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

Summary Reviewer 


A 64-year-old female enrollee has requested authorization and coverage for Harvoni for 24 weeks. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus. The physician reviewer found Harvoni for 24 weeks is medically necessary for treatment of the patients medical condition. In the ION-2 study, 440 HCV patients underwent randomization and were treated, 20% had cirrhosis and 79% had HCV genotype 1a infection. The rates of sustained virologic response were high in all treatment groups. There was a 99% (95% confidence interval (CI), (95 to 100) in the group that received 24 weeks of ledipasvir-sofosbuvir and 99% (95% CI, 95 to 100) in the group that received 24 weeks of ledipasvir-sofosbuvir and ribavirin (Afdhal, et al). The results of an abstract were presented at the American Association for the Study of Liver Diseases Liver Meeting. In this double-blind study, Bourliere and colleagues randomized 155 patients previously unable to achieve SVR after sequential treatment with a peginterferon and ribavirin regimen followed by a protease-inhibitor (PI), peginterferon  and ribavirin regimen, to undergo treatment with ledipasvir/sofosbuvir and ribavirin placebo for 24 weeks or matching placebo for 12 weeks, followed by ledipasvir/sofosbuvir and ribavirin for 12 weeks. Patients were stratified by HCV subtype and their responses to their most recent therapy. Of the 77 patients treated with ledipasvir/sofosbuvir and ribavirin for 12 weeks, 4% experienced relapse; compared with 3% of the 77 patients treated with ledipasvir/sofosbuvir for 24 weeks, for a 3% total incidence of relapse. Based on the peer-reviewed literature, Harvoni for 24 weeks is medically necessary in this clinical setting. For the reasons provided, the requested medication is 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 57-year-old male requested authorization and coverage for implantation of device (the Coflex device) between the bones of the spine. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollees chronic lower back pain. The physician reviewer found that the medical evidence fails to support that the Coflex device, when used under these circumstances, results in any improved outcome when compared to laminectomy alone.  Moreover, there are studies that indicate that the Coflex device has to be removed in some cases, either due to infection or displacement due to a fractured spinous process. For these reasons, implantation of the Coflex device between the bones of the spine is not likely to be more effective than the standard available options for the treatment of this patients medical condition. Based upon the information set forth above, the requested device is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3

A 38-year-old male enrollee has requested authorization and coverage for a cardioverter defibrillator. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollee, who has cardiac sarcoidosis. The physician reviewer found that there is support for the requested device in this patients case. Implantable cardioverter defibrillators are indicated for patients with cardiac sarcoidosis who have an indication for permanent pacemaker placement. In this case, the patient has an indication for pacemaker placement, as he has symptomatic second degree atrioventricular block.  Therefore, the requested cardioverter defibrillator is likely to be more efficacious than other treatment options. Based upon the information set forth above, the requested device 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: Medical Necessity
Decision: Overturned

Summary  
The patient is a 28-year-old female with a history of a prior emergency hysterectomy due to 
placenta  accreta  and  postpartum  hemorrhage.  The  patient  is  requesting  coverage  for  IVF, 
intracytoplasmic sperm injection (ICSI), and assisted hatching. The Health Insurer has denied the 
services at issue as not medically necessary for the treatment of the patients medical condition. 
This denial is the subject of this appeal and determination. The physician reviewer found that this 
patient has requested coverage for IVF, ICSI, and assisted hatching. The records reflect that the 
patient underwent a hysterectomy. As the patient does not have a uterus, she will require IVF and 
a gestational surrogate in order to have biological children. Regarding ICSI, according to the 
American Society for Reproductive Medicine (ASRM) guidelines, in the absence of a male-factor, 
ICSI has not been shown to improve live birth outcomes. On the contrary, ICSI may lead to a 
decrease in live birth rates. Regarding assisted hatching, one medical study concluded that despite 
significantly improved odds of clinical pregnancy, there is insufficient evidence to determine 
whether assisted hatching has any effect on live birth rates (Zeng, et al.). The ASRM guidelines 
similarly state that laser-assisted hatching should not be routinely recommended for all patients 
undergoing IVF. Overall, the patient will require IVF and a gestational surrogate in order to have 
biological children. However, there is a lack of documentation indicating that this patient has a 
history of male-factor infertility. Therefore, ICSI is not indicated for this patient. Finally, the 
current medical literature and guidelines have not shown that assisted hatching is indicated for this 
patient. All told, the requested IVF is medically necessary for the treatment of this patient, but the 
requested ICSI and assisted hatching are not medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 


