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

Diagnosis: Malignant Neoplasm, Prostate

Treatment proton beam therapy (PBT)

The insurer denied coverage for proton beam therapy (PBT)

The denial is upheld

This is a patient with a history of malignant neoplasm of the prostate. He presented to the Radiation Oncologist's office for an evaluation of prostate cancer. The physician noted that the patient had favorable intermediate risk adenocarcinoma of the prostate. He recommended definitive proton therapy.  

Proton beam therapy (PBT) is not considered medically necessary for this patient. Proton radiation is not proven to yield superior clinical outcomes in the patient's situation compared to standard of care treatments. Proton radiation is not supported by the American Society of Radiation Oncologists (ASTRO) Model Policy in the claimant's setting outside the context of a clinical trial.

Moon, D. H., Efstathiou, J. A., & Chen, R. C. (2017), "Today, intensity-modulated RT [radiation therapy] IMRT [intensity-modulated radiation therapy] is considered standard, where radiation beams of different shapes and intensities can be delivered from a wide range of angles, thus further decreasing doses to normal organs and likely reducing treatment-related toxicity. In addition, image guidance ascertains the location of the prostate before daily treatment delivery. Brachytherapy is the placement of radioactive seeds directly in the prostate, and has a long track record as a monotherapy for low-risk prostate cancer patients with excellent long-term cancer control and quality of life outcomes. Recent studies including several randomized trials support the use of brachytherapy in combination with external beam RT for higher-risk patients. RT for prostate cancer continues to evolve. Proton therapy has a theoretical advantage over photons as it deposits most of the dose at a prescribed depth with a rapid dose fall-off thereafter; therefore it reduces some doses delivered to the bladder and rectum. Prospective studies have shown the safety and efficacy of proton therapy for prostate cancer, but whether it leads to improved patient outcomes compared to IMRT is unknown."

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

The insurer's denial of coverage for proton beam therapy (PBT) is upheld. Medical Necessity is not substantiated.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: desmoid fibromatosis 
Treatment: Nexavar
The insurer denied Nexavar. 
The health plan's determination is overturned.

The patient is a male with a history of a left cheek and neck mass that was biopsied and found to be desmoid fibromatosis. The mass is not resectable due to its location close to the carotid artery and multiple nerves. The child is at risk for extension of the mass with blockage of the arteries or nerve damage. There are limited treatment options for the child at this time. The provider states that intravenous (IV) chemotherapy could be used (including vinblastine, methotrexate), which would require placement of a portacath and would cause significant immune suppression and low blood counts. Due to these concerns, the provider has recommended sorafenib (Nexavar) as treatment of his condition. The use of Nexavar is under review.

Nexavar is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

As per an international prospective phase III double-blind study, the efficacy of sorafenib in patients with unresectable progressive or symptomatic tumors showed an objective response rate of 33% in the sorafenib arm versus (vs). 20% in the placebo arm, and a 2-year progression free survival rate of 81% vs. 36% when looking at sorafenib vs. placebo. While this study focused on adult patients, it is still considered in the standard of care treatment options for pediatric patients specifically with a level of evidence of 1, even when discussing younger patients. A more recent review of this treatment by Sparber-Sauer et al noted that tyrosine kinase inhibitors (TKIs) such as Nexavar show better efficacy than vinblastine and methotrexate and that the short-term side effects are well tolerated.
Given the limited treatment options for this particular patient with the location of the desmoid-like tumor and the fact that the use of Nexavar is considered a standard of care per the NCI, the use of this treatment is likely to be more beneficial than other treatment options.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: desmoid fibromatosis 
Treatment: Nexavar
The insurer denied Nexavar. 
The health plan's determination is overturned.

The patient under review is a male who presented with a several month history of progressive left facial swelling. Imaging revealed a large 7 x 4 centimeter (cm) mass in the left deep parotid and masticator spaces bulging into the left carotid space, with posterior displacement of the left carotid artery and compression of the left internal jugular vein. Biopsy of the mass was performed and pathology resulted as a Desmoid Fibromatosis with a CTNNB1 (Catenin Beta 1) mutation on genomic sequencing. The mass was deemed unresectable due to high risk for neurovascular compromise which could compromise breathing, swallowing, and increase risk for stroke. The mass has been noted to be growing and therefore systemic therapy has been recommended. There is no standard of care for systemic treatment of desmoid fibromatosis in children but options include systemic intravenous chemotherapy (methotrexate and vinblastine) and oral tyrosine kinase therapy (sorafenib). Given the risks and benefits of the various options, the patient's oncologist is recommending oral sorafenib (Nexavar) as first line therapy.

