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

Diagnosis: Prostate Cancer.
Treatment: Surgical Services (SpaceOAR Procedure).
The health plan denied the requested procedure. 
The health plan's determination is upheld.

At issue is a male with a 2.5 year history of known prostate cancer with a most recent prostate-specific antigen (PSA) of 6.8 ng/dL and a cancer grading Gleason Score of 7 on biopsy of prostate without magnetic resonance imaging (MRI) evidence of extra prostatic extension. The patient has opted for radiation therapy via external source and his treating physician plans the use of SpaceOAR. At issue is the beneficial nature of the SpaceOAR hydrogel implant.

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

At the current time in the peer reviewed literature, the use of SpaceOAR and equivalent devices have not shown a statistically significant benefit in patient outcome when compared to radiation therapy without spacer use, and have not had societal guidelines assign their use as standard of care. There are centers that consider the use of this Food and Drug Administration (FDA) approved device to be essential in delivery of maximal dosage of radiation to the entire prostate, but institutional preference has not risen above the level of investigational preference at this point in time.
Radiation therapy from external source for prostate cancer has not been shown to necessitate SpaceOAR use for equivalent outcomes in the literature or societal guidance at this time. Complications do exist with implantation and that risk is well documented in the literature as well, further inspiring investigation into its risk benefit in the treatment of prostate cancer.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Prostate Cancer
Treatment: Surgical Services (SpaceOAR Procedure)
The health plan denied the requested procedure. 
The health plan's determination is upheld.

The patient is a male with a diagnosis of cancer grading Gleason 7, cancer classification cT1c prostate cancer. He has elected to undergo radiation therapy for his prostate cancer. The medical necessity for a SpaceOAR rectal separator for rectal separation prior to radiation therapy is under review.

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

No. National Comprehensive Cancer Network (NCCN) guidelines for prostate cancer, 2019 states "Ideally, the accuracy of treatment should be verified by daily prostate localization, with any of the following: techniques of IGRT using computed tomography (CT), ultrasound, implanted fiducials, or electromagnetic targeting/tracking. Perirectal spacer materials may be employed when the previously mentioned techniques are insufficient to improve oncologic cure rates and/or reduce side effects due to anatomic geometry or other patient related factors, such as medications or comorbid conditions." The documentation does not support that daily prostate localization cannot be performed using routine techniques and no anatomic geometry or other patient related factors which increase side effects are identified.
European Association of Urology (EAU) guidelines on prostate cancer, 2018 states "Intensity modulated radio therapy (IMRT), with or without image guided radiotherapy practices (IGRT) is the gold standard for external beam radiation therapy (EBRT). Evolving techniques will therefore combine IMRT with some form of image-guided radiotherapy (IGRT), in which organ movement can be visualized and corrected for in real time, although the optimum means of achieving this is still unclear." The guidelines do not comment on use of spaceOAR system for prevention of rectal complications.
American Urological Association (AUA) guidelines on clinically localized prostate cancer, 2017 do not comment on the use of rectal spacer to be used during IMRT/IGRT.
As such, the use of the spaceOAR system is not considered a generally accepted standard of care for all patients undergoing IMRT. Hence, the request treatment would not be considered medically necessary.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Prostate Cancer
Treatment: Surgical Services (SpaceOAR Procedure)
The health plan denied the requested procedure. 
The health plan's determination is upheld.

This male with a favorable intermediate risk prostate cancer has requested coverage for treatment with the Space OAR gel placement (55874) in preparation for SBRT (Stereotactic Body Radiotherapy) radiation therapy.

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

No. While rectal complications may be less with this spacer, the difference between placebo is small-5.7% to 0%. The current American Urological Association (AUA) / American Society for Radiation Oncology (ASTRO) / Society of Urologic Oncology (SUO) Guideline for Localized Prostate Cancer does not endorse the use of a hydrogel spacer.
Per the current National Comprehensive Cancer Network (NCCN) Guidelines:
"Biomaterials have been developed, tested, and Food and Drug Administration (FDA) approved to serve as spacer materials when inserted between the rectum and prostate.342 In a randomized phase 3 multicenter clinical trial of patients undergoing image-guided intensity-modulated RT (IG-IMRT), with the risk of late (3-year) common terminology criteria for adverse events (CTCAE) grade 2 or higher, physician-recorded rectal complications declined from 5.7% to 0% in the control versus hydrogel spacer group. The hydrogel spacer group had a significant reduction in bowel quality of life (QOL) decline. No significant differences in adverse events were noted in those receiving hydrogel placement versus controls. Results of a secondary analysis of this trial suggest that use of a spacer may decrease the sexual side effects of radiation." While bowel QOL decline is reduced, NCCN does not indicate its use as a standard of care.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Neuralgia And Neuritis
Treatment: Pregabalin 75 mg (milligrams) Or Caps
The insurer denied the Pregabalin 75 mg (milligrams) Or Caps.
The denial is overturned. 

