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

Diagnosis: Cancer (Hodgkin's Lymphoma)
Treatment: Proton Beam Radiation Therapy
The insurer denied the Proton Beam Radiation Therapy.
The denial is upheld. 

The patient is a female with a diagnosis of stage IIAX Hodgkin's Lymphoma involving the cervical and mediastinal nodes status post (s/p) systemic therapy.  Consolidative radiation therapy to a dose of 36Gy was recommended, and proton beam radiation therapy was requested.

No, the proposed treatment with proton beam radiation therapy is not medically necessary.

In this case, the patient is a female with a diagnosis of stage IIAX Hodgkin's Lymphoma involving the cervical and mediastinal nodes s/p systemic therapy.  Consolidative radiation therapy to a dose of 36Gy was recommended, and proton beam radiation therapy was requested.  However, based upon and in conclusion of this review, proposed treatment is not considered medically appropriate for this individual under these unique circumstances. 

Proton beam radiation therapy is a type of very precise external radiation treatment in which protons are used to treat cancer and other conditions.  Compared to photon, a proton beam that is delivered with sufficient energy has a low "entrance dose".  A proton beam also has a high-dose "Bragg peak" region, which is designed to cover the entire tumor and there is no "exit dose" beyond the tumor involved in proton radiation therapy.  Because of this unique property, proton beam therapy is highly successful in minimizing damage to normal tissue and surrounding organs, resulting in fewer side effects.  Proton beam radiation therapy has been shown to be safe and effective for any central nervous system (CNS) lesions that are adjacent to critical structures such as optic nerve, base of skull, brain stem or spinal cord.  It has also been shown to be a very useful procedure when re-irradiation is required, or when sparing of the surrounding critical structures cannot be done adequately with other types of radiation therapy.  It is an FDA approved procedure and it is not subject to institutional review board (IRB) review.

Although there are studies showing possible dosimetric advantage of proton beam therapy for the treatment of lung/mediastinal disease, there is inadequate clinical data showing its safety and efficacy.  There are currently ongoing trials still evaluating the role of proton therapy for lymphomas.  

In this case, a proton/photon comparison plan was provided.  The proton plan was able to reduce radiation dose to the heart, lung, esophagus, spinal cord and breasts, however, the doses to those structures were all within tolerance per Quantec limits and Radiation Therapy Oncology Group (RTOG) guidelines for both the photon plan and proton plan.   

Although there are single institution trials and case series showing that proton therapy is safe and effective for the treatment of lymphomas, there is inadequate clinical data from well conducted randomized trials showing that proton therapy is clinically superior in comparison to photon therapy.  Therefore, the proposed proton beam radiation therapy is not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Orthopedic/Musculoskeletal-Osteoarthritis
Treatment: Home Health Care
The health plan denied the increase in Personal Care Service as not medically necessary. The reviewer has upheld in whole the health plan's determination.

The patient has multiple past medical problems, most notably osteoarthritis, chronic back pain, and generalized debility.
The patient requests personal care service level to increase from 70 hours per week to 22 hours per day, 7 days per week for a total 154 hours per week. The patient was approved for 12 hours per day, 7 days per week, total 84 hours per week.

