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Medicare 2007 and Beyond – Impact on AMD William T. Koch, COA, COE, CPC Associate Consultant Corcoran Consulting Group San Bernadino, California History of AMD Treatment Focal laser treatment – “Hot” laser – Photocoagulation Ocular photodynamic therapy – Intravenous injection of verteporfin – “Cold” laser used to activate drug Anti-VEGF agents – Intravitreal injection – Antiangiogenic therapy Challenges Genesis of new treatments – Ocular photodynamic therapy – Intravitreal antiangiogenic therapies Coding and reimbursement challenges Ocular Photodynamic Therapy Coding CPT: 67221 Unilateral treatment CPT: 67225 Second eye, single session HCPCS: J3396 (verteporfin) Description of drug in comment field (box 19) Intravitreal Injections for Wet AMD Anti-VEGF Agents Antiangiogenic therapy Pegaptanib sodium injection – On-label Ranibizumab injection – On-label Pegaptanib Sodium Injection Received FDA approval in December of 2004 Launched in January of 2005 Treatment of wet AMD (362.52) Payment based on Average Selling Price + 6% HOPD: Use C9128 Pegaptanib Sodium Injection Coding CPT: 67028 – Intravitreal injection HCPCS : J2503 – Injection, pegaptanib sodium Description of drug in comment field (box 19) Ranibizumab Injection FDA approval June 30, 20061 Treatment of wet AMD (362.52) Payment based on Average Selling Price + 6% 1. http://www.fda.gov/bbs/topics/NEWS/2006/NEW01405.html Ranibizumab Injection Coding CPT: 67028 – Intravitreal injection HCPCS: J3590 – Unclassified biologics Description of drug in comment field (box 19) Intravitreal Injections for Wet AMD Anti-VEGF Agents Antiangiogenic therapy – Bevacizumab Off-label Intravitreal Injection of Bevacizumab Treatment of Wet AMD Carriers without published guidelines for wet AMD – Wheatlands (KS, NE, MO, West) – NHIC (CA, ME, MA, NH, VT) Proceed with caution – Carrier may reimburse for wet AMD (362.52) – Carrier may follow “unlabeled use of drug” policy Monitor carrier website Unlabeled Use of Drug “If a medication is determined not to be reasonable and necessary for diagnosis or treatment of an illness or injury according to these guidelines, the carrier excludes the entire charge (ie, for both the drug and its administration). Also, carriers exclude from payment any charges for other services (such as office visits) which were primarily for the purpose of administering a noncovered injection (i.e., an injection that is not reasonable and necessary for the diagnosis or treatment of an illness or injury). . . ” Source: MBPM Chapter 15, §50.4.2 Intravitreal Injection of Bevacizumab Off-label use when injected in the eye – Wet age-related macular degeneration – Clinically significant diabetic macular edema – Macular edema from central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO) Vigorous informed consent needed – Off-label status – Absence of clinical studies for ophthalmic use Intravitreal Injection of Bevacizumab Utilize an Advance Beneficiary Notice (ABN) Coding – CPT: 67028 GA – Intravitreal injection* – HCPCS: J3490 GA – Unclassified drugs – HCPCS: J3590 GA – Unclassified biologics – HCPCS: J9035 GA – Injection, bevacizumab – Description of drug in comment field (box 19) *Some Medicare carriers require 67299-GA Minor or Major Procedure? Minor procedure – Postoperative period of 0 or 10 days Major Procedure – Postoperative period of 90 days Intravitreal Injection Minor procedure – CPT Code 67028 – Postoperative period = 0 days Minor Procedure Included in surgery package – Same-day exam usually bundled – Includes supplies Source: MCPM, Chapter 12, §40.1C Billing Office Visit with Minor Procedure “CPT Modifier 25 – Significant Evaluation and Management Service By Same Physician On Date of Global Procedure Pay for an evaluation and management service provided on the day of a procedure with a global fee period if the physician indicates that the service is for a significant, separately identifiable evaluation and management service that is above and beyond the pre- and post-operative work of the procedure.” Source: MCPM, Chapter 12, §40.2.A8 Billing Office Visit with Minor Procedure “Evaluation and Management Service Resulting in the Initial Decision to Perform Surgery …..where the decision to perform the minor procedure is typically done immediately before the service, it is considered a routine preoperative service and a visit or consultation is not billed in addition to