Department of Health & Human Services

This week, in a significant win for the American Hospital Association plaintiff, the U.S. District Court for the Northern District of Texas issued an opinion vacating the Department of Health and Human Services’ (“HHS”) guidance on the use of online tracking technologies under HIPAA. At the heart of the dispute was the guidance released by HHS in December of 2022 and then updated again in March of 2024 (collectively, the “Guidance”), which suggested that information collected from unauthenticated website visitors could be considered protected health information (“PHI”) under HIPAA. The Guidance was challenged by hospitals and healthcare providers who argued it exceeded HHS’ statutory authority under HIPAA and imposed unreasonable compliance burdens.Continue Reading HIPAA Web Tracking Guidance Vacated

On June 6, 2024, California Attorney General Rob Bonta announced that he led a multistate coalition of eleven (11) state attorneys general in in submitting a comment letter (the “Comment Letter”) in response to the Federal Trade Commission, the U.S. Department of Justice, and the U.S. Department of Health and Human Services’ (together the “Agencies”) request for information regarding consolidation in healthcare by private equity. On March 5, 2024, the Agencies issued a “Request for Information on Consolidation in Healthcare Markets,” on the same day the Agencies hosted a public workshop regarding the impact of private equity investment in the healthcare system. Continue Reading California Attorney General Advocates for Greater Antitrust Enforcement in Private Equity in Healthcare

Almost 40 years after its passing, the Emergency Medical Treatment and Active Labor Act (EMTALA) remains not only a key consideration for hospitals with emergency departments, but also a significant federal enforcement priority. EMTALA requires hospitals with emergency departments that participate in Centers for Medicare and Medicaid Services (CMS) programs to provide medical screening, stabilizing treatment and transfer for patients with emergency medical conditions (EMCs) and women in labor.Continue Reading EMTALA: In the Spotlight

Most Medicare Advantage (“MA”) beneficiaries rely on agents and brokers to help them navigate the complex process of selecting a health plan that will meet their needs. In exchange, brokers and agents received certain fixed payments set by Medicare, as well as, in some cases, significant additional payments from health plans. Concerned over the potential for abuse, these arrangements have been the subject of Congressional scrutiny and an enforcement priority for both the Department of Justice (“DOJ”) and the Department of Health and Human Services Office of the Inspector General (“HHS OIG”). The Biden Administration and the Centers for Medicare & Medicaid Services (“CMS”) are tackling this issue head-on in a recently published final rule that addresses both marketing tactics and compensation methodologies used by Medicare Advantage organizations (“MAOs”) to pay MA agents or brokers.[1]Continue Reading Increased Scrutiny into Agents & Brokers in the Medicare Advantage Space

On March 28, 2024, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), announced that it is extending the temporary special enrollment period (the Unwinding SEP) for prior beneficiaries of Medicaid and Medicaid-expansion Children’s Health Insurance Programs (CHIP) to enroll in the Health Insurance Marketplace (Marketplace). The Unwinding SEP was previously scheduled to terminate on July 31, 2024, but now the end date is extended to November 30, 2024. This 4-month extension will help millions maintain insurance coverage as they navigate their new post-pandemic eligibility statuses.Continue Reading Continuity in Coverage: CMS Extends the Unwinding SEP & Issues Final Rule for Medicaid and CHIP Enrollment

The American people deserve to know that the insurance companies receiving more than $700B annually in taxpayer funds are working to ensure you receive effective, high-quality care. Remember, you have rights and options to ensure you receive the care you deserve.”Continue Reading OIG Sparks Public Excitement about Managed Care and Alludes to Incoming Enforcement Guidance

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