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

Diagnosis: Multiple sclerosis

Treatment: Vumerity (diroximel fumarate)

The insurer denied coverage for Vumerity (diroximel fumarate).

The denial is upheld.

This is a female patient with relapsing remitting multiple sclerosis (MS). The only drug she has tried was Plegridy. The patient had stopped taking it because of a likely unrelated viral infection. Imaging revealed at least 2 sizable lesions on the patient's magnetic resonance imaging (MRI) of the brain. The patient's provider stated that given the coronavirus disease 2019 (COVID-19) pandemic, it would be reasonable to try Vumerity (diroximel fumarate) (since the patient does not eat breakfast) and switch to infusion treatment with Ocrevus if ongoing clinical/ radiographic disease progression was present. 

The New Release related to Vumerity (diroximel fumarate) states that, "The FDA [Food and Drug Administration] approval of VUMERITY was based on a New Drug Application (NDA) submitted under the 505(b)(2) filing pathway. It included data from pharmacokinetic bridging studies comparing VUMERITY and TECFIDERA to establish bioequivalence, and relied, in part, on the FDA's findings of safety and efficacy for TECFIDERA".  The Drug Inserts for both Vumerity (diroximel fumarate) and Tecfidera (dimethyl fumarate) note that the medications are recommended for MS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults and they can be taken with or without food.  

According to Naismith, et al (2020), "diroximel fumarate (DRF) demonstrated an improved gastrointestinal tolerability profile compared with dimethyl fumarate (DMF), with less severe gastrointestinal events and fewer days of self-assessed gastrointestinal symptoms, fewer gastrointestinal adverse events, and lower discontinuation rates because of gastrointestinal adverse events".  However, without the patient having to first try the formulary drug, Tecfidera (dimethyl fumarate), it cannot be assumed that this patient would experience adverse gastrointestinal events that would make the medication intolerable to take. As per medical record, there is no indication that this patient has tried this medication in the past. As per literature review, the requested medication, Vumerity (diroximel fumarate) is a bioidentical drug of the formulary drug, Tecfidera (dimethyl fumarate). Therefore, the requested drug would not be more effective than the formulary drug. 

The insurer's denial of Formulary Exception for Vumerity (diroximel fumarate) should be upheld.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chest Pain
Treatment: Inpatient Hospital Stay
The insurer denied the Inpatient Hospital Stay
The determination is upheld.

The patient is a female with a past medical history of bipolar disorder, obesity, and thyroid disease. She presented to the emergency department after being referred there by her cardiologist for chest and back pain that had started a day and a half prior and was associated with radiation to her arms, dizziness, and blurry vision.

On presentation, she was afebrile with a blood pressure of 132/81, heart rate 83, respiratory rate 18, and and oxygen saturation of 98% on room air (RA). The exam otherwise noted the patient to be in no acute distress without any exam abnormalities. Labs resulted with a white blood cell count (WBC)of 6.6, hemoglobin (HGB) 15.8, platelets 171, basic metabolic panel within normal limits and troponin normal. An electrocardiogram (EKG) showed no clear acute ischemia or arrhythmia and a computed tomography (CT) angiogram of the chest, abdomen, and pelvis was unremarkable for dissection or aneurysm. The patient continued to have pain after emergency room interventions and given her HEART [History, ECG, Age, Risk factors and Troponin] score of 4, the patient was subsequently brought into the hospital to further evaluate for acute coronary syndrome. Overnight and the next day, she remained hemodynamically stable with troponins unremarkable and no evidence of acute ischemia on telemetry or arrhythmias. She underwent a Lexiscan which did not show evidence of clear reversible ischemia. She was given Toradol for pain, deemed stable for outpatient follow up, and subsequently discharged.

At issue is whether an inpatient stay was medically necessary.

An inpatient stay was not medically necessary. This is a patient who presented with chest pain without known history of coronary artery disease. She had a HEART score of 4. She was hemodynamically stable on presentation and throughout her hospital stay and had no evidence of cardiac ischemia on electrocardiogram with troponins also notably unremarkable. She furthermore was immediately ruled out for dissection or aneurysm as a cause of her symptoms. In the absence of hemodynamic instability, troponins or an electrocardiogram (EKG) suggestive of acute coronary syndrome, cardiac arrhythmia, or other acute cardiopulmonary process clearly identified causing symptoms with plans for serial troponins, telemetry, and stress testing, inpatient level of care was not medically necessary. Care could have been provided at a lower level.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Central Nervous System/Neuromuscular Disorder. 
Treatment:  Speech Therapy. 

