Tuesday Tidbits

SCOTUS

Tuesday Tidbits

David Ermer–CDC, Medical / Rx research, Mental health care, NIH, Rx coverage, SCOTUS, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC —

  • The U.S. Supreme Court released three more opinions this morning. The Wall Street Journal reports
    • “The Supreme Court rejected a bid by Norfolk Southern to limit its state-court liability in states where it does relatively little business, ruling Tuesday that states can require companies to submit to their courts’ jurisdiction as a condition of doing business within their borders.
    • “While the case involved a long-pending workplace lawsuit filed by a retired railway employee from Virginia, Justice Neil Gorsuch, writing for a 5-4 majority of the justices, linked the issue to a Norfolk Southern train’s Feb. 3 derailment in East Palestine, Ohio.”
  • The Supreme Court has pending seven more decisions from its October 2022 term. The next decision day will be Thursday morning.
  • Beckers Hospital Review tells us,
    • “The Federal Trade Commission has proposed changes to the premerger notification form in addition to premerger notification rules implementing the Hart-Scott-Rodino Act, which requires organizations to report large transactions to the FTC and Justice Department for antitrust review.
    • “The HSR Act and its implementing rules related to mergers and acquisitions involve completing HSR Forms and waiting a specified period of time before completing the transaction.
    • “The proposed HSR changes would help the agencies to more effectively screen transactions for potential competition issues within the waiting period, which is generally 30 days. The FTC said that this competition review is important to identify deals that require in-depth investigations to determine whether they would violate antitrust laws and, if so, to seek to block the proposed transaction.”
  • HHS Inspector General announced posting
    • “its final rule implementing information blocking penalties. The final rule establishes the statutory penalties created by the 21st Century Cures Act. If OIG determines that an individual or entity has committed information blocking, they may be subject up to a $1 million penalty per violation.
    • “The final rule does not impose new information blocking requirements. OIG incorporated regulations published by the Office of the National Coordinator for Health Information Technology (ONC) as the basis for enforcing information blocking penalties. For more information on ONC’s information blocking regulations see: Information Blocking.
    • “To report complaints about information blocking, please visit the ONC Information Blocking Portal or the OIG Hotline.”
  • HR Dive points out the steps that covered employers to take to comply with the Pregnant Workers Fairness Act, which took effect today.

From the public health front —

  • The Washington Post reports,
    • “For the first time in two decades, malaria infections have been confirmed in people who did not travel outside the United States, leading federal health authorities to warn about the potential for transmission of the mosquito-born disease within the nation’s borders.
    • “Four people in Sarasota County, Fla., and one in Cameron County, Tex., were confirmed as having been infected between late May and late June through local transmission. All have gotten treatment and are recovering as health officials watch for additional cases, the Centers for Disease Control and Prevention said.
    • “Although the potentially fatal disease was once endemic, it was declared eliminated in the United States in 1951. About 2,000 people are diagnosed with malaria in the nation each year, but those cases have involved trips abroad. For a handful who came down with the disease in recent months, that was not the case.
    • “The risk of getting malaria in the United States “remains extremely low,” the CDC said. Still, experts said Americans should be aware of the possibility and take steps to prevent mosquito bites.”
  • The CDC discusses a recent study examining the health impact of widening the age range eligible for cost-free in-network diabetes type 2 testing.
  • The Health and Human Services Department “released a report showcasing evidence-based interventions to support physical activity among adults ages 65 years and older. By the year 2030, 1 in every 5 Americans will be age 65 or over. More than 85 percent of older adults currently have at least 1 chronic health condition. The growing population of older adults can gain substantial health benefits and prevent or manage chronic disease by engaging in physical activity.”

From the Rx coverage front —

  • Health Affairs lets us know that
    • “Using Medicare claims, we documented US prescribing patterns for originator biologic trastuzumab (Herceptin), a targeted cancer therapy, and five biosimilar entrants since 2019. The first biosimilar captured a dominant share, but over time, average sales prices of all products declined, and later entrants became dominant in some states. Despite strong brand loyalty to the first biosimilar, competitive pressure increased with subsequent entrants.”
  • Beckers Hospital Review relates
    • “With about a dozen cancer drugs on back order and no clear end to the shortages, the American Society of Clinical Oncology and the Society of Gynecologic Oncology recently advised clinicians to ration chemotherapy supplies. 
    • “The updated guidelines recommend curbing or halting pharmaceutical treatment for patients with “recurrent, agent-resistant cancers” — which means saving therapies for patients with a better chance of surviving. 
    • “The national cancer care group also recommended extending the time between treatments when appropriate; lessening waste by “optimizing vial size, dose rounding and using multi-use vials”; and providing support services to patients and clinicians experiencing “shortage-related distress.”
    • “Two cancer drugs in shortage that treat multiple cancers and cost about $20 per vial, cisplatin and carboplatin, have been in shortage for months. One of the main suppliers for the drugs ended operations in late 2022 after FDA investigators found numerous quality infractions and ruined reporting documents. In another inspection, the agency found more quality issues, which could further delay expected recovery. 
    • “The FDA allowed a China-based drug company to produce and import cisplatin, and the agency is working to boost carboplatin supplies.”

