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

Diagnosis: Back pain
Treatment: Intraosseous basivertebral nerve ablation
The health plan denied: Intraosseous basivertebral nerve ablation
The determination is: Upheld

The patient has low back pain. Pain began several years ago. Prior treatment has included home exercises, injection medications and physical therapy. The patient has tried multiple medications, including Gabapentin, muscle relaxants, and Ibuprofen. Pain is rated 8 out of 10. Her pain affects activities of daily living (ADL). A magnetic resonance imaging (MRI) of the lumbar spine showed degenerative changes.

At issue is whether the proposed health service or treatment of an intraosseous basivertebral nerve ablation is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

The health plan's determination is upheld, in whole.

The proposed health service or treatment of an intraosseous basivertebral nerve ablation is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. The patient has complaints of low back pain.

There is a request for intraosseous basivertebral nerve ablation. This procedure is not recommended. Despite promising early reports, further trials with longer-term outcomes and less risk of bias are required. An Food and Drug Administration (FDA) investigational device exemption trial examined 225 chronic low back pain patients with type I or II Modic changes who were randomized to the requested procedure or sham treatment, resulting in decreased Oswestry Disability Index (ODI) of 20.5 and 15.2 points, respectively. The authors noted that these marginally clinically meaningful improvements suggested some potential as a minimally invasive treatment, however, there is lack of data to recommend this procedure as treatment modality. In general, there is lack of substantial support for this procedure, and it is currently not considered standard of care.

Given the above, the proposed health service or treatment of an intraosseous basivertebral nerve ablation is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Back pain
Treatment: Intraosseous basivertebral nerve ablation
The health plan denied: Intraosseous basivertebral nerve ablation
The determination is: Overturned

The patient is a female who has chronic low back pain. Her pain is constant shooting across her low back with increased symptoms from flexion. She has tried physical therapy (PT), lumbar spinal injection, and pain medications without adequate pain relief. Her pain level is 8/10 with negative impact on her activities of daily living (ADL) and quality of life (QOL). The physical exam revealed decreased lumbar spine range of motion (ROM) and negative straight leg raise (SLR). The lumbar spine magnetic resonance imaging (MRI) revealed Modic changes at lumbar 5 (L5) and sacral 1 (S1) with mild disc bulge.

At issue is whether Intraosseous basivertebral nerve (BVN) ablation is likely to be more beneficial than any standard treatment or treatments. The health plan's determination regarding the proposed health service or treatment is overturned in whole.

The proposed health service or treatment of intraosseous basivertebral nerve ablation is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

The Intraosseous nerve ablation procedure (INTRACEPT) is designed to treat low back pain from vertebral body by ablating intraosseous nerves. There are multiple clinical trials demonstrating the sustained improvements in pain and function of this intervention for patients with vertebrogenic pain. This patient's persistent low back pain is consistent with vertebrogenic pain. She had tried conservative treatments without success. Her pain level is 8/10 with limitation on her ADLs and QOL. Further interventions are medically necessary to improve her pain and function. Other potential treatment options are long-term use of medications (opioids) and lumbar decompression fusion surgery. However, none of these options has a high success rate, and all of them carry significant risks and complications. Given this clinical scenario, intraosseous basivertebral nerve ablation should be the next step intervention.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Back pain
Treatment: Intraosseous basivertebral nerve ablation
The health plan denied: Intraosseous basivertebral nerve ablation
The determination is: Overturned

The patient is a female with a history of chronic low back pain. Magnetic resonance imaging (MRI) of the lumbar spine revealed Modic changes from lumbar 3 (L3) to sacral 1 (S1). She has been treated with epidural steroid injections and lumbar facet joint ablation. She has also been treated with gabapentin, ibuprofen, muscle relaxers, and Tylenol. She has continued difficulty with activities of daily living and reduced quality of life.

At issue is whether Intraosseous basivertebral nerve (BVN) ablation is likely to be more beneficial than any standard treatment or treatments. The health plan's determination regarding the proposed health service or treatment is overturned in whole.

