Advancing Research for Chronic Pain Act of 2026

Ensuring Patient Access to Critical Breakthrough Products Act of 2025(H.R. 5343 and S.1717) - Legislation to create automatic CMS coverage for devices approved via FDA's breakthrough pathway. (CMS rulemaking for Transitional Coverage of Emerging Technologies (TCET) - advocacy for a new, voluntary Transitional Coverage of Emerging Technologies (TCET) pathway that provides national Medicare coverage for Breakthrough-designated technologies, beginning on the date of FDA market authorization.) The Patient Access to Innovative New Technologies Act (PAINT Act) -- proposed legislation that aims to expand access to new medical technologies by improving the Medicare New Technology Add-on Payment (NTAP) program. It would create a single deadline for products in an alternative pathway, ensure breakthrough devices are eligible for conditional approval under NTAP, and prevent disruption in Medicare beneficiaries' access to new treatments. The Advancing Research for Chronic Pain Act (S. 5041), directs the CDC to regularly collect, analyze, and report data on the prevalence, burden, and impact of chronic pain in the US and build a centralized Chronic Pain Information Hub. The Relief of Chronic Pain Act (S. 3064), which would lower cost-sharing and bar step therapy and prior authorization for non-opioid treatments under Medicare Part D. Starting work on the Food and Drug Omnibus Reform Act of 2026 (Public Law 117-328) - advocacy efforts on Medical Device User Fee Amendments (MDUFA) reauthorization, riders, and device shortages. Reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA) (Public Law 109-417) - advocacy on risk mitigation plans and voluntary shortage reporting related to medical device supply chains and advocacy for medical research and to foster a new era of medical innovation and prepare for future pandemics and promote health equity. Support passage of the Radiation Oncology Case Rate (ROCR) Value Based Payment Program Act of 2025 - Senate (S. 1031) & (H.R. 2120). This legislation would increase access to patient care, enhance the quality of cancer treatments, encourage innovation, reduce disparities for rural and underserved patients, and lower patient costs by saving Medicare about $200 million over 10 years. The WISeR Model (Wasteful and Inappropriate Service Reduction Model) - Advocacy efforts on inclusions in CMS' WISeR model, which is aimed at reducing inappropriate care and preventing improper payments under Medicare Part B by refining prior authorization processes for traditional fee-for-service Medicare. Engaged on the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway and efforts to streamline FDA-CMS coordination and Medicare coverage for Breakthrough Devices.

Client expense: $642,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE