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

Diagnosis:  Hypertesnsion; chronic venous stasis ulcers; gait ataxia
Issue under review:  Additional CDPAP Service hours

Determination:  The Additional CDPAP Service hours are medically necessary.

This is an elderly female with a history of malignant hypertension, thrombophlebitis, chronic venous stasis ulcers and gait ataxia.  For these reasons, she requires assistance with completion of the majority of her activities of daily living (ADLs).  Recent documentation from the patient's Primary Care Physician indicates that due to worsening gait ataxia and overall functional decline, the currently approved plan is insufficient to meet the patient's needs.  For these reasons, the proposed treatment of an increase in Consumer Direct Personal Assistance Program services is deemed medically necessary for increased ADL assistance.
Appeal type: Medical necessity
Decision: Upheld

Genitourinary/Kidney Disorder
Pharmacy/Prescription Drugs

The patient is a male with long standing dense deposit disease with complement cascade involvement. This is a rare disease with high rates of end stage renal disease. The patient was able to achieve remission with eculizumab, but failed termination of therapy with progressive proteinuria and renal insufficiency. He was restarted on eculizumab, a monoclonal antibody against complement factor C5, but has difficulty maintaining his employment and travel to his prescribing medical center with the frequency of his current infusions. The medical team seeks to convert therapy to ravulizumab in an effort to reduce burden on the patient.
Currently eculizumab has adult indications for paroxysmal nocturnal enuresis, hemolytic uremic syndrome (HUS), and limited use in myasthenia gravis and neuromyelitis optica spectrum disorder. Ravulizumab is a pH-switched version of eculizumab with improved pharmacokinetic and pharmacodynamic characteristics compared to eculizumab.
The subject under review is the medical necessity for the requested ravulizumab.

The health plans determination  is upheld.

The patient has an effective therapy use through eculizumab and it does not appear that there is a medical necessity in changing therapy. Although ravulizumab shows promise in improving quality of life through less frequent infusions than eculizumab, the evidence at this time for supporting conversion is limited. At the time of writing commentary for this review, there is no published literature in PubMed on the use of ravulizumab outside of paroxysmal nocturnal hemoglobinuria.
Ravulizumab was recently Food and Drug Administration (FDA) approved for use in atypical hemolytic uremic syndrome, but the supporting clinical trials have not been published to PubMed to date. The likelihood that studies will be completed in dense deposit disease anytime soon are quite low considering that success of eculizumab in treating dense deposit disease has been mixed, dense deposit disease is a rare disease, and eculizumab is not an FDA approved treatment for dense deposit disease.
Appeal type: Medical necessity
Decision: Upheld

Cancer
Radiation Therapy

This patient is a woman with a right base of tongue adenoidcystic carcinoma post debulking with tracheostomy and percutaneous endoscopic gastrostomy (PEG) placement. Radiation therapy with concurrent chemotherapy are recommended to attempt long term control and organ preservation. The proton beam approach is requested and is under review.

The health plan's determination is upheld. The proposed proton beam radiation therapy for this patient is not considered medically appropriate nor necessary and is not a standard treatment option recognized in the oncologic medical community. There is a lack of any significant data published in peer reviewed medical literature supporting the efficacy and safety of proton beam radiation for adenoidcystic head and neck malignancies. There are multiple studies published that are single institution non randomized trials stating the need for addition trials to determine the efficacy and safety of proton beam radiation therapy as compared to photon beam radiation intensity modulated radiation therapy (IMRT). Therefore, the proton beam treatment is not indicated in this case.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Aberrant origin of the right subclavian artery

Treatment:  Inpatient admission

The insurer denied the inpatient admission.  The denial was upheld.   

This is a female patient who presented to the Emergency Department with complaints of headache rating it 5/10 in severity, dizziness, and left arm pain.  She was alert and oriented to person, place, and time.  Her presenting blood pressure was 123/82.  It was reported that the patient was a recent new mother.  She took oral contraceptives daily.  She was consulted by Neurology.  A chest x-ray was performed that revealed no active pulmonary disease.  A magnetic resonance imaging (MRI) of the brain and a magnetic resonance angiogram (MRA) of the neck were performed.  There was no intracranial pathology noted on the MRI of the brain; it was negative for acute stroke or hemorrhage.  The MRA of the neck revealed aberrant origin of the right subclavian artery.  The patient was medically stabilized and discharged home.

