Monday Roundup

COVID-19 vaccine

Monday Roundup

David Ermer–CDC, COVID-19, COVID-19 vaccine, Mental health care, No Surprises Act, U.S. Healthcare–
Photo by Sven Read on Unsplash

From our Nation’s capital, Federal News Network informs us

The Office of Management and Budget filled a key personnel and performance leadership role with a familiar name.

Federal News Networks has confirmed that Loren DeJonge Schulman is starting as the new associate director for performance and personnel management today.

She replaces Pam Coleman, who left in August after 20 months in that role.

DeJonge Schulman joins OMB from the Partnership for Public Service where she was vice president of research, evaluation and modernizing government for the last two-plus years. In that role, she helped lead the Best Places to Work in Government rankings and focused on issues around improving federal workforce management.

The U.S. Office of Personnel Management announced

The U.S. Office of Personnel Management (OPM) has announced the Finalists for this year’s Presidential Management Fellows (PMF) Program. Of the more than 10,000 individuals from around the world who applied for the program, 850 Finalists were chosen. The large number of applications to this competitive program marks a record number of applications over the past ten years.  

“Presidential Management Fellows are the next generation of government leaders,” said Kiran Ahuja, Director of OPM. “The PMF Program gives Fellows the leadership skills and exposure they need to make a difference in government and an impact within their community. Congratulations to all the 2023 PMF finalists. We cannot wait to see what you will accomplish in public service.”  * * *

PMFs are appointed to a two-year, full-time Federal position with salary and benefits, where they apply their skills while engaging in leadership development training that includes experiential learning, cohort-based interactive training, and optional rotational experiences. 

In Omicron and siblings news, BioPharma Dive informs us

The U.S. has agreed to buy 1.5 million additional doses of Novavax’s COVID-19 vaccine as part of preparations for the government’s planned transition from bulk purchases to private market sales.

The agreement, announced Monday by Novavax, will support development of an updated version of the company’s shot in line with the Food and Drug Administration’s plan to annually match COVID vaccines to the most prevalent virus variants. It will also aid the company in developing smaller dose vials, which are less logistically challenging.

Novavax did not disclose the cost of the purchases, which are funded under an existing $1.6 billion contract with the government. Its shot uses a vaccine technology that has long been a mainstay and that the company claims remains an important option for those who cannot or will not take the messenger RNA-based shots from Pfizer and Moderna.

From the public health front —

  • The Washington Post discusses a horrifying CDC report on the mental health of high school students.
    • “Teen girls across the United States are ‘engulfed in a growing wave of violence and trauma,’ according to federal researchers who released data Monday showing increases in rape and sexual violence, as well as record levels of feeling sad or hopeless.”
    • In its report, the CDC steered attention to the nation’s schools, saying activities there can make a profound difference in the lives of teens. It recommended improved access to mental health services, more classroom management training for teachers, school clubs that foster gay-straight alliances, high-quality health education and enforcement of anti-harassment policies. Ideally, schools would take on multiple initiatives.”
  • NBC News reports “A handful of factors, such as education, income and job type, may increase the likelihood that people in their mid-50s will still be mentally sharp, a new study finds.”

From the No Surprises Act front, Healthcare Dive adds

One in five Americans still report receiving surprise bills, despite the ban. That’s in part because the law has notable exceptions — for example, ground ambulances were excluded from the ban, though they’re a frequent source of the bills.

In January, the HHS said it’s received significantly more requests to resolve payment disputes than the department expected.

STAT News delves into the ground ambulance billing issue today. It’s worth noting at the risk of belaboring the obvious that air ambulances are considerably more expensive than ground ambulances.

The FEHBlog was surprised to read about the number of arbitration requests in January given the Texas Medical Association’s contention that the new $350 per party arbitration fee would suppress the numbers of arbitrations. In the FEHBlog’s view, providers should place more focus on the open negotiation phase of the process.

From the electronic health records front, HealthITBuzz alerts us

A little over a year ago, we announced the completion of a critical 21st Century Cures Act requirement by publishing the Trusted Exchange Framework and Common Agreement (TEFCA). This milestone established a clear infrastructure model and governing approach for nationwide health information exchange.

Today, we marked the next major milestone during an event at the U.S. Department of Health and Human Services (HHS) headquarters, which recognized the first set of networks to be approved to implement TEFCA as prospective Qualified Health Information Networks (QHINs). Once fully onboarded, the organizations will officially be “designated” as QHINs. At this event, HHS Secretary Becerra recognized and congratulated CommonWell Health Alliance, eHealth Exchange, Epic TEFCA Interoperability Services, Health Gorilla, Kno2, and KONZA for their willingness to voluntarily step up and meet the rigorous TEFCA eligibility requirements, terms and conditions of TEFCA participation, and commitment to a 12-month go-live timeline. Collectively, the QHIN applicants have networks that cover most U.S. hospitals, tens of thousands of providers, and process billions of annual transactions across all fifty states.

Bravissimo.

From the U.S. healthcare business front —

Cigna announced a rebranding of its businesses: The Cigna Group, the global health company; Cigna Healthcare, the health benefits provider; and Evernorth Health Services, the pharmacy, care and benefits solutions provider.

Politico, upon examining whether a new CMS policy can save rural hospitals, offers us a mixed bag:

The Rural Emergency Hospital designation, aimed at sustaining emergency rooms, outpatient care and clinics, will be a major consideration for a significant number of hospitals, according to a new report from Chartis, a health care consulting group.

The policy changes are among the largest made to the rural health system in years. Through Medicare, hospitals that agree to the program requirements are guaranteed a set amount of money for facilities and a boosted Medicare reimbursement rate.

About 400 hospitals are “most likely” to consider conversion, according to the analysis, with about 80 of those “ideal” candidates for the change — often facilities on the brink of closing without growing revenues.

Several dozen hospitals are expected to move toward the new designation in the next 12 to 18 months “because they’re right on the ropes,” Michael Topchik, national leader of the Chartis Center for Rural Health, told Pulse.

Another group will wait and see how the first group does under the new rules, he said.

Still, most of the nearly 1,600 rural hospitals aren’t interested. The designation requires giving up inpatient care, a key part of many hospitals’ business and a handful of financial incentives offered through other rural health programs.

That doesn’t mean rural hospitals are thriving, though. Closures slowed significantly during the pandemic, likely because of the government’s infusion of resources through the pandemic, but are again ticking up.

Fierce Healthcare reports

Sanford Health and Fairview Health Services have agreed to push back their planned megamerger by two months.

The health systems said in a statement that they jointly determined they should “voluntarily” move the expected closure date for the deal to May 31, according to a report in MPR News. The merger was originally set to close March 31, but Minnesota Attorney General Keith Ellison asked the two providers to delay.

The deal includes 58 hospitals, and, if the two systems are joined, they would employ more than 80,000 people.

Friday Factoids

David Ermer–Congress, COVID-19, COVID-19 vaccine, Electronic health records, FDA, Rx coverage, U.S. Healthcare, Wellness–
Photo by Sincerely Media on Unsplash

From Capitol Hill, Fierce Healthcare tells us

Two top senators have reintroduced legislation that would introduce several reforms to pharmacy benefit managers, including prohibiting clawbacks of pharmacy payments. 

