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

Genetic Diseases. 
Pharmacy/Prescription Drugs. 

Diagnosis: Spinal Muscular Atrophy. 
Treatment: Evrysdi. 

The insurer denied Evrysdi. The health plan's determination is overturned. 

The patient is a woman with spinal muscular atrophy (SMA). The patient is wheelchair dependent. Most recently, the patient has been treated with Spinraza. However, the provider notes a functional decline in the ability to chew and use the arms. Treatment with Evrysdi is the subject of this review. 

Evrysdi is medically necessary for this patient. 

The patient has spinal muscular atrophy. Evrysdi (risdiplam) is Food and Drug Administration (FDA) approved for treatment of spinal muscular atrophy. The request is on-label. Risdiplam is a small molecule SMN2 splicing modifier that binds two sites in SMN2 (Survival of motor neuron 2) pre-messenger ribonucleic acid (RNA), thereby correcting the splicing deficit of SMN2, leading to increased levels of full-length SMN (survival motor neuron) protein. Risdiplam was approved by the FDA in August 2020 for the treatment of SMA in patients two months of age and older. 

An open-label study (FIREFISH) of risdiplam included 21 symptomatic infants with SMA type 1 who were one to seven months of age at enrollment. After 12 months of treatment at the higher dose (0.2 mg/kg per day), the number able to sit without support for at least 5 seconds was 7 of 17 patients (41 percent), and the number alive without permanent ventilation for both high and low dose groups was 19 of 21 patients (90 percent). At 23 or more months, the number of patients alive without permanent ventilation was 17 (81 percent). These outcomes were far better than those expected from the natural history of SMA disease progression. A controlled trial (SUNFISH) published in abstract form randomly assigned 180 patients ages 2 to 25 years with SMA type 2 or non-ambulant SMA type 3 to treatment with risdiplam or placebo in a 2:1 ratio. Outcome (motor function) was assessed by the 32-item Motor Function Measure score (MFM36). At one year, risdiplam treatment led to clinically meaningful improvement, with an average increase in MFM36 score of 1.36, compared with an average 0.19 decrease in MFM36 score for the placebo group. It is not necessary to perform the standardized motor scores in order for a patient to receive benefit from the drug.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Bone Metastases
Treatment: Radiation Therapy
The insurer denied the Radiation Therapy.
The denial is overturned. 

The patient is a female with a history of paraganglioma s/p (status post) surgical resection of the primary four years ago. The patient subsequently presented with biopsy proven recurrent oligometastatic paraganglioma to L4 spine (fourth lumbar spine vertebra) and right proximal femur. Palliative therapy was recommended, and 3D (three-dimensional) conformal radiation therapy with IGRT (image-guided radiation therapy) to L4 spine was requested.

Yes, the Radiation therapy for bone metastases is medically necessary.

Radiation therapy has been shown to be safe and effective for the treatment of symptomatic bone metastasis and is the standard of care. Two-dimensional (2D) (which is being suggested by the health plan in the form of complex isodose treatment) or three-dimensional (3D) conformal radiation therapy is the standard radiation technique for the palliative treatment of bone metastasis. In this case, the patient's physician stated that dose escalation is needed as it has been shown to improve local control for paraganglioma. Given that there are surrounding critical structures that need to be spared due to dose escalation, three dimensional (3D) conformal radiation therapy would be a preferred radiation technique, as the surrounding structures can be clearly visualized during the planning process to provide a more accurate conformal radiation delivery.

IGRT is a method of tumor localization during the delivery of radiation therapy. This procedure is performed during the actual radiation therapy delivery session. It is a technique used to compensate for the movement of the tumor and/or patient during radiation therapy to accommodate breathing motions. It provides accurate and objective monitoring of the patient's alignment and motion as well as the tumor's position. The information from IGRT is used to adjust the patient's position for optimal radiation dosing to the target area while sparing adjacent healthy tissue or organs. It is typically used in patients with tumors located near or within critical structures and/or in tissues with setup variations. IGRT is an FDA (Food and Drug Administration)-approved procedure and it is not subject to IRB (institutional review board) review.

In this case, because of the dose escalation regimen planned, the total dose planned would likely exceed tolerance of the surrounding critical structures such as the cauda equine if the target is not accurately localized with IGRT. The requested 3D and IGRT for the treatment of L4 spine, therefore, is medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Osteoarthritis.
Treatment: Continued hospital stay.

The insurer denied coverage for the continued hospital stay. The denial is upheld.

