Thursday Miscellany

Thursday Miscellany

Photo by Josh Mills on Unsplash

From the Capitol Hill front, today, the Senate took the following action

PN1166: Krista Anne Boyd, of Florida, to be Inspector General, Office of Personnel Management– Considered by Senate.– Confirmed by the Senate by Voice Vote.

And just like that, OPM has a Senate-confirmed Inspector General for the first time in over six years. The FEHBlog wishes Inspector General Boyd good luck.

The President issued a statement on World Health Day, which was celebrated today.

From the Omicron and siblings front —

  • The Centers for Medicare Services released an updated Toolkit on Covid Vaccines for health insurers and Medicare Advantage plans.

A federal appeals court has reinstated President Biden’s COVID-19 vaccine mandate for the federal workforce, overturning a lower court’s nationwide pause that had been in effect since January.

The plaintiffs who brought their suit over Biden’s executive order did not have standing in the federal circuit, a panel of the U.S Court of Appeals for the Fifth Circuit said in a 2-1 opinion Thursday evening, and instead must pursue their appeals through the Merit Systems Protection Board or Office of Special Counsel as laid out in the Civil Service Reform Act. The court vacated the injunction and instructed the district court in Texas that issued it to dismiss the case upon remand. 

From the Rx coverage front —

STAT News reports

Medicare on Thursday finalized its plan to restrict coverage for the controversial, pricey Alzheimer’s drug Aduhelm to patients participating in clinical trials.

The decision marks the end of an intense pressure campaign from drugmakers and some patient groups who wanted Medicare to reverse its initial proposal and pay for the drug for more patients. As clinical trials are usually run out of major medical centers, the decision will likely mean some interested patients won’t be able to access the drug. However, Medicare isn’t explicitly requiring that patients be treated at hospital-based clinics like the initial proposal.

The decision has implications beyond Aduhelm’s manufacturer, Biogen, as well. The coverage decision is not specific to Aduhelm, and applies to all drugs in the class, including a forthcoming treatment that Eli Lilly has begun to submit for FDA approval.

But in a major change from the initial proposal, Medicare officials created a sort of shortcut path for drugs that, unlike Aduhelm, demonstrate a clinical benefit for patients before they are approved. Medicare will cover those medicines for a broader group of patients.

They would still need to collect some data, but the possible design of the studies is much more flexible — a significant win for Lilly.

Here is a link to the CMS fact sheet on this decision.

U.S. News adds “Medicare said Thursday it’s considering a cut in enrollee premiums after officials stuck with an earlier decision to sharply limit coverage for a pricey new Alzheimer’s drug projected to drive up program costs.” Given Medicare’s shaky financial condition, one would expect the government to build up reserves with the additional cash and then adjust the premium for the following Medicare year, taking all considerations into account.

From the No Surprises Act front, AHIP released a new resource reflecting on the first 100 days of the NSA.

From the healthcare business front, Fierce Healthcare informs us

[Blue Cross of California and Walgreen] are launching new Health Corners in 12 Walgreens stores in the San Francisco Bay area and Los Angeles County.

At the Health Corner locations, Blue Shield members and customers will be able to connect with health advisers who can offer simple in-store care as well as assistance with preventive screenings, chronic care management and medications. The health advisers have clinical backgrounds, such as pharmacists or nurse practitioners.

The partnership seemed a natural fit, D.D. Johnice, vice president of the Health Transformation Lab at Blue Shield of California, said in an interview. * * * Some 80% of people in California live within five miles of a Walgreens store, she said, so the Health Corners could be a valuable tool for reaching people who live in healthcare deserts, or more specifically, Blue Shield network deserts.”

In sad news, the Wall Street Journal reports

Michael F. Neidorff, who as chief executive officer of Centene Corp. transformed a tiny medical insurance firm serving three counties in 1996 into a nationwide giant in government-backed health coverage, died Thursday after what his family described as a long illness. He was 79.

Mr. Neidorff recently took medical leave and had signaled last year a plan to retire in 2022 from the CEO job he held for more than 25 years. Centene announced in March the appointment of Sarah London, who had been vice chairman, to succeed him as CEO.

St. Louis-based Centene is the biggest company in managed Medicaid, contracting with states to provide coverage to people enrolled in the program for lower-income Americans.

Centene offers FEHB HMO coverage through its Health Net subsidiary. RIP.

Midweek update

The Postal Service Health Benefits Program was born today as the President signed into law the Postal Reform Act of 2022 (H.R. 3076). Here is a link to the President’s remarks made at the bill signing.

The PSHBP will become operational on January 1, 2025. OPM’s implementing rules must be finalized by April 6, 2023.

