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

Diagnosis: Cardiac/Circulatory Problems 
Treatment: Pharmacy/Prescription Drugs - Eliquis 
The insurer denied Eliquis. 
The denial is upheld.

The patient is a male with a history of chronic heart failure with preserved ejection fraction (EF), aortic valve stenosis, paroxysmal atrial fibrillation, peripheral arterial disease (PAD), hypertension, hyperlipidemia, and diabetes mellitus. Records indicate that this patient has been treated with Eliquis for the last 2 years for prevention of stroke and has done well. The patient's health plan has denied prescription benefit exception request for Eliquis on the grounds that prescription benefit exception criteria have not been met given lack of documentation for failure, intolerance, or contraindication to the alternative anticoagulants, warfarin and Xarelto. The patient's treating physician is appealing the denial for prescription benefit coverage exception for Eliquis.

The health plan's decision is upheld.

Based on review of records provided for this case, this patient does not meet the health plan's criteria for prescription benefit exception for Eliquis because there has not been documentation stating that all of the formulary anticoagulants, warfarin and Xarelto, would be less effective and/or contraindicated for this patient for the prevention of stroke in this patient with atrial fibrillation. Furthermore, peer reviewed medical literature and expert consensus guideline statements on anticoagulation management in patients with atrial fibrillation indicate that Xarelto would be an appropriate anticoagulant in this case. (1,2)
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Malocclusion

Treatment: D8080 braces

The insurer denied coverage for D8080 braces

The denial is upheld

Upon review of the submitted documentation including lateral cephalometric radiograph, panoramic radiograph, montage of extraoral and intraoral clinical images, as well as insurer correspondence, it appears that this patient presented for evaluation for orthodontic care. The orthodontist identified several clinical findings including mandibular protrusion, open bite and anterior crowding and has recommended orthodontics. The orthodontist has completed the Handicapping Labio-Lingual Deviation (HLD) index attaining 24 total points to support orthodontic care. 

It is evident that the patient exhibits a malocclusion. However, to assess for severity of the malocclusion and therefore medical/dental necessity for orthodontic care, an HLD index is utilized. This index provides six specific conditions that automatically qualify for orthodontic care. Additional criteria are used utilizing a point system if none of these initial qualifying conditions are met or selected. For these other secondary criteria to qualify for orthodontic care a total score of 26 points is necessary.

In this case, the treating orthodontist does not claim an automatic qualifying condition and completes the second portion of the index arriving at 24 points to justify orthodontic care. This reviewer concurs with the index completed by the orthodontist attaining a total of 24 points on the HLD index which is below the threshold of 26 points to support orthodontic care. Of note in this case, is that the patient's own orthodontist does not attain 26 points on the HLD index as required for orthodontic approval.

Regarding the validity of the Handicapping Labiolingual Index, it has been shown through scientific scrutiny in peer reviewed journals that this methodology for assessing orthodontic need is a valid approach. This is confirmed by several studies referenced below.

Each of these peer reviewed articles concludes that this index is a valid and reliable determinant of need for orthodontic care. As this is an accepted methodology, this has been determined to represent an appropriate approach for assessing orthodontic need.

The clinical circumstance as presented does not substantiate the medical/dental necessity of orthodontic care as it does not meet the accepted criteria for approval.

In this case the patient's own orthodontist completed HLD index total score of 24 points remains below the threshold of 26 points to justify orthodontic care.

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

The insurer's denial of coverage for D8080 braces is upheld. Medical Necessity is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Genitourinary/Kidney Disorder. 
Treatment: Inpatient Hospital. 
The insurer denied inpatient stay. 
The denial is upheld.

The patient is a male with a history of diabetes mellitus (DM), hypertension (HTN), hyperlipidemia and known left staghorn calculus who presented for surgical intervention. He had a computed tomography (CT) scan which showed left renal parenchymal atrophy, a large left staghorn calculus, a mid to upper pole calculus, a left lower power calyceal rim calculus and a normal right kidney with punctate stones.
Vitals showed that he was afebrile with blood pressure of 125/72, a pulse of 92, a respiratory rate of 14 and a room air pulse oximetry of 99%. Labs showed a white blood cell (WBC) count of 17.7, a hemoglobin of 14.1, and a creatinine of 1.17. He underwent an uncomplicated percutaneous left lithotripsy with ureteral stent insertion. He was noticed to be persistently tachycardic with an elevated blood pressure and fluctuating respiration rates, he was admitted for further management and a workup was negative for deep vein thrombosis (DVT) and pulmonary embolism (PE). An electrocardiogram (EKG) showed sinus tachycardia. The creatinine increased to 1.43 but returned quickly to baseline with IVF. He continued to do well and was discharged in stable condition with follow in one week with urology for stent removal.
The subject under review is the medial necessity for an inpatient stay.

