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 05/17/2020
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
04/02/2020
Notice Period End Date
05/16/2020
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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:

  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 only. Claims for code E0574 used with other inhalation solutions will be denied as not reasonable and necessary.

Treprostinil inhalation solution (J7686) and iloprost (Q4074) are 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 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, 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 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 E0574 and the related drug (J7686 for treprostinil) or code K0730 and the related drug (Q4074 for iloprost) 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 11 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.

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

Background

Revefenacin (Yupelri®) is a lung-specific, long-acting muscarinic antagonist (LAMA), also referred to as an anticholinergic. Revefenacin inhalation solution is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). The recommended dose of revefenacin inhalation solution is one 175 µg unit-dose vial administered once daily via a standard jet nebulizer. Revefenacin was approved by the Food & Drug Administration (FDA) on November 9, 2018 (see https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210598s000lbl.pdf).

Summary of Evidence

Several studies have examined the use of once-daily nebulized revefenacin in patients with moderate to severe or very severe COPD. In two (2) phase II, double-blinded, randomized, placebo-controlled, clinical trials,1 Quinn et al. demonstrated the rapid onset and sustained effect of bronchodilation with revefenacin for the treatment of COPD with adverse events (AEs) that were generally mild and occurred with similar frequencies in all groups.

In a 28 day safety and efficacy, randomized, double blinded, placebo-controlled parallel group, dose determination study, 2 Pudi et al. concluded that the use of revefenacin 88 and 175 µg doses in patients with COPD was supported over the sub-therapeutic 44 µg dose and the supra-therapeutic 350 µg dose.

Ferguson et al., in two (2) replicate 12-week, phase III, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group trials,3 characterized the efficacy, safety and tolerability of revefenacin 88 µg and 175 µg doses and demonstrated improvements in pulmonary function testing over 12-weeks. Revefenacin 175 µg dose demonstrated greater improvements in pulmonary function testing over the 88 µg dose, while maintaining a similar safety and tolerability profile.

Donohue et al. published two manuscripts4,5 on a 52-week phase III, randomized, partially double-blind, parallel group trial. One manuscript4 described the safety profile of revefenacin (88 μg and 175 μg) compared with tiotropium bromide (TIO). The overall incidence of AEs was generally similar between treatment groups. The revefenacin 175 μg dose was associated with lower AE rates than the 88 μg dose, and was highest in TIO treated patients. The second manuscript5 reported exploratory analyses on the efficacy and health outcomes endpoints, and use of rescue medication (albuterol) compared to baseline in participants. The data showed significant sustained improvements from baseline bronchodilation, respiratory health outcomes, and a trend towards a decrease in the use of rescue medication in the revefenacin 175 μg dose and TIO group over 52 weeks. The authors concluded that revefenacin was well tolerated over 1 year of treatment and demonstrated a safety and efficacy profile that supports its use as a long-term bronchodilator for COPD treatment.

Donohue et al. reported cardiac safety data6 that demonstrated revefenacin 88 and 175 μg had no clinically significant effect on measures of cardiac conductivity, and no increased risk of major cardiac AEs up to 52 weeks. The authors concluded that revefenacin may provide beneficial nebulized therapy for patients with COPD without further elevating their risk of cardiovascular events.

Analysis of Evidence (Rationale for Determination)

Level of evidence

Quality - Moderate

Strength - Moderate

Weight - Moderate

Muscarinic antagonists are generally accepted as effective, via their bronchodilation effects, in the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). Revefenacin is a long-acting muscarinic antagonist. There is sufficient evidence of safety and efficacy that revefenacin is comparable to other agents in its class, and to support extending coverage to include revefenacin for the maintenance treatment of COPD, when administered at a dose of 175µg once daily, via a standard hand-held nebulizer compressor.

