Today's News and Commentary

About Covid-19

Newer, fitter descendants of Omicron variant begin to drive their own coronavirus waves Average daily hospitalizations are up about 10% since last week, according to data collected by the US Department of Health and Human Services.
The culprit this time appears to be a spinoff of Omicron's BA.2 subvariant called BA.2.12.1, which was first flagged by New York state health officials in April.
BA.2.12.1, which is growing about 25% faster than its parent virus, BA.2, accounts for nearly 37% all Covid-19 cases across the US, according to new estimates from the CDC.
BA.2 caused an estimated 62% of all Covid-19 cases last week, down from 70% the week before.”

Pfizer Says Patients Who Relapse After Covid Pill Can Repeat Treatment “The Food and Drug Administration didn’t immediately respond to a request for comment on how the antiviral should be prescribed to Covid-19 patients who experience the rebound in viral load. While Paxlovid is available under emergency use authorization, it hasn’t yet gained full approval. Prescribing directions suggest that the drug is ‘not authorized for use for longer than 5 consecutive days.’”

HHS extends risk adjustment for COVID-19 telehealth, telephone-only services  “In response to the ongoing pandemic and need to use telehealth and virtual care options, the Department of Health and Human Services will continue to include certain telehealth and telephone-only services in its risk adjustment program for qualified health plans in plan year 2022, the Centers for Medicare & Medicaid Services announced…”

Hospitals on Edge as States Scrap Covid Emergency Declarations “Governors and legislators in states including Arizona, Idaho, Indiana, Kentucky, Louisiana, New Jersey, Oregon, Virginia, and Wyoming have rescinded their emergency declarations in the past two months, according to the National Academy for State Health Policy. More are set to expire in the coming months unless renewed. Disaster declarations in other states ended as long as a year ago, while about a third of states are holding onto their emergency measures.”

CDC reiterates importance of masks on airplanes, public transportation “Federal health officials on Tuesday repeated their recommendation that masks be worn on airplanes, buses and in other public transportation settings where large numbers of people congregate.
Despite a federal judge’s order last month striking down the federal transportation mask mandate, the Centers for Disease Control and Prevention said masks continue to be an important tool for stopping the spread of the coronavirus.”

About health insurance

CVS Health hits 44M unique digital customers in Q1 “CVS Health reported $2.3 billion in profit for the first quarter, which exceeded Wall Street's expectations.
The healthcare giant also beat the Street on revenue, posting $76.8 billion for the first quarter. Both figures are up from the first quarter of 2021, where the company reported $69.1 billion in revenue and $2.2 billion in profit.
That's a revenue increase of 11.2% year over year, according to CVS' earnings report filed Wednesday morning.”

Bright Health reports major enrollment boost, $180M loss in Q1 “Bright Health Group reported massive enrollment growth across its commercial, Medicare Advantage and value-based lines, but recorded a net loss of more than $180 million in the quarter ending March 31, according to its first-quarter earnings report…”

Oregon, Kentucky dust off an Obama-era policy to expand health insurance
Oregon and Kentucky are pursuing an Obama-era policy that uses federal dollars to establish a health insurance plan for people who make too much money to qualify for their state’s Medicaid programs…
While the policy, known as the basic health program, was included in the Affordable Care Act, only Minnesota and New York took advantage, and it has been six years since a new one was created…
A basic health program offers low-cost insurance for people who make up to twice the federal poverty level – about $55,000 for a family of four – and do not qualify for Medicaid. New York and Minnesota offer plans with little or no premiums, co-pays or deductibles, a key selling point for proponents.”

About pharma

 Vaxxinity Receives FDA Fast Track Designation for UB-311 for Treatment of Alzheimer’s Disease “Vaxxinity, Inc… . announced that UB-311, an anti-amyloid beta immunotherapeutic vaccine, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of Alzheimer’s disease….
 UB-311 is an immunotherapeutic vaccine candidate targeting toxic forms of aggregated amyloid beta in the brain to treat Alzheimer’s disease. Phase 1, Phase 2a, and Phase 2a Long Term Extension trials have shown UB-311 to be well tolerated in mild-to-moderate AD patients over three years of repeat dosing, with a safety profile comparable to placebo and no cases of amyloid-related imaging abnormalities-edema (“ARIA-E”) in the main study. UB-311 also elicited robust and durable anti-amyloid beta antibody responses in patients. A Phase 2b trial is expected to be initiated in late 2022.”
Perhaps before the company does its pricing it can take a lesson from Aduhelm.

Washington Reaches $518M Settlement With Opioid Distributors “The agreement still requires approval from a judge and from dozens of Washington cities that pursued their own cases against the distributors — McKesson Corp., Cardinal Health Inc. and AmerisourceBergen Corp.
Under the settlement, the state would have to spend $476 million of the total to address the opioid crisis, including on substance abuse treatment; expanding access to overdose-reversal drugs; and providing housing, job placement and other services for those struggling with addiction. The rest of the money would go toward litigation costs.”

Teva cuts sales guidance amid competitive pressures, currency exchange woes “The Israeli generics giant reaped revenues of $3.66 billion, down 8% from $3.98 billion during the same period last year. After the performance, the drugmaker cut its revenue guidance for the full year.”

GSK to Acquire Sierra Oncology and Its Promising Blood Cancer Drug for $1.9 Billion “GlaxoSmithKline (GSK) has prevailed over six other bidders with its $1.9 billion offer to purchase Sierra Oncology, gaining the Canadian company’s promising investigational Janus kinase (JAK) inhibitor, momelotinib, for the treatment of the rare blood cancer myelofibrosis.”

About the public’s health

 Why US Cervical Cancer Survival Rates Haven’t Improved for Decade “Although screening has been on the frontlines of the battle against cervical cancer for more than 60 years, the disease’s survival rate has barely budged since the 1970s. That’s in stark contrast with the overall cancer mortality rate in the US, which the American Cancer Society (ACS) reported has decreased by 32% since 1991.”
Read this interesting article for reasons for this lack of progress.

HHS Awards Nearly $25 Million to Expand Access to School-Based Health Services “…Health Resources and Services Administration (HRSA), awarded nearly $25 million to improve and strengthen access to school-based health services in communities across the country. Awards will support local partnerships between schools and health centers to provide children and youth the comprehensive physical and mental health care they need.”

Relationship Between Ambient Air Pollution And Incidence Of Head And Neck Cancers In Illinois “Diesel particulate matter levels were found to be associated with oral/pharyngeal cancer incidence. Greater ambient air pollution exposure may be a factor that increases pre-disposition to developing certain head and neck cancers.”

Sex-Specific Risk Factors Associated With First Acute Myocardial Infarction in Young Adults “In this case-control study, 7 risk factors (diabetes, depression, hypertension, current smoking, family history of premature MI, low household income, hypercholesterolemia) accounted for 85% of the risk of first AMI in young men and women. We further found that risk factors accounted for different risk of AMI in women compared with men, and that some of the significant factors varied by sex. Risk factors also varied by subtype of AMI, with traditional cardiovascular risk factors having higher prevalence and stronger associations for type 1 AMI compared with other types of AMI not resulting from acute plaque rupture.”

Cannabinoid receptor 1 antagonist genistein attenuates marijuana-induced vascular inflammation “A UK Biobank analysis found that cannabis was an risk factor for CVD. We found that marijuana smoking activated inflammatory cytokines implicated in CVD.”

About healthcare IT

Athenahealth adds Nuance to its digital marketplace The Nuance Dragon Ambient eXperience, which includes API integration with athenaClinicals and Athenahealth's EHR system, automates administrative tasks during virtual and in-person visits…”

About healthcare personnel

 agilon health and United Physicians form Long-term Partnership to Provide a Value-Based Care Model for Medicare Advantage in Southeast Michigan “Through the partnership, United Physicians will work with agilon health to transform its primary care delivery system for Medicare Advantage patients to a sustainable, full-risk value-based care model that will improve quality outcomes within Southeast Michigan’s healthcare system….
Today, agilon health is partnering with 16 of the nation’s best physician groups including Answer Health, Western Michigan’s largest physician organization. agilon is accelerating at scale the transition to a value-based Total Care Model for senior patients through its aligned partnerships, purpose-built platform, and peer network of like-minded physicians. Following the announcement of its partnership with MaineHealth and United Physicians, as well as the expected announcements of five additional partners for 2023, agilon health will have 23 physician partners across 12 states and 25 diverse geographies, and more than 2,200 primary care physicians in its peer network.”

Physician Flash Report: April 2022 “For the first time in two years, the median Investment/Subsidy per Physician FTE surpassed levels seen during the start of the COVID-19 pandemic. The metric was up 1.5% compared Q1 2020 at $288,227 in Q1 2022.

Other key findings from the first quarter compared to Q1 2021 include:

  • Physician wRVUs per FTE increased 15%

  • Physician Compensation per FTE rose 7% to $349,072

  • Net Revenue per Physician FTE was up 10% to $636,674

  • Total Direct Expense per Physician FTE rose 11% to $946,602”

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.”

Today's News and Commentary

About Covid-19

COVID DATA TRACKER WEEKLY REVIEW “This week, the U.S. COVID-19 Vaccination Program marks two milestones: 500 days since the first COVID-19 vaccine was approved for use in the United States, and 100 million first booster doses administered. While 100 million boosters is certainly something to celebrate, the fact remains that half of those eligible for a COVID-19 booster shot—about 91 million people—have not yet received one…
As of April 27, 2022, the current 7-day moving average of daily new cases (53,133) increased 25.2% compared with the previous 7-day moving average (42,427). A total of 81,028,797 COVID-19 cases have been reported in the United States as of April 27, 2022.”

Paxlovid fails in study for post-exposure prophylactic use While useful for treating those who become infected with SARS CoV-2, Paxlovid does not work for post-exposure prophylaxis.

 Trump officials muzzled CDC on church covid guidance, emails confirm “Trump White House officials in May 2020 removed public health advice urging churches to consider virtual religious services as the coronavirus spread, delivering a messaging change sought by the president’s supporters, according to emails from former top officials released by a House panel on Friday.
The Centers for Disease Control and Prevention sent its planned public health guidance for religious communities to the White House on May 21, 2020, seeking approval to publish it. The agency had days earlier released reports saying that the virus had killed three and infected dozens at church events in Arkansas and infected 87 percent of attendees at a choir practice in Washington state, and health experts had warned that houses of worship had become hot spots for virus transmission.”

Big Three COVID-19 Vaccine Maker Shareholders Vote No on Sharing Intellectual Property With LMICs “Shareholders of the U.S.’ big three COVID-19 vaccine makers have voted no on proposals asking the companies to share their intellectual property with low- and middle-income countries (LMICs) so that those countries could make their own versions of the vaccines.”

About health insurance

CY 2023 Medicare Advantage [MA] and Part D Final Rule (CMS-4192-F) “This final rule revises the MA and Part D regulations related to marketing and communications; the criteria used to review applications for new or expanded MA and Part D plans, including compliance with MA provider network adequacy requirements; quality ratings for MA and Part D plans; medical loss ratio reporting; special requirements during disasters or public emergencies; how MA organizations calculate attainment of the maximum out-of-pocket (MOOP) limit for Parts A and B services; and the use of pharmacy price concessions to reduce beneficiary out of pocket costs for prescription drugs under Part D. This final rule also revises regulations for D-SNPs [MA dual eligible special needs plans] and in some cases, other special needs plans, related to enrollee advisory committees, health risk assessments, and ways to improve integration of Medicare and Medicaid. Many finalized policies are based on lessons learned from the Medicare-Medicaid Financial Alignment Initiative.”
Each of these items is briefly explained.

Feds Block Georgia's Plan to Have Private Sector Handle ACA “President Joe Biden's administration on Friday halted Gov. Brian Kemp’s plan to have the private sector, not the government, engage in outreach to get state residents to sign up for insurance under the Affordable Care Act.
Kemp, a Republican, had planned to bypass healthcare.gov and have residents shop for federally subsidized health insurance through private agents. Former President Donald Trump’s administration approved that plan in 2020, and state officials had touted it as a way to boost insurance coverage.”

 Health Coverage Changes Under the Affordable Care Act: End of 2021 Update KEY POINTS:

  • Newly-released data from the National Health Interview Survey shows that the uninsured rate for the U.S. population was 8.8 percent in Q4 2021 (October – December 2021), down 1.5 percentage points from 10.3 percent in Q4 2020. This reflects approximately 4.9 million people gaining health coverage since the end of 2020.

  • Individuals with incomes below 200 percent of the Federal Poverty Level experienced larger decreases in the uninsured rate than higher income households.

  • Coverage gains for adults ages 18-64 from the second half of 2020 to the second half of 2021 occurred across all racial and ethnic groups reported in the new data, with the uninsured rate declining by 3.5 percentage points among Latino adults, 1.8 percentage points among Black adults, and 0.5 percentage points among White adults.

  • Meanwhile, administrative data from late 2021 and early 2022 show a record-high number of people with coverage related to the Affordable Care Act (ACA) – with more than 35 million people estimated to be enrolled in the Medicaid expansion, Basic Health Program, or Marketplace coverage.

  • These data suggest that policies including the American Rescue Plan, new state Medicaid expansions, and the 2021 Marketplace Special Enrollment Period, in addition to the economic recovery, have helped Americans gain insurance coverage during the COVID -19 public health crisis.”

A reduction in Medicare Part B premiums remains in play. Here’s where things stand “More than three months after Health and Human Services Secretary Xavier Becerra ordered a reassessment of this year’s $170.10 standard monthly premium — a bigger-than-expected jump from $148.50 in 2021 — it remains uncertain when a determination will come and whether it would affect what beneficiaries pay this year…
About half of the larger-than-expected 2022 premium increase, set last fall, was attributed to the potential cost of covering Aduhelm — a drug that battles Alzheimer’s disease — despite actuaries not yet knowing the particulars of how it would be covered because Medicare officials were still determining that…
Several weeks ago, CMS officials announced that the program will only cover Aduhelm for beneficiaries who receive it as part of a clinical trial. Additionally, the per-patient price tag that actuaries had used in their calculation last year was cut in half, effective Jan. 1, by manufacturer Biogen — to $28,000 annually from $56,000.”

About hospitals and healthcare systems

 At US Hospitals, a Drug Mix-Up Is Just a Few Keystrokes Away “More than four years ago, Tennessee nurse RaDonda Vaught typed two letters into a hospital’s computerized medication cabinet, selected the wrong drug from the search results, and gave a patient a fatal dose.
Vaught was prosecuted this year in an extremely rare criminal trial for a medical mistake, but the drug mix-up at the center of her case is anything but rare. Computerized cabinets have become nearly ubiquitous in modern health care, and the technological vulnerability that made Vaught’s error possible persists in many U.S. hospitals.”
This KFF report provides suggestions to address this problem.

Ascension posts $884M quarterly loss “St. Louis-based Ascension reported higher expenses in the three months ended March 31 and ended the quarter with a loss, according to financial documents filed April 29. 
The 143-hospital system reported operating revenue of $6.69 billion in the first three months of this year, up from $6.56 billion in the same period of 2021. 
Ascension's operating expenses climbed to $7.34 billion in the first three months of 2022, up from $6.59 billion in the same period a year earlier. The increase was attributed to several factors, including higher salaries, wages and supply expenses.”

IU Health reports $358M net loss as labor expenses climb 25% “Indianapolis-based Indiana University Health reported a net loss of $358.54 million for the first quarter of 2022 as its labor expenses soared, according to its financial results released April 28. The system had a net income of $330.5 million for the same period last year.
IU Health, a 16-hospital system, had $1.93 billion in revenue for the three months ended March 31, a 2.9 percent increase year over year from $1.87 billion. Its largest source of revenue was patient services, which rose 6.6 percent year over year to $1.79 billion for the first quarter of 2022 from $1.68 billion last year.
The system's expenses climbed 16.4 percent, to $1.96 billion, for the first quarter of 2022, compared to $1.68 billion for the same period last year.”

About pharma

 Biotech Stocks Set for More Pain After Worst April in Decades 
”Biotech stocks closed out “their worst April since at least 1997, with the sector having tumbled more than 60% from its February 2021 peak and sinking 19% in April alone…
Jefferies strategist Will Sevush notes that the 2000 tech crash was similarly led by companies at an early stage of development with little to show in the way of revenue. He pointed out that retail traders also spurred the exuberance that drove both sectors to all-time highs.”

Novo Nordisk reaches primary endpoint in phase III of once-weekly insulin “Danish diabetes care giant Novo Nordisk (NOV: N) today announced headline results from the ONWARDS 2 trial, a Phase IIIa, 26-week efficacy and safety treat-to-target trial investigating once-weekly insulin icodec versus insulin degludec in 526 people with type 2 diabetes switching from daily insulin.
The trial achieved its primary endpoint of demonstrating non-inferiority in reducing HbA1c at week 26 with insulin icodec compared to insulin degludec.”
”Basal” insulin may go from being dosed daily to weekly.

About the public’s health

 American Academy of Pediatrics Calls for Elimination of Race-Based Medicine “In a new policy statement, “Eliminating Race-Based Medicine,” pre-published online May 2, 2022, in Pediatrics, the AAP observes that race is a historically derived social construct that has no place as a biologic proxy. Over the years, the medical field has inaccurately applied race correction or race adjustment factors in its work, resulting in differential approaches to disease management and disparate clinical outcomes.” 

Disparities in Health Care in Medicare Advantage by Race, Ethnicity, and Sex “This report presents summary information on the quality of health care reported in 2021 by Medicare Advantage (MA) enrollees nationwide. Two types of quality-of-care data are presented: (1) measures of patient experience [from the HCAPS reports], which describe how well the care that patients receive meets their needs for such things as timely appointments, respectful care, clear communication, and access to information; and (2) measures of clinical care, which describe the extent to which patients receive appropriate screening and treatment for specific health conditions. In 2021, 42 percent of all people with Medicare were enrolled in MA [from the HEDIS reports]…”
Among the findings: ”Racial and ethnic differences were evident more often for the 36 clinical care measures presented in this report than for the patient experience measures…”

About healthcare IT

1.1M health records breached in April: 5 biggest cyberattacks The article has more details.

 As Teladoc shares tumbled after dismal Q1 earnings, analysts question telehealth giant's growth strategy “Shares of Teladoc plunged more than 45% Thursday after the telehealth giant reported disappointing first-quarter results.
The company reported earnings in the first quarter that missed on both the top and bottom lines. Teladoc's revenues grew 25% year over year to $565.4 million, below the $568.9 million that analysts were expecting. Earnings per share came in at a loss of $41.58, well below the loss of 62 cents expected, largely due to a write-down of assets related to its acquisition of Livongo in 2020. The company's sizable net loss included a noncash goodwill impairment charge of $6.6 billion, or a loss of $41.11 per share.” 

About healthcare personnel

 Use of Preventive Care Services Associated with Patient-Provider Sex Concordance in the US 
Key Points:

  • For women, having a female physician was related to greater use of multiple preventive services.

  • Sex concordance was not associated with greater use of preventive care services for men.

  • Men’s use of preventive care services increases with age at a greater rate relative to women. However, use of preventive care services by women is higher than for men to begin with.” 

About health technology

Predicting pancreatic ductal adenocarcinoma using artificial intelligence analysis of pre-diagnostic computed tomography images “A set of 108 retrospective CT scans (36 scans from each healthy control, pre-diagnostic, and diagnostic group) from 72 subjects was used for the study. Model development was performed on 66 multiphase CT scans, whereas external validation was performed on 42 venous-phase CT scans…
The system achieved an average classification accuracy of 86% on the external dataset.”
Use of such AI can identify tumors before thy become symptomatic. The problem is identifying those who need to be screened.

Guardant debuts first cancer screening blood test for catching colorectal tumors “Guardant’s Shield test, meanwhile, is intended for adults over age 45 who have an average risk for colorectal cancer and show no symptoms..
The test searches for early signs of colorectal cancer from pieces of tumor DNA found floating in the bloodstream. In a clinical study of about 300 samples, the assay showed 91% sensitivity in detecting positive cases, including 90% for people with early, stage I cancers, 97% for stage II and 86% for stage III. Shield also demonstrated a low rate of false positives, at 8%, but the company said that a negative result does not fully rule out the presence of cancer.” 

