Obama/Biden Administration Priorities for Cancer Care
President-elect Barack Obama outlined his cancer care priorities during the presidential campaign. ASCO leaders met with the Obama campaign a few weeks ago to ensure cancer care issues remain on the agenda of the incoming Administration.

President-elect Obama has publicly declared a commitment to doubling federal funding for cancer research over the next five years, improving access to clinical trials and preventative health care measures, and ensuring all Americans have affordable, quality health care. Accomplishing this ambitious agenda will be challenging given the economic situation, competition for resources, and ongoing wars in Iraq and Afghanistan.

In the coming weeks, the President-elect also is expected to name the heads of the agencies that will oversee his health care initiatives, including the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the National Cancer Institute (NCI).

The new Congress is also starting to unveil its health care priorities. On November 12, Sen. Max Baucus (D-MT), Chairman of the Senate Finance Committee, released a comprehensive health care reform plan, which he says will “dovetail” with the Obama plan. Additionally, Sen. Ted Kennedy (D-MA), Chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, is working on his own health care reform initiatives, but is expected to follow the lead of President-elect Obama.

House Ways and Means Health Subcommittee Chairman Pete Stark (D-CA) issued a statement indicating his subcommittee will work with the incoming Administration on health care reform. In the House, the Energy and Commerce Committee and the Ways and Means Committee both have jurisdiction over health care issues.

ASCO stands ready to work with the incoming Obama Administration and Members of the 111th Congress.

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

NCI and CEO Roundtable on Cancer Develop Standard Clinical Trial Contract Language
NCI and the CEO Roundtable on Cancer jointly released “Proposed Standardized/Harmonized Clauses for Clinical Trial Agreements” that offers common language for clinical trials contract agreements.

The effort it takes to negotiate clinical trial agreements between industry and research sites can sometimes impede the timely launch of clinical trials. Topics covered in the proposed agreements include intellectual property, subject injury, indemnification, data, confidentiality, and publication rights.

Use of the language proposed in the recommendations is not mandatory but rather was designed to be a starting point for clinical trials contract negotiations. For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department at 571-483-1670 or researchpolicy@asco.org.

CMS Issues Final Medicare Physician Payment Rule for 2009
On October 30, the Centers for Medicare & Medicaid Services (CMS) issued its final 2009 physician fee schedule.

The provisions of the most importance to oncologists include:

• Announcement of 2009 Conversion Factor: The conversion factor will be $36.0666, compared to the 2008 conversion factor of $38.0870. Although the updated conversion factor is an increase of 1.1 percent due to the passage of the Medicare Improvements for Patients and Provider Act (MIPPA) earlier this year, the conversion factor has been adjusted downward by 6.41 percent in a budget neutrality adjustment to account for relative value increases made as a result of the 5-year review of physician work relative values for all codes. CMS estimates that the net effect on hematology/oncology from this and other changes will be a 1 percent reduction.
  
• RUC Practice Expense Recommendations: The American Medical Association’s Relative Value Update Committee (RUC) recommended revising the practice expense relative values for several chemotherapy administration codes.
  
• Payments for drugs: CMS will discontinue the pre-administration payment for Intravenous Immune Globulin for 2009. CMS is updating its regulations to reflect statutory changes in the calculation of average sales price (ASP) for drugs that went into effect April 1, 2008. CMS had proposed several minor refinements to the Competitive Acquisition Program (CAP) for drugs. Because the CAP has been suspended, CMS did not finalize its proposals.
  
• Coverage of Additional Preventive Services: MIPPA authorizes CMS to extend coverage under Medicare Part B for additional preventive services through the national coverage determination process.
  
• Physician Quality Reporting Initiative (PQRI): MIPPA provides a 2 percent bonus payment in 2009 for participation in the PQRI. CMS will include several new quality measures related to cancer treatment.
  
• Electronic Prescribing Incentive Program: For 2009, a “successful electronic prescriber” will receive a 2 percent bonus payment. After 2009, the payment incentive will decrease, and in 2012 physicians who don’t e-prescribe will face a penalty.
  
• Standards for Providing Diagnostic Services: Medicare has deferred action on its proposal to apply Independent Diagnostic Testing Facilities (IDTF) standards to physician offices.
  
• Anti-Markup Provisions. CMS has modified the new “anti-markup” rules that prohibit physicians from charging Medicare more than the cost of diagnostic services that were either purchased or furnished by an employee or contractor at a site different from the office of the billing physician.

A more detailed summary of the regulations is available online. For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department at 571-483-1670 or practice@asco.org.

