Monday Roundup

Monday Roundup

Photo by Sven Read on Unsplash

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

The Times also informs us that

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

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

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

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

Fingers crossed on the pill.

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

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

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

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

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

Weekend update

Photo by Tomasz Filipek on Unsplash

The U.S. House of Representatives and Senate continue to be engaged in Committee business and floor voting this week which should be a humdinger on Capitol Hill. The Wall Street Journal sums the situation up as follows:

Congress Heads Into Tumultuous Week Pressured by Converging Deadlines
Government shutdown, debt ceiling loom as Democratic leaders plan votes on multitrillion-dollar spending ambitions

The Supreme Court prepares for the opening of its October 2021 term on October 4. Amy Howe informs us

The Supreme Court announced on Tuesday that oral arguments will follow a slightly different plan when the justices return to the courtroom for in-person arguments next month. Instead of reverting entirely to the traditional “free for all” format for asking questions, the justices will adopt a hybrid approach that sets aside time for the justices to take turns asking questions, just as they did when hearing oral arguments by telephone during the pandemic. The change appears to increase the chances that Justice Clarence Thomas, who was rarely heard in the courtroom but was an active participant in remote arguments, will continue to participate when in-person arguments resume.

How collegial.

We also can look forward to the Departments of Health and Human Services, Labor, and Treasury as well as OPM issuing the second big No Surprises Act interim final rule this week. The statutory deadline for releasing this rule concerning the independent dispute resolution process is Friday October 1.

From the Delta variant front

  • Both CVS Health and Walgreen’s have announced that their multitude of pharmacies are offering the Pfizer booster to all eligible folks.
  • If you noticed the articles recently reporting that the number of COVID-19 deaths in America exceeds the 1918 flu pandemic, check out this Health Affairs blog article from last April debunking this apples to oranges comparison.

In any event check out this Health Payer Intelligence article on three strategies for sustaining payer innovation momentum post-pandemic. “The coronavirus pandemic resulted in accelerated payer innovation and payers can continue that momentum by identifying opportunities, involving members, and using data effectively.”

Friday Stats and More

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 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.”

Friday Stats and More

Based on the Centers for Disease Control (CDC) constantly improving COVID data tracker website, here are charts of new weekly COVID-19 cases and deaths using Thursday as the first day of the week. As you can see, new cases trended down last week. Per the CDC, “The current 7-day moving average of daily new cases (136,558) decreased 12.7% compared with the previous 7-day moving average (156,341).” Moreover, “The current 7-day moving average of new deaths (1,077) has decreased 11.3% compared with the previous 7-day moving average (1,214).”

Here are links to the COVID hospitalization statistics and the CDC’s weekly interpretation of its COVID data. Per the CDC, “The current 7-day daily average for September 1–September7, 2021, was 11,754 This is a 4.1% decrease from the prior 7-day average (12,251) from August 25–August 31, 2021.”

Here is chart of weekly COVID vaccines distributed and administered from the time administration began last December through the 36th week of this year (ending September 8, 2021):

New vaccinations have levelled out at a rate of roughly 5 million per week for the past two months. Per the CDC, “As of September 9, 2021, 92.6% of people ages 65 years or older have received at least one dose of vaccine and 82.2% are fully vaccinated. Over three-quarters (75.3%) of people ages 18 years or older have received at least one dose of vaccine and 64.5% are fully vaccinated. For people ages 12 years or older, 73.4% have received at least one dose of vaccine and 62.5% are fully vaccinated.”

The Food and Drug Administration today released this bulletin about the status of making available a COVID vaccine for young children.

The FDA is working around the clock to support the process for making COVID-19 vaccines available for children. As outlined above, this process is complex and relies on robust manufacturer trials and data, and while we cannot offer a specific date or timeline for when it may be completed for the various manufacturers’ vaccine candidates, we can assure the public we are working as expeditiously as possible to meet this critical public health need and we very much hope to have pediatric COVID-19 vaccines available in the coming months.

