At Press Time
ASC Payment Increases Proposed for 2012
CMS also announces new quality reporting program.
By Samantha Stahl, Assistant Editor
■ Physicians can look forward to a 0.9% Medicare payment rate increase for outpatient surgical services at ASCs and a 1.5% increase in hospital outpatient departments (HOPD), thanks to a proposed rule recently released by CMS.
The rule, which is open for public comment until August 31, updates the current payment rate based on the Consumer Price Update: Urban, which is estimated to be +2.3%. For ASCs, this figure then incurs a “productivity adjustment,” as required by healthcare reform legislation, against cost-of-living updates. CMS estimates the adjustment to be 1.4%, which predicts the 0.9% increase in payments.
Though this number will not be finalized until the end of the year, it is higher than the 0.2% increase from last year but is still lower than the calculated increases for HOPDs, a standard that Michael Romansky, JD, Washington counsel for OOSS, called “unsatisfactory” in a recent press release. “The OOSS position remains that ASCs should be provided the same cost-of-living adjustment provided to HOPDs, which is typically about a point higher,” he said.
A favorable outcome of the proposal is that almost all procedures will experience at least a slight rate increase, unlike years past. Though the adjustment is minimal for services like cataract surgery, which will only rise to $952.83 in 2012 from $951 in 2011, some procedures will receive substantial increases. Glaucoma surgery, for example, will increase from $933 in 2011 to $1,002.38 in 2012 and both laser retinal services and vitrectomy will go from $1,586 to $1,639.56.
A new voluntary, confidential ASC quality reporting program will also be unveiled in 2012 and 2013, when facilities will report results on seven to eight designated quality and outcome measures, including patient burns, patient falls in the ASC, wrong site, wrong side, wrong patient, wrong procedure, wrong implant and hospital transfer/admission. The results will be used to determine payment rates for 2014. Any ASC that fails to report will be subject to payment rate reduction in 2014 and thereafter.
CMS will issue a final rule by November 1st of this year.
| Clarification |
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| From the Editor: The June 2011 article “Making a Segue into SEGRAs” discussed mapracorat, an investigational new drug being studied for dry eye by Bausch + Lomb. It is currently in early clinical trials, and it has not been proven to be safe and effective for the treatment of dry eye. Furthermore, there is no clinical evidence that mapracorat is superior to any approved product on the market. While the article was based on an interview with Bausch + Lomb's Chief Medical Officer, Dr. Calvin Roberts, it was not reviewed in accordance with Bausch + Lomb's standard medical, legal and regulatory publication procedure. Therefore, the company and editors of Ophthalmology Management felt it was important to clarify how mapracorat was described in the piece. |
Eye Tests Are Predictive of Alzheimer's
Several promising approaches are now being studied.
■ A growing accumulation of data from researchers in the UK and Australia is indicating that a simple, office-based eye test may be helpful in predicting Alzheimer's Disease (AD) years before a patient presents with symptoms. In addition, a US company is developing an optical scanning technology that could detect the physical signs of AD before these signs would be present in brain scans.
Researchers from London, presenting earlier this year at ARVO, reported a correlation between peripheral hard drusen and AD.
Using the Optos P200C for ultra-wide angle retinal imaging in 55 AD patients and 48 controls, the researchers found peripheral hard drusen in 14 of the AD patients but in only two of the control group.
The researchers wrote that, with further study, pathological changes in the periphery “might become a valuable tool in detecting and monitoring the progression of AD.”
More recently, at an international meeting of Alzheimer's researchers in Paris, Shaun Frost of Australia's national science agency presented a small study that compared retinal photos of 110 healthy subjects, 13 individuals with Alzheimer's and 13 others with mild cognitive impairment who were taking part in a larger study on aging. The widths of certain blood vessels in individuals with Alzheimer's were different from vessels in the others and the amount of difference was equivalent to the amount of plaque seen on brain scans.
A Massachusetts company, Neuroptix, is now developing a non-invasive laser scanning eye test that could be predictive of AD. The test is designed for early detection of beta amyloid proteins in the lens of the eye. These proteins are known to be responsible for the formation of plaques in the brains of Alzheimer's patients.
Neuroptix is partnering with Merck in developing this technology and has already received three rounds of venture capital financing.
Resident Results in Refractive Surgery
How well did they do in performing LASIK?
■ Researchers at the Beaumont Eye Institute in Royal Oak, Mich., sought to measure the performance of residents in performing LASIK procedures, both with and without IntraLase flap creation. To do this, they retrospectively reviewed 65 patients and 130 eyes in LASIK and IntraLase-assisted procedures performed over more than a six-year period.