Sens. Maria Cantwell, D-Washington, and Chuck Grassley, R-Iowa, reintroduced on late Thursday the Pharmacy Benefit Manager Transparency Act and the Prescription Pricing for the People Act. The move shows the lawmakers are not backing down from going after PBMs in the latest Congress. 

Congress is a piker compared to OPM, which has been successfully “going after PBM’s” for over a decade.

From the public health front

  • All of the Omicron metrics are trending down. “As of January 25, 2023, there are 118 (3.7%) counties, districts, or territories with a high COVID-19 Community Level, 855 (26.6%) with a medium Community Level, and 2,242 (69.6%) with a low Community Level.”
  • Overall, about 268.9 million people or 81% of the total U.S. population, have had a single dose of Covid vaccine, “About 229.6 million people, or 69.2% of the total U.S. population, have completed a primary series.* More than 41.6 million people, or 19.9% of the eligible U.S. population ages five years and older, have received an updated (bivalent) booster dose.”
  • The CDC’s Weekly FluView again headlines, “Seasonal influenza activity continues to decline across the country.”
  • Turning to our longest-standing public health emergency, the U.S. Drug Enforcement Administration informs us

Illicitly-used xylazine is most often reported in combinations with two or more substances present, such as fentanyl, cocaine, or heroin, and can increase the potential for these drugs to cause fatal overdoses.

While scientists have not conducted much research on its effects, anecdotal reports suggest that users experience symptoms similar to those encountered via opioids, namely depression of the central nervous system. More specifically, effects associated with xylazine use include dry mouth, drowsiness, hypertension, respiratory depression, and even coma. Users can develop a physical dependence to xylazine, reporting withdrawal symptoms more serious than from heroin or methadone, such as sharp chest pains and seizures.

Note: Since xylazine is not an opioid, naloxone does not reverse its effects.

  • The Food and Drug Administration proposed changing from “time-based deferrals to assessing blood donor eligibility using gender-inclusive, individual risk-based questions to reduce the risk of transfusion-transmitted HIV. This proposal is in line with policies in place in countries like the United Kingdom and Canada.”
  • Bloomberg relates, “Americans aren’t exercising enough.  Less than a third of US adults meet suggested benchmarks for aerobic and muscle-building activities set out by health officials, according to a new study released on Thursday.”

From the Rx coverage front, STAT News reports, “After months of anticipation, the first biosimilar version of Humira will become available next week — a pivotal moment in the long-running debate about whether cheaper copies of pricey biologics can lower soaring U.S. health care costs.” Time will tell.

From the electronic health records front —

  • MedCity News identifies five ways to inject intelligence into the prior authorization process.
  • Fierce Healthcare points out that

“A new report from the Georgetown University Center for Children and Families seeks to make several reforms to the Transparency in Coverage rule to ensure the data are more usable and accessible by researchers. The goal is to ensure that the data can be used to help regulators and lawmakers target policies that can boost coverage affordability. 

“’The good news is that many of the access and usability problems stem from the technical specifications provided by the Centers for Medicare & Medicaid Services [CMS],’ the report said. ‘Most can be fixed through administrative action and better enforcement, with minimum cost burdens for the plans and issuers.’”

From the U.S. healthcare business front —

  • MedCity News informs us that health insurers continue to receive a C grade from Leapfrog.
  • Fierce Healthcare tells us, “The Minnesota attorney general’s office has formally asked Sanford Health and Fairview Health Services to postpone the March 31 closing date of their proposed merger as it seeks more information on the repercussions of the deal, Chief Deputy Attorney General John Keller said during a public meeting held Wednesday evening. The Midwest nonprofit health systems had announced their 58-hospital merger plans in November, saying at the time that joining together would expand care quality and access across their rural and urban markets. The resulting organization would employ nearly 80,000 people.”
  • Healthcare Dive reports, “In a lawsuit filed Thursday, Cigna alleged that Amy Bricker’s appointment to chief product officer of CVS’s consumer segment places the payer’s trade secrets at risk and violates her noncompete agreement.” 
  • The Wall Street Journal reports that CVS and Walmart pharmacies will follow Walgreen’s lead by reducing their retail pharmacy hours. “CVS, in a recent notice to field leaders, said most of its reduced hours will be during times when there is low patient demand or when a store has only one pharmacist on site, which the company said is a “top pain point,” for its pharmacists.” Walmart will be closing its pharmacy at 7 pm rather than 9 pm.

Happy Days are Here Again!

David Ermer–AHRQ, CDC, CMS, COVID-19, COVID-19 testing, COVID-19 vaccine, Federal employment benefits, NIH, OPM, U.S. Healthcare–
OPM Headquarters a/k/a the Theodore Roosevelt Building

The FEHBlog was delighted to read today that OPM is encouraging FEHB carriers that OPM is encouraging FEHB carriers to incorporate Medicare Part D EGWPs in their plans for 2024. The FEHBlog has been encouraging this step for years, as readers must know.

The Medicare Part D EGWPs will cushion the FEHBP against the expenses of drugs to treat Alzheimer’s Disease and other illnesses that impact annuitants over age 65. While there are many factors at play in determining premiums, this factor standing alone would lower premiums. Thank you, OPM.

From the Omicron and siblings front, the New York Times virus briefing newsletter wished its readers well today.

Now, after three years, we’re pausing this newsletter. The acute phase of the pandemic has faded in much of the world, and many of us have tried to pick up the pieces and move on. We promise to return to your inbox if the pandemic takes a sharp turn. But, for now, this is goodbye.

The American Hospital Association informs us

In a study released today by the Centers for Disease Control and Prevention [CDC}, a single bivalent COVID-19 vaccine booster provided additional protection against omicron XBB variants in adults who previously received two to four monovalent vaccine doses. XBB-related variants account for over half of currently circulating COVID-19 variants in the United States.

“All persons should stay up to date with recommended COVID-19 vaccines, including receiving a bivalent booster dose when eligible,” the authors conclude.

and

The CDC yesterday launched a website to help consumers locate no-cost COVID-19 testing through its Increasing Community Access to Testing program, which includes pharmacies, commercial laboratories and other sites that bill the tests to government and private insurers and focus on vulnerable communities. The tests may include laboratory-based nucleic acid amplification tests and rapid antigen point-of-care tests, with results typically provided in 24-48 hours.

From the public health front

  • The Hill tells us about a CDC internal reorganization.
  • The HHS Agency for Healthcare Quality and Research provides us with an infographic and report about the three most commonly treated illnesses among older adults — hypertension, hyperlipidemia, and arthritis / other joint disorders
  • Fierce Healthcare relates, “The Biden administration is planning to release three to four new payment models on advance primary care and another enabling states to assume the total cost of care for Medicare, a top official shared.”
  • HHS’s HEAL Program Director, Dr. Rebecca Baker, discusses “Research That Offers Hope to End Addiction Long-Term.”

From the U.S. healthcare business front

Healthcare Dive reports

Elevance Health, one of the nation’s largest insurers, added more members in 2022, fueled by growth in its government business thanks to continued relaxed eligibility rules on enrollment.  

