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Julia R. Trosman, Christine B. Weldon, R. Kate Kelley, and Kathryn A. Phillips

emergence of NGTS in clinical practice, insurance coverage and reimbursement for NGTS are becoming forefront issues: most US payers have not issued formal positive coverage policies, and some recently issued noncoverage decisions. 32 – 35 Although it is

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Saul N. Weingart, Elizabeth Brown, Peter B. Bach, Kirby Eng, Shirley A. Johnson, Timothy M. Kuzel, Terry S. Langbaum, R. Donald Leedy, Raymond J. Muller, Lee N. Newcomer, Susan O’Brien, Denise Reinke, Mark Rubino, Leonard Saltz, and Ronald S. Walters

Oral chemotherapy is emerging as a new option for well-selected patients who can manage potentially complex oral regimens and self-monitor for potential complications. If a choice between oral and parenteral therapy is available, patients may opt for oral chemotherapy because it is more convenient to administer, allows them to avoid multiple office visits, and gives them a sense of control over their own cancer care. Whether these potential advantages are maintained in regimens that combine oral and parenteral drugs is less clear. The use of oral chemotherapeutic agents profoundly affects all aspects of oncology, including creating significant safety and adherence issues, shifting some traditional roles and responsibilities of oncologists, nurses, and pharmacists to patients and caregivers. The financing of chemotherapy is also affected. To address these issues, the NCCN convened a multidisciplinary task force consisting of oncologists, nurses, pharmacists, and payor representatives to discuss the impact of the increasing use of oral chemotherapy. (JNCCN 2008;6[Suppl 3]:S1–S14)

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Andrew D. Zelenetz, Islah Ahmed, Edward Louis Braud, James D. Cross, Nancy Davenport-Ennis, Barry D. Dickinson, Steven E. Goldberg, Scott Gottlieb, Philip E. Johnson, Gary H. Lyman, Richard Markus, Ursula A. Matulonis, Denise Reinke, Edward C. Li, Jessica DeMartino, Jonathan K. Larsen, and James M. Hoffman

Biologics are essential to oncology care. As patents for older biologics begin to expire, the United States is developing an abbreviated regulatory process for the approval of similar biologics (biosimilars), which raises important considerations for the safe and appropriate incorporation of biosimilars into clinical practice for patients with cancer. The potential for biosimilars to reduce the cost of biologics, which are often high-cost components of oncology care, was the impetus behind the Biologics Price Competition and Innovation Act of 2009, a part of the 2010 Affordable Care Act. In March 2011, NCCN assembled a work group consisting of thought leaders from NCCN Member Institutions and other organizations, to provide guidance regarding the challenges health care providers and other key stakeholders face in incorporating biosimilars in health care practice. The work group identified challenges surrounding biosimilars, including health care provider knowledge, substitution practices, pharmacovigilance, naming and product tracking, coverage and reimbursement, use in off-label settings, and data requirements for approval.

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affordable medications. The second roundtable, focusing on how coverage and reimbursement impact patient care, included Joe Bailes, MD, American Society of Clinical Oncology; Al Benson III, MD, Robert H. Lurie Comprehensive Cancer Center of Northwestern

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Robert W. Carlson

objectives of the original 1993 NCCN business plan focused on coverage and reimbursement issues—developing national managed care contracts, partial or full-risk payment arrangements, and products and services for adoption by self-insured employers or managed

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Julia R. Trosman, Christine B. Weldon, Michael P. Douglas, Allison W. Kurian, R. Kate Kelley, Patricia A. Deverka, and Kathryn A. Phillips

controversy is the complexity of HCPs' insurance coverage and reimbursement. Although HCP providers may receive ad hoc payment (eg, when billing with generic or single-gene test codes, or on appeal 22 , 23 ), payers don't formally cover HCPs. 23 – 25 Our

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Ivo Abraham, Ali McBride, and Karen MacDonald

evaluations from the societal perspective, whether as general concept (“for the good of society”) or in single-payer systems in which cost-effectiveness thresholds are applied to determine coverage and reimbursement (eg, the United Kingdom). QALYs are less

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needs, and coverage and reimbursement challenges within the oncology community. The 2013 State Oncology Society Forum agenda included discussions of health information technology, the oncology medical home, new reimbursement models, and an introduction

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Leigh Gallo, Ronald S. Walters, Jeff Allen, Jenny Ahlstrom, Clay Alspach, Yelak Biru, Alyssa Schatz, Kara Martin, and Robert W. Carlson

, including CMS, could help ensure the prompt establishment of appropriate coverage and reimbursement policies for new products. Improved communications between FDA and CMS surrounding novel technologies that require different payment policies will facilitate

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Sheetal M. Kircher, Mary Mulcahy, Aparna Kalyan, Christine B. Weldon, Julia R. Trosman, and Al B. Benson III

Portability and Accountability Act of 1996 (HIPAA) and/or liability, regulatory requirements, interference with the patient–oncologist relationship, and, importantly, reimbursement concerns. 12 Although expanded coverage and reimbursement for telemedicine has