Coding Information

CPT/HCPCS Codes

Group 1

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

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

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. Quinn D, Barnes CN, Yates W, et al. Pharmacodynamics, pharmacokinetics and safety of revefenacin (TD-4208), a long-acting muscarinic antagonist, in patients with chronic obstructive pulmonary disease (COPD): Results of two randomized, double-blind, phase 2 studies. Pulm Pharmacol Ther. 2018;48:71-79.
  2. Pudi KK, Barnes CN, Moran EJ, Haumann B, Kerwin E. A 28-day, randomized, double-blind, placebo-controlled, parallel group study of nebulized revefenacin in patients with chronic obstructive pulmonary disease. Respir Res. 2017;18(1):182.
  3. Ferguson GT, Feldman G, Pudi KK, et al. Improvements in Lung Function with Nebulized Revefenacin in the Treatment of Patients with Moderate to Very Severe COPD: Results from Two Replicate Phase III Clinical Trials. Chronic Obstructive Pulmonary Diseases (Miami, Fla). 2019;6(2).
  4. Donohue JF, Kerwin E, Sethi S, et al. Revefenacin, a once-daily, lung-selective, long-acting muscarinic antagonist for nebulized therapy: Safety and tolerability results of a 52-week phase 3 trial in moderate to very severe chronic obstructive pulmonary disease. Respiratory Medicine. 2019;153:38-43.
  5. Donohue JF, Kerwin E, Sethi S, et al. Maintained therapeutic effect of revefenacin over 52 weeks in moderate to very severe Chronic Obstructive Pulmonary Disease (COPD). Respir Res. 2019;20(1):241.
  6. Donohue JF, Feldman G, Sethi S, et al. Cardiovascular safety of revefenacin, a once-daily, lung-selective, long-acting muscarinic antagonist for nebulized therapy of chronic obstructive pulmonary disease: Evaluation in phase 3 clinical trials. Pulmonary Pharmacology & Therapeutics. 2019.
  7. Agusti A, Calverley PM, Celli B, et al. Characterisation of COPD heterogeneity in the ECLIPSE cohort. Respir Res. 2010;11:122.
  8. Baird C, Lovell J, Johnson M, Shiell K, Ibrahim JE. The impact of cognitive impairment on self-management in chronic obstructive pulmonary disease: A systematic review. Respir Med. 2017;129:130-139.
  9. Barr RG, Bourbeau J, Camargo CA, Ram FS. Tiotropium for stable chronic obstructive pulmonary disease: A meta-analysis. Thorax. 2006;61(10):854-862.
  10. Berlinski A. Assessing New Technologies in Aerosol Medicine: Strengths and Limitations. Respir Care. 2015;60(6):833-847; discussion 847-849.
  11. Bhatt SP, Dransfield MT. Chronic obstructive pulmonary disease and cardiovascular disease. Transl Res. 2013;162(4):237-251.
  12. Bollu V, Guerin A, Gauthier G, Hiscock R, Wu EQ. Readmission Risk in Chronic Obstructive Pulmonary Disease Patients: Comparative Study of Nebulized beta2-Agonists. Drugs Real World Outcomes. 2017;4(1):33-41.
  13. Bonini M, Usmani OSJCR, Practice. The importance of inhaler devices in the treatment of COPD. 2015;1(1):9.
  14. Dalal AA, Patel J, D'Souza A, Farrelly E, Nagar S, Shah M. Impact of COPD Exacerbation Frequency on Costs for a Managed Care Population. J Manag Care Spec Pharm. 2015;21(7):575-583.
  15. DePietro M, Gilbert I, Millette LA, Riebe M. Inhalation device options for the management of chronic obstructive pulmonary disease. Postgrad Med. 2018;130(1):83-97.
  16. Diette GB, Dalal AA, D'Souza AO, Lunacsek OE, Nagar SP. Treatment patterns of chronic obstructive pulmonary disease in employed adults in the United States. Int J Chron Obstruct Pulmon Dis. 2015;10:415-422.
  17. Fabbri LM, Luppi F, Beghe B, Rabe KF. Complex chronic comorbidities of COPD. Eur Respir J. 2008;31(1):204-212.
  18. Fingar K, Washington R. Trends in Hospital Readmissions for Four High-Volume Conditions, 2009-2013: Statistical Brief #196. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs. Rockville (MD)2006.
  19. Ford ES, Murphy LB, Khavjou O, Giles WH, Holt JB, Croft JB. Total and state-specific medical and absenteeism costs of COPD among adults aged >/= 18 years in the United States for 2010 and projections through 2020. Chest. 2015;147(1):31-45.
  20. Hanania NA, Braman S, Adams SG, et al. The Role of Inhalation Delivery Devices in COPD: Perspectives of Patients and Health Care Providers. Chronic Obstr Pulm Dis. 2018;5(2):111-123.
  21. Heo YA. Revefenacin: First Global Approval. Drugs. 2019;79(1):85-91.
  22. Hole DJ, Watt GC, Davey-Smith G, Hart CL, Gillis CR, Hawthorne VM. Impaired lung function and mortality risk in men and women: findings from the Renfrew and Paisley prospective population study. BMJ. 1996;313(7059):711-715; discussion 715-716.
  23. Kerstjens HA, Bantje TA, Luursema PB, et al. Effects of short-acting bronchodilators added to maintenance tiotropium therapy. Chest. 2007;132(5):1493-1499.
