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

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Epclusa for 12 weeks for treatment of the enrollees chronic hepatitis C virus (HCV) genotype 1a. Findings:  The physician reviewer found that according to the most recent 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. This recommendation applies to all patients, regardless of fibrosis stage. The guidelines recommend that treatment naive genotype 1a patients should be treated with regimens including Zepatier with ribavirin for 16 weeks when NS5A resistance is found, Harvoni for 12 weeks, or Epclusa for 12 weeks. In addition, treatment with Zepatier and ribavirin for 16 weeks was demonstrated to be 100% effective despite NS5A resistance in the phase III trial reported by Kwo and colleagues. This patient does not have a definitive medical contraindication to ribavirin, as there is no anemia, and thrombocytopenia was not reported as a side effect of ribavirin in a randomized controlled trial of ribavirin monotherapy. The AASLD/IDSA guidelines cite data showing reduced survival with delayed treatment. For these reasons, although treatment is needed, the request Epclusa for 12 weeks is not supported as medically necessary for the treatment of this patients hepatitis C infection as Zepatier is available within the Health Plans formulary. 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 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:   An enrollee has requested Harvoni 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. This applies regardless of fibrosis stage or viral load, and advanced fibrosis is not required for treatment. Per guidelines, treatment-naive genotype 1 patients should be treated with Harvoni. Patients with viral load of less than 6,000,000 IU/mL can be treated for eight weeks. These guideline recommendations are based on multiple randomized clinical trials (Kowdley, et al; Afdhal, et al). AASLD/IDSA guidelines cite data showing reduced survival with delayed treatment (Jezequel, et al). For these reasons, the requested treatment with Harvoni is medically necessary for the treatment of this patients hepatitis C infection. Final Result: The reviewer determined that the requested medication 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: Experimental/Investigational
Decision: Upheld

A 48-year-old female enrollee has requested InTone therapy (pelvic floor stimulation device  E0740) for treatment of her urinary stress incontinence.  Findings:  Three physician reviewers found that the medical literature does not support the efficacy and safety of the requested InTone therapy pelvic floor stimulation device. There are limited data demonstrating short-term improvements. However, the evidence does not indicate that the requested device is superior to standard interventions. Further, this patients records do not document that the patient has been treated with any first-line therapies prior to consideration of the InTone therapy. Given the lack of current literature supporting the clinical effectiveness of the InTone therapy (pelvic floor stimulation device  E0740), the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Orthovisc injections in the right knee (J7324). Per the medical literature, although viscosupplementation may relieve knee pain in some individuals with osteoarthritis, it is not known as to which individuals will benefit. The current evidence is limited, and guidelines from organizations such as the American Academy of Orthopedic Surgeons indicate that the evidence is not conclusive. In light of the foregoing, viscosupplementation can only be recommended in individuals with a history of lasting benefit from prior injections, and in carefully selected cases where everything else has been tried, and the options are limited. In this case, the patient has a history of advanced osteoarthritis of the right knee and recurrent pain. The records show that the patient has a history of excellent response with viscosupplementation, with relief lasting as long as nine months. The patient has tried and failed other conservative treatments, with the alternative being a total knee arthroplasty. Given the patients limited options and based on the current medical literature, the requested services are medically indicated. Therefore, Orthovisc injections in the right knee (J7324) are medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested services are 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 orthopedic surgery 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

A 58-year-old male enrollee has requested physical therapy (PT) for treatment of lower extremity pain.  Findings:  The physician reviewer found that the physical therapist provided comprehensive evaluations at regular and reasonable intervals. Functional deficits, short and long-term goals and expected outcomes were identified in each instance. Plans of care were reviewed and signed by the patients physician. The patients medical condition evolved over the course of his PT and services from a less skilled provider would have been inadequate. He was consistent with his treatment and showed improvement within a reasonable timeframe.
Appeal type: Medical Necessity
Decision: Upheld

The parents of an 11-year-old male enrollee have requested for growth hormone therapy for treatment of the enrollees idiopathic short stature. Findings:  The physician reviewer found that his current growth rate is not documented in the medical records provided. The records also lack documentation that a pediatric endocrinologist is actively involved with this patients care, which is one of the recommended criteria for the use of growth hormone therapy for treatment of idiopathic short stature. All told, there is inadequate information demonstrating that this patient meets medical necessity criteria for growth hormone therapy at this time.
Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Radicava for treatment of the enrollees amyotrophic lateral sclerosis (ALS). Findings:  Three physician reviewers found that Radicava has had several double blinded clinical trials. A phase 3 trial was positive leading the U.S. Food and Drug Administration (FDA) approval of the drug for the treatment of ALS. The FDA did not specify when in the disease course the treatment was indicated. Although the initial phase 3 study with more advanced patients did not meet the primary endpoint, there was statistically insignificant slowing of disease progression in the study group. In this case, the patient has ALS that is between early and late stage disease. Given the clinical documentation submitted for review, treatment with Radicava is likely to be more beneficial for treatment of the patients ALS than any available standard therapy. Final Result: The reviewers determined that the requested medication is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: Reviewers 1, 2 and 3 are board certified in neurology and are actively practicing. The reviewers are experts 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

