Other Regulatory News

Centers for Medicare and Medicaid Services (CMS)

This health tech exec is in charge of Medicare, and he has big ambitions

In keeping with the Trump administration’s quest to slash spending at the federal health department, it’s hired a famously thrifty technology entrepreneur to lead Medicare.

As the CEO of health IT company Collective Medical, Chris Klomp flew bargain-priced Frontier Airlines and once boasted about sleeping in rental cars and crummy motels on business trips.

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ACO REACH Misses Target In Serving High-Risk Groups

In its first year, Medicare’s Accountable Care Organization Realizing Equity, Access, and Community Health (ACO REACH) model fell short of enrolling providers that serve patients with high social risks, according to a new study published in JAMA Health Forum.

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CMS explores limiting insurers’ use of prior authorizations

Leaders at the Centers for Medicare and Medicaid Services are exploring proposals to limit health insurers’ use of tactics that can delay medical care, people familiar with the discussions said.

The aim of the proposals would be to cut the number of medical procedures subject to “prior authorization,” meaning ones in which doctors have to fill out additional paperwork for ultimate approval. CMS is exploring making policies more uniform across different health insurance plans.

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GAO: Inflation Reduction Act of 2022: Initial Implementation of Medicare Drug Pricing Provisions

The Centers for Medicare & Medicaid Services (CMS) has begun implementing the Medicare drug price negotiation program (negotiation program) and Medicare prescription drug inflation rebate program (inflation rebate program), as the Inflation Reduction Act of 2022 (IRA) requires. As of December 2024, CMS plans to obligate approximately $2.9 billion of the $3 billion in negotiation program appropriated funds from fiscal years 2022 through 2033. CMS plans to use the majority—85 percent—of actual and planned obligations for program support—including contractors to support access to negotiated prices by pharmacies and other dispensing entities—and administration.

#Drug, #Patient

Supreme Court rules against hospitals in DSH case

In the 7-2 decision on Advocate Christ Medical Center v. Kennedy announced Tuesday, the high court determined the CMS does not need to count all beneficiaries enrolled in both Medicare and Supplemental Security Income when tallying how many low-income patients a hospital treats. As a result, health systems will get paid less than they sought. CMS only counts Medicare enrollees who got SSI cash payments during the same month they received hospital care — not anyone merely eligible for or enrolled in SSI — when calculating disproportionate share hospital payments for facilities that treat large shares of low-income patients.

#Hospital

Opinion: The Hospital Financial House of Cards Is Crumbling

Many hospitals are already failing financially as evidenced by rural hospitals closing programs, filing for bankruptcy, or closing outright. Urban safety-net hospitals are also being impacted with many — if not most — operating in the redopens in a new tab or window. And yet, Congress is considering cuts to Medicaid and a variety of supplemental reimbursement programs that would be catastrophic. This will only be exacerbated by tariffs driving up costsopens in a new tab or window, unfunded mandates from the states and federal government, and over-regulation of health facilities.

#Hospital

Justice Department sues Medicare Advantage insurers and brokers, alleging kickbacks

The Department of Justice has sued three of the largest Medicare Advantage insurers and three dominant insurance brokerages, alleging a scheme in which the health insurers bribed the brokers to steer older adults into their policies. The lawsuit targets CVS Health’s Aetna, Elevance Health’s Anthem, and Humana, which together cover nearly 40% of the Medicare Advantage market. The brokers named in the lawsuit are eHealth, GoHealth, and SelectQuote.

#Payer, #Patient

Food and Drug Administration (FDA)

A Conversation With FDA Commissioner Marty Makary

In a Q&A piece, FDA Commissioner Marty Makary provides his impressions of the early days of his tensure and shares his vision for FDA.

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Study: Data lacking for AI-enabled medical devices cleared by FDA

Clinical performance data for medical devices with artificial intelligence (AI) features is often unavailable, making it difficult to assess real-world outcomes and potentially jeopardizing safety, according to a new study of products cleared by the US Food and Drug Administration (FDA).

The study looked at 903 products, the majority of which were used in radiology applications (76.6%). Clinical performance studies were available for a little more than half (505, or 55.9%) at the time of FDA clearance, according to a JAMA Network Open report published April 30.

