Monday Roundup

COVID-19 vaccine

Monday Roundup

David Ermer–ACA, COVID-19, COVID-19 testing, COVID-19 vaccine, No Surprises Act, Rx coverage–
Photo by Sven Read on Unsplash

From the Omicron front, the Wall Street Journal reports that

The seven-day average of daily reported Covid-19 cases in the U.S. reached a pandemic record 403,385 on Sunday, according to a Wall Street Journal analysis of Johns Hopkins University data. The fresh peak arrived even as most states paused reporting during the New Year’s holiday weekend. Reporting delays will likely lead to spikes in reports of cases this week as states catch up. While Covid-19 tests remain in short supply in much of the U.S., Covid-19 testing was less robust last year, complicating comparisons between pandemic surges.

Hospitalizations for confirmed or suspected Covid-19 reached a seven-day average of 97,855 on Monday, according to data posted by the U.S. Department of Health & Human Services. That is up 41% in the past two weeks but below both the pandemic peak of 137,510 on Jan. 10, 2021, and the smaller peak of 102,967 on Sept. 4, 2021, during the Delta surge.

Bloomberg adds that

While omicron may be good at evading the attacks of antibodies, recent studies have also shown that it has far less success avoiding the second-line defenses of vaccines and prior infections: T-cells and B-cells.

T-cells are responsible for attacking a virus once it makes its way into the body’s cells if antibodies fail to prevent infection in the first place. In a recent study by Burgers and colleagues, scientists used white blood cells from Covid patients to show that about 70-80% of the T-cell response is preserved compared with previous strains of the virus. That means that for those who are either vaccinated or had a Covid infection in the past 6 months, it is likely their T-cells can recognize omicron and fight it off relatively quickly. 

This latest research will need to be followed up with further study. If it holds up to additional scrutiny, it just might explain why current infections appear to be more mild than in previous waves of the virus.

Yet, AP reports that

As the COVID-19 omicron variant surges across the United States, top federal health officials are looking to add a negative test along with its five-day isolation restrictions for asymptomatic Americans who catch the coronavirus, the White House’s top medical adviser said Sunday.

Dr. Anthony Fauci said the Centers for Disease Control and Prevention is now considering including the negative test as part of its guidance after getting significant “pushback” on its updated recommendations last week.

Adding to current mandatory testing is not going to push the COVID ball further toward endemic status particularly when people who actually may be infected soon will need a test to gain access to a COVID pill. It is time for the government to rethink its testing strategy. As a physician explained in a thought provoking Atlantic article

I will admit to being as self-interested as any other human. Despite recognizing the need for vaccine and test equity, I received three Pfizer shots as soon as I was eligible, and I’ve kept a stash of rapid-detection kits in my closet. But my own cognitive dissonance, and that of other privileged people, has become untenable in the face of Omicron’s case surge. Given the reality of our testing shortages, it’s time we started cutting back, where and when we can.

From the COVID vaccine front, AHIP tells us that

“Today the Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to expand the use of a single booster dose of the vaccine to include its use in individuals as young as 12 years of age.

“The FDA reviewed real-world data from Israel, including safety data from more than 6,300 individuals 12 through 15 years of age who received a booster dose of the vaccine at least 5 months following completion of the primary two-dose vaccination series. The data shows there are no new safety concerns following a booster in this population. There were no new cases of myocarditis or pericarditis reported to date in these individuals.

“The amended EUA additionally:

  • Decreases the time between the completion of primary vaccination of the Pfizer COVID-19 Vaccine and a booster dose to at least five months.
  • Allows for a third primary series dose for certain immunocompromised children 5 through 11 years of age.

“Peer-reviewed data from multiple laboratories indicate that a booster dose of the Pfizer COVID-19 Vaccine greatly improves an individual’s antibody response to be able to counter the omicron variant. Authorizing booster vaccination to take place at five months rather than six months may therefore provide better protection sooner for individuals against the highly transmissible omicron variant.

“Children 5 through 11 years of age who are fully vaccinated and are not immunocompromised do not need a third dose at this time, but the FDA will continue to review information and communicate with the public if data emerges suggesting booster doses are needed for this pediatric population.”

From the Health and Human Services Department front —

  • Prof. Katie Keith has published in the Health Affairs Forefront the third installment of her review of the proposed 2023 Notice of Benefit and Payment Parameters. This one focuses on the Affordable Care Act’s risk adjustment provisions.
  • The Department issued today its own upbeat discussion of the recently implemented consumer billing protections provided by the No Surprises Act.
  • While the ACA risk adjustment provisions don’t apply the FEHB, the consumer billing protections do. Indeed the consumer billing protections wisely apply to both insured and uninsured folks. All consumers should become familiar with these protections.

From the prescription drug front, STAT News informs us that

As 2022 gets under way, pharmaceutical companies have so far raised wholesale prices by a median of 4.9% on more than 450 prescription medicines, an overall annual increase that is comparable to the price hikes seen over the past three years, according to a new analysis.

The numbers are preliminary, though, because still more price increases are expected to be disclosed by drug makers later this month, since not every company has reported their latest prices to industry databases. Nonetheless, the early indication is that many drug makers are keeping price hikes in check due to ongoing bad publicity that has sparked sustained political pressure.

Analyzing pharmaceutical price hikes has become a ritual each January as drug makers boost prices to meet financial goals. But as poll after poll finds more Americans are complaining about the cost of prescription medicines, these companies have gradually shied away from mid-year increases and also generally limited price hikes below double digits in hopes of avoiding still more negative headlines.

Drug Channels adds

Reality has again failed to cooperate with the politically motivated cries of “skyrocketing drug prices” or anecdotes about companies “jacking up prices” 

Brand-name drug prices continue to decline, while the prices of other healthcare products and services continue to rise. For 2021, brand-name drugs’ net prices dropped for the fourth consecutive year. Meanwhile, brand-name drug list prices grew more slowly than overall inflation. What’s more, we project that the gross-to-net bubble for patent-protected brand-name drugs will exceed $200 billion in 2021. See our updated analysis [that may be found in the linked article]. 

The factors that drive declining brand-name drug prices remain for 2022, suggesting that these trends will continue. 

Thursday Stats and More

David Ermer–ACA, AHRQ, CDC, COVID-19, COVID-19 vaccine, No Surprises Act–

Based on the CDC’s COVID Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s final weekly calendar for 2021 and it’s a stunner:

STAT News features a timely article captioned “Beyond Case Counts: What Omicron is teaching us.”

