Happy International Women’s Day

Happy International Women’s Day

Photo by Hannah Busing on Unsplash

The Wall Street Journal reports

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

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

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

Following up on recent posts —

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

In other news

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

FEHBlog message to Congress

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

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From our Nation’s Capital, Roll Call fills us in on the debt ceiling negotiations. Significantly,

​Economists at Moody’s Analytics estimate that the Treasury Department will run out of borrowing room by mid-August if Congress doesn’t act to raise or suspend the statutory debt limit by then.

The “x date” after which Treasury may not be able to pay all of the federal government’s bills appears to be Aug. 18, specifically, according to Moody’s economists Mark Zandi, Christian deRitis and Bernard Yaros. 

The trio laid out various scenarios and potential consequences of failure to lift the $31.4 trillion debt ceiling in a new paper this week, on a topic that was examined more closely Tuesday afternoon in a Senate Banking subcommittee hearing led by Sen. Elizabeth Warren, D-Mass. Zandi is among those slated to testify.

The propspect of a mid-August explosion may encourage Congress to suspend the debt ceiling suspension until the end of the federal fiscal year, September 30, and focus on negotiating the interrelated 2024 appropriations and the debt ceiling topics.

The President provided highlights of the Medicare proposals in his 2024 fiscal year budget. The American Hospital Association explains

The president’s fiscal year 2024 budget will propose policies to keep Medicare’s Hospital Insurance Trust Fund solvent for at least an additional 25 years by directing additional Medicare taxes and savings from prescription drug reforms to the HI Trust Fund, the White House announced today. According to the latest annual report by the Medicare Trustees, the fund currently has sufficient funds to pay full benefits until 2028. 

Among other Medicare provisions, the president’s budget will propose to eliminate cost-sharing for three behavioral health visits per year; require parity between physical health and mental health coverage; lower out-of-pocket costs for drugs subject to price negotiation; and cap Part D cost-sharing for certain generic drugs, the White House said.

The president’s FY 2024 budget is expected to be publicly released on March 9, with additional detail on March 13. AHA members will receive additional information on the president’s budget as those details are released.

Congress shared the budget with the Congressional Budget Office to analyze whether this plan will work.

Federal News Network reports on a recent GAO report about OPM.

The Office of Personnel Management is at “significant risk” of being unable to help agencies address governmentwide skills gaps, if it can’t first do a better job of addressing its internal skills gaps, GAO said in a report published last week.

Persistent internal skills gaps “could compromise OPM’s ability to implement its strategic objectives related to closing governmentwide skills gaps,” GAO said in the Feb. 27 report.

Although OPM has made progress in some areas of workforce management, such as creating an internal committee to hire and train new staff members, the agency is struggling to clearly identify and address several skills gaps within its own staff. * * *

Ron Sanders, former chairman of the Federal Salary Council and former associate director for HR policy at OPM, said the results of the GAO report were “unsurprising,” but that the reason behind the challenges may be difficult to measure.

“I think the skills gaps and have more to do with intangibles than they do with specific functional specializations,” Sanders, current president and CEO of Publica Virtu LLC, said in an interview with Federal News Network. 

Hang in there, OPM, which has a lot on its plate, as we all do.

Healthcare Dive tells us

  • The Federal Trade Commission will give the public an additional 30 days to comment on a sweeping proposal to ban employers from imposing noncompete contracts on their workers. 
  • The agency said interested parties have requested an extension, though acknowledged others oppose the delay. The public now has until April 19 to comment on the proposed rule, the FTC said on Monday.  
  • FTC Commissioner Christine Wilson said in a separate statement that she would have supported an even longer extension since the proposal is “a departure from hundreds of years of precedent.” 

MedCity News writes about the state of No Surprises Act rulemaking. Of note,

What the industry really needs from the government agencies at this point is a road map, or, as the Workgroup for Electronic Data and Interchange (WEDI) said in a recent letter to the secretary of HHS, a “glide path” that explains how the industry and the government will develop standards and operating rules together. In the letter, WEDI asked for the government’s expectations on vetting and testing standards and an estimate on timelines for implementing NSA regulations.

The FEHBlog heartily agrees with WEDI. Congress should consider amending certain provisions, particularly the good faith estimate and advance explanation of benefit provisions which should be amendments to the HIPAA electronic transaction standards and narrowed in scope.