A 57-year-old male enrollee has requested for Lyrica for treatment of his peripheral neuropathy. Findings:  The physician reviewer found that while Lyrica is specifically approved for painful diabetic neuropathy, it is also useful for a number of different painful neuropathies. Furthermore, the patient has tried and failed other available medications. Treatment with Lyrica is appropriate, safe and effective for this patient.
Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary:  An enrollee has requested testing of serum concentration of infliximab and antibodies to infliximab for evaluation of his medical condition.  Three physician reviewers found that the current medical evidence has not established the superior efficacy of the services at issue.  Monitoring patients on infliximab with measurement of infliximab levels and antibodies to infliximab continues to be an area of intense investigation.  In general, infliximab levels correlate inversely with disease activity.  However, the target level of infliximab necessary to achieve clinical benefit remains unknown.  There is a lack of controlled data which have identified the optimal drug level.  All told, testing of serum concentration of infliximab and antibodies to infliximab was not likely to have been superior over other methods of evaluation. Final Result: Three 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: All three reviewers are board certified in internal medicine with sub-specialty certification in gastroenterology and are actively practicing. All three reviewers are experts 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

A 58-year-old male enrollee has requested for administration of Procrit for treatment of his esophageal cancer. Findings:  The physician reviewer found that Procrit use is appropriate for chronic anemia due to cancer if the hemoglobin is closely monitored. Procrit can improve quality of life. However, in this patients case, the medical necessity of the medication at issue has not been established by the submitted documentation
Appeal type: Medical Necessity
Decision: Overturned

A 47-year-old female enrollee has requested a medication regimen of Rocephin for the treatment of her Lyme disease. Findings:  The physician reviewer found that the patient may have late stage Lyme disease. As such, treatment with IV Rocephin was appropriate, but not in the dose or for the period indicated. Treatment regimens of doses higher than two gm per day or regimens longer than 30 days are not supported by the literature. There are no scientific, peer-reviewed studies that demonstrate the efficacy of extended antibiotic therapy. A treatment regimen of IV Rocephin not to exceed 2 gm per day for 30 days was medically necessary for this patient. Any use of Rocephin in excess of this was not clinically indicated.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested fentanyl patches for treatment of the enrollees post-laminectomy syndrome.  Findings: The physician reviewer found that based on the current medical literature and the presented clinical records, fentanyl patches are not medically necessary for treatment of the patients medical condition. The current standard of care for chronic pain associated with post-laminectomy is treatment in a multidisciplinary practice that includes physical therapy, massage therapy, behavioral therapy, and steroid injections. According to Mafi and colleagues Well-established guidelines for routine back pain stress conservative management including use of non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen, and physical therapy, but avoiding early imaging or other aggressive treatments except in rare cases such as those demonstrating acute neurological compromise or other red flags such as a history of malignancy. In addition, Karppinen and colleagues state that Conservative decisions in the treatment of degenerative disk disease are based on interventions made for patients with chronic [lower back pain] LBP. There is convincing evidence that patient education, exercise therapy, and cognitive behavioral therapy are the cornerstones for the treatment of chronic LBP. Moreover, high dose opioids are associated with a high risk of dependence. Therefore, the request for fentanyl patches is not medically necessary for treatment of the patients medical condition.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: Upheld

