Special Section to Today Vol. 4, No. 1

MAKING THE LEAP TO PRIVATE EQUITY

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0321RTBM_Cover.indd 1 2/26/21 10:33 AM EYLEA IMPROVED AND SUSTAINED YOUR PATIENTS VISION GAINS THROUGH 52 AND 100 WEEKS IN DME1-3 EYLEA 2 MG EYLEA 2 MG CONTROL WITH DME EVERY 4 WEEKS§ EVERY 8 WEEKS|| VISTA (n=154) (n=151) (n=154) MEAN CHANGE IN BCVA † +12.5, +11.5 +10.7, +11.1 +0.2, +0.9 (52 WEEKS,* 100 WEEKS ) LETTERS LETTERS LETTERS PROPORTION GAINED ARE READY ≥15 LETTERS 41.6%, 38.3% 31.1%, 33.1% 7.8%, 13.0% (52 WEEKS,‡ 100 WEEKS†) VIVID (n=136) (n=135) (n=132) FOR A CHANGE MEAN CHANGE IN BCVA † +10.5, +11.4 +10.7, +9.4 +1.2, +0.7 (52 WEEKS,* 100 WEEKS ) LETTERS LETTERS LETTERS PROPORTION GAINED The power of EYLEA improved and sustained outcomes ≥15 LETTERS 32.4%, 38.2% 33.3%, 31.1% 9.1%, 12.1% (52 WEEKS,‡ 100 WEEKS†) in the largest phase 3 anti-VEGF clinical trials completed VISTA and VIVID study designs: Two randomized, multicenter, double-masked, controlled studies in which patients with DME to date in DME (N=862), with improved at (N=862; age range: 23-87 years, with a mean of 63 years) were randomized and received 1) EYLEA 2 mg administered every 8 weeks following 5 initial monthly doses; 2) EYLEA 2 mg administered every 4 weeks; or 3) macular laser photocoagulation (control) at 52 and 100 weeks.1 baseline and then as needed. Protocol-speci ed visits occurred every 28 (±7) days. In both studies, the primary e cacy endpoint was the mean change from baseline in BCVA at week 52, as measured by ETDRS letter score. E cacy of both EYLEA groups was statistically superior vs control at 52 and 100 weeks (P<0.01). *Primary endpoint. † Prespeci ed exploratory endpoint. IMPORTANT SAFETY INFORMATION AND INDICATIONS ‡ Secondary endpoint. § Last observation carried forward; full analysis set. CONTRAINDICATIONS || Following 5 initial monthly doses. The results of exploratory endpoints require cautious interpretation and could represent chance ndings, as a multiplicity adjustment • EYLEA is contraindicated in patients with ocular or periocular infections, active intraocular in ammation, or has not been applied. known hypersensitivity to a ibercept or to any of the excipients in EYLEA. anti-VEGF = anti–vascular endothelial growth factor; BCVA = best-corrected visual acuity; DME = Diabetic ; ETDRS = Early Treatment Study. WARNINGS AND PRECAUTIONS • Intravitreal injections, including those with EYLEA, have been associated with and retinal See more at HCP.EYLEA.US detachments. Proper aseptic injection technique must always be used when administering EYLEA. Patients should be instructed to report any symptoms suggestive of endophthalmitis or without ADVERSE REACTIONS delay and should be managed appropriately. Intraocular in ammation has been reported with the use of EYLEA. • Serious adverse reactions related to the injection procedure have occurred in <0.1% of intravitreal • Acute increases in intraocular pressure have been seen with 60 minutes of intravitreal injection, including with injections with EYLEA including endophthalmitis and retinal detachment. EYLEA. Sustained increases in intraocular pressure have also been reported after repeated intravitreal dosing • The most common adverse reactions (≥5%) reported in patients receiving EYLEA were conjunctival with VEGF inhibitors. Intraocular pressure and the perfusion of the optic nerve head should be monitored and hemorrhage, pain, , vitreous detachment, vitreous  oaters, and intraocular pressure increased. managed appropriately. • There is a potential risk of arterial thromboembolic events (ATEs) following intravitreal use of VEGF inhibitors, INDICATIONS including EYLEA. ATEs are de ned as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including EYLEA® (a ibercept) Injection 2 mg (0.05 mL) is indicated for the treatment of patients with Neovascular deaths of unknown cause). The incidence of reported thromboembolic events in wet AMD studies during the (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), rst year was 1.8% (32 out of 1824) in the combined group of patients treated with EYLEA compared with 1.5% Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). (9 out of 595) in patients treated with ranibizumab; through 96 weeks, the incidence was 3.3% (60 out of 1824) in the EYLEA group compared with 3.2% (19 out of 595) in the ranibizumab group. The incidence in the DME studies from baseline to week 52 was 3.3% (19 out of 578) in the combined group of patients treated with EYLEA compared with 2.8% (8 out of 287) in the control group; from baseline to week 100, the incidence was 6.4% (37 References: 1. EYLEA® (a ibercept) Injection full U.S. Prescribing Information. Regeneron out of 578) in the combined group of patients treated with EYLEA compared with 4.2% (12 out of 287) in the Pharmaceuticals, Inc. August 2019. 2. Korobelnik JF, Do DV, Schmidt-Erfurth U, et al. Intravitreal control group. There were no reported thromboembolic events in the patients treated with EYLEA in the rst six a ibercept for diabetic macular edema. Ophthalmology. 2014;121(11):2247-2254. doi:10.1016/j. ophtha.2014.05.006 3. Brown DM, Schmidt-Erfurth U, Do DV, et al. Intravitreal a ibercept for months of the RVO studies. diabetic macular edema: 100-week results from the VISTA and VIVID studies. Ophthalmology. 2015;122(10):2044-2052. doi:10.1016/j.ophtha. 2015.06.017 EYLEA is a registered trademark of Regeneron Pharmaceuticals, Inc.

© 2020, Regeneron Pharmaceuticals, Inc. All rights reserved. 08/2020 777 Old Saw Mill River Road, Tarrytown, NY 10591 Please see Brief Summary of Prescribing Information on the following page. EYL.20.07.0057

