Thursday Miscellany

U.S. Healthcare

Thursday Miscellany

David Ermer–Congress, COVID treatment, COVID-19, COVID-19 vaccine, Employee Wellness Programs, Federal employment benefits, Mental health care, OPM, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Capitol Hill

Roll Call tells us

Senators negotiating a COVID-19 supplemental funding package have an “agreement in principle” to provide roughly $10 billion for the Department of Health and Human Services to stock up on waning domestic supplies for combating the virus, according to Sen. Roy Blunt, R-Mo.

Blunt, the top Republican on the Senate Labor-HHS-Education Appropriations Subcommittee, said both parties have tentatively agreed to offsets for the $10 billion that would repurpose unspent funds from prior pandemic relief laws.

The offsets negotiators agreed to include $2.2 billion from unused grant funds for venues like zoos and theaters and $2 billion in untapped assistance to the aviation and manufacturing industry, Blunt said. His comments to reporters came after a Republican Conference lunch in which lead GOP negotiator Sen. Mitt Romney of Utah briefed his colleagues on the agreement in principle. 

Fierce Healthcare informs us

The House [of Representatives] passed a bill on Thursday that caps the out-of-pocket cost of insulin at $35 a month for beneficiaries in Medicare Part D and for certain group and individual plans.

The Affordable Insulin Now Act, which passed the House via a 232 to 193 vote, comes as work in the Senate continues on a bipartisan alternative that could bring additional changes. * * *

Private plans would also be required to offer first-dollar coverage of insulin without any deductible, according to an analysis from the Congressional Budget Office. 

The cap on cost-sharing for private insurance plans would implement in 2023.

The Hill offers a related article explaining why insulin prices are so “troubling” high.

HR Dive reports

Among the provisions of this month’s $1.5 trillion omnibus spending bill, Congress included a revival of an exemption that allowed high-deductible health plans to cover telehealth before individuals meet their deductible.

The provision was originally created by the Coronavirus Aid, Relief, and Economic Security Act, which sunset at the end of 2021. The provision will resume April 1 but will again sunset at the end of this year.

From the Omicron and siblings front, the Wall Street Journal discusses the state of Covid treatments and offers its advice on who should seek out a second Covid booster besides the immunocompromised.

From the OPM front, Govexec projects OPM’s actions over the next 18 months based on the FY 2022 to FY 2026 strategic plan released last Monday. In short, “Hire, Hire, Hire.”

Govexec also discusses efforts underway by OPM, the Social Security Administration and the Thrift Savings Plan to improve the customer service experience of federal employees and retirees. Good luck with that.

From the research front the National Institutes of Health announced

Scientists have published the first complete, gapless sequence of a human genome, two decades after the Human Genome Project produced the first draft human genome sequence. According to researchers, having a complete, gap-free sequence of the roughly 3 billion bases (or “letters”) in our DNA is critical for understanding the full spectrum of human genomic variation and for understanding the genetic contributions to certain diseases. The work was done by the Telomere to Telomere (T2T) consortium, which included leadership from researchers at the National Human Genome Research Institute (NHGRI), part of the National Institutes of Health; University of California, Santa Cruz; and University of Washington, Seattle. NHGRI was the primary funder of the study.

Analyses of the complete genome sequence will significantly add to our knowledge of chromosomes, including more accurate maps for five chromosome arms, which opens new lines of research. This helps answer basic biology questions about how chromosomes properly segregate and divide. The T2T consortium used the now-complete genome sequence as a reference to discover more than 2 million additional variants in the human genome. These studies provide more accurate information about the genomic variants within 622 medically relevant genes. * * *

The now-complete human genome sequence will be particularly valuable for studies that aim to establish comprehensive views of human genomic variation, or how people’s DNA differs. Such insights are vital for understanding the genetic contributions to certain diseases and for using genome sequence as a routine part of clinical care in the future. Many research groups have already started using a pre-release version of the complete human genome sequence for their research.  

From the mental healthcare front, the American Hospital Association calls our attention to a new GAO report.

Consumers with health coverage experience challenges finding in-network mental health providers, who may not be accepting new patients or have long wait times to see them, according to a new report from the Government Accountability Office. Factors contributing to these challenges include low reimbursement rates for mental health services and inaccurate or out-of-date information on provider networks, GAO said. The report also looks at ongoing and planned federal efforts to address these challenges, for example by increasing the mental health workforce, mental health system capacity and oversight of health plan compliance with mental health parity laws.

This squib caused the FEHBlog to recall a comment that he heard at a conference — Four out of five doctors are in-network but only one out of five mental health providers are in-network with the notable exception of hub and spoke telemental services.

Yesterday the FEHBlog suggested that in return for three free primary care visits and three behavioral health visits, plan members should name and use their in-network primary care provider and primary mental health provider. The FEHBlog is sticking with this idea for the in-network primary care provider but he recognizes the idea may be premature for the in-network primary mental health provider. Of course, creating a looser standard for free mental health care compared to primary care is compliant with the federal health parity rule. The reverse would violate the often fuzzy non-quantitative treatment limitations created by the law.

From the miscellany department —

  • STAT News tells us “With Medicare expected to cover a projected 80 million people by 2030,He entrepreneurs and investors are cashing in on what analysts see as an inevitable shift in health care away from the hospital and into the homes of aging patients.” The publication identifies five related technology trends.
  • Fierce Healthcare reports “Virtual care startup Hims & Hers is teaming up with Carbon Health to offer patients in California with direct access to providers for in-person medical appointments at clinics. The collaboration will provide easy and comprehensive access to a broader range of care options through the Hims & Hers platform, company executives said.”
  • Health Payer Intelligence informs us “Large employers are investing more in their wellness program design in 2022 and their programs revolve around hybrid work environments, job satisfaction, and equity, the Business Group on Health found in a survey.”

