ARBITRATION AWARD. Injured Person(s) hereinafter referred to as: Eligible injured person

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1 American Arbitration Association New York No-Fault Arbitration Tribunal In the Matter of the Arbitration between: 21st Century Pharmacy Inc (Applicant) - and - New York Central Mutual Fire Insurance Company (Respondent) AAA Case No Applicant's File No. Insurer's Claim File No. NAIC No ARBITRATION AWARD I, Charles Blattberg, the undersigned arbitrator, designated by the American Arbitration Association pursuant to the Rules for New York State No-Fault Arbitration, adopted pursuant to regulations promulgated by the Superintendent of Insurance, having been duly sworn, and having heard the proofs and allegations of the parties make the following AWARD: Injured Person(s) hereinafter referred to as: Eligible injured person Hearing(s) held on 02/10/2017 Declared closed by the arbitrator on 04/04/2017 Kristin Cahill, Esq. from Zelli & Cahill, P.C. participated in person for the Applicant Kristina O'Shea, Esq. from Gullo & Associates, LLP participated in person for the Respondent 2. The amount claimed in the Arbitration Request, $ 2,430.90, was AMENDED and permitted by the arbitrator at the oral hearing. Applicant reduced the amount claimed to $2, pursuant to fee schedule (based on the post hearing submission made). Stipulations WERE NOT made by the parties regarding the issues to be determined. 3. Summary of Issues in Dispute The claimant was the 37 year-old male restrained driver of a motor vehicle that was involved in an accident on 7/15/15. Following the accident the claimant suffered injuries which resulted in the claimant seeking treatment. At issue is the medical necessity of a Page 1/8

2 compounded cream containing Lidocaine HCL, Baclofen, Cyclobenzaprine, VersaPro cream base, and Flurbiprofen prescribed by Timothy Morley, M.D. on 8/9/15 and provided by Applicant the same day. Respondent timely denied reimbursement for the compounded cream based on the 10/29/15 peer review by Frida Goldin, M.D. 4. Findings, Conclusions, and Basis Therefor THIS HEARING WAS CONDUCTED USING THE ELECTRONIC CASE FOLDER MAINTAINED BY THE AMERICAN ARBITRATION ASSOCIATION. ALL DOCUMENTS CONTAINED IN THAT FOLDER ARE MADE PART OF THE RECORD OF THIS HEARING. THE ARBITRATOR SHALL BE THE JUDGE OF THE RELEVANCE AND MATERIALITY OF THE EVIDENCE OFFERED. Based on a review of the documentary evidence, this claim is decided as follows: An applicant establishes a prima facie case of entitlement to reimbursement of its claim by the submission of a completed NF-3 form or similar document documenting the facts and amounts of the losses sustained and by submitting evidentiary proof that the prescribed statutory billing forms [setting forth the fact and the amount of the loss sustained] had been mailed and received and that payment of no-fault benefits were overdue. See, Mary Immaculate Hospital v. Allstate Insurance Company, 5 A.D.3d 742, 774 N.Y.S.2d 564 (2nd Dept. 2004). I find that Applicant established a prima facie case for reimbursement. The burden has shifted to the Respondent as they have raised a medical necessity defense. In order to support a lack of medical necessity defense respondent must "set forth a factual basis and medical rationale for the peer reviewer's determination that there was a lack of medical necessity for the services rendered." See, Provvedere, Inc. v. Republic Western Ins. Co., 2014 NY Slip Op (U) (App. Term 2, 11th and 13th Jud. Dists Respondent bears the burden of production in support of its lack of medical necessity defense, which if established shifts the burden of persuasion to Applicant. See generally, Bronx Expert Radiology, P.C. v. Travelers Ins. Co., 2006 NY Slip Op (App. Term 1 Dept. 2006). As a general rule, reliance on rebuttal documentation will be weighed in light of the documentary proofs and the arguments presented at the arbitration. Moreover, the case law is clear that a provider must rebut the conclusions and determinations of the IME/peer doctor with his own facts. Park Slope Medical and Surgical Supply, Inc. v. Travelers, 37 Misc.3d 19 (2012). The hearing was held open for Applicant "to submit a copy of the fee schedule breakdown referenced at the hearing," which they did. The hearing was also held open for Respondent "to submit a brief reply to this breakdown along with sections of the Red Book that were used in the fee schedule calculation in the denial and the brief by counsel." After follow-up by the AAA, Respondent stated that they weren't going to upload any post hearing documentation. Page 2/8