The New York Times reports

Federal health officials released new data showing that unvaccinated Americans are 11 times as likely as vaccinated people to die of Covid-19.

Three large studies, published on Friday by the Centers for Disease Control and Prevention, also highlighted the effectiveness of the shots at preventing infection and hospitalizations with the virus.

The research underscored a deep conviction among scientists that vaccine hesitancy and refusal have prolonged the pandemic. The administration’s new plan should stem the flood of infections and return the country to some semblance of normalcy in the long term, several experts said in interviews.

With respect to the President’s vaccination mandates, Gov Exec tells us that

The U.S. Postal Service is not committing to implementing any COVID-19 vaccine mandate—full or partial—for its workforce, with an agency spokesman saying officials will first need to see the fine print of new requirements President Biden has issued. 

Biden’s executive order mandating the vaccines for the federal workforce took a somewhat narrow definition of agencies that carved out USPS, which employs more than 640,000 people. The president on Thursday also announced the Labor Department would put forward a rule directing all employers with more than 100 workers to require their staff to either be vaccinated or submit to weekly COVID-19 testing. USPS said on Friday it was still determining whether the rule would apply to the agency.

From the No Surprises Act front, HHS has issued its proposed rule implementing the Consolidated Appropriations Act 2021 Division BB provisions on air ambulance reporting, health insurer / plan broker compensation reporting and HHS enforcement of the law. Here is a link to a fact sheet on the proposal. The public comment deadline is October 18.

HHS also announced today that its “Health Resources and Services Administration (HRSA), is making $25.5 billion in new funding available for health care providers affected by the COVID-19 pandemic. This funding includes $8.5 billion in American Rescue Plan (ARP) resources for providers who serve rural Medicaid, Children’s Health Insurance Program (CHIP), or Medicare patients, and an additional $17 billion for Provider Relief Fund (PRF) Phase 4 for a broad range of providers who can document revenue loss and expenses associated with the pandemic.” The American Hospital Association was pleased with the news.

Federal News Network has interviewed many current and former federal employees about their memories of September 11, 2001. Check it out as the interviews include two OPM officials. Of course, never forget.

Midweek Update

Photo by Tomasz Filipek on Unsplash

Yesterday was the deadline for submitting public comments on the first No Surprises Act (“NSA”) interim final rule. The first IFC concerns the surprise billing protections afforded to consumers in emergency case, out of network care at in-network facilities and air ambulance care.

Here is potpourri of pertinent articles from Becker’s Payer Issues (about AHIP’s comments), the American Hospital Association, and Health Leaders Media (MGMA’s comments). When the same tri-agencies issued interim final rules implementing the Affordable Care Act (“ACA”) in 2011, those agencies did not issue “final final” rules until four or five years later.

While the NSA law is narrower in scope than the ACA, it poses much more complicated administration issues than those ACA provisions. Consequently the final final NSA rules may be accelerated. Sensibly, AHIP suggests that the tri-agencies create a good faith safe harbor for health plans and insurers during 2022 and 2023 to allow them to come into full compliance with this complex law.

In other healthcare news

  • A friend of the FEHBlog called his attention to the September 2021 issue of NIH in the News which may provide useful article for health plan newsletters to members.
  • The Journal of AHIMA breaks down the ICD-10 diagnosis code changes that will take effect on October 1, 2021, under the HIPAA transactions and code sets rule.
  • NCQA has made available a kidney health toolkit.
  • Fierce Healthcare reports that “Anthem is teaming up with The Clinic by Cleveland Clinic to offer virtual second opinions to members. The Clinic is a digital health joint venture from Cleveland Clinic and Amwell that provides video consultations, digital record collection and concierge service to insurers, providers, employers and patients. Through the partnership, eligible members can seek online second opinions from the health system’s 3,500 physicians. Anthem will initially make these consults available to its large employer clients, with the potential to expand to other employers and other insurance programs, according to the announcement.”
  • Health Payer Intelligence tells us that “In 2020, the prevalence of employer-sponsored health plan coverage fell during the coronavirus pandemic even as employment rebounded, according to a recent study published in the JAMA Health Forum. * * * In 2021, the data forms a clearer picture. Employer-sponsored healthcare coverage declined even as employment levels recovered, potentially indicating a shift to Affordable Care Act marketplace or Medicaid plans.” That is hardly surprising given the enormous funding that Congress has provided to the ACA marketplace.

