Persius/imr-appeals huggingface dataset:
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 


A 46-year-old female enrollee has requested authorization and coverage for Lamictal.  The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found that bipolar disorder represents a severe mental disease that has poor outcomes and an exceedingly elevated suicide rate. Considering the biological nature of this life-long, recurrent illness, pharmacotherapy is a primary treatment modality for bipolar disorder.  In this case, the patient has been clinically stable for over a year on an evidence-based bipolar maintenance medication regimen endorsed by current practice guidelines and community standards. The patient has been prescribed an appropriate pharmacotherapy that is consistent with good medical practice and reasonably expected to maintain her clinical stability and prevent an exacerbation of illness. As such, Lamictal has been established as medically necessary for treatment of the patients medical condition. Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer  
 
The patient is a 53-year-old female with a history of primary open-angle glaucoma. The provider 
states that Vyzulta is the only medication taken by the patient that has been efficacious. 
Therefore, the provider has recommended treatment with Vyzulta 0.024% drops. The Health 
Insurer has denied the requested treatment as not medically necessary for the treatment of the 
patients medical condition. The physician reviewer found that according to the American 
Academy of Ophthalmology (AAO) guidelines, a prostaglandin such as latanoprost, bimatoprost, 
or travoprost is the recommended initial treatment option to lower IOP for patients with primary 
open-angle glaucoma. The AAO guidelines state that, If target IOP is not achieved by one 
medication, then either switching or adding medications should be considered depending on 
whether the individual patient has responded to the first medication. The current medical 
literature has compared the efficacy of available prostaglandin analogue eye drops for the 
treatment  of  patients  with  glaucoma.  A  study  by  Cai  and  colleagues  demonstrated  that 
bimatoprost was more effective in reducing IOP than latanoprost in patients with open-angle 
glaucoma. The authors also concluded that there was no clinically significant difference in the 
IOP-reducing efficacy of travoprost, latanoprost, and tafluprost. In this case, the patient has a 
history of primary open-angle glaucoma. The records provided for review do not demonstrate 
that the patient has tried and failed treatment with bimatoprost. In addition, there is a lack of 
documentation that the patient has a contraindication to treatment with bimatoprost. Overall, 
the medical literature supports that bimatoprost is more efficacious in lowering IOP in patients 
with primary open-angle glaucoma than the requested Vyzulta. Therefore, the requested Vyzulta 
0.024% drops are not medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1

A 42-year-old female enrollee has requested reimbursement and prospective authorization and coverage for the Optune device with transducer arrays provided from 3/8/17 forward. The Health Insurer has denied this request indicating that the equipment at issue was and is considered investigational for treatment of the enrollees glioblastoma multiforme.   The physician reviewer found the patient is a 42-year-old female who  has a history of glioblastoma multiforme status post gross total resection, treatment with Temodar concurrent with radiation, followed with temozolomide in combination with tumor treatment fields (TTF) therapy with the Optune device. The patient started Optune therapy on 3/8/17. The patient has requested reimbursement and prospective authorization and coverage for the Optune device with transducer arrays provided from 3/8/17 forward. The Health Insurer has denied this request indicating that the equipment at issue was and is considered investigational. Optune is a wearable and portable, U.S. Food and Drug Administration (FDA) approved device that has been shown in clinical trials to safely deliver continuous therapy to the area of the brain where glioblastoma multiforme tumors are located. Optune is a noninvasive regional therapy that targets dividing cancer cells in the brain and generally does not harm healthy cells. The National Comprehensive Cancer Network (NCCN) guidelines have updated the recommendation for the treatment of glioblastoma multiforme. For the treatment of patients with glioblastoma multiforme with good performance status, a 2A recommendation was added for a treatment option for standard brain radiotherapy, with concurrent temozolomide and adjuvant temozolomide and TTF therapy. Overall, the addition of TTF to maintenance temozolomide chemotherapy can prolong progression free survival. Given these findings, the Optune device with transducer arrays provided from 3/8/17 forward was and is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the equipment at issue was and is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3

