Thursday Miscellany

CMS

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.

Tuesday’s Tidbits

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medicare, NIH, Rx coverage, U.S. Healthcare–

Happy Pi Day!

Photo by Patrick Fore on Unsplash

From the Omicron and siblings front —

  • The Wall Street Journal reports
    • In the three years since Covid-19 surfaced in the U.S., most Americans have been infected and are largely back to their prepandemic routines and workaday lives. 
    • Scientists, still in the dark about what the virus will do in the long term, warn it is too early to sound the all clear. Despite the success of a global effort to decode the SARS-CoV-2 virus and create vaccines and treatments to combat it, there remains uncertainty about how the virus will behave, the path of its mutations and Covid-19’s long-term effects. 
    • Covid-19 vaccines are widely available, but researchers don’t yet know enough about how the virus might change or how long immunity lasts to be certain who should get future boosters or how often. The unknowns could have public-health consequences in the years ahead, virus experts said.
    •  “A big question is how will that play out over time?” Bronwyn MacInnis said of the virus’s mutations. She is director of pathogen genomic surveillance at the Broad Institute of MIT and Harvard, a biomedical research center in Cambridge, Mass. “Are there other tricks we have yet to see?” she said. * * *
    • “Any time someone talks about Covid, I think it’s good to start with a lot of humility,” Moderna Chief Executive Officer Stéphane Bancel said. “It’s still a new virus. So we don’t know everything.”
  • The Food and Drug Administration (FDA) announced amending “the emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to provide for a single booster dose of the vaccine in children 6 months through 4 years of age at least 2 months after completion of primary vaccination with three doses of the monovalent (single strain) Pfizer-BioNTech COVID-19 Vaccine.”
  • Yesterday, The FDA took the following steps concerning the Johnson and Johnson (Jannsen) vaccine.
    • The Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to include a Warning conveying that reports of adverse events following use of the vaccine under emergency use authorization suggest increased risks of myocarditis and pericarditis, particularly within the period 0 through 7 days following vaccination. The Fact Sheet for Recipients and Caregivers was also revised to include information about myocarditis and pericarditis following the administration of the Janssen COVID‑19 Vaccine. An additional revision to the Fact Sheets was made to include that facial paralysis (including Bell’s Palsy) has been reported during post-authorization use. Also, the scope of authorization for a booster dose of the Janssen COVID-19 Vaccine has been revised to reflect that the vaccine may be administered as a first booster dose at least 2 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine. The FDA reissued the letter of authorization for the Janssen COVID-19 Vaccine to revise the scope of authorization related to the administration of a booster dose and the conditions of authorization related to the Vaccine Adverse Event Reporting System (VAERS) reporting requirements for vaccination providers and Janssen Biotech, Inc. to include myocarditis and pericarditis.  
    • The Janssen COVID-19 Vaccine is authorized for emergency use for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older for whom other FDA-authorized or approved COVID-19 vaccines are not accessible or clinically appropriate and in individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. The letter of authorization and revised fact sheets are available on the FDA’s website.

From the Rx coverage front —

  • Fierce Healthcare offers its insights into why the Veterans Administration decided to offer the new Alzheimer’s Disease drug Leqembi to its patients who are eligible for the drug under the FDA’s guidance. Fierce Healthcare does not expect to CMS to follow this approach later this year. Currently, Medicare covers the drug when offered in a clinical trial, while the FDA’s approach is much broader.
  • The Wall Street Journal reports,

    • Novo Nordisk A/S is set to cut the U.S. list prices for several insulin drugs by up to 75%, the latest big drugmaker to make steep price reductions amid pressure to curb diabetes treatment costs.

    • Novo, one of the biggest sellers of insulin in the U.S. and around the world, said Tuesday it would cut the list price of its NovoLog insulin by 75% and the prices for Novolin and Levemir by 65% starting in January 2024. 

    • In addition, Novo plans to cut prices for its unbranded insulin products to match the reduced price of Novo’s corresponding brands.

  • The Centers for Disease Control issued a Vital Signs report titled “Progress Toward Eliminating HIV as a Global Public Health Threat Through Scale-Up of Antiretroviral Therapy and Health System” over the period 2004 through 2022.
    • What is already known about this topic?
    • The U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) began providing HIV antiretroviral therapy (ART) worldwide in 2004. [At that time, George W. Bush was President.} Through viral load suppression, effective ART improves health outcomes and prevents transmission.
    • What is added by this report?
    • By 2022, approximately 20 million persons with HIV infection in 54 countries received PEPFAR-supported ART (62% CDC-supported); this number represents an increase of 300-fold from 66,6550 in 2004. During 2015–2022, viral load suppression rates increased from 80% to 95% among those who received testing.
    • What are the implications for public health practice?
    • To eliminate HIV as a global public health threat, achievements must be sustained and expanded to reach all subpopulations. PEPFAR remains committed to tackling HIV while strengthening public health systems and global health security.

In recognition of Patient Safety Awareness Week, Beckers Hospital Review highlights

Healthgrades recognized 864 hospitals with its 2023 Patient Safety Excellence Awards and Outstanding Patient Experience Award. Only 83 of those hospitals received both awards. 

The dual recipients spanned 28 states. Texas had the most dual recipients with 12 honorees — including three Baylor Scott and White Health hospitals. 

