Today's News and Commentary

About health insurance

Oscar Health Announces Results for Third Quarter 2021: Disturbing trends, especially compared to other insurers’ financials reported here last week. Despite increased membership and premiums, the MLR and net loss increased.

  • “Membership as of September 30, 2021 of 594,284, a 41% increase YoY

  • For the quarter ended September 30, 2021:

    • Direct policy premiums of $895.4 million, a 53.1% increase YoY

    • Premiums earned of $441.7 million, a 345.6% increase YoY

    • Medical Loss Ratio of 99.7%, increased 920 bps YoY

    • InsuranceCo Administrative Expense Ratio of 23.1%, increased 70 bps YoY

    • InsuranceCo Combined Ratio of 122.8%, increased 990 bps YoY

    • Net loss of $212.7 million, an increase of $133.6 million YoY; Adjusted EBITDA loss of $188.7 million, an increase of $117.7 million YoY”

2022 Medicare Parts A & B Premiums and Deductibles/2022 Medicare Part D Income-Related Monthly Adjustment Amounts: CMS says Part B increases will be more than offset by the increased Social Security payments (as if healthcare is the only increased expense facing seniors). One unique item in this year’s explanation of why rates are increasing: “Additional contingency reserves due to the uncertainty regarding the potential use of the Alzheimer’s drug, Aduhelm™…” At $56k per year, the drug’s sales have been slow, but future unknown costs forced CMS to be prepared for huge future expenses. Some estimate that about half of the 14.5% increase in Part B premiums are due to this cost uncertainty. See, also: Alzheimer’s drug cited as Medicare premium jumps by $21.60

Healthcare Affordability: Majority of Adults Support Significant Changes to the Health System: From the RWJ Foundation:
Some highlights:
- “Put limits on what drug companies can charge for specific drugs that save lives or that millions of people use to treat life-long health conditions like diabetes. (89%)

- Prevent drug companies from blocking cheaper generic drugs from being sold in the US. (86%)

- Put limits on the prices that hospitals can charge for services. (85%)

- Allow the government to negotiate lower drug prices for employers and consumers. (84%)

- Put limits on the prices that doctors can charge for services. (81%)

- Eliminate health insurance deductibles and copayments so that people don't have to pay more to use their health insurance. (80%)” One question not asked was whether respondents would rather higher premiums or narrower networks in exchange for a reduction in out-of-pocket expenses.

Former UnitedHealth exec says company would only pay surprise bills after complaints: “The former head of UnitedHealthcare's Shared Savings Program alleged during testimony that the insurer was willing to pay for its members' surprise medical bills, but only if they filed a complaint to the company. 
The testimony is part of the ongoing legal battles between UnitedHealthcare and TeamHealth. John Haben, the former UnitedHealthcare executive, has been testifying in Nevada over a TeamHealth lawsuit that alleges the insurer's Shared Savings Program resulted in millions of dollars in clinician underpayments.”

About Covid-19

U.S. appeals court affirms hold on Biden COVID-19 vaccine mandate: “A U.S. appeals court on Friday upheld its decision to put on hold an order by President Joe Biden for companies with 100 workers or more to require COVID-19 vaccines, rejecting a challenge by his administration.”

About pharma

CVS withdraws Supreme Court case on disability rights, announces new partnership: “The CVS pharmacy chain has reached an agreement with a coalition of disability rights organizations and dropped a legal case that had made it all the way to the U.S. Supreme Court. The court was scheduled to hear arguments in the dispute next month, and the ruling could have had far-reaching effects on disability rights
The case, CVS Pharmacy, Inc. vs. Doe, stemmed from a lawsuit filed against CVS by multiple people who take prescription drugs for HIV/AIDS. The plaintiffs objected to changes to the company's terms that meant they could not opt out of mail-only delivery or utilize another pharmacy with experience handling their special medication needs. They argued it had a discriminatory impact on them, even if that wasn't the company's intent.”
Since the Supreme Court did not have a chance to rule in this case, the issue of the ability of an insurance company to impose a narrow network is unresolved.

About healthcare devices

FDA flags safety issue in replacement material for recalled Philips ventilators: “Months after Philips received the FDA’s go-ahead to begin repairing and replacing the ventilators affected by the Class I recall the company initiated in mid-June, the regulator identified a potential safety risk with a replacement component, according to a Nov. 12 statement.
The recall was sparked by an issue Philips identified with the polyester-based polyurethane foam used to muffle sound and vibrations in its continuous and non-continuous ventilators. Over time, the company found, that foam could break down, potentially sending specks of black debris and other dangerous toxins into the air pathway.”

Today's News and Commentary

About the public’s health

Lifestyle changes could save $92,000 in medical costs per person: “The study examined four individual patient cases of disease reversal achieved through intensive lifestyle changes and the associated reduction in health care costs. A substantial potential cost savings for both the patients and their insurance providers was identified in each case. For an adult male who lost up to 200 pounds after committing to a lifestyle change for six months, the potential savings in avoided discrete medical costs reached $92,000.”

Cervical Cancer Screening Guideline for Individuals at Average Risk: Cervical Cancer Screening for Individuals at Average Risk: 2020 Guideline Update From the American Cancer Society:
Major recommendations:

  • Begin screening at age 25 years regardless of sexual history or HPV vaccination status (strong recommendation) [Increased from age 21]

  • Primary HPV testing every 5 years through age 65 years (strong recommendation) [Increased testing every five years from 3 years.]

  • If primary HPV testing is not available use cotesting (HPV+ cytology) every 5 years or every 3 years if cytology only (strong recommendation)

  • Discontinue screening at age 65 years if no history of cervical intraepithelial neoplasia grade 2 or more severe diagnosis in last 25 years and adequate negative prior screening in last 10 years (qualified recommendation)”

The High Costs of Maternal Morbidity Show Why We Need Greater Investment in Maternal Health: “We identified evidence to support connections between nine maternal morbidity conditions, such as hypertensive disorders, and 24 maternal and child outcomes, such as cesarean section delivery and preterm birth. We estimated total maternal morbidity costs for all U.S. births in 2019 to be $32.3 billion from conception through the child’s fifth birthday. This amounts to $8,624 in additional costs to society for each maternal–child pair.”

About pharma

Johnson & Johnson will break itself into two companies.: “Johnson & Johnson said on Friday that it would break itself into two publicly traded companies…
The 135-year-old company, which employs more than 136,000 people, announced that it planned to spin off its consumer-products division — home to Tylenol, Band-Aid, Neutrogena beauty products and more — into a separate business.
That would leave J.&J. with its pharmaceutical and medical devices division, which includes its coronavirus vaccine manufacturing and boasts faster-growing sales and higher margins.”

Keeping the 100-year-old promise:making insulin access universal: From the WHO:
”In 1921, researchers at the University of Toronto discovered insulin, which changedthe diabetes narrative forever. In keeping with a promise that insulin ‘belongs to the world’, the patent was sold for just one Canadian dollar.” Prices had been affordable with increased production. But more recently, analogue insulins have replaced human insulin and prices have skyrocketed. The result is that about 30 million people worldwide who need insulin do not have access to it.
This monograph offers an excellent examination of what is wrong and how access can be improved.

Biden to Choose Robert Califf to Lead F.D.A., Despite Drug Industry Ties: “President Biden on Friday is expected to nominate Dr. Robert M. Califf, a former commissioner of the Food and Drug Administration, to lead the agency again, several people familiar with the planning said. The move would end nearly a year of political wrangling as the White House vetted then dropped several candidates after complaints that some were too close to the pharmaceutical industry.
In the end, White House officials might have concluded that they could not find a suitable candidate with no industry ties. Dr. Califf, 70, a respected academic and clinical trial researcher who ran the agency during the last year of the Obama administration, has long been a consultant to drug companies and ran a research center at Duke University that received some funding from the drug industry.”

Strengthening the FDA’s Enforcement of ClinicalTrials.gov Reporting Requirements: “Through an ongoing Freedom of Information Act–based investigation, all 58 Pre-Notices that the FDA issued from 2013 through April 29, 2021, were obtained. Of these, 57 described potential missing trial results information and 1 described missing registration information.”
The authors recommend several measures that the FDA can use to make sure companies comply with reporting requirements.

About Covid-19

Booster shots are most popular in poorly vaccinated states where coronavirus rages: “The rate at which fully vaccinated residents are getting the shots is highest in the states that also have high rates of new coronavirus cases, including Alaska, North Dakota and Montana, according to a review of state data by The Washington Post. In swaths of the country where health officials will not impose mask and vaccine mandates to curb the virus’s spread, or have had their powers stripped away by Republican state lawmakers or governors, boosters are one of the few shields left for those worried about contracting and spreading the virus.”

AstraZeneca to take profits from Covid vaccine sales: “AstraZeneca has signed its first for-profit deals for its Covid-19 vaccine, moving away from the completely non-profit model that it used during the pandemic. The Anglo-Swedish drugmaker is now expecting the vaccine will move to ‘modest profitability’ as new orders are received. The shot, developed with the University of Oxford, will remain non-profit for developing countries. AstraZeneca committed to selling the vaccine ‘at cost’ for the duration of the pandemic, as part of its agreement with Oxford.”

About health insurance

6 national payers ranked by Q3 profits: A good summary with links to each company for further information.
All were profitable.

New Spending from Filling the Medicaid Coverage Gap Outweighs Cuts in Disproportionate Share Payments: From the Urban Institute: “This paper provides estimates of the increase in federal subsidies under two provisions of the Build Back Better Act (BBBA) that would flow to people below the federal poverty limit in the 12 states that have not expanded Medicaid (people in the “Medicaid gap”). These subsidies are compared to the cuts in federal DSH payments also proposed in the bill. We estimate that in a year when Medicaid gap subsidies are provided, hospitals in the 12 nonexpansion states would see more than $6.8 billion in new spending for people in the Medicaid gap as a result of the coverage expansions, about 15 times larger than the expected DSH cuts of $444 million. Overall new federal health subsidies for people in the Medicaid gap going to nonexpansion states would be more than $19 billion.”
Two related papers: How would filling the Medicaid “coverage gap” affect hospital finances? from Brookings/USC Schaeffer Center which reaches similar conclusions and an opposing critiques from the AHA: Brookings paper misses the point on Medicaid DSH cuts included in BBBA

CMS nixes Medicare coverage of breakthrough medical devices: 4 things to know: “CMS said Nov. 12 it will rescind a rule introduced by former President Donald Trump's administration that allows Medicare to quickly cover medical devices deemed ‘breakthrough' technologies by the FDA…
CMS said it will rescind the rule because of concerns over Medicare patient safety.
’Although we continue to be in favor of enhancing access to new technologies, we are mindful that they may have unknown or unexpected risks and must first ensure such technologies improve health outcomes for Medicare beneficiaries,’ CMS Administrator Chiquita Brooks-LaSure said…”

About healthcare IT

FCC grants $709M to improve rural broadband access: “The Federal Communications Commission on Nov. 10 announced the fourth round of funding for its Rural Digital Opportunity Fund, awarding $709 million to support the development of high-speed broadband networks for more than 10 million Americans who live in rural areas.”

About healthcare financing

US doctors fear patients at risk as cost cuts follow private equity deals: A concerning expose from The Financial Times concerning cuts in clinical care due to private equity firms reducing expenses in their new healthcare investments.
”Private equity groups have poured money into US healthcare in recent years, as they see opportunity in an ageing society that spends more than ever on staying healthy. According to a report by Richard Scheffler at the University of California, Berkeley, and Laura Alexander at the American Antitrust Institute, annual private equity healthcare deals soared from an estimated $42bn in 2010 to $120bn in 2019, before dipping to $96bn in 2020.”

Today's News and Commentary

About Covid-19

Federal judge overrules Texas ban on mask mandates in schools: “A federal judge ruled Wednesday that Texas Gov. Greg Abbott’s (R) ban on mask mandates in schools violates the Americans With Disabilities Act, a decision that could have national implications as several other states are embroiled in legal battles over face covering requirements for children…
Disability Rights Texas, an advocacy group, challenged the Republican governor’s ban in August, arguing that it discriminates against students with disabilities — many of whom have health conditions that put them at greater risk for severe illness or death — by forcing them to risk exposure to the coronavirus or stay home from school.”
While Texas state officials are trying to prevent disease-controlling measures: Unvaccinated 20 times more likely to die from COVID-19: Texas study: “A Texas government study found that unvaccinated people were 20 times more likely to die of COVID-19 than the fully vaccinated throughout most of September, providing further evidence backing the vaccines. 
The research, published by the Texas Department of State Health Services on Monday, determined that 81.3 percent of COVID-19-related deaths between Sept. 4 and Oct. 1 occurred among unvaccinated people. In comparison, 5 percent of these fatalities occurred among the partially vaccinated, and 13.7 percent involved fully vaccinated patients. 
In that time period, unvaccinated individuals in their 40s were 55 times more likely to die from COVID-19 than others who were the same age and fully vaccinated. Among those aged 75 and older, the unvaccinated were 12 times more likely to die.”

States challenge Biden’s vaccine mandate for health workers: “The lawsuit filed in a federal court in Missouri contends that the vaccine requirement threatens the jobs of millions of health care workers and could “exacerbate an alarming shortage” in health care fields, particularly in rural areas where some health workers have been hesitant to get the shots…
Joining the lawsuit were the attorneys general of Alaska, Arkansas, Iowa, Kansas, Nebraska, New Hampshire, North Dakota, South Dakota and Wyoming. All are Republicans except for Democratic Attorney General Tom Miller of Iowa, whose state is led by Republican Gov. Kim Reynolds.”

Home virus tests recalled over false positives reach 2 million kits.: “The Australian company Ellume has expanded a recall of its at-home coronavirus test because of concerns about a ‘higher-than-acceptable’ rate of false positives, the U.S. Food and Drug Administration said on Tuesday.
The recall now includes roughly two million of the 3.5 million test kits that Ellume had shipped to the United States by last month, a substantial increase from the company’s earlier estimate that about 427,000 of those kits were potentially faulty.
It is not clear how many false positives the affected tests have yielded. The issue, which the company had previously traced to a problem with one of the raw materials used in its test kits, does not affect the reliability of negative results.”

About health insurance

2021 Employer Health Benefits Survey: This annual KFF study is the best single source of information on employer-sponsored insurance. While there are many valuable details in the chapters, the overall message in the press today is: “In 2021, the average annual premiums for employer-sponsored health insurance are $7,739 for single coverage and $22,221 for family coverage. The average single and family premiums increased 4% over the past year. During this period, workers’ wages increased 5% and inflation increased 1.9%.
The average premium for family coverage has increased 22% over the last five years and 47% over the last ten years.”

TransUnion Healthcare: 2021 Sees 55% Rise in Financial Assistance Transactions: “The number of financial assistance transactions processed by TransUnion Healthcare increased 55% between September 2020 and September 2021. A new analysis from TransUnion Healthcare (NYSE: TRU) released at the HFMA Annual Conference indicates hospitals are more proactively working with patients to understand their financial needs and provide them appropriate options…
While the increased number of financial assistance transactions was likely exacerbated by the economic downturn caused by the pandemic… other factors, like hospital billing practices also played a role.”

About pharma

Current and Resolved Drug Shortages and Discontinuations Reported to FDA: The total list has 156 entries, many of which are highly-used drugs, e.g., cefazolin, cefotaxime, dexamethasone, digoxin, dobutamine, and epinephrine. Those medications are just the A through E entries!

Doctor Who Distributed Unapproved Cancer Treatment Drug Convicted of More Than Two Dozen Felony Charges: “A physician has been found guilty of 26 felony charges for fraudulently distributing an unapproved cancer treatment over a six-year period, charging up to $2,000 per bottle, the Justice Department announced today.
Benedict Liao, 81, a.k.a. ‘Wada Masao,’ and ‘Masao A. Wada,’ of Fullerton, was found guilty on Tuesday afternoon of seven counts of wire fraud, 11 counts of selling a misbranded drug and eight counts of selling an unapproved new drug…
From July 2012 through June 2014, Liao sold and distributed Allesgen at a price generally set at $2,000 per bottle, plus shipping, to customers in various states and in foreign countries, because of which he received at least approximately $850,000 in revenue. From approximately July 2014 through January 2018, Liao continued to sell and distribute additional bottles of Allesgen to customers in various states and in foreign countries, as a result of which he received additional revenue totaling approximately $765,000.”
How was he able to sell this substance for 6 years?

Vizient Calls on Industry Stakeholders to Join Alliance to End Drug Shortages: “Vizient, Inc….announced the formation of a new alliance to end drug shortages in the U.S. The End Drug Shortages Alliance will provide a forum for key stakeholders across the industry to take strategic aim at one of the health care industry’s most pressing and enduring issues.
Vizient, which connects more than half the nation's health care organizations to pharmaceutical suppliers through its contracting services, monitors more than $80 billion in pharmaceutical spend across all classes for trade. In 2019, a Vizient member survey revealed that managing drug shortages costs U.S. hospitals more than $359 million annually in labor alone.”

FDA Issues Nearly 50 Product-Specific Guidances for Generics Producer: ““The guidances provide product-specific recommendations on, among other things, the design of bioequivalence studies to support abbreviated new drug applications” (ANDAs), said the agency in a Federal Register notice published Tuesday.
Of the new and updated draft PSGs released, 13 guidances pertain to complex generic products, covering products with a complex active ingredient, formulation, route of delivery or dosage form. And more PSGs on complex generics are expected soon. On its website, the agency lists a further 69 complex generics set to receive draft guidances.”

About hospitals and health systems

100 of the largest hospitals and health systems in America | 2021: FYI

About healthcare quality

Addressing health care disparities by improving quality and safety: A new policy statement from the Joint Commission. Accreditation requirements are listed on page 7.

