Happy Groundhog Day

Telehealth

Happy Groundhog Day

David Ermer–CDC, CMS, Congress, COVID-19, FDA, NIH, Telehealth, U.S. Healthcare–

From Gobbler’s Notch, PA, NPR informs us,

  • “Punxsutawney Phil, the renowned groundhog who’s been predicting when winter will end since 1887, says things are about to warm up.
  • “Glad tidings on this Groundhog Day. An early spring is on the way,” a proclamation was read out at Gobbler’s Knob, elating a crowd of thousands of people who had weathered dark and cold to see the famous rodent.”

From Washington, DC

  • Rep. James Comer, the Chair of the House of Representatives Oversight and Accountability Committee announced that the full Committee will be marking up several bills next Tuesday at 10 am, including
    • “H.R. 6283, the Delinking Revenue from Unfair Gouging Act: Adds a new section to the Federal Employees Health Benefits Act which would make changes to Pharmacy Benefit Manager (PBM) pricing, including implementing de-linking policies and requiring a PBM to only charge a flat fee for drug placement versus letting them continue to charge a percentage of the drug.”
    • The markup will be open to the public and press [at 2154 Rayburn House Office Building”] and will be live streamed online at https://oversight.house.gov/.
  • Govexec tells us,
    • “The federal government added 11,000 jobs in January, an usually high number but in line with recent trends under the Biden administration. 
    • “Including the U.S. Postal Service, federal agencies have seen robust growth of 86,000 jobs over the last year. Not counting decennial census years when the government hires hundreds of thousands of temporary workers, total federal employment reached its highest level in at least 20 years, according to Bureau of Labor Statistics data. The last year saw the most non-census hiring of any 12-month period over the same two-decade period. 
    • “Of the 11,000 jobs gained in January, about 4,500 were for the Postal Service and 6,500 went toward the rest of federal government. Only a handful of non-census months over the last 20 years have seen such significant federal job growth. Federal employment has increased in 16 of the last 17 months.” 
  • mHealth Intelligence points out,
    • “The Department of Health and Human Services (HHS) published a final rule on February 2 that significantly expands access to medications for opioid use disorder (OUD), including allowing treatment initiation through telehealth.”The Department of Health and Human Services (HHS) will publish a final rule on February 2 that significantly expands access to medications for opioid use disorder (OUD), including allowing treatment initiation through telehealth.
    • “This final rule updates certain provisions of regulations related to Opioid Treatment Program (OTP) accreditation, certification, and standards for treating OUD with medications. These are the first substantial changes to the rules governing OTPs in 20 years.”
  • Healthcare Finance delves into the 2025 Advance Notice for the Medicare Advantage and Medicare Part D Prescription Drug Programs released Wednesday.
  • The Affordable Care Act regulators issued ACA Frequently Asked Question 65 which seeks to resolve a Transparency in Coverage compliance issue.
  • “On Thursday, the FDA advised consumers in the Don’t Overuse Acetaminophen Consumer Update to be cautious not to exceed the daily maximum recommended dose of acetaminophen, which can lead to overdose and severe liver damage. Over 600 medications – both prescription and nonprescription – have acetaminophen to help relieve pain and reduce fever.”
  • The Hill reports that Perigo expects to have its Opill over the counter female contraceptive pills on pharmacy shelves in the first quarter of 2024. Perigo has not accounced Opill’s retail price, “with a spokesperson saying it is committed to making sure its product is ‘accessible to people who need it.'”

From the U.S. public health and medical research front,

  • The University of Minnesota’s CIDRAP reports,
    • “After declining trends over the past few weeks, flu activity rose in some parts of the country, while COVID-19 and respiratory syncytial virus (RSV) levels continued overall declines, according to the latest updates today from the US Centers for Disease Control and Prevention (CDC).
    • “Though flu indicators declined following the winter holidays, the CDC has said that it is watching for a second peak that sometimes occurs after the winter holidays. In its respiratory virus snapshot, the CDC said some regions are seeing rising flu indicators, especially in the Midwest and South-Central regions.
    • “Also, the percentage of respiratory samples that were positive for flu at clinical labs rose last week to 16.2%, compared to 14.2% the previous week, the CDC said in its weekly flu update. Influenza A is still dominant, with 60.4% of subtyped samples belonging to the 2009 H1N1 subtype. There were increases in the percentages of H3N2 and influenza B detections compared to the previous week.
    • “Outpatient visits for flulike illness held steady and have been above the national baseline since November. However, CDC surveillance shows a rise for one age-group: people ages 5 to 24 years.”
  • The Center for Disease Control adds,
    • “According to insurance claims data for adults 18 years and older, as of January 13, 2024, the number of flu vaccination doses given so far this season in pharmacies and medical offices is lower compared with last season by about 7 million doses (from 66 million to 59 million doses, or about a 10% percent decline). There were drops in the number of doses given in both pharmacies and medical offices this season compared with last season.”
  • The National Institutes of Health’s Director explains in her blog why “Findings in Tuberculosis Immunity Point Toward New Approaches to Treatment and Prevention.”
  • Precision Vaccinations discusses why HIV vaccine development is rekindling in 2024.
  • Mercer Consulting lets us know,
    • “Black Americans represent approximately 12% of the U.S. population but account for 40% of people with HIV. The rate of new HIV infections among Black women is 10 times that of white women and four times that of Latina women. While HIV can affect anyone regardless of sexual orientation, race, ethnicity, gender, age, or where they live, some population groups have higher rates of HIV in their communities, thus raising the risk of new infections.  
    • “Black communities have made great progress in reducing HIV. Yet racism, discrimination, and mistrust in the health care system may affect whether Black people seek or receive HIV prevention services. These issues may also reduce the likelihood of engaging in HIV treatment and care.
    • “National Black HIV AIDS Awareness Day on February 7 is an opportunity to increase HIV education, testing, community involvement, and treatment among Black communities. We encourage employers to use this as a call to action to educate your workforce about HIV, to reduce stigma and create workplaces where everyone feels they belong, as well as help make employees aware of the HIV prevention and treatment resources available to them.”
  • Fierce Healthcare adds,
    • “There are significant health disparities among people with employer coverage, but plan sponsors still have work to do to fully address those issues, according to a new analysis.
    • “The report comes from Morgan Health, the healthcare arm of banking giant JPMorgan Chase. It identifies some critical disparities in the employer-sponsored sector and suggests strategies employer can use to tackle these challenges.
  • NPR interviews an anatomy professor who explains why a person’s appendix is useful.
    • “It turns out that the appendix appears to have two related functions. The first function is supporting the immune system. The appendix has a high concentration of immune tissue, so it’s acting to help the immune system fight any bad things in the gut. 
    • “The second function that it serves is what we refer to as the safe house. So this was a hypothesis that was put forward by a team from Duke University in 2007. And they argued that the appendix may serve as a safe reservoir for the beneficial gut bacteria that we have.” 

