Senate Passes Legislation Aimed at Patent Thickets

July 15, 2024

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Senate Passes Legislation Aimed at Patent Thickets-The Senate passed the Affordable Prescriptions for Patients Act (S.150) by unanimous consent last week. The legislation aims to prevent the creation of patent thickets by pharmaceutical manufacturers by limiting the number of patents a drugmaker can use in patent infringement litigation against biosimilar competition. The version of the bill passed by the Senate last week cut a previously included provision that would have also prohibited product hopping by brand name companies seeking to limit generic competition. The bill, introduced by Sens. Richard Blumenthal (D-Conn.) and John Cornyn (R-Texas), would save an estimated $1.8 billion in federal spending over the next decade. The savings created by the bill could be used as a potential pay-for in a year-end health care package.

Appropriations Update-The Senate Appropriations Committee approved its fiscal year (FY) 2025 Agriculture-Food and Drug Administration (FDA) spending bill in a 27-0 vote last week. The bill would fund the FDA at $6.87 billion, a $22 million increase over FY2024 discretionary spending levels. House appropriators also advanced their Agriculture-FDA spending bill last week, which would fund the FDA at $6.75 billion. The bill was passed on a party line vote of 29-26.

The House Appropriations Committee approved its FY2025 Labor-Health and Human Services-Education (LHHS) spending bill in a 31-25 vote. The $185.8 billion measure represents an 11% cut compared to current funding levels. The U.S. Department of Health and Human Services would receive $107 billion in funding, a 7% cut. The House LHHS spending bill would hold NIH funding at current levels while proposing significant restructuring. Budgets for the Advanced Research Projects Agency for Health (ARPA-H) and Centers for Disease Control and Prevention (CDC) would be severely reduced, and funding for the Agency for Healthcare Quality and Research (AHRQ) would be completely eliminated.

The FY2025 Legislative Branch spending bill was defeated on the House floor last week, with 10 Republicans joining Democrats in voting against the bill in opposition to a provision that would have extended a 15-year pay freeze for members of Congress. Senate appropriators advanced their Legislative Branch measure out of committee in a 27-0 vote on Thursday. The Senate bill also proposes to keep member pay at its current level.

In addition to adopting top-line allocations for the 12 annual appropriations measures, Senate appropriators have also reached an agreement to increase the amount of FY 2025 emergency spending to $34.5 billion, with nondefense funding receiving $13.5 billion. Lawmakers have until September 30 to fund the federal government. Republican leadership in the House aim to pass all 12 annual appropriations bills on the House floor before the August recess, with Appropriations Chairman Tom Cole (R-Okla.) asserting that doing so will give the chamber a leg up on eventual government funding negotiations with the Senate. Cole has indicated that a continuing resolution will likely be necessary to keep the government open beyond the end of the fiscal year.

New FTC Report on PBM Industry-The Federal Trade Commission (FTC) released an interim staff report on pharmacy benefit managers (PBMs) last week. The report is a part of the agency’s ongoing inquiry into the role of prescription drug middlemen that was launched in 2022. FTC highlights the concentration and vertical integration that exists within the PBM services market, finding that the top three PBMs process nearly 80% of the approximately 6.6 billion prescriptions dispensed by U.S. pharmacies in 2023, and the top six PBMs process more than 90%. The report details how this consolidation allows PBMs to exercise significant influence over access to and affordability of prescription drugs, and outlines PBMs’ use self-preferencing, unfair contract terms, and efforts to limit access to low-cost competition. According to the Wall Street Journal, the FTC plans to sue Express Scripts, Caremark, and OptumRx for their negotiating tactics related to certain drugs, including insulin.

In response to the report, Senate Finance Committee Chair Ron Wyden (D-Ore.) highlighted his panel’s unanimous advancement of PBM reform legislation last November, stating he is “going to the mat to deliver that bill to the president’s desk this year.” Rep. Buddy Carter (R-Ga.), who has spearheaded legislative efforts to overhaul the PBM industry in the House, called on the FTC to “promptly complete its investigation and begin enforcement actions if-and when-it uncovers illegal and anticompetitive PBM practices.” It was reported last week that executives from CVS Caremark, Express Scripts, and OptumRx have agreed to testify before the House Oversight Committee in a hearing scheduled for July 23.

Speaker Johnson Promises September Vote on BIOSECURE-House Speaker Mike Johnson (R-La.) stated his intention to bring the BIOSECURE Act (H.R.8333) to the floor for a vote this September. The bill will be considered as a part of Johnson’s effort “to have a significant package of China-related legislation signed into law by the end of this year, this Congress.” The legislation would prohibit Chinese biotechnology companies of concern from receiving federal contracts, grants, or loans and is aimed at blocking foreign governments from accessing Americans’ health and genomic data. Both the House and Senate versions of the bill were advanced out of committee earlier this year.

