea (Ocriplasmin) Covered indication
379.27(vitreomacular adhesion)
Jevtana® (see Cabazitaxel)
35 mg
500 mg
$1.272
$37.484
$1.208
$35.610
10 units
0.2 mg
$233.730
$0.375
$222.044
$0.356
100 units
6 gm
100 mg,
per study
dose
$0.032
$23.040
$0.030
$21.888
$741.576
$704.497
$1.212
$1.151
IV
1000
mcg/ml
59730-650301
59730-650201
added
June 2013
added
June 2013
100 ml
50 ml
5 mg
$4.050
$3.848
$24.609
$23.379
0.2 mg
$2.250
$2.138
0.2 ml
SDV
$4,187.000
$3,977.650
1 Unit
1 sq cm
1mg
Added
March
2013
Kadcyla (see Ado-Trastuzumab Emtansine)
Kalbitor (see Ecallantide)
Kenalog (see Triamcinolone Acetonide)
Keppra intraveneous (see Levetiracetam)
Ketamine Hydrochloride (Ketalar) Allowed
when billed on same day as 20550-20610,
62289, 62298, 62368, 95990, or 96530.
Kyprolis (see Carfilzomib)
Krystexxa (see Pegloticase)
10 mg
$0.067
$0.064
July 2013
- page 6 -
Labetalol Hydrochloride (Trandate,
Normodyne) Covered if given IV in the office
for control of BP in severe hypertension. Patient
is normally switched to oral for maintainance
doses.
** Levobupivacaine Hydrochloride (Chirocaine)
Allowed separately when billed on same day
as 51700, 51720, 62310, 62311, 62318, 62319,
62368, 64400 - 64484, 64505-64530, 76003,
95990, or 96530. Not payable separately when
billed with any other procedures
** Levophed Bitartrate (see Norepinephrine
Bitartrate)
** Levothyroxine Sodium (Synthroid) Need
statemnt on claim as to why patient can’t take
oral form of drug.
Lidocaine - Allowed separately when billed
on same day as 51700, 51720, 62310, 62311,
62318, 62319, 62368, 64400 - 64484, 64505 64530, 77033, 95990, or 96530. Not payable
when billed with any other procedure.
Lopressor (see Metoprolol Tartrate)
Lusedra (see Fospropofol Disodium injection)
Mandol (see Cefamanadole Nafate)
Marqibo (see Vincristine sulfate Liposome)
Mazicon (see Flumazenil)
Methylnaltrexone Bromide (Relistor) Noncovered by carrier.
Metoprolol Tartrate (Lopressor) Covered
when given IV with Dobutamine J1250 during
Dobutamine Stress Test.
Metronidazole Hcl. (Flagyl IV) IV in the office.
Covered for ICD-9’s= 001.0-009.3, 040.0-041.9,
481-482.9, 567.0-567.9, 599.0-599.9, 615.0615.9.
Miconazole (Monistat IV) 10 mg
Minocycline Hydrochloride (Non-covered oral
drug)
Monistat IV (see Miconazole)
Morrhuate Sodium
Myozyme (see Alglucoside Alfa)
Nafcillin Sodium (Nallpen) (Dosage Change
from 500 mg to 1 gm)
Nalmefene Hydrochloride (Revex)
Netilmicin Sulfate (Netromycin), 150 mg
Nexium IV (see Esomeprazole Sodium)
Nitroglycerin IV – Allowed in emergency
situations.
Nodolo & Tusal (see Sodium Thiosalicylate)
** Norepinephrine Bitartrate (Levophed
Bitartrate) Allow in emergency situations.
Norcuron (see Vecuronium Bromide)
5 mg
$0.149
$0.142
2.5 mg/ml
$0.310
$0.295
0.5 mg
$62.010
$58.910
1 ml
$0.143
$0.136
1 mg
$0.159
$0.151
500 mg
$1.091
$1.036
Invoice
Invoice
50 mg
$2.105
$2.000
1 gm
$8.058
$7.655
10 mcg
$0.276
Invoice
$0.262
Invoice
5 mg
$0.374
$0.355
1 mg
$2.161
$2.053
- page 7 -
July 2013
Normal Saline (Sterile Water)
Normodyne (see Labetalol Hydrochloride)
Nplate™ (see Romiplostim)
Nulojix (see Beltatacept)
Ocriplasmin Intraviteral Injection (see Jetrea)
Ofloxacin (Floxin IV), 20 mg
Olanzapine short-acting intramuscular injection
(Zyprexa IM) Covered indications = 295.01 295.84 when administered in the physicians
office.
Omacetaxine Mepesuccinate (Synribo) covered
indications 205.10 without having achieved
remission, failed remission or 205.12 in relapse
Ontak (see Denileukin Difitox)
Optison
Orencia (see Abatacept)
** Oxychlorosene Sodium (Clorpactin WCS-90)
Ozurdex (see Dexamethasone Intravitreal
Implant)
Pantoprazole Sodium, IV (Protonix IV) Need
statement as to why patient is not able to take
oral form.
** Peginterferon Alfa-2A/Isopropyl Alchol
(Pegasys®) Covered indication 070.54 when
administered in the office.
Peginterferon Alfa-2B (PEG-Intron) 50 mcg
Covered indication 070.54 when administered
in the office.
** Peginterferon Alfa-2B, 80mcg
Pegloticase (Krystexxa) When billed with J3490
or J3590, covered for chronic gout, ICD-9’s
274.00 through 274.03
** Pegvisomant for Injection (Somavert)
Considered Usually Self-Administered
Pepcid (see Famotidine)
Perjeta (see Pertuzumab)
Pertuzumab (Perjeta) Covered ICD-9 174.0 175.9 in combination with Trastuzumab J9355
and Docetaxel J9171
Potassium Acetate
Potassium Phosphate
Procaine Hydrochloride
Prolia ™ (see Denosumab)
Propofol (Diprivan)
Protonix IV (see Pantoprazole Sodium)
Provenge (see Sipuleucel-T)
Qutenza (see Capsaicin 8% Patch)
** R-Gene 10 (see Arginine Hcl.)
Relistor (see Methylnaltrexone Bromide)
Revex (see Nalmefene Hydrochloride)
Rexolate & Arthrolate (see Sodium
Thiosalicylate)
RiaSTAP (see Fibrinogen Concentrate Human)
Rifampin
Robinul (see Glycopyrrolate)
50 ml
$1.430
$1.359
Invoice
Invoice
0.5 mg
$1.632
$1.550
3.5 mg
$885.100
$840.845
Invoice
Invoice
1 gm
$1.850
$1.758
40 mg
$4.511
$4.285
180mcg/
ml
$480.273
$456.259
50 mcg
$320.610
$304.580
80 mcg
120 mcg
150 mcg
$336.600
$353.460
$371.120
$319.770
$335.787
$352.564
10 mg/ml
$102.327
$97.211
2 meq
3 mmol
1%
2%
$0.027
$0.043
$2.360
$3.400
$0.026
$0.041
$2.242
$3.230
10 mg
$0.118
$0.112
600 mg
$41.855
$39.762
Added
March
2013
1mg
July 2013
- page 8 -
Romazicon (see Flumazenil)
Sarracenia Purpura Non-covered by Carrier
Sensorcaine, Sterile (see Bupivicaine, Sterile)
Sipuleucel-T (Provenge) ICD-9 = 185
Sodium Acetate
** Sodium Bicarbonate, PF (NACH03)
Sodium Bicarbonate, 8.4% (NACH03)
Sodium Chloride, Hypertonic
** Sodium Tetradecyl Sulfate (Sotradecol)
** Sodium Thiosalicylate (Rexolate & Arthrolate,
Nodolo & Tusal)
Sodium Thiosulfate
Soliris (see Eculizumab)
Somatuline Depot (see Lanreotide)
** Somavert (see Pegvisomant for Injection)
Stelara (see Ustekinumab)
Sterile Saline / Water
** Sterile Saline / Water, 1000 ml
** Sufentanil Citrate (Sufenta) Separate
payment allowed when billed with 62310,
62311, 62318, 62319, 76005, 95990, or 96530.
If billed with any other procedures, it will be
considered part of the procedure and separate
payment will not be allowed.
Sulfamethoxazole/Trimethoprim (SMZ-TMP)
Documentation as to why the patient needs
to be on IV infusion instead of oral medication,
must be in block 19 or as an attachment for
paper claims or in the notepad for EMC claims.
SurgiMend
Per
infusion
(minimum
50 million
cells)
2 meq
7.5%/50
ml
50 ml
250 cc
$0.043
$0.041
$2.730
$2.594
$0.122
$0.705
Invoice
$0.116
$0.670
Invoice
50 mg
$0.970
$0.922
100 mg
$0.155
$0.147
5 cc
$0.052
$0.049
1000 ml
50mcg/ml
$5.640
$9.810
$5.358
$9.320
400 - 80
mg
$0.311
$0.295
0.5 sq cm
$11.776
$11.187
Added
March
2013
Synribo (see Omacetaxine Mepesuccinate)
Synthroid (see Levothyroxine Sodium)
Synvisc-One (see Hylan G-F 20)
Tagamet (see Cimetidine Hydrochloride)
Taliglucurase Alfa
Tenormin (see Atenolol)
Tensilon (see Edrophonium Chloride)
Testosterone
** Testosterone Pellets (Testopel)
Tetanus Toxoid (use codes 90702, 90703, or
90718)
Tetracycline
Torisel (see Temsirolimus)
Trandate (see Labetalol Hydrochloride)
Treanda (see Bendamustine Hydrochloride)
Truxton (see Prednisolone Acetate)
Tyvaso (see Treprostinil inhalation)
Vaccinia IVIG (see Human Immune Globulin
Intravenous)
10 units
$30.904
37.5 mg
Per Pellet
$0.110
Invoice
$0.105
Invoice
Invoice
Invoice
- page 9 -
July 2013
Valproate Sodium (Depacon) IV, Covered ICD9’s
= 345.00 - 345.91, Allowed when administered
IV, in the physician’s office. (Dosage change
from 500 mg to 100 mg)
Vasopressin
Vasotec IV (see Enalaprilat)
Vectibix (see Panitumumab)
Vecuronium Bromide (Norcuron)
Verapamil Hydrochloride (Isoptin IV)
VIBATIV™ (see Telavancin Injection)
Vincristine Sulfate Liposome (Marquibo)
covered ICD-9: 204.00-204.02
** Vitamin B Complex
** Vitamin C (see Ascorbic Acid) Non-covered
by Carrier
Vivaglobin (see Immune Globulin
Subcutaneous)
VPRIV™ (see Velaglucerase alfa for injection)
Wilate (Human coagulation factor VIII (FVIII)
and von Willebrand factor (VWF) powder and
solvent for solution for injection) Covered ICD9: 286.4
Xeomin (see IncobotulinumtoxinA)
Xgeva (see Denosumab)
Xiaflex (see Collagenase Clostridum
Histolyticum)
Xyntha (see Antihemophilic Factor (Recomb)
Plasma/Albumin-Free)
Yervoy (see Ipilimumab)
Zaltrap (see Ziv-Aflibercept)
Ziv-Aflibercept (Zaltrap) covered ICD-9 153.0 153.7 or 154.0 - 154.2
Zortress (see Everolimus)
Zyprexa IM (see Olanzapine)
HOCM <= 149 MG/ML
HOCM 200 - 249 MG/ML
HOCM >= 400 MG/ML
100 mg
$0.558
$0.530
20 units
$1.254
$1.191
1 mg
2.5 mg
$0.487
$3.167
$0.463
$3.009
2.25 mg.
Invoice
Up to 3 ml
$0.930
$0.884
1 IU
VWF:RCO
100 mg.
$1,611.200
1 ml
1 ml
1 ml
1 ml
1 ml
1 ml
$0.041
$0.093
$0.100
$0.104
$0.107
$0.191
$0.039
$0.088
$0.095
$0.099
$0.102
$0.181
2nd Quarter Update Part B Not Otherwise Classified Drug Fee
Effective April 1, 2013 through June 30, 2013
Revised: 06-03-2013
Field (EMC)
July 2013
- page 10 -
Changes In Bold
DRUG NAME
Abatacept (Orencia) The
subcutaneous form of abatacept is
considered self-administered
Ado-Trastuzumab Emtansine
(Kadcyla) covered indications HER2positive, metastatic breast cancer
(174.0-175.9)
Allopurinol Sodium (Aloprim) ICD9’s 274.9 or 790.6 plus the ICD-9
for the neoplasm. Need name
of chemotherapy agent causing
the elevation of uric acid and a
statement as to why patient can not
tolerate oral form of the drug.
Amino Acid
Amino Acid
Aminocaproic Acid
** Ascorbic Acid (Vitamin C) Noncovered by Carrier
** Atenolol (Tenormin) ICD-9’s =
401.0 - 429.9
Atropine Sulfate / Edrophonium
Chloride
Aztreonam (Azactam)
Belimumab (Benlysta) Covered ICD9: 710.0
Beltatacept (Nulojix) Covered
indications: V420 and 075 or 996.52
Bevacizumab (Avastin) CPT 67028
must be on claim or in history; allow
if billed with J3490 or J3590 and the
ICD-9 requirements from one of the
following codes: 115.02, 115.12,
115.92, 362.01 - 362.07 (any), 362.16,
362.35 - 362.37 (any), 362.42, 362.52
or 362.83.
Bivigam
NDC
Number
DOSAGE
Current PAR
Current
NON-PAR
Notes
10 mgs.
$293.998
$279.298
Added March 2013
500 mcg/5 ml
10 mg
500 mg/SDV
$1.887
$1.793
$303.245
$288.083
code for 2013-J0178
597306503-01
500 ml
1000 ml
250 mg
300 ml
$21.110
$35.190
$0.081
$11.225
$20.055
$33.431
$0.077
$10.664
0.5 mg / ml
$0.800
$0.760
10 mg
$1.651
$1.568
500 mg
50,000 U
10 mg
$13.804
$10.170
$13.114
$9.662
250 mg.
$978.380
$929.461
N/A
$60.000
$57.000
100 ml
$63.579
$60.400
added June 2013
- page 11 -
July 2013
Bivigam
597306502-01
Brevibloc (see Esmolol
Hydrochloride)
Bumetanide (Bumex)
Bupivacaine Hcl, 0.25%, 2 ml
(Considered Part of Procedure)
Bupivacaine Hcl, 0.50%, 2 ml
(Considered Part of Procedure)
Bupivacaine, Sterile, 0.25%/10ml
(Sensorcaine, Sterile) Allowed when
billed with 51700, 51720, 62310,
62311, 62318, 62319, 62368, 64400
- 64484, 64505 - 64530, 77003,
95990, or 96530. When billed with
other procedures, considered part of
procedure performed.
billed with 51700, 51720, 62310,
62311, 62318, 62319, 62368, 64400
- 64484, 64505 - 64530, 77003,
billed with 51700, 51720, 62310,
62311, 62318, 62319, 62368, 64400
- 64484, 64505 - 64530, 77003,
Calcium Chloride
Cardizem IV (see Diltiazem
Hydrochloride)
Carfilzomib (Kyprolis) covered ICD-9
203.00 or 203.02
Hydrochloride)
Clavulanate Potassium / Ticarcillin
Disodium
Clorpactin WCS-90 (see
Oxychlorosene Sodium)
Copper Sulfate
Cystografin (see Diatrizoate
Meglumine)
Dantrolene Sodium
50 ml
$63.579
$60.400
5 mg
$0.175
$0.166
0.25 mg
$0.215
$0.204
0.25% - 1 ml
$0.087
$0.083
0.50% - 1 ml
$0.087
$0.083
0.75% - 1 ml
$0.087
$0.083
100 mg / ml
$0.159
$0.151
1 mg
$29.291
$27.826
1 gm
1 gm
1 gm
$8.610
$16.380
$11.376
$8.180
$15.561
$10.807
150 mg
$1.064
$1.011
0.1 - 3 gm
$10.790
$10.251
1 mg
150 mg
$2.873
$1.822
$2.729
$1.731
0.4 mg
$0.125
$0.119
20 mg
$78.800
$74.860
added June 2013
1 mg
Updated April 2013
July 2013
- page 12 -
Denileukin Difitox (Ontak) (For 300
mcg, use code J9160)
Denosumab (Prolia ™ or Xgeva) If
Prolia ™, covered ICD-9 = 733.01; if
Xgeva, covered ICD-9 = 198.5.
Dextrose 2.5%
Dextrose 5%
Dextrose 10%
Dextrose 50%
** Dextrose / Nitroglycerin 5%-20
mg/ 100 ml/250 ml
Diltiazem Hydrochloride (Cardizem
IV)
Doxycycline Hyclate
Edecrin Sodium (see Ethacrynate
Sodium)
Edrophonium Chloride (Tensilon)
(Allow for ICD9 - 358.0)
Emend for Injection (see
Fosaprepitant Dimeglumine)
Ergocalciferol D2 (Calciferol) ICD9’s = 579.8 or 579.9 Allowed when
administered in physician’s office
Eribulin Mesylate (Halaven) Covered ICD-9’s = 174.0 - 174.9
Esmolol Hydrochloride (Brevibloc)
Covered ICD-9 = 427.89 (Dosage
change from 100 mg to 10 mg.)
Esomeprazole Sodium (Nexium IV)
Covered ICD-9’s = 530.10 - 530.19
or 530.81 when administered in the
physician’s office.
Estradiol
Ethacrynate Sodium (Edecrin
Sodium)
Etomidate (Amidate)
Everolimus (Afinitor / Zortress) Non-Covered; Oral drug considered
as self-administered.
Famotidine (Pepcid)
Folic Acid
150 mcg
$595.430
$565.659
2.50%
5%
500 ml
50 ml
20 mg/100
ml/250 ml
1000 ml
10 ml
5 mg
$7.680
$7.860
$10.000
$0.101
$6.320
$7.296
$7.467
$9.500
$0.096
$6.004
$11.220
$2.10
$0.212
$10.659
$2.00
$0.201
20 mg
100 mg
$2.195
$12.774
$2.085
$12.135
10 mg
$2.420
$2.299
1.25 mg
$1.142
$1.085
500,000 IU/
1ml
$29.840
$28.348
10 mg
$0.781
$0.742
20 MG
$2.422
$2.301
1 gram
Per Pellet
50 mg
$13.300
Invoice
$19.040
$12.635
Invoice
$18.088
1 ml
2 mg
$8.060
$0.655
$7.657
$0.622
10 mg
$0.366
$0.348
0.1 mg
0.5 mg
5 mg
$1.039
$42.830
$2.276
$0.987
$40.689
$2.162
1 mg
0.1 mg
- page 13 -
July 2013
Fospropofol Disodium injection
(Lusedra)
Gammaked injection
Gammaplex (see Human Immune
Globulin Intravenous)
Glucarpidase
** Heparin Sodium
Hexaminolevulinate Hydrochloride
- Covered for ICD-9’s 188.0 through
188.9
Hizentra (see Immune Globulin
Subcutaneous)
Human Immune Globulin
Intravenous (Gammaplex)
Hydroxocobalamin - Covered when
billed with J9305.
Icantibant (Firazyr) - Usually
considered self-administered
IncobotulinumtoxinA (Xeomin)
- Covered for the treatment of
Genetic torsion dystonia (333.6) and
Blepharospasm (333.81)
INTEGRA™ Bilayer Matrix Wound
Dressing - Covered Indications
= 757.39, 941.20-941.21, 941.24941.31, 941.34-941.41, 941.44941.51, 941.54-941.59, 942.20942.59, 943.20-943.59, 944.20944.58, 945.20-945.59, 946.2-946.5,
948.00-948.99
Invega® Sustenna® (see Paliperidone
Palmitate injection)
Ipilimumab (Yervoy) - Covered
for unresectable or metastatic
melanoma.
Isoptin IV (see Verapamil
Hydrochloride)
Isuprel (see Isoproterenol
Hydrochloride)
Jetrea (Ocriplasmin) Covered
indication 379.27 (vitreomacular
adhesion)
Kadcyla (see Ado-Trastuzumab
Emtansine)
Kenalog (see Triamcinolone
Acetonide)
35 mg
$1.272
$1.208
500 mg
$37.484
$35.610
10 units
0.2 mg
$233.730
$0.622
$222.044
$0.591
100 units
6 gm
100 mg, per
study dose
$0.032
$23.040
$741.576
$0.030
$21.888
$704.497
$1.212
$1.151
IV
1000 mcg/ml
597306503-01
597306502-01
100 ml
added June 2013
50 ml
added June 2013
5 mg
1 Unit
$4.050
$3.848
1 sq cm
$27.536
$26.159
0.2 mg
$2.250
$2.138
0.2 ml SDV
$4,187.000
$3,977.650
1mg
Added March 2013
July 2013
- page 14 -
Keppra intraveneous (see
Levetiracetam)
Ketamine Hydrochloride (Ketalar)
Allowed when billed on same day as
20550-20610, 62289, 62298, 62368,
95990, or 96530.
Normodyne) Covered if given IV in
the office for control of BP in severe
hypertension. Patient is normally
switched to oral for maintainance
doses.
** Levobupivacaine Hydrochloride
(Chirocaine) Allowed separately
when billed on same day as 51700,
51720, 62310, 62311, 62318, 62319,
62368, 64400 - 64484, 64505-64530,
76003, 95990, or 96530. Not payable
separately when billed with any
other procedures
** Levophed Bitartrate (see
Norepinephrine Bitartrate)
** Levothyroxine Sodium (Synthroid)
Need statemnt on claim as to why
patient can’t take oral form of drug.
Lidocaine - Allowed separately when
billed on same day as 51700, 51720,
62310, 62311, 62318, 62319, 62368,
64400 - 64484, 64505 - 64530, 77033,
95990, or 96530. Not payable when
billed with any other procedure.
Lusedra (see Fospropofol Disodium
injection)
Marqibo (see Vincristine sulfate
Liposome)
Methylnaltrexone Bromide (Relistor)
Non-covered by carrier.
Metoprolol Tartrate (Lopressor)
Covered when given IV with
Dobutamine J1250 during
Dobutamine Stress Test.
Metronidazole Hcl. (Flagyl IV) IV
in the office. Covered for ICD-9’s=
001.0-009.3, 040.0-041.9, 481-482.9,
567.0-567.9, 599.0-599.9, 615.0615.9.
Minocycline Hydrochloride (Noncovered oral drug)
Morrhuate Sodium
Nafcillin Sodium (Nallpen) (Dosage
Change from 500 mg to 1 gm)
10 mg
$0.067
$0.064
5 mg
$0.211
$0.200
2.5 mg/ml
$0.310
$0.295
0.5 mg
$62.010
$58.910
1 ml
$0.143
$0.136
1 mg
$0.270
$0.257
500 mg
$1.128
$1.072
Invoice
Invoice
50 mg
$2.105
$2.000
1 gm
$8.058
$7.655
10 mcg
$0.276
$0.262
- page 15 -
July 2013
Netilmicin Sulfate (Netromycin), 150
mg
Nexium IV (see Esomeprazole
Sodium)
Nitroglycerin IV – Allowed in
emergency situations.
Nodolo & Tusal (see Sodium
Thiosalicylate)
** Norepinephrine Bitartrate
(Levophed Bitartrate) Allow in
emergency situations.
Normodyne (see Labetalol
Hydrochloride)
Ocriplasmin Intraviteral Injection
(see Jetrea)
Olanzapine short-acting
intramuscular injection (Zyprexa
IM) Covered indications = 295.01
- 295.84 when administered in the
physicians office.
Omacetaxine Mepesuccinate
(Synribo) covered indications 205.10
without having achieved remission,
failed remission or 205.12 in relapse
Optison
** Oxychlorosene Sodium
(Clorpactin WCS-90)
Ozurdex (see Dexamethasone
Intravitreal Implant)
Pantoprazole Sodium, IV (Protonix
IV) Need statement as to why patient
is not able to take oral form.
** Peginterferon Alfa-2A/Isopropyl
Alchol (Pegasys®) Covered indication
070.54 when administered in the
office.
Peginterferon Alfa-2B (PEG-Intron)
50 mcg Covered indication 070.54
when administered in the office.
Pegloticase (Krystexxa) When billed
with J3490 or J3590, covered for
chronic gout, ICD-9’s 274.00 through
274.03
** Pegvisomant for Injection
(Somavert) Considered Usually SelfAdministered
Invoice
Invoice
5 mg
$0.362
$0.344
1 mg
$2.161
$2.053
50 ml
$1.430
$1.359
0.5 mg
Invoice
$1.598
Invoice
$1.518
3.5 mg
$885.100
$840.845
Invoice
Invoice
1 gm
$1.850
$1.758
40 mg
$4.511
$4.285
180mcg/ml
$480.273
$456.259
50 mcg
$320.610
$304.580
80 mcg
120 mcg
150 mcg
1mg
$336.600
$353.460
$371.120
$319.770
$335.787
$352.564
July 2013
- page 16 -
Pertuzumab (Perjeta) Covered ICD-9
174.0 - 175.9 in combination with
Trastuzumab J9355 and Docetaxel
J9171
Potassium Acetate
Potassium Phosphate
Propofol (Diprivan)
Protonix IV (see Pantoprazole
Sodium)
Relistor (see Methylnaltrexone
Bromide)
Revex (see Nalmefene
Hydrochloride)
Thiosalicylate)
RiaSTAP (see Fibrinogen Concentrate
Human)
Rifampin
Sarracenia Purpura Non-covered by
Carrier
Sensorcaine, Sterile (see Bupivicaine,
Sterile)
10 mg/ml
$102.269
$97.156
2 meq
3 mmol
1%
2%
$0.027
$0.043
$2.360
$3.400
$0.026
$0.041
$2.242
$3.230
10 mg
$0.123
$0.117
600 mg
$38.934
$36.987
Sodium Acetate
** Sodium Tetradecyl Sulfate
(Sotradecol)
** Sodium Thiosalicylate (Rexolate &
Arthrolate, Nodolo & Tusal)
Sodium Thiosulfate
** Somavert (see Pegvisomant for
Injection)
** Sufentanil Citrate (Sufenta)
Separate payment allowed when
billed with 62310, 62311, 62318,
62319, 76005, 95990, or 96530. If
billed with any other procedures,
it will be considered part of the
procedure and separate payment
will not be allowed.
2 meq
7.5%/50 ml
50 ml
250 cc
$0.043
$2.730
$0.122
$0.703
Invoice
$0.041
$2.594
$0.116
$0.668
Invoice
50 mg
$0.970
$0.922
100 mg
$0.155
$0.147
5 cc
$0.052
$0.049
1000 ml
50mcg/ml
$5.640
$9.810
$5.358
$9.320
Per infusion
(minimum 50
million cells)
- page 17 -
July 2013
Sulfamethoxazole/Trimethoprim
(SMZ-TMP) Documentation as to
why the patient needs to be on IV
infusion instead of oral medication,
must be in block 19 or as an
attachment for paper claims or in the
notepad for EMC claims.
SurgiMend
Synribo (see Omacetaxine
Mepesuccinate)
Synthroid (see Levothyroxine
Sodium)
Tagamet (see Cimetidine
Hydrochloride)
Taliglucurase Alfa
Testosterone
Tetanus Toxoid (use codes 90702,
90703, or 90718)
Tetracycline
Trandate (see Labetalol
Hydrochloride)
Treanda (see
Bendamustine Hydrochloride)
Vaccinia IVIG (see Human Immune
Globulin Intravenous)
Valproate Sodium (Depacon) IV,
Covered ICD9’s = 345.00 - 345.91,
Allowed when administered IV,
in the physician’s office. (Dosage
change from 500 mg to 100 mg)
Vasopressin
Vincristine Sulfate Liposome
(Marquibo) covered ICD-9: 204.00204.02
** Vitamin B Complex
** Vitamin C (see Ascorbic Acid)
Non-covered by Carrier
Subcutaneous)
VPRIV™ (see Velaglucerase alfa for
injection)
Wilate (Human coagulation factor
VIII (FVIII) and von Willebrand factor
(VWF) powder and solvent for
solution for injection) Covered ICD9: 286.4
400 - 80 mg
$0.311
$0.295
0.5 sq cm
$11.885
$11.291
10 units
$30.904
37.5 mg
Per Pellet
$0.110
Invoice
$0.105
Invoice
Invoice
Invoice
100 mg
$0.558
$0.530
20 units
$1.214
$1.153
1 mg
2.5 mg
$0.433
$3.167
$0.411
$3.009
2.25 mg.
Invoice
Up to 3 ml
$0.930
$0.884
1 IU VWF:RCO
July 2013
- page 18 -
Histolyticum)
Xyntha (see Antihemophilic Factor
(Recomb) Plasma/Albumin-Free)
Ziv-Aflibercept (Zaltrap) covered
ICD-9 153.0 - 153.7 or 154.0 - 154.2
HOCM <= 149 MG/ML
HOCM >= 400 MG/ML
1 mg.
$15.572
1 ml
1 ml
1 ml
1 ml
1 ml
1 ml
$0.041
$0.093
$0.100
$0.104
$0.107
$0.191
Updated April 2013
$0.039
$0.088
$0.095
$0.099
$0.102
$0.181
4th Quarter Update Part B Not Otherwise Classified Drug Fee
Effective October 1, 2012 through December 31, 2012
Revised: 09/20/2012
Field (EMC)
Changes In Bold
DRUG NAME
Abatacept (Orencia) The subcutaneous form
of abatacept is considered self-administered
Actemra (see Tocilizumab)
Adcetris (see Brentuximab Vedotin)
Allopurinol Sodium (Aloprim) ICD-9’s 274.9 or
790.6 plus the ICD-9 for the neoplasm. Need
name of chemotherapy agent causing the
elevation of uric acid and a statement as to
why patient can not tolerate oral form of the
drug.
Current
PAR
Current NONPAR
500 mcg/5 ml
10 mg
$1.809
$1.719
Increase
Code for 2012: J0221
500 mg/SDV
$328.177
$311.768
Decrease
DOSAGE
Notes
- page 19 -
July 2013
Amino Acid
Amino Acid
Aminocaproic Acid
** Ascorbic Acid (Vitamin C) Non-covered by
Carrier
** Atenolol (Tenormin) ICD-9’s = 401.0 - 429.9
Atropine Sulfate / Edrophonium Chloride
Aztreonam (Azactam)
Belimumab (Benlysta) Covered ICD-9: 710.0
Beltatacept (Nulojix) Covered indications:
V420 and 075 or 996.52
Bevacizumab (Avastin) CPT 67028 must be
on claim or in history; allow if billed with
J3490 or J3590 and the ICD-9 requirements
from one of the following codes: 115.02,
115.12, 115.92, 362.01 - 362.07 (any), 362.16,
362.35 - 362.37 (any), 362.42, 362.52 or
362.83.
Brentuximab Vedotin (Adcetris) Covered
indications 200.60-200.68 or 201.00-201.98
Brevibloc (see Esmolol Hydrochloride)
Bumetanide (Bumex)
Bupivacaine Hcl, 0.25%, 2 ml (Considered
Part of Procedure)
Bupivacaine Hcl, 0.50%, 2 ml (Considered
Part of Procedure)
(Sensorcaine, Sterile) Allowed when billed
with 51700, 51720, 62310, 62311, 62318,
62319, 62368, 64400 - 64484, 64505 - 64530,
77003, 95990, or 96530. When billed with
with 51700, 51720, 62310, 62311, 62318,
62319, 62368, 64400 - 64484, 64505 - 64530,
with 51700, 51720, 62310, 62311, 62318,
62319, 62368, 64400 - 64484, 64505 - 64530,
code for 2012 Q2046
500 ml
1000 ml
250 mg
300 ml
$21.110
$35.190
$0.049
$11.225
$20.055
$33.431
$0.047
$10.664
0.5 mg / ml
10 mg
$0.800
$1.651
$0.760
$1.568
500 mg
50,000 U
10 mg
$13.997
$10.170
$13.297
$9.662
250 mg.
$978.380
Decrease
Increase
$929.461
Updated ICD-9
Coverage Effective:
01/01/2011
New Unit Price Per
Carrier Medical
Director Effective:
05/01/2011
N/A
$60.000
$57.000
1mg
$95.400
$90.630
5 mg
$0.175
$0.166
0.25 mg
$0.182
$0.173
Increase
0.25% - 1 ml
$0.091
$0.086
Increase
0.50% - 1 ml
$0.091
$0.086
Increase
0.75% - 1 ml
$0.091
$0.086
Increase
1 mg
July 2013
- page 20 -
Calcium Chloride
Cardizem IV (see Diltiazem Hydrochloride)
Carfilzomib (Kyprolis) covered ICD-9 203.00
or 203.02
Hydrochloride)
Clavulanate Potassium / Ticarcillin Disodium
Clorpactin WCS-90 (see Oxychlorosene
Sodium)
Copper Sulfate
Cystografin (see Diatrizoate Meglumine)
Dantrolene Sodium
Denileukin Difitox (Ontak) (For 300 mcg, use
code J9160)
Denosumab (Prolia ™ or Xgeva) If Prolia ™,
covered ICD-9 = 733.01; if Xgeva, covered
ICD-9 = 198.5.
Dextrose 2.5%
Dextrose 5%
Dextrose 10%
Dextrose 50%
** Dextrose / Nitroglycerin 5%-20 mg/ 100
ml/250 ml
Diltiazem Hydrochloride (Cardizem IV)
Doxycycline Hyclate
Edecrin Sodium (see Ethacrynate Sodium)
Edrophonium Chloride (Tensilon) (Allow for
ICD9 - 358.0)
Emend for Injection (see Fosaprepitant
Dimeglumine)
Ergocalciferol D2 (Calciferol) ICD-9’s = 579.8
or 579.9 Allowed when administered in
physician’s office
Eribulin Mesylate (Halaven) - Covered ICD-9’s
= 174.0 - 174.9
Esmolol Hydrochloride (Brevibloc) Covered
ICD-9 = 427.89 (Dosage change from 100 mg
to 10 mg.)
