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

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for transcatheter closure of patent foramen ovale (PFO). A series of studies recently confirmed the safety and efficacy of catheter based PFO closure in reducing the incidence of cryptogenic stroke. In the medical literature, among patients with a PFO who had had a cryptogenic stroke, the risk of subsequent ischemic stroke was lower among patients assigned to PFO closure combined with antiplatelet therapy than among those assigned to antiplatelet therapy alone. Among patients who had a recent cryptogenic stroke attributed to PFO with an associated atrial septal aneurysm or large interatrial shunt, the rate of stroke recurrence was lower among those assigned to PFO closure combined with antiplatelet therapy than among those assigned to antiplatelet therapy alone. Among adults who had had a cryptogenic ischemic stroke, closure of a PFO was associated with a lower rate of recurrent ischemic strokes than medical therapy alone during extended follow-up. PFO closure is appropriate in patients with PFO and cryptogenic stroke and has been found to decrease the incidence of subsequent stroke. Thus, the requested transcatheter closure of PFO is supported as likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: All three reviewers determined that the requested transcatheter closure of patent foramen ovale is 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:  One reviewer is board certified in surgery with sub-specialty certification in cardiothoracic surgery and is actively practicing. One Reviewer is board certified in surgery with sub-specialty certification in cardiothoracic surgery and is actively practicing.  One Reviewer is board certified in internal medicine with sub-specialty certification in cardiovascular disease 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: Upheld

A 54-year-old female enrollee has requested a physical movement therapy device for treatment of her muscle atrophy and spasticity.  Findings:  The physician reviewer found that the requested device (Flexiciser) is an exercise device that utilizes upper body ergometry and provides passive leg movements.  There is a lack of published high-grade studies to substantiate that the device is effective in treating anoxic brain injury or tetraparesis, or is effective in treating or preventing adverse sequelae related to anoxic brain injury or tetraparesis.  There are very minimal high-grade data related to this specific type of therapy (active upper body ergometry with passive leg cycling) that is published in the literature.  In 2007, Ballaz and colleagues studied the acute vascular responses to this type of therapy in 15 volunteers with spinal cord injury.  The authors concluded that acute passive leg cycle exercise increases vascular blood flow velocity in paralyzed legs of people with paraplegia. This was followed up by a pilot study in 2008 that did not demonstrate sustained clinical effects following training.  The 17 subjects in the study had paraplegia and underwent 36 passive cycling sessions at home.  After training, however, mean blood flow velocity at rest did not differ from pre-training values.  The authors concluded that six weeks of home-based passive cycling training have no significant effect on the rest hemodynamic values.Astorino and colleagues published a small study related to the Flexiciser device in 2008.  This case series only involved eight subjects.  The authors concluded that this rehabilitative device has promise for individuals with acute spinal cord injury and those with chronic spinal cord injury who are attempting to initiate a rehabilitation program. However, the authors noted that the device may be ineffective for regular exercisers due to an inadequate exercise stimulus.  Overall, there are insufficient data in the prevailing peer-reviewed published medical literature to conclude that the requested device is effective for the treatment or prevention of complications related to anoxic brain injury or tetraparesis.  All told, the requested physical movement therapy device is not medically indicated for this patient.
Appeal type: Experimental/Investigational
Decision: Upheld

A 36-year-old male enrollee has requested platelet rich plasma (PRP) injection for treatment of his Achilles tendinitis.  Findings:  Three physician reviewers found that based on the available peer-reviewed medical literature, platelet rich plasma injections are not likely to be more beneficial for the treatment of this patients chronic Achilles tendonitis than any available standard therapy. Review of medical literature pertaining to this treatment and injectable treatments show varied results with conflicting methodologies and inconclusive evidence. Further randomized studies are necessary to assess the benefit of injectable therapies. All told, the platelet rich plasma injections are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.
Appeal type: Medical Necessity
Decision: Overturned