There is no documentation provided to support the necessity of additional services in excess of 84 hours per week, 7 days per week 12 hours per day. There is no documentation provided to support services specifically needed during the nocturnal hours.
This patient has a past medical history significant for heart disease, osteomyelitis, osteoarthritis, hypertension, spinal fusion, kyphosis, and anxiety.
The patient was able to feed themselves when meals were pre-prepared. Patient was able to do personal care with limited assistance. Patient needed maximal assistance for bathing and dressing the lower body. Patient has a walker and wheelchair, shower chair and raised toilet seat with rails. Patient is able to walk with assistance. Patient was receiving 70 hours per week and was approved for 84 hours per week, 12 hours per day 7 days per week. No overnight needs were noted.
The most recent Uniform Assessment System (UAS) State of New York recommended 46.22 hours. Previous UAS State of New York and previous Tasking tool were all reviewed.
Patient is currently receiving 84 hours per week of services. The documented need is 46.22 hours as of the most recent UAS. There was a notation that the patient's medical status has declined since the last evaluation. The patient currently has an aide for 12 hours per day, 8 AM to 8 PM. However, there is no specific documented need for nocturnal services. The patient currently has a Foley catheter, per the medical documentation. This does not need to be changed or emptied in the middle of the night. Patient has no bed sores or other medical needs noted which necessitates personal care services during the nocturnal hours. Typically, people sleep in the middle of night and do not need to be turned by an aide for medical reasons unless there is an active bed sore or other specific issue. Therefore, urinary incontinence management is not necessary during the nocturnal hours secondary to the catheter. There is no noted bedsores or other medical conditions which would necessitate frequent turning in the middle the night.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Appendicitis 
Treatment: Inpatient Hospital Stay 

The insurer denied the inpatient hospital stay. The determination is upheld. 

The patient presented to the emergency room (ER) with gradually worsening, moderate, crampy, burning periumbilical pain radiating to the lower abdomen. She did have associated nausea and vomiting. The patient's white blood cell count was 20.29. A computed tomography (CT) scan demonstrated acute appendicitis, and hepatic steatosis. The patient was taken to surgery that evening and underwent an uneventful laparoscopic appendectomy. She was discharged home the next day. At issue is the medical necessity of an inpatient stay. 

The inpatient stay was not medically necessary. The patient had acute appendicitis without perforation, but did not have evidence of other complications. She did well after surgery and was able to be discharged the next day. There is no evidence that additional complex testing or therapy other than the surgery was performed. There is no evidence that a complicating event occurred before, during, or after the procedure that required a higher level of care. There is no documentation that the treating team identified conditions or problems specific to the patient that would have required inpatient care. The patient did not have significant dehydration, hemodynamic instability, severe pain requiring frequent or high doses of narcotics, signs of intestinal obstruction, peritonitis, or bacteremia. The provided documentation does not support the medical necessity of inpatient level of care.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Polyarthritis.
Treatment: Intravenous immunoglobulin (IVIG) infusion therapy.
The insurer is denied coverage for intravenous immunoglobulin (IVG) infusion therapy.
The denial is overturned.

This is a male patient with a history of polyarthritis of the hands, hips, shoulders, knees and ankles. It was reported that the patient had chronic cyclic vomiting that was felt to be an autoimmune condition. It was noted that the patient had failed multiple therapies. The patient was recently placed on Plaquenil for this condition. The patient's provider suspected that a systemic autoimmune process was occurring due to the presence of arthritis and gastropathy. Approval was being sought by the patient's Gastroenterology (GI) and Rheumatology for IVIG therapy.

Autoimmune Cyclical Vomiting is a subset of the cyclical vomiting syndrome. It is rare.
According to Flanagan et al (2014) study, there was noted relief with IVIG therapy in 74% of 23 patients (recruited over 9 years). Baffy, et al. reported on 13pts of whom 71% had subjective improvement with IVIG. There is no reasonable expectation of large studies given the small number of patients, and the rarity of this condition. There is no FDA-approved treatment for cyclic vomiting. Intravenous immunoglobulin (IVIG) is normally not a treatment for cyclical vomiting syndrome, but in the autoimmune case there is at least as good if not better evidence for IVIG as there is for other supportive therapies. In this case, this patient has tried and failed several conservative therapies. Thus, due to the rarity of this patient's condition and the lack of evidence-based, standard of care treatment for this patient, IVIG infusion therapy is considered medically necessary for this patient.

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

The carrier's denial of coverage for Intravenous immunoglobulin (IVIG) infusion therapy should be overturned. The medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Cholecystitis
Treatment: Inpatient hospital admission

The insurer is denied coverage for inpatient hospital admission. The denial is upheld. 