Esomeprazole Sodium (Nexium IV) Covered
ICD-9’s = 530.10 - 530.19 or 530.81 when
administered in the physician’s office.
Estradiol
$0.151
Decrease
100 mg / ml
$0.159
60 mg
$1,669.606
1 gm
1 gm
1 gm
$8.610
$16.380
$11.376
$8.180
$15.561
$10.807
150 mg
$1.064
$1.011
0.1 - 3 gm
1 mg
150 mg
$11.704
$2.958
$2.009
$11.119
$2.810
$1.909
Increase
Decrease
Increase
0.4 mg
$0.111
$0.105
Decrease
20 mg
$78.800
$74.860
150 mcg
$595.430
$565.659
Added September
2012
1 mg
2.50%
5%
500 ml
50 ml
20 mg/100
ml/250 ml
1000 ml
10 ml
5 mg
$7.680
$7.860
$10.000
$0.101
$7.296
$7.467
$9.500
$0.096
$6.320
$6.004
$11.220
$2.10
$0.167
$10.659
$2.00
$0.159
Increase
20 mg
100 mg
$1.695
$10.885
$1.610
$10.341
Decrease
Decrease
10 mg
$2.420
$2.299
1.25 mg
$1.142
$1.085
500,000 IU/ 1ml
$29.840
$28.348
0.1 mg
Decrease
10 mg
$0.778
$0.739
Increase
20 MG
$1.904
$1.809
Decrease
1 gram
$13.300
$12.635
- page 21 -
July 2013
Ethacrynate Sodium (Edecrin Sodium)
Etomidate (Amidate)
Everolimus (Afinitor / Zortress) - NonCovered; Oral drug considered as selfadministered.
Famotidine (Pepcid)
Folic Acid
Fospropofol Disodium injection (Lusedra)
Gammaked injection
Gammaplex (see Human Immune Globulin
Intravenous)
** Heparin Sodium
Hexaminolevulinate Hydrochloride - Covered
for ICD-9’s 188.0 through 188.9
Hizentra (see Immune Globulin
Subcutaneous)
Human Immune Globulin Intravenous
(Gammaplex)
Hydroxocobalamin - Covered when billed
with J9305.
Icantibant (Firazyr) - Usually considered selfadministered
IncobotulinumtoxinA (Xeomin) - Covered for
the treatment of Genetic torsion dystonia
(333.6) and Blepharospasm (333.81)
INTEGRA™ Bilayer Matrix Wound Dressing Covered Indications = 757.39, 941.20-941.21,
941.24-941.31, 941.34-941.41, 941.44-941.51,
941.54-941.59, 942.20-942.59, 943.20-943.59,
944.20-944.58, 945.20-945.59, 946.2-946.5,
948.00-948.99
Invega® Sustenna® (see Paliperidone
Palmitate injection)
Ipilimumab (Yervoy) - Covered for
unresectable or metastatic melanoma.
Isoptin IV (see Verapamil Hydrochloride)
Isuprel (see Isoproterenol Hydrochloride)
Kenalog (see Triamcinolone Acetonide)
Keppra intraveneous (see Levetiracetam)
October 2012
Per Pellet
50 mg
1 ml
2 mg
Invoice
$19.040
$8.060
$0.699
Invoice
$18.088
$7.657
$0.664
Increase
10 mg
$0.446
$0.424
Increase
0.1 mg
0.5 mg
5 mg
$2.005
$42.830
$2.179
$1.905
$40.689
$2.070
Increase
35 mg
500 mg
$1.048
$37.484
$0.996
$35.610
Increase
0.2 mg
$0.614
$0.583
Increase
100 units
6 gm
100 mg, per study
dose
$0.032
$23.040
$0.030
$21.888
$660.677
$627.643
IV
Increase
Increase
1000 mcg/ml
$1.212
$1.151
5 mg
$4.050
$3.848
New Code for 2012:
J0588
1 Unit
1 sq cm
$24.147
$22.940
1mg
Increase
0.2 mg
$2.250
- page 22 -
$2.138
Ketamine Hydrochloride (Ketalar) Allowed
when billed on same day as 20550-20610,
62289, 62298, 62368, 95990, or 96530.
10 mg
$0.067
$0.064
Added September
2012
Normodyne) Covered if given IV in the office
for control of BP in severe hypertension.
Patient is normally switched to oral for
maintainance doses.
** Levobupivacaine Hydrochloride
(Chirocaine) Allowed separately when billed
on same day as 51700, 51720, 62310, 62311,
62318, 62319, 62368, 64400 - 64484, 6450564530, 76003, 95990, or 96530. Not payable
separately when billed with any other
procedures
** Levophed Bitartrate (see Norepinephrine
Bitartrate)
** Levothyroxine Sodium (Synthroid) Need
statemnt on claim as to why patient can’t
take oral form of drug.
Lexiscan (see Regadenoson)
Lidocaine - Allowed separately when billed
on same day as 51700, 51720, 62310, 62311,
62318, 62319, 62368, 64400 - 64484, 64505 64530, 77033, 95990, or 96530. Not payable
when billed with any other procedure.
Lucentis (see Ranibizumab)
Lusedra (see Fospropofol Disodium injection)
Marqibo (see Vincristine sulfate Liposome)
5 mg
$0.240
$0.228
2.5 mg/ml
$0.310
$0.295
0.5 mg
$62.010
$58.910
1 ml
$0.143
$0.136
Added September
2012
Methylnaltrexone Bromide (Relistor) Noncovered by carrier.
Metoprolol Tartrate (Lopressor) Covered
when given IV with Dobutamine J1250
during Dobutamine Stress Test.
Metronidazole Hcl. (Flagyl IV) IV in the office.
Covered for ICD-9’s= 001.0-009.3, 040.0041.9, 481-482.9, 567.0-567.9, 599.0-599.9,
615.0-615.9.
Minocycline Hydrochloride (Non-covered
oral drug)
Morrhuate Sodium
Nafcillin Sodium (Nallpen) (Dosage Change
from 500 mg to 1 gm)
Netilmicin Sulfate (Netromycin), 150 mg
Nexium IV (see Esomeprazole Sodium)
Nitroglycerin IV – Allowed in emergency
situations.
Nodolo & Tusal (see Sodium Thiosalicylate)
Decrease
1 mg
$0.163
$0.155
Increase
500 mg
$1.069
$1.016
Increase
Invoice
Invoice
50 mg
$2.105
$2.000
1 gm
$8.058
$7.655
10 mcg
$0.276
Invoice
$0.262
Invoice
5 mg
$0.345
$0.328
- page 23 -
Increase
October 2012
** Norepinephrine Bitartrate (Levophed
Bitartrate) Allow in emergency situations.
Normodyne (see Labetalol Hydrochloride)
Olanzapine short-acting intramuscular
injection (Zyprexa IM) Covered indications
= 295.01 - 295.84 when administered in the
physicians office.
Optison
** Oxychlorosene Sodium (Clorpactin WCS90)
Ozurdex (see Dexamethasone Intravitreal
Implant)
Pantoprazole Sodium, IV (Protonix IV) Need
statement as to why patient is not able to
take oral form.
** Peginterferon Alfa-2A/Isopropyl Alchol
(Pegasys®) Covered indication 070.54 when
Peginterferon Alfa-2B (PEG-Intron) 50
mcg Covered indication 070.54 when
Pegloticase (Krystexxa) When billed with
J3490 or J3590, covered for chronic gout,
ICD-9’s 274.00 through 274.03
** Pegvisomant for Injection (Somavert)
Considered Usually Self-Administered
1 mg
$2.161
$2.053
50 ml
$1.430
$1.359
Invoice
Invoice
$1.705
$1.620
Invoice
Invoice
1 gm
$1.850
$1.758
40 mg
$4.511
$4.285
180mcg/ml
$480.273
$456.259
50 mcg
$320.610
$304.580
80 mcg
120 mcg
150 mcg
$336.600
$353.460
$371.120
$319.770
$335.787
$352.564
0.5 mg
1mg
Added September
2012
Pertuzumab (Perjeta) Covered ICD-9 174.0
- 175.9 in combination with Trastuzumab
J9355 and Docetaxel J9171
Potassium Acetate
Potassium Phosphate
Propofol (Diprivan)
Protonix IV (see Pantoprazole Sodium)
Relistor (see Methylnaltrexone Bromide)
Revex (see Nalmefene Hydrochloride)
Thiosalicylate)
RiaSTAP (see Fibrinogen Concentrate Human)
Rifampin
Increase
1mg/ml
$9.704
$9.219
2 meq
3 mmol
1%
2%
$0.027
$0.043
$2.360
$3.400
$0.026
$0.041
$2.242
$3.230
10 mg
$0.103
$0.098
600 mg
$32.776
$31.137
Added September
2012
Increase
July 2013
- page 24 -
Sarracenia Purpura Non-covered by Carrier
Sensorcaine, Sterile (see Bupivicaine, Sterile)
Sodium Acetate
** Sodium Tetradecyl Sulfate (Sotradecol)
** Sodium Thiosalicylate (Rexolate &
Arthrolate, Nodolo & Tusal)
Sodium Thiosulfate
** Somavert (see Pegvisomant for Injection)
** Sufentanil Citrate (Sufenta) Separate
payment allowed when billed with 62310,
62311, 62318, 62319, 76005, 95990, or 96530.
If billed with any other procedures, it will
be considered part of the procedure and
separate payment will not be allowed.
Sulfamethoxazole/Trimethoprim (SMZTMP) Documentation as to why the patient
needs to be on IV infusion instead of oral
medication, must be in block 19 or as
an attachment for paper claims or in the
notepad for EMC claims.
SurgiMend
Synthroid (see Levothyroxine Sodium)
Tagamet (see Cimetidine Hydrochloride)
Testosterone
Tetanus Toxoid (use codes 90702, 90703, or
90718)
Tetracycline
Trandate (see Labetalol Hydrochloride)
Treanda (see Bendamustine Hydrochloride)
Vaccinia IVIG (see Human Immune Globulin
Intravenous)
Valproate Sodium (Depacon) IV, Covered
ICD9’s = 345.00 - 345.91, Allowed when
administered IV, in the physician’s office.
(Dosage change from 500 mg to 100 mg)
Vasopressin
Per infusion
(minimum 50
million cells)
2 meq
7.5%/50 ml
50 ml
250 cc
New Code for 2012:
Q2043
Decrease
$0.031
$2.730
$0.122
$0.708
Invoice
$0.029
$2.594
$0.116
$0.673
Invoice
50 mg
$0.970
$0.922
100 mg
$0.155
$0.147
5 cc
$0.052
$0.049
1000 ml
50mcg/ml
$5.640
$9.810
$5.358
$9.320
400 - 80 mg
$0.276
$0.262
Increase
0.5 sq cm
$12.026
$11.425
Increase
37.5 mg
Per Pellet
$0.110
Invoice
$0.105
Invoice
Invoice
Invoice
100 mg
$0.558
$0.530
20 units
$2.310
$2.195
Increase
Increase
- page 25 -
July 2013
Vincristine Sulfate Liposome (Marquibo)
covered ICD-9: 204.00-204.02
** Vitamin B Complex (Follow B-12
guidelines)
** Vitamin C (see Ascorbic Acid) Non-covered
by Carrier
Subcutaneous)
VPRIV™ (see Velaglucerase alfa for injection)
Wilate (Human coagulation factor VIII (FVIII)
and von Willebrand factor (VWF) powder and
solvent for solution for injection) Covered
ICD-9: 286.4
Histolyticum)
Xyntha (see Antihemophilic Factor (Recomb)
Plasma/Albumin-Free)
1 mg
2.5 mg
$0.499
$3.167
2.25 mg.
Invoice
Up to 3 ml
$0.930
$0.474
$3.009
Added September
2012
$0.884
New Code for 2012:
J7183
1 IU VWF:RCO
Added September
2012
Added September
2012
Ziv-Aflibercept (Zaltrap) covered ICD-9 153.0
- 153.7 or 154.0 - 154.2
HOCM <= 149 MG/ML
HOCM >= 400 MG/ML
Decrease
100 mg.
$1,611.200
1 ml
1 ml
1 ml
1 ml
1 ml
1 ml
$0.041
$0.093
$0.100
$0.104
$0.107
$0.191
$0.039
$0.088
$0.095
$0.099
$0.102
$0.181
Amount in Controversy (AIC) Requirement for Administrative Law
Judge Hearings and Federal District Court Appeals
The Amount in Controversy (AIC) required to sustain Administrative Law Judge (ALJ) and Federal District Court
appeal rights has changed beginning January 1, 2013.
•
•
The amount that must remain in controversy for ALJ hearing requests filed on or before December 31, 2012,
is $130. This amount increases to $140 for ALJ hearing requests filed on or after January 1, 2013.
The amount that must remain in controversy for Federal District Court review requests filed on or before
December 31, 2012 is $1,350. This amount increases to $1,400 for appeals to Federal District Court filed on
or after January 1, 2013.
Please ensure that your staff is aware of these changes.
Background
The Medicare Prescription Drug, Improvement, and Modernization Act (MMA) requires an annual reevaluation
of the dollar amount in controversy required for an Administrative Law Judge (ALJ) hearing or Federal District
Court review. The amount in controversy increases by the percentage increase in the medical care component
of the consumer price index for all urban consumers (U.S. city average) for July 2003 to the July preceding the
year involved. Any amount that is not a multiple of $10 will be rounded to the nearest multiple of $10.
July 2013
- page 26 -
Reference:
o Third level of appeal (hearing by an ALJ)
o 2013 Amount in Controversy requirements for ALJ hearing requests: September 28, 2012 Federal
Register
o Fifth level of appeal (judicial review in Federal District Court)
o Code of Federal Regulations (42 CFR 405.1006): amount in controversy requirements
Balloon Sinusplasty (Local Coverage Article A51633): Retired
Effective May 13, 2013, the local coverage article “Balloon Sinusplasty in the Physician Office” (article A51633) is
retired. This article is no longer needed, as there is more current information available for this service.
Dates of Service: Is It ICD-9 or ICD-10?
This article was provided by the Centers for Medicare & Medicaid Services (CMS) and issued in the May 10, 2013,
ICD-10 Email Update. To sign-up to receive ICD-10 email update messages, go to: http://www.cms.gov/Medicare/
Coding/ICD10/CMS_ICD-10_Industry_Email_Updates.html
With the October 1, 2014, ICD-10 deadline approaching, you may be wondering how you will code a claim that
you are submitting in October 2014 for a service that your practice provided in September 2014.
Even if you submit your claim on or after the ICD-10 deadline, if the date of service was before the October 1,
2014, deadline, you will use ICD-9 to code the diagnosis.
For dates of service on or after the October 1, 2014, deadline, you will use ICD-10. You may not be able to use
ICD-9 and ICD-10 codes on the same claim based on your payers’ instructions. This may mean splitting services
that would typically be captured on one claim into two claims: one claim with ICD-9 diagnosis codes for
services provided before October 1, 2014, and another claim with ICD-10 diagnosis codes for services provided
on or after October 1, 2014.
Some trading partners may request that ICD-9 and ICD-10 codes be submitted on the same claim when dates
of service span the compliance date. Trading partner agreements will determine the need for split claims.
Here’s an example of a split claim:
A patient has an appointment on September 27, 2014, and is diagnosed with bronchitis. He returns for a followup appointment on October 3, 2014. In this case, a practice will submit a claim with an ICD-9 diagnosis code for
the first visit and another claim with an ICD-10 diagnosis code for the follow-up visit.
Make sure that your systems, third-party vendors, billing services, and clearinghouses can handle both ICD-9
and ICD-10 codes depending on the dates of service in the months following October 1, 2014.
Please note that future ICD-10 Email Updates will explore how Medicare will handle dates of service for
inpatient settings (e.g., a hospital inpatient stay that begins before the transition date and ends after the
transition date will be coded on a single claim with ICD-10). Stay tuned for details.
Keep Up to Date on ICD-10
Visit the CMS ICD-10 website for the latest news and resources and the ICD-10 continuing medical education
modules developed by CMS in partnership with Medscape to help you prepare for the October 1, 2014,
deadline.
- page 27 -
July 2013
Draft LCD Applications of Bioengineered Skin Substitutes: Ulcers (of
Lower Extremities) DL33173
Below are the comments CGS received concerning the draft Local Coverage Determination (LCD) Applications
of Bioengineered Skin Substitutes: Ulcers (of Lower Extremities) DL33173 and the actions taken.
Comment
Pg. 4 of 17 Bullet #4 Coverage will not be provided…. Q4124. Add code Q4131
Rationale: EpiFix is not a “biologic wound dressing”. The allograft is incorporated
into the wound bed through the healing process and is not removed; it provides
permanent wound closure.
Pg 4 of 17 Bullet #5: Consistent with FDA…. Q4124) to clean wounds…
Add: Q4131.
Pg 6 of 17 EpiFix® (Q4131) Indications:
• Neuropathic diabetic foot ulcer.
• Venous stasis ulcer.
• Partial or full thickness ulcers of greater than four weeks in duration, with
documented failure of prior treatment to heal the wound;
• Adequate circulation to support tissue growth; and
• Wounds free of infection, redness, drainage, underlying osteomyelitis,
surrounding cellulitis, tunnels and tracts, eschar, or any necrotic material present in
or surrounding the wound bed.
Pg 6 of 17 EpiFix (Q4131) Limitations:
• Treatment is limited to five applications per ulcer;
• Medicare does not cover retreatment of the same wound with EpiFix following an
unsuccessful course of treatment;
• Medicare does not cover retreatment of a successfully treated, healed ulcer.
Page 10 of 17
Group 3 Paragraph: NON-COVERED PRODUCTS
Group 3 Codes:
Delete:
Q4131 EPIFIX, PER SQUARE CENTIMETER
Page 10 of 17
Group 5 Paragraph: COVERED PRODUCTS
Group 5 Codes:
Add: Q4131 EPIFIX, PER SQUARE CENTIMETER.
Page 10 of 17
GROUP 7 PARAGRAPH: COVERED APPLICATION PROCEDURES: …
Add: & EpiFix
For the products designated by HCPCS codes….Q4124…
Add: and Q4131
Page 11 of 17
ICD-9 Codes that Support Medical Necessity
Group 1 Paragraph:
(2nd) Note: For the products covered by this LCD, use the appropriate ICD-9-CM
code(s) that applies to both the appropriate product (designated by Q4101, Q4102,
Q4106, Q4107, Q4110, Q4121, Q4124)
Add: Q4131
Page 11 of 17
(3rd) Note: Diagnosis criteria do not apply to the following CPT/HCPCS codes:
15002, 15003, 15004, and 15005, Q4100, Q4104, Q4105, Q4108, Q4111, Q4112,
Q4113, Q4114, Q4115, Q4116, Q4117, Q4118, Q4119, Q4120, Q4122, Q4123, Q4125,
Q4126, Q4127, Q4128, Q4129 Q4130, Q4131…
Delete: Q4131
Accept Request
No action taken at this time.
July 2013
- page 28 -
Page 13 of 17
Group 4 Paragraph: Group 3
For Q4101, Q4102, Q4106, …Q4124:
Add: and Q4131
Page 13 of 17
Group 5 Paragraph: Group 4A
For Q4101, Q4102, Q4106, Q4107, Q4110, Q4121 and Q4124:
Add: Q4131
Page 14 of 17
Group 6 Paragraph: Group 4B
For Q4101, Q4102, Q4106, Q4107, Q4110, Q4121 and Q4124:
Add: Q4131
Page 15 of 17
For Q4106, Q4107:
Add: Q4131
Page 15 of 17
Group 9 Paragraph: Group
6B
For Q4106, Q4107:
Add: Q4131
I recommend keeping the language that has been supported by medical evidence,
which is five applications per ulcer with no global period and removing the
language “though more than three applications of Apligraf to a single wound are
usually unnecessary”. In other words, the product should be used as studied and
approved by the FDA.
The language concerning
three applications was left
after consideration and
review of relevant material.
Not all wounds require 5
applications.
I was pleased when the Medicare policy changed to allow me to use Apligraf as
studied and prescribed-5 applications weekly over a 12 week period. We have to be
allowed to use products as they are labeled by the FDA so that we can get the best
outcomes clinically and financially. I implore you to keep the policy unchanged or
just simply follow the prescribing information in the package insert.
In the section regarding Limitations the following statements are present
- There should be no fewer than two weeks between applications for venous
stasis ulcers and there should be no fewer than three weeks between applications
for neuropathic diabetic foot ulcers. More frequent applications should be
documented in the patient’s medical records.
- For neuropathic diabetic foot ulcers, if after nine weeks of treatment, and three
applications of the skin substitute, satisfactory healing progress is not noted, then
re-application of the skin substitute is not recommended and other treatment
modalities must be considered
No action taken, 5
applications are allowed
but may not always be
necessary.
Does this statement apply to all products, or only ones without FDA indications.
Is there a change in coverage and number of applications able to be done
regarding products such as Apligraf (5 applications) or Dermagraft (8 applications)
which have an FDA indication for DFUs. Is there a mandated 3 week interval for
reapplication of the skin substitute?
The time limit on use of OASIS to 12 weeks. Some of the wounds we treat are very
large and deep, requiring an extended period of time for healing, with several
applications of OASIS. I would propose that if improvement is noted at 12 weeks,
the ongoing use of OASIS should be reimbursable.
After consideration the
language pertaining to 2
weeks between applications
for venous stasis ulcers was
removed.
The language for diabetic
foot ulcers was left since
changing the treatment
after no considerable
change should be
considered. This information
is based on FDA indications.
Number of applications
per product is based on
FDA indications for the
individual products.
No action taken this
policy pertains to lower
extremities and this would
be considered on a case by
case basis as indicated in
the limitation section.
- page 29 -
July 2013
The limitation of coverage to venous stasis ulcers and diabetic foot ulcers. As I
stated earlier, I often use this product on acute wounds that have failed to heal
with conservative treatment. In my field, I am often confronted with wounds as
a result of surgery or trauma that fail traditional measures, and require additional
intervention. This limitation would essentially make OASIS unavailable for many of
the complex, difficult wounds which I have treated successfully with OASIS.
There are some inconsistencies in the new guidelines. For example, some of the
skin substitute products are limited to a certain number of applications, while
others are limited by a number of weeks. In addition, only some of the products
have utilization limits. Those that do not carry those limitations (PriMatrix and
Theraskin) do not have any additional data behind them. If these changes are to
be made, I believe that it should be done consistently with important attention to
all data and current uses.
I am a vascular surgeon in Cleveland Ohio. My comments are in response to the
recent proposed reductions in coverage for Oasis Wound Matrix and Oasis Ultra
tri-layer. I have used the Oasis line of products for over six years while practicing
in a dedicated wound care setting first at The University of Pennsylvania and now
at The Cleveland Clinic. The Oasis line of products are valued as an effective and
cost efficient tool for the healing of patients who present with chronic non-healing
wounds in the tertiary care settings that I practice. Limiting the frequency of
application that is possible is likely to reduce the efficacy of the therapy. Lowering
the frequency to every other week seems problematic in that we are likely to
see an increased time to wound healing and associated costs to the system and
inconvenience and discomfort for the patients.
No action taken since this
policy only pertains to the
use of CTPs on the lower
extremities.
This was reviewed and
revised as needed in the
limitation and utilization
section.
Oasis limitation is twelve
per ulcer based on FDA
indications. This policy only
pertains to its use on the
lower extremities.
For my patients who often suffer from associated vascular occlusive disease,
aggressive and appropriate wound care in the ambulatory setting results in a
marked improvement in limb salvage rates for a challenging group of patients.
Patients who would otherwise have lost a limb secondary to a non-healing wound
and progressive infection. Moreover, as a surgeon, I have found the product to
be particularly helpful in allowing us to better heal many surgical site associated
wounds.
In summary, I believe that much more consideration and debate should be given to
reducing the coverage for this valuable product and we should continue to allow
the published literature to guide the products indications and reimbursement.
Please do not hesitate to contact me with any questions
I am writing this letter addressing the proposed changes in the LCD Draft DL33173.
I am a podiatrist that has been using Oasis for over 20 years. In my practice I have
used it on DFUs and VLUs, but also have used it on numerous post-operative
wounds on immune-compromised patients. My results have shown that when I use
Oasis on a weekly basis, the closure of the wound is significantly faster than on a bi/
tri weekly basis.
No action taken since this
policy only pertains to the
use of CTPs on the lower
extremities.
Compared to the other advanced wound care products, there is a significant cost
savings for the patient and Medicare. The ease of use and long shelf life, allows
me to have it available at any time, thus saving the patient a repeat visit for an
application of an advanced product. Also there is high level of evidence to show
that Oasis works. In Mostow et. Al, they compared Oasis to standard of care on VLUs
and noticed a statistical significance to show that Oasis works.
Please reconsider the proposed draft to keep Oasis coverage as it is now. There is
no question in my mind that these changes will have a detrimental effect on my
patients.
July 2013
- page 30 -
Apligraf and Dermagraft
I am in favor of CGS covering products that have clinical evidence supporting
their use. There are numerous articles showing the effectiveness of Apligraf and
Dermagraft as stated in the LCD.
No action needed.
All skin substitutes are not the same, and I do not think the other products should
be grouped into the same category as the science and level of evidence are
different.
Suggested Changes to the Utilization Guidelines for all products
I recommend that CGS should revise the Utilization Guidelines:
“I recommend that for Class III Medical Devices and PMA products, after the fourth
application the medical record will be reviewed to determine medical necessity” .
These products are well studied and reevaluation after first application can delay
necessary treatment.
If CGS decides to continue to Class II Medical Devices and Cadaver Skin Products:
“I recommend that for Class II Medical Devices and Cadaver Skin Products, after
the first application the medical record will be reviewed to determine medical
necessity”. This makes sense since these other products do not have FDA approval
and a protocol that is clinically validated.
This simple rule would be easy for physicians to follow, would not require an
interpretation of the number of application allowed by FDA labeling for each
product. Importantly, I believe, such a policy would be consistent with CGS’s
intention to establish reasonable limitations on the number of applications of skin
substitutes.
Suggested Changes to Apligraf Section
We recommend that CGS should revise the Apligraf section to:
•
•
•
•
Apligraf is indicated for use with standard therapeutic compression for
the treatment of non-infected partial and full-thickness skin ulcers due to
venous insufficiency of greater than 1 month duration and which have not
adequately responded to conventional ulcer therapy.
Apligraf is also indicated for use with standard diabetic foot ulcer care
for the treatment of full-thickness neuropathic diabetic foot ulcers of
greater than three weeks duration which have not adequately responded
to conventional ulcer therapy and which extend through the dermis but
without tendon, muscle, capsule or bone exposure
Per FDA-approved labeling, no time restriction between applications
Keep the language about 5 applications per ulcer and remove the
following language, “though more than three applications of Apligraf to a
single wound are usually unnecessary”.
After consideration no
action was taken since
documentation should
indicate all steps in the
application and evaluation
for CTP product as indicated
in the documentation
requirements. The
frequency for each CTP
used for venous stasis and
diabetic foot ulcers is based
on the FDA packaging
and listed in the limitation
section of the policy.
Was considered and some
changes were made in
the limitation section for
Apligraf.
- page 31 -
July 2013
1.
2.
The LCD states in the ‘Limitations of Coverage’ section “There should
be no fewer than two weeks between applications for venous stasis
ulcers and there should be no fewer than three weeks between
applications for neuropathic diabetic foot ulcers. More frequent
applications should be documented in the patient’s medical records.”
and “Treatment of any ulcer will typically last no more than twelve
weeks.” In the Dermagraft specific limitation section, it states
“Frequency is limited to eight applications
The LCD also states in the ‘Limitations of Coverage’ section “For
neuropathic diabetic foot ulcers, if after nine weeks of treatment,
and three applications of the skin substitute, satisfactory healing
progress is not noted, then re-application of the skin substitute is not
recommended and other treatment modalities must be considered.
The limitation section was
updates as needed for
clarity concerning this issue.
Questions for both 1 and 2 above:
Is Dermagraft allowed for up to 8 applications? Is it sufficient that the provider
document they are using Dermagraft according to the Dermagraft FDA Labeling
and Directions for Use, as it states “In clinical studies evaluating Dermagraft for
treatment of ulcers in diabetic patients, Dermagraft was applied weekly up to a
total of 8 applications over a 12-week period.” The language in the Limitations of
Coverage section does not appear to agree with the language in the Dermagraft
section.
I am concerned providers may be confused by the varied language in the two
different sections (General limitations and Dermagraft limitations).
In the Dermagraft specific limitations section of the LCD, it states: “Studies
have documented that, for Q4106, survival of the dermal substitute decreases
significantly when the 24 steps noted in the FDA labeling are not followed,
therefore the 24 steps must be followed and documented.”
Question: Does the provider need to document every step or is documentation
they followed the twenty-four steps sufficient?
Additionally, under the Dermagraft specific limitations, there is a statement that
reads “Medicare does not cover continued reapplication of Dermagraft for the
same ulcer if satisfactory and reasonable healing progress is not noted after 12
weeks of therapy.”
A documentation
requirement section was
added to the policy.
Question: Dermagraft is only FDA approved for up to 12 weeks of therapy, so would
this statement be needed? The language may be confusing to providers, since
Dermagraft is approved for 8 weekly applications over 12 weeks.
July 2013
- page 32 -
Request
Shire Regenerative Medicine appreciates CGS’ attempt to develop coverage
parameters that are consistent and apply to all Bioengineered Skin Substitutes
in the LCD. However the treatment protocols in the clinical trials for the
Bioengineered Skin Substitutes are markedly different. Dermagraft’s pivotal trial
that generated evidence for FDA approval, demonstrated a 64% improvement in
wound healing with a 12 week treatment period when patients received up to 8
applications of Dermagraft. This finding is stated in Dermagraft’s FDA labeling and
Directions for Use (page 15, section 13) as follows: “In clinical studies evaluating
Dermagraft for treatment of ulcers in diabetic patients, Dermagraft was applied
weekly up to a total of 8 applications over a 12 week period.”
Dermagraft limitation
section was updated in the
final version.
We request revision of the following statement:
The LCD states in the ‘Limitations of Coverage’ section “There should be no fewer
than two weeks between applications for venous stasis ulcers and there should
be no fewer than three weeks between applications for neuropathic diabetic foot
ulcers. More frequent applications should be documented in the patient’s medical
records.”
Please revise the paragraph above as follows:
There should be no fewer than two (2) weeks between applications for venous
stasis ulcers and there should be no fewer than three (3) weeks between
applications for neuropathic diabetic foot ulcers, except when more frequent
applications are either a part of the FDA product specific labeling instructions or
are clearly supported by medical record documentation of medically reasonable
and necessary indications.
Restricting the use of Oasis to Venous and Diabetic ulcers of the lower extremity
will heavily limit our ability to treat patients with a broad range of wounds,
including post-surgical wounds, pressure ulcers, post-traumatic wounds, etc.
Additionally, the proposed reduction in number of applications from 12-4
(including our ability to place a new Oasis every week) is not what has been shown
as efficacious in published data on the product.
The Medicare policy change allowed for the application of five Apligrafs over a
twelve week period. This allowed the provider the opportunity to use the product
as labeled by the FDA and to get the best outcome both clinically and financially.
The prescribing policy as described above needs to remain unchanged
I feel that changing the indications to include only lower extremity ulcers could
significantly lead to the detriment of many patients who may benefit.
The new policy only
pertains to the use of CTPs
for lower extremities.
The Apligraf limitation
section was reviewed and
slightly revised in the final
version.
The new policy does not
limit the use of these CTPs
for other wounds in an
area outside of the lower
extremities. This policy is
guidance and clarification
for the use of these
particular CTPs in the lower
extremities.
- page 33 -
July 2013
I am writing to you in order to discuss some proposed changes regarding the
billing/usage of skin substitutes, specifically the extracellular matrix manufacturer
OASIS. Over the past several years I have had the opportunity to work at a
facility and in a field that sees its fair share of hard-to-treat wounds. The wounds
I have seen treated with OASIS and other extracellular matrices have all types of
etiologies. Whether the wound is a diabetic ulcer, venous stasis ulcer, pressure
ulcer, previously infected wound, burn, or skin graft, I have seen OASIS work
wonders for all of them. Wounds that had previously gone unhealed for months
and at times spanning up to 18 months were then treated with OASIS. Many of
these same wounds were then able to heal in a matter of only 8 weeks after serial
applications.
I urge you to consider the long term ramifications of changing the current
guidelines for bioengineered skin substitutes, to consider not only the long term
cost benefit of these extracellular matrices, but the overwhelming number of
patients who would suffer for these changes as well.
My concerns in regards to the possible limitations or changes that might occur
in regards for Oasis Wound Matrix and Oasis Ultra Tri-Layer Matrix for wound care
treatment in our patients. We see significant complicated patients presenting
with difficult wounds that have failed multiple different treatments at their
institutions that come to our institution and the Oasis Wound Matrix products
have proven to be effective in these patients. I am very concerned if there are any
changes in regulations, that these regulations might limit the ability to use these
products. This wound matrix has been very effective in many different of wounds
and particularly effective in helping neuropathic diabetic foot ulcers and venous
insufficiency which has been challenging to many other products that are currently
available on the market.
I am concerned about the proposed changes to the current LCD for OASIS; I
have been applying OASIS for 6 years. I have used this product in many wounds
successfully to shorten the healing time for abdominal wounds, pressure ulcers,
burns and spider bites. I do not have another product that can be used on a wide
variety of wounds. Apligraf can only be applied to legs and feet. To set every 2
week applications, may limit the healing process; I would prefer to use OASIS based
on clinical judgment; like, how much of the product has been absorbed, rather
than to have guidelines that dictate “apply every other week for 12 weeks”. In some
cases, the OASIS has been absorbed after 1 week’s application and needs another
application at that time; in other cases, the caramelization has not been absorbed
and can wait for maybe 2 weeks. It should be written so that there is room for
clinical judgment based on the wound’s progress.
extremities.
extremities.
extremities.
