Midweek update

Midweek update

Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

From the Omicron and siblings front —

The Wall Street Journal reports

The Biden administration has agreed to pay $3.2 billion for 105 million doses of Pfizer Inc.’s Covid-19 vaccine.

The deal would provide supplies for the federal government’s planned fall booster campaign, which administration officials are devising to blunt a potential wave in cases, possibly driven by variants of the Omicron strain now spreading across the U.S.

Under the deal, the federal government would have the option to buy 195 million additional doses, the Health and Human Services Department said Wednesday. Pfizer, which developed and makes the vaccine with partner BioNTech SE, would make whatever type of vaccine federal health regulators decide should be featured in the fall campaign.

The American Hospital Administration informs us

The Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response and Food and Drug Administration this week extended the shelf life for certain refrigerated lots of the COVID-19 combination monoclonal antibody therapies REGEN-COV and Evusheld. They extended the shelf life for REGEN-COV from 24 months to 30 months and the shelf life for Evusheld from 18 months to 24 months. FDA last year authorized the therapies for emergency use to prevent COVID-19 in certain adults and children. REGEN-COV is not currently authorized in any U.S. region because it is unlikely to be effective against the omicron variant and subvariants.

Health IT Analytics tells us “The National Institutes of Health’s (NIH) All of Us Research Program has announced that health data from 20,000 people who have had SARS-CoV-2 is now available to researchers in the US, expanding the program’s dataset to encourage the study of long COVID, social determinants of health (SDOH), and health disparities.”

Also, from the SDOH front, MedPage Today informs us

Maternal mortality rates substantially increased during the COVID-19 pandemic, according to a study using data from the National Center for Health Statistics.

After March 2020, maternal deaths increased by 33.3%, which was higher than the 22% overall excess death estimate expected to result from the pandemic, reported Marie Thoma, PhD, of the University of Maryland in College Park, and Eugene Declercq, PhD, of Boston University.

The rate of maternal deaths before the pandemic was 18.8 per 100,000 live births, which increased to 25.1 per 100,000 live births during the pandemic, the authors noted in a research letter published in JAMA Network Open. * * *

The largest increases were seen in Hispanic and Black women, which was in line with maternal mortality rates before the pandemic. Hispanic women saw a relative change of 74.2% (8.9 deaths per 100,000 live births), and Black women saw a 40.2% relative change (16.8 deaths per 100,000 live births), while white women saw a 17.2% relative change (2.9 deaths per 100,000 live births).

From the monkeypox front, the Department of Health and Human Services announced

an enhanced nationwide vaccination strategy to mitigate the spread of monkeypox.  The strategy will vaccinate and protect those at-risk of monkeypox, prioritize vaccines for areas with the highest numbers of cases, and provide guidance to state, territorial, tribal, and local health officials to aid their planning and response efforts.

Under the strategy, HHS is rapidly expanding access to hundreds of thousands of doses of the JYNNEOS vaccine for prophylactic use against monkeypox in areas with the highest transmission and need, using a tiered allocation system. Jurisdictions can also request shipments of the ACAM2000 vaccine, which is in much greater supply, but due to significant side effects is not recommended for everyone.  * * *

The Advisory Committee on Immunization Practices currently recommends vaccination for those at high risk following a confirmed monkeypox exposure. Given the large number of contacts and difficulty in identifying all contacts during the current outbreak, vaccine will now be provided to individuals with confirmed and presumed monkeypox exposures. This includes those who had close physical contact with someone diagnosed with monkeypox, those who know their sexual partner was diagnosed with monkeypox, and men who have sex with men who have recently had multiple sex partners in a venue where there was known to be monkeypox or in an area where monkeypox is spreading.

The American Hospital Association adds

CDC yesterday activated its Emergency Operations Center to monitor and coordinate the emergency response to monkeypox and mobilize additional CDC personnel and resources. The agency has expanded testing capacity for the virus since May 18, when the first U.S. case in the global outbreak was confirmed, to include up to 78 state public health laboratories and five commercial laboratory companies. As of June 28, 306 U.S. monkeypox cases have been reported

From the Dobbs case front

  • CNBC reports “CVS is removing its earlier purchase limit on emergency contraceptive pills. The chain said that ‘sales have since returned to normal and we’re in the process of removing the purchase limits.'”
  • HHS’s Office for Civil Rights announced “new guidance to help protect patients seeking reproductive health care, as well as their providers.”

In general, the guidance does two things:

1. addresses how federal law and regulations protect individuals’ private medical information (known as protected health information or PHI) relating to abortion and other sexual and reproductive health care – making it clear that providers are not required to disclose private medical information to third parties; and

2. addresses the extent to which private medical information is protected on personal cell phones and tablets, and provides tips for protecting individuals’ privacy when using period trackers and other health information apps.

According to recent reports, many patients are concerned that period trackers and other health information apps on smartphones may threaten their right to privacy by disclosing geolocation data which may be misused by those seeking to deny care. * * *

The guidance on the HIPAA Privacy Rule and Disclosures of Information Relating to Reproductive Health Care may be found at https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/phi-reproductive-health/index.html.

The guidance on Protecting the Privacy and Security of Your Health Information When Using Your Personal Cell Phone or Tablet may be found at https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/cell-phone-hipaa/index.html.

From the FDA front, BioPharma Dive identifies five FDA decisions to watch in the third quarter of 2022 which starts on Friday.

From the Affordable Care Act front, the Internal Revenue Service released a draft of the 2022 Form 1095-B which FEHB and other health plans offering minimum essential coverage must make available to their enrollees.

