Tuesday’s Tidbits

COVID-19

Tuesday’s Tidbits

David Ermer–COVID-19, COVID-19 vaccine, Electronic health records, FDA, Federal employment benefits, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the public health front

The Wall Street Journal reports

  • Americans seeking messenger RNA vaccines for Covid-19 for the first time will get one, updated shot targeting both the Omicron variant and the original strain of the virus under new moves rolled out Tuesday by federal health officials. 
  • The Food and Drug Administration also authorized a second booster of the updated shots for people at high risk of Covid-19, specifically people 65 years and older or people who have weak immune systems.
  • The agency’s actions mark the latest tweaks to Covid-19 vaccines, and could be followed up by further efforts to simplify the complicated vaccination regimen, perhaps by enshrining plans for a once-a-year shot for most people.
  • “The agency believes that this approach will help encourage future vaccination,” said Dr. Peter Marks, head of the FDA’s division that oversees vaccines. “Covid-19 continues to be a very real risk for many people, and we encourage individuals to consider staying current with vaccination.”

The U.S. Preventive Services Task Force maintained its I or incomplete grade for “visual skin examination by a clinician to screen for skin cancer in adolescents and adults.” In other words, USPSTF concluded that the current evidence is insufficient to assess the balance of benefits and harms of this screening examination.

The Department of Health and Human Services made available a readout from the Secretary’s roundtable on Black maternal health.

  • One critical action the Administration has taken to move the needle was implementing the state option to extend Medicaid’s postpartum coverage from two months to twelve months, a lifesaving opportunity made possible by President Biden’s American Rescue Plan (ARP) and made permanent by the Consolidated Appropriations Act, 2023 (CAA, 2023), which President Biden signed into law earlier this year. So far, 31 states and DC have signed on. Congresswoman Robin Kelly – who also sponsors the MOMMA’s Act, which aims to prevent maternal mortality – helped champion this extension. 
  • Participants who lead community organizations helped shine a light on what effective, scalable solutions can look like, and the outcomes speak for themselves.
  • Jennie Joseph shared that by removing barriers to care for women at higher risk for maternal mortality and morbidity, her organization has never had a mother or baby die in 25 years, and of the 1,200 patients served since 2020, only five babies were born premature.
  • Aza Nedhari remarked that her organization’s Home Visitation Program, which provides expectant and new parents with culturally congruent comprehensive home visiting services during pregnancy and postpartum, has supported over 2,000 families and has facilitated a zero percent mortality rate since 2015.

From the obesity treatment front

Healthcare Dive tells us.

  • Telehealth giant Teladoc Health is expanding its physician-based care product for employers to weight management and prediabetes, as interest explodes in drugs meant for diabetes control that are being more frequently prescribed for weight loss, resulting in nationwide shortages.
  • The medications, called GLP-1 drugs, include Novo Nordisk’s Ozempic, which has been at the center of a national conversation about health, weight loss and medication access as more people, especially celebrities, use the drug to lose weight.
  • The provider-based program, which includes access to a Teladoc-employed doctor for a personalized care plan, along with daily coaching with digital tools, will become available for diabetes prevention and weight management in the third quarter, the company told Healthcare Dive.

Beckers Payer Issues adds.

  • UnitedHealth Group CEO Andrew Witty told investors [last week] it is “good news” that there are innovations being made in weight management. 
  • “We need to get focused on the facts and reality of this marketplace. We need to really be clear about which patients really do benefit from these medicines and make sure we properly understand how they’re going to use those medicines,” Mr. Witty said. “So there’s a lot still to learn, I think, as these things progress through their final phases.”

From the interoperability front

  • HIMSS reports on its sessions held today.
  • The American Hospital Association relates.
    • About 84% of hospitals had posted a machine-readable file containing rate information by the end of first-quarter 2023, up from 65% the previous quarter, according to a report released today by Turquoise Health. The report also found that 183 commercial health insurers representing over 95% of U.S. commercially insured lives were publishing machine-readable files of their in-network negotiated rates and out-of-network allowed amounts, up from 68 in July 2022.

From the U.S. healthcare business front

  • The Wall Street Journal reports
    • Hospitals are joining the gig economy. 
    • Some of the nation’s largest hospital systems including Providence and Advocate Health are using apps similar to ride-hailing technology to attract scarce nurses. An app from ShiftKey lets workers bid for shifts. Another, CareRev, helps hospitals adjust pay to match supply, lowering rates for popular shifts and raising them to entice nurses to work overnight or holidays.
    • The embrace of gig work puts hospitals in more direct competition with the temporary-staffing agencies that siphoned away nurses during the pandemic. The apps help extend hospitals’ labor pool beyond their employees to other local nurses who value the highly flexible schedules of gig work. 
    • The shift is among many ways hospitals are revamping hiring, schedules and pay to give nurses more control and to fill staffing gaps created by persistent labor shortages. Vacancies are straining many hospitals’ operations despite recent hiring gains at hospitals and reports of softer demand from some temporary-staffing companies.
  • Healthcare Dive informs us
    • Pharmacists are arguing they should play a more active role in care teams by being allowed to practice the full scope of their license, according to comments at the HIMSS conference in Chicago.
    • Nearly half of U.S. counties have shortages of primary care providers, with just one of those doctors for every 1,500 people, while 61% of those counties have a high volume of retail pharmacy locations that could help make up the deficit, according to new data from health IT network Surescripts.
    • But pharmacists at HIMSS say they need access to a greater range of medical data to get there.
  • OPM held a session on this topic on the first day of its FEHB carrier conference on March 29.
  • Beckers Payer Issues reports
    • CVS Health has named Brian Kane as executive vice president and president of Aetna, effective September 1.
    • Mr. Kane will report directly to CVS President and CEO Karen Lynch. He is replacing Daniel Finke, who is stepping down for health reasons, according to an April 17 news release.