July 2013
- page 34 -
1) To request non-coverage for Oasis Wound Matrix and Oasis Ultra Tri-layered
Matrix, GraftJacket, Theraskin and Primatrix.
2) We recommend that CGS only cover products that have been approved by
the FDA after conducting one or more clinical trials and whose design has been
reviewed and approved by the FDA in the biologics licensing or device premarket
review process.
indication and limitation
section was updated for
clarity but no products were
removed for non-coverage
as requested.
3) We recommend that for biologics and Class III Medical Devices that after the
fourth application the medical record will be reviewed to determine medical
necessity. We recommend that if Class II Medical Devices and HCT/P Allograft
Products, are not excluded from the policy then, after the first application the
medical record will be reviewed to determine medical necessity because these
products generally have very little clinical data to support their use and have not
undergone the rigorous FDA review required for biologics and Class III medical
devices.
4) We recommend that under the Apligraf section the coverage guidelines be in
accordance with our FDA-approved labeling:
a. full-thickness neuropathic diabetic foot ulcers of greater than three weeks
duration
b. non-infected partial full-thickness skin ulcers due to venous insufficiency
of greater than 1 month duration
c. 5 applications
d. No time restriction between applications
We recommend that CGS not cover TheraSkin, Oasis, GraftJacket or Primatrix
because of the lack of valid clinical evidence supporting their use for treating
chronic wounds.
We recommend that CGS only cover FDA approved products that were approved
based on the results of clinical trials for specific indications whose design and
results were reviewed by the FDA. This recommendation is consistent with
recommendation (1) above, in that the FDA pre-market review process is a
straightforward and objective way for CGS to determine and verify that a product
has valid scientific evidence for a specific indication.
Attached in the appendix is our analysis of the clinical data supporting three such
skin-substitute products (Oasis, GraftJacket and TheraSkin) - all of which CGS is
considering for coverage.
We recommend that CGS revise the Apligraf section to:
•
•
•
•
Cover Apligraf when used with standard therapeutic compression for the
treatment of non-infected partial and full-thickness skin ulcers due to
venous insufficiency of greater than 1 month duration and which have not
adequately responded to conventional ulcer therapy.
Cover Apligraf when used with standard diabetic foot ulcer care for the
treatment of full-thickness neuropathic diabetic foot ulcers of greater
than three weeks duration which have not adequately responded to
conventional ulcer therapy and which extend through the dermis but
without tendon, muscle, capsule or bone exposure
Delete any time restriction between applications so physicians can apply
Apligraf when it is clinically indicated
Remove the following language, “though more than three applications of
Apligraf to a single wound are usually unnecessary”. The pivotal clinical
studies submitted to FDA in support of Apligraf’s® approval in DFU and
VLU, allowed for wounds to be to treated with up to five applications of
Apligraf®
The indication and
limitation section for the
CTP policy was updated
after consideration for
clarity.
- page 35 -
July 2013
It is my understanding that Kentucky Medicare is proposing to limit the coverage
of Oasis to every other week application and only provide reimbursement for
diabetic foot ulcers and venous insufficiency ulcers. In the burn population, I have
witnessed the use of Oasis to facilitate healing and limit hypertrophic scarring.
More expedient healing leads to decreased hypertrophic scarring and this greatly
effects the patient’s cosmetic and functional outcomes. I frequently use Oasis in
this capacity with excellent results.
Burns are traumatic, life changing injuries that often lead to deformity and
functional limitations. In my clinical experience, the use of Oasis limits the risk
of deformity and functional impairments especially in the face and hands. I urge
Kentucky Medicare to reconsider the proposal and reimburse Oasis to continue to
be utilized as is it now in burn patients, pressure ulcers, and post-surgical sites.
A nonhealing wound is a complicated pathology, and requires multiple treatment
modalities to heal these wounds. Current literature indicates that wounds that
are not healed by at least 50% by week four to the environment, the chance for
infection and possible hospitalization increases.
Advanced therapies like skin substitutes allow for less invasive procedures with
good outcomes. Limiting the number of applications will decrease viability and
force delayed healing and potential for hospitalization from infection.
I believe that consideration should be made to keep current practices in place
when it pertains to number of applications of various skin substitutes.
Not all diabetic ulcers that will respond to these Skin Substitutes are neuropathic. I
would like to remove the word neuropathic.
Elimination of underlying cellulitis, osteomyelitis, or other infection. I would like to
add active treatment of osteomyelitis.
Not involving tendon, muscle-I would like to remove tendon and muscle from this
statement. The presence of tendon and muscle in most cases will respond to skin
substitutes.
Two weeks between applications-This statement should have a disclaimer to allow
more frequent application if indicated by the product FDA labeling. Also why is a
neuropathic diabetic ulcer at three weeks?
Does this mean retreatment of the same limb, same person, or the same ulcer –pg.
4
Medicare does not cover treatment of a successfully treated, healed ulcer. This
statement is confusing. What does this mean? Do they mean if the ulcer reoccurs it
will not be covered?
Neuropathic diabetic foot ulcer. - Again are they only going to cover Neuropathic
diabetic ulcers? Also, in the past Oasis was used for pressure ulcers, arterial ulcers
and non-healing surgical wounds. Why were these indications left out of the
policy?
Redness, drainage- Redness does not mean there is an infection present. This
should be removed. Also drainage does not indicate an infection and they should
make it significant drainage.
extremities.
The limitation and
indication section was
updated for clarity and FDA
indications were used for
the frequency and time
frame for the number of
applications. If more time
is needed, this would be
based on a case-by-case
basis.
This was taken into
consideration and changes
made in the final draft.
This was taken into
This was taken into
This was taken into
made in the final draft for
the limitation section.
After consideration this was
updated and clarified in the
indication and limitation
section.
The indication and
limitation sections were
reviewed and updated
for clarity. This policy only
pertains to the use for CTPs
for lower extremities for
venous stasis and diabetic
foot ulcers and not for other
types of wounds in other
areas.
July 2013
- page 36 -
Medicare is limiting Grafjacket to 1 application per ulcer and in the note below it
allows a maximum of 2 applications. This needs to be clarified.
I would like an explanation on what is an unsuccessful course?
The indication and
limitation section was
updated in the final version
after consideration.
Theraskin-Why only foot and toes? Can this be used on the ankle and leg also?
Please define an unsuccessful course.
Use of pressure-reducing footwear:- Can we add AFO after pressure-reducing
footwear?
Non-weight bearing may not be possible and should be changed to an off-loading
regiment.
Pg. 7 Redness should be removed as exclusion, because redness can be present
without infection.
I am requesting that CGS keep the current policy for Apligraf unchanged or clearly
state that I can follow Apligraf’s prescribing information that is in the package
insert.
The Term “Bioengineered Skin Substitute” is Clinically Inaccurate and Should be
Replaced with the More Inclusive Descriptor “Cellular and/or Tissue Based Products
for Wounds (CTPs)”.
The Coalition is concerned with CGS using the term “bioengineered skin
substitutes” since it is not a technically accurate term and does not describe the
technology that is either currently or will be in the marketplace. Instead, the
Coalition recommends that CGS adopt the term “Cellular and/or tissue based
products for wounds (CTPs)” which does accurately describe and is broad and
inclusive of both current and future technology.
The indication and
updated after consideration.
No action taken the use for
Apligraf for venous stasis
and diabetic foot ulcers
is outlined based on FDA
indications. The new policy
only pertains to these types
of wounds/ulcers for the
lower extremities.
term CTP replaced the
term bioengineered skin
substitute.
- page 37 -
July 2013
The current policy for CTPs was well written and was in a format that was easy
to follow and understand. We have often referred to your policy as one that set
the standard which others should follow when submitting comments to other
contractors. The Coalition would have preferred if CGS would have maintained
the previous policy and just made a couple of modifications to that policy (such
as changing the terminology used to describe these products and provide more
information regarding the coverage it will use for determining coverage) instead of
rewriting the policy.
That being said, the Coalition appreciates that CGS has attempted to provide
criteria it will use for determining coverage for any CTP so as to guide the wound
care community in its research and publication efforts. The draft policy states, “we
have determined to cover those which we are satisfied have achieved at least a
threshold minimum of literature supporting their efficacy”. However, the policy
does not indicate what the minimum threshold is and whether companies that
are seeking coverage will have to meet the same or greater threshold. While we
believe that there are areas that still need to be clarified in this policy, providing
information to the wound care community regarding the type of information CGS
is seeking in order for products to be considered for coverage is necessary. This
will allow for a more transparent process for manufacturers when submitting their
product for coverage.
The Coalition believes that evidence can be established for coverage not only
through RCTs but also through a combination of retrospective clinical studies
(relevant since the populations of patients that demonstrate a need for the
products in question would be eliminated in many and most RCTs), scientific
evidence and expert knowledge. This approach is consistent with the widely
accepted definition of evidence based medicine but also adopted by the newly
created important organization Patient Centered Outcomes Research Institute
(PCORI). We believe that payers should cover these CTPs if the manufacturers
provide clinical evidence in peer reviewed journals showing positive outcomes
of their products without regard of how they are regulated by the FDA—Class II,
III or HCT/Ps. There are examples of A/B MAC policies [NHIC] which have applied
this approach and have broader product coverage of CPT products, some with
additional indications for wounds with deeper tissue exposure of muscle, tendon
and bone, not provided by this draft coverage policy.
The Coalition would like to recommend that CGS not utilize the draft LCD format
but rather continue utilizing the current LCD format with the “general indications
and limitations to Medicare coverage and payment” applied “to all materials and
services related to skin substitute/replacement” with the more specific coverage
information pertaining to the individual CTPs included in the LCAs.
The title of the draft LCD - Application of Bioengineered Skin Substitutes: Ulcers
(Lower Extremities) is significantly different than CGS’s previous policy title—
“Biologic Products for Wound Treatment and Surgical Interventions.” Instead of
having a broad focus, it now has a narrow one of ulcers of the lower extremity.
The policy has gone from surgical procedures to ulcers of the lower extremity. This
policy is no longer inclusive of how and where these products are applied.
Language in the Policy: The Policy Title is “Application of Bioengineered Skin
Substitutes: Ulcers (of lower extremity).
Concerns: The Coalition is concerned that in this draft policy the coverage of CTPs
are limited to lower extremity wounds. This is a clear departure from the previous
LCD and therefore it is unclear whether other wound types will be covered by CGS.
Previously, CGS covered acute postoperative wounds, deep tissue reconstruction
and/or replacements or burns in this policy. We question whether they would still
be covered based on medical necessity. If not, the beneficiaries with these other
wounds will lose access to state-of-the-art technology.
The new policy is only for
guidance for the use of
CTPs for venous stasis and
diabetic foot ulcers for the
lower extremities and does
not pertain to any other use
of CTPs for other wounds in
a different area.
term CTP replaced the
term bioengineered skin
substitute. The new policy
is only for guidance for the
use of CTPs for venous stasis
and diabetic foot ulcers for
the lower extremities and
does not pertain to any
other use of CTPs for other
wounds in a different area.
July 2013
- page 38 -
The Coalition’s concerns are that the manner in which CGS describes the limitations
for use are not consistent for all of the CTPs—some are applications per ulcer
versus others are weeks of use. For instance, Apligraf describes applications per
ulcer; Oasis describes 12 weeks of therapy, while Primatrix does not provide any
specific limitations on the number of applications. This inconsistency will cause
confusion in the clinical community and needs to be uniform.
Furthermore, TheraSkin is currently covered by CGS under its existing LCD and
LCA for treatment of both DFUs and VLU’s, however; the draft LCD only includes
TheraSkin treatment for DFUs.
An additional issue within this section pertains to the language that retreatment of
a successfully healed ulcer is not covered nor is retreatment of an ulcer following
an unsuccessful course of treatment. This is hugely problematic as patients can down the road - develop another ulcer in the same location or can have further
breakdown OR can be placed on another type of product after an unsuccessful
course of treatment on one type of product.
The indication and
updated in the final version.
The indication and
The Coalition does not agree with the language as drafted in this policy as it is not
appropriate to eliminate coverage for a Medicare beneficiary if they have further
breakdown after a successful treatment of a wound or if a particular product was
tried unsuccessfully on a patient and the clinician determines that another product
may be used to help heal the wound. We therefore recommend that this language
be eliminated from the policy as it is not clinically sound.
- page 39 -
July 2013
The Coalition disagrees with the terminology that CGS has used in its draft
LCD, to state that coverage will not be provided for products that do not meet
the definition of HCPCS codes Q4101, Q4102, Q4106 Q4107, Q4110, Q4121 or
Q4124 and that all other products would be considered at most “biologic wound
dressings.” None of the CTPs included in this draft LCD are biologic wound
dressings. They all support wound healing by interacting directly or indirectly with
the body. There is much confusion about the use of these terms which raises the
point that FDA and CMS use different terminology to describe these CTPs and
cannot be used interchangeably.
It is inaccurate to describe these CTPs as “biologic wound dressings” since this
term is neither used by CMS or FDA to describe these biologic products. These are
not “biologic wound dressings” or “surgical dressings” in function or technology.
Those dressings are intended to cover a wound, protect from contamination, and
to manage the wound condition such as exudate, necrotic tissue or excess dryness.
They are not interactive in the wound bed and are identified by CMS in the surgical
dressing LCD as “A codes.” On the other hand, the CTPs in this LCD are identified by
CMS as “Q codes” - that interact with the body to support repair, and are not usually
removable.
Furthermore, a product’s eligibility for Medicare coverage purposes depends on (a)
whether a product is considered a “drug or biological” under Medicare law, and (b)
whether the product otherwise meets the requirements to be covered as a drug or
biological provided “incident to” a physician’s service.
Recommendation: CGS should not classify any of the products listed in this draft
LCD as “biologic wound dressings” as this description/terminology is simply
incorrect. If CGS is trying to limit the number of products that are covered under
this LCD then a better way of doing that is requiring studies to show a products
efficacy. Sample language to be added to the LCD could include, “The contractor
may determine a product use to be reasonable and necessary for the treatment of
wounds or other conditions if, on the basis of available or presented evidence, it
is shown to be safe and effective and does not violate national or local Medicare
determinations and regulations. The approval will be limited to specific indications
and/or patient populations, practitioner categories, procedures, and/or place of
service.”
Furthermore, the Coalition recommends, that consistent with Medicare law, if a
product has a USP monograph, and meets the requirements to be covered as a
biological provided “incident to” a physician’s service, the Coalition recommends
that those CTPs be covered under your policy. As such, we request that CGS rereview proposed non-covered items to determine whether they meet the Medicare
standard for Part B coverage. We believe that there are other products that in fact
do meet the coverage standard and are eligible for coverage under this LCD
The Alliance is concerned with CGS using the term “bioengineered skin substitutes”
since it is not a technically accurate term and does not describe the technology
that is either currently or will be in the marketplace. Instead, the Alliance
recommends that CGS adopt the term “Cellular and/or tissue based products for
wounds (CTPs)” which does accurately describe and is broad and inclusive of both
current and future technology.
“We have determined to cover those which we are satisfied have achieved at least
a threshold minimum of literature supporting their efficacy”. However, the policy
does not indicate what the minimum threshold is and whether companies that are
seeking coverage will have to meet the same or greater threshold.
The Alliance would like to recommend that CGS retain the format of its current LCD.
Specifically, the section “general indications and limitations to Medicare coverage
and payment” should be more general and applied “to all materials and services
related to skin substitute/replacement”. Then, as with the current LCD, the Alliance
recommends that the more specific coverage information pertaining to the
individual CTPs be included in the LCAs.
The indication and
updated in the final draft.
a different area.
July 2013
- page 40 -
The title of the draft LCD - Application of Bioengineered Skin Substitutes: Ulcers
(Lower Extremities) is significantly different than CGS’s previous policy title—
“Biologic Products for Wound Treatment and Surgical Interventions.” Instead of
having a broad focus, it now has a narrow one of ulcers of the lower extremity.
The policy has gone from surgical procedures to ulcers of the lower extremity. This
policy is no longer inclusive of how and where these products are applied.
The Alliance is concerned that in this draft policy the coverage of CTPs are limited
to lower extremity wounds. This is a clear departure from the previous LCD and
therefore it is unclear whether other wound types will be covered by CGS.
The Alliance’s concern specifically lies with the language in the note and specifically
that “these conditions have been successfully treated and resolved”. While some of
the listed conditions (edema, infection and remove necrotic tissue) can be treated
and resolved, the other conditions are ongoing treatments that support the
healing process.
Recommendations: The Alliance recommends that the language simply read, “For
purposes of this LCD, conservative measures include but are not limited to” and
that CGS eliminate the language in the notes which states “these conditions have
been successfully treated and resolved” prior to the LCD becoming final.
Only apply skin substitutes to wounds with adequate circulation/oxygenation
to support tissue growth/wound healing as evidenced by physical examination
(presence of acceptable peripheral pulses and or ankle brachial index (ABI) of no
less than 0.65).
Concerns: The Alliance maintains that the language which requests the “presence
of acceptable peripheral pulses” is not only vague, but there is no clinical evidence
which supports it. As such, the Alliance would like to request that CGS provide the
clinical findings which support the presence of acceptable peripheral pulse.
Recommendations: The Alliance recommends that CGS eliminate “presence of
acceptable peripheral pulses” from the draft LCD before it becomes final as it is
vague and there is no clinical evidence which supports it.
There should be no fewer than two weeks between applications for venous stasis
ulcers and there should be no fewer than three weeks between applications
documented in the patient’s medical records. Treatment of any ulcer will typically
last no more than twelve weeks.
a different area.
The indication and
The indication and
of the policy.
The indication and
of the policy.
The Alliance’s concerns are that the manner in which CGS describes the limitations
for use are not consistent for all of the CTPs—some are applications per ulcer
versus others are weeks of use. For instance, Apligraf describes applications per
ulcer; Oasis describes 12 weeks of therapy, while Primatrix does not provide any
specific limitations on the number of applications. This inconsistency will cause
confusion in the clinical community and needs to be uniform.
- page 41 -
July 2013
The Alliance recommends that CGS eliminate the language that states, “There
should be no fewer than two weeks between applications for venous stasis
ulcers and there should be no fewer than three weeks between applications
documented in the patient’s medical records” and “Treatment of any ulcer will
typically last no more than twelve weeks.” Furthermore, the Alliance recommends
that the language regarding the number of applications should read:
The number of applications per ulcer is based on the FDA labeling and clinical
evidence in published clinical trials for the product.
Finally, the Alliance recommends that prior to release of a final policy; CGS should
consider an indication correction for Theraskin along with clinical evidence from
the manufacturer to support DFU, VLU, and other indications as suggested in their
package label.
2. Issue: An additional issue within this section pertains to the language that
retreatment of a successfully healed ulcer is not covered nor is retreatment of an
ulcer following an unsuccessful course of treatment. This is hugely problematic as
patients can - down the road - develop another ulcer in the same location or can
have further breakdown OR can be placed on another type of product after an
unsuccessful course of treatment on one type of product.
Language in the Policy: Retreatment of an ulcer following an unsuccessful course
of treatment is not covered. Retreatment of a successfully treated healed ulcer is
not treated.
Recommendations: The Alliance does not agree with the language as drafted in
this policy as it is not appropriate to eliminate coverage for a Medicare beneficiary
if they have further breakdown after a successful treatment of a wound or if
a particular product was tried unsuccessfully on a patient and the clinician
determines that another product may be used to help heal the wound. We
therefore recommend that this language be eliminated from the policy as it is not
clinically sound.
The Alliance recommends that CGS include the ICD-9 codes provided below
prior to the LCD becoming final: 459.31 Chronic venous hypertension with ulcer
459.33 Chronic venous hypertension with ulcer and inflammation 459.81 Venous
insufficiency, NOS
I am requesting CGS keep the current LCD language for Apligraf unchanged or
clearly state that Apligraf can be utilized according the prescribing information that
is in the package insert.
Create consistency between the covered products and approved utilization
limitations
TheraSkin coverage in Draft LCD should include venous leg ulcers consistent with
currently effective LCD
Revise ICD-9 codes that support medical necessity in Draft LCD to avoid coding
confusion and create consistency with current CGS policy and other MACs
My supervising physician and I use Oasis on difficult wounds who have failed to
heal with other methods. Many of the patients we treat with Oasis and have good
results fall outside of the proposed indications.
Currently we are treating a man who has a history of merkel cell carcinoma who
underwent resection with several skin grafts and then went onto radiation and
chemotherapy. Since his radiation he has been battling with chronic open wounds.
Several wound care modalites were utilized without much improvement. We
started him on Oasis and were able to close a majority of his leg wounds making
a positive impact on the patient. This is just one example of patient scenarios we
frequently encounter. Please take this example into consideration when making
the proposed changes.
The indication and
of the policy.
The indication and
of the policy.
The indication and
of the policy.
a different area.
July 2013
- page 42 -
With the proposed changes in billing that limit coverage to venous stasis and
diabetic foot ulcers, these patients with post-surgical or trauma wounds would be
excluded from OASIS as a treatment option.
a different area.
Fecal Microbiota Transfer
CGS has received inquiries into the coverage of fecal microbiota transfer (FMT) for the treatment of Clostridium
difficile infection (CDI). After review of current literature, CGS has determined FMT to be a non-covered service
at this time as a statutorily excluded service. CGS will continue to monitor the literature on this procedure as it
becomes available.
Any other services performed that are related to the FMT procedure will also be denied as non-covered,
including but not limited to anoscopy and donor specimen.
Health care providers are not required to submit claims to Medicare for statutorily non-covered services;
however, you may choose to submit claims (e.g., at the patient’s request). Claims for FMT must include:
•
•
•
•
CPT code 44799
HCPCS modifier GY (statutorily non-covered service)
The appropriate ICD-9-CM code(s)
The name of the test, “FMT”
o Electronic Claims: Loop 2400, NTE02, or SV101-7 field
o Paper Claims: Block 19
Reference:
• Definition of “reasonable and medically necessary”: Social Security Act, section 1862(a)(1)(A)
• Exception to mandatory claim submission for “statutorily excluded services”: CMS MLN Matters article
SE0908, “Mandatory Claims Submission and Its Enforcement”
Local Carrier Payment Allowance Limits for Medicare Part B Drugs
Effective January 1, 2013 through March 31, 2013 Note 1: The complete ASP Payment Allowance Limits list can be accessed at the following link:
http://www.cms.gov/McrPartBDrugAvgSalesPrice/01a18_2011ASPFiles.asp#TopOfPage
Note 2: Payment allowance limits subject to the ASP methodology are based on 2Q12 ASP data.
Note 3: The absence or presence of a HCPCS code and the payment allowance limits in this table does not
indicate Medicare coverage of the drug.
Similarly, the inclusion of a payment allowance limit within a specific column does not indicate Medicare
coverage of the drug in that specific category. These determinations shall be made by the local Medicare
contractor processing the claim.
Note 4: ** - Carrier-priced
- page 43 -
July 2013
HCPCS Code
Short Description
90396**
90396**
varicella-zoster immune globulin
90661**
Flu vaccine, derived from cell cultures, subunit
90736**
Zostavax
J0135**
J0178
J0200**
J0270**
J0275**
J0364**
J0380**
J0390**
J0395**
Adalimumab, 20 MG
Aflibercept 1 mg
Alatrofloxacin mesylate
Alprostadil, 1.25 MCG
Alprostadil Urethral Suppository
Apomorphine / Hydrochloride
metaraminol bitartrate, inj
Chloroquine injection
Arbutamine HCl injection
J0520**
Bethanechol chloride inject
J0620**
J0630**
J0715**
J1060**
J1324**
J1438**
J1590**
J1595**
J1675**
J1680**
J1700**
J1710**
J1725**
J1830**
J1890**
J1960**
J1990**
J2170**
J2265**
J2278KD**
J2320**
J2354**
J2513**
J2650**
J2670**
J2940**
J2941**
J3030**
J3110**
J3140**
Calcium glycerophosphate/Calcium lactate
Calcitonin Salmon
Ceftizoxime sodium / 500 MG
Testosterone cypionate 1 ML
Enfuvirtide
Etanercept
Gatifloxacin injection
Injection glatiramer acetate
Histrelin Acetate
fibrinogen concentrate human
Hydrocortisone acetate inj
Hydrocortisone sodium ph inj
Hydroxyprogesterone Caporate
Interferon beta-1b / .25 MG
Cephalothin sodium injection
Levorphanol tartrate
Chlordiazepoxide injection
Mecasermin
Minocycline Hydrochloride
Ziconotide injection
Nandrolone decanoate 50 MG
Octreotide Acetate
Pentastarch 10% solution
Prednisolone acetate
Tolazoline hcl injection
Somatrem injection
Somatropin injection
Sumatriptan Succinate
Teriparatide injection
Testosterone suspension
HCPCS Code
Payment Limit
Dosage
125 U / 1.25 ML
Invoice
625 U / 6.25 ML
Invoice
Per Carrier Medical Director not
covered by Part B.
covered by Part B.
Considered self-administered.
1 MG
$980.50
100 MG
Invoice
10 MG
Invoice
250 MG
Invoice
1 MG
Invoice
Oral drug considered part of procedure
in physician’s office.
10 ML
Invoice
500 MG
Invoice
1 ML
Invoice
100 MG
$ 103.550
25 MG
$
0.360
50 MG
Invoice
1 MG
Invoice
Not covered by carrier.
1G
Invoice
2 MG
$
3.765
100 MG
Invoice
1 MCG
Invoice
50 MG
$
4.452
10%
Invoice
1 ML
$
0.342
25 MG
Invoice
50 MG
$
0.420
Notes
Added
January
2013
July 2013
- page 44 -
J3150**
J3265**
J3280**
J7130**
J7180**
J7191**
J7500**
J7502**
J7506**
J7507**
J7509**
J7510**
J7515**
J7517**
J7518**
J7520**
Testosterone propionate
Injection torsemide 10 mg/ml
Thiethylperazine maleate, inj
Hypertonic saline solution
Factor XIII
Factor viii (porcine)
Azathioprine oral 50 mg
Cyclosporine oral 100 mg
Prednisone oral
Tacrolimus oral per 1 MG
Methylprednisolone oral
Prednisolone oral per 5 mg
Mycophenolate mofetil oral
Mycophenolic acid
Sirolimus, oral
J7604**
Acetylcystein
J7605**
Arformoterol non-comp unit
J7606**
Formoterol fumarate, inh
J7608**
Acetylcystein non-comp unit
J7611**
Albuterol non-comp con
J7612**
Levalbuterol non-comp con
J7613**
Albuterol non-comp unit
J7614**
Levalbuterol non-comp unit
J7620**
Albuterol ipratrop non-comp
J7622**
Beclomethasone inhalation sol
J7624**
Betamethasone inhalation sol
J7626**
Budesonide non-comp unit
J7628**
Bitolterol mes inhal sol con
J7629**
Bitolterol mes inh sol u d
J7631**
Cromolyn sodium non-comp unit
J7633**
Budesonide concentrated sol
J7639**
Dornase alfa non-comp unit
J7641**
Flunisolide, inhalation sol
J7644**
Ipratropium bromide non-comp
J7648**
Isoetharine hcl inh sol con
J7649**
Isoetharine hcl inh sol u d
100 MG
$
0.798
10 MG
$
4.000
10 MG
Invoice
20 CC
Invoice
1 I.U.
Invoice
1 IU
Invoice
Should be billed to DMAC
Considered part of procedure in
- page 45 -
July 2013
J7658**
Isoproterenol hcl inh sol con
J7659**
Isoproterenol hcl inh sol ud
J7665**
Mannitol inh sol
J7668**
Metaproterenol inh sol con
J7669**
Metaproterenol non-comp unit
J7674**
Methacholine chloride, neb
J7680**
Terbutaline so4 inh sol con
J7681**
Terbutaline so4 inh sol u d
J7682**
Tobramycin non-comp unit
J7683**
Triamcinolone inh sol con
J7684**
Triamcinolone inh sol u d
J7686**
Treprostinil non-comp unit
J8501**
J8510**
J8520**
J8521**
J8530**
J8540**
J8560**
J8561**
J8562**
J8600**
J8610**
J8700**
J8705**
J9165**
J9213**
J9215**
J9218**
J9270**
J9600**
Q0163**
Q0164**
Q0165**
Q0166**
Q0167**
Q0168**
Q0169**
Q0170**
Q0174**
Q0179**
Q0180**
Oral aprepitant
Oral busulfan
Capecitabine, oral 150 mg
Cyclophosphamide oral 25 MG
Oral dexamethasone
Etoposide oral 50 MG
Everolimus, 0.25 MG
Oral fludarabine phosphate
Melphalan oral 2 MG
Methotrexate oral 2.5 MG
Temozolomide
Topotecan oral
Diethylstilbestrol diphosphate injection
Interferon alfa-2a inj
Interferon, alfa-n3
Leuprolide Acetate
Plicamycin (mithramycin) inj
Porfimer Sodium injection
Diphenhydramine HCI 50 mg
Prochlorperazine maleate 5 mg
Granisetron hcl 1 mg oral
Dronabinol 2.5 mg oral
Dronabinol 5 mg oral
Promethazine HCI 12.5 mg oral
Promethazine HCI 25 mg oral
Thiethylperazine maleate, 10mg
Ondansetron hcl 9 mg oral
Dolasetron mesylate oral
Unspecified oral dosage form, FDA approved
presription anti-emetic
Radiesse injection
Q0181**
Q2026**
Should be billed to DMAC.
250 MG
Invoice
3 MIL UNITS
Invoice
250,000 IU
$
23.834
2.5 MG
Invoice
75 MG
$ 3,004.740
0.1 ML
Invoice
July 2013
- page 46 -
Q2027**
Q2034**
Q2039**
Sculptra injection
Agriflu
Not Otherwise Classified flu vacc, 3 yrs & >, im
Q4074**
Iloprost non-comp unit dose
Q4118**
Q4119**
Q4122**
Q4124**
Q4125**
Q4126**
Q4127**
Q4128**
Q4129**
Q4130**
Q9955**
Matristem Micromatrix
Dermacell
Oasis Ultra Tri-Layer Wound Matrix
Arthroflex
Memoderm
Talymed
Flex HD or Allopatch HD
Unite Biomatrix
Strattice TM
Inj perflexane lip micros, ml
0.1 ML
Invoice
0.05 ML
Invoice
0.5 ML
$
12.375
1 MG
$
2.433
1 SQ CM
$
2.470
1 SQ CM
Invoice
1 SQ CM
$
11.400
1 SQ CM
Invoice
1 SQ CM
Invoice
1 SQ CM
Invoice
1 SQ CM
Invoice
1 SQ CM
Invoice
1 SQ CM
Invoice
1 ML
Invoice
Effective April 1, 2013 through June 30, 2013
Note 1: The complete ASP Payment Allowance Limits list can be accessed at the following link: http://www.cms.gov/McrPartBDrugAvgSalesPrice/01a18_2011ASPFiles.asp#TopOfPage
coverage of the drug in that specific category. These
determinations shall be made by the local Medicare contractor processing the claim.
Note 4: ** - Carrier-priced HCPCS
Code
Short Description
HCPCS Code Dosage
90396**
90396**
90661**
125 U / 1.25 ML
Invoice
625 U / 6.25 ML
Invoice
Per Carrier Medical Director not covered by
Part B.
90736**
Zostavax
Part B.
J0135**
J0178
J0200**
J0270**
J0275**
J0364**
J0380**
J0390**
J0395**
Adalimumab, 20 MG
Aflibercept 1 mg
1MG
$980.50
100 MG
Invoice
10 MG
Invoice
250 MG
Invoice
1 MG
Invoice
J0520**
Oral drug considered part of procedure in
J0620**
J0630**
Calcitonin Salmon
10 ML
Invoice
Payment Limit
Notes
Added
January
2013
- page 47 -
July 2013
J0715**
J1060**
J1324**
J1438**
J1590**
J1595**
J1675**
J1680**
J1700**
J1710**
J1725**
J1830**
J1890**
J1960**
J1990**
J2170**
J2265**
J2278KD**
J2320**
J2354**
J2513**
J2650**
J2670**
J2940**
J2941**
J3030**
J3110**
J3140**
J3150**
J3265**
J3280**
J7130**
J7180**
J7191**
J7500**
J7502**
J7506**
J7507**
J7509**
J7510**
J7515**
J7517**
J7518**
J7520**
Enfuvirtide
Etanercept
Histrelin Acetate
Mecasermin
Octreotide Acetate
Somatrem injection
Factor XIII
Prednisone oral
Mycophenolic acid
Sirolimus, oral
J7604**
Acetylcystein
J7605**
J7606**
J7608**
J7611**
500 MG
Invoice
1 ML
Invoice
100 MG
$ 103.550
25 MG
$
0.360
50 MG
Invoice
1 MG
Invoice
1G
Invoice
2 MG
$
3.765
100 MG
Invoice
1 MCG
Invoice
50 MG
$
4.452
10%
Invoice
1 ML
$
0.342
25 MG
Invoice
50 MG
$
0.420
100 MG
$
0.798
10 MG
$
4.000
10 MG
Invoice
20 CC
Invoice
1 I.U.
Invoice
1 IU
Invoice
Considered part of procedure in physician’s
office.
office.
office.
office.
office.
