Thursday Miscellany

Thursday Miscellany

Photo by Josh Mills on Unsplash

From Capitol Hill, Fierce Healthcare reports

Several bipartisan senators are clamoring for more transparency into how pharmacy benefit managers conduct their business, potentially foreshadowing action on legislation to require new disclosures for the industry.

A subcommittee of the Senate Commerce Committee held a hearing Thursday on PBMs and their role in the pharmaceutical marketplace. Senators claimed there is an absence of competition in the industry and potential conflicts of interest.

“PBMs are not the only cause of drug price inflation and excessive pricing, but they are integral to this system,” said Sen. Richard Blumenthal, D-Connecticut, the subcommittee’s chairman. “They are part of an increasingly integrated, uncompetitive system involving PBMs owned or owning insurers and constraining pharmacies in the amount of information that they give to consumers. That is one slice of a broken system.”

Healthcare Dive informs us

Members of the healthcare industry are once again pressuring Congress to remove what they say is a major pain point in their operations and in the delivery of patient care: the ban on a nationwide unique patient identifier.

Almost 120 health IT groups, EHR vendors, hospitals, physicians and health insurers sent letters on Wednesday to House and Senate appropriators urging them to remove decades-old rider language in a 2023 appropriations bill that prevents the HHS from spending federal dollars to create or adopt a UPI standard.

Signees, including payer lobby AHIP, software companies Cerner and Epic, and health systems Banner Health and Intermountain, called the ban “archaic” in the letters. However, regulators have noted a UPI is unlikely to be a silver bullet against the nation’s patient matching problem.

The patient identifier strikes the FEHBlog as a key to interoperability as well as improving patient safety. Fund it, Congress!

From the Omicron and siblings front, Medpage Today reports

Use of Johnson and Johnson’s (J&J) COVID-19 vaccine should only be limited to certain adults, the FDA said on Thursday.

Due to an updated analysis of the rare cases of thrombosis with thrombocytopenia syndrome (TTS), which typically occur 1 to 2 weeks after vaccination, use of the J&J vaccine should be restricted to those for whom mRNA vaccines are “not accessible or clinically appropriate,” or who would not get vaccinated if not for the J&J vaccine, the agency said.

It’s unfortunate that the only one-shot vaccine, which helped public health authorities reach underserved communities, is now knocked down for the mandatory eight count.

From the healthcare innovations front, Fierce Healthcare informs us

UnitedHealthcare has partnered with Kaia Health on a new virtual physical therapy program.

The program aims to offer 24/7, on-demand exercise feedback to eligible members with musculoskeletal conditions, the health insurance giant said. Members who are recovering from surgery or an injury will be asked to complete an assessment of current issues and will be referred to the program based on that assessment.

Eligible members will then be able to download Kaia’s app to access its physical therapy tools, which use artificial intelligence to support patients through physical therapy exercise and monitor progress.

and

Cigna is launching a new provider consult service that aims to improve outcomes for patients with cancer.

The program, backed by the capabilities of the insurer’s Evernorth subsidiary, allows community oncologists to connect with cancer subspecialty experts at centers designated by the National Cancer Institute (NCI). These connections will allow patients to benefit from the latest innovations in cancer care while also keeping their care close to home, Cigna said.

In a pilot, community oncologists had their treatment plans reviewed by experts and in 40% of cases reviewed, patients were recommended alternative tests or treatment based on new advancements in research.

Also a ZDNet reporter discusses his experience of wearing a continuous glucose monitor for 40 days.

I learned a lot about my body and how it reacts, and that’s information I can and do still use on a daily basis even if I don’t have an app yelling at me. Since I stopped wearing the Signos and getting insight, I’ve stuck to a healthier diet and routine exercise.

Good read.

From the healthcare business front, Healthcare Dive tells us

Centene said Thursday it has inked separate agreements to sell two of its pharmacy businesses in deals totaling $2.8 billion.

The payer plans to sell Magellan Rx to Prime Therapeutics and Pantherx to The Vistria Group, General Atlantic and Nautic Partners.

The deals are subject to regulatory approval. Magellan Rx is expected to close in the fourth quarter while Pantherx is anticipated to close in the next two to four months.

Thursday’s news builds on Centene’s plan to sell off non-core assets as it looks to sharpen its focus on its main [health insurance] business.

From the federal employment front, Govexec identifies the agencies who scored best and worst on the key employee morale questions of the recently released OPM 2021 Federal Employee Viewpoint Survey.

The National Science Foundation, Federal Energy Regulatory Commission, General Services Administration and the Pension Benefit Guaranty Corporation each landed in the top five on questions related to employees’ job satisfaction, senior leaders’ ability to motivate the workforce, and whether employees believe their agency will use Federal Employee Viewpoint Survey results to improve the workplace.

On the other hand, four agencies found themselves consistently near the bottom on these same questions. The Homeland Security Department, Social Security Administration, as well as the Justice and State departments all found themselves in the bottom five of at least two of these three questions.

Midweek update

Photo by Thought Catalog on Unsplash

From the Omicron and siblings front

The American Hospital Association informs us

COVID-19 vaccinations prevented an estimated 107,000 Medicare hospitalizations between January and May 2021, resulting in $2.6 billion in savings for Medicare and Medicare Advantage plans, according to a new report by the Department of Health and Human Services. The report estimates the impact of COVID-19 vaccination during a five-month period shortly after the first vaccine was authorized and recommended for health care workers and elderly people in long-term care facilities. Future analyses will examine hospitalizations prevented by vaccination during the delta and omicron waves, HHS said.

Bloomberg Prognosis tells us

Pfizer Inc. executives said patients who suffer a relapse in Covid-19 symptoms after taking a full course of Paxlovid should take more of the treatment, though current U.S. guidelines limit use to five consecutive days.

“Paxlovid does what it has to do: it reduces the viral load,” Chief Executive Officer Albert Bourla said in an interview. “Then your body is supposed to do the job.” But for unknown reasons, the CEO said, some patients aren’t able to clear the virus with the first course of treatment.

In cases where virus levels do rebound, Bourla said, “then you give a second course, like you do with antibiotics, and that’s it.”

As noted in the article, the fly in the ointment is that the FDA emergency use authorization does not expressly approve a second course of the medication.

