A 2021 interpretation of Stark law prohibits medication delivery from independent physician practices, which is in turn affecting patient care, according to a Jan. 30 report in JCO Oncology Practice written by three oncologists.
Many independent practices are now finding themselves in violation of Stark law because they operate using medically integrated specialty pharmacies to deliver medications to patients by mail or courier.
Before the ruling, some providers felt Stark law was vague about mail-order dispensing by medically integrated dispensaries, according to the report. While public health emergency laws during COVID-19 allowed mail-order dispensing, the new interpretation confused the issue, which pushed many MIDs to stop the practice.
According to the report, this issue has had a huge effect on oncology patient care, as "the majority of oncology practices have, over the past decade, established medically integrated specialty pharmacies to facilitate prescribing and toxicity monitoring."
The interpretation "betrays a somewhat limited understanding of the evolution in medical therapy and practice over the past decade," according to the report, and the ruling disproportionately affects older patients and those in rural areas.
While CMS has said that patients are unlikely to be harmed since they could use the mail-order pharmacies owned or operated by pharmacy benefit managers, the report noted that quality of care is worse because such pharmacies "disrupt the closely coordinated systems that physicians and pharmacists establish to coordinate care for patients.".
The authors support an amendment introduced to the House in October that clarifies the Stark law policy to no longer apply to services consisting of drugs and related administration activities.