July 2013
- page 48 -
J7612**
J7613**
J7614**
J7620**
J7622**
J7624**
J7626**
J7628**
J7629**
J7631**
J7633**
J7639**
J7641**
J7644**
J7648**
J7649**
J7658**
J7659**
J7665**
Mannitol inh sol
J7668**
J7669**
J7674**
J7680**
J7681**
J7682**
J7683**
J7684**
J7686**
J8501**
J8510**
J8520**
J8521**
Oral aprepitant
Oral busulfan
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
- page 49 -
July 2013
J8530**
J8540**
J8560**
J8561**
J8562**
J8600**
J8610**
J8700**
J8705**
J9165**
J9213**
J9215**
J9218**
J9270**
J9600**
Q0163**
Q0164**
Q0165**
Q0166**
Q0167**
Q0168**
Q0169**
Q0170**
Q0174**
Q0179**
Q0180**
Q2026**
Q2027**
Q2034**
Q2039**
Oral dexamethasone
Everolimus, 0.25 MG
Melphalan oral 2 MG
Temozolomide
Topotecan oral
Interferon, alfa-n3
Leuprolide Acetate
Radiesse injection
Sculptra injection
Agriflu
Q4074**
Q4118**
Q4119**
Q4122**
Q4124**
Q4125**
Q4126**
Q4127**
Q4128**
Q4129**
Q4130**
Q9955**
Dermacell
Arthroflex
Memoderm
Talymed
Unite Biomatrix
Strattice TM
Q0181**
250 MG
Invoice
3 MIL UNITS
Invoice
250,000 IU
$
23.834
2.5 MG
Invoice
75 MG
$ 3,004.740
0.1 ML
Invoice
0.1 ML
Invoice
0.05 ML
Invoice
0.5 ML
$
12.375
office.
1 MG
$
2.433
1 SQ CM
$
2.470
1 SQ CM
Invoice
1 SQ CM
$
11.400
1 SQ CM
Invoice
1 SQ CM
Invoice
1 SQ CM
Invoice
1 SQ CM
Invoice
1 SQ CM
Invoice
1 SQ CM
Invoice
1 ML
Invoice
July 2013
- page 50 -
Effective July 1, 2012 through September 30, 2012 Revision: 4/1/2013
Note 1: The complete ASP Payment Allowance Limits list can be accessed at the following link:
coverage of the drug in that specific category. These determinations shall be made by the local Medicare
contractor processing the claim.
HCPCS
Code
Payment Limit
Dosage
125 U /
Invoice
1.25 ML
625 U /
Invoice
6.25 ML
covered by Part B.
HCPCS Code
Short Description
90396**
90396**
90661**
90736**
Zostavax
covered by Part B.
A9505
Thallium TI201
J0135**
J0200**
J0270**
J0275**
J0364**
J0380**
J0390**
J0395**
Adalimumab, 20 MG
100 MG
Invoice
10 MG
Invoice
250 MG
Invoice
1 MG
Invoice
J0520**
Oral drug considered part of procedure
in physician’s office.
J0620**
J0630**
J0715**
J1060**
J1324**
J1438**
J1590**
J1595**
J1675**
J1680**
J1700**
J1710**
J1725**
J1830**
Calcitonin Salmon
Enfuvirtide
Etanercept
Histrelin Acetate
10 ML
Invoice
500 MG
Invoice
1 ML
Invoice
100 MG
$ 103.550
25 MG
$
0.360
50 MG
Invoice
1 MG
Invoice
Invoice
Notes
Added
January
2013
added
March 2012
- page 51 -
July 2013
J1890**
J1960**
J1990**
J2170**
J2278KD**
J2320**
J2354**
J2513**
J2650**
J2670**
J2940**
J2941**
J3030**
J3110**
J3140**
J3150**
J3265**
J3280**
J7130**
J7191**
J7500**
J7502**
J7506**
J7507**
J7509**
J7510**
J7515**
J7517**
J7518**
J7520**
Mecasermin
Octreotide Acetate
Somatrem injection
Prednisone oral
Mycophenolic acid
Sirolimus, oral
J7604**
Acetylcystein
J7605**
J7606**
J7608**
J7611**
J7612**
J7613**
J7614**
J7620**
J7622**
J7624**
J7626**
J7628**
1G
Invoice
2 MG
$
3.765
100 MG
Invoice
1 MCG
Invoice
50 MG
$
4.452
10%
Invoice
1 ML
$
0.342
25 MG
Invoice
50 MG
$
0.420
100 MG
$
0.798
10 MG
$
4.000
10 MG
Invoice
20 CC
Invoice
1 IU
Invoice
July 2013
- page 52 -
J7629**
J7631**
J7633**
J7639**
J7641**
J7644**
J7648**
J7649**
J7658**
J7659**
J7668**
J7669**
J7674**
J7680**
J7681**
J7682**
J7683**
J7684**
J7686**
J8501**
J8510**
J8520**
J8521**
J8530**
J8540**
J8560**
J8562**
J8600**
J8610**
J8700**
J8705**
J9165**
Oral aprepitant
Oral busulfan
Oral dexamethasone
Melphalan oral 2 MG
Temozolomide
Topotecan oral
J9213**
J9215**
J9218**
J9270**
J9600**
Q0163**
Interferon, alfa-n3
Leuprolide Acetate
250 MG
Invoice
3 MIL
Invoice
UNITS
250,000 IU
$
23.834
2.5 MG
Invoice
75 MG
$ 3,004.740
- page 53 -
July 2013
Q0164**
Q0165**
Q0166**
Q0167**
Q0168**
Q0169**
Q0170**
Q0174**
Q0179**
Q0180**
Q2026**
Q2027**
Q2034**
Q2039**
Q2046
Radiesse injection
Sculptra injection
Agriflu
Aflibercept
Q4074**
Q4118**
Q4119**
Q4122**
Q4124**
Q4125**
Q4126**
Q4127**
Q4128**
Q4129**
Q4130**
Q9955**
Dermacell
Arthroflex
Memoderm
Talymed
Unite Biomatrix
Strattice TM
Q0181**
0.1 ML
Invoice
0.1 ML
Invoice
.05 ML
Invoice
0.5 ML
$
12.375
1 MG
$ 980.500
1 MG
$
2.433
1 SQ CM
$
2.470
1 SQ CM
Invoice
1 SQ CM
$
11.400
1 SQ CM
Invoice
1 SQ CM
Invoice
1 SQ CM
Invoice
1 SQ CM
Invoice
1 SQ CM
Invoice
1 SQ CM
Invoice
1 ML
Invoice
Effective October 1, 2012 through December 31, 2012
Note 1: The complete ASP Payment Allowance Limits list can be accessed at the following link:
coverage of the drug in that specific category. These
determinations shall be made by the local Medicare contractor processing the claim.
July 2013
- page 54 -
HCPCS Code
Short Description
HCPCS Code Dosage
Payment Limit
90396**
90396**
90661**
90736**
Zostavax
125 U / 1.25 ML
Invoice
625 U / 6.25 ML
Invoice
Part B.
Part B.
J0135**
J0200**
J0270**
J0275**
J0364**
J0380**
J0390**
J0395**
J0520**
Adalimumab, 20 MG
100 MG
Invoice
10 MG
Invoice
250 MG
Invoice
1 MG
Invoice
Oral drug considered part of procedure in
J0620**
J0630**
J0715**
J1060**
J1324**
J1438**
J1590**
J1595**
J1675**
J1680**
J1700**
J1710**
J1725**
J1830**
J1890**
J1960**
J1990**
J2170**
J2265**
J2278KD**
J2320**
J2354**
J2513**
J2650**
J2670**
J2940**
J2941**
J3030**
J3110**
J3140**
J3150**
J3265**
J3280**
J7130**
J7180**
J7191**
Calcitonin Salmon
Enfuvirtide
Etanercept
Histrelin Acetate
Mecasermin
Octreotide Acetate
Somatrem injection
Factor XIII
10 ML
Invoice
500 MG
Invoice
1 ML
Invoice
100 MG
$ 103.550
25 MG
$
0.360
50 MG
Invoice
1 MG
Invoice
1G
Invoice
2 MG
$
3.765
100 MG
Invoice
1 MCG
Invoice
50 MG
$
4.452
10%
Invoice
1 ML
$
0.342
25 MG
Invoice
50 MG
$
0.420
100 MG
$
0.798
10 MG
$
4.000
10 MG
Invoice
20 CC
Invoice
1 I.U.
Invoice
1 IU
Invoice
Notes
Added
January
2013
- page 55 -
July 2013
J7500**
J7502**
J7506**
J7507**
J7509**
J7510**
J7515**
J7517**
J7518**
J7520**
J7604**
Prednisone oral
Mycophenolic acid
Sirolimus, oral
Acetylcystein
J7605**
J7606**
J7608**
J7611**
J7612**
J7613**
J7614**
J7620**
J7622**
J7624**
J7626**
J7628**
J7629**
J7631**
J7633**
J7639**
J7641**
J7644**
J7648**
J7649**
J7658**
J7659**
J7665**
Mannitol inh sol
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
office.
July 2013
- page 56 -
J7668**
J7669**
J7674**
J7680**
J7681**
J7682**
J7683**
J7684**
J7686**
J8501**
J8510**
J8520**
J8521**
J8530**
J8540**
J8560**
J8561**
J8562**
J8600**
J8610**
J8700**
J8705**
J9165**
J9213**
J9215**
J9218**
J9270**
J9600**
Q0163**
Q0164**
Q0165**
Q0166**
Q0167**
Q0168**
Q0169**
Q0170**
Q0174**
Q0179**
Q0180**
Q0181**
Oral aprepitant
Oral busulfan
Oral dexamethasone
Everolimus, 0.25 MG
Melphalan oral 2 MG
Temozolomide
Topotecan oral
Interferon, alfa-n3
Leuprolide Acetate
Radiesse injection
Sculptra injection
Agriflu
Aflibercept
Q2026**
Q2027**
Q2034**
Q2039**
Q2046
office.
office.
office.
office.
office.
office.
office.
office.
office.
250 MG
Invoice
3 MIL UNITS
Invoice
250,000 IU
$
23.834
2.5 MG
Invoice
75 MG
$ 3,004.740
0.1 ML
0.1 ML
0.05 ML
0.5 ML
1 mg
Invoice
Invoice
Invoice
$
12.375
$ 980.500
- page 57 -
July 2013
Q4074**
Q4118**
Q4119**
Q4122**
Q4124**
Q4125**
Q4126**
Q4127**
Q4128**
Q4129**
Q4130**
Q9955**
Dermacell
Arthroflex
Memoderm
Talymed
Unite Biomatrix
Strattice TM
office.
1 MG
$
2.433
1 SQ CM
$
2.470
1 SQ CM
Invoice
1 SQ CM
$
11.400
1 SQ CM
Invoice
1 SQ CM
Invoice
1 SQ CM
Invoice
1 SQ CM
Invoice
1 SQ CM
Invoice
1 SQ CM
Invoice
1 ML
Invoice
MM8165 - Common Working File (CWF) Informational Unsolicited
Response (IUR) or Reject for a New Patient Visit Billed by the Same
Physician or Physician Group within the Past Three Years
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
News Flash –
REVISED products from the Medicare Learning Network® (MLN)
• “Medicare Remit Easy Print Software”, Fact Sheet, ICN 006740, downloadable
Note: This article was revised on June 4, 2013, to reflect the revised CR8165 issued on May 31. The article
shows a revised list of new patient CPT codes and an added list of established patient CPT codes on page
2. Also, the CR release date, transmittal number, and the Web address for accessing CR8165 have been
revised. All other information remains the same.
Provider Types Affected
This MLN Matters® Article is intended for physicians, other providers, and suppliers submitting claims to
Medicare contractors (carriers and A/B Medicare Administrative Contractors (A/B MACs)) for services to
Medicare beneficiaries.
Provider Action Needed
This article is based on Change Request (CR) 8165 which informs Medicare contractors about changes to
Medicare’s Common Working File (CWF) system that will detect erroneous billings when there are two new
patient Current Procedure Terminology (CPT) codes being billed within a three year period of time by the same
physician or physician group.
Make sure that your billing staffs are aware of these changes. See the Background and Additional Information
Sections of this article for further details regarding these changes.
Background
The Recovery Auditors, under contract with the Centers for Medicare & Medicaid Services (CMS), are responsible
for identifying and correcting improper payments in the Medicare Fee-For-Service payment process. The Recovery
Auditors have identified claims with “New Patient” Evaluation and Management (E&M) services to have improper
payments, because the new patient services have been billed two or more times within a 3-year period by the
same physician or physician group. The “Medicare Claims Processing Manual,” Chapter 12, Section 30.6.7 provides
that “Medicare interpret the phrase “new patient” to mean a patient who has not received any professional
services, i.e., E&M service or other face-to-face service (e.g., surgical procedure) from the physician or physician
group practice (same physician specialty) within the previous 3 years. For example, if a professional component of
a previous procedure is billed in a 3 year time period, e.g., a lab interpretation is billed and no E/M service or other
face-to-face service with the patient is performed, then this patient remains a new patient for the initial visit.”
July 2013
- page 58 -
As a result of overpayments for new patient E&M services that should have been paid as established patient
E&M services, CMS will implement changes to the CWF to prompt CMS contractors to validate that there are not
two new patient CPTs being paid within a three year period of time.
The new patient CPT codes that will be checked in these edits include 99201-99205, 99324-99328,
99341-99345, 99381-99387, 92002, and 92004. The edits will also check to ensure that a claim with one of
these new patient CPT codes is not paid subsequent to payment of a claim with an established patient CPT
code (99211-99215, 99334-99337, 99347-99350, 99391-99397, 92012, and 92014).
If Medicare discovers that a new patient code has been paid more than one time in a 3-year period to the
same physician, then Medicare contractors will consider this an overpayment and will take steps to recoup the
payment. If the situation is detected prior to payment of a second claim, the second claim will be rejected.
Additional Information
The official instruction, CR 8165 issued to your Medicare contractor regarding this change may be viewed at
http://www.cms.gov/Regulations-and- Guidance/Guidance/Transmittals/Downloads/R1244OTN.pdf on the
CMS website.
If you have any questions, please contact your Medicare contractor at their toll-free number, which may
be found at http://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/providercompliance-interactive-map/index.html on the CMS website.
MM8213 - Autologous Platelet-Rich Plasma (PRP) for Chronic NonHealing Wounds
News Flash CMS has instructed its contractors to delay turning on Phase 2 denial edits on the following claims to check for
a valid individual National Provider Identifier (NPI) and to deny the claim when this information is missing:
• Medicare Part B laboratory and imaging claims and Durable Medical Equipment, Orthotics, and
Supplies (DMEPOS) claims that require an ordering or referring physician/non-physician provider; and
• Part A Home Health Agency (HHA) claims that require an attending physician provider.
CMS will advise you of the new implementation date in the near future. In the interim, informational messages
will continue to be sent for those claims that would have been denied had the edits
been in place. See MLN Matters® Article SE1305 for more information.
Note: This article was revised on May 24, 2013, to add a descriptor for code G0460. The CR release date,
transmittal numbers and the Web address for accessing the CR were also revised. All other information
remains the same.
This MLN Matters® Article is intended for physicians and other providers submitting claims to Medicare
contractors (fiscal intermediaries (FIs), carriers, and A/B Medicare Administrative Contractors (MACs)) for
services to Medicare beneficiaries.
STOP – Impact to You
If you provide Medicare beneficiaries PRP for the treatment of chronic non-healing wounds, this
National Coverage Determination (NCD) could impact your reimbursement.
CAUTION – What You Need to Know
Effective for claims with dates of service on or after August 2, 2012, CMS will cover PRP for the treatment of
chronic non-healing diabetic, venous and/or pressure wounds only when provided under a clinical research
- page 59 -
July 2013
study that meets specific requirements to assess the health outcomes of PRP for the treatment of chronic nonhealing diabetic, venous and/or pressure wounds.
GO – What You Need to Do
Please refer to the Background section, below for details.
Background
PRP is produced by centrifuging a patient’s own blood to yield a concentrate that is high in both platelets and
plasma proteins; and includes whole white and red cells, fibrinogen, stem cells, macrophages, and fibroblasts.
Frequently administered as a spray, or a gel; physicians have used it in clinical or surgical settings, for a variety
of purposes such as an adhesive in plastic surgery and filler for acute wounds. In addition, it is being used, now,
on chronic, non-healing cutaneous wounds that persist for 30 days or longer.
Since 1992, the Centers for Medicare & Medicaid Services (CMS) has issued national non-coverage
determinations for platelet-derived wound healing formulas intended to treat patients with chronic, nonhealing wounds. In December 2003, CMS issued a national non-coverage determination specifically for the use
of autologous PRP in treating chronic non-healing cutaneous wounds except for routine costs when used in
accordance with the clinical trial policy defined in section 310.1 (Routine Costs in Clinical Trials (Effective July
9, 2007)) of the “National Coverage Determinations (NCD) Manual”. Currently, as of March 2008, CMS has noncoverage determinations for the use of
autologous blood-derived products for the treatment of acute wounds where PRP is applied directly to the
closed incision site, and for dehiscent wounds, as well as non-coverage for chronic, non-healing cutaneous
wounds.
On October 4, 2011, CMS accepted a formal request to reopen and revise Section 270.3 of the “Medicare NCD
Manual”, which addresses Autologous Blood-Derived Products for Chronic Non- Healing Wounds. The request
was for a reconsideration of the coverage of autologous PRP for the treatment of the following chronic wounds:
diabetic, venous, and/or pressure ulcers. It was requested that CMS cover PRP through an NCD with data
collection as a condition of coverage; and requested that this would provide a practical means by which CMS
could obtain the necessary data to evaluate the performance of PRP and to confirm the outcomes presented in
their request.
Effective August 2, 2012, upon reconsideration, CMS determined that PRP is covered for the treatment of
chronic non-healing diabetic, venous and/or pressure wounds only when the following conditions are met:
1. The patient is enrolled in a randomized clinical trial that addresses the questions listed below using
validated and reliable methods of evaluation. Clinical study applications for coverage pursuant to
this National Coverage Determination (NCD) must be approved by August 2, 2014. Any clinical study
approved by August 2, 2014, will adhere to the timeframe designated in the approved clinical study
protocol.
If there are no approved clinical studies on or before August 2, 2014, CED for PRP only for the treatment
of chronic non-healing diabetic, venous and/or pressure wounds will expire.
2. The clinical research study must meet the requirements specified below to assess PRP’s effect on the
treatment of chronic non-healing diabetic, venous and/or pressure wounds.
The clinical study must address:
• Prospectively, do Medicare beneficiaries, with chronic non-healing diabetic, venous and/or
pressure wounds, who receive well-defined optimal usual care along with PRP therapy, experience
clinically significant health outcomes compared to patients who receive only well- defined optimal
usual care for such wounds; as indicated by addressing at least one of the following:
• Complete wound healing?
• Ability to return to previous function and resumption of normal activities?
• Reduction of wound size or healing trajectory which results in the patient’s ability to return to
previous function and resumption of normal activities?
July 2013
- page 60 -
3. The required PRP clinical trial must adhere to the following standards of scientific integrity and
relevance to the Medicare population:
•
•
•
Its principal purpose is to test whether PRP improves the participants’ health outcomes;
It is well supported by available scientific and medical information or it is intended to clarify or
establish the health outcomes of interventions already in common clinical use;
• It does not unjustifiably duplicate existing studies;
• Its design is appropriate to answer the research question being asked in the study;
• It is sponsored by an organization or individual capable of executing the proposed study
successfully;
• It is in compliance with all applicable Federal regulations concerning the protection of human
subjects found at 45 CFR Part 46;
• All of its aspects are conducted according to appropriate standards of scientific integrity set by the
International Committee of Medical Journal Editors (http://www.icmje.org);
• It has a written protocol that clearly addresses, or incorporates by reference, the standards listed
here as Medicare requirements for coverage with evidence development (CED);
• It is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals.
Trials of all medical technologies measuring therapeutic outcomes as one of the objectives meet
this standard only if the disease or condition being studied is life threatening as defined in 21 CFR
§312.81(a) and the patient has no other viable treatment options;
•
•
It is registered on the ClinicalTrials.gov website (http://www.clinicaltrials.gov/) by the principal
sponsor/investigator prior to the enrollment of the first study subject;
Its study protocol:
a. Specifies the method and timing of public release of all pre-specified outcomes to be
measured, including the release of outcomes that are negative or that the study is terminated
early;
The results must be made public within 24 months of the end of data collection. If a report is
planned to be published in a peer reviewed journal, then that initial release may be an abstract
that meets the requirements of the International Committee of Medical Journal Editors (http://
www.icmje.org). However a full report of the outcomes must be made public no later than
three (3) years after the end of data collection;
b. Must explicitly discuss: 1) Subpopulations affected by the treatment under investigation,
particularly traditionally underrepresented groups in clinical studies; 2) How the inclusion and
exclusion criteria effect enrollment of these populations, and 3) A plan for the retention and
reporting of said populations on the trial.
If the inclusion and exclusion criteria are expected to have a negative effect on the recruitment
or retention of underrepresented populations, the protocol must discuss why these criteria are
necessary.
c. Explicitly discusses how the results are, or are not, expected to be generalizable to the
Medicare population to infer whether Medicare patients may benefit from the intervention.
Separate discussions in the protocol may be necessary for populations eligible for Medicare
due to age, disability or Medicaid eligibility.
Note: Consistent with Section 1142 of the Social Security Act (the Act), the Agency for Healthcare Research and
Quality (AHRQ) supports clinical research studies that CMS determines meet the above-listed standards and
address the above-listed research questions.
Coding and Payment Details
Healthcare Common Procedure Coding System (HCPCS) Codes
Effective for claims with dates of service on or after August 2, 2012, contractors will accept and pay PRP claims,
HCPCS code G0460 (Autologous PRP for ulcers), for the treatment of chronic non-healing diabetic, venous and/
or pressure wounds only in the context of an approved clinical study, when all of the following are present:
- page 61 -
July 2013
•
•
•
•
•
ICD-9/ICD-10 CM Diagnosis code from the list of diagnosis codes to be maintained by the contractors
Diagnosis code V70.7 (secondary dx) (ICD-10 Z00.6)
Condition code 30 (institutional claims only)
Clinical trial modifier Q0 (Investigational clinical service provided in a clinical research study that is in an
approved research study)
Value Code D4 with an 8-digit clinical trial number (optional, institutional claims only)
Medicare contractors will return to provider/return as unprocessable your PRP claims that do not include
ALL these diagnosis coding and additional billing requirements:
Should they return your PRP claims for the treatment of chronic non-healing diabetic, venous and/or pressure
wounds only in the context of an approved clinical study, they will use the following messages:
• CARC 16 - “Claim/service lacks information which is needed for adjudication.”
• RARC M16 - “Alert: See our Web site, mailings, or bulletins for more details concerning this policy/
procedure/decision.” and
• RARC MA130 – “Your claim contains incomplete and/or invalid information, and no appeal rights are
afforded because the claim is unprocessable. Please submit a new claim with the complete/correct
information.”
Type of Bill
Your contractor will pay claims for PRP services in the following settings:
•
•
•
•
•
•
•
Hospital outpatient departments Type of Bills (TOB) 12X and 13X based on OPPS;
Skilled Nursing Facilities (SNF) TOBs 22X and 23X based on MPFS;
Rural Health Clinics (RHC) TOB 71X based on all inclusive;
Comprehensive Outpatient Rehabilitation Facilities (CORF) TOB 75X based on MPFS;
Federally Qualified Health Centers (FQHC) TOB 77X based on all-inclusive,
Critical Access Hospitals (CAH) TOB 85X based on reasonable cost, and
CAHs TOB 85X and revenue codes 096X, 097X, or 098X based on MPFS.
They will pay for PRP services in Maryland hospitals under the jurisdiction of the Health Services Cost Review
Commission (HSCRC) on an outpatient basis, TOB 13X, in accordance with the terms of the Maryland waiver.
Contractors will deny claims for PRP services (HCPCS code G0460) when provided on other than TOBs 12X, 13X,
22X, 23X, 71X, 75X, 77X, and 85X using:
• CARC 58 – “Treatment was deemed by the payer to have been rendered in an inappropriate or invalid place
of service. NOTE: Refer to the 832 Healthcare Policy Identification Segment (loop 2110 Service payment
Information REF), if present”;
• RARC N428 – “Service/procedure not covered when performed in this place of service”; and
• Group Code: CO
Place of Service (POS) Professional Claims
Effective for claims with dates of service on or after August 2, 2012, you should use place of service (POS) codes
11 (Office), 22 (Outpatient Hospital), and 49 (Independent Clinic) for PRP services. Your contractor will deny all
other POS codes using the following messages:
• CARC 58 – “Treatment was deemed by the payer to have been rendered in an inappropriate or invalid place
of service”;
• RARC N428 – “Service/procedure not covered when performed in this place of service”; and
• Group Code: CO.
Note: Contractors will not retroactively adjust claims from August 2, 2012, through the implementation
of this CR. However, contractors may adjust claims that are brought to their attention.
CR 8213 is being released in two transmittals which may be found at:
• http://www.cms.gov/Regulations-and- Guidance/Guidance/Transmittals/Downloads/R153NCD.pdf and
• http://www.cms.gov/Regulations-and- Guidance/Guidance/Transmittals/Downloads/R2710CP.pdf on the
CMS website.
July 2013
- page 62 -
Both transmittals (R152NCD and R2666CP) contain a listing of relevant ICD-9 and ICD-10 diagnostic codes.
You can find information regarding clinical trials in the Claims Processing Manual, Chapter 32, Section
69 (Qualifying Clinical Trails), for information regarding clinical trials, at http://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/Downloads/clm104c32.pdf on the CMS website.
If you have any questions, please contact your FI, carrier or A/B MAC at their toll-free number, which may
be found at http://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring- Programs/providercompliance-interactive-map/index.html on the CMS website.
Flu Activity Continues: Prompt Antiviral Treatment is Crucial for Seniors Sick with Flu
This season, flu activity started early and has placed a significant burden on people 65 years of age and older.
In fact, so far this season, CDC has reported nearly four times more hospitalizations among people 65 and older
than occurred during the entire 2011-2012 season. The CDC recommends that vaccination efforts continue as
long as influenza viruses are circulating. People 65 years of age and older, as well as their close contacts and
caregivers, should be vaccinated; and should seek medical treatment with antiviral drugs as soon as symptoms
appear in order to reduce serious complications from flu infection, including hospitalizations, intensive care
unit (ICU) admissions and deaths.
Note: Influenza vaccine and its administration is a Medicare Part B covered benefit. Influenza vaccines are NOT
Part D-covered drugs.
For More Information:
• 2012-2013 Seasonal Influenza Vaccines Pricing list.
• MLN Matters® Article #MM8047, “Influenza Vaccine Payment Allowances - Annual Update for
• 2012-2013 Season”.
• Visit the CMS Medicare Learning Network® 2012-2013 Seasonal Influenza Virus Educational Products
and Resources and CMS Immunizations web pages for information on coverage and billing of the flu
vaccines and their administration fees.
• HealthMap Vaccine Finder is a free, online service where users can find locations offering flu vaccines as
well as other vaccines for adults.
• CDC website offers a variety of provider resources for the 2012-2013 flu season.
• CDC article Seniors among Seniors among Groups Hardest Hit by Flu this Season
MM8219 - Use of a Rubber Stamp for Signature
News Flash –
CMS is accepting Notices of Intent to Apply for the Medicare Shared Savings Program, Program Start Date
January 1, 2014 – NOI Due by May 31. If you are interested in applying for participation for the January 1, 2014
program start date of the Medicare Shared Savings Program, please submit a Notice of Intent to Apply (NOI) by
May 31, 2013. For more information, visit the Shared Savings Program Application web page. To learn more
about the application process, register to attend upcoming National Provider Calls on June 20 and July 18.
This MLN Matters® Article is intended for all physicians, providers, and suppliers submitting claims to Medicare
contractors (carriers, Fiscal Intermediaries (FIs), Regional Home Health Intermediaries (RHHIs) and A/B Medicare
Administrative Contractors (MACs) and Durable Medical Equipment (DME) MACs) for services provided to
What You Need to Know
For medical review purposes, the Centers for Medicare & Medicaid Services (CMS) requires that services
ordered/provided be authenticated by a handwritten or electronic signature. With few exceptions, stamped
signatures are not acceptable as described in Chapter/Section 3.3.2.4 of the “Medicare Program Integrity
- page 63 -
July 2013
Manual.” Change Request (CR) 8219 adds another exception to that manual. Under the added exception, CMS
will permit the use of a rubber stamp for signature in accordance with the Rehabilitation Act of 1973 in the case
of an author with a physical disability that can provide proof to a CMS contractor of his/her inability to sign their
signature due to their disability. By affixing the rubber stamp, the provider is certifying that they have reviewed
the document.
The official instruction, CR8219 issued to your Medicare contractor regarding this change may be viewed at
http://www.cms.hhs.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R465PI.pdf on the CMS
website.
MM8223 - Phase III Electronic Remittance Advice (ERA) Enrollment
Operating Rules
News Flash – Looking for the latest new and revised MLN Matters® articles? Subscribe to the MLN Matters®
electronic mailing list! For more information about MLN Matters® and how to register for this service, go to
http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network- MLN/MLNProducts/downloads/
What_Is_MLNMatters.pdf and start receiving updates immediately!
Note: This article was revised on May 10, 2013, to reflect a revised CR8223 issued on May 10. In the
article, the CR release date, transmittal number, and the Internet address for accessing the CR were
revised. All other information remains the same.
This MLN Matters® Article is intended for physicians, providers and suppliers enrolling for Electronic
Remittance Advice (ERA) with Medicare contractors (Fiscal Intermediaries (FIs), carriers, Regional Home Health
Intermediaries (RHHI), A/B Medicare Administrative Contractors (MACs) and Durable Medical Equipment (DME
MACs)).
STOP – Impact to You
This article is based on Change Request (CR) 8223, which instructs Medicare contractors on the steps they must
take to come into compliance with Phase III ERA Enrollment Operating Rule requirements by October 1, 2013.
Contractors must have paper-based ERA enrollment forms in compliance with Attachment 1 of CR 8223 no later
than July 1, 2014.
CAUTION – What You Need to Know
Medicare contractors must update their Electronic Remittance Advice (ERA) Enrollment forms for new
enrollments to comply with Attachment 1 of CR 8223. The contractors must comply with the following
requirements:
1. Identify a maximum set of standard data elements to be requested from providers for enrollment to receive
Electronic Remittance Advice (ERA).
2. Apply “controlled vocabulary” – predefined and authorized terms- for use when referring to the same data
element.
3. Use standard data elements to appear on paper enrollment form in a standard format and flow, using
consistent data elements and vocabulary as on the electronic form.
4. Use specific information or instruction to providers to assist in manual paper-based ERA enrollment.
5. Offer electronic ERA enrollment.
July 2013
- page 64 -
GO – What You Need to Do
Make sure that your billing staffs are aware of these updates to the ERA Enrollment Operating Rules.
Background
Section 1104 of the Affordable Care Act requires the Secretary of Health and Human Services to adopt and
regularly update standards, implementation specifications, and operating rules for the electronic exchange and
use of health information for the purpose of financial and administrative transaction.
What You Need to Know about the ERA Enrollment Form
Providers who have a signed ERA Enrollment Form on file with a particular Medicare contractor or Common
Electronic Data Interchange (CEDI) are not required to submit a new signed ERA Enrollment Form to the same
Medicare contractor or CEDI each time they change their method of electronic
billing or begin to use another type of electronic data interchange (EDI) transaction, e.g., changing from direct
submission to submission through a clearinghouse or changing from one billing agent to another.
Additionally, providers are not required to notify their Medicare contractor or CEDI if their existing
clearinghouse begins to use alternate software; the clearinghouse is responsible for notification in that
instance.
Medicare contractors and CEDIs must inform providers that providers are obligated to notify them in writing in
advance of a change that involves a change in the billing agent(s) or clearinghouse(s) used by the provider, the
effective date on which the provider will discontinue using a specific billing agent and/or clearinghouse, if the
provider wants to begin to use additional types of EDI transactions, or of other changes that might impact their
use of ERA.
When a Medicare contractor or CEDI receives a signed request from a provider or supplier to accept ERA
transactions from or send ERA transactions to a third party, the Medicare contractor or CEDI must verify that an
ERA Enrollment Form is already on file for that provider or supplier. The request cannot be processed until both
are submitted and issued.
The binding information in an ERA Enrollment Form does not expire if the person who signed that form for a
provider is no longer employed by the provider, or that Medicare contractor or CEDI is no longer associated
with the Medicare program. Medicare responsibility for ERA oversight and administration is simply transferred
in that case to that entity that the Centers for Medicare & Medicaid Services (CMS) chooses to replace that
Medicare contractor or CEDI, and the provider as an entity retains responsibility for those requirements
mentioned in the form regardless of any change in personnel on staff.
Contractors may require a wet signature to be submitted in conjunction with the electronic enrollment. (Note:
A wet signature is an original signature on a document that is then scanned and sent by e- mail.)
The document will become effective when signed by the provider. The responsibilities and obligations
contained in this document will remain in effect as long as Medicare claims are submitted to the Medicare
contractor, CEDI, or other contractor if designated by CMS. Either party may terminate the arrangement by
giving the other party thirty (30) days written notice of its intent to terminate. In the event that the notice is
mailed, the written notice of termination shall be deemed to have been given upon the date of mailing, as
established by the postmark or other appropriate evidence of transmittal.
The official instruction, CR 8223, issued to your FI, carrier and A/B MAC regarding this change may be viewed
at http://www.cms.gov/Regulations-and- Guidance/Guidance/Transmittals/Downloads/R1235OTN.pdf on the
CMS website.
