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

Diagnosis: Central Nervous System/Neuromuscular Disorder
Treatment: Pharmacy/Prescriptions Drug
The insurer denied Sodium Phenylbutyrate. 
The health plan's determination is overturned.

The patient is a male with amyotrophic lateral sclerosis. Treatment with sodium phenylbutyrate is the subject of this review. The plan denied this medication because the member does not have a urea cycle disorder.

The health plan's determination is overturned.

There is no formulary alternative identified for treatment of amyotrophic lateral sclerosis (ALS). The requested drug sodium phenylbutyrate has been shown to be safe and effective to slow the progression of ALS and increases survival.
An orally administered, fixed-dose co-formulation of sodium phenylbutyrate-taurursodiol (PB-TURSO) significantly slowed functional decline in a randomized, placebo-controlled, phase 2 trial in ALS (CENTAUR). Herein we report results of a long-term survival analysis of participants in CENTAUR. In CENTAUR, adults with ALS were randomized 2:1 to PB-TURSO or placebo. Participants completing the 6-month (24-week) randomized phase were eligible to receive PB-TURSO in the open-label extension. An all-cause mortality analysis (35-month maximum follow-up post-randomization) incorporated all randomized participants. Participants and site investigators were blinded to treatment assignments through the duration of follow-up of this analysis. Vital status was obtained for 135 of 137 participants originally randomized in CENTAUR. Median overall survival was 25.0 months among participants originally randomized to PB-TURSO and 18.5 months among those originally randomized to placebo (hazard ratio, 0.56; 95% confidence interval, 0.34-0.92; probability [P] = .023). Initiation of PB-TURSO treatment at baseline resulted in a 6.5-month longer median survival as compared with placebo.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Shortness of breath. 
Treatment: Inpatient Hospital Stay. 
The insurer denied the Inpatient Hospital Stay. 
The determination is overturned. 


The patient is a former smoker who stopped many years ago, with a history of hyperlipidemia and positive coronovirus disease (COVID) antibodies, who presented with increasing shortness of breath. A computed tomography (CT) scan showed a partly solid ground glass opacity in the right lung apex that measured 1.4 centimeters (cm) x 1.4 cm with a .5 cm x .6 cm solid component. A fine needle aspiration (FNA) was suspicious for malignancy. A positron emission tomography (PET) scan showed a fludeoxyglucose (FDG) avid lesion in the right upper lobe (RUL) (standard uptake value [SUV] of 1.2) corresponding with the lesion that was biopsied. The patient was taken to the operating room and underwent a flexible bronchoscopy and right video-assisted thoracoscopic surgery (VATS) resection of the RUL lesion with a Level 4 dissection of the lymph nodes. A frozen section revealed adenocarcinoma with a negative margin. An epidural catheter was in place to help with pain management. The patient had an arterial line, Foley catheter, and chest tube in place postoperatively. The patient had pain, was nauseous, and short of breath. She improved and was discharged with follow-up. The inpatient stay was denied and is under review for medical necessity.

The requested health service/treatment of inpatient stay is medically necessary for this patient. Moderate-severe postoperative pain following VATS is not rare - the incidence of moderate-severe pain is 12.7% within the first 24 hours and 15.6% within the first 48 hours after surgery. Postoperative analgesia is a necessary part of the anesthetic plan. Per the Milliman Care Guidelines (MCG) Health Inpatient and Surgical Care 24th Edition Thoracotomy with Biopsy or Miscellaneous Procedures by Video-Assisted Thoracic Surgery (VATS), the patient meets the clinical indications for the procedure which is indicated for one or more of the following: Thoracoscopic lung or pleural biopsy for diagnosis of 1 or more of the following: pulmonary lesion. The goal length of stay is ambulatory or 2 days postoperative. Pain management was the major issue in this patient. The patient had an epidural in place for pain management and could not be discharged with an epidural in place. Medications were adjusted and the patient was discharged (2 days postoperative). This is an acceptable time course post procedure per the MCG Health Inpatient and Surgical Care 24th Edition. The requested health service/treatment of inpatient stay was medically necessary for this patient.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crossbite
Treatment: D8080 Braces; D8670 Monthly Visit x12, Pre-service
The insurer denied the D8080 Braces; D8670 Monthly Visit x12, Pre-service
The denial is overturned.

