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

A 45-year-old female enrollee requested authorization and coverage of surgery with a non-contracted surgeon for treatment of bilateral mastectomies.  The health plan denied the enrollees request indicating that it is not medically necessary for the enrollee to undergo surgery with a non-contracted surgeon.One physician reviewer performed a medical necessity Independent Medical Review.  The physician reviewer upheld the health plans denial on the basis that the requested procedure is not medically necessary.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Stelara. Findings: Current medical literature supports dose escalation of Stelara to 90 mg every four weeks in this case. One study reports in a double-blind, placebo-controlled trial of ustekinumab as induction and maintenance therapy for ulcerative colitis that a single intravenous dose of Stelara induced clinical remission in a significantly greater proportion of patients than placebo did, as measured by both clinical response and endoscopic response. Another study notes that dosing at 90 mg every four weeks was used frequently to address inadequate disease control, and a large proportion of patients were able to maintain response with dose escalation to 90 mg every four weeks. Multiple studies have shown that a majority of patients in whom Stelara dosing every eight weeks failed to control symptoms responded to dosing every four weeks. Another study reports that while ustekinumab is effective for the treatment of ulcerative colitis, over 40% of patients have suboptimal clinical response after induction and maintenance dosing every eight weeks, and that many of these patients undergo empiric dose intensification. In this case, the patient has moderate-to-severe ulcerative colitis and has failed multiple conventional therapies. The patient had initial improvement on Stelara but laboratory testing showed a low Stelara level when dosed every eight weeks, with active disease symptoms. Continuation of dosing at every eight weeks or discontinuation of Stelara may result in loss of toxic megacolon, dysplasia leading to colorectal cancer, flare, hospitalization, need for surgery, or other complications. Therefore, Stelara is medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested medication regimen 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 internal medicine with sub-specialty certification in gastroenterology 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

The parent of a two-year-old female had requested speech therapy for treatment of her severe expressive language impairment.  Findings:  The physician reviewer found that the patient had a profound deficit in her expressive language skills when she was tested at the age of 18 months. The patients scores on standardized objective testing were significantly below average. The submitted documentation demonstrates the patient made significant improvements in her speech, from being a non-speaker to being only 28% delayed after 4 months of speech therapy, which confirms the validity of the effectiveness of speech therapy for speech delayed children.   The common practice of the medical community is to refer a speech-delayed child to a speech therapist to develop speech. There is a robust body of medical literature supporting speech therapy in this population. Children with speech delay can be readily treated (Law, et al.) and cognitively normal children are ideal candidates for successful speech therapy (Goorhuis-Brouwer and Kniff). Speech therapy has been found to be efficacious in the treatment of speech delays in young children (Emmanuel, et al.). Thus, it is medically necessary and appropriate for this patient to continue to receive speech therapy. Given the patients previous gains, it is likely that she will continue to benefit from additional therapy.
Appeal type: Experimental/Investigational
Decision: Upheld

The parent of a nine-year-old male enrollee has requested biofeedback therapy for the treatment of the enrollees attention deficit hyperactivity disorder. Findings:  Two physician reviewers found that this patient has a history consistent with ADHD but the records do not document use of pharmacologic therapy for management of his condition. A review of the relevant medical literature demonstrates that stimulants, such as methylphenidate, are considered first-line therapy for young patients with ADHD. In trials of medications with or without behavioral therapy, patients with ADHD who received treatment with stimulant medications showed the greatest improvement in behavior when compared to other interventions such as behavior therapy or family counseling. Research in prospective controlled studies show potential improvements in patients with ADHD treated with neurofeedback in attention, anxiety, and impulsivity and indicate a combination of both stimulant medication and behavior therapy demonstrate synergistic efficacy. Neurofeedback alone has not been shown to be more effective than standard therapies for ADHD.
Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Keytruda infusions (pembrolizumab). This patient presents with thyroid cancer, for which the standard of care includes dabrafenib and trametinib based on the presence of a BRAF V600E mutation (Subbiah, et al.). The provider recommended the addition of Keytruda in combination with the BRAF targeted therapy. Keytruda is U.S. Food and Drug Administration (FDA) approved for various tumor indications. The National Comprehensive Cancer Network (NCCN) guidelines support treatment with Keytruda for patients with microsatellite instability-high or mismatch repair deficient cancer. This patient underwent testing to assess for BRAF mutations. However, the patients tumor mutational burden was not quantified or reported. Overall, there is a paucity of prospective randomized controlled trials demonstrating that Keytruda provides substantial improvement over standard available treatment options in this patients clinical scenario (Iyer, et al.). Therefore, the requested Keytruda infusions (pembrolizumab) are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Findings:  Two of the three physician reviewers found the requested Keytruda infusions (pembrolizumab) are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the requested medication is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: Physician reviewer 1 is board certified in internal medicine with subspecialty certifications in medical oncology and hematology and is actively practicing. Physician reviewer 2 is board certified in internal medicine with subspecialty certifications in medical oncology and hematology and is actively practicing. Physician reviewer 3 is board certified in internal medicine with subspecialty certification in medical oncology and is 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

