Tuesday’s Tidbits

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From Capitol Hill Fierce Healthcare reports

Senate leadership said they reached a deal with centrist Sen. Joe Manchin, D-W.Va., to give Medicare narrow authority to negotiate lower drug prices and extend key Affordable Care Act subsides for another two years.

“We are excited about doing something on prescription drugs,” Schumer said during a press conference Tuesday. “This is something we have waited for.”

Centrist Sen. Joe Manchin, D-W.Va., had reached a narrow deal to give Medicare the power to negotiate for lower prices on up to 10 drugs in 2026 and up to 20 drugs starting in 2029. The package includes a host of other reforms that include a $2,000 cap on out-of-pocket drug costs.

The deal released earlier this month would also repeal a controversial Trump-era rule that stripped Part D rebates of their safe harbor from prosecution under federal anti-kickback laws. 

It now includes a two-year extension of a boost to ACA subsidies that has helped fuel record-breaking enrollment of more than 14 million people.

The Senate majority leader plans to move this legislation via the reconciliation process which means the Senate Parliamentarian must confirm that the bill meets the standards for the reconciliation approach.

STAT News adds that the Senate majority leadership has encountered problems from across the aisle in obtaining passage of the must-pass Food and Drug Administration users fee bill which helps fund the thousands of FDA experts who process drug review requests. Absent the necessary user fee funding, these folks will be furloughed.

From the Omicron and siblings front

AHIP tells us

Today the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) unanimously voted to recommended the use of the Novavax two-dose COVID-19 vaccine as a primary vaccine series for adults 18 years and older.  The two dose series is recommended to be administered by intramuscular injection with 3-8 weeks between doses depending on the patient risk and immunocompetency status.

The Committee reviewed data showing the vaccine is approximately 90.4% effective in preventing mild, moderate or severe COVID-19 and 79% effective in a subset of people aged 65 years or older. Additionally, the vaccine had favorable safety data that showed mild side effects. Committee members noted the hope that Novavax’s traditional protein-based vaccine will help to convince the 10-13% of adults who remain unvaccinated to receive a COVID-19 vaccine.

Members also expressed concerns about vial size, potential discard waste, and lack of an expiration date on the vial or carton, with clinicians needing to go to NovavaxCovidVaccine.com to get expiration date. The committee clearly stated that the vaccine is not recommended to be used in combination with other COVID-19 vaccines for primary or booster series completion at this time.

The FDA granted the Novavax vaccine an emergency use authorization on July 14. CDC Director Walensky is expected to make an official recommendation statement on Novavax in the coming day.

The Wall Street Journal reports that natural immunity from contracting Covid, typically has lasts 90 days. However, the highly contagious and current king of Covid infections, Omicron BA.5, can bear natural immunity based on an earlier strain of Omicron. Rest assured that your natural immunity can be expected to last 90 days when you contracted Omicron BA.5.

Also from the public health front,

The New York Times reports on the difficulties that New Yorkers infected with monkeypox have encountered when they seek treatment for that disease.

“What many of us learned in medical schools is that monkeypox is a mild, self-limiting illness,” said Dr. Mary Foote, medical director of the office of emergency preparedness and response at the city’s Department of Health, speaking at a Thursday briefing hosted by the Infectious Diseases Society of America. “But the reality on the ground is that a lot of people with this infection are really suffering.”

What’s also striking, she said, about this outbreak, is “how many of these patients have had difficulty getting the care they need to treat these symptoms.”

STAT News adds

[E]ven as global health officials race to curb spread of the virus, most experts polled by STAT said they don’t believe it will be possible to contain it.

Not everyone is categorical — or pessimistic.

Rochelle Walensky, director of the Centers for Disease Control and Prevention, and Rosamund Lewis, the World Health Organization’s technical lead on monkeypox, expressed the belief that with a lot of effort, transmission in the population of men who have sex with men can be stopped.

Walensky’s optimism in this case derives from the fact that, to date, the virus appears to be spreading mainly within a defined community — one that has mobilized to get out the word of the risk its members face.

“Within this community there was a lot of high-risk [exposures] before we were able to test enough, educate enough, both on the provider side and the patient side. And there’s a lot of that happening right now,” Walensky said.

Healio notes

In June, HHS began shipping orthopoxvirus tests to five commercial laboratory companies — Aegis Science, Labcorp, Mayo Clinic Laboratories, Quest Diagnostics and Sonic Healthcare — to increase monkeypox testing capacity and access. As of Monday, they all have begun testing, the most recent being Sonic Healthcare. * * *

In addition to increased testing, the CDC has issued travel alerts and expanded access to vaccines in response to the outbreak. HHS also ordered an additional 2.5 million doses of Bavarian Nordic’s Jynneos vaccine to strengthen preparedness. This followed an earlier order made for 2.5 million doses that will begin arriving over the next year and will bring the federal stockpile of vaccine to treat monkeypox to nearly 7 million doses by mid-2023.

Medscape reports

Overdose deaths continued increasing in 2019-2020, especially among Black and American Indian/Alaskan Native (AI/AN) individuals, the CDC reported Tuesday.

