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Medicare Payments for Drugs Used To Treat Wet Age Related Macular Degeneration
WHY WE DID THIS STUDYWet age-related macular degeneration (AMD), a leading cause of vision loss in people aged 60 and older, affects millions of Americans. Lucentis is a Medicare Part B-covered drug approved by the Food and Drug Administration (FDA) for the treatment of wet AMD. Avastin is a Part B-covered drug approved by FDA for the treatment of various forms of cancer, but smaller doses of the drug are being used off-label to treat wet AMD. A dose of Avastin used to treat wet AMD costs a small fraction of the cost of a dose of Lucentis. CMS established a national Medicare payment amount for Lucentis; however, there is no national Medicare payment amount for Avastin when used to treat wet AMD in a physician’s-office setting. In 2010, combined Part B expenditures for Lucentis and Avastin totaled nearly $2 billion.HOW WE DID THIS STUDYUsing Medicare claims data, we selected 2 stratified random samples: 1 sample of 160 physicians who received Medicare payment for Lucentis and 1 sample of 160 physicians who received Medicare payment for Avastin. We sent electronic surveys asking physicians to provide the total dollar amount and quantity purchased of Lucentis and Avastin in the first quarter of 2010. We also asked physicians to describe the factors that they consider when choosing Avastin instead of Lucentis for the treatment of wet AMD. We compared physician acquisition costs to Medicare payment amounts obtained from CMS and Medicare contractors. Additionally, we analyzed Medicare contractor payment policies and the reasons physicians reported for administering Avastin instead of Lucentis.WHAT WE FOUNDIn the first quarter of 2010, physician acquisition costs for Lucentis and Avastin were 5 and 53 percent below the Medicare payment amount, respectively. Medicare contractors’ payment amounts for Avastin when used to treat wet AMD differed by as much as 28 percent, although payment policies were similar. Additionally, we found that the majority of physicians who administered Avastin to treat wet AMD reported the substantial cost difference compared to Lucentis as a primary factor in their decision.WHAT WE RECOMMENDWe recommend that CMS:
(1) Establish a national payment code for Avastin when used for the treatment of wet AMD and(2) Educate providers about the clinical and payment issues related to Lucentis and Avastin.
CMS did not concur with our first recommendation at this time but did concur with our second recommendation.
Treatment for Glaucoma: Comparative Effectiveness
Treatment for Glaucoma: Comparative Effectiveness (PDF)
Source: Agency for Healthcare Research and Quality
Objectives. Glaucoma is a leading cause of visual impairment and blindness worldwide. Treatment focuses on the reduction of intraocular pressure (IOP), which secondarily prevents worsening of visual field loss; in this way, available treatments may prevent visual impairment and blindness. The objective of this Comparative Effectiveness Review is to summarize the evidence regarding the safety and effectiveness of medical, laser, and other surgical treatments for open-angle glaucoma in adults.
Data Sources. We searched MEDLINE®, Embase, LILACS, and CENTRAL through October 6, 2011 to identify clinical trials. We searched MEDLINE and CENTRAL (from 2009 to March 2, 2011) and screened an existing database to identify relevant systematic reviews.
Review Methods. Two reviewers independently assessed citations for eligibility. One reviewer assessed the risk of bias and extracted descriptions of the study. A second reviewer verified the data. Two reviewers also screened the results for systematic reviews. Details about the eligible systematic reviews were abstracted, including elements related to the methodological rigor.
Results. We identified 23 systematic reviews. Twelve reviews addressed medical treatments, 9 addressed surgical treatment, and 1 compared medical versus surgical treatments. One review addressed different surgical treatments as well as medical versus surgical treatments. We identified 73 RCTs and 13 observational studies addressing adverse effects. We identified no studies that evaluated treatments with regard to their impact on visual impairment. We also found insufficient evidence comparing treatment versus no treatment on patient-reported outcomes. No studies addressed the possible link between intermediate outcomes (IOP, optic nerve structure, or visual field) and visual impairment or patient-reported outcomes. There is moderate evidence that medical and surgical treatments can lower IOP and reduce the risk of progression by both visual field and optic nerve criteria. Among medical treatments, the prostaglandin agents are superior to other classes with regard to lowering IOP. While laser trabeculoplasty decreases IOP, the technology used does not make a difference in pressure lowering. With regard to incisional surgeries, trabeculectomy provides more pressure lowering than the class of nonpenetrating procedures. As expected, incisional surgeries produce more significant side effects than do medical treatments.
