Department of Health and Human Services 

OFFICE OF 

INSPECTOR GENERAL 

EPLACEMENT CHEDULES 

FOR MEDICARE CONTINUOUS 

POSITIVE AIRWAY PRESSURE 

SUPPLIES 

Daniel R. Levinson 

Inspector General 

June 2013 

OEI-07-12-00250 

R S
 

EXECUTIVE SUMMARY: REPLACEMENT SCHEDULES FOR MEDICARE 

CONTINUOUS POSITIVE AIRWAY PRESSURE SUPPLIES 

OEI-07-12-00250 

WHY WE DID THIS STUDY 

Since 2009, the Office of Inspector General has identified reducing waste in health care services as a 

top management challenge for the Department of Health and Human Services (HHS). In 2012, 

HHS’s Centers for Medicare & Medicaid Services (CMS) found that beneficiaries receiving 

continuous positive airway pressure (CPAP) treatment for obstructive sleep apnea may have 

received more supplies (e.g., masks, tubing) than medically necessary; however, the quantities did 

not exceed the established replacement schedule. Providing more supplies than necessary may lead 

to wasteful spending. 

HOW WE DID THIS STUDY 

We requested CPAP replacement supply schedules in effect as of January 1, 2012, from 

50 fee-for-service State Medicaid programs and from 4 fee-for-service Federal Employees Health 

Benefits (FEHB) plans. We compared the replacement schedules for 15 types of CPAP supplies 

with Medicare’s schedules. Additionally, we collected recommended replacement schedules from 

five sleep disorder clinicians and four manufacturers. 

WHAT WE FOUND 

For supplies for which State Medicaid programs specified frequency schedules, 39 percent of 

frequencies were less than those under Medicare, and 51 percent equaled those under Medicare. 

Only 10 percent of frequencies exceeded those under Medicare. Additionally, many State Medicaid 

programs have either recently changed their schedules or have initiatives underway to do so. Two 

FEHB plans had no specific replacement schedules; the plans determined coverage on the basis of 

medical necessity. Sleep medicine clinicians emphasized the importance of proper mask fit, but 

research suggested that once proper mask fit is established, replacement of masks is less frequent 

than Medicare allows. Finally, manufacturers recommended specific replacement frequencies for 

only a few types of supplies, but those recommendations were often to replace those supplies on an 

as-needed basis and potentially less frequently than under Medicare’s replacement schedule. 

WHAT WE RECOMMEND 

We recommend that CMS review the CPAP supply replacement schedule and revise the national 

coverage determination or request that the Durable Medical Equipment Medicare Administrative 

Contractors revise their local coverage determinations as appropriate. CMS did not concur with our 

recommendation. CMS stated that failure to consider noncompliance or the potential impact of 

supplier fraud or abuse would bias the estimate of a clinically appropriate refill rate. Although our 

report does not include this specific information, we continue to believe that our evidence is 

sufficient to warrant the recommendation that CMS review the supply replacement schedule and 

make revisions as appropriate. 
TABLE OF CONTENTS 

Objective......................................................................................................1 

Background..................................................................................................1 

Methodology................................................................................................5 

Findings........................................................................................................8 

Medicare, other health insurers, sleep medicine clinicians, 

and CPAP manufacturers differ widely on replacement
 

frequencies for supplies ...................................................................8 

Conclusion and Recommendation .............................................................12 

Agency Comments and Office of Inspector General Response .....13 

Appendixes ................................................................................................14 

A: State Medicaid Program Replacement Schedules for 

Continuous Positive Airway Pressure Supplies .............................14 

B: Decreases in Medicare Expenditures for Masks If the 

Replacement Schedule Were Changed ..........................................16 

C: Agency Comments ...................................................................17 

Acknowledgments......................................................................................19 
 

 

OBJECTIVE 

To determine the extent to which the replacement schedule for continuous 

positive airway pressure (CPAP) supplies under Medicare’s fee-for-service 

system differed from those of other health insurers and the 

recommendations of clinicians and CPAP machine manufacturers. 

BACKGROUND 

Since 2009, the Office of Inspector General (OIG) has identified reducing 

waste in health care services as a top management challenge for the 

Department of Health and Human Services (HHS).1 In 2012, HHS’s 

Centers for Medicare & Medicaid Services (CMS) found that beneficiaries 

may have received more CPAP supplies than medically necessary;2 

however, the quantities did not exceed the established replacement 

schedule. Providing more supplies than necessary may lead to wasteful 

spending. 

The Medicare Prescription Drug, Improvement, and Modernization Act of 

20033 required that Medicare replace the existing fee-schedule payment 

methodology for selected durable medical equipment, prosthetics, 

orthotics, and supplies (DMEPOS) with a competitive-bid process. The 

purpose of competitive bidding was to improve the effectiveness of 

Medicare’s method of establishing DMEPOS payment amounts.4 

Although competitive bidding reduced the prices that Medicare paid for 

selected DMEPOS in selected areas, it did not change the frequency at 

which Medicare allows reimbursement for those items. 

In April 2012, CMS released a report on competitive bidding for 

DMEPOS, including CPAP supplies. As part of the review, CMS staff 

telephoned beneficiaries who had claims for CPAP replacement supplies 

prior to the inception of the competitive bidding program, but no claims 

for supplies thereafter. The beneficiaries reported that they had more than 

enough supplies on hand, often multiple months’ worth, and, therefore, did 

not need to obtain additional supplies after the competitive bidding 

program began. In its report, CMS concluded that this situation “suggests 

1

 OIG, Top Management and Performance Challenges. Accessed at https://oig.hhs.gov/
 

on October 18, 2012. 

