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

Diagnosis: Sickle Cell Syndrome

Treatment: inpatient admission 

The insurer denied coverage for an inpatient admission.

 
The medical records indicate that the patient had a diagnosis of asthma and sickle cell syndrome and presented to the emergency room (ER) with pain. He was noted to be febrile and was given dilaudid and intravenous (IV) fluids and was admitted. 

The patient had a diagnosis of sickle cell syndrome and was admitted to the hospital due to pain. For individuals with hemoglobin sickle cell disease with Vaso-occlusive Crisis (VOC) and fever, acute level care is warranted. Fever is one of the symptoms of sickle cell VOC that would justify an acute level of care for evaluation and management.      

"Sickle cell disease (SCD) is a group of inherited red blood cell disorders affecting about 1 in 500 African American children and 1 in 36,000 Hispanic American children. SCD results in anemia and "sickle cell crisis" (SCC). The main clinical feature of sickle cell disease is the ''acute painful crisis,'' which often requires hospitalization." (Borhade, M. B., & Kondamudi, N. P. 2022).

"Sickle cell anemia (SCA) is the consequence of abnormal hemoglobin production due to an inherited point mutation in the globin gene. The resulting hemoglobin tetramer is poorly soluble when deoxygenated, and when this is prolonged, intracellular gelation of sickle hemoglobin occurs, followed by hemoglobin polymerization. If many cycles of sickling and unsickling occur, the red cell membrane will be disrupted leading to hemolysis and vaso-occlusive events". (Piccin A, et al., 2019).

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for the inpatient admission is substantiated.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low back pain

Treatment: intraosseous basivertebral nerve ablation (procedure codes 64628 and 64629)

The insurer denied coverage for intraosseous basivertebral nerve ablation (procedure codes 64628 and 64629)

The denial is upheld

This patient has chronic low back pain (CLBP). She has tried physical therapy (PT) and a Home exercise program. She takes cyclobenzaprine and Mobic for pain.  She had an Epidural Steroid Injection (ESI). Her magnetic resonance imaging (MRI) shows Modic Type I changes at lumbar (L)4, L5 and sacral (S)1. The request is for radiofrequency (RF) ablation of the basivertebral nerves (BVN) at L4, L5 and S1.	

The publications to date have been company sponsored and had methodology flaws. There is no published data on long term complication rates. There are other evidence- based interventions available to this patient. This procedure is unlikely to be more beneficial than the standard approaches.

Conger et al pointed out that all of the major studies while supportive, have been funded by the company:

"There is moderate-quality evidence that suggests this procedure is effective in reducing pain and disability in patients with chronic low back pain who are selected based on type 1 or 2 Modic changes, among other inclusion and exclusion criteria used in the published literature to date. Success of the procedure appears to be dependent on effective targeting of the BVN. Non-industry funded high-quality, large prospective studies are needed to confirm these findings."

Peer reviewed literature does not support a result of improvement in health outcomes with the requested procedure. The requested procedure does have final regulatory approval from the appropriate regulatory bodies for this diagnosis.

This patient is not a good candidate for the requested procedure.  It is not the best available treatment for this patient at this time.

The denial of  intraosseous basivertebral nerve ablation (procedure codes 64628 and 64629) and coverage for the requested service should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are substantially increased over standard treatments.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis:  Dermatitis.
Treatment:  Adbry.

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

The patient is a male with atopic dermatitis (AD). He has failed tacrolimus ointment, betamethasone ointment, and triamcinolone ointment. He has also tried Opzelura. He has been prescribed the non-formulary drug Adbry for treatment.

The health plan's determination is upheld in whole.

The non-formulary drug being denied is not clinically appropriate for the patient's condition.

Based on the evidence-based literature, the drug Adbry is not medically appropriate. According to the American Academy of Dermatology Atopic Dermatitis Clinical Guidelines and dermatology literature, the generic medicines such as methotrexate are effective treatments for the management of atopic dermatitis [1, 2].

