Avoiding Malpractice Claims

Six preventive steps you can take.

Malpractice claims are traumatic events that can cause feelings of anger and guilt, and even lead to depression. Ophthalmic Mutual Insurance Company and defense lawyers offer these steps to reduce ophthalmologists’ malpractice risks.

1 Have a “bulletproof” informed consent form. You can go to www.omic.com for examples.

2 Never allow anyone to alter a patient record after the fact.

3 Don’t jump to a diagnosis just because it “looks” like something you’ve seen before.

4 Never attempt to re-use a single-use instrument.

5 Always make a same-day follow-up call to your surgical patients.

6 Stay current with new studies and safer techniques. For example, one study suggested wearing a mask and gloves when giving intravitreal injections.

▪ ThromboGenics provides Jetrea update. ThromboGenics recently reported that Jetrea (ocriplasmin), which was approved by the FDA for the treatment of symptomatic vitreo-macular adhesion (VMA) late last year, recorded $16.6 million in US sales through June 30. Jetrea was launched in the United States in mid-January.

ThroboGenics also reported data from a phase 2a study indicating that Jetrea has the potential to resolve VMA in patients with wet AMD. In 100 patients with both wet AMD and VMA, the VMA was resolved in 24% of those who received a Jetrea injection, but in only 12% of the the sham group. The full study results will be presented at the AAO meeting in November.

In other news from ThromboGenics, the company has signed a collaboration and license agreement with Bicycle Therapeutics to develop and commercialize novel drugs inhibiting a specific target for the treatment of DME. ThromboGenics intends to develop therapeutics based on Bicycle’s bicyclic peptides, which inhibit a target involved in vascular permeability. The company says selective inhibition of this target represents a new approach that offers the potential to improve the treatment of DME.

▪ The following correction is noted for the article “Pharmacodynamics Of Visual Cycle Modulation In the Treatment of GA” in the September issue of Retinal Physician (Mata NL et al. 2013;10 (7):22-25):

• The subtitle should read “Emerging data from clinical studies demonstrate the biological activity of emixustat in the retina.” The original wording of the subtitle was generated by the editors of Retinal Physician and not the authors of the article.

Retinal Physician regrets the error.

▪ AMA survey finds private practice still predominates. New data on physician practice arrangements compiled in the AMA “Policy Research Perspectives” series demonstrated that reports of a surge in physician employment by hospitals may be overstated. The AMA survey conducted in 2012 found that 53.2% of physicians were self-employed and 60% worked in practices wholly owned by physicians. This represents a small decrease from earlier studies.

Although the AMA survey gave no specific figures on physician self-employment for ophthalmology, it reported that 71.9% of surgical subspecialists held ownership stakes in their practices. This is the highest level of ownership for any survey category. In contrast, only 37.3% of pediatric physicians and 38.4% of emergency medicine doctors held ownership stakes.

▪ EU approves Eylea for CRVO indication. Regeneron Pharmaceuticals said Eylea (aflibercept) has been approved for the treatment of macular edema secondary to CRVO.

Eylea was approved in the United States for the treatment of wet AMD in 2011 and for macular edema following CRVO in September 2012. Eylea has also been approved in Europe, Japan, Australia and several other countries for treatment of wet AMD.

▪ Mazzo joins Neurotech. Neurotech Pharmaceuticals, a Rhode Island biotechnology company developing proprietary sustained-release therapies for chronic retinal disease, has appointed ophthalmic industry veteran James Mazzo as executive chairman.

Mr. Mazzo, the former CEO of Abbott Medical Optics, is an operating partner at the venture capital firm Versant Ventures and was recently named chairman and CEO of AcuFocus, a Versant portfolio company. As executive chairman, Mr. Mazzo will engage with the Neurotech team to advance the company’s novel technology platform through the clinical development stage toward market commercialization.

Neurotech’s patented core technology platform, Encapsulated Cell Technology (ECT), is a genetically engineered implant that enables the continuous delivery of protein drugs directly into the vitreous of the eye. The company says it has demonstrated that a single living ECT implant can treat a diseased retina for two years or more.

▪ Kala explores topical drug for wet AMD. Kala Pharmaceutical, headquartered in Waltham, MA, is conducting preclinical studies of a topical, mucosal-penetrating formulation of a small molecule receptor tyrosine kinase inhibitor as a potential treatment for a broad range of eye diseases, including wet AMD. The company says it believes mucosal barriers have been largely overlooked as a limitation for drug efficacy.

▪ Argus II qualifies for added Medicare payments. Second Sight Medical Products said its Argus II Retinal Prosthesis System has won CMS approval for both a new technology add-on payment (inpatient setting of care) and a transitional pass through payment (outpatient setting of care) beginning October 1. These payments are designed to support timely access to innovative technologies for Medicare beneficiaries.

According to the CMS, cases involving the Argus II System eligible for new technology add-on payments under the Medicare Inpatient Prospective Payment System will be identified by a new ICD-9-CM procedure code 14.81. Additionally, CMS has also established a transitional pass through payment for Argus II. This payment will be available to all hospital outpatient facilities and ASCs that perform this procedure for Medicare beneficiaries, and will be identified by the 0100T CPT code.

“This news greatly facilitates access to the Argus II for Medicare beneficiaries, regardless of the setting of care in which the system is provided,” said Brian Mech, VP of Business Development at Second Sight.

▪ Orphan drug status for RP therapy. Dompé, a drug-development company based in Milan, Italy, said its investigational drug for the treatment of retinitis pigmentosa (RP) and based on the recombinant human nerve growth factor (rhNGF), has been granted orphan drug designation by the FDA. The drug had several months earlier been awarded similar status in the European Union.