If you have any questions, please contact your FI, carrier or A/B MAC at their toll-free number, which may
- page 65 -
July 2013
MM8255 - National Coverage Determination (NCD) for Transcatheter
Aortic Valve Replacement (TAVR) - Implementation of Mandatory
Reporting of Clinical Trial Number
News Flash – CMS is accepting Notices of Intent to Apply for the Medicare Shared Savings Program, Program
Start Date January 1, 2014 – NOI Due by May 31. If you are interested in applying for participation for the
January 1, 2014 program start date of the Medicare Shared Savings Program, please submit a Notice of Intent to
Apply (NOI) by May 31, 2013. For more information, visit the Shared Savings Program Application web page.
To learn more about the application process, register to attend upcoming National Provider Calls on June 20
and July 18.
This MLN Matters® Article is intended for physicians, other providers, and suppliers who submit claims to
Medicare contractors (Fiscal Intermediaries (FIs), carriers, and A/B Medicare Administrative Contractors (A/B
MACs)) for Transcatheter Aortic Valve Replacement (TAVR) services provided to Medicare beneficiaries.
Change Request (CR) 8255 is being issued to require that claims for TAVR carry an approved clinical trial
number, effective for claims processed on or after July 1, 2013. Given that TAVR is covered only under Coverage
with Evidence Development (CED), the Centers for Medicare & Medicaid Services (CMS) has ensured that the
approved clinical trials and approved registry have obtained valid numbers from http://www.clinicaltrials.gov
and that those numbers are maintained at http://www.cms.gov/Medicare/Coverage/Coverage-with-EvidenceDevelopment/Transcatheter- Aortic-Valve-Replacement-TAVR-.html on the CMS website. See the Background
and Additional Information Sections of this article for further details regarding these changes. Please make sure
that your billing staffs are aware of these changes.
Background
On May 1, 2012, CMS issued a National Coverage Determination (NCD) covering TAVR with CED. The TAVR NCD
is available at http://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx?NCDId=355 on the
CMS website.
TAVR (also known as TAVI or transcatheter aortic valve implantation) is a new technology for use in treating
aortic stenosis. A bioprosthetic valve is inserted percutaneously using a catheter and implanted in the orifice
of the native aortic valve. The procedure is performed in a cardiac catheterization lab or a hybrid operating
room/cardiac catheterization lab with advanced quality imaging and with the ability to safely accommodate
complicated cases that may require conversion to an open surgical procedure. The interventional cardiologist
and cardiac surgeon jointly participate in the intra-operative technical aspects of TAVR.
CR8255 requires that claims for TAVR carry an approved clinical trial number. Specific claims processing
instructions are as follows:
•
•
For professional claims processed on or after July 1, 2013, Medicare expects this numeric, 8- digit clinical
trial (CT) registry number to be preceded by the alpha characters of “CT” in Field 19 of paper Form CMS1500 claims or entered similarly in the electronic 837P in Loop 2300 REF01 (REF01=P4).
Professional claim lines for 0256T, 0257T, 0258T, 0259T, 33361, 33362, 33363, 33364, 33365, and 0318T
must have the CT registry number, a Q0 modifier, and a secondary diagnosis code of V70.7 (ICD10=Z00.6). Such claims lines will be returned as unprocessable if the CT registry number, the modifier
Q0, or the V70.7 (ICD-10=Z00.6) is not present.
Claims for TAVR submitted without the CT registry number will be returned as unprocessable with the following
messages:
•
Claims Adjustment Remarks Code (CARC) 16: “Claim/service lacks information which is needed for
adjudication. At least one Remark Code must be provided (may be comprised of either NCPDP Reject
July 2013
- page 66 -
•
•
•
•
Reason Code, or Remittance Advice Remark Code that is not an ALERT.)”;
Remittance Advice Remarks Code (RARC) MA50: “Missing/incomplete/invalid Investigational
Device Exemption number for FDA-approved clinical trial services.”;
RARC MA130: “Your claim contains incomplete and/or invalid information, and no appeal rights are
information.”; and
Group Code-Contractual Obligation (CO).
TAVR claims submitted without the Q0 modifier will be returned as unprocessable with the following messages:
•
•
•
•
CARC 4: “The procedure code is inconsistent with the modifier used or a required modifier is
missing. Note: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment
Information REF), if present.”;
RARC N29: “Missing documentation/orders/notes/summary/report/chart.”;
For claims processed on or after July 1, 2013, the claim lines for 0256T, 0257T, 0258T, 0259T,
33361, 33362, 33363, 33364, 33365 & 0318T will be returned as unprocessable when billed without secondary
diagnosis code V70.7 (ICD-10=Z00.6) with the following messages:
•
•
•
•
CARC 16: “Claim/service lacks information which is needed for adjudication. At least one Remark Code
must be provided (may be comprised of either NCPDP Reject Reason Code, or Remittance Advice
Remark Code that is not an ALERT.)”;
RARC M76: “Missing incomplete/invalid diagnosis or condition.”;
Medicare also requires the CT registry number on hospital claims for TAVR for inpatient hospital discharges
on or after July 1, 2013. Claims for TAVR for inpatient discharges on or after July 1, 2013, that do not have the
registry number will be rejected. Medicare is ensuring the presence of the procedure codes and associated
diagnosis and condition codes per CR7897/TR2552, issued September 24, 2012.
The official instruction, CR 8255 issued to your Medicare contractor regarding this change may be viewed at
http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R2689CP.pdf on the CMS
website. Add links to CR7897 and CR8168/TR2628, issued January 7, 2013, for additional claims processing
information.
Note: CR8255 does not eliminate the previous instructions contained in CRs 7897 and 8168 that were not
formally replaced/revised.
- page 67 -
July 2013
MM8269 - Ambulance Payment Reduction for Non-Emergency Basic
Life Support (BLS) Transports to and from Renal Dialysis Facilities
News Flash –
• “Medicare Remit Easy Print Software,” Fact Sheet, ICN 006740, Downloadable only.
This MLN Matters® Article is intended for providers and suppliers submitting claims to Medicare contractors
(Fiscal Intermediaries (FIs), carriers, and A/B Medicare Administrative Contractors (A/B MACs)) for services to
This article is based on Change Request (CR) 8269 which informs Medicare contractors about changes to the
Ambulance Fee Schedule (AFS). Effective for claims with dates of service on and after October 1, 2013, payment
for non-emergency Basic Life Support (BLS) transports of individuals with End-Stage Renal Disease (ESRD) to
and from renal dialysis treatment facilities will be reduced by 10%. The reduced rate will be calculated and
applied to Healthcare Common Procedure Code System (HCPCS) code A0428 when billed with destination
modifier code “G” or “J”, and the associated mileage, represented by HCPCS code A0425. A claim adjustment
reason code of 45 (Charge exceeds fee schedule/maximum allowable or contracted/legislated fee arrangement)
and group code “CO” (Contractual Obligation) will be on the remittance advice notice for claims for which a
Medicare contractor has applied the reduced AFS methodology. Make sure that your billing staffs are aware of
these changes.
Background
Section 637 of the American Taxpayer Relief Act of 2012 requires that, effective for transports occurring on and
after October 1, 2013, fee schedule payments for non-emergency BLS transports of individuals with End-Stage
Renal Disease (ESRD) to and from renal dialysis treatment be reduced by 10%. The payment reduction affects
transports to and from both hospital-based and freestanding renal dialysis treatment facilities for dialysis
services provided on a non-emergency basis. Non- emergency BLS ground transports are identified by HCPCS
code A0428. Ambulance transports to and from renal dialysis treatment are identified by origin/destination
modifier codes “G” (hospital- based ESRD) and “J” (freestanding ESRD facility) in either the origin or destination
position of an ambulance modifier.
Payment for ambulance transports, including items and services furnished in association with such transports,
are based on the AFS and includes a base rate payment plus a separate payment for mileage. The payment
reduction for non-emergency BLS transports to and from renal dialysis treatment applies to both the base rate
and the mileage reimbursement. The payment reduction will be applied to HCPCS code A0425 when billed with
HCPCS code A0428 and origin/destination modifier code “G” or “J” is present.
For ambulance services, suppliers and hospital-based ambulance providers must report an accurate origin and
destination modifier for each ambulance trip provided. Origin and destination modifiers used for ambulance
services are created by combining two alpha characters. Each alpha character, with
the exception of “X”, represents an origin code or a destination code. The pair of alpha codes creates a modifier.
The first position alpha code equals origin; the second position alpha code equals destination. The reduction
will be applied on claim lines containing HCPCS code A0428 with modifier code “G” or “J” in either the first
position (origin code) or second position (destination code) within the two-digit ambulance modifier code and
HCPCS code A0425, which reflects the mileage associated with the transport.
The official instruction, CR8269 issued to your FI, carrier, and A/B MAC regarding this change may be viewed at
http://www.cms.gov/Regulations-and- Guidance/Guidance/Transmittals/Downloads/R2703CP.pdf on the CMS
website.
July 2013
- page 68 -
If you have any questions, please contact your FI, carrier, or A/B MAC at their toll-free number, which may
MM8286 - Quarterly Healthcare Common Procedure Coding System
(HCPCS) Drug/Biological Code Changes - July 2013 Update
News Flash –
• “Medicare Remit Easy Print Software”, Fact Sheet, ICN 006740, downloadable
Medicare contractors (Fiscal Intermediaries (FIs), carriers, Regional Home Health Intermediaries (RHHIs), Durable
Medical Equipment Medicare Administrative Contractors (DME/MACs) and A/B Medicare Administrative
Contractors (A/B MACs)) for services to Medicare beneficiaries.
This article is based on Change Request (CR) 8286 which informs Medicare contractors about the updating of
specific drug and biological HCPCS codes which occurs quarterly. Make sure that your billing staffs are aware
of these changes. See the Background and Additional Information Sections of this article for further details
regarding these changes.
Key Points of CR8286
Effective for claims with dates of service on or after July 1, 2013, the following HCPCS codes will no
longer be payable for Medicare
• J3487: Injection, Zoledronic Acid (Zometa), 1mg.
• J3488: Injection, Zoledronic Acid (Reclast), 1mg.
• J9002: Injection, Doxorubicin Hydrochloride, Liposomal, Doxil, 10mg.
Effective for claims with dates of service on or after July 1, 2013, the following HCPCS codes will be payable for
Medicare:
• Q2033: Influenza Vaccine, Recombinant Hemagglutinin Antigens, For Intramuscular Use (Flublok).
• Q2050: Injection, Doxorubicin Hydrochloride, Liposomal, Not Otherwise Specified, 10mg.
• Q2051: Injection, Zoledronic Acid, not otherwise specified, 1mg.
Effective for claims with dates of service on or after July 1, 2013, the following HCPCS code will be accepted on
claims, but not payable by Medicare:
• Q0090: Levonorgestrel-Releasing Intrauterine Contraceptive System (SKYLA), 13.5 mg.
The official instruction, CR8286 issued to your FI, carrier, RHHI, DME/MAC, and A/B MAC regarding this change
may be viewed at http://www.cms.hhs.gov/Regulations-and- Guidance/Guidance/Transmittals/Downloads/
R2695CP.pdf on the CMS website.
If you have any questions, please contact your FI, carrier, RHHI, DME/MAC, or A/B MAC at their toll- free number,
which may be found at http://www.cms.gov/Research-Statistics-Data-and- Systems/Monitoring-Programs/
provider-compliance-interactive-map/index.html on the CMS website.
- page 69 -
July 2013
MM8291 - July Update to the Calendar Year (CY) 2013 Medicare
Physician Fee Schedule Database (MPFSDB)
News Flash –
• “The Basics of Medicare Enrollment for Physicians and Other Part B Suppliers,” Fact Sheet, ICN
903768, Downloadable only.
This MLN Matters® Article is intended for physicians and other providers who submit claims to Medicare
contractors (carriers, Fiscal Intermediaries (FIs), A/B Medicare Administrative Contractors (A/B MACs), and/or
Regional Home Health Intermediaries (RHHIs)) for services that are paid under the MPFS.
What you Need to Know
This article is based on Change Request (CR) 8291 and instructs Medicare contractors to download and implement a
new MPFSDB. Payment files were issued to your contractor(s) based upon the CY 2013 MPFS Final Rule (published in
the Federal Register on November 16, 2012) as modified by 1) the American Taxpayer Relief Act of 2012 (applicable
January 1, 2013), and 2) the Final Rule Correction Notice (published in the Federal Register in April, 2013).
This article details changes included in the July quarterly update to those payment files.
Background
The Social Security Act (Section 1848 (c)(4); see http://www.ssa.gov/OP_Home/ssact/title18/1848.htm on the
Internet) authorizes the Centers for Medicare & Medicaid Services (CMS) to establish ancillary policies necessary
to implement relative values for physicians’ services.
Payment files were issued to your contractor(s) based upon the CY 2013 Medicare Physician Fee Schedule
(MPFS) Final Rule (published in the Federal Register on November 16, 2012) as modified by the American
Taxpayer Relief Act of 2012 (applicable January 1, 2013; see http://www.gpo.gov/fdsys/pkg/BILLS-112hr8enr/
pdf/BILLS-112hr8enr.pdf on the Internet), and the Final Rule Correction Notice (published in the Federal
Register in April, 2013). For more information and access to the CY 2013 Final Rule, see the “Physician Fee
Schedule” webpage available at http://www.cms.gov/Medicare/Medicare-Fee-for-Service- Payment/
PhysicianFeeSched/index.html on the CMS website.
Summary of Changes in the July 2013 Update (Unless otherwise specified, the effective date is the date of
service.)
• Effective January 1, 2013, HCPCS Codes 37211, 37212 and 92071 will have their Bilateral Indicators are
being corrected to “1” = 150 percent payment adjustment applies if billed with modifier 50.
• Effective January 1, 2013, the TC component of the Nerve Conduction Test (95937) will have its
Physician Supervision Of Diagnostic Procedures Indicator changed to “7A” = “Supervision standards for
level 77 apply. In addition, the PT with ABPTS certification may personally supervise another PT, but
only the PT with ABPTS certification may bill.” (“77” = “Procedure must be performed by a PT with ABPTS
certification (TC & PC) or by a PT without certification under general supervision of a physician (TC only;
PC always physician)”). (This change reflects the policy of Transmittal B-01-28, its effective date for the
PT with ABPTS certification was July 1, 2001).
• Effective July 1, 2013, HCPCS Codes J3487, J3488, and J9002 will have their PROCSTAT indicators
changed from “E” to “I” = “Not valid for Medicare purposes.”
• Effective July 1, 2103, HCPCS Codes Q0090, Q2033, Q2051, Q2050, 0329T, 0330T, 0331T, 0332T, 0333T,
and 0334T will be added to the fee schedule.
• Effective January 1, 2013, HCPCS Codes G0460, “Autologous PRP for ulcers”, will be added to the fee
schedule. (For more information, please reference MLN Matters Article MM8213 at http://www.cms.
gov/Outreach-and-Education/Medicare-Learning-Network- MLN/MLNMattersArticles/Downloads/
MM8213.pdf )
• The following tables reflect additional changes made with their effective dates.
July 2013
- page 70 -
HCPCS Code
Procedure Status
Short Descriptor
0329T
0330T
0331T
C
C
C
Mntr io press Tear film img Heart symp
24hrs/>
uni/bi
image plnr
uni/bi
w/i&r
Effective Date
07/01/2013 07/01/2013 07/01/2013 07/01/2013 07/01/2013 07/01/2013
Work RVU
Full Non-Facility PE
RVU
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
Full Facility PE RVU
0.00
0.00
0.00
0.00
0.00
0.00
Malpractice RVU
0.00
0.00
0.00
0.00
0.00
0.00
9
9
9
9
9
9
9
9
9
9
9
9
9
9
9
9
9
9
Co-Surgery Indicator
Team Surgery
Indicator
9
9
9
9
9
9
9
9
9
9
9
9
PC/TC
9
9
9
9
9
9
Site of Service
9
9
9
9
9
9
Global Surgery
YYY
YYY
YYY
YYY
YYY
YYY
Pre
Intra
Post
Physician Supervision
Diagnostic Indicator
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
09
09
09
09
09
09
Diagnostic Family
Imaging Indicator
Non-Facility PE used
for OPPS Payment
Amount
99
99
99
99
99
99
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
MP Used for OPPS
Payment Amount
0.00
0.00
0.00
0.00
0.00
0.00
HCPCS Code
Procedure Status
0329T
C
0330T
C
0331T
C
0332T
C
0333T
C
0334T
C
Type of Service
1
4
4
4
1
1
Multiple Procedure
Indicator
Bilateral Surgery
Indicator
Assistant Surgery
Indicator
Facility PE used
for OPPS Payment
Amount
0332T
C
Heart symp
image plnr
spect
0333T
C
Visual ep
acuity
screen auto
0334T
C
Perq stablj
sacroiliac joint
- page 71 -
July 2013
Long Descriptor
Monitoring
of
intraocular
pressure for
24 hours or
longer,
unilateral
or bilateral,
with
interpretatio
n and report
Tear film
imaging,
unilateral
or bilateral,
with
interpretatio
n and report
Myocardial Myocardial
sympatheti sympathetic
c innervation innervation
imaging,
imaging,
planar
planar
qualitative qualitative
and
and
quantitative quantitative
assessmen assessment;
t;
with
tomographic
SPECT
Q2033
X
Influenza
Vaccine,
(Flublok)
Visual
Sacroiliac joint
evoked
stabilization
potential,
for arthrodesis,
screening of percutaneous
visual acuity, or minimally
automated invasive
(indirect
visualization),
includes
obtaining
and applying
autograft or
allograft
(structural or
morselized),
when
performed,
includes image
guidance
when
performed (eg,
CT or
fluoroscopic)
HCPCS Code
Procedure Status
Short Descriptor
G0460
C
Autologous
PRP for ulcers
Q0090
N
Skyla
13.5mg
Q2051
E
Zoledronic
acid 1mg
Q2050
E
Doxorubicin inj
10mg
Effective Date
01/01/2013
07/01/2013 07/01/2013 07/01/2013 07/01/2013
Work RVU
0.00
0.00
0.00
0.00
0.00
Full Non-Facility PE RVU
0.00
0.00
0.00
0.00
0.00
Full Facility PE RVU
0.00
0.00
0.00
0.00
0.00
Malpractice RVU
0.00
0.00
0.00
0.00
0.00
Multiple Procedure Indicator
0
9
9
9
9
Bilateral Surgery Indicator
0
9
9
9
9
Assistant Surgery Indicator
9
9
9
9
9
HCPCS Code
Procedure Status
G0460
C
Q0090
N
Q2033
X
Q2051
E
Q2050
E
Co-Surgery Indicator
0
9
9
9
9
Team Surgery Indicator
0
9
9
9
9
July 2013
- page 72 -
PC/TC
0
9
9
9
9
9
9
9
9
9
Pre
Intra
Post
000
0.00
0.00
0.00
XXX
0.00
0.00
0.00
XXX
0.00
0.00
0.00
XXX
0.00
0.00
0.00
XXX
0.00
0.00
0.00
Physician Supervision
Diagnostic Indicator
09
09
09
09
09
99
99
99
99
99
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
0.00
Site of Service
Global Surgery
Diagnostic Family Imaging
Indicator
Non-Facility PE used for OPPS
0.00
Payment Amount
Facility PE used for OPPS
Payment Amount
MP Used for OPPS Payment
Amount
Type of Service
Long Descriptor
1
9
Autologous
Levonorgest
platelet rich relplasma for
Releasing
chronic
Intrauterine
wounds/ulcer Contraceptiv
s, including
e System
phlebotomy, (SKYLA),
centrifugation, 13.5 mg
and all other
preparatory
procedures,
administration
and dressings,
per treatment
V
1,9
Influenza
Injection,
Vaccine,
Zoledronic
Recombinan t Acid, not
Hemagglutin otherwise
in Antigens, specified,
For
1mg
Intramuscula
r Use (Flublok)
1,9
Injection,
Doxorubicin
Hydrochloride,
Liposomal, Not
Otherwise
Specified,
10mg
Your Medicare contractor(s) will, in accordance with the “Medicare Claims Processing Manual” (Pub
100-4, Chapter 23, Section 30.1; see http://www.cms.gov/Regulations-and- Guidance/Guidance/Manuals/
Downloads/clm104c23.pdf on the CMS website) give you 30 days notice before implementing the changes
identified in CR 8291.
Note: Your Medicare contractor(s) will not search their files to either retract payment for claims already paid or
to retroactively pay claims. However, your Medicare contractor(s) will adjust claims brought to their attention.
The official instruction, CR 8291 issued to your Medicare contractor regarding this change may be viewed at http://
www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R2708CP.pdf on the CMS website.
- page 73 -
July 2013
MM8320 - Claim Status Category and Claim Status Codes Update
Claim Status Category and Claim Status Codes Update
Medicare contractors (Fiscal Intermediaries (FIs), carriers, Regional Home Health Intermediaries (RHHIs), Durable
Medical Equipment Medicare Administrative Contractors (DME/MACs) and A/B Medicare Administrative
Contractors (A/B MACs)) for services to Medicare beneficiaries.
This article is based on Change Request (CR) 8320 which requires Medicare contractors to use only national
Code Maintenance Committee-approved Claim Status Category Codes and Claim Status Codes when sending
Medicare healthcare status responses (277 transactions) to report the status of your submitted claim(s).
Proprietary codes may not be used in the X12 276/277 to report claim status. All code changes approved
during the June 2013 Committee meeting will be posted on or about July 1, 2013, at http://www.wpc-edi.com/
reference/codelists/healthcare/claim-status-category-codes and http://www.wpc-edi.com/reference/codelists/
healthcare/claim-status-codes on the Internet. Make sure that your billing staffs are aware of these changes.
• “The Basics of Medicare Enrollment for Physicians and Other Part B Suppliers,”
Fact Sheet, ICN 903768, Downloadable only.
Background
The Health Insurance Portability and Accountability Act (HIPAA) requires all health care benefit payers to use
only national Code Maintenance Committee-approved Claim Status Category Codes and Claim Status Codes
to explain the status of submitted claims. These codes, which have been adopted as the national standard to
explain the status of submitted claim(s), are the only such codes permitted for use in the X12 276/277 Health
Care Claim Status Request and Response format.
The national Code Maintenance Committee meets three times each year (February, June, and October) in
conjunction with the Accredited Standards Committee (ASC) X12 trimester meeting, and makes decisions
about additions, modifications, and retirement of existing codes. The Committee has decided to allow the
industry 6 months for implementation of the newly added or changed codes. Therefore, on the date of
implementation of CR8320 (October 7, 2013), your Medicare contractor must:
1) Complete the entry of all applicable code text changes and new codes;
2) Terminate the use of deactivated codes;
3) Use these new codes for editing all X12 276 transactions and reflect them in the X12 277 transactions that
they issue.
The official instruction, CR8320 issued to your Medicare contractor regarding this change may be viewed at
http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R2713CP.pdf on the CMS
website.
July 2013
- page 74 -
MM8325 - July Quarterly Update for 2013 Durable Medical
Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Fee
Schedule
News Flash –
• “The Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive
Bidding Program: Traveling Beneficiary,” Fact Sheet, ICN 904484, Downloadable only.
Medicare contractors (A/B Medicare Administrative Contractors (MACs), carriers, Regional Home Health
Intermediaries (RHHIs) and Durable Medical Equipment MACs (DME MACs) for DMEPOS items or services paid
under the DMEPOS fee schedule.
This article is based on Change Request (CR) 8325 and alerts providers and suppliers that the Centers for
Medicare & Medicaid Services (CMS) issued instructions updating the DMEPOS fee schedule payment amounts.
Be sure your billing staffs are aware of these changes.
Background
The DMEPOS fee schedules are updated on a quarterly basis, when necessary, in order to implement fee
schedule amounts for new and existing codes, as applicable and to apply changes in payment policies. The
quarterly update process for the DMEPOS fee schedule is documented in the “Medicare Claims Processing
Manual,” Chapter 23, Section 60 at https://www.cms.gov/Regulations-and- Guidance/Guidance/Manuals/
downloads/clm104c23.pdf on the CMS website.
Key Points of CR8325
• CR 8325 updates fees for Healthcare Common Procedure Coding System (HCPCS) codes E2378, L5859,
and L7902. These HCPCS codes were added to the HCPCS file effective January 1, 2013. Previously
these items were paid on a local fee schedule. If claims for these codes with dates of service on or after
January 1, 2013 have already been processed, they will be adjusted to reflect the new fees if you bring
the claims to your contractor’s attention.
• As part of this update fee schedule amounts are also established for HCPCS code K0009 (OtherManual
Wheelchair/Base). Payment on a fee schedule basis is mandated for all DME by section 1834(a) of the
Social Security Act (the Act), other than items that meet the definition of customized DME at 42 CFR
section 414.224 of the regulations. Effective July 1, 2013, payment for claims for manual wheelchairs,
that receive a HCPCS code verification of K0009 by the Pricing Data Analysis and Coding (PDAC)
contractor, will be made on a capped rental basis with the fee schedule amounts established and
updated in accordance with section1834 (a)(8) of the Act using data for all manual wheelchair codes
effective in 1986.
Diabetic Testing Supplies
Effective for dates of service on or after July 1, 2013, in accordance with Section 636(a) of the American Taxpayer
Relief Act (ATRA), the fee schedule amounts for non-mail order diabetic supplies are adjusted so that they are
equal to the single payment amounts for mail order diabetic supplies established in implementing the national
mail order competitive bidding program under Section 1847 of the Act. The national competitive bidding
program for mail order diabetic supplies takes effect July
1, 2013. Diabetic testing supplies are the supplies necessary for the effective use of a blood glucose monitor as
described by the HCPCS codes below:
• A4233 Replacement Battery, Alkaline (Other Than J Cell), For Use With Medically Necessary Home Blood
Glucose Monitor Owned By Patient, Each.
• A4234 Replacement Battery, Alkaline, J Cell, For Use with Medically Necessary Home Blood Glucose
Monitor Owned By Patient, Each.
- page 75 -
July 2013
•
•
•
•
•
•
A4235 Replacement Battery, Lithium, For Use with Medically Necessary Home Blood Glucose Monitor
Owned By Patient, Each.
A4236 Replacement Battery, Silver Oxide, For Use with Medically Necessary Home Blood Glucose
Monitor Owned By Patient, Each.
A4253 Blood Glucose Test or Reagent Strips for Home Glucose Monitor, Per 50 Strips.
A4256 Normal, Low and High Calibration Solution / Chips.
A4258 Spring-powered Device for Lancet, Each.
A4259 Lancets, Per Box of 100.
Also, the fee schedule amounts for non-mail order diabetic supplies listed above will be adjusted so that they
are equal to the single payment amounts for mail order diabetic supplies established under the national mail
order competition for diabetic testing supplies each time the single payment amounts are updated, which can
happen no less often than every three years as contracts are recompeted. The rules related to assignment of
claims for non-mail order diabetic testing supplies are not affected by this new law.
The definitions of mail order item and non-mail order item set forth in 42 CFR 414.402 are:
• Mail Order Item (KL HCPCS modifier) ─ any item shipped or delivered to the beneficiary’s home,
regardless of the method of delivery; and
• Non-Mail Order Item (KL modifier not applicable) ─ any item that a beneficiary or caregiver picks up in
person at a local pharmacy or supplier storefront.
Effective July 1, 2013, only national mail order contract suppliers will be paid by Medicare for diabetic testing
supplies other than those that a beneficiary or caregiver picks up in person at a local pharmacy or supplier
storefront. The single payment amount public use file for the national mail order
competitive bidding program is available at http://www.dmecompetitivebid.com/palmetto/cbicrd2.nsf/
DocsCat/Single%20Payment%20Amounts on the Internet.
The official instruction, CR 8325 issued to Medicare contractor regarding this change may be viewed at http://
www.cms.gov/Regulations-and- Guidance/Guidance/Transmittals/Downloads/R2709CP.pdf on the CMS
website.
Revised: MM8155 - Update to Chapter 15 of the Program Integrity
Manual (PIM)
News Flash –
Revised products from the Medicare Learning Network® (MLN)
• •“Long Term Care Hospital Prospective Payment System: High Cost Outliers,”
Fact Sheet, ICN 006396, Downloadable only.
Note: This article was revised on May 20, 2013, to reflect a updated change request (CR). The CR removed
changes that were made to Section 15.5.20 of the PIM. The CR release date, transmittal number and link to the
transmittal were also changed. All other information remains the same.
This MLN Matters® Article is intended for providers and suppliers submitting claims to Medicare Carriers, A/B
Medicare Administrative Contractors (A/B MACs), Fiscal Intermediaries (FIs), or Medicare Regional Home Health
Intermediaries (RHHIs) for services provided to Medicare beneficiaries.
July 2013
- page 76 -
The Centers for Medicare & Medicaid Services (CMS) issued Change Request (CR) 8155 to alert providers of
updates to Chapter 15 of the “Medicare Program Integrity Manual (PIM).” Chapter 15 deals with Medicare
provider enrollment and CR8155 highlights the issues below. Make sure your staff is
familiar with the Key Points of this MLN Matters® Article
Key Points
The following are the provider enrollment issues addressed in CR8155:
1. Owning and Managing Individuals: If your Medicare contractor is unsure as to whether the officers
and directors/board members of the enrolling provider or supplier’s corporate owner/parent also
serve as the enrolling provider or supplier’s officers and directors/board members, your contractor will
contact you for clarification.
2. If there is a Change in Correspondence or Special Payments Address/Change of Electronic Funds
Transfer (EFT) Information: Your Medicare contractor may confirm the change with the contract
person listed.
3. Rejections; Your Medicare contractor may reject an application that was signed more than 120 days
prior to the date on which the contractor received the application—assuming the provider or supplier
failed to furnish a new, appropriately-signed certification statement within 30 days of the contractor’s
request to do so.
4. Timeframe: Absent a CMS instruction or directive to the contrary, your Medicare contractor will send
a rejection letter no later than five business days after the contractor concludes that the provider or
supplier’s application should be rejected.
5. Be Aware: If your contractor rejects an application, it will either (1) keep the original application and
all supporting documents, or (2) make a copy or scan of the application and documents and return the
originals to the provider. If the contractor chooses the former approach and the provider requests a
copy of its application, the contractor may fax or mail it to the provider.
6. Potential Identity Theft or Other Fraudulent Activity: In conducting the verification activities
described in Section 15.7.5 of Chapter 15, if the contractor believes that a case of identity theft or other
fraudulent activity likely exists, the contractor will notify its Provider Enrollment Operations Group
Business Function Lead (PEOG BFL) at CMS immediately.
7. Non-Certified Suppliers and Individual Practitioners: Absent a CMS instruction or directive to the
contrary, an approval letter under Section 15.9.1 of Chapter 15 will be sent no later than five business
days after the contractor concludes that the provider or supplier meets all Medicare requirements and
that his/her/its application can be approved.
8. Unsolicited Additional Information: Any new or changed information that a provider submits
prior to the date the contractor finishes processing a previously submitted change request is no
longer considered to be an update to that change request; rather, it is considered to be and will be
processed as a separate change request. The contractor may process both changes simultaneously,
but the change that was submitted first will be processed to completion prior to the second one being
processed to completion.
9. Miscellaneous Policies: In situations where a provider with multiple PTANs is to be deactivated for
non-billing, the contractor will only deactivate the non-billing PTAN(s).
10. Partnerships: Only partnership interests in the enrolling provider need be disclosed in section 5 of the
Form CMS-855. Partnership interests in the provider’s indirect owners need not be reported. However,
if the partnership interest in the indirect owner results in a greater than 5 percent indirect ownership
interest in the enrolling provider, this indirect ownership interest would have to be disclosed in section 5.
11. Processing and Approval of Corrective Action Plans (CAPs): The contractor shall process a CAP
within 60 days of receipt. During this period, the contractor shall not toll the filing requirements
associated with a reconsideration request. If the contractor approves a CAP, it shall rescind the denial
or revocation, issue or restore billing privileges (as applicable), and notify the supplier thereof via
letter. For new or restored billing privileges – and unless stated otherwise in another CMS directive
or instruction - the effective date is based on the date the supplier came into compliance with all
Medicare requirements.
You can find the official instruction, CR8155, issued to your carrier, FI, A/B MAC, or RHHI by visiting http://www.
cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R462PI.pdf on the CMS website. The
entire revised Chapter 15 of the PIM is attached to that CR.
- page 77 -
July 2013
To review other changes to Chapter 15 issued in November of 2012, you may refer to MM8019 at http://
www.cms.gov/Outreach-and-Education/Medicare-Learning-Network- MLN/MLNMattersArticles/Downloads/
MM8019.pdf on the CMS website.
If you have any questions, please contact your carrier or A/B MAC at their toll-free number, which may be found
at http://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring- Programs/provider-complianceinteractive-map/index.html on the CMS website.
News Flash - Flu Season Isn’t Over – Continue to Recommend Vaccination - While each flu season is
different, flu activity typically peaks in February. Yet, even in February, the flu vaccine is still the best defense
against the flu. The CDC recommends yearly flu vaccination for everyone 6 months of age and older;
and although anyone can get the flu, adults 65 years and older are at greater risk for serious flu-related
complications that can lead to hospitalization and death. Every office visit is an opportunity to check your
patients’ vaccination status and encourage flu vaccination when appropriate. And getting vaccinated is just
as important for health care personnel who can get sick with the flu and spread it to family, colleagues and
patients. Be an example by getting your flu vaccine and know that you’re helping to reduce the spread of flu in
your community. Note: influenza vaccines and their administration fees are covered Part B benefits. Influenza
vaccines are NOT Part D-covered drugs. For More Information:
2012-2013 Seasonal Influenza Vaccines Pricing.
• MLN Matters® Article MM8047, “Influenza Vaccine Payment Allowances - Annual Update for 2012-2013
Season.”
• CMS Medicare Learning Network® 2012-2013 Seasonal Influenza Virus Educational Products and
• Resources and CMS Immunizations web pages for information on coverage and billing.
