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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.

Stat (10/27/2023): ARPA-H head Renee Wegrzyn on the agency’s new Cambridge hub and plans for cancer research - In an area long known as an epicenter of innovation and investment in health care, the Advanced Research Projects Agency for Health (ARPA-H) officially launched its investor hub Thursday that will be dedicated to commercializing its research on biomedical solutions. ARPA-H, which boasts a $1.5 billion budget and is modeled after the Pentagon’s science office DARPA, is rolling out a “hub-and-spoke” structure, with two other hubs, in the D.C. suburbs and Dallas, focused on government partnerships and patient experiences respectively. The organization announced Thursday an inaugural cohort of Investor Catalyst spokes that will report to, and communicate with, the Boston-area hub. The spokes include venture investors, startups, nonprofits, researchers, and more from across the U.S. Organizations designated as spokes can receive expedited funding and contracts through ARPA-H. Renee Wegrzyn, director of ARPA-H, visited Cambridge for the launch and spoke with STAT about the agency’s plans for the future. The conversation has been edited lightly for length and clarity.

Stat (10/27/2023): Senate committee plans Nov. 8 vote on wide-ranging health care package - The Senate Finance Committee plans to vote Nov. 8 on legislation that includes substance abuse and mental health policies, reforms to drug middlemen’s business practices, and extensions to provider payment policies in Medicare and Medicaid, according to five health care lobbyists. The legislation would package together versions of health care policies that the committee has been working on for some time. The Finance Committee did not respond to confirm the upcoming hearing. Details are difficult to come by, especially on how the legislative package would be paid for, but here are a few policies that are expected to be included.

Medicare and Medicaid pay policy extensions: There are several payment policies in Medicare and Medicaid that many lawmakers would like to renew. A big one is to delay a Medicaid pay cut to a program that rewards hospitals that care for a disproportionate share of patients who are uninsured or are on Medicaid.

Drug middlemen: This is the piece with the fewest details, and one lobbyist said there is still negotiation between Senate Finance and the House over reforms to pharmacy benefit manager practices. Some lobbyists said the PBM reforms are aimed at helping pharmacies. Finance Committee Chair Ron Wyden (D-Ore.) has long complained that pharmacies in his state are being run out of business by PBM tactics.

Bloomberg (10/26/2023): HEALTH CARE BRIEF: New Speaker Wants to Skip HHS Spending Markup - Billions in cuts to federal health agencies and more abortion restrictions would head straight to the House floor without a committee markup, under a 2024 spending plan offered by new Speaker Mike Johnson (R-La.). Johnson, who ascended to the nation’s third most powerful position yesterday, sent colleagues a letter dated Oct. 23 outlining his plan to move forward on government-funding legislation — a process that’s stalled for weeks in the House as Republicans fight over the speaker’s gavel. The House Republican 2024 spending plan would cut $14 billion in HHS funding compared to the current level, bringing spending to $103.3 billion. Those proposed cuts include: $3.8 billion in cuts to the NIH, targeting reductions to the institute Anthony S. Fauci ran for nearly four decades $1.6 billion in cuts to the CDC, Eliminating the Agency for Healthcare Research and Quality, a move Republicans have tried before.

Politico Pro (10/25/2023): Democrats reject Bernie Sanders’ drug-price pressure tactics in advancing NIH nominee - Sen. Bernie Sanders tried to rally Democrats and President Joe Biden to do more to lower drug prices just a year after they ordered Medicare to negotiate with pharma. None showed up. The Vermont independent's campaign took a blow on Wednesday as Democrats joined forces with Republicans to advance Biden’s pick to lead the National Institutes of Health over Sanders' objections. The Senate Health, Education, Labor and Pensions Committee that Sanders chairs voted 15-6 to confirm Dr. Monica Bertagnolli, with five Republicans, including the panel’s ranking member Bill Cassidy of Louisiana, joining all 10 Democrats. Democrats rejected Sanders’ case, that Bertagnolli had not demonstrated she would “take on the greed and power of the drug companies and health care industry and fight for the transformative changes the NIH needs at this critical moment.”

