Thursday Miscellany

Federal employment benefits

Thursday Miscellany

David Ermer–Congress, COVID treatment, COVID vaccine mandate, COVID-19, Federal employment benefits, OPM, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington DC —

Fedweek reports on Postal Services Health Benefit Program developments. The headline is that OPM expects “lots of questions” about the new program, which will launch in 2025. The good news for OPM and everyone effect affected is that the law requires the Postal Service to stand up a PSHBP education program this summer, which includes PSHBP navigators similar to the approach taken with the ACA marketplace.

FedWeek also tells us that the U.S. Court of Appeals for the D.C. Circuit rejected on procedural grounds a federal employee challenge to the Biden Administration’s Covid vaccine mandate for federal employees. The mandate has been blocked by a preliminary injunction in another federal judicial circuit. In any event, the vaccine mandates will end on May 12, the day after the Covid public health emergencies end.

From Capital Hill –

Fierce Healthcare informs us

A key Senate committee advanced legislation to ban pharmacy benefit manager tactics, such as spread pricing and clawback fees, and heighten transparency of the industry. 

The Senate Commerce Committee passed the PBM Transparency Act of 2023 by a vote of 18 to 9 on Wednesday, advancing the reform legislation to the full Senate. Lawmakers said the legislation is meant to address a source of unfair and deceptive practices that increase drug prices. 

Senators Chuck Grassley (R Iowa) and Maggie Hanson (D NH) have “introduced the Healthy Moms and Babies Act to improve maternal and child health care. The United States has a maternal health crisis that particularly affects women of color and those living in rural America. The Healthy Moms and Babies Act would achieve its goal by

  • Coordinating and providing “whole-person” care, supporting outcome-focused and community-based prevention, and supporting stillbirth prevention activities and expanding the maternal health workforce.  
  • Modernizing maternal health care through telehealth to support women of color and women living in rural America. 
  • Reducing maternal mortality and high-risk pregnancies including C-section births, and improving our understanding of social determinants of health in pregnant and postpartum women.

STAT News relates

The future of Alzheimer’s treatments and coverage hung heavily over lawmakers’ Wednesday [March 22 Senate Finance Committee] hearing with Health and Human Services Secretary Xavier Becerra.

Dotted throughout the hearing room for Becerra’s testimony on the president’s proposed health care budget for 2024 were purple-clad advocates for Alzheimer’s disease treatments, who Democrats and Republicans alike acknowledged repeatedly throughout the hearing. But while senators from both parties pushed for speedy approvals and Medicare coverage of new drugs for the disease, they unsurprisingly diverged on how to manage the costs.

At the center of discussions was a controversial Medicare decision, last year, not to cover Biogen’s Aduhelm except through clinical trials, a decision later extended to Eisai’s Leqembi. The Food and Drug Administration approved both via the accelerated pathway, with limited data on either drug’s effectiveness. The drugmakers are required to follow up with more extensive data proving each medicine’s benefit.

CMS expects to revisit this Medicare decision publicly this summer.

Beckers Hospital Reviews highlights

For about an hour and a half on March 22, four pharmaceutical supply experts outlined ideas to lawmakers to reform the nation’s slippery access to critical drugs. 

The FDA reports 130 drugs are currently in shortage; the American Society of Health-System Pharmacists says there are 302. Recently, the availability of vital drugs for cancer patients and emergencies has shrunk, and the closure of a U.S. drugmaker could put more out of stock. 

The hearing waded through causes of shortages — including manufacturing delays and opaque supply data. Some members on the Senate Committee on Homeland Security and Governmental Affairs pushed back on some pitched solutions, such as changing FDA practices and working to control drug prices.

In 2022, the number of new drug shortages increased by 30 percent, according to a report released by the Senate Committee on Homeland Security and Governmental Affairs hours before the hearing began.

“Colleagues and other hospitals have asked me to respond to the never-ending game of drug shortage Whac-A-Mole,” Andrew Shuman, MD, chief of the clinical ethics service center for bioethics and social sciences in medicine for the University of Michigan Medical School in Ann Arbor, said during the hearing. 

The House Ways and Means Committee’s Health subcommittee held a hearing yesterday on healthcare costs. The American Hospital Association submitted  a letter to the subcommittee that “shared how rising labor and other costs for hospitals and health systems are exacerbating workforce shortages and delaying patient access to care.”

Looking forward, Mercer Consulting identifies innovation in cancer treatment and prevention as the next frontier and McKinsey and Co. explores the pharmacy of the future.

From the miscellany department —

  • Medscape reports
    • “Use of nirmatrelvir-ritonavir (Paxlovid) in older adults with risk factors for severe disease was associated with a roughly 25% lower risk of a post-COVID condition (PCC), a retrospective study of Veterans Affairs data showed.
    • “In the cohort of over 280,000 patients with a confirmed COVID case, 13% of those prescribed nirmatrelvir-ritonavir went on to develop a PCC over the following 6 months compared with 18% of those who were not prescribed the antiviral (relative risk [RR] 0.74, 95% CI 0.72-0.77), Ziyad Al-Aly, MD, of the VA St. Louis Health Care System in St. Louis, and colleagues reported.” Fehblog observation: Go Paxlovid!
  • Per Beckers Hospital Review
    • 42% of adults in the U.S. are living with obesity, meaning they have a body mass index of 30 or higher, according to an analysis from NORC at the University of Chicago. 
    • Researchers used 2013 to 2021 data from the CDC’s Behavioral Risk Factor Surveillance System to estimate obesity rates at the national and state level. To account for any reporting biases in the BMI measure, NORC adjusted BMI distribution to that of the National Health and Nutrition Examination Survey for corresponding time periods. NORC also created an interactive map to present its findings. 
    • The article lists estimated state obesity rates for 2019 to 2021, ranked from highest (Mississippi – 51%) to lowest (Colorado 34%). FEHBlog observation At least one-third of every state’s population is morbidly obese, and yet we wonder why the life expectancy of Americans is dropping.
  • Medscape notes
    • For women who are overdue for cervical cancer screening, mailing self-sampling kits for high-risk human papillomavirus (HPV) is a cost-effective means of increasing screening uptake, reveals an analysis of a large US trial.
    • The finding comes from a randomized trial in almost 20,000 women, which compared women who received a mailed HPV testing kit with those who did not. The results show that mailing was most cost-effective in women aged 50-64 years and in those who were only recently overdue for cervical screening.
    • The study was published by JAMA Network Open on March 22.
    • “These results support mailing HPV kits as an efficient outreach strategy for increasing screening rates in US health care systems,” say the authors, led by Rachel L. Winer, PhD, MPH, Department of Epidemiology, University of Washington School of Public Health, Seattle, Washington. (FEHBlog observation: Good idea.)

Friday Insights

David Ermer–Congress, COVID-19, Federal employment benefits, Medicare, No Surprises Act, OPM–

From the OPM front, Federal News Efforts lays out the OPM issues raised by the House Oversight Accountability Committee, including an FEHB improper payments issue.

The Federal Employees Health Benefits (FEHB) Program came under scrutiny during the committee hearing. Several members pointed to a report from the Government Accountability Office showing that OPM spends about $1 billion annually on ineligible FEHB members.

Without a monitoring mechanism to identify and remove ineligible members from FEHB, GAO said these costs will keep accruing.

