FEHBlog

A Busy Thursday

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • STAT News tells us,
    • “A House committee overwhelmingly passed four bills on Thursday that would expand Medicare coverage of obesity drugs and cancer screening blood tests and place guardrails around Medicare’s discretion in covering drugs and devices approved by the Food and Drug Administration.
    • “[By a 36-4 bipartisan vote],the House Ways & Means Committee passed obesity drug coverage legislation that would offer a limited pathway for adults 65 and older to get their weight loss drugs paid for by Medicare. Right now, Medicare is prohibited from covering medications used for weight loss, like Wegovy and Zepbound. 
    • “However, the new plan is significantly more restrictive than prior proposals. It’s primarily targeted at making sure that people currently taking weight loss drugs don’t get kicked off when they enter the Medicare program, such as by turning 65.” * * *
    • “Another bill that gained even more support would expand Medicare coverage of cancer screening. The legislation passed on a 38-0 vote. 
    • “Medicare is allowed to pay for FDA-approved tests that diagnose diseases, but it doesn’t cover tests that simply screen healthy people for cancer. The bill would open the door for Medicare to pay for cancer screening tests, including Grail’s Galleri.” 
  • MedPage Today informs us,
    • “Value-based care — in which medical practices are paid based on the value of their care, not on volume — is a good idea but the Centers for Medicare & Medicaid Services (CMS) need to improve its implementation, doctors and a healthcare executive told members of the House Ways & Means Health Subcommittee.
    • “I am a proponent of the need to move to value-based care, improving quality while decreasing wasteful spending and ensuring access,” Robert Berenson, MD, an institute fellow at the Urban Institute in Washington, D.C., said at Wednesday’s subcommittee hearing on improving value-based care for patients and providers. “However, I believe that value-based payment as a mechanism to promote better care delivery has gotten off track and needs a thorough reevaluation and reformulation.”
  • Fierce Pharma relates,
    • “Leading health legislators say they are focused on reducing prescription drug prices while minimizing unintended consequences of the Inflation Reduction Act (IRA).
    • “House Rep. Scott Peters, D-California, and Rep. Mariannette Miller-Meeks, R-Iowa, shared their priorities during a program put on by The Hill and the Alliance for Aging Research.
    • “Peters stressed that the drug manufacturing industry needs to stay in the U.S., unlike how the country let chip manufacturing business slip away and go offshore. He also wants lawmakers to budget healthcare expenditures differently.
    • “Innovation might cost more money upfront, even if it saves money down the line,” he said. “In the Budget Committee, which I also serve on, we’re talking about how to think about balancing the budget over time. If we don’t think about the future costs of all these diseases, as part of that calculation, I think we’re going to miss the mark.”
  • Per CMS fact sheets,
    • On June 26, 2024, the Centers for Medicare & Medicaid Services (CMS) issued the Calendar Year (CY) 2025 Home Health Prospective Payment System (HH PPS) proposed rule, which would update Medicare payment policies and rates for Home Health Agencies (HHAs). These changes can support timely admission to home health services, which has demonstrated improvements for patient outcomes and reducing risk of hospital readmissions. 
  • and
    • “On June 27, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to update payment rates and policies and includes requests for information under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for renal dialysis services furnished to Medicare beneficiaries on or after January 1, 2025.
    • “For CY 2025, CMS is proposing to increase the ESRD PPS base rate to $273.20, which would increase total payments to all ESRD facilities, both freestanding and hospital-based, by approximately 2.2%.”
  • HHS’s Office for Civil Rights announced,
    • “At the HHS Office for Civil Rights, we believe patient privacy is essential to ensuring high quality reproductive health care. HHS OCR is encouraging HIPAA covered entities and business associates to begin implementing the new HIPAA Privacy Rule to Support Reproductive Health Care Privacy to help protect patient privacy and ensure compliance later this year. To aid in this, we have compiled resources for both community members and HIPAA Covered Entities or Business Associates. 
      • “For resources to help communicate with stakeholders and community members click here.
      • “For a fact sheet summary of the rule click here (en español).
      • “To hear directly about the rule from Director Melanie Fontes Rainer click here (en español).
      • “To view a recorded briefing by Deputy Director for Health Information Privacy, Data and Cybersecurity Timothy Noonan click here.
      • “For a model attestation for a requested use or disclosure of protected health information potentially related to reproductive health care click here.
    • “The effective date of the Final Rule was June 25, 2024. This is the date that HIPAA covered entities and their business associates may begin implementing the new requirements. Covered entities and business associates are not required to comply with the new requirements until December 23, 2024, except for the new changes to the HIPAA Notice of Privacy Practices which has a compliance date of by February 16, 2026.”
  • Healthcare Dive lets us know,
    • “The U.S. Supreme Court ruled 6-3 on Thursday to allow Idaho doctors to perform abortions to stabilize a patient’s life and health. 
    • “However, the court declined to take up the fundamental legal question underlying the case: whether a federal law mandating hospitals provide medical services during emergencies [known as EMTALA] supersedes near-total state abortion bans.
    • “It is the court’s first ruling on statewide abortion restrictions since Roe v. Wade was overturned in 2022, ending the constitutional right to abortion in the United States.”
  • CMS observed,
    • “CMS’ first responsibility is to the people we serve, including anyone who steps into the emergency department of a Medicare-participating hospital. If any individual believes their EMTALA rights have been violated, they should continue to report the circumstances to CMS or their state survey agency. To the maximum extent permitted by law, we will continue to investigate complaints and hold hospitals accountable to provide the emergency stabilizing treatment that EMTALA has required for decades.”
  • The Wall Street Journal reports,
    • “The Supreme Court rejected a bankruptcy plan for OxyContin-maker Purdue Pharma that would have allocated billions of dollars from members of the wealthy Sackler family to combat opioid addiction in exchange for shielding them from civil lawsuits over their alleged role in fueling the drug epidemic.
    • “The 5-4 decision marks a victory for the minority of opioid victims who voted to reject the settlement plan because they want to continue pressing lawsuits against the Sackler family members who own Purdue, and a loss for the majority of opioid victims and state and local governments who voted to accept it.”
    • “The high court said U.S. bankruptcy law doesn’t allow for a release of the Sacklers’ legal liabilities stemming from their ownership of Purdue when not all opioid-related plaintiffs have accepted the terms offered by the company’s family owners, whose wealth has been estimated at $11 billion.” * * *
    • “Thursday’s ruling—among the highest-profile bankruptcy decisions ever from the high court—weakens the ability of corporations and their insiders to use bankruptcy to resolve mass litigation alleging they harmed consumers. 
    • “The Sacklers didn’t file for bankruptcy themselves and didn’t agree to place “anything approaching their full assets on the table” for distribution to opioid victims, [Justice Gorsuch] wrote [for the Court’s majority]. “Yet they seek a judicial order that would extinguish virtually all claims against them for fraud, willful injury, and even wrongful death, all without the consent of those who have brought and seek to bring such claims,” he wrote. 
    • “Nothing in U.S. bankruptcy law authorizes that outcome, [Justice] Gorsuch said.
  • Fierce Pharma adds,
    • “The Supreme Court decision sends the case back to bankruptcy court for future deliberations, according to a statement from Connecticut Attorney General William Tong.”

