As 2007 draws to a close, we would like to take this opportunity to update you on some important cancer policy activities that have taken place this year. Below you will find an update on some of the major legislative and regulatory activities affecting oncologists this year, as well as programmatic accomplishments in the policy arena.
Update on Legislative and Regulatory Activities
NIH Appropriations Update
Yesterday, Congress passed a $555 billion omnibus budget package that includes FY2008 Labor-HHS-Education appropriations. The bill contains $28.942 billion for the National Institutes of Health (NIH), an increase of $133 million, and $4.805 billion for the National Cancer Institute (NCI), an increase of $12.4 million.
The President is expected to sign the bill into law.
ASCO will continue to monitor this issue. For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department at 703-299-1050 or publicpolicy@asco.org.
Congress Approves Medicare Bill
Yesterday, Congress also 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. This means the Congress would need to act before July 2008, or the cut will go into effect at that time. The bill, S. 2499, also:
- Implements recommendations from a report released by the Department of Health and Human Services’ Office of the Inspector General in 2006 to require the Centers for Medicare & Medicaid Services (CMS) to adjust its Average Sales Price (ASP) calculation to use volume-weighted ASPs, based on actual sales volume. The impact of this provision is difficult to determine, but it may result in decreases in payments for some Part B drugs.
- Extends the physician quality reporting system.
- Extends funding for the State Children’s Health Insurance Program (SCHIP) through March 2009.
For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department at 703-299-1050 or publicpolicy@asco.org.
Update on FDA Reform Bill
On September 27, the President signed H.R. 3580, the Food and Drug Administration Amendments Act of 2007 (FDAAA), expanding FDA oversight of prescription drug safety and reauthorizing the Prescription Drug User Fee Act.
The following provisions of the bill are likely to affect the cancer community:
- Drug Safety: The law gives FDA authority to require pharmaceutical companies to conduct post-marketing studies to assess a known serious risk and signals of a serious risk, or identify an unexpected serious risk. The bill empowers FDA to require companies to submit “Risk Evaluation and Mitigation Strategies” and to impose fines on companies for failure to follow post-market safety procedures.
The legislation also provides mechanisms for FDA to conduct risk identification and analysis of marketed drugs. FDA would be required to establish public, academic and private partnerships that would allow for active mining of electronic health databases for the purposes of post-market safety surveillance. Currently, the U.S. Drug Safety System relies on the voluntary reporting of health practitioners and patients to assess drug safety signals.
- Conflict of Interest Waivers: FDA will face limits on the number of waivers it will be able to issue for members of its advisory committees. The compromise provision requires the agency to calculate the combined number of waivers granted this year and decrease that number by 5 percent each year between 2008 and 2012. Additionally, disclosure of waivers would have to be made public at least 15 days before an advisory committee meeting.
- Clinical Trials Database Becomes Mandatory: Sponsors of all clinical trials involving drugs, biologics and devices will be required to provide information to a clinical trials registry. Sponsors who fail to comply with this requirement would face monetary penalties. The bill also requires HHS to develop rules for potential inclusion of clinical trial results in a separate database.
Other provisions include establishment of user fees for the review of Direct-to-Consumer advertisements, authority to require a preview of pharmaceutical TV ads, and reauthorization of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act.
Currently, FDA is struggling to implement FDAAA-required provisions due to a lack of appropriations. The current version of the omnibus budget package increases FDA appropriations $145 million over FY2007 funding levels, although a bulk of this money is directed toward food safety. A recent report from the FDA Science Board Subcommittee on Science and Technology states that FDA suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities. About 25 cents of every consumer dollar spent in the United States is on products regulated by FDA. However a history of chronic underfunding in conjunction with increasing responsibilities placed on the agency, the extraordinary advance of scientific discoveries, the complexity of the new products and claims submitted to FDA for pre-market review approval, the emergence of challenging safety problems, and globalization of the industries that FDA regulates has led to deficiencies that now pose safety risks to the public.
For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department at 703-299-1050 or researchpolicy@asco.org.
Update on the Use of ESAs in Patients with Cancer
In March 2007, FDA issued new black box warnings on erythropoiesis-stimulating agents (ESAs), based on new studies regarding the safety and appropriate use of these therapies. In July, CMS issued a National Coverage Decision that significantly restricted coverage for ESAs.
In October, ASCO and the American Society of Hematology (ASH) issued an updated clinical practice guideline on the use of ESAs that included a series of recommendations based upon published, peer-reviewed scientific evidence. The guideline recommends the use of ESAs as a treatment option for cancer patients who become anemic as a result of chemotherapy when their hemoglobin approaches or falls below 10 g/dL, as well as patients with low-risk myelodysplasia. The guideline also states that when using ESAs, hemoglobin can be raised to (or near) a concentration of 12 g/dL, at which point the dosage should be titrated to maintain that level.
In November, FDA issued new product labeling changes for the use of ESAs in patients with cancer. ASCO is continuing to monitor this issue and will keep members apprised of further changes.
For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department at 703-299-1050 or publicpolicy@asco.org.
Update on Policy Programmatic Accomplishments
ASCO Collaborates with Health Plans to Recognize Quality Care
In early December, ASCO expanded its Quality Oncology Practice Initiative (QOPI®), by collaborating with leading health plans to recognize oncologists who are actively involved in assessing and improving the quality of care provided to patients with cancer.
