THE NEW STARK LAW AND ANTI-KICKBACK STATUTE FINAL RULES PROVIDE NEW OPPORTUNITIES FOR VALUE BASED PROGRAMS AND VALUE BASED ARRANGEMENTS

ABSTRACT

The Stark Law and the Anti-Kickback Statute represent two of the most significant areas of liability for providers and participants in the health care industry. Often times, either or both of these laws can form the basis of a False Claims Act case. The key to avoiding liability is to ensure that the relevant exception(s) under the Stark Law and the relevant safe harbors under the Anti-Kickback Statute are met. With the evolution of value-based programs and reimbursement models based one value-based outcomes such as patient care coordination and quality measures, industry participants relayed to the Centre's for Medicare and Medicaid, as well as the U.S. Department of Health and Human Services that they were unable to effectively implement some value-based programs and types of legitimate arrangements for fear of civil and/or criminal exposure. The Government listened and in December 2020, two separate Final Rules were released, opening the door for new initiatives in the healthcare industry to achieve success with value-based programs and arrangements, so long as the new safe harbors and exceptions are met. This article details an overview of some of the critical aspects of the new Final Rules, which became effective on January 19, 2021 (with a couple of provisions that are effective at a later date).

Notes

1. 85 Fed. Reg. 77492 (Dec. 2, 2020).

2. 85 Fed. Reg. 77684 (Dec. 2, 2020).

3. The Centers for Medicare and Medicaid Services published the Stark Law Final Rule, while the U.S. Department of Health and Human Services – Office of the Inspector General published the AKS Final Rule.

4. CMS, Modernizing and Clarifying the Physician Self-Referral Regulations Final Rule (CMS-1720-F), https://www.cms.gov/newsroom/fact-sheets/modernizing-and-clarifying-physician-self-referral-regulations-final-rule-cms-1720-f; CMS, What are the value-based programs? https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/Value-Based-Programs.

5. American Hospital Association, Hospital Value-Based Purchasing, https://www.aha.org/hospital-value-based-purchasing/home (last visited Jan. 23, 2021).

6. Healthcare Finance, https://www.healthcarefinancenews.com/news/cms-will-pay-19-billion-hospitals-value-based-payments-inpatient-care (Oct. 31, 2019).

7. Id.

8. CMS, MACRA, https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-MIPS-and-APMs.

9. CMS, Hospital-Acquired Condition (HAC) Reduction Program, https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/HAC/Hospital-Acquired-Conditions.

10. CMS, Hospital Readmissions Reduction Program (HRRP), https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Readmissions-Reduction-Program.

11. See 42 CFR §411.351 (Stark Law); 42 CFR §1001.952(ee)(14)(viii) (AKS).

12. See https://www.physicianspractice.com/view/new-stark-law-and-anti-kickback-statute-final-rules-part-1-key-items (Dec. 3, 2020).

13. See https://usa.united-imaging.com/products/magnetic-resonance/umr-570-myostrain-edition/; see also https://www.myocardialsolutions.com.

14. 85 Fed. Reg. at 77657.

15. 42 CFR § 411.357(bb); 42 CFR § 1001.952(jj).

Additional information

Notes on contributors

Rachel V. Rose

Rachel V. Rose, JD, MBA, advises clients on compliance, transactions, and litigation in healthcare, cybersecurity, corporate and securities, False Claims Act and Dodd-Frank whistleblower areas of law. She also teaches bioethics at Baylor College of Medicine in Houston. Rachel can be reached through her website.