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

Diagnosis: Secondary hyperparathyroidism of renal origin.
Treatment: Rayaldee 300 milligram (mg) capsule.
The insurer denied Rayaldee 300 mg capsule.  
The determination is overturned.

The patient has a history of stage 4 chronic kidney disease (CKD) due to hypertension (HTN) and diabetes mellitus (DM). Her CKD is complicated by secondary hyperparathyroidism and a low vitamin D level. She reportedly has tried nutritional vitamin D supplements, calcitriol and sectoral without success. Her lab results show a creatinine of 2.05 with an estimated glomerular filtration rate (eGFR) of 28, a calcium of 9.0, an intact parathyroid hormone (PTH) of 126, and a vitamin D 25 of 17.9. Her provider has prescribed Rayaldee (an extended release calcifediol capsule). At issue is the medical necessity of the Rayldee.

The current Kidney Disease Improving Global Outcomes (KDIGO) 2017 Update Work Group to conclude that the risk- benefit ratio of treating moderate PTH elevations with calcitriol of vitamin D analogs (paricalitol/doxercalciferol) was no longer favorable and should be reserved only for severe and progressive secondary hyperparathyroidism. Accordingly, the present guidelines no longer recommends routine use of calcitriol or its analogs in CKD G3a to G5. Rayaldee is a treatment for secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and low vitamin D levels (25-hydroxyvitamin D less than 30 nanograms per milliliter (ng/mL)). It has demonstrated in randomized control trials that it can safely lower intact PTH levels and increase Vitamin D 25 levels and is therefore a better treatment option than calcitriol or vitamin D analogs.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Breast Cancer.
Treatment: Bioimpedance Spectroscopy.
The insurer denied Bioimpedance Spectroscopy. 
The health plan's determination is overturned. 

The patient is a female who was diagnosed with right breast invasive ductal carcinoma, LCIS (Lobular carcinoma in situ), and ALH (Atypical lobular hyperplasia). She subsequently underwent a right nipple-sparing mastectomy and right sentinel lymph node biopsy with 3 sentinel nodes removed. She later underwent placement of tissue expander for breast reconstruction.

Bioimpedance Spectroscopy (BIS) is likely to be more beneficial than any standard treatment or treatment for the insured's life-threatening or disabling condition or disease. BIS assessment has been shown in multiple recent studies to be more effective than standard methods such as circumferential monitoring. Early detection of lymphedema can improve patient outcomes and prevent the development of clinically significant lymphedema.
As a consequence of the removal of 3 sentinel lymph nodes, the patient is at risk of lymphedema. Studies show that early detection of lymphedema can lead to improved outcomes for the patient and also cost savings as more complex treatments can be avoided with early intervention.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Breast Cancer.
Treatment: Bioimpedance Spectroscopy.
The insurer denied Bioimpedance Spectroscopy. 
The health plan's determination is upheld. 

The patient is currently a woman who has been diagnosed with hormone receptor-positive invasive ductal carcinoma of the right breast. She underwent bilateral nipple delay procedures followed by bilateral total mastectomies with right axillary sentinel lymph node biopsy. The final pathology showed no residual carcinoma in the right breast, and three right axillary sentinel lymph nodes were without evidence of metastatic involvement. As part of her follow-up, Bioimpedance Spectroscopy (BIS) was ordered to assess her for subclinical lymphedema. 

Bioimpedance Spectroscopy is not likely to be more beneficial than any standard treatment or treatments for the insured's life-threatening or disabling condition or disease. In this particular case, the patient underwent a bilateral total mastectomy and right axillary sentinel lymph node biopsy with the removal of three benign sentinel lymph nodes. She does not have risk factors for the development of treatment-related lymphedemas such as full axillary lymph node dissection, removal of 6 or more lymph nodes, comprehensive nodal radiation, or obesity (she has a normal body mass index (BMI) of 22.05). Therefore, the patient's risk of developing lymphedema is quite low. The studies evaluating the efficacy of BIS for the detection of subclinical lymphedema were performed on patients at high risk for lymphedema, specifically, those who had comprehensive nodal radiation, complete lymphadenectomy, or sentinel lymph node biopsy wherein six or more lymph nodes were removed. These studies have not evaluated the efficacy of BIS in the setting of patients who underwent sentinel lymph node biopsy alone with fewer than 6 lymph nodes removed.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Breast Cancer.
Treatment: Bioimpedance Spectroscopy.
The insurer denied Bioimpedance Spectroscopy. 
The health plan's determination is overturned. 

The patient is a female with right breast cancer status post bilateral nipple sparing mastectomy with right sentinel node biopsy.
Under review is the use of Bioimpedance Spectroscopy. 

