Persius/imr-appeals huggingface dataset:
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2

A 32-year-old male enrollee has requested authorization and coverage for Gammagard liquid (immune globulin (human) IV or subcutaneous solution 5 gm/50 ml and Gamunex-C. The Health Insurer has denied this request and reported that the medication at issue is investigational for the treatment of the enrollees medical condition. The physician reviewer found that the medical evidence supports the requested medication in this patients case. The records document peripheral motor neuropathy, which is consistent with chronic inflammatory demyelinating polyneuropathy. Chronic inflammatory demyelinating polyradiculoneuropathy is a heterogeneous disorder that includes diverse clinical presentations and immunopathological mechanisms. Intravenous immune globulin is currently the standard of care in the treatment of patients with this condition. This patient is likely to benefit from intravenous immune globulin over other treatments. In sum, Gammagard liquid (immune globulin (human) IV or subcutaneous solution 5 gm/50 mL) and Gamunex-C is likely to be more beneficial than other treatment options.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 

The parent of an 11-year-old male enrollee has requested authorization and coverage for orthoptic and pleoptic training. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested services. The patients optometric record carries no diagnosis of ocular pathology, only the functional diagnosis of convergence excess. There is no documentation provided of any illness, injury, or significant organic malfunctioning of the patients eyes. The providers letter indicates that the patient has several psychological disorders. There is insufficient evidence supporting the medical efficacy of the requested orthoptic and/or pleoptic training. Per the American Academy of Ophthalmology, there is a lack of evidence-based information supporting the effectiveness of vision therapy. Vision therapy is not within the standard of medical care for children with reading difficulties, attention problems, or other psychological disorders. Therefore, the requested orthoptic and/or pleoptic training is not medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 


A 39-year-old male enrollee has requested reimbursement for inpatient services from 4/30/17 through 5/4/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees dermatofibrosarcoma protuberans (DFSP) of the left shoulder. The physician reviewer found that the optimal outcome for application of a split thickness skin graft to a wound is 100% engraftment. Multiple studies have shown that the application of a wound VAC facilitates the skin graft take, thereby reducing the incidence of graft loss and the subsequent events of: 1) potential infection, 2) additional wound care, 3) possible repeated operations to apply additional skin grafts. In addition, immobilization of the engrafted area reduces shear forces and increases the rate and overall percentage of successful skin grafts. While VAC therapy can be used in the outpatient setting, given the irregular contour of the shoulder and the ongoing need to assess and maintain the negative pressure to ensure optimal function of the VAC device, inpatient care is the optimal setting for continuous VAC device use. Therefore, given the location of the tissue defect on the left shoulder and the inherent immobility required, as well as the indicated use of a wound VAC, inpatient care for the provision of these services was medically indicated. Therefore, the inpatient services provided from 4/30/17 through 5/4/17 were medically necessary for the treatment of this patients medical condition. In sum, based on the reasons stated above, the services at issue were medically necessary for the treatment of this patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

The parent of a 15-year-old female enrollee has requested authorization and coverage for Focalin XR 25mg, 1 capsule every morning. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees attention deficit disorder (ADD) without hyperactivity.   The physician reviewer found in a study by Borgheini, brand name medications had a higher bioavailability than generic medication. This same study also indicated that illness recurred quite readily after brand was switched to generic. Desmarais and colleagues in a review article citing studies from 1974 through 2010 raise concern about the efficacy of generic drugs versus their brand equivalents, suggesting that amount of active ingredients in the generic was quite different than similarly dosed brand names. These studies indicate that use of generic medications may lead to higher dosing requirements and may lead to relapse of symptoms or need for more intensive services. Medical guidelines generally recommend change in medication after two to three failed medication trials.  In this is a case, Adderall XR, Concerta and Metadate CD and Vyvanse were tried and failed in some significant way. While there may be other products on the market with similar ingredients, medical studies have shown that some individual patients may respond better to one product over another. Upon review of this patients submitted medical records, this appears to be one of those cases. Therefore, the requested Focalin XR is medically necessary for treatment of the patients medical condition.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2