The patient is a male. The request is for orthodontic benefits.

Yes, the braces and visits are medically necessary.
The patient has an anterior tooth in crossbite with gingival attachment loss (tooth #22, lower left canine). This is an automatic qualifying condition for orthodontic benefits, according to the Salzmann Handicapping Index Scale.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Dry eye syndrome
Treatment: Pharmacy/Prescription Drugs
The insurer denied Xiidra. 
The denial is upheld.

The patient is a male with history of dry eye syndrome. The patient was treated with punctual plugs as well as Refresh tears and Systane complete. The patient was given Xiidra samples that provided him with relief.

The subject under review is whether the formulary drug may be as effective as the non-formulary drug.  

The health plan's determination is upheld.

The formulary drug Restasis has not been tried in this patient. The patient has received a trial of Xiidra and found relief with this, along with over the counter artificial tears. Restasis could be tried in this patient to see if relief of the dry eyes would be similar to that of Xiidra. There has been a question if Restasis can be used if the patient has punctual plugs and the answer is yes. Restasis can be used in the presence of punctual plugs.

This patient was found to benefit from Xiidra eye drops when used as a sample. However, the patient was never tried on Restasis eye drops which is on formulary and may provide the same relief. The patient should be given a trial or prescription of Restasis to see if this formulary drug works in his case.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Metastatic Lung Cancer
Treatment: AR1690313 New Century Health Regimen (pembrolizumab and pemetrexed), Pre-service
The insurer denied the AR1690313 New Century Health Regimen (pembrolizumab and pemetrexed), Pre-service.
The denial is overturned.

The patient is a female with non-small cell lung cancer (NSCLC).  She was diagnosed with squamous-cell carcinoma (SCC) of the lung and then had metastatic disease.  She was found to have an adenocarcinoma the following year and biopsy proven metastasis a year later.  The patient was on Keytruda in the past, then gemcitabine plus docetaxel, then Alimta plus Abraxane plus Keytruda.  The physician has now proposed therapy with Alimta plus Keytruda.  The physician states that the patient's squamous-cell carcinoma is stable on Keytruda and he is using Alimta to treat the adenocarcinoma of the lung.

Yes, the proposed treatment is medically necessary.

Per the physician, this patient has both a metastatic squamous-cell carcinoma of the lung that is controlled on Keytruda and metastatic adenocarcinoma of the lung that is progressing.  The use of ongoing Keytruda to treat the squamous-cell carcinoma of the lung is reasonable with the addition of Alimta to treat the progressive metastatic adenocarcinoma of the lung.  

Alimta is approved to treat metastatic adenocarcinoma of the lung in a second-plus line setting.  Given the presence of two distinct disease processes being treated, the squamous-cell carcinoma of the lung with Keytruda, and the adenocarcinoma with Alimta is reasonable.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Sacral fractures
Treatment: Continued Subacute Rehabilitative Services
The insurer denied Continued Subacute Rehabilitative Services. 
The health plan's determination is overturned. 

The patient is a female admitted after presenting to the emergency department with bilateral lower extremity numbness, low back pain and request for assistance with alcohol detoxification. Imaging revealed non-displaced fractures of bilateral sacral ala S1-S3 (sacral vertebra) with transverse fracture into sacral body at the S2-S3 level. Imaging also noted minimally displaced and impacted fracture of the left pubic body. Also noted was moderate lumbar spondylosis with moderate canal and advanced bilateral foramina stenosis. Orthopedic surgery was consulted and she was treated with non-operative management. She was also diagnosed and treated for a urinary tract infection and received Clinical Institute Withdrawal Assessment (CIWA) protocol for alcohol withdrawal.

