At Press Time
ASC Reform Bill Launched in Congress
Long-awaited changes could soon be law.
By René Luthe, Senior Associate Editor
■ New legislation introduced in both houses of Congress promises to increase Medicare payments to ambulatory surgery centers as well as reduce burdensome regulations on those facilities, according to the Outpatient Ophthalmic Surgery Society (OOSS), which helped develop the bill.
The Ambulatory Surgical Center Quality and Access Act of 2011 aims to accomplish several longtime goals for ASCs, one of them being that Medicare would provide those facilities with the same annual inflation adjustments extended to hospital outpatient departments. Currently, hospital payments are updated by the hospital market basket and ASCs by the consumer price index for all urban consumers (CPI-U).
Explains Michael Romansky, JD, OOSS's Washington counsel, “The dichotomy in update factors is irrational. The CPI-U measures the average change in prices of goods like food, transportation and housing. The hospital market basket reflects the increase in costs for items and services associated with delivering care in a hospital, like nursing services, health technology, etc., which should be identical to the costs incurred by ASCs that treat the same patients for the same conditions.”
The hospital market basket rate has typically been a point higher than the CPI-U, he notes. As a result, the disparity between hospital out-patient rates of reimbursement and those of ASCs had increased each year. “ASC rates are now about 56% of hospital rates,” says Mr. Romansky, “and the difference is totally unrelated to the cost of delivering care to patients.”
The measure also would require CMS to implement a voluntary quality reporting system by 2013. CMS is already authorized to impose mandatory quality reporting, but the bill includes safeguards and standards for ASCs in the event a mandatory reporting system is implemented prior to 2013, as is expected. Additionally, it requires CMS to establish a value-based purchasing program that would create financial incentives for ASCs and the government to partner in moving clinically appropriate services from hospitals to the lower-cost ASC settings, a move that would generate savings to the Medicare system.
According to Mr. Romansky, the most appealing reform in the bill is its repeal of a current CMS policy that prohibits an ASC from performing surgery on a patient the same day the surgeon had diagnosed the need for the procedure. The policy has resulted in significant inconvenience for patients and their families, often forcing them to return to a facility a second time for a YAG procedure and/or having to arrange transportation for another visit.
And while legislation can take a dismayingly long time to make its way through Congress, Mr. Romansky points out that all of the reforms in the bill can be implemented by regulation. “Regardless of whether the bill gets enacted this year or next, or never, we hope to demonstrate to CMS that there is Congressional support for the components of the legislation and that the agency should proceed with the recommended changes on its own existing authority.”
For more information, go to ooss.org or ascassociation.org.
Preventing CME After YAG Capsulotomy
One study favors the use of NSAIDs.
■ What is the best postoperative therapy to reduce the incidence of cystoid macular edema following YAG capsulotomy? In an interesting study presented at ARVO, Adam G. Chun, MD, of the department of ophthalmology at the University of South Carolina School of Medicine, sought to determine if topical steroids, NSAIDs or a combination of the two was the most effective in preventing CME.
Dr. Chun conducted a retrospective study was on 66 eyes of 57 patients who underwent YAG capsulotomy at one surgical center over a period of one year. All cases were performed by one of three resident surgeons.
Following the YAG procedure, all patients were started on one of three treatment regimens: topical steroids, NSAIDs (diclofenac or ketorolac) or a combination of steroids and NSAIDs. All medications were prescribed QID for five days postoperatively. Patients were then re-examined at four weeks and three months postop. Each exam consisted of measuring of BCVA followed by dilated fundus exam. During each dilated exam there was monitoring for development of cystoid macular edema.
Thirty-one patients in cohort 1 received only topical steroids in the immediate postop period. Cohort 2 (21 patients) received only NSAIDs and cohort 3 (14 patients). During the postop period, cohort 1 had three cases of CME, accounting for 9.6% of patients within this cohort. Cohort 2 had no reported cases of CME. Cohort 3 had two cases of CME, which accounted for 14.3% of patients within the cohort.
Cohorts 1, 2 and 3 had a preoperative mean logMAR BCVA of 0.47, 0.44 and 0.64 respectively and postoperative mean logMAR BCVA of 0.28, 0.20 and 0.43 respectively.
Dr. Chun concluded that “there is currently no defined standard of care in the immediate postoperative period after Nd:YAG capsulotomy. Topical steroids and NSAIDs are commonly prescribed in the attempt to prevent cystoid macular edema and postoperative inflammation. All cases of CME were seen in patients who had received topical steroids, while no patients on monotherapy with NSAIDs developed CME.”
Dr. Chun noted that NSAIDs directly block the cyclooxygenase enzyme and ultimately decrease prostaglandin synthesis, which is thought to be the cause of CME. Those in the NSAID only group also had a small but significant improvement in BCVA over the other two cohorts. Based on this study, Dr. Chun concluded that NSAIDs may be the preferred postop treatment regimen following YAG capsulotomy in the prevention of CME and improved BCVA.
Same-Day Bilateral Cataract Surgery
Comparative study finds dual procedure safe, less costly.
