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

The patient is a 58-year-old male with organic erectile dysfunction on a vascular basis due to arteriosclerosis, diabetes mellitus and hypercholesterolemia.  According to the December 2005 urology report, he is taking Nitrostat, a nitroglycerin preparation.  The patients previous treatment with Viagra, an oral PDE-5 inhibiting medication, was unsuccessful as was treatment with Caverject intra-cavernosal injection therapy.  Surgical treatment with the placement of a multi-component penile prosthesis has been recommended by his urologist. The Health Plan denied authorization for this procedure based upon a determination that it is not medically necessary.The medical records presented indicate that this patient has erectile dysfunction on an organic basis, due to diabetes mellitus and vascular disease. Three worthwhile alternative treatments are available to him, and should be tried in the order of presentation.  Typically, first line treatment is with oral PDE-5 inhibiting medications such as Viagra, Levitra and Cialis. The record did not include the details of this treatment with Viagra and the patient has not yet tried Levitra or Cialis. In this case, the medical records submitted document treatment with Nitrostat for his arteriosclerotic cardiovascular disease, therefore treatment with oral PDE-5 inhibiting medications is contraindicated and not a viable treatment option. The second treatment option is intra-cavernosal injection therapy. The record indicates the patient tried Caverject without a good response.  However, the record did not indicate when or how many times this medication has been used, nor is there a reference to the dosage of medication used.  The dosage range is from 2.5mcg to 60mcg, or more, and the response tends to be dose related. There is no evidence the patient has been treated with the Tri-mix combination injections.  The appropriate next step in the treatment of his erectile dysfunction would be an adequate trial of intra-cavernosal injection therapy - adequate dosages of either Caverject or Tri-mix, or both, providing he is able to carry out and tolerate the injections. If all non-operative treatments fail, surgical treatment such as placement of a penile prosthesis device is appropriate.  It involves all the risks of surgery and anesthesia, may be complicated by infection, may require further surgeries to correct problems and/or to remove the device, and will forever alter the appearance of the penis. That is why non-operative options should be fully exhausted before the surgery is undertaken, and that has not yet been done.  Based upon the information set forth above, I have determined the requested procedure is not medically necessary for treatment of the patients medical condition. The Health Plans denial should be upheld.
Appeal type: Experimental/Investigational
Decision: Overturned

The parent of a one-year-old female enrollee has requested a cranial orthosis (helmet) for treatment of the enrollees plagiocephaly. Findings:  Three physician reviewers found that Teichgraeber and colleagues studied 248 infants who were treated for posterior positional plagiocephaly. They found that molding helmet therapy is an effective treatment for position-induced head shape abnormalities. According to Vles and colleagues, helmet therapy produces a significantly faster response when compared to non-helmet treatment. In 2003, the American Academy of Pediatrics concluded that the best response for helmets occurs in the age range of 4 to 12 months due to the greater malleability of the infant skull bone and the normalizing effect of the rapid growth of the brain. There is less modification of the cranial configuration when used after 12 months of age. According to Persing and colleagues, the use of helmets and other related devices may be beneficial when there has been a lack of response to mechanical adjustments and exercises.  All told, the cranial orthosis (helmet) is likely to be the most beneficial treatment alternative for this patient.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage of Harvoni 90/400 mg tablets for 12 weeks for treatment of the enrollees hepatitis C infection. 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. 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 (FDA) 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: Urgent Care
Decision: Upheld

The parent of a 17-year-old female enrollee has requested psychiatric emergency services for evaluation of the enrollee's medical condition.  Findings:  The physician reviewer found the submitted clinical documentation fails to demonstrate that the patient had a psychiatric emergency medical condition that required the services at issue on an emergent basis. Upon the patients discharge from inpatient level of care, the patient was noted to be stable and improved, with no suicidal ideation, thought, intent, or plan.  A psychiatric emergency medical condition is defined as a disorder that manifests itself by acute symptoms of sufficient severity that it renders the patient as being either of the following: an immediate danger to himself or herself or to others, or immediately unable to provide for, or utilize food, shelter or clothing due to the mental disorder. There is no evidence that the patient posed a risk to others during the period at issue. Further, the patient was noted to be stable and was without suicidal ideation or plan. The submitted clinical records do not demonstrate that the patient was unable to attend to her daily needs. Given that the patient did not meet the above-described definition of a psychiatric emergency medical condition, the services at issue were not required on an emergent basis.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for a nasal valve support. Based on the available documentation and physical examination findings, this patient does not meet the current criteria for consideration of placement of the requested device. Specifically, there is no documentation provided that shows that the patients nasal airway is obstructed or blocked. In addition, the CT scan did not demonstrate any significant deformity of the nasal septum, but rather showed open, clear sinuses. In this clinical case, there is no documentation provided that anatomical issues need to be corrected. For these reasons, the requested nasal valve support is not medically necessary for treatment of this patients medical condition. Final Result: The reviewer determined that the requested device 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 otolaryngology 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: Overturned

