Local Coverage Determination (LCD)

Nebulizers

L33370

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Contractor Information

LCD Information

Document Information

LCD ID
L33370
LCD Title
Nebulizers
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL33370
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 06/05/2022
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
04/21/2022
Notice Period End Date
06/04/2022
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Issue

Issue Description

The final Nebulizers LCD extends coverage to treprostinil inhalation solution used in the treatment of pulmonary hypertension (PH) associated with interstitial lung disease (ILD) and removes coverage of treprostinil inhalation solution and iloprost used in the treatment of chronic thromboembolic pulmonary hypertension (CTEPH).

Issue - Explanation of Change Between Proposed LCD and Final LCD

The Nebulizers LCD is being finalized as proposed. 

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.

The purpose of a Local Coverage Determination (LCD) is to provide information regarding “reasonable and necessary” criteria based on Social Security Act § 1862(a)(1)(A) provisions.

In addition to the “reasonable and necessary” criteria contained in this LCD there are other payment rules, which are discussed in the following documents, that must also be met prior to Medicare reimbursement:

  • The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.

  • The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.

  • Refer to the Supplier Manual for additional information on documentation requirements.

  • Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

For the items addressed in this LCD, the “reasonable and necessary” criteria, based on Social Security Act § 1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity.

Payment may be made for supplies that are necessary for the effective use of durable medical equipment. Such supplies include those drugs and biologicals which must be put directly into the equipment in order to achieve the therapeutic benefit of the durable medical equipment or to assure the proper functioning of the equipment. However, the coverage of such drugs or biologicals does not preclude the need for a determination that the drug or biological itself is reasonable and necessary for treatment of the illness or injury or to improve the functioning of a malformed body member.

A small volume nebulizer (A7003, A7004, A7005), and related compressor (E0570) are considered for coverage when it is reasonable and necessary to administer the following FDA-approved inhalation solutions listed below (refer to the Group 3 Codes in the LCD-related Policy Article for applicable diagnoses):

  1. It is reasonable and necessary to administer albuterol (J7611, J7613), arformoterol (J7605), budesonide (J7626), cromolyn (J7631), formoterol (J7606), ipratropium (J7644), levalbuterol (J7612, J7614), metaproterenol (J7669), or revefenacin (J7677) for the management of obstructive pulmonary disease (refer to the Group 8 Codes in the LCD-related Policy Article for applicable diagnoses); or

  2. It is reasonable and necessary to administer dornase alfa (J7639) to a beneficiary with cystic fibrosis (refer to the Group 9 Codes in the LCD-related Policy Article for applicable diagnoses); or

  3. It is reasonable and necessary to administer tobramycin (J7682) to a beneficiary with cystic fibrosis or bronchiectasis (refer to the Group 10 Codes in the LCD-related Policy Article for applicable diagnoses); or

  4. It is reasonable and necessary to administer pentamidine (J2545) to a beneficiary with HIV, pneumocystosis, or complications of organ transplants (refer to the Group 4 Codes in the LCD-related Policy Article for applicable diagnoses); or

  5. It is reasonable and necessary to administer acetylcysteine (J7608) for persistent thick or tenacious pulmonary secretions (refer to the Group 7 Codes in the LCD-related Policy Article 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 considered for coverage when it is reasonable and necessary to deliver humidity to a beneficiary with thick, tenacious secretions, who has cystic fibrosis, bronchiectasis, a tracheostomy, or a tracheobronchial stent (refer to the Group 5 Codes in the LCD-related Policy Article for applicable diagnoses). Combination code E0585 will be covered for the same indications.

An E0565 or E0572 compressor and filtered nebulizer (A7006) are considered for coverage when it is reasonable and necessary to administer pentamidine to beneficiaries with HIV, pneumocystosis, or complications of organ transplants (refer to the Group 1 Codes in the LCD-related Policy Article for applicable diagnoses).

A small volume ultrasonic nebulizer (E0574) and related accessories are considered for coverage when it is reasonable and necessary to administer treprostinil inhalation solution to beneficiaries with pulmonary hypertension only (refer to the Group 11 Codes in the LCD-related Policy Article for applicable diagnoses). Claims for code E0574 used with other inhalation solutions will be denied as not reasonable and necessary.

Treprostinil inhalation solution (J7686) is considered for coverage when either criteria 1-3; or, criterion 4 are met:

  1. The beneficiary has a diagnosis of pulmonary artery hypertension (refer to the Group 11 Codes in the LCD-related Policy Article 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) or disorders of the respiratory system other than interstitial lung disease (see criterion 4) (e.g., chronic obstructive pulmonary disease, obstructive sleep apnea or other sleep disordered breathing, alveolar hypoventilation disorders); and

  3. The beneficiary has primary pulmonary hypertension or pulmonary hypertension which is secondary to one of the following conditions: connective tissue disease, human immunodeficiency virus (HIV) infection, cirrhosis, anorexigens or congenital left to right shunts. If these conditions are present, the following criteria (a-d) must be met:

    1. The pulmonary hypertension has progressed despite maximal medical and/or surgical treatment of the identified condition; and

    2. The mean pulmonary artery pressure is > 25 mm Hg at rest or > 30 mm Hg with exertion; and

    3. The beneficiary has significant symptoms from the pulmonary hypertension (i.e., severe dyspnea on exertion, and either fatigability, angina, or syncope); and

    4. Treatment with oral calcium channel blocking agents has been tried and failed, or has been considered and ruled out.

  4. The beneficiary has a diagnosis of pulmonary hypertension associated with interstitial lung disease (refer to Group 11 Codes in the LCD-related Policy Article for applicable diagnoses) and the following criteria (a-e) are met:

    1. The presence of interstitial lung disease has been confirmed by a high-resolution CT scan of the chest; and

    2. The mean pulmonary artery pressure is ≥ 25 mm Hg; and

    3. The pulmonary capillary wedge pressure or left ventricular end-diastolic pressure is ≤ 15mm Hg; and

    4. The pulmonary vascular resistance is ≥ 3 Wood Units at rest; and

    5. The beneficiary has significant symptoms of pulmonary hypertension (e.g., dyspnea on exertion, fatigability)

If the above criteria are not met, code E0574 and the related drug treprostinil (J7686) will be denied as not reasonable and necessary.