From the public health and medical research front,

  • The New York Times reports,
    • “All Americans ages 6 months and older should receive one of the new Covid-19 vaccines when they become available this fall, the Centers for Disease Control and Prevention said on Thursday.
    • “The recommendation comes as the nation faces a summer wave of Covid, with the number of infections rising in at least 39 states and territories.
    • “Most Americans have acquired immunity against the coronavirus from repeat infections or vaccine doses, or both. The vaccines now offer an incremental boost, remaining effective for only a few months as immunity wanes and the virus continues to evolve.
    • “Still, across every age group, a vast majority of Americans who were hospitalized for Covid did not receive one of the shots offered last fall, according to data presented at a meeting on Thursday of the C.D.C.’s Advisory Committee on Immunization Practices.
    • “Dr. Mandy Cohen, the agency’s director, accepted the unanimous advice of the panel on Thursday to recommend another round of immunizations.”
  • The NIH Director writes in her blog,
    • “Cancer arises when changes in genes that normally control cell division lead to unchecked growth at the expense of healthy tissues. One of the most common genetic alterations across human cancers—occurring in 95% of pancreatic cancers but also many non-small cell lung cancers, colorectal cancers, and others—is in a gene known as KRAS. While promising new treatments targeting KRAS to shrink cancerous tumors have recently gained approval, less than 40% of pancreatic cancers respond to treatment with KRAS inhibitors for reasons that aren’t well understood.
    • “There’s much more to learn about how KRAS spurs cancer growth—and how KRAS-mutant cancers resist treatment with existing KRAS inhibitors. To address this need, researchers behind two studies in Science have established the most comprehensive molecular portrait yet of the workings of KRAS and how its many downstream impacts may influence outcomes for people with pancreatic cancer. The findings could lead to new treatment approaches, including ways to potentially guide treatment for individuals with pancreatic cancer, the third leading cause of cancer-related death in the U.S.
    • “These studies, supported in part by NIH, come from a team led by Channing Der  and Adrienne Cox, together with Jeffrey Klomp, Clint Stalnecker, and Jennifer Klomp, at the Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill. The researchers were inspired in part by the Food and Drug Administration’s recent approval of treatments that block a mutated version of KRAS that drives many pancreatic cancers. The team was also motivated by the realization that many patients whose cancers initially respond to the new treatments relapse rather quickly as the cancers find ways to reactivate underlying growth pathways.” * * *
    • “Importantly, the researchers found that the molecular signatures they’ve uncovered may predict tumor responses in patients treated with KRAS inhibitors or ERK inhibitors. Based on their findings, they suspect that the reason so many pancreatic cancers don’t respond to KRAS inhibitors may be because the drugs simply don’t block KRAS well enough—and not because the cancers no longer depend on KRAS signals for their growth. The researchers suggest it may be beneficial to monitor these underlying molecular pathways in patients to better understand treatment outcomes and guide treatment decisions.
    • “The team plans to continue exploring the role of these and other important drivers of cancer growth and treatment resistance. Ultimately, their goal is to help advance the development of the next generation of KRAS inhibitors that will work even better for many more people with pancreatic or other KRAS-driven cancers.”
  • Health Day notes,
    • “A full third of American adults take multivitamins, despite prior studies suggesting they do little to boost health.
    • “Now, a study involving almost 400,000 people finds zero benefit from multivitamin use in helping folks live longer.
    • “Among people “without a history of major chronic diseases, we did not find evidence to support improved longevity among healthy adults who regularly take multivitamins,” concluded a team led by Erikka Loftfield. She’s with the Division of Cancer Epidemiology and Genetics at the U.S. National Cancer Institute (NCI).
    • “Her team published its findings June 26 in the journal JAMA Network Open.
  • Healio calls to our attention a study finding
    • “Alcohol intake of more than 12 g per day was associated with increased risk for hypertension.
    • “Hypertension risk plateaued at higher levels of alcohol intake for men, but risk continued to rise for women.”
  • STAT News offers a detailed article titled “By the numbers: America’s alcohol-related health problems are rising fast.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Walgreens is pulling back its focus on healthcare services after the strategic shift failed to bolster the struggling retailer’s financial health.
    • “Walgreens plans to reduce its stake in value-based medical chain VillageMD, and will no longer be the company’s majority owner, CEO Tim Wentworth told investors on a Thursday morning call after announcing third quarter earnings below analyst expectations.
    • “Walgreens also plans to close a “significant portion” of its roughly 8,700 stores in the U.S., Wentworth said. The company didn’t share a specific figure, but said it is reviewing one-quarter of its stores that are underperforming financially. Walgreens has already closed hundreds of stores over the past few years.” * * *
    • “Walgreens plans to launch a retail pharmacy action plan to improve customer experience in its stores, better align its pharmacy and healthcare businesses and focus on reliable products in areas like women’s health, Wentworth said.
    • “The company is also in discussions with health insurers and pharmacy benefit managers to change how its pharmacies are paid, to create more stability in a challenging reimbursement environment.”
  • Modern Healthcare reports,
    • “At-home emergency care is gaining momentum — and could cost millions less — but reimbursement challenges create an access barrier for some patients.
    • “Deploying healthcare in patients’ homes gained traction during the COVID-19 pandemic as a way to ease overcrowding at hospitals and prevent the virus from spreading. Emergency department care at home lets patients bypass the waiting room through referrals from hospitals or primary care providers if they determine patients do not have life-threatening illnesses or injuries. While many private insurers reimburse for such care, traditional fee-for-service Medicare and Medicaid do not pay for it as a stand-alone service.
    • “Emergency department-at-home programs deploy paramedics or nurses to check vital signs, draw blood and take x-rays with portable imaging devices. Physicians supervise the visits via telehealth, then refer patients to primary care providers for further treatment or to hospital emergency departments if more complex care is needed.
    • “Healthcare technology company Medically Home and primary care provider Atrius Health, a division of UnitedHealth Group’s Optum Health, offer emergency department-care-at-home through a partnership in the Boston area. A study they published last week in the New England Journal of Medicine found more than 83% of 3,668 patients who received emergency care at home over two years did not require a trip to the hospital, saving Atrius approximately $4.5 million.
    • “Medically Home launched its service in 2020 and has served approximately 7,000 patients through contracts with three provider groups, including Atrius. The primary care provider has value-based care contracts with most of its patients and takes on the full risk for their care.”
  • FEHBlog observation: Intriguing!
  • Per Fierce Healthcare,
    • “Nineteen rural Minnesota hospitals and their 50-plus clinics have banded together to form a clinically integrated network (CIN) serving more than 750,000 people.
    • “The so-called Headwaters High-Value Network, announced Thursday, stitches the independent hospitals’ services together so that Minnesotans can coordinate their care across care sites. Together, the member groups employ about 9,000 people and bring in $1.3 billion of annual net revenue.
    • “Members of the network also said the approach will help their hospitals control rising care costs through reduced administrative burden and shared services. The CIN said it is “in discussions” with other interested rural Minnesota hospitals and “expects to grow.”
  • Beckers Hospital Review identifies the ten best states for hospital experience. Nevada leads the pack.
  • Beckers Hospital Review adds,
    • “Mark Cuban Cost Plus Drug Co. will serve as a wholesale drug distributor for all 71 hospitals affiliated with Community Health Systems, the organizations announced June 27. 
    • ‘Cost Plus Drugs launched the wholesale services in early 2024, but for the first time, the company is rolling out the offering to a large health system.
    • “The pharmaceutical company has direct relationships with 38 of the 40 largest generic manufacturers and multiple secondary distributors, according to Cost Plus Drugs’ CEO and co-founder, Alex Oshmyansky, MD, PhD.

Midweek Update

David Ermer–ACA, Congress, FDA, Federal employment benefits, Medical / Rx research, SDOH, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • Beckers Payer Issues reports,
    • “Making expanded ACA subsidies permanent would add $335 billion to the national deficit between 2025 and 2034, the Congressional Budget Office estimated. 
    • “Premium tax credits have spurred record enrollment in ACA marketplace plans. These subsidies, implemented in 2021, are set to expire at the end of 2025 unless Congress votes to extend them. 
    • “In a June 24 letter to the chairs of the House ways and means and budget committees, the CBO estimated making subsidies permanent would cost $415 billion overall — the result of a $250 billion increase in spending and a $164 billion decrease in tax revenue. 
    • “These costs would partially be offset by a decline in offers of employment-based insurance, the CBO estimated, resulting in a total add of $335 billion to the budget.  * * *
    • “Payer executives have told investors they are optimistic Congress will cut a deal to extend the subsidies or make them permanent.”
  • Fierce Healthcare tells us,
    • “A leading Democrat and health legislator is urging the Centers for Medicare & Medicaid Services (CMS) to better enforce Medicare Part D program requirements for pharmacy benefit managers.
    • “By evading such requirements, PBMs are threatening the financial health of the country’s smaller pharmacies, Senate Finance Committee Chair Ron Wyden, D-Oregon, wrote to the agency in a letter (PDF).
    • “I am alarmed to hear reports that PBM contracting practices are straining the finances of pharmacies and directly contributing to their closures,” he said. “Specifically, I am concerned PBMs are not adhering to the new rule reining in direct and indirect remuneration (DIR) fees that took effect on January 1 and undermining Medicare’s pharmacy access standards as intended by Congress.”
  • The National Academies of Sciences, Engineering, and Medicine released a report titled “Ending Unequal Treatment: Strategies to Achieve Equitable Health Care and Optimal Health for All” which follows up on a well-known 2003 report on social determinants of health.
  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration issued a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” to assist medical product sponsors in submitting Diversity Action Plans to support certain clinical studies. Diversity Action Plans are intended to increase clinical study enrollment of participants of historically underrepresented populations to help improve the data the agency receives about the patients who may potentially use the medical product. * * *
    • “Comments on the draft guidance should be submitted within 90 days after publication in the Federal Register to Regulations.gov. All written comments should be identified with the docket number and with the title of the guidance document.”
  • Federal News Network informs us,
    • “For more than a week, federal employees enrolled in FSAFEDS have not been receiving payments for approved reimbursement claims made in their Flexible Spending Accounts.
    • “The program suspended all reimbursement payments beginning June 16 as an effort to further strengthen anti-fraud and security measures, Federal News Network confirmed with a government source who explained the issue on the condition of anonymity.
    • “At this time, the FSAFEDS is holding all claims payments out of an abundance of caution,” FSAFEDS wrote Tuesday in a post on X. “FSAFEDS has taken this action due to recently discovered fraudulent claims activity. We are working to resolve and restore all claims payment activities as soon as possible.”
    • “The pause on reimbursement payments, however, has been lifted and payments to employees should resume soon, Federal News Network has learned. FSAFEDS plans to process all reimbursements currently on hold by the end of the week.

From the public health and medical research front,

  • MedPage Today tells us,
    • “All adults ages 75 years and older should receive a single dose of any respiratory syncytial virus (RSV) vaccine, and adults ages 60 to 74 years who are at increased risk of severe RSV disease should receive a vaccine, according to a unanimous 11-0 vote by the CDC’s Advisory Committee on Immunization Practices (ACIP).
    • “Also, people who have already received the RSV vaccine are not recommended to receive a booster, based on data that showed another dose did not improve outcomes.
    • “These recommendations supplant the current recommendation that adults ages 60 and older may receive RSV vaccination after engaging in shared clinical decision-making with their healthcare provider.
    • “There are currently three RSV vaccines available for use in older adults — GSK’s adjuvanted RSV prefusion F protein-based vaccine (Arexvy) Pfizer’s unadjuvanted, bivalent RSV prefusion F protein vaccine (Abrysvo), and Moderna’s mRNA-1345 vaccine (mRESVIA).
  • The American Hospital Association News notes,
    • “The Administration for Strategic Preparedness and Response June 25 announced a flu pandemic preparedness and response strategy in response to the threat of H5N1 bird flu in humans. The strategy, released through ASPR’s Biomedical Advanced Research and Development Authority, has four objectives: strategic implementation and deployment of the national pre-pandemic influenza vaccine stockpile; enhanced protection through novel vaccines; leverage therapeutics through deployment, early availability and development of novel products; and ensure rapid and effective diagnostics tools to inform rapid antiviral prescription and treatment.” 
  • BioPharma Dive calls attention to the fact “Women with a common hormonal disorder have few good treatment options. Could GLP-1 drugs help? There are no drugs specifically for polycystic ovary syndrome, a chronic condition that can cause infertility. One study is testing whether Wegovy might be beneficial.”
  • Per Fierce Pharma,
    • “[Verona Pharma’s] Ohtuvayre [which the FDA approved for marketing today] becomes the first novel treatment advance in more than a decade for COPD, an inflammatory condition which restricts airflow from the lungs and leaves patients struggling to breathe. Ohtuvayre is approved as an add-on medicine with current therapies.
    • “As a selective dual inhibitor of the phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) enzymes, Ohtuvayre combines two properties in one medicine, setting it apart in COPD for its ability to both open the airways of patients and reduce their inflammation.
    • “It’s really the first novel mechanism as an inhaled therapy in over 20 years for COPD,” David Zaccardelli, Verona’s CEO said in an interview with Fierce Pharma. “We believe its bronchodilator and non-steroidal anti-inflammatory activity has the potential to change the treatment paradigm.”
  • The Washington Post reports,
    • “A few of your favorite ice cream products might no longer be in the freezer this summer after a prominent supplier to brands such as Hershey’s and Friendly’s issued a recall notice over a potential listeria contamination.
    • “Maryland-based Totally Cool recalled products from 13 brands distributed nationwide in retail locations and through direct delivery after sampling by the Food and Drug Administration discovered the presence of Listeria monocytogenes, the bacterium that causes listeria infections, the agency said Monday.
    • “The brands involved were Abilyn’s Frozen Bakery, Amafruits, Chipwich, Cumberland Farms, Dolcezza Gelato, Friendly’s, Hershey’s Ice Cream, Jeni’s, LaSalle, Marco, Taharka Brothers, the Frozen Farmer and Yelloh. More than 65 products were recalled, including ice cream cakes and sandwiches, as well as sorbets, according to a list published by the FDA that includes expiration dates.”