3 The claimant was the 37 year-old male restrained driver of a motor vehicle that was involved in an accident on 7/15/15. The claimant reportedly injured his neck, low back, and right thigh. There was no reported loss of consciousness. There were no reported lacerations or fractures. Following the accident the claimant was transported by ambulance to King's County Hospital where he was evaluated, treated, and released. On 7/24/15 the claimant presented to Timothy Morley, M.D. with complaints of neck pain rated 6/10, low back pain rated 9/10, and right thigh pain rated 5/10. Cervical examination revealed decreased range of motion [unquantified] and neck pain and stiffness radiating to the right arm/fingers with numbness and burning. There was tenderness C2-C7 and hypertonicity. Compression test was positive. Examination of the lumbar spine revealed pain and stiffness radiating to the right leg with numbness, tingling, and weakness. There was tenderness L5-S1. Straight leg raise was positive on the right at 45. Sensation was normal. Dr. Morley recommended physical therapy, cervical and lumbar MRIs, chiropractic, acupuncture, physical capacity testing, and computerized range of motion and muscle testing. On 7/30/15 the claimant presented to Michael Dauria, D.C. and was initiated on chiropractic treatment. On 7/31/15 the claimant presented to Kazu Acupuncture, P.C. and was initiated on acupuncture care. On 8/9/15 Dr. Morley prescribed a compounded cream containing Lidocaine HCL, Baclofen, Cyclobenzaprine, VersaPro cream base, and Flurbiprofen provided by Applicant the same day and which is at issue here. Respondent timely denied the compounded cream at issue based on the 10/29/15 peer review by Frida Goldin, M.D. After reviewing the claimant's history, treatment, and medical records, Dr. Goldin asserts "according, to the provided documentation, this compounded cream was prescribed by Dr. Morley on 08/09/15. There is no detailed explanation provided by Dr. Morley as to why this particular compounded cream was indicated for this claimant." Dr. Goldin opines "there is no information as to why this compounded cream was medically necessary for this claimant so early in the course of treatment. If this patient required a topical cream, then a regular formulary, not custom compound, and OTC medication could be used. Multiple variations of topical creams and ointments are available over the counter, which are quite effective, and are widely recommended by medical professionals. Those ointments/creams contain pain relieving substances, and are well absorbed through the skin. There is no evidence of this patient's trying any of such OTC creams first. The using OTC external use ointments are commonly accepted standards of medical practice. Additionally, it should be noted that this compound contains Baclofen, which is anti-spasticity medication and Cyclobenzaprine, a muscle relaxant. The compound also contains Lidocaine cream, which is a short acting local anesthetic. Dr. Morley's note dated 07/24/15 states that "medical treatment for the patient consists of analgesics." There is no evidence that patient experienced significant muscle spasms and spasticity; therefore, the components of the compound are not medically indicated and are not necessary. Those medications, along with the anti-inflammatory Flurbiprofen are more effective when taken orally. The dosage of externally used ointments and creams is very questionable as is their efficacy due to wide variation of skin absorption property." Dr. Goldin cites to the AMA definition of medical necessity without indicating how it was violated in this particular case. Page 3/8

