Today's News and Commentary

About health insurance/insurers

Biden administration aims to crack down on short-term health plans, surprise medical billing The Biden administration announced plans on Friday to tamp down on short-term health plans and surprise medical fees as part of an ongoing effort to lower healthcare costs.
Under the new rules, if finalized, plans that claim to be “short-term” health insurance would be limited to just three months, or a maximum of four months, if extended – instead of the current three-year maximum. And, under the proposed rules, plans are required to provide consumers with a clear disclaimer that explains the limits of their benefits, including to existing consumers currently enrolled in these plans…
And, nonparticipating providers and nonparticipating emergency facilities cannot evade the protections of the No Surprises Act, including the prohibition on balance billing, by renaming charges otherwise prohibited under the No Surprises Act as ‘facility fees,’ the White House said.”

A Closer Look at the Five Largest Publicly Traded Companies Operating Medicaid Managed Care Plans FYI.

About hospitals and healthcare systems

CMS Hospital Value-Based Programs: Refinements Are Needed To Reduce Health Disparities And Improve Outcomes Note that the study was sponsored by the Federation of American Hospitals.
“We found statistically significant positive relationships between hospital penalties and several factors that affect hospital performance but that hospitals cannot control—namely, medical complexity (as measured by Hierarchical Condition Categories scores), uncompensated care, and the portion of hospital catchment area populations who live alone. Moreover, these environmental conditions can be worse for hospitals that operate in areas with historically underserved populations. This suggests that the CMS programs might not adequately account for health equity factors at the community level. Refinements to these programs (including an explicit incorporation of patient and community health equity risk factors) and continued monitoring will help ensure that the programs work as intended in a fair and equitable fashion.”

About pharma

Association of Advisory Committee Votes With US Food and Drug Administration Decision-Making on Prescription Drugs, 2010-2021 In this qualitative study, there was consistent alignment between advisory votes and FDA action across years and subject areas, but the number of meetings decreased over time. Discordance between FDA actions and advisory committee votes was most frequently an approval after a negative vote. This study demonstrated that these committees have played a key role in the FDA’s decision-making process but that the FDA sought independent expert advice less frequently over time even as it continued to follow it. The role of advisory committees in the current regulatory landscape should be more clearly and publicly defined.”

About healthcare IT

A Buyer’s Guide to Digitally-Assisted Provider Documentation Look at the chart in the article. The value of the method must take into account the time reduction benefit. That said, the scribe systems have a higher value than “Tech-enabled humans” or “Intelligent documentation.” 

About health technology

Marketing and US Food and Drug Administration Clearance of Artificial Intelligence and Machine Learning Enabled Software in and as Medical Devices  Question  Are medical devices that are marketed as enabled for artificial intelligence (AI) or machine learning (ML) being appropriately approved for AI or ML capabilities in their US Food and Drug Administration (FDA) 510(k) clearance?
Findings  In this systematic review of 119 public 510(k) application summaries and corresponding marketing materials, devices with significant software components similar to devices flagged in the FDA’s published list of AI- or ML-enabled devices were defined and taxonomized into categories of adherent, contentious, and discrepant devices. Of 119 devices queried, 12.6% were considered discrepant, 6.7% were considered contentious, and 80.6% were consistent between marketing and FDA 510(k) clearance summaries.
Meaning  These findings suggest that there were discrepancies between the marketing and 510(k) clearance of AI- or ML-enabled medical devices, with some devices marketed as having such capabilities not approved by the FDA for use of AI or ML.”

About healthcare finance

Coloplast casts $1.3B to reel in fish skin-based wound care company Kerecis “The Danish medtech announced plans on Friday to acquire Kerecis, which uses fish skin as the basis of its wound care products for humans.
Coloplast has offered up 8.9 billion Danish kroner, or around $1.3 billion, in the deal. The vast majority—8.2 billion kroner ($1.2 billion)—will be doled out as an upfront cash payment. Coloplast intends to finance the acquisition with help from an equity capital raise.”