Persius/hicric huggingface dataset:
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's disease and chronic gastro esophageal reflux disease (GERD). 
Treatment: Magnetic sphincter augmentation procedure (LINX procedure) for the treatment of gastroesophageal reflux disease (procedure code 43284). 

The insurer denied coverage for magnetic sphincter augmentation procedure (LINX procedure) for the treatment of gastroesophageal reflux disease (procedure code 43284). 

The denial is overturned. 

The patient has Crohn's disease and chronic gastro esophageal reflux disease (GERD). He has been on long term proton pump inhibitor (PPI) use. He has had a workup which showed normal esophageal motility but with significant pathological reflux. He did not have a hiatus hernia. An esophagram revealed spontaneous gastroesophageal reflux to the level of the aortic arch. There was a discussion about doing anti-reflux surgery, but he was then referred for a LINX procedure. 

The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) conducted a Safety and Effectiveness Analysis of the LINX Reflux Management System. With regards to safety their 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 pH  [potential of hydrogen]  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 scientific evidence in the peer-reviewed literature supports the use of the LINX procedure. The procedure has FDA approval. The patient is a good candidate since he has had long-term symptoms of GERD while on PPI therapy. There are many procedures available for treatment of GERD. However, the LINX system has been shown to be successful in treating this condition. The procedure has been shown to be safe. It will likely be more beneficial for this patient. The adverse risks are not increased. 

The carrier's denial of the magnetic sphincter augmentation procedure (LINX procedure) for the treatment of gastroesophageal reflux disease (procedure code 43284) should be overturned.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Plasma cell tumo.
Treatment:  radiation therapy for multiple myeloma phase 1: 25 fractions (treatment sessions) of proton beam therapy image guided radiation therapy (IGRT).
The insurer denied radiation therapy for multiple myeloma phase 1: 25 fractions (treatment sessions) of proton beam therapy image guided radiation therapy (IGRT).
The determination is upheld.

This patient has a significant history of a destructive mass at thoracic (T) 7-8 with spinal cord compression post laminectomy several year ago. This was a plasma cell tumor. A bone marrow biopsy was negative for myeloma. She was then treated with radiation therapy to this area to total dose of 30 gray (Gy) in 10 treatments. She had no systemic therapy and was lost to follow up. She now has new progressing pain in the left posterior chest. She was found to have a new destructive mass involving the T8 posterior rib. Palliative radiation therapy is recommended for this recurrent plasma cell tumor and the proton beam approach is requested to deliver 50 Gy in 25 treatments.
At issue is the medical necessity of the requested treatment.

No, the requested treatment of radiation therapy for multiple myeloma phase I of 25 treatments of proton beam therapy and image guidance is not medically necessary for this patient.
The recommended proton beam radiation therapy for palliation of this patient is not medically necessary as conventional photon beam radiation therapy with intensity modulated radiation therapy (IMRT) approach can safely irradiate the new T8 rib lesion that is near a previously irradiated area at T7-8 vertebral bodies. This treatment is palliation and the critical vital structures in this area include the spinal cord and normal lung tissue. There are a lack of any significant studies published in peer reviewed journals supporting the benefits and safety of proton beam radiation therapy in this clinical scenario. This is not medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Coronary heart disease, diabetes mellitus, heart failure.

Treatment consumer directed personal assistance program (CDPAP) of 9 hours per day, 7 days per week for a total of 63 hours per week.

The insurer denied coverage for consumer directed personal assistance program (CDPAP) of 9 hours per day, 7 days per week for a total of 63 hours per week.

The denial is overturned.

The patient has a history of coronary heart disease, diabetes mellitus, heart failure, cerebral atherosclerosis, vascular dementia, hemiplegia following a cerebral infarct, chronic kidney disease (Stage 4), hyperlipidemia, atrial fibrillation and benign prostatic hyperplasia. Per the New York State Department of Health's Uniform Assessment System (UAS-NY), the patient, his wife and consumer directed personal assistance program aide were present. The patient lives with his spouse in a two-bedroom apartment on the first floor of a building with elevator access. He was in SAR [subacute rehabilitation] for a few days. The patient was hospitalized for a urinary tract infection. Later, he fell on his knees while walking on the street. Emergency medical services came and took him to the hospital. No injuries were reported. The patient is currently receiving physical therapy twice a week. He was hospitalized due to generalized weakness

He is totally dependent for meal preparation, ordinary housework, managing finances and shopping. The patient needs maximum assistance with managing medications, phone use, managing stairs, transportation, bathing, personal hygiene, dressing his upper and lower body, locomotion, toilet transfer and toilet use. He is noted to walk ad lib [as needed]. The patient's bladder continence is controlled with a cystotomy to drain his urine. He is frequently bowel incontinent and uses under pads and pull-ups. He needs extensive assistance with bed mobility and eating. The patient uses an assistive device for locomotion. 

