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Politico Pro (3/1/2024): Docs eye pay bump as health package talks progress – The Senate cleared a stopgap funding bill Thursday night for President Joe Biden’s signature, buying more time to finalize half a dozen spending bills that congressional leaders aim to pass next week. With the immediate threat of a government shutdown averted — for now — jockeying has begun for the packages that will fund key agencies, including the FDA and HHS, through September. Doctors’ groups are focused on the congressional talks to mitigate the cut to their pay from Medicare, which have advanced this week, Megan, Robert and Daniel report. Five lobbyists said they believe a pay bump — between 1.25 percent and 1.75 percent — could be in order. That proposal would still leave much of the 3.4 percent cut in effect. Lobbyists said a deal on the amount is close to being done. “The number has bounced around a bit during negotiations, in part as a trade-off for the size of the package, and in particular the size of the community health center provisions,” said Dean Rosen, a partner at Mehlman Consulting who’s been working on the issue. “With the leadership reaching an agreement on the broader spending framework, work has accelerated over the last 24 hours on the healthcare package.”

But “the health package is still under negotiation,” a spokesperson for Senate Majority Leader Chuck Schumer told Daniel in an email.

Politico Pro (2/29/2024): Senate sends government shutdown patch to Biden’s desk – The Senate approved a stopgap funding bill Thursday night for President Joe Biden’s signature, thwarting a partial government shutdown on Saturday and buying more time to finalize half a dozen spending bills that congressional leaders aim to pass next week. Congress now officially has until March 8 to clear that initial six-bill bundle, which leaders struck a deal on earlier this week. But they're still working on an agreement to fund the rest of the government, including the military and some of the biggest domestic programs, before a second deadline on March 22. The upper chamber cleared the measure in a 77-13 vote, following votes on four Republican amendments that were defeated on the floor. Appropriators are optimistic that this latest stopgap — the fourth enacted by Congress this fiscal year alone — will finally deliver enough time to wrap up funding negotiations after a particularly chaotic cycle largely derailed by House Republican infighting. If congressional leaders can successfully pass the six bills next week to fund the departments of Agriculture, Energy, Veterans’ Affairs and Transportation, they’ll face an even bigger test in trying to strike a compromise on the remaining six bills that fund the rest of the federal government.

Politico Pro (2/28/2024): Here’s what’s in the stopgap funding bill for health care - Lawmakers agreed Wednesday on a stopgap measure to fund the government later into March and extend funding for health agencies. The continuing resolution would push back the dual set of deadlines for funding bills to March 8 for those covering the FDA and VA, and March 22 — the beginning of Easter recess — for the tranche of bills including HHS, which has proven more contentious. Lawmakers came to an agreement on the bills covering the FDA and VA, and Congressional leaders aim to release text by this weekend and fund those agencies through September next week. Lawmakers have until midnight Saturday to vote on this latest agreement and avoid a partial shutdown. If that doesn’t happen, funding for the FDA and VA will expire. HHS funding expires March 8 as does money for community health centers, special diabetes programs, teaching health centers and the National Health Service Corps. Provisions avoiding steep cuts to hospitals that have a high volume of Medicaid and uninsured patients also sunset then. The legislation doesn’t address the myriad expired health programs that Congress still must reauthorize, including the global HIV/AIDS program, PEPFAR; the SUPPORT Act, which tackles the opioid epidemic; and the Pandemic and All-Hazards Preparedness Act. It also doesn’t include a deal on pharmacy benefit manager reform, with lawmakers at an impasse.

Politico Pro (2/26/2024): Overhaul of pharmacy middlemen flounders despite bipartisan support - Bipartisan legislation to overhaul how pharmacy benefit managers operate is in flux after negotiations broke down over the scope of the reforms, according to seven lobbyists and two congressional aides granted anonymity to discuss the talks candidly.

PBMs are middlemen who negotiate drug purchases on behalf of insurers and decide which medicines an insurance plan will cover. Drugmakers have funded major advertising and lobbying campaigns to convince Congress that PBM practices are to blame for the high prices patients face at the pharmacy. Community pharmacists have raised similar concerns and lawmakers of both parties agree there’s a problem. The House would mandate more transparency of how PBMs operate in the Lower Costs, More Transparency Act that it passed overwhelmingly in December. The Senate HELP Committee last May approved legislation 18-3 that would go further, requiring PBMs to pass along drug rebates they receive to commercial health insurance plans and banning “spread pricing” in which PBMs charge insurers more for drugs than what they are reimbursed by pharmacies. And the Senate’s Finance panel in November unanimously approved a bill that would limit what Medicare enrollees pay for some drugs and require HHS to lower drug costs, partly by “de-linking” how much PBMs profit from the list price cost of a drug. Lawmakers haven’t been able to reconcile the different approaches, with House members rejecting the specific reforms in both Senate bills, according to lobbyists.

