Posted on

DNC Approves 2024 Party Platform During Chicago Convention

DNC Approves 2024 Party Platform During Chicago Convention-The Democratic National Committee (DNC) finalized its platform during the Democratic convention in Chicago last week. The 2024 platform reiterates the party’s commitment to protecting Medicare, Medicaid, and the Affordable Care Act (ACA). Under the platform, Democrats would permanently extend enhanced ACA premium subsidies; create dental, vision, and hearing benefits under the Medicare program; and ban surprise billing for ground ambulance services. Democrats would add “at least” 50 drugs annually to the Medicare drug price negotiation program and would create a model to limit Medicare cost sharing for some generic drugs to $2. The DNC also promises to increase transparency around the pharmacy benefit manager industry. The platform supports expansion of the Medicaid program, including through increasing postpartum coverage to a full year, but would require Medicaid managed care organizations to return excess funding to states. The platform promises to “keep using antitrust laws to stop hospital, insurance, and Big Pharma mergers that undermine competition and increase health care prices for consumers.” The DNC proposes to exclude all medical debt from credit reporting and calls for strengthening the nation’s mental and behavioral health care system. Democrats would also repeal the Hyde amendment and codify access to abortion and in vitro fertilization services. While Kamala Harris did not spend much time discussing health care issues during her speech accepting the Democratic presidential nomination, she did pledge to protect Medicare and the ACA, and to address rising health care costs. Harris also warned about the potential impact of a second Trump presidential term on reproductive rights and access to birth control and abortion.

 

Bipartisan Lawmakers Write FDA on China-Linked Clinical Trials-A bipartisan group of lawmakers are asking the Food and Drug Administration (FDA) for details about U.S. pharmaceutical companies conducting clinical trials with medical centers affiliated with the Chinese military. The letter outlines the national security risks and ethical concerns associated with trials that have taken place in Xinjiang as well as hospitals affiliated with the People’s Liberation Army (PLA). The lawmakers cite data indicating that over the last ten years, major U.S. biopharmaceutical companies have conducted hundreds of clinical trials in China that included at least one entity with PLA in the name as a research trial partner. “The United States needs the FDA to take on a greater role in protecting U.S. national security interests. With this data, it is clear that the FDA should play a greater role in analyzing U.S. biopharma entities clinical trial operations in the People’s Republic of China,” the lawmakers argue. The letter was led by Chairman and Ranking Member of the House Select Committee on the Chinese Communist Party John Mollenaar (R-Mich.) and Raja Krishnamoorthi (D-Ill.), and signed by Energy and Commerce Health Subcommittee Ranking Member Anna Eshoo (D-Calif.) and Rep. Neal Dunn (R-Fla.).

 

CBO Updates ACA Subsidy Cost Estimate-The Congressional Budget Office (CBO) estimates that spending on ACA premium tax credits have doubled since it was first calculated in 2020 because of high enrollment. CBO originally estimated a cost of $600 billion between 2021 and 2040; the agency’s updated projection stands at $1.3 trillion between 2025 and 2034. According to CBO, the change is primarily a result of legislation in 2021 and 2022 expanding the premium tax credit through 2025. The update comes in response to a question for the record from Senate Budget Committee Ranking Member Chuck Grassley (R-Iowa) about CBO’s report An Update to the Budget and Economic Outlook: 2024 to 2034.

 

 

GAO Examines FDA’s Medical Device Postmarket Surveillance System-The Government Accountability Office (GAO) has released a new report reviewing the FDA’s work to establish an active postmarket surveillance system for medical devices. GAO’s review details the two key challenges faced by the agency is establishing this system-the limited use of unique device identifiers in electronic health records and billing claims, and funding considerations to support active surveillance. A 2018 study of FDA data found that more than 1.7 million injuries and 83,000 deaths over a ten-year period were potentially linked to medical devices.

 

Second Lawsuit Filed Against FDA LDT Rule-The Association for Molecular Pathology (AMP) filed a lawsuit on Monday against the FDA’s laboratory developed test (LDT) final rule. AMP’s suit cites the Loper Bright Enterprises v. Raimondo Supreme Court ruling, which overturned the Chevron doctrine, in arguing against the LDT final rule. The American Clinical Laboratory Association (ACLA) filed a lawsuit against the final rule in May, before Chevron was overturned. Among other complaints, AMP and ACLA both assert that FDA exceeded their statutory authority in promulgating the LDT final rule and have asked the courts to prohibit FDA from regulating LDTs as medical devices.

 

Judge Blocks FTC’s Ban on Noncompete Agreements-Last week, a federal judge blocked the Federal Trade Commission’s (FTC) nationwide ban on employee noncompete agreements. The judge from the U.S. District Court for the Northern District of Texas argued that the FTC lacked legal authority to prohibit restrictive employment contracts and that the ban was “the product of an unconstitutional exercise of power.” The decision cited the Supreme Court’s Loper Bright Enters. v. Raimondo decision-which overturned the Chevron deference-multiple times. According to an agency spokesperson, the FTC is “seriously” considering an appeal. The FTC rule had been set to take effect on September 4.

 

 

Fourteen Term Democrat Pascrell Dies at 87-Rep. Bill Pascrell (D-N.J.) passed away last Wednesday following a July hospitalization for a respiratory infection. Pascrell, 87, was one of the oldest members of the House of Representatives. He was first elected to Congress in 1996 and served on the Ways and Means Committee. Party officials from New Jersey’s 9th congressional district will select a new candidate for the November election; the deadline to replace Pascrell on the ballot is August 29. There are now 220 Republicans, 211 Democrats, and four vacancies in the House.

 

Congressional Retirements and Resignations-A running list of members of Congress who are retiring or seeking other office can be found below.

