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A 56-year-old female enrollee has requested reimbursement for a blood test performed on 11/24/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 3
A 56-year-old female enrollee has requested reimbursement for a blood test performed on 11/24/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that American College of Gastroenterology guidelines for dyspepsia support the use of Helicobacter pylori testing for evaluation of symptoms. The current medical literature supports the use of Helicobacter pylori testing to check for this infection as a cause for pain. Although alternative tests are available, a negative antibody test can rule out Helicobacter pylori infection as a cause for symptoms. In this case, in which the patient reported prior infection, the Helicobacter pylori antibody test can rapidly eliminate Helicobacter pylori infection as a cause for symptoms if negative, and establish the need for additional testing if positive. For these reasons, the blood test performed on 11/24/18 was likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy.
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A 67-year-old male enrollee has requested reimbursement for gene testing performed on 4/19/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees metastatic renal cell carcinoma.
The provider ordered somatic cancer mutational testing in an effort to decide the
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Upheld
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Experimental
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Summary Reviewer 3
A 67-year-old male enrollee has requested reimbursement for gene testing performed on 4/19/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees metastatic renal cell carcinoma. The physician reviewer found that metastatic renal cell cancer is resistant to conventional chemotherapy. The provider ordered somatic cancer mutational testing in an effort to decide the next best therapy. Patients with refractory or relapsed cancer that have exhausted standard treatments are usually considered for clinical trials. Recently, it has become important to identify mutations that may be amenable to targeted therapy. Von Hoff and colleagues performed a study of 86 patients where the progression-free survival on regimen selected by molecular profiling was compared to the progression-free survival on the last chemotherapy regimen. The regimen selected by molecular profiling offered a 27% survival advantage. In this patients case, VHL, MTOR mutations and CDKN2A/B loss were notable aberrations. This does suggest targeted therapy with an mTOR inhibitor may be utilized. Everolimus is an inhibitor of the mammalian target of rapamycin (mTOR) kinase, and placebo controlled clinical trials support its use in renal cell carcinoma. There is sufficient support for the services at issue in this clinical setting. Thus, gene testing performed on 4/19/16 was likely to have been more effective than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 50-year-old male has requested reimbursement for Anser IFX testing performed on 4/15/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
that the patient had fibrosis at the anastomosis leading to periodic small bowel obst
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Upheld
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Experimental
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Summary Reviewer 1
A 50-year-old male has requested reimbursement for Anser IFX testing performed on 4/15/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the Anser IFX was likely to have provided additional information for the management of this patients biologic therapy. If it was determined that the patient had fibrosis at the anastomosis leading to periodic small bowel obstruction, then surgery may have been advised. Postoperatively, the patient needed to be put on a biologic. There is sufficient support for the services at issue in this clinical setting. All told, Anser IFX testing performed on 4/15/15 was likely to have been more efficacious than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
patient is a 52-year-old female who presented with a left cheek basal cell cancer. The patient has requested authorization and coverage for brachytherapy. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 52-year-old female who presented with a left cheek basal cell cancer. The patient has requested authorization and coverage for brachytherapy. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. The physician reviewer found that guidelines do endorse the use of brachytherapy in the treatment of skin cancer. Brachytherapy uses a radioactive isotope to deliver therapeutic radiation near or inside the tumor target. In lesions on the face, due to the unique conformality of brachytherapy, there would be less scatter radiation to other nearby facial structures compared to other conventional radiation techniques using external beam radiation therapy. Brachytherapy would allow lower doses to the oral cavity and eye compared to standard techniques. Furthermore, in this case, brachytherapy may be preferentially used to allow for appropriate tumor coverage while allowing for normal tissue sparing. There is sufficient support for the requested services in this clinical setting. Therefore, brachytherapy is medically necessary for the treatment of this patient.
| 1 |
A 33-year-old female enrollee has requested reimbursement for exome sequence analysis (81415) provided on 8/15/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition.
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Upheld
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Medical Necessity
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Summary Reviewer
A 33-year-old female enrollee has requested reimbursement for exome sequence analysis (81415) provided on 8/15/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that the Society for Maternal-Fetal Medicine indicates that routine use of prenatal sequencing as a diagnostic test is not currently supported due to insufficient validation data and knowledge about its benefits and pitfalls. Although the technology is promising in genetic evaluation of an anomalous fetus, many challenges remain for the routine clinical use of exome sequencing. Interpreting results from exome sequencing is a very lengthy process, and is challenging due to reliance on phenotypic data that may be incomplete. Additionally, there are many counseling and ethical issues related to prenatal exome sequencing, including determining when to report secondary or incidental findings, the ongoing need for reanalysis of results, and the challenges of interpreting results in meaningful ways for patients. Therefore, given the complexities involved in interpretation of results, timeliness of results, and patient/family counseling, the decision to proceed with this type of testing should be made in consultation with a provider specializing in genetic testing, such as a certified genetic counselor or medical geneticist and is currently not the standard of care or medically necessary as in this case. Thus, CPT 81415 (exome sequence analysis) performed on 8/15/19 was not medically necessary for the evaluation of this patient.
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A 29-year-old female enrollee has requested reimbursement for the laboratory testing (CPT 86038, 86644, 82728, 82746, 82784, 85682, 84480, 84479, 80061, 82607, 36415, 86665, 86664, 83540, 83550, 80074, 86645, 86663, 82306, 84481, 80050, 86039, 81261, 81264, 81342, 81340, 84999, and 86790) provided on 8/16/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees body aches, low grade fever and fatigue.
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Upheld
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Medical Necessity
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Summary Reviewer
A 29-year-old female enrollee has requested reimbursement for the laboratory testing (CPT 86038, 86644, 82728, 82746, 82784, 85682, 84480, 84479, 80061, 82607, 36415, 86665, 86664, 83540, 83550, 80074, 86645, 86663, 82306, 84481, 80050, 86039, 81261, 81264, 81342, 81340, 84999, and 86790) provided on 8/16/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees body aches, low grade fever and fatigue. The physician reviewer found that according to the records provided for review, this patient presented with nerve tingling, headaches, muscle spasms, fatigue and body aches. The constellation of symptoms does not suggest the requested testing strategy was indicated for diagnosis of this patients medical condition. Specifically, the patient did not meet the standard clinical scenario for the evaluation of a lymphoproliferative disorder (Styczynski, et al; Ok, et al). Therefore, the laboratory testing (CPT 86038, 86644, 82728, 82746, 82784, 85682, 84480, 84479, 80061, 82607, 36415, 86665, 86664, 83540, 83550, 80074, 86645, 86663, 82306, 84481, 80050, 86039, 81261, 81264, 81342, 81340, 84999, and 86790) provided on 8/16/17 was not medically necessary for evaluation of the patients medical condition. Based on the foregoing discussion, the services at issue were not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
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A 55-year-old male enrollee has requested reimbursement for epidural injections of corticosteroid preparations (e.g., Depo-Medrol) with or without added anesthetic agents on 2/02/16 and 2/18/16. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition. The physician reviewer found that the patient has a history of lower back pain. Per the records, he has tried and failed conservative treatment, including physical therapy and pain medications, including Norco. The patient reported bilateral leg numbness and pain. Magnetic resonance imaging (MRI) findings showed severe central stenosis at L4-L5, with right-sided severe foraminal stenosis and moderate foraminal stenosis on the left. There was also possible mass effect on the left L4 and L5 nerve roots. The patient underwent lumbar transforaminal epidural steroid injections on 2/02/16 and 2/18/16.
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Overturned
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Experimental
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Summary Reviewer 2
A 55-year-old male enrollee has requested reimbursement for epidural injections of corticosteroid preparations (e.g., Depo-Medrol) with or without added anesthetic agents on 2/02/16 and 2/18/16. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition. The physician reviewer found that the patient has a history of lower back pain. Per the records, he has tried and failed conservative treatment, including physical therapy and pain medications, including Norco. The patient reported bilateral leg numbness and pain. Magnetic resonance imaging (MRI) findings showed severe central stenosis at L4-L5, with right-sided severe foraminal stenosis and moderate foraminal stenosis on the left. There was also possible mass effect on the left L4 and L5 nerve roots. The patient underwent lumbar transforaminal epidural steroid injections on 2/02/16 and 2/18/16. There is support for the services at issue in this clinical setting. Epidural steroid injections for lumbar radiculopathy and spinal stenosis is a widely accepted treatment for chronic lower back pain and radicular symptoms for patients that have failed conservative treatment options and/or patients that have undergone spine surgery and still have chronic back pain due to scar tissue and stenosis. In sum, epidural injections of corticosteroid preparations (e.g., Depo-Medrol) with or without added anesthetic agents on 2/02/16 and 2/18/16 were likely to have been more beneficial than other treatment options.
| 1 |
A 51-year-old female enrollee has requested reimbursement for the breast tomosynthesis provided on 7/13/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition.
In this case, the patient presented with heterogeneously dense breast tissue.
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Overturned
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Experimental
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Summary Reviewer 3
A 51-year-old female enrollee has requested reimbursement for the breast tomosynthesis provided on 7/13/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that Tomosynthesis is a technique that was developed as a problem solving adjunct to routine mammography. Patients who have dense breasts benefit most from breast tomosynthesis which has the ability to separate out the overlapping structures with the possibility of demonstrating an otherwise occult tumor. In this case, the patient presented with heterogeneously dense breast tissue. The ability to separate out superimposed tissue enables the possible delineation of an occult mass. In addition, the presence of asymmetry is also an indication for tomosynthesis. For this patient, tomosynthesis was utilized as a problem solving tool. Therefore, the breast tomosynthesis performed on 7/13/15 were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 59-year-old male enrollee has requested authorization and coverage for Orthovisc series (J7324 x 4). The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees knee pain.
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Overturned
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Medical Necessity
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Summary Reviewer
A 59-year-old male enrollee has requested authorization and coverage for Orthovisc series (J7324 x 4). The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees knee pain. The physician reviewer found the review of the submitted documentation and relevant literature demonstrates the medical necessity for the requested services. The peer-reviewed literature supports the use of hyaluronic acid injections, such as Orthovisc, for the treatment of knee osteoarthritis and indicates that these injections provide a longer lasting benefit than intra-articular corticosteroid injections. Given that the patients provider has advised against the use of intra-articular corticosteroid injections due to his hypertension, proceeding with corticosteroid injections would not be warranted or consistent with peer-reviewed literature. Therefore, the requested Orthovisc series x 4 is medically necessary for the treatment of the patients medical condition. For the reasons provided, the requested services are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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A 66-year-old female enrollee has requested authorization and coverage for gene testing provided on 12/28/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees cutaneous melanoma.
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Upheld
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Experimental
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Summary Reviewer 1
A 66-year-old female enrollee has requested authorization and coverage for gene testing provided on 12/28/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that the medical evidence does not support the superior efficacy of the services at issue in this clinical setting. The medical evidence shows that survival rates for melanoma vary based on the depth of invasion of the primary tumor. Based on the medical record provided the patients stage was a T3, and as such, a stage II. Stage II has an increased risk of recurrence. Multiple analyses have demonstrated that survival/prognosis is dependent upon tumor thickness, age at diagnosis, location of primary, presence of ulceration, mitotic rate, lymph node involvement, and growth pattern. Genomic and proteomic expression profiling has been under investigation, but the role in standard therapy has not been clearly outlined. DecisionDX melanoma is a commercial gene expression profile test which has been developed for patients with local (stage I and II) or locoregional (stage III) cutaneous melanoma. The most recent assessment was to determine the impact on clinical practice and therefore did not or was not able to discuss the impact on patient outcome. The National Comprehensive Cancer Network (NCCN) guidelines indicate that for stage II melanoma, wide excision be pursued with sentinel lymph node evaluation if the tumor is greater than 0.75 mm in thickness. For stage IIA, clinical trial or observation is recommended whereas for stage IIB or IIC, in addition to those options, interferon alpha should also be considered. There are no current recommendations to undergo genomic or proteomic analysis to assess risk or assess benefit of adjuvant therapy. Based on the review of the current guidelines, it is unclear that the addition DecisionDX melanoma improved this patients overall care plan since the role in clinical care is still undergoing investigation. In sum, the gene test performed on 12/28/15 was not likely to have been superior to the available options in the evaluation of this patients medical condition.Therefore, for the reasons stated above, the services at issue were not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 63-year-old male enrollee has requested reimbursement for an unlisted chemistry procedure performed on 7/27/17. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees malignant melanoma.
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Upheld
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Medical Necessity
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Summary Reviewer
A 63-year-old male enrollee has requested reimbursement for an unlisted chemistry procedure performed on 7/27/17. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees malignant melanoma. The physician reviewer found that the prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index has also been thought to add to these statistics. By Balch staging, this melanoma would be classified as a T1a, or stage 1A. As such, this patient would be expected to have at least an 88% ten-year survival. DecisionDx-Melanoma testing is a study of 31 genes in an individuals melanoma cells. It then classifies that particular melanoma as either Class I (90 to 92% five-year recurrence-free survival), or Class II (48 to 77% five-year recurrence-free survival). Gerami and colleagues reported on 217 cases, with good correlation between prognosis and DecisionDx-Melanoma classification, in patients undergoing sentinel node sampling. Berger and colleagues reported on 156 cases, but there was not sufficient follow-up to determine the actual value of the test. It is not clear how the five-year DecisionDx-Melanoma data compares to the Balch ten-year data. Most importantly, it is unproven as to whether the DecisionDx-Melanoma classification can be used to make clinical decisions, especially in patients with stage 1A disease. The current medical evidence does not support the services at issue in this clinical setting. All told, unlisted chemistry procedure performed on 7/27/17 was not medically necessary for the evaluation of this patient. Therefore, the services at issue were not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
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A 62-year-old male enrollee has requested reimbursement for testing for liver disease provided on 6/11/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 2
A 62-year-old male enrollee has requested reimbursement for testing for liver disease provided on 6/11/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that in chronic hepatitis B patients, such as this patient, identification of cirrhosis defines treatment endpoints and options. Non-invasive studies, such as FibroTest, are typically applicable to the hepatitis C population, and those with other chronic liver conditions. Relative to FibroTest itself, Jieanu and colleagues opined Fibrotest is a patented formula which involves several parameters: total bilirubin, haptoglobin, gamma glutamyl transpeptidase, a2-microglobulin apolipoprotein-A, age and gender, with the results correlated with the METAVIR score. This evaluation is the most used indirect marker showing excellent results in a meta-analysis in chronic hepatitis C (CHC). Supporting this contention, Parikh and colleagues concluded that FibroTest is useful in ruling out chronic hepatitis B-related cirrhosis. Thus, while liver biopsy remains the gold standard for assessment of hepatic fibrosis, the assay under review in this case provides ready assessment of progression to cirrhosis without the inherent risks of invasive testing. In sum, testing for liver disease (FibroTest-ActiTest/HCV-FibroSure) provided on 6/11/19 was likely to have been more beneficial than other methods of evaluating this patient.
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A 55-year-old female enrollee has requested authorization and coverage for botulinum toxin type A (Botox) treatment and ongoing treatment. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.
