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

Nature of Statutory Criteria/Case Summary: The parent of an enrollee has requested authorization and coverage for modafinil. Findings:  The physician reviewer found that there is a lack of support in the medical literature for the requested medication in this clinical setting. Modafinil is a medication that promotes sleep, and when used in patients who are sleep-deprived, can improve mood, fatigue, sleepiness, and cognition. However, at this time, modafinil is not approved for use in children under the age of 17. It has been approved by the U.S. Food and Drug Administration for use in narcolepsy, shift-work sleep disorder, and obstructive sleep apnea with residual excessive sleepiness not resolved by use of continuous positive airway pressure. While there are clinical trials at major study centers looking at its use in children, currently, modafinil cannot be recommended for use in this patients case. Other treatment options should be investigated. For these reasons, modafinil 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 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

Nature of Statutory Criteria/Case Summary: An enrollee has requested surgical lobectomy of the right lung for treatment of the enrollees adenocarcinoma of the right lung. Findings:  The physician reviewer found that while there exists some controversy regarding surgery for stage IIIa lung cancer patients, in this case, the patient is a good candidate for surgical lobectomy of the right lung. As the above references suggest, studies reveal that patients diagnosed with stage IIIa lung cancer with non-small cell tumors may benefit from surgery. The studies also show that younger fit patients without severe medical issues who undergo pre-operative chemoradiation followed by lobectomy with mediastinal lymph node dissection have longer term survival rates. Based on available studies, this patient is a good candidate for the requested procedure. In sum, a surgical lobectomy of the right lung is medically necessary for this patient.Final Result: The reviewer determined that the requested procedure 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 thoracic 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: Upheld

A 44-year-old female enrollee requested authorization and coverage of proton beam therapy to the right eye for treatment of adenoid cystic carcinoma.  The health plan denied the enrollees request indicating that the requested treatment is not medically necessary.One physician reviewer performed a medical necessity Independent Medical Review.  The physician reviewer upheld the health plans denial on the basis that the requested treatment is not medically necessary.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage of Epclusa tablets 400/100 sofosbuvir/velpatasvir tablets 400/100 mg for 12 week duration or Harvoni 90/400 mg for 12 week duration for treatment of the enrollees hepatitis C virus.Findings:  The physician reviewer found that according to joint guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), all patients with chronic hepatitis C should be treated except those with life expectancy less than 12 months due to non-liver-related conditions. This applies regardless of fibrosis stage. The patient should be considered treatment-naive as she failed interferon/ribavirin rather than PEG-interferon/ribavirin. Per the guidelines, Epclusa is recommended as first-line for treatment-naive, genotype 2 patients, based on clinical trials including ASTRAL-1 and ASTRAL-2 trials for Epclusa, which showed superiority to Sovaldi with ribavirin (Feld, et al; Foster, et al). If the patient were considered treatment-experienced with PEG-interferon/ribavirin, the recommendation would be the same, based on ASTRAL-2 (Foster, et al).  Delay in treatment may result in decreased survival (Jezequel, et al). For these reasons, Epclusa is supported as medically necessary for the treatment of this patients hepatitis C infection. Per the guidelines, the request for Harvoni is not supported in this case, as the ledipasvir component does not have sufficient activity against genotype 2, and the sofosbuvir component alone is insufficient. Therefore, the request for Harvoni is not supported as medically necessary for the treatment of this patients hepatitis C infection. Specifically, Epclusa tablets 400/100 sofosbuvir/velpatasvir tablets 400/100 mg is medically necessary for 12 week duration but Harvoni 90/400 mg for 12 week duration is not medically necessary for the treatment of this patients hepatitis C infection Final Result: The reviewer determined that portion of the requested medications 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 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: Experimental/Investigational
Decision: Upheld