Brace yourself: Case counts are going to reach astounding heights. Already, reported infections have doubled in just a few weeks. The average daily number of infections is greater than 300,000. (It’s likely that our case counts will become increasingly less reliable as well, given both the shortcomings of our testing infrastructure and the growing use of at-home tests.)  

But, in large part because the immunological landscape today is far different than what it was two years ago, cases are less likely to result in severe disease than was the case at the start of the pandemic. 

Back then, a rise in cases inevitably led to an increase in hospitalizations and deaths. When vaccines went into wide use, those metrics started to become decoupled; cases could rise sharply but hospitalizations and deaths occurred at a lower level than before. In the current phase of the pandemic, the distance between those metrics is growing even greater. * * *

[A] key question relates to how long we’ll be in Omicron’s grasp. South Africa’s bellwether wave soared to extraordinary heights — then quickly began to ebb. Data from several European countries also suggest that Omicron waves may be short, sharp shocks compared to the waves that have preceded it. But too little is yet known to predict with any confidence whether the experience of a country with a relatively young population, such as South Africa, will hold true in a country with an older population, such as the United States. 

Here’s a link to the FEHBlog’s final weekly chart of new COVID deaths:

As cases have skyrocketed, deaths have ranged between 5,000 and 10,000 per week for over four months.

Here’s the FEHBlog’s weekly chart of new COVID vaccinations administered and distributed from the 51st week of 2020, when the vaccinations became available to the public, and the 52nd week of 2021:

The number of administered COVID vaccines has dropped during the holidays. Currently, 72.8% of Americans aged 18 and older are fully vaccinated and 36.3% of that cadre are boostered. Nearly 50% of Americans aged 50 and older are boostered.

Also from the COVID vaccine front, the Hill reports that

The Food and Drug Administration (FDA) is expected to approve booster shots of Pfizer and BioNTech’s COVID-19 vaccine for 12- to 15-year-olds on Monday, people familiar with the agency’s plan told The New York Times.

In addition to that broadened policy, the FDA also intends to announce that both children and adults could seek their booster shot five months after their second dose, instead of the previously advised six months. Immunocompromised children ages 5 to 11 are also expected to be allowed boosters, according to the Times.

The Times reported that the vaccine advisory committee for the Centers for Disease Control and Prevention (CDC) is set to meet next week to vote on approving the FDA’s policy changes, which CDC Director Rochelle Walensky is expected to endorse. 

From the No Surprises Act front, CMS has released a handy, comprehensive overview of the federal independent review process. Check it out.

From the Affordable Care Act front, Prof. Katie Keith writing in Health Affairs Forefront has released two of three articles on the ACA 2023 Notice of Benefit and Payment Parameters released earlier this week — link to Part 1 and link to Part 2. Part 1 includes a discussion of proposed changes to the medical loss ratio calculation and Part 2 discusses the standardized benefit requirements that the FEHB mentioned earlier this week.

From the health disparity front, the Agency for Healthcare Research and Quality issued its 2021 report on national healthcare qualities and disparities, the nineteen report in this series. Here’s a link to the report’s executive summary.

From the New Year’s Eve front, the New York Times made available this guidance:

“Many public health experts agree that you can celebrate with your favorite people as long as you’re taking precautions.
“To help you make a decision and gauge the level of risk, The Times has this quiz.”

Midweek update

David Ermer–ACA, CDC, COVID vaccine mandate, COVID-19, COVID-19 testing, COVID-19 vaccine, Patient safety, U.S. Healthcare–

From the Omicron front, the Washington Post reports that breakthrough Omicron cases are becoming the new normal in the U.S.

Long-anticipated holiday plans fell apart as people — young and old, vaccinated and unvaccinated — tested positive right and left. Those with negative tests worried it was only a matter of time.

They are likely right, according to Robert Frenck, professor of pediatrics and director of the Vaccine Research Center at the Cincinnati Children’s Hospital. “You know what? You’re probably going to get covid,” he said, but if you have been vaccinated you are unlikely to become seriously ill.

Oddly, in the FEHBlog’s view, the article does not mention the additional natural immunity gained from a mild case of Omicron.

STAT News raises three “big” questions about the Biden administration’s Covid response in 2022 —

1. Will the government broaden its focus beyond vaccines? STAT News explains that

Even before there were Covid-19 vaccines, there were commonsense tools used to prevent the disease from spreading: Wearing masks, and avoiding indoor gatherings with large numbers of other people.

But two years into the pandemic, the U.S. is still laser-focused on vaccines, and has largely ignored other factors. In particular, federal regulators haven’t done much to incentivize Americans to wear higher-quality face coverings, or to maintain better filtration and cleaner air in indoor spaces.

On the bright side, the FDA approved two new rapid over the counter COVID tests today on an emergency use basis. The more the merrier.

2. Will people who feel sick have better options for tests and treatments? STAT News explains rapid COVID tests are short in supply and pricey and the Biden Administration’s government solutions won’t be implemented for weeks. Similarly we have two exciting COVID pills which won’t be widely available for months.

3. Forget a third vaccine dose — will Americans need a fourth, too? To the FEHBlog that seems like a foregone conclusion.

From our other epidemic front, MedPage Today reports that

The volume of opioids dispensed from retail pharmacies fell by about 21% from 2008-2009 to 2017-2018, but cuts were not uniform, national prescription records showed.

Changes in opioid prescribing varied substantially by county, patient, and prescriber, reported Bradley Stein, MD, PhD, of the RAND Corporation in Pittsburgh, and co-authors in Annals of Internal Medicine. * * *

Per-capita morphine milligram equivalents (MMEs) fell by 22.6% in metropolitan counties and by 34.6% in counties with the highest rates of fatal opioid overdoses, the researchers found. In multiple counties, opioid prescribing increased over time. Some states had counties with both increases and substantial decreases, and these counties often were next to each other.

People 18 to 25 years old experienced the sharpest decrease in prescription opioids (66.6%) per capita, followed by those 26 to 35 (57%). Patients 56 to 65 had essentially no change (0.1% decline), while those 66 and older had a 12% drop.

People covered by commercial insurance had a 41.5% decline per capita. Those with Medicaid had a 27.7% reduction, and those with Medicare had a 17.5% drop.

MMEs plummeted by 70.5% among emergency physicians, even though these doctors are likely to prescribe opioids predominantly to people with acute pain, the researchers noted. The top two opioid prescribers, primary care physicians and pain specialists, also saw reductions in MMEs of 40% and 15.4%, respectively. MMEs fell by 49.3% among surgeons and by 59.5% among oncologists.

