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.

Friday Stats and More

From the Centers for Disease Control’s COVID Data Tracker website, the FEHBlog’s weekly chart of new COVID cases for 2021 (using Wednesday as the last day of the week) is trending down:

The CDC’s chart of weekly chart of new hospital admissions for COVID is also trending down.

The FEHBlog’s weekly chart of new COVID deaths, a lagging indicator, also is beginning to trend down.

Meanwhile COVID vaccinations are up according to the FEHBlog’s chart (also based on CDC statistics)

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The number of COVID vaccines administered in the United States topped 400 million today. Medscape adds that

The number of Americans receiving booster shots is now outpacing those receiving their first or second initial vaccine doses.

The jump in booster shots during the past week has led to a modest increase in COVID-19 vaccinations in October, NBC News reported.

From Sept. 30 to Oct. 6, about 6.7 million total shots were administered, according to CDC data. Among those, about 2.7 million were booster shots, 2 million were second doses, and 2 million were first doses.

The FEHBlog got his Pfizer booster at a local CVS pharmacy last evening.

Here’s a link to the CDC’s Weekly Interpretative Report of COVID statistics.

In other Delta variant news

  • Medscape explains why the COVID Mu variant fizzled.
  • Nature explains why no one was awarded a Nobel prize for the mRNA COVID vaccines this year.

If the vaccines are awarded a Nobel prize, the committee will need to make some difficult decisions about whom to recognize and for what, say scientists. “I’m not surprised they held their fire,” says David Naylor, a physician-scientist at the University of Toronto, Canada. He expects the committee to look past the academic and corporate teams that developed the vaccines, and instead focus on more foundational work, such as that underlying mRNA vaccines. But even there, it’s not clear-cut who the recipients ought to be. 

“I think the mRNA vaccines are obvious candidates,” agrees Arturo Casadevall, a microbiologist at John Hopkins Bloomberg School of Public Health in Baltimore, Maryland, who notes that the vaccines’ development has deep roots in several disciplines. “I can imagine the committee taking its time to sort out which contributions to recognize since many fields contributed to their deployment.”

Working all this out takes time, Hansson says. “We want to give credit to the right people. And for the right discovery,” he says. “So stay tuned.”

  • Govexec offers an update on the VA’s COVID vaccine mandate for its employees.

Friday marked the deadline for the vast majority of Veterans Affairs Department employees to complete their COVID-19 vaccination, though more than 45,000 have yet to demonstrate that they have done so. 

Those employees may eventually face disciplinary action, including being fired, but VA is giving them 10 more days to submit the requisite documentation or request an exemption. The 380,000 VA employees working in or near the health care field faced a deadline of Oct. 8 to receive their vaccines, about six weeks earlier than the rest of the federal workforce, due to the department issuing its own mandate independently of the one put in place by President Biden. 

About 88% of the impacted workforce has so far received a shot, according to data VA has collected. 

From the Federal Benefits Open Season front, OPM today issued its annual Significant FEHB Plan Changes for 2022 benefit administration letter together with a list of those changes and a Fast Facts sheet explaining what to do if your FEHB plan is no longer participating in your locale (or anywhere) for 2022.

The Federal Times interviews retired OPM official Reg Jones about conducting a self-assessment in preparation for the Federal Benefits Open Season.

Thursday Miscellany

Photo by Juliane Liebermann on Unsplash

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.

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.”

Second Interim Final Rule on NSA Implementation Released / Gov’t Shutdown Avoided

The White House

Today, the Departments of Health and Human Services, Labor, and Health and Human Services, and OPM issued the second interim final rule on No Surprises Act (“NSA”) implementation. This rule concerns the independent dispute resolution (“IDR”) process. The process is intended to resolve disputes that arise when an out-of-network provider is dissatisfied with the qualifying payment amount (“QPA”) from the health plan pursuant to the NSA.

The IDR process timeline is as follows:

Independent Dispute Resolution ActionTimeline
Initiate 30-business-day open negotiation period30 business days, starting on the day of initial payment or notice of denial of payment
Initiate independent dispute resolution process following failed open negotiation4 business days, starting the business day after the open negotiation period ends
Mutual agreement on certified independent dispute resolution entity selection3 business days after the independent dispute resolution initiation date
Departments select certified independent dispute resolution entity in the case of no conflict-free selection by parties6 business days after the independent dispute resolution initiation date
Submit payment offers and additional information to certified independent dispute resolution entity10 business days after the date of certified independent dispute resolution entity selection 
Payment determination made30 business days after the date of certified independent dispute resolution entity selection
Payment submitted to the applicable party30 business days after the payment determination

The NSA IDR process uses the so-called baseball arbitration approach under which the decision maker selects one of the parties proposals rather than craft an independent approach as judges do. The requirements description accompanying the final rule explains

When making a payment determination, certified independent dispute resolution entities must begin with the presumption that the QPA is the appropriate OON amount. If a party submits additional information that is allowed under the statute, then the certified independent dispute resolution entity must consider this information if it is credible. For the independent dispute resolution entity to deviate from the offer closest to the QPA, any information submitted must clearly demonstrate that the value of the item or service is materially different from the QPA. Without this additional information, the certified independent dispute resolution entity must select the offer closest to the QPA.

