Tuesday’s Tidbits

Rx coverage

Tuesday’s Tidbits

David Ermer–CDC, COVID-19, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on UnsplashFr

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

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

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

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

The Journal adds

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

AHIP informs us

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

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

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

BioPharma Dive tells us

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

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

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

From the Rx coverage front, the Federal Trade Commission announced

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

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

** fees and clawbacks charged to unaffiliated pharmacies;

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

** potentially unfair audits of independent pharmacies;

** complicated and opaque methods to determine pharmacy reimbursement;

the prevalence of prior authorizations and other administrative restrictions;

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

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

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

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

From the miscellany department

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

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

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

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

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

Monday Roundup

David Ermer–Congress, COVID vaccine mandate, COVID-19, Federal employment benefits, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Capitol Hill, Medpage Today suggests that prior authorization practices are under Congress’s spotlight.

From the Omicron and siblings front–

  • The Wall Street Journal offers an interesting report on the ups and downs of Omicron and its siblings.
  • Govexec tells us about recent Safer Federal Workforce changes to “its COVID-19 protocols to draw more distinctions between the policies for vaccinated and unvaccinated workers, including those related to travel and paid leave.”

From the federal employment front, the Society for Human Resource Management explains how the federal government is “struggling mightily to recruit, retain and develop the talent it needs to succeed and earn the reputation of being a “model employer.” Agencies and their HR leaders are working to upgrade antiquated systems and processes. The new-hire process currently takes an average of 100 days to complete, double that of the private sector.” Good luck.

From the Rx coverage front, Prime Therapeutics announced last week

Leading pharmacy benefit manager (PBM) Prime Therapeutics LLC (Prime) analyzed its real-world data to assess clinical outcomes and drug waste differences between medically integrated dispensing (MID) and central specialty pharmacy dispensing of oral cancer therapies. This study of a Prime pilot program showed a potential average savings opportunity of $1,800 per medication dose change at a MID pharmacy compared to a central fill specialty pharmacy. Results reinforced Prime’s position of the advantages of the MID model, on which its IntegratedRx™ program is based.

With the MID model, care providers – including doctors and pharmacists – have access to prescribing history, test results and other important patient information in the EMR. This coordination informs the care team earlier than the traditional model. This early look has potential to help lower the number of 30-day prescriptions going to waste.

Prime’s MID pilot program was implemented in early 2021 within three oncology practices and across three Blue Plans’ commercially insured lives to prove the potential care and cost advantages with this distinct model compared to a centralized specialty pharmacy model. Study participants were prescribed oral drugs that did not require dispensing and shipment from a payer-directed specialty pharmacy to the oncologist (aka white bagging).

From the studies department —

  • Health Payer Intelligence informs us “More consumers reported that their health plans are offering transparency tools and overall consumer awareness about the availability of transparency tools has grown, according to a study conducted on behalf of HealthSparq.”
  • MedPage Today discusses a study finding that weight loss, even when achieved by bariatric surgery, will reduce the risk of obesity-related cancer. The FEHBlog wonders if weight loss produced by the current, effective weight loss drugs would have a similar health impact.
  • mHealth Intelligence notes that “To reduce the amount of time spent in a virtual waiting room, researchers from the University of California San Diego conducted a pilot that used text messaging to provide patients with a meeting link when their provider was ready to see them, finding it to be a successful alternative.”
  • The New York Times reports on a GlaxoSmithKline “checkpoint inhibitor” drug trial conducted on eighteen rectal cancer patients. The drug wiped out the cancer in all of those patients. Quite amazing. According to the Times experts indicate that the trial needs to be replicated.
  • BioPharma Dive reports “Twenty-four years ago, a drug called Herceptin changed how doctors treat breast cancer. Its approval in 1998 made it possible to target the aggressive breast tumors tied to a gene called HER2. Other drugs quickly followed Herceptin and, over the years since, have substantially improved survival for people with the disease. A quarter of a century later, another shift in treatment could be on the horizon. At the American Society of Clinical Oncology meeting, AstraZeneca and Daiichi Sankyo are presenting results proving that, for the first time, a targeted medicine can help metastatic breast cancer patients whose tumors express only low levels of HER2. Clinical trial data revealed at ASCO and published in The New England Journal of Medicine Sunday show the drug, Enhertu, halved the risk of cancer progression compared to chemotherapy and reduced the risk of death by 36%.”
  • The Guardian tells us “Taller people have an increased risk of peripheral neuropathy, as well as skin and bone infections, but a lower risk of heart disease, high blood pressure and high cholesterol, according to the world’s largest study of height and disease. A person’s height raises and reduces their risk of a variety of diseases, according to the research led by Sridharan Raghavan of the Rocky Mountain Regional VA Medical Center in the US. The findings are published in the journal PLOS Genetics.”