From the medical research front,

  • NIH researchers compared a new genetic animal model of Down syndrome to the standard model and found the updated version to be more similar to the changes seen in humans. The new mouse model shows milder cognitive traits compared to a previously studied Down syndrome mouse model. The results of this study, published in Biological Psychiatry, may help researchers develop more precise treatments to improve learning and memory in people with Down syndrome.
  • The NIH DIrectors in his blog, explains
    • “The human brain is profoundly complex, consisting of tens of billions of neurons that form trillions of interconnections. This complex neural wiring that allows us to think, feel, move, and act is surrounded by the blood-brain barrier (BBB), a dense sheet of cells and blood vessels. The BBB blocks dangerous toxins and infectious agents from entering the brain, while allowing nutrients and other essential small molecules to pass right through.
    • “This gatekeeping function helps to keep the brain healthy, but not when the barrier prevents potentially life-saving drugs from reaching aggressive, inoperable brain tumors. Now, an NIH-funded team reporting in the journal Nature Materials describes a promising new way to ferry cancer drugs across the BBB and reach disease sites [1]. While the researchers have not yet tried this new approach in people, they have some encouraging evidence from studies in mouse models of medulloblastoma, an aggressive brain cancer that’s diagnosed in hundreds of children each year.” 

Thanks, research mice.

From the healthcare costs front, the New York Times reports, “Most older cancer patients received invasive care in the last month of their lives, a new study finds. That may not be what they wanted.”

The health care system could improve end-of-life care. When palliative care is introduced soon after a diagnosis, patients have a better quality of life and less depression, a study of people with metastatic lung cancer found. Though they were less likely to undergo aggressive treatment, they survived longer.

Palliative care doctors, skilled in discussions of serious illness, are scarce in some parts of the country, however, and in outpatient practices.

Nomi Health announced today that “Diabetes costs U.S. employers approximately $245 billion a year — more than double what the entire American automotive industry is worth. * * *Employers spend more than $175 billion annually on direct medical and pharmacy costs for diabetic members, in addition to nearly $70 billion on indirect costs from employee absenteeism, reduced productivity and diabetes-related disability, the research showed.”

Additional findings from Nomi Health’s Trends in Spend Tracker research include:

  • Cost of care for diabetics is increasing twice as fast as for non-diabetics, and it’s growing at a staggering clip of nearly 20% year over year, reaching more than $20,000 average per member per year (PMPY) for employers in 2020-21.
  • A diabetes diagnosis means higher costs for patients, too, who spend about 240% more annually on medical bills and nearly 450% more on pharmacy expenses than non-diabetics.
  • The high cost of diabetes extends to the chronic conditions associated with the disease, which often cost more than the diabetes itself. Care for diabetics with ketoacidosis or kidney disease in 2020-21 cost employers 252% above the average, or $68,325 average PMPY.

This retrospective cohort analysis was conducted by Artemis — a leading benefits analytics platform acquired by Nomi Health last year

From the post-Dobbs front, Healthcare Dive relates

Senate Democrats are urging the largest retail pharmacies in the U.S. to ensure access to the abortion pill mifepristone amid ongoing confusion over legal access to the pill.

On Monday, 18 Democrats sent letters to seven of the biggest pharmacy chains in the country requesting more information about their plans to provide customers access to mifepristone — currently an open question for some chains as pressure from anti-abortion lawmakers and lawsuits target the legality of medication abortion.

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.

Monday Roundup

David Ermer–CMS, COVID-19, Mental health care, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the end of the public health emergency front –

CMS issued a comprehensive fact sheet titled “CMS Waivers, Flexibilities, and the Transition Forward from the COVID-19 Public Health Emergency.” Notwithstanding the title, the fact sheet includes sections on how the end of the PHE impacts

Private Health Insurance

Vaccines: Most forms of private health insurance must continue to cover COVID-19 vaccines furnished by an in-network health care provider without cost sharing. People with private health insurance may need to pay part of the cost if an out-of-network provider vaccinates them.

Testing: After the expected end of the PHE on May 11, 2023, mandatory coverage for over-the- counter and laboratory-based COVID-19 PCR and antigen tests will end, though coverage will vary depending on the health plan. If private insurance chooses to cover these items or services, there may be cost sharing, prior authorization, or other forms of medical management may be required.

Treatments: The transition forward from the PHE will not change how treatments are covered, and in cases where cost sharing and deductibles apply now, they will continue to apply.

Private Health Insurance and Telehealth

As is currently the case during the PHE, coverage for telehealth and other remote care services will vary by private insurance plan after the end of the PHE. When covered, private insurance may impose cost-sharing, prior authorization, or other forms of medical management on telehealth and other remote care services.

For additional information on your insurer’s approach to telehealth, contact your insurer’s customer service number located on the back of your insurance card.

Fierce Healthcare reports

Telehealth providers and advocates are balking at proposed telemedicine rules released by the Drug Enforcement Administration (DEA) late Friday. If made permanent, the rules would be a marked change from the suspension of the  Ryan Haight Online Pharmacy Consumer Protection Act, which propelled a telepsychiatry boom during the COVID-19 pandemic.

Under the proposed rule released by the DEA, developed in concert with the U.S. Department of Health and Human Services (HHS) and in coordination with the U.S. Department of Veterans Affairs, some medications would require an in-person doctor’s visit. Controlled substances including stimulants like Adderall and opioids such as oxycodone and buprenorphine used to treat opioid use disorder (OUD) would require at least one in-person visit.

The DEA created a 30 day public comment period for this proposed rule.

