Becker’s Hospital Review and Fierce Healthcare report on the President’s State of the Union address from a healthcare standpoint. At the same time, the Society for Human Resources management does the same for workplace policies.

Bloomberg adds

The federal budget deficit is widening rapidly, according to the latest estimates by the Congressional Budget Office, raising the risk of the Treasury running out of cash earlier than expected amid a debt-ceiling standoff.

The excess of spending over receipts totaled $459 billion for the first four months of the fiscal year, which started Oct. 1, according to CBO estimates released on Wednesday. That’s a $200 billion increase over the same period a year earlier. * * *

Among the causes of the drop in revenue, the CBO noted that the Treasury is no longer receiving as much from the Federal Reserve, which is now paying out more in interest to commercial banks on the reserves they park at the Fed. 

Corporate-tax revenue has also dipped, while individual income-tax refunds rose, the CBO also said. Meantime, spending on areas including Social Security, Medicare and Medicaid have jumped over the fiscal year through January, the agency said.

From the U.S. healthcare business front —

CVS Health announced “strong fourth quarter and full-year 2022 results” and “entering into a definitive agreement under which CVS Health will acquire [primary care provider] Oak Street Health in an all-cash transaction at $39 per share, representing an enterprise value of approximately $10.6 billion.” As the Sopranos would say that’s a lot of boxes of ziti.

STAT News and Healthcare Dive explore the transaction. Of immediate note from Healthcare Dive

In a statement, the companies said they expect the transaction to close this year, subject to closing conditions. ​​​​​However, it will likely face regulatory scrutiny. One antitrust advocacy group is already opposing the deal. * * *

In addition, CVS is still trying to close its $8 billion buy of home health provider Signify Health. The deal, which CVS said it expects to close in the first half of 2023, is under Department of Justice review, and a new buy could threaten that process, bankers told Axios. * * *

STAT News also highlights five health tech startups targeting chronic kidney disease — Monogram Health, Cricket Health, Strive Health, Healthmap Solutions, and Square Knot Health.

From the FDA / Rx Coverage front

The American Medical Association tells us

The Food and Drug Administration Friday cleared for commercial distribution a test to diagnose multiple respiratory viral and bacterial infections in respiratory specimens from patients with suspected COVID-19 or other respiratory infections. The BioFire SPOTFIRE Respiratory Panel is the first COVID-19 test cleared with a Clinical Laboratory Improvement Amendments waiver, meaning any laboratory with at least a CLIA certificate of waiver can perform the test.

GenomeWeb adds

“We believe the BioFire Spotfire solution is a real game changer in patient care, allowing physicians to give patients an accurate and rapid diagnosis, using only one test, during the actual patient visit,” Pierre Boulud, chief operating officer, clinical operations at BioMérieux, said in a statement. “Our syndromic offer[ing] will cover most patient care settings in the US, expanding our business coverage and opportunities dramatically.”

According to BioMérieux’s website, the Spotfire R Panel uses a nasopharyngeal swab sample to detect as many as 15 targets including SARS-CoV-2, the cause of COVID-19. Other viral targets include influenza A and B virus, parainfluenza virus, respiratory syncytial virus (RSV), human rhinovirus, human metapneumovirus, seasonal coronavirus, and adenovirus. Bacterial targets include Bordetella pertussis, B. parapertussis, Chlamydia pneumoniae, and Mycoplasma pneumoniae. The panel’s full commercial launch in the US is expected in April.

That’s cool.

BioPharma Dive informs us,

One of the nation’s largest healthcare insurers has changed its policy for a new and in-demand ALS medicine, deciding not to cover it due to “a lack of clinical efficacy data.”

Cigna considers the medicine, called Relyvrio, to be “experimental, investigational or unproven” and now won’t cover it for the treatment of ALS, or amyotrophic lateral sclerosis. Relyvrio was developed by the Massachusetts-based biotechnology company Amylyx Pharmaceuticals, and approved by the Food and Drug Administration last September.

At the time of the FDA action, the New York Times reported

A new medication for A.L.S., the devastating neurological disorder that causes paralysis and death, will have a list price of $158,000 a year, its manufacturer disclosed Friday.

The treatment, to be marketed as Relyvrio, is a combination of two existing drugs and will be available to patients in the United States in about four to six weeks, according to officials of the company, Amylyx Pharmaceuticals.

Relyvrio was approved by the Food and Drug Administration on Thursday, even though the agency’s analysis concluded there was not yet sufficient evidence that the medication could help patients live longer or slow the rate at which they lose functions like muscle control, speaking or breathing without assistance.

The F.D.A. decided to greenlight the drug instead of waiting until 2024 for results of a large clinical trial partly because the treatment is considered to be safe. The agency said that although the evidence of effectiveness was uncertain, “given the serious and life-threatening nature of A.L.S. and the substantial unmet need, this level of uncertainty is acceptable in this instance.”

Amylyx officials predicted that most patients would pay little or nothing for the treatment because the company expects insurers, both private and public, to cover it. Amylyx plans to provide it free to uninsured patients experiencing financial hardship.

Still, the list price is much higher than that recommended by the Institute for Clinical and Economic Review, a nonprofit organization that evaluates the value of medicines. In a statement, the group’s chief medical officer, Dr. David Rind, said that while “there are clear benefits to patients with a rapidly fatal disease to have early access to a safe therapy,” his organization had concluded that “an annual price of $9,100 to $30,700 would be reasonable if the therapy actually works.”

Dr. Rind added that “while awaiting proof, we believe that patients would benefit from a price closer to the price of production of Relyvrio rather than a price more than five times higher than the top of a value-based range.”

It’s complicated.