Midweek update

David Ermer–COVID-19, Federal employment benefits, OPM, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From the OPM front —

Here is a link to OPM’s 2023 Congressional Budget Justification for Fiscal Year 2023, which confirms on page 36

Beginning in plan year 2023, this proposal would require all plans and issuers, including FEHB carriers, to cover three primary care visits and three behavioral health visits each year without charging a copayment, coinsurance, or deductible-related fee. For High Deductible Health Plans, these services would be considered pre-deductible for meeting Health Savings Account requirements. This proposal would increase FEHB premiums by approximately 0.8 percent.

In the FEHBlog’s opinion, OPM should condition these “free” visits on requiring the plan member to identify and use an in-network primary care provider or in-network primary behavioral care provider. Members who develop relationships with their healthcare providers in this manner are more likely to undergo preventive care and otherwise follow medical advice. That’s common sense. It’s worth adding that the Affordable Care Act typically limits reduced cost-sharing to claims involving in-network care.

Meanwhile, Meritalk discusses OPM’s perspective on the President’s proposed budget, and Federal News Network explains why diversity goals are crucial to the success of OPM’s FY 2022 to FY 2026 strategic plan.

FedSmith.com discusses the impact of retirement on federal employee benefits.

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

President Biden on Wednesday said the nation was in a new phase of the Covid-19 pandemic as he marked the launch of a new federal website where Americans can identify virus risks in their areas and recommendations for mitigating the threat.

The website, COVID.gov, aims to be a one-stop shop to help people get information on measures that could help protect them from the virus, such as local guidance for mask wearing and where to find free masks, vaccines and clinics that offer tests and oral antiviral treatments, Mr. Biden said.

“We’re now in a new moment in this pandemic,” Mr. Biden said. “It does not mean that Covid-19 is over. It means that Covid-19 no longer controls our lives.”

The FEHBlog is pleased to see that the new site includes a link that allows you to find a test to treat program near you.

From the Rx coverage front, BioPharma Dive informs us

By a slim margin, advisers to the Food and Drug Administration have concluded that the agency should hold off approving a closely watched, experimental medicine for ALS until researchers generate more evidence that it works.

Composed of neuroscience and drug development experts, the 10-person advisory committee on Wednesday voted 6 to 4 against the medicine, named AMX0035 and developed by the Cambridge, Massachusetts-based biotechnology company Amylyx Pharmaceuticals. In a study of about 140 volunteers, AMX0035 appeared to show modest benefits on survival and day-to-day function for patients with rapidly progressing ALS, better known to some as amyotrophic lateral sclerosis or Lou Gehrig’s disease. * * *

The FDA isn’t required to follow its advisers’ recommendations. But it usually does, making approval of AMX0035 now more of a long shot. A final decision is expected by late June.

In other news —

RAC Monitor notes that the Consolidated Appropriations Act 2022 continues to prohibit federal funding for the national patient identifier otherwise required by HIPAA. That’s unfortunate for the country.

Healthcare Economist discusses its views on high deductible plans that are a prerequisite to funding health savings accounts.

Tuesday’s Tidbits

David Ermer–CDC, COVID-19, COVID-19 vaccine, Federal employment benefits, Mental health care, OPM, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill, Congress.gov informs us that Congress has sent the Postal Reform Act of 2022 (HR 3076) to the President for his signature.

MedPage Today discusses a Congressional hearing on Medicare for All held today. Democrats (for) and Republicans (against) remain split.

The FEHBlog finds the President’s budget proposal useful for identifying new Administration FEHB priorities, several of which were identified in yesterday’s post. What’s more, FedWeek tells us

[T]he FEHB program would be among programs affected by a broader proposal regarding mental health service coverage in health insurance. It would require coverage of three primary visits and three behavior health visits without cost-sharing.

In the FEHBlog’s opinion, this idea would drive up premiums for no reason because federal and postal employees already are offered employee assistance programs that offer free counseling sessions. OPM needs to do a better job coordinating its various benefit programs.

Fierce Healthcare identifies four other healthcare items from the President’s budget proposal that should be watched.

From the Omicron (and siblings) front —

The Wall Street Journal reports

The Omicron BA.2 variant represents more than half of new Covid-19 cases in the U.S., the latest federal estimates show, as signs suggest infections are edging higher again in parts of the Northeast.

The region has the highest BA.2 concentrations, including more than 70% in an area including New York and New Jersey, according to estimates the Centers for Disease Control and Prevention released Tuesday. BA.2 has been moving steadily higher for more than a month and represents an estimated 55% of national cases in the week ended March 26, the CDC said. * * *

“Predictions are hard, but I am expecting that the U.S. will have a surge in at least some locations,” said Aubree Gordon, an associate professor of epidemiology at the University of Michigan School of Public Health.

AHIP tells us

Today the Food and Drug Administration (FDA) authorized a second single Pfizer-BioNTech or Moderna COVID-19 vaccine booster dose for persons aged 50 and older at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine. A second booster dose of the Pfizer-BioNTech COVID-19 vaccine or Moderna COVID-19 vaccine may also be administered to certain immunocompromised individuals, for those 12 years of age and older or 18 years of age and older, respectively, at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine.

The FDA previously authorized a single booster dose for certain immunocompromised individuals following completion of a three-dose primary vaccination series. This action will now make a second booster dose of these vaccines available, for a total of five vaccine doses authorized for populations at higher risk for severe disease, hospitalization and death. Emerging evidence suggests that a second booster dose of an mRNA COVID-19 vaccine improves protection against severe COVID-19 and is not associated with new safety concerns. * * *

This authorization still requires the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) to formally recommend the vaccine for the specific populations.  No date for an ACIP meeting has yet been announced.