Bioimpedance spectroscopy is likely to be more beneficial than traditional methods of measuring or identifying lymphedema. Traditional methods of measuring or identifying lymphedema such as arm circumference are outdated and tend to identify lymphedema at later stages whereas Bioimpedance Spectroscopy allows for the identification of the very start of lymphedema even before significant physical signs may develop.
The key to managing lymphedema is to start treatment early to stabilize and decrease the severe morbidity of lymphedema.
Koelmeyer et al found that women who were in the early surveillance group and were able to have lymphedema care significantly earlier than those in the traditional referral group with the aid of bioimpedance studies had lower rates of stage and severity of lymphedema. Significantly more women in the traditional referral group were diagnosed with clinical lymphedema and with greater severity compared with those in the early surveillance group.
Clinicians involved in multidisciplinary centers routinely monitor and utilize Bioimpedance studies to help initiate early treatment for lymphedema in women who are at high risk for the development of lymphedema.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Obesity.
Treatment: EGD (esophagogastroduodenoscopy).
The insurer denied the EGD (esophagogastroduodenoscopy).
The denial is overturned

The patient is a female status post gastric sleeve, with ongoing obesity, going for gastric bypass. Her provider is requesting pre-operative EGD (esophagogastroduodenoscopy).

Yes, the requested esophagogastroduodenoscopy is medically necessary.

No, the health plan did not act reasonably, with sound medical judgment, and in the best interest of the patient.
The patient is status post gastric sleeve and was going for gastric bypass. She had no upper GI (gastrointestinal) complaints of abdominal pain, NV (nausea/vomiting), GERD (gastroesophageal reflux disease), or dysphagia.

Regarding preoperative EGD (esophagogastroduodenoscopy) in patients qualified for bariatric surgeries, Sierzantowicz et al. analyzed the prevalence of endoscopic pathologies in various gastrointestinal tract segments. Patients with obesity were shown to present with esophageal pathologies significantly more often than persons in the control group. The odds ratio of esophageal pathologies in patients with obesity versus the control group equaled 2.15 (95%CI [confidence interval]). In turn, the odds ratio of duodenal pathologies in patients from the control group was 3.31 (95%Cl [confidence interval]), which means that persons from this group were approximately three times more likely to be diagnosed with those pathologies compared to obese patients. Moreover, patient sex was a significant predictor of duodenal pathologies, with an odds ratio of 4.03 (95%CI [confidence interval]). They concluded that preoperative EGD (esophagogastroduodenoscopy) can identify a broad spectrum of pathologies in obese patients, which suggests a routine examination before bariatric surgery. Therefore, the requested pre-operative EGD (esophagogastroduodenoscopy) is clinically appropriate and accepted standard of medical care, and medically necessary. The health plan did not act reasonably with sound medical judgment and in the best interest of the patient by denying it.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Pancreatitis

Treatment: Inpatient hospital admission 	

The insurer denied coverage for an inpatient hospital admission. 
 
The denial is overturned.

The patient had a history of pancreatitis and presented with upper abdominal pain and vomiting. He was afebrile and the vital signs were stable. Upper abdominal tenderness was present, but there was no rebound or guarding. He was diagnosed with pancreatitis. It was felt that this could be medication related and enalapril and chlorthalidone were held. The lipase was 842 (normal to 78). An ultrasound revealed a normal pancreas. 

Clinical indications for admission for Pancreatitis [MCG (Milliman Care Guidelines) M-250] include having acute pancreatitis as manifested by 2 of the following indications. These include abdominal pain, serum lipase greater than 3 times the upper limit of normal, and imaging studies indicative of acute pancreatitis. In this case, the patient had upper abdominal pain and a lipase level that was much greater than 3 times the upper limit of normal.

This patient had acute pancreatitis of unknown etiology. It was felt to possibly be medication induced. He met the MCG criteria for a hospital admission. Therefore, the health care plan did not act reasonably or with sound medical judgment. An inpatient hospital admission was medically necessary. The denial is overturned.

The insurer's denial of coverage for the inpatient hospital admission is overturned. Medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Spastic quadriplegia secondary to cerebral palsy, contractures of lower extremities
Treatment: Inpatient hospital admission
The insurer denied the inpatient hospital admission.
The denial is overturned.

This is a male patient with spastic quadriplegia secondary to cerebral palsy (CP). He has associated medical conditions. He was found to have contractures to both lower extremities. The patient underwent bilateral adductor releases and hamstring lengthening. Bilateral long leg casts were applied with bar. His post surgical course was non-complicated. He was discharged the next day.

Yes, the proposed treatment was medically necessary.

The records show this patient had a complex and unique condition. There were several comorbidities as well. 

The physician performed four surgical procedures and applied bilateral casts. It would be important to monitor the postoperative status. The patient would not likely be able to verbalize pain levels. There would be need to evaluate neurological status as extremities have been extended and abducted after surgical release. There could be traction to neutral elements causing possible nerve damage. There were associated underlying medical problems to be monitored (i.e. [that is] use of feeding tube.) 

