Industry News and Innovations

 

Centers for Medicare & Medicaid Services Release Data on Physician Pay

On April 9, the Centers for Medicare & Medicaid Services (CMS) released data documenting the services provided to Medicare beneficiaries by physicians and other health care professionals and the payments for those services. A database containing information on 880,000 providers, covering payments of $77 billion made under Medicare Part B in 2012, was made available to the public in order “to make our health care system more transparent, affordable, and accountable,” former Health and Human Services Secretary Kathleen Sebelius said in a press release1.

The data released by CMS show that Medicare paid 344 doctors and health care providers more than $3 million in 2012. Of those 344 doctors, 151 were ophthalmologists, who accounted for nearly $658 million in Medicare payments. (For more on this subject, see “Costs and Financial Gain Associated With Glaucoma Therapy” on page 14.)

Like many other associations in organized medicine, the American Academy of Ophthalmology (AAO) immediately responded to the release of the data. In an April 9 press release, the AAO said that the payment data from CMS must be considered in context, that the data as released by CMS are not transparent, and that the database inadequately characterizes physicians’ payments.2

“Ophthalmology has one of the highest practice overhead costs of any medical specialty, including staff, technology, and equipment,” an AAO press release stated. “For many practices, a significant portion of Medicare reimbursement goes to cover these costs, but the payment data released reflect only the gross payments and do not account for those expenses.”

In an interview with Glaucoma Today’s sister publication Retina Today, David W. Parke II, MD, CEO of the AAO, said, “The AAO strongly believes that CMS should have provided us the opportunity to preview the database in order to point out inaccuracies where they existed and issues that might create problems in terms of interpretation. The key issue involves the Part B Medicare data; if Part B pharmaceuticals were eliminated from the equation, there would be far fewer ophthalmologists listed at the top of the reimbursement scale. The AAO holds the opinion that this data release should have been accompanied with material pointing out the limitations within. I fail to see how a claims- based dataset alone can be of any significant value to patients in choosing a physician. I see nothing in these data that can be directly interpreted as useful information on outcomes or quality of care.”

Ophthalmology represents a significant portion of Medicare Part B payments, because the frequency of age-related eye disease is high among patients 65 and older. Some of the most common diseases that may cause blindness, including cataract, age-related macular degeneration, and glaucoma, require treatment by ophthalmologists that can be expensive.

  1. Historic release of data gives consumers unprecedented transparency on the medical services physicians provide and how much they are paid [press release]. https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press- releases/2014-Press-releases-items/2014-04-09.html. Accessed April 15, 2014.
  2. American Academy of Ophthalmology issues statement on release of Medicare physician pay data [press release]. San Francisco, CA; American Academy of Ophthalmology: April 9, 2014.

Careful Gonioscopy Helps Avoid Lawsuits After Laser Peripheral Iridotomy

Patients who experience dysphotopsia and other complications after laser peripheral iridotomy (LPI) can have a bad reaction to the experience, according to Devesh K. Varma, MD. Dr. Varma addressed “how to keep the lawyers at bay” in the case of a missed diagnosis or suboptimal outcome after LPI at Glaucoma Day, held in conjunction with the American Society of Cataract and Refractive Surgery Annual Meeting in Boston in April 2014.1

Dr. Varma said that, in doing research for his talk, he reassessed his fairly aggressive approach to the use of LPI and has since altered his informed consent for the procedure. He urged attendees to go online to Internet forums discussing dysphotopsia in order to see what patients are saying about their experiences. Comments he read on these forums included some from patients wanting to “punch or hit the doctor who did the iridotomies,” Dr. Varma reported.

“Ophthalmology is responsible for $120 million in plaintiff payouts per year in the United States, and those who practice in this country have a 30% risk of a lawsuit over 10 years of practice,” Dr. Varma said. He noted that more lawsuits are brought by women than men and that 65% are brought by people older than 40 years of age. This is significant, he said, because LPI is performed more often on women, and it is performed in 0.7% of people 40 years old or older.

Although a number of potential complications are associated with LPI, including IOP spikes, bleeding, persistent iritis, endothelial cell loss, corneal decompensation, and cataract, the incidence of these events is low, and in most cases—the notable exception’s being corneal decompensation—the complications are easily managed. The incidence of retinal detachment after LPI is in the range of 0.5% to 2%, Dr. Varma said. Part of the reason for the low rate is that retinal detachment is more common in patients with greater axial lengths, and typically, LPI is performed on people with shorter axial lengths, he said.

