Regulation and Risk
health data. HITECH does not really dictate how this should be carried out, it just denotes the increased fines (some more then 10-fold) over the Health Insurance Portability and Accountability Act. It also gives mechanisms for enforcement, such as allowing states to prosecute on behalf of the federal government as well as allowing whistle- blowers to share in the penalties assessed.
The Patient Protection and Affordable Care Act signed into law in 2010, among many other things, codifies what was originally drafted and proposed as the Physician Payment Sunshine Act. It requires manufacturers to disclose payments to physicians and teaching hospitals for many services including research payments (even requiring the name of the item investigated). Records of these payments are to be available to the public by 2013 in searchable, easily aggregated and downloadable formats (with the exception of a waiting period for some investigational items). While advocates of transparency applaud this, critics state it is not really transparent as only revenue is included, not the actual expenses. For example, the public will see that Dr X received $100,000 from a manufacturer for research but without mention of the actual cost of the research, which could have been more than $100,000. The argument put forth is that this will inappropriately fuel public distrust due to only the ‘top side’ being published.
Medicare is becoming more aggressive in evaluating its claims, many of which pertain to research-related services. The Medicare Secondary Payer provisions especially are increasing scrutiny. Many Medicare contractors are requesting copies of the sponsor’s clinical trial agreements to assure that services Medicare is billed for are not covered in the research grant. Additionally, they are also looking to see whether language in the contract (such as a sponsor agreeing to pay for usual care items if the insurance denies coverage) would make Medicare a secondary payer, thus having the sponsor be the primary payer. This concept is furthered by specifying that a sponsor that pays for a clinical trial-related complication or injury is considered a liability insurer (including self-insurance). Such a sponsor is thus subject to the new mandatory insurance reporting provisions put forth in the recent Medicare, Medicaid and State Children’s Health Insurance Program Extension Act of 2007.7
Similarly,
1. US FDA, Disqualified/restricted/restrictions removed/assurance Lists for Clinical Investigators, FDA, 08/05/2009. Available at:
www.fda.gov/ICECI/EnforcementActions/DisqualifiedRestri ctedAssuranceList/
default.htm (accessed 2 August 2010).
2. US FDA, Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors FDA Inspections of Clinical Investigators, June 2010. Available at:
www.fda.gov/downloads /RegulatoryInformation/Guidances/UCM126553.pdf (accessed 2 August 2010).
3. US FDA, Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors Clinical Investigator Administrative Actions – Disqualification, FDA, May 2010. Available at:
www.fda.gov/downloads/RegulatoryInformation/Guidance s/UCM214008.pdf (accessed 2 August 2010).
4.
Ball MD, Cooper L, Cooper K, FDA Inspections/ Warning Letters. Presented at the ACRP 2010 Global Conference.
5. US FDA, Press release: FDA Commissioner Sets Out Vision on Enforcement to Support Public Health FDA, 6.8.09. Available at:
www.fda.gov/NewsEvents/Newsroom/PressAnnounceme nts/
ucm176119.htm (accessed 2 August 2010).
6. 7.
Vulcano D, Trends in FDA Warning Letters to IRBs, Presented at the ACRP 2007 Global Conference. Centers for Medicare and Medicaid Services, CMS ALERT:
8.
Clinical Trials & Liability Insurance (Including Self-Insurance), No-Fault Insurance, and Workers’ Compensation, CMS, 26 May 2010.
Centers for Medicare and Medicaid Services, CMS ALERT Regarding Risk Management Write-Offs for Liability Insurance (Including Self-Insurance), No-Fault Insurance, and Workers’ Compensation, CMS, May 26, 2010.
9.
Gilbert C, Bower JL, Disruptive change. When trying harder is part of the problem, Harv Bus Rev, 2002;80(5): 94–101,G 134.
10. Koski G, Ethics, Science, and oversight of critical care research, Am J Resp Crit Care Med, 2004;169:982–86.
a provider who writes off a charge for an injury or complication may have reporting requirements.8
Conclusion
Arguably, this heightened scrutiny can be equated to the business concept of ‘disruptive change’, in that it is a change that causes a fundamental shift in an industry. One great article on dealing with disruptive change was published in the Harvard Business Review.9 The authors stated that many businesses treat disruptive change as a threat and over-react to it. Businesses can, for example, overexcite the industry or commit too many resources, along the lines of what former Director of OHRP Greg Koski called ‘reactive hyperprotectionism’. According to Koski, this, ‘can have a stifling effect on research productivity without meaningfully enhancing the safety and well-being of research participants.’10
Some businesses
see disruptive change as an opportunity, yet commit insufficient resources to it. The authors advocate that when faced with disruptive change, companies should make good use of the adrenaline a threat causes and the creativity an opportunity creates. Certainly such an attitude should be taken here.
New therapeutics need to be and will be found. Healthcare delivery needs to be and will be advanced. Clinical trial subjects need to have adequate protection of their rights and well-being and well trained and ethical investigators are needed to make all that happen. n
David M Vulcano is the Assistant Vice President and Responsible Executive for Clinical Research for the Hospital Corporation of America (HCA), and oversees the research efforts of over 160 hospitals, over 100 surgery centres, various physician practices and affiliated programmes in the US and the UK. He is Certified Institutional Review Board (IRB) Professional (CIP) registered and holds the Regulatory Affairs Certification (RAC). Mr Vulcano is the Immediate Past
Chair of the Board of Trustees for the Association of Clinical Research Professionals (ACRP), the largest international membership organisation and certifying body for the clinical research profession, and is a former Board Member for the Health Information Technology Standards Panel (HITSP), whose function is to integrate electronic health records and clinical trial management systems. Mr Vulcano has a Master’s degree in both Social Work and Business Administration.
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DRUG DEVELOPMENT
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