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In this final post of our blog series on the substantial changes to the regulations implementing the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law), we cover change to (i) key Stark Law terminology, and (ii) the scope and application of the Stark Law exceptions. The Centers for Medicare & Medicaid Services (CMS) finalized new definitions for various key terms used in the Stark Law regulations as well as revisions to existing terms that are generally intended to provide more certainty and flexibility. This post discusses a few of the highlights, but the final regulations contain many others.
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In Advisory Opinion No. 20-05, posted September 23, 2020, OIG was unwilling to approve a pharmaceutical company s proposed cost-sharing subsidy program for beneficiaries seeking to use its expensive new drug for treatment of a rare cardiovascular disease. While OIG stated it was not in a position to reach a definitive conclusion regarding whether a violation of the federal Anti-Kickback Statute (AKS) existed, OIG was unwilling to issue a favorable advisory opinion. In particular, OIG was concerned that the arrangement would make beneficiaries less sensitive to the costs of their treatment, thereby risking an increase in the costs to the federal health care programs, and influencing clinical and beneficiary decision-making. Notably, OIG highlighted its use of publicly available information in reaching its conclusion under the AKS. With respect to the beneficiary inducement statute, OIG found the proposed arrangement did not
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HHS Finalizes Highly Anticipated Final Rule Amending Anti-Kickback Statute and Stark Law Regulations, Part V: Cybersecurity Technology and Electronic Health Records Friday, February 5, 2021
In this fifth installment of our blog series covering the changes, we dive into (i) the new AKS safe harbor and Stark Law exception for cybersecurity technology and related services, and (ii) the significant changes to the existing safe harbor and exception for electronic health records (EHR) technology.
Cybersecurity Technology and Related Services
In the face of mounting concerns about the financial losses and risks to patients caused by cyberattacks against hospitals and other health care providers, the agencies finalized a new safe harbor and a new exception for donations of cybersecurity technology and services. The health care industry – particularly hospitals – should welcome this new flexibility to donate cybersecurity technology and services to physic
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On 2 December 2020, the Office of Inspector General (OIG) in the U.S. Department of Health & Human Services (HHS) issued a long-awaited final rule (the Final Rule or Rule).
3The Final Rule adds multiple new safe harbors, revises several existing safe harbors under the federal Anti-Kickback Statute (AKS), and adds new protections under the Civil Monetary Penalties Law (CMP Law) which were first addressed in the 17 October 2019 proposed rule.
4 The Final Rule is a key part of HHS’s Regulatory Sprint to Coordinated Care, which aims to remove potential regulatory barriers to care coordination and value-based care created by applicable health care laws. HHS identified the broad reach of the AKS and the prohibition on beneficiary inducements in the CMP Law as potentially inhibiting beneficial arrangements that would advance the transition to value-based care and improve the coordination of patient care among providers and ac
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From December 23, 2020 through December 31, 2020, the OIG issued several advisory opinions. The advisory opinions analyzed (1) a program for a pharmaceutical manufacturer to provide financial assistance to certain patients, (2) a proposal from a qualified health center to offer gift cards to incentivize certain patients to attend preventative appointments, (3) a proposed web-based platform where health care facilities and clinicians could remit to patients and payors a portion of claims for which payment may be made by the Medicare program as a secondary payor, and (4) a management company’s provision of below fair market value Medicaid enrollment application assistance services and affiliated skilled nursing facilities’ payments for those services.