Several types of dysphotopsia have been described, including glare, halos, ghosting, and lines. Dr. Varma and colleagues at the University of Toronto compared temporal versus superior LPIs in the contralateral eyes of patients and found that the rate of dysphotopsia was 10.7% after superior LPI and 2.4% after temporal LPI. The investigators now use temporal LPIs in all cases, he said.

Possibly more important than these pitfalls of LPI may be the chance of a missed diagnosis of a persistently narrow angle after LPI, Dr. Varma suggested. A greater percentage of lawsuits is brought because of missed diagnoses (33%) than because of surgical complications (23%), he said.

With Ike K. Ahmed, MD, Dr. Varma reviewed almost 1,000 cataract referrals and found that 10.1% had very narrow angles or angle closure. Further, there was a 45% probability of a narrow or closed angle in patients of Asian extraction, with an axial length of less than 23.5 mm, or with an anterior chamber depth of less than 2.9 mm.

As a final comment, Dr. Varma noted that angle- closure glaucoma accounts for 25% of all glaucoma but that it is responsible for 50% of blindness from glaucoma. He said that ophthalmologists who miss angle-closure glaucoma either are not performing gonioscopy after LPI or are performing the procedure in such a way that they are not detecting the condition.

  1. Varma DK. Laser PI: how to keep the lawyers at bay. Paper presented at: The ASCRS Glaucoma Day 2014; April 25, 2014; Boston, MA.

New Appointments for James C. Tsai, MD

James C. Tsai, MD, MBA, has been appointed president of New York Eye and Ear Infirmary of Mount Sinai and chairman of ophthalmology for the Mount Sinai Health System effective September 2014, according to a news release. A world-renowned physician-scientist and administrator, Dr. Tsai will apply his multiple talents to enhance the clinical, scientific, and educational programs of Mount Sinai’s Department of Ophthalmology and continue to secure New York Eye and Ear Infirmary’s reputation as a local, national, and global leader, the news release said.

“The New York Eye and Ear Infirmary of Mount Sinai is one of the leading otolaryngology and ophthalmology hospitals in the world, and we are pleased to welcome a physician of Dr. Tsai’s caliber to lead its inpatient and outpatient services, as well as clinical and research footprint,” Kenneth L. Davis, MD, CEO, and president of the Mount Sinai Health System, said in a news release. “We look forward to having the Department of Ophthalmology and New York Eye and Ear Infirmary of Mount Sinai thrive under his leadership during this time of growth and integration.”

Dr. Tsai is an expert in the diagnosis and manage- ment of challenging glaucoma cases. He specializes in glaucoma implant surgery, trabeculectomy with anti- metabolite surgery, combined glaucoma and cataract surgery, and sutureless cataract surgery in patients with glaucoma. His research interests include the identification of neuroprotective molecules that can shield the optic nerve from damage without lowering IOP, the evaluation of surgical outcomes in glaucoma patients, and the development of advanced vision testing techniques.

A member of Glaucoma Today’s editorial board, Dr. Tsai currently serves as chairman of the Glaucoma Subcommittee of the National Eye Health Education Program Planning Committee of the National Institute of Health, chairman of the American Academy of Ophthalmology’s Global Ophthalmic News & Education Network Advisory Board, chairman of the Medical Advisory Board of the Glaucoma Foundation, and secretary for the English Language Region of the Pan-American Association of Ophthalmology. Before joining Mount Sinai, Dr. Tsai served as chairman of the Department of Ophthalmology and Visual Science in the School of Medicine at Yale University and as chief of ophthalmology at Yale-New Haven Hospital.


Santen to Purchase Merck’s Assets in Ophthalmology

Santen Pharmaceutical has entered into an agreement to purchase Merck’s ophthalmic products (Cosopt, Cosopt PF, Trusopt, Trusopt PF, Timoptic, Timoptic PF, Timoptic XE, Saflutan, and Taptiqom) in Japan, Europe, and Asia Pacific, according to a news release. The annual sales in these territories associated with these ophthalmic products amount to approximately $400 million.

