In the Lede
The Centers for Medicare and Medicaid Services (CMS) released a proposed National Coverage Determination (NCD) decision memorandum that would cover Food and Drug Administration (FDA)-approved monoclonal antibodies that target amyloid for the treatment of Alzheimer’s disease through coverage with evidence development (CED) – which means that FDA-approved drugs in this class would be covered for people with Medicare only if they are enrolled in qualifying clinical trials. If the proposed National Coverage Determination is finalized, CMS will review each submitted clinical trial to determine whether it meets the criteria specified in the proposed National Coverage Determination. In addition to CMS-approved trials, National Institutes of Health (NIH)-sponsored clinical trials would be covered under this proposed National Coverage Determination as well. Medicare patients participating in these trials would be eligible to receive coverage of the drug, related services, and other routine costs, which may include PET scans if required by a clinical trial protocol. Currently, Aduhelm™ (aducanumab) is the only monoclonal antibody directed against amyloid beta approved by the FDA for the treatment of Alzheimer’s disease. Currently, in the absence of a national coverage policy, the Medicare Administrative Contractors, which are local contractors that pay Medicare claims, decide whether the drug is covered for a Medicare patient on a claim-by-claim basis. The proposed National Coverage Determination is open to public comment for 30 days. After reviewing all comments received on the proposed determination, CMS will announce its final decision by April 11, 2022.
Prior to the release of the proposed CMS National Coverage Determination, Health and Human Services Secretary Xavier Becerra issued a statement instructing the agency to reassess its recommendation for the 2022 Medicare Part B premium "given the dramatic price change of the Alzheimer’s drug, Aduhelm." Becerra noted that "with the 50% price drop of Aduhelm on January 1, there is a compelling basis for CMS to reexamine the previous recommendation.”
In November, CMS announced that the standard monthly premium for Medicare Part B enrollees will be $170.10 for 2022, an increase of $21.60 from $148.50 in 2021. According to CMS, about half of the Part B premium increase is because of contingency planning for costs associated with possible Medicare coverage of Aduhelm, which received accelerated approval by the FDA in June.
At the Agencies
The Department of Health and Human Services (HHS) announced a requirement for insurance companies and group health plans to cover the cost of over-the-counter, at-home COVID-19 tests, so that people with private health coverage can get them for free. The new coverage requirement means that most consumers with private health coverage can go online or to a pharmacy or store, buy a test, and either get it paid for up front by their health plan, or get reimbursed for the cost by submitting a claim to their plan. Beginning January 15, 2022, individuals with private health insurance coverage or covered by a group health plan who purchase an over-the-counter COVID-19 diagnostic test authorized, cleared, or approved by the Food and Drug Administration (FDA) will be able to have those test costs covered by their plan or insurance. Insurance companies and health plans are required to cover eight free over-the-counter at-home tests per covered individual per month. A family of four, all on the same plan, would be able to get up to 32 of these tests covered by their health plan per month. There is no limit on the number of tests, including at-home tests, that are covered if ordered or administered by a healthcare provider following an individualized clinical assessment, including for those who may need them due to underlying medical conditions. Over-the-counter test purchases will be covered in the commercial market without the need for a healthcare provider’s order or individualized clinical assessment, and without any cost-sharing requirements such as deductibles, co-payments or coinsurance, prior authorization, or other medical management requirements. As part of the requirement, HHS is incentivizing insurers and group health plans to set up programs that allow people to get the over-the-counter tests directly through preferred pharmacies, retailers or other entities with no out-of-pocket costs. Insurers and plans would cover the costs upfront, eliminating the need for consumers to submit a claim for reimbursement. When plans and insurers make tests available for upfront coverage through preferred pharmacies or retailers, they are still required to reimburse tests purchased by consumers outside of that network, at a rate of up to $12 per individual test (or the cost of the test, if less than $12). For example, if an individual has a plan that offers direct coverage through their preferred pharmacy but that individual instead purchases tests through an online retailer, the plan is still required to reimburse them up to $12 per individual test. Consumers can find out more information from their plan about how their plan or insurer will cover over-the-counter tests.