These services could not have been provided at a lower level of care.

No, the health plan did not act reasonably, with sound medical judgment, or in the best interest of the patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Central Nervous System/Neuromuscular Disorder. 
Treatment: Pharmacy/Prescription Drugs. 
The insurer denied Emgality. 
The denial is upheld.

The patient is a female with chronic migraine. Treatment with Emgality is the subject of this review. Emgality was denied because the patient has not tried and failed two oral preventative therapies. The patient has tried and failed topiramate due to nausea. The provider appealed the determination.

Treatment with Emgality is not medically necessary for this patient. The service was denied because the patient has not used a secondary preventative agent. The plan offers several preventative agents including beta-blockers, amitriptyline, venlafaxine, and Divalproex. All of these drugs are safe and effective in the prevention of migraine. The patient has failed an anticonvulsant, topiramate, and other drug classes including beta-blockers and antidepressants available. There is no medical reason why the patient cannot use one of these drugs rather than Emgality. Emgality has not been shown to be more effective than these medications for migraine prevention. 

The health plan's determination is upheld.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Breast Cancer
Treatment: Bioimpedance Spectroscopy
The insurer denied Bioimpedance Spectroscopy
The determination is overturned.

The patient has left breast cancer status post left lumpectomy with attempted sentinel node followed by a repeat superficial left axillary dissection. At issue is whether bioimpedance spectroscopy is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

Bioimpedance spectroscopy is more beneficial than traditional methods of measuring or identifying lymphedema. Traditional methods of measuring or identifying lymphedema such as arm circumference are outdated and tend to identify lymphedema at later stages whereas bioimpedance spectroscopy allows for the identification of the very start of lymphedema even before significant physical signs may develop.
The key to managing lymphedema is to start treatment early in an effort to stabilize and decrease the severe morbidity of lymphedema.
Koelmeyer et al found that women who were in the early surveillance group and were able to have lymphedema care significantly earlier than those in the traditional referral group with the aid of bioimpedence studies had lower rates of stage and severity of lymphedema. Significantly more women in the traditional referral group were diagnosed with clinical lymphedema (stage I-III, 39 % versus (vs) 14%; probability [P] less than [<] .001) and with greater severity (stage II-III, 24%) compared with those in the early surveillance group (4%).
Clinicians involved in multidisciplinary centers routinely monitor and utilize bioimpendance studies to help initiate early treatment for lymphedema in women who are at high risk for the development for lymphedema. This particular patient is young has had her left axilla surgically examined and altered twice due to surgery increasing he risk for the development of lymphedema.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Breast Cancer
Treatment: Bioimpedance Spectroscopy
The insurer denied Bioimpedance Spectroscopy
The determination is overturned.

The patient presented with left breast invasive ductal carcinoma estrogen receptor (ER)/ progesterone receptor (PR) positive and human epidermal growth factor receptor 2 (Her2/neu) negative. She underwent a left lumpectomy and left axillary node dissection. At the time of surgery, her sentinel node did not map and an axillary node dissection was indicated. Due to her undergoing an axillary node dissection and requiring post operative radiation she is at higher risk of developing lymphedema. For this reason, monitoring for lymphedema with bioimpedance spectroscopy (BIS) was requested and is under review.

Yes, bioimpedance spectroscopy is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
BIS assessment has been shown in multiple recent studies to be more effective than standard methods such as circumferential monitoring. Early detection of lymphedema can improve patient outcomes and prevent the development of clinically significant lymphedema.
Due to this patient undergoing an axillary node dissection and requiring postoperative radiation, she is at higher risk of developing lymphedema. For this reason, monitoring for lymphedema with bioimpedance spectroscopy is indicated. BIS is currently approved by Medicare and has the ability to detect lymphedema early and institute early intervention. This also leads to significant improvement in quality of life for the patient.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Digestive System/Gastrointestinal-Abdominal pain.
Treatment: Inpatient Hospital.
The insurer denied Inpatient Admission. 
The denial is overturned. 

This patient is a male with a past medical history significant for untreated Crohn's disease with perianal disease, history of human immunodeficiency virus (HIV) on antiretroviral therapy (ART), and substance abuse, who presented with abdominal pain and bloody diarrhea. On admission, labs revealed anemia, thrombocytosis suggestive of acute inflammation, and electrolyte derangements in the setting of a computed tomography (CT) scan of left-sided colitis. He was admitted to the inpatient floor and started on intravenous (IV) fluids with electrolyte replacement, given IV antibiotics, an infectious work-up, general surgery, and gastrointestinal (GI) consultation. The patient left against medical advice.
At issue is the medical necessity of the Inpatient Admission.

