Persius/imr-appeals huggingface dataset:
Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for proton beam radiation therapy. Currently, there is inadequate clinical data demonstrating that proton beam radiation offers a clinical benefit compared to conventional radiation therapy techniques in the treatment of prostate cancer. Sheets and colleagues reported on the comparative effectiveness of intensity modulated radiation therapy (IMRT), proton beam therapy, and conformal radiation therapy for prostate cancer. The authors found that in the comparison between IMRT and proton therapy, IMRT patients had a lower rate of gastrointestinal morbidity. The authors noted that no other significant differences were observed. The American Society of Radiation Oncology (ASTRO) noted that, The comparative efficacy evidence of proton beam therapy with other prostate cancer treatments is still being developed, and thus the role of proton beam therapy for localized prostate cancer within the current availability of treatment options remains unclear. In this case, the provider noted that due to the patients previous surgical history and complex anatomy, proton beam therapy is recommended over standard alternatives. However, there is a lack of data that patients with a prior history of surgery have improved outcomes when treated with proton therapy. Enrollment of the patient in a national study is insufficient justification for the use of proton therapy. All told, the requested proton beam radiation therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Findings:  Three of the three physician reviewers found the requested proton beam radiation therapy 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 services are 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 reviewers 1, 2, and 3 are board certified in radiation 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: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary:  An enrollee has requested breast tomosynthesis for evaluation of the enrollee, who was asymptomatic.  Findings: Two physician reviewers found that there is sufficient support for the service at issue in this clinical setting.  Breast tomosynthesis provides advantage to radiologists interpreting mammograms. This tomographic method often allows the reader to separate dense glandular elements from underlying mass/architectural distortion, resulting in a decrease in biopsies and callbacks and increase in detection of small cancers compared to two-dimensional imaging alone. Thus, the addition of tomosynthesis to the usual two-dimensional protocol was likely of greater benefit to the patient than had her examination been done with two-dimensional imaging alone.Final Result: Two 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: 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.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested Sovaldi for treatment of the enrollees chronic hepatitis C virus genotype 3.  Findings: The physician reviewer found that according to 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, regardless of fibrosis, should be treated except those with limited life expectancy due to non-liver-related conditions. Patients with cirrhosis are high priority for therapy. The AASLD/IDSA guidelines cite data showing decreased survival with delay in therapy (Jezequel, et al). The ALLY-3 study demonstrated 71% cure rates in Sovaldi-experienced patients after 12 weeks of Sovaldi/Daklinza therapy (Nelson, et al). The AASLD/IDSA guidelines use this evidence to make a Class IIa, Level C recommendation to treat Sovaldi-experienced patients with 24 weeks of Sovaldi, Daklinza, and ribavirin. The use of PEG-interferon and ribavirin with Sovaldi is not recommended. Therefore, the requested therapy with Sovaldi for 24 weeks (to be used with Daklinza and ribavirin) is supported as medically necessary for the treatment of this patients hepatitis C infection.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 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: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested digital breast tomosynthesis for evaluation of the enrollees breast cancer screening.  Findings: Two physician reviewers found that tomosynthesis is a technique that was developed as a problem solving adjunct to routine mammography. In this case, the patient has dense breasts. 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. Given the support cited above, the breast tomosynthesis was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.Final Result: Two of 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.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested Harvoni for treatment of the enrollees chronic hepatitis C virus genotype 1b.  Findings: The physician reviewer found that according to the most recent 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 limited life expectancy due to non-liver-related conditions. The guidelines recommend that all patients should be treated, regardless of fibrosis stage. The guidelines recommend that treatment-naive genotype 1b patients should be treated with Harvoni. These recommendations are based on multiple randomized clinical trials, and the medication is U.S. Food and Drug Administration (FDA) approved for all patients with chronic hepatitis C genotype 1 regardless of fibrosis stage (Kowdley, et al; Afdhal, et al). The AASLD and IDSA guidelines cite data showing reduced survival with delayed treatment (Jezequel, et al). For these reasons, the requested treatment with Harvoni is supported as medically necessary for the treatment of this patients hepatitis C infection.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 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: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the digital breast tomosynthesis for evaluation of the enrollees risk for breast cancer. Findings:  Two 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. In this particular patient, the presence of breast implants is not an indication for tomosynthesis. However, she has breasts that have been described as heterogeneously dense. While one could make the argument that her mammogram has not changed since the last study, it is specifically this type of patient with 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. Final Result: The 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: Reviewers 1, 2 and 3 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.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary:   An enrollee has requested Sovaldi and ribavirin for 12 weeks for treatment of his hepatitis C virus.  Findings:  Three physician reviewers found that as recommended by the joint guidelines from the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) all patients with chronic active hepatitis C are eligible for treatment and should be treated with U.S. Food and Drug Administration (FDA) approved antiviral therapy regardless of fibrosis score. Successful hepatitis C treatment results in sustained virologic response (SVR), which is tantamount to virologic cure, and as such, is expected to benefit nearly all chronically infected persons. Per the AASLD/IDSA guidelines, daily sofosbuvir (Sovaldi) and weight-based ribavirin for 12 weeks is recommended for treatment-naive patients with hepatitis C genotype 2. As such, the requested treatment is medically necessary and is considered the standard of care for the treatment of the patients with hepatitis C genotype 2.  Final Result: All three reviewers determined that the requested medications are medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: Two reviewers are board certified in internal medicine with sub-specialty certification in gastroenterology and are actively practicing. One reviewer is board certified in gastroenterology and is 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