Under the terms of the agreement, Santen will make an upfront payment of approximately $600 million and additional payments based on defined sales milestones as needed. Santen will also receive from Merck the ophthalmic products within this agreement for a 2- to 5-year period. The agreement is subject to certain closing conditions, including obtaining antitrust clearance in Japan and others related to specific markets or regions. Santen intends to fund the transaction with a combination of cash on hand and bank loans. The agreement is expected to close in a few months.

“Santen is proud to inherit and continue Merck’s formidable legacy in ophthalmology,” Akira Kurokawa, president and CEO of Santen, said in a news release. “This transaction strengthens Santen’s lineup of glaucoma products, significantly expands Santen’s footprint in Japan, Asia, and Europe, and is an important step in achieving its long-term corporate vision to become ‘a specialized pharmaceutical company with a global presence’ by 2020. We are pleased that, by entering into this agreement, Santen can increase its presence in the global ophthalmology market, which consequently allow[s] us to contribute even further to meet the medical needs of the patients suffering from various eye disease[s].”

According to the news release, Santen’s income is expected to increase in connection with this agreement, and thus its earnings per share are expected to increase from fiscal period ending in March 2015.


Amakem Initiates Phase 2 Dose-Ranging Study for Locally Acting ROCK Inhibitor

The first patients have commenced treatment for glaucoma in Amakem Therapeutics’ phase 2 dose- ranging study of its lead drug candidate, AMA0076, according to a news release.

AMA0076, a highly potent Rho-kinase (ROCK) inhibitor based on Amakem’s localized drug action platform, has been designed to reduce IOP by acting specifically on the main outflow system in the eye while minimizing side effects such as hyperemia. This clinical sign has reportedly been seen with other ROCK inhibitors developed for glaucoma.

The phase 2 trial is a multicenter, randomized, double-masked, placebo-controlled study with an optimized formulation of AMA0076 applied topically as eye drops. The company aims to enroll approximately 80 patients in the United States.

The primary efficacy endpoint will be the change in IOP from baseline at the end of 28 days of treatment. Secondary endpoints include IOP assessment at other time points as well as safety and tolerability assessments. Amakem expects to report top-line results in the fourth quarter of this year.

AMA0076 was previously shown to reduce IOP without causing significant hyperemia in a first-in-human study in patients with glaucoma and ocular hypertension. An optimized formulation with significantly improved corneal absorption substantially decreased IOP with no significant hyperemia in a subsequent phase 1b study, according to the company.

“AMA0076 has demonstrated IOP reduction without significant hyperemia, the first ROCK inhibitor to achieve this goal in the clinic,” Jack Elands, PhD, CEO of Amakem, said in a news release. “The experience we gained in our first-in-human study and the subsequent clinical evaluation of our new formulation gives us great confidence as we begin this dose-ranging study.”

“Glaucoma remains a significant cause of vision loss and blindness and affects many millions of people worldwide,” Steve Pakola, MD, chief medical officer of Amakem, said in a news release. “Using ROCK inhibition to increase the outflow of aqueous humor from the eye represents a target for glaucoma therapy whose promise is widely recognized. However, development has been held back by the side effect profile of ROCK inhibitors, particularly hyperemia. In AMA0076, we believe we have a candidate that can fully harness the potential of this mechanism of action and thereby provide a potential treatment alternative for this prevalent and serious condition where current treatments do not address the needs of many patients.”


OcuTherix Teams up With the University of Colorado to Develop a Noninvasive Glaucoma Procedure

OcuTherix and the University of Colorado (CU) have completed an exclusive license that will allow the company to continue developing a noninvasive procedure for the treatment of glaucoma that uses patent- pending technology developed at CU, according to a news release. A research team led by Malik Kahook, MD, Slater family endowed chairman in ophthalmology at the CU School of Medicine, has developed a compact, noninvasive device that reportedly uses carefully calibrated external sonic oscillation to stimulate drainage of the eye’s fluid, thereby reducing IOP. This innovative procedure, called “deep wave trabeculoplasty” (DWT), is intended to be an efficient, safe, and effective in-office treatment.

According to a news release, DWT does not damage tissue and consistently lowers IOP. An ongoing clinical study will determine whether DWT has long-lasting benefits and can be repeated when needed.

