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

A 53-year-old female enrollee has requested Orencia infusions with an initial loading dose (three infusions over four weeks) followed by a maintenance dose of 750 mg intravenously (IV) every four weeks for treatment of her rheumatoid arthritis.  Findings:  The physician reviewer found that there is a lack of guidance provided in the peer-reviewed literature, the American College of Rheumatology guidelines and the manufacturers prescribing highlights of how to dose Orencia when there a break in treatment.  According to Orencias packaging insert, the half-life of Orencia is 8-25 days with a terminal half-life of 13 days. Typical pharmacodynamics would suggest that this medication would be eliminated within 4-5 half-lives which could be from 32-125 days with an average of 52-65 days. Given that the patient has not reached the 65 days, there may still be Orencia in her body putting her at risk of overdosing and infections if she were to be re-loaded. Westhovens and colleagues evaluated the safety and efficacy of abatacept plus methotrexate (MTX) over five years in patients with rheumatoid arthritis. The authors found long term safety allowed interruptions of up to two infusions (12 weeks) between treatments without re-loading the patients for safety issues. Since it has been only eight weeks since her last infusion, she does not require re-loading. Moreover, given that according to her most recent exam, Orencia has not put her in remission and there is discussion of stopping it, the risk of re-loading outweighs the risk of restarting at her current monthly dose as approved by the Health Plan. In sum, the request for re-loading may place the patient at risk of overdosing or serious infections, making the requested Orencia infusions with an initial loading dose (three infusions over four weeks) followed by a maintenance dose of 750 mg IV every four weeks as not medically necessary. Based on the documentation submitted for review and the peer-reviewed literature cited above, the requested services are not medically necessary for treatment of the patients medical condition.
Appeal type: Medical Necessity
Decision: Overturned

A 26-year-old male enrollee has requested a referral to a physical medicine and rehabilitation and pain management physician for the treatment of his lower back pain. Findings:  The physician reviewer found that diagnostic medial branch blocks under fluoroscopic guidance have been validated as sensitive and specific for the diagnosis of facet generated pain. In the setting of a positive response to a medial branch block, radiofrequency neurotomy can be considered for long-term pain relief. Lumbar medial branch neurotomy is an effective means of reducing pain in patients carefully selected on the basis of controlled diagnostic blocks. While this patients physical exam may suggest facetogenic pain, the studies demonstrate no particular set of signs or symptoms as typical for this condition. All told, the planned course of action appears medically appropriate and indicated. Furthermore, given the location of the tertiary center, the referral recommended by the Health Plan is contraindicated as it is likely to result in increased back pain associated with travel to and from the facility.
Appeal type: Medical Necessity
Decision: Upheld