 

SENATE
Stabenow (D), MI Braun (R), IN
Cardin (D), MD Romney (R), UT
Carper (D), DE
Butler (D), CA
Manchin (D), WV
Sinema (I), AZ
Menendez (D), NJ (effective Aug. 20, 2024)

 
HOUSE OF REPRESENTATIVES
Porter (D), CA Mooney (R), WV
Lee (D), CA Banks (R), IN
Gallego (D), AZ Bishop (R), NC
Schiff (D), CA Lesko (R), AZ
Slotkin (D), MI Granger (R), TX
Allred (D), TX Burgess, MD (R), TX
Trone (D), MD Wenstrup, DPM (R), OH
Blunt Rochester (D), DE McHenry (R), NC
Napolitano (D), CA Ferguson, IV, DMD, PC (R), GA
Wexton (D), VA Curtis (R), UT
Kim, Andy (D), NJ Luetkemeyer (R), MO
Jackson, Jeff (D), NC Lamborn (R), CO
Sarbanes (D), MD Bucshon, MD (R), IN
Blumenauer (D), OR Pence (R), IN
Kilmer (D), WA Duncan (R), SC
Spanberger (D), VA Armstrong (R), ND
Kildee (D), MI McMorris Rodgers (R), WA
Phillips (D), MN Gallagher (R), WI (effective April 19, 2024)
Cardenas (D), CA Rosendale (R), MT
Eshoo (D), CA Carl (R), AL
Manning (D), NC LaTurner (R), KS
Nickel (D), NC Posey (R), FL
Sablan (D), MP González-Colón (R), PR
Ruppersberger (D), MD Graves (R), LA
Kuster (D), NH Good (R), VA
Bowman (D), NY
Bush (D), MO
Payne (D), NJ (died April 24, 2024)
Jackson Lee (D), TX (died July 19, 2024)
Pascrell (D), NJ (died Aug. 21, 2024)

 

Upcoming Congressional Hearings and Markups

Senate HELP Committee hearing “Why Is Novo Nordisk Charging Americans with Diabetes and Obesity Outrageously High Prices for Ozempic and Wegovy?” 10:00 a.m.; September 24

 

Recently Introduced Health Legislation

H.R.9365-To amend title XVIII of the Social Security Act to provide for coverage under the Medicare program of pharmacist services; Sponsor: Davis, Donald G. [Rep.-D-NC-1]; Committees: House-Energy and Commerce; Ways and Means

 

H.R.9367-To amend the Federal Food, Drug, and Cosmetic Act to require a recall of electronic nicotine delivery systems that have not been subject to premarket review, and for other purposes; Sponsor: DeSaulnier, Mark [Rep.-D-CA-10]; Committees: House-Energy and Commerce

 

H.R.9382-To amend the Federal Food, Drug, and Cosmetic Act to add alpha-gal to the definition of “major food allergen;” Sponsor: Van Drew, Jefferson [Rep.-R-NJ-2]; Committees: House-Energy and Commerce

 

H.R.9383-To amend the Older Americans Act of 1965 to include screening for loneliness and coordination of supportive services and health care to address the negative health effects of loneliness, to require a report on loneliness, and for other purposes; Sponsor: Banks, Jim [Rep.-R-IN-3]; Committees: House-Education and the Workforce

 

H.R.9384-To amend title XVIII of the Social Security Act to require the Secretary of Health and Human Services to provide an explanation of benefits not later than 30 days after an item or service is furnished under the Medicare program; Sponsor: Bean, Aaron [Rep.-R-FL-4]; Committees: House-Ways and Means; Energy and Commerce

Posted on

Hoyer Recovers from Mild Stroke

Hoyer Recovers from Mild Stroke-Rep. Steny Hoyer (D-Md.), 85, experienced a stroke on August 11, the congressman’s office announced last week. He is not experiencing any lingering symptoms following treatment for the mild ischemic stroke. Hoyer, the former House majority leader, is expected to resume his normal schedule this week.

 

 

George Helmy Tapped to Fill Menendez’s Senate Seat-New Jersey Governor Phil Murphy (D) has appointed his former chief of staff George Helmy to fill the seat of Sen. Bob Menendez (D) until early next year. Menendez was convicted on federal corruption charges last month and will resign from the Senate effective August 20. Helmy is an executive vice president at the New Jersey health system RWJ Barnabas Health and is on the Board of Commissioners of the Port Authority of New York and New Jersey. Rep. Andy Kim (D) is heavily favored to win the full six-year term in the November election, in which Menendez has filed to run as an independent. It remains unclear whether Menendez will remain on the ballot.

 

White House Announces First 10 Negotiated Medicare Drug Prices-On Thursday, the Biden administration announced the maximum fair prices of the first 10 drugs selected for the Medicare price negotiation process established by the Inflation Reduction Act in 2022. The new prices will go into effect for people with Medicare Part D prescription drug coverage starting January 1, 2026.

 

The White House estimates that if the new prices had been in effect last year, Medicare would have saved an estimated $6 billion, or 22%, across the 10 selected drugs. Approximately nine million people with Medicare use at least one of the 10 selected drugs, and these individuals are expected to see aggregated estimated savings of $1.5 billion in out-of-pocket costs in 2026. Throughout the negotiation process, the Centers for Medicare and Medicaid Services (CMS) raised its offers for each drug following discussions with the pharmaceutical manufacturer, while many of the manufacturers lowered their counteroffers. CMS will select up to 15 more Part D drugs for negotiation for 2027 by February 1, 2025. The agency will select up to 15 more drugs covered by Part B or Part D for 2028, and up to 20 more Part B or Part D drugs for each year after that.

