Today's News and Commentary

Supreme Court has voted to overturn abortion rights, draft opinion shows Here is the Politico article that leaked the draft of the Court’s upcoming decision.
“The Supreme Court has voted to strike down the landmark Roe v. Wade decision, according to an initial draft majority opinion written by Justice Samuel Alito circulated inside the court and obtained by POLITICO…
’We hold that Roe and Casey must be overruled,’ he writes in the document, labeled as the ‘Opinion of the Court.’ ‘It is time to heed the Constitution and return the issue of abortion to the people’s elected representatives.’..
A person familiar with the court’s deliberations said that four of the other Republican-appointed justices – Clarence Thomas, Neil Gorsuch, Brett Kavanaugh and Amy Coney Barrett – had voted with Alito in the conference held among the justices after hearing oral arguments in December, and that line-up remains unchanged as of this week.”
In a related story: BREAKING: Chief Justice Roberts Launches Probe Into Leaked Abortion Draft Opinion “Chief Justice John Roberts on Tuesday asked the marshal of the U.S. Supreme Court to launch an investigation into a leaked draft opinion that suggests the high court is prepared to strike down the landmark 1973 ruling Roe v. Wade that made abortion legal in all 50 states.”
For additional background: What the Supreme Court justices have said about abortion and Roe v. Wade
Comment: Justice Alito is correct that the right to abortion is not mentioned in the Constitution—but neither is the right to receive any healthcare. If Congress ever addresses that latter right, the Court conservatives would have had to use another line of reasoning to justify their decision. Or would they have opined that abortions are not healthcare?


About Covid-19

 Post COVID-19 Syndrome in Patients with Asymptomatic/Mild Form “According to the analysis of original articles on PCS [Post Covid-19 Syndrome] among asymptomatic/mild COVID-19 patients, PCS develops on average in 30–60% of patients, mainly among women, with fatigue, shortness of breath, cough, and anosmia being the most common symptoms. The possible association between the described PCS symptoms and brain damage during coronavirus infection suggests an alternative form of the course of the disease that develops in genetically predisposed individuals with a stronger immune response (in particular women), in which it predominantly affects the cells of the nervous system with the presence of an autoimmune component, which has similarities with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome or autoimmune disautonomia. In summary, the female gender and the presence of anosmia during an asymptomatic or mild form of the disease could be predictive factors of the development of PCS, which might be caused by autoimmune damage to neurons, glia, and cerebral vessels.” [Emphasis added]

About health insurance

California Opens Medicaid to Older Unauthorized Immigrants ”On May 1, California opened Medi-Cal to older immigrants residing in the state without legal permission.
Unauthorized immigrants over age 49 who fall below certain income thresholds are now eligible for full coverage by Medi-Cal, California’s version of Medicaid, the federal-state partnership that provides health insurance to low-income people.
Unauthorized immigrants of all ages account for 40% of the state’s approximately 3.2 million uninsured residents.”

Massachusetts Supreme Judicial Court approves Optum's acquisition of Atrius “The court approved the transaction with certain conditions. These include the stipulation that Atrius will no longer be a public charity under Massachusetts law, once Atrius causes the net proceeds of the proposed transaction to be transferred to the Atrius Health Equity Foundation, and that it amend its articles of organization to remove its charitable purposes…
Atrius is a large, independent physician-led healthcare organization that provides care to more than 690,000 adult and pediatric patients. It employs 645 physicians and primary care providers, along with 421 additional clinicians.”

Maven Clinic partners with Blue Shield of California to reach 2.4M eligible members “Maven Clinic, a virtual clinic for women’s and family health, inked a partnership with Blue Shield of California to expand access to pregnancy and postpartum support.
The partnership, which began in January, opens up Maven’s virtual care platform for fertility, pregnancy and parenting to more than half of the plan’s total membership—to 2.4 million eligible members…
The launch comes amid delays in prenatal care during the pandemic, with many mothers experiencing worsening mental health and more than a third of Black mothers reporting experiencing racism during care in the past year.”