The patient is a 24-year-old woman with a body mass index (BMI) of 55 and comorbid conditions. The patient has requested authorization for the duodenal switch procedure. It does not appear the patient has obtained psychiatric clearance for weight loss surgery. The Health Plan has denied the patients request indicating that the duodenal switch procedure is not medically necessary. The Health Plan has authorized Roux-en-Y gastric bypass.The duodenal switch procedure has a track record greater than 15 years. The anticipated complications associated with other malabsorptive procedures (i.e., distal gastric bypass, jejunoileal bypass) has not been encountered with the duodenal switch. The duodenal switch has significant advantages in the super morbidly obese, especially when there is hepatosteatosis or a shortened mesentery making high Roux-en-Y gastrojej untenable. Furthermore, there is sufficient data to show that duodenal switch has a far more superior long-term outcome when compared to the gastric bypass. Therefore, the duodenal switch procedure is medically indicated for treatment of the patients super morbid obesity. However, although medically the patient meets criteria for consideration of the duodenal switch procedure, there is no evidence that the patient has undergone a psychological evaluation to determine whether she is an appropriate candidate for weight loss surgery.Based upon the information set forth above, I have determined that the requested procedure is medically necessary for treatment of the patients medical condition depending upon the results of a psychological evaluation. Therefore, the Health Plans denial should be overturned. If the psychological evaluation indicates the patient is an appropriate candidate for weight loss surgery, the duodenal switch procedure should be authorized. If the psychological evaluation indicates the patient is not an appropriate candidate for weight loss surgery the duodenal switch procedure should not be authorized.
Appeal type: Medical Necessity
Decision: Upheld

A 45-year-old female enrollee requested Acthar gel injections for medical treatment of the enrollees health condition.  Findings:  The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested medication.  This patients disease, variously described in the medical records as lupus, undifferentiated connective tissue disease, and mixed connective tissue disease, is characterized by pleural effusion, pericardial effusion, ascites, renal disease of unknown classification and stage, and pulmonary hypertension.  The medical records do not support the requested medication in this clinical setting.  In the progress notes, she is described as being in no distress with stable vital signs.  She is on a low dose of prednisone and is on Plaquenil.  The clinical notes do not document auscultation of the heart or lungs or describe a recent chest x-ray, so the degree of pleural or pericardial effusion present cannot be assessed from the medical records. There is no documentation of recent radiographic studies that would help to determine the amount of serositis in this patient.  The patients polyserositis might be treated with higher-dose oral corticosteroids, parenteral corticosteroids, or immunosuppressants such as azathioprine or mycophenolate.  There is no evidence of nephrotic syndrome which may be treated with Acthar gel.  All told, the requested Acthar gel injections are not medically indicated for the treatment of this patient.
Appeal type: Experimental/Investigational
Decision: Upheld

A 51-year-old female enrollee has requested growth hormone therapy (Genotropin) for the treatment of the enrollees hypopituitarism. Findings:  Three physician reviewers found that there is not enough evidence to support that the patient has pituitary growth hormone deficiency. The documentation provided suggests low IGF-1 deficiency. IGF-1 deficiency can be seen in conditions other than pituitary dysfunction, such as malabsorption and malnutrition, liver disease, and other catabolic states. Additional endocrine evaluation would be needed to establish pituitary growth hormone deficiency. If she indeed has hypothalamic adrenal insufficiency and hypothalamic hypothyroidism, the criteria for treatment under FDA approval will be fulfilled and GH treatment would be indicated. Osteoporosis is associated with GH deficiency but it is not an indication for GH therapy. Most studies that show positive evidence of GH therapy in catabolic states or aging, for example, caution that there are not enough safety studies regarding the doses and effects of GH therapy.
Appeal type: Medical Necessity
Decision: Upheld

