Archive for the ‘clinical trial policy’ Category

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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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.

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August 18, 2009

A Real Health Reform Issue to Address: Medicare’s Clinical Trial Policy

Let’s get some real issues on the table in the health reform debate—like Medicare’s clinical trial policy.  The Medicare program is not only the key to current and future health care delivery in this nation but also the most critical link to all clinical research occurring throughout the nation. 

Good science—and new cures and treatments for a host of diseases and illnesses–require that Medicare beneficiaries participate in clinical trials.  That was the vision and purpose of the clinical trial policy, laid out in an executive memorandum signed by President Clinton in 2000.  The goal was to provide increased access for Medicare beneficiaries to clinical trials—and that is not happening. During the Bush Administration, the policy was not fulfilling its intent and, in fact, was quite dismantled, creating a situation that discouraged participation of seniors in trials.

It’s not only seniors. The President had better check his health plan because many of the government plans do not cover clinical trials—as they should. 

Health and Human Services Secretary Sebelius should be spending more time addressing this issue.  She can provide the leadership to reform Medicare’s clinical trial policy, which currently:

  • Compromises the quality and credibility of many research studies by discouraging enrollment of elderly patients
  • Limits coverage for the elderly to potentially life-saving therapies and treatments
  • Undermines the financial viability of the nation’s academic health centers where the majority of clinical trials take place
  • Increases the likelihood of an adverse impact on the nation’s economy and job market as clinical trials continue to move overseas.

The Association of Academic Health Centers (AAHC) has been at the forefront in calling for reform of the policy.  One of AAHC’s most important recommendations is for the HHS Secretary to establish the position of research coordinator at the Centers for Medicare & Medicaid Services (CMS) to oversee clinical research coverage policy.  This position would ensure that an expert with knowledge of clinical research and trials processes and operations is providing needed leadership and making the issue a national priority.

President Obama and Secretary Sebelius need to signal that they recognize the significance of Medicare’s clinical trial policy.  Appointing a permanent administrator for CMS would also be a good start.  If the Administration can’t address clinical  trial policy, there are  many on Capitol Hill who will check their health plans, suddenly wake up and take notice, and address Medicare’s clinical trial policy so they can claim some real progress on health care reform.

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