Persius/hicric huggingface dataset:
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 2

A 39-year-old male enrollee has requested authorization and coverage for corticotropin (H.P. Acthar Gel) injections, up to 40 units. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that the requested medication is not considered the standard of care for this patient. The 2015 American College of Rheumatology (ACR) guidelines recommended methotrexate with or without a tumor necrosis factor inhibitor as the next treatment in those who have failed methotrexate alone. There are also multiple studies demonstrating efficacy and safety of tumor necrosis factor inhibitors in treating moderate to severe rheumatoid arthritis. In this case, there is no documentation of failure of first-line therapy as recommended by the ACR or contraindication to such trials. There is evidence that a second tumor necrosis factor inhibitor is effective in those who have tried and failed a previous tumor necrosis factor inhibitor or have had adverse reactions to another tumor necrosis factor inhibitor. There is a lack of support for the use of corticotropin (H.P. Acthar Gel) injections in this clinical setting. The medical records note that the patient has been on H.P. Acthar Gel for greater than one year. Use beyond an acute exacerbation is not within the U.S. Food and Drug Administration (FDA) indication. In sum, corticotropin (H.P. Acthar Gel) injections, up to 40 units is not likely to be more beneficial than other available treatment options.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 3

A 39-year-old male enrollee has requested authorization and coverage for corticotropin (H.P. Acthar Gel) injections, up to 40 units. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that the records document that the patient has been diagnosed with rheumatoid arthritis, episcleritis and scleritis. He has been treated with prednisone and CellCept, without adequate response. The patient has requested coverage for H.P. Acthar Gel to improve symptoms and objective findings of rheumatoid arthritis. The current medical evidence does not support the requested medication in this clinical setting. Per the evidence-based guidelines, H.P. Acthar Gel is not recommended for the treatment of rheumatoid arthritis. Thus, corticotropin (H.P. Acthar Gel) injections, up to 40 units, is not likely to be more beneficial than other available treatment options.
Appeal type: Medical Necessity
Decision: Insurer Denial Upheld

Summary Reviewer 

The patient is a 14-year-old male with a history of short stature. He presented to his endocrinologist on 7/06/20. The physician reviewer found that this patient has a history of short stature. He is not growth hormone deficient as shown by the growth hormone stimulation test done in 5/28/20. He has a strong family history of constitutional delay. On 7/06/20, he was examined and was found to be in puberty and he mostly likely will continue to grow even without growth hormone therapy. Growth hormone therapy is not medically necessary in his case as his clinical indication does not fit into the category of idiopathic short stature (ISS). His final predicted height is 5a5.5a, which is above the cut off of treatment of ISS. Therefore, Humatrope is not medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 1

A 65-year-old female enrollee has requested authorization and coverage for proton beam radiation therapy. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that Proton beam radiation therapy is a standard of care and medically appropriate in this clinical setting. This patient has received external beam radiotherapy to her left parotid region in the past. It is imperative to minimize the volume of normal tissue re-exposure in order to reduce the risk of treatment-related morbidity. The provider performed a proton/intensity modulated radiation therapy (IMRT) comparison plan which revealed that there was excessive cumulative exposure to the patients surrounding normal tissues with the IMRT plan, while the proton radiation plan was able to reduce this exposure to within known safe normal tissue tolerance limits. Proton beam radiation therapy is the most appropriate radiation modality in this setting. Therefore, proton beam radiation therapy is likely to be more beneficial than other treatment options.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 2

A 65-year-old female enrollee has requested authorization and coverage for proton beam radiation therapy. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that in the majority of cases, the standard approach to treat this malignancy is with standard photon techniques using IMRT. However, in this case, the patient has undergone radiation to the area once in 1987. Treatment with protons would be expected to reduce the integral dose to the surrounding structures such as the brainstem, spinal cord, temporal lobe and oral cavity compared to standard treatment with photons. This would result in a meaningful reduction in acute and long-term toxicities compared to treatment with standard photons due to the patients past history of radiation therapy to this site. All told, the requested proton beam radiation therapy is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 3

A 65-year-old female enrollee has requested authorization and coverage for proton beam radiation therapy. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that compared to standard radiotherapy with photon IMRT, the benefit of proton therapy is that with its Bragg Peak, radiation dose is deposited more precisely on its target. This translates into a decrease in exposure of normal tissue in the low-dose to intermediate-dose range, but not in the high-dose range. The medical records support proton beam radiation therapy in this patients case, given the significant prior dose her adjacent normal tissue was exposed to from her radiation therapy in 1987. Radiation techniques at that time were much more crude, with little normal tissue sparing. Critical structures that likely received near full tolerance dose for this patient include the brainstem, spinal cord, carotid artery, and cranial nerves. Additionally, her jaw would be at risk for osteoradionecrosis with another full dose of radiotherapy. Thus, the requested proton beam radiation therapy is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 1