The patient presented with headache, dizziness, and left-arm weakness.  The MRI of the brain was negative for acute stroke or hemorrhage.  The patient could have been evaluated in the Emergency Department with an MRI being performed along with appropriate specialty consultation.  The care provided did not warrant an inpatient admission.

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

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

Diagnosis: Shortness of breath
Treatment: Inpatient admission
The Inpatient admission was medically necessary.

The patient is a male. He has a past medical history significant for asthma, diabetes mellitus type 2, HTN (hypertension), chronic kidney disease (Stage 5). He presented to the hospital for complaints of dyspnea, associated with leg edema, wheezing, after a recent nuclear stress test had demonstrated severe cardiomyopathy with EF (ejection fraction) of 35%. 

The patient was hemodynamically stable, but had tachypnea. On examination, he was noted to be in respiratory distress. The ECG (electrocardiogram) revealed sinus rhythm with left bundle branch block. The chest X-ray revealed pulmonary vascular congestion and cardiomegaly. Serum creatinine was elevated at 4.4, BUN (blood urea nitrogen) 56. pBNP (NT-Pro B-Type Natriuretic Peptide) was severely elevated at 4,127. 

The patient was admitted for management of new onset decompensated CHF (congestive heart failure). Cardiology and nephrology consultations were obtained. Echocardiogram revealed reduced LV (left ventricle) function. Patient was treated with IV Lasix, IV steroids and therapy for CHF. Cardiac catheterization was scheduled with a plan for post-catheterization hemodialysis. 

Catheterization revealed non-ischemic dilated cardiomyopathy, secondary pulmonary hypertension. The patient underwent dialysis, and once his renal function was stable, was discharged home with a plan for outpatient follow-up.

The patient presented with symptoms of acute CHF exacerbation, with newly diagnosed severe systolic dysfunction. ECG was abnormal with left bundle branch block (LBBB). BNP was elevated. Chest X-ray was consistent with CHF. Stress test and echocardiogram were abnormal. The course was complicated due to his severe renal disease, as well as need for coronary angiography and associated risk of contrast induced nephropathy. In fact, the patient required an inpatient hemodialysis session, following his cardiac catheterization. This patient with multiple co-morbidities, who presented with CHF exacerbation, was appropriately treated with IV diuresis. He required close monitoring of his CHF and renal function, given the underlying kidney disease. Given this presentation, acute CHF, as well as multiple risk factors, co-morbid conditions and suspected CAD with need for cardiac catheterization to determine the etiology of his cardiomyopathy, it would be consistent with the current standard of care that this patient be managed in an inpatient setting. Therefore, the requested inpatient admission was medically necessary in this clinical setting.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: DM, Anemia, HTN, CKD
Treatment: Consumer directed personal care assistance services five hours/day, seven days/week, for a total of 35 hours/week

The proposed treatment of an increase in Consumer directed personal care assistance services to five hours/day, seven days/week, for a total of 35 hours/week is deemed medically necessary. 

This is a male with a history of Type II Diabetes Mellitus, Anemia, Hypertension and Chronic Kidney Disease. Due to impairments related to these conditions, he requires assistance with the majority of his activities of daily living (ADLs). Recent documentation from the patient's Primary Care Provider indicates that due to worsening fatigue with minimal exertion and dizziness resulting in significant gait ataxia, the patient has been demonstrating progressively worsening functional decline. For these reasons, the currently approved plan of 24 hours/week consumer directed personal care assistance services is insufficient to meet the patient's current needs. Hence, the proposed treatment of an increase in Consumer directed personal care assistance services to five hours/day, seven days/week, for a total of 35 hours/week is deemed medically necessary for increased assistance with completion of the patient's ADLs.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Severe Spinal Stenosis

Treatment:  Oxycodone 5 mg tablet (1-2 tablets every 6 hours as needed for a total of 180 tablets)

The insurer denied Oxycodone 5 mg tablet (1-2 tablets every 6 hours as needed for a total of 180 tablets).  The denial was reversed.   

This is a female patient who suffers from severe spinal stenosis and has a history of sciatica, obstructive sleep apnea, depression, carotid artery stenosis, hypertension, chronic obstructive pulmonary disease, hypercholesterolemia, osteoarthritis, tendonitis, fibromyositis, alcohol abuse, status post cervical spine surgery, status post laminectomy, status post foot drop surgery, and status post C3-4 anterior cervical discectomy and fusion.  It was reported that the patient suffers from chronic pain and had been on a stable dose of a narcotic for the past several years.  She has had serial urine drug testing, all of which have been normal.  A request was made for continued medication to manage his pain.    