From the Food and Drug Administration front —

  • STAT News provides an interview with Food and Drug Commissioner Dr. Robert Califf. For example

FDA Commissioner Robert Califf said on Monday that it “bothers” him that Novo Nordisk, which makes an obesity medication, funded the development of obesity coursework for medical schools. But he also said he saw it as an example of a drug company filling the void left by health systems that aren’t teaching doctors and trainees how to use new medicines.

“I think it’s a shame that you would need to depend on a pharmaceutical company for an educational program about something that’s affecting half of Americans,” Califf said during a meeting with STAT reporters and editors.

But, he said, “we also live in a practical real world. You might argue that if health systems did their jobs, you would have no need for educational programs from drug companies. But talk to people who practice medicine who are part of these big health systems and ask them how much help they get and guidance on what to do from the health systems they work for. I say this being a card-carrying lover of academic health systems, but that’s not where the money goes in academic health systems.”

  • Beckers Hospital Review informs us,

The FDA is set to decide whether to fully approve Leqembi, Eisai and Biogen’s Alzheimer’s treatment by July 6, CNBC reported March 6.

Leqembi is an antibody treatment that targets brain plaque associated with Alzheimer’s. The drug is administered intravenously twice a month and in clinical trials has shown it can slow early Alzheimer’s disease by 27 percent; however, the deaths of three trial participants may be tied to brain swelling caused by the drug.

The FDA approved the drug on an expedited basis in January, but CMS has made it accessible to patients only in clinical trials. CMS plans to provide broader coverage if Leqembi is fully approved, according to CNBC.

Covis Pharma Group said it will stop selling its drug to prevent preterm births, after a study couldn’t confirm the medicine worked and U.S. health regulators were taking steps that could have it pulled.

Makena was the only drug approved by the Food and Drug Administration to reduce the risk of preterm birth in women with a history of early deliveries.

Covis said Tuesday it wants to work with the FDA to set a wind-down period for the drug so that patients aren’t abruptly taken off of it. The company said it was acting after experts advising the agency recommended it pursue Makena’s withdrawal from the market.

Eli Lilly and Company (NYSE: LLY) today [March 3] announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for Verzenio® (abemaciclib), in combination with endocrine therapy (ET), for the adjuvant treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer (EBC) at a high risk of recurrence. High risk patients eligible for Verzenio can now be identified solely based on nodal status, tumor size, and tumor grade (4+ positive nodes, or 1-3 positive nodes and at least one of the following: tumors that are ≥5 cm or Grade 3).1 This expanded adjuvant indication removes the Ki-67 score requirement for patient selection.

From the U.S. Healthcare business front —

  • Beckers Hospital Review tells us,
    • “The first hospitals seeking CMS’ new rural emergency hospital designation have submitted their applications, Kaiser Health News reported March 6. 
    • “Hospitals that convert receive a 5 percent increase in Medicare payments as well an average annual facility fee payment of about $3.2 million, according to the report. In return, the hospitals must close their inpatient beds and focus solely on outpatient and emergency care.”
  • Healthcare Dive informs us
    • “Regional health system Atrium Health [headquartered in Charlotte, NC] is partnering with tech retailer Best Buy to co-design hospital-at-home programming, bolster Atrium’s existing hospital-at-home program and sell to other hospital clients down the line.
    • The partnership, announced Tuesday, aims to combine Atrium’s hospital-at-home program and existing telemedicine infrastructure with Best Buy Health, the retailer’s healthcare vertical that includes care-at-home business Current Health, along with its home installation and supply chain capabilities.
    • “The Atrium and Best Buy partnership seeks to improve some aspects of hospital-at-home programs that can be particularly tricky for operators, like patient education and technology installation in the home.
  • Beckers Hospital Review tells us, “Mark Cuban Cost Plus Drug Co. has entered into an agreement with IBSA Pharma to sell Tirosint, a medication for hypothyroidism. It will be the first brand-name drug offered by Mr. Cuban’s pharmacy.”