An increase to consumer directed personal assistance program (CDPAP) from 6 hours per day to 9 hours per day, 7 days per week for a total of 63 hours per week is being requested.  The patient has been evaluated twice and was assessed at needing 60 and 56 hours/week. He needs a high degree of hands-on assistance, and his wife and doctor's note he is weaker. The patient's request for 63 hours/week is in keeping with that assessed for in the Tasking tools. 

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 Consumer Directed Personal Assistance Program (CDPAP) of 9 hours per day, 7 days per week for a total of 63 hours per week is overturned. Medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Cardiac/Circulatory 
Treatment: Home Health Care 
The insurer denied increase in personal care hours to 168 hours per week. 
The denial is upheld.

The patient is a female with past medical history significant for atrial fibrillation, congestive heart failure, pulmonary hypertension, status post pacemaker, automatic implantable cardioverter defibrillator (AICD), myeloma, rheumatoid arthritis, asthma, coccyx ulcer, sleep apnea, dementia and gastric carcinoma stage three. The patient was partially approved for 7 days a week, 24 hours a day live-in service, a total of 91 hours a week. The patient is requesting 24 hours per day continuous care by more than one person (168 hours per week).

This review is for the medical necessity of the requested increase in hours.

The requested health service/treatment of increase in personal care worker (PCW) service to 7 days per week, 24 hours per day continuous care by more than one person (168 hours per week) is not medically necessary for this patient.

Personal Care Assistance (PCA) services beyond the 91 hours a week is not medically necessary. Documentation provided did not support additional services beyond 91 hours a week.

Services were denied by her insurance based upon the following rationale: The member's newly approved level of care is enough to meet her needs. The member's Activities of Daily Living (ADLs) and nighttime needs such as grooming, dressing, bathing, locomotion, transferring, toileting, meal preparation and feeding are sufficiently infrequent and can be safely and adequately met through the combination of her currently approved 7 days per week, 24 hours per day, live-in, 91 hours per week of Personal Care Worker (PCW) hours coupled with the plan's coordinating her care with the appropriate medical professionals and specialized equipment as medically appropriate, and continuous monitoring of her needs in the community.

All documents provided for review including appeal letter, physician statement, and care log were reviewed. The Uniform Assessment System (UAS) was reviewed.

The patient is an elderly female with multiple medical problems requiring significant care in both activities of daily living (ADLs) and instrumental activities of daily living (IADLs). The patient has scheduled needs and unscheduled needs. The scheduled needs are allotted for with a total of 70 hours a week of personal care worker (PCW) hours. These hours are sufficient to meet the patient's care needs. There is an additional 21 hours a week allotted for unscheduled care based upon the plan covering a total of 91 hours a week. There was no notation that there was not time available for the aide to get at least 5 hours of uninterrupted sleep. Changes in her PCW hours may be appropriate, however at this time documentation was not provided to support this.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohn's Disease
Treatment: Remicade 
The insurer denied Remicade as not medically necessary.
The denial is overturned.

The patient has a history of severe Crohn's disease and has previously tried and failed conventional therapies. The patient was then started on Remicade (infliximab) and had a partial response which required dose escalation to 10 milligrams per kilogram (mg/kg) every 4 weeks.

Continuation of Remicade is medically necessary.

Remicade is Food and Drug Administration (FDA) approved for the treatment of pediatric Crohn's disease and ulcerative colitis. The clinical practice guidelines recommend the use of Remicade (infliximab) in patients with severe disease or in patients who do not respond adequately to conventional therapy. The safety and efficacy of infliximab are well established and supported by a large body of medical literature. Therefore, the requested treatment is consistent with the generally accepted practices and is medically appropriate.

The health plan policy approves Remicade for the treatment of Crohn's disease and approves continuation of the medications for patients who have achieved remission. The patient has a history of Crohn's disease and has been well controlled on Remicade for years. Therefore, the continuation of Remicade is medically necessary.

In terms of the requested dose, the dose is higher than the FDA approved dose. However, the dose is medically necessary. It is very common for patients with Crohn's disease to lose response to their biologic over time or to require higher than standard dosing. The standard practice in the management of inflammatory bowel disease to try to rescue the treatment by increasing the dose and/or the frequency (dose escalation).

There are many peer-reviewed literature reports showing that low infliximab levels were associated with poor clinical response. The experience with dose escalation of Remicade has been extensive in both adult and pediatric patients. The available scientific evidence strongly supports the safety and efficacy of this approach.

