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Stat (11/29/2023): Biden defends Trump-era drug pricing rule on copay accumulators - The Biden administration is appealing a court ruling against a Trump-era regulation that aimed to protect the way health insurance companies handle some prescription drug costs — a rare moment of harmony between the two administration’s approaches to drug pricing reform. At issue is a health insurance industry practice of not counting drug company coinsurance assistance toward a patient’s out-of-pocket costs. Health plans use tools, called copay accumulators, to keep tabs on whether patients or drug companies were paying the tab for a certain medicine — and don’t count any drug company assistance toward a patient’s deductible or plan maximum. Insurers say they’re trying to control drug prices. When a drug company pays a patient’s share of a drug’s price, it’s easier to maintain a high price because patients stop caring about it. Medicare bans drug company coinsurance assistance on similar reasoning.

Politico Pro (11/29/2023): Three key takeaways from E&C’s health AI hearing - The House Energy and Commerce Health Subcommittee met Wednesday to weigh the future of artificial intelligence in health care. This was the panel’s first hearing on AI in the sector as Congress has become increasingly interested in regulating the technology. Lawmakers heard from industry witnesses about how artificial intelligence is being used in health care and how potential regulation could impact the technology. Here are three takeaways from the hearing: Don’t expect big-time legislation soon, Consensus on AI’s potential and risks but parties speaking differently about it, Consensus on data privacy

Politico Pro (11/29/2023): ‘Not a health care guy:’ Johnson likely to lean on leaders and aides for policy smarts - Health care lobbyists and advocates expect the House leadership shakeup that gave Louisiana Republican Mike Johnson the gavel and the staff exits that followed to shift more power to committee leaders and high-level staffers, a half-dozen lobbyists told POLITICO. Some of the change is driven by Johnson’s relative inexperience with health policy and his never having been in the ranks of GOP leadership, said the lobbyists, five of whom were granted anonymity to discuss the dynamic on Capitol Hill. Johnson, who is in his fourth term, opposes abortion and gender-affirming care and supports cutting government health care programs such as Medicare and Medicaid, but has an otherwise scant record to signal where he falls on other health care policies being discussed in Congress. Health care isn’t “his favorite subject,” said Joel White, a health care lobbyist and former House Ways and Means Committee staffer who founded Horizon Government Affairs. But White pointed out that Johnson led the roughly 175-member Republican Study Committee when it released a 50-page health care policy blueprint crafted in the wake of failed Republican efforts to repeal and replace Obamacare.

Politico Pro (11/28/2023): FDA to investigate CAR-T immunotherapies for cancer risk - The FDA said Tuesday it is investigating a possible link between a form of cancer immunotherapy and the development of new blood cancers. The agency is looking into whether six forms of chimeric antigen receptor T-cell therapy, also known as CAR-T therapy, may lead to the production of cancerous immune cells, known as lymphoma. The therapies are Bristol Myers Squibb's Abecma and Breyanzi; Carvykti and Kymriah made by Novartis and Johnson & Johnson Innovative Medicine; and Gilead Sciences' Tecartus and Yescarta. The six CAR-T therapies identified genetically modify patients' immune cells to fight different types of blood cancers. In a statement, the FDA said that it had received reports of patients developing immune cell malignancies during clinical trials and data collected during post-approval monitoring. However, the agency maintains that the benefits of the treatments still outweigh the potential risks.

Stat (11/28/2023): Biden invokes Defense Production Act to stem drug shortages - resident Biden is using a Cold War-era law to stem drug shortages by boosting domestic pharmaceutical manufacturing.

Biden announced the initiative at the first meeting of his supply chain resilience council. It’s based on a law, the Defense Production Act, that lets the government require private companies to make materials deemed necessary for national defense, in this case essential medicines and medical countermeasures. The White House will spend $35 million to boost domestic production of key starting materials for sterile injectables, which are the drugs that hospitals commonly use and are most prone to shortages. It comes amid a surge in shortages in commonly used hospital drugs, including chemotherapies. Both the White House and Congress have been trying to figure out how to fix the problem, and a key Senate committee announced its own hearing on the issue later on Tuesday. Both Biden and former President Trump used the Defense Production Act during the pandemic to boost production of ventilators and protective equipment. Biden also invoked the law in response to the baby formula shortage.