From the tidbits/miscellany department

  • The National Association of Letter Carriers calls attention to the fact that the Postal Service has issued Postal Service Health Benefits Program fact sheets for Postal employees and annuitants.
  • The Drug Channels blog makes ten predictions about how the Inflation Reduction Act will impact market access and drug channels.
  • Govexec predicts expanded childcare options and higher pay for childcare workers based on an executive order that the President signed today.

Weekend Update

David Ermer–Congress, End of the PHE, NE, Medical / Rx research, OPM, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

The Senate and the House of Representatives return to Washington, DC for Committee business and floor voting tomorrow.

On Thursday, April 20, OPM will hold the postponed second day of the OPM AHIP FEHB Carrier Conference. Of course, the FEHBlog will be in attendance.

Federal News Network tells us

  • “Just 19 of the 74 agencies in the 2022 Best Places to Work in the Federal Government rankings either held steady or improved their employee engagement score.
  • “But among many declining trends in the Partnership for Public Service’s results, some agencies still managed to shine.
  • “When we look at these averages, I think it’s so much more powerful when we pull apart and look at the variation across government and within agencies,” said Max Stier, the Partnership’s president and CEO, at a Best Places to Work ceremony Wednesday.”

From the regulatory front, the Department of Health and Human Services announced its plan to continue PREP Act liability protections related to Covid testing, preventive services and treatments well beyond May 11.

From the U.S. healthcare business front

  • Beckers Payer Issues lists 100 things to know about the Blue Cross Blue Shield system.
  • The Wall Street Journal reports “Merck & Co. said it agreed to acquire Prometheus Biosciences Inc. for $10.8 billion, a push into the lucrative market for immune-disease treatments.”
  • Healthcare Dive discusses the financial condition of non-profit hospitals.

From the medical research front, The Wall Street Journal informs us

  • “Moderna Inc. and Merck & Co.’s cancer vaccine helped prevent relapse for melanoma patients, results from a midstage trial showed, demonstrating progress in the pursuit of shots to ward off cancer by jump-starting the immune system. 
  • “About 79% of high-risk melanoma patients who got the personalized vaccine and Merck’s immunotherapy Keytruda were alive and cancer-free at 18 months, compared with about 62% of patients who received immunotherapy alone, researchers said Sunday. The 157-person trial offers some of the strongest evidence yet that such vaccines could benefit cancer patients. 
  • “I am fairly encouraged that this will open up a whole new set of trials,” said Jeffrey Weber, the senior investigator on the trial and deputy director of the Perlmutter Cancer Center at NYU Langone Health.”

From the artificial intelligence front, NPR discusses efforts to use AI to improve a volunteer driven app for the visually impaired called Be My Eyes.

  • “Hans Jørgen Wiberg, a Danish furniture craftsman, created the app after he got tired of calling his friends and family to ask for help identifying things. (Wiberg is visually impaired.) He spent a couple years developing it, and the app launched in 2015. 
  • “But eight years later, there’s a twist. As artificial intelligence, or AI, becomes more accessible, app creators are experimenting with an AI version using tech as well as human volunteers. Be My Eyes CEO Mike Buckley says the argument for AI is that it can do things people cannot. 
  • “What if the AI ingested every service manual of every consumer product ever?,” says Buckley. “And so you could tap into the AI and say, ‘How do I hook up my Sony stereo?'” Furthermore, Buckley says, “we took a picture of our refrigerator and it not only told us what all the ingredients were but it told us what we could make for dinner.”

Nifty.

Fortune Well identifies “The five best supplements for healthy aging, according to a longevity expert.” The article notes “If you’ve ever walked down the supplement aisle in a pharmacy, you’ve seen the overwhelming abundance of options available for your medicine cabinet. According to the 2022 Council on Responsible Nutrition Consumer Survey on Dietary Supplements, 75% of Americans use dietary supplements, most on a regular basis.” By the way, the five best are

  • Calcium for bone strength
  • Vitamin D for immunity and bone strength
  • Probiotics for gut health
  • Magnesium for mood, and
  • Multivitamins to cover the bases.

Late Week Miscellany

David Ermer–ACA, CDC, COVID-19, FDA, No Surprises Act, OPM, Rx coverage, SCOTUS, U.S. Healthcare–
Photo by Josh Mills on Unsplash

Dear FEHBlog readers — The FEHBlog wrote a quick blog post for Thursday but overlooked hitting the publish button, so here are the two items from Thursday and the remainder from Friday.

Wednesday afternoon, the Affordable Care Act regulators issued ACA FAQ 59 about the Braidwood Management decision. The FAQs expressly endorsed OPM’s informal administration action last Friday using FEHB Act Section 8902(d) to endorse the U.S. Preventive Services Task Force recommendations that the decision rejected because they had no federal government endorsement. The FEHBlog wonders why HHS hasn’t pulled this page out of OPM’s playbook.

Wednesday night, the U.S. Court of Appeals for the Fifth Circuit (2-1 decision) stayed a portion of the abortion pill injunction on statute of limitations grounds in a 42-page opinion. The Fifth Circuit opinion allows the abortion pill to stay on the market with reinstated in-person medical visit prerequisites and without delivery by mail. The Attorney General has stated that he will ask the Supreme Court to weigh in. Axios reports that the Supreme Court would decide quickly.

Axios was correct because the Wall Street Journal reported that today

  • The Supreme Court temporarily blocked lower court orders that would have limited access to the abortion drug mifepristone beginning Saturday, preserving the pill’s availability while the justices weigh the Biden administration’s emergency request to leave current Food and Drug Administration approvals in place during a continuing legal battle with antiabortion groups.
  • In a pair of orders Friday, Justice Samuel Alito, who oversees emergency matters for the lower courts that limited or suspended approval of the widely used abortion pill, gave the antiabortion groups until noon Tuesday to file briefs in response to appeals by the FDA and Danco Laboratories LLC, which makes the branded version Mifeprex.
  • The temporary orders expire at 11:59 p.m. Wednesday, suggesting a high court decision on whether and to what extent mifepristone will remain available during litigation may come by then.