From the U.S. healthcare business front,

  • Kaufmann Hall discusses the state of play in healthcare antitrust enforcement.
  • The Wall Street Journal predicts “The War Over Cheaper Ozempic Won’t End Well for Some Investors. Once Eli Lilly and Novo Nordisk increase supply of weight-loss medications, companies such as Hims & Hers may find it trickier to sell compounded versions of the drugs [due to the nuances of FDA law.]”
  • MedTech Dive points out “Abbott and Dexcom are launching the first over-the-counter CGMs. Here are 7 questions on the new tech. Experts expect the release of new over-the-counter glucose monitors in the U.S. to fuel more widespread use of the devices.”
  • Per Fierce Healthcare,
    • “Blue Shield of California is making it easier for members to access their personal health data through its new Member Health Record.
    • “The platform will combine health data both from claims as well as from providers in one place and is available both online and through Blue Shield’s app so members can connect virtually. The Member Health Record will first launch for a “select group” of Medicare Advantage members and will be rolled out to all of its members by the end of the year.
    • “The health record will include information on lab results, immunizations, diagnoses and conditions alongside historical health data that have been shared with the plan, including details tallied before the member joined Blue Shield.”

Tuesday Tidbits

David Ermer–AHRQ, CDC, Federal employment benefits, Medical / Rx research, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • KFF Health News reports,
    • “U.S. Surgeon General Vivek Murthy declared firearm violence a public health crisis, as gun deaths and injuries punctuate daily life in America.
    • “On nearly every day of 2024 so far, a burst of gunfire has hit at least four people somewhere in the country. Some days, communities have endured four or five such shootings.
    • “The nation’s top doctor called on policymakers to consider gun safety measures such as bans on assault weapons and high-capacity ammunition magazines and universal background checks for all firearm purchases. His advisory also urges a “significant increase” in funding for research on gun injuries and deaths, as well as greater access to mental health care and trauma-informed resources for people who have experienced firearm violence.”
  • NPR discusses what the declaration will do.
  • The U.S. Public Health Service Task Force issued a draft recommendation today which “concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for food insecurity on health outcomes in the primary care setting.” The public comment period ends on July 22, 2024.
  • Reg Jones, writing in FedWeek, explains “Earning, Accumulating and Using Sick Leave in the Federal Government.”

From the public health and medical research front,

  • The Washington Post reports,
    • “The Centers for Disease Control and Prevention warned clinicians, health authorities and the public Tuesday about an increased risk for dengue virus infections in the United States because of the record-breaking global incidence of the mosquito-borne viral disease.
    • “In the first six months of 2024, countries in the Americas have reported more than 9.7 million dengue cases, twice as many as in all of 2023, exceeding the highest number ever recorded in a single year, the CDC said in a health advisory. Puerto Rico declared a public health emergency because of the unusually high number of cases reported in the winter and spring, the dry season, when dengue cases are typically low.
    • “Since January, 745 dengue cases have been identified among U.S. travelers who became infected abroad, the agency said. Dengue cases typically increase during the warmest months that are yet to come. Last year, there were 1,829 travel-associated cases in the U.S. * * *
    • “With increased global and domestic incidence of dengue, the CDC is urging health-care providers to be on the lookout for dengue among people with fever who have been in areas with dengue transmission within 14 days of the start of illness. Infants, pregnant people, adults over 65 years old and people with certain medical conditions are at increased risk for severe dengue.”
  • Beckers Hospital Review lets us know,
    • “Teva Pharmaceuticals is launching the first authorized generic of Victoza, the first generic GLP-1 product available in the United States.
    • “By launching an authorized generic for Victoza (liraglutide injection 1.8mg), we are providing patients with type 2 diabetes another option for this important treatment,” Ernie Richardsen, SVP, Head of U.S. Commercial Generics at Teva, said in a June 24 news release.”
  • Highlighting the importance of a generic GLP-1 product is this Wall Street Journal article reporting that
    • “Blockbuster obesity drug Wegovy has been approved in China, opening the door for maker Novo Nordisk to begin selling it in the world’s second-largest economy, where the appetite for similar treatments is surging. * * *
    • “Novo Nordisk’s Ozempic drug—which contains the same semaglutide active ingredient as Wegovy—was approved to treat diabetes in China in 2021. Sales of the drug in the country more than doubled on year in 2023, reaching 4.82 billion Danish kroner ($693.6 million).
    • “Demand for weight-loss drugs is surging in China, where the proportion of overweight and obese adults reached almost 51% in 2022, creating a frenzy among local manufacturers to develop their own versions of the popular treatments, especially as Novo Nordisk’s semaglutide patent expires there in 2026, which will pave the way for generic versions.”
  • MedPage Today notes,
    • “Disrupted circadian rhythms in cognitively normal adults were tied to higher subsequent amyloid-beta levels, prospective data showed.
    • “Higher daily variability at baseline — an indicator of fragmented 24-hour activity rhythms — was associated with higher PET amyloid burden 8 years later (β=0.15, P=0.02) after adjusting for age, sex, APOE4 status, and other factors, according to Julia Neitzel, PhD, of Erasmus University Medical Center in Rotterdam, the Netherlands, and co-authors. * * *
    • “Considerable interest surrounds the role of sleep dysfunction in the development of Alzheimer’s disease and dementia,” observed Matthew Pase, PhD, of Monash University in Victoria, Australia, who wasn’t involved with the study.
    • “If poor sleep contributes to dementia, improving sleep symptomatology could be one strategy to lower dementia risk,” he told MedPage Today.
  • NPR discusses why “Your gut microbes may influence how you handle stress.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “The University of Alabama System’s board of trustees unanimously approved an agreement to acquire Ascension St. Vincent’s Health System.
    • “Birmingham-based UAB will assume ownership of all Ascension St. Vincent’s care sites under the agreement, announced June 25. The transaction still needs approval from federal regulators and the Catholic Church. UAB and Ascension expect the $450 million deal to close in the fall of 2024, according to the Shelby County Reporter.
  • and
    • identifies the twenty most socially responsible hospitals in the U.S., per Lown Institute. Duke Regional Hospital, in Durham, NC, leads the pack.
  • Per Fierce Pharma,
    • “Physicians don’t mind patients choosing at-home testing options over coming in for an in-person clinic visit—in fact, they overwhelmingly support it, according to the results of a new survey.
    • “Ixlayer’s report this week is based on a poll of more than 140 U.S. physicians representing a variety of specialties. All together, nearly 90% agreed that at-home tests are more convenient to many patients and can improve access to diagnostic care, and almost as many said they believe offering at-home testing options can help speed up diagnoses and, ultimately, improve patient outcomes.
    • “There is a large subset of my patients where making routine office visits is difficult, either complicated by age, travel time, costs, or time constraints. So I see having a convenient, at-home solution as a plus for improving medical care,” one of the survey’s respondents said.
    • “The overwhelming majority of the doctors surveyed, 91% of the group, said they were open to providing at-home testing kits to their patients, and 80% agreed that the remote tests could support or even enhance the healthcare system’s existing workflows.

Monday Roundup

David Ermer–CDC, FDA, Medical / Rx research, Mental health care, Obesity, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

From Washington, DC

  • MedPage Today reports about FDA Commissioner Robert Califf’s speech given this past weekend.
    • “We are wowing the world in technology — much of it related to the field that you’re interested in [diabetes],” he told attendees at the keynote opening session of the American Diabetes Association Scientific Sessions. “We are not succeeding in implementation of the things that we know. We need to bring these things together so that we harness technology, particularly digital technology and AI [artificial intelligence], to the benefit of the people that we care about.” * * *
    • “High fasting glucose, poor diet, and high BMI are all in the top five factors behind death and loss of disability-adjusted life years in the U.S. And according to some sources, diabetes has now surpassed cancer as the leader in the economic cost of healthcare in the U.S., with some 34 million adults having some form of diabetes in 2020, he said. “This is an honor I’m not sure I’d want to have, but it does give you a lot of power to do things to make this better.”
  • The American Hospital Association News tells us,
    • “The Department of Health and Human Services June 24 released a final rule that would disincentivize health care providers for interfering with the access, exchange or use of electronic health information. AHA previously expressed concern when the rule was proposed, saying it could threaten the financial viability of economically fragile hospitals.”
    • “In the final rule, hospitals under the Medicare Promoting Interoperability Program found to have committed information blocking would experience a reduction of the market basket update by 75%. Critical access hospitals would see a reduction from 101% to 100% of reasonable costs, while clinicians in Medicare’s Merit-based Incentive Payment System would receive a score of zero in the MIPS Promoting Interoperability performance category. Providers in accountable care organizations that commit information blocking would be ineligible to participate in the Medicare Shared Savings program for at least one year and may not receive revenue they may have earned through the program.” 
  • HHS adds,
    • “This HHS final rule complements OIG’s final rule from June 2023 that established penalties for information blocking actors other than health care providers, as identified in the Cures Act (health information technology (IT) developers of certified health IT or other entities offering certified health IT, health information exchanges, and health information networks). If OIG determines that any of these individuals or entities committed information blocking, they may be subject to a civil monetary penalty of up to $1 million per violation.
    • “The Office of the National Coordinator for Health Information Technology (ONC) and CMS will host a joint information session about the final rule on June 26, 2024, at 2 pm ET. More information can be found at healthit.gov/informationblocking and via ONC’s X account, @ONC_HealthIT 
  • Per Govexec,
    • “The U.S. Postal Service is not living up to its projected cost savings from its plan to overhaul the agency, according to a new [USPS Inspector General] audit, which found the 10-year initiative is no longer offering insight for measuring the success of the reforms. 
    • “USPS is bringing in more revenue than it anticipated when it first laid out its Delivering for America plan in 2021, though its costs have also accelerated in a way it did not project. That has led to overall losses of $950 million in fiscal 2022 and $6.5 billion in fiscal 2023, despite postal management predicting it would have broken even by now.” 
  • Fierce Healthcare lets us know,
    • “The [U.S.] Supreme Court will not hear a legal challenge to the nearly $2.7 billion Blue Cross Blue Shield [antitrust] settlement. * * *
    • In a statement to Reuters, BCBSA said it welcomes the decision as well as “the opportunity to begin to implement this settlement.”