Govexec adds

The U.S. Postal Service is once again seeking to raise its rates by historically unusual amounts, announcing the increases on the same day President Biden signed into law a bipartisan bill to erase much of the agency’s debts and allow it to pursue new lines of revenue.  * * *

The new prices, which are set to go into effect July 10, would raise rates for regular, First-Class mail by 6.5% and by 8.5% for package services. A standard stamp would go from $0.58 to $0.60. The large increases were made possible under new authority the Postal Service’s regulator granted it in 2020 and which USPS employed for the first time last year. DeJoy promised as part of his 10-year business plan to use his authority to raise rates above inflation “judiciously,” but predicted USPS would generate between $35 billion and $52 billion by 2031 by raising prices.

From the Capitol Hill front, Roll Call reports “A bipartisan $10 billion COVID-19 supplemental is stuck in the Senate amid a dispute over a tangential pandemic-related border control policy, with both parties at a loss on how the impasse will be resolved.”

In other Omicron (and siblings) news

The Food and Drug Administration’s Vaccine and Biological Products Advisory Committee met today for a general discussion of Covid vaccines. The Wall Street Journal reports

A top U.S. health regulator said that asking people to frequently get Covid-19 boosters wasn’t sustainable because of vaccine fatigue and that authorities needed to develop a long-term strategy for protecting the public from the virus as it evolves.

Dr. Peter Marks, who heads the Food and Drug Administration’s vaccines division, said that last week’s authorization of a second booster dose for people 50 years and older and for people 12 and older with weakened immune systems was a stopgap.

STAT News offers a play-by-play account of that meeting here.

The American Hospital Association informs us

Medicare and Medicaid will cover a second Pfizer or Moderna COVID-19 booster at no cost to eligible enrollees, the Centers for Disease Control and Prevention announced today. Health care providers participating in the Centers for Disease Control and Prevention’s COVID-19 Vaccination Program also must provide authorized COVID-19 vaccines at no cost to recipients.

The FEHBlog discovered from reading an AHA squib that CDC Director Rochelle Wolensky approved the FDA’s March 29 second booster recommendation last week. That joint recommendation permits adults aged 50 and older to receive a second Pfizer or Moderna COVID-19 vaccine booster dose at least four months after an initial booster dose. In addition, those agencies authorized and recommended a second Moderna booster dose for certain immunocompromised adults and a second Pfizer booster dose for certain immunocompromised individuals aged 12 or older.”

What’s odd is that the ACA FAQ 50 indicates that the CDC advisory committee’s recommendation triggers the health plan to cover a particular use of a Covid vaccine with no member cost-sharing. Given that CMS has given the green light and the advisory committee reports to the CDC Director, the FEHBlog concludes that health plans also should step up to the plate and provide no cost-sharing coverage for these second boosters.

STAT Health tells us that

A new survey by STAT and The Harris Poll finds six in 10 Americans have already decided they will get another booster if it’s recommended for them.

Just under one-quarter of U.S. adults indicated they will only receive a second booster shot if a new variant arises or there is a surge in Covid-19 cases in their area, and 18% have no plans to get a booster at all, according to the survey, which polled 2,028 U.S. adults between March 25 and 27.

America has spoken.

From the No Surprises Act front, the AHA notes

The Centers for Medicare & Medicaid Services has released a new FAQ for health care providers on the No Surprises Act’s requirements and prohibitions, and the independent dispute resolution process; and a new FAQ on providing good faith estimates to uninsured and self-pay patients. CMS plans to launch next week the online portal through which uninsured and self-pay patients may initiate the dispute resolution process.

The CMS FAQs are worth reviewing by health plans because they go beyond the out-of-network bill consumer protections to address the NSA good faith estimate, continuity of care, and provider directory accuracy provisions. For example, the good faith estimate discussion on page 6 is quite informative.

From the Health Affairs front

  • Jane Zhu and a team of fellow experts wrote an article on Trends in Outpatient Mental Health Services Use before and during the pandemic. Here are excerpts from the abstract which is quite pro-telemental care.

In-person mental health encounters were reduced by half in the early months of the pandemic, with rapid recovery of service delivery attributable to telehealth uptake (accounting for 47.9 percent of average monthly encounters). We found variation in the degree to which telehealth use increased across groups: People with schizophrenia made up a lower proportion of telehealth encounters relative to in-person visits (1.7 percent versus 2.7 percent), whereas those with anxiety and fear-related disorders accounted for a higher proportion (27.5 percent versus 25.5 percent). These findings highlight the importance of broadening access to services through new modalities without supplanting necessary in-person care for certain groups.

  • Joshua Liao and Amol Navathe wrote an article in the Health Affairs Forefront describing a new Accountable Care Organization model designed to improve health equity.

From the healthcare business front —

Optum continues its buying spree and has picked up Kelsey-Seybold Clinic, a large, multi-specialty group practice based in Houston, Texas, Axios reported Monday.

