Republicans in the House of Representatives elected Rep. Mike Johnson (R-La.) to serve as the next Speaker of the House on Wednesday, ending a three-week impasse that stalled all legislative work in the chamber. Johnson was first elected to the House in 2016, having previously worked as a senior counsel for the Alliance Defending Freedom and as a former state legislator. The Alliance Defending Freedom was involved in the recent legal case that overturned Roe v. Wade, and is now leading the push to restrict access to abortion medication. Johnson himself has sponsored a bill that would ban all abortions past 15 weeks, and has signed on as a cosponsor of legislation to codify the Hyde amendment which prohibits the use of federal funds to pay for abortion, except to save the life of the mother, or if the pregnancy is the result of incest or rape. Johnson previously served as chair of the conservative Republican Study Committee. During this time, he backed a budget proposal to raise the Medicare eligibility age to 67 and to endorse site neutral payments in the Medicare program. In 2019, he led an effort to replace Obamacare with high-risk pools, to roll back Medicaid expansion in favor of per-capita caps on the program, and to expand the use of health savings accounts. Johnson is a longstanding opponent of gender affirming care for children, and has been critical of the Centers for Disease Control and Prevention’s handing of the COVID-19 pandemic. Johnson was one of former President Donald Trump’s top allies on the Hill during his efforts to overturn Joe Biden’s 2020 presidential election victory.

 

The new Speaker is a strong advocate of cutting government spending. While he voted against the most recent continuing resolution (CR), Johnson has indicated that he is open to the next stopgap spending bill extending government funding for as long as five months. Johnson plans to pursue votes on eight spending bills ahead of the November 17 deadline to fund the federal government. If a CR is needed, Johnson has stated his intent to propose one that expires on January 15 or April 15 “to ensure the Senate cannot jam the House with a Christmas omnibus.”

 

Congress faces an effective April 30 deadline to pass fiscal year (FY) 2024 funding, given that the most recent debt ceiling agreement included a provision to subject all discretionary spending to a 1% cut should a CR still be in place past that date. The House successfully passed its Energy-Water spending bill (H.R. 4394) by a 210-199 vote last week. The House is expected to vote on Legislative Branch, Interior-Environment, and Transportation-Housing and Urban Development (HUD) appropriations the week of October 30; Financial Services and Commerce-Justice-Science the week of November 6; and Labor-Health and Human Services (HHS)-Education and Agriculture-Food and Drug Administration (FDA) the week of November 13. This plan would involve skipping committee markup of the Commerce-Justice-Science and Labor-HHS-Education bills and bringing them straight to the floor. Johnson’s plans also involve the establishment of a working group to negotiate the Agriculture-FDA bill, which was pulled from floor consideration earlier this year due to Republican in-fighting over total spending levels and a restriction that would prevent the abortion medication mifepristone from being dispensed via the mail.

 

Senate appropriators have marked up all 12 of their annual spending bills with bipartisan support, and aim to pass their first three-bill minibus comprised of Agriculture-FDA, Military Construction-Veterans Affairs, and Transportation-HUD measures (H.R. 4366) in the coming days.

 

HELP Advances NIH Nominee

The Senate Health, Education, Labor and Pensions (HELP) Committee voted to advance the nomination of Dr. Monica Bertagnolli to serve as the Director of the National Institutes of Health (NIH) in a bipartisan 15-6 vote last week. Chairman Bernie Sanders (I-Vt.) voted against the nomination, stating that he was not convinced she is prepared “to take on the greed and power of the drug companies and health care industry.” Earlier in the week, Sanders sent a letter to Christi Grimm, U.S. Department of Health and Human Services Inspector General, asking her office to investigate an exclusive patent license granted by the NIH to for a cervical cancer treatment. “I am growing increasingly alarmed that not only has the NIH abdicated its authority to ensure that the new drugs it helps develop are reasonably priced, it may actually be exceeding its authority to grant monopoly licenses to pharmaceutical companies that charge the American people, by far, the highest prices in the world for prescription drugs,” Sanders states. He suggests that the NIH should instead offer nonexclusive licenses so that more companies can manufacture the treatment at a lower cost to patients.

 

Budget Panel Task Force Considers Changes to CBO’s Scoring Methods

The House Budget Committee Health Care Task Force held its inaugural member roundtable last week to discuss the Congressional Budget Office’s (CBO) methods for analyzing policies that impact drug development in the U.S. Participants discussed how the agency developed its estimates of the Inflation Reduction Act’s impact on patient access to cures. The Task Force aims to ensure that CBO’s future analyses capture additional factors and subsequent real-world effects of policies impacting medical innovation across the nation.

 

House Members Urge Administration to Reconsider Nursing Home Staffing Rule

Agroup of 100 bipartisan members of the House of Representatives are urging the Biden administration to reconsider its proposed nursing home staffing requirements. The new rule from the Centers for Medicare and Medicaid Services would increase the on-site registered nurse staffing requirement to 24 hours and mandate that nursing homes provide 2.45 hours of care per resident day from nurse aides and 0.55 hours per resident day from registered nurses. The lawmakers, led by Rep. Greg Pence (R-Ind.), assert that the regulation would result in “limited access to care for seniors, mandatory increases in state Medicaid budgets, and could most consequentially lead to widespread nursing home closures.”

 

Lawmakers Push for Marijuana Descheduling

Abipartisan group of lawmakers have sent a letter urging the Drug Enforcement Administration (DEA) to pursue a full descheduling of marijuana. The policymakers highlight the federal-state policy gap on cannabis faced by medical practices and other stakeholders. “While Congress works to send the President comprehensive cannabis legislation, the urgency of full descheduling should inform DEA’s position on overall cannabis reform and appropriate enforcement centered on advancing public safety, not unjust criminalization,” the letter states. “Marijuana’s continued inappropriate scheduling is both arcane and out-of-touch with the will of the American people.”

 

Comer Probes FTC Move to Block Illumina’s Acquisition of Grail

House Oversight Committee Chairman James Comer (R-Ky.) has sent a letter to the Federal Trade Commission (FTC) regarding the agency’s handling of Illumina Inc.’s attempted acquisition of Grail, a cancer test provider. The European Union ordered Illumina to unwind its acquisition of Grail earlier this month, following a similar move by the FTC to block the deal earlier this year. Comer argues that the “collusion” between the FTC and EU deserves further scrutiny, and requests records of communication between the U.S regulatory agency and its European counterparts. “The FTC’s actions set a bad precedent that emboldens foreign governments to attack American businesses,” the letter states. “By deferring to foreign entities’ approaches to certain transactions, the FTC is improperly denying U.S. businesses the due process rights they are entitled to before the FTC and American courts.”

 

AAP Releases New Medicaid/CHIP Policy Statement

The American Academy of Pediatrics (AAP) released a proposal last week to overhaul how Medicaid and the Children’s Health Insurance Program (CHIP) provide health care for the nation’s children. The recommendations are aimed at providing more consistent and equitable health insurance coverage under the programs across all 50 states. The proposal would combine Medicaid and CHIP into a single program, automatically enrolling all newborns and extending program eligibility to include individuals up to the age of 26, regardless of immigration status. It would also increase the income threshold for eligibility to 400% of the federal poverty level. AAP also suggests “an end to undervalued Medicaid payment, with rates at least comparable to prevailing Medicare rates and that support the full range of services needed to provide comprehensive care to children.”

