Thursday Miscellany

FDA

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.

Monday Roundup

David Ermer–AHRQ, Congress, FDA, Federal employment benefits, HSA, Rx coverage, SDOH–
Photo by Sven Read on Unsplash

From Washington DC —

  • The Wall Street Journal reports,
    • “Time isn’t on Washington’s side.
    • “With the U.S. facing a potentially economy-shaking default as soon as next month, logistical hurdles, disagreements on the scope of any talks, a tight legislative calendar and a late start are complicating negotiations over raising the debt ceiling.
    • “President Biden said Monday that the next meeting with congressional leaders will come Tuesday, while responding “no” when asked if there were updates regarding the talks with Republicans. House Speaker Kevin McCarthy (R., Calif.) said that the two sides remain “far apart” and that he would like a deal to be done by this weekend.” * * *
    • “A second meeting with the president and congressional leaders that was originally set to take place on Friday was postponed until early this week. The House and Senate are scheduled to be in session simultaneously for just one more week this month, and Mr. Biden is set to travel overseas for a Group of Seven meeting. Moreover, Republican leaders have so far rejected any short-term debt deal to buy more time.”
  • According to the White House’s briefing room,
    • “President Biden announced his intent to nominate Dr. Monica Bertagnolli as Director of the National Institutes of Health (NIH), the world’s preeminent biomedical research organization. Dr. Bertagnolli is a world-renowned surgical oncologist, cancer researcher, educator, and physician-leader who has the vision and leadership needed to deliver on NIH’s mission to seek fundamental knowledge and promote human health.”  

From the litigation front, the American Hospital Association informs us

“The U.S. Court of Appeals for the 5th Circuit today temporarily restored an Affordable Care Act requirement that most health plans cover certain preventive services without cost sharing. The 5th Circuit ordered that this requirement remain in effect for everyone (except the few health plans challenging the requirement) until it issues a final decision in the case, which is expected later this year. A federal judge in Texas recently vacated the requirement nationwide, prompting the Department of Health and Human Services and plaintiff to appeal the decision and seek this temporary stay.”

From the public health front —

  • HealthDay tells us,
    • “Older Americans are dying of falls at more than double the rate of 20 years ago — with women, men and all racial groups showing increases, according to a new study.
    • “In 2020, the study found, just over 36,500 Americans age 65 and up died of a fall-related injury. That was up from roughly 10,100 deaths in 1999.
    • “Adjusted for age, those numbers translated into a more than twofold increase in the rate of fall-related deaths among older Americans: from 29 per 100,000 in 1999, to 69 per 100,000 in 2020.” * * *
    • The National Council on Aging has a tool for older adults to check their risk of falls.

From the Rx coverage front —

  • MPR relates
    • “The Food and Drug Administration’s (FDA) Pulmonary-Allergy Drug Advisory Committee voted 16:6 in favor for adults, and 17:5 in favor for children (<18 years of age and ≥30kg), that available data support a favorable benefit-risk assessment for neffy® in the treatment of severe allergic reaction (Type 1), including anaphylaxis, for adults and children who weigh more than 30kg. * * *
    • “While not bound to the committee’s recommendations, the FDA does take them into consideration when making final decisions on approval. If approved, neffy would be the first needle-free epinephrine product to treat severe allergic reaction. A decision is expected by mid-2023.”
  • The Institute for Clinical and Economic Review (ICER) announced today that it will assess the comparative clinical effectiveness and value of sotatercept (Merck & Co) for pulmonary arterial hypertension.
  • The Wall Street Journal delves into “How to Get Your Health Insurance to Cover Ozempic and Other Drugs Used for Weight Loss; Tips for checking whether your health plan will pay for a prescription and then getting authorization.”
  • Per Hub International,
    • “CMS recently released its updated Medicare Part D guidelines that can be used by group health plan sponsors to determine whether their plans’ prescription drug coverage is creditable for 2024 and to update the information needed for required Part D disclosures to eligible individuals and to CMS.
    • “To help determine whether prescription drug coverage is creditable, CMS has released the following 2024 parameters for the standard Medicare Part D prescription drug benefit:
      • Deductible: $545 (up from $505 in 2023);
      • Initial coverage limit: $5,030 (up from $4,660);
      • Out-of-pocket threshold: $8,000 (up from $7,400);
      • Total covered Part D spending at the out-of-pocket expense threshold for beneficiaries who are not eligible for the coverage gap discount program: $11,477.39 (up from $10,516.25 in 2023); and
      • Estimated total covered Part D spending at the out-of-pocket expense threshold for beneficiaries who are eligible for the coverage gap discount program: $12,447.11 (up from $11,206.28).”

