October 2007 Practice Update (part two)

ESA Update: ASH Works With Local Carriers on MDS Coverage
Local Medicare Carriers are developing ESA coverage policies for MDS patients. The draft policies are appearing in several states, and ASH continues to monitor the situation, comment on the proposals, and provide written comments with information and recommendations. Currently, Trailblazer has developed a policy that will cover Delaware, Maryland, Texas, and Virginia and Noridian has a proposed policy that will cover Arizona, Montana, North Dakota, South Dakota, Utah, and Wyoming.

In preparation for action in additional regions, ASH will be posting a "model policy" to the ASH Web site in the next few days. The policy will highlight ASH’s key recommendations to local carriers regarding indications for ESA treatment for patients with MDS. We encourage you to refer to this policy when addressing local issues in your area. Please contact ASH at (grassroots@hematology.org) with any questions or concerns you have about coverage in your area and assistance for working with local carriers.

ASH-ASCO Practice Guidelines to be Released 10/22; ASH Continues Fight to Reopen National Coverage Decision
The ASH-ASCO Clinical Practice Guideline Update on the Use of Epoetin and Darbepoetin will be pre-published online by ASH’s scientific journal, Blood, on Monday, October 22.

ASH believes the current Medicare coverage policy reflects a misinterpretation of the evidence. ASH will share the updated guidelines with the Centers for Medicare and Medicaid Services (CMS) and is hopeful that this will result in CMS reopening its coverage policy. In the meantime, Representatives Anna Eshoo (D-CA) and Mike Rogers (R-MI) have introduced a bill (H.J. Res. 54) that would reverse the CMS decision to limit Medicare coverage of ESA therapy for cancer patients. It is anticipated that Senator Baucus (D-MT) will introduce a similar bill in the Senate on this issue. No votes have been scheduled yet for either piece of legislation.

It would be precedent-setting to use the legislature to overrule regulatory agencies; however, the threat of legislation alone could also be a useful tactic to encourage CMS to reopen this decision. Next week ASH will present at a Congressional briefing for all health staff about the guidelines and the Society’s concerns with the coverage policy.

CMS Issues Final Decision Memorandum on Proposed Revisions to Medicare Clinical Research Policy; ASH Recommendations Incorporated and Concerns Addressed
On October 17 CMS issued a final policy on proposed revisions to rules governing Medicare coverage of services provided to beneficiaries enrolled in clinical research studies that incorporates a number of recommendations and concerns ASH voiced throughout the reconsideration process. The final policy maintains the proposed revisions contained in CMS’s July 9 final Decision Memorandum on the policy and negates all of the proposals contained in its reconsideration of proposed revisions to the Medicare National Clinical Trial Policy.

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 proposed revisions to this policy, and ASH submitted comments expressing concern with a number of the proposed revisions. ASH's original comments to CMS in May expressed 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.

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

However, after issuing the July 9 Decision Memorandum, CMS reopened the Clinical Trial Policy for a second reconsideration. ASH's comments on the most recent proposed revisions focused on concerns about proposed new requirements for public release of research study information and self-certification requirements.

A copy of the final Decision Memorandum can be found on the CMS Web site, along with a Q & A on the Final Decision for Clinical Research Policy.

Take Action: Urge Congress to Stop Scheduled Medicare Physician Pay Cuts
Absent Congressional action, physicians face Medicare payment cuts of 9.9 percent beginning in January 2008. Although a provision to replace the cut with a 0.5 percent payment increase was originally included in the children's health bill (H.R. 976), it was stripped from the legislation. Visit the ASH Advocacy Center and support ASH’s efforts to help Congress find a legislative vehicle that can prevent these cuts before the end of the year.

ASH Encourages CMS to Expand Drug Coverage for Medicare Part D
There is a growing list of oral chemotherapy medications that will benefit patients and that currently may be restricted under Medicare Part D. Medicare Part D drug coverage permits reimbursement for off-label drug use only through compendia citations, while Medicare Part B is more expansive and also allows coverage through the use of peer-reviewed literature. ASH has written CMS encouraging them to make their coverage policies under Part B and Part D consistent by expanding the options for drug coverage in Part D.

Medicare Updates Off-Label Coverage
CMS has updated the list of peer-reviewed journals that Medicare contractor medical directors may use as references of off-label uses of anticancer drugs. An off-label use of a drug in anticancer chemotherapeutic regimen must be covered by Medicare Part B if the use is supported by peer-reviewed articles published in certain journals. Individual Medicare carriers have authority to evaluate the literature and determine whether it supports the off-label use. Physicians may point contractor medical directors to peer-reviewed articles in discussing coverage. As of October 22, CMS will accept the following journals in addition to the original list: Annals of Oncology; Biology of Blood and Marrow Transplantation; Bone Marrow Transplantation; Gynecologic Oncology; Clinical Cancer Research; International Journal of Radiation, Oncology, Biology, Physics; Journal of NCCN; Radiation Oncology; Annals of Surgical Oncology; and Journal of Urology; Lancet Oncology.

National Quality Forum (NQF) Requests Hematology/Oncology Performance Measures
The NQF has requested clinician level hematology/oncology care measures for review. ASH will submit the four hematology measures developed for PQRI. Some of these measures are also used in ASH’s Performance Improvement Modules, which are web-based self-evaluation tools used to earn credit for ABIM Maintenance of Certification.

To date, the NQF has endorsed performance measures for cancer care at the institutional level (e.g., hospitals, health plans) but not at the individual clinician level. The NQF is responsible for identifying and endorsing measures for public accountability and quality improvement that will provide meaningful information to consumers, purchasers, providers, health-care professionals, quality improvement organizations, and researchers. Funding for this project has been provided by CMS.

Survey to Assess Interest in an ASH Publication for Practitioners
Practitioners will be invited by e-mail to participate in a short online survey to evaluate how effectively Blood and other ASH publications are addressing practitioner professional interests and practice needs. The survey will also evaluate participant interest in seeing a new ASH publication focused specifically on practitioners. The survey, being conducted under the auspices of ASH’s Journals Committee, will be available online beginning October 26, 2007; the link to survey will be posted in the e-mail invitation. The cut-off date for responses is November 9, 2007, and all participants completing the survey will be enrolled automatically in a drawing for an Apple 16 GB iPod Touch, with the winner to be announced in early December 2007.