Today's News and Commentary

About Covid-19

 Pfizer and BioNTech seek emergency-use authorization of the first coronavirus vaccine for children under 5: Pfizer and BioNTech said Tuesday they were seeking emergency-use authorization for the first coronavirus vaccine for children younger than 5 and have begun submitting data on the safety and efficacy of the first two doses of a planned three-dose regimen.
The data has not yet been published or peer-reviewed, but the Food and Drug Administration requested the company to move forward with an application due to the “urgent public health need in this population,” the companies said in a statement, noting that 1.6 million children under the age of 4 have tested positive for the coronavirus.”

Medical boards get pushback as they try to punish doctors for Covid misinformation: “In all, medical boards have sanctioned eight physicians since January 2021 for spreading coronavirus-related misinformation, according to the Federation of State Medical Boards, which has recommended that health officials consider action against medical professionals who dispense false medical claims in public forums. The eight penalized doctors, who’ve been hit with discipline from suspension to revocation of licenses, represent a surprising figure, considering the time it takes for state boards to mete out punishment. The targets of investigations have cited their own scientific expertise in recommending alternative courses of treatment.”

About health insurance

Medicare Advantage receiving bipartisan support in House of Representatives : “More than 340 members of the U.S. House of Representatives… signed a letter late last week to the Centers for Medicare and Medicaid Services, urging the agency to maintain stability with Medicare Advantage, contending that it provides affordable, high-quality health coverage.
In total, 346 representatives signed the letter, topping the previous record of 339; this amounts to 80% of the chamber. It comes as CMS prepares its annual rate-setting process, in which the agency will announce key decisions related to Medicare Advantage beneficiaries' funding for the 2023 plan year.”
What is the real reason for the support?
”The Congressional letter follows polling in Morning Consult that shows 92% of Medicare Advantage beneficiaries consider a candidate's support for the program as important to earn their vote.”

Insurers stretched supplier bonuses, quality investment to avoid discounts, says CMS: “A rule to suppress The way commercial insurance companies spend consumer premium dollars could flip supplier compensation and accelerate acceptance of value-based contracts, experts say.
The Centers for Medicare and Medicaid Services proposed in December that provider bonuses, included as claims arise in insurers’ medical loss ratios, be explicitly linked to standards of quality or clinical improvement. CMS also recommended that only costs directly attributable to quality improvement be considered for insurers’ quality improvement requirements in their MLR…
After an MLR review of a number of health insurance plans, regulators said some insurers should be giving consumers back a larger piece of the pie.Health plans offered bonuses to providers instead of returning excess profits to patients, according to the proposed CMS rule. While some bonuses and incentives should be counted in MLR reports because they motivate and reward high-quality care, offering bonuses to bypass discounts misses the point, the agency said.”

Universal health care bill fails to pass in California: “A bill that would have created the nation’s only government-funded universal health care system died in the California Assembly on Monday as Democrats could not gather enough support to bring it for a vote ahead of a legislative deadline.”

GuideWell closes $900M Triple-S acquisition, brings enrollment to 46 million people: “Florida Blue parent company GuideWell finalized its acquisition of Puerto Rico-based Blue Cross Blue Shield affiliate Triple-S Management Corp., according to a news release shared with Becker's
The payer announced its intent to acquire Triple-S for $900 million in August 2021. The move would strengthen the companies' footholds in Florida and Puerto Rico.”

A Medicaid and Children’s Health Insurance Program Primer and Reform Outline: An excellent, current monograph.

About hospitals and healthcare systems

 CMS cuts payments to 764 hospitals over patient complications: “CMS will trim 764 hospitals' Medicare payments in fiscal year 2022 for having the highest rates of patient injuries and infections, according to Advisory Board
The Hospital-Acquired Conditions Reduction Program aims to prevent harm to patients by providing a financial incentive for hospitals to prevent hospital-acquired conditions. Under the program, a hospital's total score is based on performance on several quality measures, including rates of infections, blood clots and other complications that occur in hospitals and might have been prevented.”

National Hospital Flash Report: January report from KaufmanHall.
“Takeaways at a Glance:

  1. Hospitals are still performing well below 2019 levels without CARES Act funding.
    Hospitals have yet to rebound to pre-pandemic levels of margins and volumes, while risingrevenues have been offset by escalating expenses.

