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

Diagnosis: Orthopedic/Musculoskeletal. 
Treatment: Advanced Imaging Services. 
The insurer denied: MRI. 
The denial is overturned in whole.

The patient is a female who underwent lumbar fusion. The postoperative course was complicated by weakness, numbness, pain and falls while ambulating. Treatments tried include physical therapy and medications. A lumbar magnetic resonance imaging (MRI) report describes postoperative changes. A thoracic MRI is proposed to further investigate ongoing thoracic spine pain and the above symptoms. The subject under review is the medical necessity for the thoracic MRI.

The health plan's determination is overturned in whole.

A thoracic MRI is considered medically necessary to investigate ongoing pain and neurologic symptoms in this patient.

American College of Radiologist appropriateness criteria state (in part) "Those deemed to be interventional candidates, with LBP [low back pain] lasting for > 6 weeks having completed conservative management with persistent radiculopathic symptoms, may seek MRI" [1].

A review of spine MRI states "Degenerative disease of the spine is a leading cause of back pain and radiculopathy and is a frequent indication for spine MR imaging" [2].

In this case, the patient has thoracic spine pain and abnormal neurologic symptoms not explained on lumbar MRI. Conservative measures failed to provide improvements; therefore, MRI is considered medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Dental/Orthodontic Procedure
Diagnosis: Class I occlusion 
Treatment: Braces
The insurer denied braces. The health plan's determination is upheld. 

The patient in question is a male with a Class I occlusion with a slightly deep overbite and appropriate overjet. He has minor maxillary and mandibular crowding. He is in the mixed dentition with many permanent teeth yet to erupt. He is treatment planned for 24-30 months of orthodontics to correct his malocclusion.

The Comprehensive Orthodontic Treatment: Braces is not medically necessary for this patient.
There is no medical reason to correct his malocclusion with braces. While the patient has minor crowding, there is no anterior or posterior crossbite. There is no evidence of wear or periodontal recession. There are functional problems that may occur in the dentition that become more difficult, if not impossible, to correct if not addressed in adolescence. This patient presents with none of those conditions. Aligning his teeth will likely not increase chewing efficiency since masticatory efficiency is already highest in patients with a Class I occlusion. If his teeth were aligned it would provide a minor esthetic improvement but it would not create a medically significant improvement to the patient's health. For these reasons' treatment is not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Dental Disorder
Treatment: Braces and 12 monthly visits
The insurer denied the braces and 12 monthly visits.
The determination is upheld.

The patient has a skeletal class II malocclusion, mild maxillary crowding and mild mandibular crowding, severe overjet and severe overbite. At issue is the medical necessity for braces and 12 monthly visits.

Using the Handicapping Labio-Lingual Deviation (HLD) index, the malocclusion would score a 16 with no auto qualifiers. Auto qualifiers include cleft palate deformity or cranio-facial anomaly, impacted permanent anteriors where extraction is not indicated, anterior crossbite causing clinical attachment loss and recession of the gingival margin, severe traumatic deviations, overjet 9mm or greater and underbite 3.5 millimeters (mm) or greater. The case requires a score of 26 or more for treatment to be considered medically necessary. The malocclusion in question does not meet the criteria to be classified as handicapping and treatment would not be considered medically necessary. Thus, braces and 12 monthly visits are not medically necessary in this case.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Cardiac/Circulatory Problems. 
Treatment: Inpatient Hospital. 
The insurer denied: Inpatient stay. 
The denial is upheld in whole.

The patient is a male who presented to the emergency department (ED) via Emergency Medical Services (EMS) with a chief complaint of chest pain. His pain resolved with aspirin and nitroglycerin in the ambulance and he was pain-free upon arrival to the ED. His medical history was remarkable for hypertension, diabetes, hyperlipidemia and cigarette smoking. In the ED, his blood pressure was 130/100 millimeters of mercury (mmHg) with a heart rate of 74 beats/minute. His respiratory rate was 18/minute with a room air oxygen saturation of 97%. His physical exam was unremarkable. His electrocardiogram and serum troponin level were normal. His chest x-ray showed no acute pathology. He was admitted to the hospital to rule out acute coronary syndrome. He had no further chest pain. Serial troponin levels remained normal. His oral antihypertensive regimen was adjusted. An echocardiogram was performed and was normal and rest/stress myocardial perfusion imaging showed no evidence of ischemia. The patient was discharged.
Medical necessity for an inpatient stay is the subject under review.