Untitled-4EYL.20.07.0057_REEYR21308_Retina 2 Today_DR_Journal_Ad_February_FINAL.indd 1-2 2/26/21 11:50 AM 1/11/21 2:01 PM EYLEA IMPROVED AND SUSTAINED YOUR PATIENTS VISION GAINS THROUGH 52 AND 100 WEEKS IN DME1-3 EYLEA 2 MG EYLEA 2 MG CONTROL WITH DME EVERY 4 WEEKS§ EVERY 8 WEEKS|| VISTA (n=154) (n=151) (n=154) MEAN CHANGE IN BCVA † +12.5, +11.5 +10.7, +11.1 +0.2, +0.9 (52 WEEKS,* 100 WEEKS ) LETTERS LETTERS LETTERS PROPORTION GAINED ARE READY ≥15 LETTERS 41.6%, 38.3% 31.1%, 33.1% 7.8%, 13.0% (52 WEEKS,‡ 100 WEEKS†) VIVID (n=136) (n=135) (n=132) FOR A CHANGE MEAN CHANGE IN BCVA † +10.5, +11.4 +10.7, +9.4 +1.2, +0.7 (52 WEEKS,* 100 WEEKS ) LETTERS LETTERS LETTERS PROPORTION GAINED The power of EYLEA improved and sustained outcomes ≥15 LETTERS 32.4%, 38.2% 33.3%, 31.1% 9.1%, 12.1% (52 WEEKS,‡ 100 WEEKS†) in the largest phase 3 anti-VEGF clinical trials completed VISTA and VIVID study designs: Two randomized, multicenter, double-masked, controlled studies in which patients with DME to date in DME (N=862), with improved visual acuity at (N=862; age range: 23-87 years, with a mean of 63 years) were randomized and received 1) EYLEA 2 mg administered every 8 weeks following 5 initial monthly doses; 2) EYLEA 2 mg administered every 4 weeks; or 3) macular laser photocoagulation (control) at 52 and 100 weeks.1 baseline and then as needed. Protocol-speci ed visits occurred every 28 (±7) days. In both studies, the primary e cacy endpoint was the mean change from baseline in BCVA at week 52, as measured by ETDRS letter score. E cacy of both EYLEA groups was statistically superior vs control at 52 and 100 weeks (P<0.01). *Primary endpoint. † Prespeci ed exploratory endpoint. IMPORTANT SAFETY INFORMATION AND INDICATIONS ‡ Secondary endpoint. § Last observation carried forward; full analysis set. CONTRAINDICATIONS || Following 5 initial monthly doses. The results of exploratory endpoints require cautious interpretation and could represent chance ndings, as a multiplicity adjustment • EYLEA is contraindicated in patients with ocular or periocular infections, active intraocular in ammation, or has not been applied. known hypersensitivity to a ibercept or to any of the excipients in EYLEA. anti-VEGF = anti–vascular endothelial growth factor; BCVA = best-corrected visual acuity; DME = Diabetic Macular Edema; ETDRS = Early Treatment Diabetic Retinopathy Study. WARNINGS AND PRECAUTIONS • Intravitreal injections, including those with EYLEA, have been associated with endophthalmitis and retinal See more at HCP.EYLEA.US detachments. Proper aseptic injection technique must always be used when administering EYLEA. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without ADVERSE REACTIONS delay and should be managed appropriately. Intraocular in ammation has been reported with the use of EYLEA. • Serious adverse reactions related to the injection procedure have occurred in <0.1% of intravitreal • Acute increases in intraocular pressure have been seen with 60 minutes of intravitreal injection, including with injections with EYLEA including endophthalmitis and retinal detachment. EYLEA. Sustained increases in intraocular pressure have also been reported after repeated intravitreal dosing • The most common adverse reactions (≥5%) reported in patients receiving EYLEA were conjunctival with VEGF inhibitors. Intraocular pressure and the perfusion of the optic nerve head should be monitored and hemorrhage, eye pain, cataract, vitreous detachment, vitreous  oaters, and intraocular pressure increased. managed appropriately. • There is a potential risk of arterial thromboembolic events (ATEs) following intravitreal use of VEGF inhibitors, INDICATIONS including EYLEA. ATEs are de ned as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including EYLEA® (a ibercept) Injection 2 mg (0.05 mL) is indicated for the treatment of patients with Neovascular deaths of unknown cause). The incidence of reported thromboembolic events in wet AMD studies during the (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), rst year was 1.8% (32 out of 1824) in the combined group of patients treated with EYLEA compared with 1.5% Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). (9 out of 595) in patients treated with ranibizumab; through 96 weeks, the incidence was 3.3% (60 out of 1824) in the EYLEA group compared with 3.2% (19 out of 595) in the ranibizumab group. The incidence in the DME studies from baseline to week 52 was 3.3% (19 out of 578) in the combined group of patients treated with EYLEA compared with 2.8% (8 out of 287) in the control group; from baseline to week 100, the incidence was 6.4% (37 References: 1. EYLEA® (a ibercept) Injection full U.S. Prescribing Information. Regeneron out of 578) in the combined group of patients treated with EYLEA compared with 4.2% (12 out of 287) in the Pharmaceuticals, Inc. August 2019. 2. Korobelnik JF, Do DV, Schmidt-Erfurth U, et al. Intravitreal control group. There were no reported thromboembolic events in the patients treated with EYLEA in the rst six a ibercept for diabetic macular edema. Ophthalmology. 2014;121(11):2247-2254. doi:10.1016/j. ophtha.2014.05.006 3. Brown DM, Schmidt-Erfurth U, Do DV, et al. Intravitreal a ibercept for months of the RVO studies. diabetic macular edema: 100-week results from the VISTA and VIVID studies. Ophthalmology. 2015;122(10):2044-2052. doi:10.1016/j.ophtha. 2015.06.017 EYLEA is a registered trademark of Regeneron Pharmaceuticals, Inc.

© 2020, Regeneron Pharmaceuticals, Inc. All rights reserved. 08/2020 777 Old Saw Mill River Road, Tarrytown, NY 10591 Please see Brief Summary of Prescribing Information on the following page. EYL.20.07.0057

