Persius/hicric huggingface dataset:
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Uterine Fibroids
Treatment: Ablation with Imaging Guidance

The insurer denied coverage for ablation with imaging guidance.
The denial is upheld.

This patient was seen for an annual evaluation.  She does have normal menstrual cycles; however, she does have heavy cycles.  She stated her fibroids are back.  She has undergone a prior myomectomy with dilatation and curettage (D&C).  The physical examination revealed no significant findings.  The documentation detailed she was recommended to undergo an endometrial biopsy due to heavy bleeding.  The physician indicated a magnetic resonance imaging (MRI) was needed to assess the number and location of fibroids.  An MRI reveals an enlarged leiomyomatous uterus measuring 17.6 centimeter.  The largest fibroid was in the midline posterior uterine body measuring up to 10 centimeters with heterogenous enhancement.  Malignant degeneration not excluded.
 
The scientific evidence in peer-reviewed literature does support a result of improvement in health outcome.

This patient is not a good candidate for ablation with imaging guidance for the treatment of uterine fibroids. Ablation with imaging guidance for the treatment of uterine fibroids is not the best available treatment for this patient at this time. The adverse risks are not increased over standard treatment/services.

According to the referenced literature radiofrequency ablation may be indicated when there is evidence of a leiomyoma documented by imaging, the patient desires uterine conservation, the patient is premenopausal, and there is documentation of testing that has ruled out other potential causes and greater than 3 months of persistent symptoms that include abnormal uterine bleeding that has been unresponsive to conservative management, bowel dysfunction, painful intercourse, infertility, iron deficiency anemia, pelvic pain or pressure, and/or urinary dysfunction.  The submitted documentation does not detail the above.  The documentation indicated per MRI malignant degeneration was not ruled out.  Additionally, the provided treatment detailed while there is a heavy bleeding complaint, it is noted that she is only bothered by the bleeding.  There are no additional symptoms.  Therefore, it does not appear she is appropriate per current literature to undergo the requested procedure.  

The requested treatment is not likely to be more beneficial than any other standard therapies.

The carrier's denial of ablation with imaging guidance for the treatment of uterine fibroids should be upheld.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Uterine Fibroids
Treatment: Ablation with Imaging Guidance

The insurer denied coverage for ablation with imaging guidance.
The denial is upheld.

The patient has a history of uterine fibroids, menorrhagia and pelvic pain. Transcervical fibroid ablation has been recommended and planned by her gynecologist.  

The medical records and medical literature were thoroughly reviewed. Options for minimally invasive uterus-sparing alternatives for the treatment of uterine fibroids, within the standard of care include myomectomy and uterine artery embolization. The novel use of radiofrequency ablation under laparoscopic and intra-abdominal ultrasound guidance to treat patients with symptomatic myomas was first introduced years ago. This has prompted the development of ultrasound-guided radiofrequency volumetric thermal ablation of uterine myomas in symptomatic women. The key feature of ultrasound lies in the inherent and immediate proximity of the transducer to the target (fibroid), allowing the use of higher frequencies with significantly increased resolution. Transcervical fibroid ablation (TFA) has certain advantages that might appeal to patients, including a noninvasive delivery method, uterine preservation, ability to treat a wide range of fibroid types, avoidance of general anesthesia, and rapid recovery and return to ADLs (Activities of daily living) following the procedure. The procedure is incisionless and preserves the uterus. Unlike operative hysteroscopy, TFA is designed for ablation of most nonpedunculated fibroid types.

The American College of Obstetrics and Gynecology, in its Practice Bulletin, considers TFA as not rigorously studied, does not support TFA as an effective treatment and not more beneficial compared to other standard medical and surgical options. There is no evidence in the medical literature to confirm that the proposed treatment, transcervical )TFA, is more beneficial than the standard treatment options including the surgical options of myomectomy and hysterectomy. The scientific evidence in the peer-reviewed literature does not support a result of greater improvement in health outcomes. Ablation with imaging guidance for the treatment of uterine fibroids has final approval from the appropriate regulatory bodies for this diagnosis. This patient is not a good candidate for ablation with imaging guidance for the treatment of uterine fibroids and is not the best available treatment for this patient at this time. The adverse risks are not increased over standard treatment/services.

The carrier's denial of ablation with imaging guidance for the treatment of uterine fibroids should be upheld.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Uterine Fibroids
Treatment: Ablation with Imaging Guidance

The insurer denied coverage for ablation with imaging guidance.
The denial is upheld.

