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Stat (7/26/2024): Kamala Harris’ views on health care were shaped by her mother, cancer researcher Shyamala Gopalan - As Vice President Kamala Harris emerges as the likely Democratic candidate in the U.S. presidential race, her background on health care issues ranging from reproductive rights to drug pricing is attracting more attention. A look at the life and work of Harris’ late mother, the prominent breast cancer researcher Shyamala Gopalan, offers insights into the personal connections that have shaped Harris’ views on health and medicine. Since assuming her role as vice president, Harris has been vocal about the legacy of her mother, who died of colon cancer in 2009. “My mother, Dr. Shyamala Gopalan, had two goals in life: to cure breast cancer and to raise my sister and me,” Harris posted on Facebook this past Mother’s Day. Gopalan, who earned her Ph.D. in nutrition and endocrinology at the University of California, Berkeley, is best known for her research on the relationship between the progesterone receptor and breast cancer. Progesterone is the hormone responsible for the development of breast tissue and menstrual cycle regulation. Gopalan studied the misregulation of its receptor in mouse mammary glands, which provided insight into progesterone modulation in humans and how breast tissue responded to hormones more broadly. We now know that imbalance or irregular signaling of progesterone can lead to excessive cell growth and tumor formations. Gopalan’s seminal work on hormones and breast cancer earned her an appointment on the President’s Special Commission on Breast Cancer under the Clinton administration.

Politico Pro (7/24/2024): Where the House funding bills stand as Republicans abandon their pre-recess push - House Republicans have canceled votes next week, prepared to leave early for recess and give up on their goal of passing a dozen fiscal 2025 spending bills before the month-long August break. The decision follows GOP leadership's failure to lock up enough support to advance several of the funding bills, with conservatives fuming over amendments and swing-district members uncomfortable with taking tough votes on funding measures that will never become law in their partisan form. While Republican leaders could continue their ambitious funding push after recess, Congress will be forced to pivot to passing a continuing resolution when lawmakers return in September, in the hopes of averting a government shutdown on Oct. 1. Then bipartisan, bicameral government funding talks are expected to ramp up after the Nov. 5 elections. Three of the most divisive bills for House Republicans, Labor-HHS-Education, Commerce-Justice-Science and Transportation-HUD, were tentatively slated for floor action next week. Those measures are unlikely to pass the House in their current form, even after recess. House Republicans faced many of the same struggles last summer, with fiscal 2024 funding bills dividing the conference over funding cuts and controversial policy provisions. But they were ultimately able to pass seven bills last year: Defense, Energy-Water, Homeland Security, Interior-Environment, Legislative Branch, Military Construction-VA and State-Foreign Operations.

Politico Pro (7/23/2024): Top device regulator Shuren to depart FDA - Jeff Shuren, the FDA’s top medical device regulator, is departing the agency later this year, according to an email he sent to agency staff on Tuesday. FDA Commissioner Robert Califf also notified staff in an email obtained by POLITICO: "It’s with mixed emotions to inform you that Jeff Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health, has announced he will be retiring from the FDA after a remarkable 28-year career in the federal sector," Shuren said he had been weighing the decision for several months with the Covid-19 pandemic "in our [rearview] mirror" and the release of the FDA's final rule on laboratory developed tests. It is not yet known where Shuren is going after he leaves the FDA. "Back in 2018 I thought we would achieve our vision by the end of 2020, or thereabouts, and that then would be a good time for me to depart," Shuren wrote. "However, Covid-19 hit, and we had a job to do. As you well know because you were there with me, too, we cannot abandon our posts in a time of crisis." Shuren was instrumental in overhauling the FDA's medical device review process and kept close relationships with lawmakers on Capitol Hill.