Monday Roundup

Photo by Sven Read on Unsplash

From Capitol Hill, Federal News Network discusses the federal employee pay raise angles presented by the House financial service and general appropriations bill which cleared the House Appropriations Committee last Friday. Federal News Network indicates that the bill leaves the door open for the Senate to also accept the President’s proposed 2023 4.6% pay raise for federal employees and the military.

From the Dobbs case front, Govexec.com reports

President Joe Biden announced two actions immediately after the ruling: one directing the Department of Health and Human Services to safeguard access to contraception and medication abortion, and another protecting travel for medical appointments.

To those ends,

  • Govexec tells us that OPM today confirmed that its policy allowing federal employees to apply sick time to travel out of state remains in effect after the high court struck down Roe v. Wade, and
  • The Department of Health and Human Services (HHS) announced that a meeting was held today between Affordable Care Act regulators, including the HHS and Labor Department Secretaries, and health plan executives to emphasize the importance of full compliance with the ACA’s contraceptive coverage with no cost-sharing mandate when delivered in-network. The ACA regulators also issued a letter to health plans making the same point.

The FEHBlog ran across this NPR Shots article which explains that the Plan B or morning-after pill is considered a contraceptive and not an abortion drug. The Wall Street Journal informs us

Some of the nation’s biggest retailers are rationing over-the-counter emergency contraceptive pills as demand spikes following the Supreme Court ruling overturning a constitutional right to abortion.CVS Health Corp.,  Walmart Inc., and Rite Aid Corp. were limiting purchases of the pills, which were in short supply or out of stock Monday morning on major retailer websites. CVS and Rite Aid were limiting purchases to three. Walmart had some pills available without limits, but only in cases where they wouldn’t ship until next month. Pills available this week were limited to four or six.

From the Omicron and siblings and monkeypox front

  • Govexec reports on a U.S. Court of Appeals for the Fifth Circuit decision order rehearing a federal employee vaccine mandate case which upheld the mandate on lack of plaintiffs’ standing to challenge the mandate. The mandate nevertheless has remained on hold while the case winds it way through the appellate court.
  • USA Today reports on when and how to access the monkeypox vaccine.

From the Medicare front, HHS announced

a new model aimed at improving cancer care for Medicare patients and lowering health care costs. CMS’ Center for Medicare and Medicaid Innovation (Innovation Center) designed the Enhancing Oncology Model (EOM) to test how to improve health care providers’ ability to deliver care centered around patients, consider patients’ unique needs, and deliver cancer care in a way that will generate the best possible patient outcomes. The model will focus on supporting and learning from cancer patients, caregivers, and cancer survivors, while addressing inequities and providing patients with treatments that address their unique needs.

From the reports and studies department —

  • The next issue of Health Affairs offers a bevy of articles on Type 2 diabetes and pre-diabetes which are available at this link.
  • The Congressional Budget Office has made available examples of the work performed by its Health Analysis Division.
  • HealthDay reports “More than 18 million Americans have now survived cancer, a new report shows. The American Cancer Society (ACS) and the U.S. National Cancer Institute collaborated on the report to estimate cancer prevalence and help public health officials better serve survivors.”
  • mHealth Intelligence calls our attention to a telehealth-oriented  Healthcare Experience Report: 2022 released by Zocdoc. The FEHBlog was pleased to read “Mental health continues to hold a place of dominance in telehealth. In May of 2020, 2021, and 2022, the percentage of mental health visits that occurred virtually was 74 percent, 85 percent, and 87 percent, respectively.” Hub and spoke telehealth, e.g, Teladoc, brings mental health care in-network thereby lowering benefit costs while improving access to care.

Weekend update

Photo by Dane Deaner on Unsplash

From Capitol Hill —

The Senate is on a State work break for the next two weeks which encompasses Independence Day. The House of Representatives will be engaged in Committee business this week through Thursday. Then the House will be on District work break through the end of the following week.

The House Oversight and Reform Committee is holding a hearing tomorrow on an important topic: “Examining the 2022 National Drug Control Strategy and the Federal Response to the Overdose Crisis.”

On Friday, the House Appropriations Committee approved

the fiscal year 2023 Financial Services and General Government bill on a 31 to 22 vote. * * *

The following amendments to the bill were adopted by the full Committee:

Rep. Quigley – The manager’s amendment makes technical and noncontroversial changes to the bill and report. The amendment was adopted by voice vote.

Rep. Stewart #3 – This amendment prohibits the government’s use of cloud computing platforms unless they prevent child exploitation images. The amendment was adopted by voice vote.

A summary of the bill is here. The text of the draft bill is here. The bill report, before the adoption of amendments in full Committee, is here

This bill includes FEHB and OPM funding.

It occurred to the FEHBlog over the weekend that on Friday he did not explain how the Supreme Court’s Dobbs decision overruling Roe v. Wade impacts the FEHB Program. The short answer in the FEHBlog’s opinion is that it has no impact.

Under the Hyde Amendment whose requirements have been applied to the FEHB via annual appropriations bills for decades, FEHB Program coverage of abortions is limited to abortions in cases of rape, incest, or endangerment of the mother’s life. Federal courts of appeals uniformly have held that the Hyde Amendment preempts more restrictive State abortion limitations. E.g., Planned Parenthood Affiliates v. Engler, 73 F.3d 654 (6th Cir. 1996) (citing precedential authorities).

From the Omicron and siblings front —

Nature reports

The BA.4 and BA.5 subvariants are spiking globally because they can spread faster than other circulating variants — mostly BA.2, which caused a surge in cases at the beginning of the year. But so far, the latest Omicron variants seem to be causing fewer deaths and hospitalizations than their older cousins — a sign that growing population immunity is tempering the immediate consequences of COVID-19 surges.

