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


Diagnosis: mobility issues.
Treatment: Personal Care Assistance Service: 24 Hours per Day, 7 Days per Week (Split Shift) - Total of 168 Hours per Week.
The insurer denied Personal Care Assistance Service: 24 Hours per Day, 7 Days per Week (Split Shift) - Total of 168 Hours per Week. 
The health plan's determination is overturned. 

The patient is a female with past medical history of hypertension, hyperlipidemia, gastroesophageal reflux disease (GERD), anemia, chronic obstructive pulmonary disease (COPD), chronic oxygen use, diabetes mellitus type 2, dementia, anxiety, osteoarthritis, urinary incontinence, and bowel incontinence who had been assigned PCA (personal care assistant) services.

Personal Care Assistance Service: 24 Hours per Day, 7 Days per Week (Split Shift) - Total of 168 Hours per Week medically necessary for this patient.
There is documentation from the patient's medical provider of medical necessity of increased PCA services. The medical provider documents overnight care needs that would not allow a PCA 5 hours of uninterrupted sleep. Overnight care logs provided also document specific assistance with activities of daily living (ADL) in the overnight hours that would not allow a PCA 5 hours of uninterrupted sleep. Due to the patient's dementia, she may not be able to alert 911 if needed. The requested increase in PCA services is not solely for safety and supervision but to assist the patient with safe completion of ADLs and Instrumental activities of daily living (IADL). The patient's care needs cannot be met with adaptive equipment and medical supplies. The patient is on chronic oxygen but does not need assistance with changing the level of flow rate but assistance with transferring and walking without becoming entangled in her oxygen tubing. There was no documentation from medical records of the need to check blood sugars on a regular or frequent basis. The documentation provided does not state the patient is on an insulin regimen. Taking into account the clinical standards, all information provided regarding the patient, the attending physician's recommendations, and the applicable and generally accepted practice guidelines, PCA services 24 hours/day, 7 days/week, split-shift, to total 168 hours/week are medically necessary for this patient. Personal care services are medically necessary when assistance with nutritional and environmental support function is essential to the maintenance of the patient's health and safety in her own home.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Hepatitis B.

Treatment: Viread 300 milligram (mg).

The insurer denied coverage for Viread 300 milligram (mg).

The denial is upheld.

The patient has chronic Hepatitis B. She has tried twice in the past tenofovir disoproxil fumarate but was unable to tolerate it due to abdominal bloating and nausea. She has been able to tolerate Viread and it has been controlling her Hepatitis B. 

The American Association for The Study of Liver Disease (AASLD) has published a guideline on Chronic Hepatitis B. There are multiple approved antiviral therapies for chronic Hepatitis B. Among these are Lamivudine, Telbivudine, Entecavir, Adefovir, and Tenofovir. 

This patient has not tolerated generic tenofovir due to an inactive ingredient in the generic formulation. She has tolerated the brand name Viread which is not formulary. The insurance company has stated that she needs to try a different Hepatitis B treatment that is formulary prior to being approved for Viread. The AASLD has given multiple alternative medications for chronic hepatitis B that are on formulary. It is appropriate to try a different AASLD approved drug that is on the formulary. The other formulary drugs have not been tried so it is not known if there will be an adverse reaction. They have not been shown to be ineffective. Therefore, it is not known if the requested drug would be more effective than the other formulary drugs. Since there are several alternative formulary drugs that have not been tried and have been recommended by the AASLD, the denial is upheld

The carrier's denial of a request for a Formulary Exception for Viread 300 milligram (mg) tablet to treat hepatitis B is upheld.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Psoriasis
Treatment: Cosentyx (with additional supply limits 10 per 
month)
The insurer denied:  Cosentyx (with additional supply limits 10 per month)
The denial is Upheld.

The patient is an adult female with psoriasis, treated with topical steroids. The provider is requesting Cosentyx. The health plan requires use of formulary agents Humira, Stelara, Tremfya, Cimzia, Enbrel or Skyrizi. The patient is experiencing joint pain as well, and the provider wishes to use Cosentyx to treat both psoriasis and psoriatic arthritis.

The requested Cosentyx is not medically necessary.

