Stark Law Interpretation Disrupts Oral Cancer Medication Access
As the public health emergency (PHE) for COVID-19 came to an end in May 2023, oncology practices are grappling with the fallout of regulatory changes. The end of the PHE also marked the end of a waiver that allowed for flexible medication delivery options, a critical service for older, rural, or sick patients. This change has caused significant disruptions in how patients receive their oral cancer medications, and healthcare professionals are raising concerns.
HCN Medical Memo
The current interpretation of the Stark Law poses a significant barrier to patient care. The end of the waiver has disrupted established systems that ensured patients received their medications in a manner tailored to their needs. As professionals committed to patient well-being, it’s crucial to advocate for a legislative fix and explore alternative solutions to ensure uninterrupted access to essential medications.
- Darrell Willyard, PharmD, and other healthcare professionals have developed personalized medication delivery arrangements for patients who are older or live in rural areas.
- The end of the COVID-19 PHE resulted in the termination of a waiver that allowed these personalized arrangements, causing distress among patients and healthcare providers.
- The Centers for Medicare and Medicaid Services (CMS) FAQ document from September 2021 suggests that mailing oral drugs could violate the Stark Law, leading to the current situation.
- Various oncologists and organizations, including the Community Oncology Alliance (COA), are pushing for a legislative fix, but no solution is in sight.
An analysis found $8.9 million in waste of cancer drugs dispensed by mail-order pharmacies compared with $2.4 million in waste from integrated pharmacies.
- Some clinics are trying to become value-based enterprises to obtain a waiver, but not all meet the CMS requirements.
- COA has filed a lawsuit against the US Department of Health and Human Services and lobbied Congress for a legislative fix.
- Integrated pharmacies within oncology practices have shown to be more effective in patient medication adherence and cost-saving compared to mail-order pharmacies.
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