Persius/hicric huggingface dataset:
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Plaque Psoriasis
Treatment: Sotyktu 6 milligrams (mg) tablet
The insurer denied Sotyktu 6 mg tablet.
The determination is upheld.

This patient has moderate to severe plaque psoriasis affecting up to 40% (percent) body surface area at baseline who has failed therapy with topical corticosteroids, methotrexate, Humira, Cimzia, Taltz, Skyrizi, and Tremfya. At issue is the request for coverage of Sotyktu.

The formulary drug options of Stelara, Enbrel, and Cosentyx would be more effective than the non-formulary drug (Sotyktu). Moreover, adverse effects of the formulary drug options are not expected. The patient has not tried and failed other available preferred plan alternative formulary drugs such as Stelara, Enbrel, and Cosentyx. Also, the patient does not have any documented contraindications to these other preferred plan alternatives. The remaining preferred plan alternative drugs are Food and Drug Administration (FDA) approved for moderate-severe plaque psoriasis and have shown good efficacy with acceptable safety profiles when used to treat plaque psoriasis.

Review of phase III clinical trial data shows Sotyktu achieving a 58.4% on the Psoriasis Area and Severity Index (PASI75) in psoriasis patients after 16 weeks of therapy. This is inferior to the PASI75 rates seen in phase III clinical trials with Cosentyx, which shows rates of 90 at its primary endpoint. The patient does not have a clinical reason to not use Cosentyx. Therefore, Sotyktu has inferior efficacy compared to an alternative treatment that is available for the patient to use instead of the requested medication.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Myasthenia gravis (with acute exacerbation). 
Treatment: Soliris. 

The insurer denied: Soliris. 
The denial is overturned. 

The patient is an adult male with myasthenia gravis and was recently hospitalized for myasthenia gravis exacerbation with refractory myasthenia gravis. The patient was initially Class I and then Class V on the Myasthenia Gravis Foundation of America's 
classification scale. The request for Soliris was previously denied as it was not documented that patient has class II, III or IV on the Myasthenia Gravis Foundation of America's classification scale. 

Soliris should be covered. 

Soliris should be covered as the evidence is strong in the medical literature regarding its effectiveness in refractory myasthenia gravis, which this patient has. There are no formulary alternatives as the patient is medically refractory which means that he has tried and failed other medications. The rationale for the plan's denial is irrelevant as the patient has refractory myasthenia gravis and classes are irrelevant.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: gluteal abscess.
Treatment: inpatient stay.
The insurer denied the inpatient stay. 
The health plan's determination is overturned. 

The patient is a young girl who presented with an abscess in her right gluteal fold. She was well until 3 days prior to presentation when she developed a pustule on her buttock. It subsequently increased in size and became erythematous. The day prior to presentation, it began draining purulent fluid. She was described as being fussy at daycare and was being treated with acetaminophen and Neosporin. She was brought to the emergency department due to the increasing size of the lesion and because of pain.

Inpatient admission was medically necessary for this patient.
This is a very young girl who presented with an abscess that was rapidly expanding and was in an area near her anal opening. She was febrile and tachycardic at the time of presentation, was experiencing pain, and had an elevated white blood count. She therefore required prompt initiation of parenteral antibiotics along with close monitoring and specialist consultation. She also was given intravenous fluids and was not allowed to eat or drink in the morning in case surgical intervention was needed.
The decision making at the time of admission for this patient was consistent with her young age, the presence of an expanding area of cellulitis and abscess in an area at risk for systemic spread, and the presence of systemic symptoms including fever, tachycardia, and an elevated white blood count. She required parenteral antibiotics in a hospital setting along with close monitoring for potential deterioration of clinical status.
Hospitalization for parenteral antimicrobial therapy is indicated for children with skin and soft tissue infection when they have systemic signs, including fever and tachycardia. It is also indicated when there is rapid progression of erythema. This patient had a rapidly worsening lesion and presented with fever, tachycardia, and an elevated white blood count. She therefore required an inpatient hospital admission for appropriate treatment and monitoring.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Abdominal Pain.
Treatment: Inpatient Hospital Admission.
The insurer denied: Inpatient Hospital Admission.
The denial is upheld.

