Congressional:

Government Shutdown Enters Fourth Week

The government shutdown, which began on October 1, is on its 24th day. At the heart of the shutdown is a disagreement between Congressional Republicans and President Trump, who have pushed for a clean continuing resolution (CR) to fund the government on a short-term basis, and Democratic leaders who have demanded that any funding deal include the permanent extension of Affordable Care Act (ACA) enhanced advanced premium tax credits (APTCs), which are set to expire at the end of this year, along with a repeal of the Medicaid and ACA provisions included in Republican-passed H.R. 1. So far, the Senate has voted and failed to pass the House-passed CR (H.R. 5371) 12 times.

At present, there is no solution in sight. On Thursday, the Senate voted on a bill from Senator Ron Johnson (R-WI) to pay troops and some federal workers; however, it did not pass. Senate Majority Leader John Thune (R-SD) also took the step on Wednesday to make two other funding bills available for a vote, an additional bill to pay troops from Senator Dan Sullivan (R-AK) and a bill to pay Transportation Security Administration (TSA) employees and air traffic controllers from Senator Ted Cruz (R-TX).

In the House on Tuesday, 13 moderate Republicans urged party leadership to find a path to extend expiring enhanced health care tax credits once the government reopens. The Republican group wrote to Speaker Mike Johnson (R-LA), stating, "Let us be clear: significant reforms are needed to make these credits more fiscally responsible and ensure they are going to the Americans who need them most." The letter also noted that, "Our Conference and President Trump have been clear that we will not take healthcare away from families who depend on it. This is our opportunity to demonstrate that commitment through action." Read the letter here.

Senate HELP Committee Probes 340B Drug Pricing Program

On Thursday, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing examining the 340B drug pricing program. The 340B Drug Pricing Program requires drug manufacturers to provide discounts to facilities serving low-income and uninsured communities. During the hearing, senators from both parties said Congress needs to address the program. Chair Bill Cassidy (R-LA) expressed concern about the program, noting that it encourages physicians to prescribe more expensive drugs and leads to health care system consolidation. The Congressional Budget Office (CBO), which testified before the committee, published a report in September that attributed the 340B program’s growth to the integration of hospitals and off-site clinics, increased facility participation after the implementation of the Affordable Care Act, and expanded use of off-site pharmacies that dispense 340B drugs. Read the witness testimonies here.

Senate Special Aging Committee Holds Hearing on Shoppable Health Care Services

On Wednesday, the Senate Aging Committee held a hearing examining how price transparency and shoppable health care services could benefit consumers, increase competition, and reduce costs. During the hearing, Chair Rick Scott (R-FL) and Ranking Member Kristen Gillibrand (D-NY) highlighted the importance of transparency in shoppable services, such as prescription drugs and Affordable Care Act Marketplace plans. Senators asked the witnesses how increased price transparency has improved the quality of care and reduced the cost of shoppable services, and how the federal government can best address rising healthcare costs overall. Witnesses discussed various models that can deliver greater value at lower prices and addressed persistent barriers to transparency, such as the current lack of upfront pricing. Read Mehlman’s hearing summary here.

Senate Special Aging Committee Chairman Rick Scott, Ranking Member Kirsten Gillibrand Release Investigative Report on Overreliance on Foreign-Made Generic Drugs

On Monday, Chairman Scott (R-FL) and Ranking Member Gillibrand of the U.S. Senate Special Committee on Aging released an investigative report titled “Protecting Seniors’ Access to Essential Medications: Securing the Foreign Generic Pharmaceutical Supply Chain.” The report focuses on the U.S. reliance on foreign-made generic drugs, imported mainly from India and China. Recommendations in the report included creating a federal buyer’s market for essential medicines that prioritizes American-made and allied-sourced products; increasing supply chain transparency; strengthening trade enforcement; closing “Made in America” loopholes; and boosting U.S. biotechnology to ensure reliable access to generic drugs. Read the report here. 

Notable Bills Introduced:

Senators Collins, Shaheen Reintroduce Bipartisan Bill to Lower Prescription Drug Costs

On Monday, Senators Susan Collins (R-ME) and Jeanne Shaheen (D-NH) reintroduced the Ensuring Timely Access to Generics Act to help lower the cost of prescription drugs. The bipartisan legislation would increase competition for generic drugs by providing better oversight of the citizen petition process at the Food and Drug Administration (FDA). Read the press release here and the bill here.

Representative Carter Leads Bipartisan Skin Substitute Access and Payment Reform Act

On Wednesday, Representatives Buddy Carter (R-GA), Marc Veasey (D-TX), Greg Steube (R-FL), and Rich McCormick (R-GA) introduced the Skin Substitute Access and Payment Reform Act, a bill modernizing Medicare’s payment system for skin substitute products, defined as biological materials used to cover and promote the healing of skin wounds. The legislation would set payment limits for all skin substitute products based on historic volume-weighted average prices. Read the press release here and the bill here. 

Executive Branch:

HHS Swears in Alicia Jackson as Director of ARPA-H

On Monday, Alicia Jackson was sworn in as Director of the Advanced Research Projects Agency for Health (ARPA-H). Jackson replaces acting director Jason Roos, who ran the agency after its previous director, Renee Wegrzyn, was removed in February amid the Trump administration's job reductions across health agencies. Jackson has spent the past decade in health technology. Most recently, she founded and worked as the chief executive officer of Evernow, a telehealth company for menopause care. Prior to her career as an entrepreneur, she worked for DARPA, the defense department’s in-house research and development shop, where she was the deputy director of its biology programs office.

Labor Department Releases Guidance for Employers’ IVF Treatment Plans

Late last week, the Department of Labor (DOL) issued new guidance for employers to offer standalone insurance coverage for fertility treatments. The guidance states that Companies can offer infertility coverage, including in vitro fertilization, through an independent benefits package, provided it meets certain conditions. The DOL also stated in a separate statement that it plans to propose regulations to ease limitations on fertility benefits. Read the guidance here and the statement here.