Politico Pro (2/26/2024): Looming budget cuts are keeping the new NIH director up at night - The new director of the National Institutes of Health, Dr. Monica Bertagnolli, is grappling with a proposed fiscal 2024 budget so tight that it could force her to reduce the grants that seed medical innovation at American research universities. With a March 8 funding deadline approaching, the Republican-controlled House has proposed an 8 percent, $3.8 billion budget cut to the $48 billion NIH got last year, while the Democrat-controlled Senate wants to keep the agency's funding almost flat, offering a $265 million bump. Those figures concern Bertagnolli, she told POLITICO during a sit-down Wednesday in her office on NIH's Bethesda campus. A sizable budget cut or keeping it flat would also mark a major change in direction for the agency that helps fund and develop many life-saving drugs and vaccines. NIH funding has risen consistently year-over-year in recent years, by an average 5 percent over the past decade. "I know the last time NIH saw significant funding cuts we lost a generation," Bertagnolli said, referencing budget cuts during the federal spending war between President Barack Obama and the Republican-controlled House in 2013. She added: "The funding level of grants goes down. Junior people see this. They decide: ‘Why would I go into biomedical research? I won't be able to have a stable job.’ They move away from this field."

Politico Pro (2/23/2024): EPA air rule pits public health against medical devices - A looming EPA air regulation aimed at stanching industrial releases of a carcinogenic gas is pitting several of the Biden administration’s most prominent public health priorities against each other. The regulation would limit emissions of ethylene oxide — an odorless, colorless gas linked with breast cancer and white blood cell cancer in people who face chronic exposure — from facilities that use it to sterilize medical devices. Nearly 13 million people live near these facilities, which pose a disproportionate risk to low-income and minority communities, according to an analysis by the Union of Concerned Scientists. The Biden EPA has made addressing the potent pollutant a key part of its environmental justice work. But the medical device industry argues that the nation’s 86 sterilization facilities are working at full tilt to keep hospitals and doctors’ offices supplied with everything from surgical kits to devices used in open-heart surgery. The industry and its federal regulator, the Food and Drug Administration, have warned that the stringent rules EPA proposed last spring would force facilities offline for upgrades, potentially disrupting supply chains and cutting off access to lifesaving equipment. The new regulation is due out March 1 under a court settlement and is currently undergoing review at the White House. Both environmental and industry advocates say that the prospect of medical supply chain problems is raising major concerns among White House policy staffers.

Bloomberg (2/21/2024): GOP Exodus Opens Key Roles in Health Policy - A House panel with jurisdiction over health care policy faces a GOP leadership shakeup in 2025, with multiple Republicans expected to compete for the top spot in the wake of Chairw Cathy McMorris Rodgers’ (Wash.) decision to retire from Congress next year. Reps. Bob Latta (Ohio) and Brett Guthrie (Ky.), the most senior Republicans on the committee, have emerged as the leading contenders for the chairmanship or ranking member spot of the Energy and Commerce Committee, depending on which party wins the House majority in November. Yet Republicans don’t determine committee leadership solely based on seniority, easing the way for dark horse candidates to come forward. The jockeying mirrors a dynamic across the conference, as experienced, policy-focused Republicans bail out amid the dysfunction and intraparty fighting that have plagued the House since the party took over the majority. The resulting committee, subcommittee, and conference leadership vacancies would allow ambitious members to take a shot at climbing the House ladder. But long-serving members warn of a brain drain if Republicans replace their policy wonks with greener lawmakers who are more interested in politics than policy.