The enrollee is requesting reimbursement for behavioral health residential treatment center level of care. The enrollee has a medical history of depression, anxiety, and unspecified personality disorder and entered residential treatment. The reason for admission included treatment resistance, as evidenced by a failure of efforts to provide treatment on an outpatient basis in the past; with and without medication. The enrollee had passive death wishes without suicide plan or intent, but only when his pain was very severe. The enrollee indicates he had been suffering from depression for many months. Neither his subjective well-being nor his level of functioning was improving. He was concerned he would continue to need frequent psychotherapy indefinitely to avoid getting worse. At the residential treatment center, he felt confident about improving sufficiently to return to a life path that includes his most important personal and vocational goals. The enrollee has received regular outpatient psychological and psychiatric treatment without success. His therapist recommended residential psychological treatment because he believed outpatient treatment was not leading to improvement in the enrollees condition. The medical literature indicates the psychiatrist should determine the least restrictive setting for treatment that will be most likely not only to address the enrollees safety, but also to promote improvement in the enrollees condition. The determination of an appropriate setting for treatment should also include consideration of the enrollees ability to adequately care for himself, provide reliable feedback to the psychiatrist and cooperate with treatment of major depressive disorder. Randomized controlled trials have shown that residential care may provide an efficacious short-term alternative to inpatient care for voluntary enrollees with urgent behavioral health conditions. The provider noted the enrollee had an emotional disconnect, mood was depressed and affect restricted. Although the enrollee had significant deterioration in function, which had been unresponsive to an appropriate course of treatment at a less intensive level of care, the records failed to support the enrollee could not have been treated at a lower level of care. There is insufficient evidence in the record the enrollee was a threat to himself or others. Medical evidence does not support the services at issue in this clinical setting. Final Result: The reviewer determined that the requested services are not medically necessary for the treatment of the enrollees medical condition. Credentials/Qualifications: The physician reviewer is board certified in psychiatry 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 similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Xyosted.Findings: Male hypogonadism is a clinical syndrome that results from failure to produce physiological concentrations of testosterone, normal amounts of sperm, or both. Hypogonadism may arise from testicular disease (primary hypogonadism) or dysfunction of the hypothalamic-pituitary unit (secondary hypogonadism). Xyosted is FDA approved for the treatment of hypogonadism. Guidelines support the use of testosterone enanthate for the treatment of hypogonadotropic hypogonadism. In this case, the patient has hypogonadotropic hypogonadism and they have tried injection testosterone cypionate without much improvement in symptoms. The patient also has declined topical therapy out of concern for the risk of exposure to their spouse and children. The patient has tried samples of Xyosted and he reported that the Xyosted had improved results compared to injection testosterone cypionate. Under these circumstances, the requested medication, Xyosted, is medically necessary for the patients medical condition.Final Result: The reviewer determined that the requested medication is medically necessary for the patient's medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer is board certified in urology 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: Upheld

A 54-year-old female enrollee has requested coronary computed tomography angiography (CCTA) for evaluation of her chest pain. Findings:  Two physician reviewers found that the patient has some cardiac risk, ongoing symptoms of atypical chest discomfort, and prior negative cardiac evaluation, including a calcium score of 0, a normal nuclear stress test and a normal echocardiogram. In this setting of a recent negative cardiac evaluation, including an unequivocally normal nuclear stress test, CCTA is not medically indicated and is not considered a superior diagnostic modality. If the patient has ongoing symptoms suspicious for coronary ischemia in spite of negative noninvasive evaluation, then conventional coronary angiography may be considered and is preferred given its improved accuracy relative to noninvasive CCTA and the ability to intervene with percutaneous revascularization during the same procedure, if clinically indicated. Current guidelines that are endorsed by several national organizations do not consider CCTA appropriate or indicated in this circumstance of an unequivocally normal nuclear stress test.
Appeal type: Medical Necessity
Decision: Overturned

A 29-year-old female enrollee has requested continued inpatient psychiatric care for treatment of her schizophrenia, paranoid type with auditory command hallucinations.  Findings:  The physician reviewer found that since she still is not able to care for herself at this time, although she is showing slow progress, she meets the continued stay criteria for inpatient level of care. Her inability to care for herself is directly caused by her mental illness and acute deterioration. She has been compliant with medications, she was showing slow but steady improvement, and there is a reasonable expectation that she would return to her previous level of functioning so that she could return to live in her former placement. All told, the inpatient psychiatric services provided to this patient from said date and forward are supported as medically necessary for treatment of her medical condition.
Appeal type: Medical Necessity
Decision: Overturned

