Monday Roundup

Federal employment benefits

Monday Roundup

David Ermer–Congress, COVID-19, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC —

  • Roll Call tells us “A disagreement between Speaker Kevin McCarthy and House conservatives that jammed up legislative business last week eased Monday evening, but members of the rebel bloc made clear it may not be the end of trouble for their leadership.”
  • Govexec informs us
    • “After multiple years of significant spending increases at non-defense agencies, Congress has reverted to austerity by demanding an overall freeze of discretionary funding for domestic agencies. 
    • “The pullback, agreed to as part of a deal struck by President Biden and House Republicans to meet GOP demands for raising the debt ceiling, will force agencies to make difficult decisions as they abandon some efforts to launch new programs and grow existing ones. The 2023 Fiscal Responsibility Act set only a top-level cap for non-defense spending, leaving it to Congress to establish line-by-line funding levels across government. 
    • “The impacts will look different agency to agency,” said Rachel Snyderman, a senior associate director at the Bipartisan Policy Center and former Office of Management and Budget official.”
  • Federal News Network helpfully reviews the 71 public comments submitted to OPM in response to its April 6, 2023, interim final rule implementing the Postal Service Health Benefits Program.
  • Health Payer Intelligence relates, “AHIP offered four recommendations to the Senate Finance Committee on Consolidation and Competition (the Committee) [last week] to support healthy competition and lower healthcare spending in the healthcare industry.”

From the litigation front —

  • Yahoo News reports,
    • “The Biden administration on Monday finalized a deal to preserve the federal mandate requiring U.S. health insurers to cover preventive care like cancer screenings and HIV-preventing medication at no extra cost to patients while a legal challenge continues.
    • “The agreement, first disclosed on Friday and now finalized in a filing in the New Orleans-based 5th U.S. Circuit Court of Appeals, leaves the mandate in place nationwide while the administration appeals a court order striking it down.
    • “It does allow Texas-based Braidwood Management, one of a group of businesses and individuals that sued to challenge the mandate, to stop covering pre-exposure prophylaxis (PrEP) against HIV and other preventive services for its employees for now. The administration agreed not to take any retroactive enforcement action against the company, which operates an alternative health center if the mandate is restored on appeal.”
  • STAT News adds,
    • “The U.S. Chamber of Commerce sued the federal government over its new Medicare drug-price negotiation program on Friday, arguing that Congress tried to take too much power away from the courts.
    • “The lawsuit is the second to challenge the new program, enacted by Democrats last August in the Inflation Reduction Act, within a week’s time, but relies on different legal reasoning. Merck, which makes a diabetes drug that could be subject to negotiation, sued on Tuesday.
    • “Medicare is supposed to choose the first ten drugs to be negotiated by the program by Sept. 1. The goal of the lawsuits is to slow down or stop the process from going into effect.”

From the public health front —

  • Politico relates,
    • “The FDA’s independent advisers will discuss and recommend this week which strain of SARS-CoV-2 should be included in the newest Covid booster to be rolled out ahead of fall and winter. The FDA doesn’t have to follow its advisers’ recommendations, but it often does.
    • “Since the beginning of the year, the regulatory agency has made it clear that it will shift gears to prepare for annual Covid-19 shots as the virus becomes endemic. Now that we’re four months out from the intended rollout, the FDA must select a strain that will most likely be prevalent so manufacturers can start developing vaccines.
    • “Novavax, Pfizer-BioNTech and Moderna, the companies that manufacture the three vaccines available in the U.S., need the FDA’s recommendations to begin tweaking their existing platforms. They must also conduct clinical trials to show that the updated formulas generate a similar immune response to their existing products.”
  • MedPage Today reports,
    • “Oseltamivir (Tamiflu) has not panned out for reducing the risk of influenza hospitalization, according to a large meta-analysis.
    • “Among over 6,000 flu patients across 15 studies, the 0.14-percentage point difference in hospitalization rate between those who took oseltamivir and those who did not was not significant (RR 0.77, 95% CI 0.47-1.27), Emily McDonald, MD, MSc, of McGill University Health Centre in Montreal, and colleagues reported in JAMA Internal Medicine.
    • “I wouldn’t prescribe it to an otherwise healthy person,” McDonald told MedPage Today. “There was little evidence that it would prevent you from going to the hospital.”
    • “What’s more, she added, “it’s not completely benign. It does cause uncomfortable side effects.”
  • The Wall Street Journal reports,
    • “During the pandemic, Carl Prudhomme of Alpine, Texas, got his cancer drugs mailed directly to him from his oncologist.
    • “No longer. With the end of the Covid-19 public-health emergency, independent cancer doctors can no longer send prescriptions directly to their Medicare patients—creating hurdles for some people in rural areas who say they have to travel to get their medications. Prudhomme plans to drive the 569 miles each way to his oncologist’s office in Houston every three months to pick up his drugs in person.
    • “The Centers for Medicare and Medicaid Services in September 2021 posted a list of frequently asked questions that said independent oncologists can dispense prescriptions only to a patient who is physically in the doctor’s office at the time. 
    • “Sending oral chemotherapy drugs by mail violates the Stark law, the agency said. The law bans doctors from making referrals of Medicare and Medicaid patients to other organizations or medical businesses where they have a financial stake. The restriction also applies to other independent practices, such as urology, that have an on-site dispensing pharmacy.
    • “Roughly 30% of the more than 5,000 independent oncologists in the U.S. have on-site pharmacies in their practices, according to an analysis led by the University of Pennsylvania’s Perelman School of Medicine. 
    • “The restriction was suspended during the pandemic public-health emergency. Its return has alarmed cancer doctors who are lobbying Congress and CMS to rescind the restriction, even if that means undergoing new rule-making to do so.”

