Have we lost the concept of common sense in our aggressive pursuit of “value” in healthcare? Variations regarding what constitutes actual value have led to wide gaps in physician, hospital, payer, pharmacist, and patient perspectives, and that is before factoring in the opinions of various “middlemen,” including pharmacy benefit managers (PBMs), laboratory benefit managers, and medical benefit managers. Patients are falling through these gaps and are being harmed. It is time to pull back and reconnect with rational discussions on the benefit, harm, and risk of payer policy and coverage decisions regarding medical care.
When did the definition of “medical necessity” become variable? When did it become socially acceptable to challenge every treatment decision that physicians make regarding their patients with cancer? Some suggest it happened when the costs of therapy began rising with new scientific discoveries. I have become more cynical over time and attribute it to the middlemen who started making their living by taking a percentage of the perceived savings they were able to claim. But, are those real savings, and at what cost?
When new drugs or technologies come to market, there is always a reason—competition, scientific breakthrough, or other innovations. The medical community learns about these new treatments through peer-reviewed publications or presentations at national meetings, such as the American Society of Clinical Oncology Annual Meeting 2022, held this June in Chicago, IL, where medical professionals from across the country discussed new care options.
The National Comprehensive Cancer Network (NCCN®) brings together hundreds of physicians to discuss updates to the NCCN Clinical Practice Guidelines in Oncology®. Most payer coverage policies seem to consider these guidelines as a starting point for formulary and coverage, but then through internal processes, or upon the recommendation of middlemen vendors, they narrow the scope or change the specific terms of coverage as it relates to individual drugs, or they create hurdles blocking the use of new technologies.
I realize there may be valid reasons for these decisions. Clinical trials seek to enroll patients with specific attributes, so the application and experience of a new treatment in the general patient population may vary. Because the costs related to cancer treatments are generally very high, an employer or insurer may be worried about medical expenses exceeding their projections.
However, there can be other reasons for these decisions, which result in inadvertent negative consequences for patients and providers. These additional reasons, many of which may involve middlemen inserted between payers and providers, may include perverse incentives for formulary restrictions based more on the price of a drug than the impact of losing access to that drug, opportunities for rebates, opportunities to shift drug dispensing to an owned or affiliated pharmacy, or revenue sharing for reductions by any means in medical cost. Employers, insurers, and middlemen do not provide medical care, and decisions regarding coverage and payment that are driven by entities outside of the direct medical care delivery process and that adversely affect patients become suspect and should be appropriately challenged.
Policies That Do Not PASS the Commonsense Test
Recent examples of policies that do not pass the commonsense test include white bagging, payer-driven dose reduction, and requiring patients to fail multiple older generic drugs before being allowed to try newer medications, which was the case with intravenous iron.
Oncologists know their patient’s condition and medical history. They check their patient’s health status the day of treatment to ensure that he or she can receive the planned therapy. If, as often happens, the scheduled treatment must be adjusted, canceled, or changed to another treatment, oncologists are able to make these adjustments on the fly without incurring additional costs to the patient, insurer, or employer because they make the effort to keep an appropriate inventory of medications in their offices. Treatments are only billed to the patient’s insurer after they are administered. This process, known as “buy and bill,” evolved because of the volatile nature of cancer and the approaches required to treat the disease.
Early attempts by specialty pharmacies and insurers to white bag (ie, ship drugs to physicians’ offices prior to treatment) were usually refused for 2 key reasons. First, because the pedigree and handling of toxic oncology drugs is critical, physicians would not accept the liability of treating patients with drugs arriving from sources (or through methods) that were not vetted by them. Second, because cancer is unpredictable in nature, there was the possibility that drugs shipped to physicians’ offices (or patients’ homes) were no longer needed in that dosage or needed to be switched for a different product. Once drugs are shipped for a specific patient, they cannot be returned or used for another patient. As a result, unused drugs become waste and must be disposed of properly (at signficant expense).
As insurers, PBMs, and specialty pharmacies have tried more recently to force white bagging through coverage policy and reimbursement, a medical practice could potentially accumulate hundreds of thousands of dollars of “shipped but wasted” drugs, which were billed by the PBM or specialty pharmacy, paid for by the patient and the insurer or employer, sent to the physician’s office, and yet never actually used in the treatment of the patient. Fortunately, some states are now passing laws prohibiting these practices. For example, Vermont just passed such a law on May 24, 2022.