A 48-year-old female enrollee has requested authorization and coverage for a Cochlear Baha Attract System.  The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.  The physician reviewer found that the requested services are not likely to be more effective for this patient than other available options. The Cochlear Baha Attract Hearing device has been adapted from its predecessor. Instead of having a bone-anchored external device requiring cleaning and maintenance, the Attract device is magnetically attracted to a surgically implanted magnet integrated into the bone of the skull. The external sound processor picks up sound vibrations from the environment. The sound processor passes the sound vibrations to the attached external magnet that attracts to the internal magnet. The sound vibrations are transferred through the magnetic attachment to the small titanium implant inserted in the bone behind the ear. The sound vibrations are then sent directly through the bone to the inner ear (cochlea) where they are converted into electrical impulses by tiny hair cells inside the cochlea. These impulses travel to the brain, allowing the patient to perceive sound naturally. The current medical evidence for the use of this device is limited to several small investigational reports. Iseri and colleagues reported on 12 patients and suggested the implant is promising and comparable to the percutaneous systems. Briggs and colleagues reported on 27 patients for up to nine months and stated improvement in speech understanding, but the investigation was not validated by others.  It is for the lack of other statistical evidence that this type of device has not been established as superior compared to standard treatments. The newest reports confirm evidence that the magnetic systems do provide excellent results to improve the hearing of patients with single-sided deafness. All told, the requested is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 2


A 48-year-old female enrollee has requested authorization and coverage for a Cochlear Baha Attract System.  The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.  The physician reviewer found that The Cochlear Baha Attract System is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The study by Gawecki and colleagues evaluated surgical, functional and audiological results of the Baha Attract System. The authors concluded that the data obtained prove the safety and effectiveness of the Baha Attract system in patients with conductive and mixed hearing loss as well as in patients with single-sided deafness. Cosmetic aspects are highly acceptable and the idea of Attract itself is important for patients with limited manual dexterity. In addition, the Cochlear Baha Attract System is U.S. Food and Drug Administration approved device for the treatment of unilateral deafness. In this case, the patient is suffering from unilateral profound hearing loss with normal hearing in the other ear. As such, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 3


A 48-year-old female enrollee has requested authorization and coverage for a Cochlear Baha Attract System.  The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.  The physician reviewer found that The Cochlear Baha Attract System has not been established as likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Although the Cochlear Baha Attract System is approved by the U.S. Food and Drug Administration, in this patients case it is not likely to be more beneficial than the traditional Baha Connect System. Based on the medical literature and clinical documentation submitted for review, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Insurer Denial Upheld

Summary Reviewer 

The patient is a 63-year-old female who was diagnosed with metastatic colon cancer in December 2017. She was treated with surgery, but chemotherapy was delayed due to a patellar fracture, and she developed carcinomatosis. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested medication. Kuter suggests that reduction in chemotherapy dose/frequency or alteration of regimen and platelet transfusions are the standard of care. Thrombopoietin receptor agonists such as eltrombopag are an alternate in patients who cannot be supported with transfusion and for whom reduction in dose/frequency would negatively impact survival. In this patients case, there is no indication that she could not be supported with either dose/regimen change or platelet transfusions.
Of note, the patients platelets are above the threshold for treatment with oxaliplatin, which is part of FOLFOX. Treatment with oxaliplatin only requires a platelet count of 75,000, which the patient has had. Therefore, Promacta 50 mg tablets are not medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Insurer Denial Upheld

Summary Reviewer 


A 29-year-old female enrollee has requested reimbursement for the inpatient admission services provided from 4/27/17 through 4/28/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees lymphadenopathy. The physician reviewer found that this patients records did not document emergency or life threatening signs or symptoms that necessitated a hospital admission. The patients history, physical examination, laboratory or radiographic evaluation did not indicate the patient was in imminent danger, acutely ill, or medically unstable. For this reason, the work-up could have been performed on an outpatient basis. Accordingly, the inpatient admission services provided from 4/27/17 through 4/28/17 were not medically necessary for treatment of the patients medical condition. Based on the foregoing discussion, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 1

A 56-year-old male enrollee has requested reimbursement and prospective authorization and coverage for J1602, Simponi 50 mg, injected monthly for one year from 9/20/18 forward. The Health Insurer has denied this request indicating that the medication at issue was and is considered investigational for treatment of the enrollees autoimmune hearing loss. The physician reviewer found that autoimmune inner ear disease is sensorineural hearing loss, caused by an abnormal immune system response. The clinical expression of immune-mediated inner ear disease typically benefits from steroid and immunosuppressive therapy. There are no standardized diagnostic criteria or reliable diagnostic tests for the diagnosis of autoimmune inner ear disease. The diagnosis is based on exclusion. The safety and efficacy of intratympanically injected golimumab for patients with autoimmune inner ear disease was evaluated by Derebery and colleagues. While the study was limited, there were no serious adverse events. There is support for the medication at issue for the treatment of this patient who is no longer responsive to Imuran, Atabrine, or azulfidine. Thus, J1602, Simponi 50 mg, injected monthly for one year from 9/20/18 forward was and is likely to be more efficacious than other treatment options. Based upon the information set forth above, the medication at issue was and is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 2

