On December 28, the U.S. District Court for the Northern District of California issued a nationwide preliminary injunction blocking implementation of the Most Favored Nation (MFN) Model. The decision prevents the Centers for Medicare & Medicaid Services (CMS) from implementing the MFN Model until the agency completes the notice and comment procedures required by the Administrative Procedure Act, which requires CMS to solicit comments on a proposal and respond to those comments before finalizing any rules implementing a new payment model. ASCO submitted an amicus curiae brief in support of the this litigation, and others, to enjoin implementation of the model.
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On December 23, 2020, ASCO submitted comments to the Centers for Medicare & Medicaid Services (CMS) in response to the Reducing Provider and Patient Burden and Promoting Patients' Electronic Access to Health Information proposed rule. This rule builds on the CMS Interoperability and Patient Access final rule and would require Medicaid and Children’s Health Insurance Program (CHIP) managed care plans, state Medicaid and CHIP fee-for-service programs, and Qualified Health Plan (QHP) issuers on federally facilitated insurance exchanges to improve the electronic exchange of health care data, and streamline processes related to prior authorization.
Feasibility assessments (FA) for clinical trials are conducted to establish that prospective trial sites can safely and effectively meet study goals and protocol requirements, however, a new research statement by the American Society of Clinical Oncology (ASCO) asserts that current standards are “costly, inconsistent, inefficient, labor intensive, and of uncertain effectiveness.” These deficiencies ultimately result in fewer patients with timely access to clinical trials and delays in advancing novel safe and effective treatments.