From the Rx coverage front

MedCity News reports on Bristol Myers Squibb’s (BMS) NEX-T program to improve CAR-T treatments.

The company has described NEX-T as changes to manufacturing driven by the translational insights it has gleaned from treating thousands of patients with its CAR T therapies. In addition to a faster turnaround time, the strategy is intended to reduce the costs of the overall process.

One of the key goals for the next-generation of cell therapies is treating solid tumors.

Another strategy that BMS is pursuing is going after two targets with a single therapy, reducing the risk that a tumor escapes from the treatment

Looking at the flip side of this coin, Forbes reports

Health plans and pharmacy benefit managers (PBMs) that manage drug costs speaking at this year’s Asembia Specialty Pharmacy Summit in Las Vegas say specialty drugs now account for 50% or greater of the total prescription spending they manage. In some cases, employer clients are seeing specialty costs account for 60% or even greater of their total drug spending.

“It really is frightening for our clients,” Lucille Accetta, senior vice president of pharmacy benefit management and specialty product development at CVS Health told hundreds of attendees at the Asembia event, which runs through Thursday and drew more than 5,000 people from the healthcare industry. “We have to be the best purchaser for our clients.” * * *

To reign in the costs of prescription drugs while maintaining access to life-saving treatments, health plans and pharmacies say they are more closely monitoring patients as soon as they are on the drug, said Rina Shah, group vice president of pharmacy operations and services at Walgreens.

The Forbes article adds

Abarca Health [is] an independent PBM that manages more than $5 billion in drug costs annually for more than four million Americans has executives at this week’s Asembia meeting talking up its efforts to better manage specialty pharmacy costs.

The company’s Assura solution launched earlier this year “guarantees the net cost of drugs, including specialty medications, by offering an annual fixed per script cost for a health plan’s entire population,” Abarca said in announcing the new pricing solution earlier this year. The guarantee, Abarca CEO Jason Borschow says, is adjusted each year based on drug benefit coverage changes.

From the healthcare business front

Healthcare Dive informs us

Even as COVID-19’s benefit waned, new plan members across multiple product lines helped drive CVS to $2.3 billion in profit in the first quarter, slightly higher than the $2.2 billion brought in at the same time last year.

In results published Wednesday, the company beat Wall Street expectations on earnings and revenue, with a topline of $76.8 billion, up 11% year over year.

Fierce Healthcare explains how CVS has shifted from a retail to a digital marketing focus.

The Wall Street Journal reports

Moderna Inc. MRNA 5.81% said that its first-quarter revenue and profit tripled from a year earlier on higher sales of its Covid-19 vaccine and that a fall booster-shot campaign could drive continued sales gains.

The biotechnology company’s revenue topped $6 billion in the period ended March 31, beating analyst expectations and rising from $1.94 billion a year earlier, driven almost entirely by sales of its messenger RN

Moderna Inc. MRNA 5.81% said that its first-quarter revenue and profit tripled from a year earlier on higher sales of its Covid-19 vaccine and that a fall booster-shot campaign could drive continued sales gains.

The biotechnology company’s revenue topped $6 billion in the period ended March 31, beating analyst expectations and rising from $1.94 billion a year earlier, driven almost entirely by sales of its messenger RNA-based vaccine, branded as Spikevax. * * *

Moderna is the latest drugmaker to show surging sales due to demand for Covid-19 vaccines and treatments, following recent reports fromEli Lilly & Co., Merck & Co. and Pfizer Inc.

From the health risks front, MedPage Today explains that

Seven risk factors, some modifiable and some not, accounted for the vast majority of risk for first-time acute myocardial infarction (MI) in young adults, according to a case-control study.

The seven factors — diabetes, depression, hypertension, smoking, family history of premature MI, low household income, and hypercholesterolemia — were responsible for 83.9% of the total acute MI risk in young women and 85.1% of the risk in young men, reported Harlan Krumholz, MD, SM, of Yale New Haven Hospital in New Haven, Connecticut, and colleagues.

The UPI reports

Older adults who obtain a flu shot are less likely to suffer a heart attack or stroke and are at lower risk for death from heart-related health events in the year after getting vaccinated, an analysis published Friday found.

Just under 4% of older adults vaccinated against the seasonal virus experienced a “cardiovascular event” within the next year compared to just over 5% of those who did not receive the shot, data published Friday by JAMA Network Open showed.

From the meetings department,

  • HHS provides a readout of a high-level meeting among Labor Department, health insurance and business executives “to discuss compliance with the Mental Health Parity and Addiction Equity Act, adequacy of in-network providers and mental health and substance use disorder treatment during the pandemic, as the nation observes Mental Health Awareness Month.”
  • The National Committee for Quality Assurance reviews the presentations at last week’s Quality Talks conference.

From the federal employee benefits front, FedWeek discusses OPM’s planned improvement to processing retirement applications as unveiled in the Fiscal Year 2023 budget document. Processing federal retirement benefits will be a heavy lift for OPM until Congress simplifies the pension calculation.

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From the Omicron and siblings front, Fortune Well explores earlier pandemics for similarities to our current one.

As U.S. COVID czar Dr. Anthony Fauci and colleagues pointed out in a 2009 New England Journal of Medicine article, “It is not generally appreciated that descendants of the H1N1 influenza A virus that caused the catastrophic and historic pandemic of 1918–1919 have persisted in humans for more than 90 [now 100] years and have continued to contribute their genes to new viruses, causing new pandemics,” including the 2009 H1N1 “swine flu.”

“We are living in a pandemic era that began around 1918,” they wrote 13 years ago—long before the advent of COVID-19.

Harald Brüssow, editor of Microbial Biotechnology, agrees with Fauci and his colleagues that “viruses do not simply disappear.”

“They change and hopefully they adapt and behave,” Brüssow said. “But there are still some escapes, and we might see a return with higher virulence. Vigilance is indicated.”

From the healthcare business front —

The Wall Street Journal reports

Pfizer Inc. expects demand for its Covid-19 antiviral drug to increase as governments return to replenish their supplies and seek to thwart surges as the pandemic virus continues to evolve.

