CMS issued last week its final rule modifying the Physician Self-Referral Law aka the Stark Law putting into place most of what it proposed to modify this summer. The majority of the new modifications become effective on January 1, 2016, though CMS indicates that many of the changes are just clarifications of existing application of the Stark Law.
Highlights of Some Proposed Revisions
The below list is not an all-inclusive list of the revisions to the Stark Law, but highlights some of the more substantial changes.
Temporary Noncompliance with Signature. Following the confusion between what was considered inadvertent and not inadvertent, CMS has modified this rule to allow the temporary noncompliance with the signature requirements for up to 90 days following the date of noncompliance regardless of the parties’ intention for not signing earlier.
Remuneration. The definition of remuneration has been revised to more clearly specify that certain items, devices, or supplies related to the collection, transportation, etc. of specimens are excluded from the definition of remuneration if used solely for one or more of such testing/specimen collection purposes.
Arrangement vs. Agreement. CMS clarifies in several of the exceptions (i.e personal services, leases, physician recruitment, etc.) that the requirement that the arrangement be set out in writing does not require a single formal contract but rather that several documents may establish sufficient documentation to satisfy the writing requirements. Examples of supplementary contemporaneous documents may include communications between the parties, check requests or invoices, time sheets, and call coverage schedules. Further examples are described within the final rule.
Holdover Provision. Prior to this final rule, the personal service arrangement, rental of office space and rental of equipment exceptions permitted a holdover arrangement for up to 6 months. CMS has modified these provisions to permit indefinite holdovers, provided that the arrangement continues on the same terms and conditions as the original arrangement.
Recruitment of Non-Physician Practitioners. CMS has added a new exception allowing a hospital (FQHC and RHC) to provide remuneration to a physician to compensate for non-physician practitioners if certain conditions are met (including cap of 50% of remuneration paid to non-physician practitioner and restriction on using the exception with the same referring physician only once every 3 years). Such non-physician practitioners include clinical psychologists and social workers, physician assistants, nurse practitioners, clinical nurse specialists and certified nurse midwives.
Timeshare Arrangements. CMS created a new exception for timeshare lease arrangements, which includes both space and equipment (supplies, items, services, etc.). The space/equipment must be predominately used for E/M services and remain on the same schedule. The equipment in the space must also be located in the same building as where the E/M services are furnished, not used to furnish DHS other than those incidental to E/M services furnished at the time of the patient’s visit and not include advanced imaging equipment, radiation therapy equipment or clinical & pathology lab equipment (other than CLIA waived tests).
The changes that relax some of the signature, holdover and writing requirements are consistent with CMS’ experience with SRDP submissions. Further the new exceptions recognize some of the changes in the delivery of patient care (such as non-physician providers and timeshare arrangements). If you have questions about any of these modifications or the Stark Law in general please contact Elana Zana.