2

 CMS, Competitive Bidding Update—One Year Implementation Update, p. 5, 

April 17, 2012. Accessed at http://www.cms.gov/ on April 27, 2012. 3 P.L. 108-173 § 302(b). 

4

 CMS, Overview of the DMEPOS Competitive Bidding Program. Accessed at 

http://www.dmecompetitivebid.com on November 1, 2012. 

Replacement Schedules for Medicare Continuous Positive Airway Pressure Supplies (OEI-07-12-00250) 1 
 

 

that beneficiaries received replacement supplies before they became 

medically necessary.”5 

CPAP 

Positive airway pressure, commonly administered by a CPAP machine, is 

the most widely used method for treating obstructive sleep apnea (OSA). 

Individuals diagnosed with OSA experience physical blockages or 

obstructions in the airway during sleep, usually because the back of the 

tongue collapses against the soft palate and the soft palate collapses 

against the back of the throat. A CPAP machine works by gently blowing 

pressurized air through a tube attached to a mask worn by the user. The 

pressurized air keeps the user’s throat open and acts as a sort of splint 

while the user sleeps.6 

Studies of the effect of positive airway pressure therapy show that OSA 

patients who consistently use their machines feel better and, as a result of 

the reduction of episodes of apnea during sleep, encounter fewer 

complications of the condition.7 However, the use of a CPAP machine is a 

form of continuous therapy for OSA patients and not a cure for OSA. 

Individuals will continue to use a CPAP machine indefinitely unless 

another intervention (e.g., weight loss) addresses the OSA.8 

Because of the continuous use, a variety of CPAP supplies—such as 

masks, tubing, chinstraps, and filters—must occasionally be replaced, thus 

incurring recurring expenses. For example, the mask material tends to 

absorb oil from the skin and may become stiff, needing to be replaced. In 

addition, some CPAP models have nonwashable air filters that require 

periodic replacement. 

Medicare Part B Coverage of CPAP Supplies 

Medicare Part B covers durable medical equipment (DME) as well as 

supplies and services that are essential to the effective use of the 

equipment. Medicare initially covers the cost of a CPAP machine for up 

to 12 weeks if the beneficiary’s OSA diagnosis is documented by a sleep 

5

 CMS, Competitive Bidding Update—One Year Implementation Update, p. 5, 

April 17, 2012. Accessed at http://www.cms.gov/ on April 27, 2012. 6

 American Sleep Apnea Association, Positive Airway Pressure Therapy. Accessed at 

http://sleepapnea.org/ on April 30, 2012. 7

 Ibid. 

8

 Nigel McArdle et. al., “Long-term Use of CPAP Therapy for Sleep Apnea/Hypopnea 

Syndrome.” American Journal of Respiratory and Critical Care Medicine, Vol. 159 

No. 4, pp. 1108–1114, April 1, 1999. Accessed at 

http://171.66.122.149/content/159/4/1108.abstract on March 12, 2012.
 

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study.9 Medicare covers the CPAP machine after the initial 12-week 

period for those beneficiaries diagnosed with OSA who benefit from 

CPAP during the initial 12-week period.10 

Through LCDs, each of the four DME MACs established identical CPAP 

supply replacement schedules.11 For example, DME MACs will reimburse 

a supplier for a CPAP mask (A7034) every 3 months and a nondisposable 

filter (A7039) every 6 months. Medicare will not pay for items or services 

that exceed this replacement schedule because they would not be 

considered “reasonable and necessary.”12 Table 1 lists the Healthcare 

Common Procedure Coding System (HCPCS) codes, correlating 

descriptions of CPAP replacement supplies, and the DME MACs’ 

determination of the maximum number of reasonable and necessary 

replacement of CPAP supplies. 

9

 CMS, “Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep 

Apnea (OSA),” Medicare National Coverage Determinations Manual, Pub. 100-03, 

§ 240.4. Accessed at http://www.cms.gov/ on March 12, 2012. Medicare also provides 

limited coverage for CPAP machines for beneficiaries enrolled in certain clinical studies. 10 Ibid. CMS may establish national coverage determinations (NCD) for DMEPOS. 

NCDs specify whether certain medical items, services, treatment procedures, or 

technologies are eligible for Medicare payment. When an NCD does not exist or when 

there is need for further definition, a local coverage determination (LCD) may be 

established by a CMS contractor. Through LCDs, each of the four Durable Medical 

Equipment Medicare Administrative Contractors (DME MAC) established minimum 

utilization criteria that must be met to establish that beneficiaries are benefiting from 

CPAP therapy. If the criteria are not met, continued coverage of a CPAP machine and 

related supplies will be denied as not reasonable and necessary. (See LCD numbers 

listed in footnote 11.) 

11 The four DME MACs and their respective LCD numbers for CPAP replacement 

supplies are CIGNA Government Services (L11518), National Government Services 

(L27230), National Heritage Insurance Company (L11504), and Noridian Administrative 

Services (L171). 

