A weekly e-journal by Art Epstein, OD, FAAO


Volume 18, Number 30

Monday, July 23, 2018


Inside this issue: (click heading to view article)
######### Off the Cuff: VSP PROPOSED LEGISLATION - Take Action Before It’s Too Late
######### Compliance To Topical Anti-Glaucoma Medications Among Patients At A Tertiary Hospital In North India
######### Physical Activity, Cardiorespiratory Fitness, and Incident Glaucoma
######### Effects Of Ripasudil, A ROCK Inhibitor, On Retinal Edema And Nonperfusion Area In A Retinal Vein Occlusion Murine Model
######### News & Notes

Click on the image for upcoming Conferences and Meetings.


Off the Cuff: VSP PROPOSED LEGISLATION - Take Action Before It’s Too Late

Craig Steinberg and I have been friends for many years. If you don’t know Craig or his work, you should. In addition to being an OD, he is also among the most knowledgeable and active lawyers representing optometry and optometric interests. I don’t know anyone more devoted to the profession or an individual who is more of a straight shooter than Craig. Much of his work involves representing ODs when they run afoul of VSP and other insurers. I have given Craig my weekly space to share some urgent and ominous news about VSP. I urge you to heed his words and call your state association and the AOA to ask that they take action to stop this proposed legislation before it seriously harms the profession. By as soon as early August it may be too late. Act now!

Arthur B. Epstein, OD, FAAO
Chief Medical Editor

A Warning
By Craig S Steinberg, OD, JD

Vision care plans are an important and largely inescapable part of most optometric practices. There is no denying it. And VSP is, unquestionably, the most important for many practices. That’s not surprising, as VSP provides vision care coverage to about 80,000,000 people in the United States, and about 35,000 eye care providers are contracted with VSP. What might surprise you, however, is that, no matter where you live or practice, if you are contracted by VSP and you have a dispute with them or are audited by them, that dispute or the outcome of that audit will be settled based on California law.

You may wonder: how can that be? Well, it’s simple. Every doctor contracted with VSP signs a Network Doctor Agreement (an NDA). That NDA contains a common provision called a choice of law clause, and it says that California law applies to the interpretation or enforcement of the NDA, or to any dispute arising out of it. Does it really matter that much? Yes, it does. It matters because, as I write this, VSP is advancing legislation in California—known as AB 1092—that, if passed, will govern VSP’s process for resolving disputes, including audit outcomes. And, because your NDA says California law applies, that means AB 1092 will govern disputes and VSP audits no matter where you practice.

AB 1092 does two important things. First, it gives VSP the right, by law, to determine how much you owe them for any alleged overbilling by using sampling and statistical extrapolation. VSP will be allowed to examine only a few records, usually only about 12 to 15 records from any given year, and from that small sample determine that you owe them potentially hundreds of thousands of dollars. While VSP has been using this process for some time, the California Department of Managed Health Care, which regulates VSP, recently ruled that VSP was never authorized to use sampling and extrapolation. Through AB 1092, VSP wants to pass a law that prevents you from challenging their right to use this methodology. Though Medicare and Medicaid are allowed to do this, I’m not aware of any private insurer in the country that can, because it is inherently inaccurate, and it prevents you from using your actual records, other than the sample records chosen by VSP to audit, to prove you were not overpaid.

But, AB 1092 doesn’t stop there. It also prevents you from ever obtaining a judicial review of a VSP audit. Instead, AB 1092 forces you into a binding arbitration process under rules written by VSP. These rules are so favorable to VSP that, in February 2017, a United States Federal Judge in Sacramento issued an injunction against VSP using arbitration in a dispute with a doctor, ruling that the VSP arbitration procedure was probably illegal and likely so unfair that it was unconscionable.

The California Optometric Association (COA) has taken a “neutral” position on this bill—tantamount to support. Without any meaningful investigation, such as interviewing doctors that have actually been audited, they say the bill only applies to the “most egregious” cases of fraud by a provider, and not to “billing disputes.” Sadly, the COA has drank VSP’s proverbial Kool-Aid. VSP considers any adverse finding by its fraud investigators to be proof of “fraud.” That includes failing to adequately document that materials were dispensed (even if they were, in fact, dispensed), inadequate documentation of a contact lens fitting and even failing to find a chart at the time of the audit. VSP has a very broad definition of “fraud.” And, to rub salt on the wound, because the new law does not allow you to defend yourself in court, the only way you can prove you should not be forced into VSP’s unfair dispute resolution process is through VSP’s unfair dispute resolution process!

