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Urology Subcommittee Meeting SummaryKidney, Urologic, and Hematologic Diseases Interagency Coordinating Committee (KUHICC) Members Present: NIDDKNINRAHCPRNIHNCINCRR J. Briggs (chair)C. Rodgers (executive secretary)N. ArmstrongS. FoxD. McDonaldS. TaubeD. Wilde Alternates Present: FDANICHHD H. HerreraV. NimmagaddaM. McClure Dr. Josephine Briggs, Director of the Division of Kidney, Urologic, and Hematologic Diseases, welcomed the attendees and introduced the guest speaker, Dr. Grant Bagley, Director of the Coverage and Analysis Group at the Health Care Financing Administration (HCFA). Dr. Bagley was invited to discuss HCFA coverage of urologic services. He stated that, in general, it is very difficult to develop coverage policies for urology procedures. Dr. Bagley described Medicare as a 33-year-old health insurance program for people over the age of 65, the chronically disabled, and end-stage renal disease patients. He explained Medicare's method of determining coverage of services: a covered service must fall into one of the statutorily defined "benefit categories" and satisfy HCFA's process for determining whether the treatment is "reasonable and necessary." He gave several examples of statutorily covered services, including prosthetic devices, the chiropractic procedure of subluxation of the spine when indicated by x-ray, and screening for colorectal cancer. Routine eye examinations and cosmetic surgery are examples of services that are not currently covered. HCFA's reviews will remain evidence-based, with emphasis on demonstrated medical effectiveness and improved health outcomes. HCFA also considers whether benefits outweigh reasonable anticipated risks. Dr. Bagley explained that Medicare coverage is both a medical and political program that is changing its process to make it more understandable and responsive to beneficiaries. This new process will be outlined in the Federal Register. Dr. Bagley explained the difference between Food and Drug Administration review and HCFA review. FDA reviews products to determine their safety and effectiveness, while HCFA determines whether treatments are reasonable and necessary to diagnose and treat disease. FDA approval is concerned with short-term or immediate effects of the product; HCFA concentrates on broader and long-term effects on patients. HCFA takes into consideration the setting or location where the treatment will take place and also assesses the level of the technology. The Medicare statute, Dr. Bagley noted, has prohibited coverage of preventive services such as bone density marrow scans for osteoporosis and prostate-specific antigen tests for cancer. Congress recently passed new legislation, however, that allows Medicare coverage of these types of services. Mammography and colorectal cancer screening are preventive services that have also been included in Medicare. Medicare has local carrier contracts with companies that administer the program for both inpatient and outpatient services. Medicare processes 1 billion claims per year at an average cost of 68 cents per claim. Carriers write policies that are submitted to a carrier advisory committee and, after being published for 45 days, take effect. Coverage varies around the country. If a procedure is not paid for and there are complaints, a final decision is made by the carrier. HCFA relies in part on FDA findings to determine coverage. Confusion regarding payment for lung reduction surgery prompted HCFA to investigate controlled research studies in this area. After it was found that evidence was insufficient to make a coverage decision, the recommendation was to fund additional clinical trials. As a rule, HCFA does not pay for procedures when there are insufficient clinical data to support their effectiveness. Coverage of microwave treatment for benign prostatic hyperplasia is left to the carrier's discretion; transurethral needle ablation is not reimbursed at this time. Dr. Bagley discussed Medicare's stand on reimbursement for drugs. Medicare does not pay for drugs that can be self-administered, except for agents for cancer. Testosterone suppression drugs to treat prostate cancer are covered. Medications that produce similar desired effects are often not priced identically; the wholesale prices can be found in the "red book." In the case of Lupran and Zoladex, nearly identical drugs, Medicare will pay only for the less costly Zoladex. Medication coverage was adapted from the policy designed for equipment such as wheelchairs, which states that Medicare will pay for the least costly alternative. Payments to physicians are relative and reimbursed according to a uniform schedule. Payments are based on the physician's work effort, practice expense, and malpractice insurance expense. The physician's work is assessed differently for every procedure, and such factors as stress and time are taken into account. The schedule is updated annually and reviewed completely every 5 years. Dr. Bagley explained that Medicare currently has two parts, A and B. Part A, made up of funds from the Medicare trust fund, pays for inpatient services for Medicare beneficiaries. Part B, for physician's services and other services such as outpatient laboratory tests, is paid through optional premiums. Dr. Bagley also discussed biofeedback for urinary incontinence. HCFA would approve it if there were evidence that it is effective and can be controlled. There are many unresolved issues regarding its benefits, monitoring the number of treatments, and delivery mechanisms in controlled settings such as long-term