The health plan's determination of medical necessity is overturned in whole.

Yes, the requested health service/treatment of Inpatient Admission is medically necessary for this patient.

This is a male with comorbidities (untreated Crohn's disease, immunosuppression secondary to HIV on ART, polysubstance abuse, history of bipolar illness) admitted for abdominal pain and hematochezia in the setting of colitis. His clinical presentation was worrisome for many competing acute medical issues, including infectious diarrhea in the setting of immunosuppression, Crohn's disease flareup, and active gastrointestinal (GI) bleeding. He required urgent inpatient care for prompt diagnostic work-up of hematochezia, correction of his electrolyte derangements, serial monitoring of labs for anemia, infection, and electrolytes, and management of his Crohn's disease, including GI and surgical consultation. Delay in the prompt medical management of his presentation could result in peritonitis, bleeding, shock, and death. This detailed inpatient care cannot be prudently provided on any other level of care in this patient with significant comorbidities. This is a high-risk patient with significant comorbidities who needed prompt and thorough diagnostic workup and management.

Therefore, the requested health service/treatment of Inpatient Admission is medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Abdominal pain, nausea, vomiting. 
Treatment: Inpatient admission. 

The insurer denied the inpatient admission. 
The denial is overturned. 

The patient is a female. She presented to the ER (emergency room) with complaints of abdominal pain, nausea, and vomiting. 

The patient had WBC (white blood count) of over 20 and elevated lactate. The patient was febrile to 102 F (Fahrenheit) and tachycardic. The patient underwent laparoscopic appendectomy. She was admitted for two days and discharged to home after she was tolerating diet and her pain was well-controlled. 

Yes, the Inpatient admission was medically necessary. 

The patient was by definition septic on admission, with a fever of 102, tachycardia, elevated WBC (white blood count), and elevated lactate. The patient's source was her appendix, which had evidence of abscess formation. This is evidence of micro-perforation of the appendix. The patient's admission was clinically appropriate due to her admission diagnosis of sepsis due to appendicitis. She was kept for two days, and she responded well to antibiotics and tolerated her diet. 

No, the health plan did not act reasonably, with sound medical judgment, and in the best interest of the patient. 

This patient met criteria for admission with her presence of an active infection and sepsis on presentation. This patient required inpatient admission for her appendicitis.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Paroxysmal atrial flutter.
Treatment for Eliquis (apixaban).
The insurer denied coverage for Eliquis (apixaban).
The denial is overturned.

According to the documentation submitted, this is a female patient with a history of atrial flutter and CHADSVASC [congestive heart failure, hypertension, age >= 75 years, diabetes mellitus, stroke or transient ischemic attack (TIA), vascular disease, age 65 to 74 years, sex category] score of 3.
Relevant past medical history includes chronic kidney disease (stage 4) with a creatinine of 2.4 milligrams per deciliter (mg/dl) and creatinine clearance of 26 milliliters per minute (ml/min), unrepaired tetralogy of Fallot, diabetes mellitus and hypertension. The patient was treated with rivaroxaban therapy for prevention of stroke in the setting of paroxysmal atrial flutter. Following the development of worsening renal function, she was taken off rivaroxaban and treated with apixaban. 

The formulary drug is likely to cause the patient an adverse reaction. The 2019 American Heart Association, American College of Cardiology and Heart Rhythm Society Guidelines provide a Class I (level of evidence A) recommendation for treatment with novel oral anticoagulant regimen instead of warfarin. This recommendation was based on several randomized clinical trials that enrolled thousands of patients. The direct thrombin inhibitor medications and the Factor Xa inhibitor medications (including Xarelto/Rivaroxaban and Eliquis/Apixaban) were at least non inferior and in some cases superior to warfarin therapy. (Reference 1) The Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF trial) demonstrated that rivaroxaban was non inferior to warfarin therapy. However, patients with moderate renal failure did not seem to benefit from Xarelto therapy and had higher bleeding rates. (Reference 2) Moreover, The ROCKET AF trial excluded patients with creatinine clearance of 30 ml/min. Thus, this patient with a creatinine clearance of 26ml/min would not have been eligible for the trial. Renal elimination amongst direct oral anticoagulant agents is lowest with apixaban. (Reference 3) In a metanalysis of 14000 patients, treatment with apixaban appeared to be superior in combined safety and efficacy endpoints than rivaroxaban in patients with moderate chronic kidney disease. (Reference 4) A subgroup analysis of patients enrolled in the Aristotle trial, with creatinine clearance below 30ml/min, patients that received apixaban had significantly lower bleeding rates than those treated with warfarin. (Reference 5) In conclusion, the requested drug would be more effective than the formulary drug, due to the patient's history of chronic kidney disease and creatinine clearance of 26ml/min.  

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 Formulary Exception for Eliquis (apixaban) is overturned.