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Local Coverage Determination for Nebulizers (L33370)
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Local Coverage Determination (LCD):
Nebulizers (L33370)
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2/16/2016
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Local Coverage Determmation tor Nebuhzers (LJJJ'/U)
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- LCD Information
Document Information
LCDID
L33370
Original ICD·9 LCD ID
.b§.QQl
LCD Title
Nebulizers
AMA CPT I ADA CDT I AHA NUBC Copyright Statement
CPT only copyright 2002-2015 American Medical Associalion. All
Rights Reserved. CPT is a registered trademark or 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 or 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.
Original Effective Date
For services performed on or after
10/01/2015
Revision Effective Date
For services performed on or after
01/01/2016
Revision Ending Date
NIA
Retirement Date
NIA
Notice Period Start Date
NIA
Notice Period End Date
NIA
The Code on Dental Procedures and Nomenclature (Code) is
published in Current Dental Terminology (COT). Copyright©
American Dental Assodalion. All rights reserved. CDT and CDT2010 are trademarks of the American Dental Association.
UB-04 Manual. OFFICIAL UB-04 DATA SPECIFICATIONS
MANUAL, 2014, is copyrighted by American Hospital Association
("AHA'), Chicago, Illinois. No portion of OFFICIAL UB-04 MANUAL
may be reproduced, sorted in a retrieval system, or transmilted, in
any form or by any means, electronic, mechanical, photocopying,
recording or otherwise, without prior express, written consent or
AHA." Health Forum reserves the right to change the copyright
notice from time to time upon written nolice to Company.
CMS National Coverage Policy
CMS Manual System, Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Section 200.2, Section
280.1
Coverage Guidance
Coverage Indications, Limitations, and/or Medical Necessity
For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and
necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3)
meet all other applicable Medicare statutory and regulatory requirements. For the items addressed in this local coverage
determination. the criteria for "reasonable and necessary", based on Social Security Act§ 1862(a)(1 )(A) provisions, are
defined by the following coverage indications, limitations and/or medical necessity.
Medicare does not automatically assume payment for a durable medical equipment, prosthetics, orthotics and supplies
(DMEPOS) item that was covered prior to a beneficiary becoming eligible for the Medicare Fee for Service (FFS) program.
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Local Coverage Determination for Nebulizers (L33370)
Page 3 of 46
VI/hen a beneficiary receiving a DMEPOS item from another payer (including Medicare Advantage plans) becomes eligible for
the Medicare FFS program, Medicare will pay for continued use of the DMEPOS item only if all Medicare coverage, coding
and documentation requirements are met. Additional documentation to support that lhe ilem is reasonable and necessary, may
be required upon request of the DME MAC.
For an item to be covered by Medicare, a detailed written order (DWO) must be received by the supplier before a claim is
submitted. If the supplier bills for an item addressed in this policy without first receiving the completed DWO, the item will be
denied as not reasonable and necessary.
For some items in this policy to be covered by Medicare, a written order prior to delivery (WOPD) is required. Refer to the
DOCUMENTATION REQUIREMENTS section of this LCD and to the NON-MEDICAL NECESSITY COVERAGE AND
PAYMENT RULES section of the related Policy Article for information about WOPD prescription requirements.