The patient was discharged to a subacute rehabilitation facility. Under review is continued subacute rehabilitation services.

The continued subacute rehabilitation services are medically necessary for this patient. The patient had multiple fractures of the pelvis in addition to degenerative changes of the lumbar spine with associated back and leg pain. She has continued to require both as needed (PRN) ibuprofen 800 milligrams (mg) and dilaudid 2 mg. She has progressed with ambulation and transfers but still needs stair training to allow her to safely discharge home.

Upon reviewing all the documentation, it is clear that the patient has been making functional progress in a very reasonable amount of time. For example, the therapy noted that the patient was ambulating 10 feet wheeled walker (WW) MINA (minimum assistance) and required MINA for bed mobility and transfers. Then, the patient was noted to perform transfers with contact guard assist (CGA). She "ambulates 6 feet w/ r/walker (with/rolling/walker), CGA," and then she quickly progressed to "amp 100 feet w/r/walker, CGA, and w/c (wheelchair) follow." Despite the above, both the hospital and the subacute rehabilitation noted that the patient lived alone, in a 2 story home, with bedroom and bathroom on the 2nd floor. She also had multiple steps to enter the home (therapy in hospital noted 8 and subacute noted 12). I did not find any stair training. Therefore, the patient requires a continued stay to safely practice stair training prior to discharge to lower level of care.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Respiratory System/Pneumonia
Treatment: Inpatient Hospital
The health plan denied the requested acute care facility admission as not medically necessary. 
The health plan's determination is overturned.

This is a male who contracted COVID 19 pneumonia, eventually leading to respiratory failure requiring prolonged mechanical ventilation and tracheostomy. He was eventually liberated from the ventilator and discharged to a skilled nursing facility. He presented to the Emergency Room again for worsening respiratory distress and again needed to be placed on a ventilator. He has required ventilatory support since several months ago with ongoing pressure support trials during the day. This hospitalization has been complicated by pneumothoraces requiring chest tubes, pneumonia with multi-drug resistant organisms, and a decubitus ulcer that has led to osteomyelitis. A long-term acute care (LTAC) admission is being requested for ventilator weaning, intravenous antibiotics, and wound care.

I overturn, in whole, the health plan's determination of medical necessity.

Yes, the LTAC admission is medically necessary for this patient. The patient has now been on the ventilator since admission. He has a tracheostomy that is in place. All underlying processes have been stabilized. His pneumothoraces have been addressed with chest tubes. His infections have been addressed with appropriate and ongoing antibiotic courses. He is ventilator dependent currently but is making attempts at weaning and he seems to have some spontaneous breathing with adequate inspiratory effort. He is otherwise hemodynamically and neurologically stable, but does require daily nursing, respiratory therapy, and physician services.

This is a patient who is best suited for long term acute care. All acute processes have been stabilized. However, he still requires acute care for his ventilator weaning and wound care for his decubitus ulcer.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Peptic Ulcer
Treatment: Carafate suspension
The insurer denied the Carafate suspension.
The determination is overturned.

The patient has a peptic ulcer. Per the physician attestation for external appeal, she has failed sucralfate tablets. Coverage is requested for sucralfate suspension for the treatment of peptic ulcer. At issue is whether the formulary drug sucralfate tablet will be or has been ineffective, would not be as effective as the non-formulary drug, sucralfate suspension or would have adverse effects.

The request for sucralfate suspension is supported. Sucralfate is effective for the treatment of peptic ulcer disease [1-4]. Sucralfate is available in tablet and liquid suspension forms. Sucralfate and Carafate tablets are associated with the same indications and adverse side effects, although the patient has reportedly failed the tablet form of sucralfate. Per the physician attestation for external appeal, she has failed sucralfate tablets. No other records were provided. Therefore, the request for sucralfate suspension is supported for the treatment of peptic ulcer in this case.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Mild maxillary and mandibular crowding.
Treatment: D8080 Braces, Pre-service.
The insurer denied the D8080 Braces, Pre-service.
The denial is upheld. 

