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On July 2, 2025, the U.S. Department of Justice (DOJ) Civil Division and the U.S. Department of Health and Human Services (HHS) jointly announced the formation of a False Claims Act (FCA) Working Group. This new initiative underscores a coordinated federal enforcement strategy focused on identifying and addressing fraud in federally funded health care programs, particularly Medicare Advantage and Medicaid managed care. The announcement comes days after Matthew R. Galeotti, Head of DOJ’s Criminal Division, announced the results of the “largest coordinated health care fraud takedown in the history of the Department of Justice”  and the creation of a “Health Care Fraud Data Fusion Center” comprised of data specialists that will “break down information silos, using coordinated data analysis to enable our investigative teams to quickly identify and dismantle emerging fraud schemes.” Taken together, these announcements demonstrate the DOJ’s effort—in both civil and criminal divisions—to strengthen its collaboration with HHS to investigate and prosecute health care fraud.Continue Reading DOJ and HHS Launch FCA Working Group: Heightened Enforcement Risk for Health Care Entities

On February 28, the Department of Health and Human Services (HHS) announced that it was rescinding the Richardson Waiver, a policy in place since 1971 which said HHS would provide notice of proposed rulemaking in certain cases where it was not otherwise required to do so by law. This announcement signals a policy shift for the agency and suggests that where permitted by law, HHS will generally now issue rules relating to “agency management or personnel or to public property, loans, grants, benefits, or contracts” without providing notice and comment to stakeholders, and may otherwise find good cause to forego notice and comment procedures.Continue Reading HHS Suggests It Will Provide Less Notice and Opportunity for Comment on Grant and Contract Rules

On June 24, 2024, the Department of Health and Human Services (“HHS”) released a final rule (“Disincentives Final Rule”) establishing disincentives for certain healthcare providers that have committed information blocking. The information blocking disincentives directly impact Medicare-enrolled healthcare providers or suppliers including hospitals, critical access hospitals, MIPS-eligible clinicians, and ACOs. The Disincentives Final Rule has been submitted to the Office of the Federal Register for publication and will become effective 30 days after Federal Register publication.Continue Reading Healthcare Providers Who Engage in Information Blocking Will Face Disincentives Described in an HHS Final Rule    

On December 13, 2023, the U.S. Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health Information Technology (ONC) released the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule.Continue Reading ONC Releases Final Rule on Information Blocking and Health IT Certification Program Updates, Including Requirements Related to AI

On September 14, 2023, the U.S. Department of Health and Human Services (“HHS”) published a proposed rule updating Section 504 of the Rehabilitation Act of 1973 (“Section 504”). The new rule entitled Discrimination on the Basis of Disability in Health and Human Service Programs or Activities(the “Proposed Rule”) is the first major regulatory update to Section 504 in nearly 50 years.  Section 504 prohibits discrimination against individuals on the basis of disability in programs and activities that receive Federal financial assistance (“FFA”) or are conducted by a Federal agency.  Section 504 covers all health care and human services programs and activities funded by HHS, from providers, like hospitals and doctors that accept Medicare or Medicare, to state child welfare programs, as well as Medicare Advantage Plans, and Medicaid Managed Care Plans.Continue Reading HHS Aims to Strengthen Anti-Discrimination Rules for Disabled Patients in New Proposed Rule

On June 27, 2023, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a final rule (“OIG Final Rule”) that implements statutory provisions for its enforcement of the information blocking penalties created by the 21stCentury Cures Act (“Cures Act”) and assessment of civil money penalties (“CMPs”) of up to $1 million per violation of information blocking for certain individuals or entities subject to the information blocking requirements.Continue Reading HHS-OIG Releases Final Rule Implementing Information Blocking Penalties

On July 25, 2023, the U.S. Departments of Labor, Treasury, and Health and Human Services (the “Tri-Agencies”) released long awaited proposed regulations (the “Proposed Rule”) and a Technical Release, which together propose new requirements for comparative analyses of nonquantitative treatment limitations (“NQTL”) under the Mental Health Parity and Addiction Equity Act of 2008 (“MHPAEA”).  On the same day, the Tri-Agencies released their annual report to Congress on implementation of MHPAEA, as required under the Consolidated Appropriations Act, 2021 (“CAA 2021”). Continue Reading New Proposed MHPAEA Rule Builds on NQTL Comparative Analysis Standards

In late November, HHS proposed long-awaited changes to regulations at 42 C.F.R. Part 2 (“Part 2”) governing the confidentiality of substance use disorder (“SUD”) records as required under the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act. Generally, HHS is attempting to align Part 2 requirements with the HIPAA (“Health Insurance Portability and Accountability Act”) Privacy Rule. The most significant changes are those to the rules governing consent for entities subject to Part 2’s restrictions to use, disclose, and redisclose Part 2 records with respect to treatment, payment, and health care operations (“TPO”) activities.Continue Reading HHS Proposed Changes Would Align Part 2 Regulations on Substance Use Disorder Records with HIPAA

President Biden signs Executive Order directing HHS to “consider additional actions to further drive down prescription drug costs”

On October 14, 2022, President Biden signed an Executive Order (EO) directing the Secretary of the Department of Health and Human Services (HHS) to consider new healthcare payment and delivery models the Center for Medicare & Medicaid Innovation (CMMI), part of the Centers for Medicare & Medicaid Services (CMS) and created by the Affordable Care Act, can test to lower drug costs and promote access to innovative drug therapies for Medicare and Medicaid beneficiaries. The EO specifies the HHS Secretary should include models that may lead to lower cost-sharing for commonly used drugs and support value-based payment initiatives that promote high-quality care. The Secretary must submit its report, describing any models selected, within 90 days of the EO’s issuance.  Continue Reading White House looks to CMMI to test new ways to lower drug prices

The Russia-Ukraine conflict is increasing the risk of ransomware attacks and other cyber threats for U.S. companies, and those in the health care industry may be targeted. In a recent analyst note from the Department of Health & Human Services (“HHS”), HHS describes the cyber capabilities of Russia, one of the world’s major cyberpowers, and analyzes two malware variants most likely to impact the U.S. health care and public health sector.
Continue Reading Increased Cyber Risk for Health Care Organizations Due to the Russia-Ukraine Conflict