A small volume nebulizer (A7003, A7004, A7005), related compressor (E0570) and F.DA-approved inhalation solutions of !he
drugs listed below are covered when:
a. It is reasonable and necessary to administer albuterol (J7611, J7613), arformoterol (J7605), budesonide (J7626),
cromolyn (J7631), formoterol (J7606), ipratropium (J7644), levalbuterol (J7612, J7614), or metaproterenol (J7669) for
!he management of obstructive pulmonary disease (Reference the Diagnosis Codes that Support Medical Necessity
Group 8 Codes seclion for applicable diagnoses); or
b. It is reasonable and necessary to administer dornase alpha (J7639) to a beneficiary with cystic fibrosis (Reference the
Diagnosis Codes that Support Medical Necessity Group 9 Codes section for applicable diagnoses); or
c. It is reasonable and necessary to administer tobramycin {J7682) to a beneficiary with cystic fibrosis or bronchiectasis
(Reference lhe Diagnosis Codes that Support Medical Necessity Group 10 Codes section for applicable diagnoses); or
d. It is reasonable and necessary to administer pentamidine (J2545) to a beneficiary with HIV, pneumocystosis, or
complications of organ transplants (Reference the Diagnosis Codes that Support Medical Necessity Group 4 Codes
section for applicable diagnoses); or
e. It is reasonable and necessary to administer acetylcysteine (J7608) for persistent thick or tenacious pulmonary
secretions (Reference the Diagnosis Codes that Support Medical Necessity Group 7 Codes section for applicable
diagnoses).
Compounded inhalation solutions (J7604, J7607, J7609, J7610, J7615, J7622, J7624, J7627, J7628, J7629, J7632, J7634,
J7635,J7636,J7637,J7638,J7640,J7641,J7642,J7643,J7645,J7647,J7650,J7657,J7660,J7667,J7670,J7676,J7680,
J7681, J7683, J7684, J7685, and compounded solutions billed with J7699) will be denied as not reasonable and necessary.
If none of the drugs used with a nebulizer are covered, the compressor, the nebulizer, and other related accessories/supplies
will be denied as not reasonable and necessary.
A large volume nebulizer (A7007, A7017), related compressor (E0565 or E0572), and water or saline (A4217 or A7018) are
covered when it is reasonable and necessary to deliver humidity to a beneficiary with !hick, tenacious secretions, who has
cystic fibrosis, bronchieclasis, a tracheostomy, or a tracheobronchial stent (Reference the Diagnosis Codes that Support
Medical Necessity Group 5 Codes section for applicable diagnoses). Combination code E0585 will be covered for the same
indications.
An E0565 or E0572 compressor and filtered nebulizer (A7006) are also covered when it is reasonable and necessary to
administer pentamidine to beneficiaries with HIV, pneumocystosis, or complications of organ transplants (Reference lhe
Diagnosis Codes that Support Medical Necessity Group 1 Codes section for applicable diagnoses).
A small volume ultrasonic nebulizer (E0574) and related accessories are reasonable and necessary to administer treprostinil
inhalation solution only. Claims for code E0574 used with other inhalation solutions will be denied as nol reasonable and
necessary.
Treprostinil inhalation solution (J7686) and iloprost (04074) are covered when all of the following criteria 1-3 are met:
1. The beneficiary has a diagnosis of pulmonary artery hypertension (Reference the Diagnosis Codes that Support Medical
Necessity Group 1 Codes seclion for applicable diagnoses); and
2. The pulmonary hypertension is not secondary to pulmonary venous hypertension (e.g., left sided atrial or ventricular
disease, left sided valvular heart disease, etc) or disorders of the respiratory system (e.g., chronic obstructive pulmonary
disease, interstitial lung disease, obstructive sleep apnea or other sleep disordered breathing, alveolar hypoventilation
disorders, etc.); and
3. The beneficiary has primary pulmonary hypertension or pulmonary hypertension which is secondary to one of the
following conditions: connective tissue disease, thromboembolic disease of the pulmonary arteries, human
immunodeficiency virus (HIV) infection, cirrhosis, anorexigens or congenilal left to right shunts. If these conditions are
present, the following criteria (a-d) must be met:
a. The pulmonary hypertension has progressed despite maximal medical and/or surgical treatment of the identified
condition; and