The patient has not tried and failed preferred biologics and does not have a contraindication to these. These are also safe, effective and widely used therapies. Currently, there are no guidelines on first-line therapies for patients. Cosentyx has been compared to Stelara in trials, but not extensively to other agents.
The meta-analysis published in 2018 (Loos et al) concluded that the interleukin 17A inhibitors are more effective in achieving clearance than ustekinumab, and they are generally more effective than etanercept, adalimumab, and apremilast. However, this is not based on large randomized controlled trials.
The meta-analysis by Bai et al concluded that IL (interleukin)-17, IL (interleukin)-12/23, and IL (interleukin)-23 inhibitors had high efficacy in the achievement of PASI (Psoriasis Area and Severity Index) 75, PASI (Psoriasis Area and Severity Index) 100, and sPGA (Static Physicians Global Assessment) 0/1 or IGA (Investigator's Global Assessment) 0/1 or PGA (Physician Global Assessment) 0/1 in moderate to severe plaque psoriasis after 12 or 16 weeks of treatment. Stelara, Tremfya and Skyrizi are IL (interleukin)-12/23 and would also be appropriate for arthritis.
Therefore, as the preferred agents are also appropriate therapies and within standard of care, the requested Cosentyx is not medically necessary.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Migraine headaches

Treatment: Aimovig 140 milligrams per milliliter (mg/mL)

The insurer denied coverage for Aimovig 140 milligrams per milliliter (mg/mL)

The denial is overturned.

According to the medical records, the patient is an adult seen for follow up regarding headaches. It was noted that the patient's headaches have been well controlled over the prior 6 months. The patient continued to be on Aimovig for Migraine and the plan was to continue with the current regimen which included Aimovig and Zonisamide. There was a letter by the nurse practitioner to appeal the denial of coverage of Aimovig. She noted that the patient migraines have been well controlled on the Aimovig for several years.

It may be possible for formulary drugs to cause an adverse reaction. Side effects cannot be predicted. Changing therapy carries risk of treatment failure.

Goadsby, PJ. et al. (2017), "CONCLUSIONS Erenumab administered subcutaneously at a monthly dose of 70 milligrams (mg) or 140 mg significantly reduced migraine frequency, the effects of migraines on daily activities, and the use of acute migraine specific medication over a period of 6 months. The long-term safety and durability of the effect of erenumab require further study."

Tepper, S. et al. (2017), "Interpretation: In patients with chronic migraine, erenumab 70 mg and 140 mg reduced the number of monthly migraine days with a safety profile similar to placebo, providing evidence that erenumab could be a potential therapy for migraine prevention. Further research is needed to understand long-term efficacy and safety of erenumab, and the applicability of this study to real-world settings."      

Based on the records the patient's migraines have been well controlled on the Aimovig for several years. This is a continuation of an effective therapy. Changing therapy carries risk of treatment failure. Therefore, Aimovig is medically necessary.                                                       

The formulary drugs are expected to cause adverse effects. 

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

The formulary drug is not expected to be effective.

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

The carrier's denial of a request for a Formulary Exception for Aimovig 140mg/mL (erenumab-aooe) is reversed.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Cholecystitis.
Treatment:  Inpatient admission.

The insurer denied coverage for inpatient admission.  The denial is upheld.
 
The patient presented to the Emergency Department with recurrent epigastric and right upper quadrant pain. She had been diagnosed with acute cholecystitis during a previous hospitalization but had declined surgery and was discharged on oral antibiotics. She returned to the emergency department with recurrent abdominal pain and underwent an uncomplicated laparoscopic cholecystectomy. The patient was discharged to home following an unremarkable postoperative course. 

The literature confirming the safety and efficacy of outpatient laparoscopic cholecystectomy (LC) has been well established. As Lillemoe et al. (1999) have noted, laparoscopic cholecystectomy has achieved universal acceptance as the "gold standard" for the treatment of cholelithiasis and cholecystitis. Many centers have utilized "short-stay" units for post-operative observation following a laparoscopic cholecystectomy. These authors retrospectively analyzed 130 consecutive patients undergoing LC in an outpatient surgery unit. There were no conversions to an open procedure. Eight patients (6.2%) were admitted to the hospital directly from the post anesthesia care unit (PACU), and 6 of these patients were discharged to home on post-operative day 1. An additional 6 patients (4.6%) required hospital admission following discharge from the PACU, and 3 of these 6 patients were also discharged on post-operative day 1. These authors concluded that laparoscopic cholecystectomy can safely and effectively be performed "as a true outpatient procedure with patients being discharged to home within hours of completion of the procedure". Less than 10% of patients will require hospital admission, and less than 5% of patients may require hospitalization following discharge to home. 

There is no documentation that the patient had a high risk of thromboembolism due to atrial fibrillation, a mechanical heart valve, or venous thromboembolism which would require inpatient anticoagulation. There is no documentation of perioperative or postoperative complications, co-morbid conditions, or hemodynamic instability that would require more intensive monitoring or management in the acute setting. The care that was received could safely and effectively have been performed on an outpatient basis. 

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for inpatient level of care is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Epigastric pain, vomiting.
Treatment:  Inpatient Hospital Admission.

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

This patient is an adult female with a past medical history of asthma, diabetes, and hypertension, who was brought by emergency services to the emergency department for urgent evaluation of severe and progressive epigastric pain, intractable nausea and vomiting for the previous three days. 