“GAO’s report suggests OPM has been aware of this problem for years but has consistently failed to address it effectively. As GAO recounts, OPM acknowledged the possibility of a problem when it issued regulations in 2018 allowing agencies and participating insurers to request proof of eligibility for federal employees’ family members. OPM did not, however, actually require proof of eligibility,” Chairman James Comer (R-Ky.) said in a Jan. 23 letter to Ahuja.

In response to the concerns, Ahuja said during the hearing that OPM is working on creating a master enrollment index (MEI) — essentially a roster of FEHB subscribers and family members. The creation of an MEI has been in the works in OPM’s FEHB department for at least the last couple of years.

“We have been focused on this issue,” Ahuja said. “It’s a very decentralized health benefits program. We’ve been working with agencies and carriers to be able to ensure that we manage any ineligibility.”

Ahuja said the index will help clear up discrepancies in FEHB enrollment between both agencies and health carriers.

“That’s going to be a way forward,” she said.

With all due respect to the Director, the key problem is that OPM has never provided FEHB carriers with an enrollment roster that ties individuals to premiums paid for (and by) them. Until carriers can reconcile premiums with enrollment, the Master Enrollment Index remains flawed

HIPAA offers a widely used “820” electronic transaction standard for this purpose. In a perfect world, OPM would have rolled out the use of the 820 transactions to allow carriers to clean their enrollment records. It’s not too late, and doing so should be prioritized over the family member issue and centralization.

Family member eligibility is a secondary issue because 48% of FEHB enrollment is self-only, and the FEHB Program family member size averages under three people. The family member eligibility issue can be addressed with surveys based on statistical sampling rather than the entire enrollment of eligible family members.

The private sector uses the HIPAA 820, and randomized family member eligibility audits to keep enrollment records accurate.

From the CMS front, the American Hospital Association tells us that following up on U.S. District Judge Jeremy Kernodle’s February 6, 2023, revisions to the No Surprises Act’s (NSA) independent dispute resolution/arbitration rule:

The Centers for Medicare & Medicaid Services today instructed certified independent dispute resolution entities to resume making payment determinations for disputes involving items or services furnished on or after Oct. 25, 2022. Updated guidance to disputing parties regarding disputes involving items and services furnished on or after Oct. 25, 2022 is posted here. CMS also announced that starting March 17, disputing parties will begin receiving a majority of their payment determination notices from the IDR portal, specifically from auto-reply-federalidrquestions@cms.hhs.gov. Disputing parties are advised to make note of this email address.

The FEHBlog finds it mysterious that this guidance is coming from CMS when Medicare and Medicaid are exempt from the NSA.

In other CMS news

The Centers for Medicare & Medicaid Services will make whole health care providers impacted by lowered coinsurance on 27 Medicare Part B prescription drugs. The reduced coinsurance rates, which are required by the Inflation Reduction Act, take effect April 1 and will remain in effect through June 30. CMS in a fact sheet says it will pay impacted health care providers the difference between the full and reduced adjusted beneficiary coinsurance (in addition to their usual payment), after applying the Part B deductible and prior to sequestration, if applicable.

That’s good news because other FEHB and other plans providing secondary coverage would be picking up that cost.

In conference news, Fierce Healthcare discusses policy presentations from HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-Lasure at an AHIP conference and health and medtech presentations from the South by Southwest conference in Austin.

Also at the AHIP conference per MedCity News

Improving the mental health workforce shortage is one of the Substance Abuse and Mental Health Services Administration’s top priorities right now, said Miriam Delphin-Rittmon, assistant secretary for mental health and substance use at HHS and the administrator of SAMHSA. To tackle this, the organization has several resources and grant programs in place to recruit more providers and support primary care physicians in treating mental health. 

Each of these conferences was held this week.

From the public health front, CMS’s biweekly review of its Covid statistics tells us

As we mark three years of the COVID-19 pandemic, cases, deaths, and hospitalizations have all been decreasing steadily. Much of the U.S. population has some form of immunity, either through vaccination or previous infection. In addition, CDC’s 2023 Child and Adolescent Immunization Schedule now includes COVID-19 primary vaccine series and links to the latest guidance on booster dose vaccination in all populations.

The Wall Street Journal offers former CDC Director Tom Frieden view on the past three pandemic years.

The CDC’s Fluview continues to report “Seasonal influenza activity remains low nationally.”

The New York Times highlights a recent breakthrough in stroke treatment. The article reports that this breakthrough allowed John Fetterman to be a U.S. Senator from Pennsylvania. Here’s the catch.

There’s a number that floats around in medicine: It takes, on average, 17 years for a new treatment or technique, or some other form of research breakthrough, to filter down into widespread clinical practice. But the actual timeline varies widely from case to case. “What everybody’s trying to do is speed up that process,” says Dr. Sharon Straus, the director of the Knowledge Translation Program at St. Michael’s Hospital in Toronto. (“Knowledge translation” is one of several terms for a young, multidisciplinary field that aims to better understand and improve the medical research-to-practice pipeline.) “Some things do take off more quickly.”

That number of years is sobering. Good luck, Dr. Straus.

In FSAFeds news, the Internal Revenue Service issued FAQs addressing “whether certain costs related to nutrition, wellness, and general health are medical expenses under section 213 of the Internal Revenue Code (Code) that may be paid or reimbursed under a health savings account (HSA), health flexible spending arrangement (FSA), Archer medical savings account (Archer MSA), or health reimbursement arrangement (HRA).”

Thursday Miscellany

David Ermer–ACA, CDC, CMS, COVID treatment, COVID-19, COVID-19 testing, FDA, Federal employment benefits, Medicare, No Surprises Act, Patient safety, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

The Wall Street Journal reported this morning that maternal mortality cases in the U.S. spiked in 2021, rising from around 850 to 1200 nationwide. From examining Journal reader comments, the FEHBlog ran across a helpful breakdown of maternal deaths per U.S. state.  The lowest maternal death rate is in California, and the highest maternal death rate is in Louisiana.  The breakdown points out what the States with the lowest rates are doing right and what the States with the highest rates are doing to remedy the problem. Healthcare is local.

The FEHBlog also was directed to this article from the T.H. Chan public health school at Harvard:

October 21, 2022 – Women in the U.S. who are pregnant or who have recently given birth are more likely to be murdered than to die from obstetric causes—and these homicides are linked to a deadly mix of intimate partner violence and firearms, according to researchers from Harvard T.H. Chan School of Public Health.

Homicide deaths among pregnant women are more prevalent than deaths from hypertensive disorders, hemorrhage, or sepsis, wrote Rebecca Lawn, postdoctoral research fellow, and Karestan Koenen, professor of psychiatric epidemiology, in an October 19 editorial in the journal BMJ.

The U.S. has a higher prevalence of intimate partner violence than comparable countries, such violence is often fatal, and it frequently involves guns, Lawn and Koenen noted. They cited one study that found that, from 2009–2019, 68% of pregnancy-related homicides involved firearms. That study also found that Black women face substantially higher risk of being killed than white or Hispanic women.

I also located the CDC’s website on keeping new mothers alive.

This evening the Journal discussed why our country’s maternal mortality rate is so high.

Finally, STAT News reports that this afternoon the Centers for Disease Control announced preliminary 2022 maternal mortality figures.