GOP Committee Leaders Write Agencies in Wake of Chevron Decision-Republican committee leadership in the House of Representatives have written to more than two dozen federal agencies, including the U.S. Department of Health and Human Services, requesting a list of rules and adjudications that could be impacted by the Supreme Court’s recent decision to overturn the Chevron deference. The letters did not outline any specific regulations that the GOP intends to challenge, but did highlight the administration’s efforts around the climate, energy sector, and environmental, social, and governance (ESG) investing as based on “aggressive interpretations of statutes.” “We intend to ensure agencies are held accountable following the court’s ruling and observe the proper checks on their power,” House Majority Leader Steve Scalise (R-La.) said in a statement. Republicans request responses from federal agencies by the end of the month.

Rep. Garamendi Begins Treatment for Multiple Myeloma-Rep. John Garamendi (D-Calif.) has begun treatment for multiple myeloma. Garamendi stated that he expects to continue working but will limit travel to Washington and public events throughout the treatment process. “Today, I started my path to remission with chemo-immunotherapy as an outpatient at Kaiser Oncology in Sacramento,” Garamendi stated on Monday. “I’m grateful our President initiated the Cancer Moonshot and that California’s efforts in stem cell research and taxing cigarettes in the 1980s for cancer research have advanced therapies benefiting not only me, but every family dealing with cancer.”

AMA Releases New Survey Data on Physician Burnout-New survey data from the American Medical Association (AMA) show that U.S. physician burnout has fallen below 50% for the first time since 2020. Approximately 48% of physicians report feeling burnout last year, down from 53% in 2022 and from a record high rate of 63% in 2021. The AMA’s survey of more than 12,400 physicians from 81 organizations across 31 states requested input on six performance indicators: job satisfaction, job stress, burnout, intent to leave an organization, feeling valued by an organization, and total hours spent per week on work-related activities. The AMA found that between 2022 and 2023, physician job satisfaction improved, job stress decreased, and more physicians feel valued by their organizations.

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

Upcoming Congressional Hearings and Markups

House Veterans’ Affairs Subcommittee on Technology Modernization hearing “Report Card: Assessing Electronic Health Record Modernization at the Captain James A. Lovell Federal Health Care Center;” 4:30 p.m.; July 22

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

S.4630-A bill to establish an interagency committee to harmonize regulatory regimes in the United States relating to cybersecurity, and for other purposes; Sponsor: Peters, Gary C. [Sen.-D-MI]; Committees: Senate-Homeland Security and Governmental Affairs

S.4635-A bill to require a report and updated guidance on continued risk management for pharmaceutical supply chains of Department of Defense; Sponsor: Peters, Gary C. [Sen.-D-MI]; Committees: Senate-Armed Services

H.R.8942-To amend the Indian Health Care Improvement Act to ensure that certain employees, providers, and volunteers associated with the Indian Health Service receive educational training in the history and culture of the Tribes served by such persons, and for other purposes; Sponsor: Hageman, Harriet M. [Rep.-R-WY-At Large]; Committees: House-Natural Resources; Energy and Commerce

H.R.8948-To amend title 18, United States Code, to limit the ability to assess a fee for health care services for prisoners, and for other purposes; Sponsor: Norton, Eleanor Holmes [Del.-D-DC-At Large]; Committees: House-Judiciary

S.Res.757-A resolution designating the week of May 5, 2024, through May 11, 2024, as “Tardive Dyskinesia Awareness Week”; Sponsor: Mullin, Markwayne [Sen.-R-OK]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

S.4641-A bill to provide for certain reforms pertaining to Chevron deference; Sponsor: Cotton, Tom [Sen.-R-AR]; Committees: Senate-Homeland Security and Governmental Affairs

H.R.8955-To amend the Indian Health Care Improvement Act to ensure that, whenever the Indian Health Service undertakes an investigation into the professional conduct of a licensee of a State, the Service notifies the relevant State medical board, and for other purposes; Sponsor: Johnson, Dusty [Rep.-R-SD-At Large]; Committees: House-Natural Resources; Energy and Commerce

H.R.8956-To amend the Indian Health Care Improvement Act for the development and implementation of a centralized system to credential licensed health professionals who seek to provide health care services at any Indian Health Service unit; Sponsor: Newhouse, Dan [Rep.-R-WA-4]; Committees: House-Natural Resources; Energy and Commerce

H.R.8964-To amend the HITECH Act to allow an individual to obtain a copy of such individual’s protected health information at no cost unless certain circumstances apply, and for other purposes; Sponsor: Foster, Bill [Rep.-D-IL-11]; Committees: House-Energy and Commerce

H.R.8966-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: Johnson, Dusty [Rep.-R-SD-At Large]; Committees: House-Natural Resources; Energy and Commerce; Ways and Means; Oversight and Accountability

S.Res.761-A resolution expressing support for the designation of the month of June 2024 as “National Post-Traumatic Stress Awareness Month” and June 27, 2024, as “National Post-Traumatic Stress Awareness Day”; Sponsor: Sullivan, Dan [Sen.-R-AK]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

S.4667-A bill to amend title 31, United States Code, to establish the Life Sciences Research Security Board, and for other purposes; Sponsor: Paul, Rand [Sen.-R-KY]; Committees: Senate-Homeland Security and Governmental Affairs

