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

Diagnosis: Pain in right knee
Treatment: Inpatient Hospital Admission
The insurer denied: Inpatient Hospital Admission
The denial is upheld.

This is an adult female with a painful right knee. She was diagnosed with osteoarthritis. Admission to hospital and surgery were performed. The patient's past medical history was significant for hypertension, obesity, and status post bariatric surgery. She was American Society of Anesthesiologists (ASA) class 3. Her post-surgical course was complicated by a fall in blood pressure at physical therapy (PT). She received intravenous fluids. She was discharged on day number 3 (#3).

The requested health service was not medically necessary.

The medical records showed a non-complicated post-surgical course. There was no evidence of bleeding. There were no problems with the wound. No drain was placed. Ambulation with physical therapy was satisfactory with the exception of one episode of hypotension. Blood pressure improved to 140 over 80 (140/80) and the patient was asked to walk again. She was able to tolerate oral pain medication. There was no need to treat other underlying medical conditions. 
Note - the discharge summary was completed on day #2. The medical record of the date of surgery - post-surgery states: "dispo home when cleared by PT". There were no extenuating circumstances to warrant admission at such level. Therefore, the requested health service was not medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Breast Cancer
Treatment:  Proton Beam Radiation Therapy
The insurer denied Proton Beam Radiation Therapy
The determination is overturned.

This is a female patient who presented with left (L) breast cancer. The patient was treated with chemotherapy followed by a mastectomy. She was recommended adjuvant radiation using proton beam. At issue is the medical necessity of the proton beam therapy.
The requested treatment is medically necessary for this patient.
This is a young patient with curable disease on the L side. The attending provider (AP) has provided dose volume histogram (DVH) comparison of proton beam therapy (PBT) and intensity modulated radiation therapy (IMRT).
The mean heart dose from IMRT is 8.5 gray (Gy) compared to .85 Gy from PBT. This is a Quantec violation from dose of IMRT. Reducing the heart dose will avoid cardiac morbidity and mortality in this young woman with curable disease. Lung V5 [radiation dosing parameter] from PBT is 39 percent (%) from PBT compared to 87% from IMRT. Lung V20 from PBT is 19% compared to 37% from IMRT. Thus, PBT will reduce lung morbidity. PBT reduces radiation to the opposite lung thus avoids another malignancy. PBT reduces second malignancy compared to IMRT.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Insomnia
Treatment: Belsomra
The insurer denied Belsomra.
The health plan's determination is overturned.

This is a female patient who was prescribed Belsomra (suvorexant). Diagnoses included insomnia (unspecified), opioid dependence, sedative, hypnotic or anxiolytic dependence, alcohol dependence, palpitations, menopausal and female climacteric states. The health plan declined the claim as not medically necessary based on the clinical guideline. The patient reportedly failed over-the-counter melatonin. The appeal note indicates that Ambien is contraindicated, relative to opioid and sedative dependence.

Clinical records show that the patient also failed doxepin. She was taking long-acting buprenorphine. At issue is the medication Belsomra.

The patient would not be a candidate for use of zolpidem given that she is on opioids and benzodiazepines. Failure of melatonin would likely coincide with failure to respond to ramelteon given the mechanism of action of this drug. Therefore, based on the provided clinical information, the patient would be less likely to have benefit from the formulary drugs than the recommended nonformulary drug Belsomra (suvorexant).
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Chronic Pain Syndrome.
Treatment: Oxycontin.
The insurer denied Oxycontin.
The determination is upheld.

This is a male patient being prescribed Oxycontin for the treatment of chronic pain syndrome. The health plan denied coverage for the requested medication because it is not on the plan formulary. They require a trial of formulary alternatives with documented adverse reactions or contraindications. Formulary alternatives available to treat chronic pain include fentanyl transdermal, hydrocodone extended release, hydromorphone extended release, methadone, morphine extended release, oxycodone extended release, Nucynta extended release, and Xtampza extended-release.
Office visit notes were provided for review. They stated that the patient was using Xtampza but had inadequate pain relief. He was also having issues with constipation and resulting urinary retention. He had previously used Oxycontin and was requesting to switch back to that. He uses over-the-counter medications like Tylenol and Motrin for initial pain management. He also has an allergy to hydrocodone. The patient's wife provided a letter as part of this appeal. The letter states that the patient did very well on the requested medication Oxycontin in the past. He did not do well on Xtampa as previously reported. The letter states he has also tried fentanyl patches, Butrans patches, hydrocodone, and morphine.  There was no information provided regarding why the brand name Oxycontin is medically necessary for the patient. At issue is whether the formulary drug will be or has been ineffective, would not be as effective as the non-formulary drug, or would have adverse effects.
There is insufficient evidence that the formulary drug options will be ineffective or would be less effective than the requested non-formulary drug. There is no evidence that the formulary drugs would all have adverse effects.
There are numerous opioid medication options available on the patient's formulary. Notably, among these options is extended-release oxycodone, which is a generic for the requested medication. There is no documented trial or intolerance of the generic alternative of the requested drug. There are also several other options available to the patient.
Appeal type: Medical necessity
Decision: Overturned