The patient is a 54-year-old male who has been managed by a dermatologist for psoriasis. He has had a documented excellent response to Raptiva under conditions of a clinical trial. He would like to continue to receive Raptiva. Light therapies are contraindicated because of his history of skin cancer. Other medications are contraindicated because of increased lipids. The patient is reluctant to use cyclosporine or methotrexate because of their toxicities. The Health Plan indicates the patient must fail a trial methotrexate or cyclosporine before Raptiva can be authorized.Because of the respective liver and kidney toxicities, neither methotrexate nor cyclosporine are reasonable long-term therapies for this patients chronic condition. Furthermore, Raptiva has already demonstrated efficacy in treating this patients condition. For the above reasons, it is reasonable for the patient to forego a trial of methotrexate or cyclosporine and continue with Raptiva therapy. Raptiva is medically appropriate and necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.
Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the DecisionDx-Melanoma Genetic Testing. The DecisionDx-Melanoma Genetic Testing claims to determine risk of recurrence for early melanoma stage I and stage II. However, in stage I and II melanoma, there is a lack of data to support using adjuvant therapy regardless of recurrence risk. Hence, the use of genetic testing to help determine the risk of recurrence is of limited value. In addition, the follow-up of melanoma patients, regardless of the risk of recurrence is standard and is summarized in National Comprehensive Cancer Network (NCCN) guidelines. The NCCN guidelines state that the follow-up of melanoma patients is not tailored to each patient, rather global to all patients with melanoma. For these reasons, the DecisionDx-Melanoma Genetic Testing was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.Findings:  Three physician reviewers found the DecisionDx-Melanoma Genetic Testing was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the DecisionDx-Melanoma Genetic Testing was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.Credentials/Qualifications: Physician reviewers 1, 2 and 3 are board certified in internal medicine with sub-specialty certification in medical oncology and are actively practicing. The 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 twenty-five year-old female with a history of bulimia nervosa is requesting reimbursement for residential treatment services.Reviewers Findings:The reviewing physician found that the patient appears to have been greatly compromised by her eating disorder.  The reviewing physician found that the Health Plan denial should be overturned.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary:   An enrollee has requested a Flexitouch pneumatic compression device and lower garments for treatment of his medical condition.  Findings:  The physician reviewer found that the requested Flexitouch pneumatic compression device and lower garments are not medically necessary for treatment of the patients medical condition. The principal therapy for confirmed cases of lymphedema is skin care, the use of compression garments, intensive bandaging and lymphatic massage. Complete decongestive physiotherapy is a highly effective treatment for both primary and secondary lymphedema. The initial reductions in volume achieved are maintained in the majority of the treated patients. This management of lymphedema includes three phases: an initial treatment that aims to reduce volume of the lymphedema, a maintenance phase to maintain the result and lastly, a withdrawal phase. These therapies approach a 70% reduction in edema burden and in compliant patients success is maintained in greater than 80%. In this case, the patient presents with lymphedema, however there is no evidence of manual drainage or non-programmable lymphedema usage. In addition, there is no documentation of scarring contracture or sensitive skin. Given the lack of documentation of conservative treatments tried and failed, the requested for a Flexitouch pneumatic compression device and lower garments has not been established as medically necessary for treatment of the patients medical condition.  Final Result: The reviewer determined that the requested services are 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 vascular surgery 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: Medical Necessity
Decision: Overturned