From the studies front —

  • The National Institutes of Health announced
    • “In people with Alzheimer’s disease, the underlying changes in the brain associated with dementia typically begin many years—or even decades—before a diagnosis. While pinpointing the exact causes of Alzheimer’s remains a major research challenge, they likely involve a combination of genetic, environmental, and lifestyle factors. Now an NIH-funded study elucidates the role of another likely culprit that you may not have considered: the human gut microbiome, the trillions of diverse bacteria and other microbes that live primarily in our intestines.
    • “Earlier studies had showed that the gut microbiomes of people with symptomatic Alzheimer’s disease differ from those of healthy people with normal cognition [2]. What this new work advances is that these differences arise early on in people who will develop Alzheimer’s, even before any obvious symptoms appear.
    • “The science still has a ways to go before we’ll know if specific dietary changes can alter the gut microbiome and modify its influence on the brain in the right ways. But what’s exciting about this finding is it raises the possibility that doctors one day could test a patient’s stool sample to determine if what’s present from their gut microbiome correlates with greater early risk for Alzheimer’s dementia. Such a test would help doctors detect Alzheimer’s earlier and intervene sooner to slow or ideally even halt its advance.”
  • Fierce Healthcare informs us
    • “Medicare Advantage (MA) beneficiaries given home-delivered meals in the four weeks after being discharged from a hospital were not only less likely to be readmitted within 30 days, they were also less likely to die, according to a study in JAMA Health Forum.
    • “The 2018 Chronic Care Act gave MA plans greater leverage to address the social determinants of healthcare. In addition to giving insurers an impetus for launching dietary programs, the act also covers transportation for beneficiaries and other at-home services.
    • “The study states that “nearly three-quarters of MA plans offered meals as a supplemental benefit in 2022, mostly driven by expectations of downstream cost savings based on findings from earlier observational studies of community-based nutrition programs, and desires to maintain market parity in an increasingly competitive MA space.
    • “Beginning in January 2021, Kaiser Permanente Southern California (KPSC) began offering home-delivered meals to eligible MA enrollees. The comparative cohort study in JAMA Health Forum examines data from 4,032 KPSC MA enrollees who’d been hospitalized for heart failure and 7,944 who’d been hospitalized for other reasons after they’d been discharged from Jan. 1, 2021, to Jan. 31, 2022. The data come from 15 hospitals in the KPSC network.”

In U.S. healthcare business news —

  • Healthcare Dive reports
    • “Walgreens missed Wall Street earnings expectations in its third fiscal quarter and cut its 2023 outlook, citing macro factors including a weak respiratory season and falling demand for COVID-19 tests and vaccines.
    • “The pharmacy chain did beat the Street’s revenue expectations with a topline of $35.4 billion, up 9% year over year, thanks in part to its expanding U.S. Healthcare segment, which includes value-based medical group VillageMD.”

Happy Juneteenth

David Ermer–Congress, Generative AI, Rx coverage, SCOTUS, SDOH, Telehealth, U.S. Healthcare–
Photo by Derek Lamar on Unsplash

Mercer Consulting offers us this background

  • “On June 19 this year, 96 year-old Opal Lee will once again invite others to join her on a 2.5 mile Walk for Freedom in Fort Worth, Texas. Known as the “Grandmother of Juneteenth,” Opal began campaigning decades ago for a national holiday to commemorate the anniversary of the day in 1865 when news of the Emancipation Proclamation finally reached the enslaved people in Galveston, Texas. In 2016, at age 89, Opal began a symbolic walk from Fort Worth to Washington D.C. in an effort to get 100,000 people to sign a petition to create the holiday. She was transported from city to city where she would walk 2.5 miles, representing the 2.5 years it took for freedom to reach Texas. By the time she made it to Washington, she had obtained over 1.5M signatures. In June 2021, her efforts succeeded – a bill to make Juneteenth a federal holiday was passed by Congress and signed into law by President Joe Biden.  
  • “Juneteenth has long been celebrated by Black people; Opal Lee has vivid memories of celebrating Juneteenth as a child in East Texas with music, food, and games. Since the creation of the federal holiday, more employers are recognizing its importance and embracing their role in promoting Juneteenth in the workplace. In 2021, just 9% of employers had made Juneteenth a paid company holiday. That jumped to 33% in 2022 and rose again this year, to 39%.”

