Bimatoprost study gives doctors hope
Treatment device is one step closer to market.
By Bill Kekevian, Senior Associate Editor
Now that Allergan (Irvine, Calif.) has data from phase 2 clinical trials suggesting the efficacy of its bimatoprost sustained-release implant is comparable to the solution’s daily topical application for treatment of elevated IOP and glaucoma, ophthalmologists are expressing cautious optimism about the new delivery method.
“A sustained release implant with the efficacy of a prostaglandin analog will offer drops-free therapy for many glaucoma patients,” says Nathan Radcliffe, MD, director of glaucoma service & clinical assistant professor at NYU.
The next step for Allergan is to start phase 3 trials which, the company says, will begin this year.
“The obvious advantage of this implant is the elimination of noncompliance associated with drop administration,” says Frank Cotter, MD, of the Vistar Eye Center in Roanoke, Va. “The obvious disadvantage is the need for an intraocular injection. Given the current widespread use of anti-VEGF injections, there may be greater acceptance of this method of delivery than may have existed a decade ago.”
Angelo Tanna, MD, director of glaucoma services at Northwestern University’s Feinberg School of Medicine, says the new innovation provides a potential benefit of reduced local side effects.
“Most of the side effects of the ocular hypotensive prostaglandin analogs observed in clinical practice are local adverse effects such as conjunctival hyperemia and cosmetic eyelid abnormalities such as hyper pigmentation,” Dr. Tanna explains. “The fact that these side effects are attributable to the relatively high concentrations of the drug applied to the ocular surface, the new delivery approach will likely be associated with a marked reduction in these adverse events.”
By the Numbers: Glaucoma
Glaucoma-related US vision loss
Source: Glaucoma Research Foundation: Glaucoma Facts and Stats: http://www.glaucoma.org/glaucoma/glaucoma-facts-and-stats.php
However, he cautions, “what we do not yet know is whether there will be an increased risk of intraocular inflammation or macular edema.”
“The benefit versus risk will need to be assessed for each patient. However, an option may soon be available for patients who are unable to comply with drop therapy,” adds Dr. Cotter.
Beta-blocker drops for acute migraines?
Relief may require only a $4 generic.
By René Luthe, Senior Editor
Acute migraine headaches may be stopped or often reduced in intensity with beta blocker eye drops, the widely available glaucoma medication that costs as little as $4 per bottle, according to John C. Hagan III, MD and Carl V. Migliazzo, MD, both of Kansas City, Mo. The pair have published a study of seven acute migraines patients treated over a multi-year period.1 While the daily use of beta blocker pills has proved effective in preventing chronic migraine headaches, they have been unsuccessful in treating acute, sudden-onset migraines. Beta-blocker eye drops, however, are absorbed more quickly than pills by tear duct drainage onto the nasal mucosa, the investigators say, achieving therapeutic plasma levels “within minutes.”
Drs. Hagan and Migliazzo note that their study is small, selective and retrospective — all seven of the case studies involved female patients, for instance — and as their peer reviewers pointed out, controlled prospective studies are needed. The University of Kansas Medical Center, Kansas City, plans to launch its own prospective study and has invited Drs. Hagan and Migliazzo to be part of the protocol development.
While the findings are exciting, Dr. Hagan notes that developing a commercial product may be problematic. “Big pharma has some interest in trying to develop a commercial product,” he says. “But obviously, there is no way a company could justify the investment required to get an FDA-approved indication for an eye drop that’s available for $4. There would have to be some sort of unique delivery system that would be patentable.” Dr. Hagan points out physicians who want to try the treatment using generic beta blocker eye drops should read the study and inform the patient of its’ off-label use. “They could do that today.”
1. Migliazzo CV, Hagan JC. Beta-blocker eyedrops for treatment of acute migraine. Missouri Medicine. 2014; 111:283-288.
Researchers have demonstrated advanced DNA testing for congenital cataracts can diagnose a number of rare diseases marked by childhood blindness, according to an Ophthalmology study available at: http://tinyurl.com/pnwnteo.
Depression in AMD patients with low vision can be halved with integrated therapies. In a recent study in Ophthalmology, researchers combined low-vision rehabilitation and psychological therapy and followed 188 AMD patients with early signs of depression, which affects up to 30% of those with AMD. After four months, the researchers found that the incidence of depressive disorders was 12.6% in the group randomized to eight weeks of in-home behavior activation therapy in addition to low-vision rehabilitation versus 23.7% for the group given supportive therapy and low-vision therapy. The incidence of depression in the supportive therapy group was similar to that reported in the absence of any treatment, according to the investigators.
Alcon announced an agreement to acquire WaveTec Vision, developer of the intraoperative guidance ORA System. Alcon says the ORA System will complement its Verion preoperative diagnostic system.