Findings:  The physician reviewer found that An enrollee has requested authorization and coverage for computed tomography (CT) scan of the heart. In this case, the patient has significantly increased coronary risk. The American College of Cardiology (ACC) and American Heart Association (AHA) clinical practice guidelines do not recommend routine performance of specialized tests in the context of assessing coronary risk including coronary calcium quantification, coronary CT scanning, advanced lipoprotein analysis, genetic testing, and homocysteine. While the results of some of these specialized tests may be abnormal and considered independent risk markers for coronary disease, there is a lack of data from controlled trials that demonstrate outcome benefits by treating routinely obtained abnormal results. Treatment changes or additions based on the results of screening with these specialized tests has not been shown to improve cardiac outcomes over those achievable with treatment based on standard risk factor profiling and basic lipid analysis. Therefore, CT scan of the heart is not likely to be more beneficial for evaluation of the patients condition than any available standard therapy.Findings:  Three of the three physician reviewers found the requested CT scan of the heart is 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 service 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.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested proton beam therapy for treatment of her medical condition.  Findings:  The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested services.  There is a lack of medical literature to suggest that treatment with proton beam radiation offers a clinical benefit compared to conventional radiation therapy techniques for breast cancer.  Standard treatment with photon radiation is associated with a very low risk of toxicity.  There is no data submitted that suggests that treatment with proton techniques will be able to improve sparing of the skin, heart, and/or lungs compared to standard breast radiation with photon techniques.  Consensus group guidelines do not support the use of proton therapy in this setting.  The current medical evidence does not support the requested services in this patients case.  All told, proton beam therapy is not medically indicated for the treatment of this patient.   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 radiation 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

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for nusinersen (Spinraza) for treatment of her spinal muscular atrophy type 2. Findings: The physician reviewer found that spinal muscular atrophy is a rare autosomal recessive disorder characterized by muscle atrophy and weakness resulting from motor neuron degeneration in the spinal cord and brainstem. It is most commonly caused by insufficient levels of survival motor neuron (SMN) protein, which is critical for motor neuron maintenance, secondary to deletions or mutations in the SMN gene. Spinraza is a modified antisense oligonucleotide that binds to a specific sequence in the intron, downstream of exon 7 on the pre-messenger ribonucleic acid (pre-mRNA) of the SMN2 gene. This modulates the splicing of the SMN2 mRNA transcript to include exon 7, thereby increasing the production of full-length SMN protein. This patient developed spinal muscular atrophy type II with exon 7-8 deletion and her condition is likely to respond to treatment with Spinraza given the current medical literature. Thus, the requested Spinraza is supported as medically necessary for treatment of this patients spinal muscular atrophy.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 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: Upheld

