The tricuspid valve at times seems the lost child of the heart’s valves, but new research hints that regurgitation of this valve can be resolved with a transcatheter replacement. Adam Greenbaum, of Emory University School of Medicine, said the early feasibility study of the Pascal valve by Edwards Lifesciences Inc., of Irvine, Calif., demonstrated a large improvement in mortality at one year and significant improvements in heart failure status, a result that offers new hope for these patients.

The Senate Health, Education, Labor and Pensions (HELP) Committee met April 5 to review the user fee agreements for the drug and device centers, but one member of the committee was quite vocal about the ever-growing volume of user fees. Sen. Richard Burr (R-N.C.) said the pace with which user fees are increasing suggests that the FDA is growing increasingly independent of Congress.

There has been some skepticism about the value of electronic health records (EHRs) beyond their role as a source of income for EHR developers, but an April 3 presentation at the 2022 America College of Cardiology scientific sessions being held in Washington suggests this type of software offers some real value for heart failure patients. Tariq Ahmad of Yale School of Medicine said a study of EHRs suggests their power lay in part in prompting compliance with heart failure medication regimes, an application of this type of software that can both save lives and cut costs for the Medicare program and Medicare beneficiaries.

Pharmaceutical agents took center stage in Washington on the first full day of the 2022 scientific sessions of the American College of Cardiology, such as an April 2 presentation on the use of the mavacamten for obstructive hypertrophic cardiomyopathy (OHC). Milind Desai of the Cleveland Clinic said 16-week data for this cardiac myosin inhibitor showed well in reducing heart failure class status, but there are data arising from studies in China which suggest that radiofrequency (RF) ablation might also work for these patients.

Bringing a new medical device or diagnostic to market has never been a small feat for small companies, and regulatory review is still one of the largest hurdles facing device makers. However, a new report by Boston Consulting Group (BCG) and the UCLA Biodesign program shows that the twin issues of coverage and reimbursement still combine to present the most difficult hurdle to overcome for med-tech companies.

The U.S. Preventive Services Task Force (USPSTF) has decided to consider the merits of screening for obstructive sleep apnea (OSA), a condition thought to contribute significantly to the onset of heart disease. Even though five years have passed since the task force considered the merits of screening for asymptomatic patients, USPSTF indicated that there is still insufficient evidence to support the proposition, citing an evidence gap that if filled could prove tremendously useful to makers of devices that diagnose and treat the condition.

Negotiations between the U.S. FDA and industry over device user fees were a protracted struggle, but the agency was demonstrably loathe to post the minutes from meetings between the agency and industry representatives. Jeff Shuren, director of the FDA’s device center, said in a congressional hearing that those minutes were not posted because of a need to wrap up the negotiations rather than allow outsiders – including members of Congress – to see how difficult the negotiations had become.

While the Medicare Coverage of Innovative Technologies (MCIT) program has been formally abandoned, the U.S. CMS has resurrected those policy underpinnings in the form of the Transitional Coverage for Emerging Technologies (TCET) concept. Several speakers on a recent webinar said the TCET paradigm should allow CMS to promptly rescind coverage in the event of a safety signal, including Mark McClellan, who has served as both FDA commissioner and CMS administrator.