Happy New Year!

Happy New Year!

From Washington, DC

Congress returns to legislative and Committee business next week.

The Hill discusses four ways the Fiscal Year 2024 appropriations issues can play out in January.

The Chief Justice, Hon. John Roberts, released his year-end report on the federal judiciary. The report focuses on generative artificial intelligence.

From the public health and medical research front,

  • Fortune Well considers the reigning Omicron subvariant JN.1 or Pirola.
    • “As always, it’s impossible to distinguish COVID from the flu, RSV, and other common winter illnesses like rhinoviruses, enteroviruses, and parainfluenza viruses by symptoms alone. Even with the new, highly mutated COVID variant “Pirola” JN.1, now globally dominant, this remains true. What’s more, it’s possible to have two or more infections at the same time.
    • “As always, testing—at a health care facility or at home, in the case of COVID—is the only true way to determine the source of your illness. And while you should consult your health care provider, if your symptoms are mild and you don’t have other health conditions, the cause may not matter.”
  • The article wades into Pirola specifics.
  • The Washington Post shares what’s known about long Covid.
    • “An analysis of nearly 5 million U.S. patients who had covid, based on a collaboration between The Washington Post and research partners, showed that people infected with the coronavirus’s omicron variant are less likely to develop symptoms typical of long covid than those who had covid earlier in the pandemic. Patients exposed to the coronavirus during the first wave of pandemic illness — from early 2020 to late spring 2021 — were most prone to develop long covid, with 1 in 12 suffering persistent symptoms, the study showed.”
  • The Post points out,
    • “Although HDL helps remove cholesterol from people’s arteries, the researchers wrote that, at very high levels, HDL’s structure and actions change, and it “may become deleterious to health” in various ways.
    • “For more than six years, they tracked 18,668 study participants, all 65 or older and all physically and cognitively healthy at the start of the study. In those years, cognitive dementia was diagnosed in 850 participants (4.6 percent).
    • “Those with very high HDL levels were more likely to have developed dementia than were those with more optimal HDL levels. For instance, the oldest participants with high HDL levels (those 75 or older) were 42 percent more likely to have developed dementia than those with normal HDL levels, and overall, anyone with high HDL levels had a 27 percent increased risk for dementia.”
  • and also offers exercise-based strategies for people experiencing trouble standing up or lying down.
  • Medscape tells us
    • “Researchers made important gains in 2023 in the fight against cardiovascular disease (CVD), according to the American Heart Association’s (AHA’s) annual list of key scientific developments in the field.
    • “Every year, we compile an overview of scientific research that advances our understanding of how to prevent, treat, and manage heart disease and stroke,” Mariell Jessup, MD, AHA chief science and medical officer, said in a news release.
    • “Whether the science points to new ways to treat long-known health conditions, disparities in care, or how to prevent some of our most pressing problems, such as high blood pressure, diabetes, or obesity, the findings help people, healthcare professionals, policymakers, and others make better informed healthcare decisions,” Jessup added.
    • “[The article provides] a brief summary of some of the year’s most noteworthy developments, according to the AHA.”
  • The Wall Street Journal informs us,
    • “One of the best strategies for good health in the new year: Reduce the amount of sugar you eat.
    • Sugar sneaks into our diet in surprising ways, from coffee drinks you don’t realize are sugar bombs to small amounts that add up in bread or sauces. Looking more closely at nutrition labels and little tricks like putting a few cookies onto a plate rather than eating them straight from the bag can help.
    • “It’s worth the effort, nutrition researchers say. Studies have found that diets high in added sugars are linked to a higher risk of obesity and Type 2 diabetes. 
    • “U.S. guidelines recommend that Americans limit their consumption of added sugars to 10% of daily calories. The American Heart Association recommends a limit of 6% of calories. While overall sugar consumption has decreased in recent years, Americans still get an average of about 13% of their daily calories from added sugars, according to federal data. 
    • “Still, there’s an important distinction between added sugars—which are found in processed foods such as soda, cereal and yogurt, as well as honey and sugar itself—and sugar that occurs naturally in foods like fruit and dairy products. Foods that naturally contain sugar provide nutrients that people need and most Americans aren’t eating enough of them, nutrition researchers say.”

From the U.S. healthcare business front,

  • Medscape reports,
    • “Drugmakers including Pfizer, Sanofi and Takeda Pharmaceutical plan to raise prices in the United States on more than 500 drugs in early January, according to data analyzed by healthcare research firm 3 Axis Advisors.
    • “Excluding different doses and formulations, more than 140 brands of drugs will have their prices raised next month, the data showed. * * *
    • “More drug prices are likely to be announced over the course of January – historically the biggest month for drugmakers to raise prices.
    • “In 2023, drugmakers raised prices on 1,425 drugs, down from 2022, when they raised prices on 1,460 drugs, according to data published by 46brooklyn.
    • “While drugmakers have pared back their price increases for established drugs, prices for newly launched drugs have hit record levels.
    • “In 2022, the price of newly launched drugs topped $220,000 from around $180,000 in the first six months of 2021 suggesting a more than 20% increase. That’s in line with a JAMA-published study on drug prices which showed that between 2008 and 2021 U.S. drug launch prices grew 20% annually.”