 Diagnosis: Severe Eosinophilic Asthma. 
Treatment: Dupixent. 
The insurer denied coverage for Dupixent. 
The denial is overturned. 

This is an adult with a history of severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis (EGPA) with migratory ground glass infiltrates on computed tomography (CT). The patient had been treated with high dose steroids in the past and was switched to mepolizumab for this condition. The patient was also diagnosed to have asthma and was maintained on Advair, DuoNebs and Budesonide Nebs. The patient was also on systemic steroids. The patient has required multiple courses of steroids for their asthma break through. The patient 's asthma is of the eosinophilic type and the patient also had elevated fractional exhaled nitric oxide (FeNO) levels. Since this patient was experiencing asthma exacerbations despite being on multiple medications which included inhaled corticosteroids (ICS), long-acting beta agonists (LABA), anticholinergic agents, oral steroids and mepolizumab (Nucala), it was decided to start the patient on Dupixent. 

Dupixent is a monoclonal antibody that inhibits interleukin (IL) 4 and IL 13 and is specifically indicated for patients with eosinophilic asthma. 

The patient was being treated with mepolizumab (Nucala) for his EGPA. This medication is specifically indicated for this condition. 

These two drugs (Dupixent and Nucala) act on different pathways; one on IL4, IL13 (Dupixent) and the other on IL5 (Nucala). There have been studies that have shown that multiple biologics appear to be well-tolerated. 

This patient has severe asthma and severe EGPA. These conditions were not controlled on the patient's current regimen. The 2 medications proposed, Nucala and Dupixent have specific interleukin pathways they target and there have been studies to show that they can be both used simultaneously to target the different pathways. Based on inability to control this patient's symptoms on the current regimen and having 2 specific drugs that target the patient's 2 conditions of severe eosinophilic asthma and EGPA, it is appropriate to use Dupixent; Dupixent is medically necessary for this patient. 

Based on the above, the insurer's denial must be reversed. 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 Dupixent is substantiated.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Constipation

Treatment: Motegrity (prucalopride)

The insurer denied coverage for Motegrity (prucalopride)

The denial is overturned

 
The patient has been seeing a gastroenterologist since 2010 for chronic constipation. He was initially treated with Metamucil and Miralax. Studies and anorectal manometry revealed delayed colonic transit time and dyssynergia. Diet modifications and biofeedback were tried. He was subsequently treated with Lactulose and Linzess. He did not respond well to these medications and his physician has now advised Motegrity. In view of the slow colon transit time and abnormal motility studies, it was advised that he would benefit most from Motegrity. 

UpToDate has an article titled "Management of chronic constipation in adults." The article discusses pharmacologic treatment. There are several choices of medications including linaclotide and plecanatide which are guanylate cyclase-C receptor agonists, lubiprostone which is a locally acting chloride channel activator, and prucalopride which is a prokinetic agent. Prucalopride has been shown to be superior to placebo in clinical trials and was safe and well tolerated. Improvement in the quality-of-life scores was maintained up to 18 months. 

This patient has chronic constipation with abnormal colonic transit time and an abnormal anal motility testing. He has already failed the formulary alternative of Linzess as well as several other laxative regimens. Prucalopride works by stimulating colonic peristalsis which then increases bowel motility. This treatment would be a good option for this patient. In view of the transit and manometry studies, prucalopride would likely be more beneficial than the formulary alternatives. 
The denial is reversed.

The formulary drugs are not expected to cause adverse effects. 

The formulary drugs were tried in part, and the patient did not have an adverse reaction or contraindication.

The formulary drug(s) is expected to be ineffective.

The non- formulary drug is expected to be more effective than the formulary alternatives.

The carrier's denial of a request for a Formulary Exception for Motegrity (prucalopride) to treat constipation is reversed.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Coronary Artery Disease
Treatment: Home Healthcare
The insurer denied Personal Care Worker (PCW) Services for 84 hours per week (7 days x 12 hours, a total of 84 hours per week).  
The denial was overturned. 

