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

Diagnosis: Bilateral uveitis and chronic macular edema. 
Treatment: Acthar. 

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

The patient is a female with bilateral uveitis and chronic macular edema. Upon appeal, the provider reports that the patient has tried and failed topical and oral steroids as well as Remicade (infliximab) and Humira (adalimuab). Coverage was recently denied as there was no documentation of trial and failure to high dose corticosteroids as well as immunosuppressant therapies. A note documents vision as 20/70+2 OD (right eye) and 20/60 left eye (OS) while on Remicade and Prednisone (10 milligrams (mg)). 

Acthar is not medically necessary for this patient. Uveitis is usually treated with a step-wise approach using low and then high dose corticosteroids, immunosuppressive therapy, and biologics, and the records provided suggest that this patient has failed low dose corticosteroids and biologics, but not high dose corticosteroids and immunosuppressive therapy, the medical necessity of Acthar is not established in this case.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Stage 4 Pressure Ulcer.
Treatment: 4 skilled nursing visits.

The insurer denied the 4 skilled nursing visits. The determination is overturned.

The patient has a medical history notable for a stage 4 pressure ulcer, dementia, Parkinson's Disease, and hypertension. She recently received home wound care services for her sacral wound. The health plan denied coverage for 4 skilled nursing home visits, stating that the visits were not medically necessary under Milliman Care Guidelines (MCG) guidelines.

A letter of support was provided by the patient's geriatric office. The treating Medical Doctor (MD) attested that home care services were necessary for wound care for the patient.

A home skilled nursing visit note was provided for review. The patient was encountered in her home and was noted to be homebound with maximum assist for all activities of daily living (ADLs)s. Her pain was 4/10 at the site of the wound and the registered nurse (RN) assisted with pain management. Her sacral ulcer was unstageable at that visit, and routine cleansing and packing were performed by the nurse. A wound bed collagenase and gauze were applied. Skilled nursing was to evaluate the wound 3 times a week with the patient's daughter to perform wound care as instructed on other days. A follow up visit was recommended in 2 days to reassess the wound, presumably for ongoing manual cleaning.

A prior home health visit note was available for comparison. That note describes the sacral wound as "healing well, length (L) 1.2 centimeters (cm) x width (W) 0.75cm x diameter (D) 0.2cm, 100% red tissue and small amount of sanguineous drainage." They noted that the patient's daughter was competent with wound care but "states she is not comfortable with a nurse not visit to evaluate wound." The patient has 12 hours per day of a home health aide, and gets repositioned every 2 hours. She has an air mattress. At issue is the medical necessity of the 4 skilled nursing visits.

The requested health service/treatment of 4 skilled nursing visits is medically necessary for this patient. This patient has a currently unstageable (presumably stage 4 based on the history) sacral ulcer which has been under home nursing care. She will need ongoing wound care and is homebound. Her daughter has been successfully caring for the wound using collagenase and dressing changes, but based on the notes provided, there is still manual cleaning of the wound that should be completed by an appropriate professional to promote ongoing healing. This recommendation is consistent with the Wound, Ostomy and Continence Nurses (WOCN) 2016 guidelines.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Polycystic Ovary Syndrome (PCOS).
Treatment: Ozempic 0.25 or 0.5 PEN (pen) INJCTR (injector).
The insurer denied coverage for Ozempic 0.25 or 0.5 PEN INJCTR.
The denial is upheld.

The patient is a female with a history of polycystic ovary syndrome (PCOS). Treatment with Ozempic is requested. At this time no medical records have been submitted for this case. 

The management of PCOS requires treatment of individual components of the syndrome, including menstrual dysfunction and the risk of endometrial hyperplasia, hyperandrogenism (hirsutism and acne), metabolic risk factors (obesity, glucose intolerance, and dyslipidemia), and, in some women, anovulatory infertility. The choice of therapy depends upon whether the patient is pursuing pregnancy or not. 

For women with PCOS, oligomenorrhea, and chronic anovulation combined estrogen-progestin oral contraceptive (COC) therapy (Grade 2C) is recommended. The goal of COCs for these women is to prevent endometrial hyperplasia and provide contraception (as women with oligomenorrhea ovulate intermittently and unwanted pregnancy may occur). COCs are the mainstay of pharmacologic therapy for managing hyperandrogenic symptoms. For women with PCOS who choose not to or cannot take COCs, intermittent progestin therapy can be used. 

For most women with hirsutism or other androgenic manifestations such as acne or female pattern hair loss, starting with a COC (Grade 2C) is recommended. 