A 44-year-old male has requested authorization and coverage for total disc arthroplasty at the levels of L4-L5 and L5-S1. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that the Single-level lumbar disc replacement was U.S. Food and Drug Administration (FDA) approved in 2006 with the ProDisc-L based on good mid to long-term studies. The FDA approved the first two-level lumbar disc replacement in 2020, again with ProDisc-L implant showing good results. The study by Rasouli and colleagues involved a cohort of 159 patients. The authors concluded, aMultilevel total disc replacement preserves range of motion at the individual total disc replacement levels. Most significantly, the non-operative adjacent level maintains its preoperative range of motion at two to six years postoperatively. At up to six years of follow-up, there has been no need for revision or adjacent-segment surgery. Patients also demonstrate significant improvement in pain and disability at latest follow-up.a In a clinical case series involving 122 patients by Scott-Young and colleagues, multilevel total disc replacement for multilevel degenerative disc disease demonstrated favorable and sustained clinical outcomes at mid-term to long-term follow-up. In a comparison of a two-level versus one-level total disc replacement by Zigler and Ohnmeiss, patients undergoing two-level total disc replacement improved significantly postoperatively based on visual analog scales and Oswestry scores, and there were no significant differences in outcome scores when comparing one- and two-level total disc replacement. In sum, there is sufficient support for the requested services in this clinical setting. Therefore, total disc arthroplasty at the levels of L4-L5 and L5-S1 is likely to be more beneficial than any available standard therapy.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3

A 65-year-old male enrollee has requested reimbursement for gene testing provided on 9/26/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that Melanoma is a cancer that is curable in its earliest stages. Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76-1.0 mm. Metastases to regional lymph nodes may be amenable to excision, but this suggests a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha. The data on DecisionDx-Melanoma has not made it part of routine analysis after sentinel lymph node biopsy. There has also been some lack of consistency between various genes being used as biomarkers. As such, the test is novel, and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. Thus, gene testing provided on 9/26/18 was not likely to have been of greater benefit than other methods of evaluating this patient.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

The parent of a 16-year-old transgender male enrollee has requested authorization and coverage for 19350 (nipple/areola reconstruction). The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees gender dysphoria. The physician reviewer found that chest surgery for transmasculine youth is a common intervention for gender dysphoria. There is no justification for limiting coverage for treatment to adults. The World Professional Association for Transgender Health (WPATH) notes that chest surgery in transgender males could be carried out earlier [than age 18], preferably after ample time of living in the desired gender role and after one year of testosterone treatment. In this case, the patient has had ample time living as male and is on testosterone. Chest surgery is a safe and effective treatment for gender dysphoria in transmasculine youth. Olson-Kennedy and colleagues stated, Chest dysphoria was high among transmasculine youth, and surgical intervention positively affected both youth and adults. The current medical evidence supports the requested services in this patients case. Therefore, 19350 (nipple/areola reconstruction) is medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1


A 25-year-old female has requested authorization and coverage for intravenous ceftriaxone.  The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees medical condition. The physician reviewer found there is a lack of support for the requested medication in this clinical setting.  There is a lack of evidence that this patient has any infection.  The records do not describe a tick bite or the development of a rash at the site of the bite.  Her symptoms are non-specific.  There is also no evidence for either Babesia or Brucella infection. One month of ceftriaxone is accepted therapy for Borrelia infection if cardiac disease is present, neurological involvement is documented or joint involvement is found.  In this case, none of these forms of infection is present.  The notes state she is being treated for neurological infection, but there is no evidence to support this diagnosis.  The current medical evidence has not demonstrated that greater than 28 days of therapy is of benefit for patients with Lyme disease, and the records do not demonstrate that she has Lyme disease.  In sum, intravenous ceftriaxone is not likely to be superior over other treatment options.  Based upon the information set forth above, the requested medication is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1 
 