The health plan's determination is upheld in whole.

An inpatient stay was not medically necessary. This patient, with multiple cardiac risk factors, presented with symptoms that were thought to be suspicious for acute coronary syndrome (ACS). Accordingly, monitoring until ACS could be ruled out was a reasonable approach. He was hemodynamically stable, with normal cardiac biomarkers, and no ischemic electrocardiographic changes. He did not require intensive monitoring or infusion of intravenous cardioactive medications. There is no indication in the records provided that other potentially life-threatening diagnoses were considered likely. The care this patient received did not require an inpatient admission and could have been provided under a lower level of care status. This approach has been shown to be both safe and is in accordance with the 2014 American Heart Association (AHA)/American College of Cardiology (ACC) Guideline for the Management of Patients with Non-ST-Elevation Acute Coronary Syndromes. Moreover, it should be noted that, based on the records provided, there was no medical reason for the delay in performing this patient's cardiac stress test given that he was pain-free with normal serial cardiac biomarkers and a normal electrocardiogram.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Cardiac/Circulatory problems
Treatment: Inpatient stay

Diagnosis: Cardiac/Circulatory Problems/Stroke/CVA
Treatment: Inpatient stay
The health plan denied the inpatient stay as not medically necessary. The reviewer has upheld the health plan's determination in whole.

The patient has a history of diabetes, bipolar disorder and schizophrenia and  presented to the hospital  with dizziness and visual changes. The patient reported painful vision loss bilaterally for the past five hours. The patient denied fevers, chills, headache, neck pain, nausea, and vomiting. Vital signs showed blood pressure 160/90 heart rate 106 temperature 98.4 Fahrenheit. On physical exam, heart was regular, breath sounds were normal, visual acuity was 20/25 bilaterally, there was no photophobia, cranial nerves appeared intact. Motor strength was decreased in the right upper and lower extremities. Initial head computed tomography (CT) scan was negative for acute stroke. The patient was admitted for suspected acute cerebrovascular accident (CVA) with right sided hemiplegia. The plan of care included an order to repeat brain CT without contrast, neuro checks, neurology consult, aspirin, statin, permissive hypertension, and continue other home medications. The patient also received counseling for cocaine cessation. Imaging was negative and the patient was thought to have a transient ischemic attack (TIA) versus migraine headache. Echocardiogram showed no intracardiac thrombus. CT angiogram of the head was also negative for acute abnormalities. The patient was discharged on July 14 with suspected TIA versus CVA versus migraine.

Inpatient hospital admission was not medically necessary.
The patient presented with weakness and visual changes, with concern for suspected CVA, but was hemodynamically stable with negative initial head CT imaging. The plan of care included an order to repeat the brain CT without contrast, perform neuro checks, neurology consult, aspirin, statin, permissive hypertension, and to continue other home medications. In addition, vitals were largely unremarkable after initial presentation with no evidence of hypertensive urgency or emergency, no evidence of sepsis, no evidence of seizures or acute withdrawal, and no evidence of other acute abnormalities. Overall the patient was stable and could have safely and effectively been managed at a lower level of care. There was no evidence of other hemodynamic abnormalities that could have justified a higher level of care.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Genitourinary/Kidney Disorder
Treatment: Infertility Treatment

Diagnosis: Genitourinary/Kidney Disorder/Female Infertility
Treatment: Infertility Treatment/IVF
The health plan denied the service as not medically necessary. The reviewer has upheld the denial in whole.

The patient has unexplained infertility and has previously gone through in vitro fertilization (IVF) and had a chromosomally normal embryo cryopreserved. The patient desires an additional IVF cycle.

