Appeal type: unknown
Decision: unknown

The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules state that Effective for claims with dates of service on and after March 13, 2008, the Centers for 
Medicare & Medicaid Services (CMS) determines that CPAP therapy when used in 
adult patients with OSA is considered reasonable and necessary under the following 
situations: 
1. The use of CPAP is covered under Medicare when used in adult patients with OSA. Coverage of CPAP is 
initially limited to a 12-week period to identify beneficiaries diagnosed with OSA as subsequently described 
who benefit from CPAP. CPAP is subsequently covered only for those beneficiaries diagnosed with OSA who 
benefit from CPAP during this 12-week period. 
2. The provider of CPAP must conduct education of the beneficiary prior to the use of the CPAP device to 
ensure that the beneficiary has been educated in the proper use of the device. A caregiver, for example a family 
member, may be compensatory, if consistently available in the beneficiary's home and willing and able to 
safely operate the CPAP device. 
3. A positive diagnosis of OSA for the coverage of CPAP must include a clinical evaluation and a positive: 
a. attended PSG performed in a sleep laboratory; or 
b. unattended HST with a Type II home sleep monitoring device; or 
c. unattended HST with a Type III home sleep monitoring device; or 
d. unattended HST with a Type IV home sleep monitoring device that measures at least 3 channels. 
4. The sleep test must have been previously ordered by the beneficiary's treating physician and furnished under 
appropriate physician supervision. 
5. An initial 12-week period of CPAP is covered in adult patients with OSA if either of the following criterion 
using the AHI or RDI are met: 
a. AHI or RDI greater than or equal to 15 events per hour, or 
b. AHI or RDI greater than or equal to 5 events and less than or equal to 14 events per hour with  
documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders or 
insomnia, or documented hypertension, ischemic heart disease, or history of stroke. 
6. The AHI or RDI is calculated on the average number of events of per hour. If the AHI or RDI is calculated 
based on less than 2 hours of continuous recorded sleep, the total number of recorded events to calculate the 
AHI or RDI during sleep testing must be at a minimum the number of events that would have been required in 
a 2-hour period. 
7. Apnea is defined as a cessation of airflow for at least 10 seconds. Hypopnea is defined as an abnormal 
respiratory event lasting at least 10 seconds with at least a 30% reduction in thoracoabdominal movement or 
airflow as compared to baseline, and with at least a 4% oxygen desaturation. 
8. Coverage with Evidence Development (CED): Medicare provides the following limited coverage for CPAP 
in adult beneficiaries who do not qualify for CPAP coverage based on criteria 1-7 above. A clinical study 
seeking Medicare payment for CPAP provided to a beneficiary who is an enrolled subject in that study must 
address one or more of the following questions 
a. In Medicare-aged subjects with clinically identified risk factors for OSA, how does the diagnostic 
accuracy of a clinical trial of CPAP compare with PSG and Type II, III & IV HST in identifying 
subjects with OSA who will respond to CPAP
b. In Medicare-aged subjects with clinically identified risk factors for OSA who have not undergone 
confirmatory testing with PSG or Type II, III & IV HST, does CPAP cause clinically meaningful harm 
 
 
c. The study must meet the following additional standards: 
d. The principal purpose of the research study is to test whether a particular 
intervention potentially improves the participants health outcomes. 
e. The research study is well-supported by available scientific and medical information or it is intended 
to clarify or establish the health outcomes of interventions already in common clinical use. 
f. The research study does not unjustifiably duplicate existing studies. 
g. The research study design is appropriate to answer the research question being asked in the study. 
h. The research study is sponsored by an organization or individual capable of executing the proposed 
study successfully. 
i. The research study is in compliance with all applicable Federal regulations concerning the protection 
of human subjects found at 45 CFR Part 46. If a study is Food and Drug Administration-regulated, it 
also must be in compliance with 21 CFR Parts 50 and 56. 
j. All aspects of the research study are conducted according to the appropriate standards of scientific 
integrity. 
k. The research study has a written protocol that clearly addresses, or incorporates by reference, the 
Medicare standards. 
l. The clinical research study is not designed to exclusively test toxicity or disease pathophysiology in 
healthy individuals. Trials of all medical technologies measuring therapeutic outcomes as one of the 
objectives meet this standard only if the disease or condition being studied is life-threatening as defined 
in 21 CFR 312.81(a) and the patient has no other viable treatment options. 
m. The clinical research study is registered on the ClinicalTrials.gov Web site by the principal 
sponsor/investigator prior to the enrollment of the first study subject. 
n. The research study protocol specifies the method and timing of public release of all pre-specified 
outcomes to be measured, including release of outcomes if outcomes are negative or study is terminated 
early. The results must be made public within 24 months of the end of data collection. If a report is 
planned for publication in a peer-reviewed journal, then that initial release may be an abstract that meets 
the requirements of the International Committee of Medical Journal Editors. However, a full report of 
the outcomes must be made public no later than 3 years after the end of data collection. 
o. The research study protocol must explicitly discuss subpopulations affected by the treatment under 
investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion 
and exclusion criteria affect enrollment of these populations, and a plan for the retention and reporting 
of said populations in the trial. If the inclusion and exclusion criteria are expected to have a negative  
effect on the recruitment or retention of underrepresented populations, the protocol must discuss why 
these criteria are necessary. 
p. The research study protocol explicitly discusses how the results are or are not expected to be 
generalizable to the Medicare population to infer whether Medicare patients may benefit from the 
intervention. Separate discussions in the protocol may be necessary for populations eligible for 
Medicare due to age, disability, or Medicaid eligibility. 
 
You can find these rules in the Medicare National Coverage Determination (NCD) for Continuous Positive 
Airway Pressure (CPAP) Therapy For Obstructive Sleep Apnea (OSA), Section 240.4 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.