In other judicial news, the American Hospital Association informs us

  • The U.S. Supreme Court today unanimously reversed a 9th Circuit decision that impliedly stripped federal district courts of jurisdiction over constitutional challenges to the Federal Trade Commission structure, procedures and existence. Ruling in the FTC case and another case involving the Securities and Exchange Commission, the Supreme Court said, “The statutory review schemes set out in the Securities Exchange Act and Federal Trade Commission Act do not displace a district court’s federal-question jurisdiction over claims challenging as unconstitutional the structure or existence of the SEC or FTC.”
  • As a result of this decision, parties may bring claims in federal court alleging that “the structure, or even existence, of an agency violates the Constitution” without having to first go through costly and time-consuming administrative proceedings before the SEC or FTC.

Turning now to the federal employment front –

  • Govexec tells us
    • Office of Management and Budget guidance released Thursday tasks agencies with developing a new system to monitor their “organizational health and organizational performance” on an ongoing basis. With the new system comes an expectation that federal agencies will rely less on telework and remote work, although that must be balanced with the need to compete for talent with private sector employers who continue to offer similar workplace flexibilities, wrote OMB Deputy Director for Management Jason Miller in a blog post accompanying the memo.
  • Federal News Network reports OPM’s implementation of the Postal Service Health Benefits Program.

From the public health front

  • The Centers for Disease Control begins to bring down the curtain on its now bi-weekly review of its Covid statistics and updates us on the bird flu situation.
  • The Food and Drug Administration announced granting emergency use authorization to an improved Covid test.
  • The Robert Wood Johnson Foundation offers various perspectives on achieving joyful, healthy births for all, a worthy goal.
  • Medscape identifies troubling trends in colorectal cancer data recently released by the American Cancer Society.

From the regulatory front —

  • Mercer Consulting offers advice on the recent instructions concerning RxDC reporting for the 2022 reference year due June 1.
  • Healthcare Finance tells us
    • The Office of Civil Rights is providing a 90-day transition period for healthcare providers to come into compliance with the HIPAA Rules regarding telehealth, according to the Department of Health and Human Services OCR. 
    • The transition period will be in effect beginning on May 12 and will expire at 11:59 p.m. on August 9.
    • OCR said it would continue to exercise its enforcement discretion and not impose penalties on covered providers for noncompliance during the 90- day transition period. 
    • During the public health emergency, providers did not have to be licensed in the state where the patient was located. They were allowed to treat patients in other states. 
    • Also, under the PHE, non-HIPAA-compliant platforms were allowed as long as they were not public facing.
    • Both of these flexibilities are coming to an end with the PHE on May 11, with providers now getting a 90-day grace period.
    • Other telehealth provisions expire at the end of 2023 and 2024

From the Rx coverage front —

  • Fierce Healthcare informs us that Cigna’s Express Scripts unveiled two new programs on Thursday, Copay Assurance and ClearCare Rx, which reminds the FEHBlog of OPM’s transparent pharmacy pricing program.
  • The Institute for Clinical and Economic Research (ICER) published an
    • Evidence Report on Treatments for Non-Alcoholic Steatohepatitis [liver inflammation]
      • — Evidence suggests that both resmetirom and obeticholic acid improve liver histology without evidence yet demonstrating improved long-term outcomes; obeticholic acid has more concerning side effects —
      • — Current evidence suggests that resmetirom would achieve common thresholds for cost-effectiveness if priced between $39,600 – $50,100 per year, while obeticholic acid would achieve these thresholds if priced between $32,800-$40,700 per year —
      • — At the April 28 virtual public meeting, ICER’s independent appraisal committee will review the evidence, hear further testimony from stakeholders, and deliberate on the treatments’ comparative clinical effectiveness, other potential benefits, and long-term value for money —

From the U.S. healthcare business front

  • Beckers Payer Issues reports, “UnitedHealth Group posted revenues of $91.9 billion in the first quarter of 2023, up 15 percent from $80.1 billion over the same period last year, according to the company’s earnings report released April 14.”
  • Beckers Hospital Review ranks 29 physician specialties by annual compensation.

Tuesday’s Tidbits

David Ermer–End of the PHE, NE, Medicare, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From the U.S. healthcare business front —

  • STAT News reports
    • “UnitedHealth Group has acquired Crystal Run Healthcare, a prominent physician group in New York.
    • “The deal for Crystal Run, a network of almost 400 doctors, nurse practitioners, and other clinicians, closed in late February. There was no fanfare. Neither company issued a press release. The deal only came to light from an email obtained by the Mid-Hudson News.
    • “The move brings yet another large group of providers into UnitedHealth, which had more than 70,000 employed clinicians at the end of 2022. UnitedHealth is most-known for its health insurance arm, UnitedHealthcare. But the company has made a concerted effort over the past several years to buy physician groups, surgery centers, and other outpatient providers, and then funnel its insurance members to those entities as a way to keep more of the insurance premiums.”
  • Health Payer Intelligence tells us “58% of Payers Use Outcomes-Based Contracts for Prescription Drugs; While 10 percent of payers had between two and five outcomes-based contracts in place in 2022, 35 percent had 10 or more contracts.”
  • Fierce Healthcare relates “Evernorth’s Accredo specialty pharmacy arm has rolled out a new program that aims to assist members and plan sponsors in better managing the cost and complexity of therapies for rare conditions.”
  • Health Payer Intelligence reports
    • “Aetna launched a partnership with a virtual care company to provide chronic disease management for members with digestive issues.
    • “Aetna’s partner offers a virtual care platform dedicated to digestive health called Oshi.
    • “Oshi’s virtual-first, integrated approach to GI care aligns with our mission to invest in companies that are improving health for more people,” said Vijay Patel, managing partner at CVS Health Ventures. “Our collaboration with Oshi is a powerful example of how our investments in high-potential, early-stage companies are helping to make consumer health care more accessible, affordable and simpler.”
  • STAT News helpfully delves into the topic of how much a Medicare increase do hospitals need for the next federal fiscal year? It’s an enlightening read.

