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

Diagnosis: Endometriosis
Treatment: Elective Fertility Preservation (CPT Code S4021) (Pre-Service)
The insurer denied the Elective Fertility Preservation (CPT Code S4021) (Pre-Service).
The denial is upheld. 

The patient is a female who, according to the provider, desires to preserve her fertility in the hopes of starting a family later in life. She underwent a diagnostic hysteroscopy and operative laparoscopy, which confirmed the suspected diagnosis of endometriosis. The patient had multiple segments of endometriosis laparoscopically excised and was diagnosed with stage II endometriosis.  The patient is requesting coverage for fertility preservation using oocyte cryopreservation.

No, the proposed treatment is not medically necessary.

This patient is requesting coverage for fertility preservation through oocyte cryopreservation. This patient does not have a diagnosis of infertility. This patient is not undergoing any treatment that will render her infertile in the future. She does not have a diagnosis of cancer necessitating gonadotoxic treatments (chemotherapy, pelvic radiotherapy, other gonadotoxic therapies), she is not undergoing surgery to remove her ovaries. Her only condition is stage II endometriosis that was treated surgically. There is no documentation that removal of the ovary is a planned management for the treatment of this patient's endometriosis.

Based on the above, the requested procedure is an elective procedure for the patient's convenience rather than a medically necessary one.  Based on the above, it is recommended to uphold the denial of elective oocyte cryopreservation.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Genitourinary/Kidney Disorder. 
Treatment:  Surgical services (nerve stimulator implantation).

The insurer denied the nerve stimulator implantation.  The denial was overturned in whole. 

The patient is a  female with long standing urinary retention and overactive bladder symptoms.  She is managing urinary retention with self-intermittent catheterization.  The patient has history of being treated and evaluated by two Urologist.  Per notes provided, sacral neuromodulation therapy is recommended by the urologist, but recommending physician doesn't offer magnetic resonance imaging (MRI) compatible system.  As a result, the patient was referred to a gynecologist who utilizes MRI compatible system. 

The subject under review is the medical necessity for the nerve stimulator.

The health plan's determination is overturned in whole. 

The nerve stimulator placement is medically necessary for this patient.  Reviewing provided medical records, specifically the operative note, it is clear that primary aim of the procedure was to improve her urinary retention.  There are no Food and Drug Administration (FDA) approved pharmacological treatment options for urinary retention; she is already performing intermittent self-catheterization daily.  The sacral nerve stimulator allows the patient to void normally.

Sacral neuromodulation is approved by the FDA for the treatment of non-obstructive urinary retention in women.  A recent meta-analysis of 14 studies confirmed the efficacy of sacral neuromodulation for non-obstructive urinary retention noting a mean decrease in post void residual (PVR) of 236 milliliter (mL).  This patient has history of urinary retention; she has been self-catheterizing four times per day.  Sacral neuromodulation therapy is approved for urinary retention.  It would be medically necessary, as it is the only FDA approved option for this diagnosis.  Additionally, it would be considered standard of care and within American Urology Association's guidelines for chronic urinary retention.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Movement Disorder (intrusive stereotypical movement)
Treatment: Ingrezza
The insurer denied the Ingrezza. 
The denial is upheld. 

The patient is a female with autism, seizure disorder and motor tic disorder. 

No, the requested Ingrezza is not medically necessary. 

There is no reason the patient cannot be treated with the preferred medication, deutetrabenazine for her condition. Current standard of care guidelines consider deutetrabenazine to be an appropriate treatment option for this patient's condition. There are no high quality clinical trials or standard of care guidelines supporting the preferential use of Ingrezza relative to the preferred medication deutetrabenazine.  The attending physician (AP) references the side effect profile and efficacy of tetrabenazine, which is not the preferred agent here. Moreover, the referenced article by the AP is not a high quality clinical trial directly comparing the efficacy of Ingrezza to the preferred agent deutrabenazine. Finally, the patient is already taking twice a day (BID) dosed medication (levetiracetam) and given the co-morbidities is not likely managing her own medications. Therefore, the value of dosing once a day verses twice a day in this clinical context is not realized as proposed by the AP appeal letter. 

Therefore, given the above, the treatment with Ingrezza is not medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Attention Deficit Hyperactivity Disorder (ADHD).
Treatment:  Amphet-Dextroamphet Cap ER 24HR 10MG (Adderall XR) twice daily.

The insurer denied the Amphet-Dextroamphet Cap ER 24HR 10MG (Adderall XR) twice daily.  The denial is overturned. 

The patient is a female with multiple sclerosis (MS).  She also has diagnoses of ADHD (attention deficit hyperactivity disorder) and daytime sleepiness secondary to the MS, which are treated with extended release amphetamine salts. 