About healthcare devices

A decade retrospective of medical robotics research from 2010 to 2020: An excellent review of the topic.
A useful overview of the conclusions (with references left in the text): “Although the field cannot yet point to comprehensive clinical trials that show that robotic surgical procedures provide improved procedural outcomes for patients (70) or reduced procedure cost compared with nonrobotic surgery (71), a number of patient benefits have been demonstrated. These include shorter hospital stays, faster recuperation, fewer reoperations, and reduced blood transfusions (71). For surgeons, robots provide improved ergonomics, leading to reductions in neck and back pain (72) as well as hand and wrist numbness (73) with less physical and mental stress compared with direct hand-controlled procedures (74). These factors increase a surgeon’s quality of life and could potentially lengthen their career. Studies have also shown that robotics can markedly reduce radiation exposure to both the surgeon and the patient (75).”



Today's News and Commentary

About health insurance

Association of Participation in the Oncology Care Model [OCM] With Medicare Payments, Utilization, Care Delivery, and Quality Outcomes: “In its first 3 years, the OCM was significantly associated with modestly lower Medicare episode payments that did not offset model payments to participating practices, and there were no significant differences in most utilization, quality, or patient experience outcomes.”
See, also, the accompanying editorial: Medicare Spending, Utilization, and Quality in the Oncology Care Model, which raises some good policy questions.

Whistleblower alleges Aetna used dead, out-of-state physicians to bolster network: “A recently unsealed whistleblower lawsuit out of Philadelphia accuses Aetna of assigning children under Medicaid to providers who were dead, out of state or did not specialize in pediatrics.”

Georgia ASCs, anesthesia providers to pay $28M to resolve kickback allegations: “Three anesthesia providers and several Georgia ASCs, along with their physician-owners and an administrator, agreed to pay more than $28 million to resolve allegations that they entered kickback agreements…
The suit alleges that Ambulatory Anesthesia of Atlanta and Northside Anesthesiology Consultants, both in Atlanta, paid a number of ASCs for medications, supplies, equipment and labor in exchange for patient referrals between 2005 and 2015.”

Clover Health Reports Third Quarter 2021 Financial Results: The company provides an interesting case study. The Medical Loss Ratio is still high as the company has rapidly expanded. It blames Covid-19 rebound of deferred care for the increase costs, but other companies are not reporting such numbers.

About Covid-19

U.S. government to buy $1 billion more worth of Merck's COVID-19 pill: “The U.S. government will buy another $1 billion worth of the COVID-19 pill made by Merck & Co Inc  and partner Ridgeback Biotherapeutics, the companies said on Tuesday.
The government in June agreed to buy 1.7 million courses of molnupiravir for $1.2 billion and is now exercising options to buy 1.4 million more.”

WHO warns of shortage of 1 to 2 billion COVID-19 vaccine syringes: “There could be a shortage of one to two billion syringes needed to administer COVID-19 vaccinations in 2022 which could also impact routine immunisations and undermine needle safety, the World Health Organization warned on Tuesday…”

Moderna took NIH money and help for its covid vaccine. Now it wants to leave government scientists off a lucrative patent.: “Moderna is disputing some claims by the National Institutes of Health that it was behind the invention of the company’s mRNA coronavirus vaccine, raising the stakes in the debate over the government’s ability to exert influence over the availability and price of the vaccine in the future.
At the core of the dispute is the contribution of NIH-funded scientists who worked closely with Moderna at the dawn of the pandemic to develop the groundbreaking vaccine.
The dispute was revealed in patent applications filed by Moderna that were reviewed by researchers for the consumer advocacy group Public Citizen.
Some of Moderna’s applications excluded government-funded scientists.”

Surgeon general releases guide to combating COVID-19 vaccine misinformation: See the article for the illustrated “toolkit” to be used to combat misinformation.

Association of Self-reported COVID-19 Infection and SARS-CoV-2 Serology Test Results With Persistent Physical Symptoms Among French Adults During the COVID-19 Pandemic: “In this cross-sectional analysis of 26 823 adults from the population-based French CONSTANCES cohort during the COVID-19 pandemic, self-reported COVID-19 infection was associated with most persistent physical symptoms, whereas laboratory-confirmed COVID-19 infection was associated only with anosmia. Those associations were independent from self-rated health or depressive symptoms.
Findings suggest that persistent physical symptoms after COVID-19 infection should not be automatically ascribed to SARS-CoV-2; a complete medical evaluation may be needed to prevent erroneously attributing symptoms to the virus.”

Express Scripts Creates Industry-First Solution to Provide Coverage for At-Home COVID-19 Test Kits : “Beginning January 1, 2022, members of plans who enroll in this Express Scripts solution can visit a participating in-network pharmacy, choose an applicable COVID-19 OTC test kit, and show their Express Scripts member ID card at checkout to process the kit through their pharmacy benefit. Plans have the flexibility to set the member copay for the tests, either at a discounted rate or $0 copay.”

About the public’s health

Accelerometer-derived sleep onset timing and cardiovascular disease incidence: a UK Biobank cohort study : ”Growing evidence suggests that poor sleep health is associated with cardiovascular risk. However, research in this area often relies upon recollection dependent questionnaires or diaries. Accelerometers provide an alternative tool for measuring sleep parameters objectively…
An age- and sex-controlled base analysis found that sleep onset time of 10:00 p.m.–10:59 p.m. was associated with the lowest CVD incidence…
Importantly, sensitivity analyses revealed this association with increased CVD risk was stronger in females…”

Type of fat, not how much, linked to stroke risk, study finds: “The study found that eating more animal fat was linked to a higher risk of stroke, while getting more fat from vegetable sources was linked to a lower risk…
The results come from 27 years of data from more than 117,000 health care professionals. The data were pulled from two of the largest and longest-running nutritional studies in the U.S. — the Nurses’ Health Study and the Health Professionals Follow-Up Study.”

Adults Who Report Fair or Poor Health Status by Race/Ethnicity: The report is based on 2020 data and should be cautiously interpreted; self-reported data does not often correlate well with objective data. The poorest health reported is Puerto Rico, followed by West Virginia. The best reported health is in D.C., followed by Massachusetts.

About healthcare devices

FDA clears AFib notification on Apple Watch: “If the irregular rhythm consistent with AFib is identified and confirmed, IRNF 2.0 Watch app will notify the user and transfer the AFib notification to the iPhone Health App through Apple’s HealthKit sync. It will encourage the user to seek medical care. The app will display a history of all prior AFib notifications and allow the user to view a list of times for the irregular rhythms contributing to the notification.”

FDA Designates ReWalk’s ReBoot Soft Exo-Suit a Breakthrough Device: “ReBoot is a lightweight, battery-powered orthotic exo-suit intended to assist ambulatory functions in people with reduced ankle function related to neurological injuries, such as stroke. It works in conjunction with the muscles of the affected leg to assist with maintaining safe foot positioning and with pushing off the ground, which means it may improve users’ gait.”

GE Plans to Form Three Public Companies Focused on Growth Sectors of Aviation, Healthcare, and Energy: “GE Aviation, GE Healthcare, and the combined GE Renewable Energy, GE Power, and GE Digital businesses [are] to become three industry-leading, global, investment-grade public companies…”
GE Healthcare will be a tax-free spinoff, “creating a pure-play company at the center of precision health in early 2023, in which GE expects to retain a stake of 19.9 percent…”

About pharma

Sun Pharma Agrees to $85 Million in Settlements Over Price-Fixing Allegations: “Two U.S. subsidiaries of Indian generics company Sun Pharmaceutical Industries have reached settlements totaling $85 million with plaintiffs in the companies’ drug-pricing antitrust litigation, said Sun in a statement…
From 2013 to 2015, according to the U.S. Department of Justice, Taro Pharmaceuticals USA, Sandoz and Apotex are alleged to have conspired to set prices on a number of popular unnamed generic drugs. The companies are alleged to have paid each other — and other unnamed companies — to manipulate price, supply and customer allocations between 2013 and 2015.”

AstraZeneca to set up division for vaccines and antibody therapies: The headline is the story.

About hospitals and health systems

Record Number of Hospitals Receive an ‘A,’ ‘B,’ ‘C,’ ‘D,’ or ‘F’ on the Leapfrog Hospital Safety Grade: Published today on the Leapfrog website. Highlights:

  • “Thirty-two percent of hospitals received an "A," 26% received a "B," 35% received a "C," 7% received a "D," and less than 1% received an "F.”

  • The five states with the highest percentages of "A" hospitals are Virginia, North Carolina, Idaho, Massachusetts, and Colorado.

  • There were no "A" hospitals in Delaware, Washington, DC, and North Dakota.”

About medical groups

Justice Department probing Oak Street Health for potential false claims violations: “The Justice Department is investigating Oak Street Health, a Chicago-based network of primary care centers for Medicare beneficiaries, over potential False Claims Act violations, according to a filing the company submitted to the Securities and Exchange Commission.  
The Justice Department requested a civil investigative demand from the company on Nov. 1. It is requesting documents and information related to Oak Street Health's relationships with third-party marketing agents and its service offering free rides to Medicare beneficiaries.”
Offering “free” services to Medicare recipients can lead to charges of illegal inducements. Medicare Advantage companies have received federal permission to offer many non-traditional services; however, Oak Street is a provider and may not fall under those permissions.

Today's News and Commentary

About Covid-19

White House tells businesses to proceed with vaccine mandate despite court-ordered pause: “The White House on Monday said businesses should move forward with President Joe Biden’s vaccine and testing requirements for private businesses, despite a federal appeals court ordering a temporary halt to the rules.”

How protein-based COVID vaccines could change the pandemic: “Unlike the relatively new technologies that the mRNA and viral-vector COVID-19 shots are based on, protein vaccines have been used for decades to protect people from hepatitis, shingles and other viral infections. To elicit a protective immune response, these shots deliver proteins, along with immunity-stimulating adjuvants, directly to a person’s cells, rather than a fragment of genetic code that the cells must read to synthesize the proteins themselves.
Although protein vaccines are not yet in widespread use for COVID-19, late-stage clinical-trial data so far look promising, demonstrating strong protection with fewer side effects than other COVID-19 shots typically cause.”

Rite Aid to make vaccine sign-up site accessible after DOJ intervenes: “The DOJ said in a release Monday that the site’s calendar didn’t show screen reader users any available appointment times, and those who use the tab key instead of a mouse couldn’t complete the required consent form.
The agreement also alleged the site included some text and links with low color contrast, introducing difficulties for individuals with low vision.”

Qiagen Gets CE Mark for COVID-19, Influenza A and B, RSV Test: “Qiagen has received the CE mark for its QIAstat-Dx Respiratory 4 Plex Flu A-B/RSV/SARS-CoV-2 test, which runs on the company’s QIAstat-Dx system.
The test is intended to quickly identify whether patients have common seasonal respiratory infections or COVID-19…”

OVID-19 Misinformation is Ubiquitous: 78% of the Public Believes or is Unsure About At Least One False Statement, and Nearly a Third Believe At Least Four of Eight False Statements Tested: A fascinating article about misconceptions. One very interesting finding is beliefs by news source:
”People’s trusted news sources are correlated with their belief in COVID-19 misinformation. At least a third of those who trust information from CNN, MSNBC, network news, NPR, and local television news do not believe any of the eight false statements, while small shares (between 11% and 16%) believe or are unsure about at least four of the eight false statements.
Larger shares of those who trust COVID-19 information from leading conservative news sources believe misinformation, with nearly 4 in 10 of those who trust Fox News (36%) and One America News (37%), and nearly half (46%) of those who trust Newsmax, saying they believe or are unsure about at least half of the eight false statements.”

Pfizer-BioNTech expected to seek authorization for coronavirus booster for people 18 and older: “The request, which may be filed as soon as this week, is likely to win the backing of the Food and Drug Administration, said the individuals, who spoke on the condition of anonymity because they were not authorized to discuss the issue. That would essentially fulfill the Biden administration’s booster-for-all-adults goal, announced last August amid concerns about waning vaccine protection.”

About pharma

Purdue Agrees Not To Finalize Ch. 11 Plan Until Appeals Done: “A New York bankruptcy judge said Tuesday that a stay of the implementation of Purdue Pharma's Chapter 11 plan pending appeals was unnecessary after Purdue agreed not to take the plan's final steps until after the first round of appeals are decided.”

Drugmakers get mixed bag in lawsuit rulings over 340B contract pharmacy moves: “A federal judge found drug companies cannot unilaterally restrict sales of products discounted under the 340B program to contract pharmacies.
But a separate ruling found that manufacturers don’t have to provide discounts.
The opinions, released late Friday, are the latest in a legal fight between six drugmakers and the Biden administration over whether they must offer discounted products to contract pharmacies. Federal judges issued separate rulings in lawsuits filed by Novo Nordisk, Sanofi, Novartis and United Therapeutics.
The lawsuits were filed in response to Health Resources and Services Administration’s (HRSA's) decision in May to warn the six drugmakers—Eli Lilly, Sanofi, United Therapeutics, Novartis, AstraZeneca and Novo Nordisk—to walk back the restrictions imposed in summer 2020.”

Merck Announces Receipt of Antitrust Clearance in Germany and Austria Relating to Tender Offer to Acquire Acceleron Pharma Inc.: The SEC still needs to give final clearance.

Oklahoma Court Overturns $465M Opioid Ruling Against J&J: “The Oklahoma Supreme Court on Tuesday overturned a $465 million opioid ruling against drugmaker Johnson & Johnson, finding that a lower court wrongly interpreted the state's public nuisance law.
The court ruled in a 5-1 decision that the district court in 2019 was wrong to find that New Jersey-based J&J violated the state’s public nuisance statute. It also rejected the state’s appeal to increase the damage award.”

Unsealed Emails Show How J&J Shaped Report on Talc's Links to Cancer: “Unsealed emails reveal the role baby-powder maker Johnson & Johnson played in a report that an industry group submitted to U.S. regulators deciding whether to keep warnings off talc-based products linked to cancer.
The emails -- unsealed in the state of Mississippi’s lawsuit against J&J over its refusal to add a safety warning -- show J&J and its talc supplier chose the scientists hired by their trade association, the Personal Care Products Council, to write the 2009 report assessing talc-based powders’ health risks. They also show the researchers changed the final version of their report at the companies’ behest.
The U.S. Food and Drug Administration said it relied in part on the report in its decision to forgo a warning for the product.”

About hospitals and health systems

10 Years of Hospital Readmissions Penalties: “Over the lifetime of the program, 2,920 hospitals have been penalized at least once. That’s 93% of the 3,139 general acute hospitals subject to HRRP [Hospital Readmission Reduction Program] evaluation, and 55% of all hospitals. Moreover, 1,288 have been punished in all 10 years. Only 219 eligible hospitals have avoided any payment reductions since the program’s start in 2013, though more than 2,000 hospitals are automatically exempt from penalties because they have specialized functions: those that focus on children, psychiatric patients, veterans, rehabilitation and long-term care or those that serve as the only hospital in an area.”

Tenet and USPI to Acquire SurgCenter Development and Establish Long-Term Development Partnership:
“Tenet Healthcare Corporation (NYSE: THC), and its subsidiary United Surgical Partners International (USPI), today announced that they have entered into a definitive agreement with the principals of SurgCenter Development (SCD) to acquire SCD. Under the terms of the agreement, Tenet/USPI will acquire SCD’s ownership interests in 92 ambulatory surgery centers (ASCs) and other related ambulatory support services (collectively, the Portfolio).
USPI and SCD’s principals will also enter into a five-year partnership and development agreement designed to provide seamless continuity and support for SCD’s facilities and physician partners over the coming years. Going forward, USPI also has the exclusive option to partner with SCD on de novo development projects over the life of the agreement…
Tenet/USPI will acquire SCD’s ownership interests in 92 ASCs and related ambulatory support services for approximately $1.2 billion.”

25 attorneys general urge court to block New Jersey hospital merger: This action highlights the national attention hospital mergers are receiving.
“California Attorney General Rob Bonta and Pennsylvania Attorney General Josh Shapiro are leading the multistate coalition that is urging an appeals court to keep intact the Aug. 4 decision by the U.S. District Court for the District of New Jersey to grant a preliminary injunction blocking the merger. 
In its decision, the district court said the merger would result in anticompetitive effects like higher prices and lower-quality care. Less than a month after the court's decision, Hackensack Meridian and Englewood Health filed an appeal.
The coalition argues the appeals court should block the merger because ‘states have seen a wave of hospital consolidation, resulting in large healthcare systems with substantial market power and the ability to wield it to the detriment of insurers and patients,’ according to a news release from Mr. Bonta's office.”
In a related article on the same topic: Hospital M&A: 18 recent deals

About healthcare IT

Researchers uncover software flaws leaving medical devices vulnerable to hackers: “Researchers say they have found more than a dozen vulnerabilities in software used in medical devices and machinery used in other industries that, if exploited by a hacker, could cause critical equipment such as patient monitors to crash. 
The research, shared exclusively with CNN, points to the challenges that hospitals and other facilities have had in keeping sensitive software updated as the resource-absorbing coronavirus pandemic continues. It's also an example of how federal agencies are working more closely with researchers to investigate cybersecurity flaws that could affect patient safety.
Nearly 4,000 devices made by a range of vendors in the health care, government and retail sectors are running the vulnerable software, according to cybersecurity firms Forescout Technologies and Medigate, which discovered the issue.”

