WORKWEEK

1) Can You Hear Me Now?

The FDA will now allow patients to purchase hearing aids over the counter, improving access to affordable hearing aids. Patients with perceived hearing loss can now go directly to stores or online shops and purchase hearing aids without needing a full evaluation, prescription or fitting. With an aging population, improved access to hearing aids will without a doubt be beneficial.

2) Surprise Billing Rule Sides with Providers

Federal regulators changed a small part of the No Surprise Billing Act regarding arbitration, which appeared to favor insurers over providers. The original rule stated that arbiters should start with the presumption that the median in-network rate—set by insurers, likely—is the appropriate out-of-network rate. The new rule removes this part: the presumption that the in-network rate is the “right one.”

3) Who Will Acquire Home Health Firm Signify Health?

CVS Health, Amazon, UnitedHealth Group and Option Care Health are bidding to buy home health firm Signify Health. UHG has reportedly bid $30 / share—an $8 billion+ valuation (>9x multiple). It’s fascinating to see Amazon in getting their feet into yet another acquisition of a major healthcare company. Blake covered it all here.

4) Gilead’s New HIV Drug Approved in Europe

The European Commission approved Gilead’s long-acting HIV shot Sunlenca. The drug is the first to target the virus’s capsid as opposed to traditional anti-virals which target proteases. Since the drug is administered once every six months, it’s likely to improve adherence. Sunlenca’s success was seen in the CAPELLA trial, where the drug led to undetectable viral loads in 81% of patients with multi-drug resistant HIV after 26 weeks of treatment. The FDA is likely to approve the drug as well.

5) Akili Therapeutics Goes Public

Digital therapeutics company Akili Therapeutics went public after completing its merger with SPAC, Social Capital Suvretta Holdings Corp. I. The company uses video games to treat conditions like ADHD.

6) Update on Statin Use Guidelines

The USPSTF updated its guidelines on statin use for adults 40 to 75 years with 1 or more cardiovascular risk factors and an estimated 10-year cardiovascular disease (CVD) risk of 10% or greater. Check it out here.

7) So Long Amazon Care

Amazon will shut down its Amazon Care operations by the end of the year. Earlier this year, I wrote an article about Amazon expanding its Amazon Care arm, but like all things in healthcare—things change. Amazon recently acquired One Medical, which in many ways, is similar to Amazon Care. Acquiring a whole other company may be more efficient and effective than building one from within.