| | | | |  | | By Daniel Payne and Krista Mahr | | | With Katherine Ellen Foley
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Health providers, patient advocates and regulators are at odds over who should see test results first. | Getty Images | FIGHTING TO DELIVER BAD NEWS — Doctors are frustrated that patients are getting test results before they can explain them, POLITICO's Ben Leonard reports. A recently implemented federal rule requires HHS to ensure that patients receive test results as soon as they become available, but doctors argue that they often need to add context and support to results before patients view them — even as technology has made the results easier to share. The disagreement, with doctors on one side and HHS and patient advocates on the other, has raised a key question: How should patients get bad news, especially in the rapidly evolving world of telehealth? Doctors say patients receive news about potentially terminal diseases or other less catastrophic but confusing test results from patient portals before they've had a chance to explain them. The doctors say they know how their patients feel. Patients "are extremely angry and have had harms they're reporting from getting instant access," said Jack Resneck, president of the American Medical Association. "We're seeing a parent who finds out at nine o'clock on a Friday night when they can't reach anybody that their child's leukemia has recurred." But patient advocates, as well as HHS, disagree. "That test result may be what someone needs in order to search for a clinical trial, an emergency second opinion, for a Social Security disability application or to connect with necessary community supports," said Grace Cordovano, a board-certified patient advocate. The regulation came after Congress passed a law barring health care organizations from hoarding patient data, though the rule allows exceptions for information that could harm patients. Now, providers, patient advocates and regulators are arguing about how broad those exceptions should be. WELCOME TO MONDAY PULSE. Smartwatches are great for more health data, but what about smart … toilets? Products to make your existing toilet smart may be on the way — with devices to analyze urine for health issues being presented at this year's Consumer Electronics Show. Is this the "evolution of the fitness tracker"? Let us know (and send tips) at dpayne@politico.com and kmahr@politico.com. TODAY ON OUR PULSE CHECK PODCAST, Katherine Ellen Foley talks with Megan Messerly about the future of the drug Lequembi now that the FDA has granted it accelerated approval to treat Alzheimer's disease. The drug targets amyloid proteins in the brain, which are thought to cause progressive dementia.
| | | | | | | A message from PhRMA: Costly out-of-pocket expenses tied to deductible and coinsurance requirements are a leading concern for patients with commercial insurance. These harmful practices put in place by insurers and pharmacy benefit managers (PBMs) are even causing patients to abandon their medicines. New IQVIA data break down how insurers and their PBMs are impacting how patients access and afford their medicines. | | | | | | | 
Leqembi showed modest benefits in people with Alzheimer's, but some health experts are concerned that the drug's benefits might outweigh its risks. | Eisai via AP | SECOND ALZHEIMER'S DRUG GETS FDA APPROVAL — On Friday, the FDA granted accelerated approval to a second Alzheimer's disease drug in the past two years that trial data show offers modest benefits to patients, Katherine reports. In trials, Leqembi, the brand name for lecanemab, a monoclonal antibody made by Eisai and Biogen, reduced the amount of amyloid protein — thought to be a cause of Alzheimer's disease — in the brains of patients living in the early stages of the disease. It also showed to moderately slow the progression of cognitive decline over time. But some health experts are concerned that the drug's modest benefits may not outweigh its associated risks. In a Phase III trial published online late last year, 14 percent of participants receiving Leqembi developed adverse effects, which include brain swelling and bleeding. Most instances were mild, but five patients in the trial needed medical care. Three people died after the trial's conclusion at which time the participants could opt to receive Leqembi in an open-label extension study. It's not clear whether Leqembi caused the deaths, but authors of a case study detailing one instance of a woman who died after receiving treatment for a stroke she had within days of receiving Leqembi said it would be "unusual" for the drug to be related to her death. Eisai has said it doesn't believe that two of those deaths are related to Leqembi. It's still investigating the third. It's also unclear how many patients would be able to afford the drug. Eisai and Biogen have priced it at about $26,500 annually. But last year, Medicare said it would only cover Alzheimer's treatments like Leqembi for patients enrolled in clinical trials — but none are currently being conducted. On Friday evening, Eisai and Biogen asked the FDA to approve Leqembi under a traditional pathway. With traditional approval, CMS would cover the drug for patients enrolled in a registry, not a randomized trial — but it still wouldn't universally cover the drug. The Alzheimer's Association asked CMS to revise its coverage determination for the drugs last year, and though the agency said it would respond, it's unclear when that would be.
