Posts Tagged ‘association of academic health centers’

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.

 

 

 

 
 

 

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Posted in Health Reform, Policy, clinical trial policy | 1 Comment »

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.

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Posted in Policy, U.S. Economic Growth, research | 2 Comments »

October 30, 2009

House Health Reform Takes AAHC Health Workforce Recommendation: More Needed

Yesterday, House Speaker Nancy Pelosi (D-Cal.) unveiled proposed health reform legislation from the House.  Put together from the work of three House Committees the bill  includes a public option. 

Also significant, the legislation also now includes language identical to the recommendation made by the Association of Academic Health Centers (AAHC) that a permanent health workforce advisory committee develop and implement “an integrated, coordinated, strategic national health workforce policy.”  The AAHC has advocated for a national workforce planning entity because it believes that the nation’s workforce policy must be changed; the nation’s customary piecemeal approach to the workforce is no longer viable or appropriate for the 21st century.

A  comparable Senate bill is still being negotiated. The Senate should not only include such language in any final bill but also move to ensure the creation of a permanent planning entity that operates continuously, makes ongoing findings and recommendations, and is available at any time to provide consultative support to federal, state, and private health workforce stakeholders. The planning entity must serve as an active policymaking partner, not a passive advisor.

The AAHC has been urging the congressional committees and congressional leadership to broaden the scope of activity of the proposed advisory committee/national commission to fully support a strategic national policy approach.

Specifically, the AAHC recommends the following modifications be incorporated into any health reform legislation considered by the full House and Senate:

  1. Make development and implementation of an integrated, coordinated, strategic national health workforce policy the primary objective of any advisory committee or national commission.
  2.  Constitute the advisory committee or national commission as a continuously available policy research and consultative resource, not simply as a body of external experts that convenes from time to time to make periodic recommendations.
  3. Amend the enumerated issues to be addressed by the advisory committee or national commission to include the harmonization of conflicting national and state-based regulatory and private self-regulatory standards (e.g., licensure, scope of practice, accreditation).

4.    As an interim step, create a national health workforce coordinator to assess current federal capabilities and prepare agencies for their interactions with the advisory committee or national commission once it is fully functional.

 This is the way to ensure that the nation  has the health workforce it needs for the short and long-term.

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Posted in Health Reform, News, Policy, Uncategorized, health workforce | No Comments »

October 8, 2009

Include Health Workforce Planning Entity in Health Reform Legislation

It’s still not too late to put a national workforce planning entity into health reform legislation (or I am supposed to say health insurance reform).  This would neither be a commission nor a short-term advisory or research group. This would be a permanent entity–perhaps a quasi-governmental organization that has some clout–not only to bring constituencies together but also to get things done that change the shape of health workforce policy in this nation.  The goal–plan so that the health workforce can care for the American people now and in the future.

Academic health center CEOs said as much this week when they told congressional staff and representatives of national health care organizations at a congressional briefing that pending health reform legislation(including the Senate Finance Committee proposal) does not yet reflect the strategic emphasis on health workforce needed to implement successful health system reform.

  “Pending bills include numerous important workforce-related provisions, but they lack sufficient means to effectively coordinate workforce policy among federal, state, and private laws, regulations, and standards,” said Dr. Steven A. Wartman, President and CEO of the Association of Academic Health Centers (AAHC).

Dr. Wartman was joined in the panel discussion by: Dr. Nancy Dickey, President, Texas A&M Health Science Center, and Vice Chancellor for Health Affairs, Texas A&M University System, and past chair of the AAHC Board of Directors; Dr. Philip A. Pizzo, Dean, School of Medicine at Stanford University, and chair of the AAHC Board of Directors; and Dr. M. Roy Wilson, Chancellor, University of Colorado Denver, and a member of the AAHC Board of Directors.

 Dr. Wilson told the group that the nation must have a national agenda for the workforce.  Without such an effort, federal, state and local governments and agencies will continue to work in isolated silos as they attempt to solve workforce issues.

 Dr. Dickey emphasized that health workforce reform has to start today so the nation can build a viable infrastructure and rationalize our health workforce policy.  With a permanent national workforce planning body, the nation can address the full range of workforce issues — from shortages and geographic disparities, to regulatory and policy conflicts that prevent health professionals from practicing to the full extent of their training, to the paucity of reliable data on the workforce — in a comprehensive and coordinated manner.

 Dr. Pizzo cautioned that when policymakers consider changes in health care reimbursement, they must take account of the unique academic health center education and research missions, which in part are dependent on clinical revenues.  The nation must ensure that reimbursement reform does not financially undermine these academic health center missions that are so vital to the nation’s economy and its preeminence in education and research worldwide.

 “Comprehensive health workforce reform is necessary for successful health system reform, and the key to health workforce reform is creation of a permanent, ongoing health workforce planning body,” concluded Wartman.

It’s about health care.  It’s about jobs.  It’s about the economic future of the nation.  We can’t make the health workforce a second-class issue.

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Posted in Health Reform, News, Policy, health workforce | 1 Comment »

July 16, 2009

SOS on Regulatory Reform in Health Reform

I read that countless numbers of people are worried about being regulated by government in any reformed health system.   But no one, especially policymakers, seems to be addressing the regulatory infrastructure and the costs of regulation, which might open up a pandora’s box and really shed light on the extent to which the public is benefiting from the regulations developed to protect the American people (which is an issue for a longer discussion).  No one is asking whether the agencies mandated to regulate, including the Centers for Medicare & Medicaid Services,  have the resources to address implementation and enforcement of current and new regulations.  Policymakers should be addressing those resources now.  Policymakers would also do well to look at the costs of compliance for the government and for health care providers.   A 2005 study by the Association of Academic Health Centers  found that the costs of compliance  increased up to 300% in the previous decade and often more than 70% a year at academic health centers throughout the nation. We are hearing of even greater increases at the present time.  No one is denying the need for accountability and protecting quality, safety, and privacy in the health care arena.  But it may be time for the government to ask about the costs and benefits of regulation along with addressing the need for rational and ”smart” regulations.  There is also an urgent need for harmonization within the regulatory environment.  Interagency task forces have done little to ensure there is no contradiction and confusion between regulations coming out of the many government agencies.  If we really want to ensure safety and quality for the public as well as savings in health care delivery, reform of the regulatory world must be addressed now. 

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Posted in Health Reform, Policy | No Comments »