Conclusions. We did not find evidence addressing direct or indirect links between glaucoma treatment and visual impairment or patient-reported outcomes. This should be an area of focus in future trials of adequate size and duration to detect differences between treatment groups. However, we did find that a number of medical and surgical treatments clearly lower IOP and can prevent visual field loss and optic nerve damage. While we found direct comparisons between some treatments, there are significant gaps in our knowledge of comparative effectiveness.
Quieter Cars and the Safety of Blind Pedestrians, Phase 2: Development of Potential Specifications for Vehicle Countermeasure Sounds — Final Report
Quieter Cars and the Safety of Blind Pedestrians, Phase 2: Development of Potential Specifications for Vehicle Countermeasure Sounds — Final Report (PDF)
Source: National Highway Traffic Safety Administration
This project performed research to support the development of potential specifications for vehicle sounds, (i.e., audible countermeasures) to be used in vehicles while operating in electric mode in specific low speed conditions. The purpose of the synthetic vehicle sound is to alert pedestrians, including blind pedestrians, of vehicle presence and operation. The project developed various options and approaches to specify vehicle sounds that could be used to provide information at least equivalent to the cues provided by ICE vehicles, including speed change. Acoustic data from a sample of ICE vehicles was used to determine the sound levels at which synthetic vehicle sounds, developed as countermeasures, could be set. Psychoacoustic models and human-subject testing were used to explore issues of detectability, masking, and recognition of ICE-like and alternative sound countermeasures. Data were used to develop potential options that could be pursued to develop specifications for synthetic vehicle sounds. Project results indicate that vehicle detectability could potentially be met through various options including: recording(s) of actual ICE sounds; synthesized ICE-equivalent sounds; alternative, non-ICE-like sounds designed for detectability; and a hybrid of the options listed above.
Self-Reported Visual Impairment Among Persons with Diagnosed Diabetes — United States, 1997–2010
Self-Reported Visual Impairment Among Persons with Diagnosed Diabetes — United States, 1997–2010
Source: Morbidity and Mortality Weekly Report (CDC)
Diabetes can lead to visual impairment (VI) and blindness (1). However, early detection and treatment of many common eye diseases, such as diabetic retinopathy and glaucoma, can reduce the risk for developing VI (1). Surveillance of VI among persons with diabetes is important for evaluating the effectiveness of efforts to reduce VI and other complications of diabetes. To examine trends in the prevalence of self-reported VI among adults (persons aged ≥18 years) with diagnosed diabetes in the United States and to assess reported access to eye-care providers, CDC analyzed 1997–2010 data from the National Health Interview Survey (NHIS). This report describes the results of that analysis, which indicated that although the number of adults with diagnosed diabetes reporting VI increased, the age-adjusted percentage of adults with diagnosed diabetes who reported VI declined significantly, from 23.7% in 1997 to 16.7% in 2010. During this 14-year period, age-adjusted VI prevalence declined significantly among most categories of adults with diabetes: men, women, whites, Hispanics, those with some college or higher education, and those diagnosed with diabetes for ≥3 years. Prevalence also declined among those aged ≥45 years. The percentage of adults with diagnosed diabetes and self-reported VI who reported having consulted an eye-care provider in the past year remained constant at approximately 63%. Continued efforts are needed to sustain and improve the declining trends in self-reported VI and to increase rates of recommended eye examinations in the population with diabetes.
Genomics and the Eye
Genomics and the Eye
Source: New England Journal of Medicine
The eye has had a pivotal role in the evolution of human genomics. At least 90% of the genes in the human genome are expressed in one or more of the eye’s many tissues and cell types at some point during a person’s life. Consistent with this impressive genomic footprint is the observation that about a third of entries in the Online Mendelian Inheritance in Man database for which a clinical synopsis is provided include a term that refers to the structure or function of the eye. Moreover, the phenotypic effects of even small genetic variations are made readily apparent by the many layers of amplification in the human visual system. For example, a single-nucleotide change in PAX6 can cause an anatomic abnormality of the macula less than a millimeter in diameter that results in noticeably reduced visual acuity and nystagmus.
