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Home » Topics » Regulatory » Medicare

Medicare
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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.
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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

CMS fixes needed to implement new US Part B inflation rebate

Feb. 8, 2023
By Mari Serebrov
While the new inflation-based rebate on certain Part B drugs may generate billions of dollars in savings for Medicare, implementing the rebate could be more challenging than the U.S. Congress and the Biden administration expected when the Inflation Reduction Act was enacted last August.
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Money and pills

BIO CEO 2023: Mitigating the impacts of the US Inflation Reduction Act

Feb. 7, 2023
By Karen Carey
With the passage of the Inflation Reduction Act in the U.S. in August 2022, biopharma company leaders have re-evaluated pipelines, sought legal advice, and discussed ways to mitigate the potential impacts the legislation will have on pricing therapies and extending their reach to new indications.
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First rounds of US price negotiations to center on Price D drugs

Jan. 12, 2023
By Mari Serebrov
Although the U.S. Inflation Reduction Act charges the Centers for Medicare & Medicaid Services with negotiating prices of the Part B and D drugs with the highest Medicare spend, the first two rounds of negotiations will focus solely on Part D drugs, which are dispensed through pharmacies.
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Inflation Reduction Act first major US victory on Rx prices, but likely not the last

Dec. 27, 2022
By Mari Serebrov
Topping biopharma regulatory news in 2022 was the signing of the Inflation Reduction Act (IRA), as its provisions requiring Medicare to directly negotiate certain prescription drug prices will open the door for the first time to a degree of government price controls in the U.S., affecting the bottom line of drug companies around the world.
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Inflation rebate not the only new Medicare payment

Nov. 10, 2022
By Mari Serebrov
In addition to the Medicare inflation rebate and the other pricing reforms of the Inflation Reduction Act, manufacturers of certain Part B drugs will be subject to a refund provision tucked away in the Infrastructure Investment and Jobs Act that was signed into U.S. law last year.
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US Medicare beneficiaries to get small relief in Part B premiums

Sep. 28, 2022
By Mari Serebrov
The U.S. Centers for Medicare & Medicaid Services is finally making a long-expected, and requested, adjustment to Medicare Part B premiums, which were raised nearly 15% for 2022 in the wake of Biogen Inc.’s initial $56,000 annual price tag for its Alzheimer’s drug, Aduhelm (aducanumab).
Read More
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