The treatment, a pill called Paxlovid, brought in $1.5 billion in sales during Pfizer’s first quarter, while its vaccine totaled $13.2 billion, reflecting the need for tools to combat the virus despite a slowdown in cases and a growing sense of life trying to return to normal.

The company said Tuesday it is on track to deliver between $98 billion and $102 billion in revenue for the year, with $32 billion coming from its Covid-19 vaccine Comirnaty and $22 billion from Paxlovid. 

“We remain bullish on Paxlovid” said Chief Financial Officer Frank D’Amelio on a call discussing earnings with analysts. “The rhythm of that product looks very good.”

STAT New informs us

Biogen is replacing CEO Michel Vounatsos, the company said Tuesday, ending a five-year tenure in which he presided over the disastrous approval and rollout of its Alzheimer’s treatment, Aduhelm.

The company also said it is “substantially eliminating” all spending on Aduhelm just 10 months after securing U.S. approval — a concession from the struggling biotech that the drug had become a financial liability following a Medicare decision to restrict patient access and payment.

From the Affordable Care Act front, Health Affairs Forefront features the third and final part of Katie Keith’s series on the final 2023 notice of benefit and payment parameters. The third part discusses changes to the ACA marketplace’s risk adjustment program.

From the No Surprises Act, the FEHBlog had understood that the NSA regulators planned to release a final rule on the NSA’s arbitration process, replacing the interim final rule, this month. However, a Justice Department filing with the U.S. Court of Appeals for the Fifth Circuit submitted late last week states, “the Departments expect to issue a final rule early this summer that will supersede the portions of the interim final rule that Plaintiffs [in the Texas Medical Association case] challenged.” No wonder then that the final rule has not been presented yet to OMB’s Office of Information and Regulatory Affairs for its required review before publication in the Federal Register.

From the tidbits department —

  • Here is a link to the new CMS Strategic Plan.
  • Federal News Network tells us,

Agencies’ hiring efforts for the Bipartisan Infrastructure Law (IIJA) are “foot to the pedal,” OPM Director Kiran Ahuja said in an exclusive interview with Federal News Network.

The surge includes filling 3,000 of those new positions over the first six months after President Joe Biden signed the bill into law.

Ahuja has frequently spoken about her goals to attract more early-career workers to federal service. The BIL gives OPM another chance to do just that.

  • FedSmith identifies four personal budget factors Federal retirees must anticipate. One of those factors is our beloved FEHBP.
  • The CDC offers ten tips for coping with diabetes distress.

Monday Roundup

Photo by Sven Read on Unsplash

The President has declared May 1 through May 7 to be Public Service Recognition Week. OPM explains

Celebrated annually during the first week of May since 1985, Public Service Recognition Week (PSRW) (external link) is time set aside to honor the men and women who serve our nation as federal, state, county and local government employees. 

Throughout the country, mayors, governors, agency leaders, communities and public service organizations participate in PSRW by issuing proclamations; hosting award ceremonies and special tribute events; and delivering messages about the value of public service.

To that end, Govexec reports the President took the time today to virtually award Presidential Rank Awards to 230 senior federal employees from 37 agencies.

Speaking directly to the career civil service, Biden said: “Over the last 15 months you’ve helped us deliver so much to the American people,” such as the getting Americans vaccinated against COVID-19, delivering economic relief checks, caring for veterans, implementing the infrastructure package and working to restore the public’s faith in government and democracy. He gave a big “thank you” to them as well as their families. 

The FEHBlog heartily agrees.

From the Omicron and siblings front, WebMd informs us

The FDA’s independent panel of advisors will meet in June to discuss the Pfizer and Moderna COVID-19 vaccines for children under age 5, as well as the Novavax vaccine for adults, according to an FDA announcement released Friday.

On June 7, the FDA’s vaccine committee will review the Novavax shot, which could become the first new COVID-19 vaccine to hit the U.S. market in more than a year. The shot is already authorized in more than three dozen countries, including across Europe.

The FDA has also selected three possible dates — June 8, 21, and 22 — to discuss the shots for kids under age 5. The dates are tentative because the companies haven’t completed their submissions, the agency said.

The FEHBlog is pleased to read about these developments because the Novovax shot which uses a traditional vaccination approach may be acceptable to the vaccine inquisitive and the country needs a vaccine for younger children.

STAT News adds

Pfizer released news late Friday that Paxlovid, the antiviral currently subject to a big push from the U.S. government, failed to prevent people living with Covid patients from catching the infection.

The news is one of several bad headlines for the new Covid pill, but one experts say doesn’t affect the medicine’s primary use: treating people who are already sick.

Paul Sax, clinical director of the division of infectious diseases at Brigham and Women’s Hospital, said he would “absolutely” prescribe Paxlovid to people at high risk of severe disease who have Covid. “Without hesitation,” he said. “Because the net benefit in the high risk study was extremely high.”

From the Affordable Care Act front, Health Affairs Forefront has posted the second part of Katie Keith’s three-part series on last week’s HHS final 2023 notice of ACA benefit and payment parameters. The second part concerns changes specific to the ACA marketplace or exchange plans.

From the Rx coverage front, Health Affairs informs us

UnitedHealthcare is restricting insurance coverage of Aduhelm across all of its health plans, saying the drug “is unproven and not medically necessary for the treatment of Alzheimer’s disease due to insufficient evidence of efficacy,” according to the company’s new policies.

Physicians who plan on giving Aduhelm to UnitedHealthcare patients will need to obtain prior approval from the insurance company, effective June 1. Patients also need to be in an approved clinical trial.

UnitedHealthcare’s decision follows Medicare, which said last month it would only pay for the costly infusion drug for patients who participate in a clinical trial. UnitedHealthcare is the largest Medicare Advantage insurer in the country, covering 8 million people older than 65 and people with disabilities, making this policy particularly important for older Americans on those private plans.

The FEHBlog expects UHC’s announcement to be the tip of the eventual iceberg of similar Aduhelm coverage decisions.

Following up on previous stories mentioned in the FEHBlog, the Wall Street Journal reports

Online pharmacy company Truepill Inc. said it is temporarily halting prescriptions for Adderall and other controlled substances used to treat attention-deficit hyperactivity disorder, and partner Cerebral Inc. told its clinicians to direct those orders to patients’ local pharmacies.

