Biotechnology Healthcare - November/December 2008 - (Page 43) tions including individuals, grants from such organizations as the Robert Wood Johnson Foundation, and collaboration with state government programs. The pharmaceutical industry, however, remains the largest donor to CFs, contributing roughly 90 percent of PSI’s funding and 95 percent of the PAN Foundation’s funding, for example (PSI 2006, PAN 2008). Although the antikickback statute outlaws the earmarking of industry gifts for specific medications, donors can designate funds for a specific disease that may, coincidentally, have only one or two drug options. ETHICAL CONSIDERATIONS Some newer CFs have been criticized for stretching the limits of their legal relationships with drug companies, and thus being de facto for-profit entities. The two largest CFs, HWF and the PAN Foundation, were created by independent, for-profit healthcare consulting companies. New Jersey-based Covance provides comprehensive drug development services including “launching and marketing a drug” (Covance 2008). In 2003, Covance helped to launch HWF, providing additional services and administrative personnel who still remain on Covance’s payroll. However, HWF has IRS-designated 501(c)(3) notfor-profit status. The Office of the Inspector General of the U.S. Department of Health and Human Services has issued specific guidelines for these foundations, deeming them allowable as long as there is a distinct firewall between business and the foundation (DHHS 2004). Support from any company, pharmaceutical or otherwise, provides advantages and disadvantages to other CFs and to patients. The PAN Foundation works in association with Lash Group, a healthcare consulting company that focuses on Web-based support and other services to resolve issues with patient support and education, billing, and reimbursement for medical products. Lash Group provides technical support and Web site development for the PAN Foundation. This reduces the foundation’s overhead — such costs accounted for 2.9 percent of the foundation’s operating costs in 2007 — and allows a larger percentage of donations to go directly to patients in need (PAN Foundation 2008). In comparison, administrative costs absorb 10–20 percent of donation monies of other CFs (NORD 2006). Although there are regulations for 501(c)(3) organizations, clear variations exist between these CFs in practice. The larger question is, how will CFs affect American healthcare? The PAN Foundation (2008) estimates that CFs address only 10–15 percent of the financial-assistance needs of the insured. The baby boomer population is aging will live longer with chronic diseases. Medicare Part D leaves a donut hole in the coverage for those who are insured. Novel drugs enter the market with high prices, many with protection from competition through orphan drug status. Factor in the potential for healthcare reform, and the only certainties are that the number of people without adequate insurance will continue to rise and that the need for CFs will remain. It may be difficult to be completely comfortable with certain CFs having not-for-profit status. Such status allows biopharmaceutical companies — the largest contributors to CFs — to gain huge tax deductions. At the same time, however, CFs dispense millions of dollars in funds to patients, enabling more people to pay for expensive medications. These are important considerations in any discussion about ethics. CFs can help to defuse this issue by striving to decrease their dependence on pharmaceutical industry funding, partnering more with state programs and investing prudently. Concurrent changes in the financing of healthcare may ultimately improve coverage of the underinsured by encouraging a cost- effective model of healthcare delivery. Until then, perhaps CFs should be considered a godsend, regardless of their financiers. REFERENCES Chronic Disease Fund. Problems and solutions. «http://www.cdfund.org/ Who%20We%20Are/Problems Solutions.aspx#Solutions.» Accessed Oct. 31, 2008. Covance. Covance company overview. «http://www.covance.com/aboutcvd/ index.php.» Accessed Nov. 4, 2008. DHHS (Department of Health and Human Services) Office of the Inspector General. OIG Advisory Opinion 0415. 2004. «http://www.oig.hhs.gov/ fraud/docs/advisoryopinions/2004/ao 0415.pdf». Accessed Oct. 31, 2008. Harris B. Personal communication. March 2008. HWF (HealthWell Foundation). HealthWell Foundation fact sheet. «http://www. healthwellfoundation. org/News/HW%20fact%20sheet.pdf». Accessed Oct. 31, 2008. NORD (National Organization for Rare Disorders). Annual Report 2006. «http://www.rarediseases.org.» Accessed Oct. 31, 2008. PAN (Patient Access Network) Foundation. Report 2007. «http://www. patientaccessnetwork.org.» Accessed Oct. 31, 2008. Patient Advocate Foundation. Annual Report 2006/2007. «http://www.patient advocate.org/pdf/annual_report/annual 06_07.pdf.» Accessed Oct. 31, 2008. PSI (Patient Services Incorporated). 2006 annual report. «http://www.uneedpsi. org.» Accessed Oct. 31, 2008. Disclosure Tina Shah, MD, reports no financial arrangement or affiliations with organizations mentioned in this article or manufacturers’ proprietary products. NOVEMBER/DECEMBER 2008 · BIOTECHNOLOGY HEALTHCARE 43 http://www.cdfund.org/Who%20We%20Are/ProblemsSolutions.aspx#Solutions http://www.cdfund.org/Who%20We%20Are/ProblemsSolutions.aspx#Solutions http://www.cdfund.org/Who%20We%20Are/ProblemsSolutions.aspx#Solutions http://www.covance.com/aboutcvd/index.php http://www.covance.com/aboutcvd/index.php http://www.oig.hhs.gov/fraud/docs/advisoryopinions/2004/ao0415.pdf http://www.oig.hhs.gov/fraud/docs/advisoryopinions/2004/ao0415.pdf http://www.oig.hhs.gov/fraud/docs/advisoryopinions/2004/ao0415.pdf http://www.healthwellfoundation.org/News/HW%20fact%20sheet.pdf http://www.rarediseases.org http://www.patientaccessnetwork.org http://www.patientaccessnetwork.org http://www.patientadvocate.org/pdf/annual_report/annual06_07.pdf http://www.patientadvocate.org/pdf/annual_report/annual06_07.pdf http://www.patientadvocate.org/pdf/annual_report/annual06_07.pdf http://www.uneedpsi.org http://www.uneedpsi.org
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