Nature explores what the rise of BA.4 and BA.5 means for the pandemic.

The FEHB agrees that the complete Nature article is worth reading.

The Wall Street Journal informs us

Pfizer Inc. and BioNTech SE vaccines modified to target the Omicron variant produced a significantly larger immune response than the companies’ currently available vaccine in a study, they said.

A modified booster shot targeting Omicron specifically increased neutralizing antibody levels 13.5 to 19.6 times higher than the current shot in study volunteers a month after administration, depending on the dose, the companies said Saturday. * * *

The results, coming after Moderna Inc. also found its Omicron-targeting booster produced a stronger immune response, suggest possible benefit to modifying the shots to improve protection against an evolving virus.

The Journal adds that the Food and Drug Administration is considering whether to give emergency use authorization to the Omicron-oriented boosters for fall 2022. Based on the Nature article, it appears that Omicron will still be with us then.

Fortune identifies seven things doctors who treat long Covid want people to know.

From the Monkeypox front, Bloomberg Prognosis tells us

The World Health Organization opted against calling the recent monkeypox outbreak a public health emergency of international concern.

The outbreak is “clearly an evolving threat,” the WHO said in a statement Saturday, though it doesn’t constitute an international public health emergency “at this moment.” An emergency committee convened on Thursday to discuss the outbreak.

“What makes the current outbreak especially concerning is the rapid, continuing spread into new countries and regions and the risk of further, sustained transmission into vulnerable populations including people that are immunocompromised, pregnant women and children,” according to the statement. “It requires our collective attention and coordinated action now to stop the further spread of monkeypox virus.”

NPR Shots expresses concern that U.S. testing program for this disease is inadequate.

For many of the [201] confirmed cases, health officials don’t know how the person caught the virus. Those infected haven’t traveled or come into contact with another infected person. That means the virus is spreading in some communities and cities, cryptically. 

“The fact that we can’t reconstruct the transmission chain means that we are likely missing a lot of links in that chain,” Jennifer Nuzzo, an epidemiologist at Brown University, says. “And that means that those infected people haven’t had the opportunity to receive medicines to help them recover faster and not develop severe symptoms. 

“But it also means that they’re possibly spreading the virus without knowledge of the fact that they’re infected,” she adds.

In other words: “We have no concept of the scale of the monkeypox outbreak in the U.S.,” says biologist Joseph Osmundson at New York University. “

NPR explains that the monkeypox testing process is much too cumbersome and the CDC hopes to have the process streamlined “sometime in July.”

Meanwhile, Precision Vaccines reports

New influenza vaccine effectiveness data presented at the U.S. CDC’s June 22, 2022 meeting of the Advisory Committee on Immunization Practices (ACIP) show flu shots worked better during 2021 – 2022 than initially reported.

Published on June 23, 2022, this ACIP data shows flu shots reduced the risk of influenza illness by about 35% among vaccinated people.

Data from October 4, 2021, through April 30, 2022, showed that flu vaccines reduced people’s risk of mild to moderate flu illness caused by H3N2 flu viruses—the most common flu viruses this season—by about one-third overall. * * *

Also, at the meeting, ACIP voted in favor of a preferential recommendation for certain flu vaccines over others for adults 65 years and older in the United States. 

The ACIP voted to preferentially recommend higher-dose flu vaccines (Fluzone High-Dose vaccine and Flublok recombinant vaccine) or adjuvanted flu vaccine (Fluad vaccine) over standard-dose unadjuvanted flu vaccines.

And if one of these vaccines is unavailable at the time of administration, people in this age group should get a standard-dose flu vaccine instead. 

From the health information technology front, Health Data Management calls out attention to the following

  • “In a [very sensible] letter to Department of Health and Human Services Secretary Xavier Becerra, several healthcare standards organizations are calling for streamlining and making more predictable the process for submitting attachments as well as modernizing existing rules to improve patient care and reduce burdens on clinicians.”
  • New legal requirements for providers to give an estimated cost of patients’ medical services will be difficult to meet, particularly when multiple organizations are involved in a patient’s care, according to WEDI, the Workgroup on Electronic Data Interchange. Meeting the requirements of the No Surprises Act, which was included as part of a Consolidated Appropriations Act passed late in 2020, will be challenging because there is no standardized process to enable the exchange of cost information among facilities, WEDI notes.”
  • While healthcare organizations see the prevailing trend of increasing patient consumerism, the ability to give patients opportunities to schedule their own appointments is lagging. Many organizations have adopted some capabilities for self-scheduling, according to new research from the Center for Connected Medicine (CCM), yet the use of these tools remains low [because] scheduling solutions lack the right algorithms and that organizations lack standardized scheduling templates across appointment types.”

In particular the second bullet strikes a chord with the FEHBlog as he has pointed out that Congress made a huge mistake by failing add the provider’s good faith estimate and the health plan’s advance explanation of benefits to the list of HIPAA standard transactions.

Happy First Day of Summer 2022

Thanks to Aaron Burden for sharing their work on Unsplash.

From Capitol Hill, the Hill reports

The Senate voted 64 to 34 Tuesday evening to advance an 80-page gun safety bill to strengthen background check requirements for gun buyers under 21, provide funding to states to administer red flag laws and to provide billions of dollars in new federal funding for mental health services.  * * *

Senate Majority Leader Schumer (D-N.Y.) said a successful initial procedural vote would set the bill up to pass by the end of the week.  