Cerebral, an online mental-health company based in San Francisco that describes Truepill as its preferred pharmacy, informed its clinicians of Truepill’s decision in a Friday email viewed by The Wall Street Journal. The email said Truepill would no longer support mailing Schedule 2 controlled substances, including Adderall and Vyvanse, “to any of their customers.”

Truepill said that, “out of an abundance of caution,” it is temporarily pausing all fulfillment of Schedule 2 substances while it evaluates appropriate next steps. It said Schedule 2 substances such as Adderall make up less than 1% of its total prescription volume. Truepill didn’t provide a list of other partners affected by its decision.

Some of the nation’s largest pharmacies have blocked or delayed prescriptions over the past year from clinicians working for telehealth startups that have sprung up to treat ADHD, according to pharmacies and people familiar with the issue.

The Journal reported last week that pharmacies including Walmart Inc., CVS Health Corp. and Walgreens Boots Alliance Inc. have blocked or delayed prescriptions for companies treating ADHD online or have blocked individual prescribers, according to people familiar with the issue.

That was the right outcome as far as the FEHBlog is concerned.

In U.S. Supreme Court news, Business Insurance reports “Private plaintiffs cannot be reimbursed for emotional distress damages under the 1973 Rehabilitation Act and the Patient Protection and Affordable Care Act, the U.S. Supreme Court ruled” last Thursday in the linked opinion. The Affordable Care Act provision at issue is the ACA’s convoluted individual non-discrimination provision, Section 1557.

From the healthcare business front, Fierce Healthcare tells us

Outpatient volumes and revenue for hospitals and health systems showed a robust rebound in March as expenses eased due to fewer extremely sick patients, a new report said. 

Consulting firm Kaufman Hall released its latest hospital flash report Monday (PDF) detailing the impact of system finances for the month of March. A key takeaway from the report is that while actual hospital margins were negative for the third month in a row, outpatient revenues had a massive bump.

“While the road to recovery remains long for many hospitals, these trends indicate some pressures of the pandemic may be lifting,” said Erik Swanson, senior vice president of data and analytics with Kaufman Hall, in a statement. 

From the mental healthcare front,

Fierce Healthcare reports

Mental health concerns are on the rise across the board, and especially among Blacks, seniors, young adults and LGBTQIA people, a new survey finds.

CVS Health and Morning Consult polled more than 2,200 adults in early April and found that 59% of respondents have experienced challenges with their mental health or that of a friend or family member. That is a 9% increase over 2020 survey data.

More than half (57%) of people surveyed who identify as LGBTQIA expressed concern about their own mental health, 20 percentage points higher than other groups included in the study. Nearly three-quarters (74%) of those aged 18 to 34 said they experienced such concerns either themselves or for a friend or family member, up 12 percentage points from 2020.

The survey also found an 11 percentage point increase in mental health concerns among Black respondents compared to pre-COVID levels. A double-digit increase was also found among people over age 65; about 40% reported mental health concerns for themselves or family and friends, up 10 percentage points from 2020.

AHIP describes ten ways that people can get the mental healthcare services that they need.

Weekend update

Happy Law Day 2022!

The House of Representatives and the Senate will be engaged in Committee business and floor voting this week.

From the Omicron and siblings front

The Wall Street Journal informs us

As new Omicron variants further infiltrate the U.S., a jumble of signals suggest the latest increase in Covid-19 infections hasn’t sparked a commensurate surge in severe illness even as risks remain.

Covid-19 virus levels detected in wastewater in the Northeast, the first region to see significant concentrations of the easily transmitted Omicron BA.2 variant, appear to have flattened out in the past two weeks. Covid-19 hospital admissions have risen in the region, but they remain far below levels during earlier surges that indicated widespread severe illness and taxed healthcare facilities. 

“This wave of Covid in the United States, in the places where it is, is not dangerous in a way that prior waves of Covid were,” said Megan Ranney, an emergency physician and academic dean at Brown University’s School of Public Health.

The fast-mutating virus still poses risks, she said. 

The new Fortune Well website offers timely guidance on the symptomatic differences between Covid and allergies.

Bloomberg Prognosis posted its late April Word Covid resilience rankings. Norway rides atop the rankings for the second month in a row The U.S. dropped six rankings to 30th. The article notes that the U.S. and the U.K are “weighed down by ongoing fatalities—their Covid Mortality Rate scores are among the worst of developed economies.

From the Affordable Care Act front, Health Affairs Forefront posted the ever-reliable Katie Keith’s first of three articles on the final 2023 ACA notice of benefit and payment parameters that was issued last week. This article’s section on Essential Health Benefits is relevant to FEHB carriers as each of them must select an EHB benchmark in order to apply the ACA’s restriction on annual dollar limits. The article’s section on Medical Loss Ratio is relevant to community-rated FEHB plans who generally use that benchmark to determine the reasonableness of their prices.

From the Rx coverage front, Medcity News reports “Bristol Myers Squibb drug Camzyos has received FDA approval for treating obstructive hypertrophic cardiomyopathy, a rare and potentially fatal heart disorder. The drug is projected to become a blockbuster seller, and its approval marks a payoff for BMS’s 2020 acquisition of the medicine’s developer, MyoKardia.”

From the telehealth front, mHealth Intelligence informs us

A majority of clinics (79 percent) used telemedicine to provide contraceptive services during the COVID-19 pandemic, according to a recent study published in the journal Reproductive Health.

For the study, researchers surveyed 907 US providers and clinic staff between April 10, 2020, and Jan. 29, 2021. They collected data on contraceptive service delivery challenges and strategies, including telehealth. The sample of respondents included physicians (17 percent), advanced practice clinicians (41 percent), registered nurses (16 percent), and health educators and social workers (11 percent).

The respondents practiced in a wide array of care settings, including youth clinics/school-based health centers or college health centers (36 percent), primary care clinics or health departments (29 percent), family planning clinics (22 percent), and independent abortion care clinics (4 percent). They saw, on average, 3,184 contraceptive patients annually.

Though only 11 percent of the clinics offered telemedicine for contraceptive services before the pandemic, this figure shot up to 79 percent after March 2020.

