Tuesday Tidbits

Congress

Tuesday Tidbits

David Ermer–AHRQ, Congress, Medical / Rx research, Patient safety, SDOH–
Photo by Patrick Fore on Unsplash

From Washington, DC,

Roll Call tells us,

“President Joe Biden and Speaker Kevin McCarthy on Tuesday tapped proxies to negotiate directly over how to increase the debt limit with time running short before the government runs too low on funds.”

and

“Lawmakers are beginning to think about changing their plans and staying in Washington in the coming weeks as a standoff over increasing the debt limit bears down. Members of both parties’ leadership said on Tuesday that plans for the Senate to recess next week and the House to leave town the following week could shift.”

BenefitsLink pointed out that the Internal Revenue Service released a revenue procedure identifying inflation-adjusted high deductible health plan and health savings account amounts for use in 2024 just in time for FEHB high deductible health plan benefit proposals due May 31.

STAT News reports

“In an unexpected move, the Federal Trade Commission on Tuesday filed a lawsuit to block Amgen from acquiring Horizon Therapeutics, claiming the $27.8 billion deal would make it possible for Amgen to develop monopolies through a tactic that manipulates health coverage and drives up consumer costs.

“At issue is a practice known as bundling. Simply put, a drug company combines two or more medicines in a package deal for health plans and pharmacy benefit managers, which determine lists of medicines that are covered by insurance. The practice has previously sparked concerns that a drug company will unfairly offer higher rebates for bundles in order to win favorable placement.”

From the medical and drug research fronts —

  • The National Institute of Health informs us,
    • “A study from the National Institutes of Health shows that new cases of chronic pain occur more often among U.S. adults than new cases of several other common conditions, including diabetes, depression, and high blood pressure. Among people who have chronic pain, almost two-thirds still suffer from it a year later. These findings come from a new analysis of National Health Interview Survey (NHIS) data by investigators from the National Center for Complementary and Integrative Health (NCCIH) at the NIH, Seattle Children’s Research Institute, and University of Washington, Seattle, and are published in JAMA Network Open.”
  • The New York Times reports
    • “The man should have gotten Alzheimer’s disease in his early 40s — he had a gene mutation that guaranteed it, or so it seemed. Scans of his brain even revealed severe atrophying and the hallmarks of the disease: rough, hard, amyloid plaques and spaghetti-like tangles of tau proteins. But the fatal brain disease did not appear until the man was 67.
    • “Now an intense research effort has discovered why. The man was protected because another mutation in a different gene blocked the disease from entering his entorhinal cortex. That tiny area of the brain is a hub for neurons involved in memory, recognition of objects, navigation and time perception. And it is there that scientists believe that Alzheimer’s disease begins.
    • “A paper on the finding was published Monday in the journal Nature Medicine.
    • “More than six million people in the United States have Alzheimer’s, a disease that has been notoriously difficult to treat. Yet here was a man with a mutation that causes the most severe and rapidly progressing form of Alzheimer’s. And his disease was delayed for two decades. If a drug could do what the mutation did, resulting in most people getting Alzheimer’s very late in life, the outcome could be transformative.”

From the SDOH front,

  • the National Institutes of Health shared
    • “New research shows that the economic burden of health disparities in the United States remains unacceptably high. The study, funded by the National Institute on Minority Health and Health Disparities (NIMHD), part of the National Institutes of Health,  revealed that in 2018, racial and ethnic health disparities cost the U.S. economy $451 billion, a 41% increase from the previous estimate of $320 billion in 2014. The study also finds that the total burden of education-related health disparities for persons with less than a college degree in 2018 reached $978 billion, about two times greater than the annual growth rate of the U.S. economy in 2018.”

From the AI department,

  • Beckers Payer Issues informs us
    • Payers are putting artificial intelligence to work. 
    • Google recently launched a new AI-powered cloud program for prior authorization and claims processing. Elevance Health is piloting AI-powered concierge care for members. 
    • Becker’s asked 18 payer executives how AI will transform the insurance industry. [The interview squibs are available in the article.]

From the patient front, here is a link to HHS’s Agency for Healthcare Quality and Research March 2023 Chartbook on Patient Safety.

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.”

Weekend update

David Ermer–Congress, OPM, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

Happy Mothers’ Day! Here’s a reminder that on June 27, 2023, two new federal employment laws will take effect — the Pregnant Workers Fairness Act and the PUMP Act (fairness for nursing mothers).  