From the U.S. healthcare business front —

  • Fierce Healthcare tells us,
    • “Prior authorization has been a flashpoint for providers, and, while insurers have taken steps to ease these utilization management protocols, they still play a key role as the industry shifts to value-based care.
    • “David Brailer, M.D., executive vice president and chief health officer at the Cigna Group, told Fierce Healthcare in an interview that ultimately the goal is to ensure patients are receiving the best treatment option for them.
    • “And the insurer has seen that in more advanced value-based arrangments, it can relax prior authorization and other utilization management tools, Brailer said. 
    • “That’s going to be a few years before the market shifts,” he said. “We’ve already announced that we’re starting to step down the number of prior auths that we have.”
  • STAT News relates,
    • “Novartis said on Monday it would purchase Chinook Therapeutics for $3.2 billion upfront, picking up two drugs for a chronic kidney disease that are in late-stage clinical trials.
    • “The transaction values Seattle-based Chinook at $40 a share, compared to Friday’s closing price of under $24. The agreement includes another $300 million if certain regulatory milestones are reached.”
  • Healthcare Dive points out
    • CVS Health’s decision to shut down its two-year-old clinical trials unit means less competition for the growing group of retailers in research, but the area is still nascent and potentially challenging for new entrants, experts said.
    • “It may sort of spook some pharma companies who may think that if CVS exited, maybe these other companies will also exit, and it may make them a little bit more hesitant to partner up with the retailers,” said Sari Kaganoff, general manager of consulting at Rock Health. “At the same time, there’s a lot of opportunity, we believe, for pharma companies to use retailers for clinical trials.”
    • CVS will fully exit the clinical trials business by the end of 2024, winding down the business in phases and working with trial sponsors to ensure patients continue to receive care. 

From the Rx coverage front —

  • The Wall Street Journal informs us,
    • Kristen Ireland struggled with bulimia nervosa for years, working with a therapist and taking medications for anxiety and depression.
    • It wasn’t until her psychiatrist prescribed Victoza, a diabetes medication that works much like Ozempic, Wegovy and Mounjaro, that her binges and purges faded away.
    • “I feel free now,” said Ireland, 27 years old, who manages sports-merchandise stores in Jackson Hole, Wyo. 
    • Treating eating disorders is another potential application for a class of drugs that has taken the weight-loss world by storm. The drugs, synthetic versions of the GLP-1 hormone that act on appetite centers in the brain and gut, have helped patients lose 15% of their body weight on average
    • Some studies and the experience of doctors in the field suggest they could also help people stop binge eating.
  • CBS News discusses the side effects of these new weight loss drugs.