The patient is a female.  The request is for orthodontic benefits. The patient has class I canine and molar relationships. She has mild maxillary and mandibular crowding (not moderate as the provider states). She does not have anterior open bite (as the provider states).

Note - the provide states the handicapping index scale is 26; the Health plan states the index is seven.

No, the proposed treatment is not medically necessary.

Per the dental standard of care, the patient has not reached the 26 point threshold for treatment to be considered medically necessary at this time.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Ulnar Plate Fracture.
Treatment: Inpatient Hospital Stay.
The insurer denied the Inpatient Hospital Stay.
The determination is upheld.

The patient was diagnosed with ulnar plate failure. Per the appeal letter  the patient had displacement of hardware and a fracture which needed to be treated urgently due to the risk of laceration of the surrounding neurovascular structures from the displaced hardware. The comorbidities include disability, as the patient is deaf; therefore, all aspects of care require increased resource utilization and what is typically a 23 hour inpatient/observation type procedure required an extended stay to ensure that the patient understood and would comply with postoperative protocols. Additionally, the patient's pain required intravenous (IV) pain medication to manage the severe pain.
The patient presented to the emergency department after experiencing increased pain to the right forearm after jerking while sleeping. The surgical history was pertinent for a recent (25 days postoperative) surgical fixation of a right Galeazzi and midshaft ulna fracture. The pain was rated 7/10 and was associated with swelling. The x-rays confirmed the presence of plate failure of the distal aspect of the ulnar plate. The patient had undergone removal of hardware and revision open reduction internal fixation of the right ulna. Postoperatively, the patient was noted to be stable, and the postoperative course was as expected. The pain control was noted to be adequate, and the compartments were soft and compressible. There was minimal pain with wrist and digit flexion and extension. The postoperative pain management involved IV morphine. The IV morphine was given as the oral oxycodone caused nausea and an episode of emesis. The orthopedic progress notes state that there were no acute clinical events, and the pain had improved. The vital signs were stable. The patient was discharged to a skilled nursing facility. At issue is the medical necessity of an inpatient stay.
The inpatient stay was not medically necessary.
The provided documentation indicates that the patient presented to the emergency department with an ulnar plate failure and ultimately underwent hardware removal and a revision open reduction internal fixation of the right ulna. The postoperative course was uneventful, and the pain was noted to be well-controlled. While the treatment course included IV morphine for pain management, the document states that this was prescribed, as oral oxycodone caused nausea and an episode of emesis. There was no suggestion of severe comorbidities to necessitate an extended inpatient stay. There were no clinical circumstances that would support the inpatient stay versus treatment at a lower level of care in this case. The article cited below from the Journal of Bone and Joint Surgery states that the outpatient fracture pathway vastly improved the efficiency and timeliness of care.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Neck pain.
Treatment: Inpatient stay.

The insurer denied the inpatient stay. The health plan's determination is upheld.

The patient is a female with a prior surgical history of an ACDF (anterior cervical discectomy and fusion) C (cervical) 3 to C5. According to the indications section in the operative note, she initially did well, then over the past 2 years began to have increasing neck pain and left arm symptoms. A magnetic resonance imaging (MRI) reportedly showed spondylosis at C5-6 and C6-7. She underwent re-operation on her anterior cervical spine for removal of the prior C3 to C5 plate, ACDF C5-6 and C6-7 and replacement of a longer C3 to C7 plate. Postoperatively, she was admitted as an inpatient. 

