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.
- Final Physician Self-Referral Law Rule, Centers for Medicare & Medicaid Services (CMS): https://public-inspection.federalregister.gov/2020-26140.pdf
- Final AKS Rule and Beneficiary Inducements CMP Regulations, Office of Inspector General (OIG): https://public-inspection.federalregister.gov/2020-26072.pdf
- Final Rule on Rebate/Point-of-Sale Price Reductions Safe Harbor, OIG: https://public-inspection.federalregister.gov/2020-25841.pdf?utm_campaign=pi+subscription+mailing+list&utm_source=federalregister.gov&utm_medium=email
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