U.S. Attorney Announces Settlement Of Fraud Lawsuit Against Online Pharmacy For Overdispensing Insulin “…the United States filed and settled a healthcare fraud lawsuit against online retail pharmacy PillPack, LLC (‘PillPack’), a wholly-owned subsidiary of Amazon.com, Inc. The settlement resolves allegations that PillPack improperly billed Government healthcare programs (‘GHPs’), including Medicare and Medicaid, for more insulin pens than patients needed according to their prescriptions and falsely under-reported the days-of-supply of insulin dispensed. Under the settlement, PillPack agreed to pay approximately $5.79 million to the United States and various States that were fraudulently overbilled for insulin. As part of the settlement, PillPack also admitted and accepted responsibility for certain conduct the Government alleged in its Complaint, including that it dispensed insulin pens that exceeded days-of-supply limits imposed by GHPs.”

Medicare Advantage Plans Hit Back at Report on Coverage Denials These health plans responded to the recent HHS OIG Report (previously presented) that pointed to inappropriate denials of care. One criticism was “ that investigators raised concerns about just 33 of 247 preauth requests.”

Medicaid: Changes to outpatient prior authorization process for non-oncology drugsEffective Aug. 1, 2022, Optum®, an affiliate of UnitedHealthcare, will manage prior authorization requests for non-oncology injectable medications that are covered on the medical benefit for UnitedHealthcare Community Plans.
This change does not apply to the following states at this time: Colorado, Indiana, Maryland, Missouri, Nevada, New York, North Carolina and Ohio.
The prior authorization request process for oncology-related medications will also remain unchanged.”
About hospitals and healthcare systems

 National Hospital Flash Report, April 2022 [With data through the end of March] “The median change in Operating Margin rose 32.7% from February to March and 85.6% compared to March 2020.2 The median change in Operating EBITDA Margin increased 26.7% month-over-month and 98.1% versus March 2020.
Year-over-year (YOY), however, the median change in Operating Margin was down 48.7% and the median change in Operating EBITDA Margin declined 37.8% compared to March 2021.
Outpatient volumes improved for the month. Inpatient volumes increased, but at a slower pace compared to recent months…Surgery volumes increased as patients continued to return after the Omicron surge delayed many nonurgent procedures…
Hospitals saw some improvements in adjusted expenses month-over-month as volume growth outpaced expense growth in March, but labor shortages, supply chain issues, and inflation continue to push expenses up relative to prior years.
Compared to February, Total Expense per Adjusted Discharge and Non- Labor Expense per Adjusted Discharge both decreased 9%, and Labor Expense per Adjusted Discharge was down 8.3%.”

About pharma

Biogen scraps commercial support for Aduhelm, searches for new CEO In a MAJOR reversal, “Biogen said Tuesday alongside its first-quarter financial results that it will "substantially eliminate" the commercial infrastructure supporting its Alzheimer's disease therapy Aduhelm (aducanumab) following restrictions placed on its use in the US. The company noted that it will only retain "minimal resources" to manage patient access programmes for the anti-amyloid antibody.
The move is part of a wider reset at Biogen, which also sees the start of a search for a new CEO to replace Michel Vounatsos, as well as a number of cost-reduction measures. The drugmaker indicated that the elimination of the commercial infrastructure around Aduhelm will lead to savings of about $500 million.”
And somewhat anticlimactically: UnitedHealthcare limits Aduhelm for all health plans: 'unproven and not medically necessary' 

 Cerebral’s Preferred Pharmacy Truepill Halts Adderall Prescriptions for All Customers “Online pharmacy company Truepill Inc. said it is temporarily halting prescriptions for Adderall and other controlled substances used to treat attention-deficit hyperactivity disorder, and partner Cerebral Inc. told its clinicians to direct those orders to patients’ local pharmacies…
 [As previously reported:] Some of the nation’s largest pharmacies have blocked or delayed prescriptions over the past year from clinicians working for telehealth startups that have sprung up to treat ADHD, according to pharmacies and people familiar with the issue.”

