Persius/imr-appeals huggingface dataset:
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary:  An enrollee has requested Opana ER for treatment of his back pain. The physician reviewer found that based on the clinical documentation submitted for review, the medical necessity for Opana ER has not been established. Such narcotics are presently indicated for severe cancer pain in patients who are opioid tolerant and with a limited life expectancy. The patient has non-malignant chronic pain, which will often worsen or recur as a result of opioid rebound. The current standard of care for chronic pain is treatment in a multidisciplinary practice to include physical therapy, massage therapy, cognitive behavioral therapy, and injections to help reduce pain. In addition, high dose opiates may also cause adverse outcomes and therefore Opana ER is not indicated. Ballantyne and Mao reported that prolonged use of high dose opiates might induce tolerance, abnormal pain sensitivity, and hormonal effects. The aim of current guidelines is to protect patients from the adverse effects of opioid therapy. For the reasons provided, the patients request for Opana ER is not medically necessary.   Final Result: The reviewer determined that the requested medication is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.  Credentials/Qualifications: The reviewer is board certified in anesthesiology with sub-specialty certification in pain medicine and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Harvoni 90/400 mg for 12 weeks for treatment of his hepatitis C virus. Findings:  The physician reviewer found that according to the joint guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), all patients with chronic hepatitis C should be treated except those with limited life expectancy due to non-liver-related conditions. The guidelines recommend that all patients should be treated, regardless of fibrosis stage. Additionally, the guidelines report resistance associated variants are only relevant in certain instances in treatment naive patients, such as treatment with simeprevir or elbasvir/grazoprevir. The guidelines recommend that non-cirrhotic treatment naive, genotype 1 patients should be treated with Harvoni for 12 weeks. These recommendations are based on multiple randomized clinical trials, and the medication regimen is U.S. Food and Drug Administration approved for all patients with chronic hepatitis C, genotype 1 regardless of fibrosis stage. AASLD/IDSA guidelines cite data showing reduced survival with delayed treatment. Final Result: The reviewer determined that the requested medication regimen is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is board certified in internal medicine with sub-specialty certification in gastroenterology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/ Case Summary: At issue is whether the Dupixent (dupilumab) subq injections for severe atopic dermatitis (AD) are medically necessary to treat the patients medical condition. The patient has extremely severe atopic dermatitis unresponsive to previous topical and systemic therapy. Dupixent is Federal Drug Administration (FDA) approved for the treatment of atopic dermatitis. Dupixent is appropriate for this patients AD. D'Ippolito et al 2018 reports that the topical steroids are categorized according to their potency and vasoconstrictive properties. All topical steroids can be applied once or twice a day but should not be used for more than 4 weeks. The topical inhibitors (such as tacrolimus or cyclosporine), cause less skin atrophy compared with the topical steroids; however, they do cause more burning and stinging and are accompanied by a boxed warning of an increased risk of lymphomas with long-term use. Systemic agents, such as oral corticosteroids, cyclosporine, azathioprine, and mycophenolate, may also be used for severe, refractory AD. In 2017, the FDA approved injectable dupilumab (Dupixent), which is indicated for the treatment of adults with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupilumab can be used with or without topical corticosteroids. Boguniewicz et al 2018 reports that dupilumab acts by blocking signaling, and inhibiting epidermal cell differentiation and synthesis of lipids and antimicrobial peptides. Dupilumab received FDA approval in March 2017 for adult patients with moderate to severe AD who had an inadequate response to, or could not use, topical therapy. It is an option for patients whose previous treatments have failed. Treatment with dupilumab was associated with major improvements in AD-associated symptoms, including pruritus and anxiety and depression. Vangipuram et al 2017 reports that dupilumab has demonstrated efficacy by reducing clinical activity and symptoms. It also has a favorable safety profile. Dupilumab (Dupixent) recently gained FDA approval for patients with moderate-to-severe AD.                                                      Final Result: The reviewer determined that the requested service is medically necessary for the treatment of the enrollees medical condition. Credentials/Qualifications: The physician reviewer is board certified in dermatology        and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or similar medical condition.
Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for genetic testing for evaluation of the enrollees melanoma. Findings:  The 3 physician reviewers found that the physician reviewer found there is a lack of support for the services at issue in this patients case. In this clinical setting, the standard of care is wide excision to obtain clear tumor margins. Long-term follow-up would include annual skin examinations, history and physical examination every six to twelve months for five years, then annually as clinically indicated, as well as imaging as indicated to investigate specific signs or symptoms. The National Comprehensive Cancer Network guidelines state that routine/baseline testing of primary melanomas is not recommended before or after sentinel node biopsy outside of a clinical study. The DecisionDx-Melanoma test does not have a role in determining which patients are candidates for adjuvant immunotherapy, either as a standard of care or as part of clinical trials. All told, genetic testing was not likely to have been of greater benefit than other methods of evaluating this patient. Final Result: The 3 reviewers determined that the The reviewers determined that the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: Physician reviewer number one is board certified in internal medicine with sub-specialty certification in medical oncology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.Physician reviewer number two is board certified in internal medicine with sub-specialty certification in medical oncology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.Physician reviewer number three is board certified in internal medicine with sub-specialty certification in medical oncology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned

The parents of a 14-year-old male enrollee have requested for Genotropin growth hormone therapy for treatment of his idiopathic short stature. Findings:  The physician reviewer found that the patient meets the FDA criteria of 2003 for growth hormone therapy. Because the patient has idiopathic short stature coupled with a gratifying growth response from growth hormone therapy, continued growth hormone therapy must be judged as a medical necessity in this instance.
Appeal type: Experimental/Investigational
Decision: Overturned

A 60-year-old female has requested approval for a positron emission tomography (PET) scan for evaluation of her breast cancer.    Findings:  Two physician reviewers found that the patient was found to have stage I left breast cancer nine months ago. She underwent a bilateral mastectomy. At surgery, axillary lymph node dissection on the left showed 7 of 15 positive lymph nodes. The patient had a PET/CT showing no hypermetabolic foci. No current physical or laboratory values reportedly indicate recurrence at this time. In light of the number of positive nodes and risk of recurrence or metastasis the provider has recommended a follow-up PET/CT.  The National Comprehensive Cancer Network (NCCN) guidelines offer wide latitude to clinicians who are concerned about early tumor recurrence of breast cancer based upon initial presentation, staging and biology of the tumor. The NCCN specify that PET/CT is indicated if tumor recurrence is considered likely. Although the original scan was negative, 7 of 15 axillary lymph nodes were positive at surgery. This ratio indicates the risk of recurrence is fairly high. So, in an effort to detect likely or highly possible tumor recurrence as early as possible to improve patient outcome, the use of PET/CT is the most accurate modality. By contrast, conventional imaging would not provide such advantages.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/ Case Summary:  The enrollee is requesting reimbursement for Zio Patch. The enrollee has a history of cerebrovascular accident (CVA), hypertension, and hyperlipidemia. The record indicates an emergency department (ED) visit with complaints of right-sided numbness to his face, feet, and fingers. The symptoms varied in intensity and had been present over three hours. He was significantly hypertensive in the ED. He was treated with clonidine, Lisinopril, and intravenous (IV) metoprolol. A computerized tomography (CT) scan of the brain showed no acute intracranial process. At a follow-up visit, he reported minimal numbness in the right side of his face; no weakness or facial droop. A magnetic resonance imaging (MRI) scan showed an acute left thalamic infarct and his physician scheduled a Zio Patch monitor to identify any significant arrhythmias. The fourteen day Zio Patch recording showed predominantly sinus rhythm with no episodes of atrial fibrillation. There was no AV block or significant pause. An echocardiogram demonstrated a left ventricular ejection fraction of 65%. There was mild, increased left ventricular wall thickness mild diastolic dysfunction. The valves were normal and there were no intra-cardiac sources of emboli identified. Review of the record indicates the enrollee experienced a cerebrovascular accident (CVA) which could be classified as cryptogenic. Cryptogenic ischemic strokes are symptomatic cerebral infarcts for which no probable cause is identified after adequate diagnostic evaluation. Investigation in enrollees with cryptogenic stroke typically includes evaluation for cardiac sources of embolism (structural and rhythm abnormalities). Atrial fibrillation may be asymptomatic. A work-up to rule out episodes of atrial fibrillation in an enrollee such as this one is medically necessary and standard practice. The medical literature shows positive results of the Zio Patch monitor in diagnosing episodes of atrial fibrillation. One study shows the substantial proportion of atrial fibrillation detection beyond the first 48 hours of monitoring which suggests the patch is superior to conventional 48 hour Holter monitors for the detection in enrollees with stroke or transient ischemic attack. Age >60 was a predictor of finding atrial fibrillation on prolonged monitoring. Final Result: The reviewer determined that the requested service is medically necessary for the treatment of the enrollees medical condition. Credentials/Qualifications: The physician reviewer is board certified in cardiology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or similar medical condition.