Politico Pro (7/22/2024): What Harris’ Senate record shows about her health policy priorities - In the four years Kamala Harris spent in the Senate before becoming Joe Biden’s vice president, the California Democrat tried to push a progressive health care agenda. From 2017 to 2021, her Senate legislative priorities spanned improving maternal health and protecting reproductive rights to ensuring health equity and revolutionizing U.S. health insurance coverage.

Harris, who’s now seeking the Democratic nod for president after President Joe Biden decided to not seek a second term, didn’t particularly succeed with that legislation — many of the bills she introduced had little chance of passing in the then-Republican-led chamber. Instead, her time in the Senate was marked by resistance to Republicans and then-President Donald Trump. Though some far-left progressives have labeled Harris as more moderate, she had one of the most liberal voting records in the Senate. The Lugar Center’s bipartisan index ranked Harris as one of the least bipartisan senators during her time in Congress. GovTrack in 2020 found Harris was “most politically left” compared with all senators, joining bipartisan bills the least often compared with other Senate Democrats. The California Democrat voted in line with then-President Trump’s position 16.4 percent of the time, one of the lowest rates of all senators, ranking just barely above progressive Sens. Bernie Sanders (I-Vt.) and Elizabeth Warren (D-Mass.), according to FiveThirtyEight. Harris voted against nearly all of Trump’s nominees for top positions. Although few of the bills Harris introduced during her Senate tenure became law or even made it out of committee, according to GovTrack, the issues she focused on as a senator might inform how her health policy agenda shakes out as she launches her presidential campaign. Harris, whom Biden endorsed Sunday, has been left of Biden on several key health care issues — including insurance coverage and abortion rights. Here’s what to know about Harris’ time in the Senate: Maternal health outcomes, Medicare for All, Reproductive health access, Improving health equity.

Politico (7/19/2024): The cost of Congress’ telehealth waffling - Congress is taking its time to decide whether Medicare should permanently pay for telehealth. The Bipartisan Policy Center says that’s a mistake. The think tank’s new policy report advises legislators to adopt a long-term Medicare reimbursement strategy that gives providers reason to invest in the service. “The potential problem there is telehealth providers and investors won’t have that certainty needed to make long-term investments in telehealth infrastructure to support continuing to integrate telehealth into our larger health care system,” Maya Sandalow, senior policy analyst at the center, told Ruth. Extending the temporary telehealth rules adopted during the Covid pandemic, which are set to expire at the end of the year — and seems to be the most likely scenario — also perpetuates standards that made sense then but don’t now. For example, telehealth is reimbursed at the same rate as in-person visits under current rules. In some cases, such as mental health appointments, parity might make sense. But in other cases, it might incentivize providers to offer only virtual care, even when in-person care is needed, the report says. The Bipartisan Policy Center thinks Congress needs to consider a more nuanced reimbursement model that accounts for how telehealth care is delivered, such as via a quick email or a full video appointment. The policy paper suggests Congress consider bundling payments to account for short follow-up interactions related to an initial visit.

Politico Pro (7/11/2024): Senate HELP weighing ways to tackle medical debt - Lawmakers on the Senate Health, Education, Labor and Pensions Committee on Thursday weighed two vastly different ways to alleviate medical debt. During a hearing with health policy advocates, Democrats favored erasing the debt to encourage Americans to get care without fear of financial strain. Ranking member Bill Cassidy (R-La.) and the other Republicans on the panel prefer to redefine government policies to ensure that hospitals use subsidies for patient care. “The leading cause of personal bankruptcy in this country is the outrageously high prices that hospitals, pharmaceutical companies and insurance companies charge the American people for the crime of getting sick,” said Committee Chair Bernie Sanders (I-Vt.). Americans owe around $220 billion in medical debt, and about 80 percent of those with debt owe more than $10,000, according to KFF, the health policy think tank. Luke Messac, attending physician at Brigham and Women’s Hospital in Boston, said cost discourages patients from receiving care for potentially preventable illnesses. Sanders introduced a bill in May that would cancel Americans’ medical debts. The hearing comes as the Biden administration announced a plan in June that would block creditors from considering an applicant’s medical debt.