Sermonette — The squib from the lead story about UHG’s acquisition of Crystal Run ends with a cheap shot at the profit motive. As the FEHBlog noted at the time the ACA imposed the medical loss ratio on insurers, insurers will find a way to circumvent the MLR with other products which are not so limited. In this case, UHG has pulled a page out of Kaiser Permanente’s successful and admirable approach of pairing a medical group with a health plan to improve healthcare quality over time. Both the profit motive and the achieving quality goals underlie these business combinations, which the ACA’s MLR and other features invented.

From the end of the public health emergency front, the American Hospital Association informs us

  • “HIPAA enforcement discretion implemented for the COVID-19 public health emergency will expire with the end of the PHE on May 11, but covered health care providers will have until Aug. 9 to comply with the HIPAA rules with respect to telehealth, the Department of Health and Human Services’ Office for Civil Rights announced today.”
  • “OCR is continuing to support the use of telehealth after the public health emergency by providing a transition period for health care providers to make any changes to their operations that are needed to provide telehealth in a private and secure manner in compliance with the HIPAA Rules,” explained OCR Director Melanie Fontes Rainer.
  • “OCR in 2020 implemented enforcement discretion policies under HIPAA and the Health Information Technology for Economic and Clinical Health Act for community-based testing sites; telehealth remote communications; use and disclosure of protected health information by business associates; and online scheduling for COVID-19 vaccination.”

Here is a link to the notice.

From the COB with Medicare front, here is a link to a March 29 CMS Webinar for group health plans on Section 111 compliance. Speaker notes can be found at the end of the slides.

Monday Roundup

David Ermer–End of the PHE, NE, Medicare, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the end of the PHE/National Emergency (NE) front, yesterday President Biden signed into law a bill (HR 7) that ends the Covid NE immediately, instead of May 11, as the Administration planned. In addition, the NE law calls for a 60-day phase-out period following termination. Consequently, the statutory changes tied to the NE end will phase out on June 7, 2023.

The statutory changes about employer-sponsored health plans falling into this category directly impact employers and concern topics, e.g., COBRA continuation coverage and ERISA appeal rights, that do not affect FEHBP.

In contrast, the statutory changes tied to the end of PHE, e.g., no-cost Covid testing, preventive services etc., do not impact FEHB plans. The available guidance on that matter is found in ACA FAQ 58.

From the post-Dobbs front, the Wall Street Journal reports

  • “The Biden administration filed an emergency request Monday asking a federal appeals court to block a ruling that suspended approval of a widely used abortion pill, while some Democratic-led states announced contingency plans to stockpile abortion drugs.
  • “In a filing with the New Orleans-based Fifth U.S. Circuit Court of Appeals, the Justice Department said a federal judge in Texas engaged in an “extraordinary and unprecedented” usurpation of the U.S. Food and Drug Administration’s authority by ruling that the pill shouldn’t have been approved. 
  • “The department said U.S. District Judge Matthew Kacsmaryk in Amarillo, Texas, upended decades of reliance on the abortion pill, known as mifepristone, “based on the court’s own misguided assessment of the drug’s safety.”
  • “The drug’s brand-name manufacturer, Danco Laboratories, which sells mifepristone marketed as Mifeprex, filed a similar motion. The company said that in addition to the potential harm the ruling posed to millions of women who rely on the pill, it also threatened Danco’s livelihood as a one-drug company. 
  • “Hundreds of pharmaceutical industry leaders, meanwhile, weighed in, saying in an open letter that the Texas decision could threaten FDA regulation of medicines more broadly.”

From the Medicare front, Fierce Healthcare informs us

  • “The Centers for Medicare & Medicaid Services (CMS) released the proposed Inpatient Prospective Payment Systems (IPPS) rule and the Long-Term Care Hospital pay rule. In addition to changes to payment rates, the agency is proposing to measure hospitals on how they tackle health equity. 
  • “CMS is helping to build a resilient healthcare system that promotes good outcomes, patient safety, equity and accessibility for everyone,” said CMS Administrator Chiquita Brooks-LaSure in a statement. 
  • “Hospitals that participate in the IPPS Quality Reporting Program and meaningfully use electronic records are projected to get a 2.8% increase to payments for fiscal year 2024, which begins in October. The pay raise is based on a 3% projected hospital market basket update of 3%, which is “reduced by a projected 0.2 percentage point productivity adjustment,” according to a release on the rule. 
  • “Overall, this will lead to a $3.3 billion increase in inpatient payments. However, long-term care hospitals are expected to get reduced payments by 2.5%, or $59 million.
  • “Overall, CMS expects [long-term care] payments under the dual-rate payment system to decrease by 0.9%, or $24 million, primarily due to a projected decrease in high-cost outlier payments in FY 2024 compared to FY 2023,” the agency said.”
  • Hospital groups slammed the proposed payment rates for the IPPS and long-term care hospitals as inadequate.

From the Postal Service front, Federal News Network tells us that USPS marked the first anniversary of the Postal Reform Act by proposing a price increase on stamps for the summer of 2023.

  • “The agency announced Monday that it plans to raise rates again. The proposed rates would go into effect on July 9, and would raise the price of a first-class stamp to 66 cents.
  • “USPS said operating expenses fueled by inflation continue to rise, and that the agency making up for years of operating under a “defective pricing model.”
  • “USPS raised the price of a first-class stamp to 63 cents in January, after raising it from 58 cents to 60 cents in July 2022.”

