Roundtable Joins Diverse Groups Asking Biden Administration to Continue to Protect from Surprise Bills
CMS Releases its Coverage Decision for the Controversial Alzheimer’s Drug
The Centers for Medicare and Medicaid Services (CMS) released its much-anticipated coverage decision for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease, restricting coverage to patients participating in clinical trials. The decision covers the entire class of drugs, not just the singularly approved drug Aduhelm and has implications for other drugs in this class that are currently being researched and may be approved in the coming years. In a major departure from the initial proposed coverage decision, CMS said it will not require the exact same clinical trial restrictions for drugs that are approved based on direct endpoints. That is, drugs that are approved via the accelerated approval route will have tougher clinical trial restrictions than drugs that are approved via traditional approval. Nonetheless, the entire class of drugs, according to the coverage decision, will be required to be administered with some form of clinical trial oversight. Notably, state Medicaid programs will likely have to cover the cost of the Aduhelm but may employ prior authorization requirements to curb the widespread use of Aduhelm. For dually eligible beneficiaries, Medicaid programs will not have to cover the therapy.
CMS and FDA Release a Joint Statement on Access to New and Innovative Treatments
Today, in the wake of the Centers for Medicare and Medicaid Services’ coverage decision on anti-amyloid monoclonal antibodies, CMS Administrator, Chiquita Brooks-LaSure and Commissioner of Food and Drugs, Dr. Robert Califf, released a joint statement on ensuring access to safe and effective treatments.
In their statement, Brooks-LaSure and Califf stated “ensuring the availability of innovative interventions for people is a shared priority for both CMS and FDA.” Notably, in their joint statement, Brooks-LaSure and Califf stated “CMS can conduct its own independent review to determine whether an item or service should be covered nationally by Medicare, including examining whether it is reasonable and necessary for use in the Medicare population.” This joint acknowledgment is a major development in the course of CMS-FDA relations and may play a major role in decisions product manufacturers make as they determine the course of development and payment for their product.
The Biden-Harris Administration announced (fact sheet) expanded access to COVID-19 tests to beneficiaries enrolled in Medicare Part B and Medicare Advantage plans. Beginning April 4, 2022, beneficiaries can access up to 8 tests per month for free. Coverage will last until the end of the public health emergency. Tests can be acquired at any pharmacy or health care provider that participates in the initiative. A partial list of participating providers can be found here. Additionally, there are no new Medicare enrollment processes required for providers and pharmacies to undergo to offer tests. The only requirement is that the provider must currently provide ambulatory health care services, including vaccines, lab tests, or clinic type visits to Medicare beneficiaries.
The Centers for Medicare and Medicaid Services proposed to delay the current start date of the Radiation Oncology (RO) Model to a date to be determined through future rulemaking, and to modify the definition of the model performance period to provide that the start and end dates of the model performance period for the RO Model be established in future rulemaking. Due to the public health emergency (PHE) for COVID-19, CMS had to initially postpone the start of the model. Superseding the start of the model, Congress included a provision in the Consolidated Appropriations Act of 2021 that prohibited the implementation of the RO Model before January 1, 2022. CMS then promulgated a rule pushing the start of the model back to January 1, 2022. Shortly thereafter, Congress enacted a law that included a provision that delayed the model another year. Given the multiple delays to date, and because both CMS and RO participants need to invest resources in preparation for implementation of the RO Model, CMS has decided to leave the implementation date of the RO Model vague.
The Centers for Medicare and Medicaid Services (CMS) announced the release of Calendar Year (CY) 2023 Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies (the Final Rate Notice). In CY 2023, the effective growth rate was finalized to be 4.88%, an increase from the proposed 4.75% in the 2023 advance notice. The rebasing/re-pricing increased was finalized to be .39%. The change in star ratings was 0%, Medicare Advantage Coding Pattern Adjustment 0%, Risk Model Revision 0%, Normalization factor -.81%, and MA risk score trend 3.5%, all finalized as proposed. The overall expected average change in revenue was 8.5%, an increase from 7.98%. CMS also announced updates to risk adjustment in regard to Part C, Part C End Stage Renal Disease (ESRD), PACE, and Part D. CMS solicited feedback on a number of different potential measurement concepts to advance health equity and value-based care, including enhancing current CMS efforts to report stratified Part C and D Star Ratings measures, developing a Health Equity Index to enhance the Part C and D Star Ratings program, developing a measure to assess whether plans are screening their enrollees for health-related social needs, and transforming care and driving quality through value-based contracts with providers.
CMS released two new tools to help states prepare for conducting redeterminations once the federal Public Health Emergency (PHE) ends. The first tool provides states with strategic approaches for processing Medicaid fair hearings as states resume normal eligibility and enrollment operations. The tool outlines a series of steps states can use to prepare for anticipated increases in fair hearing volume including assessing the air hearing process and capacity, reviewing strategies, and considering Requesting Mitigation Authority from CMS if needed. The second tool provides states with a summary of best practices gleaned from discussions CMS had with state Medicaid agency leadership. Key themes discussed in the tool include renewals and redeterminations, enrollee contact information, workforce capacity, outreach, partnerships, and communities.
CMS released the 2022 – 2023 Medicaid Managed Care Rate Development Guide, which provides guidance to state Medicaid agencies to develop capitation rates for Medicaid managed care organizations (MCOs). The guide provides details regarding information that must be included in actuarial rate certifications for CMS to review and approve for rating periods between July 1, 2022 and June 30, 2023. As in previous years, the guide also includes the option for states to pursue an accelerated rate review process.