| | | | |  | | By Krista Mahr and Daniel Payne | | | With Katherine Ellen Foley and Megan R. Wilson
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CDC Director Rochelle Walensky and FDA Commissioner Robert Califf are set to testify before Congress this week. | Manuel Balce Ceneta/AP Photo | HEALTH OFFICIALS IN THE HOT SEAT— Several top administration health officials are getting ready to testify Wednesday on the federal response to Covid-19 in front of two subcommittees of the House Energy and Commerce Committee. Witnesses scheduled to appear at the joint hearing of the Health Subcommittee and the Oversight and Investigations Subcommittee include FDA Commissioner Robert Califf; Lawrence Tabak, the senior official performing the duties of the director of the National Institutes of Health; CDC Director Rochelle Walensky; and Dawn O'Connell, the Assistant HHS Secretary for Preparedness and Response. Republican leaders say it’s the first in a series of hearings the committee will conduct into the federal health agencies’ response to the pandemic. Last week, as Pulse reported, the committee launched its investigation into Covid’s origins, sending a letter to Tabak requesting related information and documents from the NIH. “With more than one million Americans lost to the pandemic and our government health agencies having lost the American public’s trust due to misguided mandates and lockdowns, it’s critical to thoroughly examine all aspects of the pandemic response,” Republican leaders said in a statement released earlier this month. Vaccines on the table? Stay tuned to Pulse this week to hear what committee members will grill the witnesses about. The CDC has a hunch that Covid vaccine safety — an increasingly pervasive topic on social media — could come up. People claiming the vaccine is unsafe seized on the CDC’s and the FDA’s recent announcement that they were looking into whether recipients over 65 had any heightened risk of stroke within the first three weeks of getting the bivalent booster. The CDC continues to recommend the vaccine, and a safety study published last month in the journal Vaccine reported that “no increased risk was found for non-COVID-19 mortality among recipients of three COVID-19 vaccines used in the US.” WELCOME TO MONDAY PULSE — How bad did the weekend's cold snap get? At Mount Washington in New Hampshire, it got -109 degrees bad. That's a little hard to even compute. Send us the coldest places you've ever been, news and tips to start the week at kmahr@politico.com and dpayne@politico.com. TODAY ON OUR PULSE CHECK PODCAST, Megan R. Wilson talks with Ben Leonard about recent data on marijuana’s health impacts as more regulation could be coming for cannabis and public opinion turns toward pro-legalization — and how policymakers overseeing its legalization were flying surprisingly blind about its effect on public health.
| | | | | | | 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. | | | | | | PULSE EXCLUSIVE: LAWMAKERS PRESS CMS TO BROADEN ALZHEIMER'S DRUG COVERAGE — In a letter to HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure, 74 House lawmakers urged Medicare to reconsider its coverage determination of certain Alzheimer’s drugs, including the newly approved Leqembi, Katherine reports. Currently, Medicare only covers Leqembi — an anti-amyloid monoclonal antibody granted accelerated approval by the FDA in January — for patients enrolled in a randomized clinical trial. Eisai and Biogen, Leqembi’s manufacturers, have completed a Phase III clinical trial and aren’t conducting another. In 2022, the CMS decided to limit coverage for all anti-amyloid antibodies to those enrolled in a trial to ensure they benefited patients following the FDA’s approval of Aduhelm. The Alzheimer's Association, a patient advocacy group, formally requested that CMS reconsider its coverage determination for these kinds of therapies last year to broaden access to those drugs, which cost more than $25,000 annually.
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Mounting evidence suggests that marijuana could be associated with certain health risks. | David Ramos/Getty Images | POT COMES UNDER PRESSURE — The $13.2 billion marijuana marketplace is coming under scrutiny in Congress and federal agencies as a spate of new research emerges about the drug’s impact on users’ health and well-being, POLITICO’s Ben Leonard reports. The national weed landscape: When Gallup asked Americans about legalizing weed last year, two-thirds supported it. So far, 21 states have moved to permit its use for medical reasons or for recreation, and another 16 allow medical marijuana. What Washington, D.C., is worried about: As access to pot has expanded, recent studies have uncovered worrying new information, including evidence of a rise in children accidentally ingesting edibles, a slight uptick in teenagers getting asthma in states legalizing marijuana and growing rates of simultaneous use of alcohol and marijuana among young adults. What Washington, D.C., wants to do about it: Lawmakers are starting to talk about standards on dosing, mandates for childproof containers for edibles and advertising restrictions aimed at protecting children. They’re also concerned about high-potency cannabis and its effects. Federal agencies are also taking action: The FDA recently rejected applications from companies making products out of cannabis, which were seeking regulation under the loose standards governing dietary supplements. The agency said the use of cannabidiol, or CBD, an active ingredient of cannabis, poses safety risks and Congress needs to bolster safeguards to mitigate risk.