The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would make updates to the Medicare Advantage (MA) and Medicare Part D programs aimed at lowering out-of-pocket prescription drug costs for beneficiaries and improving price transparency and market competition. The proposed rule would improve beneficiaries’ experiences with MA and Part D, including individuals who are dually eligible for Medicare and Medicaid, by holding MA and Part D plans to a higher standard in offering benefits and improving health equity in the programs. Noting that in recent years, more Part D plans and pharmacies have entered into arrangements called price concessions – in which plans pay less money to pharmacies for dispensed drugs if the pharmacies do not meet certain metrics – CMS raised concerns about the lack of transparency with these arrangements that have not yielded lower prices to beneficiaries at the point of sale. CMS is proposing a policy that would require Part D plans to apply all price concessions they receive from network pharmacies to the point of sale, so that the beneficiary can also share in the savings. Specifically, CMS is proposing to redefine the negotiated price as the baseline, or lowest possible, payment to a pharmacy, effective January 1, 2023. In addition, the proposed rule would:
- Strengthen oversight of third-party marketing organizations to detect and prevent the use of deceptive marketing tactics to enroll beneficiaries in MA and Part D plans, reinstate the inclusion of a multi-language insert in specified materials to inform beneficiaries of the availability of free language and translation services, and codify enrollee ID card standards.
- Revise and clarify timeframes and standards associated with disasters and emergencies to ensure that beneficiaries have uninterrupted access to needed services.
- Add Star Ratings (2.5 or lower), bankruptcy or bankruptcy filings, and exceeding a CMS designated threshold for compliance actions as bases for CMS denying a new application or a service area expansion application.
- Require that plan applicants demonstrate they have a sufficient network of contracted providers to care for beneficiaries before CMS will approve an application for a new or expanded MA plan.
- Reinstate MLR reporting requirements that were in effect for contract years 2014 – 2017 by requiring MA organizations and Part D sponsors to report the underlying cost and revenue information needed to calculate and verify the medical loss ratio (MLR) percentage and remittance amount, if any.
- Require that MA organizations report the amounts they spend on various types of supplemental benefits not available under original Medicare (e.g., dental, vision, hearing, transportation).
The proposed rule also takes steps to improve experiences for dually eligible beneficiaries who are enrolled in Dual Eligible Special Needs Plans (D-SNPs). The proposed rule would:
- Require that MA organizations with a D-SNP establish, maintain, and consult with one or more enrollee advisory committees to ensure the experiences of people with both Medicare and Medicaid are considered in plan decision making.
- Simplify materials that describe how to access Medicare and Medicaid services and streamline the grievance and appeals processes in certain D-SNPs.
- Change MA cost-sharing rules that would result in more equitable payments to providers who serve dually eligible individuals and may improve dually eligible individuals’ access to providers.
In order to increase understanding of issues related to access to behavioral health care for enrollees in MA plans, CMS is seeking feedback on the challenges with building behavioral health provider networks within MA health plans and the overall impact of potential CMS policy changes on network adequacy and behavioral health access in MA plans.
HHS touted that more than 13.8 million consumers have signed up for 2022 healthcare coverage through the Affordable Care Act (ACA) Health Insurance Marketplaces, on HealthCare.gov and State-based Marketplaces (SBMs), according to the December National Snapshot from the Centers for Medicare and Medicaid Services (CMS). This year's Open Enrollment Period, which started on November 1, 2021, and ends on January 15, 2022, continues to outpace previous years’ enrollment, including a 21% increase in plan selections through December 15, 2021, compared to the last year’s Open Enrollment in the 33 states using the HealthCare.gov platform. Of the 13.8 million people who have signed up for 2022 health coverage, over 9.7 million people enrolled in or being automatically re-enrolled in Marketplace coverage in the 33 states with Marketplaces using HealthCare.gov for 2022 through December 15, 2021. The 18 SBMs that use their own platforms reported to CMS that through December 25, 2021, more than 4 million people selected plans or were automatically re-enrolled in a plan for 2022 health coverage, which is an increase of 240,000 consumers since the last published report. About 2 million enrollees were new consumers, while more than 11.7 million were returning consumers.
CMS announced that it will begin posting weekend staffing and staff turnover information for each nursing home on the Medicare.gov Care Compare website. For weekend staffing, the information will include the level of total nurse and registered nurse (RN) staffing on weekends provided by each nursing home over a quarter. For staff turnover, the website will have the percent of nursing staff and number of administrators that stopped working at the nursing home over a 12-month period. This information will be added to the Care Compare website in January 2022 and used in the Nursing Home Five Star Quality Rating System in July 2022.
In the News
New York Times: Medicare Proposes to Sharply Limit Coverage of the Alzheimer’s Drug Aduhelm; Criticized by Senators, U.S. Health Officials Defend Omicron Response
Politico: Biden administration lays out rules for reimbursing at-home Covid tests
Kaiser Health News: App Attempts to Break Barriers to Bankruptcy for Those in Medical Debt