Elevance ended the year covering 47.5 million people, a nearly 5% increase from the prior-year period, driven largely by growth in Medicaid members.

In turn, total revenue climbed 13% to nearly $157 billion for the year as the insurer collected higher premium revenue from its Medicaid plans.   

Net income dipped about 1% to $6 billion for the full year as expenses climbed about 14%.  

and

The CMS announced Wednesday that a record-breaking 16.3 million people signed up for Affordable Care Act marketplace plans during the 2023 open enrollment season, a result of extended pandemic-era subsidies enacted by the American Rescue Plan.

Over 1.8 million more people enrolled in marketplace coverage compared to last year — a 13% increase, and the most amount of plan selections of any year since the launch of the ACA marketplace a decade ago, according to the CMS. The record-breaking enrollment numbers include 3.6 million first-time marketplace enrollees.

STAT News tells us

The claims have become almost ubiquitous. Hospital CEO after hospital CEO stands at a podium and promises the merger being announced will improve quality and lower costs.

Once deals close, though, there tends to be little, if any, follow-up to determine whether those things actually happened. A new Journal of the American Medical Association study adds to the growing body of evidence that they don’t. The authors looked across a large swath of the country’s hospitals and physicians found that while quality did improve marginally, the prices paid for services delivered by health system hospitals and doctors was significantly higher than their non-system peers.

“You start to feel really hopeful when you hear about this, ‘Yeah, we can really improve health care,’ and then when you look at it, it’s just not there,” said Nancy Beaulieu, a study author and research associate in Harvard Medical School’s department of health care policy.

Ruh roh.

On related note, Fierce Healthcare informs us

A top insurance lobbying group plans to press Congress this session to adopt legislation that expands the footprint of site-neutral payment reform, setting up a likely clash with hospital groups. 

The Blue Cross Blue Shield Association (BCBSA), which represents 38 Blues plans, released several policy priorities for the current Congress as part of a new report Tuesday. Some of the policies focus on changing Medicare reimbursement rates to pay the same amount to clinics whether they are independent or affiliated with a hospital. Other reforms focus on prescription drugs and spurring more participation in value-based care. 

“We’re very concerned about the increasing acquisition of physician practices by hospitals in the healthcare system,” said Kris Haltmeyer, vice president of policy analysis for BCBSA, during a reporter briefing Tuesday. 

One of the association’s major priorities is to pass a bill that would remove a grandfathering provision in the 2015 Balanced Budget Act. The provision shielded certain hospital outpatient departments from billing limits established in the law, with the exception of emergency departments. 

The association also wants to require off-campus hospital sites to get a different national provider identifier than the main facility campus. They should also use a different claim form for any professional service rendered in an office or clinic owned by a hospital but not on the campus. 

Go get ’em.

Monday Roundup

David Ermer–COVID-19, COVID-19 vaccine, FDA, OPM, Rx coverage, SCOTUS, SDOH, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

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

Most people would get one Covid-19 shot annually—as they do with the flu shot—under Food and Drug Administration proposals for simplifying the nation’s Covid-19 vaccine procedures.

The drug regulator also proposed that people getting vaccinated for the first time receive vaccines that target both Omicron and the original strain of the coronavirus. 

The proposals, outlined in materials the FDA released Monday, would mark the biggest changes to Covid-19 vaccinations since boosters rolled out and are a sign of the nation’s shift to a more endemic-like approach to the coronavirus.

Vaccine experts who advise the FDA are scheduled to meet Thursday to discuss the proposals. The advisers are scheduled to vote on whether to give the bivalent shot as the initial inoculation, as is already allowed in Europe.

Makes sense to the FEHBlog.

From the OPM front, the House Oversight and Reform Committee Chairman James Comer (R-Ky.) has sent OPM Director Kiran Ahuja a letter demanding documents and a staff briefing on the recent GAO report criticizing OPM’s internal controls over family member eligibility in the FEHBP. Here’s a little free advice for my favorite agency. Rather than coming up with your own solutions, adopt solutions that have been proven to work in the private sector — the HIPAA 820 standard enrollment transaction which ties premium payments to enrollees and dependent eligibility verification audits based on statistical sampling.

From the U.S. healthcare business front —

Fierce Healthcare informs us

Elevance Health has inked a deal to acquire Blue Cross and Blue Shield of Louisiana, with the Pelican State insurer joining the Anthem Blue Cross affiliated plans.

The acquisition builds on an existing partnership between the two insurers, according to the announcement. The two jointly own Healthy Blue, a plan that serves Medicaid and dual-eligible beneficiaries. 

The combination will also allow BCBSLA to accelerate its push toward improved access, affordability and quality for its 1.9 million members, thanks to the capabilities of Elevance Health’s Carelon subsidiary, the companies said. More than $4 billion has been invested in Carelon over the past several years, building out its behavioral health, complex and chronic care programs and digital health models.

and

CVS Health has named two key leaders for its pharmacy and consumer products business, including a returning face to the company, according to a report from Bloomberg.

David Joyner, a former executive at the company, will make a return as the leader of its pharmacy services segment, which includes the Caremark pharmacy benefit manager, people familiar with the matter told the outlet. Joyner left CVS three years ago and will succeed Alan Lotvin, M.D., who is set to retire.

In addition, former Express Scripts President Amy Bricker will join the company as the chief product officer for the consumer segment, which centers on developing new products for CVS’ consumer health brands, Bloomberg reported.

Fierce Healthcare points out a twist in the second story.

That Bricker had departed Express Scripts, a subsidiary of Cigna, was revealed last week when the PBM announced it had named a new president, veteran supply chain leader Adam Kautzner. What was next for Bricker, however, was conspicuously absent from the announcement.

The FEHBlog often counsels clients on Family and Medical Leave Act issues. He had no idea until today that the Labor Department offers helpful information to healthcare provider and employees on this law. For example,

This background information can fill knowledge gaps for employers too.

From the Rx coverage front —

  • The Washington Post reports on the reaction to “the American Academy of Pediatrics guidelines, based on decades of scientific research, call[ing] for early and aggressive treatment, instead of “watchful waiting.” They urge intensive therapy for children as young as 6, weight loss drugs for those as young as 12 and surgery for teens as young as 13.”
  • The Institute for Clinical and Economic Research released a

Final Evidence Report on Fezolinetant for Vasomotor Symptoms Associated with Menopause

— Independent appraisal committee voted that evidence is not yet adequate to demonstrate a net health benefit for fezolinetant when compared to no pharmacological treatment —

—  Using point estimates from short-term clinical trials, analyses suggest this drug would achieve common thresholds for cost-effectiveness if priced between $2,000 – $2,600 per year for women who cannot or choose not to take menopausal hormone therapy —

— All stakeholders have a responsibility and an important role to play in ensuring that women have access to effective new treatment options for symptoms of menopause

The ICER upshot is “Given that many patients may benefit from readily available, effective, and low cost [menopausal hormone therapy] MHT, clinical experts agreed that it would be reasonable for payers to require prescriber attestation that patients are not appropriate candidates for MHT prior to prescribing fezolinetant.”

From the SDOH front, Health Leaders Media tells us about new ICD-10 diagnosis codes with an SDOH emphasis which will take effect on April 1, 2023.

