Thursday Miscellany

Thursday Miscellany

Photo by Josh Mills on Unsplash

From the Delta variant front, AHIP informs us

Today, the Food and Drug Administration (FDA) Vaccine and Related Biological Products Advisory Committee (VRBPAC) voted to unanimously (19-0) endorse a booster dose for the Moderna COVID-19 vaccine for persons:

  • 65 years of age and older;
  • 18 through 64 years of age at high risk of severe COVID-19; and
  • 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.

The Moderna booster dose is 50 micrograms – half the dosage of each of the first two doses in the series.  Individuals who are immunocompromised will receive the larger dose as was administered for earlier doses, as the third dose is considered part of the original series rather than a booster. * * *

The VRBPAC will convene again tomorrow to discuss recommendations for booster doses of the Johnson & Johnson vaccine and NIH will present data on heterologous use of booster doses following primary series of the three currently authorized or approved vaccines.

The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) will meet to discuss recommending the Moderna and Johnson & Johnson vaccine boosters on October 20-21

Yesterday, the Equal Employment Opportunity Commission updated its COVID 19 vaccine incentive and mandate FAQ guidance for employers. The EEOC enforces the Title VII, the Americans with Disabilities Act and the Genetic Information Non-Discrimination Act among other measures. No surprises, as far as the FEHBlog can tell. Search for 10/13/2021 to find the new FAQs.

In related news, Politico reports that “President Joe Biden is likely to nominate former Food and Drug Administration Commissioner Robert Califf to return to the top role at the sweeping regulatory agencyaccording to four people with knowledge of the situation. * * * Califf previously served as commissioner for nearly a year in Obama’s second administration after an overwhelming vote in his favor. The White House has not finalized its decision, and the people with knowledge cautioned the situation could still change. But nine months into its search for a permanent FDA chief, Califf is now viewed as the leading candidate for the job.

In healthcare business news —

Healthcare Dive tells us that

  • UnitedHealth Group expects its planned $13 billion acquisition of data analytics firm Change Healthcare that’s been held up by DOJ review to close “in the first part of 2022,” COO Dirk McMahon told investors on a Thursday morning call.
  • The news is likely to anger hospital groups, which have raised concerns — some direct to regulators — that the deal could lower health IT competition and give its payer arm UnitedHealthcare an unfair advantage in contract negotiations.
  • The news comes as the diversified healthcare [company] beat Wall Street expectations on both earnings and revenue in the third quarter, with a topline of $72.3 billion, up 11% year over year, due to double-digit percentage growth in both UnitedHealthcare and health services business Optum. Profit was $4.2 billion, up 29% compared to the third quarter last year. As a result, Minnetonka, Minnesota-based UnitedHealth bumped its full-year guidance.

The Wall Street Journal reports that

Walgreens Boots Alliance Inc. will pay $5.2 billion to acquire a controlling stake in primary-care network VillageMD as the pharmacy chain seeks to remodel itself as a healthcare provider.

VillageMD operates more than 200 clinics where it has acquired or hired its own physicians and medical staff. Walgreens said the investment will enable it to open doctors’ offices at 600 or more of its drugstore locations by 2025, and a further 400 by 2027.

The drugstore company already owns a stake in VillageMD after agreeing last summer to pay $1 billion in equity and debt over the three years in exchange for a 30% stake in the Chicago-based startup. Under the deal announced Thursday, Walgreens will hold a 63% stake in VillageMD.

The deal is the first major strategic move under Walgreens Chief Executive Rosalind Brewer, who came to the company from Starbucks in January.

Also Thursday, Walgreens said it would acquire a majority stake in CareCentrix Inc., a Hartford, Conn.-based home health benefits manager. Walgreens said it derives 85% of its revenue from some 35 million customers who have chronic conditions such as diabetes or heart disease.

Finally, STAT News reports that

Five months ago, weight loss company Noom announced $540 million in funding, dwarfing its previous investments. With locked-down users flocking to its app, revenues in 2020 had surged to $400 million, and the company made an ambitious pitch: It would spend the money to expand its behavioral change approach to other conditions, including diabetes, hypertension, and sleep.

Now, Noom is taking its first big step toward becoming a diversified digital health company with Noom Mood, a smartphone wellness app targeted toward people with daily stress and anxiety. Like the company’s weight loss program, Mood — which the company first rolled out as a beta program last year — primarily draws on concepts from cognitive behavioral therapy. “It was kind of a no-brainer,” said Andreas Michaelides, Noom’s chief of psychology. “These concepts are really what we consider to be the gold standard with psychology.”

Midweek update

From the COLA front, FedWeek informs us that

  • A federal retirement COLA of 5.9 percent will be paid in January to those retired under CSRS and 4.9 percent to those retired under FERS who are eligible for COLAs, increases that have been neared in recent decades only twice.
  • The announcement follows completion of the count toward that adjustment with release of the September inflation figure on Wednesday (October 13), which was up 0.4 percent. * * *
  • A 5.9 increase also will be paid on Social Security benefits. That’s primarily of interest to FERS retirees, for whom Social Security is a basic part of the retirement benefit, but also of interest to CSRS Offset retirees who have Social Security coverage as part of their benefit. Also, some “pure” CSRS retirees qualify for Social Security through from military service or earnings covered under that system before, after—and in some cases from outside earnings during—their CSRS working years. In many cases those benefits are reduced by the “windfall elimination provision” however. * * *
  • Congress appears to be on track to accept a raise payout by default of President Biden’s recommendation for a 2.7 percent average raise, with 2.2 percentage points to be paid across the board and the funds for the remainder divided up as locality pay.

