CMS Mailing Restrictions and Their Impact on Oncology Care Delivery

In this interview, David Eagle, MD, Chair of Legislative Affairs and Patient Advocacy, discusses the Centers for Medicare & Medicaid Services (CMS) policy that prohibits community oncology practices from mailing oral cancer therapies or allowing family members to pick them up. He explains that for over a decade practices were permitted to mail medications without issue, until a CMS FAQ at the end of the public health emergency abruptly deemed the practice a Stark violation. The original rationale remains unclear, as the interpretation CMS cited dates back to 2001—years before Medicare Part D even existed—leaving many in the oncology community and members of Congress questioning why a long-standing practice suddenly became prohibited.

Dr. Eagle emphasizes the inequity created by this restriction, as pharmacy benefit managements (PBMs) and hospitals remain free to mail medications while community practices cannot.

Pharmacy Times: Can you explain the CMS policy that bans oncology practices from mailing drugs to patients or allowing family members to pick them up? What was the original rationale behind this rule?

David Eagle, MD, Chair of Legislative Affairs and Patient Advocacy: Well, the exact rationale is still very unclear to many of us in the oncology community, because for well over a decade, we could do it. CMS allowed physicians to mail medications without raising concerns about Stark violations. You know, this issue only came forward in an unusual FAQ issued by the previous CMS administration at the conclusion of the public health emergency.

So, you know, again, that’s one of the most perplexing questions: What was the rationale for this? CMS cited an interpretation dating back to 2001, but that was years before Medicare Part D even existed. And so, you know, that is kind of the heart of the issue. 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.

We’re not the only people with that question. Many of the members of the Energy and Commerce Committee held closed-door sessions with the previous CMS administration. Again, to be clear, this started with the previous CMS administration. Obviously, I wasn’t in the room, and others weren’t in the room, but I think many of us remain confused. That is kind of the core of the question—why something that was acceptable for us to do for many, many years became unacceptable.

And frankly, why can everybody else mail drugs to patients—including the PBMs and the hospitals—while only community practices are not allowed to mail drugs to patients?

Pharmacy Times: PBMs are still allowed to mail oral therapies directly to patients. From your perspective, how does this create an uneven playing field between PBMs and community oncology practices?

Eagle: Or, you know, as I mentioned before, every other entity, to my understanding, is able to mail drugs to patients. We’re the only group that’s not allowed to. It just doesn’t make sense to us. In New York State, where I practice, we have the recently passed Pharmacy Benefit Bureau, which specifically mandates in those rules that practices can mail drugs to patients. So, you know, this conflicts with other people’s view of what responsible practices are.

I think at the core of this is that what we do and what PBMs do are just not the same thing. We, as practices, perform medically integrated dispensing in which the medical and pharmacy operations are tightly integrated. Our pharmacists have access to the electronic medical record. They can message the physicians directly. They never dispense more than a 30-day supply of drugs, because we know patients often have to have drugs held or changed. Dispensing more than 30 days of expensive drugs could be very, very wasteful.

So, you know, the way I think about PBMs in some ways is that they are insurance companies that just happen to own pharmacies. They’re really not oriented to take care of people the way physician practices are and the way integrated pharmacy teams are. In fact, if you look, a lot of states have anti-steering laws to stop PBMs from forcing prescriptions to their own network of pharmacies. And yet, this current CMS policy forces that steerage to the PBMs as part of the Medicare program.

Pharmacy Times: How does this restriction affect patient access to care overall?

Eagle: You know, I mean, I think it goes without saying—being a cancer patient and obtaining cancer care is always hard. I think this policy just makes it even harder. The restriction is that only the patient can pick up the medications. Family members can’t even pick them up. It has to be the patient. And it’s just not always the case that the date of the visit and the date of the pharmacy refill are exactly the same.

So, you know, 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. I think it’s just taking an already difficult situation—being a cancer patient—and making it even harder.