The patient has a history of uterine fibroids, heavy menstrual cycles, and anemia. The physician recommended the Sonata procedure to treat fibroids. Radiological evaluation showed approximately 15 uterine fibroids.  The biggest fibroid was 10.8 x 7.7 centimeter.  The second biggest fibroid was 6 x 7.7 centimeter, and the third fibroid was 4.9 x 3.5 centimeter.

The Sonata System combines intrauterine ultrasound (IUUS) with radiofrequency (RF) ablation in a single handpiece. Sonata is suitable in an inpatient or outpatient setting and is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.

The Sonata system is Food and Drug Administration (FDA) approved for the management of fibroids. There are multiple studies documenting the safety and efficacy of this procedure in controlling symptoms due to fibroids.

Symptomatic improvement is observed within the first three months post-procedure, and this improvement has been maintained at least through 24 to 36 months of follow-up. 

Women treated with the Sonata pivotal trial experienced significant and durable reduction of fibroid-related symptoms, with low surgical reintervention rates over 3 years of follow-up. However, the use of the Sonata system in this patient's case is not the best available procedure as she has 2 fibroids greater in size than the 5 centimeter size that is reported in all the published studies about the efficacy and safety of Sonata. In other words, there is no data about the effectiveness of the sonata system in patients with large fibroids. As such the requested procedure is not the best available treatment.

Note that the patient with 15 fibroids as large as this patient's will benefit much more from a radical procedure like a hysterectomy rather than the Sonata system.
In summary, the requested procedure is not medically necessary.

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome.

Ablation with imaging guidance for the treatment of uterine fibroids have final approval from the appropriate regulatory bodies for this diagnosis.

This patient is not a good candidate for ablation with imaging guidance for the treatment of uterine fibroids.

Ablation with imaging guidance for the treatment of uterine fibroids is not the best available treatment for this patient at this time. Given this patient's presentation, number of fibroids and size of fibroids, a hysterectomy is the standard procedure.

The adverse risks are increased over standard treatment/services.

The requested service is unlikely to be more beneficial than any of the standard treatments/procedures for this patient.

The carrier's denial of ablation with imaging guidance for the treatment of uterine fibroids should be upheld.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Fracture of the left distal radius
Treatment: Inpatient hospital admission

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

This is the case of a female patient with a medical history of hypertension. The patient presented to the emergency department (ED) for evaluation of injury to the left wrist and shoulder following a mechanical fall. Radiographs of the left wrist were taken, and Orthopedic Surgery was consulted. The patient was admitted to Orthopedic Surgery for further surgical and postoperative management of a closed fracture of distal end of the left radius. She was discharged home 2 days later with follow up with the Orthopedic. 

Her clinical course was not complicated. She underwent surgery on a timely basis. There were no problems after her operation. She did not have temperature nor evidence of bleeding. There were no problems with the surgical site. She was able to tolerate oral pain medications. She did not require treatment for other underlying medical conditions. These facts do not substantiate the necessity for the inpatient admission and length of stay. The services could have been provided at a lower level of care. 

The medical record showed the patient sustained a grade 1 open fracture to her distal radius. The injury was of low energy. 

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 hospital admission is upheld. Medical Necessity is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Psoriasis

Treatment Otezla 30 mg (milligrams)

The insurer denied coverage for Otezla 30 mg

The denial is overturned

The patient is a female with a diagnosis of psoriasis and psoriatic arthritis. The patient is being treated with remicade for her psoriatic arthritis and requires therapy with otezla for control of her psoriasis.  The requested medication is Otezla (to be used in conjunction with Remicade for treatment of psoriatic arthritis).  

The use of Otezla is medically necessary in this clinical scenario based on the standard of care and the documentation provided.  The patient has a documented diagnosis of psoriasis that is moderate-severe in affected area.  The patient has failed therapy with numerous biologics, including Stelara, Siliq, Cimzia, Humira, Cosentyx, Taltz, and Tremfya.  The combination of Remicade and Otezla is needed to adequately control the patient's psoriasis and psoriatic arthritis.  As such, the use of Otezla in the setting of remicade is medically appropriate based on the standard of care and the provided documentation. The decision is reversed and the use of Otezla to threat the patient's Psoriasis is approved under the medical supervision of the treating physician.

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

The insurer's denial of coverage for Formulary Exception for Otezla 30 mg is overturned. Medical Necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Rheumatoid arthritis, coronary artery disease and macular degeneration

Treatment PCS (personal care services), 12 hours a day, 7 days a week, totaling 84 hours a week

The insurer denied coverage for PCS, 12 hours a day, 7 days a week, totaling 84 hours a week

The denial is overturned

The patient has multiple medical problems including rheumatoid arthritis, coronary artery disease and macular degeneration.  She lives alone in a private residence.  She currently receives Personal Care Services (PCS), 8 hours/day, 7 days/week and totaling 56 hours/ week. The request is for an increase of 12 hours a day, 7 days a week, totaling 84 hours a week.

