Today's News and Commentary

About Covid-19

Pfizer booster now available to older Americans and those at higher-risk, including on the job, as CDC chief partly overrules panel: “In a rare move, CDC Director Rochelle Walensky late Thursday overruled her agency’s advisory panel and added a recommendation for boosters for people whose jobs put them at risk of infection.
The advisory panel had made a recommendation that largely mirrored an authorization issued a day earlier by the Food and Drug Administration, with a call for a third shot of the Pfizer-BioNTech vaccine for people 65 and older, nursing home residents and people 50 to 64 with underlying medical conditions six months after completing their second shot.”

Another judge rules against Tennessee governor letting parents opt out of school mask mandates: “A second federal judge on Friday batted down Tennessee Gov. Bill Lee’s (R) order letting parents exempt themselves from school mask mandates….
U.S. District Judge J. Ronnie Greer ruled Knox County Schools has to require face coverings to protect students with medical issues from the coronavirus, the news outlet reported. Greer’s order also blocks Lee’s policy from implementation while the lawsuit is ongoing.

About pharma

CMS official says Medicaid must cover Aduhelm as industry awaits national coverage decision: “The Centers for Medicare & Medicaid Services is advising state Medicaid programs that they must cover Biogen and Eisai's controversial Alzheimer's drug Aduhelm as an outpatient drug.
Biogen participates in Medicaid's drug rebate program. John Coster, director of pharmacy in CMS' Center for Medicaid and CHIP Services, said during a conference hosted this week by America's Health Insurance Plans that states can set their own medical eligibility criteria for the drug.
‘As I've said to states and others who have asked, Aduhelm is currently a covered outpatient drug,’ Coster said. ‘The manufacturer is a participating labeler in the program. The states can develop medical necessity criteria around that drug, or any other drug, but it is a covered outpatient drug.’”

Centene and Humana sue Merck over alleged drug deal: “Insurance companies Humana and Centene filed separate claims in New Jersey District Court on Wednesday. Both say [they overpaid ] Merck… hundreds of millions of dollars on cholesterol drugs Vytorin and Zetia due to the ‘pay-for-delay’ tactic. The complaints came just three months after the Kaiser Foundation Health Plan sued Merck, accusing the company of violating antitrust laws in many states by delaying the release of cheaper generic drugs.”

Facing class action lawsuit over insulin pricing, Novo Nordisk inks $100M settlement with disgruntled investors: ”After Novo Nordisk allegedly told investors it was resistant to industrywide insulin pricing pressures, some shareholders brought a class action lawsuit claiming they were misled. On Friday in a federal district court in New Jersey, Novo Nordisk agreed to a $100 million settlement with those disgruntled investors.”

About health insurance

What Has Become of the Affordable Care Act?: A really good summary of what has happened to the ACA since its passage.

Assessment of Costs and Care Quality Associated With Major Surgical Procedures After Implementation of Maryland’s Capitated Budget Model: “In this comparative effectiveness study of 525 262 Maryland patients who received surgery before and after implementation of Maryland’s all-payer model, lower complication rates were observed for coronary artery bypass grafting (11% decrease), carotid endarterectomy (2% decrease), hip arthroplasty (1% decrease), knee arthroplasty (<1% decrease), and cesarean delivery (1% decrease). Smaller estimated changes in hospital costs vs other states were also observed, with increases reduced by $6236 for coronary artery bypass grafting, $730 for carotid endarterectomy, $328 for hip arthroplasty, $415 for knee arthroplasty, $300 for cesarean delivery, and $745 for hysterectomy.”

CMS approves Clover Health's expansion into 101 new counties: “CMS gave Nashville, Tenn.-based Clover Health the go-ahead to expand into 101 new counties between five states — including Alabama, which it will be entering for the first time. 
The expansion nearly doubles Clover's reach, which swells to 209 counties…
In addition to Alabama, the insurer is entering counties in Georgia, New Jersey, South Carolina and Texas.”

