Clinical Research Billing and CMS Coverage Analysis Challenges CCAF Spring 2014 Conference Beverly Ginsburg Cooper Senior Director and Lead, Cancer Center Service Team Huron Consulting Group

The Regulatory Climate: Overview Clinical research billing compliance continues to be a high priority concern of cancer centers and their institutions In 2000, President Clinton first issued the executive memorandum directing Medicare payment for routine patient care costs and costs due to medical complications associated with clinical trial participation Many states and insurers followed Medicare’s lead Regulations and guidance from CMS remains unclear In 2011, HHS Secretary Sebelius stated that HHS has begun to address inconsistencies Institutions bear the responsibility and consequences of misinterpretation 2

The Regulatory Climate: Challenges Ahead CMS created an integrated data repository for Medicare, Medicaid, and liability claims data to be used in identifying improper payments Health care reform legislation Increased funding for Medicaid fraud and abuse control Cancer Centers and academic institutions are settling cases with the government 3

Noteworthy Settlements 4 Rush University Medical Center Voluntary Disclosure University of Alabama Emory University/ Winship Cancer Center Whistleblower

Research Billing Requires an Integrated Team Approach 5 5 © 2014 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. The research billing process is complex and requires coordination and harmonization between partnering institutions (the hospital, the physician practice plan, and where applicable, the university). The steps in the process are: Coverage Analysis Budgeting and Contracting Identifying and/or Flagging Research Patients Registration and Admission (Including Pre-authorization) Charge Segregation Coding Claims Processing and Invoicing Study Close-out and Residual Balances

Coverage Analysis Defined 6 A systematic review of protocol- related documents to determine if all the patient care costs in a study are covered by the study sponsor, other funding sources, or qualify for reimbursement by third party payers.

Why This Sounds Simple…But Isn’t Federal policy is vague When left to interpretation, institutions can interpret incorrectly Therapeutic intent Standard of care Billable research services Some centers have pushed the limits to maximize revenue PI and staff may not know the rules Checks and balances may not in place to catch problems 7

Examples of Common Billing Errors Billing services covered by sponsor Billing services promised for free in Informed Consent Billing services that are not “medically necessary” 8

9 Elements of Clinical Research Billing Compliance Program Coverage Analysis : Blueprint of SOC and research charges that meet the reimbursement rules Revenue Cycle Management : Policies and procedures to direct the processing of SOC and research charges Training and Development: Advance competencies is research billing Auditing and Monitoring: A plan to maintain low error rate and monitor impact of training Communication and Technology: a plan to increase awareness and facilitate compliance 9 © 2011 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential. © 2014 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential.

Advantages 10 Enables early detection of non-covered items and services Reduces inappropriate billing Facilitates ability to recover allowable costs Reduces risk of fines and loss of reputation

Panelists Ashley Baker Lee Current: SVP, Research Operations City of Hope Prior: CAO, John Wayne Cancer Institute Michael Bertram Current: Administrator, UAB Cancer Center Prior: Administrator, UAB CFAR 11