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

Update on Congressional Health Care Reform Activities
On July 14, leaders in the House of Representatives introduced health care reform legislation, America’s Affordable Health Choices Act of 2009 (H.R. 3200).

Update on Proposed Medicare Fee Schedule Cuts
Proposed cuts to the Medicare fee schedule cuts will harm cancer care in the United States.

FY2010 Appropriations Update for NIH and NCI
On July 10, the House Appropriations Labor-HHS-Education Subcommittee approved a FY 2010 spending bill that would give NIH a $942 million funding increase from FY 2009.

ASCO Study Finds Varying Interpretation of HIPAA Privacy Rule Can Delay Cancer Research
On July 20, ASCO published a study in the Journal of Clinical Oncology that shows that research sites differ in their approaches to compliance with federal Privacy Rule requirements, and that these differences can result in delays to important research projects.

ASCO Comments on Conflict of Interest in Federally Funded Research
On July 2, ASCO sent comments to NIH on potential changes to federal regulations regarding financial conflicts of interest in federally funded research.

ASCO Comments on Risk Management Strategy for Prescription Opioids
On June 30, ASCO sent comments to the FDA on its Risk Evaluation and Mitigation Strategy (REMS) for extended-release prescription opioids.

ASCO Comments on Meaningful Use of EHRs
On June 26, ASCO, along with 76 other health and medical organizations, sent comments to the National Coordinator for Health Information Technology in the U.S. Department of Health and Human Services on the meaningful use of EHRs.

Revisions to the Electronic Prescribing Incentive Program
According to the Medicare Physician Fee Schedule, CMS is proposing to simplify the reporting requirements for the electronic prescribing measure and to provide eligible professionals with more reporting options in 2010.

NCI Requests Feedback on Round 3 Modules for Case Report Form Harmonization/Standardization
As previously reported, NCI is taking part in an effort to standardize and harmonize case report forms (CRFs). Currently, NCI is requesting feedback on Round 3 Modules.

Obama Will Nominate Francis S. Collins, MD, PhD to be New NIH Director
On July 8, President Barack Obama announced that he will nominate Francis S. Collins, MD, PhD, as the Director of the NIH.

---

Update on Congressional Health Care Reform Activities
On July 14, leadership from the House Energy and Commerce, Ways and Means, and Education and Labor Committees introduced health care reform legislation, “America’s Affordable Health Choices Act of 2009” (H.R. 3200).

On July 17, the House Ways & Means and Education & Labor Committees passed the bill out of committee. The House Energy & Commerce Committee resumes consideration today, and the legislation is expected to go to the House floor for a full vote before Congress leaves for recess on July 31. ASCO is currently analyzing the 1,100 page bill and will report on elements significant to oncology in a future issue of Cancer Policy Today.

In the Senate, the Health, Education, Labor and Pensions (HELP) Committee passed its own health reform proposal on July 15, and the Finance Committee also is drafting a health reform proposal. The bills will be merged on the Senate floor to create the final Senate health reform bill.

ASCO will continue to keep you up to date on the latest developments in the health care reform debate. For more information, contact ASCO's Cancer Policy & Clinical Affairs Department at 571-483-1670 or publicpolicy@asco.org.

Update on Proposed Medicare Fee Schedule Cuts
ASCO is continuing to hear from oncology practices across the country about how the proposed 6 percent cut to Medicare payments for medical oncology services will have a devastating impact on their ability to provide care to patients. We share your concerns about the adverse impact these cuts will have on the delivery of cancer care in this country.

ASCO is calling on Congress and CMS to fix this untenable situation. The cancer community cannot sustain further payment reductions at a time when the number of people with cancer is increasing, practice expenses continue to rise, and the oncology workforce is dwindling.

As you consider the effects that these payments cuts will have on your practice and your patients, please share your specific feedback with us. Please send any comments you would like to share to publicpolicy@asco.org. ASCO will communicate these comments to CMS and Congress.

ASCO will provide more information on specific actions being taking later this week.