Deaths of pregnant women in the U.S. fell in 2022, dropping significantly from a six-decade high during the pandemic, new data suggests.

More than 1,200 U.S. women died in 2021 during pregnancy or shortly after childbirth, according to a final tally released Thursday by the Centers for Disease Control and Prevention. In 2022, there were 733 maternal deaths, according to preliminary agency data, though the final number is likely to be higher.

Officials say the 2022 maternal death rate is on track to get close to pre-pandemic levels. But that’s not great: The rate before Covid-19 was the highest it had been in decades.

The CDC counts women who die while pregnant, during childbirth, and up to 42 days after birth. Excessive bleeding, blood vessel blockages, and infections are leading causes.

Covid-19 can be particularly dangerous to pregnant women, and experts believe it was the main reason for the 2021 spike. Burned out physicians may have added to the risk by ignoring pregnant women’s worries, some advocates said.

In 2021, there were about 33 maternal deaths for every 100,000 live births. The last time the government recorded a rate that high was 1964.

What happened “isn’t that hard to explain,” said Eugene Declercq, a long-time maternal mortality researcher at Boston University. “The surge was Covid-related.”

The FEHBlog’s goal is to provide perspective on this vital issue.

From the Omicron and siblings front, MedPage Today informs us

An FDA panel recommended the agency grant full approval to nirmatrelvir-ritonavir (Paxlovid) for treating high-risk COVID-19.

By a vote of 16-1 on Thursday, the Antimicrobial Drugs Advisory Committee said the totality of evidence supports the traditional approval of the oral antiviral, which has been widely used since late 2021 under an emergency use authorization to reduce the risk of hospitalization or death in outpatients at risk for severe outcomes.

“Besides oxygen, Paxlovid has probably been the single most important treatment tool in this epidemic, and it continues to be,” said Richard Murphy, MD, MPH, of the White River Junction VA Medical Center in Hartford, Vermont.

The Mercer consulting firm considers employer approaches to coverage of Covid tests following the end of the public health emergency.

Employers have some important decisions to make over the next two months before the COVID Public Health Emergency (PHE) comes to an end on May 11. One is how to handle cost-sharing for PCR and other COVID tests and related services provided by a licensed healthcare or otherwise authorized provider. Under the PHE, group health plans had to cover testing received either in- or out-of-network at no cost to participants. 

We recently polled recipients of our New Shape of Work newsletter to ask whether they planned to impose cost-sharing requirements once allowed. Of the more than 1,000 readers who responded, about half indicated that their organization will  not make any change when the PHE ends:  22% will continue to cover PCR testing at 100% both in- and out-of-network, and 29% say that they require COVID testing at their worksites and provide it at no cost.  Only about a fourth (26%) will now require cost-sharing from participants even when they use an in-network facility for testing; about another fourth (23%) will add a cost-sharing requirement only for out-of-network services.   

Personally, the FEHBlog would opt for restoring a cost-sharing requirement only for out-of-network services.

From the Rx coverage front

  • STAT News tells us, “Following the lead of its rivals, Sanofi will cut the price of its most widely prescribed insulin in the U.S. by 78% and also place a $35 cap on out-of-pocket costs for commercially insured patients who take the treatment, which is called Lantus. The moves will go into effect on Jan. 1, 2024.”
  • The Mercer consulting firm offers its perspective on coverage of the new era of weight loss drugs, e.g., Ozempic.

For plans covering weight-loss medications, adding prior authorization criteria can help manage cost growth. These include requirements such as a certain body mass index (BMI), co-morbid conditions, enrollment in a behavior modification program, and/or reduced calorie diet. Upon initiation of therapy, patients and clinicians should partner to create a comprehensive plan to achieve goals and use the medication purposefully alongside a targeted and managed lifestyle program. The plan should include a discussion regarding medication discontinuation when/if goals are met to prevent relapse and weight regain/ weight cycling. Medical nutrition therapy (MNT) with a registered dietitian should be covered; ideally 14 in-person or telenutrition sessions.

Cognitive-behavioral therapy, self-monitoring, motivational interviewing, structured meal plans, portion control and goal setting are recommended interventions. Ideally, patients would progress from dietary intervention (covered MNT or weight management solution), to weight loss medications, and then, potentially, to bariatric surgery.  

In recognition of Patient Safety Awareness Week, the Partnership to Fight Infectious Disease announced, making March 18 a day of action to raise awareness of the need to #squashsuperbugs so that we can all do our part to prepare and perhaps even prevent a future pandemic due to antibiotic resistance.

From the No Surprises Act front, Fierce Healthcare reports

An “astronomical” number of surprise billing arbitration dispute cases is impacting the Centers for Medicare & Medicaid Services (CMS), a top agency official said.

Education and communication are integral to an “orderly transition” in the handling of independent dispute resolutions for out-of-pocket charges, the official said. The agency has grappled with legal issues and implementation hiccups surrounding a controversial process for settling feuds between payers and providers on out-of-network charges.

“We are seeing more than expected number of disputes getting to that last stopgap part, which is the independent dispute resolution part,” said Ellen Montz, director of CMS’ Center for Consumer Information and Insurance Oversight. Montz spoke during a session Wednesday at the AHIP Medicare, Medicaid, Duals & Commercial Markets Forum in Washington, D.C. 

The agency is also seeing a lot of ineligible cases that don’t qualify for the dispute resolution process, which requires a third party to choose between out-of-network charges submitted by the payer and provider. 

These ineligible cases require “a lot of casework, phone calls and back and forth to determine eligibility,” Montz said. 

From the Medicare front, Healthcare Dive tells us

The group that advises Congress on Medicare policy is recommending updating base physician payment rates by 1.45% for 2024, according to its annual March report out Wednesday.

The Medicare Advisory Payment Commission, or MedPAC, did not make recommendations for ambulatory surgery center payment updates or for Medicare Advantage plans.

The commission did note concern with MA plan coding intensity, and said Medicare now spends more on MA enrollees than it would have spent had those enrollees remained in fee-for-service plans.

The FEHBlog doubts that this MedPAC report made anyone happy.

From the federal employee benefits front, FedWeek reminds folks that while the dependent care flexible spending accounts available to federal employees typically are used for child care, they also can be used for senior care in certain circumstances.

Midweek update

David Ermer–CMS, Federal employment benefits, Medicare, OPM, Rx coverage, U.S. Healthcare–

From the federal employment front, Govexec tells us

The Biden administration is looking to add 82,000 employees in fiscal 2024, a 3.6% increase that would bring civilian federal rolls to their highest levels since World War II. 

Nearly every federal agency would receive a funding boost in President Biden’s fiscal 2024 budget, and all but one major agency is anticipating adding staff as a result. Some of the hiring is still aimed at making up for losses sustained during Obama-era budget caps and Trump-era targeted reductions, though much of it is for implementing major new initiatives Biden has ushered into law like the Inflation Reduction Act and the bipartisan infrastructure measure Congress approved in 2021.

“As we release the President’s FY 2024 Budget, we are proud of the mission-driven investments it makes in the federal government’s most important asset—our people,” Office of Management and Budget Deputy Director for Management Jason Miller and Office of Personnel Management Director Kiran Ahuja said in a [Performance.gov] blog post Monday. 