 

 

President Announces New Cancer Moonshot Research Awards-President Joe Biden announced $150 million in new Advanced Research Projects Agency for Health awards as a part of his Cancer Moonshot initiative last week. The new grants will support eight teams of researchers at Tulane University; Dartmouth College; Johns Hopkins University; Rice University; the University of California, San Francisco; the University of Illinois Urbana-Champaign; the University of Washington; and Cision Vision in Mountain View, California working to improve tumor removal technologies for people with cancer. The President has stated that the Cancer Moonshot will be a priority of his final months in office. Biden’s Cancer Moonshot, originally authorized as part of the 21st Century Cures Act while Biden was Vice President, aims to ultimately reduce the nation’s cancer death rate by 50% over the next 25 years.

 

 

Congressional Retirements and Resignations-A running list of members of Congress who are retiring or seeking other office can be found below.

 

SENATE
Stabenow (D), MI Braun (R), IN
Cardin (D), MD Romney (R), UT
Carper (D), DE
Butler (D), CA
Manchin (D), WV
Sinema (I), AZ
Menendez (D), NJ (effective Aug. 20, 2024)
HOUSE OF REPRESENTATIVES
Porter (D), CA Mooney (R), WV
Lee (D), CA Banks (R), IN
Gallego (D), AZ Bishop (R), NC
Schiff (D), CA Lesko (R), AZ
Slotkin (D), MI Granger (R), TX
Allred (D), TX Burgess, MD (R), TX
Trone (D), MD Wenstrup, DPM (R), OH
Blunt Rochester (D), DE McHenry (R), NC
Napolitano (D), CA Ferguson, IV, DMD, PC (R), GA
Wexton (D), VA Curtis (R), UT
Kim, Andy (D), NJ Luetkemeyer (R), MO
Jackson, Jeff (D), NC Lamborn (R), CO
Sarbanes (D), MD Bucshon, MD (R), IN
Blumenauer (D), OR Pence (R), IN
Kilmer (D), WA Duncan (R), SC
Spanberger (D), VA Armstrong (R), ND
Kildee (D), MI McMorris Rodgers (R), WA
Phillips (D), MN Gallagher (R), WI (effective April 19, 2024)
Cardenas (D), CA LaTurner (R), KS
Eshoo (D), CA Graves (R), LA
Manning (D), NC
Nickel (D), NC
Ruppersberger (D), MD
Sablan (D), MP
Kuster (D), NH
Bowman (D), NY

 

 

Upcoming Congressional Hearings and Markups

Senate HELP Committee hearing “Why Is Novo Nordisk Charging Americans with Diabetes and Obesity Outrageously High Prices for Ozempic and Wegovy?” 10:00 a.m.; September 24

 

 

Recently Introduced Health Legislation

H.R.9328-To amend title 38, United States Code, to establish additional presumptions of service connection for certain diseases that occur in veterans who suffered toxic exposure while serving at Karshi Khanabad Air Base, Uzbekistan; Sponsor: Green, Mark E. [Rep.-R-TN-7]; Committees: House-Veterans’ Affairs

 

H.R.9333-To amend the Internal Revenue Code of 1986 to provide an income tax credit for the costs of certain fertility treatments; Sponsor: Kean, Thomas H. [Rep.-R-NJ-7]; Committees: House-Ways and Means

 

H.R.9335-To direct the Secretary of Defense to carry out a pilot program to provide services from midwives to covered beneficiaries under the TRICARE program; Sponsor: Kilmer, Derek [Rep.-D-WA-6]; Committees: House-Armed Services

 

H.R.9350-To direct the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, to revise part 71 of title 42, Code of Federal Regulations, to allow for the import of certain dogs without rabies vaccination documentation or an import form, and for other purposes; Sponsor: Kennedy, Timothy M. [Rep.-D-NY-26]; Committees: House-Energy and Commerce

 

H.R.9351-To amend title XIX of the Social Security Act to modify certain limitations on disproportionate share hospital payment adjustments under the Medicaid program; Sponsor: LaLota, Nick [Rep.-R-NY-1]; Committees: House-Energy and Commerce

 

H.R.9352-To amend title XXVII of the Public Health Service Act and title 5, United States Code, to require group health plans, health insurance issuers offering group or individual health insurance coverage, and Federal Employees Health Benefits Program health benefits plans to meet certain requirements with respect to medical child support orders, and for other purposes; Sponsor: Norton, Eleanor Holmes [Del.-D-DC-At Large]; Committees: House-Energy and Commerce; Ways and Means; Oversight and Accountability

Posted on

Harris Selects Tim Walz as Running Mate

Harris Selects Tim Walz as Running Mate-Kamala Harris announced her selection of Minnesota Gov. Tim Walz as her running mate on Tuesday. Walz is a second-term governor who served in the House of Representatives from 2007 to 2019. As a member of the House, Walz developed a reputation as a moderate dealmaker who focused on his work as a member of the Veterans’ Affairs and Agriculture committees. During his time on Capitol Hill, Walz supported Medicare drug price negotiation efforts, expansion of cannabis medical research, and further studies of the health effects of Agent Orange on veterans. As Minnesota governor, Walz instated shutdowns, social distancing policies, mask mandates, and vaccine requirements for government employees in response to the coronavirus pandemic. His administration has implemented drug price transparency requirements, created a Prescription Drug Affordability Board, and capped out of pocket insulin costs. Walz and the Minnesota legislature also created a state-based public health insurance option last year. Walz is a vocal defender of both abortion access and gender-affirming care-codifying abortion rights in the state constitution and shielding patients and providers from other states’ abortion and gender-affirming care penalties. Walz has frequently shared his family’s struggle with infertility and their use of in vitro fertilization when discussing reproductive health care. He also has enacted climate policy at the state level.