From the public health and medical research front,

  • BioPharma Dive points out
    • “An experimental medicine helped people with a deadly heart disease stay out of the hospital and live longer in a closely watched clinical trial, a finding that could pave the way for a regulatory approval and help its developer, Alnylam Pharmaceuticals, rebound from a significant setback.
    • “Trial data released Monday showed trial participants with the disease, transthyretin amyloidosis cardiomyopathy, and treated with Alnylam’s drug had a 28% lower risk of death from any cause or recurrent cardiovascular event, compared to those given a placebo. Alnylam said its drug was associated with a 33% risk reduction versus placebo among people who weren’t on another drug for the condition, Pfizer’s tafamidis, at the study’s start.”
  • and
    • “Novo Nordisk on Sunday disclosed detailed clinical trial results for an experimental hemophilia treatment dubbed Mim8, showing once-weekly and once-monthly doses of the antibody drug controlled bleeding in people with the more common “A” form of the disorder.
    • “The data, which were presented at the International Society on Thrombosis and Haemostasis Annual Congress in Thailand, fill in a positive picture for Mim8’s effectiveness and safety. Novo had said in May that the Phase 3 trial, called Frontier-2, succeeded and shared topline findings.
    • “Among people who had not previously been on preventive treatment, researchers reported zero bleeds in 86% of study participants who received once-weekly Mim8, and 95% of those given the once-monthly dose. Those figures were 66% and 65%, respectively, among people in the trial who had prior preventive treatment.”
  • Per MedTechDive,
    • “Insulet is looking to expand the label for its Omnipod 5 insulin pump for people with Type 2 diabetes. The company said Friday it recently filed with the Food and Drug Administration. 
    • “Insulet presented study results at the American Diabetes Association’s 84th Scientific Sessions that evaluated Omnipod 5 in people with Type 2 diabetes who were taking basal insulin or multiple daily injections. The results showed “substantial improvements in blood glucose outcomes and overall quality of life,” said study chair Francisco Pasquel, an associate professor of endocrinology at Emory School of Medicine.
    • “Insulet’s filing comes as other diabetes technology companies look to expand their offerings for people with Type 2 diabetes. Tandem Diabetes Care has published results showing how its T:slim x2 pump with Control IQ improved time in range for people with Type 2 diabetes, and Dexcom and Abbott recently gained FDA clearance for continuous glucose monitors tailored for people with Type 2 who don’t take insulin.”
  • Per Beckers Hospital Review,
    • “Orlando, Fla.-based AdventHealth Cancer Institute launched a first-of-its-kind bladder cancer vaccine trial that will use patient-customized mRNA vaccines.
    • “The Phase II trial participants will receive pembrolizumab combined with a customized immunotherapy injection designed using the unique proteins present in each patient’s tumors, according to a May 23 system news release. Participants will receive infusions every six weeks for one year and then receive one vaccine injection every three weeks for nine doses.
    • “This vaccine is precision medicine at its best,” Guru Sonpavde, MD, medical director of genitourinary oncology at the AdventHealth Cancer Institute, as well as a member of the trial’s global steering committee, said in the release.”
  • The Centers for Disease Control last week released a report on loneliness in the U.S. 2022. The study found that loneliness was most prevalent among sexual and gender minorities.
  • STAT News notes,
    • “New research shows that, in spite of recommendations discouraging use of aspirin in primary prevention of cardiovascular disease among older adults, nearly a third of adults 60 years and older are still using it for this very purpose.
    • “The study, published on Monday in Annals of Internal Medicine, found that 18.5 million adults 60 and older without cardiovascular disease reported using preventative aspirin in 2021. Of those, 3.3 million were using the pills without medical advice. * * *
    • “John Wong, vice chair of the USPSTF, emphasized increased physician-patient conversations in deciding how to best prevent cardiovascular disease. “There are things at the individual level our population evidence-based recommendations don’t take into account,” Wong said.
    • “If a patient and their physician decide that daily aspirin is too risky, they can still plan to manage obesity, stop smoking, and regularly screen for high blood pressure and metabolic disease, said Wong. “Those are all evidence-based, proven methods to prevent that first heart attack or first stroke.”
  • Scientific American discusses exercises that can help older Americans reduce the risk of dangerous falls.
  • The Washington Post and Consumer Reports offer “tips can help you move [heavy] objects safely — and with less effort — even as you get older.

From the U.S. healthcare business front,

  • Fierce Healthcare explores UnitedHealthcare’s top selling health insurance product Surest.
  • Beckers Hospital Review explains why “Walgreens is on a mission to attain provider status for its pharmacists.” 
  • FiercePharma reports,
    • “GLP-1 heavyweights Eli Lilly and Novo Nordisk are trading haymakers as they scale up production to meet the overwhelming demand for their revolutionary obesity drugs.
    • “A month after Lilly revealed a $5.3 billion investment to increase its manufacturing capacity, Novo has answered.
    • “On Monday, the Danish drugmaker said it will spend $4.1 billion to construct a second fill-finish plant at its sprawling campus in Clayton, North Carolina. At 1.4 million square feet, the site will match the combined floor space of Novo’s three current manufacturing sites in the state, the company said.
    • “At the new plant, Novo will produce blood sugar modulating treatments Ozempic, for diabetes, and Wegovy, for obesity. The outlay is part of Novo’s planned $6.8 billion investment in manufacturing this year, up from $3.9 billion in 2023.”     

Weekend Update

David Ermer–Congress, Mental health care, SCOTUS, U.S. Healthcare–

From Washington, DC,

From the public health and medical research front,

  • CNN reports
    • “For some people with depression, finding the right medication can be a process of trial-and-error lasting for months or even years, which can worsen symptoms.
    • “But what if doctors, when diagnosing someone with depression, could assess exactly how depression is affecting a patient’s brain and prescribe a treatment that gets it right the first time?
    • “Scientists may be a step closer to that reality, thanks to new research that has identified six subtypes — or “biotypes” — of major depression via brain imaging combined with machine learning. The study, published Monday in the journal Nature Medicine, also tested how three of those biotypes responded to different antidepressants and therapies.”
  • The Washington Post published one of its occasional Medical Mysteries articles. In this case, the Post explains why a breastfeeding mother experience crippling back pain.

From the U.S. health business front,

  • NPR Shots’ “bill of the month” features a Texas urgent care center bill.
    • “One evening last December, Tieqiao Zhang felt severe stomach pain.
    • “After it subsided later that night, he thought it might be food poisoning. When the pain returned the next morning, Zhang realized the source of his pain might not be as “simple as bad food.”
    • “He didn’t want to wait for an appointment with his regular doctor, but he also wasn’t sure if the pain warranted emergency care, he said.
    • “Zhang, 50, opted to visit Parkland Health’s Urgent Care Emergency Center, a clinic near his home in Dallas where he’d been treated in the past. It’s on the campus of Parkland, the city’s largest public hospital, which has a separate emergency room.
    • “He believed the clinic was an urgent care center, he said.”
  • In short, this in-network facility, which Mr. Zhang visited. twice, turned out to be an extension of Parkland’s emergency room, and he was hit with a $19,543 bill on which he owed $1,000 in copayments. People should be placed on notice when they will be billed at hospital rates.
  • The Wall Street Journal adds,
    • “Rising healthcare prices have long eroded American wages. They are doing that by eating into jobs. 
    • “Companies shed workers in the year after local hospitals raise their prices, new research found. Higher hospital prices pushed up premiums for employees’ health insurance, which businesses help pay for. 
    • “The new study, scheduled to be published Monday as a National Bureau of Economic Research working paper, is a comprehensive look at one-way companies manage those higher premiums: cutting payrolls. 
    • “Employers that face increases in healthcare spending respond by laying off workers who they can no longer afford to retain,” said Zarek Brot-Goldberg, an economist at the University of Chicago and one of the researchers involved in the study. 
  • Fortune Well points out,
    • “Just what is the wellness level of today’s corporate workforce? That all depends on who you ask.
    • “Because while C-suite executives overwhelmingly believe their employees are feeling mentally healthy, professionally fostered, and personally satisfied and included, many workers themselves would beg to differ.
    • “That’s according to the findings of the third annual Workplace Well-being report from Deloitte. The audit and tax consultancy firm collaborated with independent researchers Workplace Intelligence to survey 3,150 executives, managers and workers across four countries (with 57% of respondents from the U.S., and others from the U.K., Canada, and Australia) to check in on the state of human sustainability—which is the degree to which an organization values people and leaves them with greater health and well-being, stronger skills for employability, opportunities for advancement, and a heightened connection to purpose. 
    • “A whopping 82% of executives believe their company is advancing human sustainability in general—but only 56% of workers agree.
    • “Other gulfs in understanding, according to the findings: Around 90% of executives believe working for their company has a positive effect on worker well-being, skills development, career advancement, inclusion and belonging, and their sense of purpose and meaning; only 60% of workers agree.
  • On the bright side, a majority of the workers are in the agreement with the C-suite execs. It could be worse.

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity policy front,

  • Federal News Network lets us know,
    • “Agencies that oversee critical infrastructure should address threats posed by China and work to establish baseline cybersecurity requirements over the next two years.
    • “That’s according to new guidance signed out by Homeland Security Secretary Alejandro Mayorkas on June 14. The document lays out priorities over the next two years for sector risk management agencies. SRMAs are responsible for overseeing the security of specific critical infrastructure sectors.
    • “From the banking system to the electric grid, from healthcare to our nation’s water systems and more, we depend on the reliable functioning of our critical infrastructure as a matter of national security, economic security, and public safety,” Mayorkas said in a statement. “The threats facing our critical infrastructure demand a whole of society response and the priorities set forth in this memo will guide that work.”
  • The Wall Street Journal adds,
    • “The U.S. government is pushing board directors at critical-infrastructure companies to improve cybersecurity oversight amid intense espionage and hacking campaigns from China and other adversaries.  “The U.S. government is pushing board directors at critical-infrastructure companies to improve cybersecurity oversight amid intense espionage and hacking campaigns from China and other adversaries.  
    • “On Tuesday [June 18], the U.S. Secret Service, the Cybersecurity and Infrastructure Security Agency, the National Association of Corporate Directors, credit card giant Mastercard and venture-capital firm NightDragon delivered a one-day course to 16 such directors.
    • “The attending directors, all of whom serve in leadership roles such as chairing audit committees on the boards of critical-infrastructure companies, sat for instruction at the Secret Service’s Laurel, Md.-based training facility. The course isn’t a primer on cybersecurity basics, but practical education on current threats and oversight.
  • The Washington Post reports,
    • “The Biden administration announced Thursday [June 20] that it will ban Kaspersky Lab from distributing its anti-virus software and cybersecurity products in the United States, pointing to national security concerns related to the Russian company.
    • “Commerce Secretary Gina Raimondo told reporters the decision was made following an “extremely thorough investigation,” and that Kaspersky has “long raised national security concerns.” The United States in 2017 banned federal agencies [and contractors] from using those products. * * *
    • “The ban on Kaspersky products comes into full effect Sept. 29, according to a statement from the Commerce Department. Until then, Kaspersky will be allowed to continue providing some services in the United States, including certain updates, to give U.S. consumers and businesses time to find alternatives.
    • “Individuals or businesses that continue to use the products will not face legal penalties, department said, but assume “all the cybersecurity and associated risks of doing so.”

