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

Diagnosis: Anal Cancer.
Treatment: Proton Beam Radiation Therapy, Pre-service.
The insurer denied the Proton Beam Radiation Therapy, Pre-service.
The denial is upheld.

The patient is a female with a diagnosis of stage cT1N0M0 (clinical stage 1, no spread to lymph nodes or elsewhere) squamous cell carcinoma of the anal canal.  Definitive chemotherapy and radiation therapy was recommended, and proton therapy was requested.

No, the requested proton beam radiation therapy is not medically necessary.
Although proton beam radiation therapy has been shown to be safe and effective for certain tumors that are adjacent to critical structures such as CNS (central nervous system) lesion, there is insufficient clinical peer-review literature for supporting its routine use for anal cancer.

A  multi-institutional feasibility pilot study evaluated 25 patients with anal canal cancer treated with proton therapy concurrent with chemotherapy.  Twenty-three patients (92%) completed treatment per protocol, and two patients died on treatment.  The overall rate of clinical complete response was 88%. The two-year local failure, colostomy-free survival, progression-free survival, and overall survival are 12%, 72%, 80%, and 84%, respectively.  The authors concluded that "multi-institutional pilot study of PBS-PT (pencil beam scanning-proton therapy) with concurrent 5-FU/MMC (fluorouracil 5%/Mitomycin C), PBS-PT (pencil beam scanning-proton therapy) was found to be feasible. A phase 2 study of proton beam radiation therapy is currently underway."

In this case, a proton/photon comparison plan was done, and the proton plan was able to reduce dose to the bladder, small bowel, femoral head and iliac crest.  However, the doses to those structures were all within tolerance per Quantec limit for both the photon and proton plans.  Photon IMRT (intensity-modulated radiation therapy) has been shown to be safe and effective for the treatment of anal cancer and is currently the standard of care.  Proton beam radiation therapy, therefore, is not considered medically necessary because there is insufficient clinical data from well conducted randomized trials showing that proton therapy is superior or equivalent to photon IMRT (intensity-modulated radiation therapy) for the treatment of anal cancer.

There is insufficient clinical data from well conducted randomized trials supporting the use of proton therapy for anal cancer.  In fact, there are several phase I and II ongoing trials still evaluating the role of proton therapy for the treatment of anal cancer.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: lower back pain

Treatment: nerve block injections

The insurer denied coverage for nerve block injections

The denial is upheld. 

This female patient has a history of obesity, carpal tunnel syndrome, cervical radiculopathy, lumbar radiculopathy, migraines, and seizures. She presented to the Pain Management Specialist's office for the evaluation of lower back pain. During the office visit the urine drug screen was positive for alcohol. She was prescribed an additional 30 days of Oxycodone for back pain. The physician noted that the patient would continue to benefit from lumbar interlaminar injections.  

Helm et al.(1) reviewed the efficacy of epidural steroids and found:
"For radicular pain from central stenosis there is one moderate quality study, with Level IV evidence. For radicular pain caused by failed back surgery syndrome there is one moderate quality study, with Level IV evidence. For radicular pain from foraminal stenosis and for axial pain there is Level V evidence, opinion-based/consensus, supporting the use of transforaminal injections." 
Clinical practice guidelines(2) support performing epidural steroids for post-laminectomy: "The evidence for lumbar and cervical post-surgery syndrome based on one relevant, high-quality randomized controlled trial (RCT) with fluoroscopic guidance for caudal and cervical interlaminar epidural injections, with or without steroids, is Level II with moderate to strong recommendation for long-term improvement." However, here the response to therapy has been very modest and short-lived.  

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

The carrier's denial of coverage for the nerve block injections is upheld.  The medical necessity is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Facial Cellulitis
Treatment: Inpatient admission
The insurer denied the inpatient admission.
The denial is upheld.

The patient is a male. He presented with pain and swelling of the face. He had no fever or chills.

The patient was afebrile on presentation to the emergency room. His WBC (white blood count) was 8.1 with no left shift. The patient had recent dental extraction three weeks prior to admission. He was on oral antibiotic prior to hospital presentation (Cipro and clindamycin).

The patient was treated with IV (intravenous) Vancomycin. CT (computed tomography) suggested odontogenic source of infection and no abscess or lymphadenopathy. The patient left AMA (against medical advice).

No, the inpatient admission was not medically necessary.

Medical necessity for acute inpatient admission was not established. The patient had facial cellulitis under therapy, and stated presentation was for ENT (otolaryngology) evaluation at a later date, which could have been accomplished as an outpatient. The patient had no acute interventions, and he left AMA.

The health plan accurately assessed the record as not showing adequate justification for acute inpatient care in the absence of acute illness requiring that level of care or acute interventions.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Hepatitis B.
Treatment: Vemlidy 25mg OR TABS, Pre-service.

