2009-09-01

ASH Continues to Advocate for Larger Increase for NIH

The House of Representatives has approved its version of the fiscal year (FY) 2010 bill funding the National Institutes of Health (NIH). The House bill includes $30.967 billion for NIH, an increase of $500 million over the President’s request and $942 million over FY 2009. Additionally, as this issue of The Hematologist went to press, the Senate Appropriations Committee had approved its version of the bill, which included funding for NIH equal to the President’s request, but a time frame for a vote by the full Senate had not yet been announced. Spending bills need to be passed by October 1, which marks the beginning of the federal fiscal year. ASH has supported an increase of at least 7 percent for NIH. For the latest information concerning NIH funding, including use of funding provided by the American Recovery and Reinvestment Act (ARRA), please visit the ASH Website at www.hematology.org.

Obama Administration Releases Final Guidelines on Human Stem Cell Research

The Obama administration released final guidelines governing human embryonic stem cell (hESC) research to implement the President’s March 9 Executive Order that will allow research involving many of the approximately 700 existing cell lines to be eligible for federal funding. The guidelines establish policy and procedures under which the NIH will fund extramural stem cell research. The previous policy implemented by President George W. Bush had allowed federal dollars to pay for some stem cell research, but only if studies were performed on the 21 cell lines that had existed prior to August 2001.

The final guidelines reflect several changes in the rules the administration proposed in April. These changes were made in response to criticism by the scientific community, including ASH, that was directed at new restrictions that might have unintended consequences. For example, they modified the rule requiring that donors of fertilized eggs sign extensive consent forms, which would have made even some of the stem cell lines approved by the Bush administration ineligible for further funding. The final guidelines stipulate that human stem cell lines created before July 7, 2009, may seek review by the Working Group of the Advisory Committee to the Director (ACD). The ACD, which is a chartered Federal Advisory Committee Act committee, will advise NIH on whether the core ethical principles and procedures used in the process for obtaining informed consent for the donation of the embryo were such that the cell line should be eligible for NIH funding. The crucial test will be whether the embryos used to create the stem cell lines were created solely for reproductive purposes and whether donors freely consented to their use in research.

Francis Collins Confirmed as NIH Director

The U.S. Senate has unanimously confirmed Francis Collins, MD, PhD, as director of the National Institutes of Health (NIH). Dr. Collins is the former director of the National Human Genome Research Institute (NHGRI) at NIH, where he led the effort to complete the Human Genome Project. Dr. Collins left his position as director of NHGRI in 2008 to explore other writing and professional opportunities but has continued at NHGRI’s Division of Intramural Research as a special volunteer.

Some of Dr. Collins’ early research focused on sickle cell disease, thalassemia, and the hereditary persistence of fetal hemoglobin. His research has also led to the identification of the genes responsible for the M4 type of adult acute leukemia.

CMS Proposes Payment and Policy Changes for Physicians for FY 2010

The Centers for Medicare & Medicaid Services (CMS) released its proposed Medicare Physician Fee Schedule for 2010. Once again, physicians are facing a significant reduction in Medicare payment unless Congress acts. CMS projects a negative update of -21.5 percent for the proposed 2010 Medicare Physician Fee Schedule based on the application of the Sustainable Growth Rate (SGR) formula. A complete summary of the proposed rule and analysis of its impact on hematologists, along with ASH’s comments to CMS, may be found on the ASH Web site. Specific areas of concern include the overall impact on hematology/oncology, changes to the SGR, elimination of consultation codes, and changes to physician quality programs. The final rule is expected to be published later this fall, and, unless otherwise specified, the new payment rates and policies will apply to services furnished to Medicare beneficiaries on or after January 1, 2010.

CMS Proposes 2010 Rule for HOPPS

CMS has proposed its rule for the hospital outpatient prospective payment system (HOPPS) for 2010. CMS projects that overall CY 2010 payments to the more than 4,000 hospitals subject to HOPPS will be $31.5 billon. This reflects an increase in the hospital market basket of 2.1 percent. Hospitals are required to participate in a quality reporting program in order to be eligible for the full increase. A complete summary of the proposed rule along with ASH’s comments to CMS may be found on the ASH Web site. Specific areas of interest to hematology include payment for hematologic-related services, classification of allogeneic bone marrow transplant procedures, quality reporting, and payment for drugs and radiopharmaceuticals.

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