From the cybersecurity vulnerabilities and breaches front,

  • Cybersecurity Dive informs us,
    • “At least 147,000 ASUS routers are potentially exposed to a critical vulnerability, which can allow a remote attacker to bypass authentication and gain login access, researchers at Censys said Thursday [June 20].
    • “ASUS issued a security advisory on June 14 recommending customers upgrade their firmware or apply mitigation steps if the upgrade was not possible.  
    • “The improper authentication vulnerability, listed as CVE-2024-3080, has a CVSS score of 9.8.”  
  • FEHBlog note — The Cybersecurity and Infrastructure Security Agency did not add new known exploited vulnerabilities to its catalog this week.
  • Cybersecurity Dive adds,
    • “Multifactor authentication appeared in almost half of all security incidents the Cisco Talos incident response teams encountered during the first quarter of the year, according to data released Tuesday. 
    • “In 25% of cases, incident response specialists responded to fraudulent MFA push notifications sent by attackers, Cisco Talos found.
    • “Users did not properly implement MFA in 1 in 5 Cisco Talos engagements, the firm said.”
  • Health IT Security tells us
    • “UnitedHealth Group (UHG) has begun notifying affected entities of the Change Healthcare data breach and will begin mailing breach notifications to individual cyberattack victims in late July, the company stated in a June 20 media notice.
    • “Change said it has completed a review of over 90% of impacted files and continues to see no evidence that full medical histories were exfiltrated from its systems during the cyberattack. Change explained that it only recently obtained a dataset that was safe to analyze, as its own systems were difficult to access during recovery.
    • “Even though the data review is not yet complete, Change has begun notifying the customers it has identified as impacted as of June 20 so they can proactively respond. * * *
    • “Change Healthcare’s latest update further confirmed that the company will make HIPAA and state attorney general notifications on behalf of victim entities unless those entities decide to opt out and handle the notifications themselves.
    • “The affected information varied by individual but may have included contact information, health insurance information, billing and claims information, medical record numbers, diagnoses, test results, Social Security numbers, and other personal information.
    • “Change offered two years of complimentary credit monitoring and identity theft protection services to victims and said that it reinforced its security and privacy policies in light of the incident.

From the ransomware front,

  • NPR reflects on the ransomware attack on Ascension Health.
  • CIS0 Series adds,
    • “As many as 10 companies are facing ransom payments between $300,000 and $5 million following a breach against cloud-based data analytics firm Snowflake earlier this month. According to Mandiant, who has helped lead Snowflake’s case, the hacking scheme has “entered a new stage” as the ransom demands flow in, as well as death threats against the cybersecurity experts investigating the breach. The hackers gained access to the information by targeting Snowflake users using single-factor authentication techniques. Mandiant has said it anticipates the ransomware group to “continue to attempt to extort victims.”
  • The American Hospital Association News tells us,
    • “The Department of Health and Human Services’ Health Sector Cybersecurity Coordination Center (HC3) this week released an advisory about Qilin, formerly “Agenda,” a ransomware-as-a-service group targeting health care and other industries worldwide. The group was observed recruiting affiliates in late 2023, and has variants written in Golang and Rust, HC3 said. Qilin is known to gain initial access through spear phishing, as well as leveraging remote monitoring and management and other common tools in cyberattacks. The group is also known to practice double extortion. HC3 said the group’s targeting appears to be opportunistic rather than targeted.” 
  • Per Cybersecurity Dive,
    • “Crime is paying less often for threat actors as improved corporate security measures — and dramatically higher ransom demands — sway more companies to reject extortion payments for seized data.
    • “Less than a quarter of 1,800 companies that submitted cyber claims to Marsh, or 23%, paid ransom demands last year, despite a 64% jump in extortion events from 2022 to a record 282, the insurance broker and risk advisor said in a June 11 report. 
    • “In 2021, Marsh noted, 63% of its clients paid an extortion demand to protect data.
    • “Companies, especially larger ones, are “just more resilient than they were three, four, five years ago,” Meredith Schnur, managing director of Marsh’s U.S. and Canada cyber practice, told Legal Dive.”

From the cybersecurity defenses front,

  • Dark Reading explains why multi-factor authentication is not enough while Tech Radar points out why we need a password-less world.
  • Tech Target gives advice on how to write a useful cybersecurity incident report.
  • Here’s a link to this week’s CISO Corner in Dark Reading.

Friday Factoids

David Ermer–AHRQ, CDC, Congress, Employee Wellness Programs, Medical / Rx research, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • STAT News reports,
    • “A House panel is exploring holding a vote on scaled-back versions of two major health care bills that would expand Medicare’s coverage of cancer screening tests and hugely popular weight loss drugs, five sources familiar with the planning told STAT. * * *
    • The two pieces of legislation are the Treat and Reduce Obesity Act, which would allow Medicare to cover obesity drugs and enable more health care providers to provide intensive behavioral therapy for obesity to Medicare patients, and the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act, which would allow Medicare to cover multi-cancer blood tests to screen healthy people for cancer. * * *
    • “Full Medicare coverage for both items has broad bipartisan support, but the expansion has been hampered by the likely exorbitant price tags to the federal government. If the House Ways and Means Committee is able to scale back the measures to a more palatable price point, it could increase their chance of passage.
    • “It is unclear how the bills could be limited to decrease their cost, and whether such pared-down proposals could achieve the bipartisan support that would be necessary to make the bills candidates for inclusion in a health care package that’s expected at the end of the year.”
  • BioPharma Dive informs us,
    • “Peter Marks is again at the center of a controversial Food and Drug Administration decision on a gene therapy for Duchenne muscular dystrophy. Twice now, the high-ranking FDA leader has pushed aside objections from agency reviewers to grant an approval to Sarepta Therapeutics’ treatment for the muscle-wasting condition.
    • “On Thursday, the FDA substantially broadened use of that treatment, called Elevidys. The decision makes Elevidys available to approximately 80% of people in the U.S. with Duchenne, which has limited treatment options and no cure. The agency also converted Elevidys’ accelerated approval to full, securing its place on the market. Previously, Elevidys was only approved for a specific group of boys 4 or 5 years of age.
    • “[D]ocuments published by the FDA expose a rift within the agency over Elevidys. Three FDA review teams and two top officials recommended Sarepta’s application be rejected due to insufficient and conflicting clinical data. They were overruled by Marks, head of the FDA center that reviews gene therapies, who found the results supportive enough to broaden Elevidys’ label. It’s now cleared for Duchenne patients over the age of 4 with mutations to a specific gene, regardless of whether they can still walk.
    • “I come to a different conclusion regarding the overall interpretation of the data,” Marks wrote in a memo. * * *
    • “The lasting impact of the approval will likely shape the FDA and gene therapy space for some time,” wrote Tim Lugo, an analyst at the investment bank William Blair, in an investor note Thursday. “We believe a more patient focused and less adversarial FDA review process is likely to continue across several areas in the agency, especially for heterogenous and deadly diseases with few good treatment options.”
  • This morning, the 5th Circuit issued in its opinion in a case challenging the authority of the U.S. Preventive Services Task Force (USPSTF) to make binding preventive services recommendations under the Affordable Care Act. The Court agreed with the lower court that USPSTF members are principal officers of the U.S. due to the binding nature of their recommendations. (HHS argued unsuccessfully that they were inferior officers.). Under the Constitution, the President must appoint principal officers with the advice and consent of the Senate. 
  • The Court granted relief to the individual plaintiffs but rejected the district court’s grant of universal injunction against enforcement of USPSTF recommendations since ACA enactment. The Court remanded the case to the district court for further proceedings.
  • The political ball is in the Biden Administration’s court.

From the public health and medical research front,

  • The Centers for Disease Control tells us,
    • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is increasing in some areas.
    • “COVID-19
      • “COVID-19 test positivity has increased to 6.6% from 5.4% in the previous week. Emergency department visits for COVID-19 are also increasing nationally. Wastewater viral activity is showing increases in some states. We also estimate that COVID-19 infections are growing or likely growing in 39 states and territories, declining or likely declining in 0 states or territories, and are stable or uncertain in 10 states and territories, based on CDC modeled estimates of epidemic growth. KP.3 and LB.1 are projected to continue increasing as proportions of the variants that cause COVID-19 (CDC COVID Data Tracker: Variant Proportions).
    • “Influenza
    • “RSV
      • “Nationally, RSV activity remains low.
    • “Vaccination
  • Health Day lets us know,
    • “A medication used to manage type 2 diabetes has been found effective in treating sleep apnea.
    • “The worldwide clinical trial demonstrates that tirzepatide significantly lowers breathing interruptions during sleep, a key indicator of the severity of a patient’s obstructive sleep apnea (OSA).
    • “Tirzepatide is one of the class of blockbuster GLP-1 medicines, sold as Mounjaro to fight diabetes and as Zepbound to help with weight loss.
    • “This study marks a significant milestone in the treatment of OSA, offering a promising new therapeutic option that addresses both respiratory and metabolic complications,” said study leader Dr. Atul Malhotra, director of sleep medicine at UC San Diego Health. * * *
    • “The findings, published June 21 in the New England Journal of Medicine, add to evidence that a drug targeting both apnea and obesity is better than treating either condition on its own. Researchers said the drug therapy improved other aspects related to OSA, such as improving weight. Some patients, however, had mild stomach issues.”
  • Medscape notes, “Individuals on an intermittent-fasting and protein-pacing (IF-P) diet had fewer gastrointestinal symptoms and increased diversity in gut microbiota than those on a calorie-restricted (CR) Mediterranean-style diet in a small, randomized trial.”
  • The Assistant Secretary of Labor for Employee Benefit Security writes in her blog that “For Men, Taking Care of Your Family Means Taking Care of Yourself.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “Risant Health, a nonprofit formed under Oakland, Calif.-based Kaiser Permanente, has signed a definitive agreement to acquire Greensboro, N.C.-based Cone Health.
    • “The news comes less than three months after Risant acquired its first health system, Danville, Pa.-based Geisinger Health. 
    • “If the transaction closes, Cone Health will operate independently as a regional and community-based health system under Risant, which supports organizations with technology and services to improve outcomes and lower care costs in diverse business models.
    • “Cone Health’s impressive work for decades in moving value-based care forward aligns so well with Risant Health’s vision for the future of healthcare. Their longstanding success and deep commitment to providing high-quality care to North Carolina communities make them an ideal fit to become a part of Risant Health,” CEO, Jaewon Ryu, MD, said in a June 21 news release. “We will work together to share our industry-leading expertise and innovation to expand access to value-based care to more people in the communities we serve.” 
    • “Cone Health includes four acute-care hospitals, a behavioral health facility, three ambulatory surgery centers, eight urgent care centers and more than 120 physician practices, according to its website. It has more than 13,000 employees and over 700 physicians, along with 1,800 partner physicians.” 
  • Per Healthcare Dive,
    • “Steward Health Care this week pushed back the auction timeline for the sale of its physician group and about half of its hospitals — less than a week before bids were due.
    • “The delay impacts the sale of Arizona and Massachusetts hospitals as well as the St. Joseph Medical Center in Texas. The new deadline for bids is July 15, with an auction following July 18 and a proposed sales hearing on July 31. Steward did not change the timeline for the sale of its other assets.
    • “One expert told Healthcare Dive it was “very possible” Steward would delay the sale timeline again if creditors agreed it was the best business move — especially since the company just re-upped its debtor-in-possession financing, which provides cash to fund operations through restructuring.”
  • and
    • “Telehealth use declined across most sociodemographic groups from 2021 to 2022, according to a survey published Thursday by the National Center for Health Statistics.
    • “Thirty-seven percent of adults reported using telemedicine in the past 12 months in 2021, compared with just over 30% in 2022.
    • “Researchers noted the decline across nearly all groups studied, including sex, family income, education and region. Women, adults with at least a college degree and people living in more urban areas were more likely to use telehealth in 2022.” 
  • Per Fierce Healthcare,
    • “An innovation council brought together some of the nation’s largest health plans to raise issues and look for ways to improve complex processes, including credentialing and provider data management.
    • “It’s one of the first times payers have sat down together to solve these pain points, CAQH CEO Sarah Ahmad told Fierce Healthcare in an interview. The health plan representatives met in-person just one day before AHIP 2024 kicked off in Las Vegas last week.
    • “You don’t see that in healthcare these days,” said Ahmad, whose company assembled the leaders.
    • “CAQH is a provider data management company that works on the provider side to credential and handle directory management, and on the member side to handle coordination of benefits.”
  • HR Dive offers five stories on the rise of wellness benefits.

