The Association of Community Cancer Centers urged the Centers for Medicare and Medicaid Services to withdraw from The Most Favored Nation Model Interim Final Rule with Comment Period due to fears of the disproportionate impact the model could have on cancer care.
The Association of Community Cancer Centers (ACC) urged the Centers for Medicare and Medicaid Services (CMS) to withdraw from The Most Favored Nation (MFN) Model Interim Final Rule with Comment Period (IFC) due to fears of the disproportionate impact the model could have on cancer care.1
“This Interim Final Rule is impractical, unworkable, and does not address the reforms necessary to protect Medicare beneficiaries and strengthen the cancer delivery infrastructure,” Christian Downs, executive director, ACCC, said in a statement. “It will have a disproportionate impact on smaller hospitals and practices which are already struggling due to the COVID-19 [coronavirus disease 2019] pandemic and force them to curtail services and access to ensure their viability.”2
The MFN model was released at the end of November to address rising drug costs by tying Medicare payment for outpatient treatments to international prices. It could have a damaging impact on cancer programs in the United States if put into effect all at once without broader payment reform. It will lower Medicare Part B reimbursement rates without increasing the reimbursement for services and cause patients on Medicare to be unable to receive the essential care and treatment they need. This model would reduce or eliminate access to appropriate care to Medicare beneficiaries and exasperate health inequalities.
ACCC is concerned that the MFN model will disproportionately affect rural and underserved cancer programs and practices with a high proportion of patients on Medicare. These programs and practices, which are typically the only options for these patients, may close, consolidate, or reduce critical services due to the decrease in reimbursement and increase in the administrative burden that would come with this model.
Downs went on to explain that ACCC has created initiatives better suited to address real-world experiences for patients with cancer enrolled in Medicare after collaborating with the Center for Medicare and Medicaid Innovation, as well as other members of the oncology community.
“We are incredibly disappointed that this extensive work is not reflected in this chaotic and disorganized model. If this Interim Final Rule goes into effect on January 1, 2021, it all but guarantees that an unsurmountable burden will be placed on our most vulnerable patients and the providers who care for them,” Downs continued.
Medicare beneficiaries’ access to the latest cancer care treatments would be limited under the new policy. To reduce prices, a portion of the savings would come from beneficiaries not being able to have access to drugs through Medicare benefits and the associated lost utilization.
“The MFN Interim Final Rule is bad policy that is contrary to law and that the administration expressly admits will disrupt patients’ access to medicines,” James C. Stansel, executive vice president and general counsel, PhRMA, said in a press release.
He also said that by proceeding with this model, the current administration will be essentially rewriting the Medicare statute, and in doing so, will circumvent the formal process required to pass new or override existing laws. “Laws must be passed by both chambers of Congress and signed by the president,” Stansel said.
As this policy is being decided on, cancer programs continue to deal with the effects of COVID-19 on their processes and patient care. The MFN model is planned to start on the first day of 2021, and ACCC believes it is unreasonable to require practices and programs to participate in a model that will obstruct patient’s access to care and the appropriate treatments during the pandemic.
“The MFN Rule restricts access to the medications that some of our nation’s most vulnerable patients rely on to optimize health outcomes, maximize quality of life, and minimize disease flares and progression,” Brian Nyquist, chief executive officer, National Infusion Center Association (NICA), stated.
“Foregoing the traditional rulemaking process to force the MFN Rule upon infusion providers is illegal and wrong. The Rule will restrict and disrupt access to care, force patients to switch from a drug that effectively manages disease to a less-effective drug for reasons unrelated to health or safety, and impair providers’ ability to provide adequate care, thereby disrupting the delicate disease management equilibrium patients have worked so hard to achieve. This will result in adverse health outcomes, reduced quality of life, increased physical and emotional burdens of disease, and increased cost to both patients and Medicare. NICA and its members firmly believe that the MFN Rule must be stopped,” Nyquist said.
ACCC also addressed the fact that healthcare costs and drug prices are issues that need action, but the major changes being proposed would cause more issues than it would solve problems. It will more likely prevent patients from receiving the type of care and treatment they require.
Andrew Spiegel, the executive director of Global Colon Cancer Association, said in a statement that “CMS must reconsider the MFN rule, and instead focus on patient-centered reforms that improve costs without limiting access to essential care.”
“The MFN Interim Final Rule should be stopped from moving forward immediately before it can cause irreparable harm,” Stansel concluded.
Reference:
1. ACCC statement on the Most Favored Nation drug pricing model. News release. ACCC. Published November 24, 2020. Accessed December 17, 2020. https://bit.ly/2K5hOel
2. Statement on litigation challenging legality of the administration’s Most Favored Nation Rule. News release. ACCC. Published December 4, 2020. Accessed December 17, 2020. https://bit.ly/2WqSqCo
Jhaveri Compares Safety and Duration of Adjuvant CDK4/6 Inhibitors in HR+ Breast Cancer
December 22nd 2024During a Case-Based Roundtable® event, Komal Jhaveri, MD, FACP, discussed dosing and toxicity concerns with the approved CDK4/6 inhibitor regimens used in the adjuvant setting for patients with hormone receptor–positive breast cancer.
Read More
Gholam Contrasts Lenvatinib With Other Options in Child-Pugh B HCC
December 21st 2024During a Case-Based Roundtable® event, Pierre Gholam, MD, discussed how post hoc and real-world analyses build upon the limited available trial data for treating patients with unresectable hepatocellular carcinoma with Child-Pugh B status.
Read More
Navigating ESR1 Mutations in HR-Positive Breast Cancer With Dr Wander
October 31st 2024In this episode of Targeted Talks, Seth Wander, MD, PhD, discusses the clinical importance of ESR1 mutations in HR-positive metastatic breast cancer and how these mutations influence treatment approaches.
Listen
Ilson Examines Chemoimmunotherapy Regimens for Metastatic Gastroesophageal Cancers
December 20th 2024During a Case-Based Roundtable® event, David H. Ilson, MD, PhD, discussed the outcomes of the CheckMate 649, CheckMate 648, and KEYNOTE-859 trials of chemoimmunotherapy regimens in patients with upper GI cancers.
Read More