CMS has proposed significant changes in the Medicare physician self-referral (typically referred to as the “Stark Law”) regulations, including new compensation exceptions and several clarifications and refinements of existing Stark exceptions. Additionally, CMS is seeking comments and suggestions on possible new Stark exceptions. Hospitals, physician groups, laboratories, and other entities that provide “designated health services” should not miss this opportunity to provide input on this process.

In its Notice of Proposed Rule Making, CMS stated:

We are soliciting comments regarding the impact of the physician self-referral law on health care delivery and payment reform. We are interested in comments regarding perceived barriers to achieving clinical and financial integration posed by the physician self-referral law generally and, in particular, the “volume or value” and “other business generated” standards set out in our regulations. We are also interested in learning whether stakeholders see a need for guidance on the application of our regulations as they relate to physician compensation that is unrelated to participation in alternative payment models. On this subject, we specifically solicit comments regarding the “volume or value” and “other business generated” standards, but welcome comments regarding any of our rules for determining physician compensation.

CMS went on to post ten questions that are intended to solicit input on the effect of the Stark regulations and recent court decisions interpreting the Stark regulations on clinical and financial integration, value-based payment models, shared savings, gainsharing, and quality bonuses.

CMS plans to use information elicited from public comments for several purposes.

First, CMS will use the information to fulfill a mandate from Congress under the Medicare Access and CHIP Extension Act to determine whether new Stark exceptions to protect and promote gainsharing are appropriate.

Second, CMS will use the comments to determine whether the Stark regulations governing Medicare referrals are impeding the development of value-based reimbursement by employer-sponsored health plans, and whether new Stark exceptions are needed to promote new reimbursement models for payers other than Medicare.

Third, CMS will use the comments to determine whether new Stark exceptions are needed to promote clinical integration under circumstances where the fraud and abuse waivers authorized by the Affordable Care Act do not apply.

Finally, CMS will use the comments to evaluate whether regulations are not needed to protect Medicare from new kinds of fraud and abuse risks as alternative payment arrangements such as gainsharing, shared savings, downside risk sharing, and bundled payments become more common.

Comments are due on or before September 5, 2015. CMS reviews all comments received, and comments can influence the regulatory process.