 

 

Bicameral Republicans Raise Questions About Part D Stabilization Demonstration-Republican leaders of the Senate Finance Committee and the House Ways and Means and Energy and Commerce committees are urging the Government Accountability Office to conduct a review of the Medicare Part D Premium Stabilization Demonstration recently announced by the Centers for Medicare and Medicaid Services (CMS). The letter questions the legality of the demonstration and expresses concerns about its potential impact on health care affordability for seniors. The lawmakers go on to argue that CMS is “waiving statutory directives under the guise of a ‘demonstration project,’ with no meaningful research aims, budgetary assessments, or empirical rigor.”

 

 

CBO Responds to Budget Committee Questions for the Record-The Congressional Budget Office (CBO) has asserted that vertical integration of pharmacy benefit managers (PBMs) and health insurers does not necessarily result in lower premiums for plan enrollees. While consolidation may lead to lower drug prices in such health plans, these reductions in spending may not necessarily be passed on to enrollees in the form of lower premiums, and may result in drug costs and premiums increasing for other insurers using the PBM. This information comes in response to a question for the record from House Budget Committee Chairman Jodey Arrington (R-Texas) following a hearing on hospital and physician consolidation and its impact on the federal budget. Arrington also posed a question regarding the potential impact of site-neutral payment reform on commercial market prices. In response, CBO asserts its belief that expanding Medicare’s use of site-neutral payments would not increase the prices paid by commercial insurers-an argument frequently made by skeptics of such policies. “From the perspective of economic theory, it is unclear why hospitals would negotiate higher prices with private payers only after they experienced payment reductions from public payers,” the agency writes.

 

Senate Finance Probes Possible Ethics Violation by New UNOS CTO-Senate Finance Committee Chairman Ron Wyden (D-Ore.) and Finance committee member Chuck Grassley (R-Iowa) have sent letters to the United Network for Organ Sharing (UNOS), the Health Resources and Services Administration, and the Office of Management and Budget regarding UNOS’ hiring of Ankit Mathur as UNOS chief technology officer in March. Mathur previously worked as chief delivery officer at US Digital Service. He is thus restricted by federal post-employment regulations in what activities he can perform in his new position at UNOS, and the lawmakers are probing what, if any, ethics violations may have occurred with Mathur’s hiring. “We are concerned that UNOS has not taken this matter as seriously as it should,” the letters state. Wyden and Grassley request details from the administration about the time periods for ethics restrictions that Mathur was under after he left the government to join UNOS, and about actions that were taken in preparation for and in response to his hiring.

 

Senators Push for Medicare Coverage of Wheelchair Standing Systems-A bipartisan group of senators have written to the Biden administration urging the Centers for Medicare and Medicaid Services (CMS) to cover standing systems embedded in power wheelchairs under the Medicare program. The agency proposed for the first time last year to provide Medicare coverage of seated elevation systems in power wheelchairs. The lawmakers thank CMS for its decision, but express concerns that the agency has not yet initiated a National Coverage Analysis for standing systems in these wheelchairs, arguing that the absence of Medicare coverage for these systems leaves many beneficiaries “without access to critical technology that can significantly improve their health outcomes and quality of life.” The letter was signed by Sens. Tammy Duckworth (D-Ill.), Marsha Blackburn (R-Tenn.), and Bob Casey (D-Pa.).

 

OSU Awarded $15 Million NIH Grant to Study Long COVID Cure-The Ohio State University (OSU) has been awarded the largest ever infectious diseases grant from the National Institutes of Health (NIH) to study a cure for long COVID. The five-year study will focus on a specific enzyme produced by certain COVID patients in high levels. The $15 million grant was awarded to build on a 2022 study by OSU researchers suggesting that blocking the single molecule could protect against severe illness from infection with the SARS-CoV-2 virus.

 

 

 

Congressional Retirements and Resignations-Rep. Cori Bush (D-Mo.) lost the Democratic primary race for Missouri’s 1st congressional district to St. Louis County Prosecuting Attorney Wesley Bell. Bush is the second member of the progressive “Squad” to lose a primary this election cycle. She was first elected to the House of Representatives in 2020 and currently serves as a member of the House Committee on Oversight and Accountability and the Committee on the Judiciary.

 

A running list of members of Congress who are retiring or seeking other office can be found below.

SENATE
Stabenow (D), MI Braun (R), IN
Cardin (D), MD Romney (R), UT
Carper (D), DE
Butler (D), CA
Manchin (D), WV
Sinema (I), AZ
Menendez (D), NJ (effective Aug. 20, 2024)
HOUSE OF REPRESENTATIVES
Porter (D), CA Mooney (R), WV
Lee (D), CA Banks (R), IN
Gallego (D), AZ Bishop (R), NC
Schiff (D), CA Lesko (R), AZ
Slotkin (D), MI Granger (R), TX
Allred (D), TX Burgess, MD (R), TX
Trone (D), MD Wenstrup, DPM (R), OH
Blunt Rochester (D), DE McHenry (R), NC
Napolitano (D), CA Johnson (R), OH (effective Jan. 21, 2024)
Wexton (D), VA Ferguson, IV, DMD, PC (R), GA
Kim, Andy (D), NJ Curtis (R), UT
Jackson, Jeff (D), NC Luetkemeyer (R), MO
Sarbanes (D), MD Lamborn (R), CO
Blumenauer (D), OR Bucshon, MD (R), IN
Kilmer (D), WA Pence (R), IN
Spanberger (D), VA Duncan (R), SC
Kildee (D), MI Armstrong (R), ND
Phillips (D), MN McMorris Rodgers (R), WA
Cardenas (D), CA Gallagher (R), WI (effective April 19, 2024)
Eshoo (D), CA LaTurner (R), KS
Manning (D), NC Graves (R), LA
Nickel (D), NC
Ruppersberger (D), MD
Sablan (D), MP
Kuster (D), NH
Bowman (D), NY

 

 

 

