July 15, 2015
2 min read
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Senators question CMS' tactic of enforcing policies as if they were law

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From international law firm Arnold & Porter LLP comes a timely column that provides views on current regulatory and legislative topics that weigh on the minds of today’s physicians and health care executives.

One of the great frustrations experienced by physicians and other providers who participate in the Medicare program is the confusion and inconsistency of Medicare policy. While formal regulations and other guidelines such as national coverage determinations are subject to notice and comment requirements, the vast majority of Medicare policies are buried in manuals and other guidance documents, many of which are virtually unknown to the provider community. Yet, often these policies are used to enforce overpayment determinations and even civil or criminal penalties.

Alan E. Reider

On May 7, however, Sen. Lamar Alexander, R-Tenn., chairman of the U.S. Senate Committee on Health Education Labor and Pensions, and Sen. James Lankford, R-Okla., chairman of the U.S. Senate Subcommittee on Regulatory Affairs and Federal Management, sent a letter to the Department of Health and Human Services Secretary Sylvia Mathews Burwell asking for documentation about the department’s use of guidance documents. The letter expressed concern “that federal agencies are increasingly using guidance that appears to create new requirements without the benefit of notice and comment but with the expectation that the public comply.” The letter also noted that such guidance appears to be an attempt by the agency to avoid regulatory requirements and take creative steps to bypass the Administrative Procedure Act. The letter then asked HHS to provide documentation of all guidance documents that have been the subject of a complaint relating to the failure of it to follow required procedures or improperly treating a guidance document as a binding requirement.

While this letter raises an important issue, the response by HHS will, in all likelihood, not address the hundreds, if not thousands, of cases where physicians and other providers have been subject to claims denials, overpayment recoupments, and more severe penalties for failing to follow interpretive guidelines that do not have the force of law, and that these physicians never knew existed. Given the concern raised by Sens. Alexander and Lankford, this may present an opportunity for the provider community to support this initiative by providing additional documentation where such rules have been improperly applied. In the highly complex regulatory environment in which providers must operate, the least that can be expected is that proper notice of these requirements be made available to the provider community.

Alan E. Reider, JD, MPH, a partner at Arnold & Porter LLP, can be reached at Alan.Reider@aporter.com.