 

Recently Introduced Health Legislation

H.Res.806 – Expressing support for the recognition of October 2023, as “World Menopause Awareness Month” and expressing the sense of the House of Representatives regarding global awareness and access to care during the menopausal transition and post-menopause; Sponsor: Blunt Rochester, Lisa [Rep.-D-DE-At Large]

 

H.Con.Res.74 – Expressing support for the Geneva Consensus Declaration on Promoting Women’s Health and Strengthening the Family and urging that the United States rejoin this historic declaration; Sponsor: Banks, Jim [Rep.-R- IN-3]

 

H.R.6020 – To amend the Public Health Service Act to eliminate consideration of the income of organ recipients in providing reimbursement of expenses to donating individuals, and for other purposes; Sponsor: Obernolte, Jay [Rep.-R- CA-23]

 

H.R.6023 – To amend title 38, United States Code, to provide for the retroactive payment of benefits for veterans with covered mental health conditions based on military sexual trauma, and for other purposes; Sponsor: Carbajal, Salud O. [Rep.-D-CA-24]

 

H.R.6028 – To amend the Controlled Substances Act regarding marihuana, and for other purposes; Sponsor: Mace, Nancy [Rep.-R-SC-1]

 

H.R.6029 – To provide Medicaid assistance to individuals and families affected by a disaster or emergency, and for other purposes; Sponsor: Panetta, Jimmy [Rep.-D-CA-19]

 

H.R.6030 – To amend title XVIII of the Social Security Act to provide an option for first responders age 50 to 64 who are separated from service due to retirement or disability to buy into Medicare; Sponsor: Phillips, Dean [Rep.-D-MN-3]

 

H.R.6033 – To require the Secretary of Health and Human Services to establish a task force to improve access to health care information technology for non-English speakers; Sponsor: Steel, Michelle [Rep.-R-CA-45]

 

H.R.6038 – To amend the Public Health Service Act to provide for a Reducing Youth Use of E-Cigarettes Initiative; Sponsor: Wasserman Schultz, Debbie [Rep.-D-FL-25]

 

S.3130 – A bill to amend the Indian Health Care Improvement Act to improve the recruitment and retention of employees in the Indian Health Service, restore accountability in the Indian Health Service, improve health services, and for other purposes; Sponsor: Barrasso, John [Sen.-R-WY]; Committees: Senate – Indian Affairs

 

S.3131 – A bill to amend title XI of the Social Security Act to expand and clarify the exclusion for orphan drugs under the Drug Price Negotiation Program; Sponsor: Barrasso, John [Sen.-R-WY]; Committees: Senate – Finance

 

H.Res.813 – Supporting the designation of October 23, 2023, as “AADC Deficiency Awareness Day”; Sponsor: Murphy, Gregory [Rep.-R-NC-3]; Committees: House – Energy and Commerce

 

H.R.6040 – To prohibit the use of Federal funds for gender transition in minors; Sponsor: Boebert, Lauren [Rep.-R- CO-3]; Committees: House – Education and the Workforce

 

H.R.6045 – To direct the Comptroller General of the United States to conduct a study and submit a report on the efficacy of Federal drug surveillance systems, and for other purposes; Sponsor: Caraveo, Yadira [Rep.-D-CO-8]; Committees: House – Energy and Commerce

 

S.3136 – A bill to amend title XIX of the Social Security Act to extend the requirement for State Medicaid plans to provide coverage for medication-assisted treatment; Sponsor: Hassan, Margaret Wood [Sen.-D-NH]; Committees: Senate – Finance

 

S.3137 – A bill to allow Americans to receive paid leave time to process and address their own health needs and the health needs of their partners during the period following a pregnancy loss, an unsuccessful round of intrauterine insemination or of an assisted reproductive technology procedure, a failed adoption arrangement, a failed surrogacy arrangement, or a diagnosis or event that impacts pregnancy or fertility, to support related research and education, and for other purposes; Sponsor: Duckworth, Tammy [Sen.-D-IL]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3138 – A bill to amend titles XIX and XXI of the Social Security Act to provide for 12-month continuous enrollment of individuals under the Medicaid program and Children’s Health Insurance Program; Sponsor: Brown, Sherrod [Sen.-D- OH]; Committees: Senate – Finance

 

S.3143 – A bill to establish postmarket reporting requirements for pharmaceuticals, and for other purposes; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3144 – A bill to protect survivors from brain injury by authorizing the Secretary of Health and Human Services to collect data on the prevalence of brain injuries resulting from domestic and sexual violence; Sponsor: Cortez Masto, Catherine [Sen.-D-NV]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3145 – A bill to amend the Public Health Service Act to authorize fellowships under the Minority Fellowship Program to be awarded for training for professionals in the addiction medicine field; Sponsor: Cornyn, John [Sen.-R-TX]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3157 – A bill to amend title XVIII of the Social Security Act to expand eligibility for incentives under the Medicare health professional shortage area bonus program to practitioners furnishing mental health and substance use disorder services; Sponsor: Stabenow, Debbie [Sen.-D-MI]; Committees: Senate – Finance

 

S.3158 – A bill to require the Secretary of Health and Human Services to issue guidance to States on strategies under Medicaid and CHIP to increase mental health and substance use disorder care provider education, training, recruitment, and retention; Sponsor: Stabenow, Debbie [Sen.-D-MI]; Committees: Senate – Finance

 

H.Res.815 – Expressing support for the recognition of October 26, 2023, as “Intersex Awareness Day”, and supporting the goals and ideals of Intersex Awareness Day; Sponsor: Balint, Becca [Rep.-D-VT-At Large]; Committees: House – Energy and Commerce; Education and the Workforce

 

H.Res.821 – Supporting the goals and ideals of “Creutzfeldt-Jakob Disease (CJD) Awareness Day;” Sponsor: Valadao, David G. [Rep.-R-CA-22]; Committees: House – Energy and Commerce

 

H.R.6078 – To amend the Public Health Service Acts to make community colleges eligible to participate in the Nurse Education, Practice, Quality, and Retention-Pathway to Registered Nurse Program, and for other purposes; Sponsor: Ciscomani, Juan [Rep.-R-AZ-6]; Committees: House – Energy and Commerce. A press release can be found here.

 

H.R.6088 – To require the National Academy of Sciences to establish a grant program to develop safe AI models and safe AI research, and for other purposes; Sponsor: Kiley, Kevin [Rep.-R-CA-3]; Committees: House – Science, Space, and Technology. A press release can be found here.

 

H.R.6094 – To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to refine the set of information sources for determining coverage of certain drugs and biologicals used in the treatment or management of a rare disease or condition, and for other purposes; Sponsor: Matsui, Doris O. [Rep.-D-CA-7]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.6103 – To allow Americans to receive paid leave time to process and address their own health needs and the health needs of their partners during the period following a pregnancy loss, an unsuccessful round of intrauterine insemination or of an assisted reproductive technology procedure, a failed adoption arrangement, a failed surrogacy arrangement, or a diagnosis or event that impacts pregnancy or fertility, to support related research and education, and for other purposes; Sponsor: Pressley, Ayanna [Rep.-D-MA-7]; Committees: House – Education and the Workforce; House Administration; Oversight and Accountability; Judiciary

 

H.R.6109 – To amend the Internal Revenue Code of 1986 to establish the generic drugs and biosimilars production credit, and for other purposes; Sponsor: Tenney, Claudia [Rep.-R-NY-24]; Committees: House – Ways and Means

 

H.R.6110 – To amend title XVIII of the Social Security Act to restore physician judgment to prescribe the appropriate mix of skilled modalities that constitute an intensive rehabilitation therapy program in an inpatient rehabilitation hospital or unit; Sponsor: Thompson, Glenn [Rep.-R-PA-15]; Committees: House – Ways and Means

 

H.R.6112 – To establish postmarket reporting requirements for pharmaceuticals, and for other purposes; Sponsor: Waltz, Michael [Rep.-R-FL-6]; Committees: House – Energy and Commerce; Ways and Means

The House of Representatives remains without a Speaker following a closed- door Republican conference vote on Friday to drop Rep. Jim Jordan (R-Ohio) as the party’s nominee. Jordan was unable to secure the support necessary to be elected over the course of three failed floor votes last week. The House GOP is expected to meet on Monday to hear from the new candidates seeking the position, and to vote as early as Tuesday on its next speaker- designate. The members currently running for the position include House Majority Whip Tom Emmer (R-Minn.), Republican Study Committee chairman Rep. Kevin Hern (R-Okla.), House Republican Vice Conference chairman Rep. Mike Johnson (R-La.), Rep. Pete Sessions (R-Texas), Rep. Austin Scott (R-Ga.), Rep. Byron Donalds (R-Fla.), Rep. Jack Bergman (R-Mich.), Rep. Dan Meuser (R-Pa.), and Rep. Gary Palmer (R-Ala.). The chamber has a significant agenda of items to tackle whenever a speaker is elected. The current continuing resolution (CR) funding the federal government expires November 17. Federal funding for community health centers and health workforce programs were also temporarily extended by the CR. Both the Pandemic All Hazards Preparedness Act (PAHPA) and the President’s Emergency Plan for AIDS Relief (PEPFAR) program authorizations expired on September 30, with only certain PAHPA authorities temporarily extended by the CR.

