The American Society of Clinical Oncology (the Society), an affiliated organization of the Association for Clinical Oncology (the Association), collectively known as ASCO, submitted an amicus curiae brief in support of motions in four cases to enjoin the Most Favored Nation (MFN) Model from taking effect on January 1, 2021. The Society’s friend-of-the-court brief urges the courts to stop implementation of the model, citing its devastating impact on patients.
The brief was filed in the cases (1) Ass’n of Cmty. Cancer Ctrs., et al v. Azar; (2) Biotechnology Innovation Org., et al v. Azar; (3) Regeneron Pharm. Inc. v. U.S. Dep’t of Health & Human Servs; and (4) Community Oncology Alliance, Inc. v. U.S. Dep’t of Health & Human Servs, where the plaintiffs assert that MFN exceeds the Centers for Medicare & Medicaid Services’ (CMS) statutory authority and that CMS failed to follow required rulemaking procedures that would have identified many of its flaws.
The analysis reflected in the amicus brief shows dire consequences for people with cancer under the MFN Model. CMS projects that the model will cause 19% of beneficiaries to lose access to its 50 targeted drugs, 38 of which are used in cancer treatment. ASCO’s own analysis of MFN finds that, among other detrimental effects, it would drastically cut reimbursement for four immune checkpoint inhibitors commonly used to treat advanced and metastatic lung and other cancers, and that as many as 87,556 years of life would be lost by patients with lung cancer due to the loss of access to these four drugs alone over the model’s seven-year duration.
ASCO’s analysis also shows the potential for MFN to cause irreparable harm to oncology practices which will directly threaten access to care for Americans in many communities. ASCO estimates that independent community oncology practices will see a 52% average loss of Medicare drug revenue once the model is fully phased in and that hospital outpatient oncology departments will see an average loss of 50% by year four of the model.
Community oncology practices rely on drug reimbursement—at a rate of a drug’s average domestic sales price, plus a 6% add-on fee—to cover much more than the costs of acquiring drugs. Drug reimbursement is also used to cover the many practice expenses for which Medicare does not specifically provide reimbursement, such as operating the practice pharmacies that enable handling of hazardous chemotherapy drugs, compensating for drugs that cost more to acquire than their average sales price, and providing counseling to people with cancer during this difficult time in their lives. MFN will render many oncology practices unable to afford to offer these essential services.
“Because of the harm to patients, ASCO must strongly oppose the MFN model,” said Monica M. Bertagnolli, MD, FACS, FASCO, Board Chair of the Association of Clinical Oncology. “This model, which imposes a nationwide, mandatory experiment without the ability to actually learn whether this is an optimal approach, will drastically cut reimbursement for a number of life-saving cancer drug treatments, significantly limiting access to care for Medicare beneficiaries. Implementing such a model during the COVID-19 pandemic will also further strain oncologists’ ability to provide high-quality, equitable cancer care.”
In addition to the amicus brief, the Association submitted comments to CMS Administrator Seema Verma outlining opposition to the model. The Association’s comments highlight the harms MFN will cause to patients and providers, and the fact that the model will not achieve its stated aim of lowering drug costs. Instead, the MFN Model simply targets physicians, who do not set or control drug prices and are ethically bound to offer patients the best evidence-based treatment options for their care. In fact, at no point is reducing the price of drugs required by manufacturers in the MFN interim final rule.
ASCO also published a detailed analysis of the impact the MFN interim final rule will have on oncology practices using billing and reimbursement data from its PracticeNET network of oncology practices and cancer centers. The data, which was used to inform the amicus brief and comments to CMS, found that among PracticeNET practices, MFN-priced drugs make up 83% of all physician-provided drugs, resulting in a projected 14% reimbursement cut in year one of the model and a 52% cut in year four.
Read the Society’s full amicus curiae brief.