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Home > Legislative & Regulatory > Legislative and Regulatory Issues > Cancer Policy News > Cancer Policy Today


February 20: Senate Committee Holds Hearing on Physician Workforce Issues, Congress and Administration Propose Approval of Generic Biologics


Contact Your Senators Regarding Medicare Physician Payments
Current Medicare physician payment rates are scheduled to be cut by 10.6% on July 1, and by an additional 5% on January 1, 2009. Only Congressional action can prevent these cuts, replacing the cuts with updates that cover practice cost increases and preserve access for people living with cancer.

Currently, Medicare physician payment rates are, on average, the same as in 2001, while practice costs have risen 20% since then. ASCO is concerned about the widening gap between payment rates and the cost of care that will make it extremely difficult for physicians to stay involved with the Medicare program.

Senators are currently home for the President's Day Congressional Recess (February 15-25). Please take this opportunity to reach out to your Senators and impress on them the importance of preventing cuts to Medicare that will endanger the access to care for people with cancer. For a sample letter on this issue and contact information for your Senators, visit ASCO’s Grassroots Action Center.

If you have any questions, or would like more information, contact ASCO’s Cancer Policy & Clinical Affairs Department at 703-299-1050 or grassroots@asco.org.

Senate Committee Convenes Hearing on Physician Workforce Issues
Last week, the Senate Health, Education, Labor and Pension (HELP) Committee took a closer look at physician workforce issues at a hearing, “Addressing Healthcare Workforce Issues for the Future.”

While the hearing focused on workforce shortages in primary care, access to care in rural areas, student loans and minority physicians, ASCO submitted a statement to the Committee focusing on the projected shortage of oncologists.

According to the ASCO study, by 2020 there will be a shortage of between 2,550 and 4,080 oncologists, which could lead to 9.4 million to 15 million fewer oncologist visits. While the number of oncologists has grown over the past two decades, supply is only projected to increase 20% between now and 2020. Over that same period, demand for oncologist services is expected to increase by 48%, due to the aging population and growth in number of cancer survivors.

When the primary care physician shortage is combined with the current nursing shortage, it translates into a challenge for the entire oncology care team and the delivery of quality cancer care, due to the collaborative nature of oncology care.

In response to the projected shortage, ASCO formed the Workforce Implementation Group in early 2007 to develop comprehensive recommendations to address how all of ASCO’s programs and services can help ensure the future delivery of oncology services. A key component will be collaboration among health care professionals to ensure continuity and quality of care, particularly for cancer survivors.

ASCO will provide additional information to Senate Committee staff about workforce issues that are affecting oncology and will report on any new findings.

For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department at 703-299-1050 or workforce@asco.org.

Congress and Administration Propose Approval of Generic Biologics
Key Members of Congress and the President are renewing interest in legislation to establish an approval pathway for generic versions of biologic pharmaceutical products, or biogenerics.

The Food & Drug Administration (FDA) indicated last week that it would work with Congress to help develop legislation addressing biogenerics approval. The Senate HELP Committee included a biogenerics provision in FDA legislation last year, but it did not remain in the final bill signed into law. The provision was introduced by Sens. Kennedy (D-MA), Hatch (R-UT), Clinton (D-NY), and Enzi (R-WY) as S. 1695. In the House, Rep. Waxman (D-CA) introduced H.R. 1038 last year, which is largely supported by the generic drug industry. Reps. Eshoo (D-CA) and Barton (R-TX) are also working on legislation this year that is reportedly closer in concept to the Senate bill.

One of the main points of contention in these legislative proposals is the degree to which biogenerics can be substituted for the brand product (so-called “interchangeability”). S. 1695 provides basic data requirements (analytic data, animal testing and clinical studies) needed to categorize a biogeneric as a “biosimilar” product. H.R. 1038 contains fewer data specifications and provides the FDA with more flexibility to determine whether a biogeneric product is “comparable” to the brand product.

Both bills include provisions that would make the biosimilar or comparable product interchangeable with the brand product, meaning it can be substituted for the brand product without the intervention of the health care provider who prescribed it. To demonstrate interchangeability, the generic manufacturer must provide evidence that the biosimilar or comparable product can be expected to produce the same clinical result as the brand product in any given patient. S. 1695, however, includes another requirement that the biogeneric product must present no additional risk in terms of safety or diminished efficacy if a patient alternates or is switched between products.

The debate also will likely focus on how many years of patent protection should be provided to the brand product and the degree to which biogenerics will produce savings for the consumer and the health care system.

More information about this issue is available on the ASCO Web site.

NCI Advancing Cancer Research Through Biospecimen Science Symposium
The National Cancer Institute Office of Biorepositories and Biospecimen Research and the National Institutes of Health Office of Rare Diseases will hold the Biospecimen Research Network Symposium March 13-14, in Washington, DC.

The primary goal of the symposium is to address the significant impact of pre-analytical biospecimen variability on cancer research and molecular medicine. The symposium is open to the public and is expected to be of particular value to research investigators, clinicians, government representatives, industry representatives, hospital administrators, and patient advocates.

For more information, to register, and to submit an abstract, go to www.brnsymposium.com.

ASCO Requests Recognition of NCCN and DrugPoints Compendia for Off-label Coverage of Anti-cancer Drugs
On February 11, ASCO sent letters to the Centers for Medicare & Medicaid Services (CMS) requesting that the National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium and the DrugPoints Compendium both be recognized as authoritative compendia for off-label coverage of anti-cancer drugs.

Medicare coverage of new drug uses is necessary to ensure appropriate care of cancer patients. Section 1861(t)(2) of the Social Security Act establishes a special coverage rule for drugs used in cancer chemotherapy regimens. The provision requires Medicare to cover Part B drugs administered in physician offices and hospitals when used for indications approved by the FDA, and, in the case of unapproved uses of approved drugs, when the uses are supported by citations listed in the Act. This Section currently lists certain compendia and allows CMS to identify additional authoritative compendia. CMS recently initiated a process to review on an annual basis possible additions to the current list of compendia.

ASCO believes that both the NCCN and DrugPoints Compendia meet CMS’s definition of compendia and satisfy the desirable characteristics of a compendium as defined by the Medicare Evidence Development and Coverage Advisory Committee.

For more information, contact ASCO's Cancer Policy & Clinical Affairs Department at 703-299-1050 or publicpolicy@asco.org.

Recent Recovery Audit Contractor (RAC) Audits in Florida
The Cancer Policy & Clinical Affairs Department heard from many oncology practices in Florida regarding audits conducted by HealthDataInsights Inc., a recovery audit contractor (RAC). A number of the audits centered around add-on codes, which included many of the 2005 drug administration codes.

Based on the scope of the audit, it was clear that the RAC did not fully understand the appropriate use of the drug administration codes. ASCO contacted the contractor and provided documentation on the correct use of the codes. ASCO also wrote a letter to CMS regarding the audits. ASCO was notified that the RAC would rescind or stop audits that were specifically related to the drug administration G-codes (more specifically the add-on codes) and that letters would be sent to providers regarding the audit status.

ASCO's involvement in these audits and efforts made to educate the contractor was a direct impact of hearing from ASCO members.

If you have concerns related to a RAC or a RAC audit, contact Julia Tomkins in the Cancer Policy & Clinical Affairs Department 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 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 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.