A controlled dose inhalation drug delivery system (K0730) is considered for coverage when it is reasonable and necessary to administer iloprost (Q4074) to beneficiaries with pulmonary hypertension only (refer to the Group 14 Codes in the LCD-related Policy Article for applicable diagnoses). Claims for code K0730 for use with other inhalation solutions will be denied as not reasonable and necessary.

Iloprost (Q4074) is considered for coverage when all of the following criteria 1-3 are met:

  1. The beneficiary has a diagnosis of pulmonary artery hypertension (refer to the Group 14 Codes in the LCD-related Policy Article 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) 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); and

  3. The beneficiary has primary pulmonary hypertension or pulmonary hypertension which is secondary to one of the following conditions: connective tissue disease, human immunodeficiency virus (HIV) infection, cirrhosis, anorexigens or congenital left to right shunts. If these conditions are present, the following criteria (a-d) must be met:

    1. The pulmonary hypertension has progressed despite maximal medical and/or surgical treatment of the identified condition; and

    2. The mean pulmonary artery pressure is > 25 mm Hg at rest or > 30 mm Hg with exertion; and

    3. The beneficiary has significant symptoms from the pulmonary hypertension (i.e., severe dyspnea on exertion, and either fatigability, angina, or syncope); and

    4. Treatment with oral calcium channel blocking agents has been tried and failed, or has been considered and ruled out.

If the above criteria are not met, code K0730 and the related drug iloprost (Q4074) will be denied as not reasonable and necessary.

A large volume ultrasonic nebulizer (E0575) offers no proven clinical advantage over a pneumatic compressor and nebulizer and will be denied as not reasonable and necessary.


ACCESSORIES:

Accessories are separately payable if the related aerosol compressor and the individual accessories are reasonable and necessary. The following table lists the compressor/generator, which is related to the accessories described. Other compressor/generator/accessory combinations are considered not reasonable and necessary.

Compressor/Generator Related Accessories
E0565 A4619, A7006, A7007, A7010, A7012, A7013, A7014, A7015, A7017, A7525, E1372
E0570 A7003, A7004, A7005, A7006, A7013, A7015, A7525
E0572 A7006, A7007, A7014, A7017
E0574 A7013, A7014, A7016
E0585 A4619, A7006, A7010, A7012, A7013, A7014, A7015, A7525
K0730 A7005


This array of accessories represents all possible combinations, but it may not be appropriate to bill any or all of them for one device.

The following table lists the usual maximum frequency of replacement for accessories. Claims for more than the usual maximum replacement amount will be denied as not reasonable and necessary.

Accessory  Usual maximum replacement
A4619  One/month
A7003  Two/month
A7004  Two/month (in addition to A7003)
A7005  One/6 months
A7005  One/3 months only with K0730
A7006  One/month
A7007  Two/month
A7010  One unit (100 ft.)/2 months
A7012  Two/month
A7013  Two/month
A7014  One/3 months
A7015  One/month
A7016  Two/year
A7017  One/3 years
A7525  One/month
E1372  One/3 years



 INHALATION DRUGS AND SOLUTIONS:

The following table represents the maximum milligrams/month of inhalation drugs that are reasonable and necessary for each nebulizer drug.

Inhalation Drugs and Solutions Maximum Milligrams/Month
Acetylcysteine 74 grams/month
Albuterol 465 mg/month (See below for exception)
Albuterol/Ipratropium combination 186 units/month
Arformoterol 930 micrograms/month – 62 units/month
Budesonide 62 units/month
Cromolyn sodium 2480 mg/month – 248 units/month
Dornase alfa 78 mg/month
Formoterol 1240 micrograms/month – 62 units/month
Ipratropium bromide 93 mg/month
Levalbuterol 232.5 mg/month – 465 units/month (See below for exception)
Metaproterenol 2800 mg/month – 280 units/month (See below for exception)
Pentamidine 300 mg/month
Revefenacin 5250 mcg/month
Treprostinil 31 units/month
Sterile saline or water, 10ml/unit (A4216, A4218) 56 units/month
Distilled water, sterile water, or sterile saline in large volume nebulizer 18 liters/month

 

Claims for more than these amounts of drugs will be denied as not reasonable and necessary.

When albuterol, levalbuterol, or metaproterenol are prescribed as rescue/supplemental medication for beneficiaries who are taking formoterol or arformoterol, the maximum milligrams/month that are reasonably billed are:

Inhalation Drugs and Solutions Maximum Milligrams/Month
Albuterol 78 mg/month
Albuterol/Ipratroprium combination 31 units/month
Levalbuterol 39 mg/month – 78 units/month
Metaproterenol 470 mg/month – 47 units/month

 

Claims for more than these amounts of drugs will be denied as not reasonable and necessary.

