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Washington Post (4/12/2024): FDA faces scrutiny on Capitol Hill - For over a year, the Food and Drug Administration has been a frequent target of probes launched by the Republican chair of the House Oversight and Accountability Committee. On Thursday, FDA Commissioner Robert Califf appeared before the panel for the first time this Congress, facing a roughly four-hour grilling on a wide range of issues, from the infant formula crisis to tobacco regulation to an abortion pill.  Califf is no stranger to lawmaker scrutiny. It’s his second tour of duty as head of the FDA, having also served a brief stint as commissioner in the Obama administration. Yet the hearing comes at a critical juncture for Califf, who may have just nine months left to enact his agenda for a massive agency charged with regulating products that account for about 20 cents of every dollar U.S. consumers spend.  Here are a few major themes from yesterday’s hearing. 

Politico Pro (4/11/2024): Cole on Healthcare - Rep. Tom Cole (R-Okla.) was voted chair of the House Appropriations Committee on Wednesday, moving squarely into the middle of GOP infighting over spending. Cole was most recently vice chair of the panel and previously chaired its Labor-HHS-Education Subcommittee. GOP Doctors’ Caucus Co-Chair Rep. Michael Burgess (R-Texas) will take over the House Rules Committee chair, which Cole is vacating to move to Appropriations. Rep. Kay Granger (R-Texas) isn’t seeking reelection and vacated the Appropriations chairship early. The health care angle: Cole’s move is likely a boon to backers of boosting NIH funding because he has long supported the agency’s mission, with close family members having had Alzheimer’s and multiple sclerosis. “It’s always good to have someone who understands health care in important positions,” Neil Trautwein, executive director of the Partnership for Employer-Sponsored Coverage and a former aide to Sen. Mitch McConnell, told Pulse. “[Cole’s] priorities on biomedical research and the NIH are important. Still, employer issues are less appropriations-driven.” He introduced a bill with Rodgers to boost NIH Down syndrome research that passed through E&C unanimously last month. He’s called for expanding access to health savings accounts and telehealth, though the Appropriations Committee has less say on those issues than other panels.

Politico Pro (4/10/2024): CMS floats $3.2B pay bump for hospitals - The Biden administration proposed a $3.2 billion increase to inpatient hospital payments for fiscal 2025 that begins Oct. 1, as well as more funding to reduce drug shortages. CMS released the proposed Inpatient Prospective Payment System rule on Wednesday that lays out new payment policies for the federal budget year. The agency proposed a 2.6 percent hike to inpatient hospital payments, slightly below the 3.1 percent boost it finalized for the current fiscal year. The hospital industry criticized the proposed number. The 2.6 percent increase won’t help hospitals “following years of high inflation and rising costs for labor, drugs and equipment,” said Ashley Thompson, senior vice president of public policy analysis and development for the trade group American Hospital Association. The smaller pay bump — compared to the prior year — could also “lead to [hospital] closures in rural and underserved areas,” Chip Kahn, CEO of the Federation of American Hospitals, said in a statement. The CMS proposal also estimated that payments to safety net hospitals in fiscal 2025 will rise by approximately $560 million compared to the prior year.

Stat (4/10/2024): NCI director expresses optimism about next era of cancer research, despite shrinking budget and brain drain - Kimryn Rathmell, director of the National Cancer Institute, gestured toward the screen and asked an audience of clinicians, researchers, and patient advocates what they thought they were looking at. Projected behind her was a patchwork of purple, red, pink, and blue squares. Moments later, a larger-than-life image of Taylor Swift flashed in the middle of the pattern, and laughter rippled through the room here at the American Association for Cancer Research annual meeting as attendees realized they were staring at a poster of the singer’s “Eras Tour.” “You’ve probably figured out this is a different kind of talk if you thought you were going to come and see the payline and what I’m thinking about budgets, where we’re making investments,” Rathmell said on Monday. “This talk is going to zoom out and just do a few thought experiments to see where we think we are headed, and to reflect on how this changes the way we do our science.” In other words, Rathmell was here to talk about the past, present, and future “eras” of cancer research. She lauded a shift in the culture of science from narrow projects in siloed labs to interdisciplinary teams drawing on new technologies and data types. That’s a trend she stressed will need to continue — and she added that it will be essential to engage more people in the research process. Rathmell also celebrated a steady decline in U.S. cancer mortality rates, even as she acknowledged a concerning rise in cancer cases among younger adults. “I am very optimistic,” she said. “The kinds of questions that we can ask today are just unparalleled. I think the way that people are willing to work together and work across boundaries has never been this strong or this committed.” Rathmell’s remarks are among her first public comments as head of NCI, the oldest of the National Institutes of Health’s centers, and they come at a complicated time for the agency. NCI is poised to play a leading role in President Biden’s reignited Cancer Moonshot, an effort to “end cancer as we know it.” But the agency is grappling with a severely limited budget and the rising cost of biomedical research. Meanwhile, public trust in science is shaky, and a growing exodus of life scientists out of academia is raising concerns about the pace of new discoveries.