From the COVID vaccine mandate front, the Eleventh Circuit U.S. Court of Appeals which is hearing a challenge to a nationwide stay of the government contractor mandate (Case No.  21-14269), decided yesterday not to hear the case before the entire court rather than a three judge panel and today to decline the government’s request to accelerate the briefing and argument calendar. Consequently the stay will remain in effect at least through January 2022.

From the Federal Register front, the Department of Health and Human Services finalized its rescission of the Trump Administration’s most favored nation drug pricing rule. Smart move.

Thursday Stats and More

David Ermer–ACA, CDC, COVID treatment, COVID-19, COVID-19 vaccine, No Surprises Act–

Happy Festivus, dear readers. Because the FEHBlog won’t be posting on Christmas Eve or Christmas Day, he has moved up the COVID Stats report to today’s post. Therefore, the FEHBlog also wishes you a Merry Christmas

Based on the Centers for Disease Control’s COVID Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s latest weekly chart of new COVID cases for 2021:

Bloomberg notes that

The omicron variant’s case rate has now exceeded the worst days of the first delta-fueled wave, and more cities and countries are imposing precautions. But there’s more research showing it to be less severe than previous mutations. That said, two doses and a booster of the vaccine most widely used around the world isn’t enough to fight off omicron. China’s Sinovac shot didn’t produce sufficient levels of neutralizing antibodies, research found. Another study however showed a third dose of AstraZeneca’s vaccine, like that of Moderna and Pfizer-BioNTech, significantly boosts protection against the variant. 

Here’s the FEHBlog’s weekly chart of new COVID deaths which has operated within the same range for the past three months:

Finally, here’s the FEHBlog’s weekly chart of new COVID vaccinations distributed and administered from the 51st week of 2020 through the 51st week of 2021:

The number of COVID vaccines, including boosters, topped 500,000,000 today according to the CDC. 71% of Americans aged 12 and older are fully vaccinated and over one third of Americans aged 18 and older are boostered.

David Leonhardt in his New York Times’ Morning column offers an array of convincing statistics showing the importance of being fully vaccinated and boostered against COVID.

STAT News reports that

The Food and Drug Administration on Thursday granted emergency authorization to Merck’s molnupiravir, an antiviral pill shown to reduce hospitalization and death in cases of Covid-19, but only in cases where other FDA-authorized Covid treatments are not accessible or clinically appropriate.

The approval comes a day after the FDA authorized an antiviral pill from Pfizer for much broader use in patients as young as 12. 

“Today’s authorization provides an additional treatment option against the COVID-19 virus in the form of a pill that can be taken orally. Molnupiravir is limited to situations where other FDA-authorized treatments for COVID-19 are inaccessible or are not clinically appropriate and will be a useful treatment option for some patients with COVID-19 at high risk of hospitalization or death,” Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

A Merck spokesperson said Merck is ready to ship hundreds of thousands of courses of treatment within days of authorization and 1 million courses over the next few weeks in the U.S. Ten million courses are ready to be packaged and distributed worldwide.

Bloomberg adds its perspective on the FDA’s EUAs of COVID pills yesterday and today.

The U.S. has cleared its first two Covid-19 treatment pills. Now comes the hard part: deciding who should get one. Merck’s molnupiravir was authorized Thursday by the Food and Drug Administration for use in some infected adults at high risk of severe illness. The U.S. will soon have 3 million courses of it available. Meanwhile, Pfizer’s Paxlovid, authorized earlier this week, showed stronger clinical trial data. But it will only be available in limited quantities at first, as Pfizer takes months to ramp up manufacturing. Regulators are signaling they prefer Pfizer’s pill, but concede Merck’s drug is better than nothing. Regardless, availability may depend on which state you live in. —David E. Rovella

In the linked article Bloomberg explains that

Just like Covid-19 testing sites and vaccines, Covid-19 treatment pills will be in short supply for months until production can increase.

The federal distribution to states will be based on population, and it will likely be up to doctors to prescribe Pfizer Inc.’s Paxlovid. The National Institutes of Health said it will release recommendations on how to allocate treatments.* * *

“Product will be limited at first and ramp up significantly in the coming months,” the department [of Health and Human Services] said. “An initial 65,000 courses of Paxlovid will be made available for shipment to states and territories and will begin arriving at dispensing sites by the end of December.”

The U.S. will have 265,000 Pfizer courses by the end of January and 10 million courses by July. It will also have 3 million of Merck & Co.’s Covid pill, developed with partner Ridgeback Biotherapeutics LP, by the end of January.

Doctors will be looking for the Merck and Pfizer pills to fill a gap for high-risk patients, who until now have been treated with monoclonal antibody therapies to keep them from needing hospital care.

Some of the most widely used antibody treatments from Eli Lilly & Co. and Regeneron Pharmaceuticals Inc. appear far less effective against omicron than earlier variants because they target regions on the virus’s spike protein that have changed during its evolution.

In No Surprises Act (“NSA”) news —

  • The Centers for Medicare and Medicaid Services released FAQS for out-of-network providers who may be impacted by the NSA which takes effect on January 1, 2022.
  • The FEHBlog has been looking more deeply into the federal independent dispute resolution (“IDR”) process under this law. The IDR process allows an out-of-network provider with claims subject to the NSA to negotiate its payment with the health plan and if unsatisfied bring the payment issue to baseball arbitration using a CMS approved arbitrator. CMS has posted a list of the five currently approved organizations certified to conduct IDR arbitrations. The FEHBlog checked out a couple of these organizations and found out that at least two of them also are CMS approved independent review organizations (“IRO”) which decide health plan claim disputes under the Affordable Care Act. (In the FEHBP OPM acts as the IRO.)
  • The FEHBlog also learned that out-of-network providers who obtain patient consent to waive their NSA rights cannot access the IDR process on that consenting patient’s claims. Health plans will need to be on the lookout for the provider’s notice that the NSA rights waiver has been accepted by the patient / plan member. Here is a link to the consent form. In these cases which the FEHBlog expects to be relative few in number, the plan would pay the out-of-network provider using the ACA emergency care rules or the plan allowance for non-emergency services.
  • Generally only providers, e.g., primary surgeon, lead oncologist, who manage the patient’s care can seek patient consent to waive NSA rights. Ancillary providers, e.g., anesthesiologists, radiologist, pathologists, hospitalists, are locked into using the IDR process. This was a sound decision by the ACA regulators. Kaiser Family Foundation offers a useful compendium of these rules.
  • What’s more, Thompson Reuters reports that

HHS has released instructions for reporting data under a transparency provision included in the Consolidated Appropriations Act, 2021 (CAA , Division BB, Section 204), which requires group health plans and insurers to annually report prescription drug and health care spending, premiums, and enrollment information to the government

OPM has required FEHB carriers to comply with this reporting requirement via OPM’s reporting authority under the FEHB Act, 5 U.S.C. Sec. 8910. This strikes the FEHBlog as a bit of a stretch as Congress did not apply NSA Section 204 to the FEHBP in the NSA law and Section 8910 contemplates carriers providing reports to OPM. When FEHB carriers find themselves obligated to submit reports to HHS, a separate law outside the FEHB Act vests that authority in the other agency, e.g., Section 111 Medicare eligibility reporting to CMS. In any event, the enforcement deadline for the 2020 and 2021 reference year reporting under Section 204 is December 27, 2022.