12 Social Security Act (SSA), § 1862(a)(1)(A). 

Replacement Schedules for Medicare Continuous Positive Airway Pressure Supplies (OEI-07-12-00250) 3 
 

Table 1: DME MACs’ Determination of Reasonable and Necessary 

Replacement of CPAP Supplies 

HCPCS 

Code Description Frequency 

A4604 CPAP Tubing With Heating Element 1 per 3 months 

A7027 Combination Oral/Nasal CPAP Mask 1 per 3 months 

A7028 Replacement Oral Cushion for Oral/Nasal Mask 2 per 1 month 

A7029 Replacement Nasal Pillows for Oral/Nasal Mask, One Pair 2 per 1 month 

A7030 Full Face Mask 1 per 3 months 

A7031 Full Face Mask Interface 1 per 1 month 

A7032 Cushion for Nasal Mask Interface 2 per 1 month 

A7033 Nasal Pillows 2 per 1 month 

A7034 Nasal Interface 1 per 3 months 

A7035 Headgear 1 per 6 months 

A7036 Chinstrap 1 per 6 months 

A7037 Tubing 1 per 3 months 

A7038 Disposable Filter 2 per 1 month 

A7039 Nondisposable Filter 1 per 6 months 

A7046 Humidifier Water Chamber 1 per 6 months 

Source: DME MAC LCDs: CIGNA Government Services (L11518) dated February 4, 2011; National 

Government Services (L27230) dated October 1, 2011; National Heritage Insurance Company (L11504) 

dated February 4, 2011; and Noridian Administrative Services (L171) dated October 1, 2011. 

The LCDs were first issued in 1993. At that time, medical review staff at 

DME claims payment contractors contacted CPAP manufacturers and 

clinicians to ask questions about the length of time that supplies were 

expected to last. Supply frequencies were established on the basis of these 

contacts. With one exception (i.e., tubing), the replacement frequencies 

have remained the same for the past 20 years. 

Related Report 

A 2012 study of Veterans Healthcare Administration (VHA) patients with 

OSA receiving positive airway pressure therapy for more than 1 year 

found that CPAP supply refill rates were much greater in adherent patients 

Replacement Schedules for Medicare Continuous Positive Airway Pressure Supplies (OEI-07-12-00250) 4 
 

 

 

 

 

than in nonadherent patients.13 Researchers selected a study population of 

patients receiving positive airway pressure therapy for more than 1 year 

because replacement rates, particularly for masks, can be more frequent 

during the first year of use. During the initial period of use, patients might 

need to try several masks to find the proper fit.14 Researchers found that 

the rates at which patients replaced supplies were a good predictor of 

long-term adherence to positive airway pressure therapy. 

METHODOLOGY 

Scope 

We limited our study to the replacement schedules in effect as of 

January 1, 2012, for the 15 types of CPAP supplies listed on DME MAC 

LCDs. To ensure equitable comparisons, we compared the supply 

replacement schedules and methods for establishing those schedules only 

to those of other fee-for-service health insurers. Of the 15 types of CPAP 

supplies, masks (A7027, A7030, and A7034) have the highest per-unit fee 

schedule reimbursement amounts under the Medicare fee schedule. The 

2012 fee schedule amounts for the three types of CPAP masks ranged from 

$108.90 to $209.57 depending on the type of mask and geographic 

jurisdiction. In 2011, masks accounted for 48 percent of the total 

expenditures for CPAP supplies. Therefore, we calculated the effects of 

replacement schedule changes only for masks rather than for all 15 types 

of CPAP supplies. 

We did not determine the validity of the diagnoses that led to the initial 

prescription for a CPAP machine, nor did we determine the medical 

necessity of the CPAP machine for the patients. Our review covered the 

replacement schedules and did not include the fee schedules or 

reimbursement rates paid by health insurers. 

13 Nimesh Patel, D.O.; Afshin Sam, M.D.; Alexandra Valentin, RRT; Stuart F. Quan, 

M.D; and Sairam Parthasarathy, M.D. “Refill Rates of Accessories for Positive Airway 

Pressure Therapy as a Surrogate Measure of Long-Term Adherence.” Journal of Clinical 

Sleep Medicine, Vol. 8, No. 2, 2012, pp. 169–175. This study defined “adherence” using 

a modified version of the compliance criteria set forth in the LCDs of the four DME 

MACs. For three of the four DME MACs—CIGNA Government Services, National 

Government Services, and Noridian Administrative Services—“adherence” is defined as 

use of the machine for at least 4 hours per night on 70 percent of nights during a 

consecutive 30-day period anytime during the first 3 months of use. For the remaining 

DME MAC—National Heritage Insurance Company—“adherence” is defined as an 

average of 4 hours of use per 24-hour period on or after 61 days of initiation of CPAP 

therapy. 

14 National Institutes of Health, National Heart, Lung, and Blood Institute. Accessed at 

http://www.nhlbi.nih.gov on February 11, 2013. 

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Data Collection 

We requested CPAP replacement supply schedules in effect as of 

January 1, 2012, from 50 fee-for-service State Medicaid programs and 

from 4 fee-for-service Federal Employees Health Benefits (FEHB) plans.15 

These four FEHB plans provide coverage to 93 percent of fee-for-service 

FEHB enrollees. We surveyed each of the State Medicaid programs and 

the selected FEHB plans to ascertain how they formulated their supply 

replacement schedules. 