From the U.S. healthcare business front, STAT News tells us about this surprising twist

On Friday, the Food and Drug Administration issued an emergency authorization for the first at-home test that can detect flu and Covid-19 — but for the test’s maker, Lucira, the long-anticipated authorization may have taken too long. The company filed for bankruptcy on Feb. 22, directly blaming the “protracted” FDA authorization process for the over-the-counter combination test for its financial troubles. * * *

The company’s lawyers indicated in the bankruptcy hearing that Lucira was not able to find anyone willing to buy the company prior to the Chapter 11 filing. With the only authorized at-home flu test on the American market, it’s an open question whether the company’s continued operations will allow the company to survive or will entice another party to buy Lucira.

The FEHBlog’s guess is that drug manufacturers will be lined up at the bankruptcy courthouse door to place a bid on the company if allowed.

BioPharma Dive informs us

  • “Cancer drug developer Seagen is in early talks to be acquired by Pfizer, according to The Wall Street Journal, which cited people familiar with the situation. A deal still may not be reached, the Journal said.
  • “Last summer, the Journal reported Seagen, a Washington-based company currently worth more than $30 billion, was considering selling to Merck & Co. for upwards of $40 billion. But as Bloomberg would later report, the deal stalled out because of disagreements over price. Since then, Seagen has brought on a new CEO, the longtime Novartis executive David Epstein, who played an integral role in ramping up the Swiss pharmaceutical giant’s cancer drug division.
  • “Should Pfizer acquire Seagen, it would gain access to a slate of experimental medicines as well as four marketed products that, together, generated $2 billion in revenue last year. Pfizer recorded $100 billion in product revenue in 2022, but estimates sales from its COVID-19 vaccine and Paxlovid therapy will fall significantly in the coming months. It also expects to lose around $17 billion in annual revenue between 2025 and 2030 due to the expiration of key patents.”

From the Rx coverage front —

  • The Wall Street Journal fills us in on the side effects of the new semaglutide weight loss drugs. For example, “Semaglutide spurs weight loss by stimulating the release of insulin and lowering blood sugar. It also delays stomach emptying, which causes people to feel full quickly and stay sated for longer stretches. When a patient comes off the drug, their normal appetite returns. * * * “People who stopped taking semaglutide gained back, on average, two-thirds of the weight they lost within a year, according to a study published in August 2022 in the journal Diabetes, Obesity, and Metabolism.”
  • The Journal also reports that “Amyloid Gains Converts in Debate Over Alzheimer’s Treatments; Dispute has far-reaching consequences, including whether Medicare will pay for new anti-amyloid drugs [e.g., Aduhelm and Leqembi].” Nevertheless, “Dr. [David] Knopman [,a Mayo Clinic neurologist,] said that Leqembi’s success is only a partial vindication of the amyloid hypothesis, which in the minds of many doctors promised to stop Alzheimer’s in its tracks or even reverse certain symptoms.” 

From the mental health care front, David Leonhardt, the New York Times Morning columnist, “examines the raging debate about smartphones and teenage mental health.”

I called Lisa Damour last week and asked what advice she would give to parents. Damour is a psychologist who has written two best-selling books about girls and just published a new book, “The Emotional Lives of Teenagers.” She is no anti-technology zealot. She thinks social media can have benefits for teenagers, including connections with peers. But she also sees reason for concern.

Her first piece of advice is not to blame teenagers. They didn’t invent smartphones, and earlier generations would have used those phones in the same ways that today’s teens are.

Her second piece of advice might be summarized as: less. She believes teenagers should rarely have their phones in their bedrooms, especially not at night. A phone is too disruptive to sleep, and sleep is too important to mental health.

Parents can also introduce digital technology in stages, recognizing that a 13-year-old brain is different from a 17-year-old brain. For younger teens, Damour suggests a phone that can send and receive texts but does not have social media apps.

From the miscellany department –

  • Beckers Hospital Review provides details on the business model of One Medical, which became part of Amazon last week.
    • The company employs primary care providers across more than 125 clinics in 19 markets, according to its website. One Medical then partners with local hosptials and health systems to provide specialty care.
    • One Medical offers a subscription-based membership — for $199 a year (though Amazon is now offering a promotion for $144 annually) — that gives patients access to its digital health platform, with 24-7 access to virtual care and online appointment booking and prescription renewals. The company still bills those patients’ insurance for the visits.
  • Govexec reports “The federal employees appeals board is setting new precedents restricting when agencies can fire employees who were injured on the job, issuing new rulings on cases that languished for years while the agency was rendered partially incapacitated.”
  • The Wall Street Journal tells us “The White House said there is no consensus within the Biden administration over the origins of the Covid-19 virus, a day after the disclosure of an Energy Department assessment that the pandemic likely originated with a leak from a Chinese lab.” 

Midweek Update

David Ermer–CMS, COVID treatment, FDA, Medicare, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From the Affordable Care Act front, the WTW consulting firm informs us

Group health plans and health insurance issuers will not be required to submit certain information on air ambulance services by March 31, 2023 (the deadline included in an example in the proposed regulations). The Centers for Medicare & Medicaid Services has informally confirmed that since final regulations have not yet been issued, no reporting is required in 2023.

Also following up on recent posts, Healthcare Dive tells us that

Amazon completed its $3.9 billion acquisition of primary care chain One Medical on Wednesday, significantly increasing its healthcare offerings with the addition of physical medical clinics.

and

UnitedHealth has closed its $5.4 billion acquisition of home health business LHC Group, continuing a trend of payers elbowing into direct care delivery.