Overdose deaths in the U.S. increased by about 30% during that period, said Mbabazi Kariisa, PhD, MPH, a health scientist in the CDC’s Division of Overdose Prevention, during a phone briefing with reporters. “We know that health disparities play a key role in overdose death rates among people in certain racial and ethnic minority groups. In just 1 year, overdose death rates increased 44% for Black people and 39% for American Indian and Alaskan Native people.”

STAT News tells us “The deaths were broadly driven by illicit fentanyl, CDC officials said, though deaths attributed to other drug types, including stimulants like methamphetamine, have also been rising in recent years.”

In advocacy news, MedPage Today discusses the American Medical Association President Jack Resneck’s campaign to tie physician burnout to prior authorization and other health insurer hassles. It’s unfortunate that the various health care professional and trade associations can’t work together to reduce healthcare spending while improving quality.

In that regard, Kaiser Health News reports

Fresh off the Federal Trade Commission’s successful challenges to four hospital mergers, the Biden administration’s new majority on the commission is primed to more aggressively combat consolidation in the health care industry than it has in past years.

Although hospital mergers were supposed to improve cost efficiency, experts agree that the creation of huge conglomerates and hospital networks has driven up U.S. medical costs, which are by far the highest in the world. Many enjoy near-monopoly pricing power. * * *

Extensive research has found that prices rise when hospital systems acquire or merge with their competitors or when they buy a significant percentage of physician practices in their market. Highly consolidated markets, such as Northern California (dominated by Sutter Health) and western Pennsylvania (dominated by UPMC) tend to have higher prices.

The FTC has a long history, under both Democratic and Republican administrations, of antitrust enforcement actions to block so-called horizontal mergers between hospitals that could stifle competition in a market.

Monday Roundup

Photo by Sven Read on Unsplash

From Capitol Hill, the Hill provides a useful outline of scheduled Congressional activities for this week.

From the Omicron and siblings front,

Becker’s Hospital Review reports

BA.2.75 is the latest omicron relative catching experts’ attention, with three cases recently identified on the West Coast, Time reported July 11. 

Two cases were detected in California and one in Washington as of July 8, according to data from Helix, which works with the CDC on viral surveillance. 

The subvariant is gaining traction in India and has also been detected in 10 other countries. 

Better start looking over your shoulders Omicron subvariants BA.4 and BA.5.

The Wall Street Journal informs us

Moderna Inc. said it is developing two potential Covid-19 booster shots targeting different Omicron subvariants, citing differences in market preferences among the U.S. and other countries.

The Cambridge, Mass., company said Monday it has completed requests for regulatory authorization of one of its new booster shots in the European Union, the U.K. and Australia. The company expects to complete regulatory filings elsewhere this week.

In these countries, Moderna is seeking authorization for the use of mRNA-1273.214, a vaccine that targets both the ancestral strain of the coronavirus and the BA.1 subvariant of Omicron. The BA.1 subvariant was predominant earlier in the year but has been largely displaced by other Omicron subvariants in many countries.

In the U.S., however, Moderna will develop a different dual-target booster, mRNA-1273.222, which goes after both the ancestral strain and the BA.4 and BA.5 subvariants of Omicron. These subvariants, which are nearly identical to each other for the purposes of a vaccine, now account for most new cases of Covid-19 in the U.S.

What about BA.2.75?

An announcement from HHS today points to an FDA emergency use authorization of the traditionally developed Novovax in the near future.

The U.S. Department of Health and Human Services (HHS), in collaboration with the Department of Defense (DOD), today announced that it has secured 3.2 million doses of Novavax’s COVID-19 vaccine. The protein-based, adjuvanted vaccine will be made available for free to states, jurisdictions, federal pharmacy partners, and federally qualified health centers if it receives U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA), and recommendation from the Centers for Disease Control and Prevention (CDC). The company is expected to complete all necessary quality testing in the next few weeks, which would support final release of the product.

Medscape tells us

Treatment with oral sabizabulin (Veru Pharmaceuticals) cut the risk for death by more than 55% in hospitalized patients with COVID-19, an interim analysis of a phase 3 placebo-controlled trial found.

Sabizabulin treatment consistently and significantly reduced deaths across patient subgroups “regardless of standard of care treatment received, baseline WHO scores, age, comorbidities, vaccination status, COVID-19 variant, or geography,” study investigator Mitchell Steiner, MD, chairman, president, and CEO of Veru, said in a news release.

The company has submitted an emergency use authorization request to the US Food and Drug Administration to use sabizabulin to treat COVID-19.

The analysis was published online July 6 in NEJM Evidence.

Sabizabulin, originally developed to treat metastatic castration-resistant prostate cancer, is a novel, investigational, oral microtubule disruptor with dual antiviral and anti-inflammatory activities. Given the drug’s mechanism, researchers at Veru thought that sabizabulin could help treat lung inflammation in patients with COVID-19 as well.

Benefits Pro calls to our attention health plan stop-loss insurer Sun Life’s top 10 high-cost claim conditions report.

