FDA’s approval of Alzheimer drug triggers broader Medicare coverage, higher Medicare spending
The Centers for Medicare & Medicaid Services (CMS) announced on Thursday that broader Medicare coverage is now available for Biogen and Eisai’s Leqembi (the brand name for lecanemab) following the Food and Drug Administration’s (FDA) traditional approval of the drug that treats individuals with Alzheimer’s disease. But it will come at an inflated cost for Medicare.
Medicare coverage is available to Medicare enrollees who are diagnosed with mild cognitive impairment or mild Alzheimer’s disease dementia, with documented evidence of beta-amyloid plaque on the brain and have a physician who participates in a qualifying registry with an appropriate clinical team and follow-up care. Clinicians who participate in the registry must complete a short, easy-to-use data submission.
The drug will likely lead to higher Medicare spending, considering Leqembi’s annual price of $26,500 and expected demand for it among patients with Alzheimer’s disease, noted KFF. Based on estimates that 100,000 individuals will take the drug by year three, KFF said annual Medicare spending would be $2.7 billion, which would make it the third most costly drug covered by Medicare Part B, based on 2021 total spending. But these estimates might be conservative. If 10 percent of Medicare Part B enrollees with Alzheimer’s take the drug, the annual spending would rise to $17.8 billion.
NAHC sues Medicare over payment cuts to home care and hospice
The National Association for Home Care and Hospice (NAHC) has filed a lawsuit in U.S. District Court for the District of Columbia against CMS and the Department of Health and Human Services (HHS) challenging the validity of a change in Medicare home health payment that reduced rates by 3.925 percent in 2023 with significant additional cuts expected over the next several years. CMS has proposed an additional 5.653 percent permanent rate cut to begin in 2024 based on the same challenged payment methodology.
The lawsuit argues that Medicare is required to institute the payment model changes in a budget neutral manner rather than to inflict rate cuts that have precipitated services limitations or access to care. Until recently, nearly 3.5 million Medicare beneficiaries received home health services annually. Since the new payment model began in 2020, over 500,000 fewer Medicare patients have accessed home health services.
The lawsuit seeks declaratory and injunctive relief including a reversal of the rate adjustments in the 2023 rule and requirement that Medicare implement the budget neutrality mandate consistent with the law.
“Home health agencies again must withstand billions of dollars in payment cuts as cost of care continues to rise and still be expected to deliver the care to which our patients are entitled to as a Medicare benefit,” said Ken Albert, chairman of NAHC, and CEO of Androscoggin Home HealthCare + Hospice, in a statement. “Since these cuts took effect in January, providers have reduced service areas, turned away thousands of patients, and halted the use of innovative technologies in order to stay afloat and serve some patients.”
KFF: 1.6M have lost Medicaid coverage since April 1
As of July 5, KFF’s Medicaid enrollment and unwinding tracker finds that 28 states and the District of Columbia have reported disenrolling more than 1.6 million Medicaid recipients since the unwinding of the Medicaid continuous enrollment provision began in April. Because not all states have publicly available data on total disenrollments, KFF said the data reported in the tracker may undercount the actual number of disenrollments.
The Medicaid continuous enrollment provision stopped Medicaid disenrollments during the COVID pandemic. Enrollment in Medicaid and CHIP grew to nearly 95 million during that period. The provision ended on March 31, and states can unwind the continuous enrollment provision over the following 12 months and redetermine eligibility for all Medicaid enrollees. Millions of people are expected to lose Medicaid coverage as a result.
Health Connect America to pay $4.6M for improper billing practices
The Justice Department announced that Health Connect America (HCA), which is headquartered in Franklin, Tenn., has agreed to pay $4.6 million to resolve allegations that it billed Virginia Medicaid for services not provided. As part of the settlement, the organization will be subject to five years of increased compliance and oversight.
The allegations involved HCA billing Medicaid improperly for three separate behavioral health services available to children who qualify. Therapeutic Day Treatment is a school-based program designed to assist children with various mental health diagnoses who need support during the school day. HCA billed Virginia Medicaid for providing services to students who were absent from school, and when school was not open due to holiday or weather closures.
“Ensuring that healthcare providers accurately bill programs such as Medicaid and Medicare are one of the cornerstone functions of law enforcement,” United States Attorney Christopher R. Kavanaugh said in the announcement. “When providers fail in that mission, we must hold them accountable. I am grateful to all those who worked on this matter and brought it to a just conclusion.”
The agreement resolves HCA’s potential criminal liability based on the investigation. As part of the resolution, HCA has committed to various compliance measures, including, but not limited to, increased compliance and audit requirements, unannounced audits, and enhanced reporting requirements if and when there are incidents of theft, fraud, abuse, or neglect.