EYL.20.07.0057_REEYR21308_Retina Today_DR_Journal_Ad_February_FINAL.indd 1-2 Untitled-4 3 2/26/211/11/21 11:50 2:01 PMAM BRIEF SUMMARY—Please see the EYLEA Table 2: Most Common Adverse Reactions (≥1%) in RVO Studies full Prescribing Information available CRVO BRVO on HCP.EYLEA.US for additional EYLEA Control EYLEA Control Adverse Reactions (N=218) (N=142) (N=91) (N=92) product information. Eye pain 13% 5% 4% 5% Conjunctival hemorrhage 12% 11% 20% 4% Intraocular pressure increased 8% 6% 2% 0% 1 INDICATIONS AND USAGE Corneal epithelium defect 5% 4% 2% 0% EYLEA is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of: Vitreous 5% 1% 1% 0% Neovascular (Wet) Age-Related Macular Degeneration (AMD); Macular Edema Following Retinal Vein Occlusion (RVO); Diabetic Ocular hyperemia 5% 3% 2% 2% Macular Edema (DME); Diabetic Retinopathy (DR). Foreign body sensation in 3% 5% 3% 0% 4 CONTRAINDICATIONS Vitreous detachment 3% 4% 2% 0% 4.1 Ocular or Periocular Infections Lacrimation increased 3% 4% 3% 0% EYLEA is contraindicated in patients with ocular or periocular infections. Injection site pain 3% 1% 1% 0% 4.2 Active Intraocular Inflammation Vision blurred 1% <1% 1% 1% EYLEA is contraindicated in patients with active intraocular inflammation. Intraocular inflammation 1% 1% 0% 0% 4.3 Hypersensitivity Cataract <1% 1% 5% 0% EYLEA is contraindicated in patients with known hypersensitivity to aflibercept or any of the excipients in EYLEA. Hypersensitivity edema <1% 1% 1% 0% reactions may manifest as rash, pruritus, urticaria, severe anaphylactic/anaphylactoid reactions, or severe intraocular inflammation. 5 WARNINGS AND PRECAUTIONS Less common adverse reactions reported in <1% of the patients treated with EYLEA in the CRVO studies were corneal edema, retinal 5.1 Endophthalmitis and Retinal Detachments. tear, hypersensitivity, and endophthalmitis. Intravitreal injections, including those with EYLEA, have been associated with endophthalmitis and retinal detachments [see Adverse Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR). The data described below reflect exposure to EYLEA in 578 patients Reactions (6.1)]. Proper aseptic injection technique must always be used when administering EYLEA. Patients should be instructed with DME treated with the 2-mg dose in 2 double-masked, controlled clinical studies (VIVID and VISTA) from baseline to week 52 and to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately from baseline to week 100. [see Patient Counseling Information (17)]. Table 3: Most Common Adverse Reactions (≥1%) in DME Studies 5.2 Increase in Intraocular Pressure. Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including with EYLEA [see Adverse Baseline to Week 52 Baseline to Week 100 Reactions (6.1)]. Sustained increases in intraocular pressure have also been reported after repeated intravitreal dosing with vascular EYLEA Control EYLEA Control endothelial growth factor (VEGF) inhibitors. Intraocular pressure and the perfusion of the optic nerve head should be monitored and Adverse Reactions (N=578) (N=287) (N=578) (N=287) managed appropriately. Conjunctival hemorrhage 28% 17% 31% 21% 5.3 Thromboembolic Events. There is a potential risk of arterial thromboembolic events (ATEs) following intravitreal use of VEGF inhibitors, including EYLEA. ATEs Eye pain 9% 6% 11% 9% are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). The incidence of Cataract 8% 9% 19% 17% reported thromboembolic events in wet AMD studies during the first year was 1.8% (32 out of 1824) in the combined group of patients Vitreous floaters 6% 3% 8% 6% treated with EYLEA compared with 1.5% (9 out of 595) in patients treated with ranibizumab; through 96 weeks, the incidence was Corneal epithelium defect 5% 3% 7% 5% 3.3% (60 out of 1824) in the EYLEA group compared with 3.2% (19 out of 595) in the ranibizumab group. The incidence in the DME Intraocular pressure increased 5% 3% 9% 5% studies from baseline to week 52 was 3.3% (19 out of 578) in the combined group of patients treated with EYLEA compared with 2.8% (8 out of 287) in the control group; from baseline to week 100, the incidence was 6.4% (37 out of 578) in the combined group of Ocular hyperemia 5% 6% 5% 6% patients treated with EYLEA compared with 4.2% (12 out of 287) in the control group. There were no reported thromboembolic events Vitreous detachment 3% 3% 8% 6% in the patients treated with EYLEA in the first six months of the RVO studies. Foreign body sensation in eyes 3% 3% 3% 3% 6 ADVERSE REACTIONS Lacrimation increased 3% 2% 4% 2% The following potentially serious adverse reactions are described elsewhere in the labeling: Vision blurred 2% 2% 3% 4% • Hypersensitivity [see Contraindications (4.3)] Intraocular inflammation 2% <1% 3% 1% • Endophthalmitis and retinal detachments [see Warnings and Precautions (5.1)] • Increase in intraocular pressure [see Warnings and Precautions (5.2)] Injection site pain 2% <1% 2% <1% Eyelid edema <1% 1% 2% 1% • Thromboembolic events [see Warnings and Precautions (5.3)] 6.1 Clinical Trials Experience. Less common adverse reactions reported in <1% of the patients treated with EYLEA were hypersensitivity, retinal detachment, retinal Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug tear, corneal edema, and injection site hemorrhage. cannot be directly compared to rates in other clinical trials of the same or another drug and may not reflect the rates observed Safety data observed in 269 patients with nonproliferative diabetic retinopathy (NPDR) through week 52 in the PANORAMA trial were in practice. consistent with those seen in the phase 3 VIVID and VISTA trials (see Table 3 above). A total of 2980 patients treated with EYLEA constituted the safety population in eight phase 3 studies. Among those, 2379 patients 6.2 Immunogenicity. were treated with the recommended dose of 2 mg. Serious adverse reactions related to the injection procedure have occurred in <0.1% As with all therapeutic proteins, there is a potential for an immune response in patients treated with EYLEA. The immunogenicity of intravitreal injections with EYLEA including endophthalmitis and retinal detachment. The most common adverse reactions (≥5%) of EYLEA was evaluated in serum samples. The immunogenicity data reflect the percentage of patients whose test results were reported in patients receiving EYLEA were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and considered positive for antibodies to EYLEA in immunoassays. The detection of an immune response is highly dependent on the intraocular pressure increased. sensitivity and specificity of the assays used, sample handling, timing of sample collection, concomitant medications, and underlying Neovascular (Wet) Age-Related Macular Degeneration (AMD). The data described below reflect exposure to EYLEA in 1824 patients disease. For these reasons, comparison of the incidence of antibodies to EYLEA with the incidence of antibodies to other products may with wet AMD, including 1223 patients treated with the 2-mg dose, in 2 double-masked, controlled clinical studies (VIEW1 and VIEW2) be misleading. for 24 months (with active control in year 1). In the wet AMD, RVO, and DME studies, the pre-treatment incidence of immunoreactivity to EYLEA was approximately 1% to 3% across Safety data observed in the EYLEA group in a 52-week, double-masked, Phase 2 study were consistent with these results. treatment groups. After dosing with EYLEA for 24-100 weeks, antibodies to EYLEA were detected in a similar percentage range of patients. There were no differences in efficacy or safety between patients with or without immunoreactivity. Table 1: Most Common Adverse Reactions (≥1%) in Wet AMD Studies Baseline to Week 52 Baseline to Week 96 8 USE IN SPECIFIC POPULATIONS. 8.1 Pregnancy Active Control Control Risk Summary EYLEA (ranibizumab) EYLEA (ranibizumab) Adequate and well-controlled studies with EYLEA have not been conducted in pregnant women. Aflibercept produced adverse Adverse Reactions (N=1824) (N=595) (N=1824) (N=595) embryofetal effects in rabbits, including external, visceral, and skeletal malformations. A fetal No Observed Adverse Effect Level Conjunctival hemorrhage 25% 28% 27% 30% (NOAEL) was not identified. At the lowest dose shown to produce adverse embryofetal effects, systemic exposures (based on AUC for Eye pain 9% 9% 10% 10% free aflibercept) were approximately 6 times higher than AUC values observed in humans after a single intravitreal treatment at the Cataract 7% 7% 13% 10% recommended clinical dose [see Animal Data]. Animal reproduction studies are not always predictive of human response, and it is not known whether EYLEA can cause fetal harm Vitreous detachment 6% 6% 8% 8% when administered to a pregnant woman. Based on the anti-VEGF mechanism of action for aflibercept, treatment with EYLEA may Vitreous floaters 6% 7% 8% 10% pose a risk to human embryofetal development. EYLEA should be used during pregnancy only if the potential benefit justifies the Intraocular pressure increased 5% 7% 7% 11% potential risk to the fetus. Ocular hyperemia 4% 8% 5% 10% All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects Corneal epithelium defect 4% 5% 5% 6% and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Detachment of the retinal pigment epithelium 3% 3% 5% 5% Data Injection site pain 3% 3% 3% 4% Animal Data Foreign body sensation in eyes 3% 4% 4% 4% In two embryofetal development studies, aflibercept produced adverse embryofetal effects when administered every three days Lacrimation increased 3% 1% 4% 2% during organogenesis to pregnant rabbits at intravenous doses ≥3 mg per kg, or every six days during organogenesis at subcutaneous Vision blurred 2% 2% 4% 3% doses ≥0.1 mg per kg. Intraocular inflammation 2% 3% 3% 4% Adverse embryofetal effects included increased incidences of postimplantation loss and fetal malformations, including anasarca, umbilical hernia, diaphragmatic hernia, gastroschisis, cleft palate, ectrodactyly, intestinal atresia, spina bifida, encephalomeningocele, Retinal pigment epithelium tear 2% 1% 2% 2% heart and major vessel defects, and skeletal malformations (fused vertebrae, sternebrae, and ribs; supernumerary vertebral arches Injection site hemorrhage 1% 2% 2% 2% and ribs; and incomplete ossification). The maternal No Observed Adverse Effect Level (NOAEL) in these studies was 3 mg per kg. Eyelid edema 1% 2% 2% 3% Aflibercept produced fetal malformations at all doses assessed in rabbits and the fetal NOAEL was not identified. At the lowest Corneal edema 1% 1% 1% 1% dose shown to produce adverse embryofetal effects in rabbits (0.1 mg per kg), systemic exposure (AUC) of free aflibercept was Retinal detachment <1% <1% 1% 1% approximately 6 times higher than systemic exposure (AUC) observed in humans after a single intravitreal dose of 2 mg. 8.2 Lactation Less common serious adverse reactions reported in <1% of the patients treated with EYLEA were hypersensitivity, retinal tear, and Risk Summary endophthalmitis. There is no information regarding the presence of aflibercept in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production/excretion. Because many drugs are excreted in human milk, and because the potential for Macular Edema Following Retinal Vein Occlusion (RVO). The data described below reflect 6 months exposure to EYLEA with a absorption and harm to infant growth and development exists, EYLEA is not recommended during breastfeeding. monthly 2 mg dose in 218 patients following CRVO in 2 clinical studies (COPERNICUS and GALILEO) and 91 patients following BRVO in The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for EYLEA and any one clinical study (VIBRANT). potential adverse effects on the breastfed child from EYLEA. 8.3 Females and Males of Reproductive Potential Contraception Females of reproductive potential are advised to use effective contraception prior to the initial dose, during treatment, and for at least 3 months after the last intravitreal injection of EYLEA. Infertility There are no data regarding the effects of EYLEA on human fertility. Aflibercept adversely affected female and male reproductive systems in cynomolgus monkeys when administered by intravenous injection at a dose approximately 1500 times higher than the systemic level observed humans with an intravitreal dose of 2 mg. A No Observed Adverse Effect Level (NOAEL) was not identified. These findings were reversible within 20 weeks after cessation of treatment. 8.4 Pediatric Use. The safety and effectiveness of EYLEA in pediatric patients have not been established. 8.5 Geriatric Use. In the clinical studies, approximately 76% (2049/2701) of patients randomized to treatment with EYLEA were ≥65 years of age and Manufactured by: approximately 46% (1250/2701) were ≥75 years of age. No significant differences in efficacy or safety were seen with increasing age Regeneron Pharmaceuticals, Inc. Issue Date: 08/2019 in these studies. 777 Old Saw Mill River Road Initial U.S. Approval: 2011 Tarrytown, NY 10591 17 PATIENT COUNSELING INFORMATION Based on the August 2019 In the days following EYLEA administration, patients are at risk of developing endophthalmitis or retinal detachment. If the EYLEA is a registered trademark of Regeneron EYLEA® (aflibercept) Injection full eye becomes red, sensitive to light, painful, or develops a change in vision, advise patients to seek immediate care from an Pharmaceuticals, Inc. Prescribing Information. ophthalmologist [see Warnings and Precautions (5.1)]. © 2019, Regeneron Pharmaceuticals, Inc. Patients may experience temporary visual disturbances after an intravitreal injection with EYLEA and the associated eye examinations All rights reserved. EYL.19.07.0306 [see Adverse Reactions (6)]. Advise patients not to drive or use machinery until visual function has recovered sufficiently.