In other U.S. healthcare business news, Forbes points out that

Aledade, a startup that helps primary care doctors enter into value-based contracts with insurers, has acquired artificial intelligence software company Curia. The acquisition follows a pilot program, where Aledade used Curia’s predictive algorithms to identify 8,000 patients to get them enrolled in a special end-of-life care program. 

In a bit of good regulatory news for the FEHB Program, the CMS has delayed for up to one year final rulemaking on a civil monetary penalty rule for Medicare secondary payer violations. The proposed rule issued in Feburary 2020 treated FEHB plans and other group health plans inequitably as compared to non-group health plans, including trial lawyers. The FEHBlog is glad that CMS is trying to create a fair rule.

In other regulatory news, the Food and Drug Administration announced filing civil monetary penalty complaints against four e-cigarette manufacturers.

From the medical research front, MedPage Today reports

Patients with mild to moderate COVID-19 treated with the oral antiviral ensitrelvir within 5 days of symptom onset saw their symptoms resolve a day earlier, according to data from a phase II/III randomized trial.

Median time to symptom resolution was 24.3 hours earlier for patients treated with 125-mg ensitrelvir compared with those receiving placebo (P=0.04), reported Takeki Uehara, PhD, senior vice president of drug development and regulatory science at Shionogi and Co. in Osaka, Japan, during the Conference on Retroviruses and Opportunistic Infections. * * *

Ensitrelvir is a novel 3C-like protease inhibitor that targets the SARS-CoV-2 virus. “Because of its mode of action, ensitrelvir maintains antiviral activities across various different types of variants, including recently circulating Omicron variants,” Uehara said.

Of note, follow-up of patients continued out to 3 months and 6 months to evaluate the drug’s effectiveness on long COVID.

and

An important new study came out last week in the New England Journal of Medicine (NEJM), which found that a candidate vaccine against RSV was highly effective in preventing lower respiratory tract (read: lung) disease [in adults]. The study also found the vaccine prevented severe disease.

The study has many of the features you want to see from a well-conducted study: the vaccine was compared to placebo and the study was blinded, meaning that participants and the scientists carrying out the analysis were not aware of who got what. The study had nearly 25,000 participants and was carried out across 17 nations.

The vaccine was found to be over 80% effective against lower respiratory tract disease (the main outcome the study was designed to measure) and 94% effective against severe disease. This is great news.

.From the Rx coverage front —

  • Bloomberg relates “Eli Lilly & Co said on Tuesday that all doses of its new diabetes drug Mounjaro are now available after social-media enthusiasm about the drug’s weight-loss benefits sparked a two-month-long shortage.”

while

  • The Wall Street Journal reports
    • Drugs like Ozempic have become so popular among people seeking to lose weight that they are now in short supply for patients with diabetes who depend on the medicines.
    • Diabetes patients said they are spending hours trying to find nearby pharmacies that have their prescriptions in stock. If they don’t, some patients have had to reduce dosing of Ozempic and similar drugs to stretch out their supplies, or switch to alternative drugs.
    • The shortfalls are making it harder for people with diabetes to keep their blood-sugar levels low and limit their risk of complications like kidney disease and damage to blood vessels, doctors said.  * * *
    • Novo Nordisk A/S, which sells Ozempic, has been moving to expand production capacity. People may still experience periodic shortages, however, Chief Executive Lars Fruergaard Jorgensen said, because the work hasn’t been finished while demand may remain high. 
  • Biopharma Dive tells us
    • By and large, doctors appear to be comfortable prescribing biosimilar drugs, the copycat version of biologic medicines like inflammatory disease drug Humira or eye treatment Lucentis. But they aren’t yet sure the discounts offered are enough to justify switching patients who are stable on the brand-name products, according to an annual report from healthcare distributor Cardinal Health released Wednesday. * * *
    • [A] majority of physicians from the three Humira-prescribing specialties [rheumatology, gastroenterology and dermatology] said they were “very” or “somewhat” comfortable prescribing biosimilars, including 100% of gastroenterologists. Among the ophthalmologists, 48% said they were “uncomfortable from a clinical standpoint” among their primary concerns prescribing biosimilars.
    • When asked which patients they are most likely to prescribe a biosimilar, the most common response among the Humira-prescribing specialists was “existing patients for whom payers have mandated a biosimilar,” suggesting that insurers’ policies will drive uptake. However, 40% of rheumatologists said “new patients” would be the most likely people to get a biosimilar prescription.
  • Drug Channels offers its annual update on copay assistance accumulator and maximizer programs.

From the miscellany department –

  • The Milbank Memorial Fund issued a Baseline Scorecard Tracking Support for High Quality Primary Care. The baseline leaves a lot of room for improvement.
  • Fierce Healthcare informs us that CMS recently has issued price transparency warnings to hospitals, 300 of which have been satisfactorily resolved.
  • Health Payer Intelligence reports
    • While Medicare Advantage enrollment has increased by 1.5 million beneficiaries in 2023, this marks a slower growth compared to the last three years, according to data from Chartis.
    • The analysis reflects Medicare Advantage enrollment, plan, and pricing data from January 2019 to January 2023.
    • Between 2019 and 2023, Medicare Advantage enrollment has grown by 2.1 percent. As of January 2023, 46 percent of all Medicare beneficiaries are enrolled in Medicare Advantage, translating to 29.5 million people. * * *

Thursday Miscellany

David Ermer–CMS, Congress, COVID-19, Electronic health records, FDA, Mental health care, OPM, Rx coverage, SDOH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From our Nation’s capital