Friday Factoids

David Ermer–CMS, FDA, Federal employment benefits, Generative AI, Medicare, SDOH, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From the FDA front —

  • MedPage Today tells us
    • “Lecanemab (Leqembi) showed clinical benefit in early Alzheimer’s disease in its confirmatory trial, paving the way for traditional approval of the drug, an FDA advisory committee said Friday.
    • “In a 6-0 vote, the agency’s Peripheral and Central Nervous System Drugs Advisory Committee fully backed the evidence supporting the anti-amyloid monoclonal antibody. * * *
    • “The agency is expected to make its final decision about lecanemab by July 6.
  • KFF provides a cost perspective in anticipation of FDA approval of this drug, which action is expected to trigger CMS approval for Medicare Part B coverage.

From the FEHB front, Tammy Flanagan writing in Govexec delves into FEHB and Medicare Part B coverage.

From the litigation front —

  • The Wall Street Journal reports
    • “Pharmaceutical industry giants completed a deal to pay $19 billion to states that accused them of fueling the opioid crisis, infusing more money into communities still struggling with how to address the scourge of drug use.”
    • “Most states agreed to the deal to settle agreements with manufacturers Teva and Allergan as well as pharmacy chains CVS and Walgreens. The agreement is in addition to a $26 billion so-called global settlement with drug distributors McKesson, Cardinal Health and AmerisourceBergen and manufacturer Johnson & Johnson. The latest settlements close lawsuits against most of the major players and brings the total income from opioid litigation that states will have to spend to about $50 billion. 
    • “The legal fight stretches back nearly a decade, when more than 3,000 lawsuits from states, Native American tribes and counties alleged the drugmakers, pharmacies and distributors played down the risk of painkillers and didn’t stem their flow. Misuse of prescription painkillers sparked a health crisis that was supercharged as fentanyl infiltrated the illicit drug supply and now claims more than 100,000 lives in the U.S. each year. 
    • “Money from the recent settlements will begin to flow to states this year. More than $3 billion from the global settlementhas already been dispersed. The funds are distributed to states based on population adjusted to account for the burden of the opioid epidemic based on deaths and people using drugs. The agreements require most of the money to be spent on abating the opioid crisis, but the parameters are broad and officials are using different strategies to spend it.”
  • KFF has created a tracker to follow the distribution of the opioid litigation settlement funds.

From the CMS front —

  • Healthcare Dive informs us,
    • “CMS is exploring programs that would pay social or community health workers to address patients’ social needs in a bid to invest more heavily in food, housing, transportation and other social determinants of health, according to agency officials.
    • “We are looking at that. For example, in maternal health, thinking about the role of doula and community health workers,” Liz Fowler, director of the Center for Medicare and Medicaid Innovation, said on Thursday during the CMS’ inaugural health equity conference.”
  • and
    • “CMS announced a new model that aims to strengthen and improve primary care, including by ensuring small and rural organizations are able to enter into value-based care arrangements. 
    • “The Making Care Primary Model will run for more than 10 years in eight states — in Colorado, Massachusetts, Minnesota, New Jersey, New Mexico, New York, North Carolina and Washington.
    • “Research shows primary care is key to improving health outcomes and lowering costs. The CMS noted Medicare and Medicaid patients are often diagnosed with multiple chronic conditions, and primary care providers are charged with prevention, screening and management. But, because many patients will see multiple specialists, coordinating care can be challenging.”
  • Fierce Healthcare relates,
    • “The Department of Health and Human Services (HHS) has released a 43-drug list of the Medicare Part B prescription treatments that must repay the program for raising prices above the rate of inflation.
    • “The second quarterly list takes effect in July and is an expansion over the 20 price-capped drugs from April through June. According to HHS, the rebates could save Medicare beneficiaries taking the treatments anywhere from $1 to $449 per average dose in out-of-pocket costs.
    • “The Medicare Prescription Drug Inflation Rebate Program is a critical way to address long-term price increases by drug companies, and [the Centers for Medicare and Medicaid Services (CMS)] is continuing our work to make prescription drugs more affordable for people with Medicare,” CMS Administrator Chiquita Brooks-LaSure said in a release.
    • “The full list of prescription drugs and biological products with adjusted coinsurance amounts for July 1 to Sept. 30 is available here (PDF).
    • “Of note, CMS said the list could be adjusted before or after July 1 based on public feedback notifying the agency of any potential discrepancies, as was the case during the program’s inaugural quarter when a highly publicized list of 27 drugs was later trimmed down to 20.”