Within the peer-reviewed literature, in 2018, Gerbens et al. writes "methotrexate (MTX) and azathioprine (AZA) seem to be effective and safe as maintenance treatments in moderate to severe AD up to 5 years" [3]. Shah et al 2018 writes "Methotrexate is an effective treatment for moderate to severe atopic dermatitis with an acceptable safety profile. A low dose can be used to control the disease for prolonged periods without significant risk" [4]. There are several published studies that show that methotrexate is effective and safe for moderate-severe atopic dermatitis [5-8]. The evidence-based literature is consistent. There are no unique clinical circumstances to this particular individual that would make Adbry medically necessary or appropriate. The patient has no true contraindications to the use of the preferred generic medication. The preferred standard of care agents, such as methotrexate, are appropriate agents for the treatment of the patient's atopic dermatitis. Therefore, Adbry is not medically appropriate for this patient.
Appeal type: Formulary Exception
Decision: Upheld

The health plan denied Adbry as a formulary exception. The health plan's determination is upheld.

The patient is a male with atopic dermatitis (AD). He has failed tacrolimus ointment, betamethasone ointment, and triamcinolone ointment. He has also tried Opzelura. He has been prescribed the non-formulary drug Adbry for treatment.

The health plan's determination is upheld in whole.

The non-formulary drug being denied is not clinically appropriate for the patient's condition.

Based on the evidence-based literature, the drug Adbry is not medically appropriate. According to the American Academy of Dermatology Atopic Dermatitis Clinical Guidelines and dermatology literature, the generic medicines such as methotrexate are effective treatments for the management of atopic dermatitis [1, 2].

Within the peer-reviewed literature, in 2018, Gerbens et al writes "methotrexate (MTX) and azathioprine (AZA) seem to be effective and safe as maintenance treatments in moderate to severe AD up to 5 years" [3]. Shah et al 2018 writes "Methotrexate is an effective treatment for moderate to severe atopic dermatitis with an acceptable safety profile. A low dose can be used to control the disease for prolonged periods without significant risk" [4]. There are several published studies that show that methotrexate is effective and safe for moderate-severe atopic dermatitis [5-8]. The evidence-based literature is consistent. There are no unique clinical circumstances to this particular individual that would make Adbry medically necessary or appropriate. The patient has no true contraindications to the use of the preferred generic medication. The preferred standard of care agents, such as methotrexate, are appropriate agents for the treatment of the patient's atopic dermatitis. Therefore, Adbry is not medically appropriate for this patient.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Nonalcoholic steatohepatitis
Treatment: Ozempic
The insurer denied coverage for Ozempic
The denial is overturned.
 
The patient has a diagnosis of nonalcoholic steatohepatitis (NASH). She also has metabolic syndrome and hepatic fibrosis. Her hepatologist has advised taking Ozempic which she has been on for several months. The physician states that at this time there are no Food and Drug Administration (FDA) approved treatments for her condition. However, he has cited references in the scientific literature that support the use of semaglutide for NASH.

The New England Journal of Medicine 2021; 384:1113-1124 has an article titled "A Placebo Controlled Trial of Subcutaneous Semaglutide in Nonalcoholic Steatohepatitis." This was a 72-week study involving 320 patients with biopsy proven NASH and liver fibrosis who were given various doses of semaglutide vs placebo. The conclusion of the study was that treatment of these NASH patients with semaglutide resulted in a significantly higher percentage of patients with NASH resolution as compared to placebo. The fibrosis stage did not reverse but the NASH was resolved without worsening of the fibrosis score.

This patient has NASH with a mutation of the APO-B (apolipoprotein) gene. Her physician writes that she already has had a positive response to the Ozempic treatment. If this condition is left untreated there is a high likelihood of developing cirrhosis and eventual death. The New England Journal article has shown that semaglutide is able to result in resolution of NASH in a high percentage of patients. Since there is a peer reviewed placebo-controlled trial showing the benefits of semaglutide in NASH patients, the health care plan did not act in the best interest of the patient.

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for Ozempic for treatment of nonalcoholic steatohepatitis is substantiated.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's disease.
Treatment: Humira 80 milligrams (mg) weekly.
The insurer denied Humira 80 mg weekly.
The health plan's determination is overturned.

The patient is a male with small bowel and colonic Crohn's disease complicated by perianal fistula, seronegative arthropathy, pyoderma gangrenosum under his ostomy stoma, and fistula at the ostomy site. He has failed mesalamine, budesonide, 6-mercaptopurine, methotrexate, Remicade, Cimzia, and Entyvio. He was in remission on Humira 80 milligrams (mg) every 2 weeks with Stelara, but had to stop Stelara; he subsequently had development of a peristomal fistula and associated pain.

