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

Diagnosis:  Dislodged #15 crown
Treatment:  Crown lengthening on tooth #15
The Crown lengthening tooth #15 performed was not medically necessary.

Code D4249 is for a crown lengthening procedure which removes "hard" tissue from around the tooth to expose more tooth to grab onto with a crown.  The "hard tissue" is bone.  After the bone is removed, the gums are repositioned higher up on the neck of the tooth, thereby exposing more good tooth to use for a crown.  In this case, only the gum really needs to be trimmed, not the bone around the tooth.  The procedure to remove just gum tissue is called a gingivectomy.  This does not involve removing bone.  Since no bone is needed to expose more tooth structure in this case, code D4249 is not an appropriate procedure for this patient.  There is no need for a "hard tissue" crown lengthening procedure.  It is not medically necessary.
Appeal type: Experimental/Investigational
Decision: Upheld

Cardiac/circulatory problems;Cardiac Heart Problem
Surgical services

The patient has  recurrent symptomatic atrial fibrillation (AF), hypertension, hyperlipidemia, and sleep apnea who underwent cryoablation for  AF. Since then the patient has been to the emergency department (ED) with 2 episodes of AF.  CHADS-VASC score was 3 and  HAS-BLED score were reported to be 4. The patient has been started on amiodarone for  AF. The health plan's determination is upheld. No, the proposed health service or treatment Perq Transcatheter Closure of the left Atrial Appendage with Endocardil Implant, Including Fluoroscopy and 1 Inpatient day is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. This patient recently had an ablation for AF. Recurrences of AF in the first 2-3 months after ablation are common (up to 40%) and patients will often improve after this time. The patient is said to be at high risk of falls, but no falls were documented in the records. In addition, the patient was said to have a labile international normalized ratio (INR), but this was also not documented. HAS-BLED score  2. The 2019 focused update of the 2014 American Heart Association/American College of Cardiology/Heart Rhythm Society guideline for the management of patients with atrial fibrillation states that percutaneous left atrial appendage (LAA) occlusion may be considered in patients with AF at increased risk of stroke who have contraindications to long-term anticoagulation.
Appeal type: Experimental/Investigational
Decision: Upheld

Cardiac/circulatory problems;Cardiac Heart Problem
Surgical services

The patient has hypertension, hyperlipidemia, gastritis, obstructive sleep apnea, and atrial fibrillation (AF). The CHAD-VASC score was 3. The bleeding score, HAS-BLED, was 4. The patient is on coumadin. The echocardiogram showed normal systolic function without valvular disease. The patient underwent a cryoablation for atrial fibrillation (AF). The patient is felt to be at high risk for falls which while on an anticoagulant would result in major bleeding including intra-cranial bleeding. The provider would like to implant a left atrial appendage occlusion (LAAO) device so as to be able to stop the anticoagulant after 3 months. The health plan's determination is overturned. As noted above, Watchman is an excellent alternative to anticoagulation to prevent stroke in patients at high risk for bleeding as in this case. As such, it is reasonable and medically appropriate. Yes, the proposed health service or treatment Perq Transcatheter Closure of the left Atrial Appendage with Endocardil Implant, Including Fluoroscopy and 1 Inpatient day likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. The provider believes this patient is at high risk for bleeding. Left atrial appendage occlusion (LAAO) with the Watchman has been shown to be comparable to anticoagulation to prevent stroke with a lower risk of bleeding. As such the net effect of Watchman, i.e. efficacy plus safety, is superior to anticoagulation in at risk patients with AF and bleeding.
Appeal type: Experimental/Investigational
Decision: Upheld

Cardiac/circulatory problems;Cardiac Heart Problem
Surgical services

The patient has obstructive sleep apnea (OSA) (noncompliant with continuous positive airway pressure (CPAP)), hypertension (HTN), hyperlipidemia (HLD) and paroxysmal atrial fibrillation diagnosed. Patient was cardioverted. Patient then underwent catheter ablation for atrial fibrillation. Cryoablation of the pulmonary veins was performed. A preprocedural transesophageal echocardiogram (TEE) showed no left atrial thrombus. Multaq was to be stopped and warfarin was continued. It is recommended that the health plan's determination be upheld. The Watchman device is not likely to be more beneficial than standard anticoagulation for this patient. The study by Holmes, et al, (3) showed non inferiority of the device versus warfarin. While the study by Reddy et al. (4) showed superiority of the device versus warfarin, factors affecting these results included: over 30% of the patients had CHADS-VASC score of 1, (lower stroke risk), the study excluded those with atherosclerotic aortic plaques and symptomatic carotid atherosclerotic disease. The device is Food and Drug Administration (FDA) approved for patients indicated for anticoagulation with nonvalvular atrial fibrillation to reduce stroke risk, it is indicated for those patients with "an appropriate rationale to seek a non-pharmacologic alternative to warfarin". In this case, there is no indication that the patient is not suitable for warfarin or novel oral anticoagulants (NOAC). There is inadequate data supporting the Watchman as superior to anticoagulation for this patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Status post motor vehicle accident
Issue under review:  Arthroscopy

Determination:  The Arthroscopy was not medically necessary.

