Tuesday Tidbits

Rx coverage

Tuesday Tidbits

David Ermer–COVID-19, COVID-19 vaccine, Rx coverage, Telehealth, U.S. Healthcare–
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.

Tuesday’s Tidbits

David Ermer–Congress, COVID-19, COVID-19 testing, COVID-19 vaccine, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill, Roll Call reports that “The House passed a catchall budget package Tuesday [along party lines] that’s intended to avoid a partial government shutdown and debt limit crisis, but it seems likely to come back for a do-over once the Senate works its will.” The Republicans are objecting to combining the debt limit increase with the stop gap measure because “Treasury has said Congress needs to act sometime next month; Wrightson ICAP, a private investment advisory firm, said this week the drop-dead deadline was likely Oct. 25 or 26.”  

Here’s a stunner for you from the Roll Call article:

The bill includes language to temporarily extend how fentanyl — a highly potent opioid — is classified. Fentanyl is responsible for a lion’s share of drug overdose deaths, which have been on the rise during the COVID-19 pandemic. The bill would extend fentanyl’s status as a so-called “Schedule 1” drug until Jan. 28, 2022. Under current law, the drug would lose its status as a drug with a high risk for abuse on Oct. 22. 

From the Delta variant front —

  • According to the American Hospital Association, “Johnson & Johnson today said its phase 3 trial data confirms its vaccine’s durability and provided evidence of a second, booster shot’s effectiveness against COVID-19. The drug maker said that, over the course of its ongoing phase 3 trial, it found no evidence of the vaccine’s reduced effectiveness, which J&J said is 79% for preventing COVID-19-related infections and 81% for preventing COVID-19-related hospitalizations. J&J furthermore found that a booster shot administered 56 days after an initial dose provided 100% protection against severe/critical COVID-19 for at least 14 days post-final vaccination and 94% protection against symptomatic (moderate to severe/critical) COVID-19 in the U.S. Additionally, boosters resulted in antibody levels four to six times higher than those netted from a single dose.”
  • David Leonhardt in the New York Times understandably criticized federal agencies for dropping the ball on production of rapid COVID tests. “Other countries are awash in Covid tests. The U.S. is not.”

Stefanie Friedhoff, a professor at Brown University’s School of Public Health, recently returned from a visit to Germany and wrote on Twitter about the many benefits of rapid testing that she had seen. A friend’s husband has Parkinson’s disease, and the friend leaves a batch of tests in her hallway for people to take before they enter the home. The day care center where Friedhoff’s sister works has stayed open throughout the pandemic, because the staff and children take frequent tests.

“Imagine what ubiquitous cheap testing could do in the U.S.,” Friedhoff wrote. “It is incomprehensible how the U.S. has failed on testing.”

  • The FEHBlog recalls writing last year at this time about the importance of a vaccine, rapid testing, and a treatment for recently symptomatic people in order to bring the pandemic to a close. We should be grateful for the vaccines but we wouldn’t be in this much of a fix if we also had rapid testing and earlier treatment options.

The American Hospital Association also reports that

U.S. hospitals will lose an estimated $54 billion in net income this year, even after federal relief funds, as higher labor and other expenses and sicker patients impact their financial health during the ongoing COVID-19 pandemic, according to a report by Kaufman, Hall & Associates released today by the AHA. More than a third of hospitals are expected to end 2021 with negative margins. 

“With cases and hospitalizations at elevated levels again due to the rapid spread of the Delta variant, physicians, nurses and other hospital caregivers and personnel are working tirelessly to care for COVID-19 patients and all others who need care,” said AHA President and CEO Rick Pollack. “At the same time, hospitals are experiencing profound headwinds that will continue throughout the rest of 2021.”

From the Rx front

  • Medcity News reports that “The FDA has approved the first biosimilar that references the blockbuster Roche drug Lucentis. The Biogen and Samsung BioLogics joint venture that developed the biologic product have approval to treat three eye conditions that lead to vision loss.” Bravo.

From the tidbits department

Infants who seemed headed for autism spectrum disorder (ASD) had milder symptoms as toddlers if their caregivers were subject to a social communication intervention when infants were just 1 year of age, a randomized clinical trial found.

Infants whose families participated in the intervention exhibited significantly milder ASD symptoms 12 months later compared to those in the control group. They also had lower odds of being diagnosed with ASD by an independent clinician at age 3 years (6.7% vs 20.5%, OR 0.18, 95% CI 0.00-0.68), according to the study group led by Andrew Whitehouse, PhD, of the University of Western Australia.

Non-career employees at the U.S. Postal Service are significantly more likely to get injured on the job and leave their positions than employees with a permanent status, according to a Sept. 16 Government Accountability Office report.

Employees without permanent status at USPS receive lower pay and fewer benefits than their career counterparts, often under the assumption that they will have a path to a career position in the future. But according to GAO, those non-career employees, of which there are more than 200,000 across the U.S., had 50 percent higher rates of injury than career positions and reported the incidents to the Federal Employees’ Compensation Program 43 percent more often.

  • Fierce Healthcare tells us that

Humana leads the industry on customer experience scores and is the only major national payer to land above the industry average, according to a new report from analysts at Forrester.

Forrester polled members of 17 of the largest health plans in the country and found an industry average score of 70.2 on a 100-point scale, which the organization categorizes as an “OK” rating. In 2020, payers averaged 67.5 points, according to the report.

At the top of the list, Humana earned a 74.8 score, dethroning 2020’s top health plan, Florida Blue, which fell to fourth place with a 71.9. Kaiser Permanente’s health plan landed in the second-place slot with a 73.8 score, and Highmark placed third, earning a 72.9.

Rounding out the top five is Blue Cross Blue Shield of Michigan, which rose from a 10th-place ranking in 2020’s report, Forrester found.

Congrats, Humana and the other high scorers.

Friday Stats and More

David Ermer–ACA, COVID-19, Rx coverage, U.S. Healthcare–

Based on data from the Centers for Disease Control’s COVID Data Tracker, here is the FEHBlog’s weekly chart of new COVID cases for 2021:

The CDC observes “After experiencing a brief decline in COVID-19 cases, the United States is once again seeing an increase in cases in most of the country.”

Here’s a link to the CDC’s weekly chart of COVID hospitalizations which shows a drop in the seven day moving average.

Here’s the FEHBlog’s weekly chart of new COVID deaths for 2021:

Finally here is the FEHBlog’s weekly chart of COVID vaccines distributed and administered from the 51st week of 2020 through the 37th week of 2021, ending last Wednesday September 15.