the procedure.” Source: MCPM, Chapter 12, §40.2A4 Modifier -25 Significant separate E/M services on the day of a minor surgery, ie, new patient to practice 99243-25 362.52 wet AMD 67028 362.52 wet AMD Office Visit—Established Wet AMD CC: S/P intravitreal injection x 4 wk OD; recheck wet AMD OD, patient states vision still poor Dx: wet AMD OD unresolved Tx: intravitreal injection OD today Hx: healthy Exam: VA, SLE, DFE CPT = 67028 RT S/P = status post; OD = right eye; VA = visual acuity; SLE = slit lamp examination; DFE = dilated fundus examination. Modifier -25 Significant separate E/M services on the day of a minor surgery, ie, to cope with bilateral disease 92012-25 362.51 dry AMD RT 67028 362.52 wet AMD LT National Correct Coding Initiative (NCCI) NCCI – Bundles – Mutually exclusive – Quarterly publication Published at www.cms.gov/physicians/cciedits/ NCCI Edits Procedure 67028 Bundles 36000 36410 37202 62318 62319 64415 64416 64417 64450 64470 64475 67500 69990 90760 90765 90772 90774 90775 J2001 67500 Retrobulbar injection; medication Paracentesis Some ophthalmologists remove aqueous humor from the anterior chamber prior to an intravitreal injection Paracentesis (CPT 65800 or 65805) is performed as a prophylactic measure to avoid elevating intraocular pressure Since both of these CPT codes carry the “separate procedure” designation, and the paracentesis is only performed as prelude to the intravitreal injection, the paracentesis is considered to be an incidental part of the total service and no additional claim is merited Injection for Complication Performed during postoperative period of another surgery Performed in office – Included in global surgery package Performed in the OR – Covered – Modifier 78 (return to the OR) Staged (preplanned) – Covered – Modifier 58 (staged or related) Source: MCPM, Chapter 12, §40.1A Wet AMD Dx: submacular hemorrhage AMD OD Tx: pars plana vitrectomy (PPV) Plan: intravitreal injection following PPV in office Can you be reimbursed? For what? Wet AMD Dx: submacular hemorrhage AMD OD Tx: pars plana vitrectomy Plan: intravitreal injection following PPV in office Claim: 67038 for surgery Claim: 67028 58RT (intravitreal injection) pegaptanib/ranibizumab/bevacizumab Modifier 58: staged or related procedure during the postoperative period Wet AMD Dx: wet AMD OD Tx: intravitreal injection Can you be reimbursed? For what? Wet AMD Dx: wet AMD OD Tx: intravitreal injection Claim: 67028 RT (intravitreal injection) J2503 (pegaptanib) J3590 (ranibizumab) J3490/J3590/J9035 (bevacizumab) Wet AMD Hx: S/P intravitreal injection OD x 5 weeks Dx: wet AMD OD, unresolved Tx: intravitreal injection OD Can you be reimbursed? For what? Why? Wet AMD Hx: S/P intravitreal injection OD x 5 weeks Dx: wet AMD OD, unresolved Tx: intravitreal injection OD Claim: 67028 RT (intravitreal injection) J2503 (pegaptanib) J3590 (ranibizumab) J3490/J3590/J9035 (bevacizumab) 67028 = 0 days postoperative period Wet AMD Dx: wet AMD OS Tx: intravitreal injection OS, return 1 wk for PDT OS Can you be reimbursed? For what? Why? OS = left eye; PDT = photodynamic therapy. Wet AMD Dx: wet AMD OS Tx: intravitreal injection OS, return 1 wk for PDT OS Claim: 67028 LT (intravitreal injection) J2503 (pegaptanib) J3590 (ranibizumab) J3490/J3590/J9035 (bevacizumab) Wet AMD Hx: S/P intravitreal injection 1 week OS Dx: wet AMD OS Tx: photodynamic therapy OS Can you be reimbursed? For what? Why? Wet AMD Hx: S/P intravitreal injection 1 week OS Dx: wet AMD OS Tx: photodynamic therapy (PDT) OS Claim: 67221 LT (PDT) J3396 (verteporfin) Operative Reports Pre- and postoperative diagnoses Indications for surgery Description of surgery Discharge instructions Conclusion Laser treatments – Focal laser CPT: 67220 – Photodynamic therapy CPT: 67221/67225 HCPCS: J3396 (verteporfin) Conclusion Antiangiogenic therapies – Pegaptanib sodium CPT: 67028 (intravitreal injection) HCPCS: J2503 (pegaptanib sodium) – Ranibizumab CPT: 67028 (intravitreal injection) HCPCS: J3590 (ranibizumab) – Bevacizumab CPT: 67028 (intravitreal injection) HCPCS: J3490/J3590/J9035 Bevacizumab/carrier specific Conclusion Future of AMD treatment Clinical research ongoing – Private sector – NEI/NIH Improvement of existing therapies Combination therapies using current methods Overview of AMD Therapy Sharam Danesh, MD Vitreoretinal Surgeon Associated Retina Consultants, Ltd. Associate Professor Department of Ophthalmology Retina Services University