Today's News and Commentary

About Covid-19

Covid deaths no longer overwhelmingly among unvaccinated as toll on elderly grows “Unvaccinated people accounted for the overwhelming majority of deaths in the United States throughout much of the coronavirus pandemic. But that has changed in recent months, according to a Washington Post analysis of state and federal data…
The vaccinated made up 42 percent of fatalities in January and February during the highly contagious omicron variant’s surge, compared with 23 percent of the dead in September, the peak of the delta wave, according to nationwide data from the Centers for Disease Control and Prevention…
As a group, the unvaccinated remain far more vulnerable to the worst consequences of infection — and are far more likely to die — than people who are vaccinated, and they are especially more at risk than people who have received a booster shot.”

 Comparison of Home Antigen Testing With RT-PCR and Viral Culture During the Course of SARS-CoV-2 Infection Findings  In this prospective cohort study of 225 adults and children with reverse transcription–polymerase chain reaction (RT-PCR)–confirmed SARS-CoV-2 infection, antigen test sensitivity was 64% and 84% when compared with same-day RT-PCR and viral culture, respectively. Antigen test sensitivity peaked 4 days after illness onset (77%); a second test 1 to 2 days later showed improved sensitivity (81%-85%).
Meaning  The study results suggest that symptomatic individuals with an initial negative home antigen test result for SARS-CoV-2 infection should test again 1 to 2 days later because test sensitivity seems to peak several days after illness onset.”

Vaccines for young kids could be available in June, FDA official says “The remarks by Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, came in an interview about the agency’s new, but tentative, timeline for handling vaccine issues during the next two months. The FDA announced plans to convene meetings with its outside advisers on June 8, 21 and 22 to consider emergency use authorizations for pediatric coronavirus shots and to hold additional sessions for other pressing vaccine matters.”

About health insurance

 Racial and Ethnic Disparities in Insurance Coverage Among US Adults Aged 60 to 64 Years “…the coverage disparity between low-income Hispanic adults and low-income White adults was 11.4 percentage points larger in [Medicaid] nonexpansion states vs expansion states (95% CI, 3.2-19.5 percentage points; P = .007). We did not detect significant Black-White coverage disparities in expansion or nonexpansion states.”

Doctor Sentenced in $12 Million Medicare Fraud and Device Adulteration Scheme “A California doctor was sentenced today to 93 months in prison for defrauding Medicare, re-packaging single-use catheters for re-use on patients, and submitting false declarations in a bankruptcy proceeding. 
According to court documents, Donald Woo Lee, 55, of Temecula, recruited Medicare beneficiaries to his clinics, falsely diagnosed the beneficiaries, and provided the beneficiaries with medically unnecessary procedures. Lee billed these unnecessary procedures to Medicare using an inappropriate code in order to obtain a higher reimbursement, a practice known as ‘upcoding.’”

UK healthcare is already being privatised, but not in the way you think Among the findings: “In 1990, out-of-pocket spending by Britons on medical expenses was equivalent to 1 per cent of GDP, while across the Atlantic, uninsured Americans forked out more than twice as much, at 2.2 per cent. Thirty years on, that gap has all but disappeared. Americans’ non-reimbursable spending now stands at 1.9 per cent, and Britons’ has doubled to 1.8 per cent.”
The delays in care from the NHS have forced many to seek fee-for-service private care.

Employers to tackle employee healthcare affordability amid rising costs “The vast majority of U.S. employers (94%) say managing healthcare benefit costs will be their top priority over the next two years, followed by enhancing mental health benefits (87%), according to a new survey by WTW (Willis Towers Watson)…
When asked what their greatest challenges will be to effectively deliver on their healthcare strategy over the next two years, 73% cited increasing healthcare prices due to rising inflation and provider consolidation. More than half (54%) identified lack of employee awareness about where to find programs to support their needs as a key challenge.”

About hospitals and healthcare systems

 Association Between Hospital Private Equity Acquisition and Outcomes of Acute Medical Conditions Among Medicare Beneficiaries “In this cross-sectional study of more than 21 million Medicare beneficiaries with 5 different acute medical conditions who were hospitalized at short-term acute care hospitals, PE acquisition was associated with significantly lower inpatient mortality (−1.1 percentage points) and lower 30-day mortality (−1.4 percentage points) among patients admitted with acute myocardial infarction. However, PE acquisition was not associated with significant differences in other dimensions of quality and spending or with differences across other medical conditions.”

19 Tenet hospitals sue Cigna over alleged low reimbursement rates, denied claims “Tenet Healthcare and 19 of its hospitals are accusing Cigna of reimbursing claims at low rates and wrongfully denying claims for emergency care in a lawsuit…
Nineteen hospitals managed by Tenet across Arizona, Florida, Tennessee, Alabama, South Carolina and Massachusetts allege Cigna engaged in ‘an ongoing pattern of financial misconduct.’
The hospitals allege Cigna created ‘narrow’ networks — which Tenet is not part of — to maximize the discounts it receives from the limited number of hospitals participating in those networks, thereby creating the risk of members seeking care at out-of-network emergency departments that have not agreed to offer discounted rates. The lawsuit claims Cigna forced Tenet hospitals to treat members at artificially low rates by reimbursing the hospitals at rates they did not agree to.
The lawsuit also claims Cigna ‘arbitrarily denied numerous claims for emergency medical services.’”

HCA agrees to acquire urgent care chain “Nashville, Tenn.-based HCA Healthcare signed an agreement to acquire Richmond, Va.-based BetterMed, an urgent care practice with 12 locations, Tim McManus, president of HCA Healthcare Capital Division…
The deal is not final, he added. The HCA Healthcare Capital Division has locations in Indiana, Kentucky, New Hampshire and Virginia…”

SSM Health, Saint Louis University Collaborate to Form the Region’s Leading Fully Integrated Healthcare Delivery Network SLU press release: “Under a new agreement reached in principle, the two organizations will formally bring together the world-class academic medical expertise of SLUCare Physician Group with SSM Health’s high-quality community-based care model to create the region’s leading integrated healthcare network. Ownership of SLUCare Physician Group will transition from Saint Louis University to SSM Health when the transaction closes. The agreement is expected to be finalized later this summer, pending all regulatory and other approvals.”

Memorial Sloan Kettering reports operating loss of $13.5M “New York City-based Memorial Sloan Kettering Cancer Center's operating loss narrowed to $13.5 million in the three months ended March 31, compared to a loss of $33 million in the same period last year, according to its financial results released April 25.
The organization, which has locations in New York and New Jersey, reported a total operating revenue of $1.6 billion in the first quarter of 2022, a 10.3 percent increase from the same period last year at $1.5 billion.
Its expenses reached $1.6 billion for the first quarter of 2022, an 8.7 percent increase year over year from $1.5 billion. Its compensation and fringe benefits also rose by 7.2 percent year over year, from $824 million in the first quarter of 2021, to $882.9 million in the first quarter of 2022.”
Keep in mind that MSK is one of the named cancer hospitals exempt from DRGs and often does not negotiate rates with private payers.

About pharma

Ex-Cerebral executive files lawsuit claiming the startup overprescribed ADHD meds “The lawsuit, filed Wednesday in California state court, alleges that Cerebral planned to increase customer retention by prescribing stimulants to 100% of its ADHD patients.”
See the related story in yesterday’s blog about Walmart and CVS blocking prescriptions from this and other similar companies.

 Latest pharma financial reports
Lilly bumps up annual sales guidance as Trulicity revenue climbs 20% in Q1 
Merck & Co. raises annual guidance as COVID-19 drug sales top $3 billion in Q1 
Gilead's Q1 sales edge past estimates lifted by Biktarvy, Veklury
Novo Nordisk hikes full-year forecast after Q1 sales climb 24%
AstraZeneca backs annual guidance as Farxiga sales reach $1 billion in Q1

About the public’s health

 U.S. Case of Human Avian Influenza A(H5) Virus Reported “A person has tested positive for avian influenza A(H5) virus (H5 bird flu) in the U.S., as reported by Colorado and confirmed by CDC. This case occurred in a person who had direct exposure to poultry and was involved in the culling (depopulating) of poultry with presumptive H5N1 bird flu.” 

About healthcare IT

 Walmart Health rolls out virtual diabetes program as retail giant moves deeper into treating chronic conditions “Building on its acquisition of telehealth provider MeMD last year, Walmart Health is rolling out a virtual care diabetes program for employers and payers.”

About health technology

 Baxter's revenue climbs with acquisition of Hillrom “Medical products giant Baxter International reported rising revenue in the first quarter coming on the heels of its acquisition of Hillrom.
Deerfield-based Baxter saw revenue grow 26% to $3.7 billion in the first quarter, the company announced in an earnings call today. U.S. sales totaled $1.76 billion, a nearly 50% increase from the same period a year earlier, with international sales increasing 10% to $1.95 billion. Net income was $71 million.”

Today's News and Commentary

About Covid-19

Moderna seeks authorization of coronavirus vaccine for youngest children “Vaccine maker Moderna requested emergency use authorization Thursday of its coronavirus vaccine for babies, toddlers and youngchildren — a highly anticipated step toward making shots available to the last group in U.S. society lacking access…
The full data supporting the application is expected to be filed by early in the second week of May, according to a senior Biden administration official, who spoke on the condition of anonymity because they were not authorized to discuss the matter publicly.”

AMA announces CPT update for COVID-19 booster candidates “The American Medical Association (AMA) …announced an editorial update to Current Procedural Terminology (CPT®)… for describing health care procedures and services, that includes newly assigned provisional CPT codes for COVID-19 booster candidates from Pfizer and Sanofi-GlaxoSmithKline.
The Pfizer booster candidate is proposed for use in children ages 5 to 11 who have completed a COVID-19 vaccine primary series, while the Sanofi-GSK booster candidate is proposed for use in persons age 18 and older who have completed a COVID-19 vaccine primary series.”

About health insurance

HHS Announces New Policy to Make Coverage More Accessible and Affordable for Millions of Americans in 2023 Some highlights:

The rule:
— “helps simplify the consumer shopping experience by establishing standardized plan options for issuers offering Qualified Health Plans (QHPs) on HealthCare.gov. With standardized maximum out-of-pocket limitations, deductibles, and cost-sharing features, consumers will be able to more directly compare other important plan attributes, such as premiums, provider networks, prescription drug coverage, and quality ratings when choosing a plan…
—requires QHPs on the Federally-facilitated Marketplace (FFM) to ensure that certain classes of providers are available within required time and distance parameters…
—aims to protect consumers from discriminatory practices related to the coverage of the essential health benefits (EHB) by refining the CMS nondiscrimination policy.”

By The Numbers: New AHIP Resource Illustrates How Employer-Provided Coverage Supports Better Health and Financial Stability This article provides state-specific data on employer-sponsored health insurance. Some “big picture” findings:
1. “Nearly half of Black Americans (47%) are enrolled in employer-provided coverage

2. More than 40% of Hispanic Americans are enrolled in employer-provided coverage

3. About two-thirds of Asian Americans and Native Hawaiian and Pacific Islanders are enrolled in employer-provided coverage

4. 50% of children (age 0-18) in the United States receive health coverage through a parent/guardian’s job

5. 60% of those with incomes between 200-399% of the Federal Poverty Line (FPL) — $20,578 for a family of 3 — are enrolled in employer-provided coverage”

The Facts About Medicare Spending From the KFF. “Medicare provides health insurance coverage for 65 million people, nearly 20% of the U.S population – a share which will grow larger in the coming decades. In 2020, Medicare spending comprised 12% of the federal budget and 20% of national health care spending.”
See the monograph for more details.

 Some Medicare Advantage Organization [MAO] Denials of Prior Authorization Requests Raise Concerns About Beneficiary Access to Medically Necessary Care From the HHS OIG:
Key Takeaway
[Some] MAOs denied prior authorization and payment requests that met Medicare coverage rules by:

  • using MAO clinical criteria that are not contained in Medicare coverage rules;

  • requesting unnecessary documentation; and

  • making manual review errors and system errors.

…we recommend that CMS:
(1) issue new guidance on the appropriate use of MAO clinical criteria in medical necessity reviews;
(2) update its audit protocols to address the issues identified in this report, such as MAO use of clinical criteria and/or examining particular service types; and
(3) direct MAOs to take steps to identify and address vulnerabilities that can lead to manual review errors and system errors.
CMS concurred with all three recommendations.”

Urgent Care Doctor and his Facilities Settle Allegations of Federal Health Care Fraud “Breon Peace, United States Attorney for the Eastern District of New York, announced today that Dr. Josef Schenker and two urgent care facilities owned by him, Josef Schenker, M.D., P.C., and Care Partners Medical Management, LLC, have agreed to pay $564,217.70 to resolve allegations that they submitted false claims to Medicare for services not provided in administering COVID-19 vaccines and tests.”

About hospitals and healthcare systems

 CHS posts $1M loss in Q1 after COVID-19 surge as contract labor rates remain high “Hospital chain Community Health Systems posted a $1 million loss for the first quarter of 2022 after experiencing its largest COVID-19 surge to date and continued high rates for contract labor.
CHS generated $3.1 billion in net operating revenues for the first quarter and adjusted earnings before interest, taxes, deductions and amortization (EBITDA) of $409 million, including $47 million in pandemic relief funds. Admissions for the system also declined slightly by 0.3% compared to the same period in 2021…
Overall, CHS’ operating costs and expenses increased to $2.8 billion, slightly above the $2.6 billion it generated in the same period in 2021.”

About pharma

 Amgen vows to fight $7.1B tax bill tied to Puerto Rico manufacturing unit “When Amgen released first-quarter results on Wednesday, its sales and profit numbers were again overshadowed by a bombshell tax disclosure.
Earlier this month, the company received a notice of deficiency from the Internal Revenue Service centered on the 2013 to 2015 period, Amgen said. The agency seeks to increase Amgen's taxable income for the period to an amount that would leave the company with a $5.1 billion bill, plus interest. On top of that, the IRS is proposing penalties of approximately $2 billion.
The notice is similar to the adjustments Amgen received from the IRS for the 2010 to 2012 period. In that case, the IRS handed Amgen a $3.6 billion bill. Amgen vowed to fight that bill as well.”

Association of Quality-of-Life Outcomes in Cancer Drug Trials With Survival Outcomes and Drug Class “This cohort study of 45 RCTs found that a minority (24%) of new medicines were associated with improved QOL. Only 22% of trials showing improved progression-free survival also showed improved QOL, and approximately one-half of trials that failed to show improvement in QOL reported these outcomes positively.”

McKinsey rebuts conflict claims over work for health regulator and opioid makers “ McKinsey’s managing partner has pushed back against allegations that the consultancy breached conflict of interest rules by advising opioids producers on how to “turbocharge” sales while also working for US health regulators seeking to tackle a deadly painkiller overdose epidemic. Bob Sternfels told a US congressional committee on Wednesday that he regretted McKinsey did not act sooner to cut ties with opioid producers and help solve a crisis that has led to more than 500,000 American deaths in a decade. But he rejected the interim findings of a congressional report that suggested the consultancy’s work ‘appears potentially’ to have violated rules for federal contractors that require disclosures of potential conflicts of interest.”

Walmart, CVS Pharmacies Have Blocked or Delayed Telehealth Adderall Prescriptions “Some of the nation’s largest pharmacies have blocked or delayed prescriptions over the last year from clinicians working for telehealth startups that have sprung up to treat attention-deficit hyperactivity disorder, according to pharmacies and people familiar with the issue.
The pharmacies in certain cases have expressed concerns that clinicians at Done Health and Cerebral Inc. are writing too many prescriptions for Adderall and other stimulants, the people said. The federal government considers the drugs controlled substances because of their potential for abuse and places them in the same category as cocaine.”

About the public’s health

In a milestone, FDA proposes ban on menthol cigarettes and flavored cigars “The Food and Drug Administration on Thursday proposed banning menthol cigarettes, a landmark action applauded by leading health and civil rights groups that say the industry has a history of aggressively marketing to Black communities and causing severe harm, including higher rates of smoking-related illness and death.
The FDA also proposed prohibiting flavors in cigars, including in small ones called cigarillos that are popular among teenagers.”

 Which Animal Viruses Could Infect People? Computers Are Racing to Find Out. Interesting article about the use of machine learning to identify threats from animal viruses and trace sources for emerging known infections (like Covid-19).

 Measles cases jump 79% in 2022 after COVID hit vaccination campaigns “ Measles cases jumped by 79% in the first two months of this year compared to 2021, after COVID-19 and lockdowns disrupted child vaccination campaigns around the world, according to data from UNICEF and the World Health Organization (WHO).
In January and February, there were 17,338 measles cases reported worldwide, up from 9,665 in the same period last year.”

Antibiotic Use and Vaccine Antibody Levels Another reason for judicious use of antibiotics:
”Antibiotic use in children <2 years of age is associated with lower vaccine-induced antibody levels to several vaccines.”

About healthcare IT

Teladoc slashes earnings outlook, takes $6.6B impairment charge on Livongo deal “In its first-quarter 2022 earnings press release (PDF), the company reported losses in the first quarter of 2022 ballooned to $6.7 million, or a loss of $41.58 per share, compared to $199.6 million, or a loss of $1.31 per share, in the first quarter of 2021. 
The company recorded a ‘non-cash goodwill impairment charge,’ which does not impact the company's cash or liquidity.  Companies opt for impairment when the value of assets or goodwill on their books is no longer fully recoverable. 
Teladoc shares plummeted 33% after-hours Wednesday.
Teladoc completed its massive $18.5 billion acquisition of digital chronic condition management company Livongo in October 2020…”

About health technology

 OIG Approves Physician-Owned Medical Device Company “On April 25, 2022, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued a favorable Advisory Opinion regarding a medical device company (Company) in which physicians who order the Company’s products hold a majority ownership interest. The Company manufactures medical device products that may be ordered by the physician owners and a physician spouse of one of the physician owners.”
The Advisory Opinion is specific to this circumstance but may have broader application.

About healthcare finance

 Healthcare M&A slowed in Q1, but investment in IT, telehealth is expected to remain hot “The pace of healthcare and life sciences mergers and acquisitions has slowed, according to KPMG’s latest report
The report, which examines the dealmaking pace for the first quarter of 2022, found this quarter’s deal volume has declined by 34% to 427 deals compared to the fourth quarter of 2021. Private equity has pulled back the most, making 50% fewer deals.”

Today's News and Commentary

About Covid-19

Pfizer, BioNTech ask FDA to allow Comirnaty boosters in kids 5 through 11 “Pfizer and BioNTech said Tuesday that they asked the FDA to allow a third 10µg dose of their COVID-19 vaccine Comirnaty to be given to children ages 5 through 11 under an emergency-use authorisation (EUA). The companies also plan to seek authorisations to permit Comirnaty boosters in this group "in the coming weeks" from the European Medicines Agency and other global regulatory bodies.”

Vice President Harris tests positive for the coronavirus “Vice President Harris has tested positive for the coronavirus, the White House said Tuesday, becoming the most senior Biden administration official to contract a virus that has afflicted millions of Americans.
Harris tested positive on both rapid and PCR tests but has exhibited no symptoms, said Harris’s press secretary, Kirsten Allen.”
She had been vaccinated and “boosted.” The VP will be isolated and has started on Paxlovid.

Cerner, Epic collaborate with White House on COVID-19 therapeutics “The White House announced in an April 26 press release that it is calling on EHR vendors to incorporate information about oral antivirals directly into their health records interface. 
Cerner and Epic reinforced their commitment to connecting clinicians and patients with correct information about COVID-19 treatments and is rolling out enhancements to its systems to support the White House's efforts.”
Read the article for specifics of EHR enhancements.

Longer intervals between COVID-19 vaccine doses produce higher antibody levels “A longer period between doses also was associated with higher antibody levels — up to nine times higher [2 to 4 weeks = 1,268.72 (95% CI, 1,043.25-1,542.91); more than 10 weeks = 11,479.73 (95% CI, 10,742-12,267.24)].”

About health insurance

CMS Plans to Reweight 2021 MIPS Cost Performance Category “CMS will reweight the cost performance category under the Merit-Based Incentive Payment System (MIPS) for the 2021 performance period due to the COVID-19 pandemic’s impact on clinicians and cost measures…
The cost performance category weight will change from 20 percent to 0 percent. The 20 percent will be redistributed to other performance categories, including the quality performance category, improvement activities performance category, and promoting interoperability performance category.”