Mercer Consulting adds

  • “For employers, the JAMA Open Network study [on healthcare disparities] underscores the pressing need to expand provider networks to be inclusive of diverse clinicians. By improving networks, and actively working with partners to dismantle barriers and biases within healthcare, we can begin to empower employees with choice – the ability to connect with providers who better understand their unique needs, experiences, and challenges. Diverse physician networks lead to stronger doctor-patient relationships, which ultimately lead to better health outcomes for marginalized populations.”

From Washington, DC —

  • The U.S. Supreme Court handed down five opinions last week. NPR identifies the remaining cases that it is tracking. (One of them the Indian Child Welfare Act was decided last week in favor of the Indian tribes.)
  • Last week, OMB’s Office of Information and Regulatory Affairs posted its Spring 2023 federal regulatory agenda. Here is a link to the OPM agenda. OPM is planning a second Postal Service Health Benefits Program rule and a rule that would accelerate the effective date of FEHB coverage for new federal employees.

Healthcare Dive reports

  • “The group that advises Congress on Medicare policy released a new report Thursday [June 15] with recommendations on telehealth, overpayments to Medicare Advantage plans and site-neutral payments across some outpatient care settings.
  • “The Medicare Payment Advisory Commission, or MedPAC, included telehealth in the report to satisfy a mandate from Congress after virtual care surged during the COVID-19 pandemic. Telehealth coverage under Medicare was limited before the public health emergency, and it was expanded to preserve access to care.
  • “The report found fee-for-service Medicare spending for telehealth care was $4.8 billion in 2020 and $4.1 billion in 2021, more than 30 times greater than 2019. Early findings show more telehealth use was associated with little change in quality, slightly improved access to care for some beneficiaries and slightly increased costs to Medicare.”

From the MD opinion front —

  • An emergency room doctor writing in MedPage Today gives us his take on the fentanyl crisis.
  • An oncologist writing in STAT News gives us her take on the cancer drug shortage. Her article’s title says it all: “Cancer drug shortages should have patients rioting in the streets.”

From the generative AI front, Healthcare IT News tells us, “An NYU Langone Health [large language model] LLM can predict hospital readmissions. The large language model is still in testing, but the AI tool had a median accuracy score of 77.8% compared to a physician score of 62.8%. The code base is now available to all healthcare organizations [via GitHub].

From the semaglutide drug front —

  • The Wall Street Journal reports that these drugs designed for weight loss also may bring alcohol and tobacco use from an addiction to a controllable level.
  • Politico discusses manufacturer lobbying efforts to convince Congress to cover these drugs for weight loss unconnected to diabetes.
  • Bloomberg informs us
    • “Some dosages of Eli Lilly & Co.’s Mounjaro are again in shortage, the latest in a line of recurring supply issues caused by patients using the diabetes medication as a weight-loss treatment.
    • “The latest shortage will result in “intermittent backorders” for three of six doses through July, according to an update posted by the US Food and Drug Administration on its website on Friday.
    • “Lilly spokesperson Jessica Thompson said the backorders were “due to continued dynamic patient demand” and would affect the three highest doses of Mounjaro. She also said the company is investing in expanding manufacturing capacity.”

