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

Diagnosis: Multiple Sclerosis
Issue Under Review: Functional electrical stimulator

Determination:
The Functional electrical stimulator is not medically necessary.

The patient is an adult male with multiple sclerosis (MS) and concomitant weakness of his left lower extremity. 

There are no high quality, large, randomized, prospective, controlled, long term clinical trials indicating that the surface electrical stimulation device improves outcomes, reverses disability, prevents falls or improve function outside of the laboratory setting for persons with multiple sclerosis compared to standard of care interventions.  There are no standard of care guidelines supporting the use of this system for this patient's condition.
Appeal type: Medical necessity
Decision: Upheld

Trauma/injuries
Inpatient hospital

Diagnosis: rib fractures
Treatment: Inpatient stay
The insurer denied the inpatient stay. The health plan's determination is upheld. 

The patient is a man who presented to the emergency department (ED) following a fall from an ATV (all-terrain vehicle) nearly 24 hours prior to his presentation. Comorbid health conditions included hypercholesterolemia. He was initially evaluated in the ED. Imaging with computed tomography (CT) scan diagnosed nondisplaced left rib fractures of ribs 8, 9, 10 and transverse process fractures of L1-4. At the time of presentation, he was awake and alert with a Glasgow coma score of 15. He was hemodynamically stable. Vital signs were normal.

The Inpatient care was not medically necessary for this patient. The care and treatment provided could have been rendered at a lower level of care. This patient presented to the ED nearly 24-hours following an accident in which he sustained 3 left rib fractures, and fractures of the transverse processes of L1-4. He was clinically stable at the time of presentation with normal vital signs and labs. He was able to ambulate and was able to tolerate a diet. He was provided a variety of different pain medications that included parenteral and oral narcotics, muscle relaxants, topical pain medications and anti-inflammatory medications. He remained clinically stable throughout the period of monitoring. A lower level of care would have provided for the care and treatment necessary for this patient.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Breast Cancer

Treatment: Proton Treatment delivery, simple, CPT Codes 77520

The insurer denied the Proton Treatment delivery, simple, CPT Codes 77520.

The denial was overturned.

The patient has a diagnosis of invasive ductal carcinoma (IDC) of the left breast.  She is status post neoadjuvant Adriamycin/Cytoxan followed by THP.  She had a lumpectomy and sentinel node biopsy.  Proton beam therapy is being requested to deliver adjuvant radiation therapy on National Cancer Institute approved RADCOMP trial.
	
According to Mihailidis DN.(2014), "Proton RT for postmastectomy RT is feasible and well tolerated.  This treatment may be warranted for selected patients with unfavorable cardiac anatomy, immediate reconstruction, or both that otherwise limits optimal RT delivery using standard methods."

Braunstein LZ & Cahlon O.,  "With advances in the overall treatment paradigm for breast cancer, most patients with localized disease now exhibit long-term disease control and, consequently, may manifest the late toxicities of aggressive treatment.  As a result, there is increasing emphasis on the mitigation of iatrogenic morbidity, with particular attention to heart and lung exposure in those receiving adjuvant radiotherapy.  Indeed, recent landmark analyses have demonstrated an increase in significant cardiac events that is linked directly to low-dose radiation to the heart.  Coupled with practice-changing trials that have expanded the indications for comprehensive regional nodal irradiation, there exists significant interest in employing novel technologies to mitigate cardiac dose while improving target volume coverage. Proton radiotherapy enjoys distinct physical advantages over photon-based approaches and, in appropriately selected patients, markedly improves both target coverage and normal tissue sparing." 

Orecchia R, et al. states, "Proton therapy is able to optimize the dose to the target and to reduce the irradiation of the healthy tissues.  Clinical studies are expected to show a decreased risk of late side effects with potential improvement of the quality of life of breast cancer patients."      

