EYE ON WASHINGTON

House Passes Mammography Quality Standards Reauthorization Act The Mammography Quality Standards Reauthorization Act (MQSA) of 2004 (HR 4555 and S 1879) was unanimously passed by both Houses of Congress. The bill reauthorizes the original MQSA (1992) and is effective until 2007. It was introduced in the House by Rep. John S. Dingell (D-MI) and in the Senate by Sen. Barbara Mikulski (D-MD). The Susan G. Komen Breast Cancer Foundation championed the act, got more than 25,000 petitions signed, submitted letters to Congress, and met with members of Congress. The Foundation, the Institute of Medicine, and the Government Accountability Office are using MQSA as a basis for exploring other key mammography issues such as reader interpretation, data collection and reporting, facility closures, recruitment of radiologists, and reimbursement rates. Komen President and CEO Susan Braun said she is grateful for the wide bipartisan support of the bill, and added that MQSA has played a major role in advancing early detection and saving lives in the past decade. The bill established federal quality standards for personnel, equipment, and operating procedures. Diane Balma, Komen's Director of Public Policy, said that in order to improve MQSA in the future several important issues remain to be addressed: Reader interpretation. There is wide variation in the way radiologists interpret the same mammography film. Congress now has an opportunity to build upon existing quality standards related to image interpretation. Data collection and reporting. Facilities must be able to assess their performance, which should occur through evaluation of medical outcomes data—not now required. In addition, centralized data could provide information about disparities in outcomes for low-income and minority populations. Facility closure, recruitment, and reimbursement. There is a growing shortage of radiologists who specialize in reading mammograms, in part because of low reimbursement rates, and patients face increased waiting times for mammography. Medicare Broadens Coverage for Cancer Care in Two Important Ways In response to complaints from oncologists that Medicare reimburses poorly for services other than provision of chemotherapeutic agents, the Centers for Medicare and Medicaid Services (CMS) has decided to invest $300 million on a demonstration program to determine how cancer patients feel during treatment. CMS will pay oncologists $130 per patient per day if they collect information about pain, nausea and vomiting, and fatigue, three of the conditions that patients find most distressing. The program, which will last for one year, is intended to quell oncologists' arguments that they are not being reimbursed for care provided to enhance patients' quality of life. CMS Administrator Mark B. McClellan, MD, PhD, has offered the fee as reimbursement for non-drug care, but only if the agency gets something in return: data about how well oncologists are providing quality-of-life care. “This is really about developing better evidence,” he said. “We're not just giving doctors more money.” Joseph Bailes, MD, Co-Chairman of ASCO's Government Relations Committee, said that the program is an important recognition that resources have to be available to care for people with cancer. The second departure from hard-and-fast CMS policy involves financing nine clinical trials of approved cancer drugs for nonapproved uses. Ordinarily CMS will reimburse only approved drugs for approved indications. The trials, which are jointly sponsored by CMS and NCI and which are subject to several weeks of public comment, will involve 2,000 to 3,000 people taking Erbitux, Avastin, Camptosar, and Eloxatin for conditions other than colon cancer for which the drugs have been approved. “Our goal is to get fast answers about whether these treatments are beneficial or not,” Dr. McClellan said. Edward Otto Named to Direct FDA Office of Cellular, Tissue, and Gene Therapies Edward Otto, PhD, is the new Director of the FDA Office of Cellular, Tissue, and Gene Therapies in the Center for Biologic Evaluation and Research (CBER). The office, established to consolidate the agency's resources and expertise, plays a central role in regulation of new biologic technology. FDA Acting Commissioner Lester M. Crawford, DVM, said of Dr. Otto: “He was selected from a large and talented pool of applicants because of his outstanding management skills and scientific accomplishments, which include gene therapy product research and development.” Jesse Goodman, MD, CBER Director, said, “Ed is not only a talented scientist and manager, he has been a well-liked leader who has worked effectively within his organization to bring out the best in everyone.” Dr. Otto received a PhD in genetics from the University of North Carolina-Chapel Hill and did post-doctoral work in genetics and molecular biology at UNC and Duke University. He joined Genetic Therapy, Inc. in 1992, ultimately becoming Chief Operating Officer. He became COO of Intronn, Inc. in 2002 where he worked on development of RNA trans-splicing technology. Senate Adopts Resolution Encouraging Physicians to Inform Prostate Cancer Patients about Proven Treatments The Senate passed a resolution, already passed