Politico Pro (4/9/2024): Becerra weighs exit from Biden administration for California gubernatorial bid - Health and Human Services Secretary Xavier Becerra is considering leaving the Biden administration to mount a run for California governor in 2026, people briefed on his deliberations told POLITICO. Becerra and supporters have had conversations over the past weeks where the secretary and former California attorney general indicated to fellow Democratic officials and operatives that he would leave Washington after the November election and join the crowded field to succeed Gov. Gavin Newsom in two years. The people were granted anonymity to describe private conversations, which they characterized as more serious in recent weeks. Becerra has parked nearly $1.55 million that’s usable in the governor’s race in a committee for Superintendent of Public Instruction in 2030.

He spoke at an event Tuesday in San Francisco about the state of healthcare in the U.S. “I miss California,” Becerra said at the start of a talk at Manny’s in the Mission, a watering hole for political types. Becerra later smiled and nodded silently when someone in the audience yelled “governor!” as he paused between questions.

Axios (4/4/2024): Sen. Markey offers bill to block private equity deals in health care
- Sen. Ed Markey (D-Mass.) wants increased transparency around private equity investment in health care services companies, such as hospitals, dialysis centers, and physician groups. He also is proposing new federal abilities to stop those deals from ever happening. Markey yesterday released draft legislation called the "Health Over Wealth Act," which is aimed at both private equity and other for-profit health services providers. Both types of owners would be required to disclose a laundry list of financial and operational data, including around debt, political spending, wages, and the use of areas like hallways and waiting rooms for patient care. They'd also need to create an escrow account to cover essential health services costs for five years in the event of a facility closure. The biggest change would be vastly expanded powers for the Department of Health and Human Services: Private equity firms would need to "obtain a license" from HHS to invest, either directly or indirectly, in a health care services firm. Were a firm to fail to qualify for such a license, it could be forced to divest existing portfolio companies; HHS also could prohibit any deal, even from licensees, while it conducts a study into the impact of private equity on health care; HHS also could block any
sale-leaseback transaction that it believes "would lead to a long-term weakened financial status of the health care entity or place the public health at risk." Markey unveiled his proposal during a subcommittee field hearing in Boston, which mostly focused on the Cerberus/Steward Health situation.

Politico Pro (4/3/2024): Trump aims to bring back his stymied drug-pricing plan - Former President Donald Trump wants to reinstate a controversial drug-pricing policy stymied during his administration’s final months if he wins the election in November. The policy, which could save the government billions, was halted in 2020 before it could be implemented and would likely be challenged again by the pharma industry. It aims to reduce prices by requiring Medicare to pay no more than what other developed countries pay for the top 50 drugs that physicians administer to patients, such as cancer drug infusions. The pharma industry is already in court battles trying to stop President Joe Biden’s signature drug pricing achievement to have Medicare negotiate drug prices. That both Biden and Trump are attempting to rein in drug prices underscores the political appeal of attacking pharmaceutical companies in an election year when voters tell pollsters they are concerned about the cost of living. Joe Grogan, the former president’s domestic policy adviser, says the Trump team has had time to figure out how to legally insulate the policy in a Trump second term. "Those people who were committed to addressing that inside the administration in term one have had four years to think about it and be creative and maybe expand their thought process on how to address the legal deficiencies and deploy other tools that maybe hadn't been considered at the time,” Grogan said. At this point, those details are hard to come by with the pharma industry ready to take advantage of any legal vulnerabilities of a new strategy. But others continue to look skeptically at the policy's prospect for success. Larry Levitt, executive vice president for health policy at KFF, noted that Trump’s last-minute push in 2020 to implement the policy relied on an "expansive view" of Medicare’s authority.

