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New federal guidance is hurting cancer patients


I recently started a patient with metastatic triple-positive breast cancer patient on a targeted therapy regimen consisting of capecitabine and neratinib, both oral chemotherapy pills that are dosed on a 21-day cycle. Given that her cancer also thrives on estrogen, I chose to continue her monthly fulvestrant injections (which targets estrogen) in my clinic in Dickson, Tennessee, a small town 40 minutes outside Nashville.

Until last year, my patient would have been able to make the hour-long drive to my clinic every four weeks for the injection and have our medically integrated specialty pharmacy send her the oral chemotherapeutics every three weeks by courier to her home.

However, as of spring 2023, that is no longer possible. That’s when the Centers for Medicare and Medicaid Services began to enforce guidance that was issued in 2021 (but temporarily suspended in the course of the pandemic) that specialty pharmacies embedded into independent physician practices would be in violation of the Physician Self-Referral Law—commonly known as the Stark Law — if they were to dispense oral medications to a patient’s home by mail or courier, or even if they were to dispense the drugs to a patient surrogate such as a family member.

The Physician Self-Referral Law, originally issued in 1989, is intended to prevent fraud and abuse by prohibiting physicians from referring Medicare or Medicaid patients to a health care entity in which the doctor might have a financial interest. In its guidance, CMS seems to indicate that the actual existence of a medically integrated specialty pharmacy isn’t in violation of Stark. Rather, it’s the shipping or mailing of drugs to patients — in other words, patient-centric activities that, if anything, typically cost the pharmacy in extra postage, and which have no impact on physician prescribing behavior.

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