CMS seeks input on the regulatory burden of the Stark law and ideas for possible changes

June 24, 2018

Health Care Alert

Author(s): Rebecca Simone, Valerie Breslin Montague

This alert was co-authored by Christopher Tonellato.

Last week, the Centers for Medicare and Medicaid Services issued a RFI relating to aspects of the federal physician self-referral law, commonly known as the Stark Law. Public comments are due by August 24, 2018. This alert discusses what health care providers need to know.

On June 20, 2018, the Centers for Medicare and Medicaid (CMS) issued a Request for Information (RFI) relating to many aspects of the federal physician self-referral law, commonly known as the Stark Law. This is part of an ongoing initiative by the Department of Health and Human Services to assess issues in the current regulations that may be acting as barriers to coordinated care.

The list of topics CMS requested information about is quite extensive. The RFI asks for details of any alternative or novel payment models or financial arrangements involving entities providing certain designated health services regulated by the Stark Law and referring physicians. In connection to these models, the request seeks information on how the current Stark Law exceptions help or hinder coordinated care, as well as whether any new exceptions would be useful to protect the new or alternative payment models.

The RFI also seeks the public’s thoughts on more specific items, such as the utility of the risk-sharing exception, suggestions of definitions for several important terms, and costs associated with compliance. It even poses the question of whether a referring physician providing transparency of their financial relationships, price, or other related data to a beneficiary would “reduce or eliminate the harms to the Medicare program and its beneficiaries that the physician self-referral law is intended to address.”

CMS encourages the public or any interested parties to provide responses to the topics put forward. “We are looking for information and bold ideas on how to change the existing regulations to reduce provider burden and put patients in the driver’s seat,” said CMS Administrator Seema Verma. Public comments are due by August 24, 2018.

The full RFI can be found in the Federal Register here.

This RFI comes only a few years after CMS made many significant changes to the Stark Law, all of which went into effect on January 1, 2016. The 2016 revisions included two new exceptions, revisions to several existing exceptions, and clarifications of some regulatory terminology. The new exceptions related to Federally Qualified Health Centers, Rural Health centers, and some specific timeshare agreements. CMS also simplified or clarified some of the signature requirements, as well as allowed expired leases and personal services arrangements to continue indefinitely on the same terms as long as they were otherwise compliant.

A more detailed analysis of the 2016 changes may be found in our previous alert here.

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