QUESTION: Are you aware of anything new on the Proposed Stark Rules and Anti-Kickback Safe Harbors? If they are adopted now, is there anything that could affect those rules from going into effect?
ANSWER: The answer to both of your questions is yes.
You are referring to the proposed regulations to the Stark Law and the proposed safe harbor regulations to the Medicare Anti-Kickback Statute that were proposed on October 17, 2019. The notice and comment period for these rules ended on December 31, 2019 (click the links below to read our comments on these rules).
Comments on Proposed Safe Harbor Regulations (File Code OIG-0936-AA10P)
Comments on Proposed Regulations to the Physician Self-Referral Law (File Code CMS-1720-P)
While the rules have not been published in final form, according to a July 21, 2020 posting by the Office of Management and Budget, those regulations are under review by OMB and it is our understanding that these rules remain a high priority for CMS.
The proposed rules provide practical, realistic guidance for compliance with both the Stark law and the Medicare Anti-Kickback Statute. It is our hope that both sets of regulations are published in final form in much the same form as proposed.
But here is where life gets complicated. Due to a provision in a little known law called the Congressional Review Act (“CRA”) and the upcoming Presidential, House and Senate elections, publication of those rules in final form at this late date in the Trump administration may not be enough for them to remain in effect.
The CRA was enacted in 1996. The provision in the CRA to keep an eye on is the section of the CRA that applies to regulations that are published within 60 legislative days of the end of a presidential term (which has long passed).
The CRA requires regulatory agencies to submit their rules, regulations, and guidance documents to Congress before they can officially take effect. Congress has 60 legislative days to review a rule. If Congress does nothing, then the rule takes effect. However, if a simple majority in the House and the Senate (filibuster rules do not apply) do not like the rule/regulation/guidance, they can issue a “resolution of disapproval.” Once the “resolution of disapproval has passed, unless it is vetoed by the President, the rule/regulation/guidance document is dead.
It is important to note that as a practical matter, the CRA will only be relevant if there is a change in the President, the Democrats hold the House and the Democrats flip the senate. If that does not occur, then it will be virtually impossible to get the votes necessary for the CRA to apply.
Prior to the Trump Administration, the CRA was only used once. However, after President Trump was elected and the Republicans held a majority in the House and Senate, the CRA was used 14 times to invalidate Obama/Biden Administration enacted rules. It will be interesting to see if the Democrats will do the same if they are given the chance and whether the Stark rules and/or the Safe Harbor regulations will be a victim of the CRA.