This article was reviewed by Donny Won Suh, MD 


	
	Results from the Hyperopia Treatment Study 1 (HTS1) have proven to be inconclusive after three years of follow-up in young children with moderate hyperopia treated with glasses compared with observation. A small-to-moderate benefit or no benefit of immediate glasses was seen compared with observation. 
	
	The study rationale was that 4% to 14% of children have moderate to high levels of hyperopia, a scenario that carries a significantly increased risk for development of strabismus and amblyopia. Based on previous studies, it is controversial whether glasses should be prescribed immediately for children with moderate myopia to prevent amblyopia and strabismus from developing.
	
	The alternative is observation until signs of decompensation become apparent followed by prescribing of glasses, according to Donny Won Suh, MD, chief of pediatric ophthalmology, University of Nebraska Ophthalmology, Children’s Hospital and Medical Center, Omaha.
	
	

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	Dr. Suh and Marjean Kulp, MD, were protocol chairpersons of the HTS1 that sought to determine the visual acuity (VA) and alignment benefits, if any, of immediate eyeglass prescription compared with observation for children from 1 to less than 3 years of age who had +3.0 to +6.0 D of hyperopia after a follow-up period of three years.
	
	The 106 study patients with anisometropia and mild astigmatism and no apparent strabismus were randomly selected to either having eyeglasses prescribed immediately or observation and followed every six months for three years. During follow-up, if decompensation became apparent in the observation group, glasses and other appropriate treatments were prescribed.
	
	Criteria included decreased distance VA, decreased stereoacuity, and heterotropia. During follow-up, investigators were alert to any signs of permanent damage.
	
	

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	Failure was not the same as deterioration, Dr. Suh noted. Failure was defined at the end of the study and had to be confirmed both in and out of refractive correction to answer the question about whether harm had been done by waiting to prescribe glasses or other treatments. On the other hand, deterioration could have occurred at any follow-up examination before the end of the study and defined in randomized treatment.
	
	The criteria to define deterioration were as follows during unmasked testing in randomly selected correction and confirmed during retesting by a masked examiner: 


	
	> Measurable heterotropia;
	> Presence of a VA or stereopsis below age-normal values in patients 3 and older,
	> Significant, or marked parental concern.

When deterioration was identified, cycloplegic refraction was performed and new glasses were prescribed if patients were under observation. For patients randomly selected for eyeglasses, a full cycloplegic refraction was performed to determine if the esotropia improved. The patients then were released to receive care that included patching, atropine, and/or surgery and followed.
	
	In the primary study, failure was defined as harming the VA, stereoacuity, or alignment, in the presence of the following with/without trial frames and then confirmed by a masked test and retest: measurable heterotropia, VA and stereoacuity below age-normal values, or a previous strabismus surgery, Dr. Suh explained.
	
	

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	Dr. Suh reported that 34% and 21% of patients, respectively, failed in the observation group and the glasses group, a difference of -13% (95% confidence interval, -31%-4%).
	
	“The results mean that if the study was repeated in a similar population, the difference can be up to 31% and in favor of eyeglasses,” he said. “However, the other extreme was also possible, with 4% in favor of observation. There was no significant difference in the failure rate at three years between the two groups.”
	
	Patients who failed at three years did so because of failure of stereoacuity. Failure occurred in 30% in the observation group and 10% in the glasses group. The results for strabismus and VA were similar.
	When patients were analyzed by different degrees of hyperopia, +2.5 to <+4.0 D, +4.0-+5.0 D, and >+5.0-+6.07 D, a greater difference was seen in the low hyperopia group, with about 30% failing observation and about 10% failing glasses, Dr. Suh noted.
	
	Regarding deterioration before three years, 33% deteriorated in the glasses group and 58% in the observation group. “This was the expected finding before the study,” he said.
	
	The reasons for deterioration were similar to those for failure, with the observation group having greater deterioration than the glasses group.
	
	Analysis on the effect on emmetropization at three years showed that the patients in the observation group had a very slight nonsignificant decrease in hyperopia, 0.16 D.
	
	The first key take-home point was that 58% of the observation group met the criteria for deterioration, in that they required glasses. About 50% had been followed for three years without signs of deterioration in VA, stereopsis, and strabismus.
	
	The second take-home point showed that the failure rates in the two groups did not differ significantly, but there was a 13% difference favoring glasses.
	
