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Congressional:
House Passes Expand Chronic Disease Coverage Act
On Tuesday, the House passed the Expand Chronic Disease Coverage Act (H.R. 919) under suspension of the rules. The bill would cover additional preventive care services for chronic diseases before an individual reaches their deductible for those with high-deductible health plans paired with health savings accounts (HSA). The bill would codify IRS guidance from 2019 that expanded the list of preventive care to include 14 chronic disease treatments. Covered care under the guidance includes:
- Inhaled corticosteroids and peak flow meters for asthma.
- Beta-blockers for congestive heart failure.
- Blood pressure monitors for high blood pressure.
- Glucometers, hemoglobin A1c testing, insulin, and retinopathy screening for diabetes.
- Selective serotonin reuptake inhibitors, or SSRIs, for depression.
The bill would also allow the IRS to expand the list of covered chronic disease preventive care. The bill now heads to the Senate. Read the bill here.
Senate HELP Committee Holds Nomination Hearing on Jay Bhattacharya to be NIH Director
On Wednesday, the Senate Health, Education, Labor and Pensions (HELP) Committee held a nomination hearing to consider Jay Bhattacharya to lead the National Institutes of Health (NIH). During the hearing, Bhattacharya told senators he aims to restore trust in public health and science, bring more transparency to research, entertain diverse ideas in science, and focus on chronic diseases. In his opening statement, Chair Bill Cassidy (R-LA) highlighted NIH's significant role in global biomedical research, acknowledged the impact of NIH funding on states, and emphasized the need for reform at NIH, particularly in restoring trust in public health and scientific institutions post-COVID-19. Ranking Member Sanders emphasized the need for an NIH Director who would challenge pharmaceutical industry greed but questioned whether Dr. Bhattacharya would have the authority under the current administration. When questioned about the Trump administration’s recent firing of NIH employees, Bhattacharya repeatedly responded that he was not involved in the administration’s early moves and that he would revisit them, follow the law, and ensure NIH researchers get the money they need. He also stated that it made sense for the NIH to audit how it uses its resources to restore flagging trust in public health. "The broader problem is we have deep distrust of universities and scientific establishments during the pandemic," Bhattacharya said. "Transparency will solve that problem." The HELP Committee will vote on Bhattacharya’s nomination next week, on Thursday, March 13. Read Bhattacharya’s testimony here.
Senate HELP Committee Holds Nomination Hearing on Martin Makary to Lead FDA
On Thursday, the Senate Health, Education, Labor and Pensions (HELP) Committee held a nomination hearing to consider Martin Makary to lead the Food and Drug Administration (FDA). Makary is a surgeon at Johns Hopkins University and has written multiple books about the cost of health care and the factors that affect the quality of care in the United States. He was previously a Fox News contributor who frequently appeared on the channel to discuss topics ranging from the COVID-19 vaccine to the quality of the food supply. During the hearing, Makary pledged to take a data-driven approach to decision-making if confirmed to lead the agency. But he avoided making commitments to Democrats on how the agency would regulate the abortion drug mifepristone, make FDA staffing decisions, or reconvene outside experts on flu vaccine strain selection. Instead, he repeatedly told members he would scrutinize the pill’s safety data and talk to career scientists at the agency. He also noted that he was not involved in agency layoffs or the cancellation of the FDA’s flu vaccine strain selection advisory meeting. The HELP Committee will vote on Makary’s nomination next week, on Thursday, March 13. Read Makary’s testimony here.
Senate Democrats Lay Groundwork to Revive Health Care Package
Senate Democrats are making a new push to pass a health care package that ultimately did not make it into a spending measure at the end of last Congress. Sen. Ron Wyden, ranking member of the Senate Finance Committee, and Sen. Bernie Sanders (I-VT), ranking member of the Senate HELP Committee, introduced a bill Thursday (S.891) that is comprised of provisions taken from the draft bipartisan health package from December. Last year's package included a slate of health program extenders, including an extension of Medicare telehealth coverage, which expires March 31 without congressional action, and increased funding for the Medicare physician fee schedule to mitigate doctor pay cuts, which took effect in January. It also would have extended the Food and Drug Administration’s (FDA) pediatric priority review voucher program through fiscal 2029, reauthorized pandemic preparedness law for another two years, and included policies related to pharmacy benefit managers (PBMs) policies to prevent spread pricing in Medicaid and “delink” a PBM’s compensation from a drug’s list price in Medicare Part D beginning in January 2028.
