Department of Health and Human Services 
OFFICE OF 
 
INSPECTOR GENERAL 
 
 
 
 
 
 
R   S
EPLACEMENT  CHEDULES 
 
  M C
FOR  EDICARE  ONTINUOUS 
 
P   A P
OSITIVE  IRWAY  RESSURE 
 
S  
UPPLIES 
 
Daniel R. Levinson   
Inspector General  
 
June 2013 
OEI-07-12-00250   
   
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, 
HHSs 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 Medicares 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 Medicares 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 Medicares 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, HHSs  
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  
Medicares 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 UpdateOne 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 users 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 suppliessuch as 
masks, tubing, chinstraps, and filtersmust 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 beneficiarys OSA diagnosis is documented by a sleep 
 
5 CMS, Competitive Bidding UpdateOne 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. 11081114, April 1, 1999.  Accessed  at 

http://171.66.122.149/content/159/4/1108.abstract on March 12, 2012. 
 
Replacement Schedules for Medicare Continuous Positive Airway  Pressure Supplies (OEI-07-12-00250)   2 
   
   
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 
Description  Frequency  
Code  
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. 169175.  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 MACsCIGNA Government Services, National  
Government Services, and Noridian Administrative Servicesadherence 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 MACNational Heritage Insurance Companyadherence 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. 
Replacement Schedules for Medicare Continuous Positive Airway  Pressure Supplies (OEI-07-12-00250)   5 
   
   
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 Institutes 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. 
Replacement Schedules for Medicare Continuous Positive Airway  Pressure Supplies (OEI-07-12-00250)   6 
   
   
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  
A7027  A7030  A7034 
Number 
of Masks 
Number of   Allowed   Number of   Allowed   Number of   Allowed  
Beneficiaries   Dollars   Beneficiaries   Dollars   Beneficiaries   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 policys 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).  
Replacement Schedules for Medicare Continuous Positive Airway  Pressure Supplies (OEI-07-12-00250)   7 
   
   
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 Medicares 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 Medicares 
Replacement Schedules for CPAP Supplies 
Annual Frequency of Replacement 
HCPCS  Lowest   Highest  
Description 
Code   State  State 
Medicare 
Medicaid  Medicaid 
Frequency 
Program Program
Frequency  Frequency  
A4604   CPAP Tubing With Heating Element  1  24  4 
A7027   Combination Oral/Nasal CPAP Mask   1  12  4 
Replacement Oral Cushion for 
A7028   1  24  24 
Oral/Nasal Mask 
Replacement Nasal Pillows for 
A7029   1  24  24 
Oral/Nasal Mask, One Pair  
1 per 
A7030   Full Face Mask  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 
1 per 
A7034   Nasal Interface   24  4 
5 years 
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 
1 per 
A7046   Humidifier Water Chamber   12  2 
3 years 
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. Medicares  
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.   
Replacement Schedules for Medicare Continuous Positive Airway  Pressure Supplies (OEI-07-12-00250)   9 
   
   
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 Medicares replacement schedule 
and two plans had no specific schedules 
Of the four FEHB plans that we surveyed, two plans reported that they 
followed Medicares replacement schedule for CPAP supplies and the 
other two plans had not established specific schedules.  The two plans that 
followed Medicares 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.  
Replacement Schedules for Medicare Continuous Positive Airway  Pressure Supplies (OEI-07-12-00250)   10 
   
   
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 Medicares 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 patientsless than 1 mask per year (as compared to Medicares  
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 Medicares 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. 
Replacement Schedules for Medicare Continuous Positive Airway  Pressure Supplies (OEI-07-12-00250)   11 
   
   
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 Medicares 
replacement schedule.   
CPAP supplies are included in one product category of CMSs 
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 Medicares 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.  
Replacement Schedules for Medicare Continuous Positive Airway  Pressure Supplies (OEI-07-12-00250)   12 
   
   
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 CMSs comments. 
The full text of CMSs 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 
Annual  Frequency of Replacement 
State  
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) 
Annual  Frequency of Replacement 
State  
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. 
 
Impact If Replacement Schedule   Impact If Replacement Schedule  
Changed to  Two Masks Per Year   Changed to  Three Masks Per Year  
Mask Type  
Number of   Number of  
Decrease in   Decrease in  
Beneficiaries   Beneficiaries  
Allowed Dollars  Allowed Dollars 
Affected  Affected  
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 

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

~	
:  DEPAIITMENT OF HEALTH & HUMAN SERVICES  Cen1e<ll IOJ Uedicare & Medicaid Services
'-;:j  Admi"istrator
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 
   
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http://oig.hhs.gov  
 
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amended, is  to protect the integrity of the Department of  Health and Human Services  
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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  
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