American Society of Hematology

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Headlines from Washington September-October 2007

2007-09-01

CMS Finalizes National Coverage Policy for ESAs

The Centers for Medicare and Medicaid Services (CMS) finalized its national coverage determination (NCD) for non-renal uses of ESAs on July 30.

The new policy does not include myelodysplastic syndromes (MDS), which means that ESA treatment for Medicare beneficiaries with MDS is covered without any conditions or limitations. Local Medicare carriers may continue to make local coverage decisions that are not included in this national coverage decision. ASH will continue to monitor this situation and work with local carriers as issues arise.

The NCD includes several limitations for patients undergoing ESA treatment for the anemia secondary to myelosuppressive anticancer chemotherapy in solid tumors, multiple myeloma, lymphoma, and lymphocytic leukemia. As this issue of The Hematologist went to press, ASH was continuing to weigh in with CMS about concerns that the policy does not allow the hemoglobin level to go above 10g/dL without stopping therapy. ASH has recommended a policy that allows a target range between 10-12g/dL.

ASH was deeply concerned with CMS’s proposed coverage decision that was released in May because the proposal was not supported by scientific data and was in conflict with expert analysis. ASH submitted comments and met with CMS officials as well as testified before FDA’s Oncology Drug Advisory Committee and met with FDA officials to discuss concerns and recommendations. ASH and the American Society of Clinical Oncology (ASCO) are scheduled to jointly publish an update of our guidelines on the appropriate use of Epo in September.

During the ASH annual meeting in December, the Practice Forum will address this issue. The Practice Forum, "Evidence, Safety, and Clinical Decision Making: The Case of ESAs," is scheduled for Saturday, December 8, at 6:00 p.m.

FY 2008 Budget Process: ASH Continues to Advocate for Larger Increase for NIH

As congressional leaders maintain their intention to adjourn for the year by late October, Congress is continuing the process of drafting the bills that will fund federal departments, agencies, and programs for fiscal year (FY) 2008.

Over the summer, the House and Senate Appropriations Committees proposed funding levels for various federal programs and agencies, including the National Institutes of Health (NIH). The House version of the FY 2008 Labor-HHS spending bill provides a net increase of $549 million (1.9 percent) over FY 2007 for NIH. Meanwhile, the net increase proposed by the Senate for the NIH budget in its draft bill is $799 million (2.8 percent) over FY 2007. As this issue of The Hematologist went to press, President Bush indicated his intentions to veto the bill due to its cost, and it appeared that full Senate passage may not come until October. Many in Washington are expecting that agreement between the House and Senate is unlikely, which would necessitate an omnibus spending bill.

It is important to note that both the Senate and the House proposed funding levels for NIH in FY 2008 essentially represent a cut in NIH funding, since the small increases they provided do not keep pace with the projected 3.7 percent increase in biomedical inflation for 2008.

ASH will continue its advocacy efforts supporting increases for NIH on Capitol Hill throughout the remainder of the FY 2008 budget debate. With a very tight year expected for the entire federal budget and many domestic programs facing cuts or minimal increases, significant grassroots support for NIH funding is critical to gain any further traction for increasing NIH funding in the budget process.

President Vetoes Stem Cell Research Bill; Congressional Leaders Continue the Fight to Expand Federally Funded Stem Cell Research

As expected, President Bush vetoed the Stem Cell Research Enhancement Act (S. 5) in late June. While congressional leaders hope to attempt to override the President’s veto, it is unlikely that the bill has the two-thirds majority support in either the Senate or the House necessary to override the veto.

Additionally, in response to President Bush’s veto of the bill, Senate Labor-HHS Appropriations Subcommittee Chairman Tom Harkin (D-IA) and Subcommittee Ranking Member Arlen Specter (R-PA) have included a provision in the Senate version of the FY 2008 Labor-HHS Appropriations bill that would essentially overturn the President’s recent decision and make more embryonic stem cell lines available for federal funding. The language inserted by Senators Harkin and Specter, the chief Senate sponsors of the Stem Cell Research Enhancement Act, would allow federal research funding on stem cell lines derived prior to June 15, 2007; current Bush Administration policy allows for federal funds to be used only for research on embryonic stem cell lines derived prior to August 9, 2001.

Because similar language was not included in the House version of the FY 2008 Labor-HHS Appropriations bill, it remains unclear as to whether the stem cell language will be included in a final version of the bill that would be submitted to the President.

Medicare Agency Proposes Physician Fee Schedule for 2008; Physicians Face 9.9 Percent Cut Unless Congress Acts

CMS published its Proposed 2008 Medicare Physician Fee Schedule Rule on July 12, and as expected the Agency proposed reducing physician payments by 9.9 percent beginning January 1, 2008.

ASH has been 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. However, even with congressional action, the best scenarios would be a .5 percent increase or a freeze in the 2007 conversion factor in 2008.

ASH has developed a detailed summary of the rule, including information about proposals to report anemia quality indicators, compendia for medically accepted indications for off-label drug uses, the 2008 Physician Quality Reporting Initiative, payment for intravenous immune globulin (IVIG), and Average Sales Price issues, etc. The final rule will be published around November 1 and will go into effect on or after January 1, 2008.