| | | | JOIN POLITICO ON 2/9 TO HEAR FROM AMERICA’S GOVERNORS: In a divided Congress, more legislative and policy enforcement will shift to the states, meaning governors will take a leading role in setting the agenda for the nation. Join POLITICO on Thursday, Feb. 9 at World Wide Technology's D.C. Innovation Center for The Fifty: America's Governors, where we will examine where innovations are taking shape and new regulatory red lines, the future of reproductive health, and how climate change is being addressed across a series of one-on-one interviews. REGISTER HERE. | | | | | | | | BIDEN GOES ON OFFENSIVE OVER GOP-PROPOSED MEDICARE CUTS — President Joe Biden and the White House are launching a new offensive against House Republicans, blasting the party for eyeing Medicare cuts in a bid to paint the GOP as trying to harm older adults, our colleagues at Playbook reported over the weekend. On Saturday, the White House issued a release singling out a bill filed by freshman Rep. Andy Ogles (R-Tenn.) that would repeal the Inflation Reduction Act. The White House notes that the Democratic bill allowed Medicare to negotiate lower drug costs, which AARP cheered as a “historic measure” that would save beneficiaries money. It also limited annual out-of-pocket drug costs to $2,000 and capped co-pays for insulin at $35 for those on Medicare. Repealing the bill, the White House says, would “provide a handout to Big Pharma”and “be one of the biggest Medicare benefit cuts in American history.”
| | | | A message from PhRMA:   | | | | | | GAO WANTS MORE TRANSPARENCY ON NURSING HOME OWNERSHIP — A new report from the Government Accountability Office says that CMS’ consumer tool for people to review nursing home ownership needs to be easier to use. CMS is responsible for the oversight of the more than 15,000 nursing homes that participate in Medicare and Medicaid programs. The agency’s tool, called Care Compare, uses language that consumers could be unfamiliar with and makes it difficult for users to identify nursing homes under common ownership and any quality issues that might exist across homes owned by the same entity, the report found. Why it matters: Several studies have shown that nursing home ownership is tied to quality of care. Low staffing levels and quality metrics have been associated particularly with for-profit nursing homes.
| | | | JOIN TUESDAY TO HEAR FROM MAYORS AROUND AMERICA: 2022 brought in a new class of mayors leading “majority minority” cities, reshaping who is at the nation’s power tables and what their priorities are. Join POLITICO to hear from local leaders on how they’re responding to being tested by unequal Covid-19 outcomes, upticks in hate crimes, homelessness, lack of affordable housing, inflation and a potential recession. REGISTER HERE. | | | | | | | | KIND GOES TO K STREET — Former Rep. Ron Kind, a Democrat from Wisconsin, has joined law and lobbying firm Arnold & Porter, Megan reports. Kind retired earlier this year after 26 years in Congress, where he focused on tax, trade and health issues. He sat on the House Ways and Means Committee and its health subcommittee. As a senior policy adviser at Arnold & Porter, he’ll be “helping clients understand the implications and details of the historic tax, trade, and health care legislation passed in the last few years,” said Kevin O’Neill, the chair of the firm’s legislative practice group. The firm, which earned about $10.9 million in lobbying revenue last year, has a client roster that includes the Pharmaceutical Research and Manufacturers of America, biopharmaceutical company Exelixis and the Children’s Health System of Texas. Ethics rules bar him from lobbying his former House and Senate colleagues for one year after leaving Capitol Hill, although he’s free to lobby the administration immediately. In the near term, O’'Neill said, Kind will just be focused on advising clients. LOTS OF MOVES IN HHS' COMMUNICATIONS SHOP — Kamara Jones is now the acting assistant secretary for public affairs, Samira Burns is the new deputy assistant secretary for public affairs for human services, John Kraus is the new deputy assistant secretary for public affairs for public health, Brian Reich is the new director of speechwriting, Anne Feldman is the new senior adviser, Israel Igualate is now the principal deputy speechwriter, Gabriela Sibori is now the press secretary for human services, Marisa Aleguas is now the assistant speechwriter and Adrian Eng is now the senior adviser for broadcast and specialty media. Andrea Harris is joining Protect Our Care as its director of policy programs, where she'll lead the progressive advocacy group’s efforts to support the implementation of the Inflation Reduction Act. Harris most recently served as the chief of staff to Rep. Lauren Underwood (D-Ill.).
| | | The New York Times Magazine investigates why so many women in the U.S. have stopped being prescribed menopausal hormone therapy for a condition experienced by 85 percent of women. Authorities across the country are trying to find ways to prevent overdoses by tracking dangerous batches of fentanyl on the market and warning the drug’s users of its toxicity, The Washington Post reports. A long-term care facility in Iowa that put a patient in a body bag when she was still alive gets a $10,000 fine, The New York Times reports.
| | | | 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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