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

Diagnosis: back pain
Treatment: Intracept Procedure
The insurer denied Intracept Procedure. 

The health plan's determination is upheld.

This is a  patient who is following up for cervical spondylosis. Physical exam (PE) revealed positive facet loading tests in the thoracolumbar region. She was recommended to have Intracept procedure. An magnetic resonance imaging (MRI) revealed loss of disc height and Modic endplate changes at L (lumbar)4-5 and L5-S (sacral)1 levels, right L4-5 foraminal stenosis and left L5-S1 foraminal stenosis.

The Intracept Procedure: Intraosseous Basivertebral Nerve Ablation is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
The Intracept system was designed to treat low back pain from vertebral body by ablating intraosseous nerves. The available medical records did not reveal adequate evidence that this patient's pain is from vertebral bodies. According to the records, this patient has severe pain secondary to trochanteric bursitis, and she has positive facet loading tests. None of these clinical facts are consistent with vertebrogenic pain. Current clinical studies supported the efficacy of Intracept procedure for vertebrogenic back pain. However, the patients with other chronic pain etiologies were excluded from these studies.
From reviewing the medical records and current clinical studies, this patient is not an appropriate candidate for Intracept procedure.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: back pain
Treatment: Intracept Procedure
The insurer denied Intracept Procedure. 

The health plan's determination is upheld.

The patient is a female with complaints of low back pain. An magnetic resonance imaging (MRI) lumbar spine reported degenerative changes as well as left L (left)5-S (sacral)1 foraminal stenosis. Prior treatments have included oral medications, including non-steroidal anti-inflammatory drugs (NSAIDs). She has undergone prior L4-L5 lumbar epidural injection.

The proposed Intracept procedure is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
The patient has complaints of low back pain. This procedure is not recommended Despite promising early reports, and further trials with longer-term outcomes and less risk of bias are required. An Food and Drug Administration (FDA) investigational device exemption trial examined 225 chronic low back pain patients with type I or II Modic changes who were randomized to the requested procedure or sham treatment, resulting in decreased Oswestry disability index (ODI) of 20.5 and 15.2 points, respectively. The authors noted that these marginally clinically meaningful improvements suggested some potential as a minimally invasive treatment, however, there is lack of data to recommend this procedure as treatment modality. In general, there is lack of substantial support for this procedure, and it is currently not considered standard of care.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Bilateral nephrolithiasis

Treatment: Inpatient admission

The insurer denied coverage for an inpatient admission

The denial is upheld. 

This is a female with no significant past medical history. She presented to the emergency department with complaints of abdominal and flank pain. She was admitted to the pediatric unit that day for bilateral nephrolithiasis. She improved with treatment and discharged the next day. The insurer has denied coverage for the inpatient admission as not medically necessary. They noted that she had kidney stones which she was able to pass, after she was admitted for abdominal/back pain. They felt that the patient's medical needs could have been treated in an observation setting for up to 48 hours. The appeal on behalf of the hospital is noted and was read in detail. The patient's imaging showed a 0.4 cm (centimeter) obstructing calculus in the left lower pole and a 0.3 cm calculus within the right ureterovesicular junction. The patient received intravenous fluids, Toradol 15 mg (milligrams) intravenous, and morphine 4 mg intravenous in the emergency department. She passed the (likely) right distal ureteral stone the following AM (morning). Per MCG (Milliman Care Guidelines) Health (25th) renal colic and kidney stones, the patient fails to meet clinical indications for an admission to inpatient care. These include hemodynamic instability, bilateral obstruction, acute renal failure, and obstruction in a patient who has only one (solitary) kidney. The patient had only her right kidney obstructed by a small distal stone which passed in < (less than) 24 hours with medical management. 

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

The insurer's denial of coverage for an inpatient admission is upheld. Medical Necessity is not substantiated.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Anal Cancer
Treatment: Proton Beam Therapy
The insurer denied the Proton Beam Therapy.
The determination is upheld.