A 24-year-old female enrollee has requested authorization and coverage for lower esophageal 
myotomy, transoral (peroral endoscopic myotomy) (POEM) and one inpatient day. The Health 
Plan has denied this request indicating that the requested service is investigational for the 
treatment of the enrollees medical condition. The physician reviewer found  that there is 
sufficient  support  for  the  requested  service  in  this  clinical  setting.  The  American 
Gastroenterological Association best-practice guideline states that if the expertise is available, 
POEM should be considered as treatment option comparable with laparoscopic Heller myotomy 
for any of the achalasia syndromes. The American Society for Gastrointestinal Endoscopy has 
recently published a statement based on available evidence, stating that POEM is a potential 
attractive option for the treatment of achalasia that offers a minimally invasive endoscopic 
approach to myotomy with the potential for a durable response to therapy. Clinical studies and 
trials  have  shown  comparable  efficacy  with  surgery  when  expertise  in  POEM  is  available. 
However,  despite  comparable  efficacy,  POEM  is  significantly  less  invasive  than  surgical 
intervention, resulting in less postoperative pain and a more rapid recovery. In this patient with 
symptoms including dysphagia and regurgitation, as well as failure of pneumatic dilation, the use 
of POEM is supported by current medical literature and guidelines. Therefore, lower esophageal 
myotomy, transoral POEM and one inpatient day is likely to be more beneficial than any available 
standard therapy.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

The patient is a 58-year-old female with a history of acromegaly. She underwent a transsphenoidal resection of a pituitary mass in 2005, followed by radiation therapy. The physician reviewer found that the acromegaly is a chronic, progressive, and potentially lethal disease caused by a growth hormone (GH) secreting pituitary adenoma and resultant excess in circulating levels of GH and insulin-like growth factor-1 (IGF-1). Transsphenoidal pituitary adenoma resection is generally the first-line therapy for acromegaly. Pharmacologic agents available for treatment of persistent acromegaly include somatostatin-receptor ligands, GH-receptor antagonists and, in selected cases, dopamine agonists. Somatostatin receptor ligands, such as Sandostatin LAR, are considered the mainstay in the medical management of acromegaly. However, this agent requires deep tissue injection and can be associated with substantial treatment burden or deleterious long-term sequelae, including injection site pain, nodules, bruising, inflammation, and scarring. Injectable somatostatin receptor ligands may also negatively affect patient quality of life; patients have reported anxiety, frustration, and loss of independence caused by the injections. Accordingly, oral octreotide capsules (OOCs), such as Mycapssa, were developed as a potential treatment option to address challenges encountered with injectable medications. Recent data suggests that maintenance of mean IGF-1 levels for the OOC group from baseline to end of treatment indicates that patients who switched from injectable somatostatin receptor ligands to oral octreotide capsules retain biochemical control of acromegaly. The medical evidence supports the requested medication in this clinical setting. Therefore, Mycapssa 20 mg capsule DR is medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 

A 30-year-old male enrollee has requested reimbursement for chemical dependency intensive outpatient treatment provided from 5/22/18 through 5/29/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. The patient did not demonstrate or complain of post-acute withdrawal symptoms.  He was not a danger to himself or others. There were no emotional, behavioral, cognitive, or impulsive symptoms which would have prevented step down to outpatient level of care. He was medically and psychiatrically stable, and his Wellbutrin could have been managed in an outpatient setting. There was no evidence of a high degree of impulsivity, agitation, depression, mania, hallucinations, or any other significant symptom that would interfere with his care. He was cooperative, motivated, and participating in his treatment plan. No new problems had arisen. The patient demonstrated good insight and motivation, and there was no evidence to suggest that he would not successfully continue his recovery in the outpatient setting, in conjunction with community support, such as 12-step program with counseling. All told, chemical dependency intensive outpatient treatment provided from 5/22/18 through 5/29/18 was not medically necessary for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2