“The initial DWT study in humans revealed consis- tent eye pressure lowering without adverse events,” Dr. Kahook said in a news release. “Our team believes that DWT will play a significant role in the treatment of glaucoma in the United States and across the globe.”

“Gradual vision loss is devastating, and I am proud to be working with outstanding partners to develop DWT as we strive to save vision in people with glaucoma,” OcuTherix CEO Robert Atkinson said. “I strongly believe that DWT represents a new age in glaucoma treatment.”


ICE Outcomes Promising for Patients With Open-Angle Glaucoma

eyetube.net/?v=ipepu

Combining the iStent Trabecular Micro-Bypass Stent (Glaukos) with endocyclophotocoagulation in a procedure called ICE is a promising low-risk therapy for eyes requiring more aggressive glaucoma treatment, according to data presented by Nathan Radcliffe, MD, at the American Society of Cataract and Refractive Surgery Annual Meeting in Boston (see Dr. Radcliffe’s interview with Eyetube.net and the article by Steven R. Sarkisian Jr, MD, on ICE on page 26).1

The study included 70 patients (34 had previous glaucoma surgery) with moderate open-angle glaucoma requiring cataract surgery. All patients underwent phacoemulsification, implantation of one iStent, and endoscopic cyclophotocoagulation. The mean preoperative IOP was 19.4 ±5.5 mm Hg. At the preoperative examination, 85.7% of the patients were on glaucoma medications. Of these, 58.6% were on two or more glaucoma medications.

In 48 of 70 eyes observed for 3 to 6 months postoperatively, the mean IOP decreased to 15.8 ±3.1 mm Hg. Almost half (47.9%) of the eyes had a reduction in IOP of 20% or greater, and just over 20% (20.8%) had an IOP reduction of 40% or greater. At the 3- to 6-month examination, over half of the eyes had an IOP of 15mm Hg or less.

Of the 48 eyes, 33.6% no longer required glaucoma medications, 39.6% were on one medication, and 26.8% were on two or more medications.

According to Dr. Radcliffe, BCVA generally improved postoperatively. There were no operative complications, hypotony, or reports of typical complications associated with filtration surgery. One patient was noncompliant with medical therapy and underwent a trabeculectomy, and one patient underwent iridotomy for obstruction of the stent.

  1. Radcliffe N, Noecker R, Parekh P, Sarkisian S. ICE surgical technique outcomes: MIGS implantation of trabecular bypass stent, cataract extraction, and endoscopic cyclophotocoagulation. Paper presented at: The ASCRS Glaucoma Day 2014; April 25, 2014; Boston, MA.

Glaucoma Pioneer Michael Belkin, MD, Joins iStar’s Scientific Advisory Board

iStar Medical announced the addition of Michael Belkin, MD, to its Scientific Advisory Board, according to a news release. Dr. Belkin is professor emeritus of ophthalmology at Tel-Aviv University, where he is the director of the Ophthalmic Technologies Laboratory at the university’s Eye Research Institute, located at the Sheba Medical Center in Israel. Dr. Belkin also serves as senior advisor to the Singapore Eye Research Institute. Dr. Belkin has been involved in the establishment of over 15 medical start-up companies in ophthalmology and other fields. Among his noted contributions to the field of glaucoma surgery is the invention of the Ex-Press Glaucoma Filtration Device (Alcon) in 1998.

“Dr. Belkin brings over 40 years of experience in the study and treatment of glaucoma and understands the growing need for next-generation implant devices to improve outcomes and quality of life for patients,” Michel Alvarez, CEO of iStar, said in a news release. “The team is very pleased to have a pioneer in the field contribute to our robust product pipeline, and we look forward to working with him.”

“Glaucoma should be considered as a surgical disease in view of the failure of drug therapy to eliminate glaucoma blindness and visual impairment even where ophthalmic care and drugs are available,” Dr. Belkin said in a news release. “A safe, simple surgery with long- lasting IOP-lowering effect will contribute considerably to reducing glaucoma morbidity, both in locations where ophthalmic treatment is plentiful and where it is not.”

 

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Glaucoma Today is mailed bimonthly (six times a year) to 11,519 glaucoma specialists, general ophthalmologists, and clinical optometrists who treat patients with glaucoma. Glaucoma Today delivers important information on recent research, surgical techniques, clinical strategies, and technology.