Holiday weekend update

COVID-19

Holiday weekend update

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

Congress remains on the campaign trail this coming.

The Medicare Open Enrollment period begins on Saturday, October 15. The New York Times adds

Social Security will soon announce the largest inflation adjustment to benefits in four decades — a welcome development for millions of older Americans struggling to keep up with fast-rising living costs.

The cost-of-living adjustment for 2023 is likely to be around 8.7 percent, based on the latest government inflation figures. The final COLA, as the adjustment is known, will be released Thursday, when the federal government announces inflation figures for September. Medicare enrollees can anticipate some additional good news: The standard Part B premium, which is typically deducted from Social Security benefits, will decline next year.

The COLA, one of Social Security’s most valuable features, will give a significant boost to more than 70 million Americans next year. While retirement comes to mind when most people think about Social Security‌, the program plays a much broader role in providing economic security.

In August, the program paid benefits to 52.5 million people over age 65, but younger beneficiaries — survivors of insured workers and recipients of disability benefits‌ and Supplemental Security Income, the program for very low income people — added 17.9 million people to the total, according to Social Security Administration data.

The Federal Times discusses the upcoming open enrollment for the Federal Employee Dental and Vision Programs.

Twelve dental carriers provide 23 dental plan options available across the program. Seven dental carriers offer fourteen nationwide dental plan options available to all potential enrollees. Five vision carriers provide 10 nationwide vision plan options available to all potential enrollees.

The FEHB, FEDVIP, and FSAFeds Programs share the same open enrollment season, which this year will run from November 14 to December 12.

The health insurance marketplace open enrollment period begins on November 1, 2022, and ends on January 23, 2023.

From the public health front —

  • The New York Times discusses why Americans need a flu shot. As to timing

Immunity against the flu tends to wane over the course of a season. You have higher protection a couple of weeks after receiving the shot, compared with four or five months later, so it is a good idea to schedule your vaccine appointment close to the beginning of flu season, and not too early, Dr. Martin said. “I tend to get vaccinated in October so my antibodies are ramped up by the time holiday travel begins,” she said.

Some people wait longer, until November or December, especially if they are keeping a close eye on cases. But experts agree that it is important to receive the vaccine before cases start to surge. Your body needs at least two weeks after the shot to ramp up its defenses against the flu. People who are more susceptible to severe flu — especially older adults, pregnant women and very young children — should not delay their shots.

  • MedPage Today reports “Long COVID Persists in People With Symptomatic SARS-CoV-2 Infection — At one year, 15% of long COVID patients had ongoing cognitive or respiratory problems or fatigue.” Fierce Healthcare delves into health plan coverage of this tricky disease.
  • The New York Times offers expert opinions about various aspects of monkeypox.

From the healthcare personnel front, Healthcare Dive reports

Effective Oct. 17, [Amar] Desai who [currently is President and Chief Executive Officer, Optum Pacific West] will lead CVS’ newly created health care delivery division, overseeing implementation of CVS’ health services and care delivery strategy, according to a release from the Woonsocket, Rhode Island-based company. That includes CVS’ clinical delivery strategy in retail health, chronic disease management and behavioral health.

The division will work to link different aspects of CVS’ portfolio to develop payer-agnostic products and services, according to CEO Karen Lynch.

Good luck, Mr. Desai.

From the medical research front —

  • STAT News tells us about a large “gold-standard” European study concluding that colonoscopies are not all they have been cracked up to be in the U.S.

The trial’s primary analysis found that colonoscopy only cut colon cancer risk by roughly a fifth, far below past estimates of the test’s efficacy, and didn’t provide any significant reduction in colon cancer mortality. Gastroenterologists, including Bretthauer, reacted to the trial’s results with a mixture of shock, disappointment, and even some mild disbelief.

It’s the first randomized trial showing outcomes of exposing people to colonoscopy screening versus no colonoscopy. And I think we were all expecting colonoscopy to do better,” said Samir Gupta, a gastroenterologist at the University of California, San Diego and the VA who didn’t work on the trial. And, he said, it raises an uncomfortable question for doctors. “Maybe colonoscopy isn’t as good as we always thought it is.”

He stressed that the study does not invalidate colonoscopies as a useful screening tool. Colonoscopies are still a good test, Gupta said, but it may be time to reevaluate their standing as the gold standard of colon cancer screens. “This study provides clear data,” he said, “that it’s not as simple as saying, ‘Colonoscopy is the most sensitive test, and therefore it is the best.’ It still prevented cancers.”

The study has not shattered the FEHBlog’s confidence in the procedure, but it’s worth discussing the study with your physician down the line.

  • Bloomberg prognosis reports, “AstraZeneca Plc’s nasal spray vaccine failed to elicit a strong immune response to Covid-19 in a [small] early trial, a blow to the U.K. drU.K. giant’s ambitions for developing an alternative approach to preventing the disease.”

Friday Stats and More

David Ermer–CDC, COVID-19, Federal employment benefits, Mental health care, OPM, Rx coverage, U.S. Healthcare–

Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s latest weekly chart of new Covid cases.

The CDC’s Covid Data Tracker Weekly Review was not issued today because Monday is a federal holiday.

The Covid Weekly Tracker tells us that the daily average of new Covid hospital admissions is 3,35.

Here is the FEHBlog’s latest weekly chart of new Covid deaths.

New York Times columnist David Leonhardt, who is going on a book tour that ends in late January 2023, reports

“A large chunk of deaths are preventable right now with Paxlovid alone,” Dr. Ashish Jha, the White House Covid response coordinator, told me. He predicted that if every American 50 and above with Covid received a course of either Paxlovid or a treatment known as monoclonal antibodies, daily deaths might fall to about 50 per day, from about 400 per day in recent months. * * *

A recent analysis of about 568,000 patients by Epic Research found that 0.016 percent of Covid patients over 50 who received Paxlovid died. The death rate for patients who did not get the drug was more than four times higher, or 0.070 percent. And yet the Epic data showed that only about 25 percent of patients eligible to receive Paxlovid actually did, even though the drug is widely available and free for patients.

Perhaps the most shocking statistic about Paxlovid’s underuse — and Jha used the word “shocking” when describing it to me — is that a smaller share of 80-year-olds with Covid in the U.S. is now receiving the drug than 45-year-olds with Covid, according to data he has seen. Many doctors are evidently worried about side effects or rebound cases among their more vulnerable patients.

Even in rebound cases, however, symptoms tend to be milder than they would have been without Paxlovid. After Dr. Anthony Fauci, another White House adviser, who’s 81, contracted Covid in June and then took Paxlovid, he experienced a rebound — and also believed that the drug kept him out of the hospital.