The insurer denied the Vemlidy 25mg OR TABS, Pre-service.  The denial is overturned. 

The patient is a male status post liver transplant, with chronic hepatitis B. He has failed Viread, and is doing well on Vemlidy. He has stage IV kidney disease and is unable to take entecavir. The physician (MD) is requesting continuation of Vemlidy.

Yes, the proposed treatment with Vemlidy is medically necessary.

The patient has chronic hepatitis B and is in need of treatment. He previously failed Viread, and was approved for Vemlidy due to a low glomerular filtration rate (GFR). As the patient is doing well on Vemlidy, as he previously failed Viread, and is unable to take entecavir due to renal disease, and as the patient has stage IV renal disease, the proposed Vemlidy is medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Cancer/Brain Cancer
Treatment: Pharmacy/Prescription Drugs
The health plan denied the requested prescription drug, Zolinza as not medically necessary. 
The health plan's determination is overturned.

The patient is a male with a diagnosis of relapsed neuroblastoma for which he has been treated with multiple therapies, including experimental therapy whose oncologist is requesting off label use of Zolinza as treatment, given bone marrow involvement of neuroblastoma. It is to be combined with Cisplatin based therapy. As this agent is considered off label for this indication, coverage of this service has been denied and hence, an external appeal has been requested.

I would recommend to overturn, in whole, the health care patient's determination of medical necessity.

The treatment of Zolinza is deemed medically necessary for this patient. Vorinostat (Zolinza) is currently Food and Drug Administration (FDA) approved for the management of relapsed T-cell lymphoma. Combining Vorinostat with Cisplatin may relax the chromatin structure and facilitate the accessibility of Cisplatin, thus enhancing its cytotoxicity. Such combinations may reduce the undesired adverse effects of Cisplatin. This particular combination has been looked at in several phase I trials with encouraging results.
Unfortunately, given its rarity, there is a paucity of data to establish the ideal therapeutic option in the case of a rare pediatric tumor who has experienced multiple relapses. Furthermore, the patient has already exhausted multiple options including a recent clinical trial.
In the absence of a viable clinical trial protocol and in accordance with a lack of standard options in this context, in a young patient with a difficult prognosis, it is my opinion that the patient's health care plan did not act in the best interest of the patient and should be allowed to receive the treatment suggested by his pediatric oncologist who is at an academic medical center.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Hereditary angioedema
Treatment: Kalbitor
The insurer denied the Kalbitor.
The determination is overturned.

The patient has a request for Kalbitor 10 milligrams per milliliter (mg/mL) vial for hereditary angioedema. She has low C4 (range 6-9), decreased c1 esterase inhibitor level (11) and function (24). She has a heterozygous Serpin Family G Member 1 (SERPING1) gene. She has gastrointestinal (GI) bloating and discomfort. At issue is the medical necessity of Kalbitor.

The Kalbitor is medically necessary. Per the United States Hereditary Angioedema (HAEA) Medical Advisory Board 2020 Guidelines for the Management of Hereditary Angioedema guidelines, "All patients with laboratory confirmed HAE should have access to at least 2 standard doses of a Food and Drug Administration (FDA)-approved on-demand medication for treatment of acute attacks. For patients without clear laboratory confirmation of HAE (ie, HAE-U), it is incumbent on the clinician to carefully document that onset and duration of response to the on-demand treatment is consistent with the expected pharmacokinetic/pharmacodynamic profile of the drug. Caution should be exercised in cases where the frequency or dose required for perceived improvement appears to be out of the expected range; validation that the diagnosis is correct should be revisited in these instances. The efficacy or tolerability of a given on-demand medication can vary between patients. The coordinating expert physician should work with each patient to define the optimal drug(s) for treating acute attacks. In cases where more than 1 on-demand drug is prescribed, the justification for use of more than a single drug should be explicitly documented by the physician and understood by the patient. Regular follow-up visits with the physician are necessary to monitor the frequency and outcome of on-demand treatments; the frequency of these visits will depend on the patient's course."

In this case, the Kalbitor is medically necessary as all patients with HAE should have access of an on demand medication regardless of history of attacks.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Mental Health. 
Treatment: Pharmacy/Prescription Drugs. 

The insurer denied: Vyvanse. 
The denial is upheld. 

The patient is a female diagnosed with attention deficit hyperactivity disorder (ADHD). Treatment with Vyvanse is the subject of this review. The patient is currently treated with Adderall XR 10 milligrams (mg); however, it is thought to cause side effects of dry mouth, depression, anxiety, and palpitations. The subject under review is the medical necessity for Vyvanse. 

The health plan's determination is upheld. 