#Device

A victory for early treatment: FDA approves first TAVR valves for asymptomatic severe aortic stenosis

The FDA has approved the balloon-expandable Sapien 3 TAVR platform from Edwards Lifesciences for treating asymptomatic severe aortic stenosis. This is the first time the agency has approved any TAVR technology to be used in asymptomatic patients. Cardiovascular Business / Medpage Today

#Device, #Patient, #Provider

Health and Human Services (HHS)

Health sector answers Trump’s call for deregulation ideas

The Trump administration wants the healthcare industry to recommend rules and regulations to toss. Trade groups representing hospitals, health insurance companies and others are beginning to offer their ideas.

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Health systems in limbo as HHS stays quiet on nondiscrimination rules for AI, algorithms

It’s been a year since the federal government clarified that technology tools used in health care shouldn’t discriminate against patients based on protected traits such as age, sex, race, and disability. A lot has changed in that time, including a new president in the White House. But as the May 1 deadline approaches this week, health systems face significant clinical and political uncertainty over how to comply with the rule.

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CDC Advisory Committee’s Days Are Numbered

With several members receiving termination letters and its webpage archived, public health experts believe the days are numbered for CDC’s Healthcare Infection Control Practices Advisory Committee (HICPAC).

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CDC’s annual HIV report is missing crucial data

The CDC posted an annual HIV report on Tuesday. It was slimmer than usual. The CDC said that a usual estimate of the incidence and prevalence of the epidemic over the last four years was “delayed.” And it did not release an estimate on how widely PrEP, a powerful medicine for preventing HIV, is being used across the country.

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Trump Order Targets Med School, Residency Accreditors Over ‘Unlawful’ DEI Standards

A recent executive order criticizes the two main accrediting bodies for medical schools and residency programs in the United States for engaging in what Trump describes as “unlawful discriminatory practices” related to Diversity, Equity, and Inclusion (DEI) standards.

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Mixing Science and Politics Leads to Trouble, Former NIH Director Says

“When you mix politics and science, you just get politics.” Former NIH director Francis Collins, MD, PhD, made that comment Tuesday at an event here sponsored by The Atlantic as he reflected on the lessons he learned from his early experiences during the COVID pandemic. And although the country’s political polarization became more evident during that time, the seeds were sown even earlier, during the Obama administration, Collins said.

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NIH halts funding for new projects with foreign collaborators, citing national security concerns

The National Institutes of Health announced Thursday it will no longer allow subawards to foreign institutions, as part of a national security-minded overhaul to how the agency manages its $47 billion research funding portfolio. The change is likely to cause immediate disruptions to research projects around the world.

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NIH plans to reduce animal testing in federally funded research

In a significant move, the National Institutes for Health said it would reduce its reliance on animals in federally funded research and instead prioritize investment in human-based alternatives, the second time this month that a key government agency has taken such a step.

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Hill Happenings

Collins and fellow GOP senators speak out in opposition to Trump’s cuts to biomedical research

There was broad bipartisan support to reverse course on the Trump administration’s cuts to federally funded biomedical research. Sen. Susan Collins (Maine), the Republican chair of the Senate Appropriations Committee, kicked off the hearing with a rebuke of the Trump administration for cutting federal biomedical research funding, cancelling grants, and laying off federal health department employees, and said the changes must be reversed.

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Notable Notes

Trump Budget to Take Ax to ‘Radical’ Safety Net Programs

The Trump administration’s upcoming budget proposal for the 2026 fiscal year is expected to include significant cuts to various federal programs. The proposed budget aims to eliminate or significantly reduce funding for programs supporting child care, health research, education, housing assistance, community development, and services for the elderly. The budget proposes around $40 billion in cuts to the Department of Health and Human Services, including significant reductions to the National Institutes of Health and the Centers for Disease Control and Prevention (CDC). Proposed cuts of about $2 billion to agencies like the FBI and DEA could affect their operations and the budget draft calls for over $16 billion in cuts to foreign aid and humanitarian assistance under an “America First” strategy, pausing all foreign assistance while emphasizing domestic priorities.

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Coalition Proposes Alternative to Prior Auth

The End Burnout Group (EBG), a multi-disciplinary group of clinicians and informaticists identified prior authorization as a leading root cause of burnout. They propose evidence-based care optimization (ECO) to minimize unnecessary care while better serving patients, clinicians, and the economy. ECO leverages existing digital tools to automate the certification of clinical appropriateness using national clinical guidelines, and integrates a separate digital insurance query to determine coverage terms. The goal is to separate certifying clinical appropriateness from determining insurance coverage.

