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

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for the WalkAide functional electrical stimulator (FES) for treatment of the enrollees hereditary spastic paraplegia. Findings:  The physician reviewer found that the request for the WalkAide FES is not medically necessary for treatment of this patients medical condition. A review of the peer-reviewed medical literature reveals that the WalkAide can be used in spinal cord injury patients for walking in the home after the patient has completed an adequate trial of physical therapy with the device over a period of three months. This trial period can allow the patients provider to properly evaluate the patients safety and ability to use the device for the long-term. A review of the literature also states that patients require muscle and joint stability for weight bearing at upper and lower extremities that can demonstrate balance and control to maintain an upright support posture independently prior to using the WalkAide device. The documentation reveals that the patient has only had a two week trial of this WalkAide device and does not include objective documentation of objective measurable functional improvement. The records indicate that the patient has difficulty maintaining her posture for stance due to equinovarus deformity. She also has significant lower extremity spasticity as noted in her providers documentation. Furthermore, the literature does not support that a FES has been proven to be effective for ambulatory function and muscle strength for progressive diseases in patients without spinal cord injury. All told, the requested WalkAide FES is not supported as medically necessary. Final Result: The reviewer determined that the requested device is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: The reviewer is board certified in physical medicine and rehabilitation with sub-specialty certification in neuromuscular medicine and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Experimental/Investigational
Decision: Overturned

A 59-year-old female enrollee has requested for transcranial magnetic stimulation (TMS) for treatment of her major depressive disorder.  Findings:  Two physician reviewers found that this patient has been treated with multiple available standard therapies without improvement in symptoms. The FDA has approved TMS as a specific treatment for severe depression and gives guidelines for its use. Additionally, the American Psychiatric Association (APA) included TMS in their 2010 guidelines as an appropriate acute phase treatment option for patients who do not respond adequately to medication therapy. Further, the American Medical Association (AMA) has approved Category I CPT codes for TMS effective in January 2011. The patient states in her letter that ECT was seriously considered and rejected because of its potential side effects. Several articles are cited from the literature that shows that TMS compares favorably with ECT. Grunhaus and colleagues reported that their conclusion is particularly relevant because it suggests that rTMS and ECT reach similar results in nonpsychotic major depressive disorder. Similarly, Eranti and colleagues noted that although ECT was more effective in the short term, at 6 months the HAM-D scores did not differ between groups. Self- and observer-rated cognitive measures were similar in the two groups.
Appeal type: Medical Necessity
Decision: Overturned

A 59-year-old male enrollee has requested a 27 inch transfer board for treatment of her status post bilateral below the knee amputation.  Findings:  The physician reviewer found that the requested transfer board is medically necessary and will allow for this patient to accomplish safe transfers between the wheelchair and the bed or toilet. Without the transfer board, the patients ability to transfer from his wheelchair is limited, especially when he does not have his prosthesis on (such as when he sleeps at night). A transfer board is a commonly accepted and standard piece of equipment that will allow transfers in this clinical scenario. This patient is status post bilateral below the knee amputation, and this significantly limits his ability to transfer. All told, in this patients case, the requested 27 inch transfer board is medically indicated.
Appeal type: Medical Necessity
Decision: Overturned

A 57-year-old female enrollee has requested left breast ultrasound-localized needle bracketed segmentectomy with sentinel lymph node biopsy and possible lymph node dissection of the left breast and axilla for the treatment of her multi-focal left breast cancer. Findings:  The physician reviewer found that the requested needle bracketed segmentectomy is a standard of care surgical option offered to women with breast cancer. The treatment plan was presented to the patient who is in agreement with the approach. This patients initial core biopsy was performed a few months ago and it would be prudent to proceed with the needle-bracketed approach as quickly as possible.
Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary:   An enrollee has requested serum adalimumab testing for the amount of adalimumab and antibodies to adalimumab (Prometheus Anser ADA testing) for evaluation of her Crohns disease.  Two physician reviewers found that the use of Anser ADA has not been demonstrated in randomized controlled clinical trials to improve patient outcomes. In this case, Anser ADA was ordered to determine the cause for possible loss of response to Humira and to direct the management of the patients Crohns disease. The test revealed a lack of antibodies and that the drug was present. However, the effectiveness of Anser ADA compared with conventional courses of action remains unproven. Patients being treated with adalimumab may experience loss of response. Loss of response can be due to multiple factors, and the appropriate method for determination of the cause for loss of response is not clear. The American College of Gastroenterology clinical guidelines for management of Crohns disease do not recommend testing for anti-drug antibody during clinical management. All told, the peer-reviewed medical literature does not suggest that the serum adalimumab testing for the amount of adalimumab and antibodies to adalimumab (Prometheus Anser ADA testing) was likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy.   Final Result: Two reviewers determined that the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld.  Credentials/Qualifications: All three reviewers are board certified in internal medicine with sub-specialty certification in gastroenterology and are actively practicing. All three reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned

A 58-year-old female enrollee has requested total hip resurfacing for the treatment of her degenerative joint disease of the right hip. Findings:  The physician reviewer found that the FDA-approval of the Birmingham Hip Resurfacing (BHR) device did not specify that the device was approved only for patients less than 55 years of age. The indications approved by the FDA are: Non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia, or inflammatory arthritis such as rheumatoid arthritis. The BHR system is intended for use in patients who, based on their relatively younger age or increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring future ipsilateral hip joint revision. This patient meets these criteria in that she is relatively young and extremely active (and therefore at an increased risk of hip dislocation with traditional hip replacement). In addition, she has osteoarthritis and is otherwise healthy, and given her life expectancy, would be expected to outlive the typical life span of a total hip replacement. Importantly, the studies on which the FDA approval is based did not show any differential outcomes related to age, and most patients in those studies were considerably older than 55 years of age.
Appeal type: Medical Necessity
Decision: Overturned

The patient is a 50-year-old female with a body mass index (BMI) of 45. The patient has multiple comorbid conditions including hypertension and hypothyroidism. Based on the submitted information, it appears the patient has undergone a psychological evaluation and has been found to be an appropriate candidate for weight loss surgery. The patient has requested authorization and coverage for gastric bypass surgery. The Health Plan indicates the requested procedure is not medically necessary for treatment of the patients medical condition.With a BMI of 45 and multiple comorbid conditions the patient meets nationally accepted medical necessity criteria for consideration of weight loss surgery. It is highly likely that gastric bypass surgery will be beneficial for this patient. Furthermore, the patient does not require further dietary workup prior to undergoing weight loss surgery. There is no scientific evidence demonstrating that structured diet or exercise plans have been successful in the treatment of the obese. In fact, the Swedish obesity study identifies that even though there may be reduction or resolution of some symptoms with diet and exercise, surgery has the longest and best long-term outcome for the obese. Therefore, I have determined that the requested procedure is medically necessary for treatment of the patients medical condition. The Health Plans denial should be overturned.
Appeal type: Experimental/Investigational
Decision: Upheld

A 20-year-old female enrollee has requested a spinal disc add-on of L5-S1 and fusion of L4-L5 surgical procedure for treatment of her L5-S1 and L4-5 degenerative disc disease and lumbar radiculopathy.  Findings:  Three physician reviewers found that the issue in this case is whether lumbar disc replacement and fusion are likely to be more beneficial for treatment of the patients severe low back and leg numbness than any available standard therapy. There is currently a paucity of data demonstrating the long-term safety and efficacy of lumbar disc replacement.  Additionally, The ProDisc-L is only FDA approved for patients with single level disease.  This patient has multi-level disease. The patient has been diagnosed with cauda equina syndrome and this diagnosis has been used as an additional justification for disc replacement. However, there is no objective evidence in the providers notes to support a cauda equina syndrome diagnosis. Even if the diagnosis of cauda equina syndrome is confirmed, the standard treatment is urgent decompression. There is no evidence that disc arthroplasty is appropriate in the setting of cauda equine syndrome. Lumbar disc arthroplasty and fusion remains of unproven efficacy at this time.
Appeal type: Medical Necessity
Decision: Upheld

A 47-year-old female enrollee has requested an MRI of the cervical spine for evaluation of her neck pain.  Findings:  The physician reviewer found that this patient has tingling of the left upper extremity and neck pain, with no focal neurological deficits noted on physical examination.  She has no personal history of cancer, and there is no history of recent trauma.  There is no clinical concern of infection.  The patient has not completed a trial of conservative care, including NSAIDs and physical therapy.  For patients with uncomplicated neck pain (this includes patients with no history of cancer, no clinical suspicion of infection, no history of recent trauma and no neurological deficits), it is medically appropriate for the patient to undergo a trial of conservative therapy, including NSAIDs and physical therapy, prior to advanced imaging such as MRI.  As there is no documentation of a recent trial of conservative therapy, and this patient has uncomplicated neck pain, the requested MRI of the cervical spine is not medically indicated for the evaluation of this patient.
Appeal type: Experimental/Investigational
Decision: Upheld