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Orthovisc injection series in both knees.An exhaustive review of the current medical literature pertaining to viscosupplementation reveals mixed results. Evidence from eight systematic reviews and six randomized controlled trials indicates that although viscosupplementation may relieve knee pain in some individuals with osteoarthritis, it is not known as to which individuals will benefit. Different studies have tried mixing hyaluronic acid with corticosteroids, platelet rich plasma, and other agents to make it more effective. The current evidence is limited, and guidelines from organizations such as the American Academy of Orthopedic Surgeons indicate that the evidence is not conclusive. In light of the foregoing, viscosupplementation can only be recommended in individuals with a history of lasting benefit from prior injections, and in carefully selected cases where everything else has been tried, and the options are limited. In this case, there is a history of significant relief from prior viscosupplementation. Furthermore, the patients options are limited. The patient has tried and failed other conservative treatments, with the alternative being bilateral total knee arthroplasties. Therefore, Orthovisc injections series in both knees are medically necessary for the 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 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: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: A male enrollee has requested authorization and coverage for Epclusa for 12 weeks for treatment of the enrollees hepatitis C virus.Findings:  The physician reviewer found that according to the 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, and advanced fibrosis is not required for treatment. Per the guidelines, Epclusa is recommended as first-line therapy for treatment naive genotype 2 patients, based on clinical trials including ASTRAL-1 and ASTRAL-2, which showed a 99% cure rate and superiority to Sovaldi (sofosbuvir) with ribavirin (Feld, et al; Foster, et al). Delay in treatment may result in decreased survival. For these reasons, Epclusa for 12 weeks is medically necessary for the treatment of the patients hepatitis C infection. 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 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

A 48-year-old male enrollee has requested for endovenous laser ablation of the accessory greater saphenous vein of the left leg for treatment of his varicose veins.  Findings:  Three physician reviewers found that EVLT is often useful for large branches, particularly when they are long, straight segments that are essentially part of a paired saphenous system. Neovascularization is a recognized phenomenon, particularly following saphenofemoral junction dissection. However, there is limited data pertaining to the use of EVLT for accessory veins (i.e., not one of the major saphenous branches). The alternative standard treatment for accessory veins is to remove the branch via stripping or phlebectomy, or to use some form of sclerotherapy, although this tends to have a high rate of recurrence. With the appropriate anatomy, an endovenous approach does tend to be associated with less morbidity. Thus, the use of EVLT for accessory veins which are essentially acting as the greater or small saphenous vein is medically reasonable and appropriate.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary:  An enrollee has requested Euflexxa injections 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.  The medical literature does not support viscosupplementation in this clinical setting.  Jevsevar and colleagues performed a systematic review to determine the clinical significance of injectable hyaluronic acid.  Meta-analysis of only the double-blinded, shamcontrolled trials did not show clinically important differences of hyaluronic acid treatment over placebo.   All told, the requested Euflexxa injections are 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 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: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for albendazole (400 mg) and ivermectin (200 mg) each daily for 28 days, then off for two weeks, then repeat this for two more cycles for a total of three cycles. In this case, the records do not document parasitic infection. Given that there are no pathologic specimens documenting a parasitic infection, the requested medication is not medically indicated. Therefore, albendazole (400 mg) and ivermectin (200 mg) each daily for 28 days, then off for two weeks, then repeat this for two more cycles for a total of three cycles are not medically necessary for the treatment of this patient. Final Result: The reviewer determined that the requested medications 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 internal medicine with sub-specialty certification in infectious 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 reimbursement for the FoundationOne gene testing. Findings:  The physician reviewer found that FoundationOne testing offers a comprehensive panel of molecular genetic markers on an individuals tumor with the hopes of identifying markers than can help guide therapy decision making. The National Comprehensive Cancer Network (NCCN) guidelines indicate that the efficacy of standard of care treatment for recurrent glioblastoma is suboptimal, and for eligible patients consideration of clinical trials is highly encouraged. Prior treatment may impact enrollment in the majority of clinical trial options. Molecular characterization of primary brain tumors/gliomas has had a substantial impact on stratification and eligibility in clinical trials for central nervous system neoplasms over the last 10 years, and is increasingly becoming a common part of standard neuro-oncology management. Molecular profiling can identify potential molecular markers for which ongoing clinical trials may be available. Thus, the use of molecular profiling with FoundationOne testing was likely to be more beneficial for evaluation than available standard therapy to guide decision making.  Final Result: Two of the three reviewers determined that the testing 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 reviewers 1, 2 & 3 are  board certified in internal medicine with sub-specialty certification in medical oncology and are actively practicing. The reviewers are an 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: Upheld

Nature of Statutory Criteria/Case Summary:  An enrollee has requested Sovaldi for 24 weeks for treatment of his hepatitis C.  Findings:  The physician reviewer found that according to joint guidelines issued by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, all patients with chronic hepatitis C should be treated except those with limited life expectancy due to non-liver-related conditions. The guidelines recommend an interferon-free Sovaldi regimen and an interferon-containing Sovaldi regimen for non-cirrhotic treatment-naive patients with hepatitis C, genotype 3 (Sovaldi and Daklinza for 12 weeks or Sovaldi/peg-interferon/ribavirin for 12 weeks).  For patients who are ineligible for Daklinza or interferon, the guidelines recommend Sovaldi and ribavirin for 24 weeks as an alternate regimen.  The guidelines recommend Sovaldi and ribavirin last because it proved to be less effective than Sovaldi/peg-interferon/ribavirin in the BOSON trial.  Although hepatitis C treatment is needed in this case, no reason is provided to use Sovaldi and ribavirin rather than the regimens recommended by the current guidelines.  For these reasons, the requested treatment with Sovaldi for 24 weeks is not medically necessary for the treatment of this patients hepatitis C infection. 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 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.