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

Nature of Statutory Criteria/Case Summary: An enrollees parent has requested authorization and coverage for a leadless pacemaker (single chamber implantable transcatheter pacing system). Patients who require a pacemaker at a young age have an increased risk of complications with their pacemaker leads since they will likely require pacing for their entire lives. Data has demonstrated that pacemaker lead complications increase with longer implant times. Moreover, young patients oftentimes damage or dislodge pacemaker leads with physical activity, which supports an indication for a leadless pacemaker. As this young patient requires a pacemaker for her diagnosis of Mobitz type 2 AV block and AV block Mobitz type 1, Wenckebach, the requested implantable leadless pacemaker is supported over standard pacemakers with leads. Given these findings, the requested a leadless pacemaker (single chamber implantable transcatheter pacing system) is 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 a leadless pacemaker (single chamber implantable transcatheter pacing system) is 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 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 internal medicine with subspecialty certification in cardiovascular disease and is actively practicing. Physician reviewer 2 is board certified in internal medicine with subspecialty certification in cardiovascular disease and is actively practicing. Physician reviewer 3 is board certified in internal medicine with subspecialty certifications in cardiovascular disease and cardiac electrophysiology 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: Experimental/Investigational
Decision: Upheld

A 35-year-old male enrollee has requested for Sutent therapy for treatment of the enrollees neuroendocrine tumor (NET).  Findings:  Two physician reviewers found that Sutent is one of a new class of drugs that inhibits a variety of tumor-related factors such as vascular epithelial growth factor. It has been approved for use in renal cell carcinoma and is being actively studied in other cancer types. Submitted with the appeal are two abstracts from ASCO. One study demonstrated some impact of the drug on biologic markers expressed in such patients, but was not intended to assess clinical benefit. The other study focused on safety and pharmacokinetic issues in the use of Sutent in patients with a variety of cancer types. One response was noted in a patient with neuroendocrine tumor, although, again, there was no information as to the real clinical benefit of the drug. Additionally, a variety of serious toxicities were seen. As yet, there is very little information as to the possible clinical advantage of this drug in the treatment of pancreatic neuroendocrine carcinoma.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: A 56-year-old male enrollee has requested reimbursement for long-term acute care inpatient stay for treatment of  Guillain-Barre syndrome and West Nile virus. Findings:  The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue.   Guillain-Barre syndrome generally has a favorable natural course and relatively good prognosis.  There are treatment options such as intravenous immunoglobulin and plasma exchange that have demonstrated to be effective treatments for this condition. However, despite the generally good prognosis and available therapeutic options, some patients continue to have significant functional impairments at six months or longer following the onset of symptoms.  To date, highly intensive rehabilitation services have not been proven to effectuate better long-term functional outcomes.  In this case, the patient has had multiple premorbid conditions and was reported to be disabled at baseline.  He underwent prolonged inpatient treatment and recovered his respiratory and swallowing function.  He has been undergoing rehabilitation, but has remained essentially dependent for care.  However, the records do not demonstrate that the patient has required long-term acute care (LTAC) level care.  LTAC level care is considered medically necessary when care is needed that is more medically complex than can be handled at lower levels of care such as inpatient rehabilitation, skilled nursing facility or outpatient care.  Examples of treatments that are considered consistent with this level of care include the following: chest tubes, extensive wound care, stable cardiac drips, multiple intravenous antibiotics, hemodialysis/peritoneal dialysis, prolonged intravenous therapy, total parenteral nutrition, tracheostomy care/extensive pulmonary services, ventilator weaning, and frequent imaging/laboratory testing.  Usually more than one of these treatments is being provided at the LTAC level of care.  There should also be documentation of prior treatment failure at lower levels of care and/or reasonable expectation of treatment failure at lower levels of care.  There is no documentation supporting that a LTAC level of care is necessary for this patient.  He has been weaned from mechanical ventilation and decanulated.  He is not on any intravenous therapy, total parenteral nutrition or other complex treatment that could not be provided at a lower level of care. Final Result: The reviewers 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: Upheld