Nexavar is 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, the tumor was deemed unresectable due to the location and high risk for surgical complications and resultant serious morbidity. Therefore, systemic therapy is indicated for this young child. While there is no established standard of care for systemic therapy for desmoid fibromatosis, there are several effective approaches, including systemic intravenous chemotherapy (methotrexate and vinblastine) and the oral multi-targeted tyrosine kinase inhibitor, sorafenib. The benefit of sorafenib over intravenous chemotherapy is that it is taken orally and had a tolerable side effect profile, while IV chemotherapy requires surgical placement of a mediport for administration, frequent office visits for treatments, and harbors an increased risk for infection due to myelosuppression as well as other toxicities including hepatotoxicity, mucositis, and neuropathy. In a landmark double-blinded randomized Phase III trial, sorafenib was shown to have a statistically significant improved progression-free survival as compared to placebo in patients with progressive, refractory, or symptomatic desmoid tumors. Sorafenib has undergone Phase I and II testing in children showing that it is safe and tolerable at BSA (body surface area)-based doing with a similar side effect profile as adults. Based on this data, sorafenib (Nexavar) would likely be more beneficial for this patient than intravenous (IV) systemic chemotherapy due to equal efficacy with improved quality of life and decreased potential risks and side effects.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: desmoid fibromatosis 
Treatment: Nexavar
The insurer denied Nexavar. 
The health plan's determination is overturned.

The patient is a  boy who was diagnosed with desmoid fibromatosis of the left cheek and neck. The mass was biopsied confirming the diagnosis. A computed tomography (CT) of the neck showed a large heterogeneously enhancing well-circumscribed mass in the left masticator and submandibular spaces extending to the anterior left carotid space extension into the left submandibular space superiorly to the inferior margin of the left temporal bone and to the inferior portion of the soft tissues of the left external auditory canal, and inferiorly to the level of the epiglottis. It measures 4.9 centimeter (cm) x 5.2 cm x 5.0 cm. An magnetic resonance imaging (MRI) was performed which demonstrate the mass, but also show several enlarged lymph nodes in bilateral neck. The tumor extends on the carotid artery and is situated near facial nerves. This tumor is not surgically resectable at this time. The tumor has continued to grow over the past several months potentially posing a risk to his swallowing, breathing and nerve damage.
Under review is the use of Nexavar to treat this tumor.

Nexavar is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. Desmoid fibromatosis tumors can be aggressive and occur in both children and adults. They are usually localized tumors arising from mesenchymal tissues. They can be infiltrative which can make resection challenging. There is no standard of care for management or treatment of these tumors. Molecular and genetic studies have provided insight into new therapies including TKI (Tyrosine kinase inhibitors) drugs.  The available clinical trial results in adults as well as case reports in children strongly support the use of sorafenib in upfront treatment in children whose tumors are unresectable. It is indicated in this patient with a very large and unresectable face and neck tumor which poses significant risk for his functioning and survival. There is scientific controlled trial data and results in adults to support its use and efficacy as well as multiple case reports in pediatrics also supporting its efficacy and safety.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Central Nervous System/Neuromuscular Disorder. 
Treatment: Home Health Care. 
The insurer denied increase in personal care worker (PCW) services to 12 hours a day 7 days a week for 84 hours a week. 
The denial is upheld.

The patient is a female with past medical history significant for Parkinson's disease, bladder cancer, gait dysfunction and dementia.
The patient is currently approved for 11 hours a day 7 days a week for a total of 77 hours a week, this is a reduction in hours from 12 hours per day 7 days per week for a total for 84 hours per week. Increased services were denied based on medical necessity. This review is for the medical necessity of personal care worker service hours, 12 hours a day 7 days a week for a total 84 hours a week.