 

HELP to Vote on NIH Nominee This Week

President Joe Biden’s nominee to serve as Director of the National Institutes of Health (NIH) Dr. Monica Bertagnolli declined to specify what steps she would take to lower drug prices during her confirmation hearing before the Senate Health, Education, Labor, and Pensions (HELP) Committee last week. Chairman Bernie Sanders (I-Vt.) asked the nominee whether she would commit to reinstating and expanding the reasonable pricing clause in NIH contracts. While Bertagnolli agreed that taxpayers deserve a fair return on their investment, she did not explicitly commit to whether she would, or would not, use the reasonable pricing clause if confirmed. The HELP Committee is scheduled to vote on Bertagnolli’s nomination on Wednesday.

 

Senators Launch Mental Health Caucus

Sens. Alex Padilla (D-Calif.), Thom Tillis (R-N.C.), Tina Smith (D-Minn.), and Joni Ernst (R-Iowa) announced the launch of a new bipartisan Mental Health Caucus last week. The 10-member caucus will focus on addressing health care workforce issues, raising awareness of the 988-crisis hotline, and effectively implementing the Bipartisan Safer Communities Act. The other members of the caucus include Sens. Cory Booker (D-N.J.), Shelley Moore Capito (R-W.Va.), Susan Collins (R-Maine), John Fetterman (D-Pa.), Amy Klobuchar (D-Minn.), and Lisa Murkowski (R-Alaska).

 

Lawmakers Comment on Biden Administration’s Proposed Changes to Mental Health Parity Requirements

Leadership of the House Education and Workforce Committee have weighed in on the Biden administration’s proposed expansion of mental health parity requirements. The regulation builds on the Mental Health Parity and Addiction Equity Act by mandating that insurers analyze the outcomes of their coverage policies. In her comments submitted on the proposed rule, Chair Virginia Foxx (R-N.C.) argued that the regulation “will serve only to weaken parity compliance by given prominence to bureaucratic reporting, paperwork, and audits.” Ranking Member Bobby Scott (D-Va.) and Health Subcommittee Ranking Member Mark DeSaulnier (D-Calif.), however, expressed support for the proposed rule and urged the administration to further limit the exceptions to the non-quantitative treatment limitation requirements contemplated by the proposal.

 

CA Sen. Butler Will Not Seek a Full Term

Sen. Laphonza Butler (D-Calif.) has confirmed that she will not run for a full Senate term in 2024. Butler, a labor leader and consultant, was recently appointed to fill the seat of the late Dianne Feinstein. Senate Majority Leader Chuck Schumer (D-N.Y.) confirmed last week that Sen. Butler will take the late Feinstein’s seat on the Judiciary Committee. Sen. Kyrsten Sinema (I-Ariz.) will take her place on the Appropriations Committee and Sen. Mark Kelly (D-Ariz.) will fill her seat on the Intelligence panel.

 

CMS Rejects More than 300 Misleading MA Ads

The Centers for Medicare and Medicaid Services (CMS) rejected more than 300 misleading advertisements for Medicare Advantage (MA) plans in the lead-up to this year’s open enrollment period. For the first time, and in response to complaints about MA ads, the agency reviewed more than 1,700 ads between May and September. Of the more than 250 ads submitted by third-party marketing organizations, 192 were rejected. Plans were permitted to start advertising on October 1st ahead of open enrollment, which runs from October 15 through December 7. The Senate Finance Committee convened a hearing on the subject of deceptive MA marketing practices on Wednesday and heard testimony from the Ohio Department of Insurance, Security Health Plan, and Chapter, a technology-enabled Medicare and retirement navigation platform.

 

Upcoming Congressional Hearings and Markups

House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic “Reforming the WHO: Ensuring Global Health Security and Accountability;” 10:00 a.m.; October 24

 

Senate Health, Education, Labor, and Pensions Committee executive session to consider the nomination of Monica Bertagnolli to be Director of the National Institutes of Health; 10:00 a.m.; October 25

 

House Energy and Commerce Subcommittee on Health hearing “Supporting Access to Long-Term Services and Supports: An Examination of the Impacts of Proposed Regulations on Workforce and Access to Care;” 2:00 p.m.; October 25

 

Senate Veterans’ Affairs Committee hearing “VA Accountability and Transparency: A Cornerstone of Quality Care and Benefits for Veterans;” 3:30 p.m.; October 25

 

Senate Specialty Committee on Aging hearing “Unlocking Hope: Access to Therapies for People with Rare, Progressive, and Serious Diseases;” 10:00 a.m.; October 26

 

Senate Committee on Health, Education, Labor, and Pensions field hearing “Overworked and Undervalued: Is the Severe Hospital Staffing Crisis Endangering the Well-Being of Patients and Nurses?;” 9:00 a.m.; October 27

 

Recently Introduced Health Legislation

H.R.5958 – To amend title XI of the Social Security Act to require that direct-to-consumer advertisements for drugs and biologicals include an appropriate disclosure of pricing information. Sponsor: Spanberger, Abigail Davis [Rep.-D-VA-7]

 

H.R.5957 – To amend the Public Health Service Act to establish a program of research regarding the risks posed by the presence of dioxins, phthalates, pesticides, chemical fragrances, and other components of menstrual products and intimate care products. Sponsor: Meng, Grace [Rep.-D-NY-6]

 

H.Res.784 – Supporting the designation of October 15, 2023, as “National Pregnancy and Infant Loss Remembrance Day” and recognizing the people who have lost a pregnancy or an infant. Sponsor: Schneider, Bradley Scott [Rep.-D-IL-10]

 

S.3048 – A bill to amend the Family and Medical Leave Act of 1993 to prohibit an employer from recovering any health care premium paid by the employer for an employee if the employee fails to return to work due to the birth of a child, and for other purposes; Sponsor: Vance, J. D. [Sen.-R-OH]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3059 – A bill to amend title XVIII of the Social Security Act to establish provider directory requirements, and to provide accountability for provider director accuracy, under Medicare Advantage; Sponsor: Bennet, Michael F. [Sen.-D-CO]; Committees: Senate – Finance

 

S.3060 – A bill to establish a Youth Mental Health Research Initiative in the National Institutes of Health for purposes of encouraging collaborative research to improve youth mental health; Sponsor: Klobuchar, Amy [Sen.-D-MN]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.Res.792 – Expressing support for the designation of October 17, 2023, as “National Vitiligo Awareness Day”; Sponsor: Johnson, Henry C. “Hank,” Jr. [Rep.-D-GA-4]

 

H.R.5975 – To authorize grants to implement school-community partnerships for preventing substance use and misuse among youth; Sponsor: Sánchez, Linda T. [Rep.-D-CA-38]

 

H.R.5976 – To establish a Youth Mental Health Research Initiative in the National Institutes of Health for purposes of encouraging collaborative research to improve youth mental health; Sponsor: Watson Coleman, Bonnie [Rep.-D-NJ-12]

 

S.3069 – A bill to amend title XVIII of the Social Security Act to provide coverage for custom fabricated breast protheses following a mastectomy; Sponsor: Duckworth, Tammy [Sen.-D-IL]; Committees: Senate – Finance

 

S.3070 – A bill to amend the SUPPORT for Patients and Communities Act to reauthorize the youth prevention and recovery initiative; Sponsor: Peters, Gary C. [Sen.-D-MI]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.5984 – To authorize the Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration, to award grants for expanding, modernizing, or streamlining emergency room operations; Sponsor: Lawler, Michael [Rep.-R-NY-17]

 

S.3085 – A bill to establish a program for purposes of carrying out programs to prevent adverse childhood experiences and promoting positive childhood experiences, and to require the Secretary of Health and Human Services to conduct studies, evaluations, and research to address adverse childhood experiences, including through the promotion of positive childhood experiences; Sponsor: King, Angus S., Jr. [Sen.-I-ME]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3090 – A bill to amend titles XIX and XXI of the Social Security Act to improve Medicaid and the Children’s Health Insurance Program for low-income mothers; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Finance

 

S.3091 – A bill to amend title XVIII of the Social Security Act to permit certain clinics to qualify as a rural emergency hospital under the Medicare program; Sponsor: Murkowski, Lisa [Sen.-R-AK]; Committees: Senate – Finance

 

S.3098 – A bill to amend title XIX of the Social Security Act to make permanent the Medicaid option to remove the IMD exclusion to provide medical assistance for certain individuals who are patients in an institution for mental diseases; Sponsor: Thune, John [Sen.-R-SD]; Committees: Senate – Finance

 

S.3103 – A bill to amend the Fair Credit Reporting Act to prohibit the inclusion of medical debt on a consumer report, and for other purposes; Sponsor: Merkley, Jeff [Sen.-D-OR]; Committees: Senate – Banking, Housing, and Urban Affairs