  24. Kunik ME, Roundy K, Veazey C, et al. Surprisingly high prevalence of anxiety and depression in chronic breathing disorders. Chest. 2005;127(4):1205-1211.
  25. Lau CS, Siracuse BL, Chamberlain RS. Readmission After COPD Exacerbation Scale: determining 30-day readmission risk for COPD patients. Int J Chron Obstruct Pulmon Dis. 2017;12:1891-1902.
  26. Lavorini F, Corrigan CJ, Barnes PJ, et al. Retail sales of inhalation devices in European countries: so much for a global policy. Respir Med. 2011;105(7):1099-1103.
  27. Leavitt BJ, Ross CS, Spence B, et al. Long-term survival of patients with chronic obstructive pulmonary disease undergoing coronary artery bypass surgery. Circulation. 2006;114(1 Suppl):I430-434.
  28. Loh CH, Peters SP, Lovings TM, Ohar JA. Suboptimal Inspiratory Flow Rates Are Associated with Chronic Obstructive Pulmonary Disease and All-Cause Readmissions. Ann Am Thorac Soc. 2017;14(8):1305-1311.
  29. Mahler DA. Peak Inspiratory Flow Rate: An Emerging Biomarker in COPD. Am J Respir Crit Care Med. 2019.
  30. Mahler DA. Peak Inspiratory Flow Rate as a Criterion for Dry Powder Inhaler Use in Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2017;14(7):1103-1107.
  31. Mascarenhas J, Lourenco P, Lopes R, Azevedo A, Bettencourt P. Chronic obstructive pulmonary disease in heart failure. Prevalence, therapeutic and prognostic implications. Am Heart J. 2008;155(3):521-525.
  32. Melani AS, Bonavia M, Cilenti V, et al. Inhaler mishandling remains common in real life and is associated with reduced disease control. Respir Med. 2011;105(6):930-938.
  33. Molimard M, Raherison C, Lignot S, et al. Chronic obstructive pulmonary disease exacerbation and inhaler device handling: real-life assessment of 2935 patients. Eur Respir J. 2017;49(2).
  34. Mylan. Yupelri (Revefenacin) Highlights of Prescribing Information. 2018; https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210598s001lbl.pdf.
  35. Nishi SPE, Maslonka M, Zhang W, Kuo YF, Sharma G. Pattern and Adherence to Maintenance Medication Use in Medicare Beneficiaries with Chronic Obstructive Pulmonary Disease: 2008-2013. Chronic Obstr Pulm Dis. 2018;5(1):16-26.
  36. Rootmensen GN, van Keimpema AR, Jansen HM, de Haan RJ. Predictors of incorrect inhalation technique in patients with asthma or COPD: a study using a validated videotaped scoring method. J Aerosol Med Pulm Drug Deliv. 2010;23(5):323-328.
  37. Singh D, Agusti A, Anzueto A, et al. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease: The GOLD Science Committee Report 2019. Eur Respir J. 2019.
  38. Suarez-Barcelo M, Micca JL, Clackum S, Ferguson GT. Chronic obstructive pulmonary disease in the long-term care setting: current practices, challenges, and unmet needs. Curr Opin Pulm Med. 2017;23 Suppl 1:S1-S28.
  39. Sulaiman I, Cushen B, Greene G, et al. Objective Assessment of Adherence to Inhalers by Patients with Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2017;195(10):1333-1343.
  40. Siu AL, Bibbins-Domingo K, Grossman DC, et al. Screening for Chronic Obstructive Pulmonary Disease: US Preventive Services Task Force Recommendation Statement. JAMA. 2016;315(13):1372-1377.
  41. Wise J. NICE recommends pulmonary rehabilitation programmes for patients with COPD. BMJ. 2016;352:i768.
  42. Wise RA, Acevedo RA, Anzueto AR, et al. Guiding Principles for the Use of Nebulized Long-Acting Beta2-Agonists in Patients with COPD: An Expert Panel Consensus. Chronic Obstr Pulm Dis. 2016;4(1):7-20.
  43. Yohannes AM, Chen W, Moga AM, Leroi I, Connolly MJ. Cognitive Impairment in Chronic Obstructive Pulmonary Disease and Chronic Heart Failure: A Systematic Review and Meta-analysis of Observational Studies. J Am Med Dir Assoc. 2017;18(5):451 e451-451 e411.
  44. Yohannes AM, Kaplan A, Hanania NA. COPD in Primary Care: Key Considerations for Optimized Management: Anxiety and Depression in Chronic Obstructive Pulmonary Disease: Recognition and Management. J Fam Pract. 2018;67(2 Suppl):S11-S18.
  45. Young RP, Hopkins R, Eaton TE. Forced expiratory volume in one second: not just a lung function test but a marker of premature death from all causes. Eur Respir J. 2007;30(4):616-622.
  46. Zarowitz BJ, O'Shea T. Chronic obstructive pulmonary disease: prevalence, characteristics, and pharmacologic treatment in nursing home residents with cognitive impairment. J Manag Care Pharm. 2012;18(8):598-606.

Revision History Information

Revision History DateRevision History NumberRevision History ExplanationReasons for Change
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
03/27/2020 05/17/2020 - N/A Currently in Effect You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

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