From the potpourri department, check out this NIH Newsletter for June 2022.

Thursday Miscellany

David Ermer–COVID-19, Federal employment benefits, Medicare, Rx coverage, Telehealth–

From Washington, D.C., and “Following a meeting of the Social Security and Medicare Boards of Trustees, the U.S. Department of the Treasury—joined by Departments of Health and Human Services and Labor, the Centers for Medicare & Medicaid Services, and the Social Security Administration—released the annual Social Security and Medicare Trustees Reports.” Here is a link to the government’s fact sheet on those reports.

The American Hospital Association explains

The Medicare Hospital Insurance Trust Fund will have sufficient funds to pay full benefits until 2028, according to the latest annual report released today by the Medicare Board of Trustees.

That’s two years later than last year’s report. The HI Fund, known as Medicare Part A, helps pay for inpatient hospital services, hospice care, and skilled nursing facility and home health services following hospital stays.

HI income is projected to be higher than last year’s estimates because both the number of covered workers and average wages are projected to be higher, according to the report. In addition, HI expenditures are projected to be lower than last year’s estimates in the beginning of the short-range period mainly due to the pandemic but are projected to become larger after 2023 due to higher projected provider payment updates.

“There is substantial uncertainty in the economic, demographic, and health care projection factors for HI trust fund expenditures and revenues,” the report notes. “Accordingly, the date of HI trust fund depletion could differ substantially in either direction from the 2028 intermediate estimate.”

From the Omicron and siblings front

Bloomberg Prognosis reports

More than two-thirds of the world’s population probably have significant levels of Covid-19 antibodies, meaning they have either been infected or were vaccinated, the World Health Organization said. 

So-called seroprevalence rates surged to 67% in October from 16% in February of 2021, the WHO said, in a summary of studies from around the globe. Given the emergence of the fast-spreading omicron variant, the figure is probably even higher now.

The National Institutes of Health (NIH) announced

A large randomized, placebo-controlled clinical trial led by the National Institutes of Health shows that treating adults hospitalized with COVID-19 with infliximab or abatacept – drugs widely used to treat certain autoimmune diseases – did not significantly shorten time to recovery but did substantially improve clinical status and reduce deaths.

That’s a good trade-off.

From the federal employee benefits front

  • OPM released a proposed Federal Long Term Care Insurance Program rule today. The rule indicates that OPM is planning a suspension of enrollments in this Program. “For example, it may be appropriate to suspend applications to allow a period of time for revisions to underwriting processes or for premium repricing after a review of actuarial assumptions, in order to ensure that premium rates reasonably and equitably reflect the cost of the benefits provided as required by the statute and to ensure that OPM can provide eligible individuals with the information needed to enable them to fully evaluate the advantages and disadvantages of obtaining LTCI under FLTCIP.” (pp. 4-5). The public comment deadline is expected to be July 2, 2022.
  • Benefits consultant Tammy Flanagan responds in Govexec to reader questions about “about choosing when to retire in order to maximize the impact of both the annual cost-of-living adjustment to retirement benefits and the yearly federal employee pay increase.” Check it out.

From the transparency front

Roll Call discusses the progress of the hospital industry in achieving compliance with the federal government’s pricing transparency rule which became enforceable eighteen months ago.

While most hospitals have been willing to follow parts of the rule — namely, a requirement that they post user-friendly lists or tools to help patients shop for services — they have been less compliant with a requirement that they post “machine readable” files of standard charges — data that experts say would be far more useful in driving down costs.

That’s an intriguing factoid because the federal government’s health plan transparency rule’s similar requirement to post three “machine readable” files of claim payments data becomes enforceable on July 1, 2022.