The documentation submitted for review documents the patient is diagnosed with chronic migraine headaches with at least 14 headache days per month. This patient has tried other prophylactic measures without success. In addition, Botox
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Overturned
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Experimental
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Summary Reviewer 1
A 55-year-old female enrollee has requested authorization and coverage for botulinum toxin type A (Botox) treatment and ongoing treatment. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The physician reviewer found that review of the submitted documentation and relevant literature supports the use of Botox injections in this clinical setting. According to the literature review by Szok and colleagues Recent clinical studies revealed that onabotulinumtoxinA was an efficacious and safe treatment for chronic migraine. The documentation submitted for review documents the patient is diagnosed with chronic migraine headaches with at least 14 headache days per month. This patient has tried other prophylactic measures without success. In addition, Botox is U.S. Food and Drug Administration (FDA) approved for the treatment of chronic migraine. For the reasons provided, the request for Botox injections and ongoing treatment are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 45-year-old male enrollee has requested authorization and coverage for bronchial thermoplasty. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees asthma.
records, this patient is unable to tolerate steroids (inhaled or otherwise). Also, the patient has undergone the evaluation and management of several alternative diagnoses (allergic disease, vocal cord dysfunction and reflux).
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Upheld
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Experimental
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Summary Reviewer 2
A 45-year-old male enrollee has requested authorization and coverage for bronchial thermoplasty. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees asthma. The physician reviewer found there is sufficient medical support for the requested procedure in this patients case. Clinical data demonstrates the short and long term benefits of bronchial thermoplasty for patients with severe asthma. The three initial trials of bronchial thermoplasty have demonstrated improved symptom control after the procedure was completed. Per the submitted records, this patient is unable to tolerate steroids (inhaled or otherwise). Also, the patient has undergone the evaluation and management of several alternative diagnoses (allergic disease, vocal cord dysfunction and reflux). Given the patients inability to tolerate an ideal medication regimen for his asthma, bronchial thermoplasty is an effective intervention. Thus, the requested procedure is an appropriate next step in management and treatment of the patients symptoms. As such, bronchial thermoplasty is likely to be superior over any available standard therapy for treatment of the patients medical condition. Based upon the information set forth above, the requested procedure is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 63-year-old female enrollee has requested reimbursement for FoundationOne CDx testing performed on 11/27/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
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Overturned
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Experimental
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Summary Reviewer 2
A 63-year-old female enrollee has requested reimbursement for FoundationOne CDx testing performed on 11/27/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that the use of next generation sequencing or molecular profiling is recommended by the National Comprehensive Cancer Network guidelines for patients with endometrial cancer. To date, molecular analysis of endometrial carcinoma has identified four clinically significant molecular subgroups with differing clinical prognoses: POLE mutations, microsatellite instability-high (MSI-H), copy number low, and copy number high. Ancillary studies for POLE mutations, mismatch repair (MMR)/MSI, and aberrant p53 expression are encouraged to complement morphologic assessment of histologic tumor type. Molecular analysis can help classify difficult cases and provide future therapeutic targets. Molecular targets can help distinguish the patientas eligibility for immunotherapy. Next generation sequencing such as with FoundationOne CDx can help identify therapeutic options both on and off of clinical trials and is a standard of care for patients with advanced endometrial cancer. Therefore, FoundationOne CDx testing performed on 11/27/20 was likely to have been more beneficial than other available standard therapy.
| 0 |
A 40-year-old male enrollee has requested reimbursement for nasopharyngoscopy, surgical, with
dilation of eustachian tube (i.e. balloon dilation); bilateral, on 8/26/21. The Health Insurer has
denied this request and reported that the service at issue was investigational for the treatment of
the enrollees bilateral eustachian tube dysfunction.
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Overturned
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Experimental
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Summary Reviewer 1
A 40-year-old male enrollee has requested reimbursement for nasopharyngoscopy, surgical, with
dilation of eustachian tube (i.e. balloon dilation); bilateral, on 8/26/21. The Health Insurer has
denied this request and reported that the service at issue was investigational for the treatment of
the enrollees bilateral eustachian tube dysfunction. The physician reviewer found that that balloon
dilation of the eustachian tube is supported in current medical literature and has been accepted as
a standard therapy in the otolaryngology community. Tucci and colleagues report that the
American Academy of Otolaryngology Head and Neck Surgery (AAO-HNSF) reports that
balloon dilation of the eustachian tube is an option for the treatment of patients with obstructive
eustachian tube dysfunction that is supported by multiple peer-reviewed studies. In a prospective,
multicenter, randomized controlled trial, Meyer and colleagues showed that eustachian tube
balloon dilation is a safe and effective treatment for persistent eustachian tube dysfunction based
on improved 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) scores. The authors
concluded, Balloon dilation is superior to continued medical management for persistent
eustachian tube dysfunction. In a prospective, multicenter, randomized, controlled trial, Poe and
colleagues concluded, This study demonstrated superiority of balloon dilation of the eustachian
tube with balloon catheter and medical management compared to medical management alone to
treat Eustachian tube dilatory dysfunction in adults. Regarding the long-term efficacy of balloon
dilation for treating patients with persistent Eustachian tube dysfunction, Cutler and colleagues
reported that balloon dilation results in durable improvements in symptoms and middle ear
assessments for patients with persistent eustachian tube dysfunction at mean follow-up of longer
than two years. In this case, the patient has eustachian tube dysfunction and had failed PE tube
placement and medical therapy. Repeat PE tube placement was complicated by a history of
difficult in-office PE tube placement due to pain and syncope. In this clinical setting, the service
at issue was likely to have been more beneficial than standard therapy with continued medical
management. Therefore, nasopharyngoscopy, surgical, with dilation of eustachian tube (i.e.
balloon dilation); bilateral, on 8/26/21, was likely to have been more beneficial for treatment of
the patients condition than any available standard therapy.
| 1 |
A 60-year-old female enrollee has requested reimbursement for Prolia (denosumab) injection administered on 10/20/15. The Health Insurer has denied this request indicating that the medication at issue is considered investigational for treatment of the enrollees osteoporosis.
in the hip. The patient has severe osteoporosis as documented by a BMD below -3 in both femoral necks and prior peripheral fracture. The patients medical records indicate that she is at a
Moreover, the patient was on bisphosphonate (Atelvia) therapy and her BMD did not improve. The patient also has a history of gluten intolerance, which suggests that she
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Overturned
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Experimental
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Summary Reviewer 3
A 60-year-old female enrollee has requested reimbursement for Prolia (denosumab) injection administered on 10/20/15. The Health Insurer has denied this request indicating that the medication at issue is considered investigational for treatment of the enrollees osteoporosis. The physician reviewer found Prolia is approved by the Federal Drug and Administration for treatment of postmenopausal osteoporosis. It is anticipated that Atelvia will not provide the benefit of therapy given that the patient has poor absorption and her bone density has not improved in the hip. The patient has severe osteoporosis as documented by a BMD below -3 in both femoral necks and prior peripheral fracture. The patients medical records indicate that she is at a high risk for fracture and studies have shown that Prolia reduces the incidence of vertebral fractures by about 68%, hip fractures by about 40%, and nonvertebral fractures by about 20% over 3 years (Cosman et al). Moreover, the patient was on bisphosphonate (Atelvia) therapy and her BMD did not improve. The patient also has a history of gluten intolerance, which suggests that she might have a malabsorption factor, which makes oral bisphosphonates poorly absorbed and therefore ineffective. For all these reasons, the medication at issue was likely to be of more benefit for treatment of the patients osteoporosis than available standard therapy. Based upon the information set forth above, the medication at issue was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 28-year-old female enrollee has requested reimbursement for substance use residential treatment center services provided from 1/23/17 through 2/10/17. The Health Plan has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition.
By 1/22/17, the patient embraced recovery principles and was both active in treatment and motivated for sobriety. She was not experiencing withdrawal, or significant medical or psychiatric symptoms. She had a supportive family and a safe home environment. She had no prior history of chemical
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Upheld
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Medical Necessity
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Summary Reviewer
A 28-year-old female enrollee has requested reimbursement for substance use residential treatment center services provided from 1/23/17 through 2/10/17. The Health Plan has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found the substance use residential treatment center services provided from 1/23/17 through 2/10/17 were not medically necessary for treatment of the patients medical condition. Due to the lengthy history of substance use, a residentially based detoxification and preliminary introduction to chemical dependency treatment was safe, appropriate and consistent with good medical practice. Although addiction specialty services remained indicated, the clinical documentation does not demonstrate the medical necessity of treatment in a 24-hour supervised setting as of 1/23/17. By 1/22/17, the patient embraced recovery principles and was both active in treatment and motivated for sobriety. She was not experiencing withdrawal, or significant medical or psychiatric symptoms. She had a supportive family and a safe home environment. She had no prior history of chemical dependency treatment in a less restrictive setting such as anti-craving medication, community programming, outpatient specialty care, intensive outpatient services or partial hospitalization. In sum, there is a lack of evidence to suggest that comprehensive, evidence-based services provided in a less restrictive treatment setting would have been insufficient. Thus, the services at issue were not medically necessary for treatment of the patients medical condition. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 48-year-old male enrollee has requested reimbursement for polymerase chain reaction (PCR) testing performed on 7/15/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 3
A 48-year-old male enrollee has requested reimbursement for polymerase chain reaction (PCR) testing performed on 7/15/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The patient had negative serological testing. PCR testing is not the standard of care in making a diagnosis of Lyme disease. Testing can be effectively used on synovial fluid in cases of suspected Lyme arthritis and on cerebrospinal fluid (CSF) when there is suspicion of neurologic Lyme disease. In sum, PCR testing is not indicated unless there is clear serological evidence of Borrelia infection, which was not present in this case. Therefore, the PCR testing performed on 7/15/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
The parent of a five-year-old male enrollee has requested authorization and coverage for the SleepSafe bed with bedding. The Health Insurer has denied this request indicating that the requested equipment is not medically necessary for treatment of the enrollees medical condition.
The records indicate that the patient no longer fits in his current crib, and he as at a high risk of fall.
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Overturned
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Medical Necessity
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Summary Reviewer
The parent of a five-year-old male enrollee has requested authorization and coverage for the SleepSafe bed with bedding. The Health Insurer has denied this request indicating that the requested equipment is not medically necessary for treatment of the enrollees medical condition. The physician reviewer found the submitted documentation supports the requested equipment in this clinical setting. The records indicate that the patient no longer fits in his current crib, and he as at a high risk of fall. The medical records document the need for the requested SleepSafe bed in this clinical setting. It is medically indicated for the patient to have medical equipment designed to improve personal safety. All told, the requested SleepSafe bed with high rails and padded bumpers is medically indicated for the treatment of this patient. Therefore, the requested equipment is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
The parent of a 14-year-old female enrollee has requested reimbursement for subtalar arthroereisis provided on 12/11/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees bilateral moderate-to-severe pes planus.
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Upheld
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Experimental
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Summary Reviewer 1
The parent of a 14-year-old female enrollee has requested reimbursement for subtalar arthroereisis provided on 12/11/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees bilateral moderate-to-severe pes planus. The physician reviewer found that based on the current medical literature, it was not likely to be more beneficial for this patient to have undergone subtalar arthroereisis for treatment of bilateral flexible flatfoot than treatment with standard available options. There are as many as eight different implants that are utilized to correct valgus deformity that are inserted into the sinus tarsi. The use of sinus tarsi implants or subtalar arthrodesis as an alternative to Evans procedure is not well supported with a high incidence of failure of the implants to maintain correction, recurrence of pain and the need to remove the implants and convert to a more durable solution. In spite of the reported short-term positive benefit, the lack of durability in the prosthesis is reported in a number of studies with high rates of need for revision. The support in the literature for arthroereisis is in the form of case series studies, and the level of the support in the literature is weak. Consistent with these findings, the subtalar arthroereisis provided on 12/11/14 was not likely to have provided this patient with an improved health outcome beyond that expected with standard interventions. Based upon the information set forth above, I have determined the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 38-year-old female enrollee has requested reimbursement for substance use partial hospitalization program services provided from 8/22/16 through 8/26/16. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions.
. This patient presented with a low risk of harm. She had no current suicidal or homicidal ideation. She had passive suicidal thoughts, but no plan. In terms of functional status, the records documented moderate impairment. Due to her substance use, she was not fulfilling her responsibilities. She was having interpersonal conflicts with her husband over her substance use. The records documented the significant comorbidity of her ongoing substance use despite negative consequences. The documentation noted a moderately stressful recovery environment. There were conflicts in the patients relationship with her husband over her current substance use. The patients husband takes Tramadol, which is a significant trigger for the patient as she has recently abused this drug. However, she has a supportive environment. Her husband was described as supportive. She has a good relationship with her children and her stepmother. The patient had a significant response to past treatment. She was sober for 15 years, which is a substantial period of time. The records documented that the patient accepted her illness and was engaged in her recovery. She attended groups and psychotherapy. Based on these factors, the patient met the criteria for an intensive outpatient
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Upheld
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Medical Necessity
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Summary Reviewer
A 38-year-old female enrollee has requested reimbursement for substance use partial hospitalization program services provided from 8/22/16 through 8/26/16. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the services at issue. The Level of Care Utilization System for Psychiatric and Addiction Services (LOCUS) is a nationally accepted tool for determining the appropriate level of care. Based on LOCUS, partial hospitalization program services were not medically indicated. This patient presented with a low risk of harm. She had no current suicidal or homicidal ideation. She had passive suicidal thoughts, but no plan. In terms of functional status, the records documented moderate impairment. Due to her substance use, she was not fulfilling her responsibilities. She was having interpersonal conflicts with her husband over her substance use. The records documented the significant comorbidity of her ongoing substance use despite negative consequences. The documentation noted a moderately stressful recovery environment. There were conflicts in the patients relationship with her husband over her current substance use. The patients husband takes Tramadol, which is a significant trigger for the patient as she has recently abused this drug. However, she has a supportive environment. Her husband was described as supportive. She has a good relationship with her children and her stepmother. The patient had a significant response to past treatment. She was sober for 15 years, which is a substantial period of time. The records documented that the patient accepted her illness and was engaged in her recovery. She attended groups and psychotherapy. Based on these factors, the patient met the criteria for an intensive outpatient program during the dates of service in dispute. Thus, substance use partial hospitalization program services provided from 8/22/16 through 8/26/16 were not medically necessary for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 55-year-old transgender female enrollee has requested authorization and coverage for facial feminization surgery. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees gender dysphoria.
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Upheld
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Medical Necessity
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Summary Reviewer
A 55-year-old transgender female enrollee has requested authorization and coverage for facial feminization surgery. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees gender dysphoria. The physician reviewer found that gender reassignment traditionally includes psychotherapy, hormonal therapy, and surgery. This has been demonstrated as the most effective treatment for patients with gender dysphoria. The World Professional Association for Transgender Health has published guidelines and standards of care, including what they consider eligibility criteria for surgery. In this patients case, the records do not document a comprehensive psychiatric evaluation. Further, in studying the quality of life of transgender male to female individuals, one large scale study by Ainsworth and Spiegel suggested that facial feminization did not have a statistically significant outcome in mental health features in these patients. Therefore, the requested facial feminization surgery is not medically necessary for the treatment of this patient. Therefore, the requested services are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 47-year-old female enrollee has requested authorization and coverage for a positron emission tomography (PET) scan. The Health Insurer has denied this request indicating that the requested diagnostic procedure is not medically necessary for evaluation of the enrollees pulmonary blastoma.
recent PET/CT in April 2016 was negative and a follow-up CT of the chest showed no
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Upheld
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Medical Necessity
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Summary Reviewer
A 47-year-old female enrollee has requested authorization and coverage for a positron emission tomography (PET) scan. The Health Insurer has denied this request indicating that the requested diagnostic procedure is not medically necessary for evaluation of the enrollees pulmonary blastoma. The physician reviewer found that the use of PET/CT for surveillance in non small cell lung cancer is not supported by the National Comprehensive Cancer Network (NCCN) guidelines absent any clinical evidence of tumor recurrence or imaging finding on conventional studies suspicious for tumor. In this case, the patients most recent PET/CT in April 2016 was negative and a follow-up CT of the chest showed no sign of tumor recurrence. Together with negative serum tumor markers, the requested PET/CT is not medically necessary per NCCN guidelines which state that PET/CT is not routinely indicated for surveillance after definitive therapy. Thus, absent biochemical or conventional imaging findings suggestive of tumor recurrence, the requested PET/CT scan is not medically necessary for evaluation of this patients pulmonary blastoma. Based on the foregoing discussion, the requested diagnostic procedure is not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 44-year-old female enrollee has requested has requested reimbursement for magnetic resonance imaging (MRI) (CPT code 73221) performed on 5/16/16. The Health Insurer has denied this request indicating that the diagnostic procedure at issue was not medically necessary for evaluation of the enrollees bilateral shoulder pain.
