At Press Time
HHS Extends EMR Implementation Timetable
One-year delay for meeting stage 2 requirements.
By Jerry Helzner, Senior Editor
■ Department of Health and Human Services Secretary Kathleen Sebelius has announced a one-year extension for meeting the Stage 2 “meaningful use” requirements for electronic medical records implementation for practices that have already adopted EMR. The target date for Stage 2, which had previously been Jan. 1, 2013, has now been moved back to the same date in 2014.
“My take on the change is that the government recognizes the challenges that practices have had trying to comply with meaningful use,” commented Peter Polack, MD, writer of the Path to Paperless column for Ophthalmology Management. “They set up the timetable with 2011 beginning for Stage 1 and then 2013 for Stage 2, but apparently some large early-adopter entities (clinics, regional healthcare delivery groups) say that it will be difficult to be ready for Stage 2, in part because the EMR companies don't have all of the functionalities ready for that.”
Dr. Polack added that in recognizing that the original timetable might not be possible to meet, 2011 was made a “grace” year, so that practices that wait until 2012 will not be penalized.
“Now, they are telling practices that are early adopters that they will get a bonus year. I think it is a realization that the technology may not have quite caught up with the specific criteria,” Dr. Polack said.
“When doctors and hospitals use health IT, patients get better care and we save money,” said HHS Secretary Sebelius.” We're making great progress, but we can't wait to do more. Too many doctors and hospitals are still using the same record-keeping technology as Hippocrates. Today, we are making it easier for healthcare providers to use new technology to improve the healthcare system for all of us and create more jobs.”
In a related development, a recently released survey undertaken by the CDC indicates that the percentage of office-based physicians using electronic records increased from 17% to 34% between 2008 and 2011 and that 52% of office-based physicians now believe that they can qualify for federal bonus payments before they expire.
“We are pleased that recent data shows there is a high interest among physicians to take advantage of the available incentive payments through the government's EHR Incentive Program,” said Steven Stack, MD, chair-elect of the American Medical Association. “But we remain concerned that this increase in EHR adoption will not occur unless the program maintains sufficient flexibility in later stages. We look forward to reviewing the proposed rule as soon as it is published to ensure that the Stage 2 measures are both meaningful and achievable for physicians.”
Safe Surgery Checklist Required for ASCs
Medicare quality reporting program brings new mandates.
By Samantha Stahl, Assistant Editor
■ Ambulatory surgery centers are now mandated to use a safe surgery checklist. They must have been in compliance no later than January 1 of the new year, according to the Ambulatory Surgery Center Association (ASCA).
Beginning in 2013, all Medicare-certified ASCs will annually be required to report whether or not they used a checklist throughout the entire year as a part of Medicare's quality reporting program. Any ASC that fails to meet the 2012 and subsequent Medicare quality reporting requirements will face future payment reductions.
While ASCs will not have financial penalties for the first year if the center reports it did not use a checklist in 2012, CMS plans on making the reports public, said ASCA executive director, William Prentice, in the December issue of Outpatient Surgery magazine. “Being able to report wide-scale use of safe surgery checklists will further strengthen our record of quality care,” he said.
At the Blue Ridge Surgical Center in Kansas City, Mo., the surgical safety checklist is broken down into four components, said Steven Silverstein, MD, FACS, who specializes in cataract surgery and cornea transplantation.
■ Admit to Holding: The patient (or patient representative) confirms with a nurse his or her identity, date of birth, a responsible adult driver for after the procedure, consent, surgical site, NPO status, any oral meds, preop antibiotics when necessary, H&P on the patient chart and any known allergies
■ Anesthesia: The RN and anesthesia-care provider confirms the patient's identity, surgical site, procedure, known allergies and completes an anesthesia safety check
■ Time-Out: Prior to incision, the surgical team confirms the patient's identity, marked surgical site, lens type and power and follow-up appointment. The scrub and circulator confirm the sterilization indicators
■ Sign-Out: Before the patient leaves the operating room, the name of the operative procedure is noted. When appropriate, the completion of sharps and the count is taken down, and specimens are identified and labeled
Following a checklist such as this one will ensure compliance with CMS's requirements.
Dr. Stulting: Academia Inhibits Research
He sees clinical research moving to private practices.
■ R. Doyle Stulting, MD, PhD, who had a long career as a highly respected practitioner and researcher at Emory University, is warning of a trend in academia that is making it “extremely difficult for physicians to collaborate with industry as consultants or investigators.” Dr. Stulting made his views known in a recent article in Cataract & Refractive Surgery Today titled “Why I Left Academics.”
Dr. Stulting, who is now director of the Stulting Research Center at the Woolfson Eye Institute in Atlanta, recounts a steady shift in Emory policies from a physician-friendly environment to one where new rules and regulations “hampered doctors' ability to carry out clinical research, both for sponsored clinical trials and for physician-sponsored studies.”