This is a female patient with a history of gallstones. She was sent to the emergency department (ED) from the radiology department with complaints of burning right upper quadrant (RUQ) abdominal pain, nausea and vomiting, and concern for cholecystitis. The patient presented to the ED as she was sent from radiology for acute cholecystitis. Her vital signs were stable, and she was afebrile. The patient had an ultrasound that showed gallstones and thickened gall bladder suspicious for cholecystitis. Exam revealed RUQ tenderness wit positive Murphy's sign. Surgery was consulted. The findings suggest chronic cholecystitis. WBC was 6.85. LFT's we re normal. The patient underwent an uneventful laparoscopic cholecystectomy. The patient tolerated the procedure well, without complications. The patient was tolerating a diet and was discharged to home. 

Based upon the records medical necessity of inpatient admission was not justified at an acute level of care as this patient did not have acute cholecystitis based upon ultrasound. Furthermore, she did not have a HIDA scan to confirm cholecystitis. The repeat sonogram did not show signs of acute cholecystitis but rather chronic cholecystitis and therefore the patient had biliary colic. She did not have elevation of liver enzymes to the point that she required inpatient admission. She presented to the hospital and was kept in the hospital for a lap cholecystectomy the following day and then discharged later that day. All of this could have been done as noted by the insurer under an observation status. 

The health care plan did act reasonably and with sound medical judgment and in the best interest of this patient. This patient could have been treated on an observation status and inpatient admission was not medically necessary.

Based on the above, the medical necessity for the inpatient hospital admission is not substantiated. The insurer's denial is upheld.
Appeal type: Medical necessity
Decision: Overturned

Gynecological
Inpatient Hospital

Diagnosis: Vaginal Bleeding
Treatment: Inpatient stay. The insurer denied the inpatient stay. The health plan's determination is overturned. 

This is a female patient who presented to the emergency department with the complaint of "abnormal heavy bleeding during periods, irregular periods x 1 year". She reported tunneling vision, dizziness, and lightheadedness after 15 days of vaginal bleeding. The included medical records report the passage of clots as well as needing to change sanitary pads every 30 minutes to 1 hour with the use of 12-15 pads a day including 6 at night. 

The inpatient hospital admission was medically necessary for this patient.
Normal menstruation in adolescent girls includes a menstrual cycle interval of 21-45 days with a flow length of 7 days or less and three to six pads or tampons a day. Per ACOG, "menstrual flow requiring changes of menstrual products every 1-2 hours is considered excessive, particularly when associated with flow that lasts more than 7 days at a time". This patient meets the definition of excessive and abnormal uterine bleeding given her history of cycles of vaginal bleeding lasting 20 days and requiring up to 15 sanitary pads per day.
Per ACOG, adolescent girls who present with heavy menstrual bleeding should include assessment of anemia, the presence of an endocrine disorder leading to anovulation, and evaluation for the presence of a bleeding disorder.
Appeal type: Medical necessity
Decision: Upheld

Diagosis: Parkinson's disease, prior strokes, traumatic brain injury (TBI) and gait ataxia
Issue under review: Personal Care Aide 7 Days x(2) 12 Hour Split Shift

Determination:
The Personal Care Aide 7 Days x(2) 12 Hour Split Shift is not medically necessary.

The patient is an elder female with a history of Parkinson's disease, prior strokes, traumatic brain injury and gait ataxia. Due to impairments related to these conditions, she requires assistance for completion of the majority of her activities of daily living (ADLs). However, a recent face to face assessment of the patient was completed, which indicated that the patient is alert and oriented but supervision is required at all times. The patient in unable to walk well and since there is no viable safety plan in case of an emergency such as a fire, nursing home placement  would be a much safer and more appropriate option. For these reasons, the proposed treatment of an increase in Personal Care Aid hours to 7 Days x(2) 12 Hour Split Shift is not deemed medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Endocrine
Genetic Testing

Diagnosis: Thyroid Nodule
Treatment: Genetic testing
The insurer denied the genetic testing. The health plan's determination is upheld. 