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Upheld
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Medical Necessity
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Summary Reviewer
A 44-year-old female enrollee has requested has requested reimbursement for magnetic resonance imaging (MRI) (CPT code 73221) performed on 5/16/16. The Health Insurer has denied this request indicating that the diagnostic procedure at issue was not medically necessary for evaluation of the enrollees bilateral shoulder pain. The physician reviewer found the submitted documentation fails to establish the medical necessity of the diagnostic procedure at issue. The clinical documentation submitted for review does not demonstrate that the patient was treated with a trial of conservative therapy such as anti-inflammatory medications, rest, and physical therapy prior to the MRI. In sum, given the lack of support demonstrating the patient underwent a trial of conservative therapy, the MRI (CPT code 73221) performed on 5/16/16 was not medically necessary for evaluation of the patients medical condition. Therefore, the diagnostic procedure at issue was not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
patient is a seven-year-old female with a history of spinal muscular atrophy (SMA). The
patient has been diagnosed with decreased functional mobility and has been limited in all areas of
gross motor development. The patients provider has recommended a wheelchair power seat
elevation system. The Health Insurer has denied the services at issue as not medically necessary
for treatment of the patients medical condition.
demonstrates significant postural deviations
due to spinal weakness and neuromuscular scoliosis.
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Overturned
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Medical Necessity
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Summary
The patient is a seven-year-old female with a history of spinal muscular atrophy (SMA). The
patient has been diagnosed with decreased functional mobility and has been limited in all areas of
gross motor development. The patients provider has recommended a wheelchair power seat
elevation system. The Health Insurer has denied the services at issue as not medically necessary
for treatment of the patients medical condition. This denial is the subject of this appeal and
determination. The physician reviewer found that the mobility methods of pediatric patients with
neuromuscular disorders and impaired mobility include manual and power wheelchairs depending
on the patients ability to propel themselves and the risk of complications from their underlying
neurological condition. Power wheelchairs provide a means for pediatric patients with motor
impairment to achieve age-appropriate self-generated mobility that would not be possible without
assistance. Developmental benefits, including social, language, and cognitive skill development,
may be observed in young patients with motor disability who use power wheelchairs. This patient
requires seat elevation to perform daily activities at school and at home. The wheelchair power
seat elevation system would provide independence, safety, and efficiency for the patient in
everyday settings and activities. Additionally, the patients current wheelchair does not provide
proper femur, pelvic, or lumbar support. The patient demonstrates significant postural deviations
due to spinal weakness and neuromuscular scoliosis. The power chair elevation system will
provide appropriate positioning for the patient to help reduce musculoskeletal complications such
as worsening scoliosis, contractures, pain, and hip deformities. For these reasons, the requested
wheelchair power seat elevation system is medically necessary for treatment of the patient.
| 1 |
A 61-year-old female enrollee has requested reimbursement for Botox injections provided on 12/13/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees low back pain and spasms.
This patient had evidence of myofascial pain and spasms with no evidence of radiculopathy or myelopathy.
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Upheld
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Experimental
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Summary Reviewer 1
A 61-year-old female enrollee has requested reimbursement for Botox injections provided on 12/13/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees low back pain and spasms. The physician reviewer found that low back pain is a major cause of disability and can result in substantial morbidity. Botulinum toxin has been used successfully to alleviate pain for a number of conditions caused by muscle contractions or spasms. The medical evidence supports the use of Botox for low back pain and spasms. The study of Jazayeri and colleagues included 50 patients treated for four weeks, with 76% reporting relief. The authors found a low incidence of side effects and concluded that Botox is an effective treatment. This patient had evidence of myofascial pain and spasms with no evidence of radiculopathy or myelopathy. There was sufficient support for the requested services in this clinical setting. Therefore, Botox injections provided on 12/13/17 was likely to have been of greater benefit than other available treatment modalities. Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 62-year-old male enrollee has requested authorization and coverage for sodium fluoride (NaF) 18 positron emission tomography (PET) with computerized tomography (CT), whole body scan. The Health Insurer has denied this request indicating that the requested services not medically necessary for evaluation of the enrollees prostate cancer.
patient is highly at risk for bone metastasis and his rising PSA is concerning for additional skeletal metastases besides the treated T-12 lesion.
This patient had a previous NaF 18 PET/CT scan that located his metastatic lesion that was not appreciated on the technetium scan earlier.
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Overturned
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Medical Necessity
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Summary Reviewer
A 62-year-old male enrollee has requested authorization and coverage for sodium fluoride (NaF) 18 positron emission tomography (PET) with computerized tomography (CT), whole body scan. The Health Insurer has denied this request indicating that the requested services not medically necessary for evaluation of the enrollees prostate cancer. The physician reviewer found that there is support in the medical literature for the requested PET/CT scan in this clinical setting. The documentation indicates that this patient is highly at risk for bone metastasis and his rising PSA is concerning for additional skeletal metastases besides the treated T-12 lesion. It has been well documented in the medical literature that NaF 18 is far more sensitive than technetium 99M bone scan agents in the detection of metastatic disease to bone in patients with prostate cancer. This patient had a previous NaF 18 PET/CT scan that located his metastatic lesion that was not appreciated on the technetium scan earlier. Thus, the PET/CT using the more sensitive compound will represent the baseline study with which to compare for progressive metastatic bone disease. All told, NaF 18 PET/CT, whole body scan is medically necessary for the evaluation of this patients medical condition. Therefore, for these reasons, the requested services are medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be overturned.
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A 58-year-old male has requested authorization and coverage for proton beam therapy (77499). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees right tonsillar cancer.
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Upheld
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Experimental
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Summary Reviewer 2
A 58-year-old male has requested authorization and coverage for proton beam therapy (77499). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees right tonsillar cancer.The physician reviewer found that based on the submitted documentation, the requested proton beam therapy is not likely to be more beneficial photon-based intensity modulated radiation therapy for the treatment of the above patients tonsillar cancer. Compared to standard radiotherapy with photon intensity modulated radiation therapy, the benefit of proton beam therapy is that radiation dose is deposited more precisely on its target. This translates into a decrease in exposure of normal tissue in the low-dose to intermediate-dose range, but not in the high-dose range. Comparing dosimetric parameters, proton beam therapy will also appear superior than photon-based intensity modulated radiation therapy. However, this dosimetric benefit does not always translate into an actual clinical benefit to the patient. In this patients case, a comparison chart was submitted for proton beam therapy versus intensity modulated radiation therapy, and this showed decreased doses to the spinal cord, brainstem, lips, contralateral parotid gland, and esophagus with proton beam therapy. However, the doses listed for the intensity modulated radiation therapy plan were already under normal tissue tolerance. Thus, the dosimetric improvement with proton beam therapy is not likely to be clinically significant. In sum, the requested proton beam therapy (77499) is not likely to be more effective than other available treatment options. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 59-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus.
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Overturned
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Medical Necessity
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Summary Reviewer
A 59-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus. The physician reviewer found the review of the submitted documentation and relevant literature demonstrates the medical necessity of the requested medication. According to the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) recommendations for treating hepatitis C, 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. The peer-reviewed literature does not support denying treatment for HCV because the patient does not have an advanced stage disease. Moreover, the AASLD and IDSA recommendations for treating HCV recommend a daily fixed-dose combination of ledipasvir/sofosbuvir (Harvoni) for treatment-naive patients with HCV genotype 1 infection. Therefore, the request for Harvoni is medically necessary for treatment of the patients HCV. For the reasons provided, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 45-year-old male enrollee has requested authorization and coverage for bronchial thermoplasty. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees asthma.
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Upheld
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Experimental
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Summary Reviewer 1
A 45-year-old male enrollee has requested authorization and coverage for bronchial thermoplasty. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees asthma. The physician reviewer found that bronchial thermoplasty is not generally accepted as standard of care for treatment of asthma. This procedure continues to be experimental or investigational. Bronchial thermoplasty is a procedure that uses a bronchoscope probe/catheter to provide thermal energy to the smooth muscle of the airway. In a publication by Thompson and colleagues, there was no difference in lung function indices (forced expiratory volume in 1 second) between those patients in the bronchial thermoplasty group and the control group who had visits or admissions into the emergency room. While the provider stated that the patient has had progressive decrease in his quality of life, there is a lack of clinical support to indicate that bronchial thermoplasty would improve the long-term functional outcome of the patients medical condition. For these reasons, the requested procedure is not likely to be superior to standard treatments available for treatment of this patients medical condition. Based upon the information set forth above, the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 54-year-old female enrollee has requested reimbursement for advanced lipoprotein testing
performed on 4/15/22. The Health Insurer has denied this request and reported that the services
at issue were investigational for the evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 2
A 54-year-old female enrollee has requested reimbursement for advanced lipoprotein testing
performed on 4/15/22. The Health Insurer has denied this request and reported that the services
at issue were investigational for the evaluation of the enrollees medical condition. The physician
reviewer found that in this case, the patient has increased coronary risk. The American College
of Cardiology (ACC) and American Heart Association (AHA) guidelines for the management of
cardiac risk and dyslipidemia do not recommend routine performance of specialized tests in the
context of assessing coronary risk including coronary calcium quantification, coronary computed
tomography (CT) scanning, advanced lipoprotein analysis, genetic testing, and homocysteine.
Treatment changes or additions based on the results of screening with these specialized tests
have not been shown to improve cardiac outcomes over those achievable by treatment based
on standard risk factor profiling and basic lipid analysis. While results from some of these
specialized tests may be abnormal and considered independent risk markers for coronary
disease, there is a lack of data in controlled trials demonstrating outcome benefits from treating
routinely obtained abnormal results. Therefore, advanced lipoprotein testing performed on
4/15/22 was not likely to have been more beneficial for evaluation of the patients condition than
any available standard therapy.
| 0 |
A 32-year-old female enrollee has requested reimbursement for polymerase chain reaction testing performed on 4/12/21. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
This patient reported a fishy odor, and the provider noted white discharge on examination.
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Overturned
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Experimental
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Summary Reviewer 1
A 32-year-old female enrollee has requested reimbursement for polymerase chain reaction testing performed on 4/12/21. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that patients with vaginitis can be evaluated and treated with an examination, microscopy and/or cultures, depending on the patientas symptoms and findings. The exact process depends on the provider and the resources available at that particular office. This patient reported a fishy odor, and the provider noted white discharge on examination. The medical evidence supports the services at issue in this patientas case. The services at issue were standard of care option and are clinically appropriate, especially when the history and examination do not coincide. Therefore, polymerase chain reaction testing performed on 4/12/21 was likely to have been more beneficial for evaluation of the patientas condition than any available standard therapy.
| 1 |
An 18-year-old male enrollee has requested reimbursement and prospective authorization and coverage for applied behavioral analysis (ABA) therapy provided from 9/12/16 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees autism.
. In this case, the patient has a diagnosis of autism with repetitive, restricted and/or stereotypic behaviors. The patients maladaptive behaviors interfere with his activities of daily living,
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Overturned
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Medical Necessity
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Summary Reviewer
An 18-year-old male enrollee has requested reimbursement and prospective authorization and coverage for applied behavioral analysis (ABA) therapy provided from 9/12/16 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees autism. The physician reviewer found that ABA therapy is a medically appropriate intervention for the treatment of autism spectrum disorders, and remains one of the most evidence-based interventions available. In this case, the patient has a diagnosis of autism with repetitive, restricted and/or stereotypic behaviors. The patients maladaptive behaviors interfere with his activities of daily living, making it difficult for him to be successful in more generalized environments. ABA therapy has been recommended for treatment of the patients daily living skills in the areas of independent living, job skills, community skills, self-injurious behaviors, aggression and stereotypical behaviors. Moreover, the provider also recommends training for the parents, and other family members and caregivers that are involved in the patients care. The training is to be focused on increasing independent skills while fading direct and indirect prompts required to complete tasks. Based on the clinical documentation submitted for review, ABA therapy provided from 9/12/16 forward was and is medically necessary for treatment of the patients autism. Therefore, the services at issue were and are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 33-year-old female enrollee has requested reimbursement for 91037-26 (esophageal function test, gastroesophageal reflux test with nasal catheter intraluminal impedance electrode(s) placement, recording, analysis and interpretation) performed on 7/29/21. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that this patient has a history of obesity status post gastric bypass and cholecystectomy, who presented with dysphagia. The patient was taken for an urgent cholecystectomy and has had solid food dysphagia since. She describes predominantly solid food dysphagia but does not endorse particular difficulty with liquids. She was taken for an upper endoscopy, which revealed a 3 cm hiatal hernia and angulation in proximity of the surgical intervention, suggestive of possible obstructive process. The provider seeks surgical revision, given the patientas symptoms of abdominal pain, nausea and vomiting.
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Overturned
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Experimental
|
Summary Reviewer 2
A 33-year-old female enrollee has requested reimbursement for 91037-26 (esophageal function test, gastroesophageal reflux test with nasal catheter intraluminal impedance electrode(s) placement, recording, analysis and interpretation) performed on 7/29/21. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that this patient has a history of obesity status post gastric bypass and cholecystectomy, who presented with dysphagia. The patient was taken for an urgent cholecystectomy and has had solid food dysphagia since. She describes predominantly solid food dysphagia but does not endorse particular difficulty with liquids. She was taken for an upper endoscopy, which revealed a 3 cm hiatal hernia and angulation in proximity of the surgical intervention, suggestive of possible obstructive process. The provider seeks surgical revision, given the patientas symptoms of abdominal pain, nausea and vomiting. The requested testing has not been proven to be safe and effective based on well-designed randomized controlled trials and has not been shown to necessarily alter health outcomes. Therefore, 91037-26 (esophageal function test, gastroesophageal reflux test with nasal catheter intraluminal impedance electrode(s) placement, recording, analysis and interpretation) performed on 7/29/21 was not likely to have been more beneficial than any available standard therapy.
| 1 |
A 32-year-old female enrollee has requested authorization and coverage for bilateral breast reduction surgery. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees macromastia.
This patient has well-documented chronic back pain, neck pain, shoulder pain, breast pain, shoulder grooving, and intermittent intertrigo with failure of topical medical management and other
including analgesics. Further, her symptomatic macromastia has failed reasonable conservative management. Her photographs are supportive of her clinical functional deficit.
