Medicare coverage does not necessarily mean appropriate reimbursement levels, a point pressed by Inspire Medical Systems Inc. at the Aug. 23 Medicare outpatient advisory panel hearing. The panel agreed that the company’s hypoglossal nerve stimulation (HNS) device for sleep apnea was subject to an inappropriate device offset figure, which could lead to a Medicare rate increase of more than $7,000 and a significant boost of sales of the company’s flagship Inspire HNS device.

The quiet cancellation of an Aug. 24 meeting in which the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) was supposed to discuss COVID-19 vaccine boosters is raising more questions about whether the Biden administration got ahead of the data with its Aug. 18 announcement that it planned to roll out mRNA booster shots to adults beginning next month.

As the U.S. House of Representatives resumes work Aug. 23 on a budget reconciliation proposal to get a $3.5 trillion fiscal 2022 budget across the finish line, many lawmakers are looking to provisions to reduce prescription drug prices as a way to pay for increased spending in other health care sectors.

The FDA has granted full approval to Pfizer Inc.’s COVID-19 vaccine in a move that is hoped will convince unvaccinated citizens that the shot is safe and effective. The mRNA vaccine, which will be branded as Comirnaty and was first developed by Germany’s Biontech SE, has been available since Dec. 11 last year under an emergency use authorization (EUA) and is the first to receive the FDA’s full endorsement.

Cardiac Dimensions Inc. launched the Empower trial of its Carillon mitral contour system for the treatment of heart failure patients with early-stage functional mitral regurgitation. The company expects to enroll up to 300 patients at 75 sites in the international, randomized, sham-controlled trial.

The FDA said it has withdrawn the accreditation of Accelerated Device Approval Services LLC (ADAS), of Miami, for making false presentations about one of the company’s employees. Among the allegations are that the company named a reviewer who was never employed by ADAS, and that the company misled a client about the status of a regulatory filing.

The Biden administration’s rollout of a COVID-19 booster plan before the FDA has even approved a booster admittedly is a “judgment call,” U.S. health officials acknowledged Aug. 18. But rather than a judgment call, “the introduction of booster doses should be evidence-driven and targeted to the population groups in greatest need,” the World Health Organization advised in an interim statement issued a week before the White House COVID-19 Response Team’s announcement.

The FDA’s emergency use authorization (EUA) program is still active in the area of tests and test kits, which is due in part by the emergence of the Delta variant of the SARS-CoV-2 virus and the associated warnings that the effectiveness of vaccines may be declining. One example of the sustained emphasis on testing is the EUA granted to Thermo Fisher Scientific Inc. for two PCR test kits that can detect the latest variants of the virus, a demonstration that the demand for these updated tests seems unlikely to ebb anytime soon.

Plans for offering COVID-19 vaccine booster shots in the U.S. took a big step forward Aug. 18, as Health and Human Services (HHS) public health and medical experts laid out their intention to offer booster shots across the country for people 18 and older beginning the week of Sept. 20 and starting eight months after an individual's second dose.