From the end of the public health emergency front, Health Payer Intelligence reports

In most states, beneficiaries who lose Medicaid coverage when the public health emergency ends are likely to transition into employer-sponsored health plans, according to a study funded by AHIP from NORC at the University of Chicago (NORC).

NORC used the Urban Institute’s public health emergency Medicaid coverage loss estimates and historic data from the Current Population Survey (CPS) Annual Social and Economic Supplement (ASEC).

The researchers recategorized the data, taking into account respondents’ coverage type in year one and year two of the transition, supplementing data for smaller states, and applying a hierarchy of coverage types to distribute respondents with multiple coverage sources. When respondents had multiple coverage types, the researchers prioritized first employer-sponsored coverage, then uninsurance, CHIP, nongroup coverage, and other public coverage, respectively.

When the researchers blended these two data sources, the study found that individuals who lose their Medicaid coverage after the end of the public health emergency will transition into employer-sponsored health plans in most states.

More than half of the beneficiaries who lose Medicaid coverage will transition to employer-sponsored health plan coverage in every state except for Georgia (48.9 percent), according to the dashboard associated with the report. The state with the highest share of beneficiaries going into employer-sponsored health plans after the public health emergency was Delaware (57.1 percent).

Because FEHB-eligible annuitants and family members must be on Medicaid, OPM may want to consider sharing information with federal agencies about how this cohort can shift from Medicaid to FEHB and when to apply.

From the Medicare front —

  • CMS today trumpeted that Medicare Part D members can receive vaccinations without cost sharing. CMS doesn’t mention that commercial plans, including FEHB plans, have offered this opportunity under the Affordable Care Act since 2011. For example, the FEHBlog received a shingles vaccination with no-sharing (in-network) before he went on Medicare (because his company has under 20 employees). He got hit with a $400 Medicare Part D copay when he received the updated shingles shots in 2019. Better late than never because the FEHBlog needs a TDap booster next year.
    • While Congress emptied this bowl of wrong, Medicare beneficiaries still face a pre-existing condition limitation (except in certain states) if they try to enroll in a Medicare supplement plan after the first opportunity.
  • CMS announced “27 prescription drugs for which Part B beneficiary coinsurances may be lower from April 1 – June 30, 2023. Thanks to President Biden’s new law to lower prescription drug costs, some people with Medicare who take these drugs may save between $2 and $390 per average dose starting April 1, depending on their individual coverage.” One CMS fact sheet explains how this program works, and another CMS fact sheet lists the 27 drugs, which include Humira. This will reduce FEHB Program spending as a secondary payer for annuitant and eligible family members with primary Part B. In the FEHBlog’s opinion, this program will not generate a dollar-for-dollar cost shift from Medicare to the FEHB cohort without primary Part B due to how the new program is structured.
  • Looking forward, CMS released its “Initial Guidance for Historic Medicare Drug Price Negotiation Program for Price Applicability Year 2026.” Thanks to OPM’s decision to allow FEHB plans to offer Part D EGWPs in 2024, the FEHB will be advantaged by the Part D savings.

From the public health front, the Alzheimers Association issued

Alzheimer’s Disease Facts and Figures, an annual report released by the Alzheimer’s Association, reveals the burden of Alzheimer’s and dementia on individuals, caregivers, government and the nation’s health care system.

The accompanying special report, The Patient Journey in an Era of New Treatments, examines the importance of conversations about memory at the earliest point of concern, as well as a knowledgeable, accessible care team to diagnose, monitor disease progression and treat when appropriate. This is especially true now, in an era when treatments that change the underlying biology of Alzheimer’s are available.

From the miscellany department –

  • Forbes informs us that “the U.S. government is suing Rite Aid — accusing the drugstore chain of “knowingly” filling unlawful prescriptions for controlled substances — only adds to the financial and operational woes of the embattled drugstore chain.”
  • AHIP has added details to the March 29-30 OPM AHIP FEHB Carrier Conference agenda.
  • The Wall Street Journal reports on yesterday’s abortion pill hearing before a federal judge in Amarillo, Texas. “A federal judge on Wednesday questioned the government about its approval of a medication used in more than half of the abortions in the U.S. but also asked whether there was any precedent for a court blocking sales of a drug long after it had been allowed on the market.” The FEHBlog expects the Court to rule in the federal government’s favor because no such precedent exists.  
  • Beckers Hospital Review tells us

A ChatGPT update released March 14 has been stunning physicians with its ability to deliver sound medical advice, The New York Times reported.

Anil Gehi, MD, a cardiologist and associate professor of medicine at Chapel Hill, N.C.-based UNC Health, described the health history of a patient, using advanced medical terminology, to the artificial intelligence chatbot and asked it how he should treat the person, according to the March 14 story.

“That is exactly how we treated the patient,” he said of ChatGPT’s answer.

Experts told the newspaper the new GPT-4 technology is more precise, accurate and descriptive than its predecessor, which OpenAI released in November. However, the chatbot is still prone to “hallucination” and making things up.

Monday Roundup

David Ermer–AHRQ, CMS, Congress, COVID-19, FDA, Federal employment benefits, OPM, Patient safety, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From our Nation’s capital, OPM released its Fiscal Year 2024 Congressional Budget Justification document, which is part of the federal budget process. Of interest to the FEHBlog is this OPM goal:

Improve customer experience by making it easier for Federal employees, annuitants, and other eligible persons to make a more informed health insurance plan selection. 

By September 30, 2023, complete user-centered design and develop a minimum viable product for a new, state-of-the-art Decision Support Tool that will give eligible individuals the necessary information to compare plan benefits, provider networks, prescription costs, and other health information important to them and their families.

Federal News Network tells us about a related Office of Management and Budget analytical perspective on federal workforce issues.

The Office of Management and Budget, in one of its analytical perspectives supplementing the Biden administration’s 2024 budget request, said federal workers’ pay is “increasingly hamstrung” by statutory requirements “that curb the ability of agencies to reward talent, including for specialized occupations, in a national competitive job environment.”

From the Rx coverage front —

The Wall Street Street Journal reports

Eisai Co.’s new Alzheimer’s disease drug Leqembi will be covered by the U.S. Department of Veterans Affairs, the first major insurer to agree to pay for the drug since its approval by U.S. regulators earlier this year. 

Eisai said Monday veterans with the early stages of Alzheimer’s would get the drug covered under criteria set by the VA.

An estimated 167,954 veterans receiving care through the VA have Alzheimer’s dementia, according to government estimates. To qualify for Leqembi, patients must be over 65, have early-stage symptoms and elevated brain amyloid, sticky protein fragments, which the drug is designed to remove.

STAT News describes the VA’s step as “unexpected,” which is an understatement because CMS does not plan to issue a Medicare national coverage decision until mid-year. STAT News adds

The [VA] published a guide on its formulary saying coverage will extend to any veteran who meets specified criteria, including an MRI scan within the previous year, amyloid PET imaging consistent with Alzheimer’s and a staging test indicating mild Alzheimer’s dementia. There is also a long list of criteria that would exclude veterans.

The agency can negotiate prices for drugs, but the price it will pay for Leqembi was not listed and the Eisai spokesperson did not offer a cost. Leqembi has an annual wholesale price of $26,500, although the Institute for Clinical and Economic Review recently said the treatment should cost between $8,900 and $21,500 per year to be considered cost effective.

