RISE summarizes recent regulatory news, including announcements and proposals from the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS).

CMS will provide limited coverage of Aduhelm, move may lead to decrease in Medicare Part B premiums

CMS last week finalized a policy to limit coverage of the cost of the Alzheimer’s drug Aduhelm and other medicines in its class to patients enrolled in qualifying clinical trials. As part of the decision, CMS said it will provide enhanced access and coverage for people with Medicare who participate in agency-approved studies, such as a data collection through routine clinical practice or registries. Any new drugs in this class that receive traditional approval from the Food and Drug Administration (FDA) may be available in additional care settings that people with Medicare can use, such as an outpatient department.

The decision is specific to individuals who have a clinical diagnosis of mild cognitive impairment due to Alzheimer’s Disease or mild dementia with a confirmed presence of plaque on the brain. CMS said this decision is consistent with use outlined on the FDA label, but it will reevaluate the coverage policy if FDA updates the label.

“Alzheimer’s disease is a highly destructive illness that affects millions of Americans and their families. CMS has a responsibility to ensure that people with Medicare have equitable and appropriate access to therapies that are reasonable and necessary for use in the Medicare population,” CMS Administrator Chiquita Brooks-LaSure said in an announcement about the policy.

Furthermore, she said, the decision creates a pathway for people with Medicare to quickly access drugs the FDA determines have shown a clinical benefit and encourages manufacturers and trial administrators to ensure that the clinical trials recruit racially diverse participants.

The decision on Aduhelm may lead to a decrease in Medicare Part B premiums. The standard monthly premium for coverage spiked dramatically this year to ensure that Medicare would have enough in reserve to cover the cost of Biogen’s drug. Biogen initially priced the drug at $56,000 a year but has since lowered the cost to $28,200. At its original price, the cost to Medicare could have exceeded $29 billion in one year, according to a Kaiser Family Foundation analysis. In January HHS secretary Xavier Becerra instructed CMS to reassess its recommendation for the 2022 Medicare Part B premium due to the price change. The agency is expected to fully assess the cost of premiums now that it has made a final coverage decision.

Feds take steps to ease burden of medical debt

Medical debt is the largest source of debt collections in the United States, more than credit cards, utilities, and auto loans combined. To help Americans deal with the high cost of medical services, the Biden-Harris administration on Monday announced new actions to protect consumers and lessen the burden of medical debt.

As part of these efforts, HHS will request data from more than 2,000 providers on medical bill collection practices, lawsuits against patients, financial assistance, financial product offerings, and third-party contracting, or debt buying practices. HHS will then consider this information in grant-making decisions, publish topline data and policy recommendations for the public, and share potential violations with relevant enforcement agencies.

Separately the Consumer Financial Protection Bureau (CFPB) will investigate credit reporting companies and debt collectors that violate patients’ and families’ rights and hold violators accountable. Veterans Affairs (VA) will also make it easier for lower-income veterans to get their VA medical debt forgiven. Currently, veterans in financial hardship who need medical debt relief from VA must fill out a complex, paper form with complicated eligibility requirements. The application process is confusing, time-consuming, and as a result, veterans may be deterred from applying for much-needed relief. To address these problems and ensure that veterans get the relief they deserve, VA will streamline the request process, including offering an online option to apply and set a simple income threshold to qualify for relief.

Bipartisan legislation would improve Medicaid value-based purchasing drug arrangements   

Bipartisan legislation was introduced in the House last week to help facilitate patient access to high-cost drugs by decreasing barriers to value-based purchasing arrangements in Medicaid. Medicaid VBPs for Patients (MVP) Act was introduced by Reps. Markwayne Mullin (R-Okla.), Kurt Schrader (D-Ore.), and Brett Guthrie (R-Ky.). The legislation is meant to encourage companies to continue making innovative treatments and let payers and consumers reimburse them based on the treatment’s outcome, Mullin said in a statement. “For too long, policy has not caught up with reality and it’s the patients who are suffering the consequences,” he said. “Drug developers are taking extraordinary risks to invest in these groundbreaking therapies, which could easily cost millions of dollars per patient once they reach the market. Without an affordable way for payers to purchase these sometimes curative drugs, it will be nearly impossible for patients to access them. Instead of stifling innovation and competition by price setting, let’s start paying for value.”

CMS proposes to indefinitely delay start date of Radiation Oncology Model

CMS published a proposed rule Wednesday to indefinitely delay the current start date of the Radiation Oncology (RO) Model and to modify the definition of the model performance period to provide that the start and end dates of the model performance period will be established in future rulemaking. The model aims to improve the quality of care for cancer patients receiving radiotherapy (RT) and move toward a simplified and predictable payment system. RT services are currently paid through fee-for-serve payments. The model aims to test whether prospective, site neutral, modality agnostic, episode-based payments to physician group practices, hospital outpatient departments, and freestanding radiation therapy centers for RT episodes of care reduces Medicare costs while preserving or enhancing the quality of care for Medicare beneficiaries. Congress has twice delayed implementation of the model, most recently in December 2021 when it proposed the start date of January 2023. CMS said in the proposed rule that “there is a substantial cost to continue funding preparation for implementation of the RO Model in 2023. For example, funding is needed for CMS to prepare for participant onboarding, claims systems changes, and updates to the data used in the Model's design and participant-specific payment amounts, among a number of other activities. The cost of the operational funding needed to continue to prepare to implement the RO Model takes resources away from the development of other alternative payment models, particularly when it is not known whether there may be further legislative delays to the start of the RO Model.”