Participating health benefits companies and associations now are able to recognize physicians that participate in the QOPI program through a method or initiative that each deems appropriate, such as including a special designation for QOPI participants in physician directories or providing financial incentives for participating.
Oncology practices seeking more information about the QOPI Health Plan Program can call (703) 519-2943 or email qopi@asco.org.
CMS Will Continue to Cover Cancer Patients in Clinical Trials
In a major victory for cancer care, CMS stated October18 that it would not change its clinical trials coverage policy. In addition, Congress included language in the omnibus appropriations bill that directs the HHS Secretary to maintain current Medicare clinical trials coverage.
The Agency’s proposal under consideration would have rescinded automatic Medicare coverage that began in 2000 for clinical trials funded by the federal government or conducted under FDA review. The proposal would have required that sponsors or principal investigators self-certify that the clinical trial meets 13 scientific and technical standards set forth by CMS before the agency would approve coverage.
ASCO and many others in the cancer community pressed CMS for months to maintain the current clinical trial coverage. The agency has left open the possibility that it may revisit the clinical trials coverage policy, so ASCO will closely monitor the issue during 2008 and alert membership to any potential changes.
For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department at 703-299-1050 or publicpolicy@asco.org.
Expanded Access to Unapproved Cancer Treatments
In response to a request by ASCO and the National Coalition for Cancer Survivorship (NCCS), FDA developed a draft regulation on the circumstances in which sponsors of new drugs can establish "expanded access" programs to give some patients access to investigational products outside of clinical trials. A second draft regulation describes situations in which investigators and sponsors may charge for drug products administered in clinical trials. ASCO and NCCS submitted comments in support of these draft regulations.
This past February, ASCO, NCCS and the Association of American Medical Colleges (AAMC), submitted an amicus brief in support of FDA in the U.S. Court of Appeals for the District of Columbia Circuit in the case of Abigail Alliance v. Andrew von Eschenbach.
In the brief, ASCO, NCCS and AAMC stated that the demand of the Abigail Alliance to provide patient access to drugs after phase I testing would pose substantial risk, not only to individual patients, but also to the entire clinical trial enterprise.
The brief states that phase I trials do not provide an adequate assessment of safety, much less efficacy, to warrant making an investigational drug commercially available at that point. NCCS, ASCO and AAMC also expressed concern about other potential impacts of the proposal, including the risk of patient harm, the adverse impact on participation in cancer clinical trials, the effect on insurance reimbursement for cancer therapy, and potential liability risk for both physicians and pharmaceutical sponsors.
In August, the Court of Appeals ruled that terminally ill patients do not have a constitutional right of access to experimental drugs that have not been approved by FDA. The Abigail Alliance has requested Supreme Court review of the case.
ASCO will continue to urge FDA to strengthen expanded access programs to allow people with cancer access to enhanced treatment options while preserving the research system so vital to the delivery of more effective therapies.
For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department at 703-299-1050 or researchpolicy@asco.org.
ASCO Study Predicts Oncology Workforce Shortfall by 2020
In March 2007, ASCO presented the findings from its study, “Future Supply and Demand for Oncologists: Challenges to Assuring Access to Oncology Services,” that projected a significant shortage of medical and gynecologic oncologists in the United States by 2020.
The study, which was conducted by the Association of American Medical Colleges Center for Workforce Studies, found that an aging and growing population, increasing numbers of cancer survivors, and slower growth in the supply of oncologists will result in a shortage of 2,550 to 4,080 oncologists by 2020.
ASCO created a Workforce Implementation Group (WIG) to address the findings raised by the study and to make recommendations to address this predicted workforce shortage. The WIG is working on additional follow-up research and will be presenting recommendations to the Board in 2008.
For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department at 703-299-1050 or researchpolicy@asco.org.
ASCO Launches Chemotherapy Treatment Plan and Summary Templates
In September, ASCO launched its new chemotherapy treatment plan and summary templates for patients with breast and colon cancers. The chemotherapy treatment plan, which is to be filled out before the patient begins receiving chemotherapy, maps out the patient’s planned treatment. The treatment summary, developed after treatment is complete, describes what care the patient actually received.
The goal of these tools is to improve communication among oncologists, patients and other care providers to better manage breast cancer patients’ treatment across health care settings. It will also make gathering data to evaluate and improve quality of care and patient outcomes more accurate and efficient. ASCO is continuing to develop and test treatment plans and summaries for additional cancer diagnoses, including lung cancer.
For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department at 703-299-1050 or cancerquality@asco.org.
ASCO Events Educate Physicians on Oncology EHRs
ASCO hosted an Electronic Health Record (EHR) Roundtable this past January, at which senior thought leaders from government, academic centers, community-based oncology practices, and patient advocacy organizations discussed their experiences with EHR selection and implementation and developed recommendations for critical components of oncology EHRs.
ASCO held an EHR lab at the 2007 ASCO Annual Meeting, where 11 vendors demonstrated their ability to integrate the ASCO-developed treatment plan and summary into their oncology-specific EHR products. ASCO also sponsored the “EHR: 2007 Oncology Symposium” in September to provide ASCO members with tools and resources to make an EHR decision. Seven vendors participated, and educational events included vendor demonstrations, a vendor challenge, and educational sessions on a variety of topics. In spring 2008, ASCO will release a field guide to help oncologists with selection and implementation of EHRs
For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department at 703-299-1050 or visit www.asco.org/ehr.
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