The U.S. Senate and the House of Representatives have reintroduced the Verifying Leading-edge IVCT Development (VALID) Act, a bill that would authorize the FDA to regulate lab-developed tests (LDT). The question of the agency’s statutory authority to regulate LDTs is part of a long-running debate, but the immediate question is whether Congress will see fit to deal with the question this year rather than wait until 2022, when the next device user fee will require legislative authorization.

The follow-up to the U.S. 21st Century Cures Act, dubbed Cures 2.0, encodes several anticipated features such as a Medicare coverage mechanism for breakthrough devices and the Advanced Research Projects Agency for Health (ARPA-H). Less expected was a provision for the use of real-world evidence in evaluation of the safety and effectiveness of drugs and biologics after FDA approval, a provision that could prove useful in post-approval evaluations of products such as Biogen’s Aduhelm.

The June report to Congress by the Medicare Payment Advisory Commission (MedPAC) encodes several suggestions as to how rates would be determined under the Medicare clinical lab fee schedule (CLFS), such as the use of competitive bidding for laboratory tests. That and other policy concepts earned a quick reply by the American Clinical Laboratory Association (ACLA), which said that bidding and other concepts either repeat the mistakes of recent history or fail to account for the prospect that these mechanisms could impose artificially low rates for tests and ultimately hamper patient access.

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.

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).