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

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

The insurer denied Positron Emission Tomography and Computed Tomography (PET CT). 
The health plan's determination is overturned. 

The patient is a male with metastatic prostate cancer. He has received androgen deprivation therapy as well as chemotherapy. Recent imaging has noted resolution of many bony metastatic sites; however, the recent results of standard imaging are ambiguous and require additional testing to assess the treatment response. This information would be used to guide further therapy. 

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

The requested health service and treatment of Positron Emission Tomography and Computed Tomography (PET CT) is medically necessary for this patient. The patient has several areas identified on conventional imaging which require further clarification. The National Comprehensive Cancer Network (NCCN) guidelines endorse the use of this radiologic testing in this clinical situation. Literature notes, "Background PET CT imaging with the radiopharmaceutical molecular imaging and contrast agent [11C]-Choline has become a useful tool in the detection of prostate cancer, mainly used in the assessment of treated patients presenting rising prostate-specific antigen (PSA) and negative response after conventional imaging procedures."
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Benign Prostatic Hyperplasia
Treatment: Prostate Aquablation (code 042IT)
The insurer denied: Prostate Aquablation (code 042IT)
The denial is upheld

The patient is an adult male with a diagnosis of benign prostatic hyperplasia with urinary obstruction. Detailed medical information including associated symptoms, prior therapy and 
prostate anatomy information is unknown. Medical appropriateness for Aquablation of the prostate is under review.

The health plan should not cover the proposed treatment. 
Aquablation is a novel procedure for management of benign prostatic hyperplasia. The Aquablation procedure uses a targeted high velocity saline stream to ablate prostatic tissue 
without generation of thermal energy under real-time ultrasound guidance. Current medical literature is limited with a few studies with limited long-term outcomes. As such use of aquablation is not considered a clinically appropriate and generally acceptable standard of care for managing patients with benign prostatic hyperplasia. Hence, it would be considered experimental and not medically appropriate. American Urological Association guidelines on benign prostatic hyperplasia, 2019 states "Aquablation may be offered to patients with lower urinary tract symptoms (LUTS) attributed to BPH (benign prostatic hyperplasia) provided prostate volume is more than 30 g (grams) and less than 80 g, however, patient should be informed in long-term evidence of efficacy and retreatment rates, remain limited."

European Association of Urology guidelines on management of nonneurogenic male urinary tract symptoms, 2019 states "The first clinical experience provides encouraging results, with a low risk of sexual dysfunction, but further modifications of the aqua beam cystoscopy may be necessary. Long-term follow-up will help us assess the clinical value of Aquablation."

In addition, detailed medical information regarding prior therapy, prostate volume and associated symptoms is largely unknown. As such the requested procedure would not be considered clinically appropriate and generally excepted standard for management of this patient's medical condition. Hence it would be considered experimental/investigational.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Benign Prostatic Hyperplasia
Treatment: Prostate Aquablation (code 042IT)
The insurer denied: Prostate Aquablation (code 042IT)
The denial is upheld

This adult male with Benign Prostatic Hyperplasia has requested coverage for treatment with the "Aqua Beam" Transuretheral Waterjet Ablation" of the prostate. Bladder stones were also removed with Holmium laser lithotripsy. The procedure was denied as experimental/investigational.

The health plan should not cover the proposed treatment. 

The Plan's denial was based on the following--"To date we have not received any information that aquablation is required for the treatment or management of your benign prostatic hyperplasia with lower urinary tract symptoms (benign prostatic hyperplasia BPH) is a noncancerous enlargement of the prostate gland), or that if you do not receive this aquablation your prostate enlargement could get worse, and we are unable to establish that the service requested is medically necessary." 

As noted by the Plan, information regarding prostate volume, prior medical therapies were not provided. There was insufficient documentation to determine the medical appropriateness of the procedure.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Benign Prostatic Hyperplasia
Treatment: Prostate Aquablation (code 042IT)
The insurer denied: Prostate Aquablation (code 042IT)
The denial is upheld

The patient is an adult male who underwent aquablation of prostate for BPH (benign prostatic hyperplasia) and bladder stones. There were no office notes provided and limited operative report provided. During formal appeal, the procedure was denied as experimental/investigational. 

The health plan should not cover the proposed treatment. 