From the U.S. healthcare business front —

  • Beckers Hospital Review reports
    • “In the first quarter of 2023, 17 healthcare companies with more than $10 million in liabilities filed for Chapter 11 bankruptcy, a sharp rise compared to seven bankruptcies in the first quarter of 2022, Bloomberg Law reported June 9.
    • “High-profile bankruptcies from Envision, Invacare Corp. and Sorrento Therapeutics contributed to the numbers. The first three months of 2023 saw a slight slump in bankruptcies but remain higher than the same period a year ago.
    • “Despite the year-over-year increase, the first quarter of 2023 still had fewer healthcare bankruptcies than the fourth quarter of 2022.
    • “Once the government money ran out, once all the stimulus dollars around healthcare ran out, there was essentially going to be this backwash,” Timothy Dragelin, a healthcare director at FTI Consulting, told Bloomberg. “The fact that labor costs increased substantially—you also had the issues with supply chain and supply chain caused some disruptions.”
  • Fierce Healthcare tells us
    • “Walgreens Boots Alliance sold its remaining stake in post-acute care and infusion services company Option Care Health for $330 million.
    • “The drugstore chain announced Thursday it sold 10.8 million shares of Option Care Health and plans to use the proceeds primarily for debt paydown, continued support of the company’s strategic priorities and to help fund its healthcare-focused business initiatives, according to a press release.
    • “The transaction is another decisive action WBA is taking to unlock value and further simplify the company’s portfolio,” the company said.
    • “Back in March, Walgreens cut its stake in Option Care Health when it sold 15.5 million shares at $30.75 per share. The transaction reduced Walgreen’s ownership in the company, formerly known as Walgreens Infusion Services, from 14% to 6%, according to a Walgreens news release. “

From the generative AI front —

  • Beckers Hospital CFO Report points out the steps the Google and Microsoft are taking to integrate generative AI in healthcare systems.
  • HR Dive discusses the impact of generative AI on employers and the workplace.

Friday Factoids

David Ermer–Congress, COVID treatment, FDA, Federal employment benefits, OPM, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington DC

  • The Wall Street Journal reports
    • “President Biden said negotiators were closing in on a deal to cut spending and raise the $31.4 trillion debt limit, seeking to overcome final hurdles on issues regarding the budget as well as requiring more people to work to receive federal benefits.
    • “He said talks are “very close” to reaching an agreement and that he was hopeful that there could be a breakthrough as soon as later on Friday. “I hope we’ll have some clear evidence tonight, before the clock strikes 12, that we have a deal,” he said as he departed the White House for Camp David on Friday evening.
    • “Negotiators are hoping to strike a deal soon in order to set up votes on the legislation next week. The Treasury Department, which is currently using extraordinary measures to avoid exceeding the debt ceiling, estimated Friday that the government could run out of money to pay its bills if Congress doesn’t act by June 5.
    • “Treasury had previously put the deadline as early June, saying it could come as soon as June 1. Any legislation would likely take at least several days to pass both the House and Senate.
  • Govexec tells us
    • “The federal government’s HR agency on Wednesday unveiled new guidance aimed at standardizing and revitalizing employee assistance programs across the federal government, an effort officials said would prioritize employee wellness and improve productivity.
    • “Like many private sector employers, federal agencies often offer employees access to employee assistance programs, which provide services related to maintaining one’s mental and physical health, as well as resources related to substance use issues.
    • “The Office of Personnel Management, spurred by a provision of President Biden’s management agenda tasking agencies with promoting “awareness of employee well-being and [supporting] initiatives that extend beyond the workplace,” underwent a year-long effort to design a “standardized approach” to employee wellness programs, consulting with focus groups, health experts and vendors who provide assistance programs to employers.
    • “The result is a 19-page guidance document for agencies to reassess their assistance program offerings and, if necessary, expand them.
  • The FEHBlog wonders why OPM silos its various benefit programs rather than integrate them to get more bang for the buck.