There are 180.6 million fully vaccinated Americans, or 63.6% of the vaccination eligible population (age 12 and older) and 31 million more who are waiting for their second dose.

The Wall Street Journal informs us that

The Covid-19 vaccine made by Moderna Inc. is more effective at keeping people out of the hospital than those from Pfizer Inc. and partner BioNTech SE or Johnson & Johnson, new research indicates.

In a study published by the Centers for Disease Control and Prevention on Friday, researchers studied more than 3,600 adults who were hospitalized in the U.S. between March and August of 2021. They looked at people who were admitted to 21 hospitals who had at least one Covid-19 symptom and a positive PCR or antigen test, as well as patients who were admitted to a hospital who tested negative for Covid-19. They then compared their vaccination status and which vaccine they received.

The researchers found that the Moderna vaccine’s effectiveness against hospitalization was 93%, compared with 88% for Pfizer-BioNTech’s and 71% for J&J’s. The effectiveness of the Moderna and Pfizer-BioNTech vaccines also seemed to stand up better over time than that of J&J’s vaccine. The Moderna vaccine’s effectiveness against hospitalization dropped to 92% after 120 days, while Pfizer-BioNTech’s dropped to 77%. After just 28 days, the J&J vaccine’s effectiveness fell to 68%.

And the administrative suspense is over, STAT News tells us

An advisory panel to the Food and Drug Administration on Friday recommended against a booster dose of a Covid-19 vaccine for most Americans at this time — a major rebuke to the Biden administration — but voted unanimously to recommend one to Americans who are 65 or older.

The FDA is not required to follow the recommendation of its advisory committees but generally does. If the recommendation is adopted by the FDA and Centers for Disease Control and Prevention, it would put the U.S. policy on a par with countries like the United Kingdom.

After seven hours of deliberation, members of the Vaccines and Related Biological Products Advisory Committee voted 16 to 2 against a proposal to administer a third dose of the vaccine developed by Pfizer and BioNTech to individuals 16 years and older. The vote to recommend a booster to people 65 years and older — as well as people who are at risk of severe Covid — was 18 to 0.

It was not immediately clear who would qualify as high risk; fleshing that out will likely fall to the CDC’s advisory committee, the Advisory Committee on Immunization Practices.

You will be able to knock the FEHBlog down with a feather if acting FDA Commissioner Janet Woodcock overrules the advisory committee given the Aduhelm debacle earlier this year. Also the outcome strikes the FEHBlog as a reasonable Goldilocks solution to the thorny problem.

Speaking of the expensive Alzheimer’s Disease drug Aduhelm, Fierce Pharma reports that

Data collected from a survey of 74 neurologists collected at the start of the month found that at least two thirds of respondents anticipate having at least some patients on Aduhelm by March 2022, according to Spherix Global Insights’ newly launched drug report released on Thursday. That could result in “an estimated brand share substantially higher than that projected back in August,” the report found. 

he results indicate increased signs of optimism, according to Spherix, with small increases in the prescriber base and number of new patients compared to the stagnant trends found in the first few months following Aduhelm’s June FDA nod. In Spherix’s mid-July report, only about one fourth (27%) of responding physicians had planned to prescribe Aduhelm in the next few months.

Biogen’s prospects should improve in the coming weeks, Spherix estimates. According to the report, the prescriber base will likely grow by nearly 50% within that time, which could lead to twice the number of new patient initiations when compared with August.

Despite the maelstrom of negative press Biogen’s accelerated FDA nod has garnered, one in seven newly diagnosed patients with the memory-robbing disease are considered potential Aduhelm candidates, Spherix said. 

Therefore, Aduhelm’s long-term success “does not appear to be markedly limited by physician willingness to prescribe” the treatment or “clinical determination of patient eligibility.” 

In HHS News —

  • Today, the Biden-Harris Administration announced a $2.1 billion investment to improve infection prevention and control activities across the U.S. public health and healthcare sectors. The Biden-Harris Administration, working through the Centers for Disease Control and Prevention (CDC), is investing American Rescue Plan funding to strengthen and equip state, local, and territorial public health departments and other partner organizations with the resources needed to better fight infections in U.S. healthcare facilities, including COVID-19 and other known and emerging infectious diseases.”
  • Also today a record breaking third Affordable Care Act notice of benefit and rate parameters notice for 2022 was finalized. Fierce Healthcare tells us that “For 2022, insurers will face an increase in the federally run marketplace user fee rate to 2.75% of their premiums and the state-run exchanges to 2.25%. That is a change from the user fee finalized on Jan. 19 under the Trump administration, which called for a user fee of 2.25% for the federal marketplace and 1.75% for the state-run exchanges. The rule would also extend the open enrollment period by 30 days for ACA signups, with the new deadline on the federally run exchanges being Jan. 15. Open enrollment for the federal exchanges still starts on Nov. 1. * * * CMS is also creating a new special enrollment period that targets low-income individuals through HealthCare.gov. The goal is to target people who could be eligible for boosted subsidies that were included in the American Rescue Plan Act but expire after the 2022 coverage year. Congress is debating whether to extend those subsidies as part of a $3.5 trillion infrastructure package.”

Weekend Update

David Ermer–CMS, Congress, COVID-19, COVID-19 vaccine, Rx coverage–
Photo by Dane Deaner on Unsplash

The U.S. House of Representative both will be engaged in committee work through Wednesday this week until Yom Kippur begins on Wednesday evening. The Senate also will be engaged in floor voting for the same period. Committee work principally will focus on the details of the $3.5 trillion budget reconciliation bill and a related Plan B measures including a stopgap extension of federal funding past September 30 and addressing the debt ceiling.

On the Delta variant front

The Wall Street Journal explains that epidemiologists no long think that COVID-19 can be eradicated. We have a good shot at the virus becoming endemic / a routine treatable illness.

When or even whether Covid-19 settles into that status depends on how many more people get vaccinated and how soon, said Adolfo Garcia-Sastre, director of the Global Health and Emerging Pathogens Institute at the Icahn School of Medicine at Mount Sinai in New York.

For Covid-19 to become mild, most people will need some immunity, which studies have shown reduces the severity of the disease. Infections provide some immunity, but at risk of severe illness, death and further spread of the virus, compared with vaccines. People could become vulnerable to SARS-CoV-2 if that immunity erodes or is weak, or if the virus mutates.

“The more people who are vaccinated, the less problems there are going to be,” Dr. Garcia-Sastre said.

The Journal’s Numbers columnist explains why COVID-19 vaccination boosters will be necessary.