From the Delta variant front, MedPage Today offers an interesting article on the efforts of primary care providers to convince their reluctant patients to receive a COVID vaccine.

[Australian social psychologist Matthew] Hornsey [observed] that in a world where the institutional memory of pandemics has been lost, only the perception of vaccine risk remains. With adverse effects making headlines daily, even in mainstream outlets, it’s hard to promote a message of safety.

David M. Oshinsky, PhD, a Pulitzer Prize-winning author and professor of medicine at NYU Grossman School of Medicine in New York City, noted the sense of euphoria with the polio vaccine, dubbed at the time as “the peoples’ vaccine.”

Well put.

Also, the Food and Drug Administration (FDA) staff today released their vaccination advisory committee briefing book on the one dose Johnson & Johnson vaccine. According to the Wall Street Journal’s report

A booster of Johnson & Johnson’s Covid-19 vaccine showed signs of significantly bolstering the immune defenses of study subjects, federal health regulators said Wednesday.  The regulators cautioned, however, that data was limited and that they had to rely on J&J’s own analysis for some of the study findings, rather than conducting their own.

The committee will take up the Modern booster tomorrow and the Johnson & Johnson vaccine as well as the topic of mixing and matching different COVID boosters on Friday.

From the telehealth front, Employee Benefit News reports that

Telehealth providers have found that their platforms are uniquely suited to address gaps in pediatric behavioral healthcare and are expanding their services to adolescents. Brightline, launched just before the pandemic, offers an “on-ramp” to behavioral health services, Allen says. The platform does an intake assessment and then provides education and 30-minute coaching services for parents and their children.

“Kids are actually more resilient using technology than we expected, and now there’s a strong preference for virtual first behavioral healthcare, because of the privacy and the comfort of delivering care in your home,” Allen says. “If Brightline hired every single pediatric therapist in the entire United States, we would still have a national shortage, so we instead use these tools to figure out what’s an appropriate care pathway and measure whether they’re working.”

From the Rx coverage front, STAT News informs us that Pfizer is backing up one of its expensive lung cancer drugs Xalkori with a insurance company backed warranty.

“In reality, this is for Medicare patients,” said Susan Raiola, president of Real Endpoints, an advisory and analytics firm that tracks reimbursement issues. Why? Medicare co-pays are used toward the so-called donut hole, the term used to describe a temporary limit on what Medicare will pay to cover a drug. The co-pays can add up, though, making refunds more desirable. * * *

To what extent warranties may become commonplace remains to be seen. But the concept may find takers among drug makers marketing high-priced treatments that cost $1 million or more, because winning reimbursement is challenging, according to Emad Samad, president of Octaviant Financial, a firm that is promoting the use of warranties in the pharmaceutical industry.

“So far, no one else has done this,” Samad said of the Pfizer program. “But where warranties will really come into play will be with high-cost treatments, such as gene and cell therapies. These companies will have to change commercial paths with these $1 million to $3 million drugs. They need tools – such as even more innovative warranty structures – so that payers can get comfortable with the varied outcomes potentially transformative therapies could have.”

From the medical devices front, Healthcare Dive informs us that the “FDA has awarded the latest crop of breakthrough device designations, granting regulatory privileges to investigational products including liquid biopsy tests for Alzheimer’s disease and bladder cancer. Check out the list.

From the medical research front, the National Institutes of Health announced that “A commonly available oral diuretic pill approved by the U.S. Food and Drug Administration may be a potential candidate for an Alzheimer’s disease treatment for those who are at genetic risk, according to findings published in Nature Aging. The research included analysis showing that those who took bumetanide — a commonly used and potent diuretic(link is external) — had a significantly lower prevalence of Alzheimer’s disease compared to those not taking the drug.” Fingers crossed.

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From the Capitol Hill front, Roll Call reports that “The House [of Representatives] cleared a temporary debt limit bill Tuesday that will buy lawmakers a little more time [at least until December 3] to negotiate a longer-term solution * * * . The House voted 219-206 to adopt a rule for floor debate on unrelated legislation that “deemed” the Senate-passed debt limit bill as having cleared that chamber. That maneuver sent the bill, which would increase the Treasury Department’s borrowing authority by $480 billion to nearly $28.9 trillion, to President Joe Biden’s desk where he’s expected to sign it this week.”

Here are a few COVID vaccination mandate tidbits for your consideration —

  • Fedweek discusses the status of the President’s mandate that federal employees receive the COVID vaccine.
  • CNBC lets us know that Boeing, which holds large defense contracts, is rolling out a COVID vaccination mandate for its 125,000 U.S. employees.
  • The Wall Street Journal reports that

The Labor Department signaled Tuesday evening that it is close to acting on President Biden’s plan to require private-sector workers get Covid-19 vaccinations or be regularly tested, a move that has drawn a mixed reaction from larger and smaller companies.

The proposed mandate, according to an earlier announcement by the Biden administration, would apply to businesses with 100 or more employees. It would be implemented under a federal rule making known as an emergency temporary standard and affect roughly 80 million workers nationwide, according to Biden administration estimates, or more than half the total U.S. workforce.

The Labor Department said its Occupational Safety and Health Administration submitted the initial text of the proposed standard to the White House for approval, signaling its final release could soon follow. The details could change during the White House review.

Also from the Delta variant front, STAT News tells us that “Food and Drug Administration scientists did not take a clear position as to whether the agency should authorize booster doses of the Moderna Covid-19 vaccine in documents released Tuesday. * * * The FDA has not made available its briefing document on the Johnson & Johnson vaccine. * * * [The briefing documents relate to the FDA vaccine advisory committee meetings scheduled for Thursday and Friday this week.] One of the most interesting topics for the meeting comes at the end of day two: the discussion of a National Institutes of Health study that examines what happens when people get a booster dose of a different vaccine than the one they originally received. Allowing such mix-and-match boosterscould make it much simpler to give people the shots in the future. It would also open the Covid-19 vaccine market up to many more players, instead of giving Pfizer and Moderna an effective lock on the market.”

