| | | | |  | | By David Lim and Lauren Gardner | Presented by Blue Cross Blue Shield Association | | | | | | 
NIH researchers have developed an AI tool that matches patients to clinical trials. | Dirk Waem/BELGA MAG/AFP via Getty Images | AI COULD PAIR PATIENTS TO TRIALS — Imagine a world where doctors could give their patients a list of every clinical trial they are eligible to join. A new artificial intelligence algorithm developed by NIH researchers for a study released Monday could make it easier for underrepresented populations to enroll in cutting-edge research. Researchers at the NIH Library of Medicine and the National Cancer Institute developed TrialGPT, an algorithm that processes patient medical and demographic information and finds clinical trials they are eligible for. “Our study shows that TrialGPT could help clinicians connect their patients to clinical trial opportunities more efficiently and save precious time that can be better spent on harder tasks that require human expertise,” NLM senior investigator Zhiyong Lu said in a press release. Data privacy: Health policy experts say the tool, which in a pilot study cut down match-matching time by more than 40 percent, could help alleviate recruitment challenges that plague clinical trials and help boost diversity. “There’s always the patient data privacy issues that also go along with this,” said Dr. Reshma Ramachandran, an assistant professor of medicine at Yale not involved in the study. Arthur Caplan, a bioethics professor at NYU’s Langone Medical Center, said it will be important to ensure that patients consent to their data being used to search for clinical trials if the tool is deployed in real clinical settings. “Most people are going to say, ‘Yeah, sure, let me know. Absolutely. I'd want to know about that,’” Caplan said. “But there may be a few who say they don’t want to get involved in research. They don’t even want the offers.” The FDA view: FDA Commissioner Robert Califf cautioned last week at the Milken 2024 Future of Health Summit that sick patients want to interact with a human — and that clinical trials cannot “correct for a system which is structurally biased.” “Let’s just say you’re in rural West Virginia and you need to get into a diabetes trial; there may not be an endocrinologist for a long ways,” Califf said. “So we’re going to have to test out this digital human interface thing in the clinical trials arena.” IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Why are we getting bitten by mosquitoes in D.C. at the end of November? Send tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).
| | | | A message from Blue Cross Blue Shield Association: When corporate hospitals buy up independent physician practices, they mark up prices to unreasonable levels, helping their bottom line—and hurting patients. These price increases translate to higher premiums and out-of-pocket costs. Commonsense policy solutions can help ensure no patient pays more for the same services at the doctor’s office simply because a hospital renamed the building. See how Blue Cross and Blue Shield companies are working to make health care more affordable for all. | | | | | | | 
States are working to ensure free access to over-the-counter birth control, including Opill. | Justin Sullivan/Getty Images | FIRST IN RxP: STATES LEAD ON OTC BIRTH CONTROL COVERAGE — A report coming today from the Contraceptive Access Initiative offers an early look at how states flex the authorities at their disposal to ensure access to over-the-counter contraceptive options — including the new oral option Opill — at no cost to consumers. While states vary in their abilities to effect such policies without legislative action, at least nine states made moves this year to boost coverage for and access to OTC birth control products, according to the report. Only one, Delaware, did so via its legislature. States have authority over myriad health plans, including private plans, state worker plans and Medicaid. Some insurance plans do not reimburse over-the-counter medications without a prescription. States can issue a “standing order,” or a type of protocol written by state officials, so patients can receive reimbursement for those medications. Governors’ role: The states’ top executives’ involvement in publicizing OTC contraception coverage can offer two benefits, according to CAI: media attention and political cover. A governor announcing OTC benefits can attract wider media coverage in a state, helping get the word out to consumers. And a governor’s involvement can help shield lower-level health officials from backlash from detractors. What’s to come: The ideal scenario for contraception advocates is a consumer taking a package of Opill, emergency contraception or condoms to the pharmacy counter, showing their insurance card and leaving the retailer without paying out of pocket. That requires coordination among states, pharmacies and payers to ensure systems are in place to create an easy customer experience where possible. The federal government could require that plans cover OTC contraception without prescriptions and with no cost-sharing, but it’s unclear whether the incoming Trump administration would finalize such a policy, which three departments under President Joe Biden proposed doing in October. “It would be a political opportunity for the Trump administration to advance common-sense contraception coverage requirements like OTC contraception,” said Dana Singiser, CAI’s co-founder.