	“For children who are from 1 to 3 years of age with uncorrected moderate hyperopia (+3 to +6 D spherical equivalent), our estimates of failure after three years of every six-month follow-up did not allow definitive recommendations,” Dr. Suh concluded. “However, the results were consistent with a small-to-moderate benefit or no benefit of immediate glasses compared with careful observation, with glasses if deterioration occurs. Further studies are needed to answer the question.”
	
	

Dr. Suh has no financial interest in this technology. This study was sponsored by the National Eye Institute.

Articles

Glasses eyed as treatment in children 

This article was reviewed by Michael B. Rivers, MD 


	
	Burnout is a problem that is not going away. As retina surgeons become increasingly busy, operating their practices more efficiently is a key to success.
	
	Seeing patients is only a part of the process. Physicians have to manage their practice, and this includes inventory management, and providing value-based care.
	
	With so many balls in the air at the same time, retina specialists become susceptible to burnout.
	
	According to Michael B. Rivers, MD, retina surgeons often see 90 to 100 patients a day, making it extremely difficult for them to take time off, or even keep up with other practice needs. This phenomenon is not unique to retina specialists.
	
	Dr. Rivers, director, EMA Ophthalmology, at 

, noted as retina practices have become larger, an increase in patient volume has become an issue as physicians have seen their practices change.
	“Along came the ability to treat wet macular degeneration,” he explained. “That was a huge change for retina practices. These patients that you would normally see once a year and you wouldn’t have any treatment for them, you were suddenly seeing them once a month.”
	
	As a result, the volume of patients began to increase almost overnight.
	
	Dr. Rivers recounted a physician he recently visited who sees more than 120 patients a day. The visits do not require a lot of decision making.
	
	“This contributes to burnout because it is not intellectually challenging,” he said. “They have no control over their lives.”
	
	Some physicians may take more vacation, but when they return from vacation, the patients still need to be seen.
	
	“It is a real change if you have moved to a surgical practice with a few patients to a tremendous number of patients,” Dr. Rivers added.
	
	

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	Another change, according to Dr. Rivers, has been the advent of electronic health records (EHR).
	
	“You have this burden of documentation for the federal government with software that isn’t designed to help the physician as a provider,” he said.
	
	Dr. Rivers left his practice to join Modernizing Medicine, which offers physicians solutions to many of the problems connected to the daily operation of a practice.
	The company was founded in 2010 by Daniel Cane and Michael Sherling, MD, MBA.
	
	The goal, according to Dr. Rivers, is to make it easy to enter data into the company’s system and also to deliver data back to the clients.
	
	“Everything we do is to make it easier for clinicians,” he said. “We also want to get them more information.”
	
	Physicians can operate more efficiently with software that is easy to use with an app that is graphically oriented. Users can dictate rather than type.
	
	“We also try to provide as much functionality as possible so that the software learns what types of things you do and presents information to you so things are easier,” Dr. Rivers said.
	
	The software allows physicians to focus on diabetic retinopathy and wet macular degeneration. It also allows physicians to communicate with patients.
	
	“Information can be printed out and handed to the patients,” Dr. Rivers said. “We also have a patient portal and additional patient engagement tools such as automated appointment reminders and surveys.”
	This will lead to an increase in information for both patients and physicians and improved communications. 
	
	


	Drug inventory is key for a retina practice and the drugs used to treat wet macular degeneration and diabetic issues are expensive. The physicians have to purchase medications up front and track it and ensure it is assigned to the right patient and billed correctly.
	
	“Drug inventory software is a very important part of the documentation process with electronic health records,” Dr. Rivers explained.
	
	Optical and ASC inventory also are key for physicians.
	
	Drug inventory management is a large burden for any practice. A retina specialist may buy $500,000 in inventory each year.
	
	“That is a tremendous amount of money,” Dr. Rivers said. “Even a few percent loss can add up to a tremendous amount of money.”
	
	Automation can be key to successful inventory practices, and can ensure efficient flow.
	
	Patients benefit from anything that helps the physician work more effectively. These efficiencies can help physicians operate more efficiently and spend more time with patients.
	
	Through the automated systems, drugs are billed correctly through insurance. Dr. Rivers noted that automation and software design for drug inventory is critical to the retina practice.
	