Today's News and Commentary

About Covid-19

Appeals court stays vaccine mandate on larger businesses“The 5th U.S. Circuit Court of Appeals granted an emergency stay of the requirement by the federal Occupational Safety and Health Administration that those workers be vaccinated by Jan. 4 or face mask requirements and weekly tests.
Louisiana Attorney General Jeff Landry said the action stops President Joe Biden ‘from moving forward with his unlawful overreach.’
‘The president will not impose medical procedures on the American people without the checks and balances afforded by the constitution,’ said a statement from Landry, a Republican. 
The U.S. Labor Department’s top legal adviser, Solicitor of Labor Seema Nanda, said the department is ‘confident in its legal authority to issue the emergency temporary standard on vaccination and testing.’”

SARS-CoV-2 vaccine protection and deaths among US veterans during 2021: Although breakthrough infection increased risk of death, vaccination remained protective against death in persons who became infected during the Delta surge. From July to October 2021, VE-D for age 65 years was 73.0% for Janssen, 81.5% for Moderna, and 84.3% for Pfizer-BioNTech; VE-D for age ≥65 years was 52.2% for Janssen, 75.5% for Moderna, and 70.1% for Pfizer-BioNTech. Findings support continued efforts to increase vaccination, booster campaigns, and multiple, additional layers of protection against infection.”

NIH scientists identify mechanism that may influence infectivity of SARS-CoV-2 variants: “The outer surface of SARS-CoV-2 is decorated with spike proteins, which the virus uses to attach to and enter cells. Before this can happen, though, the spike protein must be activated by a series of cuts, or cleavages, by host proteins, starting with the furin enzyme. In the alpha and delta variants, mutations to the spike protein appear to enhance furin cleavage, which is thought to make the virus more effective at entering cells.”

Israeli plan for COVID vaccine tablet gets $4.3m from Bill Gates-backed fund: “MigVax is aiming not only to produce a tablet vaccine, but also to make it particularly sturdy against new variants as well as adaptable to future viruses. It expects to achieve these aims using its subunit vaccine, which contains purified pieces of the virus that were selected for their ability to stimulate immune cells.”

The United States reopens to vaccinated international travelers:  The previously reported travel rules have been officially implemented. Airlines are responsible for gathering and verifying information from their customers. Each state’s laws (especially masking) still apply. The article is a good reminder of the terms.

These two article are excellent explanations of the topics in their headlines: 
Pediatric COVID-19 Vaccines: What Parents, Practitioners, and Policy Makers Need to Know

Understanding Breakthrough Infections Following mRNA SARS-CoV-2 Vaccination

Regeneron COVID-19 antibody drug reduces infection risk 82% in clinical trial: Regeneron said Nov. 8 that its COVID-19 antibody cocktail reduced the risk of contracting COVID-19 by 81.6 percent for eight months after administration in a phase 3 clinical trial. 
During the eight-month follow-up period, Regeneron said there were no hospitalizations from COVID-19 infection among the people receiving the antibody cocktail, called REGEN-COV, and six in the placebo group.”

30 pharmacies ranked by customer satisfaction: FYI: Good Neighbor Pharmacy is the highest-ranked [brick and mortar and all-category] pharmacy in the U.S. in terms of customer satisfaction, according to consumer insight firm J.D. Power's annual pharmacy satisfaction survey.” Check the article or survey for the rest of the categories and rankings.

About hospitals and health systems

Michigan systems to disband 5,400-physician network: “Five Michigan health systems are ceasing operation of Affirmant Health Partners, their clinically integrated network, at the end of this year. 
The following five Michigan organizations make up Affirmant Health Partners: Saginaw-based Covenant HealthCare; Detroit-based Henry Ford Health System; St. Joseph-based Spectrum Health Lakeland; Lansing-based Sparrow Health System; and Kalamazoo-based Bronson Healthcare Group.
The decision by Affirmant Health Partners' board to shutter operation of the 5,400-physician network was attributed to several factors, including changes in strategy among the five participating systems and reductions in Medicare participation.”

About pharma

Moderna finally cracks into gene editing with Metagenomi pact thanks to 'irresistible' dataModerna “has signed a research partnership with CRISPR gene editing company Metagenomi…
[T]he partnership will involve in vivo treatment options for serious genetic diseases. Metagenomi will offer up access to its gene editing tools while Moderna will bring the expertise in mRNA and lipid nanoparticle delivery technologies.”

Pharmaceutical industry likely to shatter its lobbying record as it works to shape Democrats’ spending bill:  “The influence campaign at times worked through groups whose funding sources are hidden. At least 20 different advertisements were run on television and online across the country. The advertisements were augmented by a campaign by PhRMA, which spent nearly $23 million on lobbying through the first nine months of 2021, according to data compiled by OpenSecrets, which tracks corporate spending and political influence. That puts PhRMA on track this year to beat its own spending recording of $29.3 million in 2019.”

About healthcare IT

On-Demand Telehealth Is Booming Even as a Fierce Competitor Remains: the Doctor’s Office : The article is a good summary of opinions of those who use telehealth.For example: “72% of U.S. adults who have used telehealth said they’ve accessed virtual care through their regular provider or health plan, while another 17% have gotten care through a direct-to-consumer platform and 11% have used both types of services.
53% of U.S. adults said they’d rather use in-person health care than telehealth moving forward, but that share fell to 45% among those who have used telehealth in the past.”
About 90% of those using telehealth found it to be friendly, easy and affordable.

 What Healthcare Consumers Want and Need from Life Sciences Manufacturers: While the title sounds like a product marketing piece, it is really about how members of different generations seek information about healthcare and how much they trust the sources.
While there are obviously differences, in the category: “Which channels are the most effective in reaching consumers seeking healthcare information?”, all groups rate the physician’s office as the number one source.

 

 

 

 

 

 

 

 

 

 

 

Today's News and Commentary

About Covid-19

Experimental Pfizer pill prevents Covid hospitalizations and deaths“The Pfizer medicine, known by the code name PF-07321332 or simply ’332, reduced hospitalization by 89% compared to placebo when given with the HIV drug ritonavir within three days of symptom onset. The medicine also reduced the chance that patients would die. There were 7 deaths out of 385 patients in the placebo group, and none in the 389-patient group that received the medicines. Pfizer plans to market ‘332 under the brand name Paxlovid.”

Pandemic marked by premature deaths, lost years of life“More than 28 million extra years of life were lost among 31 high- and upper-middle–income countries, and 33 nations saw declines in life expectancy, amid the COVID-19 pandemic in 2020, concludes a study yesterday in BMJ.”

Study into gene that affects Covid severity should be treated with caution“In the second wave of the pandemic those with Pakistani backgrounds were more than twice as likely to die from Covid-19 than those from white European backgrounds. For those of Bangladeshi heritage the risk was three- to four-fold…
Now, it seems, part of the explanation could be genetic. A gene has been found that alters the way that cells in the lining of the lungs respond to the Covid-19 infection…
The University of Oxford scientists behind the study estimate that the high-risk gene is carried by about 60% of those with south Asian heritage, compared with 15% of those with white European backgrounds and just 2% of those with black African or Caribbean heritage.”

Moderna cuts forecast for COVID-19 vaccine sales: “Moderna downgraded the 2021 sales expectations for its COVID-19 vaccine Spikevax to between $15 billion and $18 billion, from $20 billion projected in August, saying it will have fewer doses for delivery this year. The disclosure, made during its third-quarter earnings call on Thursday, sent shares tumbling as much as 17%….
Moderna explained that its output has been affected by ‘longer delivery lead times for international shipments and exports that may shift deliveries to early 2022, temporary impact from expansion of fill/finish capacity and ramp-up of product release to market.’
By contrast, Pfizer earlier this week raised the sales projection for its BioNTech-partnered coronavirus vaccine Comirnaty for the third time this year, saying it now expects sales of $36 billion from the shot, reflecting the delivery of 2.3 billion doses.”

Antibody Titers Before and After a Third Dose of the SARS-CoV-2 BNT162b2 [Pfizer] Vaccine in Adults Aged ≥60 Years: “This study found that a third BNT162b2 dose in adults aged 60 years and older was associated with significantly increased IgG titers after 10 to 19 days, with no major adverse events.”

LumiraDx’s COVID-19 Antigen Test Expands Indication to Asymptomatic People“The FDA has granted an expanded Emergency Use Authorization for LumiraDx’s COVID-19 antigen test to include testing of asymptomatic people.
In asymptomatic individuals, the 12-minute test was 82.1 percent agreement on positive results and 100 percent agreement on negative results, when compared with results from a laboratory polymerase chain-reaction test, according to the UK-based company.”

More than 10K patients contracted COVID after visiting a hospital for other care“More than 10,000 patients were diagnosed with COVID in a U.S. hospital last year after they were admitted for something else, according to federal and state records analyzed exclusively for KHN. The number is certainly an undercount, since it includes mostly patients 65 and older, plus California and Florida patients of all ages.”

U.S. cancels multimillion-dollar deal with coronavirus vaccine maker whose plant ruined Johnson & Johnson doses: “The federal government has canceled a deal worth $628 million with Emergent BioSolutions, the Maryland-based vaccine manufacturer that was a vanguard of the Trump administration’s program to rapidly produce vaccines to counter the coronavirus pandemic.

The company disclosed the development on Thursday in a conference call discussing its latest financial results. The cancellation comes after Emergent’s manufacturing facilities in Baltimore were found to have produced millions of contaminated vaccine doses this spring, prompting a months-long shutdown.”

DeSantis says OSHA rules on vaccines, masks are federal overreach. Florida’s suing“Gov. Ron DeSantis announced Thursday he would join a lawsuit with Georgia, Alabama and private plaintiffs seeking to nullify a rule by President Joe Biden’s administration mandating coronavirus vaccines or testing in large workplaces. At a news conference in Tallahassee, DeSantis said the rule was an example of federal overreach. The federal government does not have the power to hand down health mandates, DeSantis argued, nor does it have the power to enforce its rule with fines as high as $13,653 per violation. He also argued that a rule that has been coming for close to two months and which requires workers to be vaccinated by Jan. 4 can hardly be a response to an ‘emergency.’”

A doctor spread COVID misinformation and renewed her license with a mouse click: “For much of the pandemic, Dr. Lee Merritt has appeared on talk shows and in lecture halls to spread false information about COVID-19.
Among her claims: that the SARS-CoV2 virus is a genetically engineered bioweapon (the U.S. intelligence community says it's not). And that vaccination dramatically increases the risk of death from COVID (data show an enormous drop in risk for those who take the vaccine). The entire pandemic, she says in public lectures, is a vast global conspiracy to exert social control.
And yet, in October, she was able to renew her medical license in the state of Nebraska. Documents obtained through a public records request by NPR showed it took just a few clicks: 12 yes-or-no questions answered online allowed her to extend her license for another year. Critics say that Merritt's renewal is another example of how the nation's state medical boards are failing to protect the public from a small minority of doctors spreading COVID falsehoods.”
State medical boards said they would not allow renewals for such physicians, however, enforcement is obviously lax. Perhaps something akin to a “no fly list” is needed to flag such people.

About health insurance

 Healthcare Affordability State Policy Scorecard: From Altarum. Massachusetts and R.I. are at the top, while Georgia and Texas are at the bottom. 

Arkansas Man Charged in $100 Million COVID-19 Health Care Fraud Scheme: According to court documents, Billy Joe Taylor, 42, of Lavaca, engaged in a scheme between February 2017 and May 2021 in connection with diagnostic laboratory testing, including urine drug testing and tests for respiratory illnesses during the COVID-19 pandemic, that were medically unnecessary, not ordered by medical providers, and/or not provided as represented. According to the indictment, Taylor controlled and directed multiple diagnostic laboratories, and used those labs to submit more than $100 million in false and fraudulent claims to Medicare. The indictment alleges that Taylor obtained medical information and private personal information for Medicare beneficiaries, and then misused that confidential information to repeatedly submit claims to Medicare for diagnostic tests that were not ordered by medical providers and were not actually performed by the laboratories.”

Health Insurance Trends-November 2021A survey from eHealth.
Some highlights:
“83% of Medicare beneficiary survey respondents want the federal government to take direct action to lower the cost of prescription drugs by negotiating with pharmaceutical companies. This is true across
political lines, including strong majorities of Democrats (93%), Republicans (73%), and Independents (84%).

92% of Medicare beneficiaries would like to see dental, vision, and • hearing benefits added to traditional Medicare coverage, but only 50% feel the same if it would add to their costs.

When asked if they felt the health insurance options available to them addressed the specific medical needs of their racial or ethnic community, Hispanic respondents were least likely to say yes (41%), followed by Asian (45%), and Black (46%) respondents. By contrast, 58% of white respondents answered yes.

With an estimated 10,000 new Medicare beneficiaries every day, the number one place they go to learn about their Medicare coverage options is online.

69% of them want the freedom to look beyond government-run online marketplaces to shop for, compare, and enroll in coverage. 

When it comes to health care innovation and technology, more than half (52%) of general population respondents say private enterprise does a better job than government. Only 18% say the government does a better job.”

About healthcare IT

 How Likely Your State’s Businesses are to Recover from Cyberattacks: From a Verizon study. See the article for methodology and rankings. The best is Vermont and the worst is Delaware.

Alphabet launches AI drug discovery venture built on DeepMind's protein-folding expertise: “Google’s parent company Alphabet is diving into the drug discovery game with an artificial intelligence company built on the protein-folding simulation successes achieved at DeepMind.
The new Isomorphic Laboratories aims to deliver an ‘AI-first approach’ for tackling biopharma research, with the goal of serving as a commercial partner to drugmakers and figuring out how medicines will react within the body.”

Federal agencies rush to patch hundreds of cyber vulnerabilities within 6 months: “As hackers launched increasingly damaging threats against critical infrastructures such as hospitals, the Cybersecurity and Infrastructure Security Agency is requiring all federal agencies to patch cyber vulnerabilities within six months, according to a Nov. 3 directive
Under the binding operational directive, federal agencies must establish policies to remediate approximately 300 known exploited vulnerabilities known to CISA within 60 days. Federal agencies have two weeks to patch vulnerabilities discovered in 2021 and six months to patch vulnerabilities discovered prior to 2021.”

About hospitals and health systems

2021 State of Healthcare Performance Improvement: COVID Creates a Challenging EnvironmentA survey by KaufmanHall. 
Highlights: 
“100% of survey respondents face issues with clinical staff, including burnout, difficulty filling vacancies, wage inflation, and high turnover rates. 
99% have experienced challenges in supply procurement, including shortages of key items and significant price increases. 
92% are having difficulties attracting and retaining support staff, and almost 90% have increased base salaries . 
75% have experienced adverse revenue cycle impacts during the pandemic, including a higher percentage of Medicaid patients and increased rates of denial . 
54% identify a “pain point” at an investment (or subsidy) per physician of $250,000 or less. The average investment per physician at the end of Q2 2021 was $232,583 . 
23% say that the ratio of administrative staff working remotely is likely to return to pre-pandemic levels. 66% said the ratio will remain at levels reached during the pandemic, and 11% said the percentage of staff working remotely will continue to increase. 
22% have seen pediatric services return to pre-pandemic levels, while 16% say pediatric volumes remain below 75% of pre-pandemic levels. Cardiology and cardiovascular services have seen the most significant rebound, but even here, just 44% of respondents have seen a return to pre-pandemic levels.”

About diagnostics

Test determines antibiotic resistance in less than 90 minutes: “A technique that measures the metabolic activity of bacteria with an electric probe can identify antibiotic resistance in less than 90 minutes, a dramatic improvement from the one to two days required by current techniques.
This discovery means that doctors could quickly know which antibiotics will or won't work for a patient's life-threatening infection, a quandary that doctors face on a daily basis in hospitals around the world. A Washington State University research team reports on their work in the journal, Biosensors and Bioelectronics.”

 

 

Today's News and Commentary

About Covid-19

Cue the lawsuits: Biden's vaccine mandates are here: The official recommendations are now out. The article provides a good summary of what will be officially published in The Federal Register tomorrow.
Among the highlights:
The Biden administration is implementing a true vaccine mandate for 17 million health-care workers. The emergency regulation requires vaccines for staff of the roughly 76,000 health facilities participating in Medicare and Medicaid, such as nursing homes, hospitals and home health agencies. Unlike other mandates, staff won’t be allowed to test regularly in lieu of getting the shot, though it does include religious and medical exemptions…”
CMS is making the immunization a Condition of Participation for Medicare, meaning that non-compliant hospitals can lose their Medicare provider status.
Companies with 100 or more employees must now mandate coronavirus vaccine shots or weekly testing. 
The Occupational Safety and Health Administration is relying on little-used emergency powers to issue the new rules expected to cover 84 million workers. 
Under the regulations:

  • The unvaccinated will be required to wear masks.

  • Employers must provide paid time off for their staff to get a shot.

  • Companies can make their employees foot the bill for their own tests.”

EMA Scraps Review of Eli Lilly’s COVID-19 Antibody Therapy: “The European Medicines Agency (EMA) has stopped its rolling review of Eli Lilly’s COVID-19 antibody cocktail after the drugmaker withdrew its request because of the lack of demand among EU member states.”
Contrast that action with the US where the federal government announced it will purchase “a further 614,000 doses of Eli Lilly’s COVID-19 therapy, bamlanivimab and etesevimab, for $1.29 billion.”

Britain authorizes Merck’s molnupiravir, the world’s first approval of oral covid-19 treatment pill: “Regulators in Britain granted approval to the experimental drug molnupiravir from U.S. pharmaceutical giant Merck on Thursday, marking the first authorization from a public health body for an oral antiviral treatment for covid-19 in adults.”

Visualizing in deceased COVID-19 patients how SARS-CoV-2 attacks the respiratory and olfactory mucosae but spares the olfactory bulb: Covid-19 appears to inflict the peripheral mucosa causing derangements in smell. “Thus, SARS-CoV-2 does not appear to be a neurotropic virus.” What the finding means is that, since permanent central nerve damage is not occurring, prospects for recovery of function are good.