Beaver-Visitec, a manufacturer and marketer of microsurgical products, has announced its acquired Endo Optiks, a company that developed an endoscopy system. Endoscopic procedures are performed for glaucoma and retinal issues.
AAO, ABO live in MOC harmony
While other disciplines object, ophthalmology academy accepts board certification process.
By Bill Kekevian, Senior Associate Editor
The maintenance of certification process has come under fire from specialty societies, who have argued to the American Board of Internal Medicine that the process is cumbersome and misrepresents lifetime certificate holders to the public. But in the world of ophthalmology the representative specialty society (the AAO) and the certifying board (the American Board of Ophthalmology) are in harmony when it comes to this process.
“Given the complexity of this process, The American Board of Ophthalmology (ABO) has done a much better job than some of these other boards at rolling out ophthalmology MOC,” says David W. Parke II, MD, CEO of the AAO.
John G. Clarkson, MD, ABO executive director, chalks the close relationship up to communication between the groups. “We try to keep the lines of communication open at all times by requesting feedback from our diplomats on the MOC process and on our examinations. We also have learning sessions at the AAO Annual meeting to discuss MOC and answer questions,” Dr. Clarkson says.
Representative societies in internal medicine are insisting, among other things, the MOC process become less cumbersome. Ophthalmology is already realizing this vision by preparing its recently-launched “Intelligent Research in Sight (IRIS)” clinical data registry as a way to submit data to the ABO such that it takes little effort, time and cost,” says Dr. Parke.
Some doctors remain unimpressed. “[Recertification] only adds cost to private practice, distracts physicians from patient care, creates a $2B industry that pays a few doctors managing MOC high salaries for promoting the process. It does nothing to improve patient care (despite a medical and federal culture demanding accountability and outcomes analysis), and ultimately will be used to restrain competition by selecting against certain doctors and effecting state licensure,” says Jeffery Liegner, MD of Eye Care Northwest in Sparta, New Jersey.
Dr. Clarkson understands the frustration some doctors experience in the certification process. “In general, doctors are at a point where they feel overwhelmed by what they see as outside interference in medicine, such as demands from regulatory groups; EHR concerns; changes to Medicare reporting and reimbursement rules; mandates from insurers; new state re-licensure requirements; and complex hospital privileging processes,” he says.
Recent MOC updates
In listening to diplomate feedback, The ABO continues to adapt the MOC program accordingly. Here are a few recent examples:
• To add flexibility to the process of completing Practice Improvement Modules (PIMs), we’re currently pilot testing a program that allows for individualized quality improvement projects for MOC credit.
• To make the MOC process more relevant to actual practice, we provide ways to customize each exam and activity to the diplomate’s area of practice focus (ie, glaucoma, retina, pathology, etc.).
• To provide more ways for diplomates to earn MOC credit for quality improvement work they’re already doing, the ABO joined the MOC Multi-Specialty Portfolio Program which recognizes institution-based projects.
• To eliminate the burden of lump sum exam registration fees, new and newly recertified diplomates pay $200 per year as an annual fee, which covers all MOC activities over the 10-year cycle.
But Dr. Parke suggests ophthalmologists understand competence assessment as a logical companion to self-education. “I think every ophthalmologist is committed to the concept of life-long learning as a philosophy and to the continual expansion of clinical capability. None of us went into ophthalmology to be below average, and we recognize that ophthalmic knowledge doubles statistically every three to four years, so you have to stay on top of it,” says Dr. Parke.
Potential Medicare payment policy reform coming?
MedPAC looks to address differences in reimbursements for similar services.
By Zack Tertel, Senior Associate Editor
Mark E. Miller, PhD, executive director of the Medicare Payment Advisory Commission (MedPAC), expressed the need for changes to Medicare’s payment policies across various sites of post-acute care (PAC) before the U.S. House of Representatives Energy and Commerce Subcommittee on Health.
“Federal policymakers are at last beginning to comprehend the perverse consequences emanating from a reimbursement system that overpays hospitals and underpays ASCs for providing the same services,” says Michael Romansky, JD, Ophthalmic Outpatient Surgery Society Washington Counsel and vice president of Corporate Development.
Dr. Miller discussed three primary reform options during his testimony. First, he recommended a standardized assessment tool that would provide comparable information to evaluate patients treated in different PAC settings as well as the differences in cost and outcomes that beneficiaries receive.
Standardized assessment would help establish Dr. Miller’s second recommendation: site-neutral payments across PAC settings. This would help beneficiaries to receive appropriate care in the least costly setting consistent with their conditions, Dr. Miller said.