A 62-year-old female enrollee has requested continued intravitreal injections of bevacizumab (Avastin) for treatment of her central retinal vein occlusion and macular edema. Findings:  Two physician reviewers found that although there is some scientific evidence demonstrating that intravitreal injections of Avastin may show short-term benefit in some patients who have the diagnosis of non-ischemic central retinal vein occlusion, there is a lack of evidence demonstrating that this treatment is superior over the standard therapy for this condition.  The standard therapy in this clinical situation is laser photocoagulation and/or intravitreal triamcinolone, neither of which was tried on this patient before the use of Avastin. Although it appears this patient might have received some short-term benefit from her Avastin injections, there is a lack of support in the medical literature that demonstrates a long-term benefit of such injections. Furthermore, the use of Avastin in this setting is not supported until standard therapies have been exhausted.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Saxenda 3 mg/0.5 mL. Findings:  The physician reviewer found that diet, physical activity, and behavioral modifications are the cornerstones of weight management, weight loss achieved by lifestyle modifications alone is often limited and difficult to maintain. Pharmacotherapy for obesity can be considered if patients have a BMI of 30 kg/m2 or greater or BMI of 27 kg/m2 or greater with weight-related comorbidities. The Endocrine Society guidelines recommend that diet, exercise, and behavioral modifications are included in all obesity management approaches. Other tools, such as weight loss medications and bariatric surgery, can be combined with behavioral changes to reduce food intake and increase physical activity. Patients who have been unable to successfully lose weight and maintain a goal weight may be candidates for prescription medication. If a patient responds well to a weight loss medication and loses 5 percent or more of their body weight after three months, the medication should be continued. As body weight reduction is the main modifiable risk factor for polycystic ovary syndrome, therapeutic approaches in overweight or obese women with polycystic ovary syndrome have been developed. Saxenda (liraglutide) is a glucagon-like peptide-1 receptor agonist that promotes sustained weight loss, as well as abdominal fat reduction, in individuals with obesity, prediabetes, and type 2 diabetes mellitus. The majority of current clinical studies have demonstrated that liraglutide therapy achieved significant reductions in body weight, body mass index, and abdominal circumference in overweight and obese women with polycystic ovary syndrome. This patient has a history of obesity as determined by her BMI, which was 32.08 kg/m2 on 7/02/20. She has comorbidities including PCOS and hypertriglyceridemia. The patient has attempted to lose weight through lifestyle modification such as caloric restriction, exercise, and behavioral changes. The submitted documentation shows that the patient was treated with liraglutide (Saxenda) 3 mg with a good response and weight loss. Therefore, Saxenda 3 mg/0.5 mL 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 internal medicine with sub-specialty certification in endocrinology, diabetes and metabolism, 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 61-year-old female enrollee has requested a referral to an out-of-network plastic and reconstructive surgeon for the treatment of her medical condition following multiple breast surgeries. Findings:  The physician reviewer found that this patient has undergone medically necessary breast reduction surgery. As noted in the most recent plastic surgery consultation notes, she has had surgery and as a consequence will always have some scarring and asymmetry.  The consultants note that her outcome is considered to be acceptable and consistent with the standard of care. The photographs show an aesthetic outcome that is within the range of an acceptable result among the reconstructive surgery community following breast reduction surgery. Thus, the patients condition as the result of prior surgery does not constitute an abnormal structure of the body. Therefore, reconstructive surgery is not indicated according to Californias Reconstructive Surgery Statute as the factors are not met in this patients case. The next question is whether additional breast surgery to correct the patients aesthetic defects is medically necessary. Additional reconstructive surgery is not warranted or medically necessary for this patient. Her present outcome is consistent with an expected outcome following breast reduction surgery. There is no medical record documentation of any functional deficit resulting from her condition. All told, there is no evidence to support additional breast surgery from a medical standpoint.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary:  An enrollee has requested Sumatriptan Succinate, quantity 75, for treatment of her migraine headaches.   Findings:  The physician reviewer found that the submitted documentation fails to establish the medical necessity of the requested medication quantity. Per U.S. Food and Drug Administration (FDA) guidelines the maximum dosage of Sumatriptan in a 24-hour period is two doses, due to the potential for vasospasm which may cause stroke or myocardial infarction, and the development of serotonin syndrome for those patients who are on selective serotonin reuptake inhibitors (SSRI) drugs. The use of triptans more than three days a week is likely to cause medication overuse headache, whereby headache occurs in the absence of the offending acute therapy. This has been well documented with the use of triptans. The use of greater than two Sumatriptan injections a day on a daily basis is not the standard of care, and places the patient at risk for not only escalating headache, but cerebral and coronary vasospasm which could be life threatening. The approval of Sumatriptan Succinate quantity 75 is excessive, potentially places the patient at risk, and not medically necessary for treatment of 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 neurology 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 41-year-old female enrollee requested gene expression profiling or evaluation of her colon cancer.  Findings:  Two physician reviewers found that Oncotype Dx was developed and validated as a gene expression assay that predicts with some accuracy the risk of recurrence in stage II colon cancers. As such, it is frequently used in contexts where decisions regarding use of chemotherapy are challenging. In this case, the patient was pregnant and prognostic information about the expected course of her colon cancer was invaluable, and influenced management decisions. Although Oncotype Dx predicts risk of recurrence, it has not been shown to be predictive of the benefit of adjuvant chemotherapy, and as such adds little to decision making in this regard. However, in this case, where decisions were required to be made not only about chemotherapy, but also about ongoing management of a high-risk pregnancy, the prognostic information provided by the assay was of value. Therefore, in this clinical setting the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.
Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for occipital nerve block therapy. Chronic headaches are debilitating and can significantly decrease a patients quality of life. Findings:  The physician reviewer found that this patient with chronic headaches, alternating treatment with Botox and occipital nerve blocks have decreased her headaches by greater than 75%. On review of the records, occipital nerve block therapy was supported in the medical literature for use in this patients clinical setting. Ebied and colleagues found that, Occipital nerve block as adjunctive therapy has shown safety and efficacy in treating patients with migraines, measured by the reduction in pain. In addition, Juskys and Sustickas noted that, Occipital nerve block with a local anaesthetic and corticosteroids provides a safe, simple, and effective treatment method for the patient with medically-refractory occipital neuralgia. Given these findings, the occipital nerve block therapy was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Findings: Two of the three physician reviewers found the occipital nerve block therapy was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: Physician reviewer 1 is board certified in anesthesiology with subspecialty certification in pain medicine and is actively practicing. Physician reviewer 2 is board certified in anesthesiology with subspecialty certification in pain medicine and is actively practicing. Physician reviewer 3 is board certified in physical medicine and rehabilitation with subspecialty certification in pain medicine 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.