About the public’s health

Life expectancy fell sharply in the U.S. last year among high-income countries: “The United States had the second-steepest decline in life expectancy among high-income countries last year during the pandemic, according to a study of death data spanning several continents
The only country studied that saw a starker overall trend was Russia.
U.S. men saw life expectancy fall by nearly 2.3 years, from about 76.7 to 74.4. Women lost more than 1.6 years of life expectancy, from about 81.8 to 80.2…
One surprise: The drop in life expectancy in the U.S. was driven by the deaths of young people…”

Panel: All US adults under 60 should get hepatitis B shots: “The Advisory Committee on Immunization Practices voted unanimously to approve the recommendation Wednesday. The CDC’s director, Dr. Rochelle Walensky, must sign off on it before it becomes public policy, but it’s not clear when she will decide.”

The effects of the national HPV vaccination programme in England, UK, on cervical cancer and grade 3 cervical intraepithelial neoplasia incidence: a register-based observational study: “We observed a substantial reduction in cervical cancer and incidence of CIN3 in young women after the introduction of the HPV immunisation programme in England, especially in individuals who were offered the vaccine at age 12–13 years. The HPV immunisation programme has successfully almost eliminated cervical cancer in women born since Sept 1, 1995.”
For those vaccinated at age 12-13 the risk reduction was 97%.

About pharma

Novartis to sell Roche stake for $20.7 billion: “Novartis said Thursday that it agreed to sell its stake in Roche for $20.7 billion, with the proceeds to be used ‘in line with capital allocation priorities to enhance strong returns to shareholders.’ Novartis built up the stake between 2001 and 2003, and currently holds 53.3 million bearer shares of Roche's stock, representing approximately 33% of aggregate outstanding bearer shares.
’After more than 20 years as a shareholder of Roche, we concluded that now is the right time to monetise our investment,’ remarked Novartis CEO Vas Narasimhan.”

About health insurance

45% of Insured Americans Considering Health Insurance Changes During Open Enrollment: “Most commonly, those looking to change their health insurance are doing so in response to the COVID-19 pandemic (35%) or their transforming health needs (33%).
Additionally, 27% of consumers are considering changing their health insurance coverage for cost-related reasons. For 18% of this group, the driving force is that out-of-pocket costs were too high last year. Another 9% of people feel they pay for more insurance than what they use, so they're seeking to cut back on expenses.”
Next is seeing how many actually switched, as contemplation of changing insurance is not highly correlated with actual changing.

Centene selling off majority stake in U.S. Medical Management: “Centene will sell off its majority stake in home health company U.S. Medical Management, the insurer announced Wednesday.
Centene will maintain a minority stake in USMM, according to the announcement, and will sell the rest of its stake to Rubicon Partners; Valtruis, a WCAS company; Oak HC/FT; and HLM Venture Partners. 
USMM operates a family of companies that provide home health services, and in 2015 launched an accountable care organization. It owns assets that assist with home-based primary care and house call programs, according to the announcement.”
A noteworthy development as other insurers are increasingly vertically integrating. As an example:

CVS Looks to Add Doctors to Its Payroll: “On Wednesday, CVS Chief Executive Karen Lynch said the company is working with “speed and urgency” to create physician-staffed primary-care practices, which she said will be a priority for CVS as it considers potential acquisitions in the coming year.
’Primary care isn’t a big medical cost but it wields a lot of influence,’ Ms. Lynch said in an interview, referring to the role physicians can play in lowering insurers’ costs.”

Cigna beats the Street with $1.6B in Q3 profit: “Cigna wrapped up third-quarter earnings for major national payers Thursday morning, where it reported $1.6 billion in profit for the quarter.
The results surpassed Wall Street expectations, according to Zacks Investment Research. Cigna also brought in $44.3 billion in revenue in the third quarter, according to the earnings report, which also beat analysts' projections.”

Humana cuts 2021 outlook after higher COVID-19 expenses but still plans robust Medicare Advantage growth for 2022: “Humana expects its individual Medicare Advantage membership to grow by 8% in 2022 as part of a more conservative financial outlook. 
The insurer gave hints to its outlook for next year as part of its earnings report released Wednesday that saw Humana post a $1.5 billion profit in the third quarter but cut its financial outlook for 2021 due in part to higher-than-expected COVID-19 costs.
The insurer’s third-quarter earnings report, though, released Wednesday, pointed to strong growth in its Medicare Advantage offerings and lower-than-expected healthcare use among MA beneficiaries.”

CY 2022 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Final Rule (CMS-1753FC): The announcement has specifics about price transparency requirements (previously reported), OPPS and ASC payment rates, changes to the inpatient-only list, and much more.

Calendar Year (CY) 2022 Medicare Physician Fee Schedule Final Rule: Many more details about changes, including telehealth payment and the previously reported new conversion factor:
”With the budget neutrality adjustment to account for changes in RVUs (required by law), and expiration of the 3.75 percent temporary CY 2021 payment increase provided by the Consolidated Appropriations Act, 2021 (CAA), the CY 2022 PFS conversion factor is $33.59, a decrease of $1.30 from the CY 2021 PFS conversion factor of $34.89. The PFS conversion factor reflects the statutory update of zero percent and the adjustment necessary to account for changes in relative value units and expenditures that would result from our finalized policies.”

Today's News and Commentary

About health insurance

CMS Releases Final Rule for CY 2022 Medicare Physician Fee Schedule: “CMS has finalized the calendar year (CY) 2022 Medicare Physician Fee Schedule to promote greater telehealth utilization, boost reimbursement rates for vaccine administration, and improve health equity, among other initiatives, the federal agency said.
The final rule will implement ‘a series of standard technical proposals’ as part of CY 2022 rate-setting, CMS said. The conversion factor for next year will be $33.59, a decrease of $1.30 versus the CY 2021 conversion factor. Next year’s rate accounts for statutory changes to relative value units (RVUs) and the expiration of the 3.75 percent temporary CY 2021 payment increase Congress approved through pandemic-related legislation.
The CY 2022 conversion factor also reflects a statutory update of 0 percent and an adjustment necessary to account for changes in RVUs and expenses that would result from our finalized policies, according to the final rule.”

Hospital Price Transparency Penalties to Increase Under OPPS Rule: “Starting January 1, CMS will increase penalties for noncompliance with hospital price transparency requirements under the newly released Calendar Year (CY) 2022 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule.
The Final Rule sets the minimum civil monetary penalty of $300 per day for smaller hospitals with a bed count of 30 or fewer, and a penalty of $10 per bed per day for hospitals with a bed count greater than 30. However, the penalty is not to exceed a maximum daily dollar amount of $5,500.
Under the new approach, hospitals could be responsible for paying a maximum of over $2 million if they fail to comply with the requirements.”

Feds Nail Podiatrist For Alleged $11M Foot Bath Fraud Scheme : “A Mississippi podiatrist made Medicare and insurance companies foot the bill for more than $11. 3 million in prescriptions for pricey and unnecessary bath treatments, a federal indictment unsealed Tuesday claims. Foot doctor Carey ‘Craig’ Williams, 63, also allegedly took kickbacks for harvesting patients' toenails and wound swabs so a medical lab could perform, and seek reimbursement for, unnecessary bacterial and fungal screenings, prosecutors say. According to the indictment, Williams participated in the scheme for five years alongside two unidentified podiatrists and a Mississippi pharmaceutical sales representative…”
Can you spot the three puns in the story?

Bartko, Zankel, Bunzel & Miller Files Antitrust Lawsuit Against MultiPlan Co. & Major Health Insurers: “Bartko, Zankel, Bunzel & Miller filed a lawsuit on behalf of Verity Health Systems Liquidating Trust (‘Verity’) against MultiPlan and major health insurers for antitrust practices that violate California's Cartwright Act and Unfair Competition Law. MultiPlan admits its customers, healthcare insurance companies, paid Verity and other U.S. health care providers billions of dollars less annually than they otherwise would have for at least 10 years.
According to court documents, MultiPlan acted as an unlawful corporate hub as part of a "hub, spoke, and rim" agreement, together with most major insurance companies, to fix and artificially reduce the amounts of out-of-network reimbursement paid to hospitals. By setting lower, fixed prices for payments for healthcare provided by hospitals, MultiPlan worked with major insurance companies to exert their market dominance and cut reimbursements to hospitals by about $10 billion per year from 2012 through 2020.”

About Covid-19

Analysis of the Effectiveness of the Ad26.COV2.S Adenoviral Vector Vaccine for Preventing COVID-19: “This comparative effectiveness research study found that, through large-scale longitudinal retrospective curation of electronic health records from the multistate Mayo Clinic Health System, the Ad26.COV2.S vaccine [J&J] had an effectiveness of 74%.”

About pharma

Schumer announces deal to lower prescription drug prices: “The deal would allow negotiation after nine years for many drugs, known as small molecule drugs, and after 12 years for more complex drugs known as biologics, according to a summary obtained by The Hill.
If drug companies refuse to negotiate, they would face an excise tax as a punishment, a provision that has been controversial with some moderates.
Medicare could negotiate up to 10 drugs starting in 2025, and up to 20 drugs in 2028 and beyond, according to the summary.
Insulin copays would be capped at $35 per month.”

CVS Health beats on earnings, gets lift from Covid vaccines and prescription volumes: “The drugstore chain raised its forecast for the year, saying it expects adjusted earnings per share of $7.90 to $8.00, from $7.70 to $7.80.
The company administered 8.5 million Covid tests and 11.6 million shots during the three-month period.”

Company Q3 reports:
Novo Nordisk's sales, profit top expectations in Q3
Amgen boosts profit outlook despite Q3 sales hit by pricing pressure
Bausch Health's Q3 sales slip as earnings more than double

About the public’s health

'Impossible to enforce': Big Tobacco exploiting loopholes in European menthol ban: “Tobacco companies are finding loopholes in the Europe-wide menthol cigarette ban in order to keep selling products that can get new, younger smokers hooked on tobacco.
Japan Tobacco International (JTI) – which owns Sterling, Benson & Hedges and Sovereign – has been able to work around a ban imposed in 2020 that was intended to prevent young people from taking up smoking cigarettes. Competitors have called for governments to investigate the company’s new ‘menthol reimagined’ products.”

About healthcare professionals

Trends in Outpatient Care for Medicare Beneficiaries and Implications for Primary Care, 2000 to 2019: “Outpatient care for Medicare beneficiaries has shifted toward more specialist care received from more physicians without increased primary care contact. This represents a substantial expansion of the coordination burden faced by PCPs.”

Today's News and Commentary

About Covid-19

CDC signs off on children’s coronavirus vaccine, allowing providers to begin immunizing kids ages 5 to 11 immediately

ADDENDUM: Yesterday, news media reported that global Covid-19 deaths surpassed 5 million. In reviewing the list of countries, China’s absence is notable.

Novavax Files for COVID-19 Vaccine Authorization in Canada, EU: “Novavax has completed regulatory submissions with Health Canada and the European Medicines Agency for authorization of its COVID-19 vaccine, NVX-CoV2373, and said it will seek an FDA Emergency Use Authorization for the shot by year’s end.”

Vaccination and Safety Protocols: From the federal government: Many new answers to questions businesses may have about vaccination status of employees.

About healthcare IT

Northwell Health and Aegis Ventures to form first-of-its-kind artificial intelligence venture to drive better, more equitable, and lower-cost healthcare: “-Northwell Health, New York’s largest healthcare provider, and Aegis Ventures, a New York-based startup studio, today announced they are forming a joint venture (JV) that will ideate, launch, and scale AI-driven companies to address healthcare’s most challenging quality, equity, and cost problems. The JV will assemble leading medical, technology, and business resources to create a first-of-its-kind company creation platform for healthcare innovation. Aegis Ventures intends to invest at least $100 million of seed-stage funds through the platform to catalyze a significant multiple of that amount from the venture capital and investment community.
The JV will work with stakeholders across the Northwell system to create new patient care solutions through collaboration with frontline clinicians, working side-by-side from ideation to implementation, to develop innovations that use AI to predict, diagnose, and manage health conditions. The parties have already started work on solutions related to improving maternal health outcomes and chronic disease prediction.”

About pharma

Opioid Makers Win Major Victory in California Trial: “Four manufacturers of prescription opioids won the pharmaceutical industry’s first major legal victory in the opioid crisis, turning aside claims by local California governments that they contributed substantially to the epidemic…
’There is simply no evidence to show that the rise in prescriptions was not the result of the medically appropriate provision of pain medications to patients in need,’ wrote Judge Peter Wilson of Orange County State Superior Court, who presided over a four-month bench trial.
The manufacturers include Johnson & Johnson, which has a nationwide opioids settlement offer pending; Teva, a maker of generic opioids based in Israel; Allergan, a subsidiary of AbbVie; and Endo Pharmaceuticals.”

Federal judge rules HHS' efforts to punish pharma over 340B restrictions 'arbitrary and capricious': “The pharmaceutical industry scored a muted win in its long-running feud with the Department of Health and Human Services (HHS) over 340B program discounts Friday when a federal court judge granted Eli Lilly’s bid to vacate two administrative actions aimed at drugmakers.
U.S. District Court Judge Sarah Evans Barker ruled that a December advisory opinion from HHS’ Office of the General Counsel and a May enforcement letter from the Health Resources and Services Administration (HRSA) were ‘arbitrary and capricious’ and in violation of the Administrative Procedures Act.
But while Barker ordered the two actions to be set aside and vacated, she also specified that HHS did not exceed its statutory authority or act unconstitutionally in regard to the May enforcement letter.”

About hospitals and health systems

National Hospital Flash Report: October 2021: Among the highlights: “High numbers of high-acuity patients coupled with escalating expenses continued to stress the nation’s hospitals and health systems in September. Actual hospital operating margins remained close to the prior month’s levels. The median Kaufman Hall Operating Margin Index was 3.2% in September, not including federal CARES Act funding. With the aid, it was 4.1%…
Expenses continued to climb. Total Expense per Adjusted Discharge was up 2.6% YTD and 12.9% YOY. Labor expenses rose across all measures even as the number of hospital workers per patient bed declined, reflecting higher pay as hospitals compete for healthcare professionals amid nationwide labor shortages. Non-labor expenses also rose due to significant increases in drug and supply expenses driven in part by worldwide supply chain issues.”

About the public’s health

Every Country Affected: The Tobacco Industry Used the COVID-19 Pandemic to Build Influence With Governments in 80 Countries: “A new report from tobacco industry watchdog STOP reveals that the tobacco industry embraced the COVID-19 pandemic as an opportunity to gain influence, meddle in life-saving health policies and secure preferential treatment. Reports from civil society organizations in 80 countries, analyzed in the Global Tobacco Industry Interference Index 2021, show that no country was immune to the industry’s efforts to use lobbying and donations, often connected to pandemic response, to its advantage…”
Among the specific findings: “Although tobacco is an addictive and harmful product, at least ten governments deemed the tobacco industry and cigarettes to be ‘essential’ during the pandemic or a vital part of their economic recovery efforts, including Bangladesh, Brazil, Jordan, Malaysia, New Zealand, Peru and Sudan.
Countries that have not signed the global treaty, the World Health Organization Framework Convention on Tobacco Control (FCTC), face high levels of industry meddling. These include Argentina, the Dominican Republic, Indonesia, Switzerland and the U.S.A.” [Emphases in the original]

About healthcare devices

DRH Proposed Guidances for Fiscal Year 2022 (FY2022): This past week, the FDA’s Center for Devices and Radiological Health (CDRH) published proposed and finalized guidelines for which it is interested in receiving external feedback. Among the targeted areas is Clinical Decision Support Software.

A smart knee implant promises to ‘help write the future of orthopedic technology.’ Surgeons aren’t so sure: Is newer, smarter technology better technology?
“Last month, surgeons implanted the first of a new, souped-up knee implant, developed by Zimmer Biomet as a way to passively collect data about recovery after one of medicine’s priciest and most common procedures…
But the surgeons who will need to embrace the implant caution that while the device has potential, insights are likely far off — if the data turns out to be useful at all.
’Technology has to be proven that it’s going to improve outcomes in order to be used,” Calin Moucha, the chief joint replacement surgeon at the Mount Sinai health system in New York said. “So, you know, even though this sounds like a cool idea … this isn’t going to improve our outcomes.’”

The US Copyright Office just struck a blow supporting the right to repair: “The US Copyright Office is expanding a legal shield for fixing digital devices, including cars and medical devices. This morning, the office submitted new exemptions to Section 1201 of the Digital Millennium Copyright Act, which bars breaking software copy protection. The resulting rules include a revamped section on device repair, reflecting renewed government pressure around “right to repair” issues.
The Register of Copyrights recommends Section 1201 “anti-circumvention” exemptions every three years, a process that has offered legal protections for everything from unlocking cellphones to ripping DVD clips for classroom use. In addition to renewing these and several other exemptions, this latest rulemaking adopts repair-related proposals from the Electronic Frontier Foundation, iFixit, and other organizations.”

EU orders Illumina to keep Grail a separate company: “Illumina announced on Aug 18 that it had completed its acquisition of Grail even though the Commission, which oversees EU competition policy, had not completed its investigation into the merger. That review is currently set to run until Feb. 4….
The measures provide that Grail be kept separate from Illumina and run by independent managers, that the two companies do not share confidential information, the interactions be kept at arms length and that Grail work on alternative options in case the Commission rejected the merger.”