Health plans are not required to reimburse these authorized vaccines until ACIP makes its decision.

From the healthcare business front —

Healthcare Dive reports

Hospitals’ operating margins were negative in February for the second consecutive month even as cases of the omicron variant waned, according to Kaufman Hall’s National Hospital Flash report. Negative margins in January were the first seen in 11 months.

The median Kaufman Hall Operating Margin Index was -3.45%, up from -4.25% in January but still well below levels hospitals can sustain, the report said.

Volumes for inpatient services fell while outpatient volumes staggered with revenues in those categories falling 19.3% and 5%, respectively, from January, according to the report.

Healthcare Finance News reports

UnitedHealth Group subsidiary Optum will combine with in-home healthcare service provider LHC Group, with UHG purchasing the latter for about $5.4 billion.

LHC provides healthcare services in the home for a demographic of mostly older patients dealing with chronic illnesses and injuries. It will be melded with Optum, which manages drug benefits and offers data analytics services and works with more than 100 health plans.

From the tidbits department —

  • The CDC has posted a new, improved anti-biotic resistance website. The CDC explains that the site is “refreshed to better engage and share information on antibiotic resistance (AR) in the United States and around the world. We all have a role to play—from travelers, animal owners, and care givers to patients and healthcare providers—to fight this deadly threat and now you can quickly access CDC’s latest resources.”
  • MedPage Today reports “Prediabetes prevalence nearly doubled among U.S. youth from 1999 to 2018, national data indicated. According to National Health and Nutrition Examination Survey (NHANES) data on over 6,500 youth, the prevalence of prediabetes increased from 11.6% in 1999-2002 to 28.2% in 2015-2018, Junxiu Liu, PhD, of Icahn School of Medicine at Mount Sinai in New York City, and colleagues reported in JAMA Pediatrics.” Obesity is a common thread.
  • The Endocrinology Network informs us “Participation in a tele-mentoring program led by Robert Wood Johnson Medical School was associated with a 44% decrease in inpatient admissions and a more than 60% decrease in inpatient spending among Medicaid patients with diabetes.” Bravo.
  • The International Foundation of Employee Benefit Plans discusses evaluating high cost gene therapy financing programs.

Weekend Update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Thought Catalog on Unsplash

The House of Representatives and the Senate will be in session for Committee business and floor voting on Capitol Hill this week.

The President will send his fiscal year 2023 federal budget to Capitol Hill tomorrow. The Wall Street Journal offers an explanatory article about this process.

From the federal employment front, Federal News Network discusses the progress of recalling federal employees to their offices.

Also, the FEHBlog noticed that the Federal Times offers a 2022 Federal Benefits Guide — “Answers to commonly asked questions from federal employees, helpful resources, and more.”

From the vaccines front —

  • Precision Vaccines informs us “After decades of false starts, new research indicates four Respiratory Syncytial Virus (RSV) vaccine candidates are nearing the completion of late-stage trials. According to the U.S. CDC, RSV vaccines could drastically reduce hospital and intensive-care admissions for young children and seniors.” Fingers crossed.

[T]here is now a growing body of research that’s offering at least some reassurance for those who do end up getting infected — being fully vaccinated seems to substantially cut the risk of later developing the persistent symptoms that characterize long COVID.

While many of the findings are still preliminary, the handful of studies that have emerged in the past half year are telling a relatively consistent story.

“It may not eradicate the symptoms of long COVID, but the protective effect seems to be very strong,” says epidemiology professor Michael Edelstein, of Bar-Ilan University in Israel, who’s studying long COVID.

From the mental healthcare front —

  • The Wall Street Journal reports “Telemedicine startups make it easier to get ADHD Drugs. That made some [startup] workers anxious. Digital companies such as Cerebral and Done seized on looser pandemic rules for prescribing ADHD drugs like Adderall. Some workers said they felt pressure to provide the medications.”
  • Health Payer Intelligence points out

Employee mental healthcare spending rose, and employer mental healthcare spending fell after employers transitioned their workers from preferred provider organizations to high deductible health plans, a study from the Employee Benefit Research Institute (EBRI) found.

The researchers focused on individuals who had been diagnosed with one of three specific mental health conditions to assess the impact of transitioning from a preferred provider organization to a high-deductible health plan: anxiety, attention deficit hyperactive disorder (ADHD), and major depressive disorder (depression).

The study received funding from a handful of organizations, including the Blue Cross Blue Shield Association, the Independent Colleges and Universities Benefits Association (ICUBA), Pfizer, and PhRMA.

[T]he researchers indicated that high deductible health plans could be improved if employers apply value-based care to their high deductible health plan benefit design.

“Smarter deductibles accommodating services preventing the exacerbation of chronic conditions might be a natural evolution of health plans,” the study concluded. “Interventions that improve patient-centered outcomes while maintaining affordability may be found in the form of a clinically nuanced health plan that better meets workers’ clinical and financial needs.”

Because it remains National Kidney Month, the FEHBlog wishes to draw attention to this Fierce Healthcare article about how CVS Health offers personalized kidney care for health plan members.

CVS Kidney Care aims to provide an end-to-end experience to manage kidney care in the long term before it reaches chronic kidney disease or end-stage renal disease. It takes a home-first approach to its care model and is currently co-developing a hemodialysis device that is built specifically with home care in mind.

The device is co-developed by Deka Research & Development and is currently in clinical trials. [CVS Kidney Care President Lisa] Rometty said CVS expects to complete the trial by the end of this year, with anticipated approval and launch sometime in 2023.

