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

ASCO Meets with CMS to Express Concern about Proposed Medicare Fee Schedule Cuts
ASCO CEO Allen Lichter, MD, and ASCO staff and counsel met with the CMS acting administrator and relevant staff to express deep concern about cuts to oncology in the proposed Medicare fee schedule and to ask CMS to abstain from using the flawed AMA data to implement the cuts.

House Committee Includes Important ASP Provision in Health Reform Legislation
The House Energy and Commerce Committee voted to include language in its health care reform legislation that would remove prompt pay discounts extended to drug wholesalers from the ASP calculation.

FY 2010 Appropriations Update
On July 30, the Senate Appropriations Committee passed a FY 2010 Labor-HHS-Education Appropriation bill, which includes $30.8 billion in funding for NIH.

FDA Approves Onsolis with Risk Evaluation and Mitigation Strategy
On July 16, the FDA approved Onsolis (fentanyl buccal soluble film) for use in certain patients with cancer to help manage breakthrough pain.

New Compliance Date Set for “Red Flags” Rule
FTC recently extended the compliance date for its “red flag” rule to November 1. This rule would require creditors and financial institutions to implement programs and policies to identify, detect, and respond to potential risks of identity theft.

NCI Requests Information on Immunotherapy Translational Opportunities
On July 20, NCI issued a request for information to compile information from the scientific community on research opportunities in cancer immunotherapy and immunoprevention.

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ASCO Meets with CMS to Express Concern about Proposed Medicare Fee Schedule Cuts,
On July 30, ASCO CEO Allen Lichter, MD, and ASCO staff and counsel met with the acting administrator and relevant staff of the Centers for Medicare & Medicaid Services (CMS) to express deep concern about the cuts to oncology in the proposed Medicare fee schedule and to ask CMS to abstain from using the flawed AMA data to implement the cuts.

Some of the key points ASCO made during the meeting included:

• Due to continuing erosion in resources available to care for cancer patients, oncology practices are already struggling in the current environment.
  
• CMS should not use the PPIS data to determine practice expense payments for oncology practices.
  
• Oncology does not fit into many aspects of the current practice expense calculation methodology.
  
• CMS is required by statute (the Medicare Modernization Act of 2003) to use the practice expense data from the Gallup survey and to update it appropriately.

Also on July 30, Representatives Charlie Gonzalez (D-TX) and Mike Rogers (R-MI) circulated a "Dear Colleague" letter to members of the House of Representatives, urging their colleagues to join them in signing a letter to U.S. Health and Human Services Secretary Kathleen Sebelius. The letter expresses Congress’s concerns about how proposed cuts to oncology and cardiology in the Medicare fee schedule would place vital patient care services, like chemotherapy, at risk.

Please call or write your Representative and ask him or her to sign the letter to Secretary Sebelius. You can find everything you need to contact your member of Congress - including talking points, contact information and a draft email/letter - on ASCO's Grassroots Action Network.

Additionally, ASCO is asking practicing oncologists to complete a brief survey to provide information on how these cuts will impact you and your patients. Please take a moment to answer four short questions on the survey. ASCO will share the survey results with leaders in Congress, the Administration, and the public, to demonstrate the real-world impact of these cuts on your practices and your patients. Please respond to the survey no later than Wednesday, August 5.

Contact ASCO's Cancer Policy and Clinical Affairs Department with any questions, or to share your story about how the proposed cuts will harm your practice and your patients, at 571-483-1670 or publicpolicy@asco.org.

House Committee Includes Important ASP Provision in Health Reform Legislation
The House Energy and Commerce Committee voted to include language in its health care reform legislation that would remove many of the prompt pay discounts extended to drug wholesalers from the manufacturers’ Average Sales Price (ASP) calculation.

The amendment, passed on July 30, would exclude prompt-pay discounts under ASP reporting of up to 2 percent of the wholesale acquisition cost of a drug for the period between January 1, 2011 and January 1, 2016.

ASCO supports the inclusion of this language in the health reform bill and has long supported legislation that would remove the prompt pay discounts from ASP. Including the discounts artificially lowers the reimbursement rate for chemotherapy treatments, resulting in some cases to reduced patient access.

While this is a positive development, this is one step in a very long process. The bill will proceed through the House process and have to be reconciled with the other pieces of health reform legislation in the House and Senate.

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

FY 2010 Appropriations Update
The Senate Appropriations Committee passed a FY 2010 Labor-HHS-Education Appropriations bill on July 30, which includes $30.8 billion in funding for the National Institutes of Health (NIH).