From the Rx coverage front, Healthcare Dive informs us

* Rite Aid is the latest pharmacy giant to step into clinical care delivery through a new partnership with rural home care startup Homeward.

* Under the deal announced Tuesday, Rite Aid pharmacists will direct eligible customers to Homeward’s clinical services, including annual wellness visits, health screenings, diagnostic testing, virtual visits and in-home care. Homeward will also be able to park its mobile clinician units at Rite Aid’s rural locations, with the goal of allowing senior customers to see a provider and pick up their prescriptions in one visit.

* Homeward will provide in-network services, including specialty care beginning with cardiology, in the third quarter this year for patients covered by Medicare and Medicare Advantage plans. The companies are starting the partnership in Michigan, with the opportunity to expand to Rite Aid’s 700 rural locations across the U.S. over time.

From the telehealth front, Healio tells us

Telemedicine could be as effective as in-person medicine in evaluating pediatric genetic disorders, according to a study published in Pediatrics.

The study is the latest in a string of investigations examining clinicians’ and patients’ experiences in telemedicine following its widespread implementation during the COVID-19 pandemic. Evidence has suggested that telemedicine could significantly reduce costs for certain patients, but also that patients and practitioners may prefer in-person visits.

Midweek update

David Ermer–Congress, COVID-19, Rx coverage, U.S. Healthcare–

From Capitol Hill, A bipartisan PBM transparency bill was introduced by Senators Maria Cantwell (D Wash) and Charles Grassley (R Iowa) last week.

Sens. Chuck Grassley (R-Iowa), ranking member of the Judiciary Committee, and Maria Cantwell (D-Wash.), chair of the Committee on Commerce, Science and Transportation, have introduced legislation that would empower the Federal Trade Commission (FTC) to increase drug pricing transparency and hold pharmacy benefit managers (PBMs) accountable for unfair and deceptive practices that drive up the costs of prescription drugs at the expense of consumers.

The Pharmacy Benefit Manager Transparency Act of 2022 would ban deceptive unfair pricing schemes; prohibit arbitrary claw backs of payments made to pharmacies; and require PBMs to report to the FTC how much money they make through spread pricing and pharmacy fees.

Healthcare Dive reports on a recent study supporting the goals of this bill.

From the Omicron and siblings front

Bloomberg Prognosis informs us

Turns out a third dose of messenger RNA vaccine provides a key boost to immunity against Covid regardless of the original shot.

That’s what scientists from the Chinese University of Hong Kong found after scouring 53 studies that contained at least 24 different vaccine regimens. 

Three mRNA doses offered the best protection against infection, the researchers found, though just one of those shots as a booster after other types of Covid-19 vaccines worked almost as well. 

The Wall Street Journal tells us

Pfizer Inc. and partner BioNTech SE asked U.S. health regulators to authorize three doses of their vaccine for children under 5 years.

The request Wednesday to the Food and Drug Administration comes after the companies said last month that three doses of the shot were 80% effective at preventing symptomatic Covid-19 and generated a robust immune response in children ages 6 months to 5 years old.

The Pfizer-BioNTech vaccine was also found to be safe and well-tolerated among the children in studies, according to the companies.

FDA clearance could come before the end of the month. If the Centers for Disease Control and Prevention signs off, the last remaining group of people in the U.S.—roughly 19 million young children—would get access to shots at doctors’ offices, pharmacies and other locations.

The FDA is scheduled to consider the Pfizer and Moderna emergency authorization requests for mRNA Covid vaccinations for children aged six months to five years.

The National Institutes of Health reveals

A National Institutes of Health-funded study has found that people with food allergies are less likely to become infected with SARS-CoV-2, the virus that causes COVID-19, than people without them. In addition, while previous research identified obesity as a risk factor for severe COVID-19, the new study has identified obesity and high body mass index (BMI) as associated with increased risk for SARS-CoV-2 infection. In contrast, the study determined that asthma does not increase risk for SARS-CoV-2 infection.

The Human Epidemiology and Response to SARS-CoV-2 (HEROS) study also found that children ages 12 years or younger are just as likely to become infected with the virus as teenagers and adults, but 75% of infections in children are asymptomatic. In addition, the study confirmed that SARS-CoV-2 transmission within households with children is high. These findings were published today in the Journal of Allergy and Clinical Immunology.

