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

Diagnosis: Osteosarcoma. 
Treatment: Skin graft. 

The insurer denied coverage for Skin Graft Synthetic code 15271. 

The denial is upheld. 

This male patient has a medical history of newly diagnosed high grade osteosarcoma of the proximal left tibia with chondroblastic and osteoblastic features who underwent  radical resection of the left tibia and fibula, total knee replacement, repair and reconstruction of the patellar tendon with Dacron aortobifemoral graft, gastrocnemius muscle pedicle flap, split-thickness skin graft, application of negative-pressure dressing, application of long-leg splint, popliteal artery/vein exploration, exploration of anterior and posterior tibial vessels and internal fixation of tibia fracture with intramedullary rod and cerclage cable. The pre-operative diagnosis was malignant neoplasm of bone and articular cartilage, unspecified and osteogenic sarcoma of the left tibia with post-op diagnosis pending pathology. It was noted that the split-thickness graft was over a 16 x 5 cm defect and 0.012 of an inch in graft was use. The split-thickness graft was harvested from the arteriolateral thigh proximally. The patient tolerated the procedure with no noted complications with estimated blood loss 1500 milliliters. The patient was taken to recovery in good condition. 

The medical record demonstrated extensive reconstructive surgery. This included surgery to neurovascular, bone and soft tissue. The reconstruction included a gastrocnemius flap. The reconstruction included a large split thickness skin graft harvested from the thigh. The records do not show use of any synthetic material utilized. There was no documentation reporting insufficient coverage to require artificial skin material. These clinical findings support the denial (procedure was not completed nor required). 

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

Based on the above, the medical necessity for Skin Graft Synthetic code 15271 is not substantiated. The insurer's denial should be upheld.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Asthma.

Treatment: Inpatient hospital admission.

The insurer denied coverage for inpatient hospital admission.

The denial is overturned. 

This female adolescent patient has a history of severe persistent asthma and obesity. The patient has been admitted to the hospital on 10 previous occasions with 2 or 3 admissions to the Pediatric Intensive Care Unit (PICU) because of the severity of her illness. The patient has been on daily treatments with Dulera, Singulair and Spiriva, and monthly intramuscular injections of mepolizumab. 

On this occasion, the patient was sick for 1 week with coughing, dyspnea and chest pain.  On the day prior to the admission, the patient was seen in the Emergency Room (ER) and was treated for asthma with steroids, albuterol and magnesium. The patient was discharged from the ER after improving with treatment; however, that night the patient awoke with shortness of breath. The patient was treated with 20 milligram (mg) of prednisone and 2 nebulizer treatments of albuterol at home, but continued to have rapid breathing, shortness of breath and feeling of chest tightness. The patient went to the pulmonary clinic on the morning of the admission. In the pulmonary clinic, the patient was evaluated by the pulmonologist. The patient was noted to have wheezing and retractions so the patient was again referred to the ER for treatment of status asthmaticus and failure to respond to steroids administered the day prior in the ER.  When the patient's respiratory distress did not improve in the ER, the decision was made to admit the patient with a diagnosis of status asthmaticus for ongoing treatment with intravenous (IV) fluids and frequent albuterol treatments.

Based on the review of the medical record and literature, inpatient admission was medically necessary for this patient. This patient with severe persistent asthma presented to the Emergency Room (ER) with status asthmaticus that was not responsive to outpatient therapy and ER intervention. The patient was treated appropriately in the ER for coughing, wheezing and respiratory distress. When there was ongoing chest tightness with wheezing and increased work of breathing despite having been treated with steroids in the ER the day prior to the admission, the patient was appropriately admitted to the hospital for ongoing care for status asthmaticus. The decision to admit was clinically appropriate and consistent with the standard of care. The patient was not stable enough to be sent home in view of her past history of severe asthma which had resulted in multiple admissions to the hospital.

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

Based on the above, the medical necessity for the inpatient hospital admission is substantiated. The insurer's denial should be overturned.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Digestive System/Gastrointestinal. 
Treatment: Surgical Services. 

The insurer denied: Surgery for repair of anal fistula plug. 
Denial is upheld. 

The patient is a male who underwent anal fistula plug placement. Two fistula tracts were identified with the same internal opening. Two fistula plugs were sewn into the tracts. The mucosal defects were closed. The procedure was terminated. Postoperatively the patient initially did well and in postoperative day 8 he appeared to be healing well. At the two week visit he appeared to be healing well. One month later one cavity was completely closed and the other was much smaller. 4 months later on examination it appeared the fistula had recurred. The subject under review is whether the proposed surgery for repair of anal fistula plug is likely to be more beneficial than any standard treatment for this patient. 