About health insurance

Biden administration doubling down on ACA open enrollment outreach campaigns with health equity in mind: “The Biden administration has extended the Affordable Care Act (ACA) open enrollment period by one month and invested in a more robust outreach campaign as part of its efforts to bolster the legislation.
The Centers for Medicare & Medicaid Services (CMS) kicked off Monday the start of the HealthCare.gov open enrollment period, which has been extended to Jan. 15, 2022…
’Four out of five consumers will be able to find plans for $10 per month or less with this newly expanded financial assistance,’ Brooks-LaSure said during a call with reporters Monday.”
A significant problem that remains is the out-of-pocket expenses.

1 in 3 insured workers would consider leaving jobs if health insurance weren’t a factor: “Key findings

  • One in three workers (either full-time or part-time) with health insurance (33%) said they would be very or somewhat likely to leave their jobs in the near future if health insurance wasn’t a factor.

  • 26% of Americans with health insurance would be very or somewhat likely to start their own business if health insurance wasn’t a factor.

  • People who get most of their health insurance information from social media are much more likely to have ever avoided testing (39% of those getting most of their health insurance information from social media vs. 14% of those relying most on other sources) and care (22% vs. 8%) for COVID-19.

  • A combined 70% of Americans either don’t know whether you can get financial assistance to get a plan from the federal health insurance marketplace (61%) or believe you cannot (9%).”

Geisinger to pay $18.5M to settle allegations of fraudulent billing: “Danville, Pa.-based Geisinger Community Health Services will pay $18.5 million to resolve allegations that it improperly billed Medicare for hospice and home health services, the Justice Department said Nov. 1.
The settlement resolves self-disclosed violations of Medicare billing rules and includes filings submitted by Geisinger between January 2012 and December 2017.
According to the voluntary disclosure, the billing errors were related to Medicare rules involving physician certifications of terminal illness, patient elections of hospice care and physician face-to-face encounters with home health patients.”

Medicare drops end-stage renal disease payment rule that aims to close health equity gaps: “The Centers for Medicare & Medicaid Services (CMS) finalized a rule that updates payment rates for the End-Stage Renal Disease Prospective Payment System (ESRD PPS) and makes changes to the quality incentive program and the ESRD Treatment Choices (ETC) model. The goal of the changes is to encourage dialysis providers to decrease disparities in home dialysis and transplant rates, part of a larger effort by the Biden administration.
It marks the first CMS Innovation Center model to directly address health equity.” [Emphasis added]

Texas Medical Association files suit against surprise billing rule's 'unlawful' arbitration process: “The Texas Medical Association (TMA) has brought a lawsuit against the Biden administration arguing that the interim final rule on surprise billing goes against the intent of Congress and will ultimately harm patients.
Filed Thursday in the U.S. District Court for the Eastern District of Texas, the case (PDF) is an escalation of the broad pushback the Department of Health and Human Services (HHS) received from providers after releasing the interim final rule in late September.”

Teladoc ramping up focus on virtual primary care with plans to take on financial risk: “During the company's third-quarter earnings call last week, Teladoc CEO Jason Gorevic said the company will take on degrees of risk, from clinical measures of care to risk corridors to, ultimately, full capitation.”

Today's News and Commentary

About Covid-19

Laboratory-Confirmed COVID-19 Among Adults Hospitalized with COVID-19–Like Illness with Infection-Induced or mRNA Vaccine-Induced SARS-CoV-2 Immunity — Nine States, January–September 2021: From the CDC: “Among COVID-19–like illness hospitalizations among adults aged ≥18 years whose previous infection or vaccination occurred 90–179 days earlier, the adjusted odds of laboratory-confirmed COVID-19 among unvaccinated adults with previous SARS-CoV-2 infection were 5.49-fold higher than the odds among fully vaccinated recipients of an mRNA COVID-19 vaccine who had no previous documented infection (95% confidence interval = 2.75–10.99)…
All eligible persons should be vaccinated against COVID-19 as soon as possible, including unvaccinated persons previously infected with SARS-CoV-2.” [Emphasis added]

COVID-19′s global death toll tops 5 million in under 2 years: “Together, the United States, the European Union, Britain and Brazil — all upper-middle- or high-income countries — account for one-eighth of the world’s population but nearly half of all reported deaths. The U.S. alone has recorded over 745,000 lives lost, more than any other nation.”

Sanofi-GSK COVID-19 Shot Will Cost Around $11: “Sanofi is planning to price its recombinant protein-based COVID-19 vaccine developed with a GlaxoSmithKline (GSK) adjuvant at approximately $11 a dose.
Phase 3 trials on a reformulated version of the Sanofi-GSK vaccine candidate began in May and the companies are now also assessing booster jabs. Full trial results are expected by year’s end.”

About hospitals and health systems

How CHS, HCA, Tenet and UHS fared in Q3: A good summary of the reports from these four systems. Profitability is picking up even as hospitals repay Medicare advances.

Cost of Caring: From the AHA. A few highlights, though the entire monograph is worth reading:

  • “In recent years, health care spending growth has largely been driven by increased use and intensity of services.”

  • The highest cost for hospitals is still wages and benefits (at 56% of the total).

  • The AHA makes its case that insurance premiums are not rising because of hospital expenses: “Hospital price growth averaged 2.0% annually from 2010 until the beginning of the COVID-19 pandemic. Health insurance premiums, however, have increased 4.4% per year on average since 2010.”

About healthcare quality

Cardiovascular Safety Communications After US Food and Drug Administration Approval of Contemporary Cancer Therapies: “In this evaluation of contemporary FDA-approved cancer therapeutics, more than 1 in 4 required a cardiotoxic effects safety warning, including more than 40% targeted and immune-based drugs. In postmarketing, the median time to CVD warning issuance was nearly 5 years, a value 40% longer than noncardiac warnings. This pattern remained, even after accounting for the presence or absence of preceding safety reports.”

Watch Out for These Diagnostic Pitfalls: “…researchers looked both at where the diagnosis went wrong as well as the contributing factors that made the diagnosis harder than usual. They ended up analyzing 836 diagnostic cases…
The Top 10 missed diagnoses, in order of frequency from highest to lowest, were:

Colorectal cancer
Lung cancer
Breast cancer
Myocardial infarction
Prostate cancer
Stroke
Sepsis
Bladder cancer
Pulmonary embolism
Brain hemorrhage
In terms of where things went wrong in the process, failure to order a needed test was the most frequent issue, followed by failure to consider the correct diagnosis, failure to or delay in follow-up for an abnormal test result, failure to heavily weigh a critical piece of the patient's history, and failure or delay in ordering a referral.”

About health insurance

Tracking Health Insurance Coverage in 2020-2021: From HHS:

  • “Recent survey data suggest a stable uninsured rate in 2020 despite the pandemic and related recession, with estimates ranging from 8.6 percent to 9.7 percent of the population (28.0 million to 31.6 million people).

  •   Examination of other available data sources provides insights about changes in coverage by source and the overall stability of insurance rates in 2020. Administrative data over the same period suggest that increases in Medicaid and Marketplace enrollment roughly offset decreases in employer coverage, potentially explaining the survey findings.

  •   More recent administrative data in 2021 show ongoing gains in Medicaid (1.7 million between January and April 2021) and Marketplace coverage (1.6 million between August 2020 and August 2021), which suggest that the uninsured rate may be lower now than it was in early 2021.

  •   Uninsured rates continue to be higher in certain populations, including Latinos (18.3 percent) and Blacks (10.4 percent), people with incomes below the poverty level (17.2 percent), and residents of states that have not expanded Medicaid (17.6 percent).”

ACA Marketplaces Became Less Affordable Over Time For Many Middle-Class Families, Especially The Near-Elderly: “In 2015 half of this middle-class population would have paid at least 7.7 percent of their income for the lowest-cost bronze plan; in 2019 they would have paid at least 11.3 percent of their income. By 2019 half of the near-elderly ages 55–64 would have paid at least 18.9 percent of their income for the lowest-cost bronze plan in their area. The American Rescue Plan Act temporarily expanded tax credit eligibility for 2021 and 2022, but our results suggest that families with incomes of 401–600 percent of poverty will again face substantial financial burdens after the temporary subsidies expire.”

About healthcare IT

Wearable device signals and home blood pressure data across age, sex, race, ethnicity, and clinical phenotypes in the Michigan Predictive Activity & Clinical Trajectories in Health (MIPACT) study: a prospective, community-based observational study: “Wearable technology has rapidly entered consumer markets and has health-care potential; however, wearable device data for diverse populations are scarce. We therefore aimed to describe and compare key wearable signals (ie, heart rate, step count, and home blood pressure measurements) across age, sex, race, ethnicity, and clinical phenotypes…”
Among the findings: “Blood pressure and resting heart rate varied by sex, age, race, and ethnicity, with higher blood pressures in males and lower heart rate in participants aged 65 years or older (p<0·0001). Participants took 7511 steps per day (SD 2805) and walked 6009 metres per day (SD 2608), varying across demographic and clinical subgroups.”

DATA PROTECTION REPORT 2021: Among the findings:
Average cost of a data breach has grown from $7.91m in 2018 to $9.05m so far in 2021.
More than 50% of business leaders said they do not have a response plan to a breach.
40% of breaches are caused by external partners and almost 25% by employee error.

About the public’s health

Fetal Mortality Drops to Historic Low of 5.70 Per 1,000 in 2019: “The fetal mortality rate at 20 or more weeks of gestation in the United States was 5.70 per 1,000 live births or fetal deaths in 2019, down 3 percent from 2018, according to the Oct. 26 National Vital Statistics Reports, a publication from the U.S. Centers for Disease Control and Prevention.”

About pharma

Merck Announces Withdrawal and Refiling under the Hart-Scott-Rodino Act and Extension of Tender Offer to Acquire Acceleron Pharma Inc.: “Merck has elected to withdraw its Premerger Notification and Report Form, which was initially filed on October 14, 2021, to provide the Federal Trade Commission (the "FTC") with additional time for review, and expects to refile such form on or about November 1, 2021. Following the refiling, the waiting period applicable to the pending acquisition will expire at 11:59 p.m., Eastern time, on or about November 16, 2021. The acquisition is expected to close in the fourth quarter of 2021.”

Today's News and Commentary

About Covid-19

FDA authorizes Pfizer-BioNTech vaccine for children 5 to 11: “The Food and Drug Administration’s emergency clearance is for a two-shot regimen administered three weeks apart. The dose, 10 micrograms, is one-third that used for adolescents and adults. In a clinical trial of 5- to 11-year-olds, the vaccine was almost 91 percent effective at preventing covid-19, the illness caused by the virus. The vaccine’s safety was studied in about 3,100 children who received the shot and had no serious side effects, the agency said.”

Community transmission and viral load kinetics of the SARS-CoV-2 delta (B.1.617.2) variant in vaccinated and unvaccinated individuals in the UK: a prospective, longitudinal, cohort study: “Vaccination reduces the risk of delta variant infection and accelerates viral clearance. Nonetheless, fully vaccinated individuals with breakthrough infections have peak viral load similar to unvaccinated cases and can efficiently transmit infection in household settings, including to fully vaccinated contacts. Host–virus interactions early in infection may shape the entire viral trajectory.”

Supreme Court upholds vaccine mandate for Maine health-care workers that does not include religious exemption: “The Supreme Court Friday turned down a request from a group of Maine health-care workers to block a state coronavirus vaccination mandate that does not contain an exception for religious objectors.
Three conservative justices dissented from the decision. While the majority did not give a reason for denying the request, Justice Neil M. Gorsuch wrote that the workers deserved an exemption.”

Federal rule in the works could force unvaccinated workers to pay for their COVID-19 tests: “A federal vaccination mandate currently under review for private companies could allow employers to make workers who refuse to get the shot pay for required COVID-19 testing and masks.”

About pharma

J&J to Pay $297 Million to Settle Texas Opioid Lawsuits: “Johnson & Johnson (J&J) has agreed to pay $297 million to Texas by year’s end to settle claims over the company’s alleged role in the state’s opioid epidemic if enough local governments approve the settlement.
The proposed deal is independent from a proposed $26 billion national opioid settlement negotiated with the three largest U.S. drug distributors — McKesson, Cardinal Health and AmerisourceBergen — and drugmaker J&J, who agreed to pay $5 billion over nine years under its terms.”

Why do placebos work? Scientists identify key brain pathway: The study used functional MRI readings:
Both the placebo and nocebo[when patients are told a placebo has harmful side effects] influenced activity in the brainstem, the researchers report this week in The Journal of Neuroscience. The placebo effect increased activity in an area called the rostral ventromedial medulla, which relays pain information, and decreased activity in the periaqueductal gray, which helps the body suppress pain. The nocebo effect induced the opposite change. (The findings may seem counterintuitive, but multiple areas of the brainstem act in complex ways when it comes to creating the sensation of pain, the authors say.)”

About healthcare IT

FDA releases ‘guiding principles’ for AI/ML device development: “The FDA, along with its U.K. and Canadian counterparts, said the principles are intended to lay the foundation for Good Machine Learning Practice…
The principles are:  

  1. The total product life cycle uses multidisciplinary expertise.

  2. The model design is implemented with good software engineering and security practices.

  3. Participants and data sets represent the intended patient population.

  4. Training data sets are independent of test sets.

  5. Selected reference data sets are based upon best available methods.

  6. Model design is tailored to the available data and reflects intended device use.

  7. Focus is placed on the performance of the human-AI team.

  8. Testing demonstrates device performance during clinically relevant conditions.

  9. Users are provided clear, essential information.

  10. Deployed models are monitored for performance, and retraining risks are managed.”

Hacker breached Massachusetts systems' emails for 6+ months; 200,000+ individuals affected: “Worcester-based UMass Memorial Health began notifying more than 200,000 patients and health plan participants that a hacker breached employee email accounts containing their personal information, according to data the health system shared with HHS…”

About the public’s health

US lowers cutoff for lead poisoning in young kids: “The more stringent standard announced Thursday by the Centers for Disease Control and Prevention means the number of children ages 1 to 5 considered to have high blood lead levels will grow from about 200,000 to about 500,000. 
Some experts think the change was overdue. The CDC last changed the definition nine years ago and pledged to consider an update every four years. But work on a revision hit obstacles during the Trump administration, said Patrick Breysse, who heads the CDC’s National Center for Environmental Health.”

No chocolate or ice cream ads for kids as Spain tackles obesity: A lesson for the US?
”Spain will ban advertising of unhealthy foods and drinks like chocolate, biscuits and ice cream aimed at children to help fight obesity in young people, the consumer affairs minister said on Thursday.”

About health insurance

Molina sees 22% dip in net income despite revenue growth in Q3: “Molina Healthcare's total revenue was up over $2 billion from 2020's third quarter, currently sitting at $7 billion.
However, profits were down this quarter, with the insurer reporting a net income of $143 million. This is a 22 percent decrease from 2020's $185 million in profits during the same quarter.”
Most insurers have remained profitable this year due to a reduction in elective procedures.

The More Things Change, the More They Stay the Same: An Analysis of the Generosity of Employment-Based Health Insurance, 2013–2019: From EBRI: “In this paper we explore trends in actuarial value — or relative generosity of health plans — in the employment-based health coverage market since the implementation of the major coverage provisions of the Affordable Care Act (ACA) in 2014. Because there is a concern that workers would migrate to lower actuarial value (AV) plans in the exchanges if the Biden Health Care Plan were adopted, it is also important to know whether workers are already enrolling in lower AV plans in the employment-based market as a result of the ACA. In our analysis, we observe:

  • Both average and median AV were about 83 percent in each year from 2013 to 2019.

  • There were differences in average AV by plan type. The average AV for enrollees in health maintenance organizations (HMOs)/exclusive provider organizations (EPOs) was highest. This was followed by the AV of enrollees in fee-for-service plans. Preferred provider organization (PPO) and point of service (POS) enrollees saw an average AV of 85 percent and 84 percent, respectively. Not surprisingly, plans linked to spending accounts had the lowest AVs.

  • Average AV increased for every type of health plan between 2013 and 2019.

  • We did not find that demographics significantly affected plan choice.

  • We did find variation in AV by industry. Workers in retail trade, agriculture, forestry, fishing, construction, finance, insurance, and real estate are in the lowest AV plans.

    As opposed to group coverage, health insurance purchased in the individual market tends to be somewhat less generous in benefits, on average.”

In other words, employer-sponsored health insurance has remained as generous as it was when the ACA was implemented.

About healthcare regulations

HHS Moves to Undo Trump’s Retrospective Review of Agency Rules: “The Health and Human Services Department on Thursday moved to withdraw or repeal a last-minute Trump administration rule that would have caused health regulations to expire if they weren’t reviewed every 10 years.
The HHS released a proposal that would do away with the rule, (RIN 0991-AC24), which was published in the Federal Register on Jan. 19, one day before President Joe Bidentook office. Under the rule, the HHS would have had five years to assess regulations that are more than 10 years old, and the department could have extended that deadline one time per regulation, for up to a year.
The final rule exempted certain Food and Drug Administration regulations and annual Affordable Care Act rules, in addition to procedural rules, regulations issued jointly with other agencies, and regulations around internal management.”



Today's News and Commentary

About Covid-19

Cheap antidepressant shows promise treating early COVID-19: “The pill, called fluvoxamine, would cost $4 for a course of COVID-19 treatment. By comparison, antibody IV treatments cost about $2,000 and Merck’s experimental antiviral pill for COVID-19 is about $700 per course. Some experts predict various treatments eventually will be used in combination to fight the coronavirus.”