OPM shares excerpts from OPM Director Kiran Ahuja’s commencement address to the graduating class of the University of Georgia’s School of Public and International Affairs.

The House of Representatives and the Senate will be in session this week for Committee business and floor voting.

The Wall Street Journal reports

  • The Biden administration and congressional Republicans are making progress in their negotiations over federal spending and raising the debt limit, Treasury Secretary Janet Yellen said, adding that she believes the talks could result in an agreement.
  • “I’m hopeful. I think the negotiations are very active. I’m told they have found some areas of agreement,” Ms. Yellen said in an interview Saturday at the end of a gathering of finance ministers from the Group of Seven advanced democracies in Japan.
  • Republicans and Democrats are racing to find a compromise for raising the nation’s roughly $31.4 trillion debt limit. Republicans say lifting the debt ceiling should be paired with cuts to federal spending, while Democrats say raising the cap shouldn’t be contingent on broader budget negotiations.

Axios tells us that “The Biden administration is pouring billions of dollars into the development of future coronavirus vaccines, trying to develop a sequel to Operation Warp Speed even as the public health emergency ends.”

Also, from the research front, Biopharma Dive informs us

  • Sanofi and AstraZeneca released new study results on Friday [May 11] that showed their antibody drug for respiratory syncytial virus reduced hospitalizations for infection-related respiratory disease by 83% in infants.
  • The drug, sold as Beyfortus, won approval in Europe in November as a preventive treatment for babies in their first RSV season and is due a decision by U.S. regulators in the third quarter. The results released Friday add to earlier data that showed the drug to be 75% effective in reducing RSV-related hospitalizations over a placebo.
  • RSV is a leading cause of hospitalization in infants, often overlapping with seasonal patterns for influenza and now COVID-19, too. It is estimated that more than 25,000 children under 5 years old die from RSV infections globally each year, with millions hospitalized.

and MedTech Dive points out,

  • Guardant Health on Tuesday presented the results of a pivotal study of Shield, its blood-based test for colorectal cancer, demonstrating an overall sensitivity of 83% and specificity of 90%.
  • Looking at the results by stage, the test only detected 55% of stage I cancers. Its detection of later-stage cancers was 100%.
  • The test should meet the criteria to gain FDA approval and Medicare reimbursement, but its early-stage performance will likely make Shield less competitive against Exact Sciences’ stool-based test, Cologuard, to start, analysts with Craig Hallum wrote in a research note on Wednesday. 

From the SDOH front, Healthcare Finance relates,

  • CVS Health said this week it’s adding mental health screenings to Project Health, the company’s free, community-based health screening program. 
  • It will kick-start its mental health screenings in Greensboro, North Carolina and Petersburg, Virginia. Over the course of the year it will also add nearly 100 organizations to host its mobile units in under-resourced communities.
  • CVS Health plans to host nearly 2,000 Project Health screening events across the U.S. in 2023. The company hosts these events at CVS Pharmacy locations and community organizations, offering free biometric screenings, including blood pressure, cholesterol, glucose level and body mass index, to detect early risks of chronic conditions such as diabetes, hypertension and heart disease.
  • The screenings will now also offer PHQ-2 assessments – screenings to help identify people who require additional evaluation for depression. Following these screenings, participants have the opportunity to meet with a nurse practitioner who can provide referrals for treatment and advice on follow-up care.

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.”

Midweek Update

David Ermer–Congress, End of the PHE, NE, NCQA, NIH, OPM, Rx coverage, Telehealth, Uncategorized–
Photo by Michele Orallo on Unsplash

From Capitol Hill —

Roll Call reports

  • “The White House and congressional leaders are discussing the duration of appropriations caps and a debt limit raise as staff talks get underway in advance of the next principals meeting on Friday.
  • “A two-year appropriations deal is under consideration, according to sources familiar with the talks, along the lines of three separate laws since 2015 that were paired with suspensions of the debt limit. 
  • “The White House and top Democrats are pushing for two years of debt limit breathing room, as in the 2019 deal cut with former President Donald Trump. That law contained two years of spending caps, which Speaker Kevin McCarthy pointed out as far back as January.
  • “Such an arrangement would, in theory, remove the threat of fiscal cliffs facing lawmakers and the economy until after the 2024 elections.”

