oncology

Oncology Practices Face Disparate Drug Delivery Rules, Raising Access Concerns

A recent and unexpected interpretation by the Centers for Medicare & Medicaid Services (CMS) is creating notable challenges for community oncology practices, restricting their ability to mail medications directly to patients – a practice permitted for other entities like Pharmacy benefit Managers (PBMs) and hospitals.The issue surfaced with an unusual FAQ released by the previous CMS governance following the conclusion of the public health emergency, sparking confusion and concern among healthcare providers and lawmakers.

The core of the dispute centers around a potential Stark Law violation, despite the practice of mailing drugs having been commonplace for years. CMS justified the new interpretation by citing a 2001 guidance, predating the establishment of Medicare part D. This rationale has been met with skepticism, leaving many questioning why a previously acceptable practice is now prohibited. Members of the Energy and commerce Committee reportedly held closed-door meetings with the prior CMS administration seeking clarification, but the reasoning remains unclear.

“What was the rationale for this?” asked Dr. Eagle, a practicing oncologist in New York State. “We’re just not actually sure of CMS’s exact rationale for why something we could do for many, many years all of a sudden became a Stark violation.”

The discrepancy in rules creates an uneven playing field, allowing PBMs to continue mailing oral therapies directly to patients while community oncology practices are barred from doing so. New York State, such as, recently passed regulations through its pharmacy Benefit Bureau mandating that practices can mail drugs to patients, directly conflicting with the federal CMS policy.

Dr. Eagle emphasizes a essential difference between how oncology practices and PBMs operate. Community practices engage in medically integrated dispensing, where pharmacy operations are closely linked to medical care. Pharmacists have direct access to patient medical records and can communicate directly with physicians, enabling tailored medication management. Practices typically dispense only 30-day supplies, minimizing potential waste given the frequent need for dosage adjustments in cancer treatment.

“We, as practices, perform medically integrated dispensing… Our pharmacists have access to the electronic medical record. They can message the physicians directly,” Dr. Eagle explained. “They never dispense more than a 30-day supply of drugs,because we know patients often have to have drugs held or changed.”

In contrast, Dr. Eagle views PBMs as essentially insurance companies with pharmacy ownership, prioritizing financial interests over patient-centered care. Many states have enacted anti-steering laws to prevent PBMs from directing prescriptions to their own pharmacies, yet the current CMS policy effectively steers patients towards PBM-affiliated pharmacies within the Medicare program.

The restriction on mailing medications directly impacts patient access to care, particularly for vulnerable populations. The CMS rule requires patients themselves to pick up their prescriptions, even if they are elderly, immunocompromised, or too ill to travel. This adds another layer of difficulty to an already challenging experience.

“Being a cancer patient and obtaining cancer care is always hard,” Dr. Eagle stated. “This policy just makes it even harder… many of our cancer patients are elderly. They have compromised immune systems. They’re too ill to travel, and now they have to face the added burdens of arranging trips and relying on others.”