| | | | |  | | By Chelsea Cirruzzo and Ben Leonard | Presented by the Coalition to Protect America's Health Care | | | | | | 
President Joe Biden, seen here delivering remarks on his plan to protect Americans' access to affordable care last year, has a long list of health care policies to act on. | Saul Loeb/AFP via Getty Images | BIDEN’S REGULATORY CHECKUP — President Joe Biden has a long regulatory to-do list that includes deciding how certain drugs can be prescribed over telemedicine and implementing nursing-home staffing requirements, Chelsea and Ben report. The most important policies to watch are those pending before the Office of Management and Budget, said Shana Christrup, public health director at the Bipartisan Policy Center. “You have the Congressional Review Act hanging over things happening at the latter part of the year,” she told Pulse. The act allows Congress to step in to stop a federal rule. Christrup is watching developments in artificial intelligence, given Biden’s executive order requiring HHS to create strategies for AI in drug development and AI safety. She’s also eyeing a proposed rule awaiting OMB’s final review that has AI implications to strengthen health care discrimination protections under the Affordable Care Act. “Generally, what it does is if you use AI in your clinical decisions, you as a provider would be solely reliable for that clinical decision” as opposed to AI developers, she said. “Part of what HHS is struggling with is that they have to operate within their statutory authority. [Office for Civil Rights] authority covers providers, not necessarily developers.” Here’s what else is on Biden’s agenda: Telemedicine: The Drug Enforcement Administration plans to finalize rules for virtual prescribing by the fall. Pandemic rules extended until the end of 2024 have allowed patients to get controlled substances like buprenorphine for opioid use disorder and testosterone without an in-person doctor visit. Mental health parity: The administration proposed last year to go further in taking on health insurers for not providing mental health care on the same terms as other care. It’s not clear when the administration will finalize its proposal. Insurers have argued that workforce shortages have led to barriers to care. Privacy protections: HHS’ Office for Civil Rights is expected to finalize a rule this year adding language to HIPAA to bar providers and insurers from giving state officials information that could be used to investigate, sue or prosecute someone for seeking or providing an abortion. It would cover people who cross state lines for an abortion. Nursing home staffing: An administration proposal would require nursing homes to meet certain staffing requirements, a move patient advocates say doesn’t go far enough and the nursing home industry says would exacerbate an existing strain of resources. This list isn’t exhaustive: Other agenda items include updates to marijuana regulation, for which HHS has recommended loosening restrictions based on evidence of its medical benefits; the FTC’s health breach notification rule; and the FDA’s laboratory-developed test regulations. HHS is also floating tying Medicare payment to minimum cybersecurity requirements. WELCOME TO TUESDAY PULSE. The Library of Congress wants to hear your pandemic stories. Maybe they’ll also accept a mask I hand-sewed in April 2020 out of a pink bandana with hair ties for ear loops. Send your Covid-19 experiences to them and your tips, scoops and feedback to ccirruzzo@politico.com and bleonard@politico.com and follow along @ChelseaCirruzzo and @_BenLeonard_.
| | | | A message from the Coalition to Protect America's Health Care: Hospitals Help Patients. Medicare Cuts Won’t. https://actnow.protecthealthcare.org/a/no-cuts-to-care | | | | | | | 
A new study looks at the risk of birth defects associated with buprenorphine or methadone use among pregnant people. | Rogelio V. Solis/AP Photo | OPIOID TREATMENT IN PREGNANCY — When used during the first trimester of pregnancy, the opioid-use disorder drug, buprenorphine, was associated with a lower risk of birth defects when compared with methadone, another opioid treatment, according to a study published Monday in JAMA Internal Medicine. Why it matters: Last January, federal officials eliminated the waiver requirement for clinicians to prescribe buprenorphine, which researchers said would likely result in an increased uptake of the drug. The study, which looked at the drugs’ use in Medicaid patients in their first trimester between 2000 and 2018, found an 18 percent relative-risk reduction for birth defects in the infant — including malformations associated with opioid use — in patients treated with buprenorphine than with methadone. The researchers said that translates to one fewer malformation per 100 patients. Researchers caution, however, that methadone shouldn’t be entirely ruled out, particularly if a patient was using it before becoming pregnant. “It should be highlighted that any opioid agonist therapy — either buprenorphine or methadone — is strongly recommended over untreated OUD during pregnancy, which is associated with adverse outcomes due to withdrawal, return to opioid use, overdose, intravenous drug use, and inadequacy of prenatal care,” they wrote.