Upcoming Congressional Hearings and Markups

Senate HELP Committee hearing “Why Is Novo Nordisk Charging Americans with Diabetes and Obesity Outrageously High Prices for Ozempic and Wegovy?” 10:00 a.m.; September 24

 

 

Recently Introduced Health Legislation

H.Res.1400-Supporting the goals and ideals of Fentanyl Prevention and Awareness Day on August 21, 2024; Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Cosponsors: (2) Committees: House-Energy and Commerce

 

H.Res.1404-Expressing support for keeping guns out of classrooms; Sponsor: Hayes, Jahana [Rep.-D-CT-5]; Committees: House-Education and the Workforce; Judiciary

 

H.R.9237-To improve end-of-life care; Sponsor: Barragan, Nanette Diaz [Rep.-D-CA-44]; Committees: House-Energy and Commerce; Ways and Means

 

H.R.9243-To require the Administrator of the Federal Aviation Administration to publish the list of medications that the Administrator has compiled for purposes of the medical certification of airmen, and for other purposes; Sponsor: Casten, Sean [Rep.-D-IL-6]; Committees: House-Transportation and Infrastructure

 

H.R.9249-To amend title 5, United States Code, to require the publication of scientific data, incident data, or other pertinent data relied on by an agency to justify a rule; Sponsor: Edwards, Chuck [Rep.-R-NC-11]; Committees: House-Judiciary

 

H.R.9250-To create an Active Shooter Alert Communications Network, and for other purposes; Sponsor: Escobar, Veronica [Rep.-D-TX-16]; Committees: House-Judiciary

 

H.R.9253-To provide for a coordinated national research program to examine the nature, causes, consequences, and prevention of violence and unintended injury and death relating to gun ownership, use, and trafficking, and for other purposes; Sponsor: Foushee, Valerie P. [Rep.-D-NC-4]; Committees: House-Judiciary; Science, Space, and Technology; Energy and Commerce

 

H.R.9258-To amend the Federal Food, Drug, and Cosmetic Act to require pill press molds to bear a unique serial number, to amend the Controlled Substances Act to prohibit the knowing possession of a pill press mold with intent to manufacture certain counterfeit substances, and for other purposes; Sponsor: Harder, Josh [Rep.-D-CA-9]; Committees: House-Energy and Commerce; Judiciary

 

H.R.9260-To prohibit State excise taxes on firearms and ammunition manufacturers and dealers; Sponsor: Issa, Darrell [Rep.-R-CA-48]; Committees: House-Judiciary

 

H.R.9269-To amend the Internal Revenue Code of 1986 to provide an income tax credit for fertility treatments; Sponsor: Lawler, Michael [Rep.-R-NY-17]; Committees: House-Ways and Means

 

H.R.9271-To amend title XVIII of the Social Security Act to make permanent certain telehealth flexibilities under the Medicare program for telehealth services furnished by Indian health programs; Sponsor: Leger Fernandez, Teresa [Rep.-D-NM-3]; Committees: House-Energy and Commerce; Ways and Means

 

H.R.9272-To amend title XVIII of the Social Security Act to establish new payment rules for certain catastrophic specialty hospitals under the Medicare program; Sponsor: Loudermilk, Barry [Rep.-R-GA-11]; Committees: House-Ways and Means

 

H.R.9275-To amend the Internal Revenue Code of 1986 to provide a refundable tax credit for non-directed living kidney donations; Sponsor: Malliotakis, Nicole [Rep.-R-NY-11]; Committees: House-Ways and Means; Energy and Commerce

 

H.R.9276-To expand medical, employment, and other benefits for individuals serving as family caregivers for certain veterans, and for other purposes; Sponsor: Morelle, Joseph D. [Rep.-D-NY-25]; Committees: House-Veterans’ Affairs; Ways and Means

 

H.R.9298-To amend the Internal Revenue Code of 1986 to treat qualified water competency and water safety lesson expenses as medical expenses; Sponsor: Steube, W. Gregory [Rep.-R-FL-17]; Committees: House-Ways and Means

 

H.R.9300-To amend title II of the Social Security Act and the Internal Revenue Code of 1986 to make improvements in the old-age, survivors, and disability insurance program; Sponsor: Tokuda, Jill N. [Rep.-D-HI-2]; Committees: House-Ways and Means; Energy and Commerce; Education and the Workforce

 

H.J.Res.200-Disapproving the rule submitted by the Department of Health and Human Services relating to “Control of Communicable Diseases; Foreign Quarantine: Importation of Dogs and Cats”; Sponsor: Golden, Jared F. [Rep.-D-ME-2]; Committees: House-Energy and Commerce

 

H.R.9304-To require the Director of the National Cancer Institute to conduct a review of the current state of stomach cancer incidence, prevention, screening, awareness, and future public health importance, and for other purposes; Sponsor: Caraveo, Yadira [Rep.-D-CO-8]; Committees: House-Energy and Commerce

 

H.R.9305-To direct the Secretary of Health and Human Services to make grants to local governments for the training of local law enforcement officers on public health threats arising from violations of building codes, and for other purposes; Sponsor: Costa, Jim [Rep.-D-CA-21]; Committees: House-Transportation and Infrastructure

 

H.R.9310-To amend title 18, United States Code, to provide Tribal courts and law enforcement with more tools to combat the opioid epidemic; Sponsor: Larsen, Rick [Rep.-D-WA-2]; Committees: House-Judiciary; Natural Resources

 

H.R.9314-To amend the Public Health Service Act to provide for a national program to conduct and support activities toward the goal of significantly reducing the number of cases of overweight and obesity among individuals in the United States; Sponsor: Norton, Eleanor Holmes [Del.-D-DC-At Large]; Committees: House-Energy and Commerce

 