The patient stated that she was in a party three days prior to admission where she took marijuana and alcohol, and since that time she was having epigastric pain, six out of ten (6/10), non-radiating associated with bitterness in mouth and vomiting. She stated that she was vomiting five to six times in a day, food particles, no blood noted. The patient's hemoglobin and hematocrit were 15.5 and 48.4, respectively. She was treated with intravenous Zofran, Reglan, and Vancomycin, intravenous fluids, and her pain was managed with Ketorolac in the emergency room. Labs were significant for utox (urine toxicology) - positive for cannabinoid, glucose was 318, with a normal anion gap. The patient was managed with Zofran, Reglan, Ketorolac and intravenous fluid, and she tolerated very well. Ultrasound of the abdomen showed fatty liver, no biliary dilation and was unremarkable. The patient was discharged on a proton pump inhibitor (PPI) and was advised to quit smoking marijuana. The patient presented and was discharged 5 days later. On day #3, it was noted that the patient continued to complain of nausea / vomiting, and she had one episode of vomiting in the morning (small amount per patient). She was unable to tolerate food intake completely. She was on a liquid diet. On day #4, it was noted that the patient had mild epigastric pain and vomited once the previous night. She was advanced to a soft diet.

The proposed treatment was medically necessary.

The patient had ongoing nausea / vomiting beyond an observational level of care and was unable to drink fluids / consume solids appropriately. The patient also had co-morbidities which included uncontrolled diabetes. Therefore, the inpatient hospital admission was medically necessary.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: gastroesophageal reflux disease

Treatment: surgical procedure (Current Procedural Terminology (CPT) code 43284)

The insurer denied coverage for surgical procedure (Current Procedural Terminology (CPT) code 43284)

The denial is overturned

The patient has chronic gastroesophageal reflux disease (GERD). An endoscopy showed Los Angeles (LA) grade C esophagitis with Barretts at the gastroesophageal (GE) junction but no dysplasia. The patient had a Bravo capsule placed and the DeMeester score was 68.7. The patient has been on proton pump inhibitor (PPI) therapy but has continued to have symptoms. 

The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) conducted an updated Safety and Effectiveness Analysis of the Linx Reflux Management System in March 2017. With regards to safety, the conclusion was that long-term follow up supports the Food and Drug Administration (FDA) conclusion that the device is safe. With regards to efficacy there were several conclusions. The LINX implant results in Power of hydrogen (pH) (acidity level) normalization, improved quality of life, and cessation of regular PPI use on a consistent basis. When compared to laparoscopic fundoplication, rates of success in alleviating GERD symptoms and dysphagia are similar following LINX. The long term follow up data demonstrates that the LINX Reflux Management System is effective in the management of GERD. 

The Annals of Surgery 2019 Aug 270(2):302-308 has an article titled "Objective Evidence of Reflux Control After Magnetic Sphincter Augmentation: One Year Results From a Post Approval Study." The conclusion was that both safety and effectiveness of magnetic sphincter augmentation has been demonstrated outside of an investigational setting to further confirm the procedure as an appropriate treatment for GERD. 

The scientific literature supports the use of the LINX system as a treatment for GERD. The 2019 study in the Annals of Surgery confirms the long-term safety and efficacy of the procedure. The LINX system has been approved by the FDA. The patient is a good candidate since the patient has chronic GERD with significant esophagitis and a high DeMeester score and has had continued symptoms on long term PPI therapy. There are multiple options for treating GERD, but the LINX system has been shown to be both effective and safe. It is an appropriate procedure. 

In summary, the denial of surgical procedure (Current Procedural Terminology (CPT) code 43284) and coverage for the requested treatment should be overturned. This treatment is likely to be more beneficial than any standard treatments for this patient's condition and the adverse risk are not substantially increased over standard treatments.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: gastroesophageal reflux disease

Treatment: surgical procedure (Current Procedural Terminology (CPT) code 43284)

The insurer denied coverage for surgical procedure (Current Procedural Terminology (CPT) code 43284)

The denial is overturned

This case involves an adult patient diagnosed with gastroesophageal reflux disease (GERD) and Barrett's esophagus who was interested in the LINX procedure given the long-term use of proton pump inhibitors. The patient underwent esophagogastroduodenoscopy with biopsy of antrum with cold forceps for Helicobacter pylori (H. pylori) and gastroesophageal junction along with Bravo capsule placement. Findings included Los Angeles (LA) grade C esophagitis with irregular Z-line biopsy for Barrett's. The patient was negative for a hiatal hernia with Hill grade 2 valve. The endoscopic diagnosis was refractory heartburn with chronic reflux esophagitis with Barrett's esophagus. A barium swallow study completed and was unremarkable. 

The scientific evidence in peer-reviewed literature supports a result of improvement in health outcome.

The surgical procedure (Current Procedural Terminology (CPT) code 43284) has final approval from the appropriate regulatory bodies for this diagnosis.

