March 19: FDA Advisory Committee Votes to Continue ESA Use in Cancer Patients, Reps. Eshoo, Barton Introduce Pathway for Biosimilars Act
FDA Advisory Committee Votes to Continue ESA Use in Cancer Patients
On March 13, the Oncology Drugs Advisory Committee (ODAC) of the Food and Drug Administration (FDA) voted 13 to 1 to continue using erythropoiesis-stimulating agents (ESAs) in cancer patients undergoing chemotherapy.
ODAC made the following recommendations to FDA:
Preserve the chemotherapy-induced anemia indication for ESAs.
Do not restrict ESA use only to patients with small cell lung cancer.
Modify the current indication to include a statement that ESA use is not indicated for patients receiving potentially curative treatments.
Modify the current indication to include a statement that ESA use is not indicated for patients with metastatic breast and/or head and neck cancers.
Require the use of a signed informed consent/patient agreement for the treatment of chemotherapy-induced anemia, but do not mandate a restricted distribution system for oncology patients receiving ESAs.
The ASCO/ASH guideline update issued in November 2007 addressed recent data on the safety of ESAs.
ASCO does not yet know which of these recommendations FDA will accept or when and how they will be implemented but will keep members apprised of additional developments.
ASCO has also prepared a more in-depth summary of the recommendations. For more information, please contact ASCO's Cancer Policy & Clinical Affairs Department at 703-299-1050 or publicpolicy@asco.org.
Senators Stabenow, Bunning introduce Save Medicare Act On March 13, Sens. Debbie Stabenow (D-MI) and Jim Bunning (R-KY) introduced the Save Medicare Act in the Senate to delay the pending 10.6% physician pay cut 18 months, extend the 0.5% update until the end of the year and boost the update to 1.8% in 2009.
Last month, Reps. Tom Price (R-GA) and David Scott (D-GA) introduced legislation in the House that replaces the cuts with 1% update from July 1 to December 31 in addition to a 1.8% update through December 31, 2009.
At the end of 2007, Congress passed a Medicare bill that would avert the scheduled 10.1% cut by replacing it with a 0.5% increase in Medicare payments for first six months of 2008. Congress would need to act before July 2008, or the cut will go into effect at that time.
For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department at 703-299-1050 or publicpolicy@asco.org.
Senate Passes Amendment for $2.1 Billion NIH Funding Increase On March 13, the Senate passed an amendment to its FY 2009 budget resolution that would add $2.1 billion to the National Institutes of Health (NIH) budget, to increase funding for research and discovery in the life sciences. This would represent a 7.2% funding increase for NIH from FY 2008.
The amendment, which passed by a vote of 95 to 4, was introduced by Sens. Arlen Specter (R-PA) and Tom Harkin (D-IA). This budget resolution (S Con Res 70) is a non-binding document that sets aggregate spending and revenue targets for the fiscal year. The House adopted its version of the FY 2009 budget resolution (H Con Res 312) on Friday. It did not include a similar amendment.
The amendment comes two days after the release of a new report, “A Broken Pipeline? Flat Funding of the NIH Puts a Generation of Science at Risk.” The report, co-authored by researchers at UCLA and five other academic research institutions, focused on the scientific and career development deficiencies caused by flat funding, including lost opportunities for early-career investigators.
According to the report, the number of first-time investigators who received grants from the NIH Research Project Grant Program (R01 grants), the original grant mechanism used by NIH, is increasingly declining. The report also states that average age of first-time R01 grant recipients is also increasing.
In addition, a bipartisan “Dear Colleague” letter has been circulating in the House of Representatives supporting NIH budget increases. The deadline to sign the letter was March 18, and, as of March 17, the letter had 175 signatories.
For more information on any of these issues, contact ASCO's Cancer Policy & Clinical Affairs Department at 703-299-1050 or publicpolicy@asco.org.
Reps. Eshoo, Barton Introduce Pathway for Biosimilars Act On March 13, Reps. Anna G. Eshoo (D-CA) and Joe Barton (R-TX) introduced the Pathway for Biosimilars Act to create a regulatory pathway for FDA approval of “biosimilars” or “follow-on” biologics.
One of the main areas of focus is the degree to which biogenerics can be substituted for the brand product (so-called “interchangeability”). This bill provides basic data requirements (analytic data, animal testing and clinical studies) needed to categorize a biogeneric as a “biosimilar” product. The bill also provides a mechanism for the FDA to determine interchangeability.
The Senate Health, Education, Labor and Pensions (HELP) Committee included a biogenerics provision in FDA legislation last year, but it did not remain in the final bill signed into law.
For more information on this issue, contact ASCO's Cancer Policy & Clinical Affairs Department at 703-299-1050 or publicpolicy@asco.org, or visit ASCO’s Web site.
The goal of all of the cancer treatment plans and summaries is to improve patient treatment across health care settings by facilitating communication among oncologists, patients and other care providers.
The treatment plan and summary templates are available in a modifiable format, allowing oncologists to customize them to suit their own practices. Templates for additional disease sites will be published in the coming months.