Bloomberg (7/11/2024): HHS Telehealth Proposal Prompts Call for Congressional Extension - A Biden administration plan to preserve select pandemic-era telehealth policies while sunsetting others is spurring renewed calls for legislative action protecting telehealth flexibilities. The 2025 Physician Fee Schedule proposed rule, (RIN 0938-AV33) released Wednesday by the Centers for Medicare & Medicaid Services, aims to continue certain flexibilities that allow physicians to bill Medicare for services that they provide virtually. This includes continuations of waivers that allow doctors to virtually supervise resident physicians and certain practitioners to provide virtual direct supervision to auxiliary personnel. The proposal also includes patient-centered provisions such as bans on frequency limitations for in-person, nursing facility, and critical care visits and allowing audio-only telehealth services. However, the proposed rule omits key provisions that were instrumental in expanding the telehealth industry during the pandemic. These include allowing federally qualified health centers and rural health clinics to bill for telehealth services, waiving in-person examination requirements for online mental health coverage, and other measures. “Absent Congressional action, beginning January 1, 2025, the statutory restrictions on geography, site of service, and practitioner type that existed prior to the COVID-19 PHE will go back into effect,” the CMS said in a news release. The telehealth industry has experienced unprecedented growth since the onset of the pandemic, largely due to these relaxed policies. According to the Journal of the American Medical Association, telehealth visits from Medicare fee-for-service beneficiaries skyrocketed from 840,000 visits in 2019 to 52.7 million visits in 2020. Although the number of visits has tapered off since then, the growth spurred by these relaxed policies has reshaped the health-care delivery landscape, prompting calls for permanent policy changes to sustain these gains. The proposed rule is a step forward, but congressional action is necessary to broadly and permanently secure patients’ access to telehealth, said Libby Baney, partner at Faegre Drinker. Rep. Buddy Carter (R-Ga.) said the expansion of pandemic-era flexibilities is gaining momentum in Congress. His bill, the Telehealth Modernization Act (H.R. 7623), would broaden the types of practitioners eligible to bill Medicare for telehealth services and allow Medicare to retain the expanded list of telehealth services added during the Covid-19 public emergency. The bill, which advanced unanimously in May through the House Energy and Commerce Subcommittee on Health, also would provide federally qualified health centers and rural health clinics the ability to bill Medicare for virtual services.

Politico Pro (7/11/2024): House Appropriations approves FDA funding bill - House appropriators on Wednesday advanced a bill out of committee that directs $3.5 billion in taxpayer funds to the FDA by a 29-26 vote. The FDA is funded through taxpayer funds and user fees collected from regulated industries. The fiscal 2025 bill, approved by the House Appropriations Committee, lists $3.25 billion for the agency from user fees. Those totals are a small dip from current funding levels of $3.52 billion in discretionary funding and $3.2 billion in user fees. The Biden administration asked for $7.2 billion in total funding in its budget request — a higher amount than the total $6.75 billion in the House bill. Chair Tom Cole (R-Okla.) said the bill provides “an appropriate level of funding” for the FDA to ensure it can “fulfill its primary responsibilities” including protecting the safety of food, drugs and medical devices. Republicans did not include a controversial rider that would effectively ban mail delivery of abortion pills — a provision that complicated its passage last year. But the bill contains language that would prevent the FDA from using funds to finalize, issue or implement regulations to ban menthol cigarettes or flavored cigars or restrict the level of nicotine in cigarettes until certain actions targeting illegal disposable e-cigarettes are taken by the agency. The committee also advanced report language with a number of requests including a report on inspections of compounding pharmacies and outsourcing facilities. Lawmakers said they are concerned that the FDA’s accelerated approval pathway is “not uniform” across its drug and biologics centers. They asked the agency to brief the committee on steps to ensure the program is being “administered equally” across the two centers. “Further, the Committee urges FDA to clarify its guidance that when considering new therapies for Accelerated Approval, including in ALS, survivability is a clinical endpoint that will be considered, consistent with the current statute,” the report language states. Committee lawmakers also urged the agency to consider a single, shared Risk Evaluation and Mitigation Strategies for biosimilars and reference products — saying that it could drive biosimilar development and savings for patients.