“Medicine is about weighing costs and benefits,” Wachter said. “The recommendation should be clear and unambiguous for people at high risk: The benefits of the drug outweigh the downsides.”

In contrast, STAT News reports

A Merck pill used to combat Covid-19 failed to demonstrate it can lower the risk of hospitalization compared with a placebo among adults at a higher risk from the disease, according to the results of a large study conducted in the U.K.

The preliminary results of the randomized trial, which involved more than 25,000 participants, showed that taking molnupiravir did speed time to recovery by about six days, which means that patients did get some relief. Otherwise, though, the study failed to reach an outcome that had been used late last year by regulators — such as those in the U.S. and U.K. — to authorize the medicine to thwart the pandemic.

The findings also contradict the results of a much smaller study conducted by Merck and its partner, Ridgeback Therapeutics, which found a lower risk of hospitalization or death in high-risk patients by roughly 30%, after initially showing a 50% lower risk. Unlike the latest trial, which is called Panoramic, the Merck trial called Move-Out excluded patients who had been vaccinated against the coronavirus.

Here is the FEHBlog’s chart of Covid vaccinations distributed and administered from the beginning of the Covid vaccination era in December 2020 through the 40th week of 2022:

In addition, here are two related CDC charts.

The American Hospital Association adds

COVID-19 vaccinations are associated with over 650,000 fewer hospitalizations and 300,000 fewer deaths in the Medicare population through December 2021, saving an estimated $16 billion in direct medical costs, the Department of Health and Human Services reported today. 

“This report reaffirms what we have said all along: COVID-19 vaccines save lives and prevent hospitalizations,” said HHS Secretary Xavier Becerra. “We now have updated COVID vaccines designed to protect you against the Omicron strain of COVID that makes up almost all COVID cases in the U.S. … Over 90 percent of Americans live within 5 miles of where they can access these vaccines for free. I urge everyone eligible to get an updated COVID vaccine to protect yourself ahead of the fall and winter.”

Govexec tells us The Office of Personnel Management on Thursday announced that it authorized paid leave for federal workers to obtain the latest round of boosters for the COVID-19 vaccine.

From the FEHB front, Health Payer Intelligence reviews 2023 Blue Cross FEP benefit changes and makes other Open Season observations.

In OPM news, the GSA announced that its Technology Modernization Fund will be investing in OPM’s website.

OPM.gov Modernization

It can be challenging for federal employees, job seekers, and HR professionals to navigate OPM.gov’s 20,000 pages to find what they need. With a $6 million TMF investment, OPM will update both the technology behind and the content on the OPM.gov website. This will allow OPM to implement an updated and more secure Content Management System (CMS) hosted on OPM’s cloud environment, ensuring that users have intuitive and accessible web tools.

“A user-friendly website plays a critical role in OPM’s mission to communicate the federal government’s policies, services, and benefits more clearly and effectively,” said OPM Director Kiran Ahuja. “This investment will improve the government’s ability to recruit job seekers, supply the federal workforce with relevant career-related information, and make it easier for public servants to manage their benefits.”

Hope springs eternal.

From the mental healthcare front, Fierce Healthcare informs us

A mental health crisis besets young adults in the United States to such an extent that more than a third (35%) of individuals ages 18 through 29 years old said that they could not work nor engage in other activities of daily living, according to a new survey by the Kaiser Family Foundation (KFF) and CNN.

Meanwhile, 90% of all Americans believe that the country faces a mental health crisis.

Age 30 seems to be the cutoff separating severe crisis caused by mental health problems, and conditions not as dire. For instance, 34% of those 18 through 29 consider their mental health to be “only fair” or “poor”; 19% of those 30 and over feel that way. Fifty-two percent of young adults said that they’d always or often felt anxious in the last year, while 28% of older adults felt that way.

A third of young adults felt depressed (33%) or lonely (32%) in the last year; for older adults it was 18% for both depressed and lonely. 

These survey figures, particularly the first one, are hard to believe, but undoubtedly our country needs more mental health therapists and better treatments.

From the Rx coverage front, the Food and Drug Administration announced that the agency has

approved Boostrix (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed [Tdap]) for immunization during the third trimester of pregnancy to prevent pertussis, commonly known as whooping cough, in infants younger than two months of age. 

“Pertussis disease is a highly contagious respiratory illness affecting all age groups. However, babies are at highest risk for getting pertussis and having serious complications from it,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “While vaccination is the best method for providing protection, infants younger than two months of age are too young to be protected by the childhood pertussis vaccine series. This is the first vaccine approved specifically for use during pregnancy to prevent a disease in young infants whose mothers are vaccinated during pregnancy.” 

Pertussis is a common respiratory disease in the United States, resulting in frequent outbreaks. It is also called whooping cough because of the “whooping” sound that someone makes when gasping for air after a fit of coughing. Most serious pertussis cases, hospitalizations and deaths occur in infants younger than two months of age who are too young to be protected by the childhood pertussis vaccine series. According to the Centers for Disease Control and Prevention (CDC), 4.2% of the total cases of pertussis reported in the United States in 2021 were in infants younger than 6 months of age and approximately 31% required hospitalization. When the Boostrix vaccine is given during pregnancy, it  boosts antibodies in the mother, which are transferred to the developing baby. 

Good news.

From the healthcare business front, Fierce Healthcare reports

Yale New Haven Health has signed an agreement to acquire two Connecticut health systems, Waterbury HEALTH and Eastern Connecticut Health Network), from Prospect Medical Holdings.

The deal would give Connecticut’s largest health system the businesses, real estate, physician clinic operations and outpatient services of three hospitals: 357-bed Waterbury Hospital, 249-bed Manchester Memorial Hospital and 102-bed Rockville General Hospital. Also included are Prospect Provider Group of Connecticut and Visiting Nurse and Health Services of Connecticut, according to a release.

Midweek update

David Ermer–CDC, CMS, Congress, COVID-19, HSA, OPM, Patient safety, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From the OPM front, Federal News Network reports on the Senate Homeland Security and Governmental Affairs September 29, 2022, confirmation hearing for Robert Shriver, whom the President has nominated to serve as OPM Deputy Director.

From the Fourth Quarter 2022 front

  • STAT News provides “The Q4 health tech tracker: 17 key industry events and milestones to watch.”
  • The Society for Human Resource Management offers “4th Quarter 2022 ‘Quick Hits’ for Plan Sponsors.” This quick hit grabbed the FEHBlog’s attention:

Making a splash across the headlines was the Inflation Reduction Act of 2022(IRA), which President Biden signed on Aug. 16, 2022. The 273 pages of text make sweeping changes. However, few will affect employer-sponsored benefit plans, and most of those will have only indirect effects. 