The inpatient stay is not medically necessary based on the documentation provided. The patient presented for an outpatient surgical procedure for his known left staghorn calculi. He did not have bilateral ureteral obstruction or unilateral obstruction of a solitary or transplant kidney. He did not have acute kidney injury; He did not have a documented complicated urinary tract infection. He tolerated the procedure well. He did have some sinus tachycardia post procedure, in addition to leukocytosis and a transient increase in his serum creatinine, but none of these conditions necessitate an inpatient admission. He could have been managed at a lower level of care status.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Respiratory Distress

Treatment inpatient admission

The insurer denied coverage for inpatient admission

The denial is upheld

The patient presented to the Emergency Room (ER) after 2 days of fever, dry cough, sore throat, decreased oral intake, and vomiting. She was ill-appearing, with bilaterally diffuse rhonchi and wheezing. ER Vital signs were notable for a fever up to 38.4 C (Celsius) and tachycardia up to 143, but respiratory rates were not >20/min and oxygen saturations (SpO2) were 98-99% (percent) on room air. X ray was consistent with viral pneumonia with the presence of faint infiltrates, all other lab values were normal. 

The reviewer agrees with the insurer that the admission was not medically necessary. There is no documentation in ER attending attestation notes, or in the vital signs records, that she did not respond to treatment in the ER with DuoNeb doses and dexamethasone. Vital signs were notable for a fever up to 38.4 C and tachycardia up to 143, however, respiratory rates did not exceed 20/min and oxygen saturations were 98-99% on room air. The pediatric admitting history and physical describes a comfortable child.

The patient did not meet criteria for admission for pneumonia (UpToDate, Barson et al), which include:

-Hypoxemia (peripheral capillary oxygen saturation [SpO2] <90 percent)
Dehydration 
-Moderate to severe respiratory distress: Respiratory rate >50 breaths per minute for        older children; retractions; nasal flaring; difficulty breathing; apnea; grunting
Toxic appearance
-Underlying conditions that may predispose to a more serious course of pneumonia (e.g., cardiopulmonary disease, genetic syndromes, neurocognitive disorders, (e.g., immunocompromised host)
-Complications (e.g., effusion/empyema, necrotizing process, abscess)
-Suspicion or confirmation that the pneumonia is due to a pathogen with increased virulence, such as Staphylococcus aureus or group A Streptococcus (GAS)
-Failure of outpatient therapy (worsening or no response in 48 to 72 hours)
-Recurrence of pneumonia 
-Age younger than 8 weeks. 

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

The insurer's denial of coverage for the inpatient admission is upheld. Medical Necessity is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Hydronephrosis
Treatment: Inpatient hospital admission

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

This is a male with a history of multiple childhood febrile urinary tract infections (UTIs), and asthma. The patient complained of lower back pain for several months. The patient was transferred from outside hospital (OSH) after presenting with lower abdominal pain and vomiting for 2 days. Computed tomography (CT) scan at OSH showed moderate to severe right hydronephrosis. The patient was transferred, admitted, started on intravenous (IV) fluids, IV antibiotics, and famotidine. He was seen by Urology, who recommended outpatient surgery for correction of the right hydronephrosis likely due to right ureteropelvic junction (UPJ) obstruction. This was scheduled. The patient's condition improved. He tolerated a regular diet and was discharged.

The insurer has denied coverage for the inpatient hospital admission as not medically necessary. They noted there was no documentation of failure to improve after observation care. There is no record of infection, decreased immunity, uncontrolled bleeding, or a urinary blockage that did not improve after observation treatment. The patient's care could have been rendered in the emergency room or in observation area. The appeal on behalf of the hospital is noted and read in detail. 

Per MCG (Milliman Care Guidelines) Health (25th) Urologic Disease, the patient fails to meet clinical indications for admission to inpatient care. The patient also fails to meet clinical indications for inpatient care admission for MCG Health (25th) Abdominal pain, undiagnosed RRG.

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

Diagnosis: Chronic low back pain and spondylosis

Treatment: Transforaminal epidural steroid injection

The insurer denied coverage for transforaminal epidural steroid injection

The denial is overturned

This adult gentleman has chronic low back pain and spondylosis. He presented to the Pain Management physician's office for the evaluation of back pain. Pain was rated at a level of 7 out of 10. The patient had an epidural steroid injection. He reported more than 80 percent (%) relief and more than 50% improvement in functions such as walking for more than two months. The physician recommended repeating the epidural steroid injection.

Clinical practice guidelines (1) support repeating this procedure.