The patient has a prior history of acute myelogenous leukemia (AML) status/post (s/p) chemotherapy and stem cell transplantation and now presents with clinical (c) tumor (T) 2 nodes (N) 1 metastasis (M) 0 invasive squamous cell carcinoma of her anal canal. She has been recommended to proceed with a course of definitive chemoradiotherapy with curative intent. At issue is whether the proton beam therapy is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

The requested proton beam radiotherapy. is not likely to be more beneficial than standard of care photon-based intensity modulated radiation therapy (IMRT) in the patient's setting. Proton radiation is not proven to yield superior clinical outcomes for management of invasive anal cancer per the current peer reviewed medical literature and expert consensus national guidelines. The treating provider did not supply a customized proton/photon plan comparison to justify necessity of proton radiation in the patient's situation (the provided comparison was a representative case example and not specific to the patient). The patient had not previously received pelvic radiotherapy in the past, and she does not have a comorbid/genetic condition that increases her risk for normal tissue toxicity. Proton radiation in the member's setting is not supported by the American Society for Radiation Oncology (ASTRO) Model Policy outside the context of a prospective clinical trial. Therefore, the requested proton beam radiotherapy is not likely to be more beneficial than standard of care photon-based IMRT in the member's setting.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Anal Cancer.
Treatment: Proton Beam Therapy.
The insurer denied the Proton Beam Therapy.
The determination is upheld.

The patient presented with rectal pain and diarrhea. A biopsy established a diagnosis of tumor (T) 2 node (N) 1 squamous cell carcinoma (SCC) anal canal. At issue is whether proton therapy treatment is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

The proposed treatment proton therapy treatment is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. The standard of care for anal cancer is intensity modulated radiation therapy (IMRT).
The attending provider (AP) has provided dose volume histogram (DVH) comparison of intensity modulated radiation therapy (IMRT) and proton beam. The dose to the bladder is 2874 centigray (cgy) and to bowel is 3623 cgy from IMRT. This is acceptable and within the acceptable constraints of these organs.
The National Comprehensive Cancer Network (NCCN) guidelines do not recommend proton beam therapy for anal canal cancer. There are no published data to support Proton beam.
Therefore, it is not likely to be more beneficial than standard treatment(s).
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Anal Cancer.
Treatment: Proton Beam Therapy.
The insurer denied the Proton Beam Therapy.
The determination is upheld.

This patient has a history of acute myelogenous leukemia (AML) treated with chemotherapy and stem cell transplant with no evidence of disease. She now has an anal squamous cell carcinoma, staged tumor (T) 2 nodes (N) 1 metastasis (M) 0. Radiation therapy is recommended as definitive treatment and the proton beam approach is requested. At issue is whether proton therapy treatment is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
The proposed treatment of proton radiotherapy is not likely to be more beneficial than any standard treatment for the insured's life threatening disease.
There are lack of any significant clinical trials completed and published in peer reviewed journals supporting the benefits and safety of proton beam radiation therapy as compared to conventional photon beam intensity modulated radiation therapy (IMRT). There are no comparison plans provided for this patient to show the potential benefits of proton beam radiation as compared to IMRT photons. Until the ongoing clinical trials are completed and evaluated after maturing as well as published in peer reviewed journals showing the benefits and safety of proton beam radiation therapy over conventional photon beam IMRT, the requested proton beam radiation therapy is not likely to be more beneficial than any standard treatment for the insured's life threatening disease.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Skin Disorders. 
Treatment: Inpatient Hospital. 
The insurer denied inpatient stay. 
The denial is overturn.  

The patient is a male with past medical history of diabetes mellitus type 2, hypertension, fatty liver, depression, alcoholic pancreatitis with pseudocyst, and tobacco abuse who presented to the emergency department on with complaints of an infection on his left hand. The patient started with symptoms 5 days before, had been out of the area and went to urgent care and was prescribed Keflex but without improvement in symptoms then went to an emergency room out of the area and was prescribed doxycycline and clindamycin. The patient did not have improvement. The subject under review is the medical necessity for the inpatient stay.

The health plan's determination is overturned.

The patient was admitted to the hospital with large ulcer and cellulitis of the left hand after failed outpatient treatment x2 with oral antibiotics and incision and drainage (I & D). The patient had greater than (>) 5 days of oral antibiotics with progression of infection. The patient was at high risk for complication due to his diabetes and lack of improvement with oral antibiotics. The patient was treated with IV antibiotics. The patient had a consultation with infectious disease and orthopedics. Orthopedics also documented the patient had I & D in the outpatient setting and had worsening symptoms. At the time of admission, the patient was at high risk for decompensation, required complex intravenous therapy, and required urgent consultation with infectious disease. Inpatient stay was medically necessary for this patient.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Skin Disorders. 
Treatment: Inpatient Hospital. 

The insurer denied inpatient stay. The denial is upheld.  