STAT (11/17/2023): Biden appoints Vanderbilt oncologist to head National Cancer Institute - President Biden on Friday said he plans to appoint cancer researcher and doctor Kimryn Rathmell to lead the National Cancer Institute. Rathmell will assume leadership of the $7.3 billion agency amid the administration’s efforts to relaunch Biden’s Cancer Moonshot initiative with an emphasis on screening, prevention, and better treatment. Her work over the years has focused primarily on kidney cancer and its underlying drivers. “She embodies the promise of the Biden Cancer Moonshot and has spent her career driving toward the goals Jill and I set for the initiative, to improve outcomes and boost support for those facing a cancer diagnosis,” Biden said in a statement. Rathmell currently serves on NCI’s board of directors and has been part of the National Institutes of Health’s Cancer Genome Atlas, an initiative to catalog every genetic mutation of cancer. She will come to the Bethesda, Md., campus from Nashville, Tenn., where she has spent eight years at the Vanderbilt University Medical Center researching kidney cancer genomics. Prior to Vanderbilt, the Iowa native co-directed a translational research department at the University of North Carolina.

Politico Pro (11/15/2023): E&C health subcommittee advances 21 bills to full committee - The House Energy and Commerce Health Subcommittee on Wednesday advanced 21 bills to the full committee, despite divergent views among top Democrats over a proposal that would grant four years of Medicare coverage for breakthrough medical devices. The vast majority of the bills — which include policies to increase reporting requirements by pharmacy benefit managers, change how Medicare calculates payments to doctors and delay payment cuts to Medicare clinical laboratory tests — passed out of the subcommittee by voice vote. But it is unclear how many of them will move forward in the full committee. Energy and Commerce Health Subcommittee Chair Brett Guthrie (R-Ky.) said the costs of the legislation must be offset to become law. Most of the bills have yet to be scored for estimated costs by the Congressional Budget Office. “To advance legislation through the full committee, and ultimately the House and Senate, it will need to be fully offset,” Guthrie said. “We are actively working to identify bipartisan offsets, and we will fully offset each of these bills that are considered at the full committee.” Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.) said she plans to find offsets and work with federal agencies before the full committee starts to mark up legislation. “While some bills being considered today still have a way to go, I believe that they’ll be ready in time for the full committee markup,” Rodgers said.

Politico Pro (11/15/2023): House Republicans punt Labor, Health and Education bill amid GOP infighting - Another House Republican spending bill hit the skids Wednesday as the House punted legislation to fund the departments of Labor, Health and Education until after the Thanksgiving break in the face of opposition from within their own ranks. After voting on dozens of amendments to the Labor-HHS bill Tuesday night and Wednesday morning, GOP leadership announced it would not move forward on the bill. “People want to get out of here and they'd like to get out sooner rather than later,” Rep. Tom Cole (R-Okla.) the vice chair of the appropriations committee, told POLITICO. He added that had the vote gone forward, Republicans would have “lost a lot of votes.” “The cuts are really big,” he noted. “It's hard to move.” It’s the latest setback for Republicans’ attempt to pass all 12 appropriations bills in the coming weeks. Bills to fund the Departments of Agriculture, Commerce, Justice, Housing, Transportation and the Food and Drug Administration met a similar fate after it became clear they didn’t have enough GOP votes to pass. Speaker Mike Johnson and his allies, including several committee chairs, unsuccessfully lobbied Republicans this week to rally behind the Labor-HHS bill, arguing that another misstep would raise the likelihood of getting jammed by Senate Democrats at the end of the year. Freedom Caucus members who huddled with Johnson on the floor on Tuesday — including Reps. Ralph Norman (R-S.C.) and Andy Ogles (R-Tenn.) — told POLITICO the speaker asked them for “a little grace” and to trust his “plan to actually cut spending" by passing staunchly conservative spending bills that they can use as leverage in negotiations with the Senate. But a handful of GOP holdouts from the more moderate side of the caucus were unconvinced. The decision to punt the vote left some Republicans frustrated, pointing fingers at one another and with no clear path forward when Congress returns after Thanksgiving.

Politico Pro (11/15/2023): No omnibus: Doctor groups search for a home for policy riders - House Republican leaders lauded a continuing resolution approved Tuesday that stops lawmakers from having to vote on a massive omnibus bill that usually must be passed before Congress ends work for the year.

