House and Senate lawmakers will resume legislative business today as negotiations on a continuing resolution (CR) continue. In particular, discussions at the leadership level are likely to focus on reaching agreements on items that could potentially be added onto the stopgap, including energy permitting reforms and reauthorization of several user fee agreements at the Food and Drug Administration (FDA). Both of these proposals will require bipartisan cooperation to ensure that the CR can pass the Senate with a filibuster-proof majority \u2014 a factor that could prolong the talks into the final days leading up to the September 30 deadline. Meanwhile, members of the House Freedom Caucus have coalesced behind a strategy spearheaded by three GOP senators \u2014 including Sens. Mike Lee (R-UT), Rick Scott (R-FL), and Ted Cruz (R-TX) \u2014 in opposing a CR through mid-December. Instead, the Republican lawmakers have been pushing for a “clean” funding bill that maintains current federal spending levels until the new Congress begins in 2023<\/p>\n\n\n\n\n\n\n\n
Congress Continues Negotiations on User Fees, Sets New Target for Deal\u00a0<\/strong> The Senate Judiciary Subcommittee on Immigration, Citizenship, and Border Safety held a\u202fhearing<\/a>\u202f(TRP summary<\/a>) on Wednesday to discuss the role of immigrants in the health care workforce. While current law allows health care professionals to migrate to the U.S. in order to provide medical services, growing health care workforce challenges have called attention to the limitations that currently exist within the parameters of these policies. Reps. Bera, Bucshon Introduce Bill to Increase Reimbursement Under the Medicare Physician Fee Schedule<\/strong><\/p>\n\n\n\n
Senators are continuing their discussions on a reauthorization package for several\u202fuser\u202ffee agreements at the FDA as leaders hope to tack on a final deal to the forthcoming CR. According to the latest intel, lawmakers are still haggling over a series of policy riders that could potentially be included with the final\u202fuser\u202ffee language. Earlier this year, the House (TRP analysis<\/a>) and the Senate (TRP analysis<\/a>) unveiled their respective pieces of legislation to reauthorize the Prescription Drug User Fee Act, Generic Drug User Fee Amendments, Biosimilar User Fee Act, and the Medical Device User Fee Amendments programs.\u00a0<\/p>\n\n\n\n
The UFAs are reauthorized in five-year increments and represent an agreement between lawmakers, manufacturers, patients, and industry stakeholders to strike a balance between efficient product approval processes and garnering fees to operationalize these goals. The FDA relies on user fees to supplement their appropriated funds, and the looming September 30th expiration of the most current five-year authorization poses operational challenges for the agency. While the House and Senate were expected to work to reconcile differences as committee hearings took place in the early summer months, negotiations were paused as both chambers turned their attention toward the now-passed Inflation Reduction Act. Congress is now down to the wire on UFA reauthorization with just days left before the programs expire.\u00a0<\/p>\n\n\n\n
White House Issues EO, Outlines Spending For New Biotech, Biomanufacturing Initiative<\/strong><\/p>\n\n\n\n
On Monday, the Biden administration issued an executive order\u202f(EO 14081<\/a>)\u202fto establish a new biotechnology and biomanufacturing initiative across multiple sectors of the economy, including within the health care realm.\u202fA key policy goal set forth by the White House seeks to harness biotechnology and biomanufacturing research and development (R&D), particularly through applied biosafety and biosecurity innovation. Additionally, the new initiative places emphasis on: (1) growing domestic biomanufacturing capacity; (2) expanding market opportunities for bio-based products; (3) improving access to federal data; (4) streamlining regulations for biotechnology products; and (5) supporting a diverse biotechnology and biomanufacturing workforce, among other items.\u00a0
In conjunction with the new initiative, the White House held a Summit on Wednesday where various agencies announced details for investments and resources to implement the EO. Notably, the $2 billion funding tranche includes $40 million for the Department of Health and Human Services (HHS) to expand the role of biomanufacturing for active pharmaceutical ingredients, antibiotics, and more.\u00a0\u00a0<\/p>\n\n\n\n
House E&C Advances Bills on Prior Authorization, Vaccine Injury Compensation Program<\/strong><\/p>\n\n\n\n
The House Energy and Commerce Subcommittee on Health held a\u202fmarkup<\/a>\u202f(TRP summary<\/a>) to consider five bills that were ultimately amended and passed through the Subcommittee. Bills pertaining to prior authorization (PA) in Medicare Advantage (MA) plans, providing mobile health care funding, and reauthorizing grants to address trauma care services were all approved on a bipartisan basis. Notably, the Subcommittee\u2019s passage of the MA bill occurred just before the bill\u2019s unanimous passage by the full House. However, disagreements arose regarding a bill that would reauthorize the Flint, Michigan Lead Exposure Registry. Republicans offered a series of amendments that would expand funding for the registry to other communities experiencing similar water resource issues, as well as provisions that would require state and local funding to supplement federal funding. Despite these conflicts, the Republican amendments failed, and the underlying bill was passed \u2014 as amended \u2014 due to the Democrats\u2019 majority.\u00a0<\/p>\n\n\n\n
Senate Judiciary Looks Towards Immigration to Combat the Health Care Workforce Shortage<\/strong><\/p>\n\n\n\n
Throughout the hearing, Republicans and Democrats agreed that the health care workforce shortage has placed a burden on the U.S. health care system, resulting in additional barriers compounded by the COVID-19 pandemic. Democrats called for passage of the HealthCare Workforce Resilience Act (S. 1024<\/a>) and the Conrad State 30 and Physician Access Reauthorization Act (S. 1810<\/a>) in order to address the intricacies of current immigration law that further contribute to these shortages. While there was general agreement among Members that increasing the numbers of immigrant health care professionals could lessen this burden, Republicans on the Subcommittee demanded that broader immigration challenges be addressed prior to the passage of legislation specific to the health care workforce.\u00a0<\/p>\n\n\n\n
Last week, Reps. Ami Bera (D-CA) and Larry Bucshon (R-IN) introduced a bipartisan\u00a0bill<\/a>\u202fthat would provide a 4.42 percent physician fee schedule (PFS) adjustment\u202ffrom January 1, 2023, through January 1, 2024.\u202fThe legislation comes on the heels of the Centers for Medicare and Medicaid Services\u2019 (CMS)\u00a0proposed<\/a>\u00a0calendar year (CY) 2023 PFS rule (TRP analysis<\/a>), which included a decrease to the conversion factor that would reduce physician payments from Medicare by roughly 4.5 percent in 2023. The agency\u2019s proposal drew the ire of provider groups and other stakeholders, who immediately called for CMS to request that Congress intervene and implement a positive adjustment. In addition to the payment adjustment, the legislation also expresses a sense that HHS should, in conjunction with Congress, execute administrative and legislative actions to: (1) promote Medicare physician payment system\u202ffinancial stability and predictability; (2) encourage and reward innovation in value-based care; and (3) advance health equity by ensuring timely access to quality care.\u00a0<\/p>\n\n\n\n