Sun Life’s latest report saw a 354% increase in the number of COVID-19 claims from 2020 to 2021 [the Delta variant] —specifically, 107 claims to 486 claims. Total spend also rose from $30.4M to $114.0M, although the average cost for treatment went from $283.7K to $231.2K over the same period, amounting to an 18% decrease. Even so, COVID-19 landed (“somewhat ironically,” the study stated) at number 19 on Sun Life’s top 20 list of high-cost claim conditions over four years. This is significant, as every other condition on the list has amassed four years worth of claims to COVID’s two, underlining the severity of the pandemic.

From the Rx coverage front, Fierce Pharma reports

Two manufacturers of contraceptive pills have been jockeying for FDA clearance to sell their medications over the counter for more than half a decade. Now, against the backdrop of an intense debate over reproductive rights, one of those drugmakers is officially in the running for an approval.

HRA Pharma has applied to the FDA for approval of what could be the first over-the-counter birth control pill in the U.S., the Perrigo-owned company said Monday. The move comes shortly after the Supreme Court’s decision to overturn Roe v. Wade, which has ignited a nationwide clash over reproductive rights.

HRA’s application specifically seeks to convert the prescription approval for the so-called mini pill or non-estrogen pill, dubbed Opill, into an over-the-counter approval.

At the same time, Cadence Health, another maker of birth control pills that’s been in talks with the FDA about converting its med’s approval into an over-the-counter one, said it hopes to move closer to submitting its application in the coming year, The New York Times reports.

FDA approval of OTC contraceptives should have been approved years ago, in the FEHBlog’s opinion.

From the SDOH front, Health Payer Intelligence informs us

The Association for Community Affiliated Plans (ACAP) has initiated a center designed to spur new ideas about how to address social determinants of health, according to a press release that HealthPayerIntelligence received by email.

“Longstanding racial inequities cannot improve without meaningfully addressing the social factors underlying them,” Margaret A. Murray, chief executive officer of ACAP, shared in the press release. 

“Safety Net Health Plans have worked in communities across the United States to address factors that shape their members’ health for decades. This new center creates unique opportunities to showcase what works, share that knowledge with others, and support a healthier future for people with low incomes, whose wellbeing has too often been held back by their environment.”

Bravo.

The Wall Street Journal reminds us that the new three-digit 988 suicide hotline launches on Saturday, July 16.

Health officials preparing to broaden the reach of a national mental-health crisis line are working to strengthen an overstretched network of call centers that didn’t connect with about one in six callers in recent years, a Wall Street Journal data review showed. 

The National Suicide Prevention Lifeline will transition on July 16 to a three-digit number for calls and texts, 988, from a 10-digit number that has operated since 2005 in coordination with local crisis centers. The line’s operators, including the Substance Abuse and Mental Health Services Administration and the nonprofit Vibrant Emotional Health, said they expect an increase in calls to the shorter and more memorable 988 number during the next year. Stress, suffering and disruption of routines during the pandemic has worsened many people’s mental health, clinicians have said.

Fingers crossed for this important initiative.

Weekend Update

Photo by Tomasz Filipek on Unsplash

Congress returns to Capitol Hill this week following a two-week-long break. Both the House of Representatives and the Senate will be engaged in Committee business and floor voting.

The Wall Street Journal adds

Congress returns on Monday with Democrats aiming to revive central pieces of President Biden’s stalled economic agenda while trying to keep on track a separate, bipartisan bill targeted at boosting competitiveness with China that top Republicans are threatening to block.

House Democrats also are set to roll out legislation responding to the Supreme Court ruling ending federal abortion protections. The push could include legislation to write into law the right to an abortion before fetal viability, as well as a bill intended to block any state attempts to criminalize travel for the purpose of getting an abortion. The bills wouldn’t have enough support to pass the Senate.

The three-week work period may be the last chance lawmakers have for a legislative victory before campaigning begins in earnest for midterm election races across the country. Republicans are heavily favored to win back control of the House this fall, while the Senate is seen as a tossup.

From the Omicron and siblings front, MedTecHDive Dive informs us

A single antigen test may only be able to correctly identify the virus 60% of the time in patients who have the omicron variant and who display symptoms of the disease, Tim Stenzel, director of the Food and Drug Administration’s Office of In Vitro Diagnostics and Radiological Health, said during a [recent[ meeting on testing. 

The FDA is seeing an increase in samples with the omicron variant that have a relatively low viral load, also referred to as a low positive. “Instead of seeing the usual 10% to 20% low positives in clinical studies last year, we saw a jump to 30% to 40% low positives,” Stenzel said. “When you have 40% low positives… you’re going to see a really big hit in sensitivity.”

The lower sensitivity means people testing for Covid should use multiple antigen tests to rule out a negative result, with 24 to 48 hours between tests, according to the regulator.

From the unusual viruses front, Medpage Today discusses the ties between cases of monkeypox and syphillis.

Syphilis is a known sexually transmitted infection (STI) that can manifest in lesions in the groin area and can transmit through bodily fluid. The genital sores associated with syphilis can make it easier to transmit other diseases such as HIV — and especially pressing at the current moment, genital sores or lesions are also common transmission pathways for the current B1 monkeypox outbreak. While monkeypox has not technically been categorized as an STI, there have been reports of some monkeypox patients also having STIs.