Suchy et al (2) reviewed the indications for repeat Epidural steroid injection and 80% pain relief as well as 50% continuing pain relief for 2 months are valid indications to repeat the block. Helm et al (3) conducted a systematic review and meta-analysis and concluded: "There is Level I evidence for the use of transforaminal injections for radicular pain from disc herniations." This procedure is medically reasonable and necessary for this patient.

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

The insurer's denial of coverage for transforaminal epidural steroid injections is overturned. Medical Necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Severe Atopic Dermatitis

Treatment Dupixent 300 milligrams (mg)/ 2 milliliters (ml) subcutaneous (SC) solution pen injector (SOPN)

The insurer denied coverage for Dupixent 300 milligrams (mg)/ 2 milliliters (ml) subcutaneous (SC) solution pen injector (SOPN)

The denial is overturned

The patient is an adult female with a history of severe atopic dermatitis and pruritus. The patient has failed topical steroid therapy with clobetasol and other steroids as well as non-steroidal therapy with Eucrisa and tacrolimus. The patient is unable to tolerate confined spaces required for total body UV (ultraviolet) therapy as a result of her claustrophobia. The requested medication is Dupixent. 

The patient has a diagnosis of severe atopic dermatitis which would be amenable to systemic therapy. Underlying claustrophobia prevents the use of 3 times per week phototherapy. Methotrexate would normally be an option for systemic treatment. However, a review of the provided medical documentation indicates that she may be at increased risk of hepatic disease due to chronic alcohol consumption. Importantly, a review of the patient's medical history and current medications indicates that she is taking Naproxen 500 mg (milligram) tablets. Naproxen increases levels of methotrexate by reducing drug clearance through the kidneys and can lead to potentially toxic level of methotrexate. In addition, as per Up to Date states, "Dupilumab - We suggest dupilumab, rather than conventional immunosuppressant agents, for patients with moderate to severe disease unresponsive to topical therapy alone for whom phototherapy is not feasible or acceptable." 

As such, the use of Dupixent for the treatment of severe atopic dermatitis is medically necessary based on the clinical scenario and the documentation provided. 

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 Formulary Exception for Dupixent 300 milligrams (mg)/ 2 milliliters (ml) subcutaneous (SC) solution pen injector (SOPN) to treat atopic dermatitis is overturned. Medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Respiratory
Pharmacy/prescription drugs

Diagnosis: Cystic Fibrosis
Treatment: Orkambi
The insurer denied Orkambi. The health plan's determination is upheld. 

The patient is a female with CF (cystic fibrosis). Under review is Orkambi 100-125 milligrams (mg). The patient's medical history includes Cystic Fibrosis. Newborn screen was positive, with elevated IRT (immunoreactive trypsinogen) and homozygous for the F508del mutation in the CFTR (Cystic fibrosis transmembrane conductance regulator) gene. Sweat test was positive. According to the clinic note, the patient is thriving, has excellent weight gain, had a normal chest x-ray, and had no symptoms or labs suggestive of pancreatic insufficiency. A Clinic note also states that the patient is still doing well. The prescribing physician stated that the goal of the medication is to prevent onset of pancreatic insufficiency.

Orkambi 100-125 mg is not medically necessary for this patient. It is not FDA approved for use in this age (children under 2) and there is no data in the medical literature that it is safe or effective in this age. In the appeal letter, the prescribing physician states that there is a clinical trial demonstrating the safety of the medication in this age group, however, this trial has not been published yet. A search of the National Library of Medicine using PubMed search engine did not show that there are any publications about this medication in this age group.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Restless Leg Syndrome.
Treatment: Formulary exception for Ropinirole ER 2mg Tablet, Pre-service.
The insurer denied the Formulary exception for Ropinirole ER 2mg Tablet, Pre-service.  The denial is upheld.

The patient is a male with restless leg syndrome (RLS). He has tried and failed Horizant and gabapentin. The provider is requesting ropinirole ER (extended release) noting improvement with treatment.

No, the health plan should not cover the Formulary exception for Ropinirole extended release.

There is no documented reason the patient cannot be treated with the preferred ropinirole immediate release. The preferred medication has the same exact mechanism of action and is FDA (United States Food and Drug Administration)-indicated for the treatment of RLS (restless leg syndrome) (Winkelmann et al.). There are no clinical trials or standard of care guidelines to support the superiority or preferential use of ropinirole ER (extended release) relative to ropinirole IR (immediate release) for this patient's condition.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Pulmonary Embolism (PE)

Treatment: Eliquis

The insurer denied coverage for Eliquis

The denial is overturned.

The patient has a history of hereditary hemochromatosis, hyperlipidemia, acute Pulmonary Embolism. The patient has been treated with Eliquis for his pulmonary embolism (PE). He had been stable on Eliquis (a direct oral anticoagulants [DOAC]) for 2 years. The patient was switched to Xarelto due to change in his insurance formulary. He developed a severe allergic reaction to Xarelto with hives. The patient required to be treated with Benadryl and Medrol Pack for treatment of same.