This is a male patient with a history of osteoarthritis. The patient presented to the hospital with complaints of severe progression of osteoarthritis for the past two years. The patient was admitted to inpatient rehabilitation services with osteoarthritis of the knee. The patient had a right total knee replacement on the day of admission. The patient tolerated the procedure well with no complications. After surgery, the patient was given antibiotics for 24 hours for prophylaxis and aspirin for deep vein thrombosis prophylaxis. The orthopedic course was uneventful. The patient's pain was managed by the Acute Pain Services and the patient was transitioned to oral pain medications. On days 3 and 4 of admission, the physical therapist noted that the patient would benefit from continued skilled physical therapy services to maximize functional mobility. The patient tolerated the physical therapy sessions well and achieved goals needed for discharge. Upon discharge on day 4 of admission, the patient's surgical site was clean, dry, and intact.

Based on the review of the medical record, the patient had a non-complicated post-surgical course. The patient's physical therapy records on day 2 of admission report no complaints. The patient was able to walk 40 and 75 feet with limited assist. There were no documented adverse effects. The plan of care status for day 2 of admission reported no problems and discharge arrangements were being made for home care. The patient's pain was adequately managed with oral analgesia. The patient's vital signs were stable. There were no problems with his surgical wound. The patient had satisfactory motion. The patient did not require treatment for underlying medical problems. There were no medical reasons to substantiate an ongoing length of stay as provided. The patient's physical therapy (PT) services could have been obtained as outpatient or at home. 

The continued hospital stay from days 3 and 4 of admission is not considered medically necessary for this patient.

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

Based on the above, the medical necessity for the continued hospital stay is not substantiated. The insurer's denial should be upheld.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Dental Problems (skeletal Class I, Class II canines, maxillary and mandibular crowding, deep bite, excessive overjet and impacted right maxillary canine).
Treatment:  D8080 Braces.

The insurer denied coverage for D8080 Braces.  The denial is upheld. 

This is a female patient, who presented for evaluation for orthodontic care.  The orthodontist recommended comprehensive orthodontics due to skeletal Class I, Class II canines, maxillary and mandibular crowding, deep bite, excessive overjet and impacted right maxillary canine.  The orthodontist has completed the Handicapping Labio-Lingual Deviation (HLD) index and has chosen the automatically qualifying condition of impacted permanent anteriors where extraction is not indicated.  The insurer has denied coverage for orthodontic treatment as not medically necessary, stating that the clinical circumstance does not meet the required handicapping malocclusion medical necessity requirements on the HLD index.

Upon review of the documentation, it is evident that the patient exhibits a malocclusion.  However, to assess for severity of the malocclusion and, therefore, medical/dental necessity for orthodontic care the HLD 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 impacted permanent anteriors where extraction is not indicated.  This reviewer finds that this automatically qualifying condition criterion is not met and does not support comprehensive orthodontic care.  This reviewer concurs with the findings of the insurer of attaining 10 points on HLD index (i.e., 3 points overjet, 4 points overbite, 3 points labiolingual spread). 

Thus, D8080 Braces are not considered medically necessary for this patient.

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

Based on the above, the medical necessity for D8080 Braces is not substantiated.  The insurer's denial should be upheld
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis:  Postherpetic neuralgia.
Treatment:  Peripheral electrical nerve stimulator.

The insurer denied coverage for the peripheral electrical nerve stimulator.  The denial is overturned. 

This is a male patient with a past medical history of arthritis, postherpetic neuralgia, complex regional pain syndrome, and spinal stenosis.  The patient presented for a follow-up of an acute flare-up of his underlying chronic low back pain from postherpetic neuralgia.  The patient had been treated with facet joint injections and dorsal root ganglion (DRG) spinal cord stimulator.  The provider requested a trial of a peripheral nerve stimulation of the left transversus abdominal plexus and right thoracic intercostal nerves.  The provider noted the patient had failed all pain therapies and was not a surgical candidate.  The patient was cleared for a trial of peripheral nerve stimulator.  The patient underwent placement of a peripheral nerve stimulator trial, Stim Wave nervous system involvement and Complex regional pain syndrome I of other specified site.  The patient tolerated the procedure. 