We also collected recommended replacement schedules from clinicians 

and manufacturers. To obtain clinician recommendations, we contacted 

the director of the National Center on Sleep Disorders Research in the 

National Heart, Lung, and Blood Institute’s Division of Lung Diseases at 

the National Institutes of Health. The director provided the contact 

information for five sleep disorder clinicians who also conduct sleep apnea 

research in academic settings. We conducted structured interviews with 

these five clinicians to obtain their recommendations. Additionally, we 

surveyed four manufacturers of CPAP machines to determine their 

recommended replacement supply schedules.16 

Data Analysis 

Replacement Schedule Comparisons. Medicare, State Medicaid programs, 

and FEHB plans state the frequencies of replacement supplies in varying 

timeframes. For example, Medicare states the replacement frequency for 

masks as 1 per 3 months and the replacement frequency for disposable 

filters as 2 per 1 month. To perform equitable comparisons, we converted 

all frequency schedules to annual frequencies (e.g., 4 masks per year, 

24 disposable filters per year), although health insurers reimburse for 

supplies according to the stated frequency. 

Effects of Replacement Schedule Changes. To calculate the effects of 

potential changes to replacement schedules on the Medicare program, we 

used the population of Medicare claims from 2011 for three types of CPAP 

masks: A7027, A7030, and A7034. To identify mask claims for 

beneficiaries using machines for more than 1 year, we excluded masks for 

beneficiaries who also had claims for positive airway pressure machines 

(i.e., E0470, E0471, E0472, and E0601) during 2010 and 2011. Using this 

approach enabled us to better identify the claims for masks that were 

15 Staff from the Tennessee Medicaid program stated that 100 percent of recipients are 

enrolled in managed care plans; therefore, Tennessee does not pay for CPAP supplies on 

a fee-for-service basis. We did not include the Tennessee Medicaid program in our data 

collection but included the District of Columbia, for a total of 50 State Medicaid 

programs. 

16 The four manufacturers are DeVilbiss Healthcare, Fisher & Paykel, 

Philips/Respironics, and ResMed. 

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replacements versus claims for masks that beneficiaries received to ensure 

proper fit. Table 2 shows the number of beneficiaries with claims for 

masks in 2011 who did not have claims for machines during 2010 and 

2011. 

Table 2: 2011 Mask Claims for Beneficiaries Using CPAP Machines for More Than 

1 Year 

Number 

of Masks 

A7027 A7030 A7034 

Number of 

Beneficiaries 

Allowed 

Dollars 

Number of 

Beneficiaries 

Allowed 

Dollars 

Number of 

Beneficiaries 

Allowed 

Dollars 

1 3,074 $589,420 92,075 $15,478,300 179,456 $18,752,549 

2 857 $328,486 41,072 $13,831,501 80,697 $16,881,285 

3 354 $203,872 20,681 $10,464,637 38,331 $12,036,781 

4 139 $106,620 8,510 $5,749,508 16,126 $6,765,351 

5 1 $941 245 $207,358 340 $176,731 

6 N/A N/A 54 $55,258 58 $35,273 

7 N/A N/A 13 $15,220 26 $19,356 

8 N/A N/A 8 $10,915 8 $6,806 

9 N/A N/A 1 $1,535 3 $2,871

 Total 4,425 $1,229,339 162,659 $45,814,232 315,045 $54,677,003 

Note: Although DME MAC LCDs have determined that one mask per 3 months is the maximum reasonable and necessary quantity, 

Medicare beneficiaries can appeal for the reimbursement of additional claims. 

Dollar amounts are rounded to the nearest $1. 

Source: Medicare National Claims History File, 2012. 

Although Medicare allows up to four masks per year, the majority of 

beneficiaries received only one or two. Not all beneficiaries replaced 

supplies at the coverage policy’s maximum amount. It is expected that 

beneficiaries whose clinical conditions do not require the maximum 

quantities should receive only the quantities that they need. Medicare 

does not pay for items or services which are not reasonable and necessary 

for the diagnosis or treatment of illness or injury.17 

Standards 

This study was conducted in accordance with the Quality Standards for 

Inspection and Evaluation issued by the Council of the Inspectors General 

on Integrity and Efficiency. 

17 SSA, § 1862(a)(1)(A). 

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FINDINGS 

Medicare, other health insurers, sleep medicine 

clinicians, and CPAP manufacturers differ widely on 

replacement frequencies for supplies 

Seventy-four percent of State Medicaid programs had 

replacement schedules for CPAP supplies; 39 percent of these 

schedules permitted replacement less frequently than did 

Medicare 

Thirty-seven of 50 State Medicaid programs (74 percent) reported that 

they had replacement schedules for CPAP supplies in effect as of 

January 1, 2012. Of the 13 State Medicaid programs that reported having 

no replacement schedules, 9 programs reported that supplies were replaced 

on the basis of medical necessity.18 The remaining four programs 

(Arkansas, Florida, New Jersey, and Rhode Island) reported that the 

monthly reimbursement for the rental of the CPAP machine included all 

necessary supplies. Because these four States did not use replacement 

schedules, we did not further explore the costs associated with 

continuously renting this equipment. 

For the 37 State Medicaid programs that had replacement supply 

schedules, we compared the frequency of replacement for each of the 

15 types of supplies with that of Medicare.19 For those supplies for which 

State Medicaid programs specified replacement frequency schedules, 

39 percent of frequencies were less than those under Medicare, 51 percent 

equaled those under Medicare, and 10 percent exceeded those under 

Medicare. Table 3 shows the range of State Medicaid program 

replacement frequencies and Medicare’s frequencies for all types of 

supplies reviewed. 

18 State Medicaid programs did not provide a specific definition of “medical necessity.” 

19 Not all of the State Medicaid programs had replacement frequencies for each of the 

15 types of supplies. 