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Overturned
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Medical Necessity
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Summary Reviewer
A 32-year-old female enrollee has requested authorization and coverage for bilateral breast reduction surgery. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees macromastia. The physician reviewer found this patient satisfies the criteria from the American Society of Plastic Surgeons (ASPS) for the requested bilateral breast reduction surgery but not the requested suction assisted lipectomy. In the peer-reviewed medical literature, Coriddi and colleagues noted that documentation of a functional problem can be demonstrated with evidence of intertriginous infections, back and shoulder pain, shoulder notching, physical inactivity, dissatisfaction with breast appearance, poor sexual well-being, and poor psychosocial well-being. This patient has well-documented chronic back pain, neck pain, shoulder pain, breast pain, shoulder grooving, and intermittent intertrigo with failure of topical medical management and other reasonable conservative management including analgesics. Further, her symptomatic macromastia has failed reasonable conservative management. Her photographs are supportive of her clinical functional deficit. Based on this, her condition of macromastia is causing functional problems that would benefit significantly from reduction surgery. All told, breast reduction is well-known to be safe in the carefully selected patient and is appropriate based on the ASPS criteria for this patient. However, this is not the case for suction assisted lipectomy which is generally performed to improve the aesthetic appearance of the breasts. Based on the foregoing discussion, a portion of the requested services is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be partially overturned.
| 1 |
A 63-year-old male enrollee has requested reimbursement for the prostate ablation performed on 10/24/17. The Health Insurer has denied this request indicating that the procedure at issue was not medically necessary for treatment of the enrollees prostate cancer.
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Upheld
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Medical Necessity
|
Summary Reviewer
A 63-year-old male enrollee has requested reimbursement for the prostate ablation performed on 10/24/17. The Health Insurer has denied this request indicating that the procedure at issue was not medically necessary for treatment of the enrollees prostate cancer. The physician reviewer found that in the peer-reviewed medical literature, Tay and colleagues concluded that, focused ultrasound is technically feasible for focal prostate ablation and appears to have a favorable early safety and functional profile. However, the authors cautioned that further clinical trials are necessary to establish oncologic efficacy. Moreover, there is a lack of current data demonstrating that HIFU provides improved long-term benefits over active surveillance in patients with low-grade and low-stage prostate cancer. Given the recommendations based on the current scientific evidence, the prostate ablation performed on 10/24/17 was not medically necessary for treatment of this patients prostate cancer. Based on the foregoing discussion, the procedure at issue was not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
patient is a 38-year-old female with a history of hidradenitis suppurativa that has not responded adequately to multiple therapies, including topical and oral clindamycin, doxycycline, rifampin, cortisone injections, spironolactone, vitamin D and Humira. In a letter dated 11/30/20, the patientas provider reported that the patient was started on Otezla in combination with her Humira treatment in October of 2020 and has responded very well.
the patient is currently taking. She has a failed a number of other
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Overturned
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Medical Necessity
|
Summary Reviewer
The patient is a 38-year-old female with a history of hidradenitis suppurativa that has not responded adequately to multiple therapies, including topical and oral clindamycin, doxycycline, rifampin, cortisone injections, spironolactone, vitamin D and Humira. In a letter dated 11/30/20, the patientas provider reported that the patient was started on Otezla in combination with her Humira treatment in October of 2020 and has responded very well. The physician reviewer found that there is support for the requested medication in this clinical setting. Adalimumab (Humira) is the only U.S. Food and Drug Administration (FDA) approved therapy for hidradenitis suppurativa (HS), which the patient is currently taking. She has a failed a number of other commonly used drugs, many of which are listed in the North American HS treatment guidelines. Of note, apremilast (Otezla) is not listed within these guidelines published in 2019. However, there was one very small randomized controlled trial and also an open-label observational study evaluating Otezla as a treatment for HS, which both showed modest efficacy after 16-24 weeks of therapy. Given the modest benefit reported for Otezla in the literature, it would be medically reasonable to
continue this treatment for another two months to determine if there is any clinical benefit from the drug and reassess the need thereafter. Therefore, Otezla is medically necessary for the treatment of this patient.
| 1 |
A 38-year-old female has requested reimbursement for laboratory testing performed on 7/06/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who had a history of recurrent pregnancy loss.
. The records indicate that the patient had a history of two first trimester miscarriages and had the diagnosis of recurrent miscarriage.
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Upheld
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Experimental
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Summary Reviewer 1
A 38-year-old female has requested reimbursement for laboratory testing performed on 7/06/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who had a history of recurrent pregnancy loss. The physician reviewer found there is a lack of support for the services at issue in this clinical setting. The records indicate that the patient had a history of two first trimester miscarriages and had the diagnosis of recurrent miscarriage. The etiologies for recurrent miscarriage may include chromosomal, uterine structural, ovulatory, thrombophilias and immune factors or combinations of these factors. The obstetric complications most often associated with thrombophilias are miscarriage, stillbirth, and abruption. The American Society for Reproductive Medicine, in its Practice Committee Opinion, notes that screening for inherited thrombophilias may be appropriate when a patient has a personal history of venous thromboembolism in the setting of a non-recurrent risk factor (such as surgery) or a first-degree relative with a known or suspected high-risk thrombophilia. There is no evidence in the medical record that the patient has a personal or family history of a thrombophilia. Therefore, there is no support within the standard of care for inherited thrombophilia testing. In addition, the medical evidence indicates that there is no significant association between MTHFR and recurrent miscarriage. Therefore, MTHFR testing is not within the standard of care. In sum, laboratory testing performed on 7/06/15 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 56-year-old female enrollee has requested authorization and coverage for biliopancreatic bypass with duodenal switch (CPT code 43845). The Health Insurer has denied this request indicating that requested procedure is considered investigational for treatment of the enrollee, who has a history of morbid obesity and type 2 diabetes.
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Upheld
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Experimental
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Summary Reviewer 3
A 56-year-old female enrollee has requested authorization and coverage for biliopancreatic bypass with duodenal switch (CPT code 43845). The Health Insurer has denied this request indicating that requested procedure is considered investigational for treatment of the enrollee, who has a history of morbid obesity and type 2 diabetes. The physician reviewer found that there is support in the medical literature for the requested procedure in this clinical setting. Biliopancreatic bypass with duodenal switch is documented to be superior to medical management for treatment of weight loss. Duodenal switch is also associated with higher rates of diabetes remission, but there are some studies which link this procedure to higher rates of protein malnutrition. If the patient and her provider are prepared to deal with the potential outcomes that comes with this procedure, then biliopancreatic bypass with duodenal switch is an appropriate treatment option. As such, biliopancreatic bypass with duodenal switch (CPT code 43845) is likely to be more effective than the medical management options for treatment of this patients medical condition. Based upon the information set forth above, the requested procedure is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 62-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 3/05/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition.
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Upheld
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Medical Necessity
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Summary Reviewer
A 62-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 3/05/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that this patient had an early stage melanoma. The National Comprehensive Cancer Network guidelines state while there is interest in newer prognostic molecular techniques such as gene expression profiling to differentiate melanomas at low versus high risk for metastasis, routine prognostic genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study. Newer prognostic molecular techniques should not replace standard staging procedures. There is a lack of definitive data regarding its use for risk classification in patients with cutaneous melanoma. This test does not currently have a role in determining which patients are candidates for adjuvant immunotherapy, either as a standard of care or as part of clinical trials. Therefore, DecisionDx-Melanoma testing performed on 3/05/19 was not medically necessary for the evaluation of this patient.
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A 53-year-old female enrollee has requested reimbursement for gene testing performed on 11/15/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma.T
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Upheld
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Experimental
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Summary Reviewer 3
A 53-year-old female enrollee has requested reimbursement for gene testing performed on 11/15/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma.The physician reviewer found that the melanoma is a cancer that is curable in its earliest stages. Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76-1.0 mm. Metastases to regional lymph nodes may be amenable to excision, but this suggests a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha. The data on DecisionDx-Melanoma test has not made it part of routine analysis after sentinel lymph node biopsy. There has also been some lack of consistency between various genes being used as biomarkers. As such, the test is novel, and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. Thus, gene testing performed on 11/15/16 was not likely to have been more effective than other modalities for evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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patient is a 42-year-old female who has been diagnosed with myasthenia gravis. Per the submitted documentation, this causes difficulty with breathing and swallowing.
In this case, the patient has severe myasthenia gravis that affects her breathing and swallowing. She had an inadequate clinical response to other immunosuppressive treatments and has osteoporosis,
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 42-year-old female who has been diagnosed with myasthenia gravis. Per the submitted documentation, this causes difficulty with breathing and swallowing. The physician reviewer found that the 2012 American Academy of Neurology guidelines for intravenous immunoglobulin in the treatment of neuromuscular disorders recommends that IVIG should be considered in the treatment of myasthenia gravis. This recommendation was based on studies involving primarily moderately or severely affected patients. A retrospective study by Sorgun and colleagues investigated thirteen patients who had displayed an inadequate clinical response to immunosuppressive treatments, or who were not appropriate for immunosuppressive treatment due to the age factor and thus were given regular IVIG therapy. The number and severity of the attacks were decreased in all patients. The authors concluded, IVIG can produce repeated beneficial effects in patients with myasthenia gravis and may be useful as an adjunct in the management of myasthenia gravis. IVIG has minimal adverse effects and ability to reduce corticosteroid dose. In this case, the patient has severe myasthenia gravis that affects her breathing and swallowing. She had an inadequate clinical response to other immunosuppressive treatments and has osteoporosis, which could be exacerbated by the use of corticosteroids. Treatment with weekly IVIG has improved her symptoms. Based on the studies noted above, IVIG is a valid modality in this patient because it has decreased the number and severity of exacerbations and has allowed a decrease in her corticosteroid dosage. For these reasons, IVIG 500 mg twice per week is medically necessary for the treatment of this patient.
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A 21-year-old male enrollee has requested authorization and coverage for Consentyx Pen 150 mg. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees severe plaque psoriasis.
The patient has severe, disseminated, chronic plaque psoriasis that requires systemic treatment. He has failed treatment with standard therapies including Dovonex, Taclonex, and methotrexate.
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Overturned
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Medical Necessity
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Summary Reviewer
A 21-year-old male enrollee has requested authorization and coverage for Consentyx Pen 150 mg. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees severe plaque psoriasis. The physician reviewer found that Psoriasis is a chronic inflammatory skin disease that typically presents with sharply demarcated, inflammatory, erythematous plaques with characteristic silver-white scaling due to epidermal hyperproliferation and parakeratosis secondary to the inflammation (Marji, et al). Traditional systemic therapies for psoriasis, including methotrexate and cyclosporine, have a well-documented array of toxicities, particularly end-organ toxicities. Over the past several years, the use of anti-tumor necrosis factor (TNF) biologic therapies for the treatment of moderate to severe psoriasis has been a major clinical and research focus (Patel, et al). Cosentyx selectively binds to IL-17A, inhibiting its interaction with the receptor, thus inhibiting its downstream effects on keratinocytes in plaque psoriasis (Reich, et al). In addition, Cosentyx is approved by the U.S. Food and Drug Administration (FDA) for treatments of such patients (Gohil). The patient has severe, disseminated, chronic plaque psoriasis that requires systemic treatment. He has failed treatment with standard therapies including Dovonex, Taclonex, and methotrexate. Thus, the requested Cosentyx Pen 150 mg is medically necessary for treatment of this patients psoriasis. Consistent with these findings, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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A 62-year-old female has requested reimbursement gene testing performed on 11/01/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the patient with ovarian cancer received chemotherapy but debulking surgery revealed residual tumor. This suggests marked chemotherapy resistance. Her providers submitted her tumor specimen for mutational analyses to identify other therapies. Von Hoff and colleagues
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Upheld
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Experimental
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Summary Reviewer 2
A 62-year-old female has requested reimbursement gene testing performed on 11/01/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the patient with ovarian cancer received chemotherapy but debulking surgery revealed residual tumor. This suggests marked chemotherapy resistance. Her providers submitted her tumor specimen for mutational analyses to identify other therapies. Von Hoff and colleagues performed a study of 86 patients where the progression-free survival on regimen selected by molecular profiling was compared to progression-free survival on the last chemotherapy regimen. The regimen selected by molecular profiling offered a 27% survival advantage. This trial has very significant results for patients with stage IV tumors. In sum, the gene testing performed on 11/01/15 was likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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The parent of a 15-year-old enrollee has requested reimbursement for adolescent mental health residential treatment provided from 6/02/18 through 8/04/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions.
The medical records indicate that the patient was not actively suicidal. He did not engage in any self-harm behaviors but did have a reported history of suicidal ideation.
The patient has had issues with level of functioning due to mental illness in the past and relationship problems, but overall showed
the patient was stable while in the residential treatment center.
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Upheld
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Medical Necessity
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Summary Reviewer
The parent of a 15-year-old enrollee has requested reimbursement for adolescent mental health residential treatment provided from 6/02/18 through 8/04/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found that in terms of risk of harm, the records support a score of 2. The medical records indicate that the patient was not actively suicidal. He did not engage in any self-harm behaviors but did have a reported history of suicidal ideation. With regards to functional status, the records support a score of 3. The patient has had issues with level of functioning due to mental illness in the past and relationship problems, but overall showed appropriate daily functioning while in treatment, including cooperation in treatment and intact activities of daily living. In terms of comorbidity, the records support a score of 1. The patient did not have active medical problems or substance use that affected his primary psychiatric issues. With regards to level of stress of the recovery environment, the records support a score of 2. There is no indication of an unsafe home environment. In terms of level of support of the recovery environment, the records support a score of 2. The patients family was actively involved in treatment on a regular basis. With regards to resiliency and treatment history, the records support a score of 3. It appears that the patient was stable while in the residential treatment center. In terms of acceptance and engagement of the child, the records support a score of 2. The patient actively participated in therapy. With regards to acceptance and engagement of the parent, the records support a score of 2. The parents worked actively and constructively with clinicians on a regular basis. Therefore, the patient has a composite score of 17. This score correlates with intensive outpatient services. Therefore, adolescent mental health residential treatment provided from 6/02/18 through 8/04/18 was not medically necessary for the treatment of this patient.
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patient is a 52-year-old female who presented with a well-defined nodular mass at the left acromioclavicular joint. The provider ordered magnetic resonance imaging (MRI) of the chest for evaluation. The patient had no history of trauma, fever or known malignancy. The patient has requested reimbursement for the MRI of the chest without contrast provided on 11/15/17. The Health Insurer has denied this request indicating that the diagnostic procedure was not medically necessary.
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is a 52-year-old female who presented with a well-defined nodular mass at the left acromioclavicular joint. The provider ordered magnetic resonance imaging (MRI) of the chest for evaluation. The patient had no history of trauma, fever or known malignancy. The patient has requested reimbursement for the MRI of the chest without contrast provided on 11/15/17. The Health Insurer has denied this request indicating that the diagnostic procedure was not medically necessary. The acromioclavicular joint is a common location for prominent physical findings and is usually due to a hypertrophic osteophyte or old healed fracture. Plain x-rays are typically considered sufficient to evaluate such findings if present. Moreover, if these findings were demonstrated on plain x-rays, this would have negated the need for MRI. Thus, without the initial radiograph as a guide for further imaging, the MRI of the chest without contrast provided on 11/15/17 was not medically necessary for evaluation of this patients medical condition. Based on the foregoing, the diagnostic procedure at issue was not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
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A 53-year-old female enrollee has requested reimbursement for a sleep study performed on 12/19/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees insomnia.