The proposed health service or treatment "Surgery for Repair of Anal Fistula Plug" is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. 

The documentation does not suggest the amount of muscle involved in the fistula which limits evaluation of the usefulness of the plug over alternative options. If there was minimal muscle involvement, fistulotomy is 95% effective at treating the fistula. LIFT (ligation of intersphincteric fistula tract) and anal advancement flap are more effective than anal plug. Fistula plug has not been shown to be effective in treating fistula's. In general, it is reserved for use after other methods have failed or when it is the only option to prevent problems of incontinence. This has not been demonstrated in this case.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Digestive System/Gastrointestinal. 
Treatment: Surgical Services. 

The insurer denied: Surgery for repair of anal fistula plug. 
Denial is upheld. 

The patient is a male with a previous anal fistula with a cavity of granulation tissue, and a more current short track anal fistula. In the surgical procedure to attempt to resolve the fistula disease, 2 fistula plugs were placed. This review concerns whether the use of bioprosthetic anal fistula plugs would be considered more beneficial for this patient than any standard treatment for his condition. 

No, the anal fistula plug procedure is not likely to be more beneficial than standard treatments. The published evidence for the effectiveness of biosynthetic anal fistula plugs is weak and not considered superior to standard anal fistula surgery. The medical policy considers biosynthetic anal fistula plugs to be investigational. 

Representative is Tao's recent 2020 published paper which found case series results seemingly inferior to historical standard surgical series, and possibly worse anal function. The authors write, "A total of 123 patients who had an adequate follow-up in the end were included. The median duration of follow-up was 8 years (range 72-121 months). The overall healing rate was 56% (69/123), and 33 (26.8%) patients had decreased anal function after surgery". The authors conclude "As a sphincter-preserving technique for the treatment of anal fistulas, the anal fistula plug procedure might impair the anal function" (1). 

Long term results out to 70 months were evaluated in a 2019 study by Hansen that found 39% success and concluded, "The use of bioprosthetic plugs to treat patients with complex anal fistulae seems to be a safe, viable option for complex fistula repair when other surgical attempts have failed. However, it should not be the treatment of choice. Further prospective randomized studies with a sufficient sample-size and standardized measurements are necessary to evaluate the efficacy of fistula plugs fully" (2). 

The recent randomized controlled trial (RCT) "The Surgisis anal fistula plug is associated with similar fecal incontinence quality of life (FIQoL) score to surgeon's preference at 12-month follow-up. The higher costs and highly uncertain and small gains in quality adjusted life years (QALYs) associated with the fistula plug mean that this technology is unlikely to be considered a cost-effective use of resources in the United Kingdom (UK) National Health Service (NHS)." (3). 

Thus, there is little evidence within the standard of care published literature to reach a finding that the plug would be more beneficial than standard therapy or to find that it is not investigational. The plug remains a subject of ongoing studies but does not have widespread endorsement or acceptance as a treatment for anal fistula. There is little evidence that would support the use of these bioprosthetic anal fistula plug procedures as superior to standard surgical technique. As the authors in Hansen's review conclude, there may be a role when other procedures have failed but not as standard therapy.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Digestive System/Gastrointestinal. 
Treatment: Surgical Services. 

The insurer denied: Surgery for repair of anal fistula plug. 
Denial is overturned. 

The patient is a male who was diagnosed with a chronic, submuscular fistula-in-ano that is unrelated to inflammatory bowel disease (the patient's fistula is of cryptoglandular origin). The patient underwent an elective surgery that involved the insertion of two fistula plugs as definitive therapy for complex fistulous disease. Though a postoperative clinic encounter suggested that the healing of the surgical-site may have been delayed, the most recent postoperative clinic encounter describes no examination findings, or patient complaints, that would suggest a persistent or a recurrent fistula. The subject under review is whether the proposed surgery for repair of anal fistula plug is likely to be more beneficial than any standard treatment for this patient. 

The proposed treatment is likely to be more beneficial, and in fact, the use of a fistula plug is one of several standard or conventional treatments for anal fistulas, especially those that are submuscular and for whom a fistulotomy would be inappropriate due to a risk for fecal incontinence. Other definitive treatments for fistulas of this type would include a LIFT (ligation of intersphincteric fistula tract) procedure, or a sliding flap repair, but both of these procedures are more invasive and are more complex to perform compared to the insertion of a fistula plug.