The patient has requested authorization and coverage for valganciclovir one to two weeks a month every three months x 2, gammaglobulin injections, antivirals for HSV 6 gastrointestinal infection, and/or voriconazole for 30 days. The patients records report a variety of non-specific symptoms including fatigue, headache, and neck pain. There is a lack of clinical findings consistent with a diagnosis of Epstein-Barr virus (EBV), a gastrointestinal infection, or aspergillosis. There is a report of an elevated EBV immunoglobulin G (IgG), which is a common finding that suggests a past infection. There is inadequate clinical documentation of a current EBV infection. The provider referred to the patients diagnosis as colitis, which is not supported in the records provided for review. Moreover, although aspergillosis causes several types of pulmonary infections, this patients records do not include evidence of a clinical aspergillus infection. Overall, there is an absence of an indication for valganciclovir, gammaglobulin, antivirals, and voriconazole. Therefore, the requested valganciclovir one to two weeks a month every three months x 2, gammaglobulin injections, antivirals for HSV 6 gastrointestinal infection, and voriconazole for 30 days are not medically necessary for 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 subspecialty 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: Medical Necessity
Decision: Upheld

A 60-year-old female enrollee requested repeat epidural injection, herniated discs (L2-3) and discs bulge (L3-4) for medical treatment of the enrollees lumbar radiculopathy.  Findings:  The physician reviewer found that review of the submitted documentation and relevant literature fails to demonstrate the medical necessity of the requested services. The clinical documentation submitted for review indicates that the patient received a transforaminal epidural steroid injection at the L2-3 and L3-4 that initially provided complete pain relief. Subsequently, the patient was examined with increasing pain complaints.  It was noted that a different approach would be taken in an attempt to provide pain relief to the patient; a recommendation was made for lumbar interlaminar epidural steroid injection. However, according to the American Academy of Pain Medicine there is not a significant difference between a transforaminal and interlaminar approach. Therefore, a different result would not be expected from an injection with a different approach. As the patient did not have a significant response to the initial injection, it is unclear how an additional injection would assist in avoiding surgical intervention. Furthermore, the patients most recent clinical evaluation did not provide any physical findings of radiculopathy correlating with the nerve pathology identified on the MRI. There is no documentation of motor strength weakness, sensation deficits, or decreased reflexes. Therefore, an additional epidural steroid injection would not be supported by the peer-reviewed literature. As such, the request for repeat epidural injection, herniated discs (L2-3) and discs bulge (L3-4) is not medically necessary.
Appeal type: Experimental/Investigational
Decision: Upheld

A 51-year-old female enrollee requested intraoperative radiation therapy for medical treatment of the enrollees breast cancer.   Findings:  Three physician reviewers found that the current medical evidence has not established the superior efficacy of intraoperative radiation therapy in this clinical setting.  External beam radiation therapy is the current standard of care.  The American Society for Radiation Oncology (ASTRO) published a consensus statement on accelerated partial breast irradiation.  The ASTRO Task Force noted that a patient belongs in a cautionary group if specific criteria are met.  In this patients case, she meets two criteria.  Specifically, her age is between 50 and 59 and she has a diagnosis of invasive lobular carcinoma.  The consensus noted that these criteria should result in caution when considering accelerated partial breast irradiation.  At this time, the data regarding the use of intraoperative radiation therapy is limited.  Therefore, intraoperative radiation therapy was not likely to be more efficacious than other alternatives.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Zepatier 50-100 mg. 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. This recommendation applies to all patients, regardless of fibrosis stage. The guidelines recommend that treatment-naive genotype 1a patients should be treated with regimens including or Zepatier for 12 weeks when NS5A resistance is not found. These guideline recommendations are based on clinical trial results showing a 99% cure rate when NS5A resistance is absent; if it is present, Zepatier and ribavirin are needed for 16 weeks. NS5A resistance testing results are not provided, so the medical necessity of Zepatier monotherapy for 12 weeks cannot be established. For these reasons, the request Zepatier for 12 weeks is not supported as 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 Physician 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

