Weekend update

Congress

Weekend update

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

The FEHBlog is back in DC this week.

And speaking of Washington, DC —

  • The U.S. Supreme Court has ten decisions to issue from its October 2022 term. Last week, the Supreme Court issued seven decisions. Its next decision day is Tuesday, June 27.
  • Last Friday, the President issued an Executive Order on Strengthening Access to Affordable, High Quality Contraception and Family Planning Services.
    • “Sec. 2.  Improving Access and Affordability Under the Affordable Care Act.  (a)  The Secretaries of the Treasury, Labor, and Health and Human Services (Secretaries) shall consider issuing guidance, consistent with applicable law, to further improve Americans’ ability to access contraception, without out-of-pocket expenses, under the Affordable Care Act.  In doing so, the Secretaries shall consider actions that would, to the greatest extent permitted by law:
    •           “(i)   ensure coverage of comprehensive contraceptive care, including all contraceptives approved, granted, or cleared by the Food and Drug Administration, without cost sharing for enrollees, participants, and beneficiaries; and
    •           “(ii)  streamline the process for patients and healthcare providers to request coverage, without cost sharing, of medically necessary contraception.
    •      “(b)  The Secretaries shall consider additional actions, as appropriate and consistent with applicable law, to promote increased access to affordable over-the-counter contraception, including emergency contraception.”
  • From the public health / medical research front –
  • Bloomberg Prognosis offers guidance on Covid boosters.
    • In April, a CDC advisory committee on immunization practices showed just how rapidly we can lose the protections vaccines offer, Wallace points out. A review of data from 20 states revealed the bivalent booster’s effectiveness in those 65 and older fell to 65% in the first two months. That dropped to 45% in four months and plummeted to 22% in six months.
    • Those numbers are part of the reason higher-risk people are offered second doses of the bivalent shot.
    • “If people are in these groups, I would not hesitate to take advantage of this additional protection, as well as considering taking other prevention strategies, like masking in indoor public spaces,” says Wallace.
    • If you’re unsure, a healthcare provider can explain which dosing strategy is right for you. 
  • Medscape informs us
    • Can common anti-depressants prevent COVID-19 infection? That’s the suggestion of research in BMC Medicine, based on infection trends among more than 5,600 mental health care patients in the United Kingdom from April to December 2020.
    • The report says that selective serotonin reuptake inhibitors (SSRIs) were particularly effective in blocking COVID-19 transmission.
    • “Mental health patients with a recent (previous 90 days) prescription for an SSRI had an almost 40% reduction in the likelihood of a positive COVID-19 test,” wrote the Center for Infectious Disease Research & Policy (CIDRAP) at the University of Minnesota.
    • Research showed that 27.7% of COVID-19-negative patients had taken at least one antidepressant medication within the last 90 days before they were admitted to a mental health care facility, compared to just over 16% of COVID-19 positive patients.  * * *
    • “The results of this study hint at the potential clinical benefit” of SSRIs on COVID-19 infection, said the lead author, Oleg Glebov of King’s College London, in a press release.
  • The Raleigh News Observer reports
    • “Until recently, if a heart stopped beating, it couldn’t be donated. Donor hearts typically come from patients determined to be brain dead, from which doctors can extract the beating organ and transplant it into its new owner. But a new study from Duke researchers found that using a heart that has been “reanimated” by a machine works just as well as traditional transplants. This method could expand the pool of heart donors by 30%, said Dr. Adam DeVore, a Duke researcher and author on the paper. DeVore said this method allows doctors to salvage hearts from a group of patients who previously had been unable to donate.
    • “Duke’s own heart transplant clinic has greatly benefited by drawing from this new pool of donors. DeVore said the program has doubled in size in the last year, which he credits in part to the new method.”
  • Emergency room physician Edwin Leap writes in his blog that heart attacks are on the rise in younger people.
    • “While I certainly try not to inflame anyone’s fears, I write this to say that people should be attentive to their symptoms. Even a person who is relatively young should be cautious if they have chest pain, difficulty breathing, profound weakness or dizziness/passing out. Of course, associated symptoms can include nausea, unexpected sweating (or diaphoresis), numbness or tingling in arms or face, or pain into jaw, neck or back. Of course, symptoms in women can be more subtle can can simply involve profound fatigue.
    • “What may be equally important is the idea that we should be take good care of ourselves. In the face of an increased level of risk for heart disease, it’s a good time to lose weight, exercise, stop smoking and eat a healthy diet. I would also suggest that everyone take their existing prescriptions, try hard to control their blood glucose in diabetes, manage their blood pressure and all the rest. We can’t control all of our health risks, but the ones which we can, we certainly should.
    • “Furthermore, even young people should find a primary care physician if possible, and establish a relationship with that physician. The screening exams that they perform, the regular exams, the attention to your health that they provide can truly be lifesaving.”
  • In the FEHBlog’s view, health plans should help all of their members connect with a primary care physician. Leverage that network.

From the Rx coverage front —

  • The Wall Street Journal confirms‘ that Novo Nordisk is preparing to request Food and Drug Administration approval for a Wegovy weight loss pill.
    • “Later this year, Novo Nordisk plans to ask U.S. and European drug regulators to approve the tablet.  Novo already sells a tablet form of semaglutide, Rybelsus, to treat Type 2 diabetes, though some people use it off-label for weight loss.
    • “Novo Nordisk’s Ozempic and Wegovy therapies and Lilly’s Mounjaro have emerged as viral sensations—touted by celebrities and discussed on Facebook and TikTok—because of their potential to help people lose significant weight.
    • “These types of drugs, first approved to treat diabetes, work by mimicking gut hormones that play a role in regulating blood sugar and, it has turned out, appetite. A key gut hormone is called glucagon-like peptide-1, or GLP-1. * * *
    • “BMO Capital Markets analyst Evan David Seigerman estimated that pill forms of weight-loss drugs could make up about 15% of the total market, which he predicts will reach $100 billion in annual sales worldwide in coming years.”