Findings:  The physician reviewer found that an enrollee has requested authorization and coverage for a Humira Pen Injection kit. Current medical literature supports the use of Humira for the treatment of psoriasis and psoriatic arthritis (PsA). Anti-TNF (anti-tumor necrosis factor) agents have been proven very effective for PsA and are disease modifying agents. They prevent progression of disease, erosions and disability and are thus the preferred agent for PsA. In regards to treatment of psoriatic arthritis and TNF inhibitor (TNFi), there are multiple studies and international guidelines recommending their use. The recent recommendations involved a systematic literature review of 25 papers and 12 abstracts, and this review confirmed the efficacy of TNFi in PsA. In this case, given the patients age, sex and desire for pregnancy, methotrexate and leflunomide would be contraindicated. Both of these agents are pregnancy category X per FDA labeling. The guidelines and medical literature support Humira use for the treatment of psoriasis and psoriatic arthritis. Accordingly, the request for Humira Pen Injection kit is medically necessary for treatment of the patients medical condition.Final Result: The reviewer determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer is board certified in allergy and immunology and internal medicine, with subspecialty certification in rheumatology, 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: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for oxycodone HCl 30 mg IR (immediate release) tablets, 270 tablets per 30 days. The Centers for Disease Control and Prevention (CDC) guidelines for the prescribing of opioids for chronic pain state that providers should evaluate benefits and harms of continued therapy with patients every three months or more frequently. If benefits do not outweigh harms of continued opioid therapy, clinicians should optimize other therapies and work with patients to taper opioids to lower dosages or to taper and discontinue opioids. Similarly, the Federation of State Medical Boards guidelines state that, Continuation, modification or termination of opioid therapy for pain is contingent on the clinicians evaluation of (1) evidence of the patients progress toward treatment objectives and (2) the absence of substantial risks or adverse events, such as signs of substance use disorder and/or diversion. In this case, the patient was diagnosed with CRPS after being injured in a dog attack. Her treatment planning has included pain management, which recommended ganglion blocks and opioid therapy. She has also received ketamine infusions in the past with short-term benefit. The records do not document usage of pain scores demonstrating at least 30% analgesic benefit with her medication regimen or signs of validated functional assessment scales to support functional improvement. In addition, there is a lack of regular urine drug screens as recommended by national guidelines. The notes from December 2019 suggest that the patient has experienced side effects of constipation and abdominal pain, likely due to high-dose opioid therapy. Based on the available medical records for review and current guidelines, abrupt discontinuation of high-dose chronic opioid therapy would place this patient at risk for symptoms of withdrawal. Given these findings, oxycodone 30 mg every eight hours as needed, 90 tablets per days, is medically necessary for treatment of this patient. Final Result: The reviewer determined that a portion of the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be partially overturned. Credentials/Qualifications: The reviewer is board certified in anesthesiology with subspecialty certification in pain management 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: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary:  An enrollee has requested Norco for treatment of her fibromyalgia. Findings:  The physician reviewer found that based on the clinical documentation submitted for review, the medical necessity for Norco has not been established. According to the documentation submitted for review, the patient is requesting 1-2 tablets of Norco daily. Such narcotics and at the doses prescribed is presently indicated for severe cancer pain in patients who are opioid tolerant and with a limited life expectancy. Additionally, the dose of Norco poses a risk for acetaminophen toxicity. This patient has non-malignant chronic pain, which will often worsen or recur as a result of opioid rebound. Current standard of care for chronic pain is treatment in a multidisciplinary practice to include physical therapy, massage therapy, cognitive behavioral therapy, and injections to help reduce pain. Moreover, the medical literature reported that high dose opiates might contribute to pain sensitization via opioid-induced hyperalgesia, decreasing patient pain threshold and potentially masking resolution of a preexisting pain condition. In this retrospective study, the majority of patients undergoing detoxification of high dose opiates for chronic pain reported a significant decrease in pain at the end of the study, further supporting the theory of opioid-induced hyperalgesia. For the reasons provided, the patients request for Norco is not medically necessary. Final Result: The reviewer determined that the requested medication 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 anesthesiology with sub-specialty certification in pain 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: Medical Necessity
Decision: Overturned

A 59-year-old female enrollee has requested Alimta (pemetrexed) to be administered in combination with Avastin for the treatment of her lung cancer. Findings:  The physician reviewer found that clinical trials have shown that pemetrexed has activity in metastatic lung cancer following prior chemotherapy. The study cited above suggested a benefit at six months for patients treated with Avastin and Alimta (Weiss, et al.). This was not a prospective trial and included only nine patients treated with this combination. Still, the results are encouraging and have prompted other studies. More recently, a phase II multicenter, randomized trial comparing chemotherapy alone with bevacizumab and chemotherapy (docetaxel or pemetrexed) or bevacizumab and erlotinib. This trial showed that the addition of bevacizumab was beneficial in terms of both progression-free survival and overall survival (Herbst, et al.). Currently, there is no standard of care in the treatment of metastatic NSCLC. However, these two trials provide a sound rationale for the use of Avastin and Alimta in combination. Additionally, each of these agents are known to be active in NSCLC when used alone, and their combined use is clinically reasonable at this stage.