When a "concentrated form" of an inhalation drug is covered, separate saline solution (A4216 or A4218 [metered dose]) used to dilute it will be separately reimbursed. Saline dispensed for the dilution of concentrated nebulizer drugs must be billed on the same claim as the drug(s) being diluted. If the unit dose form of the drug is dispensed, separate saline solution (A4216 or A4218 [metered dose]), will be denied as not reasonable and necessary. Water or saline in 500 or 1000 ml quantities (A4217 or A7018) are not appropriate for use by beneficiaries to dilute inhalation drugs and will therefore be denied as not reasonable and necessary if used for this purpose. These codes are only reasonable and necessary when used in a large volume nebulizer (A7007, A7017, or E0585).

Albuterol, levalbuterol, and metaproterenol are all short-acting bronchodilators with beta-adrenergic stimulatory effect. It is not reasonable and necessary for a beneficiary to use more than one of these at a time. The use of more than one of these drugs at the same time will be denied as not reasonable and necessary.

Albuterol, levalbuterol, or metaproterenol is covered if it is used as a rescue/supplemental medication in addition to the long-acting beta-adrenergic agonist drug, formoterol or arformoterol.

Formoterol and arformoterol are long-acting bronchodilators with beta-adrenergic stimulatory effect. It is not reasonable and necessary for a beneficiary to use more than one of these at a time. The use of more than one of these drugs at the same time will be denied as not reasonable and necessary.

Revefenacin (J7677) is a long-acting muscarinic antagonist. Concurrent use of long-acting and short-acting muscarinic antagonists, such as ipratropium (J7644) is not reasonable and necessary. Therefore, if a long-acting muscarinic antagonist is used, the short-acting muscarinic antagonist will be denied as not reasonable and necessary.

Code J7620 describes the FDA-approved unit dose combination of albuterol base 2.5 mg and ipratropium bromide 0.5 mg in unit dose vials. The medical necessity for administering additional albuterol sulfate (J7611, J7613), levalbuterol (J7612, J7614) and/or ipratropium bromide (J7644) has not been established. Claims for J7611, J7612, J7613, J7614, and J7644 billed in addition to J7620 will be denied as not reasonable and necessary.

Charges for the drugs, diluent, and dispensing fees may only be billed by the entity that actually dispenses the drug to the Medicare beneficiary and that entity must be permitted under all applicable federal, state, and local laws and regulations to dispense drugs. Only entities licensed in the state where they are physically located may submit a claim for nebulizer drugs. Practitioners may submit a claim for drugs if all of the following conditions are met: the practitioner is 1) enrolled as a durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) supplier with the National Supplier Clearinghouse, and 2) dispensing the drug(s) to the Medicare beneficiary, and 3) authorized by the State to dispense drugs as part of the practitioner’s license. Claims submitted by entities not licensed to dispense drugs will be denied for lack of medical necessity.

GENERAL

A Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving a completed SWO, the claim shall be denied as not reasonable and necessary.

For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) base items that require a Written Order Prior to Delivery (WOPD), the supplier must have received a signed SWO before the DMEPOS item is delivered to a beneficiary. If a supplier delivers a DMEPOS item without first receiving a WOPD, the claim shall be denied as not reasonable and necessary. Refer to the LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.

For DMEPOS base items that require a WOPD, and also require separately billed associated options, accessories, and/or supplies, the supplier must have received a WOPD which lists the base item and which may list all the associated options, accessories, and/or supplies that are separately billed prior to the delivery of the items. In this scenario, if the supplier separately bills for associated options, accessories, and/or supplies without first receiving a completed and signed WOPD of the base item prior to delivery, the claim(s) shall be denied as not reasonable and necessary.

An item/service is correctly coded when it meets all the coding guidelines listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC articles. Claims that do not meet coding guidelines shall be denied as not reasonable and necessary/incorrectly coded.

Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. Proof of delivery documentation must be made available to the Medicare contractor upon request. All services that do not have appropriate proof of delivery from the supplier shall be denied as not reasonable and necessary.

REFILL REQUIREMENTS

For DMEPOS items and supplies provided on a recurring basis, billing must be based on prospective, not retrospective use. For DMEPOS products that are supplied as refills to the original order, suppliers must contact the beneficiary prior to dispensing the refill and not automatically ship on a pre-determined basis, even if authorized by the beneficiary. This shall be done to ensure that the refilled item remains reasonable and necessary, existing supplies are approaching exhaustion, and to confirm any changes or modifications to the order. Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date. For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product. This is regardless of which delivery method is utilized.

For all DMEPOS items that are provided on a recurring basis, suppliers are required to have contact with the beneficiary or caregiver/designee prior to dispensing a new supply of items. Suppliers must not deliver refills without a refill request from a beneficiary. Items delivered without a valid, documented refill request will be denied as not reasonable and necessary.

Suppliers must not dispense a quantity of supplies exceeding a beneficiary's expected utilization. Suppliers must stay attuned to changed or atypical utilization patterns on the part of their clients. Suppliers must verify with the treating practitioners that any changed or atypical utilization is warranted.

Regardless of utilization, a supplier must not dispense more than a three (3) - month quantity at a time.

DRUG WASTAGE

Claims for drugs billed to Medicare must use drug dosage formulations and/or unit dose sizes that minimize wastage. Medicare provides payment for the amount of a single use vial or other single use package of drug or biological discarded, in addition to the dose administered.

Effective for claims with dates of service on or after January 1, 2017, Medicare requires the use of the JW modifier when billing for drug wastage. Because of the HCPCS code descriptors and the associated UOS for DMEPOS items, the DME MACs expect rare use of the JW modifier on claims.

The amount of drug discarded must be billed on a separate claim line using the JW modifier. Review the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS section in the LCD-related Policy Article for additional instructions regarding the use of the JW modifier.

Effective for claims with dates of service on or after January 1, 2017, if the coverage criteria for the infusion drugs are not met, claims billed for drug wastage with the JW modifier will be denied as not reasonable and necessary.