In consumer health news, the Wall Street Journal discusses the impact of the new generation of weight loss drugs on the $76 billion diet industry and offers guidance on buying lower-priced hearing aids over the counter. Interesting tidbit, most OTC hearing aids include useful customer support.

Friday Factoids

David Ermer–ACA, CDC, COVID-19, FDA, Federal employment benefits, OPM, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

Happy 75th World Health Day!

OPM announced

Voice of America’s Asian American Changemakers series premiered its final episode recently, featuring the work of the U.S. Office of Personnel Management and the leadership of Director Kiran Ahuja. Asian American Changemakers is a character-driven docuseries highlighting the lives and experiences of Asian Americans in the political and public arena.  * * *

Watch the full Asian American Changemakers episode here and learn more about opportunities to serve at opm.gov.   

OPM also informed FEHB carriers that “The recent opinion in Braidwood Management, Inc. v. Becerra, — F. Supp. 3d —, 2023 WL  2703229 (N.D. Tex.), in the U.S. District Court for the Northern District of Texas, pertains to the preventive services requirement under the Affordable Care Act; it does not impact the preventive services requirements for FEHB Carriers.”  Regardless, and as the FEHBlog anticipated, writers in Health Affairs suggest sensible administrative law approaches to repairing the Braidwood management problem. For example, “the HHS Secretary could authorize the director of the Agency for Health Care Research and Quality or the CDC director to review and adopt the Task Force’s recommendations, which the CDC director now does before ACIP’s immunization recommendations become effective.” No wonder HHS appealed Braidwood Management to the Fifth Circuit without requesting a stay of the district court’s decision.

In other judicial news, the Washington Post reports

  • “A federal judge in Texas blocked U.S. government approval of a key abortion medication Friday, siding with abortion foes in an unprecedented lawsuit and potentially upending nationwide access to the pill widely used to terminate pregnancies.
  • “The highly anticipated ruling puts on hold the Food and Drug Administration’s approval of mifepristone, a medication first cleared for use in the United States in 2000. The ruling will not go into effect for seven days to give the government time to appeal.”

Later today, per the AP, “A federal judge in Washington state on Friday ordered U.S. authorities not to make any changes that would restrict access to the abortion medication mifepristone in 17 Democratic-led states that sued over the issue, countering a ruling by a judge in Texas on the same day that ordered a hold on federal approval of the drug.”

From the healthcare of the near future front —

  • Medscape relates
    • “US regulators may soon clear blood-based biomarker tests for colorectal cancer (CRC), expanding potential options for patients seeking more convenient forms of screening.
    • “Most recently, Guardant Health, Inc., announced the completion of its US premarket approval application for its Shield blood test to screen for CRC. Approval by the US Food and Drug Administration (FDA) would position Guardant to later secure Medicare coverage for its test.
    • “Rival companies, including CellMax Life, Freenome, and Exact Sciences, which already offers the stool-based Cologuard product, are pursuing similar paths in their development of blood tests for CRC.
    • I”f these companies succeed, clinicians and patients could have a choice of several FDA-approved tests in a few years.”
  • A Wall Street Journal essay digs into why “doctors are turning to artificial intelligence to help them make the best decisions for patients.

From the public health front –

  • Fierce Healthcare informs us “Black mothers living in the least vulnerable areas of the U.S. are more likely to die or have worse birth outcomes compared to white mothers living in the most vulnerable areas, a sweeping new study has found.”
  • Fierce Healthcare tells us “Reports of serious patient safety events among healthcare facilities in 2022 rose 19% from 2021 with falls, the most common such event, rising nearly 27%, according to data reported to The Joint Commission and released Tuesday.”

Thursday Miscellany

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

Today is National Employee Benefits Day, a celebration created by the International Foundation of Employee Benefit Plans.

From inside the Capital Beltway —

  • OPM issued a press release on its interim final rule concerning Postal Service Health Benefits Program implementation. That IFR was published in the Federal Register today.
  • Federal News Network reports that members of Congress are pressuring OPM to fix the consistent delays in processing federal employee retirement applications. The straightest path to solving the delay problem is reconfiguring or replacing the current Federal Employee Retirement System that replaced an even more complex Civil Service Retirement System prospectively in the mid-1980s. That is Congress’s responsibility.
  • Govexec tells us that “The Internal Revenue Service will bring on about 30,000 employees over the next two years as it begins spending the $80 billion in new funds Congress provided last year, the Biden administration said in an operational plan it unveiled on Thursday.”
  • Govexec further informs us that
    • On Thursday, President Biden signed an executive order to improve the effectiveness of the regulatory review process and regulatory analysis, which implements his Day One memo.
    • “Parts of the federal regulatory review process haven’t been updated since the 1990s, and since then, we’ve seen substantial advances in scientific and economic knowledge,” wrote Richard Revesz, administrator of the Office of Information and Regulatory Affairs, in a blog post. “These new steps will produce a more efficient, effective regulatory review process that will help improve people’s lives—from protecting children from harmful toxins and lowering everyday costs for families to improving rail safety and growing our economy from the middle out and bottom up.”

