Archive for December, 2009

December 18, 2009

The Spirit of the Season Lives Year Round in Health Professions

Dr. Philip PumerantzThe holidays are upon us once again, and as we become caught in the swirl of activities that mark this time of year, I am reminded of a quote from Benjamin Franklin: “Joy is not in things; it is in us.”

It’s easy to lose sight of that big picture when countless smaller pictures get in the way: the frenzy of holiday shopping; endless hours spent online looking for the perfect gifts, then making sure they get shipped on time; rushing to and fro from friends’ and relatives’ homes for meals and parties; candle lighting; decorating the house; packing everything we want to do with friends into our time off; and scrambling to finish work projects before the holiday break takes effect.

This splintered focus on the things surrounding the holidays, rather than on the sentiment that lies at their core, is understandably lamented. As a society, we are chided not only for our embrace of the commercial and materialistic aspects of the season, but also for an inability to consistently care about and for our fellows the way we do around the holidays. How often have we heard what a shame it is that the “spirit of the season” doesn’t last all year long, or that widespread compassion and caring don’t breach the confines of a few short weeks in early winter?

Yet, I would submit to you that the holiday spirit is in effect and on display year-round anywhere that those trained to provide health care to their fellows are putting their expertise into practice, including my institution and the many other academic health centers around the nation and the world.

Skilled hands and caring hearts know no season. They acknowledge the calendar for its effect on others, but — wholly focused on improving the lives of those who seek their help – ignore its seasonal vagaries of sentiment in favor of a consistent commitment to those who most need their attention and expertise.

This commitment to serving our fellows epitomizes “the spirit of the season,” and thus lives throughout the year anywhere compassion and caring are practiced consistently and well.  It is the greatest gift we can offer, and in its giving we shall be fulfilled.

Guest Blog by Philip Pumerantz, PhD, President, Western University of Health Sciences, in Pomona, California

December 17, 2009

Bernie Sanders and George Will Got It Right on Health Reform

Two people recognize the health reform bill is not reform and are signaling that we need to start anew. 

Sen. Bernie Sanders,  the Independent from Vermont, is telling the world that the proposed legislation is not good.  Yesterday, he said that he could not accept the health reform bill in its current form because it does not control costs or rein in health insurance companies.  More important,  Senator Sanders showed the courage of his convictions and brought a real answer to the Senate and the American people.  He proposed a single-payer amendment to the current bill.  In calling up his amendment, Sanders said, “For the first time in American history, the Senate will debate a proposal to create a single-payer, Medicare-for-all health care system.” Unfortunately, Senator Tom Coburn (R-Okla.) objected to Mr. Sanders’s request to dispense with the reading of the 767-page amendment (as called for earlier by  Coburn).  After nearly three hours of listening to a team of Senate clerks read the proposal,  Mr. Sanders gave up and withdrew his amendment (Why,  Bernie? There’s nothing to fear but fear itself.)

(Of course, Coburn knew that would be the outcome because the dealy would prevent a vote on a funding bill for the Department of Defense. The current funding provision expires at midnight tomorrow).

George Will reflects today in The Washington Post on the latest CNN poll showing that 61 percent of the public oppose what the Democratic Senate is trying to do to health care.  “It is clear what the public wants Congress to do: Talke a mulligan and start over.”

Bernie and George are both saying that what we have is not good enough.  President Obama should say the same and ask for the creation of a “super special” congressional committee to start anew in January.  Health reform before the holidays may not make the season jolly.

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December 10, 2009

Medicare Clinical Trial Policy: Health Reformers Not Paying Attention

With all the talk about Medicare in health reform, it’s troubling that no attention is being paid to access to clinical trials for Medicare beneficiaries.  The nation’s clinical trial policy (CTP), which was designed to expand participation in clinical trials by Medicare beneficiaries, is inlimbo at the U.S. Department of Health and Human Services (HHS) and both the Administration and the Congress need to wake up to a problem area.  The Association of Academic Health Centers (AAHC) has been putting the issue before policymakers for quite some time, and most recently asked the regulatory czar, Cass Sunstein, administrator of the Office of Budget and Management, to turn his attention to the CTP as well.  

  An essential step to improving health care is for the Department of Health and Human Services, specifically the Centers for Medicare & Medicaid Services (CMS) to more effectively support the innovative and life-saving therapies available during clinical research studies. The AAHC has urged the CMS to reassess the CTP to resolve the problems that emerged after its hasty establishment in 2000 but have not been addressed in an appropriate or satisfactory manner to date.

The AAHC requests CMS to revise the CTP to ensure that its intended goal of opening new realms of treatment for Medicare beneficiaries can be achieved.  

 The CTP’s current wording, and CMS’ deference to Medicare contractors in its interpretation, has produced inequitable disparities in coverage among different regions of the country. The Medicare program’s CTP, as currently constituted, not only inhibits access to clinical trials for Medicare beneficiaries, but also endangers the clinical research enterprise in the United States, by imposing a disproportionate compliance burden on the inclusion of Medicare beneficiaries in clinical trials.

 This is particularly troublesome given that the clinical enterprise is critical to having the U.S. remain a world leader in health. The aging of America’s population and the need for new treatments and cures for cancer and other diseases that disproportionately strike the elderly are the transformational forces motivating our call for change. The uneven application of the CTP has been a particular concern for our members in coverage of services during clinical trials relating to cancer, HIV and other medically and financially devastating diseases. By discouraging Medicare beneficiaries from participating in clinical trials, the CTP:

HHS needs to  ensure that  CMS acts now to:

• Reconsider the Medicare Clinical Trial Policy;

• Make immediate changes to the current CTP related to Medicare coverage to explicitly cover Phase I drug trials;

• Establish a position at CMS to oversee and coordinate Medicare coverage policy during clinical trials and to interact with other HHS agencies on clinical research; and

• Establish an interagency taskforce within HHS to harmonize regulations of CMS, the National Institutes of Health (NIH), the Agency for Health Research and Quality (AHRQ), the Food and Drug Administration (FDA) and other agencies that affect clinical research.

 

 

 

 
 

 

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.