From the artificial intelligence front —

  • This week’s episode of the Econtalk podcast features an artificial intelligence discussion between host Russ Roberts and his guest Tyler Cowen. Russ Roberts suggests using ChatGPT to formulate questions for your doctor or your parents’ or your kids’ doctors.
  • Bloomberg examines the use of AI by drug manufacturers.
  • Medcity News looks into the use of AI by pharmacists and PBMs.

From the miscellany department —

  • Fierce Healthcare points out, “Million-dollar claims per million covered employees rose 15% in the past year and 45% from 2019 to 2022, according to a report by Sun Life, a life and disability insurance company.”
  • EHR Intelligence reports,
    • “The Health IT End-Users Alliance has released a consensus statement regarding collecting and using social determinants of health (SDOH) data to support health equity.
    • “The Alliance brings together health information professionals, physicians, hospitals, and other front-line healthcare providers to advance end-user perspectives in health IT policy and standards development.
    • “The statement calls for additional efforts to standardize and increase the uniform collection and reporting of SDOH. The group also calls for more training on collecting this data, better use of appropriate tools and processes to manage and share SDOH, and ongoing research to support these efforts.”
  • Employee Benefit News notes, “Thirteen FSA and HSA-eligible expenses that may surprise you.”

Thursday Miscellany

David Ermer–Congress, COVID-19, End of the PHE, NE, FDA, Medical / Rx research, Rx coverage–

From Washington DC —

Photo by Josh Mills on Unsplash
  • The Secretary of Health and Human Services issued a statement on the end of the Covid health emergency which occurred today.
    • Govexec and the Society for Human Resource Management respectively discuss the impact of this event on federal agencies and employers generally.
      • SHRM notes, “President Biden in April ended the pandemic national emergency weeks earlier than expected—but the premature ending won’t shift the deadlines spelled out in the administration’s guidance from March, including the extended deadline for special enrollment in health plans. * * * July 10 will also mark the end of some COBRA-related relief, under which employees were allowed extra time to pay their COBRA premiums or to decide whether they wanted to use the coverage.”
  • The Wall Street Journal reports
    • “A highly anticipated meeting scheduled for Friday between President Biden and congressional leaders to chart a path forward on lifting the debt ceiling was postponed until next week, officials said.
    • “The delay will give White House and congressional staff more time to make progress in their closed-door spending talks, the officials said, adding that one of the lawmakers was unable to attend the meeting Friday because of a scheduling conflict.
  • STAT News informs us
    • “The Senate health committee on Thursday passed a package of bills aimed at speeding generic drug competition and reining in drug middlemen business practices. But they failed to pass an ambitious reform to the pharmacy benefit manager sector, despite strong bipartisan support for it.
    • “Chairman Bernie Sanders (I-Vt.) is pursuing the drug pricing reforms at the behest of Senate Majority Leader Chuck Schumer (D-N.Y.), who wants to hold a floor vote on an even bigger package of health bills later this year. The markup came just a day after the same panel held a major hearing on PBM and drugmakers’ role in high insulin prices.
    • “It’s not clear when the Senate would take up that package, and while the package is bipartisan, it’s not clear whether it has enough support among House Republicans to pass in that chamber. There are a few, tamer PBM bills that the House Energy and Commerce Committee is expected to mark up on May 17, but there is no indication that Senate and House lawmakers are coordinating on PBM legislation.
    • “The committee passed 18 to 3 a bill that would ban PBMs from using so-called spread pricing. It would also require that the middlemen disclose rebates, fees, and other payments they receive and to pass them on to the insurers for whom they negotiate those concessions. * * * The committee included an amendment from Sen. Tina Smith (D-Minn.), that would let patients appeal insurer decisions to make them try cheaper drugs before getting more expensive drugs.”

From the public health front, Healio tells us that “Overweight and obese BMI during adulthood appeared associated with increased risk for colorectal cancer and non colorectal gastrointestinal cancers, according to study results published in JAMA Network Open.” The FEHBlog does not think that the new generation of obesity-reduction drugs needs publicity, but there you go.

From the Rx coverage and more front, the FDA announced

  • “the supplemental approval of Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s disease. This is the first FDA-approved treatment option for this indication.”
    • Medpage Today adds, “Brexpiprazole’s labelopens in a new tab or window will continue to carry a boxed warning about the risk of increased mortality in elderly patients with dementia-related psychosis treated with antipsychotic drugs. The warning further stipulates that the drug is not approved for patients with dementia-related psychosis who are not experiencing agitation associated with Alzheimer’s dementia.”
  • and “finalized recommendations for assessing blood donor eligibility using a set of individual risk-based questions to reduce the risk of transfusion-transmitted HIV. These questions will be the same for every donor, regardless of sexual orientation, sex or gender. Blood establishments may now implement these recommendations by revising their donor history questionnaires and procedures.”
  • Beckers Hospital Review points out “The Biden administration has been taking action to address the prescription drug supply shortage, which has caused upheaval both for patients and providers, according to a May 10 Bloomberg report.”