Midweek Update / At Last a COVID Pill!

David Ermer–ACA, CDC, COVID treatment, COVID vaccine mandate, COVID-19, COVID-19 vaccine, Federal employment benefits, OPM, U.S. Healthcare–

From the Omicron front, STAT News reports that

The Food and Drug Administration on Wednesday authorized Paxlovid, a pill developed and made by Pfizer, as a treatment for Covid-19, a significant step in the battle against the SARS-CoV-2 virus.

The drug was authorized for use in people as young as 12 so long as they weigh at least 88 pounds.

The authorization of an oral antiviral to beat back Covid has been eagerly anticipated because such a medicine could reach large numbers of people infected with the virus and prevent them from becoming seriously ill or hospitalized. Existing medicines, such as monoclonal antibodies, must be given intravenously or as injections.

Still, initial supplies of Paxlovid will be limited. Pfizer has said it expects to produce more than 180,000 courses of the treatment this year. The company said Wednesday it now expects to provide 120 million courses by the end of 2022, up from 80 million previously, thanks in part to new contract manufacturers. Pfizer has contracted with the U.S. government to provide 10 million courses by the end of 2022 at a cost of $5.29 billion.

Once readily available, Paxlovid will be the answer to a positive COVID test, rather than 10 days of quarantine or hospitalization. Jingle bells, indeed.

Speaking of the FDA, MedPage Today informs us that

The FDA approved the first monotherapy for bipolar-related depressive episodes, Intra-Cellular Therapies announced Monday.

The atypical antipsychotic lumateperone (Caplyta) gained an indication for the treatment of depressive episodes associated with bipolar I or II disorder in adults, as monotherapy and as adjunctive therapy with lithium or valproate. It was first approved for adults with schizophrenia in December 2019. * * *

“The efficacy, and favorable safety and tolerability profile, make Caplyta an important treatment option for the millions of patients living with bipolar I or II depression and represents a major development for these patients,” said Roger McIntyre, MD, of the University of Toronto, in a statement released by the manufacturer. “Caplyta is approved for a broad range of adult patients including those patients with bipolar II depression who have been underserved with limited treatment options.”

Switching back to the Omicron front, the Wall Street Journal reports that

New data from Scotland and South Africa suggest people infected with the Omicron variant of coronavirus are at markedly lower risk of hospitalization than those who contracted earlier versions of the virus, promising signs that immunity as a result of vaccination or prior infection remains effective at warding off severe illness with the fast-spreading strain.

The findings begin to fill in unknowns around the severity of the disease caused by Omicron, a major variable critical to health authorities around the world as they gauge how to react to the new variant.

Scientists are still unsure how the positive findings around hospitalizations will stack up against another major variable: Omicron’s much increased transmissibility. Both variables are likely to change depending on local conditions, such as the proportion of the population that has been vaccinated against Covid-19.

“This is a qualified good news story,” said Jim McMenamin, incident director for Covid-19 at Public Health Scotland, and one of the authors of the Scottish study, at a briefing. “It’s important we don’t get ahead of ourselves. A smaller proportion of a much greater number of cases can still mean a substantial number of people that might experience severe Covid infections that could lead to hospitalization.”

From the COVID vaccine mandate challenge front, the Journal also tells us that

The Supreme Court on Wednesday said it would hold fast-track oral arguments early next month to consider whether the Biden administration can enforce Covid-19 vaccine-or-testing rules for large private employers, as well as vaccine requirements for many healthcare workers.

The cases, set for argument on Jan. 7, could go a long way to determining how much latitude the administration has to combat the coronavirus pandemic in the workplace.

The high court issued a pair of short, written orders to schedule the arguments, in response to a growing pile of emergency appeals asking the justices to intervene.

The cases haven’t yet been fully litigated in the lower courts; the Supreme Court will be deciding whether the Biden administration rules can be implemented for now. But practically speaking, the court’s decision is likely to determine whether the requirements survive. 

Curiously, it does not appear that the stay of the government contractor mandate will be presented to the Supreme Court. Instead the parties have agreed to expedite briefing and the oral arguments on the merits of the case.

From the OSHA ETS front, the Society for Human Resource Management reports that


Now that a federal appeals court has revived the Occupational Safety and Health Administration’s (OSHA’s) emergency temporary standard (ETS), covered employers will need to prepare a written COVID-19 vaccination-or-testing policy by Jan. 10.

Under the ETS, employers may choose to require vaccination or allow covered employees who are unvaccinated to wear a mask and provide proof of a negative COVID-19 test on a weekly basis. The start date for the testing requirement has been extended to Feb. 9, but many other components of the ETS take effect on Jan. 10, such as the requirement for employers to determine the vaccination status of each employee and develop a written policy.

“Keep it simple,” recommended Eric Hobbs, an attorney with Ogletree Deakins in Milwaukee. “Do not include anything in the plan that you can’t follow through on.”

The Supreme Court is unlikely to rule on the OSHA ETS mandate stay before January 10, 2022.

From the Federal employee compensation front, Federal News Network reports that

President Joe Biden on Wednesday signed an executive order making federal pay raises official for many civilian employees in 2022.

As expected, General Schedule employees will receive an across-the-board federal pay raise of 2.2% in 2022, plus an additional 0.5% locality pay adjustment, to total a 2.7% average increase.

An Office of Personnel Management official confirmed the 2.7% federal pay raise to Federal News Network Wednesday evening. The agency hasn’t yet posted detailed pay tables describing pay rates for each locality pay area.

The raises take effect Jan. 1, or more specifically during the first pay period in January.

Under OPM’s regulations, Open Season changes take place on January 1 for annuitants and on the first day of the first pay period in the new year for employees. GSA’s federal employee calendar for 2022 shows that January 2 is the first day of the first pay period for next year.

From the Affordable Care Act front, the FEHBlog apologizes that he left a sentence off yesterday’s post about the current federal fiscal year’s PCORI fee. To close the unintended loop, IRS Notice 2022-04 states that “The applicable dollar amount that must be used to calculate the [PCORI] fee imposed by sections 4375 and 4376 for policy years and plan years that end on or after October 1, 2021, and before October 1, 2022, is $2.79” per bellybutton.

