On July 12, 2018, CMS included within the CY 2019 Physician Fee Schedule (the “Proposed Rule”) two revisions to Stark Law regulations aimed at further clarifying any actual or perceived differences between current regulations and the recently enacted Bipartisan Budget Act of 2018 (“2018 BBA”). As we previously reported, Section 50404 of the 2018 BBA codified certain Stark Law guidance promulgated through CMS rulemaking and commentary in 2015, as covered here.
First, CMS has proposed a new special rule on compensation arrangements regarding the satisfaction of the writing requirement by a “collection of documents.” This new rule would codify existing policy that allows the writing requirement for excepted compensation arrangements to be satisfied by a “collection of documents,” including contemporaneous documents evidencing the course of conduct between the parties. While the “collection of documents” concept began as a clarification articulated through preamble commentary in 2015, it has since been judicially validated, statutorily codified through the 2018 BBA, and would now be reflected in updated regulatory text.
Second, CMS has proposed modifications to the current regulation relating to temporary noncompliance with the signature requirement. Currently, in connection with certain types of compensation arrangements, parties are allowed to remedy noncompliant signatures within 90 calendar days, provided that all other criteria of the targeted exception are met. However, with respect to a particular DHS entity, the regulatory text presently still only allows a noncompliant signature to be remedied once every 3 years, per physician.
In the Proposed Rule, CMS has proposed removing the 3 year limitation and broadening the rule to apply to any applicable exception, in each case to align with the 2018 BBA. This change would be retroactively effective to February 9, 2018, matching the enactment of the 2018 BBA.
Comments on the Proposed Rule must be submitted by 5:00 p.m. on September 10, 2018.