From the telehealth front, U.S. News reports,

Despite distance and occasional technical glitches, a new study finds that most patients like seeing a surgeon for the first time via video.

The study was published Jan. 19 in the Journal of the American College of Surgeons. * * *

The study included 387 patients who participated in first-time visits between May 2021 and June 2022 at general surgery clinics across the Vanderbilt system. Researchers used a standard questionnaire to look at the quality of shared decision-making and asked patients and surgeons open-ended questions about their consultations.

In all, 77.8% of patients had an in-person visit, while 22.2% saw their doctor remotely.

Both groups reported high levels of quality communication during these appointments.

Levels of shared decision-making and quality of communication were similar between remote visits and in-person care, the study found.

In responding to the open-ended questions, patients praised the convenience and usefulness of telehealth appointments. Researchers received some negative comments about technical difficulties and not being physically present.

Tuesday’s Tidbits

David Ermer–CDC, CMS, Congress, COVID-19, COVID-19 vaccine, FDA, No Surprises Act, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill, Politico reports tonight

Top appropriators struck a deal Tuesday night on a government funding framework critical to finalizing a mammoth year-end spending package.

In a statement, retiring Senate Appropriations Chair Patrick Leahy (D-Vt.) said appropriators have “reached a bipartisan, bicameral framework that should allow us to finish an omnibus appropriations bill that can pass the House and Senate and be signed into law by the President.”

Leading negotiators didn’t release those government funding totals in announcing the deal, but appropriators have largely settled on an $858 billion defense budget in recent weeks.

That’s good news. Presumably, Congress still plans to extend the continuing resolution from December 16 to December 23 this week in order to allow time to write and pass the omnibus bill.

From the Omicron and siblings front, Healthcare Dive reports that

In the two years since the COVID-19 vaccine became available for U.S. patients, the country’s vaccination program prevented more than 18.5 million hospitalizations and 3.2 million deaths, according to new research from the Commonwealth Fund and Yale School of Public Health.

Many millions of infections were prevented, preserving hospital resources for patients who otherwise would not have received timely care, the researchers said. The vaccine also saved the country $1.15 trillion in medical costs, kept children in school and allowed businesses to reopen, the study said. 

To arrive at its findings, the study used a computer model of disease transmission, comparing the pandemic trajectory to a simulated scenario without a vaccination program. The results can be used to inform future evidence-based decisions on vaccine use to reduce disease burden, the researchers said.

The FEHBlog has no doubt that the rapidly developed mRNA vaccines pulled us out of a jam in winter 2020 while Paxlovid and other anti-virals saved us from the monstrous Omicron surge in winter 2021.

From the CMS front —

  • CMS has activated the Ground Ambulance and Patient Billing Advisory Committee required by the No Surprises Act. The Committee’s report likely will be released in the second quarter of 2023.
  • CMS released a readout from “We Can Do Better: Advancing Maternity Care Together – the first CMS convening on maternal health since the agency launched its Maternity Care Action plan in July 2022 as part of the Biden-Harris Administration’s Blueprint for Addressing the Maternal Health Crisis. Attendees discussed key actions to improve the health of pregnant and postpartum individuals – including the need for a robust and diverse maternity care workforce and the ability for consumers to easily identify health systems engaged in improving maternal care.”
  • CMS also called attention to the “recently released proposed rule that, if finalized, would modify the current National Council for Prescription Drug Programs (NCPDP) retail pharmacy standards for electronic transactions and expand the applicability of the Medicaid pharmacy subrogation transaction to all health plans.”
  • In related news, EHR Intelligence tells us, “In a recent letter, Health Level Seven International (HL7) called on the National Committee on Vital and Health Statistics (NCVHS) to include FHIR as a data standard for electronic clinical attachments. NSG encourages the public to submit comments on the proposed rule by January 9th, 2023.” The original version of HIPAA enacted over 25 years ago called for this attachments standard, which has been a thorn in CMS’s side.

In other HHS news —

  • HHS’s Agency for Healthcare Quality and Research informs us that the U.S. Preventive Services Task Force has proposed to keep in place the grade A recommendation “that clinicians prescribe pre-exposure prophylaxis with effective antiretroviral therapy to persons who are at increased risk of HIV acquisition to decrease the risk of acquiring HIV infection.” The original PREP recommendation was made in 2018.
  • The American Hospital Association relates “The Substance Abuse and Mental Health Services Administration today proposed updating opioid treatment program standards and admission criteria to expand access to treatment. According to the agency, the rule would expand the definition of OTP practitioner to include any provider appropriately licensed to dispense and/or prescribe approved medications; no longer require one year of opioid addiction for admission; add evidence-based delivery models such as telehealth; expand patient access to take-home methadone doses, and no longer require annual reports from practitioners with a waiver to prescribe buprenorphine to up to 275 patients. The agency will accept comments on the proposed rule through Feb. 14.” That makes sense to the FEHBlog.

From the drug development front —

The Wall Street Journal reports

A customized Moderna Inc. MRNA 19.63%increase; green up pointing triangle vaccine helped ward off the recurrence of melanoma in a mid-stage trial, a milestone in long-running efforts to use the shots as treatments and a big step in the biotech’s ascent.

The combination of Moderna’s personalized cancer vaccine and MerckMRK 1.78%increase; green up pointing triangle & Co.’s Keytruda cancer immunotherapy reduced patients’ risk of relapse or death by about 44%, versus Keytruda alone, in the 150-volunteer study, the companies said Tuesday.

The results, which the companies said were statistically significant but haven’t been reviewed by independent scientists, suggest promise for an emerging but unproven class of vaccines that aim to treat diseases rather than prevent infections like typical shots.

MedCity News reports

Multiple myeloma can be treated by several drugs but relapse in this type of blood cancer is common and when that happens, patients need other treatment options. Johnson & Johnson is looking to fill that need with a drug that addresses a novel target. The pharmaceutical company is seeking regulatory approval for this molecule and the most up to date clinical data supporting the application were presented during the annual meeting of the American Society of Hematology (ASH).

Patients in the Phase 1/2 clinical trial had some of the toughest cases that progressed after treatment with at least three different therapies, according to Ajai Chari, director of clinical research in the multiple myeloma program at Mount Sinai and an investigator in the study. Despite that, treatment with the J&J drug, talquetamab, led to response rates of up to 74%.

From the healthcare business front, Fierce Healthcare tells us

Operating margins for the three largest for-profit hospital chains exceeded pre-pandemic levels in the third quarter, according to a new analysis that comes as hospital lobbies are pushing for financial relief from Congress. 

The analysis, released Monday by the Kaiser Family Foundation, looked at the latest financial performance for large hospital chains HCA Healthcare, Tenet Healthcare and Community Health Systems. * * *

Kaiser’s analysis comes a day after The Wall Street Journal published a report that showed hospitals received billions of dollars in aid, with some going to profitable systems that didn’t need it. Part of the problem was a mismatch in the federal government’s allocation of the $175 billion Provider Relief Fund passed by Congress at the onset of the pandemic in early 2020, the report said. 