 

H.R.6003 – To amend the Fair Credit Reporting Act to prohibit the inclusion of medical debt on a consumer report, and for other purposes; Sponsor: Porter, Katie [Rep.-D-CA-47]

 

H.R.6004 – To amend titles XIX and XXI of the Social Security Act to improve Medicaid and the Children’s Health Insurance Program for low-income mothers; Sponsor: Pressley, Ayanna [Rep.-D-MA-7]

The House of Representatives remains without a speaker following the ousting of Kevin McCarthy (R-Calif.) on October 3. On Friday, Rep. Jim Jordan (R-Ohio) became the House GOP’s new nominee for speaker following a closed- door 124-81 vote. Speaker designate Steve Scalise (R-La.) dropped out of the race on Thursday after it became clear that he did not have enough support amongst Republican lawmakers to be elected on the floor. Scalise had previously beat out Jordan to earn the GOP conference nomination in a 113-99 vote earlier in the week. Any nominee will need to receive 217 votes to win the speakership on the floor. House Minority Leader Hakeem Jeffries (D-N.Y.) stated over the weekend that “informal conversations” are taking place regarding a bipartisan solution to the chamber’s current speaker situation. Over the weekend, House Republican Leadership announced plans to vote on the election of the Speaker on Tuesday afternoon.

 

A group of centrist House Democrats have sent a letter to House Speaker Pro Tempore Patrick McHenry (R-N.C.) stating that they would back the temporary expansion of McHenry’s authority to allow the chamber to take up urgent legislative matters, including government funding and foreign aid. The current continuing resolution expires on November 17, and the House is unable to vote on a government funding plan until a new speaker is elected. “In light of our nation’s pressing issues, a looming government shutdown, and the attacks on our key ally, Israel, we strongly support an immediate vote to expand the Speaker Pro Tempore’s authorities to all for the consideration of a legislative agenda limited to the most pressing issues,” the lawmakers said. They suggest the expansion of the speaker pro tempore’s authorities in 15-day increments until the election of a new speaker. The letter was signed by four leaders of the bipartisan Problems Solvers Caucus: Reps. Josh Gottheimer (D-N.J.), Ed Case (D-Hawaii), Susie Lee (D-Nev.), and Jared Golden (D-Maine).

 

GOP Doctors Caucus Release Proposal to Reform MPFS

The GOP Doctors Caucus released a discussion draft of legislation last week that would overhaul Medicare’s physician fee schedule (MPFS). The proposal would provide more flexibility around how much the Centers for Medicare and Medicaid Services can spend. The agency is currently restrained by a budget neutrality requirement. The bill would also update how the Medicare program calculates practice expense relative value units (RVUs). Practice expense RVUs have been on the decline since they were last addressed by Congress in 2015.

 

Blackburn Urges HHS to Affirm Parameters Around Patient Cost-Sharing

Sen. Marsha Blackburn (R-Tenn.) has sent a letter urging the U.S. Department of Health and Human Services (HHS) to affirm that patients’ prescription drug payments, including when financed through copay assistance, constitute cost- sharing, and should be treated as such. Blackburn cites data finding that manufacturer-funded copay assistance reduced Americans’ prescription drug costs by nearly $19 billion last year, and that forgone or delayed care due to accumulators and other comparable tools likely total between $1.3 billion and $2.5 billion annually. “By clarifying that cost-sharing, even when financed through a copay assistance program, still comprises cost-sharing, HHS could correct the legal defects of the 2021 Notice of Benefit and Payment Parameters and save patients tens of billions in out-of-pocket costs,” Blackburn argues.

 

HELP Dems Release Staff Report on Nonprofit Charity Care

Senate Health, Education, Labor and Pensions Committee Chairman Bernie Sanders (I-Vt.) has released a majority staff report asserting that major non-profit hospitals are prioritizing profits over spending on charity care. The Affordable Care Act requires nonprofit hospitals to establish financial assistance policies to care for patients who are unable to afford treatment. According to the report, between 2012 and 2019 nonprofit hospitals increased their average operating profits by 36% and nearly doubled their cash reserves, while their average spending on charity care decreased from $6.7 million to $6.4 million over the same period. Of the 16 largest nonprofit hospitals, 12 of them dedicated less than 2% of their total revenue to charity care, and half of those dedicated less than 1%. The report recommends mandating that tax-exempt hospitals provide a minimum level of charity care and suggests reforms to increase transparency around the reporting of community benefit data to the Internal Revenue Service.

 

Doc Caucus Comments on Proposed Nursing Home Staffing Requirements

The GOP Doctors Caucus is asking the Biden administration to reconsider its proposed rule regarding nursing home staffing requirements. The new rule from the Centers for Medicare and Medicaid Services would increase the on-site registered nurse staffing requirement to 24 hours and mandate that nursing homes provide 2.45 hours of care per resident day from nurse aides and 0.55 hours per resident day from registered nurses. The lawmakers express concerns that the “one-size-fits-all approach to staffing long-term care facilities, especially those in rural areas, is tone deaf to challenges they face.”

 

Upcoming Congressional Hearings and Markups

House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic hearing “Strengthening Biosafety and Biosecurity Standards: Protecting Against Future Pandemics;” 10:00 a.m.; October 18

 

House Science, Space, and Technology Subcommittee on Investigations and Oversight hearing “Balancing Knowledge and Governance: Foundations for Effective Risk Management of Artificial Intelligence;” 10:00 a.m.; October 18

 

House Energy and Commerce Subcommittee on Innovation, Data, and Commerce hearing “Safeguarding Data and Innovation: Building the Foundation for the Use of Artificial Intelligence;” 10:00 a.m.; October 18

 

Senate Committee on Health, Education, Labor, and Pensions hearing to examine the nomination of Monica M. Bertagnolli, of Massachusetts, to be Director of the National Institutes of Health; 10:00 a.m.; October 18

 

Senate Finance Committee hearing “Medicare Advantage Annual Enrollment: Cracking Down on Deceptive Practices and Improving Senior Experiences;” 10:00 a.m.; October 18 Senate Budget Committee hearing “Improving Care, Lowering Costs: Achieving Health Care Efficiency;” 10:00 a.m.; October 18

 

House Energy and Commerce Subcommittee on Environment, Manufacturing, and Critical Materials hearing “Exposing EPA Efforts to Limit Chemicals Needed for Life-Saving Medical Devices and Other Essential Products;” 10:30 a.m.; October 18

 

House Energy and Commerce Subcommittee on Health hearing “What’s the Prognosis?: Examining Medicare Proposals to Improve Patient Access to Care & Minimize Red Tape for Doctors;” 10:00 a.m.; October 19

 

House Veterans’ Affairs Subcommittee on Health hearing “Emerging Therapies: Breakthroughs in the Battle Against Suicide?” 1:30 p.m.; October 19

 

Senate Committee on Health, Education, Labor, and Pensions field hearing “Overworked and Undervalued: Is the Severe Hospital Staffing Crisis Endangering the Well-Being of Patients and Nurses?;” 9:00 a.m.; October 27

 

Recently Introduced Health Legislation

H.R.5910 – To prioritize educating and training for existing and new environmental health professionals. Sponsor: Thanedar, Shri [Rep.-D-MI-13]

 

H.R.5909 – To amend title XXVII of the Public Health Service Act to limit cost sharing for prenatal services in certain circumstances. Sponsor: Spanberger, Abigail Davis [Rep.-D-VA-7]

 

H.R.5906 – To amend title XI of the Social Security Act to exclude expenditures attributable to a State medicaid fraud control unit from the payment limits under Medicaid for Guam, the Northern Mariana Islands, and American Samoa. Sponsor: Sablan, Gregorio Kilili Camacho [Del.-D-MP-At Large]

 

H.R.5901 – To amend the Public Health Service Act to encourage programs to address college athlete mental health. Sponsor: Hudson, Richard [Rep.-R-NC-9]

 

H.R.5894 – Making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2024, and for other purposes. Sponsor: Aderholt, Robert B. [Rep.-R-AL-4]

 

H.Res.766 – Supporting the designation of October 7, 2023, as National Ostomy Awareness Day. Sponsor: Payne, Donald M., Jr. [Rep.-D-NJ-10]

 

H.Res.780 – Expressing support for the goals of “World Sight Day” by promoting the importance of accessible, affordable, and inclusive eye care; Sponsor: Veasey, Marc A. [Rep.-D-TX-33]

 