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’s weekly charts of new Covid cases and deaths from the 27th week of 2021 through the 17th week of 2022:

In addition, here’s the CDC’s Chart of Daily Trends in the Number of New COVID-19 Hospital Admissions in the United States:

Can you say endemic?

Below you will find the FEHBlog’s weekly chart of Covid vaccinations distributed and administered from the beginning of the Covid vaccination era in December 2020 to the current week 17.

The CDC’s Covid Data Tracker Weekly Review points out, “This week, the U.S. COVID-19 Vaccination Program marks two milestones: 500 days since the first COVID-19 vaccine was approved for use in the United States, and 100 million first booster doses administered.”

In the New York Times, David Leonhardt reports that the FDA is waiting to receive additional data from Pfizer and Modera [likely next month] to support their emergency use authorizations for Covid vaccines for children between six months and five years. Although the FDA’s preference is to give EUAs to both vaccines simultaneously to provide parents a choice, the agency will not delay a EUA decision on one or the other unnecessarily.

The CDC’s weekly review adds,

Currently, there are 54 (1.68%) counties, districts, or territories with a high COVID-19 Community Level, 256 (7.95%) counties with a medium Community Level, and 2,910 (90.37%) counties with a low Community Level. This represents a slight (0.59%) increase in the number of high-level counties, a small (+1.43%) increase in the number of medium-level counties, and a corresponding (−2.02%) decrease in the number of low-level counties. Seventeen (30.36%) of 56 jurisdictions had no high- or medium-level counties this week.

To check your COVID-19 community level, visit COVID Data Tracker.

From the health savings account front, the Society for Human Resource Management reports

Health savings account (HSA) contribution limits for 2023 are going up significantly in response to the recent inflation surge, the IRS announced April 29, giving employers that sponsor high-deductible health plans (HDHPs) plenty of time to prepare for open enrollment season later this year.

The annual inflation-adjusted limit on HSA contributions for self-only coverage will be $3,850, up from $3,650 in 2022. The HSA contribution limit for family coverage will be $7,750, up from $7,300. The adjustments represent approximately a 5.5 percent increase over 2022 contribution limits, whereas these limits rose by about 1.4 percent between 2021 and 2022.

In Revenue Procedure 2022-24, the IRS confirmed HSA contribution limits effective for calendar year 2023, along with minimum deductible and maximum out-of-pocket expenses for the HDHPs with which HSAs are paired.

Here is that 2023 deductible and OOP max information:

For calendar year 2023, a “high deductible health plan” is defined under § 223(c)(2)(A) as a health plan with an annual deductible that is not less than $1,500 for self-only coverage or $3,000 for family coverage [Self-only: +$100 Family: +200 from 2022], and for which the annual out-of-pocket expenses (deductibles, co-payments, and other amounts, but not premiums) do not exceed $7,500 for self-only coverage or $15,000 for family coverage [Self-only: +$450 Family: +$900 from 2022].

From the Medicare Part D front, Fierce Healthcare reports

CMS is giving Part D plans a little extra time to prepare to funnel price concessions to the member at the point of sale.

The Centers for Medicare & Medicaid Services on Friday finalized a rule with the price concession changes as well as a slew of updates for Medicare Advantage plans.

The agency said in a fact sheet on the regulation that beginning Jan. 1, 2024, it will define the negotiated price for a drug in Part D as the baseline, or lowest possible, payment to a pharmacy to ensure that price concessions are felt at the point of sale by beneficiaries.

“This policy reduces beneficiary out-of-pocket costs and improves price transparency and market competition in the Part D program,” CMS said.

The bell for prescription drug rebates is beginning to toll.

From the healthcare business front, Healthcare Dive tells us

Molina Healthcare in the first quarter recorded its highest COVID-19 costs since the start of the pandemic, CEO Joe Zubretsky said Thursday.

However, those costs were almost entirely offset by members cutting back on healthcare visits, a common trend throughout the pandemic, he said on a call with investors.

After costs peaked in January, they quickly declined in the subsequent months. “When I say [COVID-19 costs] subsided during the quarter, it did so dramatically,” Zubretsky added.   

HR Morning discusses a recent Willis Towers Watson survey on how employers are dealing with rising health care costs. To make healthcare more affordable for employees.

Fifty-five percent said their plan is to improve quality and outcomes to lower overall cost. Adding or enhancing low- or no-cost coverage for specific benefits is the plan for 41%. And 32% will be making changes to employees’ out-of-pocket costs, while 21% said they’ll alter their health plan payroll contributions.

From the preventive services front, the U.S. Preventive Services Task Force made a final grade D recommendation against initiating low-dose aspirin use for the primary prevention of CVD in adults 60 years or older. “For adults aged 40 to 59 years with an estimated 10% or greater 10-year cardiovascular disease (CVD) risk:  The decision to initiate low-dose aspirin use for the primary prevention of CVD in this group should be an individual one.” This is a Grade C recommendation.

Thursday Miscellany

Photo by Josh Mills on Unsplash

From the Omicron and siblings front —

MedPage Today brings us up to date on the whereabouts of Omicron BA 2.12.1.

“What we’re seeing right now is a version of the virus that is much more transmissible than previous versions of the virus, perhaps, but also less likely to cause severe disease,” Perry Halkitis, PhD, MPH, dean of the Rutgers School of Public Health, told MedPage Today.

The FEHBlog heard a fascinating talk about the Long Covid or PASC on the second and final day of the 2022 OPM AHIP Carrier Conference. Dr. Micheal Brode explained that PASC usually is evidenced by fatigue, brain fog, or exertional fatigue more than 12 weeks after the first symptoms of Covid. People afflicted by PASC typically, but not always, were hospitalized when Covid was in its acute opening phase. Covid vaccinations reduce the risk of contracting PASC by at least 50%, but they don’t prevent PASC. Although it’s premature for evidenced-based treatment guidelines to exist, Dr. Brode complimented the work of the PASC Collaborative to get to that point expeditiously. Most PASC patients recover slowly with medical care, although some PASC patients have permanent disabilities. Dr. Brode reminded the audience that Covid is a multi-system disease, not only a lung disease. PASC’s recently added ICD-10 code is U09.9.