A 57-year-old female enrollee has requested assessment of emerging factors test for coronary heart disease for evaluation of her history of elevated cholesterol. Findings:  Two physician reviewers found that current guidelines do not recommend routine use of advanced lipoprotein tests because it is unclear how much incremental prognostic information is provided by these tests beyond that available from a standard lipid panel. To date, the most useful measures obtained from lipoprotein tests relate to atherogenic particle number. However, at this time, the non-HDL cholesterol or the total/HDL cholesterol ratio is of comparable predictive strength. LDL size is correlated with atherogenic particle number, but it has no clear benefit over measuring particle number in most studies to date. LDL sub-fractions measurement does contain some information regarding risk, but whether this is incremental beyond the current standard of care is unclear at this time.  In this particular patient, previous fasting lipid studies showed extremely high LDL and severely low HDL, necessitating intensification of statin therapy with continuation of high dose niacin and adding other potentially useful agents. As such, and given the other known baseline coronary risk factors (hypertension hyperlipidemia and post-menopausal state), there is no additional diagnostic or prognostic information to be gained by the requested testing.  This patient is already at high risk for a cardiovascular event due to the presence of multiple traditional risk factors. All told, assessment of emerging risk factors for coronary heart disease is not likely to be more efficacious than alternative methods of evaluation.
Appeal type: Medical Necessity
Decision: Upheld

The patient is a 63-year-old female with multiple medical problems including bipolar disorder and severe osteoarthritis. She was hospitalized in April 2006 for urosepsis complicated by acute renal failure and lithium toxicity. The patient was encephalopathic and had peripheral neuropathies during her acute stay. Her cognitive functioning improved but she had slow recovery of motor function. The patient was admitted to the skilled nursing facility (SNF) for rehabilitation in May 2006. She made good progress initially, but her progress slowed over the final two to three weeks of occupational therapy (OT) and physical therapy (PT).  Her therapists noted her osteoarthritis as contributing to her limited progress.  PT and OT services were discontinued in June 2006.  The patient and her representative have requested authorization and coverage for continued skilled nursing services.  The Health Plan denied the request citing a lack of medical necessity after June 2006.Review of the submitted clinical evidence demonstrates the patient had met her OT goals related to ADLS by week ending June 2006. She did show some increase in strength, but her functional progress was noted to be limited by her knee pain. The PT progress notes indicate limited progress in bed mobility, transfers and ambulation after week four.  It is also noted that weight bearing and ambulation were limited by her osteoarthritis. It appears that by June 2006 the patient had maximized her functional status and would not benefit further from continued inpatient skilled rehabilitation. Therefore, I have determined that continued skilled nursing facility services after June 2006 were not medically necessary for treatment of the patients medical condition. The Health Plans denial should be upheld.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary:   The parent of an enrollee has requested magnetic resonance imaging (MRI) of the brain with and without contrast and MRI of the sella turcica with and without contrast for evaluation of the enrollees structural abnormalities possibly related to hypotonia and developmental delay.  The physician reviewer found that this patient presents with well documented developmental delays which supports the medical necessity for MRI imaging. Additionally, his specific neurological examination of hypotonia and delayed development suggests that the patients cerebellum may be abnormal. To determine the structural integrity of the cerebellum is by MRI imaging. This patient also has multiple minor facial anomalies which would significantly increase the possibility of an abnormal cerebral MRI. The standard of care for assessing a child with unexplained developmental delay includes a careful developmental assessment, a complete neurological examination, a comparative genetic microarray and a cerebral MRI.  However, the MRI views of the sella turcica are not medically necessary. Typically, in the clinical setting of an elevated TSH and a normal T4, the common anomaly is an aberrant thyroid, and a thyroid scan would be indicated.  For the reasons provided, the MRI of the brain with and without contrast is medically necessary. However, the request for an MRI of the sella turcica is not clinically indicated.   Final Result: The reviewer determined that a portion of the requested services are medically necessary for evaluation of the patients medical condition. Therefore, the Health Plans denial should be partially overturned.  Credentials/Qualifications: The reviewer is board certified in pediatrics and child neurology with sub-specialty certification in neurodevelopmental disabilities and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Experimental/Investigational
Decision: Overturned