Politico Pro (4/2/2024): HHS seeks to penalize hospitals to curb drug shortages - Hospitals could face penalties for not keeping enough drugs in stock in the latest bid by the Biden administration to combat drug shortages, according to HHS. HHS released a billion-dollar proposal on Tuesday that would start with incentives and later penalties to get hospitals to meet good purchasing practices to help avert shortages. It also floated a plan to require that drugmakers measure and improve manufacturing. The goal is to make hospital supply chains less susceptible to shortages, the agency said, but would require congressional approval for funding and expanded powers.“We want members of Congress and all actors in the supply chain to consider and act on the policy options presented in today’s white paper,” HHS Secretary Xavier Becerra said in a statement. Drug shortages have plagued the health care industry for decades, with generic sterile injectables the products most in short supply. The issue became more acute as overseas supply chains were crippled during the Covid-19 pandemic. HHS created a coordinator position to help improve the supply chain but has acknowledged that more needs to be done to encourage more responsible drug ordering practices. HHS wants to either boost Medicare payments or cut them depending on how a hospital does on a scorecard or other metrics of their drug purchasing. The agency did not detail how stiff the penalties or high the incentives would be. The scorecard approach may apply to an initial set of drugs and then expand to other products, according to the white paper. It could also be scaled to account for other factors, such as the size of the hospital.

Politico Pro (4/2/2024): CMS rejects drugmaker price offers, kick-starting Medicare talks - CMS said Tuesday it shot down drugmakers’ price offers for 10 pharmaceuticals subject to Medicare price negotiations, kicking off talks expected to stretch through the summer. The agency’s decision is the latest development in a negotiation process created by the Inflation Reduction Act. Officials touted the prospect of savings for those on Medicare, but the final prices won’t take effect until 2026. “CMS is proud to be negotiating in good faith with drug manufacturers to lower the prices of some of the most expensive drugs for people with Medicare,” Administrator Chiquita Brooks-LaSure said in a statement. CMS sent out initial pricing bids to the nine manufacturers of the 10 drugs in February. All the companies rejected the government’s proposals and responded with their own price offers. CMS and the drugmakers have not made the price offers public, in part because that information is considered proprietary and possibly could impact the markets. According to the IRA, the agency has offered for the companies to “participate in further discussions.” A timeline from the agency shows the negotiations are expected to stretch through Aug. 1. CMS is expected to release final price offers by Sept. 1. If a company does not accept the offer, then it can decide to no longer participate in the Medicare and Medicaid programs, key sources of revenue for the drugmakers. The companies could also be subject to an excise tax. The announcement comes as several drugmakers continue to fight drug negotiations in the courts. That legal battle has not been going well for the companies.

Stat (4/2/2024): Lawmakers want to add more Chinese biotechs to defense list - Members of Congress are asking the Biden administration to add seven more Chinese biotechs to a list of companies suspected of working with Beijing’s military. The concern is that China could “create synthetic pathogens” to win an upper hand, a March 29 letter addressed to Defense Secretary Lloyd Austin said. There’s growing concern stateside over China’s biotech sector, and legislative efforts are being considered to prevent the country from gaining access to American health and genetic data. The letter cites the companies Innomics, STOmics, Origincell, Vazyme Biotech, and others to be put on the list.

Politico Pro (3/29/2024): Joe Biden is in a race against the clock to cement his health care legacy - The Biden administration is facing a looming deadline in the next few months to finalize key health care rules. If agencies take too long to finish regulations on minimum staffing levels at nursing homes, discrimination and abortion data protections, a ban on menthol cigarettes and others still in the pipeline, they could all disappear next year. That’s because the rules would be easy pickings for Republicans should former President Donald Trump beat President Joe Biden in November and bring a Republican Congress with him. The Congressional Review Act provides an expedited process that bars use of the Senate filibuster to allow lawmakers to undo rules adopted 60 legislative days before the end of a congressional session. That’s a breeze compared with going through the lengthy notice-and-comment process that would otherwise be required to rescind a prior administration’s rules. The CRA also bars agencies from pursuing substantially similar rules going forward, unless Congress orders it. The president must sign any CRA bills overturning rules, so a Biden win in November would likely secure his regulations no matter what happens in congressional elections. But because Congress takes so many days off — and days off aren’t legislative days — the deadline to be sure they’re not covered by the CRA is likely to come this summer.

