Persius/hicric huggingface dataset:
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohn's Disease.
Treatment: Stelara.
The insurer denied the Stelara.
The denial is overturned.

The patient is a male with moderate to severe Crohn's disease. He has failed Remicade and Humira, with ongoing active disease on most recent colonoscopy. His provider is requesting treatment with Stelara.

Yes, the requested Stelara is medically necessary.
The patient has luminal and perianal Crohn's that is refractory to treatment with two anti-TNFs (tumor necrosis factors). Stelara is safe and effective treatment for moderate to severe Crohn's. In fact, the most recent AGA (American Gastroenterological Association) Guidelines on Crohn's disease, referenced below, recommends, "In adult outpatients with moderate to severe CD [Crohn's disease] who never responded to anti-TNF [tumor necrosis factor] (primary nonresponse), the AGA [American Gastroenterological Association] recommends the use of Stelara (Strong recommendation, moderate certainty evidence) and suggests the use of Entyvio over no treatment for the induction of remission. (Conditional recommendation, low certainty evidence)." Therefore, as the literature and guideline support is stronger for Stelara in a patient such as this, the proposed Stelara is clinically appropriate, accepted standard of medical care and is medically necessary over the plan-preferred Entyvio.

No, as Stelara is more effective than Entyvio in the treatment of Crohn's when patients have failed anti-TNFs (tumor necrosis factors), the health plan did not act reasonably, with sound medical judgment and in the best interest of the patient by denying it.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Digestive System/Gastrointestinal.
Treatment: Pharmacy/Prescription Drugs/ Stelara 90 mg every 4 weeks.
The health plan denied the prescription drug  Stelara 90 mg every 4 weeks.
The reviewer has overturned in whole the health plan's determination.

The patient has Crohn's disease. She has failed Remicade, Cimzia, and Humira. She has been on Stelara. Colonoscopy with biopsies showed mildly active chronic ileitis. She now has breakthrough symptoms 5 weeks after Stelara injections. The coverage is requested for Stelara 90 milligrams (mg) every 4 weeks for the treatment of Crohn's disease.

Yes, the request for Stelara 90 mg every 4 weeks is supported in this case by current medical literature. Stelara is Food and Drug Administration (FDA) approved for the treatment of Crohn's disease, and a large randomized controlled trial demonstrated safety and efficacy of Stelara for induction and maintenance of remission in patients with moderate-severe Crohn's disease [1-3]. Guidelines for the treatment of Crohn's disease recommend the use of Stelara [4]. A study showed dosing intensification (90 mg every 4 weeks) was used frequently to address loss of response, and a large proportion of patients were able to maintain response [5-7]. One study showed that dose escalation was required and approximately half of patients, and successful in 61.1% of dose escalation attempts [5]. Another study showed efficacy of dose escalation to recover lost response in 73% of patients in whom it was attempted [7]. Additionally, American College of Gastroenterology guidelines for the treatment of Crohn's disease state that "Those with continued symptoms should be treated with an alternative therapy for mild to moderate disease, have their medication dose adjusted in order to attempt to optimize therapy" [4]. In this case, the patient has failed multiple other medications for the treatment of Crohn's disease, and failed Stelara every 8 weeks, with symptoms of active disease and evidence of active disease on colonoscopy. Continuation of dosing every 8 weeks, or discontinuation of Stelara (even if an alternative therapy is attempted immediately) may result in complications such as fistula, stricture, bowel obstruction, flare, hospitalization, need for surgery, or other complications of Crohn's disease. For all of these reasons, the request for Stelara 90 mg every 4 weeks is supported as medically necessary for the treatment of Crohn's disease in this case.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Multiple Sclerosis.
Treatment: Zeposia.
The insurer denied Zeposia.
The determination  is upheld.

The patient has relapsing-remitting multiple sclerosis. Treatment with Zeposia is requested. The member was started on samples. The plan denied the medication because the member had not used Gilenya, which has the same mechanism of action. The provider appealed the determination.
At issue is the medical necessity of Zeposia.

Zeposia is not medically necessary for this patient over the available formulary alternative of Gilenya. Both of these drugs are sphingosine-1-phosphate receptor 1 (S1P1) receptor modulators. Both drugs have similar side effects and risk profiles. Both drugs are Food and Drug Administration (FDA) approved for treatment of relapsing-remitting multiple sclerosis. There are no head-to-head clinical trials showing that Zeposia is  safer or effective than Gilenya. The patient does not have a clinical contraindication to the use of Gilenya.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Dental Problems-Teeth crowding.
Treatment: Orthodontic Treatment
The health plan denied the orthodontic treatment. 
The reviewer has overturned in whole the health plan's determination.