Sens. Wyden and King Demand Answers on Firing of Medicare and Medicaid Workers
On Thursday, Senate Finance Committee Ranking Member Ron Wyden (D-OR) and Senator Angus King (I-ME) sent a letter to Centers for Medicare & Medicaid Services (CMS) Acting Administrator Stephanie Carlton asking questions regarding reports of widespread firings at CMS. The Senators are seeking information about the number of employees who have been fired, their roles, and how the agency determined which employees should be fired. The Senators are also requesting information on further staffing reductions at the agency. Wyden and King wrote in their letter that “Cuts to this already understaffed agency will undermine the ability of CMS to effectively serve taxpayers and carry out its statutory obligations established by legislation passed by Congress.” Read the press release and letter here.
Notable Bills Introduced:
Sens. Blackburn, Hassan, Colleagues Introduce the Patients Before Middlemen Act
On Thursday, Sens. Marsha Blackburn (R-TN), Maggie Hassan (D-NH), and Mark Warner (D-VA) introduced the Patients Before Middlemen (PBM) Act, which would delink the compensation of pharmacy benefit managers (PBMs) from drug price and utilization. The bill would also require Medicare Part D plans to contract with any willing pharmacy that meets reasonable terms and conditions. Read the press release here and the bill here.
Sens. Marshall and Kaine Introduce Legislation to Protect Patients from High Drug Costs
On Thursday, Sens. Roger Marshall, M.D. (R-KS) and Tim Kaine (D-VA) introduced the Help Ensure Lower Patient (HELP) Copays Act. The legislation would clarify the Affordable Care Act’s (ACA) definition of cost sharing to ensure payments made “by or on behalf of” patients count towards their deductible and/or out-of-pocket maximum, prohibiting “copay accumulator adjustor programs.” It would also clarify that the ACA’s annual out-of-pocket limit applies to all prescription drugs covered in a health plan since all covered drugs would be defined as “essential,” prohibiting “copay maximizer programs.” Read the press release here and the bill here.
Sen. Tillis Leads Legislation to Restore Incentives for Drug Innovation
On Wednesday, Sens. Thom Tillis (R-NC), Ted Budd (R-NC), Marsha Blackburn (R-TN), James Lankford (R-OK), and Steve Daines (R-MT) introduced the Ensuring Pathways to Innovative Cures (EPIC) Act, legislation that would change the Inflation Reduction Act so that small molecule drugs would become eligible for Medicare’s Drug Price Negotiation program after 11 years post-FDA approval, with the negotiated prices going into effect in year 13, instead of 9 and 11 years respectively under current law. Read the press release here and the bill here.
Reps. Matsui, Bilirakis, Thompson, & Sens. Klobuchar, Wicker Introduce Bipartisan Legislation to Increase Cancer Patient Access to Molecular Diagnostic Testing
On Wednesday, Reps. Doris Matsui (D-CA), Gus Bilirakis (R-FL), and Mike Thompson (D-CA), as well as Sens. Amy Klobuchar (D-MN) and Roger Wicker (R-MS), introduced bipartisan, bicameral legislation to increase access to molecular diagnostic testing for rare cancer patients. The Finn Sawyer Access to Cancer Testing Act would ensure patients on Medicare, Medicaid, and the Children's Health Insurance Program (CHIP) can receive testing at the time of first diagnosis, rather than only for recurrent or metastatic cancers. Read the press release here.
Sens. Cassidy, Peters Introduce Bill to Protect Americans' DNA, National Security
On Wednesday, Sens. Bill Cassidy, M.D. (R-LA) and Gary Peters (D-MI) introduced the Genomic Data Protection Act to give Americans using at-home DNA tests the choice to delete their genomic data and destroy their biological samples. Around 21% of Americans have taken a mail-in DNA test from a direct-to-consumer genomic testing company. The sponsors say the absence of privacy protections allows for the potential selling of Americans’ data, posing a risk to consumers and the country’s national security if a bad actor obtains the information. Read the press release here and the bill here.