The requested Vyvanse is not medically necessary. The patient does not have contraindication or intolerance to all of the available plan preferred alternatives. There is no sound medical evidence that the requested Vyvanse is superior to the available alternatives. 

The patient has tried and failed Adderall XR. This is an amphetamine based drug. The requested Vyvanse is also an amphetamine based drug. 
However, there is no documentation that the patient has tried and failed a methylphenidate based drug. These are the remaining plan preferred alternatives. These include Concerta, Ritalin LA, Metadate CD, Focalin XR. These drugs are considered a first-line treatment for ADHD. There is no compelling medical reason provided why the patient cannot use these medications. Furthermore, the use of a methylphenidate based drug is reasonable given that the patient has already tried and failed an amphetamine based drug and the patient is requesting another amphetamine based drug. 
Methylphenidate and its derivatives have been shown to be safe and effective for treatment of ADHD and are recognized for this indication by the Food and Drug Administration (FDA), literature, and compendia. Methylphenidate may improve ADHD symptoms including poor focus, impulsivity and hyperactive behavior.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Optic pathway glioma.
Treatment: Mektovi 15 milligram (mg) oral (OR) tabs.

The insurer denied coverage for Mektovi 15 milligram (mg) oral (OR) tabs.  The denial is upheld. 

This patient is a female child with a history of optic pathway glioma, status post chemotherapy. Magnetic resonance imaging with and without intravenous (IV) contrast showed an interval increase in size of the left intraorbital optic nerve glioma as compared to the previous study. Approval for Mektovi [binimetinib] is requested. 

The patient has a history of optic pathway glioma, status post chemotherapy. Magnetic resonance imaging with and without intravenous (IV) contrast showed an interval increase in size of the left intraorbital optic nerve glioma as compared to the previous study. 

Mektovi is being proposed based on targets identified in molecular testing. This use of any drug is part of personalized medicine, which is not generally accepted yet or supported by evidence in peer-reviewed literature. 

Mektovi does not have final approval from the appropriate regulatory bodies for treatment of intraorbital optic nerve glioma.

It is not known if the patient would be a good candidate for Mektovi. The use has not been proven for use in this patient's diagnosis. The patient has already had standard chemotherapy, and surgery is not considered an option. There are no guidelines or literature to guide treatment options for this patient's situation.

Mektovi 15 milligram (mg) oral (OR) tabs is not the best available treatment for this patient at this time, because its efficacy is unknown. 

The carrier's denial of coverage for Mektovi 15 milligram (mg) oral (OR) tabs should be upheld. The requested treatment is not likely to be more beneficial than any other standard therapy or service.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Optic pathway glioma.
Treatment: Mektovi 15 milligram (mg) oral (OR) tabs.

The insurer denied coverage for Mektovi 15 milligram (mg) oral (OR) tabs.  The denial is overturned.

This patient is a female child with a history of optic pathway glioma, status post chemotherapy. Magnetic resonance imaging with and without intravenous (IV) contrast showed an interval increase in size of the left intraorbital optic nerve glioma as compared to the previous study. Approval for Mektovi [binimetinib] is requested.

The patient presented in the past with left eye proptosis and was found to have a left anterior optic nerve tumor. She was treated with carboplatin and vincristine and completed her initial chemotherapy due to prolonged neutropenia. She recently had progressive disease, as noted per magnetic resonance imaging. The provider is recommending treatment with binimetinib.

Scientific evidence in peer-reviewed literature does support a result of improvement in health outcome.

Pilocytic astrocytomas are sometimes characterized as a chronic disease as the 10-year survival is greater than 95%. Gross-total resection is reported in 94% of cerebellar tumors, but only 3.2% of hypothalamic and/or chiasmatic tumors. The rate of progression ranges from 50% to 80% in tumors for which gross-total resection is not achievable. Increasing sophistication in genetic testing has allowed for the detection of specific mutations within tumor subtypes that could represent targets for individualized tumor treatment. 

In a recent publication by Robison et al. (2020), 57 children without neurofibromatosis type 1 were treated with binimetinib. 50% of patients had a demonstrated response with decrease in tumor size. The toxicities in the study group were manageable.

The use of Mektovi is not Food and Drug Administration (FDA) approved for this indication.
 
The patient has failed standard chemotherapy and would be a good candidate for treatment with Mektovi.

Mektovi 15 milligram (mg) oral (OR) tabs is the best available treatment for this patient at this time, as there are no other drugs choices available, which have been shown to be effective for the treatment of this patient's type of cancer. This treatment is likely to be more beneficial than any other standard therapy.

The carrier's denial of coverage for Mektovi 15 milligram (mg) oral (OR) tabs should be overturned.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Optic pathway glioma.
Treatment: Mektovi 15 milligram (mg) oral (OR) tabs.

