ASCO voiced its strong opposition to the proposed Medicare Part B demonstration project in comments submitted on June 28 for the U.S. Senate Finance Committee hearing, “Examining the Proposed Medicare Part B Drug Demonstration.” ASCO underscored the urgent need to advance a fairer and more responsible payment system for oncology than what is offered in the ill-advised proposal from the Centers for Medicare & Medicaid Services (CMS)—calling on CMS to withdraw the proposal or urging Congress to intervene before this flawed experiment irreparably harms the cancer care delivery system.
“The assumptions and emphasis of the Part B Drug Payment model are misplaced,” said ASCO President Daniel F. Hayes, MD, FASCO, in the statement. “If CMS’s goal is to lower drug prices, this demonstration is not designed to achieve that outcome. Rather, the proposed demonstration places doctors and Medicare beneficiaries in the position of making impossible choices without directly addressing the underlying problem of high drug prices.”
Specific Concerns
ASCO’s specific concerns regarding the Part B demo include:
- An Experiment on Patients Without Safeguards—ASCO asserts that Phase 1 of the demo is essentially a mandatory experiment on seniors with cancer but without accepted patient safeguards in place. Patients cannot opt out of the demo and receive no informed consent, as is mandatory in ethical clinical research. Further, there is also no way to monitor potential adverse consequences in real time.
- Demo Would Likely Increase “Underwater” Drugs—CMS based the demo on the faulty assumption that a Part B drug reimbursement rate of average sales price (ASP) plus 2.5% will cover drug acquisition costs. The 2% Medicare sequestration cut will apply to Part B drugs under the demo and reduce the real-world rate to ASP plus 0.86% with an add-on fee of $16.53 per drug per day—a rate that is effectively “underwater” for many cancer treatments. In other words, CMS would likely reimburse practices for less than the acquisition cost of many oncology drugs—possibly forcing many independent oncology practices to send their Medicare patients to other higher-cost facilities for treatment.
- Shifting Site of Care Problematic—The Part B demo would remove resources from practices as they prepare for changes under the Medicare Access and Chip Reauthorization Act (MACRA). This could disrupt the site of care for Medicare patients with cancer, work against the goals of MACRA, and increase the costs to the system overall.
- Part B Demo vs the Oncology Care Model—The proposed rule also runs counter to the care improvement efforts embedded in CMS’ own Oncology Care Model (OCM). Medicare currently offers little or no payment for most of the care cancer patients need: treatment planning, patient education, patient and family counseling, coordination of care, mental health and other emotional support services, quality improvement, patient navigator services, triage nurse services, genetic counseling services, financial counseling services, nutrition counseling and dieticians, and community outreach. While CMS appears to have acknowledged this payment gap for such services by adding a monthly payment into OCM specifically designed to support care transformation, they are the very services that will be put at risk under the Part B demo. ■