From the healthcare costs front —

  • Milliman has released its 2023 Medical Index. Milliman estimates the healthcare cost for a hypothetical family of four enrolled in a hypothetical PPO plan is $31,065, a 5.6% increase over 2022.
  • The Medical Group Management Association issued its 2023 Physician Compensation and Productivity Benchmarks.
    • “Productivity remained relatively flat or only slightly increased relative to pre-pandemic benchmarks, with the biggest change in work RVUs posted in dermatology, hematology/oncology, and family medicine (without OB). 
    • “The growth in median total compensation for primary care physicians (PCPs) doubled from 2021 (2.13%) to 2022 (4.41%), but was outpaced by inflation at 7% and 6.5%, respectively. 
    • “Surgical and nonsurgical specialists saw their change in median total compensation cool slightly in 2022, dropping from 3.89% for surgical specialists in 2021 to 2.54% in 2022, and from 3.12% for nonsurgical physicians in 2021 to 2.36% in 2022. 
    • “APPs [advanced practice providers]— who saw the biggest change in median total compensation from pre-pandemic levels — saw their 2022 growth ebb slightly to 3.70%, down from 3.98% growth in 2021.” 

From the U.S. healthcare business front,

  • Beckers Hospital Review points out
    • “There are 293 rural hospitals at immediate risk of closure due to inflation, staffing shortages and other financial stress, according to the Center for Healthcare Quality & Payment Reform. 
    • “Hospitals at immediate risk of closure have lost money on patient services for multiple years, excluding 2020 during the pandemic, and aren’t likely to receive sufficient funds to cover the losses with public assistance ending, according to the report. These hospitals also have low reserves and more debt than assets.”
  • MedCity News relates
    • “The pandemic prompted a great need for technology-enabled care delivery, so the regulations surrounding reimbursement for these services were tossed out the window in 2020. Now that the public health emergency has ended, the healthcare industry has to figure out how it is going to pay for digital health services going forward.
    • “It’s clear that services like telehealth and remote patient monitoring have potential to provide value, but hospitals and digital health companies need to show payers clearer evidence of the outcomes these care modalities can produce, panelists argued during a Wednesday session at MedCity News’ INVEST conference in Chicago.” 
  • STAT News adds market perspective on the Food and Drug Administration’s full approval of Paxlovid, announced yesterday.
    • “The full approval for treating adults at high risk of progression to severe disease will help Pfizer expand its marketing campaign. U.S. officials plan to work through much of the government’s Paxlovid inventory, which is available for free at pharmacies around the country, before moving to a normal commercial market for the drug. Pfizer has sold the U.S. government nearly 24 million courses at around $530 a course, but it is not clear yet what price the company will charge.”

From the interoperability front —

  • The Pharmacy Times tells us
    • “Integrating Immunization Information Systems (IIS) vaccination records into claims data (collected by health insurers) increased the number of people identified as being vaccinated against COVID-19, according to the results of a study published in JAMA Network Open. Having accurate COVID-19 vaccination data is important for future COVID-19 vaccine studies that capture efficacy and safety, according to the study.
    • “When claims data were supplemented with IIS vaccination records, the proportion of participants with at least one vaccine dose rose from 32.8% to 48.1%. And when IIS vaccine records were included with claims data, the percentage of people who completed a vaccine series increased from 24.4% to 41.9%, varying by state.”
  • Per FCW
    • The Food and Drug Administration is looking to develop standardized “supersets of data” and improve data interoperability, analysis and management across the agency, an official said on Wednesday. 
    • The agency is planning to gather information and seek public input on the use of real-world data in its decision-making processes, according to Jose Galvez, deputy director for the office of strategic programs of the FDA’s Center for Drug Evaluation and Research. 
    • Galvez said at the Professional Services Council 2023 FedHealth Summit that the FDA is set to release a Federal Register notice “very shortly” to gain industry input on evaluating new types of data analysis.

Monday Roundup

David Ermer–Congress, Federal employment benefits, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC, the Wall Street Journal reports

“President Biden and House Speaker Kevin McCarthy (R., Calif.) opened a high-stakes meeting on Monday evening, as negotiators worked to get back on track on reaching a debt-ceiling deal that could pass both the Republican-led House and Democratic-led Senate by the end of the month. 

“Central to the talks is setting a top-line spending level for the next year and deciding how long to lift the debt ceiling until having to raise it again. The two sides are aiming to reach a deal by June 1, when the Treasury Department estimates the U.S. could run out of money to pay all of its bills, leading to a first-ever default. Treasury Secretary Janet Yellen repeated that estimate Monday.”

About 90 minutes later, Politico adds, “President Joe Biden and Speaker Kevin McCarthy ended their one-on-one meeting Monday [with a “better tone” yet] still short of a deal to avoid a U.S. debt default that could come as soon as June 1.”

