• ASH Efforts Impact CMS Modifications of Rules for Medicare Coverage of Clinical Trials
• News Headlines from Washington
• Take Action

ASH Efforts Impact CMS Modifications of Rules for Medicare Coverage of Clinical Trials

By John P. Leonard, MD, and Tracy Roades

Dr. Leonard is the Richard T. Silver Distinguished Professor of Hematology and Medical Oncology, Director of Hematology/Oncology Clinical Research Program, and Professor of Medicine at Weill Cornell Medical College.

Ms. Roades is the Research Advocacy Manager at ASH.

Last spring, CMS initiated several rounds of proposed revisions to the rules governing Medicare coverage of services provided to beneficiaries enrolled in clinical research studies.

Under the Medicare Clinical Trial Policy, first developed in September 2000, Medicare will pay for certain items and services for Medicare beneficiaries involved in clinical trials. In April, CMS issued proposed revisions to this policy. Some of these had the potential to impact the ability of patients to participate in clinical trials, and therefore could have affected clinical trial accrual and operations in significant ways. ASH submitted comments expressing concern with a number of the proposed revisions.

In commenting on CMS's proposed revisions to its coverage policy, ASH sought to ensure that Medicare beneficiaries are not, in any way, discouraged from participating in clinical trials. ASH's comments to CMS took into account comments and input from the Reimbursement Subcommittee, the Committee on Government Affairs, and the general ASH membership. These comments detailed concerns about proposed new requirements for publication of research study information, the generalization of studies to the Medicare population, and self-certification and deeming (to verify that studies meet certain qualifying criteria). In some of these areas, individual investigators and institutions potentially would have been held responsible for ensuring that new and higher standards were met to ensure that Medicare beneficiaries could participate in trials. Some of these were not fully defined or were beyond the scope of expected conduct of clinical research practice, and therefore had the potential to hinder activities in a significant way.

As a result of the comments submitted by ASH and other organizations during the agency's first reconsideration of the policy, CMS announced in a July 9 Decision Memorandum that it was backing away from the proposed changes and indicated that the agency was "issuing this national coverage determination in order to preserve the status quo with the exception of two changes" — clarifying that items or services under investigation in a clinical trial will be covered by Medicare if they would be otherwise covered outside of a clinical trial and adding language indicating that Medicare could cover routine costs in connection with clinical trials required as a result of a National Coverage Decision (NCD) based on a Coverage with Evidence Development (CED) determination.

However, after issuing the Decision Memorandum, CMS reopened the Clinical Trial Policy for a second reconsideration. ASH once again submitted comments on the proposed revisions and again focused on concerns about proposed new requirements for public release of research study information and self-certification requirements. In mid-October, CMS announced that the final policy would maintain the revisions contained in the July 9 final Decision Memorandum on the policy but negate all of the other proposed changes to the Clinical Trial Policy.

The fact that CMS has, in the end, not made major modifications to how it handles participation for Medicare beneficiaries seems to be good news for ASH members, in that clinical research in hematology and hematologic malignancies should be able to continue without new hurdles to overcome. However, CMS has indicated that it may again reopen the Clinical Trial Policy for another reconsideration in the future and that the agency may still issue one or more proposed rules to modify Medicare regulations pertaining to coverage and payment in connection with clinical trials. ASH members should be alert to updates from the ASH leadership in this area. It is clearly important to both the clinical and research missions of hematologists that clinical research efforts are facilitated rather than hindered and that Medicare beneficiaries have the opportunity to participate in clinical trials both now and in the future.

Return to Top

News Headlines from Washington

Congress Passes Six-Month Delay of Physician Payment Cut
At the end of December, Congress and the President agreed to provide physicians with a temporary reprieve from the scheduled 10.1 percent payment rate cut that was to go into effect January 1, 2008, and increase Medicare physician fees by .5 percent until July 1, 2008. The legislative fix comes as a part of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (S. 2499), which extends several programs that provide higher Medicare reimbursement rates to rural health-care providers and hospital laboratories. The legislation, however, does not address future physician fee cuts, which means the 10.1 percent cut will go back into effect after six months in the absence of additional Congressional action.

Congress Approves $133 Million Increase for NIH
After much debate, the Congress and the President finally agreed on an omnibus budget package for fiscal year 2008 that "hews closely to the White House's budget limits but shifts billions of dollars to the Democratic majority's priorities." Under the package, the National Institutes of Health (NIH) receives $28.942 billion, an increase of $133 million (+.46 percent). This includes a $294.7 million transfer to the Global AIDS Fund. The legislation provides $495.6 million for the NIH Common Fund, an increase of $12.6 million (+2.61 percent). These budget numbers are disturbing as they do not even keep pace with biomedical inflation (expected to be 3.7 percent).

In February, President Bush will release his proposed FY 2009 budget. ASH will launch grassroots campaigns to increase NIH funding appropriately and will keep the membership abreast of all developments through The Hematologist, the ASH Web site, and the electronic newsletter The Advocacy Update.

NIH Issues Anemia of Inflammation and Chronic Disease Program Announcement
Four Institutes of the NIH have joined together in a program announcement (PAS-08-019) on "Anemia of Inflammation and of Chronic Disease" (AICD). The announcement was published in the NIH Guide to Grants and Contracts (November 2, 2007). Responsive R01 applications will be accepted on standard receipt dates, beginning in February 2008. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has been joined by the National Heart, Lung, and Blood Institute (NHLBI), the National Cancer Institute (NCI), and the National Institute on Aging (NIA) in announcing this program. The purpose of the program is to promote research that will lead to a better understanding of the pathophysiology of AICD and improved methods of detection, prevention, and treatment of this common form of anemia.

The program's objective is to support research that leads to a better understanding of signaling pathways and regulatory mechanisms that affect the expression of hepcidin, ferroportin, hemojuvelin, DMT-1, and other factors involved in iron metabolism, and the development of new therapeutic strategies for AICD that may overcome erythropoietin resistance in this disorder. Other research objectives include a better understanding of how aging affects erythroid cell response to erythropoietin, iron metabolism, and red blood cell survival, and clearance, as well as a better understanding of the causes of anemia associated with hematologic and solid tumor malignancies, unrelated to cancer chemotherapy.

Return to Top

Take Action

This year, ASH will continue its advocacy efforts on several important research and practice-related issues, such as:

• Seeking increased federal funding for research
• Seeking appropriate physician reimbursement
• Supporting legislation to expand federally funded embryonic research
• Supporting legislative initiatives concerning sickle cell treatment and research
• Advocating for genetic information nondiscrimination legislation

The Society needs the help of all ASH members to bring issues important to the future of hematology to the attention of the U.S. Congress and other U.S. governmental agencies. Members of the Grassroots Network receive action alerts and information about issues in which they indicate an interest. At times, Grassroots Network members are invited to represent hematology in Washington activities, such as visits with Congress, NIH leadership, and other federal regulatory agencies. Visit the ASH Advocacy Center to take action on the Society's advocacy campaigns and join the ASH Grassroots Network.

Return to Top

Return to Table of Contents