NBDF Government Relations Update - September 2024

Oct 1, 2024

NBDF Launches "Voices for Policy Change" Video Series!

Voices for Policy Change is a resource designed to educate, empower, and mobilize on important legislative issues related to bleeding disorders advocacy, providing a one-stop destination for learning and action. View dozens of videos from community members, advocates and HTC providers on advocacy initiatives such as copay accumulators, HTC's, and advocacy tips to utilize at your next hill day or legislative meeting! All resources including videos, FAQ's, social media toolkits and PSA's can be found on the Voices for Policy Change NBDF webpage.

Federal 

Congress Passes Short-Term Funding Bill: On September 25, Congress passed a short-term funding bill (also known as a continuing resolution or CR) just before the September 30th deadline. The bill will fund the government at current funding levels with a few exceptions through December 20th. Congress will need to act again by the new December 20th deadline to avert a government shutdown. This will also likely be the vehicle for any other end-of-year policy changes.

NBDF-Supported Legislation Advances: With only a few months to go, the 118th Congress is working to move some legislation across the finish line, including bills that NBDF supports:

The Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act (H.R. 3884) passed the U.S. House of Representatives on September 23. The same version of the bill still needs to pass the Senate and be signed into law by the President. The legislation reauthorizes the Health Resources and Services Administration’s (HRSA) Sickle Cell Disease Treatment Demonstration Program from 2024 through 2028.

The Creating Hope Reauthorization Act (H.R. 7384), which reauthorizes the FDA’s priority review voucher (PRV) program for pediatric rare disease drugs, passed out of the House Energy & Commerce Committee. This is an important step forward.

NBDF supports both bills and will provide updates as they advance further in the legislative process.

Administration Files for SCOTUS Review of Braidwood Decision: On Sept. 19, the Biden Administration asked the US Supreme Court to take up the case of Braidwood Management v. Becerra. Plaintiffs in that lawsuit object to provisions of the Affordable Care Act (ACA) that require health plans to cover various preventive services with no patient cost-sharing. Lower federal courts ruled in favor of the plaintiffs, partially striking down the ACA preventive services mandate, but said that ruling only applied to the six named plaintiffs. As a result, the preventive services benefit currently remains in place for everyone else, i.e., virtually all Americans. The Biden Administration is asking the Supreme Court to overturn the lower court rulings, arguing that the lower courts’ decision threatens to disrupt a key part of the ACA that protects patients and saves lives. NBDF has long fought to maintain the patient protections put in place by the ACA, including the preventive services requirement.

NBDF Comments on FDA Guidance on Diversity Action Plans: NBDF recently submitted comments in response to U.S. Food and Drug Administration (FDA) draft guidance, Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. This is a result of legislation passed by Congress in 2022 which required the FDA to issue guidance related to diversity action plans in an effort to improve diversity in clinical trials. The FDA is now requiring diversity action plans for certain clinical trials to increase clinical study enrollment of participants of historically underrepresented populations to help improve the data the agency receives about the patients who may potentially use the medical product. NBDF’s letter highlights the health disparities that exist in the bleeding disorders community both among different races and ethnicities as well as gender.

The FTC-PBM battle continues: Two years ago, the Federal Trade Commission launched an investigation into pharmacy benefit managers and their impact on the accessibility and affordability of prescription drugs. Based on that investigation, the FTC issued an interim report in July 2024, finding that PBMs use their dominant market position to distort competition, limit access, and raise health care costs. In September, one of the nation’s largest PBMs filed suit against the FTC, claiming bias and demanding that the agency retract its interim report. At almost the same time, the FTC filed its own lawsuit against the three largest US PBMs, alleging that they use anticompetitive and unfair business practices to artificially inflate the price of insulin, harming patient access. NBDF continues to engage in the ongoing debate over PBM regulation, urging lawmakers to keep patients at the center of reform efforts.

NBDF on Capitol Hill: NBDF participated in a trio of informative meetings on Capitol Hill on September 18th: a Congressional briefing on alternative funding programs, organized by Hope Charities; an open house and exhibit sponsored by the Plasma Protein Therapeutics Association, highlighting the importance of plasma-derived medicines (including products used in the treatment of blood and bleeding disorders); and a Congressional briefing organized by FAIR Time for Women Coalition, raising awareness about the impact of bleeding disorders on women, girls, and people with the potential to menstruate.

HR 830: Rep. Ritchie Torres (D-NY) and Rep. Roger Williams (R-TX) joined the cosponsor list for the HELP Copays Act this month bringing the total number of House cosponsors to 141.

Drug Affordability Survey: NBDF is a member of the Ensuring Access through Collaborative Health (EACH) Coalition, made up of national patient advocacy organizations addressing the potential impact of state Prescription Drug Affordability Boards on patient access to prescription drugs. NBDF and the EACH Coalition are seeking patient input on the cost of their drugs, rare disease implications, and access challenges. EACH has developed a confidential, patient-designed survey here to collect patient experiences and help ensure the patient voice is included in PDAB policy discussions.

State 

Colorado: NBDF joined the Chronic Care Collaborative of Colorado and other patient advocacy groups on comments to the Colorado Prescription Drug Affordability Board regarding the Board’s draft policies.

Oregon: NBDF signed a letter with other patient advocacy organizations urging the state legislature to require PBMs to share their negotiated rebates and discounts with patients.

Nevada: NBDF presented an update on state copay accumulator adjuster policy legislation to the Nevada Chronic Care Collaborative in Las Vegas Sept. 18.

Prescription Drug Affordability Boards: NBDF participated in a Sept. 27 meeting organized by the Community Access National Network in Washington, DC to discuss and strategize policy solutions to the increasing number of state prescription drug affordability boards and legislation to create them and authorize them to establish upper payment limits for drugs.