Physician 1:  The patient is a 72-year-old male with a synovial cyst and foraminal stenosis. He has low back pain radiating to the lower extremities. He and his provider have requested authorization and coverage for X STOP decompression surgery. The Health Plan has denied this request on the basis that the requested procedure is considered experimental/investigational.Although X STOP decompression is a novel, minimally invasive approach to decompression surgery, it has not yet been proven to be as or more efficacious than traditional decompression surgery. Long-term safety studies and re-operation rates have not been confirmed. At this time, traditional decompression surgery is still the standard of care surgical option for the treatment of spinal stenosis. Therefore, I have determined that the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 2:  The patient is a 72-year-old male with degenerative spinal stenosis at L4-L5 and L5-S1. He has attempted multiple conservative therapies without sustained relief. The patient is requesting authorization for a two-level X STOP implantation procedure. The Health Plan indicates there is insufficient evidence demonstrating the efficacy of X STOP implantation at this time.The X STOP procedure is still experimental as long-term follow-up data is not yet available. Also, the short-term data does not demonstrate that the success rates are better than conventional lumbar laminectomy, which is the gold standard procedure in this setting and is safe and effective. Since no data exists to suggest that X STOP is superior to conventional laminectomy decompression surgery, I have determined that the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 3:  The patient is a 72-year-old male with lower back pain with radiation to his buttocks and thighs bilaterally. Conservative treatment and a laminectomy in 2002 at L5-S1 have not relieved his symptoms. MRIs performed in December 2005 and February 2006 showed degenerative changes and a large facet synovial cyst at L4-5 on the right with neural foraminal stenosis at L5-S1 on the right. Bi-level X STOP implantation surgery has been recommended. The Health Plan considers this procedure investigational and therefore has denied coverage. A pre-market approval application for the X STOP device was filed in January 2004 and the outcome results are being collected as required. At this time the procedure is of unproven efficacy. Long-term results are unknown and the procedures risks, long-term viability, and complications are unclear. As such, the procedure cannot be recommended at this time. Accordingly, I have determined the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.
Appeal type: Medical Necessity
Decision: Overturned

The parent of a 14-year-old female has requested applied behavioral analysis (ABA) therapy at a frequency of 6 hours per week for treatment of her autism.  Findings:  The physician reviewer found that review of the submitted documentation demonstrates that this patient has significant behavioral and mental dysfunction. Her most serious dysfunction seems to be her obsessive activity, which freezes her into inactivity. ABA techniques have a well-documented history of effectively altering maladaptive behaviors. The medical literature strongly supports the treatment of autism with ABA therapy. The effectiveness of ABA based intervention in autism has been well documented through five decades of research. (Myers, et al.) The efficacy of ABA therapy has been proven in multiple controlled studies (Sallows and Graupner; and Remington, et al.). This patient has been diagnosed with autism and ABA therapy is the documented therapy of choice. There is limited data available regarding what age ABA techniques should be terminated. Therefore, ABA therapy should be continued through the date in question, at which time the patient should be reassessed to determine whether her obsessive behaviors have improved. If no improvement is noted, psychiatric assessment would be appropriate at that time.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Vascepa. The submitted documentation supports the medical necessity of the requested medication. Rosenson and Eckel note that Vascepa is more than 95 percent icosapent ethyl and that in a small trial of patients with very high fasting triglyceride levels, reduced triglyceride levels up to 45 percent, but did not significantly affect low-density lipoprotein cholesterol (LDL-C) levels. In this clinical setting, given that the patient has hypertriglyceridemia and is unable to take fibrates, the requested medication is medically indicated. Therefore, Vascepa is medically necessary for the 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 internal medicine with sub-specialty certifications in cardiovascular disease and in clinical cardiac electrophysiology 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 49-year-old female enrollee has requested for artificial disc replacement for treatment of her degenerative disc disease.   Findings:  Two physician reviewers found that Tthere is no evidence that disc replacement reliably, reproducibly, and over long periods of time fulfills the three primary aims of clinical efficacy, continued motion, and few adjacent segment degenerative problems. The potential problems that may occur with longer follow-up have not been fully documented. Zigler et al, recently completed a randomized, prospective, multicenter study of the ProDisc-L versus circumferential fusion for low back pain. This study identified a reasonable cohort, subscribed the sample in a short time period, and demonstrated minimal attrition. Total disc replacements should still be considered an investigational procedure without long-term follow-up and should only be used within the context of strict clinical trials.
Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested digital breast tomosynthesis for evaluation of the enrollee, who had a left breast lump.  Findings: Three 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, there were two valid indications for tomosynthesis.  First, her breast tissue was heterogeneously dense.  The ability to separate out the overlapping structures enables the possibility of demonstrating an otherwise occult tumor.  Second, the presence of a palpable mass, especially with dense breast tissue, must be fully evaluated.  There is sufficient support for the service at issue in this patients case. Thus, digital breast tomosynthesis was likely to have been more effective than other methods of evaluating this patient.  Final Result: Three 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: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for the LINX Reflux Management System (LINX). Findings:  Two of the three physician reviewers found there is a lack of randomized controlled trials with long-term follow-up demonstrating that LINX is safer or more effective than Nissen fundoplication or other surgical anti-reflux procedures. Adverse events, such as erosion through the esophagus, have been reported in the period after U.S. Food and Drug Administration approval. Additionally, LINX (more than surgical fundoplication) is associated with severe dysphagia requiring endoscopic intervention. The currently available peer-reviewed literature does not definitively support the conclusion that LINX is more likely to be beneficial in this case than standard treatment, surgical fundoplication. American College of Gastroenterology guidelines for the management of reflux disease also state that more evidence is needed before LINX can be recommended. For these reasons, the LINX Reflux Management System is not likely to be of greater benefit than other available treatment options.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 internal medicine with sub-specialty certification in gastroenterology and are actively practicing. The reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition
Appeal type: Medical Necessity
Decision: Overturned