The proposed health service or treatment Intraosseous basivertebral nerve ablation would be likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

Intracept is a minimally invasive procedure that targets the basivertebral nerve for the relief of chronic vertebrogenic low back pain. A review of available up-to-date publications utilizing BVN ablation in the treatment of vertebral pain suggests that there is quality evidence that this is an effective intervention for reduction of disability and improvement in function, at short- and long-term follow-up, in addition to evidence that BVN radiofrequency ablation (RFA) is superior to conservative care for pain reduction, at least at 3-month follow-up. Also, there is a highly clinical and statistically significant treatment effect of BVN ablation for vertebral pain with clinically meaningful benefits in pain reduction, functional improvements, opioid dose reduction, and improved quality of life. There were no reported device-related patient deaths or serious adverse events based on the available literature. BVN ablation is a safe, well-tolerated, and clinically beneficial intervention for vertebral pain, when proper patient selection and surgical/procedural techniques are applied.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Autistic spectrum disorder (ASD).
Treatment:  35 hours per week of consumer directed personal assistance services (CDPAS).

The insurer denied coverage for 35 hours per week of consumer directed personal assistance services (CDPAS).  The denial is upheld.
 
This is a young child with Autistic spectrum disorder (ASD) and who lives with parents. The patient has strong family support. Hearing tests, vaccines, and dental checks are all up-to-date. In-home personal care is requested.

The health care plan acted reasonably and with sound medical judgment and in the best interest of the patient. The patient has autistic spectrum disorder (ASD) and lives with parents. The member has strong family support. It was noted 17.5 hours of consumer directed personal assistance services (CDPAS) was approved for this patient. Medical records did not support the need for additional care due to worsening of an existing illnesses or new medical issues.      

Based on the medical data reviewed, the number of hours previously approved (17.5) appears sufficient to meet the participant's mobility and activities of daily living (ADL's) needs. There is a lack of significant objective deficit, sufficient to warrant an increase in home healthcare services at this time.  As such, this request is not medically necessary.

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 35 hours per week of consumer directed personal assistance services (CDPAS) is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Hypertension, stroke with hemiplegia and has a percutaneous endoscopic gastrostomy (PEG) tube. 
Treatment: Personal care aide (PCA): 12 hours per day - 7 days per week; 12 hours per day - 7 days per week (split shift) - a total of 168 hours per week. 

The insurer denied coverage for personal care aide (PCA): 12 hours per day - 7 days per week; 12 hours per day - 7 days per week (split shift) - a total of 168 hours per week. 

The denial is overturned. 

This is an elderly female with multiple medical problems that include hypertension, stroke with hemiplegia and has a percutaneous endoscopic gastrostomy (PEG) tube. She also requires portable oxygen via nasal cannula or mask. The patient lives with her partner in a 2-bedroom apartment. The insurer approved a PCA; live in per diem - 7 days per week. The request is for PCA 12 hours per day - 7 days per week; 12 hours per day - 7 days per week (split shift) - a total of 168 hours per week.

According to the Uniform Assessment System (UAS) report, the patient's cognition is described as severely impaired. She is totally dependent for performing Instrumental Activities of Daily Living (IADL) tasks including meal preparation, ordinary housework and shopping. She is also totally dependent for activities of daily living (ADL) tasks including bathing, personal hygiene, dressing, eating, bed mobility, locomotion, toilet transfer/use and is non-ambulatory. The patient is also incontinent of bowel and bladder. 

The clinical records including personal care logs, hospital discharge summary and nursing facility notes clearly demonstrate the patient's clinical condition and functional deficits are at a level and unpredictable as to require the requested personal care service (PCS) 7 days per week, 24 hours per day split shift. Of particular concern are her limited mobility, limb rigidity and extremely high risk for pressure ulcers. She requires routine repositioning in bed at least every 2-3 hours, and portable oxygen via mask/nasal cannula. Based on the clinical records, a live-in PCA is unlikely capable of obtaining approximately 5 hours of uninterrupted sleep over the course of a 24 hour shift. This physician would agree that attention to the patient's functional needs are more appropriately provided and maintained by the requested PCS 12 hours per day- 7 days per week (split shift) for a total of 168 hours per 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): 12 hours per day - 7 days per week; 12 hours per day - 7 days per week (split shift) - a total of 168 hours per week is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Malocclusion
Treatment: Braces and monthly visits
The insurer denied coverage for braces and monthly visits.
The denial is overturned.