By scaling up testing and treatment for syphilis, we can better identify people who may be more likely to get and transmit monkeypox. Additionally, because the lesions in the genital region can be difficult to distinguish from those associated with syphilis, testing for both conditions is important.

The incidence of syphilis has been increasing in the U.S. In 2020 alone, there were more than 130,000 new cases of syphilis. While 43% of the new infections occur in men who have sex with men, cases have also been rising in heterosexual men and women, and over 50% of the new infections were in people ages 15 to 24. 

From the U.S. healthcare front, Fierce Healthcare tells us

Optum is still on an acquisition hot streak, scooping up Healthcare Associates of Texas, Axios reported Wednesday. * * *

HCAT has a large footprint in the Dallas-Fort Worth metropolitan area and has also invested heavily in value-based care, both of which make it an attractive buy for Optum.

Webster bought HCAT in 2016. Neither UnitedHealth nor HCAT has verified the veracity of the deal.

and

UnitedHealth Group [Optum’s parent] is aiming to address 600 million gaps in care for its members by 2025.

The healthcare and insurance giant released its annual Sustainability Report last week, where it outlined three strategic goals to improve health outcomes and affordability.

Alongside addressing care gaps, the company said it wants to ensure at least 85% of its members receive preventive care each year by 2030 as well as to make sure 55% of outpatient surgeries and radiology services are provided in high-quality, cost-efficient sites of care by 2030.

From the SDOH front, Healthcare Dive reports

The CMS’ innovation center has found evidence of implicit bias in three payment models as the agency takes an harder internal look at how its policies might perpetuate health disparities.

The use of certain risk assessment and screening tools, provider processes and payment design algorithms caused some beneficiaries to be unintentionally excluded from the Kidney Care Choices Model, Comprehensive Care for Joint Replacement Model and Million Hearts Cardiovascular Risk Reduction Model, according to a new article published in Health Affairs from Center for Medicare and Medicaid Innovation researchers.

“These findings are troubling” due to limiting access to model participation and stymied efforts to evaluate the models, researchers wrote. CMMI has taken initial steps to address existing bias, and has begun developing a guide to screen and mitigate bias in existing and future models prior to launch, according to the article.

From the nutrition front, Fortune Well offers “7 expert-backed strategies to avoid overeating when you’re working from home” and “4 expert-backed foods for a good night’s sleep.”

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.

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.

Thursday Miscellany

Photo by Josh Mills on Unsplash

From Capitol Hill, Roll Call reports

The Senate on Thursday took a major step toward broadening America’s commitment to take care of sick veterans, passing a bill to offer new health care and tax-free disability benefits to as many as 3.5 million veterans on an 84-14 vote.

Under the legislation written by Veterans’ Affairs Chairman Jon Tester, D-Mont., and ranking member Jerry Moran, R-Kan., the Department of Veterans Affairs would consider a veteran with any of 23 conditions, ranging from brain cancer to hypertension, who was deployed to a combat zone during the wars in Iraq or in Afghanistan automatically eligible for care at government cost, based on the presumption that exposure to toxic chemicals in the war zone caused the ailments.

The House must now pass the revised bill before President Joe Biden can sign it, which seems likely. The legislation largely mirrors, and slightly expands on, a House bill by Veterans’ Affairs Chairman Mark Takano, D-Calif., that passed 256-174 in March. Biden issued a statement at the time saying he supported the measure.

Under current law, veterans who believe toxic exposure during their service caused them to develop a disease can have trouble proving it, even when the linkage is known. So it’s likely that many veterans are denied care and disability benefits they deserve, advocates say. The new law, at a projected cost of $278.5 billion over 10 years, shifts the calculus, meaning the government will now pay for the care of veterans whose sickness is tied to their service, as well as others whose ailments might not be.

Because the federal government employs many veterans, this bill will reduce benefits costs for the FEHB Program once it becomes law.

From the Omicron and siblings front, the Wall Street Journal informs us

Many people are embarking on a summer of vacations, concerts and weddings put off during the height of the pandemic. Covid-19 is still finding ways to disrupt some of those plans.

Covid-19 isn’t causing acute illness and death on the scale it once did, thanks in part to protection built up by vaccines and prior infections.  * * *

The U.S. is logging some 100,000 known cases a day, and many more are being detected via at-home tests health departments don’t track. This is a stark difference from a year ago, when U.S. cases sank below 12,000 a day, the lowest level since the first surge, as vaccinations rose and many hoped the virus was in retreat.

The era of 12,000 cases a day was over when Delta and then Omicron arrived and will remain around until Omicron departs.

From the Rx coverage front —

STAT News tells us

In a notable move, the Federal Trade Commission put drugmakers and pharmacy benefit managers on notice that the agency will “ramp up enforcement” of any “illegal bribes and rebate schemes” that make it harder for patients to access lower-cost medicines.

The new policy statement noted the FTC plans to scrutinize rebates and assorted fees for signs that these payments are violating antitrust and consumer protection laws. As part of that effort, the agency expects to monitor lawsuits and file its own legal briefs in cases where it can provide assistance in analyzing illegal practices that may raise prescription drug prices.