The service of In Vitro Fertilization, additional cycle is not medically necessary at this time for the immediate treatment of infertility for this patient. Though the chances of implantation and pregnancy with a chromosomally normal embryo created from a woman 40 year old woman does not equal that of an embryo created from a woman less than 35, the chances of successful pregnancy may range at centers from 40-70%. This patient does have a reasonable chance of pregnancy using this embryo. The purpose of creating and cryopreserving additional embryos is useful for age-related fertility preservation. As the patient has an embryo available for embryo transfer, it is not medically necessary to perform an additional IVF cycle before embryo transfer for the opportunity to achieve pregnancy.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Rectal Cancer with Metastasis
Treatment: Radiation Therapy (Proton)
The health plan denied the requested service. 
The health plan's determination is upheld.

This is the case of male patient who presented with metastatic rectal cancer. The patient was treated with chemo followed by a hepatectomy. The patient then developed lung metastasis and was treated with chemo followed by Stereotactic Body Radiation Therapy (SBRT). The patient later had a repeat SBRT lung. The patient had brain metastasis and was treated with surgery followed by SBRT and then stereotactic radiosurgery (SRS) for dural based lesion. Recently, right upper lobe (RUL) and right lower lobe (RLL) lung lesions progressed, and the patient is being evaluated for Proton beam. This is the subject of review.

The health plan's determination of medical necessity is upheld.

No, the requested health service/treatment of Proton therapy is NOT medically necessary for this patient.
Proton beam is medically necessary and appropriate in pediatric cancers, uveal melanoma, chordoma and chondrosarcoma of base of skull etc. There is no medical literature to support Proton beam for this medical condition. National Comprehensive Cancer Network (NCCN) guidelines do not support Proton beam for this clinical scenario.
This patient has widespread metastatic cancer with multiple recurrence in lung. he can be treated with palliative radiation using other technique like intensity modulated radiation therapy (IMRT). The attending physician has not provided any DVH (dose volume histogram) comparison of Proton beam vs photon-based radiation therapy (RT) suggesting any superior clinical outcome or dosimetric advantage of Proton over photon-based treatment. There is no justification for Proton beam. The attending physician mentioned that this is a retreatment of the lung, which is not sufficient to justify use of Proton beam for palliative RT.
Using particle-beam therapy rather than photons offers the potential for further advantages because of the unique depth-dose characteristics of the particles, which can be exploited to allow still higher dose escalation to tumors with greater sparing of normal tissues, with the ultimate goal of improving local tumor control and survival while preserving quality of life by reducing treatment-related toxicity. However, the costs associated with particle therapy with protons are considerably higher than the current state of the art in photon technology, and evidence of clinical benefit from protons is increasingly being demanded to justify the higher financial burden on the healthcare
In this case, patient has widespread metastatic cancer and there is insufficient data for Proton beam for metastatic cancer to lung. Conventional 3D CRT (3-Dimensional Conformal Radiation Treatment)or IMRT is safe, effective and medically appropriate. Proton beam is more costly and not shown to be clinically superior compared to conventional palliative photon beam RT.
Appeal type: Medical necessity
Decision: Upheld

Skin Disorders
Oxygen/Oxygen Treatments

Diagnosis: Left leg wound
Treatment: Topical Hyperbaric Oxygen Wound Therapy 
The insurer denied the Topical Hyperbaric Oxygen Wound Therapy. The health plan's determination is upheld. 

This male has a left leg wound that has been treated with irrigation and debridement, negative pressure dressing and topical oxygen therapy. According to the office notes, the wound has healed considerably with topical oxygen therapy. The etiology of the wound is listed as "post-op." Under review is the use of topical hyperbaric oxygen wound therapy.

The Topical Hyperbaric Oxygen Wound Therapy is not medically necessary for this patient.