 Humana's Q1 profit jumps 12% year over year to $930M “Humana reported $930 million in profit for the first quarter of 2022, up 12.3% year over year from an $828 million haul in the first quarter of 2021.
Revenues were also up by double digits from the prior-year quarter, hitting $24 billion, the company reported Wednesday. That's a 16% hike from the first quarter of 2021, when the insurer earned $20.7 billion in revenue.”

Pharmacist Sentenced for $180 Million Health Care Fraud Scheme “A former Mississippi pharmacist was sentenced today to 10 years in the Southern District of Mississippi for a multimillion-dollar scheme to defraud TRICARE and private insurance companies by paying kickbacks to distributors for the referral of medically unnecessary prescriptions. The conduct resulted in more than $180 million in fraudulent billings, including more than $50 million paid by federal health care programs. 
According to court documents, Mitchell ‘Chad’ Barrett, 55, now of Gulf Breeze, Florida, and formerly of Mississippi, participated in a scheme to defraud TRICARE and other health care benefit programs by distributing medically unnecessary compounded medications.”

About pharma

 Arizona Passes Goldwater Institute’s Right to Try Law “Arizona has become the 41st state to enact a ‘right-to-try’ law that allows patients to access drugs that are still in clinical trials without asking the FDA for permission under the agency’s expanded access program.”
The exact  terms of these laws vary by state. For example, in Illinois one of the qualifying criteria is that a patient “has a terminal illness.”

About the public’s health

 1 death, 17 liver transplants in multi-country outbreak of hepatitis in children, WHO says  “At least 169 cases of acute hepatitis in children aged one month to 16 years old have been identified in an outbreak that now involves 11 countries, the World Health Organization (WHO) said on Saturday. 
Among the cases of acute hepatitis, at least one child has died and 17 children have required liver transplants, the WHO said in a news release…
’While adenovirus is a possible hypothesis, investigations are ongoing for the causative agent.’”

FDA Issues Marketing Decisions on NJOY Ace E-Cigarette Products “On April 26, the FDA issued decisions on multiple NJOY Ace e-cigarette products, including the authorization of four new tobacco products through the Premarket Tobacco Product Application (PMTA) pathway. The FDA issued marketing granted orders to NJOY LLC for its Ace closed e-cigarette device and three accompanying tobacco-flavored e-liquid pods, specifically: 

  • NJOY Ace Device

  • NJOY Ace Pod Classic Tobacco 2.4%

  • NJOY Ace Pod Classic Tobacco 5%

  • NJOY Ace Pod Rich Tobacco 5%

This authorization allows these products to be legally marketed in the U.S. While this action permits these specific products to be sold in the U.S., it does not mean these products are safe nor are they ‘FDA approved.’ All tobacco products are harmful and potentially addictive. Those who do not use tobacco products shouldn’t start.”

About healthcare IT

 FBI chief says espionage threat posed by China ‘unprecedented in history’  “‘The biggest threat we face as a country from a counterintelligence perspective is from the People’s Republic of China and especially the Chinese Communist Party,’ Wray said during an interview on CBS News’s ‘60 Minutes.’
‘They are targeting our innovation, our trade secrets, our intellectual property, on a scale that’s unprecedented in history,’ he added, noting that China’s hacking program is larger ‘than that of every other major nation combined.’”

Fiscal Considerations for the Future of Telehealth “When thinking about the long-term direction for telehealth authorities, we suggest attention to the following challenges related to the federal budget, and to national health expenditures.
Utilization – telehealth services should ideally help reduce over-utilization of care, but could end up substantially increasing patient utilization of health care services.
Provider incentives – telehealth services should ideally help providers reduce the cost of care, but payment incentives might lead to more costly care – especially if telehealth services continue to be reimbursed at parity with in-person care.
Fraud and abuse – telehealth services are at particular risk for fraudulent billing.”
For example: “Since telehealth's entrance into the health care market, overall recoveries in health care fraud have doubled from $2.6 billion in FY 2019 to over $5 billion in FY 2021.”

Outcomes of In-Person and Telehealth Ambulatory Encounters During COVID-19 Within a Large Commercially Insured Cohort “In this cohort study of 40.7 million commercially insured adults, telehealth accounted for a large share of ambulatory encounters at the peak of the pandemic and remained prevalent after infection rates subsided. Telehealth encounters for chronic conditions had similar rates of follow-up to in-person encounters for these conditions, whereas telehealth encounters for acute conditions seemed to be more likely than in-person encounters to require follow-up. These findings suggest a direction for future work and are relevant to policy makers, payers, and practitioners as they manage the use of telehealth during the COVID-19 pandemic and afterward.”
The study examined what happened once patients had a telehealth visit. It did not measure how many extra visits may have occurred because of easier access.

About health technology

 Mount Sinai spinout developed algorithm that accurately diagnoses early-stage Parkinson's, per new study “The research, in a collaboration with the Michael J. Fox Foundation for Parkinson’s Research, used technology developed by a Mount Sinai spinout focused on cancer diagnostics. The study leveraged PreciseDx’s algorithms to detect a protein in salivary glands, which is linked to the disease. It was able to detect Parkinson’s with 99% sensitivity and 99% specificity and was more accurate than human pathologists in predicting the disease.”

FDA: Medtronic Issues Recall of Harmony Delivery Catheter “Medtronic is recalling the Harmony Delivery Catheter because it is possible that the bond holding the capsule at the end of the delivery catheter may break during a procedure to place the TPV [Transcatheter Pulmonary Valve System].”

Boston Scientific surges 10% in Q1 amid slew of FDA nods, company reorganization “The medtech's net sales jumped 10% over its performance during the same period last year. The total reached just past the $3 billion threshold, compared to the $2.75 billion it earned in the first three months of 2021.
The jump came even though its earnings sheet for the quarter was short one division compared to the previous year’s. The disparity comes from the sale of Boston Scientific’s BTG specialty pharmaceuticals division, which was completed in March 2021. Until that point, BTG added $13 million that quarter that wasn’t present this time around.”

About healthcare finance

 Biofourmis banks $300M megaround to fuel its growth in remote care, potential M&A deal “Three years ago, technology startup Biofourmis had raised $10 million in total funding. This week, the virtual care and digital medicine-focused company announced a massive $300 million cash injection to fuel its growth.
The funding round has boosted Biofourmis' valuation to more than $1 billion, according to executives…
The Boston-based digital therapeutics company combines AI-based data analytics and biosensors to monitor the progress of medical treatment.”

Today's News and Commentary

About Covid-19

 Coronavirus has infected majority of Americans “Before omicron, one-third of Americans had been infected with the coronavirus, but by the end of February, that rate had climbed to nearly 60 percent — including about 75 percent of kids and 60 percent of people age 18 to 49, according to federal health data released Tuesday.”

Know your variants: A coronavirus 'cheat sheet' A good summary of the topic.

Abbott Makes $3.3B on COVID-19 Tests in First Quarter of 2022 “Abbott said it earned $3.3 billion in global COVID-19 testing-related sales in the first quarter, an increase of more than 57 percent over the same period last year, led by sales of its rapid testing products.
But the company expects that windfall to come to an end in the coming months, with its projection for the entire year set at $4.5 billion — and most of that in the first half.”

Covid-19 data reporting is becoming less frequent, making trends harder to track “Many states are scaling back on how often they report key Covid-19 statistics, a shift that some experts worry might hinder efforts to mitigate outbreaks and negative effects of the coronavirus.
A year ago, all 50 states were reporting new Covid-19 cases on a daily basis. But that has gradually trailed off. This week, Pennsylvania will be the latest state to switch from daily to weekly updates, leaving just six states that will still be reporting new Covid-19 cases every day of the week.”

About health insurance

 HHS to appeal Texas ruling that struck down key parts of surprise billing rule “The Biden administration has filed an appeal to a ruling that vacated key parts of a rule that bans surprise medical bills. 
The Department of Health and Human Services announced in a legal filing late Friday that it is appealing the ruling to the U.S. Court of Appeals for the Fifth Circuit. The decision to appeal the ruling originally issued back in February comes as HHS has other legal fights over the regulation.”

UnitedHealth Aims To Sell Change Healthcare’s $2.2B Claims Editing Service “UnitedHealth Group will sell Change Healthcare’s CHNG.O claims editing business for $2.2 billion to private equity firm TPG Capital if regulators approve a proposed merger between the two health companies.
Change Healthcare disclosed the plan in a filing made to the Securities and Exchange Commission Friday. UnitedHealth Group declined to comment and Change Healthcare didn’t immediately respond to an interview request.”

Illinois expands Medicaid to more noncitizens, midwives “The Illinois General Assembly has passed legislation that expands Medicaid coverage to midwife services and to noncitizen residents ages 42 and older.
Medicaid coverage of licensed midwife services will begin Jan. 1, 2023.
Illinois expanded Medicaid coverage to noncitizens 65 and older in 2020, becoming the first state to do so, according to the State-Journal Register.. On July 1, the age will decrease to 42.”

About hospitals and healthcare systems

 UHS improves on revenue, dips on profits in Q1 2022 “UHS reported $153.9 million in net income for the quarter, down from the $209.1 million it logged during the same period last year. However, net revenues grew year over year from $3 billion to nearly $3.3 billion.”

A systematic review of the prediction of hospital length of stay [LoS]: Towards a unified framework Despite the continuing efforts to predict and reduce the LoS of patients, current research in this domain remains ad-hoc; as such, the model tuning and data preprocessing steps are too specific and result in a large proportion of the current prediction mechanisms being restricted to the hospital that they were employed in. Adopting a unified framework for the prediction of LoS could yield a more reliable estimate of the LoS as a unified framework enables the direct comparison of length of stay methods.

Massive Growth in Expenses and Rising Inflation Fuel Continued Financial Challenges for America’s Hospitals and Health Systems An analysis from the AHA provides background on cost increases in drugs, labor and supplies, as well as the impact of inflation.

About pharma

 FDA plans study into how patients and physicians make prescription decisions “he FDA’s Office of Prescription Drug Promotion (OPDP) wants to find out how patients and physicians weigh the trade-offs between risks and benefits when starting a new prescription drug. What characteristics influence treatment choices and how do people reach the decision for one drug over another? The OPDP will be answering these questions through a new study (PDF).
The study will focus on Type 2 diabetes and psoriasis, splitting 800 patients and 800 physicians who have or specialize in those diseases to compare the preferences of the two groups. Participants will be asked to make specific choices based on profiles of fake prescription drugs in a process that will take 20 minutes.”

Novartis backs full-year outlook as Q1 growth led by Entresto Details by drug are provided.

About the public’s health

 Aspirin Use to Prevent Cardiovascular Disease: Preventive Medication  “The USPSTF recommends against initiating low-dose aspirin use for the primary prevention of CVD in adults 60 years or older.” 

Judge Says Migrants Must Still Be Denied Entry for Health Reasons “The federal government has announced plans to lift the order, known as Title 42, on May 23 — a move that is expected to create a considerable surge of migration from Mexico. Several states have challenged the plan, saying it will create chaos on the border and lead to significant impacts on states forced to handle the newly arriving migrants.
Judge Robert R. Summerhays of the United States District Court for the Western District of Louisiana did not yet rule on the issue of whether Title 42, adopted early in the coronavirus pandemic, should be kept in place. But he said he would in the meantime grant a request from the states of Missouri, Louisiana and Arizona to prevent the federal government from taking any early steps to disregard Title 42 for certain migrants and process them under normal immigration procedures.”

About healthcare IT

 EHR vendors ranked by ​​percentage of hospital market share FYI

 US agency unveils framework to evaluate health apps “The Defense Health Agency's branch for connected health developed a framework to evaluate the thousands of health apps available. 
The framework, called the App Rating Inventory, was created to support clinical decisions regarding app selection, according to a study published April 15 in the Journal of Medical Internet Research.
The App Rating Inventory produces scores for three categories: evidence, content and customizability. The evidence category is based on six measures, and the content and customizability categories are based on 11 measures each. All 28 measures are weighted equally.”

About healthcare personnel

 PAI-Avalere Health Report on Trends in Physician Employment and Acquisitions of Medical Practices: 2019-2021 “Key Findings:

Nearly 3 of 4 physicians are now employed by hospitals, health systems and other corporate entities such as private equity firms and health insurers.      

  • More than one hundred thousand (108,700) physicians shifted to employment since January 2019. This growth split nearly evenly between hospital employees (58,200 additional physician employees) and other corporate entities (50,500 additional physician employees).

  • Of those, 83,000 physicians (76%) became employees since the pandemic began.

  • 2021 alone saw a marked increase in employed physicians, growing by 19%, from 69.3% to 73.9% of all physicians…

  • Hospitals and corporate entities, including private equity firms and insurance companies, now own over half (52.1%) of physician practices (hospitals own 26.4% and other corporate entities own 27.2%).

  • While hospital and health system acquisitions continued at a steady pace (9% growth), the sharpest increase (86% growth) in medical practice acquisitions over the three-year study period was by corporate entities.

  • The COVID-19 pandemic accelerated corporate ownership of physician practices and physician employment by hospital systems and other corporate entities in the last half of 2020 and throughout 2021.

  • Every region of the country saw a steady trend towards increased employment and hospital and corporate ownership of practices, but there are distinct differences among regions.

    • The South saw the highest rate of acquisitions by corporate entities (94% increase).

    • The Midwest continued to have the highest percentage of physicians employed by hospitals and health systems (63.5%, growing 9% over the study period).”

About health technology

 Philips Subpoenaed by DOJ Over Sleep-Apnea Device Recall “Royal Philips NV has been subpoenaed by the Justice Department in relation to a sprawling and costly recall of breathing-aid devices affecting millions of sleep-apnea patients.
The Dutch healthcare conglomerate is amid a huge recall over concerns that a type of foam used in certain breathing-aid devices could degrade and release harmful, possibly cancer-causing particles. Philips said its Respironics division and some other subsidiaries received the subpoena on April 8 to ‘provide information relating to events leading to the Respironics recall.’ It said it was cooperating with the agency.”

Today's News and Commentary

About Covid-19

Coronavirus (COVID-19) Update: FDA Approves First COVID-19 Treatment for Young Children “Today, the U.S. Food and Drug Administration expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with positive results of direct SARS-CoV-2 viral testing, who are:

  • Hospitalized, or

  • Not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.

This action makes Veklury the first approved COVID-19 treatment for children less than 12 years of age. As a result of today’s approval action, the agency also revoked the emergency use authorization for Veklury that previously covered this pediatric population.”

Oral Antiviral Medications for COVID-19 A good, easy to understand review of the topic

 Biden admin to promote availability of COVID antiviral pill “First approved in December, supply of the Pfizer regimen was initially very limited, but as COVID-19 cases across the country have fallen and manufacturing has increased it is now far more abundant. The White House is now moving to raise awareness of the pill and taking steps to make it easier to access. 
Paxlovid, when administered within five days of symptoms appearing, has been proven to bring about 90% reduction in hospitalizations and deaths among patients most likely to get severe disease…
The U.S. has ordered enough supply of the pills for 20 million people, which is estimated to last for several more months. The administration has warned that subsequent deliveries are dependent on Congress approving additional COVID-19 response funding.”
In a related story: WHO recommends highly successful COVID-19 therapy and calls for wide geographical distribution and transparency from originator “WHO made a strong recommendation for nirmatrelvir and ritonavir, sold under the name Paxlovid, for mild and moderate COVID-19 patients at highest risk of hospital admission, calling it the best therapeutic choice for high-risk patients to date. However, availability, lack of price transparency in bilateral deals made by the producer, and the need for prompt and accurate testing before administering it, are turning this life-saving medicine into a major challenge for low- and middle-income countries.” 

Quarter of US COVID-19 deaths could have been prevented by vaccination: analysis “The analysis from the Peterson Center on Healthcare and the Kaiser Family Foundation underscores the importance of vaccination, and indicates a significant portion of the heavy toll from the virus could have been prevented.  
The 234,000 preventable deaths translates to about one quarter of the nearly 1 million U.S. deaths from the virus since the pandemic began, and 60 percent of the deaths since June 2021, when vaccines became widely available.”

COVID-19 third leading cause of death for 2nd year straight: 4 updates “About 415,000 Americans died of COVID-19 in 2021, making it the third leading cause of death in the U.S. for the second consecutive year, according to provisional data from the CDC. 
The two leading causes of deaths last year were heart disease and cancer, respectively, with provisional death tolls of about 693,000 and 605,000, respectively, according to the data published April 22. 

About health insurance

 Biden administration says it won’t keep messing with Texas' Trump-era Medicaid waiver “The Biden administration is dropping out of litigation against a Texas Medicaid waiver that the Trump administration approved during its final week in office, saying the yearlong court fight has overtaxed the federal government’s resources.
Last spring, the Centers for Medicare and Medicaid Services revoked a 10-year waiver for Texas’ Medicaid program that the Trump administration approved on Jan. 15, 2021, without going through a required public comment period. The provision, which extended the state’s waiver for a decade, included significant money for health providers to cover the cost of caring for uninsured patients. Texas sued the Biden administration, and in August a federal district court judge reinstated the waiver. With CMS’ decision not to challenge that judge’s ruling, the provision will continue through 2030.”

CMS Proposes Updates to Reduce Barriers to Coverage, Simplify Medicare Enrollment and Expand Access “CMS) issued a proposed rule to update Medicare enrollment and eligibility rules that would expand coverage for people with Medicare and advance health equity. This proposed rule would provide Medicare coverage the month immediately after enrollment, thereby reducing the uninsured period and expand access through Medicare special enrollment periods (SEPs). It would also allow eligible beneficiaries to receive Medicare Part B coverage without a late enrollment penalty. This proposed rule would make it easier for people to enroll in Medicare and eliminate delays in coverage.”

About pharma

The top advertisers in Big Pharma FYI. The list is by drug.

 Pfizer recalls some batches of blood pressure drug over carcinogen presence “Pfizer said on Friday it was voluntarily recalling five batches of its Accupril blood pressure tablets after finding elevated levels of a potential cancer-causing agent in the medicine.
The drugmaker said it was not aware of any reports of adverse events related to the recalled batches, which were distributed in the United States and Puerto Rico from December 2019 to April 2022.”
This problem has recently occurred with a number of other medications.

British Regulatory Watchdog Lambasts Seven Pharmaceutical Companies for Code of Practice Breaches “The UK’s self-regulatory industry watchdog, the Association of the British Pharmaceutical Industry (ABPI) has cited seven drugmakers for violations of its code of practice — LEO Pharma, Janssen, Teva Pharmaceuticals, Lundbeck, Otsuka Europe, Daiichi-Sankyo and Roche.
LEO Pharma, for example, was dinged for promoting its psoriasis drug Enstilar (betamethasone dipropionate/calcipotriol monohydrate) before it was given marketing authorization and for its failure to disclose payments made to patient organizations in 2019.”

About the public’s health

 HHS Launches Pledge Initiative to Mobilize Health Care Sector to Reduce Emissions “The voluntary pledge asks signees to, at a minimum, commit to: (1) reducing their organization’s emissions (by 50% by 2030 and to net zero by 2050) and publicly reporting on their progress; (2) completing an inventory of Scope 3 (supply chain) emissions; and (3) developing climate resilience plans for their facilities and communities. It also asks them to designate an executive lead for this work. 

Showa Group Receives FDA’s 510(k) Approval for Biodegradable Nitrile Glove “Fayette, Ala.-based Showa Group’s single-use nitrile gloves have been granted the FDA’s 510(k) marketing clearance.
The company claims to be the only U.S. domestic manufacturer of FDA-cleared, Berry Amendment-compliant medical gloves. The Berry Amendment requires the Department of Defense to give preference in procurement to domestically manufactured products.”

About healthcare IT

 SAS and Microsoft Drive Toward Health Care Interoperability “Global analytics leader SAS and Microsoft are working together to build deep technology integrations, making advanced health analytics more accessible to health care and life science organizations. The collaboration boosts health care interoperability by enabling the use of Fast Healthcare Interoperability Resources (FHIR®) standards and through integration from Azure Health Data Services to SAS® Health on Azure. 
Microsoft recently announced the availability of Azure Health Data Services, a platform as a service (PaaS) offering designed to support Protected Health Information (PHI) in the cloud. By connecting to Azure Health Data Services, the embedded AI capabilities of SAS Health are more efficient and secure, expanding the possibilities of patient-centric innovation and trusted collaboration across the health landscape.”