	

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	Over the last decade or so, trends have moved from paying for care because it has been delivered to understanding the quality of care that is provided.
	
	“Value based care as a concept is to say that you want to provide cost-effective care and understand outcomes,” Dr. Rivers said. “Not only am I paying for something, if I am a payer or the federal government, but I also want to understand what value is being provided to patients for every dollar that I put in.”
	
	It can be another level of burden for physicians, who traditionally have billed patients because services were provided.  Now insurance companies want documentation about why something is happening and the value of a procedure for patients and whether standard procedures are followed.
	
	If insurance providers tell a physician they have to provide outcome data on their patients with macular degeneration, the automated system allows them to deliver the information from the EHR.
	“Our software is easy to get data in but we also have analytics in our package where data analysis is delivered to the client,” Dr. Rivers noted. “If I want to find patients who have been treated with wet macular degeneration with a specific drug and what the outcomes are, I can do that. That is very powerful.”
	
	The software allows physicians to access data on specific diagnoses as well as treatment algorithms and associated costs. This enables them to make financial decisions, and also provide data to payers.
	“True value based healthcare is understanding clinical success, outcomes and the financial cost,” Dr. Rivers said. “This allows physicians to understand their costs. The business of medicine is like any other business. The more information you have, the better decisions you can make.”
	
	When practices are successful, they run more efficiently, and can have more physicians and staff. The end result is shorter wait times and a staff that is more engaged.
	In the field
	
	Ajit Nemi, MD, MBA, Lotus Vision, Atlanta, GA, noted that it took a few weeks to get acquainted with the system, but he, along with his technician, have become more efficient with creating and finishing notes. It helps with efficiency.
	
	“The available plans are detailed and fully customizable and I don’t have to do much data/text entry,” he explained. “I am actually able to leave the office earlier than I was able to before. As a cornea, cataract and refractive surgeon, I appreciate the comprehensive counseling information and treatment protocols for the diagnoses I most commonly encounter.”
	
	Dr. Nemi noted that the system allows him to create operative reports for anterior segment procedures with the touch of a button, eliminating the need to dictate reports over the phone.
	
	“EMA also provides specific charting protocols for post-operative patients that allow the physician to complete notes efficiently while automatically generating the appropriate codes and modifiers for the postop period,” he said.
	
	Erik W. Niemi, DO, Advanced Eyecare, PC, Bennington, VT, noted that the EMA has made the practice’s communications and documentation more efficient than ever.
	
	“The system is intuitive, with a clean layout and user interface that makes information easy to find,” he said. “For routine communications, I can complete and send custom preset letters to a primary care physician before leaving the exam room. We also have much easier on-call access to patient data as our physicians in any office can read each other’s notes instead of relying on the patient’s explanation.”
	
	In the field, Dr. Rivers noted that physicians are finding the software is helping them operate at peak efficiency.
	
	“When a practice is running efficiently, it can provide better care,” Dr. Rivers said. “That is a win for the physician and for the patient. You can have humans talk to patients, and that is what is important.
	
	

Dr. Rivers is director, EMA Ophthalmology for Modernizing Medicine. He has no other financial disclosures. 

Technology makes physicians more efficient, reduces burnout 

This article was reviewed by George A. Williams, MD


	
	For ophthalmology practices, drug prices continue to be an issue for patients, and step-therapy and pre-authorization are responses to increasing drug costs, which exceed any other component of healthcare.
	
	While inflation is less than 2% per year, name brand drug price increases reach double digits year after year, according to George A. Williams, MD, president of the American Academy of Ophthalmology.
	That leaves industry leaders to wonder why.
	
	The argument has always been that it is expensive to develop drugs, to innovate and invest in necessary research, said Dr. Williams. who also is chairman of ophthalmology at Oakland University. “Although true, the real relationship between marketing and administrative costs for pharmaceutical companies compared with what they spend on research is approximately two to one,” he said. “Worldwide and during the past decade, there has been a static relationship between research investment and sales, averaging around 15% to 18%.”
	
	


	The FDA approves about 200 new drugs every year, with only 15 to 50 classified as new molecular entities, or NMEs. The FDA says that NMEs contain active moieties that have not been approved by the FDA previously, either as a single ingredient drug or as part of a combination product.
	