Topical oxygen therapy is not supported by the peer reviewed literature and is not medically necessary for this patient. To date, mechanisms of action whereby topical oxygen might be effective have not been defined or substantiated. Conversely, cellular toxicities due to extended courses of topical oxygen have been reported, although again these data are not conclusive, and no mechanism for toxicity has been examined scientifically. Generally, collagen production and fibroblast proliferation are considered evidence of improved healing, and these are both enhanced by hyperbaric oxygen therapy. Paradoxically, claims of decreased collagen production and fibroblast inhibition in wounds subjected to topical oxygen have been reported in studies of topical oxygen as a benefit of topical oxygen therapy. The literature on topical oxygen is mostly small case series or small controlled but not randomized trials. Moreover, the studies generally are not aimed at specific ulcer types, but rather at "chronic wounds."

This non-specific approach is recognized as a major design flaw in any study of therapies designed to improve impaired wound healing. I am unable to identify any literature which establishes, in a prospective, randomized trial, that topical HBO (hyperbaric oxygen) is an effective treatment for diabetic or postoperative foot ulcers. To the contrary, a randomized, controlled study by Leslie et al came to the following conclusion: "A trend toward slower healing was observed in the THO group. Healing of diabetic foot ulcers was not accelerated by THO (topical hyperbaric oxygen treatment) in this study."
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Skin Disorder. 
Treatment: Pharmacy/Prescription Drugs. 
The insurer denied: Dupixent. 
The denial is upheld in whole.

The patient is a female with atopic dermatitis (dyshidrosis) with symptoms persistent across her hands. According to the clinic notes, the patient consumes less than one alcoholic drink per day. According to the clinic notes, the patient has tried and failed topical clobetasol, halobetasol, and tacrolimus ointments. The patient's dermatologist has recommended treatment with Dupixent. The subject under review is the medical necessity of treatment with Dupixent.

The health plan's determination is upheld in whole.

Treatment with Dupixent is not medically necessary for this patient.
The patient has no documented treatment failure with, or true medical contraindication to, either of the standard, first-line oral medications such as methotrexate, azathioprine, or mycophenolate mofetil. The patient's significant topical treatment history requires systemic therapy at this time, but the aforementioned oral therapies have not been utilized. Dupixent is not proven to be superior to all other alternatives as per comparative, controlled studies. Therefore, consistent with current medical literature, [1-4] the requested Dupixent is not medically necessary.
The concerns of the dermatologist are duly noted, but methotrexate, azathioprine, and mycophenolate mofetil are all recommended for off-label use for long-term treatment of moderate to severe atopic dermatitis. Appropriate counseling and monitoring are indicated for all systemic therapies. Although cyclosporine is not indicated for long-term use, the medications methotrexate, azathioprine, and mycophenolate Mofetil are commonly used for off-label purposes such as atopic dermatitis, psoriasis, pemphigus, and other immunological diseases with dermatologic manifestations. Both the American Academy of Dermatology [1] and current medical literature [2-4] describe these oral medications as safe and appropriate for use in the hands of trained dermatologists and compliant patients when treating atopic dermatitis.
Accordingly, these oral medications are both safe and standard of care for first-line systemic therapy in the treatment of moderate to severe atopic dermatitis.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: CMV (cytomegalovirus) s/p Heart Transplant
Treatment: Formulary exception for Prevymis 
The insurer denied the Formulary exception for Prevymis. 
The denial is upheld. 

The patient is a male with OHT (orthotopic heart transplantation) whose formulary exception for Prevymis is under review. The donor was CMV (cytomegalovirus)-positive, and recipient CMV-negative. Per the healthcare provider's note, the initial plan was to use valganciclovir for prophylaxis. The reason for Prevymis then being prescribed in lieu of valganciclovir is not documented.

No, the health plan should not cover the Formulary exception for Prevymis.

There is no documented rationale given as to why Prevymis should be used over the health plan's preferred agent, valganciclovir. Valganciclovir would be reasonably expected to provide the CMV prophylaxis that is being sought in this patient's case. Although evidence suggests Prevymis' potential efficacy, it is not FDA-approved for this patient's condition (1).