About health technology

 Labcorp beefs up at-home testing options with Getlabs’ on-demand blood draw service  “Only a few months after launching its Labcorp OnDemand direct-to-consumer testing service, allowing individuals to order tests straight to their doorsteps, the diagnostics giant has inked a deal with Getlabs allowing them to schedule their own sample collection services, too.
Getlabs offers a staff of full-time phlebotomists who are authorized to collect blood, saliva, stool, urine and breath samples. Patients can book a sample collection appointment online, arranging for the Getlabs staffer to meet them at either their home or workplace. Prices start at $25.”

Today's News and Commentary

About Covid-19

CDC panel skeptical of fourth Covid shots for broader population, says U.S. needs clear vaccine strategy “The CDC’s panel of independent vaccine experts signaled an unwillingness to endorse fourth Covid shots for the broader U.S. population until the agency adopts a clear strategy.
The group, in a five-hour meeting Wednesday, largely agreed that repeatedly deploying boosters to prevent infection isn’t a realistic goal with the current generation of shots.”

 Philly ends mask mandate and nixes response levels; Kenney said SEPTA’s move influenced the decision “Mayor Jim Kenney said the decision to scrap the mandate after just a few days was influenced in part by SEPTA’s announcement on Monday that masks would no longer be required on public transit.
SEPTA lifted its mandate shortly after a federal judge in Florida struck down the CDC’s rule requiring masks on most forms of transit.”

About health insurance

 Dozens of Hospitals Sue HHS Over Medicare Billing “On Wednesday a case was filed in the Central District of California by the Cleveland Clinic, Paradise Valley Hospital, and over 125 other hospitals against Xavier Becerra as Secretary of Health and Human Services. The case is regarding the calculation of payments owed under Medicare Part A bills and the Disproportionate Share Hospital (DSH) payment adjustment.
The complaint explained that one of the factors included in the DSH payment adjustment calculation is the number of ‘days entitled to benefits under part A.’
This particular factor comes into play on the “denominator” side of the calculation and on the “numerator” side of the calculation of the disproportionate patient percentage . However, the plaintiffs in the case accuse HHS and Medicare of using different definitions for ‘entitled’ depending on which side of the fraction is being reviewed, resulting in a lower payment to the hospital than would otherwise be calculated.”

KLAS: Hospitals say price transparency remains too confusing and pricey to implement “KLAS spoke with 66 revenue cycle leaders to get a sense of how hospitals feel about the shift towards price transparency and the nuts and bolts of implementing the rule more than a year after its compliance deadline…
Among those surveyed, 52% said that the rule requires a significant number of resources to comply while 40% put resource requirements at a moderate level and 8% at a small number. 
Many of the respondents lashed out at two parts of the rule: the requirement that facilities use machine-readable files for the pricing information and that they put online a master list of rates. 
Respondents cited problems with ‘software used to publish the pricing information. Some say the published rates mainly benefit payer and provider organizations instead of patients.’”

About hospitals and healthcare systems

Rural hospitals have been particularly challenged during the Covid-19 pandemic. Below are two papers explaining the problems they face:
Pandemic Increases Pressure on Rural Hospitals & Communities and
THE IMPACT OF THE PANDEMIC ON RURAL HOSPITALS

 HCA's profit dips to $1.2B as labor costs rise “The 182-hospital system reported revenues of $14.95 billion in the first quarter of this year, up from $13.98 billion in the same period of 2021. The for-profit hospital operator said same-facility admissions, emergency room visits and inpatient and outpatient surgeries increased year over year. 
HCA reported higher expenses. Salaries and benefits climbed 10.1 percent year over year to $6.94 billion. Supplies expenses were $2.32 billion, up 4.4 percent from the same quarter of 2021. “

About pharma

Spending on U.S. Medicines Rose 12% in 2021 Due to COVID-19 Vaccines and Therapies, Says IQVIA Institute for Human Data Science “Spending on medicines in the United States, at estimated net manufacturer prices, reached $407 billion in 2021, up 12% over 2020, as COVID-19 vaccines and therapeutics became widely available and added $29 billion in related spending…In the same year, the non-COVID medicines market grew more slowly, at 5%, from the growing impact of biosimilars, which increased significantly, offsetting increased use of branded medicines. 
Patient out-of-pocket (OOP) costs in aggregate rose $4 billion, or 5.3%, in 2021 to a total of $79 billion, back to the level seen in 2018 after two years of declining costs. Those OOP costs remain a significant burden for a relatively small part of the population, even as average costs per prescription were flat or slightly declining.”

 As US launch falters, Biogen ditches Aduhelm application in Europe “Biogen has scrapped its filing for the Alzheimer’s disease drug in the European Union after talks with regulators made it clear the data provided so far are unlikely to support marketing approval, the company said Friday.”

About the public’s health

What's the State of YOUR Air? Annual American Lung Association report on air quality, by county. Enter your zip code to get local information.

Study finds disparities in improper antibiotic prescribing “The analysis found that 11.3% of visits included a prescription for an oral antibiotic, with patients under 18 years (114.1 prescriptions per 1,000 patient visits), Black patients (122.2/1,000 patient visits), Hispanics (138.6/1,000 patient visits), and women (169.6/1,000 patient visits) having the highest antibiotic prescribing rates.
When the researchers broke down the data on inappropriate prescribing, they found that nearly three quarters of the antibiotic prescriptions (73.9%) written for patients 65 and older were inappropriate. They also found high rates of inappropriate antibiotic prescribing for Black patients (63.8%), Hispanic patients (57.5%), and men (57.7%).
The most common reasons for inappropriate antibiotic prescriptions were non-bacterial skin conditions, viral respiratory tract infections, and bronchitis.”

 Effects of mango and mint pod-based e-cigarette aerosol inhalation on inflammatory states of the brain, lung, heart, and colon in mice  “Our findings suggest that daily e-cigarette use may cause neuroinflammation, which may contribute to behavioral changes and mood disorders. In addition, e-cigarette use may cause gut inflammation, which has been tied to poor systemic health, and cardiac inflammation, which leads to cardiovascular disease.” 

Hormone Therapy for the Primary Prevention of Chronic Conditions in Postmenopausal Persons New draft recommendation: “The USPSTF recommends against the use of combined estrogen and progestin for the primary prevention of chronic conditions in postmenopausal persons.” and
”The USPSTF recommends against the use of estrogen alone for the primary prevention of chronic conditions in postmenopausal persons who have had a hysterectomy.”
This document is available for Public Comments until May 16, 2022.

How Discrimination in Health Care Affects Older Americans, and What Health Systems and Providers Can Do From The Commonwealth Fund:
Highlights

  • “Older adults in the United States are more likely to report racial and ethnic discrimination in the health system exists, compared with their peers in 10 other high-income countries.

  • In the U.S., one in four Black and Latinx/Hispanic adults age 60 and older reported that they have been treated unfairly or have felt that their health concerns were not taken seriously by health professionals because of their racial or ethnic background.

  • More than a quarter of U.S. older adults said they did not get the care or treatment they felt they needed because of discrimination.

  • U.S. older adults who have experienced discrimination in a health care setting were more likely to have worse health status, face economic hardships, and be more dissatisfied with their care than those who did not experience discrimination.”

About healthcare IT

 RCM company suffers 3rd-largest health data breach of 2022 “Adaptive Health Integrations, a Williston, N.D.-based company providing healthcare billing services, suffered a breach in October that exposed510,574 individuals' data.
The incident is the third-largest healthcare data breach to occur in 2022, according to HHS' reporting portal.”

Physician Indicted in $10 Million Telemedicine Health Care Fraud Scheme “According to the indictment, Dr. Raffai purported to practice telemedicine with the AffordADoc Network and other telemedicine companies that paid the defendant for each consultation with a beneficiary. Between July 2016 and June 2017, Dr. Raffai allegedly participated in a health care fraud scheme in which he signed prescriptions and order forms via purported telemedicine services for durable medical equipment (DME), including orthotic braces, that were not medically necessary. Dr. Raffai caused the submission of these claims based solely on a short telephone conversation for beneficiaries he had not physically examined and evaluated, and that were induced, in part, by the payments of bribes and kickbacks. Dr. Raffai was paid by telemedicine companies approximately $25 or $30 per patient consultation. The indictment further alleges that Dr. Raffai, together with others, submitted or caused the submission of approximately $10 million in false and fraudulent claims to Medicare for DME on behalf of beneficiaries who were residents of the Eastern District of New York, and Medicare paid more than $4 million on those claims.”

About healthcare personnel

 PAI-Avalere Health Report on Trends in Physician Employment and Acquisitions of Medical Practices: 2019-2021  Key Findings:

“Nearly 3 of 4 physicians are now employed by hospitals, health systems and other corporate entities such as private equity firms and health insurers.      

  • More than one hundred thousand (108,700) physicians shifted to employment since January 2019. This growth split nearly evenly between hospital employees (58,200 additional physician employees) and other corporate entities (50,500 additional physician employees).

  • Of those, 83,000 physicians (76%) became employees since the pandemic began.

  • 2021 alone saw a marked increase in employed physicians, growing by 19%, from 69.3% to 73.9% of all physicians.”

About health technology

 Intuitive Surgical pulls off 15% revenue growth despite ongoing COVID, supply chain challenges “…Intuitive Surgical was able to kick off the year with a modest win, putting up first-quarter revenues of $1.49 billion—a 15% jump compared to the $1.29 billion it earned in the same period of last year, but a minor slip from the $1.55 billion it raked in during the prior quarter, the final three months of 2021.
The year-over-year growth stemmed from a 19% surge in the number of procedures performed around the world using Intuitive’s da Vinci robotic surgery system. Those additional uses were led by ‘bariatric procedures, cholecystectomy, hernia repair and rectal surgery”’in the U.S., CEO Gary Guthart said during a call with investors on Thursday.”

Today's News and Commentary

About Covid-19

 Moderna to file for EUA of COVID-19 shot for very young kids by April end “Moderna plans to submit an application to the U.S. health regulator for emergency use authorization (EUA) of its COVID-19 vaccine among kids between the ages of six months to five years by end of the month, a company spokesperson said on Wednesday.”

Most People Under 50 Don’t Need 4th Shot Yet, CDC Panel Suggests  “Most Americans under 50 should wait for the next generation of booster shots rather than getting a fourth dose now to prevent Covid-19 infections, according to several members of a panel of advisers to the U.S. Centers for Disease Control and Prevention.
The goal of booster shots should be to limit severe outcomes rather than to prevent transmission of the virus, the advisers said in a meeting Wednesday. That means people with high risk of grave illness from an infection should consider an extra shot, but most people should hold out for better vaccines later this year, they said.”

Justice Department Announces Nationwide Coordinated Law Enforcement Action to Combat Health Care Related COVID-19 Fraud “The Department of Justice today announced criminal charges against 21 defendants in nine federal districts across the United States for their alleged participation in various health care related fraud schemes that exploited the COVID-19 pandemic. These cases allegedly resulted in over $149 million in COVID-19-related false billings to federal programs and theft from federally-funded pandemic assistance programs. In connection with the enforcement action, the department seized over $8 million in cash and other fraud proceeds.”

After rejecting COVID rule, Arizona could lose oversight of workplace safety “The U.S. Occupational Safety and Health Administration on Wednesday moved to revoke Arizona's ability to police workplace safety within the state after it refused to adopt a federal rule requiring COVID-19 protections for healthcare workers.”
OSHA has also warned Utah, South Carolina.

COVID-19 tracker: UK study finds strong responses 84 days after booster shot “A U.K.-wide study found prolonged ‘strong immune responses’ 84 days after participants received a booster COVID-19 shot. The study, led by the University Hospital Southampton (UHS) and published in the Journal of Infection, tested immune responses after seven different vaccines used as a boosters 28 days after receiving two doses of AstraZeneca or Pfizer vaccines. While different initial vaccines yielded different results from the booster, “the rate that immune cell responses declined after third doses was similar between all the vaccine combinations and doses,” according to a UHS spokeswoman…”

Novavax touts early data for flu-COVID combo vaccine as FDA decision looms for single shot “Novavax says its combo flu and COVID vaccine elicits a strong immune response similar to standalone flu and COVID jabs, according to initial results of a phase 1/2 trial. 
The results, announced Wednesday, came from a phase 1/2 trial in 642 older adults between 50 to 70 conducted in Australia. One hundred percent of the participants had been vaccinated by an initial series of one of the available COVID vaccines. The objective of the trial was to identify an optimal dose of the vaccine using a modelling-based approach.”

About health insurance

CMS Updates Guidance for Independent Dispute Resolution [IDR] Entities “CMS has updated its surprise billing guidance to require independent dispute resolution (IDR) entities to consider more than just the qualifying payment amount (QPA) when determining reimbursement amounts for out-of-network services under the No Surprises Act…
The No Surprises Act states that IDR entities should consider several different factors when determining a reimbursement rate.
The revised guidance from CMS addresses these concerns. It states that IDR entities must consider the QPA—the payer’s median contracted rate for the service—and other information that either party submits or the IDR entity requests.
For non-air ambulance items and services, additional factors include:

  • the provider’s level of training, experience, quality, and outcomes measurements

  • the provider’s regional market share

  • the acuity of the individual who received the item or service, or the complexity of providing the service

  • the teaching status, case mix, and scope of services that the provider or facility offers

  • demonstration of good faith efforts, or lack of efforts, from the provider and payer to enter into network agreements…

The guidance also stated that IDR entities may not consider usual and customary charges for the service, the amount that providers would have billed without the No Surprises Act provisions, or the reimbursement rate for the service by public payers.
The CMS guidance noted that it is not the IDR entity’s responsibility to determine whether the QPA is correct, make determinations of medical necessity, or review coverage denials.”
The No Surprises Act has two components: Provider provision of estimated treatment costs and balance billing guidelines.
Here are three additional resources:
Implementing the No Surprises Act From the MGMA
GOOD FAITH ESTIMATES (GFE) FOR UNINSURED (OR SELF-PAY) INDIVIDUALS From CMS
Notice of IDR Initiation Just-opened site from CMS

 Louisiana AG sues UnitedHealth, alleging drug overcharges in Medicaid “Louisiana Attorney General Jeff Landry has sued UnitedHealth Group, claiming that the healthcare and insurance giant has inflated drug charges in the state's Medicaid program by billions.
The suit was filed April 13 in state court, Bloomberg reported, and alleges that the company's pharmacy benefit manager Optum Rx took advantage of the secrecy of the pharmacy supply chain to "needlessly" charge Medicaid billions for prescription drug benefits.”

Bankrupt health sharing ministry leaves families with $50M in unpaid bills “About 10,000 families have been left with $50 million in unpaid medical bills after the shuttering of their health sharing ministry…
Sharity Ministries, formerly known as Trinity HealthShare, filed for bankruptcy and started the liquidation process in 2021, according to the report… 
The Atlanta-based nonprofit had faced challenges, class-action lawsuits, and cease-and-desist-orders in several states, where regulators said it had been operating as an unauthorized insurance provider, according to the report.”

Association of Medical Financial Hardship and Mortality Among Cancer Survivors in the United States “Among cancer survivors aged 18-64 years and 65-79 years, 29.6% and 11.0%, respectively, reported financial hardship in the past 12 months. Survivors with hardship had higher adjusted mortality risk than their counterparts in both age groups: 18-64 years (hazard ratio [HR] = 1.17, 95% confidence interval [CI] = 1.04 to 1.30) and 65-79 years (HR = 1.14, 95% CI = 1.02 to 1.28). Further adjustment for health insurance reduced the magnitude of association of hardship and mortality among survivors aged 18-64 years (HR = 1.09, 95% CI = 0.97 to 1.24). Adjustment for supplemental Medicare coverage had little effect among survivors aged 65-79 years (HR = 1.15, 95% CI = 1.02 to 1.29).” {Emphases added]

About hospitals and healthcare systems

Changes in Ownership of Hospital and Skilled Nursing Facilities: An Analysis of Newly-Released CMS Data Some Key Points:
“Analysis of this dataset indicates that 348 hospitals and more than 3,000 skilled nursing facilities experienced a change in ownership between 2016 and 2021, with wide variation in hospital rates across states.
—Ownership changes were more common in medium and larger hospitals (compared to small hospitals), hospitals with negative profit margins, and long-term care hospitals.
—Future research can link this new dataset to other sources of information to support policymaking and research on consolidation, health care quality, and health care costs.”

 Tenet Healthcare reports $139M profit, above-expectations EBITDA for Q1 2022 “As a whole, the company logged net operating revenues and operating income of more than $4.7 billion and $648 million, respectively, during the first quarter of the year. This is down slightly from 2021’s nearly $4.8 billion net operating revenues but up from its $520 million operating income.” 

About pharma

 EMA Reports Record Numbers of Adverse Drug Reactions in 2021 “The European Medicines Agency (EMA) said its EudraVigilance system for tracking suspected adverse reactions to medicines last year logged the highest number of cases ever, driven by COVID-19 vaccine reporting.
The agency said that more than 3.5 million individual case safety reports were recorded. The EudraVigilance database currently holds more than 22.3 million individual case safety reports relating to 12.9 million suspected adverse drug reactions. Adverse reactions can lead to several individual case safety reports, including the initial report and follow-ups.
More than 25 percent of the adverse event reports in 2021 discussed by the agency’s Pharmacovigilance Risk Assessment Committee were related to COVID-19 vaccines, the agency said.”

About the public’s health

 White House unveils national drug control strategy amid rising overdoses “The Biden administration on Thursday is sending its National Drug Control Strategy to Congress, amid a record level of drug overdoses…
he White House plan is centered on increasing treatment for addiction while also fighting trafficking for drugs. It calls for greater access to naloxone, a drug to fight overdoses that first responders can carry.  
It also includes measures aimed at boosting treatment for people at highest risk for overdoses, ‘which includes people experiencing homelessness [and] those who are incarcerated or re-entering society,’ the White House said.”

CMS releases health equity strategy centering on outreach, data collection “CMS’ equity action plan, released Wednesday, calls for increased efforts to expand outreach efforts to enroll people in coverage and standardize the use of data on social risk factors and other demographics. The agency has sought comments over the past year from stakeholders on how to incorporate equity into regulations…
Some of the actions CMS seeks to take on equity are:

  • Building on outreach effort to get more people into coverage via Medicare, Medicaid, Children’s Health Insurance Program and the Affordable Care Act’s exchanges.

  • Evaluating policies to ensure they help safety net providers that often care for underserved communities.

  • Promoting services in the culture and language of patients’ preferred languages and health literacy.

  • Incorporating screening on social needs and promoting broader access.”

MITIGATING AND PREVENTING MEDICAL DEVICE SHORTAGES AND PRIORITIZING PUBLIC HEALTH From the FDA’s Center for Devices and Radiological Health (CDRH): “The CARES Act, enacted in March 2020, gave the FDA device shortages authority for the first time. It required certain medical device manufacturers to provide information to the FDA on product availability, and on potential meaningful supply chain disruptions, during or in advance of a PHE [Public Health Emergency]. Thanks to that authority, CDRH has been able to better understand and monitor the complex web of supply chains that feed the medical device industry, and to be more proactive in solving problems before they occur…
To better protect public health, the statutory authority should be revised to require notifications from manufacturers to CDRH any time there is the potential for a device shortage (similar to the FDA’s broader authority for drugs)—and not just during or in anticipation of a PHE. Without more comprehensive authority, our device supply chain and U.S public health remain at risk.”

 About healthcare finance

 Wallaby hops to €500M acquisition of fellow stroke devicemaker Phenox  “Both companies have developed lines of neurovascular devices meant for use in interventional stroke treatments. Wallaby’s include a neuro-embolic coil system to treat aneurysms and a handful of stroke-focused catheters—while Phenox has put out ranges of flow diverters and stent retrievers, plus coating technologies for those implants. Phenox also owns its subsidiary Femtos, which uses femtosecond laser technology to churn out stents and other neurovascular implants.
Wallaby and Phenox have been partners since 2019 when the latter began serving as the exclusive distributor for several of Wallaby’s offerings in the U.S. and Europe.”

FTC Gives OK to Hikma’s Acquisition of Custopharm “The Federal Trade Commission (FTC) has granted approval to UK-based Hikma Pharmaceuticals to acquire generic drugmaker Custopharm from Water Street Healthcare Partners.
The approval is contingent on Custopharm, which is headquartered in Carlsbad, Calif., divesting its corticosteroid drug triamcinolone acetonide (TCA) to another Water Street subsidiary, Long Grove Pharmaceuticals.
Hikma sells several injectable generic medicines in the U.S. market. Without the divestment, the FTC believes Hikma would stop developing its own injectable TCA drug, which would limit competition in the market.”