The parent of a one-year-old male enrollee has requested authorization and coverage for Olumiant
1 mg tablet. The Health Insurer has denied this request and reported that the requested medication
is investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that AGS is a rare genetic neurological disease with onset in infancy. This patient has a mutation in the
SAMHD1 gene, one of the genes that has been noted to be associated with AGS. Meesilpavikkai
and colleagues described the successful treatment of chilblains in AGS patients with a SAMHD1
mutation and consequent uparegulation of type I interferon activity. JAK/STAT activation is
present in various autoimmune diseases, and treatment with specific JAK inhibitors in immunemediated
diseases has been increasingly reported. The oral JAK1/2 inhibitor baricitinib (Olumiant)
has been approved for the treatment of active rheumatoid arthritis. Vanderver and colleagues
recently reported that treatment of patients with AGS using baricitinib resulted in decreased skin
manifestations and improved neurological function. An ongoing phase II clinical trial of baricitinib
in AGS is on hold due to the coronavirus pandemic. There is no standard therapy available for
AGS. The syndrome is progressive. There appears to be a narrow window of opportunity for
effective intervention. The requested medication may arrest the progression of ongoing
inflammation and neurological deterioration. Therefore, Olumiant 1 mg tablet is likely to be more
beneficial than other available standard therapy.
Appeal type: Medical Necessity
Decision: Upheld

Summary  
The patient is a 15-year-old male with a history of short stature and decreased growth velocity. 
The provider has recommended treatment with GH therapy. The Health Insurer has denied the 
requested treatment as not medically necessary for treatment of the patients medical condition. 
This denial is the subject of this appeal and determination. The physician reviewer found that 
current medical literature and guidelines from the Pediatric Endocrine Society recommend the use 
of GH to normalize adult height and avoid extreme shortness in pediatric patients with GH 
deficiency (Grimberg, et al.). In determining whether a patient has GH deficiency, a variety of 
factors should be considered, including GH stimulation testing, pituitary hormone testing, IGF-1 
testing, growth velocity, bone age, mean parental height, obesity, and height standard deviation. 
This  patients  records  document  a  history  of  short  stature  with  decreased  growth  velocity. 
However, a diagnosis of GH deficiency for this patient is not supported by the documentation 
provided  for  review.  Although  the  patient  has  a  decreased  growth  velocity  and  failed  GH 
stimulation testing, his predicted adult height is above his mean parental height and is within the 
normal range for age and gender. Additionally, the patient has a low-normal IGF-1 and a growth 
velocity of 4.5 cm per year in the last year. All told, the requested Genotropin is not medically 
necessary for treatment of this patient.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

The patient is a 16-month-old male who was born by Cesarean section at 32 weeks 3 days gestation. The patientas parent has requested reimbursement for occupational and speech therapy services provided from 7/24/20 through 8/20/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. The physician reviewer found that the submitted documentation supports the medical necessity of the services at issue. The patient was born prematurely, at 32 weeks 3 days gestation. He spent four weeks in the NICU, and required a feeding tube. He has documented developmental delays, including gross motor delays, apraxia, poor emotional regulation, and feeding difficulties. Spittle and colleagues compared the effectiveness of early developmental intervention program provided post hospital discharge to prevent motor or cognitive impairment in preterm infants versus standard medical follow-up of preterm infants at infancy, preschool age, school age, and adulthood. The authors noted, aInfants born preterm are at increased risk of developing cognitive and motor impairment compared with infants born at term. Early developmental interventions have been provided in the clinical setting with the aim of improving overall functional outcomes for these infants.a Spittle and colleagues noted, aEarly intervention programs for preterm infants have a positive influence on cognitive and motor outcomes during infancy, with cognitive benefits persisting into preschool age.a Woodward and colleagues stated that infants born before 34 weeks of gestation have three times the risk of impairments in multiple developmental domains compared with term infants. Bui reported, aPreterm children should be screened regularly for developmental delay, and parents of preterm infants should be counseled about the options of early intervention programs, and their potential positive impact on development.a In an article describing the importance of physical, occupational and speech therapy for infants born prematurely, Orton and colleagues noted, aThe developmental allied health team, consisting of physical therapy, occupational therapy, and speech pathology, is crucial in early evaluation of gross motor, fine motor, feeding, and language development. Surveillance of neurodevelopment in the first year of life is essential to ensure early detection of specific developmental delays and impairments, and to ensure timely referral for early intervention. Early intervention is not only important in optimizing long-term outcomes for the child, but it also plays an important role in enhancing the parent-child relationship and parental well-being.a The medical evidence supports the services at issue in this clinical setting. Therefore, occupational and speech therapy services provided from 7/24/20 through 8/20/20 were medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 