The impact of school opening model on SARS-CoV-2 community incidence and mortality: “After controlling for case rate trends before school start, state-level mitigation measures and community activity level, SARS-CoV-2 incidence rates were not statistically different in counties with in-person learning versus remote school modes in most regions of the United States. In the South, there was a significant and sustained increase in cases per week among counties that opened in a hybrid or traditional mode versus remote…”

Thermo Fisher Scientific’s Saliva-Based COVID-19 Test Gets EUA: “The saliva collection devices are self-contained systems that provide sample consistency and long-term stability. The samples can be shipped and stored at ambient temperatures with no degradation in quality, the company said.
Thermo Fisher’s SDNA saliva collection devices protect DNA and RNA transcripts postcollection to help ensure accurate test results from 2 mm of saliva.”

Tennessee lawmakers aim to protect physicians who use unapproved COVID treatments: “Tennessee state Reps. Debra Moody and Chris Todd have proposed legislation that would prevent punishment of physicians who recommend treatments for COVID-19 that have not been approved by the FDA to treat the disease…”

More Than 8 in 10 Unvaccinated Americans Don’t Want a COVID Vaccine: “New data from the COVID Behaviors Dashboard, developed by the Johns Hopkins Center for Communication Programs, show that 83 percent of those who remain unvaccinated against COVID-19 in the United States have little or no interest in ever getting a vaccine.  
The findings, collected from more than one million people surveyed in the United States in September, suggest that many Americans have made up their minds, leaving them and those around them at higher risk of dying from COVID-19…”

Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States: The latest from the CDC. Among the recommendations is one that immunocompromised people may need a 4th dose.

Merck signs pact to broaden generic manufacturing of COVID-19 pill: “Merck & Co has signed a licensing agreement with the United Nations-backed Medicines Patent Pool (MPP) that will allow more companies to manufacture generic versions of its experimental oral antiviral COVID-19 treatment…”

About health insurance

Kaiser defrauded Medicare of $1B, Justice Department alleges: “Oakland, Calif.-based Kaiser Permanente and various affiliates defrauded Medicare of about $1 billion by adding diagnoses to patients' medical records to increase reimbursement, the Justice Department alleged in a complaint filed Oct. 25. 
The Justice Department alleges that Kaiser physicians submitted inaccurate diagnosis codes for Medicare Advantage beneficiaries from 2009 through 2018.”

Association of Expanded Health Care Networks With Utilization Among Veterans Affairs Enrollees: “Individuals who lived 40 or more miles away from a VA facility were automatically eligible for an expanded health care network through non-VA practitioners (VA community care); those living less than 40 miles away from a VA facility were not automatically eligible…
In this study, expanded network access was associated with increased total health care utilization among affected enrollees in the VA.”
The results are probably not a surprise, but gives the magnitude of the accessibility problem for veterans.

Aetna launches Gene-Based, Cellular and Other Innovative Therapies (GCIT) designated network: “Aetna , a CVS Health company (NYSE CVS), announced the launch of its designated Gene-based, Cellular, and Other Innovative Therapies (GCIT) network. This network is designed to enable members' access to new therapies that treat and potentially cure rare genetic diseases, while helping to manage the high cost of these therapies. Aetna's national GCIT network includes access to more than 75 designated GCIT service providers that have demonstrated quality and value in the delivery of GCIT services…
Beginning January 1, 2022, Aetna's designated GCIT network will provide three gene therapy services, including Luxturna, Spinraza and Zolgensma for the treatment of inherited retinal disease and spinal muscular atrophy. The GCIT network is included as a standard medical benefit in all Aetna fully insured plans and is also available to self-insured plans.”
If all pending treatments are FDA approved, Aetna expects these gene therapies will add an extra $45 trillion to healthcare prices between 2020 to 2024.”
In a related article: NIH, FDA and 15 private organizations join forces to increase effective gene therapies for rare diseases: “The newly launched Bespoke Gene Therapy Consortium (BGTC), part of the NIH Accelerating Medicines Partnership (AMP) program and project-managed by the Foundation for the National Institutes of Health (FNIH), aims to optimize and streamline the gene therapy development process to help fill the unmet medical needs of people with rare diseases.

UnitedHealthcare alleges TeamHealth exaggerated ER care: “Health insurance company UnitedHealthcare is suing TeamHealth, a company that staffs hospital emergency rooms, alleging TeamHealth billed for more expensive ER services that didn't match the care doctors actually provided…
UnitedHealthcare analyzed ER claims and records from TeamHealth, saying they found 62% of TeamHealth's claims involving the highest-paying ER codes were unjustified by notes in medical records.”

Medicare Punishes 2,499 Hospitals for High Readmissions: “In its 10th annual round of penalties, Medicare is reducing its payments to 2,499 hospitals, or 47% of all facilities. The average penalty is a 0.64% reduction in payment for each Medicare patient stay from the start of this month through September 2022. The fines can be heavy, averaging $217,000 for a hospital in 2018, according to Congress’ Medicare Payment Advisory Commission, or MedPAC. Medicare estimates the penalties over the next fiscal year will save the government $521 million. Thirty-nine hospitals received the maximum 3% reduction, and 547 hospitals had so few returning patients that they escaped any penalty.”
Look Up Your Hospital: Is It Being Penalized By Medicare?

Drug pricing, most Medicare expansions are out of Biden's economic bill: A good summary of the latest compromises.

About the public’s health

HHS pledges more effort, resources toward harm reduction for drug users: “Health and Human Services Secretary Xavier Becerra outlined the Biden administration’s strategy for curbing drug overdoses Wednesday, committing more federal support for harm reduction techniques such as distribution of clean syringes and test strips used to check street drugs for hidden fentanyl.
The four-part strategy also includes measures to prevent drug addiction, in part by continuing to reduce the inappropriate prescribing of opioids; expanding medication-based treatment, which research has shown to be the most effective approach; and improving support for people recovering from substance use disorder.”

Phthalate and novel plasticizer concentrations in food items from U.S. fast food chains: a preliminary analysis: “A selection of popular fast food items sampled in this study contain detectable levels of replacement plasticizers and concerning ortho-phthalates. In addition, food handling gloves contain replacement plasticizers, which may be a source of food contamination. These results, if confirmed, may inform individual and regulatory exposure reduction strategies.”

􏰑Federal Trade Commission Cigarette Report 2020: Cigarette sales increased by 800 million units from 2019 to 2020, the first increase in twenty years. Advertising and promotional expenses also increased during that time. Of note is the report did not include vaping products.

About hospitals and health system

CHS sees profit rise, faces lawsuit over Quorum bankruptcy: “Franklin, Tenn.-based Community Health Systems, which operates 83 hospitals in 16 states, saw revenues decline in the third quarter of this year but ended the period with higher net income. The hospital operator released its third-quarter earnings two days after being sued over the 2020 bankruptcy of a company it spun off…
CHS released its quarterly earnings a few days after being sued over the 2020 bankruptcy of Quorum Health, a company it spun off in 2016. The complaint, filed Oct. 25, alleges actions by CHS and Credit Suisse Group burdened Quorum with more than $1.2 billion in debt. CHS tapped Credit Suisse as an adviser during the spinoff…”

About healthcare IT

TransUnion divests RCM unit in $1.74B deal: “nThrive, a healthcare revenue cycle management software-as-a-service platform, has signed a definitive agreement to acquire TransUnion Healthcare, the healthcare data and analytics business of TransUnion.”

About pharma

In the Midst of COVID-19 Crisis, 7 out of 10 Big Pharma Companies Spent More on Sales and Marketing than R&D: “The AHIP analysis examined the 10 largest pharmaceutical companies by revenue in 2020. Using pharmaceutical companies’ own annual reports and other financial filings…
Of the 10 drug manufacturers examined, 7 of them spent more on selling and marketing expenses than they did on research and development. For this group of 10 companies alone, selling and marketing expenses exceeded R&D spending by $36 billion, or 37%. Moreover, this use of dollars occurred during a year dedicated to the development of new treatments and vaccines to overcome the COVID-19 crisis.”
The article has some company specifics.

Today's News and Commentary

About Covid-19

Moderna says its COVID-19 vaccine protective, safe in young children: “Moderna Inc said on Monday its COVID-19 vaccine generated a strong immune response in children aged six to 11 years and that it plans to submit the data to global regulators soon.”

FDA review appears to pave the way for Pfizer-BioNTech vaccine for children 5 to 11: “The review found that for four scenarios that were weighed, “the benefits of the Pfizer-BioNTech COVID-19 Vaccine 2-dose primary series clearly outweigh the risks.” But in one, when the virus was at its lowest levels, there could be more hospitalizations related to a rare heart side effect associated with the vaccine than the number of hospitalizations prevented from covid-19, the illness caused by the virus.
Even then, the review found, “the overall benefits of the vaccine may still outweigh the risks under this lowest incidence scenario”because of how hospitalized cases of the two conditions differ. The vaccine-related myocarditis cases have tended to resolve in a few days, unlike covid-19 infections, which can lead to death.”

White House: We don’t have ‘unlimited rights’ to Moderna vaccine recipe: Despite significant federal support…”The Biden administration has concluded that it lacks the authority to share details of Moderna’s vaccine process, two senior administration officials told The Washington Post, after a months-long legal review.”

US will require foreign travellers to get WHO-authorised vaccines: “Under the rules, which will take effect in two weeks’ time, anyone who has been inoculated with one of the seven vaccines authorised by the WHO will be allowed to enter the US by land or air. They include the Sinovac and Sinopharm vaccines, which were developed in China, despite the lack of data about their effectiveness against the Delta variant of the coronavirus…
Children under the age of 18, people with allergies to any of the vaccine ingredients and visitors from countries where less than 10 per cent of the population has been vaccinated will all be exempt from the new mandate.”
Policy-makers at all governmental levels (in most places) in this country are trying to get everyone immunized with effective vaccines. How did this travel policy get approved???

EEOC Issues Updated Covid-19 Technical Assistance: “The U.S. Equal Employment Opportunity Commission (EEOC) today posted updated and expanded technical assistance related to the COVID-19 pandemic, addressing questions about religious objections to employer COVID-19 vaccine requirements and how they interact with federal equal employment opportunity (EEO) laws…
The key updates to the technical assistance are summarized below:

  • Employees and applicants must inform their employers if they seek an exception to an employer’s COVID-19 vaccine requirement due to a sincerely held religious belief, practice, or observance.

  • Title VII requires employers to consider requests for religious accommodations but does not protect social, political, or economic views, or personal preferences of employees who seek exceptions to a COVID-19 vaccination requirement.

  • Employers that demonstrate ‘undue hardship’ are not required to accommodate an employee’s request for a religious accommodation.”

Senate confirms Biden pick to lead OSHA as vaccine rule nears: “The U.S. Senate on Monday voted along party lines to confirm California workplace safety chief Doug Parker to lead the Occupational Safety and Health Administration (OSHA), filling the post for the first time in more than four years.”

The Ridiculous Practice That Stopped Some Nurses From Working in a Pandemic: The article provides examples of how non-compete clauses are restricting nurses from practicing in needed areas.

HHS extends shelf life of Eli Lilly's COVID-19 antibody drug: “HHS has extended the shelf life of Eli Lilly's COVID-19 antibody cocktail drug for six more months. 
The drug, a combination of monoclonal antibodies etesevimab and bamlanivimab, can now be refrigerated for 18 months instead of 12…”

About health insurance

Lower premiums, more choices on Obamacare exchanges for 2022 as Democrats battle to extend generous subsidies: “The average premium for the benchmark silver plan in 2022 will decline by 3% a month for the 33 states that are participating in the federal exchange, healthcare.gov, according to the report, issued by the Centers for Medicare & Medicaid Services.
This is the fourth year in a row that premiums have dropped, as insurers are better able to price their policies based on enrollees' health care needs and as the marketplaces become more competitive. The average benchmark plan premium is 10% lower for a 27-year-old and 9% lower for a family of four than in 2018, before subsidies, for example.”
In a related posting from CMS: Marketplace 2022 Open Enrollment Fact Sheet

10 ZIP codes with the highest uninsured rates: FYI

Aetna to shift to digital payments, remittances by September 2022: “Aetna has set a September 2022 goal to move to digital payments, remittances and explanation of benefits statements.
The move began last month, and the payer is encouraging providers to use its Availity provider portal for explanation of benefits statements and direct deposit or virtual credit cards for payments, according to an October newsletter.”

Coalition of employers launches PBM: “A nonprofit coalition of large, private employers has launched a new pharmacy benefit manager named EmsanaRx. 
The Purchaser Business Group on Health, which includes nearly 40 employers, said the new PBM will increase transparency and flexibility for employers. 
The group said EmsanaRx will address the "lack of accountability of the PBM industry to its employer clients, who largely lack access to information about drug costs, true discounts and administrative fees that contribute to huge profits…
The group said EmsanaRx will offer a fixed price per prescription and direct guidance from a dedicated clinical pharmacist account manager partnering with employers to design their own pharmacy network and modify their formulary.”

About the public’s health

Vaping marijuana by teens doubles in last seven years, with potentially harmful consequences, study says: “Marijuana vaping by school-aged youth doubled between 2013 and 2020, a new study found, with reported use within the last 30 days rising seven-fold during the same time period.”

Trends in Mortality Among Pregnant and Recently Pregnant Women in the US, 2015-2019: “All-cause mortality rates for recently pregnant women increased 4.4% annually from 2015 to 2019, mostly attributable to causes other than pregnancy-specific complications, including drug/alcohol poisoning, and the APCs for all-cause and drug/alcohol poisoning mortality rates were greater for recently pregnant women than for the total female population of childbearing age.”

About hospitals and health systems

FTC tightens reins on merger control: 6 things to know: “The Federal Trade Commission announced Oct. 25 it is restoring its practice of requiring companies that previously pursued an anticompetitive merger to get prior approval for future transactions.”
For example: “The FTC is reinstating the prior approval practice after the commission voted in July to repeal a 1995 policy statement that prevented the agency from imposing these merger restrictions.”

UHS grows to 360 hospitals, posts $218M profit in Q3: “King of Prussia, Pa.-based Universal Health Services reported higher revenue but a lower profit in the third quarter of 2021. 
The hospital chain's revenues increased 8.4 percent year over year to $3.2 billion in the third quarter of this year. The company's 360 acute care and behavioral health hospitals contributed to the growth.”
Non-Covid-19 related care contributed to the revenue growth.

About diagnostics

FDA Designates Biological Dynamics’ Pancreatic Cancer Test a Breakthrough Device: “he FDA has designated Biological Dynamics’ liquid biopsy assay, Exo-PDAC (pancreatic ductal adenocarcinoma), as a breakthrough device.
The assay is designed to detect PDAC, an aggressive and lethal form of cancer early in the course of the disease in high-risk adults.”

About healthcare IT

Amazon’s Latest Healthcare Venture: Bringing Alexa To The Patient’s Bedside: Amazon announced its latest venture: integrating and scaling its famous Alexa systems into senior living communities and large healthcare systems…
For senior living facilities, the idea is to develop a stronger sense of community and connectedness: the initiative aims to ‘tailor resident experiences by customizing community information like activity schedules and meal menus. Care team members can communicate more efficiently with residents using Alexa communication features, which enable them to make Announcements, voice and video calls, or send direct audio messages to other Alexa-enabled devices throughout the property.’
For hospital systems, efficiency and communication are key factors: ‘patients can communicate with their care staff, control devices in their room, or stay informed and entertained with news and music, just by asking Alexa. Healthcare providers can communicate with patients quickly and easily with features like calling and Drop In—without the need to enter patient rooms. This enables hospitals to increase productivity, conserve medical supplies and protective equipment, such as masks, gloves, and gowns, and free up staff time to provide more personalized care.’”

Today's news and Commentary

About health insurance

Patient and Payer Incentives to Use Patented Brand-Name Drugs vs Authorized Generic Drugs in Medicare Part D: “The results of this cross-sectional study suggest that authorized generic drugs for insulin and direct-acting antiviral agents may lower out-of-pocket spending for patients but are unlikely to provide savings for Part D plans or Medicare. Instead, these drugs allow manufacturers to offer products at a lower list price without materially lowering net prices or profits.”

Blue Shield of California, Google Cloud to develop real-time claims processing platform: “Together, the companies will create a real-time claims processing platform leveraging automation, artificial intelligence and machine learning technologies. The platform will be designed to streamline the back-end billing processes between Blue Shield of California and the providers it contracts with.
The solution will extract clinical data from the provider’s EMR and then codify that record into a digital claim for billing, said Lisa Davis, senior vice president and chief information officer at Blue Shield of California. The payer will adjudicate that claim and send back a claim settlement decision to the provider, which will be shared with the patient in near real time.”
Currently, the provider bills the payer based on coding criteria. This method, if proved accurate, would remove the subjectivity of billing, reduce administrative cost and decrease turnaround time for adjudication of claims.

A $1,775 Doctor’s Visit Cost About $350 in Maryland. Here’s Why.: An excellent account of the Maryland rate-control system.

About the public’s health

Cost-effectiveness Evaluation of the 2021 US Preventive Services Task Force Recommendation for Lung Cancer Screening: “This economic evaluation found that the 2021 USPSTF recommendation for lung cancer screening was cost-effective; however, alternative screening strategies that maintained a minimum cumulative smoking exposure of 20 pack-years but included individuals who quit smoking within the past 25 years may be more cost-effective and warrant further evaluation.”

CNN Investigation: Tens of millions of filthy, used medical gloves imported into the US: “A months-long CNN investigation has found that tens of millions of counterfeit and second-hand nitrile gloves have reached the United States, according to import records and distributors who bought the gloves -- and that's just the tip of the iceberg. Criminal investigations are underway by the authorities in the US and Thailand.
Experts describe an industry riddled with fraud, with one of them -- Douglas Stein -- telling CNN that nitrile gloves are the "most dangerous commodity on Earth right now."