Nature of Statutory Criteria/Case Summary: The parent of an enrollee has requested authorization and coverage for 108 hours per month of one-on-one applied behavioral analysis (ABA) and 13 hours per month of supervision. Findings:  The physician reviewer found that there is sufficient peer-reviewed literature supporting the correlation between treatment outcomes and treatment intensity for children with autism. In this case, the patient has made progress in many areas over the last several years, but he continues to demonstrate impairment in several areas including aggression and self-injury. The Health Plan has authorized approximately 17 hours per week of direct ABA therapy. Several studies recommend 25 or more hours of weekly ABA to ensure optimal outcomes. Given the patients increasing behaviors of self-injury and aggression, the request for 108 hours per month of direct ABA and 13 hours per month of supervision are medically necessary for treatment of the patients medical condition. Final Result: The reviewer determined that the requested services are medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The physician reviewer is board certified in pediatrics with sub-specialty certification in developmental-behavioral pediatrics 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 40-year-old female enrollee has requested continuation of Remicade infusions for the treatment of her rheumatoid arthritis.   Findings:  The physician reviewer found that the submitted documentation establishes the medical necessity of the requested services. Remicade (infliximab) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of rheumatoid arthritis. It is generally given with methotrexate, as in this case. The accepted protocol for Remicade infusions is to administer infusions at 0, 2, and 6 weeks at a dose of 3mg/kg body weight followed by infusions every 8 weeks. If there is no improvement, then the dose may be increased to 10mg/kg or the dosing interval may be decreased to every 4 weeks. This dosing flexibility allows the treating rheumatologist to tailor the treatment to the individual patients needs, based on the number of tender and swollen joints on physical exam (Westhovens et al). In this case, the patient has not had an adequate trial of the medication and still has active disease. Thus, stopping Remicade at this point does not meet generally accepted standards of care in the treatment of rheumatoid arthritis. Therefore, the requested continuation of Remicade infusions is medically necessary for treatment of the patients medical condition.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patients parent has requested authorization and coverage for Exondys 51. Findings:  The physician reviewer found that Exondys 51 is an exon 51 skipping agent that has been demonstrated to increase dystrophin in muscle and increased muscle strength. Exondys 51 received U.S. Food and Drug Administration (FDA) approved for the treatment of patients with Duchenne muscular dystrophy (DMD) who have a confirmed mutation of the dystrophin gene amenable to exon 51 skipping. The FDA does not require the ability to ambulate as a requirement for treatment. In this case, the patient has preserved strength in the bilateral upper extremities. In addition, his cardiac and pulmonary function are preserved. He would benefit from Exondys 51 to increase muscle dystrophin, delay upper extremity progression and slow the decline of cardiac and pulmonary function. Exondys 51 may also delay the use of pulmonary support. Therefore, Exondys 51 is medically necessary for treatment of this patient. 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 neurology with subspecialty certification in neuromuscular medicine and expertise in pediatric 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: Upheld