From the wellness front —

  • Fortune Well interviews longevity expert Dr. Peter Attia.
    • While Dr. Peter Attia, author of New York Times bestseller Outlive: The Science and Art of Longevity, said there’s no “silver bullet” to increase one’s health span and life span, there are still a variety of longevity-linked habits that may work for you to stave off age-related disease and early mortality. 
    • “People have so much more agency over this than they will ever believe if they don’t take the step to educate themselves on it,” Attia tells Oprah Winfrey this week for a series called The Life You Want on Oprah Daily. “A lot of people think, ‘Well, this is my lot in life’…It’s not the case at all.”
    • Exercise, nutrition, sleep, and managing emotional health by engaging with others and trying new hobbies are all associated with a longer, healthier life. 
    • For Attia, moving without distraction and staying outside is his secret sauce. 
  • and
    • offers guidance on the best timing for dinner from a health standpoint.
  • The Wall Street Journal discusses the health importance of controlling salt intake.

Thursday Miscellany

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

From Washington, DC —

  • The Senate Finance Committee informs us
    • “U.S. Senate Finance Committee Ranking Member Mike Crapo (R-Idaho) and Finance Committee member Michael Bennet (D-Colorado), along with Finance Committee members Tim Scott (R-South Carolina) and Ben Cardin (D-Maryland), are reintroducing legislation that would provide Medicare coverage for screening tests to save lives and costs to the health care system. 
    • “The Medicare Multi-Cancer Early Detection (MCED) Screening Coverage Act would ensure Medicare patients have coverage for innovative tests that can detect multiple types of cancer before symptoms develop.  Bipartisan companion legislation (H.R. 2407) was also introduced in the U.S. House of Representatives.”  
  • Here’s a link to the National Cancer Institute’s FAQs on multi-cancer detection tests.
  • The American Hospital Association reports
    • “A bipartisan group of 233 representatives and 61 senators yesterday called on the Centers for Medicare & Medicaid Service to enhance its proposal to streamline prior authorization processes in Medicare Advantage, Medicaid and the federally-facilitated Marketplace to require real-time electronic decision-making for routinely approved services, responses for emergency procedures within 24 hours and additional transparency. They said adding these provisions would better align the rule with the Improving Seniors’ Timely Access to Care Act, House-passed legislation supported by the AHA to streamline prior authorization in the MA program, and urged CMS to quickly finalize the rule with these updates.
    • “AHA also has urged CMS to quickly finalize the proposed rule, adequately enforce and monitor the requirements and test and vet any electronic standards before mandating their adoption.”
  • Govexec.com tells us
    • “President Biden’s plan to provide civilian federal employees with an average 5.2% pay raise in 2024 appears safe for now, as a key House panel advanced spending legislation that does not address federal employee compensation.
    • “But Democrats and federal employee groups blasted the GOP-led appropriations package, which cuts spending on financial agencies and government administration by 58% compared with fiscal 2023 levels and includes policy riders restricting telework at federal agencies and targeting transgender federal workers and their family members.
    • “The House Appropriations Committee’s Financial Services and General Government Subcommittee on Thursday advanced its annual appropriations bill—one of 12 such pieces of legislation covering different areas of government—to the full committee.”
  • The EEOC reminds us
    • “The Pregnant Workers Fairness Act (PWFA) is a new law that requires covered employers to provide “reasonable accommodations” to a worker’s known limitations related to pregnancy, childbirth, or related medical conditions unless the accommodation will cause the employer an “undue hardship.”
    • “The PWFA applies only to accommodations. Existing laws that the EEOC enforces make it illegal to fire or otherwise discriminate against workers on the basis of pregnancy, childbirth, or related medical conditions.
    • “The PWFA does not replace federal, state, or local laws that are more protective of workers affected by pregnancy, childbirth, or related medical conditions. More than 30 states and cities have laws that provide accommodations for pregnant workers.”
  • The new law takes effect on Tuesday, June 27, 2023.
  • STAT News explains why five cases have been filed in federal district courts challenging the constitutionality of the Inflation Reduction Act’s authorization for CMS to negotiate Medicare drug prices.
    • “The pharmaceutical industry has been filing a lawsuit here, there, and pretty much everywhere.
    • “Drugmakers lost a two-decade long lobbying fight in Congress last summer when Democrats gave Medicare more power to choose what it pays for prescription drugs. Now, they’re taking their battle to the courts.
    • “Merck filed suit in the District of Columbia. Bristol Myers Squibb filed in New Jersey. The Chamber of Commerce filed in Ohio. PhRMA filed in Texas. And there’s no reason to believe the barrage of lawsuits will stop anytime soon.
    • “They’re dividing and conquering to advance different legal arguments. The Merck and Bristol Myers Squibb lawsuits were strikingly similar. They relied on the same legal reasoning, and were filed by the same firm and a few of the same attorneys, even. The PhRMA and Chamber of Commerce suits advanced different arguments that were also similar to each other.
    • “The scattershot approach, according to legal experts, increases the industry’s chance of producing conflicting decisions that the Supreme Court would have to resolve.”

From the public health front —

  • Healthcare Dive points out
    • “From 2019 to 2021, preventable deaths in Louisiana, Mississippi, Texas and New Mexico climbed by more than 35%, and the rates in Arizona increased by 45%, according to nonprofit Commonwealth Fund’s 2023 Scorecard on State Health System Performance released Thursday. The report attributes the increase in deaths mostly to the COVID-19 pandemic.
    • “The mortality rate for women in their reproductive years (age 15 to 44) rose nearly 40% due to maternal deaths, COVID-19, and substance misuse.
    • “Massachusetts, Hawaii, New Hampshire, Rhode Island and Vermont had the best overall health system performances while states in the Southeast and South Central regions ranked the lowest. Those included Arkansas, Texas, Oklahoma, West Virginia and Mississippi.”
  • Here’s a link to the scorecard.
  • The Department of Health and Human Services announced
    • “A large nationally representative study shows in-hospital delivery-related maternal mortality rates improved 57% between 2008 and 2021, despite identified increases in severe maternal morbidity (SMM). This observational study of over 11 million hospital discharges, conducted by the HHS Office on Women’s Health (OWH) and published in JAMA Open Network, intends to more clearly define trends and risk factors leading to maternal mortality and morbidity in the United States and to improve overall national prevention and treatment efforts.
    • “This decline in deaths during delivery hospitalization likely demonstrates the impact of national and local strategies to improve the quality of care by hospitals during delivery-related hospitalizations. This includes HHS quality improvement activities such as state Perinatal Quality Collaboratives and the Alliance for Innovation on Maternal Health, and ties into the Administration’s commitment to addressing the maternal health crisis, with the United States facing some of the highest maternal death rates among developed nations.”
  • The Wall Street Journal reports
    • “Severe fungal disease used to be a freak occurrence. Now it is a threat to millions of vulnerable Americans, and treatments have been losing efficacy as fungal pathogens develop resistance to standard drugs. 
    • “Medical experts say one reason for the surge is that more people have compromised immune systems, including cancer patients and those taking medicines after organ transplants. Compounding the problem, research shows, is that rising temperatures appear to have expanded the geographical range of some deadly fungal pathogens and possibly made them better adapted to human hosts.
    • “It’s going to get worse,” said Dr. Tom Chiller, head of the fungal-disease branch of the Centers for Disease Control and Prevention.
    • “The failure of some doctors to recognize quickly enough what is happening to stricken patients is causing deaths and complications they could have prevented.
    • “Fungi aren’t being given enough thought,” said Dr. Peter Pappas, an infectious-disease specialist at the University of Alabama at Birmingham. “When symptoms can’t be explained, fungi should be one of the first things you think about.”