care facilities. Licensed physical therapists, particularly, are promoting coverage of the procedure. While biofeedback is reimbursed in limited situations, such as neuromuscular problems, a detailed policy needs to be established for its use for urinary incontinence. In a similar issue unrelated to urology, physical therapists are pressing for coverage of electrical stimulation for the treatment of decubitus ulcers. While studies have shown this therapy to be effective, Dr. Bagley noted that it is not more effective than not using electrical stimulation and that HCFA has not agreed to pay for it. Much interest is being expressed in the area of impotence. Dr. Bagley indicated that HCFA covers work-ups, surgical implants, and the initial injection of papaverine (given by the physician with accompanying instructions for use) but does not pay for in-home injections. Dr. Bagley discussed CPT codes, which are the basis for physician reimbursement and are owned by the American Medical Association (AMA). Determined by advisory committees of AMA members with minimal input from HCFA, they are reviewed every 5 years for their efficacy. In certain instances HCFA will develop additional codes. Dr. Briggs asked attendees to report on activities at their agencies. She mentioned her interest in forming a cooperative partnership between HCFA and NIH to identify strategies in urological services. She also indicated that another Urology Subcommittee meeting will be held in 3 to 4 months with a guest speaker. The two main urology initiatives for next year are urinary incontinence and an epidemiological survey on urological health databases. Dr. Armstrong (NINR) stated that her institute is particularly interested in funds for the issue of urinary incontinence. Dr. Steve Fox (AHCPR) mentioned that his agency continues to work on prostate disease and cancer projects. Dr. Sheila Taube (NCI) mentioned that the prostate cancer research report will be finalized in September and, at Dr. Briggs' request, an executive summary will be distributed to coordinating committee members. NCI is also working on developing an initiative on translational research. Dr. Michael McClure (NICHHD) is reviewing the proposals submitted for research on women's health. Forty-two applications have been submitted, but funds are available for only 10 grants. Dr. Daniel McDonald (NIH) reported on progress made by community interaction and the urology special emphasis panel. Dr. V-Roa Nimmagadda (FDA) reported on the progress being made by Congress and FDA to pass funding for orphan drugs and devices based on probable benefits identified by the target populations. Target populations must be less than 4,000. Dr. David Wilde (NCRR) indicated that he is working on bringing under one umbrella Clinical Research Centers in 75 universities around the country. In closing, Dr. Briggs announced two workshops: one on prostate disease in minorities and another on oxalosis and urinary tract stone disease. She is also working on establishing an e-mail service and a Web site for the coordinating committee.
Dr. Josephine Briggs, Director of the Division of Kidney, Urologic, and Hematologic Diseases, welcomed the attendees and introduced the guest speaker, Dr. Grant Bagley, Director of the Coverage and Analysis Group at the Health Care Financing Administration (HCFA). Dr. Bagley was invited to discuss HCFA coverage of urologic services. He stated that, in general, it is very difficult to develop coverage policies for urology procedures.
Dr. Bagley described Medicare as a 33-year-old health insurance program for people over the age of 65, the chronically disabled, and end-stage renal disease patients. He explained Medicare's method of determining coverage of services: a covered service must fall into one of the statutorily defined "benefit categories" and satisfy HCFA's process for determining whether the treatment is "reasonable and necessary." He gave several examples of statutorily covered services, including prosthetic devices, the chiropractic procedure of subluxation of the spine when indicated by x-ray, and screening for colorectal cancer. Routine eye examinations and cosmetic surgery are examples of services that are not currently covered. HCFA's reviews will remain evidence-based, with emphasis on demonstrated medical effectiveness and improved health outcomes. HCFA also considers whether benefits outweigh reasonable anticipated risks. Dr. Bagley explained that Medicare coverage is both a medical and political program that is changing its process to make it more understandable and responsive to beneficiaries. This new process will be outlined in the Federal Register.
Dr. Bagley explained the difference between Food and Drug Administration review and HCFA review. FDA reviews products to determine their safety and effectiveness, while HCFA determines whether treatments are reasonable and necessary to diagnose and treat disease. FDA approval is concerned with short-term or immediate effects of the product; HCFA concentrates on broader and long-term effects on patients. HCFA takes into consideration the setting or location where the treatment will take place and also assesses the level of the technology.
The Medicare statute, Dr. Bagley noted, has prohibited coverage of preventive services such as bone density marrow scans for osteoporosis and prostate-specific antigen tests for cancer. Congress recently passed new legislation, however, that allows Medicare coverage of these types of services. Mammography and colorectal cancer screening are preventive services that have also been included in Medicare.