At one point, he says Emory policymakers prohibited faculty from accepting medications and pharmaceutical samples from industry, “even when purportedly for use by the individual and colleagues for patient care or education.” Dr. Stulting writes that the use of the word “purportedly” implied “a presumption of dishonesty on the part of the faculty.” At this point, Dr. Stulting wondered whether he could continue to work at Emory
Noting that Emory is not alone in academia in instituting changes that inhibit research, he says the result will be a shift of clinical research to private practices and also overseas. He says the effect will be “reduced exposure of medical trainees to advanced technologies and the minds that create them, the loss of jobs from the United States to other countries, the exportation of intellectual assets from academic institutions and the United States, and eventually, the loss of a leadership role for the United States in medical innovation.”
Dr. Stulting says since returning to private practice he has been able to negotiate contracts for clinical research without interference, making the practice “an attractive site” for clinical trials.”
The Emory University Department of Ophthalmology declined to comment on Dr. Stulting's assertions.
Research Digest
New & Noteworthy Journal Articles
Compiled by Andrew E. Mathis, PhD, Medical Editor
► Following the money. To what extent do fees affect the choice of glaucoma procedure? Ophthalmologists in Toronto collaborated on a study to determine the answer to this question. They report their findings in the December 2011 issue of the Journal of Glaucoma.
In this retrospective, population-based study, the authors consulted several databases to obtain yearly population by Canadian province, numbers of procedures performed and fees for trabeculoplasties, trabeculectomies and glaucoma drainage device (GDD) implantations between 1992 and 2007. The authors conducted regression analysis to determine what influence, if any, fees had on the choice of treatment.
While trends in glaucoma procedures and fees varied widely across Canada, with all three procedures demonstrating either increases or decreases in popularity depending on province, and while the fees varied widely for the three treatments, the authors did not detect a statistically significant effect of fees on treatment choices. For every 1,000 patients with glaucoma, a C$100 increase in fee was correlated with (in increasing order of cost) 0.68 more trabeculoplasties, 1.2 fewer trabeculectomies and 0.18 more GDD implantations, and for every additional ophthalmologist per 1,000 patients, trabeculoplasties increased by the highest rate (53.8 more, vs. less than one each for trabeculectomy and GDD implantation).
The study authors note the role of national health insurance availability in Canada in this study: because there are no out-of-pocket costs for patients, patient cost is not a factor in treatment choice. As such, the data from this study can be only minimally compared with US data.
► Macula trauma outcomes. Blunt-force trauma can cause long-term damage to the retina, but because of the tendency for these injuries to be presented in emergency departments, long-range data are scarce. In a small retrospective case series appearing in the November 2011 issue of Retina, a team of French ophthalmologists followed up 20 patients for six months to determine the long-term outcomes in acute traumatic maculopathy.
All 20 cases reviewed for this article were diagnosed with acute traumatic maculopathy at presentation, based on macular opacification following blunt trauma. All of the patients were subjected to optical coherence tomography (either time domain or spectral domain) at the one-week visit to measure central macular thickness and to electroretinography (ERG) at the six-month visit.
In this young (mean age 20.8 years old) cohort, the mean visual acuity at presentation was 20/100. The initial OCT examinations showed increased reflectivity of the inner and outer segment junction with apposition of the outer segment to the retinal pigment epithelium. Initial ERG showed decreased amplitude in the central area but not in the periphery. These changes persisted at six months, while the one-week OCT results had returned to normal.
The authors conclude that although the long-term VA results in acute traumatic maculopathy are excellent, it seems that long-term damage may be done to the inner and outer segments, with consequent reduction in electroretinal activity at six months. They suggest further research on the long-term effects on retinal structures of blunt-force trauma.
► New dry eye agent. The leadoff article in the January 2012 issue of Cornea provides the results from a recent trial of artificial tears in dry eye disease. Scientists in Italy and the United Kingdom compared sodium hyaluronate, hydroxypropyl methylcellulose (HPMC) and Emustil unidose, a new oil-in-water emulsion, in terms of efficacy.
Seventy-five subjects with DED were randomized into three groups and were allocated one of the three agents. The subjects used their assigned artificial tears four times per day for 90 days, and parameters were measured at baseline, 30 days and 90 days, with compliance visits scheduled at seven and 60 days.
While all three artificial tears resulted in statistically significant reductions in evaporation and improvements in symptoms and while all three agents also resulted in no significant increases in the tear turnover rate, the sodium hyaluronate and Emustil groups experienced better stability and noninvasive tear breakup times, which were not seen with HPMC. Further, the Emustil group saw significant decreases in osmolarity and corneal staining that were not observed in either of the two other groups.
The study authors believe that the Emustil group's superior outcomes were a direct result of improvement in the lipid layer of the tear film because of the use of an oil emulsion. Given the prospective nature of the study, the authors see their results as complementing an already growing body of evidence supporting the use of oil emulsions in dry eye treatment regimens.