From the Rx coverage front —

  • STAT News reports
    • The Food and Drug Administration granted conditional approval Thursday to the first gene therapy for Duchenne muscular dystrophy. Regulators restricted the treatment to younger patients, with additional data required to broaden its use.
    • The gene therapy, called Elevydis, is made by Sarepta Therapeutics. The company will charge $3.2 million for the treatment, making it the U.S.’s second most expensive drug, behind a recently approved gene therapy for hemophilia. CEO Doug Ingram said on a conference call the price was below what a recently published company-funded analysis found would be cost-effective.
  • Here’s a link to the FDA announcement, which includes more details.

Midweek Update

David Ermer–CDC, Congress, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC —

  • STAT News reports
    • “Republican Sen. Chuck Grassley wants to see his party’s leadership turn up the pressure on pharmacy benefit managers.
    • “They talk in such generalities on this subject that it’s difficult for me to tell where they’re coming from,” he said at a STAT event Wednesday, speaking about top GOP senators’ approach to reforming the drug pricing middlemen who negotiate between pharmaceutical companies and insurers. “We’re hearing… ‘We don’t want to do something splitting the caucus.’ But we’ve got a major problem here with PBMs deciding rebates, deciding the price of drugs, probably being an instrument to drive up the price of drugs, and nobody knows what they’re doing.”
    • “Grassley has reason to push urgency. The Senate leaves this weekend for a July recess, and when they return next month, lawmakers have just over two weeks of working days in the Capitol before a monthlong AugusSt break. Multiple drug pricing priorities hang in limbo.”
  • The Federal Times adds
    • “The House’s fiscal 2024 funding plan for federal civilian agencies would force agencies to roll back telework, keep abortion out of employee health insurance plans and make pay contingent on compliance with Congressional demands.
    • “The Financial Services and General Government Appropriations bill, which will be considered in a hearing Thursday, sets funding for more than two dozen independent agencies, including the Internal Revenue Service and White House offices, for the government fiscal year that starts Oct. 1, according to an executive summary released Wednesday.”
  • STAT News informs us
    • “A panel of experts that advises the Centers for Disease Control and Prevention on vaccinations opted Wednesday not to recommend that all seniors get a vaccine to protect against RSV.
    • “Instead, the Advisory Committee on Immunization Practices said that anyone 60 and older should be able to get one of the new vaccines — being brought to market by GSK and Pfizer — if they and their physicians think it would be worthwhile.”

From the public health front —

  • The National Cancer Institute advises
    • “A new study has found an effective way to help women in rural towns get screened for cancer. But the study didn’t zero in on just one kind of cancer screening. Instead, the researchers tried simultaneously boosting all of the cancer screenings women need—breast, cervical, and colorectal. And a randomized clinical trial of the approach showed that it worked.
    • “In the trial, providing rural women with an interactive video of tailored messages about cancer screening plus a phone call with a patient navigator was the most effective way of getting them up to date on all three cancer screeningsExit Disclaimer. 
    • “Results of the study, which included nearly 1,000 women living in rural parts of Indiana and Ohio, were published April 28 in JAMA Network Open.
    • “The basic message is: Health care providers can, and probably should, address all screenings needed at the same time,” said study co-leader Victoria Champion, Ph.D., R.N., of Indiana University Melvin and Bren Simon Comprehensive Cancer Center.”
  • and
    • “New cases of colorectal cancer in people under the age of 50 have been rising at an alarming rate over the past several decades. But younger adults aren’t routinely screened for colorectal cancer because the disease is still relatively rare in younger adults. 
    • “Now, a study has identified four warning signs that, according to the investigators, could help encourage younger adults to seek medical care so they can potentially catch the disease at an earlier and more treatable stage. 
    • “To conduct the study, the research team analyzed insurance claims data on more than 5,000 people diagnosed before age 50, called early-onset colorectal cancer, and more than 22,000 people without cancer (controls).
    • “The analysis showed that, in the period of 3 months to 2 years before people with colorectal cancer were diagnosed, four signs were more commonly reported in people who developed colorectal cancer than in matched controls:
      • abdominal pain
      • rectal bleeding
      • diarrhea
      • iron deficiency anemia
    • “Having just one of these signs during this period was associated with nearly twice the likelihood of being diagnosed with early-onset colorectal cancer as having none of the signs.
    • “Having three or more of these signs was associated with six times the likelihood of being diagnosed with the disease. The findings were published May 4 in the Journal of the National Cancer Institute.”
  • STAT News reports “Xylazine or ‘tranq’ is making opioid overdoses harder to reverse.”
    • “Six years ago, when you would hit somebody with naloxone, they would be very responsive,” said Sarah Laurel, the executive director of Savage Sisters, a Philadelphia nonprofit that provides resources and care to people who use drugs. But more recently, she said, “I started noticing that my friends, when we would hit them with Narcan, they weren’t responsive. Their color was not returning, and they weren’t beginning to breathe on their own.”
    • “When responding to an overdose in the xylazine era, Laurel said, the new priority is simple: oxygen. Emergency responders and harm-reduction workers are increasingly using whatever tools and techniques they have available to make sure oxygen is reaching overdose victims’ brains, including mouth-to-mouth breathing and oxygen masks.
    • “Amid the fast-changing landscape, doctors, first responders, public health officials, and nonprofits have scrambled to formalize their new overdose-response protocols. At the same time, they have worked to draw up new instructions for bystanders who encounter an overdose in progress. They are, in essence: Administer naloxone, call 911, and then immediately start “rescue breathing” to ensure the overdose victim doesn’t die or experience hypoxic brain injury before emergency responders arrive.
    • “Recent guidance from the Philadelphia Department of Public Health encourages overdose responders to provide supplemental oxygen and employ “airway management” techniques — essentially, manipulating the head, neck, and body to ensure breathing isn’t blocked.”
  • HHS announced
    • The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), issued a new advisory today: Identification and Management of Mental Health Symptoms and Conditions Associated with Long COVID.
    • “Long COVID has a range of burdensome physical symptoms, and can take a toll on a person’s mental health. It can be very challenging for a person, whether they are impacted themselves, or they are a caregiver for someone who is affected,” said HHS Secretary Xavier Becerra. “This advisory helps to raise awareness, especially among primary care practitioners and clinicians who are often the ones treating patients with Long COVID.”
  • and
    • “The Biden-Harris Administration today announced a public-private partnership between the U.S. Department of Health and Human Services (HHS) and Upstream to expand access to contraception, an essential component of reproductive health care, and address the growing disparities in women’s health in the U.S.”