“We’re fortunate with tetanus, diphtheria, measles and vaccinia,” Dr. [Mark] Slifka [from the Oregon Health & Science University] said. “We have identified what the threshold of protection is. You track antibody decline over time, and if you know the threshold of protection, you can calculate durability of protection. With Covid, we don’t know.”

Complicating things further, viruses and bacteria that mutate to escape the body’s immune response are harder to control.

Measles, mumps, rubella and chickenpox hardly mutate at all, but at least eight variants of SARS-CoV-2, the virus that causes Covid-19, have been found, according to the British Medical Journal.  

“It does make it more complicated for the vaccine to work,” Dr. Slifka said. “You’re chasing multiple targets over time. Flu also mutates. With flu, we’ve adjusted by making a new flu vaccine each year that as closely as possible matches the new strain of flu.”

The FDA’s Vaccines Advisory Committee meets on the topic of COVID-19 boosters this Friday September 17. The CDC’s Advisory Committee on Immunization Practices has scheduled a complementary meeting for September 29.

The FEHBlog ran across this interesting WebMD article titled “Monoclonal Antibodies vs. Vaccines vs. COVID-19: What to Know.” “‘As hospitalizations go up nationwide, we have a therapy here that can mitigate that,’ says William Fales, MD, medical director of the Michigan Department of Health and Human Services Division of EMS and Trauma. Getting monoclonal antibodies is one of ‘the best things you can do once you’re positive.’” However, the vaccine’s protection against COVID-19 has a much longer duration than this treatment. “There are two authorized uses for monoclonal antibodies: To treat or stop COVID-19’s progression in a high-risk person who tests positive, and to prevent COVID-19 in a high-risk person who’s been exposed.” The treatment is administered while hospitalized or while outpatient at an infusion center.

In RX news, Managed Healthcare Executive reports

The FDA has approved 30 biosimilars and 21 have been launched. But it won’t be till biosimilars for some of the more widely prescribed biologics are on the market before biosimilars really start to have a major impact on American healthcare and its cost, according to a top-ranking executive at OptumRx.

“We’re still a few years away from the point at which the most widely-utilized … products in the U.S. today will be available as biosimilars,” Savitha Vivian, senior vice president of clinical and formulary Services for OptumRx, said in an interview with Managed Healthcare Executive®. “And that’s really what we’re looking for, because that’s going to enable a more sizable and impactful bottom-line savings.”

Ms. Vivian expects Humira to hit the bio-similar market in 2023.

“Another significant biosimilar launch that is still two to three years away from one for Novo Nordisk’s insulin aspart injection (Novolog), a “highly utilized medication, especially in the outpatient setting,” noted Vivian.Biosimilars for Genentech’s Actemra (tocilizumab), a medication for rheumatoid arthritis and other forms of arthritis, and Stelara (ustekinumab), Janssen’s immunosuppressive drug for plaque psoriasis and psoriatic arthritis, are also two or three years away.”

Patient and provider comfort with biosimilars is still a “critical barrier” to the adoption of biosimilars, she said.

Switching therapies in patients who are stable on the biosimilar’s reference product to the biosimilar is not typically recommended, according to Vivian. “So from a clinical perspective, we need to be cautious in implementing strategies that force these types of switching.”Instead, she said, “what we really need is data showing that there’s really no additional risk from switching therapies in these hard-to-treat or hard-to-control chronic diseases. That’s going to really increase the confidence for prescribers to start using biosimilars in … those stable patients.”

Another barrier is a lack of interchangeability in biosimilars, with notable exception of Semglee (insulin glargine-yfgn), which was FDA-approved as biosimilar to, and interchangeable with Lantus (insulin glargine) this summer. In order to demonstrate interchangeability, studies must show there is no additional risk or reduced efficacy if a patient switches back and forth between the interchangeable biosimilar and the reference product.

Tuesday’s Tidbits

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

On the Delta variant front and acccording to the CDC’s COVID Data Tracker, the United States reached two data points today — the number of COVID cases now exceeds 40 million and the percentage of Americans aged 18 and over who have received at least one dose of a COVID-19 vaccine reached 75%.

At the end of 2020, the number of cases according to the CDC stood at 20 million. In his blog, National Institutes of Health Director Francis Collins discusses a recent Nature study estimating that “the true number of [COVID] infections by the end of 2020 at more than 100 million [1]. That’s equal to just under a third of the U.S. population of 328 million. This revised number shows just how rapidly this novel coronavirus spread through the country last year. It also brings home just how timely the vaccines have been—and continue to be in 2021—to protect our nation’s health in this time of pandemic.” It also suggests to the FEHBlog that we may to closer to effective herd immunity in some areas of the U.S. than generally thought.

Also David Leonhardt in today’s New York Times tells us about another way to look at the situation.

The C.D.C. reported a terrifying fact in July: Vaccinated people with the Delta variant of the Covid virus carried roughly the same viral load in their noses and throats as unvaccinated people.

The news seemed to suggest that even the vaccinated were highly vulnerable to getting infected and passing the virus to others. Sure enough, stories about vaccinated people getting Covid — so-called breakthrough infections — were all around this summer: at a party in Provincetown, Mass.; among the Chicago Cubs; on Capitol Hill. Delta seemed as if it might be changing everything.

In recent weeks, however, more data has become available, and it suggests that the true picture is less alarming. Yes, Delta has increased the chances of getting Covid for almost everyone. But if you’re vaccinated, a Covid infection is still uncommon, and those high viral loads are not as worrisome as they initially sounded.

How small are the chances of the average vaccinated American contracting Covid? Probably about one in 5,000 per day, and even lower for people who take precautions or live in a highly vaccinated community. * * *

I will confess to one bit of hesitation about walking you through the data on breakthrough infections: It’s not clear how much we should be worrying about them. For the vaccinated, Covid resembles the flu and usually a mild one. Society does not grind to a halt over the flu.

In Britain, many people have become comfortable with the current Covid risks. The vaccines make serious illness rare in adults, and the risks to young children are so low that Britain may never recommend that most receive the vaccine. Letting the virus continue to dominate life, on the other hand, has large costs.

“There’s a feeling that finally we can breathe; we can start trying to get back what we’ve lost,” Devi Sridhar, the head of the global public health program at the University of Edinburgh, told The Times.

Well put, Mr. Leonhardt, as usual.

From the federal employee benefits front, OPM posted on the Federal Register website today a notice of changes to Federal Group Life Insurance premium rates for “Employee Basic Insurance, Option A (most age bands), Option B (most age bands), Option C (most age bands), and Post-Retirement Basic Insurance. These rates will be effective the first pay period beginning on or after October 1, 2021.”