Last week, a House Appropriations subcommittee approved the Fiscal Year 2023 Financial Services and General Government Appropriations bill, which funds OPM and the FEHB Program. The accompanying bill summary points out

  • Office of Personnel Management (OPM) – The bill includes $448 million, an increase of $75 million above the FY 2022 enacted level, for OPM to manage and provide guidance on Federal human resources and administer Federal retirement and health benefit programs.
  • Fosters equality for women and men: Eliminates provisions preventing the FEHBP from covering abortion services.

The House Appropriations Committee will mark up this bill at a meeting scheduled for Friday, June 24.

The U.S. Supreme Court today issued a 7-2 decision holding that the Medicare Secondary Payer law does not permit healthcare providers to make disparate impact claims against health plans. This decision protects ERISA and FEHB Program plans against costly litigation. Fierce Healthcare and Health Payer Intelligence also report on the decision.

From the Omnicron and siblings front —

MedPage Today informs us

Most people who have been infected with COVID-19 in the U.S. in the past couple of months likely had the BA.2 or BA.2.12.1 variant, both lineages of the original Omicron strain of SARS-CoV-2.

Now, BA.4 and BA.5 are here, and they’re starting to make up a larger proportion of U.S. cases.

So if someone was recently infected with a BA.2 lineage, are they mostly protected against reinfection with BA.4 or BA.5?

Probably not, infectious disease experts say.

“It’s expected that there’s probably not much cross-protection between them,” Amesh Adalja, MD, an infectious disease physician at the Johns Hopkins Center for Health Security in Baltimore, told MedPage Today.

The American Hospital Association tells us

More than 1 million prescriptions for the COVID-19 antiviral pills Lagevrio and Paxlovid were dispensed between late December 2021 and May 2022, but dispensing rates were lowest in the most socially and economically disadvantaged communities, according to a study released today by the Centers for Disease Control and Prevention. In a separate study of electronic health records from Kaiser Permanente Southern California over the period, fewer than 1% of patients aged 12 and older who received Paxlovid to treat mild-to-moderate COVID-19 had a COVID-19-related hospitalization or emergency department visit in the next five to 15 days. CDC said the studies “highlight the importance of ensuring access to oral antiviral medicine in treating COVID-19, a key strategy in preventing hospitalization and death.”

Speaking of hospitals, Beckers Hospital Review reports

Healthgrades has recognized 399 hospitals as recipients of its 2022 Outstanding Patient Experience Award, the organization said June 21. This represents the top 15 percent of hospitals in the U.S. for patient experience.  * * * Healthgrades has recognized 399 hospitals as recipients of its 2022 Outstanding Patient Experience Award, the organization said June 21. This represents the top 15 percent of hospitals in the U.S. for patient experience.  * * * View the full list of recipients here

From the Rx coverage front —

  • The Food and Drug Administration released one of its news roundups today.
  • Per Stat News, a group of researchers writing in the Annals of Internal Pharmacy used Mark Cuban’s online pharmacy pricing to puncture Medicare Part D’s pricing on generic drugs.
  • Per Fierce Healthcare, CVS Health is expanding its Project Health program to Richmond, Virginia and Las Vegas. “The healthcare giant announced Tuesday that it will hold 72 events dedicated to seniors and children this year. It is also adding four new mobile units in 2022.”
  • Per Healthcare Dive, Walgreens “has partnered with managed care company Buckeye Health Plan in Ohio to open new Health Corner locations in five of the state’s northeast neighborhoods this summer. * * * About 2.3 million patients will have access to Health Corner services across 60 locations in Ohio, California and New Jersey by the summer’s end, Walgreens said on Tuesday. By the end of this year, Walgreens expects to increase the number of Health Corners from 55 to about 100, including the new Ohio locations.”

From the interoperability and telehealth fronts

  • Epic, the largest purveyor of electronic health record systems in the U.S., announced “its plan to join a new health information exchange framework to improve health data interoperability across the country. The Trusted Exchange Framework and Common Agreement (TEFCA) will bring information networks together to help ensure that all people benefit from complete, longitudinal health records wherever they receive care. In the future, TEFCA will expand to support use cases beyond clinical care, such as public health.” That’s a big boost for TEFCA, which will serve as the backbone for the nation’s EHR systems.
  • AHRQ offers research on telehealth for women’s preventive healthcare services.

Finally, STAT News reports

President Biden will soon nominate Arati Prabhakar, a physicist and former DARPA director, to serve as his next top science adviser, the White House announced on Tuesday.

If confirmed by the Senate, Prabhakar would replace the genomics researcher Eric Lander, who resigned as the head of the White House science office in February amid a workplace-bullying scandal.

The new post would be Prabhakar’s third tour as head of a federal science office. She ran DARPA, the high-stakes military research agency, from 2012 to early 2017, and served as director of the National Institute of Standards and Technology in the 1990s.

Holiday Monday Roundup

Photo by Sven Read on Unsplash

Happy Juneteenth (observed)! Here are a few items that came to the FEHBlog’s attention today

From the Omicron and siblings front —

The New York Times informs us that “Despite Another Covid Surge, Deaths Stay Near Lows. Most Americans now carry some immune protection, experts said, whether from vaccines, infection or both.” Amen to that.

While the Food and Drug Administration has given emergency use authorization to Moderna’s vaccine for ages 6 to 17, the Centers for Disease Control has not yet ratified that decision so Pfizer’s vaccine remains the only vaccine available to that age group for now.

From the unusual viruses front, STAT News reports

When previously healthy little kids started showing up in hospitals with failing livers last fall and this spring, startled doctors and public health authorities didn’t know what was behind what they were seeing. They also didn’t know if what they were seeing was new. * * *

Now scientists at the Centers for Disease Control and Prevention have come up with some estimates for the normal rate of this condition, at least in the United States. Their findings, published earlier this week in the online journal Morbidity and Mortality Weekly Report, may come as a surprise.