Politico Pro (10/24/2023): Senators clinch 'minibus' deal, with 40 amendments on deck - Senators will vote on 40 amendments before final passage of the nearly $280 billion package, which combines the agriculture-FDA, Military Construction-VA and Transportation-HUD fiscal 2024 measures. Two dozen of those amendments will be bundled together and voted on in groups, while 16 amendments will receive standalone votes. Amendments to watch: At a 60-vote threshold, the Senate plans to vote on an amendment from Sens. Kevin Cramer (R-N.D.), Joe Manchin (D-W.V.) and Shelley Moore Capito (R-W.V.) that aims to stop the federal government from dictating carbon emission goals to state and local transportation agencies. At a 50-vote bar, the chamber is prepared to vote on an amendment from Sen. John Kennedy (R-La.) that would restore gun rights to veterans who need fiduciary help with their VA benefits. An amendment from Sen. J.D. Vance (R-Ohio) that seeks to ban federal mask mandates will receive a vote at a simple majority threshold as well, potentially leading to adoption. Movement of the funding package has been stalled for weeks as senators struggled to clinch a deal to speed up votes on controversial amendments like those proposals.

Politico Pro (10/23/2023): Bernie Sanders calls for probe of monopoly NIH cancer drug patent - Sen. Bernie Sanders (I-Vt.) is calling for an investigation of the National Institutes of Health two days before the Senate committee he chairs votes on the agency's new leader. On Monday, Sanders sent a letter to Department of Health and Human Services Inspector General Christi Grimm urging an investigation into an exclusive patent for an NIH-developed cervical cancer treatment that the agency proposed in September to grant to a little-known company with ties to a former NIH employee. Why it matters: According to Sanders’ letter, the treatment could be worth hundreds of millions, if not billions of dollars in revenue for the person or company that gets the patent. "Based on current law and the best interest of U.S. taxpayers who paid for this cancer therapy, it would seem to make more sense for the NIH to offer non-exclusive licenses so that multiple manufacturers can produce this important cancer therapy at reasonable and affordable prices," Sanders wrote.

Politico Pro (10/20/2023): Experts fear FDA push to get neurological drugs to market faster shortchanges patients
– The push to bring new treatments sooner to patients with devastating neurological illnesses may be giving them false hope instead. The FDA has approved nine treatments for such conditions since 2016 under a process known as accelerated approval — intended to fill an unmet medical need. The drugs are endorsed with the understanding that they are not guaranteed to treat the disease but are rather backed by data regulators and drugmakers believe could predict the treatment’s success once it’s cleared for patient use. But some experts fear the FDA has loosened its standards too much when approving drugs for some neurological diseases through this process amid pressure from some lawmakers and desperate patients. Even though the agency has brought pharmaceutical options to patients who have none, it’s not clear that the drugs, which are usually very expensive, end up helping or leading to better treatments later. “In the pursuit of life-saving drugs, benefiting people with a huge unmet medical need, we are sacrificing our standards of evidence and then we don't know if the drugs actually work or not,” said Dr. Edward Cliff, an oncology fellow and research fellow at Harvard Medical School. “It's like this slippery slope.” And the data used to assess a drug’s potential benefit is far less definitive than for other types of conditions, such as HIV and cancer. The FDA says accelerated approval is key to bringing treatments to desperate patients faster when no other options are available. “For serious and life-threatening diseases with inadequate treatment options, accelerated approval offers earlier access with some residual uncertainty regarding clinical benefit,” said Cherie Duvall-Jones, an agency spokesperson. Now a program that dates to the HIV/AIDS crisis is under scrutiny — and adding to a debate between those who want to continue using accelerated approvals for severely ill people with rare diseases and health experts who question whether it’s appropriate for neurological disorders.