In the August 2021 issue of Oncology Practice Management, I discussed a new policy started by Anthem in 14 states, which identified more than 40 oncology drugs distributed in single-dose vials. Under standard-of-care weight-based dosing, appropriate treatment is likely to require more than 1 vial, each of which will be billed to the insurer as complete vials. Since single-dose vials may not be reused for another patient for safety reasons, each full vial is billed whether or not it is needed for the appropriate patient dose.
The Anthem policy stated that providers will be asked to voluntarily reduce the requested dose to the nearest whole vial, if the originally requested dose is within 10% of the nearest whole vial. If physicians decline to do this, they are asked to justify their response before proceeding with the treatment authorization request. Other payers are beginning to copy this policy.
The policy makes no sense from a clinical perspective because it asks physicians to change a patient’s treatment for the purpose of reducing the number of vials paid for by the insurer. This reduced dosing would result in patients receiving less than standard-of-care treatment, driven by an insurer’s cost-savings initiative. Insurers do not treat patients and should not be involved in even advocating for these types of decisions. These choices need to be made solely by physicians based on their knowledge of the patient, free of undue influence.
Step Therapy/Requiring Treatment Failure
In the February 2022 issue of Oncology Practice Management, I discussed the fact that several regional and national payers were implementing a policy requiring patients to fail on multiple older generic drugs associated with lower replacement iron loads and higher toxicities for weeks or months before being allowed to try newer drugs with higher replacement iron loads and better tolerability, which can be administered in just 1 or 2 doses. Physicians and state oncology societies across the country are expressing significant concerns over the negative impact of this policy. Under these restrictions, patients have been unable to get the treatments they need and may be less able to function at work or home, and can have greater difficulty tolerating their chemotherapy.
Where Is the Common Sense?
When distanced middlemen write policies and present only a limited perspective on the impact of such policies to the insurer or employer, patients and physicians are left to struggle with the consequences and the subsequent costs to health, quality of life, and appropriate care. When managed care physicians meet directly with treating oncologists to learn and share the pros and cons of such policies, the result is more likely to be common sense, and a logical, collaborative approach to a policy and its consequences for patients, providers, insurers, and employers can evolve.
It does not make sense that patients and providers have to deal with treatment delays and the expenses incurred by unused oncology medications or that a specialty pharmacy can take over the preparation and distribution of white-bagged drugs in place of the more cost-effective, medically efficient process of buy and bill in the physician office where patients are being treated. No one wants to pay for shelves of drugs that must be destroyed simply because they were shipped outside of the patient–physician treatment paradigm that has worked effectively for decades. Buy and bill is the most efficient way to ensure that only the drugs that can actually be used are administered and billed, which is an extremely important concept in cancer treatment.
It makes no sense to push physicians and patients to accept less than standard-of-care dosing if the patient is unfortunate enough to be insured by a health plan that is espousing single-vial dose reduction. Patient dosing is based on an individual’s weight, not the number of vials limited under a coverage policy. This is a violation of the separation of medical practice and health plan operation.
It also makes no sense to force patients to endure weeks or months of treatment with older, more toxic drugs that cannot, per FDA safety determinations, reach sufficient patient replacement iron loads. The uproar from the medical community is growing and driving direct conversations among medical directors and treating physicians and should soon bring reason to the policy and coverage.
What Can We Do?
As a medical community, we owe it to our patients to speak up against policies that fly in the face of appropriate standards of care and common sense. Our patients rely on us to advocate for them. Do not speak to the provider representatives, go directly to the medical directors of any insurer that advocates for egregious coverage decisions. Individual state oncology societies and the National Oncology State Network are actively engaged in outreach efforts regarding these issues. If you do not know how to approach the right person, please feel free to reach out to me at
Correction: Regarding my editorial in the February 2022 issue of Oncology Practice Management, titled “New Policies Regarding Intravenous Iron Replacement Are Creating Conundrum for Providers and Payers,” I have been asked to share a correction regarding the discussion of intravenous (IV) iron products. Although this was an editorial and not intended to offer prescribing recommendations, I would like to correct any misconceptions that may have arisen from the discussion of coverage policy and step edits for IV iron products.
More than 1 product is FDA approved for adult patients with intolerance or poor response to oral iron or who have chronic kidney disease, and each has different FDA maximum dosages per course of treatment, ranging by dosage and duration of course of treatment (single or double doses vs weeks or months). For example, ferric carboxymaltose was approved in 2013 for 1500 mg dosed over 2 injections 1 week apart. Ferric derisomaltose was approved in 2020 for a single 1000-mg dose. For specific approved dosing and treatment indications, please refer to the relevant FDA-approved package inserts before treatment decision-making.