CVS chose to get involved in developing the tool, she said, because the company saw an unmet need in the market for a device that’s built from the ground up for in-home dialysis rather than adapted to it. Existing tools are not designed to be easy for a senior patient to understand, for example, Rometty said.

“We did it because we really felt strongly at the time that there wasn’t at the time a device that would meet the unique experience and ease of use and also the safety and clinical aspects,” Rometty said.

Friday Stats and More

David Ermer–COVID-19, COVID-19 vaccine, Mental health care, No Surprises Act, Telehealth, U.S. Healthcare–

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 12th week of 2022:

In the current CDC Covid Data Weekly Tracker, the CDC explains

In February, CDC’s COVID Data Tracker released a Wastewater Surveillance tab, which tracks changes and detections of SARS-CoV-2 viral RNA levels at more than 600 testing sites across the country. Because many people with COVID-19 shed the virus in their feces, wastewater testing can help us monitor COVID-19 in communities. Virus levels in wastewater usually increase four to six days before clinical cases increase, so surveillance results can help communities act quickly to prevent the spread of COVID-19.

Currently, virus levels in wastewater are relatively low across the country. More than half of all sites reporting wastewater data are experiencing a decrease in SARS-CoV-2 levels, but some have reported a modest uptick. These upticks may reflect minor increases from very low levels to levels that are still low. It’s important to note that even a small increase when levels are very low can appear like a dramatic increase in the percent change. However, there is a possibility that some communities might start to see an increase in COVID-19 cases. This could happen for a variety of reasons, like waning immunity, new circulating strains, and eased prevention strategies.

Right now, it’s too early to know if we’ll see a corresponding increase in reported cases across the country. Wastewater data are meant to be used with other COVID-19 surveillance data. CDC encourages local public health officials to watch for sustained increasing levels of the virus in wastewater, and to use wastewater surveillance data with other kinds of data to inform their decisions. CDC continues to encourage people to use COVID-19 Community Levels to find out what actions they should take to protect themselves and others. The whole community can be safe only when we all take steps to protect each other.

Using the same approach, here is the FEHBlog’s latest weekly chart of Covid deaths:

Precision Vaccinations adds that

[T]he 2022 trend data from the CDC indicates pneumonia may soon overtake COVID-19 as the leading cause of respiratory death in the U.S.

Historically, the CDC reported the number of visits to emergency departments with pneumonia as the primary diagnosis averaged about 1.5 million, which led to 47,000 deaths annually.

The good news is pneumonia is a vaccine-preventable disease.

Unfortunately, the percentage of adults who had ever received a pneumococcal vaccination was 25.5% in 2020.

Increasing the pneumococcal vaccination rate is a worthy goal for health plans and primary care providers.

Here’s is the FEHBlog’s weekly chart of Covid vaccinations distributed and administered in the Covid vaccination era:

While recent vaccinations numbers are nothing to crow about, over 75% of Americans age 18 and older are fully vaccinated. Nearly half of the same population and over two-thirds of Americans age 65 and older have received a booster.

Politico adds

The Biden administration could authorize a second Covid-19 booster shot for older Americans within weeks, amid rising concern over a potential resurgence of cases, four people with knowledge of the matter told POLITICO.

The move under consideration by senior health officials would recommend the additional vaccine dose for adults 65 and older, in an effort to better protect high-risk people and stave off a wave of hospitalizations should infections climb rapidly as a result of the spread of the Omicron subvariant, BA.2. Currently, second boosters are only recommended for those with compromised immune systems.

From the No Surprises Act front, last Monday, Federal District Judge Richard Leon heard oral argument on dispositive cross-motions submitted by medical associations and the federal government regulators concerning the status of the qualifying payment amount in the baseball arbitration process. The FEHBlog has heard from a couple of sources who attended the hearing that Judge Leon indicated that he does not plan to put deciding the case on his front burner because the federal regulators advised him about their intent to issue the final, final rule on the Independent Dispute Review process in May 2022. The case is pending in the U.S. District Court for the District of Columbia.

From the telehealth front, mHealth Intelligence informs us

More than two-thirds of telehealth providers said they use audio-only modalities to offer telehealth services, according to a recent survey conducted by the American Medical Association.

The survey polled 2,232 physicians between Nov. 1 and Dec. 31, 2021.

The popularity of telehealth among physicians is apparent, with 85 percent saying they still use it. But 52 percent agreed that their telehealth usage has decreased since they first started offering the services. The top reason for the decrease was that they moved to a hybrid model of care with both in-person and virtual care services.

From the healthcare business front —

Fierce Healthcare reports

Optum has quietly acquired Refresh Mental Health from private equity firm Kelso & Company, Axios reported Thursday.

The company confirmed the deal in a statement to the outlet. The acquisition has not been announced publicly as of yet.

“Optum and Refresh Mental Health are excited to expand effective behavioral care to patients through a more coordinated health system,” the company said in a statement to Axios. * * *

Refresh was founded in 2017 and provides outpatient mental and behavioral health services. It runs 300 locations across 37 states that offer a variety of services including psychiatry and substance abuse treatment.

and

Bicycle Health, a virtual provider for opioid use disorder, is partnering with five additional payers, it said in an announcement provided exclusively to Fierce Healthcare.

The partnerships are with Molina Healthcare and McLaren Health Plans in Michigan, UHC Community Plan in Arizona, Health First Colorado (the state’s Medicaid program) and Blue Cross Blue Shield Texas. In total, these payer partnerships have the potential to reach more than 8 million patients, the company said. Coverage will include medication management, behavioral health (individual or group psychotherapy, medical care), support groups and care coordination.

“From high costs to significant time commitments, many traditional OUD recovery programs just aren’t realistic options for the vast majority of patient experiences,” Bicycle Health CEO and founder Ankit Gupta said in a statement. “We are committed to making science-based, holistic OUD treatment accessible to all who need it—and these partnerships are an exciting step towards that goal.”

