Real-world evidence (RWE) is all the rage in med-tech circles, given the promised efficiencies, but the U.K. National Institute for Health and Care Excellence is especially dialed in on RWE. The agency recently announced that it will expand its use of RWE to include health technology assessments (HTAs), promising a slightly less drag-filled path to clinical adoption in one of the world’s most robust markets.
The U.S. CMS has posted a second draft rule that would streamline prior authorizations by Medicare Advantage insurers, a move sure to draw support from patients and clinicians alike. This would be achieved by requiring that payers adopt the Health Level 7 interoperability standard, a requirement that may take every bit of the three years to achieve before a final rule would go into effect under the terms of the proposed rule.
The U.S. Office of Inspector General examined the volume of tests for allergies and respiratory pathogens conducted during the COVID-19 pandemic, and found a few outlier testing labs that billed a conspicuous volume of such tests. While the agency recommended that the CMS examine these claims more closely, the results also suggest that enforcement action may be en route for the more than 160 labs identified as having filed a higher than typical volume of claims for these tests.
The U.S. CMS had the usual mix of good news and bad news in its hospital outpatient final rule for calendar year 2023, which served up a plate of bad news for Brainscope Inc. and Elucent Medical Inc., which will enjoy no new technology pass-through (NTPT) payments in the coming year for their applications. Conversely, Carlsmed Inc. and Microtransponder Inc. both came out of the annual NTPT scrum with wins, thus ensuring they’ll be able to more rapidly recapture their med tech investments.
The U.S. CMS has finalized the physician fee rule for calendar year 2023, a document that imposes an across-the-board pay cut of approximately 4.5% for physician Medicare services. However, the American College of Cardiology (ACC) and the Heart Rhythm Society (HRS) blasted the final rule’s failure to provide what they believe are appropriate rates for cardiac ablation services, a position backed by two med-tech trade associations in their comments to the docket for the draft rule.
The U.S. CMS has peeled back a proposed 4.2% rate cut in the home health payment draft rule for calendar year 2023, replacing it instead with a 0.7% increase in overall payments for home health services, a category that affects sales of durable medical equipment and home infusion therapy items. That change was insufficient to mollify the National Association for Home Care & Hospice (NAHC), which argued that the final rule will nonetheless severely hit home care providers and leaves NAHC with no choice but to take its concerns to Capitol Hill.
Medicare coverage of breakthrough medical devices is in its fourth iteration under the rubric of Transitional Coverage of Emerging Technologies (TCET) and two managers at the Centers for Medicare & Medicaid Services recently penned an op-ed in a leading medical journal about the TCET program, which generated at least as many questions as answers.
The Verifying Accurate Leading-edge IVCT Development (VALID) Act has been floating around Capitol Hill for the past four years, but was once again left by the wayside when Congress passed the latest round of U.S. FDA user fee legislation. Scott Whitaker, president and CEO of the Advanced Medical Technology Association, said in a press briefing that the prospects for the legislation dim considerably if Congress does not pass the VALID Act by the end of the calendar year, raising the prospect that the FDA will act unilaterally to engage in rulemaking to deal with regulation of lab-developed tests.
The question of Medicare coverage for breakthrough devices is still in play at CMS, but managers there penned an Oct. 12 editorial that suggests that existing coverage mechanisms may have to suffice. CMS’s Lee Fleisher and Jonathan Blum said in the JAMA Internal Medicine (JAMA: IM) editorial that the agency might respond to the breakthrough device coverage question by applying the coverage with evidence development (CED) mechanism for breakthrough devices, suggesting that the policy might ultimately resemble the coverage mechanisms already available to industry.
The Medicare coverage with evidence development (CED) program has served a vital function for coverage of medical technology for a number of years, but staff at CMS apparently see room for improvement.