Upon review of the submitted documentation including lateral cephalometric radiograph, panoramic radiograph, montage of extraoral and intraoral clinical images, dental treatment noted as well as insurer correspondence, it appears that this patient presented for evaluation for orthodontic care. The orthodontist identified overjet, overbite, ectopic eruption, Class II canines, anterior crossbite, and anterior maxillary and mandibular crowding. The orthodontist has completed the Handicapping Labio-Lingual Deviation (HLD) index, attaining 30 total points. The insurer has denied coverage for orthodontic treatment as not medically necessary, as the clinical circumstance does not meet the required handicapping malocclusion medical necessity requirements, attaining only 22 points on the HLD index by internal reviewers.

Upon review of the submitted documentation (study models were not provided for review), it is evident that the patient exhibits a significant malocclusion. However, to assess for severity of the malocclusion and therefore medical/dental necessity for orthodontic care, New York State requires, as of September 1, 2012, the use of an orthodontic Index, the HLD index report (HLD, New York State Medicaid program) modeled after HLD index. This index provides six specific conditions that automatically qualify for orthodontic care. Additional criteria are used, utilizing a point system if none of these initial qualifying conditions are met or selected. For these other secondary criteria to qualify for orthodontic care, a total score of 26 points is necessary. 

In this case, the treating orthodontist completes the second portion of the index arriving at 30 points to justify orthodontic care. This reviewer concurs with the index completed by the orthodontist, which remains above the threshold of 26 points to support orthodontic care. 

Regarding the validity of the HLD index, it has been shown through scientific scrutiny in peer reviewed journals that this methodology for assessing orthodontic need is a valid approach. Each of these peer reviewed articles concludes that this index is a valid and reliable determinant of need for orthodontic care. As this is an accepted methodology, this has been determined to represent an appropriate approach for assessing orthodontic need.

Reverse denial as the clinical circumstance as presented does meet and substantiate the medical/dental necessity of orthodontic care as it meets the accepted criteria for approval.

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

The medical necessity for braces and monthly visits is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Status asthmaticus. 
Treatment: Inpatient admission. 

The insurer denied coverage for Inpatient admission. 

The denial is overturned. 

This is a male child with a history of virus induced wheezing who has been treated in the past with albuterol when wheezing. There was a history of asthma in the family. He was sick for 2 days with a runny nose and a cough with wheezing. He had a fever of 103 degrees Fahrenheit at home. On the day prior to admission he developed increased work of breathing with subcostal retractions which did not improve when the mother administered 2 albuterol treatments in the home.  When the wheezing and increased work of breathing did not improve the mother brought him to the emergency room (ER) for additional treatment. 

In the ER he was noted to have increased work of breathing with tachypnea to 56 breaths per minute, wheezing and retractions. He was treated with 3 doses of combivent, dexamethasone, intravenous (IV) magnesium and an IV bolus of normal saline, duoneb on three occasions, and magnesium sulfate. A test for Respiratory Syncytial Virus (RSV) virus was negative. When his wheezing and increased work of breathing did not improve with treatment in the ER the decision was made to admit the child to the hospital with a diagnosis of status asthmaticus for continued treatment with albuterol every 2 hours. 

The patient was treated appropriately in the ER for an acute episode of wheezing and difficulty breathing. The child has a history of asthma with multiple treatments with albuterol when sick with a virus. When he did not respond to treatment in the ER with frequent albuterol, dexamethasone and intravenous (IV) magnesium and his work of breathing and subcostal retractions persisted the decision was made to admit him to the hospital with a diagnosis of status asthmaticus. He was not stable enough to be safely discharged since he required albuterol every 2 hours. 

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 the inpatient admission is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Alopecia universalis.
Treatment:  Xeljanz 5 MG (milligram) OR (oral) TABS (tablets).

The insurer denied coverage for Xeljanz 5MG OR TABS.  The denial is overturned.
 