Personal Care Worker (PCW) services for 7 days per week, 12 hours per day; 84 hours per week is not medically necessary. The reduced hours of 77 hours per week is sufficient to meet the patient's needs.
The patient is 83-year-old female with past medical history significant for Parkinson's disease, bladder cancer with associated cognitive and physical disabilities.
She was previously receiving 84 hours a week of services which were decreased to 77 hours a week as services after nursing assessment / UAS. Patient is requesting to continue 84 hours a week as per the patient's power of attorney.
Insurance denied services stating the following:
You are able to walk and transfer with human assistance and use an assistive device/walker. You need assistance with toilet use. You were able to feed herself with meals that are prepared for you in advance. You are able to make your needs known.
Your activities of daily living needs during the calendar day, such as grooming, dressing, bathing, ambulation, transferring, toileting, meal preparation feeding are sufficiently infrequent and can be safely and adequately met through your current level of care, 7 days a week 11 hours per day. Your needs for incontinence are being met using incontinence supplies which meets the standards.
The Uniform Assessment System (UAS) State of NY was reviewed. The tasking tool noted total of 41.5 hours a week with an average of 5.9 hours a week 7 days a week. The tasking tool indicates that 5.9 hours a risk of her day are sufficient to meet the patient's needs. The plan is not required to include safety monitoring as a separate task.
According to documentation provided, UAS, tasking tools and nursing assessment, the patient has medical necessity of 41.5 hours a week as documented. She is currently approved for 77 hours a week which is above the documented need. The appeal failed to document additional need above the 77 hours a week for services. Additional services above this amount would be considered for safety monitoring which is not typically considered to stand alone service of the plan. In order for the services to be considered medically necessary, and appropriate activities of daily living (ADL) or Instrumental activities of daily living (IADL) must show a documented need.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Asthma.
Treatment: Fasenra.
The insurer denied coverage for Fasenra.

The denial is overturned.

The patient has severe persistent asthma on triple therapy with Advair, Spiriva and Albuterol as needed. The patient was also taking Prednisone as her asthma was poorly controlled. The patient was taking Montelukast and anti-allergic medication, Claritin, in addition. The patient was initiated on Macrolides three times a week. The patient was started on Fasenra for uncontrolled symptoms despite aggressive therapy.

Fasenra is indicated in severe uncontrolled Asthma. It is an IL5 (Interleukin 5) receptor Monoclonal Antibody. Usual Dosing schedule for Fasenra is 30 milligrams (mg) every 4 weeks for 3 cycles and subsequently 30 mg every 8 weeks. After starting on Fasenra the patient's symptoms improved and she was able to decrease her steroid dosing.

As per the physician's notes after switching administration from monthly to every 8 weeks the patient started to have return of significant symptoms after 4 weeks and started requiring Prednisone dosing with frequent exacerbations requiring Nebulizer therapy and frequent office visits. As per office visit the patient was having significant increase in her asthma symptoms. She was restarted on Prednisone 80 mg/day and was receiving nebulizers every 2 hours.

Given the fact that the patient had improved significantly while taking Fasenra every 4 weeks and on changing her to every 2-month regimen her symptoms worsened after 4 weeks with requirement of systemic steroids in high doses and with frequent nebulizer use.

This patient had severe persistent asthma and was showing significant improvement on Fasenra when it was being given every week. She started getting breakthrough symptoms at 4 weeks when 8 weeks regimen was tried.

Based on above and documentation provided by her doctor she should continue to receive Fasenra every 4 weeks for some more time until better control is achieved.

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

Based on the above, the medical necessity for the medication Fasenra every 4 weeks is substantiated. The insurer's denial is overturned.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Atopic Dermatitis. 
Treatment: Dupixent 300mg/2ml SC SOSY. 

The insurer denied the Dupixent 300mg/2ml SC SOSY. 
The denial is overturned. 

The patient is a female with atopic dermatitis to the scalp, face, trunk and extremities, treated with topical steroids (triamcinolone, hydrocortisone), topical calcineurin inhibitors, Eucrisa, methotrexate, systemic steroids, and anti-histamines.  The patient has responded favorably to Dupixent samples.  The provider is requesting Dupixent. 

Yes, the proposed treatment is medically necessary. 

The health plan denied the request as the patient is less than six years of age and Dupixent is Food and Drug Administration (FDA) approved for ages six and up. 

However, Dupixent is medically necessary.  This patient has failed all other standard and recommended therapies for atopic dermatitis.  Phototherapy is not appropriate given the scalp and facial involvement.  Other systemics are not approved for atopic dermatitis, and are not as safe nor effective as Dupixent in the current pandemic.   Dupixent is the only systemic medication with a Food and Drug Administratnion (FDA) approval for this condition. 

The FDA also approved dupilumab for the treatment of patients aged six years and older with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.  This approval followed a phase III, randomized, double blinded placebo controlled trial that enrolled 367 patients to evaluate the safety and efficacy of dupilumab in children (ages six to 11 years) for treatment of atopic dermatitis.  Significantly and clinically meaningful improvements in patients signs and symptoms of atopic dermatitis as well as quality of life were reported.  As seen in adults, treatment in pediatric population was reportedly well tolerated with the most commonly reported side effects including injection site reactions and conjunctivitis. 

There are ongoing trials looking at the use of Dupilumab in children as young as six months old.  A phase III clinical trial by Regeneron began enrolling patients and is looking at children between ages six months to 18 years and is assessing the long term safety and efficacy of dupilumab for atopic dermatitis.  In another two-part study, the safety, pharmacokinetics and efficacy of Dupilumb in patients six months to less than six years of age is being evaluated. 

