Persius/hicric huggingface dataset:
Appeal type: Experimental/Investigational
Decision: Overturned

Reviewer # 2

This case involves a male patient with a diagnosis of anterior uveal melanoma of the left eye.  The diagnosis was made in several years ago and the patient had been treated with brachytherapy. He was found also to have a mesenteric mass and this was removed surgically. He was found to have recurrent metastatic melanoma in the right lobe of his liver and underwent radio embolization in mid 2018. In early 2019 imaging with MRI showed progressive liver disease and he was recommended for combination treatment with ipilimumab and nivolumab which he started in early 2019. He was given nivolumab at 3 mg/kg and ipilimumab 1 mg/kg.  On a specified date he had cycle #3 and on another date he had cycle #4. 

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

The patient has a history of metastatic uveal melanoma to the liver, recurrent after local treatment. The use of ipilimumab and nivolumab combination as first-line systemic therapy for metastatic melanoma is considered the standard of care.  Although the responses for these drugs in uveal melanoma are less than that seen in cutaneous melanoma, there have been studies showing some responses.  Pelster, et al (1) reported a phase 2 study of this combination and metastatic Mobile melanoma which showed a partial response of 17% with 53% showing stable disease.  Similarly, Rodriguez, et al (2) presented an additional phase 2 single arm study of this combination in patients with uveal melanoma which resulted in 12% overall response rate with 52% disease stabilization rate. The current National Comprehensive Cancer Network (NCCN) Guidelines Melanoma 1.2019 considers the use of this combination as systemic therapy for uveal melanoma to be a category 2A recommendation, which indicate uniform consensus.      

The combination of ipilimumab and nivolumab is currently FDA approved in patients with unresectable or metastatic melanoma.  
The patient is a good candidate for this combination therapy as he has a metastatic melanoma that cannot be resected; therefore, he meets FDA criteria. The combination therapy is considered the best available treatment at this time.  It is a consensus recommendation from the NCCN guidelines and no additional therapies are found to be superior based on current medical literature. The combination of ipilimumab and nivolumab is at this time likely to be the most beneficial treatment for this patient than any standard treatments/procedures based on current guidelines and literature.  No additional treatments are superior based on current literature.    

The carrier's denial of coverage for Yervoy (ipilimumab) 1 mg injection (code J9228) and Opdivo (nivolumab) 1 mg injection (code J9299) for the dates of service specified
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Anterior uveal melanoma of the left eye

Treatment: Yervoy (ipilimumab) 1 mg injection (code J9228) and Opdivo (nivolumab) 1 mg injection (code J9299)

The insurer denied coverage for Yervoy (ipilimumab) 1 mg injection (code J9228) and Opdivo (nivolumab) 1 mg injection (code J9299). The denial was reversed.

Reviewer #1

This patient is a male with metastatic uveal melanoma to be put on Opdivo and ipilimumab.

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

The patient has metastatic melanoma that cannot be resected.  These two drugs are appropriate for metastatic uveal melanoma as there are studies that support its use.  A retrospective series of 8 patients showed two of the patients had a partial response, while four others had stable disease.  Two other patients experienced disease progression.

"Major improvements have followed the introduction of B-Raf proto-oncogene/mitogen-activated protein kinase kinase [BRAF/MEK] inhibitors and immunotherapy in metastatic cutaneous melanoma.  Unlike cutaneous melanoma, several studies report lack of BRAF kinase mutations, suggesting lack of benefit from BRAF inhibitors in patients with advanced uveal melanoma [1517].  Oncogenic mutations in G-protein subunits a (GNAQ) and 11 (GNA11) have been described in 80% of uveal melanomas" (Karivedu, V. et al. 2019) "There is currently no standard approach for metastatic uveal melanoma [UM]. Early studies of single agent immunotherapy (IO) in metastatic UM have yielded meager results.  Combination checkpoint inhibitor IO has the potential to improve response rates and survival.  Herein, we report the safety and efficacy of ipi/nivo in metastatic UM" (Pelster, M. et al. 2019). Yervoy (ipilimumab) 1 mg injection (code J9228) and Opdivo (nivolumab) 1 mg injection (code J9299) have final approval from the appropriate regulatory bodies for this diagnosis.     

This patient is a good candidate for Yervoy (ipilimumab) 1 mg injection (code J9228) and Opdivo  (nivolumab) 1 mg injection (code J9299)     

Yervoy (ipilimumab) 1 mg injection (code J9228) and Opdivo (nivolumab) 1 mg injection (code J9299) are the best available treatment for this patient at this time.     
  