The Proton Treatment delivery, simple, CPT Codes 77520 is the best available treatment for this patient at this time.  Proton therapy is particularly beneficial for patients with tumors that are near critical structures, such as lung tumors near the heart.  The requested proton beam radiation therapy (RT) was provided as part of the National Cancer Institute (NCI) approved clinical trial (Phase III Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Non-Metastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial, ClinicalTrials.gov Identifier: NCT02603341).  Therefore, the requested proton beam RT is likely to be more beneficial than any other standard treatment/service.                                                      

The carrier's denial of coverage for Proton Treatment delivery, simple, CPT Codes 77520; date of service should be overturned.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Breast Cancer

Treatment: Proton Treatment delivery, simple, CPT Codes 77520

The insurer denied the Proton Treatment delivery, simple, CPT Codes 77520.

The denial was upheld.

This is a female patient with a history of breast cancer (triple positive cT1cN1 (llA) left invasive ductal carcinoma (IDC) status post neoadjuvant ac-THP and LLE+SLNB.  The initial office visit indicated the provider and the patient discussed the available options.  The patient chose to participate in a clinical trial involving proton beam therapy.  She signed the informed consent and she underwent treatment. 

Evaluate whether Proton Treatment delivery, simple, CPT Codes 77520; is considered more beneficial for this patient's diagnosis, addressing the following in your discussion: 

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome. Proton Treatment has final approval from the appropriate regulatory bodies.

This patient is not a good candidate for Proton Treatment. Proton Treatment is not the best available treatment for this patient at this time. The requested service is not likely to be more beneficial than any of the standard treatments/procedures for this patient.  Proton therapy is not recommended over photon therapy for breast cancer per National Comprehensive Cancer Network (NCCN).  In fact, proton therapy is not mentioned at all. There is a lack of literature to support proton beam therapy for the patient's condition over standard treatments such as photon therapy. The uncertainty regarding the relative value of proton vs photon is supported by the ongoing trial noted above "Because no one knows which radiation treatment is best, if you decide to take part in this study, you will be randomly assigned to 1 of 2 treatment groups, and then you will begin radiation treatment according to usual medical practice." Randomization is going until Aug 2022.

The carrier's denial of coverage for Proton Treatment delivery, simple, CPT Codes 77520; date of service should be upheld.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Breast Cancer

Treatment: Proton Treatment delivery, simple, CPT Codes 77520

The insurer denied the Proton Treatment delivery, simple, CPT Codes 77520.

The denial was overturned.

This case involves a female who has been diagnosed with malignant neoplasm of upper-outer quadrant of left female breast.  The documentation indicated she has a history of cT1 N1 M0 invasive ductal carcinoma of the left breast, ER/PR positive and HER-2 neu amplified.  She has undergone prior neoadjuvant Herceptin and Perjeta based chemotherapy followed by a lumpectomy with left axillary dissection.  Pathology then revealed ypT mic N1a M0 disease.  Two of ten axillary lymph nodes were positive.  She has been recommended to receive adjuvant radiation therapy to the left breast and regional lymph nodes and has been recommended for proton beam therapy based on a clinical trial.  The patient wanted to participate in a randomized comparative effectiveness study to compare proton therapy to photon therapy.

The scientific evidence in peer-reviewed literature supports a result of improvement in health outcome.

A recent systemic review included 13 trials.  They reported that proton therapy often decreased mean heart dose by a factor of 2 or 3, i.e. 1 Gy with proton therapy versus 3 Gy with conventional 3D, and 6 Gy for IMRT. Lungs were better spared with proton therapy than with photon therapy. (1)  A review of the literature shows showed a similar finding. (2)  A recent phase 2 trial showed Lower toxicities overall with the same cancer control rate, paving the way for randomized control trials such as the RADCOMP trial.

This patient is a good candidate for Proton Treatment delivery, simple, CPT Codes 77520. The dose volume histogram graphically shows the superiority of the proton plan complain to compare to the photon plan in sparing critical adjacent structures including the heart and lung.
Proton Treatment delivery, simple, CPT Codes 77520 is the best available treatment for this patient at this time, based on the literature and the dose volume histogram.