Humira 80 mg weekly is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

Current medical literature supports dose escalation to address loss of response while on Humira. In the CHARM (Crohn's Trial of the Fully Human Antibody Humira for Remission Maintenance) trial, which was a high-quality phase III randomized double-blind placebo-controlled trial 56-week study, a significant percentage (27% [percent] of open-label patients) required dose escalation with weekly dosing. Dose escalation achieved remission at higher rates in patients with active disease. The remission rate with dose escalation has been reported at 46.9% versus 22.5% when dosing every other week. This is a common therapeutic strategy. In severe Crohn's disease treated at a referral center, the rate of dose escalation was reported at 45%. Double-dose weekly therapy (80 mg weekly) has been reported as safe and effective in patients who have lost response to weekly therapy. Dose escalation of Humira beyond 40 mg every two weeks has proven safe and effective in randomized controlled trials and retrospective studies.

In the CLASSIC-II trial, 60 of 204 open-label patients required increase in dosing to every week. Additionally, American College of Gastroenterology guidelines for the treatment of Crohn's disease state that "Those with continued symptoms should have their medication dose adjusted in order to attempt to optimize therapy", and American Gastroenterological Association guidelines for therapeutic drug monitoring recommend increase in dose if necessary.

In this case, the patient had control of symptoms with Humira 80 mg every 2 weeks with Stelara, until Stelara was stopped; continued dosing of 80 mg every two weeks could result in complications of disease activity, such as disease flare, recurrent fistula, need for surgery again, or hospitalization. For these reasons, medical literature supports the use of Humira 80 mg weekly as likely to be more beneficial than any standard treatment or treatments for the treatment of the insured's Crohn's disease.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's disease.
Treatment: Humira 80 milligrams (mg) weekly.
The insurer denied Humira 80 mg weekly.
The health plan's determination is upheld. 

The patient is a male with Crohn's Disease. The patient was being treated with Humira, 80 milligrams (mg) every other week for Crohn's and seronegative spondyloarthropathy. The patient has small and large bowel Crohn's with a history of perianal disease. At one point, he was on Humira and ustekinumab at the same time which was effective but ustekinumab was stopped as it was not covered by insurance. He has pyoderma under an ostomy which has worsened after stopping ustekinumab. He also looks like he is developing a fistula at the ostomy site as well. The patient has previously failed other anti-tumor necrosis factor (TNF) therapy and Entyvio.

Humira 80 mg weekly is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

It is extremely unusual for a patient to be prescribed a dose of Humira this high which is basically 4 times the normal maintenance dose. Treatment at these doses has not been carefully reviewed and the case series submitted by the provider is of low quality. The main issue is that there is no data presented from office notes on the patient's adalimumab drug level and antibody level. For example, if the drug level is already very high or there is the presence of high titer antibodies to adalimumab, there is no logical reason to dose escalate. Adalimumab drug and antibody data need to be ascertained. Additionally, adding an immune modulator such as azathioprine is another option for management.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's disease.
Treatment: Humira 80 milligrams (mg) weekly.
The insurer denied Humira 80 mg weekly.
The health plan's determination is overturned. 

The patient is a male who has severe ileocolonic Crohn's disease. He has previously tried and failed 5-ASA (5-aminosalicylic acid) agents, steroids, and two anti tumor necrosis factor (TNF) agents (infliximab and certolizumab) as well as an anti-integrin agent (vedolizumab). He was started on Humira at standard dosing and did not achieve remission. His dose of Humira was increased to 80 milligrams (mg) and Stelara was added. 

Humira 80 mg weekly is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

Dose escalation in biological therapy used to treat inflammatory bowel disease is a well accepted practice and supported by literature in patients who are not responding to standard dosing of the medication. 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 current biological agent before switching to another agent.

Therefore, Humira dose escalation to 80 mg weekly in this patient who failed standard and initial escalated dosing of Humira is appropriate.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Atopic Neurodermatitis
treatment: Dupilumab (Dupixent)
The insurer denied Dupilumab (Dupixent). The health plan's determination is upheld.

The patient is a female with severe atopic dermatitis (50% body surface area involvement, EASI (eczema area severity index) 45, IGA (immunoglobulin A) of 3) of the upper trunk, upper extremities, face, neck, and scalp. The patient has tried and failed triamcinolone, clobetasol, hydrocortisone, Elidel, and Protopic, as well as oral prednisone and phototherapy. The patient has been on Dupixent with 80% improvement while on Dupixent.