“Today’s action should put the entire prescription drug industry on notice: when we see illegal rebate practices that foreclose competition and raise prescription drug costs for families, we won’t hesitate to bring our full authorities to bear,” said FTC Chair Lina Khan in a statement. “Protecting Americans from unlawful business practices that are raising drug prices is a top priority for the Commission.”

While the end of Omicron is not in the offing, the end of prescription drug rebates appears to be getting closer. However, the federal government should not put the kibosh on rebates unless the drug manufacturers agree to maintain the economic equities by offering price reductions equivalent to the rebates.

In other FTC news, BioPharma Dive reports

Drugmaker acquisitions of all sizes could receive closer scrutiny in the future if the Federal Trade Commission follows the advice of experts who spoke at a two-day agency meeting on market concentration and anticompetitive conduct.

The experts, mostly economists and other antitrust regulators, warned that some drugmakers have gained unfair market power due to the breadth of their product portfolios, allowing them to negotiate for preferred or even exclusive status on insurers’ coverage lists and thereby squeeze out competitors.

Taken together with the FTC’s plans to investigate the practices of pharmacy benefit managers, the meeting signals the Biden administration may take a tougher line on monopolistic practices in an effort to spark competition and target drug pricing.

From the Food and Drug Administration front, BioPharma Dive notes that

An experimental and closely followed drug for Alzheimer’s disease has failed a key clinical study, dealing yet another blow to the prevailing theory on how to treat a neurodegenerative illness that affects millions of people.

The drug’s developer, Roche, along with Banner Alzheimer’s Institute, the Phoenix-based organization helping lead the study, announced the negative results Thursday. After years following a family believed to be genetically predisposed to the disease, researchers found no significant difference in cognition or the ability to store and retrieve new memories between participants who received the drug and those who got placebo.

The failure is an upset not only to Roche, which hopes to follow its rival Biogen in getting an Alzheimer’s therapy approved for market, but also to the wider Alzheimer’s research field. For years, a protein called beta amyloid has been at the center of efforts to treat the disease. But every drug designed to block this protein, including Biogen’s, has faced setbacks. Roche’s announcement may therefore add to concerns that this protein isn’t the best research target.

In other drug research news, Walgreens announced “the launch of its clinical trial business to redefine the patient experience and increase access and retention in sponsor-led drug development research. Walgreen’s flexible clinical trial model combines the company’s vast foundation of patient insights, partner-enabled health and technology capabilities and in-person and virtual care options to break through barriers to engaging broader and more diverse communities.”

In U.S healthcare news, the American Medical Association completed its annual meeting. The AMA offers highlights from the session here.

Also, the Commonwealth Fund released its 2022 Scorecard on State Health System Performance.

Hawaii and Massachusetts top the 2022 State Scorecard rankings, based on overall performance across 56 measures of health care access and quality, service use and cost, health disparities, and health outcomes during the COVID-19 pandemic in 2020. The lowest-performing states were Mississippi, Oklahoma, and West Virginia.

The National Institutes of Health disclosed

From 2000-2019 overall life expectancy in the United States increased by 2.3 years, but the increase was not consistent among racial and ethnic groups and by geographic area. In addition, most of these gains were prior to 2010. This is according to a new study funded by the National Institutes of Health that examined trends in life expectancy at the county level. The study was led by researchers at the Institute for Health Metrics and Evaluation at the University of Washington’s School of Medicine, Seattle, in collaboration with researchers from NIH and published on June 16th in The Lancet.

MedCity News reports “Online healthcare marketplace Sesame closed a $27 million Series B funding round on Tuesday, bringing its total funding to $75 million. David Goldhill, CEO of the New York City-based startup, said the company is ‘an Expedia for medical care’ because patients can buy the care they want directly online, without the middleman of an insurance company.”

From the federal employee benefits front, Govexec delves into the impact of cost of living adjustments on federal employee retirement benefits.

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.

Midweek Update

Photo by Mel on Unsplash

From the Omicron and siblings front

The Wall Street Journal reports

The seven-day moving average of new Covid-19 cases recently topped 94,000 a day, Centers for Disease Control and Prevention data show, nearly four times lows reached in late March. The true number of new cases is likely significantly higher, epidemiologists say, because so many people are self-testing at home or not testing at all. 

The rise in cases hasn’t translated thus far into major surges in severe illness. The seven-day average of confirmed cases in hospitalized patients reached about 18,550 on Wednesday, up from lows near 10,000 in mid-April, but far below a record peak above 150,000 in January. The numbers include people who test positive on routine screening after getting hospitalized for other reasons. The daily average of reported deaths has slipped under 300 a day, the lowest point since last summer.

But * * * the more an outbreak spreads, the more likely it will reach the most vulnerable including elderly people and others with compromised immune systems, the experts say, and the more likely the virus will continue to mutate.

Bloomberg Prognosis adds

As Covid-19 again surges across the US, many people are going without time-sensitive therapeutics like Paxlovid because doctors worried about shortages are reluctant to prescribe the drugs. But the situation has changed and supplies are now abundant.

The Food and Drug Administration has issued emergency-use authorizations for the drug to treat mild to moderate Covid-19 in people who are at high risk. The Centers for Disease Control and Prevention defines those as individuals ages 50 years or older, unvaccinated, or with certain medical conditions like kidney, liver, lung and heart disease, diabetes, cancer and HIV. It also recommends the drug for people who are immunocompromised, pregnant, obese, cigarette smokers or suffering from mood disorders.