b. The mean pulmonary artery pressure is > 25 mm Hg at rest or> 30 mm Hg with exertion; and
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Local Coverage Determination for Nebulizers (L33370)
J62.8
Pneumoconiosis due to other dust containing silica
J63.0
Aluminosis (of lung)
J63.1
Bauxite fibrosis (of lung)
J63.2
Berylliosis
Showing 1 to 100 of 138 entries in Group 7
First Prev
¢ur!?!ntly Sektcted �
Group 8 Paragraph:
For HCPCS codes J7605, J7606, J7611, J7612, J7613, J7614 J7620, J7626, J7631, J7644,
J7669:
Group 8 Codes:
Show entries
:�p 8 ICD-10 Codes that Support Medical Necessity
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SEARCH GROUP
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CLEAR SEARCH
ICD-10 CODE
DESCRIPTION
J41.0
Simple chronic bronchitis
J41.1
Mucopurulent chronic bronchilis
J41.8
Mixed simple and mucopurulent chronic bronchitis
J42
Unspecified chronic bronchitis
J43.0
Unilateral pulmonary emphysema [Macleod's syndrome]
J43.1
Panlobular emphysema
J43.2
Centrilobular emphysema
J43.8
Other emphysema
J43.9
Emphysema, unspecified
J44.0
Chronic obstructive pulmonary disease with acute tower respiratory infeclion
J44.1
Chronic obstructive pulmonary disease with (acute) exacerbation
J44.9
Chronic obstructive pulmonary disease. unspecified
J45.20
Mild intermittent asthma, uncomplicated
J45.21
Mild intermittent asthma with (acute) exacerbation
J45.22
Mild intermittent asthma with status asthmaticus
J45.30
Mild persistent asthma, uncomplicated
J45.31
Mild persistent asthma with (acute) exacerbation
https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDid=33370 ...
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Local Coverage Determination for Nebulizers (L33370)
J45.32
Mild persistent asthma with status asthmaticus
J45.40
Moderate persistent asthma, uncomplicated
J45.41
Moderate persistent asthma with (acute) exacerbation
J45.42
Moderate persistent asthma with status asthmaticus
J45.50
Severe persistent asthma, uncomplicated
J45.51
Severe persistent asthma with (acute) exacerbation
J45.52
Severe persistent asthma with status asthmaticus
J45.901
Unspecified asthma with (acute) exacerbation
J45.902
Unspecified asthma with status asthmalicus
J45.909
Unspecified asthma, uncomplicated
J45.990
Exercise induced bronchospasm
J45.991
Cough variant asthma
J45.998
Other asthma
J47.0
Bronchiectasis with acute lower respiratory infection
J47.1
Bronchiectasis with (acute) exacerbation
J47.9
Bronchieclasis, uncomplicated
J60
Coalworker's pneumoconiosis
J61
Pneumoconiosis due to asbestos and other mineral fibers
J62.0
Pneumoconiosis due to talc dust
J62.8
Pneumoconiosis due to other dust containing silica
J63.0
Aluminosis (of lung)
J63.1
Bauxite fibrosis (or lung)
J63.2
Berylliosis
J63.3
Graphite fibrosis (or lung)
J63.4
Siderosis
J63.5
Stannosis
J63.6
Pneumoconiosis due to other specified inorganic dusts
J64
Unspecified pneumoconiosis
J65
Pneumoconiosis associated with tuberculosis
J66.0
Byssinosis
J66.1
Flax-dressers' disease
J66.2
Cannabinosls
J66.8
Airway disease due to other specific organic dusts
J67.0
Farmer's lung
J67.1
Bagassosis
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Local Coverage Determination for Nebulizers (L33370)
J67.2
Bird fancler's lung
J67.3
Suberosis
J67.4
Maltworke(s lung
J67.5
Mushroom-worker's lung
J67.6
Maple-bark-strippe(s lung
J67.7
Air conditioner and humidifier lung
J67.8
Hypersensitivity pneumonitis due to other organic dusts
J67.9
Hypersensitivity pneumonitis due to unspecified organic dust
J68.0
Bronchitis and pneumonitis due to chemicals, gases, fumes and vapors
J68.1
Pulmonary edema due to chemicals, gases, fumes and vapors
J68.2
Upper respiratory inflammation due lo chemicals, gases, fumes and vapors, not
elsewhere classified
J68.3
Other acute and subacute respiratory conditions due lo chemicals, gases, fumes
and vapors
J66.4
Chronic respiratory conditions due to chemicals, gases, fumes and vapors
J66.8
Other respiratory conditions due to chemicals, gases, fumes and vapors
J68.9
Unspecified respiratory condition due to chemicals, gases, fumes and vapors
J69.0
Pneumonilis due to inhalation of food and vomit
J69.1
Pneumonilis due to inhalation of oils and essences
J69.8
Pneumonilis due lo inhalation of other solids and liquids
J70.0
Acute pulmonary manifestations due to radiation