In miscellaneous tidbits

  • The National Institutes of Health yesterday announced that

A commonly available oral diuretic pill approved by the U.S. Food and Drug Administration may be a potential candidate for an Alzheimer’s disease treatment for those who are at genetic risk, according to findings published in Nature Aging. The research included analysis showing that those who took bumetanide — a commonly used and potent diuretic(link is external) — had a significantly lower prevalence of Alzheimer’s disease compared to those not taking the drug. The study, funded by the National Institute on Aging (NIA), part of the National Institutes of Health, advances a precision medicine approach for individuals at greater risk of the disease because of their genetic makeup.

The research team analyzed information in databases of brain tissue samples and FDA-approved drugs, performed mouse and human cell experiments, and explored human population studies to identify bumetanide as a leading drug candidate that may potentially be repurposed to treat Alzheimer’s.

“Though further tests and clinical trials are needed, this research underscores the value of big data-driven tactics combined with more traditional scientific approaches to identify existing FDA-approved drugs as candidates for drug repurposing to treat Alzheimer’s disease,” said NIA Director Richard J. Hodes, M.D.

  • FEHB plans that offer plan brochures in Spanish may be interested to know that AHRQ has translated its medical visit question builder tool for patients into Spanish.
  • In an interesting business move, Best Buy, according to Healthcare Dive, is expanding its home healthcare business.

Best Buy is acquiring United Kingdom-based at-home care platform Current Health for an undisclosed amount, expanding its push into the health industry.

The massive consumer electronics retailer already owns two healthcare companies, and is now snapping up Current, which has a platform combining remote patient monitoring, telehealth and patient engagement. The move comes as an increasing amount of care is delivered in the home, accelerating consumers’ use of health tech.

The acquisition should allow Best Buy to play a bigger role in virtual care delivery, the company said in a blog post Tuesday. Best Buy expects the deal, which will be financed with cash, to close by the end of the fourth quarter of its 2022 fiscal year, per a filing with the U.S. Securities and Exchange Commission.

Monday Roundup

Photo by Sven Read on Unsplash

From the Delta variant front, the New York Times reports that “The federal government is expected to take a significant step this week toward offering booster doses to a much wider range of Americans as advisers to the Food and Drug Administration meet on Thursday and Friday [this week] to discuss recipients of the Johnson & Johnson and Moderna coronavirus vaccines.”

The Times also informs us that

Merck said on Monday that it had submitted an application to the Food and Drug Administration to authorize what would be the first antiviral pill to treat Covid.

Clearance for the drug, molnupiravir, would be a milestone in the fight against the coronavirus, experts said, because a convenient, relatively inexpensive treatment could reach many more high-risk people sick with Covid than the cumbersome antibody treatments currently being used.

The Biden administration is preparing for an authorization that could come within weeks; the pill would likely to be allocated to states, as was the case with the vaccines. States could then distribute the pills how they wish, such as through pharmacies or doctors’ practices, senior administration officials said.

If the pill wins authorization, tens of millions of Americans will most likely be eligible to take it if they get sick with Covid — many more than the supply could cover, at least initially. The federal government has placed an advance order for enough pills for 1.7 million Americans, at a price of about $700 per patient. That is about one-third the price that the government is paying for the monoclonal antibody treatments, which are generally given via intravenous infusion.

Fingers crossed on the pill.

From the hospital transparency front, Fierce Healthcare assesses a New York Times analysis of hospital pricing. Fierce Healthcare finds that cash prices can be lower than prices paid by insurers.

America’s Health Insurance Plans published a statement saying the attempt to look at the data “spotlights a lot of numbers with little context” and “often compares apples and oranges.” 

Because of these complexities, the CMS rule does not help patients “shop for services” as intended, said Delphine O’Rourke, a healthcare attorney and partner at Goodwin Procter. “I, as a consumer, don’t know at the end of the day what I’m going to be responsible for,” she said. 

To O’Rourke, it’s not surprising that at times, a hospital’s cash price is lower for a service. Since people paying cash price are generally a small segment of patients, she explained, and tend to be uninsured or undocumented, hospitals structure cash pay anticipating that it will be “challenging to collect,” O’Rourke said. (Earlier this year, the Wall Street Journal found that many times, patients who pay with cash are actually charged the highest price across hospitals.) 

Be sure to listen to this week’s Econtalk episode during which Russ Roberts interviews Sam Quinones who wrote the FEHBlog’s favorite book of 2017, Dreamland. (While the book was published in 2015, the FEHBlog discovered it from a 2017 Econtalk episode.) This week Mr. Quinones discusses the tremendous impact of fentanyl on growing our opioid epidemic. He explains that dealers learned to lace fentanyl into non-addictive drugs like cocaine and meth thereby creating daily customers for them. Because Econtalk episodes last over an hour, you can find a transcript on the website. The FEHBlog has pre-ordered Mr. Quinones new book, the “Least of Us True Tales of America and Hope in the Time of Fentanyl and Meth,” which is available on Amazon for the Kindle at around nine dollars.

Thursday Miscellany

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From Capitol Hill, Roll Call reports that

The Senate passed a temporary debt limit increase along party lines Thursday evening, a move that would give the Treasury Department at least a couple of months before it once again bumps up against its legal borrowing cap.