Bloomberg (2/21/2024): Lawmakers Probe Teva, Pfizer, Sandoz on Medication Shortages - Democrats on the House Oversight Committee request a briefing and information from TevaPfizer, and Sandoz related to ongoing shortages of cancer drugs, amoxicillin and stimulant medications like Adderall, in letters to company leaders. Lawmakers request information related to shortages no later than March 6 to help determine root causes and solutions

Bloomberg (2/20/2024): GOP Eyes Hearing to Spotlight IRA’s Pitfalls - The House Energy and Commerce Committee is looking at holding a health care hearing toward the end of the month that could examine some of the drug pricing provisions in the President Joe Biden’s Inflation Reduction Act, three people familiar with the discussions told Bloomberg Government. Details are still being ironed out, but people expect it to focus on the rare disease provisions of the IRA. Some cancer policy bills may also be on the table. Rare-disease advocates, the biotech sector, and others have been working to address what they feel are shortcomings in both the Biden administration’s interpretation of the landmark law and the program itself, which lets the Medicare agency negotiate prices directly with drug makers for the first time in history.

The Inflation Reduction Act exempts orphan drugs from price negotiations if the FDA has only approved them to treat “only one rare disease or condition” and “for which the only approved indication (or indications) is for such disease or condition.” Since the FDA must issue the orphan drug designation before a company submits an application to approve a drug, there are concerns drugmakers will stop testing rare-disease drugs to see if they can work on new therapies as those drugs will be subject to Medicare negotiations. Alnylam halted work in 2022 to study whether an approved therapy could treat a rare eye disease, citing the Inflation Reduction Act. The hearing will likely fall on or near Rare Disease Day, which is Feb. 29 this year, capping a busy month for the committee on health policy.

Politico Pro (2/16/2024): FDA approves first cell therapy for solid tumors - The FDA Friday granted accelerated approval to the first cell therapy for solid tumors. The agency approved Iovance Biotherapeutics' Amtagvi to treat advanced melanoma that either can't be removed from the body or has spread throughout the body and was previously treated with other therapies. Amtagvi uses T-cells extracted from a patient's tumor tissue that are then used to create healthy T-cells, which are infused back into the patient. CAR T-cell therapies already on the market are approved to treat certain blood cancers, making Amtagvi a first-in-class treatment. “The accelerated approval of AMTAGVI™ is the first step in realizing Iovance’s ambition to usher in the next generation of cell therapy by bringing this breakthrough to patients with advanced solid tumors,” said Frederick Vogt, the company's president and interim CEO.

Politico Pro (2/14/2024): Wait till next year on Medicare doctor pay reform, lawmakers say
- Congress could still rescind a recent 3.4 percent cut to the rates Medicare pays doctors. But don’t expect any broader reform of the formula that has repeatedly forced lawmakers to stave off reductions in doctor pay. An election-year slowdown in legislative activity will likely forestall action, House members told disappointed doctors attending the American Medical Association conference in Washington today. “I think I’m just being honest: It has a better chance in 2025 when there’s a new Congress, just because it’s a presidential election [year],” said Rep. Robin Kelly (D-Ill.), a member of the Energy and Commerce Health Subcommittee and the co-sponsor of a reform bill. Rep. Ami Bera (D-Calif.) also cautioned AMA members not to get their hopes up. “It’s going to be difficult,” he said. Both Kelly and Bera said lawmakers’ priority in the short term is stopping at least part of the cut that took effect Jan. 1.

Bloomberg (2/14/2024): FTC Examining Shortages of Cancer Treatments and Other Drugs - The Biden administration is seeking public comment on shortages of cancer treatments and other drugs related to the role that middlemen play in the pharmaceutical supply chain, the US Federal Trade Commission said Wednesday. In a joint request for information by the FTC and Department of Health and Human Services Wednesday, the federal government asked about shortages of generic drugs and whether groups that purchase quantities in bulk are contributing to the problem. “Our inquiry requests information on the factors driving these shortages and scrutinizes the practices of opaque drug middlemen,” FTC Chair Lina Khan said. The inquiry is targeting two types of middlemen. Group purchasing organizations like HCA Healthcare Inc.’s HealthTrust, Premier Inc. and Vizient Inc. buy large quantities of drugs on behalf of hospitals and health systems. Pharmaceutical distributors or wholesalers like McKesson Corp.Cardinal Health Inc. and Cencora Inc., formerly known as Amerisourcebergen buy drugs from pharmaceutical manufacturers and sell them on to pharmacies, nursing homes and health care providers.