Replacement Schedules for Medicare Continuous Positive Airway Pressure Supplies (OEI-07-12-00250) 8 
 

Table 3: Comparison of State Medicaid Programs’ and Medicare’s 

Replacement Schedules for CPAP Supplies 

HCPCS 

Code Description 

Annual Frequency of Replacement 

Lowest 

State 

Medicaid 

Program

Frequency 

Highest 

State 

Medicaid 

Program

Frequency 

Medicare 

Frequency 

A4604 CPAP Tubing With Heating Element 1 24 4 

A7027 Combination Oral/Nasal CPAP Mask 1 12 4 

A7028 Replacement Oral Cushion for 

Oral/Nasal Mask 1 24 24 

A7029 Replacement Nasal Pillows for 

Oral/Nasal Mask, One Pair 

1 24 24 

A7030 Full Face Mask 1 per 

5 years 12 4 

A7031 Full Face Mask Interface 1 12 12 

A7032 Cushion for Nasal Mask Interface 1 24 24 

A7033 Nasal Pillows 1 24 24 

A7034 Nasal Interface 1 per 

5 years 

24 4 

A7035 Headgear 1 12 2 

A7036 Chinstrap 1 12 2 

A7037 Tubing 1 12 4 

A7038 Disposable Filter 4 72 24 

A7039 Nondisposable Filter 1 12 2 

A7046 Humidifier Water Chamber 1 per 

3 years 

12 2 

Note: We converted reported frequencies to annual frequencies. 

Source: OIG analysis of State Medicaid program survey responses, 2012.
 

The replacement frequencies for all 37 State Medicaid programs can be 

found in Appendix A. 

Many State Medicaid Programs Have Changed or Have Initiatives 

Underway To Change CPAP Supply Replacement Schedules. Medicare’s 

CPAP supply replacement frequency schedule has remained largely the 

same for the past 20 years; however, many State Medicaid programs have 

either recently changed their schedules or have initiatives underway to do 

so. Eight State Medicaid programs made changes to their schedules 

between 2009 and 2011. For example, in October 2009, the New York 

Medicaid program changed the allowed replacement frequency for 

nondisposable filters without prior approval from three filters every 

2 months to two filters every 6 months. 

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Another 10 State Medicaid programs reported that they had initiatives 

underway to change the replacement schedules for CPAP supplies. For 

example, four States were reviewing their policies for CPAP supplies. 

Another three States will address CPAP supply replacement frequencies in 

conjunction with the implementation of new Medicaid management 

information systems. 

Medicare Expenditures for Masks Could Be Less If the Replacement 

Schedule Were Changed To Match Selected State Medicaid Program 

Schedules. We calculated the effects of Medicare expenditures for CPAP 

masks if Medicare changed its schedule to those of selected State 

Medicaid programs. Two State Medicaid programs (Minnesota and 

Virginia) used replacement schedules that allowed one mask replacement 

per 4 months. Six State Medicaid programs used replacement schedules 

that allowed one mask replacement per 6 months.20 Appendix B shows the 

potential reductions in Medicare expenditures if Medicare changed its 

replacement schedule for masks. We note that, regardless of the number 

of mask replacements allowed, an important aspect of cost control is to 

ensure that beneficiaries receive only the quantities sufficient to meet the 

needs of their clinical conditions. 

Two FEHB plans followed Medicare’s replacement schedule 

and two plans had no specific schedules 

Of the four FEHB plans that we surveyed, two plans reported that they 

followed Medicare’s replacement schedule for CPAP supplies and the 

other two plans had not established specific schedules. The two plans that 

followed Medicare’s schedule further stated that they would consider 

exceptions for circumstances such as improperly fitted or worn supplies in 

allowing CPAP supplies in greater quantity or frequency. The other two 

plans stated that they did not limit the frequency of replacement of 

supplies; instead, the plans determined coverage on the basis of medical 

necessity.21 

Clinicians emphasized the importance of proper mask fit; 

clinical research suggested that once proper mask fit is 

established, replacement is less frequent than Medicare allows 

All five of the sleep disorder medicine clinicians with whom we spoke 

emphasized that proper mask fit is an important factor in achieving patient 

adherence with CPAP therapy. During the first year, and particularly 

20 The six State Medicaid programs are Alabama, Georgia, Hawaii, Missouri, North 

Carolina, and North Dakota. Alabama and Hawaii specified a replacement frequency of 

two masks per year for only two of the three types of masks (i.e., A7030 and A7034). 

21 FEHB plans did not provide a specific definition of “medical necessity.” 

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within the initial 3-month period of use, patients may need to try several 

types or brands of masks to find the best fit. 

One clinician characterized Medicare’s CPAP supply replacement 

schedule as “generous.” Another clinician recommended that replacing 

masks once every 4 months (3 per year) was sufficient. Finally, two 

clinicians commented that the material used in some supplies (e.g., tubing) 

is becoming more durable, necessitating less frequent replacement. 

The fifth clinician conducted research on VHA patients receiving positive 

airway pressure therapy for more than 1 year. This clinician found that 

supply replacement rates were much greater in adherent patients than in 

nonadherent patients.22 The median refill rate of all supplies combined 

(e.g., masks, tubing, filters) for adherent patients was 1.5 items per year. 

The median replacement rate for masks alone was 0.67 per year for 

adherent patients—less than 1 mask per year (as compared to Medicare’s 

allowed frequency of 1 per 3 months). We note that VHA does not have a 

replacement schedule for CPAP supplies. Instead, replacements are 

provided upon patient request. 