Effective for claims with dates of service on or after January 1, 2017, claims lines billed for drug wastage without a JW modifier will be denied as not reasonable and necessary.

Summary of Evidence

Treprostinil Inhalation Solution for Pulmonary Hypertension due to Interstitial Lung Disease

Background

Pulmonary hypertension (PH) due to interstitial lung disease (ILD; PH-ILD) is classified as a Group 3 PH disorder by the World Health Organization (WHO). Interstitial lung diseases represent a heterogenous group of disorders that affect alveolar structures, pulmonary interstitium, and small airways leading to progressive scarring of the lungs. Approximately two-thirds of ILDs are idiopathic, with the idiopathic interstitial pneumonias (IIPs) being the most common entities.1 The prevalence of PH associated with ILD varies based on the underlying cause and the severity of the lung disease.2 Pulmonary hypertension due to ILD is associated with decreased exercise tolerance and quality of life (QoL), and increased need for supplemental oxygen, heart failure, and mortality.3 Treprostinil (Tyvaso) inhalation solution (United Therapeutics Corporation, Silver Springs, MD) is the first FDA approved treatment option for PH-ILD to improve exercise ability,4 and will be the focus of this portion of the analysis.

Treprostinil (Tyvaso) inhalation solution is a prostacyclin mimetic that is delivered using an ultrasonic, pulsed delivery device and is dosed in 4 separate, equally spaced treatment sessions per day, during waking hours, approximately 4 hours apart.5 On March 31, 2021, the U.S. Food & Drug Administration (FDA) granted supplemental approval for Tyvaso for the treatment of PH-ILD to improve exercise ability.4

Literature Analysis

In a multicenter, randomized, double-blind, placebo-controlled trial (INCREASE), Waxman, et al.3 aimed to determine the safety and efficacy of inhaled treprostinil for the treatment of PH-ILD. The primary end point was the difference in peak 6-minute walk distance from baseline to week 16. Patients with Group 3 PH confirmed by right heart catheterization (pulmonary vascular resistance of > 3 Wood units, pulmonary capillary wedge pressure of ≤15 mm Hg, mean pulmonary arterial pressure of ≥25 mm Hg), and who were able to walk at least 100 meters (m) during a 6-minute walk test were eligible for enrollment. A total of 326 patients (mean age 66.5 years, 46.9% female, 44.8% idiopathic interstitial pneumonia) were enrolled at 93 centers and were randomly assigned to receive placebo (163 patients) or inhaled treprostinil (163 patients). Forty patients assigned to receive inhaled treprostinil (24.5%) and 38 assigned to placebo (23.3%) discontinued the assigned regimen prematurely.

The mean difference in the change from baseline to peak 6-minute walk distance between the treprostinil group and the placebo group was 31.12 meters (95% confidence interval [CI], 16.85 to 45.39; p<0.001). Additionally, patients assigned to inhaled treprostinil showed significant improvements in multiple secondary end points including NT-proBNP levels (-15% vs. +46%, inhaled treprostinil vs. placebo; treatment ratio, 0.58; 95% CI, 0.47 to 0.72; p<0.001) and rate of clinical worsening (22.7% vs. 33.1%, inhaled treprostinil vs. placebo; hazard ratio, 0.61; 95% CI, 0.40 to 0.92; p=0.04). The most frequently reported adverse events (AEs) were mild to moderate in intensity and included cough, headache, dyspnea, dizziness, nausea, fatigue, and diarrhea. No serious AEs were reported significantly more frequently in the treprostinil group. Notably, significantly fewer patients in the treprostinil group had exacerbations of underlying lung disease (26.4% vs. 38.7%; p=0.02), and first occurrence of clinical worsening that involved hospitalization for a cardiopulmonary indication (11.0% vs. 14.7%; p=0.41). No deleterious effects on pulmonary function test variables were noted with treprostinil, and no significant treatment-related changes in pulse oximetry or supplemental oxygen use were noted in either treatment group.

Review of Iloprost or Treprostinil Inhalation Solution Coverage for Chronic Thromboembolic Pulmonary Hypertension

Background

Chronic thromboembolic pulmonary hypertension (CTEPH) is classified as a Group 4 PH disorder by the WHO and is thought to develop secondary to unresolved pulmonary embolism (PE) that scar and narrow the pulmonary vasculature. It is estimated that approximately 3% of acute PE survivors develop CTEPH.6 Underlying immunological, inflammatory or genetic mechanisms have been proposed as theories to explain why some patients develop CTEPH after an acute PE while others do not.7 Patients with CTEPH present with symptoms typical of PH, with progressive dyspnea, heart failure, and exercise intolerance. Pulmonary artery thromboendarterectomy is the definitive therapy of choice for CTEPH; however, in patients who are not candidates or who decline surgery, PH-specific therapy in combination with anticoagulation can be considered.8

Iloprost (Ventavis) is a prostacyclin mimetic that is delivered via a controlled dose inhalation drug delivery system 6-9 times per day. On December 29, 2004, the FDA granted approval for iloprost for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to improve a composite endpoint consisting of exercise tolerance, symptoms (NYHA Class), and lack of deterioration.9 In addition to the FDA indication for PH-ILD noted previously, treprostinil inhalation solution received FDA approval on July 30, 2009 for the treatment of PAH (WHO GROUP 1) to improve exercise ability.10 Neither iloprost nor treprostinil inhalation solution has an FDA approved indication for CTEPH (WHO Group 4). Of note, riociguat, a soluble guanylate cyclase stimulator, is currently the only FDA approved treatment for inoperable or persistent/recurrent CTEPH in the United States.11