  • Govexec informs us that the President “doubled down Thursday on his administration’s commitment to using the federal government’s power to support underserved communities and advance racial equity.  A new executive order issued by the president builds on one he signed his first day in office as well as other executive and legislative actions.”
  • “The U.S. Office of Personnel Management (OPM), Department of Labor, and Office of Management and Budget (OMB) have developed and launched a new portal on USAJOBS for prospective Federal interns. Located at intern.usajobs.gov, the Federal Internship Portal is a one-stop shop for prospective interns to find opportunities and apply for internships in the Federal government.”
  • The Senate Commerce, Science and Transportation Committee held a hearing on PBM transparency and accountability, which Fierce Healthcare describes as the hearing as “heated.”
  • The Senate Health, Education, Labor and Pensions Committee held a hearing on healthcare workforce shortages, which Fierce Healthcare describes as the beginning of “a major effort to shore up the healthcare workforce after lingering shortages have roiled the industry.”
  • The U.S. Commissioner of Food and Drugs updated the public on his agency’s efforts prevent drug overdoses and reduce deaths.
    • In related news from MedPage Today, “Advisors to the FDA unanimously recommended the agency approve the first over-the-counter (OTC) naloxone (Narcan) product, though many committee members expressed continued concern about user instructions for the opioid overdose reversal drug. * * *While the FDA is not required to follow the recommendations of its advisory committees, it typically does.”

From the medical research front

  • STAT News tells us, “A team of researchers from Stanford and University of California San Francisco have built a predictive model that uses electronic health records to calculate the risk of sepsis, cerebral palsy, and other serious conditions in newborns. The team trained a deep learning model on health records from more than 30,000 mother-newborn pairs treated in the Stanford health system, building a neural network that could predict 24 different health outcomes. The researchres, who also published an interactive website for readers to explore the network’s data. said the predictions outperformed currently-used risk scores.” 
  • Nature explains “How a pioneering diabetes drug teplizumab offers hope for preventing autoimmune disorders. Approving an antibody therapy that pauses the progression of type 1 diabetes is a first in the field, and some say, a model for other drug developers.
  • The National Institutes of Health disclosed that “Black and Hispanic Americans appear to experience more symptoms and health problems related to long COVID, a lay term that captures an array of symptoms and health problems, than white people, but are not as likely to be diagnosed with the condition, according to new research funded by the National Institutes of Health. The findings – from two different studies by NIH’s Researching COVID to Enhance Recovery (RECOVER) Initiative – add to a growing body of research aimed to better understand the complex symptoms and other issues associated with long COVID that millions have experienced.”
  • The All of Us program shared its research roundup, focusing on heart disease this month.
  • The Robert Wood Johnson Foundation offers an award-winning scholar’s “Lessons From the Intersection of Race, Inequality, and Health.”
  • The Institute for Clinical and Economic Review “released a Draft Evidence Report assessing the comparative clinical effectiveness and value of resmetirom (Madrigal Pharmaceuticals, Inc.) and obeticholic acid (Ocaliva®, Intercept Pharmaceuticals, Inc.) for non-alcoholic steatohepatitis (NASH). This preliminary draft marks the midpoint of ICER’s eight-month process of assessing these treatments, and the findings within this document should not be interpreted to be ICER’s final conclusions.“

From the U.S. healthcare business front —

  • Beckers Payer Issues identified over thirty payers who made Forbes rankings of top U.S. employers.
  • Beckers also reports, “A federal judge granted Cigna a temporary restraining order in its lawsuit alleging former executive Amy Bricker’s departure for rival CVS Health violated a noncompete agreement, Bloomberg Law reported Feb. 15.”  A TRO is a short duration order that allows the court time to consider awarding a preliminary injunction.
  • According to Healthcare Dive
    • CommonSpirit Health announced Wednesday that it will acquire regional health system Steward Health Care in Utah for $685 million.
    • The deal marks CommonSpirit’s entry into Utah, expanding the hospital operator’s footprint to a total of 22 states.
    • CommonSpirit will acquire five hospitals from Steward, along with more than 40 clinics and other ambulatory services, the system said. The deal is expected to close later this year. CommonSpirit’s Centura Health will manage the Utah sites.
  • Also from Healthcare Dive
    • Wednesday is the last day that LHC Group will trade on the Nasdaq, suggesting UnitedHealth will complete its acquisition of the home health business prior to market open on Thursday.
    • LHC’s stock will be halted aftermarket on Wednesday, according to a Nasdaq notice. As a result, the merger is tentatively scheduled to close the next morning, subject to pending regulatory approvals.
    • Speculation that the Federal Trade Commission will move to block the $5.4 billion deal has been rampant, but reports late last month suggest that regulators are unlikely to challenge the transaction. 
    • Louisiana-based LHC is a major player in the home health space, with more than 960 locations in 37 states and $2.2 billion in revenue last year
  • The Baton Rouge Business Report discusses a foundation that would be created in the wake of the Blue Cross and Blue Shield of Louisiana sale would have more than $3 billion in assets. The Accelerate Louisiana Initiative, as the foundation would be called, would be one of the largest private foundations in the nation, says Cindy Wakefield with BCBSLA. 
  • Fierce Healthcare reports, “EHR provider Elation Health announced its acquisition of medical billing company Lightning MD. The growth adds a piece to the Elation puzzle as it seeks to become the sector’s first all-in-one technology solution for primary care practices, the company said.”