Finally, the Wall Street Journal’s the Future of Everything series today discusses how

Researchers around the world are trying to turn the humble cough into an inexpensive tool to diagnose and stop respiratory-disease killers like tuberculosis and Covid-19. They’re collecting recordings of millions of the explosive sounds from patients and consumers on smartphones and other devices. And they’re training artificial intelligence to find patterns to try to identify the type and severity of disease from the cough itself. 

“We call it acoustic epidemiology,” says Peter Small, a tuberculosis expert and chief medical officer of Hyfe Inc., a Delaware-based company with two free smartphone apps—one for consumers, another for researchers—that use AI to detect and track how often someone coughs.

Friday Stats and More

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 33rd week of this year (beginning April 2, 2020, and ending August 18, 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 18, 2021):

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through August 18, 2021, which also uses Thursday as the first day of the week:

Here’s a link to the CDC’s weekly interpretation of its COVID-19 statistics.

Politico reports that “More than one million Americans received a dose of Covid-19 vaccine on Thursday[August 19] , a benchmark the nation has not met in nearly seven weeks amid a resurgence of the coronavirus pandemic.”

HealthDay informs us that

Antibodies generated by COVID-19 vaccines are effective against the Delta variant and other coronavirus variants of concern, new research shows.

The findings may help explain why most vaccinated people have avoided the surge of Delta variant cases sweeping across the United States.

“In face of vaccination, Delta is relatively a wimpy virus,” said study co-author Ali Ellebedy, an associate professor of pathology and immunology at Washington University School of Medicine in St. Louis.

Good to hear.

The Wall Street Journal tells us that

The Food and Drug Administration is expected next week to grant full approval of the Covid-19 vaccine from Pfizer Inc. and partner BioNTech SE, according to people familiar with the planning, an action that could spur more vaccination requirements by employers and encourage more people who are hesitant to get vaccinated. * * *

Once fully approved, the vaccine would be eligible for off-label prescriptions, such as booster doses, according to the FDA. However, analysts said, the critical element for broad boosting is a recommendation from the Advisory Committee on Immunization Practices to the FDA, as physicians often follow ACIP recommendations.

With full approval, Pfizer would likely be permitted to market the vaccine to doctors, providers and the general public as it does with other approved products. The FDA is permitted to restrict such communications with emergency authorization.

The Journal adds that

Of the three authorized vaccines in the U.S., only Pfizer has submitted all the required information to the FDA, according to the companies, and analysts expect it to be the first receive clearance. 

Moderna Inc., whose authorized two-dose shot uses similar mRNA technology as the Pfizer-BioNTech, has said it is still completing rolling data submissions.Johnson & Johnson, whose shot was authorized in February, has said it plans to file for full approval later this year.

Fierce Healthcare reports that Janet Woodcock will not be nominated for a promotion from acting to permanent Food and Drug Commissioner due in large part to Aduhelm fallout.

From the regulatory front

  • After issuing a minimalist Affordable Care Act (“ACA”) FAQ 48 earlier this week, the ACA regulatory departments issued a blockbuster ACA FAQ 49 about payer transparency rule implementation and enforcement delays and answering many No Surprises Act (“NSA”) implementation issues left hanging by the first NSA interim final rule (“IFC”) released July 1.
  • OMB’s Office of Information and Regulatory Affairs (“OIRA”) has scheduled more meetings on the second No Surprises Act IFC which concerns the independent dispute resolution process. Those listening sessions now run late into next week. That means that the IFC won’t be released before the week of August 30 but that still would be about a month before the statutory deadline.
  • The American College of Emergency Physicians and Blue Cross each met with OIRA this past week. Here are links to their supporting letters. BCBSA OIRA IDR 8.17.21.pdf and ACEP EDPMA Pre-IDR Rulemaking Letter (8.10.21).pdf Common sense as expressed in the Blue Cross letter must prevail if the parties want to avoid having the second IFC also create major system changes.
  • The Society for Human Resource Management informs us that “covered employers [such as FEHB plan carriers] now have until Oct. 25 to file their 2019 and 2020 EEO-1 reports, according to a recent announcement from the U.S. Equal Employment Opportunity Commission (EEOC). Although the reporting deadline has been delayed several times during the COVID-19 pandemic, the agency said it will not authorize any more extensions.”