From the tidbits department

  • Federal News Network reports that “The White House is proposing billions of dollars in supplemental funding for disaster relief and other programs, which it’s asking Congress to attach to a short-term continuing resolution that will be critical toward avoiding a government shutdown at the end of the month. ‘With the end of the fiscal year rapidly approaching, it’s clear that Congress will need to pass a short term continuing resolution to provide more time for the fiscal 2022 process to unfold,’ Shalanda Young, the Office of Management and Budget’s acting director, said Tuesday in a blog post.” 
  • Fierce Healthcare informs us that “The American Medical Association [“AMA”] released updates to its medical codes for 2022 with many tied to new technology services and the administration of COVID-19 vaccines. The AMA made 405 changes in the 2022 Current Procedural Terminology code set, including 249 new codes, 63 deletions and 93 revisions. The changes will take effect Jan. 1. ” The CPT is recognized as a HIPAA electronic transaction code set.
  • AP News reports that “Four companies in the drug industry said Saturday that enough states had agreed to a settlement of lawsuits over the opioid crisis for them to move ahead with the $26 billion deal. An announcement from the three largest U.S. drug distribution companies and a confirmation from drugmaker Johnson & Johnson, which had previously announced that it would move ahead, came Saturday. That was the deadline for the companies to decide whether there was enough buy-in to continue the settlement plan. * * * Together, the settlements are likely to represent the biggest piece of a string of settlements between companies in the drug industry and state and local governments over the addiction and overdose epidemic in the U.S.”
  • Healthcare Dive tells us that “The use of telehealth for patient visits seems to have leveled off at 20% or fewer of all appointments, more than a year and a half after COVID-19 first spurred an unprecedented jump in utilization, according to a new survey from KLAS Research and the Center for Connected Medicine.”
  • The AMA discusses “what doctors wish patients knew about a prediabetes diagnosis,” which of course is a fairly common diagnosis in our country.
  • The Wall Street Journal continues its series on the Future of Everything in healthcare with an article about sensor studded smart clothes. “From a prescription bra that signals cardiac arrest to a mosquito-proof textile, startups and scientists are developing garments for healthier living.”

Here comes Open Season

David Ermer–COVID-19, COVID-19 vaccine, Federal employment benefits, Mental health care, OPM, Rx coverage, U.S. Healthcare–
OPM Headquarters a/k/a the Theodore Roosevelt Building

Today OPM issued its first notice about the Federal Benefits Open Season which will run this year from Monday November 8 through Monday December 13.

[Benefits Administration Letter] BAL 21-401 provides guidance on the upcoming Federal Benefits Open Season for the Federal Flexible Spending Account Program (FSAFEDS), Federal Employees Dental and Vision Insurance Program (FEDVIP) and the Federal Employees Health Benefits (FEHB) Program. Attached to this BAL is a sample email and “Circle Round Your Benefits” flyer. This BAL and the attachments will be posted on our website at www.opm.gov/retirement-services/publications-forms/benefits-administration-letters/.

The BAL makes a couple of points worth noting and includes a timeline which also is partially excerpted below:

Employees find Open Season fairs a valuable resource for getting Open Season information. Due to COVID-19, we strongly encourage you to assess how in-person benefit fairs will be impacted. Consider other ways to provide information to employees such as virtual events, webcasts, or webinars. Many health plans host virtual events to provide information about Open Season to their enrollees and others. You may contact health plans for ideas and suggestions on providing information. 

2022 rates announced and posted on OPM website Late September 
BAL 21-403 Significant Plan Changes Anticipated Issue Date: Early-to Mid-October 
Open Season information posted on OPM website Early November 

From the Delta variant front

The Washington Post informs us that

The Food and Drug Administration has scheduled a key meeting on coronavirus boosters with its outside advisers for Sept. 17 — just a few days before the Biden administration’s planned starting date for an extra-shot campaign.

The session, which will be public, could add much-needed clarity and transparency to a decision-making process that some people have criticized as confusing. But it also could fuel more controversy over an administration position some experts regard as premature.

Of course, the Biden administration could reduce the time pressure by postponing its “plan starting date.”

On a related note, The Wall Street Journal reports that

The Food and Drug Administration is considering whether to authorize a lower dose of Moderna Inc.’s Covid-19 vaccine for boosters than the dose given in the first two shots, people familiar with the deliberations said. 

Moderna said Wednesday it is asking the FDA to authorize a 50 microgram dose, half the dosage of the first two shots. Some in the government are leaning toward authorizing the 100 microgram dose, the people said, because of concerns a lower-dose booster might not offer a durable enough boost to counter fast-changing variants of Covid-19.

No final decision has been made, the people said, as the FDA is still reviewing data from studies that tested boosters using the different doses. People who have seen the data said both doses produce a strong immune response.

Presumably a smaller dose would reduce side effects.

CNBC brings us up to date on the other COVID-19 variants of concerns besides Delta.

The CDC is monitoring four variants “of concern,” including delta, which was first detected in India and is the most prevalent variant currently circulating in the U.S.; alpha, first detected in the U.K.; beta, first detected in South Africa, and gamma, first detected in Brazil. A variant of concern is generally defined as a mutated strain that’s either more contagious, more deadly or more resistant to current vaccines and treatments.

It’s also keeping a close watch on four other variants of interest — including lambda, first identified in Peru [and presumably mu, first identified in Columbia] — that have caused outbreaks in multiple countries and have genetic changes that could make them more dangerous than other strains.

Also from the FEHB front —

Fedweek offers short but accurate guidance about OPM’s FEHB disputed claims review process.

Health Payer Intelligence informs us that “The Alliance of Community Health Plans (ACHP) is urging the federal government to take action and lower prescription drug prices with a set of recommended actions.” In addition to recommendations for Medicare Part D and the biosimilar market, ACHP makes broader recommendations such as

Targeting drug companies’ unjustifiable raising of drug prices. At the beginning of 2021, 735 drugs prices increased up to 10 percent without reason. Prescription drug prices often increase faster than the inflation rate, therefore ACHP recommended that drug manufacturers should have to provide rebates for drug price increase above the inflation rate. Drug companies should also have to follow a price transparency rule that would require manufacturers to report and justify price increases, ACHP stated.

The federal government [should] encourage the use of transparent fee-based pharmacy benefit managers (PBMs). Traditional PBMs are typically not transparent about rebates, which can encourage high-cost drug use, whereas transparent fee-based PBMs pass rebates and discounts onto payers and earn revenue through a clear administrative fee.