One change that does directly affect a High Deductible Health Plan (HDHP) is the exception added to Section 223 of the Internal Revenue Code effective for plan years beginning after Dec. 31, 2022, to enable HDHPs to cover the cost of insulin without first meeting the deductible. This first dollar coverage for insulin will protect Health Savings Account (HSA) eligibility for those who require an insulin regimen. Employers should determine if their plan requires an amendment to implement this change.

On a related note, TRI-AD calls to our attention the “2022 FSA relief provisions will no longer apply in 2023.”

From the public health front —

  • The American Hospital Association informs us that “Increasing bivalent COVID-19 booster vaccinations this year to 2020-2021 flu vaccination rates could prevent an additional 75,000 deaths and 745,000 hospitalizations and avert $44 billion in medical costs over the next six months, researchers estimate in a Commonwealth Fund blog post. Increasing COVID-19 booster coverage to 80% of eligible Americans aged five and older this year could prevent about 90,000 deaths and over 936,000 hospitalizations and avert $56 billion in medical costs, they add.”
  • CNBC reports

* The CDC, in a report, said monkeypox could spread indefinitely at a low level in the U.S.

* Monkeypox is unlikely to be eliminated from the U.S. in the near future, according to the CDC. 

* The outbreak is slowing as the availability of vaccines have increased and people have become more aware of how to avoid infection.

  • The New York Times gives us a briefing and advice on the upcoming flu season.
  • Beckers Hospital Review discusses patient safety wins obtained this year by five health systems.

From the innovations front, the American Hospital Association tells us

The Centers for Medicare & Medicaid Services seeks comments through Dec. 6 on creating a National Directory of Healthcare Providers and Services to help patients locate providers and compare health plan networks, and reduce directory maintenance burden on providers and payers.

CMS seeks feedback on the concept and potential benefits; provider types and data elements to include; the technical framework for a national directory; priorities for a possible phased implementation; and prerequisites and actions CMS should consider to address potential challenges and risks.

Tuesday Tidbits

David Ermer–CDC, Congress, COVID-19, Electronic health records, Federal employment benefits, Medicare, Mental health care, OPM, Telehealth, U.S. Healthcare–

From the Federal Employee Benefits Open Season front, OPM released its Open Season press announcement today. Its lede is

Thousands of Enrollees Are Leaving Valuable Savings on the Table During Open Season
Enrollees should use Open Season as a period to conduct a wellness or financial check-up and reassess their health needs and coverage

Among other guidance, OPM recommends

Below we’ve provided sample questions to help you assess how you can utilize Open Season to review your benefits and needs to make an informed decision on coverage:

What are my and/or my family’s expected health care needs for 2023? 

* Questions while reviewing your FEHB plan: Am I expecting a new baby? Do I need surgery? Will my medication need change? Does my plan provide a pharmacy mail order option for prescriptions?

* Questions while reviewing FEDVIP: Do I want coverage for my routine dental care? Will I need a crown or root canal? Does my child need braces? Do I need glasses and/or contact lenses? Am I considering laser vision correction surgery?

* Questions while reviewing FSAFEDS: Do I have out-of-pocket expenses I need to consider, such as deductibles, copays, day care, elder care, or over-the-counter drugs and medicines? Do I have medical expenses that may not be covered by my FEHB plan? Do I plan to send my children (under 13) to in-home care or summer camp? 

OPM does not mention the availability of the FEHB plan’s summary of benefits and coverage (“SBC”), an Affordable Care Act requirement. The FEHBlog recalls visiting friends in Denver who were preparing for their employers’ open season by comparing these short but comprehensive SBCs. For example, the SBCs include a broken-out estimate of the plan’s cost-sharing for having a baby, receiving diabetes treatment for a year, and fixing a broken bone. In addition, the federal government consumer tested the SBCs.

FEHB plans update their SBCs annually in advance of Open Season and post them on their websites, usually on the page with forms and brochures.

The Washington Post has an article on the 2023 Open Season, and Federal News Network offers “a few” other expert views on the 2023 Open Season. Fierce Healthcare adds

Open enrollment is coming soon, and foremost on everybody’s mind as these windows draw nearer is just how much health insurance will cost, according to a survey by Gravie and Wakefield Research.

“Consumers are concerned about the high costs of health coverage impacting their access to healthcare, increasing medical debt and the lack of mental health coverage,” according to a press release from the two companies.

From the Omicron and siblings’ front —

  • Beckers Hospital Review tells us

The CDC revised its “up to date” COVID-19 vaccination term Sept. 30 to include the primary series and the recently authorized omicron-targeting booster.  * * *

The CDC’s website still deems people who are not immunocompromised as “fully vaccinated” two weeks after their second dose of Moderna or Pfizer’s series or two weeks after receiving J&J’s COVID-19 vaccine. 

[However, last Friday’s] decision could update the “fully vaccinated” term that experts have urged regulators to update.

  • HealthLeaders Media reports “Treating COVID-19 patients with Paxlovid significantly reduces hospitalizations and deaths, according to a recent large-scale study by Epic Research.”

AstraZeneca’s Covid-19 pre-exposure prophylactic Evusheld has managed to remain relevant for immunocompromised and other patients when many of its therapeutic peers haven’t with each new Omicron subvariant.

But that win streak may slowly come to a close as the FDA told healthcare providers on Monday that one of the emerging subvariants, BA.4.6, renders Evusheld almost completely useless.

Nationally, BA.4.6 currently makes up about 13% of new cases, compared to just 1% of cases at the beginning of July, according to the CDC. But in some regions, like in Iowa, Missouri, Kansas and Nebraska, the BA.4.6 subvariant makes up more than 20% of all Covid-19 cases.

  • David Leonhardt writing in the New York Times Morning column discusses “A Public Health Success Story; We revisit the subject of Covid and racial inequities”. Check it out.
  • The NIH Directors Blog considers “Understanding Long-Term COVID-19 Symptoms and Enhancing Recovery.”

From the mental healthcare front, MedPage Today reports

Suicide risk was higher in people recently diagnosed with dementia, especially younger patients, a case-control study in England showed.

Compared with people who didn’t have dementia, suicides rose in people who received a dementia diagnosis in the past 3 months (adjusted OR 2.47, 95% CI 1.49-4.09), according to Danah Alothman, BMBCh, MPH, of the University of Nottingham in England, and colleagues.

For people under age 65, suicide risk within 3 months of diagnosis was 6.69 times (95% CI 1.49-30.12) higher than in patients without dementia, the researchers reported in JAMA Neurology

From the U.S. healthcare business front, Bloomberg reports on giant drug manufacturer Pfizer’s future

Pfizer Inc. emerged from the Covid-19 pandemic as the world’s most visible drugmaker, but its success has left investors impatient for an encore.

