Medicare officials announced plans to broadly cover a new class of Alzheimer’s drugs following an intense lobbying campaign by patient advocates and drugmakers pressing for access to the first medications shown to slow cognitive decline from the disease.
in previous agency statements — for anyone who was enrolled in the outpatient part of the program who meets the criteria for coverage. The first drug potentially covered by the expanded plan could be granted full approval from the Food and Drug Administration as soon as this summer, a necessary step before Medicare will start paying.
The decision by CMS is the latest development in a high-stakes struggle over how to handle the emergence of disease-modifying therapies that studies show provide some benefit. Critics of the drugs say they are not highly effective, pose serious safety risks, including bleeding in the brain, andAlzheimer’s advocates counter that the drugs are the first glimmer of hope in treating a disease that robs patients of their memories and identities andand their finances. About 6.
Outside FDA experts — the agency’s Peripheral and Central Nervous System Advisory Committee — are expected to meet June 9 to discuss Leqembi, which receivedfrom the agency in January. The FDA’s deadline for deciding on full approval is July 6. Advocates for the drugs are sure to welcome a Medicare policy that does not link coverage to participation in clinical trials. But, depending on the details, some may feel that registries are still too burdensome and could curtail access. Registries can be time-consuming for some medical practices, especially in rural and underserved communities, they have previously said.
The CMS statement said the broader coverage would begin on the day the FDA grants Leqembi traditional approval and would apply to other drugs in the class that receive similar approval in the future. The statement also said that physicians and their staffs would be able to submit data on the drugs through a CMS-facilitated portal and that several private organizations are preparing to open their own registries.
Canada Latest News, Canada Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Richmond man sentenced for $1.4 million Medicare home health fraud schemeThe home health company owner allegedly billed Medicare for services not medically necessary or provided for several years. He's set to spend nearly five years behind bars.
Read more »
Arizona Opinion: Congress must protect Social Security and Medicare'If the United States defaults on its debts, its credit rating would plummet, and borrowing costs would skyrocket.'
Read more »
Richmond man sentenced to nearly 5 years in Medicare home health fraud scheme, agrees to pay back $1.4M in restitutionA 47-year-old home health company owner has been sentenced to nearly five years in prison for a $1.4 million Medicare home health fraud scheme, the United States Department of Justice announced Tuesday.
Read more »
Internists: Increased earnings can't stop rising discontent'Decreasing Medicare reimbursement and poor payor mix destroy our income,' one physician wrote, and another said that 'patients have become rude and come with poor information from social media.'
Read more »
McCarthy says a bit too much about the point of his new ‘commission’Why is Kevin McCarthy pitching another fiscal 'commission'? As stevebenen writes, it's all about the Republican goal of targeting Social Security and Medicare.
Read more »
Beyoncé Shows Her Love for Tina Turner With ‘River Deep-Mountain High’ Cover“I want you guys to help me sing one of my favorite songs,” she told the crowd.
Read more »