From the healthcare business front

Fierce Healthcare reports

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

Sources told the news outlet that the purchase from Webster Equity Partners would earn HCAT a $300 million enterprise value and earnings before interest, taxes, depreciation and amortization in the high teens. UnitedHealth Group, Optum’s parent company, has made overtures to purchase HCAT in the past, according to the report.

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

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

N.B. The FEHBlog is in Dallas today!

Fierce Biotech tells us

GSK is betting big to reenergize its fight for a share of the pneumococcal vaccine market, agreeing to pay $2.1 billion upfront to acquire Affinivax for a challenger to Pfizer’s blockbuster Prevnar franchise.

The British Big Pharma already has an approved pneumococcal vaccine, Synflorix, but has failed to turn it into a true rival to Pfizer’s incumbent. Sales of Synflorix fell (PDF) to 357 million pounds sterling ($450 million) last year, while the Prevnar range of vaccines still topped (PDF) $5 billion in the face of COVID-related headwinds and the timing of government purchases. Last year’s approval of Merck & Co.’s Vaxneuvance further intensified competition. 

From the studies department

  • Forbes informs us “The U.S. spends twice as much on cancer care than average for high-income countries but mortality rates are only slightly better than average for these countries, according to a new study.”
  • Fierce Healthcare reports on a Kaiser Family News projection of 2022 insurer rebates required by the Affordable Care Act.

Kaiser’s analysis—which is based on data reported by insurers to state regulators—predicts that individual market insurers will have to pay out $603 million in rebates for 2022, with small group markets sending out $275.5 million and $168.1 million for large group plans. The final rates will be released later this year.

The $603 million for individual market plans, which includes the ACA’s exchanges, is far below the $1.3 billion in rebates for 2021 and $1.7 billion for 2020. 

Midweek Update

David Ermer–COVID-19, NIH, OPM, Rx coverage, U.S. Healthcare–

From the Omicron and siblings front —

Health Day informs us

COVID-19 might be easing into a new status as a widely circulating and somewhat harsher version of the common cold, experts say — a virus that folks could contract repeatedly, even if they were recently infected.

“[SARS-CoV-2] is destined to join four of its family members and become an endemic coronavirus that will repeatedly infect individuals throughout their lifetimes,” said Dr. Amesh Adalja, of Johns Hopkins Center for Health Security, referring to the four circulating coronaviruses that cause the common cold.

“It will become one of several respiratory viruses that people contend with, and will become increasingly less disruptive and more manageable with medical countermeasures and the population’s risk acclimatization,” he added.

The FEHBlog recently has pointed out unusual disease cases involving childhood hepatitis , monkeypox, a flu spike, etc. STAT News seeks to put these unusual cases in perspective.

These viruses are not different than they were before, but we are. For one thing, because of Covid restrictions, we have far less recently acquired immunity; as a group, more of us are vulnerable right now. And that increase in susceptibility, experts suggest, means we may experience some … wonkiness as we work toward a new post-pandemic equilibrium with the bugs that infect us. * * *

Marion Koopmans, head of the department of viroscience at Erasmus Medical Center in Rotterdam, the Netherlands, said she believes we may be facing a period when it will difficult to know what to expect from the diseases that we thought we understood.

“I do think that’s possible,” Koopmans said.

This phenomenon, the disruption of normal patterns of infections, may be particularly pronounced for diseases where children play an important role in the dissemination of the bugs, she suggested.

Ruh roh.

From the Rx coverage front, Fierce Healthcare reports

Prime Therapeutics cut per member per month drug costs by 26% in one year through its MedDrive program, which leverages biosimilars to help drive down expenses.

The program uses advanced analytics to flag ways that health plans can cut down drug spend, with a particular focus on the potential of biosimilars. Pharmacy benefit managers are betting on biosimilar products to introduce new competition to popular branded products and drive down costs.

Prime, which serves 33 million members across 23 Blue Cross Blue Shield plans, first launched MedDrive in May 2021 and in its first year the program drove savings by focusing on just three biosimilar categories, the PBM said. Cancer drugs led the way for savings.

The International Foundation of Employee Benefits Plans adds

The U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced the availability of a final guidance for industry entitled “Importation of Prescription Drugs Final Rule Questions and Answers.” The guidance is intended to help small entities comply with the final rule entitled “Importation of Prescription Drugs.” The final rule was issued to implement a provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow importation of certain prescription drugs from Canada.