Thursday Miscellany

From Washington, DC,

  • Federal News Network reports
    • “The Office of Personnel Management had a busy year, managing to push out plenty of proposed regulations during 2023 that aim to reform federal hiring and improve workforce challenges.
    • “Even more plans and changes appear to lie ahead, though many may come in smaller bites, and require leadership from chief human capital officers (CHCOs) and other workforce experts in government.
    • “We are fundamentally rethinking hiring in government,” OPM Director Kiran Ahuja said during a Dec. 12 CHCO Council meeting. “Our big focus has been on utilizing pooled hiring, where multiple agencies with the same need can take advantage of one hiring action … It is so incredible of a tool that we have at our disposal right now.”
  • Govexec identifies the five agencies that did the most hiring in the fiscal year that ended September 30, 2023, with support from the White House.
  • The U.S. Preventive Services Task Force released for public comments a draft research plan to form a recommendation on medication to reduce breast cancer risk. The public comment deadline is January 31, 2024.
  • HHS’s Agency for Healthcare Research and Quality posted “Social and Structural Determinants of Maternal Morbidity and Mortality: An Evidence Map.” That’s certainly worth a gander.
  • Bloomberg reports,
    • “The US Food and Drug Administration has seized thousands of units of counterfeit Ozempic, Novo Nordisk A/S’s diabetes drug that’s been adapted into a blockbuster weight-loss treatment, and warned against using them.
    • “The regulator advised wholesalers, retail pharmacies, health care practitioners and patients to check the product they have received and not distribute or sell products labeled with lot number NAR0074 and serial number 430834149057.
    • “The FDA and Novo are testing the seized products and don’t yet have information about the drugs’ identity, quality, or safety.”
  • Kiplinger provides a useful overview of Medicare Part B and D’s income-adjusted premiums for 2024, known as IRMAA. The 2024 IRMAA is calculated based on the taxpayer’s 2022 adjusted gross income. The article explains how to obtain an IRS redetermination of 2024 IRMAA due to a life-changing event, for example.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Covid-19 infections and hospitalizations are rising this holiday season, mostly in people who have had the virus before
    • “A newer Omicron subvariant known as JN.1 is the culprit behind almost half of new cases in the U.S. The World Health Organization classified JN.1 as a variant of interest on Dec. 19 and said it was spreading rapidly worldwide. 
    • “The Centers for Disease Control and Prevention said the variant’s speedy spread suggests it is either more transmissible than other circulating variants or better at evading our immune systems. But existing vaccines, treatments and tests still work against it, the CDC said.”
  • Beckers Hospital Review identifies the ten States where COVID hospital admissions are the highest and where COVID hospital admissions are rising the fastest.
  • Fierce Healthcare considers whether GLP-1 patients can stop taking the drug and keep the weight off.
    • “While the current clinical paradigm for GLP-1 treatment requires lifelong medication at the highest dose, Calibrate is exploring whether members can be transitioned off of medication while sustaining their results,” shared a Calibrate spokesperson in a statement with Fierce Healthcare. “Accordingly, Calibrate is the first and only program with a proactive plan to get members off of medication.”
    • “That program, Calibrate says, was designed with evidence-based lifestyle interventions and is a more realistic approach for patients who don’t want to stay on GLP-1s forever. The company pointed to a 2018 study in The Obesity Society that shows 10% weight loss is the average attainable weight patients can realistically attain.
    • “Unlike the STEP 1 trial, where participants regained two-thirds of their prior weight loss after ceasing semaglutide utilization but continuing lifestyle intervention, Calibrate conducted its own analysis of 512 of its members to see if it’s possible to keep the weight off through the Calibrate program by tapering the drug’s usage. Its results showed that 93% sustained greater than 10% weight loss six to 12 months after beginning to taper off GLP-1 drugs.
    • “Calibrate advises speaking with a doctor to determine if GLP-1 tapering is appropriate for them but said it could be advisable at a normal BMI or if a patient plateaus for more than three months at a maximum dose of a GLP-1 medication.”
  • NBC News reports,
    • “Eating fewer carbohydrates can slow weight gain over time. But it’s not enough to just cut back on carbs. 
    • “An analysis of data from nearly 125,000 healthy adults revealed that replacing refined carbs — white bread, white rice or sugary cereals —with whole grain foods and cutting back on animal-based fats and proteins appeared to lessen the amount of weight people gained over a four-year period, according to the report published Wednesday in JAMA Network Open. 
    • “When it comes to a low-carbohydrate diet, quality is paramount,” said the study’s senior author, Dr. Qi Sun, an associate professor in the departments of nutrition and epidemiology at the Harvard T.H. Chan School of Public Health. “The things people need to pay attention to are high-quality carbohydrates.”
  • Health Day lets us know,
    • “Colon cancer screening is a known lifesaver, but the benefit may be even bigger than experts previously assumed
    • “New statistical analysis finds recommended screening cuts the 10-year incidence of the disease from 1% to 0.5%, double that of prior estimates
    • “Mentioning this to patients should boost colon cancer screening rates, researchers hope.”
  • Medscape tells us that cardiologists are not happy with the Lown Institute’s recent report about the overutilization of coronary stents.
    • “Lown “used an extremely liberal definition of overuse,” said Wayne Batchelor, MD, FACC, chair of the Interventional Council at the ACC, noting that overuse covered any stent placed during a nonemergency.
    • “We don’t just do procedures to try to save lives in very acute situations,” he said. “We also do procedures to try to improve symptoms and quality of life,” said Batchelor, director of Interventional Cardiology at the Inova Schar Heart and Vascular Institute in Fairfax, Virginia.
    • “Batchelor said that drawing conclusions from claims data alone in this report is improper because “it’s devoid of all the clinical information that a doctor and patient would want to discuss to make a decision as to whether or not a stent would provide a meaningful benefit to the patient.”
  • and
    • discusses changes to the adult vaccination schedule for 2024.