The patient is a male with past medical history of diabetes mellitus type 2, hypertension, fatty liver, depression, alcoholic pancreatitis with pseudocyst, and tobacco abuse who presented to the emergency department on with complaints of an infection on his left hand. The patient started with symptoms 5 days before, had been out of the area and went to urgent care and was prescribed Keflex but without improvement in symptoms then went to an emergency room out of the area and was prescribed doxycycline and clindamycin. The patient did not have improvement. The subject under review is the medical necessity for the inpatient stay.

The health plan's determination is overturned.

The patient was admitted to the hospital with large ulcer and cellulitis of the left hand after failed outpatient treatment x2 with oral antibiotics and incision and drainage (I & D). The patient had greater than (>) 5 days of oral antibiotics with progression of infection. The patient was at high risk for complication due to his diabetes and lack of improvement with oral antibiotics. The patient was treated with IV antibiotics. The patient had a consultation with infectious disease and orthopedics. Orthopedics also documented the patient had I & D in the outpatient setting and had worsening symptoms. At the time of admission, the patient was at high risk for decompensation, required complex intravenous therapy, and required urgent consultation with infectious disease. Inpatient stay was medically necessary for this patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Bleeding from uterus and anemia
Treatment: Inpatient hospital admission
The insurer denied the inpatient hospital admission.
The denial is upheld.

The patient is a female with developmental delay presenting with bleeding from the uterus and anemia. She was evaluated and was noted to be normotensive and slightly tachycardic. She was admitted for inpatient level of care and had a blood transfusion.

No, the proposed inpatient hospital admission was not medically necessary.

The patient was never hemodynamically unstable, she was always able to ambulate, void, and take oral medications and an oral diet.  The interventions she received, including the blood transfusion, could have been delivered safely and more medically appropriate at the observation level of care. Inpatient care as rendered in this case is not supported by peer reviewed data, it is not standard of care, and it is not supported by professional organizations.

Yes, the health plan acted reasonably.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Digestive System/Gastrointestinal/Gastroesophageal Reflux Disease/GERD
Treatment: Surgical Services (All)
The health plan denied the requested surgical procedure as experimental/investigational. 
The health plan's determination is upheld.

This patient is a male with a history of gastroesophageal reflux disease (GERD) and regurgitation. An esophagogastroduodenoscopy (EGD) reports a large hiatal hernia (HH) and esophagitis. Pathology did not reveal findings of intestinal metaplasia. Per medical records, the hiatal hernia is reported to be 6.8 cm (centimeters). Esophageal manometry was reported to be normal. A 24-hour potential hydrogen (pH) study revealed an elevated DeMeester score of 22.9, consistent with GERD.
At issue is whether the proposed health service or treatment of a LINX Reflux Management System is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

The health plan's determination regarding the proposed health service is upheld, in whole.

No. This patient has GERD and regurgitation. Surgical treatment options that are considered standard today include laparoscopic Nissen fundoplication and the LINX procedure. Both of these treatments have been shown in published studies to be more effective than medical management. LINX is comparable for mid-long-term studies to be as effective and durable as laparoscopic Nissen fundoplication with less risk of mortality and major morbidity. It has been recommended based on the available published literature to be a standard surgical treatment for GERD in nationally published guidelines from the Society for Gastrointestinal and Endoscopic Surgeons. Exclusions to LINX treatment include age < 18, pregnancy, metal allergy, body mass index (BMI)>35 kg/m2, HH > 3 cm, Barrett's esophagus with dysplasia and esophageal motility disorder. This patient has findings of a hiatal hernia that is reported to be very large on EGD and 6.8 cm in the medical records. A hiatal hernia of > 3cm is generally considered to be an exclusion to LINX treatment. LINX treatment has not been fully studied in situations of very large or gigantic hiatal hernias and this finding would be considered an exclusion to treatment.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Digestive System/Gastrointestinal/Gastroesophageal Reflux Disease/GERD
Treatment: Surgical Services (All)
The health plan denied the requested surgical procedure as experimental/investigational. 
The health plan's determination is upheld.

The patient is a male with gastroesophageal reflux and hernias including ventral, inguinal and hiatal. He is reported to have progressive reflux and regurgitation, but no dysphagia or chest pain. Endoscopy demonstrates what is described as a large hiatal hernia. Potential hydrogen (pH) measurement demonstrates elevated acid exposure with a DeMeester score of 22. Biopsies of the gastroesophageal (GE) junction showed nonspecific inflammation and no Barrett's esophagus. Antral gastritis was noted. High resolution manometry demonstrated normal peristalsis, and lower esophageal sphincter (LES) pressure is low. This review concerns the medical necessity of the LINX procedure.
At issue is whether the proposed health service or treatment of the LINX Reflux Management System is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

The health plan's determination regarding the proposed health service is upheld, in whole.