| | HOW A VACCINE GETS TO YOUR PROVIDER — Robert F. Kennedy Jr., President-elect Donald Trump’s pick to be Health and Human Services secretary, has spent years questioning the science behind routine immunizations that have curbed diseases that were common just decades ago. Kennedy has vowed to return federal health agencies “to their rich tradition of gold-standard, evidence-based science” and accused the FDA of waging a “war on public health.” He’s suggested that little, if any, study has been conducted on vaccine safety, a claim that’s inaccurate. While some vaccine-safety scientists want to see more research into what causes rare adverse events after certain shots, they agree the products aren’t allowed onto the market without serious consideration of their safety profiles and their effectiveness in preventing severe illness. Here’s how the vaccine application process works at the FDA:
|  | PHARMA AD RULE KICKS IN — Drugmakers must comply with the FDA’s new rule stipulating how companies disclose their products’ benefits and risks in radio and TV advertisements beginning Wednesday. The rule sets standards for displaying information, such as side effects and contraindications, on a TV ad so it’s easily readable. Language used to describe risks must be presented in a way that’s “readily understandable” — think fewer instances of a narrator rushing through a list of potential side effects. As Lauren has written, some consumer advocates worry regulators aren’t doing enough to police how drugs are promoted on social media. The FDA has authority over prescription drug promotion commissioned by or on behalf of manufacturers, packers and distributors, while the FTC regulates advertising practices broadly.
| | | | A message from Blue Cross Blue Shield Association:   | | | | | ELI LILLY SUES — Eli Lilly is the latest drugmaker to sue HHS last week over the Health Resources Service Administration's opposition to how drugmakers want to provide discounted drugs to the 340B drug-pricing program. The Indianapolis-based company said HRSA rejected a plan to have Kalderos, a third-party health care technology program, distribute cash to 340B providers when medicine was dispensed to patients. “Lilly brought this lawsuit because HRSA does not have the authority to arbitrarily reject this model, which serves the original goals of the 340B program and improves transparency, efficiency, and program integrity,” Eli Lilly said. HRSA spokesperson David Bowman said the agency has no comment on the lawsuit.
| | | Shawn Maree Bishop is now senior adviser in Akin’s lobbying and public policy practice. She previously worked for Sen. Ron Wyden (D-Ore.) on the Senate Finance Committee as chief health adviser.
| | The FDA published draft guidance with answers to frequently asked questions about cellular and gene therapy development. FDA Commissioner Robert Califf met with board members from the Alliance for a Stronger FDA on Nov. 4 to discuss funding for the agency in 2025 and 2026, according to a newly released calendar disclosure.
| | Dr. Deborah Birx, the Covid response coordinator in the first Trump administration, said Robert F. Kennedy Jr. will need a management person at his side to oversee the sprawling federal health department if he is confirmed as HHS secretary, POLITICO’s David Cohen reports. Kennedy invested in Dragonfly Therapeutics, a clinical-stage biotech company based in a Boston suburb, according to his most recent financial disclosure filed during his independent run for president, POLITICO’s Chelsea Cirruzzo reports.
| | | | A message from Blue Cross Blue Shield Association: A root cause of the health care affordability crisis is the growing trend of corporate hospital systems taking over small physician practices and reclassifying them as hospital outpatient departments. Even though it’s often the same service, with the same doctor, in the same location, the simple name change can dramatically increase costs—in some cases quadrupling a patient's bill.
If that trajectory continues, affordable health care will be out of reach for many Americans and their families.
It’s time to stop putting hospital systems’ profit over patients. Fair hospital pricing could save Americans nearly $6 billion over 10 years—see how Congress can help. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