The patient is an adult female with acute cholecystitis that presented to the emergency room with one month of pain that had worsened each time she had eaten food. The patient's HR (heart rate) was 102, but she had no evidence of sepsis. She had an ultrasound, which demonstrated sonographic evidence of acute cholecystitis. The patient was admitted at inpatient level of care and given IV (intravenous) antibiotics. She was advanced to a clear liquid diet the next day and was discharged after feeling better. Denial for inpatient level of care is being appealed.

The Inpatient Hospital Admission was not medically necessary.

Inpatient level of care for this case is not medically necessary. The patient had resolution of her tachycardia upon hydration and resolution of her abdominal pain. She tolerated a clear liquid diet quite quickly and she declined surgical intervention. She did not have a leukocytosis and continued to improve significantly on HD (hospital day) #2. Given that this patient was discharged quickly, and her cholecystitis was managed medically, inpatient level of care was not medically necessary based on the provided documentation.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Tooth Fracture
Treatment: D2950, core buildup to tooth # (number) 5, including pins and D2740, porcelain crown to tooth #5,
The insurer denied coverage for D2950, core buildup to tooth # 5, including pins and D2740, porcelain crown to tooth #5.
The denial is overturned.

Based on the submitted documentation which includes copies of one periapical radiograph, three intraoral clinical images, narrative letter from the dentist and insurer correspondence and relevant indirect restoration dental policy (cracked tooth), it appears that this patient presented for dental care. Failing long-standing direct placement restoration was noted on tooth # (number) 5. The dentist is requesting placement of full coverage crown due to failure of the restoration and significant tooth fracture. 

Upon review of radiograph and intraoral clinical images, it supports the recommended treatment. Tooth #5 exhibits a failing direct placement restoration with coronal fracture. There would be ample coronal structure remaining after core buildup. This tooth will then have adequate coronal structure for support of full coverage crown and adequate residual periodontal alveolar bone height. The standard of care in general dental practice would be placement of crown which would have an excellent long-term prognosis with the recommended treatment. Further, the clinical situation meets the insurer criterion for indirect restoration placement due to cracked tooth. 

The health plan did not act reasonably, with sound medical judgment, or in the best interest of the patient.

The insurer's denial of coverage for the D2950, core buildup to tooth #5, including pins and D2740, porcelain crown to tooth #5 is overturned. Medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Abdominal pain
Treatment: Inpatient hospital stay
The insurer denied the inpatient hospital stay.
The health plan's determination is upheld. 

The patient is a female admitted to the hospital. The patient had a gastric sleeve 4 months prior to emergency room (ER) visit. The patient presented with right lower quadrant (RLQ) pain associated with nausea and vomiting. The patient underwent a computed tomography (CT) scan which demonstrated marked thickening of the base of the cecum. On exam, she was afebrile with stable vitals. She was tender in the RLQ without guarding or rebound.

The inpatient hospital stay was not medically necessary.

The patient appeared to have an infectious or inflammatory colitis on presentation, unrelated to her recent gastric surgery. She did not have a surgical abdomen and her vital signs and admission labs were basically normal. By the next morning after admission, the patient was feeling significantly better confirming there was not a life-threatening underlying process. It is unfortunate the main differential was typhlitis as nothing about this case suggested that diagnosis. Once she was improved and the stool came back showing norovirus, she could have been safely discharged with standard recommendations for management of an infectious diarrhea along with as needed (PRN) medications such as ondansetron.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Neuroblastoma
Treatment: Chemotherapy Treatment Regimen (cyclophosphamide, topotecan and naxitamab)
The insurer denied the Chemotherapy Treatment Regimen (cyclophosphamide, topotecan and naxitamab).
The denial is upheld.

