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

December 7, 2023, President Biden announced new actions to promote competition in health care and to lower prescription drug costs. Of particular note is a newly unveiled framework for deciding whether the Government may exercise “march-in” rights and take a pharmaceutical company’s drug patents developed with federal funds and share them with other companies. See Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights, available here (“Draft Guidance”).Continue Reading The March on Pharmaceutical Patents?

On November 24, 2023, the U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid Services (“CMS”) published a proposed rule to modify certain Patient Protection and Affordable Care Act (“ACA”) standards that apply to issuers and Marketplaces, as well as requirements for agents, brokers, web-brokers, direct enrollment entities, and assisters that help Marketplace consumers (the “Proposed Rule”).[1] These modifications are intended to further the Biden Administration’s goals of advancing health equity by addressing disparities in access to quality care while minimizing administrative burdens and ensuring program integrity.Continue Reading CMS Promotes Health Equity through Marketplace Standards and More in New Proposed Rule

Sheppard Mullin’s Healthcare Team has launched “Health-e Law”, a new podcast dedicated to the interaction between technology and health. Each episode will cover innovations that impact health care in bite-sized, 15-minute episodes, that will keep listeners updated on the fascinating health-tech topics and trends of the day. Our Digital Health Team, alongside experts and thought leaders, will share how innovations can solve some of health care’s (and maybe the world’s) biggest problems, if properly navigated. Health-e Law is hosted by partners Sara Shanti and Phil Kim and associate Michael Sutton.Continue Reading Health-e Law Launches: New Podcast Covers Health-Tech and Law

In the final days of November, the Office of Health Care Affordability (OHCA) published three updates related to its proposed regulations regarding the review of certain healthcare transactions in California:Continue Reading OHCA Published Near-Final Draft of Regulations Requiring Notice and Review of Material Healthcare Transactions in 2024

The Department of Health and Human Services (HHS) and the Department of Justice (DOJ) recently released its “Health Care Fraud and Abuse Control Program Annual Report for Fiscal Year 2022” (the “Report”), highlighting continued enforcement and recovery actions under the Health Care Fraud and Abuse Control Program (HCFAC). During fiscal year 2022 (FY 2022), over $1.7 billion was returned through HCFAC’s enforcement actions.Continue Reading HHS & DOJ FY 2022 Enforcement Targeted Fraud in COVID-19, Telemedicine, Opioid and Prescription Drugs, and Substance Use Treatment Centers, Among Other Initiatives

On November 17, 2023, the U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid Services (“CMS”) will publish a final rule requiring Medicare skilled nursing facilities (“SNFs”) and Medicaid nursing facilities (“Facilities”) to provide more detailed ownership, managerial and other information on Form CMS-855A (the “Final Rule”).[1] The Final Rule also includes new definitions of “private equity company” and “real estate investment trust” for Medicare enrollment purposes for all Medicare institutional providers and suppliers.Continue Reading CMS Issues a Final Rule Requiring Nursing Facilities and Other Providers and Suppliers to Disclose Additional Ownership Information

The Healthcare Real Estate team at Sheppard Mullin had the privilege of attending the Connect Healthcare Real Estate Conference in Newport Beach, California, on September 28, 2023. This event provided an invaluable opportunity for our team to engage with thought leaders and professionals within the industry. Here are the key takeaways that resonate with our commitment to advancing healthcare real estate solutions:Continue Reading Enhancing Patient Care and Business Strategies: Insights from Connect Healthcare Real Estate Conference

The Healthcare Real Estate Team at Sheppard Mullin attended the SoCal Healthcare Real Estate Summit on October 18, 2023. This event offered valuable insights into critical issues for health systems and those involved in catering to their real estate requirements. Here are the key takeaways from the summit:Continue Reading Transforming Healthcare Real Estate: Insights from the SoCal Summit