Regeneron to Acquire Checkmate Pharmaceuticals for $250 Million “Regeneron has inked a deal to acquire Cambridge, Mass.-based Checkmate Pharmaceuticals for $250 million.
The purchase gives Regeneron access to Checkmate’s vitudolimod, an investigational toll-like receptor 9 (TLR 9) agonist that has shown promising antitumor activity.”

Humana to sell 60% stake in Kindred at Home to private equity firm “Humana is selling a 60 percent stake in its Kindred at Home hospice and personal care business to the private equity firm Clayton, Dubilier & Rice. 
The deal is worth $2.8 billion, according to an April 21 news release. The transaction is expected to close in the third quarter of 2022.”

Today's News and Commentary

About Covid-19

CDC asks Justice Department to appeal judge’s ruling that struck down mask mandate “The Centers for Disease Control and Prevention has recommended that the Justice Department appeal a federal judge’s decision that struck down the mask mandate on public transportation, the agency announced.”

 Rates of COVID-19 Among Unvaccinated Adults With Prior COVID-19 “Among 121 615 patients with more than 10 million days of follow-up, unvaccinated individuals with prior symptomatic COVID-19 had 85% lower risk of acquiring COVID-19 than unvaccinated individuals without prior COVID-19. Prior studies investigating protection against SARS-CoV-2 reinfection found similar results, with protection associated with natural immunity ranging from 80.5% to 100%. This level of protection is similar to that reported for mRNA vaccines.”

Rise in at-home testing means we could be undercounting Covid-19 cases even more than before “The Institute for Health Metrics and Evaluation estimates that only 7% of positive Covid-19 cases in the US are being detected, meaning case rates are actually 14.5 times higher than officially reported. The last time the infection detection rate was this low was at the outset of the pandemic, in March 2020.”

Omicron BA.2 overall makes up more than 90% of COVID variants in U.S. - CDC “The BA.2 sub-variant of Omicron and its sublineage BA.2.12.1 is estimated to make up more than 90% of the coronavirus variants in the United States as of April 16, the U.S. Centers for Disease Control and Prevention (CDC) said on Tuesday.”

About health insurance

 Anthem beats the Street with $1.8B in Q1 profit “Anthem beat the Street in the first quarter, reporting $1.8 billion in profit.
That's an 8.4% increase over the prior-year quarter, where the company earned $1.67 billion, according to its earnings report released Wednesday morning.
The insurer also surpassed Wall Street's expectations on revenue, according to Zacks Investment Research, with $38.1 billion. It reported $32.4 billion in revenue for the first quarter of 2021, making for 17.6% growth year over year.”
These figures give a 4.7% margin, which is solid in this sector.

About hospitals and healthcare systems

 Trinity to become sole owner of MercyOne, acquire CommonSpirit's share “Livonia, Mich.-based Trinity Health and Chicago-based CommonSpirit Health have signed an agreement for Trinity to acquire all MercyOne Health System assets and facilities.
Clive, Iowa-based MercyOne has 16 medical centers, 27 affiliate organizations and more than 420 care sites, according to a joint news release. It employs more than 20,000 people.”

About pharma

Promoting biosimilars could save large employers billions “In 2018, all U.S. self-insured employers could have saved $1.4 billion and realized significant savings for their employees by promoting the use of biosimilars in employer-sponsored health plans.”

 Alabama AG Ends Opioid Holdout With Deals Worth $276M “Alabama Attorney General Steve Marshall on Tuesday unveiled $276 million in settlements with opioid manufacturers and distributors, saying the deals give the state a better bargain than it would have come away with under nationwide settlements. The agreements put to rest Alabama's claims against manufacturers Endo Pharmaceuticals and Johnson & Johnson and distributor McKesson Corp. for their parts in exacerbating the opioid epidemic in Alabama…”

BREAKING: Endo Wins Reversal Of Opioid Default; Judge DQ'd “A Tennessee appeals court on Wednesday erased a trial judge's decision finding Endo Pharmaceuticals liable for opioid abuse because of discovery misconduct and disqualified the judge, saying he improperly approved the stunning sanction amid pending charges of bias against the drugmaker. In a seven-page opinion, a three-judge Tennessee Court of Appeals panel vacated the default judgment against Endo after finding that Circuit Court Judge Jonathan Lee Young appeared ‘antagonistic to the interests of those in the pharmaceutical industry’ when he discussed opioid litigation in Facebook posts and an interview with Law360.”

Johnson & Johnson to Settle Remicade Antitrust Lawsuit for $25 Million “Johnson & Johnson (J&J) has reportedly agreed to pay $25 million to settle a lawsuit over an alleged antitrust scheme involving its blockbuster immunosuppressive drug Remicade (infliximab).
The settlement, filed in a federal court in the Eastern District of Pennsylvania, is intended to resolve class-action claims against the company for its alleged obstruction of insurers covering generic versions of Remicade…”

FDA Approves Amneal’s Avastin Biosimilar “The FDA has approved Amneal Pharmaceuticals’ Alymsys (bevacizumab-maly) as a biosimilar of Roche’s blockbuster cancer drug Avastin.
The biosimilar was developed by mAbxience and licensed to Roche’s subsidiary Genentech in 2018 for supplying to the U.S. market.”

About the public’s health

Groups launch health equity coalition dedicated to chronic disease advocacy “Several civil rights, equity and healthcare groups have formed a coalition focused on advancing health equity among communities of color living with chronic diseases.
The Health Equity Coalition on Chronic Disease (HECCD) is a nationwide effort dedicated to current members—which are expected to expand—including the Association of Black Cardiologists, the Black Women’s Health Imperative, the National Association of Hispanic Nurses, the League of United Latin American Citizens and the National Minority Quality Forum. Its first year, it will focus on obesity, which disproportionately impacts communities of color.”

About healthcare IT

 Hive Ransomware HHS Cybersecurity warns that “Hive is an exceptionally aggressive, financially-motivated ransomware group known to maintain sophisticated capabilities who have historically targeted healthcare organizations frequently.”
More details are in the announcement. 

About healthcare personnel

 Investing in Primary Care: Why It Matters for Californians with Commercial Coverage “Key Findings:

  • The percentage of primary care spending varied more than twofold among the plans, from a low of 4.9% to high of 11.4%, mostly below other states’ recommended levels of 9% to 12%.

  • Greater investment in primary care among health plans was associated with better quality care and fewer hospital visits.

  • Among the provider organizations, larger investments in primary care were associated with better quality, better patient experience, and fewer hospital and emergency room visits, as well as a lower total cost of care.

  • If provider organizations in the lower brackets of primary care spending matched those in the highest bracket of spending, 25,000 acute hospital stays and 89,000 emergency room visits would be avoided, and $2.4 billion in overall health care spending would be saved in a single year.”

About health technology

 44 'breakthrough' medical devices that earned FDA approval “The FDA's Breakthrough Devices Program has helped at least 44 medical devices become authorized and enter the market since it launched in 2015, the agency said April 15.
The FDA has given a "breakthrough" designation to more than 650 medical devices, according to the agency's website. The label does not indicate safety approval, but designates a product as potentially lifesaving and fast-tracks its development, testing and approval process.”
The article lists these devices.

Today's News and Commentary

About Covid-19

COVID DATA TRACKER WEEKLY REVIEW From the CDC: “Currently, there are 14 (0.43%) counties, districts, or territories with a high COVID-19 Community Level, 175 (5.43%) counties with a medium Community Level, and 3,035 (94.14%) counties with a low Community Level. This represents a very slight (−0.19%) decrease in the number of high-level counties, a small (+1.55%) increase in the number of medium-level counties, and a corresponding (−1.36%) decrease in the number of low-level counties. Twenty-two (39.28%) of 56 jurisdictions had no high- or medium-level counties this week.
To check your COVID-19 community level, visit COVID Data Tracker.”

COVID-19 Travel Recommendations From the CDC: “There are no Level 4 COVID-19 Travel Health Notices at this time.”
See the site for country-specific recommendations.

New CDC team: A weather service to forecast what’s next in pandemic “A new team of federal health scientists officially embarks Tuesday on a mission to provide what has often been absent from the nation’s response to the coronavirus pandemic: better, faster information about what’s likely to happen next in this public health emergency and in future outbreaks…
About 100 scientists will analyze technical data and communicate policy options to decision-makers and the public about how the virus is behaving and who is most at risk — in user-friendly terms…
The Center for Forecasting and Outbreak Analytics, which starts with $200 million in funding, was created last summer to improve understanding by the CDC and the government more broadly of the coronavirus — and future outbreaks — in real time. White House officials plan to formally launch the effort Tuesday at a summit on strengthening U.S. early-warning systems for health threats.”

Moderna's bivalent beta booster betters Spikevax versus omicron, pointing to promise of variant-specific jabs “Moderna’s bivalent COVID-19 vaccine has bettered the antibody response of Spikevax against omicron when given as a booster..
The clinical data are on the bivalent vaccine Moderna developed in response to the beta variant, not the omicron-specific booster it is testing in another phase 2/3 clinical trial.”
Comment: Will we be chasing variants for Covid-19 vaccines as we do annually for influenza vaccines? Regarding the latter, researchers are looking for a “universal vaccine” that will be effective against all strains.

 4 Michiganders with COVID-19 strain unique to mink were likely 1st U.S. spillover cases “Four Michiganders — a taxidermist, his wife and two mink farm employees — were infected with a unique coronavirus strain connected to minks, leading Michigan health officials and the CDC to conclude they likely contracted the first known U.S. cases of so-called animal-to-human virus ‘spillover.’
Michigan’s four mink-connected COVID-19 cases — the only known animal-to-human cases in the U.S. to date — infected more people than was previously known.”

About health insurance

Supreme Court nixes appeal on Arkansas' Medicaid work requirements program “The Supreme Court has shot down a case surrounding the legality of Medicaid work requirements, sending the case back to a lower court with instructions to dismiss it entirely.
The decision on Monday in Becerra vs. Gresham comes more than a year after the court canceled oral arguments in the work requirements case in March 2021. While a major policy priority for the Trump administration, President Joe Biden’s Centers for Medicare and Medicaid Services has moved to unwind the requirements.
The Supreme Court remanded the case during back to the U.S. Court of Appeals for the District of Columbia, alongside instructions to dismiss the case as moot. Justices did not elaborate further on the reasons behind the decision, which was included in a list of orders on Monday.”

 Medicare Advantage Outperforms Fee-For-Service Medicare on Cost Protections for Low-Income and Diverse Populations “Low-income Medicare beneficiaries are more likely to enroll in Medicare Advantage than higher-income beneficiaries. Over 46 percent of beneficiaries under 200 percent of the Federal Poverty Level (FPL)2 were enrolled in Medicare Advantage, compared with 28 percent of beneficiaries over 400 percent of the FPL (data not shown). The difference between the two programs is growing; in 2018, 40 percent of low-income Medicare beneficiaries chose Medicare Advantage. This 6 percentage point difference is a 15 percent increase year over year in the number of low-income Medicare beneficiaries choosing Medicare Advantage….
On average, beneficiaries enrolled in Medicare Advantage spend less on out-of-pocket costs and premiums than those in FFS Medicare. Medicare Advantage beneficiaries report spending $1,965 less on out-of-pocket costs and premiums compared to FFS Medicare beneficiaries… This difference in out-of-pocket spending has grown by $325 since 2018. Between 2018 and 2019, health care spending rose 5 percent for Medicare Advantage beneficiaries and 9 percent for FFS Medicare beneficiaries.”

Anthem pays $4.5M to Indiana hospitals in ER billing dispute “For five years, health insurer Anthem Inc. has tried to clamp down on what it considered unnecessary, expensive visits to emergency rooms by denying claims or downgrading reimbursements for ER visits that turned out not to be life-threatening…
A group of 11 Indiana hospitals complained that Anthem’s policy was unlawful and breached their contracts, costing them millions of dollars. And a federal arbitrator has agreed, ordering Anthem to pay them $4.5 million.
Anthem, which fought the case for two years, says it has complied with the order.
But the hospitals say they can claim at least another $12 million from Anthem for tens of thousands of additional claims that it says Anthem has downgraded and not paid in full. And the count of improperly denied or downgraded claims, they say, is growing by the day.”

About hospitals and healthcare systems

 CMS pitches inpatient payment rule for 2023: 10 things to know “CMS released its annual Inpatient Prospective Payment System proposed rule April 18, which proposes a reimbursement boost for acute care hospitals. 
A really good summary of some of the major features of the 1,786-page proposed rule. The comment period closed on June 17.
Focusing on the overall payment and implications is: Hospitals to receive a proposed 3.2% payment increase in 2023 “CMS estimates that payments to hospitals will increase in 2023 by $1.6 billion. The proposed increase applies to acute care hospitals that successfully participate in the Hospital Inpatient Quality Reporting Program and are meaningful electronic health record users.
The 3.2% increase reflects a market basket update of 3.1% reduced by a projected 0.4 percentage point productivity adjustment and an increase of 0.5% required by statute. In addition, CMS projects Medicare disproportionate share hospital payments and Medicare uncompensated care payments combined will decrease by approximately $0.8 billion…
In addition, in this proposed rule, CMS is proposing to suppress the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) and five Hospital Acquired Infection measures for the 2023 program year. Similarly, CMS is proposing to suppress all six measures in the Hospital-Acquired Condition Reduction Program for the 2023 program year. If finalized, hospitals would not be given a measure score, a Total HAC score, or receive a payment penalty.”
The AHA has expressed mixed feelings about these proposals in this press release: AHA Statement on FY 2023 Proposed IPPS Rule

About pharma

After rivals' FDA rebuffs, GSK targets class-first oral approval in chronic kidney disease anemia “The FDA has accepted GSK’s application for daprodustat as an oral therapy for patients with anemia of chronic kidney disease (CKD), the company said Tuesday. The FDA plans to deliver its daprodustat verdict by Feb. 1, 2023, GSK said…
Overall, daprodustat’s studies showed the drug helped improve or maintain target hemoglobin levels without an increase of major cardiovascular events versus standard of care—an erythropoietin stimulating agent (ESA)—across both dialysis and non-dialysis patients, GSK said.”
Comment: Dialysis is a bundled service, and, according to CMS, includes “Erythropoiesis stimulating agents (ESAs) and their oral or other forms of administration that are for the treatment of ESRD.” It will be interesting to see how GSK prices this oral medication vis-a-vis the generically-available injectable agents.

Johnson & Johnson, after weak quarter of vaccine sales, will no longer include it in guidance “Johnson & Johnson never came up with a name for its COVID-19 vaccine. Similarly, it never found a niche for the jab, despite its hype as a convenient single-shot option to the double-dose vaccines from Moderna, Pfizer-BioNTech and AstraZeneca.
And after a disappointing quarter of sales, the company will no longer includethe vaccine in its revenue projections…
J&J's COVID vaccine sales for the first quarter were $457 million, far off from Wall Street’s estimate of $785 million. In January, when the company reported that 2021's vaccine sales reached $2.4 billion, it projected 2022 sales to come in at between $3 billion and $3.5 billion.”

 Johnson & Johnson inks $99M opioid settlement with West Virginia: report  “J&J stated that the $99 million settlement will directly support local community efforts to seek “meaningful progress” in addressing the opioid crisis in West Virginia. The company emphasized that its marketing and promotion of prescription opioid medications were “appropriate and responsible” and that its three opioid medications accounted for less than 1% of total opioid prescriptions in West Virginia and the U.S. since launch.  
Echoing its previous statements regarding opioid addiction settlements, J&J said the settlement is not an admission of liability or wrongdoing.”

Biotech's top 10 money raisers of 2021 FYI

About the public’s health

Weekly U.S. Influenza Surveillance Report From the CDC:
—The cumulative hospitalization rate in the FluSurv-NET system is higher than the end-of-seasons rates for the 2020-2021 and 2011-2012 seasons, but lower than the rate seen at this time during the four seasons preceding the COVID-19 pandemic.
—Three influenza-associated pediatric deaths were reported this week. There have been 19 pediatric deaths reported this season.
—CDC estimates that, so far this season, there have been at least 4.3 million flu illnesses, 42,000 hospitalizations, and 2,500 deaths from flu.”

Potential Gains in Life Expectancy [LE] Associated With Achieving Treatment Goals in US Adults With Type 2 Diabetes “This study quantified the potential gains in LE associated with different levels of biomarkers in patients with diabetes. Differences in HbA1c and BMI were found to have the strongest association with LE gain from a population perspective. At the individual level, we observed a large variation in the benefits associated with better diabetes care, associated with patients’ individual characteristics. The benefit of biomarker control was most pronounced in younger adults, and diminished as people aged. Better control of biomarkers can potentially increase the LE by 3 years in an average person with T2D in the US. For individuals with very high levels of HbA1c, SBP, LDL-C, and BMI, controlling biomarkers can potentially increase LE by more than 10 years.”
Comment: The benefit of “tight control” of diabetes has been contentious. This study gives some credence to its value.

 Johns Hopkins Beats $1B Guatemalan Syphilis Study Suit “A Maryland federal judge on Monday freed Johns Hopkins University and the Rockefeller Foundation against a $1 billion suit filed by Guatemalans who claimed that the institutions participated in controversial syphilis experiments on them in the 1940s, finding two doctors involved in the experiments didn't act on their behalf. U. S. District Judge Theodore D. Chuang said there wasn't sufficient evidence to show that the Rockefeller Foundation was responsible for the acts of two doctors or that university professors conspired to violate the Alien Tort Statute in a suit over experiments performed on more than 1,300 prisoners, soldiers and psychiatric patients…”
While many people are familiar with the Tuskegee study, this “research” is less well-known. For more information, see:  First, Do No Harm: The US Sexually Transmitted Disease Experiments in Guatemala

About healthcare personnel

 HHS directs $227M toward community health worker training programs “The Biden administration is directing $226.5 million in American Rescue Plan funding toward a new multiyear training program for community health workers and health support workers, the U.S. Department of Health and Human Services (HHS) announced Friday.
Funded using American Rescue Plan dollars, the Community Health Worker Training Program aims to add 13,000 new professionals the administration said play a vital role in connecting the public to local health resources.”

Today's News and Commentary

About Covid-19

Federal judge voids mask mandate for airplanes, in other transportation settings “U.S. District Judge Kathryn Kimball Mizelle of the Middle District of Florida said the mandate exceeds the statutory authority of the Centers for Disease Control and Prevention. Federal officials last week had extended the mask mandate for commercial flights and in other transportation settings, including on buses, ferries and subways, until at least May 3.”

How the Test-to-Treat Pillar of the US Covid Strategy Is Failing Patients “…large swaths of the country had no test-to-treat pharmacies or health centers listed as of April 14. And the website of the largest participant, CVS, has significant technical issues that make booking an appointment difficult.”

Americans Over 60 Should Get Second Booster, Official Says “Americans over 60 should get a second booster shot of a coronavirus vaccine, Dr. Ashish K. Jha, the new White House Covid-19 response coordinator, said on Sunday, citing “pretty compelling” new data from Israel indicating that a fourth shot significantlyreduced infections and deaths among older people there.”

HHS Distributing $1.75 Billion in Provider Relief Fund Payments to Health Care Providers Affected by the COVID-19 Pandemic “The Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA)… announced more than $1.75 billion in Provider Relief Fund payments to 3,680 providers across the country. With this disbursement, HRSA has distributed approximately $13.5 billion from the Provider Relief Fund to nearly 86,000 and nearly $7.5 billion in American Rescue Plan (ARP) Rural payments to more than 44,000 providers since November 2021.

FDA greenlights first breathalyzer test for COVID-19 “A portable breathalyzer developed by InspectIR Systems aims to deliver a result within three minutes by looking for the exhaled chemical compounds that can come with an infection. 
The device includes its own miniaturized mass spectrometer, shrunk down to about the size of a carry-on suitcase. It’s designed to be used under the supervision of a healthcare professional in locations such as doctors' offices, hospitals and mobile testing sites…
While positive results should be confirmed with a secondary PCR test, the FDA said the device’s negative results could be accurate enough for use in widespread screening settings when placed in context with the person’s recent exposures and their current signs and symptoms.”