Manufacturers recommended specific replacement 

frequencies for only a few types of supplies 

Three of the four CPAP machine manufacturers that we surveyed 

recommended specific replacement frequencies for certain supplies. In 

those cases, manufacturers’ recommended frequencies were equal to or 

less frequent than those under Medicare’s schedule. Most commonly, 

manufacturers had replacement frequency recommendations for filters 

(i.e., A7038, A7039). However, instead of specific frequency 

recommendations, each of the manufacturers commented that the 

frequency of replacement was variable and was based on individual use, 

method and frequency of cleaning, and the environment in which the 

CPAP equipment was used. For example, one manufacturer recommended 

replacing a mask if it “became weakened or cracked.” Another 

manufacturer that had no specific recommendation for the frequency of 

replacing filters commented that a filter should be replaced “if it shows 

signs of dirt or damage.” 

22 Nimesh Patel, D.O.; Afshin Sam, M.D.; Alexandra Valentin, RRT; Stuart F. Quan, 

M.D; and Sairam Parthasarathy, M.D. “Refill Rates of Accessories for Positive Airway 

Pressure Therapy as a Surrogate Measure of Long-Term Adherence.” Journal of 

Clinical Sleep Medicine, Vol. 8, No. 2, 2012, pp. 169-175. 

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CONCLUSION AND RECOMMENDATION 

Medicare, other health care insurers, sleep medicine clinicians, and CPAP 

manufacturers differ widely on replacement frequencies for supplies. For 

supplies for which State Medicaid programs specified replacement 

frequency schedules, 39 percent of frequencies were less than those under 

Medicare and 51 percent equaled those under Medicare. Only 10 percent 

exceeded those of Medicare. Additionally, many State Medicaid programs 

have either recently changed their schedules or have initiatives underway 

to do so. Two FEHB plans had no specific replacement schedules; the 

plans determined coverage on the basis of medical necessity. Sleep 

medicine clinicians emphasized the importance of proper mask fit, but 

research suggested that once proper mask fit is established, replacement of 

masks is less frequent than Medicare allows. Finally, manufacturers 

recommended specific replacement frequencies for only a few types of 

supplies, but those recommendations were often to replace those supplies 

on an as-needed basis and potentially less frequently than Medicare’s 

replacement schedule. 

CPAP supplies are included in one product category of CMS’s 

competitive-bid process, which began for limited categories of DMEPOS 

in 2011. First year savings for this category totaled over $19 million. 

However, competitive bidding does not address replacement schedules, 

and Medicare’s CPAP supply replacement frequency schedule has 

remained largely the same for the past 20 years. 

We recommend that CMS: 

Review the CPAP Supply Replacement Schedule and Revise 

the National Coverage Determination for CPAP Therapy for 

OSA or Request That the DME MACs Revise Their LCDs as 

Appropriate 

We present evidence from State Medicaid programs and clinicians that 

supports less frequent replacement than what Medicare allows. We also 

present suggestions from respondents to replace supplies on an as-needed 

basis. CMS could consider allowing a more generous schedule for CPAP 

machine users during the first year of use and a less frequent replacement 

schedule for established users. If CMS deems revision of the CPAP 

supply replacement schedule to be warranted, it should revise its NCD to 

include an appropriate CPAP supply replacement schedule and ensure that 

the DME MACs make corresponding changes to their LCDs. 

Alternatively, CMS could request that the DME MACs revise their LCDs. 

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AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 

RESPONSE 

CMS did not concur with our recommendation. CMS stated that 

additional information specific to CPAP use among adherent beneficiaries 

as well as that related to Medicare suppliers should be explored before any 

recommendations are provided. CMS also stated that failure to consider 

noncompliance or the potential impact of supplier fraud or abuse would 

bias the estimate of a clinically appropriate refill rate. Although our report 

does not include this specific information, we continue to believe that our 

evidence is sufficient to warrant the recommendation that CMS review the 

supply replacement schedule and make revisions as appropriate. We agree 

that CMS will likely set more accurate rates if the additional information 

referenced above is obtained. 

We did not make any changes to the report based on CMS’s comments. 

The full text of CMS’s comments is provided in Appendix C. 

Replacement Schedules for Medicare Continuous Positive Airway Pressure Supplies (OEI-07-12-00250) 13 
 

 