Qiagen Gets CE Mark for Portable Tuberculosis Test Device: “The device uses blood samples to test for molecules released from T-cells that have come into contact with Mycobacterium tuberculosis, the pathogen that causes TB infections.
Qiagen says it will focus its marketing of the device on regions that face a high burden of TB and where access to laboratories and resources for testing are limited.”


About hospitals and health systems

Association Between Hospital Performance Metrics and Market Share: “The findings of this cross-sectional ecological study suggest that better hospital performance score was associated with larger market share for hip and/or knee replacement and AMI [acute myocardial infarction] procedures but not for CABG [coronary artery bypass graft] The effect size was greater for the elective procedure (hip and/or knee replacement) than for the nonelective procedure (AMI), suggesting that patients may be more able to choose their facility for elective procedures.”

About pharma

FDA withdraws more than 200 ANDAs over unsubmitted annual reports: “Almost two years after proposing to withdraw nearly 250 abbreviated new drug applications (ANDAs) after their manufacturers repeatedly failed to submit the necessary annual reports, the US Food and Drug Administration (FDA) on Thursday said it will withdraw 216 of those applications.”

FDA OKs Higher Numbers of Competitive Generic Therapies in Fiscal 2021: “CGT” is an FDA designation for drugs for which there is inadequate generic competition. Usually this means there’s not more than one approved drug for the indication.
In fiscal 2021, the FDA approved 53 ANDAs for CGT. That’s up from 35 in 2020. Applications were up significantly too. The number of CGT applications received throughout the fiscal year was 507, up from 390 in 2020.”

About Covid-19

CDC director on mask requirements: Need to continue until we can get 'cases down': “Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky on Friday said that mask requirements need to be continued until we can get coronavirus “cases down.”
…Walensky said it was ‘really encouraging’ that the surge in infections from the delta variant is ‘now coming down.’ She added that the U.S. is still averaging 75,000 new infections and 1,200 deaths every day.”

Biden administration takes new steps to boost availability of rapid coronavirus tests: “The Biden administration announced additional steps on Monday to increase the availability of rapid at-home coronavirus tests and bring down their cost.
The biggest change is a $70 million investment by the National Institutes of Health — using funds from the American Rescue Plan, which was passed earlier this year — to help manufacturers navigate the Food and Drug Administration’s regulatory process. The NIH program aims to speed up the authorization process for new tests by helping manufacturers produce the data regulators need. It will also identify rapid tests that have the potential to be produced and distributed on a large scale.”

About healthcare IT

The Lancet and Financial Times Commission on governing health futures 2030: growing up in a digital world: “The Lancet and Financial Times Commission on governing health futures 2030: growing up in a digital world argues digital transformations should be considered as a key determinant of health. But the Commission also presses for a radical rethink on digital technologies, highlighting that without a precautionary, mission-oriented, and value-based approach to its governance, digital transformations will fail to bring about improvements in health for all.”
Look at the comprehensive full report .

Today's News and Commentary

About Covid-19

CDC approves Moderna and J&J Covid vaccine boosters, allowing people to mix-and-match shots: The headline is the story. The approval comes on the heals of the FDA’s recommendation for the same measures.

Covid Live Updates: Pfizer and BioNTech Says Vaccine Is Highly Protective in 5- to 11-Year-Olds: “Pfizer reported data on Friday showing that its coronavirus vaccine had a 90.7 percent efficacy rate in preventing symptomatic Covid-19 in a clinical trial of children ages 5 to 11.
The company submitted the information to the Food and Drug Administration, which was expected to release its own analysis of the data later in the day.
Children in the trial received a dose of 10 micrograms, smaller than the 30-microgram dose given to adults. The company said that the dosage was safe, and that trial participants had seen only mild side effects.”

BNT162b2 [Pfizer–BioNTech] and ChAdOx1 nCoV-19 [AstraZeneca]Vaccine Effectiveness against Death from the Delta Variant: “In summary, we found that the BNT162b2 and ChAdOx1 nCoV-19 vaccines offered substantial protection against death from Covid-19 caused by the delta variant.”
In a related article: Delta variant subtype detected in the US:

Association Between COVID-19 Relief Funds and Hospital Characteristics in the US: “In this cross-sectional study among 952 hospital-level entities, wide ranges existed in CARES Act funding, with 24% of hospitals receiving less than $5 million in funding and 8% receiving more than $50 million. Academic-affiliated hospitals with higher pre–COVID-19 assets and hospitals that had higher COVID-19 cases received higher levels of funding, while critical access hospitals received lower levels of financial assistance.
CARES Act funds may have disproportionately gone to hospitals that were in a stronger financial situation prior to the pandemic compared with those that were not, but funds also went disproportionately to those that eventually had the most cases.”

About pharma

Continuous Manufacturing of Pharmaceuticals Bill Clears House: “The House of Representatives passed a bill in a bipartisan 368-56 vote this week that aims to promote innovation in continuous manufacturing, which is used to produce drugs more efficiently than the conventional batch production process.
The National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act would allocate $100 million in funding from fiscal 2022 to 2026.”
Another purpose of the bill is to reduce reliance on foreign suppliers.

Vertex’s Stem-Cell Therapy Slashed Need for Daily Insulin Infusion: “Vertex Pharmaceuticals said a patient with a 40-year history of Type 1 diabetes experienced a 91 percent reduction in daily insulin dose after an infusion of its VX-880 stem-cell-derived islet cell replacement therapy.
The cells quickly began functioning as normal islet cells. And with this positive news in hand, the company will continue its phase 1/2 program at several sites in the U.S. and Canada, with the goal of submitting an Investigational New Drug application to the FDA in 2022.”

About health insurance

Next Generation Accountable Care Organization (NGACO) Model Evaluation: “As of the fourth performance year, the Next Generation Accountable Care Organization (NGACO) model was associated with $667 million in gross savings in Medicare Parts A and B spending. After factoring in $909 million in shared savings and other payouts to NGACOs, however, the model was associated with $243 million in net losses. On average, NGACOs located in markets with higher per capita Medicare Parts A and B expenditures achieved higher spending reductions, as they had greater opportunities to improve efficiency. Some NGACOs operating in markets with lower Medicare expenditures had pathways to spending reductions. The amount of total spending reductions by NGACOs of differing organizational affiliation were similar, but there were notable differences in the care settings where reductions occurred. NGACOs primarily reduced spending in settings other than their own organizational setting. Physician practice- affiliated NGACOs reduced acute care spending, but did not reduce spending for professional services. By contrast, NGACOs affiliated with hospitals or integrated delivery systems (IDS) reduced spending for professional services.”

Tennessee may have to repay more than $767 million in Medicaid funds: “Tennessee could be forced to repay the federal government $767.5 million in Medicaid funds that auditors said TennCare officials incorrectly claimed between 2009 and 2014, according to a U.S. Health and Human Services inspector general report released Thursday.
The report found that Tennessee did not comply with federal requirements for certain expenses that are supposed to be certified for eligibility for matching federal funds from Medicaid.”

Anthem BCBS, Kroger partner on health plans: “Anthem Blue Cross and Blue Shield is partnering with Kroger Health on Medicare Advantage plans that provide members with in-store benefits at Kroger locations.
The two plans — one HMO dual-eligible special needs plan and one PPO — provide members with a Healthy Groceries Card that gives them $75 a month to use at Kroger, according to an Oct. 21 news release.
Plans also include a quarterly over-the-counter product allowance and access to Kroger's 2,200 pharmacy locations. It also includes a Healthy Pantry benefit that gives members access to 12 monthly meetings with a Kroger Health dietician and delivers monthly healthy pantry staples to their door.”

BMA: Medicare Advantage Offers Lower Costs, Better Benefits Than FFS: “Medicare Advantage plans offer members additional benefits and require less spending from the federal government compared to fee-for-service (FFS) Medicare, according to a report commissioned by Better Medicare Alliance’s Center for Innovation in Medicare Advantage.
The management consulting company Milliman conducted the report by analyzing FFS Medicare and Medicare Advantage cost, enrollment, and benefit data from CMS records.
Milliman found that the federal government spends $949 per person per month on FFS Medicare, including administration costs. Meanwhile, the government spends a total of $943 per person per month on Medicare Advantage, which includes $110 in administration costs and $123 in additional benefits.
On a yearly basis, Medicare Advantage provides $32.5 billion in additional benefits while also offering beneficiaries lower out-of-pocket costs compared to FFS Medicare. Unlike FFS Medicare, Medicare Advantage plans feature an out-of-pocket spending limit.”

CMS Launches Webpage to Share Innovative State Actions to Expand Medicaid Home and Community-based Services: The “Centers for Medicare & Medicaid Services (CMS) launched a new ‘one-stop shop’ for state Medicaid agencies and stakeholders on Medicaid.gov to advance transparency and innovation for home and community-based services…Through this new webpage, state Medicaid agencies and stakeholders can access information about states' plans to enhance, expand, and strengthen home and community-based services across the country using new Medicaid funding made available by the American Rescue Plan Act of 2021 (ARP).”

UnitedHealth to repay providers shortchanged for COVID vaccine administration: “UnitedHealth Group has committed to reprocessing all of its commercial claims related to COVID-19 vaccine administration, after federal investigators confirmed the nation's largest insurer paid "millions" of providers 40% less than the Medicare rate for inoculating patients.”

Iowa privatizing Medicaid resulted in 891% more illegal care denials, report finds: “A report from Rob Sand, Iowa's auditor of state, found that privatizing the state's Medicaid program in 2016 resulted in an 891 percent increase in patients who were allegedly illegally denied care. 
According to the Oct. 20 report, the transition from a Human Services Department-administered program to a managed care system, called IA Health Link, has resulted in a significant shift in Medicaid members appealing a reduction or denial of care.”

Hospitals and health systems

Ascension, AdventHealth to Unwind AMITA Health Partnership: “After working closely together for nearly seven years, AdventHealth and Ascension have decided to unwind their AMITA Health partnership, the joint operating company serving the healthcare needs of residents of the greater Chicago area.
Leaders of both sponsoring organizations have determined that going forward separately is in their collective best interest in order to more nimbly meet the changing needs and expectations of consumers in the rapidly evolving healthcare environment.”
No further information is available about the breakup.

HCA's profit more than triples to $2.3B in Q3: “Nashville, Tenn.-based HCA Healthcare saw strong growth in revenue and profit in the third quarter of 2021 compared to the same period last year. 
The 183-hospital system posted revenue of $15.3 billion in the quarter ended Sept. 30, up 14.8 percent from the $13.3 billion recorded in the third quarter of 2020.

Oak Street Health Acquires Virtual Specialty Care Provider RubiconMD: Oak Street Health, Inc. ( a network of value-based primary care centers for adults on Medicare), today announced it has acquired RubiconMD, the leading technology platform providing access to specialist expertise. The deal enables Oak Street Health to integrate virtual specialty care into its existing care model, which significantly streamlines the referral process and better manages costs, enhances patient experience, and provides comprehensive care far beyond traditional primary care.
RubiconMD’s specialist network of over 230 specialists covers all major specialties, including Cardiology, Nephrology and Pulmonology. RubiconMD provides clinical insights from specialists on specific patient cases, enabling primary care providers to directly manage and coordinate more of a patient’s care needs.”

About healthcare IT

Frequent but fragmented: use of note templates to document outpatient visits at an academic health center: “Templates were used to document 89% of visits, with a median of 2 used per visit. Only 17% of the 100 230 unique templates were ever used by more than one person and most providers had their own full-note templates. These findings suggest template use is frequent but fragmented, complicating template revision and maintenance. Reframing template use as a form of computer programming suggests ways to maintain the benefits of personalization while leveraging standardization to reduce documentation burden.”

FCC awards $40M more in telehealth funding to 71 providers: “The program funds telehealth projects developed by providers across the U.S. This round of funding follows the FCC's $41.1 million disbursement to 72 providers in September. The FCC has committed grants to providers in every state, territory and Washington, D.C.” See the article for a list of grantees.

23andMe buys telemedicine specialist Lemonaid Health: “23andMe Holding Co. said Friday it agreed to pay $400 million for Lemonaid Health Inc., the on-demand platform for accessing medical care and pharmacy services, in a bid to add telemedicine and prescription drug delivery services… 23andMe CEO Anne Wojcicki said the company will combine its business of providing genetic profiles of consumers with giving patients and healthcare providers better information about health risks and treatments."

11 states ink data breach reporting laws after slew of ransomware attacks: The article has details for each of the states.

Today's News and Commentary

About health insurance

More Medicare Advantage Plans Will Offer Non-Medical Benefits in 2022: “…in 2022, the most commonly offered benefit of the 4 that Avalere analyzed is meals (68%), followed by transportation (39%), nutrition (30%), and in-home support services (11%). The percentage of plans offering these types of benefits will increase from 2021 to 2022, with the largest increases for nutrition and in-home support. Smaller increases will occur in the percentage of plans offering meals and transportation.”

Commercial Health Insurance Markups over Medicare Prices for Physician Services Vary Widely by Specialty: “In this study, we assess the variation across physician specialties in commercial markups over Medicare prices for professional services…
Our sample includes 17 physician specialties and approximately 20 services per specialty that represent about 40 percent of total professional spending. We find that family medicine, obstetrics and gynecology, dermatology, ophthalmology, and psychiatry had the lowest commercial markups relative to Medicare prices, averaging about 110 percent of Medicare rates or less. Nine specialties received commercial payments between 120 and 150 percent of Medicare rates, on average. These included gastroenterology, cardiology, general surgery, and orthopedics. Radiology and neurosurgery received commercial payment rates of 180 and 220 percent of Medicare rates, whereas emergency department and critical care specialties received commercial payment rates of 250 percent of Medicare rates. Anesthesia received the highest markup at 330 percent of Medicare rates. Our findings have important implications for debates over physician payment reforms, public option and single-payer policies, and Medicare payment reforms.”

About hospitals and health systems

Tenet's operating income hits $1B in Q3: “Dallas-based Tenet Healthcare saw many of its key financial metrics improve in the third quarter of 2021, according to its financial report released Oct. 20. 
In the third quarter ending Sept. 30, the for-profit hospital system saw its net operating revenue hit $4.9 billion, up 7.4 percent from the $4.6 billion recorded in the same period last year. 
Tenet saw revenue growth in its hospital and ambulatory divisions.”

About healthcare IT

Oak Street Health buys virtual care provider for $130M: “Oak Street Health, a Chicago-based network of primary care centers for Medicare patients, acquired virtual consult platform RubiconMD for $130 million, the company said Oct. 21…
Under the deal, Oak Street Health will integrate RubiconMD's virtual specialty care services into its existing care model.”

About pharma

Pfizer says its vaccine booster restores full protection against COVID-19: “Pfizer and BioNTech said Thursday that a late-stage trial of the drugmakers' COVID-19 vaccine booster showed it restored full protection against the disease. In a test involving 10,000 participants, the additional shot was 95.6% effective against the disease, according to the companies.”

Aduhelm is bombing: “Biogen sold $300,000 worth of Aduhelm in the third quarter, well below Wall Street's expectations, which prompted analysts at Raymond James to call the Alzheimer's drug ‘potentially the worst drug launch of all time’ amid Biogen's ‘persistent hyperbole about the drug's purported benefits.’..
Aduhelm's controversial approval and high price tag have shaped the market reaction. Health insurers are hesitant to cover Aduhelm until Medicare makes a decision next year, and doctors aren't embracingthe drug either.”

New initiative launches to attack problem of substandard generic drug distribution: “ARTiFACTS, creator of the world's first blockchain-based platform for scientific and academic research, today announced a partnership with the Distributed Pharmaceutical Analysis Lab (DPAL) at the University of Notre Dame to develop a prototype solution for tracking pharmaceutical chain-of-custody information in real-time using distributed ledger technology. Working with ARTiFACTS, DPAL will record all physical handling and research metadata starting from the point-of-purchase of prescription drugs and sustained throughout the testing, analysis and reporting requirements.”

About Covid-19

‘They rushed the process’: Vaccine maker’s woes hamper global inoculation campaign: Wonder what happened to Novavax?
”The U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time — in hopes that it would offer the world another option for a safe and effective vaccine to help protect against Covid-19. But the company has consistently run into production problems. The methods it used to test the purity of the vaccine have fallen short of regulators’ standards and the company has not been able to prove that it can produce a shot that is consistently up to snuff, according to multiple people familiar with Novavax’s difficulties.”

COVID vaccine makers brace for a variant worse than Delta: “Over the past few months, all three companies have been running dress rehearsals by practising on known SARS-CoV-2 variants. This involves updating their vaccines to match variants such as Beta and Delta, testing them in clinical studies, tuning their internal workflows and coordinating with regulators. Their goal is to learn from these warm-up trials and smooth out kinks in their processes, so that they can move fast if, or when, a true escape variant emerges.”

In secret vaccine contracts with governments, Pfizer took hard line in push for profit, report says: “A report released Tuesday by Public Citizen, a consumer rights advocacy group that gained access to a number of leaked, unredacted Pfizer contracts, sheds light on how the company uses that power to ‘shift risk and maximize profits,’ the organization argues…
Public Citizen found common themes across contracts, including not only secrecy but also language to block donations of Pfizer doses. Disputes are settled in secret arbitration courts, with Pfizer able to change the terms of key decisions, including delivery dates, and demand public assets as collateral.”

Gates Foundation to spend $120 mln to speed access to generics of Merck COVID-19 pill: “The Bill & Melinda Gates Foundation said on Wednesday it would spend up to $120 million to kick-start development of generic versions of Merck & Co's oral COVID-19 treatment to help ensure lower-income countries have equal access to the drug.”