A 43-year-old male enrollee has requested reimbursement for Anser IFX testing performed on 8/09/15.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found some evidence exists that low serum levels of infliximab and/or the presence of antibodies to infliximab may play a role in primary or secondary response failures.  Antidrug antibodies develop in a substantial number of patients and may be responsible for acute drug infusion reactions as well as delayed hypersensitivity reactions.  In a large percent of patients who develop antibodies, such antibodies may disappear after continued treatment.  The reasons for therapeutic failures remain unclear.  Some evidence exists that low serum levels of infliximab or the presence of infliximab antibodies have an adverse effect on the clinical outcome of a patients response to treatment.  However, there are few well-controlled clinical trials to confirm that use of the Anser IFX testing leads to improved patient outcomes or quality of life as opposed to the standard method of treatment.  The clinical utility of measuring drug antibody concentrations has not been established, and it has not been established how patient management would change based on test results. Limited retrospective evidence describes changes in management after measurement to anti-drug antibodies, but does not compare these management changes to those made in the absence of anti-drug antibody measurement.  In sum, the superior efficacy of Anser IFX testing performed on 8/09/15 has not been established.  Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 

A 44-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 8/26/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees medical condition. The physician reviewer found that Tomosynthesis provides advantages relate to the tomographic nature of tomosynthesis and the associated ability to separate dense glandular elements from underlying architectural distortion. However, the technique is new and there is a lack of long-term studies showing an increased survival rate when tomosynthesis has been used versus cases where two-dimensional (2D) imaging alone has been performed. According to Friedewald and colleagues Addition of tomosynthesis to digital mammography was associated with a decrease in recall rate and an increase in cancer detection rate. Further studies are needed to assess the relationship to clinical outcomes. In sum, the use of 2D imaging alone is supported by the peer-reviewed literature, however the addition of tomosynthesis was not medically necessary. Therefore, the services at issue were not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Overturned

Summary  
The patient is a 13-year-old male with a history of idiopathic isolated growth hormone (GH) 
deficiency. The provider has recommended continued treatment with GH therapy. The Health 
Insurer has denied the requested treatment as not medically necessary for the treatment of the 
patients medical condition. This denial is the subject of this appeal and determination. The 
physician reviewer found that Skytrofa is U.S. Food and Drug Administration (FDA) approved for 
the treatment of pediatric patients with GH deficiency. According to Maniatis and colleagues, 
pediatric patients treated with once-weekly Skytrofa showed continued improvement of height 
SDs through the second year of therapy without excess advancement of bone age. The failure of 
two standard GH provocative tests, combined with a small pituitary gland, is consistent with a 
diagnosis of pediatric GH deficiency (Ibba and Loche). In this case, the patient failed to respond 
to glucagon and clonidine stimulating testing. An MRI of the patients brain revealed a relatively 
small pituitary gland for the patients age. Furthermore, based on this patients standing height and 
contemporary bone age, the patients predicted adult height before initiating treatment with 
Skytrofa was 65.9 inches, which is more than two SDs below his estimated MPTH of 72 inches. 
Therefore, prior to initiating treatment with Skytrofa, this patient met generally accepted and FDA-
approved diagnostic criteria for pediatric GH deficiency. Moreover, the records provided for 
review indicate that the patient has been tolerating and responding well clinically to Skytrofa, as 
demonstrated by the increase in the patients growth velocity. For these reasons, the requested 
Skytrofa is medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 

A 58-year-old male enrollee has requested authorization and coverage for magnetic resonance imaging (MRI) of the pelvis. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that American Urologic Association guidelines note that the clinical indications for the use of MRI in the management of prostate cancer are rapidly evolving. Mowatt and colleagues noted owing to the relative paucity of reliable data, further studies are required. The authors noted that prospective studies are required in men with suspected prostate cancer and elevated PSA levels but previously negative biopsy comparing the utility of the MRI with both a magnetic resonance-guided/-directed biopsy session and an extended 14-core TRUS-guided biopsy scheme against a reference standard of histopathological assessment of biopsied tissue obtained via saturation biopsy, template biopsy or prostatectomy specimens. At this time, standard transrectal ultrasound and guided biopsy of prostate remains the initial diagnostic modality. Therefore, the requested MRI of the pelvis is not medically necessary for the evaluation of this patient.