■ Researchers from the Helsinki University Central Hospital in Finland conducted a large-scale study to compare outcomes between same-day bilateral cataract surgery and sequential cataract surgery done four to six weeks apart. The study results, which encompassed a total of 490 patients, were recently reported in the Journal of Cataract & Refractive Surgery. (Ophthalmology Management reported on the potential of same-day bilateral cataract surgery in our August 2010 cover article.)
The main clinical outcomes measured in the Finnish study were corrected distance visual acuity, refraction, complications, Visual Function Index scores and patient-rated satisfaction with vision.
With 240 patients in the study group and 250 patients in the control group, the refraction was within 0.50 D of the target in 67.2% of the eyes in the study group and 69.2 of the eyes in the control group. The refraction was within 1 D of the target in 91% of the eyes in the study group and 90.3% of the eyes in the control group. The only complication that affected postop visual acuity was chronic CME in one eye in the study group and two eyes in the control group. Ninety-five percent of the patients in both groups reported being very satisfied with their surgery.
The same group of researchers also conducted an economic analysis of this simultaneous vs. sequential cataract surgery study. They tabulated both healthcare-related costs (staff, equipment, supplies, overhead, all patient encounters) and non-healthcare costs (patient travel, lost time from work, home care). When all costs were accounted for, the same-day bilateral procedure provided an overall savings of 649 euro (about $920 US) compared to sequential surgery.
The researchers concluded that same-day bilateral surgery provided comparable clinical outcomes with substantial savings in healthcare and non-healthcare costs.
Malpractice Payments: Going Up or Down?
A watchdog group sees declining payouts—but is disputed.
■ A study released recently by the self-styled people's advocate Public Citizen indicates that reported malpractice payments—encompassing jury awards and settlements—declined for the seventh consecutive year in 2010, based on its analysis of newly released figures from the National Practitioner Data Bank (NPDB). According to NPDB figures, the number of 2010 payments totaled 10,195, which also is the lowest since 1991, the first full year for which NPDB tracked these payments.
The NPDB numbers were immediately disputed by the AMA and the Physician Insurers Association of America (PIAA). These organizations contend that NPDB data are unreliable and “inherently flawed” because of a long record of unreported malpractice payments and disciplinary actions.
As reported by Medscape Medical News, critics of the Public Citizen report cite a 2000 study by the former US General Accounting Office, now the US Government Accountability Office, stating that “NPDB information may not be as accurate, complete, or timely as it should be.”
According to the Government Accountability Office, some payments triggered by medical malpractice do not get reported because of a “corporate shield” loophole. That happens when someone sues both a hospital and a physician and then drops the physician from the claim as part of a settlement, making the hospital the only responsible party. Malpractice payments made on behalf of hospitals do not have to be reported to the NPDB.
This pattern of physicians disappearing from lawsuits has persisted into 2011 and may be intensifying because more and more physicians are becoming hospital employees, Lawrence Smarr, president and chief executive officer of the PIAA, told Medscape. “We know that the number of claims reported will drop simply because of that factor,” said Mr. Smarr, who represents the PIAA on the NPDB's executive committee. In some cases, he said, plaintiffs' attorneys refrain from naming a physician as a defendant when the codefendant is the hospital that employs him or her.
“It's no secret,” Mr. Smarr told Medscape. “There is a massive amount of underreporting of payments to the databank.”
Public Citizen cited NPDB figures showing that the total dollar value of payments declined for the seventh straight year, decreasing to $3.35 billion in 2010. It said the average malpractice payment rose 1.6% in 2010 to $328,303, representing the lowest average payment in eight years.
The Public Citizen analysis asserts that malpractice litigation is not the cost-driver in healthcare that some political conservatives depict it to be. Between 2000 and 2010, malpractice payments fell 11.9%, whereas healthcare spending rose 90%, according to the study. Such payments amounted to only 0.13% of healthcare costs in 2010, the lowest percentage in the NPDB's history.
These numbers, if accurate, dispute the contention that medical malpractice suits are largely frivolous, according to Public Citizen. Of the 10,195 payments in 2010, almost 75% were for either death or some sort of significant or major injury, including quadriplegia, as opposed to insignificant or minor injuries or emotional injuries only.