This patient is a child with a diagnosis of alopecia universalis. The patient has failed therapy with multiple medications, including topical tofacitinib, topical steroids, Intralesional Kenalog, and oral minoxidil. She has failed systemic therapy with a minoxidil tablet. The request is for oral Xeljanz therapy.

Based on the provided documentation the patient requires systemic therapy and has exhausted reasonable available options. Xeljanz has been shown to decrease the inflammation leading to hair loss and has been shown safe and effective in the pediatric population based on case reports. The patient has failed oral minoxidil and has limited therapeutic options given her age and risk of potential side effects. The denial is overturned, and the use of Xeljanz is medically necessary for use in the treatment of the patient's condition.

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 Xeljanz 5MG OR TABS is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Umbilical hernia 

Treatment: Inpatient admission

The insurer denied coverage for an inpatient admission

The denial is upheld

 
Umbilical hernias are common surgical complaints. These hernias can become symptomatic and therefore are at an increased risk of incarceration and subsequent strangulation. Therefore, surgical repair is indicated. Emergency repair has been associated with an increased risk of mortality, reoperation, and readmission. Bowel compromise can occur regardless of the hernia size, and the belief that larger hernias do not incarcerate is inaccurate.

Per clinical documentation, the patient presented to the emergency department with abdominal swelling and skin changes at the umbilicus. Vital signs were significant for a blood pressure of 99/41 and a pulse rate of 45. White blood cell count was 3.3. A computed tomography (CT) scan that was performed indicated a fluid-filled umbilical hernia. The patient underwent an umbilical hernia repair with mesh. There were no reported complications postoperatively. On postoperative day 0, the foley catheter was removed but the patient was unable to void. The catheter was reinserted and removed again with normal voiding. The hepatology service was consulted and there were no contraindications to discharge. The patient was discharged home. Peer-reviewed literature indicates that the greatest variable associated with hospital admission is totally dependent baseline functional status. The patient was not noted to have any functional impairments. Therefore, the requested hospital stay should be observation status. 

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 a full hospital admission is not substantiated.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Stage IV sacral pressure ulceration. 
Treatment: Grafix prime tissue engineered skin substitute. 

The insurer denied coverage for Grafix prime tissue engineered skin substitute. 

The denial is overturned. 

This is a patient with a stage four (IV) sacral pressure ulcer. The patient is receiving home nursing care for wound care. The patient has tried Wound Vac, honey, collagen, foam dressings, Dakin's, etc. Wound measurements and photos were enclosed. The request is for Grafix prime tissue engineered skin substitute, which is under review. 

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

Grafix is a cryopreserved placental membrane in which the structural and cellular integrity of fresh placental membranes is preserved (DaVanzo et al). 

For treatment of chronic, non-infected, full-thickness diabetic foot ulcers (DFUs), Grafix has been shown in two clinical trials to be beneficial (Lavery et al). 

There are also multiple studies published on the use of Grafix with complex wounds (Johnson et al, Farivar et al). 

Therefore, the scientific evidence in the peer-reviewed literature supports a result of improvement in health outcomes. 

Grafix prime tissue engineered skin substitute has final approval from the appropriate regulatory bodies for this diagnosis. 

Grafix is regulated by the Food and Drug Administration (FDA) under 21 CFR Part 1271 Part 361 Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps). 

This patient has a documented pressure ulcer that failed prior standard wound care treatment as shown by serial wound care measurements. The size of the ulcer is significant enough for the use of the requested advanced wound care product. There is a compelling reason for the use of an advanced wound care product in this patient. Therefore, this patient is a good candidate for Grafix prime tissue engineered skin substitute. 

 Grafix is one of many tissue engineered skin substitutes available and there is not one best or superior product, however, is an appropriate option for this patient for an advanced wound care product. 

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

There are minimal excess risks of this product as compared to other standard wound treatment/services. 

Wound Healing Outcomes - All included studies reported on the proportion of completely healed ulcers: three publications presented results from week 6, 23,25,27 and three from week 12, 24,26,28 (Figure 2). In all studies, statistically significant improvements were observed in the intervention group". (Luck, J., et al., 2019). 

In summary, the denial of Grafix prime tissue engineered skin substitute 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 risks are not substantially increased over standard treatments.