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Upheld
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Medical Necessity
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Summary Reviewer
A 53-year-old female enrollee has requested reimbursement for a sleep study performed on 12/19/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees insomnia. The physician reviewer found the review of the submitted documentation and relevant literature fails to demonstrate the medical necessity of the services at issue. The patient presented with obesity, snoring and insomnia. Sleep onset insomnia is not an indication for a sleep study. Patients with sleep onset insomnia have a long sleep latency and patients with clinically significant sleep apnea have a short sleep latency. Moreover, the patients Epworth Sleepiness Scale score was normal. Thus, the patient did not have hypersomnia. Hypersomnia is the cornerstone for a diagnosis of sleep apnea. In addition, there was no documentation of witnessed sleep apnea or awakening gasping for breath. Furthermore, the patient did not have sleep apnea per sleep study. Based on the medical records submitted and the peer-reviewed literature, the sleep study performed on 12/19/14 was not medically necessary for evaluation of the patients medical condition. For the reasons provided, the services at issue were not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
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The patient is a 59-year-old female who was diagnosed with recurrent leiomyosarcoma of the uterus. A sample tissue was sent for genetic testing. The patient has requested reimbursement for the FoundationOne test performed on 11/14/16. The Health Insurer denied this request and reported that the services at issue were investigational for evaluation of this patients medical condition.
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Upheld
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Experimental
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Summary Reviewer 2
The patient is a 59-year-old female who was diagnosed with recurrent leiomyosarcoma of the uterus. A sample tissue was sent for genetic testing. The patient has requested reimbursement for the FoundationOne test performed on 11/14/16. The Health Insurer denied this request and reported that the services at issue were investigational for evaluation of this patients medical condition. To demonstrate the clinical utility of panel genetic testing, prospective randomized clinical trials are needed that compare the strategy of targeted treatment based on panel results with standard of care. At this time, there is a lack of such trials, which have been published. Currently recognized and accepted molecular evaluation and classification of soft tissue sarcoma (STS) include standard histological evaluation. Effective therapy for STS, including classification, is well summarized in the National Comprehensive Cancer Network (NCCN) guidelines. There is a lack of support in the literature for broad genomic panel testing. The available literature on clinical utility consists of a small number of uncontrolled studies and nonrandomized controlled trials that use imperfect comparators. This evidence is not sufficient to make conclusions as to the clinical utility of broad genetic testing. In addition, there is potential for harm if ineffective therapy is given based on test results because there may be adverse effects of therapy in the absence of a benefit. As a result, the use of expanded mutation panel testing for targeted treatment in cancer is considered unproven, For these reasons, the FoundationOne test performed on 11/14/16 was not likely to have been of greater benefit than other treatment modalities for evaluating this patient. Therefore, for the reasons stated above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 61-year-old female enrollee has requested authorization and coverage for positron emission tomography (PET) scan. The Health Insurer has denied this request indicating that the requested services are considered investigational for evaluation of the enrollees lung cancer.
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Overturned
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Experimental
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Summary Reviewer 3
A 61-year-old female enrollee has requested authorization and coverage for positron emission tomography (PET) scan. The Health Insurer has denied this request indicating that the requested services are considered investigational for evaluation of the enrollees lung cancer. The physician reviewer found that small cell lung carcinoma (SCLC) is an aggressive pulmonary neuroendocrine neoplasm. Typical treatment for limited stage SCLC typically involves a combination of chemotherapy and radiation therapy, as in this case. PET/CT combines functional/metabolic as well as anatomic information and is utilized in the setting of SCLC to guide initial treatment strategy or modify treatment. The National Comprehensive Cancer Network (NCCN) recommends post-treatment surveillance of non-surgical lung cancer with chest CT approximately every six months or more frequently in some cases. PET-CT is not routinely recommended in cases where there is no radiographic sign of disease. However, the guidelines state that it may be useful in assessing abnormalities seen on CT scan which are indeterminate, and may represent post-treatment changes or recurrence. In this case, the results of the patients most recent CT scan in May 2018 were suspicious for disease recurrence, although nonspecific. As stated in the NCCN guidelines, PET is the recommended next test to clarify inconclusive CT results and determine if biopsy is necessary. As biopsy is risky in this patient due to severe underlying lung disease, it should only be performed if absolutely necessary. Thus, the requested PET scan is likely to be more efficacious than other modalities for evaluating this patient. Based upon the information set forth above, the requested services are likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 30-year-old female enrollee has requested reimbursement for the Anser ADA serological markers performed on 8/21/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for treatment of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 3
A 30-year-old female enrollee has requested reimbursement for the Anser ADA serological markers performed on 8/21/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for treatment of the enrollees medical condition. The physician reviewer found that the use of biologics such as Humira in Crohns disease places patients at risk for potential serious side effects. This is important when a patient loses response to Humira, which requires increasing the dose. In this case, there is concern as the disease is quite advanced and the patient had already failed several regimes. Therapeutic levels and lack of antibodies may point the treating provider toward a different medication versus another etiology. Thus, testing for antibodies identifies the subset of patients who will benefit from an increased dose. Moreover, checking for antibodies helps optimize clinical response by helping achieve a more optimal drug concentration. All told, the Anser ADA serological markers performed on 8/21/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 33-year-old male enrollee has requested reimbursement for Prometheus Anser ADA diagnostic testing performed on 5/19/14. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees Crohns disease.
, the patient has Crohns disease and failed treatment with Cimzia and was switched to Humira. The patient had a better response to a higher dose.
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Upheld
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Experimental
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Summary Reviewer 3
A 33-year-old male enrollee has requested reimbursement for Prometheus Anser ADA diagnostic testing performed on 5/19/14. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees Crohns disease. The physician reviewer found in this case, the patient has Crohns disease and failed treatment with Cimzia and was switched to Humira. The patient had a better response to a higher dose. Hence, there was consideration for Humira failure or development of antibodies and consideration was being entertained to potentially switch to yet another biologic versus maintenance on a higher dose of Humira. To better guide the management, an ADA test was performed. Due to the multitude of management options once a patient has no response to Humira and the fact that Humira has a wide array of adverse effects, it is important for the treating provider to have a roadmap of the nature of the patients clinical course. ADA testing provides important and significant management implications, and was clinically indicated in this case given the suspicion for potential antibodies or lack of response. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 23-year-old female enrollee has requested reimbursement for inpatient hospital stay from 9/06/18 through 9/08/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition.
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Upheld
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Medical Necessity
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Summary Reviewer
A 23-year-old female enrollee has requested reimbursement for inpatient hospital stay from 9/06/18 through 9/08/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that this patient did not meet criteria for acute inpatient admission. She could have been safely and effectively managed under an observational level of care. Patients with uncontrolled diabetes with nausea, vomiting and blood sugars in the 300s do require observation to control blood sugars. However, acute inpatient admission is required when there is evidence of severe acidosis, evidence of end organ damage, persistent symptoms, electrolyte disturbances or altered mental status. There is no clinical evidence to support the patient meeting any of these requirements. Furthermore, there was no evidence of fetal distress or maternal hemodynamic instability to support acute inpatient admission. Therefore, inpatient hospital stay from 9/06/18 through 9/08/18 was not medically necessary for the treatment of this patient.
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A 63-year-old male enrollee has requested reimbursement for the Foundation One test performed on 3/13/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees metastatic poorly differentiated carcinoma.
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Upheld
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Experimental
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Summary Reviewer 1
A 63-year-old male enrollee has requested reimbursement for the Foundation One test performed on 3/13/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees metastatic poorly differentiated carcinoma. The physician reviewer found that the utility of the Foundation One testing has not been demonstrated to improve patient outcomes as compared to standard testing. According to the National Comprehensive Cancer Network (NCCN), to demonstrate clinical utility of panel genetic testing such as Foundation One, prospective randomized clinical trials are needed that compare the strategy of targeted treatment based on panel results with standard of care. The available literature on clinical utility consists of a small number of uncontrolled studies, and non-randomized controlled trials that use imperfect comparators. This evidence is not sufficient to make conclusions on clinical utility. As a result, the use of expanded mutation panel testing for targeted treatment in cancer should only be conducted in the setting of a clinical trial. For these reasons, the Foundation One test provided on 3/13/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 35-year-old female has requested reimbursement for Oncotype Dx Colon Cancer Assay provided on 11/16/18. The Health Insurer has denied this request indicating that the services at issue were investigational for the evaluation of the enrollees medical condition.
patients case, a tumor sample was submitted for Oncotype DX Colon Cancer Assay testing to help decide adjuvant chemotherapy. The Oncotype DX
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Upheld
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Experimental
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Summary Reviewer 3
A 35-year-old female has requested reimbursement for Oncotype Dx Colon Cancer Assay provided on 11/16/18. The Health Insurer has denied this request indicating that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that in this patients case, a tumor sample was submitted for Oncotype DX Colon Cancer Assay testing to help decide adjuvant chemotherapy. The Oncotype DX Colon Cancer Assay uses a reverse transcriptase-polymerase chain reaction assay for 12 genes in an algorithm that can be used to predict recurrence. The medical evidence for the test is excellent and sufficient to allow its use to estimate the risk of recurrence for stage II patients. However, current data does not support its use as a predictive marker for response to adjuvant treatment. As such, the National Comprehensive Cancer Network guidelines noted there are insufficient data to recommend use of multi-gene assay panels to determine adjuvant therapy. Thus, Oncotype DX Colon Cancer Assay performed on 11/16/18 was not likely to have been superior over other methods of evaluating this patient.
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A 37-year-old female enrollee has requested reimbursement for gene testing performed on 1/19/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 2
A 37-year-old female enrollee has requested reimbursement for gene testing performed on 1/19/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the current medical evidence supports the services at issue in this clinical setting. The advent of genetic testing and analysis has helped providers to better characterize the chances of malignancy and in this case suggested the need for surgery. There is sufficient support for the services at issue in this patients case. The services at issue provided information which aided in management. Therefore, gene testing performed on 1/19/15 was likely to have been of greater benefit than other modalities. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 65-year-old female enrollee has requested authorization and coverage for spinal surgery (CPT codes 22212, 63048, 22610, 20931, 63046, 22840, 22842, 22853, 22845, 22556, 22216, 63077, and 22614) and five (5) inpatient days. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees back pain.
The medical records indicate that this patient underwent previous lumbar and cervical fusion surgeries and presents with 50 degrees of kyphosis in the mid-thoracic spine.
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Upheld
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Medical Necessity
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Summary Reviewer
A 65-year-old female enrollee has requested authorization and coverage for spinal surgery (CPT codes 22212, 63048, 22610, 20931, 63046, 22840, 22842, 22853, 22845, 22556, 22216, 63077, and 22614) and five (5) inpatient days. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees back pain. The physician reviewer found that in the medical literature, Resnick and Groff noted that lumbar fusion is performed for the treatment of painful instability of the spine, usually manifest as chronic low back pain. The documentation available for review does not include evidence of any instability in the thoracic spine. Further, there is no severe stenosis or deformity. The medical records indicate that this patient underwent previous lumbar and cervical fusion surgeries and presents with 50 degrees of kyphosis in the mid-thoracic spine. However, 50 degrees of kyphosis is considered mild in the thoracic spine and does not support the need for fusion. (Chou, et al; Resnick). All told, the requested spinal surgery (CPT codes 22212, 63048, 22610, 20931, 63046, 22840, 22842, 22853, 22845, 22556, 22216, 63077, and 22614) and five (5) inpatient days is not supported as medically necessary for treatment of this patients back pain. Based on the foregoing discussion, he requested services are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 62-year-old male enrollee has requested reimbursement for laboratory testing (Fibrotest-Actitest) performed on 8/14/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 2
A 62-year-old male enrollee has requested reimbursement for laboratory testing (Fibrotest-Actitest) performed on 8/14/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found there is sufficient support for the services at issue in this clinical setting. It is standard of care in contemporary gastroenterology to use when possible noninvasive testing as a measure of hepatic fibrosis. Elastography is one such noninvasive technique whereby ultrasound imaging provides objective data to evaluate tissue elasticity or stiffness by measuring tissue displacement. When liver biopsy is undesired, FibroScan demonstrates greater accuracy, sensitivity, and specificity for predicting and discriminating minimal or no fibrosis from extensive fibrosis. FibroSure is more widely available than FibroScan, and represents a well-recognized community-standard approach to noninvasive assessment of hepatic fibrosis. In this patients case, the current medical evidence supports the services at issue. Thus, laboratory testing (Fibrotest-Actitest) performed on 8/14/15 was likely to have been more efficacious than other methods of evaluation. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 61-year-old female has requested authorization and coverage for 64568, 0466T and 95970. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees obstructive sleep apnea.
. She has obstructive sleep apnea. The records noted prior use of CPAP. However, the records
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Upheld
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Experimental
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Summary Reviewer 3
A 61-year-old female has requested authorization and coverage for 64568, 0466T and 95970. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees obstructive sleep apnea. The physician reviewer found that the submitted documentation fails to demonstrate the superior efficacy of the requested services. She has obstructive sleep apnea. The records noted prior use of CPAP. However, the records do not document attempts at helping the patient with tolerating the CPAP were exhausted. The clinical notes do not document that conservative treatment options have been exhausted, including oral appliance therapy. All told, the requested services (64568, 0466T and 95970) are not likely to be more effective than other treatment alternatives. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 57-year-old female enrollee has requested reimbursement and prospective authorization and coverage for Opsumit provided from 4/22/15 forward. The Health Insurer has denied this request indicating that the medication at issue was not and is not medically necessary for treatment of the enrollees pulmonary arterial hypertension.
