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CMS Transitional Coverage for Emerging Technologies Education Session

On September 23, 2024, the Centers for Medicare & Medicaid Services (CMS) held an education session regarding the August 7, 2024 final procedural notice, which finalized the Transitional Coverage for Emerging Technologies (TCET) pathway (CMS-3421). On August 7, CMS also published final guidance documents on Coverage with Evidence Development, National Coverage Analysis Evidence Review, and […]

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Critical Access Hospitals

Critical Access Hospitals (CAHs) are vital in delivering healthcare services to the approximately 60 million Americans living in rural areas. By providing essential inpatient, outpatient, and emergency services, CAHs often become the main point of care for underserved communities located far from larger medical centers. They also operate under different Medicare Conditions of Participation than […]

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Compounding Pharmacies

In an era in which weight loss drugs dominate news headlines and telehealth platforms put prescriptions just a click away, Americans are reimagining medicine's potential—and how they access it. This has driven new interest in compounding pharmacies, which promise bespoke solutions crafted to meet individual needs and sometimes claim to deliver the chemical equivalents of [...] Read More

State Health Initiatives

As the 2024 election year unfolds, healthcare remains a priority for U.S. voters. Frustrated by gridlock at the national level, many are turning their attention to state governments, which are pursuing a variety of efforts to tackle pressing healthcare issues. Governors and state legislatures are exploring state-level solutions to healthcare issues and making policy choices [...] Read More

HHS Proposes Changes to Increase Interoperability and Modernize Public Health IT

On July 10, the Office of the National Coordinator for Health Information Technology (ONC)[1] released the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule, which would implements provisions of the 21st Century Cures Act. This proposed rule was then released by the US Department of Health and […]

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The Debate Over Patent Thickets

In July, the Senate unanimously passed legislation that would limit the number of patents drugmakers can assert for a single product. Touted as a step toward improving the affordability of medications, the legislation has highlighted the debate over the impact of "patent thickets" in drug manufacturing. The bipartisan Affordable Prescriptions for Patients Act of 2023 [...] Read More

CMS Releases Proposed Hospital Outpatient and Ambulatory Surgical Center Update for CY 2025, with New Conditions of Participation (CoPs) for Hospital Obstetrical Services

On July 10, 2024, the Centers for Medicare & Medicaid Services (CMS) issued the Hospital Outpatient Prospective Payment (OPPS) and Ambulatory Surgical Center (ASC) Payment Systems proposed rule, which proposes updates to the Medicare OPPS and ASC payment system for calendar year (CY) 2025. See the press release here and the fact sheet here. This […]

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Recent Supreme Court Decisions Have Implications for Healthcare Policy

  The Supreme Court concluded its 2023-2024 term with several rulings with significant implications for healthcare policy. These included overturning Chevron deference and checking the authority of administrative law judges (ALJs). Chevron deference In its joint review of Loper Bright Enterprises v. Raimondo and Relentless, Inc. v. Department of Commerce—cases about the cost of ferrying […]

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