H.R.9321-To direct the Secretary of Health and Human Services to conduct a demonstration program to test providing preferential treatment under the Medicare, Medicaid, and CHIP programs for certain drugs and biologicals manufactured in the United States; Sponsor: Slotkin, Elissa [Rep.-D-MI-7]; Committees: House-Energy and Commerce; Ways and Means

 

H.R.9324-To amend title 38, United States Code, to authorize certain heath care professionals employed by the Department of Veterans Affairs to deliver, distribute, or dispense to veterans certain controlled medications via telemedicine under certain conditions, and for other purposes; Sponsor: Womack, Steve [Rep.-R-AR-3]; Committees: House-Veterans’ Affairs

Posted on

HELP Committee Advances OAA Reauthorization

HELP Committee Advances OAA Reauthorization-The Senate Health, Education, Labor, and Pensions (HELP)Committee voted 20-1 to reauthorize the Older Americans Act (OAA) last week. Sen. Rand Paul (R-Ky.) was the sole vote in opposition to the reauthorization. Under S. 4776, the Older Americans Act Reauthorization Act of 2024, OAA programs would receive an almost 5% increase in authorized funding through fiscal year 2029. The Committee also advanced the Autism Collaboration, Accountability, Research, Education, and Support (Autism CARES) Act of 2024 (S.4762) and the Traumatic Brain Injury Program Reauthorization Act (S.4755) on a bipartisan basis.

 

 

HSGAC Advances Healthcare Cybersecurity Act-The Senate Homeland Security and Governmental Affairs Committee (HSGAC) advanced the Healthcare Cybersecurity Act (S.4697) in a 10-1 vote last week with Sen. Rand Paul (R-Ky.) voting against the bill. This legislation directs the Cybersecurity and Infrastructure Security Agency (CISA) and the U.S. Department of Health and Human Services (HHS) to collaborate on improving cybersecurity and make resources available to non-federal entities relating to cyber threat indicators and appropriate defense measures. It would also create a special liaison to HHS within CISA to coordinate during cybersecurity incidents and collaborate to support health care and public health sector entities.

 

 

Senate Appropriators Advance FY25 LHHS Bill-The Senate Appropriations Committee approved its fiscal year (FY) 2025 Labor-Health and Human Services (LHHS) spending measure last week in a bipartisan 25-3 vote. Sens. Deb Fischer (R-Neb.), Marco Rubio (R-Fla.), and Bill Hagerty (R-Tenn.) voted in opposition the legislation and Sen. John Hoeven (R-N.D.) did not vote. The bill provides $122.8 billion in discretionary funding for HHS. The National Institutes of Health would receive $50.2 billion, an increase of $2.05 billion over current levels. The bill sustains $1.5 billion in funding for the Advanced Research Projects Agency for Health. The Centers for Disease Control and Prevention would see a funding increase of $173 million over FY24 levels. The bill includes $3.82 billion for the Administration for Strategic Preparedness and Response, an increase of $200 million over FY24. More information can be found in the bill summary, bill text, and report.

 

 

The Senate’s bill stands in stark contrast to the House of Representative’s FY25 LHHS spending bill, which would cut HHS funding by 7% and provide flat funding for the NIH while proposing structural reforms. The House had planned to bring their version of the bill to the floor for a vote, but instead adjourned early for August recess when it became clear the measure did not have enough support for passage. Lawmakers are expected to begin negotiations on a stopgap spending measure when both chambers return from recess in September.

 

 

Comer Requests CMS Briefing on OPO Guidance-House Oversight Committee Chairman James Comer (R-Ky.) has sent a letter to the administration regarding its failure to issue guidance on the future of low performing organ procurement organizations (OPOs). The Centers for Medicare and Medicaid Services (CMS) finalized a rule in 2020 that would decertify the lowest performing-Tier 3-OPOs in 2026 based on their 2024 performance if they have failed to show improvement. CMS has yet to release guidance outlining how this decertification process would proceed or how higher performing OPOs should prepare to take over additional service areas. Approximately 42% of OPOs operated at the Tier 3 level in 2021, the most recent year with available data. “CMS’ inaction has created lack of clarity, increased uncertainty for Americans who need a transplant, and threatens to erode accountability for OPOs,” Comer writes. He requests a briefing from the agency that includes a description of the steps CMS is taking to ensure the final rule is implemented “without dilution or delay.”

 

 

Foxx Opposes Mental Health Parity Regulations-House Education and the Workforce Committee Chair Virginia Foxx (R-N.C.) sent a letter to the White House urging the administration to drop its proposed mental health parity rule. The rule is aimed at improving mental health coverage in commercial insurance plans by requiring parity between physical and mental health care in “non-quantitative treatment limitations” such as prior authorization. Foxx asserts that the rule lacks clarity and fails to consider workforce shortages amongst mental health professionals, arguing that it would actually decrease access to mental health treatment by disincentivizing employers from offering coverage. She also questions whether the rule exceeds agency authority in light of the Supreme Court’s overturning of the Chevron Deference.

 

 

Bucshon Remarks on VALID Act Status-Rep. Larry Bucshon, M.D. (R-Ind.) commented on the future of diagnostics reform legislation last week, appearing optimistic about the chances for bill passage in the next several years. The Food and Drug Administration (FDA) finalized a regulation earlier this year to provide greater oversight of laboratory developed tests (LDTs) within the agency’s existing medical device framework. Bucshon is the co-author of the bipartisan VALID Act (H.R.2369), which would create a new risk-based framework for the review of diagnostics and LDTs. Bucshon stated that many stakeholders’ opposition to the FDA rule has brought more parties back to the negotiating table on the VALID Act, and that the Supreme Court’s recent Chevron decision could result in litigation challenging the rule. Bucshon, who is retiring at the end of this year, has not yet secured a Republican to replace him alongside VALID Act co-lead Rep. Diana DeGette (D-Colo.).