The patient is a male with history of chronic pain with multiple surgeries in his cervical and lumbar area.  He has been on multiple medications including gabapentin and hydrocodone.  He has been prescribed pregabalin 75 mg (milligrams).

Yes, the treatment with Pregabalin 75 mg (milligrams) is medically necessary.

The patient is a male with a history of chronic neuropathic pain.  He has had multiple surgeries.  He has a complicated past medical history.  He has taken various medications, including the plan recommended gabapentin.  He is on opiate medications.  He is considered high risk for opiate medications given his age and inconsistent urine drug screens, according to the attached documentation.  Pregabalin is a generic form of the medication Lyrica and is FDA (Food and Drug Administration)-approved for treatment of neuropathic pain (which the patient has) as well as post herpetic neuralgia, fibromyalgia, diabetic peripheral neuropathy, epilepsy.  The basis to the denial was the patient does not have an FDA (Food and Drug Administration)-approved diagnosis and has not failed one of the plan recommended medications.  Given that the patient has failed multiple medications, has neuropathic pain, has tried gabapentin, has had multiple surgeries, is already on opiate medications, an adjuvant nonnarcotic medication such as pregabalin is medically necessary and reasonable option in this patient.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Hallux abducto valgus, Bilateral plantar fasciitis. 
Treatment: Custom Shoe Inserts (L3000 x 2). 

The insurer denied coverage for Custom Shoe Inserts (L3000 x 2). 

The denial is overturned. 

This is a male patient with a medical history of bilateral plantar fasciitis, congenital pes planus of right foot, valgus deformity of both feet, metatarsalgia of left foot, and metatarsalgia of right foot. The patient was being followed for ongoing podiatry complaints. The patient complained of pain as well as a problem fitting his orthosis in his shoes. The patient also complained of a worn-out orthosis. The patient has trialed utilizing prefabricated orthotics without resolution for 3 months. The patient has also utilized anti-inflammatories with no resolution. The objective examination revealed pain with palpation of the first metatarsophalangeal joint, metatarsal head and plantar fascia as well as pain elicited with range of motion. There was also limited range of motion. There was evidence of hallux abducto valgus with decreased plantar fat pad. The patient had excessive pronation of both feet and rigid pes planus of right and left feet. A request was made for the use of custom foot orthotics with a deep heel cup. 
  
Based on the review of the medical record and literature, the request for custom orthotics is considered medically necessary for this patient. The use of custom orthotics for both hallux valgus and plantar fasciitis has been widely accepted by many clinicians and has proven to be an effective method to manage, reduce progression, for both conditions, as well as aid with alleviation of pain. Due to excessive pronation, otherwise referred to as hypermobility, this patient's midfoot joints of the feet collapse aggressively causing a biomechanical instability and excessive pressure to his first metatarsophalangeal joint, first ray, and plantar fascia. 

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

The carrier's denial of coverage for Custom Shoe Inserts (L3000 x 2) should be overturned. The medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Chronic Hepatitis C
Treatment: Epclusa
The insurer denied the Epclusa. 
The denial is overturned. 

The patient is a male who has the diagnosis of chronic hepatitis C. The patient has a genotype 1 infection. The patient has been treated in the past for this condition.  Specifically, the patient had tried and failed treatment with Harvoni as well as Zepatier. The patient has liver cirrhosis and also liver cancer. The patient has elevated liver enzymes. The health plan declined coverage of Epclusa, stating the patient must try and fail Mavyret first.

Yes, the requested treatment with Epclusa is medically necessary and appropriate as explained in detail below.

Given the elevated liver enzymes and presence of liver cancer, the patient has decompensated liver disease.  As such, the provision of Mavyret is contraindicated.

The patient is on two chemotherapeutic agents for his liver cancer, which, as per the provider, has caused GI (gastrointestinal) upset and lack of appetite.  Mavyret must be taken consistently with food.  As this ability is in question, it is not an appropriate option for the patient.  Epclusa does not require food during administration.