CMS Issues Final Hospital Outpatient Payment Rule for 2009
On October 30, CMS issued its interim final rule with a comment period for the Hospital Outpatient Prospective Payment System (HOPPS) payment policies for 2009.

The provisions of the most importance to oncologists include:

• Reimbursement for Separately Paid Drugs and Biologics: CMS will reimburse separately paid drugs and biologicals at ASP plus 4 percent.
  
• Packaging Policies: The packaging threshold for separately paid drugs and biologicals will remain at $60 for 2009.
  
• Radiopharmaceuticals: CMS will continue to package payment for diagnostic radiopharmaceuticals into payments for diagnostic nuclear medicine.
  
• Hospital Quality Reporting Requirements: CMS will continue to implement the provision of the Medicare Improvement and Extension Act requiring hospitals to comply with quality reporting requirements or else risk a 2 percent reduction in their annual update factor.
  
• 340B Hospital Issues: CMS is requesting comment on payment to 340B hospitals for separately paid drugs and biologics, specifically “whether hospitals participating in the 340B program should be paid for drugs under the HOPPS at adjusted rates because they have different average acquisition costs.”
  
• IVIG Pre-Administration Payment: CMS will discontinue the pre-administration payment for IVIG.

A more detailed summary of the regulations is available on the ASCO Web site. For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department at 571-483-1670 or practice@asco.org.

President’s Cancer Panel Releases Report on Combating Cancer
On October 23, the President’s Cancer Panel released a report, Maximizing Our Nation's Investment in Cancer: Three Crucial Actions for America's Health, to identify actions aimed at reducing cancer incidence and death rates.

In the report, the panel made three major recommendations:

• Make cancer prevention and treatment a national priority.
• Create a new health care system so all Americans have access to health care.
• Eliminate tobacco use.

The panel also sent its recommendations to President-elect Barack Obama. For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department at 571-483-1670 or publicpolicy@asco.org.

New NIH Policy Aims to Support Scientists Early in their Careers
On October 31, NIH announced a new policy to encourage funding for scientists who are new to NIH or in the early stages of their careers.

The new policy provides details on how NIH plans to use the newly created “Early Stage Investigator” category announced in late September. The policy is also part of a major initiative under way to enhance the peer review process with a goal of funding the best science with the least amount of administrative burden.

Under the new policy:

• NIH will establish goals to support new investigators at comparable success rates of established scientists submitting new applications.
  
• Early Stage Investigators should make up a majority of the new investigators supported.
  
• Early Stage Investigator applications will be grouped during review so they will be evaluated more effectively when judged against applications from scientists at the same stage of their careers.

The policy is available on the NIH Web site.

FDA Requires Toll-Free Number for Reporting Adverse Effects on Drug Label
FDA passed a final rule requiring drug manufacturers to print a toll-free phone number on drug labels for reporting adverse effects.

The rule states that the toll-free number is only to be used for reporting side effects, not for medical advice. This final rule is effective November 28, and the compliance date is July 1, 2009.

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

New Report Issues Recommendations on Improving Cancer Clinical Trials
On October 21, the Education Network for Advancing Cancer Clinical Trials (ENACCT) and the Community-Campus Partnerships for Health (CCPH) released a report, Communities as Partners in Cancer Clinical Trials: Changing Research, Practice and Policy that issues recommendations on how to better engage communities in cancer clinical trials.

The report addresses how communities can be involved in all aspects of clinical trials, from design to implementation to dissemination of trial results. Key recommendations include developing community advisory boards to enable community members to provide input into local cancer research initiatives and for community members to make up 25 percent of clinical trials institutional review boards.

ENACCT and CCPH are currently searching for “implementation partners” to help carry out the recommendations in a variety of settings. Starting in December 2008, the groups will award one-year seed grants in amounts up to $8,000 for groups who will implement one or more of the recommendations contained in the report. More information on how to apply for this grant is available online.

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

News and Notes
Temporary Suspension of RAC Activities
On November 5, CMS announced an “automatic stay” in the contract work for the four newly awarded recovery audit contractors (RACs). The organization stated that the suspension of work was due to protests filed by two unsuccessful bidders for the program. The suspension of work will remain in place until a decision regarding the protest is provided by the General Accounting Office. For more information, visit the CMS Web site.

NIH Currently Accepting Applications for Loan Repayment Programs
NIH is currently accepting applications for its extramural Loan Repayment Programs (LRPs). The LRPs repay up to $35,000 annually of educational loan debt for people conducting at least two years of qualified research. Go online for more information on how to apply for an LRP.

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 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 answer a few questions about your specific educational needs and how ASCO can help you meet those.

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.