You can find the one stop test to treat locations “by using the Department of Health and Human Services’ Test to Treat Locator or by calling 1-800-232-0233.”

Kaiser Health News recommendsimproving ventilation and filtration of the air. ‘Ventilation matters a lot,’ said Dr. Amy Barczak, an assistant professor of medicine at Harvard Medical School. ‘If you’re taking care of someone at home, it’s really important to maximize all the interventions that work.’”

Viral particles float through the air like invisible secondhand smoke, diffusing as they travel. Outside the home, viruses are quickly dispersed by the wind. Inside, germs can build up, like clouds of thick cigarette smoke, increasing the risk of inhaling the virus.

The best strategy for avoiding the virus is to make your indoor environment as much like the outdoors as possible.

In related viral news, Beckers Hospital Review tells us

More than 400 children worldwide have developed unusual cases of acute hepatitis, and researchers are still searching for the cause of the outbreak, the World Health Organization said May 17.  

As of May 15, the WHO reported 429 probable cases in 22 countries, up from 348 cases a week prior, according to Philippa Easterbrook, MD, a senior scientist in the global hepatitis program at the WHO. Another 40 cases are still under investigation, and 75 percent of all affected children are under age 5. 

Twelve countries are reporting more than five cases, double the amount from last week. Of these 12 countries, nine are in Europe. In total, six children have died in the outbreak and 26 have required liver transplants, according to Dr. Easterbrook. 

As of May 17, researchers were still investigating the cause of the hepatitis outbreak. The leading hypothesis is that an adenovirus and SARS-CoV-2, the virus that causes COVID-19, may be causing hepatitis in children. Scientists are exploring “how these two infections may be working together as co-factors either by enhancing susceptibility or creating an abnormal response,” Dr. Easterbrook said. 

From the healthcare policy front, AHIP today launched

Healthier People through Healthier Markets, a new policy roadmap and set of solutions to improve health care affordability and access for every American. The effort is focused on boosting competition in health care markets and reining in harmful practices that hurt American families. With the launch of this policy roadmap, AHIP sent letters to President Biden and the leadership of Congress that lay out a detailed set of legislative and regulatory enforcement actions to increase competition in health care, drive down costs, and improve health care access for patients.

The FEHBlog supports this approach.

From the mental healthcare front, Govexec reports

The Office of Personnel Management on Wednesday urged federal agencies to ensure their employees are aware and can access the mental health benefits provided to federal workers, in light of May being Mental Health Awareness Month.

In a memo to agency heads, OPM Director Kiran Ahuja noted that promoting the federal workforce’s wellbeing, including mental health, is a priority in President Biden’s management agenda.

“We want to make sure that all federal employees understand the supports available to them and underscore that there should be no shame or stigma for taking care of their mental health,” Ahuja wrote. “[As] a reminder, employee assistance programs and Federal Employees Health Benefits health plans offer mental health services to employees and their family members. We encourage agencies to proactively communicate to their workforces about their options and encourage employees to contact their agency benefits officers or EAP coordinator to learn more.”

The FEHBlog encourages OPM to better coordinate mental health care services among FEHB plans, EAPs and wellness programs.

From the telehealth front

  • mHealth Intelligence informs us “In the second half of 2020, only 14.1 percent of children used telehealth due to the pandemic, but use was higher among those with asthma, a developmental condition, or a disability, the Centers for Disease Control and Prevention (CDC) found.”

From the survey department, Beckers Payer Issues advises that “Castlight Health analyzed more than 160 million commercial medical claims nationwide to reveal insights about healthcare utilization patterns from 2018 to 2021.” Castlights report ranks the fifty States and DC based on average medical spending per member in 2021.  

From the miscellany department —

  • Beckers Payer Issues reports “Anthem shareholders voted at their annual meeting May 18 to change the company’s name to Elevance Health.”
  • Federal News Network discusses the Postmaster General’s plans to close and consolidate Postal facilities across the delivery network. “The network transformation initiative will impact nearly 500 network mail processing locations, 1,000 transfer hubs and 100,000 carrier routes. It will also impact 10,000 delivery units, which USPS defines as post offices, stations, branches or carrier annexes that handle mail delivery functions.”
  • FedSmith tells us “Starting May 26, 2022, federal retirees will notice a new process for signing into the OPM Retirement Services Online website. The login process will now be managed through the federal government’s Login.gov website and will require you to create a new username and password at login.gov if you do not currently have one.”

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From the Omicron and siblings front —

The Secretary of Health and Human Services has extended the Covid public health emergency for another 90 days. Bloomberg explains, “The declaration allows the US to grant emergency authorizations of drugs, vaccines and other medical countermeasures, as well as administer those products to millions of people at no out-of-pocket cost. It’s also enabled millions of Americans to get health coverage through Medicaid, among other benefits.” Bloomberg’s sources expect the declaration to be renewed again in July 2022.