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Upheld
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Medical Necessity
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Summary Reviewer
A 57-year-old female enrollee has requested reimbursement and prospective authorization and coverage for Opsumit provided from 4/22/15 forward. The Health Insurer has denied this request indicating that the medication at issue was not and is not medically necessary for treatment of the enrollees pulmonary arterial hypertension. The physician reviewer found Tracleer was the first endothelin receptor antagonist that was U.S. Food and Drug Administration (FDA) approved for the treatment of primary pulmonary hypertension. Letairis and Opsumit are other endothelin receptor antagonists that gained FDA approval in 2007 and 2013, respectively. Based on the FDA approvals, each of these medications has a similar profile and potential side effects. The FDA notes that each of the medications can cause liver damage and liver function has to be monitored. Each of these medications can cause fluid retention and are not to be used in patients with liver disease. However, there is a lack of data demonstrating that any of these three drugs is superior to the other two medications. Thus, the patients pulmonary arterial hypertension can be treated with either of the Health Insurers formulary medications, Tracleer or Letairis with equivalent efficacy. Therefore, the Opsumit provided from 4/22/15 forward was not and is not medically necessary for treatment of this patients pulmonary arterial hypertension.
| 0 |
A 60-year-old female enrollee has requested reimbursement for Prolia (denosumab) injection administered on 10/20/15. The Health Insurer has denied this request indicating that the medication at issue is considered investigational for treatment of the enrollees osteoporosis.T
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Overturned
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Experimental
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Summary Reviewer 1
A 60-year-old female enrollee has requested reimbursement for Prolia (denosumab) injection administered on 10/20/15. The Health Insurer has denied this request indicating that the medication at issue is considered investigational for treatment of the enrollees osteoporosis.The physician reviewer found scienific studies reveal that osteoporosis is an increasingly widespread condition, affecting 55% of Americans aged 50 and above. Of these, approximately 80% are women. Fractures are the most dangerous aspect of osteoporosis. They can lead to acute and chronic pain as well as increased mortality (Old and Calvert). A newer medication, denosumab (Prolia) is a fully human monoclonal antibody which has been approved for the treatment of osteoporosis, treatment-induced bone loss, bone metastases, multiple myeloma, and giant cell tumor of bone (McClung, et al). Studies support the use of Prolia for the treatment of postmenopausal women with osteoporosis who are at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapies. This patient met medical necessity criteria for Prolia, as she failed other anti-resportive therapies for her osteoporosis. Therefore, the medication at issue was likely to be more efficacious in treatment of the patients osteoporosis than any available standard of therapy. Based upon the information set forth above, the medication at issue was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 53-year-old female has requested reimbursement for advanced lipoprotein testing. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 1
A 53-year-old female has requested reimbursement for advanced lipoprotein testing. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found based on the submitted records, this patient presented with some coronary risk. In this circumstance, primary prevention guidelines for the management of cardiac risk and dyslipidemia have been established, are periodically updated by expert committees, and are endorsed by several national organizations. These guidelines currently do not recommend routine performance of specialized tests in the context of assessing coronary risk, including lipoprotein-associated phospholipase A2 (Lp-PLA2), sub-classifications of low-density lipoprotein (LDL), high-density lipoprotein (HDL) subclasses, lipoprotein (a), C-reactive protein, insulin, fibrinogen, genetic testing and homocysteine. Treatment change or addition based on the results of screening with these specialized tests has not been shown to improve cardiac outcome incremental to that achievable by treatment based on standard risk factor profiling and basic lipid analysis. Even though results of some of these specialized tests may be abnormal and considered independent risk markers for coronary disease, there is a lack of controlled trials that demonstrate outcome benefits by treating routinely obtained abnormal results. In sum, advanced lipoprotein testing performed on 3/15/16 was not likely to have been more efficacious than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
A 62-year-old female enrollee has requested reimbursement for the DecisionDx melanoma gene expression assay provided on 7/29/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees cutaneous melanoma.
this patient presents with a melanoma with a Breslows depth of 3.65 mm. This places her into at
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Upheld
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Experimental
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Summary Reviewer 1
A 62-year-old female enrollee has requested reimbursement for the DecisionDx melanoma gene expression assay provided on 7/29/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that this patient presents with a melanoma with a Breslows depth of 3.65 mm. This places her into at least stage 2 disease. In stage 2 disease the National Comprehensive Cancer Network (NCCN) guidelines dictate certain protocols for further diagnosis, staging and prognosis as well as treatment paradigms. The melanoma DecisionDx testing would not change the staging, guidelines or care of this patient. Therefore, the DecisionDx testing performed on 7/29/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
An 18-year-old male enrollee has requested reimbursement for psychiatric residential treatment provided from 11/05/12 through 12/06/12. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions.
This patient was admitted after having felt stressed at his boarding school. He did not feel he could fit in and cut and scratched himself from the stress. Per the medical records, he was cooperative in his treatment program. He had an episode of scratching when he felt stressed at the thought of returning to his old school. The patient was given a discharge diagnosis of major depressive disorder, in remission, and attention deficit/hyperactivity disorder.
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Upheld
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Medical Necessity
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Summary Reviewer
An 18-year-old male enrollee has requested reimbursement for psychiatric residential treatment provided from 11/05/12 through 12/06/12. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the services at issue. This patient was admitted after having felt stressed at his boarding school. He did not feel he could fit in and cut and scratched himself from the stress. Per the medical records, he was cooperative in his treatment program. He had an episode of scratching when he felt stressed at the thought of returning to his old school. The patient was given a discharge diagnosis of major depressive disorder, in remission, and attention deficit/hyperactivity disorder. These conditions could have been safely treated at a lower level of care. It appears that removing him from the stress of the boarding school was a main factor in his improvement, and this could have been accomplished in a setting other than residential treatment. His scratching and cutting appear to be more stress relief and do not appear to be specific attempts at suicide. All told, psychiatric residential treatment provided from 11/05/12 through 12/06/12 was not medically indicated for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 51-year-old female enrollee has requested reimbursement for polymerase chain reaction (PCR) performed on 3/18/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
In this case, the patient did have gonorrhea and chlamydia PCR, and this was covered by the Health Insurer
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Overturned
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Experimental
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Summary Reviewer 1
A 51-year-old female enrollee has requested reimbursement for polymerase chain reaction (PCR) performed on 3/18/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that per the medical evidence, PCR testing is appropriate and medically indicated when done to test for chlamydia, gonorrhea, and trichomonas. In this case, the patient did have gonorrhea and chlamydia PCR, and this was covered by the Health Insurer. However, multiple additional PCR
tests were done for various other vaginal organisms, some of which do not even cause infection. PCR testing for these organisms is not standard of care. Therefore, PCR testing performed on 3/18/19 was not likely to have been more beneficial than other methods of evaluating this patient.
| 1 |
A 28-year-old female enrollee has requested reimbursement for emergency services provided on 4/27/16. The Health Insurer has denied this request indicating the services at issue were not required on an emergent basis.
Upon review of the submitted medical records, the patient presented with a sunburn. She reported pruritis, but declined Benadryl. She denied fever, vomiting, headache, or weakness. The patients pain was rated at 5/10. No blistering of the skin was present. The patient denied any other systemic symptoms.
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Upheld
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Medical Necessity
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Summary Reviewer
A 28-year-old female enrollee has requested reimbursement for emergency services provided on 4/27/16. The Health Insurer has denied this request indicating the services at issue were not required on an emergent basis. The physician reviewer found at issue in this case is whether a prudent layperson in the patients circumstances would believe he or she was experiencing an emergency medical condition. California law defines an emergency medical condition as a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that the absence of immediate medical attention could reasonably be expected to result in any of the following: (1) Placing the patients health in serious jeopardy; (2) Serious impairment to bodily functions; (3) Serious dysfunction of any bodily organ or part. Review of the submitted documentation demonstrates that a prudent layperson would not have sought immediate medical attention on the date in question. Upon review of the submitted medical records, the patient presented with a sunburn. She reported pruritis, but declined Benadryl. She denied fever, vomiting, headache, or weakness. The patients pain was rated at 5/10. No blistering of the skin was present. The patient denied any other systemic symptoms. Based on the patients presenting complaints and symptoms, a prudent layperson in this circumstance would not reasonably believe she was suffering from a serious medical condition. In sum, the patient was not suffering from a serious medical condition that was likely to place the patients health in serious jeopardy, cause serious impairment to body functions or cause serious dysfunction to a body organ or part. Thus, the services provided on 4/27/16 did not meet prudent layperson criteria for emergency care.
| 1 |
A 44-year-old female enrollee has requested reimbursement for an AmniSure test that was performed on 4/7/14. The Health Insurer has denied this request indicating that the test at issue is considered investigational for evaluation of the rupture of the fetal membrane.
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Upheld
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Experimental
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Summary Reviewer 1
A 44-year-old female enrollee has requested reimbursement for an AmniSure test that was performed on 4/7/14. The Health Insurer has denied this request indicating that the test at issue is considered investigational for evaluation of the rupture of the fetal membrane. The physician reviewer found that AmniSure testing (placental alpha-microglobulin-1 measurement) is recommended as an adjunct to standard assessment of pooling, ferning and nitrazine testing of vaginal fluid when these tests are inconclusive. AmniSure is not recommended as a first line test. Studies examining the measurement of placental alpha-microglobulin-1 are mixed. While there is some data supporting the utility of the assay, others studies have noted false-positive rates of 1930% in patients with clinically intact membranes and symptoms of labor (ACOG Practice Bulletin). This patients records do not document standard testing with ferning/nitrazine prior to the AmniSure testing. All told, there is insufficient evidence supporting the superior efficacy of the AmniSure test over standard testing with ferning/nitrazine. Therefore, the AmniSure test performed on 4/7/14 was not likely to be more beneficial than the available standard for evaluating the patients medical condition. Based upon the information set forth above, the test at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 27-year-old male enrollee has requested authorization and coverage for LINX Reflux Management System (code 43284) and associated inpatient bed day. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition.
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Upheld
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Experimental
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Summary Reviewer 3
A 27-year-old male enrollee has requested authorization and coverage for LINX Reflux Management System (code 43284) and associated inpatient bed day. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that the current medical evidence has not established the superior efficacy of the requested services. Direct comparative studies between surgical interventions are needed to better assess the long-term safety and efficacy of this therapeutic intervention in patients. There is lack of randomized controlled trials comparing LINX with other surgical anti-reflux interventions, such as the Nissen fundoplication. Sheu and colleagues concluded that the long-term safety and efficacy of LINX remains to be determined by evaluating and investigating the safety, efficacy and durability of the intervention over time. Adverse events including erosion through the esophagus have been reported. Although the LINX device has been approved by the U.S. Food and Drug Administration, based on current evidence and medical literature, the technology has not met a consensus opinion or recommendation by medical societies and governing organizations. The requested service has not been rigorously tested in randomized controlled trials against other alternative therapies. Therefore, LINX Reflux Management System (code 43284) and associated inpatient bed day is not likely to be more beneficial than other available standard therapy.
| 0 |
A 66-year-old male enrollee has requested reimbursement for gene expression profiling of melanomas performed on 3/29/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma.
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Upheld
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Experimental
|
Summary Reviewer 1
A 66-year-old male enrollee has requested reimbursement for gene expression profiling of melanomas performed on 3/29/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that the prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index may add to these statistics. DecisionDx-Melanoma testing is an analysis of 31 genes in an individuals melanoma cells. It then classifies that melanoma based on the risk of metastasis in five years. Gerami and colleagues reported on 217 cases, with good correlation between prognosis and DecisionDx-Melanoma classification, in patients who have had sentinel node biopsy. It is not clear how the five-year DecisionDx-Melanoma data compares to the ten-year Balch data. Most importantly, it is also not at all clear if one can make clinical decisions on the basis of DecisionDx-Melanoma classification. Therefore, gene expression profiling of melanomas performed on 3/29/18 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 42-year-old male enrollee has requested authorization and coverage for radiofrequency neurolysis. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees low back and left lower extremity pain.
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Overturned
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Experimental
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Summary Reviewer 3
A 42-year-old male enrollee has requested authorization and coverage for radiofrequency neurolysis. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees low back and left lower extremity pain. The physician reviewer found that in the documentation available for review, the provider does not document a pain diary for a medial branch block performed prior to the previous radiofrequency ablation. The current peer-reviewed medical literature is clear about how a diagnostic medial branch block is supposed to be done prior to radiofrequency ablation with use of a pain to verify when the local anesthetic wore off (Derby, et al). In the absence of this information, the requested repeat radiofrequency ablation cannot be supported as likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 51-year-old female enrollee has requested authorization and coverage for Botox. The Health
Insurer has denied this request and reported that the requested service is investigational for the
treatment of the enrollee.
in this case, the patient has a history
of temporomandibular joint disorder which has been present for years. The records note that the
patient has failed treatment with warm compresses and NSAIDs but responded well to Botox
therapy of the masseters.
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Upheld
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Experimental
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Summary Reviewer 2
A 51-year-old female enrollee has requested authorization and coverage for Botox. The Health
Insurer has denied this request and reported that the requested service is investigational for the
treatment of the enrollee. The physician reviewer found that in this case, the patient has a history
of temporomandibular joint disorder which has been present for years. The records note that the
patient has failed treatment with warm compresses and NSAIDs but responded well to Botox
therapy of the masseters. Standard therapy currently consists of oral muscle relaxants to help
reduce muscle spasms, which relax all muscles in the body and therefore have significant side
effects in order to be effective, physical therapy, which may only provide temporary relief of a
few hours, and oral appliances, which may prevent dental wear without stopping the bruxism
that is the primary cause of the temporomandibular joint disorder. Current medical literature
supports the use of Botox for treatment for bruxism-induced temporomandibular joint disorder.
Botox treats the bruxism locally and works for three months at a time, allowing the patient three
months of relief following an injection. In this clinical setting, the use of Botox for the treatment
of temporomandibular joint disorder is more beneficial than standard treatment as patient's
condition is caused by bruxism and not cause by arthritis of the temporomandibular joint.
Therefore, Botox is likely to be more beneficial for treatment of the patients condition than any
available standard therapy.
| 1 |
The parent of 10-year-old male enrollee has requested reimbursement for biofeedback treatment services provided from 3/05/18 through 5/14/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 2
The parent of 10-year-old male enrollee has requested reimbursement for biofeedback treatment services provided from 3/05/18 through 5/14/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition. The physician reviewer found that biofeedback is a technique that enables an individual to learn how to change physiological activity for the purposes of improving health and performance. Neurofeedback is the type of biofeedback most often cited in research regarding attention deficit/hyperactivity disorder. There is an emerging body of evidence supporting its clinical use. Gonzalez-Castro and colleagues analyzed the efficacy of neurofeedback compared with pharmacological support and the combination of both. In this study, the participants executive control and cortical activation were assessed before and after treatment. The results indicated that the combined group obtained more benefits, and the neurofeedback group improved to a greater extent in executive control than the pharmacological support group. While this recent data has been encouraging, the meta-analysis by Cortese and colleagues noted evidence from well-controlled trials with probably blinded outcomes currently fails to support neurofeedback as an effective treatment for attention deficit/hyperactivity disorder. Goode and colleagues noted there are significant gaps in knowledge regarding the effectiveness of attention deficit/hyperactivity disorder nonpharmacologic treatments. In sum, although recent data has been encouraging, evidence for the use of biofeedback/neurofeedback is still lacking. Thus, biofeedback treatment services provided from 3/05/18 through 5/14/18 was not likely to be of greater benefit than other treatment options.
| 0 |
A 43-year-old male enrollee has requested reimbursement for injection(s), platelet rich plasma,
any site, including image guidance, harvesting, and preparation when performed, on 3/7/22.
The Health Insurer has denied this request and reported that the service at issue was
investigational for the treatment of the enrollees left elbow pain and bicipital tendinitis of the
left shoulder.
In this case, the patient is
a 43-year-old male with left common extensor tendinopathy and biceps tendinopathy. Notes
dated 9/23/21 reported that meloxicam and topical Voltaren were not helpful in reducing his
pain. Magnetic resonance imaging (MRI) of the elbow with contrast neurography dated 1/31/22
showed high signal intensity at the lateral aspect of the epicondyle and distal biceps. The
patient received an ultrasound guided left distal biceps tendon and left lateral epico
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Upheld
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Experimental
|
Summary Reviewer 1
A 43-year-old male enrollee has requested reimbursement for injection(s), platelet rich plasma,
any site, including image guidance, harvesting, and preparation when performed, on 3/7/22.