New COVID-19 nasal spray outperforms current antibody treatments in mice: A single inhaled dose treated or even prevented infection by COVID-19 and its variants “Designed computationally and refined in the laboratory, the new protein therapies thwarted infection by interfering with the virus' ability to enter cells. The top protein neutralized the virus with similar or greater potency than antibody treatments with Emergency Use Authorization status from the U.S. Food and Drug Administration (FDA). Notably, the top protein also neutralized all tested SARS-CoV-2 variants, something that many clinical antibodies have failed to do.”

HHS Distributing $1.75 Billion in Provider Relief Fund Payments to Health Care Providers Affected by the COVID-19 Pandemic “The Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), today announced more than $1.75 billion in Provider Relief Fund payments to 3,680 providers across the country. With this disbursement, HRSA has distributed approximately $13.5 billion from the Provider Relief Fund to nearly 86,000 and nearly $7.5 billion in American Rescue Plan (ARP) Rural payments to more than 44,000 providers since November 2021.”

About health insurance

Kaiser Permanente pledges $200 million to fight homelessness “Responding to a growing need for affordable housing, Kaiser Permanente announced Friday the company will invest $200 million for new housing and community needs for low-income residents.
The Oakland-based health care giant plans to shift funds from its investment portfolio to support affordable housing and support services. The company sees the investment as an extension of its health care services, saying that public health is bolstered by stable living conditions and shelter.”

5 Charts About Public Opinion on the Affordable Care Act From a Kaiser Family Foundation poll.
“Following Republican efforts to repeal the ACA in the summer of 2017, KFF Health Tracking Polls found a slight uptick in overall favorability towards the law, and since then a somewhat larger share has held a favorable than an unfavorable view. The most recent KFF Tracking Poll conducted in March 2022 found slightly more than half of the public (55%) hold a favorable opinion of the ACA while about four in ten (42%) hold a negative opinion of the law. Views of the ACA are still largely driven by partisanship: nearly nine in ten Democrats (87%) along with six in ten independents (58%) view the law favorably, while eight in ten Republicans (79%) hold unfavorable views.”
The most popular provisions are:
1. Prohibiting health insurance companies from denying coverage for people with pre-existing conditions.

2. Prohibiting health insurance companies from charging sick people more.

3. Prohibiting health insurance companies from denying coverage to pregnant women.

4. Requiring health insurance companies to cover the cost for most preventive services.

5. Prohibiting health insurance companies from setting a lifetime limit. 

Bright Health Group Continues to Drive Focus on Consumer Retail Markets with Fully Aligned Model “Bright Health Group, Inc… the first technology-enabled, Fully Aligned system of care built for healthcare's consumer retail market…announced its decision to focus Bright HealthCare’s geographic footprint by no longer offering Individual and Family Plans in Illinois, New Mexico, Oklahoma, South Carolina, Utah, and Virginia after 2022. These markets are forecasted to contribute less than 5% of total Bright Health Group revenue for 2022 and will have an immaterial impact on revenue in 2023 and beyond.
The strategic decision reflects the company’s increasing focus on growing in markets where it can deliver the greatest impact, drive differentiated value through its Fully Aligned care model and achieve operational excellence.

About hospitals and healthcare systems

Crozer Health quietly threatening to shut off paramedic services for municipalities — unless they pay up “Crozer Health, the four-hospital system in Delaware County, has been quietly reaching out to municipalities, threatening to shut off emergency medical services unless they pay up…
Crozer has delivered its Advanced Life Support response vehicles, also known as chase cars, to the municipalities for quite some time. The vehicles, while they don’t transport patients, are staffed by a paramedic, who has the highest level of prehospital care education.”

About pharma

Bristol Myers settles HIV antitrust suit, but J&J, Gilead still await their day in court “Bristol Myers Squibb will hand over up to $11 million to settle a lawsuit claiming it, Gilead Sciences and Johnson & Johnson used anticompetitive marketing tactics to block generic competition to HIV drugs. Importantly, the other two companies aren't involved in the settlement.

About the public’s health

E-cigs using synthetic nicotine come under FDA oversight “U.S. regulators will soon begin cracking down on vaping companies using a now-closed loophole, including a line of fruit-flavored e-cigarettes that have become teenagers’ top choice….
Food and Drug Administration can regulate e-cigarettes and similar products that use synthetic nicotine. 
The action targets Puff Bar and several other vaping companies that recently switched their formulas to laboratory-made nicotine to skirt FDA oversight.”

FDA Authorizes Marketing of Tobacco Products that Help Reduce Exposure to and Consumption of Nicotine for Smokers Who Use Them “U.S. Food and Drug Administration authorized the marketing of 22nd Century Group Inc.’s “VLN King” and “VLN Menthol King” combusted, filtered cigarettes as modified risk tobacco products (MRTPs), which help reduce exposure to, and consumption of, nicotine for smokers who use them. These are the first combusted cigarettes to be authorized as MRTPs and the second tobacco products overall to receive “exposure modification” orders, which allows them to be marketed as having a reduced level of, or presenting a reduced exposure to, a substance.” 

About healthcare personnel
American Board of Medical Specialties and New Standards for Continuing Certification “The Standards reflect 2 foundational changes in how ABMS and the ABMS member boards deliver on their professional self-regulatory mission. The first foundational change reflects the intent of the Standards to bring value to both the public and the profession… This is achieved through balancing formative and summative assessment methods, enhancing relevance to practice, and providing opportunities to address identified knowledge deficits prior to certificate loss. The requirement for a 10-year high-stakes examination has been removed and replaced by modular or longitudinal formative assessments that support learning through means convenient to diplomates…
The second foundational change recognizes that the network of professional self-regulation of medical care represents the collective responsibility of multiple organizations, not just the member boards… The improving health and health care standards require the member boards to work with their specialty societies and others to define a quality agenda for each specialty, including focusing on important disparities within and across specialties. To facilitate implementation of the improving health and health care standards, a learning community is being established that is codirected by leadership from ABMS and the specialty societies.”

Federal malpractice database may not work as intended “Hospitals are required by law to submit a report to the data bank if a doctor is retiring to avoid investigation. However, the only way the data bank or other government agencies can find out that a hospital has broken the law is through the actions of whistleblowers.”

First Criminal Trials Over Wage-Fixing, Hiring Practices End in Loss for Justice Department “Dialysis provider DaVita Inc… and its former chief executive officer, Kent Thiry, were acquitted Friday in Denver on three counts of conspiring with other companies to not recruit each other’s senior-level employees. Separately on Thursday, a Texas jury acquitted the former owner and clinical director of a home-health staffing company of conspiring with rivals to reduce their contractors’ pay.The two prosecutions marked the first ever federal criminal cases focused on alleged labor-market collusion. The antitrust division has pursued civil cases in recent years against companies that entered into agreements to not raid each other’s workers, but charging the conduct as a crime marked a major escalation of the government’s approach.”

  About healthcare finance

$1B joint venture sets sights on ASCs, medical office buildings “Big Sky Medical, a real estate investment manager, and Newmark, a real estate advisory and services company, have partnered to create a medical office building portfolio worth $1 billion…
The joint venture, seeded by a more than $400 million medical office portfolio that Big Sky Medical aggregated over the past year, will target medical office buildings across the country.
The seed portfolio includes 24 ASCs and medical office buildings that total more than 1 million square feet across seven states in the South and the Midwest, according to the report. Tenants include Cleveland Clinic; Winston-Salem, N.C.-based Novant Health; Dallas-based Baylor Scott & White Health and Texas A&M Health Science Center in Bryan.”

 

 

Today's News and Commentary

About Covid-19

 U.S. renews COVID-19 public health emergency “The public health emergency was initially declared in January 2020, when the coronavirus pandemic began. It has been renewed each quarter since and was due to expire on April 16.”

NY health officials say two new subvariants ‘likely’ fueling rise in cases “New York health officials on Wednesday said that two newly identified subvariants of omicron could be helping fuel an increase in COVID-19 cases in the state.  
The New York State Department of Health said the two subvariants are known as BA.2.12 and BA.2.12.1 and are thought to be even more transmissible than the original BA.2 subvariant of omicron, which already spread more easily than earlier variants.”

Covid booster shot bolsters protection in 5-to-11-year-olds, Pfizer and BioNTech say “Pfizer and BioNTech say they intend in coming days to request authorization from the Food and Drug Administration for a booster for 5-to-11-year-olds. The additional shot was given six months after children were fully vaccinated.”

About health insurance

 UnitedHealth Group posts $5B in profit for Q1 “Revenues at UnitedHealthcare were $62.6 billion, growth of 13.6% year over year from the $55.1 billion haul in the first quarter of 2021. The insurer added 1.5 million members over the quarter, including notable growth in Medicare Advantage, dual special needs plans and Medicaid.
UnitedHealth said it has added 350,000 members across its new product offerings, such as virtual-first plans, over the past year.
Optum's revenue grew 18.9% year over year, reaching $43.3 billion. At OptumRx, the company's pharmacy benefit management arm, revenues were up 11% as it grew its base with large health plan clients and further expanded offerings in behavioral health, specialty pharmacy and e-commerce.”

About pharma

 FDA Issues Manual on Complex APIs “The FDA’s Center for Drug Evaluation and Research (CDER) yesterday released a Manual of Policies and Procedures (MAPP) document that spells out how the Office of Generic Drugs (OGD) will classify complex new drug products and drug-device combination products assigned to CDER.” 

McKinsey Opened a Door in Its Firewall Between Pharma Clients and Regulators “A review by The New York Times of thousands of internal McKinsey documents found that the firm repeatedly allowed employees who served pharmaceutical companies, including opioid makers, to also consult for the F.D.A., the drug industry’s primary government regulator.
And, the documents show, McKinsey touted that inside access in pitches to private clients. In an email in 2014 to Purdue’s chief executive, a McKinsey consultant highlighted the firm’s work for the F.D.A. and stressed “who we know and what we know.”

About the public’s health

 Merck's next-gen pneumococcal vaccine receives FDA breakthrough status ahead of phase 3 trial “V116—one of three pneumococcal vaccines in Merck’s clinical pipeline—targets serotypes that account for 85% of cases of invasive pneumococcal disease among individuals aged 65 and over in the U.S., including eight serotypes not currently covered by any licensed vaccines. The company expects to begin phase 3 trials later this year.”

Today's News and Commentary

About Covid-19

Mask mandate extended for air travel and public transit through May 3 “Masks will continue to be required until at least May 3 when flying commercially and in other transportation settings, including on buses, ferries and subways, while health officials monitor an uptick in coronavirus cases, the Centers for Disease Control and Prevention said Wednesday.” 

 The world surpasses half a billion known coronavirus cases, amid concerns about testing ”The number of new cases reported around the globe each day has been declining for some time now; the average over the past week has been about 1.1 million cases a day, according to the Center for Systems Science and Engineering at Johns Hopkins University. That’s about 32 percent fewer than two weeks ago.
But over the course of the pandemic, countries with limited public health resources may only have detected and confirmed a tiny fraction of the cases in their populations. And more recent figures may miss many at-home rapid test results that are never officially reported.”

Delta Air Lines drops health insurance surcharge for unvaccinated employees “Delta Air Lines ended its $200 monthly health insurance surcharge for unvaccinated employees, CEO Ed Bastian said during an earnings call April 13. 
Delta dropped the insurance surcharge this month. The policy was announced in August 2021 and took effect in November 2021.”
This change might presage other companies’ actions.

About health insurance

 Marketplace Premiums Continue to Decline As Competition Rises From the RWJF: “Key Findings

  • Premiums for benchmark plans in the marketplace fell 1.8 percent nationally in 2022, following declines of 3.2 percent in 2020 and 1.7 percent in 2021. These trends contrast with premium increases in employer-sponsored plans of 3.6 percent in 2021 and 3.9 percent in 2020.

  • Most states saw reductions in marketplace premiums, but premium prices varied considerably across states. Eleven states had average benchmark premiums of more than $500 a month for a 40-year-old nonsmoker, while six states had premiums less than $365 per month for similar individuals.

  • Regions with higher unemployment rates saw higher premium increases.

  • The number of insurers participating in the marketplace increased from 198 to 288 between 2020 and 2022 in the regions analyzed. Additionally, increases in the number of insurers in a marketplace correlated with lower premium increases. Health premiums in markets with only one insurer were $189.50 higher, on average, relative to markets with five or more insurers.”

Judge tosses Cigna lawsuit from shareholders over loss of $1.85B termination fee in failed Anthem merger “A Delaware judge dismissed a lawsuit from Cigna shareholders April 7 that claimed executives with the company fumbled a $1.85 billion termination fee following the failed $54 billion merger with Anthem in 2017…
The lawsuit alleged that Cigna President and CEO David Cordani, six board members, Cigna's attorney and Teneo consultants spread misinformation, undermined the proposed merger and violated their fiduciary duties. Shareholders also claimed that Mr. Cordani sabotaged the proposal because he would not remain CEO of the new company.
The chancery court ruled that stockholders did not prove it would have been pointless to demand an investigation of damage claims by the payer's board.”

Optum Ventures invests in personal assistant service for aging adults “Optum Ventures is investing in senior care startup DUOS to help fuel the company's growth and build out its technology capabilities.
Launched in 2021, New York-based DUOS helps place expert personal assistants, called “Duos," into the homes of seniors. The company works directly with consumers as well as with payer and provider organizations.”

About hospitals and healthcare systems

Hospital Cost Tool “The National Academy for State Health Policy’s (NASHP) Hospital Cost Tool (HCT) dashboard aims to provide state policymakers and researchers with analytical insights into how much hospitals spend on patient care services, and how such costs relate to the hospital charges (list prices) and actual prices paid by health plans. The dashboard reports on a range of measures for hospital revenue, costs, profitability, and break-even points across over 4,600 hospitals nationwide for the period from 2011 through 2019. The dashboard offers options to view data at the hospital, state, and health system levels. The underlying HCT dataset includes approximately 60 variables extracted and calculated using data from the national Healthcare Cost Report Information System (HCRIS) as the main data source. Hospitals in this dataset represent approximately 70 million patient discharges and $49 billion hospital net income in the most recent reporting year.”
Fascinating data base and worth "playing” with entries.

Hospitals challenge Lown Institute's community benefits rankings A followup to yesterday’s article. Read the article for details, but briefly, Rick Pollack, president and CEO of the AHA, “said the report ignores certain categories of community investment, such as researching lifesaving treatments and cures and training and educating the healthcare workforce.”
Comment: Hospitals receive research grants for new technology development and graduate medical education payments.

 Providence Health & Services Agrees to Pay $22.7 Million to Resolve Liability From Medically Unnecessary Neurosurgery Procedures at Providence St. Mary’s Medical Center “Providence Health & Services Washington (Providence) has agreed to pay $22,690,458 to resolve allegations that it fraudulently billed Medicare, Medicaid, and other federal health care programs for medically unnecessary neurosurgery procedures…
 Between 2013 and 2018, Providence St. Mary’s employed neurosurgeons identified in the Settlement Agreement as Dr. A and Dr. B. Providence St. Mary’s paid neurosurgeons based on a productivity metric that provided them a financial incentive to perform more surgical procedures of greater complexity. Between 2014 and 2018, Dr. A was one of the highest producing neurosurgeons in the entire Providence system. Between 2014 and 2017, based on the productivity metric, Providence paid Dr. A between $2.5 million and $2.9 million per year.”

About pharma

 GSK adds to cancer portfolio with deal to buy Sierra Oncology “GlaxoSmithKline entered into an agreement to buy Sierra Oncology for $55 per share in cash, representing an equity value of around $1.9 billion, the companies announced Wednesday. The deal, which is expected to close by the third quarter, will bolster GlaxoSmithKline's oncology portfolio with the addition of the experimental drug momelotinib.
 Earlier this year, Sierra reported that the Phase III MOMENTUM study of momelotinib in certain patients with myelofibrosis met all of its primary and key secondary endpoints, improving anaemia and other symptoms of the disease. Regulatory submissions for the orally bioavailable JAK1, JAK2 and ACVR1/ALK2 inhibitor are expected to be made in the US this quarter and in Europe in the second half of the year.”

Halozyme to Acquire Antares Pharma to Create a Specialty Product and Drug Delivery Leader Halozyme Therapeutics, Inc. and Antares Pharma, Inc. today announced that the companies have entered into a definitive agreement pursuant to which Halozyme will acquire Antares for $5.60 per share in cash. The transaction, which values Antares at approximately $960 million, was unanimously approved by both the Halozyme and Antares Boards of Directors…
’The addition of Antares, particularly with its best-in-class auto injector platform and specialty commercial business, augments Halozyme's strategy, further strengthens our position as a leading drug delivery company and extends our strategy to include specialty products,’ said Dr. Helen Torley, president and chief executive officer of Halozyme.”

ICER finds bluebird's potential $2.1M gene therapy cost-effective as FDA adcomm scheduled for June The Institute for Clinical and Economic Review (ICER) said Wednesday “that bluebird’s [the company does not capitalize its name] potential gene therapy for a rare blood disorder [beta thalassaemia, which is not very rare]— which goes before an FDA adcomm in June — could be cost-effective even though it may be one of the most expensive drugs to ever hit the US market.
At the proposed price of $2.1 million per treatment course (to be paid across five years, given treatment success), ICER said that all eligible patients could be treated with Zynteglo, or beti-cel, which is already approved in the EU, over that span without crossing the watchdog’s budget impact threshold of $734 million per year.”

About the public’s health

 COVID-19, overdoses pushed US to highest death total ever “2021 was the deadliest year in U.S. history, and new data and research are offering more insights into how it got that bad.
The main reason for the increase in deaths? COVID-19, said Robert Anderson, who oversees the Centers for Disease Control and Prevention’s work on death statistics.
The agency this month quietly updated its provisional death tally. It showed there were 3.465 million deaths last year, or about 80,000 more than 2020′s record-setting total.”
In a related article: Changes in Life Expectancy Between 2019 and 2020 in the US and 21 Peer Countries “In this cross-sectional study, calculations of life expectancy based on official death counts revealed that US life expectancy decreased by 1.87 years overall, and by 3.70 years in Hispanic populations and 3.22 years in non-Hispanic Black populations. The decrease in life expectancy in peer countries was a mean of 0.58 years, with no country experiencing a decrease rivaling that of the US.”

STDs increased during the first year of the COVID-19 pandemic “Reported cases of sexually transmitted diseases (STDs) in the United States decreased during the early months of the COVID-19 pandemic, but most resurged by the end of that year. Reported cases of gonorrhea, syphilis, and congenital syphilis surpassed 2019 levels, while chlamydia declined (likely due to decreased STD screening and underdiagnosis during the pandemic). The data provide the clearest picture yet of COVID-19’s impact on the U.S. STD epidemic.”

Class Action Against Burger King Alleges Whoppers Packaging Contains Harmful Level of PFAS “On Monday, Azam Hussain filed a class action lawsuit in the Northern District of California against Burger King Corporation alleging unfair competition and fraud for the use of per- and polyfluoralkyl substances (PFAS) in its products packaging…
According to the complaint, the plaintiff has purchased products from Burger King including its popular Whopper product based on Burger King’s claims that the Whopper was safe for consumption and a sustainable product. However, Hussain argues that himself and other similarly situated consumers were harmed and deceived by Burger King’s false advertising due to the presence of PFASs in the Whopper’s packaging.”

Biden Administration Announces Boost for Rural Health Care in Midterm Election Push Agriculture Secretary Tom Vilsack “spoke to KHN ahead of an announcement Wednesday that the Agriculture Department has awarded $43 million in grants to 93 rural health care providers and community groups in 22 states. Biden administration Cabinet members are fanning out across the country to promote the benefits of the $1.9 trillion American Rescue Plan Act and a $1.2 trillion infrastructure package to rural Americans.”