Under federal law, the VA can bill other health plans (including FEHB but not Medicare) for non-service related care such as this drug. For this reason, this VA action opens the back door to FEHB coverage of Leqembi.

From the end of the public health emergency front —

The Society for Human Resource Management offers its take on how employers should prepare for the end of the PHE, now less than two months away.

The American Hospital Association points out

The Food and Drug Administration will end 22 COVID-19-related policies when the public health emergency ends May 11 and allow 22 to continue for 180 days, including temporary policies for outsourcing facilities compounding certain drugs for hospitalized patients and non-standard personal protective equipment practices for sterile compounders not registered as outsourcing facilities, the agency announced. FDA plans to retain 24 COVID-19-related policies with “appropriate changes” and four whose duration is not tied to the PHE, including its recently revised policy for COVID-19 tests. 

From the Rx business front —

BioPharma Dive informs us

Pfizer has agreed to buy Seattle-based Seagen for $43 billion in a blockbuster deal that would unite the pharmaceutical giant with a biotechnology company that pioneered a new type of tumor-killing medicine.

The acquisition is the largest Pfizer has attempted since its 2009 purchase of Wyeth, and is the most sizable in the drug industry by value since AbbVie’s $63 billion buyout of Allergan in 2019.

Acquiring Seagen gives Pfizer control of the top-selling lymphoma medicine Adcetris as well as a pipeline of cancer treatments that’s yielded three new drug approvals in the past three years. Seagen specializes in a type of cancer therapy known as an antibody-drug conjugate, and has steadily improved on the technology since its founding in 1997.

STAT News relates

Sanofi said Monday that it is acquiring Provention Bio, makers of a diabetes treatment, for $2.9 billion.

The Provention drug at the centerpiece of the deal, called TZield, was approved in the U.S. last November as the first and only treatment to prevent the onset of symptomatic Type 1 diabetes. Sanofi was already co-marketing the drug under a prior licensing deal signed between the two companies.

The French pharma giant will now own TZield outright, paying $25 per share to acquire Provention — a 273% premium over Friday’s closing stock price.

In recognition of Patient Safety Awareness Week

  • The HHS Agency for Healthcare Quality and Research’s Director Robert O. Valdez, Ph.D., M.H.S.A. explains how AHRQ is sharpening its focus on diagnostic safety.
  • Beckers Hospital Review reports
    • The pediatric mental health crisis is the most pressing patient safety concern in 2023, the Emergency Care Research Institute said on March 13. 
    • The ECRI, which conducts independent medical device evaluations, annually compiles scientific literature and patient safety events, concerns reported to or investigated by the organization, and other data sources to create its top 10 list.
    • Here are the 10 patient safety concerns for 2023, according to the report: 
      • 1. The pediatric mental health crisis
      • 2. Physical and verbal violence against healthcare staff
      • 3. Clinician needs in times of uncertainty surrounding maternal-fetal medicine
      • 4. Impact on clinicians expected to work outside their scope of practice and competencies
      • 5. Delayed identification and treatment of sepsis
      • 6. Consequences of poor care coordination for patients with complex medical conditions
      • 7. Risks of not looking beyond the “five rights” to achieve medication safety
      • 8. Medication errors resulting from inaccurate patient medication lists
      • 9. Accidental administration of neuromuscular blocking agents
      • 10. Preventable harm due to omitted care or treatment
  • The U.S. Department of Labor announced on March 10
    • the launch of a series of online dialogues to gather ideas and other public input on how health policies can support workers’ mental health most effectively.
    • The crowdsourcing will focus on four areas of concern for people with mental health conditions, including benefits policies that meet their needs, access to workplace care and supports, the reduction of related social stigmas, disparities faced by people in underserved communities, shortages of behavioral health professionals, and the establishment of state resource systems.
    • Part of the department’s ePolicyWorks initiative, the dialogues will remain open until April 3. Input received will inform the next meeting of the Mental Health Matters: National Task Force on Workforce Mental Health Policy
  • Healthexec calls attention to FDA recalls of certain eyedrops.

From the value-based care front, Health Payer Intelligence notes

CareFirst BlueCross BlueShield (CareFirst) has formed a strategic alliance with Aledade, Inc. (Aledade), offering independent primary care physicians tools and resources to improve healthcare affordability and effectiveness, supporting CareFirst member physicians in achieving value-based care goals.

Through this value-based relationship, CareFirst member physicians can leverage specialists, including onsite business support for physician practices, a technology platform that works with more than 100 different EHRs, and healthcare regulatory and policy expertise.

From the medical debt front, Healthcare Dive reports

  • Hospitals are a prime source of medical debt in America that hits underserved populations hardest, despite charity care programs and financial assistance policies, according to a new analysis from the Robert Wood Johnson Foundation.
  • Of the 15% of U.S. adults with past-due medical debt, almost two-thirds owe some or all of that debt to hospitals, according to research from the Urban Institute. That medical debt disproportionately affects underserved populations, such as low-income individuals and people with disabilities, researchers found.
  • While medical debt remains a persistent financial burden in the U.S., a new analysis from the Urban Institute highlights how targeting hospital billing could ameliorate the problem.

Happy International Women’s Day

David Ermer–CDC, FDA, Federal employment benefits, Medicare, Mental health care, No Surprises Act, OPM, Rx coverage, SDOH, U.S. Healthcare–
Photo by Hannah Busing on Unsplash

The Wall Street Journal reports

American women are staging a return to the workforce that is helping propel the economy in the face of high inflation and rising interest rates.

Women have gained more jobs than men for four straight months, including in January’s hiring surge, pushing them to hold more than 49.8% of all nonfarm jobs. Female workers last edged higher than men on U.S. payrolls in late 2019, before the pandemic sent nearly 12 million women out of jobs, compared with 10 million men. 

The Society for Human Resource Management offers five ways employers can reduce gender disparities at work.

Following up on recent posts —

  • The Wall Street Journal brings us up to date on Lilly’s decision to offer its insulin products on the commercial market with a $35 copayment.
    • “Lilly comes out the winner of this saga, for now. It dealt PBMs a blow, avoided paying Medicaid rebates that were going to rise next year if its insulin products remained highly-priced, and received plaudits from President Biden. The move also complicates matters for upstarts such as Civica. But Allan Coukell, Civica’s senior vice president of public policy, says plans to introduce low-cost insulin as soon as next year are unchanged.”
  • Bloomberg offers an article on biological age testing that mentions Elysium Health, whose CEO spoke at the WSJ Health Forum on Monday.
  • Beckers Hospital Review tells us that the Amoxicillin shortage is continuing. Because Amoxicillin is one of several drug shortages, Pharma News Intelligence offers short-term and long-term management strategies to deal with them.
  • STAT News reports
    • Last week, the Food and Drug Administration issued an emergency authorization for the first at-home Covid-19 and flu combination test. The news came just days after the test’s maker, Lucira, filed for bankruptcy, blaming the FDA’s “protracted” approval process for its financial problems.
    • “Now the FDA has released a rare comment clarifying what happened during its authorization process. The new details are raising hopes among other home-test manufacturers that the FDA is becoming more flexible about its requirements for approving at-home flu test kits.”
  • Beckers Payer Issues informs us,” Providers join payers in urging CMS to halt proposed 2024 Medicare Advantage rates.” Good news for AHIP. Healthcare Dive reviews insurer and trade association comments to CMS on this topic.
  • The Wall Street Journal highlights the growing backlog of No Surprises Act arbitrations. The silver lining in this cloud is that the litigation-related backup does not impact the law’s Open Negotiation Process. Providers and payers should work to resolve qualifying payment disputes through that effective process.

