July 2007 Advocacy Update

CMS Issues Decision Memorandum on Proposed Revisions to Medicare Clinical Research Policy; ASH Recommendations and Concerns Incorporated
On July 9, the Centers for Medicare and Medicaid Services (CMS) issued a final Decision Memorandum on proposed revisions to rules governing Medicare coverage of services provided to beneficiaries enrolled in clinical research studies.

Since the September 2000 issuance of the original National Coverage Decision (NCD) on this issue, Medicare has paid for the routine costs of beneficiaries enrolled in qualifying clinical trials. In April, CMS issued proposed revisions to this policy, and ASH submitted comments expressing concern with a number of the proposed revisions. ASH's comments focused on concerns about proposed new requirements for public release of research study information, the generalization of studies to the Medicare population, and self-certification and deeming.

As a result of the comments submitted by ASH and other organizations, CMS announced in its final Decision Memorandum that it was backing away from the proposed changes and indicated the agency was "issuing this national coverage determination in order to preserve the status quo with the exception of two changes."

The first change clarifies that items or services under investigation will be covered by Medicare if they would be otherwise covered outside of a clinical trial. ASH's comments to CMS had supported this clarification in order to ensure that all Medicare beneficiaries are treated equally in terms of coverage, regardless of whether they are enrolled in a clinical research study.

This clarification will change the wording of the Policy to now read:

"Routine costs of a clinical trial include all items and services that are otherwise generally available to Medicare beneficiaries (i.e., there exists a benefit category, it is not statutorily excluded, and there is not a national noncoverage decision) that are provided in either the experimental or the control arms of a clinical trial except:

• The investigational item or service, itself, unless otherwise covered outside of the clinical trial."

The second change adopted by CMS adds language indicating that Medicare could cover routine costs in connection with clinical trials required as a result of a NCD based on a Coverage with Evidence Development (CED) determination. While CMS notes it is "aware of the burden CED could potentially place on providers, practitioners, beneficiaries and sponsors/investigators," the agency believes that the coverage of services that would not otherwise be covered outweighs the administrative burden.

The following language will be added to the current policy to reflect this modification:

"The Centers for Medicare & Medicaid Services, through the national coverage determination (NCD) process, through an individualized assessment of benefits, risks, and research potential, may determine that certain items and services for which there is some evidence of significant medical benefit, but for which there is insufficient evidence to support a 'reasonable and necessary' determination, are only reasonable and necessary when provided in a clinical trial that meets the requirements defined in that NCD."

CMS also indicated in the final Decision Memorandum that it intends to reopen the Clinical Trial Policy for a second reconsideration and that the agency will issue one or more proposed rules to modify Medicare regulations pertaining to coverage and payment in connection with clinical trials.

CMS Publishes Proposed 2008 Medicare Physician Fee Schedule Rule
CMS has published its Proposed 2008 Medicare Physician Fee Schedule Rule. Comments will be accepted through August 31, 2007. The final physician fee schedule rule will be published around November 1 and will be effective for services rendered on or after January 1, 2008.

CMS has proposed reducing physician payments by 9.9 percent in 2008. ASH is very involved in working with Congress to avert these drastic cuts. For the past five years, estimated cuts to the Medicare physician payment rate have been temporarily avoided through legislation. Currently, congressional committees in the U.S. House of Representatives are working on legislation to address Medicare physician payment that they hope to have voted on by the end of July. However, even with congressional action the best scenarios would be a .5 percent increase or a freeze in the 2007 conversion factor in 2008.

The proposed rule also includes several changes in the calculation of practice expense values, revisions to geographic practice cost indices, new requirements for reporting anemia quality indicators, provisions related to the 2008 Physician Quality Reporting Initiative (PQRI) program, etc. For more details and a summary of the proposal, please view ASH's Practice Update for July.

ASH members are also strongly encouraged to join ASH's online advocacy campaign to prevent the physician payment cuts. Through ASH's Advocacy Center physicians can quickly and easily contact their Members of Congress to urge a positive physician update.

House Panel Approves HHS Spending Bill
The House Appropriations Committee approved its FY 2008 Labor-HHS-Education spending bill on July 11. In general, the committee endorsed the funding levels approved by the Labor-HHS-Education Subcommittee in early June. For NIH, the bill includes $29.650 billion, an increase of $750 million (2.6 percent) above the current year's funding level; however, the bill also increases the amount of the transfer from NIH to the Global HIV/AIDS fund from the $99 million in FY 2007 to $300 million in FY 2008, which means the net increase in the NIH budget is $549 million (1.9 percent) over FY 2007.

The bill also includes $228.3 million for Title VII health professions programs, a $43.6 million (23.6 percent) increase over FY 2007. The bill is scheduled to go to the House floor July 17.

ASH members are encouraged to visit the ASH Advocacy Center for more information about FY 2008 NIH funding and to participate in ASH's most recent online advocacy campaign on this issue.

NIH Issues Request for Information on Peer Review Process
NIH recently released a "Request for Information" seeking comments regarding NIH's support of biomedical research, including peer review, with "the goal of examining the current system to optimize its efficiency and effectiveness." This request is related to the recently-announced formation of the Peer Review Working Group of the Advisory Committee to the NIH Director, which has been asked "to gather information from the external community and explore possible enhancements to all aspects of the system used by NIH to support biomedical and behavioral science, including the two-tiered review process."

ASH will be reviewing this issue and submitting comments in response to NIH's Request for Information. If you have any particular concerns or comments on this issue, please contact ASH Research Advocacy Manager Tracy Becker at tbecker@hematology.org.

If you have any questions or need additional information about any of the items in this Update, please contact the ASH Government Relations and Practice office at 202-776-0544 or via e-mail at grassroots@hematology.org.