Their research suggests there has not been an increase in cases of pediatric hepatitis of unknown origin, at least in the United States. Nor has there been a rise in the number of pediatric liver transplants, which a portion of these children have needed. Likewise, the rate of detections of infections caused by adenovirus 41 — a stomach bug virus that has been implicated as a potential trigger of these hepatitis cases — has not changed over time, the CDC scientists reported. * * *

With rates unchanged since before the Covid-19 pandemic, a theory espoused by scientists from Israel — that this is some sort of post-Covid condition — becomes harder to argue.

“It doesn’t mean that Covid still can’t have some collateral role with all of this. But I think these kind of data helps support that that’s probably not the cause,” explained veteran epidemiologist Michael Osterholm, who was not involved in the CDC work.

That’s encouraging news.

The Society for Human Resource Management tells us about its 2022 Employee Benefits Survey.

“Employer rankings of the importance of benefits shifted drastically in 2020 as they made pandemic-inspired adjustments, but these rankings have returned to an order like that seen pre-pandemic as businesses regain a semblance of normal operations,” said Daniel Stunes, senior researcher at SHRM.

Significantly, however, “all benefit types were rated by employers as more important to offer today than before the COVID-19 pandemic,” Stunes said, reflecting an increased appreciation for the role benefits play in fostering employee well-being and in attracting and keeping talent in a tight labor market.

Friday Stats and More

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 weekly chart of new Covid cases from the 27th week of 2021 through the 24th week of 2022:

While the CDC did not publish its weekly Covid statistical review this week, the FEHBlog can tell you that the daily new Covid hospitalization average is 4,321 for the week ended June 15, 2022. That average is 4.7% higher than the previous week.

Here’s the FEHBlog’s weekly chart of new Covid deaths for the same period as new cases:

New cases and deaths are both stable. MedPage Today adds

About 4.5% of people who became infected with SARS-CoV-2 when Omicron was the dominant strain experienced long COVID symptoms, compared with 10.8% who became infected during the Delta period, reported Claire Steves, PhD, of King’s College London in England, and co-authors.

Overall odds of long COVID were about 20% to 50% less during the Omicron era — defined as December 2021 to February 2022 in this study — depending on age and time since vaccination, the researchers wrote in a letter to The Lancet.

For more information, Science discusses clues to long Covid.

Here’s the FEHBlog’s weekly chart of new Covid vaccinations distributed and administered from the 51st week of 2020, when the Covid vaccination era began and the current 24th week of 2022.

Over 100,000 people aged 12 and older have received at least one booster.

The Wall Street Journal adds.

Vaccine advisers to the Centers for Disease Control and Prevention discussed Friday the merits of Covid-19 shots now authorized for children as young as 6 months. * * *

The committee is scheduled to discuss further the case for recommending giving the Pfizer-BioNTech and Moderna shots to young children, and then vote on the matter Saturday.

The Biden administration has said the shots could be made available as soon as Monday, should regulators give their assent.

The federal government has begun shipping millions of doses to doctor’s offices, children’s hospitals and pharmacies, President Biden said after the FDA’s authorizations.

From the Rx coverage front, STAT News and Medical Economics update us on the federal government’s investigation of prescription benefit managers. Notably, STAT News reports

Amid intensifying scrutiny of pharmacy benefit managers, a group of House Republicans is urging the U.S. Government Accountability Office [via a June 17 letter] to investigate the role these controversial middlemen play in the opaque pharmaceutical pricing system.

From the Federal Trade Commission front, Healthcare Dive tells us that the FTC has obtained several victories over the past week in its legal challenges to hospital system mergers in New Jersey, Rhode Island, and Utah.

From the No Surprises Act front, reginfo.gov informs us that on June 15, the Office of Information and Regulatory Affairs received for review the NSA regulators’ final rule on the independent dispute resolution process. OIRA review is the last step before the rule is published in the Federal Register. The healthcare provider associations mounted a successful legal challenge to the interim final rule’s treatment of the qualifying payment amount as a rebuttable presumption at the arbitration stage.

From the HIPAA standard transactions front, a Health and Human Services workgroup has issued guidance on how payers can help providers associate electronic explanations of benefits with electronic payments.

From the U.S. healthcare front, Kaiser Health News and a WTW study delve into the widespread related problems of medical debt and deferred care. On the bright side, the National Institutes of Health reports that flexible work schedules and paid sick leave improves employee access to healthcare.

Monday Roundup

Photo by Sven Read on Unsplash

From the Omicron and siblings front, the Wall Street Journal reports

A Covid-19 vaccine developed by Sanofi SA and GSK PLC to target the Beta strain of the virus produced a stronger antibody response against variants of Omicron when given as a booster compared with certain first-generation shots, two studies have found.

The results are the latest indication that tweaking vaccines can nudge antibody responses in the direction of new variants, possibly helping to shore up immunity as the virus mutates. The study results may also provide an opportunity for Sanofi and GSK, two vaccine giants that were late to develop Covid-19 immunizations, to play a role in providing booster shots.

What’s more, according to the Journal

A panel of advisers to the Food and Drug Administration is set to meet Tuesday [June 14] to consider whether use of Moderna Inc.’s Covid-19 vaccine should be expanded to include children ages 6 through 17.

The advisory committee is expected to vote Tuesday afternoon on whether the benefits of vaccinating children in this age group outweigh the risks. The FDA will consider the vote in making a final decision on whether to clear the vaccine for use in children 6 years and older.

An FDA authorization could come within days. It would open the use of Moderna’s vaccine to children for the first time in the U.S., and give anyone still intending to inoculate their children 6 years and older against Covid-19 a second option.