Fierce Healthcare tells us,

  • “The Senate Health, Education, Labor and Pensions (HELP) Committee convened the heads of three big pharmas—Eli Lilly CEO David Ricks, Novo Nordisk CEO Lars Fruergaard Jørgensen and Sanofi CEO Paul Hudson—as well as the top brass at the three largest PBMs—CVS Health Executive Vice President and President of Pharmacy Services David Joyner, Express Scripts President Adam Kautzner and OptumRx CEO Heather Cianfrocco.
  • “The legislation on the docket for the HELP Committee aims to inject transparency into the pharmaceutical supply chain as well as increase access to generics. PBM reforms on the table include eliminating spread pricing models as well as clawbacks from pharmacies. * * *
  • “The HELP Committee will convene Thursday to mark up four bills that target drug pricing. Sanders said that while these measures are a priority, there’s more work to be done in addressing this issue. He added that issues with affording drugs are a broader part of the ongoing challenges around affordability in healthcare.”

Tomorrow is the last day of the Covid public health emergency, and today the Department of Health and Human Services posted a fact sheet on how the end of the PHE affects telehealth.

From the Rx coverage front, the Wall Street Journal points out

  • “Advisers to the Food and Drug Administration recommended making an oral contraceptive available without a prescription for the first time, potentially widening access to birth control for women across the country. 
  • “The panel of FDA advisers voted 17 to 0 on Wednesday that there was enough evidence for the agency to approve the medication’s sale over-the-counter. The FDA, which is expected to make a final decision this summer, doesn’t have to follow the expert panel’s advice, though it often does.
  • “The FDA approved the pill, called Opill, for prescription use in 1973. HRA Pharma, owned by Perrigo, a Dublin-based generic drugmaker, submitted its application to make Opill available over-the-counter last July. 
  • “The advisory panel said the benefits of making oral contraceptives available over-the-counter outweighed the risks.”

The cost curve is pointing down.

From the medical research front, the National Institutes of Health updates us on multiple mRNA vaccines that show promise for treating HPV-Related cancers.

From the healthcare quality front, NCQA informs us

  • “We launched our Race and Ethnicity Stratification Learning Network.
  • “The network is a free, interactive, online tool that offers data and best practices to help health plans improve how they collect race and ethnicity data on enrollees.
  • Improving data collection of race and ethnicity data is vital to improving health equity.
  • “The data available in this new resource summarize the care of 20 million people enrolled in 14 health plans that reported results on 5 HEDIS measures, stratified by race and ethnicity.
  • “Best practices we identify come from NCQA’s qualitative interviews of key staff at plans in the learning network.
  • “A report groups our findings in three areas.”

Check it out.

From the federal employment front, the Office of Personnel Management announced

  • released proposed regulations that would prohibit the use of previous salary history in setting pay for federal employment offers. Under the new proposed regulations, federal agencies would not be able to consider an applicant’s salary history when setting pay for new federal employees in the General Schedule pay system, Prevailing Rate pay system, Administrative Appeals Judge pay system, and Administrative Law Judge pay system.  
  • “These proposed regulations are a major step forward that will help make the federal government a national leader in pay equity,” said OPM Director Kiran Ahuja. “Relying on a candidate’s previous salary history can exacerbate preexisting inequality and disproportionally impact women and workers of color. With these proposed regulations, the Biden-Harris Administration is setting the standard and demonstrating to the nation that we mean business when it comes to equality, fairness, and attracting the best talent.” 

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.”

 

Midweek Update

David Ermer–Congress, Medical / Rx research, Patient safety, Rx coverage, U.S. Healthcare–

From Washington, DC, the Wall Street Journal reports

  • “The Biden administration and Capitol Hill leaders are scrambling to avoid a first-ever government default that could arrive as soon as June 1, taking potential alternative strategies more seriously after months of deadlock over raising the country’s borrowing limit.  
  • “Publicly, both Republicans and Democrats are still sticking to their demands as the clock ticks. GOP lawmakers are seeking to force cuts to federal spending in exchange for supporting raising the debt limit, while Democrats continue to call for a debt-limit increase without any other policy conditions.
  • “Privately, though, Biden administration officials and lawmakers have started to weigh potential alternatives to their negotiating position, including a short-term increase in the borrowing limit that would buy them time to find a compromise, according to people familiar with the matter. Biden administration officials are also taking a fresh look at experimental ways the U.S. could potentially keep paying the government’s bills even if Congress doesn’t raise the debt limit, the people said.” 