But health industry groups say the short-term patch is far from a Christmas miracle and could deprive them of a vehicle to attach key policy riders, such as efforts to stave off doctor pay cuts that take effect next year. “Omnibuses happen for a reason,” Susan Dentzer, president and CEO of America’s Physician Groups, said in an interview with POLITICO. “It is not like they haven’t served an important purpose for many years.” The House passed the continuing resolution by a 336-95 vote. It will extend government funding for certain programs through Jan. 19 and the remainder until Feb. 2. Now the Senate must pass it by the end of Friday to avert a government shutdown. Some groups representing doctors tried but failed to stop a looming 3.4 percent cut to Medicare payments in the continuing resolution, according to four people familiar with the lobbying effort. The absence of an omnibus could affect the push for doctor pay relief, some lawmakers acknowledged. “It clearly can make it more difficult to address the [payment cuts] if it is not part of this, but I don’t think it makes it unlikely,” said Rep. Larry Bucshon (R-Ind.), referring to the continuing resolution. Congress could still pass some bills by the end of the year that include health policies, Bucshon said. He mentioned the farm bill and reauthorization of the SUPPORT Act that aims to curb opioid abuse.

STAT (11/14/2023): New NIH head says government has fallen behind pharma on clinical trials - The new National Institutes of Health director, Monica Bertagnolli, said it’s a “failure” that enrollment in government-funded clinical trials has lagged behind those funded by the pharmaceutical industry.

“If you just look at the number of patients who go on government-funded trials, it’s been completely flat over the last decade,” she said at a meeting of the advocacy group Friends of Cancer Research. “If you go and look at the number of people who go on pharma-sponsored trials, it’s just this commitment and this increase.” A Johns Hopkins University study published in 2015 showed that the pharmaceutical industry funds six times more clinical trials than the government. Industry-sponsored trials increased 43% from 2006 to 2014, while newly registered NIH-funded trials decreased 24% over the same period. Bertagnolli hedged and said that the pharmaceutical industry has produced “amazing results,” but that there is an important role for NIH in answering questions that are “not of central interest to pharma.” Some studies have shown that trials funded by the pharmaceutical industry are less likely to be published than research funded by other sources, and are more likely to produce outcomes favorable for the sponsoring company. Food and Drug Administration Commissioner Robert Califf, who was also on the panel, said he’s seeing a migration of pharma-funded clinical trial enrollment outside of the United States. Bertagnolli said her overarching philosophy is that research should be designed to help patients and physicians make better decisions together about their course of care.

Politico Pro (11/10/2023): White House unloads on Pharma, with eyes on 2024 – The White House is ramping up criticism of the price of prescription drugs chosen for the first Medicare negotiations at the same time the agency charged with bargaining is listening to patients talk about the drugs’ benefits. The split screen — patients urging Medicare negotiators to maintain access to their medications while the Biden administration almost daily criticizes drugmaker profits and lobbying power — aims to demonstrate the political potency of the landmark law allowing Medicare to negotiate the price of drugs heading into the 2024 presidential election. In nearly every recent press briefing, White House press secretary Karine Jean-Pierre dedicated the top of her afternoon press briefings to calling out the high out-of-pocket patient costs for drugs selected for negotiations. The medications she highlighted are the subject of CMS’ public meetings at which some patients bemoan the prices they pay for drugs they desperately need and others seek reassurance that access to their medications will not be disrupted. Polling shows many Americans — while overwhelmingly supportive of Medicare negotiating the drug prices — aren’t aware that the negotiations come from provisions of the 2022 Inflation Reduction Act. A spokesperson for PhRMA, the brand-name drugmakers’ lobby that has sued to halt the negotiations, said the administration’s messaging campaign distorts reality. “The administration is doing whatever it can to drown out real patient concerns with the president’s misguided price-setting policy,” said Sarah Ryan. The drugmakers argue the negotiations amount to price fixing and will curtail development of new therapies. But President Joe Biden wants to keep his message to the public focused on prices. White House spokesperson Kelly Scully said millions of older Americans on Medicare already benefit from lower health costs thanks to the actions of the administration and Democratic lawmakers.

Stat (11/7/2023): Senate panel clears PBM reforms, safety-net hospital payments - A prominent Senate panel on Wednesday passed a new package of health policy reforms that would rein in certain pharmacy middlemen practices and ensure Medicare patients aren’t paying more than insurers do for medications. The package passed the committee 26-0 with no amendments added. Sen. Ron Johnson (R-Wis.) didn’t vote. The package, crafted by Senate Finance Chair Ron Wyden (D-Ore.) and Mike Crapo (R-Idaho) also includes policy on a broad range of health care priorities, including substance abuse and mental health care and extensions to provider pay. The pharmacy benefit manager regulations build on a separate package of PBM regulations that the panel passed in July. “These measures steer America’s prescription drug market towards a state of rationality where the incentives are always to have lower costs for patients and taxpayers,” Wyden said. The provisions are shaped into a package that balances the cost and savings of the various provisions with expiring Medicare and Medicaid policies that lawmakers generally renew, making it a neat puzzle piece to include in an appropriations package whenever Congress takes up funding the government in earnest. The most impactful proposal would allow the Department of Health and Human Services to designate a list of so-called discounted drugs. Medicare beneficiaries taking those drugs would pay their share of the cost based on the net price, rather than the list price, under the new proposal. There are also broader protections that would force plans to limit patients’ out-of-pocket costs to the net prices for the products, after patients meet their deductibles. It doesn’t require cost sharing to be tied to net price, however. Both policies would take effect in 2028. A provision to ensure patients aren’t paying more for biosimilars than their brand-name biologic counterparts was not included in the markup on Wednesday because congressional budget analysts hadn’t finished estimating the costs for the proposal yet. However, both Wyden and Crapo mentioned a commitment to moving the proposal forward.