This is a male who underwent a hemithyroidectomy with isthmusectomy. A fine needle aspiration was performed on a nodule on the left side. Pathology demonstrated papillary carcinoma (classic), with papillary micro carcinoma with Hurtle cell carcinoma. ThyraMIR gene classifier testing was recommended and is under review.

The Genetic Testing: ThyraMIR is not medically necessary for this patient.
According to Bose et al, fine needle aspiration biopsy is able to distinguish benign from malignant nodules with high sensitivity and specificity; however, 20% to 30% of nodules are diagnosed as indeterminate with a risk of malignancy varying from 10% to 75% based on the 2017 revision of the Bethesda System for Reporting Thyroid Cytopathology.
In a review of the literature by Liu, the authors concluded that over half of nodules with gene classifier-suspicious results still require further validation like molecular markers, diagnostic surgery, or long follow-up, which limits its use in future clinical practice. In a study by Marti et al, there were wide variations in the gene classifier-benign call rate across two  tertiary referral cancer centers which had differing rates of malignancy in indeterminate thyroid nodules.  
In a review of the literature by Duh, the authors concluded that the quality of gene classifier methods has not been rigorously examined. and future studies should define and assign a "true negative" label to gene classifier-benign nodules that do not develop malignant signs or symptoms during a pre-specified period of follow-up, and these nodules should be included in calculations of diagnostic accuracy.

Therefore, based upon the peer reviewed medical literature, the Genetic Testing: ThyraMIR is not medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Pyelonephritis.
Diagnosis:  Inpatient admission.

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

The patient is a female whose inpatient admission is under review.  The patient has a history of DM (diabetes mellitus), ETOH (alcohol) and opiate abuse, in treatment for rehab, complicated by pyelonephritis.  She was initially treated with Macrobid, then cipro, but without resolution of symptoms.  Her presentation was positive for nausea, lightheadedness, and suprapubic fullness/pain.  She had no fever.

In the ER, the patient's vitals were significant for the following: T (temperature) - 98.0, P (pulse) - 77, RR (respiration rate) - 20, BP (blood pressure) - 136/84.  On general examination, the patient was NAD (no acute distress).  Examination of the patient's chest, CVS (cardiovascular system), and abdomen were normal.  Examination of the patient's back was significant for right CVA (costovertebral angle) tenderness.

The patient's labs were as follows: WBC (white blood count) - 11.7 (HIGH), Hg (hemoglobin) - 13.3, HCT (hematocrit) - 37.6, Plt (platelets) - 249, Na (sodium) - 129 (low), K (potassium) - 3.4, Cl (chloride) - 90, CO2 (carbon dioxide) - 27, BUN (blood urea nitrogen) - 10, and Cr (creatinine) - 0.7.

The patient's UA (urinalysis) was negative.  Urine culture revealed <10,000 CFU (colony forming units).

Yes, the Inpatient admission was medically necessary.

Outpatient treatment for pyelonephritis in women is given for uncomplicated cases (1).  In this patient the pyelonephritis was complicated, as the patient had failed two prior outpatient treatments.  In addition, standard of care would also require inpatient admission and treatment of such a patient.  Thus, this admission was warranted and supported by standard of care and IDSA guidelines.  Failure to admit such as a patient can lead to loss of function, septic shock, or death.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Degenerative Disc Disease

Treatment: 22899, unlisted procedure, spine (INTRACEPT Procedure) and C9752 (destruction of intraosseous basivertebral nerve, verts two vertebral bodies, including imaging guidance, lumbar/sacrum).

The insurer denied the 22899, unlisted procedure, spine (INTRACEPT Procedure) and C9752 (destruction of intraosseous basivertebral nerve, verts two vertebral bodies, including imaging guidance, lumbar/sacrum). 

The denial was overturned.