From the Rx and medical devices coverage front

  • Fierce Healthcare reports
    • Health and Human Services’ highly publicized list of the first Medicare Part B prescription drugs hit with rebates under the Inflation Reduction Act discreetly dropped from 27 to 20, prompting critiques from the pharma lobby over the Biden administration’s swift implementation of the legislation’s drug controls.
    • As spotted by Endpoints, the press release and accompanying guidelines released by HHS were updated on March 30 with the removal of several previously listed drugs: Gilead’s Yescarta and Tecartus, Bausch + Lomb’s Xipere, Acrotech Biopharma’s Folotyn, Shionogi’s Fetroja, Kamada’s WinRho and Stemline Therapeutics’ Elzonris.
  • MedTech Dive reports
    • Abbott has initiated a recall for [4.2 million] reader [devices] for its FreeStyle Libre glucose monitoring systems, which are at risk of catching fire if improperly stored or charged, according to the Food and Drug Administration. 
    • The agency categorized the recall as Class I, the most serious category of problems with medical devices, which can cause serious injury or death. Abbott noted that users do not need to send the devices back to the company but can continue to use them as long as they use chargers and cables supplied by Abbott with the device. * * *
    • The company has set up a special website with more information for people who use the FreeStyle glucose readers.
    • Abbott said that users can replace the reader with a smartphone app. 
  • Beckers Hospital Review relates
    • The FDA withdrew its approval of Makena, the only preterm birth drug greenlit by the agency, on April 6 after research showed the treatment did not work better than a placebo. 
    • The repealed approval follows an FDA advisory panel voting in favor of removing Makena and the drugmaker announcing it would halt sales. 
  • Beckers Pharmacy News tells us
    • Mark Cuban Cost Plus Drug Co. now sells more brand-name drugs. 
    • After breaking into the brand-name market in March — over a year since launching its online wholesaler company — Cost Plus Drugs offers three brand-name products made by Janssen, a Johnson & Johnson business. Cost Plus Drugs sells about 1,000 generics and four brand-name drugs. 
    • The three products are Invokana (canagliflozin), Invokamet (canagliflozin-metformin HCl) and Invokamet XR (canagliflozin-metformin HCl), according to a Cost Plus Drugs tweet.
    • One of them, Invokana, is a Type 2 diabetes drug that typically costs more than $675, according to Cost Plus Drugs’ website. Mr. Cuban’s company’s price is $243.90. 

From the public health front —

  • JAMA announced the following study results
    • In the first year of the COVID-19 pandemic, 2 US studies suggested that people hospitalized for COVID-19 had nearly 5 times the risk of 30-day mortality compared with those hospitalized for seasonal influenza.1,2 Since then, much has changed, including SARS-CoV-2 itself, clinical care, and population-level immunity; mortality from influenza may have also changed. This study assessed whether COVID-19 remains associated with higher risk of death compared with seasonal influenza in fall-winter 2022-2023.
    • [Based on an examination of Veterans Administration electronic health records] there were 8996 hospitalizations (538 deaths [5.98%] within 30 days) for COVID-19 and 2403 hospitalizations (76 deaths [3.16%]) for seasonal influenza (Table). After propensity score weighting, the 2 groups were well balanced (mean age, 73 years; 95% male).
    • The death rate at 30 days was 5.97% for COVID-19 and 3.75% for influenza, with an excess death rate of 2.23% (95% CI, 1.32%-3.13%) (Figure). Compared with hospitalization for influenza, hospitalization for COVID-19 was associated with a higher risk of death (hazard ratio, 1.61 [95% CI, 1.29-2.02]).
    • The risk of death decreased with the number of COVID-19 vaccinations (P = .009 for interaction between unvaccinated and vaccinated; P < .001 for interaction between unvaccinated and boosted). No statistically significant interactions were observed across other subgroups 
  • The U.S. Preventive Services Task Force released its final research plan for “Vitamin D, Calcium, or Combined Supplementation for the Primary Prevention of Falls and Fractures in Community-Dwelling Adults: Preventive Medication.”
    • Community-Dwelling means “Community and primary care–relevant settings, including assisted and independent living facilities,” but not inpatient, SNF, or rehabilitation settings.

From the healthcare spending front —

  • Health Payer Intelligence reports
    • The average out-of-pocket spending per non-birth-related pediatric hospitalization was $1,313 for privately insured children, but spending varied depending on the time of the year, chronic condition prevalence, and plan generosity, a study published in JAMA Pediatrics found.
    • Non-birth-related pediatric hospitalizations occur 2.5 million times per year and can lead to high medical costs for privately insured families.
    • Researchers used claims data from 2017 to 2019 from the IBM MarketScan Commercial Database to assess out-of-pocket spending for these hospitalizations and which factors influence this spending.
  • Aon released on April 5
    • findings showing more U.S. employers are looking to steer employees to affordable, quality care options as a way to combat rising medical costs and improve health outcomes.
    • Aon’s 2022 Health Care Survey outlines employer priorities in health and benefits strategies and shows how they are responding to looming health care inflation, which Aon forecasts to rise 6.5% this year to more than $13,800 per employee on average.
    • Data show employers are eager to steer participants toward high-quality, cost-effective hospitals and physicians using a combination of narrow network strategies, plan design, provider guidance services and financial incentives. Thirty-seven percent of employers said they were interested in using plan design to steer members to optimal providers, while 35% already have these plan design features in place.
  • Fierce Healthcare interviews a WTW expert about ways employers can control rising healthcare costs.
    • Last June, the major tracker of inflation—the Consumer Price Index—hit 9.1% but has been receding ever since. Employers should be aware that the healthcare industry will not see a similar reduction in prices and, in fact, should expect costs to rise substantially, according to an expert at Willis Towers Watson.
    • Tim Stawicki, a WTW senior health and benefits consultant, said in a recent blog post that a different dynamic will function in the healthcare industry because contracts lock in negotiated prices, usually for one to three years.
    • When those contracts end, providers will want to make up for profits they may feel that they missed out on, and that’s especially the case in the wake of the COVID-19 pandemic. * * *
    • Stawicki advised employers that they can avoid the worst of this fallout through better management of utilization and reviewing physician networks to make sure that they coincide with an employer’s coverage area that may have changed because of COVID-19. In addition, employers should try to improve the employee experience and implement more cost-effective points of care by steering individuals to urgent care centers or making it easier to use virtual care and choose provider networks based on their geographic footprint.