The inpatient emergency admission was not medically necessary for this patient. It is very common to admit ACDF patients to a lower level of care in order to monitor them overnight, as the complications of respiratory distress from either tissue swelling or a postoperative hematoma usually occur the night of surgery and frequently require emergent attention. As the surgeon pointed out in his appeal letter, that risk is particularly pertinent in this patient who had undergone prior anterior cervical surgery, and he had recommended on overnight stay for that reason. However, that overnight observation recommended by the surgeon could have been carried out under a lower level of care. Then, if any postoperative complications had occurred, the patient could have been reclassified as an inpatient as needed.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Dental Disorder
Treatment: Braces
The insurer denied the Braces.
The determination is overturned.

The patient presented with a skeletal Class I malocclusion and mild spacing. She has an anterior open bite. Tooth number (#10) is in anterior crossbite. She is treatment planned for 18-24 months of orthodontics to address the spacing and open bite. The treatment was denied due to a lack of medical necessity. At issue is whether the braces are medically necessary.

Patients with an anterior open bite are among the most difficult patients to treat. (1) One side effect of an anterior open bite is reduced maximum bite force with less muscle activity while chewing than patients without an open bite. (2)
Studies have shown that patients with severe malocclusions, including anterior open bite, have significantly lower masticatory and gastrointestinal digestive function than persons with a normal occlusion. (3) However, it has also been shown that after orthodontic treatment, there was no difference in masticatory function and gastric emptying between the treated group and the control group with normal occlusion. (3) Given the patient's malocclusion and the likelihood of significantly reduced masticatory function and digestive function, orthodontic treatment is medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Skin Disorders. 
Treatment: Pharmacy/Prescription Drugs. 
The insurer denied Ilumya 100 milligrams per milliliter (MG/ML). 
The denial is upheld. 

The patient is a male with psoriasis. He has tried and failed betamethasone for one year. He has been on Ilumya with great improvement; his body surface area affected is currently 0%. The subject under review is the medical necessity of the Ilumya 100 milligrams per milliliter (MG/ML).

The health plan's determination is upheld in whole.

The requested health treatment of Ilumya 100MG/ML is not medically necessary for this patient. There is no documentation that the patient has tried and failed, has an intolerance to, or contraindication to the preferred therapies, making Ilumya medically necessary.
There is no medical and scientific literature and/or evidence based clinical practice guidelines that strongly support the administration of Ilumya for this patient's condition as an accepted standard of practice in the U.S.
There are no comparative, controlled studies showing that Ilumya has a superior efficacy to the health plan's preferred alternatives, such as phototherapy and methotrexate.
Within the peer-reviewed literature, Racz et al. writes "Phototherapy is a standard treatment option for psoriasis, generally applied if topical treatment modalities fail or are contraindicated...Phototherapy may lead to the clearance of psoriasis in 5 to 8 weeks" (2). Mehta et al. writes "Ultraviolet (UV) B phototherapy is most appropriate for patients with greater than (>)10 % affected body surface area who have not responded to topical treatments...narrow band ultraviolet B (NB-UVB) ...effective treatment options for psoriasis...Long-term data on NB-UVB indicate that it has a good safety profile" (3).
Additionally, West et al. 2016 conducted a review of eleven comparative, controlled studies that passed a Cochrane risk of bias analysis. They concluded that methotrexate achieved significant improvement in reducing psoriasis plaques. Methotrexate is a preferred treatment, and based on data analysis, 45.2% [95% confidence interval 34.160.0] of patients achieve psoriasis area and severity index (PASI) 75 at primary endpoint, Thus, methotrexate is an effective first-line treatment for the management of psoriasis (4).
Per the medical and scientific literature and/or evidence based clinical practice guidelines, and the documentation provided, the request for Ilumya is not necessary. The patient has not tried and/or failed a preferred agent. The patient also has no true contraindications listed to a preferred treatment modality that would make the use of Ilumya medically more appropriate than the other options. Therefore, the administration of Ilumya is not strongly supported for this patient and is not medically necessary.