Winter is here!

David Ermer–ACA, COVID treatment, COVID-19, COVID-19 testing, COVID-19 vaccine, Rx coverage, U.S. Healthcare–
Photo by Clarisse Meyer on Unsplash

The Wall Street Journal reports that “The 2021 winter solstice [took] place on Tuesday, Dec. 21, at 3:59 p.m. Coordinated Universal Time (UTC), the international standard time used by astronomers. That is 7:59 a.m. Pacific Time and 10:59 a.m. Eastern Time. * * * On the winter solstice, our planet’s [23.5 degree] tilt brings the South Pole closest to the sun—and the Antarctic Circle gets 24 hours of daylight. The North Pole is tilted away from the sun, and the Arctic Circle is shrouded in darkness for nearly a full day. * * * The winter solstice in the Northern Hemisphere marks the point at which the season’s short days start to lengthen—continuing until the summer solstice in June, when there is the longest period of daylight and the shortest period of darkness there.”

Winter solstice 2019 was pre-pandemic. Winter solstice 2020 conincided with the introduction of the mRNA vaccines in the U.S. and this winter solstice is expected to coincide with the introduction of the early onset COVID pills from Pfizer and Merck.

Bloomberg informs us that

The U.S. Food and Drug Administration is poised to authorize a pair of pills from Pfizer Inc. and Merck & Co. to treat Covid-19 as soon as this week, according to people familiar with the matter — a milestone in the fight against the pandemic that will soon expand therapies for the ill.

An announcement may come as early as Wednesday, according to three of the people. They asked not to be identified ahead of the authorization and cautioned that the plan could change. 

Pfizer’s pill, Paxlovid, and Merck’s molnupiravir are intended for higher-risk people who test positive for the coronavirus. The treatments, in which patients take a series of pills at home over several days, could ease the burden on stretched hospitals with infections poised to soar through the winter in the U.S. 

This is similar to the roll out of the mRNA vaccines which initially administered to higher-risk people as well as first responders. FiercePharma tells us that “Pfizer expects to make 80 million courses of COVID drug Paxlovid by the end of 2022.” Bloomberg adds that “’It’s the biggest thing to happen in the pandemic after vaccines,’” said Eric Topol, director of the Scripps Research Translational Institute.” For what it’s worth, the FEHBlog shares this sentiment.

In other COVID treatment news, Medscape reports that

A “definitive study” from Johns Hopkins University researchers and others shows that convalescent plasma can cut hospital admissions for COVID-19 by 54% if therapy is administered within 8 days of symptom onset.

In the study of 1181 adults randomly assigned to high-titer convalescent plasma or placebo, 2.9% of people receiving the therapy were hospitalized compared to 6.3% who received placebo control plasma.

This translates to a 54% risk reduction for hospitalization with convalescent plasma. * * *

Whereas many convalescent plasma studies were done in hospitalized patients, this is one of only a handful performed in outpatients, the researchers note.

There is a regulatory catch. The FDA restricted emergency use authorization (EUA) for convalescent plasma in February 2021 to include only high-dose titer plasma and to limit the therapy to hospitalized patients with early disease or for immunocompromised people who cannot mount an adequate antibody response.

[Dr. David] Sullivan and colleagues hope their findings will prompt the FDA to expand the EUA to include outpatients.

From the White House front, the President spoke this afternoon about an enhanced federal government response to Omicron, including federal government run testing and vaccination sites and federally funded home delivery of rapid COVID tests.

Govexec explains that

The administration will launch federal testing sites around the country, standing up the first in New York City before Christmas. It will establish subsequent sites in states and communities where capacity is constrained, a senior administration official who spoke to reporters on the condition of anonymity said on Monday, with those going up in January and February. The government will once again deploy hundreds of federal personnel to boost vaccination capacity around the country, with the goal of boosting capacity by thousands of shots per week. The Federal Emergency Management Agency will oversee pop-up vaccination sites operated by the federal government, with the first ones going to Washington and New Mexico.  * * *

The White House also announced it was purchasing 500 million tests and will soon set up a website for any Americans to order one for free. The tests will be available in January and delivered by mail for free, though the White House is still finalizing how many each individual will be entitled to order. The administration pledged to boost its use of the Defense Production Act to boost the supply of at-home, rapid tests.

It’s not yet clear whether this initiative replaces the earlier proposal to have health plans reimburse their members for these over the counter tests.

The San Franciso Chronicle seeks to put the transmissibility of Omicron in perspective

The reproductive number known as R0, pronounced “R naught,” measures a disease’s transmissibility at the beginning of a pandemic with no preexisting immunity, said Warner Greene, a virologist and senior investigator at the Gladstone Institutes in San Francisco. It represents how many people one sick person will infect.

According to a study released in October, the original COVID-19 strain that emerged from Wuhan has an R0 value of 2.79. The delta variant has a value of between 5 to 6 — about twice as contagious as the original strain.

Chicken pox has an R0 value of 9-10. The R0 value of measles is estimated at 12 to 18.

Greene said to really know the true R0 value of omicron, more information is needed. He cited an estimate from Martin Hibberd, a professor of emerging infectious diseases at the London School Of Hygiene & Tropical Medicine, that omicron could have an R0 of 10.

Chin-Hong said “a lot more fully vaccinated people will get breakthrough infections, but will not likely get very ill and are very unlikely to die.”

For unvaccinated people, the situation is much more serious.

“It will be very difficult to avoid getting infected with omicron,” Swartzberg said. “You may have been lucky with the other variants and the ancestral strain. It’s unlikely you will be with omicron. The unvaccinated will be the biggest spreaders of omicron and they will be the ones most likely hospitalized from it.”

No joke.

From the National Institutes of Health front —

  • “Yesterday the U.S. Food and Drug Administration announced its first approval of a long-acting HIV prevention medication. Developed by ViiV Healthcare, the medicine is long-acting cabotegravir injected once every two months. FDA has approved the medicine for use by adults and adolescents weighing at least 35 kilograms who are at risk of sexually acquiring HIV. This milestone marks a vital expansion of biomedical HIV prevention options available to people in the United States.”
  • “Despite important advances in the understanding and treatment of oral diseases and conditions, many people in the U.S. still have chronic oral health problems and lack of access to care, according to a report by the National Institutes of Health. Oral Health in America: Advances and Challenges, is a follow-up to the seminal 2000 Oral Health in America: A Report of the Surgeon General.” * * * “The authors make several recommendations to improve oral health in America, which include the need for health care professionals to work together to provide integrated oral, medical, and behavioral health care in schools, community health centers, nursing homes, and medical care settings, as well as dental clinics. They also identify the need to improve access to care by developing a more diverse oral health care workforce, addressing the rising cost of dental education, expanding insurance coverage, and improving the overall affordability of care.”