From the medical research front —

  • STAT News reports
    • “Home to billions of cells that form trillions of connections, the human brain isn’t just the body’s most important organ; it’s also the hardest to study. But an international team of scientists using cutting-edge stem cell technology has devised a new way to better understand the brain’s cellular cleanup crew — and its connection to neurological disease.
    • “Researchers coaxed stem cells to grow into microglia, immune cells that roam the brain searching for signs of damage and that monitor and maintain neuronal connections. They then added microglia to brain organoids, tiny 3D structures of neurons that mimic some aspects of brain function, and transplanted these microglia-containing “mini-brains” into mice. Doing so caused microglia to look and behave much more like they would in a human brain compared to previous lab experiments conducted in a dish.
    • “The authors also found early hints that they could use these transplanted organoids to study disease, including the role that microglia might play in autism. Microglia in brain organoids derived from people with autism had larger cell bodies than cells from controls and had an overabundance of small cellular extensions associated with an active, inflammatory state researchers believe may contribute to the disorder.”
    • “The findings, published on Thursday in the journal Cell, are the result of a collaboration between scientists from San Diego to Germany to Israel. The study raises the possibility of using transplanted organoids to understand the complex crosstalk between neurons and immune cells across a range of diseases, and to perhaps one day use this system to test potential treatments.”
  • The Washington Post adds
    • “A skin patch being developed by a French pharmaceutical company to treat peanut allergy is showing promise in toddlers, according to a peer-reviewed study published Wednesday.
    • “The “peanut patch” outperformed a placebo in “desensitizing children to peanuts and increasing the peanut dose that triggered allergic symptoms,” said the study, which was funded by the company DBV Technologies and published in the New England Journal of Medicine.”

Tuesday’s Tidbits

David Ermer–ACA, COVID-19, End of the PHE, NE, FDA, Federal employment benefits, OPM, Telehealth–
Photo by Patrick Fore on Unsplash

From Washington DC, the Wall Street Journal reports

  • “President Biden and House Speaker Kevin McCarthy remained at loggerheads after a meeting Tuesday at the White House, appearing to make little progress in averting the first-ever default by the federal government as soon as next month.
  • “House Republicans have demanded deep spending cuts in exchange for raising the debt ceiling and criticized Mr. Biden for not starting talks earlier. But Mr. Biden and Democrats in Congress maintain that the federal borrowing limit should be raised without preconditions and have called the GOP stance irresponsible. Neither side has presented a path forward that could win enough support to pass both chambers of Congress.
  • ”I didn’t see any new movement,” Mr. McCarthy said after leaving the meeting. He said he thought negotiators only had about two weeks to reach an agreement. He said there were staff-level meetings planned and the key leaders would meet again on Friday.”

From the end of the public health emergency front —

  • The Department of Health and Human Services released a fact sheet on the end of the Covid public health emergency, which ends on Thursday, May 11.
  • The Washington Post tells us,
    • “The federal government will allow doctors to keep using telemedicine to prescribe certain medications for anxiety, pain and opioid addiction, extending for six months emergency flexibilities established during the coronavirus pandemic.
    • “The Drug Enforcement Administration and Substance Abuse and Mental Health Services Administration made the announcement Tuesday, two days before the telemedicine flexibilities were set to expire along with the coronavirus public health emergency.
    • “The ability to prescribe controlled medications remotely will run through Nov. 11, 2023. And that deadline will be longer still if doctors have already established a telemedicine relationship with patients. In that circumstance, physicians can keep prescribing the medications virtually through Nov. 11, 2024.”
  • Govexec informs us
    • “President Biden on Tuesday officially revoked the COVID-19 vaccine mandates for federal employees and contractors that had already been mired in lawsuits that prevented them from being enforced. 
    • “The mandates–issued in September 2021–will end on May 12, Biden said in an executive order. The move had been expected following an announcement from the White House earlier this month, and will coincide with the end of the COVID public health emergency on May 11.”
  • STAT News adds
    • “The White House isn’t quite ready to launch its new pandemic response office for a neat handoff at the end of the Covid-19 public health emergency, White House Covid-19 Response Coordinator Ashish Jha told reporters Tuesday.
    • “Jha said White House officials are in the middle of setting up an Office of Pandemic Preparedness and Response Policy that Congress mandated them to create in December, but it won’t be ready in time for a clean transfer at the end of the public health emergency on May 11.
    • “He deflected questions about whether he will stay on after the transition.

From the substance abuse disorder front, Google tells us that this is National Fentanyl Awareness Day, and Shatterproof addresses four myths about fentanyl.