Politico Pro (3/28/2024): Biden expands window to try and keep millions more low-income Americans insured - President Joe Biden is widening a critical window for low-income Americans to join Obamacare, in a move aimed at reinforcing a central element of his reelection bid: That he presided over a historic expansion of health care coverage. Tens of millions of people eliminated from Medicaid would now have until Nov. 30 to sign up for new coverage under a plan to be announced Thursday by the Department of Health and Human Services and first shared with POLITICO — an extension from the July 31 deadline initially set for the special enrollment period. The new timeline will apply to all those seeking coverage through HealthCare.gov, with officials encouraging state-run insurance marketplaces to adopt the change as well. The move aims to minimize the number of people losing health insurance coverage in the run-up to the November election as a result of a nationwide purge of state Medicaid rolls. The mass disenrollments are happening for the first time since the pandemic, prompted by the expiration last April of a Covid-era policy meant to prevent vulnerable people from losing coverage amid the health crisis.

Politico Pro (3/28/2024): Biden administration finalizes crackdown on ‘junk’ health plans - The Biden administration finalized a rule Thursday that limits the duration of inexpensive but skimpy short-term health plans, which officials deride as junk insurance. The final rule from the departments of HHS, Labor and Treasury coincides with a major push by the White House to promote insurance coverage gains under President Joe Biden. The regulation reverses a Trump-era rule that expanded the duration of health plans that did not have to comply with Obamacare protections, such as pre-existing condition coverage. “These junk insurance plans misled consumers into thinking they were buying real insurance,” said Neera Tanden, Biden’s domestic policy adviser, during a call with reporters Wednesday. “Then when people need medical care, they find out their plans capped their benefits related to a pre-existing condition.” There aren’t any major differences between what was proposed in July 2023 and what has been finalized, which will limit the duration of coverage from three years to three months, but can be extended for one additional month.

Bloomberg (3/28/2024): Medicare Proposes Rate Hikes for Nursing Homes, Hospices - Nursing homes, hospice providers, and inpatient psychiatric facilities would all see Medicare pay hikes next year under proposals released Thursday by the Biden administration. Hospice providers would get an additional $705 million in Medicare payments in fiscal year 2025, while nursing homes would get an additional $196.5 million, as part of a proposed 4.1% rate increase (RIN 0938-AV30). The proposed hospice rate hike would represent a 2.6% boost in the payment rate, according to the proposed rule (RIN 0938-AV29) from the Centers for Medicare & Medicaid Services. Another proposed rule (RIN 0938-AV32) calls for inpatient psychiatric facilities to receive a 2.6%, or $70 million, increase in Medicare payment rates. Medicare’s hospice benefit covers end-of-life care and services for beneficiaries who are terminally ill with a life expectancy of six months or less if the illness runs its normal course. Beneficiaries who enroll in the hospice benefit agree to forgo Medicare coverage for conventional treatment of their terminal illness.

Politico Pro (3/23/2024): Senate sends $1.2T funding package to Biden, thwarting partial shutdown - A colossal $1.2 trillion spending package is finally off to President Joe Biden’s desk, with Congress concluding a tumultuous government funding cycle and skirting a shutdown after midnight. The Senate cleared the six-bill funding bundle in a 74-24 vote, following votes on a dozen Republican amendments and proposals, none of which were successful. The House approved the package earlier on Friday, with more Democrats voting for the massive measure than Republicans as Speaker Mike Johnson faces a new threat to his gavel. Almost halfway through the fiscal year, the legislation will deliver fresh budgets and a steady funding stream to the Pentagon and many non-defense agencies through September. The final passage vote caps off an especially rancorous government funding battle that began more than a year ago when House conservatives started demanding deep spending cuts from then-Speaker Kevin McCarthy, despite the reality that the Democrat-led Senate and Biden would never agree to severe reductions. “And after all of that delay — how different ultimately was the outcome?” Senate Appropriations Chair Patty Murray (D-Wash.) said Friday on the floor. In the end, the funding legislation hews closely to the spending levels McCarthy struck with Biden last summer under the bipartisan debt limit agreement, forged before the former speaker disavowed those totals at the behest of his right flank and still lost his gavel last fall. The funding package also leaves out the controversial policy stipulations House Republicans included in their own versions of the funding bills.

