In a move that has the potential to alter CPAP reimbursement, CMS is “proposing to prohibit payment to the supplier of the CPAP device when such supplier, or its affiliate, is directly or indirectly the provider of the sleep test that is used to diagnose a Medicare beneficiary with OSA,” according to information published in the Federal Register.

Previous payment policy has already stated that the test cannot be performed by the same entity that is the supplier. However, says Clay Stribling, JD, an attorney with the Health Care Group of Brown & Fortunato PC, an Amarillo, Tex-based law firm, “that would open the door in a lot of cases for companies that have the same ownership—even though they are different legal entities—to one of them doing the testing and the other doing the CPAP provision. This [proposal] presumptively would end some of those situations where the same owners owned the sleep testing side and the CPAP side—now they are going to be considered affiliated companies and those relationships would presumptively go away.”

The proposed policy is open for comments and may need to offer further clarification on portions of the proposal, particularly relating to the definition of “affiliate.” “They will either have to clarify that through additional rule-making or give us some additional guidance when they come out with the final rules as to what affiliate means for this purpose,” says Stribling. “It could be as broad as any company with any common ownership with the DME supplier or it could be a threshold of how common the ownership has to be.”

In forming final policy, the proposal will have to go through a comment period, which ends August 29, before issuance of a final regulation takes place. With the complexity of the issue, final regulations aren’t expected until at least the end of September, according to Stribling’s estimates.

Information about comments on the proposal can be submitted as follows:

Electronic comments may be submitted via [removed]www.regulations.gov/search/index.jsp[/removed]. Follow the instructions for "Comment or Submission" and enter the file code CMS-1403-P.

Comments may be sent by mail to the following address:
Department of Health and Human Services
Attn: CMS-1403-P
PO Box 8013
Baltimore, MD 21244-8013

Comments may be sent by overnight mail to the following address:
Department of Health and Human Services
Attn: CMS-1403-P
Mail Stop C4-26-05
7500 Security Blvd
Baltimore, MD 21244-1850