The heritable inability to correctly perceive the color green, known as Daltonism (after the English chemist John Dalton, who himself was affected), was the first human trait mapped to the X chromosome. The Coppock cataract was the first human trait mapped to an autosome, and Leber’s hereditary optic neuropathy was the first human disease shown to be caused by a mutation in mitochondrial DNA. More recently, age-related macular degeneration (AMD) and glaucoma — two common causes of human blindness — have been shown to be largely genetic, as has Fuchs’ endothelial dystrophy,8 the most common cause of corneal transplantation in developed countries. Here, we review discoveries in mendelian and complex ophthalmic disorders and their implications for genetic testing and therapeutic intervention.
Severe Hearing Impairment Among Military Veterans — United States, 2010
Severe Hearing Impairment Among Military Veterans — United States, 2010
Source: Morbidity and Mortality Weekly Report (CDC)
A substantial proportion of hearing loss in the United States is attributable to employment-related exposure to noise (1). Among military veterans, the most common service-connected disabilities are hearing impairments (2), suggesting that occupational noise exposure during military service might cause more veterans to have hearing loss than nonveterans. However, a recent analysis of data from the 1993–1995 Epidemiology of Hearing Loss Study did not find significant differences between the two groups (3). To further investigate hearing loss among veterans, specifically the prevalence of severe hearing impairment (SHI), data from the 2010 Annual Social and Economic Supplement (ASEC) to the Current Population Survey (CPS) were analyzed. This report describes the results of those analyses, which indicated that the prevalence of SHI among veterans was significantly greater than among nonveterans. Veterans were 30% more likely to have SHI than nonveterans after adjusting for age and current occupation, and veterans who served in the United States or overseas during September 2001–March 2010, the era of overseas contingency operations (including Operations Enduring Freedom and Iraqi Freedom), were four times more likely than nonveterans to have SHI. These findings suggest a need for increased emphasis on improving military hearing conservation programs (HCPs) and on hearing loss surveillance in military and veterans’ health systems.
Smoking and Visual Impairment Among Older Adults With Age-Related Eye Diseases
Smoking and Visual Impairment Among Older Adults With Age-Related Eye Diseases
Source: Preventing Chronic Disease (CDC)
Smoking is linked to self-reported visual impairment among older adults with age-related eye diseases, particularly cataract and age-related macular degeneration. Longitudinal evaluation is needed to assess smoking cessation’s effect on vision preservation.
Ocular Toxocariasis — United States, 2009–2010
Ocular Toxocariasis — United States, 2009–2010
Source: Morbidity and Mortality Weekly Report (CDC)
Ocular toxocariasis (OT) is caused by the zoonotic parasites Toxocara canis and Toxocara cati, roundworms of dogs and cats. Persons become infected with Toxocara when they unintentionally ingest embryonated eggs that have been shed in the feces of infected animals. Although OT is uncommon, it most often affects young children and can cause debilitating ophthalmologic disease, including blindness. Previous studies of OT in the United States have been conducted in single institutions (1–4). This report describes the results of a web-based survey distributed to uveitis, retinal, and pediatric ophthalmology specialists nationwide to collect epidemiologic, demographic, and clinical information on patients with OT. A total of 68 patients were newly diagnosed with OT from September 2009 through September 2010. Among the 44 patients for whom demographic information was available, the median patient age was 8.5 years (range: 1–60 years), and 25 patients (57%) lived in the South at the time of diagnosis. Among 30 patients with reported clinical data, the most common symptom was vision loss, reported by 25 (83%) patients; of these, 17 (68%) suffered permanent vision loss. The results of this first national level survey demonstrate that OT transmission continues to occur in the United States, frequently affecting children and causing permanent vision loss in the majority of reported patients. Good hygiene practices, timely disposal of pet feces, and routine deworming of pets are strategies necessary to reduce OT in humans.
