BioWorld - Monday, December 22, 2025

Articles Tagged with ''Advamed''

U.S. flag, stethoscope

CMS puts final nail in the MCIT coffin

Nov. 15, 2021
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services (CMS) finally laid to rest the rule for Medicare Coverage of Innovative Technology (MCIT), a policy proposal that found favor with industry and with several patient groups. However, the news comes shortly after a bipartisan group of 10 senators had penned a letter to the agency to reissue the rule, reinforcing the prospect that the MCIT proposal will find widespread support in the halls of Congress in 2022.
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U.S. flag, stethoscope

Stakeholders jeer Medicare physician fee final for 2022, but telehealth scores a win

Nov. 3, 2021
By Mark McCarty
The U.S. CMS waded into controversy with two final rules calendar year 2022, drawing fire from device makers and doctors who allege that cuts in rates for physicians will hamper beneficiary access. Software developers working in the telehealth space will find much to cheer, however, given that some telehealth services that were covered during the COVID-19 pandemic will be covered after the pandemic has passed.
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European Union flag

European Commission proposes additional year for IVDR implementation

Oct. 14, 2021
By Mark McCarty
The shortage of European notified bodies (NBs) for in vitro diagnostics has prompted calls from industry to delay the compliance dates for the In Vitro Diagnostic Regulation (IVDR), and the European Commission has responded with a proposed fix. The Commission proposed to give IVDs that are already on the market until May 2025 or later to obtain new CE marks, but the change requires the assent of the European Parliament and the European Council before it goes into force.
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U.S. FDA headquarters

FDA retains pre-inspection features in final rule for de novo petitions

Oct. 5, 2021
By Mark McCarty
The FDA’s final rule for the de novo petition process took nearly three years to wrap up, a timeline likely extended by the COVID-19 pandemic, but the final rule retains some controversial features seen in the 2018 draft. Among these is a provision for FDA inspections before determining whether to grant the petition, a provision that was blasted by multiple commenters as extra-statutory and a needless source of drag on these applications.
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Health, medical icons
2021 Medtech Conference

Existing authorities are adequate for breakthrough device coverage in U.S.

Sep. 28, 2021
By Mark McCarty
The demise of the Medicare Coverage of Innovative Technologies (MCIT) rule may not be the end of the breakthrough devices coverage story, but Lee Fleisher of the U.S. Centers for Medicare & Medicaid Services (CMS) said the MCIT rule was riddled with deficiencies. Fleisher said CMS is of the view that expedited coverage of breakthrough medical devices would be better handled under existing statutory authorities, suggesting the agency sees no need for the MCIT-driven provisions of the Cures 2.0 legislation.
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Lab research with pipette, microsope
2021 Medtech Conference

Stakeholders anxious for passage of VALID Act to reform FDA regulation of LDTs

Sep. 27, 2021
By Mark McCarty
The issue of FDA regulation of lab-developed tests (LDTs) has been percolating for a number of years, but the Verifying Leading-edge IVCT development (VALID) Act of 2021 appears to offer the solution. Several stakeholders, including Jeff Allen, president and CEO of Friends of Cancer Research, are eager to see the reforms come through quickly, given the increasingly vital role that tests such as companion diagnostics play in the care of patients facing potentially deadly diseases.
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U.S. flag, stethoscope

AdvaMed’s Whitaker: MCIT not a subversion of Medicare review, but open to alternatives

Sep. 23, 2021
By Mark McCarty

The Medicare Coverage of Innovative Technology (MCIT) rule is administratively a dead letter, but the U.S. House of Representatives’ Cures 2.0 legislation would statutorily resurrect the MCIT concept. Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed), said automatic coverage of breakthrough devices does not constitute a subversion of the Medicare coverage process, but added that AdvaMed is not opposed to other means of cutting the Medicare red tape, such as greater resources at CMS.


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