Thursday Miscellany

David Ermer–Congress, Electronic health records, FDA, Medical / Rx research, Mental health care, NIH, Obesity, U.S. Healthcare–
Photo by Josh Mills on Unsplash

Happy Summer Solstice in our northern hemisphere of Mother Earth.

From Washington, DC,

  • Federal News Network lets us know,
    • “With both Senate and House lawmakers advancing legislation that aligns with President Joe Biden’s 2% federal pay raise request, civilian federal employees appear to be a step closer to a smaller pay bump for 2025.
    • “The Senate Armed Services Committee’s version of the fiscal 2025 National Defense Authorization Act last week showed support for a 2% raise for DoD civilian workers and a 4.5% raise for military members. In a vote of 22-3 on June 13, committee lawmakers advanced the 2025 NDAA to the full Senate for consideration. The House passed its version of the NDAA last week.
    • “Although the NDAA’s provisions only apply to Defense Department employees, both civilian DoD workers and the rest of the civilian federal workforce on the General Schedule would see the same percentage added to their paychecks, if the raise is enacted.
    • “In House appropriations legislation, committee lawmakers remained silent on the topic of the federal pay raise, indicating a likely alignment with the president’s raise proposal. The GOP-led committee advanced legislation for a fiscal 2025 spending package last week along party lines. The Senate Appropriations Committee has not yet released its versions of fiscal 2025 spending legislation.”
  • The American Hospital Association News tells us,
    • “A United States District Court Judge in Texas today ruled in favor of the AHA, Texas Hospital Association, and hospital plaintiffs, agreeing that Department of Health and Human Services “bulletins” that restrict health care providers from using standard third-party web technologies that capture IP addresses on portions of their public-facing webpages were unlawful final rules and vacating the March 2024 Revised Bulletin.
    • “It’s easy for eyes to glaze over at a thirty-page opinion discussing the administrative esoterica accordant with HIPAA compliance,” United States District Court Judge Mark Pittman wrote today. “But this case isn’t really about HIPAA, the Proscribed Combination, or the proper nomenclature for PHI in the Digital Age. Rather, this is a case about power.…  While the Proscribed Combination may be trivial to HHS, it isn’t for covered entities diligently attempting to comply with HIPAA’s requirements.…  The Court GRANTS the Hospitals’ request for declaratory judgment and DECLARES that the Proscribed Combination, as set forth in the HHS Bulletin of March 18, 2024, is UNLAWFUL, as it was promulgated in clear excess of HHS’s authority under HIPAA.”
  • Bravo!
  • In an interview with Healthcare Dive, Micky Tripathi, the National Coordinator for Health Information Technology, discusses his agency’s artificial intelligence strategy.
  • The House Committee on Education and the Workforce announced that “On Thursday, June 27, at 10:15 a.m., the Subcommittee on Health, Employment, Labor, and Pensions, chaired by Rep. Bob Good (R-VA), will hold a hearing titled “Examining the Policies and Priorities of the Employee Benefits Security Administration.”
  • Kevin Moss, writing in the Federal Times, reminds postal annuitants over the age of 65 and without Medicare Part B about the ongoing, late enrollment penalty free Special Enrollment Period. available to future PSHBP members.
  • BioPharma Dive reports,
    • “The Food and Drug Administration has substantially loosened limits on the first gene therapy for Duchenne muscular dystrophy in a decision that could greatly expand its use even as questions remain about its effectiveness.
    • “The agency on Thursday made the therapy, called Elevidys and sold by biotechnology company Sarepta Therapeutics, available to people with Duchenne who are at least four years of age and have mutations in a specific gene, regardless of whether they can still walk.
    • “For those who are still ambulatory the agency also converted Elevidys’ conditional approval to full, meaning its market availability in that setting is no longer contingent on additional tests. The clearance for Duchenne patients who are non-ambulatory is conditioned on the results of a Phase 3 study called Envision that’s currently underway.”

From the public health and medical research front,

  • Cardiology Business informs us,
    • “The American College of Cardiology (ACC) this week published a report card on the excess cardiovascular mortality among Black Americans between 2000-2022.[1] The ACC said it highlights the “persistent and tragic inequities” in cardiovascular care and outlines the years of life lost to the Black community because of higher cardiovascular disease death rates.
    • “The report showed the Black population experienced 1.6 million excess deaths overall and millions of potential life-years lost. Heart disease was the leading cause of age-adjusted excess mortality among Black Americans. This includes deaths due to ischemic heart disease, hypertension, cerebrovascular disease and heart failure.
    • “Our study reveals that Black Americans, because of their higher cardiovascular mortality rates compared with white Americans, have suffered almost 800,000 excess deaths, which translates to about 24 million additional years of life lost between 2000 and 2022,” Journal of the ACC incoming editor-in-chief Harlan M. Krumholz, MD, SM, FACC, who is also senior author of the study, said in a statement. “This staggering figure highlights the critical need for systemic changes in addressing cardiovascular inequities.”
    • “Krumholz said the goal of the report card is to promote accountability and serve as a catalyst for action that addresses the ongoing problem.”
  • The National Institutes of Health’s Director writes in her blog,
    • “Drug-resistant bacteria are responsible for a rise in serious, hospital-acquired infections, including pneumonia and sepsis. Many of these bacteria are classified as “gram-negative,” and are harder to kill than “gram-positive” bacteria. Unfortunately, the limited number of antibiotics that can help combat these dangerous infections can also damage healthy microbes in the gut, leaving people at risk for other, potentially life-threatening infections. Such antibiotic-induced disruption has also been linked in studies to irritable bowel syndrome, colon cancer, and many other health conditions.
    • “There’s a great need for more targeted antibiotics capable of fending off infectious gram-negative bacteria while sparing the community of microbes in the gut, collectively known as the gut microbiome. Now, in findings reported in the journal Nature , a research team has demonstrated a promising candidate for the job. While the antibiotic hasn’t yet been tested in people, the findings in cell cultures suggest it could work against more than 130 drug-resistant bacterial strains. What’s more, the study, supported in part by NIH, shows that this compound, when given to infected mice, thwarts potentially life-threatening bacteria while leaving the animals’ gut microbiomes intact. * * *
    • “These new findings, while promising, are at an early stage of drug discovery and development, and much more study is needed before this compound could be tested in people. It will also be important to learn how rapidly infectious gram-negative bacteria may develop resistance to lolamicin. Nevertheless, these findings suggest it may be possible to further develop lolamicin or related antibiotic compounds targeting the Lol system to treat dangerous gram-negative infections without harming the microbiome.”
  • Per an NIH press release,
    • “Researchers at the National Institutes of Health (NIH) have developed a non-chemotherapy treatment regimen that is achieving full remissions for some people with aggressive B-cell lymphoma that has come back or is no longer responding to standard treatments. The five-drug combination targets multiple molecular pathways that diffuse large B-cell lymphoma (DLBCL) tumors use to survive.
    • “In a clinical trial at NIH’s National Cancer Institute, researchers tested the combination of venetoclax, ibrutinib, prednisone, obinutuzumab, and lenalidomide (called ViPOR) in 50 patients with DLBCL, the most common type of lymphoma. The treatment shrank tumors substantially in 26 of 48 (54%) evaluable patients, with 18 (38%) of those patients’ tumors disappearing entirely, known as a complete response. At two years, 36% of all patients were alive and 34% were free of disease. These benefits were seen mainly in people with two specific subtypes of DLBCL.
    • “The findings were published June 20, 2024, in the New England Journal of Medicine.
  • NIH also posted the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)  Director’s Update for Summer 2024.
  • STAT News points out,
    • “Gestational diabetes affects one in seven expecting women globally and rates of this troubling condition are rising. Blood glucose levels that become elevated for the first time during pregnancy can lead to severe complications, such as preeclampsia, and increase the risk of stillbirth. And while the condition typically resolves after birth, it is linked to a tenfold increase in the risk of developing type 2 diabetes, along with risks for the child including obesity, cardiovascular disease, and neurodevelopmental disorders. 
    • “Gestational diabetes has long been diagnosed between weeks 24 and 28 of pregnancy. But a recent randomized control study called Treatment of Booking Gestational Diabetes Mellitus, or TOBOGM, which was started in 2018 and whose results were published earlier this year, found that treating gestational diabetes before week 20 reduced the risk of severe perinatal complications, including preterm birth, low birthweight, stillbirth, and respiratory distress. The early treatment was most effective in women who had high blood glucose levels after an oral glucose tolerance test, which measures how well the body can metabolize the sugar in a very sweet, Gatorade-like drink. 
    • “In some cases, women are tested early when they have risk factors such as high blood pressure, obesity, or previous gestational diabetes. But between 30% and 70% of all gestational diabetes cases could be detected much earlier — by the twentieth week of a pregnancy, according to a series published on Thursday in The Lancet by an international group of gestational diabetes researchers.” 
  • and
    • When they work, immunotherapy drugs called checkpoint inhibitors can shrink cancers and, in some cases, eradicate tumors altogether. These drugs, which include Keytruda and Opdivo, are prescribed to hundreds of thousands of patients a year for dozens of different kinds of cancer — but they only work for a minority of them. Most patients ultimately end up progressing or relapsing.
    • In two separate [small] clinical trials published in Science on Thursday, researchers found that adding a drug called a JAK inhibitor created an unexpected synergy with checkpoint inhibitor therapy. The combination helped a majority of patients respond to the immunotherapy and, in one trial, overcome resistance to checkpoint inhibitors.
  • Per Biopharma Dive,
    • “Twice-yearly shots of a Gilead Sciences HIV drug were so effective at preventing infections in a large late-stage clinical trial that study monitors recommend the company stop testing early and offer the drug to all participants.
    • “The trial, called Purpose 1 and run in South Africa and Uganda, compared Gilead’s medicine lenacapavir to once-daily Truvada and background HIV infection rates among cisgender women. Lenacapavir proved superior to both, with zero HIV infections reported in the study group, Gilead said Thursday.
    • “Gilead hopes testing of twice-yearly lenacapavir will prove it an effective and more convenient preventive option for people at risk of HIV infection. The company expects data late this year or early next from another study that involves cisgender men who have sex with men as well as certain groups of people who are transgender or gender non-binary.”
  • Optum discusses “New innovative treatments for hemophilia B, RSV, COPD” in its new edition of its Drug Pipeline Insights Report.
  • Per Medscape,
    • “A single course of treatment with emotional awareness and expression therapy (EAET) was associated with a significantly greater reduction in chronic pain severity than cognitive-behavioral therapy (CBT), the current psychotherapeutic gold standard, a new study suggested.”
    • “Two thirds of the patients who received EAET reported at least a 30% reduction in pain compared with 17% of those who received CBT. The randomized clinical trial also showed that individuals with depression and anxiety responded more favorably to EAET, a novel finding.
    • The study is one of only a few to directly compare EAET with CBT.”