EYL.20.07.0057_REEYR21308_Retina Today_DR_Journal_Ad_February_FINAL.indd 3 1/11/21 2:01 PM Untitled-4 4 2/26/21 11:50 AM TIME TO GET OUT TABLE OF OR GROW CONTENTS

Welcome to the first issue of Retina Today 6 When Multiple Procedures Are Business Matters for 2021. Hopefully the trials of 2020 are behind us, although face masks, face Performed in the Same Session shields, and disinfecting wipes may be permanent By Joy Woodke, COE, OCS, OCSR line items in our budgets now. Unfortunately, 2020 put a lot of emotional and financial strain on practice owners. It had a lot of us asking, “Is it time to get out?” 8 Making the Leap to Private Equity Many, like this month’s featured author, decided it was time to hand over their practice management responsibili- By David F. Williams, MD, MBA ties to a private equity (PE) firm and shift their focus back to patient care. In his article, “Making the Leap to Private Equity,” David F. Williams, MD, MBA, details the pros and cons of the deci- 11 Practice Growth Considerations sion to sell to PE, and why merging with a firm consisting only of retina practices made all the difference for him and his partners. in Challenging Times It’s a big decision, and one many practice owners are still leery By Marie Czenko about. As PE investors continue to consolidate ophthalmology practices, now is a good time to revisit the subject and see how the landscape has changed, and why it may—or may not—be the right 14 How to Put Low Interest move for your practice. For those of you who aren’t interested in PE, this issue also Rates to Work For You includes articles geared toward growing your practice and improv- ing your revenue streams. You can learn about a four-step process By David B. Mandell, JD, MBA, for embracing growth opportunities safely, how to capitalize on and Jason M. O’Dell, MS, CWM today’s historically low interest rates, and how to improve your reimbursements for same-session procedures. Regardless of whether you are looking for an escape route in 2021 or are looking for ways to make this your practice’s best year yet, we’ve got you covered. ALAN RUBY, MD SECTION EDITOR

VOL. 4, NO. 1 | RETINA TODAY BUSINESS MATTERS 5

0321RTBM_Editorial.indd 5 2/26/21 10:33 AM CODING ADVISOR CODINGADVISOR A Collaboration Between Retina Today and WHEN MULTIPLE PROCEDURES ARE PERFORMED IN THE SAME SESSION A checklist of 10 steps for correct coding.

BY JOY WOODKE, COE, OCS, OCSR

any retina surgical cases involve multiple proce- Step No. 2: Confirm that prior authorization was obtained dures. In these cases, it is crucial to identify the when required prior to surgery. correct coding in order to reduce denials and maxi- For insurance payers that require prior authorization (PA), mize reimbursement. Use the 10 steps outlined in request and confirm that the approval is on file. Additionally, this article to ensure accuracy. review that the CPT and ICD-10-CM code or codes, place of M service, and surgeon are accurate. If the PA was not obtained Step No. 1: Identify all CPT codes performed, and read the or the CPT codes authorized are not correct, a retroactive full CPT descriptor. request should be initiated promptly. From the operative report, confirm each procedure per- formed, select the appropriate CPT code, and review the full Step No. 3: Meet the specific payer’s preoperative CPT code descriptor. Many retina procedures use the same documentation guidelines. techniques and may appear similar for coding purposes. The Medicare Administrative Contractors (MACs) provide local CPT code descriptor may provide additional details, how- coverage determinations (LCDs) and local coverage articles ever, including the reason for the surgery. (LCAs) for specific services including testing services, injections, For example, a vitrectomy is frequently per- and surgeries. Additionally, CMS provides national coverage formed during a retina surgical case, but the diagnosis will determinations (NCDs) that apply to all jurisdictions. Current confirm the correct CPT code based on the definition. NCDs relevant to retina cover procedures including vitrec- Coding for a vitrectomy for endophthalmitis (CPT code tomy and photodynamic therapy (PDT) laser. The policy for 67036, vitrectomy, mechanical, pars plana approach) is PDT laser includes specific documentation and testing service much different from coding for a vitrectomy performed requirements to establish medical necessity. A checklist of during a retinal detachment repair (CPT code 67108, these requirements can be found at aao.org/retinapm. repair of retinal detachment; with vitrectomy, any method Review all current LCD and NCD policies for all multiple including, when performed, air or gas tamponade, focal procedures performed, and confirm that documentation, endolaser photocoagulation, cryotherapy drainage of sub- frequency limitations, required testing services, and support- retinal fluid, scleral buckling, and/or removal of lens by ing ICD-10-CM codes are met per policy. These policies are same technique). available at aao.org/lcds. Explore more on CPT code selection based on the reason Commercial, Medicaid, and other payers may have unique for surgery in the previous Retina Today article “Properly policies and documentation requirements. If they have been Coding Retina Surgeries.”1 published, they may be available on the payer website or

