Who can best manage patients with cancer who are receiving oral regimens? The prescribing physician? The prescribing physician with an in-house dispensing system? A specialty pharmacy, or a pharmacy benefits manager that is contracted by a health plan or a self-funded employer?
This debate is not new and it resurfaces periodically in the form of a discussion on “brown bagging,” where drugs are delivered by a specialty pharmacy to patients for self-administration or are transported to their physician’s office for administration; or a discussion of “white bagging,” where a physician submits an order directly to a specialty pharmacy, and the drug is shipped to the physician for administration.
Thoughtful reviews of the process of brown bagging have often led to general concerns regarding this alternative. The risks for patient nonadherence because of split doses, inconsistent adherence, overshipping, mistakes in drug handling related to temperature and stability are significant.
White bagging is sometimes considered an alternative to the oncologist buying the drugs and only submitting a bill to the insurer once the treatment has been administered to the patient (known as the buy-and-bill model). In the managed care environment, however, the term “white bagging” is not often used; rather the process is described as a transition of specialty medications from the medical benefit to the pharmacy benefit.
The goal of such transitions is to implement more effective management tools, such as formularies, utilization management, rebates and discounts for specific drugs, external guidance on the medical appropriateness of a treatment, and the utilization of preferred or exclusive networks under the pharmacy benefit, all of which are expected to yield double-digit savings over the buy-and-bill medical benefit model.
In recent years, Blue Cross Blue Shield of Massachusetts has repeatedly tried to transition oral and office-administered drugs to the pharmacy benefit, but the oncology community mobilized each time to show how much more costly such a move would be, particularly for drugs that have been shipped and paid for but have not been used, because of changes to a patient’s health status, and the unwillingness of the medical community to assume the risk for an untimely and a possibly mishandled drug.
CVS/Caremark has recently decided to narrow the delivery networks for Medicare Advantage Part D drugs to include specialty pharmacies only, not recognizing physician practices as delivery networks. CVS/Caremark justifies this decision based, in part, on its interpretation of the language that the Centers for Medicare & Medicaid Services (CMS) used to define the Medicare Part D program. The program was created when Congress passed the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) in 2003, which allowed covering outpatient prescription drugs under the Medicare Part D benefit.
It took CVS/Caremark 13 years to read the MMA and conclude that CMS intended specialty pharmacies to be the only pharmacy networks allowed to distribute Part D drugs, not regarding the word “pharmacy” in “pharmacy networks” to represent an entity that is allowed to dispense pharmacy drugs under its scope of practice, which could include a pharmacy, a physician office, or a cancer center. This is not a universal interpretation of the MMA, and CVS/Caremark is the only medical entity to have reached this conclusion and call for a change in practice as of January 2017.
Several legal, ethical, operational, financial, and commonsense objections to this limited policy change that is separating the patient from the treating physician in a complex disease such as cancer. At a minimum, this appears to be a clear positioning by CVS/Caremark to grab the market share in the attractive oncology market, and to edge physicians (who can dispense oral drugs and can best manage their patients’ complicated treatment) out of the way, at least for their patients.
Patients are clinically and financially affected by such separations. This is an intrusive force (and staff) that confuses patients with directions and possible calls and outreach, and Medicare Advantage beneficiaries also have to pay different (often significantly higher) copayments and coinsurance under the pharmacy benefit, without support from a supplemental insurance for which they are eligible under traditional Medicare.
The power of an Excel spreadsheet and a collective voice may be able to turn this tide. In addition to the many legal and policy battles gearing up during the summer against this absurdly late (13 years late) interpretation of the MMA, individual practices can contribute a valuable perspective.
Every month I hear stories of how patients are adversely affected and even harmed by a payer or a pharmacy benefit manager and by the mandated delivery of cancer drugs. It is time to track these anecdotes and to make them a part of an ongoing record. I will provide a standardized Excel template for tracking these stories, which can be requested via my e-mail at
Please populate these Excel spreadsheets with your own stories, good and bad. You may mask the patient’s personal information for privacy, but as you amass stories, please share these Excel sheets with me for compilation into an article to be shared in the managed care market and in oncology. This may help to stem the rising tide of similar initiatives by other specialty pharmacy vendors. We need to speak up for our patients. Reinterpreting the MMA in this manner 13 years after the fact makes no sense.