Medicare Part B

Physician-administered drugs could catch some windfall due to the Inflation Reduction Act’s Medicare Part D redesign.

Much time and energy has been focused on thinking about how drug pricing, rebating and Part D plan design may shift due to changes set to finish taking effect in 2025, including new caps on enrollee out-of-pocket spend and more liability falling on plans rather than taxpayers.

But a “sleeper issue here is what all of this is going to mean for Medicare Part B drugs,” said Avalere’s Kesley Lang on a January webinar on the health policy outlook for the new year.

To help overwhelmed seniors make better Medicare Advantage plan comparisons, the Medicare Payment Advisory Commission (MedPAC) nearly a year ago began discussing the concept of standardizing a limited number of common supplemental benefits in MA. During its September public meeting, MedPAC agreed to devote a chapter of its June 2024 report to standardizing select MA benefits, while several commissioners echoed previous sentiments about striking a balance between standardization and flexibility.

At its November 2022 public meeting, the independent congressional agency considered two different approaches: (1) standardizing a limited number of common supplemental benefits, such as dental, hearing and vision, and (2) standardizing Medicare Parts A and B services, whereby plans use a limited number of benefit packages. But some commissioners at the time expressed concern about potentially hampering MA plan innovation.

The House is reportedly poised to vote soon on legislation that consolidates a host of previously introduced health care measures — including a step toward site-neutral payment reform. Aimed at stopping “price gouging” by hospital outpatient departments (HOPDs), those provisions are enthusiastically supported by payers but opposed by the hospital industry, which argues that they would result in payment reductions.

The legislation also would codify existing regulations that lay out new price transparency requirements for health plans and hospitals, and it would implement modest PBM reforms.

CMS revealed on Aug. 29 the list of the initial 10 drugs that will be subject to drug price negotiations in the Medicare program starting in 2026. However, even before the agency’s announcement, several pharmaceutical companies and other stakeholders filed lawsuits seeking to curtail the negotiation program’s implementation.

During a KFF webinar on Sept. 12, a Medicare policy expert and two attorneys discussed the legal challenges and potential ramifications.

Zachary Baron, associate director of the Health Policy and the Law Initiative at Georgetown University’s O’Neill Institute, said that if courts rule in favor of the drug manufacturers, there could potentially be changes in how Medicare reimburses hospitals and providers, among other consequences.

The Center for Medicare Advocacy and the Community Legal Services clinic at the University of the Pacific, McGeorge School of Law filed a class action lawsuit (Case 2:23-cv-01932-DB) against HHS on Sept. 8 on behalf of Medicare beneficiaries who have lost coverage of certain Medicare Part B drugs. Plaintiffs were receiving the Janssen Pharmaceutical Companies of Johnson & Johnson’s Stelara (ustekinumab) in an outpatient clinic, where the agent was administered by health care professionals and covered under Part B as an agent provided “incident to” a physician’s service due to disabilities that prevent them from self-administration. In October 2021, HHS denied coverage of Stelara under Part B because it had determined that the drug is “usually self-administered by the patient.” HHS did not notify patients about the change, and it did not require providers to issue a notice. One plaintiff had four injections of more than $40,000 each, while another had two injections of about $58,000 each, before they realized that they were responsible for the full cost of the drug. Plaintiffs are seeking “timely, adequate notice” be required when a Part B drug that has been furnished incident to a practitioner’s service is added to the self-administered drug (SAD) list, as well as a modification to Medicare allowing beneficiaries who cannot self-administer a medically necessary drug due to a disability to be able to receive Medicare-covered medications administered by a health care professional, among other requests.

Eisai Co., Ltd. and its partner Biogen, Inc. crossed over the biggest barrier in their quest to commercialize Leqembi (lecanemab) now that Medicare will cover the cost of the Alzheimer’s disease drug. The next hurdles for doctors and patients will be obtaining blood tests and PET scans for confirming amyloid pathology in the brain, genetic testing to assess APOE4 status, MRIs to monitor for amyloid-related imaging abnormalities (ARIA) and infusion centers to administer the medicine — facilities that exist, but not in the numbers and locations needed to serve all of the US patients eligible for treatment.