The windfall from the pharmaceutical giant’s Covid vaccine almost doubled its revenue in just one year. And now the shot, coupled with Pfizer’s Covid antiviral pill, is poised to make up more than half of its expected $100 billion of sales in 2022. That’s left Pfizer flush with cash — $28 billion it could spend on the kinds of deals that for decades fueled its growth into an American colossus.

The pressure is clearly on for Pfizer to show that the muscle it built during the pandemic won’t atrophy. Big Pharma companies don’t normally double revenue so quickly, and nobody expects that kind of growth to continue. But one thing’s clear: Pfizer can’t go back to the sluggish path it was on for years.

The American Hospital Association informs us

Operating margins for U.S. hospitals and health systems were down 24% in August compared to a year ago, driven in large part by a 7.2% increase in labor expenses, according to data from over 900 hospitals reported yesterday by Kaufman Hall.

“Nine months into a challenging year, margins have fluctuated wildly,” the report notes. “Although most metrics improved from July to August, organizations are still operating with negative margins and well below pre-pandemic levels.”

From the Medicare front, the American Hospital Association adds

Effective Oct. 1 for five years, the Centers for Medicare & Medicaid Services will pay average sales price plus 8%, rather than ASP plus 6%, for biosimilars whose average sales price does not exceed the price of the reference biological product. The payment increase was included in the Inflation Reduction Act of 2022. For new biosimilars that qualify, the five-year period will begin on the first day of the calendar quarter for which ASP payment for that biosimilar begins under Medicare Part B.

From the electronic health records front, STAT News reports

Epic Systems has revamped its widely criticized sepsis prediction model in a bid to improve its accuracy and make its alerts more meaningful to clinicians trying to snuff out the deadly condition.

Corporate documents obtained by STAT show that Epic is now recommending that its model be trained on a hospital’s own data before clinical use, a major shift aimed at ensuring its predictions are relevant to the actual patient population a hospital treats. The documents also indicate Epic is changing its definition of sepsis onset to a more commonly accepted standard and reducing its reliance on clinician orders for antibiotics as a way to flag the condition.

The changes follow the publication of a series of investigations by STAT that found an earlier version of Epic’s tool resulted in high rates of false alarms at some hospitals and failed to reliably flag sepsis in advance. One of the investigations found that the model’s use of antibiotics as a prediction variable was particularly problematic, resulting in late alarms to physicians who had already recognized the condition and taken action to treat it.

Fierce Healthcare looks into “How Google, Mayo Clinic and Kaiser Permanente tackle AI bias and thorny data privacy problems.”

From the telehealth front, Healthcare Dive reports

Telehealth utilization varied by region from June to July of 2022 and rose 1.9% nationally, according to Fair Health’s monthly tracker data out Monday. 

In the West, Midwest and South, telehealth utilization rose 5.7%, 2.5% and 4.9%, respectively, from June to July. In the Northeast, telehealth use fell 3.3% during that period.

Mental health conditions remained the top diagnoses nationally, and psychiatrists also delivered more virtual care in some regions.

Weekend update

David Ermer–CDC, CMS, Congress, COVID-19, COVID-19 vaccine, Rx coverage, Telehealth–

Congress has left Capitol Hill after the Congressional election on November 8. The Wall Street Journal reports from the Congressional campaign trail.

Tomorrow, the Supreme Court opens its October 2023 Term. The Journal discusses the legal issues that the Court will be considering this term.

Amy Howe adds

When the justices return to the bench next week to begin the 2022-23 term, members of the public will be able to attend oral arguments for the first time since the COVID-19 pandemic began in 2020. The court also announced on Wednesday that it will continue to provide a live audio feed of oral arguments, a practice that it began during the pandemic.

Masking will be optional at oral arguments, the court said in a press release, and the court’s building will otherwise remain closed to the public.

From the Omicron and siblings front, Forbes reports

As COVID-19 regulations continue to ease across the U.S., some Americans want more protection. Nearly two-thirds (63%) of adults familiar with the recently updated booster shot, which specifically targets the virus’ Omicron variant, say they are likely to get one.

That’s according to the latest Forbes Health-Ipsos Monthly Health Tracker, which polled 1,120 adults between Sept. 27 and 28, 2022. Of those in favor of the new shot, 25% say they are “somewhat likely” to get it, while 38% indicate they are “very likely” to get the booster.

Additionally, about 9% of polled individuals have already received the latest booster, and 28% say they aren’t likely to get this particular booster at all.

Perhaps it’s time for health plans to reach out to members on the bivalent booster.

From the healthcare costs front, the Congressional Budget Office offers “Policy Approaches to Reduce What Commercial Insurers Pay for Hospital and Physician Services.” How timely!

From the Rx coverage front —

Fierce Healthcare tells us

A new report finds that 1,216 pharmaceuticals increased their prices past the inflation rate of 8.5% from July 2021 to July 2022, with an average hike of 31.6%. 

The report and a second report on price trends released Friday by the Department of Health and Human Services (HHS) underline how a new provision in the Inflation Reduction Act—an inflationary cap on Part D costs—will affect prices right as the cap is implemented Oct. 1. 

NPR shots provides patient and expert reaction to the FDA’s decision to approve a new drug to treat amyotrophic lateral sclerosis (“ALS”).

The Food and Drug Administration has approved a controversial new drug for the fatal condition known as ALS, or Lou Gehrig’s disease. 

The decision is being hailed by patients and their advocates, but questioned by some scientists.

Relyvrio, made by Amylyx Pharmaceuticals of Cambridge, Mass., was approved based on a single study of just 137 patients. Results suggested the drug might extend patients’ lives by five to six months, or more. * * *

A much larger study of Relyvrio, the Phoenix Trial, is under way. But results are more than a year off.

The Institute for Clinical and Economic (ICER) review adds

Yesterday, the FDA approved Relyvrio, Amylyx Pharma’s therapy for amyotrophic lateral sclerosis (ALS). According to ICER’s analysis, the therapy would only achieve traditional thresholds of cost-effectiveness if priced between $9,100 to $30,700 per year.

We also recommended that manufacturers should seek to set prices of new medications that will foster affordability and access for all patients by aligning prices with the patient-centered therapeutic value of their treatments, and not based on the price of existing ALS medications. This is especially important for ALS since new drugs are anticipated to be used in combination with other very expensive drugs, creating the highest risk for financial toxicity due to health care costs.

From the telehealth front, mHealth Intelligence informs us

While researching the effects of telehealth and in-person care within a large integrated health system, a study published in JAMA Network Open found that virtual care methods can expand healthcare capabilities, performing on par or better than in-person care on most quality measures evaluated.