From the preventive services front, the U.S. Preventive Services Task Force posted

  • “a draft recommendation statement on screening for breast cancer. The Task Force now recommends that all women get screened for breast cancer every other year starting at age 40. This is a B grade. More research is needed on whether or not women with dense breasts should have additional screening with breast ultrasound or MRI, and on the benefits and harms of screening in women older than 75. These are I statements.”
  • The public comment period ends on June 5, 2023.

From the litigation front, STAT News reports

  • “A federal jury handed a major win to Gilead Sciences on Tuesday in a closely watched battle with the U.S. government over the rights to groundbreaking HIV prevention pills.
  • “The jury decided Gilead did not infringe on patents held by the Centers for Disease Control and Prevention and, in fact, that the agency’s patents were invalid. The CDC helped fund academic research into HIV prevention that later formed the basis for the pills. The Department of Health and Human Services contended that Gilead refused to reach a licensing agreement despite several attempts to reach a deal.
  • “For its part, the company argued that it invented the pills — an older one called Truvada and a newer, upgraded version called Descovy — and that the concept of using Truvada to prevent HIV was well-known by the time the government tried to obtain its patents. Moreover, Gilead maintained that it acted in good faith during its negotiations with the government.”

From the tidbits front —

  • Federal News Network relates
    • “The Postal Service is falling short of its goal to start turning around its financial losses this year, but Postmaster General Louis DeJoy says the agency is taking “aggressive actions” to get the agency back on track to break even by the end of the decade.
    • “USPS reported a $2.5 billion net loss for the second quarter of fiscal 2023, and is expected to see a net loss for the entire fiscal year.
    • The agency saw more than an 8% decline in first-class mail volume and a 5% decline in package volume, compared to the same period last year.”
  • OPM announced
    • “U.S. Office of Personnel Management (OPM) Director Kiran Ahuja will deliver the commencement address to the 2023 graduating class of the University of Georgia’s (UGA) School of Public and International Affairs at the Ramsey Auditorium on the UGA campus.  
    • “Director Ahuja, an alumna of the University of Georgia School of Law, will speak to the Class of 2023 on the opportunities that a career in federal service offers. As federal agencies seek to fill the positions necessary to implement legislation such as the 2021 Bipartisan Infrastructure Law, OPM is leading the federal government’s recruitment efforts. Director Ahuja’s message to graduates will be simple: if you want a career with impact, the federal government is hiring.”
  • HUB International points out that
    • “The IRS recently released a Chief Counsel Memo confirming its long-standing position that all flexible spending account (“FSA”) expenses must be substantiated. This means that, no matter how small, each expense must have some kind of third-party verification. While Chief Counsel Memos are not official, binding IRS guidance, they are informative of the IRS’s views in a particular area.”
  • Last Wednesday, “the FDA published a new web page with details about over-the-counter (OTC) Hearing Aids: What You Should Know before and after buying an OTC hearing aid.”

 

  

Weekend update

David Ermer–Congress, FDA, Telehealth, U.S. Healthcare–
Photo by Thought Catalog on Unsplash

The Senate will be on a State work period this week, while the House of Representatives will hold a DC work week. This means that Committee business will occur.

The Wall Street Journal reports

“Top Democrats and Republicans are racing to try to find a politically acceptable way to raise the nation’s borrowing limit in the coming weeks, diving into talks that President Biden has avoided during months of impasse. 

“Mr. Biden will host House Speaker Kevin McCarthy (R., Calif.) and other congressional leaders at the White House on Tuesday, the first direct contact in months as officials grapple with the prospect of the first-ever U.S. default as soon as June 1. 

“While the two parties are publicly standing by their negotiating stances, officials on both sides of the aisle have started to quietly search for a way out of a potential crisis.”

From the Rx coverage front —

  • Fortune Well tells us,
    • “U.S. health regulators are weighing the first-ever request to make a birth control pill available without a prescription.
    • “Advisers to the Food and Drug Administration meet [this] week to review drugmaker Perrigo’s application to sell a decades-old pill over the counter. The two-day public meeting is one of the last steps before an FDA decision.
    • “If the FDA grants the company’s request, Opill would become the first contraceptive pill to be moved out from behind the pharmacy counter onto store shelves or online.
    • “In an initial review posted Friday, the FDA raised several concerns about studies of Opill, citing problems with the reliability of some of the company’s data and raising questions about whether women with certain other medical conditions would correctly opt out of taking it. It also noted signs that study participants had trouble understanding the labeling instructions.
    • “The agency will ask the panel to consider whether younger teenagers will be able to understand and follow the instructions.
    • “At the end of the meeting, the FDA panel will vote on whether the benefits of making the pill more widely available outweigh the potential risks. However, the panel vote is not binding, and the FDA is expected to make its final decision this summer.
  • Healthcare Dive reports,
    • “U.S. supply of Novo Nordisk’s weight loss drug Wegovy will be “reduced temporarily,” the company said Thursday, revealing the latest setback to a launch that’s been slowed by manufacturing issues over the last year and a half. 
    • “Availability of the lower three of Wegovy’s five doses, used as weekly starter shots to gradually increase patients’ tolerance to the drug, will be limited to ensure people who now get maintenance treatment can maintain “continuity of care,” the company said. Novo indicated the problem will be eased once it gets a new contract manufacturer up and running. * * *
    • “Despite the production hurdles, Wegovy sales continued to grow. Sales rose to 4.6 billion Danish kroner, or about $676 million, in the first quarter, up from 2.4 billion kroner the previous quarter and 1.4 billion over the first three months of 2022.”

