CLC Policy Issues: Clinical Trials--Medicare

Cancer Leadership Council Comments on SGR Physician Payment Reform Package
(November 13, 2013)

The Honorable Max Baucus Chairman Committee on Finance United States Senate Washington, D.C. 20510	The Honorable Orrin Hatch Ranking Member Committee on Finance United States Senate Washington, D.C. 20510
The Honorable Dave Camp Chairman Ways and Means Committee United States House of Representatives Washington, D.C. 20515	The Honorable Sander Levin Ranking Member Ways and Means Committee United States House of Representatives Washington, D.C. 20515

Dear Chairman Baucus, Chairman Camp, Senator Hatch, and Representative Levin:

The undersigned organizations, representing cancer patients, health care professionals, and researchers, write to commend your work on a legislative package that will repeal the sustainable growth rate (SGR) formula and reform the Medicare physician payment system to reward quality of care instead of volume of services.

Threatened reductions in physician payment resulting from application of the SGR formula – and the short-term solutions regularly approved over the last decade – have been unnerving to cancer care providers and patients who rely on Medicare. A resolution of the SGR problem will provide relief to the entire Medicare population, and perhaps most especially to the cancer community so dependent on Medicare.

Although the freeze in payments for the decade ending in 2023 will pose challenges to Medicare providers, the prompt movement to a value-based performance payment program and alternative payment models, accompanied by establishment of codes for care coordination for individuals with complex chronic care needs, will help ensure payment for quality care delivered by cancer care professionals.

It is gratifying that the standards for assessing performance in the value-based performance payment program include adherence to quality measures used in current payment incentive programs as well as additional measures to be developed. We also commend the clinical practice improvement activities that will be used to assess performance. The identified clinical practice improvement activities focus significantly on care coordination and beneficiary engagement, including the establishment of care plans for patients with complex needs – elements of care delivery that we believe enhance the overall quality of care for cancer patients. The availability of incentive payments for performance of these activities will help to establish them as the standard of care for cancer patients and others.

Since 2000, Medicare fee-for-service payments have been available for the routine patient care costs for beneficiaries who are enrolled in clinical trials. The clinical trials coverage policy, established by an Executive Memorandum and implemented through a national coverage decision, has had a positive impact on the enrollment of Medicare patients in cancer clinical trials. The policy of coverage of routine costs for those enrolled in trials should not be reversed as a result of the movement away from a volume-based system of care and toward a quality-based system.

We recommend several steps to protect the clinical trials coverage policy: 1) during the presumably limited time in which a fee-for-service system remains an element of Medicare payment, the clinical trials national coverage decision should remain in place, 2) in this period, an additional clinical practice improvement activity – enrollment of patients in trials testing treatments for cancer and other serious and life-threatening illnesses – should be identified, to serve as an encouragement to physicians to enroll their patients in trials, and 3) the process for certifying alternative payment models should include an evaluation element related to clinical trials, to ensure that such new models do not create obstacles to clinical trials enrollment but instead serve to encourage clinical trials participation. The interest of cancer patients, researchers, and other health professionals in the clinical trials policy is two-fold: 1) care in a trial may represent the best treatment option for a cancer patients, and for that reason we wish to eliminate obstacles to enrollment, and 2) clinical research supports an evidence-based system of cancer care and can contribute to efficiencies in the care system by avoidance of treatments that are not evidence-based.

The plan for alternative payment models and the complementary and transitional value-based performance payment program are important features of your proposal. We urge that the timeline for implementation of the alternative payment models and the procedures for developing and implementing them be outlined specifically. As additional details of the alternative payment models and the process for defining and certifying them are outlined, we recommend continued emphasis on quality measurement, including incorporation of quality measures to prevent underutilization of care and protections against inappropriate delays in access to therapeutic advances. These new payment systems should encourage delivery of quality care across the cancer care continuum, including appropriate treatment, symptom management, psychosocial care, and survivorship care.

We are pleased that, as you encourage the transition to alternative payment models that will include accountability for quality, you also establish codes for care coordination for individuals with complex chronic care needs. These codes hold promise of encouraging better coordination of care for cancer patients and others with complex chronic care needs, as the overall payment system is transformed.

Thank you again for your commitment to a patient-centered reform of the Medicare system that will sustain its viability in the face of future challenges.

Sincerely,

Cancer Leadership Council

American Cancer Society Cancer Action Network
American Society for Radiation Oncology
Bladder Cancer Advocacy Network
CancerCare
Cancer Support Community
The Children's Cause for Cancer Advocacy
Coalition of Cancer Cooperative Groups
Fight Colorectal Cancer
International Myeloma Foundation
Kidney Cancer Association
LIVESTRONG Foundation
Lymphoma Research Foundation
Multiple Myeloma Research Foundation
National Coalition for Cancer Survivorship
National Lung Cancer Partnership
Ovarian Cancer National Alliance
Prevent Cancer Foundation
Sarcoma Foundation of America
Susan G. Komen Advocacy Alliance
Us TOO International Prostate Cancer Education and Support Network

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