H.Res.1350-Expressing concern about the elevated levels of lead in one-third of the world’s children and the global causes of lead exposure, and calling for the inclusion of lead exposure prevention in global health, education, and environment programs abroad; Sponsor: Crow, Jason [Rep.-D-CO-6]; Committees: House-Foreign Affairs; Energy and Commerce

H.R.8977-To amend title XI of the Social Security Act to require the Center for Medicare and Medicaid Innovation to test an emergency medical services treatment-in-place model under the Medicare program; Sponsor: Carey, Mike [Rep.-R-OH-15]; Committees: House-Energy and Commerce; Ways and Means

H.R.8981-To amend the SUPPORT for Patients and Communities Act to improve trauma support services and mental health care for children and youth in educational settings, and for other purposes; Sponsor: Hayes, Jahana [Rep.-D-CT-5]; Committees: House-Education and the Workforce

H.R.8987-To amend title XXVII of the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to ensure cost sharing for a drug does not exceed the nationwide average of consumer purchase prices for such drug; Sponsor: Porter, Katie [Rep.-D-CA-47]; Committees: House-Energy and Commerce; Ways and Means; Education and the Workforce

S.Res.764-A resolution expressing support for the designation of July 2024 as “National Sarcoma Awareness Month”; Sponsor: Johnson, Ron [Sen.-R-WI]; Committees: Senate-Health, Education, Labor, and Pensions

S.4671-A bill to limit cost sharing for prescription drugs, and for other purposes; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate-Health, Education, Labor, and Pensions

S.4682-A bill to amend the Patient Protection and Affordable Care Act to establish a public health insurance option, and for other purposes; Sponsor: Whitehouse, Sheldon [Sen.-D-RI]; Committees: Senate-Health, Education, Labor, and Pensions

S.4684-A bill to ensure affordable health insurance coverage for low-income individuals in States that have not expanded Medicaid; Sponsor: Warnock, Raphael G. [Sen.-D-GA]; Committees: Senate-Finance

S.4690-An original bill making appropriations for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies for the fiscal year ending September 30, 2025, and for other purposes; Sponsor: Heinrich, Martin [Sen.-D-NM]; Committees: Senate-Appropriations

S.4691-A bill to amend the Internal Revenue Code of 1986 to deny the deduction for advertising and promotional expenses for prescription drugs; Sponsor: Shaheen, Jeanne [Sen.-D-NH]; Committees: Senate-Finance

S.4697-A bill to enhance the cybersecurity of the Healthcare and Public Health Sector; Sponsor: Rosen, Jacky [Sen.-D-NV]; Committees: Senate-Homeland Security and Governmental Affairs

S.4717-A bill to include pregnancy and loss of pregnancy as qualifying life events under the TRICARE program and to require a study on maternal health in the military health system, and for other purposes; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate-Armed Services

S.4724-A bill to amend title XXXIII of the Public Health Service Act with respect to flexibility and funding for the World Trade Center Health Program; Sponsor: Gillibrand, Kirsten E. [Sen.-D-NY]; Committees: Senate-Health, Education, Labor, and Pensions

H.Res.1356-Expressing support for the designation of October 9 through October 16, 2024, as “National Dyspraxia/Developmental Coordination Disorder (DCD) Awareness Week” and a commitment to raise awareness of dyspraxia/DCD in the United States; Sponsor: Lawler, Michael [Rep.-R-NY-17]; Committees: House-Energy and Commerce

H.J.Res.186-Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Federal Trade Commission entitled “Non-Compete Clause Rule”; Sponsor: Palmer, Gary J. [Rep.-R-AL-6]; Committees: House-Judiciary

H.R.8999-To amend title XVIII of the Social Security Act to provide coverage and payment under such title for certain treatments for dialysis-related amyloidosis, and for other purposes; Sponsor: Babin, Brian [Rep.-R-TX-36]; Committees: House-Energy and Commerce; Ways and Means

H.R.9001-To amend title XVIII of the Social Security Act to revise certain physician self-referral exemptions relating to physician-owned hospitals; Sponsor: Burgess, Michael C. [Rep.-R-TX-26]; Committees: House-Energy and Commerce; Ways and Means

H.R.9008-To amend the Public Health Service Act to require the Secretary to award grants, contracts, or cooperative agreements to eligible entities to establish, maintain, or improve activities related to the detection and monitoring of infectious diseases through wastewater for public health emergency preparedness and response purposes, and for other purposes; Sponsor: Garcia, Robert [Rep.-D-CA-42]; Committees: House-Energy and Commerce

H.R.9020-To amend the Patient Protection and Affordable Care Act to establish a public health insurance option, and for other purposes; Sponsor: Schakowsky, Janice D. [Rep.-D-IL-9]; Committees: House-Energy and Commerce

H.R.9021-To amend the Internal Revenue Code of 1986 to deny the deduction for advertising and promotional expenses for prescription drugs; Sponsor: Slotkin, Elissa [Rep.-D-MI-7]; Committees: House-Ways and Means

H.R.9022-To include pregnancy and loss of pregnancy as qualifying life events under the TRICARE program and to require a study on maternal health in the military heath system, and for other purposes; Sponsor: Stefanik, Elise M. [Rep.-R-NY-21]; Committees: House-Armed Services