Weight loss (which can restore ovulatory cycles, improve metabolic risk, and possibly improve live birth rates) is the intervention for most women. 

OZEMPIC is a glucagon-like peptide 1 (GLP-1) receptor agonist indicated as: an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease. 

This patient is not known to have type 2 diabetes. While GLP-1 may have a promising therapeutic role in PCOS; larger clinical trials are needed to establish the role of incretin-based therapies in the management of PCOS. 

As of now, Ozempic for this patient is not medically necessary. This patient could use oral contraceptives or progestin therapy to regulate her menstrual cycles. The patient could use Metformin which has an established tract record in helping patients with PCOS. 

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

The insurer's denial of coverage for Ozempic 0.25 or 0.5 PEN INJCTR is upheld. Medical Necessity is not substantiated.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Back pain
Treatment: Intraosseous Basivertebral Nerve Ablation 

The insurer denied Intraosseous Basivertebral Nerve Ablation. The health plan's determination is upheld.

The patient is female with chronic back pain for greater than 20 years. The patient's complaints of (c/o) thoracic and lumbar spine pain are described as acting, burning, stabbing, sharp and shooting. The pain radiates from her thoracic spine to her chest wall and lumbar spine to her hips and buttocks. She also c/o numbness in her leg, toe, arm, hand and finger. She rates the pain between 6-8/10 most days and notes that it is exacerbated by any movement including bending forward, lifting, lying flat, rotating, sitting standing and walking. 

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.

Given this patient has failed multiple other conservative therapies, attempts at interventional pain management may benefit the patient. However, it can't be determined if standard treatments are or have been beneficial in this patient since that information was not included. The results of the epidural steroid injection (ESI) and MBB (medial branch block) are needed to determine if any improvement was gained and/or if her pain pattern changed as a result of this therapy. The magnetic resonance imaging (MRI) demonstrates facet arthropathy and her physical examination was positive which is consistent with (c/w) facet-mediated pain and her response to the MBB would be helpful to determine both diagnostically and therapeutically if in fact, that is the source of her pain.

The patient has limitations due to her chronic back pain and she had several interventions although follow-up to assess the response is not clearly delineated. She has also used muscle relaxants and tramadol to manage the pain. The requesting physician notes that the patient's pain is significant and limits ADL (activities of daily living), but there is no ODI (Oswestry disability index) score. Additionally, the MRI report notes Modic changes only at L (lumbar) 4-5. Therefore, the requested treatment is not likely to be more beneficial than standard treatment at this time.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Back pain
Treatment: Intraosseous Basivertebral Nerve Ablation 

The insurer denied Intraosseous Basivertebral Nerve Ablation. The health plan's determination is upheld.

This is a female who has a chief complaint of chronic thoracic and lumbar spine pain. She has a 20-year history of chronic pain. Her pain is aching, burning, sharp and stabbing with radiation to hips and buttocks and numbness in the leg and toes. 

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.

Intraosseous Basivertebral Nerve Ablation (Intracept system) was designed to treat low back pain from vertebral body by ablating Basivertebral nerves. The available medical records did not reveal adequate evidence that this patient's pain is from vertebral bodies. Her magnetic resonance imaging (MRI) showed broad disc extrusion at L (lumbar) 4/5 level with 6 mm caudad extension in ventral epidural space, Retrolisthesis L4 on L5 and multilevel facet joint arthropathy. Physical exam (PE) documented limited range of motion (ROM) of lumbar spine with positive facet loading tests and positive straight leg raise tests.

Given this patient's medical history, MRI findings, and the current clinical evidence, she is not an appropriate candidate for Intraosseous Basivertebral Nerve Ablation. The Intraosseous Basivertebral Nerve Ablation is unlikely to be more beneficial than any standard treatment for this patient's back pain.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Back pain
Treatment: Intraosseous Basivertebral Nerve Ablation 

The insurer denied Intraosseous Basivertebral Nerve Ablation. The health plan's determination is upheld.

The patient is a female with chronic back pain. The pain is located in the thoracic and lumbosacral spine. Pain radiates across the chest wall and low back pain radiates to the hips and buttocks. 

The proposed 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.

This procedure is not recommended despite promising early reports, and further trials with longer-term outcomes and less risk of bias are required. A 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: Hidradenitis
Treatment: Humira
The insurer denied Humira.
The health plan's determination is upheld.

The patient is a female with hidradenitis, Hurley stage 3, treated with intralesional Kenalog, topical Clindamycin, oral Doxycycline and Rifampin. The provider is requesting Humira.

