In the days and weeks leading up to President Biden’s inauguration, the Department of Health and Human Services (HHS)—under the prior administration—issued a number of rules and regulations that affect cancer care delivery. Many of those rules and regulations are now subject to review by the new administration and/or Congress.
The Biden administration issued a regulatory freeze on all rules, guidance, and other agency actions that had not taken effect prior to noon Eastern Time on January 20, 2021. If a rule is pending or not yet published in the Federal Register, the new administration may withdraw the rule or review it before sending it to the Federal Register and for implementation.
Implementation of rules that have been published in the Federal Register but have not yet taken effect may be delayed for 60 days. During the delay, the administration may open a 30-day comment period to gather stakeholder feedback on the rules. Alternatively, if no further action is needed, the rule, proposal, or guidance will be considered active and effective.
In addition to the Biden Administration’s regulatory freeze, the Congressional Review Act permits the incoming Congress to review final rules issued within the first 60 days of the new Congress as well as rules issued during the last 60 days of the previous Congress.
The Association for Clinical Oncology (ASCO) submitted comments on a number of rules that could potentially be affected by the Administration’s regulatory freeze or the Congressional Review Act, including:
- Medicare Coverage of Innovative Technologies final rule—Codifies the definition of “reasonable and necessary” and finalizes a policy to cover devices that have received Food and Drug Administration marketing authorization under the breakthrough pathway if the devices fall within a defined benefit category. Read ASCO’s comments and the final rule.
- Electronic Prior Authorization for Medicaid, CHIP, and Qualified Health Plans final rule—Requires payers to build, implement, and maintain APIs for communicating prior authorization requests and responses between these payers and providers and their patients. Read ASCO comments and the final rule.
- Medicare Advantage and Part D final rule—Requires a real-time benefit look-up tool providing enrollees with real-time formulary and benefit information, permits a second “Preferred,” specialty tier in Medicare Part D, and establishes pharmacy performance measure reporting requirements. Read the final rule.
The previous Administration’s updates to existing Center for Medicare & Medicaid Innovation models could also be overturned by the Biden Administration. ASCO would like to see the Administration withdraw proposed changes outlined in the 2022 Request for Applications (RFAs) for the Part D Payment Modernization Model that could seriously weaken protections for the six “protected classes” under Part D, and allow formularies to maintain one drug per class instead of the current requirement for two drugs per class across non-protected classes. The voluntary Model, which began on January 1, 2020, currently has two participants and is open to eligible standalone Prescription Drug Plans and Medicare Advantage-Prescription Drug Plans that are approved to participate.
ASCO is closely monitoring all regulatory changes that impact oncology providers and individuals with cancer and will continue to advocate for policies that support high-quality, equitable patient care and the physicians that provide it.
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