A 56-year-old male enrollee has requested reimbursement and prospective authorization and coverage for J1602, Simponi 50 mg, injected monthly for one year from 9/20/18 forward. The Health Insurer has denied this request indicating that the medication at issue was and is considered investigational for treatment of the enrollees autoimmune hearing loss. The physician reviewer found that this patient has a history of autoimmune hearing loss. He has been treated with steroids and other agents. The patients provider recommended Simponi, an anti-tumor necrosis factor (TNF) agent. Anti-TNF agents have been tried in autoimmune hearing loss as an intratympanic injection in two very small studies by Derebery and colleagues and Van Wijk and colleagues. There was no control group and no randomization in either of the two studies. At this time, there is a lack of evidence demonstrating that Simponi has an effect on autoimmune hearing loss. In sum, J1602, Simponi 50 mg, injected monthly for one year from 9/20/18 forward was not and is not likely to be of greater benefit than other treatment options. Based upon the information set forth above, the medication at issue was not and is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 3

A 56-year-old male enrollee has requested reimbursement and prospective authorization and coverage for J1602, Simponi 50 mg, injected monthly for one year from 9/20/18 forward. The Health Insurer has denied this request indicating that the medication at issue was and is considered investigational for treatment of the enrollees autoimmune hearing loss. The physician reviewer found that idiopathic sudden sensorineural hearing loss is hearing loss of at least 30?dB in at least three contiguous frequencies within at least 72 hours. There are many different theories to explain it, and many different modalities are used for its management, such as systemic steroids, intratympanic steroid injection, hyperbaric oxygen therapy, antiviral drugs, and vasodilators or vasoactive substances. Autoimmune inner ear disease assumes that there is an autoimmune component of the etiology of the hearing loss. Derebery and colleagues evaluated the safety and efficacy of intratympanically injected golimumab as a steroid-sparing agent for patients with steroid-dependent autoimmune inner ear disease. The results demonstrated that this treatment stabilized hearing in 3 of 7 per-protocol subjects with autoimmune inner ear disease and allowed a complete tapering off of prednisone in those seven subjects. The authors noted that studies with larger samples sizes are warranted. Haynes and colleagues reported difficulty in proving efficacy of a single modality is present in all studies on sudden sensorineural hearing loss secondary to multiple treatment protocols, variable rates of recovery, and a high rate of spontaneous recovery. At this time, the current peer-reviewed scientific medical literature is insufficient to establish the clinical utility, safety and efficacy of this treatment in this clinical setting. Thus, J1602, Simponi 50 mg, injected monthly for one year from 9/20/18 forward was not and is not likely to be of greater benefit than other available treatment modalities. Based upon the information set forth above, the medication at issue was not and is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 1

A 42-year-old female enrollee has requested reimbursement and prospective authorization and coverage for the Optune device with transducer arrays provided from 3/8/17 forward. The Health Insurer has denied this request indicating that the equipment at issue was and is considered investigational for treatment of the enrollees glioblastoma multiforme.   The physician reviewer found the patient is a 42-year-old female who  has a history of glioblastoma multiforme status post gross total resection, treatment with Temodar concurrent with radiation, followed with temozolomide in combination with tumor treatment fields (TTF) therapy with the Optune device. The patient started Optune therapy on 3/8/17. The patient has requested reimbursement and prospective authorization and coverage for the Optune device with transducer arrays provided from 3/8/17 forward. The Health Insurer has denied this request indicating that the equipment at issue was and is considered investigational. Optune is a wearable and portable, U.S. Food and Drug Administration (FDA) approved device that has been shown in clinical trials to safely deliver continuous therapy to the area of the brain where glioblastoma multiforme tumors are located. Optune is a noninvasive regional therapy that targets dividing cancer cells in the brain and generally does not harm healthy cells. The National Comprehensive Cancer Network (NCCN) guidelines have updated the recommendation for the treatment of glioblastoma multiforme. For the treatment of patients with glioblastoma multiforme with good performance status, a 2A recommendation was added for a treatment option for standard brain radiotherapy, with concurrent temozolomide and adjuvant temozolomide and TTF therapy. Overall, the addition of TTF to maintenance temozolomide chemotherapy can prolong progression free survival. Given these findings, the Optune device with transducer arrays provided from 3/8/17 forward was and is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the equipment at issue was and is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.