The insertion of a fistula plug is not experimental, as described in the most recent American Society of Colon and Rectal Surgeons (ASCRS) clinical practice guidelines, which state, "Despite the variability in healing with a fistula plug, the real possibility of success coupled with its sphincter-preserving nature allows this therapy to remain an option that may be considered for the treatment of fistula-in-ano."
Appeal type: Medical necessity
Decision: Upheld

Cancer
Pharmacy/Prescription Drugs

Diagnosis: Cancer.
Treatment: Sutent.
The insurer denied Sutent. 
The health plan's determination is upheld. 

This is a male with of a recently resected gastrointestinal stromal cell tumor (GIST). The patient underwent a resection (R0). Adjuvant therapy has been recommended. The patient's tumor has a KIT exon 9 gain function mutation. Sunitinib (Sutent) has been recommended and is under review.

Sutent is not medically necessary for this patient.
Data demonstrating a benefit of sunitinib over imatinib, the existing standard of care, is sparse. The data sets that have been published are small and there is a paucity of randomized data demonstrating an outcome to the proposed approach. The authors of UpToDate state "...Because of these small numbers, the data cannot be considered definitive, but the therapeutic impact of adjuvant imatinib in these subsets certainly seems much smaller. As a result, whether patients with KIT exon 9 mutations, PDGFRA (Platelet Derived Growth Factor Receptor Alpha) exon 18 D842V mutations, or "wild-type" GISTs should be identified prospectively and specifically counselled not to receive standard-dose adjuvant imatinib is controversial....".
Both the authors of UpToDate and the National Comprehensive Cancer Network (NCCN) Guidelines continue to use imatinib in this clinical scenario. Lacking additional supporting literature, medical necessity cannot be established.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Cholelithiasis
Treatment: Inpatient Hospital Stay
The insurer denied the Inpatient Hospital Stay.
The determination is upheld.

The patient presented to the emergency department with 3 days of epigastric and right upper quadrant pain. The patient had a pulse of 110; her other vital signs were unremarkable. The examination demonstrated tenderness in the right upper quadrant (RUQ) without rebound or guarding. The patient had a normal white blood cell count. She had an elevated D-dimer. The patient underwent a computed tomography (CT) pulmonary embolism (PE) protocol which demonstrated concern for portal vein thrombosis. A RUQ ultrasound demonstrated a patent portal vein and cholelithiasis without evidence of cholecystitis. An electrocardiogram (EKG) demonstrated sinus tachycardia and a new right bundle branch block. Surgery was consulted and took the patient to the operating room for a laparoscopic cholecystectomy. The procedure was uncomplicated. The patient did well and was discharged home. Pathology demonstrated chronic cholecystitis with focal cholesterolosis and cholelithiasis. At issue is the medical necessity of an inpatient stay.

The inpatient stay was not medically necessary.
The patient did have a chronically inflamed gallbladder which was treated with a laparoscopic cholecystectomy. The patient did not demonstrate significant systemic illness, significant vomiting, dehydration, hemodynamic instability, severe pain, signs of intestinal obstruction or peritonitis, or bacteremia. The documentation does not suggest that the patient's care could not have been performed at a lower level care. There is no evidence that additional complex testing or therapy other than the surgery was performed. There is no evidence that a complicating event occurred before, during, or after the procedure that required a higher level of care. There is no documentation that the treating team identified conditions or problems specific to the patient that would have required inpatient care. The provided documentation does not support the medical necessity of inpatient level of care.
Appeal type: Medical necessity
Decision: Upheld

Orthopedic
Skilled Nursing Facility

Diagnosis: Femoral and patella fracture 
Treatment: Sub-acute rehabilitation 
The insurer denied sub-acute rehabilitation. 
The health plan's determination is upheld.

The patient is a female who suffered a traumatic femoral and patella fracture requiring open reduction internal fixation (ORIF) of right distal femur fx (fracture). Post-operatively, the patient was admitted to skilled nursing facility. The patient requested approval for continued rehabilitation stay.

The sub-acute rehabilitation is not medically necessary. The patient was admitted to skilled nursing facility for post-acute rehabilitation following hospital course related to acute traumatic femoral and patella fracture status/post (s/p) ORIF right distal femur. At time of initial evaluation, she required moderate assistance (MODA) for bed mobility, transfers and ambulation of 5' with wheeled walker (WW). She was non-weight bearing (NWB) to her right lower extremity (RLE). Documentation noted that she lived in a 3rd floor apartment with steps to manage. Review of documentation noted that she made excellent progress and she had good static standing, ambulated 275' with WW modified independent (MODI) and was able to ascend and descend 12 steps with contact guard assist (CGA).