From the Affordable Care Act front, the Internal Revenue Service announced today that the applicable dollar amount that health plans must use to calculate the [PCORI] fee imposed by sections 4375 and 4376 for policy years and plan years that end on or after October 1, 2021, and before October 1, 2022, is $2.79″ per bellybutton. The immediately preceding years fee was $2.66 per bellybutton.

Monday Roundup

David Ermer–CDC, COVID vaccine mandate, COVID-19, COVID-19 vaccine, Rx coverage, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

From the Omicron front, STAT News reports that

The Omicron variant now accounts for 73% of Covid-19 infections being diagnosed in the United States, and in some parts of the country 90% of infections are caused by viruses from the Omicron strain, the Centers for Disease Control and Prevention said late Monday.

Though it’s been clear from Omicron’s astonishing spread elsewhere that it would rapidly take over from Delta as the dominant variant in this country, the speed is nevertheless startling to witness.

“What we are watching unfold is microbial evolution. This is remarkable,” said Michael Osterholm, director of the University of Minnesota’s Center for Infectious Diseases Research and Policy. “But this is what these viruses can do.”

The Centers for Disease Control updated its Omicron website today.

This Wall Street Journal article indicates the obtaining an mRNA booster (Moderna or Pfizer) will provide protection against Omicron as well as Delta.

The Centers for Medicare and Medicare Services today updated their “vaccine toolkit designed for issuers of group and individual health insurance and Medicare Advantage health plans.”

From the COVID vaccine mandate litigation front, the American Hospital Association reports that

Over the weekend, and as of this writing, eight groups of challengers to the OSHA vaccine mandate filed emergency applications with the U.S. Supreme Court asking the high court to once again stay the mandate following the Sixth Circuit’s Dec. 17 decision to lift the Fifth Circuit’s previously entered stay.
 
Today, the Supreme Court asked the federal government for a response to the challengers’ applications by Dec. 30 by 4 p.m. If that sounds familiar, it is because Dec. 30 at 4 p.m. is also the date and time the challengers to the CMS vaccine mandate will be filing their responses to the federal government’s Supreme Court application asking the court to stay the Missouri and Louisiana preliminary injunctions enjoining the CMS mandate. Both sets of applications will be briefed at the same time and the Supreme Court will have the opportunity to rule on the fate of both the CMS and OSHA vaccine mandates at the same time, if it so chooses.

The FEHBlog can find no word about whether the government has appealed to the Supreme Court the 11th Circuit’s decision last Friday to maintain in force the stay on the federal government contractor COVID vaccine mandate. The FEHBlog will keep looking.

From the healthcare business front —

  • Fierce Healthcare informs us that “Amazon has consolidated its healthcare efforts under one central organization and tapped a former Prime executive to run the businesses. The tech giant elevated Neil Lindsay to the new role of senior vice president of health and brand within Amazon’s worldwide consumer business, an Amazon spokesperson confirmed to Fierce Healthcare.”
  • mHealth Intelligence reports that “Supermarket retailer Hy-Vee, Inc. has launched a telehealth platform that allows individuals to receive treatments and prescriptions through the mail. The new service, RedBox Rx, offers virtual health consultations through a partnership with Reliant Immune Diagnostics’ telehealth platform MDbox.”
  • Healthcare Dive tells us that

Software giant Oracle is acquiring EHR vendor Cerner for $28.3 billion, the two companies announced Monday. The deal is expected to close sometime next year.

It will be Oracle’s largest acquisition to date, with the next highest being the 2005 purchase of PeopleSoft Inc. for $10 billion. The deal further pushes Oracle into the healthcare market, where its presence is mostly in data use efficiency for payers and providers. Oracle’s areas of focus include database software and cloud systems.

Cerner will be a dedicated business unit within Oracle, according to the Monday press release. Voice-enabled user interfaces will be a key focus with a goal to “deliver zero unplanned downtime in the medical environment.”

From the too little too late front, STAT News tells us that

Biogen said Monday that it has reduced the price of its Alzheimer’s drug Aduhelm by half and is planning a series of cost-cutting measures across the company next year that aim to save $500 million.

The moves follow a disappointing commercial launch of Aduhelm, as well as anger over the drug’s high price. 

The new, lower price for Aduhelm is $28,200, or roughly half what the drug cost when it launched in June. Insurance companies balked at its original list price, averaging $56,000 a year per patient, while physicians have fervently questioned whether Biogen’s supporting evidence merited the drug’s approval by the Food and Drug Administration, let alone widespread use. * * *

Biogen is announcing the Aduhelm price cut less than one month before Medicare is expected to make an all-important decision on whether and how widely to pay for the drug. A draft ruling is expected in January, followed by a final decision in the spring.

But with Aduhelm delivering paltry revenue, Biogen is also being forced to downsize the company. On Monday, Biogen said it would implement a series of cost-cutting measures in 2022 that are expected to total approximately $500 million. Details will be announced in the first quarter. 

Friday Stats and More

David Ermer–COVID vaccine mandate, COVID-19, COVID-19 vaccine, U.S. Healthcare–

Using the CDC’s COVID Data Tracker and Thursday as the first day of the week, here is the FEHBlog’s weekly chart of new COVID cases for 2021:

Here is a link to the CDC’s weekly chart of new COVID admissions which also continues to trend up.

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

Here is the FEHBlog’s weekly chart of new COVID vaccinations administered and delivered from the 51st week of 2020 through the 50th week of the 2021. For the second week in a row, administered vaccines including boosters has exceeded 10 million for the week.

Here’s a link to the CDC’s weekly interpretation of its COVID statistics. The CDC weekly review will not be published again until January 7. Hopefully by then the FDA will have granted emergency use authorization to the Pfizer early onset COVID pill. That would be a great holiday gift for America.

The CDC’s Fluview reports that “Seasonal influenza activity in the United States is increasing, including indicators that track hospitalizations. The amount of activity varies by region.”

From the COVID vaccine front, the Wall Street Journal informs us that

Pfizer Inc. and partner BioNTech SE  have pushed back plans to request authorization of their Covid-19 vaccine in children ages 2 to 5, after the shot generated a weaker than expected immune response in a key study. 

The companies said Friday they would begin testing the addition of a third dose in the children, and if successful, would ask U.S. health regulators to authorize use sometime during the first half of 2022.