Finally, Dr. Miller suggested pay for providers based on quality of care and the success of their care coordination. In particular, the move would penalize unnecessarily high readmission rates that raise costs, thus giving incentive to coordinate care across settings and to improve the number of preventable episodes.
“Several of these policies could be implemented in the near-term and would serve as building blocks for broader payment reforms,” Dr. Miller said. “In the future, the Commission envisions Medicare moving toward payment systems that are based solely on the needs of the patient, irrespective of the site of care, and that give providers greater accountability over the quality and cost of the care provided to Medicare beneficiaries.”
Virtually all high volume eye surgeries would meet these parameters, Romansky says.
Reform benefits for ASCs include the narrowing of payment disparity between HOPDs and ASCs, a potentially higher annual update if policymakers adopt the hospital market basket for ASCs, as well as the eventual migration of services from HOPDs, he says.
“Ophthalmologists across the country tell me that many hospitals are already unenthusiastic about ophthalmic surgery. Hospital administrators’ concerns can only be exacerbated if payment rates are substantially reduced,” Romansky says.
Whether and when Congress will adopt these proposals remains to be seen, but Romansky believes they will be seriously considered on Capitol Hill.
“Were Congress to adopt this MedPAC recommendation, the increase in revenues to ASCs from expanded volume of cataract, vitreoretinal, glaucoma and other cases would likely be substantial,” he says.
Efficiency isn’t always equivalent to speed
tip of the month
In the era of EHR implementations, government mandates and increased patient flow, efficient practice management techniques are in the spotlight. However, Pravin U. Dugel, MD, of Retinal Consultants of Arizona, warns that important steps may be lost in the hurry to improve efficiency.
“People often confuse efficiency with speed, but the two are not equal,” he says. “Being efficient means getting the safest results with the minimum amount of wastage. My staff may finish tasks faster to make sure everything in our surgery center is efficient, but I never tell someone to work faster or rush to do something at a speed that makes them feel uncomfortable. Rather, we make sure they waste as little energy and time as possible to accomplish what they need to do.”
To submit your own practice tip e-mail: firstname.lastname@example.org.
Operation Sight fights cataract blindness in US
This summer, Kerry Soloman, MD, at Physician’s Eye Surgery Center in Charleston, South Carolina, performed the first two charitable cataract surgeries as part of the new ASCRS Foundation’s network, Operation Sight. Operation Sight is a network designed to provide cataract surgeries to working poor who fall outside traditional insurance and social safety nets. The foundation’s plans involve seeing 100 charitable cataract surgeries completed next year. For more see: www.operationsight.org.
What you need to know about changes to Meaningful Use
A quick reference to understanding changes to CEHRT requirements.
By Jeff Grant, president & founder, Healthcare Management & Automation Systems, Inc.
The Department of Health & Human Services released the much anticipated final rule last month. The new rule offers significant flexibility of Meaningful Use reporting and attestation in 2014.
The changes were made because Office of the National Coordinator for Heath Information Technology (CMS/ONC) recognized that EHR vendors and practices alike were struggling to implement 2014 Edition CEHRT in time to complete a reporting period in 2014. The previously announced extension of Stage 2 through the end of 2016 was made final in this latest Final Rule. This means that Stage 3 will not start for anyone until 2017.
The new rule doesn’t change the length of the reporting periods in 2014, which, because of a previous change to the rules, allows everyone to use a calendar quarter in 2014 instead of a full calendar year (first year attestors still get to use a 90-day reporting period not tied to a calendar quarter).
However, because of the new rule, you might want to change the reporting period you planned on using in 2014.
OPTIONS AVAILABLE IN 2014
Three options are now available:
• Use 2011 Edition CEHRT for the entire reporting period.
• Use a combination of 2011 Edition CEHRT and 2014 Edition CEHRT for the reporting period.
• Use 2014 Edition CEHRT for the reporting.
• Depending on what stage you were scheduled to meet this year and which option from above applies to you (or which option you choose), you can now determine which of the following you’re allowed to use in 2014:
• Stage 1 2013 Rules (including 2013 CQM’s).
• Stage 1 2014 Rules (including 2014 CQM’s).
• Stage 2 2014 Rules (including 2014 CQM’s).