From the Rx coverage front —

MedPage Today informs us,

  • “The FDA has approved the first-ever vaccine for respiratory syncytial virus (RSV), the agency announced on Wednesday.
  • “Marketed under the trade name of Arexvy, the adjuvanted RSV prefusion F protein-based vaccine is specifically indicated for preventing lower respiratory tract infections in adults 60 and over.
  • “Until now, no vaccine has existed to protect against RSV infection, a common scourge both for young children and older adults.  * * *
  • “GSK said the vaccine would be available ahead of the 2023/2024 RSV season, and that the CDC’s Advisory Committee on Immunization Practices will weigh in on the RSV vaccine’s appropriate use in June.”

Beckers Pay Issues points out,

  • “Payers are anticipating the cost of expensive new gene therapy drugs to be a significant issue in the coming years, according to a survey from the Pharmaceutical Strategy Group. 
  • “The survey, published May 1, asked 182 benefits leaders at employers and health plans about their organization’s specialty drug benefit design. 
  • “Read the full report here. “

From the drug research front, the Wall Street Journal reports

  • “An experimental Eli Lilly drug slowed cognitive and functional decline for people with early-stage Alzheimer’s disease in a new study that signals drugmakers are turning a corner in long-running efforts to find meaningful treatments for the memory-robbing disease.
  • “Based on the new data, Lilly said Wednesday it plans to apply this quarter to the U.S. Food and Drug Administration for approval to market the drug, setting up a potential agency decision later in 2023 or in 2024. * * *
  • “Researchers designed Lilly’s drug donanemab and Leqembi, from Eisai and Biogen, to work by targeting and reducing amyloid, a substance that forms plaque in the brain and is a prime suspect in fueling the worsening of Alzheimer’s. * * *
  • “In the study of more than 1,730 patients, the [intravenously administered] drug slowed patients’ decline by 35% compared with people who received a placebo over 18 months of treatment, Lilly said. Researchers gave the drug to elderly people who testing indicated were in the early stages of Alzheimer’s. * * *
  • “The findings could bolster donanemab’s appeal to some doctors and patients when compared with Eisai and Biogen’s Leqembi, according to analysts.
  • “Leqembi slowed Alzheimer’s patients’ decline by 27% versus a placebo over 18 months in a separate study, though there were differences in the studies that make direct comparisons difficult.
  • “Yet Leqembi’s safety profile might give it an advantage over donanemab with other doctors and patients, analysts said.”

From the U.S. healthcare business front, Healthcare Dive informs us that “CVS [Health] lowers 2023 earnings outlook on Oak Street, Signify deal costs.”

  • “Despite lowering 2023 earnings guidance by 20 cents to a range of $8.50 to $8.70 per share, “we remain committed to achieving the $9 and $10 targets for 2024 and 2025,” CFO Shawn Guertin said on a Wednesday earnings call.”

From the patient safety front, the Leapfrog Group released

  • “the spring 2023 Leapfrog Hospital Safety Grade. An analysis found the average risk of three healthcare-associated infections (HAIs)— including Methicillin-resistant Staphylococcus aureus (MRSA), central line-associated bloodstream infections (CLABSI) and catheter-associated urinary tract infections (CAUTI)—spiked to a 5-year high in hospitals during the COVID-19 pandemic.” 
  • “Additional highlights from the spring 2023 Safety Grades include:
  • “Twenty-nine percent of hospitals received an “A,” 26% received a “B,” 39% received a “C,” 6% received a “D,” and less than 1% received an “F.”
  • “The top ten states with the highest percentages of “A” hospitals are: New Jersey, Idaho, Utah, Pennsylvania, Connecticut, North Carolina, South Carolina, Colorado, Virginia and Massachusetts.
  • “There were no “A” hospitals in Delaware, the District of Columbia or North Dakota.

Tuesday’s Tidbits

David Ermer–Congress, Mental health care, NIH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill —

Roll Call tells us, “Senators are so far standing firm on letting Speaker Kevin McCarthy and President Joe Biden work out how to address the debt limit.” The President’s meeting with Congressional leaders will be held on May 9.