Thursday Miscellany

David Ermer–COVID-19, COVID-19 vaccine, Federal employment benefits, U.S. Healthcare–
Photo by Josh Mills on Unsplash

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

The recent rise in Covid-19 cases in the U.K. has U.S. health experts watching closely, as the Delta and Omicron variant trends in Europe have tended to presage those in the U.S. * * *

While hospitalizations have risen in the U.K. recently, the number of patients requiring ventilators hasn’t increased at the same pace, according to U.K. health data.

Counts of newly admitted Covid-19 patients in U.S. hospitals are at their lowest recorded level after any prior surge. The seven-day average for newly admitted confirmed cases slid to 1,836 on Wednesday, down from a record that reached 22,000 in January, a Wall Street Journal analysis of federal data shows. The number of hospitalized Covid-19 patients is also nearing a post-surge low.

The American Medical Association informs us

With pregnancy typically comes a whole set of urgent concerns about health, yet despite the widely known threat of COVID-19 pregnant women are among the least likely to be vaccinated to protect against the disease’s most severe outcomes.

The low vaccination rate of pregnant women in the U.S. is concerning because of the increased risk of pregnancy complications due to SARS-CoV-2 infection, which include hospitalization and delivering a pre-term or stillborn infant. Two recent studies highlight the importance of COVID-19 vaccination to protect moms and their babies.

Published in JAMA, the research letter “Durability of Anti-Spike Antibodies in Infants After Maternal COVID-19 Vaccination or Natural Infection” shows that vaccination resulted in significantly greater antibody persistence in infants than in natural infection from SARS-CoV-2. At 6 months old, 57% of infants born to mothers whopu were vaccinated had detectable antibodies, compared with only 8% among infants born to moms infected with SARS-CoV-2.

Additionally, a new study from the Centers for Disease, Control and Prevention (CDC) showed that “infants whose mothers received two doses of an mRNA COVID vaccine during pregnancy are less likely to be admitted to the hospital for COVID in the first six months of their life,” Andrea Garcia, MPH, director of science, medicine and public health at the AMA, said during an episode of the “AMA COVID-19 Update” about supporting vaccination during pregnancy. “Overall, the researchers found that maternal vaccination was 61% effective at preventing infant hospitalization.”

From the federal employees benefits front, Fedweek explains how to perform a cost-benefit analysis of [important] survivor annuity choices facing federal and postal employees.

Also, the Office of Personnel Management announced “federal employees may now receive up to four hours of administrative leave to vote in federal, state, local, tribal, and territorial elections. OPM also announced that federal employees may now use up to four hours of administrative leave per year to serve as non-partisan poll workers or observers.”

From the public health front, the Food and Drug Administration “took additional actions [explained here] as part of the agency’s work to ensure any electronic nicotine delivery system (ENDS) products available for sale have demonstrated that marketing of the products is appropriate for the protection of the public health.”

From the healthcare business front —

Building on earlier search updates that helped users check for in-network providers and languages spoken in office, Google is launching new functionality in the coming weeks that will give users a list of available appointments when searching for a specific provider. 

Google is partnering with CVS’ MinuteClinic as well as online scheduling companies to support the new tool. It will initially roll out nationwide in English, but Jackie DeJesse, product manager at Google, said the project is still in the early stages and will continue to be developed over time. 

  • Becker’s Hospital Review reports

From plans to scale its direct-care delivery service to recruiting new leadership to head its healthcare ecosystem, Amazon continues to strengthen its healthcare presence. Here are six most recent healthcare moves from the company as reported by Becker’s.

1. Amazon Web Services is seeking a physician lead to join its healthcare industry team to engage with key leaders from various healthcare organizations to facilitate their adoption of AWS services for medical imaging, telemedicine and analytics.

2. Aaron Martin, former chief digital officer at Renton, Wash.-based Providence, is leaving the health system March 25 to join Amazon as a vice president of health.

3. Amazon Pharmacy created MedsYourWay, a discount savings card, to help Horizon Blue Cross Blue Shield of New Jersey, Blue Cross Blue Shield of Nebraska, Blue Cross Blue Shield of Alabama, Florida Blue, and Blue Cross and Blue Shield of Kansas members save on prescriptions.

4. Amazon Alexa partnered with Teladoc to get patients connected with physicians via Echo devices.

5. Amazon Web Services will support the effort to donate 50 Medtronic GI Genius intelligent endoscopy modules to facilities that primarily serve communities with low screening rates or where access to this technology is not currently available.

6. Amazon Care rolled out virtual health services nationwide and is preparing to launch in-person services for more than 20 new cities in 2022.

Midweek update

David Ermer–COVID-19, COVID-19 vaccine, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From the Omnicron and siblings front, The Wall Street Journal reports

The BA.2 variant of Covid-19 is a relation of the original Omicron variant known as BA.1, according to Theodora Hatziioannou, an associate professor of virology at Rockefeller University.

The two variants arose around the same time and come from the same ancestor strain. They have many mutations in common, but around 20 mutations differ between the two variants. The differences between this variant and BA.1 can be seen in the spike protein of the virus, Dr. Hatziioannou said.

This was the first time that two competing variants emerged in parallel, according to Mark Zeller, a genomic epidemiologist at the Scripps Research Institute in San Diego, Calif.

Viruses mutate all the time and diversification within a variant is normal. The earlier Delta variant comprised more than 200 sublineages before it was replaced by Omicron, according to Francois Balloux, director of the University College London Genetics Institute.