Basically this instructs the health plan to make a proposal close to, if not equal to, the QPA. Then the burden of proof for a higher amount is necessarily placed on the provider. The FEHBlog’s hunch is supported by the following American Hospital Association (“AHA”) statement from the provider side:

AHA Executive Vice President Stacey Hughes said, “The No Surprises Act was an important step forward in protecting patients from surprise medical bills. Hospitals and health systems strongly support these protections and the balanced approach Congress chose to resolve disputes. Disappointingly, the Administration’s rule has moved away from Congressional intent and brought new life to harmful proposals that Congress deliberately rejected. Today’s rule is a windfall for insurers. The rule unfairly favors insurers to the detriment of hospitals and physicians who actually care for patients. These consumer protections need to be implemented in the right way, and this misses the mark.”

AHA staff are reviewing the rule. Watch for a Special Bulletin tomorrow with additional details.

On the bright side for providers, it appears that the IDR process allows the health plan no opportunity to make a low ball proposal to the decision maker. However, it’s the FEHBlog’s view that the devil remains in the details of this lengthy rule and no one should underestimate the ingenuity of lawyers on either side in these novel legal situations. Finally, the apparently simple approach that the regulators took will facilitate implementing the principal feature of the No Surprises Act on January 1, 2022.

From Capitol Hill, Roll Call reports that

President Joe Biden signed a stopgap funding measure Thursday with hours to spare before federal agencies would otherwise have to start shutting down.

The continuing resolution gives lawmakers and the White House nine more weeks to reach agreement on spending levels and negotiate a dozen fiscal 2022 appropriations bills. * * *

The stopgap bill extends federal agencies’ current spending rates, with some exceptions known as “anomalies,” through Dec. 3, as well as certain expiring program authorizations like the National Flood Insurance Program’s ability to sell new policies and renew existing ones. 

The measure provides $28.6 billion to address natural disasters like Hurricane Ida which slammed into the Gulf Coast earlier this month, and $6.3 billion to provide resettlement assistance for Afghan refugees fleeing the Taliban. Another $2.5 billion goes toward care and shelter for undocumented migrant children who crossed the border alone while the government reviews their status.

From the telehealth front

Telehealth usage was four times higher than a year ago, but the industry and patients are still grappling with growing pains including service limitations, difficulty accessing appointments and inconsistent care, a survey from J.D. Power found.

From 2020 to 2021, overall satisfaction with both direct-to-consumer and payer-sponsored telehealth services declined, according to the survey. Patients frequently cited limited services, lack of awareness of costs and confusing technology requirements.

Among direct-to-consumer brands, Teladoc ranked highest for telehealth satisfaction, followed by MDLive. Among payer-sponsored telehealth services, UnitedHealthcare ranked the highest, followed by Humana and Kaiser Foundation Health Plan, both in a tie for second, the survey found.

Despite the wide-ranging expansion of telehealth in the past year, there is still a broad swath of the U.S. population it has largely failed to reach: the 57 million people in rural parts of the country.

Even now, as employers rush to add virtual care to their benefits, many telehealth companies have avoided rural areas. Several acknowledged to STAT that most of their users remain in urban and suburban areas, and they’ve made far less progress than they’d like to in reaching rural patients. The companies recognize they face an uphill battle. Beyond the foundational barrier of broadband access, providers must contend with questions about reimbursement rates, strict rules on interstate licensing, and a hazy road map without clear inroads for reaching rural patients and providers.

“Honestly, as much as our mission statement fits well with rural health care, we haven’t really made enough progress to date around this work,” Brad Younggren, the chief medical officer of telehealth company 98point6, told STAT.

As it is Thursday from the miscellany department

  • Recycle Intelligence discusses “Lessons learned from Aetna, Cleveland Clinic’s Joint ACO Mode / Leaders from Aetna and Cleveland Clinic reflect on the first year of their joint ACO and health plan and share how others can deliver value-based care to their local markets.” Check it out.

Scientists have unveiled new maps of the protein networks underlying different types of cancer, offering a potentially clearer way to see what’s driving the disease and to find therapeutic targets.

Sequencing the genetic information of tumors can provide a trove of data about the mutations contained in those cancer cells. Some of those mutations help doctors figure out the best way to treat a patient, but others remain more of a mystery than a clear instruction manual. Many are exceedingly rare, or there are so many mutations it’s not clear what’s fueling the cancer.

In a quest to come up with more practical and actionable tools, experts have been looking beyond the genes. Instead, they’re mapping out the proteins the genes encode and the interactions among those proteins in hopes of getting a clearer view of cancer-propelling pathways. And in a series of papers published Thursday in the journal Science, a team of researchers outlined those “protein-protein interaction” maps for certain cancers and explain how charting those landscapes and others like them could reveal insights about patients’ prognoses, point to drugs to try for particular patients, and perhaps identify targets for new therapies.