From the miscellany front –

  • CNBC reports
    • “Bristol Myers Squibb on Friday sued the Biden administration over Medicare’s new powers to slash drug prices, the third such lawsuit to be filed against the program in a matter of days.
    • “The lawsuit filed in federal district court in New Jersey argues the Medicare negotiations violate the First and Fifth Amendments of the U.S. Constitution.
    • “Bristol Myers Squibb has asked the court to declare the program unconstitutional and prevent the Health and Human Services Department from forcing the company to enter negotiations.
    • “Bristol Myers Squibb’s arguments mirror those lodged last week by Merck, the first company to sue the federal government over the drug negotiations. The U.S. Chamber of Commerce has also sued HHS over the program with similar arguments.”
  • Fierce Healthcare relates
    • “Simple HealthKit has inked a deal with Walmart to bring at-home diagnostic tests, including diabetes, respiratory wellness and sexual wellness labs, to the largest retailer in the world.
    • “Through the retail giant’s website, customers can purchase tests bolstered by Simple HealthKit’s end-to-end healthcare infrastructure, including testing, follow-up and treatment. The digital health company’s HbA1c test identifies key markers for Type 2 diabetes. Respiratory wellness tests include influenza A, influenza B and respiratory syncytial virus. In light of a decrease in sexual health testing during the pandemic, customers can test for three of the most common STDs at home, chlamydia, gonorrhea and trichomoniasis.”
  • Health Payer Intelligence points out
    • Employer-sponsored health plan enrollment among nonelderly Americans will grow after 2025, accompanied by higher private payer premiums, a Health Affairs study found.
    • The study used Congressional Budget Office projections to estimate future coverage trends. However, the researchers noted many uncertainties embedded in these trends, including future economic, policy, and healthcare utilization changes. * * *
    • After 2025, enhanced subsidies will end and employment will increase, driving more people to employer-sponsored coverage. Approximately 157 million individuals may have employer-sponsored coverage in 2027. By 2033 this population will grow to 159 million.
    • Private-payer premiums will also trend upward from 2023 through 2033. In 2023, the private payer premium growth rate will be 6.5 percent. Premiums will grow 5.9 percent from 2024 to 2025 and 5.7 percent from 2026 to 2027. By 2033, the average premium increase will be 4.6 percent.
  • Of course, depending on the outcome of the 2024 federal election, it is possible that the ACA subsidies could be made permanent in 2025. Time will tell.

Friday Factoids

David Ermer–CDC, COVID-19, COVID-19 vaccine, Rx coverage, SCOTUS, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC —

  • MedPage Today reports
    • “On Friday, President Biden announced his intent to choose former top North Carolina health official Mandy Cohen, MD, MPH, to lead the CDC.
    • “Dr. Cohen is one of the nation’s top physicians and health leaders with experience leading large and complex organization and a proven track record protecting Americans’ health and safety,” Biden said in a statement.” * * *
    • “Cohen earned her bachelor’s degree at Cornell University in Ithaca, New York, her medical degree from the Yale School of Medicine in New Haven, Connecticut, and her master’s in public health from the Harvard Public School of Health in Boston. She completed her residency at Massachusetts General Hospital.”
  • STAT News suggests that Dr. Cohen’s political experience will benefit the CDC. Dr. Cohen’s nomination does not require Senate confirmation. Senate confirmation of CDC Directors will become a prerequisite in 2025.
  • Per Reuters,
    • “The U.S. Supreme Court on Friday preserved the Justice Department’s power to unilaterally dismiss lawsuits filed under a law that lets whistleblowers sue businesses on behalf of the government to recover taxpayer money paid to companies based on false claims in exchange for a portion of any recovery.”
    • In the FEHBlog’s opinion, this is a logical and welcome outcome as the federal government should have control over litigation brought on its behalf.
  • Per the FDA’s website,
    • “Today, the FDA posted information on its website regarding the formula for COVID-19 vaccines for the 2023-2024 fall and winter seasons. The FDA has advised manufacturers seeking to update their COVID-19 vaccines that they should develop vaccines with a monovalent XBB.1.5 composition. This recommendation incorporates advisory committee input and is based on the totality of the available evidence to select the vaccine composition that the FDA anticipates will best protect public health. The agency anticipates the timely submission of the data and filings to support FDA action on updated COVID-19 vaccines in order to make vaccines available this fall that meet our standards for safety, effectiveness and quality. 
    • “On Thursday, the FDA granted accelerated approval to glofitamab-gxbm (Columvi, Genentech, Inc.) for relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after two or more lines of systemic therapy. The prescribing information includes a Boxed Warning for serious or fatal cytokine release syndrome (CRS). Other warnings and precautions include neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity (ICANS), serious infections, and tumor flare. Glofitamab-gxbm should only be administered by a healthcare professional with appropriate medical support to manage severe reactions, including CRS. View full prescribing information for Columvi.”