ACHP may be interested to know that OPM imposed a strict regime of transparent pricing on experience rated FEHB plans ten years ago. Transparent pricing, which OPM continues to fine tune, facilitates OPM audits of PBMs but does not generate substantial new savings for carriers. Instead, transparent pricing shifts PBM fees from a share of rebates and such to “a clear administrative fee” at levels which simply were not charged before 2011. It is important to add that in 2010 OPM also mandated that experience rated carriers rebid their PBM contracts triennially and those market competitions have generated substantial new savings for carriers. Also as the FEHBlog has mentioned, if OPM were to allow FEHB carriers to offer Medicare Part D EGWPs, as Congress authorized in 2003, the resulting savings, in the FEHBlog’s estimation, would generate blockbuster new savings that would actually lower FEHB premiums.

From the miscellany department —

  • MedPage Today tells us that “The FDA approved the injectable, long-acting atypical antipsychotic paliperidone palmitate (Invega Hafyera), a twice-yearly treatment for schizophrenia in adults who have been adequately treated with the 1- or 3-month versions of paliperidone palmitate, Janssen announced.
  • OPM released weather leave guidance today according to Govexec.
  • Healthcare Dive reports that “Four out of six infections routinely tracked at U.S. hospitals rose significantly during the COVID-19 pandemic, according to a Centers for Disease Control and Prevention data analysis published in the journal of the Society for Healthcare Epidemiology of America on Thursday. From 2019 to 2020, major increases were observed in central-line associated bloodstream infections, catheter-associated urinary tract infections, ventilator-associated events and antibiotic resistant staph infections, according to the report.”

Midweek update

David Ermer–CDC, COVID-19, COVID-19 vaccine, Employee Wellness Programs, Mental health care, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Piron Guillaume on Unsplash

In addition to being Wednesday, today is September 1 which marks the beginning of at least three healthcare related observances”

  • Each September, the American Medical Association’s (AMA) Women Physicians Section (WPS) honors physicians who have offered their time, wisdom and support to advance women with careers in medicine.
  • September is Sepsis Awareness Month. Here is a link to the Center for Disease Control’s Sepsis awareness page.
  • September is also National Recovery Month. The AMA identifies four ways that the Biden Administration can reduce the number of drug overdose deaths.

From the Delta variant front

The FEHBlog’s favorite newspaper columnist is David Leonhardt who writes a morning column for the New York Times. Mr. Leonhardt raises questions often on the FEHBlog’s mind after exploring the question with experts.This morning he pondered whether

the Delta-fueled Covid-19 surge in the U.S. finally peaked?

The number of new daily U.S. cases has risen less over the past week than at any point since June. * * *

Since the pandemic began, Covid has often followed a regular — if mysterious — cycle. In one country after another, the number of new cases has often surged for roughly two months before starting to fall. The Delta variant, despite its intense contagiousness, has followed this pattern. * * *

In the U.S., the start of the school year could similarly spark outbreaks this month. The country will need to wait a few more weeks to know. In the meantime, one strategy continues to be more effective than any other in beating back the pandemic: “Vaccine, vaccine, vaccine,” as [University of Minnesota epidemiologist Michael] Osterholm says. Or as [Johns Hopkins epidemiologist Jennifer] Nuzzo puts it, “Our top goal has to be first shots in arms.”

Hope springs eternal.

Regading increasing the number of vaccinations, Bloomberg reports today that

Vaccine mandates are set to get more common in the workplace. 

A majority of U.S. employers — 52% — are planning or considering requirements for a Covid-19 shot by the end of the year, according to a survey released Wednesday by consultant Willis Towers Watson. That’s more than double the 21% of companies polled that currently have some form of mandate. 

The options vary, ranging from a strict order for all employees to limiting access to certain areas to inoculated workers. About 14% of respondents also said they are weighing a health-care surcharge for people who choose not to get the vaccine, while 1% are planning to impose one, according to the survey of 961 employers, conducted Aug. 18-25.

Also Fierce Biotech explores what’s next in the mRNA pipeline. Principally for the two COVID mRNA vaccine companies with large war chests

Moderna executives tout the company’s pipeline often—so we’ll be brief here. A cytomegalovirus candidate is the furthest along in the company’s prophylactic vaccine program, while other mid-stage assets include a personalized cancer vaccine and a localized regenerative therapeutic for the heart condition myocardial ischemia.

BioNTech, meanwhile, has dozens of assets in development for a host of common conditions: malaria, tuberculosis and even certain allergies. But where the German biotech is really making a mark is in oncology, where dozens of vaccines and therapeutics are in development. Just one is in phase 2: the Roche-partnered melanoma therapy BNT122. That drug is combined with Merck & Co.’s blockbuster Keytruda to treat metastatic melanoma in a study conducted with Roche’s Genentech.

The article also discusses where other large drug manufacturers stand in the developing market.

From the bankruptcy front, the Wall Street Journal reports that

OxyContin maker Purdue Pharma LP won court approval of a $4.5 billion bankruptcy settlement that shields its owners, members of the Sackler family, from lawsuits accusing them of contributing to the nation’s opioid epidemic in exchange for providing funding to combat the crisis.

Judge Robert Drain of the U.S. Bankruptcy Court in White Plains, N.Y., said Wednesday he will confirm a restructuring plan that will transform Purdue into a public benefit company and settle civil lawsuits filed by governments and opioid victims against the drugmaker and its owners. 

The ruling can be appealed by the handful of federal and state authorities that opposed Purdue’s bankruptcy-exit plan and argued at trial that the settlement structure is unconstitutional and the Sacklers aren’t contributing enough of their wealth. Purdue’s family owners collected more than $10 billion from the company between 2008 and 2017, about half of which went to taxes or was reinvested in the business.

From the miscellany front

  • Homeland Security Today informs us that “The Biden Administration, in a collaboration between the General Services Administration, the White House Office of Management and Budget, the Office of Personnel Management, the Cybersecurity and Infrastructure Security Agency, and the White House Office of Science and Technology Policy, announced the U.S. Digital Corps, a new two-year fellowship that will recruit early-career technologists to contribute to high-impact efforts across the federal government. This program will work to advance the Administration priorities of coronavirus response, economic recovery, cybersecurity, and streamlining government services.” Best of luck with this initiative.
  • The Washington Post reports that “Childhood obesity rose significantly during the pandemic,according to a new study. The greatest change was among children ages 5 to 11, who gained an average of more than five pounds, adjusted for height, according to the study published in Journal of the American Medical Association (JAMA) Network. For the average 5-year-old (about 40 pounds), that’s a 12.5 percent weight gain. For the average 11-year-old (about 82 pounds), it’s a 6 percent weight gain, according to the study. Before the pandemic, about 36 percent of 5- to 11-year-olds were considered overweight or obese, and that increased to 45.7 percent. ‘Significant weight gain occurred during the covid-19 pandemic among youths in Kaiser Permanente Southern California, especially among the youngest children,’ the study concluded. ‘These findings, if generalizable to the U.S., suggest an increase in pediatric obesity due to the pandemic.’” No bueno.
  • Employee Benefits News offers an engaging article titled “Affordable ways to help your employees tend to their mental health.