Many of us are dependent on vision care plans, and VSP in particular, in our practices. We work hard to provide great care for our VSP patients, often at levels of reimbursement that hardly cover our costs. Hopefully the AOA and our state associations will look carefully at what VSP is proposing in AB 1092 and protect the interests of their members by gaining a thorough understanding of the real implications of this legislation—independent of what VSP is telling them. Every state association should encourage the COA to oppose this bill, at least until they have carefully—and thoroughly—investigated its implications for almost every private practice optometrist in the United States. I urge you to ask your association and the AOA to contact the COA and ask them to block this bill from becoming law until it can be carefully evaluated, and its real impact fully understood.


Want to share your perspective? Write to Dr. Epstein at artepstein@optometricphysician.com.

The views expressed in this editorial are solely those of the author and do not necessarily represent the opinions of the editorial board, Jobson Medical Information LLC (JMI), or any other entities or individuals.



Compliance To Topical Anti-Glaucoma Medications Among Patients At A Tertiary Hospital In North India
The present study aims to estimate the prevalence of non-compliance and improper drop administration technique among glaucoma patients and describe common obstacles to medication compliance. A hospital-based cross-sectional study, using a standardized questionnaire and direct observation by study personnel, was conducted among glaucoma patients aged 18 years and above at a tertiary care charitable eye hospital in North India. Researchers recruited 151 consecutive glaucoma patients on medical therapy with follow up at the glaucoma clinics for at least six months. Non-compliance was defined as missing at least one drop of medication per week and (or) the inability to accurately describe the medication regimen. Study personnel also assessed drop administration technique during application by patients treating ophthalmologist-provided information, including measures of disease stability. Factors such as socioeconomic status, presence of caregiver and number of medications with their effect on compliance were studied using chi-square statistics.

Among the 151 patients interviewed, around 49% reported problems using glaucoma medications, with 16% of them reporting total non-compliance. Forgetfulness was cited as the main reason for being non-compliant and had a significant association with non-compliance. Paying patients were more compliant compared with subsidized patients. Disease was more stable in compliant patients compared with non-compliant patients. No other factor had significant association with compliance.

More than 50% of the patients surveyed were non-compliant, and 35% demonstrated improper administration technique. Glaucoma patients should be educated on the importance of compliance and aids that minimize forgetfulness, and clinicians should consider systems facilitating the delivery of medications to the eye to enhance patient adherence.

SOURCE: Rajurkar K, Dubey S, Gupta PP, John D, Chauhan L. Compliance to topical anti-glaucoma medications among patients at a tertiary hospital in North India. J Curr Ophthalmol. 2018;30(2):125-129.

Physical Activity, Cardiorespiratory Fitness, and Incident Glaucoma
This study examined the associations of physical activity and cardiorespiratory fitness (hereafter fitness) with incident glaucoma in a prospective observational study. Physical activity was measured by self-reported leisure-time activities, and fitness was measured by maximal treadmill test. Incident glaucoma was defined based on physician diagnosis. Participants included 9,519 men and women between the ages of 40 and 81 years (mean age of 50) who were enrolled in the Aerobics Center Longitudinal Study. Hazard ratios were estimated using Cox proportional hazard regression after adjusting for age, sex, race, examination year, smoking status, heavy alcohol drinking, hypertension, hypercholesterolemia, abnormal electrocardiogram, diabetes, cardiovascular disease and cancer.

A total of 128 cases of incident glaucoma were reported during a mean follow-up of 5.7 years. A significantly lower risk of incident glaucoma (hazard ratio [HR] 0.53, 95% confidence interval [95% CI] 0.35-0.79), was found in individuals who met the physical activity guidelines of ≥500 metabolic equivalent-minutes (MET-min) per week compared with inactive individuals (0 MET-min/week). Compared with low fitness (lower third), individuals with high fitness (upper third) also had a significantly lower risk of incident glaucoma (HR 0.60, 95% CI 0.38-0.95). A joint analysis of physical activity and fitness showed that meeting physical activity guidelines and being in the high fitness category was associated with the lowest risk for developing glaucoma (HR 0.49, 95% CI 0.31-0.79).

This study provides epidemiological evidence that meeting physical activity guidelines or being fit reduces the risk of developing glaucoma.

SOURCE: Meier NF, Lee DC, Sui X, Blair SN. Physical Activity, Cardiorespiratory Fitness, and Incident Glaucoma. Med Sci Sports Exerc. 2018 Jul 6. [Epub ahead of print].


