L33370 - breathing meds, Patient Care Pharmacy, Inc. Home
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L33370 - breathing meds, Patient Care Pharmacy, Inc. Home
Page 1 of 46 Local Coverage Determination for Nebulizers (L33370) Skip to Main Content Main Menu . Back to Local Coverage Determinations (LCDs) for Noridian Healthcare Solutions. LLC {19003. DME MAC) for Noridian Healthcare Solutions. LLC (19003 - DME MAC) Local Coverage Determination (LCD): Nebulizers (L33370) Select the Print Complete Record, Add to Basket or Email Record Buttons to print the record, to add it to your basket or to email the record. Printing Note: To print an entire document, including all codes in all code groups, use the Need a PDF Button or the Print Complete Record Button. To print only the current visible page contents, use the Print Button in the page header. Section Navigation El !select Section Go - Contractor Information TYPE CONTRACT NUMBER JURISDICTION STATE(S) CGS Administrators LLC DMEMAC 18003 - DME MAC J-C Alabama Arkansas Colorado Florida Georgia Louisiana Mississippi North Carolina New Mexico Oklahoma Puerto Rico South Carolina Tennessee Texas Virginia Virgin Islands West Virginia National Government Services, Inc. DMEMAC 17003 • DME MAC J·B Illinois Indiana Kentucky Michigan Minnesota Ohio Wisconsin NHIC, Corp. DME MAC 16003 • OME MAC J-A Connecticut District of Columbia Delaware Massachusetts Maryland Maine New Hampshire New Jersey New York· Entire State Pennsylvania Rhode Island Vermont Noridian Heallhcare Solutions, LLC DMEMAC 19003 • DME MAC J-0 Alaska American Samoa Arizona California • Entire State Guam Hawaii Iowa CONTRACTOR NAME CONTRACT https://www.cms.gov/mcdicare-coverage-database/details/lcd-details.aspx?LCDid=33370 ... 2/16/2016 Page 2 of 46 Local Coverage Determmation tor Nebuhzers (LJJJ'/U) Idaho Kansas Missouri - Entire State Montana North Dakota Nebraska Nevada Oregon South Dakota Utah Washington Wyoming Northern Mariana Islands Back to Too - 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. https://www.cms.gov/medicare-coverage-databasc/details/lcd-details.aspx?LCDld=33370 ... 2/16/2016 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 https://wv,,rw.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDid=33370 ... 2/16/2016 Page 29 of 46 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 -� :�����hg ICD-10 Codes that Support Medical Necessity textbox ii:earch By: §WI.IApltl&n>elO Codes that Support Medical Necessity radio button GOllliap 8 ICD-10 Codes that Support Medical Necessity radio button Search Group 8 ICD-10 Codes that Support Medical Necessity Submit button ICD-10 Codes that Support Medical Necessity Clear button SEARCH GROUP Search Group 8 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 ... 2/16/2016 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 https://www.ems.gov/medicare-coverage-database/detai ls/lcd-details.aspx?LCD Id=3 3 3 70... Page 30 of 46 2/ 16/2016 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 https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDid=33370 ... 2/16/2016 Local Coverage Determination for Nebulizers (L33370) Page 41 of 46 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. https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDid=33370 ... 2/17/2016 Local Coverage Determination for Nebulizers (L33370) Page 44 of 46 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