This is a female patient with a history of coronary artery disease, hypertension, hyperlipidemia, diabetes with retinopathy and decreased vision, cognitive impairment, hard of hearing, dizziness, recurrent falls, osteoporosis, chronic debilitating pain due to right hip post-traumatic osteoarthritis, and urinary incontinence. She lives alone and has durable medical equipment at home: a straight cane, rolling walker, walker-rollator, shower chair, grab bar, handheld shower, raised toilet seat, incontinence supplies, and a personal emergency response system (PERS). 

Personal Care Worker (PCW) Services: 12 hours per day, 7 days per week; a total of 84 hours per week was medically necessary.
Documentation in the recent Uniform Assessment System (UAS) shows the patient requires extensive assistance with transferring to the toilet, using the toilet, walking, and locomotion. As a result, the patient has unscheduled and unpredictable care needs that span a continuum of time, and the Plan failed to document a plan to meet these needs. The Plan should not have used a tasking tool to calculate hours as it did not account for the patient's assistance with unscheduled and unpredictable care needs. The patient's primary care provider (PCP) has documented the medical necessity of increased PCW services. The patient lives alone and lacks informal support for the entire time outside of the previously assigned hours. The patient's care needs cannot be met solely with adaptive equipment and medical supplies. The requested increase in PCW services is not exclusively for safety and supervision but to assist the patient with activities of daily living (ADL).
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: diabetes
Treatment: inpatient stay
The insurer denied the inpatient stay
The health plan's determination is upheld.

This is a case of a female admitted for diagnosis of new onset diabetes mellitus associated with diabetic ketoacidosis. The patient presented with chief complaint of polyuria and polydipsia. Labs showed blood sugar greater than 500 with anion gap of 17. Vital signs demonstrated temperature 97.3F, pulse 88, respiratory rate 18, blood pressure 125/82 and O2 (oxygen) saturation 98%. Physical exam showed no acute distress or altered mental status. 

The inpatient hospital admission was not medically necessary. Although the patient had a mild case of diabetic ketoacidosis, she would not require admission as her serum bicarbonate was not less than 15. She did not have a potential hydrogen (pH) less than 7.3, hypotension, altered mental status, acute kidney injury, persistent dehydration, inability to have oral intake, significant electrolyte abnormalities, persistent hyperglycemia, or a cause of diabetic ketoacidosis requiring additional therapy such as infection. She had new onset diabetes requiring treatment with insulin and Januvia. Her hyperglycemia then resolved and on the day of discharge she had a glucose of 123. A lower level of care was appropriate.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Psoriasis. 
Treatment: Tremfya. 
The insurer denied coverage for Tremfya. 
The denial is upheld.  

The patient is an adult female with a diagnosis of Psoriasis.  The patient has failed only topical therapy with topical steroids. The request is for Tremfya. 

Based on the submitted documentation, the use of Tremfya in this clinical scenario is not medically necessary. The patient has tried and failed only topical therapies. There are no contraindications to any of a multitude of formulary systemic agents, including biologics Cimzia, Humira, Skyrizi, and Stelara. Any of these is a reasonable systemic treatment for this patient and within the standard of care for treatment of psoriasis. There are no absolute contraindications noted which would necessitate the use of Tremfya or make Tremfya a more reasonable medical treatment option. The use of Tremfya over formulary alternatives is not considered medically necessary. The appeal is upheld based on the submitted documentation. 

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 Tremfya injections 100 milligrams per milliliter (mg/ml) (1 per 28 days) is not substantiated.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Seizures
Treatment: Keppra
The insurer denied Keppra.
The determination is overturned.

This is a male patient with seizures secondary to X-linked adrenoleukodystrophy. Treatment with a Keppra is the subject of this review. The drug was denied by the plan as the medication is nonformulary. At issue is whether the non-formulary drug being denied is clinically appropriate for the patient's condition.

In this instance, the patient has epilepsy secondary to a genetic brain condition, X-linked adrenoleukodystrophy. Based on the labeling of the drug Keppra, this medication is indicated for treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. The patient has generalized seizures and is stable on the requested medication. The records also suggest that the patient has tried and failed the generic equivalent. As such, Keppra is medically indicated for treatment of the member's condition.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Gastroesophageal reflux disease

Treatment: Omeprazole-sodium bicarbonate powder

The insurer denied coverage for Omeprazole-sodium bicarbonate powder

The denial is upheld 

Patient is a male child with a past medical history notable for Cornelia de Lange, developmental delay, behavioral issues and gastroesophageal reflux disease. He was prescribed omeprazole capsules but was chewing the beads negating the enteric coating protection of the medication affecting its efficacy. His treating gastroenterologist is requesting a formulary exception for omeprazole-sodium bicarbonate powder rather than any of the formulary delayed release capsule forms.