According to the clinical practice guidelines: "Intravenous administration of infliximab (Remicade) is usually at 5 mg/kg with three induction doses over 6 weeks [weeks 0-2-6], followed by maintenance therapy of 5 mg/kg every 8 weeks. However, there is ample evidence that children less than 30 kg, and those with extensive disease and low serum albumin levels, require higher induction doses up to 10 mg/kg, shorter dosing intervals, or both, to reach target trough levels" (Van Rheenen, et al).

This patient failed to adequately respond to the lower doses of infliximab and responded well to the requested dose. Therefore, continuation of Remicade as requested is medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Multilevel lumbar degenerative changes

Treatment: Personal care services (PCS) 10 hours a day, 7 days a week

The insurer denied coverage for PCS 10 hours a day, 7 days a week.

The denial is overturned. 

This male patient has a history of hypertension, congestive heart failure, diabetes type 2, chronic kidney disease stage 4, atherosclerotic heart disease, dementia, spinal stenosis, and multilevel lumbar degenerative changes.

The patient required assistance with most of his activities of daily living and had been debilitated for years with chronic back pain and generalized weakness.  The symptoms had become more severe in the past few months.  The patient had become more forgetful.  The patient now spent approximately 90% (percent) of his waking hours lying on the sofa to alleviate neck and back discomfort.  The patient was too weak to stand up/transfer to bed and must therefore sleep on the sofa until the home health aide returned.  The patient's upper extremities were weak, and he cannot use a wheelchair to self-propel.  The patient was still able to feed himself using a lightweight utensil.  He was no longer able to get up and answer the door.  The 2 home health aides had been given a house key so they could enter and leave on their own.  The patient currently received home health aide 8 hours/day 7 days/week.  The provider was requesting that the home health aide hours be increased to 10 hours/day 7 days/week.  This would allow the home health aide to transfer the patient to his bed at night and allow him to safely use the commode during the day.  

10 hours a day, 7 days a week is medically necessary for this patient based on his current medical conditions, chronic pain and severe debility.  He is at high risk for falls with its accompanying complications and with his history of dementia he would be more prone to confusion in the evenings, when there would be no one there to help.  It would be much safer for him to be put in bed before the aide leaves at night.  A diaper worn at night would help him avoid getting up to the commode in the middle of the night when he would be more prone to accidents.  Having the help he needs will also help him stay in his home as long as possible.  This would contribute positively to his mental health and well-being.

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

The carrier's denial of coverage for personal care services (PCS) 10 hours a day, 7 days a week is overturned.  The medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Parkinson's Disease
Treatment: Consumer Directed Personal Assistance Services (CDPAS): 24 Hour Live-In, 7 Days per Week
The insurer denied CDPAS: 24 Hour Live-In, 7 Days per Week.
The health plan's determination is overturned. 

The patient is a male with past medical history of Parkinson's disease, advanced dementia, nonverbal, anxiety, coronary artery disease, Crohn's disease, hypertension (HTN), gastroesophageal reflux disease (GERD), anemia, congestive heart failure (CHF), bowel incontinence and urinary incontinence who had been assigned Consumer Directed Personal Assistance Services (CDPAS) services. At this assessment, the patient was assessed at total assistance with tasks of meal preparation, ordinary housework, managing finances, managing medication, phone use, shopping, transportation, and equipment management while maximum assistance with tasks of stairs, bathing, personal hygiene, dressing upper/lower body, transfer toilet, and toilet use. With task of walking and locomotion the patient was assessed at extensive assistance, while limited assistance with bed mobility. The patient had a fall with hip fracture with subsequent open reduction internal fixation (ORIF). There was a request to increase PCA (personal care assistance) services and the patient underwent a telephonic assessment tool, assessing the patient at total assistance with all tasks except for managing medication, dressing lower body, transfer toilet, toilet use for which she was assessed at maximum assistance. The patient was assessed at extensive assistance with task of bed mobility. The patient had a follow-up with orthopedics, who noted the patient needed assistance with all activities of daily living (ADLs).

The CDPAS: 24 Hour Live-In, 7 Days per Week is medically necessary for this patient.

There is documentation of worsening physical and mental functioning since patient's fall with fracture. The patient requires at least extensive assistance with all ADLs and instrumental activities of daily living (IADLs). The patient has unscheduled and unpredictable care needs that span a continuum of time and the insurer has failed to provide a plan to meet these unscheduled and unpredictable care needs. The requested increase in CDPAS services is not solely for safety and supervision but to assist the patient with safe completion of ADLs and IADLs. The patient's care needs cannot be met solely with medical supply and adaptive equipment. The patient does not have informal help outside of the hours that he currently has services. The patient's medical provider has documented medical necessity of increased CDPAS services. 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, CDPAS: 24 Hour Live-In, 7 Days per 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 his own home.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Digestive System/Gastrointestinal. 
Treatment: Inpatient hospital. 
The denial is upheld. 