A 67-year-old male enrollee has requested reimbursement for HCPCS J0775, clostridial collagenase histolyticum injections provided on 11/07/16 and 11/10/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees Peyronies disease. The physician reviewer found that Peyronies disease is caused by scar tissue, called plaque, which forms along the length of the penis in the corpora cavernosa. This plaque is not visible, and depending on the severity of the condition, this condition can cause penile curvature with erection. The curvature can make intercourse difficult and/or painful for the patient and his partner. Potential treatments for Peyronies disease include surgery, minimally invasive treatment options, and medications. The results for most previously available medications and minimally invasive therapies have been inconsistent or lacked empirical support for effectiveness. The medical evidence supports the services at issue in this clinical setting. Thus, HCPCS J0775, clostridial collagenase histolyticum injections provided on 11/07/16 and 11/10/16 were medically necessary for the treatment of this patient. Therefore, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1


A 54-year-old female enrollee has requested reimbursement for Anser IFX measurement of serum infliximab (IFX) provided on 11/30/15. The Health Plan has denied this request indicating that the service at issue was considered investigational for evaluation the enrollees ulcerative colitis.The physician reviewer found the Anser IFX measurement of serum infliximab (IFX) provided on 11/30/15 was not likely to be more effective for this patient than other available treatment options. There is a lack of controlled data identifying the optimal drug level. A trial demonstrated this approach had no impact on clinical efficacy compared to empiric dose titration (Steenholdt, et al). It is well known for example that many patients respond very well with low drug levels. Additionally many patients have low levels of antibodies which are transient and insignificant clinically. Therefore, the testing at issue has not been validated using prospectively controlled data. All told, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1

A 66-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 5/17/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that the prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index has also been thought to add a bit to these statistics. There are two important decision points in the treatment of cutaneous melanoma. The first is
whether or not to do sentinel node; the pathology alone here strongly indicates that the procedure should be done. The second issue is that of whether adjuvant therapy should be given. Coupling the initial pathology, along with the results of the sentinel node, would give enough information to make the decision about adjuvant therapy.
DecisionDx-Melanoma testing is a study of 31 genes in an individualas melanoma cells. It then classifies that particular melanoma based on the five-year risk of metastasis. Gerami reported on 217 cases and found good correlation between DecisionDx-Melanoma testing prediction and prognosis in patients undergoing sentinel node biopsy. However, it is not clear how the DecisionDx-Melanoma testing five-year data compares to the ten-year Balch data. Most importantly, it is not known if it can be used to make therapeutic decisions beyond those that can be made on the pathologic data. Therefore, DecisionDx-Melanoma testing performed on 5/17/19 was not likely to have been more beneficial than other available standard therapy.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer  
 
The patient is a 53-year-old male who presented for a spine surgery evaluation on 6/8/22. The 
patient has requested authorization and coverage for inpatient surgery  disk replacement, 
cervical. The physician reviewer found that the submitted documentation does not support the 
medical necessity of the requested service. In this case, the records do not demonstrate that the 
patient is an appropriate candidate for the proposed cervical arthroplasty as an inpatient surgery 
as he not completed nonoperative therapies like physical therapy, injections, or chiropractic care. 
Such nonoperative therapies should be attempted before any surgical intervention as they would 
affect whether the proposed procedure should be an inpatient or outpatient surgery or whether 
the surgical recommendation should be an arthroplasty or fusion. While the patient reports 
weakness, which may be a reason to proceed with surgery at some point in the near future, the 
patients surgeon does not report that the weakness is profound or worrisome enough to 
represent an emergency or to cause permanent morbidity. Rather, the patients surgeon has 
recommended that the patient take the time to complete a cardiac evaluation and optimize his 
pulmonary function, during which time it would be appropriate for the patient to attempt 
nonoperative  therapies  for  his  chronic  symptoms.  Therefore,  inpatient  surgery    disk 
replacement, cervical, is not medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

