Life Science Compliance Update

July 26, 2017

LSCU SPECIAL FEATURE: Into the Nexus - Anti-Kickback Statute ("AKS") versus Value-Driven Health Care

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Part 2: The Tension Increases - Online Auctions Violate the AKS

We have noted in previous articles that there is an increasing tension between efforts to reduce healthcare costs and assuring those efforts are not improper inducements under the Anti-Kickback Statute’s (“AKS”). In a recent opinion by the Federal District Court in Connecticut, that tension ratcheted up several notches with the Court’s novel application of the AKS to certain e-commerce arrangements.


The decision in Medpricer.com, Inc. v. Becton, Dickinson & Co was originally decided in March 2017 and reaffirmed in April. Judge Michael Shea’s decision resolved a contract dispute between MedPricer, a company that provides an online portal for the auctioning of medical supplies and equipment, and Becton, Dickinson & Company (“BD”), a medical products provider.

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July 24, 2017

LSCU SPECIAL FEATURE: Into the Nexus - Anti-Kickback Statute ("AKS") versus Value-Driven Health Care

TNG

Part 1: An Uncertain Future in a Dynamic Landscape

Fans of Star Trek will remember the scene from the 1994 movie “Generations” in which Captains James T. Kirk and Jean-Luc Picard meet each other in The Nexus: the old versus the new. As the need to reform the healthcare system becomes ever more urgent, a new Nexus has developed between the old legal and regulatory framework (i.e., the Anti-Kickback Statute) and new ways of incentivizing the system to reward improved patient outcomes (i.e., Value Driven Health Care).

Health care is changing, including the way in which payments, compensation, and value policies and procedures are being implemented. As one recent article notes, these “changes are moving healthcare from a fee-for-service reimbursement model to a fee-for-value payment and care delivery model [including the] passage of the Patient Protection and Affordable Care Act of 2010 (ACA)."

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July 21, 2017

The California Hurdle - SB 790 and Pharma

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Seven states and the District of Columbia currently have regulations that limit or ban industry gifts to physicians, and it seems as though others are following suit. The California state Senate passed SB 790 in May 2017, a bill restricting pharmaceutical companies from giving gifts and incentives to medical professionals. This article reviews the changes SB 790 calls for, and what compliance professionals should keep an eye on.

The California Senate passed a bill (“SB 790”) in May 2017 that, if enacted, will change how pharmaceutical companies interact with health care professionals (“HCPs”). While standards and requirements for transfers of value are not new to pharmaceutical companies, SB 790 introduces new concepts for California, including:

• new standards for ‘allowable expenditures,’ which includes limitations on sponsorship of conferences or seminars that are educational, policy making, medical, or scientific;

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