Friday Stats and More

David Ermer–CDC, COVID-19, COVID-19 vaccine, Federal employment benefits, Rx coverage, U.S. Healthcare–

Based on the Centers for Disease Control’s COVID-19 Data Tracker website, here is the FEHBlog’s chart of new weekly COVID-19 cases and deaths over the 14th week of 2020 through 34th week of this year (beginning April 2, 2020, and ending August 25, 2021; using Thursday as the first day of the week in order to facilitate this weekly update):

and here is the CDC’s latest overall weekly hospitalization rate chart for COVID-19:

The FEHBlog has noticed that the new cases and deaths chart shows a flat line for new weekly deaths  because new cases significantly exceed new deaths. Accordingly here is a chart of new COVID-19 deaths over the period (April 2, 2020, through August 25, 2021):

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through August 25, 2021, which also uses Thursday as the first day of the week:

The cases, hospitalizations, and death charts move continue to move in the wrong direction. New vaccinations remain steady as people recognize that the Delta variant is more aggressive than the 2020 wave. If there is any bright side it is that the elderly (age 65 and older) who are at the greatest risk of death from COVID-19 are the most vaccinated group in the U.S. with 81.5% fully vaccinated and another 10% at the first dose stage.

For more stats, here’s a link to the CDC’s weekly interpretative review. “As of August 26, 2021, 203 million people in the United States have received at least one dose of a COVID-19 vaccine. 172 million people are fully vaccinated. That’s 60.8% of the eligible population (12 years and older). * * * COVID-19 vaccines remain the most powerful tool we have against COVID-19, making it critical that all people get vaccinated as soon as they are eligible. To find a vaccine provider near you, visit vaccines.gov or your state or local public health department.”

The CDC also issued its 2021-22 flu season vaccination recommendations today.

Routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have contraindications. * * * Balancing considerations regarding the unpredictability of timing of onset of the influenza season and concerns that vaccine-induced immunity might wane over the course of a season, particularly for older adults, vaccination is recommended to be offered by the end of October. * * * Children aged 6 months through 8 years who require 2 doses (i.e., children in this age group who have never received influenza vaccine or who have not previously received a lifetime total of ≥2 doses; see Children Aged 6 Months Through 8 Years) should receive their first dose as soon as possible after the vaccine becomes available to allow the second dose (which must be administered ≥4 weeks later) to be received, ideally, by the end of October. Children of any age who require only 1 dose for the season should also ideally be vaccinated by the end of October; vaccination of these children may occur as soon as vaccine is available because there is less evidence to suggest that early vaccination is associated with waning immunity among children compared with adults.

Also from the Delta variant front

  • The Numbers columnist in the Wall Street Journal reports that “Medical studies often use thousands of volunteers. But sometimes good things come in small packages—like a handful of people willing to contract a deadly virus. Researchers in the U.K. have deliberately infected 30 volunteers with the virus that causes Covid-19, in the first human challenge study of the disease. Infecting the volunteers—who are healthy, unvaccinated and range in age from 18 to 30—will allow the scientists to observe in real time how the virus attacks the body and, from the moment of exposure, how the immune system responds. * * * [In contrast to a large clinical study involving the use of placebo] a human challenge study of a relatively small number of participants offers precise answers to specific questions, often related to immune response. Today, human challenges conducted under the supervision of institutional review boards are routinely used to research diseases such as influenza, malaria, cholera, salmonella, shigellosis and norovirus.”
  • The Journal also reports that British scientists are making progress in carefully growing the Delta variant for use in these human challenges. The U.S. is not conducting human challenges involving COVID-19 at this time.
  • The Journal also informs us that “U.S. intelligence agencies are unable to determine conclusively how the Covid-19 pandemic emerged, a summary of a classified report released Friday said.” The article concludes “In a July 27 letter to Mr. Biden, the Democratic and Republican leaders of the Senator Foreign Relations and Intelligence committees urged the president to carry on with the investigation until the intelligence community had reached conclusions on the origin of the pandemic with a high degree of confidence. The letter urged that the inquiry examine what U.S. government funding was provided to the Wuhan Institute of Virology for advanced virus research.”

In other news —

  • The Federal Times reports that “Federal employees will get a total 2.7 percent pay raise in 2022, as President Joe Biden informed Congress Aug. 27 that he intends to exercise his authority to determine federal pay rates during a state of emergency.” The increase will breaks down into a 2.2% general increase and a 0.5% locality pay increase.
  • Fierce Healthcare tells us that “OptumRx has released its quarterly look at the drug pipeline, and two of the therapies highlighted in the report target fairly common conditions. Finerenone, or the brand name Kerendia, was approved by the Food and Drug Administration on July 9. The drug treats chronic kidney disease and type 2 diabetes. Some 26.8 million Americans have been diagnosed with diabetes, and one in three eventually develop some kind of kidney disease. Bill Dreitlein, senior director of pipeline and drug surveillance at OptumRx, told Fierce Healthcare that the drug will be entering a market where many patients are already treated by low-cost therapies. “With the entrance of this drug, some patients are going to shift from a low-cost treatment to a higher-cost treatment,” he said. The other drugs highlighted in the report are: (1) Atogepant, which is pending a brand name, a drug that treats episodic and chronic migraines; (2) Odevixibat, or the brand name Bylvay, which treats progressive familial intrahepatic cholestasis, a liver disease, and (3) Maralixibat, which also has yet to set a brand name, treats Alagille Syndrome, a rare genetic disease of the liver.
  • Healthcare Dive informs us that “COVID-19 hospitalizations continue to rise as coronavirus cases surge across the U.S. This once again puts pressure on hospital operations and will likely put downward pressure on nonprofit hospital margins, according to a new report from Fitch Ratings. In some areas, hospitalizations are higher than they were during previous surges.”