A 57-year-old male enrollee has requested reimbursement for orbitotomy without bone flap (right and left) and conjunctivoplasty reconstruction performed on 8/26/14.  The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition. The physician reviewer found based on the history of failed conservative management for the patients infection, the surgical exploration and scar release were medically necessary.  The patient had an unusual presentation of canalicular and orbital infection and did not improve with antibiotic treatment and canalicular debridement.  There is no evidence in the medical literature to suggest additional intravenous antibiotic or other alternative management would be preferable to surgical care for this case where oral antibiotics had already failed.  All told, orbitotomy without bone flap (right and left) and conjunctivoplasty reconstruction performed on 8/26/14 were medically indicated 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: Medical Necessity
Decision: Upheld

Summary Reviewer 




A 44-year-old male enrollee has requested reimbursement for the allergy immunotherapy treatment provided on 11/2/15. The Health Insurer has denied this request indicating that the medication at issue was not medically necessary for treatment of the enrollees Menieres disease and allergic rhinitis. The physician reviewer found that in the medical literature, Cox and colleagues noted that the intervals between maintenance immunotherapy injections generally range for four to eight weeks for venom and every two to four weeks for inhalants allergens but can be advanced as tolerated if clinical efficacy is maintained. In this case, the patient should be well into the maintenance phase, which does not require weekly injections. At times, providers will decrease doses if doses are missed, there are adverse reactions, or during pollen season. Larenas-Linnemann and colleagues report that doses are reduced when a patient comes in more than 14 days for five weeks after the last administration and initial dosing restarted after more than 30 days for 12 weeks since last administration during the build-up or maintenance stage. After missing one to three doses, the dosing schedules were mostly followed (build-up phase: repeat last dose, reduce by one dose, reduce by two doses; maintenance phase: reduce by one dose, reduce by two doses, reduce by three doses). For this patient, there is no evidence of missed doses, adverse events or other issues with allergy injections. As such, allergy immunotherapy treatment provided on 11/2/15 was not medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the medication at issue was not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3


A 28-year-old male enrollee has requested reimbursement for ColonSentry testing (CPT code 81479) performed on 10/23/14.  The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees medical condition. The physician reviewer found based on the documentation submitted for review, the patient may be in a family with Lynch syndrome. However, there is no specific genetic determination that the patient carries the Lynch genetics. Lynch syndrome (hereditary nonpolyposis colorectal cancer) is an autosomal dominant genetic abnormality that brings with it increased risk of multiple types of cancer, including colon cancer, endometrial cancer, and others. Because of this there are recommended programs of surveillance that have been recommended. In relation to colon cancer, affected patients should have colonoscopy every 1-2 years (Lindor, et al). The ColonSentry blood test measures the expression of seven genes whose expression is associated with colorectal cancer. Its purpose is to indicate to a patient his relative risk of the development of colon cancer. However, there is a lack of significant data as yet, to demonstrate any benefit to this test and it is not U.S. Food and Drug Administration (FDA) approved. In addition, it is not included within national guidelines for colorectal cancer screening (Levin, et al). There is also a lack of data to indicate that it provides meaningful data in the management of those with Lynch syndrome. In this case, the patient underwent colonoscopy surveillance, and there is no benefit to the additional use of ColonSentry testing. As such, the ColonSentry testing (CPT code 81479) performed on 10/23/14 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: Overturned