The insurer denied the speech therapy.  The denial is upheld in whole.

The patient is a female who was referred to a speech-language pathologist (by family) for a language assessment, including writing.  At the assessment, the patient was administered the Clinical Evaluation of Language Fundamentals-5th edition (CELF-5) to assess receptive and expressive language abilities, as well as oral narratives where she had to retell the story using her own words.  The results of the CELF-5 (from two subtests) yielded results that were within normal range.  For the oral narratives, the patient struggled with questions related to detail.  Information from the report indicated that the school district believes the patient is functioning adequately.  Overall, the assessment revealed difficulties with language at the discourse level.  It was recommended that the patient receive language therapy focusing on narrative skills.  Additional case history also reveals that the patient received occupational therapy as a young child and has a history of enuresis.

According to documentation, there are progress notes for several therapy sessions.  Her clinician has noted progress with her narrative skills within these therapy sessions.  The subject under review is the medical necessity for the requested therapy services.

The requested treatment of speech therapy services are not medically necessary for this patient.

Clinical evidence has shown that children, who are diagnosed with language disorders, benefit from treatment.  More than 200 studies report the effectiveness of language intervention for an overwhelming majority of participants (1,2).  Language treatment has been shown to improve functional communication skills, thereby enhancing the quality of life, social, academic, and vocational opportunities of the child.

The patient does present with some deficits based upon the provided documentation.  However, for a need of medical necessity stronger documentation that illustrates a significant negative impact on the patient's functioning level and/or her ability to function adequately in her environment would be required.  Part of the documentation detailed test findings that were within normal limits as well as an indication of positive academic reports from her teachers.  Demonstration of medical necessity involves a higher threshold, which was not made in this particular case.  The information provided in the documentation does not make a sufficient argument for medical necessity.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Central Nervous system/other 
Treatment: Home health care
The insurer denied the Increase in Personal Care Aide (PCA) Level 2 Services:12 hours per day- 7 days per week- Total of 84 Hours per week as not medically necessary
The health plan denial is overturned in whole 

This is a patient with a past medical history of coronary artery disease, atrial fibrillation, hypertension, hyperlipidemia, diabetes mellitus type 2, renal insufficiency, breast cancer, normal pressure hydrocephalus, depression, dementia, urinary incontinence, bowel incontinence, right vestibular schwannoma, and osteoarthritis who had been assigned to receive PCA services. 
Yes, the requested service of the increase in personal care aide services is medically necessary for this patient.
The patient's internist, cardiologist, and neurologist all document the decline in the patient's functional status and document the medical necessity for increased PCA services. The patient's informal helper is no longer able to provide the same level of support due to medical issues. The patient has new bowel incontinence requiring an increase in assistance with toilet use. The patient is noted to be wheelchair-bound and not able to walk, although the assessment noted the patient to be maximal assistance for the task of walking. The patient is noted to have an informal helper but no longer does due to medical issues. The family provided a response stating that the patient is not able to perform personal hygiene and needs full assistance, is not able to use the toilet and take care of toileting needs by self, is not able to bathe self and needs full assistance, needs assistance with eating as the patient gags because the patient eats too fast due to dementia, and needs full assistance to transfer to and from a bed to chair and needs full assistance to dress up including diaper changes, bathroom visits, use of the glucometer and the blood pressure cuff.
The addition of PCA service hours is not solely for supervision and safety for assistance with ADL's (Activities of Daily Living) and IADL's (Instrumental Activities of Daily Living). Personal Care Services are medically necessary when assistance with nutritional and environmental support functions is essential to the maintenance of the patient's health and safety in her own home.
Therefore, the requested Increase in Personal Care Aide (PCA) Level 2 Services:12 hours per day- 7 days per week- A total of 84 hours per week is medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Dental infection.
Treatment:  Inpatient admission.

The insurer denied the inpatient admission.  The denial was upheld.   

This is a male child who presented to the Emergency Department (ED) with an approximately 1-2 day history of right-sided pain and 1-day history (as per mother) of right-sided facial swelling associated with a mandibular primary molar tooth.  At the time of initial examination in the ED, the dental service was contacted and consulted.  It was deemed by them that the patient's tooth, which had been endodontically treated, was the source of an infection and facial swelling.  The decision by the dental service was to extract the tooth in the ED at that time, at which point it was reported that 2 cubic centimeters (cc) of purulent discharge was noted.  The patient was placed on pain medication and intravenous (IV) clindamycin.  The patient was admitted for observation and continued antibiotic therapy.  The patient remained stable, the condition improved and he was then discharged.