Moderna’s vaccine has been authorized for use in adults 18 years and older since late 2020, while use of the other leading Covid-19 vaccine, from Pfizer Inc. and BioNTech SE, was expanded to anyone 5 and older last year.

From the FTC investigation front, FierceHealthcare updates us on the recently launched FTC investigation of the six largest PBMs. In other FTC news, Healthcare Dive tells us

** UnitedHealth and LHC Group have been hit by a request for additional information on their acquisition from the Federal Trade Commission, as regulators take an increasingly active role in overseeing healthcare M&A.

** The second request extends the waiting period the FTC has to challenge the deal. UnitedHealth agreed to acquire home health and hospice provider LHC for $5.4 billion in March.

** https://www.healthcaredive.com/news/regulators-unitedhealth-lhc-request-merger/625343/?utm_source=Sailthru&utm_medium=email&utm_campaign=Issue:%202022-06-13%20Healthcare%20Dive%20%5Bissue:42394%5D&utm_term=Healthcare%20DiveIn a filing with the SEC on Friday, the companies said they have been complying with regulators and will continue to do so.

Speaking of home health care, Home Health News discusses Aetna’s interest in the topic.

Aman Gill, Aetna’s director of product strategy and innovation, told Home Health Care News last month that a home health acquisition was “on the table” for the company. 

This past week, at HHCN’s VALUE event, Aetna CMO Dr. Kyu Rhee reiterated the company’s commitment to the home as a setting of care. He also explained how care delivery has changed over the course of the last few years.

“We’ve been committed to home health and virtual care during the pandemic,” Rhee said. “And in our Medicare program, we’ve delivered tens of thousands of healthy at-home visits as well. … So my challenge to us as we think about the opportunity we have now and the next stage of this pandemic is: Are we going to persist in those values and make sure that the system delivers on those values, that hopefully we’ve learned over the last couple of years?”

From the Rx coverage front, the Food and Drug Administration announced

the [agency approved Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata, a disorder that often appears as patchy baldness and affects more than 300,000 people in the U.S. each year. Today’s action marks the first FDA approval of a systemic treatment (i.e. treats the entire body rather than a specific location) for alopecia areata.

“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” said Kendall Marcus, M.D., director of the Division of Dermatology and Dentistry in the FDA’s Center for Drug Evaluation and Research. “Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata.”

The drug initially was FDA-approved for the treatment of rheumatoid arthritis in 2018.

From the HIPAA Privacy Rule front, the U.S. Department of Health and Human Services (HHS), through its Office for Civil Rights (OCR), announced

issuing guidance on how covered health care providers and health plans can use remote communication technologies to provide audio-only telehealth services when such communications are conducted in a manner that is consistent with the applicable requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security, and Breach Notification Rules, including when OCR’s Notification of Enforcement Discretion for Telehealth – PDF is no longer in effect. * * *

The Guidance on How the HIPAA Rules Permit Health Plans and Covered Health Care Providers to Use Remote Communication Technologies for Audio-Only Telehealth may be found at: https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/hipaa-audio-telehealth/index.html.

Friday Stats and More

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 weekly chart of new Covid cases from the 27th week of 2021 through the 23rd week of 2022.

The CDC’s weekly review of its Covid statistics observes “As of June 8, 2022, the current 7-day moving average of daily new cases (109,032) increased 8.0% compared with the previous 7-day moving average (100,916).”

Here’s is the CDC’s latest weekly report of new Covid hospitalizations:

The CDC’s weekly review notes “The current 7-day daily average for June 1–7, 2022, was 4,127. This is an 8.0% increase from the prior 7-day average (3,820) from May 25–31, 2022.”

Here’s the FEHBlog’s weekly chart of new Covid deaths over the same period as new cases:

The CDC’s weekly review adds “The current 7-day moving average of new deaths (306) has increased 18.6% compared with the previous 7-day moving average (258).” Over 2/3s of the U.S. population is now fully vaccinated.

Here’s the FEHBlog weekly chart of Covid vaccinations distributed and administered from the beginning of the vaccination era at the 51st week of 2020 through the 23rd week of 2022:

The CDC’s weekly review states “As of June 8, 2022, the 7-day average number of administered vaccine doses reported (by date of CDC report) to CDC per day was 290,078, a 15.6% decrease from the previous week.”

The American Hospital Administration adds

An initial 10 million doses of COVID-19 vaccine are available for children under age 5 if the Food and Drug Administration authorizes and the Centers for Disease Control and Prevention recommends the Pfizer and Moderna vaccines for children in this age group, Assistant Secretary for Preparedness and Response Dawn O’Connell said yesterday during a White House briefing.

FDA’s vaccine advisory committee will meet June 14-15 and the CDC’s advisory committee June 17-18 to consider whether to authorize and recommend the vaccines for this age group, after which the agencies will issue their respective decisions.

“It will take some time to position these vaccines across the country, and vaccinations can’t begin until CDC has made its decision,” O’Connell said. “But we also know that many parents have been waiting for a long time, so we will be working 24/7 until every dose is shipped and delivered.”

The Administration last week opened pre-ordering of doses for states, tribes, territories and other partners, and estimates that 85% of children under 5 live within 5 miles of a potential vaccination site, she said.

The CDC’s weekly review sums things up as follows:

As of June 9, 2022, there are 314 (9.75%) counties, districts, or territories with a high COVID-19 Community Level, 1,052 (32.67%) counties with a medium Community Level, and 1,854 (57.58%) counties with a low Community Level. This represents a small (+2.20 percentage points) increase in the number of high-level counties, a moderate (+9.57 percentage points) increase in the number of medium-level counties, and a corresponding (−11.77 percentage points) decrease in the number of low-level counties. Fifty-two (100%) of 52 jurisdictions* had high- or medium-level counties this week.