From the health plan design front, Fierce Healthcare points out

“The first step to living healthier is choosing that lifestyle, and CareFirst BlueCross BlueShield has tapped Noom for Work to help many of its approximately 3.2 million members make that decision.

“The partnership, announced this week, will focus on CareFirst members who struggle with obesity as well as those with prediabetes, according to an announcement.

“In what Noom called a “mind-first approach,” the program will include a curriculum for those struggling with weight control that will focus on the “why” behind the behaviors that have led to problems, and then get to work on changing those behaviors.

“Included are daily lessons tailored to each person’s weight-loss goals, such as continuous education, food intake tracking and advice on how to connect to devices, such as scales and wearables, that offer not only immediate feedback but also encouragement.

From the U.S. healthcare business front, NPR Shots notes

“The Biden administration on Thursday cautioned Americans about the growing risks of medical credit cards and other loans for medical bills, warning in a new report that high-interest rates can deepen patients’ debts and threaten their financial security.

“In its new report, the Consumer Financial Protection Bureau estimated that people in the U.S. paid $1 billion in deferred interest on medical credit cards and other medical financing in just three years, from 2018 to 2020.

“The interest payments can inflate medical bills by almost 25%, the agency found by analyzing financial data that lenders submitted to regulators.”

From the fraud, waste, and abuse front, Fierce Healthcare reports

“Just as the long off-ramp from the COVID-19 public health emergency (PHE) ends and telepsychiatry providers breathe a sigh of relief with a temporary extension of virtual prescribing flexibilities, a report dropped showing an estimated $348 million in telehealth psychotherapy Medicare payments were noncompliant.

“This week, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released the findings of an audit (PDF) of Medicare payments from March 2020 through February 2021. During the audit period, Medicare Part B paid $1 billion for more than 13.5 million psychotherapy services, including telehealth services.

“Of the $1 billion in Medicare Part B payments, approximately $591 million was for psychotherapy services that were billed as telehealth services, and approximately $439 million was in payments for in-person psychotherapy services, according to the report.

“The federal watchdog estimates $580 million in improper payments for services that did not comply with Medicare requirements during the audit period, including $348 million for telehealth services, or about 60% of the payments, and $232 million for non-telehealth services.”

 

Friday Factoids

David Ermer–CDC, Congress, COVID-19, FDA, Mental health care, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Sincerely Media on Unsplash

From the public health front —

  • Here are links to the CDC’s Covid Daily Tracker and its Fluview. It turns out that the CDC is planning one more issue of its Covid statistics review on May 12. All signs continue to support ending the PHE on May 11.
  • ABC News reports on the latest results of the Youth Risk Behavior Survey, published Thursday by the Centers for Disease Control and Prevention.
  • The GAO issued a report on government efforts to curb antibiotic resistance. The Wall Street Journal adds
    • A bipartisan group of U.S. senators and representatives introduced legislation aimed at encouraging drugmakers to develop antibiotics and antifungal drugs to address a growing public health threat. 
    • Bills that lawmakers proposed in the House and Senate on Thursday would commit $6 billion to purchasing new drugs to treat drug-resistant bacteria and fungi that federal officials designate as critically important targets. 
    • Nearly three million people in the U.S. are infected each year with bacteria immune to many antibiotics, the Centers for Disease Control and Prevention said. Some 35,000 of them die. The manufacturers of some promising antibiotics have gone bankrupt because sales of drugs needed only in emergencies are small, public-health experts said. Many big pharmaceutical companies got out of the antibiotic business years ago. 
  • The Hill tells us,
    • A record-low number of adults reported cigarette use in 2022, while reported usage of electronic cigarettes rose among adults. 
    • Preliminary survey results from the Centers for Disease Control and Prevention (CDC) found just 11 percent of American adults — or about 1 in 9 — reported they are smokers, which is a drop from 12.5 percent reported in 2020 and 2021. 
    • The new data, which is based on responses from 27,000 adults, captured an uptick in e-cigarette use among adults, from 4.5 percent who reported use in 2021 to 6 percent in 2022.
  • Fierce Pharma informs us.
    • With its next-generation pneumococcal vaccine, Pfizer has been playing catch-up with Merck in the indication’s key age group—infants. Thursday, Pfizer got to the finish line 10 months after its rival, but with a shot that offers more protection.
    • The FDA approval of Prevnar 20 covers children ages 6 weeks to 17 years and gives Pfizer a chance to continue to control a market it has dominated for two decades.
    • Prevnar 20 is Pfizer’s follow-on to Prevnar 13, offering protection against seven additional serotypes. Merck’s next-gen shot, Vaxneuvance, is a 15-valent vaccine.
    • In the U.S., the seven additional serotypes covered by Prevnar 20 have shown to be associated with antibiotic resistance and heightened disease severity, according to Pfizer. In children five and younger, the seven serotypes account for 37% of the incidence of pneumococcal disease.
  • STAT News points out
    • “To equip both clinicians and patients with the tools to prevent these [maternal health] tragedies, a group of experts * * * have developed a new, evidence-based preventive care plan for those who are at moderate to high risk of preeclampsia, a pregnancy complication that can drive blood pressure dangerously high and is a leading cause of maternal and infant deaths. The care plan, published Friday in the American Journal of Obstetrics and Gynecology, recommends a range of interventions to lower a patient’s risk, including at-home blood pressure checks, treatments like low-dose aspirin, and continuing to take any other needed heart medication, which people are often wary to do when pregnant. The plan also includes lifestyle recommendations for patients like eating a Mediterranean diet, exercising, and getting at least 7 hours of sleep per night.”

