Hall Render attorney Joseph N. Wolfe spoke to Becker's ASC Review about what CMS' proposed rule could mean for Stark Law, and how potential changes could help or hurt ASCs.
Note: Responses were lightly edited for style and clarity.
Question: What kinds of changes are you anticipating in the final Stark Law rule?
Joseph N. Wolfe: In the proposed rule, it's likely that CMS will focus on updating some of the definitions and exceptions that need additional clarification. The changes also could include a new definition for commercial reasonableness and a more objective standard for what conduct and models actually take into account — the volume or value of referrals.
Many industry stakeholders would like to see changes to the "fair market value" definition, even going as far as creating an acceptable process for documenting fair market value. We could see CMS go as far as developing a rebuttable presumption of fair market value in line with the current IRS process. The AHA proposed this approach in its recent comments to CMS. CMS has previewed that it could introduce a new exception (or multiple exceptions) that are aimed at protecting arrangements involving clinical integration, care coordination and participation in advanced alternative payment models.
It will be interesting to see if the new exceptions will have any of the features of the value-based exception CMS proposed several years ago that was intended to cover incentive payments and shared savings. That exception was never finalized.
Q: Do you predict that the changes will help or hurt ASCs?
JW: ASCs could be impacted indirectly. If CMS loosens the Stark Law restrictions, as they apply to hospitals and medical groups, it could hurt ASCs because those entities may be able to develop more creative and innovative arrangements that better compete in the marketplace. In contrast, Stark changes could help ASCs by giving them more opportunities to contract and partner with hospitals, health systems and medical groups.
Q: Why else should ASCs in particular be paying attention to the possible changes?
JW: CMS's enhancements to the Stark Law could be a preview of future changes that could be coming directly to ASCs if the [Office of Inspector General] also moves forward with reforming the Anti-Kickback Statute.
Want to share your thoughts on this topic? Email Angie Stewart: astewart@beckershealthcare.com.