From the medical and pharmaceutical research and studies front —

  • The Wall Street Journal relates
    • “Some doctors are urging patients to cut back their consumption of sugar substitutes as questions mount about their health effects. 
    • “In the latest study, published February in the journal Nature Medicine, Cleveland Clinic researchers found that the commonly used zero-calorie sweetener erythritol was associated with an increased risk of heart attacks, strokes and death within three years.
    • “Erythritol, a sugar alcohol produced naturally in the body, is used as a sugar substitute in low-calorie and low-carb products, often in those marketed as keto-friendly, such as ice cream, baked goods and condiments. It is also often mixed with other sweeteners. 
    • “As low-carb and ketogenic diets have grown popular, people have turned to nonsugar-sweetened products for a hit of sweetness with less sugar and carbs. Yet, researchers are warning that sugar substitutes might pose their own health concerns.”
  • Medscape considers whether Vitamin D is a viable prevention strategy for dementia.
  • The NIH Director’s Blog discusses the importance of dental/oral health care to overall health and well-being.
  • Securian Financial announced
    • “Fully 73% of Generation Z employees and 74% of Millennial employees have utilized mental health benefits offered by their employers, while 58% of Generation X employees and 49% of Baby Boomer employees have used the benefits.
    • Additionally, while 65% of Generation Z and 60% of Millennial workers say it’s “very important” for their employers to provide mental wellness benefits, just 49% of Generation X and 45% of Baby Boomer workers say the same.”
  • BioPharma Dive points out
    • “An experimental medicine for a rare blood vessel disorder [pulmonary arterial hypertension, or PAH, which is caused by a thickening of the blood vessels around the lungs] improved patients’ exercise capacity and potentially slowed the disease’s progression, according to detailed results from a late-stage clinical trial that were revealed on Monday.
    • “The drug, called sotatercept and owned by Merck & Co., was the principal prize of an $11.5 billion acquisition the pharmaceutical company negotiated more than a year ago.
    • “Data from the trial were presented at a medical conference and published in The New England Journal of Medicine. They have been highly anticipated since October when Merck said the study, dubbed STELLAR, was a success.”
  • The National Institutes of Health (NIH) announced
    • “Researchers at the National Institutes of Health show the benefits of screening adult patients in remission from acute myeloid leukemia (AML) for the residual disease before receiving a bone marrow transplant. The findings, published in JAMA(link is external), support ongoing research aimed at developing precision medicine and personalized post-transplant care for these patients.
    • About 20,000 adults in the United States are diagnosed each year with AML, a deadly blood cancer, and about one in three live past five years. A bone marrow transplant, which replaces unhealthy blood-forming cells with healthy cells from a donor, often improves these chances. However, research has shown that lingering traces of leukemia can make a transplant less effective. 
    • “Researchers in the current study wanted to show that screening patients in remission for evidence of low levels of leukemia using standardized genetic testing could better predict their three-year risks for relapse and survival. To do that, they used ultra-deep DNA sequencing technology to screen blood samples from 1,075 adults in remission from AML. All were preparing to have a bone marrow transplant. The study samples were provided through donations to the Center for International Blood and Marrow Transplant Research.

Monday Roundup

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.” 

Friday Factoids

Photo by Sincerely Media on Unsplash

Errata — In Thursday’s post, the FEHBlog’s item on the CDC action concerning Alzheimer’s Drug coverage in Medicare should say that the CDC was NOT changing its position that such coverage is limited to clinical trials.

From the No Surprises Act front, U.S. District Judge Jeremy Kernodle modified the NSA’s independent dispute resolution (IDR) arbitration rule on February 6 so it does not skew in favor of the statutory qualifying payment amount. The FEHBlog personally marked up the relevant portion of the IDR rule to show the edits. The FEHBlog, who represents health plans, does not find the edits earthshaking.

The NSA regulators sensibly told the NSA arbitration community to stop issuing arbitration awards while considering the next steps. This afternoon, the American Hospital Association tells us that an interim step was announced.

Effective Feb. 27, certified independent dispute resolution entities will resume issuing payment determinations for payment disputes involving out-of-network services and items furnished before Oct. 25, 2022, the Centers for Medicare & Medicaid Services announced. CMS has posted guidance for certified IDRs issuing payment determinations for items and services furnished before Oct. 25, 2022.
 
“The standards governing a certified IDR entity’s consideration of information when making payment determinations in these disputes are provided in the October 2021 interim final rules, as revised by the [February 2022] opinions and orders of the U.S. District Court for the Eastern District of Texas ” CMS said. [This refers to the FEHBlog’s edited portion of the IDR rule without the Judge’s Feburary 6, 2023 edits.]
 
The agency said IDRs will hold issuance of payment determinations for items or services furnished on or after Oct. 25, 2022 until the departments of Health and Human Services, Labor,The and the Treasury issue further guidance.
 

There you go.