Researchers conducted a retrospective cohort study that included 526,874 patients, 409,732 of whom received only in-person care, and 117,142 participated in telehealth visits. Of those who received only in-person care, 49.7 percent were women, 85 percent were non-Hispanic, and 82 percent were White. Of those who received care via telehealth, 63.9 percent were women, 90 percent were non-Hispanic, and 86 percent were White.

Researchers noted that patients in the in-person-only group performed better on medication-based measures. But only three of the five measures had significant differences: patients with cardiovascular disease (CVD) receiving antiplatelets, those with CVD receiving statins, and those with upper respiratory infections avoiding antibiotics.

Researchers also noted that patients participating in telehealth performed better than those in the -person-only group on four testing-based measures. These four measures included patients with CVD with lipid panels, patients with diabetes with hemoglobin A1c testing, patients with diabetes with nephropathy testing, and blood pressure control.

Further, those participating in telehealth performed better than their counterparts on seven counseling-based measures, including cervical cancer screening, breast cancer screening, colon cancer screening, tobacco counseling and intervention, influenza vaccination, pneumococcal vaccination, and depression screening.

Based on these study findings, researchers concluded that telehealth could augment care for various conditions, especially chronic diseases. The study also supplies information that could assist providers in determining an ideal ratio of in-person and telehealth visits.

But researchers also noted several limitations associated with the study. These included their inability to control for the number of in-person and telehealth visits, potential inaccuracies associated with the EMR data used, and sampling limitations.

Friday Stats and More

David Ermer–CDC, Congress, COVID-19, OPM, U.S. Healthcare–
OPM Headquarters, a/k/a the Theodore Roosevelt Building

Today’s leading stats are FEHB, not Covid related.

This afternoon, OPM released the 2023 FEHB and FEDVIP premiums with a lengthy announcement and a link to those premiums.

Govexec explains

Federal employees and retirees will spend an average of 8.7% more on their health insurance premiums in 2023, a figure that marks the highest cost increase in more than a decade.

The government’s share of Federal Employees Health Benefits Program premiums will increase by an average of 6.6%, bringing the overall increase to 7.2%, according to an OPM document obtained by Government Executive. That overall premium increase is the highest the nation’s largest health insurance program has seen since costs increased 9% in 2011.

On average, federal employees enrolled in “self-only” plans will pay an additional $8.11 per bi-weekly pay period, while feds in “self plus one” insurance plans will pay $20.34 more per pay period. Federal workers enrolled in family coverage will pay an average of $20.87 more per pay period in 2023.

For the Federal Employees Dental and Vision Insurance Program, the average premium for dental plans will increase by 0.21%, while the overall average premium for vision coverage will decrease by 0.41%.

If you follow the FEHBlog’s U.S. healthcare cost posts, you know that this FEHB premium increase is in line with what other large employers are experiencing. As readers know, the 8.7% average increase assumes no one changes plans in Open Season. The FEHBlog thinks that OPM emphasizes this number to encourage federal employees and annuitants to shop for lower-priced coverage.

Here are the Federal News Network and Federal Times articles on this development.

From the Omicron and siblings front, here is the CDC’s weekly interpretative summary of its Covid statistics, which the FEHBlog continues to track.

As of September 28, 2022, the current 7-day moving average of daily new cases (47,112) decreased 13.1% compared with the previous 7-day moving average (54,202).

CDC Nowcast projections* for the week ending October 1, 2022, estimate that the combined national proportion of lineages designated as Omicron will continue to be 100%. There are five sublineages designated as Omicron: BA.5, BA.4.6, BF.7, BA.2.75, and BA.4. The predominant Omicron lineage is BA.5, projected to be 81.3% (95% PI 79.6-83.0%).

The current 7-day daily average for September 21–27, 2022, was 3,733. This is a 7.4% decrease from the prior 7-day average (4,029) from September 14–20, 2022.

The current 7-day moving average of new deaths (344) decreased 6.7% compared with the previous 7-day moving average (368). 

As of September 28, 2022, 619.8 million vaccine doses have been administered in the United States. Overall, about 264.1 million people, or 79.5% of the total U.S. population, have received at least one dose of vaccine. About 225.3 million people, or 67.9% of the total U.S. population, have completed a primary series.

Of those who have completed a primary series, about 110.0 million people have received a booster dose,* and more than 7.5 million people have received an updated (bivalent) booster dose. But 49.8% of the total booster-eligible population has not yet received a booster dose. 

From Capitol Hill, Roll Call reports

The House cleared a temporary spending bill needed to avoid a partial government shutdown ahead of Friday night’s deadline, giving lawmakers a reprieve until after the midterm elections when they’ll need to figure out a longer-term funding plan for the fiscal year ending Sept. 30, 2023.

The measured passed on a 230-201, mostly party-line vote and will now be sent to President Joe Biden’s desk where he’s expected to sign it later on Friday. The Senate passed the measure Thursday, 72-25, after that chamber resolved some last-minute holds. 

The extension is through December 16, 2023.

Pension and Investments Online reports “More than 14 months after her nomination, the Senate on Thursday confirmed Lisa M. Gomez as assistant secretary of labor for the Employee Benefits Security Administration in a 49-36 vote.” EBSA is one of the Affordable Care Act and No Surprises Act regulators, which impacts FEHB. Good luck.

From the U.S. healthcare business front, Healthcare Dive informs us that the Justice Department has not appealed a September 19, 2022, federal district court rejecting the federal government’s challenge to United Healthcare’s acquisition of Change Healthcare.

[T]he DOJ could still appeal the UnitedHealth-Change ruling. Its earlier deal reached with UnitedHealth doesn’t prevent DOJ from appealing. 

“In any challenge to a merger, it is always beneficial for those challenging it to seek to have the merger enjoined before the matter actually closes,” Jim Burns, a partner at Williams Mullen and chair of its Antitrust and Trade Regulation Practice Group, told Healthcare Dive. 

But all signs indicate that the DOJ has decided not to appeal, a former government official with antitrust expertise told Healthcare Dive. 

To alleviate other antitrust concerns, UnitedHealth agreed to divest ClaimsXten to private equity group TPG Capital.

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, Medicare, Mental health care, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Capitol Hill, the American Hospital Association reports

The Senate today voted 72-25 to pass and send to the House a continuing resolution that would extend current federal funding levels for health care and other programs through Dec. 16. Current government funding expires at midnight Sept. 30.

The legislation also would extend through Dec. 16 two expiring programs that help maintain access to care in rural communities: the Medicare-dependent Hospital and enhanced Low-volume Adjustment programs. AHA will continue to advocate for long-term extension of these programs. Among other provisions, the continuing resolution would reauthorize the Food and Drug Administration’s user fee programs, and provide emergency funding for Ukraine and disaster assistance.

