On November 8, 2021, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) released a revised Provider Self-Disclosure Protocol, renamed Health Care Fraud Self-Disclosure Protocol (“SDP”). Prior to this update, the SDP had not been updated since 2013. While many of the revisions were procedural only, some of the revisions were...
On April 26, 2021, the Department of Health and Human Services Office of Inspector General (“OIG”) issued favorable Advisory Opinion No. 21-02 regarding a proposed investment in an ambulatory surgery center (“ASC”) by a health system, orthopedic surgeon and neurosurgeon employees of the health system, and a management company. This latest Advisory Opinion is notable...
On June 1, 2020, the Department of Justice (“DOJ”) issued an updated version of its “Evaluation of Corporate Compliance Programs” (the “DOJ Guidance”), available here. The DOJ Guidance is an update to guidance first issued by the DOJ in February 2017 (which we described in our prior blog post), and was last updated by the...
In the calendar year 2020 Medicare physician fee schedule final rule (“PFS”), which was published in the Federal Register on November 15, 2019 (available here), CMS finalized changes to the advisory opinion process under the federal physician self-referral law (“Stark Law” or “Stark”). CMS also published its annual update to CPT/HCPCS codes used to identify...
Today, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) each released their long-anticipated proposed rules to revise the federal self-referral law (or “Stark Law”) regulations, the safe harbors under the federal anti-kickback statute (AKS), and the civil monetary penalty law (CMP)...
The Office of Inspector General of the Department of Health and Human Services (“OIG”) released a proposed rule to eliminate safe harbor protection under the anti-kickback statute for drug price reductions that pharmaceutical manufacturers pay to Medicare and Medicaid plan sponsors and their pharmacy benefit managers (“PBMs”). The OIG proposed replacing the current safe harbor...
The Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) has identified the anti-kickback statute (AKS) and beneficiary inducements civil monetary penalty (CMP) as potential barriers to arrangements that could promote better patient care coordination and value-based arrangements. On August 27, 2018, the OIG published a Request for Information (RFI) seeking input...
On January 5, 2018, the Office of the Inspector General of the United States Department of Health and Human Services (“OIG”) released a favorable Advisory Opinion 17-09 that addresses Section 1128A(b)(1) of the Social Security Act (the “Gainsharing CMP”) and Section 1128B(b) of the Social Security Act (the “Anti-Kickback Statute”) with respect to a cost-reduction...
Alissa SmithAlissa represents health systems, hospitals, pharmacies, long-term care providers, home he...
Hannah McCallumHannah brings specialized knowledge and real-life experience to help her clients make infor...
Andrew BrantinghamAndrew's experience spans a wide range of industries, and has particular depth in...
Rebecca BrommelBecki assists clients in the areas of litigation and administrative law wit...
Katie CownieKatie has worked on business and corporate issues for more than 20 years. Many of...
Lillie CoxLillie assists a wide array of healthcare industry clients with corporate transact...
Ross C. D'EmanueleRoss works in the health care provider, payor, and drug and medical device segment...
Nathan EbnetNate represents clients in all stages of complex civil disputes, from pre-...
Elise FesterElise counsels a wide variety of clients in the Health Care industry on regulatory...
Adam FreedAdam provides strategic advice to health care providers through all stage...
Randall HansonRandall is an associate in Dorsey’s health transactions and regulations practice group.
Alan IversonAlan is a litigator in Dorsey’s trial group with a focus on clients in...
Michael JenkinsMike serves clients in highly regulated industries, including health care and gam...
Jamie McCartyJamie counsels clients in the healthcare industry in connection with complex busi...
Neal N. PetersonNeal regularly advises clients regarding compliance with laws specific to the he...
Mara SandersMara regularly advises clients on matters of state and federal regulatory complia...
Vanessa J. SzalapskiVanessa's practice focuses on litigation in the healthcare industry, including gen...
Claire H. ToppClaire works in three diverse sectors – health care, tax exempt organizations,...