Nature of Statutory Criteria/Case Summary:An enrollee has requested reimbursement for a wearable cardioverter defibrillator (Zoll LifeVest) or treatment of the enrollee who has a history of hypertrophic cardiomyopathy. Findings:  The physician reviewer found that The benefits of the wearable cardiac defibrillator (WCD) have been the subject of intensive study. Moreover, WCD has not been a proven benefit for newly diagnosed patients with cardiomyopathy. Guidelines of the Heart Rhythm Society (HRS) and the American College of Cardiology (ACC) do not support use of the WCD. Instead, the guidelines recommend permanent ICD after a waiting period of 45 to 90 days if potentially reversible causes are present but the WCD has not been proven beneficial in this situation. There is a lack of randomized trial, which have shown the benefits of WCD over and above that of optimized medical therapy. The medical literature recommends further study of the use of this equipment. Based on this data, the wearable cardioverter defibrillator from 11/2/17 through 1/2/18 was not likely to have been more effective than the available standard methods for the treatment of this patients medical condition. Final Result: Three reviewers determined that the equipment at issue was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: Physician reviewer number one is board certified in internal medicine with sub-specialty certification in cardiovascular disease 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.Physician reviewer number two is board certified in internal medicine with sub-specialty certification in cardiovascular disease 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.Physician reviewer number three is board certified in internal medicine with sub-specialty certification in cardiovascular disease 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 70-year-old female enrollee has requested Procrit injections for the treatment of her anemia. Findings:  The physician reviewer found that this patient has multiple co-morbidities and has chronic normocytic anemia. The iron indices strongly indicate that the anemia is probably not due to iron deficiency. It is more likely due to chronic disease like chronic lower extremity infection. The patients ferritin level was 69 ng/mL and most studies performed in patients with chronic inflammatory conditions show that a level under 60ng/mL has a predictive value of 84% for iron deficiency anemia (Cook and Hansen, et al.). The Health Plan indicated that the patients iron stores need to be adequate in order for her to receive Procrit and that iron stores are measured by a transferring saturation of at least 20% or a serum ferritin of at least 80ng/mL. The ferritin level of 80ng/mL is an exceedingly high cutoff value for adequate iron stores. A high ferritin cutoff of 60ng/mL is used in the setting of an inflammatory condition. Ferritin is an acute-phase reactant which becomes elevated in conditions such as rheumatoid arthritis and cancer. Upon review of this patients hemoglobin, it appears that she has previously responded well to Procrit. Procrit is medically appropriate in anemia of chronic disease especially if the patient could be hemodynamically compromised by repeated blood transfusions (Pincus, et al). This patient has been managed with Procrit injections administered by a nurse and should continue to be maintained on Procrit therapy on an as-needed basis with periodic testing to ensure that her transferrin saturation is at 20% or above.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary:   An enrollee has requested continued skilled nursing for treatment of his medical condition. Findings:  The physician reviewer found that based on the clinical documentation submitted for review, the medical necessity for skilled nursing services has not been established. In this case, the patient has requested continued skilled nursing services after a stroke. His functional mobility, self-care, communication, and swallowing are profoundly affected. The patient has been treated with intensive inpatient rehabilitation services and continues to require tube feedings, and is dependent for mobility and self-care. The patient sustained a stroke, and his pace of recovery will be slower now than closer to the time of stroke. He has made minimal progress thus far. Further significant functional improvement with inpatient therapies is not likely. In addition, skilled nursing services are not supported by the medical literature or by the patients recovery trajectory. All told, continued skilled nursing services were not and are not medically necessary for treatment of the patients medical condition.  Final Result: The reviewer determined that the services at issue were not and 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 physical medicine and rehabilitation 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

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for bilateral digital breast tomosynthesis performed for evaluation of the enrollee, who was asymptomatic. Findings:  The 3 physician reviewers found that breast tomosynthesis is a technique that was developed several years ago as a problem solving adjunct to routine mammography.  Applying the same basic concept as computed tomography (CT) scanning, the logic is that by separating the various layers of breast tissue, one can better detect abnormalities.  This has been shown to be most useful in the evaluation of dense breasts.  In this patients case, the records noted dense breast tissue.  It is specifically those patients who have dense breasts that can benefit most from tomosynthesis.  The ability to separate out the overlapping structures enables the possibility of demonstrating an otherwise occult tumor.  Thus, bilateral digital breast tomosynthesis performed was likely to have been more effective than other methods of evaluating this patient. Final Result: The 3 reviewers determined that the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: Physician reviewer number one is board certified in diagnostic radiology 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.Physician reviewer number two is board certified in diagnostic radiology 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.Physician reviewer number three is board certified in diagnostic radiology 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 39-year-old male enrollee has requested 20 mg of Ambien, prescribed nightly for treatment of his chronic persistent insomnia. Findings:  The physician reviewer found that this patient was tried on FDA-approved medications for insomnia, and these were not effective. His condition falls into a category of chronic insomnia that has been very recalcitrant to treatment. Current treatment options do not address the needs of difficult-to-treat patients with chronic insomnia, such as the elderly, and those with co-morbid medical and psychiatric conditions (Benca). Sleep and insomnia have been well studied as related to their effect on mood and psychiatric illness. Lack of sleep is well documented to have a deleterious effect on mood. Insomnia is frequently co-morbid with depression, and observational studies suggest that insomnia is a high risk factor for depression. Disturbed sleep is of particular concern in patients with depression, as it can aggravate the symptoms of depression and influence the treatment response to anti-depressants (Wade). Based on the documentation provided, it is apparent that the Ambien 20 mg dose is the only treatment that has been effective for this patients chronic insomnia over the years. Although the requested dose is above the FDA recommended maximum, there appears to be no adverse effects or contraindications to this dosage based on the information provided. While the routine use of Ambien 20 mg nightly for chronic insomnia has not been widely studied, this dosage has been used in some studies and there is little evidence that a 20 mg dose of Ambien has any contraindications due to safety or tolerability issues (Harrison and see Holm). In summary, due to this patients poor response to alternative medications in the past and his success with Ambien 20 mg nightly, I have determined that the medication at issue was and is medically necessary for treatment of the patients medical condition.