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

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Tramadol Hcl 50 mg quantity 60 with one (1) refill for treatment of radiculopathy, somatic dysfunction, and osteoarthritis. Findings:  The physician reviewer found that guidelines offer specific requirements for the ongoing use of opiate pain medication to treat chronic pain. Recommendations state the lowest possible dose be used as well as ongoing review and documentation of pain relief, functional status, appropriate medication use and its side effects. Documentation of the patients response to pain medication should include the duration of symptomatic relief, functional improvements, and the level of pain relief. However, this patients records do not demonstrate that treatment with Tramadol did or will decrease the level of pain the patient reported from one visit to the next. In addition, there was no noted functional improvement or improved pain noted during the duration of the prescription for Tramadol. There is no indication that the patient has failed or has a contraindication to first-line agents such as non-steroidal anti-inflammatory drugs (NSAIDs). 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 neurology 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: Experimental/Investigational
Decision: Upheld

A 47-year-old female enrollee has requested Botox injections for treatment of her headaches. Findings:  Three physician reviewers found that no indication is given regarding headache frequency, number of headache days per month, headache severity, degree of disability, or prior preventive or abortive medications tried. The submitted documentation does not include duration or results from prior medication trials.  The patient has been diagnosed with refractory migraine, with little information regarding headache frequency or severity, or details regarding previously tried and failed standard preventives.  As there is no confirmation that the patient has already failed standard preventives, nor that she has chronic migraine, the superior efficacy of Botox injections has not been established in this patients case.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee is requesting authorization and coverage for the medication Qsymia. According to the Food and Drug Administration, Qsymia is approved as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition. The initial management of individuals who would benefit from weight loss is a comprehensive lifestyle intervention, which would include a combination of diet, exercise, and behavioral modification as noted by studies. All patients who would benefit from weight loss should receive counseling on diet, exercise, and goals for weight loss. When a patient with a BMI greater than 30 kg/m2 or a BMI of 27-29.9 kg/m2 with comorbidities, such as hypertension or diabetes mellitus, has failed to achieve weight loss goals through diet and exercise alone, then pharmacologic therapy is suggested. In this case, the documentation does not support that the patient has failed treatment with counseling, calorie restriction and increased physical activity to achieve weight loss goals. There are also no studies that reflect Qsymia to be more effective than generic phentermine, benzphetamine, diethylpropion, and phendimetrazine. Therefore, the requested medication, Qsymia, is not medically necessary to treat the patients medical condition.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 internal 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: Upheld

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Humira (CF) 40 mg/0.4 mL syringe. Findings:  The physician reviewer found that records provided for review document that this patient is undergoing IVF. Her provider has recommended treatment with Humira to improve the patients chances of conception due to systemic NK cell activation. However, there is a lack of support for treatment with Humira in the treatment of patients with infertility. Moreover, the U.S. Food and Drug Administration (FDA) has not approved Humira for the treatment of systemic NK cell activation for patients in the treatment patients in this clinical setting. Seshadri and Sunkara reported on a systematic review and meta-analysis to assess NK cells in female infertility. The authors concluded that, On the basis of current evidence, NK cell analysis and immune therapy should be offered only in the context of clinical research. All told, the requested Humira (CF) 40 mg/0.4 mL syringe is not medically necessary for treatment of this patient. 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 obstetrics and gynecology 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

A forty-nine year-old female who underwent cochlear implantation is requesting authorization to replace the older speech processor with the Freedom model.  It is documented that the patient continues to receive benefit from the original processor.Reviewers Findings:  The reviewing physician found that the patient currently has a functioning speech processor; the availability of a newer, more advanced model does not indicate a need for replacement of the existing model.  The reviewing physician found that the Health Plan denial should be upheld.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Votrient 200 mg tablets, Mekinist 0.5 mg tablets, and Ibrance 75 mg capsules. There is a lack of support for Votrient, Mekinist and Ibrance in the treatment of this patients metastatic cancer of probable ovarian origin. However, these agents have not received U.S. Food and Drug Administration (FDA) approval for this patients diagnosis. Clinical trials have not found the medical regimen consisting of Votrient, Mekinist, and Ibrance to be safe and effective for this patients diagnosis. Findings:  The physician reviewer found that the National Comprehensive Cancer Network (NCCN) states that Votrient is an option for soft tissue sarcomas, Mekinist in certain melanomas, and Ibrance is useful in breast cancer. Moreover, there is a lack of data supporting selection of a medication regimen based on the results of genetic testing.One randomized study reported no substantial benefits with choosing a therapeutic regimen based on genomic assay versus a providers clinical judgment. Therefore, the requested Votrient 200 mg tablets, Mekinist 0.5 mg tablets, and Ibrance 75 mg capsules are not medically necessary for treatment of this patient. Final Result: The reviewer determined that the requested medication regimen 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 internal medicine with subspecialty certification in medical oncology 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 enrollee requested coverage for romiplostim subcutaneous injections. The enrollee has congenitally large platelets and was tested for the MYH9 gene mutation (May Hegglin line of disorders). There are not a large number of articles that exist to establish an absolute platelet standard in sports for immune thrombocytopenia (ITP) patients; therefore, clinical judgement is required for treatment of inherited thrombocytopenia derived from the MYH9 mutation in patients with platelets less than 100,000. According to literature available, due to severe risk for internal bleeding with ITP patients in high contact sports, they should not play with platelet counts less than 100,000/uL. This patient had borderline platelet counts of 103,000/uL and they likely will drop below this at varying times. Due to his occupation and above guidelines, the current standard hematologic treatment, including treatment with Romiplostim, would be based on the fluctuation of platelet count and not solely on two platelet counts over 100,000/uL. Romiplostim should be given here due to the patients high risk for bleeding in his profession. Final Result: The reviewer determined that the requested medication is medically necessary for the treatment of the enrollees medical condition.Credentials/Qualifications: The physician reviewer is board certified in hematology 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: Upheld