From the miscellany department —

  • Healthcare Dive reports
    • A second major health insurer is warning investors about higher-than-anticipated outpatient care utilization that could hike medical costs, potentially cutting into profits. [UnitedHealthCare was the first.]
    • Humana filed an 8-K with the U.S. Securities and Exchange Commission on Friday morning saying elevated outpatient trends are expected to push its medical loss ratio, a marker of how much payers spend on patient care, toward the high end of its outlook for both the second quarter and the full year.
  • NPR tells us
    • Pfizer is facing a shortage of penicillin due to increased demand and more diagnoses of syphilis, the company said in a letter to its customers this week. 
    • The company said there is an “impending stock out situation” for select Bicillin L-A and Bicillin C-R prefilled syringes, Pfizer’s brand name of injectable penicillin. 
    • Prefilled Bicillin L-A pediatric syringes are expected to begin running low by the end of June, while all Bicillin C-R syringes could begin diminishing in the third quarter of this year. 
    • Inventory is predicted to start recovering in the second and third quarters of 2024, Pfizer said. 
    • Penicillin is an antibiotic used to treat various types of infections, including sexually transmitted diseases, such as syphilis and pneumonia.
  • Medscape points out
    • The American Medical Association (AMA) on Wednesday said it will advise doctors to pay less attention to body mass index (BMI) in determining if a patient is at a healthy weight, saying the measure does not predict disease risk equally well across racial and ethnic groups.
    • BMI, a ratio of weight to height, has long been used to define underweight, “normal” weight, overweight, obesity and morbid obesity, despite mounting evidence that it is an inaccurate predictor of health risks on an individual level.
    • At the influential physician group’s annual meeting in Chicago, members voted adopt a new policy that says BMI should be just one factor in determining whether a patient is at a healthy weight. Other measures such as body composition, belly fat, waist circumference, and genetic factors are also important, the AMA said. * * *
    • The AMA’s new policy also says BMI should not be used as a sole criterion for denying insurance reimbursement.
  • MedPage Today interviews the new AMA President-elect, Dr. Bruce Scott.

Weekend update

David Ermer–Congress, Rx coverage, SCOTUS, U.S. Healthcare–

From Washington, DC —

  • The House of Representatives and the Senate are in session this week for floor voting and Committee business.
  • The Supreme Court has over 20 opinions to issue before it can end its October 2022 term.
  • Fierce Healthcare reports,
    • The Federal Trade Commission is building out its deep dive into the pharmacy benefit management industry yet again.
    • The agency said Thursday that it has sent an order to the group purchasing organization Emisar Pharma Services, requiring it to provide information and records pertaining to its business practices. The order follows similar missives sent to two other GPOs, Zinc Health Services and Ascent Health Services, last month.
    • Emisar negotiates rebates with drugmakers on behalf of Optum Rx, a UnitedHealth Group subsidiary and one of the three largest PBMs.
    • The FTC said its order to Emisar is “substantially similar” to those issued to Zinc and Ascent.

Fortune Well offers us advice on the following topics:

McKinsey and Company explains how to improve children’s developmental trajectories.

Washington Post columnist discusses her recent experience taking Ozempic at length.

  • “I cannot claim to have done this for my health — certainly, appearance was my primary motivation — but the health impact has been impressive. My sleep apnea had been so severe that tests showed I was waking up an alarming 54 times every hour; new testing put it in the mild range, and my sleep apnea machine has been stashed in the closet. In November 2020, my LDL cholesterol — the “bad” kind, which raises your risk of heart disease and stroke — was at 146; it was down to 133 by March 2022 and, a year later, to 120. My A1c levels, measuring blood sugar, have fallen from on the cusp of prediabetes to safely in the normal range. My blood pressure is lower, and my C-reactive protein, an indicator of cardiovascular disease, has plummeted. * * *
  • “There are two things that are important for readers to know: My response to the medication has been extraordinary, and my experience with insurance coverage has also been unusually positive. Most insurers do not currently cover medications for obesity alone. But my doctor was able to point to my risk of developing diabetes, and my insurer, thankfully, did not question the need for coverage. “Ozempic, $24.99,” the Walgreens website informs me when I look back at my prescription records. “Insurance saved you: $1,046.10.”

Weekend update

David Ermer–Congress, SCOTUS, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

From Washington, DC —

  • The Wall Street Journal reports
    • “President Biden signed into law bipartisan legislation that suspends the $31.4 trillion debt ceiling, narrowly avoiding an unprecedented U.S. default that could have pushed the economy into a recession and touched off a financial crisis.
    • “The president signed the bill on Saturday afternoon, just two days before the government was set to run out of money to pay all of its bills, according to Treasury Department estimates.
    • “The legislation’s enactment caps weeks of tense negotiations between the White House and House Republicans that were spurred by GOP lawmakers’ demands to cut spending in exchange for raising the nation’s borrowing limit.
    • “The Fiscal Responsibility Act suspends the debt ceiling through Jan. 1, 2025, pushing the issue beyond the 2024 elections, in exchange for cuts in unspecified domestic programs and a 3% cap on increases for military spending in fiscal 2024.
    • “It provides $45 billion for a recently created program expanding coverage for veterans exposed to toxic burn pits, formally ends a three-year freeze on student-loan payments, expedites large-scale energy and infrastructure projects and raises to 54 the age at which able-bodied, low-income adults without dependents must work to receive food aid.”
  • The Supreme Court will continue to issue opinions from its October 2022 term. The Supreme Court now releases opinions on Thursdays, instead of Mondays.