Politico Pro (7/11/2024): Senate appropriators adopt totals for fiscal 2025 bills - Senate appropriators approved funding totals for a dozen annual spending bills along party lines on Thursday, while pledging to work toward a bipartisan agreement in the coming months. The full panel approved the totals, known as 302(b)s, in a 15-11 vote, kicking off the committee’s markups this summer of fiscal 2025 bills. While no Republicans supported the totals, the bills are expected to receive bipartisan support. The totals do not include tens of billions of dollars negotiated outside of funding caps under last summer’s debt limit deal, nor tens of billions of dollars in emergency cash top Senate appropriators plan to add to their annual spending bills.

The totals:

  • Agriculture-FDA: $27 billion
  • Commerce-Justice-Science: $69.2 billion 
  • Defense: $830.9 billion
  • Energy-Water: $61.5 billion
  • Financial Services: $21.2 billion
  • Homeland Security: $60.5 billion
  • Interior-Environment: $37.7 billion
  • Labor-HHS-Education: $198.7 billion
  • Legislative Branch: $7 billion
  • Military Construction-VA: $148.9 billion 
  • State-Foreign Operations: $55.7 billion  
  • Transportation-HUD: $87.7 billion

Politico Pro (7/10/2024): CMS proposes to cut Medicare payments to doctors in 2025 - CMS on Wednesday proposed to reduce Medicare payments to physicians by 2.8 percent in 2025, a cut that is all but certain to ignite calls for Congress to overrule the agency. The agency’s release of the proposed physician fee schedule rule outlines payment rates and policy changes for the 2025 calendar year. If finalized, it would be the third cut in as many years to doctors’ Medicare rates. A year ago, CMS proposed a 3.37 percent cut to payments for 2024. CMS implemented the rate decreases due to a statutory requirement that Medicare spending be budget-neutral.

Congress has stepped in over the past several years to enact some relief for doctors. Most recently, lawmakers passed a 1.68 percent boost in Medicare payments to doctors as part of a large spending package in March. The boost runs through the rest of the year. Legislators on both sides of the aisle have complained about the dire state of Medicare reimbursement rates for physicians, noting they haven't kept pace with inflation or rising labor costs. “The way Medicare pays doctors for their work has not kept up with the times, and if it’s not working for doctors, it’s not working for the patients they help,” Sen. Ron Wyden (D-Ore.) said last month when he released a white paper detailing reimbursement reforms. While lawmakers bemoan the need for short-term patches year in and out, they don’t know how to pay for a long-term fix. “The question will be at the end of the day is: Do we have to have more money, or [do] we have to redistribute some of the money already there in the health care space?” Rep. Larry Bucshon (R-Ind.), a member of the GOP Doctors Caucus, said last month. “That will be [the] challenge.” The Provider Reimbursement Stability Act introduced in the House last year would raise the budget-neutrality threshold, enabling CMS to offer more payment increases. Another bill — Strengthening Medicare for Patients and Providers Act — would also tie reimbursement rates to inflation.

Neither legislation has advanced in the House.

