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EW SHOW DAILY 64 Meeting Reporter by Ellen Stodola EyeWorld Senior Staff Writer at the end of 2018, Ms. McCann said. EW Editors' note: Ms. McCann has no financial interests related to her comments. O n Thursday evening, the ASCRS•ASOA Government Relations team held a brief meeting for industry on "What the Ophthalmic Industry Needs to Know About Coming Medicare Reforms." Nancey McCann, ASCRS direc- tor of government relations, Fairfax, Virginia, highlighted some of the key issues impacting ophthalmol- ogy, including implementation of MACRA (quality payment program), the Misvalued Code Initiative (min- imizing drastic cuts to retina and glaucoma codes), the 21st Century Cures Initiative, and Cleaning and Sterilization Guidelines. Secondary issues relating to ophthalmology include repealing the Independent Payment Advisory Board, private contracting/patient shared respon- sibility, drug compounding, and pro- posed health insurer mergers. A common theme over the past 4–5 years, she said, has been biparti- san effort aimed at moving Medicare payment into a system based on outcomes, quality, and efficiencies. There is also a goal of tying 30% of traditional or fee-for-service Medi- care payments to "quality or value" through alternative payment models (ACOs or bundled payment models) by the end of 2016 (which has al- ready been accomplished) and 50% of payments to these models by the end of 2018. Ms. McCann spoke about the newly proposed quality payment program, which includes the Merit- Based Incentive Payment System (MIPS) and advanced alternative payment models (APMs). MIPS consolidates the current quality re- porting programs (PQRS, VBPM, and Meaningful Use) and adds clinical practice improvement activities into this new program. MIPS will begin in 2019, based on 2017 perfor- mance. She discussed improvements with MACRA compared to prior law. "We now have modest but positive updates for 5 years," she said. The quality reporting programs are also consolidated with more flexibility, potential for significant bonuses, and lower maximum penalties. There's financial support for small practices as well, Ms. McCann said. With the MIPS program, physi- cians will receive a composite perfor- mance score (from 0 to 100) based on their performance in 4 categories: quality (making up 50% of the com- posite score), cost (10%), advancing care information, previously called Meaningful Use (25%), and clinical practice improvement activities (15%). This composite score will then be compared to a performance threshold. The most important point is that existing penalties associated with the current programs do end Medicare update for industry BRIEF SUMMARY OF PRESCRIBING INFORMATION This Brief Summary does not include all the information needed to prescribe Lotemax Gel safely and effectively. See full prescribing information for Lotemax Gel. Lotemax (loteprednol etabonate ophthalmic gel) 0.5% Rx only Initial Rx Approval: 1998 INDICATIONS AND USAGE LOTEMAX is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery. DOSAGE AND ADMINISTRATION Invert closed bottle and shake once to fill tip before instilling drops. Apply one to two drops of LOTEMAX into the conjunctival sac of the affected eye four times daily beginning the day after surgery and continuing throughout the first 2 weeks of the post-operative period. CONTRAINDICATIONS LOTEMAX, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. WARNINGS AND PRECAUTIONS Intraocular Pressure (IOP) Increase Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. If this product is used for 10 days or longer, intraocular pressure should be monitored. Cataracts Use of corticosteroids may result in posterior subcapsular cataract formation. Delayed Healing The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. Bacterial Infections Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection. Viral Infections Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Fungal Infections Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal cultures should be taken when appropriate. Contact Lens Wear Patients should not wear contact lenses during their course of therapy with LOTEMAX. ADVERSE REACTIONS Adverse reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with infrequent optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, delayed wound healing and secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera. The most common adverse drug reactions reported were anterior chamber inflammation (5%), eye pain (2%), and foreign body sensation (2%). USE IN SPECIFIC POPULATIONS Pregnancy Teratogenic Effects: Pregnancy Category C. Loteprednol etabonate has been shown to be embryotoxic (delayed ossification) and teratogenic (increased incidence of meningocele, abnormal left common carotid artery, and limb flexures) when administered orally to rabbits during organogenesis at a dose of 3 mg/kg/day (35 times the maximum daily clinical dose), a dose which caused no maternal toxicity. The no-observed-effect-level (NOEL) for these effects was 0.5 mg/kg/day (6 times the maximum daily clinical dose). Oral treatment of rats during organogenesis resulted in teratogenicity (absent innominate artery at ≥5 mg/kg/day doses, and cleft palate and umbilical hernia at ≥50 mg/kg/day) and embryotoxicity (increased post-implantation losses at 100 mg/kg/day and decreased fetal body weight and skeletal ossification with ≥50 mg/kg/day). Treatment of rats with 0.5 mg/kg/day (6 times the maximum clinical dose) during organogenesis did not result in any reproductive toxicity. Loteprednol etabonate was maternally toxic (significantly reduced body weight gain during treatment) when administered to pregnant rats during organogenesis at doses of ≥5 mg/kg/day. Oral exposure of female rats to 50 mg/kg/day of loteprednol etabonate from the start of the fetal period through the end of lactation, a maternally toxic treatment regimen (significantly decreased body weight gain), gave rise to decreased growth and survival, and retarded development in the offspring during lactation; the NOEL for these effects was 5 mg/kg/day. Loteprednol etabonate had no effect on the duration of gestation or parturition when administered orally to pregnant rats at doses up to 50 mg/kg/day during the fetal period. There are no adequate and well controlled studies in pregnant women. LOTEMAX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemic steroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when LOTEMAX is administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger patients. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment Of Fertility Long-term animal studies have not been conducted to evaluate the carcinogenic potential of loteprednol etabonate. Loteprednol etabonate was not genotoxic in vitro in the Ames test, the mouse lymphoma tk assay, or in a chromosome aberration test in human lymphocytes, or in vivo in the single dose mouse micronucleus assay. Treatment of male and female rats with up to 50 mg/kg/day and 25 mg/kg/day of loteprednol etabonate, respectively, (600 and 300 times the maximum clinical dose, respectively) prior to and during mating did not impair fertility in either gender. PATIENT COUNSELING INFORMATION Administration Invert closed bottle and shake once to fill tip before instilling drops. Risk of Contamination Patients should be advised not to allow the dropper tip to touch any surface, as this may contaminate the gel. Contact Lens Wear Patients should be advised not to wear contact lenses when using LOTEMAX. Risk of Secondary Infection If pain develops, redness, itching or inflammation becomes aggravated, the patient should be advised to consult a physician. Bausch & Lomb Incorporated Tampa, Florida 33637 USA US Patent No. 5,800,807 ©Bausch & Lomb Incorporated ®/™ are trademarks of Bausch & Lomb Incorporated or its affiliates. US/LGX/15/0042 Based on 9269100-9269200 Revised: 9/2012 Saturday, May 7, 2016

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