 

 

Release of Senate 340B Bill Delayed-The release of legislation in the Senate to reform the 340B drug pricing program has been stalled, with the bill now not expected to be introduced until after the August recess. Sen. John Thune (R-S.D.) had previously expressed hopes that the bill would be rolled out last week, but its release was delayed by unspecified disagreements between Republican and Democratic members of the chamber’s bipartisan 340B working group. “It’s clear that we need a little more time to get this across the finish line,” GOP members of the working group-Sens. Thune, Jerry Moran (Kan.), and Shelley Moore Capito (W-Va.)-said in a statement.

 

 

CMS Releases FY25 IPPS Final Rule-Hospital payments will increase by $3.2 billion next year under the FY 2025 Medicare Hospital Inpatient Prospective Payment System (IPPS) final rule released by CMS last week. The 2.9% increase will take effect October 1 and is in line with CMS’ initial proposed rule. The regulation also finalizes a separate IPPS payment for small, independent hospitals to establish and maintain a buffer stock of essential medicines. The agency asserts that such facilities are particularly vulnerable to supply disruptions, and that buffer stocks will help guard against future shortages. CMS’ fact sheet on the final rule can be found here.

 

 

Congressional Retirements and Resignations-Rep. Bob Good (R-Va.) was defeated by former Navy SEAL officer John McGuire in the Republican primary following a recount for Virginia’s 5th congressional district. Good was first elected to Congress in 2020 and serves on the Education and Workforce and Budget committees. He is currently the chairman of the House Freedom Caucus.

 

 

A running list of members of Congress who are retiring or seeking other office can be found below.

 

SENATE
Stabenow (D), MI Braun (R), IN
Cardin (D), MD Romney (R), UT
Carper (D), DE
Butler (D), CA
Manchin (D), WV
Sinema (I), AZ
Menendez (D), NJ (effective Aug. 20, 2024)
HOUSE OF REPRESENTATIVES
Porter (D), CA Mooney (R), WV
Lee (D), CA Banks (R), IN
Gallego (D), AZ Bishop (R), NC
Schiff (D), CA Lesko (R), AZ
Slotkin (D), MI Granger (R), TX
Allred (D), TX Burgess, MD (R), TX
Trone (D), MD Wenstrup, DPM (R), OH
Blunt Rochester (D), DE McHenry (R), NC
Napolitano (D), CA Johnson (R), OH (effective Jan. 21, 2024)
Wexton (D), VA Ferguson, IV, DMD, PC (R), GA
Kim, Andy (D), NJ Curtis (R), UT
Jackson, Jeff (D), NC Luetkemeyer (R), MO
Sarbanes (D), MD Lamborn (R), CO
Blumenauer (D), OR Bucshon, MD (R), IN
Kilmer (D), WA Pence (R), IN
Spanberger (D), VA Duncan (R), SC
Kildee (D), MI Armstrong (R), ND
Phillips (D), MN McMorris Rodgers (R), WA
Cardenas (D), CA Gallagher (R), WI (effective April 19, 2024)
Eshoo (D), CA LaTurner (R), KS
Manning (D), NC Graves (R), LA
Nickel (D), NC
Ruppersberger (D), MD
Sablan (D), MP
Kuster (D), NH
Bowman (D), NY

 

 

Upcoming Congressional Hearings and Markups

Senate HELP Committee hearing “Why Is Novo Nordisk Charging Americans with Diabetes and Obesity Outrageously High Prices for Ozempic and Wegovy?”10:00 a.m.; September 24

 

 

Recently Introduced Health Legislation

H.R.9179-To amend title 38, United States Code, to establish the Office of Falls Prevention of the Department of Veterans Affairs, and for other purposes; Sponsor: Budzinski, Nikki [Rep.-D-IL-13]; Committees: House-Veterans’ Affairs; Education and the Workforce

 

S.4827-A bill to improve transparency and the availability of information regarding dietary supplements by amending the Federal Food, Drug, and Cosmetic Act to require manufacturers of dietary supplements to list dietary supplements with the Food and Drug Administration; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate-Health, Education, Labor, and Pensions

 

S.4829-A bill to direct the Administrator of the Centers for Medicare & Medicaid Services to clarify that implanted active middle ear hearing devices are prosthetics and are not subject to the hearing aid coverage exclusion under the Medicare program; Sponsor: Klobuchar, Amy [Sen.-D-MN]; Committees: Senate-Finance

 

S.Res.775-A resolution expressing support for the designation of July 15, 2024, as “National Leiomyosarcoma Awareness Day”; Sponsor: Stabenow, Debbie [Sen.-D-MI]; Committees: Senate-Health, Education, Labor, and Pensions

 

S.4831-A bill to amend the Older Americans Act of 1965 to include peer supports as a supportive service within the National Family Caregiver Support Program, to require States to consider the unique needs of caregivers whose families have been impacted by substance use disorder, including opioid use disorder, in providing services under such program, and for other programs; Sponsor: Budd, Ted [Sen.-R-NC]; Committees: Senate-Health, Education, Labor, and Pensions

 

S.4835-A bill to amend the Employee Retirement Income Security Act of 1974, title XXVII of the Public Health Service Act, and the Internal Revenue Code of 1986 to require group health plans and health insurance issuers offering group or individual health insurance coverage to provide for 3 primary care visits and 3 behavioral health care visits without application of any cost-sharing requirement; Sponsor: King, Angus S., Jr. [Sen.-I-ME]; Committees: Senate-Health, Education, Labor, and Pensions

 

S.4845-A bill to lower the cost of all drugs for all Americans; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate-Health, Education, Labor, and Pensions

 

