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Home » Topics » Regulatory » CMS

CMS
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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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U.S. flag and money

Biden administration’s budget proposal for FY 2024 takes a hit on the Hill

March 28, 2023
By Mark McCarty
The Biden administration’s budget proposal for the U.S. federal government’s 2024 fiscal year is undergoing the usual vetting in Congress, and one hearing each in the House and Senate suggest the proposal will gain little or no traction on Capitol Hill. However, supporters of the National Institutes of Health (NIH) may be cheered by the fact that one of President Biden’s own party, Rep. Rosa DeLauro (D-Conn.), blasted the proposal for offering only a 2% increase in the NIH budget, a sign that the agency will receive a substantial boost in monies yet again in FY 2024.
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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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Dexcom G7 (left) and Freestyle Libre 3 (right)

CMS surprises with earlier and broader CGM coverage, good news for Abbott and Dexcom

March 3, 2023
By Annette Boyle
Three months earlier than anticipated, CMS published its final local coverage determination (LCD) for continuous glucose monitors and included more people with diabetes than expected. The new policy expands coverage from individuals with type 1 diabetes or type 2 diabetes using multiple daily injections of insulin to anyone treated with insulin, essentially doubling the market for manufacturers of continuous glucose monitors (CGMs).
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US CMS eyes coverage for power 3 wheelchair seat elevation systems

Feb. 23, 2023
By Mark McCarty
The U.S. CMS has unveiled a proposed national coverage determination for powered seat elevation systems for Group 3 power wheelchairs, one of the more expensive items in the category of mobility durable medical equipment (DME). However, the agency indicated that it will soon examine coverage of powered seat elevation systems for Group 2 power wheelchairs, the combination of which suggests that manufacturers in the DME space are looking at a market that seems poised to explode.
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US CMS refuses to budge on coverage of Alzheimer’s drugs

Feb. 23, 2023
By Mari Serebrov
Despite pleas from patient advocacy groups and bipartisan pressure from the U.S. Congress, the Centers for Medicare & Medicaid Services (CMS) isn’t budging on its national coverage determination for amyloid-targeting monoclonal antibodies approved to treat Alzheimer’s.
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Prescription drug bottle, pills shaped in $ sign

US CMS urged to reconsider Alzheimer’s drug coverage

Feb. 21, 2023
By Mari Serebrov
Now that the U.S. FDA has granted accelerated approval for Biogen Inc./Eisai Co. Ltd.’s early Alzheimer’s drug, Leqembi (lecanemab), the Centers for Medicare & Medicaid Services (CMS) is being pressured to rethink its coverage of amyloid-targeting monoclonal antibodies.
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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.
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New US CMS drug payment model seen as ‘attack on accelerated approval’

Feb. 15, 2023
By Mari Serebrov
A trio of proposed Medicare drug payment models that made a Feb. 14 debut in the U.S. is playing to mixed reviews. Two of the models to be tested by the U.S. Centers for Medicare & Medicaid Services (CMS) Innovation Center seem to “address the real problems underlying prescription drug pricing – patient out-of-pocket expenses and better payment systems that reward the value a medicine brings to the patient and the overall health care system,” said John Murphy, chief policy officer for the Biotechnology Innovation Organization. But he called the third model, which is expected to restrict Medicare payment for some Part B drugs that have indications with accelerated approval, “an attack on the accelerated approval pathway,” which Congress mandated to spur investment and innovation in areas of unmet medical need.
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Prior authorization reform needed now, US CMS told

Feb. 14, 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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