APPENDIX A 

State Medicaid Program Replacement Schedules for 

Continuous Positive Airway Pressure Supplies 

State 

Annual Frequency of Replacement 

A4604 A7027 A7028 A7029 A7030 A7031 A7032 

Alabama N/A N/A N/A N/A 2 2 2 

California 2 1 12 24 1 1 12 

Connecticut 12 12 24 24 12 12 24 

Delaware 4 N/A N/A N/A 2 2 24 

District of Columbia 4 4 4 4 4 4 4 

Georgia N/A 2 12 12 2 1 12 

Hawaii 24 N/A N/A N/A 2 2 2 

Idaho 4 4 24 24 4 12 24 

Illinois 2 2 2 3 2 1 12 

Iowa 4 4 24 24 4 12 24 

Kansas 1 1 1 1 1 1 1 

Louisiana 4 N/A N/A N/A 4 12 24 

Maine 12 4 24 24 4 12 24 

Maryland 1 4 24 24 12 12 24 

Massachusetts N/A 4 6 6 4 12 24 

Michigan N/A 1 1 1 1 1 1 

Minnesota 4 3 12 12 3 12 12 

Mississippi N/A N/A N/A N/A 4 4 12 

Missouri N/A 2 2 6 2 2 2 

Montana 4 4 24 24 4 12 24 

Nebraska N/A 4 24 N/A 4 12 24 

Nevada 4 4 24 24 4 12 24 

New Mexico 4 4 24 24 4 4 24 

New York N/A 2 2 2 1 per 5 years 2 2 

North Carolina N/A 2 2 2 2 2 2 

North Dakota 12 2 24 24 2 12 24 

Ohio N/A N/A N/A N/A 1 N/A 2 

Oklahoma N/A 1 1 1 1 1 1 

Oregon 4 4 24 24 4 12 24 

Pennsylvania 4 4 24 24 2 4 12 

South Carolina 2 1 1 1 2 2 2 

Texas N/A 4 12 24 4 12 24 

Utah N/A N/A 1 1 1 1 1 

Vermont 4 4 24 12 4 12 24 

Virginia 12 3 3 3 3 3 3 

Washington 2 N/A N/A N/A 2 4 2 

West Virginia 12 N/A N/A N/A 2 2 24 

Note: We converted reported frequencies to annual frequencies. “N/A” indicates that no replacement frequency was reported for that supply. 

State Medicaid programs may make exceptions to these replacement schedules based on medical necessity. 

continued on next page 

Replacement Schedules for Medicare Continuous Positive Airway Pressure Supplies (OEI-07-12-00250) 14 
 

 

State Medicaid Program Replacement Schedules for 

Continuous Positive Airway Pressure Supplies (Continued) 

State 

Annual Frequency of Replacement 

A7033 A7034 A7035 A7036 A7037 A7038 A7039 A7046 

Alabama 2 2 2 2 1 12 2 2 

California 24 2 2 2 2 24 2 2 

Connecticut 24 12 12 12 12 24 12 12 

Delaware 24 4 2 2 4 12 N/A N/A 

District of Columbia 4 4 4 4 4 4 4 4 

Georgia 12 2 2 2 12 12 2 1 per 3 years 

Hawaii 4 2 1 1 2 4 1 2 

Idaho 24 4 2 2 4 12 2 2 

Illinois 12 4 2 2 2 24 2 3 

Iowa 24 4 2 2 4 24 2 2 

Kansas N/A N/A 1 1 1 N/A 1 1 

Louisiana 24 4 2 2 12 24 2 2 

Maine 24 24 2 2 12 24 2 12 

Maryland 24 4 2 2 4 24 12 2 

Massachusetts 24 4 2 2 4 6 2 2 

Michigan 1 1 1 1 1 18 N/A 2 

Minnesota 12 3 3 2 12 36 3 4 

Mississippi 12 4 2 2 12 24 2 N/A 

Missouri 6 2 2 2 2 24 2 N/A 

Montana 24 4 2 2 4 24 2 2 

Nebraska 24 N/A N/A N/A N/A N/A N/A N/A 

Nevada 24 4 2 2 4 24 2 2 

New Mexico 24 4 4 2 4 24 12 2 

New York 2 1 per 5 years 2 2 2 4 4 N/A 

North Carolina 2 2 2 1 2 12 6 N/A 

North Dakota 24 2 2 2 12 24 2 2 

Ohio 2 1 1 2 1 12 4 N/A 

Oklahoma 1 1 1 1 1 24 2 2 

Oregon 24 4 2 2 4 24 2 2 

Pennsylvania 12 12 12 12 4 72 12 2 

South Carolina 2 2 2 2 2 5 2 2 

Texas 24 4 2 N/A 12 24 2 N/A 

Utah 1 1 2 2 2 4 1 N/A 

Vermont 12 4 2 2 4 24 2 2 

Virginia 3 3 3 3 3 12 12 12 

Washington 2 2 2 2 2 12 2 2 

West Virginia 24 4 2 2 12 24 2 1 

Source: Office of Inspector General analysis of Medicaid program survey responses, 2012. 

Replacement Schedules for Medicare Continuous Positive Airway Pressure Supplies (OEI-07-12-00250) 15 
 

 

 

 

 

 

APPENDIX B 

Decreases in Medicare Expenditures for Masks If the 

Replacement Schedule Were Changed 

If Medicare reduced the frequency of mask replacement from one per 

3 months to one per 6 months, expenditures would decrease by 

$14,212,244, or 14 percent. If Medicare reduced the frequency of mask 

replacement to one per 4 months, expenditures would decrease by 

$3,388,465, or 3 percent. The savings calculations assume that all 

beneficiaries who received masks at the current maximum frequency will 

decrease to the new maximum frequency and that there is no change for 

beneficiaries that received fewer masks than the current maximum 

frequency. 

Mask Type 

Impact If Replacement Schedule 

Changed to Two Masks Per Year 

Impact If Replacement Schedule 

Changed to Three Masks Per Year 

Number of 

Beneficiaries 

Affected 

Decrease in 

Allowed Dollars 

Number of 

Beneficiaries 

Affected 

Decrease in 

Allowed Dollars 

A7027 494 $121,816 140 $27,004 

A7030 29,512 $6,544,549 8,831 $1,564,440 

A7034 54,892 $7,545,879 16,561 $1,797,021

 Total 84,898 (18%) $14,212,244 (14%) 25,532 (5%) $3,388,465 (3%) 

Note: Dollar amounts are rounded to the nearest $1. 

Source: Medicare National Claims History File, 2012.
 

Replacement Schedules for Medicare Continuous Positive Airway Pressure Supplies (OEI-07-12-00250) 16 
APPENDIXC 


Agency Comments 


,.--........... 