In the News … |
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■ Meaningful use checks begin to flow. CMS has reported that the first batch of bonus checks went out in late May to medical practices qualifying for the “meaningful use” of electronic health records. The Eye Center of Central Pennsylvania, a client of Medflow, was among the first ophthalmology practices to receive a check. ■ FDA panel unanimous in recommending VEGF Trap-Eye. The FDA advisory committee that reviews ophthalmic drugs voted 10 to 0 at a meeting on June 17 to recommend VEGF Trap-Eye for FDA approval for the treatment of wet AMD. The panel also recommended that dosing for the Regeneron/Bayer drug by intravitreal injection could be every eight weeks, with monitoring at the discretion of the physician. The major potential FDA-approved competitor for VEGF Trap-Eye, Genentech's Lucentis, is indicated for monthly intravitreal injections for wet AMD, a difference in dosing that could be significant in reducing the treatment burden for retina specialists and patients. VEGF Trap-Eye will be marketed under the brand name of Eylea. It is expected that the FDA will make a decision on final approval for Eylea by August 20. ■ MEEI/Schepens have combined. The Massachusetts Eye and Ear Infirmary (MEEI) and Schepens Eye Research Institute have combined to create the world's largest basic and clinical ophthalmology research enterprise with full spectrum bench-to-bedside research expected to translate more quickly into better treatment for blinding diseases and ultimately cures. Schepens, the largest independent ophthalmology research institute in the United States, on June 30 became a part of MEEI, under the direction of the MEEI board of directors. MEEI is an academic medical center providing clinical care, conducting eye research and educating eye specialists. Schepens will remain a nonprofit and retain its name. Both institutions have long traditions of clinical and research excellence. Their areas of expertise and technology are considered to be complementary—basic research at Schepens and clinical research at MEEI are expected to be enriched by each other's respective strengths. ■ New Marfan syndrome diagnostic tool. The National Marfan Foundation has launched a mobile Web site, www.MarfanDX.org, with content based on newly published criteria for the syndrome. The site contains photographs, formulas and two key score calculators to aid in diagnosing and managing both Marfan syndrome and related disorders. Ophthalmologists can play a larger role in the diagnosis than ever thanks to the new criteria, developed by a team led by Bart Loeys, MD, at the Center for Medical Genetics at Ghent University in Belgium. Ectopia lentis is now noted as one of the cardinal features and is weighted more heavily than almost all other symptoms. While half of the estimated 200,000 people with Marfan syndrome are undiagnosed, the condition's eye problems can often bring patients into the doctor. The new site is compatible with Droid and iPhone smartphones and is also viewable on a desktop computer. ■ Sustained-release implant for latanoprost. Drug-delivery company pSivida Corp has begun a phase 1/2 clinical trial studying a new bioerodable drug-delivery insert for the treatment of glaucoma and ocular hypertension. The insert is designed to provide long-term, sustained release of latanoprost, the most commonly prescribed agent for reduction of IOP in patients with ocular hypertension and glaucoma worldwide. The insert, which is being developed under a research and collaboration agreement with Pfizer, is designed to be placed in the eye via a minimally invasive, outpatient procedure; it is also designed to be injected into the subconjunctival space of the eye. ■ Lack of compliance for equipment disinfection/hand hygiene. Members of the New England Ophthalmological Society were anonymously surveyed on their disinfection practices for exposed equipment and hand hygiene. The responses were recently presented at ARVO. Seventy-seven percent of polled members clean the applanation tip with alcohol when checking IOP in patients without suspected viral conjunctivitis. A little over half of respondents (53%) reported full compliance with hand cleaning between each patient, while 84.6% said they cleaned hands between patients at least half of the time. No preference for hand sanitizers versus soap and water was reported. Full compliance based on the AAO guidelines for disinfecting exposed equipment was reported, but there was not full compliance based on the CDC guidelines for equipment disinfection or hand washing. The researchers recommend following the CDC guidelines for soaking applanation tips for five to 10 minutes in 1:10 diluted bleach, as well as washing hands between each patient. ■ Unique phase 3 blepharitis trial. InSite Vision said the company has reached an agreement with the FDA on a Special Protocol Assessment for the design of a unique phase 3 clinical trial of both AzaSite Plus and DexaSite in patients with blepharitis. The DOUBle (Dual Ophthalmic agents Used in Blepharitis) study will seek to enroll 900 patients with moderate-to-severe blepharitis in a four-arm trial designed to evaluate both product candidates simultaneously. InSite Vision is concurrently developing two phase 3 product candidates formulated with the company's proprietary DuraSite drug-delivery platform for the treatment of blepharitis. AzaSite Plus combines dexamethasone 0.1% with the antibiotic AzaSite (azithromycin 1% ophthalmic solution) in DuraSite for the treatment of acute and chronic blepharitis. DexaSite, which combines dexamethasone 0.1% with DuraSite, is intended to rapidly reduce inflammation in non-bacterial blepharitis. ■ OIS to be acquired. Merge Healthcare, a provider of healthcare enterprise imaging and interoperability solutions, and Ophthalmic Imaging Systems (OIS), a provider of digital imaging and informatics solutions for ophthalmology and other medical specialties, have announced the signing of a definitive merger agreement pursuant to which Merge Healthcare will acquire OIS. “With OIS we will add the important specialty of ophthalmology,” said Jeff Surges, CEO of Merge Healthcare. “Demand for ophthalmic imaging solutions is increasing due to factors such as an aging population, improved treatment results based on early disease recognition and increased incidence of visual impairment, as well as the growing need for portable diagnostic equipment. OIS is a recognized leader in ophthalmic imaging and informatics. The OIS solution suite and client base of prominent clinics and hospital networks are an ideal complement to our enterprise imaging capabilities and will be a great addition to our solutions portfolio.” OM |