The documentation provided does not support that the patient's in need for minimally invasive treatment for benign prostatic hyperplasia - specifically there is lack of documentation of persistent or progressive, moderate to severe lower urinary tract symptoms despite medical therapy, that the patient has a prostate volume that is 30-80 cubic centimeters (prostate volume) and that the patient is a poor candidate for other surgical therapies for benign prostatic hyperplasia due to underlying disease.  The AUA (American Urology Association) guidelines on benign prostatic hyperplasia notes "water vapor thermal therapy should be considered as an option provided the volume is 30-80cc" The level of evidence is a C, and the guidelines notes three years data supporting maintenance of efficacy.

There is lack of long-term follow up to know the long-term results of prostate aquablation. A comparative study between TURP (transurethral resection of the prostate) and water vaporization demonstrated comparable results at one year with lower side effects, however long-term follow up has not been established and thus it is not possible to determine if this treatment is more beneficial than any standard treatment for the insured's condition or disease. Furthermore, there is lack of documentation to support that the patient fits recommended criteria for the procedure.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Pulmonary Embolism
Treatment: Eliquis
The insurer denied: Eliquis
The denial is: Upheld

The patient is a female with a history of pulmonary embolism. The patient is stated to be intolerant of Xarelto due to severe numbness and pain in her hands and feet. Eliquis has been recommended and is under review.

The health plan's determination is upheld.

Neither Xarelto nor warfarin have been demonstrated to be inferior to Eliquis. The included documentation does not indicate that this patient is intolerant of warfarin, one of the formulary alternatives, nor that she has failed it; similarly, there is a paucity of documentation indicating this patient has a contraindication to the formulary alternatives. Neither the authors of UpToDate nor the peer-reviewed literature recommend one of these agents as being superior to another and thus given their relative equivalency, the formulary options are reasonable and would not have adverse effects that the non-formulary alternative would. If the patient is intolerant of Xarelto, warfarin is a reasonable and medically acceptable alternative.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Altered Mental Status
Treatment: Inpatient Stay
The insurer denied: Inpatient Stay
The denial is: Overturned

The patient is a female who was admitted to the hospital for pneumonia. The patient presented to the emergency department with altered mental status; she reportedly had slurred speech and a syncopal episode. In the emergency department she continued to have garbled speech. Vitals and initial labs were normal. Chest x-ray showed patchy bilateral airspace opacities. Computed tomography (CT) of the head was normal. She was admitted for pneumonia and altered mental status of unknown etiology.
The patient received antibiotics for her pneumonia. She had an MRI of the brain with no acute pathology. Consultation was obtained from both neurology and psychiatry. Psychiatry felt that her symptoms were due to acute delirium which was due to the illness and tetrahydrocannabinol (THC) use. She improved symptomatically and was discharged home in good condition. The subject under review is the medical necessity for the inpatient stay.

The health plan's determination is overturned.

The requested inpatient stay was medically necessary for this patient.
The patient does not meet inpatient criteria for treatment of her respiratory symptoms alone. However, she had altered mental status of unclear etiology on admission. "Altered mental status that is severe or persistent" is one criteria for inpatient treatment of pneumonia, and this patient meets the criteria based on the documentation. Although she improved quickly and was stable for discharge after only one night in the hospital, the acuity of her presentation was sufficient to warrant medical necessity for inpatient admission.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Appendicitis
Treatment: Inpatient stay
The insurer denied the inpatient stay. The health plan's determination is upheld. 

The patient is a male with no past medical history (PMH) / PSH (past surgical history) with a 1-day history of abdominal pain. Physical exam was consistent with appendicitis. White blood cell count (WBC) was 23.24. A computed tomography (CT) A/P (abdomen/pelvis) was done and showed uncomplicated appendicitis He was admitted and underwent an appendectomy. He was discharged from the post-anesthesia care unit (PACU). Under review is the inpatient level of care.

