House unanimously passes a bill allowing Stark law mail delivery waiver

The U.S. House Sept. 23 has unanimously passed a bill allowing mail delivery of prescription drugs to Medicare patients.

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If fully enacted, the Seniors’ Access to Critical Medications Act of 2024 would amend CMS’ recent reinterpretation of the Stark law, which currently prohibits practices from delivering medications by mail or other services to Medicare beneficiaries.

The bill, introduced Sept. 18, has now moved to the Senate, where it has been referred to the Committee on Finance.

This legislative action follows the dismissal of a challenge by an oncology trade association to the Stark law guidance. On Aug. 30, a district court rejected the association’s objections to the rule that prohibits physicians from dispensing medications outside of their office locations.

The Community Oncology Alliance, a non-profit advocacy group, contested CMS’s set of “Frequently Asked Questions” clarifying that the Stark law’s location requirements “would not be satisfied if a patient receives an item by mail outside the physician’s office.”

The U.S. District Court for the District of Columbia found that HHS’ interpretation of the Stark law exception, which allows self-referrals for in-office ancillary services, was correct.

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