Bloomberg (7/4/2024): Companies Hold Back on Cutting China Ties Ahead of Biosecure Act - Few life sciences companies have taken steps to cut ties with firms named in proposed US legislation aimed at cutting reliance on China’s drug supply chain, a survey showed, underscoring lingering uncertainty around the bill. Although 26% of companies are looking to disconnect from those named — including BGI, MGI Tech, WuXi AppTec Co. and related entities — a poll conducted by Boston-based L.E.K. Consulting in June found only 2% of life sciences companies have severed ties, and 11% reported no impact on their partnership decisions. The Biosecure Act, if enacted, would restrict US federal-funded medical providers from contracting with the companies named and others connected to “foreign adversaries.” The bill, which received bipartisan support when it was introduced in January, was omitted from the National Defense Authorization Act, making it unlikely to be passed by Congress before the US presidential election in November, L.E.K. said in a report this week. There’s a 70% chance of it passing during the post-election “lame-duck session” before the next president is sworn in, Bloomberg Intelligence analyst Duane Wright said in a June 17 report. The lack of action in response to the planned legislation reflects the importance of the Chinese companies, which also include WuXi Biologics Cayman Inc., in the global pharma supply chain. A survey by industry trade association Biotechnology Innovation Organization in May reported that 79% of its member-respondents have products or contracts with Chinese suppliers and it could take as many as eight years to switch partners. 

Politico Pro (7/3/2024): Senate to kick off fiscal 2025 markups next week - The Senate will begin marking up annual spending bills next week, starting with three fiscal 2025 measures and overall funding totals for a dozen appropriations bills. Bypassing subcommittee markups, the full Senate Appropriations Committee will take up its Legislative Branch, Military Construction-VA and Agriculture-FDA spending bills on July 11, in addition to a dozen subcommittee allocations known as the 302(b)s. Like last year, Senate Democrats and Republicans have not reached an agreement on overall funding levels for 12 appropriations bills, and the numbers will likely pass the committee along party lines. The spending bills that flow from those totals, however, are expected to pass the committee with bipartisan support. The committee approved a dozen appropriations bills last summer for the first time in five years under the leadership of Senate Appropriations Chair Patty Murray (D-Wash.) and ranking member Sen. Susan Collins (R-Maine). Six bills — including the Commerce-Justice-Science, Interior-Environment, Energy-Water, Labor-HHS-Education, Transportation-HUD and Agriculture-FDA measures — are headed for full committee markups next week, while GOP leaders in the lower chamber aim to pass their Legislative Branch funding measure on the floor. House Republicans have so far passed their Military Construction-VA, Defense, State-Foreign Operations and Homeland Security bills on the floor, pursuing an ambitious plan to approve all 12 before the August recess.

Stat (7/3/2024): Can the National Institutes of Health navigate multiple storms and rebuild its bipartisan support? - Few federal agencies have enjoyed a more sterling reputation on Capitol Hill over the past several decades than the National Institutes of Health. But a bevy of challenges are spurring calls for reform on Capitol Hill that may be difficult for the agency to fend off without making some concessions. The reputation of the NIH, coupled with excitement about the agency’s role in advancing discoveries to improve health, made possible a doubling of the agency’s budget that concluded 20 years ago. Many members of Congress remained sympathetic to the agency’s challenges during the ensuing period of flat or declining budgets, particularly Republicans, who are typically less supportive of non-defense or security domestic spending. Over the past decade, the agency’s standing — and its cadre of well-positioned congressional backers — resulted in multiple years of sizable growth, helping recoup ground lost following the doubling bust. Unfortunately for the NIH and its extensive universe of influential external stakeholders, including universities, academic medical centers, nonprofit patient advocacy groups, and the medical products industry, the agency is finding itself navigating a perfect storm of challenges. In addition to these challenges, calls for substantive changes to the NIH are being aired by influential leaders in Congress, notably the top Republicans on the two committees with oversight authority over the agency, the House Energy & Commerce and the Senate HELP panels.

Stat (7/2/2024): Making sense of the debate’s health care debate - I know, no one wants to talk about the first 2024 presidential debate. But we’ve got post-debate polls, Democratic tension and real questions about where the race, and the conversation around health care policy, go from here. From “we finally beat Medicare,” to abortion rights, health programs’ solvency, and high drug prices, there was a surprising amount of health care debate Thursday night — but little of it substantive, or accurate. The president stumbled explaining his two most popular campaign talking points: Protecting abortion rights and lowering prescription drug costs. Biden was garbled when explaining Roe’s framework and erred multiple times as he talked about landmark legislation to negotiate drug prices and cap insulin costs.