The Health Insurer has denied this request and reported that the service at issue was
investigational for the treatment of the enrollees left elbow pain and bicipital tendinitis of the
left shoulder. The physician reviewer found that there is insufficient medical literature
supporting the use of platelet rich plasma (PRP) injections in the treatment of lateral
epicondylitis and biceps tendonitis. In a metanalysis, Karjalainen and colleagues conclude,
Data in this review do not support the use of autologous blood or PRP injection for treatment
of lateral elbow pain. These injections probably provide little or no clinically important benefit
for pain or function (moderate-certainty evidence), and it is uncertain (very low-certainty
evidence) whether they improve treatment success and pain relief greater than 50%, or
increase withdrawal due to adverse events. Wong and colleagues report, Overall there is
limited robust evidence to recommend PRP therapy for tennis elbow. There is even less
evidence to support the use of PRP in patients with biceps tendonitis. In this case, the patient is
a 43-year-old male with left common extensor tendinopathy and biceps tendinopathy. Notes
dated 9/23/21 reported that meloxicam and topical Voltaren were not helpful in reducing his
pain. Magnetic resonance imaging (MRI) of the elbow with contrast neurography dated 1/31/22
showed high signal intensity at the lateral aspect of the epicondyle and distal biceps. The
patient received an ultrasound guided left distal biceps tendon and left lateral epicondyle
injection with PRP on 3/7/22. Notes dated 6/13/22 reported that the patients history of
glucose-6-phosphate dehydrogenase (G6PD) deficiency was the reason a PRP injection was
provided rather than a steroid injection. It is unclear why G6PD deficiency was a concern for not
utilizing corticosteroid injection when nonsteroidal anti-inflammatory drugs (NSAIDs) were
prescribed, which appear to have a higher degree of concern for exacerbating the patients
condition. Regardless of the patients medical history of G6PD deficiency, current medical
literature does not support the use of PRP over other standard, conservative treatment options
such as continued physical therapy. Therefore, injection(s), PRP, any site, including image
guidance, harvesting, and preparation when performed, on 3/7/22, was not likely to have been
more beneficial for treatment of the patients condition than any available standard therapy.
| 1 |
The parent of a 14-year-old female enrollee has requested reimbursement for mental health residential treatment center services provided from 11/16/16 through 12/6/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition.
, the patient was medically and psychiatrically stable. As of 11/16/16 the patient had stabilized and was eating appropriately. She was at 86% of her ideal body weight. Her medical status was intact and described as psychiatrically stable. She had some laboratory abnormalities that could have been addressed on an outpatient basis and she did not have unstable coexisting health problems. She was not exhibiting severe mood, anxiety or psychotic symptoms and was not engaging in
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Upheld
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Medical Necessity
|
Summary Reviewer
The parent of a 14-year-old female enrollee has requested reimbursement for mental health residential treatment center services provided from 11/16/16 through 12/6/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found the mental health residential treatment center services provided from 11/16/16 through 12/6/16 were not medically necessary for treatment of the patients medical condition. According to Mehler, Anorexia nervosa is a psychiatric disorder characterized by abnormal eating behaviors that results in weight loss and has serious potential medical consequences. Most of these complications are readily treatable if diagnosed and attended to early in the course of the illness. Outpatient treatment with modalities such as cognitive behavioral therapy (CBT) can be effective for significantly reducing relapse risk and increasing the likelihood of good outcomes compared with nutritional counseling in the treatment of anorexia nervosa (Bulik, et al). CBT is commonly used on an outpatient basis. Moreover, in most cases outpatient treatment is recommended with hospital admission indicated for those at risk of medical and/or psychological compromise (Hay, et al). In this case, the patient was medically and psychiatrically stable. As of 11/16/16 the patient had stabilized and was eating appropriately. She was at 86% of her ideal body weight. Her medical status was intact and described as psychiatrically stable. She had some laboratory abnormalities that could have been addressed on an outpatient basis and she did not have unstable coexisting health problems. She was not exhibiting severe mood, anxiety or psychotic symptoms and was not engaging in self-harm type behaviors. Based on the clinical documentation submitted for review, the patient could have been treated safely and effectively at a lower level of care as of 11/16/16. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 36-year-old female enrollee has requested authorization and coverage for Sunosi 75 mg tablet.
The Health Insurer has denied this request and reported that the requested medication is
investigational for the treatment of the enrollees idiopathic hypersomnia.
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Upheld
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Experimental
|
Summary Reviewer 2
A 36-year-old female enrollee has requested authorization and coverage for Sunosi 75 mg tablet.
The Health Insurer has denied this request and reported that the requested medication is
investigational for the treatment of the enrollees idiopathic hypersomnia. The physician reviewer
found that the current medical literature supports the use of solriamfetol (brand name Sunosi) as
successfully improving wakefulness in central disorders of hypersomnolence. In a phase 3 study,
Thorpy and colleagues reported that solriamfetol improved wakefulness on the Maintenance of
Wakefulness Test (MWT) and reduced Epworth Sleepiness Scale (ESS) scores in a large
population of patients with narcolepsy. The authors also noted the safety and tolerability profile of
solriamfetol. However, there is a lack of comparative studies showing that the requested
medication is superior to other available standard therapies. Therefore, Sunosi 75 mg tablet is not
likely to be more beneficial for treatment of the patients condition than any available standard
therapy.
| 1 |
patient is a 69-year-old male who has requested reimbursement for targeted genomic sequence analysis with Foundation One performed in January 2020. He was diagnosed with a stage IIIA melanoma of the right chest wall in 2014.
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Overturned
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Medical Necessity
|
Summary Reviewer
The patient is a 69-year-old male who has requested reimbursement for targeted genomic sequence analysis with Foundation One performed in January 2020. He was diagnosed with a stage IIIA melanoma of the right chest wall in 2014. The physician reviewer found that the National Comprehensive Cancer Network (NCCN) guidelines recommend that patients with metastatic melanoma have broader genomic profiling if feasible, especially if the test results might guide future treatment decisions or eligibility for participation in a clinical trial. If BRAF single-gene testing is the initial test performed, and is negative (as in this patient), clinicians should strongly consider larger next generation sequencing panels to identify other potential genetic targets. Consideration of broader genomic profiling is recommended if the test results might guide future treatment decisions or eligibility for participation in a clinical trial. There is sufficient support for the services at issue in this clinical setting. Therefore, targeted genomic sequence analysis performed on 1/24/20 was medically necessary for the evaluation of this patient.
| 1 |
A 41-year-old female enrollee has requested reimbursement for Anser IFX testing performed on 4/02/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
|
Upheld
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Experimental
|
Summary Reviewer 3
A 41-year-old female enrollee has requested reimbursement for Anser IFX testing performed on 4/02/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the use of Anser IFX to direct subsequent management has not been clinically proven to improve patient clinical outcomes or alter patient management in controlled clinical trials. The presence of antibodies alone does not necessarily result in loss of response to infliximab, nor have threshold levels been established. Studies have found that anti-infliximab antibodies can be transient, and disappear over time, with many patients who have these antibodies maintaining their response. Although loss of response to infliximab is common, and excessive doses are also given, there were no standard guidelines defining a therapeutic strategy at the time of testing. In sum, the superior efficacy of Anser IFX testing performed on 4/02/15 has not been established. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
A 55-year-old female enrollee has requested reimbursement for gene test (molecular profiling) performed on 2/18/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee who has a history of lung cancer.
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Overturned
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Experimental
|
Summary Reviewer 3
A 55-year-old female enrollee has requested reimbursement for gene test (molecular profiling) performed on 2/18/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee who has a history of lung cancer. The physician reviewer found the National Comprehensive Cancer Network (NCCN) guidelines recommend that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged. The NCCN guidelines strongly endorses broader molecular profiling with the goal of identifying rare driver mutations for which effective drugs may already be available, or to appropriately counsel patients regarding the availability of clinical trials. Broad molecular profiling is a key component of the improvement of care of patients with NSCLC. Multiplexed genotype testing allows an entire panel of genotypes of interest to be queried at a single time from a single tissue sample instead of doing the tests sequentially one by one. This is the most tissue efficient approach, particularly when dealing with small tumor samples. In addition, multiplexed genotyping is the most time efficient process for screening patients and thus to facilitate prompt treatment or protocol inclusion. For the treatment of patients with advanced NSCLC, broad molecular profiling, such as with Guardant360 testing, is considered a standard of care. Therefore, the gene test (molecular profiling) performed on 2/18/16 was likely to have been of more beneficial than any available standard method for the evaluation of this patients medical condition. Based upon the information set forth above, the services at issue were likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 0 |
The patient is a 62-year-old male who was diagnosed with a melanoma on his left parietal scalp with a Breslow depth of at least 1mm. The patients physician sent his tissue for molecular genetic testing to help determine the risk of spread of the tumor. The patient has requested reimbursement for the DecisionDx-Melanoma test (84999) performed on 1/12/17. The Health Insurer denied this request for reimbursement and reported that the services at issue were considered investigational for evaluation of this patient. In this case, the patient has a scalp/head melanoma.
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Upheld
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Experimental
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Summary Reviewer 2
The patient is a 62-year-old male who was diagnosed with a melanoma on his left parietal scalp with a Breslow depth of at least 1mm. The patients physician sent his tissue for molecular genetic testing to help determine the risk of spread of the tumor. The patient has requested reimbursement for the DecisionDx-Melanoma test (84999) performed on 1/12/17. The Health Insurer denied this request for reimbursement and reported that the services at issue were considered investigational for evaluation of this patient. In this case, the patient has a scalp/head melanoma. These cancers are associated with a lower yield on sentinel lymph node biopsy (SNLB). His tumor is transected at the base so the records do not provide an accurate Breslow depth but we know it is at least 1 mm. In order to be able to follow this patient most effectively in terms of risk of recurrence, a molecular study that shows the risk of recurrence would be most helpful. This study would help to stratify this patients risk of recurrence of his tumor after a wide resection. This patients risk would then be used to determine potential treatment and follow up. In this case, since the SNLB is likely to be negative and it would be difficult to obtain an accurate risk of recurrence, the DecisionDx-Melanoma assay was likely to yield a better result. A complete lymph node dissection is also more difficult in head tumors as they can involve extensive parotid or neck surgeries. All told, the results from DecisionDx-Melanoma test (84999) performed on 1/12/17 was likely to have been more efficacious than the standard options of evaluating this patients medical condition. Therefore, for the reasons stated above, the services at issue were likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 43-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 9/2/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees risk for breast cancer.
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Overturned
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Experimental
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Summary Reviewer 2
A 43-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 9/2/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees risk for breast cancer. The physician reviewer found that in the peer-reviewed medical literature, Skaane and colleagues found that the addition of three-dimensional digital breast tomosynthesis to two-dimensional full field digital mammography resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers. Thus, although additional studies are needed to confirm these findings, there is adequate data to support the utility of three-dimensional digital breast tomosynthesis in this clinical setting. For these reasons, the breast tomosynthesis performed on 9/2/16 was likely to be more beneficial for evaluation of this patients medical condition than any available standard therapy. Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 51-year-old female has requested reimbursement for genetic testing performed on 4/13/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma.
The physician reviewer found that the patient is a 51-year-old female with malignant melanoma. She had a pigmented lesion removed from her right pre-tibial region. The final pathology showed this was superficial spreading malignant melanoma of Breslow depth of 0.8 mm, Clark level IV, and without ulceration. A tumor sample was submitted for DecisionDx-Melanoma testing. The patient has requested reimbursement for genetic testing performed on 4/13/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient.
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Upheld
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Experimental
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Summary Reviewer 3
A 51-year-old female has requested reimbursement for genetic testing performed on 4/13/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma.
The physician reviewer found that the patient is a 51-year-old female with malignant melanoma. She had a pigmented lesion removed from her right pre-tibial region. The final pathology showed this was superficial spreading malignant melanoma of Breslow depth of 0.8 mm, Clark level IV, and without ulceration. A tumor sample was submitted for DecisionDx-Melanoma testing. The patient has requested reimbursement for genetic testing performed on 4/13/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient. Melanoma is a cancer that is curable in its earliest stages. Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76 to 1.0 mm. Metastases to regional lymph nodes may be amenable to excision, but this suggests a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha. The data on DecisionDx-Melanoma testing has not made it part of routine analysis after sentinel lymph node biopsy. There has also been some lack of consistency between various genes being used as biomarkers. As such, the test is novel, and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. Thus, genetic testing performed on 4/13/18 was not likely to have been more efficacious than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 50-year-old female enrollee has requested authorization and coverage for interstitial radiation
source application, complex, includes supervision, handling, loading of radiation source, when
performed. The Health Insurer has denied this request and reported that the requested service
is investigational for the treatment of the enrollees oligoprogressive hepatic disease.
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Upheld
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Experimental
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Summary Reviewer 3
A 50-year-old female enrollee has requested authorization and coverage for interstitial radiation
source application, complex, includes supervision, handling, loading of radiation source, when
performed. The Health Insurer has denied this request and reported that the requested service
is investigational for the treatment of the enrollees oligoprogressive hepatic disease. The
physician reviewer found that radioembolization has not been proven to yield superior survival
probabilities for management of non-small cell lung cancer. In this case, the records do not
indicate that the patient is symptomatic from her liver disease, for example, with pain secondary
to tumor bulk, requiring palliative measures to improve quality-of-life. Furthermore, the patients
disease has progressed outside of the liver and while treatment with radioembolization may
provide control of the liver disease, it would not address the progressive nodal disease. In this
case, the requested service is not likely to be more beneficial for the treatment of this patient
than standard management of transitioning to the next-line systemic therapy, or to a clinical trial,
as this would be a more comprehensive management approach that would address all of
patients sites of disease. Therefore, interstitial radiation source application, complex, includes
supervision, handling, loading of radiation source, when performed, is not likely to be more
beneficial for treatment of the patients condition than any available standard therapy.
| 1 |
A 45-year-old male enrollee has requested authorization and coverage for hybrid artificial disc replacement at L4-5 and fusion at L5-S1 (CPT codes 22558, 22851, 22585, 22845, 20930, 63090, 63091 and 77003). The Health Plan has denied this request indicating that the requested services are considered investigational for treatment of the enrollees low back pain.
In this case, the patient presents with low back pain radiating into the posterolateral left lower extremity to the foot. Clinical exam findings documented a normal neurologic presentation. There is imaging evidence of L4-5 and L5-S1 spondylosis, grade 1 retrolisthesis at L5-S1, Modic type 1 endplate changes, and mild bilateral neuroforaminal narrowing. A discogram was reportedly positive at L4-5 and L5-S1, but
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Upheld
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Experimental
|
Summary Reviewer 1
A 45-year-old male enrollee has requested authorization and coverage for hybrid artificial disc replacement at L4-5 and fusion at L5-S1 (CPT codes 22558, 22851, 22585, 22845, 20930, 63090, 63091 and 77003). The Health Plan has denied this request indicating that the requested services are considered investigational for treatment of the enrollees low back pain. The physician reviewer found the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The evidence based peer-reviewed literature does not support single-level artificial disc replacement in the setting of multilevel lumbar degenerative disc disease. In this case, the patient presents with low back pain radiating into the posterolateral left lower extremity to the foot. Clinical exam findings documented a normal neurologic presentation. There is imaging evidence of L4-5 and L5-S1 spondylosis, grade 1 retrolisthesis at L5-S1, Modic type 1 endplate changes, and mild bilateral neuroforaminal narrowing. A discogram was reportedly positive at L4-5 and L5-S1, but outcomes have not been found to be consistently reliable for the low back based upon recent studies (Eck, et al). In addition, a disc replacement adjacent to a fused spinal segment would represent a hybrid-type complex/construct of which there are a lack of long-term medical literature studies available. Therefore, the requested hybrid artificial disc replacement at L4-5 and a fusion at L5-S1 is not likely to be more beneficial for treatment of the patients medical condition than any available standard treatment. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 62-year-old female enrollee has requested authorization and coverage for Xeljanz.A review of the record indicates that the enrollee has been diagnosed with alopecia areata. In an
undated letter, the provider reported that the enrollee has tried squaric acid, Rogaine, and
intralesional Kenalog injections.The Health Insurer indicates that the requested medication is investigational for the evaluation of
the enrolleeas medical condition. Therefore, the Health Insurer has denied coverage for the
requested medication.
hair loss. This
patientas medical condition is severe. She has failed standard therapy with intralesional Kenalog,
squaric acid and Rogaine. Her provided has requested Xeljanz as the next most appropriate step in
therapy for her medical condition.