According to the Uniform Assessment System (UAS) report, the patient requires maximal assistance to totally dependence for meal preparation, housework and shopping.  She requires extensive assistance for activities such as bathing, dressing and toilet use/transfers.  She is bladder incontinent and there are "mild" cognitive deficits with episodes of confusion.  Due to her macular degeneration she has vision deficits.  She is also hearing impaired; requiring hearing aids.  

As anticipated, her overall self-sufficiency has "deteriorated" over the past few days.  She uses a walker for ambulating short distances and requiring extensive assistance.  This aged female's functional, cognitive, and vision/hearing deficits will continue to decline, supporting an increase in personal care services (PCS), 12 hours a day, 7 days a week, totaling 84 hours a week to allow her to continue living safely at home.    

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

The requested coverage for personal care services (PCS), 12 hours a day, 7 days a week, totaling 84 hours a week is medically necessary.  Denial is overturned. Medical Necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Skin Disorders/Other/Atopic Dermatitis
Treatment: Pharmacy/Prescription Drugs
The health plan denied the requested medication, Dupixent as not medically necessary.
The health plan's determination is overturned.

The patient is a female with atopic dermatitis (AD) and asthma, treated with topical steroids, moisturizers, and systemic steroids. The atopic dermatitis is noted in the "flexural areas." The provider is requesting Dupixent.
At issue is the medical necessity of the requested medication, Dupixent.

The health plan's determination is overturned, in whole.

Yes. In May 2020, the Food and Drug Administration (FDA) also approved Dupilumab for the treatment of patients aged 6 years and older with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. This approval followed a phase 3, randomized, double blinded placebo-controlled trial that enrolled 367 patients to evaluate the safety and efficacy of Dupilumab in children (ages 6-11 years) for treatment of atopic dermatitis. Significantly and clinically meaningful improvements in patients' signs and symptoms of atopic dermatitis as well as quality of life were reported. As seen in adults, treatment in the pediatric population was reportedly well tolerated with the most commonly reported side effects including injection site reactions and conjunctivitis.
Given that this patient has asthma and atopic dermatitis, Dupixent is more appropriate. In the current COVID pandemic, this patient is at risk of more severe disease with baseline asthma. According to the multidisciplinary review (Gresham et al, 2021), vaccine efficacy may be reduced in patients receiving systemic immune-targeting therapies because of the impaired immune response in these patients. There is a trend toward a decreased immune response and vaccine immunogenicity in patients on systemic immunotherapies, particularly patients receiving Azathioprine, Cyclosporine, Methotrexate, Mycophenolate Mofetil, or JAK inhibitors. Therefore, it would not be advisable to use a systemic therapy in this patient that can decrease vaccine efficacy (should she become eligible for the vaccine) and place this patient at higher risk of COVID-19 complications when a safer alternative is available.
In addition, per the review by Ungar et al, patients on Dupilumab experienced less severe COVID-19 manifestations and lesser symptoms compared with patients on other systemics and on limited/no treatment. These results suggest that Th2 modulation with Dupilumab may have a protective effect on anti-viral immune response in patients with AD. Therefore, Dupixent is medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Cardiac/Circulatory Problems. 
Treatment: Surgical Services (All).
The insurer denied Transcatheter aortic valve replacement (TAVR). 
The denial is overturned. 

This case involves a female patient with a past medical history significant for hypertension, neuropathy diabetes mellitus, multiple myeloma status post chemotherapy, and severe symptomatic aortic stenosis. The patient has been referred for aortic valve replacement for treatment of severe symptomatic aortic stenosis and had been evaluated by a heart valve team including computed tomography (CT) surgery and Interventional Cardiology. Echocardiogram imaging demonstrated severe aortic stenosis, aortic valve area (AVA) 0.9 square centimeter (cm2) with borderline low gradient (mean AVA gradient 34 millimeters of mercury (mmHg) and peak 56 mmHg). Review of the patient's records indicated that according to her heart valve team evaluation, she had been recommended as an appropriate candidate for transcatheter aortic valve replacement (TAVR) and determined to be too high risk for surgical aortic valve replacement (SAVR) based on frailty and significant comorbid conditions. The patient's health plan has denied coverage for TAVR on the grounds that patient's records do not indicate criteria have been met for TAVR and is therefore not medically necessary. The patient's medical team is appealing this decision.
At issue is the medical necessity of Transcatheter aortic valve replacement (TAVR).