In OPM news, OPM announced a group of new staff appointees at the agency today including a new General Counsel and a new Deputy General Counsel.

From the miscellany department —

  • Rebecca G. Baker, Ph.D., the director of the NIH HEAL Initiative, shares insights gained from the Third Annual HEAL Investigators Meeting. HEAL is an NIH branch that focus on creating solutions to the opioid epidemic.
  • EHR Intelligence discusses how a National Patient Identifier could boost population health. It is mystifying that Congress has not released funds for this important initiative.
  • The Medical Group Management Association identifies four ways medical groups can remove barriers to mammography compliance.
  • Health Payer Intelligence outlines 2022 actions today by the U.S. Preventive Services Task Force.

Despite rising availability in online transparency tools, consumers remain unsure about costs and avoid care as a result, a new survey has found.

The annual consumer sentiment survey was conducted in January 2022 by Healthsparq, a health tech company, and reached more than 1,000 insured Americans. Transparency tools were defined as those provided by payers such as in-network provider search, cost estimates and information on treatment. 

The majority (70%) of respondents knew that their health plan offered these, up from 49% last year, and most had used them in the past year. They also said this access helps them better understand their coverage and manage costs. Yet nearly half reported avoiding care due to unclear costs, up from a quarter last year. Care avoidance was even more pronounced among those under the age of 34, at 63%. 

Mark Menton, Healthsparq’s general manager, told Fierce Healthcare he suspects that is because the tools exist, but consumers do not know how to access the information.

“I think that’s a hurdle we as an industry need to overcome,” Menton said. “They don’t know where to find this information.” 

Tuesday’s Tidbits

David Ermer–CDC, COVID-19, Medicare, Mental health care, Rx coverage, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the Omicron and siblings front —

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

The American Hospital Association informs us

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

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

In public health news —

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

In survey news —

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

From the healthcare business front

Fierce Healthcare reports

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

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

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

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

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

The American Hospital Association replies

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

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

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

Also, Healthcare Dive informs us

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

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

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

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

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

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

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

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

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

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

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

Monday Roundup

David Ermer–COVID-19, Rx coverage, SDOH, Telehealth, U.S. Healthcare, Uncategorized–

From the Omicron and siblings front —

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

In other FDA news, MarketWatch informs us

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

That’s helpful.

From the SDOH front —

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

From the preventive care front, Healio reports

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

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

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

From the healthcare business front, Healthcare Dive reports

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

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

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

In other government news —

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

Weekend update

David Ermer–ACA, Congress, COVID-19, Rx coverage, U.S. Healthcare–

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

From the omicron and siblings front, Bloomberg Prognosis reports

People who are vaccinated and then get infected with omicron may be primed to overcome a broad range of coronavirus variants, early research suggests.  

A pair of studies showed that infection produced even better immune responses than a booster shot in vaccinated patients. Teams from Covid-19 vaccine maker BioNTech SE and the University of Washington posted the results on preprint server bioRxiv in recent weeks.

The researchers have found the silver lining in the Omicron cloud.

In other encouraging healthcare news, BioPharma Dive informs us

The Food and Drug Administration on Friday approved Eli Lilly’s diabetes drug Mounjaro, a first-of-its-kind treatment that can help control patients’ blood sugar and, potentially, help them lose weight as well.

Mounjaro, also known as tirzepatide, expands Lilly’s diabetes business, which includes insulins as well as other types of therapies. The company recorded $9 billion in diabetes drugs sales last year.

Mounjaro works by stimulating two hormones, called GLP-1 and GIP, that control insulin production. In clinical testing, the drug outperformed several other diabetes medicines, including one made by rival drugmaker Novo Nordisk that only acts on one hormone. Mounjaro was more effective in controlling blood sugar than two types of insulin as well. * * *

The drug’s approval will heighten competition between Lilly and Novo, which have battled for market share in the U.S. for years. Novo, for instance, has recently had success by launching a similar, once-weekly shot to Lilly’s top-selling drug Trulicity, as well as a daily pill that works the same way.

Novo is testing a dual-acting competitor to tirzepatide, but it’s only in Phase 2 testing, well behind Lilly’s drug. Both companies are also trying to develop a once-weekly insulin shot, with similar programs in Phase 3 development.