6 RETINA TODAY BUSINESS MATTERS | VOL. 4, NO. 1

0321rtbm_Coding_Feature_Williams.indd 6 2/26/21 11:47 AM CODING ADVISOR

portal or in provider manuals. Confirm each payer’s relevant TABLE 1. SITE OF SERVICE DIFFERENTIAL guidelines for services provided in the retina practice. CPT Code Description Nonfacility Facility Step No. 4: Identify the global period of each CPT code and 67028 Intravitreal injection 121.73 98.42 whether procedures were performed during a global period. 67228 Panretinal photocoagulation laser 364.38 323.58 First, confirm the global period of each CPT code selected 67036 Pars plana vitrectomy 955.71 955.71 to identify the procedures as major (90-day global period) or Source: 2021 Medicare fee schedule, Chicago minor (0 or 10-day global period). This would be relevant if an examination was performed the same day as the surgery. TABLE 2. NCCI BUNDLES FOR CPT CODES 66825 AND 66682 Also consider whether modifiers -25 (significant separately, identifiable evaluation and management code the same day Column 1 Column 2 Date of Bundle Date of Deletion Indicator as minor surgery) or -57 (decision to perform major surgery) 66825 66682 2002/04/01 * 1 would be appropriate for this case. Source: NCCI version 27.0 Next, determine if the surgery was performed during the postoperative period of another surgery; if so, additional sur- Coding Initiative (NCCI) edits for all codes. Check each code in gical modifiers will be required. every combination. For example, is the first code bundled with the second and/or third? Is the second bundled with the first Step No. 5: List the CPT codes in order from highest to or third? lowest relative value unit and/or allowable for that payer. If codes are bundled and it is not appropriate to unbundle, When multiple procedures are performed during the same eliminate the lowest paying code or codes. session, standard payment adjustment rules apply. This is NCCI indicators can be defined as mutually exclusive or defined as the multiple procedure indicator of “2” per CPT comprehensive: code, and it results in payment of 100% of the allowable for • Mutually exclusive codes can never be unbundled and the first procedure and 50% for the subsequent procedures, have an indicator of 0. regardless of whether performed in the same or both eyes. • Comprehensive codes with an indicator of 1 may be Because of the multiple procedure reduction, rank the paid separately under limited circumstances and must eligible CPT codes from highest to lowest based on their rela- meet the definition of modifier -59 or per specific LCDs. tive value units (RVUs) or the payer’s fee schedule. This will The most common instances are when two proce- ensure that the full reimbursement will be received for the dures are performed in contralateral eyes or defined as primary procedure with the highest value. separate structures. When pars plana vitrectomy (CPT 67036) is performed along Step No. 6: Consider any site of service differential in RVU with repositioning of an IOL (CPT 66825) and sutured IOL and/or allowable. (66825), confirm any NCCI bundles. Table 2 illustrates the NCCI Some surgical CPT codes have different allowables bundles of 66825 and 66682 with an indicator of 1. Because these depending on the place of service (POS): that is, whether two codes are bundled when performed the same day and based they are performed in a facility or nonfacility setting. Facility on RVU value, the case would be billed as 67036 and 66825. sites of service would include surgery performed in an ambu- To explore more on NCCI edits and the criteria for unbun- latory surgery center (POS 24), outpatient hospital (POS 22), dling, review the Retina Today article “Become a Master of or inpatient hospital (POS 21). Nonfacility reimbursement is Retina Coding.”2 paid for procedures performed in the office setting (POS 11). Many commercial payers follow the NCCI edits released by Surgeries that are primarily performed only in a facility do CMS. However, some may create their own bundling rules. not have a site of service differential. Prior to submitting multiple procedures to these payers, con- Table 1 provides examples of retina procedures and their firm any unique bundling rules per insurance carrier. corresponding nonfacility and facility reimbursements. It is important to consider the POS and any site of service differ- Step No. 8: Append the appropriate modifier(s). ential when ranking procedures as primary and subsequent Appropriate anatomic modifiers (-RT, -LT, or -50 for a codes based on fee schedules. The examples in Table 1 outline bilateral procedure) should be appended to surgical codes. In the differences in allowables for CPT codes 67028 and 67228 addition, if the surgery is performed during a global period, when performed in a facility or nonfacility POS. Also note that consider the need for adding the following surgical modifiers CPT code 67036 does not have a site of service differential. preceding the eye modifier: • -58 modifier: a staged or related procedure or service by Step No. 7: Review NCCI edits and commercial payer edits. the same physician during the postoperative period. For all CPT codes identified, review the National Correct (Continued on page 10)

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MAKING THE LEAP TO PRIVATE EQUITY One practice’s experience shows that savvy negotiations at the outset can help to ensure a successful partnership. BY DAVID F. WILLIAMS, MD, MBA

f recent trends in retina, the entry of private equity (PE) investment is perhaps the most impactful, gen- erating intense interest among retina practices and AT A GLANCE

angst among young retina specialists and fellows. s PE firms use capital raised from investors to buy com- Negative perceptions of private equity (PE) include Opanies, with the goal of eventually selling those companies the potential for loss of personal and clinical for a profit. autonomy, adverse effects on quality of care, Make no mistake, the goal of the PE firm is to make money. However, the perception that PE firms routinely constraints on future personal income, and the make decisions that are detrimental to practices to maxi- uncertainty of future transactions. mize profits is not so. Such actions would be antithetical s A carefully constructed legal agreement is critical to the profit motive. Profits are best generated by working constructively with the company’s management to improve for any retina group considering PE. You must operations. Such an approach is currently the rule, not the negotiate detailed protections into the contract to exception and is in the best interest of all stakeholders. safeguard important aspects of your personal and Our group in Minnesota, VitreoRetinal Surgery (VRS), practice autonomy. completed a transaction with a PE firm in September 2020. We had declined previous opportunities to partner with s All physicians in a practice can have equity in the PE but unanimously agreed to join Retina Consultants of PE-backed entity, which has the potential to be America (RCA), a PE-backed national horizontal aggregation of retina practices. Horizontal, in this context, refers to the quite valuable over time and has the possibility all-retina nature of the consortium, as opposed to the more to make up for, or exceed, whatever speculative typical vertical grouping of optometry, general ophthalmol- future income is forgone. ogy, and subspecialties.

