CMS has posted the Decision Memo for Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea. An excerpt of the decision memo follows:
We received a request to reconsider the 2005 National Coverage Determination (NCD) for CPAP Therapy for OSA (CAG-00093R) to allow coverage of CPAP based upon a diagnosis of OSA by home sleep testing (HST). After considering public comments and additional information, we are making the following changes to the NCD for CPAP. The revised indications and limitations NCD are noted in Appendix B.
1 Coverage of CPAP is initially limited to a 12 week period for beneficiaries diagnosed with OSA as subsequently described. CPAP is subsequently covered for those beneficiaries diagnosed with OSA whose OSA improved as a result of CPAP during this 12 week period.
We remind the reader that Durable Medical Equipment, Prothetics, Orthotics, and Supplies (DMEPOS) suppliers are required to provide beneficiaries with necessary information and instructions on how to use Medicare-covered items safely and effectively. 42 CFR 424.57(c)(12). Failure to meet this standard may result in revocation of the DMEPOS supplier’s billing privileges. 42 CFR 424.57(d).
2 CPAP for adults is covered when diagnosed using a clinical evaluation and a positive:
a polysomnography (PSG) performed in a sleep laboratory; or
b unattended home sleep monitoring device of Type II; or
c unattended home sleep monitoring device of Type III; or
d unattended home sleep monitoring device of Type IV, measuring at least three channels
We remind the reader that, in general, pursuant to 42 CFR 410.32(a) diagnostic tests that are not ordered by the beneficiary’s treating physician are not considered reasonable and necessary. Pursuant to 42 CFR 410.32(b) diagnostic tests payable under the physician fee schedule that are furnished without the required level of supervision by a physician are not reasonable and necessary.
3 A positive test for OSA is established if either of the following criterion using the Apnea-Hypopnea Index (AHI) or Respiratory Distress Index (RDI) are met:
◦ AHI or RDI greater than or equal to 15 events per hour, or
◦ AHI or RDI greater than or equal to 5 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.
The AHI is equal to the average number of episodes of apnea and hypopnea per hour. The RDI is equal to the average number of respiratory disturbances per hour.
4 If the AHI or RDI is calculated based on less than two hours of continuous recorded sleep, the total number of recorded events to calculate the AHI or RDI during sleep testing is at least the number of events that would have been required in a two hour period.
5 We are deleting the distinct requirements that an individual have moderate to severe OSA and that surgery is a likely alternative.
6 CPAP based on clinical diagnosis alone or using a diagnostic procedure other than PSG or Type II, Type III, or a Type IV HST measuring at least three channels is covered only when provided in the context of a clinical study when that study meets the following standards:
A clinical study seeking Medicare payment for CPAP provided to the beneficiary pursuant to Coverage with Evidence Development (CED) 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?
The study must meet the following additional standards:
c The principal purpose of the research study is to test whether a particular intervention potentially improves the participants’ health outcomes.
d 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.
e The research study does not unjustifiably duplicate existing studies.
f The research study design is appropriate to answer the research question being asked in the study.
g The research study is sponsored by an organization or individual capable of executing the proposed study successfully.
h 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 regulated by the Food and Drug Administration (FDA), it also must be in compliance with 21 CFR Parts 50 and 56.
i All aspects of the research study are conducted according to the appropriate standards of scientific integrity.
j The research study has a written protocol that clearly addresses, or incorporates by reference, the Medicare standards.
k 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.
l The clinical research study is registered on the ClinicalTrials.gov website by the principal sponsor/investigator prior to the enrollment of the first study subject.
m 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 to be published 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 three (3) years after the end of data collection.
n 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 on 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.
o 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.
Consistent with section 1142 of the Social Security Act (The Act), the Agency for Healtcare Research and Quality (AHRQ) supports clinical research studies that the Centers for Medicare and Medicaid Services (CMS) determines meet the above-listed standards and address the above-listed research questions
Read the entire announcement here.