A proposal dealing with energy-permitting plans was dropped from the measure on Tuesday, speeding passage of the legislation. The House is expected to pass the measure by Friday. 

Roll Call provides more background on the CR.

The American Hospital Association also tells us

The House voted 220-205 today to pass legislation to hold employer-based health plans more accountable for improper denials of mental health and substance use benefits. The Mental Health Matters Act (H.R.7780) would give the Department of Labor more authority to enforce plan requirements under the Mental Health Parity and Addiction Equity Act and Employee Retirement Income Security Act, ban forced arbitration agreements when plans improperly deny benefits and ensure a fair standard of review by the courts. The bill also would provide grants to develop, recruit and retain school-based mental health professionals and link schools with local mental health systems, among other provisions.

Fierce Healthcare provides more color on this troubling bill.

The ERISA Industry Committee (ERIC)—which represents large employer plan sponsors—wrote a letter Monday to all House members calling for them to oppose (PDF) the Mental Health Matters Act when it comes up for a vote later this week. The letter comes as Congress is considering how to improve pay parity between behavioral and physical health amid reports of some insurers not following requirements in the Affordable Care Act. 

“This bill includes provisions that weaponize the Department of Labor (DOL) to sue employers rather than helping them come into compliance,” the letter said. * * *

[I]t remains unclear whether the Senate will take it up. The Senate Finance Committee is considering action to tackle pay parity but so far has not released any legislation. Chairman Ron Wyden, D-Oregon, previously told Fierce Healthcare that he is still working on legislation to tackle the issue, including taking aim at “ghost networks” where providers listed in directories don’t take new patients.

Earlier this month, Healthcare Dive reported that

The Senate Finance Committee released a bipartisan-supported discussion draft bill that aims to increase mental health access and improve mental health workforce shortages.

The draft bill proposes to fill the gap in mental healthcare worker shortages by funding training for 400 additional Medicare Graduate Medical Education psychiatric slots for residencies per year beginning Oct. 1, 2024. Over a decade, 4,000 psychiatric residencies would be supported by the funding, according to the bill.

The Senate’s focus on access to care makes much more sense than the House’s punitive approach, particularly considering the unnecessary complexity of the federal mental health parity law.

From the Omicron and siblings front, MedPage Today discusses nasally administered Covid vaccines now under development. “The idea is that mucosal vaccines could bolster immunity at these viral entry points, stopping the pathogen from implanting, multiplying, and transporting itself throughout the body.” Finger crossed.

From the monkeypox front, CNBC reports

A single dose of the two-dose monkeypox vaccine provides some protection against the virus, according to CDC data.

People at risk of monkeypox who have not received a shot are 14 times more likely to get infected, the preliminary data found.

These are the first real-world findings on how well the vaccine is working in the current outbreak.

 The CDC is still recommending that everyone at risk receive two doses of the vaccine.

From the Food and Drug Administration front —

STAT News informs us

The Food and Drug Administration approved a new medicine for ALS from Amylyx Pharmaceuticals on Thursday, providing a desperately-needed new treatment option for a devastating disease.

The medicine, to be sold as Relyvrio, is not a cure for ALS but proved to moderately slow the progression of the neurological disease, which causes the destruction of neurons in the brain and spinal cord, resulting in weakened muscles, paralysis, and death.

Amylyx did not immediately disclose how much it will charge for Relyvrio. “Amylyx’s goal is that every person who is eligible for Relyvrio will have access as quickly and efficiently as possible,” the company’s co-CEOs said in a statement, “as we know people with ALS and their families have no time to wait.”

Healio relates

The FDA approved bevacizumab-adcd for the treatment of six cancer types, according to a press release from the biosimilar’s manufacturer.

Bevacizumab-adcd (Vegzelma, Celltrion USA), a biosimilar to bevacizumab (Avastin, Genentech), is a recombinant humanized monoclonal antibody that binds to vascular endothelial growth factor (VEGF) and prohibits it from binding to VEGFR-1 and VEGFR-2 on the surface of endothelial cells.

FDA approved bevacizumab-adcd for metastatic colorectal cancer; recurrent or metastatic nonsquamous non-small cell lung cancer; metastatic renal cell carcinoma; recurrent glioblastoma; persistent, recurrent or metastatic cervical cancer; and epithelial ovarian, fallopian tube or primary peritoneal cancer.

In medical research news, STAT News tells us

After a steep drop in its stock price and with mounting competition from rivals, genomics giant Illumina on Thursday launched a new line of high-powered DNA sequencers, ratcheting up the race to read genetic information accurately and cheaply.

The new instruments, dubbed the NovaSeq X Series, can churn out up to 20,000 human genomes in a year, 2.5 times the max output of the company’s current machines, executives announced. The cost of generating this data has dropped, too, from about $5 per billion DNA bases on Illumina’s last line of high-end sequencers to as low as $2 on the new products.

That will bring the cost of reading a whole human genome on the company’s equipment from about $600 to $200, which could help make sequencing more mainstream in everyday medicine. While the price of sequencing isn’t the only obstacle to using genomics to improve human health, it remains a major factor.

Intriguing.

From the Medicare front, the Centers for Medicare and Medicaid Services (CMS) announced 2023 Medicare Advantage plan and Part D prescription drug plan premiums in advance of the Medicare Open Enrollment, which runs from October 15 through December 7, 2022.

The projected average premium for 2023 Medicare Advantage plans is $18 per month, a decline of nearly 8% from the 2022 average premium of $19.52. Medicare Advantage plans will continue to offer a wide range of supplemental benefits in 2023, including eyewear, hearing aids, preventive and comprehensive dental benefits, access to meals (for a limited duration), over-the-counter items, and fitness benefits.

[T]he average basic monthly premium for standard Part D coverage is projected to be $31.50, compared to $32.08 in 2022. 

To view the premiums and costs of 2023 Medicare Advantage and Part D plans, please visit: https://www.cms.gov/medicare/prescription-drug-coverage/prescriptiondrugcovgenin. Select the various 2023 landscape source files in the downloads section of the webpage. 

For state-by-state information, important dates and enrollment resources for Medicare Advantage and Part D in 2023, please visit: https://www.cms.gov/files/document/2023-medicare-advantage-and-part-d-state-state-fact-sheets.pdf

For more information on the Medicare Advantage Value-Based Insurance Design Model, including plan participation, please visit: https://innovation.cms.gov/innovation-models/vbid.

From the telehealth front, the Wall Street Journal reports a tragic story —

Cerebral treated a 17-Year-Old without His parents’ consent. They found out the day he died.
Telehealth startup didn’t use software to flag minors, according to employees and documents; company says it complies with state rules and the case is an outlier.