From the plan design front —

  • Health Payer Intelligence points out
    • “Payers should consider program design intensity when implementing value-based purchasing contracts, as higher-intensity programs can lead to better care quality and greater spending reductions, a systematic review published in Health Affairs found.
    • “Value-based purchasing programs can incorporate both financial and non-financial features. Financial aspects include bonuses, penalties, and financial risk-sharing arrangements.
    • “Non-financial aspects aim to help providers respond to the spending and quality incentives in a VBP program. These include analyzed data, reports, or lists; technical assistance through leadership or change management training, infrastructure payments to add more staff; raw claims data; risk-management support; and care management support.
    • “Different combinations of financial and non-financial supports can lead to varying levels of program intensity.”
  • The Wall Street Journal reports
    • Food and insurance companies are exploring ways to link health coverage to diets, increasingly positioning food as a preventive measure to protect human health and treat disease.
    • Insurance companies and startups are developing meals tailored to help treat existing medical conditions, industry executives said, while promoting nutritious diets as a way to help ward off diet-related disease and health problems.
    • “We know that for adults, around 45% of those who die from heart disease, Type 2 diabetes, stroke, that poor nutrition is a major contributing factor,” said Gail Boudreaux, chief executive of insurance provider Elevance Health speaking at The Wall Street Journal Global Food Forum. “Healthy food is a real opportunity.”

Happy Juneteenth

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

Mercer Consulting offers us this background

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

Mercer Consulting adds

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

From Washington, DC —

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

Healthcare Dive reports

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

From the MD opinion front —

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

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

From the semaglutide drug front —

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

From the miscellany front –

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

Thursday Miscellany

David Ermer–Congress, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, D.C.

  • Politico tells us,
  • “The House Energy and Commerce Committee will examine how Medicare pays doctors, Robert King reports.
  • “The panel’s Investigations and Oversight Subcommittee will hold a hearing next week to get an update on the 2015 Medicare Access and CHIP Reauthorization Act, which overhauled the formula used to pay doctors under Medicare, members confirmed.
  • “Doctors have complained that their Medicare payments are effectively being cut under the current system, fueling consolidation among doctors and hospitals.”
  • HR Dive informs us
    • Employers will have to wait at least a few more months for some long-awaited regulatory changes, the U.S. Department of Labor said Tuesday.
    • A proposal to increase the Fair Labor Standards Act’s overtime salary threshold previously expected in May has been pushed to August, DOL’s Wage and Hour Division indicated in its spring regulatory agenda.
    • A final rule expected from WHD, one that would likely tighten rules for classifying workers as independent contractors, was similarly delayed to August. Just days before the agency published its agenda, it also indicated in a court filing that it expects to have the independent contractor rule out soon — by October at the latest.

From the public health front –

  • Health Day points out
    • “Most women diagnosed with early breast cancer will become long-term survivors, according to new research that finds a substantial reduction in the risk of death since the 1990s.
    • “This news should reassure both patients and their doctors, researchers report June 13 in the BMJ.
    • “Our study is good news for the great majority of women diagnosed with early breast cancer today because their prognosis has improved so much,” said the authors, who included Dr. Carolyn Taylor, a professor of oncology at the University of Oxford in England. 
    • “Most of them can expect to become long-term cancer survivors,” they added in a journal news release.”
  • The National Institutes of Health announced
    • “Men were significantly more vulnerable than women to overdose deaths involving opioid and stimulant drugs in 2020-2021, according to a new study(link is external) analyzing death records data from across the United States. The study found that men had a 2–3 times greater rate of overdose mortality from opioids (like fentanyl and heroin) and psychostimulants (like methamphetamine and cocaine). While it has been known that men use drugs at higher rates than women, the researchers found that this alone does not explain the gap in overdose deaths, noting that biological, behavioral, and social factors likely combined to increase the mortality risk for men.
    • “The study, published in Neuropsychopharmacology, was led by investigators at the Icahn School of Medicine at Mount Sinai in New York City and the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health.
    • “Though men and women are being exposed to the modern, fentanyl-contaminated drug supply, something is leading men to die at significantly higher rates. It may be that men use drugs more frequently or in greater doses, which could increase their risk of death, or there may be protective factors among women that reduce their risk of death compared to men,” said Nora Volkow, M.D., director of NIDA and one of the co-authors on the study. “Understanding the biological, behavioral, and social factors that impact drug use and our bodies’ responses is critical to developing tailored tools to protect people from fatal overdose and other harms of drug use.”
  • NFC relates,
    • “Over the past 12 months, roughly half (45%) of American workers reported spending between $500 and $6,000 on mental health services, with nearly one-third (32%) saying they spent more than $1,501. This comes at a time when 95% of workers report they are concerned about the economic situation in the US, and financial worries are adding to their stress and burnout.
    • “Despite rising employee stress, fewer than 6% of employers say they spend more than $500 on mental health per employee, and 72% do not plan to add additional mental health support in the year ahead.
    • “These are among the findings from leading benefits consultant NFP’s 2023 US Benefits Trend Report.”
  • Bloomberg reports on chemotherapy drug shortages facing our country.