 

Analysis of Evidence (Rationale for Determination)

Certainty of Evidence

Treprostinil Inhalation Solution for PH-ILD

Outcome(s)

Improved exercise capacity: High12,13

Iloprost or Treprostinil Inhalation Solution for CTEPH

N/A

 

Conclusion

Treprostinil Inhalation Solution for PH-ILD

In review of the currently available literature, there is high certainty evidence from a single, randomized, double blind, placebo-controlled trial that treprostinil inhalation solution safely improves exercise capacity in patients with PH-ILD in the short-term. Significantly fewer patients in the treprostinil group had exacerbations of their underlying lung disease and had fewer first occurrences of clinical worsening that involved hospitalization for a cardiopulmonary indication; however, these outcomes were not primary end points of the trial. Additionally, no long-term outcome data has been published. Despite the limited evidence, given the generally poor clinical course of PH-ILD and lack of any other approved therapeutic options, it is reasonable to extend coverage for treprostinil inhalation solution to Medicare beneficiaries with PH-ILD to improve exercise ability in those who meet the specified coverage criteria as will be outlined in the Nebulizers LCD (L33370) for this indication.

Review of Iloprost or Treprostinil Inhalation Solution Coverage for CTEPH

After a review of FDA indications for iloprost and inhaled treprostinil solution, neither drug has FDA approval for use in patients with CTEPH (WHO Group 4). Therefore, PH secondary to thromboembolic disease of the pulmonary arteries will be removed from the covered indications for iloprost and treprostinil inhalation solutions in the Nebulizers LCD (L33370). The ICD-10 tables in the LCD-related policy article will be updated to reflect this change.

Coding Information

CPT/HCPCS Codes

Group 1

(7 Codes)
Group 1 Paragraph

The appearance of a code in this section does not necessarily indicate coverage.

HCPCS MODIFIERS:

EY - No physician or other licensed health care provider order for this item or service

GA - Waiver of liability statement issued as required by payer policy, individual case

GZ - Item or service expected to be denied as not reasonable and necessary

JW - Drug amount discarded/not administered to any patient

KO - Single drug unit dose formulation

KP - First drug of a multiple drug unit dose formulation

KQ - Second or subsequent drug of a multiple drug unit dose formulation

KX - Requirements specified in the medical policy have been met

 

HCPCS CODES:

 

EQUIPMENT

Group 1 Codes
CodeDescription
E0565 COMPRESSOR, AIR POWER SOURCE FOR EQUIPMENT WHICH IS NOT SELF-CONTAINED OR CYLINDER DRIVEN
E0570 NEBULIZER, WITH COMPRESSOR
E0572 AEROSOL COMPRESSOR, ADJUSTABLE PRESSURE, LIGHT DUTY FOR INTERMITTENT USE
E0574 ULTRASONIC/ELECTRONIC AEROSOL GENERATOR WITH SMALL VOLUME NEBULIZER
E0575 NEBULIZER, ULTRASONIC, LARGE VOLUME
E0585 NEBULIZER, WITH COMPRESSOR AND HEATER
K0730 CONTROLLED DOSE INHALATION DRUG DELIVERY SYSTEM

Group 2

(18 Codes)
Group 2 Paragraph

ACCESSORIES

Group 2 Codes
CodeDescription
A4619 FACE TENT
A7003 ADMINISTRATION SET, WITH SMALL VOLUME NONFILTERED PNEUMATIC NEBULIZER, DISPOSABLE
A7004 SMALL VOLUME NONFILTERED PNEUMATIC NEBULIZER, DISPOSABLE
A7005 ADMINISTRATION SET, WITH SMALL VOLUME NONFILTERED PNEUMATIC NEBULIZER, NON-DISPOSABLE
A7006 ADMINISTRATION SET, WITH SMALL VOLUME FILTERED PNEUMATIC NEBULIZER
A7007 LARGE VOLUME NEBULIZER, DISPOSABLE, UNFILLED, USED WITH AEROSOL COMPRESSOR
A7008 LARGE VOLUME NEBULIZER, DISPOSABLE, PREFILLED, USED WITH AEROSOL COMPRESSOR
A7009 RESERVOIR BOTTLE, NON-DISPOSABLE, USED WITH LARGE VOLUME ULTRASONIC NEBULIZER
A7010 CORRUGATED TUBING, DISPOSABLE, USED WITH LARGE VOLUME NEBULIZER, 100 FEET
A7012 WATER COLLECTION DEVICE, USED WITH LARGE VOLUME NEBULIZER
A7013 FILTER, DISPOSABLE, USED WITH AEROSOL COMPRESSOR OR ULTRASONIC GENERATOR
A7014 FILTER, NONDISPOSABLE, USED WITH AEROSOL COMPRESSOR OR ULTRASONIC GENERATOR
A7015 AEROSOL MASK, USED WITH DME NEBULIZER
A7016 DOME AND MOUTHPIECE, USED WITH SMALL VOLUME ULTRASONIC NEBULIZER
A7017 NEBULIZER, DURABLE, GLASS OR AUTOCLAVABLE PLASTIC, BOTTLE TYPE, NOT USED WITH OXYGEN
A7525 TRACHEOSTOMY MASK, EACH
E0580 NEBULIZER, DURABLE, GLASS OR AUTOCLAVABLE PLASTIC, BOTTLE TYPE, FOR USE WITH REGULATOR OR FLOWMETER
E1372 IMMERSION EXTERNAL HEATER FOR NEBULIZER