Summary Reviewer 3

A 53-year-old female enrollee has requested authorization and coverage for autologous cultured chondrocytes implant knee. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that there is a lack of support for the services at issue in this clinical setting. This patient has significant bipolar cartilage lesions in her knee in the patellofemoral joints bilaterally. There is a lack of evidence supporting autologous chondrocyte implantation for a bipolar lesion. Ogura and colleagues performed a study without a control group that addressed using autologous implantation for a bipolar lesion. However, without a control group, definitive conclusions cannot be drawn. The current standard would be a patellofemoral arthroplasty. Thus, autologous cultured chondrocyte implantation in the knee is not likely to be more beneficial than other treatment options.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3

[INSERT FIRST TWO SENTENCES FROM SUMMARY REVIEW DETERMINATION] The physician reviewer found that botox is a U.S. Food and Drug Administration (FDA) approved treatment for the treatment of migraines (Escher, et al). Botox is indicated for the treatment of chronic headaches in patients who have at least 14 headache days per month. In the peer-reviewed medical literature, Aurora and colleagues concluded that repeat treatment with five or fewer cycles of Botox was effective, safe, and well tolerated in adults with chronic migraine. This patient is documented to have daily migraine that has been refractory to standard migraine medications. Based on a review of the patients medical records and the current medical literature, the Botox injections (CPT code 64615) provided on 5/26/17, 8/25/17, and 11/17/17 were 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 services at issue were 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: Medical Necessity
Decision: Overturned

Summary Reviewer

The patient is a 55-year-old male who fell down a flight of stairs on 3/10/18, injuring his left shoulder, left hip, and lower back. He was evaluated in urgent care the next day. There was limitation of motion and pain in the left shoulder. X-rays did not reveal any fractures. Evaluation by primary care provider on 3/16/18 revealed limited motion and pain in the shoulder. Orthopedic referral and magnetic resonance imaging (MRI) scan was advised to rule out a rotator cuff tear. An orthopedic surgeon concurred with the recommendation for an MRI scan of the shoulder. The Plan denied the request for shoulder MRI as four weeks of stretching exercises had not been documented. The patient has requested authorization and coverage for MRI scan because of the acute injury, limitation of range of motion and continuing pain to rule out a rotator cuff tear. The Health Insurer has denied this request indicating that the requested services are not medically necessary for the evaluation of the patient. This denial is the subject of this appeal and determination. The patient has sustained significant acute trauma to the left shoulder as a result of a fall down a flight of stairs. X-rays have been negative for fractures. However, the pain and limitation of motion persists. Traumatic pain may result from a fracture or soft tissue injury, most commonly to the rotator cuff. Imaging starts with x-rays and depending on physical examination findings, as next steps, an MRI or MR arthrography for assessment of soft tissue injuries may be required. In light of the persisting pain, a month after the injury, the MRI is appropriate according to American College of Radiology appropriateness Criteria (Amini, et al). The nature of the acute trauma, continuing pain, and the physical examination findings are considered to establish an accurate diagnosis in a timely fashion and achieve an optimal result from any surgical intervention that may be necessary in an active individual. A more aggressive management and diagnostic strategy may identify those in need of early operative intervention and provide robust rehabilitation programs. As such, in this patients case the requested MRI scan has been demonstrated as medically necessary for the evaluation of this patients medical condition. Therefore, based on the reasons stated above, the requested services are medically necessary for the evaluation of this patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3

A 21-year-old female enrollee has requested authorization and coverage for Octagam infusions. 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 the autonomic nervous system regulates certain body processes, such as blood pressure and the rate of breathing. This system works automatically (autonomously), without a personas conscious effort. Disorders of the autonomic nervous system can affect any body part or process. Autonomic disorders may be reversible or progressive. Intravenous immunoglobulin is an immunological treatment. The patient in question carries several diagnoses, including autonomic nervous system dysfunction. Per the records, this patient has a suspicion of Spiky-Leaky syndrome. Xie and colleagues stated that IVIG may be considered with a clear-cut diagnosis. However, the diagnosis is just suspected in this patient.  The study by Weinstock and colleagues would not apply to this patient, as there is a lack of evidence submitted for this review to support a diagnosis of postural orthostatic tachycardia syndrome or the concurrent use of naltrexone in this case. There is a lack of evidence supporting IVIG as more efficacious than other available standard therapy in this clinical setting. Therefore, Octagam infusions are not likely to be more beneficial than any available standard therapy.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 


