Note: This article was updated July 6.
For drugs manufactured to slow the progression of Alzheimer’s disease, Medicare will offer coverage with certain qualifications, according to a recent CMS announcement.
The new policy especially is relevant because the FDA’s first full approval of an Alzheimer’s disease drug may be only a month or so away. Assuming any such drug gains full approval, Medicare will provide Part B coverage if the treating physician is participating in a registry, a CMS news release says (Update: The FDA granted full approval on July 6.)
“There is strong precedent for using registries to gather more information on a newly approved treatment,” including “how these drugs work in the real world,” the news release states.
“Clinicians will be able to submit this evidence through a nationwide, CMS-facilitated portal that will be available when any product gains traditional approval and will collect information via an easy-to-use format. This method, and any others that may follow, will adhere to robust privacy protections in accordance with applicable federal laws and regulations, including HIPAA.”
The FDA thus far has approved the Alzheimer’s disease drugs Aduhelm and Leqembi on an accelerated basis. Approval through the traditional process, which would make the drug eligible for Medicare coverage, could happen in July for Leqembi.
Update: Following approval of Leqembi for the treatment of mild cognitive impairment or mild Alzheimer’s-related dementia, Medicare coverage of the drug is available as long as the patient’s clinical team is participating in an approved registry, according to a CMS statement.
The approval comes with a highlighted warning about a possible link between the drug and amyloid-related imaging abnormalities, which can cause brain swelling.
Since its June 1 update regarding coverage of monoclonal antibody treatments that are targeted at Alzheimer’s disease, CMS has responded to concerns about confusion over how registries would work by putting out additional information, including a link to a CMS-sponsored registry. In a newly released fact sheet (available via download), CMS clarified that participation in the registry is free. Information is to be submitted from a patient’s medical record in five installments, with intervals of six months between submissions.
Providers can choose to participate in a different registry for Leqembi as long as it has been approved by CMS. The fact sheet also describes the coding and other information that should be included on claims, which can be submitted starting July 25.
An evolving set of criteria
The coverage policy expands 2022 guidelines that restricted Medicare coverage of Biogen’s Aduhelm (aducanumab), along with any future drugs in the same class, to patients who were enrolled in qualifying clinical trials under the “coverage with evidence development” pathway.
Although the updated policy is “an important signal that CMS wants to improve access to FDA-approved treatments, registry as a condition of coverage is an unnecessary and potentially harmful barrier,” the Alzheimer’s Association said in a written statement.
The American Academy of Neurology on June 12 submitted a letter to CMS arguing that patients meeting certain clinical criteria should be eligible for coverage regardless of whether their provider participates in a registry.
Both of the new drugs are used to treat early-stage Alzheimer’s disease by reducing amyloid beta plaque in the brain. Leqembi (lecanemab, manufactured by Eisai and Biogen) has not faced the same level of criticism as Aduhelm did in some circles last year when complaints targeted both Biogen’s initial price and the FDA’s approval process.
Aduhelm originally was priced at $56,000 for a year’s worth of treatment before Biogen cut the price in half following the initial blowback. Leqembi’s price is $26,500.
Context on the new policy
During a House subcommittee hearing in late April, CMS Administrator Chiquita Brooks-LaSure sought to explain the agency’s rationale for the coverage decision.
“In this case for the treatment of Alzheimer’s disease, [traditional approval] means the FDA has made a determination that [the drug] will affect the disease itself,” Brooks-LaSure said, implicitly drawing a contrast with accelerated approval, which for the two Alzheimer’s disease drugs was based on efficacy in clearing amyloid plaque.
“And when FDA fully approves drugs for Alzheimer’s disease, CMS will cover it more broadly,” she added. “Once the drug is fully approved by the FDA, we encourage doctors and ask doctors who are prescribing the medication to make sure that information is available through a registry, and we are doing that because we need to continue to develop evidence of and understand the impact of a drug.”
Subcommittee members from both sides of the aisle criticized the policy during the hearing. For example, Rep. Anna Eshoo (D-Calif.) questioned whether adequate information about registries was being communicated to stakeholders. Qualified registries are established by private entities such as institutes that funnel resources toward the fight against specific diseases.
“If doctors don’t know, if patients don’t know and Medicare doesn’t really seem to know what this registry entails,” Eshoo said, “how are Medicare patients going to get the drug potentially beginning in July?”
To address such concerns, CMS said it is working with organizations that are getting ready to launch Alzheimer’s disease registries.
Prospective coding changes for hospital services
In other news, CMS held a virtual public meeting June 1 to solicit input on FY24 potential changes to the HCPCS code set. On the agenda were requests or proposals to:
- Delay or reverse the scheduled Dec. 31, 2024, termination of three S codes associated with breast reconstruction surgery
- Establish new codes covering the transportation of clinical staff and equipment to provide evaluation and management services in a patient’s home
- Establish new codes for:
- Bilateral hip orthosis
- Items related to PainShield MD ultrasound procedures
- Sodium phenylacetate and sodium benzoate injections
- Determine the Medicare payment policy for RelieVRx lower back pain treatment
- Evaluate 2023 codes pertaining to drugs approved by the FDA under the 505(b)(2) or biologics license application pathway and products “not otherwise classified”
- Establish permanent codes for supplies that received a K code effective in 2020 through 2022