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Home » Topics » Regulatory » CMS

CMS
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Drug capsule and dollar sign

Negotiated Rx prices deserving of the fanfare?

Aug. 15, 2024
By Mari Serebrov
“For us geeks, this is the trailer. This isn’t the movie,” John Stanford told BioWorld as he reacted to the prices the U.S. Centers for Medicare & Medicaid Services announced Aug. 15 for the 10 drugs selected for the first round of negotiations under the Inflation Reduction Act. While the prices are generally in line with what was expected, Stanford said they raise more questions than answers. The rationale for those prices, which must be released by March 1, will be part 1 of the movie as it should provide some insight into the price setting, said Stanford, the executive director of Incubate, a coalition of investors in the early stage life sciences sector.
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Medicare puzzle

Medicare inpatient final rule adds DRG for ablation, LAA closure

Aug. 15, 2024
By Mark McCarty
Device makers and physicians alike were less than enthused about several features of the draft Medicare inpatient rule for fiscal year 2025, but thanks in part to support from the device industry, the final rule provides a new code that encompasses both left atrial appendage closure and ablation, a change that may reduce spending without dinging sales of these devices.
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Medicare puzzle

US Medicare’s TCET final fuzzy on definition of ‘similar device’

Aug. 8, 2024
By Mark McCarty
The U.S. CMS announced the release of the Transitional Coverage for Emerging Technologies policy, which is less than clear on the definition of a key term.
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Eye with digital overlay

Abbott, Edwards, Medtronic all score in US Medicare inpatient final

Aug. 5, 2024
By Mark McCarty
The U.S. Medicare program’s final rule for fiscal year 2025 inpatient care retains several controversial proposals, but some device makers fared well in their new technology add-on payment (NTAP) applications, including Dublin-based Medtronic plc, which won NTAP payments for two devices.
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US HHS scores another IRA win

Aug. 5, 2024
By Mari Serebrov
The U.S. Department of Health and Human Services (HHS) is 6-1 so far in blocking court challenges to the Medicare price negotiation program mandated by the Inflation Reduction Act (IRA). The department’s latest victory came July 31 when a federal district judge in New Jersey tossed a complaint filed by Novo Nordisk A/S, citing a lack of jurisdiction on the court’s part and the company’s lack of standing.
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Medicare puzzle

Industry supportive of new DRG code for combination of procedures

July 30, 2024
By Mark McCarty
The U.S. CMS proposed a series of changes to the Medicare series of codes for diagnostic-related groups, and device makers had pointed remarks about some of those proposals.
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US Medicare’s CED process draws fire for lack of predictability

July 18, 2024
By Mark McCarty
The coverage with evidence development (CED) process employed by the U.S. Medicare program may suffer from underutilization, but the authors of a new article in Value in Health see the attendant problems as administrative in nature. The issues include, but are not limited to, a lack of predictability as to when a CED study would be required for coverage of a medical device.
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U.S. flag, stethoscope

Vertex: US government is the barrier to necessary medical care

July 16, 2024
By Mari Serebrov
In denying Medicaid patients with sickle cell disease or transfusion-dependent beta-thalassemia access to Vertex Pharmaceuticals Inc.’s fertility preservation program, which is intended to counteract a side effect of the company’s gene-editing therapy, Casgevy, “the federal government now stands as the barrier between thousands of predominantly Black Americans and the necessary medical care that would protect their basic right to have biological children,” Vertex said in a lawsuit filed July 15.
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US Medicare program offers pay boost for radiopharmaceuticals

July 15, 2024
By Mark McCarty
The U.S. Medicare outpatient draft for 2025 is rich with applications for pass-through payment, but the draft also would boost payment for radiopharmaceuticals, a proposal that drew the applause of industry and physicians alike. The outpatient draft for CY 2025 tackles the implications of some new technologies for the pass-through payment program, but nestled in the draft rule is a proposal to pay separately for diagnostic radiopharmaceuticals.
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U.S. flag, stethoscope

US Medicare program offers pay boost for radiopharmaceuticals

July 12, 2024
By Mark McCarty
The U.S. Medicare outpatient draft for 2025 is rich with applications for pass-through payment, but the draft also would boost payment for radiopharmaceuticals, a proposal that drew the applause of industry and physicians alike.
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