No, the LINX Reflux Management System is not likely to be more beneficial than standard treatments for this patient's condition.
LINX has not been demonstrated to be more beneficial than standard proton pump inhibitor (PPI) and surgical fundoplication. Studies of the LINX system have predominantly been shorter term, industry funded, or non-randomized to standard therapies. While shorter term data indicates LINX reduces acid reflux and may offer less bloating than surgical fundoplication, a number of questions and concerns remain. Chief among these is the longer-term risks of erosion of this encircling device at the anatomic, vulnerable location of the esophagus. Additional concerns include subgroups which may benefit to a lesser or greater degree, such as this patient with a larger hernia, but a fairly low DeMeester score, gastritis, and regurgitation as features. Inadequate subgroup analysis has been completed to offer meaningful guidance and has not demonstrated superiority over standard treatment.
In a comprehensive review, Guidozzi noted favorable results in reducing gastroesophageal reflux disease (GERD) in published studies, but noted, "There is an urgent need for randomized data directly comparing fundoplication with magnetic sphincter augmentation (MSA) for the treatment of GERD to truly evaluate the efficacy of this treatment approach."[3].
In a 2021 review, Schizas writes, "The findings of our review suggest that MSA has the potential to bridge the treatment gap between maxed-out medical treatment. However, further studies with longer follow-up are needed for a better elucidation of these results." [2]
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Atopic dermatitis
Treatment: Dupixent injection 200 milligrams (mg)
The insurer denied coverage for Dupixent injection 200 mg.
The denial is overturned.

The patient is a male with a diagnosis of atopic dermatitis. The patient has failed therapy with high potency topical steroids, calcipotriol, tacrolimus ointment, betamethasone, fluocinonide, mupirocin, and light therapy. The requested medication is Dupixent.  

The patient has a diagnosis of severe atopic dermatitis which would be amenable to systemic therapy. Due to the patient's age, and prior failure of numerous topical therapies as well as light therapy, the use of Dupixent is medically necessary. Oral systemic agents have a greater side effect profile and are not FDA (Food and Drug Administration) approved in children. Dupixent is FDA approved for children as young as 6 years of age. The decision is overturned. The use of Dupixent at the pediatric dosing indicated is approved.

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 Dupixent injection 200 milligrams (mg) is overturned. Medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Psoriasis
Treatment: Otezla 30 mg (milligrams), pre-service
The insurer denied the Otezla 30 mg, pre-service.
The denial is overturned.

The patient is a male with psoriasis, treated with topical steroids and phototherapy. His provider is requesting Otezla.

The health plan denied coverage of the request due to requirement for use of methotrexate or other systemic immunosuppressant.

Yes, the requested Otezla is medically necessary.

Otezla (apremilast) is a phosphodiesterase inhibitor, and therefore its mechanism of action is different from injectable biologics. Apremilast works intracellularly to modulate pro- and anti-inflammatory mediators.

The ESTEEM trial (randomized, double-blind) documented favorable response to apremilast over placebo at week 16. Side effects were generally mild and did not result in discontinuation. PASI75 (75% [percent] reduction in Psoriasis Area and Severity Index score) was seen in 33% of patients, and PASI50 (50% reduction in Psoriasis Area and Severity Index score) in 60%. Efficacy has been demonstrated in psoriatic arthritis as well, and it was first FDA (United States Food and Drug Administration)-approved for spondyloarthropathies.

However, there are no studies to date comparing the efficacy of Otezla to other systemic medications for psoriasis. It is an oral therapy and requires less medication monitoring (current data do not indicate a need for laboratory monitoring) and is not immunosuppressive. Otezla is now among the growing number of systemic therapies for psoriasis. Currently, there are no evidence-based medical guidelines indicating which therapy is best or delineating a step-wise approach to psoriasis. The guidelines of care for the management of psoriasis state that each patient requires individual tailoring, and a stepwise approach is not recommended. No evidence-based literature could be found to support the use of other therapies before Otezla.

Furthermore, 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 (janus kinase) inhibitors. Therefore, it would not be advisable to use a systemic therapy in this patient that can decrease vaccine efficacy and place this patient at higher risk of COVID-19 (Coronavirus 2019) complications when a safer alternative is available.

Therefore, given the above, the requested Otezla is medically necessary.

No, the health plan did not act reasonably, with sound medical judgment, or in the best interest of the patient.