The patient is an adult female.  She was involved in a MVA (motor vehicle accident).  She reported injuries to both knees.  She had previously undergone arthroscopic surgery to her left knee over ten years ago and right knee two and a half years prior to the left knee surgery.  Her physical examination was significant for obesity, antalgic gait and tenderness.  She was found to have crepitus and full motion.  X-ray report was early degenerative disease.  Arthroscopic surgery was recommended for her right knee.  It was completed.

Surgical indications include confirming the pain generator and failure to improve with conservative management.  The medical record demonstrates several conditions that could be responsible for the patient's knee pain.  She has obesity, which can result in pains to knees secondary to excessive stress.  She has osteoarthritis that was greater than grade 3.  She was also found to have meniscal tears to medial and lateral compartments.  These findings were long standing. 

There was no report of conservative treatment, e.g., brace, injection, or therapy. 

The scientific literature does not recommend arthroscopic surgery for meniscal disease in the presence of arthritis. 

Based upon the above, there was no indication for the operation completed. 

AIM Clinical Guidelines state:

Meniscal repair or partial meniscectomy is considered not medically necessary when meniscal tear is associated with Kellgren-Lawrence grade >= 3 or modified Outerbridge grade > III osteoarthritis of the knee. (Exception may be granted for patients under age 40).
Appeal type: Medical necessity
Decision: Overturned

Respiratory System
Inpatient Hospital
This is a patient with a history of mild persistent asthma who presented with a worsening cough and increased work of breathing.
She was well until one day prior to admission when she developed a cough and increased work of breathing. She was given albuterol at home with some improvement. However, several hours later the cough worsened as did her respiratory distress. She was given additional albuterol with minimal improvement. She was also given prednisone, however, she vomited shortly after she took the medication. She was therefore brought to the emergency department for further care. Her past history is significant for 2 prior admissions for asthma.
In the emergency department, she was found to have labored breathing with retractions and tachypnea. On examination, she had diffuse expiratory wheezing with substernal retractions, grunting, and diminished breath sounds at the bases. Laboratory values were sent and she received 3 albuterol/Atrovent nebulizer treatments as well as albuterol, magnesium sulfate and Solu-Medrol. She vomited once in the emergency department. Upon reassessment after these treatments, she continued to have labored breathing and wheezing. She was therefore admitted to the intensive care unit for further management.
Upon admission she received continuous cardiopulmonary monitoring, methylprednisolone, and every 2 hour albuterol nebulized treatments. She also received half maintenance intravenous fluids. She required supplemental oxygen to maintain her saturation greater than 90%. She improved following this, and by the next day was able to wean to every 4 hour albuterol treatments.
The health plan's determination is overturned.
This is a very young child who presented in status asthmaticus. She had substantial wheezing and respiratory distress that persisted despite the initiation of treatment as an outpatient, and appropriate and aggressive treatment in the emergency department setting. She continued to have diffuse wheezes as well as retractions. She required hospital admission for very frequent administration of bronchodilator therapy as well as intravenous fluids and cardiorespiratory monitoring. She also required supplemental oxygen during the course of her hospitalization.
The decision-making at the time of admission for this patient was consistent with her young age, the presence of status asthmaticus that persisted despite appropriate therapies, and the need for ongoing intensive treatment including frequent bronchodilators (every 2 hours), intravenous fluids and supplemental oxygen with close monitoring for potential deterioration of clinical status.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Obesity
Issue under review: Qsymia

Determination:
The Qsymia is medically necessary.

The patient is an adult female diagnosed with Obesity. This request is for Qsymia. As reported recently, her BMI was 43.43; weight was 261 lb. She is on Contrave 2 tabs twice daily and it is not working well. She did not tolerate GLP-1 (glucagon-like peptide-1) Saxenda or Ozempic. She was on Victoza before that, but felt like it did nothing. She has PCOS (polycystic ovarian syndrome) and hypothyroid (on Synthroid). She has been on metformin 2000 mg (three to four years for PCOS). She was on lifestyle modifications with no weight loss.  She has pre-diabetes. 