The next frontier for both companies is in obesity, where they are working to prove their drugs’ worth as weight loss treatments. Novo has already won approval for a drug called Wegovy, while Lilly reported promising data for Mounjaro last month.

The article adds that Lilly did not disclose pricing for its newly approved drug on Friday.

The FEHBlog also noticed that Katie Keith’s latest article on the Affordable Care Act delves into the recent guidance on posting three machine reading pricing files on health plan websites by July 1. The discussion may be found in the closing paragraphs of the article.

Tuesday’s Tidbits

David Ermer–COVID treatment, COVID-19, Federal employment benefits, Patient safety, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the Omicron and siblings front

  • The Wall Street Journal has updated its article on Covid boosters.
  • The Institute for Clinical and Economic Review (ICER) today released “a Final Evidence Report assessing the comparative clinical effectiveness and value of [specific] outpatient treatments for COVID-19 [, principally Pfizer’s pill Paxlovid and Merck’s pill molnupiravir ].

A majority (11-2) found current evidence is not adequate to demonstrate a net health benefit when molnupiravir is compared to symptomatic care alone.

All panelists (13-0) found that current evidence is adequate to demonstrate a net health benefit when Paxlovid is compared to symptomatic care alone.

Due to uncertainty in the net health benefit for molnupiravir, a majority of panelists voted that it represents “low-to-intermediate” long-term value for money.

A majority of panelists found that Paxlovid represents “high” long-term value for money.

  • ICER presented at the OPM/AHIP carrier conference last month. ICER “is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system.”
  • Speaking of the Covid pills, STAT News discusses the use of telehealth services to prescribe them. The upshot, as the FEHBlog understands it, is while using telehealth for this purpose is convenient for patients, experts are unsure whether the telehealth service provides adequate follow-up care to the patient.

Also, from the Rx coverage front, the Food and Drug Administration issued a news roundup today.

From the healthcare business front, BioPharma Dive reports

Pfizer has agreed to acquire Biohaven Pharmaceuticals for $11.6 billion in a deal that turns an existing alliance on a fast-selling migraine drug into a big bet on its future growth.

Pfizer will pay $148.50 per share in cash for each Biohaven share it doesn’t already own, representing a roughly 79% premium to the company’s Monday closing price and a 33% premium to its average share price of $111.70 over the last three months. The deal, which is expected to close early next year, is by far the biggest biotech buyout of 2022, according to data compiled by Biopharma Dive.

Announced Tuesday, the acquisition hands Pfizer full rights to Nurtec ODT, a pill that’s approved in the U.S. and other countries for the treatment and prevention of migraines. Biohaven’s pipeline also includes an experimental nasal spray for migraines, zavepegant, that’s been submitted to U.S. regulators, as well as five additional, preclinical treatments that block the same protein target.

From the mental health parity front, the Labor Department’s Employee Benefits Security Administration announced that the agency will be holding a mental health parity compliance assistance webcast on May 24 from 2-3 pm ET. Here is a link to the announcement which explains how to register for the webcast.

From the patient safety front, the Leapfrog Group “released the spring 2022 Leapfrog Hospital Safety Grade, which assigns a letter grade to nearly 3,000 U.S. general hospitals based on over 30 measures of patient safety.”

At HospitalSafetyGrade.org, the public can find detailed information about a hospital’s performance on patient experience and other safety measures used to grade hospitals.

Across all states, highlights of findings from the spring 2022 Leapfrog Hospital Safety Grade include:

Thirty‐three percent of hospitals received an “A,” 24% received a “B,” 36% received a “C,” 7% received a “D,” and less than 1% received an “F.”

Five states with the highest percentages of “A” hospitals are North Carolina, Virginia, Utah, Colorado, and Michigan.

There were no “A” hospitals in Wyoming, West Virginia, the District of Columbia, or North Dakota.

From the medical research department, Medscape informs us

Eight modifiable risk factors were linked to more than one in three cases of Alzheimer’s disease and related dementia in the U.S., a cross-sectional analysis showed.