From the public health front, the CDC’s Covid Data Tracker new cases, hospitalizations, and deaths continue their downward trend, while the CDC’s weekly interpretative review of its Covid data notes that “As of February 23, 2023, there are 67 (2.1%) counties, districts, or territories with a high COVID-19 Community Level, 655 (20.3%) with a medium Community Level, and 2,498 (77.6%) with a low Community Level [of the disease].

Sign of the times — the CDC Weekly Review is moving to a bi-weekly schedule.

The CDC’s FluView, which will shut down at the traditional end of the flu season, reports, “Seasonal flu activity is low nationally.”

Meanwhile, the Food and Drug Administration announced issuing

an emergency use authorization (EUA) for the first over-the-counter (OTC) at-home diagnostic test that can differentiate and detect influenza A and B, commonly known as the flu, and SARS-CoV-2, the virus that causes COVID-19. The Lucira COVID-19 & Flu Home Test is a single-use at-home test kit that provides results from self-collected nasal swab samples in roughly 30 minutes. 

In other public health news

  • Healio informs us
    • People with many low-risk sleep factors had reduced all-cause, CV and cancer mortality risk vs. those with one or no low-risk sleep factors, according to data slated for presentation at the American College of Cardiology Scientific Session.
    • “We saw a clear dose-response relationship, so the more beneficial factors someone has in terms of having higher quality of sleep, they also have a stepwise lowering of all cause and cardiovascular mortality,” Frank Qian, MD, an internal medicine resident physician at Beth Israel Deaconess Medical Center and a clinical fellow in medicine at Harvard Medical School, said in a press release. “These findings emphasize that just getting enough hours of sleep isn’t sufficient. You really have to have restful sleep and not have much trouble falling and staying asleep.”
  • The Washington Post reports
    • One in five Americans will experience major depressive disorder in their lifetime, and many will not find relief from current therapies. But now researchers have identified an unexpected source of the problem: inflammation.
    • Inflammation in the body may be triggering or exacerbating depression in the brains of some patients. And clinical trial data suggests that targeting and treating the inflammation may be a way to provide more-precise care.
    • The findings have the potential to revolutionize medical care for depression, an often intractable illness that doesn’t always respond to conventional drug treatments. While current drug treatments target certain neurotransmitters, the new research suggests that in some patients, depressive behaviors may be fueled by the inflammatory process.
  • The Powerline Blog shares eye-catching charts on the U.S. population’s gray wave.

From the wearables front —

  • mHealth Intelligence relates
    • In 2023, about 40 percent of U.S. adults are using healthcare-related applications, and 35 percent are using wearable healthcare devices, a new survey shows.
    • Released by Morning Consult, the survey polled 2,201 adults between Jan. 23 and Jan. 25. The results were compared to a previous Morning Consult poll conducted in December 2018 among 2,201 adults.
    • The 2023 survey shows gains in health app and wearables use. While health app use jumped 6 percentage points from 2018, wearables use increased by 8 percentage points.
    • Health app and wearables use varied across age groups, according to the survey. Forty-seven percent and 40 percent of respondents aged 18 to 34 used health apps and wearables, respectively, compared to 30 percent and 25 percent of adults over 65.
    • Of those who said they used health apps and wearables, most use them daily.
  • Bloomberg adds that “Apple Makes Major Progress on No-Prick Blood Glucose Tracking for Its Watch.” Completion of the moonshot project remains “years away.”

From the miscellany department

  • Beckers Hospital Review relies on the Harvard Business Review to identify “four measures needed to create shoppable healthcare beyond price transparency.”

Friday Factoids

Photo by Sincerely Media on Unsplash

    From the Omicron and siblings front —

    The CDC’s Covid Data Tracker shows all news cases, hospitalizations and deaths statistics trending down.

    Health Day informs us, “Natural immunity from a COVID infection confers protection on par with that from mRNA vaccines, but patients run the risk of hospitalization and death during their initial infection.”

    “The vaccines and boosters are still the safest way to acquire immunity, mainly for those who are in high-risk populations,” said study co-author Caroline Stein, a postdoctoral researcher at the University of Washington’s Institute for Health Metrics and Evaluation.

    In fact, the best protection now appears to come from “hybrid immunity,” the combination of an actual infection and vaccination, said Dr. William Schaffner, medical director of the Bethesda, Md.-based National Foundation for Infectious Diseases.