Politico Pro (11/8/2023): Partial doctor pay cut reversal passes Senate Finance Committee – The Senate Finance Committee on Wednesday unanimously advanced a bipartisan health care package by a 26-0 vote. The legislation — The Better Mental Health Care, Lower-Cost Drugs And Extenders Act — partially mitigates a Medicare payment cut for doctors, extends certain expiring Medicare and Medicaid provisions, aims to increase access to mental health care and targets pharmacy benefit manager practices. The bipartisan package is the second major swing at health care legislation by the committee this legislative session. In July, lawmakers advanced a series of provisions for pharmacy benefit managers — the pharmaceutical middlemen who manage prescription drugs for health insurers — to increase transparency around how PBMs operate. The bill contains a one-year 1.25 percent increase to Medicare reimbursement rates for doctors, who face a 3.4 percent cut next year. The Medical Group Management Association is lobbying the committee to fully offset the 3.4 percent cut, which is the second shave to reimbursement rates in as many years. “Our goal is to shore up Medicare’s effort in 2024 to boost payment for primary care,” Committee Chair Ron Wyden (D- Ore.) said. “Next year, the Finance Committee will take a deeper look at Medicare physician payment as several provisions in current law need to be reexamined.” The nonpartisan Congressional Budget Office estimates the 1.25 percent increase in reimbursement rates will cost $670 million.

Politico Pro (11/7/2023): Senate confirms Monica Bertagnolli as NIH director – The Senate confirmed Dr. Monica Bertagnolli to lead the National Institutes of Health in a 62-36 vote Tuesday. Nearly every Democrat joined 13 Republicans in filling the post responsible for overseeing billions in federal research grants, but vacant since Dr. Francis Collins left nearly two years ago. “Dr. Bertagnolli is the right person to ensure the NIH stays on the cutting edge of innovation and research and fulfills its critical mission to promote health, improve equity, keep our nation competitive and give patients across the world real hope for the future,” said Senate Appropriations Chair Patty Murray (D-Wash.) in a speech just before the vote. While Bertagnolli won confirmation with ease, her road there was rocky. After President Joe Biden tapped her to lead NIH in May, Sen. Bernie Sanders (I-Vt.) held up her nomination for months in an effort to extract a comprehensive plan to lower drug prices from the White House. He and Pennsylvania Sen. John Fetterman were the only members of the Democratic caucus to vote against confirmation. Thirty-four Republicans also voted no. In a speech preceding the vote, Sanders called Bertagnolli, who most recently led the National Cancer Institute, “an intelligent and caring person,” but said he was not convinced that “she is prepared to take on the greed and power of the drug companies.” Fetterman echoed Sanders’ concerns. As chair of the Senate committee with jurisdiction over health care nominees, Sanders refused to hold a panel vote until last month when he relented after the Biden administration struck a deal with biotech company Regeneron that included a reasonable pricing clause for a Covid therapy it's developing with federal assistance. Then five Republicans joined Democrats to advance Bertagnolli's nomination out of the Health, Education, Labor and Pensions Committee.