The patient requests Adderall XR 10 milligrams (MG) twice daily.  The health plan has offered the equivalent total dosage in a once daily Adderall XR 20MG capsule.  The patient reports that she has migraines when she takes the 20MG as a single dose.

Yes, the treatment with Amphet-Dextroamphet Cap ER 24HR 10MG (Adderall XR) twice daily is medically necessary.

The absorption and metabolism of long acting Adderall formulations of different strengths are not linear, resulting in different peak plasma concentrations at different times.  Headache is a well-known side effect of stimulant medications and can be dose related.  This patient's complaint of migraine with the 20MG formulation is scientifically well-founded and should be taken into consideration.

The health plan denied coverage of Amphet-Dextroamphet Cap ER 24HR 10MG (Adderall XR) twice daily on the basis that the request exceeds the maximum recommended dosing frequency of once daily for the treatment of ADHD, based on the FDA product labeling.  However, this is a non-issue in this patient's case.  The manufacturer recommends once daily dosing, since that is the point of an XR formulation.  It also allows for clinical judgment, stating that treatment should be individualized according to the needs and response of the patient.  Finally, according to the absorption graph in the product label (3), it shows that both one dose of 20MG XR and BID (twice daily) dosing of instant release (IR) Adderall have almost identical high peak plasma concentrations at about six to seven hours, whereas 10MG of standard Adderall has a much lower peak.  Thus, BID dosing of XR 10MG should also be similar to that of IR Adderall, i.e. have lower peak concentration levels, thus avoiding dose-related side effects, such as the headaches that this patient experiences.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Neurotrophic keratitis.
Treatment: Formulary exception for Oxervate.
The insurer denied the Formulary exception for Oxervate.
The denial is upheld. 

The patient is a female with neurotrophic keratitis (NK) for whom a formulary exception for coverage of Oxervate is requested. Coverage was previously denied per policy as there was no documentation that the patient had decreased corneal sensitivity within an area of persistent epithelial defect or corneal ulcer and outside of the area of the defect in at least one corneal quadrant. 

An exam documents the patient following up for evaluation of neurotrophic keratoconjunctivitis of the right eye (OD) and dry eye syndrome OD greater than (>) left eye (OS), for which the patient was taking Restasis and Systane Ultra.  Vision was corrected to 20/60 OD and 20/25 OS. Corneal examination found intact epithelium, clear stroma and stroma, and superficial punctate keratitis bilaterally.  A graft was in place OD. The patient was found to have decreased corneal sensitivity to cotton wisp OD.  Oxervate was recommended six times per day.     

No, based on the records provided, the health plan should not cover the formulary exception for Oxervate.

On 08/22/2018, the FDA approved Oxervate (cenegermin) for the treatment of neurotrophic keratitis. Recommended dosage and administration is one drop of Oxervate in the affected eye(s), six times per day at two-hour intervals, for eight weeks.

According to the American Academy of Ophthalmology, NK is usually graded in three different stages:

1)Stage I is characterized by hyperplasia and/or irregularity of the epithelium, evolving to punctate keratopathy, corneal edema, neovascularization, stromal scarring.

2)Stage II is defined by a recurrent or persistent epithelial defects (PED), most commonly in the superior half of the cornea. The PED is usually oval in shape, and its margins are characteristically smooth and rolled due to impaired epithelial healing.

3)In stage III, stromal involvement leads to corneal ulcer, melting and perforation.

Oxervate is usually reserved for the treatment of stage 2 (moderate) or stage 3 (severe) neurotrophic keratitis.

In this case, the patient's stage of neurotrophic keratitis is not well characterized by the limited medical records provided for review. Other than superficial punctate keratitis, no other irregularity of the corneal epithelium is noted. Therefore, there is insufficient information to support the medical necessity of Oxervate in this case.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis:  Type 2 Diabetes.
Treatment:  Formulary exception for HumuLIN N KwikPen 100Unit/ML SC SUPN.
 
The insurer denied the Formulary exception for HumuLIN N KwikPen 100Unit/ML SC SUPN.  The denial is overturned. 

The patient is a female diagnosed with T2DM (type II diabetes mellitus). 

As reported, the patient has tried Lantus, Tresiba, Toujeo and Novolin N, all which have not been effective.  She experiences elevated sugar levels in the mornings due to dawn phenomenon, elevated sugars in the evenings, as well as unstable declines during the day without Humulin N.  She has been on Humulin N, and it has proven to be very effective.

This request is for Humulin N.

Yes, the health plan should cover the formulary exception for HumuLIN N KwikPen 100Unit/ML SC SUPN, because it is medically necessary.