The insurer denied coverage for Mektovi 15 milligram (mg) oral (OR) tabs.  The denial is overturned. 

This patient is a female child with a history of optic pathway glioma, status post chemotherapy. Magnetic resonance imaging with and without intravenous (IV) contrast showed an interval increase in size of the left intraorbital optic nerve glioma as compared to the previous study. Approval for Mektovi [binimetinib] is requested.

This patient has a diagnosis of left optic nerve glioma. The patient presented in the past with left eye proptosis and was found to have a left anterior nerve tumor on imaging. She was treated with standard chemotherapy carboplatin and vincristine. Therapy was discontinued prematurely related to prolonged neutropenia. Her tumor has been stable until Magnetic resonance imaging showed progressive disease. The plan was to start treatment with Mektovi, as standard chemotherapy was previously tried without success, and surgery is not an option at this time. The patient's neuro-oncologist feels binimetinib is the appropriate treatment for this patient. There are no clinical trials that are recruiting for binimetinib at this time.

The scientific evidence does support a result of improvement in health outcome.

As chemotherapy is the standard of care, when this fails or the patient has had a reaction, further treatment is needed. Mitogen-activated protein kinase enzyme (MEK) inhibitors are demonstrating a more tolerable profile and positive treatment response.

"While selumetinib is the most advanced drug in terms of efficacy and toxicity data in the neurofibromatosis type 1 (NF1) population, other MEK inhibitors (MEKi) such as trametinib, cobimetinib, or binimetinib, are currently being tested in early phase clinical trials, or as compassionate use, in children with optic pathway glioma (OPG), with or without NF1, and may be also considered" (Cassina et al. 2019).

Mektovi does not have final approval from appropriate regulatory bodies for this diagnosis, as there is no optimal clear standard of care, for this patient's case. Therefore, Mektovi is warranted to be used for humanitarian purpose in this patient's case. 

Mektovi is the best available treatment for this patient as this time, given there is no optimal clear standard of care for this patient's case.

The carrier's denial of coverage for Mektovi 15 milligram (mg) oral (OR) tabs should be overturned. This medication is likely to be more beneficial than any standard treatment.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Pelvic congestion syndrome
Treatment: Oupatient Ambulatory Surgery (MPI) code 37241 x 1
The insurer denied the Oupatient Ambulatory Surgery (MPI) code 37241 x 1
The denial is overturned.

The patient is a woman with chronic cyclical pelvic pain and pressure that correlates with her menses.  She is status post left gonadal vein embolization because of pelvic congestion syndrome symptoms on the left.  She now has right sided recurrence of symptoms.  Her physician ordered right ovarian vein embolization to treat her pelvic congestion syndrome.

Yes, the health plan should cover the proposed treatment.

This procedure has been the standard of practice to treat this subset of women for over twenty years, and there are multiple studies showing its efficacy. There are multiple studies from multiple institutions showing the efficacy of this technique and low procedural morbidity/mortality. Please see the response to question 3, below.

Yes, the requested therapy is likely to be more beneficial for the enrollee than any available standard therapy.
The study by Guirola et al found "embolization for PCS [pelvic congestion syndrome] resulted in pain relief in 90% of patients."

The Laborda et al study showed technical success was 100%, clinical success was achieved in 168 patients (93.85%), with complete disappearance of symptoms in 60 patients over five years after following 202 patients treated for pelvic congestion syndrome with gonadal vein embolization.

Thus, ovarian vein embolization for this woman's pelvic congestion syndrome is likely to be more beneficial for the enrollee than any available standard therapy.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Pelvic congestion syndrome
Treatment: Oupatient Ambulatory Surgery (MPI) code 37241 x 1
The insurer denied the Oupatient Ambulatory Surgery (MPI) code 37241 x 1
The denial is overturned.

The patient is a female with right lower quadrant pain, pelvic pain. The request is for ovarian vein embolization.

Yes, the health plan should cover the proposed treatment.

Ovarian vein embolization (also known as gonadal vein embolization) is now established and safe procedure. A recent large population review paper revealed, "Percutaneous embolization for PCS [pelvic congestion syndrome] is an effective method of treatment having a high percentage of symptom improvement (reported in 697 of 762 patients). Studies utilizing a VAS [visual analog scale] as a quantitative measure of symptom improvement report statistically significant overall symptom improvement comparing post treatment and pretreatment values with an average decrease of 5.7 within 0 to 10 scale." Also, a large population (23 retrospective and 7 prospective clinical studies were identified with a total of 3505 patients) review found that glue embolization is evidenced to be the most effective in preventing recurrence.

The requested procedure, ovarian vein embolization, is the standard treatment per societal standard.