From the U.S. healthcare business front —

  • BioPharma Dive report
    • “AbbVie withstood the first months of U.S. copycat competition to its lucrative arthritis drug Humira about as Wall Street had expected, conceding on price to maintain insurance coverage in response to Amgen launching the country’s first biosimilar rival in January.
    • “U.S. Humira sales totaled nearly $3 billion, a decline of 26% from the same period one year ago and just over analysts’ consensus forecasts. AbbVie executives told investors on a Thursday conference call that most of that impact was driven by price changes.
    • “Amgen, which recorded $51 million in U.S. revenue for its biosimilar Amjevita, is selling its Humira rival at two different prices: a 5% discount to Humira’s nearly $90,000 annual list price, and a 55% discount. The approach is meant to address the unique demands of the U.S. healthcare system, in which insurers rely on manufacturers providing rebates off of a drug’s sticker price.”
  • Becker’s Health IT provides more details about this week’s Kaiser Permanente deal with Geisinger, while Beckers ASC Review explores Optum’s physician acquisition strategy.

Thursday Miscellany

David Ermer–Congress, Employee Wellness Programs, FDA, Federal employment benefits, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Capitol Hill, Healthcare Dive tells us

  • “On Wednesday, lawmakers hammered CMS Administrator Chiquita Brooks-LaSure on a variety of healthcare issues in her first appearance before a congressional panel since being confirmed to her post.
  • “One of the hearing’s biggest themes was site neutrality, as members of the House Energy and Commerce health subcommittee queried the administrator on why the government pays hospital-owned outpatient sites more than other physician offices for the same services.
  • “Lawmakers on both sides of the aisle expressed support for enacting site-neutral payments, policies fiercely opposed by hospitals because they would lower revenue. * * *
  • “Members of the health subcommittee on both sides of the aisle suggested site-neutral payment reforms would save the government money and tamp down on provider consolidation.”

Fingers crossed.

CNBC reports

  • “Medicare will cover the new Alzheimer’s treatment Leqembi for all patients eligible under the medication’s label if the Food and Drug Administration fully approves the drug in July, a federal official told members of Congress on Wednesday.
  • “The official, Chiquita Brooks-LaSure, testified before Congress Wednesday for the first time since her confirmation as administrator of the Centers for Medicare and Medicaid Services.”

In other Rx coverage news, STAT News informs us.

  • “The drug giant Eli Lilly said Thursday that its diabetes drug Mounjaro helped patients with the condition lose 15.7% of their body weight in a clinical trial, a result that Wall Street analysts expect to pave the way for the therapy’s approval as a weight loss treatment.
  • “Mounjaro is the latest drug in a class known as GLP-1s or incretins — the same class as Novo Nordisk’s Ozempic, which has become a sensation because of its ability to help patients lose weight. Mounjaro has shown the potential to lead to even greater weight loss than Ozempic, and industry experts expect that it will eventually generate many billions of dollars in annual sales. Analysts at SVB Securities projected in December that Mounjaro sales could reach $26.4 billion by 2030.
  • “Eli Lilly on Thursday also announced quarterly earnings of $1.64 per share, adjusted for one-time items, slightly below analyst expectations, on sales of $6.96 billion. Sales were hurt because of a comparison to a year ago when the company’s Covid-19 monoclonal antibodies were still on the market. Mounjaro sales for the first quarter were $586 million, largely for people with diabetes, compared to an analyst consensus of $433.2 million.”