Politico Pro (3/22/2024): House sends $1.2T funding deal to Senate ahead of midnight shutdown cliff -
The House approved a $1.2 trillion funding package on Friday, sending the colossal measure off to the Senate with just hours to spare before federal cash expires for most of the government after midnight. Speaker Mike Johnson leaned heavily on Democratic votes to pass the package in a 286-134 vote, his usual practice with spending legislation ever since he assumed the gavel five months ago. Just 101 Republicans supported the measure, falling short of a majority of the GOP conference. The vote was held less than 36 hours after more than 1,000 pages of bill text was released in the middle of the night, a fact that infuriated conservatives. Once the Senate clears the bill, Congress will have finally closed out a particularly chaotic government funding cycle dominated by House Republican infighting. "Remember, last Congress we were all complaining: 'We can't even read these thousands of pages before we have to vote on them.’ We're now back to the House of hypocrites, and I'm so sick and tired of it,” said Rep. Marjorie Taylor Greene (R-Ga.). To try to avert a partial shutdown, Johnson defied many of the funding conditions House conservatives forced upon former Speaker Kevin McCarthy — resulting in Greene filing a motion to boot him from the speakership during the vote on Friday.

Politico Pro (3/22/2024): Granger announces plans to leave powerful spending perch early - House Appropriations Committee Chair Kay Granger plans to give up her gavel early, asking Republicans on Friday to choose a successor soon so she can step down. In a letter to Speaker Mike Johnson on Friday, the Texas Republican asked the GOP Steering Committee and the rest of the conference to elect a new chair “as soon as possible.” Granger, who isn’t running for reelection next year, said she plans to serve out the remainder of her term in the House and serve as “chair emeritus.” Granger’s announcement comes just hours after the House passed a massive $1.2 trillion funding package to stave off a shutdown at midnight, finally closing out funding needs on a fiscal year that started five months ago. It's likely the last major spending deal that she will oversee as Congress barrels toward a presidential election. In a statement, Rep. Tom Cole (R-Okla.), a senior Republican appropriator, confirmed that he's running to replace Granger. And a supporter was collecting signatures from top House Republican appropriators for a letter backing Cole's bid for chair, according to a person familiar with the letter. Some of those so-called cardinals have already announced that they're backing Cole for the gavel, including Rep. Ken Calvert (R-Calif.), who leads the Defense spending panel.

Politico Pro (3/21/2024): Here’s what’s in the spending deal for health care - The Department of Health and Human Services is set to get a slight increase in funding under a fiscal 2024 spending package released Thursday, an increase of $955 million above current funding to more than $117 billion. The proposed less-than-1-percent bump — which doesn’t keep pace with inflation — includes modest funding boosts for the National Institutes of Health, Biomedical Advanced Research and Development Authority, organ transplant system modernization and the 9-8-8 mental health crisis hotline. It also includes a one-year extension of the U.S.’ leading program to fight HIV/AIDS, known as PEPFAR. Republicans had pushed back against a reauthorization over fears funding would go to abortion providers, which the Biden administration, the program’s leaders and outside development experts deny. The deal also includes legacy riders, like the Hyde amendment prohibiting federal funding for abortion, but it doesn’t include new abortion- and reproductive health care-related provisions for which House Republicans had pushed. The details of the spending agreement come less than 48 hours before a partial government shutdown would kick in at the end of the day Friday. The House could vote on the package on that day, which means Senate action could go into the weekend. If so, a short partial shutdown may not be averted.

Politico Pro (3/21/2024): Two Johns’ subtle differences on Social Security, Medicare - Two of the top contenders to be the next Senate GOP leader are taking subtle but different approaches to the future of Social Security and Medicare. Minority Whip John Thune (R-S.D.) suggested that lawmakers take steps to ensure the programs’ continued viability — amid Democratic attacks on his party for potentially entertaining new limits to entitlements. “It's going to take courage at some point,” Thune said. “And this maybe isn't the season, but we can't wait much longer,” referring to the presidential election. The South Dakotan added: “At some point, we've got to confront the reality that Social Security and Medicare are headed for bankruptcy.” By contrast, John Cornyn (R-Texas) — Thune's chief rival so far in the race to succeed Mitch McConnell — largely demurred on entitlements. Cornyn said the political reality is that both President Joe Biden and former President Donald Trump have resisted major changes to the programs, alterations to which are a long-running third rail of U.S. politics. Both men are running to be the next Senate GOP leader in a field that could continue to grow. Their answers offer a glimpse into how they could contend with one of the thorniest issues facing Congress — the future viability of two of the nation’s most popular programs — as Republican leader.