From the U.S. healthcare business front,

  • Beckers Payer Issues reports,
    • “The Cigna Group is projecting $235 billion in revenue by the end of 2024 and recorded double-digit growth in the fourth quarter across its core lines of business at Evernorth Health Services and Cigna Healthcare, according to the company’s year-end earnings report published Feb. 2.
    • “Total revenues in the fourth quarter were $51.1 billion, up 12% year over year. Total revenues in 2023 were $195.3 billion, up 8%.
    • “In the fourth quarter, net income was more than $1 billion, down 14% from nearly $1.2 billion year over year. Year-end net income was nearly $5.2 billion, down 23% year over year. 
    • “Evernorth revenues rose 12% year over year to $40.5 billion in the fourth quarter. Operational earnings in the fourth quarter were nearly $1.5 billion, and $4.8 billion in 2023.
    • “The insurance side of the business, Cigna Healthcare, reported fourth-quarter revenues of nearly $13 billion, up 16% from the previous year. Operational income in the fourth quarter was $925 million, and $4.2 billion in 2023.
    • “The company’s medical loss ratio was 82.2% in the fourth quarter, compared to 83.8% during the same period last year. In 2023, the company’s MLR was 81.3%.”
  • Healthcare Dive adds,
    • “Cigna on Friday defended its decision to sell its Medicare division, with management telling investors the health insurer will emerge from the divestiture as a leaner and more focused organization.
    • “On a call to discuss Cigna’s fourth-quarter earnings, analysts peppered the payer’s C-suite with questions about the trajectory of its business following the sale, which some had criticized for seeming to undervalue Cigna’s Medicare lives.
    • “Cigna still likes Medicare as an expansion area, but is more interested in providing services like pharmacy benefits to other Medicare Advantage organizations than offering plans itself, according to CEO David Cordani. “We were really pleased with the nature of the transaction we were able to structure,” Cordani said on the call. ”We see it as a win-win.”
  • Per Fierce Healthcare,
    • “When Florida Blue announced this week that it’s partnering with Sanitas Medical Center in Jacksonville to deliver primary care, officials with the company considered it in keeping with a healthcare system that’s evolving from one based on volume to one based on value.
    • “The healthcare system has largely been fee-for-service,” Elana Schrader, M.D., senior vice president of Florida Blue healthcare services and president of sister company GuideWell Health, told Fierce Healthcare. “Now, we’re talking about paying for services that help us achieve better outcomes. It’s a whole new value equation. Value-based care has been around, but it’s growing and growing.
    • “She added that in the future the health plan hopes that most, if not all, of the care provided will be based on value not volume. The umbrella of what can be described as primary care at the Jacksonville center is a large one under which resides, according to a press release, “preventive and primary care, onsite pharmacy dispensing, chronic condition management, mental health services, labs and imaging, and a community use space for patient and community education and social engagement and wellness classes and activities.”
  • and
    • “Optum Perks is rolling out a new telehealth solution that aims to make it easier for patients to secure their prescriptions at a low cost.
    • “Optum Perks is a part of the RVO Health umbrella, which is jointly backed by Red Ventures and UnitedHealth Group’s Optum. Its sister, Optum Store, is also within RVO Health. Optum Perks offers prescription discounts to consumers and is building on that foundation through the new virtual platform.
    • “Users can access care on demand starting at $25 for hundreds of conditions and needs including acne, birth control, cold and flu, high blood pressure and more. It services are available for people with or without insurance.”
  • Per Healthcare Dive,
    • “Telehealth availability for mental healthcare varies widely from state to state, suggesting some patients may face “several hurdles” when booking appointments for services, according to a study published Friday in JAMA Health Forum.
    • “The analysis, conducted by nonprofit research institute Rand Corporation, found less than half of mental health treatment facilities in Mississippi and South Carolina offered telehealth care, while all facilities contacted in Delaware, Maine, New Mexico and Oregon did. Researchers were also unable to reach one in five facilities when attempting to inquire about telehealth options, the study found.” 
  • Beckers Hospital Review lists emergency department visit times by state.
    • “Patients in Washington, D.C., had the highest median time spent in the emergency department, while patients in North Dakota had the lowest, CMS data shows.
    • “The agency’s “Timely and Effective Care” dataset, updated Jan. 31, tracks the average median time patients spend in the emergency department before leaving. The measures apply to children and adults treated at hospitals paid under the Inpatient Prospective Payment System or the Outpatient Prospective Payment System, as well as those that voluntarily report data on relevant measures for Medicare patients, Medicare managed care patients and non-Medicare patients. 
    • “Data was collected from April 2022 through March 2023. Averages include data for Veterans Health Administration and Department of Defense hospitals. Learn more about the methodology here.
    • “Nationwide, the median time patients spent in the ED was 162 minutes, up from 159 minutes in the 12-month period ending in March 2022, according to CMS data. In the same period ending in 2021, this figure sat at 149 minutes.”

Tuesday Tidbits

David Ermer–ACA, AHRQ, Congress, FDA, Federal employment benefits, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • Senator Chuck Grassley (R Iowa) announced that he and
    • Maria Cantwell (D-Wash.) are leading 12 of their colleagues in urging the Federal Trade Commission (FTC) to complete its investigation into the health care industry’s most powerful prescription drug middlemen. The bipartisan senators are also requesting a status update on the investigation, which has now been open for over 18 months.
    • “We support the [FTC’s] issuance of a Section 6(b) order and conducting a timely study of pharmacy benefits managers’ (PBM) business practices,” the senators wrote in their letter to FTC Chair Lina Khan. “With the FTC’s inquiry reaching its year-and-a-half mark, we urge the FTC to complete the study without delay. In the interim, we believe it is important to know the status of the study and therefore ask the FTC to issue a progress report.”  ***
    • Read the full letter HERE.
  • The Department of Health and Human Services informs us,
    • “On January 12th, U.S. Secretary of Health Xavier Becerra spoke with Canadian Health Minister Mark Holland regarding the recent announcement on commercial drug importation from Canada by U.S. states. During the call, they agreed to continue to discuss mechanisms and strategize on finding solutions to combat increasing drug prices to ensure that both Americans and Canadians have access to an affordable and stable drug supply.  Secretary Becerra and Minister Holland committed to keeping in close contact to ensure a mutually beneficial path forward.”
  • and
    • “On Monday, January 22, HHS and Pfizer leadership met virtually with health care provider groups, including the American Medical Association, American Academy of Family Physicians, and others – highlighting the pathways for a smooth transition of oral antivirals for COVID-19, including Paxlovid, to the commercial market and the importance of provider education and clear communication to consumers.
    • “During the call, HHS leadership reminded providers that no patient should be forced to pay the full out-of-pocket cost to access Paxlovid, regardless of their insurance status. Providers should take steps to ensure patients understand the full range of options when it comes to accessing these life-saving treatments and anyone who is facing difficulties at the pharmacy counter should be directed to the PAXCESS patient assistance program (PAP).”
  • Federal Manager tells us,
    • “The results from the fiscal year (FY) 2023 Human Capital Reviews show that Chief Human Capital Officers (CHCOs) want more resources, are making strides in implementing diversity, equity, inclusion, and accessibility (DEIA), and plan to use data more heavily in the future.
    • “The annual reviews probed CHCOs opinions in four areas: Workforce planning and analysis, Implementation of Executive Order 14035 (Advancing Diversity, Equity, Inclusion, and Accessibility), evaluation of system development, and innovation.”
  • Reg Jones, writing in FedWeek, discusses 2024 FEHB premiums and coverage.
  • BioPharma Dive points out,
    • “The makers of CAR-T cell therapies will need to warn about the risk of new blood cancer, the Food and Drug Administration said, following a review of reports involving so-called T cell malignancies following their use.
    • “In Jan. 19 letters to the manufacturers of six CAR-T therapies, the FDA said the prescribing information will need to include boxed warnings, the strongest type. In communication with industry executives, FDA officials have said they believe the benefits of these treatments, which are approved for types of lymphoma, leukemia and multiple myeloma, outweigh their risks.
    • “Since the FDA’s review began in late November, academic researchers have been probing the issue, too. One cell therapy advocacy group noted how the rate of 20 cases of T cell malignancies in roughly 34,000 CAR-T treated patients “is notably lower than that reported for more conventional alternative treatments.” The organization called for more studies to determine if some patients are at higher risk than others.”
  • The U.S. Preventive Services Task Force “concluded that the current evidence is insufficient to assess the balance of benefits and harms of screening for speech and language delay and disorders in children 5 years or younger.” The USPSTF previously gave the same recommendation to this service in 2015.

From the public health and medical research front,

  • Phrma, the drug manufacturer trade association, announced,
    • “2023 marked a five-year high for the number of new treatments and vaccines developed by the biopharmaceutical industry and approved by the U.S. Food and Drug Administration (FDA). According to new information from the FDA’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), 71 novel treatments and vaccines were approved last year for people facing various cancers, certain rare diseases and more. Each new treatment represents new hope and progress for patients and their loved ones.”
  • CNN reports,
    • “Testing a person’s blood for a type of protein called phosphorylated tau, or p-tau, could be used to screen for Alzheimer’s disease with “high accuracy,” even before symptoms begin to show, a new study suggests.
    • “The study involved testing blood for a key biomarker of Alzheimer’s called p-tau217, which increases at the same time as other damaging proteins — beta amyloid and tau — build up in the brains of people with the disease. Currently, to identify the buildup of beta amyloid and tau in the brain, patients undergo a brain scan or spinal tap, which often can be inaccessible and costly.
    • “But this simple blood test was found to be up to 96% accurate in identifying elevated levels of beta amyloid and up to 97% accurate in identifying tau, according to the study published Monday in the journal JAMA Neurology.
    • “What was impressive with these results is that the blood test was just as accurate as advanced testing like cerebrospinal fluid tests and brain scans at showing Alzheimer’s disease pathology in the brain,” Nicholas Ashton, a professor of neurochemistry at the University of Gothenburg in Sweden and one of the study’s lead authors, said in an email.”
  • The Washington Post adds, “For some Alzheimer’s patients, vision problems may be an early warning. A large study brings fresh attention to a lesser-known variant of the disease called posterior cortical atrophy.”
  • The AP reports,
    • “New York City intends to wipe out more than $2 billion in medical debt for up to 500,000 residents, tackling a top cause of personal bankruptcy, Mayor Eric Adams announced Monday.
    • The city is working with RIP Medical Debt, a nonprofit that buys medical debt in bulk from hospitals and debt collectors for pennies on the dollar. The group targets the debt of people with low incomes or financial hardships and then forgives the amounts.
    • Under the program, the city will spend $18 million over three years.”

