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Home » Authors » Mark McCarty

Mark McCarty

Articles

ARTICLES

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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Product recall concept image

Medtronic withdraws endotracheal tubes after 2 years

July 10, 2024
By Mark McCarty
In an action two years in the making, Dublin-based Medtronic plc withdrew a series of endotracheal tubes because of complaints of lost functionality that carries the risk of respiratory and/or cardiac arrest.
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CMS logo and website

US CMS eyes coverage of home dialysis for acute kidney injury

July 9, 2024
By Mark McCarty
The U.S. Medicare draft prospective payment system for end-stage renal disease encodes a few changes that will cheer industry, including a provision that would increase patient access to pharmaceuticals that are available only in oral form.
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Document illustration

FDA warning to wound care company raises product status question

July 9, 2024
By Mark McCarty
The U.S. FDA warning letter to AG Essence Inc., a maker of wound care products, raised the question of whether the the company’s Banda product line is a drug or a device, although the FDA’s device center was the issuer of the warning letter. However, the company told ioWorld that it sees its offerings as homeopathic products rather than as drugs or devices, suggesting that this product jurisdiction scrum is far from over.
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Digital handshake

US FDA’s new misinformation draft guidance revisits 2014 version

July 8, 2024
By Mark McCarty
Bob Califf, commissioner of the U.S. FDA, has been laser-focused on misinformation recently, and the agency reissued a 2014 draft guidance that describes an enforcement policy about third-party communications about a drug or device. The draft appears to sidestep at least one major problem with the 2014 edition, but seems to suggest that manufacturers should consider addressing misinformation about an entire class of products.
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Map of Australia as blue circuit board, digital network

Australia’s new requirements for devices come into play

July 8, 2024
By Mark McCarty
Australia’s Therapeutic Goods Administration (TGA) made significant changes to some of its regulations, including those for software-based medical devices. The TGA said that entities that are switching their products to a higher risk classification can continue to offer them for six months after Nov. 1, 2024, if they have an application on file with the TGA, but only if the sponsor notified the agency of such intent prior to May 25, 2022.
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Laptop displaying FDA logo

Industry afforded more chances to tap into FDA’s TAP

July 5, 2024
By Mark McCarty
The pilot version of the U.S. FDA’s advisory program for breakthrough medical device life cycle management was initially limited to cardiovascular devices, but the agency has announced an expansion into other product areas. Going forward, orthopedic, radiological and ophthalmic devices will be eligible for the FDA’s Total Life Cycle Advisory Program, which will aid applicants in obtaining both faster and more trouble-free market access.
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CMS logo and website

MedPAC wary of Medicare software payment in fee-for-service care

July 3, 2024
By Mark McCarty
The problems with U.S. Medicare coverage for medical software are well known, but the Medicare Payment Advisory Commission recently indicated that these problems are largely manageable for services delivered via managed care plans.
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View All Articles by Mark McCarty

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