The health plan's determination of medical necessity is overturned in whole.

The requested health service/treatment of Transcatheter aortic valve replacement (TAVR) is medically necessary for this patient.
Based on the 2020 American College of Cardiology (ACC)/American Heart Association (AHA) guideline for the management of patients with valvular heart disease, the patient meets criteria for symptomatic severe aortic valve stenosis and would be an appropriate candidate for TAVR with expected improvement in symptoms and survival. Based on the patient's records, echocardiogram findings, and the heart valve team, this patient has symptomatic severe aortic stenosis and would benefit from a TAVR. The patient's calculated AVA is consistent with severe aortic stenosis, and she is evidencing New York Heart Association (NYHA) class 2-3 status. Her atrioventricular (AV) gradients are likely borderline due to her small left ventricular (LV) cavity size seen on cardiac imaging. Based on the 2020 ACC/AHA guideline for the management of patients with valvular heart disease, the patient meets criteria for symptomatic severe aortic valve stenosis and would be an appropriate candidate for TAVR. (1)
Therefore, the requested health service/treatment of Transcatheter aortic valve replacement (TAVR) is medically necessary
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Acute myelogenous leukemia
Treatment: Letermovir (Prevymis)
The insurer denied Letermovir (Prevymis).
The determination is overturned



The patient has a past medical history of acute myelogenous leukemia. The patient has undergone a haplo-identical stem cell transplant. The patient is cytomegalovirus (CMV) positive; the donor is CMV negative. Letermovir has been recommended as primary prophylaxis and is under review.
It is medically necessary.
Multiple trials have demonstrated the efficacy of letermovir with safety superior to alternatives in this patient populations. This agent is recommended by the National Comprehensive Cancer Network (NCCN) for use in high-risk patients, such as this one. The authors of UpToDate also consider this a reasonable option in this clinical scenario and state it "... is a potential alternative that has considerably less toxicity...". This agent is not currently the subject of ongoing investigation in this clinical scenario and numerous trials have supported its use and leading to similar outcomes to the formulary agents with less toxicity. The formulary alternatives include valacyclovir and ganciclovir, but the NCCN does not recommend those agents as a category 2A option for prophylaxis in this setting - only letermovir is. The NCCN does recommend these options for treatment of CMV.
For these reasons, the use of letermovir in this clinical scenario meets criteria for medical necessity.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Ear/Nose/Throat. 
Treatment: Pharmacy/Prescription Drugs/Dupixent. 
The insurer denied Pharmacy/Prescription Drugs/Dupixent. 
The denial is upheld.

The patient is a male with request for Dupixent for eosinophilic esophagitis (EOE). He has tried Protonix and budesonide. Esophagogastroduodenoscopy (EGD) shows eosinophilia. The subject under review is the medical necessity for Dupixent.

The health plan's determination is upheld.

The request for Dupixent is not medically necessary. EOE is not an approved condition for the use of Dupixent.
Benjamin L Spergel et al. conducted a retrospective chart review of all patients at Children's Hospital of Philadelphia and Rady Children Hospital who were prescribed dupilumab (Dupixent) for atopic dermatitis, asthma, or nasal polyps and had a concomitant clinical diagnosis of EOE. Demographic information along with histology, symptom scores, medications, and diet information were collected. Response to dupilumab was evaluated. A total of 45 patients were identified. Of which, 11 patients were prescribed dupilumab for asthma, 27 for atopic dermatitis, 3 for nasal polyps, and 4 for compassionate use for EOE. There was no follow-up data for 8 patients. Follow-up histology was available for 26 patients: 22 of 26 had less than 6 eosinophils per high power field after the initiation of dupilumab with significant improvement (pre: 52.9 + 35.1 to post: 4.5 + 10.9 eosinophils/high power field, probability [P] less than [<] .005). A total of 28 patients had improvement of symptoms, with 24 patients reporting complete resolution of symptoms after dupilumab initiation. Reductions in EOE treatment medications (swallowed steroids, proton pump inhibitors) or expansion of diet occurred in 29 patients treated with dupilumab. The authors concluded that dupilumab therapy initiated for atopic disease effectively induces symptomatic and histologic remission of esophageal disease and reduces the need for EOE-directed therapy in patients with concomitant EOE. However, this study is limited by the small number of patients and the retrospective nature.
The use of Dupixent for EOE is not supported by robust studies.  Studies are underway and this is not yet standard of care (SOC).