The American Hospital Association informs us

The Food and Drug Administration today authorized a single Pfizer COVID-19 booster dose for children aged 5-11 who completed the Pfizer vaccine primary series at least five months before. FDA authorized the vaccine for this age group last October.

“The FDA has determined that the known and potential benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age at least five months after completing a primary series outweigh its known and potential risks and that a booster dose can help provide continued protection against COVID-19 in this and older age groups,” said Peter Marks, M.D., director of FDA’s Center for Biologics Evaluation and Research.

In public health news —

  • The federal government’s Million Hearts campaign has launched a website discussing hypertensive disorders of pregnancy. The site explains “Hypertensive disorders of pregnancy are a leading cause of maternal mortality and can put both mother and baby at risk for problems during pregnancy.1 High blood pressure can also cause problems during and after delivery. Importantly, hypertensive disorders of pregnancy are often preventable and treatable.”
  • The Centers for Disease Control has updated its website discussing diabetes and heart disease. The FEHBlog knows from his PCP about the dangerous relationship between those two diseases.

In survey news —

  • Beckers Hospital Review relates that “The Lown Institute, a nonpartisan healthcare think tank, released its ranking May 17 of the best hospitals in the U.S. for avoiding overuse of low-value tests and procedures.”
  • Fierce Healthcare tells us, “Utah is the healthiest state for seniors this year, earning high marks for low prevalence of smoking and excessive drinking, according to a new report from the United Health Foundation. The philanthropic arm of UnitedHealth Group issued its annual America’s Health Rankings senior report Tuesday morning, which highlights state-specific performance across a slew of measures as well as progress, or lack thereof, on several key health issues facing seniors.”

From the healthcare business front

Fierce Healthcare reports

Private insurance plans paid hospitals on average 224% more compared with Medicare rates for both inpatient and outpatient services in 2020, a new study found. 

Researchers at RAND Corporation looked at data from 4,000 hospitals in 49 states from 2018 to 2020. While the 224% increase in rates is high, it is a slight reduction from the 247% reported in 2018 in the last study RAND performed. 

“This reduction is a result of a substantial increase in the volume of claims in the analysis from states with prices below the previous average price,” the study said. 

The report showed that plans in certain states wound up paying hospitals more than others. It found that Florida, West Virginia and South Carolina had prices that were at or even higher than 310% of Medicare. 

But other states like Hawaii, Arkansas and Washington paid less than 175% of Medicare rates. 

The American Hospital Association replies

The RAND Corporation’s latest hospital pricing report again “overreaches and jumps to unfounded conclusions based on incomplete data,” AHA President and CEO Rick Pollacksaid today. “The report looks at claims for just 2.2% of overall hospital spending, which, no matter how you slice it, represents a small share of what actually happens in hospitals and health systems in the real world. RAND also continues to ignore that hospitals are not all the same. Researchers should expect variation in the cost of delivering services across the wide range of U.S. hospitals — from rural critical access hospitals to large academic medical centers. Tellingly, when RAND added more claims as compared to previous versions of this report, the average price for hospital services declined. This suggests what we have long suspected: you simply cannot draw credible conclusions from such a limited and biased set of claims. 

“Further, the results highlight what even the Medicare Payment Advisory Commission (MedPAC) acknowledges: Medicare does not fully cover the cost of providing care to Medicare beneficiaries. Pinning commercial prices to inadequate Medicare rates would cause even more financial strain to hospitals already facing tremendous challenges as a result of the ongoing COVID-19 pandemic and rising inflation. The result could be reduced patient access to care.” 

I agree with the American Hospital Association that the problem is Medicare. Why Sen. Sanders continues to push Medicare for All is a mystery to the FEHBlog.

Also, Healthcare Dive informs us

Humana plans to open about 100 new value-based primary care clinics for Medicare patients between 2023 and 2025 through its second joint venture with private-equity firm Welsh, Carson, Anderson & Stowe, according to a Monday release from the payer.

The clinics will be managed and operated under Humana’s CenterWell Senior Primary Care brand, and WCAS will have majority ownership while Humana will have a minority stake.

The $1.2 billion expansion builds upon an existing venture with the same firm to open 67 clinics by early 2023.

From the Rx coverage front, Drug Channel reports on “The State of Specialty Pharmacy 2022: Reflections, Trends, and Photos from #Asembia22.”

I had the honor of presenting during the event’s general session: The Specialty Pharmacy Industry Update & Outlook. As in past years, I was joined by Doug Long from IQVIA. 

You can download our full slide deck here: https://drugch.nl/asembia22

From the mental healthcare front, Health Payer Intelligence discusses another angle considered in the UHG report on seniors mentioned above.

Over the last decade, seniors have experienced rising rates of mental healthcare needs, drug-related deaths, and early mortality, the UnitedHealth Foundation’s 2022 Senior Report shows.

“The 2022 Senior Report shows that the wellbeing of older adults was declining before the pandemic, which we know exacerbated many of these challenges,” Rhonda Randall, DO, executive vice president and chief medical officer of UnitedHealthcare Employer and Individual, said in the press release

“We urge people to help the seniors in your lives reconnect with the communities and activities they have enjoyed in the past but may not yet have returned to. We are focused on reducing disparities in the health care system for everyone, including older Americans.”