The 50-48 vote sent the bill to the House, where that chamber will need to clear the measure before it heads to President Joe Biden. That vote, likely next week, could be tricky given GOP opposition to the short-term patch and Democrats in that chamber barely backing a longer suspension of the debt limit late last month.

Karine Jean-Pierre, the White House’s principal deputy press secretary, said Biden “looks forward to signing” the debt limit measure after it clears.

The Senate amended the House bill, which passed 219-212, replacing a longer debt ceiling suspension with a $480 billion increase in Treasury’s borrowing cap designed to last into early December, though it may go a little longer.

The current continuing appropriations resolution is set to expire relatively contemporaneously on December 3, 2021.

From the Federal Benefits Open Season front, federal benefits consultant Tammy Flanagan has posted her first GovExec column on this year’s Open Season while GEHA, the second largest plan in the FEHB, has posted information on its 2022 benefits.

From the Delta variant front, Healthcare Dive informs us that

Pfizer and BioNTech have officially asked U.S. regulators for emergency clearance of their coronavirus vaccine in children between 5 and 11 years old, making the developers the first to seek authorization for younger kids.

Thursday’s announcement, which Pfizer made on Twitter, comes nine days after the companies said they had started submitting data to the Food and Drug Administration in support of their application, which, if authorized, could make more than 28 million children in the U.S. eligible for vaccination.

The FDA has already scheduled an Oct. 26 advisory panel to discuss the vaccine’s potential authorization in children, more and more of whom have been infected and hospitalized as the delta variant spread and the school year began. Clearance is reportedly expected in November, though the evaluation could be complicated by turnover within the agency’s vaccine review office.

From the healthcare business front —

Healthcare Dive tells us that

Total revenue of hospital M&A so far this year dipped only slightly from last year despite the number of deals being nearly cut in half, according to a Wednesday report from Kaufman Hall.

The average seller size of $659 million was well above year-to-date average going back to 2015, the earliest year featured in the report. This year’s third quarter included the Intermountain Health merger with SCL Health to create an $11 billion system and HCA’s buy of five Steward Health hospitals in Utah.

Hospitals are increasing looking outside traditional care delivery methods to diversify business models by pursuing stakes in home health, virtual care and post-acute services. They are also identifying strategic partnership with payers, physicians groups and other adjacent sectors, Kaufman Hall said.

United Healthcare’s subsidiary Optum announced a collaboration with SSM Health, a Catholic health system in the Midwest.

Together, the organizations will work to improve the overall well-being of individuals and communities – while addressing the complex social and economic factors affecting each person’s health.

SSM Health and Optum will partner across certain functions – including inpatient care management, digital transformation and revenue cycle management – to improve health outcomes and patients’ health care experiences. The organizations also will collaborate to redefine the consumer health care journey through the design and development of a seamless digital experience to simplify patient access to the care and services they need.

“Creating a new ecosystem of care requires bringing together the best and the brightest to collaborate for the common good,” said Laura S. Kaiser, FACHE, president and chief executive officer, SSM Health. “The commitment of UnitedHealth Group and Optum to improving health care experiences and outcomes for everyone aligns well with SSM Health’s Mission to ensure all people have access to high-quality, compassionate and affordable care. We are excited to partner with them to achieve our vision of transforming health care in America – and address the health equity gap for the most vulnerable in society.”

To help advance health equity, UnitedHealth Group and SSM Health will jointly invest in vital community health programs to ensure the disadvantaged and vulnerable have equal access to quality health care services. These efforts will focus on closing the health equity gap and critical health priorities in the communities SSM Health serves throughout the Midwest.

Medcity News reports that

Primary and urgent care provider Carbon Health is expanding its service offerings with a new acquisition.

The San Francisco-based company has bought Alertive Healthcare, a remote patient monitoring provider, for an undisclosed sum. Alertive Healthcare provides a suite of RPM tools across a range of specialties, including primary care, cardiology, neurology and nephrology. * * *

Carbon Health launched in 2015 and has raised upwards of $522 million in funding, according to Crunchbase. Its goal is to become the “Starbucks of healthcare.”

As of August, Carbon Health operated 83 clinics across 12 states following its acquisition of Tucson, Arizona-based Southern Arizona Urgent Care and Sacramento, California-based Med7 Urgent Care.

From the telehealth front, Healthcare Dive reports that

Teladoc Health on Wednesday announced it is making its virtual primary care pilot broadly available to commercial health plans, employers and other benefits sponsors nationwide.

The Primary360 service, which the New York-based telemedicine giant has been piloting for the past few years, is currently being used by several large companies, and will be available through CVS Health-owned payer Aetna early next year, Teladoc said in a release.

The vendor hopes Primary360 will serve as an access point to the primary care system while enticing patients to its other services like specialty care and mental health to boost business.

From the miscellany department, Healthcare Dive interviewed the CEO of Morgan Health.

The mission of J.P. Morgan’s new healthcare venture is to innovate employer-sponsored healthcare, not just for the investment bank’s massive employee base but eventually for all 150 million Americans receiving coverage through their job. But it’s a lofty goal for the small business unit, called Morgan Health, launched late May, and there are many skeptics of efforts from major employers looking to disrupt the deep-rooted and complex healthcare industry.

Check it out.

Midweek Update

From Capitol Hill, the Wall Street Journal reports that

Senate Democrats were poised to accept a GOP proposal to defer the showdown over the debt ceiling until later this year, lawmakers said, as administration officials and corporate executives issued dire warnings about the dangers of a possible government default.

The proposed agreement would extend the debt ceiling into December, provided that Democrats affix a dollar amount to the debt level. A deal could pave the way for a procedural vote in the Senate soon, to be followed by final passage sometime later this week. The House will still have to pass the legislation, which is expected to be signed into law by President Biden.