Bloomberg (2/14/2024): Ads Target ‘Pill Penalty’ Bill’s Dem Sponsor - The lone Democrat behind a drug pricing bill favored by the pharmaceutical industry faces attacks from an influential drug pricing group on accusations he’s backtracking on promises he made to patients. Patients For AffoRep. Greg Murphy (R-N.C.) introduced the bill earlier this month along with Davis and Rep. Brett Guthrie (R-Ky.), who is the chair of the Energy and Commerce Health Subcommittee. “The voters in Congressman Davis’ district need to know that he reneged on his campaign promise to stand up to drug companies and is sponsoring legislation that, if enacted, would weaken Medicare’s ability to negotiate and lead to higher prices,” David Mitchell, founder of P4ADNow said in a statement. The ad campaign started yesterday, P4AD said. Davis, who’s currently serving his first term in Congress, is running for reelection in a key swing district that could impact who controls Congress in November. The Republican legislature in North Carolina redrew the northeastern 1st district last year be more politically competitive, Greg Giroux reports. The Carolina Journal described Davis’s district as the state’s “only competitive congressional district.” The bill would give all drugs the same amount of market time before they’re subject to Medicare negotiation. The current program exempts small molecule drugs from negotiations until nine years after their approval date. More complex biologics are exempt until 13 years after approval, similar to the longer market exclusivity the FDA grants for biologics. The industry has complained about this four-year difference as a “pill penalty.”

Politico Pro (2/14/2024): Bishop: Ag-FDA bill working through several ‘sticky’ issues - The top Democrat on the House Appropriations Agriculture Subcommittee said there are a handful of sticking points holding up the Agriculture and Food and Drug Administration spending bill, which will likely need to be moved up to leadership-level negotiations. “There are probably around three or four issues that are sticky that will have to be resolved,” Rep. Sanford Bishop (D-Ga.) said in a brief interview. “Of course, when they get to an impasse, they’re going to have to bump them up.” The delays in the Ag-FDA spending bill talks are concerning lawmakers, some of whom have noted that negotiations over some other key funding bills are finished or close to being finalized ahead of the March deadlines. Other controversial bills are also experiencing issues, according to lawmakers. But the Ag-FDA legislation is traditionally one of the least controversial appropriations bills lawmakers tackle every year.

Politico Pro (2/12/2024): Court dismisses PhRMA-backed lawsuit against Medicare price negotiations - A federal court on Monday dismissed a lawsuit challenging Medicare drug price negotiations backed by the Pharmaceutical Research and Manufacturers of America, ruling that it was filed in the improper venue. “The Court lacks jurisdiction over [the National Infusion Center Association’s] claims because the claims here ‘arise under’ the Medicare Act and the claims do not fall under the exception carved out for when claims may completely avoid judicial or administrative review,” Senior District Judge David Alan Ezra wrote. “Therefore, NICA’s claims are dismissed without prejudice.” Experts say it’s too early to tell whether the ruling might impact the eight other federal lawsuits filed in an effort to halt the first Medicare drug price negotiations. “We are disappointed with the court’s decision, which does not address the merits of our lawsuit, and we are weighing our next legal steps,” PhRMA spokesperson Nicole Longo said. “Today’s ruling offers more reason for optimism that our work driving down the cost of prescription drugs will build,” HHS Secretary Xavier Becerra said in a statement. “We will continue to implement the President’s historic prescription drug price law, which is already delivering for the American people.” Nicholas Bagley, a law professor at the University of Michigan, said it is noteworthy that the judge dismissed the lawsuit without a hearing..

Sen. Cortez-Masto PR (2/9/2024): CORTEZ MASTO, BLACKBURN, THUNE, BARRASSO, STABENOW, WARNER ANNOUNCE FORMATION OF MEDICARE PAYMENT REFORM WORKING GROUP -
U.S. Senators Catherine Cortez Masto (D-Nev.), Marsha Blackburn (R-Tenn.), John Thune (R-S.D.), John Barrasso (R-Wyo.), Debbie Stabenow (D-Mich.), and Mark Warner (D-Va.) today announced the formation of a Medicare payment reform working group. The primary goal of this group is to investigate and propose long-term reforms to the physician fee schedule (PFS) and make necessary updates to the Medicare Access and CHIP Reauthorization Act (MACRA).