The patient in question has an anterior crossbite on teeth 9 and 10. She presents with a skeletal Class I malocclusion with moderate crowding in the maxilla and mandible. She is treatment planned for 24-30 months of orthodontics to address the crowding and crossbite, but the treatment was denied due to lack of medical necessity.

This patient presents with an anterior crossbite on teeth 9 and 10, as well as significant crowding. Side effects of an untreated anterior crossbite include abnormal wear to the affected teeth and labial displacement of the mandibular incisors that can lead to periodontal defects. Given the way that tooth 9 contacts tooth 24, it is a virtual certainty these teeth will develop abnormal wear if the crossbite is not corrected in a timely manner.
If left untreated the damage that will likely occur to the patient's teeth will be much more time consuming and costly to correct than the patient's existing orthodontic problem. For this reason, treatment is deemed medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Shortness of Breath
Treatment: Inpatient admission

The insurer denied coverage for inpatient admission.
The denial is upheld.

This is the case of a male who presented to the emergency room (ER) with complaints of a one-day history of a subjective fever, a cough, and wheezing. He was hemodynamically stable. Temperature was 102.4 Fahrenheit. He was given duo-nebulizers, Decadron, and Tylenol. A chest x-ray revealed findings that were consistent with bronchiolitis or atypical pneumonia. The patient was admitted to the Pediatric unit for care. He was placed on continuous pulse oximetry monitoring. He was given Albuterol, intravenous (IV) fluids, IV Ceftriaxone, and prednisolone. His condition improved and he was discharged.

If one were to assess the asthma severity such as Pediatric Asthma Severity Score (PASS) or Pediatric Respiratory Assessment Measure (PRAM), the score would indicate the patient needed only a lower level of care such as observational status or outpatient. Furthermore, the chest x-ray was within normal limits which is expected. Also, there was no underlying medical conditions such as chronic lung disease or congenital heart disease. There was also no need for high flow nasal cannula oxygen or bilevel positive airway pressure (BiPAP). The hospital course was suggestive of rapidly improving clinical picture. 

The patient could have been managed at a lower level. There was no need for repeated Magsulfate, no need for continuous nebs for prolonged time, no need for terbutaline drip or continuous steroids. The patient's saturation lowest was 93 to 95 percent.

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

The insurer's denial of coverage for the inpatient admission is upheld. Medical Necessity is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Chronic Venous Insufficiency of the Lower Extremities
Treatment: Code(s) 36465-RT, endovenous chemical ablation (Varithena)

The insurer denied coverage for code(s) 36465-RT, endovenous chemical ablation (Varithena).
The denial is overturned.

This case involves an adult female diagnosed with chronic venous insufficiency of the lower extremities. A lower extremity venous insufficiency duplex revealed right insufficiency of the small saphenous vein and anterior accessory great saphenous vein (GSV).  There was left insufficiency of the small saphenous vein with anterior accessory GSV.  Radiofrequency ablation was recommended.

Months after testing, the patient complained of bilateral leg pain.  There were varicose veins that were getting worse.  The patient tried compressive stockings and utilized medications without relief.  There was itchy skin, leg cramps, and leg swelling at the end of the day.  The previous duplex ultrasound showed several veins with venous reflux and a diameter of over 5.5 millimeters.  On examination, there were varicose veins bilaterally with spider veins.  There were hemosiderin deposits in the lower ankles.  Eczematous changes were present.  Edema was plus 3 and the Clinical Etiological Anatomical and Pathophysiological (CEAP) category was class IV (4).  Varithena administration was recommended.  The patient underwent the procedure and was observed for anaphylactic reaction without apparent incident or concern.  The patient was to follow-up in 1 to 2 weeks.

The bilateral SSV (small saphenous vein) and anterior accessory saphenous vein (AASV) ablations with Varithena are medically indicated and necessary for bilateral lower extremity chronic venous insufficiency.  The Varithena procedures are not investigational procedures but have been studied with literature in peer reviewed journals and are safe and effective treatments for venous insufficiency in the broad family of non-thermal venous ablations. This is an adult female with long-standing chronic venous insufficiency bilaterally.  She had symptoms of edema, pain, itching, eczema, lipodermatosclerosis and were clinical stage 4 of the Clinical-Etiological-Anatomical-Pathophysiological (CEAP) classification.  She had tried conservative management with elevation, avoiding prolonged standing and compression stockings, without benefit.  She was thus sent for venous reflux studies which revealed previous bilateral GSV ablations, and currently had bilateral AASV and SSV reflux.  

Thus, given that her reflux symptoms were refractory to conservative management, vein ablation was indicated.  Varithena was chosen as the treatment, which is a non-thermal ablative technique approved for use.  She has had left SSV and right AASV so far in their clinics and had tolerated well.  Therefore, the request is medically necessary. 