Weekend update

The House of Representatives is on a long District work break this month while the Senate has one more week of Committee business and floor voting before that body begins its State work break.

The Wall Street Journal reports from the Delta variant front

While the number of cases in the U.S. had climbed, the number of Americans getting vaccinated also surged, particularly in states like Louisiana, Arkansas and Mississippi, where the rates of vaccination were lower, the officials said. Roughly 60% of eligible Americans are fully vaccinated.

The Journal adds that

One recent vaccine recipient was Manny Cid, the 37-year-old mayor of Miami Lakes[, Florida]. He held off on getting a vaccine earlier in the pandemic because the virus seemed to affect mostly older people and he worked out daily and felt healthy, he said. Over time, his thinking changed as he saw young athletes and acquaintances suffer severe bouts of Covid-19. Then the Delta variant emerged, along with research showing people infected with it carry 1,000 times the viral material of people with the original strain. He decided to get a shot Monday.

“Seeing the impact of the Delta variant, attending funerals of people I highly respect, seeing more and more young people in bad shape…that’s really scary,” Mr. Cid said. “We’ve got to protect ourselves.”

In an interesting development, Health Payer Intelligence informs us that “Based on 75 individual [Affordable Care Act] marketplace rate filings, the coronavirus pandemic is not expected to meaningfully affect healthcare spending in 2022, a Peterson-Kaiser Family Foundation (KFF) Health System Tracker brief explained.”

The Centers for Disease Control reminds us that August is National Immunization Awareness Month. Hey health plans, “National Immunization Awareness Month (NIAM) is an annual observance held in August to highlight the importance of vaccination for people of all ages. Use these resources to assist you in communicating to healthcare professionals, parents, and patients about immunization during August and throughout the year.

Friday Stats and More

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 30th week of this year (beginning April 2, 2020, and ending July 28, 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 July 28, 2021):

Finally here is a COVID-19 vaccinations chart over the period December 17, 2020, through July 28, 2021, which also uses Thursday as the first day of the week:

Due to the Delta variant, new cases and hospitalizations are trending up while new deaths have remained low for two months.

Happily COVID-19 vaccinations are trending up again. As of today according to the CDC, 60% of the U.S. population over age 18 and 80% of those over age 65 are fully vaccinated. GEHA, the largest employee organization plan in the FEHB, announced that it has extended its COVID-19 vaccine incentive program to Labor Day, September 6.

The CDC defended its new masking policy for the vaccinated population by pointing to a case in which as reported by the Wall Street Journal

127 vaccinated people infected with the Delta variant during the outbreak appeared to carry as much virus as 84 unvaccinated or partially vaccinated people who became infected. The report referred to an outbreak in Barnstable County, Mass. Local officials there have said that at least 430 confirmed Covid-19 cases have been linked to one cluster following festivities over the July 4 weekend in Provincetown, on the tip of Cape Cod.

Among the 469 cases linked to the Barnstable outbreak in the CDC report, nearly 75% were fully vaccinated. For people with breakthrough infections, almost 80% had symptoms of cough, headache, sore throat or fever. Four were hospitalized and no deaths were reported, the CDC said. Infected people reported attending densely packed indoor events and outdoor events at bars, restaurants and houses.

Toward the conclusion of the article the journalist speaks with Dr. Ashish Jha, dean of the public-health school at Brown University.