Figure 1 should help clarify your options.
|If you were scheduled to demonstrate:||You would be able to attest for Meaningful Use:|
|Using 2011 Edition CEHRT to do:||Using 2011 & 2014 Edition CEHRT to do:||Using 2014 Edition CEHRT to do:|
|Stage 1 in 2014||2013 Stage 1 objectives an measures*||2013 Stage 1 objectives and measures*
2014 Stage 1 objectives and measures*
|2014 Stage 1 objectives and measures|
|Stage 2 in 2014||2013 Stage 1 objectives an measures*||2013 Stage 1 objectives and measures*
2014 Stage 1 objectives and measures*
Stage 2 objectives and measures*
|2014 Stage 1 objectives and measures*
Stage 2 objectives and measures
|*Only providers that could not fully implement 2014 Edition CEHRT for the EHR reporting period in 2014 due to delays in 2014 Edition CEHRT availability|
The Final Rule specifically states that if you haven’t been able to implement a 2014 Edition CEHRT, you could go back to an earlier quarter this year (Q1 or Q2) and be able to attest with your 2011 Edition CEHRT.
The bottom of Figure 1 states, “only providers that could not fully implement 2014 Edition CEHRT for the EHR reporting period in 2014 due to delays in 2014 Edition CEHRT availability.” What does “could not fully implement” mean? If you haven’t purchased an EHR simply because it was too expensive or you haven’t paid your vendor to update (if there is a fee) simply because it is too expense, you cannot exercise any of the options in the Final Rule.
In the Final Rule, CMS specifically discusses numerous elements besides just vendor certification or lack thereof that would allow you to have “not fully implemented”, including:
• Awaiting additional updates to a 2014 CEHRT.
• New version testing by the practice.
• Staff training.
• Workflow modifications.
• “Issues” with your 2014 Edition CEHRT. In fact, CMS states the following:
“However, those providers with 2014 Edition CEHRT installed may also be able to use the options for the use of CEHRT. Again, we stress that an availability delay is not based solely on whether the software is certified and then installed or not, as many commenters questioned. Rather, providers with 2014 Edition CEHRT installed may nonetheless face a 2014 CEHRT availability delay because they are waiting for vendor software updates, or the software itself is presenting problems with functionality, or when the software does not yet contain all required components.”
Finally, CMS has received numerous complaints about the “Providing an Electronic Summary of Care upon a Transition of Care” Stage 2 requirement.
Many are finding it hard to get direct e-mail addresses from the providers to whom they refer their patients and, as a result, can’t meet this measure.
Even if you are using a 2014 Edition CEHRT and were scheduled to meet Stage 2 this year, you are allowed to use Stage 1, 2014 rules instead (which does not include the Summary of Care for Transitions of Care as a Core measure).
Note, however, that you need some documentation to support this option, such as a letter or e-mail from the other provider stating that they don’t have a direct e-mail. OM
Cataract surgery may help patients with dementia
Patients experience improved cognition and elevated quality of life, say doctors.
By Zack Tertel, Senior Associate Editor
While some may view cataract surgery for people with Alzheimer’s disease and other dementias with hesitancy, recent clinical trial results support a slower decline in cognition and improvement in quality of life for patients and their caregivers.
Thomas L. Steinemann, MD, of Metro Health Medical Center in Cleveland and professor of ophthalmology at Case Western Reserve University, says he has experienced tentativeness and lack of enthusiasm from patients’ caregivers and family members as well as some colleagues when discussing cataract surgery for patients with dementia.
“These results show that cataract surgery can have a variety of benefits, both visual and non-visual, for dementia patients and their loved ones,” Dr. Steinemann says. Withholding a discussion about cataract surgery to patients and their family members, based strictly on cognitive decline or impairment, is inappropriate.”
Alan J. Lerner, MD, of Case Western Reserve University and University Hospitals Case Medical Center and colleagues reported interim results from an ongoing clinical trial to determine the effects of cataract removal on visual ability, cognitive measures and quality of life. After evaluating at baseline and six months following recruitment, 20 surgical participants showed significantly improved visual acuity and quality of life, reduced decline in memory and executive functioning and improvements in behavioral measures compared with the group of eight non-surgical participants. Perceived burden for caregivers of patients in the surgical group also showed improvement.
Eye test may detect Alzheimer’s early
Eye examinations may reveal a build-up of a protein associated with Alzheimer’s disease, according to several research trials presented at the Alzheimer’s Association’s International Conference. The studies show beta-amyloid, a protein which begins to build up years before typical Alzheimer’s symptoms present, can be seen in the retinas of patients who have taken a curcumin supplement and using retinal amyloid imaging. For more from the association, see: http://tinyurl.com/ln7mlby.
While Dr. Steinemann says he is realistic regarding the impact of cataract surgery for Alzheimer’s patients, he recognizes that small improvements can have a significant impact on the patients’ lives.
“Even if it’s just as much as providing someone with the ability to see clearly enough to recognize a loved one’s face, I think its worth it,” Dr. Steinemann says.
Dr. Steinemann adds that treating these patients and hearing their positivity following surgery has resulted in an invaluable level of personal satisfaction.
“It has been a gratifying experience to hear from patients and their family members, because I know we’re doing the right thing,” he says.