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 code(s) 36465-RT, endovenous chemical ablation, is overturned. Medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Bilateral leg pain, cramping, and edema
Treatment: Liquid or Foam Sclerotherapy

The insurer denied the Liquid or Foam Sclerotherapy.
The denial is overturned.

The patient is a female. The patient presented with bilateral leg pain, cramping, and edema. She had undergone bilateral GSV (great saphenous vein) ablation. She had failed a trial of compression stockings and Ibuprofen. Duplex showed bilateral small saphenous vein (SSV) enlargement (right 6.7 millimeter; left 5.8 millimeter) and severe reflux (right 1284 msec [milliseconds]; left 1266 msec [milliseconds]). Staged bilateral SSV (small saphenous vein) Varithena sclerotherapy ablation was done. Coverage was denied by the health plan on the basis that the treatment was not medically necessary.

Yes, the Liquid or Foam Sclerotherapy was medically necessary.

To evaluate the medical necessity of Varithena closure, the available published clinical data [1-5] regarding endovenous ablation of the axial and accessory saphenous veins has been evaluated. The procedure is medically necessary when: 1) The patient has venous insufficiency symptoms severe enough to affect normal function, 2) The patient has failed a trial of prescription compression stockings, 3) The patient has duplex-proven reflux affecting the vein in question, 4)	The modality of ablation is suitable for the vein in question.

Requirement 1 has been met. The records show that the patient presented with bilateral leg pain, cramping, and edema. The symptoms are described as being severe enough to interfere with normal activities.

Requirement 2 has been met. The office note states that the patient wore prescription stockings regularly and took Ibuprofen with only minimal benefit.

Requirement 3 has been met. The patient had a duplex showing bilateral small saphenous vein (SSV) enlargement (right 6.7 millimeter; left 5.8 millimeter) and severe reflux (right 1284 msec [millisecond]; left 1266 msec [millisecond]).

Requirement 4 has been met. Varithena closure of axial saphenous veins is supported by multiple studies [1,4]. Two recent large retrospective, comparative studies [4,5] showed that results of thermal ablation (e.g. laser, radiofrequency) and Varithena were equivalent across all CEAP (clinical condition, etiology, anatomic location, pathophysiology) classes.

Therefore, given the above, the patient meets published, well-accepted criteria for bilateral SSV (small saphenous vein) Varithena closure.

No, the health plan did not act reasonably, with sound medical judgment, and in the best interest of the patient.
The denial was based on the outdated notion that Varithena closure is not effective for patients with reflux at the saphenofemoral or saphenopopliteal junction. However, recent data [4,5] demonstrate equivalent results with Varithena and traditional thermal ablation techniques.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Atopic Dermatitis (AD). 
Treatment: Adbry. 

The insurer denied Adbry. The health plan's determination is upheld. 

The patient is a female with atopic dermatitis (AD). Body surface area affected is greater than 30%. She has failed tacrolimus ointment, prednisone, and mometasone ointment. She has also failed triamcinolone ointment. The medication under review is Adbry (Tralokinumab). 

Adbry (Tralokinumab) is not medically necessary for this patient. 
According to the American Academy of Dermatology Atopic Dermatitis Clinical Guidelines and dermatology literature, the generic medicines such as methotrexate are effective treatments for the management of atopic dermatitis. 
Within the peer-reviewed literature, in 2018, Gerbens et al writes "methotrexate (MTX) and AZA (azathioprine) seem to be effective and safe as maintenance treatments in moderate to severe AD up to 5 years" Shah et al 2018 writes "Methotrexate is an effective treatment for moderate to severe atopic dermatitis with an acceptable safety profile. A low dose can be used to control the disease for prolonged periods without significant risk". There are several published studies that show that methotrexate is effective and safe for moderate-severe atopic dermatitis. The evidence-based literature is consistent. There are no unique clinical circumstances to this particular individual that would make Adbry medically necessary. The patient has no true contraindications to the use of the preferred generic medications. The preferred agents, such as methotrexate, are appropriate agents for the treatment of the patient's atopic dermatitis. The formulary medications should be tried and failed prior to initiating Adbry. Therefore, Adbry is not medically necessary for this patient.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: breast cancer.
Treatment: Pharmacy/Prescription Drugs-Zarxio.
The health plan denied the formulary exception as the patient did not fail the formulary alternatives. 
The reviewer has Upheld in whole the health plan's determination.


The patient is a female with a diagnosis of right sided breast cancer, with axillary lymph-node involvement, stage T3N1 IIIA, Estrogen receptor positive, Progesterone receptor positive and Her2/neu negative disease currently undergoing neoadjuvant chemotherapy regimen of dose dense cyclophosphamide and doxorubicin followed by paclitaxel (dose dense AC-T). The treating physician prescribed Zarxio for treatment and prevention of neutropenia associated with myelosuppressive chemotherapy. Preferred product of the health plan is Nivestym.
At issue is whether the formulary drug, Nivestym, will be or has been ineffective, or would not be as effective as the non-formulary drug, Zarxio.