Therefore, given the above, the request for the Formulary exception for Prevymis cannot be supported or validated.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Transgender hormone therapy
Treatment: Formulary exception for Delestrogen 40 mg/mL
The insurer denied the Formulary exception for Delestrogen 40 mg/mL.
The denial is upheld. 

The patient is requesting Delestrogen (estradiol valerate intramuscular injection), which is not on the health plan formulary, for a transgender woman.  The health plan contends that oral estradiol tablets or estradiol patches, which are on the health plan formulary, are acceptable alternatives.

No, the health plan should not cover the proposed treatment.  

There are no high-quality prospective studies of head-to-head comparisons of different estrogen formulations for this indication.  In general, synthetic estrogens such as ethinyl estradiol are not recommended due to increased propensity for venous thromboembolism.  However, there are no data establishing superiority in terms of efficacy or safety for other estrogen formulations such as estradiol or routes of administration.  

There is a preference for patches or parenteral administration of estradiol compared to oral administration due to less first pass effect that could increase cardiovascular risk.  The first pass effect is the increased risk for drug-induced blood clotting due to the effect of the oral medication on the liver, which can be bypassed by routes of administration that do not involve absorption of the medication through the gastrointestinal tract.  There are no head-to-head comparisons of patch versus parenteral administration (the proposed pharmacy exception) of estradiol and therefore no demonstration of superiority of one route of administration versus another in terms of efficacy or safety.  Taking these factors into consideration, estradiol patch as proposed by the health plan is an acceptable alternative.  No evidence was presented that there is no alternative on the formulary, that the listed formulary alternatives are not recommended based on published guidelines or clinical literature, that the formulary alternatives will likely be ineffective or less effective for the member, that the formulary alternatives will likely cause an adverse effect, or that the patient is unable to take the required number of formulary alternatives for the given diagnosis due to a trial and inadequate treatment response or an expected adverse reaction or contraindication, or the patient has tried and failed the required number of formulary alternatives.  

The acceptability of estradiol patches for this indication and the underlying rationale is addressed by the 2017 Clinical Practice Guideline of the Endocrine Society for Endocrine Treatment of Gender-Dysphoric/Gender-Incongruent Persons.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Acute Myeloid Leukemia 
Treatment: Formulary exception for Prevymis 480mg 
The insurer denied the Formulary exception for Prevymis 480mg.
The denial is upheld. 

The patient is a female. The patient has acute myeloid leukemia (AML). She had breast cancer three years prior, and her leukemia was a treatment-related secondary AML.  She was treated with Vyxeos and had partial response.  Bone marrow revealed persistent AML with 20% blasts.  She was recommended for treatment most likely with venetoclax and azacitidine with allogeneic transplantation planned. She underwent haploidentical allogeneic transplantation.  Prevymis was prescribed for CMV (cytomegalovirus) prophylaxis.

No, the health plan should not cover the Formulary exception for Prevymis.

This patient is to be treated with pre-emptive therapy to prevent CMV reactivation.  Standard agents for this indication include ganciclovir, valganciclovir, and foscarnet.  Letermovir (Prevymis) is a newer agent that has been studied in solid organ transplant recipients in a limited fashion, but it has not been studied in allogeneic transplant recipients.  It is not considered a standard treatment in this setting.  A recent study examining this type of treatment did not include any patients treated with this agent, highlighting that it is not a standard option in this treatment setting. 

Given the lack of sufficient supporting evidence for use of this medication in patients treated with allogeneic transplantation, given that the health plan's preferred formulary alternative (valganciclovir) is an available effective standard treatment, and given that no evidence is provided evidence showing why valganciclovir cannot be used, the proposed Formulary exception for Prevymis (letermovir) is not medically necessary and should not be covered.

While valganciclovir has potential side effects and while the appeal letter stating that it is felt this medication would not be well tolerated was noted, there is no medical record information provided to substantiate exactly why this patient is not a suitable candidate for treatment with valganciclovir.  This patient underwent allogeneic transplantation but provided medical records are only from the period of time before the transplant was carried out.