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Home » Topics » Regulatory » CMS

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Congress poised to revisit site-neutral payment

Nov. 5, 2024
By Mark McCarty
While the inpatient and outpatient final rules for 2025 are baked into the U.S. Medicare payment system, there are indications that Congress will consider legislation that would flatten rates across sites of service.
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CMS logo and website

CMS opts for separate pass-through categories for renal denervation

Nov. 4, 2024
By Mark McCarty
The U.S. Medicare outpatient final rule affirms several new devices for the new technology pass-through program, but one of the more significant findings is that CMS will use separate payment mechanisms for two renal nerve denervation devices, following the blueprint the agency employed for this question in the inpatient final rule.
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Gold dollar sign and gray question marks

Uncertainties plague short-term ‘win’ of US price negotiations

Oct. 25, 2024
By Mari Serebrov
If the maximum fair prices the U.S. CMS announced after the first round of drug price negotiations are any indication, advocates of the government price setting may be settling for short-term wins at the cost of long-term, more sustainable price reductions driven by competition.
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Edwards EVOQUE

Edwards wins support for TTVR device Medicare coverage proposal

Oct. 7, 2024
By Mark McCarty
Edwards Lifesciences Corp. made a splash recently with the U.S. FDA approval of the Evoque tricuspid valve replacement device, but is also pressing Centers for Medicare and Medicaid Services to provide a coverage framework for this class of devices.
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US CMS sets playing field for next round of Rx price negotiations

Oct. 3, 2024
By Mari Serebrov
Round 2 of the U.S. Medicare price negotiations officially began late Oct. 2 with CMS’ release of its final playbook and timeline, which build on lessons learned from the first round and comments on a draft negotiations guidance that was published in May. In response to the feedback CMS received, the second round will allow for more patient-focused sessions and offer increased engagement with the makers of the drugs selected for negotiations.
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Ozempic and Wegovy pens and packaging

Should generics jump the queue in Wegovy parade?

Sep. 25, 2024
By Mari Serebrov
Given the demand for Ozempic and Wegovy and the revenue the GLP-1 drugs are generating for Novo Nordisk A/S in the U.S., a lot of generic companies are clamoring to cash in on the drugs’ current popularity. And there are some U.S. lawmakers more than willing to oblige.
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Pills, bottle atop $100 bill

PhRMA challenge to US price negotiations lives again

Sep. 23, 2024
By Mari Serebrov
The U.S. Court of Appeals for the Fifth Circuit revived the Pharmaceutical Research and Manufacturers of America’s (PhRMA) constitutional challenge to the Medicare price negotiations, sending it back to a federal court in Texas for a do-over.
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Lab chip skin wound healing with electricity

Industry wary of CMS’s view of skin substitutes in doc fee draft

Sep. 20, 2024
By Mark McCarty
The draft Medicare physician fee schedule for calendar year 2025 provoked a strong backlash from physician societies due to a net cut in physician pay. Device makers have their own concerns, including the latest in a series of controversies over coverage of skin substitutes.
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Gears with regulatory words

MDMA urges CMS to craft separate outpatient payments for RDN devices

Sep. 19, 2024
By Mark McCarty
The U.S. CMS believes it has a quandary on its hands with regard to transitional pass-through payment for renal denervation devices, but the Medical Device Manufacturers Association urged the agency to provide separate payment mechanisms for these devices as seen in the inpatient final rule.
Read More
Cloud/cybersecurity illustration

CMS acknowledges 2023 cybersecurity hack of Medicare contractor

Sep. 9, 2024
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services posted a Sept. 6 statement regarding a cyber incident involving nearly 950,000 patient records held by a Medicare administrative contractor.
Read More
Previous 1 2 3 4 5 6 7 8 9 10 … 32 33 Next

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