of Arizona Phoenix, Arizona Introduction Definition of age-related macular degeneration (AMD) A constellation of degenerative macular abnormalities, strongly associated with age These degenerative abnormalities are along a spectrum of changes from normal aging to severe AMD Classifications Dry AMD – Non-neovascular changes Drusen Abnormalities of the retinal pigment epithelium Wet AMD – Neovascular changes Choroidal neovascularization Dry AMD Dry AMD is more common – Dry AMD 85% – Wet AMD 15% Severe visual loss – Dry AMD 15% – Wet AMD 85% Drusen Round and yellow lesions Located in the outer retina of the posterior pole Accumulation of material in Bruch’s membrane Failure of the debris from the retinal pigment epithelium cells to cross the Bruch’s membrane into the choriocapillaris Courtesy of Dr. S. Danesh. Dry AMD Geographic atrophy The end result of the atrophic form of AMD Round oval area of hypopigmentation and apparent absence of the retinal pigment epithelium Choroidal vessels are more visible Courtesy of Dr. S. Danesh. Neovascular AMD Choroidal neovascular membrane is the hallmark of wet AMD Neovascular vessels grow through the Bruch’s membrane into the sub–retinal pigment epithelium and sub–retinal space The fibrovascular complex can destroy the normal structure of the RPE and retina Secondary exudation or hemorrhage from neovascular vessels may occur Available at: http://health.yahoo.com/media/mayoclinic/images/image_popup/r7_wetmacdegen.jpg. Accessed June 26, 2007. Mayo Foundation for Medical Education and Research. All rights reserved. Reprinted with permission. Neovascular AMD Clinical finding of choroidal neovascular membrane A grey subretinal membrane Subretinal hemorrhage Subretinal fluid Courtesy of Dr. S. Danesh. Neovascular AMD Symptoms of choroidal neovascular membrane Blurred central vision Central scotoma Metamorphopsia (distortion) Courtesy of Dr. S. Danesh. Neovascular AMD Disciform scar End-stage choroidal neovascular membrane A fibrovascular scar is formed in the subretinal space Associated with severe loss of central vision Not yet amenable to any treatments Courtesy of Dr. S. Danesh. Severe Visual Loss in AMD Geographic atrophy in the center of macula Choroidal neovascular membrane Courtesy of Dr. S. Danesh. Risk Factors and Preventions Excellent evidence – – – – – – Age Race/ethnicity Family history Smoking Antioxidant vitamins: C, E, beta carotene Zinc Some evidence – Lifelong exposure to blue light – Lutein/zeaxanthin – Omega 3 long chain fatty acids No evidence – Exposure to UV light Current and Potential Treatments Photodynamic Therapy Treatment with a photosensitizing dye Proposed mechanism of action: Verteporfin is activated by light Oxygen radicals Endothelial damage and thrombus formation Occlusion of neovascular vessels Treatment of AMD with Photodynamic Therapy (TAP) Study Conclusions Photodynamic therapy is clinically beneficial for patients with choroidal neovascular membrane with >50% classic component This beneficial effect only slows visual loss at best TAP Study Group. Arch Ophthalmol.1999;117:1329. Anti-VEGF Therapies in Eye Diseases Pegaptanib* Ranibizumab* Bevacizumab VEGF-trap siRNAs Pegaptani b Ranibizuma b oAvastin Bevacizumap oVEGF-trap Squalaminelactate lactate Squalamine Anecortave *Approved by FDA for AMD VEGF = vascular endothelial growth factor; siRNAs = small interfering RNAs; PDT = photodynamic therapy; TTT = transpupillary thermotherapy; EBRT = external beam radiation. The Eye Digest. http://www.agingeye.net/maculardegen/maculardegennewdevelopments.php The Eye Digest. www.agingeye.net. University of Illinois Eye & Ear Infirmary. Pegaptanib—VISION Results In 2 combined randomized, doublemasked, sham-controlled trials, pegaptanib Significantly reduced the proportion of patients who lost >15 letters Reduced the progression to legal blindness Chakravarthy U, et al. Ophthalmology. 