Of the 130 cases, 60 received LASIK and 66 LASIK with IntraLase. Mean follow-up was 120 days, though individual follow-up time varied greatly.
For all 130 eyes, the mean postop UCVA was 20/22. Seventy-nine percent of eyes had 20/20 vision and 98% had vision of 20/40 or better. In regard to procedure type, the mean UCVA for LASIK was 20/24.09 and 20/20.58 for IntraLase. Eighty percent of eyes with LASIK had 20/20 vision and 97% had vision within 20/40. IntraLase results were 80% of cases within 20/20 and 100% within 20/40. No statistical difference existed in regards to UCVA and type of procedure. Per the spherical equivalent (SE) groups, the number attaining 20/20 UCVA were: hyperopic eyes (n=6) 83%; low myopes (n=39) 77%; moderate myopes (n=70) 82% and high myopes (n=15) 67%. No statistical difference existed in UCVA in respect to a specific SE group. As per complications, there were two slipped flaps, three DLK and two macrostriae. Once these complications were addressed, all patients had 20/40 or better UCVA.
The researchers concluded that resident-performed refractive surgery can be safe and effective.
Addressing Vision Issues of Senior Drivers
Aging boomers are changing cars and highway signage.
By René Luthe, Senior Associate Editor
■ The Baby Boomer generation continues to wield influence as they move into that dreaded category, “older drivers.” By 2030, it's anticipated that one in four drivers will be age 65 or older. Here's what industry, government and medicine are doing to make driving safer for a visually challenged population that is trending older:
► The good news is that driving deaths among the elderly have been trending downward. The Insurance Institute for Highway Safety reports that the number of drivers age 70 and older who died or were involved in fatal car crashes declined in the time period 1997 to 2006 from previous years. According to the IIHS, this reversed a generally increasing trend beginning in the early 1980s and peaking in 1997, when crash deaths for this demographic reached 5,871. Deaths then steadily declined to 4,611 in 2006, representing a 21% reduction from 1997.
The IIHS attributes the decline to an increasing tendency among older drivers to self-limit, choosing not to drive after dark or in bad weather conditions, for instance, as well as better health among the elderly in general and safety features in cars such as air bags and crunch zones. Another significant factor, though, according to the IIHS, is that older drivers today are more educated about the effects of aging on vision and the mental and physical abilities required in driving.
► Carmakers are seeking to help compensate for these physical changes age brings by adding features such as bigger rear-view mirrors, larger readouts on instrument panels, and instrument controls designed for less flexible hands. Ford announced that it will make the font both thicker and bolder in the interiors of its 2013 Ford Explorer and Ford Edge. The change means that wording will be approximately 40% wider on interior display screens and controls. Other models will also receive the font change in coming years, Ford says.
“For the first time,” the company noted in its announcement, “people age 65 and over will outnumber children under the age of five. It's a transformation that's changing the world, along with all kinds of products in it.”
Other car companies recognize this too. Nissan, GM and Daimler are experimenting with “intelligent” highway and car systems that can communicate automatically with each other to regulate traffic and avoid accidents.
► Government is also addressing the challenges older drivers face by making signs easier to read for aging eyes. The Federal Highway Administration recently endorsed a font for signs that increases the distance at which signs are legible for older drivers by 16% (12% for all drivers). Called “Clearview,” the font has been adopted in eight states thus far.
► In the ophthalmology community, the fifth biennial “The Eye and the Auto” conference to be held September 12-14 in Detroit will include presentations on topics such as vision and human factors in vehicle design and operation, and policy issues related to vision and driving.
