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Healthcare & Life Sciences Insights

Discover Latham’s latest insights into the commercial, regulatory, and legal developments shaping the global healthcare and life sciences landscape.

Latham’s cross-disciplinary team delivers insightful, practical guidance and sophisticated representation to a full spectrum of healthcare and life sciences companies across the globe, on every type of transaction or dispute a company may face.

Podcasts & Webcasts

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March 12, 2025

Episode 95 — Drug Pricing: FDA in the Age of Executive Orders and DOGE

The Department of Government Efficiency, Trump executive orders, and a recent Office of Management and Budget memorandum are making drastic changes at FDA. The Latham team discusses the potential impacts on FDA approval and enforcement activities, including with respect to novel tobacco and nicotine products.

Recognition

Local Coverage Determination (LCD)

Coverage determination by a Medicare Administrative Contractor (MAC) regarding whether a particular service or item is reasonable and necessary under Medicare within such MAC’s geographical jurisdiction. MACs publish LCDs to provide guidance to the public and medical community within the MAC’s jurisdictions on the terms and conditions of Coverage for services and items. Contractors develop LCDs by considering medical literature, the advice of local medical societies and medical consultants, public comments, and comments from the provider community.

Word of the Day®

Management Services Organization (MSO)

a for-profit or non-profit corporation, general or limited partnership, or limited liability company providing a variety of services for or on behalf of one or more medical practices (or other healthcare entities such as a hospital). Generally, the services include a broad range of management, financial and administrative services, often the entire administrative requirements or “back office” of a healthcare Provider. In many cases, the MSO acquires the tangible assets of the medical practices and leases them back to the practice as part of a management services fee. The MSO may also perform services such as marketing (where permitted under state law), contract procurement and administration, and purchase of capital assets. MSOs are often established by hospitals or by hospitals in conjunction with physicians, to assist in the consolidation of medical practices and the business development of the resulting group practice. An MSO created by a hospital and physicians is not an integrated organization, as no merger or consolidation directly occurs between the hospital and medical practice.

Word of the Day®

Medicaid

a federal health insurance program authorized by Title XIX of the Social Security Act that is jointly funded by the federal and respective state governments, and administered by the state. The program provides health insurance and other services to persons of all ages whose income and resources meet means-tested eligibility criteria determined by each state and approved by CMS. Recipients of Medicaid must be US citizens or permanent residents. The scope of Coverage provided by the various state Medicaid programs must meet certain minimum criteria established in federal law and regulations; however, payment methodologies and other administrative aspects of the Medicaid program are left to the respective state. The ACA significantly expanded both eligibility for and federal funding of Medicaid.

Word of the Day®

Purple Book

a publication that lists Biological Products (Biologics), including Biosimilar and Interchangeable Biological Products licensed by the FDA. This list includes the date when the Biological Product was licensed by the FDA. It does not include a list of the Patents associated with the approved Biological Products. See Orange Book.

Word of the Day®

Quality Agreement

an agreement between two parties, often in conjunction with a manufacture, supply or other agreement, which delineates product or project parameters and Specifications and specifies each party's responsibilities thereto.

Word of the Day®