Documentation also noted that she was modified independent with meal prep/clean up and bed making. She also required set-up for car transfers. This level is appropriate for discharge to a lower level of care. Additionally, while therapy discharge did note some additional progress this level of progress was not required to discharge to a lower level of care and could have been met with outside therapy services. For example, therapy stated patient ambulated 100' without an AD (assistive device) independently, but the patient was already ambulated 275' with a WW MODI. Steps did improve to supervision, but steps alone is not reason to keep a patient at this level of care. Lastly, the documentation did not support that the patient was not medically stable for last covered day. Despite reports of an eye infection, this is not a diagnosis nor treatment regimen that requires skilled nursing care. Additionally, it was documented that the patient reported new right hip/thigh pain and an x-ray was ordered yet there was no follow-up documentation regarding such pain, leading this reviewer to opine the patient was medically stable. Additionally, right hip pain alone does not support continued rehab stay, especially since the physical exam did not even include a musculoskeletal component.
Appeal type: Medical necessity
Decision: Upheld

Central Nervous System
Inpatient Hospital

Diagnosis: Rule out Seizure
Treatment: Inpatient stay
The insurer denied the inpatient stay. The health plan's determination is upheld. 

The patient is a male child born at term with neonatal history significant for congenital torticollis and Staphylococcus folliculitis who presented to the emergency department (ED) for evaluation of stiffening episodes over the prior two weeks, with four episodes a day over the prior three days. The initial episodes involved his head shaking up and down, but the most recent episodes also involved outward stiffening of his extremities. He had no fevers or respiratory distress and he was feeding well. There is family history of consanguinity in the parents and seizures in an aunt and niece. Vital signs included temperature 37, heart rate 128, respiratory rate 26, and 98% saturation in room air. On exam, he was playful, with non-focal neurologic exam. Because of concern for infantile spasms, a Neurology consultation was obtained. The baby had a cluster of four episodes while in the ED during the Neurology evaluation prompting referral for admission and video electroencephalogram (EEG) monitoring. 

The Inpatient hospital admission was not medically necessary for this patient.
Infantile spasm is an age-specific syndrome of early infancy associated with abnormal seizure-like movements. In addition to the spasms, patients may experience neurodevelopmental regression. There is an associated specific EEG finding called hypsarrhythmia. When all three components are present (spasms, regression, hypsarrhythmia), it is called West syndrome. About two-thirds of infants with infantile spasms have neurologic abnormality. More recent literature suggests a genetic underpinning with abnormalities in the development of GABAergic regions. First line treatment alternatives include adrenocorticotropic hormone (ACTH) and vigabatrin. West syndrome is particularly difficult to treat. Early identification is crucial in improving neurodevelopmental outcome.
This patient presented to the ED with abnormal movements increasing in frequency over the course of two weeks that were concerning for infantile spasms. He was otherwise healthy and thriving. A cluster of spells was witnessed in the ED during Neurology consultation prompting admission for video EEG monitoring. The movements were considered atypical for infantile spasms and the video EEG was unremarkable, with no evidence of hypsarrhythmia. However, because of the family history of seizures and consanguineous parents, he was referred for outpatient follow-up in the Pediatric Epilepsy Clinic. While it was reasonable and appropriate to monitor this patient in the hospital overnight, including video EEG, to determine the etiology of his abnormal movements, he was overall hemodynamically stable with no significant neurologic deficits, able to feed, with normal activity. He did not require acute inpatient admission and could have been safely evaluated and managed at a lower level of care.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Digestive System/Gastrointestinal-Abdominal pain
Treatment: Inpatient stay
The health plan denied the inpatient stay as not medically necessary. 
The denial is upheld in whole.

The patient has a history of hypertension, and hypothyroidism. The patient was admitted to the hospital for abdominal pain and rectal bleeding. The abdominal pain was for approximately 72 hours. The patient also has a longstanding diagnosis of irritable bowel syndrome(IBS) and stated that his abdominal cramping was more severe than baseline. On physical exam he appeared in no apparent distress (NAD). Abdomen was benign on exam. The complete blood count (CBC) resulted with a normal white blood cell count (WBC) and hemoglobin(Hgb). There were minor liver function test (LFT) abnormalities. A computed tomography (CT) scan from the emergency room (ER) was essentially unremarkable. The gastrointestinal (GI) physician wanted an admission for the possibility of ischemic colitis. The patient was given opioids for pain control. He was discharged without further issues the following day. 

The inpatient stay was not medically necessary. Based on the objective findings on physical exam, including a benign abdomen, laboratory results with a normal WBC and HGB, and CT scan findings which were essentially unremarkable, there was a very low likelihood for a serious underlying GI problem, including ischemic colitis. The patient could have been appropriately managed at a lower level of care. Inpatient stay was not medically necessary.