The requested medication is NPH (neutral protamine Hagedorn).  It is FDA-approved for diabetes.  There are no studies showing superiority of one NPH formulation over another.  Novolin NPH and Humulin NPH are interchangeable [1-3].  However, the patient has tried the formulary alternatives, including Novolin.  The request is, therefore, medically necessary.
Appeal type: Medical necessity
Decision: Overturned in Part

Diagnosis: Neuralgia with facial pain
Treatment: Inpatient admission
The insurer denied the inpatient admission.
The denial is overturned, in part. 

Yes, in part; the inpatient admission was medically necessary.

The patient is a male with history of trigeminal neuralgia with facial pain who presented to the ED with severe attacks. The patient was admitted for pain control and given Dilantin with the plan for surgical treatment. Magnetic resonance image (MRI) was performed and the patient was planned for surgery. The patient underwent craniotomy for microvascular decompression. 

With regards to the inpatient stay, the acute inpatient level of care is deemed medically necessary as the patient underwent craniotomy and surgical decompression of the trigeminal nerve.  Acute inpatient level of care is deemed medically necessary and appropriate postoperatively as the patient required pain control and close neuro-checks to ensure that there were no complications postoperatively. 

However, there is insufficient evidence that the patient required acute inpatient level of care prior as the patient did not have any acute inpatient needs on these dates. The initial surgery was planned but was cancelled and the subsequent days until it was performed were not medically necessary for acute inpatient level of care.  

Therefore, the inpatient stay is partially approved.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Cerebral Aneurysm
Treatment: Inpatient stay
The insurer denied the inpatient stay.
The denial was reversed.

This is a female patient with a history of ruptured cerebral aneurysm (status post coiling and shunt), stroke, functional quadriplegia, metabolic encephalopathy, sepsis, urinary outlet obstruction, urinary tract infections, pneumonia, thoracic aortic aneurysm, hypothyroidism, hypertension, vascular dementia, thrombophlebitis, sacral decubitus, dysphagia, and a gastrostomy tube. The patient was transferred from a hospital to a skilled nursing facility (SNF) for reconditioning and medical intervention. The patient was treated by physical therapy (PT) and occupational therapy (OT) due to the patient's inability to ambulate. It was reported that within several weeks of therapy the patient was able to ambulate a significant distance with moderate assistance. The patient had a percutaneous gastrostomy tube (PEG). The patient's oral intake gradually improved allowing for the (PEG) to be removed. She received intravenous (IV) hydration for the treatment of hyponatremia. She had a stage 4 decubitus wound ulcer that was treated daily. The patient was medically stabilized and was discharged home.   

Based on the review of the medical record and literature, continued SNF level of care through the patient's discharge home was considered medically necessary.  The clinical records demonstrate the patient continued to require SNF level of care from admission the facility through the day of her discharge home.  The patient continued to benefit and improve as a result of the rehabilitation therapy services provided.  According to the physical therapy notes, the patient went from completely non-ambulatory upon admission and was able to ambulating approximately 100 feet with moderate assistance after a moderate period of time.  There was significant improvement as a result of speech therapy for swallowing and to a lesser extent from occupational therapy services. The patient's oral intake gradually improved and the percutaneous gastrostomy tube (PEG) was subsequently removed within several weeks after her admission. The patient's nursing and medical needs also supported the medical necessity of SNF level of care from admission. The patient had a stage 4 pressure ulcer that required at least daily treatment during her SNF length of stay.  During this time, the patient also required intravenous (IV) hydration for several days for hyponatremia.  The combination of the patient's functional impairments, nursing needs and medical status warranted continued SNF level of care from her admission to the facility through her discharge home.

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

The carrier's denial of coverage for the continuation of an inpatient stay in a skilled nursing facility (SNF) should be reversed.  The medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Substance abuse
Treatment: Outpatient substance abuse
The insurer denied the Outpatient substance abuse.
The health plan's determination of medical necessity is upheld in whole. The IOP is not medically necessary for this patient for the dates in question.

Based on the current literature and American Academy of Child and Adolescent Psychiatry (AACAP) recommendation of treating the patient in the least restrictive environment, the Intensive outpatient substance use treatment was not medically necessary for this patient. The patient has been in care for several weeks with boarding and had improvement of  behavior, safety concerns, and was medically stable in the days leading up to the dates in question. Based on the information provided, as of the dates in question, the patient had improved. The patient was stable on medications. In the days leading up to the dates in question, there was no indication the patient had engaged in self harm in the previous week. The patient was engaging in groups, individual therapy, and family therapy. The patient was doing better in school. The patient had no withdrawal symptoms and was medically stable. At that time, there was no indication the patient was engaging in high risk behaviors based on the documentation. Though the patient had deterioration of functioning this was weeks later. The requested IOP level of care with boarding was not medically necessary for the dates in question.
Per the Level of Care for Alcohol and Drug Treatment Referral (LOCADTR): recommendation is an "Adolescent Individualized Care plan."
Appeal type: Experimental/Investigational
Decision: Upheld

This is a male patient that was diagnosed with a right posterior neck melanoma.
He underwent an excision of the malignant melanoma in the right posterior neck and an attempted sentinel lymph node biopsy. DecisionDx-Melanoma genetic test was performed.   