Stimwave, which is peripheral nerve stimulation technology, received Food and Drug Administration (FDA) clearance for treatment of severe intractable chronic pain of peripheral origin.  Literature review supports evidence in peer-reviewed literature that this treatment results in improvement in health outcomes. In this case, the patient has a diagnosis of post herpetic neuralgia and complex regional pain syndrome (CRPS), both of which are chronic neuropathic pain conditions which can affect peripheral nerves.  The patient has failed conservative treatment including medications, physical therapy, and had psychological clearance for peripheral electrical nerve stimulator.  The peripheral electrical nerve stimulator provided has final approval from the appropriate regulatory bodies for this diagnosis.

Therefore, peripheral nerve stimulation is likely to be more beneficial than any of the standard treatments/procedures for this patient

The carrier's denial of coverage for the peripheral electrical nerve stimulator should be overturned.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis:  Postherpetic neuralgia.
Treatment:  Peripheral electrical nerve stimulator.

The insurer denied coverage for the peripheral electrical nerve stimulator.  The denial is upheld. 

This is a male patient with a history of arthritis, postherpetic neuralgia, abdominal complex regional pain syndrome, and spinal stenosis.  The patient presented to an office visit with a Pain Medicine Specialist for a follow-up for an acute flare up of his underlying chronic low back pain and postherpetic neuralgia pain.  The patient underwent Peripheral Trial Nerve Stimulator implantation of Left Transversus Abdominus Plexus and Anterior Abdomen with 2 leads and Peripheral Trial Nerve Stimulator implantation of Lower Left Thoracic Intercostal nerves with 2 leads.

The patient has spinal cord stimulation (SCS) in place but has a broken lead.  The request is for placement of a peripheral nerve stimulator spanning more than 2 nerves.  As per Visnjevac, et al.'s Comprehensive Outcome Review of SCS for Complex Regional Pain Syndrome (CRPS), "spinal cord stimulation remains a favorable and effective modality for treating CRPS  with high-level evidence (1B+) supporting its role in improving CRPS patients' perceived pain relief, pain score, and quality of life.  In contrast, the use of a peripheral nerve stimulator is a recent approach."  Case reports, such as Upadhyay and Hassenbusch, also offer support for the use of peripheral nerve stimulator, but the overall experience is limited to a few hundred patients as opposed to several tens of thousands with SCS and is limited in its use in a single nerve setting.  Clinical practice guidelines support the use of SCS, but do not address the use of peripheral nerve stimulation.

Based on this review, peripheral nerve stimulation is not likely to be more beneficial than any of the standard treatments/procedures for this patient.

The carrier's denial of coverage for the peripheral electrical nerve stimulator should be upheld.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Lumbar Radicular Pain
Treatment: Lumbar Steroid Injections
The health plan denied the requested lumbar steroid injections. The health plan's determination is upheld.

The patient is a female with a history of spinal stenosis of the lumbar region with neurogenic claudication and lumbar radicular pain. There is no other clinical information submitted for review regarding the degree or duration of the complaints, therapies, medications, imaging, and the results of previous lumbar epidural/transforaminal steroid injections (ESI). Multiple medical societies endorse the use of ESI for relief of lumbar radicular symptoms. The clinical information submitted for review regarding the patient is limited.

The health plan's determination regarding the proposed health service or treatment is upheld, in whole.

No, the health service of Lumbar Epidural Steroid Injection is not likely to be more beneficial for the patient's condition.

Based on the literature, the standard of care for lumbar ESI is up to 3 injections per 12-month period. Some experts however recommend up to 6 ESI injections per 12-month period, although this would be decided on an individual basis. Many factors would be included in the decision making to extend the amount of injections beyond 3 per 12-month period. These would include the clinical response to the prior ESI (typically 50% reduction in radicular pain), the type and dose of corticosteroid used, the patient's comorbid conditions, the risk/benefit of other therapies including ablations or surgical therapy. Most physicians limit the number of injections to 3 in a 12-month period based on the potential for long term effects associated with corticosteroid use. Unfortunately, this has not been well studied. The literature is complete with adverse effects associated with ESI in general including due to just a single dose of corticosteroid. Without more information, it cannot be determined that the 4th ESI injection was clinically indicated.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Lumbar Radicular Pain
Treatment: Lumbar Steroid Injections
The health plan denied the requested lumbar steroid injections. The health plan's determination is upheld.

The patient is a female diagnosed with lumbar radicular pain. The patient received epidural steroid injections.

This reviewer upholds, in whole, the health plan's determination regarding the proposed health service or treatment.

The proposed health service or treatment lumbar epidural steroid injection (ESI) is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

In this case, there is no indication of pain improvement (a minimum of 50 to 70% pain relief) and improved function for at least 6 to 8 weeks as evidenced by documentation of decreased medication requirement.