About healthcare personnel

 Physician Partners of America to Pay $24.5 Million to Settle Allegations of Unnecessary Testing, Improper Remuneration to Physicians and a False Statement in Connection with COVID-19 Relief Funds “Physician Partners of America LLC (PPOA), headquartered in Tampa, Florida, its founder, Rodolfo Gari, and its former chief medical officer, Dr. Abraham Rivera, have agreed to pay $24.5 million to resolve allegations that they violated the False Claims Act by billing federal healthcare programs for unnecessary medical testing and services, paying unlawful remuneration to its physician employees and making a false statement in connection with a loan obtained through the Small Business Administration’s (SBA) Paycheck Protection Program (PPP)…
The United States alleged that PPOA caused the submission of claims for medically unnecessary urine drug testing (UDT), by requiring its physician employees to order multiple tests at the same time without determining whether any testing was reasonable and necessary, or even reviewing the results of initial testing (presumptive UDT) to determine whether additional testing (definitive UDT) was warranted. PPOA’s affiliated toxicology lab then billed federal healthcare programs for the highest-level UDT. In addition, PPOA incentivized its physician employees to order presumptive UDT by paying them 40% of the profits from such testing in violation of the Stark Law…” 

About health technology

Appeals court: J&J must pay $302M in pelvic mesh case “A California appeals court has upheld a lower court ruling that Johnson & Johnson must pay penalties to the state for deceptively marketing pelvic mesh implants for women, but reduced the amount by $42 million to $302 million.
Johnson & Johnson had appealed in 2020 after Superior Court Judge Eddie Sturgeon assessed the $344 million in penalties against Johnson & Johnson subsidiary Ethicon.”

Today's News and Commentary

About Covid-19

 Veru drug trial stopped early for 'overwhelming efficacy' in seriously ill COVID-19 patients “Veru said Monday that its cytoskeleton disruptor sabizabulin reduced deaths by 55% compared to placebo in a Phase III trial of seriously ill patients hospitalised for COVID-19. CEO Mitchell Steiner said the study is the first to demonstrate a clinically and statistically meaningful survival benefit in this population, adding ‘we strongly believe that sabizabulin, with its dual anti-viral and anti-inflammatory properties…can be that greatly needed oral therapy for hospitalised moderate-to-severe COVID-19 patients.’
Veru said the study was stopped early on the advice of an independent data monitoring committee due to ‘overwhelming’ efficacy, with company shares surging over 203% on the news.”

Many Republicans are ready to end the public health emergency “The Biden administration is widely expected to renew the declaration expiring at the end of the week, ensuring the continuation of critical resources to battle the coronavirus pandemic. But the decision comes amid increasing pressure from Republicans to wind down such supports and to treat the virus as endemic…
Here’s a snapshot of what could go away without a public health emergency: 

  • Private insurers and Medicare would no longer cover free, rapid at-home tests.

  • Telehealth services wouldn’t be available to millions of Medicare beneficiaries roughly five months after the emergency ends.

  • States would begin the lengthy process of determining who no longer qualifies for Medicaid and must be removed from the safety-net program.”
    If the PHE is extended before April 16, it would expire July 15.

Moderna Recalls Nearly 800,000 Doses of Its COVID-19 Vaccine “Moderna has recalled 764,900 doses of its COVID-19 vaccine, Spikevax, due to potential contamination with a foreign body.
The affected lot was manufactured by ROVI Pharma Industrial Services at a contract manufacturing facility in Spain.”
The recall apparently does not affect doses in the US.

FDA Updates EUA for J&J COVID-19 Vaccine to Extend Shelf Life “The FDA has amended its Emergency Use Authorization (EUA) for Johnson & Johnson’s COVID-19 vaccine, extending the vaccine’s shelf life from nine months to 11 months, provided the doses are stored between 2 and 8 degrees Celsius (between 35.6 and 46.4 Fahrenheit).”

About hospitals and healthcare systems

HHS will consider medical debt practices when making grant decisions “Service providers may be asked to provide information about their medical bill collection practices, patient litigation, financial aid, financial product offerings, and practices for contracting with third parties or foreclosing debts. 
HHS will use this information to make grant decisions. The department will also make some data public and report potential violations to law enforcement.”
This measure is part of this announcement: Harris says White House will seek to ease Americans' medical debt burden Much else in the press release has been previously discussed, like The No Surprises Act.

 FAIR SHARE SPENDING, How much are hospitals giving back to their communities?  From the Lown Institute: “The Institute calculated “fair share spending” for more than 1800 hospitals across 275 nonprofit hospital systems by comparing each system’s spending on charity care and community investment to the value of its tax exemption…
KEY TAKEAWAYS

  • Out of 275 nonprofit hospital systems evaluated, 227 spent less on charity care and community investment than the estimated value of their tax breaks — what we call a “fair share deficit.”

  • The total fair share deficit for these 227 hospital systems amounted to $18.4 billion in 2019.

  • The ten systems with the largest deficits account for $5.6 billion (30%) of the total fair share deficit. Many of these systems also received hundreds of millions from the CARES Act in 2020 and ended the year with high net incomes.

  • In seven states, the total fair share deficit for all hospitals exceeded $1 billion (CA, PA, NY, OH, IL, MI, MA).” 

Read the report for hospital and state-level details.

United States Files Suit Against Methodist Le Bonheur Healthcare And Methodist Healthcare-Memphis Hospitals “The United States today filed a complaint in intervention alleging violations of the False Claims Act (FCA) and the Anti-Kickback Statute (AKS) by Methodist Le Bonheur Healthcare (MLH) and Methodist Healthcare Memphis Hospitals (collectively, Methodist), for paying unlawful kickbacks to West Clinic, P.C. (West) in exchange for West’s patient referrals, announced U.S. Attorney Mark H. Wildasin for the Middle District of Tennessee.”
Read this Justice Department press release. The damages for Medicare and Medicaid are claimed to be more than $800M!

About pharma

 The top 20 pharma companies by 2021 revenue “Of the world’s top 20 pharmas ranked by 2021 revenues, 12 had at least 10% growth, including five that saw their sales boom at least 40%.
No company pulled in more revenue from COVID products than Pfizer. Fueled by Comirnaty, Pfizer nearly doubled its top line.
Johnson & Johnson needed a healthy 14% increase in revenue to stay comfortably in front of Pfizer and remain in the top spot, where it has resided since 2012. But that reign is in jeopardy this year, as Pfizer is projecting combined sales of $54 billion from Comirnaty and its oral COVID-19 treatment, Paxlovid.”
See the article for the full list. 

US jury sides with Seagen in Enhertu patent case against Daiichi Sankyo “Seagen announced Friday that it has been awarded close to $42 million in a lawsuit against Daichi Sankyo involving the breast cancer treatment Enhertu (trastuzumab deruxtecan). A federal jury for the Eastern District of Texas found that Daiichi Sankyo, which is partnered on the antibody-drug conjugate (ADC) with AstraZeneca, infringed Seagen's patent on technology that delivers chemotherapy drugs directly to cancer cells. Jurors also rejected arguments that the patent is invalid because it does not cover a novel invention.”

Walgreens and Other Companies Headed to Opioid Trial “A federal judge has given the go-ahead for the San Francisco county and city to take Walgreens and several pharmaceutical companies to trial on April 25 for alleged violations relating to the sale and distribution of opioids…
In the complaint, filed in December 2018, San Francisco charged the defendants with false advertising, negligence, negligent misrepresentation and fraudulent concealment, among other alleged violations.”

Pfizer announces acquisition of Australian digital health company “Pfizer has announced it will acquire ResApp Health (ASX:RAP) in an acquisition that values the Australian digital health company at $100 million.
ResApp has developed smartphone applications that support the diagnosis and management of respiratory disease.
Its machine learning algorithms use sound to diagnose and measure the severity of respiratory conditions without the need for additional accessories or hardware.
Its ResAppDx is an approved smartphone-based acute respiratory disease diagnostic test for use in telehealth, emergency department and primary care settings. Its SleepCheck smartphone application allows consumers to self-assess their risk of sleep apnoea.”

CVS settles with Justice Department to make vaccine scheduling more accessible “CVS has agreed to make its COVID-19 vaccine registration website accessible for people with disabilities as part of a settlement with the Justice Department. 
In an April 11 statement, the Justice Department said CVS will conform its web content about COVID-19 vaccines to the Web Content Accessibility Guidelines, a set of voluntary industry guidelines for making website information accessible to those with disabilities. 
The Justice Department said it found the company's vaccine registration portal was not accessible to people who use screen reader softwares or have trouble using a mouse.”

UK launches world-first ‘subscription’ model for antibiotic supply “The UK is set to become the first country in the world to pay drug companies a fixed fee for supplying antibiotics in an effort to tackle the growing global crisis over resistance to the drugs. The aim is to give companies a better incentive to develop new antibiotics, which would be held back to treat patients who really need them, while restraining overprescribing that leads microbes to develop drug resistance…
Under the deal being struck by the NHS with Pfizer of the US and Shionogi of Japan, the drug companies will be paid a fixed fee of £10mn a year. The current reimbursement system based on sales volume often fails to provide sufficient revenue to justify research and development spending.
The contract value was set at a level that would give international companies an incentive to invest in antibiotic research and development, if other countries pay proportionate sums scaled to their gross domestic product.”

About the public’s health

 One HPV vaccine dose prevents cervical cancer - WHO “A single dose of human papillomavirus (HPV) vaccine is enough to protect against cervical cancer, a World Health Organization group of experts has said.
At the moment, two- or three-dose regimens are recommended, but the WHO's Strategic Advisory Group of Experts on Immunization said the evidence showed that one dose was as effective.”

Weekly U.S. Influenza Surveillance Report Some highlights from the CDC report:

—”The number of hospital admissions reported to HHS Protect has increased each week for the past nine weeks.
—The cumulative hospitalization rate in the FluSurv-NET system is higher than the rate for the entire 2020-2021 season, but lower than the rate seen at this time during the four seasons preceding the COVID-19 pandemic.
—Two influenza-associated pediatric deaths were reported this week. There have been 16 pediatric deaths reported this season.
—CDC estimates that, so far this season, there have been at least 3.8 million flu illnesses, 38,000 hospitalizations, and 2,300 deaths from flu.”

Black Americans’ Views of and Engagement With Science “Relatively few Black adults believe that Black people have reached the highest levels of success as scientists (36%) or engineers (43%); a 55% majority say Black people have reached this level of success as medical doctors.
By contrast, large majorities of Black adults say Black people have reached the highest levels of success as professional athletes (84%) and musicians (80%). Six-in-ten say they have done this as lawyers and 58% say they have done this in the clergy…
Most Black adults say they have either a great deal (28%) or a fair amount (50%) of confidence in medical scientists to act in the public’s best interests. About two-in-ten (21%) say they have not too much or no confidence in medical scientists.
Black Americans’ trust in medical scientists, as well as that for scientists, fell over the past year, as it also did among the general public. Even so, Black Americans’ trust in medical scientists is greater than that for other major groups and institutions including the military, K-12 public school principals and religious leaders…
The legacy of egregious medical misconduct in the U.S. Public Health Service Syphilis Study at Tuskegee, commonly known as the Tuskegee syphilis study, continues to resonate widely among Black Americans. Three-quarters of Black Americans say they have heard a lot (49%) or a little (26%) about the federal government’s study on syphilis, which withheld treatment from Black men, leading to preventable deaths and a worsening of symptoms among those study participants.”

About healthcare IT

 Expiration Date of Tender Offer for Cerner Corporation Shares Extended to May 11, 2022 The headline is the story.

About health technology

 Fitbit Gets FDA Clearance for AFib Detection Feature “Fitbit has received clearance from the US Food and Drug Administrationfor its atrial fibrillation detection algorithm, Google said Monday. 

The technology, which Google says will be coming soon to a range of heart-rate-enabled devices, passively assesses your heartbeat rhythm. If it comes across anything that suggests AFib, it will then alert you through the Irregular Heart Rhythm Notifications feature. 
Google earned clearance for the AFib-detecting technology partly because of a 2020 Heart Study which monitored over 455,000 participants for five months. The study found that Fitbit detected and correctly identified AFib episodes 98% of the time, when compared to ECG patch monitors.”

Today's News and Commentary

About Covid-19

 Covid Could Be Surging in the U.S. Right Now and We Might Not Even Know It “According to the CDC, the majority of the country is still considered low risk. Public health experts argue this is misleading though, given hospitalization and death generally occur days to weeks after initial infection. Without widespread testing, that could make it impossible to detect a surge until it’s too late to do anything about it.”

 Interpretive Summary for April 8, 2022 From the CDC: “As of April 6, 2022, the current 7-day moving average of daily new cases (26,596) increased 4.9% compared with the previous 7-day moving average (25,363). A total of 80,111,065 COVID-19 cases have been reported in the United States as of April 6, 2022.
CDC Nowcast projections* for the week ending April 2, 2022, estimate the combined national proportion of lineages designated as Omicron to be 100%.”

Philadelphia brings back mask indoor mandate as covid cases rise “Public health officials in Philadelphia announced on Monday that the city’s indoor mask mandate would return beginning April 18 as coronavirus cases there rise, making it the first major U.S. city to reinstate a mask mandate this spring.”

Biden official: Mask mandate for airplanes could be extended “Extending the federal transportation mask mandate that applies to airplanes, buses and trains is ‘absolutely on the table,’ Ashish Jha, the White House's new COVID-19 response coordinator, said Monday on the Today Show.
The transportation mask mandate was extended last month but is currently set to expire on April 18.”

White House tells agencies to delay vaccine mandate after court win ”The White House told federal agencies Thursday to hold off on reinstating a coronavirus vaccination mandate for millions of employees, hours after an appeals court rejected an earlier injunction that had blocked the executive order.
In a message to agency officials, the White House cautioned that ‘there are still procedural steps that need to take place to lift the injunction; at this time the district court’s preliminary injunction remains in effect.’”

About health insurance

 Medicare Index Report for 2022 CoverageHighlights:
Medicare Advantage and Part D plan enrollees are paying more in 2022, but premiums remain low - $6 per month is the average Medicare Advantage premium for plans selected by eHealth shoppers, up from $5 last year; $22 is the average Part D plan premium, up from $20 last year.
—Annual deductibles are higher for 2022 – Medicare Advantage enrollees are paying deductibles 4% higher than last year ($121 vs. $116) while Part D plan enrollees have deductibles 7% higher than last year ($427 vs. $400).
—Out-of-pocket limits are lower this year – The average annual out-of- pocket limit for people selecting Medicare Advantage plans decreased 5%, from $5,367 in 2021 to $5,108 for 2022.
—Zero-dollar Medicare Advantage plans remain popular – 87% of beneficiaries selecting Medicare Advantage products at eHealth chose plans with a $0 monthly premium during the Annual Enrollment Period.”

MedPAC Discusses Ambulatory Setting Payment, Social Determinants of Health, and APMs “The Medicare Payment Advisory Commission (MedPAC) met on April 7 and 8 to discuss a variety of policy issues, including recommendations to align fee-for-service payment rates across ambulatory settings, Medicare policy options for addressing social determinants of health (SDOH), and harmonizing Medicare’s portfolio of alternative payment models (APMs). The commission also discussed Medicare drug prices and Part D plan policy. These topics will be included in MedPAC’s June 2022 report to Congress.”
See the article for more details.

UnitedHealth makes $100M investment in affordable housing “UnitedHealth Group has invested an additional $100 million in affordable housing initiatives.
This latest funding brings the company's total investment in affordable housing to nearly $800 million, which has led to the creation of 19,000 housing units for individuals and families. More than 1,000 units will be established as a result of the latest investment.
UnitedHealth's housing investments are a part of the Health & Housing Fund, launched in partnership with Stewards of Affordable Housing for the Future (SAHF) and the National Affordable Housing Trust (NAHT).”

About hospitals and healthcare systems

 St. Helena Clear Lake Hospital v. Xavier Becerra, No. 21-5117 (D.C. Cir. 2022) From the US Court of Appeals for the District of Columbia Circuit: “Appellant, a California critical access hospital, sought Medicare reimbursement for the cost of keeping specialty doctors on call. Under the federal Emergency Medical Treatment and Active Labor Act, hospitals providing emergency room service must stabilize patients before releasing them or transferring them to another hospital. Additionally, California law requires all hospitals to perform certain procedures, including surgery. Appellant claims that it cannot comply with both state and federal law unless it can pay on-call compensation to specialists in surgery, obstetrics, pediatrics, and cardiology.
Affirming the district court’s ruling, the D.C. Circuit held that Appellant is not entitled to Medicare reimbursement for the cost of keeping various specialty doctors on call. Appellant’s federal obligation to stabilize patients before release does not necessarily imply the need for various specialists. Thus, the Provider Reimbursement Review Board (“the Board”) reasonably concluded that Appellant had the ability to stabilize patients with existing emergency room physicians and that specialists were not required to be on call.
Regarding Appellant’s state obligations, the Board’s conclusion that Appellant could satisfy the requirements by keeping a physician with surgical training on-site was reasonable.”

About pharma

 FDA Begins Unannounced Inspections in India “The FDA has begun a pilot program of unannounced inspections of drug manufacturing facilities in India, according to Judith McMeekin, FDA associate commissioner for regulatory affairs.
But the agency has not yet begun unannounced inspections in China, which were also anticipated as part of the pilot…
In the past, the agency has avoided unannounced foreign inspections because of logistical obstacles, such as unreliable transportation in remote areas and the need to be escorted while doing inspections in restricted economic zones.”

About health technology

 Diagnostic Performance of Electronic Nose Technology in Sarcoidosis “The electronic nose (eNose) technology profiles volatile organic compounds in exhaled breath and has potential as a point-of-care diagnostic tool…
Patients with sarcoidosis can be distinguished from ILD [interstitial lung disease] and healthy control subjects by using eNose technology, indicating that this method may facilitate accurate diagnosis in the future. Further research is warranted to understand the value of eNose in monitoring sarcoidosis activity.”
Comment: I gave a presentation at the Technion in Haifa, Israel in 2007. At that conference, another presenter talked about using volatile exhaled chemicals to diagnose a variant of diseases. Sometimes science progresses very slowly. 

Today's News and Commentary (Copy)

About Covid-19

 Congress breaks for recess with $10B COVID-19 aid in limbo “U.S. lawmakers began their two-week recess without acting on a $10 billion COVID-19 relief package, which was agreed to by Senate negotiators and then blocked by Republican lawmakers the next day.  
Senate negotiators agreed to a $10 billion COVID-19 aid package April 4, repurposing earlier unused COVID-19 funds. A day later, the legislative package was complicated by conflict over President Biden's immigration policy, with Republican senators calling for a vote on an amendment that would keep in place the Title 42 border restrictions, which allows limits on immigration due to the pandemic. The bill can't proceed without the vote, they say.”

Impact of U.S. COVID-19 Vaccination Efforts: An Update on Averted Deaths, Hospitalizations, and Health Care Costs Through March 2022 An update from the Commonwealth Fund: “Through March 2022, we estimate that COVID-19 vaccination efforts in the U.S. prevented over 2 million deaths and 17 million hospitalizations... There would have been an estimated 66 million additional infections and nearly $900 billion in associated health care costs in the absence of vaccination.”

Federal appeals court upholds Biden vaccine mandate for federal workers “A federal appeals court on Thursday ruled to uphold the Biden administration’s vaccine mandate for federal workers, ordering that a preliminary injunction issued against the requirement be eliminated.
The 5th Circuit Court of Appeals’s 2-1 ruling reversed an earlier ruling by U.S. District Judge Jeffrey Brown, a Trump appointee in Texas, who in January blocked the mandate for federal workers. The 5th Circuit Court further ordered that the district court dismiss the case.
Judge Carl Stewart, writing for the majority opinion, said plaintiffs in the case could have challenged the vaccine mandate through the federal government’s internal process for federal workers.”

About health insurance

Medicare finalizes its restrictions on new Alzheimer’s drug, despite pressure from drugmakers “Medicare on Thursday finalized its plan to restrict coverage for the controversial, pricey Alzheimer’s drug Aduhelm to patients participating in clinical trials.
The decision marks the end of an intense pressure campaign from drugmakers and some patient groups who wanted Medicare to reverse its initial proposal and pay for the drug for more patients. As clinical trials are usually run out of major medical centers, the decision will likely mean some interested patients won’t be able to access the drug. However, Medicare isn’t explicitly requiring that patients be treated at hospital-based clinics like the initial proposal.”

CVS sells off health savings account arm PayFlex “CVS Health is selling off its health savings account business PayFlex to Millennium Trust, a bank that already offers retirement and financial services, but wants to expand into healthcare and benefits accounts.
PlayFlex covers 2.4 million members and 2,500 clients. With the deal, Millennium will reach 5 million individual client accounts and $47 billion in assets under administration.”

What if the American Rescue Plan Act Premium Tax Credits Expire? Another prediction/update on the impact of the tax credit expiration from the RWJ Foundation:
”Key Findings

  • Over 3 million more people (3.1M) could be uninsured in 2023 if the PTCs expire at the end of 2022, as planned.