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We chose this path because we believe that RCA will FINANCIAL CONSIDERATIONS become an impactful organization of retina specialists, with A practice must have financial characteristics that are both initiatives that will benefit members in terms of educa- acceptable to a PE firm and sufficient to structure a deal that tion, patient care, clinical research, contract negotiations, provides attractive upfront and ongoing compensation to the operations, finances, and practice growth. We believe that physicians. The basic structure of a PE merger is to calculate this national organization including more than 100 retina the practice’s earnings before interest, taxes, depreciation, specialists will lead to greater future success for our practices and amortization (EBITDA) and then to sell a portion of that and for each of us individually. EBITDA to the PE firm at a market multiple. The residual Negative perceptions of PE include the potential for: EBITDA is retained by the physicians as initial compensation. • loss of clinical and personal autonomy, Ongoing physician compensation can still grow as practice • adverse effects on quality of care, profitability increases over time, which is a major goal. This • constraints on future personal income, and structure necessarily results in a decrease in initial annual • the uncertainty of future transactions. income after the deal, which for us was more than offset by the My partners and I at VRS share these concerns, but we upfront financial consideration (including cash and equity). found comfort and optimism as we researched the oppor- This trade-off may be perceived differently by early-, mid-, tunity with RCA. I have no insights about other PE-backed and late-career physicians and especially by retina fellows platforms, but let me explain why my partners and I chose to considering job placement options. The simplistic—and align with RCA. incorrect—interpretation is that seasoned physicians are getting their money upfront and will retire soon, leaving the AUTONOMY younger physicians in the practice to deal with the aftermath Most retina specialists, particularly those in private prac- of the PE deal, saddling them with lower annual incomes in tice, value and jealously guard their autonomy. With RCA, the future. However, this ignores important factors, includ- the principals at the PE firm understand that they are engag- ing the time value of money, the characteristics of an orga- ing with retina practices that are successful because of the nization such as RCA, and the increasing risk to traditional characteristics of the physicians and that interfering with private retina practice. their autonomy would be counterproductive and harmful to Because of the effects of compounding interest, young the value of the investment. physician partners who invest their transaction proceeds Thus, personal and clinical autonomy are enshrined in our wisely have an opportunity to be financially wealthier than legal agreements, and so far no one from RCA or the PE firm their more seasoned physician partners when they approach has joined our offices; in fact, we continue to operate as we the same age. With smart investment over the long term, did prior to the transaction. given the average equity market return over the last 100 A carefully constructed legal agreement is critical for any years, one can expect assets to double every 10 years, ad retina group considering a partnership with PE. You must infinitum. Investors must maintain a long-term perspective, negotiate detailed protections into the contract to safeguard as returns over 1 year, or even 10, are highly unpredictable. important aspects of your personal and practice autonomy. However, over 10- to 20-year rolling periods, equity market VRS has control over schedules, personnel, hiring, and returns have historically been very good. growth decisions. Costly decisions warrant justification and Older physicians’ financial wealth has typically been pains- discussion, but there are no barriers if we are operating con- takingly accumulated over a long period of time. They don’t sistent with past business practice; plus, new initiatives are have the same amount of time for their PE transaction pro- good for VRS. ceeds to compound as do their younger partners. Nonpartner physicians are in a different position. They QUALITY OF CARE don’t own equity in the practice, but they also haven’t Commitment to high-quality patient care is a measure spent decades investing in the practice. However, they can of the character of each physician, with or without a PE negotiate favorable considerations that can place them in a partnership, and this remains a priority for VRS physicians, beneficial financial position, and, again, they can take advan- partner physicians at other RCA practices, and our PE tage of the time value of money. partner. Our success depends on our service to patients and Future physician hires in RCA practices will generally start referring doctors. A decline in the quality of care would be at higher incomes and will become full partners in their RCA- bad for our patients, reputations, practices, business, and the affiliated practices sooner than those who are hired at non-RCA PE investment. practices. They will also benefit from the economies of scale and At VRS, in our first few months under RCA, we have not the greater career stability we expect RCA to provide. seen a decline in our commitment to quality, nor do we Finally, all physicians in a practice (both current and anticipate one. future) can have equity in the PE-backed entity, which has

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the potential to be quite valuable over time and has the (Continued from page 7) possibility to make up for, or exceed, whatever speculative future income is forgone. 10 STEPS TO ENSURE CORRECT CODING OF MULTIPLE PROCEDURES CHANGE IS IN THE AIR Some of the risks and benefits associated with partnering 1. Read the full CPT code descriptor with PE are based on whether and how much the practice of 2. Confirm prior authorization retina will change over the next 30 years. Unfortunately, the 3. Meet payer policy documentation guidelines future is not likely to be as favorable for the field of retina as 4. Identify global periods the past. Significant and unfavorable changes in practice, and 5. Order CPT codes from highest to lowest RVU especially in reimbursement structures, are likely. 6. Consider site of service differential Retina has been lucky, but over the past 20 years we have seen 7. Review NCCI edits one high-powered medical specialty after another brought to 8. Append appropriate modifier(s) heel by a changing health care system. For example, in our region 9. Link appropriate ICD-10-CM codes of Minnesota there are few independent physicians in special- 10. Submit claim and confirm proper payment ties other than ophthalmology and cosmetic surgery; most are employed by large health care systems. Perhaps retina can avoid • -78 modifier: unplanned return to the OR or procedure this fate for a while, but at some point trends against indepen- room by the same physician following an initial procedure dent retina practices are likely to become overwhelming. for a related procedure during the postoperative period. For me, the horizontal nature of RCA, as a pure aggre- • -79 modifier: unrelated procedure or service by the gation of retina specialists, gives us an edge over vertical same physician during the postoperative period. aggregations that include optometry, ophthalmology, and subspecialties. My personal interests are more closely aligned Step No. 9: Link the appropriate ICD-10-CM codes to CPT codes. with fellow retina specialists than they are with a more On form CMS 1500 (Health Insurance Claim Form), link diverse collection of eye care providers. I am confident that the appropriate ICD-10-CM code to each CPT code that our uniform, committed, and cohesive group of physicians supports medical necessity. Each CPT code may have multi- will be able to preserve and protect our prerogatives and our ple ICD-10-CM codes linked or different diagnosis codes per success in future relationships. CPT code on the claim. Confirming that the diagnosis link is After long days at professional conferences in years past, accurately completed on the claim form will reduce denials. I remember talking over dinner and drinks with my friends and colleagues from around the country, each of us extolling Step No. 10: Submit the claim and watch the remittance the attributes of our independent, successful retina practices. advice to ensure that proper payment is received. It occurred to many of us then that if we could combine into The final step is to submit the claim and monitor for cor- a national retina “supergroup” we would be able to respond rect reimbursement. When the remittance advice is received, more effectively to the growing challenges that face all of us. verify that the multiple procedure reduction is appropriate During those times, we couldn’t conceive of a mechanism or (ie, 100% for primary procedure, 50% for subsequent proce- structure to accomplish that goal, and we all went home to dures) and that full reimbursement has been received for the our individual silos. entire claim per the payer fee schedule. Now, RCA has provided us with an opportunity to create some form of that retina supergroup. I am proud to be a MAKE IT A HABIT part of this new concept, and I’m incredibly optimistic about Whenever multiple procedures are performed during the my own future and the future of all of my colleagues around same surgical session, use the checklist of 10 steps outlined the country who choose to join us. n in this article to ensure proper coding, reduce denials, and appropriately maximize your practice’s reimbursement. n

1. Woodke J. Properly Coding Retina Surgeries. Retina Today. Coding Advisor Supplement. July/August 2019. DAVID F. WILLIAMS, MD, MBA 2. Woodke J. Become a Master of Retina Coding. Retina Today. Coding Advisor Supplement. September 2019. n Vitreoretinal Surgeon, VitreoRetinal Surgery, PLLC, Minneapolis/St. Paul, Minnesota n Assistant Clinical Professor of Ophthalmology, University of Minnesota, JOY WOODKE, COE, OCS, OCSR Minneapolis, Minnesota n Coding and Practice Management Executive, American Academy of n [email protected] Ophthalmology, San Francisco n Financial disclosure: Shareholder and/or cofounder (Retina Consultants of n [email protected] America, Covalent Medical, Winning Pitch Challenge, Vestrum Health) n Financial disclosure: None

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0321rtbm_Coding_Feature_Williams.indd 10 2/26/21 11:47 AM PRACTICE MANAGEMENT PRACTICE GROWTH CONSIDERATIONS IN CHALLENGING TIMES Processes to ensure smart business decisions for growth.