The Senate has not yet allocated funds specifically to the National Cancer Institute (NCI). The bill will go the full Senate for a vote, possibly this week. If no vote occurs before the Senate is set to go on recess August 7, the vote on this measure will take place in September.

On July 24, the House of Representatives passed its FY 2010 Labor-HHS-Education spending bill that would give NIH a $942 million funding increase from FY 2009 levels. The funding amount allocated for NIH is $31.3 billion, with $5.15 billion for NCI.

ASCO continues to advocate for increased and sustained funding for both the NIH and NCI. For more information, contact ASCO's Cancer Policy & Clinical Affairs Department at 571-483-1670 or publicpolicy@asco.org.

FDA Approves Onsolis with Risk Evaluation and Mitigation Strategy
On July 16, the Food and Drug Administration (FDA) approved Onsolis (fentanyl buccal soluble film) for use in certain patients with cancer to help manage breakthrough pain – severe flares of pain that are not alleviated by regular pain medication.

Onsolis will be available under an FDA-approved Risk Evaluation and Mitigation Strategy (REMS). As part of the REMS for Onsolis, the drug will only be available through a restricted distribution program, called the FOCUS Program. The FOCUS Program prescription process includes the following steps:

• Each patient, prescriber, distributor, and pharmacy must complete an enrollment process to enroll in the FOCUS Program.
  
• The prescriber must fax the initial prescription information for Onsolis to the FOCUS Program to start the verification process.
  
• The prescriber must send the original, hardcopy prescription for Onsolis to a FOCUS pharmacy via courier using the supplied shipping label.
  
• While the original, hardcopy prescription is in transit, the FOCUS pharmacy must confirm that the patient and prescriber are active in the FOCUS Program database and the patient counseling call has been successfully completed; prepare the medication; and schedule Onsolis delivery to the patient.
  
• Upon receipt of the original, hardcopy prescription, the FOCUS pharmacy will dispense Onsolis and deliver the medication directly to the patient via a secure, traceable courier (with adult signature required).

FDA has stated that approval of Onsolis is independent of FDA’s consideration of a larger REMS for extended-release and high-potency opioid drugs. However, ASCO is concerned that implementation of this approach across all opioid drugs could have grave consequences for patient access to this medication.

Additional information about Onsolis can be found on the FDA Web site. More information about the FDA’s ongoing initiative to develop a REMS for opioids also is available on the FDA Web site. ASCO’s comments to the FDA about the larger REMS are available in the July 20 issue of the Cancer Policy Today.

New Compliance Date Set for “Red Flags” Rule
The Federal Trade Commission (FTC) recently extended the compliance date for its “red flag” rule to November 1. This rule would require creditors and financial institutions to implement programs and policies to identify, detect, and respond to potential risks of identity theft.

FTC extended the deadline to allow small business more time to understand and become compliant with the requirements of the rule. FTC has a frequently asked questions document and a guide for covered entities to help covered entities comply with the rule.

The American Medical Association (AMA) also has published tools and resources on these rules. AMA offers a red flag rules guidance document and a sample policy for physicians and their practices.

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

NCI Requests Information on Immunotherapy Translational Opportunities
On July 20, NCI issued a Request for Information to compile information from the scientific community on research opportunities in cancer immunotherapy and immunoprevention that would benefit from accelerated development through focused funding and coordinated management.

This request is part of NCI’s new Process to Accelerate Translational Science as recommended by the Translational Research Working Group. The information gathered may be used by NCI in a variety of ways, including:

• To assist in the development of Requests for Proposals, Requests for Applications, Program Announcements, Cooperative Research and Development Agreements, and Cooperative Agreements, including a limited number of Special Translational Research Acceleration Projects.
  
• To inform the development, formulation, production and implementation of products/devices/processes through internal NCI mechanisms.

NCI is looking for information regarding the immunogenicity and therapeutic function of an antigen, the scientific validity and feasibility of the formulation for that antigen, or the scientific validity and feasibility of combinations with immune modifier agents. In addition, information on assays of immune response, assays for patient selection, and the availability of patients for clinical trials, is also requested.

All responses are due by August 24. A template for the responses can be found on the NCI Web site. For more information, contact NCI at NCI-RFI-IRMPathway@mail.nih.gov.

News and Notes
Participate in QOPI and the QOPI Certification Program
ASCO recently announced the QOPI® Certification Program, a program to 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. This publication 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 resource is a must-have for oncology practices. Order yours today by visiting www.asco.org/practicaltips or by calling 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.