The eight risk factors — midlife obesity, midlife hypertension, physical inactivity, depression, smoking, low education, diabetes, and hearing loss — were associated with 36.9% (95% CI 36.5-37.3) of Alzheimer’s and dementia cases, reported Roch Nianogo, MD, PhD, of the University of California Los Angeles, and Deborah Barnes, PhD, MPH, of the University of California San Francisco, and co-authors.

The factors most prominently associated with Alzheimer’s and dementia were midlife obesity, at 17.7% (95% [Confidence Interval] CI 17.5-18.0); physical inactivity, at 11.8% (95% CI 11.7-11.9); and low educational attainment, at 11.7% (95% CI 11.5-12.0).

“We published a similar study a little more than 10 years ago, and the most important risk factors then were physical inactivity, depression, and smoking,” Barnes told MedPage Today.

“Today, the top three risk factors are midlife obesity, physical inactivity, and low education,” she observed. “This is important because it suggests that the growing number of people who are obese in the U.S. could have a major long-term impact on dementia rates.”

From the clarification front, the FEHBlog often reminds folks that federal employees who retired under the Civil Service Retirement System before 1984 are not eligible for free Medicare Part A. The FEHBlog dug into this issue today, and he discovered this 2013 Reg Jones Q&A on this topic that the Federal Times published.

Q. I retired in 2009 under CSRS. I am close to 65, and the answer to one of the questions asked states that people in CSRS are not eligible for Medicare because they didn’t pay into Social Security.

I was in CSRS before the change to FERS and stayed with CSRS. I had Medicare deductions taken from my pay from 1983-84 till I retired in 2009.

Do the Medicare funds I paid since 1983 make me eligible for Medicare or just part of it?

So which is right? I need to know so I can do what needs to be done — enroll or not. I’m currently insured under federal BCBS.

A. CSRS employees who retired before Dec. 31, 1983, aren’t eligible for Medicare Part A. Nor are CSRS employees who retired after that date but before having Medicare deductions taken from their pay for 10 years.

On the other hand, they are eligible to enroll in Medicare Part B, which is open to everyone 65 or older.

Consequently, the cadre of 65 and older federal annuitants without Medicare A is larger than the FEHBlog understood. This cadre is relevant to the Postal Reform Act because that law keeps Postal annuitants over aged 65 without Medicare Part in the legacy FEHBP.

Friday Stats and More

David Ermer–CDC, COVID-19, COVID-19 vaccine, Rx coverage, U.S. Healthcare–

Based on the CDC’s Covid Data Tracker and using Thursday as the first day of the week, here’s the FEHBlog’s weekly chart of new Covid cases displayed from the 27th week of 2021 through the 18th week of 2022.

The CDC reports in its latest weekly review that “The current 7-day daily average of new Covid hospital admissions for April 27–May 3, 2022, was 2,219. This is a 16.6% increase from the prior 7-day average (1,903) from April 20–26, 2022.

Here’s the FEHBlog’s latest weekly chart of new Covid deaths display from the 27th week of 2021 through the 18th week of 2022.

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

COVID-19 cases and hospitalizations are on the rise in the United States. Although deaths continue to decrease, the United States is expected to reach 1 million deaths soon. * * *

As of May 5, 2022, there are 78 (2.42%) counties, districts, or territories with a high COVID-19 Community Level, 316 (9.81%) counties with a medium Community Level, and 2,826 (87.76%) counties with a low Community Level. This represents a slight (0.75 percentage points) increase in the number of high-level counties, a small (+1.86 percentage points) increase in the number of medium-level counties, and a corresponding (−2.61 percentage points) decrease in the number of low-level counties. Sixteen (28.57%) of 56 jurisdictions had no high- or medium-level counties this week.

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

Here’s the FEHBlog’s weekly chart of Covid vaccinations distributed and administered from the inception of the vaccination program until this 18th week of 2021.

Nearly 75% of the U.S. population aged 12 and older are fully vaccinated and nearly 50% of the U.S. population aged 18 and older have received a booster.

STAT News reports

The White House could run out of Covid-19 vaccines if it moves forward with plans to encourage all adults to get a second Covid-19 vaccine booster dose by roughly Sept. 1, according to a tranche of budget documents sent to Congress that have not previously been made public.

