Editor: Joseph S. Bailes, MD, Chair, ASCO Government Relations Council

ASCO Submits Comments to CMS on Fee Schedule
ASCO submitted comments to CMS, addressing concerns about cuts to oncology services in the proposed 2010 Physician Fee Schedule.

ASCO Submits Comments on Medicare Hospital Payment Rates
ASCO submitted comments August 28 on CMS’s proposed changes to the Medicare Hospital Outpatient Prospective Payment System and 2010 Payment Rates.

ASCO Provides Analysis of FDA Rule on Expanded Access
On August 13, FDA published two final rules related to patient access to investigational drugs. ASCO has developed a summary and analysis of the rules.

New NIH Director Outlines Priorities for Agency
Newly appointed NIH Director Francis S. Collins, MD, outlines his top priorities for the Agency over the coming years, with maintaining and increasing funding levels at the top of the list.

Upcoming Symposium To Educate Practices on Selecting and Using EHRs
ASCO is hosting a symposium to help oncology practices select and use the EHR system that is right for them.

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ASCO Submits Comments to CMS on Physician Fee Schedule

ASCO submitted comments to the Centers for Medicare & Medicaid Services (CMS), addressing concerns about cuts to oncology services in the proposed 2010 Physician Fee Schedule.

In its comments, ASCO states that:

• CMS should not use flawed data from AMA’s Physician Practice Information Survey to determine practice expense relative value units for oncology practices. Data from this methodologically flawed survey will reduce payments for chemotherapy administration by more than 20 percent. This would make it difficult for oncologists to continue providing office-based chemotherapy and adversely affect care for Medicare beneficiaries with cancer.
• CMS also should not reduce the malpractice relative value units assigned to chemotherapy administration codes, as proposed.
• CMS should remove physician-administered drugs from the sustainable growth rate methodology, both prospectively and retroactively.
• CMS should not eliminate consultation codes. This would disadvantage physicians, who must provide significant additional documentation for a consultation and should receive additional payment for this work.

ASCO also emphasizes that reducing payments for chemotherapy administration services would directly conflict with Congressional intent as outlined in the Medicare Modernization Act of 2003.

ASCO also has developed a fact sheet outlining how proposed Medicare cuts threaten access to cancer care in the United States. Information on the fact sheet, which is a downloadable, printable PDF file, includes an ASCO poll showing that most practicing oncologists would have to limit the care they provide to patients if the proposed cuts go into effect, as well as stories from specific practices. This fact sheet, and more information about the Medicare fee schedule, is available online at www.asco.org/policypriorities.

For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department at 571-483-1670 or publicpolicy@asco.org.

ASCO Submits Comments on Medicare Hospital Payment Rates

ASCO submitted comments August 28 on CMS’s proposed changes to the Medicare Hospital Outpatient Prospective Payment System and 2010 Payment Rates. In its comments, ASCO strongly advises CMS to set reimbursement for separately paid drugs and biological at ASP plus 6 percent.

ASCO disagrees with CMS’s decision to package all contrast agents and diagnostic radiopharmaceuticals, stating that packaging should never include products that are part of anti-cancer therapeutic regimens. ASCO supports the CMS proposal to reimburse for the use of therapeutic radiopharmaceuticals using ASP information.

To access the full comments, visit ASCO's web site. If you have any questions, contact ASCO’s Cancer Policy & Clinical Affairs Department at 571-485-1670 or publicpolicy@asco.org.


ASCO Provides Analysis of FDA Rule on Expanded Access

On August 13, the Food and Drug Administration (FDA) published two final rules related to patient access to investigational drugs. ASCO has developed a summary and analysis of the rules available on the ASCO Web site. FDA has posted both rules, as well as some preliminary descriptive materials, on the FDA Web site.

ASCO is pleased that FDA has finalized the rules, which provide greater clarification of the process for obtaining access to and charging for investigational drugs. The clarification provided within the two rules is only a first step toward creating a more navigable process for physicians and their patients. Education will be key, and the Agency has expressed intent to develop additional educational materials and clarifying information.

ASCO is examining the new process carefully and will create educational materials to assist physicians in understanding the process and FDA’s requirements – particularly for health care providers who are unfamiliar with the administrative and regulatory issues associated with investigational agents. ASCO also will post information for patients on Cancer.net. As ASCO identifies any gaps and ambiguities in FDA’s description of the process, the Society will work with the FDA to address these issues and to communicate this information to the oncology community.

ASCO is particularly interested in hearing from physicians and nurses who have experience working with companies to secure access to investigational drugs and submitting requests for expanded access to the FDA – particularly for individuals or small patient groups. Your insights on the process will help ensure that the educational materials and resources that the Society develops will address the most common questions, barriers and complications.

For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department at 571-483-1670 or researchpolicy@asco.org.


New NIH Director Outlines Priorities for Agency

Newly appointed NIH Director Francis S. Collins, MD, is outlining his top priorities for the Agency over the coming years. At the top of the list is ensuring that the Agency maintains and increases funding levels in order to meet ongoing scientific research needs.

NIH received an increase in funding this year as well as additional resources allocated through the economic stimulus package signed by President Obama earlier this year. President Obama also included $31.01 billion in funding for NIH in his FY 2010 budget request.

Other priority areas for NIH under Dr. Collins include:

• Increased research on applied technology, such as nanotechnology and stem cell research, and how it relates to fundamental biology.
• Increased focus on translational research, specifically efforts to transform scientific discoveries from laboratory, clinical, or population studies into clinical applications to reduce cancer incidence, morbidity, and mortality.
• Developing NIH’s role in health care reform, including comparative effectiveness research, as well as pharmacogenomics, or the practice of optimizing drug therapies according the patient’s genotype.
• Focusing on global health issues.

Upcoming Symposium To Educate Practices on Selecting and Using EHRs

With the American Recovery and Reinvestment Act (ARRA) signed into law, now is the time to get the latest information about the stimulus package as it relates to oncology. The 2009 ASCO EHR Symposium: Harnessing the EHR, From Incentives to Sustainability, to be held October 6-7 in San Francisco, offers oncology practices the resources and information they need to make informed decisions on selecting, adopting, and using EHR technologies and on understanding how to maximize stimulus payment under ARRA.
Meeting highlights will include:

• Three plenary sessions featuring notable speakers.
• Six breakout sessions on topics such as return on investment and cost issues, using EHRs as a quality tool, policy and procedures for EHR practices, and personal health records.
• Oncology-specific EHR vendor demonstrations.
• The release of a white paper and technical specifications document with the functional requirements that will help shape oncology EHR development.

Visit the ASCO EHR Symposium Web page for more details about the program, registration, and housing. Early registration ends September 9, so act now.

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News and Notes
Participate in QOPI and the QOPI Certification Program
ASCO’s QOPI® Certification Program will certify oncology practices that achieve rigorous, oncologist-defined standards for high-quality cancer care. Practices that participate in the fall 2009 QOPI data collection process will be the first eligible to receive certification in early 2010. Visit www.asco.org/qopi or email qopi@asco.org for more information on QOPI or the QOPI Certification Program.

New Edition of Practical Tips for the Oncology Practice
Practical Tips for the Oncology Practice, 5th Edition is the premier resource for oncology practices. It provides guidelines on coding, billing and coverage of oncology-related services and outlines the laws and regulations that affect an oncology practice. Practical Tips contains explanations of many Medicare initiatives and provides excerpts from Medicare manuals. This is a must-have resource for oncology practices. Order yours today: visit www.asco.org/practicaltips or call ASCO’s Customer Service hotline at 888-273-3508.

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 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.