The inpatient stay is not medically necessary. A lower level of care is appropriate.
Several studies have demonstrated safety of observation and even outpatient management of acute, uncomplicated appendicitis in pediatric patients. In Gee's study of 849 laparoscopic appendectomies, there was no difference in readmission rate for same day versus. observation of acute, uncomplicated appendicitis. This study concluded: Same-day discharge for laparoscopic uncomplicated appendectomy should be the new standard of care. This study found no differences in outcomes between the timing of discharge for patients discharged home the same day. In this case, the patient's stay was uncomplicated and could have been managed at a lower level of care.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Transient ischemic attack
Treatment: Inpatient Hospital Admission
The insurer denied: Inpatient Hospital Admission
The denial is overturned

The patient is an adult male who presented with sudden onset of headache followed by left sided weakness involving complete paralysis. He was unable to speak. A stroke code was called. 
Computed tomography angiogram (CTA) of the head and neck was done. Neurological checks were done every hour. Aspirin and Plavix were given. The patient was admitted with a diagnosis of transient ischemic attack and was placed on telemetry. Magnetic resonance image (MRI) was done. The inpatient admission was denied as it did not meet medical necessity for level of care.

The inpatient admission was medically necessary.

The patient had transient ischemic attack and as part of the workup, prolonged telemetry monitoring is necessary to evaluate for any causes of arrhythmia that could have precipitated the transient ischemic attack. Furthermore, the Milliman Care Guidelines (MCG) 25th edition indicates inpatient admission is warranted when there is a need for prolonged telemetry monitoring which was the case for this patient.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Cancer
Treatment: Proton beam therapy
The insurer denied proton beam therapy.
The health plan's determination is overturned.

This is the case of a male patient with history of L (left) tonsil cancer who was treated with radiation therapy (RT). He presented with recurrence and is being evaluated for a curative full dose of RT using proton beam therapy. 

The requested proton beam therapy is medically necessary for this patient.

This is a young patient with recurrent disease in a previously treated area and the plan is to treat with full dose curative RT. Proton beam therapy can provide the best coverage and delivers much less radiation to both parotid glands, constrictors, oral cavity, and other organs at risk (OAR). Proton beam therapy is medically necessary in this case.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Systemic lupus erythematosus (SLE) 
Treatment: Gazyva
The insurer denied: Gazyva
The denial is: Overturned

The patient is a female with a history of systemic lupus erythematosus (SLE) with overlap features diagnosed with disease manifestations including facial and vasculitic rashes, inflammatory myositis with Gottron's rash, arthritis, cytopenias, and hypocomplementemia. She has developed life and organ-threatening complications related to SLE including severe heart failure related to lupus cardiomyopathy, central nervous system (CNS) disease with subcortical white matter changes by magnetic resonance imaging (MRI), and class III lupus nephritis. She has previously received 6 months of 1gram per meter squared (g/m2) Cytoxan, high-dose Solu-Medrol pulses, prednisone, and is currently on mycophenolate 1g twice daily (BID), hydroxychloroquine 400 daily, and rituximab 1g x 2 every (q) 6 months (status post 4 full courses and had a dose of the 5th). Despite these treatments, disease remains active with ongoing cutaneous findings, worsening heart failure (ejection fraction continues to worsen, down to 25%) which is felt to be secondary to ongoing inflammation related to SLE. She has previously demonstrated respond to rituximab, but response is transient as patient has rapid repopulation of B cells. It is noted that obinutuzumab (Gazyva) has been shown to have a more durable effect on B cell depletion compared to rituximab. Further, the patient has developed severe side effects to rituximab including hypotension, which is believed to be secondary to anti-chimeric antibody production against rituximab. Treating physician is thus requesting switch to obinutuzumab which shows better efficacy in depleting B cells and thus maintaining SLE in remission.

Gazyva is medically necessarily and a potentially life-saving therapy in this case of adverse reaction to rituximab infusion and ongoing disease activity with SLE.
This patient clearly has severe life-threatening disease which warrants aggressive therapy. While Benlysta can be a helpful adjunct for cutaneous and joint disease, by itself it is not a reasonable next step for patients with severe life and organ-threatening disease (worsening cardiomyopathy). There is also concern for the use of Benlysta in this patient with depression and prior history of self-harm given its association with suicidal ideation. There is data to support the use of B cell depleting therapies and Gazyva specifically in SLE and those with lupus nephritis. B cell depleting therapies are often used among patients with CNS disease. As patient has previously demonstrated improvement with B cell depleting therapy but is now showing features of anti-chimeric antibody development and has rapid repopulation of B cells following rituximab infusion, Gazyva is a reasonable and medically necessary next step for this patient with life and organ-threatening SLE. There is a need for aggressive treatment of a life -threatening disease.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Cardiac/Circulatory Problems-Hypertension/High Blood Pressure
Treatment: Pharmacy/Prescription Drugs-Nebivolol
The health plan denied coverage of the prescription medication Nebivolol as the patient did not meet their formulary exception criteria. The reviewer has overturned the health plan's determination.