Upon comprehensive review of the documentation as provided, it appears that this patient presented with an endodontically treated primary molar tooth (no radiographs were available for review), which developed a dental infection and abscess.  This prompted the patient's visit to the Emergency Department (ED).  At the time of evaluation, there was a prior history of pain, but no pain was reported at time of intake in the ED.  The patient's swelling was reported to be of one day duration, but otherwise all his vital signs were stable.  The patient received definitive treatment for an abscess of a primary tooth, by the dental service in the ED.  From the time the patient presented to the ED to the date of his discharge, the patient's vital signs remained stable.  As the patient received definitive treatment in the ED, the patient was in no acute distress.  There was no indication for hospital admission and acute level of care.  The patient could have been discharged from the ED on oral antibiotic therapy and oral pain management as necessary, with close outpatient follow up-visit.

Based on the stated clinical findings at the time of initial ED consultation, it appears that the patient's dental infection was not significant enough to justify or warrant an inpatient admission, and could have been safely managed in an outpatient setting.  Appropriate evaluation with the assessment of the patient for stability of vital signs, diagnosis of dental abscess and referral to the dental service line for further follow up as outpatient would have been sufficient.  The patient could have been discharged from the ED to seek further follow-up care in the outpatient setting with appropriate oral antibiotics and pain management.  Based on literature review and this patient's clinical presentation, inpatient admission was not medically necessary.  

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

Based on the above, the medical necessity for the inpatient hospital admission is not substantiated.  The insurer's denial should be upheld.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Lupus/Lupus Nephritis
Treatment: Pharmacy/Prescription Drugs (Benlysta)
The health plan denied the requested prescription drug. 
The health plan's determination is overturned.

This is a patient with lupus and lupus nephritis. She began Benlysta infusions with a positive response but had a lapse in treatment due to social circumstances. In terms of lupus nephritis, she is on Cellcept as well as Plaquenil. She has 'crippling joint pain', which is the reason for Benlysta as it has helped her in the past. The issue in this case is that subcutaneous (SQ) Benlysta is being denied by the health plan. The reason cited is the plan will only allow coverage if the patient does not have severe active lupus nephritis.
At issue is the medical necessity of the requested medication.

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

Yes, the requested health service/treatment of Benlysta is medically necessary for this patient.
The patient was on intravenous (IV) Benlysta before. She has debilitating joint pain and Benlysta has helped her in the past. She is now steroid dependent and requires an additional steroid sparing drug, such as Benlysta, which has helped her in the past. She is already on Plaquenil and Cellcept. Moreover, her provider suspects avascular necrosis (AVNs) in her knees, which is a steroid related adverse effect.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Right Shoulder Clavicle Fracture
Treatment: Physical Therapy
The health plan denied the request for physical therapy. 
The health plan's determination is overturned.

This case describes a female patient who sustained a right clavicle fracture.  The provider recommended conservative management of the fracture with sling immobilization. The next office visit was completed, at which time plain radiographs demonstrated that the fracture was healed. Physical examination revealed that the patient had limited external rotation and abduction indicating that the patient had adhesive capsulitis in the affected right shoulder. An magnetic resonance imaging (MRI) scan of the right shoulder was obtained which confirmed that the fracture was healed. There were findings consistent with adhesive capsulitis on the MRI scan. The provider recommended a course of supervised physical therapy to restore normal motion in this patient's right shoulder. At issue in this case is the medical necessity of the requested course of supervised physical therapy for this patient's right shoulder.

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

The requested physical therapy for this patient is medically necessary based upon the provided medical records and the current, peer-reviewed orthopedic literature.
First, the provided medical records in this case document that this patient sustained a clavicle fracture which was treated conservatively. The patient had some delay in further treatment and developed significant restriction of her shoulder motion. This was documented on an office visit. The physical examination confirmed limited external rotation and forward flexion of the shoulder consistent with adhesive capsulitis. Based on this documentation, the medical necessity of the requested supervised physical therapy is clearly established.
Second, the current, peer-reviewed orthopedic literature, including recent articles published by Redler and colleagues in the Journal of the American Academy of Orthopedic Surgeons in 2019 and by Jain and associates documented the benefits of supervised physical therapy for adhesive capsulitis of the shoulder.
The medical necessity of the requested supervised physical therapy is established based upon the provided medical records which document a frozen shoulder for this patient after conservative treatment of a non-displaced clavicle fracture. The request for supervised physical therapy for adhesive capsulitis is consistent with the recommendations of the current, peer-reviewed orthopedic literature on adhesive capsulitis. Therefore, the denial in this case is overturned and the therapy course is authorized.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Lumbosacral Degenerative Disc Disease
Treatment: Intracept Procedure
The insurer denied the Intracept Procedure.
The determination is overturned.