S.4847-A bill to require the Secretary of Defense to conduct a study on active military-civilian partnerships at trauma centers of military medical treatment facilities within the Defense Health Agency; Sponsor: Cortez Masto, Catherine [Sen.-D-NV]; Committees: Senate-Armed Services

 

S.4855-A bill to amend the Older Americans Act of 1965 to authorize the provision of appropriate training, resources, and best practices to the aging network under grants for projects that address negative health effects associated with social isolation among older individuals; Sponsor: Murphy, Christopher [Sen.-D-CT]; Committees: Senate-Health, Education, Labor, and Pensions

 

S.4860-A bill to amend title XVIII of the Social Security Act to establish coverage for certain residential substance use disorder services under the Medicare program; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate-Finance

 

S.4862-A bill to ensure that new advances in artificial intelligence are ethically adopted to improve the health of all individuals, and for other purposes; Sponsor: Rounds, Mike [Sen.-R-SD]; Committees: Senate-Health, Education, Labor, and Pensions

 

H.R.9184-To amend title XI of the Social Security Act to exclude from antikickback and other sanctions certain travel and lodging arrangements between manufacturers of drugs and individuals being administered such drugs, and for other purposes; Sponsor: Guthrie, Brett [Rep.-R-KY-2]; Committees: House-Energy and Commerce; Ways and Means

 

H.R.9186-To amend title 10, United States Code, to ensure that medical records of the Department of Defense indicate the organizational affiliation of certain health care providers; Sponsor: Arrington, Jodey C. [Rep.-R-TX-19]; Committees: House-Armed Services

 

H.R.9194-To amend the Research and Development, Competition, and Innovation Act to support nucleic acid screening, and for other purposes; Sponsor: Caraveo, Yadira [Rep.-D-CO-8]; Committees: House-Science, Space, and Technology

 

H.R.9218-To establish a clear and consistent biological definition of male and female; Sponsor: Miller, Mary E. [Rep.-R-IL-15]; Committees: House-Judiciary

 

H.R.9232-To amend title XVIII of the Social Security Act to establish coverage for certain residential substance use disorder services under the Medicare program; Sponsor: Underwood, Lauren [Rep.-D-IL-14]; Committees: House-Ways and Means

 

H.R.9233-To amend the Public Health Service Act to require the Secretary of Health and Human Services to establish a program for the conduct and support of research, training, and health information dissemination with respect to environmental risk factors of neurodegenerative diseases, and for other purposes; Sponsor: Wexton, Jennifer [Rep.-D-VA-10]; Committees: House-Energy and Commerce

 

S.4878-A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate-Health, Education, Labor, and Pensions

 

S.4879-A bill to prioritize funding for an expanded and sustained national investment in biomedical research; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate-Appropriations

 

S.4905-A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes; Sponsor: Reed, Jack [Sen.-D-RI]; Committees: Senate-Health, Education, Labor, and Pensions

 

S.4918-A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the personal importation of safe and affordable drugs from approved pharmacies in Canada; Sponsor: Klobuchar, Amy [Sen.-D-MN]; Committees: Senate-Health, Education, Labor, and Pensions

 

S.Res.794-A resolution designating September 25, 2024, as “National Ataxia Awareness Day”, and raising awareness of ataxia, ataxia research, and the search for a cure; Sponsor: Hyde-Smith, Cindy [Sen.-R-MS]; Committees: Senate-Judiciary

 

S.Res.799-A resolution supporting the goals and ideals of Fentanyl Prevention and Awareness Day on August 21, 2024; Sponsor: Grassley, Chuck [Sen.-R-IA]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

S.4923-A bill to amend title IV of the Social Security Act to require States to provide information about available benefits and services to kinship caregivers; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate-Finance

 

S.4935-A bill to amend title XVIII of the Social Security Act to update the budget neutrality threshold under the Medicare physician fee schedule; Sponsor: Boozman, John [Sen.-R-AR]; Committees: Senate-Finance

 

S.4937-A bill to require Senate approval before the United States assumes any obligation under a WHO pandemic agreement and to suspend funding for the WHO until such agreement is ratified by the Senate; Sponsor: Barrasso, John [Sen.-R-WY]; Committees: Senate-Foreign Relations

 

S.4942-A bill making appropriations for the Departments of Labor, Health and human Services, and Education, and related agencies for the fiscal year ending September 30, 2025, and for other purposes; Sponsor: Baldwin, Tammy [Sen.-D-WI]; Committees: Senate-Appropriations

 

S.4949-A bill to improve end-of-life care; Sponsor: Blumenthal, Richard [Sen.-D-CT]; Committees: Senate-Health, Education, Labor, and Pensions

 

S.4957-A bill to amend the Public Health Service Act to provide for a health care workforce innovation program; Sponsor: Wyden, Ron [Sen.-D-OR]; Committees: Senate-Health, Education, Labor, and Pensions

 

S.4964-A bill to provide for a comprehensive Federal response to Long COVID, including research, education, and support for affected individuals, to direct the National Institutes of Health to establish a Long COVID research program, and for other purposes; Sponsor: Sanders, Bernard [Sen.-I-VT]; Committees: Senate-Health, Education, Labor, and Pensions

 

S.4968-A bill to improve the Institutional Development Award program of the National Institutes of Health; Sponsor: Hyde-Smith, Cindy [Sen.-R-MS]; Committees: Senate-Health, Education, Labor, and Pensions

 

S.4984-A bill to amend the Controlled Substances Act to require regulated persons to identify tableting machines and encapsulating machines by serial number; Sponsor: Cornyn, John [Sen.-R-TX]; Committees: Senate-Judiciary

 

S.4987-A bill to codify Chevron deference; Sponsor: Wyden, Ron [Sen.-D-OR]; Committees: Senate-Homeland Security and Governmental Affairs