House Unanimously Passes Seniors’ Access to Critical Medications Act

The House of Representatives unanimously passed the Seniors’ Access to Critical Medications Act (HR 5526) on Monday, moving the bipartisan bill onto the Senate.¹

If fully passed, it would amend CMS’ recent reinterpretation of the Medicare Physician Self-Referral Law, commonly known as the Stark Law, to prohibit oncology practices from delivering medications by mail or other services to Medicare beneficiaries. Therefore, this legislation would ensure that patients with cancer and other serious illnesses have timely, reliable access to their medications.²

The bill was introduced on September 18, 2023, by representatives Diana Harshbarger (R, Tennessee) and Debbie Wasserman Schultz (D, Florida), with cosponsors Chuck Fleischmann (R, Tennessee), Donald Davis (D, North Carolina), Troy Balderson (R, Ohio), and Mariannette Miller-Meeks (R, Iowa).³

Originally, the Stark Law was passed in 1989 to prevent fraud and abuse by prohibiting physicians from referring Medicare or Medicaid beneficiaries to receive services from entities they may have a financial relationship with.⁴ However, its stance on mail-order dispensing through medically integrated dispensaries (MIDs) was ambiguous; MIDs are dispensing pharmacies embedded in an oncology center.

In 2021, CMS reinterpreted the law within a frequently asked questions (FAQ) document, claiming that independent community oncology practices delivering oral drugs through courier or mail would violate the federal prohibition on self-referral.⁵ This rule was temporarily waived during the COVID-19 pandemic but expired on May 11, 2023, halting medication delivery. The next day, CMS issued additional guidelines preventing pharmacies from delivering medications to patients personally or by mail; the latest regulation requires that medications be given to patients only when they are physically present at the medical office.

“This ruling has a detrimental impact on many patients with cancer, hindering the equitable delivery of vital cancer medications and increasing health care disparities in rural and underserved communities,” the authors of a commentary published in The American Journal of Managed Care^® wrote.⁵

In response, the Community Oncology Alliance (COA) filed a lawsuit against HHS on July 27, 2023, to overturn this policy change, calling it “an unconstitutional and dangerous display of government overreach that presents real and irreparable injury to patients.”⁶ The group claimed that CMS violated the 10th Amendment to the US Constitution and the federal rulemaking process.

COA applauded the House for unanimously advancing the Seniors’ Access to Critical Medications Act to the Senate.² In a recent press release, Ted Okon, MBA, executive director of COA, expressed the group’s gratitude toward the House, especially representatives Harshbarger and Wasserman Schultz, who were continuously committed to the issue after introducing the bill last year.

Looking ahead, he noted that the Senate must continue this momentum by advancing the companion bill, S 3458. If fully passed, Okon explained that the Seniors’ Access to Critical Medications Act would reduce patient burden by ensuring that all those with cancer or other serious diseases have timely access to their oral medications, whether they be delivered, couriered, or picked up by a caregiver or family member.

“It is crucial that Congress acts to pass this important legislation by the end of this year so all patients can access the medications they need,” he concluded. “COA has led the charge, and the cancer community has been tirelessly voicing concerns with members of Congress and staff to secure this victory for patients.”

References

1. Chair Rodgers applauds House passage of nine health bills. Energy & Commerce. September 23, 2024. Accessed September 25, 2024. https://republicans-energycommerce.house.gov/posts/chair-rodgers-applauds-house-passage-of-nine-health-bills
2. Community Oncology Alliance Applauds US House of Representatives for Passing HR 5526. COA. September 24, 2024. Accessed September 25, 2024. https://mycoa.communityoncology.org/news-updates/press-releases/coa-applauds-house-of-reps-for-passing-hr-5526
3. AJMC Staff. COA supports bills to ensure access to cancer medications. AJMC^®. September 20, 2023. Accessed September 25, 2024. https://www.ajmc.com/view/coa-supports-bills-to-ensure-access-to-cancer-medications
4. Bonavitacola J. Stark Law interpretation disallows medication delivery from independent physician practices. AJMC. February 2, 2024. Accessed September 25, 2024. https://www.ajmc.com/view/stark-law-interpretation-disallows-medication-delivery-from-independent-physician-practices
5. Kumar P, Parker S, Wilbern D. Access denied: CMS' action hurts patients with cancer in rural America. Am J Manag Care. 2024;30(5):206-208. doi:10.37765/ajmc.2024.89537
6. COA files lawsuit against HHS FAQ limiting cancer drug delivery to patients. COA. July 27, 2023. Accessed September 25, 2024. https://mycoa.communityoncology.org/news-updates/press-releases/coa-files-lawsuit-against-hhs-faq-limiting-cancer-drug-delivery-to-patients