Politico Pro (3/19/2024): CMS wants to pay docs to enter value-based care - The Biden administration will give certain primary care doctors cash to jumpstart a major shift in how Medicare pays them. On Tuesday, CMS announced a new voluntary payment model that seeks to defray the high costs of moving into value-based care, which pays doctors based on the quality of care delivered rather than reimbursement for each item or service. This shift can be expensive for primary care doctors. Medicare beneficiaries can “get care in more convenient ways, like care based at home or through virtual means,” CMS Administrator Chiquita Brooks-LaSure said in a statement making the case for value-based payment that provides doctors an incentive to pursue new ways of delivering their services. This is the latest bid by CMS to tackle the high cost of becoming an accountable care organization — providers in value-based payment arrangements that try to keep spending below a certain amount in exchange for a share of the savings. They must repay Medicare for going over the figure.

Bloomberg (3/15/2024): HHS discretionary funding for 2024 no longer faces the threat of automatic, across-the-board cuts - HHS discretionary funding for 2024 no longer faces the threat of automatic, across-the-board cutsif lawmakers rely too long on a stopgap funding measure, Jack Fitzpatrick reports. The sequestration measure in the 2023 debt-limit deal (Public Law 118-5) — which would impose a 1% cut to all discretionary spending if Congress relies on a continuing resolution until the end of April — would no long apply to nondefense discretionary spending, the Congressional Budget Office said yesterday. That’s because lawmakers have passed six spending bills that, combined with a stopgap for the rest of the government, already equate to more than a 1% cut to base nondefense discretionary spending, avoiding the need for a sequestration order. The development lifts the burden of a possible sequestration order for domestic agency budgets at the end of next month.

Politico Pro (3/13/2024): Bucshon expects Medicare pay fix by year’s end - Rep. Larry Bucshon thinks Medicare pay reforms are on the way — and soon. At the POLITICO Health Care Summit today, Bucshon (R-Ind.), a heart surgeon and member of the GOP Doctors Caucus, said he thought a multi-pronged health package would be possible before the end of the year. “We need to address the reimbursement issues at CMS,” he said, noting it was a goal before he retires from Congress early next year. He said the package could include changes to how doctors are paid by Medicare, transparency requirements for health institutions to report on their finances and other provisions aimed at getting prices down. “The American people need to understand why things cost what they do, where the money is going and where we can better utilize the resources that we have to make everyone’s life better,” he said. His comments come amid a flurry of activity in the House and Senate on reforming Medicare pay for health providers. Lawmakers hope to end the annual ritual in which the CMS proposes pay cuts for doctors, based on a complex formula Congress ordered it to create decades ago — and then doctors lobby representatives and senators to eliminate the cuts, often in a last-minute must-pass package.

Politico Pro (3/13/2024): Kelly: Doctor Medicare payments to be included in spending bill - Portions of legislation addressing the Medicare payment schedule for physicians “will be baked into” an appropriations package expected to advance this month, Rep. Robin Kelly (D-Ill.) said Wednesday. Language around the geographic index factor and other issues will be included, the House Energy and Commerce Committee member said at POLITICO’s Health Care Summit. “We don’t want doctors to cut back on their Medicare patients or to stop doing some of the charity care they do,” Kelly said. Kelly also said Medicare should cover weight-loss drugs like Wegovy and Zepbound because “obesity is a disease.” The government payer is statutorily prohibited from covering weight-loss medications. But Kelly acknowledged the difficulty of addressing the branded drugs’ cost. “Hopefully, we won’t have to legislate it, but there is a problem in the United States with obesity, so there are a lot of people that can benefit,” she said. “If enough people use it, it seems like you could bring the price down.” Kelly also voiced her support for the FDA’s proposal to ban menthol cigarettes, despite fears that moving forward with the rule could discourage Black voters from backing President Joe Biden’s reelection bid. “It might hurt him with some voters, but it’s going to save so many lives,” she said.