The patient is a female who presented to the hospital with abdominal pain and diarrhea of 2-days duration. Past medical history includes diabetes, asthma, bipolar disorder, and cystic kidney disease. At the time of presentation, the patient was without fever, heart rate was normal and systolic blood pressure was elevated. She was tender in the right upper abdomen. The white blood cell (WBC) count was normal at 10 thousand (K). The complete metabolic panel identified elevated serum transaminases and alkaline phosphatase with normal bilirubin. Computed tomography (CT) scan showed gallstones. Abdominal ultrasound showed gallstones.
The patient was admitted to the hospital and started on intravenous (IV) antibiotics. Hepatobiliary iminodiacetic acid (HIDA) scan was performed showing normal visualization of the liver, gallbladder, and bowel.
The patient underwent laparoscopic cholecystectomy. The operative dictation describes findings of acute cholecystitis. The patient was treated with post-surgical monitoring, IV fluid, IV analgesia, and antiemetics. The immediate post-surgical recovery was uncomplicated.  Post-operative day #1 following surgery, the patient had stable vital signs. Pain was controlled. The diet was advanced. Lab data showed a trend toward normalization of the liver enzymes. The patient remained clinically stable and was discharged from the inpatient setting. The subject under review is the medical necessity for the inpatient stay.

There is no compelling reason why this patient could not have safely and appropriately been treated at a lower level of care. Based on the submitted clinical documentation, an inpatient level of care was not medically necessary. This patient was admitted to the hospital with the diagnosis of cholelithiasis/cholecystitis. The patient underwent an uncomplicated laparoscopic cholecystectomy procedure. There is no documentation of hemodynamic, pulmonary, neurological, or metabolic reason for an acute inpatient level of care. Additionally, there is no documentation of failure to achieve discharge criteria, conversion to open surgery, care for comorbidities, procedural complications, or any other condition requiring inpatient admission. There were no peri-operative complications or other clinical issues. She remained stable and was discharged from the hospital.
Inpatient level of care was not medically necessary. A lower level of care would have permitted for the pre-surgical assessment, the surgical procedure, and perioperative IV fluid, IV antibiotics, IV antiemetics, and post-surgical monitoring. The patient was clinically stable following surgery as supported by the corresponding medical records. The medical record supports that the patient could have been reasonably and appropriately treated at a lower level of care status.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Reynaud's syndrome.
Treatment: Sildenafil.
The insurer denied the Sildenafil.
The denial is overturned.

The patient is a female with scleroderma diagnosed, complicated by Raynaud's syndrome with digital skin breakdown, refractory hypertension, GERD (gastroesophageal reflux disease), hiatal hernia, and shortness of breath.

For her Raynaud's symptoms, the patient failed treatment with the calcium channel blocker amlodipine, 10 mg (milligrams) daily. The provider wishes to now prescribe sildenafil 20 mg (milligrams) twice daily for the treatment of Raynaud's syndrome.

Coverage for Sildenafil was denied by the health plan for this patient, because there is no documentation of a diagnosis of pulmonary hypertension. The appeal is for sildenafil for the treatment of scleroderma-associated Raynaud's syndrome with digital skin breakdown.

Yes, the requested Sildenafil is medically necessary.
Sildenafil 20 mg (milligrams) is FDA (United States Food and Drug Administration)-approved for the treatment of pulmonary hypertension.  It is not FDA (United States Food and Drug Administration)-approved for the treatment of Raynaud's syndrome, as requested for this patient.  This patient has scleroderma complicated by Raynaud's syndrome with digital skin breakdown, and has failed treatment with a calcium channel blocker (amlodipine 10 mg [milligrams] daily).

Per a recent UpToDate review, for patients with Raynaud's syndrome in whom calcium channel blockers cannot be administered, alternative options include phosphodiesterase (PDE) type 5 inhibitors, such as sildenafil.  A meta-analysis of six randomized trials including 244 patients with secondary Raynaud's syndrome (such as this patient with scleroderma) found that there was a modest benefit of PDE (phosphodiesterase) inhibitors on the frequency and duration of Raynaud's attacks.  Therefore, the proposed sildenafil is medically necessary for the treatment of this patient with scleroderma-associated Raynaud's syndrome who has failed treatment with amlodipine.

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