August 7: Senate Appropriations Committee Details Second Economic Stimulus Package, FDA Orders Label Change for ESAs, New Advances on E-Prescribing Adoption
Senate Appropriations Committee Details Second Economic Stimulus Package On July 30, the Senate Appropriations Committee released the details of a second economic stimulus package, which would provide funding on a variety of initiatives through the end of FY 2008 on September 30. This package is separate from the FY 2009 appropriations process.
The supplemental funding package totals just over $24 billion and includes $500 million for the National Institutes of Health (NIH) for grants to study cancer, Alzheimer's disease, heart disease and other diseases.
Committee Chair Robert Byrd (D-WV) has said he hopes to move the package to the Senate floor in September. The House of Representatives also is likely to consider a second economic stimulus package in September.
For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department, at 571-483-1670 or publicpolicy@asco.org.
FDA Orders Label Change for ESAs On July 31, the Food and Drug Administration (FDA) ordered Amgen and Johnson & Johnson to issue revised labels on two erythropoiesis stimulating agents (ESAs), epoetin alfa and darbepoetin.
The label changes had been under negotiation with the manufacturers, but FDA used its new authority under 2007 amendments to the Federal Food, Drug and Cosmetic Act to order safety-related label changes. The FDA has mandated the following changes to the label:
ESAs are no longer indicated for patients receiving myelosuppressive chemotherapy if the anticipated treatment outcome is cure. They remain indicated when myelosuppressive chemotherapy is intended for palliation.
ESAs should not be initiated if the patient's hemoglobin is above 10 g/dL.
Further, the label change specifies that ESA treatment should target the lowest hemoglobin concentration that will avoid transfusion, removes "...or exceeds 12 g/dL" as an upper range for ESA use, and removes language that allowed earlier initiation of ESAs, or treatment to higher hemoglobin targets, if the patient cannot tolerate anemia due to a co-morbid condition.
The companies have five days from the date of issuance to appeal or 15 days to submit a supplement containing the labeling changes.
ASCO is analyzing the extensive label changes and will provide more information in the coming days. For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department, at 571-483-1670 or publicpolicy@asco.org.
House Passes Bill That Allows FDA to Regulate Tobacco Products On July 30, after a heated debate, the House of Representatives passed H.R.1108, a bill that would give FDA authority to regulate tobacco products, by a vote of 326-102.
Tobacco-related cancers account for 30 percent of all U.S. cancer deaths. ASCO supports FDA regulation of tobacco as a major advance in reducing tobacco use in the United States.
H.R. 1108 would grant FDA the ability to regulate tobacco products, restrict advertising and marketing of tobacco products, control nicotine levels, and prescribe warning labels. The new regulatory duties would be funded by fees levied on tobacco companies.
This is the first time the House of Representatives passed legislation to give FDA this authority. The vote margin was large enough to override an expected presidential veto of the bill.
The bill faces a challenge in the Senate. The Senate companion bill, S. 625, passed out of committee on August 1, 2007. The full Senate has not yet voted on it, and no vote is currently scheduled. The Senate bill currently has 56 co-sponsors.
Contact ASCO’s Cancer Policy & Clinical Affairs Department with any questions, at 571-483-1670 or publicpolicy@asco.org.
Senators Propose Legislation To Create Comparative Effectiveness Institute On August 1, Senate Finance Committee Chair Max Baucus (D-MT) and Senate Budget Committee Chair Kent Conrad (D-ND) introduced S.3408, a bill to create a public-private comparative effectiveness research institute.
The Health Care Comparative Effectiveness Research Institute would “review evidence and produce new information on how diseases, disorders, and other health conditions can be treated to achieve the best clinical outcome for patients.” It would function as a nonprofit private entity governed by a public-private Board of Governors. The Institute would be responsible for setting national priorities and would contract with NIH, the Agency for Healthcare Research and Quality, and private entities to conduct peer-reviewed research studies that answer the most pressing questions about what works in health care.
Health policy experts have said that comparative effectiveness research is a vehicle for controlling health care costs and might produce cost savings that could help provide coverage for the uninsured. The Congressional Budget Office estimated that the United States could save up to $700 billion annually in health spending by identifying treatments that do not produce the best medical outcomes.
ASCO will update you on the bill’s progress. If you have any questions, contact ASCO’s Cancer Policy & Clinical Affairs Department at 571-483-1670 or publicpolicy@asco.org.
Congressmen Introduce Medicare Oncology Care Quality Improvement Demonstration Project Act of 2008 On August 1, Rep. Joe Crowley (D-NY) introduced H.R.6725, the Oncology Care Quality Improvement Act, which would develop a pilot program to examine how evidence-based clinical pathways implemented using electronic medical records (EMRs) can improve Medicare patient care and outcomes.
This voluntary pilot program would combine the use of treatment protocols and EMRs for at least six cancer conditions. The goal of the pilot program is to provide better quality cancer care for patients while reducing expense to the Medicare program.
Participating providers will be incentivized to reduce Medicare spending by at least 5% for these six diagnoses while increasing quality of care. Quality will be measured by adherence to evidence-based pathways. Providers that lower Medicare spending by 5% for the six cancers in the demonstration project will be paid a 5% bonus as an incentive.