OPM Director Kiran Ahuja was interviewed today for a Washington Post Live online event. Ms. Ahuja principally discussed implementing the COVID vaccine mandate for the federal workforce and implementing the President’s June 2021 executive order on enhancing diversity, equity and inclusion in the federal workforce.

From the Delta variant front, David Leonhardt in the New York Times posted another column on the need for more rapid COVID tests in our country.

If you wake up with a runny nose or scratchy throat, you should be able to grab a Covid-19 test from your bathroom shelf and find out the result within minutes. The tests exist. They are known as antigen tests and are widely available not only in Britain but also France, Germany and some other places. Rapid tests can identify roughly 98 percent of infectious Covid cases and have helped reduce the virus’s spread in Europe.

In the U.S., by contrast, rapid tests are hard to find, because the Food and Drug Administration has been slow to approve them. F.D.A. officials have defended their reluctance by saying that they need to make sure the tests work — which they certainly do. But many outside scientists have criticized the agency for blocking even those antigen tests with a demonstrated record of success in other countries. * * *

[At long last,] The F.D.A. announced Monday that it would allow the sale of an antigen test known as Flowflex. The test has been available in Europe but not here, even though the company that makes it — Acon Laboratories — is based in San Diego.

The decision suggests that the F.D.A. has become willing to approve other rapid tests too, Alex Tabarrok, an economist at George Mason University and an advocate of expanded testing, told me. Separately, the Biden administration plans to announce an expansion of rapid testing today, a White House official told me last night. It will be a $1 billion government purchase of tests, meant to accelerate their production, on top of other money the administration has already dedicated to rapid tests.

[I]t is not too late for rapid tests to improve day-to-day life. The Biden administration finally seems to be taking significant steps in that direction.

From the health equity front, Becker’s Payer Issues tells us that

United Health Foundation’s “America’s Health Rankings 2021 Health of Women and Children Report” report cites an increase in maternal mortality and a decrease in women and child physical activity.

The annual report from the UnitedHealth Group’s philanthropic arm, shared in an Oct. 6 announcement, called out a range of physical and behavioral health trends among women and children.

Among key findings is a 16 percent spike in average maternal mortality, shifting from 17.4 deaths per 100,000 births to 20.1 deaths. Florida was the state with the highest jump, up 70 percent to 26.8 deaths per 100,000 births.

Physical activity in children and women is also down, with only 20.6 percent of children and 21.5 percent of women meeting federal physical activity standards, according to the report. 

The report’s executive summary also pointed to rising mental health burdens on youths, including a 1.6 percentage point increase in childhood anxiety. Teen suicide is up 26 percent over 2014-2016 numbers to 11.2 deaths per 100,000 adolescents. 

Women also experienced 14 percent increased mental distress over 2016-2017 numbers

Health Affairs digs deeper into the maternal mortality issue and finds using data from fourteen state Maternal Mortality Review Committees (MMRCs) over the period 2008–17 that

Among 421 pregnancy-related deaths with an MMRC-determined underlying cause of death, 11 percent were due to mental health conditions. Pregnancy-related mental health deaths were more likely than deaths from other causes to be determined by an MMRC to be preventable (100 percent versus 64 percent), to occur among non-Hispanic White people (86 percent versus 45 percent), and to occur 43–365 days postpartum (63 percent versus 18 percent). Sixty-three percent of pregnancy-related mental health deaths were by suicide. Nearly three-quarters of people with a pregnancy-related mental health cause of death had a history of depression, and more than two-thirds had past or current substance use. MMRC recommendations can be used to prioritize interventions and can inform strategies to enable screening, care coordination, and continuation of care throughout pregnancy and the year postpartum.

From the Rx front, MedPage Today reports that

A national antibiotic stewardship program at ambulatory care centers was associated with reduced antibiotic prescribing during the pandemic, both overall and for acute respiratory infection (ARI) cases, researchers found.

In an analysis involving nearly 300 practices who took part in the Agency for Healthcare Research and Quality’s (AHRQ) program for improving antibiotic use, there were nine fewer antibiotic prescriptions for every 100 visits by the end of the intervention (95% CI -10 to -8), as well as 15 fewer prescriptions for every 100 ARI-related visits (95% CI -17 to -12), reported Sara Keller, MD, MPH, MSPH, of Johns Hopkins University in Baltimore. * * *

AHRQ’s Safety Program for Improving Antibiotic Use is a national program that involves presentations, webinars, patient handouts, and other educational tools (including the Four Moments of Antibiotic Decision Making tool) and emphasizes three key areas for clinicians: developing and improving antibiotic stewardship; learning strategies for discussing antibiotic prescribing with colleagues, patients, and their families; and best practices for diagnosing and managing common infectious syndromes, as well as allergies to antibiotic.

Fierce Healthcare informs us about a recently established prescription drug manager “Prescryptive Health, a blockchain-powered prescription data platform.”

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

From the Delta variant front

  • The New York Time reports that “Johnson & Johnson on Tuesday morning asked federal regulators to authorize a booster shot for adults, becoming the third coronavirus vaccine manufacturer to do so.”
  • Fierce Healthcare tells us that

AstraZeneca has taken another step toward bringing its COVID-19 antibody cocktail to market, filing for emergency use authorization of the long-acting candidate in coronavirus prophylaxis in the U.S. 

Last month, AstraZeneca delivered evidence that the candidate prevents COVID-19 in people who are unlikely to respond well to vaccines, bouncing back from an earlier failure to report a 77% reduction in the risk of symptomatic coronavirus infection. With all three cases of severe COVID-19 happening in the placebo cohort, AstraZeneca emerged from the study with evidence that it can protect some of the most vulnerable people from the coronavirus.