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In Maine, about 40 percent of prison inmates are administered drugs to treat opioid use disorder. | Joel Page/AP Photo | ON THE FRONTLINES — Federal officials are paying attention to promising programs emerging on the frontlines of the opioid epidemic — in prisons and jails. Krista reports from Maine on the use of drugs such as buprenorphine and methadone for people who are incarcerated — a practice that has, until recently, been ignored or shunned in prisons. Maine's overdose death rate is among the highest in the country, but since introducing new interventions in its prisons, the number of overdoses has been down significantly for people leaving the system. Incidents of drug smuggling, violence and suicide attempts have also declined in Maine's prisons. Other states have seen results, too. In New York City jails, a recent study found methadone and buprenorphine treatment during incarceration reduced the risk of overdose deaths in the first month after release by 80 percent. But the programs are more exception than rule. According to one estimate, just 12 percent of jails and prisons offer medication to treat opioid use disorder. One reason for the low number could be the difficulty of getting the medications, often controlled substances, into prisons. And some critics see the programs as leaning too heavily on treatment that doesn't have a robust safety net to help people after leaving prison. Still, the changes seem to be gaining steam — especially with the Biden administration aiming to increase the number of jails and prisons offering medication for opioid use disorder by 50 percent in the next two years, pointing to Maine's system as a model.
| | | | A message from PhRMA:   | | | | | | CHINA OPENS BORDERS — After three years of pandemic travel restrictions, China removed quarantine requirements for those entering the country, POLITICO's Gian Volpicelli reports. In addition to allowing travel to and from other countries, Beijing also reopened air and sea travel with the special administrative region of Hong Kong, allowing family and friends to reunite after years spent apart. Huge lines and tens of thousands of travelers have been reported in the wake of the new policy. The reopening is the latest in a string of decisions by China to lessen restrictions after a wave of protests. New allowances — with a relatively low level of immunity in the country — have led to a spike in new cases. The reopening also comes as other countries are adding restrictions on people coming from China. But as borders reopen … BEIJING CLAMPS DOWN ON COVID CRITICISM — Even with new Covid policies in place, China's government has continued shutting down or suspending critics of pandemic regulations, POLITICO's Susannah Savage writes. Sina Weibo, a Chinese equivalent of Twitter, said it had issued temporary or permanent bans on 1,120 accounts after addressing more than 12,800 violations, including attacks on experts, scholars and medical workers, reports The Associated Press.
| | | Cavan Jones will be associate director of congressional and political affairs at the American Society of Anesthesiologists. He was previously senior manager of government relations at the American Academy of Orthopaedic Surgeons.
| | | Gaza says Israel isn't allowing enough X-ray machines in, Reuters writes. Reuters reports that Pfizer is exploring options for some rare disease and cancer drugs. Dhruv Khullar writes in The New Yorker about China's "zero Covid" policy — and why the country didn't prepare for its end. Céline Gounder writes for The New York Times' opinion section about protecting her husband's legacy amid disinformation.
| | | | A message from PhRMA: Every day, patients at the pharmacy counter discover their commercial insurance coverage does not provide the level of access and affordability they need. New data from a study by IQVIA reveal the harmful practices of insurers and their pharmacy benefit managers (PBMs) can lead to significantly higher out-of-pocket costs for medicines — causing some patients to abandon their medicines completely. Learn more. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
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