	“Some drugs are characterized as NMEs for administrative purposes, but nonetheless contain active moieties that are closely related to active moieties in products that have previously been approved by FDA,” according to the FDA website.
	
	One reason for this gap could be the U.S. patent system, Dr. Williams said.
	
	Experts have argued that drug prices keep increasing because pharmaceutical companies are running out of new agents that can command premium prices. One detailed analysis reveals that as some higher-end drugs come off-patent, manufacturers have responded by increasing the price of drugs that remain on patent. 
	
	“The system is set up to generate profits, not research and innovation,” Dr. Williams said. 
	
	The majority of the costs are attributable to a relatively small number of drugs, he explained.
	
	“For Medicare Part B and Part D-where glaucoma patients live-the per capita growth rate for drug cost is 10% per year. Profit margins for the top 25 drug makers are robust, and these companies have consistently doubled the profit margins of all other companies in the Fortune 500,” Dr. Williams said.  “There appears to be bipartisan support for addressing this issue.”
	
	

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	Pre-authorization, familiar to all physicians and ophthalmology practices, can involve drugs, devices or surgery. It is granted about 90% of the time, but it is still an impediment to patients’ access. This has piqued the interest of Congress, and the AAO has been advocating for standardization with follow-through in the pre-authorization environment.
	
	


	“Step-therapy, a potential game-changer in the drug space, comes from the Centers for Medicare and Medicaid Services decision to allow Medicare Advantage (MA) plans the option of implementing step-therapy across all Part B drugs, including off-label compounded treatments,” Dr. Williams said.
	
	Many questions remain, however, such as: What constitutes a trial or treatment failure? How much vision does the patient have to lose (or not gain)? What happens with the fellow eye?
	“These questions create access issues for patients,” Dr. Williams said. “The Academy has been involved in step-therapy for years and will continue to speak to policy makers about the need for consistent, patient-centered coverage policies.”
	
	There remains significant variation in coverage, however, and only 16% of drug indications are covered by all plans, Dr. Williams noted.
	
	


	
	A comprehensive analysis indicates that less than half of drug indications are covered by 75% or more of commercial carriers. Prescribing protocols are consistent with the FDA label barely half of the time; they are more restrictive a third of the time; and 5% of the time there is no coverage even when FDA approved, according to Dr. Williams.
	
	The AAO has written to the CMS expressing concern about the impact this has on patients’ access to care, Dr Williams noted. Changes to MA, according to a recent Office of the Inspector General report, may incentivize payers to deny access to services and payment in order to increase the profit of these private companies. In fact, 75% of the denials the MA plans implement that are appealed are reversed, but only 1% of the denials were actually appealed.
	
	The OIG concluded that “this is especially burdensome for beneficiaries with urgent health conditions.” This issue is likely to become more significant with the continuing expansion of MA. In 2018, 35% of Medicare beneficiaries were in Medicare Advantage with some states as high as 60%, Dr. Williams said.
	
	

Lack of Medicare coverage leads to less eyeglass use, study finds


	One possible solution is to have Americans pay what other countries pay.
	
	“In the United States, we pay approximately 80% more for all drugs-in the retina space, it is substantially more.” Dr. Williams said. “With Medicare part D, patients pay the first $415. Medicare pays 75% of the next 3,800. After that, patients go into the donut hole.”
	
	The ever growing gross-to-net rebate bubble is the difference between the manufacturer’s list price and the net price, after negotiated rebates and discounts decided by pharmacy benefit managers (PBMs). Last year, it was $166 billion.
	
	“This can produce perverse incentives for drug companies to raise  prices and increase discounts, because PBMs are paid by insurers based on the amounts they negotiate for each discount,” Dr. Williams concluded. “These discounts are supposed to be shared with either the insurance provider or with the patient-but it turns out they are not, and our patients pay co-pays on the inflated price. This rebate bubble has exploded in recent years, from $59 billion in 2012 to $126 billion currently.”
	
	


	p: 248/288-2280 
	e: George.Williams@beaumont.edu
	

This article was adapted from Dr. Williams’ presentation at the 2019 American Glaucoma Society annual meeting. Dr. Williams has no other financial disclosures related to this report.

Vol. 44 No. 14

Glasses eyed as treatment in children

Technology makes physicians more efficient, reduces burnout

New battles taking place in fight to control drug costs

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