  2. Hospitals performed better in 2021 than in 2020.
    In 2021, hospitals rebounded somewhat from the first year of the pandemic—when providers nationwide shuttered elective services for weeks and months on end.

  3. Labor expenses continue to drive accelerating overall expenses.
    Labor costs rose above both 2020 and 2019 levels in 2021, contributing significantly to increased overall expenses and dampening hospital margins. The increases occurred as hospitals were hit with intense staffing shortages, reflected in declining FTEs per AOB [Adjusted Occupied Bed].

  4. Hospitals began feeling Omicron’s impact in December.
    Hospitals saw rising volumes in December, as patient days and ED visits rose. A flat month for
    OR minutes suggests that many providers and non-COVID patients may have cancelled care due to rising COVID caseloads—a trend that has been seen in previous waves of the pandemic.

About pharma

 Novartis' Sandoz reportedly the target of $25B buyout bid from Carlyle and Blackstone : “As Novartis reviews its generics business, the list of potential Sandoz suitors has grown. The deal could become one of the biggest generic industry acquisitions ever—assuming an offer makes it across the finish line.
Investor groups Blackstone and Carlyle could join forces on a massive $25 billion bid for Sandoz…”

Principles of Premarket Pathways for Combination Products: This latest FDA document addresses approval processes for companies that manufacture combination products. “As set forth in section 503(g) of the FD&C Act and 21 CFR part 3, a combination product is a product comprised of two or more different types of medical products (i.e., a combination of a drug, device, and/or biological product with one another). The drugs, devices, and biological products included in combination products are referred to as constituent parts of the combination product.”

Drug distributor to pay $13M to settle kickback allegations: “Pharmaceutical distributor Cardinal Health Inc. has agreed to pay more than $13 million to resolve allegations that it violated federal law by paying kickbacks to some doctors' offices, federal authorities said Monday.
Cardinal Health induced physician practices to buy medications from Cardinal rather than from competitors by paying those practices in advance of any drug purchases, and not in connection with any specific purchases, according to the settlement.”

Native American tribes reach landmark opioid deal with Johnson & Johnson, drug distributors for up to $665 million: “In the largest opioid settlement for Native Americans, the country’s three major drug distributors and Johnson & Johnson will pay up to $665 million to tribal communities…”

About the public’s health

 Blockbuster cancer med Keytruda may help flush out dormant HIV, suggesting a new way to treat long-running epidemic: “ A team at the Fred Hutchinson Cancer Research Center and other collaborators found that the immunotherapy helped dormant HIV exit the immune cells and may also shrink the shrouded pool of HIV that has befuddled drug development to-date.”

Exclusive: U.S. diabetes deaths top 100,000 for second straight year: “More than 100,000 Americans died from diabetes in 2021, marking the second consecutive year for that grim milestone and spurring a call for a federal mobilization similar to the fight against HIV/AIDS…
A report released earlier this month calls for far broader policy changes to stem the diabetes epidemic, such as promoting consumption of healthier foods, ensuring paid maternal leave from the workplace, levying taxes on sugary drinks and expanding access to affordable housing, among other areas.”
Viruses come and go, but unless things change, we will always have at least this many people dying from diabetes.

About healthcare IT

 Nearly 2M medical records breached in January: A breakdown: “In January, 38 organizations reported to HHS that 1,991,781 individuals were affected by data breaches.” Broward Health (Fort Lauderdale, Fla.) accounted for 1,351,431 of the total.

How a decades-old database became a hugely profitable dossier on the health of 270 million Americans: “The family of databases that make up MarketScan now include the records of a stunning 270 million Americans, or 82% of the population.”
This piece is a fascinating look at monetization of patient information.

About healthcare personnel

DaVita loses bid to dismiss DOJ's criminal antitrust charges: A Colorado federal judge on Friday declined to dismiss a criminal antitrust indictment alleging dialysis provider DaVita Inc and its former CEO Kent Thiry conspired with competitors not to hire each other's senior employees, upholding a closely watched prosecution in the labor and employment arena.”
This case is one of many recently in the courts that looks at restrictive covenants and other measures companies use to impede free movement of healthcare personnel.