Humira is not medically necessary for this patient.
Hidradenitis suppurativa/acne inversa (HS/AI) is a chronic, painful, inflammatory skin disorder characterized by the development of inflammatory nodules, pustules, sinus tracts, and scars, primarily in intertriginous areas. Current treatment recommendations are:
- Patients with Hurley stage I HS/AI present with single or multiple nodules and abscesses without associated sinus tracts or scarring. Daily treatment of the involved areas with topical clindamycin is recommended with a topical antiseptic wash can also be used for showering, and intralesional corticosteroids or punch excisions.
- Patients with Hurley stage II HS/AI exhibit recurrent inflamed nodules and abscesses, some of which lead to sinus tracts and scarring. Treatment includes continuation of preventive, plus medical and surgical, therapy. For the medical treatment of the inflammatory component of Hurley stage II disease, oral tetracyclines are recommended for first-line therapy. Combination therapy with clindamycin and rifampin can be helpful for suppurative disease unresponsive to oral tetracyclines. Acitretin and antiandrogenic agents may also provide benefit. The sinus tracts of Hurley stage II HS/AI will not resolve with antibiotic therapy and may require surgical deroofing (unroofing) if they are recurrently inflamed.
- Hurley stage III HS/AI is characterized by diffuse or nearly diffuse involvement of the affected area (intertriginous or not) with fluctuant nodules, interconnecting sinus tracts, and extensive scarring. For the nonsurgical treatment of Hurley stage III HS/AI that cannot be managed with oral antibiotics, oral retinoids, or hormonal therapy, Humira/adalimumab is recommended as the next-line therapy.
- For patients with severe HS/AI in a localized area that has failed to respond sufficiently to medical therapy and limited surgical therapy (eg, deroofing), extensive surgical excision offers the best chance to provide permanent relief.
Therefore, Humira is not medically necessary at this time as the patient has not failed oral antibiotics, oral retinoids, or hormonal therapy.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's Disease.
Treatment: Stelara 90 milligrams (mg) /milliliter (ml) every (Q) 4 weeks.
The insurer denied: Stelara 90 mg/ml every 4 weeks.
The denial is overturned.

This male patient has severe ileocolonic Crohn's disease. He has previously tried and failed an immunomodulator (azathioprine) and an anti-tumor necrosis factor (TNF) agent (adalimumab). He was started on Stelara and did well initially on Stelara at standard dosing every 8 weeks but recently lost response. He had evidence of active inflammation on colonoscopy. Hence the attending provider is requesting the use of Stelara at the escalated dose of 90 milligrams (mg) subcutaneously (SC) every 4 weeks to treat this patient's severe Crohn's disease.

The proposed health service or treatment Stelara 90 milligram per milliliter (mg/ml) every 4 weeks is likely to be more beneficial than any standard treatment or treatments for the patient's disease.

Since this patient was not responding to standard dosing of Stelara, it is reasonable to increase the dose of Stelara to 90mg every 4 weeks. Dose escalation in biologic therapy used in inflammatory bowel disease can be done either based on clinical symptoms or laboratory markers or endoscopic or radiological features with or without therapeutic drug monitoring. Dose escalation is done either by increasing the dose of the medication or shortening the interval between doses or sometimes a combination of both. There are only a finite number of biological agents used to treat inflammatory bowel disease and the standard of care is to optimize dose of the biological agent before switching to another agent. Therefore, it is appropriate to use Stelara 90mg SC every 4 weeks to treat this patient's severe Crohn's disease.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's Disease.
Treatment: Stelara 90 milligrams (mg) /milliliter (ml) every (Q) 4 weeks.
The insurer denied: Stelara 90 mg/ml every 4 weeks.
The denial is overturned.

The patient is a male with Crohn's disease (CD) status post ileocecectomy complicated by fistulas requiring ileostomy. He has failed sulfasalazine, mesalamine, and Humira. The patient had been on Stelara every eight weeks. Colonoscopy showed active enteritis in the neo-terminal ileum and anastomosis with pseudopolyps. The subject under review is whether the treatment with Stelara 90 milligrams (mg) every four weeks is likely to be more beneficial for this patient than any standard treatment for his Crohn's disease.