Group 3

(59 Codes)
Group 3 Paragraph

INHALATION DRUGS AND SOLUTIONS

Group 3 Codes
CodeDescription
A4216 STERILE WATER, SALINE AND/OR DEXTROSE, DILUENT/FLUSH, 10 ML
A4217 STERILE WATER/SALINE, 500 ML
A4218 STERILE SALINE OR WATER, METERED DOSE DISPENSER, 10 ML
A7018 WATER, DISTILLED, USED WITH LARGE VOLUME NEBULIZER, 1000 ML
G0333 PHARMACY DISPENSING FEE FOR INHALATION DRUG(S); INITIAL 30-DAY SUPPLY AS A BENEFICIARY
J2545 PENTAMIDINE ISETHIONATE, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER 300 MG
J7604 ACETYLCYSTEINE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER GRAM
J7605 ARFORMOTEROL, INHALATION SOLUTION, FDA APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, 15 MICROGRAMS
J7606 FORMOTEROL FUMARATE, INHALATION SOLUTION, FDA APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, 20 MICROGRAMS
J7607 LEVALBUTEROL, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, CONCENTRATED FORM, 0.5 MG
J7608 ACETYLCYSTEINE, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER GRAM
J7609 ALBUTEROL, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE, 1 MG
J7610 ALBUTEROL, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, CONCENTRATED FORM, 1 MG
J7611 ALBUTEROL, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, CONCENTRATED FORM, 1 MG
J7612 LEVALBUTEROL, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, CONCENTRATED FORM, 0.5 MG
J7613 ALBUTEROL, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE, 1 MG
J7614 LEVALBUTEROL, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE, 0.5 MG
J7615 LEVALBUTEROL, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE, 0.5 MG
J7620 ALBUTEROL, UP TO 2.5 MG AND IPRATROPIUM BROMIDE, UP TO 0.5 MG, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME
J7622 BECLOMETHASONE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM
J7624 BETAMETHASONE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM
J7626 BUDESONIDE, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, UP TO 0.5 MG
J7627 BUDESONIDE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, UP TO 0.5 MG
J7628 BITOLTEROL MESYLATE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, CONCENTRATED FORM, PER MILLIGRAM
J7629 BITOLTEROL MESYLATE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM
J7631 CROMOLYN SODIUM, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER 10 MILLIGRAMS
J7632 CROMOLYN SODIUM, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER 10 MILLIGRAMS
J7634 BUDESONIDE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, CONCENTRATED FORM, PER 0.25 MILLIGRAM
J7635 ATROPINE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, CONCENTRATED FORM, PER MILLIGRAM
J7636 ATROPINE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM
J7637 DEXAMETHASONE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, CONCENTRATED FORM, PER MILLIGRAM
J7638 DEXAMETHASONE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM
J7639 DORNASE ALFA, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM
J7640 FORMOTEROL, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, 12 MICROGRAMS
J7641 FLUNISOLIDE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE, PER MILLIGRAM
J7642 GLYCOPYRROLATE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, CONCENTRATED FORM, PER MILLIGRAM
J7643 GLYCOPYRROLATE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM
J7644 IPRATROPIUM BROMIDE, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM
J7645 IPRATROPIUM BROMIDE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM
J7647 ISOETHARINE HCL, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, CONCENTRATED FORM, PER MILLIGRAM
J7650 ISOETHARINE HCL, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM
J7657 ISOPROTERENOL HCL, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, CONCENTRATED FORM, PER MILLIGRAM
J7660 ISOPROTERENOL HCL, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM
J7667 METAPROTERENOL SULFATE, INHALATION SOLUTION, COMPOUNDED PRODUCT, CONCENTRATED FORM, PER 10 MILLIGRAMS
J7669 METAPROTERENOL SULFATE, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER 10 MILLIGRAMS
J7670 METAPROTERENOL SULFATE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER 10 MILLIGRAMS
J7676 PENTAMIDINE ISETHIONATE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER 300 MG
J7677 REVEFENACIN INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, 1 MICROGRAM
J7680 TERBUTALINE SULFATE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, CONCENTRATED FORM, PER MILLIGRAM
J7681 TERBUTALINE SULFATE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM
J7682 TOBRAMYCIN, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, UNIT DOSE FORM, ADMINISTERED THROUGH DME, PER 300 MILLIGRAMS
J7683 TRIAMCINOLONE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, CONCENTRATED FORM, PER MILLIGRAM
J7684 TRIAMCINOLONE, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER MILLIGRAM
J7685 TOBRAMYCIN, INHALATION SOLUTION, COMPOUNDED PRODUCT, ADMINISTERED THROUGH DME, UNIT DOSE FORM, PER 300 MILLIGRAMS
J7686 TREPROSTINIL, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, 1.74 MG
J7699 NOC DRUGS, INHALATION SOLUTION ADMINISTERED THROUGH DME
Q0513 PHARMACY DISPENSING FEE FOR INHALATION DRUG(S); PER 30 DAYS
Q0514 PHARMACY DISPENSING FEE FOR INHALATION DRUG(S); PER 90 DAYS
Q4074 ILOPROST, INHALATION SOLUTION, FDA-APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, UP TO 20 MICROGRAMS

General Information

Associated Information

DOCUMENTATION REQUIREMENTS

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider.” It is expected that the beneficiary's medical records will reflect the need for the care provided. The beneficiary's medical records include the treating practitioner's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

GENERAL DOCUMENTATION REQUIREMENTS

In order to justify payment for DMEPOS items, suppliers must meet the following requirements:

  • SWO

  • Medical Record Information (including continued need/use if applicable)

  • Correct Coding

  • Proof of Delivery

Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information regarding these requirements.

Refer to the Supplier Manual for additional information on documentation requirements.

Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS

Items covered in this LCD have additional policy-specific requirements that must be met to justify Medicare reimbursement.

Refer to the LCD-related Policy article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information.

Miscellaneous

Appendices

Utilization Guidelines

Refer to Coverage Indications, Limitations and/or Medical Necessity

Sources of Information
N/A
Bibliography
  1. Raghu G, Nyberg F, Morgan G. The epidemiology of interstitial lung disease and its association with lung cancer. Br J Cancer. 2004;91 Suppl 2:S3-10.
  2. Nathan SD, Barbera JA, Gaine SP, et al. Pulmonary hypertension in chronic lung disease and hypoxia. Eur Respir J. 2019;53(1).
  3. Waxman A, Restrepo-Jaramillo R, Thenappan T, et al. Inhaled Treprostinil in Pulmonary Hypertension Due to Interstitial Lung Disease. N Engl J Med. 2021;384(4):325-334.
  4. U.S. Food & Drug Administration. Tyvaso Supplemental Approval Letter. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022387Orig1s017ltr.pdf. March 31, 2021. Accessed on May 3, 2021.
  5. U.S. Food & Drug Administration. Highlights of Prescribing Information Treprostinil Inhalation Solution (Tyvaso). https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022387s017lbl.pdf. Updated March 2021. Accessed May 3, 2021.
  6. Ende-Verhaar YM, Cannegieter SC, Vonk Noordegraaf A, et al. Incidence of chronic thromboembolic pulmonary hypertension after acute pulmonary embolism: a contemporary view of the published literature. Eur Respir J. 2017;49(2).
  7. Lang IM, Pesavento R, Bonderman D, Yuan JX. Risk factors and basic mechanisms of chronic thromboembolic pulmonary hypertension: a current understanding. Eur Respir J. 2013;41(2):462-468.
  8. Fedullo P, Kerr KM, Kim NH, Auger WR. Chronic thromboembolic pulmonary hypertension. Am J Respir Crit Care Med. 2011;183(12):1605-1613.
  9. U.S. Food & Drug Administration. Ventavis (iloprost) Approval Letter. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021779ltr.pdf. December 29, 2004. Accessed May 11, 2021.
  10. U.S. Food & Drug Administration. Tyvaso (treprostinil inhalation solution) Approval Letter. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022387s000ltr.pdf. July 30, 2009. Accessed May 12, 2021.
  11. U.S. Food & Drug Administration. Highlights of Prescribing Information Adempas (riociguat). https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204819s011lbl.pdf. Updated January 2018. Accessed May 13, 2021.
  12. GRADEpro GDT: GRADEpro Guideline Development Tool [Software]. McMaster University, 2015 (developed by Evidence Prime, Inc.). gradepro.org.
  13. Higgins JPT, Sterne JAC, Savovic J, et al. A revised tool for assessing risk of bias in randomized trials In: Chandler J, McKenzie J, Boutron I, Welch V (editors). Cochrane Methods. Cochrane Database of Systematic Reviews 2016, Issue 10 (Suppl 1). dx.doi.org/10.1002/14651858.CD201601.

Revision History Information

Revision History DateRevision History NumberRevision History ExplanationReasons for Change
06/05/2022 R9

Revision Effective Date: 06/05/2022
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Group 3 Codes reference for small volume nebulizer (A7003, A7004, A7005) and related compressor (E0570)
Revised: Language regarding coverage of E0574, to include administration of Treprostinil inhalation solution to beneficiaries with pulmonary hypertension only and reference to Group 11 Codes in the LCD-related PA
Revised: Coverage criteria for treprostinil and iloprost
Added: Separate criteria language for iloprost
Removed: Thromboembolic disease of the pulmonary arteries from criteria for treprostinil and iloprost
Added: Criterion 4 to treprostinil coverage criteria and reference to Group 11 Codes in the LCD-related PA
Added: Reference to Group 14 Codes in the LCD-related PA for iloprost
SUMMARY OF EVIDENCE:
Added: Information related to treprostinil inhalation solution for PH-ILD and related to iloprost and treprostinil inhalation solution for CTEPH
ANALYSIS OF EVIDENCE:
Added: Information related to treprostinil inhalation solution for PH-ILD and related to iloprost and treprostinil inhalation solution for CTEPH
BIBLIOGRAPHY:
Added: Section related to treprostinil inhalation solution for PH-ILD and related to iloprost and treprostinil inhalation solution for CTEPH
RELATED LOCAL COVERAGE DOCUMENTS:
Added: Response to Comments (A59085)

  • Provider Education/Guidance
  • Reconsideration Request
05/17/2020 R8

Revision Effective Date: 05/17/2020
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Added: Statement regarding base and related accessories and supplies (BPM Ch. 15, Section 110.3)
Clarified: “considered for coverage” to drug and equipment criteria
Added: Revefenacin to inhalation solutions for the management of obstructive pulmonary disease - For Dates of Service on or after 11/9/2018 (FDA Approval Date)
Revised: “alpha” to “alfa” in relation to HCPCS code J7639
Removed: Statement to refer to ICD-10 Codes that are Covered section in the LCD-related PA
Added: Statement to refer to ICD-10 codes in the LCD-related Policy Article
Revised: “alpha” to “alfa” in table with maximum milligrams/month
Added: Revefenacin to table with maximum milligrams/month
Added: Information regarding concurrent use of long-acting and short-acting muscarinic antagonists
Revised: Format of HCPCS code references, from code ‘spans’ to individually-listed HCPCS codes 
Revised: "physician" to "practitioner"
Revised: Order information as a result of Final Rule 1713
REFILL REQUIREMENTS:
Revised: "ordering physicians" to "treating practitioners" 
SUMMARY OF EVIDENCE:
Added: Information related to revefenacin
ANALYSIS OF EVIDENCE:
Added: Information related to revefenacin
HCPCS CODES:
Added: J7677 to Group 3 Codes in the HCPCS code table
CODING INFORMATION:
Removed: Field titled “Bill Type”
Removed: Field titled “Revenue Codes”
Removed: Field titled “ICD-10 Codes that Support Medical Necessity”
Removed: Field titled “ICD-10 Codes that DO NOT Support Medical Necessity”
Removed: Field titled “Additional ICD-10 Information”
GENERAL DOCUMENTATION REQUIREMENTS:
Revised: Prescriptions (orders) to SWO
BIBLIOGRAPHY:
Added: Section related to revefenacin
RELATED LOCAL COVERAGE DOCUMENTS:
Added: Response to Comments (A58035)