This patient is a good candidate for surgical procedure (CPT code 43284).

The surgical procedure (CPT code 43284) is one of the best available treatments for this patient at this time.

The adverse risks are not increased over standard treatment/services.

The requested service is likely to be as beneficial or more beneficial than other standard treatments/procedures for this patient.

The submitted medical policy has stated that lower esophageal sphincter augmentation devices are considered investigational and not medically necessary for the treatment of gastroesophageal reflux disease (GERD) and for all other indications. Current medical literature has indicated that LINX is minimally invasive and has shown promising results of laparoscopic magnetic sphincter augmentation. Literature has noted that multiple studies have been conducted to determine the efficacy of an attic sphincter augmentation using the LINX reflux management system. Literature states that indications for this procedure include non-obese patients with GERD confirmed by 24-hour ambulatory Power of hydrogen (pH) (acidity level) monitoring and persisting symptoms after maximizing medical therapy. Records noted the patient had a longstanding history of GERD despite prolonged use of proton pump inhibitors. The LINX procedure was approved by the Food and Drug Administration (FDA) in 2012 for patients with gastroesophageal reflux disease. Given the extensive evidence in peer-reviewed literature, it was determined that the procedure would be beneficial to this patient.

In summary, the denial of surgical procedure (CPT code 43284) and coverage for the requested treatment should be overturned. This treatment is likely to be more beneficial than any standard treatments for this patient's condition and the adverse risk are not substantially increased over standard treatments.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Prostate Cancer. 
Treatment: CPT 78816 - Positron Emission Tomography and Computed Tomography (PET CT). 

The insurer denied coverage for CPT 78816 - Positron Emission Tomography and Computed Tomography (PET CT). 

The denial is overturned. 

This is the case of patient with prostate cancer for several years. Patient had surgery followed by salvage radiation therapy (RT). Recently patient had rising prostate specific antigen (PSA). 

Prostate-specific membrane antigen (PSMA) targeted Positron Emission Tomography (PET) imaging will assist in determining the location and the extent of the recurrent disease. The purpose of using PSMA-targeted PET imaging with piflufolastat F 18 injection is to detect and locate metastatic spread of cancer as piflufolastat F 18 binds to the prostate specific membrane antigen protein found on the surface of over 90% of prostate cancer cells. Based on the results of PSMA-targeted PET imaging with piflufolastat F 18 , they believe they will be able to recommend a more personalized and appropriate management plan for the patient. 

The National Comprehensive Cancer Network (NCCN) guidelines recognizes the role of PMSA tracers as a first line imaging tool for patients with biochemical recurrence of prostate cancer. 

Piflufolastat F 18 is a Food and Drug Administration (FDA) approved tracer for imaging prostate cancer. 

The Condor study reported that in 64% of patients, piflufolastat F 18 imaging resulted in changes in intended patient management. 

The Osprey study reported high levels of sensitivity and positive predictive value. 

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for CPT 78816 - Positron Emission Tomography and Computed Tomography (PET CT) is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: health failure, Parkinson's disease, vision impairment and rheumatoid arthritis.

Treatment: personal care aide (PCA) level 2 services: 168 hours/week, 12 hours per day x 2 x 7 days split shift.

The insurer denied coverage for personal care aide (PCA) level 2 services: 168 hours/week, 12 hours per day x 2 x 7 days split shift.

The denial is overturned.

 
This is an elderly patient with multiple medical problems that include health failure, Parkinson's disease, vision impairment and rheumatoid arthritis. She lives alone in a 1- bedroom apartment (husband died recently). The insurer approved personal care aide (PCA) level 2 services 8 hours/day, 7 days/week (56 hours/week) and the request is for 24 hours/day (split shift) 7 days/week; which is currently under review. 

According to the Uniform Assessment System (UAS) report, the patient's cognition is described as modified independent. Her ability to perform much of her Instrument Activities of Daily Living (IADL) tasks including meal preparation, ordinary housework and shopping range from total dependence to extensive assistance. She reportedly requires extensive assistance for bathing, personal hygiene, dressing, locomotion, toilet transfer/use and ambulation. She is independent with bed mobility and eating. The patient is frequently incontinent of bladder and continent of bowel.

The patient's clinical condition and functional deficits are at a level and unpredictable as to require the requested PCA services 7 days per week, 24 hours per day split shift. Letters from her treating physicians document her clinical condition and associated impairments. A live-in PCA may have been appropriate, however in her 1 bedroom apartment, it would not be feasible. Based on the clinical records, attention to the patient 's functional needs are more appropriately provided and maintained by increasing PCA services to 24 hours/day (split shift) 7 days/week. 

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for personal care aide (PCA) level 2 services: 168 hours/week, 12 hours per day x 2 x 7 days split shift is substantiated.