October 29, 2019

Health and Human Services Proposes Stark Law and Anti-Kickback Statute Reforms

On October 9, the Department of Health and Human Services (HHS) announced proposed changes to modernize and clarify the regulations that interpret the Physician Self-Referral Law (the “Stark Law”) and the Federal Anti-Kickback Statute. The proposed rules seek to provide greater certainty for healthcare providers participating in value-based arrangements and providing coordinated care for patients. The proposals would ease the compliance burden for healthcare providers across the industry, while maintaining strong safeguards to protect patients and programs from fraud and abuse. The proposed rules are part of HHS’s “Regulatory Sprint to Coordinated Care,” which seeks to promote value-based care by examining federal regulations that impede efforts among providers to better coordinate care for patients. The Stark Law’s new value-based exceptions, […]
April 30, 2019

New Legislation Seeks to Narrow Stark Law Exceptions for Certain Complex Non-Ancillary Services

Legislation was introduced in the U.S. House of Representatives which – if enacted – would narrow the “Stark” law’s exceptions and have a direct impact on the services provided by physicians who self-refer for the performance of certain designated health services. The 2019 bill is similar to previous proposals. If enacted, the bill would strengthen the Stark law by excluding specified complex “non-ancillary services” from the Stark law’s in-office ancillary services (IOAS) and physicians’ services exceptions, increasing penalties for violations, and adding compliance review provisions. With certain exceptions, the legislation would define non-ancillary services as: advanced diagnostic imaging studies; anatomic pathology services; radiation therapy services and supplies; physical therapy services; and any other service the Secretary determines “is not usually provided and […]