From the U.S. healthcare business front,

  • Mercer Consulting notes,
    • “Despite higher healthcare cost trends, fewer than half of large employers (those with 500 or more employees) are likely to take cost-cutting measures next year like raising deductibles or copays, according to Mercer’s new Survey on Health and Benefit Strategies for 2025, with nearly 700 employer participants.
    • “Heading into 2025, employers face the challenge of addressing sharply faster cost growth while keeping healthcare affordable for their workers and offering a competitive benefit package. The survey found that medical plan options that save money by steering employees to quality, cost-efficient health providers — and potentially offer members more affordable coverage – now have significant traction with employer health plan sponsors.
    • “These plans take different forms, but over a third of large employers (36%) are now utilizing high-performance network plans or other alternative medical plans, and 29% are considering it in the near-term. * * *
    • “Many large employers indicated they want a consistent offering nationally. If this is a key priority, then an employer could explore the newer variable copay health plan options or high-performance network products offered by certain national carriers that can backfill with their broad network as needed in some geographies for a consistent national offering. Further, while considering disruption to members is important, it shouldn’t mean avoiding change entirely. A high-performance network option could be offered as a choice at enrollment that provides a richer benefit design or lower payroll contribution option as a tradeoff for the different network.
    • “Additionally, the prevalent variable copay plan options are built on top of national broad network options, so in most cases provider disruption would be minimal.
  • Newfront discusses ten spousal incentive HRA compliance considerations. Spousal incentive HRAs are health reimbursement accounts offered to employees who elect primary coverage from their spouse’s group health plan.
  • Beckers Payer Issues relates,
    • “Humata Health, a company that uses AI and machine learning to streamline prior authorization for payers and providers, has closed a $25 million investment. 
    • “The funding was led by Blue Venture Fund (majority of BCBS plans) and LRVHealth (nearly 30 health systems and payers), with participation from Optum Ventures, .406 Ventures, Highmark Ventures and VentureforGood, according to a June 20 news release.
    • “The company said it will use the funding to broaden the scope of its generative AI technologies, expand its customer base, and begin partnering with payers and other entities. Founded in 2023, the company has already partnered with 225 hospitals.”
  • The Wall Street Journal reports,
    • “Eli Lilly is stepping up its campaign against fake and counterfeit weight-loss drugs with more lawsuits against sellers of unapproved products that market themselves as Mounjaro and Zepbound.
    • “The pharmaceutical company said Thursday that it has filed legal actions against med-spas, wellness centers and other entities that sell products purportedly containing tirzepatide, the antidiabetic medication Eli Lilly sells under the brand names Mounjaro and Zepbound.”
  • STAT News interviews Bold Health’s CEO Amanda Rees on “fall prevention, ageism in health care, and ‘movement is medicine’.”
    • “When Amanda Rees was in her twenties she moved in with her grandmother, who was in her 80s, and saw first-hand the issues older adults face with falls and balance. “It really radicalized how I thought about aging,” she said. Serving as her grandmother’s caretaker inspired her to shift into health care and start Bold, a health tech startup that provides at-home digital exercise programs targeted at adults 65 and older.  
    • “Falls among older adults cost the health care system about $50 billion annually, according to the CDC. Rees hopes Bold can help older adults build strength, prevent falls and reduce hospitalizations. The Los Angeles-based startup works with Medicare Advantage members and raised $17 million during its Series A. Rees sat down with STAT to discuss building Bold, the concept of  “movement is medicine,” and the public health crisis of falls.”

Midweek update

David Ermer–CDC, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Derek Lamar on Unsplash

Happy Juneteenth and RIP Willie Mays.

  • Federal News Network lets us know,
    • “Especially in the federal government, change often happens slowly. But the Office of Personnel Management said it’s seeing early indications that its efforts to reform federal recruitment are starting to pay off.
    • “OPM’s initiatives over the last couple years, such as banning the consideration of salary history, creating a job portal for internship openings, and broadening eligibility for paid internships through the Pathways Program, all aim to open the doors to more candidates and make the hiring process more equitable.
    • “Even though the larger impacts of those changes are likely still further down the road, OPM Acting Director Rob Shriver said signs are pointing in the right direction, especially for OPM’s efforts centered on improving recruitment and retention of younger employees.”Even though the larger impacts of those changes are likely still further down the road, OPM Acting Director Rob Shriver said signs are pointing in the right direction, especially for OPM’s efforts centered on improving recruitment and retention of younger employees.
    • “I do think what we’re seeing is a renewed and increased interest in federal job opportunities by early-career talent,” Shriver told Federal News Network Tuesday during an event for federal interns hosted at OPM’s headquarters office.”

From the public health and medical research front,

  • MedPage Today informs us,
    • “Increasingly, research is coming out in favor of drinking as little as possible — but the exact level of risk hasn’t been made clear, according to the New York Times.
    • “A recent meta-analysis of 107 studies found that no amount of alcohol consumption improved health. It had come after one scientist noticed that many alcohol studies had a fundamental flaw: they included ex-drinkers in their “abstainers” group, who may have stopped drinking because of illness.
    • “By comparison, moderate drinkers looked healthier, according to the Times. The reevaluation found a statistically significant increase in all-cause mortality for women who drank under two drinks a day, and men who had more than three. Another study found that even one or two drinks daily can shrink the brain.
    • “So how should people think about their risk? Someone who has two drinks a week could shave a week off their life, and seven drinks a week could shave off 2.5 months, a researcher told the Times. But consume five drinks a day, and it may cost 2 years.
  • STAT News reports,
    • “For members of a large extended Colombian family, an early Alzheimer’s diagnosis is practically a grim guarantee. But new research further supports the idea that a rare genetic mutation can delay the devastating disease’s onset. * * *
    • “The findings, published on Wednesday in the New England Journal of Medicine, come five years after this research team identified a woman in the Colombian family who had two copies of the Christchurch mutation and developed Alzheimer’s 30 years later than expected. That finding suggested that the mutation had protected her, but outside researchers pointed out that it was hard to say for certain based on a single person. And they added that the mutation’s putative protection would be more convincing if researchers could show a more modest disease delay in people with one copy of the variant, found in a gene coding for a form of the protein apolipoprotein E, or APOE.
    • “The Alzheimer’s field has long been focused on removing amyloid plaques to slow disease, and the Food and Drug Administration is widely expected to approve one such drug from Eli Lilly after approving an anti-amyloid therapy from Biogen and Eisai. But the new study adds to growing evidence that supports targeting APOE. Some efforts to develop drugs that mimic the Christchurch mutation’s effects are already underway. The new study’s senior author, Joseph F. Arboleda-Velasquez, a cell biologist at Mass Eye and Ear, said these latest findings add fresh urgency to that work.”
  • Medscape adds,
    • “Healthy behaviors have been linked to a lower risk for Alzheimer’s disease (AD) but may also benefit patients already diagnosed with mild cognitive impairment (MCI) or early AD, new research suggested.
    • “After 20 weeks, patients following an intensive multimodal lifestyle intervention showed significant improvements across three measures of cognition and function and less progression on one measure when compared with usual care.”
  • Forbes tells us,
    • “Health officials across the continental U.S. are starting to warn about the annual return of West Nile virus, a potentially lethal human disease without treatments or vaccines that is rearing its head earlier than usual as the changing climate makes the environment more hospitable for the mosquitoes that spread it.”