Sens. Collins, Baldwin Introduce Bipartisan Legislation to Support the Health and Wellbeing of Family Caregivers
On Tuesday, Sens. Susan Collins (R-ME) and Tammy Baldwin (D-WI) introduced bipartisan legislation to support the health and well-being of family caregivers. The Lifespan Respite Care Reauthorization Act of 2025 would reauthorize the Lifespan Respite Care Program through fiscal year 2030 and clarify that youth caregivers (those under 18 who are providing care or helping to provide care to family members) are eligible for the program. Read the press release here and the bill here.
Rep. Don Davis Introduces Bipartisan Legislation to Preserve Access to Lifesaving Drugs
On Tuesday, Rep. Don Davis (D-NC) introduced the bipartisan Maintaining Investments in New Innovation (MINI) Act, legislation to improve access to medical therapies developed with genetically targeted technology (GTT). Drugs made with GTT are often designed to treat life-threatening rare diseases, and the MINI Act would make changes to when these medications become eligible for negotiation under Medicare’s Drug Price Negotiation program. Reps. Joyce (R-PA), Gottheimer (D-NJ), Tenney (R-NY), Morelle (D-NY), Hudson (R-NC), Yakym (R-IN), Peters (D-CA), Moore (R-UT), Crenshaw (R-TX), Miller-Meeks (R-IA), Van Duyne (R-TX), Allen, (R-GA), & Bean (R-FL) cosponsored the bill. Read the press release here and the bill here.
Reps. Kelly, Thompson, & Smith Introduce Legislation to Expand Americans' Telehealth Options
On Monday, Reps. Mike Kelly (R-PA), Mike Thompson (D-CA), and Adrian Smith (R-NE), members of the Ways & Means Subcommittee on Health, introduced bipartisan legislation that would permanently expand the list of practitioners eligible who provide telehealth services to include qualified physical therapists, occupational therapists, speech language pathologists, and audiologists. Read the press release here and the bill here.
Reps. Miller, Sewell Reintroduce the Assistance for Rural Community Hospitals Act
On Monday, Reps. Carol Miller (R-WV) and Terri Sewell (D-AL) reintroduced the Assistance for Rural Community Hospitals (ARCH) Act. The bill would extend the Medicare-dependent hospital program and Medicare low-volume hospital payments for five years each and include a GAO report to obtain clear information on the different Medicare rural hospital designations. Read the press release here and the bill here.
Sens. Cortez Masto, Daines Introduce Bipartisan Bill to Protect Americans' Access to Telehealth Services
Late last week, on Friday, Sens. Catherine Cortez Masto (D-NV) and Steve Daines (R-MT) introduced bipartisan legislation to make expanded access to telehealth services permanent. The Telehealth Expansion Act would permanently allow full coverage of telehealth services under high-deductible health plans (HDHPs) paired with health savings accounts (HSA) without requiring a deductible. Read the press release here and the bill here.
Rep. Miller, Colleagues Introduce Bipartisan Hospice Recertification Flexibility Act
Late last week, on Friday, Reps. Carol Miller (R-WV), Jared Golden (D-ME), Beth Van Duyne (R-TX), Don Davis (D-NC), Aaron Bean (R-FL), and Joe Morelle (D-NY), introduced the bipartisan the Hospice Recertification Flexibility Act, which allows hospice providers to use telehealth to conduct the face-to-face visit required for hospice recertification after 180 days in hospice care. This provision keeps in line with existing hospice telehealth rules and makes sure that patients can remain in the comfort of their home at the close of their life. Read the press release here and the bill here.
Rep. Gottheimer Reintroduces Bipartisan Legislation to Restore Orphan Disease Research Tax Credit
Late last week, on Friday, Rep. Josh Gottheimer (D-NJ) reintroduced bipartisan legislation, Cameron’s Law, to fully restore the Orphan Drug Tax Credit. The legislation is co-led by Congressmen Don Bacon (R-NE), Jimmy Panetta (D-CA), Tom Suozzi (D-NY), Max Miller (R-OH), and Brian Fitzpatrick (R-PA). Read the press release here and the bill here.