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Preventing Veteran Suicide (Rand)

In this report, the authors analyze current and emerging activities to prevent veteran suicide. They introduce the RAND Suicide Prevention Activity Matrix, a framework that organizes current approaches, how they complement each other, how they might change, their evidence for preventing veteran suicide, and why they might (or might not) work.

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Medtech companies try to head off price increases after tariffs

Medtech companies such as Boston Scientific, GE HealthCare and Baxter are taking measures to soften the blow of tariffs.

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Tariffs are hitting surgical robots and pacemakers, but device companies aren’t sweating it, yet

President Trump’s tariffs are adding hundreds of millions of dollars in costs to individual medical device firms and diagnostic companies. The biggest manufacturers are relatively unbothered by it.

#Device

Trump’s pharma tariffs could raise prices by 12.9%, report shows

An industry report commissioned by the Pharmaceutical Research and Manufacturers of America warns about price hikes resulting from President Donald Trump’s proposed 25% tariffs on drugs.

The report, conducted by consultants at Ernst & Young, was not made public. However, journalists from Reuters were able to review a copy. A leaked report from Ernst & Young says President Donald Trump’s proposed 25% tariff on drugs would stifle domestic manufacturing and force the industry to take on an additional $51 billion in annual costs.

#Drug

The 340B Drug Discount Program Needs Fixing, Experts Suggest

The 340B drug discount program would work better if the money followed the patient rather than going directly to hospitals, Anthony DiGiorgio, DO, MHA, said Monday at an event on 340B sponsored by the American Enterprise Institute.

#Drug, #Hospital, #Patient

Pharma’s reputation with patient groups dips again, mostly due to pricing issues

For the second consecutive year, the pharmaceutical industry saw its reputation slip among patient advocacy groups, largely due to ongoing concerns over pricing issues, according to a new survey.

#Drug, #Patient

Survey: What Patients and Providers Are Thinking About Healthcare Access

Experian Health released its annual 2025 State of Patient Access Survey. Patients and providers found common ground on the importance of correct billing estimates but did not see eye to eye in terms of digital scheduling tool use, according to a new survey by Experian Health.

#Patient, #Provider

Society of Thoracic Surgeons shares new risk calculator for complex aortic procedures

The Society of Thoracic Surgeons (STS) has published a new risk calculator focused on ascending aorta and aortic root surgeries. “This risk calculator fills a critical gap for cardiothoracic surgeons treating complex aortic pathology,” STS President Joseph F. Sabik III, MD, “It empowers surgeons to have more transparent, productive conversations with patients and families about surgical risks and benefits, leading to better-informed decision making.”

#Provider, #Patient

Modest Trickle of PCI Into Ambulatory Surgery Centers Despite CMS Payment

Medicare claims records showed a modest increase in the share of percutaneous coronary intervention (PCI) procedures done at freestanding ASCs from 2018 to 2022, rising from 0.01 to 0.87 per 10,000 Medicare beneficiaries. Since CMS started reimbursing for PCI in ASCs in 2020, just 1.8% of outpatient PCIs nationwide took place in them up through 2022, according to Katerina Dangas, BMBCh, research fellow at Beth Israel Deaconess Medical Center in Boston, reporting here at the Society for Cardiovascular Angiography & Interventionsopens in a new tab or window (SCAI) annual meeting.

#Provider, #Patient, #Device

Cardiologists share late-breaking TAVR data on first day of SCAI 2025

The opening day of SCAI 2025 Scientific Sessions, the annual meeting of the Society for Cardiovascular Angiography and Interventions (SCAI), included two late-breaking clinical trials focused on transcatheter aortic valve replacement (TAVR). TAVR continues to gain momentum as a go-to treatment option for patients presenting with severe aortic stenosis. In fact, SCAI estimates that more than 100,500 TAVR procedures were performed in the United States in 2023 alone. These latest studies should help guide treatment decisions made by interventional cardiologists and other members of the heart team going forward. One late-breaking study examined the impact of recommending single antiplatelet therapy (SAPT) over dual antiplatelet therapy (DAPT) after patients undergo femoral TAVR. Another late-breaking study focused on prosthesis-patient mismatch (PPM), one of the more common complications associated with TAVR procedures.

#Provider, #Patient, #Device

Latest EARLY TAVR data suggest it is time to update industry guidelines

Philippe Genereux, MD, principal investigator of EARLY TAVR, presented new data at ACC.25 showing intervening early on crossover patients with asymptomatic severe aortic stenosis led to better outcomes and a reduced stroke rate.

#Provider, #Patient, #Device