  • Non-Hispanic Black individuals, young adults, and people with incomes between 138 and 400 percent of the federal poverty line would experience the largest coverage losses.

  • Individuals and families enrolled in the Marketplaces or other nongroup coverage will pay hundreds of dollars more per person each year in premiums if the PTCs expire. People currently eligible for PTCs with incomes between 150 and 400 percent of the federal poverty level would pay over $1,000 more per person for a silver plan. People with incomes above 400 percent of the federal poverty level who lose eligibility would pay roughly $2,000 more per year.

  • Extending the enhanced PTCs will increase the federal deficit by $305 billion over 10 years, unless legislation extending the PTCs includes raising revenue.

About hospitals and healthcare systems

 M&A Quarterly Activity Report: Q1 2022 From KaufmanHall: “The size of the transactions was smaller than usual and represented a departure from what we have seen during most of the pandemic. For all of 2021, the average size of the seller or smaller party to the transaction reached a historic high of $619 million, driven by the highest percentage of mega transactions seen in the past six years. For Q1 2022, average size of the smaller party was $246 million (Figure 2). In addition to the four transactions with smaller party revenues below $100 million, another six had revenues between $100 million and $500 million, and two had revenues between $500 million and $1 billion.”
The number of mergers and acquisitions is the lowest of any first quarter since tracking started in 2016.

About the public’s health

 U.S. life expectancy continued to drop in 2021, new analysis shows “Life expectancy in the United States, which declined dramatically in 2020 as the coronavirus slammed into the country, continued to go down in 2021, according to a new analysis that shows the United States faring worse during the pandemic than 19 other wealthy countries — and failing to see a life expectancy rebound despite the arrival of effective vaccines.
The study, written by public health experts in Colorado, Virginia and D.C. and posted online but not yet peer-reviewed, found that the continued decline in life expectancy in 2021 came largely among White Americans.” 

Fertility Rates: Declined for Younger Women, Increased for Older Women “The analysis, which looked at Census Bureau and National Center for Health Statistics data, shows fertility rates of women ages 20-24 declined by 43%, while those of women ages 35-39 increased by 67% during the roughly 30-year period.”

About healthcare personnel

 Nurse Practitioner, No. 1 Ranked Health Care Job, Reports Increase in Numbers “The American Association of Nurse Practitioners® (AANP) today released new data showing the current number of nurse practitioners (NPs) licensed to practice in the United States has risen to more than 355,000, an increase of 9% from the estimated 325,000 reported in May 2021…
 By 2026, the U.S. Bureau of Labor Statistics projects that the NP role will have grown by 36%.” 

About healthcare finance

 Pfizer boosts respiratory drug portfolio with ReViral purchase “Pfizer Inc said on Thursday it would buy privately-held ReViral Ltd in a deal worth as much as $525 million including milestone payments, to gain access to experimental drugs against the respiratory syncytial virus (RSV).
The deal marks the U.S. drugmaker's second acquisition in less than six months to boost its drug portfolio, after a $6.7 billion takeover of Arena Pharmaceuticals in December.”

AmerisourceBergen launches $150M venture fund for emerging healthcare companies “The wholesale giant's new VC fund, called AB Health Ventures, will initially look to invest in early to midstage health-related startups both in the U.S. and abroad. The fund will prioritize investments in startups focused on innovation in pharmacy and distribution, clinical development and commercialization of pharmaceuticals, practice solutions for healthcare providers and animal health, executives said in a press release.”

Today's News and Commentary

About Covid-19

Eligible Individuals Can Receive Second COVID-19 Booster Shot at No Cost CMS “announced it will pay for a second COVID-19 booster shot of either the Pfizer-BioNTech or Moderna COVID-19 vaccines without cost sharing… People with Medicare pay nothing to receive a COVID-19 vaccine and there is no applicable copayment, coinsurance or deductible. People with Medicaid coverage can also get COVID-19 vaccines, including boosters, at no cost.”

 FcγR-mediated SARS-CoV-2 infection of monocytes activates inflammation This Nature article explains the cause of the virus’ severe inflammatory action.
”These findings taken together suggest that antibody-mediated SARS-CoV-2 uptake by monocytes/macrophages triggers inflammatory cell death that aborts production of infectious virus but causes systemic inflammation that contributes to COVID-19 pathogenesis.” 

Risks of deep vein thrombosis, pulmonary embolism, and bleeding after covid-19: nationwide self-controlled cases series and matched cohort study The clotting/bleeding problems of hospitalized patients with the virus are well-known. This research investigated the longer-term complication rates.
”Compared with the control period, incidence rate ratios were significantly increased 70 days after covid-19 for deep vein thrombosis, 110 days for pulmonary embolism, and 60 days for bleeding…
These results could impact recommendations on diagnostic and prophylactic strategies against venous thromboembolism after covid-19.”

About health insurance

 Florida’s BayCare Health System and Hospital Affiliates Agree to Pay $20 Million to Settle False Claims Act Allegations Relating to Impermissible Medicaid Donations  This case is a good example of a prohibited Medicaid funding activity.
”BayCare Health System Inc. and entities that operate four affiliated Florida hospitals (collectively BayCare) have agreed to pay the United States $20 million to resolve allegations that BayCare violated the False Claims Act by making donations to the Juvenile Welfare Board of Pinellas County (JWB) to improperly fund the state’s share of Medicaid payments to BayCare. The four hospitals are Morton Plant Hospital, Mease Countryside Hospital, Mease Dunedin Hospital and St. Anthony’s Hospital.
The Florida Medicaid program provides medical assistance to low-income individuals and individuals with disabilities, and is jointly funded by the federal and state governments. Under federal law, Florida’s share of Medicaid payments must consist of state or local government funds, and not “non-bona fide donations” from private health care providers, such as hospitals. A non-bona fide donation is a payment — in cash or in kind — from a private provider to a governmental entity that is then returned to the private provider as the state share of Medicaid. The private provider’s donation triggers a corresponding federal expenditure for the federal share of Medicaid, which is also paid to the private provider. This unlawful conduct causes federal expenditures to increase without any corresponding increase in state expenditures, since the state share of the Medicaid payments to the provider comes from and is returned to the provider. The prohibition of this practice ensures that states are in fact paying a share of Medicaid payments and thus have an incentive to curb Medicaid costs and prevent unnecessary services.”

Optum, Change Healthcare set $650M merger reversal fee, extend agreement through 2022 “Optum and Change Healthcare are extending their merger agreement through the end of 2022 and setting a $650 million reversal fee if the deal isn't successful…
In a joint statement, the companies said, "The extended agreement reflects our firm belief in the potential of our combination to improve health care, and in our commitment to contesting the meritless legal challenge to this merger."
Optum, a subsidiary of UnitedHealth Group, first announced its intention to acquire Nashville, Tenn.-based Change Healthcare for $13 billion in January 2021.”

CMS proposes indefinite delay for Radiation Oncology model already postponed by Congress “The radiation oncology mandatory payment model is intended to reimburse oncology practices and hospital outpatient sites for total episodes of care and will make site-neutral payments for certain radiation therapies. 
But the model has generated major pushback from the oncology industry. The advocacy group Community Oncology Alliance said last August the mandatory model’s cuts will hurt oncology practices already under strain from the pandemic. 
The alliance had asked the model to be pushed back to 2023 and the cuts to be stopped. Congress agreed and passed legislation back in December to delay the start date from Jan. 1, 2022, to 2023.”

About hospitals and healthcare systems

 The National Imperative to Improve Nursing Home Quality: Honoring Our Commitment to Residents, Families, and Staff This book is now the standard on this topic. In brief:
”The Committee on the Quality of Care in Nursing Homes was charged with examining the ways in which the United States currently delivers, finances, measures, and regulates the quality of nursing home care. After a thorough review of the evidence, the committee arrived at seven overarching conclusions.”
The first conclusion drives the recommended actions:
“First, the way in which the United States finances, delivers, and regulates care in nursing home settings is ineffective, inefficient, fragmented, and unsustainable.”

About pharma

 Judge rules AIG, Chubb not obligated to defend McKesson in opioid cases  “A federal court judge in California has ruled that insurers AIG and Chubb are not obligated to pay defense costs for healthcare company McKesson, on the basis that policies issued by the carriers do not provide coverage for the massive settlements it has reached to settle its liability for costs ...”

National trends in prescription drug expenditures and projections for 2022 “In 2021, overall pharmaceutical expenditures in the US grew 7.7% compared to 2020, for a total of $576.9 billion. Utilization (a 4.8% increase), price (a 1.9% increase) and new drugs (a 1.1% increase) drove this increase. Adalimumab was the top drug in terms of overall expenditures in 2021, followed by apixaban, and dulaglutide. Drug expenditures were $39.6 billion (a 8.4% increase) and $105.0 billion (a 7.7% increase) in nonfederal hospitals and in clinics, respectively. In clinics and hospitals, new products and increased utilization growth drove growth, with decreasing prices for both sectors acting as an expense restraint. Several new drugs that are likely to influence spending are expected to be approved in 2022. Specialty and cancer drugs will continue to drive expenditures along with the evolution of the COVID-19 pandemic.
Conclusion For 2022, we expect overall prescription drug spending to rise by 4.0% to 6.0%, whereas in clinics and hospitals we anticipate increases of 7.0% to 9.0% and 3.0% to 5.0%, respectively, compared to 2021.”

About the public’s health

 Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication  From the FDA: “The U.S. Food and Drug Administration (FDA) is updating the April 2020 Safety Communication to provide new information supporting the transition to fully disposable duodenoscopes and those with disposable components as well as new information on completed postmarket surveillance studies…
Given the cleaning concerns and contamination data with fixed endcap duodenoscopes and the increasing availability of duodenoscope models that facilitate or eliminate the need for reprocessing, hospitals and endoscopy facilities should complete transition to innovative duodenoscope designs that include disposable components such as disposable endcaps, or to fully disposable duodenoscopes.”

2022 Building H Index “The 2022 Building H Index ranks 37 companies in four industries – entertainment, food, housing and transportation – on how their products and services impact the health of their customers and consumers. The ranking reflects how companies score across five health-related behaviors: healthy eating, physical activity, sleep, social engagement, and time spent outdoors.” The bottom 5 are all streaming services.

About health technology

 Law groups, professors lash out against Thermo Fisher in suit over the 'immortal cells' of Henrietta Lacks “It’s been decades since medical researchers at Johns Hopkins unethically took tissue samples from Henrietta Lacks and used them to create the world’s first known “immortal” cell line.
Now, Thermo Fisher is looking to evade a lawsuit claiming it continues to profit from the cells without permission from Lacks’ estate…
Three amici curiae, or ‘friend of the court,’ briefs were filed on Tuesday against Thermo Fisher’s motion to dismiss all claims against itself…
Lacks’ estate filed a complaint back in 2021 seeking, among other stipulations, profits from the commercialization of the cell line, and an order barring the company from using the cells without permission.”

Today's News and Commentary

About Covid-19

Covid deal hampered by GOP opposition to Biden immigration policy “Just a day after Republican Sen. Mitt Romney and Majority Leader Chuck Schumer announced a deal on billions for therapeutics, vaccines and testing, GOP senators threw in a wrench that could mean Congress will break with nothing. Senate Republicans say they want a vote on an amendment that would keep in place the Title 42 border restrictions, which allows limits on immigration due to the pandemic. Without one, they say the bill can’t proceed.”

HRSA says it will reopen pandemic relief reporting to providers with 'specific extenuating circumstances' “Following industry outcry, the Health Resources and Services Administration is now planning to give another chance to providers who were unable to report on COVID-19 pandemic assistance “as a result of specific extenuating circumstances,” according to a notice recently added to the Provider Relief Funding Reporting Requirements and Auditing page of the agency’s website.
HRSA’s notice did not detail which circumstances will qualify providers for the new reporting window…
The update came shortly after a report from Bloomberg Law that the administration planned to claw back up to $100 million in Provider Relief Fund assistance from those who didn’t meet reporting requirements.”

FDA updates Sotrovimab emergency use authorization “Update [4/5/2022] Sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion of COVID-19 cases caused by the Omicron BA.2 sub-variant.”

FDA says Covid vaccines may need to be updated to ensure high level of effectiveness against virus ”The currently approved Covid-19 vaccines may need an update to ensure a high level of protection as the virus continues to evolve, according to the Food and Drug Administration.
The FDA, in a briefing document published ahead of an advisory committee meeting this week, said scientists still don’t entirely understand Covid variants and the effectiveness of the vaccines. For example, mutations to the spike protein, which is used by the virus to invade human cells, have reduced effectiveness of current vaccines. That’s because today’s Covid shots were developed to target the spike protein in the original strain of the virus that emerged in Wuhan, China in late 2019.”

Heart issues more common after Covid infection than vaccination, CDC reports “Compared to vaccination, Covid-19 itself is far more likely to lead to heart problems in teenage boys and young men, the Centers for Disease Control and Prevention reported…”

Protection by a Fourth Dose of BNT162b2 against Omicron in Israel “Rates of confirmed SARS-CoV-2 infection and severe Covid-19 were lower after a fourth dose of BNT162b2 vaccine than after only three doses. Protection against confirmed infection appeared short-lived, whereas protection against severe illness did not wane during the study period.”

About health insurance

 Optum continues buying spree and scoops up Houston-based Kelsey-Seybold Clinic: report “With more than 500 physicians, Kelsey-Seybold Clinic operates multi-specialty care centers, a cancer center, a women’s health center, two ambulatory surgery center locations, and a specialized sleep center with more than 30 locations in the Greater Houston area. Kelsey-Seybold partners with major insurers to offer value-based commercial health plans. Kelsey-Seybold partners with major insurers to offer value-based commercial health plans…
In early 2020, TPG Capital, the private equity platform of global alternative asset firm TPG, made a minority investment in Kelsey-Seybold. At the time of the investment, the medical group's valuation was estimated to be $1.3 billion…”
Comment: Since Optum is a division of UnitedHealth Group, it remains to be seen what other insurers will do about their Clinic contracts.

Association of Maryland Global Budget Revenue With Spending and Outcomes Related to Surgical Care for Medicare Beneficiaries With Cancer Question  Is the Maryland global budget revenue (GBR) model associated with meaningful changes in 30-day episode spending and clinical outcomes among Medicare beneficiaries who undergo cancer-directed surgery?
Findings  In this difference-in-differences analysis, comparison of Maryland Medicare beneficiaries with a matched control group found that GBR was associated with a statistically significant decrease in 30-day readmissions. However, we found no consistent changes in 30-day episode spending, emergency department visits, or all-cause mortality.”

About hospitals and healthcare systems

 Payer mix in the nation's top 20 hospitals FYI: “The 2019 data released April 5 is from the coverage, cost and value team at the National Academy for State Health Policy in collaboration with Houston-based Rice University's Baker Institute for Public Policy.”

About pharma

 Therapeutic Value Assessments of Novel Medicines in the US and Europe, 2018-2019 “…the accelerated approval (AA) program permits the FDA to approve novel drugs for serious or life-threatening diseases on the basis of changes to surrogate measures that only are reasonably likely to predict clinical benefit. Surrogate measures are laboratory values that can be observed faster than clinical end points but may not accurately estimate how a patient feels, functions, or survives. The analogous approval pathway in the European Union (EU) is the conditional marketing authorization (CMA). Special designations in the US and Europe are also available for drugs addressing rare diseases and promote regulatory flexibility when evaluating the evidence….
we found that less than one-third of novel drugs approved by the FDA and EMA in recent years had high added therapeutic value. These results are consistent with a previous study focusing on drugs approved until 2017. None of the AA or CMA drugs had high added therapeutic benefits. Because we examined only drugs approved in 2018 to 2019, our results may not be generalizable to drugs approved in earlier years. The fact that so few of the expedited drugs or those for rare diseases had a high added therapeutic value supports the need for more scrutiny about which drugs qualify for these programs.”

FDA Clinical Trial Guidances Share Biden Administration’s Goals for Advancing Development of Cancer Treatments “The first guidance, “Inclusion of Older Adults in Cancer Clinical Trials,” provides recommendations to sponsors and institutional review boards for including older adult patients, aged 65 years and older, in the clinical trials of drugs for the treatment of cancer…
The second guidance for industry “Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics,” provides advice on designing and conducting trials with multiple expansion cohorts that allow for concurrent accrual of patients into different cohorts to assess safety, pharmacokinetics, and anti-tumor activity of first-in human cancer drugs…
Finally, the “Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics” guidance addresses master protocol design including information on what sponsors should submit to the FDA as part of these trial design approaches. It also directs how sponsors should interact with the FDA to facilitate efficient review and mitigate risks to patients.”

About the public’s health

 Health and Health Care for Women of Reproductive Age From the Commonwealth Fund:
”Highlights:

  • Among women of reproductive age in high-income countries, rates of death from avoidable causes, including pregnancy-related complications, are highest in the United States.

  • U.S. women of reproductive age are significantly more likely to have problems paying their medical bills or to skip or delay needed care because of costs.

  • U.S. women of reproductive age have among the highest rates of multiple chronic conditions and the highest rate of mental health needs.

  • Sweden, the U.S., Canada, and Australia are the countries where women of reproductive age are the least likely to report having a regular doctor or place to go for care.”

    Comment: It is interesting to note that having a regular doctor is not solely a function of the national insurance scheme. 

Medical bills for US shooting survivors top $2.5B in 1st year after injury, study says “In the first year after a firearm injury, gunshot survivors spent on average $2,495 more in healthcare per month than those who did not suffer gunshot wounds. When extended to all gunshot survivors in the U.S., direct healthcare spending amounts to $2.5 billion in the first year. Cost-sharing, including copays and deductibles, is $102 more per person per month for gunshot survivors. 
The largest healthcare spending increases were found during the first month after injury, reaching on average $25,554 per person in spending and $1,112 per person in cost-sharing.
Each year, gun violence kills nearly 40,000 people in the U.S. and costs the nation $280 billion, including medical, criminal justice and quality-of-life expenses.”

EPA moves to ban the most common type of cancer-causing asbestos “The Environmental Protection Agency on Tuesday proposed to ban chrysotile asbestos, the most common form of the toxic mineral still used in the United States.
Also known as ‘white asbestos,’ it has remained on the market despite decades of research showing that it is a deadly carcinogen, linked to about 40,000 U.S. deaths each year. Chlorine manufacturers and companies that make vehicle braking systems and sheet gaskets still import chrysotile asbestos and use it to manufacture new products.
The proposed rule would ban all manufacturing, processing, importation and commercial distribution of six categories of products containing chrysotile asbestos, which agency officials said would cover all of its current uses in the United States.”

FDA Gains Power to Regulate Synthetic Nicotine in e-Cigarettes “Closing a loophole in the federal government’s oversight of e-cigarette products, new legislation gives the US Food and Drug Administration (FDA) the authority to regulate synthetic nicotine, used by some e-cigarette makers to evade a ban on flavored e-cigarettes, favored by teen vapers.
The new law will become effective on April 14. Closing the synthetic nicotine loophole is intended to help advance the public health goal of reducing nicotine addiction that US teens acquire through use of flavored e-cigarettes.”

About healthcare finance

 Fitness company Tivity Health to be bought by Stone Point Capital for $2 bln “Fitness company Tivity Health said on Tuesday it had agreed to be bought and taken private by investment firm Stone Point Capital for $2 billion in cash…
The company owns SilverSneakers, a fitness program offered in-person and virtually for people eligible for Medicare - the U.S. government's medical insurance program for people age 65 and older and the disabled.”

Healthcare not as ‘recession-proof’ as expected, analysts say “Healthcare corporations are at increased danger of defaulting on their loans than many different industries, a brand new report signifies. 
The healthcare {industry} had the very best chance to default over the subsequent yr at a 4.4% median, first-quarter S&P Global Market Intelligence data evaluating U.S. sectors present. That likelihood was up from 3.3% as of the top of final yr, in response to S&P’s evaluation, which is predicated on the volatility of share costs for public corporations and country- and industry-related dangers.
‘There was a perception before the pandemic that healthcare was “recession-proof.” But this is a fundamentally different environment,’ mentioned Matt Wolf, director and senior healthcare analyst with RSM. ‘Providers have had to shut down non-emergent procedures, either due to lockdowns or not having the staff to perform them. They’ve paid the staff they do have more while reimbursement levels are not going up. They are not going to hire their way out of this.’”