Dr. Jha said he thinks this week’s guidance recommending masking in high-risk areas of the U.S. was reasonable, but also risked suggesting that vaccines aren’t effective against the Delta variant, which could discourage unvaccinated people from getting shots. We have the tools to address this variant, and they’re called vaccines,” Dr. Jha said.

The FEHBlog certainly would wear a mask at an indoor or outdoor super spreader event in a high risk area like the one where the FEHBlog is temporarily living, Travis County Texas. It’s worth noting this US Health Weather map which gauges the risk of catching a respiratory infection like COVID-19 or the flu in a particular US county. Ironically, my county of permanent residence, Montgomery County, Maryland, is low risk.

STAT News adds that the Food and Drug Administration is accelerating the process of reviewing Pfizer-Biotech’s application for full marketing approval of their COVID-19 vaccine. (Moderna also has made this filing.)

A typical review of an application like Pfizer’s takes 10 months. The agency granted Pfizer a “priority review” for its vaccine earlier this month, which signifies that staff will strive to finish the review of the application within six months. At the same time, he FDA has said it does not expect the process to take that long — a view echoed even by President Biden.

“My expectation …  is that sometime, maybe in the beginning of the school year, at the end of August, beginning of September, October, they’ll get a final approval” Biden said last week when asked when the FDA would formally approve the Covid-19 vaccines, including the one developed by Pfizer and its partner BioNTech.

Jesse Goodman, who led the FDA’s biologics center from 2003 to 2009, said that the August-September time frame is “possible … if all goes smoothly.” He said the idea of a sprint is “reasonable,” so long the biologics center follows the normal chain of command for reviewing these applications.

In other news

  • Federal News Network tells us that “The House of Representatives on Thursday cleared a $600 billion package of seven spending bills, a small step forward in boosting civilian agency funding next year.The seven-bill “minibus” cleared the House Thursday afternoon by a 219 to 208 vote. The minibus is silent on federal pay for 2022, a silent endorsement of President Joe Biden’s proposed 2.7% raise for civilian employees. * * * The spending package also includes $42 million for the Office of Personnel Management over current levels and allows the agency to stand up an IT working capital fund.” The House is close to completing approval of the twelve appropriations bills. The Senate has not begun to vote on those bills and new federal fiscal year begins in two months, October 1.
  • The Congressional Budget Office released its financial analysis of the President’s budget proposal for the upcoming new federal fiscal year.
  • The ICD10 Monitor explains that yesterday the Centers for Medicare and Medicaid Services finalized four Medicare Part A payment rules which take effect on October 1 — skilled nursing facilities (SNFs), hospices,
  • inpatient rehabilitation facilities (IRFs), and inpatient psychiatric facilities (IPFs). The Monitor’s article summarizes each final rule.
  • The American Hospital Association offers a useful article on approaches to resolving COVID-19 vaccine hesitancy.
  • Fierce Healthcare informs us about insurer comments on the third 2022 Notice of Benefit and Payment Parameters, which proposed changes to the ACA marketplace.

Monday Roundup

Photo by Sven Read on Unsplash

David Leonhardt in the New York Times offered an encouraging article this morning:

When the Kaiser Family Foundation conducted a poll at the start of the year and asked American adults whether they planned to get vaccinated, 23 percent said no.

But a significant portion of that group — about one quarter of it — has since decided to receive a shot. The Kaiser pollsters recently followed up and asked these converts what led them to change their minds. The answers are important, because they offer insight into how the millions of still unvaccinated Americans might be persuaded to get shots, too.

What helps move people from vaccine skeptical to vaccinated? The Kaiser polls point to three main themes.

(The themes apply to both the 23 percent of people who said they would not get a shot, as well as to the 28 percent who described their attitude in January as “wait and see.” About half of the “wait and see” group has since gotten a shot.)

1. Seeing that millions of other Americans have been safely vaccinated. * * *

2. Hearing pro-vaccine messages from doctors, friends and relatives. * * * and

3. Learning that not being vaccinated will prevent people from doing some things.

That’s helpful information for the many vaccine advocates, among us.

