Fall is in the air and the Department of Health and Human Services, Office of Inspector General is busy beginning their implementation of the Fiscal Year 2010 Work Plan.
The 2010 Work Plan is 115 pages of activities, programs and operations that will be the focus of OIG activity over the coming fiscal year. As in past years, the 2010 Work Plan is split up between those functions related to the Centers for Medicare Services (Medicare, Medicaid, information systems controls, the Children's Health Insurance Program and related investigation and legal counsel) and those functions related to Public Health and Human Services Programs and Department-wide Issues (Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institutes of Health, the Administration on Aging and the Administration for Children and Families, as well as department-wide issues/financial accounting and information systems management).
A review of the 2010 Work Plan finds the OIG continuing its focus on manufacturers – although its focus appears to be a little more discreet this year. In 2009, the OIG's Work Plan included 12 different programs/operations related to the Food and Drug Administration. Compare that to the 2010 Work Plan, which only has seven. One of the new programs entails the OIG's review of the FDA's process for evaluating investigational new drug applications. The OIG notes that it will assess the FDA's "timeliness" and will identify challenges to the IND process.
The OIG is interested in payments made for off-label uses of anti-cancer pharmaceuticals and biologicals. The Work Plan notes that, in 2007, Medicare payments for anti-cancer drugs totaled almost $2.7 billion. With such a large price tag on the drugs, the OIG is going to "determine whether patients with particular indications were prescribed drugs approved by FDA before resorting to drugs not approved for those indications" (emphasis added). This raises the question whether OIG will be reviewing medical decisions as well as manufacturer promotional activities.
The OIG continues to be concerned about financial interests held by those who receive National Institutes of Health Research Grants. In 2009, the focus was a more general conflict of interest. This year, the OIG notes: ". . .[A]s of 2009, there are no Federal regulations to provide guidance on the handling of financial conflicts of interest that may exist within grantee institutions. Our previous work has identified instances where grantee institutions were receiving financial payments from the same companies that they believe created a conflict of interest for the researchers." Calling Senator Grassley, anyone?