“Vulnerable populations such as the immunocompromised often aren’t able to mount a protective response following vaccination and continue to be at risk of developing COVID-19. With this first global regulatory filing, we are one step closer to providing an additional option to help protect against COVID-19 alongside vaccines,” Mene Pangalos, executive vice president for biopharmaceuticals R&D at AstraZeneca, said in a statement. 

In his final National Institutes of Health Director’s blog today. Dr. Francis Collins optimistically supports his opinion that most COVID vaccine hesitant people are willing to change their minds. “Over the course of this pandemic, hesitancy has decreased, and many who initially said no are now getting their shots. Many others who remain unvaccinated lean toward making an appointment. The findings come from Aaron Siegler and colleagues, Emory University, Atlanta.”

Dr. Collins today submitted his resignation from his position as NIH Director following over 12 years in that role. His statement reads in part “It has been an incredible privilege to lead this great agency for more than a decade,” said Dr. Collins. “I love this agency and its people so deeply that the decision to step down was a difficult one, done in close counsel with my wife, Diane Baker, and my family. I am proud of all we’ve accomplished. I fundamentally believe, however, that no single person should serve in the position too long, and that it’s time to bring in a new scientist to lead the NIH into the future. I’m most grateful and proud of the NIH staff and the scientific community, whose extraordinary commitment to lifesaving research delivers hope to the American people and the world every day.” Good luck, Dr. Collins, who will continue working in his genetics laboratory.

From the COVID vaccine mandate front, the Safer Federal Workforce Taskforce released more FAQs on the vaccine mandate for federal employees yesterday. Federal News Network summarizes those FAQs here:

Employees have a few more details about what they should expect if they’re planning to declare a medical or religious exception to the Biden administration’s recent federal vaccine mandate.

Employees who have previously had COVID-19 must receive the vaccine, the Safer Federal Workforce Task Force clarified Monday night in another round of frequently asked questions. The task force had previously made such a statement in guidance to contractors, not federal employees.

The Biden administration didn’t detail exactly what kinds of medical or religious reasons might grant an employee an exception to the federal vaccine mandate, but it did offer more hints about what employees might expect if they pursue that route.

More significantly in the FEHBlog’s view, Federal News Network reports that the Defense Department has “issued its guidance for civilian employees on Monday, giving workers [until November 22] to get inoculated.” In order to achieve this goal an employee must have received the Johnson & Johnson one dose vaccine or both doses of the Pfizer or Moderna by November 8 because the full vaccination status accrues two weeks are being fully vaccinated.

From the mergers and acquisitions front, Becker’s Hospital Review tells us that “More than three years after signing a letter of intent to merge [and overcoming regulatory challenges], Jefferson Health and Einstein Healthcare Network have finalized the deal. The combination of the Philadelphia-based organizations brings together two academic medical centers and creates an integrated 18-hospital system with more than 50 outpatient and urgent care locations.”

From the tidbits department:

Allowed in-network charges for fixed-wing air ambulances rose 76% between 2017 and 2020, and now top $15,000, a new study by Fair Health found. The average charge rose 27.6% during the same time period, to more than $24,500 from little more than $19,200. For helicopter transports, the average allowed charge rose 60.8%, from just over $11,600 to more than $18,600.

Meanwhile, the average Medicare reimbursement rose much less dramatically between 2017 and last year, and represents just a fraction of what commercial insurers are charged for air ambulance transports.

Demand may be part of the equation. Fair concluded that air ambulance claims rose 30% between 2016 and 2020. The leading reasons for such transports are digestive issues, heart attacks and bone breaks or fractures. The states with the largest volumes of fixed-wing air transports are rural: Alaska, Wyoming, South Dakota, Montana and New Mexico. For helicopters, it’s Idaho, South Dakota, New Mexico, West Virginia and Wyoming.

  • Health Payer Intelligences delved into the American Medical Association’s annual report on health insurer competition. Kaiser Permanente joined UnitedHealthcare, Anthem, Aetna, and Cigna in the top five.
  • Health Payer Intelligence also tells us that

A new study finds that while telehealth has surged during the pandemic, providers haven’t solved many of the issues that kept adoption low prior to COVID-19.

J.D. Power’s 2021 US Telehealth Satisfaction Survey, released this week, saw a surge in telehealth use from 7 percent in 2019 and 9 percent in 2020 to 36 percent in 2021, reflecting the shift to virtual care as the nation grappled with COVID-19. But the consumer advisory company’s third annual survey also saw a decrease in patient satisfaction, driven by complains over limited services (24 percent), lack of awareness on costs, confusing technology requirements and lack of information about care providers (all at 15 percent).

The more things change, etc.

It’s one of the biggest market failures in modern medicine. The lack of a widely shared data language is effectively blocking adoption of innumerable software applications designed to make health care cheaper, more effective, and personal.

On Tuesday, three large health systems formed a new nonprofit company to fill that gap. The venture, dubbed Graphite Health, is seeking to build an App-Store-like marketplace where digital health entrepreneurs can sell their software tools, and hospitals and consumers can more easily buy and implement them.

Its founders, including Intermountain Healthcare of Utah, previously launched CivicaRX, another hospital-led nonprofit built to create a cheaper, more reliable supply of generic medicines. If it gains the same level of uptake, Graphite could essentially eliminate the long and costly process of vetting and customizing software that hospitals use to do everything from selecting the best treatments for patients to managing their beds and operating rooms. It will also offer a range of apps for patients.