The health plan's determination is upheld in whole.

The formulary drug, Nivestym, would not be ineffective, and would be as effective as the non-formulary drug, Zarxio and would not have adverse effects.
Filgrastrim-sndz (Zarxio) and  filgrastim-aafi Nivestym are both biosimilar and have similar clinical efficacy and adverse effects. These two medicines are approved by United States Food and Drug Administration (FDA) for patients receiving myelosuppressive chemotherapy for prevention of neutropenic fever and therefore are interchangeable.
Therefore, the formulary drug, Nivestym would be as effective as Zarxio.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Breast Cancer
Treatment: Durable Medical Equipment (DME): Hospital Bed - a total of 1 unit
The insurer denied the Durable Medical Equipment (DME): Hospital Bed - a total of 1 unit
The denial is upheld

The patient has metastatic breast cancer. An appeal letter states that she has multifocal metastatic disease and that she has had a very complicated treatment course. This includes brain metastases and leptomeningeal disease. The letter states that her mobility is severely restricted and her strength is very limited, and for this purpose she requires a hospital bed.

No, the Durable Medical Equipment (DME): Hospital Bed - a total of 1 unit is not medically necessary.
The provided records do not clearly document the need for a hospital bed. Specifically, there is no documentation indicating why this patient would need a hospital bed that can raise and lower her head. There is no documentation indicating she has shortness of breath when laying flat, or that she needs the head of the bed raised due to aspiration risk or for any other reason. Also, no records are provided showing that she is home bound or that she has sufficiently limited mobility to make a hospital bed medically necessary.

Yes, the health plan did act reasonably, with sounds medical judgment, and in the best interest of the patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: thymic cancer
Treatment: Proton beam therapy
The insurer denied proton beam therapy. The health plan's determination is upheld. 

This is the case of a female patient who presented with locally advanced thymic cancer. The patient was treated with chemotherapy followed by surgery. Surgical margin was negative. She was recommended adjuvant radiation using Proton beam therapy. 

The requested Proton Beam Radiation Therapy (PBRT) is not medically necessary for this patient. Medically necessary treatment is defined as those treatment which are in accordance with generally accepted standard of care in US (United States).
Intensity modulated radiation therapy (IMRT) is the treatment which is in accordance with generally accepted standard of care in US. for thymic cancer.

There is no theoretical advantage with Proton for this rare clinical scenario. There is no proof that Proton beam therapy would improve net health outcomes compared IMRT. This is rare disease and there are not enough publications to support Proton beam in this case. The National Comprehensive Cancer Network (NCCN) guidelines do support Proton beam therapy in this case.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Quadriplegia, Bowel obstruction
Treatment: Inpatient Rehabilitation Center
The insurer denied Inpatient Rehabilitation Center.
The determination is upheld.

The patient has a diagnosis of quadriplegia as a result of a cervical (C) 4 American Spinal Cord Injury (AIS) A spinal cord injury. Her injury is described as C6 motor tetraplegia. She was admitted to the hospital for a bowel obstruction which required a left hemicolectomy, end colostomy. She had an increase in spasticity during her hospitalization and treatment included botulinum toxin injection to the bilateral elbow flexors and titration of oral medications.
The patient's baseline function is Hoyer dependent for transfers and she uses a power wheelchair. Her doctor describes her function prior to the hospitalization as modified independence for personal hygiene, grooming, and feeding. She was dependent on a Hoyer lift for transfer and was dependent for lower body dressing. She was in a nursing home prior to this hospital admission. Her provider's source of function information was from the patient and from the nursing home where she resides. He also documents that the patient's spasticity has worsened during her current hospitalization.
At issue is the medical necessity of inpatient rehabilitation.

The requested health service/treatment of Inpatient Rehabilitation is not medically necessary for this patient.
The patient's medical condition at this time does not require intensive rehabilitation. Her spinal cord injury and her current medical condition do not have a medical necessity for daily physician visits or rehabilitation inpatient nursing services. The patient does not have medical necessity for 3 hours of therapy per day. She is dependent in many activities of daily living, transfers, and is non-ambulatory. These are not new deficits for her as they date back several years to the spinal cord injury. Her physician documents that she has become less able to assist with dressing, grooming, transfers currently than prior to her hospitalization for bowel obstruction with resection and ostomy. She came from a nursing home setting prior to being in the hospital and will be discharged to the nursing home setting where she will continue to receive 24 hour care. The increase in spasticity and the care plan for spasticity described  can be treated by physician office visits. Spasticity management does not require the patient being in an acute inpatient rehabilitation center to treat the spasticity. Intensive acute inpatient rehabilitation is not medically necessary to meet her needs.