2010-09-01

HHS Announces Final Rules to Expand Use of Electronic Health Records

The U.S. Department of Health and Human Services (HHS) recently announced final rules aimed at increasing safety and reducing health-care costs through expanded use of electronic health records (EHRs). Under a provision included in the American Recovery and Reinvestment Act of 2009 (ARRA), eligible health-care professionals and hospitals can qualify for Medicare and Medicaid incentive payments when they adopt certified EHR technology and use it to achieve specified objectives. A final rule issued on July 13 by the Centers for Medicare and Medicaid Services (CMS) defines the minimum requirements (or “meaningful use” objectives) that providers must meet through their use of certified EHR technology in order to qualify for incentive payments.

CMS anticipates that enrollment in the EHR incentives program will begin in January 2011, with the first payments to eligible professionals and hospitals expected around May 2011. For more information, please read Dr. Larry Solberg’s article on page 14 in the July/August issue of The Hematologist.

CMS Releases Proposed 2010 Regulations Affecting Physician Payment

Earlier this summer, the Centers for Medicare and Medicaid Services (CMS) released proposed rules for the Medicare Physician Fee Schedule (MPFS) and the Hospital Outpatient Prospective Payment System (OPPS). The proposed MPFS would provide a 6.1 percent cut for physician payment in 2011 based on the sustainable growth rate (SGR). This reduction would be in addition to the 23 percent reduction that will occur on December 1, 2010, if not prevented by new legislation. The proposed rule would cut physician payments further by some rescaling of the fee schedule. ASH strongly opposes these proposed cuts and will continue to advocate to Congress and CMS the need to provide appropriate physician reimbursement and find a long-term solution to the flawed payment formula.

The OPPS proposed rule will update policies and payment rates for the more than 4,000 hospitals that provide hospital outpatient services to Medicare beneficiaries and for the approximately 5,000 Medicare-participating Ambulatory Surgery Centers. In addition, OPPS will implement provisions of the Patient Protection and Affordable Care Act (PPACA). CMS is proposing a 2.15 percent increase for hospitals that successfully reported CMS designated quality measures in 2010. Detailed analyses of these proposed rules may be found at www.hematology.org/Practice.

FY 2011 NIH Funding Process Moves Forward

The Senate Appropriations Committee approved its draft fiscal year (FY) 2011 Labor, Health and Human Services (HHS), Education and Related Agencies Appropriations bill on July 29. The Committee-approved bill, which must still be voted on by the full Senate, recommends just over $32 billion for NIH — approximately $1 billion (3.2 percent) over the final FY 2010 funding levels that were enacted in December of last year. This falls short of the $35 billion in funding ASH and the biomedical research community have advocated for NIH in FY 2011.

Meanwhile, the House Labor-HHS Appropriations Subcommittee approved its version of the FY 2011 Labor-HHS bill on July 15. As with the Senate bill, the House Subcommittee bill recommends that NIH be funded at just over $32 billion. However, neither the House Appropriations Committee nor the full U.S. House of Representatives were able to consider the bill prior to adjourning for the month-long August district work period.

With both the Senate and House adjourned until the week of September 13, it remains unlikely that the appropriations process will be completed by the start of the new fiscal year on October 1. As a result, Congress would have to implement what is known as a continuing resolution that would simply fund the government at current levels to avoid a government shut-down.

ASH will continue its advocacy efforts supporting increases for NIH on Capitol Hill throughout the remainder of the FY 2011 budget debate. The Society encourages all members to visit the ASH Advocacy Center at www.hematology.org/takeactionto take action to support increased funding for NIH. 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.

FDA Announces Reorganization of the Office of Oncology Drug Products

As part of recent organizational changes within the Food and Drug Administration (FDA), the Office of Oncology Drug Products (OODP) is planning a reorganization that is expected to take effect in 2011. The OODP, which currently comprises three divisions, will change its name to the Office of Hematology and Oncology Products (OHOP) and create a new structure with four divisions:

• The Division of Hematology Products (DHP)
• The Division of Hematology Oncology Toxicology (DHOT)
• The Division of Oncology Products 1 (DOP 1)
• The Division of Oncology Products 2 (DOP 2)

The Oncology Program, which coordinates oncology activities across FDA Centers and with the National Cancer Institute (NCI) and other cancer-related organizations, will remain in the main Office of Hematology and Oncology Products.

As a result of the reorganization, review of biologic and drug products will be integrated within each review division; review staff within the two divisions of oncology products will specialize in specific oncologic diseases (e.g., breast cancer, gastrointestinal cancer, melanoma); and there will be a distinct division, DHOT, dedicated to reviewing the nonclinical pharmacology and toxicology of oncology products.

NIH Announces Availability of Educational Loan Repayment Programs

The National Institutes of Health (NIH) recently announced the continued availability of educational loan repayment through its extramural Loan Repayment Programs (LRPs). The NIH LRPs provide promising researchers and scientists the opportunity to pursue research careers by repaying up to $35,000 of their qualified student loan debt each year. The application period for new and renewal extramural applicants is September 1 through December 1, 2010.

Applicants accepted into the programs will engage in NIH mission-relevant research for at least two years, during which time a minimum of 50 percent of their work hours (not less than 20 hours based on a 40-hour work week) must be applied toward their NIH research activities. The NIH extramural LRPs are intended to increase the recruitment and retention of research investigators in the following areas of research: clinical, pediatric, health disparities, and contraception/infertility. Each of the LRPs has specific eligibility requirements and funding set-asides. Details of the NIH LRPs may be found on the LRP website at www.lrp.nih.gov. 

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