In webinar news — The Labor Department is holding a virtual event on May 25 concerning building mental health-friendly workplaces.

Monday Roundup

From the Omicron and siblings front —

  • Bloomberg observes “Covid hospitalitalization count makes vaccines seem less effective, Researchers say. The researchers point out that a patient who tests positive for Covid is a Covid hospitalization even if the patient is hospitalized for an unrelated reason.
  • In its recent review of Covid pills, the Institute for Clinical Review (ICER) gave a mildly favorable report on using an inexpensive anti-depressant fluvoxamine to treat Covid. This part of the ICER report was physician investigator-initiated. Those investigators sought FDA approval. Today, however, STAT News reports that “In an unusual two-page summary — the FDA does not generally disclose the reasoning behind rejections — regulators said that the doctors failed to provide adequate evidence of the effectiveness of the drug, called fluvoxamine.” The investigators indicated that more fluvoxamine trials are ongoing as well as trials of other repurposed drugs.
  • The National Institutes of Health announced today that a research team is successfully using deidentified electronic health record data to better identify characteristics of persons with long Covid. “One reason long COVID is difficult to identify is that many of its symptoms are similar to those of other diseases and conditions. A better characterization of long COVID could lead to improved diagnoses and new therapeutic approaches.”
  • Roll Call delves into the use of wastewater surveillance to track Covid trends. Urban areas are good — rural areas are not so good.
  • Medpage Today offers an epidemiologist’s perspective on the occasionally observed Omicron rebound from Paxlovid, the Pfizer Covid pill. Reuters adds, “Pfizer has said that from more than 300,000 patients it is monitoring who received the 5-day treatment, around 1-in-3,000 – about 0.03% – reported a relapse after taking the pills.”

In other FDA news, MarketWatch informs us

The Food and Drug Administration on Monday authorized a test developed by Laboratory Corporation of America Holdings LH, -0.92% that allows people in the U.S. to self-test for respiratory syncytial virus (RSV), a type of common cold, as well as the flu and COVID-19. The test does not require a prescription. People swab at home and send the test by mail to a Labcorp lab. Results are then made available in an online portal. Teens and children are also authorized to test with the support of adults. The test kit costs $169 and may be covered by insurance, according to a spokesperson. It is expected to be available within the next three weeks. 

That’s helpful.

From the SDOH front —

  • Health Day informs us that “a new study shows that telemedicine has closed the gap in access to primary care between Black and non-Black Americans.”
  • Beckers Payers Issues tells us “Despite little change before the pandemic, the number of adults with medical debt, issues paying medical bills and medical debt in collections have declined since the pandemic began. New policies will be needed to sustain the decrease, according to a May 11 report from the Urban Institute.” 

From the preventive care front, Healio reports

A decrease in cervical cancer rates in the United States, most notably among younger women, may be associated with HPV vaccination approval, according to a retrospective, cross-sectional study published in JAMA Network Open

Researchers added that an increase in oropharyngeal and anal/rectal cancers, particularly among men, highlights a need for vaccination uptake among both men and women.

From the interoperability front, the Sequoia Project “selected by the Office of the National Coordinator for Health IT (ONC) as the Recognized Coordinating Entity (RCE) to support the implementation of the Trusted Exchange Framework and Common Agreement (TEFCA), today released additional details regarding the process and requirements for becoming a Qualified Health Information Network (QHIN). The Sequoia Project is requesting feedback on these items before the final documents are released.” The Sequoia Project’s comment deadline is June 15, 2022, and “drafts are available on the RCE website.”

From the healthcare business front, Healthcare Dive reports

Hospitals’ labor costs rose by more than a third from pre-pandemic levels by March 2022, according to a report out Wednesday from Kaufman Hall.

Heightened temporary and traveling labor costs were a main contributor, with contract labor accounting for 11% of hospitals’ total labor expenses in 2022 compared to 2% in 2019, the report found.

Contract nurses’ median hourly wages rose 106% over the period, from $64 an hour to $132 an hour, while employed nurse wages increased 11%, from $35 an hour to $39 an hour, the report found.

In other government news —

  • The Department of Health and Human Service is marking the 10th anniversary of the National Plan to Address Alzheimer’s Disease. “HHS is commemorating the Anniversary through a series of publications and presentations highlighting the Department’s accomplishments in addressing Alzheimer’s disease and related dementias (ADRD), including those at the Centers for Disease Control and Prevention (CDC), Administration for Community Living (ACL), National Institutes of Health (NIH), Indian Health Service (IHS), and other HHS agencies. HHS will also sponsor a state policy roundtable to hear from state leaders about their work to address ADRD.  All events and materials will be shared on the 10th Anniversary HHS page.”
  • The Society for Human Resource Management relates that “An FAQ explains that the EEOC will permit employers to submit their EEO-1 Reports after the May 17 deadline, during what the agency is calling the “failure to file” phase. The EEOC stated, “All filers who have not submitted and certified their mandatory 2021 EEO-1 Component Report(s) by the Tuesday, May 17, 2022, published deadline will receive a notice of failure to file instructing them to submit and certify their data as soon as possible, and no later than Tuesday, June 21, 2022.”  All FEHB carriers must file this report.