| In the News … |
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| ■ Insurers err on almost 20% of claims. According to the AMA's annual National Health Insurer Report Card, insurers in 2010 made an error of some kind in the processing of 19.3% of all claims. This represented an increase of 2% in the error rate compared with the previous survey. The increase in overall inaccuracy represents an extra 3.6 million in erroneous claims payments compared to 2009 and added an estimated $1.5 billion in unnecessary administrative costs to the health system. The AMA estimates that eliminating health insurer claim payment errors would save $17 billion. “A 20% error rate among health insurers represents an intolerable level of inefficiency,” said AMA Board Member Barbara McAneny, MD. “Health insurers must put more effort into paying claims correctly the first time to save precious healthcare dollars and reduce unnecessary administrative tasks that take time and resources away from patient care.” ■ LCA-Vision reports procedure volume. LCA-Vision, provider of laser vision correction services under the LasikPlus brand, reported that 14,081 procedures were performed during the second quarter of 2011 in 53 centers. This compares with 15,266 procedures in 62 vision centers during the second quarter of 2010. Same-store procedures increased slightly year-over-year from the second quarter of 2010, the third consecutive quarter of year-over-year same-store procedure growth. ■ Dry eye treatment approved. TearScience, Inc. has received FDA clearance for its LipiFlow Thermal Pulsation System for the treatment of meibomian gland dysfunction (MGD), also known as evaporative dry eye. LipiFlow will be available immediately, but on a limited basis in the US through the end of 2011. LipiFlow removes meibomian gland obstructions by applying directed energy to a patient's eyelid during a 12-minute in-office treatment. Approximately 65% of those afflicted with dry eye are estimated to have evaporative dry eye. Common symptoms include eye irritation, dryness, redness, tiredness and visual disturbances. TearScience's integrated, in-office system addresses the obstructed glands. By assessing the tear film and meibomian gland function, physicians can determine whether MGD is the primary cause of a patient's evaporative dry eye and whether a patient is a good candidate for LipiFlow. TearScience gained FDA clearance by demonstrating the safety and effectiveness of LipiFlow through a nine-center randomized controlled clinical trial. ■ Generic drugmakers shielded from state laws. In a 5 to 4 decision in which conservative members of the US Supreme Court prevailed, the Court determined that generic drug makers have no responsibility to provide new labeling information for their products if new dangers from these drugs come to light. The Court acted after several lawsuits were filed under various state liability laws by individuals who believed the generic drugs they took should have had more extensive warnings as part of their labels. These individuals contended that the lack of a broader warning impaired their health. The Court majority argued that state laws could not apply in these cases because labeling of drugs is decided only by the FDA. Unlike generics, branded drugs must be relabeled if possible new dangers are revealed. ■ Dr. Redmond dies, AAO past president. Michael Redmond, MD, a pediatric ophthalmologist and AAO past president, died in Florida in late June after battling cancer. Dr. Redmond was active in the AAO for many years and was elected president of the organization in 2003. “Mike Redmond's passing is a loss for our entire profession,” Academy CEO and EVP David W. Parke II, MD, said. “He was a national leader for decades in the areas of professionalism, ethics, quality of care, advocacy and practice management. But above all, he was a compassionate, principled and thoroughly decent man. The profession of ophthalmology and all his family and friends will miss him deeply.” ■ Cachet phakic lens has positive study. The angle-supported phakic Alcon Acrysof Cachet demonstrated highly positive results in pooled study data encompassing a total of 138 patients. The results, which showed that uncorrected distance vision was better following surgery than corrected distance prior to surgery, were recently reported in the Journal of Cataract & Refractive Surgery. After two years, 94% of patients were spectacle-independent (as opposed to 0% prior to surgery) and patients expressed satisfaction with the overall improvement in their vision, including driving and vision-related quality of life. ■ New NTIOL applications. CMS is requesting public comment with respect to several new applications for NTIOL status submitted by IOL manufacturers. ASCs receive $50 additional reimbursement for NTIOL lenses but no NTIOLs are currently approved. Alcon has submitted a request to CMS to have four models of its Acrysof Natural IOL designated as an NTIOL under a new class of such lenses for blue-light filtering to improve driving safety under glare conditions. Bausch + Lomb has requested NTIOL status for its Xact IOLs, claiming that their “glistening-free” capacities address problems with decreased contrast sensitivity, increased glare, decreased visual activity and impaired fundus visualization. Hoya Surgical Optics is seeking NTIOL status for its iSert IOL System, claiming reduced complications and accelerated recovery. Lenstec has submitted an NTIOL application for its Softec HD PS lens, claiming reduction of postop residual refractive error. ■ Biggest glaucoma surgical trial funded. Transcend Medical, Inc., an ophthalmic device company developing minimally invasive glaucoma therapies, announced it has obtained additional venture capital financing of $51 million. Transcend will use the funds to develop additional infrastructure and resources for its US pivotal study of the CyPass Micro-Stent, as well as for ongoing international clinical trials and development of next-generation glaucoma solutions. The CyPass is a tiny implant placed in the eye through a minimally invasive surgical procedure, intended to be an earlier intervention than conventional surgical treatments. Transcend says the CyPass may reduce or eliminate the need for glaucoma medications while providing continuous IOP control. ■ Hoya recalls unapproved IOLs. HOYA Surgical Optics (HSO) is voluntarily suspending sales of two models of clear-optic intraocular lenses and requesting that customers return them to HSO. This action affects only US customers, and is limited to the iSymm (Model FC60AD) and iSert (Model PC60AD). HSO indicated that it has been working with the FDA to resolve an issue regarding the approval status of the clear-optic lenses. HSO believes that the regulatory process will be more efficient if the lenses are returned to the company while it continues to work with the FDA to obtain approval. OM |
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