Midweek Update

David Ermer–CMS, COVID-19, Federal employment benefits, Medicare, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Manasvita S on Unsplash

Govexec and the Federal Times report about yesterday’s release of OPM’s Postal Service Health Benefits Program interim final rule.

Fedweek offers interesting observations on the federal workforce demographics:

“For years, [federal agencies] focused on the “retirement wave”—or still more sweeping, the “retirement tsunami”—when the Baby Boom population hit retirement eligibility. That view continues today, with the constant repetition of statistics such as that 15 percent of the federal workforce is already eligible to retire, and that in five years 30 percent of current employees will be eligible.

“That wave never happened and there is no reason to believe it will.

“What has actually happened is that federal retirements have been a fairly steady flow at around 60,000 to 70,000 each year from agencies apart from the Postal Service (which accounts for about 40,000 more on average). That’s around 3 percent per year, so when it’s five years later, 15 percent or so already have retired and there’s still only 15 percent who are eligible.

“Since those first soundings about a retirement wave, the workforce actually has been increasing in age. The average is now 47—five years older than the overall U.S. workforce—with about 28.7 percent age 55 or above, up by a half-point just in the last six years. The percentage aged 60 and older—which more or less equates to retirement eligibility—rose from 9.4 to 14.5 percent over the last 15 years.”

This is the demographic challenge facing the FEHB Program which is ameliorated by the coordination of benefits with Medicare beginning at age 65. OPM improved the opportunities for coordination of benefits with Medicare by allowing carriers to integrate Medicare Part D prescription drug plans for 2024.

From the public health front —

  • Dana Farber Cancer Institute offers insights into which States have the highest cancer rates.
  • The Department of Human Services announced making progress in the “whole of government” response to long Covid.

“[E]xperts say there is little public awareness about CMV compared to other viral infections that can infect a fetus in utero, such as HIV, Zika, and toxoplasmosis, all of which are far rarer than CMV infections. Professional societies recommend pre-pregnancy counseling and monitoring for HIV, but not for CMV. And testing for the infection in newborns isn’t widespread.”[E]xperts say there is little public awareness about CMV compared to other viral infections that can infect a fetus in utero, such as HIV, Zika, and toxoplasmosis, all of which are far rarer than CMV infections. Professional societies recommend pre-pregnancy counseling and monitoring for HIV, but not for CMV. And testing for the infection in newborns isn’t widespread.

“Through my entire career, it’s been so clear that this field is really lacking in progress,” said Laura Gibson, an infectious diseases physician at UMass Memorial Health. “It’s just been frustrating to all of us in the field over decades.”

“That is starting to change, as state public health committees and legislatures begin to debate whether to mandate doing more robust screening for CMV. In 2019, Ontario became the first region in the world to test every baby for CMV. This year, Minnesota followed suit.”

“Obesity and diabetes in mothers have traditionally been considered risk factors for the child to also develop obesity. But a new study suggests that more narrow measures of health during pregnancy could help better assess that risk.

“Researchers grouped pregnant women based on specific metabolic traits and found that insulin resistance was associated with the highest risk, compared with other traits such as high cholesterol and triglycerides, according to a study published in JAMA Network Open on Tuesday.

“The risk linked to insulin resistance was even higher than that associated with prepregnancy obesity, defined as a body mass index over 30, and with diabetes diagnosed in gestation, the study said.”

From the Rx coverage front —

  • AHIP offers a new resource that “highlights how biosimilars offer an effective, lower-cost alternative to a brand name biologic product. In the last 10 years, for example, $36 billion of biosimilar medication spending was associated with $56 billion in savings. And savings from biosimilars are expected to exceed $180 billion over the next 5 years — a more than 4-fold increase from the last 5 years.”
  • STAT News reports on cancer drug shortages that have plagued our country for years.

From the telehealth front, mhealth intelligence informs us that “According to the FAIR Health Monthly Telehealth Regional tracker, telehealth use increased [7.3%] across the country in January, with rates rising at the national level and in all US Census regions.” My word, telehealth use increased in the winter?!?

Finally, in Medicare Advantage and Part D News, CMS lowered the boom on Medicare Advantage and Part D plans with a new final rule to “strengthen Medicare Advantage and hold health insurance companies to higher standards for America’s seniors and people with disabilities by cracking down on misleading marketing schemes by Medicare Advantage plans, Part D plans and their downstream entities; removing barriers to care created by complex coverage criteria and utilization management; and expanding access to behavioral health care.” This action follows a payment policy and risk adjustment rule compromise last week.

PSHBP IFR Released

David Ermer–CMS, COVID-19 vaccine, Medicare, OPM–

This afternoon, OPM’s Postal Service Health Benefits Program Interim Final Rule was timely posted on the Federal Register’s website. The FEHBlog estimates that deadline for public comment on the rule is Monday June 5, 2023.

From the Omicron and siblings front, Becker’s Hospital Review tells us

“The FDA is planning to make another COVID-19 booster that targets omicron available for high-risk individuals, The Washington Post reported April 3.

“Under the authorization, people 65 and older and those with weakened immune systems would be eligible to receive a booster dose four months after their last bivalent shot.

“The policy will be “permissive,” meaning the agency will allow people to get another booster but will not definitively recommend it, sources familiar with the matter told the Post.

“The FDA is expected to announce the plan within several weeks, and the CDC is expected to quickly endorse it, sources said. “

From the anomalies front, Fierce Healthcare informs us

“Cash prices for certain hospital services were lower than the average insurance rate in nearly half of the facilities examined in a new study, which could influence rate negotiations between payers and providers. 

“The study was published Monday in the journal Health Affairs and makes use of cash price data hospitals are required to disclose for 70 shoppable services. The findings suggest that some self-insured employers pay prices higher than the cash price, which could influence future negotiations with insurers or direct talks with providers. 

