Here are 10 changes made or proposed at the federal or state level that Becker's has reported on since 2021:
1. A House committee unanimously advanced legislation that would make permanent an in-office ancillary services exception to Stark law for drugs provided under Medicare. The legislation would make permanent a CMS waiver instituted during the COVID-19 public health emergency that allowed Medicare patients to receive medications by mail or allow caregivers and family members to get medications for them.
2. In January, it was ruled that ASCs, physician groups and hospitals can provide non-monetary compensation to physicians up to an amount of $507 in 2024. Non-monetary payments that do not exceed $507 can be provided as long as the pay does not take into account the volume or value of referrals generated by the physician and is not solicited by the physician.
3. The Consolidated Appropriations Act of 2023 updated exceptions to Stark law to allow healthcare providers to improve mental health services for physicians. The law issues a new exception for physician wellness programs offered by healthcare entities, including ASCs, hospitals and physician practices. To satisfy the exception, the program must also include a written policy, which must include a description of the content and duration of the program, a description of the evidence-based support, and the estimated costs, among other stipulations.
4. In July 2023, Florida passed a law amending supervision stipulations. The legislation removes a direct supervision requirement in which the law's referral exception only applied if services were being provided under the supervision of the referring provider.
5. In June 2023, CMS added a Stark law waiver for physician owners of independent freestanding emergency departments that served Medicare patients during the COVID-19 pandemic. The waiver applies retroactively and is the first time CMS has modified its blanket Stark law waivers since 2020, according to the report. Independent, freestanding emergency departments will now receive similar protections to ASCs, which were also able to convert to hospitals during the pandemic.
6. In January 2023, CMS updated its voluntary self-referral disclosure laws, including an updated version of the self-referral disclosure protocol form, an updated physician information form and a new group practice information form. The new self-referral disclosure protocol form includes an update to signed certification — it no longer needs to be submitted as a hard copy and can now be submitted electronically.
7. In a 2022 proposed payment rule update released July 2021, CMS refined Stark law regulations on indirect compensation arrangements for physician referrals to services performed by immediate family members. CMS clarified the indirect compensation arrangement definition of compensation units as payment for anything other than services personally performed by the immediate family member.
The proposed rule update includes payment for space, equipment and services performed by a family member or company the family member has ownership in.
8. In 2021, CMS clarified in an advisory opinion that physicians are prohibited from referring patients for select designated health services to entities they have financial ownership in, unless the relationship falls under an exception. CMS stated that a physician group practice could be defined as a "single legal entity" if the group met the following standards: All clinical employees are employed by or contracted with the physician group and subsidiary revenue and expenses are treated as group practice revenue and expenses
9. In 2021, CMS and HHS made adjustments to the Stark Law which affect calculations of fair market value for physician pay. CMS unveiled three definitions for fair market value in the new rule, focused on general services, equipment rental and office space. The final rule defined general market value of compensation as "compensation that would be paid at the time the parties enter into the service agreement as a result of bona fide bargaining between well-informed parties that are not otherwise in a position to generate business for each other."
The final rule also addressed physician pay under value-based payments, saying organizations should base payments for outcomes on objective and measurable data.
10. Also in 2021, CMS-issued final regulations also included a section on productivity bonuses and profit sharing for medical groups. The agency prohibits physicians from referring patients to their practices for designated health services, but does offer exceptions if the practice distributes profits appropriately.
Physician practices can segment groups of five or more physicians by specialty, location, full- or part-time status and tenure, among other criteria, for profit sharing if the groups are not related to the physicians' referral volume or value. Physician practices can treat physician distribution groups differently for profit sharing and can use separate distribution methods for each group.