The initial evaluation for risk of metastasis in patients with cutaneous melanoma uses the American Joint Committee on Cancer (AJCC) staging criteria, which includes Sentinel Lymph Node status. Per Trotter, S. C., Sroa, N., Winkelmann, R. R., Olencki, T., & Bechtel, M. (2013), "The stage at presentation of melanoma has a significant impact on the course of the disease. Most melanoma patients present with localized disease 82 to 85 percent of the time, followed by regional involvement 10 to 13 percent of the time, and distant metastatic disease 2 to 5 percent of the time.  The staging of melanoma holds prognostic value and dictates the recommendation in treatment.  Staging is determined by the tumor, node, and metastasis (TMN) system developed by the American Joint Committee on Cancer (AJCC).  Criteria include microstaging of the primary melanoma and pathologic information about the regional lymph nodes after partial or complete lymphadenectomy as well as a new emphasis on dermal mitotic index (measured in mm2) for T1 melanoma (=1 mm).  Survival and recurrence rates for melanoma follow the pathologic stages set forth by the AJCC and are used to guide follow-up recommendations."

Per Cirenajwis, H., Ekedahl, H., Lauss, M., Harbst, K., Carneiro, A., Enoksson, J.,  Jonsson, G. (2015), "Cutaneous malignant melanoma (CMM) is the most lethal form of skin cancer and its incidence has increased faster than that of any other cancer, rendering it a major public health problem worldwide.  In order to provide clinicians and patients with accurate prognostic information about the disease, a correct staging system is fundamental. Since 1998, the American Joint Committee on Cancer (AJCC) melanoma staging system has served as a foundation for clinical classification and it was recently updated to the 7th edition after adding more tumor intrinsic factors with prognostic significance."

In this case, the DecisionDx-Melanoma assay was not known to be effective based on a lack of scientific evidence showing that the results would accurately guide patient care and health outcomes, and the use of this testing was not supported by scientifically based guidelines of national medical research or governmental agencies. Furthermore, based on the results of the original biopsy and the clinical findings, this testing would not be of value in treatment planning for this patient.  Therefore, the DecisionDx- Melanoma assay 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 DecisionDx-Melanoma genetic testing should be upheld.
Appeal type: Medical necessity
Decision: Overturned

Substance Abuse/Addiction - Alcohol Abuse/Addiction
Substance Abuse: Inpatient

The patient is a homeless and unemployed male who was admitted  following medical screening to acute inpatient level services for monitoring and detoxification and withdrawal management of severe alcohol and stimulant (cocaine and crack cocaine) use disorders. The patient was using up to three pints of vodka daily with use of crack cocaine up to six days per week with up to $150 worth as well as intermittent use of cocaine with a quantity of 2 grams.

The patient was admitted to acute inpatient level care and placed on a detoxification regimen with a five-day Librium taper, vitamin replacement therapy, fluid replacement, and medical monitoring; the patient was tobacco dependent and offered smoking cessation treatment and nicotine replacement. Following his first day of treatment, the patient began to participate in counseling and educational sessions. Vitamins were continued, as well as comfort medications with monitoring and assistance with daily activities. He was maintained on fall and seizure precautions. His demeanor improved as he underwent detoxification treatment. Again, he participated in educational sessions and counseling during the remaining hospital stay through discharge. The patient was discharged to a rehabilitation treatment facility with recommendations for clinically appropriate aftercare, as well as recommendation for involvement in 12-step recovery meetings with Alcoholic Anonymous (AA) and follow up with his community providers of mental health and primary care.

The health plan's determination is overturned.

The proposed inpatient services and detoxification treatment and withdrawal management for severe alcohol use disorder and other services noted in the clinical summary could not have been safely and effectively provided at a lower level of care. The adult inpatient treatment of this patient's substance use disorders did require the admission and the continued structure of an inpatient level setting and 24-hour monitoring in view of the severity of the alcohol use disorder, and the presentation with the onset of withdrawal symptoms. Withdraw symptoms were managed with tapering dosages of Librium requiring monitoring, as well as comfort medications and vitamin replacement therapy. Thus, the patient did require a safe and effective detoxification with withdrawal management during the time frame under review, as it was reasonable that the patient would have been unable to abstain from the substances of abuse if detoxification and treatment were to be attempted at a lower level of care.