• HealthMap Vaccine Finder – a free, online service where users can find nearby locations offering flu
vaccines as well as other vaccines for adults.
• The CDC’s website offers a variety of provider resources for the 2012-2013 flu season.
Revised: MM8182 - Standardizing the Standard - Operating Rules for
Code Usage in Remittance Advice
News Flash –
Re-released products from the Medicare Learning Network® (MLN)
• “Internet-based Provider Enrollment, Chain and Ownership System (PECOS) Contact
Information,” Fact Sheet, ICN 903766, Downloadable only.
Note: This article was revised on May 10, 2013, to reflect a revised CR8182 issued on May 9. In the article,
the CR release date, transmittal number, and the Internet address for accessing the CR were revised. All
other information remains the same.
Medicare contractors (carriers, fiscal intermediaries (FIs), Regional Home Health Intermediaries, (RHHIs),
Medicare Administrative Contractors (A/B MACs), or Durable Medical Equipment Medicare Administrative
Contractors (DME MACs) for services to Medicare beneficiaries.
What You Need To Know
CR 8182, from which this article is taken, instructs your Medicare contractor to implement the Phase III Council
for Affordable Quality Healthcare (CAQH) Committee on Operating Rules for Information Exchange (CORE)
Electronic Funds Transfer (EFT) & Electronic Remittance Advice (ERA) Operating Rule Set for code usage in
Electronic Funds Transfer (EFT) & Electronic Remittance Advice (ERA) by January 1, 2014.
July 2013
- page 78 -
Background
The Health Insurance Portability and Accountability Act (HIPAA) amended Title XI of the Social Security Act
by adding Part C (Administrative Simplification), which requires the Secretary of the Department of Health
and Human Services (HHS) to adopt standards for certain transactions to enable health information to be
exchanged more efficiently; and to achieve greater uniformity in its transmission. (Please refer to: Public Law
104-191, Health Insurance Portability and Accountability Act of 1996, which you can find at http://aspe.hhs.gov/
admnsimp/pl104191.htm#1173 on the internet.)
Through the Affordable Care Act, Congress sought to promote implementation of electronic transactions
and achieve cost reduction and efficiency improvements by creating more uniformity in the implementation
of standard transactions and by mandating the adoption of a set of operating rules for each of the HIPAA
transactions. In December 2011 Congressional testimony, the National Committee on Vital and Health
Statistics (NCVHS) stated that the transition to Electronic Data Interchange (EDI) from paper has been slow and
“disappointing.” (You can find a copy of this testimony at http://www.ncvhs.hhs.gov/ on the internet.)
Note: The same rules will also apply to Standard Paper Remittance (SPR), as Medicare reports the same
standard codes in both electronic and paper formats of remittance advice.
The EFT & ERA Operating Rule Set includes the following rules: (Please note that CR 8182 focuses only on rule
numbers 3 and 4)
1. Phase III CORE 380 EFT Enrollment Data Rule;
2. Phase III CORE 382 ERA Enrollment Data Rule;
3. Phase III Core 360 Uniform Use of Claim Adjustment Reason Codes and Remittance
4. Advice Remark Codes (835) Rule;
5. CORE-required Code Combinations for CORE-defined Business Scenarios for the Phase III Core
Uniform Use of Claim Adjustment Reason Codes and Remittance Advice Remark Codes (835)
Rule;
6. Phase III CORE 370 EFT & ERA Re-association (CCD+/835) Rule; and Phase III CORE 350 Health Care Claim
Payment/Advice (835) Infrastructure Rule.
HIPAA initially mandated the standard code sets that a health plan may use to explain to providers/suppliers
how a claim/line has been adjudicated, and now the ERA/EFT Operating Rules under the Affordable Care Act
are mandating a standard use of those standard codes. The ERA/EFT Operating Rules mandate consistent and
uniform use of Remittance Advice (RA) codes (Group
Codes, Claim Adjustment Reason Codes (CARC) and Remittance Advice Remark Codes (RARC)) to mitigate
confusion that may result in:
• Unnecessary manual provider follow-up;
• Faulty electronic secondary billing;
• Inappropriate write-offs of billable charges;
• Incorrect billing of patients for co-pays and deductibles, and/or
• Posting delay.
Business Scenarios
The CORE Phase III ERA/EFT Operating Rules define four Business Scenarios, and specify the maximum set of the
standard codes that a health plan may use. This list will be updated and maintained by a CORE Task Group when
the two code committees update the lists and/or when there is need for additional combinations based on
business policy change and/or Federal/State Mandate.
The maximum set of CORE-defined code combinations to convey detailed information about the denial
or adjustment for each business scenario is specified in the document: Committee on Operating Rules for
Information Exchange (CORE®)-required Code Combinations for CORE-defined
Business Scenarios for the Phase III CORE 360 Uniform Use of Claim Adjustment Reason Codes and Remittance
Advice Remark Codes (835) Rule), that is an attachment to CR 8182. This list of code combinations will be
updated by CAQH CORE on a regular basis, and for Medicare, the updated list will be a part of the recurring
code update CR (published 4 times a year) in the future.
- page 79 -
July 2013
Additionally, you should be aware that Medicare is implementing the code combinations that relate to these
four scenarios in October 2013, as follows:
Scenario #1 - Additional Information Required - Missing/Invalid/Incomplete
Documentation
This scenario refers to situations in which additional documentation is needed from the billing provider
or an ERA from a prior payer.
Scenario #2 - Additional Information Required – Missing/Invalid/Incomplete Data from
Submitted Claim
This scenario refers to situations in which additional data are needed from the billing provider for
missing or invalid data on the submitted claim, e.g., an 837 or D.0.
Scenario #3 - Billed Service Not Covered by Health Plan
This scenario refers to situations in which the billed service is not covered by the health plan.
Scenario #4 - Benefit for Billed Service Not Separately Payable
This scenario refers to situations in which the billed service or benefit is not separately payable by the
health plan.
Finally, by October 7, 2013, the Medicare Remit Easy Print (MREP) and PC Print software will be modified as necessary.
The official instruction, CR8182, issued to your carrier, FI, RHHI, A/B MAC, or DME MAC regarding this change
may be viewed at http://www.cms.gov/Regulations-and- Guidance/Guidance/Transmittals/Downloads/
R1233OTN.pdf on the CMS website You will find a copy of the document: Committee on Operating Rules for
Information Exchange (CORE®)-required Code Combinations for CORE-defined Business Scenarios for the Phase
III CORE 360 Uniform Use of Claim Adjustment Reason Codes and Remittance Advice Remark Codes (835) Rule)
as an attachment to that CR.
If you have any questions, please contact your carrier, FI, RHHI, A/B MAC, or DME MAC at their toll- free number,
which may be found at http://www.cms.gov/Research-Statistics-Data-and- Systems/Monitoring-Programs/
provider-compliance-interactive-map/index.html on the CMS website.
News Flash - Flu Season Isn’t Over – Continue to Recommend Vaccination - While each flu season is
different, flu activity typically peaks in February. Yet, even in February, the flu vaccine is still the best defense
against the flu. The CDC recommends yearly flu vaccination for everyone 6 months of age and older;
and although anyone can get the flu, adults 65 years and older are at greater risk for serious flu-related
complications that can lead to hospitalization and death. Every office visit is an opportunity to check your
patients’ vaccination status and encourage flu vaccination when appropriate. And getting vaccinated is just
as important for health care personnel who can get sick with the flu and spread it to family, colleagues and
patients. Be an example by getting your flu vaccine and know that you’re helping to reduce the spread of flu in
your community. Note: influenza vaccines and their administration fees are covered Part B benefits. Influenza
vaccines are NOT Part D-covered drugs.
For More Information:
• 2012-2013 Seasonal Influenza Vaccines Pricing.
• MLN Matters® Article MM8047, “Influenza Vaccine Payment Allowances - Annual Update for 20122013 Season.”
• CMS Medicare Learning Network® 2012-2013 Seasonal Influenza Virus Educational Products and
Resources and CMS Immunizations web pages for information on coverage and billing.
• HealthMap Vaccine Finder – a free, online service where users can find nearby locations offering flu
vaccines as well as other vaccines for adults.
• The CDC’s website offers a variety of provider resources for the 2012-2013 flu season.
July 2013
- page 80 -
Revised: SE0711 – Reminder - Medicare Now Provides Coverage for
Eligible Medicare Beneficiaries of a One-Time Ultrasound Screening
for Abdominal Aortic Aneurysms (AAA) When Referred for this
Screening as a Result of the Initial Preventive Physical Examination
(“Welcome to Medicare” Physical Exam)
Note: This article was updated on May 22, 2013, to update all statements on page 2 regarding when a
beneficiary is eligible for the IPPE. All other information remains unchanged.
All Medicare fee-for-service (FFS) physicians, providers, suppliers, and other health care professionals, who
furnish or provide referrals for and/or file claims for the initial preventive physical examination (IPPE) and the
ultrasound screening for abdominal aortic aneurysms (AAA).
This article conveys no new policy information. This article is for informational purposes only and serves
as a reminder that Medicare provides coverage of a one-time initial preventive physical examination and a onetime preventive ultrasound screening for abdominal aortic aneurysms subject to certain coverage, frequency,
and payment limitations. The Centers for Medicare & Medicaid Services (CMS) needs your help to get the word
out and to encourage eligible beneficiaries to take full advantage of these benefits and all preventive services
and screenings covered by Medicare.
Background
In January 2005, the Medicare program expanded the number of preventive services available to Medicare
beneficiaries, as a result of Section 611 of the Medicare Prescription Drug, Improvement, and Modernization Act
(MMA) of 2003, to include coverage under Medicare Part B of a one-time IPPE, also referred to as the “Welcome
to Medicare” physical exam, for all Medicare beneficiaries whose Medicare Part B effective date began on or
after January 1, 2005.
On January 1, 2007, Medicare further expanded the number of preventive benefits, as provided for in
Section 5112 of the Deficit Reduction Act (DRA) of 2005, to include coverage under Medicare Part B of a
one-time preventive ultrasound screening for the early detection of abdominal aortic aneurysms (AAA) for
at risk beneficiaries as part of the IPPE. Both benefits (the IPPE and AAA) are subject to certain eligibility
and other limitations.
The information in this Special Edition MLN Matters article reminds health care professionals that Medicare now
pays for these benefits as well as a broad range of other preventive services and screenings. CMS needs your
help to ensure that patients new to Medicare receive their “Welcome to Medicare” physical exam within the first
12 months of their effective date in Medicare Part B and those beneficiaries at risk for AAA receive a referral for
the preventive ultrasound screening as part of their “Welcome to Medicare” physical exam.
Benefit Coverage Summary
The Initial Preventive Physical Examination (“Welcome to Medicare” Physical Exam)
Effective for dates of service on or after January 1, 2005: Medicare beneficiaries whose Medicare Part B effective
date is on or after January 1, 2005, are covered for a one-time IPPE visit. A beneficiary is only eligible for an IPPE
within the first 12 months of his or her Medicare Part B effective date. The IPPE is a preventive evaluation and
management (E/M) service that includes the following seven components:
1.
2.
3.
4.
A review of an individual’s medical and social history with attention to modifiable risk factors,
A review of an individual’s potential (risk factors) for depression,
A review of the individual’s functional ability and level of safety,
An examination to include an individual’s height, weight, blood pressure measurement, and visual acuity
screen,
5. Performance of an electrocardiogram (EKG) and interpretation of the EKG,
6. Education, counseling, and referral based on the results of the review and evaluation services described in
- page 81 -
July 2013
the previous five elements, and
7. Education, counseling, and referral (including a brief written plan such as a checklist provided to the
individual for obtaining the appropriate screenings and other preventive services that are covered as
separate Medicare Part B benefits).
Important reminders about the IPPE:
1. The IPPE is a unique benefit available only for beneficiaries new to the Medicare Program and must be
received within the first 12 months of the effective date of their Medicare Part B coverage.
2. This exam is a preventive physical exam and not a “routine physical checkup” that some seniors may receive
every year or two from their physician or other qualified non-physician practitioner. Medicare does not
provide coverage for routine physical exams.
The Part B deductible and coinsurance/copayment no longer apply to the IPPE benefit. (See note above)
Note: The deductible does not apply for an IPPE provided in a Federally Qualified Health Center (FQHC). Only
the coinsurance/copayment applies.
Other preventive services and screenings covered under Medicare Part B include: Adult immunizations (flu,
pneumococcal, and hepatitis B), bone mass measurements, cardiovascular screening, diabetes screening,
glaucoma screening, screening mammograms, screening Pap test and pelvic exam, colorectal and prostate
cancer screenings, diabetes self-management training, medical nutrition therapy for beneficiaries diagnosed
with diabetes or renal disease, and smoking and tobacco-use cessation counseling. Benefits are subject to
certain eligibility and other limitations.
NOTE: The IPPE/”Welcome to Medicare” physical exam does not include any clinical laboratory tests. The
physician, qualified non-physician practitioner, or hospital may also provide and bill separately for the
preventive services and screenings that are currently covered and paid for by Medicare Part B. (See the
Additional Information section below for links to MLN Matters articles MM3771 and MM3638, which provide
detailed coverage criteria and billing information about the IPPE benefit.)
Preventive Ultrasound Screening for Abdominal Aortic Aneurysms (AAA)
Effective for dates of service on or after January 1, 2007, Medicare will pay for a one-time preventive ultrasound
screening for AAA for beneficiaries who are at risk (has a family history of AAA or is a man age 65 to 75 who
has smoked at least 100 cigarettes in his lifetime). Eligible beneficiaries must receive a referral for the screening
as a result of their “Welcome to Medicare” physical exam. There is no Part B deductible or coinsurance/
copayment applied to this benefit.
IMPORTANT NOTE: Only Medicare beneficiaries who receive a referral from their physician or other qualified
non-physician practitioner for the preventive ultrasound screening, as part of their “Welcome to Medicare”
physical exam, will be covered for the AAA benefit. (See the Additional Information section below for a link to
MLN Matters article MM5235, which provides detailed coverage criteria and billing information about the AAA
benefit.)
For more information about Medicare’s coverage criteria and billing procedures for the AAA and
IPPE benefits, refer to the following MLN Matters articles:
•
•
•
MM5235 (2006), Implementation of a One-Time Only Ultrasound Screening for Abdominal Aortic
Aneurysms (AAA), Resulting from a Referral from an Initial Preventive Physical Examination, http://
www.cms.gov/outreach-and-education/medicare-learning-network- mln/mlnmattersarticles/
downloads/MM5235.pdf
MM3771 (2005), MMA – Clarification for Outpatient Prospective Payment system (OPPS) Hospitals
Billing the Initial Preventive Physical Exam (IPPE), http://www.cms.gov/outreach- and-education/
medicare-learning-network-mln/mlnmattersarticles/downloads/MM3771.pdf
MM3638 (2004), MMA – Initial Preventive Physical Examination, http://www.cms.gov/outreach-andeducation/medicare-learning-network-mln/mlnmattersarticles/downloads/MM3638.pdf on the CMS
website.
July 2013
- page 82 -
CMS has also developed a variety of educational products and resources to help health care professionals
and their staff, become familiar with coverage, coding, billing, and reimbursement for all preventive services
covered by Medicare.
•
•
The MLN Preventive Services Educational Products Web Page ~ provides descriptions and ordering
information for all provider specific educational products related to preventive services. The web
page is located at http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/
MLNProducts/index.html on the CMS website.
The CMS website provides information for preventive service covered by Medicare is at http://www.
cms.gov/Medicare/Prevention/PrevntionGenInfo/index.html on the CMS website..
For products to share with your Medicare patients, visit http://www.medicare.gov/ on the Internet.
Revised: SE1305 - Full Implementation of Edits on the Ordering/
Referring Providers in Medicare Part B, DME, and Part A Home
Health Agency (HHA) Claims (Change Requests 6417, 6421, 6696,
and 6856)
News Flash – In September 2012, the Centers for Medicare & Medicaid Services (CMS) announced the
availability of a new electronic mailing list for those who refer Medicare beneficiaries for Durable Medical
Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS). Referral agents play a critical role in providing
information and services to Medicare beneficiaries. To ensure you give Medicare patients the most current
DMEPOS Competitive Bidding Program information, CMS strongly encourages you to review the information
sent from this new electronic mailing list. In addition, please share the information you receive from the mailing
list and the link to the “mailing list for referral agents” subscriber webpage with others who refer Medicare
beneficiaries for DMEPOS. Thank you for signing up!
Important Announcement on April 25, 2013: Temporary Delay in Implementing Ordering and Referring
Denial Edits – Due to technical issues, the implementation of the Phase 2 denial edits is being delayed.
These edits would have checked certain claims for an approved or validly opted-out physician or nonphysician who is an eligible specialty type with a valid individual National Provider Identifier (NPI). If this
information were missing or incorrect, the following types of claims would deny:
•
•
•
•
Claims from laboratories for ordered tests;
Claims from imaging centers for ordered imaging procedures;
Claims from suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies
(DMEPOS) for ordered DMEPOS; and
Claims from Part A Home Health Agencies (HHAs).
CMS will advise you of the new implementation date in the near future. In the interim, informational
messages will continue to be sent for those claims that would have been denied had the edits been in
place. Language regarding beneficiary liability has also been updated in this version of the article.
Claims from billing providers and suppliers that are denied because they failed the ordering/referring edit shall
not expose a Medicare beneficiary to liability. Therefore, an Advance Beneficiary Notice is not appropriate in
this situation. This is consistent with the preamble to the final rule which implements the Affordable Care Act
requirement that physicians and eligible professionals enroll in Medicare to order and certify certain Medicare
covered items and services including home health, DMEPOS, imaging and clinical laboratory.
Note: This article was previously revised on April 19, 2013, to add references to the CMS-1450 form and to add
question h. on page 9. Previously, it was revised on April 3, 2013, to advise providers to not include middle
names and suffixes of ordering/referring providers on paper claims. Physicians and others who are eligible
- page 83 -
July 2013
to order and refer items or services need to establish their Medicare enrollment record with a valid NPI and
must be of a specialty that is eligible to order and refer. If the ordering/referring provider is listed on the claim,
the edits will verify that the provider is enrolled in Medicare. The edits will compare the first letter of the first
name and the first four letters of the last name. When submitting the CMS-1500 or the CMS-1450, please only
include the first and last name as it appears on the ordering and referring file found at http://www.cms.
gov/Medicare/Provider-Enrollment-and- Certification/MedicareProviderSupEnroll/MedicareOrderingandReferring.
html on the CMS website.
This MLN Matters® Special Edition Article is intended for:
•
•
•
•
Physicians and non-physician practitioners (including interns, residents, fellows, and those who are
employed by the Department of Veterans Affairs (DVA), the Department of Defense (DoD), or the Public
Health Service (PHS)) who order or refer items or services for Medicare beneficiaries,
Part B providers and suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies
(DMEPOS) who submit claims to carriers, Part A/B Medicare Administrative Contractors (MACs), and
DME MACs for items or services that they furnished as the result of an order or a referral, and
Part A Home Health Agency (HHA) services who submit claims to Regional Home Health Intermediaries
(RHHIs), Fiscal Intermediaries (FIs, who still maintain an HHA workload), and Part A/B MACs.
Optometrists may only order and refer DMEPOS products/services and laboratory and X-Ray services
payable under Medicare Part B.
If you order or refer items or services for Medicare beneficiaries and you do not have a Medicare enrollment
record, you need to submit an enrollment application to Medicare. You can do this using the Internet-based
Provider Enrollment, Chain, and Ownership System (PECOS) or by completing the paper enrollment application
(CMS-855O). Review the background and additional information below and make sure that your billing staff is
aware of these updates.
What Providers Need to Know
Phase 1: Informational messaging: Began October 5, 2009, to alert the billing provider that the identification
of the ordering/referring provider is missing, incomplete, or invalid, or that the ordering/referring provider is
not eligible to order or refer. The informational message on an adjustment claim that did not pass the edits
indicated the claim/service lacked information that was needed for adjudication.
Important Announcement on April 25, 2013: Temporary Delay in Implementing Ordering and Referring
Denial Edits – Due to technical issues, implementation of the Phase 2 denial edits is being delayed.
These edits would have checked certain claims for an approved or validly opted-out physician or nonphysician who is an eligible specialty type with a valid individual National Provider Identifier (NPI). If this
information were missing or incorrect, the following types of claims would deny:
•
•
•
•
Claims from suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies
(DMEPOS) for ordered DMEPOS; and
Claims from Part A Home Health Agencies (HHA).
Phase 2: CMS has not determined a date to turn on the Phase 2 edits to deny Part B, DME, and
Part A HHA claims that fail the ordering/referring provider edits.
Physicians and others who are eligible to order and refer items or services need to establish their Medicare
enrollment record and must be of a specialty that is eligible to order and refer. Physicians and others who are
eligible to order and refer items or services need to establish their Medicare enrollment record with a valid
NPI and must be of a specialty that is eligible to order and refer. If the ordering/referring provider is listed
on the claim, the edits will verify that the provider is enrolled in Medicare. The edits will compare the first
letter of the first name and the first four letters of the last name. When submitting the CMS-1500 or the
CMS-1450, please only include the first and last name as it appears on the ordering and referring file
found on http://www.cms.gov/Medicare/Provider-Enrollment-and- Certification/MedicareProviderSupEnroll/
July 2013
- page 84 -
MedicareOrderingandReferring.html on the CMS website. Middle names (initials) and suffixes (such as MD, RPNA
etc.) should not be listed in the ordering/referring fields.
All enrollment applications, including those submitted over the Internet, require verification of the information
reported. Sometimes, Medicare enrollment contractors may request additional information in order to process
the enrollment application. Waiting too long to begin this process could mean that your enrollment application
may not be processed prior to the implementation date of the ordering/referring Phase 2 provider edits.
Background
The Affordable Care Act, Section 6405, “Physicians Who Order Items or Services are required to be Medicare
Enrolled Physicians or Eligible Professionals,” requires physicians or other eligible professionals to be enrolled
in the Medicare Program to order or refer items or services for Medicare beneficiaries. Some physicians or other
eligible professionals do not and will not send claims to a Medicare contractor for the services they furnish and
therefore may not be enrolled in the Medicare program. Also, effective January 1, 1992, a physician or supplier
that bills Medicare for a service or item must show the name and unique identifier of the attending physician on
the claim if that service or item was the result of an order or referral. Effective May 23, 2008, the unique identifier
was determined to be the National Provider Identifier (NPI). The Centers for Medicare & Medicaid Services (CMS)
has implemented edits on ordering and referring providers when they are required to be identified in Part B,
DME, and Part A HHA claims from Medicare providers or suppliers who furnished items or services as a result of
orders or referrals.
Below are examples of some of these types of claims:
•
•
•
•
Claims from suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) for
ordered DMEPOS; and
Claims from Part A Home Health Agencies (HHA).
Only physicians and certain types of non-physician practitioners are eligible to order or refer items or services
for Medicare beneficiaries. They are as follows:
•
•
•
•
•
•
•
•
Physicians (doctor of medicine or osteopathy, doctor of dental medicine, doctor of dental surgery,
doctor of podiatric medicine, doctor of optometry, optometrists may only order and refer DMEPOS
products/services and laboratory and X-Ray services payable under Medicare Part B.)
Physician Assistants,
Clinical Nurse Specialists,
Nurse Practitioners,
Clinical Psychologists,
Interns, Residents, and Fellows,
Certified Nurse Midwives, and
Clinical Social Workers.
CMS emphasizes that generally Medicare will only reimburse for specific items or services when those items or
services are ordered or referred by providers or suppliers authorized by Medicare statute and regulation to do
so. Claims that a billing provider or supplier submits in which the ordering/referring provider or supplier is not
authorized by statute and regulation will be denied as a non-covered
service. The denial will be based on the fact that neither statute nor regulation allows coverage of certain
services when ordered or referred by the identified supplier or provider specialty.
CMS would like to highlight the following limitations:
•
•
Chiropractors are not eligible to order or refer supplies or services for Medicare beneficiaries. All services
ordered or referred by a chiropractor will be denied.
Home Health Agency (HHA) services may only be ordered or referred by a Doctor of Medicine (M.D.),
Doctor of Osteopathy (D.O.), or Doctor of Podiatric Medicine (DPM). Claims for HHA services ordered by
any other practitioner specialty will be denied.
- page 85 -
July 2013
•
Optometrists may only order and refer DMEPOS products/services, and laboratory and X-Ray services
payable under Medicare Part B.
Questions and Answers Relating to the Edits
1. What are the ordering and referring edits?
The edits will determine if the Ordering/Referring Provider (when required to be identified in Part B, DME, and
Part A HHA claims) (1) has a current Medicare enrollment record and contains a valid National Provider Identifier
(NPI) (the name and NPI must match), and (2) is of a provider type that is eligible to order or refer for Medicare
beneficiaries (see list above).
2. Why did Medicare implement these edits?
These edits help protect Medicare beneficiaries and the integrity of the Medicare program.
3. How and when will these edits be implemented?
These edits were implemented in two phases:
Phase 1 -Informational messaging: Began October 5, 2009, to alert the billing provider that the identification
of the ordering/referring provider is missing, incomplete, or invalid, or that the ordering/referring provider is
not eligible to order or refer. The informational message on an adjustment claim that did not pass the edits
indicated the claim/service lacked information that
was needed for adjudication. The informational messages used are identified below: For Part B providers and
suppliers who submit claims to carriers:
N264
Missing/incomplete/invalid ordering provider name
N265
Missing/incomplete/invalid ordering provider primary identifier
For adjusted claims, the Claims Adjustment Reason Code (CARC) code 16 (Claim/service lacks information which
is needed for adjudication.) is used.
DME suppliers who submit claims to carriers (applicable to 5010 edits):
N544
Alert: Although this was paid, you have billed with a referring/ordering provider that does not
match our system record. Unless, corrected, this will not be paid in the future
For Part A HHA providers who order and refer, the claims system initially processed the claim and added the
following remark message:
N272
Missing/incomplete/invalid other payer attending provider identifier
For adjusted claims the CARC code 16 and/or the RARC code N272 was used.
CMS has taken actions to reduce the number of informational messages.
In December 2009, CMS added the NPIs to more than 200,000 PECOS enrollment records of physicians and nonphysician practitioners who are eligible to order and refer but who had not updated their PECOS enrollment
records with their NPIs.1
On January 28, 2010, CMS made available to the public, via the Downloads section of the “Ordering Referring
Report” page on the Medicare provider/supplier enrollment website, a file containing the NPIs and the names
of physicians and non-physician practitioners who have current enrollment records in PECOS and are of a type/
specialty that is eligible to order and refer. The file, called the Ordering Referring Report, lists, in alphabetical
order based on last name, the NPI and the name (last name, first name) of the physician or non-physician
July 2013
- page 86 -
practitioner. To keep the available information up to date, CMS will replace the Report twice a week. At
any given time, only one Report (the most current) will be available for downloading. To learn more about
the Report and to download it, go to http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/
MedicareProviderSupEnroll/index.html; click on “Ordering & Referring Information” (on the left). Information
about the Report will be displayed.
Phase 2: In Phase 2, if the ordering/referring provider does not pass the edits, the claim will be denied. This
means that the billing provider will not be paid for the items or services that were furnished based on the order
or referral. CMS has not determined a date to turn on the Phase 2 edits.
Below are the denial edits for Part B providers and suppliers who submit claims to carriers and/or
MACs, including DME MACs:
1 NPIs were added only when the matching criteria verified the NPI.
254D
Referring/Ordering Provider Not Allowed To Refer
255D
Referring/Ordering Provider Mismatch
289D
Referring/Ordering Provider NPI Required
CARC code 16 and/or the RARC code N264 and N265 shall be used for denied or adjusted claims.
Below are the denial edits for Part A HHA providers who submit claims:
37236
This reason
code will
assign when:
37237
This reason
code will
assign when:
•
The statement “From” date on the claim is on or after the date the phase 2 edits are
turned on
•
The type of bill is ‘32’ or ‘33’
•
Covered charges or provider reimbursement is greater than zero but the attending
physician NPI on the claim is not present in the eligible attending physician file from
PECOS or the attending physician NPI on the claim is present in the eligible attending
physician files from PECOS but the name does not match the NPI record in the eligible
attending physician files from EPCOS or the specialty code is not a valid eligible code
•
The statement “From” date on the claim is on or after the date the phase 2 edits are
turned on
•
The type of bill is ‘32’ or ‘33’
•
The type of bill frequency code is ‘7’ or ‘F-P’
•
Covered charges or provider reimbursement is greater than zero but the attending
physician NPI on the claim is not present in the eligible attending physician file from
PECOS or the attending physician NPI on the claims is present in the eligible attending
physician files from PECOS but the name does not match the NPI record in the eligible
attending physician files from PECOS or the specialty code is not a valid eligible code
Effect of Edits on Providers
I order and refer. How will I know if I need to take any sort of action with respect to these two edits?
In order for the claim from the billing provider (the provider who furnished the item or service) to be paid by
Medicare for furnishing the item or service that you ordered or referred, you, the ordering/referring provider,
need to ensure that:
a. You have a current Medicare enrollment record.
• If you are not sure you are enrolled in Medicare, you may:
- page 87 -
July 2013
i.
ii.
iii.
iv.
Check the Ordering Referring Report and if you are on that report, you have a current
enrollment record in Medicare and it contains your NPI;
Contact your designated Medicare enrollment contractor and ask if you have an enrollment
record in Medicare and it contains the NPI; or
Use Internet-based PECOS to look for your Medicare enrollment record (if no record is
displayed, you do not have an enrollment record in Medicare).
If you choose iii, please read the information on the Medicare provider/supplier enrollment web
page about Internet-based PECOS before you begin.
b. If you do not have an enrollment record in Medicare.
• You need to submit either an electronic application through the use of internet-based PECOS or a
paper enrollment application to Medicare.
i.
For paper applications - fill it out, sign and date it, and mail it, along with any required
supporting paper documentation, to your designated Medicare enrollment contractor.
ii.
For electronic applications – complete the online submittal process and either e-sign or
mail a printed, signed, and dated Certification Statement and digitally submit any required
supporting paper documentation to your designated Medicare enrollment contractor.
iii.
In either case, the designated enrollment contractor cannot begin working on your application
until it has received the signed and dated Certification Statement.
iv.
If you will be using Internet-based PECOS, please visit the Medicare provider/supplier
enrollment web page to learn more about the web-based system before you attempt
to use it. Go to http://www.cms.gov/Medicare/Provider-Enrollment-and- Certification/
MedicareProviderSupEnroll/index.html, click on “Internet-based PECOS” on the left-hand side,
and read the information that has been posted there. Download and read the documents in the
Downloads Section on that page that relate to physicians and non- physician practitioners. A
link to Internet-based PECOS is included on that web page.
v.
If you order or refer items or services for Medicare beneficiaries and you do not have a Medicare
enrollment record, you need to submit an enrollment application to Medicare. You can do this
using Internet-based PECOS or by completing the paper enrollment application (CMS-855O).
Enrollment applications are available via internet-based PECOS or .pdf for downloading from
the CMS forms page (http://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/index.html).
c. You are an opt-out physician and would like to order and refer services. What should you do?
If you are a physician who has opted out of Medicare, you may order items or services for Medicare
beneficiaries by submitting an opt-out affidavit to a Medicare contractor within your specific
jurisdiction. Your opt-out information must be current (an affidavit must be completed every 2 years,
and the NPI is required on the affidavit).
d. You are of a type/specialty that can order or refer items or services for Medicare beneficiaries.
When you enrolled in Medicare, you indicated your Medicare specialty. Any physician specialty
(Chiropractors are excluded) and only the non-physician practitioner specialties listed above in this
article are eligible to order or refer in the Medicare program.
e. I bill Medicare for items and services that were ordered or referred. How can I be sure that my
claims for these items and services will pass the Ordering/Referring Provider edits?
•
You need to ensure that the physicians and non-physician practitioners from whom you accept
orders and referrals have current Medicare enrollment records and are of a type/specialty that is
eligible to order or refer in the Medicare program. If you are not sure that the physician or nonphysician practitioner who is ordering or referring items or services meets those criteria, it is
recommended that you check the Ordering Referring Report described earlier in this article.
•
Ensure you are correctly spelling the Ordering/Referring Provider’s name.
•
If you furnished items or services from an order or referral from someone on the Ordering Referring
Report, your claim should pass the Ordering/Referring Provider edits.
•
The Ordering Referring Report will be replaced twice a week to ensure it is current. It is possible
July 2013
- page 88 -
that you may receive an order or a referral from a physician or non-physician practitioner who is not
listed in the Ordering Referring Report but who may be listed on the next Report.
f. Make sure your claims are properly completed.
•
On paper claims (CMS-1500), in item 17, only include the first and last name as it appears on the
Ordering and Referring file found on CMS.gov.
•
On paper claims (CMS-1450), you would capture the attending physician’s last name, first name and
NPI on that form in the applicable sections. On the most recent form it would be fields in FL 76.
•
On paper claims (CMS-1500 and CMS-1450), do not enter “nicknames”, credentials (e.g., “Dr.”, “MD”,
“RPNA”, etc.) or middle names (initials) in the Ordering/Referring name field, as their use could cause
the claim to fail the edits.
•
Ensure that the name and the NPI you enter for the Ordering/Referring Provider belong to a
physician or non-physician practitioner and not to an organization, such as a group practice that
employs the physician or non-physician practitioner who generated the order or referral.
•
Make sure that the qualifier in the electronic claim (X12N 837P 4010A1) 2310A NM102 loop is a 1
(person). Organizations (qualifier 2) cannot order and refer.
If there are additional questions about the informational messages, Billing Providers should contact their local
carrier, A/B MAC, or DME MAC.