From the U.S. healthcare business front,

  • MedCity News offers an interview with Erin Fox, PharmD, MHA, who has tracked drug shortages for more than 20 years and sees no easy solutions for what has become a record run.
    • “Q: Are there any signs that this is letting up?
    • “A: Unfortunately, no. We haven’t necessarily solved some of the root causes.
    • “We have, overall, relatively few manufacturers. [FDA] halted inspections during COVID. Now they’re back, at factories that maybe haven’t been inspected for 5 or 6 years. They’re finding some things to fix. Those fixes can take anywhere from 6 to 18 months for production to get fully back on schedule.
    • “Meanwhile, other companies don’t necessarily have the capacity to ramp up production to make up the difference.
    • “It’s not the FDA’s fault. We want them to find those quality deficits. But when FDA goes out looking all at once, it can be pretty disruptive.
    • “Q: What are the typical drugs that land on the shortage list?
    • “A: Generic, injectable hospital drugs, or older drugs. They are usually pretty low cost. There’s not a lot of resilience in the supply chain for another company to make up the difference.
    • “We saw all those chemotherapy shortages last year in part because a large factory in India, (the FDA) found quality problems there. They made a large amount of the U.S. supply. The other companies were unable to quickly make up the difference.
  • Beckers Hospital Review identifies five drugs that recently wound up on the shortage list.
  • MedCity News share “Nine Requirements for an Optimal Genetic Test Benefit Program” under health plan coverage.
    • Why? “An estimated 180,000 genetic tests are on the market, with an average of 10 new tests added daily. CPT coding has yet to keep up. Only about 500 CPT codes are used for 360 times the number of tests. The resulting system is slow, inefficient, expensive, and prone to waste, fraud, and abuse. Health plans need management programs designed specifically for genetic testing, which will only grow in volume and complexity.”
  • Fortune via Yahoo Finance offers an interview with “Tilak Mandadi [who] joined CVS in 2022 as EVP of ventures and chief digital, data, analytics and technology officer at CVS. [At that time,] there were separate teams running data, analytics, IT, and other technology functions. One of his earliest projects was to combine all of those functions into an integrated organization. He also appointed chief digital technology officers to oversee each of the company’s divisions.” Check it out.

Tuesday Tidbits

David Ermer–ACA, AHRQ, FDA, Medical / Rx research, Medicare, Obesity, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Healthcare Dive lets us know,
    • “The rate of uninsured Americans is expected to rise over the next decade, largely erasing coronavirus pandemic-era gains as subsidies for plans in the Affordable Care Act marketplaces and policy stipulations keeping low-income people on Medicaid expire, according to new projections from the Congressional Budget Office.
    • “This year, just 7.7% of Americans, or 26 million people, are uninsured, according to the CBO. In comparison, 10.3% or 33.2 million Americans were uninsured in 2019.
    • “Yet an estimated 1.7 million people — mostly working-age adults — will become uninsured on average every year until the uninsured rate swells to 8.9% in 2034, the CBO projects.”
  • Modern Healthcare reports,
    • “Novant Health ended its 16-month pursuit of a $320 million deal to acquire two North Carolina hospitals from Community Health Systems after a federal appellate court on Tuesday dealt it a harsh blow.
    • “The U.S. Court of Appeals for the Fourth Circuit hit Novant’s proposed acquisition of Mooresville-based Lake Norman Regional Medical Center when a panel voted 2-1 to grant the Federal Trade Commission’s motion to stop that proposal pending appeal. Lake Norman Regional Medical Center was one of two hospitals Novant sought to purchase from Community Health Systems, along with Statesville-based Davis Regional Medical Center.
    • “A Novant spokesperson said the health system doesn’t see a way to finalize the deal given the FTC’s “continued roadblocks.” Winston-Salem, North Carolina-based Novant announced plans in February 2023 to acquire the two hospitals from Franklin, Tennessee-based Community Health Systems.”
  • Beckers Hospital Review tells us,
    • “Spending on drugs purchased at discounted 340B prices across all participating facilities went up 19% annually between 2010 and 2021, according to a June 17 report from the Congressional Budget Office. 
    • “Established by Congress in 1992, the 340B drug pricing program allows qualifying hospitals and clinics that treat low-income and uninsured patients to purchase some drugs at a discounted rate of between 25% and 50% off their normal price.
    • “Enrollment in the 340B program has drastically increased in recent years, driving up spending and also leading to more disputes between covered entities who need to obtain affordable medications for uninsured or underinsured patients and drugmakers who need to protect company profits and resources. 
    • “Cancer drugs, anti-infective agents, and immunosuppressants accounted for 70% of total 340B spending in 2021 — up from 58% in 2010 — according to data from the Health Resources and Service Administration, which was analyzed by the Congressional Budget Office.” 
  • The U.S. Preventive Services Task Force today gave a B grade to a recommended that clinicians provide or refer children and adolescents 6 years or older with a high body mass index (BMI) (≥95th percentile for age and sex) to comprehensive, intensive behavioral interventions.
  • STAT News adds,
    • “On Tuesday, the United States Preventive Services Task Force issued recommendations encouraging clinicians to provide or refer children and adolescents 6 years or older with a high body mass index to comprehensive, intensive behavioral interventions. That counters last year’s recommendation by the American Academy of Pediatrics to consider obesity drugs for kids 12 and older whose weight tops growth charts, along with encouraging better nutrition, physical activity, and behavioral therapy from age 6 on up. 
    • “The USPSTF called evidence on the benefits of pharmacotherapy “inadequate” due to the small number of studies and limited data on long-term treatment harms, asserting that at least two years of follow-up are needed to gauge the long-term outcomes of drug therapy. That assessment would go beyond BMI to include metabolic health and psychosocial functioning, among other impacts. 
    • “Wanda Nicholson, task force chair and senior associate dean of diversity and inclusion at the George Washington University School of Public Health, said the evidence is clear to support high-intensity behavioral interventions to help children and adolescents lose weight and gain better quality of life. It’s less than clear for the four drugs discussed in the task force’s analysis of current research, she said. The drugs are semaglutide (sold as Wegovy for weight loss/Ozempic for diabetes), liraglutide (Saxenda/Victoza), orlistat (Xenical, Alli), and phentermine/topiramate (Qsymia). * * *
    • “A child’s BMI — a measure many view as flawed — is considered high if it’s at or above the 95th percentile for age or sex. Nearly 20% of U.S. children fall into that category. The prevalence of high BMI rises with age and is higher among Hispanic/Latino, Native American/Alaska Native, and non-Hispanic Black children and adolescents and among children from lower-income families. The dissonance between the USPSTF’s and the AAP’s positions does not address criticism voiced last year over whether the focus on weight instead of health is misplaced. * * *
    • “USPSTF guidance from 2017 focused on screening before intervention, but the new statement instead moves directly to behavioral methods to promote a healthy weight while stopping short of suggesting GLP-1 drugs such as Wegovy. It’s a recognition that screening has become a routine part of primary care.
    • “Those intensive behavioral interventions, intended to help children achieve a healthy weight while improving their quality of life, entail 26 or more hours over one year with a health professional. That might mean physical activity, support for weight-related behavior change, and information about healthy eating.”
  • MedPage Today also discusses today’s USPSTF recommendationj.

From the public health and medical reseaarch front,

  • The International Foundation of Employee Benefit Plans offers guidance on designing the best oncology benefits.
  • The National Cancer Institute posted its latest research highlights.
  • Beckers Hospital Review points out,
    • “Many physicians in obesity medicine have observed a trend among their patients: Those with obesity begin taking a weight loss drug like Wegovy, and their other chronic conditions improve or clear up entirely. “Many physicians in obesity medicine have observed a trend among their patients: Those with obesity begin taking a weight loss drug like Wegovy, and their other chronic conditions improve or clear up entirely. 
    • “As a result, some physicians are embracing an “obesity first” approach in which they treat obesity first with drugs approved for that purpose, anticipating other related conditions, such as high blood pressure and arthritis, will also improve as patients begin to lose weight, according to  a June 19 report from The New York Times. 
    • “We are treating the medical condition of obesity and its related complications at the same time,” Stefie Deeds, MD, an internist and obesity medicine specialist at a private practice in Seattle, told the Times. Dr. Deeds is also an assistant professor at the University School of Washington in Seattle. 
    • “The approach marks a shift from traditional medical practice in which patients with obesity are prescribed a number of medications to treat conditions that often accompany obesity, and advised to make diet and exercise changes. In some cases, patients are happy to be taking a single drug, experts said. 
    • “But there’s no firm consensus that this approach works, and not all physicians are on board. A primary care physician told the Times he leans toward an “obesity last” approach in which he starts by treating obesity-related conditions with drugs known to work for those conditions. If related conditions didn’t improve, only then would he discuss obesity drugs with patients.” 
  • MedPage Today notes, “Adding financial incentives to meal incentive therapies for for teens with severe obesity helped improve weight and body fat, but not cardiometabolic risk factors, a randomized study found.”
  • Per BioPharma Dive,
    • “Intra-Cellular Therapies plans to seek clearance to sell its medicine Caplyta for patients with depression after a second-late stage study of the drug succeeded. 
    • “Caplyta, also known as lumateperone, is currently approved for patients suffering from schizophrenia and depressive episodes associated with bipolar disorder. Intra-Cellular now wants to add major depressive disorder to the list.
    • T”he latest study followed 480 patients already medicated to treat depression. Patients who randomly received Caplyta as an add-on to existing therapy showed a significantly better response on scales that measure depression symptoms compared with participants who received a placebo, Intra-Cellular said Tuesday.”
  • The Washington Post reports for what it’s worth.
    • “Sedentary coffee drinkers had a 24 percent reduced risk of mortality compared with those who sat for more than six hours and didn’t drink coffee, according to the lead author of a study published recently in the journal BMC Public Health.”
    • “The finding, which was not part of the original article, was calculated at The Washington Post’s request and provided by Huimin Zhou, a researcher at the Medical College of Soochow University’s School of Public Health in China and the lead author of the study on coffee and health.”

From the U.S. healthcare business front,

  • MedTech Dive relates,
    • “Boston Scientific has agreed to acquire Silk Road Medical, a maker of stroke prevention devices, for $27.50 per share in cash, or an equity value of about $1.26 billion, the companies said Tuesday.
    • “Silk Road’s products are the only commercially available devices for use during a minimally invasive procedure called transcarotid artery revascularization (TCAR) to treat patients with carotid artery disease, according to Boston Scientific.
    • “We view the deal as largely inexpensive for Boston yet meaningful enough to move the needle on growth in the peripheral interventions business,” J.P. Morgan analyst Robbie Marcus said in a note to clients.”
  • Per Fierce Healthcare,
  • and
    • “Insured patients are often better off buying their generic prescriptions through their health insurance benefits than through Mark Cuban Cost Plus Drug Company, though those without insurance could find cost savings in over a quarter of their pharmacy fills, according to a study published Friday in JAMA Health Forum.
    • “Across a sample of nearly 844 million prescription pharmacy fills logged among 124 generic drugs in 2019, researchers found that nearly 100 million (11.8%) would have reduced out-of-pocket spending for patients if they had been acquired through the billionaire-backed manufacturer and distributor.”