Fierce Healthcare informs us,

  • “A key Senate panel has postponed a markup hearing on several bills aimed at drug pricing until after the heads of three major drug companies and three pharmacy benefit managers appear before legislators.
  • “The Senate Health, Education, Labor and Pensions Committee convened Tuesday morning to discuss four pieces of legislation aimed at tackling the rising costs of drugs in the U.S., including a bill that would push significant reforms to the PBM industry.
  • “Instead, the committee will markup the bills on May 11, one day after hosting a blockbuster hearing on insulin and other drug pricing issues. The hearing will include testimony from Eli Lilly CEO David Ricks, Novo Nordisk CEO Lars Fruergaard Jorgensen, Sanofi CEO Paul Hudson, CVS Health President of Pharmacy Services David Joyner, Express Scripts President Adam Kautzner and OptumRx CEO Heather Cianfrocco.”

From the public health front —

  • The National Institutes of Health announced
    • Women aged 55 years and younger have nearly double the risk of rehospitalization in the year immediately after a heart attack compared to men of similar age, according to a study supported by the National Institutes of Health. Higher rates of risk factors such as obesity, heart failure, and depression among women most likely contributed to the disparity.
    • “The findings suggest a need for closer health monitoring of the approximately 40,000 American women aged 18 to 55 years who have heart attacks each year following hospital discharge, and a better understanding of the reasons behind the different outcomes. The study, funded by the National Heart, Lung, and Blood Institute (NHLBI), part of NIH, was published today in the Journal of the American College of Cardiology.”
  • The U.S. Preventive Services Task Force updated its recommendation for screeening asymptomatic adults at increased risk of latent tuberculosis infection (LTBI) with the same grade B that it last gave in 2017. The FEHBlog is impressed by the USPSTF’s routine re-evaluation of its decisions.
  • The Department of Health and Human Services announced
    • “awarding the 15 winners for Phase 1 of the HHS Endocrine-Disrupting Chemicals (EDC) Innovator Award Competition. This competition was developed to identify gaps in knowledge and innovative solutions to improving women’s health by reducing EDC exposure risk.  
    • “For far too long, Black women have been overexposed to harmful endocrine-disrupting chemicals in personal care products. We created this competition to help find innovative solutions to meet this challenge, and I want to congratulate all the winners for their incredible ideas,” said HHS Secretary Xavier Becerra. “We will continue to prioritize the health of Black women by addressing the exposure risks caused by this environmental justice issue.”
  • Kaiser Family Foundation discusses community paramedic programs.
    • Most community paramedicine programs rely on paramedics, but some also use emergency medicine technicians, nurses, social workers, and other professionals, according to the 2017 survey. Programs can offer home visits, phone check-ins, or transportation to nonemergency destinations, such as urgent care clinics and mental health centers.
    • Many programs support people with chronic illnesses, patients recovering from surgeries or hospital stays, or frequent users of 911 and the ER. Other programs focus on public health, behavioral health, hospice care, or post-overdose response.
    • Community paramedics can provide in-home vaccinations, wound care, ultrasounds, and blood tests.

From the mental health care front

  • CVS Health calls our attention to
    • “A recent CVS Health® (NYSE: CVS)/Harris Poll survey found that young adults and physicians continue to see the country struggling with mental health, but most Americans aren’t seeking care.
      • “Six in 10 (60%) respondents aged 18-32 say they are concerned about their mental health, and two thirds (67%) say they know a lot of people in their community that are struggling with mental health issues.
      • “Most physicians (56%) also report declining mental health among their patients.
      • “However, only 1 in 10 (12%) Americans regularly see a mental health professional like a psychiatrist, psychologist, psychotherapist, or well-being therapist.” * *
    • “The survey also found that generations have different views of how to access mental health care.
      • “Ninety-five percent of respondents age 57+ agreed that mental health and illnesses should be taken more seriously by society, compared to 8 in 10 respondents aged 18-32 (83%).
      • “About six in 10 (58%) respondents aged 18-32 report that social media has negatively impacted their mental health, compared to just 22% of respondents age 57+.
      • “A higher number of respondents aged 33-40 believe in using technology to access care, with 85% agreeing that digital health services have made mental health more accessible.
  • The U.S. Surgeon General issued an advisory on the healing effects of social connection.
    • “Connection plays a critical role in individual, community, and societal health. This advisory calls attention to that role and offers a framework for how we can all contribute to improving social connection.”