BY MARIE CZENKO

n times of slowdown, practices often ask themselves, the first; or the attractiveness of something new that’s “What do we need to grow?” Conversely, practices with either unproven, too good to be true, or a lookalike strong and steady growth ask, “What do we need to do (ie, the “shiny new penny”)? This will illuminate whether to continue to grow?” For both, the thinking may be to leadership is reacting to some external force rather recruit new providers, add new technologies or service than driving action based on internal direction and what Ilines, or expand to new locations. To avoid making a hasty— makes sense to leverage. and likely an ill-advised—decision, practices entertaining • Leverage. What can the practice afford to invest or growth opportunities should base such decisions on analysis borrow to fund growth? Is that amount enough to suc- and research, followed by planning, before launching. Let’s cessfully launch the desired growth opportunity? This is explore each of these decision-making processes to ensure the most vital aspect of the analysis—it’s not what the that thoughtful, well-reasoned business decisions are made practice can afford to spend; it’s what it cannot afford to during these challenging times. lose, and the fiscal responsibility to successfully invest in a solid launch. STEP 1: ANALYZE • Feasibility. What additional resources are needed to sup- Before offering something new, practice leaders should ask port the proposed new offering? Consider whether more themselves a broad range of questions and then analyze their physical space, providers, support staff, or office supplies answers and the resulting data. Topics—and related ques- and equipment are needed. All of these resource con- tions—to consider are: siderations are part of an internal break-even feasibility • Procedures. What are the most frequently asked-for analysis designed to help set goals and strive for the art “foundational” procedures within the practice? Consider of the possible. the marketplace and if practice providers are at maxi- mum capacity for those foundational procedures. Are PROCEDURE VALUE PER HOUR EXPLAINED schedules full, and what is the timeline for the next available appointment? Practices often ask, “What is the profit on a procedure?”, thinking that profit What practice procedures are the most profitable? defines profitability. The reality is that there are two variables to take into account If unsure, a procedure value per hour analysis (see for valuing any procedure: time and money. Consider these two equations: “Procedure Value Per Hour Explained”) may help to • Profit: determine this. Growing the practice’s patient base Cost to the patient – Cost of goods = Gross profit for its most profitable procedures or maxing out • Profitability: its most profitable procedures is a logical first step Gross profit (Cost to the patient – Cost of goods) ÷ Time = Procedure value before investing in something new. per hour • Patients. Are the practice’s patients loyal? Analyze Putting these equations into numbers, let’s consider a $1,000 procedure cost whether they are coming in regularly and at a recom- to the patient and a $480 cost of goods. The gross profit is $520 for the procedure mended frequency. alone. Now consider if that procedure takes 30 minutes to complete. Taking Are patients going somewhere else for services that the practice does or could easily offer, and if so, why? that $520 gross profit and dividing it by the 30 minutes for the procedure, the This requires some thoughtful listening, discussion, and procedure value per hour is now $1,040 ($1,000–$480 = $520/0.5 hour = $1,040). maybe even a survey of the practice’s best patients. Time can also extend to include the time to perform the procedure consultation • Internal motivation. Is the desire to grow or add to and the actual successful conversion rate for a more finite value. the service menu based on current financial health The concept of procedure value per hour is a sensitive analysis, and and opportunity, or is it reactionary to outside influ- incremental changes in any variable can result in a dramatic change. ences, whether the general economy; the desire to be

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0321RTBM_PracticeMgmnt.indd 11 2/26/21 10:32 AM 2/26/21 10:32 AM2/26/21 10:32 AM n What is needed in addition to marketing, staffing, time, marketing, staffing, in addition to What is needed the new opportunity? to fully support and resources the investment for both expected return on What is the market, and what is the internalinternal and external and timeline? break-even amount Reception. Who is trying the new offering? Testimonials. Of those patients, what is their input on generation? the experience and the resulting referral seeingResults. What is the practice thinking, feeling, and in terms of actual results? Ultimately, only the practice and its leadership can decide Take the time to properly assess potential growth oppor- • • comprehensive plan is needed toA well-thought-out, place, backed by research and analysis,With a solid plan in with staff, family,Some practices will execute a soft launch • • • measuring short- Keeping tabs on these metrics is key to Senior Management Consultant, Allergan Practice Consulting Group of Allergan Aesthetics, an Abbvie Company Financial disclosure: None   what is the right new offering to launch. While the motiva- tions to pursue a growth opportunity may vary among prac- tices—eg, address patient wants or needs, invite new patient populations, or be a market leader—the best business approach to vet an opportunity is to analyze internal factors, research external considerations, and create a thoughtful rollout plan and responsive launch strategy. tunities, and, with that, be confident in the great likelihood of success no matter the times. properly target and attract patients and create a positiveproperly target and make the contemplated growthpatient experience to Only then can leadership believe in theopportunity viable. it it into the practice culture, and offer opportunity, embrace to patients with confidence. now is the time for action—to launch. launch. No matterand friends, while others will do a mass to move forwardthe type of launch the practice chooses questions and col- with, in this phase it is still essential to ask lect data (daily), including the following: and planning long- term success, adjusting where necessary, offering that soarsterm growth strategies. A new practice penny; a new offer- and then flattens or falls is the shiny new growth path is oneing that continues on a strong and steady If practice leadersthat will take the practice to the next level. should be confidenthave done their due diligence, then they andthat the new offering will be an asset, complementing enriching the practice. MARIE CZENKO n n DECIDING FACTORS DECIDING FACTORS STEP 4: LAUNCH STEP 4: LAUNCH Who are the target patients (good candidates and/or good loyal practice advocates)? What is the marketing plan to reach that audience, and what resources will the practice need to invest in to create awareness, interest, and engagement—in other words, valid inquiries? What is the return on investment related to retaining that internal patient/annuity or gaining a new patient who can become an annuity? What’s the best pricing model for patients? What is the timeline to marketable launch? What investment is needed for the first 6 months of operations? . Avoid considering what is popular in thetrends. Avoid considering Market a short-term spike doesn’t neces- media today—because opportunity. Rather, focus onsarily equate to genuine their traction are strong and steady.where inquiries and and localized keyword internetIt’s easy to do a general of market trends.search to get a sense inquiring orinterest. Are patients repeatedly Patient be time toasking for a specific offering? If so, it may interest. Whileconduct a patient survey to gauge broad data is a fac- survey results are subjective, that external tor—though not the sole basis—for a decision. - review. Innovation is often a subject of indus Industry articles,try review, whether in the form of pamphlets, of a newor discussions. While peer interest or support the right rea- technology or treatment may seem like one’s ownson to make a decision, it is only valid when in terms ofpractice analysis aligns with the opportunity patient support and financial feasibility. input. Seek expert advice. Engage the trustedAdvisor whoconsultants, accountants, and other professionals leadershipknow the practice and can objectively advise is con- before a final decision is made. If all research will likelyducted by practice leadership, advisor review value, helpingconsist of minimal time but maximum decision.leadership make an educated and fully vetted • • • • • • This is the most often over-looked element when consider- Once the practice leaders have conducted all of the neces- Once the practice leaders have conducted • • • • Do not limit research to one dimension. Research requires Research research to one dimension. Do not limit ing launching a growth opportunity. Questions to ask to flesh out a rollout plan include: sary research and analysis, and only if the opportunity still looks promising, should they take the next step: planning. both internal information—like that gathered in Step 1— that gathered in information—like both internal - with its source being a key consid and external information, below are some external areas prac- eration. Knowing that, focus on in their research efforts whentice leadership should opportunities.considering growth STEP 3: PLAN STEP 3: PLAN STEP 2: RESEARCH STEP 2: RESEARCH RETINA TODAY BUSINESSRETINA TODAY MATTERS | VOL. NO. 1 4,

12 s PRACTICE MANAGEMENT 0321RTBM_PracticeMgmnt.indd 120321RTBM_PracticeMgmnt.indd 12 @RETINATODAY Your Destination for the Latest Developments in #Retina in Print and Online

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@tRetinaToday.indd 56 2/26/21 4:15 PM YOUR MONEY

HOW TO PUT LOW INTEREST RATES TO WORK FOR YOU These three tips can help you take advantage of historically low rates.