H.R.5924 – To amend title XVIII of the Social Sec

urity Act with respect to the timing of changes to the annual out-of- pocket threshold for the Medicare prescription drug benefit, and to amend title XI of such Act with respect to the timing of the Medicare drug price negotiation program; Sponsor: Magaziner, Seth [Rep.-D-RI-2]

 

H.Res.782 – Thanking and promoting the professions of perinatal nurses by encouraging participation in National Perinatal Nurses Week; Sponsor: Joyce, David P. [Rep.-R-OH-14]

 

H.R.5935 – To amend title XVIII of the Social Security Act to extend the Quality Payment Program-Small Practice, Underserved, and Rural Support program; Sponsor: Stansbury, Melanie Ann [Rep.-D-NM-1]

 

H.R.5938 – To amend the Veterans’ Benefits Improvements Act of 1996 and the Johnny Isakson and David P. Roe, M.D. Veterans Health Care and Benefits Improvement Act of 2020 to improve the temporary licensure requirements for contract health care professionals who perform medical disability examinations for the Department of Veterans Affairs, and for other purposes; Sponsor: Ciscomani, Juan [Rep.-R-AZ-6]

 

H.R.5948 – To terminate the Office of Gun Violence Prevention in the Executive Office of the President and prohibit the establishment of any similar successor office, and for other purposes; Sponsor: Rosendale Sr., Matthew M. [Rep.-R-MT-2]

Last week, eight conservative critics of Rep. Kevin McCarthy (R-Calif.) were joined by the House Democratic caucus in successfully ousting McCarthy as Speaker of the House in a 216-210 vote. The motion to vacate was brought to the floor by Rep. Matt Gaetz (R-Fla.) and supported by Republican Reps. Andy Biggs (Ariz.), Ken Buck (Colo.), Tim Burchett (Tenn.), Eli Crane (Ariz.), Bob Good (Va.), Nancy Mace (S.C.), and Matt Rosendale (Mont.). McCarthy is the first House speaker in history to be removed from the job. The GOP dissidents cited McCarthy’s support for the latest continuing resolution to prevent a government shutdown as the main reason for their campaign against him. Rep. Patrick McHenry (R-N.C.) has been tapped to serve as speaker pro-tempore, having been on the top of McCarthy’s secret list of successors, a practice initiated after 9/11 to protect the continuity of government. While the chamber cannot vote on legislation until a new speaker has been elected, McHenry now has the full power of speaker to sign enrolled bills and joint resolutions and usher the House through votes to elect a permanent replacement.

 

House Majority Leader Steve Scalise (R-La.) and Rep. Jim Jordan (R-Ohio), who both supported Speaker McCarthy in last week’s vote, have formally announced their candidacies to be the next Speaker. Both members are seen as ideologically to the right of McCarthy, with Jordan being considered the more conservative of the two. Jordan currently serves as chair of the House Judiciary Committee and is leading the GOP’s investigations into the current administration and Biden family. He recently voted against the continuing resolution to keep the government running through November 17, while Scalise voted in favor of it. Both candidates have focused on the need to address the fentanyl crisis and have criticized the Biden administration’s response to the COVID-19 pandemic. Jordan has been endorsed by former president Donald Trump. Gaetz has expressed support for both bids for speaker while emphasizing that a plan to reduce government spending is more important than the individual speaker themself.

 

The House GOP plans to hold a party conference on Tuesday to provide rank-and-file members the opportunity to ask questions of the candidates. The conference would then vote on their nominee for speakership. If a strong candidate emerges, McHenry plans to hold a floor vote to elect a new speaker on Wednesday. The next speaker faces a possible government shutdown when the current continuing resolution expires on November 17, as well as reauthorization of key health programs like the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), the Children’s Hospital Graduate Medical Education program, the Pandemic and All-Hazards Preparedness Act, and the SUPPORT Act, which expired last month.

 

GOP Senators Pledge to Block Bills Unrelated to Government Funding

Agroup of 20 Republican senators have sent a letter to Senate Majority Leader Chuck Schumer (D-N.Y.) pledging to withhold their support for any vote to proceed to items unrelated to the fiscal year 2024 appropriations process. “We urge you to present a plan to the Republican Conference for how you intend to pass the remaining appropriations bills and conference them with the House in a manner that respects an open amendment process and which does not end in a December omnibus spending package,” the letter states. The lawmakers highlight that limited time remains until government funding once again expires on November 17th.

 

Ways and Means Members Probe Implementation of Hospice Special Focus Program

Abipartisan group of House Ways and Means Committee members have sent a letter to the Biden administration regarding the Hospice Special Focus Program (SFP). The lawmakers assert that the Centers for Medicare and Medicaid Services’ (CMS) proposal for identifying poorly performing hospices is based on incomplete survey data and would “not adequately identify hospices that are truly struggling with performance.” The letter also encourages CMS to ensure Medicare-certified hospices get a preview of their performance under the SFP before the program is formally launched. The letter was signed by Reps. Beth Van Duyne (R-Texas), Earl Blumenauer (D-Ore.), Brad Wenstrup (R-Ohio), and Jimmy Panetta (D-Calif.).

 

Warren, Jayapal Urge Scrutiny of UnitedHealth, Amedisys Merger

Sen. Elizabeth Warren (D-Mass.) and Rep. Pramila Jayapal (D-Wash.) have requested that antitrust regulators examine UnitedHealth Group’s proposed acquisition of home health and hospice provider Amedisys Inc. The letter characterizes the deal as the “latest example of massive health care conglomerates using anti-competitive mergers to increase their market dominance, reducing competition, hurting patients, and increasing health care costs.” The lawmakers urge the Department of Justice to closely scrutinize the deal and to “oppose the growing trend of insurers buying up health care providers to reduce competition.”

 

Laphonza Butler Sworn in as Senator

California Governor Gavin Newsom (D) tapped Laphonza Butler, president of EMILY’s List, to fill the seat of the late Sen. Dianne Feinstein. EMILY’s List advocates for the election of Democratic, pro-choice women to political office. Butler previously served as president of SEIU Local 2015 in California, and has also worked as a partner at political consulting firm SCRB Strategies. Butler was sworn in by Vice President Kamala Harris on Tuesday, becoming only the third Black female senator in history. She is one of three LGBTQ senators currently in office. She has not yet indicated whether she will seek the office in the 2024 election.

 

CBO Issues Call for New Obesity Research

The Congressional Budget Office (CBO) is requesting new research to inform its analysis of obesity treatment policies, including the use of new anti-obesity medications. Medicare is currently prohibited from covering weight-loss drugs like Ozempic and Trulicity, but legislation – including the Treat and Reduce Obesity Act (S. 2407/H.R. 4818) – has been introduced to change that policy. CBO’s blog on the issue states that were Medicare to pay for these drugs some of the cost would be captured through higher premiums and patient cost sharing, but that the drugs’ net cost to the Medicare program would still be “significant” over the next decade.

 

DEA Extends COVID Telehealth Rules for Remote Prescribing

The Drug Enforcement Administration (DEA) has extended COVID-era flexibilities for the prescription of controlled substances via telemedicine through the end of 2024. The agency’s second temporary rule will allow all patients to be prescribed controlled substances without an in-person visit. DEA plans to issue new standards by fall 2024 that will “most effectively expand access to telemedicine encounters” while also preventing misuse.

