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 Tuesday, January 9, 2024, the Centers for Medicare & Medicaid Services (“CMS”) approved a request from New York State (“NYS”) to amend its Medicaid section 1115(a) demonstration (the “Demonstration Amendment”),[1] which will allow for important expansion of the NYS Medicaid program, including:Continue Reading 2024 Brings Expansion to Medicaid in New York State

Congress passed the Corporate Transparency Act (the “CTA”) in 2021 with the aim of enhancing transparency in entity structures and ownership as well as combating terrorism, money laundering, and other forms of corporate misconduct. This sweeping new rule is designed to cast a wide net over entities that, except in the case of taxes, do not regularly report to federal agencies (i.e., non-publicly traded entities), regardless of the degree to which they are already regulated at the state level. This post specifically speaks to medical groups and management services organizations (“MSOs”) that now need to navigate the new CTA requirements and account for their complex contractual relationships (e.g., management services agreements, equity restriction or succession agreements). For additional information on a particular topic, links to helpful resources have been provided in the footnotes.Continue Reading The Corporate Transparency Act: A Reporting Guide for Medical Groups and MSOs

On December 13, 2022, the Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule, titled Advancing Interoperability and Improving Prior Authorization Processes (“Proposed Rule”), to improve patient and provider access to health information and streamline processes related to prior authorizations for medical items and services. We provided key information about that proposed rule on our website here. Then, on January 17, 2024, CMS issued a final rule, titled CMS Interoperability and Prior Authorization (“Final Rule”), which affirms CMS’ commitment to advancing interoperability and improving prior authorization processes.Continue Reading CMS Finalizes its Proposal to Advance Interoperability and Improve Prior Authorization Processes

1. Higher Jurisdictional Thresholds For HSR Filings

On January 22, 2024, the Federal Trade Commission announced revised, higher thresholds for premerger filings under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act). The jurisdictional thresholds are revised annually, based on the change in Gross National Product (GNP).Continue Reading Higher Jurisdictional and Filing Fees Thresholds for HSR Act Premerger Notifications and Interlocking Directorates Announced

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

Will your business have to go through the new Office of Health Care Affordability (OHCA) reporting regime for material healthcare transactions? What would such a filing involve, and how long would it take to complete the process? Those questions will be among key discussion items addressed in Sheppard Mullin’s upcoming webinar on February 7, 2024, co-sponsored with America’s Physician Groups and Moss Adams LLP. As we have highlighted in our blog series[1] on SB 184 and OHCA throughout the past year, OHCA’s recently finalized cost and market impact review (CMIR) regulations set forth the framework for OHCA’s authority to receive advance notice of and review a large scope of healthcare transactions in the coming months, reflecting a dramatic change to California’s healthcare regulatory landscape moving forward. Please tune in to this important webinar where our knowledgeable presenters will present an overview of the key components and practical considerations surrounding this new law, including:Continue Reading Webinar: New OHCA Rules Requiring Notice and Review of Material Healthcare Transaction