“Researchers looked at the cash prices, commercial negotiated rates and chargemaster prices disclosed by 2,379 hospitals as of Sept. 9, 2022, per a federal rule that went into effect in 2021.

“The average and the median cash price made up 64% and 65% of the chargemaster rate.

“About 12% of the cash prices were set the same as chargemaster rates, and other cash prices were predominantly priced in increments of 5% off the chargemaster rates (64% of the time),” the study said. 

“The study found that the cash prices were lower than the median commercial rates in 47% of cases, most often at hospitals with government or nonprofit ownership, located outside of metropolitan areas or located in counties with relatively high uninsurance rates or low median household incomes.

“Researchers also discovered that evaluation and management services were the most likely to have a lower cash price with 55% compared with medicine and surgery at 48%.”

From the Medicare Advantage front, Healthcare Finance confirms

“Health insurers and stakeholders have expressed support for the Centers for Medicare and Medicaid Services’ plan to phase in changes to the risk adjustment model over three years, in the 2024 Medicare Advantage Program and Part D Payment Policies released Friday.

“The model changes will begin in 2024, with the full brunt of phased-in risk adjustment to take effect in 2026, according to Susan Dentzer, president and CEO of America’s Physician Groups.

“We’re satisfied with this,” said Ms. Dentzer. “They mostly listened.”

“Insurers also voiced their support for the payment increase in the 2024 Medicare Advantage and Part D Rate Announcement.

“CMS anticipates a payment increase for Medicare Advantage plans of 3.32% from 2023 to 2024 as a result of various changes, including in risk adjustment.

“This compares to the 1.03% increase in revenue proposed in the 2024 Advance Notice released in February.”

“We appreciate that CMS recognized the serious concerns with several proposed policies in the Advance Rate Notice that would affect MA enrollees in 2024, including by phasing in changes over a period of three years,” said Matt Eyles, president and CEO of AHIP.

Monday Roundup

David Ermer–CDC, COVID-19, FDA, Rx coverage–
    Photo by Sven Read on Unsplash

    From the Omicron and siblings front, Kaiser Family News reports

    More than three years into the COVID-19 pandemic, about half (53%) the public says they would likely get an annual COVID-19 vaccine if offered similar to an annual flu shot, the latest KFF COVID-19 Vaccine Monitor finds. This includes about a third (32%) who would be “very likely” to do so.
    The findings provide a window into the potential uptake of an annual COVID-19 vaccine, which the Food and Drug Administration has raised as a potential option to provide future protection from the virus. 

    * * *

    • Nearly a quarter (23%) of adults say they’ve gotten the latest bivalent COVID-19 booster, which has been available since September. Similar shares say they have received an earlier booster shot (25%) or have gotten their initial course of vaccinations but no booster (25%). That leaves slightly more than a quarter (27%) who say that they are either partially vaccinated or not vaccinated at all.
    • Half (49%) of adults say they’ve heard at least something about the Biden administration’s plan to end the COVID-19 public health emergency on May 11.

    * * *

    Nearly a third (32%) of all adults nationally say they have never tested positive for COVID-19 or never thought they’ve had the virus, and the new survey examines their experiences. This never-had-it group includes nearly half (46%) of adults ages 65 and older, who generally had earlier access to the vaccines due to their high risks.

    In other public health news

    • “The U.S. Department of Health and Human Services (HHS) released a National Cancer Plan, developed by the National Institutes of Health’s (NIH) National Cancer Institute (NCI). The plan provides a framework for everyone—across the federal government and all of society—to collaborate in ending cancer as we know it, and to realize the vision laid out by President Joe Biden and First Lady Jill Biden’s Cancer Moonshot.”
    • Reuters informs us
      • “The U.S. National Institute on Aging (NIA) is funding a 6-year, up to $300 million project to build a massive Alzheimer’s research database that can track the health of Americans for decades and enable researchers to gain new insights on the brain-wasting disease.
      • “The NIA, part of the government’s National Institutes of Health (NIH), aims to build a data platform capable of housing long-term health information on 70% to 90% of the U.S. population, officials told Reuters of the grant, which had not been previously reported.”
    • Bloomberg Prognosis looks back at the perfect storm of serious ailments that afflicted children worldwide last year. The culprit was socially distancing the kids.

    In FDA and drug development news

    • BioPharma Dive points out five FDA drug decisions to watch for in this quarter. “By the end of June, the agency could clear a gene therapy for Duchenne muscular dystrophy, two vaccines for RSV and a closely watched ALS drug.”
    • “The U.S. Food and Drug Administration announced it is requiring manufacturers of opioid analgesics dispensed in outpatient settings to make prepaid mail-back envelopes available to outpatient pharmacies and other dispensers as an additional opioid analgesic disposal option for patients.”
    • The Wall Street Journal offers a fascinating look at how Lilly reengineered its drug development business. The article explained that in the last decade, Lilly focused on non-interference with the patent status of existing blockbuster drugs, e.g., squeezing the last egg out of the golden goose. Late last decade, Lilly redirected its focus to bringing new drugs to market regardless of patent concerns. As a result, Lilly is close to receiving FDA market approval for the “King Kong” of obesity drugs Mounjaro.

    People who are overweight are flocking to the drug Ozempic to slim down. Looming is an even more powerful weight-loss treatment.

    The drug Mounjaro helped a typical person with obesity who weighed 230 pounds lose up to 50 pounds during a test period of nearly 17 months. 

    No anti-obesity drug has ever safely made such a difference. In the coming months, it is widely expected to get the go-ahead from U.S. health regulators to be prescribed for losing weight and keeping it off, and some patients are already using it unapproved for that purpose.

    The advance of Mounjaro, which is already on the market to treat Type 2 diabetes, has excited doctors and patients who have been waiting decades for effective treatments, while helping turn its maker, Eli Lilly & Co., into the most valuable standalone pharmaceutical company in the U.S. with a market value of more than $300 billion.