Dowell et al.(1) have commented on the misapplication of the CDC guideline, which has led to decisions like this one by the Health Plan (HP).  "Unfortunately, some policies and practices purportedly derived from the guideline have in fact been inconsistent with and often go beyond, its recommendations.  A consensus panel has highlighted these inconsistencies, five which include inflexible application of recommended dosage and duration thresholds and policies that encourage hard limits and abrupt tapering of drug dosages, resulting in sudden opioid discontinuation or dismissal of patients from a physician's practice . . . patients may find tapering challenging; could face risks related to withdrawal symptoms, increased pain, or unrecognized opioid use disorder; and if their dosages are abruptly tapered may seek other sources of opioids or have adverse psychological and physical outcomes.  Policies should allow clinicians to account for each patient's unique circumstances in making clinical decisions."

Kroenke et al.(2) similarly, have supported the continuation of opiates at lower levels in patients who are stable, functional and show no signs of abuse.  

The insurer did not act reasonably, or with sound medical judgment, or in the patient's best interest.

The carrier's denial of coverage for Oxycodone 5 mg tablet (1-2 tablets every 6 hours as needed for a total of 180 tablets) is reversed.  The medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Cyclic vomiting syndrome

Treatment: Inpatient Admission 

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

This is a male patient with a history of cyclic vomiting syndrome and daily marijuana usage. He presented to the Emergency Department (ED) with complaints of vomiting and abdominal pain. His presenting blood pressure was 150/100, and heart rate of 104. Despite receiving Zofran Reglan, and Haldol in the ED he continued to have vomiting episodes. Laboratory work up was performed that revealed a white blood cell count of 11. He received intravenous (IV) fluids and was maintained on a clear liquid diet. The patient's symptoms improved and he was deemed medically stable for discharge. The patient left against medical advice (AMA) before being discharged. 

According to guideline, the patient may be admitted for abdominal pain when there is the need for surgical intervention that cannot be performed on an ambulatory basis, peritoneal signs severe pain requiring inpatient management, or has hemodynamic instability, bacteremia or signs of intestinal obstruction.  Based on the review of this patient's medical record, these clinical criteria were not present to support inpatient admission. Based on the literature review, the care that the patient received as inpatient could have been appropriately provided at an observation setting. The patient was young and was hemodynamically stable, with no other comorbidities that put the patient at risk for acute inpatient care. The patient's cyclic vomiting syndrome was previously established with his marijuana use, and was a relatively benign disorder.

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

Based on the above, the medical necessity for the inpatient hospital services at the acute level of care is not substantiated.  The insurer's denial is upheld.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Malocclusion

Treatment:  Comprehensive Orthodontic Treatment and Periodic Orthodontic Treatment

The insurer denied the Comprehensive Orthodontic Treatment and Periodic Orthodontic Treatment.  The denial was reversed.   

This is a patient that was evaluated for orthodontic treatment.  Her evaluation included lateral cephalometric radiograph, panoramic radiograph, montage of extraoral and intraoral clinical images with diagnostic results of Skeletal Class III, Hypoplastic Maxilla, maxillary and Mandibular crowding, and Anterior Crossbite with Gingival Attachment Loss.  Recommendation was made for orthodontic treatment. 

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, a Handicapping Labiolingual Deviation Index is utilized.  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 claims an automatic qualifying condition of crossbite of individual anterior teeth when clinical attachment loss and recession of the gingival margin are present.  This reviewer finds that this automatically qualifying condition criterion is met and does support comprehensive orthodontic care.  In this case, the clinical circumstance does meet insurer and plan criteria to justify orthodontic care.

Regarding the validity of the Handicapping Labiolingual 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 the 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.   

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

Based on the above, the medical necessity for comprehensive orthodontic treatment and periodic orthodontic treatment is substantiated.  The insurer's denial is reversed.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Orthopedic /Musculoskeletal - Other
Treatment:  Radiology Services

The patient is a female with a symptomatic pelvic bony tumor at the right acetabular wall.  The lesion involved this region only and was small.  The patient had a history of failure of conservative medical treatment with medication.  Aspirin and ibuprofen were used.  She had right hip pain at presentation for 18 months without injury or trauma.  Her past medical history was unremarkable.  Pertinent past medical records were reviewed.  Lab work unremarkable.  She had stopped strenuous activities.  Imaging confirmed the lesion; both by magnetic resonance imaging (MRI) and by computed tomography (CT).  This was an osteoid osteoma for which she underwent an ablation procedure under image guidance with general anesthesia support.  The treatment plan was completed.