Proton therapy in this case is more beneficial than any of the other treatments including photon therapy.  This is clearly indicated in the dosimetric comparison of the 2 techniques.  Even if a much better photon plan were able to be achieved, reducing the mean heart dose to 4 or 5 Gy, there is significant benefit to reducing the heart dose to less than 1 Gy as was done with the proton plan.  This significantly lowers the risk of radiation induced heart disease later in life.

The carrier's denial of coverage for Proton Treatment delivery, simple, CPT Codes 77520; date of service should be overturned.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Gastroparesis.
Treatment: Motegrity.
The insurer denied the Motegrity.
The denial is overturned. 

The patient is a female with gastroparesis. She has failed treatment with Domperidone after not tolerating Reglan. She has frequent emergency room (ER) visits for vomiting, dehydration and electrolyte abnormalities. The medical doctor (MD) is requesting treatment with Motegrity. 

Yes, the proposed Motegrity is medically necessary.  

The patient has gastroparesis and is unable to tolerate Reglan and has failed treatment with Domperidone.  Carbone showed that Motegrity significantly improved the overall Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life score (1.15  0.16 versus 1.44  0.16, P < 0.05) and the domains of clothing and diet. The gastric half emptying time was significantly enhanced by Motegrity compared with placebo. As the patient has failed all therapy for gastroparesis, has intractable vomiting with ER visits for vomiting, dehydration and electrolyte abnormalities, and as there is medical literature to support the use of Motegrity for the treatment of gastroparesis, and no other therapeutic treatment options, the proposed Motegrity is medically necessary, and the health plan act did not reasonably, with sound medical judgment and in the best interest of the patient by denying it.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Tuberous sclerosis
Treatment: Epidiolex
The insurer denied Epidiolex.
The determination is upheld.

This is a patient  with tuberous sclerosis. As a consequence of his tuberous sclerosis, he has epileptic seizures. The seizures are focal in onset and consist of behavioral arrest, eye twitching and hand twitching and have a duration of 10-20 seconds. Despite treatment with levetiracetam and Onfi, he has continued to have multiple seizures per day. In an attempt to better control the seizures, his neurologist has prescribed Epidiolex (cannabidiol). At issue is the medical necessity of the Epidiolex.
The use of Epidiolex for the treatment of seizures due to tuberous sclerosis is not medically necessary. This is a patient who has epileptic seizures secondary to tuberous sclerosis. Tuberous sclerosis is an autosomal dominantly-inherited disorder that affects many organ systems through abnormalities in growth and differentiation of tissues. In the central nervous system, tuberous sclerosis often leads to cortical tubers and epilepsy. The epileptic seizures of tuberous sclerosis are often refractory to medical treatment. Epidiolex (cannabidiol) is a compound derived from the marijuana plant that has anti-epileptic properties in some forms of seizure disorder. In particular, Epidiolex has been shown to be effective as an anticonvulsant in Lennox-Gastaut Syndrome and in Dravet Syndrome, which are both epileptic encephalopathies. While Epidiolex is effective against some seizure types, it is not known to be effective against the seizures of tuberous sclerosis. There have been no double-blind placebo-controlled studies published demonstrating the efficacy of Epidiolex against the seizures of tuberous sclerosis. It is not considered standard of care and is not medically necessary for the treatment of this patient's seizures.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Major depressive disorder
Treatment: Outpatient mental health treatment
The insurer denied the outpatient mental health treatment.
The denial is upheld.

The patient is a woman with a history of mental illness who received psychiatric treatment.

The patient has been diagnosed with major depressive disorder, recurrent, in partial remission.  She is in treatment with a certified psychologist.  They are engaged in therapy three times per week for 50-minute treatment sessions.

No, the Outpatient Mental Health Treatment was not medically necessary.