Current medical literature supports dose escalation of Stelara to 90 mg every 4 weeks is likely to be more beneficial than any standard treatment or treatments for the patient's Crohn's disease. A large randomized controlled trial demonstrated safety and efficacy for induction and maintenance of remission in patients with moderate-severe Crohn's disease that was resistant to anti-tumor necrosis factor (TNF) therapy (Sandborn, et al.).
In this case, the patient had active disease on colonoscopy while taking Stelara every 8 weeks. Continuation of dosing every 8 weeks or discontinuation of Stelara (even if an alternative is attempted immediately) may result in complications such as stricture (especially where disease is active, at the anastomosis), fistula, bowel obstruction, flare, hospitalization, need for surgery, or other complications. For these reasons, Stelara 90 mg every 4 weeks is supported as likely to be more beneficial than any standard treatment or treatments for the patient's Crohn's disease.

Peer reviewed literature supports the requested dose, showing that Stelara 90 mg every 4 weeks is safe and results in outcomes superior to standard Food and Drug Administration (FDA) dosing (90 mg every 8 weeks).
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's Disease.
Treatment: Stelara 90 milligrams (mg) /milliliter (ml) every (Q) 4 weeks.
The insurer denied: Stelara 90 mg/ml every 4 weeks.
The denial is overturned.

The patient is a male under management for Crohn's Disease (CD). In the remote past the patient had an ileocolonic resection with ostomy that was reversed. The patient did not respond to Azathioprine monotherapy, Humira, or mesalamine products. He had a colonoscopy which showed severely active colitis and ileitis and was started on Stelara after this procedure along with low dose Azathioprine. A recent colonoscopy apparently showed improved inflammation although it was not fully resolved. The patient feels well.
Because of residual active inflammation on colonoscopy the patient's provider has requested approval for Stelara 90 milligrams (mg) subcutaneous (SQ) every (Q) 4 weeks. This request was denied by the plan which considers this dose to be experimental/investigational.

The proposed treatment is likely to be more beneficial for this patient than any standard treatment. This patient has aggressive underlying disease and recent colonoscopy demonstrates ongoing luminal disease. The patient is at significantly increased risk for requiring further surgery and hospitalization. In many patients, Q 4 week dosing is superior to Q 8 week dosing for ustekinumab, which is related to achieving optimal drug levels. An additional major factor is that this patient does not have an obvious next drug of choice for treatment. Because of that he is at high risk for going on to steroids which would entail short and long term side effects.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: rhabdomyolysis
Treatment: Inpatient stay
The insurer denied the inpatient stay. The health plan's determination is overturned.

This case involves a male with asthma who came into the hospital complaining of 2 days of arm pain. The pain started after an exercise activity, especially in the upper extremities. The day before this presentation, the patient started noticing a darkening of the urine and worsening pain. He also complained of sore throat with cough and scant sputum. The patient denied any wheezing or shortness of breath and no chest pain. The patient was admitted for acute rhabdomyolysis without renal damage. 

The inpatient hospital admission was medically necessary. While the patient did not experience acute kidney injury resulting from the severe rhabdomyolysis, the creatine kinase levels were persistently elevated, in the 40-50,000 range, for 72 hours, exceeding observation care criteria. The patient has concurrent edema of the upper extremity muscle groups, which requires monitoring for compartment syndrome development. Without continuous intravenous fluids, at a high rate, the risk of acute renal failure, acidosis, worsening pain, and mental status alteration is very high. It is difficult to achieve the level of needed hydration with oral fluids alone and in this type of situation. Therefore, an inpatient setting with aggressive IV fluids was indicated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Maxillary fracture 

Treatment is an inpatient admission 

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

Per clinical documentation, the patient presented to the emergency department (ED) four days after an assault to the face. The patient had a past medical history of diabetes and substance abuse. The patient was noted to be hyperglycemic but there was no evidence of diabetic ketoacidosis (DKA). The patient had a CT (computed tomography) face scan that indicated a transverse fracture through the anterior body of the right maxilla with an overlying hematoma. Plastic surgery was consulted. Per the ED notes "spoke to plastics, does not require surgical management at this time. Reports stable for discharge and follow up for outpatient operative management." The plastic surgery notes by the resident on documented that the patient "may require operative intervention during this admission once medically optimized." There is no indication of the need for an urgent procedure. The patient left against medical advice. The patient did not meet criteria for an inpatient admission. Observation care would have been appropriate for this patient. 

Patients with stable facial fractures without associated complications may be discharged from the emergency room and scheduled for operative intervention as an elective outpatient. There has been no difference in complication rates between patients who have immediate surgical repair versus patients with delayed repair after 72 hours. [1] In a recent systematic review, Stone et al found that 15 of 20 studies did not recommend earlier treatment of mandibular fractures. [2]

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for the inpatient admission services is not substantiated.