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Home » Topics » Regulatory » Medicare

Medicare
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Industry not placated by changes to US negotiations guidance

June 26, 2023
By Mari Serebrov
In releasing a revised guidance June 30 detailing the requirements of the new Medicare Drug Price Negotiation Program, the U.S. Centers for Medicare & Medicaid Services addressed some of the issues raised in recent constitutional challenges to the guidance and the underlying negotiation provision in the Inflation Reduction Act.
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Senior eye exam

Medicare administrative contractors take dim view of several glaucoma technologies

June 12, 2023
By Mark McCarty
Beneficiaries in the U.S. Medicare program have access to several technologies and procedures for treatment of glaucoma, but Medicare administrative contractors (MACs) seem to be looking sideways at some of these offerings. Both Wisconsin Physician Services and Palmetto GBA have floated draft local coverage proposals that deem procedures such as goniotomy and the combination of canaloplasty and trabeculectomy to be investigational, suggesting that claims for these and other services and devices will not be paid by these MACs.
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Fraud blocks under magnifying glass

US surgeon agrees to pay $43M for unperformed vascular procedures

May 30, 2023
By Mark McCarty
Most enforcement activities in the U.S. related to physician participation in fraud deal with activities that run to six figures at most, but the U.S. Department of Justice (DOJ) reported recently that it has snared a much bigger fish.
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Leqembi

Pressure mounts for CMS coverage ahead of Leqembi’s ‘full’ approval date

May 22, 2023
By Mari Serebrov
As the clock ticks toward the “full,” or traditional, approval date for Biogen Inc./Eisai Co. Inc.’s Alzheimer’s drug, Leqembi (lecanemab), the U.S. Centers for Medicare & Medicaid Services (CMS) is facing increasing pressure to get the structures in place to ensure Medicare beneficiaries have access to the drug when the approval comes.
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No political divide in frustration over CMS Alzheimer’s coverage

April 26, 2023
By Mari Serebrov
U.S. Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure made her first appearance April 26 before the House Energy and Commerce’s Subcommittee on Health, ostensibly to discuss legislative solutions to increase transparency and competition in health care. But member after member, regardless of political party, demanded answers about why CMS continues to severely restrict access to Eisai Co. Ltd.’s Alzheimer’s drug, Leqembi (lecanemab), especially since another government agency is covering it for all veterans that meet the labeling requirements.
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US CMS’ Part B inflation rebate list gets a shave

April 4, 2023
By Mari Serebrov
The U.S. Centers for Medicare & Medicaid Services (CMS) has scaled back the list of Medicare Part B drugs facing the new inflation rebate under the Inflation Reduction Act for the first quarter of 2023.
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Prescription drug bottles and pills

US RX pricing controls begin to kick in

March 15, 2023
By Mari Serebrov
Despite the new Medicare inflation rebate, the U.S. price of 27 Part B drugs grew faster than inflation in the last quarter of 2022, triggering the new rebate provision in the Inflation Reduction Act. The manufacturers of those single-source drugs will be billed for the rebates in 2025, but Medicare beneficiaries should see a drop in their coinsurance for those drugs, for the next quarter at least.  According to the Biden administration, the decrease in out-of-pocket costs for those drugs will range from $2 to as much as $390 per average dose from April 1 through June 30.
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Leqembi that, CMS

March 14, 2023
By Mari Serebrov
The U.S. Veterans Health Administration (VA) is being applauded for doing what Medicare has refused to do – provide coverage for Leqembi (lecanemab) in the early stages of Alzheimer’s disease. Under the March 13 VA decision, the Eisai Co. Ltd. drug, which was partnered with Biogen Inc. and granted accelerated approval in January, will be listed as a nonformulary therapy that must be prescribed by a VA-board certified neurologist, geriatric psychiatrist or geriatrician who specializes in treating dementia.
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US budget preview puts more Medicare burden on biopharma

March 7, 2023
By Mari Serebrov
The Biden administration offered a sneak peek March 7 at its fiscal 2024 budget by outlining ways it proposes extending the life of the U.S. Medicare Hospital Insurance Trust Fund by at least 25 years.
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U.S. flag, stethoscope

Prior authorization reform needed now, US CMS told

Feb. 15, 2023
By Mari Serebrov
In decrying high U.S. drug prices, lawmakers often cite statistics about the number of patients who forgo or ration their prescriptions because of the out-of-pocket cost. Those discussions overlook the role payer utilization management tactics, including prior authorization, may play in patients abandoning their treatment, be it a specific drug or an imaging service.
Read More
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