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CMS Weighs Fallback Options In Case 340B Court Appeal Fails

CMS plans to vigorously defend in court its cuts to hospital pay for 340B drugs, but the agency is also weighing fallback options in case the D.C. Circuit Court of Appeals sides with 340B hospitals.

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Hospitals have asked a federal court to update them on their lawsuit over deep reimbursement cuts for clinic visits at off-campus facilities after CMS last month proposed a 2020 hospital outpatient pay rule that doubled down on those cuts.

House Ways & Means Democrats are scheduled to meet Sept. 10 and 11 to talk about drug pricing and surprise billing legislation, and the committee might even mark up a bill mid-month, but it’s unclear which measures might be marked up or what they might entail.

A new group led by the Biotechnology Innovation Organization (BIO) is urging Congress to create additional incentives for drug and biologic makers to develop innovative antibiotics, starting with passage of the Medicare add-on payments included in the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019.

A vaping product manufacturer and a newly formed trade association representing the vaping industry are asking a federal court in Mississippi to overturn FDA’s deeming rule so that the agency no longer has authority to regulate electronic nicotine delivery system (ENDS) products, including e-cigarettes.

Three former FDA commissioners are calling for CMS to test using data from multiple sources to gauge outcomes of value-based pay models for high-cost drugs and biologics.

Senate Homeland Security & Government Affairs Committee ranking Democrat Gary Peters (MI) is concerned FDA doesn’t have the data it needs to mitigate drug shortages, which he says can drive up prices and hurt patients and hospitals.

The number of Medicaid-covered prescriptions for buprenorphine, a key drug used to treat opioid addiction, increased dramatically in states that expanded Medicaid under the Affordable Care Act while remaining relatively static in non-expansion states, according to a new study from researchers at the Urban Institute.

Democratic staff of the House Energy & Commerce Committee are not negotiating on drug pricing with staff of the Senate Finance Committee, sources say, even though Finance Chair Chuck Grassley (R-IA) said bicameral drug-pricing talks would occur in August.

E-cigarette maker JUUL Labs has dropped its membership with the Vapor Technology Association, saying Tuesday (Aug. 20) there are “too many critical policy issues” on which JUUL and the association disagree.

Three former FDA commissioners are calling on FDA, CMS and Congress to work with stakeholders to increase the use of real-world evidence (RWE) and real-world data (RWD) in order to improve the evidence base for new drugs and biologics; refine regulatory decisions by FDA; and promote value-based payment models to make health care more affordable.