4 Where the Defendant insurer presents sufficient evidence to establish a defense based on lack of medical necessity, the burden shifts to the Plaintiff which must then present its own evidence of medical necessity (see Prince on Evidence section 3-104, 3-202). West Tremont Medical Diagnostic PC v. Geico, 13 Misc.3d 131, 824 N.Y.S. 2d 759. Applicant submitted an 11/11/16 peer rebuttal by Muzaffar Zai, D.O. Dr. Zai argues "Dr. Goldin has failed to demonstrate any legitimate reason for lack of medical necessity. Quoting the definition of medical necessity does not determine medical necessity. The patient was not given prescription medication for anyone's convenience, was for an injury, and was within acceptable standards. Dr. Goldin has failed to demonstrate any legitimate reason for lack of medical necessity. Dr. Goldin does not provide any peer referenced journals, research studies, or even a magazine article. Dr. Goldin states that "OTC external ointments are commonly accepted standards of medical practice." In the next paragraph she states, "The dosage of externally used ointments and creams is very questionable as is their efficacy due to wide variation of skin absorption property." So, what we have here are conflicting statements which only succeed in confusing her argument." Dr. Zai explains "many medications that have been traditionally used for one thing have been found to have other uses. These other uses were once considered side effects. Thalidomide first prescribed in the 1950s to pregnant women for morning sickness, was pulled from the market due to birth defects. Despite the potential for harm, thalidomide is once again in use for conditions such as rheumatoid arthritis, Crohn's disease, HIV, and some cancers. Lidocaine is listed as a pain reliever for post-herpetic lesions. More commonly, we know it is used for relief of sunburn, insect bite, and poison ivy. The fact is that every medication in use has effects and side effects. Some of the most popular drugs have a list of side effects longer than a page. The mere mentioning of side effects has not precluded the use of these drugs." Dr. Zai asserts "in this case 21st Century Pharmacy [Applicant] is acting on the basis that a knowledgeable physician examined the patient and prescribed the topical medication because it would enhance patient care. According to, "The Topical Preparations for Pain Relief: Efficacy and Patient Adherence"; Journal of Pain Research 2011, the conclusion of the paper states, "Although only a small number of topical agents are available for use in peripheral and local conditions, increasing evidence supports the efficacy of such preparations for the relief of nociceptive or neuropathic pain. Overall, topical preparations have a good safety profile." Also, from page 16, "Positive effects on quality of life scales and pain are supported by several clinical trials, where up to three applications were noted in 12 hours." Furthermore, from page 17, "Overall, when NSAIDs are applied topically, a high concentration is observed in the dermis and muscles, with less gastrointestinal effects." The study goes on to say, "A systemic review of topical NSAIDs for acute musculoskeletal conditions studied 3455 subjects and concluded that the preparations can provide good levels of pain relief, without the systemic adverse events associated with oral NSAIDs. Positive outcomes were observed with use of diclofenac, ibuprofen, ketoprofen, and piroxicam." Secondly, topical NSAIDs for Acute Pain In Adults; 2010; updated 2015; attempt to put it all together. The 2015 update states. "Topical NSAIDs provided good levels of pain relief in acute conditions such as sprains, strains, and overuse injuries, probably similar to that provided by oral NSAIDs." It also states, "Drug levels in the blood with topical NSAIDs are very much lower than with the same drug taken by mouth. This minimizes the risk of harmful effects." A third study, Topical NSAIDs for Chronic Musculoskeletal Pain In Page 4/8

5 Adults, states, "Topical NSAIDs were significantly more effective than placebo for reducing pain due to chronic musculoskeletal conditions." It also states, "Gastrointestinal adverse events with topical NSAID did not differ from placebo, but were less frequent than with oral NSAIDs." In summary, the topical application of pain medications have positive results and are safer than oral medication of the same type. The Standard of Care Doctrine states that the level at which an ordinary, prudent professional having the same training and experience in good standing in a same or similar community would practice under the same or similar circumstances. A physician (any type) should be interested in obtaining as much information as possible in order to provide the best possible treatment to his/her patients in order to achieve the best possible outcome." Dr. Zai concludes "it is a physician's responsibility to determine a proper diagnosis in order to treat the patient properly. A physician should use any tools at his disposal that will help determine a diagnosis and assist in the type of treatment an individual needs. It is difficult for any licensed physician to detect the exact nerve root level of pain without any diagnostic testing. It is a treating clinician's responsibility to determine the significance of any traumatic injury and diagnose the patient properly in order to provide the proper course of treatment." Respondent submitted an 11/17/16 peer addendum by Frida Goldin, M.D. Dr. Goldin replies "In the rebuttal letter, Dr. Zai stated, "Many medications that have been traditionally used for one thing have been found to have other uses. These other uses were once considered side effects. Thalidomide first prescribed in the 1950s to pregnant women for morning sickness, was pulled from the market due to birth defects. Despite the potential for harm, Thalidomide is once again in use for conditions such as rheumatoid arthritis, Crohn's disease, HIV, and some cancers." This statement does not apply to the discussion of the necessity of the compound ointment." Dr. Goldin asserts "further, Dr. Zai noted, "Lidocaine is listed as a pain reliever for post-herpetic lesions. More commonly, we know it is used for relief of sunburn, insect bite, and poison ivy." Here, Dr. Zai contradicts himself, since this case does not include any of the listed by Dr. Zai possible uses for Lidocaine." Dr. Goldin opines "as noted in my peer review, Dr. Morley initially evaluated this claimant on 07/24/15 and recommended physical therapy treatment. According to the provided information, the patient was also started on chiropractic and acupuncture treatments. There is no information as to why this compounded cream was medically necessary for this claimant so early in the course of treatment. As stated in my peer review, if this patient required a topical cream, then a regular formulary, not custom compound, and OTC medication could be used. Dr. Zai indicated in the rebuttal letter. "It is a physician's responsibility to determine a proper diagnosis in order to treat the patient properly, a physician should use any tools as his disposal that will help determine a diagnosis and assist in the type of treatment an individual needs. It is difficult for any licensed physician to detect the exact nerve root level of pain without any diagnostic testing. It is treating clinician's responsibility to determine the significance of any traumatic injury and diagnose the patient properly in order to provide the proper course of treatment." This statement hardly, if not at all, reflects the discussed use of externally used ointments. As noticed in my peer review, multiple variations of topical creams and ointments are available over the counter, which are quite effective, and are widely recommended by medical professionals. Those ointments/creams contain pain relieving substances, and are well absorbed through the skin. There is no evidence of this patient's trying any of such OTC creams first. OTC Page 5/8