In conference news, AHIP reports on the final day of its conference while Healthcare Dive discusses the actions taken at the AMA House of Delegates meeting. Beckers Hospital Review reports on Kaiser Permanente CEO Greg Adams’ keynote speech at the AHIP conference.

From the U.S. healthcare business front —

  • Beckers Hospital Review tells us
    • “A data visualizer shows the ten most similar hospitals to any one benchmark hospital, challenging traditional, ordinal rank lists in a time of great volatility for hospitals. 
    • “SimilarityIndex | Hospitals comes from Trilliant Health, which created the tool so health economy stakeholders can learn how similar a selected benchmark hospital is to — or different from — highly regarded U.S. hospitals. 
    • “Becker’s took the ten top-ranked hospitals from the latest U.S. News and World Report’s Honor Roll to find their five most similar aggregate peers. Their similarity scores are listed [in the article].” 
  • BioPharma Dive reports
    • “Coherus BioSciences has batted back a legal challenge from AbbVie weeks before it plans to launch a much cheaper version of the latter company’s best-selling rheumatoid arthritis drug Humira.
    • “The latest dispute began after Coherus on June 1 announced plans to sell its biosimilar, dubbed Yusimry, at an 85% discount to Humira and work with Mark Cuban’s online pharmacy to provide it to other patients for even less starting in July. On June 6, Coherus received a notice from AbbVie saying that the plans violated a licensing agreement between the two companies.
    • “After a round of correspondence and dueling court filings, the companies resolved the dispute on Wednesday. AbbVie won’t terminate the license agreement based on its June 6 notice and agreed not to try to terminate the license in the future unless it both notifies Coherus of an alleged breach and also gives the company a chance to fix the problem, Coherus said in a regulatory filing.”
  • KFF reports
    • “A new report has provided the first national count of Americans who rely on health care sharing plans — arrangements through which people agree to pay one another’s medical bills — and the number is higher than previously realized.
    • “The report from the Colorado Division of Insurance found that more than 1.7 million Americans rely on sharing plans and that many of the plans require members to ask for charity care before submitting their bills.
    • “The total membership numbers are likely even higher. The state agency collected data from 16 sharing plans across the U.S. but identified five other plans that did not report their data.
    • “These plans cover more people than we had previously known,” said JoAnn Volk, co-director of the Center on Health Insurance Reforms at Georgetown University.
    • “Under the arrangements, members, who usually share some religious beliefs, agree to send money each month to cover other members’ health care bills. At least 11 of the sharing plans that reported data operated in or advertised plans in all 50 states in 2021.”
  • The Washington Post reports on consumer concerns about employer-sponsored and public health plans.
    • “By the numbers:
    • “About 26 percent said that a doctor covered by their insurance didn’t have any available appointments. One-third of Medicaid enrollees reported having such an issue.
    • “Roughly 18 percent of those surveyed indicated their insurance didn’t pay for care they thought was covered. That complaint was more common among those with employer-sponsored health insurance and Obamacare plans.
    • “Nearly 3 in 4 insured adults who have received mental health treatment in the past year report experiencing a problem with their insurance.” 

Happy Flag Day!

David Ermer–ACA, CMS, Congress, FDA, No Surprises Act, Rx coverage, U.S. Healthcare–
Thanks to Aaron Burden for sharing their work on Unsplash.

From Washington DC —

  • The Senate Finance Committee announced
    • “Senate Finance Chairman Ron Wyden (D-Ore.), Senate Finance Ranking Member Mike Crapo (R-Idaho) alongside U.S. Senators Bob Menendez (D-N.J.), Marsha Blackburn (R-Tenn.), Jon Tester (D-Mont.), Roger Marshall (R-Kan.), today introduced the Patients Before Middlemen (PBM) Act to delink the compensation of pharmacy benefit managers (PBMs) from drug price and utilization in order to better align incentives that will help lower prescription drugs costs for Medicare Part D beneficiaries.”
  • Fierce Healthcare informs us
    • “While national health spending growth slowed in 2022, that trend isn’t likely to stick around.
    • “Experts at the Centers for Medicare & Medicaid Services’ Office of the Actuary predict that health spending growth will outstrip growth in the economy over the next decade, according to a study published in Health Affairs. Between 2022 and 2031, the actuaries predict spending will increase by 5.4% on average each year, faster than the estimated annual gross domestic product growth of 4.6%.”
  • As the French say, Plus ça change, plus c’est la même chose (literally the more it changes, the more it’s the same thing”.
  • CMS made its No Surprises Act website more consumer friendly.

In conference news, MedPage Today fills us in on the American Medical Association conference and Smartbrief does the same for the AHIP conference.

From the Rx coverage front —

  • Beckers Hospital Review tells us,
    • “Mark Cuban Cost Plus Drug Co. considered selling insulin but found the price doubled with shipping costs, CEO and co-founder Alex Oshmyansky, MD, PhD, said June 13 at the AHIP conference. * * *
    • “We were working on bringing in an insulin product to the market for quite some time,” he said at the conference. “We did actually bring one to the market, we did it as sort of a closed beta pilot to see what consumer response would be. But ultimately, direct to consumer mail-order it was $35 for a month’s supply but $65 for the shipping and handling. It didn’t quite make sense within our model. We almost viewed it as a solved problem from the consumer perspective at this point. You know, almost everyone has access to $35 insulin in one form or another now.”
  • Reuters reports,
    • “Pfizer (PFE.N) has warned that a drug used to treat syphilis and other bacterial infections in children could run out by the end of June because it has had to prioritize versions made for adults due to a spike in syphilis infections in that population.
    • “Supply of the pediatric version of the drug, Bicillin L-A, is expected to be exhausted by the end of this quarter, the company said in a letter to the U.S. health regulator dated Monday. Pfizer said in an email on Tuesday that the pediatric formulations of the antibiotic are not widely used.”
  • Medscape informs us
    • The US Food and Drug Administration (FDA) has expanded the indication for linaclotide (Linzess) to children as young as age six years with functional constipation, making it the first approved treatment for pediatric functional constipation.
    • The recommended dosage in pediatric patients is 72 mcg orally once daily.
    • Functional constipation is common in children and adolescents. Symptoms include infrequent bowel movements with hard stools that can be difficult or painful to pass.
    • There is no known underlying organic cause, and there are typically multiple contributing factors, the FDA notes in a statement announcing the approval.