The insurer is denying coverage for omeprazole-sodium bicarbonate powder since the patient has not tried and failed at least 3 of the preferred formulary alternatives including: dexlansoprazole delayed-rel (generic Dexilant), esomeprazole delayed-rel, lansoprazole delayed-rel, omeprazole delayed-rel, or pantoprazole delayed-rel.

The issues to be addressed are whether the denial was appropriate and whether this agent is the best choice for this patient.

According to the insurer's policy:
The requested drug will be covered with prior authorization when the following criteria are met: 

.	The patient cannot be switched to a formulary drug
AND
.	The patient is unable to take the required number of formulary alternatives for the given diagnosis due to a trial and inadequate treatment response or intolerance, or a contraindication. Documentation is required for approval
AND
.	The requested drug is being used for an [Food and Drug Administration] FDA-approved indication or an indication supported in the compendia of current literature (examples: Micromedex, current accepted guidelines) 
AND
.	The prescribed dose and quantity fall within the FDA-approved labeling or within dosing guidelines found in the compendia of current literature

Given this patient's developmental issues, he is unable to ingest the pellets without chewing after opening the omeprazole capsules and mixing with food or liquid. There are other proton pump inhibitors (PPIs) such as lansoprazole capsule that can be opened and contains granules that may be better tolerated and should be tried before granting a formulary exception. 

Uphold denial of formulary exception for omeprazole-sodium bicarbonate powder.

The formulary drugs are not expected to cause adverse effects. 

The formulary drugs were not tried, and the patient did not have an adverse reaction or contraindication.

The formulary drug is not expected to be ineffective

The non- formulary drug is not expected to be more effective than the formulary alternatives.

The carrier's denial of a request for a Formulary Exception for Omeprazole-sodium bicarbonate powder is upheld.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Meningioma

Treatment: Everolimus 10 milligram (mg) tablet

The insurer denied coverage for Everolimus 10 milligram (mg) tablet

The denial is overturned
 

This is an adult female who was seen by her doctor for her Avastin and Sandostatin treatment. The treating provider noted that the addition of Everolimus was discussed, and the patient agreed to that. The last imaging showed an interval increase in the tumor. The patient has been on chemotherapy since with no worsening or improvement in the patient's symptoms. In the assessment, the treating provider noted the grade three (3) meningioma encompassing bilateral cavernous sinus, the plan was to continue with Avastin and Sandostatin, and the plan was to add Everolimus. The treating provider noted that the patient was not a candidate for radiation therapy and that the patient's tumor was growing rapidly in size. The patient had cavernous meningioma which was resected and had radiation therapy. The patient had tumor debulking and chiasm decompression, the patient was treated with Avastin and Sandostatin as she was not a candidate for surgery or radiation. The treating provider has requested therapy with Everolimus 10 milligram (mg) tablet daily, which is under review.

"Treatment for recurrent and aggressive meningiomas remains an unmet medical need in neuro-oncology, and chemotherapy exhibits limited clinical activity, if any. Merlin expression, encoded by the NF2 (Neurofibromatosis) gene, is lost in a majority of meningiomas, and merlin is a negative regulator of mTORC1 (Mammalian target of rapamycin). The sst2 (somatostatin) receptor, targeted by octreotide, is highly expressed in meningiomas. To investigate new therapeutic strategies, we evaluated the activity of everolimus (mTOR inhibitor), BKM-120 (mTOR inhibitor/ Buparlisib) and BEZ-235 (new Pi3K (Phosphatidylinositol 3-kinase)/Akt/mTOR inhibitors/Dactolisib), octreotide and a combined treatment (octreotide plus everolimus), on cell proliferation, signaling pathways, and cell cycle proteins, respectively."(Graillon T, et al 2015)

"The combination of everolimus and octreotide was associated with clinical and radiological activity in aggressive meningiomas and warrants further studies. Decrease in the tumor volume growth rate should be considered a complementary and sensitive endpoint to select potentially effective drugs for recurrent meningiomas."(Graillon T, et al 2020)

The patient should be offered every possible treatment that can stop the progression of this recurrent meningioma that is putting what is left of her vision at risk especially since the patient is not a candidate for surgery or radiation therapy.      

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 Everolimus 10 milligram (mg) tablet is substantiated.