A 51-year-old female enrollee has requested authorization and coverage for Provigil 200 mg tablets, 60 tablets per 30 days. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the medical necessity of the requested medication. The medical records indicate that the patient has a long history of hypersomnia. She has been evaluated by multiple specialists in order to maximize her medications. This patient has significant functional problems due to her hypersomnia as well as her bipolar disorder, as referenced by her use of the antipsychotic medication Clozaril, which is typically reserved for recalcitrant illnesses. Based on the records, the requested medication appears to be working well for her, and discontinuation of the requested medication could have significant adverse results. Therefore, Provigil 200 mg tablets, 60 tablets per 30 days are medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer  
 
The patient is a 42-year-old female with a history of treatment resistant, recurrent major 
depressive disorder. The patient has requested reimbursement and prospective authorization 
and coverage for adult mental health transcranial magnetic stimulation provided from 10/15/21 
forward. The physician reviewer found that per the medical literature, transcranial magnetic 
stimulation is indicated for severe, recurrent major depressive disorder that has not responded 
to traditional medication and psychotherapy treatment.  This patient qualifies for the diagnosis 
of treatment refractory depression given her two failed antidepressant trials in addition to 
psychotherapy.  This  patient  had  also  tried  electroconvulsive  therapy.  She  completed  five 
treatments but could not tolerate the confusion and headaches.  Additionally, she was evaluated 
by a psychiatrist who recommended transcranial magnetic stimulation at this point in her 
treatment. Based on the records, transcranial magnetic stimulation was the appropriate next 
step  in  treatment  for  this  patient.  Therefore,  adult  mental  health  transcranial  magnetic 
stimulation provided from 10/15/21 forward was and is medically necessary for the treatment of 
this patient.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

A 59-year-old female enrollee has requested authorization and coverage for an insulin pump. The Health Insurer has denied this request indicating that the requested device is not medically necessary for treatment of the enrollees diabetes. The physician reviewer found that insulin pump therapy is a technological advancement that has been developed to help patients manage type 1 diabetes. Insulin pump therapy is associated with psychosocial benefits and improved biomedical outcomes (Reidy, et al). Advantages of insulin pump therapy over multiple daily injections of insulin include better adherence, more accurate dosing, greater lifestyle flexibility, control of the dawn phenomenon without induction of nocturnal hypoglycemia, and the ability to suspend or temporarily reduce basal insulin to compensate for increased physical activity (Millstein, et al). While this patient has been able to manage her diabetes via insulin pump therapy, her current pump is no longer functioning. The patient requires a replacement pump in order to optimize her glycemic control. Accordingly, the requested insulin pump is medically necessary for treatment of this patients type 1 diabetes. Based on the foregoing discussion, the requested device is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 

A 62-year-old male enrollee has requested reimbursement for FoundationOne genomic profile tumor biomarker or gene expression testing performed on 3/01/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that atypical meningiomas are not malignant solid tumors. They are associated with a higher risk of recurrence after surgery. Further therapy may include radiation, but not typically systemic therapy. Next generation sequencing, such as with FoundationOne, is used to identify molecular markers for which targeted therapy exists, either in a clinical trial or as standard therapy. This patient would not be considered for systemic therapy based on his diagnosis, and next generation sequencing would be of limited utility in this case. Therefore, FoundationOne genomic profile tumor biomarker or gene expression testing performed on 3/01/18 was not medically necessary for the evaluation of this patient.