Senate Passes the Genetic Information Nondiscrimination Act
On April 24, the Senate passed the Genetic Information Nondiscrimination Act (GINA) by a vote of 95-0.
The GINA legislation provides important federal protections against the misuse of genetic information by employers and health insurers. Specifically, the law will:
- Prohibit the use of genetic information to deny employment or insurance coverage.
- Ensure that genetic test results are kept private.
- Prevent an insurer from basing eligibility or premiums on genetic information.
The bill will go before the House of Representatives, where House members are expected to vote on it sometime this week. President Bush has indicated that he will sign the bill in to law if it passes both chambers of Congress.
ASCO has supported the passage of the GINA bill as a member of the Coalition for Genetic Fairness, a group founded in 2000 to address the growing concern surrounding the misuse of genetic information in insurance and employment decisions.
ASCO will monitor GINA’s progress and continue to keep members informed as the bill moves forward. For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department, at 703-299-1050 or publicpolicy@asco.org.
ASCO Sends Letter Supporting the Reagan-Udall Foundation
ASCO, along with more than 60 members of the biomedical research, patient and advocacy communities, sent a letter to the House of Representatives Subcommittee on Agriculture, Rural Development, Food and Drug Administration (FDA) and Related Agencies in support of the Reagan-Udall Foundation, which will take critical steps to strengthen FDA’s scientific infrastructure.
The purpose of the Reagan-Udall Foundation is to establish a public/private partnership to modernize medical product development, accelerate innovation, and enhance product safety. In addition, the Foundation could create opportunities for career training that are not readily available today, such as a fellowship program, or aid in post-market surveillance efforts. The Foundation is not responsible for additional testing of any specific FDA-regulated product and will not supplant the rigors of the approval process.
For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department, at 703-299-1050 or publicpolicy@asco.org.
Congress Focuses on FDA Oversight of Drugs Manufactured Abroad
On April 24, an FDA official testified before the Senate Education, Labor, Health and Pensions (HELP) Committee, reporting that the increasingly large number of pharmaceutical ingredients manufactured abroad makes it nearly impossible for the Agency to ensure the safety of all drugs sold in the United States.
Scrutiny of FDA’s ability to inspect foreign drug-manufacturing plants has increased after Heparin, a blood-thinning drug manufactured in China, was found to be contaminated and may have been a factor in up to 81 deaths. Congress has also focused on the safety of food produced overseas.
House Energy and Commerce Chairman John Dingell (D-MI), has proposed draft legislation that would assess user fees for all domestic and foreign drug and food producers. The legislation would require inspection of foreign drug-manufacturing plants every two years, and new rules would govern how imported food and medical products could enter the United States.
On April 22, the Government Accountability Office (GAO) released new data that found the FY 2009 FDA budget for foreign inspections is inadequate.
ASCO will continue to monitor this issue. For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department at 703-299-1050 or researchpolicy@asco.org.
CMS Announces Bonus Payment and Reporting Changes to 2008 PQRI Program
The Centers for Medicare and Medicaid Services (CMS) recently announced changes to the Physician Quality Reporting Initiative (PQRI) program for 2008, in accordance with the Medicare, Medicaid, and SCHIP Extension Act of 2007.
The following changes were made to the PQRI program:
- Providers who meet criteria for satisfactory submission of quality measures data for services furnished during 2008 calendar year will earn an incentive payment of 1.5% of their total allowed charges for Physician Fee Schedule-covered professional services during that period. CMS has removed the ‘cap’ that can limit bonus payments to an amount less than 1.5% for 2007, so all participants who meet the criteria will earn the 1.5% bonus payment.
- CMS established an alternative reporting period, from July 1 to December 31, for providers who report on one of four new measures groups, including diabetes, preventive care, chronic kidney disease, and end-stage renal disease.
- Registries may be used for reporting PQRI measures in 2008 (individual measures or measure groups). CMS has not yet released complete details of registry requirements for PQRI.
More information about PQRI changes for 2008 is available online. CMS stated that data and payments for 2007 PQRI participation should be available to practices in mid-July.
CPC Leadership Meets with Congressional Members
On April 17, ASCO Clinical Practice Committee (CPC) leadership came to Washington, DC, to meet with Members of Congress and their staffs to provide information on issues affecting quality cancer care.
Specifically, the CPC leadership spoke to Congressional representatives on the following issues:
- The need for a long-term fix to the physician payment cuts, which are set to go into effect July 1.
- The Comprehensive Cancer Care Improvement Act (S. 2790 and H.R. 1078), which would create a Medicare service for treatment planning and summaries.