From the U.S. healthcare business front —

  • BioPharma Dive relates
    • “Pfizer on Tuesday reported first quarter revenue that beat Wall Street forecasts despite declining by more than one-fourth compared to the same period in 2022 due to plummeting sales of the company’s COVID-19 vaccine.
    • “Sales of the COVID antiviral Paxlovid, at $4 billion for the quarter, were substantially higher than analysts expected, although the total was tied to the timing of the final delivery under a U.S. supply contract. CFO David Denton told investors that 2023 will be a “transitional” year as Paxlovid distribution shifts from government purchasing to commercial insurance.
    • “Executives affirmed guidance of 7% growth in non-COVID revenues for the full year, higher than the 5% growth in the first quarter. Hitting that target will require successful new drug launches, such as for a respiratory syncytial virus vaccine now under regulatory review and an experimental multiple myeloma treatment. Investors are also looking for better performance from drugs bought via dealmaking, such as the migraine pill Nurtec.”
  • and
    • “Johnson & Johnson has acquired rights to two experimental cell therapies for blood cancer in a move meant to build on the success it’s had developing a CAR-T treatment for multiple myeloma.
    • “The deal, announced Tuesday with the Maryland-based Cellular Biomedicine Group, has J&J paying $245 million upfront to gain access to two CAR-T therapies that have shown positive early-phase results in patients with recurrent diffuse large B cell lymphoma, or DLBCL, the most common form of non-Hodgkin lymphoma.
    • “The agreement increases J&J’s presence in the field of cell therapy. The big drugmaker already sells one treatment, known as Carvykti. The newly added therapies are in early testing or soon will be.  
  • Healthcare Dive reports
    • CVS has closed its acquisition of Oak Street Health for $10.6 billion in cash, pushing the retail health giant further into direct care delivery, CVS announced on Tuesday.
    • With the deal’s completion, CVS adds a multi-state chain of doctor-staffed medical clinics for seniors to its primary care roster.
    • CVS first announced the acquisition, which values Oak Street at $39 a share, in February.
  • On Monday,  “Blue Cross Blue Shield of Michigan and Blue Cross and Blue Shield of Vermont announced an agreement to formally affiliate and work together across both companies. The affiliation will enable the organizations to broaden the range of health plan and service solutions that will further benefit members and customer groups, while remaining within and committed to local communities in both states. The agreement is pending approval of state regulators.”

From the healthcare spending front —

  • Buck Consultants announced
    • “The impact of inflation is not yet fully reflected in medical trend factors, according to Buck, an integrated HR, pensions, and employee benefits consulting, technology, and administration services firm. The findings were released today in Buck’s 44th National Healthcare Trend Survey, a report that identifies trend factors that are used to project employers’ healthcare costs for 2023-2024.
    • “Buck’s annual survey of nearly 100 health insurers and health plan administrators covering more than 100 million plan participants found that while medical trend factors have yet to fully adjust for recent inflationary increases, they continue to increase at a rate consistent with trends reported in the prior survey, which will likely drive healthcare premiums higher in the coming year.
  • Health Payer Intelligence informs us,
    • “Payers with larger market shares tend to have lower prices nationally, a study published in Health Affairs confirmed.
    • “The researchers used data from Turquoise Health, a company that collects hospital price data from the hospitals’ websites, to determine the impact that payer market share can have on prices. The study covered prices for 14 potentially shoppable services with data from 1,446 acute care hospitals. The data was collected through the end of 2021.
    • “Prices were stable within hospitals but not across different payers. And the pricing was dependent, at least in part, on the payers’ market shares. * * *
    • “just as payers can use their market share to negotiate lower prices, the Congressional Budget Office (CBO) found that providers with higher market shares can use their market position to get higher reimbursement out of payers. Hospital consolidation was a key factor in price increases, the CBO report found.”

Monday Roundup

David Ermer–CMS, Congress, End of the PHE, NE, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC, The Wall Street Journal reports

  • “Treasury Secretary Janet Yellen said the U.S. government could become unable to pay all of its bills on time as soon as June 1 if Congress doesn’t first raise the debt limit.
  • “President Biden on Monday invited the top Republicans and Democrats on Capitol Hill to meet next week to discuss raising the country’s roughly $31.4 trillion borrowing limit, the White House said soon after Ms. Yellen’s warning. 
  • “The new estimate released Monday sets a shorter timeline than forecasters had previously expected, putting the U.S. potentially just weeks away from the first default on the U.S. debt. Republicans and Democrats have been debating how to raise the debt ceiling for months, but they have so far made little progress toward reaching an agreement.  * * *
  • “Ms. Yellen said the Treasury’s latest projection was still uncertain. The Treasury could ultimately be able to pay the nation’s bills for several weeks beyond early June, she said. The Treasury tends to be conservative when communicating projected deadlines for possible default.
  • “It is impossible to predict with certainty the exact date when Treasury will be unable to pay the government’s bills,” Ms. Yellen wrote in a letter to House Speaker Kevin McCarthy (R., Calif.).” 