Tuesday’s Tidbits

David Ermer–AHRQ, Congress, COVID-19, COVID-19 vaccine, OPM, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Capitol Hill, the Wall Street Journal reports that “Top House Democrats said the chamber would move forward with voting on the budget blueprint for a $3.5 trillion healthcare, education and climate package next week, rebuffing demands from a group of centrist Democrats to first vote on a $1 trillion infrastructure bill and urging their caucus to stay unified around President Biden’s agenda” According to the article the centrist Democrats opposed the Speaker’s compromise approach discussed in Sunday’s Post and the much larger Democrat progressive causus pushed hard for this outcome. Speaker Pelosi can only afford to lose three of the nine Democrat centrists as the Republicans are expected to unanimously oppose the budget blueprint.

From the Delta variant front

  • Bloomberg reports that the Southern states continue to experience robust vaccination rates one month after the mid-July low point.
  • The Wall Street Journal informs us that “The Delta variant of the Covid-19 virus appears to be breaking through the protection vaccines provide at a higher rate than previous strains, a Wall Street Journal analysis found, though infections among the fully inoculated remain a tiny fraction of overall cases, and symptoms tend to be milder.”
  • Most significantly the New York Times reports tonight that

The Biden administration has decided that most Americans should get a coronavirus booster vaccination eight months after they received their second shot, and could begin offering third shots as early as the third week of September, according to administration officials familiar with the discussions.

Officials are planning to announce the decision on Wednesday at the White House. Their goal is to let Americans who received the Pfizer-BioNTech or Moderna vaccines know now that they will need additional protection against the Delta variant, which is causing caseloads to surge across much of the nation. But the new policy will depend on the Food and Drug Administration authorizing additional shots.

Recipients of the Johnson & Johnson vaccine, which was authorized as a one-dose regimen, will also most likely require an additional dose, the officials said. But they are waiting for results, expected this month, from a clinical trial that provided participants with two doses. So far, only about 14 million people in the United States have gotten the Johnson & Johnson shot, which the government began offering in March. The first Pfizer and Moderna vaccines were given in December.

The first boosters would probably go to nursing home residents, health care workers and emergency workers, who were the first to be vaccinated last winter. They would likely be followed by other older people, then by the general population. Officials envision giving people the same vaccine they originally received.

On the federal employment front, Federal News Network tells us that OPM is promulgating an interim final rule that will allow agencies to “hire [bachelors degree or graduate] students to a temporary appointment of a year or a term appointment of one-to-four years. Students will work for their agency at the General Schedule 11 level or below while in school. Students who finish their degrees and meet a series of other requirements are eligible for a permanent position at the same agency, OPM said.”

From the federal guidance front

  • The National Law Review informs us that “OSHA’s Revised COVID-19 Guidance [released August 13] Adopts CDC’s Latest Recommendation on Masks for Vaccinated Employees, Advocates for Vaccination, and Suggests Periodic Testing for Unvaccinated Employees.” “Although OSHA disclaims that its recommendations are legally binding on employers, the agency also includes language that signals that failure to adhere to the recommendations could be legally significant for the employer.  Specifically, OSHA prefaces its guidance by stating: “The recommendations are advisory in nature and informational in content and are intended to assist employers in providing a safe and healthful workplace free from recognized hazards that are causing or likely to cause death or serious physical harm.”
  • The tri-agencies issued Affordable Care Act FAQ 48 informing interested parties that in response to litigation they are working on an amending the “2018 final regulations that expanded exemptions for entities with religious or moral objections to the contraceptive coverage requirement to which their health plans would otherwise be subject.” That rulemaking of course will lead to more litigation and so on.

On the drug news front, STAT News reports that

A new study found that the number of adults who used two widely prescribed stimulants nearly doubled in recent years, raising concerns about a potential wave of abuse since both medicines can be highly addictive.

Specifically, an estimated 4.1 million adults reported using amphetamines and methylphenidate in 2018, an increase of nearly 80% from 2013. Measured by total prescriptions, the use of amphetamines rose 119% during that time, while the use of methylphenidate grew about 39%, according to the study, which was published in BMJ Open.

The article warns that this surge could turn into another epidemic.

On the healthcare utilization front, Fierce Healthcare reports that

Hospitals did not experience a major rebound in deferred care in the first part of 2021, foretelling that such care may not be coming back, a new analysis finds.

The analysis from Kaiser Family Foundation and the Epic Health Research Network, released Tuesday, found hospital spending was 4.1% below expected levels in June. It is the latest evidence of how the lingering impact of the pandemic could affect hospital finances, especially as the highly transmissible delta variant is causing new surges in most states.

“Several factors may be contributing to the lower-than-expected number of hospital admissions in early 2021,” the analysis said. “For example, the economic effects of the pandemic may depress the number of people seeking services.”

Researchers explored data from 250 hospitals across 47 states and 112 million patients through April 9, 2021.

Hospital admission rates were nearly 90% of what were expected if the pandemic did not happen, the analysis found.

From the tidbits department

  • Health Day tells us that “A small, new study suggests that getting out of your chair every half hour may help improve your blood sugar levels and your overall health.”
  • Fierce Healthcare informs us that “New York City-based Unite Us announced this morning [August 17] the acquisition of Carrot Health, a consumer data and predictive analytics platform offering engagement insights to payer and provider customers. With its new purchase, the social determinants of health software platform said it will be better positioned to help healthcare organizations identify patients with unmet social needs and connect them to community resources across all 50 states. Unite Us did not disclose the terms of the deal, which has already closed.”
  • In this week’s NIH Director’s blog, Dr. Francis Collins discusses how advanced brain scanning can help guide neurosurgeons.
  • Last but certainly not least the HHS Agency for Healthcare Quality and Research issued a call to action on achieving health equity.

Thursday Miscellany

David Ermer–COVID-19, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

Govexec reports that

The Veterans Affairs Department will more than triple the number of employees who must receive the vaccine, bringing the total to 360,000. VA originally required just its frontline health care staff—those hired under Title 38 of the U.S. Code—to be inoculated, which amounted to about 115,000 workers. 

The mandate will now include Title Five employees within the Veterans Health Administration—such as housekeepers, engineers and administrative staff—and health care providers such as psychologists, pharmacists, physical therapists, nursing assistants and others in “Hybrid Title 38” positions. 

“We’re now including most VHA employees and volunteers and contractors in the vaccine mandate because it remains the best way to keep veterans safe, especially as the Delta variant spreads across the country,” Secretary Denis McDonough said. “This pandemic is not over and VA must do everything in our power to protect veterans from COVID-19. With this expanded mandate, we can once again make—and keep—that fundamental promise.”

Employees impacted by the new mandate will have eight weeks to get the vaccine or prove they already have.

In the same vein, the Department of Health and Human Services (“HHS”) announced today that

[HHS] will require more than 25,000 members of its health care workforce to be vaccinated against COVID-19.