Stat (10/20/2023): Pharmacists can make shortage drugs, but at what cost? - Pharmacists increasingly are being asked to make drugs in bulk for hospitals that are in short supply, and they’re even beginning to make chemotherapies. But some in the industry worry about the unintended consequences of overreliance. Hospitals’ reliance on pharmacist-made drugs, a practice called compounding, has risen in step with worsening drug shortages. When the American Society of Health-System Pharmacists surveyed its members this past summer, 59% said they increased purchases from compounders because of drug shortages. Premier, which buys drugs for about 4,400 hospitals, purchased 41% more drugs from compounding facilities in 2022 than in 2021. The rise in compounding business from drug shortages was first reported by the Wall Street Journal. Some compounders are even beginning to make chemotherapies, which are much more complicated to manufacture than other sterile injectable generics. But compounding is supposed to offer temporary relief during drug shortages and was never intended to replace generic drug manufacturers, said Kalah Auchincloss, executive vice president of regulatory compliance at the FDA regulatory consulting firm Greenleaf Health. “You’re not fixing the underlying problem, which is an economic one,” Auchincloss said. It’s “like patching a hole.”

Politico Pro (10/19/2023): NIH nominee declines to make drug pricing commitments – Dr. Monica Bertagnolli declined to say what steps, if any, she’d take to lower drug prices as the Senate HELP Committee considered her nomination to lead the National Institutes of Health on Wednesday. "If you are confirmed to be the next NIH director, will you commit to reinstating and expanding the reasonable pricing clause in NIH contracts?" Chair Bernie Sanders (I-Vt.) asked. Taxpayers deserve a fair return on their investment, Bertagnolli responded. She agreed to broadly ensure that benefits of NIH research are affordable and available but stopped short of making the commitment Sanders asked of her. "I cannot give further specifics at this time about the execution of that plan," she told him. Bertagnolli similarly told ranking member Bill Cassidy (R-La.) that she couldn't commit to not using the reasonable pricing clause if confirmed. Sanders held up the National Cancer Institute director's nomination to lead NIH for months, vowing to oppose President Joe Biden's health nominees until the White House took more actions on reducing drug prices. The committee plans to vote on Bertagnolli’s nomination next Wednesday. If it approves her, the full Senate would vote on confirmation once Majority Leader Chuck Schumer brings it to the floor. Sanders has not indicated whether he'll vote in favor.

Bloomberg (10/18/2023): Senate Plans AI Cancer Panel - Sen. Mike Rounds (R-S.D.) will lead a panel discussion tomorrow morning on artificial intelligence with a focus on cancer, his office shared exclusively with Bloomberg Government. Ned Sharpless, former director of the National Cancer Institute, will moderate the conversation, which will be open to all senators but otherwise closed-door. The bipartisan Senate AI working group, which includes Rounds, is hosting the event to help lawmakers get up to speed on AI and eventually set rules on it. Rounds has expressed an interest in AI’s potential to spur advancements across the health-care industry. Panelists also include Google’s Chief Clinical Officer Michael Howell and Argonne National Laboratory’s Rick Stevens, who is leading the Department of Energy’s AI initiatives at the lab.

Bloomberg (10/17/2023): Drug Pricing Push Hurts Cancer Research Pledge, Industry Warns – President Joe Biden is undermining one of his key—and deeply personal—health policy goals by trying to lower drug prices, the pharmaceutical lobby is warning the White House. Efforts to empower the government to negotiate with drugmakers for better prices on medicines will stifle innovation and restrict patient access to cancer treatments, the Pharmaceutical Research and Manufacturers of America wrote in a letter sent Tuesday to the White House. The letter details concerns over the Biden administration’s reconsideration of “march-in authority,” which allows the government to license an invention to a third party if a patent holder fails to make it reasonably accessible to the public. It also raised questions about the White House stance on diluting intellectual property protections at the World Trade Organization. The push to curb drug price increases creates uncertainty that could deter research and development, particularly on cancer treatments, the nation’s largest lobbying arm for drugmakers warned in the letter, obtained exclusively by Bloomberg Government. “You have, on the one hand, the administration pushing the Cancer Moonshot—which we fully support the goals of—but then at the same time advancing policies that make it harder to bring new drugs to patients, or to continue to develop existing drugs that are on the market,” said Mike Ybarra, the chief medical officer at PhRMA. The White House’s Cancer Moonshot initiative aims to prevent more than 4 million cancer deaths by 2047, a cornerstone of Biden’s health care policy and a nod to his son Beau, who died of brain cancer in 2016. But Biden’s mission to lower prescription drug costs could inadvertently stifle the medical innovations needed to achieve the Cancer Moonshot’s objective, the pharmaceutical lobby contends.