According to the American Hospital Association,

  • “The Food and Drug Administration yesterday approved the first fecal microbiota product taken orally to prevent recurrent C. difficile infection.
  • “Today’s approval provides patients and healthcare providers a new way to help prevent recurrent C. difficile infection,” said Peter Marks, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “The availability of a fecal microbiota product that can be taken orally is a significant step forward in advancing patient care and accessibility for individuals who have experienced this disease that can be potentially life-threatening.”

The Mayo Clinic adds

  • Clostridioides difficile (klos-TRID-e-oi-deez dif-uh-SEEL) is a bacterium that causes an infection of the large intestine (colon). Symptoms can range from diarrhea to life-threatening damage to the colon. The bacterium is often referred to as C. difficile or C. diff.
  • Illness from C. difficile typically occurs after use of antibiotic medications. It most commonly affects older adults in hospitals or in long-term care facilities. In the United States, about 200,000 people are infected annually with C. difficile in a hospital or care setting. These numbers are lower than in previous years because of improved prevention measures.
  • People not in care settings or hospitals also can develop C. difficile infection. Some strains of the bacterium in the general population may cause serious infections or are more likely to affect younger people. In the United States, about 170,000 infections occur annually outside of health care settings, and these numbers are increasing.

Beckers Hospital Review points out,

  • “Mark Cuban Cost Plus Drug Co. decreased 35 drug prices April 26, according to a news release shared with Becker’s. 
  • “The company began selling a few dozen generics in January 2022, and since then, Cost Plus Drugs has added about 1,000 more drugs, including four brand-name drugs, partnered with three pharmacy benefit managers and teamed up with independent pharmacists to complement its mail-order pharmacy business.  

From the public health front, Mercer Consulting explains that

“Ending the HIV epidemic in the United States is finally within our reach, but it will require all sectors of society, including employers, working together to ensure that the most powerful HIV prevention and treatment tools in history reach those who need them the most. – Health Action Alliance

“Mercer has joined a coalition of companies to help achieve what was once thought impossible – the end of the HIV epidemic in the US by 2030. Scientific advancements over the past four decades have made it possible to dramatically reduce new cases of HIV, which currently number nearly 35,000 per year in the United States. A key obstacle is misinformation, discrimination, and stigma around HIV. When we support people affected by HIV, we make it easier for everyone to lead healthy lives.

“Current HIV prevention and treatment tools mean it’s easier than ever for people to stay healthy and prevent the spread of the virus:

  • “Rapid, non-intrusive HIV tests can be done without needles, and results are available within 20 minutes or less.
  • “The use of PrEP (pre-exposure prophylaxis) can prevent people without HIV from contracting the disease. It’s available as a daily pill or a shot taken every eight weeks.
  • “A range of new antiretroviral treatments (ARTs) make it possible for people with HIV to live long, healthy lives. In addition to maintaining health, people who take their ARTs as prescribed and who achieve and then maintain an undetectable viral load have effectively no risk of sexually transmitting the virus to an HIV-negative partner.”

Mercer’s article also identifies five ways to address HIV in the workplace.

From the U.S. healthcare business front —

  • Healthcare Dive reports
    • “Teladoc beat Wall Street expectations in the first quarter and raised its 2023 guidance as a result, with management citing growing demand for chronic care offerings among employers and health plans.
    • “Teladoc’s revenue grew 11% year over year to $629 million in the first quarter, the company reported aftermarket Wednesday. Despite inflationary headwinds, direct-to-consumer mental health business BetterHelp’s revenue grew 21% year over year to $279 million. BetterHelp had almost half a million users in the quarter.”
  • MedTech Dive notes
    • “Quest Diagnostics on Thursday said it agreed to pay up to $450 million to acquire Haystack Oncology, an early-stage company focused on liquid biopsy testing to detect residual or recurring cancer.
    • “The announcement came as Secaucus, N.J.-based Quest reported a 10.7% drop in first-quarter revenue to $2.33 billion, compared to a year ago, on a faster-than-expected decline in COVID-19 testing as the public health emergency approaches an end.
    • “Revenue in Quest’s base business, excluding COVID testing, rose 10% to $2.21 billion, bolstered by strong volume growth across customer types, CEO James Davis said on the company’s earnings call.

Finally, Tammy Flanagan writing in Govexec discusses what is the best age for a federal employee to retire.

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.

Monday Roundup

David Ermer–ACA, CDC, CMS, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

The HIMSS conference is being held this week in Chicago. The HIMSS organization is providing the publich with morning and afternoon session updates.

From the regulatory front, the Department of Health and Human Services released the final 2024 Notice of Benefit and Payment Parameters which is applicable to qualified health plans in the marketplaces.

