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

Diagnosis:  Uterine fibroids.
Treatment:  Laparoscopic hysterectomy at an outpatient level of care.

The insurer denied coverage for laparoscopic hysterectomy at an outpatient level of care.  The denial is overturned.

The patient is an adult with chief complaint of menorrhagia, dyspareunia and dysmenorrhea. She was diagnosed with uterine fibroids. Ultrasound showed a submucosal myoma measuring 3 centimeters (cm). The endometrium was very thickened at 19 millimeters (mm). Endometrial biopsy showed proliferative endometrium. Her hematocrit was 37.4. The note stated that the patient wants to try hysteroscopic resection and Nova sure Ablation. However, the request is for a laparoscopic hysterectomy.

This patient has a complaint of menorrhagia, dyspareunia and dysmenorrhea. She has a benign endometrial biopsy. Ultrasound and Sono hysterogram showed an intramural myoma that is protruding inside the endometrial cavity.

The only treatment for this patient is surgical. Medical treatments (hormone, Lenorgestrel intrauterine device (IUD) Tranexamic acid) will not be able to help with a fibroid that is protruding inside the endometrial cavity. Based on the submitted report and the pictures submitted, a hysteroscopic resection will be inadequate to remove the fibroid. It will only remove the part that is protruding inside the cavity and the remaining part of the fibroid will regrow fast.  There are only 2 options: a laparoscopic myomectomy if the patient is still interested in childbearing or a hysterectomy if the patient is interested in definitive treatment.

Based on the above, the insurer's denial must be reversed. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for laparoscopic hysterectomy at an outpatient level of care is substantiated.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low Back Pain
Treatment: Intracept Procedure
The insurer denied the Intracept Procedure.
The determination is overturned.

This is a male patient with a history of low back pain. His pain is dull and achy, aggravated by prolonged sitting, standing and forward bending. He had previously undergone chiropractic manipulation, home exercise, lumbar discectomy and lumbar epidural steroid injection, but none of these treatments provided sustained pain relief. His pain level is 5/10. This pain has a significant impact on his activities of daily living (ADLs) including sitting, standing and walking. Magnetic resonance imaging (MRI) revealed multilevel degenerative disc disease with Modic changes in the lumbar (L) 4, L5, and sacral (S) 1 vertebral bodies. On physical exam (PE), there was tenderness in the lumbar paraspinal regions, decreased lumbar flexion and extension.
At issue is whether the proposed health service or treatment, Intracept procedure, is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

The proposed health service or treatment, Intracept procedure, is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
The Intracept system was designed to treat low back pain from the vertebral body by ablating basivertebral nerves. There are multiple clinical trials demonstrating the sustained improvements in pain and function of this intervention for patients with vertebrogenic pain. This patient had failed extensive treatments including chiropractic manipulation, home exercise, lumbar discectomy and lumbar epidural steroid injection. His pain is severe enough with a negative impact on his ADLs (activities of daily living). Further interventions are necessary to improve his pain and function. Other potential treatment options are long-term use of medications (non-steroidal anti-inflammatory drugs (NSAIDs), opioids) and lumbar decompression fusion surgery. However, none of these options has a high success rate, and all of them carry significant risks and complications. Given this clinical scenario, the Intracept procedure is likely to be more beneficial than any standard treatments for the insured's disabling condition.
From reviewing the medical records and current clinical studies, this patient has persistent symptoms consistent with vertebrogenic pain. His pain is severe enough with negative impact on his ADLs (activities of daily living). An MRI (Magnetic resonance imaging) revealed finding of Modic changes at L (lumbar) 4 L5 and S (sacral) 1 level of his lumbar spine. The Intracept procedure is an appropriate intervention as the next step intervention.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Decay/Cavities
Treatment: Porcelain 4 Surface Onlay on tooth 13
The health plan denied: Porcelain 4 Surface Onlay on tooth 13
The determination is: Overturned

The patient is a male with recurrent decay on tooth #13. He presented for restoration of tooth #13. It has existing resin filling, and proposed treatment is a 4-surface porcelain onlay. Additional radiographic images were provided on request and demonstrate recurrent decay.

At issue is the medical necessity of the porcelain 4 surface onlay on tooth #13.

The health plan's determination of medical necessity is overturned in whole.