Monday Roundup

Photo by Sven Read on Unsplash

From the COVID variant front, David Leonhardt writes in the New York Times as follows:

Covid-19 is once again in retreat.

The reasons remain somewhat unclear, and there is no guarantee that the decline in caseloads will continue. But the turnaround is now large enough — and been going on long enough — to deserve attention.

These declines are consistent with a pattern that regular readers of this newsletter will recognize: Covid’s mysterious two-month cycle. Since the Covid virus began spreading in late 2019, cases have often surged for about two months — sometimes because of a variant, like Delta — and then declined for about two months. * * *

The recent declines, for example, have occurred even as millions of American children have again crowded into school buildings. * * *

I need to emphasize that these declines may not persist. Covid’s two-month cycle is not some kind of iron law of science. * * *

Eventually, immunity will become widespread enough that another wave as large and damaging as the Delta wave will not be possible. “Barring something unexpected,” Dr. Scott Gottlieb, a former F.D.A. commissioner and the author of “Uncontrolled Spread,” a new book on Covid, told me, “I’m of the opinion that this is the last major wave of infection.”

The New York Times reports that

Johnson & Johnson is planning to ask federal regulators early this week to authorize a booster shot of its coronavirus vaccine, according to officials familiar with the company’s plans. The firm is the last of the three federally authorized vaccine providers to call for extra injections, amid mounting evidence that at least the elderly and other high-risk groups need more protection.

NBC Boston discusses where the regulators stand in terms of approving a Moderna booster. Moderna submitted its emergency use application on September 1. “Adding to the complexity of further decisions on booster shots, Moderna wants its third dose to be half of the original shots.”

The Food and Drug Administration announced

[issuing] an emergency use authorization (EUA) for the ACON Laboratories Flowflex COVID-19 Home Test, an over-the-counter (OTC) COVID-19 antigen test, which adds to the growing list of tests that can be used at home without a prescription. This action highlights our continued commitment to increasing the availability of appropriately accurate and reliable OTC tests to meet public health needs and increase access to testing for consumers.

Today’s authorization for the ACON Laboratories Flowflex COVID-19 Home Test should significantly increase the availability of rapid, at-home tests and is expected to double rapid at-home testing capacity in the U.S. over the next several weeks. By years end, the manufacturer plans to produce more than 100 million tests per month, and this number will rise to 200 million per month by February 2022.

The manufacturer’s press release adds that

The Flowflex COVID-19 Antigen Home Test is a simple nasal swab test which will soon be available for purchase without a prescription in major retail stores and online. It may be used for self-testing by individuals aged 14 years and older, or with adult-collected nasal swabs from children as young as 2 years old.

In contrast to other home tests which require testing twice within a two-to-three-day period (a process known as serial screening), the Flowflex COVID-19 Antigen Home Test has been authorized for use as a single test by individuals with or without symptoms. This will allow for the distribution of more affordable single-test packaging, resulting in greater access to home testing.

Flowflex COVID-19 tests are already available in many countries outside the U.S., including widespread distribution in the UK through the National Health Service (NHS). The international popularity of this test has led ACON to greatly expand global production capacity at multiple manufacturing sites. This emergency use authorization will now allow ACON to quickly respond to the unmet demand for simple and inexpensive home diagnostics as a critical tool in the fight against COVID-19.

STAT News discusses the pricing considerations for Merck’s pill under development to treat COVID at its symptomatic onset. The article notes

Last June, the U.S. government signed a $1.2 billion deal with Merck for 1.7 million doses, which works out to a $712 unit cost for a five-day treatment course, according to the contract. This assumes the U.S. Food and Drug Administration will authorize emergency use of the pill. Separately, the company has indicated there are plans to produce 10 million doses by the end of this year.

This action suggests to the FEHBlog that Merck can charge a substantially lower price for subsequently manufactured pills.

In today’s column David Leonhardt reminds us that COVID has been a national tragedy, which is unquestionably true in the FEHBlog’s opinion. In that regard, Kaiser Health News explains how COVID deaths have struck rural, black, Hispanic, and Native Americans harder than others which also happens to be the pattern of opioid pandemic deaths as the FEHBlog recalls.

From the COVID regulatory front, the federal departments that regulate the Affordable Care Act and related laws issued ACA FAQ 50. AHIP helpfully explains

The first two FAQs address the recent ACIP and CDC announcements regarding booster doses. The FAQ is intended to notify plans and issuers that the December 12, 2020 ACIP recommendation is the applicable recommendation for purposes of the definition of qualifying coronavirus preventive services under section 3203 of the CARES Act and its implementing regulations.

Plans must cover COVID-19 vaccines and their administration, without cost sharing, immediately once the particular vaccine becomes authorized or approved under an Emergency Use Authorization (EUA) or approved under a Biologics License Application (BLA). This coverage must be provided consistent with the scope of the EUA or BLA for the particular vaccine, including any EUA or BLA amendment, such as to allow for the administration of an additional dose to certain individuals, administration of booster doses, or the expansion of the age demographic for whom the vaccine is authorized or approved.

The prior Q8 in FAQs Part 44 is superseded to the extent it provides that the coverage requirement effective date is related to the vaccine-specific recommendations of ACIP.

In response to stakeholder questions around COVID-19 vaccine incentives and surcharges, the Departments released three FAQs:

Premium discounts for COVID-19 vaccinations are permitted if they comply with applicable wellness program regulations including the requirement to provide a reasonable alternative standard to qualify. The vaccine incentive program must not exceed 30 percent of the total cost of employee-only coverage and must give individuals eligible for the program the opportunity to qualify for the reward under the program at least once per year.

