Quality of the estimate. December, p. 47 - Health Care Compliance ...

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Regulatory compliance for research in an academic medical center ...continued from page 33 December 2011 34 therapy administered to hospital patients be approved by the IRB and Department of Research in accordance with hospital policies (e.g., IRB, HIPAA). In addition, contractual language between MIHS and the Physician Practice Group delegated to MIHS the authority to enter into clinical research study agreements with study sponsors for and on behalf of the Physician Practice Group and its qualified providers (i.e. study Principal Investigators). The contract further authorized MIHS to act as the fiduciary agent for the Physician Practice Group and its qualified providers under any clinical research study. Although the language of this contract offered the mandate to centralize clinical research operations and manage all aspects of the research within MIHS, buy-in from a broad range of individuals within MIHS and the Physician Practice Group was also needed. A quarterly research advisory board, composed of physician/ scientists, departmental chairs, the chief compliance officer, the vice president of Finance, and the Department of Research senior management team was instituted. At the first meeting, the Department of Research committed to resolving the major concerns of the key physician/ scientists by: n making research administration a transparent process, n reducing the time from contact initiation to the successful launch of clinical trials, n increasing research revenue, and n providing timely and accurate financial reporting of research accounts. Within the first year, the Department of Research met or exceeded all of the commitments and gained the recognition and respect of key opinion leaders in the clinical departments. We built on the success of the first year by engaging the Finance division to support operations for research grants accounting, and implementing policies for administration of research accounts (see below). This led to increased revenue capture and improved reporting, which in turn improved our performance measures for the key constituents. We have continued this process by offering ongoing educational programs to target audiences to provide information about different components of research compliance. Step 3: The Institutional Review Board Although the IRB had originated at MIHS during its prior life as the county hospital, the establishment of research administration at MIHS required the development and implementation of a new set of policies and procedures to better meet federal regulations on human subject protection, conflict Health Care Compliance Association • 888-580-8373 • www.hcca-info.org of interest, scientific misconduct, informed consent, and more recently, HIPAA Privacy Rule and Health Information Technology Act (HITECH) compliance. The assurance that all protocols, contracts, and grants are compliant with HIPAA rules for the use and disclosure of protected health information (PHI) for research is shared with the Compliance department. Annual training in the definition of and MIHS policies for scientific misconduct, conflict of interest, and HIPAA/HITECH rules is provided by the Department of Research. In addition, because the majority of residents are engaged in research activities, the Department of Research provides courses in research design and statistical design annually to all residents. IRB protocols are developed with support and guidance by the IRB Office for all new investigators (including residents) and in conjunction with clinical research coordinators for industrysponsored studies. All protocol documents are reviewed to meet the required informed consent and information documentation (e.g., brochures) and to determine the need for language translation. The translation of the documents and informed consent to the patients and families are the coordinated responsibility of the Principal Investigator and the translation services within the Department of
Community Relations. A process to reduce the time to review and translate the documents was developed during 2009. The review of the process was initiated because our collaborative research partner institutions expressed concern that there was significant variability in the process. This was due, in part, to the review of the protocols and translation of documents among separate partner or collaborator IRBs. After the execution of a Memorandum of Understanding for Research and Graduate Education Partnerships between MIHS and a partner university, an IRB reciprocity agreement was executed that determines IRB authority over joint research programs where clinical research is conducted solely at MIHS. By stipulating that MIHS would be the IRB of record, the agreement ensured there would be a single review of the protocols and translation of documents, which has resulted in a significant reduction in the time needed for review and approval. For other partner institutions, master agreements were executed that stipulated the IRB of record and authority for translated documents, resulting in greater efficiency for approving individual research agreements. Step 4: Contracts and billing All financial activities related to clinical research were centralized during the Department of Research’s second year of operation. Accountabilities and controls were developed to ensure invoicing uniformity for all research studies with billable items and services, as well as research billing compliance throughout MIHS. All grant and contract-related budgets are initially processed through the Department of Research for prospective reimbursement analysis, budget development, and budget negotiation. In addition, the post-award team is charged with the review of billing issues and developing a process for invoicing for each study. At the time that the author assumed his current position (Director of the Department of Research) there was no specific plan for cost accountability or cost recovery for the department and its activities. The first step towards a full accounting was to realign the administrative structure (see Step 1) to reflect the principle differences in cost recovery for the activities of the department. The industry-sponsored Contracts and Clinical Trial Oversight division is responsible for activities that can provide a stable stream of income that is over and above the cost of administering the activities of this division. This occurs through direct costs billed to the clinical trials for the clinical research coordinator (CRC) staff and the indirect rate cost recovery Health Care Compliance Association • 888-580-8373 • www.hcca-info.org from each clinical trial managed by the Department of Research. The goal for each budget year is to add CRC staffing only as the income generated from the clinical trials is able to fully support the additional positions. Obviously, bottlenecks during any step of the process, from initial contact by the clinical research organization (CRO)/sponsor, through contract negotiations, recruitment issues, and physician oversight, limits growth in research activities and income. To reduce the amount of time required for contract negotiation and to simultaneously improve consistency in the process, we worked with district legal counsel to develop a master language guide that detailed the information that was required to be included in any research contract. Each contract is reviewed for conformity and compliance with the template, including intellectual property protection language, and then submitted with a list of proposed changes in language for review by legal counsel. An edited research contract is developed in a short period of time and returned to the CRO/sponsor for revision. In part, because of the consistency of our approach, repeat contract negotiations with CROs/sponsors has resulted in developing master agreements to support a process for limited review and approval. A similar approach has been taken with non-commercial sponsors of research for review of Continued on page 36 December 2011 35
Page 1 and 2: Volume Thirteen Number Twelve Decem
Page 3 and 4: INSIDE 5 The rising tide: Recognizi
Page 5 and 6: The rising tide: Recognizing your c
Page 7 and 8: Legal function of any consulting ar
Page 9 and 10: side and show that proper actions w
Page 11 and 12: If you disagree with the requested
Page 13 and 14: n Starting from Scratch o I just re
Page 15 and 16: CFO was particularly timely in ligh
Page 17 and 18: territory in the early years. The m
Page 19 and 20: Social Networking John Falcetano Ed
Page 21 and 22: y the federal and state agencies th
Page 23 and 24: People on the Move Former Medicaid
Page 25 and 26: may find themselves in a netherworl
Page 27 and 28: Losing sleep over health care marke
Page 29 and 30: Editor’s note: Jeffrey N. Joyce i
Page 31 and 32: The first domain for establishing r
Page 33: for research services provided by p
Page 37 and 38: With the implementation of the EMR
Page 39 and 40: showed that the company viewed its
Page 41 and 42: Healthcare facilities that are seri
Page 43 and 44: CCB The Compliance Professional’s
Page 45 and 46: Legislators viewed the Medicare RAC
Page 47 and 48: Confidence and precision in claims
Page 49 and 50: universe is no less than $9,650. No
Page 51 and 52: Accountability is the key to compli
Page 53 and 54: Accountability is the key to compli
Page 55 and 56: Regulatory compliance for research
Page 57 and 58: Occupational Fraud and Abuse, it is
Page 59 and 60: offenses, including modification of
Page 61 and 62: n Control environment The control e
Page 63 and 64: organization is complying with regu
Page 65 and 66: Publisher: Health Care Compliance A
Page 67 and 68: esearch Compliance Conference June
Page 69 and 70: eimbursement and the growing separa
Page 71 and 72: even a decrease in physician paymen
Page 73 and 74: New HCCA Members Alabama n Patricia
Page 75 and 76: What could you do with The Power of

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