From the U.S. healthcare business front —

  • Healthcare Dive notes,
    • “Pent-up demand for delayed healthcare during the COVID-19 pandemic is pressuring medical costs for health insurers that had a financial windfall during the pandemic amid low utilization.
    • “UnitedHealth, the parent company of the largest private payer in the U.S., expects its medical loss ratio — the share of premiums spent on member’s healthcare costs — to be higher than previously expected in the second quarter of 2023, due to a surge in outpatient care utilization among seniors,” CFO John Rex said Tuesday during Goldman Sachs’ investor conference.”
  • Fierce Healthcare relates,
    • “Cerner brought in $1.5 billion in revenue in the latest quarter, boosting strong growth for enterprise software giant Oracle. The health IT company also generated $5.9 billion in revenue for Oracle’s 2023 fiscal year, which ended May 31.
    • “Oracle’s revenue reached an all-time high of $50 billion last year, driven by growing demand for its cloud offerings from companies deploying AI.”

In litigation news —

  • Health Payer Intelligence points out,
    • On June 13, “A federal appeals court approved an agreement between parties in Braidwood Management v Becerra, preserving the mandate requiring health plans to cover preventive care services based on recommendations from the US Preventive Services Task Force (USPSTF). * * *
    • “While the federal government works to appeal Judge O’Connor’s ruling, it cannot penalize Braidwood Management for refusing to cover USPSTF-recommended preventive care services. Additionally, if the court upholds the mandate in the appeal, the Biden administration cannot retroactively penalize the plaintiff.”

Tuesday Tidbits

David Ermer–Congress, COVID-19, COVID-19 vaccine, Medical / Rx research, Medicare, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC —

  • The House of Representatives Committee on Education and the Workforce held a hearing today to examine the policies and priorities of the Department of Health and Human Services.
  • STAT News adds
    • “A key House Republican ramped up his criticism of pharmacy benefit managers Tuesday, calling for the government to dismantle companies that have consolidated drug supply chain operations.
    • “We should break these PBMs up,” House Oversight Committee Chair James Comer (R-Ky.) said during an Education and Workforce Committee hearing. Health Secretary Xavier Becerra testified at the hearing on his department’s priorities. * * *
    • “Comer asked Becerra what the administration thinks should be done to reform PBMs.
    • “Transparency,” Becerra responded. “As they say, sunshine is the best disinfectant.”
  • STAT News reports from the Senate
    • “In another bid to lower prescription drug prices, U.S. Sen. Bernie Sanders (I-Vt.) issued a report showing that medicines developed with help from the National Institutes of Health have often cost Americans more than what is paid in other countries. And he called on the agency to reinstate a provision in federal law that would require companies to set reasonable prices when they license NIH inventions. * * *
    • “The report was issued as the Biden administration seeks confirmation of Monica Bertagnolli, who currently heads the National Cancer Institute and was nominated to run the NIH. But the confirmation cannot proceed without support from Sanders because, as chair of the Senate health committee, he controls when nominees are reviewed for positions in the Department of Health and Human Services.
    • “However, Sanders threatened that he will not proceed until the Biden administration provides a “comprehensive” plan to lower prescription drug prices. The White House reportedly responded by acknowledging that prescription drug costs remain high for many Americans and pointed to the Inflation Reduction Act, a recently enacted law that allows Medicare to negotiate prices for certain medicines.”
  • Fierce Healthcare reports
    • “The Biden administration is rolling out new flexibilities that aim to prevent procedural coverage losses as states work through a backlog of Medicaid eligibility determinations.
    • “The Department of Health and Human Services announced that managed care plans can take on a more direct role in assisting members in completing renewal forms. This extends to filling out certain parts of the paperwork on behalf of the member.
    • “In addition, states are able to delay administrative disenrollments by a month for further outreach, which will allow for greater time to fill out necessary forms and paperwork. The agency will also allow pharmacies and community-based organizations to assist in getting coverage reinstated for people who are still eligible but lost coverage for procedural reasons.
    • “Procedural disenrollment is a key concern during the Medicaid redetermination period, as many people who are at risk of losing coverage are not aware that the process is even going on. A recent analysis from KFF looking at early redetermination data found that in a number of states, large numbers of disenrollments are linked to administrative issues.”
  • and
    • “Industry hospital groups are pushing the Centers for Medicare & Medicaid Services (CMS) to consider a higher annual pay bump and to shed some light on why it believes the number of uninsured patients won’t be increasing during fiscal year 2024.
    • “In April, CMS released its proposed fiscal year 2024 Inpatient Prospective Payment Systems (IPPS) rule with a 2.8% increase in payments for the 12-month period beginning in October.
    • “The tentative pay raise for eligible participating hospitals translates to a collective $3.3 billion increase, CMS said at the time, and is based on a 3% projected hospital market basket update minus a 0.2 percentage point productivity adjustment.
    • “Comment letters submitted by the American Hospital Association (AHA) and other major hospital industry groups on Friday homed in on the 2.8% net update as “woefully inadequate” in light of cost pressures, such as inflation and labor spend, that have not subsided since the height of the COVID-19 pandemic.”

