On November 20, 2020, the Department of Health & Human Services (HHS) released heavily anticipated final rules revising the regulatory exceptions to the Physician Self-Referral Law (also known as the Stark Law), the Anti-Kickback Statute (AKS) safe harbors, and the Beneficiary Inducements Civil Monetary Penalties (CMP) regulations.  The changes to the regulations go into effect on January 19, 2021 (except for one change to the Physician Self-Referral Law that becomes effective January 1, 2022). In a separate rule also released November 20th, HHS removed safe harbor protection for rebates involving prescription pharmaceuticals and created a new safe harbor for certain point-of-sale reductions in price on prescription pharmaceuticals and pharmacy benefit manager service fees.

The full text of each rule is available below.

The rules make a number of important changes to the regulations, and also provide new guidance on existing exceptions and safe harbors under those laws and regulations.

Revisions by CMS to the Physician Self-Referral Law regulations include, among others:

  • providing exceptions and integral definitions for value-based arrangements
  • a new exception for certain arrangements under which a physician receives limited remuneration for items or services actually provided by the physician
  • a new exception for donations of cybersecurity technology and related services
  • amending the existing exception for electronic health records (EHR) items

Revisions by the OIG to the Anti-Kickback Statute safe harbor regulations include, among others:

  • three safe harbors for value-based arrangements
  • safe harbor for certain patient engagement tools and supports in value-based arrangements
  • CMS-sponsored model arrangements safe harbor
  • cybersecurity technology and services safe harbor
  • electronic health records safe harbor
  • modifying the personal services and management contracts safe harbor
  • revising the warranty safe harbor
  • modifying the local transportation safe harbor including expanded mileage limits for rural areas and elimination of mileage limits to convey patients discharged from hospitals to their place of residence
  • codifying the statutory exception to “remuneration” relating to ACO Beneficiary Incentive Programs

Revisions by the OIG to the Beneficiary Inducements CMP regulations and related guidance include:

  • codifying the statutory exception for “telehealth technologies” furnished to certain in-home dialysis patients
  • clarifying that arrangements that fit into the new safe harbors for patient engagement and support, and local transportation, are protected under the Beneficiary Inducements CMP
Photo of Melissa (Lisa) Thompson Melissa (Lisa) Thompson

Lisa Thompson advises companies, senior management, and boards of directors, with a focus on the health care, life sciences, technology, and food and beverage industries. She is a member of the firm’s Health Law Group, Government Investigations, Food and Beverage Industry Group, and…

Lisa Thompson advises companies, senior management, and boards of directors, with a focus on the health care, life sciences, technology, and food and beverage industries. She is a member of the firm’s Health Law Group, Government Investigations, Food and Beverage Industry Group, and Data Privacy + Cybersecurity Team. Lisa is co-chair of the Health Law Section of the Boston Bar Association. She also serves as an international and domestic arbitrator on the Commercial, Life Sciences, and Health Care panels of the American Arbitration Association. She is a member of the AAA Life Sciences Advisory Council and the advisory committee for the Boston International Arbitration Council (BIAC).

Lisa has represented domestic and international clients in the health care, life sciences, technology, and food and beverage industries. Lisa handles a range of matters, including corporate law and contracting, government investigations and audits, clinical research law, and matters involving Institutional Review Boards (IRBs). She has extensive experience representing clients on matters involving privacy and security including HIPAA, reimbursement, Medicare and Medicaid, state and federal surveys and termination actions, managed care disputes, pharmacy and compounding laws, fraud and abuse, Stark Law, anti-kickback, and federal program exclusions. Read her full rc.com bio here.

Photo of Conor Duffy Conor Duffy

Conor Duffy is a member of Robinson+Cole’s Health Law Group and the firm’s Data Privacy + Security Team. Mr. Duffy advises hospitals, physician groups, accountable care organizations, community providers, post-acute care providers, and other health care entities on general corporate matters and health…

Conor Duffy is a member of Robinson+Cole’s Health Law Group and the firm’s Data Privacy + Security Team. Mr. Duffy advises hospitals, physician groups, accountable care organizations, community providers, post-acute care providers, and other health care entities on general corporate matters and health care issues. He provides legal counsel on a full range of transactional and regulatory health law issues, including contracting, licensure, mergers and acquisitions, the False Claims Act, the Stark Law, Medicare and Medicaid fraud and abuse laws and regulations, HIPAA compliance, state breach notification requirements, and other health care regulatory matters. Read his full rc.com bio here.