J70.1
Chronic and other pulmonary manifestations due to radiation
J70.2
Acute drug-induced interstitial lung disorders
J70.3
Chronic drug-induced interstitial lung disorders
J70.4
Drug-induced interstitial lung disorders, unspecified
J70.5
Respiratory conditions due to smoke inhalation
J70.8
Respiratory conditions due to other specified external agents
J70.9
Respiratory conditions due to unspecified external agent
Page 31 of 46
Showing 1 to 78 of 78 entries in Group 8
First Prev
G:unNetty S�ed
Group 9 Paragraph:
For HCPCS code J7639:
Group 9 Codes:
Show entries
:¥1'.)gj;r�p 9 ICD-10 Codes that Support Medical Necessity
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Local Coverage Determination for Nebulizers (L33370)
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DETAILED WRITTEN ORDERS (PIM 5.2.3)
A detailed written order (DWO) is required before billing. Someone other than the ordering physician may produce the DWO.
However, the ordering physician must review the content and sign and date the document. It must contain:
Beneficiary's name
Physician's name
Date of the order
Detailed description of the item(s) (see below for specific requirements for selected items)
Physician signature and signature date
For items provided on a periodic basis, including drugs, the written order must include:
ltem(s) to be dispensed
Dosage or concentration, if applicable
Route of Administration
Frequency of use
Duration of infusion, if applicable
Quantity to be dispensed
Number of refills
For the "Date of the order'' described above, use the date the supplier is contacted by the physician (for verbal orders) or the
date entered by the physician (for written dispensing orders).
With respect to the date on the DWO/WOPD:
1. If the prescriber creates a complete and compliant DWO/WOPD, only a single date - the "order date" - is required. This
order date may be the date that the prescriber signs the document (either wet signature or electronic signature)
2. If someone other than the prescriber (e.g., DME supplier) creates the DWO/WOPD then the prescription must be
reviewed and, " ... personally signed and dated ... " by the prescriber. In this scenario two (2) dates are required: an
"order date" and a prescriber-entered "signature date".
In some cases, the physician may specify a future start date for therapy that is different from the date of the order. This start
date does not impact the date of service (DOS) entered on the claim, Medicare-required forms (e.g., CMN, DIF) or
refill/delivery timelines. As long as the supplier has a properly completed prescription with a correctly determined prescription
date, an item may be shipped or delivered on or after the prescription date (except for items that require written orders prior
·
to delivery).
Frequency of use information on orders must contain detailed instructions for use and specific amounts to be dispensed.
Reimbursement shall be based on the specific utilization amount only. Orders that only state "PRN" or "as needed'futiliaation
estimates for replacement frequency, use, or consumption are not acceptable. (PIM 5.9)
The detailed description in the written order may be either a narrative description or a brand name/model number.
Signature and date stamps are not allowed. Signatures must comply with the CMS signature requirements outlined in PIM
3.3.2.4.
The DWO must be available upon request.
A prescription is not considered as part of the medical record. Medical information intended to demonstrate compliance with
coverage criteria may be included on the prescription but must be corroborated by information contained in the medical
record. (PIM 5.2.3)
MEDICAL RECORD INFORMATION
GENERAL (PIM 5.7 - 5.9)
The Coverage Indications, Limitations and/or Medical Necessity section of this LCD contains numerous reasonable and
necessary (R&N) requirements. The Non-Medical Necessity Coverage and Payment Rules section of the related Policy
Article contains numerous non-reasonable and necessary, benefit category and statutory requirements that must be met in
order for payment to be justified. Suppliers are reminded that:
Supplier-produced records, even if signed by the ordering physician, and attestation letters (e.g. letters of medical
necessity) are deemed not to be part of a medical record for Medicare payment purposes.