STAT News tells us that CDC Director Rochelle Walensky has approved her Advisory Committee on Immunization Practice’s unananimous “preferential recommendation to the Covid vaccines based on messenger RNA technology on Thursday — a decision aimed at steering people away from the Johnson & Johnson Covid-19 vaccine because of concerns about a rare but serious side effect.” STAT dives into more detail in an accompanying article titled “The Tragedy of Johnson & Johnson’s COVID vaccine.

In COVID vaccine mandate news the Wall Street Journal reports this evening that

A federal appeals court Friday reinstated Biden administration rules that require many employers to ensure that their workers are vaccinated or tested weekly for Covid-19.

A divided panel of the Sixth U.S. Circuit Court of Appeals dissolved a stay issued by another court that had blocked the rules. The majority, in a 2-t,o-1 ruling, said legal challenges to the administration’s vaccination-and-testing requirements were likely to fail.

This decision was made in the consolidated challenge to the OSHA action. The Sixth Circuit reversed a Fifth Circuit stay of the OSHA action. The plaintiffs are likely to ask all of the 6th Circuit’s active judges to consider this issue, e.g., a motion for rehearing en banc

In other judicial news, STAT News reports that

A federal court judge has reversed the hotly contested Purdue Pharma bankruptcy plan after deciding a bankruptcy judge did not have authority to grant immunity to the Sackler family members who control the controversial drug maker. * * *

One legal expert explained the decision is significant. “The decision is an important recognition of the arguments made (by the U.S. Trustee and the eight states) and the concerns they had. That is an important value for a justice system,” Melissa Jacoby, a professor at the University of North Carolina who specializes in bankruptcy law, wrote us.

So what happens next?

“…It is too soon to know what the effect will be. It is possible the Sacklers will increase their monetary offer to avoid further litigation to try to make the releases fully consensual, even though I can imagine grounds on which the 2nd circuit (appeals court) would reverse the district court,” she continued. “Presumably, they are examining those options right now.”

In M&A news, Healthcare Dive informs us that

— Intermountain Healthcare and Colorado-based SCL Health signed a definitive agreement Wednesday to move forward with merger plans to create an $11 billion health system spanning six states.

— The deal is expected to close next April. Financial terms were not disclosed.

— Intermountain CEO Marc Harrison will serve as the leader of the combined organization.

Thursday Miscellany

David Ermer–Congress, COVID vaccine mandate, COVID-19, COVID-19 testing, COVID-19 vaccine, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

From the Capitol Hill front, Roll Call reports that

President Joe Biden and Democratic leaders reluctantly acknowledged Thursday that the Senate would soon recess for the year without passing their sprawling $2.2 trillion social safety net and climate spending bill or voting rights legislation. 

From the Omicron front, Bloomberg tells us that

President Joe Biden warned that unvaccinated Americans face “a winter of severe illness and death” as he urged initial doses and booster shots amid a surge of coronavirus cases and the emergence of the omicron variant.

David Leonhardt writing in his New York Times Morning column adds that “about 15 percent of American adults remain unvaccinated.”

From the COVID vaccine front, AHIP informs us that

Today, the CDC’s Advisory Committee on Immunization Practices (ACIP) convened to discuss the recent developments and safety considerations for the Janssen/Johnson & Johnson COVID-19 vaccine. 

ACIP voted unanimously to amend their recommendation: mRNA COVID-19 vaccines are preferred over the Janssen COVID-19 vaccine for the prevention of COVID-19 for those 18 years of age and older. 

Deliberations within the committee stressed the importance of updating the Clinical Considerations and educational materials regarding the vaccine to ensure that anyone who chooses to receive the Janssen adenovirus-based vaccine is informed of the potential risks.  

Earlier this week, the FDA updated its Emergency Use Authorization Fact Sheet to indicate that the Janssen vaccine is contraindicated for individuals with a history of thrombosis with thrombocytopenia syndrome (TTS).  This was based on new information showing that cases of TTS have been reported in both males and females, and that approximately 15% of TTS cases have been fatal.

Following the discussion, the Committee reviewed a presentation on safety data regarding the use of the Pfizer-BioNTech COVID-19 vaccine in children aged 5-11 years old.  Very few adverse events or severe systemic reactions were reported, with most incidents including pain, fever, fatigue, headache, and/or myalgia, and most beginning one or two days following the second dose with symptoms alleviating within a few days.  To date, there have been two deaths in children who received the vaccine, each with children who have complicated medical histories, both of which are still under investigation.

Finally, CDC presented current data about the Omicron variant.  This variant appears to be more transmissible than earlier variants, but more data is needed to know if it causes more severe illness.  Vaccines are expected to protect against severe illness, hospitalizations, and death, with booster vaccines showing increased protection than the two-dose series.  It is unclear how prior infection impacts neutralization.  CDC is continuing to monitor real-world evidence across all populations to inform further action.

Also from the omicron front, Healthcare Dive reports that

— FDA has identified three COVID-19 molecular tests that are not able to detect the omicron variant and warned that the diagnostics from Applied DNA Sciences, Meridian Bioscience and Tide Laboratories will return false negative results.

— The agency on Wednesday updated its list of tests impacted by virus mutations. While FDA continues to gather additional information and work with the three manufacturers to address these issues, it recommended the diagnostics not be used by clinical laboratory staff and healthcare providers.

— Makers of both polymerase chain reaction and rapid antigen tests have said their tests can detect omicron. Siemens Healthineers is the latest company to claim its testing portfolio is unaffected by the variant. However, Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, told test developers Wednesday during a virtual town hall that the agency continues to receive “a lot of inquiries” about omicron and its potential impact on diagnostics and will continue to focus efforts on evaluating molecular and antigen tests.

The Wall Street Journal adds that

Pfizer Inc. and BioNTech SE  say they have asked U.S. regulators to fully approve their Covid-19 vaccine for adolescents ages 12 to 15. The vaccine was fully approved by the U.S. Food and Drug Administration in August for people 16 years and older. 