From the U.S. health care business front,

  • Beckers Hospital Review shares the latest HeathGrades top hospital lists.
    • “Healthgrades has recognized 250 hospitals nationwide for exceptional care via its “America’s Best Hospitals” awards, released Jan. 23.
    • “Three lists feature America’s 50, 100 and 250 best hospitals, which represent the top 1 percent, 2 percent and 5 percent of hospitals in the nation, respectively.”
  • STAT News reports,
    • “Steward Health Care, a for-profit health system that serves thousands of patients in Eastern Massachusetts, is in such grave financial distress that it may be unable to continue operating some facilities, according to public records and people with knowledge of the situation. The fast-moving crisis has left regulators racing to prevent the massive layoffs and erosion of care that could come if hospital services were to suddenly cease.
    • “Steward runs nine Massachusetts hospitals, mostly in Boston suburbs and underserved cities from the Merrimack Valley to the South Coast. But the national operator has shown escalating financial difficulties for at least the past three years, according to public records. This month, Steward’s landlord revealed in a news release that the health system hadn’t been paying its full rent for months and would contemplate selling off hospitals nationally.”
  • Healthcare Dive adds,
    • “Hospital Sisters Health System will close two hospitals and some health centers in Western Wisconsin following prolonged financial stress, the nonprofit system said Monday.
    • “HSHS will close St. Joseph’s Hospital and Sacred Heart Hospital around the end of the first quarter this year. The system also plans to close all the medical centers it operates in the region in partnership with multispecialty group Prevea Health by April 21, according to a release.
    • “The closures, which will impact roughly 1,400 HSHS and Prevea employees, will fully exit the faith-based heath system from the Western Wisconsin region.”
  • BioPharma Dive lets us know,
    • “Sanofi on Tuesday said it will acquire San Diego biotechnology company Inhibrx in a complex deal that could be worth up to $2.2 billion.
    • “The focus of the deal is an experimental drug Inhibrx is developing for a rare lung disease known as alpha-1 antitrypsin deficiency. Sanofi will acquire the drug via a buyout of Inhibrx following the spinout of the biotech’s other assets and employees into a new publicly traded company that will inherit the Inhibrx name.”
  • MedTech Dive notes that “Orthopedics leaders watch procedure backlog, new technologies in 2024. J&J, Medtronic and Smith & Nephew executives and orthopedic surgeons said they expect more procedures to move outpatient, while questions about pricing and procedure backlogs loom over the space.”
  • Per Beckers Hospital Review,
    • “Optum Perks, a prescription discount provider, has launched a new telehealth service that provides affordable healthcare and prescription treatments for conditions such as acne, cough and high blood pressure.
    • “The new service, with a starting cost of $25, allows patients to receive care at any time and can give them access to birth control, cold or flu medication and medication refills, without the need for scheduling or video chat, according to a Jan. 23 news release from Optum Perks. Optum Perks is part of RVO Health, a joint venture between Optum and Red Ventures.” 
  • Per Fierce Healthcare,
    • “Bitewell, a food-as-medicine company, has launched a new digital food “farmacy” to encourage members to buy healthy groceries and pre-made meals.
    • “The online store personalizes the food shopping experience based on members’ health conditions and goals. Members can access the offering through a participating health plan, wellness program or provider.
    • “Kelly’s Choice, a nutrition and health platform offering coaching and workplace wellness, is among the partners who will begin sponsoring Bitewell food farmacy memberships this month.”

Tuesday Tidbits

David Ermer–AHRQ, Congress, FDA, Mental health care, NIH, No Surprises Act, Obesity, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • Roll Call tells us,
    • “The Senate overwhelmingly voted Tuesday night in favor of the first procedural move needed to avert a partial government shutdown at the end of this week.
    • “The chamber voted 68-13 to end debate on the motion to proceed to the shell legislative vehicle for the stopgap spending measure, which would run to March 1 for four of the dozen annual appropriations bills and until March 8 for the remaining eight.
    • “Leadership in both chambers are in favor of the stopgap measure, which is designed to give appropriators more time to negotiate final fiscal 2024 appropriations bills following the $1.66 trillion topline agreement Speaker Mike Johnson, R-La., and Senate Majority Leader Charles E. Schumer, D-N.Y., announced earlier this month.”
  • Roll Call further informs us,
    • “Congressional leaders and key committee heads are poised to meet with the president at the White House Wednesday to discuss the national security supplemental package that has remained stalled over the lack of agreement on border and immigration policy measures.
    • “White House Press Secretary Karine Jean-Pierre confirmed President Joe Biden’s plans to host the meeting during a Tuesday briefing. 
    • “Speaker Mike Johnson, R-La., House Minority Leader Hakeem Jeffries, D-N.Y., Senate Majority Leader Charles E. Schumer, D-N.Y., and Senate Minority Leader Mitch McConnell, R-Ky., are expected to attend the meeting.”
  • The Wall Street Journal adds,
    • “Top U.S. lawmakers unveiled a bipartisan tax agreement that would revive expired breaks for businesses and increase the child tax credit for low-income families, and they are aiming to push the $78 billion in tax breaks through Congress in the next few weeks. 
    • “The deal comes from Sen. Ron Wyden (D., Ore.) and Rep. Jason Smith (R., Mo.), ideological opponents who found common ground after months of talks. They have a tough task ahead, given skepticism about aspects of the deal in both parties and a tight deadline before tax season starts.”
  • Roll Call notes,
    • “The conservative-controlled Supreme Court could upend how courts handle challenges to the decisions administrative agencies make, in a pair of cases set for oral arguments Wednesday that could change the standards for how Congress writes laws and the federal government implements them.
    • “The challengers to a fishery inspection rule asked the justices to overturn the Chevron doctrine, a nearly 40-year-old legal framework based on a Supreme Court decision that established that judges should defer to the agencies’ interpretations of a law when that law is ambiguous.
    • “Parts of the conservative legal movement have targeted the doctrine for years, casting it as emblematic of the broader power of administrative agencies, and Wednesday’s oral arguments could preview its demise.”
  • STAT News reports,
    • “President Biden has promised to require fair prices from drugmakers that use federally funded research — and now, in a major recent move, said he’ll trigger government “march-in” on patents for drugs that run afoul of that goal.
    • “It’s a simple principle. You shouldn’t pay the highest price in the world for drugs that your tax dollars have already helped create,” Biden said last month as he touted the move at the National Institutes of Health.
    • “But the new NIH director, locked in the center of this debate, isn’t taking any big steps yet.
    • “Our relationship with the pharmaceutical industry, with the industry overall, is really, really critical,” Director Monica Bertagnolli told STAT in an interview. “It’s very difficult, if you can imagine, to implement something broadly that is as effective as we want it to be.”
  • KFF Health News reports that a new federal program to save rural hospitals is experiencing growing pains.
  • The U.S. Preventive Services Task Force announced the appointment of three new members, “Sei Lee, M.D., M.A.S.; Tonette Krousel-Wood, M.D., M.S.P.H.; and Sarah Wiehe, M.D., M.P.H. They are appointed to serve 4-year terms beginning in January 2024.”
  • The National Academies of Science announced,
    • “A new report from the National Academies of Sciences, Engineering, and Medicine says 15 health care services related to intimate partner violence — including reproductive health care, screening for STIs and HIV, forensic medical exams, and mental health care — should be classified by the Health Resources and Services Administration and all U.S. health care systems as essential healthcare services. The report recommends prioritizing access to these healthcare services during public health emergencies, such as a pandemic or natural disasters, using a phased approach.”  
  • Per Forbes,
    • “The FDA approved the use of Casgevy, a therapy that uses CRISPR gene-editing to treat the serious blood disorder transfusion-dependent beta-thalassemia, marking the second major U.S. regulatory approval for the emerging gene-editing technology. The FDA’s approval comes just one month after the regulator approved the use of Casgevy in treating sickle cell disease.”

From the public health and medical research front,

  • Health Day points out,
    • “Despite overall progress against cancer in the United States, Black Americans are still more prone to die of the disease than whites
    • “Data from 2000 to 2020 showed the racial gap in cancer deaths had diminished but was still significant.
    • “Disparities in deaths from breast cancer, prostate cancer and colon cancer in men were especially troubling.”
  • Healthcare IT News explains why “Virtual group therapy enables Geisinger to treat more patients and maintain care continuity. With waits for individual psychotherapy as long as several months and several thousand outstanding orders, the mostly rural health system needed a solution. Combining group therapy and telemedicine [with help from American Well] was the answer.”
  • STAT News reports,
    • “Last fall, the World Health Organization and some national drug regulators urged influenza vaccine manufacturers to drop the component known as B/Yamagata from flu vaccines as quickly as possible, citing the fact that this lineage of flu B viruses appears to have been snuffed out during the Covid-19 pandemic.
    • “It might seem like that request would be as simple as deciding to leave blueberries out of a mixed-fruit smoothie. It turns out it is not.”

From the U.S. healthcare business front,

  • Healthcare Dive discusses trends shaping the health insurance business in 2024.
  • Via Fierce Healthcare, Morgan Health offers three items employers should focus on to manage GLP-1 drug costs.
  • Bloomberg informs us about lawsuits that air ambulance companies have brought against health insurers who allegedly refused to pay No Surprises Act arbitration awards. The insurers have asked the federal district court in Houston to dismiss the cases for lack of subject matter jurisdiction and improper venue.
  • Beckers Hospital Review lets us know,
    • “The Mayo Clinic Diet, a weight loss program developed by the Rochester, Minn.-based health system, is launching a weight loss telemedicine service.
    • “The Mayo Clinic Diet Medical Weight Loss Rx program will offer direct access to weight loss medications, or GLP-1s, via video visits with Amwell Medical Group clinicians, according to a Jan. 16 news release shared with Becker’s.
    • “The program, which is available in beta form to qualifying members, will also provide lab testing to confirm medication suitability, clinical monitoring, insurance support, meal plan options, and coaching and education tools.”
  • Beckers Payer Issues tells us,
    • “Though some contract negotiations with providers came “down to the wire” last year, UnitedHealthcare executives said the payer did not see more contract splits than usual in 2023. 
    • “Brian Thompson, CEO of UnitedHealthcare, told investors on a Jan. 12 call the insurer did not see more contract disruptions than in previous years in 2023.” 

