December 16, 2020
- CA US
Mentorhealth
Phone:8003851607
Overview:
Mr. Wolfe will discuss best practices for structuring and evaluating new compensation models.
His presentation will also focus on regulatory requirements, key provisions, valuation considerations and potential pitfalls that should be avoided when designing a new model.
Why you should Attend: Today health care organizations are focused on developing compensation models that will position their physician enterprise for success. When health care organizations design a new compensation model, they must make sure the model complies with the Stark Law. This webinar will discuss how to perform this analysis. It will also discuss the potential impact that changes to the Stark Law may have if they are introduced by the government later this year.
Analysis: CMS Finalizes Updates to the Stark Law to Reduce Regulatory Burdens and Provide Flexibility to Providers Wednesday, December 16, 2020
On 2 December 2020, the Centers for Medicare & Medicaid Services (CMS) published a Notice of Final Rulemaking in the
Federal Register (Final Rule),
1 modifying the regulations implementing the federal physician self-referral law (the Stark Law).
2 In the Final Rule, CMS largely finalizes many of the proposals set forth in the Proposed Rulemaking issued on 17 October 2019 (Proposed Rule),
3 with certain modifications. CMS has indicated that many of the changes to the Stark Law are intended to provide additional flexibility and reduce administrative burden to health care providers in structuring arrangements to comply with the Stark Law, driven by the Department of Health and Human Services’ initiative to accelerate the transformation of the health care system to better pay for value and promote care coordination, titled
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The U.S. Department of Health and Human Services (“HHS”) recently issued two corresponding final rules amending the implementing regulations of the Physician Self-Referral Law (“Stark Law”), the Anti-Kickback Statute (“AKS”), and the Civil Monetary Penalties Law (“CMP”). Both rules are part of HHS’s examination of federal regulations that potentially impede health care providers’ efforts to transition to value-based care and improve coordination of patient care in Federal health care programs and the commercial sector. Most of the amended regulations are effective on January 19, 2021.
Created new exceptions for value-based arrangements
[co-author: Ashley Monzel]
A federal court recently allowed a plaintiff’s state law negligence claim, which utilized the Anti-Kickback Statute (“AKS”) and federal physician self-referral law (the “Stark Law”) as legal support to survive a motion for summary judgment. In Post v. AmerisourceBergen Corporation, No. 1:19-CV-73 (N.D.W. Va. Nov. 2, 2020), Plaintiff, Frances G. Post, filed suit against Defendants, AmerisourceBergen Corporation, US Bioservices Corporation, I.g.G. of America, Inc., and HIS Acquisition XXX, Inc., alleging negligence claims arising from Plaintiff’s purchase of immunoglobulin (“IVIG”). Facing a motion to dismiss, the court allowed the Plaintiff to utilize these federal fraud and abuse laws to support a state law cause of action.
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The US Department of Health and Human Services’ Office of Inspector General updated the warranty safe harbor to account for bundled product and service warranties to reflect realities of healthcare product sales, but rejects industry calls for broader protections.
The Anti-Kickback Statute (AKS) is a criminal statute that can also result in significant civil penalties and exclusion by HHS-Office of Inspector General (OIG). Consequently, the healthcare industry, including healthcare product manufacturers and buyers of their products, are greatly influenced by OIG’s interpretation of the AKS as well as the legal protections the agency affords to financial and other arrangements under the AKS safe harbors. Although compliance with safe harbors is voluntary, with the high stakes for noncompliance, many manufacturers and other vendors to healthcare buyers have long tried to structure their sales transactions to meet or com