Yes, the requested health service/treatment of porcelain 4 surface onlay on tooth 13 is medically necessary for this patient. This is the ideal treatment for this tooth given the location and extent of decay. A direct restoration is not recommended and would have a questionable long-term prognosis. The porcelain onlay on tooth #13 is needed to address the decay as noted by radiographic evidence. Furthermore, the location and extent of decay will have a guarded prognosis with a direct restoration, and an indirect restoration will provide better coverage, marginal adaptability, and long-term prognosis.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Osteoporosis 
Treatment: Formulary exception for Evenity
The insurer denied the formulary exception for Evenity. 
The denial is upheld. 

The health plan should not cover the proposed treatment.

This patient is a female with history of severe osteoporosis.  The patient has a bone density scan showing a lumbar spine T-score (the number of standard deviations that your bone density is above or below the average) of -4.3.  The request for Evenity was initially denied due to the patient not having tried and failed formulary alternatives Forteo, Tymlos and Prolia.  The reason the provider is appealing the determination is because the provider feels that Evenity is the best option for this patient.

The patient has severe osteoporosis.  The patient has a T-score of the lumbar spine of -4.3.  The patient has not tried and failed formulary alternatives Forteo, Tymlos or Prolia.  There are no clinical studies indicating that Evenity would be far superior to the formulary alternatives.  There are no clinical studies indicating that Evenity would be safer for this patient than the formulary alternatives.  Therefore, the health plan should not cover the proposed treatment.
Appeal type: Medical necessity
Decision: Upheld

Endocrine/Metabolic/Nutritional
Durable Medical Equipment

Diagnosis: Type 2 Diabetes
Treatment: Dexcom G7 continuous glucose monitor
The insurer denied Dexcom G7 continuous glucose monitor.
The determination is upheld.

This is a male patient with type 2 diabetes who is 92 percent (%) of the time in range on Jardiance alone. The medical necessity for Dexcom G7 continuous glucose monitor is under review.

The requested Dexcom G7 CGM was not medically necessary.
This request is for Dexcom G7 sensor for the management of type 2 diabetes. The submitted progress note indicates that the patient has well controlled type 2 diabetes on Jardiance alone. The patient is not on insulin therapy. Continuous glucose monitoring has been shown to be safe and effective for people with uncontrolled type 2 diabetes on basal insulin or multiple daily insulin injections, which is not documented in this case. There is insufficient evidence to support the use of Dexcom G7 sensor in this clinical situation. Therefore, the requested Dexcom G7 sensor is not medically necessary for this patient.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Breast cancer.
Treatment:  Proton beam therapy.

The insurer denied proton beam therapy.  The health plan's determination is overturned. 

This is the case of a female patient who underwent a bilateral mastectomy. The patient then developed recurrence and underwent a lumpectomy. The plan is to treat R (right) chest wall and nodal area with radiation therapy (RT) using proton beam therapy (PBT). This is the subject of review.

The requested Proton Beam Radiation Therapy (PBRT) is medically necessary for this patient. The AP (attending provider) provided DVH (dose volume histogram) comparison of proton and photon treatment. Proton beam therapy delivers V5 41% compared to 100% by photons. Photon beam therapy delivers V20 14% compared to 80% by photons.

Proton beam therapy delivers a mean heart dose of 0.26 Gy (gray unit) compared to 13 gy by photons. All these are Quantec deviations and are not acceptable.

This is a young patient with curative disease and proton beam therapy (PBT) will avoid morbidities and mortality in this young patient. Thus, the requested PBT is medically necessary and appropriate in this patient.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Rheumatoid arthritis
Treatment is Orencia SQ (subcutaneous) 125 mg (milligrams)  
The insurer denied coverage for Orencia SQ 125 mg
The denial is overturned.

The patient is an adult female with a diagnosis of rheumatoid arthritis with a positive rheumatoid factor. The patient has morning stiffness and severe joint pain. The patient has active, poly articular small joint arthritis. The patient had been started on Humira for many years. The patient trialed and failed methotrexate, Enbrel, Xeljanz, Humira, and Cimzia. The patient was on and off Humira. Humira was stopped because of progression of her disease. The treating provider, is requesting plan approval for Orencia, which is under medical necessity review.

The issue of hyperlipidemia has been raised by the provider. The patient has been on Lipitor for hyperlipidemia. The Food and Drug Administration (FDA) insert for Kevzara notes an increase in LDL (low-density lipoprotein) of 12-16 based on dose and an increase of TG (triglycerides) of 20-27 based on the dose. Orencia as per the FDA is not associated with any adverse lipid effects. Orencia SQ 125 mg is thus considered medically necessary for this patient. 

