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 FTC Hosts Workshop on Private Equity in Health Care
On March 5, 2024, the Federal Trade Commission (“the FTC”) hosted a public workshop titled “Private Capital, Public Impact: An FTC Workshop on Private Equity in Health Care”, which covered the impact of private equity investment on the health care system. The workshop included panelists from the FTC, the Department of Justice (“the DOJ”), the Department of Health and Human Services (“HHS”) (together, “the Agencies”), academic thought-leaders, and health care professionals. On the same day as the workshop the Agencies launched a “Cross-Government Inquiry on Impact of Corporate Greed in Health Care,” issuing a Request for Information (“RFI”) seeking public comment on health care deals involving private equity firms, including deals that would not be reportable under the Hart-Scott-Rodino Act. The Agencies will use the RFI to inform future enforcement and policy decisions related to health care consolidation. The public has 60 days to submit comments to the Agencies.Continue Reading The FTC Hosts Workshop on Private Equity in Health Care
Webinar: Navigating Increased Scrutiny for Health Care Deals in 2024
Are you considering a transaction in the healthcare industry? Continue Reading Webinar: Navigating Increased Scrutiny for Health Care Deals in 2024
District Court Elucidates the Meaning of “to Induce” Under the Federal Health Care Program Anti-Kickback Statute
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
Recent Healthcare-Related Artificial Intelligence Developments
AI is here to stay. The development and use of artificial intelligence (“AI”) is rapidly growing in the healthcare landscape with no signs of slowing down.Continue Reading Recent Healthcare-Related Artificial Intelligence Developments
Recent Patent Trial and Appeal Board Approaches to Patent Claims on Medical Technology Implementing AI
First published by ALM / Law.com in The Intellectual Property Strategist.Continue Reading Recent Patent Trial and Appeal Board Approaches to Patent Claims on Medical Technology Implementing AI
2024 Brings Expansion to Medicaid in New York State
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
The Corporate Transparency Act: A Reporting Guide for Medical Groups and MSOs
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
CMS Finalizes its Proposal to Advance Interoperability and Improve Prior Authorization Processes
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
Higher Jurisdictional and Filing Fees Thresholds for HSR Act Premerger Notifications and Interlocking Directorates Announced
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
Comment Period for the No Surprises Act Proposed Rule, “Federal Independent Dispute Resolution (IDR) Operations,” Will Reopen
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