From the miscellany department —

  • Health Payer Intelligence reports, “AHIP Asks CMS to Reconsider Proposed Medicare Advantage Policy Changes. The extensive policy changes included in the proposed rule will negatively impact Medicare Advantage beneficiaries and plans, AHIP said.” It’s easier to write up orders than to implement them.
  • CMS announced that “a new chart titled Top 10 Section 111 Group Health Plan Reporting Errors, covering the July 1 – December 31, 2022, is now available in the Download section below.  Descriptions of these and all reporting errors are available for review in the GHP User Guide.”
  • WTW explains “What the end of the COVID-19 emergencies will mean for group health plans.”

Tuesday Tidbits

David Ermer–CDC, CMS, COVID treatment, Electronic health records, FDA, Medicare, Mental health care, NCQA, Rx coverage, Telehealth–
Photo by Laura Ockel on Unsplash

From the Omicron and siblings front, HealthDay tells us

Paxlovid remains a powerful weapon against the Omicron variants BA.4 and BA.5, new research shows

The antiviral continued to protect against hospitalization and death in patients [including the immunocompromised] who took it

Research is ongoing to see if Paxlovid also guards against newer Omicron variants such as XBB.1.5 and BQ.1

From the public health front —

  • Medscape reports that the five-year survival rate in pancreatic cancer is increasing.
  • MedPage Today explains that while there’s no ‘Recipe’ to reduce dementia risk, here’s how to discuss it with patients until more evidence emerges.
  • The U.S. Preventive Services Task Force reaffirmed a Grade D recommendation against routine serologic screening for genital herpes simplex virus infection in asymptomatic adolescents and adults, including pregnant persons.

From the healthcare quality front

  • Beckers Hospital Review shares Healthgrades’ 2023 list of top hospitals for joint replacement by state.
  • The National Committee for Quality Assurance opened its 2023 HEDIS public comment period yesterday. The comment period closes on March 13.

From the Medicare front —

  • The Department of Health and Human Services unveiled three models for reducing prescription drug costs charged to Medicare beneficiaries, including two-dollar generic drug prescriptions for Medicare Part D.
    • “Under this model (the Medicare High-Value Drug List Model), Part D plans would be encouraged to offer a low, fixed co-payment across all cost-sharing phases of the Part D drug benefit for a standardized Medicare list of generic drugs that treat chronic conditions. Patients picking plans participating in the Model will have more certainty that their out-of-pocket costs for these generic drugs will be capped at a maximum of $2 per month per drug”.
  • Beckers Payer Issues reports, “Medicare beneficiaries who enroll in a Medicare Advantage plan may need less retirement savings to cover their healthcare costs, an analysis published Feb. 9 by the Employee Benefits Research Institute found.”
  • Fierce Healthcare informs us
    • “Health insurers and the Biden administration are at loggerheads over whether Medicare Advantage (MA) plans will see a pay cut next year, the ramifications of which come amid increased regulatory scrutiny for the popular program.
    • “Insurer groups and some politicians charge that the latest 2024 payment rule will wind up being a 2.27% cut to MA plans after considering risk adjustment changes and other factors. The Centers for Medicare & Medicaid Services (CMS) has pushed back, arguing that isn’t true.”
  • STAT News relates, “Medicare advisers on Tuesday recommended that the program alter its requirements for drugs, diagnostics, and medical devices that face coverage restrictions [such as the Biogen Eisai Alzheimers Disease drugs] to make the process more transparent and better incorporate diversity data.”
    • Speaking of which, USA Today reports
      • One in 10 new drugs was cleared by federal drug regulators in recent years based on studies that didn’t achieve their main goals, a new study shows.
      • The study by Harvard and Yale researchers found that of 210 new therapies approved by the Food and Drug Administration from 2018 through 2021, 21 drugs were based on studies that had one or more goals, or endpoints, that wasn’t achieved. Those 21 drugs were approved to treat cancer, Alzheimer’s and other diseases.
      • Researchers said the findings raise questions about whether the federal agency’s drug approvals lack transparency about some products’ safety and effectiveness. 

In hospital pricing transparency news —

  • Healthcare Dive discusses a JAMA-published study of available hospital pricing data, which produced head-scratching results.
  • Beckers Hospital Review explains four ways CMS is trying to improve hospital price transparency in 2023. Good luck with that.

From the HR department

  • The Society for Human Resource Management tells us
    • “Employers need to understand that the timeline for submitting their demographic data to the U.S. Equal Employment Opportunity Commission (EEOC) is somewhat different this year. The agency recently confirmed that EEO-1 reporting for 2022 data is scheduled to begin in mid-July. In recent years, the starting points and deadlines for data collection have varied.”
    • “All private employers with 100 or more employees and federal contractors with 50 or more employees must file EEO-1 reports each year that summarize employee headcount by sex, race/ethnicity, and job category. This component of data collection, called Component 1, does not include pay data.
  • HR Dive explores how the Pregnant Workers Fairness Act protects pregnant workers beginning this June and how do those accommodations stack up to the federal Family and Medical Leave Act? 
  • HR Dive also notes, “Short breaks of fewer than 20 minutes taken by hourly, non-exempt employees who telework or must be counted as compensable time under the Fair Labor Standards Act — as is the case for employers working from an employer’s own location — Jessica Looman, principal deputy administrator of the U.S. Department of Labor’s Wage and Hour Administration, wrote in a Field Assistance Bulletin published Thursday.”