From the Rx coverage front —

  • STAT News informs us,
    • “An oral version of semaglutide, the drug marketed as Ozempic and Wegovy, led to dramatic weight loss in a trial enrolling people with obesity, manufacturer Novo Nordisk said Monday, data that could bolster what is already a blockbuster medicine.
    • “In the study, which enrolled nearly 700 adults classified as overweight or obese, patients treated with a daily semaglutide tablet lost 15.1% of their body weight over the course of 17 months, while those on placebo lost 2.4%, Novo Nordisk said. The result is comparable to weekly injections of Wegovy, which in an earlier study led to 14.9% weight loss over the same period of time. In both studies, the most common side effects were gastrointestinal distress, with the majority of cases graded mild or moderate, the company said.
    • “Novo Nordisk said it plans to submit oral semaglutide for U.S. and E.U. approvals later this year. A lower-dose version of the drug is already approved as a treatment for type 2 diabetes under the brand name Rybelsus.”
  • Reuters tells us,
    • “Taking Novo Nordisk’s new obesity drug may help reduce the risk of heart disease as well as boosting weight loss, according to new research from the United States.
    • “After a year of taking semaglutide, marketed as Wegovy, patients’ risk of suffering from conditions like a heart attack or a stroke over the next ten years dropped to 6.3% from 7.6% when measured by a commonly used calculator, researchers at the Mayo Clinic found.
    • “The results, which were presented this week at the European Congress on Obesity in Dublin, are among the first indication that the weight loss induced by the new GLP-1 agonist drugs like Wegovy also brings heart health benefits – something scientists expected, but do not yet have much comprehensive data to prove.
    • “The study was only done among 93 patients, and the researchers said that more and larger studies were needed to see if the risk reduction score actually meant less illness and death long-term.
    • “Novo is expected to release results from its 5-year SELECT trial looking into the health impact of its injectable drug, particularly around heart disease, later this year. Investors, governments and insurers alike are keenly watching the data.
  • FiercePharma offers a special report about the most expensive drugs in our country.

From the U.S. healthcare business front —

  • Fierce Healthcare relates
    • Found, a company that offers an evidence-based weight loss management program for consumers, is launching a new platform that aims to help employers manage services and cost for workers struggling with weight, including GLP-1 drugs like Ozempic and Wegovy.
    • With medication-assisted obesity care in the headlines, Found for Business offers employers a solution that’s based on clinical best practices and is cost-effective and medication-agnostic. Found’s approach combines virtual clinical care with personalized medication regimens and behavioral health change, according to an announcement
  • Healthcare Dive reports
    • HCA Healthcare, one of the nation’s largest for-profit health systems, has agreed to acquire 41 urgent care centers in Texas.
    • The deal includes 19 FastMed and 22 MedPost clinics in Dallas, Austin, San Antonio, Houston and El Paso, HCA said Thursday.
    • Terms of the deal were not disclosed, but the buy is expected to close this summer, according to the operator.

In federal employee benefits news

  • OPM released “the OPM Retirement Quick Guide, a three-page guide to voluntary retirement that walks federal employees through what to expect as a retirement application is processed and benefits are determined, including helping employees estimate when they can expect to receive their interim and first annuity payments. OPM Retirement Services (RS) developed the guide in partnership with the Lab at OPM, using human-centered design principles.” 
  • Federal News Network discusses “OPM’s new approach to modernizing retirement services [which] is all about small bites.”

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.”

Friday Factoids

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

Today marks the final issue of the CDC’s weekly interpretative review of its Covid statistics. The final issue advises

“The latest updates to CDC’s COVID Data Tracker reflect these changes. The homepage has a new look, and there are also new landing pages for hospitalizations, emergency department (ED) visits, and death data, as well as visualizations of trends and maps. Several pages have also been retired, but COVID Data Tracker has a page with links to archived data and visualizations.

“These are the most notable changes to COVID Data Tracker:

  • Hospital admission rates and the percentage of COVID-19 deaths among all deaths are now the primary surveillance metrics.
  • COVID-19 hospital admission levels replace COVID-19 Community Levels (CCLs) as the main indicator of county trends. COVID-19 hospital admission levels are comparable with CCLs.
  • Provisional death certificate data from the National Vital Statistics System (NVSS) will become the primary source for mortality surveillance, replacing aggregate death counts.
  • Aggregate case and death count reporting has been discontinued.
  • ED visit data will serve as an early indicator of COVID-19 activity.”

