LUGPA Policy Update on H.R. 5526, Seniors’ Access to Critical Medications Act of 2023

June 2024  

Effective healthcare delivery hinges on patient compliance with prescribed medications. Studies indicate significant non-adherence rates, which lead to adverse health outcomes and increased healthcare costs. LUGPA’s advocacy has underscored the role of integrated care and in-office pharmaceutical dispensing in enhancing patient access, coordination, and compliance monitoring. This approach ensures timely adjustments to therapy, thereby improving treatment efficacy and patient outcomes.

Despite these benefits, challenges persist, notably due to CMS policies that could restrict access to vital medications, particularly for Medicare beneficiaries facing advanced malignancies. LUGPA strongly advocates for the retraction of a 2021 CMS FAQ that could undermine in-office dispensing practices critical for patient care. Additionally, LUGPA supports maintaining the In-Office Ancillary Services Exception (IOASE) under Stark Law, ensuring continued access to essential medical services within physician practices.

Legislation Restoring In-Office Dispensing Moves Forward in Congress

In June, the House Energy & Commerce Committee marked up 13 health bills, including H.R. 5526, the Seniors’ Access to Critical Medications Act of 2023. This legislation has progressed favorably, being reported out of the committee with amendments on a unanimous recorded vote of 43-0. It is now slated for consideration on the House Floor this summer. If passed, it is expected to be part of a year-end healthcare package during the lame-duck period following the November elections.

H.R. 5526 aims to authorize Medicare patients to receive medications by mail permanently and allows family members or caregivers to pick up medications on behalf of patients. Notably, it addresses concerns raised by Ranking Member Pallone during earlier markups by incorporating provisions that include a 5-year waiver of the Stark law. This waiver permits physician practices to mail drugs to patients, provided there is an annual in-person visit requirement, and mandates a CMS study on utilization and cost implications across different disease groups.

Advocacy Goals and Collaboration

LUGPA actively engages with policymakers to educate on the benefits of in-office dispensing and the nuanced differences between delivery and dispensing and supporting legislative efforts such as H.R. 5526, which clarifies Stark Law provisions to safeguard in-office pharmaceutical services, crucial for patient-centered care in urology and other specialties.

LUGPA actively advocates for:

• Physicians' ability to continue providing in-office pharmaceutical dispensing where allowed by state statute.
• The retraction of CMS's 2021 FAQ on in-office dispensing.
• Maintaining the current In-Office Ancillary Services Exception (IOASE) within the Stark Laws to allow in-office dispensing.
• Educating policymakers on the distinction between delivery and dispensing and the benefits of in-office dispensing.
• Collaborating with CMS and Congress to ensure that the exception covers LUGPA providers and their ancillary services.

As H.R. 5526 progresses through Congress, LUGPA remains steadfast in its commitment to advocating for policies that enhance patient access to integrated urology care. By safeguarding the autonomy of patients and physicians in treatment decisions and addressing regulatory challenges, LUGPA continues to support initiatives that support comprehensive, patient-focused healthcare delivery.

For more information on in-office dispensing, you can read LUGPA’s Policy Brief here.