The American Hospital Association adds, “Moderna today asked the Food and Drug Administration to authorize for emergency use its COVID-19 vaccine in children aged six months through 5 years, citing previously released data estimating the vaccine’s efficacy against the omicron variant in this age group was similar to that in adults, with a favorable safety profile.”

From the Affordable Care Act front, the ACA regulators released the final 2023 notice of benefit and payment parameters and the Final 2023 Actuarial Value Calculator and Methodology. Fierce Healthcare highlights the significant changes facing ACA qualified health plans in 2023.

From the healthcare business front —

Humana has released its 1st Quarter 2022 earnings. Fierce Healthcare provides background on the favorable report.

Fierce Healthcare informs us, “Walmart’s telehealth provider, MeMD, is rolling out the virtual diabetes program as a standalone service or as part of a comprehensive medical and behavioral telehealth program for enterprise customers and health plans. The retail giant collaborated with the American Diabetes Association on the virtual program, which was developed to help employees and members close gaps in diabetes management through early intervention, Walmart Health executives said.”

From the drug research front, BioPharma Dive tells us

Eli Lilly’s experimental diabetes shot tirzepatide helped obese people who have an underlying medical condition lose more than 15% of their body weight in a late-stage clinical trial. At the highest dose tested, patients receiving the weekly injection lost, on average, 21% of their body weight, Lilly said in a press release Thursday.

The data suggests tirzepatide could challenge similar drugs marketed by Danish drugmaker Novo Nordisk, which earned about $1.2 billion when prescribed for obesity in 2021. Novo’s weekly weight-loss shot Wegovy helped patients with medical complications lose an average of 15% of their body weight in clinical testing.

Wall Street analysts forecast swift growth for obesity drugs in coming years as patients, doctors and insurers acknowledge the effectiveness of newer agents like Wegovy and tirzepatide. Wegovy sales alone are expected to reach $5.5 billion in 2026, according to consensus estimates highlighted by Cantor Fitzgerald analyst Louise Chen in January.

From the federal employment front —

The U.S. Office of Personnel Management (OPM) released government-wide results of the 2021 OPM Federal Employee Viewpoint Survey (OPM FEVS). Federal News Network summarizes the results as follows:

Change is the biggest constant for the federal workforce after two years in a pandemic that capsized government operations. Despite the upheaval, employee engagement remained relatively steady over the last year, dropping just one point between 2020 and 2021, from 72% down to 71%.

But other factors, like employees’ job and pay satisfaction, declined in 2021 compared to 2020. The overall index points for global satisfaction dropped as well, from 69% down to 64%.

Govexec notes

As part of his fiscal 2023 budget proposal, [President] Biden proposed an average pay increase of 4.6% for civilian federal workers and members of the military, which, if implemented, would mark the biggest raise the federal workforce has seen in 20 years. Although it is unclear how that raise would be broken up between across-the-board increases to basic pay and an average boost to locality pay, traditionally, 0.5% of the pay raise has been set aside for locality pay increases.

In a letter, [62] House Democrats led by Rep. Gerry Connolly, D-Va., pressed the leadership of the House Appropriations Committee to go further than the president and endorse a 5.1% average pay increase for feds, reflecting legislation introduced by Connolly and Sen. Brian Schatz, D-Hawaii, that would grant federal employees a 4.1% across-the-board boost to basic pay and a 1.0% average increase in locality pay.

And don’t forget that this Saturday, April 30, is National Prescription Drug Take-Back Day.

Midweek update

Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

Today, the FEHBlog attended day one of the virtual OPM AHIP FEHB Carrier Conference. OPM informed carriers to expect a carrier letter on the No Surprises Act. OPM also presented panels delving into Biden administration initiatives described in the 2023 call letter. The second and final day is tomorrow.

The FEHBlog suggests that OPM resume the practice of including health plan and PBM representatives on its conference panels to provide more relevant perspectives on these initiatives.

From the Omicron front, the Wall Street Journal informs us

There’s a good chance you’ll get Covid more than once.

Covid-19 reinfections are more common and can happen within a shorter window of time than doctors previously thought possible, recent research suggests. More than half of people in the U.S. showed signs of having been infected at least once as of February, according to a report Tuesday from the Centers for Disease Control and Prevention. * * *

“On average at a population level, the people who get reinfected have milder symptoms,” says Francois Balloux, an infectious disease epidemiologist and director of the UCL Genetics Institute in London. “That doesn’t mean that some people might not have a worse infection the second or even third time.” 

From the SDOH front, Health Payer Intelligence tells us

The Blue Cross and Blue Shield Association (BCBSA) and the Blue Cross and Blue Shield companies have urged the healthcare industry to adopt national health equity data collection standards.

The companies released a paper that defines health equity and submits a proposed model for data collection standardization.

That is a valuable resource.

From the telehealth front, Healthcare Dive reports

Whether or not telehealth visits result in duplicative care — a hot topic on the Hill as Congress debates future telemedicine regulation — could depend on whether users have acute or chronic conditions, a new study suggests.

Researchers analyzed data from almost 41 million commercially insured adults, and found patients with acute conditions that had an initial telehealth visit were slightly more likely to have a follow-up encounter, emergency room visit or inpatient admission, compared to those who had an in-person visit.

However, patients with chronic conditions that had an initial telehealth visit were as or less likely to need follow-up care, than those with an initial in-person visit.

That’s practical information for you.

Healthcare Dive adds

Teladoc Health recorded a $6.6 billion impairment charge in the first quarter, reflecting the waning market value of its acquisition of chronic care company Livongo inked two years ago.

Teladoc, the largest virtual care company in the U.S., bought Livongo for $18.5 billion in cash and stock late 2020 in the biggest digital health deal to date. However, the merger has struggled, resulting in the large goodwill impairment charge for the Purchase, New York-based vendor.

The charge drove Teladoc’s net loss up to $6.7 billion in the quarter, a record for the company. That’s more than 33 times bigger than its loss of about $200 million during the same time last year; and about 16 times its full year 2021 net loss of $429 million.

Ouch.

The Wall Street Journal reports

Some of the nation’s largest pharmacies have blocked or delayed prescriptions over the last year from clinicians working for telehealth startups that have sprung up to treat attention-deficit hyperactivity disorder, according to pharmacies and people familiar with the issue.

The pharmacies in certain cases have expressed concerns that clinicians at Done Health and Cerebral Inc. are writing too many prescriptions for Adderall and other stimulants, the people said. The federal government considers the drugs controlled substances because of their potential for abuse and places them in the same category as cocaine.

From the mental health and substance use disorder front —

Fierce Healthcare calls attention to the fact

Mental and behavioral health conditions account for a growing segment of healthcare costs, and insurers have a significant opportunity to address these expenses and drive costs down overall, according to a new report [which is behind a Moody’s paywall].

Mental health conditions accounted for just 5.2% of healthcare spending in 2019, but the number of people with these conditions is expanding, particularly in the pandemic environment, according to a report from analysts at Moody’s Investors Service.

A recent study suggests that healthcare costs for people with behavioral health conditions are 3.5 times higher than for those without such conditions, according to the report. Annual healthcare costs for patients with behavioral health needs are $12,272, with just 7.9% of that specifically for the behavioral conditions.

The National Institutes of Health offers a Q&A with Dr. Rena D’Souza, the Director of the National Institute of Dental and Craniofacial Research.

RB: Thanks for joining me, Rena. Many people might not recognize the relevance of oral health in opioid use and pain. Can you give us some examples of NIDCR HEAL projects and recent findings?

RD: Rebecca, thanks for the opportunity to have this conversation. Managing and treating dental, oral, and craniofacial pain is central to NIDCR’s vision to improve oral health and well-being for all people. So there’s an obvious connection. NIDCR HEAL projects include research to discover new, non-addictive ways to prevent and treat orofacial pain disorders such as temporomandibular disordersinflammatory and neuropathic pain, and oral cancer-associated pain. NIDCR HEAL researchers are also in the early stages of developing a material that can seal surgical wounds and deliver pain medicine on-site to help reduce the need for opioids after oral surgery. In addition, our institute is interested in how socioeconomic status, race, ethnicity, and other social determinants of health play a role in chronic pain, pain management, and patient outcomes.

This work is necessary to tackle our opioid epidemic.

The Department of Health and Human Services announced the availability of “new, free informational resources that inform Americans of their rights under law on coverage for mental health benefits.”

“The following resources have been posted on SAMHSA’s website:

  1. Know Your Rights: Parity for Mental Health and Substance Use Disorder Benefits,” an updated trifold pamphlet explaining mental health parity, detailing what it means to the consumer, and listing the protections the parity law provides.
  2. Understanding Parity: A Guide to Resources for Families and Caregivers,” which provides an overview of parity geared toward parents, family members or caregivers with information and tools to help them obtain behavioral health services for children or family members in their care.
  3. The Essential Aspects of Parity: A Training Tool for Policymakers,” which provides state regulators and behavioral health staff an overview of mental health and substance use disorder parity and how to implement and comply with the federal parity law regarding employer-sponsored health plans and group and individual health insurance.”

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From the Omicron and siblings front —

The American Hospital Association informs us

The share of the U.S. population with antibodies to the SARS-CoV-2 virus in their bloodstream increased from 34% in December 2021 to 58% in February 2022, including 75% of children, according to a study released today by the Centers for Disease Control and Prevention. The study tested blood samples during the COVID-19 omicron period for antibodies produced in response to infection but not in response to COVID-19 vaccines. Children had the highest rates of infection-induced antibodies and adults 65 and older the lowest, with the greatest increases over the period in age groups with the lowest COVID-19 vaccination coverage. 

“Vaccination remains the safest strategy for preventing complications from SARS-CoV-2 infection, including hospitalization among children and adults,” the authors said. 

and

Starting this week, the Administration will allow all pharmacies in the federal pharmacy program to order free oral antiviral treatments directly from the federal government, the White House announced today. The Administration hopes to double the number of participating pharmacies to 40,000 in the coming weeks, and to launch new Test-to-Treat locations that offer the Pfizer and Merck pills, which the Food and Drug Administration authorized in December to treat COVID-19 in patients at risk of progressing to severe disease. Pharmacies also can continue to receive the pills through their state or territorial health department. The Administration said it is working to improve the Test-to-Treat patient experience, including through telehealth options; and to provide more guidance on COVID-19 treatments to prescribers and clinicians.

The New York Times adds more details to this AHA blurb. In short, “experts say that efforts to reach at-risk Americans remain complex and inefficient.”

Medscape adds “Contrary to popular belief, no association appeared between the number of intensive care unit beds and COVID-19 deaths, based on a review of data from all 50 states between March 1, 2020, and June 30, 2021.”

The Wall Street Journal further reports

Pfizer Inc. and partner BioNTech SE asked U.S. health regulators to authorize a booster dose of its Covid-19 vaccine for children 5 to 11 years old.

The request Tuesday to the Food and Drug Administration comes after the companies said earlier this month that a third shot safely generated a strong immune response in the youngsters, including significantly increased antibody levels against the Omicron variant. 

A thumbs-up from the FDA would expand eligibility of boosters to the roughly 28 million children in the U.S. Booster doses are now available for people as young as 12 years old in the U.S., and regulators recently greenlighted second boosters for people who are 50 years old and up or who have weakened immune systems

In FEHB news, OPM issued a paper describing the 2021 highlights of OPM’s FEHB Plan Performance Assessment system. In the FEHBlog’s view, OPM’s PPA system could be improved by (1) seeking plan input on all PPA changes, including, for example, the benchmark change to ALOB and (2) implementing changes for the first measurement year following the change, not the year in which the change is made. Both of these changes are consistent with federal administrative law, in the FEHBlog’s opinion. Also, OPM should use the carrot incentive more than the stick.

In healthcare business news,

Healthcare Dive tells us

Hospitals are experiencing a “massive surge” in expenses for items such as labor, drugs and supplies amid rising inflation, the American Hospital Association said in a report on Monday.

Labor is a particular stressor, making up more than half of hospitals’ total expenses. Overall, hospital labor expenses per patient increased almost 20% from 2019 to 2021, the AHA said. 

The powerful hospital lobby urged Congress to help address these headwinds by adding money to the provider relief fund and creating flexibility on advanced Medicare repayments, among other items.