Claims from billing providers and suppliers that are denied because they failed the ordering/referring edit shall
not expose a Medicare beneficiary to liability. Therefore, an Advance Beneficiary Notice is not appropriate in
this situation. This is consistent with the preamble to the final rule which implements the Affordable Care Act
requirement that physicians and eligible professionals enroll in Medicare to order and certify certain Medicare
covered items and services including home health, DMEPOS, imaging and clinical laboratory.
g. What if my claim is denied inappropriately?
If your claim did not initially pass the Ordering/Referring provider edits, you may file an appeal through
the standard claims appeals process.
h. How will the technical vs. professional components of imaging services be affected by the edits?
Consistent with the Affordable Care Act and 42 CFR 424.507, suppliers submitting claims for imaging
services must identify the ordering or referring physician or practitioner. Imaging suppliers covered
by this requirement include the following: IDTFs, mammography centers, portable x-ray facilities and
radiation therapy centers. The rule applies to the technical component of imaging services, and the
professional component will be excluded from the edits. However, if billing globally, both components
will be impacted by the edits and the entire claim will deny if it doesn’t meet the ordering and referring
requirements. It is recommended that providers and suppliers bill the global claims separately to
prevent a denial for the professional component.
Additional Guidance
1. Terminology: Part B claims use the term “ordering/referring provider” to denote the person who
ordered, referred, or certified an item or service reported in that claim. The final rule uses technically
correct terms: 1) a provider “orders” non-physician items or services for the beneficiary, such as DMEPOS,
clinical laboratory services, or imaging services and 2) a provider “certifies” home health services to a
beneficiary. The terms “ordered” “referred” and “certified” are often used interchangeably within the
health care industry. Since it would be cumbersome to be technically correct, CMS will continue to use
the term “ordered/referred” in materials directed to a broad provider audience.
2. Orders or referrals by interns or residents: The IFC mandated that all interns and residents who
order and refer specify the name and NPI of a teaching physician (i.e., the name and NPI of the teaching
physician would have been required on the claim for service(s)). The final rule states that State-licensed
- page 89 -
July 2013
residents may enroll to order and/or refer and may be listed on claims. Claims for covered items and
services from un-licensed interns and residents must still specify the name and NPI of the teaching
physician. However, if States provide provisional licenses or otherwise permit residents to order and
refer services, CMS will allow interns and residents to enroll to order and refer, consistent with State law.
3. Orders or referrals by physicians and non-physician practitioners who are of a type/specialty
that is eligible to order and refer who work for the Department of Veterans Affairs (DVA), the
Public Health Service (PHS), or the Department of Defense (DoD)/Tricare: These physicians and
non-physician practitioners will need to enroll in Medicare in order to continue to order or refer items
or services for Medicare beneficiaries. They may do so by filling out the paper CMS-855O or they may
use Internet-based PECOS. They will not be submitting claims to Medicare for services they furnish to
4. Orders or referrals by dentists: Most dental services are not covered by Medicare; therefore, most
dentists do not enroll in Medicare. Dentists are a specialty that is eligible to order and refer items or
services for Medicare beneficiaries (e.g., to send specimens to a laboratory for testing). To do so, they
must be enrolled in Medicare. They may enroll by filling out the paper CMS-855O or they may use
Internet-based PECOS. They will not be submitting claims to Medicare for services they furnish to
For more information about the Medicare enrollment process, visit http://www.cms.gov/Medicare/ProviderEnrollment-and- Certification/MedicareProviderSupEnroll/index.html or contact the designated Medicare
contractor for your State. Medicare provider enrollment contact information for each State can be found at
http://www.cms.gov/Medicare/Provider-Enrollment-and- Certification/MedicareProviderSupEnroll/downloads/
Contact_list.pdf on the CMS website.
The Medicare Learning Network® (MLN) fact sheet titled, “Medicare Enrollment Guidelines for Ordering/
Referring Provider,” is available at http://www.cms.gov/Outreach-and- Education/Medicare-Learning-Network-MLN/
MLNProducts/downloads/MedEnroll_OrderReferProv_factSheet_ICN906223.pdf on the CMS website.
Note: You must obtain a National Provider Identifier (NPI) prior to enrolling in Medicare. Your NPI is a required
field on your enrollment application. Applying for the NPI is a separate process from
Medicare enrollment. To obtain an NPI, you may apply online at https://nppes.cms.hhs.gov/NPPES/Welcome.do
on the CMS website. For more information about NPI enumeration, visit http://www.cms.gov/Regulations-andGuidance/HIPAA-Administrative- Simplification/NationalProvIdentStand/index.html on the CMS website.
MLN Matters® Article MM7097, “Eligible Physicians and Non-Physician Practitioners Who Need to Enroll
in the Medicare Program for the Sole Purpose of Ordering and Referring Items and Services for Medicare
Beneficiaries,“ is available at http://www.cms.gov/Outreach-and-Education/Medicare- Learning-Network-MLN/
MLNMattersArticles/Downloads/MM7097.pdf on the CMS website.
MLN Matters® Article MM6417, “Expansion of the Current Scope of Editing for Ordering/Referring Providers for
Claims Processed by Medicare Carriers and Part B Medicare Administrative Contractors (MACs),” is available at
http://www.cms.gov/Outreach-and-Education/Medicare-Learning- Network-MLN/MLNMattersArticles/Downloads/
MM6417.pdf on the CMS website.
MLN Matters® Article MM6421, “Expansion of the Current Scope of Editing for Ordering/Referring Providers
for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Suppliers’ Claims Processed by
Durable Medical Equipment Medicare Administrative Contractors (DME MACs),” is available at http://www.cms.
gov/Outreach-and-Education/Medicare-Learning-Network- MLN/MLNMattersArticles/Downloads/MM6421.pdf on
the CMS website;
MLN Matters® Article MM6129, “New Requirement for Ordering/Referring Information on Ambulatory Surgical
Center (ASC) Claims for Diagnostic Services,” is available at http://www.cms.gov/Outreach-and-Education/
Medicare-Learning-Network- MLN/MLNMattersArticles/Downloads/MM6129.pdf on the CMS website.
MLN Matters Article, MM6856, “Expansion of the Current Scope for Attending Physician Providers for freeThis newsletter should be shared with all health care practitioners and managerial members of the provider/supplier staff.
July 2013
- page 90 -
standing and provider-based Home Health Agency (HHA) Claims processed by Medicare Regional Home Health
Intermediaries (RHHIs), is available at http://www.cms.gov/Outreach-and- Education/Medicare-Learning-NetworkMLN/MLNMattersArticles/downloads/MM6856.pdf on the CMS website.
If you have questions, please contact your Medicare Carrier, Part A/B MAC, or DME MAC, at their toll- free
numbers, which may be found at http://www.cms.gov/Research-Statistics-Data-and- Systems/MonitoringPrograms/provider-compliance-interactive-map/index.html on the CMS website.
SE1303 - Information on the National Physician Payment
Transparency Program: Open Payments
News Flash – REVISED products from the Medicare Learning Network® (MLN)
“The Basics of Medicare Enrollment for Physicians and Other Part B Suppliers,” Fact Sheet, ICN 903768,
Downloadable only.
This MLN Matters® Special Edition Article is intended to inform physicians and teaching hospitals of the
National Physician Payment Transparency Program (OPEN PAYMENTS) being implemented by CMS to satisfy
Section 6002 of the Affordable Care Act.
The Centers for Medicare & Medicaid Services (CMS) published, on February 8, 2013, a final rule that is intended
to increase public awareness of financial relationships between manufacturers of drugs, devices, biologicals
and medical supplies, as well as between applicable Group Purchasing Organizations (GPOs), and physicians
and teaching hospitals. Known as the “National Physician Organizations (GPOs), and physicians and teaching
hospitals. Known as the “National Physician Payment Transparency Program: OPEN PAYMENTS,” this is one of
many steps in the Affordable Care Act designed to create greater transparency in the health care market.
Background
On February 8, 2013, CMS published a final rule, titled the “Medicare, Medicaid, Children’s Health Insurance
Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests.” With this
program, applicable manufacturers and applicable GPOs will begin tracking and reporting payments and other
transfers of value made to physicians and teaching hospitals, as well as certain ownership interests held in the
organizations by physicians and their immediate family members. CMS will collect the data annually, aggregate
it, and publish it on a public website as required by the Affordable Care Act.
As noted by Peter Budetti, M.D., Deputy Administrator for Program Integrity of the Centers for Medicare &
Medicaid Services (CMS), US Department of Health and Human Services, and Director of the CMS Center for
Program Integrity in a February 1, 2013, CMS press release: “You should know when your doctor has a financial
relationship with the companies that manufacture or supply the medicines or medical devices you may need.
Disclosure of these relationships allows patients to have more informed discussions with their doctors.”
While financial ties alone do not signify an inappropriate relationship, OPEN PAYMENTS will create public
transparency, which aims to:
• Promote transparent information regarding financial relationships.
• Disclose the nature and extent of financial relationships between the industry and the physicians and
teaching hospitals.
• Discourage inappropriate influences on research, education, and clinical decision-making.
• Curtail potential conflicts of interest that can compromise clinical integrity and patient care.
Final Rule Details
- page 91 -
July 2013
Relevant Definitions
1. Applicable Manufacturers:
Those entities that operate in the United States and (1) are engaged in the production, preparation,
propagation, compounding, or conversion of a covered drug, device, biological, or medical supply,
but not if such covered drug, device, biological or medical supply is solely for use by or within the
entity itself or by the entity’s own patients (this definition does not include distributors or wholesalers
(including, but not limited to, repackagers, relabelers, and kit assemblers) that do not hold title to any
covered drug, device, biological or medical supply); or (2) are entities under common ownership with
an entity described in part (1) of this definition, which provide assistance or support to such entities
with respect to the production, preparation, propagation, compounding, conversion, marketing,
promotion, sale, or distribution of a covered drug, device, biological or medical supply.
2. Applicable GPOs:
Those that operate in the United States and purchase, arrange for purchase, or negotiate the purchase
of a covered drug, device, biological, or medical supply for a group of individuals or organizations that
are not solely using the covered supply.
3. Covered Products:
Any drug and biologic for which payment is available under Medicare, Medicaid or the Children’s
Health Insurance (CHIP) program, either separately (such as through a fee schedule) or as part of a
bundled payment (for example, under the hospital inpatient prospective payment system), and require
a prescription to be dispensed.
Any device or medical supply for which payment is available under Medicare, Medicaid or the
Children’s Health Insurance (CHIP) program, either separately (such as through a fee schedule) or as
part of a bundled payment (for example, under the hospital inpatient prospective payment system
(IPPS)), and require premarket approval by or premarket notification to the U.S. Food and Drug
Administration (FDA).
4. Teaching hospitals:
Hospitals that receive payment for Medicare direct graduate medical education (GME), IPPS indirect
medical education (IME), or psychiatric hospital IME programs.
Implementation Timeline
In order to give applicable manufacturers and applicable GPOs sufficient time to prepare after publication of
the final rule, industry data collection will begin on August 1, 2013. For the 2013 OPEN PAYMENTS program
cycle, it will be abbreviated with only 5 months of data to be collected and reported, as compared to the
12-month cycles in subsequent years (January through December). Then, applicable manufacturers and
applicable GPOs will submit the data to CMS by March 31, 2014, and CMS will make the data publicly available
by September 30, 2014. CMS is developing an electronic system to facilitate the reporting process and the
reported information will be easily aggregated, downloaded, and searchable on the program website.
Industry Data Collection Requirements
The law specifies that, annually:
•
•
•
Applicable manufacturers of covered drugs, devices, biologicals, and medical supplies must report
payments or other transfers of value they make to physicians and teaching hospitals to CMS.
Applicable manufacturers and applicable GPOs must report to CMS ownership or investment interests
held by physicians or their immediate family members. Payments and other transfers of value to these
physicians must also be reported.
Applicable GPOs must report to CMS payments or other transfers of value made to physician owners or
investors if they held ownership or an investment interest at any point during the reporting year.
Reportable payments or other transfers of value include such things as consulting fees, honoraria, gifts,
entertainment, food and beverages, travel and lodging, and other items.
Research Payments
The statute requires applicable manufacturers to report numerous types of payments to physicians and
teaching hospitals, including consulting fees, food and beverages, and research payments. Please note,
however, that research payments, or other transfers of value may be delayed from publication on the website
July 2013
- page 92 -
until the date of FDA approval or up to 4 years from the date of report (whichever is first), when made under
a product research or development agreement in connection with: 1) Research on, or development of, a new
drug, device, biologic, or medical supply, or a new application of an existing drug, device, biologic, or medical
supply; or 2) Clinical investigations regarding a new drug, device, biologic, or medical supply.
Opportunity to Review and Correct Information Prior to Publication
The law requires CMS to provide the physicians and teaching hospitals, who are being reported about, at least
45 days to review and dispute the information related to them that was submitted by applicable manufacturers
and applicable GPOs. The review and correction period starts at least 60 days before the information is made
public each year. Any disputed payments or transfers of value will need to be resolved directly between the
disputer (physician or teaching hospital) and the relevant applicable manufacturer or applicable GPO. After the
45 days, applicable manufacturers and applicable GPOs will have an additional 15 days to submit corrections
based on any disputes identified by physicians, teaching hospitals, and physician owners/investors.
Physicians should maintain their own records of any interaction with applicable manufacturers and applicable
GPOs. This can help facilitate the review of the data that is submitted about them.
CMS will notify the physician and teaching hospital communities when the reported information is ready
for review using an online posting and through notifications via CMS’ listserv, i.e., electronic mailing lists to
which physicians may subscribe including the CMS OPEN PAYMENTS listserv (located at http://go.cms.gov/
openpayments on the CMS website).
Penalties for Failure of Accurate, Complete, and Timely Reporting of Required Information The Affordable
Care Act provides that violators of the reporting requirements will be subject to Civil Monetary Penalties
(CMPs), capped annually at $150,000 for failure to report, and $1,000,000 for known failure to report. These
CMPs only apply to applicable manufacturers and applicable GPOs. CMS finalized that the HHS Office of
Inspector General (OIG) and CMS reserve the right to audit, evaluate, or inspect the records of applicable
manufacturers and applicable GPOs for their compliance with the reporting requirements. In order to facilitate
these inspections, applicable manufacturers and applicable GPOs must maintain all records and documents for
at least five years from the date of payments or other transfers of value or ownership or investment interest is
published publicly on the website.
State Law Preemption
Section 6002 of the Affordable Care Act also preempts any State or local laws requiring reporting of the same
types of information regarding payments or other transfers of value made by applicable manufacturers to
covered recipients. No State or local government may require the separate reporting of any information
regarding a payment or other transfer of value that is required to be reported under this statute; unless such
information is being collected by a Federal, State, or local government agency for public health surveillance,
investigation, or other public health purposes or health oversight.
For more information, please refer to the final rule, CMS-5060-F, “Transparency Reports and Reporting of
Physician Ownership or Investment Interests,” which is available at http://www.gpo.gov/fdsys/pkg/FR-2013-0208/html/2013-02572.htm on the Internet or email questions to [email protected].
There is also a dedicated CMS website for OPEN PAYMENTS, which can be found at
http://go.cms.gov/openpayments on the CMS website.
Also available for physicians to learn more about OPEN PAYMENTS is a continuing medical education (CME)
activity, “Are You Ready for the National Physician Payment Transparency Program?” Accessible via MedScape,
and accredited by the Accreditation Council for Continuing Medical Education, physicians can receive a
maximum of 1.00 AMA PRA Category 1 Credit™ by participating in the activity and receiving a minimum score
of 70% on the post-test. Through the activity, participants will learn more about OPEN PAYMENTS, the steps
involved in collecting and reporting physician data, key dates for implementation, and actions they can take to
verify physician information in advance of website publication.
- page 93 -
July 2013
Spiracur SNaP Wound Care System
CGS will reimburse SNaP effective for dates of service on and after January 1, 2013. SNaP is a process that
combines a suction device with an advanced hydrocolloid wound dressing to deliver constant and controlled
levels of negative pressure to facilitate the healing of the following types of open wounds:
• Stage III and IV pressure ulcer
• Neuropathic (diabetic) ulcer
• Chronic (present for at least 30 days) ulcer of mixed etiology
• Venous or arterial insufficiency ulcer
• Complications of a surgically created wound
• Traumatic wound
Providers should utilize all accepted wound care standards prior to using SNaP. Accepted wound care standards
include, but are not limited to, the following:
 Patient turning and positioning
 Appropriate surface modalities to prevent pressure wounds
 Appropriate management of moisture and incontinence
 Consistent application of compression garments and/or bandages
 Leg elevation and ambulation
 Appropriate topical wound treatments
 Appropriate necrotic tissue debridement
 Nutritional status evaluation with appropriate intervention
You may submit an Evaluation & Management (E/M) service with SNaP only when a separately identifiable
service is performed in addition to the negative pressure wound therapy. Supporting documentation is
required in the patient’s medical record. Submit these E/M services with CPT modifier 25. Please note that a
simple check of the wound does not justify an additional E/M service and will be denied as not being medically
necessary.
The patient medical records should contain:
• Physician’s signed order/intent to order the treatment
• Documentation to substantiate standard protocols have been met
• Wound description, including specific measurements and condition
• Patient-specific treatment plan
• Changes in patient status
HCPCS codes:
• G0456 (Negative pressure wound therapy, (e.g. vacuum assisted drainage collection) using a
mechanically-powered device, not durable medical equipment, including provision of cartridge and
dressing(s) topical application(s) wound assessment, and instructions for ongoing care, per session;
total wound(s) surface area less than or equal to 50 square centimeters) , or
• G0457 (Negative pressure wound therapy, (e.g. vacuum assisted drainage collection) using a
mechanically-powered device, not durable medical equipment, including provision of cartridge and
dressing(s) topical application(s) wound assessment, and instructions for ongoing care, per session;
total wound(s) surface area greater than 50 square centimeters)
• Enter ‘Spiracur SNaP device’ in the electronic documentation field (Loop 2400, NTE02, or SV101-7
field), or in item 19 if you are approved to submit paper claims . If an equivalent product is being
used that meets the same specifications as the Spiracur SNaP Wound Care System, enter that product
name in this location.
July 2013
- page 94 -
Local Coverage Determination (LCD): Application of Cellular and/
or Tissue Based Products (CTPs) for Wounds of Lower Extremities
(L33173)
Contractor Information
Contractor Name
CGS Administrators, LLC opens in new window
Contract Number
15102
Contract Type
MAC - Part B
LCD Information
Document Information
LCD ID L33173
LCD Title
Application of Cellular and/or Tissue Based Products
(CTPs) for Wounds of Lower Extremities
AMA CPT/ADA CDT Copyright Statement
CPT only copyright 2002-2012 American Medical Association. All Rights Reserved. CPT is a registered trademark
of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative
value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and
the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense
medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental
Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American
Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.
Jurisdiction opens in new window
Kentucky
Original Effective Date
For services performed on or after 05/01/2013
Revision Effective Date
N/A
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date N/A Notice Period End Date N/A
CMS National Coverage Policy
This LCD supplements but does not replace, modify, or supercede existing Medicare applicable National
Coverage
Determinations (NCDs) or payment policy rules and regulations for cellular and/or tissue based products (CTPs).
Unless otherwise specified, italized text represents quotation from one or more of the following CMS sources:
- page 95 -
July 2013
Title XVIII of the Social Security Act:
Section 1862(a)(1)(A) allows coverage and payment for only those services that are considered to be medically
reasonable and necessary.
Section 1833(e). This section prohibits Medicare payment for any claim that lacks the necessary information to
process the claim.
CMS Internet Only Manual(IOM)Publication:
IOM Medicare Benefit Policy Manual Pub 100-02, Chapter 15, Sections 190, 200, and 210
IOM Medicare Claims Processing Manual Pub 100-04, Chapter 17, Sections 20 and 40
IOM Medicare Program Integrity Manual Pub 100-80, Chapter 13, Section 13.1.3
Coverage Guidance
Coverage Indications, Limitations, and/or Medical Necessity
The provisions of this LCD apply to the use of CTPs in the treatment of lower extremity ulcer disease (i.e.
neuropathic diabetic foot ulcer, venous stasis ulcers) and the physician services reported for preparation and
material application of lower extremities ulcers. CTPs (i.e., human skin equivalents, dermal substitute tissues)
are products that use living cells (e.g.fibroblasts and keratinocytes) or other collagen-derived or biologicallyderived extracellular matrix in a scaffold of natural, biodegradable, or synthetic matrices to foster wound
healing. This provides a stable framework that guides tissue integration and development as well as to bind
autologous proteins which influence cell migration and adherence.
This LCD does not address human skin autografts, cadaveric human skin allografts, or porcine dermal
xenografts. Additionally, the provisions of this LCD do not apply to treatment of acute postoperative wounds,
deep tissue reconstruction and/or replacements (e.g. tendon and/or ligament augmentation/repair, breast
reconstruction, abdominal hernia repair) or burns.
CGS Administrators(CGS) will consider all skin substitute products regulated as Class II or Class III devices as well
as those products regulated as Human Cells, Tissues, Cellular, and Tissue-Based Products (HCT/Ps) (described
in 21 CFR 1271.10) eligible for coverage based upon adequate clinical trial literature that clearly supports their
use in wound care therapy. With that in mind, we have determined to cover those which we are satisfied have
achieved at least a threshold minimum of literature supporting their efficacy.
Additionally, the provisions of this LCD do not apply to treatment of acute postoperative wounds, deep tissue
reconstruction and/or replacements (e.g. tendon and/or ligament augmentation/repair, breast reconstruction,
abdominal hernia repair) or burns.
Indications:
Application of CTPs for the treatment of lower extremity (LE) ulcers will be covered when the following
conditions are met and documented as appropriate for the individual patient:
• Presence of diabetic foot ulcers that have failed to respond to documented conservative wound-care
measures of greater than four weeks.
• Presence of venous stasis ulcers that have failed to respond to documented conservative wound-care
measures of greater than four weeks.
Note: For purposes of this LCD, conservative measures include, but are not limited to:
• Elimination of edema
• Elimination of underlying cellulitis, active treatment of osteomyelitis, or other infection
• Appropriate debridement of necrotic tissue
• For diabetic foot ulcers appropriate non-weight bearing and/or off-loading pressure
• For venous stasis ulcers standard compression therapy
• Provision of appropriate wound environment to promote healing
Note: Documentation must indicate that these conditions have been successfully treated and resolved prior to
CTP treatment.
July 2013
- page 96 -
•
•
•
•
•
•
Applied to ulcers that have failed to respond to conservative wound-care measures. “ Failed response”
is defined as an ulcer that has increased in size or depth, or no change in baseline size or depth and no
sign of improvement or indication that improvement is likely (such as granulation, epithelialization, or
progress towards closing). Documentation of response requires measurements of the initial ulcer, at
the completion of at least four weeks of conservative wound-care measures and immediately prior to
placement of the skin substitute.
Presence of partial and full-thickness ulcers, joint capsule, or exhibiting exposed bone or sinus tracts.
Wounds are clean and free of infection
Only apply CTPs to wounds with adequate circulation/oxygenation to support tissue growth/wound
healing as evidenced by physical examination (presence of acceptable peripheral pulses and/or AnkleBrachial Index (ABI)of no less than 0.65).
For diabetic foot ulcers the patient’s medical record should reflect a diagnosis of Type 1 or Type 2
diabetes and reflect medical management for this condition
CTPs must be provided in accordance with the Food and Drug Administration (FDA) approved package label
Documentation requirements to support coverage and/or medical necessity:
The medical records should contain documentation found under the indications and limitations of coverage
and/or medical necessity, as well as, appropriate diagnosis and response to treatment. Description of the
wound should be documented at baseline (prior to beginning conservative treatment), size, location, stage,
duration, and presence of infection. Documentation should also contain the type of treatment given and
patient’s response. This information must be updated throughout treatment with the wound description
documented pre and post treatment with the CTP being used. If the wound shows signs of worsening or lack of
treatment response is noted, continuing treatment with the CTP would not be considered medically reasonable
and necessary without documenting a reasonable rationale for doing so.
Since application of Apligraf®, OASIS® Wound Matrix, OASIS® Ultra Tri-Layer Matrix, and Dermagraft®, as well
as any subsequently-accepted similar product is considered a physician service, it must be applied by either a
physician or a nonphysician practitioner (NPP), and NOT by non-advanced practice nurses, therapists or medical
assistants.
In addition documentation must verify the ulcer/wound must be free of infection and/or underlying
osteomyelitis, prior to instituting CTP treatment.
The expectation is that the product itself will function as a permanent replacement for the lost or
damaged skin, or as a facilitator for the development and/or ingrowth of the patient’s skin.
Limitations of coverage are as follows:
• Timing, frequency, and number of reapplications of CTPs should be appropriate for the material used
and clinical condition of the patient. Medicare does not expect to see routine application of maximally
allowed numbers of skin substitutes/replacements per wound and will monitor and evaluate claim data
regarding numbers of applications per patient and per wound.
• During a course of treatment, repeat applications of CTPs is not considered medically reasonable and
necessary when previous applications was unsuccessful. Unsuccessful treatment is defined in this
situation as increase in size or depth of a wound or ulcer, or no change in baseline size or depth and no
sign of improvement or indication that improvement is likely (such as granulation or epithelialization
and no progress toward closing) since the previous application.
• Retreatment of healed ulcers is not considered medically reasonable and necessary. Retreating the
wound with the same CTP product is not indicated for ulcers for which an initial course of treatment
with the same CTP was unsuccessful. An unsuccessful course of treatment is defined in this case as
incomplete
• healing following maximal numbers of applications and/or maximal duration of treatment time
indicated by
• the FDA label of the individual product and/or this LCD.
• CTPs are contraindicated in patients with inadequate control of underlying conditions or exacerbating
factors, or other contraindication (e.g., uncontrolled diabetes, active infection, active charcot
arthropathy of the ulcer extremity, and/or vasculitis)
• Skin substitutes are contraindicated in patients with known hypersensitivity to any component of the
- page 97 -
July 2013
•
•
•
•
•
•
•
specific skin substitute (e.g, allergy to bovine)
In vitro and in vivo histology studies have shown that Apligraf® either degrades or its cell viability is
reduced when the device is exposed to the following cytotoxic agents: Dakin’s solution, Mafenide
acetate, Scarlet red dressing, Tincoban, Zinc sulfate, Povodine-iodine solution, Chlorhexidine, or
Polymixin/Nystatin. The use of Apligraf® with these solutions will be considered not medically
reasonable and necessary, and will result in denial of reimbursement.
Any topical agents, cytotoxic cleansing solutions, or medications (e.g., lotions, ointments, creams, or
gels) on an ulcer being treated with Dermagraft® may reduce the viability of the product. The use of
Dermagraft® in conjunction with these solutions will be considered not reasonable and necessary and
will result in denial of reimbursement.
Treatment of any ulcer will typically last no more than twelve weeks.
For venous stasis ulcers, if after twelve weeks of compression treatment and the appropriate number
of applications of the CTP, a 50 percent or greater improvement is noted and documented, then one or
more subsequent re-applications of the CTP will be considered for Medicare coverage. Otherwise, reapplication of the CTP is not recommended and will not be reimbursed and other treatment modalities
should be considered.
Re-treatment within one year of completion of any given course of skin substitute for venous stasis
ulcers is not covered.
For diabetic foot ulcers, if after nine weeks of treatment, and three applications of the CTP, satisfactory
healing progress is not noted, then re-application of the CTP is not recommended and other treatment
modalities must be considered.
Coverage will not be provided under this LCD for any wound treatment that does not meet the
definition of Q4101, Q4102, Q4106, Q4107, Q4110 or Q4121, Q4124. All other such products, will be
considered at most, “biologic wound dressings” which are included in the Evaluation and Management
(E&M) service and should not be billed separately.
Note: The following modifiers were effective for dates of service on or after 01/01/2009:
• JC- skin substitute used as a graft
• JD -Skin substitute not used as a graft
Providers should use the above modifiers in compliance with CPT ® and CMS instructions.
• Consistent with FDA product labeling which limits the use of the CTPs(Q4101, Q4102, Q4106, Q4107,
Q4110, Q4121, Q4124) to clean wounds thus requiring at most minimal debridement, CPT codes 15002
through 15005 are not appropriate. The minimal wound preparation described by these codes is part
of the application procedure code, as clearly included in the procedure CPT description. To emphasize
this point: The CPT Manual introductory comments to the “Skin Replacement Surgery” chapter in the
paragraph starting with “Skin Substitutes grafts” reconfirms this position, “Removal of current graft
and/or simple cleansing of wound is included, when performed. Do not report 97602. Debridement is
considered a separate procedure only when gross contamination requires prolonged cleansing when
appreciable amounts of devitalized or contaminated tissue are removed, or when debridement is
carried out separately without immediate primary closure.”
• The medical record documentation must clearly support that any amount of debridement was
medically reasonable and necessary. Literature clearly demonstrates that development on as often as a
weekly basis of necrosis significant enough to warrant debridement strongly suggests that vascularity is
insufficient to allow wound healing, even with the use of skin substitute therapy.
CGS considers the CPT debridement codes to be appropriate for use only by Physicians or NPPs (with the
exception of the Physical Therapy debridement codes). Billing for “debridement” performed during routine
dressing changes in the course of treatments as contemplated in this LCD is not appropriate. Debridement
carried out by a Physical Therapist must be done within a Plan of Care authorized and closely supervised by the
treating Physician.
Compliance with the provisions in this policy is subject to monitoring by active and ongoing pre and post
payment data analysis and subsequent medical review.
Note: Medicare may make payment only for those services performed by persons with appropriate education,
knowledge, skill and competence. Medicare may make payment for physician services performed by persons
licensed by the state to perform them. Because applications of Apligraf®, Oasis®, GraftJacket® and Dermagraft®,
July 2013
- page 98 -
as well as any subsequently accepted similar product, are physician (surgical) services, Medicare payment
for the products and their applications will be made only to licensed physicians and qualified non- physician
practitioners who are licensed to perform these physician services (nurse practitioners, clinical nurse specialists
and physician assistants).
The following indications and limitations to Medicare coverage and payment apply to the following
specified covered CTPS and their related CTP application physician services.
Apligraf® (Q4101) Indications:
•Full-thickness diabetic foot ulcer.
•Partial and/or full-Venous stasis ulcer.
Apligraf® (Q4101) Limitations:
• Apligraf® is limited to five applications per ulcer, though more than three applications of Apligraf®
to a single wound are usually unnecessary.
• Retreatment of an ulcer following an unsuccessful course of treatment is not covered.
Oasis Wound Matrix® and Oasis®Ultra Tri-Layer Matrix ® (Q4102; Q4124) Indications:
• Partial and full-thickness diabetic foot ulcer.
• Partial and full-thickness venous stasis ulcer.
Oasis® (Q4102; Q4124) Limitations:
• Oasis® is limited to 12 weeks of therapy per ulcer.
Dermagraft® (Q4106) Indications:
• Full-thickness diabetic foot ulcers.
Dermagraft® (Q4106) Limitations:
• Studies have documented that, for Q4106, survival of the dermal substitute decreases significantly
when the 24 steps noted in the FDA labeling are not followed, therefore the 24 steps must be followed
and documented.
• Frequency is limited to eight applications per ulcer over a twelve week period.
• Reapplication of Dermagraft® for the same ulcer if satisfactory and reasonable healing progress is not
noted after 12 weeks of therapy.
• Retreatment of the same ulcer using Dermagraft® following an unsuccessful course of treatment is not
covered.
GraftJacket® (Q4107) Indications:
• Full-thickness diabetic foot ulcers
• Patient does not have a current HbA1C reading exceeding 12%
• Underlying disease process(es) contributing to the ulcer, e.g., diabetes, is adequately treated and
documented; and
• Ulcers located on the foot or toes and are free of infection, redness, drainage, underlying osteomyelitis,
surrounding cellulitis, tunnels or tracts, eschar or any necrotic material that could interfere with the
adherence of GRAFTJACKET® and the process of wound healing.
GraftJacket® (Q4107) Limitations:
• GraftJacket® is limited to a maximum of 2 applications for any ulcer that initially qualifies for treatment.
• Usually 1 application is all that is needed in most cases.
PriMatrix® (Q4110) Indications:
• Partial and full-thickness wounds
PriMatrix® (Q4110) Limitations:
• Adequate arterial blood supply as evidenced by ankle-brachial index (ABI) of 0.65 or greater in limb
undergoing the procedure
• Full thickness ulcers of at least 3 weeks in duration and which extend through dermis
- page 99 -
July 2013
•
Retreatment of the same ulcer using PriMatrix ® following an unsuccessful course of treatment is not
covered.
Theraskin® (Q4121) Indications:
• Ulcers located on feet and toes
• Free of infection, redness, drainage, underlying osteomyelitis, surrounding cellulitis, tunnels and tracts,
eschar or any necrotic material.
Theraskin® (Q4121) Limitations:
• Adequate arterial blood supply as evidenced by ankle-brachial index (ABI) of 0.65 or greater in limb
undergoing the procedure
• Full thickness ulcers of at least 3 weeks in duration and which extend through dermis
• Retreatment of the same ulcer using Theraskin ® following an unsuccessful course of treatment is not
covered.
Additional Requirements
For both VSUs and DFUs all of the following must also be satisfied and documented:
•
•
•
•
•
•
•
•
•
Treatment must be used in conjunction with following standard conservative measures:
Use of pressure-reducing footwear;
A non-weight bearing regiment;
Debridement of necrotic and callused tissue when necessary; and
Acceptable methods of wound care, such as saline moistened dressings
The patient must be competent and/or have the support system required to participate in follow-up
care associated with treatment of the wound.
Only when adequate treatment of the underlying disease process(es) contributing to the ulcer (for
example, diabetes) is provided and documented in conjunction with treatment.