 

Monday Roundup

David Ermer–Congress, Medical / Rx research, Mental health care, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington DC,

  • Roll Call reports, “As the calendar turns to a presidential election year with control of both chambers in play, Congress and the White House are facing a full slate of leftovers from 2023, headlined by a stalled emergency supplemental spending request and looming deadlines to keep the government open.”
  • The Wall Street Journal adds,
    • “House Speaker Mike Johnson (R., La.) now has less than two weeks to pass spending legislation needed to avert a partial government shutdown, while contending with many of the same challenges that ultimately took down his predecessor three months ago.
    • “Following a deal with the Democratic-led Senate announced over the weekend, Johnson will try to rally his fellow Republicans this week around a plan for $1.66 trillion in overall discretionary spending for fiscal 2024.   
    • “While Democrats have largely signaled their support for the agreement, hard-line conservatives have blasted the top-line figure, meaning that Johnson almost certainly will have to rely on Democratic votes to pass the measure in the House, where the GOP has a narrow 220-213 majority. Former speaker Kevin McCarthy (R., Calif.) was able to muscle through a short-term spending bill in September and avert a government shutdown, only for eight Republican rebels to then engineer his ouster.
    • “Johnson noted Sunday that he now has an even smaller majority than when McCarthy was the speaker. “We deal with the numbers that we have,” Johnson said on  CBS. “It will be one of the smallest majorities in the history of the Congress, clearly.”
    • “The speaker backed a short-term deal late last year to avoid a Christmas showdown over spending. New deadlines of Jan. 19 and Feb. 2 are now before him, providing the biggest test of his still-fledgling speakership and his ability to wrangle his unruly GOP conference.”
  • Good luck, Mr. Speaker.
  • The American Hospital Association News tells us,
    • “Health and Human Services Secretary Xavier Becerra Jan. 8 appointed as chief competition officer Stacy Sanders, who currently oversees the department’s implementation of the Inflation Reduction Act, long-term care initiatives, policies to promote health care competition and other Medicare work. In this new role, announced by the Biden Administration last month, Sanders will work with the Federal Trade Commission and Department of Justice to address concentration in healthcare markets through data-sharing, reciprocal training programs, and other policy initiatives.”

From the public health and medical research front,

  • Endpoint News informs us,
    • “The crown jewel from Bayer’s 2020 buyout of women’s health biotech KaNDy Therapeutics has proven its worth in the clinic, meeting all primary and secondary endpoints in a pair of Phase III studies.
    • “Bayer says it plans to file the drug, elinzanetant, for regulatory approvals to treat moderate to severe vasomotor symptoms associated with menopause once results from a third Phase III study are in. Those data are expected within the next few months.
    • “Elinzanetant, formerly known as NT-814, hit all four primary endpoints in the OASIS 1 and 2 studies, showing statistically significant reductions in the frequency and severity of VMS symptoms — also known as hot flashes. The company didn’t report any numbers, but it said the drug also did better than placebo on a slate of secondary endpoints, including frequency of VMS at week 1, improvement of sleep disturbance and menopause-related quality of life.”
  • The Institute for Clinical and Economic Review (ICER) released a Final Evidence Report on Treatment for Pulmonary Arterial Hypertension.
    • ICER’s “Independent appraisal committee voted that sotatercept demonstrated a net health benefit when compared to background therapy; sotatercept would achieve common thresholds for cost-effectiveness if priced between $17,900 to $35,400 per year.
  • The Washington Post and Consumer Reports points out “quick fixes for congestion, sneezing and other sinus woes.”

From the U.S. healthcare business front,

  • The National Institutes of Health announced,
    • “Access to residential addiction treatment centers caring for U.S. adolescents under 18 years old in the United States is limited and costly, according to a new study(link is external) supported by the National Institutes of Health. Researchers found that only about half (54%) of the residential addiction treatment facilities that they contacted had a bed immediately available, and for those that had a waitlist, the average estimated time before a bed opened was 28 days. In addition, the average daily cost per day of treatment was $878, with close to half (48%) of the facilities that provided information requiring partial or full payment upfront. On average, the quoted cost of a month’s stay at a residential addiction treatment facility was over $26,000.
    • “Published in Health Affairs, this study was supported by the National Institute on Drug Abuse (NIDA) and the National Center for Advancing Translational Sciences (NCATS), both part of NIH, and led by researchers at Oregon Health & Science University (OHSU). The results build on previous research revealing that only one in four residential treatment centers caring for U.S. adolescents under 18 years old provide buprenorphine, a medication to treat opioid use disorder.
    • “The ability to access timely, evidence-based treatment for addiction can be a matter of life or death, and the current system too often fails young people,” said Nora Volkow, M.D., director of NIDA. “We need to make access to timely, affordable, and evidence-based care the norm across treatment settings.”
  • mHealth Intelligence takes a look at this year’s virtual care trends.
    • “The mood of healthcare stakeholders going into 2024 may be more somber than in the recent past, but the work of integrating virtual care into the US healthcare system is ongoing. Here [in the article] are some key trends healthcare leaders, policy experts, and consultants expect to see in the new year.”
  • MedTech Dive notes,
    • “Procedure volumes increased in the fourth quarter, mostly matching or exceeding the usual seasonal trend, according to Truist Securities’ survey of 50 U.S. hospital administrators.
    • “The survey suggests procedure volumes rose 2% to 3% over the third quarter, with interventional cardiology experiencing the biggest increase. The analysts wrote companies including Boston Scientific, Edwards Lifesciences and Medtronic would benefit from rising cardiology volumes.
    • “Truist also saw positive signs for Intuitive Surgical, tracking improvements in the outlook for capital spending and a rebound in weight loss procedures after pressure from obesity drugs.”
  • and
    • “Boston Scientific said Monday it has agreed to acquire Axonics, maker of devices to treat urinary and bowel dysfunction, for $3.7 billion in cash, or $71 per share.
    • “The acquisition allows Boston Scientific to enter the high-growth sacral neuromodulation market, where it will compete with companies such as Medtronic. 
    • “Stifel analyst Rick Wise, in a note to clients Monday, called the deal a highly complementary fit to Boston Scientific’s urology business, which generated about 14% of its estimated 2023 sales.”

Tuesday Tidbits

David Ermer–FDA, Federal employment benefits, Generative AI, Medical / Rx research, Mental health care, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The U.S. Census Bureau informs us,
    • “[T]he U.S. population [was projected to be] 335,893,238 on New Year’s Day, an annual increase of 1,759,535 or 0.53%.
    • “In January 2024, the United States is expected to experience a birth every 9.0 seconds and one death every 9.5 seconds. Meanwhile, net international migration is expected to add one person to the U.S. population every 28.3 seconds. The combination of births, deaths and net international migration increases the U.S. population by one person every 24.2 seconds.
    • “The projected world population on Jan. 1, 2024, is 8,019,876,189, up 75,162,541 (0.95%) from New Year’s Day 2023. During January 2024, 4.3 births and 2.0 deaths are expected worldwide every second.”
  • The Internal Revenue Service released the Employers’ Tax Guide to Fringe Benefits for use in 2024.
  • Federal News Network discusses four ways federal pay practices have changed for 2024.
  • The Food and Drug Administration accounts for its recent actions.

From the public health and medical research front,

  • Medscape explains the other health conditions, besides diabetes and obesity, that GLP-1 drugs might treat. It’s an impressive list.
  • STAT News reports,
    • “Reducing or eliminating alcohol consumption reduces the risk of developing oral cavity and esophagus cancers, according to a special report from the International Agency for Research on Cancer. But more data are needed to conclude whether the same is true for several other cancer types, including colorectal, breast, and liver cancer.
    • “Even so, it is likely that reducing or ceasing to drink alcohol will lessen the risk of these cancers, said Farhad Islami, a cancer epidemiologist at the American Cancer Society and an author of the report. “Given that many of these cancers have similar mechanistic pathways, we think we will see a similar association with reduction or cessation,” he said. “That’s why we recommend more studies, so we can have stronger evidence.”
  • BioPharma Dive points out ten clinical trials that are worth watching in the first half of 2024.