Dupilumab (Dupixent) is not medically necessary for this patient.
The patient has no documented treatment failure with, or true medical contraindication to, either of the standard, first-line oral medications used for moderate to severe atopic dermatitis (such as Methotrexate, Azathioprine, or Mycophenolate Mofetil). Dupixent is not proven to be superior to all other formulary alternatives as per comparative, controlled studies.
Modern dermatology literature supports use of the preferred medications as similarly efficacious to the requested Dupixent, particularly for a patient with a limited history of other forms of systemic atopic dermatitis therapy previously utilized, and recommend use of these preferred agents as appropriate for this patient's clinical scenario. Therefore, as per current medical standards of care, Dupixent is not medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Esophageal carcinoma
Treatment: Continued Inpatient Hospital Admission
The insurer denied the continued inpatient hospital admission.
The denial is overturned.

The patient is an adult male who had an esophagectomy for esophageal carcinoma. His postoperative status was complicated by anastomotic leak, jejunostomy tube malfunction requiring bowel resection. He had to have mediastinal drain placement. The anastomotic leak was treated with stenting. Eventually, the perforation healed, and bowel function returned. The patient was able to tolerate PO (oral) diet and was discharged.

The continued inpatient hospital admission was medically necessary.

The patient had an esophagectomy with postoperative complications of anastomotic leak and malfunctioning of the jejunostomy tube requiring bowel resection. These major problems were adequately managed but require inpatient stay due to the intensity of the treatment required and constant monitoring. The patient also required drainage of mediastinal abscess with indwelling drain and TPN (Total Parenteral Nutrition) support.

The inpatient stay was medically necessary due to the above-described reasons.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Diabetic neuropathy

Treatment:  Lidocaine patch 5%

The insurer denied coverage for Lidocaine patch 5%

The denial is overturned

 
The patient has a history of diabetes, neuropathy, and gastroparesis. She has a gastric pacemaker in place. She was diagnosed with neuropathic pain around the gastric pacemaker area. She has reported that Lidoderm has provided relief. 

Up To Date has an article titled "Management of diabetic neuropathy." The article discusses topical therapies. Lidocaine patches are listed as a treatment for this condition and advises that the patch can improve the pain of diabetic neuropathy. An article is referenced from Archives of Neurology 2004;61 (6):914 titled "Effectiveness, Tolerability, and impact of quality of life of the 5% lidocaine patch in diabetic polyneuropathy." The conclusion was that these patches are well tolerated, significantly improve pain and quality of life ratings, and may allow tapering of concomitant analgesic therapy. 

The insurance company has denied the Lidocaine patch stating that the pain was not neuropathic. However, the physician has documented that the patient has neuropathic pain as a complication from her diabetes. In view of the diagnosis of diabetic neuropathic pain and the benefit that the patient has received from the Lidocaine patch, giving the patch is medically necessary. 

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Lidocaine 5% patch is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Maxillary sinus cyst. 
Treatment: Ambulatory surgery (sinus surgery 31267x 1). 
The insurer denied: Ambulatory surgery (sinus surgery 31267x 1). 
The denial is upheld. 

The patient is an adult male with a reported maxillary sinus cyst. The only clinical document is a physician appeal letter. No computed tomography scan is presented. No sinus symptoms are described. Maxillary antrostomy is under review. 

The proposed treatment was not medically necessary. 

There are a lack of documents describing the medical necessity of this procedure. Maxillary cysts usually do not need surgery unless they are producing sinus obstruction causing chronic or recurrent acute sinusitis. While the physician states there is obstruction in this patient, there were no other sinus symptoms described.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Urinary tract infection
Treatment: Inpatient admission
The insurer denied coverage for inpatient admission.
The denial is overturned.

This patient presented to the emergency room with elevated white blood cell count (WBC), left shift in white cells, low blood pressure (BP), tachycardia and signs and symptoms of early sepsis. The patient is a known diabetic and the patient's glucose was greater than 500. There were clinical findings suggestive of sepsis. In a diabetic, sepsis does require hospital admission and it was anticipated that the patient would require a stay longer than 48 hours based on the lactate level, need for fluid resuscitation and need for intravenous (IV) antibiotics. It was noted that her renal function was compromised with a creatine level of 1.5. The patient did meet the InterQual criteria for admission based on sepsis, positive blood cultures, significant left shift of her white cells and the need for diabetic teaching for a glucose over 500. The denial of admission is overturned.

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient.

The medical necessity for inpatient admission is substantiated.