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested inpatient chemical dependency services for treatment of his behavioral health conditions. Findings: The physician reviewer found that the documentation submitted for review does not support inpatient chemical dependency services. According to the documentation submitted, the patient has come to value the concept of treatment. He expressed motivation and willingness to engage services. He has access to specialty programming in the outpatient setting. In addition, the absence of significant co-morbidity supports a less restrictive setting. The patient had unremarkable mental status examinations. There was no evidence of withdrawal, suicidality, psychosis or bipolarity. Moreover, the patient had supportive family and had demonstrated the ability to achieve and maintain sobriety in the absence of a 24-hour treatment facility. Finally, the patient had no prior history of chemical dependency treatment in a less restrictive setting such as community programming, outpatient specialty care, intensive outpatient services or partial hospitalization. This is significant given that modern psychiatric practice favors treatment in the community as outcome measures and therapeutic gains are optimized in this environment. Also, there was no evidence to suggest that a less restrictive treatment setting would have been insufficient. Thus, the requested services are not medically necessary for treatment of the patients behavioral health conditions.Final Result: The reviewers determined that the requested services are not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: The physician reviewer is board certified in psychiatry and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Upheld

The patient is a five-year-old male with a diagnosis of DiGeorge syndrome with facial weakness on the right. He has had two heart surgeries. The patient has had a history of chronic otitis media requiring TM tubes; the tubes have been removed. He has documented hearing loss on the right. The patient has been receiving speech therapy since April 2004 secondary to speech production delays and expressive language delays. At issue is whether continued speech therapy is medically necessary for treatment of the patients condition.Review of the submitted clinical records demonstrates the therapist began seeing the patient in April 2004 with the goals of: increased expressive language, increased speech production, and parent and teacher education objectives for improved speech production. The stated goal of completion of five to seven oral motor exercises per week is a monitoring objective and does not require active therapy. The progress report also does not use objective findings to document the gains. Further, the stated goal of exhibiting improved motor planning does not use objective findings to demonstrate improvement. It simply states he continues to improve. Moreover, the progress report from January 2005 only states the objectives without providing any documentation the patient is achieving them, so it is unknown if the patient has been making progress toward goals.Based on the documentation provided, it has not been established that the patient requires or has benefited from speech therapy. Therefore, I have determined the requested therapy is not medically necessary for treatment of the patients medical condition. The Health Plans denial should be upheld.
Appeal type: Medical Necessity
Decision: Upheld

This is a 58-year-old female patient who has been on Humatrope injections since 2001. In addition she is taking Cozaar, Lexapro, sotalol, Protonix and the Vivelle patch.  In September 2001 she was found to have a low IGF-1 level of 47. She appears to have had two stimulation tests with L-Dopa and clonidine. There was no growth hormone stimulation with either test. Her thyroid panel was normal. ACTH, FSH and LH levels are not found in the submitted records.  The Health Plan denied authorization for growth hormone therapy based upon their determination that it is not medically necessary.The patient has a low IGF-I level and no other pituitary abnormalities. Clonidine and L-Dopa are the least reliable tests to stimulate growth hormone, and did not evoke a positive response in this patient.  Growth hormone therapy in an adult should not be initiated on the basis of a low IGF-1 level alone. If other pituitary hormone deficiencies can be demonstrated in addition to the lack of growth hormone stimulation with a more reliable stimulation test, the patients request for growth hormone should be reconsidered. Based upon the information set forth above, I have determined the requested therapy is not medically necessary for treatment of the patients medical condition. The Health Plans denial should be upheld.