Today was a busy day for regulatory action:

  • The Secretary of Health and Human Services renewed for another 90 day period the COVID-19 public health emergency. Earlier this month, the HHS Secretary issued a similar renewal for the Opioid public health emergency which of course predates the COVID-19 emergency. Here’s a link discussing the actions that the federal government can take in response to a public health emergency declaration.
  • The Affordable Care Act regulators issued implementation guidance FAQs part 47 today. As background, “on June 11, 2019, the U.S. Preventive Services Task Force released a recommendation with an “A” rating that clinicians offer [pre-exposure prophylaxis (PrEP)] with “effective antiretroviral therapy to persons who are at high risk of human immunodeficiency virus (HIV) acquisition.” Accordingly, [as required by the ACA, non-grandfathered] plans and issuers must cover PrEP consistent with the USPSTF recommendation without cost sharing [when provided in-network] for plan years (in the individual market, policy years) beginning on or after one year from the issue date of the recommendation (in this case, plan or policy years beginning on or after June 30, 2020).” The FAQs concern the scope of the requisite no cost sharing coverage for this particular service. Affected plans and issuers are allowed sixty days to implement the guidance.
  • The Centers for Medicare and Medicaid Services “proposed Medicare payment rates for hospital outpatient and Ambulatory Surgical Center (ASC) services. The Calendar Year (CY) 2022 Hospital Outpatient Prospective Payment System (OPPS) and ASC Payment System Proposed Rule is published annually and will have a 60-day comment period, which will end on September 17, 2021.” Here is a link to the fact sheet on the proposal. Consistent with the President’s recent executive order on competition, the CMS rule making “proposes to set a minimum CMP of $300/day that would apply to smaller hospitals with a bed count of 30 or fewer and apply a penalty of $10/bed/day for hospitals with a bed count greater than 30, not to exceed a maximum daily dollar amount of $5,500.  Under this proposed approach, for a full calendar year of noncompliance, the minimum total penalty amount would be $109,500 per hospital, and the maximum total penalty amount would be $2,007,500 per hospital.” That should be attention getting if finalized. Also the rule making proposes to backtrack on Trump Administration CMS rules that would phase out inpatient only Medicare requirements for certain medical procedures. The former administration’s goal was to lower costs, but the current administration finds that the former administration did not follow all of the necessary patient safety procedural requirements when making this change.
  • Govexec reports that today “marks the deadline for agencies to submit their finalized return to office plans to the Office of Management and Budget. These plans, which are not intended to be public, will vary by agency.”

The American Hospital Association informs us that “The Centers for Medicare & Medicaid Services will host a national stakeholders call July 22 at 3:30 p.m. ET on the interim final rule, Surprise Billing Part 1, that implements aspects of the No Surprises Act that bans balance billing in certain out-of-network scenarios. The call-in number is 888-455-1397; the participant passcode is 8758359.” Thanks AHA and CMS.

Thursday Miscellany

The FEHBlog realized today that he had neglected to provide this link to Prof. Katie Keith’s comprehensive Health Affairs Blog article on the first No Surprises Act interim final rule. AIS offers the following expert takes on that rule:

Industry experts’ perspectives:

Loren Adler, an associate director at the USC-Brookings Schaeffer Initiative for Health Policy, says that the QPA formula could lock in high rates for providers in some regions, particularly areas where there is a paucity of certain types of providers. He interprets the QPA calculation in the IFR as “a pretty provider-friendly definition.
Ge Bai, Ph.D., an associate professor at Johns Hopkins University’s Carey Business School and Bloomberg School of Public Health, says that it’s important to remember the larger picture — the No Surprises Act could reduce physicians’ revenue in some cases. She says that it could exacerbate physician shortages in areas that pay lower rates than others as physicians move to more lucrative locations.
Going forward, it’s hard to say whether the law and IFR will have inflationary effects on health care prices overall, Adler says. “The biggest piece of that, the determinant, will be the arbitration process,” he adds. He’s waiting to see what happens when the law actually comes into effect and arbitrations begin to take place.