About health technology

In a First, Surgeons Attached a Pig Kidney to a Human, and It Worked: “Surgeons in New York have successfully attached a kidney grown in a genetically altered pig to a human patient and found that the organ worked normally, a scientific breakthrough that one day may yield a vast new supply of organs for severely ill patients…
[S]urgeons at N.Y.U. Langone Health took an astonishing step: With the family’s consent, they attached the pig’s kidney to a brain-dead patient who was kept alive on a ventilator, and then followed the body’s response while taking measures of the kidney’s function. It is the first operation of its kind.”

Largest ever global study of tuberculosis identifies genetic causes of drug resistance: “Using cutting-edge genomic sequencing techniques, researchers at the University of Oxford have identified almost all the genomic variation that gives people resistance to 13 of the most common tuberculosis (TB) drug treatments…
Using two key advances: a new quantitative test for drug resistance and a new approach which identifies all the genetic changes in a sample of drug-resistant TB bacteria the researchers have generated a unique dataset which the team has used to quantify how changes in the genetic code of M. tuberculosis reduce how well different drugs kill these bacteria that cause TB. These innovations, combined with ongoing work in the field, promise to profoundly improve how patients with TB are treated in the future.”

About the public’s health

The 2021 report of the Lancet Countdown on health and climate change: code red for a healthy future: The report is a comprehensive analysis of the health impact of global warming. In addition to such obvious harm as deaths due to excessive heat, other consequences include: “The number of months with environmentally suitable conditions for the transmission of malaria (Plasmodium falciparum) rose by 39% from 1950–59 to 2010–19 in densely populated highland areas in the low HDI group, threatening highly disadvantaged populations who were comparatively safer from this disease than those in the lowland areas…”

Today's News and Commentary

About Covid-19

FDA authorizes Moderna and Johnson & Johnson boosters and says people can get a shot different from their original dose: “The decision by the Food and Drug Administration paves the way for boosters of all three authorized shots to be available to a wide swath of the U.S. population and promises to ease the logistics of the booster campaign for pharmacies and clinics offering vaccines.”

Booster shots could soon be recommended for people as young as 40, source says: “‘I believe it will happen,’ the source familiar with the plan told CNN's Elizabeth Cohen, adding that there is ‘growing concern within the FDA’ that US data is beginning to show more hospitalizations among people under age 65 who have been fully vaccinated.”

J&J says COVID-19 vaccine added $502 million to Q3 sales: The article also has a breakdown of other revenue-producing products.

About healthcare IT

Patients say telehealth is OK, but most prefer to see their doctor in person: In “a poll by NPR, the Robert Wood Johnson Foundation and the T.H. Chan School of Public Health at Harvard that surveyed patients in August and September. Around 42% of respondents said someone in their household had used telehealth. Of those, 82% reported satisfaction, yet nearly two-thirds — 64% — would have preferred to see their nurse or doctor in person.”

A survey of U.S. public perspectives on facial recognition technology and facial imaging data practices in health and research contexts: “Our findings indicate that while a majority of research participants might be comfortable with facial images and facial recognition technologies in healthcare and health-related research, a significant fraction expressed concern for the privacy of their own face-based data, similar to the privacy concerns of DNA data and medical records. A nuanced approach to uses of face-based data in healthcare and health-related research is needed, taking into consideration storage protection plans and the contexts of use.”

Public Health Data Exchange, Health Equity Require Team Effort: “RWJF… announced $50 million in funding for a range of initiatives centered on a national interoperability infrastructure for public health data exchange. Funding will address the following:

  • A grant of $11.5 million to transform local data ecosystems to eliminate systemic racial, structural, and bureaucratic barriers in public health data;

  • A grant of $10 million to support community-academic partnerships with historically black colleges and universities in the Gulf Coast region to expand the interpretation of data to transform local public health data systems; and

  • A grant of $10 million to advance policies to promote more meaningful, nuanced data disaggregation beyond broad racial/ethnic categories to raise awareness about the need to address health disparities.”

Microsoft links with Cerner, Epic to unveil 5 telehealth capabilities: “Microsoft has unveiled several capabilities for virtual healthcare visits, which can be used through Epic and Cerner EHR, according to an Oct. 19 Microsoft Teams blog post.”
For example: “Patients and clinicians can launch telehealth visits through the Microsoft Teams EHR connector for Cerner. Clinicians can launch visits from Cerner PowerChart. The Microsoft Teams EHR connector is also available for patients whose providers use Epic [and] Microsoft will allow clinicians to have scheduled queuing for virtual visits.”

CMS Selects 4 States for ACO-Based Rural Telehealth Delivery Model: “The Centers for Medicare & Medicare Services will provide funding to the University of Alabama at Birmingham (UAB), South Dakota’s Department of Social Services, Texas’ Health and Human Services Commission and the Washington State Healthcare Authority to implement the Community Health Access and Rural Transformation (CHART) model. Those organizations will develop telehealth and other services through an ACO transformation tracks that leverages value-based payment models.”

About health insurance

Three articles in the news today about administrative simplification in healthcare. The first one is from McKinsey and the other two appeared in JAMA Network.

Administrative simplification: How to save a quarter-trillion dollars in US healthcare
Administrative Simplification and the Potential for Saving a Quarter-Trillion Dollars in Health Care
Administrative Expenses in the US Health Care System:Why So High?

Bipartisan senators fire warning shot against any cuts to Medicare Advantage: “The group of 13 senators—including seven Democrats, five Republicans and one independent—wrote a letter Friday to Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure on building progress for the program. But the senators warned Brooks-LaSure of any cuts to the program.”

ACA extras would cost $553B, extend coverage to 4 million people, budget office says: “A letter from the Congressional Budget Office found that expanding the ACA — including tax credits, eligibility and Medicaid programs in holdout states — would cost $553 billion. 
The price tag would extend coverage to 4 million people, according to the Oct. 19 letter.”

Q3 report shows Anthem profits up 580%: 5 things to know: “The insurer recorded $1.51 billion in profits, anchored by an 16 percent increase in operating revenue to $35.5 billion.”

About the public’s health

Incidence of Cigarette Smoking Relapse Among Individuals Who Switched to e-Cigarettes or Other Tobacco Products: “In this cohort study of a representative sample of US adults, 9.4% of respondents who smoked cigarettes became recent former smokers 1 year later. Switching to any tobacco product including e-cigarettes was associated with an 8.5% increase in relapse to smoking over the next year; this increase in relapse was similar to that seen in individuals who switched to other tobacco products…
Switching to e-cigarettes is not associated with relapse prevention for cigarette smoking in US adults.”[Emphasis added]

Today's News and Commentary

About Covid-19

Renewal of Determination That A Public Health Emergency Exists: “As a result of the continued consequences of the Coronavirus Disease 2019 (COVID-19) pandemic, on this date and after consultation with public health officials as necessary, I, Xavier Becerra, Secretary of Health and Human Services, pursuant to the authority vested in me under section 319 of the Public Health Service Act, do hereby renew, effective October 18, 2021, the January 31, 2020, determination by former Secretary Alex M. Azar II, that he previously renewed on April 21, 2020, July 23, 2020, October 2, 2020, and January 7, 2021, and that I renewed on April 15, 2021 and July 19, 2021, that a public health emergency exists and has existed since January 27, 2020, nationwide.”
The renewal extends the state of emergency for at least another 90 days.

F.D.A. to Allow ‘Mix and Match’ Approach for Covid Booster Shots: “The Food and Drug Administration is planning to allow Americans to receive a different Covid-19 vaccine as a booster from the one they initially received, a move that could reduce the appeal of the Johnson & Johnson vaccine and provide flexibility to doctors and other vaccinators.
The government would not recommend one shot over another, and it might note that using the same vaccine as a booster when possible is preferable, people familiar with the agency’s planning said. But vaccine providers could use their discretion to offer a different brand, a freedom that state health officials have been requesting for weeks.”

Efficacy of interferon beta-1a plus remdesivir compared with remdesivir alone in hospitalised adults with COVID-19: a double-bind, randomised, placebo-controlled, phase 3 trial: “Interferon beta-1a plus remdesivir was not superior to remdesivir alone in hospitalised patients with COVID-19 pneumonia. Patients who required high-flow oxygen at baseline had worse outcomes after treatment with interferon beta-1a compared with those given placebo.” This study highlights the benefits of treatments for Covid-19 under specific clinical conditions.

Pfizer, Moderna will rake in a combined $93 billion next year on COVID-19 vaccine sales: report: “The messenger RNA shot producers are projected to break the bank next year, generating combined sales of $93.2 billion, nearly twice the amount they are expected to rake in this year, says Airfinity. The health data analytics group puts total market sales for COVID-19 vaccines in 2022 at $124 billion, according to data seen by The Financial Times.”

Assessment of Out-of-Pocket Spending for COVID-19 Hospitalizations in the US in 2020: “In this cross-sectional study of 4075 COVID-19 hospitalizations in 2020, 71.2% of privately insured patients and 49.1% of Medicare Advantage patients had cost sharing for any hospitalization-related service, including those billed by clinicians; 4.6% of privately insured and 1.3% of Medicare Advantage had cost sharing for facility services billed by hospitals, with mean out-of-pocket spending of $3840 and $1536, respectively…
The findings suggest that out-of-pocket spending for COVID-19 hospitalizations may be substantial if insurers allow cost-sharing waivers to expire.”

Pfizer vaccine 93% effective at preventing hospitalizations in 12-18 year olds, CDC says: “Pfizer's COVID-19 vaccine was 93 percent effective at preventing hospitalizations from the virus in children ages 12 to 18 in a real-world study conducted by the CDC, the agency said Oct. 19.”

About health insurance

‘An Arm and a Leg’: Hello? We Spend 12 Million Hours a Week on the Phone With Insurers: An interesting podcast with the message in the headline. Dan Weissmann is a great interviewer.

UnitedHealth launches employer virtual primary care service: “UnitedHealthcare is expanding its telehealth offerings for employers with a new virtual primary care service that offers access to doctors with low or no co-pays for routine visits on their phones or via computer…
UnitedHealth is partnering with telehealth provider Amwell, which will provide the platform for virtual care as well as the clinical services through its medical group. The virtual primary care program will initially be available for employers in 11 states including Colorado, Texas and Maryland, as well as Washington, DC.”

Estimated Medicare Spending on Cancer Drug Indications With a Confirmed Lack of Clinical Benefit After US Food and Drug Administration Accelerated Approval: “Between 2017 and 2019, Medicare Parts B and D cumulatively spent at least $569 million on the 10 cancer drug indications with a confirmed lack of OS [overall survival] benefit after AA[accelerated approval]. Approximately $224 million of this spending was for indications that were either voluntarily withdrawn by the manufacturers or recommended by the ODAC for withdrawal. These results suggest that spending on the remaining 4 AA indications may continue to increase unless the FDA revokes these indications.”

AMERICAN CUSTOMER SATISFACTION INDEX:Insurance and Health Care Study 2020-2021: Start with pages 4-6. Note that Hospitals are two points lower than the US Postal Service.

About healthcare IT

Third-party health apps are vulnerable to hacks, report finds: A reminder: “Third-party health apps that pull patient data from electronic health record systems are vulnerable to hacks, according to a new report. The electronic health records themselves, which are housed at health centers and subject to the federal privacy law HIPAA, are well protected. But as soon as a patient gives permission for their data to leave the health record and head toward a third-party app — like programs that track people’s medications, for example — it’s easy for hackers to access. 
Hospitals and health care systems are a major target for hackers, and attacks have only escalated over the past few years. Patient health data is some of the most valuable information to hackers: each record can be worth hundreds of dollars on the dark web, in part because they can’t be changed easily and it’s harder to detect when the data is used fraudulently. Credit card numbers, on the other hand, can easily be changed and are only worth a few dollars.”

Finances Stymie Patient Data Sharing, Interoperability at FQHCs: “Federally qualified health centers (FQHCs) and other safety-net providers face interoperability challenges that limit their patient data sharing capabilities, according to a new whitepaper published by CareAdvisors…
The majority of safety net providers, including community hospitals, FQHCs, and community health clinics, have been excluded from patient data sharingopportunities due to a lack of resources for investment in EHR systems such as Epic and Cerner that interoperate with other providers.”

Man gets 7-year prison sentence for 2014 UPMC database hack: The article highlights the potentially severe penalties for hacking: “A Michigan man was sentenced to seven years in prison for his role in the hacking and theft of data belonging to more than 65,000 UPMC employees, the Justice Department said Oct. 18. 
Justin Sean Johnson, 30, of Detroit, was charged in June 2020 and sentenced Oct. 15, 2021, to 60 months' incarceration for conspiracy to defraud the U.S. and 24 months for aggravated identity theft for hacking into the Pittsburgh-based health system's human resource server databases in 2013 and 2014…”

About healthcare devices

Hearing aids without a prescription or an exam? The FDA takes big step toward making that happen.: “More than four years after Congress ordered the agency to allow over-the-counter hearing aids, it took the first step Tuesday to broaden access to more accessible and affordable devices for millions of patients with mild to moderate hearing loss. The agency’s proposal would create a new category of over-the-counter hearing aids and supersede state-level regulations that require patients to go through physicians or audiologists to get prescriptions and fittings for them.”

About the public’s health

US flu cases up 23 percent from 2020: “The U.S. has seen 23 percent more flu cases this year compared to last year’s influenza season, though flu activity is still below normal pre-pandemic years, according to data collected by the Walgreens Flu Index.
According to the flu index, which includes data through the week ending on Oct. 9, Nevada leads the U.S. in the number of flu cases reported this year, followed by Mississippi and Texas.”

About healthcare providers

Grand Rounds Health and Doctor On Demand Rebrand as Included Health: “-Grand Rounds Health and Doctor On Demand… announced their combined integrated virtual care and navigation company will be called Included Health.”

Today's News and Commentary

About Covid-19

Covid Weekly Tracker Review: From the CDC: “The current 7-day moving average of daily new cases (84,555) decreased 12.5% compared with the previous 7-day moving average (96,666). A total of 44,615,528 COVID-19 cases have been reported as of October 13, 2021.”

CDC data: Unvaccinated 11 times more likely to die from COVID-19 than fully vaccinated: “Unvaccinated people have an 11 times higher risk of dying from COVID-19 than fully vaccinated people, according to new data posted by the Centers for Disease Control and Prevention (CDC). 
The data run through August and are from 16 health departments representing about 30 percent of the U.S. population, the CDC said. 
In addition, the data show that unvaccinated people have a six times higher chance of testing positive for COVID-19 than fully vaccinated people do.”

U.S. Moves Pandemic Data Tracking to CDC, Reversing Trump: “The Biden administration is moving the U.S. government’s largest public-health tracking system back to the Centers for Disease Control and Prevention, undoing a much-criticized move by the Trump administration to shift custody of critical data from the nation’s top epidemiological agency.
According to a document obtained by Bloomberg News, the Department of Health and Human Services on Oct. 1 signed off on a recommendation to move the system, designed to track pandemic data, out of the management of its own Office of the Chief Information Officer and into CDC’s oversight.”

Antibody tests can’t give answers you want about covid-19 immunity.: A reminder: “Both the Centers for Disease Control and Prevention and the Food and Drug Administration advise against using antibody tests to determine one’s level of immunity against covid-19, the disease caused by the coronavirus. So does the Infectious Disease Society of America, which represents infectious-disease specialists.”

‘I hope you die’: how the COVID pandemic unleashed attacks on scientists: “Dozens of researchers tell Nature they have received death threats, or threats of physical or sexual violence.”

WTO member nations again fail to agree on Covid-19 vaccine patent waiver: “The council of the WTO agreement on Trade-Related Aspects of Intellectual Property Rights (Trips) met recently to try to make progress on the issue, but the agency said the council had not reached a consensus. Further talks are also scheduled for October 26.”

About pharma

FDA approves first interchangeable biosimilar for Humira: “The FDA said Oct. 18 it has approved Cyltezo, the first interchangeable biosimilar for AbbVie's best-selling drug Humira. 
Cyltezo, made by Boehringer Ingelheim, is the second interchangeable biosimilar drug approved by the FDA, following the approval of Mylan's Semglee in July. It is the first interchangeable monoclonal antibody approved. “

Lupin Pharmaceuticals Recalls All Irbesartan Tablets Over Potential Impurity: “Lupin Pharmaceuticals is recalling all batches of its irbesartan and irbesartan/hydrochlorothiazide tablets in the U.S. over concerns the blood pressure drugs may contain N-nitrosoirbesartan, a likely carcinogen.”

About the public’s health

Biden administration moves to curtail toxic ‘forever chemicals’: “The Environmental Protection Agency said it will move with urgency to set enforceable drinking water limits on certain polyfluoroalkyl and perfluoroalkyl substances, or PFAS, more commonly known as “forever chemicals,” which do not break down naturally and have turned up in the water supplies of communities around the country.
The agency also will require manufacturers to provide detailed data about entire classes of compounds they produce, and plans to designate some of them as hazardous chemicals under the nation’s Superfund law.”

About medical devices

FDA Designates Osteoarthritis Microspheres a Breakthrough Device: “The microspheres are delivered in a minimally invasive procedure to reduce blood flow to the periarticular tissue of the joints, limiting the inflammatory process.
The microspheres have other applications, such as blocking blood flow to hypervascular tumors, arteriovenous malformations and uterine fibroids.”

About health insurance

Walmart unveils employer market team-up with Transcarent: “Walmart is teaming with Transcarent to make it easier for self-funded employers to access its healthcare services.
This is the first time Walmart has made such an agreement to offer its prices on pharmaceuticals and other healthcare services to employers. The partnership aims to allow employers to leverage the retail giant's size and scale to offer more convenient care and cost-effective health and wellness options.”