From the tidbits department

  • Healio advises “Adolescents and young adults with type 1 diabetes who primarily attend diabetes clinic visits via telehealth have better overall attendance and less diabetes distress compared with those who attend in person, according to study data.”
  • MedCity News states, “Since the start of the Covid-19 pandemic, there has been a 23% increase in alcohol abuse and a 16% increase in drug abuse, and people in self-isolation reported a 26% higher consumption than usual, according to the National Library of Medicine. Some apps are trying to meet this need, including Sober Sidekick and SoberBuddy.”

Midweek update

David Ermer–ACA, CDC, CMS, Congress, COVID treatment, FDA, Medicare, NIH, No Surprises Act, U.S. Healthcare–

From our Nation’s capital, HHS Secretary Xavier Becerra made a statement honoring Black History Month which began today.

The Wall Street Journal reports

President Biden and House Speaker Kevin McCarthy began face-to-face debt-ceiling discussions [today], with the latter expressing cautious optimism that they can come to a deal to avoid the first-ever default of the country’s debt.

The Hill tells us

  • Senate Minority Leader Mitch McConnell (R-Ky.) has pulled Sen. Rick Scott (R-Fla.), who tried to oust him as the Senate’s top Republican in a bruising leadership race, off the powerful Commerce Committee.  
  • McConnell also removed Sen. Mike Lee (R-Utah), who supported Scott’s bid to replace McConnell as leader, from the Commerce panel, which has broad jurisdiction over a swath of federal agencies.  

Speaking of federal agencies, Healthcare Dive informs us

The Federal Trade Commission is penalizing GoodRx for sharing users’ sensitive health information with advertisers, in the agency’s first enforcement action under the Health Breach Notification Rule.

The FTC filed an order with the Department of Justice on Wednesday that would prohibit GoodRx from sharing user health data with third parties for advertising purposes, among other guardrails. GoodRx has also agreed to pay a $1.5 million fine, though the company admitted no wrongdoing. The order needs to be approved by a federal court in order to go into effect.

Also, the President issued a Statement of Administration Policy objecting to Republican legislative efforts to end the national and public health emergencies for the Covid pandemic without further delay. The Statement explains why the White House has opted to end those emergencies on May 11.

In that regard, Health Payer Intelligence notes

CMS announced that there will be a special enrollment period on the Affordable Care Act marketplace for individuals who lose their Medicaid coverage due to the public health emergency unwinding.

“Today, CMS is announcing a Marketplace Special Enrollment Period (SEP) for qualified individuals and their families who lose Medicaid or CHIP coverage due to the end of the continuous enrollment condition, also known as ‘unwinding,’” the FAQ sheet explained.

The special enrollment period will stretch from March 31, 2023 to July 31, 2024. In order to be eligible for the special enrollment period, individuals must be eligible for Affordable Care Act marketplace coverage and must have lost their Medicaid, Children’s Health Insurance Program (CHIP), or Basic Health Program (BHP) coverage.

From the Omicron and siblings front, Beckers Hospital Review points out

The FDA altered its emergency use authorizations on Paxlovid and Lagevrio, two COVID-19 treatments, on Feb. 1 to revoke a requirement for a positive COVID-19 test before a provider can prescribe them. 

“The agency continues to recommend that providers use direct SARS-CoV-2 viral testing to help diagnose COVID-19,” the FDA said in an emailed statement. But, “in rare instances, individuals with a recent known exposure (e.g., a household contact) who develop signs and symptoms consistent with COVID-19 may be diagnosed by their healthcare provider as having COVID-19” even if they test negative.

From the public health front —

  • The Commonwealth Fund issued a report titled “U.S. Health Care from a Global Perspective, 2022: Accelerating Spending, Worsening Outcomes.” The FEHBlog’s perception is quite sunny compared to this gloomy report.
  • The National Institutes of Health is celebrating American Heart Month.
  • The National Cancer Institute offers an interesting newsletter on its work.
  • The Wall Street considers dangerous fungi that are infecting people as a result of climate change.

From the No Surprises Act front, according to Healthcare Dive, the Texas Medical Association has filed a fourth lawsuit concerning the law. This time the TMA objects to the regulators’ entirely appropriate decision to increase the arbitration administration fee from $100 split between the parties to $700 similarly split. The arbitration or IDRE process was being bombarded with arbitration requests from providers. The fee increase will focus more provider attention on the open negotiation period that precedes the arbitration. “The suit also challenges the laws’ restrictions on batching claims, which allows arbitration processes only on claims with the same service code, requiring providers to go through a separate payment dispute process for each claim related to an individual’s care episode, according to the suit.” Quelle domage.

From the U.S. healthcare business front

  • Beckers Payer Issues reports, “Humana posted revenues of nearly $93 billion in 2022 and a net loss of $15 million in the most recent quarter, according to its year-end earnings report published Feb. 1.  The company also appointed Steward Health Care President Sanjay Shetty, MD, to lead its healthcare services business, CenterWell, which includes pharmacy dispensing, provider and home health services. Dr. Shetty will start April 1. In addition, the company promoted its Medicare president, George Renaudin, to president of Medicare and Medicaid, effective immediately.”
  • Beckers Hospital Review examines whether Amazon can disrupt the pharmacy industry.

From the Medicare front, the Centers for Medicare and Medicaid Services released

the Calendar Year (CY) 2024 Advance Notice of Methodological Changes for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies (the Advance Notice). CMS will accept comments on the CY 2024 Advance Notice through Friday, March 3, 2023. CMS will carefully consider timely comments received before publishing the final Rate Announcement by April 3, 2023.