This is a patient with a diagnosis of low back pain. Magnetic resonance imaging (MRI) of the lumbar spine noted degenerative disc disease from type II Modic endplate changes at lumbar (L) 5-sacral (S) 1, and to a mild degree at L4-5. At issue is whether the proposed health treatment of Intracept Procedure is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

The Intracept procedure (Intraosseous Basivertebral Nerve Ablation) is likely to be more beneficial than any standard treatment or treatments for the patient's disabling condition. The patient has a long history of chronic low back pain. He has failed alternative treatment measures such as physical therapy, medications, epidural steroid injections and lumbar radiofrequency ablation. MRI Lumbar Spine noted, "degenerative disc disease from type II Modic endplate changes at lumbar (L) 5-sacral (S) 1, and to a mild degree at L4-5." While "Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain: 2-Year Results From a Prospective Randomized Double-Blind Sham-Controlled Multicenter Study" was published in an international journal, the trial was completed at 15 sites in the United States and only 3 sites in Europe. The data is clear that this procedure is safe and effective. "Using a 10-point improvement in Oswestry Disability Index (ODI), the commonly accepted minimum clinically important difference (MCID) in the treatment of chronic low back pain (CLBP), 75.6% (96/127) of treated patients exhibited a successful response at 3 months. At 24 months, this result was sustained with 76.4% (81/106) of treated patients continuing to receive clinical benefit from basivertebral nerve (BVN) ablation." The study protocol discouraged physicians from treating study patients with further spinal injections and at 24 months the patient's treated with ablation "8 (7.5%) had spinal injections performed for either new onset or continuing lower back pain (LBP), a substantial decrease from the 61 (57.5%) who had reported prior injections at baseline." Furthermore, opioid use at 12 month follow-up the patients treated with radiofrequency (RF) ablation "60.7% of the patients who were taking opioids at the time of enrollment had reduced opioid medication, with 46.4% completely eliminating the use of opioids." There were also "no device or procedure-related patient deaths, no unanticipated adverse device effects, and no device-related serious adverse events (SAEs) reported in the study." In addition, "A prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain" published in Spine Journal noted that the radiofrequency ablation arm had mean changes in Oswestry Disability Index at 3 months of -25.3 points versus -4.4 points in standard arm.

The health plan's determination is overturned.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Lumbosacral Degenerative Disc Disease
Treatment: Intracept Procedure
The insurer denied the Intracept Procedure.
The determination is upheld.

The patient was diagnosed with lumbosacral degenerative disease. He has a long history of chronic low back pain that has progressively worsened over time. The patient had previously undergone conservative management including medications, physical therapy, multiple injections including facet injections, radiofrequency ablation and epidural injections without any significant improvement. It is noted that the patient has MRI findings of type II Modic changes at lumbar (L) 4 - L5 and L5 - sacral (S) 1. The provider has recommended that the patient undergo L5 and S1 intraosseous basivertebral nerve radiofrequency ablation (Intracept procedure). At issue is whether the Intracept Procedure 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 health service or treatment 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 is noted to have chronic back pain with failure of therapy, medications and injections. Although this procedure appears to be showing some promising results, current studies remain limited without long-term follow-up periods and current studies appear to be primarily sponsored by the industry and/or small studies with limited follow-up periods. Currently, this procedure is not considered standard of care in the general medical community due to limited evidence to suggest that this treatment would be considered as effective as other standard means of treatment for chronic back pain. Standard treatment options would include additional physical therapy, chiropractic treatment, injections, medications such as nonsteroidal anti-inflammatory drugs, acetaminophen, muscle relaxants, neuropathic medications such as antidepressants or anticonvulsants and if failure to resolve, traditional surgical approaches may potentially be an option, which would require a surgical evaluation to determine appropriate surgical options.

The determination is upheld.