The bill is cosponsored by Reps. Mike Rogers (R-MI), Lois Capps (D-CA), Phil English (R-PA), Patrick Kennedy (D-RI), Mike Thompson (D-CA), Allyson Schwartz (D-PA), and Shelley Berkley (D-NV).
If you have any questions, contact ASCO’s Cancer Policy & Clinical Affairs Department at 571-483-1670 or publicpolicy@asco.org.
FDA Strengthens Conflicts of Interest Policy On August 4, FDA issued final guidelines to limit conflicts of interest (COI) among advisory committee members.
In January, ASCO sent FDA comments in response to its draft guidance documents on the public availability of advisory committee member COI disclosures and waivers, and advisory committee voting procedures. ASCO is currently analyzing the guidelines and will provide an update once it has assessed its impact on the oncology community. For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department at 703-299-1050 or researchpolicy@asco.org.
CMS Releases Policy on Preventable Hospital-Acquired Conditions Last week, the Centers for Medicare & Medicaid Services (CMS) released the final Inpatient Prospective Payment System rule. The final rule includes three hospital-acquired conditions (HACs) for which CMS will not make higher hospital payments starting October 1: surgical site infections following certain elective procedures, extreme blood sugar derangement, and deep vein thrombosis or pulmonary embolism following total knee or hip replacement procedures. These three conditions were added to a list of eight preventable HACs that CMS identified in 2007.
The three new HACs are significantly more limited than those included in CMS’s proposed rule. In June, ASCO submitted comments to CMS that raised concern about the fact that hospitalized cancer patients may be uniquely susceptible to some of the conditions that CMS had originally proposed as preventable.
Visit CMS’s Web site for more information, or contact ASCO’s Cancer Policy & Clinical Affairs Department, at 571-483-1670 or publicpolicy@asco.org.
New Advances on E-Prescribing Adoption Medicare is starting a new incentive payment program to encourage physicians to adopt e-prescribing systems. The initiative is part of the Administration’s broader efforts to accelerate adoption of health IT and establishment of a health care system based on value.
The four-year bonus program, which will begin in 2009, is designed to streamline the prescription process and cut down on errors. The bonus breakdown for services using e-prescribing will be a 2% increase in Medicare payment in 2009 and 2010, a 1% increase in 2011 and 2012, and a 0.5% increase in 2013.
After 2013, bonuses for e-prescribing will be phased out, and doctors who have not adopted e-prescribing systems will receive a reimbursement penalty. Hardship exceptions exist for doctors who have legitimate reasons for not complying.
CMS has not addressed all the technical components of how incentives will be earned, ways to report the data, and how the agency will enforce the program. Additional updates will be provided in Cancer Policy Today as CMS releases more information.
The new e-prescribing bonuses are in addition to those paid as part of the Physician Quality Reporting Initiative (PQRI) and other Medicare reimbursements.
Recent legislation extends PQRI and provides incentive payments of 2% for reporting data on quality measures in 2009 and 2010, up from 1.5% in 2008. E-prescribing coupled with PQRI could provide a 4% bonus in 2009 and 2010. Medicare expects to save up to $156 million in avoided adverse drug events over the life of the e-prescribing program.
Despite the advantages of e-prescribing, barriers such as cost of implementation remain. CMS estimates that it will cost about $3,000 per doctor to adopt an e-prescribing system, plus the expense of training and on-going maintenance. Free e-prescribing programs are available through the National ePrescribing Patient Safety Initiative (NEPSI).
FDA To Host Workshop on Clinical Trials for Local Treatment of Breast Cancer On September 15, FDA will hold a public workshop to discuss issues associated with developing and implementing feasibility trials for local treatment of breast cancer by thermal ablation.
The public workshop, which will be held at the FDA White Oak Campus in Maryland, also will serve as a forum to discuss where thermal ablation may play a role in operative therapy, chemotherapy, and radiation therapy.
For more information, contact Binita Ashar with the Center for Devices and Radiological Health, at 240-276-3600 or Binita.Ashar@FDA.HHS.gov.
Physician Practice Information Survey ASCO, the American Medical Association and more than 70 other organizations are conducting a comprehensive multi-specialty survey of America’s physician practices.
The results will be used to positively influence national decision makers. The section of the study pertaining to your practice expenses is particularly important, and we request that you complete it accurately in its entirety.
CMS has said it will use the results of this study to help determine physician payment. The survey firm, Dmrkynetec, is contacting randomly selected physicians and practice managers to respond to the survey. All responses will remain confidential.
Dmrkynetec mailed a postcard to its entire physician sample on June 11. If you received this postcard, you have been selected to participate in the survey. If you have any questions about this survey, call Dmrkynetec toll-free at 877-816-8940 and ask to speak with an executive interviewers about the 2008 Physician Practice Information Survey.
If you would like to see if you have been selected to participate in this survey, visit the 2008 Physician Practice Information Survey Web site. If you have been selected, the Web site will provide instructions for participating in the survey. ASCO encourages those selected to participate, and your cooperation is greatly appreciated.
News and Notes
ASCO Conducting Learning Needs Assessment of Member Physicians ASCO is conducting a Needs Assessment of community practice members, focusing on learning styles, barriers to learning, access to technology, and other educational topics. This information will help ASCO more closely tailor products and meetings to members’ individual needs. You may be invited to join a focus group or to simply answer a few questions about your specific educational needs and how ASCO can help.
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.