BY DAVID B. MANDELL, JD, MBA, AND JASON M. O’DELL, MS, CWM

s we continue to live through COVID-19, much of the as varied as practice real estate mortgages, rental property US economy is hurting. However, a few opportunities mortgages, practice lines of credit, practice equipment have emerged, such as interest rates that—ultimately financing, and even student loans. controlled by the Federal Reserve—are now at an Knowledge of your current loan terms, closing costs, and all-time low. This government policy is intended to an accurate financial model are required to make these Astimulate the economy and give businesses and individuals important financial decisions. easier access to capital, and government officials have indi- cated that the policy will continue for the foreseeable future. Use Premium-Financed Life Insurance A near-0% interest loan policy benefits big banks, which In our books and previous articles, we have explored can borrow at close to 0% and lend profitably, even at low 2 the relative strengths and weaknesses of term and rates. It also benefits big businesses, which can expand their permanent life insurance (whole life, universal life, equity- operations with a near-0% cost of capital. indexed life, etc.). Bottom line: Significant tax, retirement, And ultra-low rates can significantly benefit ophthalmolo- and estate benefits are offered by permanent life insurance. gists and their families. Here, we outline three ways they can Nonetheless, to build up large permanent policies that take advantage of this situation, starting with the most obvi- generate six-figure annual tax-free retirement income, oph- ous and popular, then moving to the more complex. thalmologists generally need to make significant investments into these policies for at least a few years while they work. Refinance Debt Many physicians would like the tax-free retirement income As mortgage rates have now reached all-time lows, but are averse to paying large insurance premiums. 1 most homeowners have already refinanced their home This is where premium financing comes in. One can mortgage or are considering doing so. A simple financial finance these policies during the funding phase, only paying a model can calculate the long-term benefit of refinancing. few percentage points in interest, rather than the entire pre- Many websites have easy-to-understand mortgage mium. Then, typically 10 to 15 years into the plan, when cash comparison calculators, or a mortgage broker can provide values have grown, the cash value can be used to pay off the this analysis. loan principal. What remains is a large debt-free permanent The essence of this analysis is to compare an exist- policy that can be used to generate tax-free income through- ing mortgage with a new mortgage at a lower interest out the physician’s retirement. rate. A thorough knowledge of the current loan terms Although this brief description glosses over a complex and (eg, prepayment penalties) and potential closing costs to significant transaction with a number of risks and success secure the new mortgage is essential. The goal is to calculate factors, the essence of it remains arbitrage; that is, growing the break-even point—the length of time at which paying the policy cash values at rates generally around 5% to 7% the new lower-interest mortgage makes up for the one-time annually, which is higher than typical premium financing additional costs of changing the mortgage. Bottom line: If interest rates. the loan terms are the same and you intend to remain in the Today, those rates have plummeted, and some banks are home well past the break-even point, refinancing may be a offering rates below 3%, often with long-term lock options. As good idea. such, there has never been a better time to engage in this trans- The same concept of refinancing can be applied to loans action since it became mainstream more than 25 years ago.

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0321RTBM_Your_Money.indd 14 2/26/21 10:32 AM YOUR MONEY

BOTTOM LINE [FOR REFINANCING]: IF THE LOAN TERMS ARE THE SAME AND YOU INTEND TO REMAIN IN THE HOME WELL PAST THE BREAK-EVEN POINT, REFINANCING MAY BE A GOOD IDEA.

Leverage Intra-Family Loans for Gift Made Simple, text RETINA to 844-418-1212, or visit and Estate Planning www.ojmbookstore.com and enter promotional code RETINA 3 Often, a core element of sophisticated estate and gift tax at checkout. planning is making loans between family members. Unlike OJM Group, LLC. (“OJM”) is an SEC registered investment loans between unrelated parties, intra-family loans must adviser with its principal place of business in the State of Ohio. charge a minimum interest rate specified by the US Internal SEC registration does not constitute an endorsement of OJM Revenue Service (IRS) to make the loan legitimate. This by the SEC nor does it indicate that OJM has attained a par- applicable federal rate (AFR) is issued by the IRS each month ticular level of skill or ability. OJM and its representatives are so that taxpayers and their advisors can know exactly how in compliance with the current notice filing and registration much interest must be charged in these scenarios. In fact, the requirements imposed upon registered investment advisers IRS issues three specific AFRs: a short-term rate (maturities by those states in which OJM maintains clients. OJM may of 3 years or less), medium-term rate (3 to 9 years), and long- only transact business in those states in which it is registered term rate (maturities greater than 9 years). In January, these or qualifies for an exemption or exclusion from registration rates were 0.14%, 0.52%, and 1.35%, respectively.1 requirements. For information pertaining to the registration Although the specifics go beyond the scope of this article, status of OJM, please contact OJM or refer to the Investment there are myriad ways physicians can transfer wealth tax Adviser Public Disclosure web site www.adviserinfo.sec.gov. efficiently among family members, trusts, and partnerships For additional information about OJM, including fees and when the interest rate on long-term loans is so low. services, send for our disclosure brochure as set forth on Form Such loans can provide tremendous flexibility for physi- ADV using the contact information below. Please read the dis- cians who want to transfer wealth to younger family mem- closure statement carefully before you invest or send money. bers (or to trusts for their benefit) but want a safety valve This article contains general information that is not suitable to bring the funds back to them in case they need it. A loan for everyone. Information obtained from third party sources to the individual or trust can provide that flexibility. If the are believed to be reliable but not guaranteed. OJM makes physician eventually decides that he or she does not need a no representation regarding the accuracy or completeness of portion of the loaned assets back, he or she can forgive the information provided herein. All opinions and views constitute loan using gift or estate tax exemptions. If the physician does our judgments as of the date of writing and are subject to want the assets back, the loan can be kept in force. Either change at any time without notice. The information contained way, by making a loan while interest rates are so low, the herein should not be construed as personalized legal or tax family has built flexibility into its plans at the cost of a tiny advice. There is no guarantee that the views and opinions interest rate dictated by the IRS. expressed in this article will be appropriate for your particular circumstances. Tax law changes frequently, accordingly infor- CONCLUSION mation presented herein is subject to change without notice. All retina specialists should determine how they can best You should seek professional tax and legal advice before capitalize on today’s historically low interest rates. For many, implementing any strategy discussed herein. one or more of these tactics may be beneficial. As always, when implementing any of these options, be sure to work with a trusted and experienced professional advisor. n DAVID MANDELL, JD, MBA n Partner, OJM Group, Cincinnati, Ohio 1. Internal Revenue Service. Section 1274. Determination of Issue Price in the Case of Certain Debt Instruments Issued for n Property. www.irs.gov/pub/irs-drop/rr-21-01.pdf. Accessed February 11, 2021. [email protected] n Financial disclosure: Employee (OJM Group)

Special offers: The authors have recently completed Wealth JASON M. O’DELL, MS, CWM Planning for the Modern Physician. To receive free print cop- n Partner and Financial Consultant, OJM Group, Cincinnati, Ohio ies or ebook downloads of this book or Wealth Management n Financial disclosure: Employee (OJM Group)

VOL. 4, NO. 1 | RETINA TODAY BUSINESS MATTERS 15

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