Staff at the Indian Health Service (IHS) and National Institutes of Health (NIH) who serve in federally-operated health care and clinical research facilities and interact with, or have the potential to come into contact with, patients will be required to receive the COVID-19 vaccine. This includes employees, contractors, trainees, and volunteers whose duties put them in contact or potential contact with patients at an HHS medical or clinical research facility.

Additionally, U.S. Surgeon General Dr. Vivek Murthy will immediately require members of the U.S. Public Health Service Commissioned Corps to be vaccinated against COVID-19 as part of medical readiness procedures to prepare for any potential deployment need as emergency responders

Those two mandates apply to about 20% of the federal workforce. In contrast, the general approach is a vaccine screening requirement — either attest to receiving the vaccine or wear a facemask and receive regular COVID-19 testing.

Furthermore, the Wall Street Journal reports that

The U.S. Food and Drug Administration authorized booster shots for certain people with weakened immune systems, likely the launch of broader efforts to better protect against evasive variants like Delta.

The agency on Thursday cleared giving a third dose of a messenger RNA Covid-19 vaccine from Pfizer Inc. PFE 2.01% and its partner BioNTech SE BNTX 4.13% or from Moderna Inc. MRNA 1.58% to immunocompromised people who had received a solid organ transplant or individuals who have been diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

From the health equity front, the National Institutes of Health released a disturbing study on maternal mortality:

Racial and ethnic disparities in maternal mortality — deaths related to pregnancy or childbirth — in the United States may be larger than previously reported, suggests a study funded by the National Institutes of Health. By re-examining information on death certificates from 2016 and 2017, researchers found that the maternal mortality rate among non-Hispanic Black women was 3.5 times higher than among non-Hispanic white women. Previously, standard analyses had indicated a 2.5-times-higher death rate for Black women.

The new analysis also revealed that these disparities were concentrated among a few causes of death. Postpartum cardiomyopathy (disease of the heart muscle) and the blood pressure disorders preeclampsia and eclampsia were leading causes of maternal death for Black women, with mortality rates five times higher than those for white women. Pregnant and postpartum Black women were two to three times more likely than white women to die of hemorrhage (severe bleeding) or embolisms (blood vessel blockages).

The study was funded by NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and led by Marian MacDorman, Ph.D., of the Maryland Population Research Center at the University of Maryland. It appears in the American Journal of Public Health.

Healthcare Dive reports on HIMSS conference presentations on this important topic of achieving health equity.

Healthcare executives do say equity is a top priority for their organizations, with half of the CEOs surveyed by Deliotte early this year saying its among their top three organizational priorities this year, according to a recent report from the consultancy.

However, companies are at different stages of actually implementing equity and inclusion programs, with some reporting they’ve been focused on addressing disparities for years, and others just beginning to define what it means to their organization.

Of the 20 chief executives surveyed by Deliotte, 17 said they had a dedicated team or budget for health equity initiatives.

That top-level buy-in is important, but addressing health inequities needs to be a whole-enterprise mission, [Ronald] Copeland[, the chief equity, inclusion and diversity officer for integrated health giant Kaiser Permanente] said, integrated into every facet of payer and provider goals. One strategy to achieve this could be to make health equity a formal dimension of quality improvement, a policy that’s even recently been considered in federal payer programs under the Biden administration.

In other HIMSS conference news —

  • Fierce Healthcare informs about HIMSS conference discussion on rationalizing patient and provider experiences with multiple front end apps.
  • Healthcare Dive interviews Teladoc’s president of hospitals and health systems, Joe DeVivo about the state of the telehealth market and the company’s ambitions.

STAT News informed us today that 19,000 people attended the HIMSS conference in person and 5,000 attended virtually. 700 exhibitors attended. Both of those totals are about half of the normal in person attendance at HIMSS.

From the drug costs front, the White House released the President’s ideas on how to reduce prescription drug costs. The President leads off with encouraging Congress to allow CMS to negotiate Medicare Part D drug contracts. That change may save money for the federal government but it shift those savings to the commercial sector including the FEHB.

Also the HHS Inspector General released a report on opioid use among Medicare beneficiaries in 2020. “More than 43,000 Medicare Part D beneficiaries suffered an opioid overdose—from prescription opioids, illicit opioids, or both—in 2020.” The Inspector General also noticed a drop in prescriptions for opioid treatments which the OIG found concerning. “A May 2020 OIG data brief recommended that CMS educate Part D beneficiaries and providers about access to MAT drugs and naloxone. We continue to encourage CMS to take these steps. It is also critical for CMS to closely monitor the number of beneficiaries receiving MAT drugs and naloxone and take action, if needed. OIG is also committed to continuing our work on opioid use and access to treatment.”

In litigation news, the prescription benefit manager trade association, PCMA, has filed a lawsuit against HHS in the District of Columbia’s federal court challenging the legality of certain aspects of the payer transparency rule scheduled to start phasing in on January 1, 2022.

PCMA is not challenging the portions of the rule that direct plans to provide useful information directly to patients. But we are challenging the portions of the rule that do not meet those important objectives and will not produce information that patients and physicians can use.

These parts of the Trump administration’s transparency rule will drive prescription drug costs higher. By requiring disclosure of “historical” net prices, which are essentially current year net prescription drug prices, the rule will directly provide drug manufacturers access to their competitors’ negotiated rebates, discounts, and price concessions. This in turn will allow drug manufacturers to discount less deeply as they realize their price concessions went beyond those of competitors.

In addition, outside entities will not be able to develop reported information into a useful and understandable format for patients. Unlike health plans and PBMs, third-party application developers will not know patients’ existing insurance enrollment and eligibility or their current benefits and whether they have met a deductible or reached an out-of-pocket limit, and so the third-party applications are likely to cause widespread confusion among patients. Net prices are generally not useful information to patients because their deductible and coinsurance payments are calculated based on negotiated rates, not net prices.

PBMs and health plans already have real-time benefits tools for patients and prescribers, which they can use at the point of prescribing to check on cost-sharing for every patient based on their individual situation and health plan.

Coincidentally, the U.S. Chamber of Commerce has filed a substantially similar lawsuit in the federal court for the Eastern District of Texas. That case challenges the legality of the “historical net prices” provision and the “three machine readable tapes” provision of the HHS rule on the ground that they have no utility to consumers. Good luck.

Finally, the Census Bureau released a lot more 2020 census data today. The Wall Street Journal observes that “The nation’s population grew just 7.4% during the decade, the second slowest on record for a decennial census. Only the 1930s—the era of the Great Depression—saw slower growth.”