Anthony Kroll signed up for Cerebral in December and uploaded his Missouri intermediate driver’s license showing he was 17. Missouri law prohibits clinicians from providing mental-health treatment to people under 18 without parental consent. 

Anthony told a Cerebral clinician he had suicidal thoughts, and she prescribed him an antidepressant that carries a warning label for adolescents, according to medical records reviewed by the Journal. Cerebral didn’t notify his family. 

His parents, Wendi and Todd Kroll, said they didn’t know their son was suicidal or was seeking mental-health treatment. “I had no idea he was even on [medication] until the day he died,” Mrs. Kroll said, adding that she found the pill bottle at their home a few hours before her son died by suicide.

A Cerebral spokesman said Anthony misrepresented his age, the company regrets he received care without parental consent, and the treatment he received was appropriate. “This case is an unfortunate outlier,” the spokesman said. “Any loss of life is tragic, and we extend our deepest condolences to the family.” 

From the miscellany department

  • The GAO released a report titled “Artificial Intelligence in Health Care: Benefits and Challenges of Machine Learning Technologies for Medical Diagnostics.” ” Machine learning technologies can help identify hidden or complex patterns in diagnostic data to detect diseases earlier and improve treatments. We identified such technologies in use and development, including some that improve their own accuracy by learning from new data. But developing and adopting these technologies has challenges, such as the need to demonstrate real-world performance in diverse clinical settings.”
  • Federal News Network tells us

Agencies may soon get some more specific guidance on how best to implement President Joe Biden’s sweeping executive order on diversity, equity, inclusion and accessibility in the federal workforce.

The Chief Diversity Officers Executive Council, a governmentwide panel composed of agencies’ chief diversity officers and led by the Office of Personnel Management, held its first-ever meeting on Sept. 29.

“This has been a really long time coming,” OPM Director Kiran Ahuja said in an exclusive interview with Federal News Network.

Midweek update

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

From Capitol Hill, the Hill catches us up on the news surrounding the continuing resolution funding the federal government through December 16. The CR remains on track to be signed into law by the weekend. Here are links to the Senate Appropriations Committees’ text of the continuing resolution, which is a substitute for HR and a section-by-section bill summary.

From the Omicron and siblings front, David Leonhardt, writing in his Morning column for the New York Times, answers current questions about Covid vaccinations and boosters.

From the Rx coverage front, Fierce Pharma reports

Japanese ophthalmology specialist Santen has earned an FDA approval for its eye drops. The U.S. regulator has signed off on Santen’s Omlonti to reduce elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. Santen developed the drug, otherwise known as omidenepag isopropyl ophthalmic solution, along with another century-old Japanese firm, UBE Industries of Tokyo.

As a selective prostaglandin EP2 receptor agonist, Omlonti provides patients with primary open-angle glaucoma or ocular hypertension—both of which can cause blindness—a treatment with a unique mechanism of action, Santen said. 

“This approval is an important milestone in our ambition to tackle unmet needs in eye health,” Peter Sallstig, the chief medical officer of Santen, said in a release.

Known as Eybelis in Japan, the drops won approval there in 2018. On top of that, five more countries in Asia sanctioned the treatment last year. It is Santen’s first glaucoma offering in the U.S. Approximately 3 million people in the U.S. and 76 million worldwide have the two conditions, with numbers increasing as the global population ages, Santen said.

In other FDA developments, the agency today announced

proposed updated criteria for when foods can be labeled with the nutrient content claim “healthy” on their packaging. This proposed rule would align the definition of the “healthy” claim with current nutrition science, the updated Nutrition Facts label and the current Dietary Guidelines for Americans. 

More than 80% of people in the U.S. aren’t eating enough vegetables, fruit and dairy. And most people consume too much added sugars, saturated fat and sodium. The proposed rule is part of the agency’s ongoing commitment to helping consumers improve nutrition and dietary patterns to help reduce the burden of chronic disease and advance health equity. 

From the healthcare technology front, Fierce Healthcare tells us

Cigna is launching a new concierge care platform that aims to harness both the strengths of its health plan and its sister company, Evernorth.

The new offering, called Pathwell, integrates Evernorth’s data analytics, clinical expertise and digital solutions with the medical benefits and network of its health plan with the goal of providing a personalized, comprehensive care experience for members who are managing high-cost conditions. Pathwell will first target patients with musculoskeletal conditions and patients who take injectable or infused biologic drugs.

The Cigna team expects to build Pathwell out to other conditions in the future. The solution is now available in many U.S. commercial plans and will grow over the course of 2023.

Shawna Dodds, vice president of product development at Cigna, told Fierce Healthcare that combining the powers of the health plan and Evernorth allows the insurer to offer the choices members need to take charge of managing their own conditions.

“It’s combining the strategic assets that exist across those two companies to really bring the integrated experience to the consumer,” she said.

From the drug research front, STAT News warns that the positive trial results on Biogen’s new Alzheimer’s drug are not a reason by itself to pop the Champagne bottles.

The trumpeting from the companies Eisai and Biogen relied on data that showed that people receiving the therapy, lecanemab, saw a slower decline versus those on a placebo. That finding was based on a .45-point difference between the groups on an 18-point scale called the Clinical Dementia Rating sum of boxes, amounting to a 27% reduction in the rate of cognitive decline.

But translating what that statistical gobbledygook could mean for patients living with Alzheimer’s is a different challenge, one that physicians will have to navigate as they weigh whether to prescribe the treatment (presuming it wins regulatory approval) and for which patients.

The clinical significance of the trial data — as opposed to the statistical significance, which was proven by the study — will continue to be debated among neurologists and geriatricians as lecanemab moves through the regulatory approval process and into doctors’ offices. Insurers could also weigh in, assessing how widely they’re willing to cover the treatment and for which patients based on what kind of perceptible outcomes they think the data point to.

After all, what people want from any Alzheimer’s therapy is not measured by some “sum of boxes” or questionnaire but by the details of an individual life. Would this mean they could keep driving or working? Could they keep taking the dog for a walk without their family worrying about them getting lost? Could they hold on to the knowledge of who those family members are — and who they themselves are — for longer?

Mia Yang, a geriatrician at Wake Forest, noted that the impact of a .45-point difference on the scale depended on where someone was. Someone with a CDR score of 0.5, for example, might have some memory problems but could still keep up with daily activities. Someone with a score of 1, however, might start encountering some functional losses.

A half-point difference wouldn’t mean much for someone with more advanced Alzheimer’s, Yang said.

“I’m cautiously optimistic that it could be potentially meaningful for those folks who are in the mild stage,” Yang said about lecanemab. Indeed, the trial focused on people with early-stage Alzheimer’s.