| | | | JOIN 1/31 FOR A TALK ON THE RACE TO SOLVE ALZHEIMER’S: Breakthrough drugs and treatments are giving new hope for slowing neurodegenerative diseases like Alzheimer’s disease and ALS. But if that progress slows, the societal and economic cost to the U.S. could be high. Join POLITICO, alongside lawmakers, official and experts, on Jan. 31 to discuss a path forward for better collaboration among health systems, industry and government. REGISTER HERE. | | | | | | | | | THE FDA’S MESSAGING IN COURT — The FDA faces several lawsuits that challenge its authority over drugs, including one that tests what the agency can say about them on social media, POLITICO’s Lauren Gardner reports. Among the suits is one in federal district court in Texas that claims the agency overstepped in its authority when it cautioned in social media against using the drug ivermectin as a Covid-19 treatment. The anti-parasitic drug has different formulations for humans and animals. Briefing in the case is scheduled to conclude Friday. The case highlights a longstanding tension at the agency between informing the public about drug safety concerns while not encroaching on the practice of medicine, the regulation of which falls to state medical boards. The FDA declined to comment on the pending litigation. Why it matters: Pharma lawyers and other experts say the case could have a chilling effect on the agency’s public health communications. “Strategically, I would not be surprised if FDA picks its battles in this space with regard to when they want to make proactive statements,” said Lisa Dwyer, a former FDA deputy chief of staff and a partner at King & Spalding. Justice Department lawyers are also set to defend the FDA's decisions loosening restrictions on medication abortion later this year before the Supreme Court. And nine lawsuits are challenging the government’s authority to negotiate drug prices with manufacturers.
| | | | A message from the Coalition to Protect America's Health Care:   | | | | | THE BIG REVEAL — Washington is awaiting the next step in the implementation of the first Medicare drug price negotiations: CMS is mandated to send its initial offers to the manufacturers of the opening slate of drugs selected for the program by Feb. 1. What we know: CMS must send a “concise justification” to each company of the initial maximum fair price for a selected drug. What we don’t know: It’s uncertain whether drugmakers will choose to make public the initial offers from CMS. What’s next: Each manufacturer will have 30 days to accept the proposed price or make a counteroffer. If the companies choose to counter, CMS will hold up to three negotiation meetings during the spring and summer if the agency doesn’t accept it. On Aug. 1, the negotiation period ends, and by Sept. 1, the government will publish the final drug prices in the first negotiations. Those prices will take effect in 2026.
| | | | COVID SURGE RECEDING — The surge in Covid cases that coincided with the start of cold-weather season appears to be abating, according to the latest CDC data. The CDC reported a peak of 36,339 new hospital admissions during the week of Jan. 6, which dropped to 32,861 during the week of Jan. 13. It’s the first decline in hospitalizations since mid-November. Nearly all states, except for Alaska, Connecticut and Wyoming and the District of Columbia, had a decline in hospitalizations in the past week. However, the U.S. also saw about a 10 percent increase in deaths from the prior week — a metric experts say often lags behind case rates. The decline in Covid-19 hospitalizations also coincides with a decline in respiratory syncytial virus cases, which started to drop nationally after Christmas. The rate of flu cases remains elevated in most parts of the U.S., the CDC says, though outpatient visits for the flu and hospitalizations have declined in the past week.
| | | | Enter the “room where it happens”, where global power players shape policy and politics, with Power Play. POLITICO’s brand-new podcast will host conversations with the leaders and power players shaping the biggest ideas and driving the global conversations, moderated by award-winning journalist Anne McElvoy. Sign up today to be notified of new episodes – click here. | | | | | | | | | Dr. Aaron Carroll has been selected as the incoming president and CEO of AcademyHealth, replacing Dr. Lisa Simpson in March. Carroll is a distinguished professor of pediatrics and chief health officer at Indiana University.
| | NPR reports on how pharmacists in Washington are being trained to prescribe abortion drugs. KFF Health News reports on what the health care sector was selling to investors at the J.P. Morgan conference, from artificial intelligence to autoimmune disease treatments.
| | | | A message from the Coalition to Protect America's Health Care: Hospitals and health systems throughout the nation are continuing to provide critical care while under serious financial strain. But corporate insurance companies are lobbying Congress to enact harmful Medicare cuts that would put patients and the hospitals they count on at risk.
These Medicare cuts are not a solution to the challenges of health care costs and access. Cutting Medicare patients’ access to hospital care will increase the financial strain on hospitals and further threaten Americans’ access to the care they need, especially in rural and underserved communities.
Get the facts: https://actnow.protecthealthcare.org/a/no-cuts-to-care | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
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