Politico Pro (6/28/2024): Chevron's demise could stall FDA rulemaking, former officials say - Former FDA attorneys fear it will take longer to develop new drugs and medical devices now that the Supreme Court has gutted the so-called Chevron deference. FDA decision-making is likely to slow as well, they said. The good news: The high court’s overturning of the Chevron deference doctrine likely won’t call into question the FDA’s individual product decisions because that authority is grounded in statute, former commissioners and agency lawyers said. But the process by which the FDA reaches decisions could fall under greater scrutiny, they said, leading to more lawsuits and potentially longer lead times for agency decisions as government lawyers work to shore up their legal standing. “The agency is really going to have to build in a lot more explanation of why it comes to the decisions that it does,” said Jerry Masoudi, a partner at Covington & Burling and former FDA chief counsel. “Instead of showing it’s being reasonable, it will have to write a decision that has the power to persuade a court that it’s right.” Regulations like the FDA’s recent final rule sweeping laboratory-developed tests under its purview are particularly vulnerable. “That's a good example of the type of case where Chevron could make a difference,” said Aetion senior adviser Lowell Schiller, who previously served as acting FDA chief counsel and principal associate commissioner for policy. “Hard to say at this point whether that will be an outcome-determinative difference, but where the agency is interpreting the scope of its own authorities — what it means to be practicing medicine — perhaps that could make a difference.” Beyond the FDA, the Chevron opinion also may open President Joe Biden’s landmark Medicare drug price negotiation program to new challenges.

Politico Pro (6/27/2024): Title X cuts, NIH reorganization among Democrat holdups in HHS appropriations - A House subcommittee advanced legislation Thursday to slash the budget of the Department of Health and Human Services in fiscal 2025 by 7 percent, reorganize the department’s research arm and eliminate some programs. The legislation advanced in a voice vote along party lines, but members on both sides of the aisle acknowledged the bill is unlikely to pass in its current form. Democrats said they’ll fight against the bill’s cuts to family planning funding under Title X and the reorganization of the NIH. And Republicans argued that the cuts are fiscally responsible and pushed back on what they call President Joe Biden’s “progressive” agenda. The legislation — approved at the Appropriations Labor, Health and Human Services, Education and Related Agencies Subcommittee markup — would cut HHS funding 7 percent, streamline and trim NIH operations and end certain programs, including ones on gun violence and climate change.

CNN (6/26/2024): US cancer centers warn drug shortages continue, impacting different varieties of medications – While a shortage of the chemotherapy drugs cisplatin and carboplatin has improved in the United States, some of the nation’s largest cancer centers now report additional concerns related to drug shortages, a new report finds.Among 28 large cancer centers across the country, 89% reported last month that at least one drug used to either treat cancer, its symptoms or the side effects of treatment was in short supply at their center, according to new survey results released Wednesday by the National Comprehensive Cancer Network. That percentage has not changed much from last year, when about 86% of surveyed centers reported a shortage of at least one type of anti-cancer drug. But what has changed is specifically which cancer drugs are impacted. The new NCCN survey, conducted from May 28 to June 11 of this year, found that among 28 of the network’s 33 cancer centers, more than half — 57% — reported a short supply of the chemotherapy drug vinblastine, which is often used in combination with other chemotherapy drugs to treat Hodgkin’s lymphoma, non-Hodgkin’s lymphoma, and cancer of the testicles.

