Archive for the ‘research’ Category

December 3, 2009

Nation’s Biomedical Research Enterprise: New Business Model Needed

Academic health centers, the core of biomedical research operations, are facing major research funding issues, as revealed in responses to a recent questionnaire from the Association of Academic Health Centers on  budgets and research costs.  Approximately 1/5 of member institutions have responded to date, and the findings raise great concern–not just for the institutions but also for the nation’s R&D, economic growth, and job development.

 The approximate amount of unrecovered costs of research for the past fiscal year ranged from 8 to 40 percent, with almost half of the institutions in the 20-40 percent range.  The same or higher amounts of unrecovered costs are projected for 2010.  Only two institutions are projecting  slight decreases of 1-2 percent.

 Academic health centers are being required to take on increasing amounts of cost sharing on grants received from the federal government. The cost sharing issue was particularly evident in funding of the clinical and translational science awards (CTSAs), an NIH program launched in 2006 to transform the conduct of clinical research through multisite, multi-disciplinary research.  CTSAs, while heralding major transformations in the nature, scope, and outcomes of biomedical research, are nevertheless an expensive undertaking. Current grantees noted cost sharing in the range of 15 to 50 percent annually, with the majority of institutions citing 25-50 percent  in cost sharing.

 Opportunities for new investigators and a strong pipeline of  talent are always significant issues and signs of stability within a system.  Such signs have not been positive for several years as reflected in the percent of first time RO1 grants awarded by the National Institutes of Health; the percentage of new RO1s have been on the decline for some time. Less interest by American students in seeking careers in academic research has also been an ongoing concern and does not speak well of the nation’s commitment to science and math education or, indeed, to higher education.

 Academic health centers are experiencing increasing difficulties to fill the gap in research funding.  Clinical practice revenues have been the traditional source of funds as academic health centers recycle monies from clinical practice into research endeavors.  Several AAHC institutions said that 95-100 percent  of funding comes from clinical revenues, which this year may be in grave danger depending on the outcome of health reform.  Indications are that physician fees will be reduced, which in turn will result in cuts in reimbursement to academic health major reductions in monies available for the research enterprise. 

 For public institutions, monies are not available from the state.  State budget cuts were noted in the range of 2-27 percent (in many instances this was the second, third, or even fourth year of decreases from the state). Decreased funding for endowments, which are particularly critical to funding at private universities,  ranged from 9.9% to 30%, last year with the majority of institutions in the 18-25% range.  For 2010, the projections for decreased funding ranged from 4-30 % for endowments and up to almost 25% for state funding.

These are only some of the critical warning signs of erosion of the research enterprise that call for review and reassessment of the nation’s commitment to and strategies for R&D and biomedical research, in particular, for the future.  With many other nations and companies throughout the world now making investment choices that will have an impact on the next decade of technology development , the U.S. choices and  policy on biomedical research are of profound importance.   The nation needs to recommit to biomedical research and consider a new business model for the research enterprise for the future–one that is viable and sustainable and competitive in a global marketplace.  This is what the Association of Academic Health Centers is now examining.  Stay tuned for updates on this important endeavor.

November 19, 2009

Mammogram Payment Leads to Empty Seat at CMS

The brouhaha about breast cancer screening is raising major concerns about who should get mammograms.  It is also heightening anxiety about whether mammograms will be paid for by Medicare and private  insurers.  Which leads me to the  Centers for Medicare & Medicaid Services (CMS), the government agency charged with responsibilities for health care  payments.  CMS, the agency with control over Medicare and Medicai,  is still leaderless even though more than a year has passed since President Obama took office. 

Secretary Sebelius, as secretary of Health and Human Services (HHS), presides over this agency and knows something about payments to insurers, having been an insurance commissioner back in Kansas.  With that background, she should know how critical CMS is to the functioning of the health care system. It is troubling that Secretary Sebelius has not taken action to fill what is the perhaps the most significant and essential slot in HHS.  At this critical juncture, there is no leadership in place to assess the structure and resources of CMS that will have the massive task of implementing any health reform legislation. 

Of great importance to academic health centers,  the Administration has not taken action on some of the most pressing issues for Medicare beneficiaries, which fall under the purview of CMS, specifically  participation of Medicare beneficiaries in clinical trials.  The current clinical trials policy hampers such participation.  In fact, the clinical trial policy threatens the nation’s ability to conduct clinical research and compete globally?  Secretary Sebelius and Mr. Sunstein, our new regulatory czar in the White House, have been made aware of the future dangers but have taken no action.   Why is CMS not an issue?  

Waiting for health reform is no answer.  The problems with CMS organization, resources, and policies will only be heightened.  Action must be taken now.  Nominating and appointing someone to head this agency is critical.