With more than 500 physicians, Kelsey-Seybold Clinic operates multi-specialty care centers, a cancer center, a women’s health center, two ambulatory surgery center locations, and a specialized sleep center with more than 30 locations in the Greater Houston area. Kelsey-Seybold partners with major insurers to offer value-based commercial health plans. Kelsey-Seybold partners with major insurers to offer value-based commercial health plans. The organization partners with payers to offer value-based commercial health plans also owns its own Medicare Advantage plan for seniors, KelseyCare Advantage.

Intermountain Healthcare and SCL Health completed their merger, creating one of the nation’s largest nonprofit health systems, the two organizations announced Tuesday.

The new system, which will use the Intermountain name to reflect the parent entity, will operate 33 hospitals and hundreds of clinics across seven states and insure 1 million people in Utah and Idaho.

Colorado’s attorney general signed off on the merger last week after conducting a review, concluding the tie-up will not result in a material change to the charitable purposes of nonprofit SCL Health, based in Colorado, and that SCL assets will not leave the state.

  • Business Wire tells us “Millennium Trust Company, LLC (“Millennium Trust”), a leading provider of retirement and financial services for employers, institutions, advisors, and individuals, today announced it has signed a definitive agreement to acquire PayFlex Holdings, Inc. (“PayFlex”), a provider of health savings accounts (HSAs) and consumer-directed benefit administration services, from CVS Health Corporation (“CVS Health”).

In HIPAA Privacy and Security Rule News, the Department of Health and Human Services announced issuing

a Request for Information (RFI) seeking input from the public on two requirements of the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act), as amended in 2021.  The growing number of cybersecurity threats are a significant concern driving the need for enhanced safeguards of electronic protected health information (ePHI).  This RFI will enable OCR to consider ways to support the healthcare industry’s implementation of recognized security practices. The RFI also will help OCR consider ways to share funds collected through enforcement with individuals who are harmed by violations of the HIPAA Rules.

* * *

Individuals seeking more information about the RFI or how to provide written or electronic comments to OCR should visit the Federal Register to learn more: https://www.federalregister.gov/documents/2022/04/06/2022-07210/considerations-for-implementing-the-health-information-technology-for-economic-and-clinical-health

Please note that comments must be submitted by June 6, 2022 in order to be considered.

Interestingly, the HHS seeks public input on developing the safe harbors created by the 2021 law.

Friday Stats and More

Based on the Centers for Disease Control’s Covid data tracker and using Thursday as the first day of the week, here are the FEHBlog weekly charts of new Covid cases and deaths from the 27th week of 2021 through the 13th week of 2022:

The CDC weekly review of its Covid data adds

Currently, there are 19 (0.59%) counties with a high COVID-19 Community Level, 146 (4.53%) counties with a medium Community Level, and 3,059 (94.88%) counties with a low Community Level. This represents a slight (−0.84%) decrease in the number of high-level counties, a moderate (−2.73%) decrease in the number of medium-level counties, and a corresponding (+3.57%) increase in the number of low-level counties. Twenty-seven (48.21%) of 56 jurisdictions had no high- or medium-level counties this week. To check your COVID-19 community level, visit COVID Data Tracker.

* * *

The current 7-day daily average [of new Covid hospital admissions] for March 23–29, 2022, was 1,564. This is a 15.8% decrease from the prior 7-day average (1,858) from March 16–22, 2022. * * *

The current 7-day moving average of new [Covid] deaths (627) has decreased 14.4% compared with the previous 7-day moving average (732).

Here’s a link to the FEHBlog’s weekly chart of new Covid vaccinations distributed and administered from the beginning of the Covid vaccination era until last Wednesday.

The CDC’s weekly review notes

As of March 30, 2022, the 7-day average number of adhttps://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.htmlministered vaccine doses reported (by date of CDC report) to CDC per day was 214,405, a 17.8% increase from the previous week.

CDC’s COVID Data Tracker displays vaccination trends by age group, race/ethnicity, and urban/rural status. To see trends by age group and race/ethnicity, visit the Vaccination Demographic Trends tab. To see trends by urban/rural status, visit the COVID-19 Vaccination Equity tab.

The American Medical Association offers guidance to physicians concerning the FDA’s emergency authorization of a second Covid booster for Americans aged 50 and older.

HR Dive discusses what employers should take away from the Biden Administration’s updated approach to Omicron.

Here’s a link to the CDC’s weekly flu surveillance report or Fluview.

From the “and more” department —

  • HR Dive discusses what employers can do to help employees with adolescent children suffering from behavioral health issues. For example, because a shortage of child psychiatrists exists,

Telemental health programs offer convenient access (often at lower cost than in-person care) for many services—and some, like Brightline, are designed specifically for families of children with mental health needs. However, recent studies have shown that telehealth offerings are not being utilized as much for children as they are for adults, for rural populations as they are for urban ones, or for low-income communities as they are for wealthier ones. Clearly, there is an opportunity for employers to make vulnerable populations aware of the telemental health services available to them. 