In other news

  • JAMA points out a recent CDC report documenting disparities in mental health-related emergency department care.
  • The Drug Channels blog lists the 15 largest U.S. pharmacies. (Trigger warning the link is principally a sales pitch for Drug Channels, but the information is useful.)
  • MedTech Dive informs us
    • “Abbott received U.S. Food and Drug Administration clearance for what it said will be the first commercially available laboratory blood test to help evaluate traumatic brain injury (TBI), also known as concussion.
    • “The test offers a result in 18 minutes, allowing clinicians to quickly assess patients with concussion and triage them, the company said Tuesday. A negative test result can rule out the need for a CT scan, eliminating wait time at the hospital.
    • “The test runs on Abbott’s Alinity i laboratory instrument, making it widely available to U.S. hospitals, the Chicago area-based company said.”
  • NPR discusses efforts to right various healthcare debt collection wrongs:
    • “Dozens of advocates for patients and consumers, citing widespread harm caused by medical debt, are pushing the Biden administration to take more aggressive steps to protect Americans from medical bills and debt collectors.
    • “In letters to the IRS and the Consumer Financial Protection Bureau, the groups call for new federal rules that, among other things, would prohibit debt for medically necessary care from appearing on consumer credit reports.
    • “Advocates also want the federal government to bar nonprofit hospitals from selling patient debt or denying medical care to people with past-due bills, practices that remain widespread across the U.S., KHN found.
    • “And the groups are pressing the IRS to crack down on nonprofit hospital systems that withhold financial assistance from low-income patients or make getting aid cumbersome, another common obstacle KHN documented.”

FEHBlog message to Congress

  • FEDWeek reports
    • The House Oversight and Accountability Committee has started an investigation into the role of “pharmacy benefit managers” (PBMs), which act as a middleman between insurance carriers and pharmaceutical companies in healthcare programs, including the FEHB.
    • “Greater transparency in the PBM industry is vital to determine the impact PBM tactics are having on patients and the pharmaceutical market,” chairman Rep. James Comer, R-Ky., wrote to OPM. He asked for copies of the PBM contracts in the program and information on how they are carried out, as well as for information on the rebates, fees, or other similar charges received by PBMs and any efforts the agency has made to recoup overpayments to them.”
    • “The use of pharmacy benefit managers has been a long-running issue in the FEHB, with prior proposals—mainly sponsored by Democrats, unsuccessfully—to limit their role or even have OPM negotiate with pharmaceutical companies directly on a program-wide basis.
    • “The inspector general’s office at OPM also has raised that issue, in a recent report saying that “the discounts and other financial terms differed significantly among carriers, with those that have higher enrollments receiving the best deals, reducing the likelihood that the FEHB is maximizing prescription drug savings.” 
    • “That report recommended that OPM conduct a study on options to hold down prescription drug costs, which account for a quarter of all spending in the FEHB. OPM agreed in principle, although it said it does not have the needed funds to conduct such a study.”
  • OPM should inform Rep. Comer that
    • The FEHB Program’s experience-rated carriers, who cover 80% of the FEHB enrollment, are subject to the country’s strictest PBM price transparency arrangement, as far as the FEHBlog knows. Congress should evaluate that system to help the legislative body decide whether transparency should be expanded to ERISA and ACA marketplace plans.
    • In the late 2010s, OPM announced in a management report that the agency agreed with carriers that the FEHB Program saves money by allowing carriers to manage medical and pharmacy benefits under OPM’s oversight. FEHB plan carrier HealthPartners offers a useful examination of carve-in vs. carve-out Rx program management topics.
    • OPM has authorized FEHB carriers to offer prescription drug plans integrated with Medicare Part D beginning in 2024. This change will rapidly reduce the FEHB Program’s prescription drug spend to commercial plan levels. It’s not magic.
    • In sum, the FEHB Program remains a model employer-sponsored health program.

Friday Factoids

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

Here are links to the CDC’s Covid Data Tracker and its last weekly interpretative review of those statistics. From now until the interpretative review ends, the interpretative review will be offered every other week, except when that Friday is the beginning of a federal three-day weekend. Good timing for this change because we just started the three-day weekend drought, which ends with Memorial Day.

The summary notes, “At this point in the pandemic, COVID-19 cases, hospitalizations, and deaths have been decreasing for several weeks, and much of the country has protection against circulating strains either through vaccination, previous infection, or a combination of both.” Nevertheless, the CDC urges folks to be vaccinated or stay current on vaccinations because the virus can change.

The CDC’s Fluview says, “Seasonal influenza activity remains low nationally.”

From the Rx coverage, Ed Silverman writing in STAT News comments

Now that Eli Lilly slashed the price for some of its insulin products, the moves raised questions about what will happen to other efforts to provide low-cost insulin, Kaiser Health News explains. Civica, a nonprofit, plans to begin selling biosimilar insulin for roughly $30 per vial by 2024 — $5 more than the new price of Lilly’s generic insulin. And the Mark Cuban Cost Plus Drug Co. plans to sell low-cost insulin. But drug pricing experts predict Lilly’s moves will not undercut those efforts. And these other initiatives to bring lower-cost insulin to market, in turn, would put pressure on Lilly to keep its prices down.

The FEHBlog agrees with these comments. Cost curve down.

From the U.S. healthcare business front, Healthcare Dive informs us

  • VillageMD, the clinical network majority owned by Walgreens, has acquired a medical group in Connecticut that operates more than 30 locations across the state.
  • On Friday, VillageMD said it snapped up Starling Physicians, which operates primary care and multi-specialty practices, for an undisclosed sum.
  • The acquisition expands VillageMD to more than 700 medical centers, as Walgreens continues to invest in expanding its clinical footprint.

Tammy Flanagan, writing in Govexec, points out irrevocable benefits decisions, e.g., FEHBP, that a federal or postal employee must make at the time they decide to take a CSRS or FERS retirement

Call Letter Released

David Ermer–Federal employment benefits, OPM, Rx coverage, U.S. Healthcare–
OPM Headquarters a/k/a the Theodore Roosevelt Building

On Tuesday, March 1, OPM issued its call letter for 2024 FEHB Program benefit and rate proposals. The benefit and rate proposal submission deadline is May 31, 2023. For sports fans, the call letter issuance is akin to the beginning of the NFL’s League Year. The only difference is that the FEHB Programs year begins sometime in the first quarter, while the NFL’s League Year begins on March 15.

The next step is for OPM to issue its technical guidance, which allows the carrier to begin drafting its benefit and rate proposal. The technical guidance comes out two or three weeks after the call letter. ,The sooner the better for carriers.

Happily, OPM moved its FEHB carrier conference from late April to late March, which better coincides with the call letter and technical guidance release. The carrier conference was moved from late March to late April in the pandemic years of 2021 and 2022.