  • STAT News also seeks to predict what will become of the COVID pandemic this coming winter. The article hopefully concludes

Barney Graham, who led the vaccine design work that laid the foundation for many of the current Covid vaccines, is hopeful, though, that in Delta the virus has hit a sweet spot that will eventually undermine it.

“I’m hoping the virus has gotten itself to a point where it’s basically trapped now,” said Graham, who was deputy director of the NIH’s Vaccine Research Center until his retirement at the end of August. “That it can’t get any better at transmission, and any adaptation it makes in the immune response is going to make it less transmissible.”

  • In support of this optimism, Reuters reports that

Laboratory studies show that Merck & Co’s (MRK.N) experimental oral COVID-19 antiviral drug, molnupiravir, is likely to be effective against known variants of the coronavirus, including the dominant, highly transmissible Delta, the company said on Wednesday.

Since molnupiravir does not target the spike protein of the virus – the target of all current COVID-19 vaccines – which defines the differences between the variants, the drug should be equally effective as the virus continues to evolve, said Jay Grobler, head of infectious disease and vaccines at Merck.

Molnupiravir instead targets the viral polymerase, an enzyme needed for the virus to make copies of itself. It is designed to work by introducing errors into the genetic code of the virus.

Data shows that the drug is most effective when given early in the course of infection, Merck said.

What’s more, the Merck drug is administered in pill form.

OPM Announces 2022 FEHB and FEDVIP Premiums

OPM Headquarters a/k/a the Theodore Roosevelt Building

OPM, as promised, announced 2022 FEHB and FEDVIP premiums before the end of September. Here are links to the OPM website for 2022 FEHB plan premiums and its website for 2022 FEDVIP plan premiums. In addition, here are links to related articles from the Washington Post, GovExec, Federal News Network, FedWeek, and the Federal Times which offered a separate article on FEDVIP.

The Washington Post summed it up as follows: “Premiums for federal employees will rise by 3.8 percent on average in 2022, the second straight year of moderate increases despite the coronavirus pandemic, the government announced Wednesday.” That’s a credit to OPM and the carriers as well as this competitive program. Also as OPM usually explains, the average increase is shown before the Open Season results when federal and postal employees and annuitants can elect lower premium plans from Nov. 8 through Dec. 13.

From Capitol Hill, the Wall Street Journal reports this evening that

Party leaders are racing to unify Democrats around changes to a separate $3.5 trillion healthcare, education and climate package, which progressives want to see advance as a condition of supporting the infrastructure bill in the narrowly divided House. Speaker Nancy Pelosi (D., Calif.) so far has stuck to her plan to bring the infrastructure bill up for a vote Thursday, saying she was taking it “one hour at a time,” though she opened the door to further delay if talks don’t progress. * * *

The Thursday deadline for the infrastructure vote is one of several scheduling crunches Democrats face in the coming days. They are also rushing to pass a stand-alone measure extending government funding, currently set to expire on Friday at 12:01 a.m., through Dec. 3. Republicans and Democrats in the Senate were nearing an agreement to pass the spending patch Thursday before sending it to the House. 

From the Delta variant front, STAT News tells us that “People who’ve received a third dose of a Covid-19 vaccine are reporting rates of side effects similar to those after the second dose, according to data released Tuesday by the Centers for Disease Control and Prevention.”

From the No Surprises Act front, OMB’s Office of Information and Regulatory Affairs has concluded its review of the second interim final rule which concerns the independent dispute resolution process. This means that the regulators can timely release information on the rule this week, if not the entire rule itself.

From the health equity front, Fierce Healthcare reports that “CVS Caremark is expanding its health equity efforts, setting goals that specifically target diseases that disproportionately impact patients of color, such as HIV and sickle cell disease.”

In other healthcare news

  • HHS’s Agency for Healthcare Quality and Research reminds us that today is ‘World Heart Day — an observance that aims to improve how we understand, prevent, and manage the disease.” AHRQ describe its efforts to improve heart health.
  • Healthcare Dive without grinding an axe informs us that

U.S. health insurance markets have become increasingly concentrated over the past half decade, according to a new report from the American Medical Association, which argues payer M&A results in rising costs and fewer care options for patients, but largely excludes the impact of provider consolidation in driving those trends.

Almost three-fourths of metropolitan statistical areas were highly concentrated in 2020 according to federal guidelines used by the Department of Justice and Federal Trade Commission, up from 71% in 2014. Of markets that were already highly concentrated in 2014, 54% become more concentrated as of last year, while 26% of markets that were not highly concentrated become so by 2020, the AMA said.

The medical association’s study is the latest salvo in a messaging war between provider and payer lobbies as they work to shift the blame for rapidly rising medical costs in the U.S.

  • The National Institutes of Health reports on the efforts of its “Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM, is an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis.”