    From the public health front —

    • The CDC’s weekly Fluview reports, “Seasonal influenza activity is low nationally.”
    • The Fluview also discusses the risk that avian flu H5N1 poses to humans.
      • “The current public health threat to people from the H5N1 virus is low. The current H5N1 outbreak in poultry and birds continues to be mostly an animal health issue. However, people should avoid direct and close contact with sick or dead wild birds, poultry, and wild animals. People should not consume uncooked or undercooked poultry or poultry products, including raw eggs. Consuming properly cooked poultry, poultry products, and eggs is safe. Other preventive measures are available at Bird Flu: Current Situation Summary
    • Health Day tells us, based on a recent CDC study, that “Far too many young kids aren’t eating enough fruits and vegetables, even as they consume plenty of sugary sodas.” No bueno.
    • The Wall Street Journal considers “How Common is Depression After a Stroke? Sen. John Fetterman’s Treatment Prompts Question. Depression can often follow a major medical issue or chronic illness. Here’s what to know.”
      • “Overall, between 20% and 30% of people with a chronic illness experience depression, says Karina Davidson, a clinical psychologist and dean of academic affairs at Northwell Health’s Feinstein Institutes for Medical Research.”
    • The Mercer consulting firm explains how new approaches are filling gaps created by obstetric unit closings.
      • “As the access to obstetrics care dwindles, employers can and should be looking for additional solutions to help keep their pregnant members and their newborns healthy. Whether that’s exploring new digital tools [such as Pregnascan and HeraMED] coming to market or just expanding coverage on their health plans to include doulas, community doulas, midwives, and birthing centers, any effort will be an important step forward in the fight to reduce maternal mortality and poor health outcomes in the US.”

    From the No Surprises Act front, a colleague reminded the FEHBlog today that the deadline for health plans and air ambulance providers to submit their first NSA air ambulance report, March 31, 2023, is closing in. While the federal government has made available draft information on preparing this report, no sign of an official submission portal has appeared online. The clock continues clicking.

    From the Miscellany Department —

    • Medscape offers an excellent article on the cost of gene therapies. Remember to click pages.
    • Mercer also delves into the abortion pill coverage quandary. (While FEHB plans must cover contraceptive pills, including the Plan B pill, abortion pills are excluded from coverage unless the mother’s life would be endangered if the fetus were carried to term or when the pregnancy is the result of an act of rape or incest.”
    • The American Hospital Association puts a favorable spin on a recent CMS report on health system compliance with the federal government’s hospital pricing transparency rule.
    • CMS is pleased “to provide you with the recording (password: 4%2M!3c?) and slides of the February 9, 2023, virtual education session hosted by the CMS Office of Burden Reduction and Health Informatics on the Advancing Interoperability and Improving Prior Authorization Processes proposed rule.
      • As a reminder, we welcome your feedback on the proposed policies introduced in the CMS Advancing Interoperability and Improving Prior Authorization Processes proposed rule (CMS-0057-P). Comments must be received within the 90-day comment period, which closes on March 13, 2023. When commenting, please refer to file code: CMS-0057-P.”
    • Beckers Hospital Review reports, “The Federal Trade Commission has welcomed the State University of New York Upstate Medical University and Crouse Health System’s decision to abandon their proposed merger, which it said would have left Syracuse with just two hospital systems — Upstate and St. Joseph’s Health — and given the combined entity a 67 percent share of commercially insured inpatient services in Onondaga County.”

    Thursday Miscellany

    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

    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.”

    Monday Roundup

    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.

    Stillmost 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.

    Tuesday’s Tidbits

    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.”

    Weekend Update

    Photo by JOSHUA COLEMAN on Unsplash

    Congress will be in session this week for Committee and floor business.

    The No Surprises Act’s RxDC reporting deadline is this Tuesday, January 31, for the 2020 and 2021 reporting years. RxBenefits informs us, “Optum, Caremark, and Express Scripts have finalized their submission files and confirmed that all submissions would be completed before January 31, 2023, if not already filed.”

    From the public health front —

    • NPR Shots explains why your kids are germ vectors, albeit adorable ones.
    • Fortune Wells reports that “Researchers at the Institute of Psychiatry, Psychology & Neuroscience at King’s College London have developed a blood-based test that can detect Alzheimer’s disease up to 3.5 years before a clinical diagnosis.” This test would help people decide whether they need the new Biogen/Eisai drug assuming Medicare approves it.
    • Fortune Well also points out how employers can reduce workplace stress.
    • Kaiser Family Foundation provides us with recent upbeat data on long Covid.