A 42-year-old male enrollee has requested a laparoscopic sleeve gastrectomy for the treatment of his morbid obesity. Findings:  Two physician reviewers found that sleeve gastrectomy as part of a staged procedure is the most appropriate option for this patient. In a super morbidly obese patient, a standalone malabsorptive procedure such as Roux-en-Y gastric bypass and duodenal switch are more difficult to perform and carry greater risk. Furthermore, a lap band procedure involves less weight loss and will not achieve adequate results as a standalone procedure. Nor is it easily converted to a second procedure, as a gastric resection has to be done. For patients with sleeve gastrectomy, gastric resection has already been performed prior to the second surgery. All told, laparoscopic sleeve gastrectomy as the first stage of a two-phase surgery is likely to be superior to any other bariatric procedure.
Appeal type: Medical Necessity
Decision: Upheld

A 59-year-old male enrollee requested authorization and coverage of continued occupational therapy to assist recovery following a stroke. The health plan denied the request indicating that the requested therapy is not medically necessary.One physician reviewer performed a medical necessity Independent Medical Review. The physician reviewer upheld the health plans denial on the basis that the requested services are not medically necessary.
Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested a diagnostic test with a wireless capsule endoscopy for evaluation of her Celiac disease (CD). Findings:  Two physician reviewers found that according to the American College of Gastroenterology guidelines, a capsule endoscopy should not be used for an initial diagnosis except for patients with positive celiac sprue serology who are unwilling to undergo upper endoscopy and biopsy. The diagnosis is confirmed by duodenal mucosal biopsies. The sensitivity of capsule endoscopy is less when there is partial villous atrophy and all non-atrophic lesions (Marsh III) may elude visual detection. The capsule endoscopy should be reserved for the patients with complicated CD, such as patients with refractory CD and persistent diarrhea, abdominal pain, weight loss and hypoalbuminemia. In this case, the patient has been doing well on gluten-free diet, and has no pain and diarrhea, and no clinical evidence of refractory CD.  Given the above, the wireless capsule endoscopy is not supported by the clinical documentation provided for review.Final Result: Two reviewers determined that the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: Reviewers 1, 2, and 3 are board certified 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: Overturned

Nature of Statutory Criteria/Case Summary: The patient has requested reimbursement for the inpatient behavioral health level of care services for treatment of the enrollees behavioral health issues. Findings:  The physician reviewer found that This patient had a formidable psychiatric history characterized by affective illness, anxiety with somatic features, cognitive decline and substance use. Upon presentation, she was anxious, disorganized and unable to attend to her activities of daily living. She had history of non-adherence with treatment and a recent acute hospitalization. As such, treatment in a less restrictive setting at the time would have been inadequate while hospital-based care was reasonably expected to improve the patients condition and prevent a more serious condition. Further, the admission served the purpose of refining the patients diagnostic assessment. However, based on the medical records, the services at the acute inpatient setting were no longer necessary . The patients mood stabilizer was changed from aripiprazole to olanzapine and she was continued on sertraline and gabapentin for mood and anxiety. Trazodone for sleep was discontinued but reinstated a few days later. The patient was anxious in both mood and affect. However, she had no suicidal ideation or hallucinations. Her intellect and memory were normal. She was eating meals and sleeping well. She was not disruptive on the unit. The diagnostic assessment was generalized anxiety disorder.  The patients diagnosis was changed to bipolar disorder. She was adherent with her medications which had not been changed since admission. She slept seven hours at night, and her mood remained anxious but her affect was brighter.  The patient made good eye contact, she was interacting with peers, and she was not confused. She was actively engaged in treatment. She had a supportive sister and male friend. Although ongoing care was indicated, there was no evidence of an acute psychiatric syndrome or that service delivery in a less restrictive setting would have been unsafe or inadequate. As such, inpatient behavioral health level of care services were medically necessary but not thereafter. Final Result: The reviewer determined that a portion of the services at issue were medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be partially overturned.Credentials/Qualifications: The 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: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for obinutuzumab (Gazyva) therapy for treatment of the enrollees end stage renal disease (ESRD) secondary to C1q nephropathy. Findings:  Three physician reviewers found that an alternative to murine anti-CD20 antibody is justified by this patients side effects to treatment with rituximab. Humanized anti-CD20 has been used in antibody mediated rejection by the same transplant team and their experience has been published. Since the patients providers have recommended against another round of rituximab and he faces possible organ failure, treatment with Gazyva is likely to be more beneficial for treatment of the patients medical condition 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: All three physician reviewers are board certified in nephrology and re 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: Upheld

