safe harbor

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On October 17, 2019, the Department of Health and Human Services (HHS) published proposed rules to update the regulatory Anti-Kickback Statute (AKS) safe-harbors and exceptions to the Physician Self-Referral (PSR) Law, known commonly as the Stark Law (AKS proposed rule available here; PSR proposed rule available here). In an earlier blog post, we described each of the proposed rules. Among the proposed changes are a new safe harbor/exception that would generally permit entities to donate certain cybersecurity technology and related services to physicians, subject to compliance with the conditions described below. In the preamble to each proposed rule, the HHS Office of Inspector General (OIG) (which published the AKS proposed rule) and the Centers for Medicare and Medicaid Services (CMS) (which published the PSR proposed rule) noted that cyber-attacks in the health care industry are on the rise and cybersecurity technology can be cost-prohibitive for some providers. Both OIG and CMS stated their hope that the proposed rules will improve overall cybersecurity in the health care industry and reduce instances of data breaches resulting from cyber-attacks.
Continue Reading HHS Proposes Changes to Permit Donation of Cybersecurity Technology

On October 18, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services published a favorable Advisory Opinion regarding a Medicaid managed care organization’s (Requestor) proposal to pay incentives to its network providers who meet benchmarks for increasing the amount of early and periodic screening, diagnostic, and treatment (EPSDT) services provided to Medicaid beneficiaries (Proposed Arrangement).
Continue Reading OIG Issues Favorable Advisory Opinion Regarding Health Plan’s Incentive Payment Program

The U.S. District Court for the District of Connecticut granted a motion for summary judgment in favor of Becton, Dickinson & Co. (BDC), a medical products provider, on the grounds that its contracts with MedPricer.com, Inc. (MedPricer), a company operating an online auction platform, violated the federal Anti-Kickback Statute (AKS), and were therefore unenforceable under Connecticut state law. MedPricer.com, Inc. v. Becton, Dickinson & Co., 2017 U.S. Dist. LEXIS 30854 (Memorandum opinion).

As described in the opinion, MedPricer enters into service agreements with hospitals and other health care providers to host online “auctions” for the sale of medical equipment. The health care provider determines which vendors to invite to the online auction and MedPricer sends invitations to the vendors. In order to participate in the MedPricer auction, a vendor must, among other things, accept the terms of a click-through user agreement. Vendors that accept the terms of the agreement may submit bids to the health care provider in response to requests for quotes. The agreements at issue before the Court required BDC to pay MedPricer a fee of 1.5% of the value of any purchase from the vendor, whether or not the sale occurs during the auction events or afterward.Continue Reading Federal Court Holds Online Medical Products Auction Contract Violates the AKS

On December 7, 2016, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited final rule establishing new Anti-Kickback Statute (AKS) safe harbor protections and codifying regulatory exceptions to the Civil Monetary Penalties Law (CMP).

Local Transportation Safe Harbor

This safe harbor protects local transportation made available by an “Eligible Entity” as long as the following conditions are met.  An “Eligible Entity” is any individual or entity, except for individuals or entities (or family members or others acting on their behalf) that primarily supply health care items (for example, durable medical equipment suppliers or pharmaceutical manufacturers).
Continue Reading New Anti-Kickback Safe Harbors and Exceptions to CMP Law