There is no documentation suggesting that multiple treatments per week for multiple months were medically necessary.  There is no suggestion of any acute risk factors of dangerous behaviors and there is no evidence that withholding this treatment would have resulted in an adverse outcome such as suicide, violence, or psychiatric hospitalization.

Treatment was not sufficiently documented to confirm the treatment as medically necessary.  Furthermore, the treatment provided was 50-minute therapy sessions.  The treatment was billed as 60-minute sessions.  Therefore, an improper billing code was used and treatment should not be covered by the health plan based on this fact.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Abscess
Treatment: Inpatient admission 
The insurer is denied coverage for the inpatient admission.
The denial is upheld.

This is a female patient who presented to the Emergency Department (ED) after a history of worsening left buttock redness, pain and swelling. She had needle drainage of a small abscess by her pediatrician three days prior to presentation.  Wound culture from that drainage yielded Methicillin Resistant Staphylococcus aureus (MRSA). Her presenting vital signs were: temperature of 98.1 to 100.3F, heart rate of 112-145 beats per minute, respiratory rate of 24-50 breaths per minute, and blood pressures within normal range. A physical examination was done that revealed a 3 cm x 4 cm left gluteal redness and induration with an area of fluctuance. There was a slightly elevated white blood cell (WBC) count of 15.4 with normal differential counts, and a slightly elevated anion gap of 15. Surgery was consulted. The patient's diagnosis was abscess. A bedside Incision & Drainage (I&D) was performed by Surgery in the ED, with 15 ml pus drained. She received intravenous (IV) fluids and IV antibiotics. She was discharged with follow up instructions.

Based on the review of the medical record and literature, the definitive treatment of this
Patient's abscess, which was less than 5 cm in diameter, was incision and drainage. Parenteral antibiotics were not necessary because the patient did not present with any clinical signs of sepsis and the likelihood of bacteremia was extremely small.1 Moreover, the organism was susceptible to clindamycin, and so it was not necessary to administer vancomycin. The patient's lack of improvement was not a failure of outpatient antibiotic therapy, but because only a needle drainage was done in the office. The patient needed an incision and drainage for her abscess, which was done in the Emergency Department (ED). The patient was safe to be discharged after the procedure from the ED, and follow up with her pediatrician as outpatient. The inpatient admission was not medically necessary.

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

The carrier's denial of coverage for the inpatient admission should be upheld. The medical necessity is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chronic Lymphocytic Leukemia
Treatment: Imbruvica 140 MG OR TABS
The insurer denied the Imbruvica 140 MG OR TABS.
The denial is upheld. 

The patient is a female with chronic lymphocytic leukemia. Cytogenetics included del(11q). The patient was stage II at presentation. 

The patient was started on treatment with Imbruvica (ibrutinib) tablets at a dose of 420 milligrams (MG) daily and was decreased to a dose of 280 MG daily and then further decreased to 140 MG daily. The medical records indicate the patient is unable to take large pills. 

No, the proposed treatment with Imbruvica 140 MG OR TABS is not medically necessary.

The proposed treatment is continuation of treatment with ibrutinib 140 MG tablet per day. The health plan will only cover ibrutinib 140 MG capsule per day. 

Medically, the two formulations are biologically identical. The National Comprehensive Cancer Network (NCCN) Guidelines do not distinguish between capsule and tablet formulations of ibrutinib (1). The trials of ibrutinib did not distinguish between capsules and tablets (2, 3, 4). There is no documentation that any size difference between the capsule and tablet formulation would impact the ability of the patient to swallow the pill.

As the patient has not tried and failed treatment with ibrutinib capsules, and the tablet and capsule forms of ibrutinib are medically identical, treatment with the tablet form would not be medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Foot Disorder
Orthotics (Shoe Inserts)

Diagnosis: Flatfeet
Treatment: custom shoe inserts
The insurer denied custom shoe inserts. The health plan's determination is overturned. 