The patient is a 61-year-old woman with extensive, severe psoriasis with itching. The patient has been on Soriatane and received PUVA phototherapy from July 2003 to December 2003. The patient states that prior to PUVA therapy, she scratched her lesions because of severe itching with resultant open sores. The patient reports that during PUVA therapy, the itching and extent of her psoriasis improved markedly. The Health Plan has denied authorization and coverage for additional PUVA therapy on the basis that the requested therapy did not improve the patients psoriasis. The patient indicates that her condition improved considerably since she began receiving PUVA therapy and she has submitted copies of photographs in support of this contention. However, the submitted dermatology notes do not document whether the patients psoriasis has improved. While the dermatology notes address the areas of involvement, the extent of involvement is not documented. Therefore, I have determined that the requested therapy is not medically indicated at this time. The Health Plans denial should be upheld at this time. However, if the patients dermatologist provides documentation that PUVA therapy has resulted in improvement in the severity of the patients psoriasis, additional PUVA therapy should be authorized.
Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for transcranial magnetic stimulation (TMS). Findings:  Three physician reviewers found that the services in issue were likely to be more beneficial for treatment of the patients medical condition than any other available standard therapy. The patient had received approximately 36 TMS treatments prior to receiving the services in issue. The Health Plan stated that additional TMS sessions, beyond 36 sessions, is investigational. The exact number of TMS treatments needed for successful depression symptom resolution, however, is not clearly defined in the evidence based literature. It does appear that certain patients need more than 30 treatments to come to successful resolution of their symptoms. The optimal TMS protocol remains unclear. Due to the fact that there are no hard and fast guidelines for the exact number of necessary TMS treatment sessions, and the fact that many patients respond slightly or drastically different to TMS, it appears that the number of sessions often needs to be considered on a clinical basis instead of a numerical basis. In this case, the patient was treated with very close to the current recommendation of approximately 30 sessions. It appears that the patient was tolerating treatment well and that the eventual sessions administered during the period in issue were more effective for him. The patients number for treatment sessions was not drastically outside of the loose recommendations for TMS, and the evidence base is unclear on the exact number recommended treatments. Therefore, the transcranial magnetic stimulation (TMS) received was likely to be more beneficial for treatment of the patient's condition than any other available standard therapy.Final Result: The reviewers determined that the services in issue were likely to be more beneficial for treatment of the patients medical condition than any other available standard therapy. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: All three physician reviewers are board certified in psychiatry 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: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested Foundation One gene testing for evaluation of the enrollee's pigmented villonodular synovitis (PVNS). Findings:  Three reviewers found that PVNS is a rare disease which results in proliferation of the synovial tissue. It is a result of hypervascular proliferative synovium containing multi-nucleated giant cells, macrophages, and hemosiderin. Since the giant cells express osteoclasts, the abnormal proliferation of the synovial tissue results in destruction of adjacent bone. The optimal treatment option is surgical resection but there is a high risk of recurrence. Since PVNS is a rare disease treatment options are in limited. Due to the high risk of recurrence, radiation therapy is also considered a treatment option and is associated with a decrease in the rate of recurrence. Due to the patients sub-optimal results with radiation and surgery, novel therapeutic options were evaluated. A translocation of the colony stimulating factor 1 (CSF1)-COL6A3, t(1;2)(p13;q35) is associated with overexpression of CSF1 gene and results in CSF1 receptor (CSF1R) and recruitment of CSF1R-expressing cells of the mononuclear phagocyte lineage that make up the tumor mass of PVNS. A phase I/II and II study demonstrated that PLX3397 is an active CSF1R inhibitor in tumors expressing elevated levels of the CSF1 gene. These studies demonstrated a response rate of 25%. Given the patients sub-optimal results with radiation and surgery, the Foundation One gene testing was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Final Result: The reviewers determined that the testing at issue was likely to be more beneficial for evaluation 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 internal medicine with sub-specialty certification in medical oncology and is 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: Upheld

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Elmiron capsules. Recent studies, questions have been raised about the efficacy of oral pentosan polysulfate (PPS) for the treatment of bladder pain syndrome and interstitial cystitis. The author found that while oral PPS remains a useful pharmacological agent, it may be effective only in a subgroup of patients.  The U.S. Food and Drug Administration approves the use of Elmiron for the treatment of relief of bladder pain or discomfort associated with interstitial cystitis at a recommended dosage of 300 mg daily, divided into three 100 mg capsules. Given a lack of evidence in current medical literature that dose escalation increases the efficacy of this medication, the requested medication regimen is not medically indicated. The Health Plans quantity limit of 90 capsules per month is medically appropriate. Therefore, Elmiron capsules are not medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested medication regimen 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 urology 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.