From the COVID vaccine mandate front, we have two court decisions:

  • The Society for Human Resources Management explains that “On Dec. 15, the 5th U.S. Circuit Court of Appeals lifted a district court’s order that had blocked the Biden administration’s COVID-19 vaccination directive for health care workers nationwide. But the requirement remains blocked in 24 states.” The 24 states are composed of 14 State plaintiffs in the 5th Circuit case and 10 State plaintiffs in the first PI. The Congressional Research Service recently wrote a report on nationwide injunctions.
  • The government contractor mandate nationwide preliminary injunction (“PI”) followed the same course as the healthcare workers preliminary injunction — a PI issued for three states followed by a court in another state issuing a nationwide injunction. Perhaps the 11th U.S. Circuit Court of Appeals which is hearing the government’s appeal of the government contractor mandate PI (Case No. 21-14269), will follow the 5th Circuit’s lead.
  • The National Law Review reports that

[Also on Dec. 15] The [U.S. Court of Appeals for the] Sixth Circuit denied en banc review in the OSHA vaccine mandate cases.  The vote was a close one, with eight judges voting in favor of initial hearing en banc.  But that’s not enough under the circuit’s rules, which require a majority of the 16 active judges to vote for en banc treatment.  As a result, the current panel reviewing the case will decide whether to continue the stay issued by the Fifth Circuit, which may end up being the most consequential decision in the case until it comes before the Supreme Court.

From the miscellany department —

  • GoodRx brings us up to date on Alzheimer’s Disease research.
  • “The HEALTH CARE TRANSFORMATION TASK FORCE (HCTTF or Task Force), a group of leading health care payers, providers, purchasers and patient organizations, today announced that its provider and payer members reported having 61 percent of their business in value-based payment arrangements at the end of 2020. Value-based care and payment arrangements focus on lowering costs and improving the quality of care to drive overall population health. The new report shows significant progress towards the goal and has increased twofold from the group’s first report of 30 percent in value-based arrangements in 2015.”

Roughly 40% of U.S. healthcare payments were tied to alternative payment models (APMs) last year, with Medicare Advantage claims representing the largest amount, a new survey found.

The survey, published Wednesday by the Health Care Payment Learning & Action Network, showed that more work needs to be done as most healthcare payments were still tied to a fee-for-service model.

“The survey shows we have made limited progress in moving away from fee for service between 2019 and 2020,” said Mark McClellan, M.D., Ph.D., director of Duke University’s Margolis Center for Health Policy and co-chair of the LAN CEO forum, during the LAN Summit Wednesday. “Most payments are still in fee-for-service, especially outside of Medicare.”

  • If you are bit confused by these findings, APMs are a type of value based pricing arrangement. Health Affairs offered a useful article on the various value based payment models earlier his year.

Weekend Update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, No Surprises Act, OPM, U.S. Healthcare–

Congress will remain in session for Committee business and floor voting.

The focus of attention will be the President’s Build Back Better Act. The Senate Finance Committee released the text of its portion of the Senate version of the BBB Act yesterday. The Wall Street Journal explains that

President Biden this week will lobby Sen. Joe Manchin, the centrist West Virginia Democrat, in an attempt to lock in a deal on a roughly $2 trillion social-policy and climate bill that Democrats hope to finish by Christmas.

Passage hinges largely on the support of Mr. Manchin, who hasn’t endorsed the legislation. He has repeatedly raised concerns about the cost of the bill and the potential effect of new government spending on inflation. Messrs. Biden and Manchin plan to talk early this week, a Senate aide said.

Senator Manchin’s vote is critical because the Democrat’s can’t lose one vote in the evenly divided Senate as the Republicans in the Senate all intend to vote against the bill. The Journal adds

With Democrats holding the narrowest congressional majority in decades, passing the sweeping bill is akin to threading yarn through a tiny needle. Democrats already navigated past opposition from Arizona Democratic Sen. Kyrsten Sinema on several of the tax increases they originally had proposed, making revenue-generation intended to pay for the legislation difficult.

Ms. Sinema hasn’t endorsed the House-passed bill. Democrats have also needed to write a bill that lawmakers from the party’s most progressive wing would support, along with centrists.

Because the Senate bill will not mirror the already passed House bill, the two Houses of Congress might convene a conference committee. Time will tell.

Tomorrow is the last day of the current Federal Benefits Open Season. OPM explains that

The Federal Benefits Open Season ends at 11:59 pm Eastern Time on Monday December 13, 2021 for the Federal Employees Dental and Vision Insurance Program (FEDVIP) and the Federal Flexible Spending Account Program (FSAFEDS). Open Season for the Federal Employees Health Benefits Program (FEHB) ends at 11:59 pm, in the location of your electronic enrollment system, on Monday December 13, 2021.

From the No Surprises Act front, the Kaiser Family Foundation offers a consumer friendly overview of the law’s provisions that take effect on January 1, 2021. Basically, FEHB plans will pay certain out-of-network (“OON”) providers (emergency care, air ambulance, and OON providers when the patient is treated at an in-network facility) a qualifying payment amount (“QPA”), net of the in-network cost sharing amount which is the member’s financial responsibility. If the provider is dissatisfied with the QPA, he or she must work out the matter with the health plan. The member therefore is held harmless against the outcome of that controversy.

These QPA provisions, however, are inapplicable to claims submitted for FEHB plan members who have primary Medicare coverage or in the case of fee for service plans have primary Medicare Part A only. Also if another payer is primary to the FEHB plan, e.g., a spouse’s plan, then the primary plan is responsible for compliance with the No Surprises Act. The FEHB plan is responsible only for making the secondary payment, which usually equals the primary plan’s deductibles and co-insurance.

From the health care business front, Medcity News informs us that

After a challenging quarter, insurance company Bright Health is raising $750 million in financing. In an unusual move, another insurance company is joining as an investor. Cigna Ventures and Bright’s largest shareholder, New Enterprise Associates, both participated in the financing.

Head of Cigna Ventures Tom Richards talked about potential opportunities to collaborate with NeueHealth, Bright’s provider enablement platform to help practices move to value-based contracts.

“We seek to be partners of choice and we look forward to exploring new ways that NeueHealth and Evernorth can potentially provide services to each other’s customers and clients,” he said in a news release.

From the Omicron front, Bloomberg reports (recall last week’s post about U.S. experts tracking the U.K.’s experience with Omicron because the United Kingdom started to experience Omicron cases before the U.S.):

Prime Minister Boris Johnson warned the U.K. is facing a “tidal wave” of omicron infections and set an end-of-year deadline for the country’s booster vaccination program. Infections in the U.K. from the new variant doubled in the last day and now make up a third of new cases in London. 

Anthony Fauci, U.S. President Joe Biden’s chief medical adviser, said omicron appears able to evade vaccines and some Covid-19 treatments but that a booster shot can increase protection. At least 30 U.S. states are reporting cases of the variant.  

CNBC adds that “Covid booster shots are “optimal care” as the deadly virus continues to mutate and spread, but the U.S. government is staying firm for the time being on the definition of fully vaccinated, top U.S. infectious disease expert Dr. Anthony Fauci said Sunday.”