Tuesday’s Tidbits

David Ermer–CMS, Congress, COVID treatment, COVID-19, HSA, Mental health care, NIH, No Surprises Act, Patient safety, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill, Roll Call reports

The Biden administration will send its budget for the next fiscal year up to Capitol Hill on March 9, according to a memo from top White House aides.

That’s about a month later than the statutory deadline, which is the first Monday in February, though that target is often missed and there’s no penalty for doing so.

National Econonic Council Director Brian Deese and Office of Management and Budget Director Shalanda Young laid out the timing in a memo to “interested parties” that also discussed agenda topics for Wednesday’s scheduled meeting between President Joe Biden and Speaker Kevin McCarthy, R-Calif.

The memo, first reported by ABC News, said Biden will ask McCarthy to “commit to the bedrock principle that the United States will never default on its financial obligations,” a reference to the upcoming fight over the statutory debt ceiling. Treasury Secretary Janet L. Yellen has warned that the U.S. could be in danger of missed payments by early June if Congress doesn’t act to raise or suspend the $31.4 trillion debt limit.

The memo also says Biden will urge McCarthy and House Republicans to release their own fiscal 2024 budget blueprint that spells out the spending cuts they want to attach to any debt limit deal and how their budget will balance if they plan to extend expiring tax cuts.

Senator Tina Smith (D MN) and a bipartisan group of colleagues sent several large health insurers a letter requesting answers to questions about ghost networks. It turns out the ghost networks are online provider directories with errors. The FEHBlog thinks that the Senators should be pressuring the No Surprises Act regulators to implement the provider directory accuracy provision in that law.

From the Omicron and siblings front, the New York Times explores why Paxlovid, a reliable treatment, is underprescribed by doctors.

Doctors prescribed it in about 45 percent of recorded Covid cases nationwide during the first two weeks of January, according to White House data. In some states, Paxlovid is given in less than 25 or even 20 percent of recorded cases. (Those are likely overestimates because cases are underreported.)

Why is Paxlovid still relatively untapped? Part of the answer lies in a lack of public awareness. Some Covid patients also may decide that they don’t need Paxlovid because they are already vaccinated, have had Covid before or are younger. (My colleagues explained why even mild cases often still warrant a dose of Paxlovid.) * * *

Experts have increasingly pointed to another explanation for Paxlovid’s underuse: Doctors still resist prescribing it. Today’s newsletter will focus on that cause.

Some doctors have concerns that are rooted in real issues with Paxlovid and inform their reluctance to prescribe it. But experts are unconvinced that those fears are enough to avoid prescribing Paxlovid altogether, especially to older and higher-risk patients.

“What I’m doing for a living is weighing the benefits and the risks for everything,” said Dr. Robert Wachter, the chair of the medicine department at the University of California, San Francisco. In deciding whether to prescribe Paxlovid, he said, the benefits significantly outweigh the risks.

This isn’t very encouraging.

From the U.S. healthcare business front —

Beckers Hospital Review reports

Six years after regulators approved Amjevita, a biosimilar to the nation’s most lucrative drug, Humira, Amgen’s drug jumped on the U.S. market Jan. 31 with two list prices.

The biosimilar to AbbVie’s most profitable drug will either cost 5 percent or 55 percent less than Humira’s price, according to Amgen. Humira costs $6,922 for a month’s supply, meaning Amjevita’s price — depending on the buyer — will be $6,576 or $3,115. The higher price is designed to entice pharmacy benefit managers, and the lower one is for payers, according to Bloomberg. 

As Humira’s 20-year, $114 billion, 247-patent-strong monopoly ends with the first biosimilar, more copycat versions are set to premiere in the next few months.

STAT News dives deeper into the implications of Amgen’s pricing approach.

AHIP responded yesterday to CMS’s final Medicare Advantage plan audit rule.

“Our view remains unchanged: This rule is unlawful and fatally flawed, and it should have been withdrawn instead of finalized. The rule will hurt seniors, reduce health equity, and discriminate against those who need care the most. Further, the rule would raise prices for seniors and taxpayers, reduce benefits for those who choose MA, and yield fewer plan options in the future. 

“We encourage CMS to work with us, continuing our shared public-private partnership for the health and financial stability of the American people. Together, we can identify solutions that are fair, are legally sound, and ensure uninterrupted access to care and benefits for MA enrollees.” 

Is the next step the courthouse?

Money Magazine offers a list of hospitals that provide bariatric surgery with Leapfrog safety grades.

From the mental healthcare front, Fierce Healthcare tells us

Parents can now be added alongside providers, health insurers and employers to the list of stakeholders with growing concerns about mental health, according to a study by the Pew Research Center.

The study found that 40% of parents call the fact that their children might be struggling with anxiety and depression their No. 1 concern—something they’re extremely or very worried about—followed by 35% of parents who put the fear that their children are being bullied into that category.

From the tidbits department —

  • The NY Times lists ten nutrition myths that experts wish would be forgotten.
  • The NIH Directors blog explains why a “New 3D Atlas of Colorectal Cancer Promises Improved Diagnosis, Treatment.”
  • The National Association of Plan Advisors points out that “Despite a rebound in out-of-pocket health care spending in 2021, health savings account (HSA) balances increased on average over the course of the year, the Employee Benefit Research Institute (EBRI) recently found. Its analysis of HSA balances, contributions, and distributions also found, “patients sought health care services more frequently in 2021—and spent more out of pocket, as well—than they did in 2020, yet the average end-of-year balance was higher than the average beginning-of-year balance.”