The Wall Street Journal reports on the ongoing struggles of people afflicted with long Covid.

From the public health front –

  • In recognition of Mothers’ Day this weekend, the CDC encourages pregnant women to get a flu shot (not the nasal flu vaccine spray).
  • MedPage Today tells us that “The CDC reported that the nation’s first-ever cases of treatment-resistant ringworm were identified in New York City. (Morbidity and Mortality Weekly Report)
  • The Department of Health and Human Services celebrated “the first anniversary of the National Maternal Mental Health Hotline. Since being launched on Mother’s Day 2022 by the Health Resources and Services Administration (HRSA), the hotline’s professional counselors have provided emotional support, resources, and referrals to almost 12,000 pregnant and postpartum individuals struggling with mental health concerns, and their loved ones.  Additionally, HRSA is introducing an updated, more user-friendly toll-free number for the Hotline: 1-833-TLC-MAMA (1-833-852-6262).”

From the Rx coverage front —

  • The Food and Drug Administration announced “approving Veozah (fezolinetant), an oral medication for the treatment of moderate to severe vasomotor symptoms, or hot flashes, caused by menopause. Veozah is the first neurokinin 3 (NK3) receptor antagonist approved by the FDA to treat moderate to severe hot flashes from menopause. It works by binding to and blocking the activities of the NK3 receptor, which plays a role in the brain’s regulation of body temperature.”
  • Mercer Consulting offers advice to employers and health plans on how to help employees and members address drug shortages.
  • Biopharma Dive reports
    • “A group of Food and Drug Administration advisers narrowly supported approving what could be the first gene therapy for Duchenne muscular dystrophy in a meeting Friday, clearing the way for the agency to make a closely watched decision later this month.
    • “By an 8-6 vote, the panel recommended that the treatment, developed by biotechnology company Sarepta Therapeutics, be granted an “accelerated” approval. The close vote reflected a daylong back-and-forth over the treatment, and whether the protein it’s designed to produce in the body — called microdystrophin — is reasonably likely to benefit people with Duchenne who can still walk. * * *
    • “The FDA usually follows the advice of its advisory committees, but isn’t required to do so. The agency is set to make its decision by May 29.
    • “While far from unanimous, the panel’s recommendation could make that decision easier, and marks an important moment for a Duchenne patient community that has long advocated for gene therapy.”

From the federal employee benefits front, NARFE informs us that.

  • “Effective May 1, 2023, the US Office of Personnel Management (OPM) extended its contract with John Hancock to provide insurance coverage to all Federal Long Term Care Insurance Program (FLTCIP) enrollees. Although OPM solicited multiple bids, John Hancock remained the sole bidder. The program administrator, Long Term Care Partners LLC, has mailed notice of this action to enrollees.  
  • “Per the extended contract, most enrollees should expect to face a premium increase effective January 1, 2024. In September 2023, each enrollee will be offered personalized options that will include accepting the premium rate increase to maintain current coverage or to reduce coverage to reduce the impact of any increase. OPM indicated that premium increases would be phased in over three years for some options.  
  • No additional information on the premium increases or personalized options is available currently.” 

From the bravery department, Govexec points out that the National Association of Letter Carriers named two dozen letter carriers were named as heroes of the year for taking life-saving actions on the job. Bravo!

From the healthcare spending front, Fierce Healthcare informs us

  • “The anti-dementia medication lecanemab will come with an extraordinarily high price tag if the Centers for Medicare & Medicaid Services (CMS) decides to cover it, according to a research letter in JAMA Internal Medicine.
  • “Researchers at RAND estimate that covering the drug and other associated services could add between $2 billion and $5 billion in annual Medicare costs. This could also lead to “substantial out-of-pocket costs for beneficiaries lacking supplemental coverage,” the researchers said.
  • :Those out-of-pocket costs could be as much as one-fifth of the annual income for a Medicare beneficiary, according to the study. The medication, developed by Eisai and Biogen, costs $26,500 a year, including treatment add-ons such as imaging.”

Whoa, Nelly. Thank heavens OPM is allowing FEHB carrier to offer Medicare Part D EGWPs next year.

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.”

 

  

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.

Friday Factoids

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

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

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

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

From the U.S. healthcare business front —

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

From Capitol Hill, STAT News reports,

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

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

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

    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.