To Interested Parties: As the health care system has evolved since the inception of the Medicare program, the physician payment system has failed to keep pace with the actual cost of care and the improvements in new services and technologies. Medicare Part B is a lifeline for tens of millions of Americans, covering a wide array of services, including primary and outpatient care, preventive services, durable medical equipment, and more. Despite efforts like the 2015 Medicare Access and CHIP Reauthorization Act (MACRA), which made significant strides towards a value-based payment system, further action is needed to address reimbursement challenges and shift toward a system that aligns payment incentives with patient outcomes. We believe Congress must make changes to the current Medicare physician payment system to ensure financial stability for providers, improve patient outcomes, promote access to quality care, and incentivize the utilization of emerging health care technology. Today, we are beginning work as a bipartisan working group to help achieve these goals and put Medicare on a sustainable path for the future. This working group is committed to exploring and proposing policy solutions for stable physician payments and necessary updates to MACRA, ensuring sustained access to quality care for patients. We will be reaching out to stakeholders in the coming weeks to seek feedback and to begin developing policies that will address Medicare physician payment for the long-term.

Politico Pro (2/8/2024): E&C Chair McMorris Rodgers announces retirement - House Energy and Commerce Committee Chair Cathy McMorris Rodgers will not run for reelection. The Washington state Republican — who leads a powerful committee with oversight of health care and energy policy — is the latest member to announce plans to retire. "We will spend this year honoring the Committee's rich history — plowing the hard ground necessary to legislate on solutions to make people's lives better and ensure America wins the future," McMorris Rodgers said in a statement. McMorris Rodgers, who has been in Congress since 2005, was instrumental in negotiating a five-year reauthorization of the FDA's user fee program. She also worked with ranking member Frank Pallone (D-N.J.) to co-author a major consumer privacy bill last Congress. Rep. Brett Guthrie (R-Ky.), the current chair of the health subcommittee, is vying to replace her. “He’s running,” Guthrie spokesperson DJ Griffin said. Rep. Bob Latta of Ohio, who will be the most senior Republican on E&C next Congress, is running for chair of Energy and Commerce, per two people with knowledge of the matter. Rep. Richard Hudson of North Carolina, chair of the National Republican Congressional Committee, is also being encouraged to run for the top committee role, according to two high-level Republicans familiar with the matter. If he ultimately did launch a bid, that would mean Hudson would forgo seeking another term in leadership.

Politico Pro (2/8/2024): Sanders, Dems slam pharma CEOs for drug prices, profits at hearing - The CEOs of three major pharmaceuticals appeared before Congress Thursday to receive a tongue lashing from Sen. Bernie Sanders (I-Vt.) over their high-priced drugs, but they weren't ready to commit to new drug price cuts. The HELP Committee hearing was more theater than a forum to discuss pending legislation with the participants sticking to familiar scripts. Democrats pushed drugmakers to care more about patients than profits and Republicans touted the benefits of a market-driven system that produces blockbuster lifesaving drugs. When the leaders of Johnson & Johnson, Merck and Bristol Myers Squibb were asked to commit to cutting prices, they demurred. "The outrageous cost of prescription drugs in this country means that 1 out of 4 Americans cannot afford the medicine their doctors prescribe," Sanders, who chairs the committee, said. "How many die and how many suffer unnecessarily, nobody knows but my guess is that it’s in the millions." Why are U.S. prices so high? The CEOs acknowledged affordability challenges, asked that discounts won by the middlemen of pharmacy benefit managers be passed on to patients and urged Congress to protect the U.S. biopharmaceutical industry from an economic environment that hinders the discovery of new medicines. “We have a role to play in addressing affordability and stand ready to partner with Congress and others to address this issue for patients in a holistic manner, but in developing those solutions, we should not abandon our system for one that denies U.S. patients the broad and rapid access to vital medicines that they appreciate today,” Bristol Myers Squibb CEO Chris Boerner said. Sanders told POLITICO that he plans to introduce new drug-pricing legislation soon, but declined to give any details. He said the drugmakers’ comments reining in drug prices were “certainly not enough.”

Politico Pro (2/6/2024): Ways and Means takes its turn on drug shortages - A key question behind chronic drug shortages is what policy levers Congress could use to mitigate Americans not being able to get the drugs they need. The problem is acute for lower-priced generics with manufacturers blaming supply-chain issues and innumerable regulations. In a hearing Tuesday, House Ways and Means Chair Jason Smith (R-Mo.) floated changes to Medicare reimbursement policy to address pervasive drug shortages. “Government policies and consolidation in the supply chain force manufacturers to close drug production because they can’t make the math work,” Smith said. “Medicare’s reimbursement system ensures affordability and access for seniors, but should be reexamined to avoid making the situation worse.” Smith didn’t offer details about what changes are needed. He also raised concerns about relying too much on foreign countries like China for the drug supply chain. Smith pointed to private-sector solutions like long-term contracts and state investments. He said “health care, tax and trade policy” should be used to boost domestic manufacturing. Ranking member Richard Neal (D-Mass.) also pointed the finger at supply-chain dynamics, citing exclusive contracts with just one manufacturer in particular. He touted Biden administration actions to boost domestic production, such as leaning on the Defense Production Act, and said cost remains an access issue, hammering Republicans for not supporting the Inflation Reduction Act that launched the first Medicare drug price negotiations.

