Proposed CMS Changes Are the Wrong Way to Save Money and Will Harm Patients and Providers

David T. Rubin, MD, AGAF, is a professor of medicine and section chief of gastroenterology, hepatology, and nutrition at University of Chicago Medicine. He is a fellow of the American Gastroenterological Association (AGA), which represents over 16,000 gastroenterologists worldwide and is dedicated to empowering clinicians and researchers to improve digestive health. He is also chair-elect of the National Scientific Advisory Committee of the Crohn’s and Colitis Foundation, whose mission is to cure Crohn disease and ulcerative colitis, and to improve the quality of life of children and adults affected by these diseases. AGA is a member of the Biologics Prescribers Collaborative (BPC), an organization comprising medical societies whose members regularly prescribe biologic medicines. BPC strives to ensure that sound policies are in place to promote the safest possible development and use of all biologics, including biosimilars, for all patients.
January 28, 2019
As a gastroenterologist and member of the American Gastroenterological Association (AGA) and Crohn’s and Colitis Foundation, I share the widespread concerns about patient access to affordable medicines. So does the Biologics Prescribers Collaborative (BPC), of which AGA is a member. As dedicated and expert physicians who use biologic medicines, including biosimilars, we are trained to choose treatments based on the individual needs and unique clinical situations of our patients. The recent proposed changes by the Centers for Medicare and Medicaid Services (CMS) to Medicare Part B and Part D drug and biologic coverage under the Medicare Advantage (MA) Program are steps in the wrong direction. These changes put patient health at risk, reinforce the bad precedent set by other payers, increase the administrative workloads of physician offices, and have a disruptive effect on the doctor–patient relationship.

We are acutely aware of the escalating costs of medical therapies in the United States and the critical need to control these costs. However, the best way to control such costs is not by limiting access to rational and appropriate use of the most effective treatments, but rather through other strategies that support comparative effectiveness studies, cost-effectiveness evaluations, and the education of physicians and patients about appropriate use of medical treatments. It is also reasonable to take a hard look at pharmaceutical company pricing, and pharmacy benefit manager rebate strategies and profits, which undoubtedly drive some of the spiraling costs and these strategies. 

Instead of these approaches to saving money, CMS has proposed changes that take a page out of private payers’ books and aim to lower drug costs by applying step therapy for physician-administered and other Part B and Part D drugs.

Step therapy requires a patient to try, and then to fail, 1 or more less expensive alternative therapies before gaining access to the physician-recommended treatment. Step therapy approaches are too often based on outdated evidence (or no evidence) and, as a utilization management tool, they thwart evolved best medical practice. Forcing patients to try cheaper, less-effective therapies and to “fail first” can delay access, by months or years, to more appropriate therapies recommended by physicians. Forcing patients to be on less effective options results in disease persistence, progression, or irreversible damage, which lead to higher long-term medical costs as complications or disabilities worsen.

Some of these costs could be incurred as time spent in emergency rooms, hospitals, rehabilitation facilities, and surgical suites, demonstrably the most expensive places for medical care. They can also result in a higher rate of adverse events. For example, it has been established that patients older than 65 have a significantly increased risk of mortality and adverse events when treated with anti–tumor necrosis factor therapy.1,2 Requiring such Medicare-age patients to be on 1 and sometimes 2 drugs in this class before being able to get one of our newer and safer therapies is harmful and ill-advised. Yet, this is exactly how step therapy is being utilized.

In addition, from a practice administration point of view, step therapy introduces inefficiency and increases regulatory burden on physicians and their office staff.3 Although CMS-allowed step therapy can only be applied to new prescriptions and administrations of Part B and Part D drugs, the interpretation of “new prescription” could come into question, especially for biologics administered at irregular intervals; patients who change MA plans could potentially be required to stop their current treatment and go back to therapies they previously failed just to meet step therapy requirements. With protein-based biologic medications, there is a risk inherent in interrupting therapy because gaps in treatment delivery could promote development of anti-drug antibodies that neutralize the therapy and render it ineffective. Thus, step therapy–imposed delays and interruptions could have severe impacts on patient outcomes.

Additionally, the time required to prescribe 1 therapy and then change to others as forced by step therapy rules increases office overhead, and when patients fail other therapies, the complications of such failure take more time from the office staff to manage such problems.

If the primary aim of the CMS proposal is to lower prescription drug costs to patients, there is scant evidence that savings from implementing step therapy are passed on to beneficiaries. Moreover, evidence suggests that Medicare Part B access costs are not driving up health care costs. No meaningful correlation between drug payment and utilization has been recently supported, suggesting that physicians are not motivated to prescribe drugs with high add-on payments.

Finally, the proposed changes come between doctors and their patients, and are counter to the critical doctor–patient relationship that is based on trust and focused on comfort and care. The very concept of “fail first” means a patient must suffer before they can receive the therapy that their physician recommended. Such a policy inserts the third-party payer (in this case CMS) between the physician and patient, and is disruptive and destructive to this fundamental tenet of medicine.

The AGA, the Crohn’s and Colitis Foundation, and the BPC recognize and appreciate the critical importance of having access to appropriate healthcare options that are also affordable for society’s needs. We urge CMS to limit the use of utilization management tools such as step therapy in the Medicare program and instead to set policies and encourage novel initiatives to use resources efficiently, to improve healthcare outcomes, and to preserve the valued doctor-patient relationship.   

1. Lobatón T, Ferrante M, Rutgeerts P, Ballet V, Van Assche G, Vermeire S. Efficacy and safety of anti-TNF therapy in elderly patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2015;42(4): 441-51. doi: 10.1111/apt.13294.

2. Cottone M, Kohn A, Daperno M, et al. Advanced age is an independent risk factor for severe infections and mortality in patients given anti-tumor necrosis factor therapy for inflammatory bowel disease. Clin Gastroenterol Hepatol. 2011;9(1): 30-5. doi: 10.1016/j.cgh.2010.09.026.

3. Rubin DT, Feld LD, Morgan I. Communication with US payers regarding inflammatory bowel disease medications are a substantial burden on healthcare provider resources and can result in compromised patient care: results of a US provider survey. Presented at Digestive Disease Week 2016; May 21-24, 2016; San Diego, California. Abstract Sa1114.


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