Qsymia is indicated in the treatment of obesity [1-3]. The FDA label [4] is as follows:

--------------------INDICATIONS AND USAGE------------------------- 
Qsymia is a combination of phentermine, a sympathomimetic amine anorectic, and topiramate extended-release, an antiepileptic drug, indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:
1)	30 kg/m2 or greater (obese) (1) or 
2)	27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemia (1)
Limitations of Use:
1)	The effect of Qsymia on cardiovascular morbidity and mortality has not been established (1). 
2)	The safety and effectiveness of Qsymia in combination with other products intended for weight loss, including prescription and over the-counter drugs, and herbal preparations, have not been established (1).

The patient has a BMI greater than 30. The patient meets the FDA indication. The requested service has therefore been proven to be safe and effective in this patient's condition. Obesity is a disease. Treatment of obesity is not cosmetic. The request is consistent with generally accepted standards of medical practice and is therefore medically necessary.
Appeal type: Experimental/Investigational
Decision: Overturned

Pulmonary/cystic fibrosis
pharmacy/prescription drugs

The pediatric patient has cystic fibrosis (CF). The patient has multiple findings consistent with CF, including respiratory disease. Her mutations are: 3120+1G>A/T1036N. Orkambi was previously requested. Orkambi is indicated for those who are homozygous for delF508, which this patient is not.
Documentation which accompanies the appeal states that the requested medication is expected to help this member based on in-vitro experiments performed on the cells cultured from the nasal epithelial cells (NEC) of an older sibling, who has the same mutations.
Specifically, the sibling's NEC were grown as air-liquid interface cultures (ALI) and spheroid cultures and subjected to treatment with Kalideco, Orkambi, and Trikafta. Each treatment increased the function of the protein of interest (fibrosis transmembrane conductance regulator (CFTR), which is the defective protein in CF) in both ALI and spheroid cultures, with Trikafta showing the most significant effect. Since Trikafta is clinically approved for those older than 12 years years old, the next effective agent, Orkambi, has been requested. The health plan's determination is upheld in whole.
The requested drug is not FDA-approved for the mutations that this member has. While the in-vitro results are positive, there is no indication that they are directly translatable to in-vivo clinically significant results in patients with CF. The quoted literature [1][2] describes the establishment and validation of the screening models used to evaluate Orkambi, but the papers do not make (or support) the claim that their results are directly translatable to therapy in patients with CF. Moreover, as recently reviewed, [3]phenotypic screening is a renewed approach to lead discovery that may improve the success rate of drug approval by identifying new drug targets from phenotypic screening of known drug libraries. Once again, there is no claim of direct translatability to clinical therapy. There is no evidence that the proposed treatment (Orkambi) is likely to be more beneficial than the standard treatment for the member's condition (CF).
Appeal type: Experimental/Investigational
Decision: Overturned

Pulmonary/cystic fibrosis
pharmacy/prescription drugs

The pediatric patient  with Cystic Fibrosis. The fibrosis transmembrane conductance regulator (CFTR) mutation genotype is 3120+1G>A and either 3239C>A or T1036N (different mutations were noted in different documents). Medical issues include chronic lung disease, pancreatic insufficiency, and nasal polyps. The service under review is the medication Orkambi. This medication is only Food and Drug Administration (FDA) approved for the genotype F508del mutation. The submitted documentation includes data from a clinical trial in which the patient's sibling ( who has the same CFTR mutations) participated. In a cell model demonstrated modest improvement in CFTR function to Orkambi and significant response to Trikafta. The reviewer overturns in whole the health plan's determination regarding the proposed health service or treatment. There are more than 1,800 mutations of the cystic fibrosis gene; some are common, and others are rare and found only in a few people. The new class of medications, CFTR modulators, include molecules that act as correctors and/or potentiators. Understandably, the drug manufacturers study these new medications in patients with the most common CFTR mutations, such as F508del, which is present in about 70% of patients with cystic fibrosis. Unfortunately, patients with rare CFTR mutations (such as the member in question) are often left out of these clinical trials and thus wind up being excluded from being able to get access to such revolutionary medications. These two published studies demonstrated a good in-vitro response to the use of the drug in question. This provides relatively firm data that the member will likely respond to Orkambi. Lumacaftor/ivacaftor (Orkambi) is a fixed-dose tablet containing a corrector (lumacaftor) and potentiator (ivacaftor) of the cystic fibrosis transmembrane conductance regulator (CFTR) and thus treats the underlying cause of cystic fibrosis. It has been demonstrated to cause significant improvement in lung function, reduce pulmonary exacerbations, and improve body mass index (BMI), while having an acceptable tolerability profile.
Thus, given all of the above information, the proposed treatment with orkambi is likely to be more beneficial than any standard treatment for the insured's life threatening and disabling disease.
Appeal type: Experimental/Investigational
Decision: Overturned