Politico Pro (6/26/2024): HHS’ appropriations bill slashes CDC, reforms NIH – Funding for the Department of Health and Human Services could see a 7 percent cut for fiscal year 2025 under an appropriations bill Congress is considering — with some of the biggest changes made to the CDC and the NIH. The spending plan includes $107 billion for HHS — $14 billion less than what President Joe Biden has asked for in 2025, and an $8.5 billion cut from the 2024 budget. The appropriations bill released Wednesday has many Republican-backed proposals to strip programs within HHS they believe are “social engineering,” or programs focused on issues like climate change and LGBTQ+ health. Under the legislation, CDC programs focused on gun research and climate change would disappear and the NIH would undergo a restructuring. Also, it would prevent HHS from funding certain regulations it finalized in recent months, including mandating minimum staffing levels in nursing homes, expanding nondiscrimination protections in health care for LGBTQ+ patients and says HHS cannot use any funding for gender-affirming care. The House Appropriations Committee will markup the bill on Thursday.

Politico Pro (6/26/2024): FDA releases draft guidance for trial diversity plans – The FDA released long-awaited draft guidance Wednesday describing how drug and device companies should approach enrolling clinical trial participants to ensure greater diversity and improve the quality of their data. The guidance outlines when and how trial sponsors must submit diversity action plans for those studies that include enrollment goals to improve the participation of "underrepresented populations" — and how those goals will be met. "Underrepresented populations" include people of various races, ethnicities, age groups and sexes, as well as pregnant or lactating individuals, according to the guidance. The agency also encouraged drug and device makers to consider other factors that can lead to health disparities, such as geographic location, socioeconomic status, gender identity, and physical and mental disabilities. Congress required the agency to write the guidance in its 2022 update to the user fee law that helps fund FDA reviews of drug applications. Lawmakers have pressed the agency to release the document, which was supposed to be published in December under the law. The FDA will take public comment on the guidance for 90 days after it's published in the Federal Register. Manufacturers will be required to submit diversity action plans for certain studies in which enrollment begins 180 days after publication of the finalized guidance.

Politico Pro (6/26/2024): A look at E&C’s telehealth legislation ahead of key markup - An amended version of telehealth legislation would extend eased virtual care rules for two years and includes several offsets. The new text, obtained by POLITICO, comes in advance of a Thursday markup and appears to attempt to address a pledge by Chair Cathy McMorris Rodgers (R-Wash.), who said the committee would advance legislation that would be fully paid for. Addressing the cost is key to getting the telehealth legislation to the finish line. The offsets include changing the phase-in of Medicare clinical laboratory test payment modifications. The legislation — from Rep. Buddy Carter (R-Ga.) — would also add a number of transparency requirements for pharmacy benefit managers and hospital outpatient departments. Changes could be made to this version of the Telehealth Modernization Act. The E&C health subcommittee had approved a version of the measure last month but delayed a full committee markup. Congress has been weighing the future of telehealth as eased pandemic-era rules in Medicare expire at the end of the year. The Ways and Means Committee unanimously advanced similar legislation last month.

The Hill (6/23/2024): Joe Biden’s ‘Cancer Moonshot’ may be derailed by new policies, including his own – For almost a decade, President Biden has championed a bold “cancer moonshot” — an initiative he first launched in 2016, revived early in his administration, and reiterated during this year’s State of the Union. It is a laudable goal, especially for an aging nation where cancer and chronic disease are on the rise. There’s just one problem: Recent federal and state policies are poised to derail the incredible progress made in oncology since 2016. By many measures, the “cancer moonshot” is already here. Between 2017 and 2022, the U.S Food and Drug Administration issued 161 new approvals for cancer therapeutics across a range of indications. This includes T-cells tailored to patients’ unique biological makeup. However, a rash of policies now threatens to limit access and slow progress towards new breakthroughs. While Biden vowed to “end cancer as we know it” with innovative projects like the Advanced Research Projects Agency for Health, he has also doubled down on his commitment to initiatives — such as the Medicare Drug Price Negotiation Program within the Inflation Reduction Act — which would stunt medical innovation at a time when we need just the reverse.