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for monitored anesthesia care provided. Findings:  The physician reviewer found that the submitted documentation supports the medical necessity of the services at issue.  The patient reported that she was intolerant of opiates.  The use of monitored anesthesia care and propofol for sedation during colonoscopy is a controversial topic.  There have been many reviews regarding the use of propofol in the United States which have resulted in differing opinions.  There is great regional variation in use.  In this case, the patient has a specific intolerance to opiates, which would be a major component of the usual sedation regimen of opiate and benzodiazepine.  Using benzodiazepine alone would not be very efficacious and much higher doses would be required.  Because of this intolerance, a propofol sedation approach was indicated.  All told, monitored anesthesia care provided on the date of dispute was medically indicated for the treatment of this patient.  Final Result: The reviewer determined that the services at issue were 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 anesthesiology 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 66-year-old male enrollee has requested ablation surgery for treatment of his history of palpitations.   Findings:  The physician reviewer found that while paroxysmal atrial fibrillation by nature occurs randomly and may last for brief periods of time, this is not a valid basis for not having a current/past EKG which clearly shows the arrhythmia. Ablation therapy is a procedure during which the pulmonary veins are ablated from a percutaneous approach by various techniques, with success rates approaching 70% after one attempt. It is typically reserved for patients who have failed medical therapy or remain severely symptomatic with their arrhythmia.  In this case, the Health Plan appropriately offered a 30-day event monitor in order to increase the yield that an episode of atrial fibrillation is detected.  Based upon the submitted documentation, the requested ablation surgery is not medically indicated for the treatment of this patient at this time.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/ Case Summary:  The enrollee is requesting reimbursement for in home nursing care services (CPT S9124) at a frequency of 40 hours per week. The enrollee has spinal muscular atrophy and acute and chronic respiratory failure.  She is dependent with activities of daily living (ADLs) and instrumental activities of daily living (IADLs) and is on feeding and aspiration precautions. She is at risk for skin breakdown due to her immobility, is wheel-chair bound and requires total care.  She was hospitalized for respiratory failure.  She cannot reposition herself; increasing her risk for decubitus ulcers. She requires multiple respiratory interventions throughout the day, such as supplemental oxygen when she desaturates, continuous pulse oximetry, nebulizer treatments and a CoughAssist machine to help expand her lungs and clear airway secretions. She uses a bi-level positive airway pressure (BIPAP) during the night, while asleep. According to the medical literature, private duty nursing services are considered medically necessary for patients who are confined to the home, the services are being provided under the treating practitioner's plan of care, and the services being provided require the professional proficiency skills of an RN or LPN/LVN and are not considered custodial in nature. Skilled services are services that have the potential to change a patients condition and require the knowledge and skill to identify and evaluate the patients need for possible modification of treatment or initiation of additional medical procedures until the patients clinical condition and/or treatment regimen have stabilized. The documentation indicates the enrollee was receiving care to include  vital signs, monitoring with pulse oximeter checks, nebulizer medications, cough assist care, BiPAP use, and supplemental oxygen when the enrollee desaturates.  There was insufficient evidence in the record the enrollee required services that could only be provided by skilled personnel, such as RNs or LPN/LVNs, after proper teaching.Final Result: The reviewer determined that the requested service is not medically necessary for the treatment of the enrollees medical condition. Credentials/Qualifications: The physician reviewer is board certified in physical medicine and rehabilitation and pediatric rehabilitation 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 similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned

The parent of a two-year-old male enrollee has requested  speech therapy for treatment of the enrollees speech delay.  Findings:  The physician reviewer found that this patient has an identified delay in expressive speech of greater than 50% per the DAYC subtest with severe difficulties with intelligibility and articulation. Consistent with the recommendations in the medical literature, speech therapy is indicated for patients who present with any delay greater than 25%. Extensive review of the literature including meta-analysis by Law and colleagues noted a positive effect of speech and language therapy interventions for children with expressive phonological and expressive vocabulary difficulty. Further, Volmar and Weisner noted that treatment for language disorders is predicated primarily on the childs language profile and level of communication skills. Overall, approximately 50% of children delayed at 2 years catch up to peers by 3 years of age while children with mild to moderate disorders are most likely to resolve their delay. In addition, the authors found that children treated with early intervention services with parental interaction and teaching demonstrated stronger language skills than those who did not receive early intervention. Moreover, children who participated in speech and language therapy showed better improvement when compared to their untreated peers. This patient continues to display expressive and receptive language impairment. Based on the foregoing discussion, the requested speech therapy has been shown to be a medically necessary intervention in the treatment of this patients medical condition and should therefore be approved.