Pulmonary/cystic fibrosis
pharmacy/prescription drugs

This  is a pediatric patient with 2 cystic fibrosis transmembrane conductance regulator (CFTR) mutation (Non delta 508), followed in a cystic fibrosis (CF) center, the physician is recommending Orikambi because Trikafta is approved only in patient's > 12 yrs. of age. The health plan's determination is overturned in whole. Orkambi is likely to be more beneficial than any standard treatments for the patient's condition.
Patient is having a body mass index (BMI) of 17 to 18, which is detrimental to  health and life. As well known, a healthy BMI is linearly correlated with survival in CF patients. Also, this patient has numerous other issues such as pseudomonas, candida colonization, nasal polyps, snoring, and a low forced expiratory volume in one second (FEV1) in spite of multiple treatment. The patient had cell based Cystic fibrosis transmembrane conductance regulator (CFTR) modulator analysis in the lab and was found that Trikafta will be the best treatment for the specific mutations, however Trikafta is only safe in 12 yrs. of age and above. The second best option that was determined in the lab was Orikambi and was found to improve lung function > 10 %. Hence, Orikambi is indicated and can be lifesaving. As it is well known, forced expiratory volume (FEV) and lung function directly correlates with survival in CF patients.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Decayed tooth 
 
Treatment: Cleaning inside roots of tooth (root canal) for tooth #14

The insurer denied coverage for cleaning inside roots of tooth (root canal) for tooth #14. The denial is upheld. 

This patient is a female who presented to the dental provider for treatment of tooth number 14. The dentist attempted to remove the decay in order to place a conventional restoration; however it was found that the decay had progressed to the level of the nerve chamber in the tooth. As the patient had been in some discomfort prior to beginning the filling procedure, it was decided that a pulpotomy would be performed to try to eliminate the discomfort, with the treatment plan being a root canal for tooth number 14. The patient returned two more times after which the root canal procedure had been completed for tooth number 14. She did not return following last visit where a temporary filling had been placed.

Heng C. (2016), "Further, if the tooth is too compromised with extensive destruction from the decay or if there are financial or other barriers to root canal therapy, extraction is likely the only option." A tooth that has been adversely affected by deep decay may be treated in one of two fashions.  The tooth may either be removed, which would eliminate the offending nerve and source of pain, or if structurally sound may be treated endodontically with root canal treatment. While it is beneficial to retain a tooth in the mouth when possible, removal is an acceptable alternative.

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

Based on the above, the medical necessity for the cleaning inside roots of tooth (root canal) for tooth #14 is not substantiated.  The insurer's denial is upheld.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Preeclampsia
 
Treatment: Inpatient Admission

The insurer denied the Inpatient Admission. The denial was reversed.   

This is a female patient more than 30 weeks gestation who presented to the hospital with complaints of hypertension. Her blood pressure on arrival was 154/81 with a repeat blood press of 197/119 an hour later. The fetal heart was monitored and was reassuring. She received intravenous (IV) fluids, IV Hydralazine, and IV betamethasone. Procardia and Labetalol were orally administered for treatment of her blood pressure. The patient signed out against medical advice (AMA).  

The patient presented with elevated blood pressure, no vaginal bleeding, no uterine contractions and no ruptured membranes.  There was no evidence of fetal compromise. 
Preeclampsia refers to the new onset of hypertension and proteinuria or hypertension and significant end-organ dysfunction with or without proteinuria after 20 weeks of gestation in a previously normotensive woman.  So based on this patient's presentation, her very elevated blood pressure and elevated urine protein, she had preeclampsia and admission for close monitoring, blood pressure control and prevention of adverse sequelae was medically necessary. 

According to MCG, Indications for admission include:

1)	Severe preeclampsia or eclampsia 
2)	Onset of seizures
3)	Fetal compromise 
4)	Hemodynamic instability
5)	Hypertension and acute end organ damage.

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

Based on the above, the medical necessity for the inpatient hospital services is substantiated.  The insurer's denial is reversed.