From the U.S. healthcare business front,

  • Healthcare Dive tells us,
    • “BJC HealthCare and Saint Luke’s Health System closed their merger on Monday, about seven months after the Missouri-based systems announced plans to combine.The combined organization will operate under the BJC HealthCare brand in its eastern region, serving St. Louis and southern Illinois. The Kansas City region will retain the Saint Luke’s brand name. The new system has a combined workforce of 44,000 employees, according to a Tuesday announcement.”
  • MedTech Dive notes,
    • “Roche reached an agreement to acquire LumiraDx’s point-of-care testing technology, the companies announced on Dec. 29.
    • “Roche will pay $295 million upfront and an additional amount up to $55 million to fund Lumira’s point-of-care technology platform business until the acquisition closes. 
    • “The acquisition comes as Lumira faces a potential delisting amid declining revenue.”
  • Health Payer Intelligence identifies trends in health insurer strategies for 2024. “In 2024, payer strategies will include improving health equity partnerships, differentiating their Medicare Advantage plans, and offering care navigation.”
  • Healthcare IT News offers an interview with “[t]wo investment bankers discuss the players in the telehealth sector, the main financial backers, the dynamics between venture capital and private equity, and more.
  • Beckers Hospital Review tells us,
    • “Feeling blue? Your employer might have an AI app for that, The Wall Street Journal reported Dec. 27. 
    • “Workplaces increasingly are offering employees access to digital mental health tools, including AI chatbots meant to mimic therapists and wellness apps that diagnose mental health conditions, the report said. Over the summer, a survey of 457 U.S. companies conducted by professional services company WTW found that about one-third offer a “digital therapeutic” for mental health support. Another 15% were considering adding one by 2025. 
    • “The capabilities and goals of these services vary. Amazon gives employees free access to the app Twill, which uses AI to track users’ moods and create “personalized mental-health plan(s).” A construction workers’ union in Ohio will begin offering access to Wysa, a self-described “emotionally intelligent” AI chatbot that encourages users to “vent or just talk through negative thoughts and emotions” and “let it help you cope with pandemic anxiety and lockdowns.” 

Monday Roundup

David Ermer–Congress, Generative AI, Medical / Rx research, No Surprises Act, SDOH, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • The New York Times reports,
    • “The prospects for passing legislation to speed military aid to Ukraine this year are fading, as Republicans balk at striking a quick deal on immigration policy changes they have demanded in exchange for allowing the bill to move forward.
    • “After a weekend of intensive bipartisan border talks yielded progress but no breakthrough, Senator Chuck Schumer, Democrat of New York and the majority leader, acknowledged on Monday that negotiators were still far from completing a deal.
    • “It’s going to take some more time to get it done,” he said on the Senate floor on Monday afternoon, laying out plans for the week that made no mention of any votes on the aid package for Ukraine.”
  • Govexec tells us that “The Senate on Monday voted 50-11 to confirm former Maryland Gov. Martin O’Malley as commissioner of the Social Security Administration, ending a drought of more than two years in which the embattled agency lacked a permanent leader at the helm.”
  • Fierce Healthcare informs us,
    • “The Biden administration on Monday released amended fees related to independent dispute resolution under the No Surprises Act.
    • “In the amended final rule, CMS said it will instead set an administrative fee of $115 for disputes that are subject to the rule. A separate rule, which is up for comment until Jan. 2, adjusts the fees for disputes initiated after Jan. 1, 2025. * * *
    • “In addition, CMS outlined ranges for certified IDR entity fees, which the arbiters charge for determinations. Under the rule, the agency finalized a range of between $200 and $840 for a single determination and between $268 and $1,173 for batch rulings.
    • “These fees are also set annually, and IDRs can request to update them once each year, which the feds must approve.”
    • The rule takes effect on January 20, 2023.

From the public health and medical research front,

  • STAT News points out,
    • “As more data emerges that obesity drugs like Wegovy can reduce complications from heart and kidney problems as well, scientists have been wondering whether these benefits are driven by weight loss alone or also by other mechanisms.
    • “A new study suggests that one possible contributor is the drugs’ ability to reduce inflammation independent of weight loss.
    • “In mice experiments, scientists found that the treatments, known as GLP-1-based drugs, acted through the brain to reduce inflammation throughout the body. This was over a short period of time before the mice lost weight, according to the study, published Monday in Cell Metabolism.
    • “Though the researchers only studied mice, and didn’t look at how much the reduced inflammation translates to actual health benefits, they detailed a previously unknown mechanism of GLP-1 drugs that may help explain their effects on organs throughout the body.
    • “This is a new model for the anti-inflammatory actions of GLP-1” drugs, said Daniel Drucker, senior author of the study and a senior scientist at the Lunenfeld-Tanenbaum Research Institute.”
  • JAMA Pediatrics provides good news:
    • “Question  Is maternal influenza vaccination during pregnancy associated with a reduction in influenza-associated hospitalizations and emergency department (ED) visits in infants younger than 6 months?
    • “Findings  In this case-control study of 3764 infants younger than 6 months, maternal vaccination was associated with a reduction in influenza-associated hospitalizations and ED visits in infants. Vaccine effectiveness was highest among hospitalized infants, those younger than 3 months, and those born to mothers vaccinated in the third trimester.
    • “Meaning  The findings in this study indicate that maternal influenza vaccination during pregnancy provided important protection for the infant in the first few months of life before infants are eligible for vaccination.”
  • The American Medical Association shares what doctors wish their patients knew about social drivers of health.

From the U.S. healthcare business front,

  • Bloomberg reports
    • “We’re seeing wide price variation even in the same hospitals on the same day based upon the negotiated prices by the differing health insurance carriers or health plans,” said Cynthia Fisher, founder and chairman of the philanthropic group Patient Rights Advocate, , which provides free price data for nearly all of the more than 6,000 hospitals in the US. “For the employers, this is eye-opening.”
    • “Patient Rights Advocate on Dec. 11 introduced a hospital pricing search tool for the public. The organization pointed to prices for an injection of cancer drug Rituximab at Rush University Medical Center in Chicago that ranged from $899.33 for the Cigna Basic/Premier medical plan for Rush employees administered through Allegiance Benefit Plan Management Inc. by the Cigna Group, to $9,260.13 for the Cigna One Health HMO.
    • “If they’re able to offer it at a tenth of the price, why should one employer pay 10 times more?” Fisher said.
    • “Cigna didn’t respond to a request for comment, and a spokesman for Rush said the hospital wasn’t “in a position to speak to something that specific so rapidly.”
    • “Being able to easily compare prices will protect health plans from billing errors and fraud by hospitals and insurers, Fisher said. “The employers and unions that design health plans will be able to benefit from being well-informed about their choices and decisions to seek the best quality of care at the lowest possible prices,” she said.
  • Beckers Hospital Review identifies the thirteen out of twenty most popular prescription drugs that are in shortage and the 25 largest health systems by number of physicians.
  • Healthcare IT News calls attention to the fact that “Now that telemedicine is mainstream, artificial intelligence is helping healthcare providers with imperatives such as patient triage. Early results are promising.”
  • According to Reuters,
    • “High cost, logistical issues and the prospect of potential treatment advances are holding back adoption of the first gene therapies for hemophilia, experts said this week during the American Society of Hematology’s (ASH) annual meeting.
    • “Experimental options discussed at the San Diego meeting included personalized treatments and next-generation gene therapies, many still in the earliest stages of testing.”
  • Benefits Pro lets us know about a “Cigna report [that] outlines the benefits, challenges of value-based care. The Cigna paper suggests that physicians, patients, and health plans tend to recognize the good aspects of VBC, but that change has been slow nonetheless in the private sector.”
  • Per Fierce Healthcare,
    • “Kroger is piloting value-based primary care clinics as it joins a growing list of retailers looking to cash in on the booming sector of senior-focused medical care.
    • “The grocery chain has teamed up with Better Health Group, a provider network, to shift some of its in-store clinics, called The Little Clinic, into primary care centers for seniors, in addition to offering regular services.
    • “Better Health Group is rolling out the value-based model at eight of Kroger’s Altanta-area stores.
    • “The clinics today provide a full range of services from your acute, convenient care to primary care-like functions. About 60% of patients that we see in the clinic don’t have an assigned or designated primary care provider. So, there’s a huge opportunity just in general to serve patients and provide longitudinal care,” said Jim Kirby, chief commercial officer for Kroger Health, in an interview with Fierce Healthcare.”

Friday Factoids

David Ermer–AHRQ, CDC, COVID-19, Medical / Rx research, OPM, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Yesterday, OPM’s Office of Inspector General posted its Semi-annual Report to Congress for September 30, 2023. OPM has not yet posted its Management Response thereto.
  • The HHS Office of Inspector General also issued its latest Semi-annual Report to Congress.
  • Federal News Network reports that federal employees in Japan continue to experience healthcare access problems.
  • The Director of HHS’s Agency for Healthcare Research and Quality explains how the Biden Administration is tackling financial strains on healthcare consumers.