6 external use ointments are commonly accepted standards of medical practice. Additionally, as was noted in my peer review, this compound contains Baclofen, which is anti-spasticity medication and Cyclobenzaprine, a muscle relaxant. The compound also contains Lidocaine cream, which is a short acting local anesthetic. Dr. Morley's note dated 07/24/15 states that "medical treatment for the patient consists of analgesics." Dr. Morley fails to comment/ respond to the fact that there was no medical necessity for anti-spasticity and muscle relaxant medications. There is no evidence that patient experienced significant muscle spasms and spasticity; therefore, the components of the compound are not medically indicated and are not necessary. Therefore, based on the above conclusions, my opinion regarding this case remains unchanged: compounded cream provided to the claimant on 08/09/15 was not medically justified." Dr. Goldin again cites to the AMA definition of medical necessity without indicating how it was violated in this particular case. In her peer review Dr. Goldin notes that there wasn't a detailed explanation provided by Dr. Morley in the submitted record why this particular compounded cream was indicated for this claimant. Dr. Zai does not sufficiently address this point or explain why the topical compound pain cream was provided here based on the claimant's specific signs and symptoms. Dr. Goldin also discussed several components of the cream and why their use here would be inconsistent with the claimant's specific signs and symptoms. In his rebuttal Dr. Zai discussed other medications and topical NSAIDs generally. As noted by Dr. Goldin in her addendum several of these statements are inapplicable to the particular compounded cream prescribed here. After a careful review of the record, and considering the oral arguments of the parties, I am not persuaded by Dr. Zai's rebuttal or by the medical records, and find that Applicant failed to overcome Dr. Goldin's opinion that the compound pain cream was not medically necessary. Accordingly, the claim is denied in its entirety. 5. Optional imposition of administrative costs on Applicant. Applicable for arbitration requests filed on and after March 1, I do NOT impose the administrative costs of arbitration to the applicant, in the amount established for the current calendar year by the Designated Organization. 6. I find as follows with regard to the policy issues before me: The policy was not in force on the date of the accident The applicant was excluded under policy conditions or exclusions The applicant violated policy conditions, resulting in exclusion from coverage The applicant was not an "eligible injured person" The conditions for MVAIC eligibility were not met The injured person was not a "qualified person" (under the MVAIC) The applicant's injuries didn't arise out of the "use or operation" of a motor vehicle The respondent is not subject to the jurisdiction of the New York No-Fault arbitration forum Page 6/8

7 Accordingly, the claim is DENIED in its entirety This award is in full settlement of all no-fault benefit claims submitted to this arbitrator. State of New York SS : County of Nassau I, Charles Blattberg, do hereby affirm upon my oath as arbitrator that I am the individual described in and who executed this instrument, which is my award. 05/04/2017 (Dated) Charles Blattberg IMPORTANT NOTICE This award is payable within 30 calendar days of the date of transmittal of award to parties. This award is final and binding unless modified or vacated by a master arbitrator. Insurance Department Regulation No. 68 (11 NYCRR ) contains time limits and grounds upon which this award may be appealed to a master arbitrator. An appeal to a master arbitrator must be made within 21 days after the mailing of this award. All insurers have copies of the regulation. Applicants may obtain a copy from the Insurance Department. Page 7/8

8 ELECTRONIC SIGNATURE Document Name: Final Award Form Unique Modria Document ID: 3cea261317f5c5819dfc079992a81764 Electronically Signed Your name: Charles Blattberg Signed on: 05/04/2017 Page 8/8

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