The FEHBlog is pleased with the call letter’s substance. OPM called for assisted reproductive coverage across the FE. Asam, and as previously mentioned, OPM provided guidance on implementing the agency’s January 2023 decision to allow carriers to offer Part D EGWPs for 2024. Part D EGWPs allow carriers to integrate their prescription drug benefits with Medicare Part D for Medicare Part A only and Medicare Parts A and B annuitant members. Sweet.

The other big news for today, according to Forbes, is that

Pharmaceutical giant Eli Lilly announced Wednesday that it’s reducing prices of its most commonly prescribed insulin products by 70% and capping out-of-pocket costs for patients to $35 per month. The company has taken heat in recent years over the pricing of the life-saving drug for diabetics and the move follows action by Congress to reduce the cost of insulin for Medicare patients in the Inflation Reduction Act.

Eli Lilly’s website adds

People who rely on insulin to manage diabetes care deserve affordable access, but systemic barriers stand in the way. Through significant investments in research and solutions that offer more affordable options, we’re working to help. 

In 2020, we launched the Lilly Insulin Value Program—allowing anyone eligible to purchase their monthly prescription of Lilly insulin for $35 or less. Now, we’re announcing updates that make accessing $35-a-month Lilly insulin even easier, including:

  • An automatic $35 max out-of-pocket monthly cost for people with commercial insurance at the majority of retail pharmacies 
  • An easy-to-download savings card that provides a $35 max out-of-pocket monthly cost for people who are uninsured or need to use a non-participating retail pharmacy 

Those who need a savings card can visit our Insulin Value Program site, answer two questions, and immediately download it. The only exclusions to this $35 Lilly insulin solution are people enrolled in federal government insurance programs. Federal law provides that Medicare Part D beneficiaries also pay no more than $35 per month for insulin.

Beyond the changes listed above, we’ve also made significant price reductions to our branded and non-branded insulins.

The exclusion for federal government insurance programs stems from the federal health programs anti-kickback act, which does not include the FEHB Program because it is an employer-sponsored program. The Lilly site does not include the FEHB Program in its nonexclusive list of those government insurance programs — “Medicaid, Medicare, Medicare Part D, Medigap, DoD, VA, TRICARE®/CHAMPUS, or any State Patient or Pharmaceutical Assistance Program.” OPM does allow members to receive patient assistance for drug coverage as discussed in the call letters discussion of copay accumulator and maximizer programs.

STAT News offers more details on this development.

In other Rx coverage news —

  • Becker’s Hospital Review discusses a manufacturing issue causing a shortage in the asthma inhaler drug, albuterol.
  • The Institute for Clinical and Economic Research published an “Evidence Report on Lecanemab [Brand Name Leqembi] for Alzheimer’s Disease. ”
    • Currently available evidence is rated as promising but inconclusive to determine whether lecanemab provides a net health benefit over supportive care; the evidence suggests the drug would achieve common thresholds for cost-effectiveness if priced between $8,900 – $21,500 per year —
    • At the March 17 virtual public meeting, ICER’s independent appraisal committee will review the evidence, hear further testimony from stakeholders, and deliberate over the treatment’s comparative clinical effectiveness, other potential benefits, and long-term value for money
  • Eisai charges $26,000 per month for this drug with FDA approval, while its Medicare coverage is limited to clinical trials.

House Republicans have launched an investigation into the companies that manage drug benefits, dialing up the scrutiny of the middlemen who play an important role in how much medicines cost.

The House Oversight and Accountability Committee said Wednesday that it has sent letters to CVS Health Corp.’s CVS Caremark, Cigna Group’s Express Scripts and UnitedHealth Group Inc.’s OptumRx—the largest pharmacy-benefit managers—seeking documents about the drug-price rebates they negotiate and fees they charge.

The committee also said it has sent requests to the Centers for Medicare and Medicaid Services and other federal agencies asking for their contracts with the PBMs.

“Greater transparency in the PBM industry is vital to determine the impact that their tactics are having on patients, the pharmaceutical market and healthcare programs administered by the federal government,” said Rep. James Comer (R-Ky.), who chairs the oversight committee.

The committee is especially interested in how PBMs affect drug costs overall and the prices patients pay at the pharmacy counter and in their health-insurance premiums in particular, according to a committee staffer.

From the artificial intelligence front, Forbes informs us

Every week, Eli Gelfand, chief of general cardiology at Beth Israel Deaconess Medical Center in Boston, wastes a lot of time on letters he doesn’t want to write — all of them to insurers disputing his recommendations. A new drug for a heart failure patient. A CAT scan for a patient with chest pain. A new drug for a patient with stiff heart syndrome. “We’re talking about appeal letters for things that are life-saving,” says Gelfand, who is also an assistant professor at Harvard Medical School.

So when OpenAI’s ChatGPT began making headlines for generally coherent artificial intelligence-generated text, Gelfand saw an opportunity to save some time. He fed the bot some basic information about a diagnosis and the medications he’d prescribed (leaving out the patient’s name) and asked it to write an appeal letter with references to scientific papers.

ChatGPT gave him a viable letter — the first of many. And while the references may sometimes be wrong, Gelfand told Forbes the letters require “minimal editing.” Crucially, they have cut the time he spends writing them down to a minute on average. And they work. * * *

The fax machine isn’t going away anytime soon, says Nate Gross, cofounder and chief strategy officer of Doximity, a San Francisco-based social networking platform used by two million doctors and other healthcare professionals in the U.S. That’s why Doximity’s new workflow tool, DocsGPT, a chatbot that helps doctors write a wide range of letters and certificates, is connected to its online faxing tool.

“Our design thesis is to make it as easy as possible for doctors to interface with the novel digital standards, but also be backwards compatible with all the old stuff that healthcare actually runs on,” says Gross.

Often referred to as a “LinkedIn For Doctors,” Doximity has a $6.3 billion market cap and generates most of its revenue ($344 million in its fiscal year 2022) from pharma companies looking to advertise and health systems looking to hire. But it also offers a range of tools for doctors to help “cut through the scut” – medical slang for reducing administrative burden. The basic versions are generally free with upsells for enterprise integrations, says Gross.

Health plans use form letters too.

Strap Yourself In

David Ermer–FDA, Federal employment benefits, Medicare, No Surprises Act, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

In the 1980s and 1990s, the Washington Post had a television critic named John Carmody who would warn readers at the beginning of his column to “strap yourselves into your breakfast nook” when he had big news. So strap yourselves in, and here goes. (The photo to the right is a rough approximation of a breakfast nook, a concept which has fallen out of style evidently.

Over the next 18 to 24 months, according to the Wall Street Journal, Humana will withdraw from the employer health benefits market to focus on the government health programs market.

Humana, which currently offers many FEHB HMO plans, placed the FEHB Program in the “bye-bye” employer health benefits market even though the employer is the federal government. The FEHBlog, and Congress for that matter, prefer to view the FEHB Program as part of the employer market.

In short, Humana could have justified staying in FEHB but chose not to do so. The decision is worth pondering, particularly if you have a long-term perspective.