This is a male patient who is been recommended to undergo the requested procedure due to a diagnosis of low back pain.  The documentation indicates that the patient has low back pain that has been present for over a year.  The documentation indicates that the patient has had treatment with steroid injections as well as physical therapy, medication, radiofrequency ablation and the application of heat.  The documentation indicates that the patient has also been diagnosed with anemia and therefore cannot utilize anti-inflammatory medications.  The patient's pain has worsened over the last several months and he complains of constant aching pain that is exacerbated with increased physical activity.  The patient has had a prior magnetic resonance imaging (MRI) that showed Modic type II changes at L2-L3 and L4-L5 disc spaces.  The physician detailed that the patient has exhausted all traditional nonoperative measures to resolve his pain and therefore, recommended that the patient undergo a basivertebral nerve ablation.  The documentation indicates that the patient had complaints of low back pain as well as bilateral knee pain.  The physical exam revealed decreased range of motion to the bilateral knees with edema.  There were no significant abnormalities noted.  It was recommended that the patient continue to utilize medications to participate in physical therapy pertaining to his knee pain.

Based on the review of the literature, there is scientific evidence that supports a result of improvement in health outcome with this requested procedure, Intracept.  As per the documentation submitted for review, this patient has failed conservative treatment with physical therapy and medications.  The patient has exhausted all nonoperative treatments.  This patient is considered an appropriate candidate for this procedure.

The requested service is likely to be more beneficial than any of the standard treatments/procedures for this patient. 

The carrier's denial of 22899, unlisted procedure, spine (INTRACEPT Procedure) and C9752 (destruction of intraosseous basivertebral nerve, verts two vertebral bodies, including imaging guidance, lumbar/sacrum) should be overturned.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Degenerative Disc Disease

Treatment: 22899, unlisted procedure, spine (INTRACEPT Procedure) and C9752 (destruction of intraosseous basivertebral nerve, verts two vertebral bodies, including imaging guidance, lumbar/sacrum).

The insurer denied the 22899, unlisted procedure, spine (INTRACEPT Procedure) and C9752 (destruction of intraosseous basivertebral nerve, verts two vertebral bodies, including imaging guidance, lumbar/sacrum). 

The denial was upheld.

This is a male patient with a history of low back pain, bilateral primary osteoarthritis of knee, vertebrogenic pain, facet arthropathy, lumbar and long-term prescription opiate use. The patient's magnetic resonance imaging (MRI) report stated that this patient has type II Modic changes at L2-3 and L4-5 and type III Modic changes at L5-S1. The patient was found to have lesions in his small intestine and had to discontinue non-steroidal anti-inflammatories (NSAIDS) use for his pain management. The patient has tried steroid injections, physical therapy, medication, radiofrequency ablation and sitting in a hot tub. However, the patient's pain significantly worsened affecting his activities of daily living (ADLs).  The physician advocates for radiofrequency ablation (RFA) of the basivertebral nerves at two levels.

Studies such as Fischgrund et al (2018) and (2019) provide clinical evidence that patients with Type I or Type II Modic changes of the treated vertebral bodies show clinically meaningful improvement at 3 months with radiofrequency ablation (RFA) of the basivertebral nerve and is maintained through 2 years. Becker et al's clinical trial (2017), which was an industry-sponsored study, showed that the patient-reported outcomes measures noted by Visual Analogue Scale (VAS) and Osewestry Disability Index (ODI) were significant improvement after RFA treatment at 3-month follow-up and at 12-month follow-up. However, this study was limited by small sample size (i.e. 17 patients), lack of randomization and control, and short-term follow-up.

Despite these positive clinical studies, studies such as Khalil et al (2019) found that though patient-reported outcomes such as low back pain significantly decreased with RFA procedure, it did not affect the patient's opiate consumption. This prospective randomized trial found that follow-up was very limited in the standard care patients in the final analysis because of limited results collected up to the point of cross-over or study exit. 

The requested service is not likely to be more beneficial than any of the standard treatments/procedures for this patient.

The carrier's denial of 22899, unlisted procedure, spine (INTRACEPT Procedure) and C9752 (destruction of intraosseous basivertebral nerve, verts two vertebral bodies, including imaging guidance, lumbar/sacrum) should be upheld.