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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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Medicare puzzle

Physicians slam US Medicare doc fee schedule for rate cuts

July 11, 2024
By Mark McCarty
The U.S. Medicare physician fee schedule for 2025 appears set to reduce the number of services that can be provided via telehealth, but the proposed rate cut of 2.8% for physician services triggered a backlash from specialty medical societies, which seem destined to lobby Capitol Hill for a reversal of these cuts.
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CMS logo and website

US CMS dubious of pass-through standing of Boston Sci’s Agent

July 10, 2024
By Mark McCarty
The draft version of the U.S. Medicare hospital outpatient rule for 2025 carries more than a dozen applications for a new technology pass-through payment next year, but Boston Scientific Corp.’s Agent balloon for treatment of in-stent restenosis might not be eligible for NTPT payment because of a debate over whether the device can be assigned to an existing Healthcare Common Procedure Coding System code.
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