The patient is a male who presented complaining of flatfeet. He has custom orthotics, but states they are worn out. He also complains of pain in both knees with prolonged standing and walking. On examination, there is excessive pronation noted during gait as well as bilateral pes planus. The patient's current orthotics were noted to be excessively worn.

The custom shoe inserts are medically necessary for this patient. He complains of pain in both knees with prolonged standing and walking. Custom orthotics are considered standard therapy for symptomatic flatfoot. While the literature clearly lacks rigorous comparative studies for each intervention, the patient has already been treated with custom orthotics and they have proven to be effective for him. Therefore, it would be unreasonable to recommend for the patient to return to pre-fabricated devices or other treatment modalities.
Appeal type: Experimental/Investigational
Decision: Upheld

Reviewer #3:

This is a female patient with a history of a right sided meniscal repair. She reported having left knee pain for several months. She had been treated with cortisone and physical therapy. Imaging studies revealed minimal degenerative changes with chondral impaction with subchondral edema and a fluid filled cavity in area of medial tibial plateau.  Her treating physician performed arthroscopic surgery (menisectomies) and subchondroplasty of medial plateau. 

The scientific evidence in peer-reviewed literature supports a result of improvement in health outcome. A search was performed using Pub Med (National Library of Medicine).  The key word was subchondroplasty and knee. References reported overall net benefit but the number of patients evaluated was not extensive. There were associated complications but nevertheless improvement was reported in approximately 70-80%.  The goal was to relieve pain and avoid knee replacement.   (See reference 1) Approval from FDA has been provided for marketing and use of subchondroplasty. 

This patient is a good candidate for a knee sub chondroplasty for a meniscus tear. The records demonstrate consistency of complaint, physical findings and imaging for the bone marrow edema and lesion.  There has been a course of conservative treatment provided.  A pain generator has been defined.  There is a cystic lesion which is unusual.  The patient does not have isolated bone marrow edema.  Her indications for the subchondroplasty would be extended due to the defect in bone (cystic lesion).The woman underwent the subchondroplasty due to the cystic lesion, not her meniscal tear. 

The requested service is more likely to be more beneficial than any of the standard procedures for this patient i.e. there was a bone defect which requires stabilization. 

The carrier's denial of coverage for the services described by codes(s) 27599 and 29880-LT performed should be reversed.
Appeal type: Experimental/Investigational
Decision: Upheld

Reviewer #2:

This is a female patient with a history of left knee pain for several months. The patient had cortisone injections and physical therapy with no relief to her symptoms. A magnetic resonance imaging (MRI) was performed that revealed a medial and lateral meniscus tear, minimal degenerative changes, some chondral impaction with cystic change, and a fluid-filled cavity in the subchondral edema of the medial tibial plateau. The recommended treatment was a medial and lateral meniscus tear, minimal degenerative changes, some chondral impaction with cystic change, and a fluid-filled cavity in the subchondral edema of the medial tibial plateau.

Current literature indicates surgical intervention is appropriate for a patient when there is a need for evaluation or treatment for intra-articular joint pathology such as mechanical symptoms.  The literature noted that surgical options for a meniscal tear include partial or total meniscectomy and repair of the meniscal tear.  The sub chondroplasty is effective and improves quality of life for patients with bone marrow lesions and knee osteoarthritis. The notes indicate that the patient's symptoms have been ongoing and long-standing. According to the imaging review, the patient's symptoms are predominantly degenerative in nature.  Knee arthroscopic procedures in patients who have advanced degenerative changes do not allow significant resolution or long-term improvement in symptoms.  Furthermore, a chondroplasty is indicated for focal lesions; however, in the current clinical scenario the patient was noted to have diffuse cartilage injury.  For these reasons the requested surgical procedure cannot be approved.  The requested services are not likely to be more beneficial than any standard treatment/procedures for this patient.

The carrier's denial of coverage for the services described by codes(s) 27599 and 29880-LT performed should be upheld.