The patient in this case is a female child with relapsed high risk neuroblastoma. She was diagnosed and treated at that time with induction chemotherapy. Following that, she had resection done and then was treated with tandem autologous stem cell transplant, adjuvant radiation and dinutuximab plus GM-CSF (granulocyte macrophage colony-stimulating factor) and Cis-RA (13-cis-retinoic acid), which she completed.

The patient's cancer relapsed last year and she was treated with irinotecan, temozolomide and dinutuximab. She had response in the humerus but persistent disease in the skull, which was treated with radiation. However, after eight cycles of that combination, her cancer worsened. Treatment with cyclophosphamide, topotecan and naxitamab has been recommended.

The health plan should not cover the requested Chemotherapy Treatment Regimen (cyclophosphamide, topotecan and naxitamab).

This patient has been treated with another anti-GD2 (disialoganglioside GD2) monoclonal antibody in combination with chemotherapy, and her cancer has worsened. Natixamab is a newer, humanized anti-GD2 monoclonal antibody that is FDA (United States Food and Drug Administration)-approved for treatment of relapsed neuroblastoma in combination with GM-CSF and in patients who have achieved partial response, minor response or stable disease to prior therapy. There is no evidence showing that this antibody, combined with the proposed chemotherapy regimen in this case, can improve outcomes when used for treatment of neuroblastoma which is progressing on prior treatment with dinutuximab. No published studies could be identified showing or suggesting that this regimen will be effective, and this is not a standard use of natixamab. For these reasons, the requested treatment should not be covered.

The requested Chemotherapy Treatment Regimen (cyclophosphamide, topotecan and naxitamab) is not likely to be more beneficial.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Neuroblastoma
Treatment: Chemotherapy Treatment Regimen (cyclophosphamide, topotecan and naxitamab)
The insurer denied the Chemotherapy Treatment Regimen (cyclophosphamide, topotecan and naxitamab).
The denial is overturned.

The patient is a female child. The patient is being treated for high risk neuroblastoma.  The issue under review is for chemotherapy treatment that includes cyclophosphamide, topotecan, and naxitamab. The treatment requested includes immunotherapy with stimulation of immune system.

Patients with chemo-resistant neuroblastoma treated with a combination of irinotecan temozolomide and immunotherapy with GM-CSF (granulocyte macrophage colony-stimulating factor). However, this patient has recently progressed on her taking temozolomide, therefore the combination of cyclophosphamide topotecan immunotherapy and GM-CSF has been requested.

The health plan should cover the requested Chemotherapy Treatment Regimen (cyclophosphamide, topotecan and naxitamab).

The requested Chemotherapy Treatment Regimen (cyclophosphamide, topotecan and naxitamab) is an appropriate treatment for the patient's condition.

The requested Chemotherapy Treatment Regimen (cyclophosphamide, topotecan and naxitamab) is likely to be more beneficial.

In the setting of chemo-resistant progressive or high risk neuroblastoma, the requested treatment is the most appropriate treatment for the patient. There is no standard-of-care for this particular disease, given its rarity. Therefore, the requested therapy is more likely to be beneficial given the available literature.

This child is a young girl with relapsed high risk neuroblastoma. The requested treatment with immunotherapy is well-supported by the evidence-based literature. Naxitamab DANYELZA is indicated, in combination with GM-CSF, for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy.

Immunotherapy is currently included for all high-risk patients as frontline standard therapy. Memorial Sloan-Kettering's chimeric antibody, which is under review, is now FDA (United States Food and Drug Administration)-approved for the treatment of neuroblastoma. The combination chemotherapy of cyclophosphamide and topotecan is a known combination that is active in neuroblastoma and is not incorporated into all frontline treatments. It is also utilized in the relapse setting. Therefore, based on the evidence-based literature, all of the requested treatment in this case would be considered medically appropriate and consistent with standard practice.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Multifocal Motor Neuropathy. 
Treatment: Octagam (Immune Globulin (IVIG)) (j1568- 50 grams daily times 3 days every 4 weeks). 