 

Recently Introduced Health Legislation

S.Res.389 – A resolution expressing support for the annual designation of October 1st as “National Latino/a Physician Day”. Sponsor: Padilla, Alex [Sen.-D-CA]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.5864 – To amend title XIX of the Social Security Act to provide for coverage under the Medicaid program of non- invasive prenatal genetic screening; Sponsor: Fitzpatrick, Brian K. [Rep.-R-PA-1]; Committees: House – Energy and Commerce

 

H.R.5866 – To ensure comprehensive wraparound services for families impacted by substance use disorders, and for other purposes; Sponsor: Lee, Barbara [Rep.-D-CA-12]; Committees: House – Energy and Commerce; Ways and Means; Education and the Workforce

 

S.3006 – A bill to ensure comprehensive wraparound services for families impacted by substance use disorders, and for other purposes; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.Res.405 – A resolution expressing support for the designation of September 30, 2023, as “National Veterans Suicide Prevention Day;” Sponsor: Brown, Sherrod [Sen.-D-OH]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

S.3010 – A bill to amend title XVIII of the Social Security Act to provide coverage of medical nutrition therapy services for individuals with eating disorders under the Medicare program; Sponsor: Hassan, Margaret Wood [Sen.-D-NH]; Committees: Senate – Finance

 

S.3021 – A bill to amend title XVIII of the Social Security Act to permanently extend certain in-home cardiopulmonary rehabilitation flexibilities established in response to COVID-19, and for other purposes; Sponsor: Sinema, Kyrsten [Sen.-I- AZ]; Committees: Senate – Finance

 

S.3022 – A bill to amend the Indian Health Care Improvement Act to allow Indian Health Service scholarship and loan recipients to fulfill service obligations through half-time clinical practice, and for other purposes; Sponsor: Cortez Masto, Catherine [Sen.-D-NV]; Committees: Senate – Indian Affairs

Congress narrowly averted the threat of a federal government shutdown over the weekend following passage of a clean continuing resolution (CR) that funds the government through November 17. House Speaker Kevin McCarthy (R-Calif.) brought the bipartisan stopgap spending bill (H.R. 5860) to the floor on Saturday. It passed by a vote of 335-91, with 90 Republicans and one Democrat voting in opposition. The legislation extends fiscal year (FY) 2023 funding for 45 days. It also extends funding for several programs that were set to expire at the end of September, including the Community Health Center program, National Health Service Corps, Teaching Health Center Graduate Medical Education program, Special Diabetes Program, Special Diabetes Program for Indians, pandemic preparedness authorities, and delays scheduled cuts to Medicaid payments for disproportionate share hospitals. The bill reauthorizes animal drug user fees through FY 2028. The bill also includes the full $16 billion in disaster relief funding requested by the Biden administration, but does not include supplemental aid to Ukraine. It also struck a pay raise for Members of Congress that had been included in the Senate’s version of the temporary spending bill. The Senate voted 88-9 to concur with the House amendments to the CR. The Senate vote was reportedly delayed over concern regarding the elimination of funding for Ukraine. In calling up the vote, Senate Majority Leader Chuck Schumer (D-N.Y.) said that he and Minority Leader Mitch McConnell (R-Ky.) have “agreed to continue fighting for more economic and security aid for Ukraine.” President Joe Biden signed the measure into law late Saturday. Speaker McCarthy is expected to face a motion to vacate the chair this week from a small group of House Republicans seeking to oust him as speaker. The group, headed by Rep. Matt Gaetz (R-Fla.), opposed a bipartisan approach to government funding and sought to enact steep budgetary cuts.

 

Wyden, Pallone to Investigate Medicaid MCOs’ Use of Prior Authorization

Senate Finance Committee Chairman Ron Wyden (D-Ore.) and House Energy and Commerce Committee Ranking Member Frank Pallone (D-N.J.) sent a series of letters to the nation’s largest Medicaid managed care organizations (MCOs) regarding their high rates of care denials. The lawmakers are requesting details about the insurance carriers’ use of prior authorization, including any algorithms and reliance on artificial intelligence used to make prior authorization coverage decisions. The lawmakers highlight a recent finding from the Health and Human Services Office of the Inspector General which found that one in eight MCO prior authorization requests were denied, double the rate in the Medicare Advantage program. “It is critical that MCOs are not improperly denying access to care in an effort to maximize profits given that they are obligated by statute, regulation, and contracts with states to pay network providers for furnishing covered services to enrollees,” Pallone and Wyden write. “MCOs should not be prioritizing corporate or shareholder profits ahead of the health and well-being of American families.”

 

MA Premiums to Increase $0.64

The average premium for Medicare Advantage (MA) plans will increase from $17.86 to $18.50 per month in 2024, according to the latest estimates from the Centers for Medicare and Medicaid Services. The total number of MA plans will also increase, from 5,674 to 5,700. The agency projects that MA will account for more than half of all Medicare enrollment next year, with 33.8 million people expected to choose an MA plan during the upcoming open enrollment period, which opens on October 15 and closes December 7.

 

Cassidy Issues RFIs on Reforming CDC, NIH

Senate Health, Education, Labor and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-La.) is soliciting comments to inform potential legislation to modernize the Centers for Disease Control and Prevention (CDC). Cassidy specifically seeks input on four high-level topics – fostering innovation and collaboration, making data work for everyone, improving upon what works well, and mechanisms to modernize – as well as other relevant information. Cassidy’s request for information (RFI) mirrors a similar request for feedback issued by the House Energy and Commerce Committee in April. Comments should be submitted no later than October 20th via email to [email protected].

Cassidy also issued an RFI on ways to reform the National Institutes of Health (NIH). Specifically, the HELP Ranking Member is seeking information on how the NIH could improve its process for approving federal research grants, better support the biomedical research workforce, bolster collaboration across academia and industry, and increase transparency into agency activities. The deadline to submit feedback to [email protected] is October 27th.

 

FDA Proposes LDT Enforcement Rule

The Food and Drug Administration (FDA) released a proposal last week that would result in most laboratory developed tests (LDTs) being subject to agency review as medical devices. The rule is aimed at ensuring the safety, accuracy, and effectiveness of LDTs. It seeks to amend the FDA’s regulations to make explicit that in vitro diagnostic products (IVDs), including LDTs, are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory. Along with this amendment, the FDA is proposing a policy under which the FDA intends to provide greater oversight of LDTs through a five-stage, multi-year phaseout of its current general enforcement discretion approach. The FDA estimates that the proposed rule would save the health care system more than $22.3 billion and the FDA $5.6 billion annually. Comments on the proposed rule are due by December 1, 2023.

 

Administration to Begin Enforcement of Drug Price Reporting Requirements

The departments of Health and Human Services, Labor, and Treasury have issued joint guidance regarding the enforcement of drug price reporting requirements for health insurers. The departments announced their decision to rescind a 2021 regulation that had delayed enforcement of the drug pricing provisions of the Trump-era transparency in coverage rule. That regulation requires health insurers to publicly disclose the negotiated rates of covered prescription drugs in machine readable files. Going forward, the Biden administration plans to address enforcement of the requirements on a case-by-case basis, and does not plan to issue further rulemaking in the near future.

 

Medicare Drug Price Negotiations to Proceed

Federal Judge Michael J. Newman denied a request to halt Medicare drug price negotiations while litigation challenging the process is ongoing. The lawsuit, brought by the U.S. Chamber of Commerce and other local and state chambers of commerce, argued that the Inflation Reduction Act violates the First, Fifth, and Eighth amendments of the Constitution. In its defense of the law, the Justice Department asserted that the Chamber and its members cannot show imminent harm and questioned whether the Chamber had standing to bring its case. “The Court is not convinced that granting Plaintiffs preliminary injunctive relief will protect them from imminent and irreparable harm,” Newman wrote in his opinion. “Any economic harm – which, on its own, is insufficient to satisfy this prong of a preliminary injunction analysis – will not occur for years in the future.” Pharmaceutical manufacturers of the 10 drugs selected for the first round of negotiation had until October 1st to agree to participate in the process, to withdraw their products from the Medicare program, or to face excise taxes. While companies are not required to announce their decision to opt into the program, Merck, Boehringer Ingelheim, AstraZeneca and Bristol Myers Squibb have publicly confirmed that they will participate in negotiations.

 

CBO Issues Report on CMMI

The Center for Medicare and Medicaid Innovation (CMMI) spent $7.9 billion operating care models that reduced spending by $2.6 billion, according to a new analysis by the Congressional Budget Office (CBO). Previous CBO forecasts had projected that CMMI would save $2.8 billion in its first decade of work, since its inception as a part of the Affordable Care Act in 2010. CBO now projects that CMMI will increase net federal spending by $1.3 billion over its second decade. CBO attributes CMMI’s performance to the slow pace at which successful models are scaled up and the voluntary nature of most pilot programs.

 

ARPA-H Announces Cambridge, Dallas as Latest Hubs

The Advanced Research Projects Agency for Health (ARPA-H) announced the selection of its next two headquarters last week. ARPA-H’s customer experience hub will be in Dallas and its investor catalyst hub will be in Cambridge, Mass. Dallas and Cambridge join Washington, D.C., which will serve as the stakeholder and operations hub, as a part of the new agency’s hub-and-spoke model. ARPA-H continues to recruit a network of regional private, public, and nonprofit organizations to serve as spokes, with 10 spokes having been announced so far.