New From the GAO
New GAO Reports, Correspondence and Testimonies (PDFs)
Source: Government Accountability Office
Reports
1. Deaf and Hard of Hearing Children: Federal Support for Developing Language and Literacy. GAO-11-357, May 25.
http://www.gao.gov/products/GAO-11-357
Highlights – http://www.gao.gov/highlights/d11357high.pdf
2. Defense Management: Comprehensive Cost Information and Analysis of Alternatives Needed to Assess Military Posture in Asia. GAO-11-316, May 25.
http://www.gao.gov/products/GAO-11-316
Highlights – http://www.gao.gov/highlights/d11316high.pdf
3. Smithsonian Institution: Much Work Still Needed to Identify and Repatriate Indian Human Remains and Objects. GAO-11-515, May 25.
http://www.gao.gov/products/GAO-11-515
Highlights – http://www.gao.gov/highlights/d11515high.pdf
Correspondence
1. Federal Student Loans: Patterns in Tuition, Enrollment, and Federal Stafford Loan Borrowing Up to the 2007-08 Loan Limit Increase. GAO-11-470R, May 25.
http://www.gao.gov/products/GAO-11-470R
Testimonies
1. Tax Refunds: Enhanced Prerefund Compliance Checks Could Yield Significant Benefits, by Michael Brostek, director, strategic issues, before the Subcommittee on Oversight, House Committee on Ways and Means. GAO-11-691T, May 25.
http://www.gao.gov/products/GAO-11-691T
Highlights – http://www.gao.gov/highlights/d11691thigh.pdf
2. Taxes and Identity Theft: Status of IRS Initiatives to Help Victimized Taxpayers, by James R. White, director, strategic issues, before the Subcommittee on Fiscal Responsibility and Economic Growth, Senate Committee on Finance. GAO-11-674T, May 25.
http://www.gao.gov/products/GAO-11-674T
Highlights – http://www.gao.gov/highlights/d11674thigh.pdf
3. Opportunities to Reduce Potential Duplication in Government Programs, Save Tax Dollars, and Enhance Revenues, by Gene L. Dodaro, comptroller general of the United States, before the Senate Committee on Homeland Security and Governmental Affairs. GAO-11-635T, May 25.
http://www.gao.gov/products/GAO-11-635T
4. Economic Development: Efficiency and Effectiveness of Fragmented Programs Are Unclear, by William B. Shear, director, financial markets and community investment, before the House Committee on Small Business. GAO-11-651T, May 25.
http://www.gao.gov/products/GAO-11-651T
5. Antidumping and Countervailing Duties: Options for Improving Collection, by Loren Yager, director, international affairs and trade, before the Subcommittee on Homeland Security, Senate Committee on Appropriations. GAO-11-693T, May 25.
http://www.gao.gov/products/GAO-11-693T
Highlights – http://www.gao.gov/highlights/d11693thigh.pdf
Reasons for Not Seeking Eye Care Among Adults Aged ≥40 Years with Moderate-to-Severe Visual Impairment — 21 States, 2006–2009
Reasons for Not Seeking Eye Care Among Adults Aged ≥40 Years with Moderate-to-Severe Visual Impairment — 21 States, 2006–2009
Source: Morbidity and Mortality Weekly Report (CDC)
In 2000, an estimated 3.4 million U.S. residents aged ≥40 years were blind or visually impaired (1). Vision problems place a substantial burden on individuals, caregivers, health-care payers, and the U.S. economy, with the total cost estimated at $51.4 billion annually (2). Although regular comprehensive eye examinations are essential for timely treatment of eye disease to maintain vision health, a previous study has shown that substantial percentages of persons do not seek eye care, despite having visual impairment (3). To ascertain why adults aged ≥40 years with moderate-to-severe visual impairment did not seek eye care in the preceding year, CDC analyzed data for 21 states from 2006–2009 Behavioral Risk Factor Surveillance System (BRFSS) surveys. This report summarizes the results of that analysis, which found that eye-care cost or lack of insurance (39.8%) and perception of no need (34.6%) were the most common reasons given for not seeking eye care. Among those aged 40–64 years, cost or lack of health insurance was the most common reason (42.8%); among those aged ≥65 years, the most common reason was no need (43.8%). Identifying the reasons for unmet eye-care needs might enable development of targeted interventions to improve vision health among those with moderate-to-severe visual impairment.