To check your COVID-19 Community Level, visit COVID Data Tracker. To learn which prevention measures are recommended based on your COVID-19 Community Level, visit COVID-19 Community Level and COVID-19 Prevention.

From the unusual viruses front, the American Hospital Association tells us

The Centers for Disease Control and Prevention today reported over 1,300 monkeypox cases globally, including 45 in the United States. While no deaths have been reported and the overall risk to the U.S. public remains low, officials encouraged clinicians to review the CDC’s latest guidance and individuals to talk with their health care provider if they develop symptoms or need to get tested.

According to CDC, monkeypox spreads through direct contact with an infected person’s body fluids, sores or materials that have touched them, such as clothing or linens. It may also spread through respiratory secretions when people have close, face-to-face contact.

Smallpox vaccines are effective at protecting people against monkeypox when given before exposure and may also help prevent the disease or make it less severe. According to CDC, the Strategic National Stockpile currently holds about 72,000 doses of JYNNEOS smallpox vaccine and will soon receive an additional 300,000 doses from the manufacturer. The U.S. also has ordered another 500,000 doses for delivery later this year. In addition, the SNS holds over 100 million doses of an older smallpox vaccine (ACAM2000). 

From the electronic health record front, Beckers Hospital News reports

Oracle’s primary mission is improving the complex healthcare system with technology, according to Larry Ellison.

The chair, co-founder and chief technology officer of Oracle said in a June 9 virtual public presentation the company plans to vastly improve care delivery, outcomes and public health policy while also lowering costs. Oracle acquired Cerner in a $28.4 billion transaction earlier this week and has plans to modernize the platform, taking it from a documentation and billing system to a complete source of information about an individual’s healthcare. The EHR would also have virtual care capabilities, be interoperable and expand clinical trial accessibility.

“Together, Cerner and Oracle have all the technology required to build a revolutionary new health management information system in the cloud,” Mr. Ellison said. “That system will deliver much better information to healthcare professionals. Better information will fundamentally transform healthcare.”

Oracle aims to build a unified database for patient information, similar to the unified financial database with credit information, accessible to healthcare providers and public health officials. The database would have anonymized data from hospitals, clinics and providers across the U.S. and provide up-to-the-minute information about patients’ personal health as well as public health statistics, such as the number of people hospitalized with COVID-19 or available hospital beds in a particular state.

“We’re building a system where the health records, all American citizens’ health records, not only exist at the hospital level, but they are all in a unified national healthcare database,” Mr. Ellison said. “The national database solves the data electronic health record fragmentation problem.”

Aim high. Assuming security and privacy challenges can be addressed, such a database could be a public health game changer.

Thursday Miscellany

Photo by Josh Mills on Unsplash

From our Nation’s capital, the New York Times reports,

White House officials said on Wednesday that they would have to repurpose federal Covid-19 funds meant for coronavirus tests and protective equipment in order to supply more antiviral pills and vaccines, after so far failing to persuade Congress to pass a new pandemic relief package.

Roughly $10 billion from Department of Health and Human Services funds will be rerouted, around half of it to purchase vaccines for Americans ahead of a possible fall or winter wave of virus cases, when an updated shot may be needed, according to one White House official. The other half will go mostly to purchasing 10 million courses of Paxlovid, the antiviral treatment made by Pfizer that has been shown to substantially reduce the severity of Covid-19 in high-risk people, the official said. Around $300 million will be spent on another kind of treatment, monoclonal antibodies.

Also from the Omnicron and siblings front, a friend of the FEHBlog, journalist Theresa Defino, points out

Today and tomorrow NIH’s Advisory Committee to the Director is holding its first of two annual meetings. Today Dr. Fauci gave a presentation on Covid and Dr. Walter Koroshetz, director of the National Institute of Neurological Disorders and Stroke, spoke on recovery from Covid.

The most interesting comments Dr. Fauci made begin on page 45. Dr. Koroshetz’s talk was about NIH’s efforts to understand long COVID. Lots of trials are going on. He also mentioned this website on Covid recovery which is worth a look. 

From the unusual viruses report, Becker’s Hospital Review brings us up to date on roughly 700 cases of acute hepatitis of unknown etiology infecting young children in 34 countries, including our own. “The U.S. has reported 274 probable hepatitis cases in 39 states and jurisdictions as of June 8, according to the CDC.”

From the maternal health front, the American Hospital Association informs us

The Health Resources and Services Administration has released a report evaluating the Rural Maternity and Obstetrics Management Strategies Program, which completed its first year last August. The program uses a network approach to coordinate and improve maternal health care from preconception to postpartum; telehealth services to increase access to care in rural areas; potential aggregation of low-volume rural obstetric services; and payment structures that promote financial sustainability for access to high-quality maternal care. The cohort includes networks in Missouri, New Mexico and Texas that provided prenatal, delivery and postpartum care to 3,101 rural mothers. Participants said hiring patient navigators emerged as an early success strategy. The networks also laid the groundwork for expanding telehealth.

From the Rx coverage front, STAT News offers an interesting article about the drug pricing reform debate ongoing in Congress using an AMA Journal report showing skyrocketing launch prices for newly approved drugs.

Health Payer Intelligence tells us that “AHIP has subscribed to the Institute for Clinical and Economic Review’s (ICER) cloud-based analytics platform, providing [its] health plan members with access to benchmark reports, cost-effectiveness data, and policy recommendations.” Good idea, AHIP.