From the miscellany front —

  • NPR Shots reports that “Vaccination and awareness could help keep mpox in check this summer.”
  • Health Payer Intelligence informs us
    • “After engaging in a free program provided by Capital Blue Cross (Capital), type 2 diabetes patients experienced a variety of health improvements along with noticeable financial benefits, according to a press release that HealthPayerIntelligence received by email.
    • “According to the Centers for Disease Control and Prevention (CDC), about 37 million people in the US have diabetes, accounting for 11 percent of the population. The CDC also noted that about 1 in 3 Americans will develop diabetes at some point during life.
    • “However, in 2021, Capital [which serves central Pennsylvania] began providing a program that aimed to lessen the effects of type 2 diabetes. Along with this, the insurer launched a program that aimed to lessen the risk of developing the disease, while helping those with the disease handle its effects.
    • “According to a Capital update released earlier this month, the program has led to various positive effects.”
  • HR Dive tells us
    • “Employees who take Family and Medical Leave Act leave in partial or intermittent increments during a week may not have holidays that fall during the same week counted against their FMLA leave, U.S. Department of Labor Principal Deputy Administrator Jessica Looman wrote in an opinion letter May 30. 
    • “On the other hand, if an employee uses a full workweek of FMLA leave during a week that includes a holiday, that holiday counts against their FMLA leave allotment, she said.
    • “This method of counting holidays is not a change from past provisions, Looman clarified, saying the department has used the same approach since the first publication of its FMLA regulations in 1995.”

Thursday Miscellany

David Ermer–Congress, End of the PHE, NE, FDA, Medical / Rx research, OPM, SCOTUS, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC, Roll Call reports

“Lawmakers from both parties suggested negotiators were making progress Thursday toward a bipartisan deal that would raise the $31.4 trillion debt limit, though days of talks still lie ahead.

“Scrambling to avert a debt limit breach that Treasury Secretary Janet L. Yellen said could hit as early as June 1, negotiators are attempting to reach a framework for a deal by Sunday, when President Joe Biden returns from a trip to the G-7 summit in Japan.

“Speaker Kevin McCarthy, who is negotiating with Biden through proxies, said he is hopeful that a deal could come as soon as this weekend. In a sign of progress, the two parties have begun to exchange offers, said House Rules Chairman Tom Cole, R-Okla.

“We’ve made good progress this week, but the work continues,” said Senate Majority Leader Charles E. Schumer. “ No one will get everything they want.”

“If a deal is reached by Monday, the House would vote next week, with 72 hours notice after the text is posted. While the Senate is scheduled to be in recess next week, Schumer said his chamber would be prepared to reconvene with 24 hours’ notice to schedule a vote.”

Per STAT News

“Pharmacy benefit managers would be subject to new transparency rules under a bill that cleared a key House subcommittee, Modern Healthcare says. The Transparent PRICE Act of 2023, which received a unanimous vote in the House Energy and Commerce Committee’s Health Subcommittee, would require pharmacy benefit managers to annually provide employers with detailed data on drug spending, including acquisition costs, out-of-pocket spending, formulary-placement rationale, and aggregate rebate information. The bill also would order the Government Accountability Office to report on group health plan pharmacy networks, including those owned by health insurers.”

Fierce Healthcare discusses other healthcare actions taken by this subcommittee yesterday.

BioPharma Dive tells us

“The U.S. Supreme Court on Thursday ruled against Amgen in its decade-long battle with Sanofi and Regeneron, affirming a lower court’s decision that Amgen’s rivals did not infringe on patents the biotechnology company held on a cholesterol-lowering medicine.

“In a unanimous decision authored by Justice Neil Gorsuch, the court said two Amgen patents on its PCSK9 inhibitor Repatha fell short of a legal standard known as enablement, which requires the claimed invention be described well enough to allow a skilled person in the field to use it. * * *

“The court’s ruling could open the door for challenges to older classes of antibody therapies, [University of Illinois law professor Jacob]Sherkow said. “This decision is probably going to give challengers solace. They’re going to have good options when working with the enablement requirements to challenge competitors’ patents out there.”