Medicare has local carrier contracts with companies that administer the program for both inpatient and outpatient services. Medicare processes 1 billion claims per year at an average cost of 68 cents per claim. Carriers write policies that are submitted to a carrier advisory committee and, after being published for 45 days, take effect. Coverage varies around the country. If a procedure is not paid for and there are complaints, a final decision is made by the carrier. HCFA relies in part on FDA findings to determine coverage. Confusion regarding payment for lung reduction surgery prompted HCFA to investigate controlled research studies in this area. After it was found that evidence was insufficient to make a coverage decision, the recommendation was to fund additional clinical trials. As a rule, HCFA does not pay for procedures when there are insufficient clinical data to support their effectiveness. Coverage of microwave treatment for benign prostatic hyperplasia is left to the carrier's discretion; transurethral needle ablation is not reimbursed at this time.
Dr. Bagley discussed Medicare's stand on reimbursement for drugs. Medicare does not pay for drugs that can be self-administered, except for agents for cancer. Testosterone suppression drugs to treat prostate cancer are covered. Medications that produce similar desired effects are often not priced identically; the wholesale prices can be found in the "red book." In the case of Lupran and Zoladex, nearly identical drugs, Medicare will pay only for the less costly Zoladex. Medication coverage was adapted from the policy designed for equipment such as wheelchairs, which states that Medicare will pay for the least costly alternative.
Payments to physicians are relative and reimbursed according to a uniform schedule. Payments are based on the physician's work effort, practice expense, and malpractice insurance expense. The physician's work is assessed differently for every procedure, and such factors as stress and time are taken into account. The schedule is updated annually and reviewed completely every 5 years.
Dr. Bagley explained that Medicare currently has two parts, A and B. Part A, made up of funds from the Medicare trust fund, pays for inpatient services for Medicare beneficiaries. Part B, for physician's services and other services such as outpatient laboratory tests, is paid through optional premiums.
Dr. Bagley also discussed biofeedback for urinary incontinence. HCFA would approve it if there were evidence that it is effective and can be controlled. There are many unresolved issues regarding its benefits, monitoring the number of treatments, and delivery mechanisms in controlled settings such as long-term care facilities. Licensed physical therapists, particularly, are promoting coverage of the procedure. While biofeedback is reimbursed in limited situations, such as neuromuscular problems, a detailed policy needs to be established for its use for urinary incontinence. In a similar issue unrelated to urology, physical therapists are pressing for coverage of electrical stimulation for the treatment of decubitus ulcers. While studies have shown this therapy to be effective, Dr. Bagley noted that it is not more effective than not using electrical stimulation and that HCFA has not agreed to pay for it.
Much interest is being expressed in the area of impotence. Dr. Bagley indicated that HCFA covers work-ups, surgical implants, and the initial injection of papaverine (given by the physician with accompanying instructions for use) but does not pay for in-home injections.
Dr. Bagley discussed CPT codes, which are the basis for physician reimbursement and are owned by the American Medical Association (AMA). Determined by advisory committees of AMA members with minimal input from HCFA, they are reviewed every 5 years for their efficacy. In certain instances HCFA will develop additional codes.
Dr. Briggs asked attendees to report on activities at their agencies. She mentioned her interest in forming a cooperative partnership between HCFA and NIH to identify strategies in urological services. She also indicated that another Urology Subcommittee meeting will be held in 3 to 4 months with a guest speaker. The two main urology initiatives for next year are urinary incontinence and an epidemiological survey on urological health databases.
Dr. Armstrong (NINR) stated that her institute is particularly interested in funds for the issue of urinary incontinence. Dr. Steve Fox (AHCPR) mentioned that his agency continues to work on prostate disease and cancer projects. Dr. Sheila Taube (NCI) mentioned that the prostate cancer research report will be finalized in September and, at Dr. Briggs' request, an executive summary will be distributed to coordinating committee members. NCI is also working on developing an initiative on translational research.
Dr. Michael McClure (NICHHD) is reviewing the proposals submitted for research on women's health. Forty-two applications have been submitted, but funds are available for only 10 grants. Dr. Daniel McDonald (NIH) reported on progress made by community interaction and the urology special emphasis panel. Dr. V-Roa Nimmagadda (FDA) reported on the progress being made by Congress and FDA to pass funding for orphan drugs and devices based on probable benefits identified by the target populations. Target populations must be less than 4,000. Dr. David Wilde (NCRR) indicated that he is working on bringing under one umbrella Clinical Research Centers in 75 universities around the country.
In closing, Dr. Briggs announced two workshops: one on prostate disease in minorities and another on oxalosis and urinary tract stone disease. She is also working on establishing an e-mail service and a Web site for the coordinating committee.
Page last updated: September 26, 2007