"Rheumatoid arthritis (RA) is a complex disease in which different mechanisms are involved. Studies suggest a key role for aberrant pathways of T-cell activation in the initiation and perpetuation of disease. Abatacept is a fusion protein composed of the Fc (fragment crystallizable) region of the immunoglobulin G1 (IgG1) fused to the extracellular domain of cytotoxic T (thymus) lymphocyte-associated antigen (CTLA4). It has the ability to modulate T-cell activation by interfering with co-stimulation of these cells, a necessary step to become activated. This suggests that abatacept may play a role in the progression and/or even the initiation of RA. Areas covered: a review of the different studies carried out during clinical development of abatacept was performed. Both formulations, intravenous (IV) and subcutaneous (SC), showed a similar and consistent efficacy and safety profile. Abatacept was effective both in RA patients not responding to methotrexate (MTX) and to tumor necrosis factor (TNF) inhibitors. Expert commentary: abatacept, with its unique mechanism of action, proved to be a useful therapeutic alternative in RA, also having an acceptable safety profile. Evidence points out that abatacept may be able to alter the RA disease course." (Pombo-Suarez, M., & Gomez-Reino, J. J. 2019).

Indications and Usage: "ORENCIA is a selective T cell costimulation modulator indicated for: Adult Rheumatoid Arthritis (RA) moderately to severely active RA in adults. ORENCIA may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists." (Orencia, 2022).           

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for Orencia SQ 125 mg services is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Cancer of the Sternum
Treatment: Radiation Therapy/Proton Beam Radiation Therapy (PBRT)
The health plan denied the requested Proton Beam Radiation Therapy (PBRT) as not medically necessary.
The health plan's determination is overturned.

This is a female with a history of recurrent thyroid cancer involving her sternal region, status post resection. She has been recommended to proceed with a course of postoperative radiation to minimize her risk for recurrence.

At issue is the medical necessity for the requested Proton Beam Radiation Therapy (PBRT).

I recommend overturning the health plan's determination, in whole.

The requested proton radiation is medically necessary and standard of care in the patient's situation.

The treating provider supplied a proton/photon plan comparison which shows that photon-based radiation is unable to provide adequate safety/precision with regard to normal tissue avoidance. The photon radiation plan could not protect the patient's heart, trachea, and brachial plexus. If delivered, the photon-based plan would result in an unacceptable and unnecessary risk for serious toxicity, including cardiac morbidity/mortality. The proton radiation plan was able to significantly minimize the exposure to the patient's critical normal tissues, thereby limiting the risk for high grade morbidity. Proton radiation is supported by the ASTRO (American Society for Radiation Oncology) Model Policy for patients in whom photon radiation cannot meet nationally accepted treatment planning objectives.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Chronic low back pain
Treatment: outpatient basivertebral nerve ablation procedure (The Intracept System) - Procedure code 64623
The insurer denied coverage for outpatient basivertebral nerve ablation procedure (The Intracept System) - Procedure code 64623
The denial is upheld

This patient has chronic low back pain. He has had Physical Therapy and a Home exercise program. He has had Epidural steroid injections. His medication trials have included Tylenol, Cyclobenzaprine, Valium, Diclofenac, Ibuprofen, Oxycodone, and Prednisone. He has had prior back surgery and has used a back brace. His magnetic resonance imaging (MRI) shows lumbar (L)3-L4 disc protrusion and annular fissure. It also shows Modic changes at L3 and L4. The request is for radiofrequency ablation (RFA) of the basivertebral nerve at L3 and L4.

The publications to date have been company sponsored and had methodology flaws. There is 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 (and others) 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 basivertebral nerve (BVN). Non-industry funded high-quality, large prospective studies are needed to confirm these findings."
      
Urits et al also commented on the need for more research on this promising technique: "Reproducible large randomized controlled trials (RCTs) are still needed for clinicians to gain full confidence in utilizing this treatment in practice. Additionally, further research is needed on the anatomy of the vertebrae to optimize the method of treatment. These studies can help to elucidate the role of RF (radiofrequency) ablation in the management of chronic low back pain (cLBP) and improve the quality of life of CLBP patients in the near future."

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

In summary, the denial of outpatient basivertebral nerve ablation procedure (The Intracept System) - Procedure code 64623 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 risks are substantially increased over standard treatments.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Cerebellar ataxia
Treatment: Home modification (tub to shower) services
The insurer denied coverage for home modification (tub to shower) services.
The denial is upheld.