in the House of Representatives, that encourages physicians to inform their prostate cancer patients about all proved treatments. S Res 389 was introduced and sponsored by Sen. Ben Nighthorse Campbell (R-CO) and was co-sponsored by 27 senators in both parties. According to the resolution, the federal government and the states should ensure that health care providers give prostate cancer patients appropriate information and other tools necessary for them to receive understandable descriptions of the advantages, disadvantages, benefits, and risks of all efficacious treatments, including brachytherapy, hormone treatment, external-beam radiation, chemotherapy, surgery, and watchful waiting. “This resolution represents a milestone in educating the public about the full range of treatment options available to prostate cancer patients,” Sen. Campbell said. The CEO and President of Theragenics Corp., which makes TheraSeed, a palladium-103 device, and I-Seed, an iodine-125-based device, M. Christine Jacobs, said in a news release, “It continues our ongoing campaign to increase public awareness of the proven treatments for prostate cancer. Health care professionals have an obligation to provide comprehensive information. Only then will patients be empowered to select the most appropriate therapy. Essential in making that decision is understanding the cure rates and the quality-of-life implications of all approaches.” The company has lobbied Congress in an effort to ensure that the new Medicare prescription drug law reimbursed for brachytherapy and removed financial obstacles that often stood in the way of prescribing as many brachytherapy seeds as required. JCAHO to Increase Survey Fees The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) will increase the organization's triennial survey fees for hospitals this year. The rate hike will be $2,700, up 11.7% over the average survey fee of $23,000 in 2004. For hospitals with 200 beds or more, the JCAHO plans to charge a separate fee of $3,500 to cover the cost of adding a certified health care engineer to the survey team. The engineer will help evaluate hospital compliance with safety code and physical plant requirements, according to a statement released by the organization. This will bring the survey cost of larger hospitals to 29% more than 2004. Seniors May Pay Higher Premiums than Promised under New Medicare Drug Law Rep. Pete Stark (D-CA), Senior Democrat on the Ways and Means Health Subcommittee, has released a report showing that under the new Medicare prescription drug law, senior citizens may be subject to uncertain premiums that will vary significantly state by state and may be significantly higher than the average $35 promised under the law. “This report shows that seniors may pay dramatically different premiums for drug coverage because of where they live,” he said. “This strikes at the heart of Medicare's universal nature, and every effort ought to be made to limit this variation. “The only thing certain about this evolving program is uncertainty,” Rep. Stark continued. “Those who appear to benefit today may not tomorrow. “The bottom line is that the new law offers no protection against price gouging and lets the pharmaceutical industry and private insurance companies decide how much to charge and which drugs are covered.” The report prepared by the subcommittee found that premiums for Medicare beneficiaries could vary by more than 700% based on residence. For example, seniors in Indiana could face the highest potential premiums at more than $50 per person per month, while North Dakota residents could have premiums as low as $7 per person per month. “These premiums are a preview of the cost fluctuations seniors may be forced to bear if we don't fix the flawed and confusing Medicare drug law,” Rep. Stark said. “It's time Congress stopped this impending price discrimination and guarantee that every senior is offered coverage for a reasonable, affordable premium.” ASTRO Commends CMS for Physician Fee Schedule Changes The American Society for Therapeutic Radiology and Oncology congratulated the Centers for Medicare and Medicaid Services (CMS) for accepting many of the Society's recommendations that will allocate more resources to physicians who use radiation therapy to treat cancer. The 2005 final rule, published in the Federal Register in November, includes a 1.5% increase in physician payment rates. In response to concerns about the proposal to change the global period for CPT code 77427, CMS plans to retain the code as “radiation treatment management, five treatments.” CMS also will keep portable x-ray in the nonphysician work pool. If it had been removed, there would have been a negative effect on radiation oncology. CMS thanked ASTRO for providing requested documentation for equipment and supply pricing sources, and it has revised the practice expense database to reflect the information that ASTRO provided. “ASTRO appreciates that CMS took our comments into consideration for this final rule,” said ASTRO Executive Director Laura I. Thevenot. “Since Medicare and Medicaid are the predominant sources for reimbursement for radiation oncology treatments, I believe these changes will help our physicians continue their high quality care.”