For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department at 703-299-1050 or cancerquality@asco.org.
ASCO Comments on NIH Peer-Review Process On February 28, NIH released for public comment a final draft report on its peer review system. The report identifies the most significant challenges facing the NIH peer review system and proposes recommended actions.
On March 17, ASCO submitted comments to NIH in response to the draft report.
ASCO applauded proposals aimed at enhancing the pool of peer reviewers, including permitting more flexible review service, providing more flexible grant-submission deadlines, and linking study-section service to the most prestigious rewards.
The Society also was pleased that the self study includes strong recommendations for enhancing the funding of early career investigators.
ASCO’s comments were largely based on previous comments it made to NIH last September on its peer review system.
For more information, contact ASCO's Cancer Policy & Clinical Affairs Department at 703-299-1050 or researchpolicy@asco.org.
The Family Smoking Prevention and Tobacco Control Act Advances to House Energy and Commerce Committee On March 11, The Health Subcommittee of the House Energy and Commerce Committee voted to advance The Family Smoking Prevention and Tobacco Control Act (H.R.1108) after a prolonged two day mark-up session. The full Energy and Commerce Committee plans to mark-up the bill shortly after the spring recess in the beginning of April.
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. S.625, the Senate companion bill, passed out of committee on August 1. The House bill has 217 co-sponsors, and the Senate bill has 56.
More than 600 national and local public health organizations support H.R.1108. ASCO encourages members of Congress to support this legislation and reject efforts to weaken it as it moves through the legislative process.
For more information, contact ASCO’s Cancer Policy and Clinical Affairs Department at 703-299-1050 or publicpolicy@asco.org.
Public Comment Period Open for Draft Clinical Trials Policy Recommendations The Eliminating Disparities in Clinical Trials (EDICT) Project is seeking public comment on its draft policy recommendations addressing recruitment and retention of underrepresented participants in clinical trials.
EDICT’s national alliance of scientists, public health leaders, and community representatives has drafted a series of proposals designed to eliminate continued disparities in U.S. clinical trials.
Comments are due by March 21. EDICT has a web-based portal where individuals can review the proposals and provide feedback. EDICT will issue its final policy recommendations on April 1.
Carrier Holding Online Training Sessions on Competitive Acquisition Program The Centers for Medicare & Medicaid Services (CMS) announced that Noridian Administrative Services, the carrier for the Competitive Acquisition Program (CAP), will hold online workshops on using CAP for Part B Drugs & Biologicals for providers and staff.
The workshops will be held April 22 at 2:00 PM CDT and May 28 at 10:00 AM CDT. Participating physicians and their staff are encouraged to participate in the workshops.
CMS Issues New Advanced Beneficiary Notice Forms
CMS has replaced the existing General Use Advanced Beneficiary Notice (ABN) (form CMS-R-131-G) and the Laboratory ABN (form CMS-R-131-L) for physician-ordered laboratory tests with a new form.
The new form is titled the ABN of Noncoverage, and its form number is CMS-R-131. The form can be used in place of the Notice of Exclusion from Medicare Benefits (NEMB), and it includes a mandatory field for cost estimates.
A six month transition period started March 3 and will run through September 1, at which time the new form must be used.
For more information on this new form, visit the CMS Web site.
Follow-Up to Recent Recovery Audit Contractor (RAC) Audits in Florida The Cancer Policy & Clinical Affairs staff has received a number of follow-up calls from oncology providers relating to the Florida recovery audit contractor (RAC) audits, conducted by HealthDataInsights Inc. (HDI) that centered on drug administration add-on codes in 2005.
HDI told ASCO that it would send notifications out to providers that audits containing certain G-codes have been rescinded. ASCO staff recently learned that providers would not receive notification if a demand letter requesting payment was not issued.
If you have an outstanding RAC audit on any of the following codes; G0348, G0350, G0360, or G0362, call HDI at 888-700-3282, ext. 1141, to check the status of the audit. Please note that you need to have the audit number available for HDI staff to verify the status.
Contact Julia Tomkins in the Cancer Policy & Clinical Affairs Department with any questions at 703-299-1050 or tomkinsj@asco.org.
News and Notes
New ESA Instruction Sheet Available on ASCO Web site
A new instruction sheet on reporting hematocrit/hemoglobin in conjunction with claims for erythropoiesis-stimulating agents (ESAs) is now 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.
Watch your Mail for Physician Practice Information Survey
The American Medical Association (AMA) and more than 70 other organizations, including ASCO, are conducting a comprehensive multi-specialty survey of U.S. physician practices. The results will be used to positively influence national decision makers to ensure accurate and fair representation for all physicians and patients and to communicate the challenges of running a practice that provides expert patient care while maintaining sustainability. CMS stated it will use the study results to help determine physician payments. The survey firm, Dmrkynetec, will survey randomly selected physicians and practice managers. Please encourage your staff to participate, as the survey’s success depends on accurate and complete data. All responses will remain confidential.
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.