From the public health front —

  • The Wall Street Journal tells us
    • “Longevity researchers have spent decades hunting for a magic pill to slow the aging process. But the best solution—at least for now—may be the simplest one: Move more.
    • “No single thing—whether it’s regular cold plunges or off-label drugs and supplements like metformin, rapamycin or taurine—has a track record that can match exercise’s in terms of protecting against age-related diseases and helping people get more from their later years, a vast body of research shows.
    • “The muscle and bone growth stimulated by exercise can help older adults maintain their independence, lessen fatigue and protect against bad injuries from falls, the leading cause of injury-related death among those over 65. 
    • “Regular exercise can reduce the risk of developing certain age-related diseases, including Alzheimer’s, cancer, diabetes and cardiovascular disease. * * *
    • “Any amount of physical activity can help extend a person’s life, research suggests, especially for people who currently are doing very little. Federal guidelines recommend that adults get at least 150 minutes of moderate-intensity exercise a week. 
    • “A team of researchers who analyzed data on more than 650,000 adults over about a decade found that, compared with those who were inactive, those who got about half the government’s recommended physical activity added an average of 1.8 years to their lives. Those who exercised for roughly five to eight hours weekly gained an average of 4.2 years.
    • “When you think about that, in terms of how many years you’re gaining per how many minutes of activity, it’s a very sizable yield,” says Steven C. Moore, the study’s lead author and senior investigator at the National Cancer Institute.”
  • Healthcare Dive informs us
    • “Uber will soon be able to deliver groceries and other over-the-counter items to patients of its payer and provider clients, in the latest benefits expansion of its Uber Health platform.
    • “Uber Health, which already provides non-emergency medical transportation and prescription delivery, has been expanding beyond medical transportation to care coordination across multiple benefits, Catilin Donovan, the head of the division, said in an interview. Soon, provider users will have access to patient benefit data and eligibility files from their health insurers, so they can prescribe services they know are covered.
    • Uber is not yet giving specifics of Uber Health’s financial performance, but Uber Health grew bookings by 75% year over year in the first quarter. Donovan declined to say whether Uber Health was profitable.”
  • The Government Accountability Office released a watchdog report on law enforcement-oriented approaches to reducing deaths from drunk driving.
  • The All of Us campaign issued its June report.

From the medical research front,

  • The National Institutes of Health announced
    • “Repeat treatment with corticosteroid injections improved vision in people with persistent or recurrent uveitis-related macular edema better than two other therapies, according to results from a clinical trial funded by the National Eye Institute (NEI). Compared with methotrexate or ranibizumab intravitreal (in-the-eye) injections, the corticosteroid treatment achieved greater reductions in retinal swelling and was the only therapy in the study that improved vision. The report was published today in the journal Ophthalmology. NEI is part of the National Institutes of Health.”
  • The Cigna Newsroom relates,
    • “A new study by Cigna Healthcare found that site-of-care redirection is associated with favorable clinical outcomes and increased access and affordability for peg­filgrastim, an injection used to prevent infection in cancer patients. The results showed that patients experienced better outcomes when the injection was administered in a home setting rather than a nonhome setting. The study was recently published in the Journal of Clinical Pathways.
    • “This study shows that we can help improve health outcomes by providing cancer patients with treatment such as infusions in a setting where many are most comfortable – home,” said Dr. Scott Josephs, chief medical officer, Cigna Healthcare. “These findings confirm that home infusion of complex and expensive specialty medications presents new opportunities to maximize access, improve effectiveness, increase affordability, and enhance convenience for patients.”

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.

Weekend update

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

From Washington, DC —

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

Fortune Well offers us advice on the following topics:

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

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

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

Thursday Miscellany

David Ermer–CMS, Congress, COVID-19 vaccine, FDA, HSA, Medical / Rx research, Medicare, Rx coverage, Telehealth–
Photo by Josh Mills on Unsplash

From Washington, DC —

  • The Senate Finance Committee held a hearing today about “Consolidation and Corporate Ownership in Health Care: Trends and Impacts on Access, Quality, and Costs.”
  • Mercer Consulting informs us
    • “Two key House committees voted this week to send a series of health care bills to the House floor, including legislation to make permanent the ability of health savings account-qualifying high-deductible health plans (HSA-qualifying HDHPs) to cover telehealth and other remote care services on a predeductible basis. Originally enacted as part of the 2020 Coronavirus Aid, Relief and Economic Security (CARES) Act, this flexibility was most recently extended as part of the 2023 Consolidated Appropriations Act, and now is set to expire on Dec. 31, 2024, for calendar-year plans (later for noncalendar-year plans).”
  • “The U.S. Department of Health and Human Services (HHS) released the STI Federal Implementation Plan to detail how various agencies and departments across the federal government are taking a comprehensive approach to making meaningful and substantive progress in improving public health. This new plan builds on other key HHS actions to protect the public’s health by addressing the growing threat of sexually transmitted infections (STIs) in America.”
    • Roll Call identifies potential obstacles to implementing this plan.
  • Govexec reports
    • “As smoke from Canadian wildfires moves into the Northeast and Mid-Atlantic regions of the United States, triggering air quality warnings in several cities, the Office of Personnel Management on Thursday reminded agencies to protect the health of federal workers who ordinarily may work or commute to work amid the hazardous haze.”
      • Healthcare Dive discusses health system reactions to this problem.
        • “Hospitals in the northeastern U.S. are keeping an eye on air quality as smoke from Canadian wildfires envelops the region. Most health systems contacted by Healthcare Dive did not report significant spikes in patient volumes yet, but they said they’re continuing to monitor the situation.
        • “Millions of people live in areas currently under air quality alerts, and meteorologists say conditions may not significantly improve for a few more days.
        • “Health systems in the region are urging residents to stay indoors and use masks — particularly snug-fitting N95s — when traveling outside. Though everyone should limit their time outdoors, it’s especially important for older people, children and pregnant women as well as those with conditions like heart or lung disease or asthma, according to Kristin Fless, a pulmonologist at RWJBarnabas Health Medical Group.”
  • The Wall Street Journal relates
    • “Ashish Jha, the White House Covid-19 czar, will be leaving his post next week in the latest sign the Biden administration is confident the country is on stronger footing in its fight against the virus.
    • “Jha plans to leave June 15 and return July 1 to his previous position as dean of Brown University’s School of Public Health. He will be the last of the administration’s rotating Covid-19 czars. Instead, the director of the White House’s nascent Office of Pandemic Preparedness and Response Policy, who hasn’t been named, will advise the president and coordinate federal responses to various biological and pandemic threats.”