The insurer denied: Octagam (Immune Globulin (IVIG)) (j1568- 50 grams daily times 3 days every 4 weeks). 
The denial is overturned. 

The patient is an adult female with progressive weakness and numbness that has occurred for the last 15 years. She has been diagnosed with CIDP (Chronic Inflammatory Demyelinating Polyneuropathy). She has tried and failed Lyrica, gabapentin, amitriptyline and high dose steroids. Paraclinical workup showed elevated protein. Nerve conduction examination showed reduced conduction velocity, increased distal latency, conduction block, temporal dispersion in median and ulnar nerves, absent sensory responses and right sural nerve and absent left and right tibial reflexes. The Provider wishes to start IVIG (intravenous immunoglobulin). The request was previously denied as there was not clear evidence of CIDP (Chronic Inflammatory Demyelinating Polyneuropathy). 

The requested Octagam is medically necessary. 

IVIG (intravenous immunoglobulin) is medically necessary in this patient, as she has a confirmed diagnosis of CIDP (Chronic Inflammatory Demyelinating Polyneuropathy) as suggested by CSF (cerebrospinal fluid) testing as well as nerve conduction testing. IVIG (intravenous immunoglobulin) is first line treatment for CIDP (Chronic Inflammatory Demyelinating Polyneuropathy) treatment and has evidence throughout the medical literature supporting the safety and efficacy.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Plantar fasciitis
treatment: Foot inserts
The insurer denied foot inserts. 
The health plan's determination is upheld. 

The patient is a male who presented with a chief complaint of a painful flatfeet with pain on ambulation for the past 3-4 months. The patient has pain on the inside of his feet with ambulation. On exam, the patient has pain along his arches and inside of his ankles. He has a documented severe pes planus deformity with pronation and associated plantar fasciitis. The patient is noted to have an antalgic gait. He has a functional limb length discrepancy. Plantar fasciitis is noted. He is diagnosed with plantar fasciitis, posterior tibial tendonitis and flatfoot deformity bilaterally. 

After a review of the submitted documents, the requested Foot inserts are not medically necessary for this patient. The patient has had pain for the past 3-4 months. There is incomplete documentation of an adequate amount of a trial of conservative treatment before custom orthotics were requested. The notes document high voltage physical therapy has been tried but it is unclear of whether the patient has had formal physical therapy and what exact modalities have been tried. Thus, the requested foot inserts are not medically necessary for this patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Ovarian cancer

Treatment: Computed tomography (CT) scans of chest and abdomen/pelvis, codes 71250 CT thorax, diagnostic; without contrast material and 74176 CT, abdomen and pelvis; without contrast material.

The insurer denied coverage for CT scans of chest and abdomen/pelvis, codes 71250 CT,
thorax, diagnostic; without contrast material and 74176 CT, abdomen and pelvis; without contrast material.

The denial is upheld. 

The patient is an adult with ovarian cancer diagnosed and treated. No Evidence of Disease (NED) since that time. The treating provider has performed surveillance CT scans.

The surveillance CT scans are not considered medically necessary for this patient.

There is insufficient support for routine CT scans in ovarian cancer with absent signs or symptoms of recurrent disease, especially after years with stability. The National Comprehensive Cancer Network (NCCN) (2022) states that CT scans are only supported for investigation of signs or symptoms of recurrent disease. This patient has no signs or symptoms of disease recurrence and is beyond 5 years from last therapy. There is no role for routine surveillance scans in this setting. Therefore, the surveillance CT scans are not considered medically necessary for this patient.

