House Budget Committee Republicans Call For New CMMI Cost Evaluation

House Budget Committee Republicans are calling for an investigation into the Center for Medicare and Medicaid Innovation after a September Congressional Budget Office report highlighted high spending from CMMI in its first decade. The Republicans’ call for an updated cost report is based on CBO’s findings last year that CMS’ innovation center increased spending by $5.4 billion in its first decade, despite initial estimates that it would save $2.8 billion during that timeframe. CBO projected at the time the center’s...
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CMS Issue: 
Inside CMS - 05/02/2024
CMS Volume: 
Vol. 27, No. 18
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Admin Finalizes ACA Non-Discrimination Reg

The Biden administration Friday finalized a long-awaited regulation that restores the scope of the Affordable Care Act’s section 1557 on non-discrimination protections and ensures health care programs that get federal funding do not discriminate on the basis of sex, gender identity or pregnancy status, after the rule had been rolled back by the Trump administration. The final rule also ensures that patients with Limited English Proficiency have access to cost-free assistance, clarifies that the rule applies to use of artificial...
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CMS Issue: 
Inside CMS - 05/02/2024
CMS Volume: 
Vol. 27, No. 18
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Pfizer Accused Again Of Patent Infringement By GSK Over mRNA Vaccines

GlaxoSmithKline is suing Pfizer and BioNTech over alleged infringement of multiple GSK-owned patents in the creation of mRNA vaccines for COVID-19, the latest in a series of legal disputes between vaccine makers on the rights to the technology at the core of vaccines developed rapidly during the pandemic, often through collaboration between industry and the federal government. GSK alleges its patents are infringed in all dosage forms of the companies’ main mRNA vaccine for COVID-19 and subsequent bivalent vaccines for...
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IDP Issue: 
Inside Drug Pricing - 04/29/2024
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Vol. 7, No. 18
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Menthol Rule Faces Indefinite Delay Despite FDA Promises

FDA’s proposed rule on banning menthol cigarettes will not be finalized in the near future, the White House confirmed Friday (April 26) after months of delays, in a decision likely tied to electoral concerns ahead of the pending 2024 presidential election, despite robust support from FDA leadership for the proposal. Although congressional Republicans and some other stakeholders have said a ban on menthol could shift sales away from legitimate businesses and onto the black market, the decision is facing backlash...
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FDA Issue: 
FDA Week - 05/03/2024
FDA Volume: 
Vol. 30, No. 18
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Pfizer Offers Warranty Payment Approach For New Hemophilia Gene Therapy

Pfizer plans to allow payers to use a “warranty” approach to pay for its new costly gene therapy, the company announced after gaining FDA approval Friday (April 26) of Beqvez (fidanacogene elaparvovec-dzkt) for the treatment of adult patients with moderate to severe hemophilia B. In a statement Friday , Pfizer announced it will be “launching an innovative warranty program based on durability of patient response to treatment.” The wholesale acquisition cost for the treatment will be $3.5 million, making it...
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FDA Issue: 
FDA Week - 05/03/2024
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Vol. 30, No. 18
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NIH RECOVER Opens Long COVID Dataset To Researchers Via Database

Authorized researchers will have access to data from thousands of adult long COVID patients who participated in the National Institutes of Health's $1.15 billion research initiative via a centralized data access system that agency officials hope will fast-track breakthrough treatments. Yet patient-advocates insist that more funding is crucial to fully leverage this data and advance research efforts. The NIH Researching COVID to Enhance Recovery (RECOVER) Initiative released observational research data from more than 14,000 adults with long COVID on Thursday...
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FDA Issue: 
FDA Week - 05/03/2024
FDA Volume: 
Vol. 30, No. 18
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FTC Issues Controversial Breach Notification Rule Despite Two Commissioners’ Dissent

The Federal Trade Commission on Friday (April 26) finalized a controversial plan to extend the scope of its Health Breach Notification Rule to include personal health information collected by health apps and other technology that fall outside the Health Insurance Portability and Accountability Act, despite warnings from stakeholders the agency could be sued and dissenting opinions from two commissioners alleging FTC was overstepping its authority. The rule requires vendors of personal health records and related entities that are not covered...
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FDA Issue: 
FDA Week - 05/03/2024
FDA Volume: 
Vol. 30, No. 18
CMS Issue: 
Inside CMS - 05/02/2024
CMS Volume: 
Vol. 27, No. 18
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CBO, Paragon Float Entitlement Reform Ideas

The Congressional Budget Office highlighted several health-related policies the agency estimates would save hundreds of billions of dollars from 2023-2033 -- like lowering federal pay for Medicaid, reforming Medicare Advantage benchmarks, increasing Medicare Part B premiums and limiting provider taxes -- during Thursday (April 25) presentation at a conservative think tank-sponsored event on entitlement reform. The agency also noted that it still exploring the long-term effects of policies that would expand insurance coverage for anti-obesity medications and the diagnosis and...
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CMS Issue: 
Inside CMS - 05/02/2024
CMS Volume: 
Vol. 27, No. 18
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FDA Seeks Input On Ways To Update Clinical Pharmacology Policies

FDA is soliciting comments on what policy topics should be developed, prioritized or implemented by the drug center’s Office of Clinical Pharmacology (OCP) to promote effective research on drug development. The request for comment is scheduled to be published in the Federal Register Friday (April 26). FDA says in the notice it is looking for “specific, actionable policy suggestions” from stakeholders in the field of clinical pharmacology that OCP staff can implement in the near term. Areas of particular...
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FDA Issue: 
FDA Week - 05/03/2024
FDA Volume: 
Vol. 30, No. 18
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