Plans and issuers may not discriminate in eligibility for benefits or coverage based on whether or not an individual obtains a COVID-19 vaccination.

Wellness incentives that relate to the receipt of COVID-19 vaccinations are treated as not earned for purposes of determining whether employer-sponsored health coverage is affordable. However, vaccine surcharges would not be disregarded in assessing affordability.

The FEHBlog had called attention to the 15 day deadline for plans to convert their systems to accomodate the new vaccine. The regulators have removed that grace period which likely reflects COVID reality.

Also, Becker’s Hospital Review informs us that “To clear up a lot of misinformation surrounding COVID-19 vaccines and HIPAA, HHS published guidelines Sept. 30 for employees and employers to better understand the privacy rule.”

Weekend Update

Thanks to ACK15 for sharing their work on Unsplash.

This coming week, the U.S. House of Representatives will engage in Committee business and the Senate will engage in both Committee business and the Senate will engage in Committee business and floor voting. Roll Call explains that “President Joe Biden told House Democrats on Friday to hold off on his bipartisan infrastructure bill until they reach agreement on a scaled-back partisan tax and spending package funding the rest of his economic agenda.”

The U.S. Supreme Court opens its October 2021 term tomorrow. Two Affordable Care Act Section 1557 (individual non-discrimination law) cases will be argued this calendar quarter.

On the Delta variant front, the Wall Street Journal reports that

The cost of similar Covid-19 treatments can vary by tens of thousands of dollars a patient, even within the same hospital, according to a Wall Street Journal analysis of pricing data that indicates pandemic care hasn’t escaped the complex economics of the U.S. health system.

One kind of patient, with a type of severe respiratory condition that is common among those admitted with Covid-19, is an example of the wide range. The rates for these patients usually spanned from less than $11,000 to more than $43,000, the analysis found, but some prices could be far higher, depending on the severity of the case.

Federal News Network informs us that

The Office of Personnel Management on Friday offered up more details on how agencies might approach disciplinary action against employees who fail to comply with the Biden administration’s recent federal vaccine mandate.

Because employees aren’t considered fully vaccinated until two weeks after receiving a single-shot series or the second dose of a two-shot series, they must get the vaccine by Nov. 8 to comply with the federal mandate.

Therefore, agencies can begin the disciplinary process for employees who are unvaccinated by Nov. 8 on the following day, Nov. 9, OPM Director Kiran Ahuja said Friday in a new memo.

On the No Surprises Act front, Prof. Katie Keith and her colleagues delves into the details of the second interim final rule on the NSA which concerns the independent dispute resolution process.

On the newly opened Federal Benefits Open Season front, the FEHBlog notes that Blue Cross FEP and Kaiser Permanente have posted information about 2022 benefits on their respective websites. Here’s a belated link to OPM’s announcement of 2022 premiums from last Thursday.

On a related note Healthcare Dive informs us that

Average Medicare Advantage premium rates are dropping 10% to $19 a month next year as nearly 30 million people are expected to be enrolled in the program, an increase of about 2.6 million from this year, CMS said in a Thursday press release.

Cigna and UnitedHealthcare are expanding their MA footprints. Cigna is going into three new states and increasing its geographic coverage by 30%. UnitedHealthcare is entering 276 new counties, giving it access to 94% of Medicare members.

Analysts at Cowen said in a note Friday that after reviewing benefits for the three largest plans from top insurers, it saw stability to modest improvements. That indicates conservative bids among the uncertainty of the COVID-19 pandemic.

Open enrollment for Medicare runs from Oct. 15 to Dec. 7.

Friday Stats and More

Using the CDC’s COVID Data Tracker and Wednesday as the last day of the week, here is the FEHBlog’s latest weekly chart of weekly COVID cases for 2021 through the 39th week (September 29, 2021):

Here is a link to the CDC’s weekly new hospitalization chart which also is trending down:

Here is the FEHBlog’s latest weekly chart of new COVID deaths this year:

Medscape notes that “COVID-19 deaths are beginning to plateau in the US, adding another promising sign that the latest coronavirus surge has peaked. The 7-day average of daily deaths has hovered around 2000 for more than a week and dropped below 1900 on Thursday. The trend follows a 2-month climb in deaths as the Delta variant hit unvaccinated populations, particularly in Arkansas, Florida, and Louisiana. * * * COVID-19 cases began to level off nationally in early September, and hospitalizations and deaths have followed a similar trend several weeks later.”

Here is the FEHBlog’s latest weekly chart of COVID vaccinations distributed and administered in 2021:

The CDC reports that as of today 65% of the eligible U.S population (over age 12) and 84% of the U.S population over age 65 is fully vaccinated. The CDC COVID Data tracker now is displaying booster administration. For example, 6% of the fully vaccinated population over age 65 has received a booster.

Health Leaders Media reports on stakeholder reaction to the No Surprises Act interim final rule on the independent dispute resolution process. AHIP’s President Matt Eyles remarked that the final rule

“signals a strong commitment to consumer affordability and lower healthcare spending through an independent dispute resolution process that should encourage more providers to join health plan networks.”

“We are particularly encouraged to see the rules conform to the intent of the No Surprises Act and direct that arbitration awards must begin with a presumption that the appropriate out-of-network reimbursement is the qualified payment amount,” Eyles said.

“This is the right approach to encourage hospitals, health care providers, and health insurance providers to work together and negotiate in good faith. It will also ensure that arbitration does not result in unnecessary premium increases for businesses and hardworking American families.”

The FEHBlog’s take is that the interim final rule protects consumers while controlling the cost of care. After all, the surprise was not receiving out of network care; rather the suprise was the eye popping bill.