This case involves a patient with a history of hypertension and hyperlipidemia who has been treated with several antihypertensive medications to achieve adequate blood pressure control. However, the patient has had documented intolerances and significant side effects to formulary medications, metoprolol, propranolol, and nadolol prompting their discontinuation. The patient has tolerated well the non-formulary medication, nebivolol. 
The patient has demonstrated significant side effects to the formulary medications, metoprolol, nadolol, propranolol, prompting their discontinuation in the past. In addition, patient is tolerating nebivolol very well without side effects and is helping the patient control his blood pressure. For these reasons, prescription coverage for nebivolol should be granted because it is a superior alternative for this patient to maintain good blood pressure control (1). I recommend that the health plan's determination be overturned, and that coverage be granted for non-formulary medication, nebivolol, since the patient has met the plans non-formulary prescription medication criteria as discussed above.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Weakness.
Treatment:  Inpatient Hospital Admission.

The insurer denied Inpatient Hospital Admission.  The denial is upheld.

This elderly female presented with weakness and vomiting. She was recently diagnosed with COVID. She had decreased oral (PO) intake and had not gotten out of bed. The patient's vital signs were stable, and she was afebrile. Her oxygenation was 99% (percent) on room air. Her exam was unremarkable. The pertinent abnormal labs were as follows: COVID positive and creatinine 1.29. Chest x-ray showed no acute disease. Electrocardiogram (EKG) showed sinus bradycardia. 

The patient was admitted with a diagnosis of weakness. On the next day, the patient's vital signs were stable. There were no overnight events. Her diet was advanced. There was no need for treatment for COVID. Acute kidney injury improved. Her blood pressure medications were being adjusted. On day number two, there was no significant change. On day number three, the patient was discharged.

The proposed treatment is not medically necessary.

This patient was admitted with weakness secondary to COVID infection. The health plan denied coverage because the patient did not meet criteria for Musculoskeletal Disease, Neurology, and Viral Illness. The patient was hemodynamically stable. Oxygenation was normal on room air. The patient did not have altered mental status. Labs were remarkable for acute kidney injury. The patient did not have severe electrolyte abnormalities. Imaging was negative for pneumonia. The patient was admitted and received supportive care. Renal function rapidly improved. The patient was able to tolerate oral intake. She was medically stable. She had not failed an observation level of care. Acute inpatient admission was not medically necessary.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Lumbar back pain.
Treatment: Intracept procedure (Current Procedural Terminology (CPT) code 64628).
The insurer denied coverage for Intracept procedure (CPT code 64628).
The denial is upheld.

This patient has chronic low back pain. She has had Trigger Point Injections and Epidural Steroid Injections. She has also had Chiropractic therapy. Her physical exam does not show documented radiculopathy. Her magnetic resonance imaging (MRI) shows Modic type 1 changes at lumbar (L) 2 and L3.  It also shows disc extrusion at L2-L3 and at L5- sacral (S) 1 as well as an annular tear at L3-L4. The request is for radiofrequency (RF) ablation of the basivertebral nerves (BVN) at L2 and L3.	

Long-term comparative outcomes are not known. The publications to date have been company sponsored and had methodology flaws. There are no published data on long term complication rates. There are other evidence- based interventions available to this patient. This procedure is unlikely to be more beneficial than the standard approaches.

Conger et al (3) pointed out that all of the major studies while supportive, have been funded by the company:

"There is moderate-quality evidence that suggests this procedure is effective in reducing pain and disability in patients with chronic low back pain who are selected based on type 1 or 2 Modic changes, among other inclusion and exclusion criteria used in the published literature to date. Success of the procedure appears to be dependent on effective targeting of the BVN. Non-industry funded high-quality, large prospective studies are needed to confirm these findings."

Similarly, a clinical practice guideline (4) while favorable pointed out the limitations of the current literature:
- Industry funding is a potential source of study bias for the available data reviewed.
- Limited number of studies.
- Short-term follow up for the majority of studied patients.
- Unknown effect on the primary degenerative process

This procedure is not likely to be more beneficial than the standard of care.

In summary, the denial of the Intracept procedure (CPT code 64628) and coverage for the requested treatment should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risk are substantially increased over standard treatments.