  • BioPharma Dive identifies “Five FDA decisions to watch in the second quarter. Between April and June, the agency will advance key regulatory reviews in ALS and gene therapy as well as host an advisory meeting on cancer drugs.”

Thursday Miscellany

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.”

Tuesday’s Tidbits

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

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

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

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

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.

Friday Stats and More

Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s latest weekly charts of new Covid cases and deaths (a lagging indicator):

The CDC observes in its weekly review of its Covid statistics

COVID-19 caseshospitalizations, and deaths all continue to decrease in the United States. According to CDC’s COVID Data Tracker, as of March 16, 2022, 76.7% of the total U.S. population has received at least one dose of a COVID-19 vaccine, and 65.3% has completed their primary series. However, only about half of the booster-eligible population has received a booster dose and is considered up to date on their COVID-19 vaccines.

Two new studies show the effectiveness of COVID-19 vaccines and boosters across periods of three variants of concern (Alpha, Delta, and Omicron). CDC released a study today showing that, among adults hospitalized with COVID-19 during the Delta and Omicron waves, those who received two or three doses of the Pfizer-BioNTech or Moderna vaccine had 90–95% less risk of dying or needing a ventilator compared with adults who were not vaccinated. Protection was highest in adults who received a third COVID-19 vaccine dose. A study published in the British Medical Journalexternal icon found that vaccines gave a high level of protection against hospitalization for all variants, but not as much for Omicron among adults who received only a primary series. However, boosters increased protection against Omicron. The study also showed that hospital patients who were vaccinated had much lower disease severity than patients who were not vaccinated.

These studies emphasize the importance of staying up to date with vaccinations—they are our best protection against severe COVID-19 illness. Vaccination is also the safest way to reduce the chance that new variants will emerge. Find a vaccine provider and get your booster dose as soon as you can.

In that regard, here is the FEHBlog weekly chart of Covid vaccinations distributed and administered from the beginning of the vaccination era in late 2020:

Here’s a link to the Food and Drug Administration’s March 18 round of its Covid related activities.

While the bulk of Covid care spending goes to hospitals, Becker’s Hospital Review reports that a “sizable minority” have a significant amount out-of-pocket spending for this care, according to a study published in the American Journal of Managed Care March 16.”

It’s worth adding that the Wall Street Journal reports that

The biggest credit-reporting firms will strip tens of billions of dollars in medical debt from consumers’ credit reports, erasing a black mark that makes it harder for millions of Americans to borrow.

Equifax Inc.,  Experian  PLC and TransUnion are making broad changes to how they report medical debt beginning this summer. The changes, which have been in the works for several months, will remove nearly 70% of medical debt in collections accounts from credit reports.

Beginning in July, the companies will remove medical debt that was paid after it was sent to collections. These debts can stick around on a consumer’s credit report for up to seven years, even if they are paid off. New unpaid medical debts won’t get added to credit reports for a full year after being sent to collections.

The firms are also planning to remove unpaid medical debts of less than $500 in the first half of next year. That threshold could rise, according to people familiar with the matter.

From the compliance front —

  • The Internal Revenue Services issued a notice on how to calculate the No Surprises Act’s Qualified Payment Amount when the health plan does not have enough data to calculate a January 2019 median.
  • The Department of Labor is offering a webinar on March 30 at 11 am that “will help employers, service providers, and benefit professionals understand how the provisions of [the federal mental health partity act] apply to employer-sponsored group health plans and provide information on how to avoid common problems. The webinar runs about 45 minutes to an hour and is limited to 200 participants.

From this week’s healthcare conferences front

  • Fierce Healthcare discusses the electronic medical records interoperability theme of the HIMSS conference.
  • Fierce Healthcare also offers a wrap report on “the most interesting innovations at SXSW 2022: From holograms to the future of psychedelics.”

From the telehealth front

  • Becker’s Payer Issues reports that most consumer driven plans have taken advantage of the IRS offered flexibility to cover telehealth before the “high” annnual deductible.
  • Forbes informs us “Telehealth Accounts For One In Three Mental Health Visits Two Years Into Pandemic.” Whoopee.

From the good works department, the American Medical Association tells us about a North Carolina physician who is talking the diabetes problem.

Dr. [Brian] Klausner is the medical director of WakeMed’s Community Population Health program in Raleigh. He also is a physician champion for DiabetesFreeNC. That is the statewide initiative where AMA partnered with the North Carolina Medical Society and others to support collaborative efforts to end type 2 diabetes in the Tar Heel State.  

Rather than think of the pandemic as having “derailed” diabetes prevention or other population health efforts, Dr. Klausner said that “COVID-19 expedited new perspective in how we can do a better job addressing historic roadblocks to community health initiatives, including those related to diabetes and prevention.”