Only for wounds of the lower extremity that are documented to be free of infection, redness, significant
drainage, underlying osteomyelitis, surrounding cellulitis, tunnels and/or tracks, eschar or necrotic
material that could interfere with the adherence of the treatment device and the process of wound
healing.
For diabetic foot ulcers (DFU), documentation in the medical record must confirm that the patient has
either Type I or Type II diabetes mellitus.
Utilization Guidelines
A single application of a CTP for any particular ulcer is usually all that is required to affect wound healing in
those wounds that are likely to be helped by this therapy. More than three applications to a single wound are
usually not expected.
Four or more applications of a CTP could result in a medical review for determination of medical necessity.
The safety and effectiveness of Apligraf® have not been established for patients receiving more than five
device applications. The use of more than five applications for the same ulcer is not considered reasonable and
necessary.
The use of Dermagraft® is limited to no more than 8 applications per treatment site over a 12 week period. The
use of more than 8 applications for the same ulcer is not considered reasonable and necessary.
Oasis® is limited to12 weeks of treatment per ulcer.
Providers may request that a product be approved for use by submitting a request in writing and including the
data supporting its use. The request should include the types of intervention for which a product is intended (e.g.,
venous stasis ulcer, diabetic foot ulcer, pressure ulcer, burn sites, hernias, and reconstruction and donor sites).
Because wounds differ in their pathophysiology, it is difficult to generalize results obtained from a trial
conducted in subjects with one wound type to patients with another wound type. Therefore, separate
supporting evidence should be submitted for each type of wound coverage sought. However, if a scientific
rationale and clinical data support clinical activity of a product in more than one wound type, it may be possible
July 2013
- page 100 -
for the contractor to consider studies performed in one wound type to support another in establishing
substantial evidence of efficacy and safety.
The data must include:
1. A use supported by clinical research that appears in at least two well designed and executed clinical trials
that definitively demonstrate safety and effectiveness; the trials must come from different centers and be
published in national or international peer-reviewed (editorial committee is comprised of physicians) journals.
Peer-reviewed medical literature includes scientific and medical publications; it does not include in-house
publications of manufacturing companies or abstracts (including meeting abstracts).
Or;
2. A use that is an accepted standard of medical practice. (For example, a state of the art review article
published in a recognized textbook or a reputable publication or published recommendations from specialty
societies.) It should be noted that acceptance by individual health care practitioners, or even a limited group
of health care practitioners normally does not indicate general acceptance by the medical community.
Testimonials indicating such limited acceptance, and limited case studies distributed by sponsors with potential
financial conflict of interest in the outcome, are not sufficient evidence of general acceptance by the medical
community. The broad range of available evidence must be considered and its quality must be evaluated
before a conclusion is reached. After such evidence is received, the contractor will, with appropriate help of
specialty-specific consultants as indicated, make a coverage determination for the indication of the product.
A product’s use is based on substantial evidence and is reflective of the safety and efficacy of the product as
determined in clinical investigations.
The contractor may determine a product use to be reasonable and necessary for the treatment of wounds or
other conditions if, on the basis of available or presented evidence, it is shown to be safe and effective and does
not violate national or local Medicare determinations and regulations. The approval will be limited to specific
indications and/or patient populations, practitioner categories, procedures, and/or place of service.
Compliance with the provisions in this policy is subject to monitoring by active and ongoing pre and post
payment data analysis and subsequent medical review.
Coding Information
Bill Type Codes:
Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service.
Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of
all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply
equally to all claims.
N/A
Revenue Codes:
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to
report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services
reported under other Revenue Codes are equally subject to this coverage determination. Complete absence
of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be
assumed to apply equally to all Revenue Codes.
99999 Not Applicable
CPT/HCPCS Codes
Group 1 Paragraph: NON-COVERED PROCEDURES: Those procedures which are either not separately payable
under the terms of this LCD on lower extremity ulcers or not appropriately used with the covered CTPs as
described by by Q4101, Q4102, Q4106, Q4107, Q4110, Q4121 and Q4124.
- page 101 -
July 2013
Group 1 Codes:
15002
SURGICAL PREPARATION OR CREATION OF RECIPIENT SITE BY EXCISION OF OPEN WOUNDS, BURN ESCHAR, OR
SCAR (INCLUDING SUBCUTANEOUS TISSUES), OR INCISIONAL RELEASE OF SCAR CONTRACTURE, TRUNK, ARMS,
LEGS; FIRST 100 SQ CM OR 1% OF BODY AREA OF INFANTS AND CHILDREN
15003
SCAR (INCLUDING SUBCUTANEOUS TISSUES), OR INCISIONAL RELEASE OF SCAR CONTRACTURE, TRUNK, ARMS,
LEGS; EACH ADDITIONAL 100 SQ CM, OR PART THEREOF, OR EACH ADDITIONAL 1% OF BODY AREA OF INFANTS
AND CHILDREN (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
SURGICAL PREPARATION OR CREATION OF RECIPIENT SITE BY EXCISION OF OPEN WOUNDS, BURN
15004
ESCHAR, OR SCAR (INCLUDING SUBCUTANEOUS TISSUES), OR INCISIONAL RELEASE OF SCAR CONTRACTURE,
FACE, SCALP, EYELIDS, MOUTH, NECK, EARS, ORBITS, GENITALIA, HANDS, FEET
AND/OR MULTIPLE DIGITS; FIRST 100 SQ CM OR 1% OF BODY AREA OF INFANTS AND CHILDREN
SCAR (INCLUDING SUBCUTANEOUS TISSUES), OR INCISIONAL RELEASE OF SCAR
15005
CONTRACTURE, FACE, SCALP, EYELIDS, MOUTH, NECK, EARS, ORBITS, GENITALIA, HANDS, FEET AND/OR
MULTIPLE DIGITS; EACH ADDITIONAL 100 SQ CM, OR PART THEREOF, OR EACH ADDITIONAL 1% OF BODY AREA
OF INFANTS AND CHILDREN (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
Group 2 Paragraph: NON-COVERED PRODUCTS: The following products are considered to be wound
dressings and not separately payable as CTPs.
Group 2 Codes:
Q4100 SKIN SUBSTITUTE, NOT OTHERWISE SPECIFIED
Q4104 INTEGRA BILAYER MATRIX WOUND DRESSING (BMWD), PER SQUARE CENTIMETER Q4105 INTEGRA
DERMAL REGENERATION TEMPLATE (DRT), PER SQUARE CENTIMETER Q4108 INTEGRA MATRIX, PER SQUARE
CENTIMETER
Q4111 GAMMAGRAFT, PER SQUARE CENTIMETER Q4112 CYMETRA, INJECTABLE, 1CC
Q4113 GRAFTJACKET XPRESS, INJECTABLE, 1CC
Q4114 INTEGRA FLOWABLE WOUND MATRIX, INJECTABLE, 1CC Q4115 ALLOSKIN, PER SQUARE CENTIMETER
Q4116 ALLODERM, PER SQUARE CENTIMETER
Q4117 HYALOMATRIX, PER SQUARE CENTIMETER
Q4118 MATRISTEM MICROMATRIX, 1 MG
Q4119 MATRISTEM WOUND MATRIX, PSMX, RS, OR PSM, PER SQUARE CENTIMETER Q4120 MATRISTEM BURN
MATRIX, PER SQUARE CENTIMETER
Q4122 DERMACELL, PER SQUARE CENTIMETER Q4123 ALLOSKIN RT, PER SQUARE CENTIMETER Q4125
ARTHROFLEX, PER SQUARE CENTIMETER
Q4126 MEMODERM, DERMASPAN, TRANZGRAFT OR INTEGUPLY, PER SQUARE CENTIMETER Q4127 TALYMED, PER
SQUARE CENTIMETER
Q4128 FLEX HD, ALLOPATCH HD, OR MATRIX HD, PER SQUARE CENTIMETER Q4129 UNITE BIOMATRIX, PER
SQUARE CENTIMETER
Q4130 STRATTICE TM, PER SQUARE CENTIMETER Q4131 EPIFIX, PER SQUARE CENTIMETER
Q4132 GRAFIX CORE, PER SQUARE CENTIMETER
Q4133 GRAFIX PRIME, PER SQUARE CENTIMETER Q4134 HMATRIX, PER SQUARE CENTIMETER Q4135 MEDISKIN,
PER SQUARE CENTIMETER Q4136 EZ-DERM, PER SQUARE CENTIMETER
Group 3 Paragraph: COVERED PRODUCTS Group 3 Codes:
Q4101 APLIGRAF, PER SQUARE CENTIMETER
Q4102 OASIS WOUND MATRIX, PER SQUARE CENTIMETER Q4106 DERMAGRAFT, PER SQUARE CENTIMETER
Q4107 GRAFTJACKET, PER SQUARE CENTIMETER
Q4110 PRIMATRIX, PER SQUARE CENTIMETER Q4121 THERASKIN, PER SQUARE CENTIMETER
Q4124 OASIS ULTRA TRI-LAYER WOUND MATRIX, PER SQUARE CENTIMETER
Group 4 Paragraph: COVERED APPLICATON PROCEDURES: Apligraf® Oasis® Dermagraft® PriMatrixs
& TheraSkin®
July 2013
- page 102 -
Note: Correct claims’ coding requires THREE (or four) codes (product code, application code and one or two
diagnosis codes).
For the products designated by HCPCS codes Q4101, Q4102, Q4106, Q4107, Q4110, Q4121 and Q4124 use one
of the application codes in the list below (15271-15278) and the appropriate ICD-9-CM code(s) listed below.
Group 4 Codes:
Group 4 Codes:
15271
APPLICATION OF SKIN SUBSTITUTE GRAFT TO TRUNK, ARMS, LEGS, TOTAL WOUND SURFACE AREA UP TO 100
SQ CM; FIRST 25 SQ CM OR LESS WOUND SURFACE AREA
APPLICATION OF SKIN SUBSTITUTE GRAFT TO TRUNK, ARMS, LEGS, TOTAL WOUND SURFACE AREA UP
15272
TO 100 SQ CM; EACH ADDITIONAL 25 SQ CM WOUND SURFACE AREA, OR PART THEREOF (LIST SEPARATELY IN
ADDITION TO CODE FOR PRIMARY PROCEDURE)
APPLICATION OF SKIN SUBSTITUTE GRAFT TO TRUNK, ARMS, LEGS, TOTAL WOUND SURFACE AREA
15273
GREATER THAN OR EQUAL TO 100 SQ CM; FIRST 100 SQ CM WOUND SURFACE AREA, OR 1% OF BODY AREA OF
INFANTS AND CHILDREN
APPLICATION OF SKIN SUBSTITUTE GRAFT TO TRUNK, ARMS, LEGS, TOTAL WOUND SURFACE AREA
15274
GREATER THAN OR EQUAL TO 100 SQ CM; EACH ADDITIONAL 100 SQ CM WOUND SURFACE AREA, OR PART
THEREOF, OR EACH ADDITIONAL 1% OF BODY AREA OF INFANTS AND CHILDREN, OR PART THEREOF (LIST
SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) APPLICATION OF SKIN SUBSTITUTE GRAFT TO
FACE, SCALP, EYELIDS, MOUTH, NECK, EARS, ORBITS,
15275
GENITALIA, HANDS, FEET, AND/OR MULTIPLE DIGITS, TOTAL WOUND SURFACE AREA UP TO 100 SQ CM; FIRST
25 SQ CM OR LESS WOUND SURFACE AREA APPLICATION OF SKIN SUBSTITUTE GRAFT TO FACE, SCALP, EYELIDS,
MOUTH, NECK, EARS, ORBITS,
15276
GENITALIA, HANDS, FEET, AND/OR MULTIPLE DIGITS, TOTAL WOUND SURFACE AREA UP TO 100 SQ CM; EACH
ADDITIONAL 25 SQ CM WOUND SURFACE AREA, OR PART THEREOF (LIST SEPARATELY IN ADDITION TO CODE
FOR PRIMARY PROCEDURE) APPLICATION OF SKIN SUBSTITUTE GRAFT TO FACE, SCALP, EYELIDS, MOUTH, NECK,
EARS, ORBITS,
15277
GENITALIA, HANDS, FEET, AND/OR MULTIPLE DIGITS, TOTAL WOUND SURFACE AREA GREATER THAN OR EQUAL
TO 100 SQ CM; FIRST 100 SQ CM WOUND SURFACE AREA, OR 1% OF BODY AREA OF INFANTS AND CHILDREN
15278 APPLICATION OF SKIN SUBSTITUTE GRAFT TO FACE, SCALP, EYELIDS, MOUTH, NECK, EARS, ORBITS,
GENITALIA, HANDS, FEET, AND/OR MULTIPLE DIGITS, TOTAL WOUND SURFACE AREA GREATER THAN OR
EQUAL TO 100 SQ CM; EACH ADDITIONAL 100 SQ CM WOUND SURFACE AREA, OR PART THEREOF, OR EACH
ADDITIONAL 1% OF BODY AREA OF INFANTS AND CHILDREN, OR PART THEREOF (LIST SEPARATELY IN ADDITION
TO CODE FOR PRIMARY PROCEDURE)
Group 1 Paragraph: Note: Diagnosis codes are based on the current ICD-9-CM codes that are effective at the
time of LCD publication. Any updates to ICD-9-CM codes will be reviewed by CGS, and coverage should not be
presumed until the results of such review have been published/posted.
These are the only ICD-9-CM codes that support medical necessity:
Note: For the products covered by this LCD, use the appropriate ICD-9-CM code(s) that applies to both
the appropriate product (designated by Q4101, Q4102, Q4106, Q4107, Q4110, Q4121, Q4124) and the CPT
application code (15271, 15272, 15273, 15274, 15275, 15276, 15277, and 15278).
Note: Diagnosis criteria do not apply to the following CPT/HCPCS codes: 15002, 15003, 15004, and 15005,
Q4100, Q4104, Q4105, Q4108, Q4111, Q4112, Q4113, Q4114, Q4115, Q4116, Q4117, Q4118, Q4119, Q4120,
Q4122, Q4123, Q4125, Q4126, Q4127, Q4128, Q4129 Q4130, Q4131, Q4132, Q4133, Q4134, Q4135 and Q4136.
- page 103 -
July 2013
These codes are either not separately payable under the terms of this LCD on Lower Extremity Ulcers or not
applicable to the LCD (inappropriate for use with the covered skin substitute products).
These codes are listed for information only, as their use is not payable under this LCD, nor is appropriate use in
such areas as burn and trauma care intended to be governed by the limitations in this LCD.
Group 1
For 15271, 15272, 15273, 15274, 15275, 15276, 15277, and 15278:
The following ICD-9-CM codes may be used alone:
Group 1 Codes:
454.0VARICOSE VEINS OF LOWER EXTREMITIES WITH ULCER
454.2
VARICOSE VEINS OF LOWER EXTREMITIES WITH ULCER AND INFLAMMATION
757.39* OTHER SPECIFIED CONGENITAL ANOMALIES OF SKIN
Group 1 Medical Necessity ICD-9 Codes Asterisk Explanation: **ICD-9-CM code 757.39 may be used only for
epidermolysis bullosa
For 15271, 15272, 15273, 15274, 15275, 15276, 15277, and 15278:
The following ICD-9-CM codes must be used in pairs, i.e., one primary diagnosis and one secondary
diagnosis.
Primary diagnoses
Group 2 Codes:
707.10* UNSPECIFIED ULCER OF LOWER LIMB
707.11* ULCER OF THIGH
707.12* ULCER OF CALF
707.13* ULCER OF ANKLE
707.14* ULCER OF HEEL AND MIDFOOT
707.15* ULCER OF OTHER PART OF FOOT
707.19* ULCER OF OTHER PART OF LOWER LIMB
Group 2 Medical Necessity ICD-9 Codes Asterisk Explanation: **Consistent with FDA labeling, under the
terms of this LCD, CGS’ intent is for the use of this product to lower limb ulcers caused by varicose veins or
diabetes. When billing for ulcers caused by diabetes or using the non-specific venous insufficiency code,
459.81, the provider must use both a code from the diabetes range (249.00-250.83) or 459.81 and a code
from the ulcer of lower limb range (707.10-707.19).
For 15271, 15272, 15273, 15274, 15275, 15276, 15277, and 15278:
Secondary diagnoses:
Group 3 Codes:
249.00*
SECONDARY DIABETES MELLITUS WITHOUT MENTION OF COMPLICATION, NOT STATED AS
UNCONTROLLED, OR UNSPECIFIED
249.01*
SECONDARY DIABETES MELLITUS WITHOUT MENTION OF COMPLICATION, UNCONTROLLED
249.10* SECONDARY DIABETES MELLITUS WITH KETOACIDOSIS, NOT STATED AS UNCONTROLLED, OR
UNSPECIFIED
249.11*
July 2013
- page 104 -
SECONDARY DIABETES MELLITUS WITH KETOACIDOSIS, UNCONTROLLED
249.20*
SECONDARY DIABETES MELLITUS WITH HYPEROSMOLARITY, NOT STATED AS UNCONTROLLED, OR UNSPECIFIED
249.21*
SECONDARY DIABETES MELLITUS WITH HYPEROSMOLARITY, UNCONTROLLED
249.30*
SECONDARY DIABETES MELLITUS WITH OTHER COMA, NOT STATED AS UNCONTROLLED, OR UNSPECIFIED
249.31*
SECONDARY DIABETES MELLITUS WITH OTHER COMA, UNCONTROLLED
249.40*
SECONDARY DIABETES MELLITUS WITH RENAL MANIFESTATIONS, NOT STATED AS UNCONTROLLED, OR
UNSPECIFIED
249.41*
SECONDARY DIABETES MELLITUS WITH RENAL MANIFESTATIONS, UNCONTROLLED
249.50*
SECONDARY DIABETES MELLITUS WITH OPHTHALMIC MANIFESTATIONS, NOT STATED AS UNCONTROLLED, OR
UNSPECIFIED
249.51*
SECONDARY DIABETES MELLITUS WITH OPHTHALMIC MANIFESTATIONS, UNCONTROLLED
249.60*
SECONDARY DIABETES MELLITUS WITH NEUROLOGICAL MANIFESTATIONS, NOT STATED AS UNCONTROLLED,
OR UNSPECIFIED
249.61*
SECONDARY DIABETES MELLITUS WITH NEUROLOGICAL MANIFESTATIONS, UNCONTROLLED
249.70*
SECONDARY DIABETES MELLITUS WITH PERIPHERAL CIRCULATORY DISORDERS, NOT STATED AS
249.71*
SECONDARY DIABETES MELLITUS WITH PERIPHERAL CIRCULATORY DISORDERS, UNCONTROLLED
249.80*
SECONDARY DIABETES MELLITUS WITH OTHER SPECIFIED MANIFESTATIONS, NOT STATED AS
249.81*
SECONDARY DIABETES MELLITUS WITH OTHER SPECIFIED MANIFESTATIONS, UNCONTROLLED
249.90*
SECONDARY DIABETES MELLITUS WITH UNSPECIFIED COMPLICATION, NOT STATED AS UNCONTROLLED, OR
UNSPECIFIED
249.91*
SECONDARY DIABETES MELLITUS WITH UNSPECIFIED COMPLICATION, UNCONTROLLED
250.60*
DIABETES WITH NEUROLOGICAL MANIFESTATIONS, TYPE II OR UNSPECIFIED TYPE, NOT STATED AS
UNCONTROLLED
250.61*
DIABETES WITH NEUROLOGICAL MANIFESTATIONS, TYPE I [JUVENILE TYPE], NOT STATED AS
UNCONTROLLED
250.62*
DIABETES WITH NEUROLOGICAL MANIFESTATIONS, TYPE II OR UNSPECIFIED TYPE, UNCONTROLLED
250.63*
DIABETES WITH NEUROLOGICAL MANIFESTATIONS, TYPE I [JUVENILE TYPE], UNCONTROLLED
250.70* DIABETES WITH PERIPHERAL CIRCULATORY DISORDERS, TYPE II OR UNSPECIFIED TYPE, NOT STATED AS
UNCONTROLLED
250.71*
DIABETES WITH PERIPHERAL CIRCULATORY DISORDERS, TYPE I [JUVENILE TYPE], NOT STATED AS
UNCONTROLLED
250.72*
DIABETES WITH PERIPHERAL CIRCULATORY DISORDERS, TYPE II OR UNSPECIFIED TYPE, UNCONTROLLED
250.73*
DIABETES WITH PERIPHERAL CIRCULATORY DISORDERS, TYPE I [JUVENILE TYPE], UNCONTROLLED
- page 105 -
July 2013
250.80*
DIABETES WITH OTHER SPECIFIED MANIFESTATIONS, TYPE II OR UNSPECIFIED TYPE, NOT STATED AS
UNCONTROLLED
250.81*
DIABETES WITH OTHER SPECIFIED MANIFESTATIONS, TYPE I [JUVENILE TYPE], NOT STATED AS
UNCONTROLLED
250.82*
DIABETES WITH OTHER SPECIFIED MANIFESTATIONS, TYPE II OR UNSPECIFIED TYPE, UNCONTROLLED
250.83*
DIABETES WITH OTHER SPECIFIED MANIFESTATIONS, TYPE I [JUVENILE TYPE], UNCONTROLLED
459.81* VENOUS (PERIPHERAL) INSUFFICIENCY UNSPECIFIED
For Q4101, Q4102, Q4106, Q4107, Q4110, Q4121, Q4124:
The following ICD-9-CM codes may be used alone:
Group 4 Codes:
Group 4 Codes:
• 454.0 VARICOSE VEINS OF LOWER EXTREMITIES WITH ULCER
• 454.2 VARICOSE VEINS OF LOWER EXTREMITIES WITH ULCER AND INFLAMMATION
• 940.0 - 949.5* CHEMICAL BURN OF EYELIDS AND PERIOCULAR AREA - DEEP NECROSIS OF UNDERLYING
TISSUES DUE TO BURN (DEEP THIRD DEGREE UNSPECIFIED SITE WITH LOSS OF A BODY PART
Group 4 Medical Necessity ICD-9 Codes Asterisk Explanation: ** 940.0-949.5 to be used only for
TransCyte™, OrCel™ and other similar products when used in burn treatment when such use is medically
reasonable and necessary and consistent with FDA labeling. For information only; not part of this policy.
For Q4101, Q4102, Q4106, Q4107, Q4110, Q4121 and Q4124:
diagnosis.
Primary diagnoses:
Group 5 Codes:
July 2013
- page 106 -
For Q4101, Q4102, Q4106, Q4107, Q4110, Q4121 and Q4124:
Group 6 Codes:
249.00*
SECONDARY DIABETES MELLITUS WITHOUT MENTION OF COMPLICATION, NOT STATED AS UNCONTROLLED, OR
UNSPECIFIED
249.01*
SECONDARY DIABETES MELLITUS WITHOUT MENTION OF COMPLICATION, UNCONTROLLED
249.10*
SECONDARY DIABETES MELLITUS WITH KETOACIDOSIS, NOT STATED AS UNCONTROLLED, OR UNSPECIFIED
249.11*
249.20*
249.21*
249.30*
SECONDARY DIABETES MELLITUS WITH OTHER COMA, NOT STATED AS UNCONTROLLED, OR UNSPECIFIED
249.31*
249.40*
UNSPECIFIED
249.41*
249.50*
UNSPECIFIED
249.51*
249.60*
OR UNSPECIFIED
249.61*
249.70*
249.71*
249.80*
SECONDARY DIABETES MELLITUS WITH OTHER SPECIFIED MANIFESTATIONS, NOT STATED AS UNCONTROLLED,
OR UNSPECIFIED
249.81*
249.90*
UNSPECIFIED
249.91*
250.60*
UNCONTROLLED
250.61*
- page 107 -
July 2013
DIABETES WITH NEUROLOGICAL MANIFESTATIONS, TYPE I [JUVENILE TYPE], NOT STATED AS UNCONTROLLED
250.62*
250.63*
250.70*
DIABETES WITH PERIPHERAL CIRCULATORY DISORDERS, TYPE II OR UNSPECIFIED TYPE, NOT STATED AS
UNCONTROLLED
250.71*
UNCONTROLLED
250.72*
250.73*
250.80*
UNCONTROLLED
250.81*
DIABETES WITH OTHER SPECIFIED MANIFESTATIONS, TYPE I [JUVENILE TYPE], NOT STATED AS UNCONTROLLED
250.82*
250.83*
459.81*
VENOUS (PERIPHERAL) INSUFFICIENCY UNSPECIFIED
459.81, the provider must use both a code from the diabetes range (249.00250.83) or 459.81 and a code from the ulcer of lower limb range (707.10-707.19).
For Q4106:
The following ICD-9-CM code may be used alone:
Group 7 Codes:
757.39* OTHER SPECIFIED CONGENITAL ANOMALIES OF SKIN
Group 7 Medical Necessity ICD-9 Codes Asterisk Explanation: **ICD-9-CM code 757.39 may be used only for
epidermolysis bullosa
For Q4106, Q4107:
diagnosis.
Primary diagnoses:
Group 8 Codes:
July 2013
- page 108 -
terms of this LCD, CGS’ intent is for the use of this product to lower limb ulcers caused by diabetes. When
billing for ulcers caused by diabetes, the provider must use both a code from the diabetes range (249.00250.83) and a code from the ulcer of lower limb range (707.10-707.19).
Group 9 Paragraph: Group 6B For Q4106, Q4107:
Group 9 Codes:
249.00* SECONDARY DIABETES MELLITUS WITHOUT MENTION OF COMPLICATION, NOT STATED AS
249.01* SECONDARY DIABETES MELLITUS WITHOUT MENTION OF COMPLICATION, UNCONTROLLED
249.10*
SECONDARY DIABETES MELLITUS WITH KETOACIDOSIS, NOT STATED AS UNCONTROLLED, OR UNSPECIFIED
249.11*
249.20*
249.21*
249.30* SECONDARY DIABETES MELLITUS WITH OTHER COMA, NOT STATED AS UNCONTROLLED, OR
UNSPECIFIED
249.31*
249.40*
UNSPECIFIED
249.41*
249.50*
UNSPECIFIED
249.51*
249.60*
OR UNSPECIFIED
249.61*
249.70*
249.71*
249.80*
SECONDARY DIABETES MELLITUS WITH OTHER SPECIFIED MANIFESTATIONS, NOT STATED AS UNCONTROLLED,
OR UNSPECIFIED
249.81*
249.90*
UNSPECIFIED
249.91*
- page 109 -
July 2013
250.60*
UNCONTROLLED
250.61*
DIABETES WITH NEUROLOGICAL MANIFESTATIONS, TYPE I [JUVENILE TYPE], NOT STATED AS UNCONTROLLED
250.62*
250.63*
250.70*
DIABETES WITH PERIPHERAL CIRCULATORY DISORDERS, TYPE II OR UNSPECIFIED TYPE, NOT STATED AS
UNCONTROLLED
250.71*
UNCONTROLLED
250.72*
250.73*
250.80*
UNCONTROLLED
250.81*
DIABETES WITH OTHER SPECIFIED MANIFESTATIONS, TYPE I [JUVENILE TYPE], NOT STATED AS UNCONTROLLED
250.82*
250.83*
terms of this LCD, CGS’ intent is for the use of this product to lower limb ulcers caused by diabetes. When
billing for ulcers caused by diabetes, the provider must use both a code from the diabetes range (249.00250.83) and a code from the ulcer of lower limb range (707.10-707.19).
ICD-9 Codes that DO NOT Support Medical Necessity
Paragraph: All ICD-9-CM codes not listed under ICD-9-CM Codes that Support Medical Necessity above.
N/A
General Information
Associated Information N/A
Sources of Information and Basis for Decision
FDA Approval Notice, dated May 22, 1998
FDA Approval Notice for neuropathic diabetic foot ulcers Decision dated June 20, 2000
CMD Surgery/Surgery New Technology Workgroup
Consultants from Podiatry, Vascular Surgery, Orthopedic Surgery, Plastic Surgery
“Diabetic Foot Disorders, A Clinical Practice Guideline (2006 revision),” supplement to The Journal of Foot &
Ankle Surgery, September/October 2006, Volume 45, Number 5
Falanga, V., & Sabolinski, M., “ bilayered living skin construct (Apligraf ) accelerates complete closure of hard-toheal venous ulcers,” Wound Repair and Regeneration, vol. 7, No. 4, July-August 1999.
July 2013
- page 110 -
Prescribing Information: Apligraf (graftskin), Organogenesis Inc.
Olin, J.W., Beusterien, K.M., Childs, M. B., Seavy, C., Griffiths, R.I., “Medical costs of treating venous stasis ulcers:
evidence from a retrospective cohort study,” Vascular Medicine, volume 4, pp. 1-7, 1999.
Behavior of Tissue Engineered Skin, A Comparison of a Living Skin Equivalent, Autograft, and Occlusive Dressing
in Human Donor Sites, Muhart, et al., Archives of Dermatology, August 1999 (Reprint).
Cadaveric Allograft as Adjunct Therapy for Nonhealing Ulcers, Snyder, et al., Journal of Foot and Ankle Surgery,
March/April, 1999 (Abstract).
Rapid Healing of Venous Ulcers and Lack of Clinical Rejection with an Allogenic Cultured Human Skin
Equivalent, Falanga, et al., Archives of Dermatology, March, 1998 (Abstract).
Veves et. al., Graftskin, A Human Equivalent, is Effective in the Management of Noninfected Neuropathic Diabetic
Foot Ulcers, 291 Diabetes Care (Feb. 2001).
Food and Drug Administration, “Guidance for Industry, Chronic Cutaneous Ulcer and Burn Wounds – Developing
Products for Treatment” at http://www.fda.gov/cder/guidance/5512fnl.pdf. See 21 C.F.R. § 860.7(c)(2).
Effectiveness of an extracellular matrix graft (OASIS Wound Matrix) in the treatment of chronic leg ulcers: a
randomized clinical trial. Mostow EN, Haraway GD, Dalsing M, Hodde JP, King D; OASIS Venus Ulcer Study Group.
J Vasc Surg. 2005 May;41(5):837-43.
Karr, Jeffrey, DPM, “Retrospective Comparison of Diabetic Foot Ulcer and Venous Stasis Ulcer Healing Outcome
Between a Dermal Repair Scaffold (PriMatrix) and a Bilayered Living Cell Therapy (Apligraf ),” Advances in Skin &
Wound Care, Volume 24, number 3, March 2011.
Lawrence DiDomenico, DPM, FACFAS;1 Kenneth J. Emch, DPM, FACFAS;1, Arnold R. Landsman, DPM;2
Adam Landsman, DPM, PhD, FACFAS, A Prospective Comparison of Diabetic Foot Ulcers Treated With Either
a Cryopreserved Skin Allograft or a Bioengineered Skin Substitute, WOUNDS 2011;23(7):184–189.
Snyder, David L., PH.D; Sulliva, Nancy, B.A.; Scholles, Karen M., M.D., S. M., F.A.C. P, “Skin Substitutes for Treating
Chronic Wounds” at http://www.ahrq.gov/research/findings/ta/skinsubs/HCPR0610_skinsubst-final.pdf
Other carriers’ policies
CGS Carrier Advisory Committee Members
Revision History Information
N/A
Associated Documents
Attachments
N/A
Related Local Coverage Documents
N/A
Related National Coverage Documents
N/A
All Versions
Updated on 04/30/2013 with effective dates 05/01/2013 - N/A
Keywords
N/A
Read the LCD Disclaimer opens in new window
- page 111 -
July 2013
Join the
CGS ListServ
By joining the CGS electronic mailing list, you can
get immediate updates on Medicare information,
including:
Medicare publications
Important updates
Workshops
Medical Review information
To join the ListServ follow this link:
https://www.cgsmedicare.com/medicare_
dynamic/ls/001.asp
- page 112 -
July 2013
Overpayment Refunds
Personal provider checks sent to us for any reason should be sent to the following address (if
you are submitting a refund due to Medicare Secondary Payer, include “MSP” on the envelope or
correspondence):
Kentucky and Ohio Providers
CGS – J15 Part B Kentucky and Ohio
PO Box 957065
St. Louis, MO 63195-7065
Personal provider checks should never be sent to our Nashville operations as this will create
processing delays. For example, in situations where you have received a letter of notification regarding
a Medicare overpayment, these delays can result in payment offset and/or interest accrual.
Checks issued by CGS that need to be returned to us should be sent to the following address:
Kentucky and Ohio Providers
CGS – J15 Part B Kentucky and Ohio
PO Box 957065
St. Louis, MO 63195-7065
Medicare Bulletin
. . . a service of CGS
Two Vantage Way
Nashville, TN 37228
The CGS website (www.cgsmedicare.com) provides formal notification for all notices developed
and distributed by CGS, including the Part B Medicare Bulletin. Providers/suppliers are obligated and
responsible for remaining updated on current Medicare issues and legislation as it is posted to the
website.
Please note that for LCDs listed on the website, the start of the notice period may be different than
the date it is posted to the website. Please abide by the notice period dates on the document, not
the posting date.
A quarterly CD-ROM, which includes the Medicare Bulletin and other additional resources, is mailed
to the same location as Medicare checks. Provider groups will receive one copy of the CD-ROM.
Each individual provider in that group will not receive their own copy for his/her individual provider
identification number (PIN).
July 2013
- page 113 -
OHIO
OH Insert, page 114
July 2013
This newsletter should be shared with all health care practitioners and managerial
members of the provider/supplier staff. Newsletters issued after January 1997 are
available at no cost from our Web site at www.cgsmedicare.com.

OHIO Part B Medicare Bulletin

Transcription

Similar documents

Patient Forms

PDF - National Union of Public and General Employees

ameriflex - Montville.net

Saebo Long Term Care Program

Key Changes with Health Reform - The National Association of State

smart healthcare consumer

SAVE 50%

Completing the CMS-855A Enrollment Application

SHIIP provides unbiased help with Medicare