FY 2010 Appropriations Update for NIH and FDA
On July 10, the House Appropriations Labor-HHS-Education Subcommittee approved a FY 2010 spending bill that would give NIH a $942 million funding increase from FY 2009. The full House Appropriations Committee passed the bill out of committee on July 17 by voice vote. The funding amount allocated for NIH is $31.3 billion, which is $500 million above the President’s request and $942 million above FY 2009 funding levels.

On July 7, the Senate Appropriations Committee approved a $300 million budget increase for the Food and Drug Administration (FDA). With user fee revenues included, FDA’s budget would be nearly $3 billion. This budget does not include any funding or user fees that FDA would receive to regulate tobacco products.

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

ASCO Study Finds Varying Interpretation of HIPAA Privacy Rule Can Delay Cancer Research
On July 20, ASCO published a new study in the Journal of Clinical Oncology that shows that research sites differ in compliance with federal requirements contained in the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, and that these differences can result in delays to important research projects.

The study also outlines measures that institutions can take to resolve these differences and speed the pace of research. The study results will be published online today in the Journal of Clinical Oncology.

The disagreements in interpreting the rule were seen most clearly in defining “future research use” of protected health information contained in biospecimen and data repositories, and in the authorization waiver standards for disclosure.

The U.S. Department of Health and Human Services (HHS) implemented the HIPAA Privacy Rule in 2003 to protect the privacy of individuals’ health information. However, ASCO members have experienced situations in which the rule has slowed, or even blocked, certain types of studies that would benefit patients with cancer and survivors.

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

ASCO Comments on Conflict of Interest in Federally Funded Research
On July 2, ASCO sent comments to the National Institutes of Health (NIH) on potential changes to federal regulations addressing financial conflicts of interest in federally funded research. NIH posed a number of questions on these potential changes in its May 8 Advance Notice of Proposed Rulemaking.

The existing regulations, issued in 1995, were designed to promote research objectivity, by establishing standards to ensure there would be no reasonable expectation that the design, conduct, or reporting of funded research will be biased by any conflicting financial interest on the part of the researcher.

ASCO adopted its conflict of interest policy in 1994 and was one of the first medical professional societies to formally address this issue.

ASCO’s comments to NIH include support for:

• The principles outlined by NIH, which are consistent with ASCO’s position that the combined efforts of academic researchers and industry help facilitate the delivery of new drugs, devices, and therapies from laboratories to patients.
  
• Standardization of disclosure requirements.
  
• Development of timely and efficient conflict of interest management mechanisms that permit the participation of experts where appropriate.

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

ASCO Comments on Risk Management Strategy for Prescription Opioids
On June 30, ASCO sent comments to FDA on its Risk Evaluation and Mitigation Strategy (REMS) for extended-release prescription opioids. The FDA requested this input in an April 20 Federal Register notice.

While ASCO supports the Agency’s efforts to address the problems of abuse, misuse and drug poisoning, ASCO is concerned that if not carefully constructed, the REMS could: impede access to opioids for cancer patients; create unwarranted administrative burdens for patients and physicians; and stigmatize the oncologists who prescribe opioids and the cancer patients who take them.

ASCO’s comments on proposed opioid REMS included the following suggestions to mitigate the inappropriate use of opioids:

• Implementation of a National All Scheduled Prescription Electronic Reporting Schedule (NASPERS).
  
• Collaborate with DEA and the various manufacturers to implement a single web-based system of electronic modules for all provider documentation and physician/patient education.
  
• Assess current state opioid management programs, in order to build on the successes of these programs and avoid repeating the failures.
  
• Inclusion of schedule III opioids in the REMS.
  
• Establish metrics and an evaluation plan that will measure the success or failure of the opioid REMS, to ensure that the REMS does not have the unintended consequence of increasing the under-treatment of pain for cancer patients and that the program is successful in addressing abuse, misuse and drug poisoning issues.

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

ASCO Comments on Meaningful Use of EHRs
On June 26, ASCO sent comments to the National Coordinator for Health Information Technology at HHS on the “meaningful use” of electronic health records (EHRs).