From the public health front —

  • The Robert Wood Johnson Foundation released its 2023 U.S. county health rankings while the UnitedHealthFoundation issued its 2023 Seniors Report from its America’s Health Rankings Services.
  • MedPage Today informs us
    • “The CDC encouraged populations at risk of contracting mpox, formerly known as monkeypox, to get fully vaccinated against the disease as part of preparations for summer during a briefing Thursday morning.
    • “Demetre Daskalakis, MD, the White House National Mpox Response Deputy Coordinator, noted that with summer gatherings on the horizon, mpox vaccination should be considered, as should overall sexual health and wellness.
    • “Getting ‘summer ready’ means mpox vaccination, but that’s not all it means — it also means to be up to date on all of your sexual health, and that includes HIV and STIs [sexually transmitted infections] like syphilis, gonorrhea, and chlamydia,” he said.”
  • The Department of Health and Human Services posted a fact sheet with “Resources on Ways Communities Can Stay Protected from Mpox in Advance of Summer Months.”
  • The Wall Street Journal points out the important medical tests that Americans should consider undergoing over the decades of life.
  • The U.S. Preventive Services Task Force notified the public about a draft research plan concerning “Weight Loss to Prevent Obesity-Related Morbidity and Mortality in Adults: Interventions” that is open for comment until June 14, 2023.

From the Food and Drug Administration front, the Wall Street Journal reports

“The Food and Drug Administration for the first time cleared a test to gauge a mother’s risk of severe preeclampsia, a leading cause of pregnancy-related illness and death in the U.S.  

“Thermo Fisher Scientific said Thursday that the blood test it already sells in Europe could be available in the U.S. soon. Its introduction could transform prenatal care in the U.S., doctors and maternal-health advocates said.”

Bravo.

From the U.S. healthcare business front —

  • Beckers Hospital Review notes five new details about Kaiser Permanente’s Risant Health deal.
  • Fierce Healthcare discusses provider objections to what appears to the FEHBlog to be a reasonable new prior authorization program that UnitedHealthcare is introducing. No good deed goes unpunished.

From the miscellany department —

  • STAT News relates that
    • “A multibillion-dollar science agency tasked with slashing through research bureaucracy will start its work with a plan to help people regenerate bone.
    • “The Advanced Research Projects Agency for Health, launched a little more than a year ago, announced Thursday that its first official program would target bone and joint damage from osteoarthritis, a condition affecting more than 32 million Americans.”
  • Govexec discusses FEHB coverage of Covid tests and vaccines following the end of the PHE.
  • The Equal Employment Opportunity Commission weighs in on the Title VII compliance implications of employer use of artificial intelligence to make employment decisions.

Weekend update

David Ermer–Congress, COVID-19, SCOTUS, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

The Senate is in session this week for Committee business and floor voting while the House of Representatives is on a District work break.

Roll Call notes that the Supreme Court completed its final oral arguments for the current term last week. The Court has dozens of opinions to issue over the next two months.

From the public health front —

The Wall Street Journal reports

  • “U.S. Covid-19 hospitalizations and deaths are hovering near new lows, providing fresh evidence that even as the virus endures it has become less damaging in a population with strengthened immune defenses. 
  • “New subvariants are on the rise, and cutbacks in data reporting have clouded the view of recent trends. But the U.S. has broadly recorded declining numbers this year following a winter of less intense Covid-19 spread. 
  • “This is the first week I have been in the ICU and have not had a Covid-positive patient,” said Dr. Michelle Prickett, a pulmonary and critical-care specialist at Chicago’s Northwestern Memorial Hospital. Federal data show the average number of adults with Covid-19 in intensive care beds hit new lows this month nationally, too.” 

An expert writing Medpage Today suggests risk adjusting the start of breast cancer screening:

  • “The USPSTF recommends age 50 as the start for screening, and adds that women ages 40 to 49 years make an individual decision about screening after discussing the risks and benefits with their primary care practitioners. However, many physicians are not equipped with necessary evidence-based information on how race and ethnicity may influence risk. In other words, guidelines get women to practitioners and practitioners get to the ambiguous guidelines; a vicious cycle that is harmful for Black women at high risk of breast cancer. Studies on race and ethnicity-adapted breast cancer screening provide the precise information that practitioners would need — but many aren’t aware of — for a race and ethnicity-tailored starting age of breast cancer screening.”