- H.R. 3011, which would ensure adequate payment for underwater drugs.
- Institutes of Health (NIH), to keep pace with inflation.
For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department, at 703-299-1050 or publicpolicy@asco.org.
ASCO Co-sponsors Anticancer Agent Development Workshop
ASCO is co-sponsoring the 2008 Accelerating Anticancer Agent Development and Validation Workshop June 18-20 in Bethesda, MD.
The workshop is designed to bring together leaders in clinical and translational cancer research from academia, industry, the National Cancer Institute (NCI), and FDA to help these investigators understand and improve the process of cancer drug development.
Additional sponsors include FDA, NCI, the American Association for Cancer Research (AACR), and the Duke Comprehensive Cancer Center.
More information about the 2008 Accelerating Anticancer Agent Development and Validation Workshop – including a program schedule, attendance criteria, faculty list, and logistic details – is available at www.acceleratingworkshop.org.
House Health Subcommittee Advances Conquer Childhood Cancer Act
On April 23, the Health Subcommittee of the House Energy and Commerce Committee voted to advance H.R.1553, the Conquer Childhood Cancer Act of 2007.
The bill, sponsored by Rep. Deborah Pryce (R-OH), would: ensure patients and families have access to the current treatments and information on pediatric cancer, advance medical research into pediatric cancer, establish a national childhood cancer database, and promote public awareness of pediatric cancers. It would authorize $30 million per year for FY 2009 through 2013. The bill currently has 213 co-sponsors in the House.
S. 911, the Senate companion legislation, introduced by Sen. Jack Reed (D-RI), currently has 60 co-sponsors. The full Senate has not yet voted on it.
For more information, contact ASCO’s Cancer Policy and Clinical Affairs Department, at 703-219-1050 or publicpolicy@asco.org.
Sen. Clinton Introduces Childhood Cancer Survivorship Act
On April 17, Sen. Hillary Clinton (D-NY) introduced S. 2877, the Pediatric, Adolescent, and Young Adult Cancer Survivorship Research and Quality of Life Act of 2007.
The bill, known as the Childhood Cancer Survivorship Act, would lead to improved health for the growing number of survivors of childhood cancers by improving and expanding the delivery of medical and psychosocial care to survivors of childhood cancer.
Specifically, the legislation would establish:
- NIH cancer survivorship programs, including grants to address health disparities in childhood cancer survivorship.
- Clinics for comprehensive long-term follow-up services for survivors of childhood cancer.
- Grants to improve access to care for survivors of childhood cancer.
- Centers for Disease Control and Prevention cancer control programs aimed to provide guidance to states and encourage them to improve systems of care for survivors of childhood cancer.
The House version of this bill (H.R.4450) was introduced by Reps. Hilda Solis (D-CA) and Mary Bono Mack (R-CA) in December. It currently has 14 co-sponsors.
The Alliance for Childhood Cancer, of which ASCO is a member, strongly supports this legislation. ASCO thanks Sen. Clinton for addressing the important issue and introducing S. 2877.
For more information, contact ASCO’s Cancer Policy and Clinical Affairs at 703-299-1050 or publicpolicy@asco.org.
News and Notes
ASCO Encourages Members to Share their Experiences about Flat Funding to NIH
ASCO is encouraging members with past or current experience applying for NIH funding to fill out a new survey that the Federal Advocates Policy Partnership Research Working Group developed to encourage Congress to increase funding for the NIH. Please complete the survey by Friday, May 30, and contact Monica Ruiz with any questions at monica.ruiz@amfar.org.
Reimbursement Session at the ASCO Annual Meeting
A “Forum on Reimbursement” special session will take place at 2008 ASCO Annual Meeting, on Monday, June 2, from 9:45 to 11:00 a.m. in the Arie Crown theater. For more information, contact Julia Tomkins at Julia.Tomkins@asco.org.
New ESA Instruction Sheet Available on ASCO Web site
An instruction sheet on reporting hematocrit/hemoglobin in conjunction with claims for erythropoiesis-stimulating agents (ESAs) is available on ASCO’s Web site.
Join ASCO's Advocacy Network
Advocacy is most effective when Members of Congress and government agencies hear from you, their constituents. By participating in ASCO's Advocacy Network, you will have the opportunity to develop ongoing relationships with your legislators while helping ASCO raise awareness on important cancer issues. To join the Advocacy Network, visit ASCO's Grassroots Action Center.
ASCO Extends Resources to Practice Administrators
ASCO encourages members whose practice administrators are interested in receiving Cancer Policy Today to forward their administrator's contact information to practice@asco.org.
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