From the US healthcare business front

  • Healthcare Dive reports
    • Hospital and health system merger and acquisition activity remained consistent in the first quarter of 2023 with 15 healthcare industry transactions, a slight drop from 17 in the fourth quarter of 2022, according to a new report from hospital consultancy Kaufman Hall. The 15 transactions comprised $12.4 billion in total transacted revenue, down from the high of $12.7 billion in 2018.
    • Mergers and acquisitions are trending toward cross-regional partnerships, and the size of the smaller party in mergers is increasing to between $250 million and $750 million in annual revenue, according to the report.
    • Realignment of for-profit health system portfolios continued in the first quarter of 2023, particularly for high financial and operational performing health systems.
  • AHIP issued a report finding that hospital markups on specialty drugs cost patients thousands of dollars.
  • Beckers Hospital CFO Reports identifies 22 US hospitals that are cutting care.
  • Beckers Payer Issues informs us that
    • UnitedHealthcare’s plans to implement a gold-card program in 2024 might cut another 10 percent of its prior authorization volumes on top of a 20 percent reduction that will roll out this summer, UnitedHealthcare CEO Brian Thompson said during UnitedHealth Group’s April 14 earnings call, which was transcribed by Seeking Alpha.
    • The payer plans to implement the national gold-card program in early 2024 for care provider groups that meet eligibility requirements, according to a March 29 company news release. The gold-card status applies for most UnitedHealthcare members across commercial, Medicare Advantage and Medicaid. 
    • Qualifying care provider groups “will follow a simple notification process for most procedure codes rather than the prior authorization process,” according to the release. 

From the public health front, Medpage Today reports

  • Chronic pain continued to affect more than one in five U.S. adults, new CDC survey data showed.
  • During 2021, an estimated 51.6 million adults (20.9%) had chronic pain lasting 3 months or longer, and 17.1 million (6.9%) had high-impact chronic pain — pain severe enough to restrict daily activities — reported S. Michaela Rikard, PhD, of the CDC’s National Center for Injury Prevention and Control, and co-authors.
  • Pain prevalence was higher in adults who were American Indian or Alaska Native, who identified as bisexual, or who were divorced or separated, the researchers said in Morbidity and Mortality Weekly Report.

From the Rx coverage front, the Institute for Clincical and Economic Research released a Final Evidence Report on Lecanemab for Alzheimer’s Disease.

  • — Independent appraisal committee voted that currently available evidence is not adequate to demonstrate a net health benefit for lecanemab when compared to supportive care —
  • — Using best estimates from current data, ICER analyses suggest lecanemab would achieve common thresholds for cost-effectiveness if priced between $8,900 – $21,500 per year —
  • — Manufacturers should release all patient-level data to help patients, clinicians, researchers, and regulators understand more about the link between amyloid reduction and cognitive outcomes

Lecanemab is an FDA approved drug that the CDC is considering for Medicare coverage beyond clinical testing. The VA has agreed to cover FDA marketing label uses for the drug in its patient population which overlaps with FEHBP.

From the medical research front, a National Institutes of Health study outlines “opportunities to achieve President Biden’s Cancer Moonshot goal of reducing cancer death rates in the United States. Accelerated progress is needed to achieve Cancer Moonshot goal of cutting the age-adjusted cancer death rate by at least 50% over 25 years, NIH study says.”

  • The study was conducted by researchers in NCI’s Division of Cancer Epidemiology and Genetics, the Center for Cancer Research, and their collaborators, using data from NCI’s Surveillance, Epidemiology, and End Results (SEER) Program and the Centers for Disease Control and Prevention’s National Center for Health Statistics. The researchers examined trends in age-standardized cancer incidence, survival, and mortality rates from 2000 to 2019 for all cancers combined, as well as for the six cancers that together account for 57% of cancer deaths: lung, colorectal, pancreatic, breast, prostate, and liver. They then projected the overall cancer death rate in 2047 based on the assumption that current trends would continue.
  • According to their analysis, because of decreasing cancer incidence and improvements in survival, age-adjusted death rates from all cancers combined declined by 1.4% per year from 2000 to 2015 and by 2.3% per year from 2016 to 2019. These declines reflect substantial reductions in deaths from lung cancer (-4.7% per year during 2014–2019), as well as colorectal cancer (-2.0% per year during 2010–2019) and breast cancer (-1.2% per year during 2013–2019).
  • Trends in prostate, pancreatic, and liver cancer death rates have been less promising. Death rates from prostate cancer had declined strongly (-3.4% per year during 2000–2013), but the decline has slowed (to -0.6% per year during 2013–2019). Death rates from pancreatic cancer have been increasing (0.2% per year during 2006–2019). Death rates from liver cancer, which had been increasing for decades, recently began to decline (-0.5% per year during 2016–2019). Death rates from all other cancer types combined have declined (-1.7% per year during 2016–2019).

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.