Politico Pro (3/13/2024): 3 takeaways from POLITICO's conversation with FDA's No. 2 - FDA Principal Deputy Commissioner Namandjé Bumpus on Wednesday didn't rule out ascending to the agency's top role if the agency's current chief were to step aside in the coming months. "Working for Commissioner [Robert] Califf's been great — he is a big reason why I'm here," Bumpus said at POLITICO’s Health Care Summit. "And I'm a civil servant, so I'm here to serve in any capacity." Bumpus displayed her diplomatic chops while responding to earlier remarks from Sen. Joe Manchin (D-W.Va.) criticizing the FDA for approving myriad opioid medications as the addiction crisis grew in the U.S. in the 2000s. Here are three policy takeaways from Bumpus' discussion: 1. The FDA wants to ensure it isn't "reinforcing biases" when using artificial intelligence; 2. Agency guidance on diversity in clinical trials is "to come;  3. Science underpins her vision for the FDA.

Politico Pro (3/11/2024): Biden budget would raise Medicare taxes on the wealthy, expand drug price negotiations - The White House’s proposed fiscal 2025 budget puts a spotlight on protecting the future of Medicare, reiterating last year’s proposal to raise taxes on the rich to increase the Medicare trust fund. “Social Security and Medicare are more than government programs. They’re a promise, a rock solid guarantee that generations of Americans have counted on that after a life of hard work, they will be able to retire with dignity and security,” Shalanda Young, director of the Office of Management and Budget, told reporters on Monday. The budget asks for $130.7 billion for HHS, a $2.2 billion increase from 2023. It includes proposals that President Joe Biden outlined in his State of the Union address, including expanding the number of drugs subject to Medicare price negotiations from 20 to eventually 50 a year, extending the $2,000 out-of-pocket prescription drug spending cap that’s set to take effect for Medicare beneficiaries next year to commercial insurance plans and extending the $35 insulin cap to the commercial market. It also proposes limiting Medicare Part D cost-sharing for more expensive generic drugs to $2 for Medicare beneficiaries and making permanent expanded premium tax credits that make Obamacare plans more affordable for middle-income people. Biden had also promised during his State of the Union address to protect Medicare and the Affordable Care Act. His budget proposes increasing taxes on the rich to extend indefinitely the solvency of the Medicare Hospital Insurance Trust Fund, as well as direct some savings from Medicare drug price negotiations into the fund.

Politico Pro (3/7/2024): In State of the Union, Biden presses to expand drug pricing wins - President Joe Biden made a bid to expand his administration’s efforts to lower drug prices during the State of the Union. “Americans pay more for prescription drugs than anywhere else in the world,” he said. “It’s wrong, and I’m ending it.” Biden scored major victories on drug pricing in the 2022 Inflation Reduction Act, chief among them giving Medicare the power to negotiate for lower prices. His administration is expected to wrap up talks with drugmakers over 10 products in September, but older Americans won’t see prices go down until 2026. On Thursday, Biden called for going further during his speech, pressing to increase the number of drugs up for negotiation to 50. He also called for expanding a $35 cap on insulin copays for Medicare patients that went into effect last year to all Americans who need the drug. Biden also pressed Congress to expand to commercial plans a $2,000 cap on out-of-pocket costs in Medicare’s prescription drug program, which is set to take effect next year. Starting this year, pharmaceuticals covered under Medicare’s Part D for prescription drugs have a cap of $3,300 for out-of-pocket costs. Patients aren’t responsible for drug costs after hitting the cap.

Politico Pro (3/6/2024): House clears long-delayed spending package ahead of shutdown deadline - The House approved a six-bill government funding package on Wednesday, sending the bill to the Senate with little time to spare before yet another government shutdown deadline. The upper chamber must now lock down an agreement to speed up votes on the $459 billion measure before the weekend, which requires consent from all 100 senators. Republicans will likely demand a number of amendment votes in exchange, though none are expected to succeed. Facing heat from his right flank, Speaker Mike Johnson relied on robust support from Democrats to pass the package in a 339-85 vote. He managed to still secure backing from a majority of the House GOP, a muted win for the speaker as conservatives grumble about his tendency to heavily lean on Democrats to pass major legislation. Ultimately, 132 Republicans supported the measure, while 207 Democrats voted in favor of the bill. And another deadline is fast approaching. Congressional leaders have until March 22 to clear another six spending bills that present an indisputably bigger challenge, comprising about 70 percent of the federal discretionary budget, including the Pentagon and health, labor and education programs.