The American Society of Clinical Oncology’s (ASCO) Road to Recovery Report: Learning from the COVID-19 Experience to Improve Clinical Research and Cancer Care, among other recommendations, calls for the U.S. Department of Health and Human Services (HHS) to establish a special enrollment period on the federal health insurance exchange, abandon plans that limit access to healthcare, and enact policies that enhance access to care for patients with cancer. ASCO applauds the Biden administration for its recent actions supporting policies that aim to promote and protect access to high-quality, equitable cancer care, as outlined in the “Road to Recovery” report.
For example, the acting secretary of HHS issued a letter to all state Governors indicating that the COVID-19 Public Health Emergency (PHE) will likely remain in place through the end of 2021, and that a notice of termination will likely be issued 60 days prior to termination of the PHE. This shift away from reevaluating the PHE every 90 days is meant to bring “predictability and stability” to the healthcare system, as telehealth and other flexibilities and waivers, among other temporary policy changes adopted during the pandemic, will expire at the end of the PHE.
On Thursday, January 28, 2021, President Biden issued an executive order (EO) aimed at strengthening American’s access to quality, affordable healthcare. This EO directs the HHS secretary to consider opening a special enrollment period (SEP) for the Federally Facilitated health insurance Marketplace during the COVID-19 pandemic. As a result, the Centers for Medicare & Medicaid Services (CMS) established a COVID-19 SEP for plans offered on the federal exchange from February 15, 2021 through May 15, 2021.
The EO also directs federal agencies to review policies that undermine pre-existing condition protections, reduce coverage through waivers or demonstration programs, undermine the Affordable Care Act (ACA) or make it more difficult to enroll in Medicaid, and make coverage less affordable. ASCO will closely monitor regulations and guidance the administration releases in response to this EO.
Finally, as a result of the regulatory freeze, HHS has delayed the start date of two regulations related to cancer care. The effective date of the Secure Electronic Prior Authorization for Medicare Part D final rule is delayed from February 1, 2021 to March 30, 2021. This rule aims to secure and streamline prior authorization within the Medicare Part D program by adopting the NCPDP SCRIPT Standard Version 20170171.
The effective date of the “Rebate Rule” is delayed until January 1, 2023 to give the Biden administration time to evaluate the impact of the rule on the Part D program and its beneficiaries. This rule removes safe harbor protection for reductions in price in connection with the sale or purchase of prescription drugs from manufacturers to plan sponsors under Medicare Part D, and instead aims to shift the savings to the patient.
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