The health plan's determination is overturned.

The patient had an osteoid osteoma that required treatment with ablation.  It should be treated with image guided percutaneous ablation.  Open surgical procedures are not indicated.  Conservative measures were attempted without success.  It was treated successfully, and the patient did well, and is currently asymptomatic after an image guided ablation procedure.
The standard of care for treatment of osteoid osteoma is ablation.  This assumes conservative measures have not been helpful or efficacious, including oral analgesic medications.  Surgical resection is rarely performed.  This patient definitely needed and benefited from ablation.
The most common literature confirming this standard is related to heat based ablation performance.  This is mainly RFA or radiofrequency ablation.  However, most medical centers rarely do RFA anymore, as most centers performing heat based ablation use Microwave now.  It is more precise, more repeatable and simpler to use.
The ability to keep up to date on technology and to use the best performing devices should be paramount in decisions by the medical team.  This is especially true when deciding on device choice for ablation for osteoid osteoma in a child.  
Cryoablation, which is also known as cryosurgical ablation, is an alternative to heat based ablation that is a reasonable and good choice for osteoid osteoma treatment.  The cryo procedure does not require any dispersion pads, and there is no risk of skin burn.  It can be done with image guidance similar to any ablation.  The length of time for the procedure is similar, and there is a lower expected morbidity.
The cryo procedure for osteoid osteoma for this patient was medically necessary and consistent with the standard of care.
Appeal type: Formulary Exception
Decision: Overturned

Hepatitis
Pharmacy/Prescription Drugs

The patient is a male with a history of human immunodeficiency virus (HIV) infection, on treatment with Genvoya, as well as Hepatitis C, who was offered outpatient treatment of his Hepatitis C with Mavyret. Although Harvoni and Epclusa are listed as preferred agents for treatment of Hepatitis C under the plan, the available documentation indicates that Mavyret was selected specifically because the preferred agents have significant drug-drug interactions with his Genvoya.

The health plan's determination is overturned. The sofosbuvir component of Epclusa and Harvoni interacts with the tenofovir component of Genvoya, moderately increasing serum levels of tenofovir. Higher serum levels of tenofovir, in turn, increase the risk of known adverse effects of this drug, including renal failure, lactic acidosis and hepatic toxicity (Vemlidy prescribing information). While there is technically also an interaction between the cobicistat component of Genvoya and both glecaprevir and pibrentasvir (the components of Mavyret), the degree of this interaction is comparatively minor. The patient risks of these interactions are also significantly lower, as fewer serious adverse events have been reported with Mavyret than with tenofovir-containing treatment regimens. The greatest risk is hepatic failure, but this is rarely reported and may actually be a manifestation of patients' underlying liver disease, rather than a direct effect of Mavyret (Mavyret prescribing information). It would not be appropriate to change antiretroviral therapy to avoid the interaction, as this introduces additional risks of adverse drug events and potential loss of HIV suppression. Thus, the non-formulary Mavyret is a more appropriate option for Hepatitis C treatment in this patient.
Appeal type: Experimental/Investigational
Decision: Overturned

Reviewer #2:  

This is a male patient with a history of cervicalgia and cervicogenic headaches. He is seeking the treatment of incision for implantation of neurostimulator electrodes; peripheral nerve; excludes sacral nerve and fluoroscopic guidance and localization of needle or catheter tip for spine or paraspinous diagnostic or therapeutic injection procedures.  

There is no literature with randomized controlled trials to suggest improvement in health outcomes.  There are no large long term studies showing efficacy and benefit of occipital stimulation for treating occipital neuralgia.  More studies are needed.  Hayek, noted a level 3 study showing "Based on the data derived from this systematic literature review, the following Level III recommendation can be made: the use of ONS is a treatment option for patients with medically refractory ON.  "Therefore long term randomized studies are needed that are stronger than level 3 evidence to suggest this as treatment option."  

Procedure codes 64575 (incision for implantation of neurostimulator electrodes; peripheral nerve; excludes sacral nerve) and 77003 (fluoroscopic guidance and localization of needle or catheter tip for spine or paraspinous diagnostic or therapeutic injection procedures) are not the best available treatment for this patient at this time.  As noted above given the lack of large long term studies showing benefit.  

The carrier's denial of procedure codes 64575 (incision for implantation of neurostimulator electrodes; peripheral nerve; excludes sacral nerve) and 77003 (fluoroscopic guidance and localization of needle or catheter tip for spine or paraspinous diagnostic or therapeutic injection procedures) should be upheld.