Cen1e<ll IOJ Uedicare & Medicaid Services : DEPAIITMENT OF HEALTH & HUMAN SERVICES 

Admi"istrator '-;:j Washll)lllon, DC 20201 

APR 2 6 2013 DATE: 

TO: 	 Daniel R. Levinson 


Inspecto~General 


FROM: 	 Marilyn 'iiJVmner 


Acting Adlnlni strator 


SUBJECT: 	 Office of Inspector General (OIG) Draft Report: "Replacement Schedules for 

Medicare Continuous Positive Airway Pressure (CPAP) Supplies" (OEI-07-12­

00250) 

Thank you for the opportunity to review and comment on the above-subj~X:t draft report . OIG is 

trying to determine the extent to which the replacement schedule for CPAP supplies under 

Medicare's fee-for-service system differed from those ofother health insurers and the 

r~X:ommendations of clinicians and CPAP machine manufacturers. OIG found that supplies for 

which state Medicaid programs specified frequency schedules, 39 percent had replacement 

frequencies that were less frequent than those under Medicare and 51 percent had replacement 

frequencies equal to those under Medicare. Only 10 percent of supply replacement frequencies 

were more frequent than those under Medicare. Additionally, many state Medicaid programs 

have either recently changed their CP AP supply replacement schedules or have initiatives 

underway to do so. Two Federal Employees Health Benefits plans had no specific replacement 

schedule; the plans determined coverage on the basis of medical n~X:essity. Sleep medicine 

clinicians emphasized the importance of proper mask fit, but once mask fit is established, 

research indicated less frequent replacement of masks than Medicare allows. Finally, OlG found 

that manufacturers r~X:ommended specific replacement frequencies for only a few types of 

supplies, but those recommendations were often to replace those supplies on an as-needed basis 

and potentially less frequently than under Medicare's replacement schedule. 

OIG recommendation and CMS response to the recommendation is discussed below. 

OIG Recommendation 

The OIG recommends that CMS Review the CPAP Supply Replacement Schedule and Revise 

the National Coverage Determination for CP AP Therapy for OSA or Request That the DME 

MACs Revise Tileir LCDs as Appropriate . 

CMS Response 

The CMS does not concur with the OIG recommendation. In order to determine if CPAP supply 

refill frequency can be reduced, an analysis of Medicare beneficiary CPAP use similar to that 

performed in the Veterans Health Administration study is needed (i.e., comparing actual CPAP 

Replacement Schedules for Medicare Continuous Positive Airway Pressure Supplies (OEI-07-12-00250) 17 
 

Agency Comments (Continued) 

Replacement Schedules for Medicare Continuous Positive Airway Pressure Supplies (OEI-07-12-00250) 18 
 

ACKNOWLEDGMENTS 

This report was prepared under the direction of Brian T. Whitley, Acting 

Regional Inspector General for Evaluation and Inspections in the Kansas 

City regional office. 

Tricia Fields served as the team leader for this study. Other Office of 

Evaluation and Inspections staff from the Kansas City regional office who 

conducted the study include Jordan Clementi and Brian Pattison. Central 

office staff who provided support include Clarence Arnold, Scott Manley, 

and Christine Moritz. 

Replacement Schedules for Medicare Continuous Positive Airway Pressure Supplies (OEI-07-12-00250) 19 
Office of Inspector General

http://oig.hhs.gov 

The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as 

amended, is to protect the integrity of the Department of Health and Human Services 

(HHS) programs, as well as the health and welfare of beneficiaries served by those 

programs. This statutory mission is carried out through a nationwide network of audits, 

investigations, and inspections conducted by the following operating components: 

Office of Audit Services 

The Office of Audit Services (OAS) provides auditing services for HHS, either by conducting 

audits with its own audit resources or by overseeing audit work done by others. Audits 

examine the performance of HHS programs and/or its grantees and contractors in carrying 

out their respective responsibilities and are intended to provide independent assessments of 

HHS programs and operations. These assessments help reduce waste, abuse, and 

mismanagement and promote economy and efficiency throughout HHS. 

Office of Evaluation and Inspections 

The Office of Evaluation and Inspections (OEI) conducts national evaluations to provide 

HHS, Congress, and the public with timely, useful, and reliable information on significant 

issues. These evaluations focus on preventing fraud, waste, or abuse and promoting 

economy, efficiency, and effectiveness of departmental programs. To promote impact, OEI 

reports also present practical recommendations for improving program operations. 

Office of Investigations 

The Office of Investigations (OI) conducts criminal, civil, and administrative investigations 

of fraud and misconduct related to HHS programs, operations, and beneficiaries. With 

investigators working in all 50 States and the District of Columbia, OI utilizes its resources 

by actively coordinating with the Department of Justice and other Federal, State, and local 

law enforcement authorities. The investigative efforts of OI often lead to criminal 

convictions, administrative sanctions, and/or civil monetary penalties. 

Office of Counsel to the Inspector General 

The Office of Counsel to the Inspector General (OCIG) provides general legal services to 

OIG, rendering advice and opinions on HHS programs and operations and providing all 

legal support for OIG’s internal operations. OCIG represents OIG in all civil and 

administrative fraud and abuse cases involving HHS programs, including False Claims Act, 

program exclusion, and civil monetary penalty cases. In connection with these cases, OCIG 

also negotiates and monitors corporate integrity agreements. OCIG renders advisory 

opinions, issues compliance program guidance, publishes fraud alerts, and provides other 

guidance to the health care industry concerning the anti-kickback statute and other OIG 

enforcement authorities.