In other U.S. healthcare business news —

  • Healthcare Dive reports on earnings announcements from telehealth vendors Teladoc and Amwell.
    • In related telehealth news, Forbes informs us about a “new survey out from Rock Health.”
      • “While 80% of respondents said they had used telemedicine, there were only two categories where a majority of people preferred telemedicine over in-person care: prescription refills and minor illnesses. More than 60% of people surveyed preferred in-person visits for mental health and chronic condition care, while more than 70% wanted an in-person annual wellness visit. The starkest divide was on physical therapy: 80% of people preferred in-person visits, while only 20% preferred telemedicine.”
  • Biopharma Dive reports on Moderna’s earnings announcement.
    • In other vaccine news, CNN tells us
      • “The independent vaccine advisers to the US Centers for Disease Control and Prevention voted unanimously Wednesday in favor of the two-dose Jynneos mpox vaccine for adults at risk of catching the disease during an outbreak.”
      • “If the CDC agrees with the committee’s recommendation, there will be a recommendation in place to give the vaccine to people who are at risk for mpox during future outbreaks.”
      • “Even as mpox cases continue to fall, the CDC is encouraging people who are at risk to get vaccinated.”

From the preventive services front —

  • The U.S. Preventive Services Task Force issued for public comment a draft research plan regarding preventive interventions for perinatal depression. The public comment deadline is March 22, 2023.
  • The Mercer consulting firm offers useful observations on how employers and health plans can optimize their investments in preventive care.

From the Rx coverage front, Beckers Hospital Review tells us that the Centers for Medicare and Medicaid Services will not change its Medicare coverage policy on Aduhelm, an Alzheimer’s Disease treatment, based on the recent FDA approval of Leqembi.

CMS said in April 2022 that it would limit Aduhelm coverage to clinical trials only, which partly blocked the drugmaker’s efforts to sell the drug it once deemed a blockbuster. Leqembi will be subject to the same coverage plan. 

“We recognize that these medications are a unique, new class of drugs, and we regret that the decision could not be more favorable,” CMS said in a Feb. 22 statement. “After careful review of the request and supporting documentation, we are making this decision because, as of the date of this letter, there is not yet evidence meeting the criteria for reconsideration.”

If “any new evidence” becomes available or an amyloid-targeting Alzheimer’s drug receives traditional approval, CMS said it may reconsider its coverage decision.  

As readers know, CMS’s Medicare coverage decision on these drugs effectively controls the market for these drugs.

From the miscellany department

  • Affordable Care Act FAQ 57 was issued yesterday. This FAQ concerns implementation guidance for the No Surprise Act’s anti-gag clause provision.
  • FedSmith identifies five milestones toward federal retirement.
  • Kaiser Family Foundation has created federal and state litigation trackers regarding reproductive rights.

Thursday Miscellany

David Ermer–Congress, COVID-19, Federal employment benefits, HSA, Telehealth, Wellness–
Photo by Josh Mills on Unsplash

From Capitol Hill, STAT News reports

The Senate Judiciary Committee on Thursday passed legislation to prevent drug companies from gaming the patent system to delay competition from cheaper generics, but members in both parties said they still have concerns about the reforms.

It’s unclear when the bills might advance in either chamber. 

The Congressional Research Service released an analysis of healthcare coverage spending in 2021.

Meanwhile, the Health Affairs Council on Healthcare Spending and Value updates us on the recommendations proposed in its 2018 Road Map for Action.

From the Omicron and siblings front —

The Department of Health and Human Services (HHS) announced that its Secretary Xavier Becerra had given the States 90 days advance notice of the end of the Covid public health emergency on May 11, 2023.

To help you and your communities in your preparations for the end of the COVID-19 PHE, I have attached a fact sheet to this letter that includes information on what will and will not be impacted by the end of the COVID-19 PHE.2 In the coming days, the Centers for Medicare & Medicaid Services (CMS) will also provide additional information, including about the waivers many states and health systems have adopted and how they will be impacted by the end of the COVID-19 PHE. I will share that resource with your team when available.

MedPage Today informs us,

Early treatment with a single dose of pegylated interferon lambda in a highly vaccinated population of COVID-19 outpatients decreased the risk for hospitalization and emergency department (ED) visits lasting more than 6 hours, the phase III TOGETHER trial found.

Among nearly 2,000 participants with acute COVID symptoms and a risk factor for severe illness, 2.7% of those who received pegylated interferon lambda within a week of symptoms required hospitalization or ED visits, as compared with 5.6% of those given placebo (relative risk [RR] 0.49, 95% Bayesian credible interval [CrI] 0.30-0.76), reported Gilmar Reis, MD, PhD, of McMaster University in Hamilton, Ontario, and colleagues.

Results were similar regardless of vaccination status (over 80% were vaccinated), and the treatment effect with the long-acting form of interferon lambda-1 was more pronounced in those who received the subcutaneous injection with 3 days of their symptoms.

From the miscellany department —

HHS released initial guidance for Medicare’s Prescription Drug Inflation Rebate Program created by last year’s Inflation Reduction Act.

Under the Medicare Prescription Drug Inflation Rebate Program, drug companies who raise prices faster than the rate of inflation will be required to pay rebates to the Medicare Trust Fund. Below is a timeline of key dates for implementing the Medicare Prescription Drug Inflation Rebate Program:

  • October 1, 2022: Began the first 12-month period for which drug companies will be required to pay rebates to Medicare for raising prices that outpace inflation on certain Part D drugs.
  • January 1, 2023: Began the first quarterly period for which drug companies will be required to pay rebates for raising prices that outpace inflation on certain Part B drugs.
  • April 1, 2023: People with Traditional Medicare and Medicare Advantage may pay a lower coinsurance for certain Part B drugs with price increases higher than inflation.
  • 2025: CMS intends to send the first invoices to drug companies for the rebates.

The law has a circular aspect because the government needs a much lower general inflation index to get the full bang for the buck from this program. The notice also poses issues for public input.

The International Foundation of Employee Benefit Plans tells us,

The International Foundation has been tracking fertility and family-forming benefits over the past seven years. According to Employee Benefits Survey: 2022 Results, 40% of U.S. organizations currently offer fertility benefits (an increase from 30% in 2020).
Overall:

  • 28% cover fertility medications (8% covered in 2016, 14% in 2018, 24% in 2020)
  • 30% cover in vitro fertilization (IVF) treatments (13% in 2016, 17% in 2018, 24% in 2020)
  • 16% cover genetic testing to determine infertility issues (11% in 2018, 12% in 2020)
  • 17% cover non-IVF fertility treatments (6% in 2016, 11% in 2018, 11% in 2020).

In 2016, only 2% of organizations covered egg harvesting/freezing services. That jumped to 6% in 2018, 10% in 2020 and even higher in 2022, with 14% reporting that they cover the benefit.

Healthcare Dives points out, “National telehealth utilization increased 1.9% month-over-month among the privately insured population in November 2022, following one month of decline, according to a new analysis from Fair Health’s monthly tracker.” The bump is attributable to the tripledemic.

Fierce Healthcare relates, “UnitedHealthcare is rolling out a new wearables-based rewards program for members and their spouses. In UnitedHealthcare Rewards, eligible members can earn up to $1,000 per year by using wearable devices to complete health goals and activities, the insurance giant announced Wednesday.”

Health Payer Intelligence notes that “High deductible health plan (HDHP) enrollment hit a record high in 2021, with nearly six out of ten employer-sponsored health plan members enrolled in a high deductible health plan, according to a ValuePenguin survey.”

Benefits consultant Tammy Flanagan writing in Govexec, explains how federal employees can get the full advantage out of the Thrift Savings Plan, which is part of the Federal Employees Retirement System.