Executive Branch:
Trump Addresses Childhood Cancer in First Address of Second Term to Congress
On Tuesday, President Donald Trump held his first Joint Address of his second term to Congress. During the address, Trump acknowledged Health and Human Services (HHS) Secretary Robert F. Kennedy Jr.’s “Make America Healthy Again” mission. Trump noted the Make America Health Again Commission, which was established by an executive order, and stated, “Since 1975, rates of child cancer have increased by more than 40 percent. Reversing this trend is one of our top priorities for our new Make America Healthy Again Commission.” “Our goal is to get toxins out of our environment, poisons out of the food supply and keep our children healthy and strong,” he added. Trump also pointed to a CDC statistic that 1 in 36 children have been diagnosed with autism, stating, “There’s something wrong.” “We’re going to find out what it is, and there’s nobody better than Bobby to figure out what is going on.”
CMS Releases Rescission of Guidance on Health-Related Social Needs
On Wednesday, the Centers for Medicare and Medicaid Services (CMS) sent a memo announcing the rescission of guidance on health-related social needs. Specifically, CMS is rescinding Coverage of Services and Supports to Address Health-Related Social Needs in Medicaid and the Children’s Health Insurance Program, released on November 16, 2023, and Coverage of Services and Supports to Address Health-Related Social Needs in Medicaid and the Children’s Health Insurance Program, released on December 10, 2024. CMS will consider states’ applications to cover these services and supports on a case-by-case basis to determine whether they satisfy federal requirements for approval under the applicable provisions of the Social Security Act and implementing federal regulations without reference to the November 2023 and December 2024 CIBs or the HRSN Framework. Read the memo here.
In response to the memo, Senator Ron Wyden (D-OR), Ranking Member of the Senate Finance Committee, criticized the decision, stating that the action “marks the first step in the Republican plan to dismantle Medicaid, brick-by-brick.” "Secretary Kennedy appeared to understand this during his confirmation hearings, but once again he has turned his back on Americans in service of the ideological crusade against Medicaid." Read Wyden’s statement here.
HHS Announces it Will No Longer Require Public Comment Periods for Certain Rulemaking Efforts
On Friday, the Health and Human Services Department announced that it plans to end the department's requirement of public comment periods for certain rulemaking to align it with the Administrative Procedures Act (APA). Under the APA, agencies typically are required to give notice and allow a period for public comment when they go through the rulemaking process, but the law allows exemptions for certain rulemaking related to "agency management or personnel or to public property, loans, grants, benefits, or contracts." In 1971, the department adopted a regulation known as the Richardson Waiver, under which the department was still required to solicit public comments for rules falling under those categories. In a policy statement, HHS announced it was rescinding the Richardson Waiver and would instead follow the exemptions in the Administrative Procedure Act. The notice also stated the agency intends to abide by an APA provision that allows the department to forgo the public comment period for "good cause" when it finds that the public comment period would be "impracticable, unnecessary, or contrary to the public interest." Read the policy statement here.
Legal & Other:
NIH Cuts to Indirect Research Funds Blocked by Judge in Preliminary Injunction
On Wednesday, Judge Angel Kelley of the US District Court for the District of Massachusetts issued a nationwide block against the Trump administration’s announcement that the National Institutes of Health (NIH) will limit its coverage of indirect costs for grants to 15 percent. The order granted states and academic groups their motion for a nationwide preliminary injunction that enjoins the NIH from taking any steps to implement the 15 percent cap on indirect funds, which is used by universities and institutions to cover the expenses of facilities, utilities, laboratory equipment, and project support staff. Judge Kelley wrote that “The imminent risk of halting life-saving clinical trials, disrupting the development of innovative medical research and treatment, and shuttering of research facilities, without regard for current patient care, warranted the issuance of a nationwide temporary restraining order to maintain the status quo.” The reduced rate was challenged on February 10 by 22 states and other academic membership organizations who argued the cap violated the Administrative Procedure Act and failed to consider the effects it would have on research. Read the opinion here.
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