The requested service is likely to be more beneficial than any of the standard treatments/procedures for this patient.                                                    

The carrier's denial of coverage for Yervoy (ipilimumab) 1 mg injection (code J9228) and Opdivo (nivolumab) 1 mg injection (code J9299) for the dates of service specified should be reversed.
Appeal type: Experimental/Investigational
Decision: Overturned

Reviewer # 3

This patient is a male diagnosed with anterior uveal melanoma of the left eye. He initially had brachytherapy to the left eye. He developed a lesion in the liver. He subsequently received Y-90 radiation. There was an increase in the size and number of the liver lesions on the MRI.  In early 2019 ipilimumab and nivolumab treatment was started.

The scientific evidence in peer-reviewed literature supports improvement in health outcomes.
The development of checkpoint inhibitors, such as ipilimumab and nivolumab, which modulate the effects of the cytotoxic T-lymphocyte associated protein 4 [CTLA-4] and programmed cell death protein 1 [PD-1], respectively, has revolutionized outcomes for these patients.  Monotherapy improves metastatic disease survival, but dual therapy provides greater benefit with 58% of patients alive at 3 years." (Carreau, NA., Pavlick, AC. 2019)"Ipilimumab was the first checkpoint inhibitor to gain FDA approval by demonstrating a survival benefit in metastatic melanoma patients in a prospectively randomized Phase III clinical trial. Pembrolizumab was initially approved for ipilimumab-refractory metastatic melanoma patients; however, the indication was expanded to the first-line setting based on KEYNOTE-006 results" (Force, J., & Salama, A. K. 2017) "Newly emerging treatments include the anti-programmed cell death 1 receptor agents (nivolumab and pembrolizumab), anti-programmed death-ligand 1 agents, and oncolytic vaccines (talimogene laherparepevec) Available treatments for select sites include adoptive T cell therapies and dendritic cell vaccines"(Maverakis, E. et al. 2015).

Yervoy (ipilimumab) 1 mg injection (code J9228) and Opdivo (nivolumab) 1 mg injection (code J9299) does have approval from the regulatory bodies, as it is approved for metastatic melanoma.  
   
The patient has metastatic melanoma with primary uveal melanoma. He has metastasis to the liver. It is an appropriate indication for this combination.   This is appropriate treatment for this patient.  It is recommended per National Comprehensive Cancer Network (NCCN) guidelines and Immunotherapy.          
The requested service is likely to be more beneficial than any of the standard treatments/procedures for this patient.The carrier's denial of coverage for Yervoy (ipilimumab) 1 mg injection (code J9228) and Opdivo (nivolumab) 1 mg injection (code J9299) should be reversed.
Appeal type: Experimental/Investigational
Decision: Overturned

Reviewer # 2

This case involves a male patient with a diagnosis of anterior uveal melanoma of the left eye.  The diagnosis was made in several years ago and the patient had been treated with brachytherapy and had a decrease in the size of the melanoma. It was discovered that the patient had metastatic melanoma of the right lobe of his liver and he underwent radioembolization with Y-90. However, a follow-up MRI revealed the patient had new melanoma metastasis in the left lobe of his liver.  The oncologist recommended immunotherapy since there was now metastasis on both sides of his liver. The patient agreed to a course of Yervoy and Opdivo every three weeks which began in early 2019. The doses were based on the patient's weight and the initial doses were 89 mg of Yervoy and 266 mg of Opdivo administered via intravenous (IV) infusion.  

The Yervoy and Opdivo treatment that this patient received for his metastatic uveal melanoma is standard of care.  
There are several human clinical trials that show the efficacy of Yervoy and Opdivo.  Notably, results from phase 2 and 3 trials in patients with advanced melanoma have shown significant improvements in the proportion of patients achieving an objective response and prolonged progression-free survival with combination of nivolumab and ipilimumab. 1 This patient with uveal melanoma clinically has advanced melanoma.  Nivolumab and ipilimumab have been studied in metastatic uveal melanoma. 2

Yervoy and Opdivo are FDA approved drugs for the indication that was used in this patient, metastatic melanoma. Yervoy and Opdivo are indicated as an appropriate next step, at the time that they were administered to the patient, according to NCCN and (National Comprehensive Care Network) guidelines for uveal melanoma Version 1.2019.  Immunotherapy including Yervoy and Opdivo are listed as a recommended regimen for systemic therapy for distant metastatic disease such as in the liver.

The requested treatment is likely to be more beneficial than any of the standard treatments/procedures for this patient. The carrier's denial of coverage for Yervoy (ipilimumab) 1 mg injection (code J9228) and Opdivo (nivolumab) 1 mg injection (code J9299) should be reversed.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Anterior uveal melanoma of the left eye

Treatment: Yervoy (ipilimumab) 1 mg injection (code J9228) and Opdivo (nivolumab) 1 mg injection (code J9299)

The insurer denied coverage for Yervoy (ipilimumab) 1 mg injection (code J9228) and Opdivo (nivolumab) 1 mg injection (code J9299). The denial was reversed.