All medical procedures and medications carry an inherent level of risk, that must be balanced with the effectiveness of the treatment to determine the risk to benefit ratio for a patient. Catastrophic complications of ESI such as paralysis and stroke unquestionably warrant the recent increased attention given to the safety of these injections. While a single major complication is unacceptable, the relative rate of these major complications must be put in perspective. The more common adverse events are rather minor, generally transient, and mostly occur at incidences of less than 1%.

A request for additional lumbar spine ESI in this patient with chronic radiculopathy requires additional documentation of recent symptom worsening associated with deterioration of neurologic state. In addition, the patient's ESI is indeed considered the fourth ESI in a row in a 12-month span. 

According to the Milliman Care Guidelines (MCG), epidural corticosteroid injection may be indicated when ALL of the following are present: Radicular pain, as indicated by 1 or more of the following: cervical radicular pain, lumbar radicular pain, failure of noninvasive treatment (e.g., nonsteroidal anti-inflammatory drug [NSAID], exercise, physical therapy, spinal manipulation therapy), goal of treatment is short-term relief of disabling pain. Signs or symptoms consistent with radiculopathy, as indicated by 1 or more of the following: diminished or absent deep tendon reflexes, paresthesias, numbness, sensory change, or weakness in dermatomal distribution, positive femoral nerve stretch test, positive Spurling test, positive straight leg raising test, no acute spinal cord compression, no coagulopathy or current use of anticoagulants or antiplatelet therapy, no local malignancy, no local or systemic infection.

For these reasons, the ESI is not considered more beneficial for this patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Axillary Hyperhidrosis
Treatment:  Botox injections x 4 visits 200 unit vial 
The insurer denied Botox injections x 4 visits 200 unit vial.
The determination is upheld.

This is a patient with axillary hyperhidrosis. The patient has reportedly tried and failed both topical Drysol and oral Oxybutynin. The clinic notes report that the patient has failed over-the-counter medication and an unspecified cream. The patient has been treated with Botox with positive results and significant improvement. The patient's sweating causes him to have severe anxiety and stress in public and work situations. The patient sweats through his clothes and frequently has to buy and replace outfits due to stained clothing. Botox treatment is under review for medical necessity.

Botox, as per the current standard of care [1-4] is medically necessary if there are functional and/or physical (not merely psychosocial) impacts caused by the hyperhidrosis. Such symptoms are not documented for this patient. Furthermore, there is a significant lack of documentation as to Drysol and/or Oxybutynin having been used with respect to duration of therapy and dosing of the oral Oxybutynin. As such, the long-term condition of hyperhidrosis is not being treated with first-line therapies that, even if Botox is used, remains appropriate supplemental treatment for this patient's particular clinical scenario.

The current medical literature [1-7] supports medical necessity only if first-line therapies have been exhausted, and such is not the case at this time. Botox is, based on this patient's clinical scenario, not medically necessary to treat this patient's axillary hyperhidrosis.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Dental Problems (skeletal Class I malocclusion, maxillary and mandibular crowding, excessive overjet, tongue thrust habit, and severe open bite). 
Treatment: D8080 Braces and D8670 monthly visits x 13. 

The insurer denied coverage for D8080 Braces and D8670 monthly visits x 13. 

The denial is overturned. 

This patient is a male child who presented for evaluation for orthodontic care. The orthodontist identified skeletal Class I malocclusion, maxillary and mandibular crowding, excessive overjet, tongue thrust habit, and severe open bite. The orthodontist has completed the Handicapping Labio-Lingual Deviation (HLD) index attaining 36 total points. The insurer has denied coverage for orthodontic treatment as not medically necessary, stating that the clinical circumstance does not meet the required handicapping malocclusion medical necessity requirements. 

Upon review of the submitted documentation (study models were not provided for review) 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, the HLD index is utilized. This index provides 6 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 does not claim an automatic qualifying condition and completes the second portion of the index arriving at 36 points to justify orthodontic care. This reviewer concurs with the index completed by this patient's orthodontist attaining a total of 36 points on the HLD index (5 overjet, 20 open bite, 10 anterior crowding, 1 labiolingual spread) which is above the threshold of 26 points to support orthodontic care. 

The coverage of D8080 braces and D8670 monthly visits x 13 is considered medically necessary for this patient. 

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

Based on the above, the medical necessity for D8080 Braces and D8670 monthly visits x 13 is substantiated. The insurer's denial should be overturned.