From the US healthcare business front, Beckers Hospital CFO Report explores why nine hospitals closed this year. “From cash flow and staffing challenges to dwindling patient volumes, many factors lead hospitals to shut down.”

From the federal employee benefits front, Reg Jones, writing in Fedweek, discusses the Federal Employee Group Life Insurance Program known as FEGLI.

Monday Roundup

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

Federal News Network reports that its popular journalist on federal employment matters, Mike Causey, passed away at age 82 shortly after completing a broadcast.

Causey was a popular figure in the newsroom, who loved to share a funny story or joke, often approaching with a mischievous gleam in his eye. Colleagues appreciated his soft-spokenness and gentle demeanor. “Mike was someone who offered kindness and a warm smile to everyone he encountered,” said federal workforce reporter Drew Friedman.

A peerless reporter, Causey cultivated a large and devoted readership that followed him from medium to medium. He knew nuances of topics such as the best day to retire or the shrewdest Thrift Savings Plan strategy better than anyone. His writing was marked by an easy, accessible, occasionally humorous style undergirded by thorough, factual reporting. Causey is widely acknowledged as having coined the term, “inside the beltway.”

Now there’s a phrase that the FEHBlog frequently used without knowing its connection to Mike Causey. RIP.

Fierce Healthcare released its list of the most influential minority executives in healthcare for 2022. Congratulations to the winners.

From the healthcare cost front —

  • The Segal Company released its 2023 Health Care Costs Survey. “Health care spending in 2021 spiked an average of 14% per covered participant, the highest increase in a decade. The surge was primarily driven by the return of previously deferred medical care and the uptick of COVID-19 vaccines and therapeutics, according to data released” by Segal in this survey.
  • RevCycle Intelligence informs us “Inflation and rising labor costs will increase US national healthcare spending by $370 billion in the next five years, according to a McKinsey report. Consumer prices are rising faster than healthcare inflation, but general inflation has recently driven up healthcare supply input costs.”

Whoa, Nelly, the FEHBlog sees a common theme here. The cost curve is up.

From the Omicron and siblings front, WebMD tells us

Pfizer/BioNTech and Moderna, the two biggest COVID vaccine makers for the United States, are both seeking emergency authorization from the FDA for bivalent vaccine boosters for children.

Pfizer’s booster would be for children 5 to 11 who have completed a primary vaccination series, the company said in a Monday news release. Moderna’s updated boosters would be for children ages 6 to 17 who have completed a primary vaccination series, the company tweeted on Friday. 

For the Moderna booster, children 12 to 17 would receive the same dose as older people, while children 6 to 11 would get a half dose from the same vial, the CDC said in a Sept. 20 update to its fall vaccination planning guide.

“If authorized by FDA, CDC anticipates a recommendation for bivalent COVID-19 vaccine as a booster for pediatric age groups in early to mid-October,” the CDC document said.

From the substance use disorder front, the Hill reports

President Biden on Friday announced that his administration would distribute $1.5 billion to states and territories, including tribal lands, to fund responses to opioid overdoses and support recovery.

The U.S. Department of Health and Human Services (HHS) will disseminate the funding through the Substance Abuse and Mental Health Services Administration’s (SAMHSA) State Opioid Response and Tribal Opioid Response grant programs as part of National Recovery Month. * * *

Along with the new funding, the Biden administration published new guidance to facilitate greater access to FDA-approved naloxone products, which treat opioid overdoses in emergency situations, and guidance for employers to create “Recovery-Ready Workplaces.”

Weekend update

David Ermer–ACA, Congress, COVID treatment, COVID-19, Rx coverage–
Photo by Dane Deaner on Unsplash

Happy New Year. Shanah Tovah.

The House of Representatives and the Senate are scheduled to be in session this week for Committee business and floor voting. Congress is set to go on an election break on September 30, the end of the federal fiscal year. Due to the incentive to get on the campaign trail, the FEHBlog expects Congress to wrap up by the end of next weekend a continuing resolution funding the federal government through December 16. The Senate version of the continuing resolution will be released tomorrow as negotiations are ongoing.

From the Omicron and siblings front, the Department of Health and Human Services announced how the federal government supports the Covid treatment market as its funding shifts to the private sector.

From the Rx coverage front, STAT News tells us

Brand-name drugmakers increased wholesale prices by 4.9% in the second quarter this year, up slightly from 4.4% a year ago. But when accounting for inflation, wholesale prices fell by 3.7%. Inflationary pressures are likely to push wholesale prices still higher, STAT writes, citing a new analysis. At the same time, net prices that health plans paid for medicines — after subtracting rebates, discounts, and fees — dropped by 0.8%, but after considering inflation, net prices actually fell 7.9% compared with 3.8% in this year’s first quarter. This was the largest quarterly decline in real terms seen by analysts at SSR Health, which conducted the analysis.

From the litigation front, Health Affairs Forefront provides helpful background on a September 7 decision from a Texas district federal court holding the Appointments clause of the U.S. Constitution bars the federal government from treating U.S Preventive Services Task Force recommendations as binding on health plans. The lawsuit also involves a Religious Freedom Restoration Act (“RFRA”)claim. The Court has reserved a ruling on appropriate remedies. The FEHBlog expects that the Appointments clause challenge will not survive appellate review but who knows what can happen with an RFRA claim. Another remaining issue is the plaintiffs’ challenge to the contraceptive mandate.

From the maternal care front, MedCity News informs us

Racial disparities in maternal health complications grew amid Covid-19, BCBS report finds
Pregnancy-related complications increased 9% between 2018 and 2020 among all women, but the rate of change is even more significant among women of color. The disparities exist regardless of having commercial insurance or Medicaid. * * *

The fact that racial disparities exist regardless of commercial insurance or Medicaid coverage suggests that the issues are due to broader health challenges, including underlying conditions, racial inequities and biases in the healthcare system, according to the report.

To combat these disparities, BCBS listed several actions players in the healthcare industry can take. This includes adding nurse-midwives and birthing centers to provider networks, expanding coverage for postpartum care to one year after giving birth and using value-based contracts for maternal health.

BCBS doesn’t just call on healthcare leaders to act, but the government as well. In the report, the payer urges Congress to pass the Congressional Black Maternal Health Caucus’ Momnibus package, which provides steps to improve health outcomes for pregnant women and mothers of color. BCBS also asks for states to extend Medicaid coverage from 60 days to a full year postpartum, an option provided through the American Rescue Plan Act.

One’s race or ethnicity should not determine how likely you are to suffer from pregnancy-related complications. We must address deep-rooted issues like implicit bias and systemic racism that cause these disparities in the first place,” [Dr. Adam] Myers said in a news release.