 

Earlier in the week, ARPA-H announced the award of almost $115 million for three new cancer research programs. Rice University will receive up to $45 million for the development of an implant to sense and deliver specific doses of medicine to increase cancer therapy response rates. The University of Missouri will receive up to $9 million for the development of a cancer therapy that uses engineered bacteria to target tumors’ immune cells to treat cancer without the traditional side effects of cancer treatment. The Georgia Institute of Technology and Emory University will receive up to $50 million to develop biosensor tools to recognize cancer-specific biomarkers, with the goal of identifying cancers when they are at their most treatable.

 

Ways and Means Passes Legislation to Expand Use of HSAs

The House Ways and Means Committee advanced the Bipartisan HSA Improvement Act (H.R. 5688) last week. The bill passed the committee in a 28-14 vote, with four Democrats joining Republicans in voting in support of the measure. The legislation would allow individuals who utilize direct primary care arrangements and worksite health clinics to contribute to a health savings account (HSA). The panel also advanced the HSA Modernization Act (H.R. 5687) along a party line vote. The bill would expand eligibility for HSAs to Medicare beneficiaries who are still working and veterans, allow spouses to make catch-up contributions to the same HSA, and increase the limits on contributions.

 

Senate Committee Advances SAFER Banking Act

The Senate Banking Committee advanced legislation last week that would enable the nation’s cannabis businesses to access banking services more easily. The SAFER Banking Act (S. 2860) would create a safe harbor for banks, credit unions, and payment processors that provide services to state-sanctioned businesses. The legislation aims to promote public safety by reducing cannabis businesses’ reliance on cash and increasing access to deposit accounts, insurance, other financial services.

 

Democrats Push for Opioid Settlement Fund Oversight

Agroup of 12 congressional Democrats have sent a letter to the Office of National Drug Control Policy regarding oversight of the more than $50 billion states will receive in opioid settlement money over the next 15 years. The letter, spearheaded by Sen. Ed Markey (D-Mass.) and Rep. David Trone (D-Md.), argues that the funds must be spent on substance use disorder treatment and prevention, not on other general state expenditures. “This funding, drawn from the profits that pharmaceutical companies made by overprescribing opioids and underselling their potential dangers, presents a significant opportunity to redistribute ill-gained earnings to the people who the opioid epidemic harmed,” the lawmakers state. “We must take full advantage of these settlements to combat this crisis, therefore we urge the Biden administration to closely track opioid settlement fund spending, to ensure that populations in need of additional support receive it and to avoid duplicative federal efforts.”

 

Sen. Dianne Feinstein Dies at 90

Six-term California Democratic Senator Dianne Feinstein, 90, passed away at her home in Washington on Friday. She was the chamber’s longest serving female senator. Feinstein sat on four committees prior to her death: Appropriations, Judiciary, Intelligence, and Rules. Senate Democrats are expected to select a member to replace her in the coming days to maintain their majority on each panel. Feinstein had already announced that she would not be running for a seventh term in 2024. California Governor Gavin Newsom will be responsible for appointing Feinstein’s successor. Newsom has stated that he will appoint a Black woman, but that he will not appoint anyone already running for the position so as not to interfere in the primary race. He has also confirmed that his appointee will be free to run for a full Senate term in 2024, should they choose to do so. Reps. Barbara Lee (D-Calif.), Katie Porter (D-Calif.), and Adam Schiff (D-Calif.), along with former Google executive Lexi Reese, have announced their candidacies for the 2024 Senate race.

 

POLICY BRIEFINGS

 

NJ Democrat to Challenge Menendez for Senate Seat

Rep. Andy Kim (D-N.J.) plans to challenge Sen. Bob Menendez (D-N.J.) for his seat in the upper chamber next year. Kim’s announcement follows the indictment of the three-term Senator on charges of corruption. Menendez will step down as chair of the Foreign Relations Committee, but has pleaded not guilty to charges that he accepted bribes in exchange for helping the Egyptian government. Menendez has stated that he will not resign, but it is unclear whether he would cooperate with a Senate ethics investigation. He faces mounting calls from both Republicans and Democratic colleagues in Congress to step down.

 

Insurers Commit to COVID Shot Coverage With No Cost Sharing

Representatives of the nation’s major health insurance carriers sent a letter to U.S. Department of Health and Human Services Secretary Xavier Becerra last week assuring him that Americans can access the latest COVID-19 booster without any out-of-pocket costs. “Throughout this transition to traditional public and private reimbursement, our members prepared and have been working tirelessly to overcome system challenges and increase access. We value the collaboration with your teams as we work together to continue to expand access to the updated COVID vaccines through more routine channels,” the letter states. “You have our commitment that health insurers are fully covering the new COVID-19 shots, as required, with no cost sharing when consumers access them from a network provider or receive them through an out-of-network provider when in-network options are unavailable.”

 

Upcoming Congressional Hearings and Markups

Senate Veterans’ Affairs Committee hearing “VA Accountability and Transparency: A Cornerstone of Quality Care and Benefits for Veterans;” 3:00 p.m.; October 4

 

Recently Introduced Health Legislation

S.Res.367 – A resolution designating September 2023 as “National Spinal Cord Injury Awareness Month”; Sponsor: Rubio, Marco [Sen.-R-FL]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

S.Res.368 – A resolution supporting the designation of the week of September 17 through September 23, 2023, as “Telehealth Awareness Week”; Sponsor: Schatz, Brian [Sen.-D-HI]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

S.Res.369 – A resolution expressing support for the designation of September 2023 as “Sickle Cell Disease Awareness Month” in order to educate communities across the United States about sickle cell disease and the need for research, early detection methods, effective treatments, and preventative care programs with respect to complications from sickle cell disease and conditions related to sickle cell disease; Sponsor: Scott, Tim [Sen.-R-SC]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

S.2916 – A bill to provide for digital communication of prescribing information for drugs (including biological products), and for other purposes; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2918 – A bill to reauthorize the program of surveillance and education regarding infections associated with illicit drug use and other risk factors; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2922 – A bill to advance population research for chronic pain; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2932 – A bill to direct the Secretary of Health and Human Services to provide guidance to State Medicaid agencies, public housing agencies, Continuums of Care, and housing finance agencies on connecting Medicaid beneficiaries with housing-related services and supports under Medicaid and other housing resources, and for other purposes; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Finance

 

S.2933 – A bill to reauthorize the program of first responder training; Sponsor: Baldwin, Tammy [Sen.-D-WI]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.Res.725 – Expressing support for the designation of September 30, 2023, as “Rare Cancer Day” to highlight the challenges patients with rare cancers face and to raise awareness and support efforts to improve early diagnosis and treatment; Sponsor: Kelly, Mike [Rep.-R-PA-16]; Committees: House – Energy and Commerce

 

H.Res.728 – Expressing support for the designation of September 2023 as “Peripheral Artery Disease Awareness Month”; Sponsor: Payne, Donald M., Jr. [Rep.-D-NJ-10]; Committees: House – Oversight and Accountability

 

H.R.5687 – To amend the Internal Revenue Code of 1986 to modernize health savings accounts; Sponsor: Van Duyne, Beth [Rep.-R-TX-24]; Committees: House – Ways and Means

 

H.R.5688 – To amend the Internal Revenue Code of 1986 to improve health savings accounts; Sponsor: Smucker, Lloyd [Rep.-R-PA-11]; Committees: House – Ways and Means

 

H.R.5690 – To amend the Internal Revenue Code of 1986 to allow for certain distributions from a health savings account for medical expenses incurred during the 60-day period before the account was established; Sponsor: Moore, Blake D. [Rep.-R-UT-1]; Committees: House – Ways and Means

 

H.R.5697 – To direct the Secretary of Veterans Affairs to ensure veterans may obtain a physical copy of a certain form by mail or at medical facilities of the Department of Veterans Affairs, and for other purposes; Sponsor: Bilirakis, Gus M. [Rep.-R-FL-12]; Committees: House – Veterans’ Affairs

 

H.R.5699 – To provide programs to assist diagnosis, awareness, and education of blood clot conditions, and for other purposes; Sponsor: Blunt Rochester, Lisa [Rep.-D-DE-At Large]; Committees: House – Energy and Commerce

 

H.R.5708 – To amend the Federal Food, Drug, and Cosmetic Act to extend a priority review program to encourage treatments for agents that present national security threats; Sponsor: Finstad, Brad [Rep.-R-MN-1]; Committees: House – Energy and Commerce

 

H.R.5709 – To amend the Internal Revenue Code of 1986 to allow individuals entitled to Medicare Part A to make contributions to health savings accounts; Sponsor: Fischbach, Michelle [Rep.-R-MN-7]; Committees: House – Ways and Means