Appeal type: Experimental/Investigational
Decision: Upheld

A 57-year-old female has requested transcranial magnetic stimulation (TMS) therapy for treatment of her depression.   Findings:  Two physician reviewers found that the patient presents with a 10-year history of depression. She has a diagnosis of major depressive disorder severe, recurrent. The provider states in a letter of appeal that the patients functionality is markedly impaired and her symptoms include withdrawal from her faith community, hopelessness, and suicidal ideation. The patients past treatments have included Zoloft, Prozac, Celexa, Lexapro, Effexor, Cymbalta, Remeron, and Buspar. Abilify and Zyprexa have been added on but reported as ineffective.Transcranial magnetic stimulation (TMS) was approved by the FDA in October 2008 for the treatment of patients with refractory depression. However, the American Psychiatric Association (APA) guidelines endorse electroconvulsive therapy (ECT) which remains the  most effective form of therapy and should be considered. Given the absence of any documented preexisting neurological or cognitive disorders, or any prior anesthetic related risks, this patient could be considered for ECT treatment. In addition, patients who have incomplete response to adequate trials of single treatment modalities may benefit from combined treatment with medication and a depression-focused psychotherapy. All told, TMS is not medically indicated at this juncture of treatment as the patients clinical needs could be met in a more intensive outpatient setting allowing her access to additional medication strategies as well as cognitive behavioral therapy (CBT). CBT does seem to have an enduring effect that protects against subsequent relapse and recurrence following the end of active treatment. Consistent with these findings, the requested TMS therapy is not likely to be more beneficial than standard therapies for treatment of this patients medical condition.
Appeal type: Medical Necessity
Decision: Upheld

The patient is 37-year-old female who has hand pain and limited mobility of her fingers. She has completed skilled physical therapy and is independent with a home education program. She has requested continued physical therapy for deep tissue massage with a physical therapist. The Health Plan has denied this request on the basis that the requested therapy is not medically necessary for treatment of the patients medical condition.Ongoing physical therapy is not medically necessary for the patient as she has already completed a course of physical therapy and is independent with a home education program. Further skilled physical therapy would be for the purpose of maintenance and is not likely to improve the patients condition or function in a reasonable or predictable time period. In addition, ongoing physical therapy for chronic massage therapy and other passive modalities is not medically warranted. Therefore, I have determined the requested therapy is not medically necessary for treatment of the patients medical condition. The Health Plans denial should be upheld.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Cimzia. Findings:  The physician reviewer found that the requested medication is medically necessary for treatment of the enrollees medical condition. Therefore, the Health Plans denial should be overturned.  Psoriasis is a chronic inflammatory skin disease. Enrollees with this condition typically present with sharply demarcated, inflammatory, erythematous plaques with characteristic silver-white scaling due to epidermal hyperproliferation and parakeratosis secondary to the inflammation. Psoriasis has a high negative impact on the quality of life. The long-term use of traditional systemic therapies is frequently unacceptable because of renal, hepatic and pulmonary toxicity as well as limited efficacy. Traditional systemic therapies for psoriasis, including methotrexate and cyclosporine, have a well-documented array of toxicities, particularly end-organ toxicities. Cimzia is a fragment crystallizable (Fc) free, pegylated, anti-tumor necrosis factor biologic that has demonstrated favorable results in ongoing, phase 3, randomized, double-blinded, placebo-controlled trials in adults with psoriasis. This enrollee has plaque psoriasis and psoriatic arthritis that affect the enrollee's quality of life. The enrollee did not respond to first-line anti-tumor necrosis factor therapy. Therefore, the enrollee requires an alternative anti-tumor necrosis factor treatment. Thus, Cimzia is medically necessary for the treatment of this enrollee.Final Result: The reviewer determined that the requested medication is medically necessary for treatment of the enrollees medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer is board certified in dermatology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.