Stat (11/7/2023): Drug shortages and the supply chain are a matter of national security, experts say - The pandemic showed how fragile the supply chain can be, and to fix it, the United States needs to treat health care like a national security issue, said experts at a health conference here on Monday. Rep. Debbie Dingell (D-Mich.), speaking on a panel at the Milken Institute’s Future of Health Summit, warned that if the country had another pandemic or faced a bacterial biowarfare threat, “and we don’t have the capability to produce antibiotics in our country, we’ve got a problem,” she said. “So it’s a national security issue. We need to be dependent upon ourselves.” Dingell said drug shortages at the University of Michigan, which she represents, far exceed the FDA’s current drug-shortage list of more than 100 drugs. That campus has nearly 500 drugs in shortage, including basics like steroids and lidocaine. John Couris, president and CEO of Tampa General Hospital, also said that the supply chain issues are urgent, pointing to what happened with Covid pandemic supply problems and emphasizing that was just a taste of what could happen if the U.S. went to war with China, even if just a proxy war. “We have got to start bringing back manufacturing capabilities to the United States,” he said. “One way you do that is you make health care a national security issue and you look at it through that lens because you make different decisions and different investments if you did that.” Panel moderator Nicholas St. Fleur of STAT asked Dingell whether she was worried that the conflicts between Israel and Hamas and between Ukraine and Russia would have an effect on the health supply chain. “I’m worried about the world conflict, period,” she said. “But yes, any disruption in world geopolitics could impact the world supply chain, and we are too dependent on other countries. We need to build that production capability for ourselves and not be dependent on other countries, period, for a variety of reasons.” The panelists discussed 3D-printing Covid-19 swabs and finding alternative sources of personal protective equipment during the acute phase of the pandemic, but noted that the chemotherapy and generic drug shortages currently plaguing the health care system are a different game.

Scientific American (11/3/2023): Precision Cancer Drugs Glitter with Promise—If You Can Get Them - The landscape of cancer treatment changed forever in 1998, when U.S. authorities approved the first genetically tailored precision cancer therapy. The early success of the strategy ushered in precision oncology—treatment custom-designed to a tumor’s genetic signature. Access to treatment is often determined not by drug availability but by money. Though cancer drugs are usually covered by insurance, biomarker testing sometimes is not. To create new medications, drug developers often pile onto genetic targets that have already proved successful. Though this approach is important to weed out shifty cancers that have evolved their way past a drug, it doesn’t address mutations in other cases that have yet to be targeted at all.

NPR (11/2/2023): Chronic drug shortages stress hospitals and patients - As a pharmacist, Jason Chou didn't major in international relations. But a few days after the Hamas attack on Israel threw the Middle East into crisis, he and his colleagues started thinking about drug shortages. So far, Chou is concerned about a handful of items, but nothing has caused a big problem yet. There were 243 different drug shortages as of Nov. 1, according to the American Society of Health System Pharmacists. "Some of them involve oncology drugs, things we use to treat cancer," he says. "And of course, those patients are already going through a personal struggle. But now you layer on top of that the fact that the drug that is preferred to treat their cancer may not be available."

Politico Pro (11/2/2023): CMS finalizes 3.4 percent physician pay cut for next year - The Biden administration has finalized a 3.4 percent cut to Medicare payments to doctors in 2024. This is the second consecutive year reimbursement rates will decline for physicians in the program. Doctor groups have asked lawmakers to halt the cuts, noting that government payments have not kept up with the costs of running a practice, especially considering the impact of inflation over the last two years. Members of the GOP Doctors Caucus released a policy proposal last month to reform the formula CMS uses to calculate Medicare payments to doctors. The goal is to update Medicare’s calculations to reflect increased costs of running a practice stemming in part from higher inflation. This foreshadowed potential bipartisan fissures. Rep. Frank Pallone (D-N.J.), the top Democrat on the House Energy and Commerce Committee, said that many of the drafts remain “half-baked.”

Stat (11/2/2023): Key Senate panel to consider PBM, drug pricing reform package - A key Senate panel announced it will consider more policies to regulate pharmacy middlemen and ensure patients aren’t paying more than insurers do for medications. The package crafted by Senate Finance Chair Ron Wyden (D-Ore.) and Mike Crapo (R-Idaho) is slated to be marked up on Nov. 8, and includes policy on a broad range of health care priorities, including substance abuse and mental health care, and extensions to provider pay. The pharmacy benefit manager regulations build on a separate package of PBM regulations that the panel passed in July. The most impactful proposal would allow the Department of Health and Human Services to designate a list of so-called discounted drugs. Medicare beneficiaries taking those drugs would see their share of the cost based on the net price, rather than the list price, under the new proposal. Only certain kinds of drugs could be designated as discounted: those for which drugmakers already offer rebates of at least 50% of the list price, and those in certain categories. The eligible categories include drugs for chronic conditions, specifically anti-inflammatories that are inhaled corticosteroids; bronchodilators, anticholinergic agents; bronchodilators, sympathomimetic agents; respiratory tract agents; anticoagulants; and cardiovascular agents. There are also broader protections that would force plans to limit patients’ out-of-pocket costs to the net prices for the products, after patients meet their deductibles. It doesn’t require cost sharing to be tied to net price, however. Both policies would go into effect in 2028.