January 23: Supreme Court Declines to Review Abigail Alliance Case, CMS Issues Transmittals on ESAs
Supreme Court Declines to Review Abigail Alliance Case On January 14, the Supreme Court declined to review the Abigail Alliance’s claim that terminally ill patients should have the constitutional right to access experimental drugs that have not been approved by the Food & Drug Administration (FDA).
In February 2007, ASCO, the National Coalition for Cancer Survivorship (NCCS) and the Association of American Medical Colleges (AAMC), submitted an amicus brief that stated that the Abigail Alliance’s demand to provide patient access to drugs after phase I testing would pose substantial risk, not only to individual patients, but also to the entire clinical trial enterprise.
In August 2007, the Court of Appeals ruled that terminally ill patients do not have a constitutional right of access to experimental drugs that have not been approved by FDA. The Abigail Alliance appealed that decision to the Supreme Court.
ASCO will continue to urge FDA to finalize the draft regulations it issued in December 2006 to clarify expanded access programs. The regulations struck the appropriate balance to allow people with cancer access to investigational agents while preserving the research system so vital to the delivery of more effective therapies.
For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department at 703-299-1050 or publicpolicy@asco.org.
CMS Issues Transmittals on ESAs On January 16, the Centers for Medicare & Medicaid Services (CMS) posted three new transmittals regarding coverage and payment for erythropoiesis-stimulating agents (ESAs) to its web site.
The first requires that all claims submitted for ESAs include reporting of hematocrit/hemoglobin. While Medicare contractors have until April 7 to prepare their systems, physicians are required to report on hematocrit/hemoglobin as of January 1. Additionally, the transmittal implements a CMS requirement that hematocrit/hemoglobin be reported in conjunction with claims for all anti-anemia drugs, not just ESAs. CMS has also published instructional guidelines for providers on the new requirements in a Medlearn Matters article.
The second transmittal provides instructions to carriers on the implementation of the July 30, 2007 National Coverage Decision on the use of ESAs in patients with cancer. Carriers will have until April 7 to implement the instructions.
The third updates the Medicare National Coverage Determinations Manual to reflect provisions of the July 30, 2007, National Coverage Decision on the use of ESAs in patients with cancer.
In reviewing the transmittals, ASCO has identified a few areas of potential confusion. ASCO issued a letter to CMS late last week requesting clarification on the posted requirements and will keep members apprised as more information becomes available. For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department at 703-299-1050 or publicpolicy@asco.org.
Oncology Roundtable on Community Engagement in Cancer Clinical Trials The Education Network to Advance Cancer Clinical Trials (ENACCT) and the Community-Campus Partnerships for Health (CCPH) are requesting that volunteers participate in “Oncology Roundtable” teleconferences February 11 to obtain oncology researcher input on their strategic plan to enhance community engagement in Phase III cancer treatment trials. Draft strategic plan recommendations – covering all aspects of the cancer clinical trial process - will be released prior to the call.
Your input is needed on either of the one-hour teleconference offered on February 11, once in the morning (10:30 am E.S.T.), and later in the evening (6:00 pm E.S.T.). You can register online for the teleconference. If you are unable to participate but would like to receive a copy of the recommendations, complete the online response form.
Reps. Bono and Solis Introduce Childhood Cancer Survivorship Act The Alliance for Childhood Cancer, of which ASCO is a member, is rallying its membership to support The Childhood Cancer Survivorship Act (H.R. 4450), introduced in mid-December by Reps. Hilda L. Solis (D-CA) and Mary Bono (R-CA). The legislation would improve and enhance research and programs on cancer survivorship. 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.
New Smoking Cessation Codes New CPT codes for smoking and tobacco cessation counseling appear in the 2008 CPT book. These new codes: 99406 (smoking and tobacco use cessation counseling visit; intermediate, greater than 3 minutes up to 10 minutes) and 99407 (smoking and tobacco use cessation counseling visit; intensive, greater than 10 minutes), replace the Medicare temporary G-codes G0375 and G0376. These new codes are categorized as evaluation and management codes and are payable services by Medicare. The payment rates for the new codes are approximately $11.93 and $23.52, respectively. [Payment rate calculation is based on the 2008 practice expense transitional value, a geographic practice cost index (GPCI) of 1.00, and a conversion factor of $34.09.]
News and Notes National Audiocall on Adapting to Changes in Medicare Available Online ASCO's National Audiocall on Adapting to Changes in Medicare in 2008 was held January 9. The slide presentation and call materials are available on ASCO's Web site. A taped version of the call also is available; contact Julia Tomkins or Laura Cathro at 703-299-1050 for more information.
Election Period Extended for Competitive Acquisition Program An additional 2008 Competitive Acquisition Program (CAP) for Drugs and Biologicals physician election period began January 15 and will conclude February 15. More information is available at the CMS Web site.
Guideline Alerts Now Available on ASCO Web site ASCO has improved its Web capabilities with the addition of a new Journal of Clinical Oncology (JCO) alert specifically for clinical practice guideline news. To sign up, visit 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 subscribing to Cancer Policy Today to forward their administrator's contact information to practice@asco.org.