From the U.S. healthcare business front,

  • Health IT Analytics brings us up to date on the Fast Healthcare Interoperability Resource (FHIR).
    • “Using standardized application programming interface (API) standards, FHIR allows developers to create apps that transcend this document-based environment. Applications can be plugged into a basic EHR operating system and feed information directly into the provider workflow, avoiding pitfalls of document-based exchange, which often requires providers to access data separately.
    • “But FHIR APIs require health IT developers to publish FHIR endpoints in a standardized format, according to a 2022 blog post written by Office of the National Coordinator (ONC) officials. By developing the Lantern tool — which consumes public endpoint data, tests the accessibility of these endpoints, and then reports capability information to a public-facing dashboard — ONC worked with health IT stakeholders to form consensus around a standard format to publish FHIR endpoint lists.
    • “A slew of providers, developers, and vendors have created tools that leverage the data standard. The use cases for the standard are nearly limitless and include some of the major challenges preventing healthcare organizations from increasing patient engagement, developing robust population health management programs, and diving into advanced, intelligent clinical decision support.”

Midweek Update

From Washington DC,

  • The Washington Examiner points out that four special elections for the House of Representatives will be held in 2024 before the national election on November 5, 2024. Three of the seats are being vacated by Republicans, and one by a Democrat. Due to the Republican’s already slim margin in the House, every vote does count.
  • The American Hospital News reports that the No Surprises Act regulators plan to the public comment deadline for the Federal Independent Dispute Resolution Operations proposed rule, which is currently set for next Tuesday, January 2, 2024. The FEHBlog found the referenced regulator’s notice of this decision on the CMS No Surprises Act website. The official notice, however, has not been posted in the Federal Register yet.

From the public health and medical research front,

  • Bloomberg reports,
    • Cytokinetics Inc. said its experimental drug helped patients with a genetic heart ailment in a closely watched trial.
    • “The drug improved exercise capacity and oxygen uptake in patients with the heart condition, compared with those getting a placebo, Cytokinetics said Wednesday in a statement. * * *
    • Aficamten is a once-daily pill for hypertrophic cardiomyopathy, or HCM, a genetic disease in which abnormally thick heart muscle interferes with pumping. As many as 1 in 500 people have it, though many go undiagnosed, according to the American Heart Association, and it’s regarded as the most common cause of sudden cardiac death in young people and competitive athletes. * * *
    • “Cytokinetics plans to submit the drug for clearance in the second half of 2024, Chief Executive Officer Robert Blum said on a conference call.”
  • Medscape tells us,
    • Glucagon-like peptide-1 (GLP-1) agonists, like semaglutideliraglutide, and the newly US Food and Drug Administration–approved tirzepatide, not only are gaining popularity among the public for weight loss but also are the focus of considerable attention from gastroenterology researchers.
    • “The robust interest in GLP-1 agonists was on full display here at the American College of Gastroenterology (ACG) 2023 Annual Scientific Meeting [held in mid-December], with investigators sharing results on which agent is most effective for weight loss, how they compare to bariatric surgery for weight loss or prevention of metabolic dysfunction–associated steatotic liver disease, and their potential role to prevent regain after weight-loss surgery.”

From the U.S. healthcare business front,

  • STAT News presents three issues to “watch in pharma in 2024.”
    • Obesity
    • Paying for gene and cell curative therapies, and
    • Drug pricing
  • The journalist raises an interesting point on the second topic.
    • “One possibility may be so-called value-based or outcomes-based agreements, in which coverage and reimbursement are linked to the extent to which a drug is actually effective. Simply put, the manufacturer and the payer take on a level of risk. If the drug does not do as well as expected, the manufacturer reimburses the payer for a portion or all the costs.
    • “This approach is not new. Over the past few years, more drug companies and payers have explored such deals, although they do not always work. Disputes can emerge over the way data is collected and evidence of effectiveness is captured, disagreements over incentive mechanisms and financial terms, and the availability of useful outcome measures.
    • “Another issue is the Medicaid Best Price requirement. This refers to the stipulation that a pharmaceutical company must offer its best price to Medicaid and other U.S. government health programs. But this can pose a dilemma for a drugmaker if its value-based agreement lowers the price to a payer and, therefore, must be lowered to Medicaid and others, diminishing its revenue.”