 

H.R.5713 – To amend the Controlled Substances Act to authorize Homeland Security Investigations to perform certain drug enforcement functions, and for other purposes; Sponsor: Higgins, Clay [Rep.-R-LA-3]; Committees: House – Ways and Means; Judiciary; Energy and Commerce

 

H.R.5716 – To amend the Internal Revenue Code of 1986 to allow contributions to a health savings account when a spouse has a health flexible spending account; Sponsor: LaHood, Darin [Rep.-R-IL-16]; Committees: House – Ways and Means

 

H.R.5737 – To amend the Internal Revenue Code of 1986 to increase the maximum contribution limit for health savings accounts; Sponsor: Van Duyne, Beth [Rep.-R-TX-24]; Committees: House – Ways and Means

 

H.R.5740 – To amend the Higher Education Act of 1965 to promote comprehensive campus mental health and suicide prevention plans, and for other purposes; Sponsor: Wild, Susan [Rep.-D-PA-7]; Committees: House – Education and the Workforce

 

S.2939 – A bill to amend title XVIII of the Social Security Act to require reporting on enforcement and oversight of pharmacy access requirements under Medicare part D; Sponsor: Blackburn, Marsha [Sen.-R-TN]; Committees: Senate – Finance

 

S.2941 – A bill to amend title XVIII of the Social Security Act to provide coverage of preventative home visits under Medicare, and for other purposes; Sponsor: King, Angus S., Jr. [Sen.-I-ME]; Committees: Senate – Finance

 

S.2942 – A bill to amend title XVIII of the Social Security Act to improve the annual wellness visit under the Medicare program; Sponsor: King, Angus S., Jr. [Sen.-I-ME]; Committees: Senate – Finance

 

S.2946 – A bill to amend the Public Health Service Act to provide funding for trained school personnel to administer drugs and devices for emergency treatment of known or suspected opioid overdose, and for other purposes; Sponsor: Merkley, Jeff [Sen.-D-OR]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2948 – A bill to require the Secretary of Labor to issue guidance and regulations regarding opioid overdose reversal medication and employee training; Sponsor: Merkley, Jeff [Sen.-D-OR]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2954 – A bill to apply the Medicaid asset verification program to all applicants for, and recipients of, medical assistance in all States and territories, and for other purposes; Sponsor: Barrasso, John [Sen.-R-WY]; Committees: Senate – Finance

 

H.Res.732 – Expressing support for the designation of September 30, 2023, through October 7, 2023, as “National Student Athlete Mental Health Week”; Sponsor: Carl, Jerry L. [Rep.-R-AL-1]; Committees: House – Education and the Workforce

 

H.Res.734 – Expressing support for the designation of October 1 as “National Latino and Latina Physician Day”; Sponsor: Ruiz, Raul [Rep.-D-CA-25]; Committees: House – Energy and Commerce

 

H.R.5746 – To amend title XVIII of the Social Security Act to expand the availability of supplemental benefits to certain Medicare Advantage enrollees; Sponsor: Bilirakis, Gus M. [Rep.-R-FL-12]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.5749 – To amend the Public Health Service Act with regard to research on asthma, and for other purposes; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House – Energy and Commerce

 

H.R.5752 – To amend the Internal Revenue Code of 1986 to allow first-dollar coverage of mental health services for purposes of health savings accounts; Sponsor: Fitzpatrick, Brian K. [Rep.-R-PA-1]; Committees: House – Ways and Means

 

H.R.5762 – To direct the Secretary of Health and Human Services to research and design a graphic symbol to indicate when linguistic access materials and services are available for a health program, product, or service, and for other purposes; Sponsor: Kim, Young [Rep.-R-CA-40]; Committees: House – Energy and Commerce

 

H.R.5773 – To amend the Public Health Service Act to remove certain liability protections for certain biological products and other drugs if the sponsor thereof fails to disclose to the public all non-exempt data within the biological product file or drug application, and for other purposes; Sponsor: Posey, Bill [Rep.-R-FL-8]; Committees: House – Energy and Commerce

 

H.R.5774 – To amend the Internal Revenue Code of 1986 to clarify the treatment of distributions from health savings accounts for long-term care services; Sponsor: Smith, Adrian [Rep.-R-NE-3]; Committees: House – Ways and Means

 

H.R.5777 – To amend the Internal Revenue Code of 1986 improve health savings accounts; Sponsor: Wenstrup, Brad R. [Rep.-R-OH-2]; Committees: House – Ways and Means

 

S.Res.381 – A resolution supporting the designation of the week of August 28 through September 1, 2023, as “National Community Health Worker Awareness Week”; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.Res.384 – A resolution recognizing the seriousness of polycystic ovary syndrome (PCOS) and expressing support for the designation of September 2023 as “PCOS Awareness Month”; Sponsor: Warren, Elizabeth [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2966 – A bill to amend the Public Health Service Act to encourage programs to address college athlete mental health; Sponsor: Boozman, John [Sen.-R-AR]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2973 – A bill to amend titles XVIII and XIX of the Social Security Act to establish requirements relating to pharmacy benefit managers under the Medicare and Medicaid programs, and for other purposes; Sponsor: Wyden, Ron [Sen.-D-OR]; Committees: Senate – Finance

 

S.2978 – A bill to authorize funding for the establishment and implementation of infant mortality pilot programs in standard metropolitan statistical areas with high rates of infant mortality, and for other purposes; Sponsor: Van Hollen, Chris [Sen.-D-MD]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2993 – A bill to amend the Social Security Act and the Public Health Service Act to permanently authorize certified community behavioral health clinics, and for other purposes; Sponsor: Stabenow, Debbie [Sen.-D-MI]; Committees: Senate – Finance

 

H.Res.740 – Expressing support for the designation of September 30, 2023, as “National Veterans Suicide Awareness and Prevention Day”; Sponsor: Joyce, David P. [Rep.-R-OH-14]; Committees: House – Oversight and Accountability

 

H.R.5782 – To ensure access to cost-free rabies postexposure prophylaxis; Sponsor: Bera, Ami [Rep.-D-CA-6]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.5787 – To amend the Internal Revenue Code of 1986 to allow, without regard to disability, individuals eligible for veterans benefits to contribute to health savings accounts; Sponsor: Carey, Mike [Rep.-R-OH-15]; Committees: House – Ways and Means

 

H.R.5788 – To amend the Public Health Service Act to promote healthy eating and physical activity among children; Sponsor: Cohen, Steve [Rep.-D-TN-9]; Committees: House – Energy and Commerce

 

H.R.5789 – To authorize funding for the creation and implementation of infant mortality pilot programs in standard metropolitan statistical areas with high rates of infant mortality, and for other purposes; Sponsor: Cohen, Steve [Rep.-D- TN-9]; Committees: House – Energy and Commerce

 

H.R.5794 – To amend title 38, United States Code, to eliminate conflicts of interest in conduct of quality management and administrative investigations by the Veterans Health Administration, and for other purposes; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House – Veterans’ Affairs

 

H.R.5796 – To prohibit the Secretary of Health and Human Services from finalizing a proposed rule regarding minimum staffing for nursing facilities, and to establish an advisory panel on the nursing home workforce; Sponsor: Fischbach, Michelle [Rep.-R-MN-7]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.5804 – To authorize the Secretary of Health and Human Services to make loans and loan guarantees for planning, constructing, or renovating pediatric or adult mental health treatment facilities and pediatric or adult substance use disorder treatment facilities, and for other purposes; Sponsor: Kilmer, Derek [Rep.-D-WA-6]; Committees: House – Energy and Commerce

 

H.R.5806 – To amend title 18, United States Code, to prohibit chemical abortions, and for other purposes; Sponsor: Ogles, Andrew [Rep.-R-TN-5]; Committees: House – Judiciary

 

H.R.5818 – To amend title XVIII of the Social Security Act to expand coverage of the in-home administration of intravenous immune globulin under the Medicare program; Sponsor: Smith, Adrian [Rep.-R-NE-3]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.5819 – To amend title XVIII of the Social Security Act to provide incentives for behavioral health integration under the Medicare program; Sponsor: Steel, Michelle [Rep.-R-CA-45]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.5821 – To amend the Internal Revenue Code of 1986 to provide for a credit against tax for expenses for translational research regarding neurodegenerative diseases and psychiatric conditions; Sponsor: Thompson, Mike [Rep.-D-CA-4]; Committees: House – Ways and Means