  • Provider Education/Guidance
  • Reconsideration Request
  • Other
01/01/2019 R7

Revision Effective Date: 01/01/2019
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Removed: Statements to refer to diagnosis code section below
Added: Refer to Covered ICD-10 Codes in the LCD-related Policy Article
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Moved: All diagnosis codes to the LCD-related Policy Article diagnosis code section per CMS instruction
ICD-10 CODES THAT DO NOT SUPPORT MEDICAL NECESSITY:
Moved: Statements about noncovered diagnosis codes moved to LCD-related Policy Article noncovered diagnosis code section per CMS instruction

  • Other (ICD-10 code relocation per CMS instruction)
10/01/2017 R6

Revision Effective Date: 10/01/2017

Coverage Indications, Limitations and/or Medical Necessity:
Update: References to ICD-10 Codes that Support Medical Necessity
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Added: New ICD-10 codes to Groups 11, 12, 13
Deleted: Non-valid ICD-10 codes from Group 11, 12, 13
Revised: ICD-10 code descriptions in Groups 2, 3, 7, 12, 13
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Update: Language to add “justify”, for Medicare reimbursement

10/26/2017: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Provider Education/Guidance
  • Revisions Due To ICD-10-CM Code Changes
01/01/2017 R5 Revision Effective Date: 01/01/2017
Removed: Standard Documentation Language
Added: New reference language and Directions to Standard Documentation Requirements
Added: General Requirements
Revised: Refill Requirements
Revised: Drug Wastage verbiage
DOCUMENTATION REQUIREMENTS:
Removed: Standard Documentation Language
Added: General Documentation Requirements
Added: New reference language and Directions to Standard Documentation Requirements
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Removed: Standard Documentation Language
Added: Directions to Standard Documentation Requirements
Removed: Information from Miscellaneous
Removed: PIM reference from Appendices
RELATED LOCAL COVERAGE DOCUMENTS:
Added: LCD-related Standard Documentation Requirements article
  • Provider Education/Guidance
07/01/2016 R4 Revision Effective Date: 07/01/2016
COVERAGE INDICATIONS, INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: Standard documentation language - ACA requirements – Effective 04/28/16
Added: A7007 and A7017 related accessories table for E0572
Added: Denial verbiage for JW Modifier when coverage criteria not met - Effective 01/01/17
HCPCS MODIFIERS:
Added: JW Modifier – Effective January 1, 2017
DOCUMENTATION REQUIREMENTS:
Revised: Standard documentation language for orders and ACA requirements, added New order requirements, and Correct coding instructions; revised Refill requirements to change "should" to "must", revised Proof of delivery instructions – Effective 04/28/16
Added: JW Modifier instructions – Effective January 1, 2017
  • Provider Education/Guidance
07/01/2016 R3 Effective July 1, 2016 oversight for DME MAC LCDs is the responsibility of CGS Administrators, LLC 18003 and 17013 and Noridian Healthcare Solutions, LLC 19003 and 16013. No other changes have been made to the LCDs.
  • Change in Assigned States or Affiliated Contract Numbers
01/01/2016 R2 Revision Effective Date: 01/01/2016
COVERAGE INDICATIONS, INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Deleted: HCPCS Code A7011 from Accessories tables
HCPCS CODES:
Deleted: HCPCS Code A7011
Added: HCPCS Code J7999
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Group 5 Codes:
Deleted: Code A7011 from the List of HCPCS codes
Group 7 Codes:
Added: ICD-10 Code E84.0 to Group 7 for J7608
DOCUMENTATION REQUIREMENTS:
Revised: Standard Documentation language to remove start date verbiage from Prescription Requirements (Effective 11/05/2015)
MISCELLANEOUS:
Deleted: Duplicative information about what is required on orders
Updated: HCPCS Code Q9977 cross-walked to J7999
Added: Standard product identification requirements for NOC codes
  • Provider Education/Guidance
  • Revisions Due To CPT/HCPCS Code Changes
  • Revisions Due To ICD-10-CM Code Changes
10/01/2015 R1 Revision Effective Date: 10/31/2014
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: Standard Documentation Language to add covered prior to a beneficiary’s Medicare eligibility
DOCUMENTATION REQUIREMENTS:
Revised: Standard Documentation Language to add who can enter date of delivery date on the POD
Added: Instructions for Equipment Retained from a Prior Payer
Revised: Repair to beneficiary-owned DMEPOS
MISCELLANEOUS:
Added: Instructions for HCPCS code Q9977 - Effective 07/01/2015
  • Provider Education/Guidance

Associated Documents

Attachments
N/A
Related National Coverage Documents
N/A
Public Versions
Updated On Effective Dates Status
04/14/2022 06/05/2022 - N/A Currently in Effect You are here
03/27/2020 05/17/2020 - 06/04/2022 Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

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