FDA expands approval of non-stimulant ADHD drug to adults “The Food and Drug Administration (FDA) has expanded its approval of a non-stimulant drug for ADHD, the first in about 20 years, to include adults along with children.
Viloxazine, sold commercially as Qelbree in extended-release capsules, has been approved to help treat ADHD in adults 18 and over, its maker, Supernus Pharmaceuticals, announced. 
Qelbree was first approved for treating children ages 6 to 17 with ADHD last April. At the time, it was the first such drug approved in more than 10 years for children.”

About the public’s health

Impact of Canada’s menthol cigarette ban on quitting among menthol smokers: pooled analysis of pre–post evaluation from the ITC Project and the Ontario Menthol Ban Study and projections of impact in the USA “After the menthol cigarette ban, menthol smokers were more likely than non-menthol smokers to have quit smoking among daily smokers (difference=8.0%; 95% CI: 2.4% to 13.7%,p=0.005) and all (daily+non-daily) smokers (difference=7.3%; 95% CI: 2.1% to 12.5%,p=0.006). The projected number of smokers who would quit after a US menthol ban would be 789 724 daily smokers (including 199 732 African Americans) and 1 337 988 daily+non-daily smokers (including 381 272 African Americans).” 

Vegetarian Diet, Growth, and Nutrition in Early Childhood: A Longitudinal Cohort Study “Evidence of clinically meaningful differences in growth or biochemical measures of nutrition for children with vegetarian diet was not found. However, vegetarian diet was associated with higher odds of underweight.”
Before accepting the message as a blanket endorsement, read the article for the diet’s characteristics.

The brain structure and genetic mechanisms underlying the nonlinear association between sleep duration, cognition and mental health Among the findings of this research: “Using data from the UK Biobank for participants primarily of European ancestry aged 38–73 years, including 94% white people, we identified a nonlinear association between sleep, with approximately 7 h as the optimal sleep duration, and genetic and cognitive factors, brain structure, and mental health as key measures.”

About healthcare IT

 FDA Says It Won’t Regulate Public Health Software as a Medical Device  “The FDA has clarified that it does not plan to regulate most software apps used in public health — such as the case-counting software programs that have been in use throughout the pandemic — as medical devices.” 

Mayo Clinic uses AI and Apple Watch to detect weak heart pump “Researchers at the Mayo Clinic developed an algorithm that, using the ECG from an Apple Watch, could identify patients with a weak heart pump.
In a post on the Mayo Clinic website, researchers announced the results of the study which was also presented at the Heart Rhythm Society conference on Sunday, May 1.”

Validation of artificial intelligence prediction models for skin cancer diagnosis using dermoscopy images: the 2019 International Skin Imaging Collaboration Grand Challenge “When comparing algorithms to expert dermatologists (2460 ratings on 1269 images), algorithms performed better than experts in most categories, except for actinic keratoses (similar accuracy on average) and images from categories not included in training data (26% correct for experts vs 6% correct for algorithms, p<0·0001). For the top 25 submitted algorithms, 47·1% of the images from categories not included in training data were misclassified as malignant diagnoses, which would lead to a substantial number of unnecessary biopsies if current state-of-the-art AI technologies were clinically deployed.
Interpretation: We have identified specific deficiencies and safety issues in AI diagnostic systems for skin cancer that should be addressed in future diagnostic evaluation protocols to improve safety and reliability in clinical practice.”

Allscripts Closes Sale of Hospital and Large Physician Practices Business to Constellation Software Yesterday, Allscripts “announced that it has completed the sale of the net assets of the Allscripts Hospital and Large Physician Practices business segment to Constellation Software Inc., through its wholly-owned subsidiary N. Harris Computer Corporation.”
The deal does not include Veradigm, Allscripts' payer and life sciences division.

CERNER REPORTS FIRST QUARTER 2022 RESULTS “2022 First Quarter Highlights

  • Revenue of $1.430 billion, up 3% compared to $1.388 billion in the first quarter of 2021.

  • GAAP operating margin of 17.6%, up 190 basis points from 15.7% in the year-ago quarter.

  • Adjusted Operating Margin (non-GAAP) of 22.7%, up 130 basis points from 21.4% in the year-ago quarter.”