This is an adult with cerebellar ataxia and balance deficits. Recent treatment included physical therapy. Currently under review is the request for a home modification (tub to shower).

The clinical records do not support the medical necessity for a home modification (tub to shower). According to the physical therapist, the patient requires moderate assistance for transfer tasks. There are grab bars available for added safety for transferring in and out of the tub. In addition, the patient has a personal care assistant (PCA) 7 days/week, 10 hours/day (total 70 hours/week) for support with locomotion (including transfers), bathing, and hygiene. The combination of the physical therapy, home safety features (grab bars), and availability of the PCA are clinically appropriate and more than sufficient for safety and accessibility, rendering the home modification (tub to shower) as not medically necessary. 

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably, with sound medical judgment, and in the best interest of the patient. The medical necessity for home modification (tub to shower) services is not substantiated.
Appeal type: Medical necessity
Decision: Overturned


Diagnosis: Filamentary keratitis of right eye, and keratoconus of both eyes

Treatment: Acthar gel 80 unit/ml (milliliter)

The insurer denied coverage for Acthar gel 80 unit/ml

The denial is overturned

The patient has a history of keratoconus and history of corneal transplant.  Patient also has filamentary keratitis which can deteriorate the cornea and cause a corneal graft rejection.  Patient has not shown improvement with other treatments including Restasis.  Because patient has shown improvement with Acthar, this medication is medically necessary for the patient to prevent corneal deterioration and potential visual complications.

The requested Acthar Gel (repository corticotropin) is medically necessary for this patient.  Conventional treatment for this patient has been ineffective, including use of steroids and Restasis.  Because of this, Acthar Gel is one of the limited remaining options for the treatment of this patient's condition and prevent permanent vision loss.

Acthar was approved by the Food and Drug Administration (FDA) in 1952 for the treatment of various inflammatory conditions, which would include a condition such as filamentary keratitis and/or corneal graft failure.   Acthar Gel (repository corticotropin injection) is FDA- approved for various acute and chronic inflammatory ophthalmic conditions.  There are a few published studies about the drug's clinical efficacy in the treatment of uveitis.  A case report described the successful use of Acthar in the management of a patient with panuveitis and retinal vasculitis (Agarwal et al. 2016).  Another case reported the successful use of Acthar is a 16 year-old girl with refractory uveitis secondary to juvenile idiopathic arthritis (Ahmad et al. 2016).  A study examined 47 patients with advanced pulmonary sarcoidosis treated with Acthar (Baughman 2016).  Seven patients had ocular involvement, for which three patients completed a full course of treatment.  Two patients showed an improvement in their uveitis, and one remained stable.  The drug shows early promise in these small clinical series, and it is acknowledged that additional data is needed before routine use of this class of drug is recommended for treatment of uveitis.  However, in specific cases such as this where the patient has had ineffectiveness to standard treatments, Acthar gel is medically necessary to prevent potential visual compromise and vision loss.

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Acthar gel 80 unit/ml (milliliter) services is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: central nervous system (CNS) lymphoma
Treatment: inpatient hospital admission 
The insurer denied inpatient hospital admission. 
The health plan's determination is overturned. 

This is patient with diagnosis of human immunodeficiency virus (HIV) infection, central nervous system (CNS) lymphoma (diffuse large B cell), status post high dose methotrexate, followed by R-VP (rituximab, cyclophosphamide, vincristine, prednisone) regimen and high dose therapy with autologous stem cell transplantation. The patient was found to have persistent CMV (Cytomegalovirus) viremia with rising level of viral load and developing thrombocytopenia while on Valcyte. He was hospitalized for intravenous (iv) foscarnet induction therapy. 

An inpatient hospital admission was medically necessary.
CMV (Cytomegalovirus viremia) infection is a life threatening condition in a patient with immunocompromised state such as bone marrow transplantation. Foscarnet is FDA approved antiviral therapy for CMV infection. Trials with intravenous foscarnet in CMV infections have reported favorable results using initial daily doses of 180-230 mg/kg/d (milligrams/kilogram/day) given as intermittent infusions every eight hours, followed by maintenance regimens of 60-90 mg/kg/d given as single daily one- or two-hour infusions. Foscarnet therapy may result in renal impairment, and indefinite intravenous maintenance therapy may be required to prevent recurrence of CMV infection. Foscarent is administered in the hospital setting due to the need for IV therapy and close clinical monitoring and management of toxicities.