Effects Of Ripasudil, A ROCK Inhibitor, On Retinal Edema And Nonperfusion Area In A Retinal Vein Occlusion Murine Model
Rho-associated coiled-coil containing protein kinase (ROCK) inhibitors are used to treat glaucoma patients and have protective effects on ischemic states. However, it is poorly understood how the ROCK pathway affects the pathological signs of retinal vein occlusion (RVO). In this study, researchers evaluated the effects of ripasudil, a ROCK inhibitor, on a murine RVO model. In vivo, RVO was induced by retinal vein laser irradiation in mice, and evaluated after treatment with ripasudil. In vitro, the effects of ripasudil were examined on tight junction protein integrity in human retinal microvascular endothelial cells (HRMECs). Moreover, they investigated the expression level of the phosphorylated myosin phosphatase target protein (MYPT)-1 after administration of ripasudil.

Ripasudil significantly prevented deterioration, such as retinal edema, reduced the size of the nonperfusion area and improved retinal blood flow. Ripasudil treatment inhibited disintegration of ZO-1 in HRMECs.

Administration of ripasudil suppressed retinal phosphorylation of MYPT-1 in the murine RVO model. These findings indicate that ripasudil might be a possible therapeutic agent for RVO.

SOURCE: Hida Y, Nakamura S, Nishinaka A, et al. Effects of ripasudil, a ROCK inhibitor, on retinal edema and nonperfusion area in a retinal vein occlusion murine model. J Pharmacol Sci. 2018 Jun 19. [Epub ahead of print].

News & Notes

X-Cel Specialty Contacts Announces Scleral Lens Patient Care Kits
X-Cel Specialty Contacts recently launched the Atlantis Scleral patient kit— a travel-sized compact kit designed to assist the scleral lens patient in keeping their supplies easily accessible and organized. Each mirrored kit contains application and removal tools, unpreserved saline solution and a contact lens case. The kits are an excellent addition to the practitioner’s scleral lens package and are now available to eye care professionals through any X-Cel location. Read more.

Oyster Point Pharma Announces Positive Results from Phase 2 Clinical Trial of the Company’s Investigational Treatment for Dry Eye Disease
Oyster Point Pharma, Inc., recently revealed results from the PEARL study, a Phase 2b clinical trial evaluating the company’s novel therapy for the treatment of dry eye disease (DED). The study met both sign and symptom primary endpoints by showing a statistically significant improvement in each compared to a vehicle control.

The study evaluated OC-02, a nicotinic acetylcholine receptor (nAChR) agonist the company is developing to treat the signs and symptoms of DED. The OC-02 compound is delivered as a nasal spray and stimulates the trigeminal parasympathetic pathway to activate the glands responsible for producing the eye’s natural tear film.

The study was a dose-ranging, randomized, double-masked, vehicle-controlled clinical trial that evaluated the safety and efficacy of OC-02 in 165 subjects with DED at US centers. Primary endpoints included the assessment of tear production as measured by Schirmer’s score, which is a test of the eye’s ability to produce tears, and patient-reported symptoms of DED as measured by the validated Eye Dryness Scale (EDS) under adverse conditions. The study compared three different doses of OC-02 to a vehicle control nasal spray. Results indicated a clear dose-response in production of tear film as measured by a statistically significant improvement in Schirmer’s score in all three doses tested compared to a control. Read more.

RGN-259 (Tβ4) Improves Clinically Important Dry Eye Efficacies in Comparison with Prescription Drugs
RegeneRx Biopharmaceuticals recently announced a new study comparing RGN-259 with currently approved prescription products for dry eye syndrome (DES) demonstrated that after 10 days of treatment, RGN-259 performed equal to or better than cyclosporine A, lifitegrast and diquafosol. The study parameters measured were tear production, corneal smoothness and decreased fluorescein staining, as well as corneal epithelial detachment, conjunctival goblet cells, mucin production and expression of inflammatory factors. RGN-259 was equal to or better than the other approved products in each case, according to a company news release. Read more.

Optometric Physician™ Editorial Board

Chief Medical Editor
Arthur B. Epstein, OD, FAAO

Journal Reviews
Shannon Steinhäuser, OD, FAAO

Contributing Editors
• Katherine M. Mastrota, MS, OD, FAAO
• Barry A. Weissman, OD, PhD, FAAO (Dip CL)

Editorial Board
• William Jones, OD, FAAO
• Alan G. Kabat, OD, FAAO
• Bruce Onofrey, RPh, OD, FAAO
• John Schachet, OD, FIOS
• Joseph Shovlin, OD, FAAO



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