Developers of blood tests for the early diagnosis of Alzheimer’s disease (AD) are poised to see a spike in demand, following the FDA’s accelerated approval on Tuesday of Cambridge, Mass.-based Biogen Inc.’s AD drug treatment Aduhelm (aducanumab). The FDA’s decision paves the way for AD assays to move beyond aiding in drug development toward addressing ongoing issues with undiagnosed cases.
The decision by the U.S. Centers for Medicare & Medicaid Services (CMS) to suspend the Medicare Coverage of Innovative Technology (MCIT) rule a second time was controversial, but CMS’s Tamara Syrek Jensen vowed that the agency has made no final decision. Jensen acknowledged that the agency has not foreclosed a full-blown rescission of the MCIT proposal, a not-implausible outcome given the prospect that legislation in the works in the House Energy and Commerce Committee could render the rule moot.
Early feasibility studies for cardiology devices were a massive problem for the FDA and industry in times gone by, a problem that was believed to drive device flight from the U.S. That problem has been largely solved, according to the FDA’s Andrew Farb, but Farb noted that neurological devices are the next target for improved early feasibility study (EFS) development in the U.S., which suggests that the path to pivotal studies for devices in this space will soon be much less cumbersome.
With a number of Medicare coverage policies in flux, the U.S. Senate has confirmed Chiquita Brooks-LaSure as the next CMS administrator, closing out one more critical remaining position for the Biden administration at the Department of Health and Human Services. Still unannounced is the administration’s nominee to lead the FDA, an omission that becomes more conspicuous with each passing day.
The U.S. Preventive Services Task Force (USPSTF) has updated its recommendations for lung cancer screening, which expands the age group for screening to include those aged 50-54 years. The change has forced CMS to reopen the national coverage memo for low-dose CT screening for lung cancer, which appears to be set to add millions to the number of Americans who are eligible for annual screening procedures.
Despite support from a wide range of stakeholders and bipartisan congressional support, the U.S. CMS has suspended implementation of the Medicare Coverage of Innovative Technology (MCIT) rule through Dec. 15, 2021. CMS argued that most of the approved or cleared breakthrough devices are already covered through existing payment mechanisms, but the delay opens the door to any one of multiple possible legislative solution, such as follow-on legislation to the 21st Century Cures Act.
The latest report by the Medicare Payment Advisory Commission (MedPAC) includes an advisory about unfettered expansion of telehealth, but the commission also said that expanded access to ambulatory surgical centers could trim per-procedure spending, which in some instances is about half the fee paid for a given procedure when performed in a hospital outpatient department (HOPD).
CMS has posted the draft Medicare inpatient rule for fiscal year 2022, replete with the usual controversies over reassignment of procedures under the Medicare diagnostic grouping system. One bit of good news is that the agency may carry over several expired new technology add-on payments (NTAPs) into the coming fiscal year, a move prompted by the difficulty of collecting claims data from fiscal year 2020 due to the COVID-19 pandemic.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA says backlog of non-COVID applications will be cleared in eight weeks; NIH awards $33M for return-to-school efforts; Advamed tells CMS not to delay on MCIT.
The Biden administration’s fiscal 2022 budget proposal included an allocation for an office described as the Advanced Research Projects Agency – Health, or ARPA-H, which would receive $6.5 billion as part of the National Institutes of Health.
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