From the  public health front —

  • Mercer Consulting tells us
    • Our research over the past few years has tracked the ways employers are working to align employee benefit programs with their organizations’ overarching DEI goals. For Pride month, here’s a round-up of survey results relating to health and well-being benefits of particular importance to the LGBTQ+ community.
    • Here’s a link to the article.
  • The American Hospital Association reports
    • “The first data on the safety of a third mRNA COVID-19 vaccine dose among young children show that a third dose is safe for children ages 6 months to 5 years old, similar to findings for doses one and two, the Centers for Disease Control and Prevention reportedtoday, based on reports to the Vaccine Adverse Event Reporting System and v-safe voluntary smartphone health checker for use after vaccination.
    • “This study’s findings can reassure health care professionals, parents, and caregivers that a third dose of COVID-19 vaccine is safe for children ages 6 months to 5 years and can protect them from severe illness,” CDC said.
    • “While CDC recommends that all children ages 6 months through 5 years old receive at least 1 bivalent mRNA COVID-19 vaccine dose, vaccination rates among this age group have been low.”
  • Health Payer Intelligence informs us
    • “Group health insurance plan members with high healthcare spending often have one or more of the same five chronic diseases, according to a fast facts sheet from the EBRI Center for Research on Health Benefits Innovation (EBRI CRHBI).
    • “The study covered healthcare claims from 8.6 million group insurance health plan members using 2021 data from the Merative MarketScan Commercial Database. Members were 65 years of age or younger and the health plans covered a variety of types.
    • “Five conditions were very common among the group health insurance plan members with the highest healthcare spending: heart disease, respiratory conditions, musculoskeletal conditions, nervous system conditions, and skin disorders. A couple of these are among the most expensive chronic diseases in the US. They are also some of the most common comorbidities.”

From the Rx coverage front —

  • BioPharma Dive notes that tomorrow a Food and Drug Administration advisory committee will consider recommending that the FDA give full marketing approval to the Alzheimer’s drug Leqembi.
    • “A closely watched Alzheimer’s disease medicine appears to be heading toward broader approval, as documents released Wednesday show the Food and Drug Administration appears to have few concerns with it.”
  • BioPharm Dive also tells us that “After years of disappointment, cancer vaccines show new promise. Moderna presented new data at ASCO for its melanoma shot, highlighting progress with a personalized approach that’s also being pursued by BioNTech and Gritstone.”
    • “Moderna is testing its shot, mRNA-4157, together with Merck’s immunotherapy Keytruda in people with melanoma who have had their primary tumors removed. The goal of such “adjuvant” treatment is to prevent cancer from returning.
    • “In December, the company reported the two drugs reduced the relative risk of death or recurrence by 44% over Keytruda alone. The new data came from an analysis of the risk of cancer spreading to distant organs or tissues, or “distant metastasis free survival.”
    • “One-third of patients who receive Keytruda in this setting experience such spread, driving researchers’ work to come up with better options. “We know that patients with distant metastases experience more morbidity and mortality,” said Adnan Khattak, a clinical professor at Edith Cowan University in Australia, who presented the Moderna data at ASCO.
    • “In the combination trial, mRNA-4157 and Keytruda reduced the risk of distant spread or death by 65% compared to Keytruda alone.”
  • The Associated Press reports
    • “A growing shortage of common cancer treatments is forcing doctors to switch medications and delaying some care, prominent U.S. cancer centers say.
    • “The National Comprehensive Cancer Network said Wednesday that nearly all the centers it surveyed late last month were dealing with shortages of carboplatin and cisplatin, a pair of drugs used to treat a range of cancers. Some are no longer able to treat patients receiving carboplatin at the intended dose or schedule. 
    • “Dr. Kari Wisinski has had to turn to other treatments for some patients or switch the order in which people receive their drug combinations. She said she’s done that “hoping that within three months there will be a better carboplatin supply.” * * *
    • “The U.S. Food and Drug Administration has taken some steps to try to ease the chemotherapy shortage. The agency is allowing the temporary importation of some foreign-approved versions of cisplatin from factories registered with the FDA.”
  • Beckers Hospital Review adds “Seventy percent of the 20 most commonly prescribed medications from GoodRx are in shortage, according to databases from the FDA and the American Society of Health-System Pharmacists.” The article goes on to list the drugs subject to shortages.

From the Medicare front —

  • Beckers Payer Issues informs us
    • “The FDA and CMS are discussing how to handle obesity drugs in Medicare, Bloomberg Law reported June 7. 
    • “The two agencies are in talks over “what to do about obesity drugs,” FDA Commissioner Robert Califf said at the Biotechnology Innovation Organization convention in Boston. Mr. Califf’s comments indicate CMS could expand weight loss benefits, according to Bloomberg Law’s report. 
    • “New GLP-1 drugs to treat obesity and diabetes can be expensive, costing upward of $10,000 a year without insurance coverage. GLP-1 drugs, including Ozempic, Trulicity, Victoza and Mounjaro, are used to treat Type 2 diabetes. Wegovy and Saxenda are approved for weight loss.  
    • “Under current law, Medicare is prohibited from covering weight loss drugs. Drug manufacturers are lobbying Congress to require the program to pay for the drugs. Proposed legislation to pay for the drugs has stalled. 
    • “The drugs could have a big effect on Medicare Part D spending. If 10 percent of people with obesity covered by Medicare were prescribed a brand-name semaglutide, a type of GLP-1, the drug would cost Medicare $26.8 billion annually, according to a study published in the New England Journal of Medicine in March.”
  • and
    • “Medicare spending per person grew by an average of 4.6 percent annually between 2000 and 2022, according to a June 6 analysis from KFF. 
    • “KFF analyzed data from the 2023 Annual Report of the Boards of Trustees of the Federal Hospital Insurance and Federal Supplementary Medical Insurance Trust Funds. 
    • “KFF said the “influx of the Baby Boomer Generation added many relatively younger, healthier people to the Medicare beginning in 2011,” while the share of adults aged 80 and older enrolled in the program also continues to grow. Growth in healthcare spending is attributed to this increased volume and use of services, along with the availability of new technologies and rising prices.”
      • 2018: $13,579
      • 2019: $14,189
      • 2020: $14,373
      • 2021: $15,139
      • 2022: $15,727