The FDA (Food and Drug Administration)-approved package insert states as follows:

"MAVYRET is a fixed-dose combination of glecaprevir, a hepatitis C virus (HCV) NS3 [nonstructural protein 3]/4A protease inhibitor, and pibrentasvir, an HCV (hepatitis C virus) NS5A [nonstructural protein 5A] inhibitor, and is indicated for the treatment of adult and pediatric patients 12 years and older or weighing at least 45 kg [kilograms] with chronic HCV [hepatitis C virus] genotype (GT) 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A)."

As such, Mavyret is not appropriate for this patient, as he has cirrhosis. The preferred plan alternative is Mavyret, but as noted, it cannot be used for this patient.

Therefore, given the above, the treatment with Epclusa is medically necessary for this patient.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis:  Skin Disorder. 
Treatment:  Pharmacy/Prescription Drug (Botox). 

The insurer has denied Pharmacy/Prescription Drug (Botox).  The denial is upheld.

The patient is a female with primary focal hyperhidrosis of the axillae.  The patient has tried topical solutions, such as Drysol, Certain-Dri, and over the counter antiperspirants.  Her condition causes severe anxiety and stress in public and work situations.  The patient has received Botox treatment over the past year.

The subject under review is whether the non-formulary Botox will be more effective than the health plan alternatives, such as anticholinergics, beta-blockers, or benzodiazepines.

The plan's determination is upheld.

No, the non-formulary Botox is not more effective than the plan alternatives. The standard treatment for a chronic condition, such as axillary hyperhidrosis [1-3] is a combination of carefully applied topical aluminum chloride and/or glycopyrrolate pads, as well as carefully-dosed oral anticholinergic therapies.  The duration of the use of topical Drysol and similar aluminum chloride drugs has not been provided, so treatment failure with these medications is not established.  The patient has not failed topical and oral anticholinergics, and other medications such as benzodiazepines.  The patient has not conclusively failed these first- and second-line medications, which usually are as effective as Botox for the majority of patients with axillary hyperhidrosis.  The formulary alternatives are of similar effectiveness to Botox injections, and in particular may be so for this patient, and if carefully dosed are with no greater adverse effects compared to Botox injections.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Central Nervous System/Neuromuscular Disorder. 
Treatment: Pharmacy/Prescription Drugs. 
The insurer denied: Brand Name Tecfidera. 
The denial is upheld in whole.

This is a female with a diagnosis of multiple sclerosis. An office note from the neurologist indicates complaints of worsening numbness and tingling in the legs, a "weird" feeling in the feet, restricted walking, requiring having to stop multiple times to regain balance, nervous about falling, and was not using stairs. She complained of numbness, tingling, and weakness, she had stable vision, and no urgency and frequency of urine. She was taking dimethyl fumarate, with increased stomach symptoms and nausea. Other medications are gabapentin, amlodipine, mirabegron, meloxicam and trazodone. Examination revealed abnormal strength of weakness in the right hip flexors, decreased sensation in the right lower extremity up to the knee and absence vibration sensation in toes that was diminished the ankles, slow and guarded gait with antalgia due to hip pain, inability to heel, toe and tandem walk and normal mental status, cranial nerve and coordination examinations. A brain magnetic resonance imaging (MRI) performed revealed no significant interval change in the overall the overall pattern of abnormal signal affecting the supratentorial white matter corpus callosum compared prior study. Cervical spine MRI revealed stable abnormal signal in the cervical spinal cord was prominent C3 through C5. A change back to brand-name Tecfidera due to intolerable gastrointestinal (G.I.) side effects from generic dimethyl fumarate was recommended.

The health plan's determination is upheld in whole.

No. Tecfidera is a multiple sclerosis disease-modifying medication that is now available as generic dimethyl fumarate. The patient had an adverse effect with generic dimethyl fumarate (gastrointestinal adverse effects) that she did not have with brand-name Tecfidera, indicating an adverse reaction to a non-active ingredient. As non-inactive ingredients differ between different manufacturer preparations, it is possible that she would not have the adverse effects to the Teva preparation that she had to the Mylan preparation. A trial of the Teva generic would be reasonable prior to considering reinitiation of brand-name Tecfidera as she may not have the adverse effects to dimethyl fumarate that she did with the Mylan product. Therefore, specific use of brand-name Tecfidera as opposed to a trial of generic Teva-produced dimethyl fumarate is not medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Major depressive disorder

Treatment: Ketamine infusions 14 units

The insurer denied coverage for Ketamine infusions 14 units.

The denial is overturned. 

