Stakeholder Perspective: The Impact of Oral Chemotherapy Access Legislation

An Interview with Mary Kruczynski
Director of Policy Analysis, Community Oncology Alliance, Washington, DC

In today’s competitive and challenging oncology practice environment, savvy practice administrators keep abreast of health policy issues that may impact their practice’s ability to care for patients. The affordability of oncology drugs remains a concern for many patients with cancer. Out-of-pocket costs for chemotherapy and other oncology-related medications average $4800 annually compared with $450 for medications for other medical conditions1In an effort to help mitigate the cost of cancer treatment for patients, approximately two thirds of state legislatures in the United States have passed oral chemotherapy access legislation, which limits the maximum copayments that can be charged for oral drugs to the same levels that are charged for intravenous (IV) chemotherapy drugs.

To explore the impact of oral chemotherapy access legislation,Innovations in Oncology Management™ conducted an interview with Mary Kruczynski, who currently serves as the Director of Policy Analysis for the Community Oncology Alliance (COA), where she reviews and comments on significant federally proposed legislation, as well as oncology-related issues raised at the state level. Ms Kruczynski has been with COA since its inception and shares her knowledge with cancer care delivery teams across the United States on legislative matters, healthcare reform law, coordinated patient care models, and oral oncology drugs.

Q: How would you describe the issue of oral chemotherapy access, or oral parity, as it is often referred to? Why is legislation needed to address the issue?

Mary Kruczynski:Equal access to cancer drugs is an issue of fairness and patient protection. Patients don’t know how much drugs will cost them until the drugs are prescribed. Depending on their insurance benefit design, most patients are unaware that their out-of-pocket costs for oral medications, which are usually covered under their insurer’s pharmacy benefit, can far exceed what they would pay for IV drugs, which are typically covered under the medical benefit. As more and more oral chemotherapy drugs become available, the patient burden would only become greater in the absence of this legislation.

Q: A total of 34 state legislatures have enacted legislation, many in the past 12 months. When legislation first takes effect, what is the awareness at the practice level?

MK: Oncology practices are very busy, and their primary focus is caring for their patients. Most of the time, they are unaware of newly enacted legislation and rely on others to inform them of recent policy developments.

Q: How are oncology practices and patients made aware of the legislation?

MK: There are a number of advocacy groups that help to disseminate the information. In keeping with our mission, COA is active in explaining the legislation to community-based practices. We send out notices to our membership and have frequent conference calls with our broad network of oncology practice administrators where we keep them aware of important developments in the policy arena.

We also engage clinical and administrative stakeholders through state oncology societies. We educate our members about the details of their state law and explain what to do if insurers are not complying with the legislation.

Q: In states that have enacted oral chemotherapy access legislation, what have been the effects on practices and patients?

MK: Clearly, the laws have had a positive effect on privately insured patients, because they often lower patients’ out-of-pocket expenses for oral chemotherapy medications. Of course, the legislation has also been beneficial to oncology practices, because oncologists can prescribe treatment based on clinical value rather than cost. As a result, practices and patients are no longer put in the position to choose between a more expensive treatment that may be a better therapeutic option and a less expensive, older treatment that may not work as well or may have more side effects.

Q: Are you aware of any unintended consequences of the legislation?

MK: When the first few states passed legislation in 2008 and 2009, some insurers raised IV copays to match oral copays. Since then, the laws have been amended to eliminate this loophole and newer legislation does not allow this practice. There were concerns that the laws might result in increased rates for all commercially insured members, but, so far, there hasn’t been any evidence that premiums have increased in states that have enacted oral chemotherapy access legislation.

Q: What is the status of the oral chemotherapy access legislation that has been proposed at the federal level? Why is it important?

MK: Bills have been proposed in both the House and the Senate, but right now it does not appear that further action is imminent. A national oral chemotherapy access law is impor­tant, because it would offer protection to all insured patients, including those with Medicare coverage who comprise a large proportion of patients with cancer. Right now, the state laws only apply to privately insured patients. In addition, the state laws have different languages and requirements. If a federal law were passed, it would apply equally to everyone.

Q: What do you foresee in the future?

MK: Ultimately, I believe that federal legislation will be enacted, but likely as part of a broader package rather than as a stand-alone bill. When we look at the bigger picture, providing equal access to oral and IV chemotherapy aligns with the goals of integrated value-based care delivery, which is epitomized by the oncology patient-centered medical home. The oncology medical homes emphasize a team-based, patient-focused approach to delivering quality cancer care that is coordinated and efficient. Oral chemotherapy access legislation promotes quality by enabling oncology practices to prescribe the most clinically appropriate chemotherapeutic agents, with the goal of striving for the best possible outcomes for the patient. In my view, it is an important component of the larger effort to deliver quality, coordinated cancer care with the central focus on the patient and his or her entire medical condition.


  1. Fromer M. IOM workshop explores growing problems in patient access to cancer drugs.ASCO Post2014;5.

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