CMS Reevaluating Hospital Outpatient Pay Rate Cut Exemptions: “CMS is reevaluating hospitals’ applications for exceptions from reimbursement cuts to their off-campus outpatient facilities following pushback from the industry.
In January, CMS rejected more than 60% of the mid-build exceptions, which is designed to preserve higher payments if hospitals document that their off-campus outpatient departments were under construction when the Bipartisan Budget Act passed in 2015.
Without the exception, reimbursement rates drop to 40% of the full outpatient prospective payments system rate. Hospitals would also be liable for overpayments issued starting Jan. 1, 2018, if they billed via OPPS.”

About the public's health

5000 alcohol-related cancer deaths could be prevented every year by doubling alcohol taxes in the European Region, says WHO/Europe: Another reminder that taxation is the best tool to control harmful behavior.

J&J Cleared of Responsibility for Woman’s Talc-Cancer Claim: “Johnson & Johnson isn’t responsible for a Pennsylvania woman’s cancer that she blamed on the company’s talc-based powders, a jury ruled in the company’s latest win in the nationwide litigation over its iconic baby powder.
Jurors in state court in Philadelphia concluded Friday J&J’s talc-based baby powder didn’t contribute to the onset of Ellen Kleiner’s ovarian cancer and the company doesn’t have to pay damages.
It’s J&J’s first win this year in cases targeting its well-known baby powder.”

A Unifying Approach for GFR Estimation: Recommendations of the NKF-ASN Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Disease: The major kidney disease organizations recommend eliminating kidney function measures that were different for black patients because they lead to worse outcomes for those patients.

Cancer statistics for the US Hispanic/Latino population, 2021: “Compared to non-Hispanic Whites (NHWs), Hispanic men and women had 25%-30% lower incidence (2014-2018) and mortality (2015-2019) rates for all cancers combined and lower rates for the most common cancers, although this gap is diminishing.”
Read the article for more details.

About healthcare IT

Walmart, large employers launch virtual care service to tackle Black health disparities: “Walmart is partnering with virtual care company Grand Rounds Health and Doctor On Demand on a digital health program aimed at tackling health disparities among African American workers.
Walmart and a group of other large employers including Accenture, Best Buy, Genentech, Medtronic, State Farm and Target are spearheading a new initiative called the Black Community Innovation Coalition in partnership with the virtual care company.
Combined, the group employs more than 500,000 African American workers.
The companies say it's the first dedicated care concierge and healthcare navigation platform focused on improving the healthcare experience and advancing health equity for Black Americans. The goal is to create a culturally specific concierge service to engage workers of color on their health.”

UnitedHealthcare to make Apple Fitness+ available in fully insured employer plans: “Beginning Nov. 1, members in fully insured plans who already own an Apple Watch will be able to sign up for a yearlong Apple Fitness+ subscription for free. This covers about 3 million members across most states, UnitedHealthcare said.
Self-funded employers will have the option to add an ‘Apple Fitness+ bundle’ to their coverage next year, which will provide the subscription as well as a $25 digital Apple gift card to members.”

'Privacy Exception' No Cure for Doctors' Open Notes Headaches: “Some physicians are bridling at last week's federal advisory suggesting they can delay releasing bad news to patients' electronic health portals without violating the new federal law that requires it. Their patients just have to request the delay up front.
The framework for doing that is embedded in the "Privacy Exception," one of eight exceptions in the new Information Blocking or "Open Notes" rule. This one allows "actors" (i.e., clinicians) to withhold releasing health information to a patient if that release could harm the patient, according to a spokesman for the Office of the National Coordinator for Health Information Technology (ONC), which is administering the rule.”

About medical devices

GE Healthcare to Acquire BK Medical for ~ $1.45B:

  • “GE has signed an agreement to acquire BK Medical for $1.45B in cash and is eligible to receive a high-single-digit return on invested capital within 5yrs. The transaction is expected to close in 2022

  • The acquisition will allow GE Healthcare to expand its $3B ultrasound business from diagnostics into surgical & therapeutic interventions. The acquisition also accelerates its growth in precision health & adds capability in the surgical visualization segment

  • BK Medical provides ultrasound technology that can be used during surgery to guide clinicians. GE Healthcare anticipates BK Medical to deliver rapid revenue growth, margin expansion, and free cash flow growth