The U.S. Department of Health and Human Services (“HHS”), through its Office for Civil Rights (“OCR”), recently issued a “Dear Colleague” letter, Ensuring Nondiscrimination Through the Use of Artificial Intelligence (“AI”) and Other Emerging Technologies, which emphasizes the importance
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DOJ exceeds $2.9 billion in FCA recoveries in 2024 and reports a record number of qui tams
On January 15, the Department of Justice (DOJ) reported that False Claims Act (FCA) recoveries for civil cases in fiscal year 2024 totaled approximately $2.9 billion, representing about a $200 million increase from 2023. And these numbers do not account
OIG Issues Favorable Opinion on Free Access to Pharmaceutical Products
In its first advisory opinion of the year, the Department of Health and Human Services Office of Inspector General (OIG) issued a favorable advisory opinion on January 15, 2025 that addressed an arrangement by a pharmaceutical manufacturer to offer certain
Perceived industry compliance failures prompt stringent proposed HIPAA Security Rule
In an era where cyberattacks on the health care industry have become alarmingly frequent and catastrophic, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has taken a bold step forward. The recently issued Notice
OIG Issues Favorable Opinion on Dental Equipment Supplier’s Loyalty Program
The Department of Health and Human Services Office of Inspector General (OIG) recently issued an advisory opinion related to a proposed arrangement offering discounts to dental providers. This favorable advisory opinion, issued on December 9, 2024, offers fresh guidance and
OIG Issues Voluntary Compliance Guidance for Nursing Facilities
A year after issuing its General Compliance Program Guidance, the Department of Health and Human Services Office of Inspector General (“OIG”) has published the first industry-specific compliance guidance with “Industry Segment-Specific Compliance Guidance for Skilled Nursing Facilities and Nursing
OCR Sets Precedent with Settlement Over Impermissible Disclosure of Reproductive Health Information
The U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) will start to enforce compliance later this month with new special protections for individuals’ reproductive health information as required by a recently finalized HIPAA Privacy Rule, as
Medicare overpayment rule standard changes finalized in 2025 CMS Physician Fee Schedule
In the final 2025 Medicare Physician Fee Schedule, which is set to be published in the Federal Register on December 9, the Centers for Medicare and Medicaid Services (CMS) included substantive changes to the regulations governing when a provider must
Proposed Rule Could Enhance Contraceptive Coverage If It Survives New Administration
On October 21, 2024, the U.S. Department of Health and Human Services, Labor Department, and the Treasury Department (collectively “the Departments”) jointly released a proposed rule that would require insurers to expand coverage of and eliminate cost sharing on certain
2024 Election Results Could Mean Significant Restrictions on Reproductive Rights
The 2024 elections created a bit of a mixed result for reproductive rights in the United States. A number of states passed ballot initiatives designed to increase access to abortion and reproductive health services. However, at the same time, Donald