Therefore, given the support in current literature for children under age six and lack of other options for this patient, Dupixent is medically necessary. 

No, the health plan did not act reasonably, with sound medical judgment and in the best interest of the patient.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Acute on chronic decompensated diastolic heart failure, chest pain, hypertension, hyperlipidemia, coronary artery disease, restrictive lung disease, type 2 diabetes mellitus, stage 3 chronic kidney disease, peripheral vascular disease, neuropathy

Treatment: Increase in Personal Care Assistance Services from 44 hours per week to Level 2 of 8 hours per day, 7 days per week for a total of 56 hours per week
  
The insurer denied coverage for increased Personal Care Assistance Services, Level 2 of 8 hours per day, 7 days per week for a total of 56 hours per week

The denial is overturned.

This is the case of a patient with a history of acute on chronic decompensated diastolic heart failure, chest pain, increased weight gain, hypertension, hyperlipidemia, coronary artery disease status post a coronary artery bypass graft, restrictive lung disease, type 2 diabetes mellitus, stage 3 chronic kidney disease, peripheral vascular disease, neuropathy and is undergoing an evaluation for a heart transplant. 

The Uniform Assessment System - New York (UAS-NY), notes the patient lives on the first floor of a private home with her spouse. The patient needs assistance for activities of daily living and instrumental activities of daily living related to her diagnoses of diabetes mellitus, heart failure, unsteady gait, sleep apnea, shortness of breath and a history of fall accidents. There were reported falls. The patient needs maximum assistance with meal preparation, ordinary housework, shopping and bathing. She needs extensive assistance with managing finances, managing medications, phone use, managing stairs, transportation, personal hygiene, dressing her upper and lower body and toilet transfer. The patient needs limited assistance with walking, locomotion, bed mobility and toilet use.  She is frequently bladder incontinent but has complete bowel control. She needs supervision, oversight or cueing with eating.  An increase of personal care assistance services, level 2 of 8 hours per day, 7 days per week for a total of 56 hours per week is being requested.

The patient is reported to use the bathroom 4 or more times per hour - related to her treatment of congestive heart failure. She needs assistance with toileting and has no informal support. This is confirmed by the patient's Social Worker. The patient is frequently incontinent of urine with only some control. The health plan did not act reasonably with sound medical judgment in the best interest of the patient.

The insurer's denial of coverage for the Personal Care Assistance Services, Level 2 of 8 hours per day, 7 days per week for a total of 56 hours per week is overturned. Medical Necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Dementia
Treatment: Personal Care Services
The insurer denied 24 hours per day, 7 days per week (live-in) personal care services, level 2.
The health plan's determination is overturned.

The patient is a female with past medical history of dementia, hypothyroidism, hypertension, hyperlipidemia, neuropathy, glaucoma, osteoarthritis, urinary incontinence, and recent cerebrovascular accident (CVA) who had been assigned PCS (personal care services) based on assessment tool performed via telephone assessing the patient at total assistance with tasks of meal preparation, ordinary housework, managing finances, and shopping while maximum assistance with tasks of stairs, transportation, bathing, and dressing lower body. The patient was assessed at extensive assistance with tasks of managing medication, phone use, personal hygiene, dressing upper body, walking, locomotion, transfer toilet, and toilet use while independent with tasks of bed mobility and eating.

The 24 hours per day, 7 days per week (live-in) personal care services, level 2 are medically necessary for this patient. 

The patient has documented assistance needs by physical therapy and occupational therapy at rehabilitation facility, as well as documentation of medical necessity for increased PCS by physician at rehab facility. The patient has assistance needs with all tasks except for bed mobility and eating. The patient has unpredictable and unscheduled care needs which span a continuum of time and the insurer failed to document a plan to meet these unpredictable and unscheduled care needs. The patient's care needs cannot be met solely with adaptive equipment and medical supplies. The patient's level of functioning and assistance needs are appropriate for community setting despite the insurer stating that they were not. The patient does not have formal or informal help and requires assistance with all tasks except for bed mobility and eating 24 hours/day. The requested increase in PCS is not solely for safety and supervision, but to assist the patient with safe completion of ADLs (activities of daily living) and IADLs (instrumental activities of daily living). Taking into account the clinical standards, all information provided regarding the patient, the attending physician's recommendations, and the applicable and generally accepted practice guidelines, 24 hours per day, 7 days per week (live-in) personal care services, level 2 are medically necessary for this patient. Personal care services are medically necessary when assistance with nutritional and environmental support function is essential to the maintenance of the patient's health and safety in her own home.