The patient is a 42-year-old female with hypertension who experienced nausea and edema on Norvasc therapy. The patient was then given a trial of Cozaar, which was successful. Based upon this response, the patient has requested authorization and coverage for Cozaar. The Health Plan has denied the patients request on the basis that Cozaar is not medically necessary for treatment of the patients hypertension. There are multiple medications available for the treatment of hypertension. Common classes include calcium channel blockers, ACE inhibitors, and beta-blockers for initial therapy. Review of the submitted records indicates the patient failed a calcium channel blocker due to symptoms. It is medically reasonable to try the patient on a different class such as an ACE inhibitor or a beta-blocker. It is usual and customary practice to generally reserve angiotensin receptor blockers for those patients who are intolerant to ACE inhibitors. There are several alternative medically appropriate choices available to the patient.Based upon the information set forth above, I have determined that the requested medication is not medically necessary for the treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.
Appeal type: Experimental/Investigational
Decision: Overturned

The parent of a six-year-old male enrollee has requested APC genetic testing for evaluation of the enrollees desmoid tumor of the thigh and risk for familial adenomatous polyposis (FAP).  Findings:  Three physician reviewers found that FAP can present classically as many hundreds of polyps in the colon or upper gastrointestinal tract or can present in an attenuated form where patients present with far fewer polyps (Vasen, et al). Most importantly, patients may also present with extracolonic manifestations such as desmoid tumors, sebaceous gland cysts, lipomas, osteomas, and fibromas, as well as ophthalmologic disorders. This patients provider has presented rationale for genetic testing that is firmly supported by the available medical evidence. The presence of germline mutations is associated with a high probability of colon cancer and other cancers as well. APC testing as ordered for this patient is within the standard of care and therefore likely to be more beneficial than any available standard alternative.
Appeal type: Medical Necessity
Decision: Overturned

The parent of an enrollee has requested authorization and coverage for ursodiol powder and compounded vancomycin HCL 900 mcg/mg (not less than, USP) powder.Very early onset inflammatory bowel disease (VEO-IBD) and primary sclerosing cholangitis (PSC) are both highly morbid conditions, with 30% of pediatric PSC patients requiring liver transplant within 10 years of diagnosis. There are currently no medications with an FDA indication for management of pediatric PSC, and other than the medications already trialed by the patient, there are no medications for VEO-IBD which do not cause systemic immunosuppression. The data on the use of vancomycin and/or ursodiol in these conditions are relatively sparse, but encouraging.In regard to ursodiol for PSC, a recent retrospective review of 263 pediatric PSC patients (Deneau, M., et al.) found that the ursodiol use was associated with normalization of lab studies (GGT) in 46% of patients within the first year of diagnosis. Furthermore, those who achieved GGT normalization had a 99% 5-year survival with native liver, compared to 77% in those whose GGT did not normalize. A smaller review of pediatric patients from two Italian centers (Ferrari, F., et al.) included 45 children with PSC. Patients were all treated with ursodiol, and some also received steroids and azathioprine for concurrent IBD. After a mean follow-up of 8.7 years, there was 93% survival with native liver. A randomized trial of ursodiol for pediatric PSC has completed recruitment but data are not yet available.Vancomycin has been found to be beneficial for both VEO-IBD and pediatric PSC. A small study of vancomycin in PSC (Davies, Y., et al.) showed improvement of GGT, liver enzymes and inflammatory markers in 14 children with PSC. Although a randomized controlled trial of vancomycin for pediatric PSC is still recruiting patients and does not yet have published results, this treatment is already in widespread clinical use. Vancomycin has been reported to be effective in the treatment of VEO-IBD, in combination with other antibiotics (gentamicin, amoxicillin, doxycycline, metronidazole, ciprofloxacin), presumably due to modulation of GI flora. One report showed vancomycin (with or without gentamicin) to induce sustained remission in 3 of 5 patients with severe refractory VEO-IBD (Lev-Tzion, R., et al.).The physician reviewer found that  the ongoing use of compounded vancomycin and ursodiol powder for this pediatric male patient with Crohns disease and primary sclerosing cholangitis is warranted. The medical literature supports the use of these medications to treat pediatric patients with VEO-IBD and PSC, and the patient has already demonstrated excellent response to these treatments. Under these circumstances, ursodiol powder and compounded vancomycin HCL 900 mcg/mg (not less than, USP) powder are medically necessary to treat the patients medical conditions.
Appeal type: Medical Necessity
Decision: Upheld