From the tidbits department, the FEHBlog learned at the ABA Washington Health Law Summit today

  • The third Texas Medical Association case filed November 30 and pending before District Judge Kernodle concerns the manner in which the qualifying payment amount is calculated – a new issue which nevertheless could have been joined to the second lawsuit. Go figure.
  • In 2018, Congress passed a law called the Eliminating Kickbacks in Recovery Act (“EKRA”), 18 U.S.C. § 220. The Epstein, Becker and Green law firm explains, “EKRA initially targeted patient brokering and kickback schemes within the addiction treatment and recovery spaces. However, since EKRA was expansively drafted to also apply to clinical laboratories (it applies to improper referrals for any “service”, regardless of the payor), public as well as private insurance plans and even self-pay patients fall within the reach of the statute.”

Thursday Miscellany

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

From Capitol Hill, the Wall Street Journal reports

A top Senate Democrat said that his party planned to introduce an omnibus spending bill Monday, aiming to pressure Republicans to accept a deal or risk an alternative that would freeze government spending at current levels for the full year and cut off the ability to reallocate money in military and other programs.

Senate Appropriations Committee Chairman Patrick Leahy (D., Vt.) said that the measure would provide military funding at the level Congress is authorizing in its separate defense policy bill—some $858 billion, or roughly a 10% increase—while also paying for what he called a needed increase to nondefense programs.

“This is a reasonable path forward, and I suggest my Republican friends take it,” Mr. Leahy said. * * *

If no deal is reached as the end of the year approaches, lawmakers have said they might need to fall back to a so-called continuing resolution, which funds the government at current levels. Various lawmakers have floated stretching funding into early 2023 or for the full fiscal year, which ends in September. 

The path forward was unclear, as neither House Speaker Nancy Pelosi (D., Calif.) nor Senate Majority Leader Chuck Schumer (D., N.Y.) announced votes on an omnibus bill for next week.

The Journal adds,

House lawmakers on Thursday passed a defense policy bill [discussed in yesterday’s FEHBlog post] that authorizes U.S. military leaders to purchase new weapons and increase pay for troops, and lifts a requirement for members of the military to get vaccinated against Covid-19. * * * The legislation is expected to pass the Senate by the end of next week before heading to President Biden’s desk for his signature.

STAT News tells us

Key decision makers in Congress are closer than they’ve been in years to revamping the way the government regulates some of the diagnostic tests that patients use to make crucial decisions about their health care [due to the Theranos fiasco].

If the VALID act passes, the FDA wouldn’t regulate every single clinical test, but only tests considered “high risk” to patients, where the risk to patients of an inaccurate result could cause serious or irreversible harm.

One example would be a test for breast cancer that could lead a patient to have a mastectomy, Boiani said. Another would be a genetic test that could determine which cancer treatment patients receive, said Jeff Allen, the president and CEO of Friends of Cancer Research.

From the Federal Employee Benefits Open Season front, Tammy Flanagan writing in Govexec and Drew Friedman writing in Federal News Network offer last minute decision-making tips.

Investment News provides advice on income adjusted Medicare premium issues.

Most Medicare beneficiaries will pay the standard Part B premium of $164.90 per month in 2023, down slightly from this year’s monthly premium of $170.10. Medicare Part B covers doctors’ fees and out-patient services. Coupled with a huge 8.7% cost-of-living adjustment in Social Security benefits next year, most retirees will enjoy larger monthly net Social Security benefits after automatic deductions for their Part B premiums in 2023.

But about 8%, or about 5 million, of the nearly 63 million Medicare beneficiaries will pay more than the standard monthly premium for both Part B and Part D prescription drug plans based on their income. My husband and I are among them.

For 2023, single beneficiaries with incomes of $97,000 or more and married couples with joint incomes of $194,000 or more pay a Medicare premium surcharge, officially known as an income-related monthly adjustment amount, or IRMAA. The thresholds increased from $91,000 and $182,000, respectively, in 2022, meaning some beneficiaries may avoid IRMAA surcharges altogether in 2023 or pay less than this year due to the inflation adjustments of the income tiers that trigger those surcharges.

In other health benefits news, Insurance News Net informs us

The average per-employee cost of employer-sponsored health insurance rose by 3.2% in 2022, according to Mercer’s 2022 National Survey of Employer-Sponsored Health Plans, released today.

US employers expect a sharper increase of 5.4% in 2023 — and faster cost growth in the years ahead seems likely

 For now, most employers are prioritizing enhancing benefits to attract and retain workers over cost-cutting; enhancements range from adding perks to improving healthcare affordability

 Mental health remains a top concern of employers and employees – and virtual mental healthcare is proving key to improving access to services

From the Rx development and coverage front, we have three reports from STAT News —

  • Well, this government action didn’t take long. STAT News relates “The Food and Drug Administration announced Thursday it had amended the emergency use authorizations for the updated Moderna and Pfizer-BioNTech Covid-19 boosters, to allow their use in children aged 6 months and older.”
  • Also according to STAT News, “A year ago, the [Purchaser Business Group on Health] coalition created Emsana Health that, in turn, hatched the EmsanaRx pharmacy benefit manager. [Beginning March 1, 2023,] EmsanaRx will run the technology to ensure prescriptions handled by Cuban Cost Plus Drugs are paid and fulfilled, and report all this information back to the [self-funded] employer. In exchange, EmsanaRx will take a flat 1.5% fee for legal, administrative, and data sharing services, but not charge more than $3 for each insurance claim and will pass along any rebates collected.”
  • Finally from STAT News, “Medicare is willing to reevaluate its coverage of Alzheimer’s drugs in light of a new therapy, called lecanemab, that has shown potentially more promising patient data than its controversial predecessor, Aduhelm, according to the official who oversees the program. “I can’t speak to any specifics, but just to say that our door is really open,” Chiquita Brooks-LaSure, administrator for the Centers for Medicare and Medicaid Services, said Thursday at the Milken Institute Future of Health Summit when asked about how the agency will approach lecanemab. “We will look at it as new data comes.”

From the public health front —

An outside group [the Reagan Udall Foundation] that was asked to examine problems at the Food and Drug Administration in the wake of an infant formula crisis this year offered a scathing indictment of the agency’s structure and culture and recommended major restructuring, including possibly breaking up the agency so that oversight of the food system gets more attention. * * *

In a statement, FDA Commissioner Robert M. Califf said he will review the report and make decisions about the future of the agency with input from experts inside and outside the FDA.

  • The Congressional Research Service issued an “In Focus” report on “Regulating Reproductive Health Services After Dobbs v. Jackson Women’s Health Organization.”
  • Health Payer Intelligence tells us

Overall, major health outcomes measures are trending in a negative direction, according to America’s Health Rankings Annual Report for 2022.

The Annual Report examines 23 measures to assess health outcomes trends nationwide, including measures for eight chronic conditions. The data for these measures primarily represented 2021 outcomes, but some measures drew from 2018, 2019, 2020, and 2022.

A Morning Consult online survey conducted in October 2022 informed the results as well as racial and ethnic subpopulation data and a total of 80 national and state measures to assess the state of healthcare in the US.