CMS said that it will cover the cost of Leqembi on July 6, the day that the FDA converted the amyloid protofibril-targeting antibody’s accelerated approval for the treatment of mild cognitive impairment or mild dementia associated with Alzheimer’s disease (AD) into full approval. Eisai and others believe that while uptake of Leqembi will be slow as the health care system catches up with the diagnostic, monitoring and infusion requirements associated with the therapy, Medicare coverage gives providers the confidence they need to offer those services.

CMS on June 9 revealed a list of 43 Medicare Part B drugs that will be sanctioned for having their prices increase faster than the rate of inflation, as part of the Inflation Reduction Act (IRA). The number of drugs affected is almost double the number that made CMS’s initial list, which the agency made public in March. Starting in July, beneficiaries who normally pay 20% coinsurance under Part B for the 43 drugs will see their cost sharing decline based on an inflation-adjusted price. The federal government will invoice manufacturers for 2023 and 2024 Part B inflation rebates no later than fall 2025, and those funds will be deposited into the Medicare Trust Fund.

Seven of Amgen, Inc.’s medications made the list, including its blockbuster bone cancer treatment Prolia, cancer medications Kyprolis, Vectibix and Blincyto, and Nplate for immune thrombocytopenia.

CMS on June 9 revealed a list of 43 Medicare Part B drugs that will be sanctioned for having their prices increase faster than the rate of inflation, as part of the Inflation Reduction Act (IRA). The number of drugs affected is almost double the number that made CMS’s initial list, which the agency made public in March. Starting in July, beneficiaries who normally pay 20% coinsurance under Part B for the 43 drugs will see their cost sharing decline based on an inflation-adjusted price. The federal government will invoice manufacturers for 2023 and 2024 Part B inflation rebates no later than fall 2025, and those funds will be deposited into the Medicare Trust Fund.

Seven of Amgen, Inc.’s medications made the list, including its blockbuster bone cancer treatment Prolia, cancer medications Kyprolis, Vectibix and Blincyto, and Nplate for immune thrombocytopenia.

Eisai Co., Ltd. and Biogen Inc.’s Leqembi (lecanemab) could raise Medicare Part B spending by $8.9 billion or more annually if it receives full approval from the FDA KFF found. And a report by researchers from the RAND Corp. found that Leqembi could increase spending by $2 billion to $5 billion. KFF’s projection was based on an annual list price of $26,500 and uptake among 5% of Alzheimer’s patients. The RAND report included estimates of ancillary costs, such as MRI scans. The FDA granted accelerated approval to the anti-amyloid monoclonal antibody treatment in January, and its decision on full approval is expected soon.

CVS Health Corp is shutting down its clinical trials division, which launched in 2021, and will conclude operations in 2024. The division has worked with more than 30 drugmakers on 50 Phase I, II and IV studies involving 33,000 participants, according to Modern Healthcare.

As CMS continues to tighten oversight of misleading marketing activities, the agency will soon require Medicare Advantage organizations to file all materials that mention any type of benefit. In a May 10 memo from the Medicare Drug & Health Plan Contract Administration Group, CMS explained that while it previously interpreted the mentioning of widely available benefits (e.g., vision, dental, premium reductions) as “general descriptions” that were not “made with sufficient intent to draw attention to a particular plan or subset of plans” and lead to an enrollment decision “without information on the associated costs for enrollees,” complaints received through various channels have indicated otherwise. Therefore, CMS is expanding its interpretation of “marketing” to “include content that mentions any type of benefit covered by the plan and is intended to draw a beneficiary’s attention to plan or plans, influence a beneficiary’s decision-making process when selecting a plan, or influence a beneficiary’s decision to stay enrolled in a plan (that is, retention-based marketing) and thus subject to review.” As such, the agency will require any material or activity that is distributed by any means and mentions any benefit to be submitted into the Health Plan Management System effective July 10.