Becker’s Hospital Review adds

The omicron subvariant BA.2 accounts for more than 1/3 of COVID-19 cases nationwide and more than half of cases in the Northeast, according to the latest variant proportion estimates from the CDC. * * *

Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said he would not be surprised to see an uptick in infections in the U.S., though a major surge is unlikely. 

“The extent of it and the degree to which it impacts seriousness of disease like hospitalizations and death remains to be seen,” he told The Washington Post March 22. “I don’t really see, unless something changes dramatically, that there would be a major surge.”

The AMA Morning Rounds tells us

MedPage Today (3/22, Monaco) reports, “People with COVID-19 were more likely to be diagnosed with diabetes in the year following their infection, according to a cohort study using national Department of Veterans Affairs databases.” The study published in The Lancet Diabetes & Endocrinology found that “among 181,280 veterans who tested positive for COVID-19, there was a 40% higher risk for incident diabetes during the post-acute phase of the disease compared with a contemporary control group.” Also, over 12 months, there was “a significantly higher excess burden of new diabetes among those with a positive COVID test…the researchers wrote.”

From the Covid vaccine front the Wall Street Journal informs us

For kids ages 5 to 11, Pfizer and its partner BioNTech released data in the fall showing the vaccine was 90.7% effective at preventing symptomatic Covid-19. The companies also said the vaccine was safe during the testing.

For 12-to-18-year-olds, the vaccine was shown to be 93% effective against hospitalization with Covid-19, CDC researchers reported in the fall. 

A study published by the CDC in March showed that two doses of the Pfizer-BioNTech vaccine were protective against Covid-19-related emergency department and urgent care visits among children and adolescents.

“The vaccine is very effective at protecting against serious disease, hospitalization and death,” said Tina Tan, a pediatric-infectious-disease physician at Ann & Robert H. Lurie Children’s Hospital of Chicago.

Moderna said a new study found that its vaccine’s efficacy against symptomatic infections was 43.7% in children ages 6 months to 2 years, and 37.5% in children ages 2 to 5.

STAT News adds

Moderna announced Wednesday that [based on the above-referenced study] it will ask the Food and Drug Administration to authorize its Covid-19 vaccine for emergency use in children aged 6 months to 6 years, a group for which there are currently no authorized Covid vaccines.

From the medical research front, STAT News tells us

One lesson [from Covid research] is to only trust the most rigorous studies, known as randomized controlled clinical trials. But an equally important one: We need to get much better at conducting these rigorous studies more quickly and cheaply — and that goes beyond the Covid pandemic. This is not just a problem of science, but of infrastructure.

Last week, a clinical trial called TOGETHER produced two potentially important conclusions: A little-discussed experimental drug called peginterferon lambda cut in half the number of Covid-19 patients who ended up going to the emergency room or hospital. And the much-discussed antiparasitic drug ivermectin failed to prevent hospitalization for Covid patients at all.

TOGETHER, like the RECOVERY study conducted in the United Kingdom and REMAP-CAP, conducted basically everywhere but the United States, was a platform study, a streamlined clinical trial that evaluated multiple medicines at once and that use a common placebo group. It’s from these platform studies that doctors have learned perhaps the most about Covid-19.

Another STAT News article explains

Pancreatic cancer has proved one of the most deadly forms of the disease, and the most difficult to crack. It shrugs off immunotherapy drugs and resists chemotherapy, and only about 10% of patients live longer than five years after diagnosis.

But Albert Einstein College of Medicine immunologist and microbiologist Claudia Gravekamp is trying a new, unconventional approach: using Listeria bacteria to develop an immunotherapy that makes pancreatic tumors vulnerable to immune attacks. The resultsfrom her experiments in mice, published Wednesday in Science Translational Medicine, found the therapy can extend survival by 40% — a figure that experts said was very promising, though preliminary, and warranted further research in humans. 

“I’m extremely excited. [The result] feels terrific. We’re very close to a clinical trial,” Gravekamp said. She said the patent for the therapy has been licensed to the New York-based biotech company Loki Therapeutics, which plans to test the new therapy in humans. 

From the healthcare business front

Forbes informs us

Fertility Tech: Alife Health, a startup using artificial intelligence to improve the in-vitro fertilization process, has raised a $22 million Series A round led by Lux Capital, Union Square Ventures and Maveron. The funding will help bring its first two products to market: an AI tool for clinicians to help retrieve mature eggs from the ovary and a patient-facing app. It is also working on an AI tool to help select embryos, which is in the investigational stage. 

Heart Health: Recora Health emerged from stealth this week with $20 million in funding led by SignalFire for its cardiac care management program, which aims to engage patients at home with virtual tools and access to care teams. The company is currently serving 30,000 patients through partnerships with Geisinger and regional insurance plans. 

Healthcare Dive reports

[Health insurer] Centene has appointed Sarah London as its new CEO, effective immediately. She succeeds longtime leader Michael Neidorff, according to a filing with the Securities and Exchange Commission on Tuesday.

London, 41, joined Centene in 2020 from Optum and has a focus on data and technology. She has quickly ascended the ranks at Centene and recently was named vice chairperson. 

Neidorff remains on a medical leave of absence from his role as chairman of the company board.

Tuesday’s Tidbits

David Ermer–Federal employment benefits, OPM, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the government employment front,

Performance.gov informs us that OPM Director Kiran Ahuja is one of three Leads on implementing Priority One of the President’s Management Agenda — “Strengthen and Empower the Federal Workforce.” Good luck, Director Ahuja.

FedSmith identifies “ten steps federal employees should take at least a decade before retiring to ensure they are prepared to head into their golden years.”

Step 2 of 10 is “Enroll or Stay in FEHB.”