An expert writing in Medscape evaluates the utility of the entrenched body mass index measure and considers alternatives.

  • “BMI is trash. Full stop.” This controversial tweet, which received thousands of likes and retweets, was cited in a recent Medscape perspective by one doctor on when physicians might stop using body mass index (BMI) to diagnose obesity.
  • “Body mass index (BMI) has for years been the consensus default method for assessing whether a person is overweight or has obesity, and is still widely used as the gatekeeper metric for treatment eligibility for certain weight-loss agents and bariatric surgery.
  • “But growing appreciation of the limitations of BMI is causing many clinicians to consider alternative measures of obesity that can better assess both the amount of adiposity as well as its body location, an important determinant of the cardiometabolic consequences of fat.”

From the U.S. healthcare front, NPR Shots and Fortune Well look at the growing use of hospital at home services from the patient’s perspective.

Friday Factoids

David Ermer–CDC, Congress, COVID-19, End of the PHE, NE, Federal employment benefits, SCOTUS, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From the end of the PHE front, the CDC’s daily Covid tracker continues to point down; flu activity remains low nationally, and OPM released its end of PHE guidance for FEHB carriers yesterday.

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

  • “The Supreme Court on Friday allowed the widely used abortion pill mifepristone to remain on the market indefinitely, granting emergency requests from the Biden administration and the brand-name manufacturer of the drug.
  • “The high court blocked the effect of a lower-court order that was poised to limit access to the pill, which is used in more than half of U.S. abortions. The Supreme Court’s action wasn’t a decision on the merits of the case; instead, the justices were deciding whether the pill could remain available during a continuing legal challenge brought by antiabortion groups.
  • “The court’s order was unsigned and provided no reasoning, as is typical in emergency actions. But it indicated that FDA-approved access to mifepristone would remain until litigation concludes in the lower courts and the Supreme Court itself has an opportunity to review those decisions—a timeline that likely will take many months.”

From the U.S. healthcare business front —

  • STAT News informs us,
    • Patient volumes are back in a big way, at least for the country’s largest for-profit hospital operator.
    • HCA Healthcare beat Wall Street’s expectations of profitability in the first quarter of 2023, as more people flocked to HCA’s hospitals, surgery centers, and physician clinics. Inpatient admissions, all types of surgeries, and emergency room visits were each up significantly in the first quarter of this year, compared with the same period last year, when the Omicron variant of the coronavirus stymied a lot of patient care.
  • The American Hospital Association adds,
    • Financial reserves play an important role for not-for-profit hospitals and health systems in ensuring that they can continue to serve their communities in the face of challenging operational and financial headwinds, according to a new report prepared for the AHA by Kaufman Hall. The report explains how financial reserves enable struggling not-for-profit hospitals and health systems to make needed investments, borrow at affordable interest rates, cover operating expenses and remain available to their communities as surging labor and supply costs, investment losses and other challenges persist. 

From Capitol Hill, STAT News reports,

  • Amid a scramble to assemble a health care policy package in the Senate, a pair of key senators have significantly changed a proposal to cap insulin costs.
  • The new legislation by Senate Diabetes Caucus co-chairs Sens. Jeanne Shaheen (D-N.H.) and Susan Collins (R-Maine) would cap insured patients’ insulin costs at $35 per month for at least one insulin of each type and dosage form, and require pharmacy benefit managers to pass through rebates they collect from insulin manufacturers to the insurance plans that employ them.
  • The legislation also includes several provisions related to biosimilar policy. The bill would create a new, expedited pathway for the Food and Drug Administration to consider biosimilars that would be alternatives to biologics without adequate competition and would allow Medicare drug plans to put biosimilars on their formularies as soon as they come on the market.
  • That is a major shift from the version of the bill that the senators released last year, which was structured differently around offering incentives to get drug manufacturers to voluntarily lower the prices of insulin.

Politico discusses a bipartisan bill to shift some Medicare coverage to home.

From the miscellany front, Healthcare Dive offers a potpourri of wrap-up stories on the HIMSS conference that ended yesterday.

    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.

    Monday Roundup

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

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

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

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

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

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

    Makes sense to the FEHBlog.

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

    From the U.S. healthcare business front —

    Fierce Healthcare informs us

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

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

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

    and

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

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

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

    Fierce Healthcare points out a twist in the second story.

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

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

    This background information can fill knowledge gaps for employers too.

    From the Rx coverage front —

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

    Final Evidence Report on Fezolinetant for Vasomotor Symptoms Associated with Menopause

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

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

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

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

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

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

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

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

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

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

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

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

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