Esselen, K. M., Cronin, A. M., Bixel, K., Bookman, M. A., Burger, R. A., Cohn, D. E., Cristea, M., Griggs, J. J., Levenback, C. F., Mantia-Smaldone, G., Meyer, L. A., Matulonis, U. A., Niland, J. C., Sun, C., O'Malley, D. M., & Wright, A. A. (2016), "Cancer antigen 125 (CA-125) tests and CT scans are routinely employed for surveillance testing in patients with ovarian cancer, although their benefit has not been proven and their use may have significant quality of life and cost implications."

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for surveillance CT scans of chest and abdomen/pelvis, codes 71250 CT, thorax, diagnostic; without contrast material and 74176 CT, abdomen and pelvis; without contrast material is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Left ventricular ejection fraction (LVEF).
Treatment:  Automatic external defibrillator.

The insurer denied coverage for automatic external defibrillator.  The denial is upheld.
 
The patient is an adult with a past medical history of ST elevation, myocardial infarction and percutaneous coronary intervention to the left main coronary artery last year. Subsequent work-up revealed left ventricular thrombus and ischemic heart failure with reduced ejection fraction of 20-25% (percent). Following treatment with guideline directed medical therapy including carvedilol and Entresto repeat echocardiogram demonstrated that left ventricular ejection fraction (LVEF) improved to 34%. The patient's physicians recommended an implantable cardiac defibrillator. The patient would not undergo an operative procedure, as he was the sole caregiver to his family member. An external LifeVest defibrillator for primary prevention of sudden cardiac death was prescribed. 

The patient presented with a depressed LVEF of 34% following six months of guideline directed anticongestive therapy. Past medical history was significant for ischemic cardiomyopathy. The Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) trial clearly demonstrated that such patients have a significant risk of sudden cardiac death and benefit from implantable cardiac defibrillator (ICD) therapy. (Reference 1) This patient's cardiologists appropriately attempted to treat reversible causes of cardiomyopathy prior to recommending an ICD. (Reference 2) Guideline statements from the Heart Rhythm Society/American Heart Association and the American College of Cardiology specify that wearable LifeVest defibrillator therapy should be utilized during periods when patients are at risk of sudden cardiac death and require further cardiac workup/treatment. (References 3-4) However, a wearable LifeVest defibrillator is not indicated when patients have a class I indication for ICD implant.  In conclusion, wearable defibrillator therapy is not medically necessary. In this case, an ICD should have been implanted.

The health plan acted reasonably, with sound medical judgment and in the best interest of the patient.

The insurer's denial of coverage for the automatic external defibrillator is upheld. Medical necessity is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Perforated otitis media
Treatment: Inpatient hospital admission
The insurer denied coverage for the inpatient hospital admission.
The denial is upheld.

This case involves an infant who presented to the emergency room with right ear discharge, temperature of 100.4 degrees Fahrenheit, and white blood cell count at 19,900. He was initially given Tylenol and intravenous ceftriaxone for a perforated otitis media. He was subsequently admitted for continued antibiotics with wound cultures positive for pan-sensitive Pseudomonas. The record stated that upon arrival, the patient looked well and was not in acute distress. He had purulent discharge coming out of the right ear, a similar area of dermatitis on his head, and eczema noted throughout the body. He was stable, afebrile, with ear swab sent for culture and sensitivity. 

According to the Milliman Care Guidelines, the patient did not meet criteria for admission to inpatient care. While it was noted that he was of a young age and had perforated otitis media, the patient responded favorably to initial treatment with intravenous ceftriaxone and Tylenol which reduced his temperature. The patient could have been observed for a short duration and then discharged with directions to continue oral medications and undergo follow-up with his primary care physician. After a review of the provided information, the denial of coverage was appropriate pertaining to the inpatient hospital admission as the patient did not display any significant abnormalities that would justify an acute level of care. 

The health plan acted reasonably, with sound medical judgment, and in the best interest of the patient.

The insurer's denial of coverage for the inpatient hospital admission is upheld. Medical necessity is not substantiated.