Reviewer #1

This patient is a male with metastatic uveal melanoma to be put on Opdivo and ipilimumab.

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

The patient has metastatic melanoma that cannot be resected.  These two drugs are appropriate for metastatic uveal melanoma as there are studies that support its use.  A retrospective series of 8 patients showed two of the patients had a partial response, while four others had stable disease.  Two other patients experienced disease progression.

"Major improvements have followed the introduction of B-Raf proto-oncogene/mitogen-activated protein kinase kinase [BRAF/MEK] inhibitors and immunotherapy in metastatic cutaneous melanoma.  Unlike cutaneous melanoma, several studies report lack of BRAF kinase mutations, suggesting lack of benefit from BRAF inhibitors in patients with advanced uveal melanoma [1517].  Oncogenic mutations in G-protein subunits a (GNAQ) and 11 (GNA11) have been described in 80% of uveal melanomas" (Karivedu, V. et al. 2019) "There is currently no standard approach for metastatic uveal melanoma [UM]. Early studies of single agent immunotherapy (IO) in metastatic UM have yielded meager results.  Combination checkpoint inhibitor IO has the potential to improve response rates and survival.  Herein, we report the safety and efficacy of ipi/nivo in metastatic UM" (Pelster, M. et al. 2019). Yervoy (ipilimumab) 1 mg injection (code J9228) and Opdivo (nivolumab) 1 mg injection (code J9299) have final approval from the appropriate regulatory bodies for this diagnosis.     

This patient is a good candidate for Yervoy (ipilimumab) 1 mg injection (code J9228) and Opdivo  (nivolumab) 1 mg injection (code J9299)     

Yervoy (ipilimumab) 1 mg injection (code J9228) and Opdivo (nivolumab) 1 mg injection (code J9299) are the best available treatment for this patient at this time.     
  
The requested service is likely to be more beneficial than any of the standard treatments/procedures for this patient.                                                    

The carrier's denial of coverage for Yervoy (ipilimumab) 1 mg injection (code J9228) and Opdivo (nivolumab) 1 mg injection (code J9299) should be reversed.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Cervical shortening

Treatment: Inpatient hospital admission

The insurer denied coverage for inpatient hospital admission. The denial was upheld.

This patient is a female who was admitted at 25.3 weeks gestation because of cervical shortening. The patient has been maintained on vaginal progesterone and followed up with cervical length measurements. The fetus was stable. There was no bleeding, contractions, or sign of infection. The patient had a short cervix. She was admitted and placed on magnesium sulfate. The patient was already receiving vaginal progesterone. The patient was not in labor.

The value of hospitalization for women with short cervix has been studied and the scientific literature showed that admission to the hospital was not associated with a decreased rate of preterm delivery and there was a trend toward hospitalization as an independent risk factor for delivery at < 34 weeks, an earlier gestational age at delivery, and a shorter time from diagnosis to delivery. Hospitalization was independently associated with an increased rate of cervical shortening.

Another study showed that activity restriction did not reduce the rate of preterm birth in asymptomatic nulliparous women with a short cervix. The patient did not have any contractions. The fetal heart was reassuring. She was afebrile. She could have been followed as an outpatient with serial ultrasound monitoring of her cervical length.

Based on the progress notes other than receiving magnesium sulfate nothing was done in the hospital. In summary, inpatient admission was not medically necessary.


The patient received Magnesium sulfate for neuroprotection on day of admission. The progress notes for several dates all mentions that the patient was stable with no active management of the patient. The patient was discharged.

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

Based on the above, the medical necessity for the acute inpatient hospital admission is not substantiated. The insurer's denial is upheld.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Kidney stone
Treatment: Inpatient stay
The acute inpatient stay was medically necessary.  

The patient is a G11 P4155 female who was admitted to the hospital at 21 weeks three days for flank pain related to nephrolithiasis.  She was afebrile but had a white count of 20.4.  Renal ultrasound showed kidney stone and could not exclude left ureteral stone.   She was treated with intravenous fluid and intravenous Ofirmev and morphine for pain control.  She was evaluated by urology and cleared for discharge on hospital day #2.  

The patient had failed outpatient treatment with oral pain medication and required intravenous hydration and parenteral pain medication for adequate pain control. Standard of care and compassionate care require that patients with nephrolithiasis receive adequate pain control and intravenous hydration.  Therefore, the admission was medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Infection (hematuria)
Treatment: Inpatient admission
The Inpatient admission was not medically necessary.

An acute inpatient level of care was not medically necessary.  The patient's care could have been provided at a lower level of care.  She was afebrile and hemodynamically stable through to discharge. There was no significant evidence for sepsis.  Following admission, there were no unstable vital signs reported.  She did not have kidney failure, solitary kidney or a kidney transplant, or need for an open surgery. She did not have bilateral obstruction, acute renal failure, severe vomiting.  IV antibiotics in a non-toxic patient previously discharged from an outside hospital can be provided at a lower level of care.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Tingling and numbness of the left side of the face and arm
Treatment: Inpatient admission

The Inpatient admission was not medically necessary.