The American Recovery and Reinvestment Act authorizes CMS to provide financial incentives for eligible physicians who use EHRs, but physicians who have not proven they are a “meaningful user” by 2015 will face reductions in their Medicare payments, starting with a one percent cut.

ASCO was concerned that since there are no qualifying measures relevant to oncology, it is unknown how an oncologist would qualify for the incentive. Oncology’s special functional requirements have not been taken into consideration. Currently, there is no certification for oncology-specific EHR products, and there is a dearth of certified products on the market.

ASCO joined 76 other health and medical organizations in sending comments to the National Coordinator for Health Information Technology in the U.S. Department of Health and Human Services.

The joint comments state that widespread adoption of health information technology will transform the practice of medicine and provide physicians with a powerful tool by putting real-time, clinically relevant patient information and up-to-date clinical decision support tools in practitioners’ hands at the point of care.

In the comments, the organizations submitted a proposal for defining “meaningful use” of EHRs, which includes:

• Guiding principles that are critical to achieving the goal of widespread adoption of EHRs and other health information technology and to ensuring patient access to quality and timely care.
  
• An achievable and predictable pathway toward meaningful use, including a set of program specifications for meeting the 2011 incentive payment timeframe and beyond.

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

Revisions to the Electronic Prescribing Incentive Program
According to the Medicare Physician Fee Schedule, the Centers for Medicare and Medicaid Services (CMS) is proposing to simplify reporting requirements for its electronic prescribing measure and provide eligible professionals with more reporting options in 2010.

Originally, in order to qualify for the e-prescribing bonus, eligible professionals had to successfully report that they e-prescribed, or attempted to e-prescribe, at least 50 percent of all eligible claims. Under the proposed rule for 2010, eligible professionals have to report that they successfully e-prescribed at least 25 times during the reporting period to be considered a successful electronic prescriber.

In addition to the current claims-based reporting mechanism, e-prescribers would be allowed to report the measure through qualified registries or through a qualified EHR product. Only registries and EHR products that qualify for the 2010 PQRI and have the capability to report the e-prescribing measure could submit data on the e-prescribing measure for 2010.

Physicians must still meet the basic requirement to have at least 10 percent of total Medicare Part B payments come from a list of 33 office-based service codes. After 2013, the bonus program will be phased out, and eligible professionals who do not adopt e-prescribing will face penalties.

CMS will continue to allow computer-generated faxes to count toward e-prescribing under the proposed rule, an exception currently set to be eliminated in 2012. For more information about the e-prescribing incentive, visit ASCO’s Web site.

NCI Requests Feedback on Round 3 Modules for Case Report Form Harmonization/Standardization
As previously reported, NCI is taking part in an effort to standardize and harmonize case report forms. Sections of the case report forms are compiled as modules with different modules being reviewed in each Round. Currently, NCI is requesting feedback on Round 3 Modules.

ASCO encourages those involved in research to provide their feedback to NCI. The review period for this content will conclude by close of business August 5. Send any comments on the "Multi Tab Reviewer Form" to Riki Ohira by this time.


Obama Will Nominate Francis S. Collins, MD, PhD, as New NIH Director
On July 8, President Barack Obama announced that he will nominate Francis S. Collins, MD, PhD, as Director of the NIH.

Dr. Collins, who led the Human Genome Project for nearly a decade, is a leading geneticist known for discovering genes responsible for a wide range of common diseases, including Type 2 diabetes. He also served previously as director of the National Human Genome Research Institute.

If confirmed by the Senate, Collins will oversee a $30 billion budget at the NIH, which is comprised of 27 separate institutes and centers.


News and Notes
Participate in QOPI and the QOPI Certification Program
ASCO recently announced the QOPI® Certification Program, a new 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.

CDC Announces Environmental Public Health Tracking Network
The Centers for Disease Control (CDC) launched a new web-based tool that unites vital environmental information from across the country, including air and water pollutants and information for some chronic conditions, including cancer into one resource. For more information please visit the Tracking Network at www.cdc.gov/ephtracking.

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.