Based on the findings, the coronavirus pandemic has continued to have ripple effects on healthcare. The top three major trends in health outcomes are:

  • Increased drug deaths
  • Increased non-medical drug use
  • Increased premature death

Midweek update

David Ermer–ACA, Congress, COVID-19, COVID-19 vaccine, Electronic health records, NCQA, NIH, No Surprises Act, OPM, U.S. Healthcare–

From Capitol Hill, the Wall Street Journal reports

Republicans won a majority of seats in the House of Representatives with a victory in California, the Associated Press said late Wednesday, bolstering their ability to steer the agenda on Capitol Hill after two years of Democratic control of both chambers of Congress and the White House.

The Congressional Research Service released a report on health care provisions expiring at the end of this 117th Congress.

Healthcare Dive adds

With midterm elections resulting in a narrowly divided Congress, the HHS will be free to focus on longstanding priorities for the health department, such as implementing drug negotiation policy within Medicare, HHS Secretary Xavier Becerra said at the HLTH conference in Las Vegas on Tuesday.

“In a way, we’re now going to be able to concentrate on the work we have to still execute on,” Becerra said,

Under the Inflation Reduction Act passed earlier this year, Congress granted Medicare the power to negotiate how much it pays for certain prescription drugs starting in 2026, and to receive rebates from pharmaceutical manufacturers that hike drug costs above the rate of inflation starting in 2023.

Of course, HHS and its partners have a lot of work on implementing the No Surprises Act. Health Payer Intelligence discusses the good faith estimate and advance explanation of benefits comments that an ERISA plan trade association, ERIC, submitted to the NSA regulators yesterday.

In other HLTH 2022 conference news,

  • Healthcare Dive tells us about Google’s plans for offering personal health records and Maven Clinic‘s efforts to build a maternal health business by, e.g., recently landing a $90 million Series E amid increasing investor focus on women’s health.
  • MedCity News informs us, “Cell and gene therapies are offering patients potentially curative treatments for a growing scope of diseases. Insurance companies are trying to figure out how to pay for them. Industry consultants speaking at the HLTH conference offered some strategies they see payers taking to these new therapies.”

From the federal employee benefits front,

  • Govexec collected all of its current Open Season articles for convenient access.
  • Reg Jones, writing in Fedweek, recommends that federal employees contemplating retirement should retire on December 31, 2022.
  • Govexec reports that the Postal Service is headed into its busy season with far fewer employees than past years.

From the Affordable Care Act front —

  • The FEHBlog ran across this updated reference chart on minimum essential coverage under the ACA.
  • The U.S. Preventive Services Task Force issued its 12th Annual Report to Congress which is titled “High-Priority Evidence Gaps for Clinical Preventive Services.”

From the public health front —

  • Forbes reports “Researchers at the University of Houston have developed a vaccine that could block the effects of fentanyl and prevent addiction, according to a new study that could unlock solutions to the opioid epidemic as more than 150 people die every day from overdoses connected to synthetic opioids.”
  • CNN reports “The five-year lung cancer survival rate has increased 21%, from 21% in 2014 to 25% in 2018, making what experts call “remarkable progress” – but it is still the leading cause of cancer death in the United States. However, in communities of color, a person’s odds of surviving five years after diagnosis are much lower, at only 20%, according to the 2022 State of Lung Cancer report, which was published by the American Lung Association on Tuesday.”
  • The National Institutes of Health tells us “COVID-19 Vaccines Are Safe for People Receiving Cancer Immunotherapy, Study Confirms.”

From the miscellany department —

  • Forbes informs us “UnitedHealth Group’s pharmacy benefit manager Optum Rx Tuesday said it will put three less expensive “biosimilar” versions of Abbvie’s pricey rheumatoid arthritis drug Humira ‘in the same position as the brand’ on the PBM’s preferred list of drugs known as a formulary.”
  • MedTech Dive discusses how Labcorp, Abbott, BD, and Siemens plan to expand the home testing market
  • NCQA looks back at its recent Health Innovation Summit.

Tuesday’s Tidbits

David Ermer–ACA, CDC, COVID-19, COVID-19 vaccine, FDA, Federal employment benefits, No Surprises Act, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the Federal Employees Benefit Open Season front —

  • My Federal Retirement discusses the availability of high deductible plans coupled with health savings accounts in the FEHB.
  • A Federal Times expert, Reg Jones, explains the differences between Open Season and special enrollment periods.

In related news, Federal News Network tells us

Over 200 members of the Senior Executive Service this year will receive Presidential Rank Awards, considered the highest honor for career civil servants.

President Joe Biden picked 233 winners across a total of 33 different agencies for the 2022 awards program, the Office of Personnel Management announced on Nov. 15.

“Each and every day, our federal employees are working to address the nation’s most pressing issues, developing technologies to improve millions of lives, and ultimately, achieving the seemingly unachievable on behalf of the American public,” OPM Director Kiran Ahuja said in a press statement. “This year’s Presidential Rank Awards reflect the Biden-Harris administration’s support for hardworking civil servants who exemplify strength, integrity, industry and a relentless commitment to public service through their exceptional leadership, contributions and accomplishments.”

Kudos to the winners.

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

Moderna Inc.’s new updated Covid-19 booster shot for the U.S. generated strong immune responses in people against Omicron subvariants, according to the first data from a company-sponsored study testing the new doses in volunteers.

Moderna said Monday that people receiving the updated booster shot had more than five times the neutralizing antibodies against Omicron subvariants BA.4 and BA.5 than people who received Moderna’s original booster shot, which targeted an earlier strain of the coronavirus.

“That really bodes well for the vaccine and public health,” Moderna President Stephen Hoge said in an interview.

From the conferences’ front —

  • The American Medical Association explains what happened on the closing day of the AMA’s interim meeting.
  • Healthcare Dive offers Dive Briefs from the HLTH conference about Included Health and Elevance Health. Fierce Healthcare adds “Mental health provider SonderMind acquired neuroscience company Total Brain with the goal of revolutionizing personalized therapeutic care and providing individual insights into mental wellbeing.”

In other U.S. Healthcare business news

Healthcare Dive informs us

  • “Amazon has launched a message-based virtual health service called Amazon Clinic a little more than two months after the retail giant shuttered its primary care delivery business Amazon Care.
  • “Amazon Clinic, which is currently live and available 24/7 through Amazon’s website and mobile app, is a marketplace for telemedicine providers, connecting consumers with virtual doctors who can diagnose, treat and prescribe medication for a range of common health conditions like acne, birth control and migraines, the retail giant said.
  • “Amazon Clinic will be available in 32 states at launch, with plans to expand to additional states in the coming months, according to a Tuesday blog post announcing the news. * * *
  • “Consultation cost will vary by provider, including follow-up messages with a clinician for up to two weeks after the consultation. Consultations start at $30.
  • “Amazon Clinic does not accept insurance. The company didn’t disclose whether that would change in the future.”

Minnesota Public Radio tells us

Nearly a decade after unsuccessfully attempting a merger, South Dakota-based Sanford Health and Minnesota’s Fairview Health Services said Tuesday they’re again in talks to combine.

The two regional health care giants say they intend to complete a merger next year. The new entity would be called Sanford Health and be run by Sanford’s current CEO. The deal would include the University of Minnesota hospitals, which Fairview purchased in 1997.