► New DSEK data. Archives of Ophthalmology has published online the results of an observational case series evaluating visual acuity and straylight in patients with Fuchs dystrophy following Descemet's-stripping endothelial keratoplasty (DSEK). In this collaboration between doctors at the Mayo Clinic in Rochester, Minn., and the Netherlands, 147 eyes with Fuchs dystrophy that were submitted to DSEK were examined for VA, straylight and corneal thickness. DSEK resulted in significant increases in postoperative VA and reduction in straylight, while outcomes in terms to corneal thickness were not significant. Given the marked reduction in straylight seen in this study, the authors suggest that preoperative straylight may be a good indicator of postoperative outcomes. OM
In the News … | ■ OptiMedica laser cataract system gets FDA approval. OptiMedica Corp. has announced FDA 510(k) market clearance of its Catalys Precision Laser System, a next-generation laser cataract surgery system that brings what OptiMedica terms “precision and accuracy and a markedly streamlined workflow to the laser cataract procedure.” Catalys combines a femtosecond laser, OCT imaging and pattern-scanning technology for performance of imageguided preoperative laser lens conditioning. The system is now FDA cleared for capsulotomy and/or lens fragmentation. Study results published in the Journal of Cataract & Refractive Surgery indicate that Catalys produces capsulotomies within 30 µm of intended size and 80 µm of intended center, with near-perfect circularity. Laser lens fragmentation with Catalys has also been shown to improve the ease of lens disassembly, reducing cumulative dissipated energy during ultrasound phacoemulsification by approximately 40%. ■ Osmolarity test gets CPT code. The TearLab osmolarity test for dry eye diagnosis will receive its own CPT code effective this month, the manufacturer said. The payment code of 83861 that currently applies to the test will be cross-walked or paired with code 84081. At current 2011 reimbursement rates, payment code 83861 would be reimbursed in every state by CMS at $23.25 per eye. ■ New book recounts Aravind Eye Hospital saga. In its 35 years of existence, the Aravind Eye Care Hospital in India has become world famous and treated more than 32 million patients, from the former president of India to millions of charity cases. The growth of Aravind is due to the efforts of a visionary ophthalmologist, Dr. Govindappa Venkataswamy, known as Dr. V. The many American ophthalmologists who have participated in the growth of Aravind will be happy to know that the saga of this unique facility is now being told in a book entitled Infinite Vision, written by Dr. V's grandniece, Pavithra Mehta, and Suchitra Shenoy, who has also been associated with Aravind for many years. The authors tell the story of Dr. V's Herculean efforts to deliver superior eye care on a massive scale, especially to the huge number of India's aged poor who are able to continue productive lives thanks to Aravind's groundbreaking innovations in cataract surgery. ■ Rayner aspheric IOL approved. Rayner Intraocular Lenses Limited said the FDA has approved its C-flex Aspheric 970C for sale in the United States. The C-flex offers features such as the company's anti-vaulting haptic technology, Rayacryl hydrophilic acrylic material and the Amon-Apple enhanced square edge for reduced PCO rates. The C-flex 970C will be available in the power range: +18.0 D to + 30.0 D in 0.5 D increments. ■ Valeant bids to take over Ista. Valeant Pharmaceuticals has made a hostile bid for Ista Pharmaceuticals after Ista, best known for its NSAID Bromday and glaucoma medication Istalol, refused Valeant's repeated merger overtures. Valeant offered $6.50 for each of Ista's 41.5 million shares, which constitutes a significant premium over Ista's stock price of $3.90 prior to the offer being made public. Ista called the offer “grossly inadequate” and said it would explore its options. Valeant is a specialty pharmaceutical company that develops and markets both its own drugs and branded generics. ■ Dual trial for blepharitis drugs. InSite Vision said patient enrollment has begun in the DOUBle phase 3 clinical trial of AzaSite Plus and DexaSite for the treatment of blepharitis. The DOUBle study will seek to enroll approximately 900 patients suffering from moderate-to-severe blepharitis in a four-arm trial designed to evaluate the efficacy and safety of both product candidates simultaneously. “We have worked closely with the FDA to establish clinically meaningful endpoints for this unique study, which will evaluate two investigational drugs simultaneously,” said Kamran Hosseini, MD, PhD, vice president and chief medical officer of InSite Vision. “As part of that effort, we have created two proprietary tools — an investigator scoring system and a patient quality-of-life survey — designed to measure disease severity and aid in monitoring treatment response, which will set the standard for managing treatment outcomes.” ■ Victus combination platform earns CE mark. Bausch + Lomb and Technolas Perfect Vision GmbH have received the CE Mark approval and commercial availability of the multi-functional Victus Femtosecond Laser Platform in the EU. The Victus is approved in the EU for LASIK flap, astigmatic keratotomy, Intracor, capsulotomy and lens fragmentation. The Victus is designed to support cataract, refractive and therapeutic procedures on a single platform. B+L says the femtosecond laser technology enables greater precision in both cataract and refractive procedures compared to manual techniques, giving ophthalmologists more control and potentially enhancing the patient experience. |
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