• Templates and forms, including CMS Certificates of Medical Necessity, are subject to corroboration with information in
the medical record.
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Quantity delivered
Date delivered
Evidence of delivery
If a supplier utilizes a shipping service or mail order, suppliers must use the shipping date as the date of service on the claim. ·
Suppliers may also utilize a return postage-paid delivery invoice from the beneficiary or designee as a POD. This type of
POD record must contain the information specified above.
EQUIPMENT RETAINED FROM A PRIOR PAYER
When a beneficiary receiving a DMEPOS item from another payer (including a Medicare Advantage plan) becomes eligible
for the Medicare FFS program, the first Medicare claim for that item or service is considered a new initial Medicare claim for
the item. Even if there is no change in the beneficiary's medical condition, the beneficiary must meet all coverage, coding and
documentation requirements for the DMEPOS item in effect on the date of service of the initial Medicare claim.
A POD is required for all items, even those in the beneficiary's possession provided by another insurer prior to Medicare
eligibility. To meet the POD requirements for a beneficiary transitioning to Medicare, the supplier:
1. Must obtain a new POD as described above under "Methods of Delivery" (whichever method is applicable); or,
2. Must obtain a statement, signed and dated by the beneficiary (or beneficiary's designee), attesting that the supplier has
examined the DMEPOS item, it is in good working order and that it meets Medicare requirements.
For the purposes of reasonable useful lifetime and calculation of continuous use, the first day of the first rental month in which
Medicare payments are made for the item (i.e., date of service) serves as the start date of the reasonable useful lifetime and
period of continuous use. In these cases, the proof of delivery documentation serves as evidence that the beneficiary is
already in possession of the item.
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS
AFFORDABLE CARE ACT (ACA) 6407 REQUIREMENTS
ACA 6407 contains provisions that are applicable to certain specified items in this policy. In this policy the specified items are:
I
I
I
I
E0570
E057�
E0580
E0585
K0730
I
II
I
NEBULIZER, WITH COMPRESSOR
NEBULIZER, ULTRASONIC, LARGE VOLUME
I
I
NEBULIZER, DURABLE, GLASS OR AUTOCLAVABLE PLASTIC, BOTTLE TYPE, FOR USE WITH
REGULATOR OR FLOWMETER
I
NEBUUZER, WITH COMPRESSOR AND HEATER
I
CONTROLLED DOSE INHALATION DRUG DELIVERY SYSTEM
These items require an in-person or face-to-face interaction between the beneficiary and their treating physician prior to
prescribing the item, specifically to document that the beneficiary was evaluated and/or treated for a condition that supports
the need for the item(s) of DME ordered. A dispensing order is not sufficient to provide these items. A WOPD is required.
Refer to the related Policy Article NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES section for information
about these statutory requirements.
The DMEPOS supplier must have documentation of both the face-to-face visit and the completed WOPD in their file prior to
the delivery of these items.
Suppliers are reminded that all Medicare coverage and documentation requirements for DMEPOS also apply. There must be
sufficient information included in the medical record to demonstrate that all of the applicable coverage criteria are met. This
information must be available upon request.
REPAIR/REPLACEMENT (BPM Ch 15, §110.2)
A new Certificate of Medical Necessity (CMN) and/or physician's order is not needed for repairs.
In the case of repairs to a beneficiary-owned DMEPOS item, if Medicare paid for the base equipment initially, medical
necessity for the base equipment has been established. With respect to Medicare reimbursement for the repair, there are two
documentation requirements:
1. The treating physician must document that that the DMEPOS item being repaired continues to be reasonable and
necessary (see Continued Medical Need section above); and,
https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDld=33370 ...
2/17/2016