From the public health and medical research front,

  • Beckers Clinical Leadership tells us,
    • “CDC Director Mandy Cohen, MD, said the season of respiratory syncytial virus is in “full swing” as flu slowly begins and COVID-19 leads the most hospitalizations and deaths, CNN reported Nov. 30. 
    • “What to know about COVID-19, RSV and flu:
      • “COVID-19: Dr. Cohen said while COVID-19 is “relatively low,” it remains the primary reason for new respiratory admissions and deaths. In November, each week saw between 14,000 and 18,000 hospitalizations and about 1,000 deaths. 
        • “The CDC revealed a new wastewater data tracking dashboard to track local and national trends per variant, and the dashboard also tracks mpox viruses. 
        • “Between Nov. 1 and Nov. 20, the most recent CDC information available, the proportion of wastewater sites reporting high increases of SARS-CoV-2 samples grew from 22% to 32%. During the same time, the proportion of wastewater sites finding decreasing samples slimmed from 60% to 49%. 
      • RSV: “Hospitalizations for RSV have been slightly rising, with RSV accounting for 0.5% of all hospitalizations in late October and 0.8% as of Nov. 18, according to the CDC. Ten states and New York City are reporting high levels of respiratory virus activity. Louisiana and South Carolina reported “very high” respiratory virus activity levels and Alabama, California, Colorado, Florida, Georgia, Mississippi, New Mexico and Texas are seeing “high” levels.
      • Flu: “The flu season is beginning as national estimates reveal 3.9% of healthcare visits were for flu for the week ending Nov. 25, a 0.2 percentage point increase from the prior week.  Most of the U.S. is reporting an increase in flu, with hot spots appearing in the South Central, Southeast, Mountain and West Coast regions. Twenty-five states and territories are reporting minimal flu activity.
        • “Hospitalizations for flu have grown for the third consecutive week.” 
  • The Wall Street Journal reports,
    • “The Centers for Disease Control and Prevention is urging people to avoid eating certain cantaloupe products amid a salmonella outbreak that has resulted in at least two deaths in the U.S.
    • “At least 117 people across 34 states have become sick after eating contaminated cantaloupe since mid-October, according to the CDC. At least 61 people have been hospitalized and two have died in Minnesota. The federal agency said the number of people sickened by the outbreak is likely much higher.
    • “The agency said it’s particularly concerned about the outbreak because the illnesses have been severe and some have occurred in long-term-care facilities and child-care centers. Fourteen people in long-term-care facilities and seven children who attended child-care facilities have been sickened, the CDC said.”
  • STAT News informs us,
    • “Advances in treatments for congenital heart abnormalities mean more patients are living into adulthood, with over 2 million adults estimated to have the condition in the U.S. But that means more are also developing heart failure as they grow older — and many aren’t receiving proper care.
    • “A new study published this week in the Journal of the American Heart Association found that while hospitalizations of adults with congenital heart disease stayed stable from 2010 to 2020, the proportion of admissions for those who have heart failure more than doubled from 6.6% to 14%.
    • “These patients with heart failure also had worse outcomes after hospitalization, with an 86% higher risk of death, a 73% higher risk of major heart and brain complications, and a 26% higher risk of hospital readmission.
    • “The findings suggest that adults with congenital heart disease who also have heart failure are an especially high-risk population, and they may need closer monitoring and unique treatment regimens.”
  • Health Day offers these key takeaways from recent study results:
    • “Sticking to your scheduled mammograms can significantly reduce your risk of death from breast cancer
    • “Women who got all their scheduled mammograms had a 66% to 72% reduced risk of breast cancer death
    • “Regular mammograms make it more likely that breast cancers can be caught early, when they are more treatable.”
  • Mercer Consulting discusses why an end to HIV in our country is in sight and shares five ways to address HIV in the workplace.
  • The American Hospital Association News adds
    • “Nine out of 10 people receiving medical care for HIV through the Ryan White HIV/AIDS Program in 2022 were virally suppressed, meaning they cannot sexually transmit the virus if they take their HIV medication as prescribed, according to the latest annual data from the Health Resources and Services Administration program.”

From the U.S. healthcare business front,

  • EBRI posted Fast Facts about the changing nature of primary care in our country.
    • “Among users of primary care, 95–97 percent utilized it in an office setting prior to 2020, but only 86 percent did so from 2020–2021 as employees began using telemedicine (7–8 percent) and urgent care clinics (3–4 percent) with greater frequency due to the COVID-19 pandemic.
    • “There has been a consistent downward trend in the share of employees whose primary care office visits are at a general/family practice, falling from 42 percent in 2013 to 37 percent in 2021. In addition, primary care office visits at internal medicine providers have fallen from 21 percent in 2013 to 17 percent in 2021.
    • “Finally, the provision of primary care by a medical doctor has fallen from 9 percent in 2013 to 4 percent in 2021. In contrast, primary are provision by nurse practitioners and physician assistants has risen over time. The share of employees whose primary care office visits have been with a physician assistant rose from 2 percent in 2013 to 6 percent in 2021.
    • “The corresponding change for nurse practitioners has been from 4 percent in 2013 to 16 percent in 2021.”
  • BioPharma Dive lets us know,
    • “Pfizer will not advance a twice-daily dose of an experimental obesity drug into further testing after results from a mid-stage study showed high rates of gastrointestinal side effects and participant dropout. 
    • “Treatment did lead to significant weight loss compared to placebo over the course of the Phase 2b study. Placebo-adjusted reductions in body weight ranged from 8% to 13% at 32 weeks, Pfizer said in a statement Friday. Discontinuation rates were more than 50% on some drug doses, however.
    • “Moving forward, Pfizer will turn its focus to a once-daily version that’s currently being tested in a study meant to determine how the drug’s processed by the body. Data are expected in the first half of next year.”
  • Healthcare Dive reports,
    • “Community Health Systems announced on Friday it has completed the sale of three Florida hospitals to Tampa General Hospital for about $294 million in cash.
    • “The deal includes 120-bed Bravera Health Brooksville, 124-bed Bravera Health Spring Hill and 128-bed Bravera Health Seven Rivers, as well as their associated assets, physician clinic operations and outpatient services, according to a press release.
    • “The sale allows the for-profit hospital operator to “deliberately focus our resources in markets that we deem as most investable and that can produce greater growth and returns over the long term,” CHS CEO Tim Hingtgen said during a call with investors shortly after the divestiture was announced this summer.” 
  • MedCity News explains how payers can break down barriers that prevent access to value-based virtual care.
  • Per Fierce Healthcare,
    • Daniel Jones, who pens the investment newsletter Crude Value Insights, wrote in an analysis that because Cigna and Humana have fairly different focuses despite both being large health plans, there is potential that the merger could be viewed as more of a vertical deal than a horizontal one, which is less likely to stymie competition.
    • Cigna is a far smaller player in the Medicare Advantage space while Humana’s insurance business is overwhelmingly centered in MA. Humana, meanwhile, has limited reach in the commercial market, where Cigna has a far greater footprint.
  • Beckers Payer Issues adds,
    • “The sale of Cigna’s Medicare Advantage business would remove one hurdle in the company’s reported goal to merge with Humana, and Health Care Service Corp. might be part of that equation, Bloomberg reported Nov. 29.”

Post Thanksgiving Extra

David Ermer–No Surprises Act, Rx coverage, Telehealth, U.S. Healthcare–

The FEHBlog noted his plan on Wednesday to hold off on future posts until Cybersecurity Saturday. A pleasant Thanksgiving holiday resulted in the FEHBlog preparing this Friday Extra.

From Washington, DC,

  • CMS issued a No Surprises Act toolkit for consumer advocates.
  • Federal News Network tells us,
    • “As it’s the middle of open season, those eligible have until Dec. 12 to enroll or make changes to their plans under TRICARE – the Defense Department’s healthcare system – for 2024.
    • “The two main plans eligible for enrollment are TRICARE Prime, which includes the U.S. Family Health Plan, and TRICARE Select. TRICARE Open Season does not apply to its premium plans – TRICARE Young Adult, TRICARE Reserve Select and TRICARE Retired Reserve. TRICARE Open Season also does not apply to those who are eligible for Medicare or those using TRICARE For Life. It also does not apply to active duty service members. These groups do not have to do anything during the Open Season.
    • “Open Season is an opportunity for you to evaluate the health care coverage that your family has and to see if you need to change plans or if you want to stay in the current plan that you’re in,” Zelle Zim, who’s on TRICARE’s policy and programs team, said at a TRICARE event on Wednesday. “You also have the opportunity to enroll in a new plan during TRICARE Open Season.”

In public health and medical research news,

  • Healthcare Dive informs us,
    • “Rates of completion for high-risk diagnostic tests and referrals were lower when ordered during a telehealth visit compared with an in-person appointment, according to a study published in JAMA Network Open. 
    • “For telehealth orders, 43% were completed during the designated time frame compared with 58% of tests and referrals requested during in-person appointments, and 57% of those ordered without any visit at all. 
    • “Failure to get tests or complete referrals is a leading cause of diagnostic errors, and safety risks can be a particular concern in primary care due to the large number of potential diagnoses, researchers said.” 
  • STAT News points out,
    • “Overdose deaths among pregnant or postpartum people skyrocketed between 2018 and 2021, according to new research published Wednesday in JAMA Psychiatry.
    • “The study, conducted by the National Institute on Drug Abuse (NIDA) and the National Institutes of Health, compared the incidence of maternal deaths for overdose of commonly misused psychotropic drugs (such as heroin and other opioids, including synthetic ones, or cocaine) among girls and women aged 10 to 44.
    • “The spike in overdose deaths was especially high among women ages 35 to 44. In 2018, the rate was 4.9 overdose maternal deaths per 100,000 mothers with a live birth; in 2021, the rate was 15.8 per 100,000. The rate of overdose death for all age groups also increased significantly, from 6.9 per 100,000 mothers in the first half of 2018 to 12.2 in the second half of 2021.”
  • Beckers Hospital Review reports, “There’s been a slight slowdown in reports of new drug shortages before the winter holiday season, but six medications recently entered the list of ongoing shortages, which includes about 300 drugs.” Becker’s article lists those six drugs.

