New federal guidance is hurting cancer patients, especially those in rural areas

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.

This befuddling rule change has led to serious disruptions in the world of community oncology, where the vast majority of Americans receive their cancer care. The new interpretation of Stark reveals a somewhat limited understanding of the evolution in medical therapy and practice over the past decade (today, nearly half of my patients receive oral anti-cancer drugs) and has a disproportionate effect on rural patients.

For example, Tennessee Oncology, where I practice, is the largest provider of rural cancer care in the state. The practice maintains a centralized dispensing pharmacy in Nashville, with a large staff of more than 35 team members who peruse the electronic health records to gain context on patients’ treatment plans, comorbidities, and medication lists, and advise physicians on dosing, drug-drug interactions, or expected toxicities through an integrated electronic health record and text-based messaging system. Such a close working relationship with our pharmacists allows oncologists to share the load of educating and monitoring patients on these drugs, many of which carry toxicities and side effects that are as severe as their infusion counterparts. No longer able to mail or courier drugs directly to their homes, our patients are stuck with one of two choices: switch to a pharmacy-benefit manager-owned mail-order pharmacy, which would not integrate with or communicate with their oncology provider, or rely on picking up their cancer meds in person for every refill. In fact, many states have passed anti-steerage bills in recent years that prohibit PBMs from requiring physicians to route prescriptions to corporate specialty pharmacies, recognizing that such steerage is explicitly profit-, not patient-centric. However, given the scope of state law, these anti-steerage laws typically only apply to fully insured or self-funded non-ERISA plans.

Currently, Tennessee Oncology’s pharmacy has devised a complicated work-around to comply with the Stark regulation by sending daily shipments of drug to the 36 various clinic sites around the state. We attempt to time delivery to sync with patient visits to clinic to minimize disruption as much as possible and allow patients to pick up their medication refills when they visit their physicians. This work-around is operationally complex and not totally foolproof. After all, not every refill aligns with a planned visit to a doctor’s clinic. My patient with metastatic breast cancer flatly refused to travel in twice a month — once to pick up her oral refills, and once to receive her fulvestrant injections — and given the long commute, I don’t blame her. We had to adjust her oral regimen out to a monthly schedule. This is not how the regimen was studied on trial or approved by the FDA, and I have no data to quantify the degree of loss in efficacy with an extra off-week between cycles.

My colleagues across the state and country have reported similar troubling tales. A physician practicing in Chattanooga told me about “a very pleasant 74-year-old that I have been treating for chronic lymphocytic leukemia (CLL) almost 20 years.” Now, instead of having her prescription mailed to her house, “her granddaughter who works the third shift has to drive [her] an hour each way once a month. … This terrible legislation is impacting whole families not just the patient.”

Again and again, my colleagues and I note that the patients most affected by the CMS guidance are older, live in rural areas far from their nearest clinic, and are often dependent on family members for transportation. An analysis performed at Texas Oncology (part of the U.S. Oncology Network) found that nearly a third of all patients lived more than 20 miles from their nearest clinic, and two-thirds of patients living that far ranked highly on an Area Deprivation Index scale, which correlates with socioeconomic disadvantage. CMS’s guidance feels very much at odds with the Biden’s administration’s goal to reduce disparities in health care access and outcomes, particularly in cancer care.

This new interpretation isn’t just hurting patients; it’s also exacerbating waste, driving up health care costs. If a drug shipped out to a satellite clinic isn’t picked up — because of disease progression leading to a regimen change, toxicity leading to a treatment pause, hospitalization, patient death — it is ineligible to be restocked and must be discarded. This is despite the fact that the medication never left custody of the practice, and is unopened, unused, and unexpired. That wouldn’t have happened under the old workflows. The pharmacy team at Tennessee Oncology has calculated that this has led to millions of dollars of drug wastage. As the nation collectively emerges from a year marked by very publicly catastrophic chemo drug shortages, this senseless wastage of perfectly viable, reusable cancer medication is deeply upsetting.

I’ve tried to understand why this change was made, but I simply cannot find the benefit to patients. Yet, despite mounting evidence of negative repercussions, CMS remains insensate to the pleas of community oncologists, leading to lawsuits and proposed legislative amendments. Though 2024 is an election year, which can divert attention to more headline-grabbing issues, my hope is the optimal care of cancer patients remains one that can garner grassroots enthusiasm and bipartisan support.

Samyukta Mullangi, M.D., M.B.A., is a medical oncologist at Tennessee Oncology and is the medical director of oncology for Thyme Care, a cancer population health company.