LUGPA Policy Brief: Seniors' Access to Critical Medications Act

October 2023 

Efficient, high-quality, outcomes-driven healthcare hinges on patient compliance with prescribed care plans. To maximize the benefits of life-extending and lifesaving medications, several key factors must be addressed:

1. Patient Education: Ensuring patients understand the purpose of their medications.
2. Removing Barriers: Eliminating logistical and financial obstacles that impede access to critical medications.
3. Compliance Monitoring: Regular tracking of patient adherence, assessment of side effects and tolerability, and adjustment of dose or therapy when indicated.

Regrettably, policymakers often ignore the importance of monitoring patient compliance and ongoing monitoring and adjustments of therapeutic regimens. This policy brief provides insight into these issues and highlights the critical role of physician practices in promoting patient compliance.

A 2017 CDC study revealed that 20 to 31 percent of prescribed medications are never filled. As a result, nearly 50 percent of patients do not adhere to their treatment plans, with significant long-term adverse healthcare outcomes and associated increases in expenses. Patients can experience short-term and long-term complications when prescriptions remain unfilled, ultimately driving up resource utilization and healthcare expenses.

As a component of integrated care, many physician groups within LUGPA offer pharmaceutical dispensing services to their patients. LUGPA firmly believes that dispensing certain pharmacologic treatments, particularly in the setting of advanced oral oncolytic medications in a physician's practice, enhances patient access, care coordination, and compliance monitoring. In-office dispensing eliminates factors contributing to medication non-adherence, including patient education, unclear or illegible prescriptions, while promoting intensive follow-up. This enables immediate medication adjustments by a provider when necessary, enhancing regimen compliance and therapeutic efficacy.  

Because it is clear that many medical services are intimately linked and the manifest benefits to patients of care delivered in an integrated fashion, Stark Law regulations provide several specific exemptions for certain in-office ancillary services, allowing physician practices to provide critical medical services, including in-office dispensing, radiation therapy, imaging, and pathology.

However, a problematic FAQ issued by CMS in 2021 could potentially limit access to prescription medications for Medicare beneficiaries, with a particularly potentially detrimental impact on a subset of patients suffering from advanced malignancies. This policy brief calls for the retraction of this FAQ to protect access to life-saving treatments and to maintain the autonomy of patients and physicians in determining the optimal way to deliver care.

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.

On September 18, a new bipartisan bill was introduced that addresses many of LUGPA’s concerns—the Seniors’ Access to Critical Medications Act (HR 5526), introduced by Reps. Harshbarger and Wasserman-Shultz. 

The Seniors' Access to Critical Medications Act amends section 1877 of the Social Security Act, clarifying that delivery of medicines through various methods or by allowing a family member or caregiver to pick up medication on behalf of a patient does not violate the Stark Law and does fall within the scope of Stark's IOAS exception. The bill requires CMS to address the FAQ interpretation of current law prohibiting delivering medicines to patients not physically present in the physician's office. It also rescinds two CMS FAQs on this matter.

The bill would be effective for services consisting of drugs or necessary supplies furnished on or after May 11, 2023, coinciding with the expiration of the Stark waiver related to this issue after the COVID-19 public health emergency.

LUGPA remains committed to advocating for patient access to integrated urology care and will continue its efforts to protect the autonomy of patients and physicians in making treatment decisions. For more information on in-office dispensing, you can read LUGPA’s Policy Brief here.