If you plan to continue your federal health benefits in retirement, you must be entitled to retire on an immediate annuity and:

be enrolled for the 5 years immediately before retiring or, during all your federal employment since your first opportunity to enroll if less than 5 years.

Coverage under FEHB, Tricare, or the Civilian Health and Medical Program of Uniformed Services (CHAMPUS) all count toward the 5 year requirement.

In yesterday’s post, the FEHBlog pointed out a Fierce Healthcare interview with the CEO of dialysis heavyweight, Davita. Today, Fierce Healthcare reports

Three big players in kidney care—Fresenius Health Partners, Cricket Health, and InterWell Health—plan to form a new value-based care company focused on services for the earlier stages of kidney disease.

The deal, announced Monday morning, will create a company valued at $2.4 billion, according to the companies.

The merger brings together expertise in value-based kidney care contracting of Fresenius Health Partners, a division of Fresenius Medical Care North America, InterWell Health’s network of more than 1,600 nephrologists and startup Cricket Health’s technology-enabled care model and patient engagement platform. Fresenius Medical Care is the world’s largest operator of dialysis centers.

Healthcare Dive delves into the case for hybrid care models, meaning the marriage of hospital systems and telehealth vendors.

Though the pandemic greatly accelerated the use of telehealth, use of pure-play virtual care has waned as COVID-19 cases drop off across the U.S. But telehealth is increasingly being woven into hospitals’ digital roadmaps, and some are even upping their investments in the modality despite moderating visits, experts said at the annual HIMSS healthcare conference.

That’s giving hope to proponents of hybrid care models, who point to the value of meeting patients where they are to lower costs and improve outcomes.

Intriguing.

Health Payer Intelligence reports

The National Committee for Quality Assurance (NCQA) has awarded [health insurer] Centene the Innovation Award for Health Equity for the company’s Health Equity Improvement model.

“Advancing health equity has a real and positive impact on the health of our members across the country,” said Sarah Bezeredi, senior vice president and chief quality officer for Centene. * * *

At its core, the model uses qualitative and quantitative data to target certain health equity gaps. Centene engaged communities and activated community coalitions in order to empower its strategy. The company’s approach included carefully selecting leaders who would help create and promote the model as well as soliciting community feedback.

In Arizona, Centene sent HbA1c at-home testing kits, which became a common method of chronic disease prevention during the pandemic. The kits were outfitted with a range of delivery modalities to cover the spectrum of members’ needs. Members also received telehealth and telemonitoring tools. The payer incentivized compliance with certain diabetes care measures.

The model tackled patient education in addition to delivering access to care interventions. Centene mailed qualifying members resources about the HbA1c test and comprehensive diabetes care measures.

The payer tracked progress using its Health Equity Dashboard, which leverages HEDIS data and other social determinants of health and demographic data to assess care disparities.

“By using a data-driven process, we are identifying disparity reduction opportunities and tracking performance and success year-over-year,” Bezeredi added. 

Mazaal Tov, Centene.

Monday Roundup

David Ermer–Congress, COVID treatment, COVID-19, U.S. Healthcare–
Photo by Sven Read on Unsplash

Readers — The FEHBlog wrote the Weekend Update post yesterday, but the publish button didn’t do the job. As a result, the Weekend update post was not emailed out yesterday but you can read it on our firm’s website.

From Capitol Hill, Roll Call updates us on Administration efforts to obtain additional Covid funding.

House Majority Leader Steny H. Hoyer, D-Md, said last week that lawmakers were looking at other previously appropriated pandemic funding that could be reallocated to pay for the $15.6 billion package lawmakers had agreed on.

The White House is urging Congress to pass the supplemental package [totallling $22.5 billion] without offsets, as it did with bipartisan support early in the pandemic.

But Republicans are unlikely to back any COVID aid package without sufficient offsets.

From the Omicron and siblings front —

  • The Wall Street Journal seeks to inform its readers about available Covid treatments.
  • Medscape explains why doctors are finding hurdles to use Covid pills to treat the disease. “Doctors hailed the pills as a huge advance in the fight against COVID-19 partly because of their convenience compared to other treatments that require infusions or injections. But patients can miss the pills’ short window if they dismiss symptoms like a headache or sniffles and wait [more than five days after symptoms present] to see if they go away before seeking help.” This appear to be where the test to treatment program can help, but where is promised website?

In other healthcare news —

  • Healthcare Dive considers what is holding up the widespread adoption of hospital at home programs.
  • Fierce Healthcare offers an interview with Javier Rodriguez, the CEO of the leading dialysis company DaVita.
  • Health Payer Intelligence discusses AHIP’s views on the advantages of applying value based care approaches to maternity services.

From the upcoming events front

  • AHIP informs us

The Office of Intergovernmental and External Affairs will host a virtual event on Tuesday, March 22nd – 3:30pm-4:30pm to hear from Josh Peck, Deputy Assistant Secretary for Public Engagement, about communications resources to encourage those who are eligible to get their COVID- 19 booster.

Deputy Assistant Secretary Peck will share background and information on how to access resources to support your efforts. Following the presentation there will be time for Q & A.

PEC Brief: Payers

Tuesday, March 22nd | 3:30 – 4:30 PM EDT

Zoom Meeting Link | Passcode: 591497 Meeting ID: 160 756 9170

Dial by your location

+1 669 254 5252 US (San Jose) +1 646 828 7666 US (New York) +1 551 285 1373 US

  • The Centers for Disease Control tells us

Tuesday, March 22nd is Diabetes Alert Day—an annual wake-up call to inform the public about the seriousness of diabetes. Did you know:

  • More than 37 million people in the United States have diabetes, and 1 in 5 of them don’t know they have it.
  • 96 million US adults have prediabetes, but more than 8 in 10 of them don’t know they do.
  • In the last 20 years, the number of adults diagnosed with diabetes has more than doubled as the American population has aged and obesity has increased.