From the U.S. healthcare business front,

  • Beckers Payer Issues notes that Blue Cross licensees are “diving into” direct healthcare delivery. “BCBS plans have spent 2023 reorganizing to better compete with larger insurers through corporate restructuring, M&A or the launch of healthcare delivery subsidiaries.”
  • Per Fierce Healthcare,
    • “Pharmacy benefit management giant Optum Rx is aiming to address maternal and fetal health by leaning on the power of independent pharmacies.
    • “The Road to Healthy Baby program launched earlier this year in three states—Louisiana, Michigan and New Mexico—and offers pregnant patients prenatal checkups and vitamins at an independent pharmacy. The initiative is part of a broader push by the PBM that seeks to harness the power of these pharmacies.
    • “Through the program, a pregnant person who maintains their prenatal vitamins across three prescriptions or a 90-day supply will receive a care kit with key items that help during pregnancy and after the baby is born.
    • “Optum has also deployed grants to local diaper banks to ensure new mothers have access to necessary supplies. Katie McCarey, vice president of pharmacy strategy and product innovation at Optum Rx, told Fierce Healthcare that the company has found in some markets that new mothers often have just one or two diapers available each day for their babies.”
  • and
    • “UPMC’s operations dipped into the red this quarter as volumes and their associated care delivery costs and insurance claims continue to climb.
    • “The Pittsburgh-based integrated nonprofit system reported Tuesday a $191 million operating loss (-2.8% operating margin) and a $421.8 million change in net assets (without donor restrictions) for the three months ended Sept. 30. During the same time a year prior, UPMC had logged a $114.5 million operating income (1.8% operating margin) and $272.6 million drop in its net assets (without donor restrictions).
    • “The organization is now sitting at a $176.5 million operating loss (-0.9%) year to date despite its strong start to 2023. Its bottom line reflects a $244.7 million net decline over nine months.
    • “In a release announcing the financial results, UPMC Executive Vice President and Chief Financial Officer stressed that the system is “staying to true its commitments” surrounding capital investments ($517 million year to date) despite industry-wide workforce challenges and other headwinds.”
  • Healthcare Dive highlights five major healthcare company bankruptcy filings in 2023. “Bankruptcies have spiked this year as federal COVID-19 funding lapsed and heightened interest rates, regulatory changes and labor shortages squeezed the sector.”

Friday Factoids

David Ermer–COVID treatment, COVID-19, Electronic health records, Mental health care, No Surprises Act, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • The American Medical Association News informs us,
    • “The Departments of Health and Human Services, Labor and the Treasury Oct. 27 issued a proposed rule intended to improve how the No Surprises Act independent dispute resolution process functions in response to feedback and challenges shared by stakeholders. The public will have 60 days to submit comments. The rule would require plans to include claim adjustment reason codes and remittance advice remark codes, among other new information, with the initial payment or notice of payment denial for certain items and services subject to the NSA protections. The rule proposes changes to the batching requirements so that Items and services could be batched in the same payment determination if they are: furnished to a single patient on one or more consecutive dates of service and billed on the same claim form (a single patient encounter); billed under the same service code or a comparable code under a different procedural code system; or anesthesiology, radiology, pathology and laboratory items and services billed under service codes belonging to the same Category I CPT code section, as specified in the agencies’ guidance. Batched items would be limited to 25 items or services in a single dispute. Lastly, the proposed rule would amend certain requirements related to the open negotiation period preceding the IDR process, the initiation of the process, the dispute eligibility review, and the payment and collection of administrative fees and certified IDR entity fees.”
  • The proposed rule will be published in the Federal Register next Friday, November 3, and the proposal creates a sixty-day public comment period.
  • Here’s a link to the government’s fact sheet on the proposed rule.
  • The FEHBlog noticed that the proposed rule would run open negotiations through the government’s IDR portal, which will increase the government’s administrative costs. It strikes the FEHBlog that the proposed rule could have established a process for the open negotiation for the parties to follow. The proposed rule will require health plan system changes, which is always expensive.
  • Also today, the Department of Health and Human Services wrote to stakeholders, including health plans, reminding them the cost of Paxlovid and other Covid drugs is shifting from the government to the private sector beginning on November 1.
  • STAT News reports,
    • “The Food and Drug Administration on Thursday approved an Eli Lilly drug that takes a new approach to treating ulcerative colitis, a chronic inflammatory disease that can cause intense gastrointestinal pain and distress.
    • “The therapy, dubbed Omvoh, is an antibody that blocks IL-23p19, an immune signaling molecule that plays a key role in sustaining the disease. It’s the first treatment to target this particular pathway in ulcerative colitis. The drug’s approval comes after two late-stage trials found that patients taking Omvoh showed a significant improvement in symptoms after both three months and a year compared with those given a placebo, and that the therapy had minimal side effects.
    • “Omvoh’s list price will be $9,593 per month for intravenous delivery and $10,360 per dose injected beneath the skin. A company spokesperson told STAT that patients who have the drug covered by commercial insurance may pay as little as $5 per month for up to 30 months.”

From the public health front,

  • Health Payer Intelligence points out,
    • “Americans are feeling more optimistic about their well-being than last year, but financial concerns and mental health challenges are still negatively impacting their health, according to a report from The Cigna Group.
    • “The second annual Vitality in America study reflects responses from 10,000 adults collected in June 2023 by Morning Consult. The study uses the Evernorth Vitality Index, a subjective measure of health and well-being, to assess Americans’ experiences with personal health, finances, and job satisfaction.
    • “Almost half of respondents said they look forward to each new day, up from 43 percent in 2022. However, fewer adults said they prioritize their physical health (39 percent), feel capable of managing their emotions (45 percent), and can financially support themselves (40 percent).
    • “The top driver of stress among US adults was finances (40 percent), followed by housing conditions (25 percent), work (25 percent), family or social relationships (25 percent), and health (24 percent).”
  • Per Fierce Healthcare,
    • “More patients are accessing their medical records online via patient portals or apps and are doing so more often than in years past, according to the Office of the National Coordinator for Health IT (ONC).
    • “From 2020 to 2022, the portion of U.S. adults who reported being offered access to their medical records by a provider or insurer increased 24% to about 3 in 5, the office wrote in a recent data brief. The percentage who said they were offered access and used it jumped 50% during the same period, from 38% to 57%, according to ONC.
    • “Together these findings demonstrate increased patient demand for and use of online health information by individuals in recent years,” the office wrote in the brief, citing data from the 6,252-respondent 2022 Health Information National Trends Survey.
    • “Patients who were offered access to their online medical records also used them more frequently—54% reported accessing their records at least three times during 2022, compared to 38% in 2020 and 26% in 2017.”
  • Healthcare IT News notes,
    • “The emergence of telehealth during the COVID-19 pandemic and the resulting surge in the adoption of telemedicine are helping address patients’ needs without major signs of safety concerns, according to a study by Kaiser Permanente.
    • “The study, published in the Annals of Internal Medicine, analyzed more than 1.5 million adult patients at Kaiser Permanente Northern California in 2021, and compared treatment and follow-up visits among primary care telemedicine (video and telephone) and in-person office visits.
    • “Of the 2,357,598 primary care visits analyzed, just over half (50.8%) utilized telemedicine, which broke down to just under 20% composed of video visits and 31.3% telephone visits.
    • “The findings indicate that medication prescriptions were lower for video and telephone visits at 38.4% and 34.6%, respectively, compared to in-person visits at 46.8%. Additionally, follow-up appointments within seven days were less frequent for in-person visits (1.3%) compared to video (6.2%) and telephone (7.6%) visits.”
  • Per Medscape,
    • “Among the 3188 people with type 2 diabetes who were adherent to their tirzepatide (Mounjaro, Lilly) regimen in four pivotal trials of the agent, a quarter achieved at least a 15% cut from their baseline body weight after 40–42 weeks of treatment, and researchers found seven baseline variables that were significantly linked with a higher incidence of this level of weight loss.
    • “These findings help inform which people with type 2 diabetes are most likely to achieve greater body weight reduction with improved cardiometabolic risk factors with tirzepatide,” say the authors.”
  • HR Dive offers advice to employers about how to extend a helping hand to employees in their first trimester of pregnancy.

