Department of Health & Human Services

The U.S. Department of Health and Human Services (HHS) and the Substance Abuse and Mental Health Services Administration (SAMHSA) recently released the long anticipated Final Rule to revise the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations at 42 C.F.R. Part 2 (Part 2).Continue Reading HHS Announces 42 Part 2 Final Rule to Align with HIPAA

The United States District Court for the Eastern District of Virginia recently dismissed an appeal by the Pharmaceutical Coalition for Patient Access (“PCPA”) that challenged a negative opinion issued by the U.S. Department of Health and Human Services, Office of the Inspector General (“OIG”) concerning pharmaceutical manufacturers’ offers of cost-sharing subsidies to Medicare Part D (“Part D”) beneficiaries. The opinion under review was Advisory Opinion No. 22-19,[1] which we previously wrote about[2] and in which the OIG advised that if pharmaceutical manufacturers offered the proposed cost-sharing subsidies to Part D beneficiaries via PCPA, they could be subject to liability under the Federal health care program Anti-Kickback Statute (the “AKS”), even though the proposed subsidies would not violate the Civil Monetary Penalty Law’s Beneficiary Inducement Prohibition (“BIP”).Continue Reading District Court Elucidates the Meaning of “to Induce” Under the Federal Health Care Program Anti-Kickback Statute

On January 17, 2024, the Departments of Health and Human Services, Labor, and the Treasury (collectively, the “Departments”) and the Office of Personnel Management issued a notice that they will reopen the period for submitting comments on the proposed rule, “Federal Independent Dispute Resolution (IDR) Operations” (the “Proposed Rule”) under the No Surprises Act (the “Act”).Continue Reading Comment Period for the No Surprises Act Proposed Rule, “Federal Independent Dispute Resolution (IDR) Operations,” Will Reopen

Last week the Federal Trade Commission (FTC) issued a press release highlighting recent and forthcoming actions by the FTC, Department of Justice (DOJ), and the Department of Health and Human Services (HHS), which they say will further promote competition, thereby lowering costs and increasing the quality of care in the U.S. health care market. In addition to highlighting recent actions by each of the agencies (e.g., the FTC’s proposed non-compete rule), the release states that the three agencies are entering into new partnerships to increase interagency cooperation and advance a “whole-of-government” approach to protect health care competition, including:Continue Reading FTC, DOJ, and HHS Announce Interagency Initiatives to Promote Healthcare Competition

On November 2, 2023, the American Hospital Association and Texas Hospital Association, in conjunction with the Texas Health Resources and United Regional Health Care System, filed suit against the Secretary of the Department of Health and Human Services (“HHS”) and the Director of the HHS Office for Civil Rights (“OCR”) regarding OCR’s guidance on the use of online tracking technologies by HIPAA entities.[i] This action and its results will impact how healthcare entities must protect and may use certain information collected on their digital sites.Continue Reading Caught in the Web: Hospital Associations Sue OCR on Third-Party Web Tracking Guidance

Late last week, the Department of Health and Human Services Office of the Inspector General (“OIG”) posted Advisory Opinion No. 23-07 affirming the broad protection available for compensation to employed physicians under the bona fide employee exception and safe harbor to the federal Anti-Kickback Statute (the “AKS”). The opinion highlights flexibility for healthcare providers seeking to compensate employees in ways that align incentives with their employers, and particularly for physician practices to align employed physicians with use of the practices’ ambulatory surgery center (“ASC”) capabilities.Continue Reading OIG Confirms the Broad Protection of Employee Safe Harbor

Industry stakeholders have been eagerly waiting for the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Secretary of HHS to provide more clarity on federal information blocking enforcement rules since the Office of the National Coordinator for Health Information Technology (ONC) issued its final information blocking rules in 2020.[i] Continue Reading HHS OIG Publishes Eagerly-Anticipated Federal Information Blocking Enforcement Final Rule

On June 16, 2023, nearly half of the State Attorneys General[1] penned a letter (the “Letter”) to the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) advocating for broader privacy protections surrounding reproductive health care information. Specifically, the Letter targeted the Notice of Proposed Rulemaking (the “Proposed Rule”) published by OCR in April of 2023, which proposed a number of revisions to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).[2]Continue Reading State Attorneys General Pen Letter to OCR Advocating for Greater Privacy Protection of Reproductive Health Care Information

The Department of Health and Human Services Office of Inspector General (OIG) recently announced changes to its process for informing healthcare industry stakeholders of new or updated Compliance Program Guidance (CPG). Historically, sector-specific CPG has been published in the Federal Register. Going forward, the OIG will publish all current and updated CPG on its website.Continue Reading OIG’s Modernization of Compliance Program Guidance: What to Expect

The growth of private equity and other financial sponsor investments in the health care industry has led many states across the country to adopt expansive oversight authority over health care transactions. With the enactment of New York State’s budget for the State Fiscal Year 2023-2024, signed into law on May 3, 2023, the movement for more oversight in New York is coming this summer.Continue Reading New Notice and Public Disclosure Requirements for Material Health Care Transactions in New York

The Office of Inspector General (“OIG”) within the U.S. Department of Health and Human Services (“HHS”) is responsible for detecting and preventing fraud, waste, and abuse in federal health care programs. The OIG has authority to enforce the federal Anti-Kickback Statute (“AKS”) and the Beneficiary Inducements Civil Monetary Penalty law (“CMPL”). One of the ways that the OIG utilizes its enforcement authority is through the issuance of advisory opinions. Continue Reading OIG 2022 Advisory Opinions: Year in Review