From the federal employee benefits front, a financial planner discusses how divorce may affect FEHB and FEGLI benefits at the My Federal Retirement website.

From the HIPAA standard transactions front, the CMS National Standards Group has released an updated Compliance Review Program Findings report identifying the most common violations of those standard and operating rules from compliance reviews.

Tuesday’s Tidbits

Photo by Patrick Fore on UnsplashFr

From the Omicron and siblings front, the Wall Street Journal reports

Omicron Covid-19 variants BA.4 and BA.5 are on the rise in the U.S., adding two more highly contagious versions of the virus to the mix that has fueled a springtime surge in cases.

The closely related subvariants represented a combined 13% of U.S. cases for the week ended June 4, according to estimates the Centers for Disease Control and Prevention released on Tuesday. Evidence suggests the variants are yet-more contagious versions of Omicron, public-health experts said, that may be able to evade some of the immune protections people built up from infections triggered by another version of Omicron during the winter.

The spread of the subvariants could at least prolong the time it takes to emerge from the current wave fueled by other versions of Omicron, some health experts said.

The Journal adds

This case wave hasn’t translated to a significant surge in severe illness. Hospitalizations, while up, remain far below earlier peaks, and reported Covid-19 deaths have recently hovered near historically low levels.  * * * Epidemiologists believe built-up immunity from vaccines and prior infections have bolstered defenses against severe illness, even though many people are falling ill from both breakthrough and repeat infections.

AHIP informs us

Today the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that the FDA grant emergency use authorization (EUA) for the Novavax COVID-19 vaccine in adults by a vote of 21-0.

The Committee reviewed data from Novavax showing that the benefits of the two-dose primary series outweigh the potential risks. The Committee noted the importance of making a vaccine available that has an alternative method of action, different from the mRNA vaccines currently available in the U.S., in the hope that a more traditional vaccine may appeal to those currently unvaccinated and those who may have an allergy to the components of the mRNA vaccines.

Committee members agreed that the FDA should come to an agreement with Novavax on how the company will identify and evaluate a possible causal link between its vaccine and cases of heart inflammation, though the company has argued there’s not yet enough evidence to establish a definitive link. The FDA is expected to make a decision on granting Novavax an EUA soon, whereby the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) will meet to determine when and how the vaccine should be administered.

BioPharma Dive tells us

Pfizer on Monday announced plans to invest $120 million in a drug manufacturing facility located in Kalamazoo, Michigan, which will lead to the creation of over 250 jobs.

The investment is aimed at accelerating production of Pfizer’s COVID-19 pill Paxlovid, demand for which has risen after Pfizer’s initial struggles to make sufficient quantities following the drug’s clearance in December. To date, Pfizer has delivered 12 million courses of the drug across 37 countries, 5 million of which have been shipped to the U.S.

The Kalamazoo plant, one of Pfizer’s largest drugmaking sites, will make the starting materials and active ingredient contained within Paxlovid. The new investment expands the site’s capacity, making it one of the world’s largest producers of pharmaceutical ingredients, according to Pfizer.

From the Rx coverage front, the Federal Trade Commission announced

The Federal Trade Commission announced today that it will launch an inquiry into the prescription drug middleman industry, requiring the six largest pharmacy benefit managers to provide information and records regarding their business practices. The agency’s inquiry will scrutinize the impact of vertically integrated pharmacy benefit managers on the access and affordability of prescription drugs. As part of this inquiry, the FTC will send compulsory orders to CVS Caremark; Express Scripts, Inc.; OptumRx, Inc.; Humana Inc.; Prime Therapeutics LLC; and MedImpact Healthcare Systems, Inc. * * *

The inquiry is aimed at shedding light on several practices that have drawn scrutiny in recent years including:

** fees and clawbacks charged to unaffiliated pharmacies;

** methods to steer patients towards pharmacy benefit manager-owned pharmacies;

** potentially unfair audits of independent pharmacies;

** complicated and opaque methods to determine pharmacy reimbursement;

the prevalence of prior authorizations and other administrative restrictions;

** the use of specialty drug lists and surrounding specialty drug policies;

** the impact of rebates and fees from drug manufacturers on formulary design and the costs of prescription drugs to payers and patients.

The Commisioners voted 5-0 to commence the investigation. Responses from the PBMs to the FTC’s compulsory orders are due in 90 days.

From the Pride Month front, Health Payer Intelligence reports “Members of the LGBTQ+ community reported varying experiences of discrimination in the health insurance industry but indicated that payer health equity may be improving, according to a survey from Healthcare.com.” Survey details are available in the article and the survey.

From the miscellany department

  • The American Medical Association offers expert guidance on understanding blood pressure readings.
  • The Centers for Disease Control explains the connection between diabetes and the brain.

Anthem has partnered with Happify Health to offer a slate of new digital tools for women’s health.

Happify’s platform is based on “sequences,” or digital experiences that it uses to support specific medical conditions. These sequences combine evidence-based digital therapeutics, online communities, coaching and tailored local resources in one unified platform.

Happify’s sequences are able to integrate with existing systems and solutions for ease of navigation, according to the announcement.

Everyone deserves access to mental health support that is effective and affordable. With more Americans than ever seeking help for mental health concerns, AHIP conducted a nationwide survey to understand people’s experience accessing care, whether their treatment was covered by insurance, and if insured patients were satisfied with the results. The findings reveal that nearly all respondents who sought mental health care for themselves or someone within their household over the past 2 years received treatment, and 3 in 4 insured Americans (73%) found it easy to get the care they needed. More than two-thirds of respondents were able to find an appointment with a provider in less than a month. In addition, 9 in 10 reported being satisfied with the mental health support they received, including half who say they were very satisfied.