The FEHBlog hopes that this law will not encourage providers to leave health plan networks.

On the COVID-19 front

  • David Leonhardt in the New York Times informs us about “Hopeful News on Delta. The Delta variant is more contagious. It does not appear to be more severe.” “If a new variant is not actually more severe, it doesn’t present a greater threat to a typical person who contracts Covid. Vaccinated people would remain protected. For children too young to be vaccinated, serious Covid symptoms would still be exceedingly rare — rarer than many other everyday risks, like riding in a car — and still concentrated among children with other health problems.”
  • U.S. Surgeon General Dr. Vivek Murthy issued “the first Surgeon General’s Advisory of this Administration to warn the American public about the urgent threat of health misinformation. Health misinformation, including disinformation, have threatened the U.S. response to COVID-19 and continue to prevent Americans from getting vaccinated, prolonging the pandemic and putting lives at risk, and the advisory encourages technology and social media companies to take more responsibility to stop online spread of health misinformation.

On the Aduhelm front:

  • The Wall Street Journal reports that “A pair of large hospitals are declining to administer Biogen Inc.’s new Alzheimer’s treatment, Aduhelm, the latest rupture to emerge from the Food and Drug Administration’s controversial approval of the drug last month. The Cleveland Clinic and Mount Sinai Health System in New York said they wouldn’t administer Aduhelm, which is also called aducanumab, to patients amid a debate about the drug’s effectiveness and whether the FDA lowered its standards in approving the medicine.”
  • Healthcare Dive informs us that “On a morning call with investors [today], UnitedHealth leadership said they were waiting on more information before making a coverage decision regarding Aduhelm, Biogen’s expensive new drug for Alzheimer’s disease priced at an average cost of $56,000 per year.”
  • STAT News tells us that

Normally, if a drug gets FDA approval, that means it has some benefit to patients. But the FDA decided to greenlight Biogen’s controversial drug Aduhelm without that guarantee.

That decision leaves patients, clinicians, and insurance companies in the dark. Under by far the most pressure is Medicare [and FEHB is a close second because FEHB carriers are on the hook for Medicare eligible annuitants drug coverage (see Wednesday’s post)}, since most patients eligible for the pricey drug have insurance through the taxpayer-funded program. Officials with the program just this week started the process for figuring out how Medicare will cover the drug, which will take months.

Some experts and stakeholders, including the influential Alzheimer’s Association, have called on Medicare to activate a rarely used regulatory tool to get more data about how well the drug works. (The FDA has also said Biogen must study whether Aduhelm slows down patients’ cognitive decline, but the drug maker has said it doesn’t have to report its results for another nine years.)

The tool, called a Coverage with Evidence Development, would mean Medicare would only cover Aduhelm for patients who enroll in clinical studies. The process has the potential to create real-world data that could help patients, physicians, and payers navigate unprecedented and difficult decisions.

In miscellaneous news

  • Healthcare Dive reports that “UnitedHealth Group handily beat Wall Street expectations for earnings and revenue in the second quarter, reporting revenue up 15% year over year to $71.3 billion, leading the Minnesota-based healthcare behemoth to increase its full-year guidance following the results.”
  • The Department of Health and Human Services announced that “more than two million people have signed up for health coverage during the Biden-Harris Administration’s 2021 Special Enrollment Period (SEP), which opened on February 15, 2021 as the country grappled with the pandemic, and will conclude on the extended deadline August 15, 2021.” * * * “The report also shows that of the new and returning consumers who have selected a plan since April 1, 1.2 million consumers (34%) have selected a plan that costs $10 or less per month after the American Rescue Plan’s (ARP) premium reductions.” The President wants Congress to make permanent this two year long premium reduction program.
  • Fierce Healthcare adds that “Senate Democrats announced late Tuesday the framework for a $3.5 trillion infrastructure package that will expand Medicare to offer dental, hearing and vision benefits.”