Financial details and any cost-cutting plans tied to the proposed merger were not immediately disclosed.

From the Food and Drug Administration front —

On Thursday [November 10], the FDA, in conjunction with the CDC, released results on youth tobacco use from the 2022 National Youth Tobacco Survey. Findings show that in 2022, more than one in 10 middle and high school students (3.08 million) had used a tobacco product during the past 30 days – including 16.5% of high school and 4.5% of middle school students. The full results are available here. 

Today, the FDA announced an unprecedented advancement in foodborne illness prevention through the finalization of a rule to more effectively trace contaminated food through the food supply, whether sourced in the U.S. or abroad. 

Also [t]oday, the FDA issued a Federal Register notice, Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use, that may help facilitate the development and approval of certain nonprescription naloxone drug products, including through the switch of certain naloxone drug products from prescription status to nonprescription status. Naloxone is a medicine that can help reduce opioid overdose deaths and when administered timely, usually within minutes of the first signs of an opioid overdose, can counter the overdose effects.

From the No Surprises Act front, today was the deadline for the public to submit comments to the NSA regulators concerning two unnecessarily complicated consumer protections found in the law — the good faith estimate and the advance explanation of benefits. In the FEHBlog’s view, the NSA regulators would be well served if they limited those protections to surprise billing situations not elsewhere covered by the law, for example, (1) complicated procedures and (2) reoccurring services that take place over a prolonged period, e.g. chiropractor care, mental health care. The WEDI group, which is an advisor to the HHS Secretary, also offers useful comments on the matter.

From the Affordable Care Act front, the U.S. Preventive Services Task Force gave an inconclusive (I) grade today to screening for obstructive sleep apnea in adults. “The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for obstructive sleep apnea in the general adult population.” The USPSTF previously graded the apnea screening service an I grade in January 2017.

In closing, here’s a tidbit from the Wall Street Journal

The Earth is now home to eight billion people, the United Nations said, because people are living longer and fertility rates have surged in some countries. * * *

There were about 300 million people on Earth two millennia ago, according to the U.N. The population fluctuated in the centuries after that, largely because of plagues and natural disasters. Then the population accelerated, reaching one billion in 1804, four billion in 1974 and seven billion in 2011. * * *

Demographers project the world will reach its next population milestone—nine billion—around 2037.

The U.N. predicts that the global population will peak at around 10.4 billion during the 2080s and remain near that level until the start of the next century. Another forecast, from the Wittgenstein Centre for Demography and Global Human Capital at the University of Vienna, has it peaking at 9.67 billion in 2070, before a slow decline as fertility rates drop.

Midweek Update

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

Forbes reports

As the polls pretty much predicted, Tuesday’s midterms turned out to be very close in terms of the balance of power between the two parties. As of this writing [Wednesday evening] it’s still not clear which party controls the House and Senate. But in several states, there were important healthcare issues on the ballot that were settled more decisively. In South Dakota, voters approved an expansion of Medicaid benefits, adding itself to the list of many other states that have bypassed legislatures to expand the program by ballot initiative. Voters in Michigan, California and Vermont approved Constitutional amendments protecting abortion rights while voters in Kentucky rejected an amendment that would have stated abortion rights are not protected in the state. Meanwhile, in Arizona many of the headline races are still too close to call as of this writing, but one vote that isn’t is an overwhelming “Yes” for Proposition 209, which expands property and assets that can’t be collected against medical debt and also reduces the interest rate that can be charged on it. 

From the Omicron and siblings front, protein-based Covid vaccine manufacturer Novovax reports on its third-quarter earnings and the value of its vaccine as a booster. In addition, Novovax says that it has delivered over 94 million doses of its vaccine worldwide.

From the U.S. healthcare business front, we have a trifecta from Healthcare Dive.

Healthcare Dive informs us

More than 30 healthcare associations and advocacy groups joined the American College of Emergency Physicians in asking President Joe Biden to prioritize finding solutions to the problem of overcrowded hospital emergency rooms.

Strained emergency departments are coping with an increase in boarding, a term for when patients are held in the ED longer than they should be because of a lack of available inpatient beds. The problem has led to gridlocked EDs filled with patients waiting, sometimes in life-threatening situations, the ACEP and other groups warned Monday in a letter to the president. “Boarding has become its own public health emergency,” the letter said.

The organizations urged the Biden administration to convene a summit of stakeholders from across the healthcare system to identify immediate and long-term solutions to the boarding problem.

Holy cow!

Healthcare Dive tells us

Elevance Health inked a deal to acquire a specialty pharmacy that caters to patients with complex and chronic conditions like cancer and multiple sclerosis.

The insurer said BioPlus will complement its existing pharmacy benefit manager, IngenioRx, providing patients with specialty drugs and a whole-health approach.

After closing and integrating BioPlus into operations, the company will be able to leverage the insights from both pharmacy and medical benefits, Elevance announced on Wednesday.

Working together, BioPlus’ pharmacy team will be able to identify “a patient who may need behavioral health support or in-home care services” and “seamlessly connect that patient to services to address their whole health needs,” Elevance said.

The deal is expected to close in the first half of 2023. Financial terms of the deal were not disclosed.

Healthcare Dive also explains why Cigna invested $2.5 billion in Walgreen’s combined Village MD / Summit Health primary care company.

Unlike many other primary care physician groups, VillageMD is focused on the commercial market, which brings in two-thirds of its revenue. That plays to Cigna’s strength in the employer market, as the majority of its customers are commercial employers, according to Credit Suisse analyst A.J. Rice.

As part of its investment, Evernorth will develop value-based agreements with VillageMD. The two will work together to optimize sites of care and patient outcomes through VillageMD’s physician network and Evernorth’s health services businesses, which include pharmacy benefit manager Express Scripts, specialty pharmacy Accredo and virtual care provider MDLive.

Beckers Hospital Review discusses how CVS, Amazon and Walgreens are pushing into primary care, and home health care.

From the healthcare quality front

The HHS Agency for Healthcare Quality and Research’s Director offers a blog post about how “AHRQ’s Research and Tools Help Transform Delivery of Primary Care.”

Patient Engagement HIT relates

Personal health record (PHR) use is key to driving patient engagement, with recent JMIR Cancer data showing PHR use among colorectal cancer survivors increasing access to follow-up care and screening by more than 30 percentage points.

Additionally, PHR use increased the proportion of survivors who believed access to certain follow-up cancer screenings was important to their health and well-being, according to researchers from the Regenstrief Institute, the VA, and Indiana University’s schools of medicine and nursing.

PHRs are different from EHRs in that they are patient-facing and give users insights into their own health information. Most PHRs, particularly PHRs “tethered” to the EHR, come with some secure messaging and patient notification systems, giving the technologies even more patient engagement power.

Revcycle Intelligence reports

Hospitals work hard to avoid “never events,” or serious, largely preventable, and harmful events identified by the National Quality Forum (NQF). These never events include performing surgery on the wrong patient or accidentally leaving an item in a patient after an invasive procedure. However, some industry experts are now calling onthe healthcare industry to consider a new set of never events that are administrative in nature, such as aggressive medical debt collection.