Nature of Statutory Criteria/Case Summary:  An enrollee has requested full body computed tomography (CT) or full body magnetic resonance imaging (MRI) for evaluation of his peripheral neuropathy. The physician reviewer found that the submitted documentation fails to establish the medical necessity of the requested services. There is no medical literature that addresses medical necessity or lack of medical necessity, for whole body MRI or CT scan for the evaluation of numbness. Numbness can be caused by disorders of the peripheral nerves, nerve roots, spinal cord or brain. The evaluation of numbness is dictated, initially, by the patients symptoms and findings on examination. If disorders of the peripheral nerves or nerve roots are suspected appropriate, evaluation would include electrodiagnostic studies and nerve conduction studies, laboratory evaluation and focused imaging studies, typically MRI. The latter are used to evaluate possible nerve or nerve root impingement based on the results of the clinical examination and electrodiagnostic studies. If the patients symptoms and physical findings suggest sensory loss as a result of a disorder of the brain or spinal cord, MRI studies of these parts of the nervous system are appropriate. In general, CT scanning of the nervous system is less likely to demonstrate any cause for numbness or sensory loss than MRI. In addition, whole body CT scanning involves significant exposure to ionizing radiation. In this case, electrodiagnostic evaluation and/or a lumbar MRI as recommended by his treating providers are medically reasonable and appropriate. Thus, the requested services are not medically necessary for evaluation of the patients medical condition.  Final Result: The reviewer determined that the requested services are not medically necessary for evaluation of the patients medical condition. Therefore, the Health Plans denial should be upheld.  Credentials/Qualifications: The reviewer is board certified in neurology 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 parent of a two-year-old female enrollee has requested  for group speech therapy for treatment of the enrollees mixed receptive-expressive language disorder. Findings:  The physician reviewer found that Nelson and colleagues, speech and language development is considered by experts to be a useful indicator of a childs overall development and cognitive ability and is related to school success.  The authors reported that identification of children at risk for developmental delay or related problems may lead to intervention services and family assistance at a young age when chances for improvement are best.  Per the current medical evidence, speech and language delay must be taken seriously in young children, because the long-term consequences may be substantial.  As noted by Law and colleagues, approximately 6% of children have speech and language difficulties.  The authors noted that children whose difficulties persist into primary school may have long-term problems concerning literacy, socialization, behavior, and school attainment.  Bernhardt and Major concluded that early phonological and metaphonological intervention can promote normalization of speech development and normal acquisition of literacy skills for some children with a history of severe phonological impairment.  This patient demonstrates mixed receptive and expressive language delay as well as articulation difficulties that are negatively impacting her ability to communicate in a functional and age-appropriate manner.  Studies have shown that speech and language therapy can result in significant improvement in this clinical setting.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage of Zepatier for treatment of the enrollees hepatitis C virus. Findings:  The physician reviewer found that according to the most recent 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. This recommendation applies to all patients, regardless of fibrosis stage. The guidelines recommend that treatment naive genotype 1a patients should be treated with regimens including Zepatier when NS5A resistance is not found, and Zepatier with ribavirin when NS5A resistance is present. These guideline recommendations are based on clinical trial results showing a 58% cure rate with Zepatier when NS5A resistance is present. When NS5A resistance is present, Zepatier and ribavirin is recommended by the guidelines, based on a 100% cure rate in the C-EDGE TE trial.  In this case, as NS5A resistance testing results are not provided, it is impossible to determine whether the requested regimen is appropriate. AASLD/IDSA guidelines cite data showing reduced survival with delayed treatment. For these reasons, although treatment is needed regardless of fibrosis stage, the request for Zepatier is not supported as medically necessary for the treatment of this patients hepatitis C infection.  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 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: Upheld

A forty-seven year-old male with a history of major depression and attention deficit hyperactivity disorder is requesting authorization Provigil.  The submitted records do not document a trial of Strattera, Ritalin or amphetamines.Reviewers Findings:  The reviewing physician found that the submitted clinical information does not demonstrate the patient meets medical necessity criteria for Provigil. There are other medications that can be utilized in this case including Ritalin and/or amphetamines.  The reviewing physician found that the Health Plan denial should be upheld.
Appeal type: Medical Necessity
Decision: Upheld

The parents of a seven year-old female with short stature are requesting authorization for growth hormone therapy.Reviewers Findings:The reviewing physician found that the patient does not appear to have GH deficiency, nor is there evidence of intra-uterine growth retardation with failure to catch up.  The physician concluded that the Health Plan denial should be upheld.
Appeal type: Medical Necessity
Decision: Overturned

The parents of a five-year-old male enrollee have requested for speech therapy for treatment of the enrollees autism. Findings:  The physician reviewer found that the reports of the child clearly establish and reinforce a diagnosis of autistic spectrum. The etiology of autism has not been clearly delineated, but the consensus is that it is a congenital disorder. The highlight of dysfunction in autism is a communication defect. Consistent speech therapy on a one-to-one basis is the only known method of improving communications in an autistic child.The speech therapy reports have clearly defined goals on each visit. Generally, the trend is consistent improvement in these goals. The variation in the sub-tests of the psychometric testing is consistent with a child with autism, despite the childs improvement.
Appeal type: Experimental/Investigational
Decision: Upheld

A 50-year-old male has requested Avastin for treatment of metastatic melanoma.  Findings:  Two physician reviewers found that the use of Avastin in metastatic melanoma is currently being studied as a single agent, and in combination with other agents in several early phase two studies. Thus, the use of Avastin for metastatic melanoma is experimental/investigational in nature. The FDA has not approved Avastin for treatment of the patients condition. There is no compendium listing for Avastin for metastatic melanoma. Furthermore, there have been no randomized control trials evaluating the efficacy of Avastin alone in this setting. Finally, Avastin is not accepted by major medical bodies as being appropriate treatment for this indication.