In other CDC news, the American Hospital Association informs us

The Centers for Disease Control and Prevention is investigating 109 potential hepatitis cases of unknown cause in U.S. children since last October, including five deaths. More than 90% of the patients were hospitalized, 14% received liver transplants and more than half had a confirmed adenovirus infection, but officials still don’t know the actual cause of their hepatitis and cautioned that it may take time to assess the evidence and learn more. CDC alerted clinicians to the first cases last month.

To date, 25 states and territories have reported potential cases: Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New York, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Washington and Wisconsin.

Potential cases also have been reported in the United Kingdom and other countries

From the Rx coverage front, Medscape tells us

The US Food and Drug Administration (FDA) has cleared the first in vitro diagnostic to aid in the early detection of Alzheimer’s disease (AD).

The Lumipulse G β-Amyloid Ratio 1-42/1-40 (Fujirebio Diagnostics) test detects amyloid plaques associated with AD in adults age 55 or older who are under investigation for AD and other causes of cognitive decline.

“The availability of an in vitro diagnostic test that can potentially eliminate the need for time-consuming and expensive [positron emission tomography (PET)] scans is great news for individuals and families concerned with the possibility of an Alzheimer’s disease diagnosis,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

“With the Lumipulse test, there is a new option that can typically be completed the same day and can give doctors the same information regarding brain amyloid status, without the radiation risk, to help determine if a patient’s cognitive impairment is due to Alzheimer’s disease,” he added.

From the healthcare business front, Beckers Payer Issues informs us

Cigna reported over $44 billion in total revenues in the first quarter, with the strongest growth in the company’s Evernorth business. Projected revenues at year end stand at $177 billion, according to the company’s earnings report released May 6.

“We’ve had a strong start to the year as we advance our growth strategy and support the health and well-being of our clients and customers,” Chair and CEO David Cordani said. “We’re taking decisive steps forward with innovation, new partnerships and re-investing in our company so we can achieve greater impact for the customers and communities we’re privileged to serve.”

Also, Becker’s Hospital CFO Report tells us

Driven mainly by nonoperating losses, Oakland, Calif.-based Kaiser Permanente recorded a net loss of $961 million in the first quarter of 2022, down from a net income of $2 billion in the same quarter in 2021, according to financial data released May 6. 

For the quarter ending March 31, Kaiser reported total operating revenue of $24.2 billion, up from $23.2 billion the year prior. Tom Meier, corporate treasurer of Kaiser Permanente, said the revenue increase was attributed to several factors, including growth of its health plan. 

Kaiser also saw its expenses increase significantly in the first quarter of 2022 to $24.3 billion, up 9.5 percent from the same quarter last year. Mr. Meier said the health system incurred about $1.4 billion in costs from COVID-19, including $900 million for the cost of care, $550 million for testing and $50 million for vaccinations. 

In related news, Govexec reports

USPS saw a net loss of $639 million in the period between Jan. 1 and March 31, up from $82 million in the same period last year. The Postal Service Reform Act was not enshrined into law until after the second quarter of fiscal 2022, meaning the relief it will provide by eliminating the requirement that the Postal Service prefund health care costs for future retirees was not reflected in the financial results. USPS grew revenue in the quarter by about $900 million, a 5% increase from the same period in 2021. Volume grew by about 3%. 

Federal News Network adds

Postmaster General Louis DeJoy expects the Postal Service will need to keep raising prices on its monopoly mail products for the foreseeable future, as part of a 10-year reform plan to improve its long-term financial health.

DeJoy said Thursday said the mailing industry needs to be prepared for USPS to raise prices on its market-dominant products “at an uncomfortable rate,” until it reaches a point where the agency is on track to be self-sustaining in the long term.

As we approach Mothers’ Day this weekend, the American Hospital Association tells us

The Health Resources and Services Administration will launch May 8 a toll-free hotline for expecting and new mothers experiencing mental health challenges, where trained counselors will provide brief interventions and referrals to community-based and telehealth providers as needed. Callers also will receive evidence-based information and referrals to support groups and other community resources.

“Today, we are creating a safe space for expecting and new moms who are experiencing maternal depression, anxiety or other mental health concerns to have confidential conversations and get the support they need,” said HRSA Administrator Carole Johnson. “Moms can call or text 1-833-9-HELP4MOMS and connect with a counselor at no charge. We are going to continue to grow our investments in this resource, as we know it’s what women need.”

Nothing is too good for our Moms.