If you have diabetes, you’re not alone! Join us on social media this Diabetes Alert Day to share your tips on living well with diabetes and learn what others are doing too.

WHO: We’ll be talking to our followers (that means YOU too) to hear their tips and strategies on managing diabetes, diabetes-friendly food hacks, and more!

WHEN: Tuesday, March 22nd from 9:30 AM to 5 PM ET.

WHERE: You can find us on Twitter or Facebook when you use or search for #TipsForDiabetes.

WHY: To spread awareness and connect with others who are living with diabetes.

Weekend Update

David Ermer–Congress, Federal employment benefits, Rx coverage, U.S. Healthcare–
Photo by Tomasz Filipek on Unsplash

Today has been the first day of Spring. But, it is the first day of Fall for my youngest son, who is studying medicine at Queensland University in Brisbane, Australia.

The House of Representatives is on a district work break this week. Meanwhile, the Senate will be engaged in committee business and floor voting on Capitol Hill.

Fedweek discusses the highlights of the call letter for 2023 benefit and rate proposal letters that OPM released last week.

OPM has told FEHB carriers to continue with increased levels of telehealth and other services related to the pandemic in the 2023 plan year, while also either ordering or encouraging them to expand benefits for certain other conditions.

While Fedweek gets the facts right, its article overlooks that OPM’s orders diminish FEHB competition which Congress relies upon to control premiums.

From the cost management front, Fierce Healthcare tells us

While prior authorization is a key tool in an insurer’s arsenal as it thinks about managing costs, the process remains a key source of friction with physicians.

Amid a nationwide conversation around addressing physician burnout and stress, plans are seeking ways to grow automated and virtual prior auth technologies to ease those barriers. At eviCore Healthcare, the benefit management arm of Cigna’s Evernorth subsidiary, the team has found one of the keys to success in this endeavor is bringing physicians into the conversation early on.

Eric Gratias, M.D., eviCore’s chief medical officer, told Fierce Healthcare that prior authorization programs are often built by people who, while well-intentioned, lack first-hand knowledge of what a clinical encounter is like.

The company’s own prior authorization technology, intelliPath, is built on collaboration with physicians who are actively practicing, he said.

“That partnership with our provider clients is absolutely critical for our success,” Gratias said.

Good point.

From the Rx coverage front

  • NPR Shots points out significant problems with the distribution of Covid treatments.

[D]ata on COVID treatment utilization, shared with NPR by the U.S. Department of Health and Human Services, indicates that millions of COVID treatments are sitting on shelves unused. 

“We are still in a public health emergency,” said Dr. Derek Eisnor, who leads the government’s distribution of COVID drugs, on a call with national health organizations on March 16. He urged health leaders to try to get the drugs to communities that have a demand for them, rather than let them go to waste. 

“There’s an assumption that there’s not enough of [these drugs] around but it does seem when you look at the numbers that there is a lot around — it’s just not being used,” says Dr. Amesh Adalja, an infectious disease physician and senior scholar at the Johns Hopkins Center for Health Security. “They clearly are not getting to people at high enough rates to have their maximum impact.” * * *

It can be hard to know which pharmacies have the pills in stock or which infusion clinics have appointments available. A patient needs to be able to quickly find a clinician, get a diagnosis and prescription, and be able to access the treatment, all within a few days. 

“It’s multifactorial why these drugs are underutilized,” Adalja says. “It’s likely all of those things are playing some role in the discrepancies between what’s been ordered and and what’s actually been administered.”

The Biden administration launched the Test to Treat initiative this month to address these gaps. “We know the challenges that are involved with patients obtaining therapeutics,” said Dr. Meg Sullivan, acting chief medical officer for HHS’ Office of the Assistant Secretary for Preparedness and Response, in a call with clinicians on March 12. The program aims to improve access to rapid testing and to bolster public and provider awareness of available COVID treatments and how to get them.

Here is a link to the HHS website that offers a U.S map that “displays public locations that have received shipments of U.S. Government-procured COVID-19 therapeutics under U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) authority. The long-acting antibody combination, Evusheld; monoclonal antibody treatments, bebtelovimab and sotrovimab; as well as the oral antiviral therapies, Paxlovid and molnupiravir are products authorized by the FDA for either prevention (Evusheld) or treatment (Paxlovid, sotrovimab, bebtelovimab, and molnupiravir) of COVID-19.   The locations displayed in the locator have reported available courses within the last seven days.”

The test to treat program’s website is not online yet as far as the FEHBlog can tell.

On March 30, the Food and Drug Administration is bringing together outside experts in neurology to review an experimental drug from Amylyx for the treatment of amyotrophic lateral sclerosis, or ALS. The hearing is expected to be closely watched by ALS patients and their advocates, given the significant need for new treatments for the disease.

But the hearing is likely to garner extra attention because it’s the first meeting of the FDA advisory group since it met in November 2020 and voted unanimously against the approval of Aduhelm, Biogen’s drug for Alzheimer’s disease. The FDA later ignored that recommendation and approved the medication, leading to the resignation of three members of the panel and an uproar over whether the agency had compromised its standards.

Sixteen months removed from all the Aduhelm drama, the Peripheral and Central Nervous System (PCNS) Drugs Advisory Committee, restocked with new members, is back to tackle another high-stakes review of a drug targeting a progressive, fatal nervous system disease. The Amylyx treatment — called AMX0035 — isn’t likely to generate the same acrimony as Aduhelm, but it could similarly force the FDA to bend its standards.

Here’s what you need to know about AMX0035, the data from its single clinical trial, and the issues that are likely to take center stage at the FDA advisory panel meeting.