A 15-year-old male enrollee requested  Otrexup (methotrexate) 25mg/0.4ml injectable for medical treatment of the enrollees medical condition.  Findings:  The physician reviewer found that  the submitted documentation fails to demonstrate the medical necessity of the requested medication.  Methotrexate is important in the treatment of juvenile scleroderma.  In a retrospective study by Koch and colleagues, the authors noted that methotrexate was efficacious in the treatment of linear morphea in young patients, with or without corticosteroids.  In this patients case, the medical records do not document any treatment failure on conventional injectable methotrexate.  Documentation indicated that the patient is afraid of needles and would prefer to use the Otrexup auto-injector.  However, there appears to be no reason why the patient cannot have conventional parenteral methotrexate administered by a nurse or family member.  All told, Otrexup (methotrexate) 25mg/0.4ml injectable is not medically indicated for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested Repatha SureClick 140 mg/mL for treatment of the enrollees pure hypercholesterolemia, essential hypertension, and disorder of thyroid.  Findings: The physician reviewer found that the U.S. Food and Drug Administration (FDA) has approved Repatha for treatment of hypercholesterolemia in patients with heterozygous familial hypercholesterolemia (HeFH) who have not reached goal despite maximally tolerated statin dose, or patients with atherosclerotic vascular disease who have not reached goal despite maximally tolerated statin. This patient does not have LDL levels that are elevated enough to diagnose HeFH without evidence of tendon xanthomas or corneal arcus (Sniderman, et al). In addition, the FDA label points out those long-term studies have not been reported regarding cardiovascular morbidity and mortality. So long-term benefit of the medication has not yet been shown. For these reasons, the requested Repatha SureClick 140 mg/mL is not medically necessary for this patient.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 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: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary:  An enrollee has requested breast tomosynthesis for evaluation of her breast cancer screening.  Findings:  Two physician reviewers found that in this patient, the breast tomosynthesis portion of the exam was more beneficial as compared to standard 2D mammogram in screening for breast cancer. Medical studies have shown that the addition of three dimensional (3D) digital breast tomosynthesis (DBT) reduces false positives and increases cancer detection when compared to two dimensional full field digital mammography (FFDM, 2D) alone. Recall rates are reduced by 15-17%: 3D allows for separation of structures to differentiate architectural distortion from masses and overlapping fibroglandular tissue (asymmetries). Studies have also shown that there has been an increase in cancer detection by 33-53%: cancer detection increased from 6 cancers/1000 women screened with 2D to 8 cancers/1000 women screened with 3D. Three dimensional DBT allows better characterization of possible masses, spiculation, and architectural distortion. There is sufficient evidence supporting the use of tomosynthesis for routine breast cancer screening. Thus, breast tomosynthesis was likely to be more beneficial than any available standard modalities.  Final Result: Two reviewers determined that the services at issue were 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:  All three reviewers are board certified in diagnostic radiology 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

An enrollee has requested reimbursement and prospective authorization and coverage for Euflexxa injections provided. Findings:  The physician reviewer found that evidence based peer-reviewed literature supports the use of repeat series of viscosupplementation injections for the treatment of pain in patients with osteoarthritis of the knee. Hyaluronic acid has been found to be better than injected placebo or injected corticosteroids. In addition, the American Medical Society for Sports Medicine (AMSSM) recommends hyaluronan acid for appropriate knee osteoarthritis patients, based on a very large network meta-analysis. Viscosupplementation has been found to be safe and effective and allow for delay of total knee replacement, and more effective than corticosteroid injections. In this case, the patient has been diagnosed with osteoarthritis of both knees. She had been treated with corticosteroid injection, extensive physical therapy, medications, and activity modification without sustained relief. She has undergone prior series of viscosupplementation with reported significant sustained relief of her chronic osteoarthritis pain. Therefore, the Euflexxa injections provided and requested were and are medically necessary for treatment of the enrollees condition. Final Result: The reviewer determined that the services at issue were and are 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 orthopedic 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: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested digital breast tomosynthesis for evaluation of the enrollees risk for breast cancer.  Findings: Three physician reviewers found that 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, by separating the various layers of breast tissue, one can better detect abnormalities. This particular patient has breasts that have been described as being heterogeneously dense. While one could make the argument that her mammogram has not changed since the last study, it is specifically this subset of patients with dense breast tissue that can benefit most from tomosynthesis. The ability to separate out the overlapping structures enables the possibility of demonstrating an otherwise occult tumor. Thus, in this clinical setting, the use of the digital breast tomosynthesis was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.Final Result: Three reviewers determined that the diagnostic procedure 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: All three physician reviewers are board certified in diagnostic radiology 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.