This is a female patient who reportedly had depressive symptoms including depressed mood, anhedonia, apathy, lack of interest and motivation, and sleeping problems. She had diagnoses of major depressive disorder and post-traumatic stress disorder (PTSD), as she also had reports of trauma issues. She is said to have tried and failed multiple antidepressant medications including Prozac, Wellbutrin, Effexor, Trintellix, Pristiq, and also took anti-anxiety medication including Xanax, Ativan, and Klonopin. She reportedly had cognitive-behavioral therapy (CBT), dialectical behavior therapy (DBT), and family therapy as well. The patient reportedly was receiving ketamine infusions with significant reported efficacy as it was reported that she had no suicidal thoughts after taking this, had a desire to live, happiness, pleasure in life that she stated she did not know existed, and after a few treatments, she was able to use DBT and CBT skills that stopped all suicidal thoughts.  
  
The insurer denied coverage for ketamine infusions 14 units as not medically necessary. They stated that the patient's symptoms have improved to an extent that treatment can continue with evidence based treatment such as medication and psychotherapy. This reviewer disagrees with the insurer's decision to deny coverage for ketamine infusions 14 units. Medical literature supports the use of ketamine infusions for the treatment of major depressive disorder. 

As discussed in Up to Date, "Ketamine is a racemic mixture of two enantiomers, S-ketamine (esketamine) and R-ketamine. Ketamine is a standard anesthetic drug that is also administered for analgesia and sedation. In addition, ketamine and esketamine can rapidly and transiently alleviate treatment-resistant unipolar major depression, including suicidal ideation." 

There is sufficient literature and studies showing the efficacy of ketamine in the treatment of major depressive disorder. This patient had reports of treatment resistant depression and tried 5 antidepressant trials and CBT and DBT therapy without reported efficacy but had reported efficacy when treated with ketamine infusions including less depressive symptoms, no suicidal thoughts, a desire to live, happiness, pleasure in life that she stated she did not know existed, and improved functioning as a mother, wife, and functional member of society. Also, after a few treatments, she was able to use DBT and CBT skills that stopped all suicidal thoughts. It was reported that she needed more treatments to complete remission and not relapse. 

Ketamine infusions 14 units are medically necessary. The plan did not act reasonably with sound clinical judgment and in the best interest of the patient as she reportedly improved with this treatment.

The medical necessity for Ketamine infusions 14 units is substantiated. The insurer's denial is overturned.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Sickle cell crisis

Treatment: Inpatient admission

The insurer denied coverage for the inpatient admission.

The denial is overturned.

This is a male patient who was admitted for sickle cell crisis. The patient had been ineffectively treated both in the Emergency Department (ED) and on an outpatient basis. The patient was admitted and treated with intravenous (IV) Dilaudid and other IV medications to treat his crisis.

As per Shah et al. (2018), "sickle cell disease (SCD) is a chronic condition characterized by multiple vaso-occlusive complications, including acute pain crisis. The mainstay of treatment for patients presenting with vaso-occlusive crisis (VOC) is pain control and adequate hydration. Currently, there are no studies to determine an optimal pain control regimen in adult SCD patients." Thus, Shah et al.'s (2018) study found that "it is reasonable to initiate [patient controlled analgesia (PCA)] as the primary pain treatment strategy in SCD patients presenting in VOC." As per Cooper et al. (2019), "Vaso-occlusion can lead to an acute, painful crisis (sickle cell crisis, vaso-occlusive crisis (VOC) or vaso-occlusive episode). Pain is most often reported in the joints, extremities, back or chest, but it can occur anywhere and can last for several days or weeks. The bone and muscle pain experienced during a sickle cell crisis is both acute and recurrent. Key pharmacological treatments for VOC include opioid analgesics, non-opioid analgesics, and combinations of drugs. Non-pharmacological approaches, such as relaxation, hypnosis, heat, ice and acupuncture, have been used in conjunction to rehydrating the patient and reduce the sickling process."

While sickle cell pain can often be handled on an outpatient basis, the need for hydration and to exclude life-threatening complications makes a short hospitalization reasonable at the acute level of care. First, assessment of pain is necessarily subjective and there is not yet an objective and reliable method of accurately assessing and quantifying the patient's pain experience. As a result, physicians must rely on the patient's self-report of pain. In this case, the patient with sickle cell disease presented with severe joint pain of 10 out of 10 in severity that was refractory to treatment with methadone and Percocet. The patient needed an inpatient level of care and monitoring for his pain. Literature supports that hospitalization is appropriate to administer stronger forms of analgesia or higher doses titrated to the patient's needs. Thus, the inpatient admission was medically necessary for this patient. 

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

The carrier's denial of coverage for the inpatient admission should be overturned. The medical necessity is substantiated.