This patient has a contraindication to Xarelto due to severe allergic reaction. The 2 drugs in the approved formulary are Xarelto and Warfarin. There is no other substitute other than Xarelto in the same class (DOAC). Warfarin is in a different class and not suitable for the patient due to need for frequent blood draws and drug interactions.

Based on review of records and above Eliquis should be reinstituted. DOAC would be preferred over Warfarin in this patient due to less side effects such as bleeding, better tolerability and less drug-to-drug interaction and no requirement of frequent blood testing.

The preferred drug is likely to be more effective that the formulary drugs.

The insurer's denial of coverage for Formulary Exception for Eliquis is overturned.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Multiple Myeloma; Back pain. 
Treatment: Formulary exception Oxycontin (oxycodone ER). 

The insurer denied the Formulary exception Oxycontin (oxycodone ER). 
The denial is overturned. 

The patient is a male with chronic pain secondary to cancer related pain (multiple myeloma). He has been prescribed OxyContin. Coverage for this was denied by the health plan as the patient has not failed 3 formulary alternatives. These include fentanyl transdermal QL/PA (quantity limits/prior authorization), hydrocodone extended release, hydromorphone extended release , methadone,  morphine extended release, oxycodone extended release, Nucynta extended release, and Xtampza ER (extended release). This has been appealed.  The patient has been on this medication for many years, and this is a continuation of treatment. 

Yes, the health plan should cover the Formulary exception. 

The patient is a male with chronic pain secondary to cancer related pain (multiple myeloma). He has been prescribed OxyContin. Coverage for this was denied by the health plan, as the patient has not failed 3 formulary alternatives. These include fentanyl transdermal QL/PA (quantity limit/prior authorization), hydrocodone extended release, hydromorphone extended release, methadone, morphine extended release, oxycodone extended release, Nucynta extended release, and Xtampza ER (extended release). This has been appealed.  The patient has been on this medication for 11 years, and this is a continuation of treatment. 

Despite this being a continuation of treatment, the patient did trial one of the formulary alternatives without benefit. Therefore, while the patient has been stable on this regimen, they have still tried an alternative and was not successful.  His quality of life has been impaired according to the attached documentation. There is no data to support advantages of the formulary alternative in malignancy related pain.  Discontinuation of the patient's regimen can lead to increased pain, poor quality of life, and difficulty in re-establishing reasonable pain control. Given the above, the requested formulary exception is medically appropriate.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Glaucoma. 
Treatment: Current Procedural Terminology (CPT) code 66174, transluminal dilation of aqueous outflow canal; without retention of device or stent. 

The insurer denied coverage for CPT code 66174, transluminal dilation of aqueous outflow canal; without retention of device or stent. 

The denial is overturned. 

This case involves a patient with a history of glaucoma and diabetes.  The patient was seen for complaints of not being able to see out of the right eye.  The patient reported that his vision was much worse than before.  Everything was darker.  He stated that it was difficult to function and difficult to drive.  His poor vision was affecting his activities of daily living.  He was status post selective laser trabeculoplasty of each eye a few years ago.  The exam of the patient noted 3+ nuclear sclerosis cataract of the right eye.  The intraocular pressure of the right eye was 24 in the left eye was 18.  The patient was diagnosed with primary open-angle glaucoma, bilateral severe stage, and age-related nuclear cataract, bilateral.  The patient had very decreased vision, but this was likely due to retinal issues.  The patient was aware of limited postoperative potential.  The patient has been treated with pars plana vitrectomy with oil.  A recommendation was noted for viscocanalostomy. 

The ophthalmologist provided references to support the treatment for the patient.  Viscocanalostomy had been performed when there was high risk of complications and when medical therapy had failed to adequately control the intraocular pressure.  It was imperative that the patient be well treated to prevent loss of visual field and vision. 

Additional research has identified that viscocanalostomy and phaco-viscocanalostomy have been shown to achieve significant intraocular pressure reduction and visual improvement in patients with open angle glaucoma. 

In this case, the patient was at risk for blindness due to glaucoma.  The patient had tried and failed standard treatments for glaucoma.  Standard laser therapy was completed. Given the patient's ongoing symptoms, failure of standard treatments for glaucoma, and references noting the benefit of the requested treatment, proceeding with the CPT code 66174, transluminal dilation of aqueous outflow canal; without retention of device or stent is likely to be more beneficial than any other standard services without increased risk. 

The carrier's denial of current procedural terminology (CPT) code 66174, transluminal dilation of aqueous outflow canal; without retention of device or stent be overturned.