A 35-year-old male enrollee has requested Testim 1% gel for treatment of his hypogonadism. Findings:  The physician reviewer found that the medical records reflect an improvement of the bioavailable Testosterone after treatment with Testim. Total Testosterone is not sufficient to assess the androgen status of any male patient. Many co-morbid conditions will alter both Albumin and Sex Hormone-Binding Globulin levels resulting in different bioavailable Testosterone with the same Testosterone level. These conditions have been well studied and reported as seen in the references by Vermeulen cited above.
Appeal type: Medical Necessity
Decision: Overturned

The patient is a three-year-old female with a history of recurrent otitis media. She is also status post ear tube placement with continued drainage and ear infections after the tubes fell out. The ear, nose and throat physician documented continued fluid behind the eardrum. Audiology has documented a decrease in hearing from the right ear. The patient has speech delays documented by a speech therapist.At issue is whether continued speech therapy is medically necessary for treatment of the patients condition.The Health Plans denial should overturned. Given the patients documented oral and hearing loss, speech therapy is medically necessary and indicated. In light of the documented delays, speech therapy is also restorative. Furthermore, based on the patients response to therapy to date, she is likely to benefit from continued therapy. As such, I have determined the patients condition is medical in nature and therefore, the requested therapy is medically necessary for treatment of the patients medical condition. The Health Plans denial should be overturned.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The parent of an enrollee has requested authorization and coverage for 38 hours per week of direct applied behavior analysis (ABA) services for at least six months is medically necessary for treatment of the patients medical condition. Based on the documentation submitted for review, the patient has made steady progress in many areas. However, the patient continues to require a high level of support. Failure to master these skills puts the patient at an increased risk for injury, and makes it increasingly difficult for him to be successful in more generalized environments. The Behavior Analyst Certification Board states that typical comprehensive ABA programs range from 30 to 40 hours of treatment per week. Given the support provided by the medical records provided in conjunction with current-peer-reviewed literature, the requested services 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 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

Nature of Statutory Criteria/Case Summary: An enrollee has requested Daklinza to be used in conjunction with Sovaldi for treatment of his hepatitis C virus. Findings: The physician reviewer found that per 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 state that patients with cirrhosis are high priority for treatment. According to the guidelines, this patient is interferon-ineligible due to a pre-existing medical condition. The guidelines recommend that cirrhotic treatment-naive patients with genotype 3 hepatitis C should be treated with Daklinza and Sovaldi (with or without ribavirin) for 24 weeks. This is based partially on the results of the ALLY-3 study, which demonstrated poor cure rates (only 58%) after 12 weeks of therapy. For these reasons, the requested treatment with Daklinza and Sovaldi 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: Medical Necessity
Decision: Overturned

The parent of a two-year-old male enrollee has requested coverage for speech therapy for treatment of the enrollees autism.  Findings:  The physician reviewer found that Turner and colleagues reported that the earlier and more intensive speech therapy that an autistic child receives, the better the prognosis for normalized speech in the autistic child. Paul and Sutherland emphasize that early intervention and intensity of speech therapy is essential for young autistic patients to develop meaningful speech. With regard to this particular patient, speech therapy is even more appropriate as he demonstrates normal or near normal intellect despite his speech delay and autistic features, and as such, is likely to derive significant benefit from early intervention.