2006;113:1508. Ranibizumab* and Bevacizumab Affinity maturation (140×) RANIBIZUMAB 48 kDa (rhu Fab v1) Humanization Construction of full length antibody Mouse Anti-VEGF-A mAb (~150 kDa) *FDA approved for AMD. Courtesy of Dr. S. Danesh. (Fab-12) BEVACIZUMAB 149 kDa Ranibizumab—MARINA Results ≥15-Letter Gain from Baseline 100 90 80 70 60 50 40 30 20 10 0 94.6* 90.0* 62.2 52.9 Sham Ranibizumab Sham Ranibizumab 0.5 mg (n = 238) 0.5 mg (n = 238) (n = 240) (n = 240) Month 12 % of Subjects % of Subjects <15-Letter Loss from Baseline 100 90 80 70 60 50 40 30 20 10 0 Sham (n = 238) Ranibizumab 0.5 mg (n = 240) 33.3 33.8 4.6 Month 12 3.8 Month 24 Month 24 MARINA = Minimally Classic/Occult Trial of Anti-VEGF Antibody Ranibizumab in the Treatment of Neovascular Age-Related Macular Degeneration. With permission from Rosenfeld PJ, et al. N Engl J Med. 2006;355:1419-1431. Copyright 2006. Massachusetts Medical Society. All rights reserved. Ranibizumab—MARINA Results Mean Change in Visual Acuity Over Time Through Month 24 Sham (n = 238) ETDRS Letters 10 Ranibizumab 0.5 mg (n = 240) +7.2 +6.6 5 0 2 4 6 8 10 12 14 16 18 20 22 24 -5 -10 -15 -10.4 Month -14.9 ETDRS = Early Treatment of Diabetic Retinopathy Study. With permission from Rosenfeld PJ, et al. N Engl J Med. 2006;355:1419-1431. Copyright 2006. Massachusetts Medical Society. All rights reserved. Ranibizumab—ANCHOR Results ≥15-Letter Gain From Baseline at Month 12 <15-Letter Loss From Baseline at Month 12 96.4 100 90 90 80 80 70 % of Subjects % of Subjects 100 64.3 60 50 40 30 70 60 50 40 30 20 20 10 10 0 0 PDT (n = 143) Ranibizumab 0.5 mg (n = 139) 40.3 5.6 PDT (n = 143) Ranibizumab 0.5 mg (n = 139) PDT = photodynamic therapy. With permission from Brown DM, et al. N Engl J Med. 2006;355:1432-1444. Copyright 2006. Massachusetts Medical Society. All rights reserved. Ranibizumab—ANCHOR Results Mean Change in Visual Acuity Over Time Through Month 12 PDT (n = 143) Ranibizumab 0.5 mg (n = 139) ETDRS Letters 15 +11.3 10 5 0 1 2 3 4 5 6 7 8 9 10 11 12 -5 -10 Month –9.5 -15 PDT = photodynamic therapy; ETDRS = Early Treatment of Diabetic Retinopathy Study. With permission from Brown DM, et al. N Engl J Med. 2006;355:1432-1444. Copyright 2006. Massachusetts Medical Society. All rights reserved. CATT Comparison of AMD Treatments Trial Multicentered randomized clinical trial involving 40 centers Group 1 Ranibizumab q 4 wk x 1y then randomize to bevacizumab PRN or q 4 wk Group 2 Bevacizumab q 4 wk x 1y then randomize to ranibizumab PRN or q 4 wk Group 3 Ranibizumab PRN Group 4 Bevacizumab PRN VEGF Trap Fusion protein of key domains from human VEGF receptors 1 and 2 with human IgG1 Fc High affinity: binds VEGF more tightly than native receptors or monoclonal antibodies Blocks all VEGF-A isoforms and placental growth factor (PIGF) Smaller than an antibody Kd 10–30 pM Kd 100–300 pM Kaiser PK. Presented at: 2006 Retinal Physician Symposium. Paradise Island, Bahamas, May 31, 2006. http://www.retinalphysician.com/article.aspx?article=100264 Courtesy of Dr. S. Danesh. VEGF Trap 0.5 mg q 4 wk Phase II study of intravitreous VEGF trap in patient with neovascular AMD 0.5 mg q 12 wk Initial 12 weeks 2 mg q 4 wk 2 mg q 12 wk 4 mg q 4 wk Followed by 9 months of PRN dosing Small Interfering RNAs Natural pathway Pegaptani b Ranibizumab Squalamine Anecortave lactate Cand5: VEGF SiRNA Sirna-027: VEGF receptor siRNA The Eye Digest. http://agingeye.net/maculardegen/maculardegennewdevelopments.php The Eye Digest. www.agingeye.net. University of Illinois Eye & Ear Infirmary. Sarnow P, et al. Nat Rev Microbiol. 2006;4:651. Future Directions—Combination/Triple Therapies Early trial of photodynamic therapy with verteporfin + bevacizumab + dexamethasone Visual acuity improved in most of the 59 patients treated 1 cycle only required, with occasional supplementation with intravitreal injections of bevacizumab Augustin AJ, et al. Presented at: Joint Meeting of AAO and APAO. Las Vegas, Nevada; November 11-14, 2006. Conclusions Photodynamic therapy is beneficial for patients with choroidal neovascular membrane with >50% classic component, but only slows visual loss at best Pegaptanib maintains visual acuity Ranibizumab maintains and improves visual acuity Potential future therapies for AMD include bevacizumab, VEGF trap, siRNAs, and combination/triple regimens AMD Best Practice for Best Patient Care: Improving Patient Processes Angela M. Chambers, RN, MBA Executive Director Associated Retina Consultants, Ltd. Phoenix, Arizona Improving Patient Flow Establish a defined practice protocol for treatment Educate staff on protocol Provide injections and therapies in a defined room; removing this task from clinic will improve regular clinic flow Establish a separate schedule for this procedure area that runs in conjunction with the established clinic schedule Schedule patients every 15 minutes Improving Patient Flow Schedule 1 person to handle the procedure area Define a protocol that addresses patient education pre- and postprocedure