September 1, 2015
The Centers for Medicare & Medicaid Services (CMS) recently proposed regulatory changes to the Stark Law that may ease certain compliance challenges. The Physician Self-Referral Law, located at 42 U.S.C. § 1395nn, and its regulations at 42 C.F.R. § 411.350 et seq. (commonly known as the Stark Law) prohibit a physician from referring a patient for Medicare- and Medicaid-designated health services (DHS) to an entity where the physician or his or her family has a financial relationship, absent an exception. As CMS reviewed recent cases and self-disclosures involving Stark Law violations, CMS decided changes were needed to clarify and ease provider compliance. A summary of these changes, which are included in the 2016 Physician Fee Schedule Proposed Rule, follows.
On the whole, these revisions suggest CMS wants to ease the burden of Stark Law compliance on providers. CMS noted throughout its proposed rule that it has received self-disclosures and other reports of violations that it does not believe pose fraud or abuse risks to Medicare or that do not represent actual violations of the Stark Law. Many of these proposals will be welcome by the provider community and may reduce the number of Stark Law procedural violations. That said, providers will continue to be challenged by these laws. They now face new guidance to digest, and may want to request additional changes from CMS either in response to these proposals or in advisory opinions. Such requests may find a positive response as CMS appears willing in this proposed rule to clarify the Stark Law to focus on fraud and abuse concerns while reducing provider burdens.
The public may comment on these proposals until September 8, 2015. The authors of this Legal Alert will be happy to speak with any provider seeking to submit such a comment letter.