Executives from McKesson Pharmaceutical Solutions & Services, nonprofit generic drug firm Civica Rx and the American Society of Clinical Oncology testified Tuesday, among others.

Politico Pro (2/6/2024): House GOP lawmakers slam FDA no-show at hearing - A House subcommittee hearing Tuesday on foreign inspections of drugmakers was overshadowed by a lawmaker-agency dustup over why the FDA wasn’t there to testify. Virginia Republican Morgan Griffith, chair of the Energy and Commerce Oversight and Investigations Subcommittee, told POLITICO the FDA had been invited to appear about two weeks ago, but an FDA spokesperson said it did not receive an invitation that was "timely or formal." “We understand the importance of our foreign inspection program to the health and safety of the American public and the agency has been responsive to the Committee’s inquiries on this issue,” FDA spokesperson Jeremy Kahn wrote in an email. “We will continue to engage with any specific questions they have on this or related topics.” "Completely unacceptable," Energy and Commerce Chair Cathy McMorris Rodgers (R-Wash.) said at the hearing. CJ Young, a spokesperson for the Democrats on the Energy & Commerce committee, said in an email that Republicans’ complaint about the FDA’s no-show represents an effort to score political points. “The [GOP] majority chose to informally notify FDA about this hearing without sufficient notice to attend," Young said, noting that three weeks notice is standard practice on most congressional committee invites to federal agencies. “A week is not unreasonable to send a representative," Griffith said. “If we expect to get the head guy, we probably need to give them a little bit more time. But to get somebody here to discuss it, two weeks is plenty.” Griffith said the committee plans to hold additional hearings on FDA’s foreign inspection program — and urged the agency to testify. Regardless, lawmakers on both sides of the aisle said the FDA must do a better job boosting the number of in-person inspections in countries like China and India, which supply about 45 percent of the active pharmaceutical ingredients used in the nation’s drugs, according to a  letter from the committee sent to the FDA in July.

Bloomberg (2/2/2024): Biden Will Send Congress His 2025 Budget Proposal on March 11 - President Joe Biden will send lawmakers his fiscal 2025 budget proposal March 11, days after his State of the Union address and a deadline to avoid a shutdown, White House Office of Management and Budget staff exclusively told Bloomberg Government. Biden’s March 11 budget plan follows fiscal 2024 funding deadlines on March 1 and March 8 and the president’s annual address to Congress, scheduled for March 7. It will cap a frantic few days with lawmakers likely racing to finish this year’s government-funding bills — more than five months late — before quickly turning to fiscal 2025 negotiations. Lawmakers already acknowledged the late start, combined with election-year politicking, will make it difficult to make much progress on appropriations bills ahead of the Sept. 30 funding deadline. The budget proposal is technically due the first Monday in February, though presidents rarely met that deadline in recent years.

Politico Pro (2/1/2024): Health AI rule hits a snag - An HHS rule finalized in December that would require more transparency in artificial intelligence now faces potential delays. The rule, published on Jan. 9, is in limbo because HHS' Office of the National Coordinator for Health IT did not allow sufficient time after transmitting it to Congress before finalizing it. A 1996 law requires agencies to wait 60 days, but ONC finalized the rule about a month after it went to Congress, according to the Government Accountability Office. The rule is to go into effect at the end of 2024. It’s unclear whether the snafu will delay implementation. An ONC spokesperson said the agency is “aware of the 60-day requirement and … working to address the discrepancy.” The spokesperson didn’t answer questions about a potential delay. The sweeping ONC regulations will apply to clinicians using HHS-certified decision support software that’s used in the vast majority of hospitals and doctor’s offices. It would fill a substantial void in regulation and intends to help providers choose safer artificial intelligence. The regulations will require software developers to provide more data to customers to allow providers to determine whether AI is “fair, appropriate, valid, effective and safe.”