In public health emergency (PHE) news,

  • Govexec informs us “The White House announced on Monday it’s officially ending the COVID-19 vaccine mandates for federal employees and contractors when the public health emergency ends on May 11.”
  • The Centers for Disease Control issued public fact sheets on post-PHE coverage for over-the-counter Covid tests. OPM’s end of PHE guidance requires carriers to continue coverage of these items but allows cost sharing.

From the public health front —

  • The National Institutes of Health announced
    • “Researchers have found the “Eat, Sleep, Console” (ESC) care approach to be more effective than using the Finnegan Neonatal Abstinence Scoring Tool (FNAST) to assess and manage opioid-exposed newborns, according to a national, randomized controlled clinical trial funded by the National Institutes of Health. Newborns cared for with ESC were medically ready for discharge approximately 6.7 days earlier and 63% less likely to receive medication as part of their treatment, compared to newborns cared for with FNAST. ESC prioritizes non-pharmacologic approaches to care, such as a low-stimulation environment, swaddling, skin-to-skin contact and breastfeeding. ESC also encourages parental involvement in the care and assessment of their infants. These findings are based on the hospital outcomes of a large and geographically diverse group of opioid-exposed infants. A two-year follow-up study of a subset of infants is ongoing. The current findings are published in the New England Journal of Medicine.
    • “Medical care for newborns who were exposed to opioids during pregnancy varies widely across hospitals,” said Diana W. Bianchi, M.D., director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which co-led the study with the NIH Environmental Influences on Child Health Outcomes (ECHO) Program. “These findings are an important step toward standard, evidence-based guidance for the care of these infants.”
  • The McKinsey Health Institute evaluates the impact of tech and social media on Gen Z mental health.
    • “Much like many relationships a person might have between ages 18 and 24, the relationship a young person has with social media can be complicated. No matter where they live, respondents in a new global survey said social media usage can lead to a fear of missing out (FOMO) or poor body image, but it also can help with social connections and self-expression.”

From the Rx coverage front, STAT News tells us,

  • “It’s hard to imagine now, but there was a time when obesity was a desert for drug development. Now that drugs originally conceived to control diabetes appear to be such sweeping successes in weight loss, competitors may soon crowd the field. Some candidates may move beyond the current class of GLP-1-based drugs, which mimic the hormone that helps regulate insulin and hunger. 
  • “STAT’s Elaine Chen and Allison DeAngelis explore novel approaches still in development, including some that don’t induce muscle loss, unlike the GLP-1 drugs, and some that mirror the effect of bariatric surgery. Still, among roughly 80 obesity treatments in development, more than half are GLP-1-based, according to tallies by STAT and analysts at TD Cowen. And combination treatments may be the future. Read more.“

From the U.S. healthcare business front,

  • Beckers Hospital Review points out that “Nursing shortages are easing for some hospitals after falling pay from temp agencies and new hospital perks drive more nurses back into permanent positions, The Wall Street Journal reported May 1.”
  • Beckers Payer Issues relates “Molina Healthcare reported double-digit growth in net income since the same period last year and raised its year-end earnings guidance, according to the company’s first-quarter earnings posted April 26.”
  • According to BioPharma Dive
    • “Japanese drugmaker Astellas Pharma on Sunday agreed to acquire Iveric Bio for about $5.9 billion, betting that a medicine the biotechnology company has developed for a common type of vision loss can help it build an eye drug business. * * *
    • “The deal hands Astellas a drug called Zimura that Iveric is studying as a treatment for a form of vision loss known as geographic atrophy. Iveric’s drug already succeeded in a pair of Phase 3 trials and is currently being reviewed by U.S. regulators. A decision is expected by Aug. 19.
    • “Pharmaceutical companies have increasingly turned to dealmaking to help offset patent losses that are soon expected for many of the industry’s top-selling drugs. Over the last two months, drugmakers have spent roughly $65 billion in total on buyouts, led by Pfizer’s $43 billion acquisition of cancer biotech Seagen, according to BioPharma Dive data.”

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.