Dave A. Chokshi, MD, MSc, FACP, senior scholar at CUNY School of Public Health and Health Policy and former Commissioner at the New York City Department of Health and Mental Hygiene, and Adam L. Beckman, BS, of Harvard’s Medical and Business Schools, identify five new hospital never events in a new JAMA Health Forum article. They say that hospitals should never:

  1. Aggressively pursue medical debt against patients who cannot afford their bills
  2. Spend less on community benefits than it earns in tax breaks from non-profit status
  3. Flout federal requirements for hospitals to be transparent with patients about costs
  4. Compensate hospital workers less than a living wage
  5. Deliver racially segregated care

That approach could get the attention of hospitals.

Finally, Med City News informs us

More than three quarters, or 77%, of reproductive-aged women want birth control pills to be made available without a prescription, provided that research proves the pills safe and effective, a new survey shows.

“Oral contraceptives are the most commonly used method of reversible contraception in the U.S., and studies suggest that [over-the-counter] access would increase use of contraception and facilitate continuity of use in addition to saving time spent on travel, at a doctor’s office, and off work,” the report stated.

Under the Affordable Care Act, most private health insurance plans are required to cover FDA-approved birth control, but it must be prescribed. However, 41% of women at reproductive age are not aware of this. About 70% of women with private insurance said their health plan fully covered their birth control, but about a quarter said they had to pay some out-of-pocket.

The ACA rule also applies to FEHB plans. The FEHBlog is metaphysically certain the ACA regulators would extend this rule to over the counter contraceptive if the Food and Drug Administration can get its act together.

Mid-week Update

David Ermer–ACA, AHRQ, CDC, COVID-19, COVID-19 vaccine, NCQA, NIH, OPM, Rx coverage, U.S. Healthcare–

Following up on this week’s posts

Forbes unpacks the colonoscopy study that the FEHBlog discussed in Monday’s post. The critical consideration is that “while colonoscopy may not be the gold standard it’s been made out to be, one or more colorectal cancer screening tools are essential to detect cancer and lower mortality rates.” Check it out.

Prof. Katie Keith writing in Health Affairs Forefront explores the final family glitch rule that the FEHBP mentioned in yesterday’s post. Two points suggest to the FEHBlog that the final rule will not materially impact the FEHB Program.

This situation—where employee-only coverage is affordable, but family coverage is not—is not uncommon. Most employers offer family coverage, but many do not subsidize it for family members which keeps the cost high for workers and their families.

That’s not the case in the FEHB Program. Moreover,

The final rule will not affect liability under the employer mandate, a fact confirmed by the IRS. Why not? The employer mandate requires certain large employers to offer coverage to employees and dependents. But penalties for violating the mandate are triggered only when an employee receives premium tax credits through the marketplace. The final rule extends premium tax credits to only the family members of workers who are not offered affordable job-based family coverage. It does not affect the eligibility of employees and thus does not implicate the employer mandate.

That’s an important consideration. Implementing the final rule is OPM’s responsibility as the FEHB Program’s regulator.

From the Omicron and siblings’ front —

The Associated Press reports

The White House on Tuesday said eligible Americans should get the updated COVID-19 boosters by Halloween to have maximum protection against the coronavirus by Thanksgiving and the holidays, as it warned of a “challenging” virus season ahead.

Dr. Ashish Jha, the White House COVID-19 coordinator, said the U.S. has the tools, both from vaccines and treatments, to largely eliminate serious illness and death from the virus, but stressed that’s only the case if people do their part. * * *

So far the Centers for Disease Control and Prevention says only about 11.5 million Americans have received the updated shots, which are meant to provide a boost of protection against both the original strain of COVID-19 and the BA.5 variant that is dominant around the world. Jha said studies suggest that if more Americans get the updated vaccines, “we could save hundreds of lives each day this winter.”

The American Hospital Association informs us

The Centers for Disease Control and Prevention today recommended Moderna’s bivalent COVID-19 vaccine booster for children aged 6-17 and Pfizer’s bivalent COVID-19 vaccine booster for children aged 5-11 after the Food and Drug Administration authorized them for these ages. CDC previously recommended the Pfizer bivalent booster for Americans 12 and older and the Moderna bivalent booster for adults. The boosters protect against the most recently circulating omicron variants as well as the original virus strain.

MedPage Today offers more information on this FDA decision and a modeling study of 1.2 million global Covid patients showing (1) “Long COVID — defined as one or more clusters of symptoms lasting three months or longer — occurred in about 6% of people with symptomatic SARS-CoV-2 infection” and (2) “at one year, 15% of long COVID patients had ongoing cognitive or respiratory problems or fatigue.”

In other public health news, NPR offers a transcript of a monkeypox discussion among NPR healthcare reports. The upshot is

Just a few months ago, it looked like the U.S. had lost its chance to get monkeypox under control. Cases were soaring, and vaccines were in short supply. But now the story has taken a turn and this time in a good direction. In fact, some disease experts are even raising the idea that the U.S. could nearly eliminate the virus. 

From the medical research front —

Healthcare Dive reports

Walmart is getting into clinical trials with the launch of the Walmart Healthcare Research Institute, as the retail giant focuses on high-margin businesses in healthcare.

Walmart said the venture is meant to improve diversity in clinical trials, focusing on interventions and medications that can make an impact in underrepresented communities. That includes older adults, rural residents, women and minority populations, the company said in a release.

It could also become a valuable stream of revenue for Walmart from drug companies looking for participants for potential trials and studies.

The NIH Directors’ Blog tells us about two NIH-supported chemists, Carolyn R. Bertozzi and K. Barry Sharpless, who won the 2022 Nobel Prize in Chemistry for their work in click chemistry.

This form of chemistry has made it possible for researchers to snap together, like LEGO pieces, molecular building blocks to form hybrid biomolecules, often with easy-to-track imaging agents attached. Not only has click chemistry expanded our ability to explore the molecular underpinnings of a wide range of biological processes, but it has provided us with new tools for developing drugs, diagnostics, and a wide array of “smart” materials.

Kudos to the winners.

STAT News reports

Merck on Wednesday agreed to extend an ongoing collaboration with Moderna to develop a personalized vaccine for the treatment of patients with skin cancer.

Moderna is getting $250 million from Merck to secure opt-in rights to the cancer vaccine candidate, called mRNA-4157. The two companies are jointly conducting a mid-stage clinical trial that combines the customized, mRNA-based vaccine with Merck’s checkpoint inhibitor Keytruda.

Results from this randomized study will be announced before the end of the year, but the timing of Wednesday’s deal suggests Merck and Moderna have seen enough encouraging data to advance mRNA-4157 into larger studies.

From the Rx coverage front, the HHS Agency for Healthcare Research and Quality updated its consumer tool “How To Create a My Medicines List,” previously known as “My Pills List.”

From the healthcare quality front, NCQA released a slide deck and recording of last week’s Future of HEDIS webinar focused on health equity.

From the maternity care front, Health Day reports on a March of Dimes report on maternity care deserts and related matters. Here’s the federal government’s maternity care map:

Maternity care deserts [red]: low access [orange]; moderate access [yellow]; full access [light purple] Source: U.S. Health Resources and Services Administration (HRSA), Area Health Resources Files, 2021