A 36-year-old male enrollee has requested authorization and coverage for epidural steroid injections. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees degenerative spondylosis and disc disease. The physician reviewer found that in the documentation available for review, the patients records do not demonstrate that he been treated with physical therapy even though it was recommended by his provider. Physical therapy with active exercise is indicated in this clinical setting. Further, the medical literature suggests that a home exercise program after physical therapy independent of an epidural injection can provide lasting results. Moreover, the patient does not have any recent physical exam findings or imaging studies to support a diagnosis of lumbar radiculopathy, which would be one indication for epidural steroid injections (Manchikanti, et al; Kaye, et al). Given the available records, there are standard treatment options for low back pain that have not been performed (Hooten and Cohen; Derby, et al). Given these findings, the requested epidural steroid injections are not medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the requested services are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1

A 52-year-old male enrollee has requested authorization and coverage for olaparib (Lynparza) tablet 100 mg. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees prostate cancer. The physician reviewer found that Lynparza has been approved for use in patients with BRCA positive breast cancer or ovarian cancer. There is early experience with Lynparza in prostate cancer, mostly demonstrating some efficacy only in patients with DNA repair mutations, such as BRCA or ATM (Sonnenburg and Morgans). This patient was found to have the FANCA mutation, which is a related type of mutation. However, thus far, there is a lack of data demonstrating that patients with this mutation will obtain a meaningful response to Lynparza. Clarke and colleagues suggested that regardless of mutation status, there is somewhat better progression free survival with a combination of Lynparza and abiraterone than with abiraterone alone, though there was considerable toxicity in the combination arm. Given these findings, the requested Lynparza tablet 100 mg is not 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 requested medication is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2


A 64-year-old female has requested reimbursement for FoundationOne testing performed on 1/13/16.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the submitted documentation fails to demonstrate the superior efficacy of the services at issue.  Carcinosarcoma is an aggressive uterine cancer often treated similar to high-grade endometrial cancer.  Per the medical evidence, molecular genetics on individual tumors has not yet been shown to be fruitful in the majority of cases.  This testing is not recommended as a standard of care for the treatment of uterine cancers per the current guidelines.  In sum, FoundationOne testing performed on 1/13/16 was not likely to have been superior over other methods of evaluating this patient.  Based upon the information set forth above, the services at issue were 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 3

A 67-year-old male enrollee has requested authorization and coverage for sacroiliac joint fusion. The Health Insurer has denied this request indicating that the requested service is considered investigational for treatment of the enrollees bilateral sacroiliac joint pain status post revision lumbar surgery. The physician reviewer found that this patient presents with persistent severe left greater than right SI joint pain. Functional difficulty was documented with activities of daily living and ambulation. He is status post multiple lumbar fusion surgeries resulting in L3-4, L4-5 and L5-S1 interbody fusion with posterior instrumentation from L3 to S1. He has reported progressively worsening bilateral SI joint pain following the last surgery on 11/1/16. There is evidence of long-term conservative treatment including medications, cane/walker use, bracing, activity modification, SI joint injections, home exercise program, and physical therapy without sustained improvement. Clinical examination findings have documented SI joint tenderness with three positive SI provocative tests. In addition, there is radiographic evidence of SI joint sacroiliitis. Moreover, bilateral SI joint injections have been documented with 90-100% temporary pain relief. Current evidence based medical guideline and peer-reviewed surgical indications for SI joint fusion have therefore been met. Accordingly, the requested SI joint fusion 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 requested service 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.