Medpage Today informs us

Nearly three-fourths of U.S. physicians opted for employment with hospitals, health systems, or other corporate entities, such as private equity firms and health insurers in the pandemic era, according to a new report.

In 2021, 73.9% of physicians were hospital- or corporate-employed, up from 69.3% at the start of 2021, 64.5% at the start of 2020, and 62.2% at the start of 2019, according to the nonprofit Physicians Advocacy Institute (PAI) and consulting firm Avalere. That equates to 484,100 employed physicians, up from 423,800, 391,000, and 375,400 at the start of 2021, 2020, and 2019, respectively.

Perhaps these two trends are related? On the one hand, more physician employees create more hospital expenses. On the other, a hospital receives additional health plan payments for services provided by physician employees. In all likelihood, the revenue exceeds the expense in this case.

From tidbits department,

  • AHRQ reports on “Geographic Variation in Inpatient Stays for Five Leading Mental Disorders, 2016–2018.”

CAQH CORE, the author of national operating rules for the HIPAA-covered administrative transactions, recently released new operating rules to enhance information exchange and healthcare operations related to benefits coverage and supplemental documentation. * * *

The new CAQH CORE Attachments Operating Rule aims to improve the exchange of attachments, a long-standing industry issue. The guidelines will establish key infrastructure and data content requirements, helping providers send electronic health plans documentation to support a claim or prior authorization in a uniform format, the press release stated.

Reassociation or linking the attachment with the original prior authorization request or claim submission is one of the most significant pain points in the attachment workflow, CAQH CORE added.

The new guidelines also offer updates to enhance the exchange of critical eligibility and benefit information related to telemedicine, prior authorization, remaining coverage benefits, procedure-level information, and tiered benefits between health plans and providers.

The second newly released rule, the CAQH CORE Eligibility & Benefits Data Content Rule, intends to enhance provider knowledge regarding their patients’ coverage, leading to more timely care and accurate billing.

Finally, CAQH CORE revised its rules for infrastructure, which now calls for greater health plan system availability and less frequent periods of downtime.

  • Health Payer Intelligence notes “Applying an out-of-pocket spending cap to Medicare Part D could be a tool for promoting health equity, according to an insight from Avalere.”

Monday Roundup

Photo by Sven Read on Unsplash

From the No Surprises Act front, the FEHBlog nearly fell off his chair when he noticed this Healthcare Dive article:

The Department of Justice intends to appeal a federal judge’s ruling that sided with providers over a challenge to the surprise billing rule, according to a Friday filing from the DOJ in the Eastern District of Texas.  

The Texas Medical Association sued the federal government over its interpretation of the No Surprises Act, arguing the rule leans too heavily on one factor arbiters are supposed to consider when resolving payment disputes between payers and providers.      

Federal Judge Jeremy Kernodle’s February ruling said nothing in the bill passed by Congress instructs arbiters to “weigh any one factor … more heavily than the others,” indicating the rule conflicts with the bill.

The Justice Department noticed an appeal to the Fifth Circuit in the referenced Friday, April 22, filing with the District Court. That notice effectuates the appeal. The FEHBlog will keep an eye on the dockets to learn whether the Justice Department will seek a stay of the February ruling while the case is on appeal.

From the Omicron and siblings front —

  • Bloomberg’s Prognosis reviews progress being made in the development of Covid vaccines administered nasally. Nasal vaccines have a better shot at preventing COVID than injected vaccines.
  • The American Hospital Association reports “The Food and Drug Administration today expanded its approval for remdesivir (Veklury) to include pediatric patients under age 12 who test positive for SARS-CoV-2 and are hospitalized or at high risk of progressing to severe COVID-19. The patient must be at least 28 days old and weigh at least 3 kilograms (about 7 pounds). FDA said the approval is supported by a clinical study of 53 pediatric patients as well as trials in adults, given the similar course of disease in adult and pediatric patients.”
  • Medical Dialogues informs us the World Health Organization has recommended Pfizer’s Paxlovid Covid pill over remdesvir, Merck’s pill and monoclonal antibodies for patients with milder forms of Covid and nevertheless at high risk of hospitalization from the disease, e.g. the elderly, the immunocompromised, and the unvaccinated.
  • WebMD News tells us “COVID-19 was the third-leading cause of death in the United States in 2021 for the second straight year, with only heart disease and cancer causing more deaths, the CDC said Friday. * * * The overall number of COVID deaths in 2021 increased around 20% over 2020, when around 384,000 people died from the virus, the CDC said. COVID deaths in 2021 peaked for the weeks ending Jan. 16 and Sept. 11, following holiday periods.”

The WebMD article offers other interesting public health nuggets. For example,

About 693,000 people died of heart disease in 2021, with 605,000 dying of cancer and 415,000 of COVID, the CDC said, citing provisional data that might be updated later.

Unintentional injuries were the fourth-leading cause of death, increasing to 219,000 in 2021 from 201,000 in 2020. Influenza and pneumonia dropped out of the top 10 leading causes of death and suicide moved into 10th place.

Overall, about 3,458,697 deaths were reported in the U.S. last year. The age-adjusted death rate was 841.6 deaths per 100,000 people, an increase of .7% from 2020. The 2021 death rate was the highest since 2003, the CDC said.

From the healthcare business front, Fierce Healthcare reports

Change Healthcare has found a buyer for its payment integrity arm, ClaimsXten, though the sale is contingent on the closure of its merger with UnitedHealth Group.

According to a filing submitted Monday to the Securities and Exchange Commission, ClaimsXten will be sold off to an affiliate of TPG Capital for a base purchase price equal to $2.2 billion in cash. UnitedHealth is listed as the seller.

From the reports department —

  • The National Bureau of Economic Research offers a working paper titled “Pharmacy Benefit Managers and Vertical Relationships in Drug Supply: State of Current Research.”
  • Per HR Morning, “Employer support [of their workforces] is happening in the areas of increased prioritizing employee assistance programs (EAPs), expanded wellness benefits and greater attention to work/life balance. That’s according to Ragan’s 2022 Communications Benchmark Report that surveyed close to 1,000 communicators across industries on opportunities and changes.”
  • Per Health Payer Intelligence, Humana has produced an issue brief that provides “an overview of the policymaking landscape surrounding social determinants of health data collection.”