On July 15, 2015, the Centers for Medicare and Medicaid Services (“CMS”) published proposed revisions to the regulations implementing the physician self-referral law, or Stark Law.
The Stark Law is a key regulatory scheme in the healthcare industry that governs relationships between physicians and the providers to whom they refer certain designated health services. In order to receive Medicare reimbursement for these services, all financial relationships between providers and the referring physician must satisfy a statutory or regulatory exception to the Stark Law. These exceptions are complex and very technical, and providers who fail to fully comply with the Stark Law’s many requirements can be subjected to significant penalties and other sanctions.
Many of CMS’ proposed revisions appear designed to reduce the burden of some of these technical requirements. In addition, CMS is proposing several new exceptions. If enacted, these will be some of the most significant changes to the Stark Law in years.
Highlights of the proposed revisions include the following:
- Contractual requirements. Many of the Stark Law exceptions require the relationship between the parties to be “set out in writing” or be pursuant to a “written agreement.” CMS is proposing to revise all exceptions to contain the same language, using the phrase “arrangement.” CMS has further clarified that the “arrangement” does not have to be a formal, written contract, and the exceptions can potentially be satisfied by multiple documents evidencing the course of conduct between the parties.
- Recruitment of Nonphysician Practitioners (NPPs). CMS is proposing a new exception that would allow hospitals and other providers to provide recruitment support for nurse practitioners and other NPPs. Previously, this support had only been allowed for physicians.
- Timeshare Arrangements. CMS is proposing a new exception that would allow providers to enter into timeshare arrangements with physicians for the use of office space, equipment, personnel, supply and other services.
- Standardized language. CMS is proposing to standardize the use of certain phrases throughout the regulations. As described above, various references to “contracts” or “writings” will now be uniformly replaced with the term “arrangement.” In addition, all references to the volume or value of referrals between parties will use the phrase “takes into account.”
- Holdovers. Under the proposed regulations, parties may continue to provide services under leases and personal service agreements that have technically expired for an indefinite period without violating the Stark Law. Previously, providers could only do so for six months.
- Signature Requirements. Under the proposed regulations, contracts could be signed up to 90 days after services started and be considered compliant with the Stark Law. Previously, the period was only 30 days in most circumstances.
- Term Requirements. Many of the exceptions to the Stark Law require the parties to have an agreement for at least one year. CMS is clarifying that the contract or agreement between the parties does not have to have an explicit one-year term, so long as the relationship does in fact last one year. CMS is continuing the requirement that if an agreement is terminated prior to the one year term, the parties cannot enter into a similar agreement until that one-year period is up.
Providers who may be impacted by these proposed changes are encouraged to submit comments to CMS. Comments may be submitted electronically here and should be received by September 8, 2015.
Benesch is preparing an in-depth client alert analyzing the potential impact of these regulations. If you have questions regarding the scope and impact of these proposed regulations in the mean time, please contact any member of the Benesch Health Law team.