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

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Losing sleep over health care marketing arrangements ...continued from page 27 December 2011 28 low level of risk that [it] should protect it.” As noted above, the OIG’s reasoning is open to question. However, as a practical matter, providers need to take the OIG’s position carefully into account when they structure and evaluate any proposed marketing arrangement. Providers may wish to consider the following steps in order to reduce the inevitable legal risk that marketing arrangements present. n Fair market value determination. Providers should carefully document the means by which they determined the proposed amount and methodology of compensation to marketers is fair market value, particularly where compensation reflects success of marketing efforts. The strongest documentation can be obtained by engaging an independent valuation expert. In all cases, factors to examine may include (1) the expected costs the marketer will incur; (2) the expected time the marketer will expend, and a fair market value hourly rate for these services; (3) excluding any referrals generated directly by the marketer (e.g., by a medical director that the marketer furnishes as part of a broader range of services for the provider) from the compensation formula; (4) the expected costs to the provider if it performed the marketing services itself; (5) fees paid in similar arrangements, to the extent the parties have this information; and (6) fee quotations the provider obtains from other potential marketers. n Compliance program and contractual protections. In order to reduce the risk of improper activities, providers should require, in writing, that marketers abide by the provider’s compliance program and procedures. Among other elements, this should require marketers to utilize only truthful and accurate materials, and to ensure that its staff is adequately trained to make communications that are accurate and non-coercive. Further, the marketer should be contractually obligated to indemnify the provider for any failure to abide by the written contract (including the foregoing requirements), the provider’s compliance program, or applicable law. Finally, the provider should immediately investigate any complaints of possible impropriety by the marketer, whether those complaints arise from the provider’s own staff or from the community. n Review of marketing materials. The provider should consider requiring and performing prior review of all written marketing materials. If questions arise as to the propriety of any materials, the provider should consult legal counsel. Similarly, the provider Health Care Compliance Association • 888-580-8373 • www.hcca-info.org should consider requiring written, preapproved “scripts” for any marketing presentations and telephone calls. Conclusion Although it may be difficult or impractical to structure an arrangement to be risk-free (other than those rare arrangements that meet the safe harbor), prudent structuring, documentation, and monitoring can give providers considerable comfort in implementing marketing arrangements that are effective and beneficial, while at the same time not posing undue legal risk. n 1. 56 Fed. Reg. 35952, 35974 (6/29/91). 2. 42 C.F.R. §1001.952(d) 3. 42 C.F.R. §1001.952(d)(3). 4. See, e.g., Advisory Opinions 03-08 (4/10/03), 08-19 (10/29/08). 5. See Advisory Opinions 99-3 (3/16/99), 98-10 (8/31/98) and 98-4 (4/15/98). 6. Advisory Opinion 10-23 (10/28/10). 7. See Advisory Opinions 99-12 (11/23/99), 99-3 (3/16/99) and 08-19 (10/29/08). 8. See Advisory Opinion 99-8 (7/6/99). 9 See Advisory Opinions 99-3 (3/16/99) and 98-10 (8/31/98). 10. See Advisory Opinion 99-8 (7/6/99). 11. See Advisory Opinion 99-8 (7/6/99). See also 56 Fed. Reg. 35952, 35974 (6/29/91). 12. Advisory Opinions 10-23 and 10-24 (both issued 10/28/10).
Editor’s note: Jeffrey N. Joyce is the Director of the Department of Research at Maricopa Integrated Health System in Phoenix. He may be contacted by e-mail at Jeffrey. Joyce@mihs.org. Traditional academic medical centers that have a teaching hospital associated with a medical school have been the home for clinical and translational research for several decades. However, increasing amounts of research are being conducted at free-standing hospitals, particularly those providing residency training. Maricopa Integrated Health System (MIHS) is headquartered in the heart of a large urban area. The cornerstone of MIHS is Maricopa Medical Center (MMC), a major teaching hospital with a 100-year history. By public vote, MIHS (including MMC) became an independent health care district governed by a five-member board of directors in 2005. The stand-alone medical system, hosting ten residency Regulatory compliance for research in an academic medical center By Jeffrey N. Joyce, PhD programs that train 275 residents annually, established the Department of Research in 2006. The Department of Research was created to meet several goals, but the driving need was to strengthen financial and regulatory oversight while simultaneously reducing barriers to conducting research. Another important driving force was the MIHS intention to assume the role of a major university-affiliated teaching hospital and clinical hub for its research partners, and thus, to increase clinical research opportunities. Senior leadership developed goals in 2006 that required rapid growth of research administration and support, and called for the establishment of regulatory policies and processes that did not currently exist. This article will describe the planning, development, and implementation of the policies and processes that were aligned with the departments of Information Technology (IT), Finance, and Revenue, as well as Health Care Compliance Association • 888-580-8373 • www.hcca-info.org with the Legal and Compliance areas. This information-driven process can be used to develop an effective research administration operation in other independent academic medical centers. Establishing an effective research infrastructure In 2005, the MIHS Institutional Review Board Administrator and Acting Director of Academic Research prepared a white paper that assessed the value of the research division that had been administered on behalf of MIHS by its Physician Practice Group for the previous three years. The white paper concluded that the research division provided some coordination that had long been lacking, but weaknesses and barriers remained. Three goals were identified that needed to be addressed: (1) Centralize the oversight and review of research that assured financial accountability for research funds; (2) Provide for the assurance of appropriate billing for research patients; and (3) Professionalize the research contract approval process and oversight. In 2007, a new Director of Research (the author) was appointed, and a plan was implemented to improve research administration by hiring an experienced team to manage the clinical research contracts and academic grants, and to restructure December 2011 29
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: Losing sleep over health care marke
Page 31 and 32: The first domain for establishing r
Page 33 and 34: for research services provided by p
Page 35 and 36: Community Relations. A process to r
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
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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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