The patient is a female with a history of multiple sclerosis. She presented with the complaints of left arm heaviness, numbness and tingling and left face numbness.  Her symptom had resolved at the time of presentation. 

At presentation, the patient's neurological examination was normal. She was not considered a candidate for any acute intervention. MRI and MRA were done and showed a right thalamic infarct. She had an echocardiogram, was started on a statin and anti-platelet agent and discharged home.

The patient has a small ischemic stroke. She had clinically improved at presentation. She was not a candidate for acute intervention, and she had no significant deficit on examination.  The diagnostic tests, treatment and monitoring could have been provided at a lower level of care. The current standard of care management in this clinical context does not require acute inpatient level of care.
Appeal type: Medical necessity
Decision: Overturned

Depression 
Mental Health Inpatient

The case involves a patient admitted for acute inpatient level care for worsening symptoms of anxiety, depression and suicidal ideation. The patient was brought in by emergency services to the emergency department with panic attacks, chest pain and suicidal ideation. The patient reported non-adherence with antidepressant medication. Also, he had a history of an abnormal electrocardiogram (EKG), but no other general medical conditions other than somatic symptoms of anxiety including headaches. The health plan's determination of medical necessity is overturned. The patient's Continued Inpatient Mental Health Stay was clinically appropriate, reasonable, and in the best interest of the patient. The patient had severe symptoms of depression and anxiety, and he was a safety risk, and, outpatient treatment had failed to prevent the worsening symptoms of depression and anxiety with onset of severe symptoms in the context of medication non-adherence and history of past suicidal behavior. The patient remained a safety risk and functionally impaired with high risk for relapse if discharged .Thus, it was medically necessary for this patient with major depressive disorder and Panic Disorder and Generalized Anxiety Disorder and safety concerns to remain in the acute inpatient setting in order to continuously assess his risk of suicidal or impulsive behaviors, and to address the acute risks of a return to the community with the noted functional impairments and treatment issues, as well as the need to develop a safe and clinically appropriate discharge plan and disposition with clinically appropriate aftercare.
This is consistent with prevailing standards of professional practice, the scientific literature, and published practice guidelines.
Appeal type: Medical necessity
Decision: Upheld

Male Genital Disorders
Inpatient Hospital 

This is a patient, at the time of admission, who presented to the emergency room  with pain to the  right testicle for 2 days. There was some history that the patient may have had trauma from a bike seat after falling off a bike. The patient  reports increase in pain with movement. The patient  reported to the ER and testicular torsion was ruled out by ultrasound (US).  The US was read by the surgeon as suspected early right epididymitis; blood flow was seen to both testicles.
The health plans determination of medical necessity is upheld in whole. 
The Inpatient stay was not medically necessary in this case.
The patient did not meet any criteria for admission. Current practice and evidence-based literature recommend conservative management with analgesics and elevation for epididymitis. Given the low incidence of urinary tract infections in boys with epididymitis, in prepubertal patients, antibiotic therapy can be reserved for young infants and those with pyuria or positive urine cultures.
This patient did not need emergent surgical intervention. The patient  was never febrile. The  condition resolved very quickly. There was no failure of outpatient management. With the negative urinalysis (UA) and negative inflammatory markers, a lower level of care would have been safe and appropriate for this patient. Surgical emergency of testicular torsion was ruled out. Therefore, the Inpatient stay was not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Bacterial infection
Inpatient hospital stay

The patient presented with swelling to the left axilla for 2 days. The patient reported the area was very painful on the day of presentation. Patient denied fever, cold, or cough. The emergency room (ER) examination documents a left axillary mass, fluctuant 2 centimeter (cm) x 2 cm surrounded by an indurated area of 3 cm x 4 cm. Labs revealed a white blood cell count (WBC) 9.6, otherwise the labs were unremarkable. The patient was admitted with a left axillary suppurativa hidradenitis for antibiotic coverage and incision and drainage. After admission to the hospital the area in question spontaneously ruptured and a large amount of pus drained. The patient was cleared for discharge on oral clindamycin and nonsteroidal anti-inflammatory drugs (NSAIDS) for pain, and follow-up (F/U) with the surgery clinic after discharge. The health plan's determination of medical necessity is upheld in whole. This patient did not meet any criteria for inpatient admission. During the stay there were no adverse events, failure of therapy or need for stepped up care that would warrant inpatient admission. This patient could have safely received treatment at a lower level with close follow up with her primary medical doctor (PMD) or surgeon. After < 24 hours on IV antibiotics, the abscess spontaneously ruptured and drained. The patient did not require any surgery, highly skilled or technical care while in house.