The husband of a 60 year old female enrollee has requested two positron emission tomography (PET) scans for an evaluation of the enrollees metastatic lung cancer. Findings:  Three physician reviewers found that for this patient, restaging with PET/CT was imperative to her treatment planning. The outcome of the PET scans allowed appropriate treatment planning. Standard imaging (CT, MRI) would not have provided adequate clinical information for treatment planning for this patient. The diagnostic procedures at issue were likely to be more beneficial for evaluation and treatment of this patients medical condition than any available standard therapy.
Appeal type: Experimental/Investigational
Decision: Overturned

A 34-year-old female enrollee has requested NeuroStar transcranial magnetic stimulation (TMS) therapy for treatment of her major depressive disorder.  Findings:  Two physician reviewers found that this patient was suggested for transcranial magnetic stimulation (TMS) therapy by her treating psychiatrist due to her failure to respond to conventional treatments. She was provided TMS therapy on several dates during the said timeframe, and has refractory depression and had been undergoing treatment with many medications and psychotherapy for which she reported suboptimal results. She was recommended for TMS therapy which was approved by the FDA for the treatment of refractory depression. Moreover, TMS is considered a viable alternative to electroconvulsive therapy (ECT) or vagal nerve stimulation (VNS). This patient has documentation demonstrating failure of different categories of antidepressant medications and continued to experience depressive vegetative symptoms. As such, the TMS therapy provided was the next logical step in her treatment and likely to be more beneficial than any conventional alternative.
Appeal type: Medical Necessity
Decision: Overturned

The patient is a 58-year-old female with a history of multiple cancers. In 1991, she was diagnosed with breast cancer and underwent bilateral mastectomies followed by chemotherapy. In 1993, she underwent hysterectomy and bilateral oophorectomy for a mucinous adenocarcinoma of the ovary. This was followed by intravenous as well as intraperitoneal chemotherapy. In 1996, she was found to have melanoma in situ of her back, which was widely excised. In May 2004, she was found to have cancer in the head of the pancreas, which was not resectable. Notes indicate the patient has a maternal great aunt with breast cancer and a maternal cousin with breast cancer. The patient seeks to have BRCA testing to determine if she carries a mutation of that gene, for which her two daughters could be tested for and their medical management affected.BRCA testing is a means of determining whether a patient carries a gene mutation. Carriers of a mutation have an extremely high risk of developing both breast cancer and ovarian cancer. Patients found to have such a mutation often consider preventive surgical removal of ovaries and/or breasts. Women felt to be at significant risk of carrying the mutation are either from families with a strong history of first-degree relatives with breast and/or ovarian cancer at a young age or who themselves have developed breast and/or ovarian cancer at a young age. This patient developed breast cancer at age 45 and ovarian cancer at age 47. Even without a strong family history the patient qualifies for consideration of BRCA testing. Although testing will not impact the patients treatment, it may have a significant impact on the patients daughters and other family members. Furthermore, although the patients daughters are still under the age of 21 and it would controversial as to whether the daughters should be tested in the near future because it would be highly unlikely that oophorectomy or mastectomy would be recommended at their ages, it is medically reasonable and appropriate for the patient to undergo the requested testing as it will provide significant future value for her daughters.Based upon the information set forth above, I have determined the requested testing is medically necessary for evaluation of the patients medical condition. Therefore, the Health Plans denial should be overturned.
Appeal type: Medical Necessity
Decision: Upheld

A 54-year-old female enrollee has requested Subsys for treatment of her interstitial cystitis.  Findings:  The physician reviewer found that Subsys is not medically necessary for the patients medical condition. Subsys is indicated for breakthrough cancer pain in patients who are opioid tolerant or otherwise with a limited life expectancy. In addition, the patient reportedly failed previous trials of multiple opioids including fentanyl citrate, which is the same opioid known as Subsys. Opioids are considered adjunctive to this therapy and short-release medications with a high risk of dependence and tolerance such as Subsys is not recommended. High dose opioids may also cause adverse outcomes. Ballantyne and Mao reported on studies indicating that prolonged use of high dose opioids may induce tolerance, abnormal pain sensitivity, and hormonal effects. Baron and McDonald reported that high dose opioids may contribute to pain sensitization via opioid-induced hyperalgesia, decreasing patient pain threshold and potentially masking resolution of a preexisting pain condition. All told, it is in this patients best interest to wean off opioids and be provided adjunctive therapy such as physical therapy, massage therapy, aqua therapy or cognitive behavioral therapy, in order to address the patients chronic pain. Therefore, the requested Subsys is not medically necessary for treatment of this patients medical condition.