From the U.S. healthcare business front,

  • Mercer Consulting offers plan design advice to self-fund health plan sponsors. For example,
    • “Commit to affordable plan designs. One of the biggest reasons people delay care is because they can’t afford to pay for care. Encourage use of preventive care and chronic condition management. 
    • “Provide advocacy support to help plan members get to the most appropriate care and setting. 
    • “Review the emerging spectrum of virtual care for options to help rein in costs while making care more accessible and affordable to plan members. 
    • “Now is the time to consider the long list of network options that exist in the market today and could result in cost savings.   
    • “If you haven’t explored reference-based pricing, you might want to do so. The protections offered by the No Surprises Act make this a more attractive and less risky option for plan members. 
    • “Make mental health a priority. People with medical conditions often have mental health needs. People with mental health needs often develop medical conditions. It is an investment you can’t afford to overlook. 
    • “Focus on pharmacy. Prescription drug costs are a top driver of medical plan cost increases mostly associated with new drugs and the cost of specialty drugs.” 
  • The Wall Street Journal reports,
    • Big Pharma is almost finished with the cough and cold medicine business.
    • French drug giant  Sanofi said Friday it plans to spin off its consumer-health business, which includes well-known brands like allergy medicine Allegra and the pain treatments IcyHot and Aspercreme.
    • — to hive off a division selling over-the-counter medicines and other retail products to focus on more commercially lucrative but scientifically riskier prescription drugs.
    • Once the split is completed as early as the fourth quarter of next year, there will be just one consumer-health business left under the umbrella of a big drugmaker parent. Germany’s Bayer will be the largest drugmaker with such a business. 
    • Sanofi and its rivals have made the moves in the hunt for higher margins and faster sales growth. “It allows Sanofi to become a pure-play biopharma company. We’ll be more agile and more focused in our areas of key areas of strength,” Chief Executive Paul Hudson said.
    • Yet the companies lose the crutch of a reliable source of cash flow and now face more pressure to hit on breakthrough medicines with large sales potential.

Monday Roundup

David Ermer–Congress, COVID-19, Federal employment benefits, HSA, Medical / Rx research, Mental health care, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington DC

  • The Wall Street Journal reports
    • “A bid by House Majority Whip Tom Emmer (R., Minn.) to serve as the House Republicans’ pick to be speaker will test whether the strong ties he built recruiting candidates and counting votes will overcome doubts from some anti-establishment lawmakers aligned with former President Donald Trump.
    • “Candidates are expected to pitch their colleagues at a forum on Monday evening ahead of an internal vote to designate a new Republican speaker nominee as soon as Tuesday morning. Beyond winning the GOP ballot, the speaker nominee will face the uphill battle to unite almost all Republicans to have a chance of winning the House vote, given Republicans’ narrow 221-212 majority.  * * *
    • “To become House speaker designate, the winning candidate must garner a majority of the votes cast within the Republican conference. The internal House GOP conference voting could go multiple rounds, with the candidate receiving the fewest number of votes dropping out after each round until a candidate wins 50% of the vote plus one. After that, the House speaker-designate must win support from a majority in the House, hitting 217 of the 433 House votes if all members show up and cast a vote for an individual.
    • “In an effort to prevent holdout candidates from delaying the process, GOP Rep. Mike Flood of Nebraska is circulating a unity pledge, which lawmakers can sign saying that they promise to back the party’s speaker designee in a House floor vote. His spokeswoman on Monday morning said that all of the candidates except [Rep. Gary] Palmer [R Alabama] have signed on.”
  • Govexec tells us
    • “Lawmakers from both parties last week revived legislation that would allow most federal employees who began their careers as temporary or seasonal workers to make catch-up contributions to their pensions so that they can retire on time.
    • “The Federal Retirement Fairness Act (H.R. 5995), introduced by Reps. Derek Kilmer, D-Wash., Gerry Connolly, D-Va., Don Bacon, R-Neb., and David Valadao, R-Calif., would allow employees enrolled in the Federal Employees Retirement System who began their careers in government as temporary workers to make catch-up contributions to their defined benefit pensions to cover for the time before they had permanent positions and were unable to contribute to their retirement accounts. The legislation was last introduced in 2021 but failed to garner support.”
  • Labor Department Assistant Secretary for Employee Benefits Security Lisa Gomez writes in her blog about Breast Cancer Awareness Month.
  • BioPharma Dive informs us,
    • “The Food and Drug Administration on Friday approved a new meningococcal vaccine, clearing Pfizer’s shot Penbraya in teenagers and young adults for protection against the five most common disease-causing serogroups.
    • “Penbraya is the first vaccine available that can provide such broad protection, which may make it more convenient than current options. While meningococcal disease is rare, it can be serious and even deadly.
  • EMPR adds that the “Food and Drug Administration (FDA) has approved Zituvio™ (sitagliptin) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.”
  • Per Medtech Dive,
    • Medtronic said Monday it received approval from the Food and Drug Administration for an extravascular defibrillator designed to treat abnormal heart rhythms and prevent sudden cardiac arrest, which can lead to death within minutes if not treated immediately.
    • Unlike traditional implantable cardioverter defibrillators, which have lead wires running between a pulse generator and the heart, Medtronic’s Aurora EV-ICD places a lead outside of the heart and veins.
    • The Aurora EV-ICD was a PMA submission to the FDA, Medtronic spokesperson Tracy McNulty said in an email. “We estimate the current global EV-ICD market to be between $300-$350 million, and expect the EV-ICD market to reach $1 billion 10 years out from the Aurora launch,” McNulty said.

From the public health / research front,

  • MedPage Today points out,
    • “Children infected with the Omicron variant of SARS-CoV-2 appear to be infectious for about 3 days after a positive test, researchers found.
    • “In a small study of 76 kids ages 7 to 18, the median duration of infectivity was 3 days for both vaccinated and unvaccinated children, Neeraj Sood, PhD, of the University of Southern California, and colleagues reported online in a JAMA Pediatrics research letter.
    • “The vast majority of children who get COVID are symptomatic for 1 to 3 days,” co-author Eran Bendavid, MD, MS, of Stanford University, told MedPage Today. “Basically that correlates with how long the virus is causing disease in their body.”
  • and
    • “Maternal mRNA COVID-19 vaccination during pregnancy was associated with lower risks of poor neonatal outcomes, including neonatal death, according to a population-based retrospective cohort study from Canada.”
  • Health Day notes,
    • “Gun homicide rates went down in 2022, following increases reported during the pandemic.
    • “But race still played an outsized role, with Black people continuing to have the highest firearm homicide rates, and by a wide margin.
    • “American Indian/Alaska Natives were the only groups to see an increase again in 2022.
  • The Wall Street Journal reports
    • “The age women start taking menopausal hormone therapy and the kind they take might affect their chances of developing dementia later in life, a new study found.
    • “Women have struggled for years with whether to take hormone therapy when they go through menopause. The medication can help relieve troubling symptoms such as hot flashes and night sweats. However, years of conflicting research on whether the therapy can lead to other health problems, including breast cancer, dementia and heart attacks, has left many women confused about what to do.
    • “This new study suggests that hormone therapy might lower—or at least not raise—your dementia risk if you take it in midlife. For older women, the study found some signs that the medication might raise it.
  • mHealth Intelligence explains that “The shift to telebehavioral healthcare during the COVID-19 pandemic is linked to fewer disruptions in psychotherapy services, indicating telehealth can be effective in supporting the continuity of these services, a new study shows.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Physicians’ decisions to leave their practices is a complex choice “with multiple interdependent factors,” and is not solely impacted by burnout, pay or frustrations with electronic health records, according to a new qualitative study published in ​​the Journal of the American Board of Family Medicine.
    • “The study, which interviewed physicians who left their ambulatory care practices between 2018 and 2021, found that they were motivated to increase time off, have more flexibility or receive higher earnings. However, other departing physicians reported higher compensation would not have persuaded them to stay.
    • “Physician practices can better retain clinicians by addressing risk factors for departure including workflow distribution across team members and ensuring adequate staffing, the report said.”
  • The Wall Street Journal reports,
    • “Roche Holding has agreed to buy the developer of a bowel-disease treatment from Roivant Sciences, a company started by Republican presidential candidate Vivek Ramaswamy, and Pfizer in a deal worth more than $7 billion.
    • “The Swiss pharmaceutical giant said Monday it would pay $7.1 billion upfront for Telavant Holdings and make a near-term milestone payment of $150 million. Roche said the deal gives it rights to commercialize Telavant’s RVT-3101 drug candidate, which has shown promise for inflammatory bowel disease and could have potential in other indications in the U.S. and Japan. 
    • “The deal is the latest example of a big pharma company turning to the deal table to bolster its pipeline of autoimmune drugs. Merck earlier this year agreed to pay more than $10 billion to buy Prometheus Biosciences, which is developing a drug for inflammatory bowel disease that would compete with Telavant’s candidate.”
  • Per Fierce Healthcare
    • “Folx Health, a virtual provider focused on LGBTQ+ health, is now in-network with Cigna, Evernorth and Blue Shield of California.
    • “Other payer partners include Blue Cross and Blue Shield of Texas and Optum for behavioral health service in Colorado and Florida, according to Folx Health’s website. Through the collaboration, insured patients can use therapy and mental health medication management with Folx’s LGBTQ-specialized clinicians. 
    • “Folx offers virtual primary care, gender-affirming care and mental health services. Making that care in-network will deliver its patients significantly lower out-of-pocket costs, per the company.”
  • Assured Partners offers HSA and FSA Account Reminders for Year-End.