Make sure to provide written educational information to the patient; this will eliminate unnecessary phone calls Establish uniformity in set-up for procedure to streamline cost Improving Patient Flow Call doctor to the procedure room after patient is prepped and ready for the procedure Follow defined protocol for patient follow-up Total time for patient from check-in to check out is 15–20 minutes Have patient complete satisfaction survey to determine areas of improvement Processing of Claims and Collections Verify patient eligibility Collect co-pays and deductible amounts at time of service Educate all staff on proper coding for AMD Utilize pharmaceutical reimbursement management team for problems with specific carriers regarding drug reimbursement Identify proper Medicare Secondary Payer (MSP) type prior to claim submittal to avoid rejections Drug Inventory Establish a system to track drug inventory Have all drugs delivered to 1 central location; disburse to other locations after labeling Label each drug with a specific identifier number that will correspond to inventory log Make 1 person in each office responsible for drug inventory received Drug should not be dispensed till payer source is identified Reimbursement Strategies Contact insurance carriers and request a written response regarding payment policy on drug and procedure Establish a timeline for response, ie, 5 days Outline in your request what your action will be if you do not get a response in identified timeframe, eg, collect from patient prior to procedure etc. Reimbursement Strategies Patients not treated until payer source is identified Payment requested upfront for noninsured patients Billing department should check appointment logs and verify eligibility at least 24 hours prior to procedure Reimbursement Strategies Utilize your State Department of Insurance to intercede in disputes with your insurance carriers Every insurance carrier has an appeals process Patient is required to initiate the process The final stage of the appeals process requires an outside review The majority of the time when an outside review is done they err on the side of the provider Reimbursement Strategies Insurance carriers do not like having the State Department of Insurance involved in the claims process Once they are called in to investigate a claims issue they can expand their focus The Department of Insurance notifies the patient, provider, and carrier of the decision If the carrier is found to be at fault, they require the carrier to pay the claim with interest within 5 days Efficiencies that Ensure Optimal Patient Care Maximize your space to create better patient flow Remove bottlenecks in the back office by providing procedures in a separate area Redefine scheduling scenarios to fast-track patients and decrease wait times in clinic Redefine the check-in process to assure an efficient streamlined process Mail, e-mail, or post on website, information about required paperwork for patient check-in process; on appointment day, patients arrive with information in hand Reminder Form Example (Printed on Brightly Colored Paper) You are scheduled for an intravitreal injection in our Fast-Track Clinic Date_______ Time______Location_____ Please do not wear any cosmetics on appointment date We advise that you arrange for a driver to transport you home following injection You have been given a prescription for an antibiotic, which will need to be filled prior to the injection date If you have any questions, please telephone us at 602-242-4928 Conclusions Look at all your clinic processes critically Identify areas of the greatest bottleneck to patient process and flow Think outside of the box Solicit suggestions and information from all parties involved, ie, providers, staff, patients, outside observers. Some of our best solutions have come from this process Conclusions Streamline your work space and maximize space that can be used for revenueproducing endeavors Paperwork is the largest waste of labor. By streamlining the paper process, efficiencies improve and costs decrease Develop instructional information for patients regarding procedures and processes. This will decrease questions and calls to the office as well as labor costs Conclusions By restructuring work processes, you will improve efficiency, increase revenue, decrease cost, increase productivity, and streamline workflow, while improving the overall patient experience in your practice