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Overturned
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Experimental
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Summary Reviewer 2
A 62-year-old female enrollee has requested authorization and coverage for Xeljanz.A review of the record indicates that the enrollee has been diagnosed with alopecia areata. In an
undated letter, the provider reported that the enrollee has tried squaric acid, Rogaine, and
intralesional Kenalog injections.The Health Insurer indicates that the requested medication is investigational for the evaluation of
the enrolleeas medical condition. Therefore, the Health Insurer has denied coverage for the
requested medication. The physician reviewer found that Alopecia areata is an autoimmune medical condition that causes disfiguring patchy hair loss. This
patientas medical condition is severe. She has failed standard therapy with intralesional Kenalog,
squaric acid and Rogaine. Her provided has requested Xeljanz as the next most appropriate step in
therapy for her medical condition. This immunosuppressant medication is accepted medical
therapy for this autoimmune medical condition. Xeljanz is an immune-modulating therapy, which
has been approved by the U.S. Food and Drug Administration (FDA) for multiple immunemodulated
diseases, including rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and
juvenile rheumatoid arthritis. The safety and efficacy of Xeljanz in alopecia areata is welldescribed
in current literature. Since this patient has failed standard therapy, Xeljanz is the
appropriate next step in therapy. Therefore, Xeljanz is likely to be more beneficial than other
available standard therapy.
| 1 |
A 30-year-old female enrollee has requested reimbursement for Prometheus Anser ADA (84999) provided on 10/14/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees inflammatory bowel disease (IBD).
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Upheld
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Experimental
|
Summary Reviewer 1
A 30-year-old female enrollee has requested reimbursement for Prometheus Anser ADA (84999) provided on 10/14/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees inflammatory bowel disease (IBD). The physician reviewer found that it has not yet been established in the medical evidence whether the use of threshold levels aid in the discrimination of treatment response, nor has the optimal timing of when to measure antibody levels been established, as in this patients circumstance. The Prometheus Anser IFX test is a quantitative measurement of serum infliximab (IFX) and anti-IFX antibodies, and the Anser ADA test assesses serum adalimumab (ADA) and anti-ADA antibodies. Antidrug antibodies develop in a substantial number of patients and may be responsible for acute drug infusion reactions as well as delayed hypersensitivity reactions. In a large percent of patients who develop antibodies, such antibodies may disappear after continued treatment. The reasons for therapeutic failures remain unclear. Some evidence exists that low serum levels of infliximab or adalimumab or the presence of IFX or ADA antibodies have an adverse effect on the clinical outcome of a patients response to treatment. However, there are few well controlled clinical trials to confirm that use of the Anser testing leads to improved patient outcomes or quality of life as opposed to the standard method of treatment. As such, the clinical utility of measuring drug antibody concentrations has not been established, and it has not been established how patient management would change based on test results. Limited retrospective evidence describes changes in management after measurement to anti-drug antibodies, but does not compare these management changes to those made in the absence of anti-drug antibody measurement. All told, Prometheus Anser ADA (84999) provided on 10/14/15 was not likely to have been more efficacious than other alternatives in evaluating this patients medical condition. Therefore, for the reasons stated above, the services at issue were not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 26-year-old female enrollee has requested reimbursement for DecisionDx testing performed on 4/28/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees cutaneous melanoma.
|
Upheld
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Experimental
|
Summary Reviewer 2
A 26-year-old female enrollee has requested reimbursement for DecisionDx testing performed on 4/28/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion. Metastases to regional lymph nodes may be amenable to excision but suggest an increased risk for the development of metastatic disease in the future (Balch, et al). The data on the DecisionDx test for melanoma does not support its routine use after sentinel lymph node biopsy. According to the National Comprehensive Cancer Network (NCCN), there has been a lack of consistency with various genes being used as biomarkers in this clinical setting. Thus, the DecisionDx testing performed on 4/28/17 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 31-year-old female enrollee has requested reimbursement for osteochondral knee autograft CPT code 27416 performed on 3/7/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee who had injured her left knee.
In this patients case, she had a single full thickness articular cartilage lesion in the weight bearing zone.
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Overturned
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Experimental
|
Summary Reviewer 3
A 31-year-old female enrollee has requested reimbursement for osteochondral knee autograft CPT code 27416 performed on 3/7/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee who had injured her left knee. The physician reviewer found there is evidence of the effectiveness of the osteochondral autologous transfer for patients with a single, traumatically caused grade III or IV femoral condyle deficit who are under 40 years of age and have an active lifestyle. Osteochondral autologous transfer (OAT) technique is a method used to slow down the development of osteoarthritis. In the article by Werner and colleagues, 152 OAT procedures were reviewed, of which 20 competitive athletes met inclusion and exclusion criteria. All patients underwent an accelerated rehabilitation program after their procedure. Return to sport was determined for all athletes. All athletes were able to return to sport at their previous levels and reported that they were satisfied or very satisfied with their surgical outcome and ability to return to sport. The medical literature shows promising results of this technique at medium to long term follow up. In this patients case, she had a single full thickness articular cartilage lesion in the weight bearing zone. According to the medical literature, this patient was likely to have benefitted from this procedure when compared to other methods of therapy. Accordingly, osteochondral knee autograft, CPT code 27416 performed on 3/7/17 was likely to have been more efficacious for the treatment of this patients medical condition than any other available treatment options. Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
The patient is a 52-year-old male who presented to his provider on 2/23/23. The patient reported
lumbar spine pain that radiated to the left hip/buttock. The patient has requested authorization and
coverage for total disc arthroplasty. The Health Insurer has denied this request and reported that
the requested service is not medically necessary for the treatment of this patient.
In this case, the
patient has intervertebral disc disorders with radiculopathy of the lumbar region. He presented with
lumbar spine pain radiating to the left hip/buttock, described as sharp and throbbing with numbness
and tingling to the anterior thigh, which increases with sitting and prolonged standing. The records
note gait disturbance off and on. An examination revealed intact strength and sensation.
|
Upheld
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Medical Necessity
|
Summary
The patient is a 52-year-old male who presented to his provider on 2/23/23. The patient reported
lumbar spine pain that radiated to the left hip/buttock. The patient has requested authorization and
coverage for total disc arthroplasty. The Health Insurer has denied this request and reported that
the requested service is not medically necessary for the treatment of this patient. This denial is the
subject of this appeal and determination. The physician reviewer found that the submitted
documentation does not support the medical necessity of the requested service. In this case, the
patient has intervertebral disc disorders with radiculopathy of the lumbar region. He presented with
lumbar spine pain radiating to the left hip/buttock, described as sharp and throbbing with numbness
and tingling to the anterior thigh, which increases with sitting and prolonged standing. The records
note gait disturbance off and on. An examination revealed intact strength and sensation. The U.S.
Food and Drug Administration (FDA) approves the use of ProDisc-L total disc replacement for
spinal arthroplasty in skeletally mature patients with degenerative disc disease at one or two
consecutive levels from L3 to S1. The FDA further notes that the patient should be skeletally
mature with no spinal growth remaining, have a condition in which pain is caused by wear-and-
tear on a spinal disc at one or two consecutive levels in the lumbar spine from L3 to S1, have no
more than grade 1 spondylolisthesis at the involved level(s), and have failed at least six months of
conservative treatment. The FDA notes that contraindications include active systemic or site
infection, osteopenia or osteoporosis, bony lumbar spinal stenosis, allergy or sensitivity to implant
materials, isolated radicular compression syndromes especially due to disc herniation, and stress
fracture in the lumbar spine. In this case, the patient presents with degenerative disc disease at the
requested L5-S1 level without instability and noted moderate disc space narrowing. He has tried
and failed extensive conservative care measures. However, the submitted records do not document
any DEXA scans to corroborate that the lumbar spine is free from osteopenia or osteoporosis with
a T-score (bone density measurement) of less than -1.0. Formica and colleagues report, The
optimal surgical indication is crucial to achieve excellent clinical and radiological outcomes.
According to the literature and to our experience, we underline the importance of a coronal
deformity less than 15 degree Cobb angle and a Roussouly type 1 or 2 as the profile of the most
well-suited patient for total disc arthroplasty. Our long-term results confirm the existing evidence
about efficacy and safety of total disc arthroplasty as a reliable option, in optimal surgery
indication, to treat degenerative disc disease. In this case, lumbar x-rays do not document the
coronal deformity and/or lack thereof with a Cobb angle of less than 15 degrees. Yue and
colleagues note, Long-term evidence supports lumbar total disc replacement as safe. The next-
generation activL Artificial Disc is more effective at preserving range of motion than first-
generation lumbar total disc arthroplastys (ProDisc-L and Charite) and offers a higher safety
profile. Other primary and secondary outcomes are similar between disc designs. Despite the use
of total disc replacement being a viable option for lumbar degenerative disc disease, in this clinical
setting, specific surgical requirements are not met. Therefore, total disc arthroplasty is not
medically necessary for the treatment of this patient.
| 1 |
The parent of an 11-year-old female enrollee has requested authorization and coverage for gene testing. The Health Insurer has denied this request indicating that the requested services are considered investigational for evaluation of the enrollees medical condition.T
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Overturned
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Experimental
|
Summary Reviewer 2
The parent of an 11-year-old female enrollee has requested authorization and coverage for gene testing. The Health Insurer has denied this request indicating that the requested services are considered investigational for evaluation of the enrollees medical condition.The physician reviewer found the medical evidence supports the requested gene testing in this clinical setting. In this patients case, her constellation of symptoms may represent atypical Gitelman syndrome or atypical Bartter syndrome. Gitelman syndrome is an autosomal recessive genetic kidney disorder that results in imbalance of ionic substances in the body such as potassium and magnesium. Patients may experience weakness and cramping, as well as fatigue, hypotension, and ventricular dysrhythmias. Bartter syndrome is also an autosomal recessive genetic kidney disorder that results in imbalance of electrolytes in the body. Patients may experience dehydration, constipation, polyuria, osteopenia, and sensorineural hearing loss. Identification of the underlying disorder will be beneficial to this patient for future medical management. Therefore, the requested gene testing is likely to be superior over other methods of evaluating this patient. Based upon the information set forth above, the requested services are likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 0 |
A 65-year-old male enrollee has requested reimbursement for collagen crosslink testing performed on 7/11/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
In this case, the test provided information regarding the response to Prolia therapy.
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Overturned
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Experimental
|
Summary Reviewer 2
A 65-year-old male enrollee has requested reimbursement for collagen crosslink testing performed on 7/11/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found there is sufficient support for the services at issue in this clinical setting. The National Osteoporosis Foundation approves the use of biochemical markers of bone turnover as a tool to investigate causes of osteoporosis and then as a follow-up test to monitor response and compliance with antiresorptive therapy. This test may be done to assess response to therapy sooner than the one- to two-year follow-up dual-energy x-ray absorptiometry (DEXA) scan study that quantifies response in bone density measurements. In this case, the test provided information regarding the response to Prolia therapy. The significant reduction of the C-telopeptide level is consistent with excellent response to antiresorptive therapy with Prolia. In sum, collagen crosslink testing performed on 7/11/15 was likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 0 |
The patient is a 56-year-old transgender female who has been diagnosed with gender dysphoria. The patient has requested authorization and coverage for facial feminization surgery. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient.
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Overturned
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Medical Necessity
|
Summary Reviewer
The patient is a 56-year-old transgender female who has been diagnosed with gender dysphoria. The patient has requested authorization and coverage for facial feminization surgery. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. The physician reviewer found that the current medical evidence supports the requested services in this clinical setting. Ainsworth and Spiegel demonstrated that facial feminization surgery, like genital surgery, aimproved mental health-related quality of life.a The World Professional Association for Transgender Health position statement states, aNon-genital surgical proceduresanotably facial feminization surgeryaare often of greater practical significance in the patientas daily life than reconstruction of the genitalsaThese reconstructive procedures are not optional in any meaningful sense, but are understood to be medically necessary for the treatment of the diagnosed condition.a There is sufficient support for the requested services in this patientas case. Therefore, the requested facial feminization surgery is medically necessary for the treatment of this patient.
| 1 |
A 49-year-old female has requested authorization and coverage for 22857 [total disc
arthroplasty (artificial disc), two-day inpatient stay]. The Health Insurer has
denied this request and reported that the requested services are investigational for
the treatment of the enrollees medical condition.
|
Overturned
|
Experimental
|
Summary Reviewer 1
A 49-year-old female has requested authorization and coverage for 22857 [total disc
arthroplasty (artificial disc), two-day inpatient stay]. The Health Insurer has
denied this request and reported that the requested services are investigational for
the treatment of the enrollees medical condition. The physician reviewer found that
the disc arthroplasty procedure has been in use for over a decade. Current medical
literature demonstrates that its outcomes are superior to fusion. In a randomized,
controlled, multicenter trial, Gornet and colleagues concluded that the group
receiving lumbar disc arthroplasty consistently demonstrated statistical superiority
versus fusion on key clinical outcomes including improved physical function, reduced
pain, and earlier return to work. In reviewing the five-year outcomes, the authors
reported that lumbar disc arthroplasty is a safe and effective treatment. Therefore,
22857 [total disc arthroplasty (artificial disc), two-day inpatient stay] is likely
to be more beneficial for treatment of the patient's condition than any available
standard therapy.
| 1 |
A 40-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 9/9/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees risk for breast cancer.
|
Overturned
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Experimental
|
Summary Reviewer 3
A 40-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 9/9/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees risk for breast cancer. The physician reviewer found that there is a lack of peer-reviewed literature that supports the use of three-dimensional breast tomosynthesis compared to currently available techniques, especially in a patient without an increased risk of breast cancer. Although breast tomosynthesis may be a promising technique, its clinical efficacy is yet to be substantiated in peer-reviewed literature. Thus, in this clinical setting, the use of the digital breast tomosynthesis performed on 9/9/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the service at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
The parent of a four-year-old male enrollee has requested authorization and coverage for 40 hours per week of applied behavioral analysis (ABA) therapy. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees autism spectrum disorder.
, the patient demonstrates delays in social, cognitive, adaptive and executive functioning deficits and continues to demonstrate maladaptive behaviors of aggression,
|
Overturned
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Medical Necessity
|
Summary Reviewer
The parent of a four-year-old male enrollee has requested authorization and coverage for 40 hours per week of applied behavioral analysis (ABA) therapy. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees autism spectrum disorder. The physician reviewer found the Health Insurer has authorized 25 hours per week of ABA services. Several studies recommend 25 or more hours of weekly ABA to ensure optimal outcomes (Roane et al; Myers et al). The Behavior Analyst Certification Board states that typical comprehensive ABA programs range from 30 to 40 hours of treatment per week. In this case, the patient demonstrates delays in social, cognitive, adaptive and executive functioning deficits and continues to demonstrate maladaptive behaviors of aggression, physical stereotypy and perseveration. In this clinical setting, 40 hours per week of ABA therapy is medically necessary for treatment of the patients medical condition. Therefore, the requested services are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
The parent of a 12-year-old male enrollee has requested authorization and coverage for functional electrical stimulation RT300 therapy system. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollees incomplete paraplegia.
|
Overturned
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Experimental
|
Summary Reviewer 2
The parent of a 12-year-old male enrollee has requested authorization and coverage for functional electrical stimulation RT300 therapy system. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollees incomplete paraplegia. The physician reviewer found transversemyelitis is a neurological disorder caused by inflammation across both sides of one level of the spinal cord. The inflammation can damage or destroy myelin. Symptoms of transverse myelitis include a loss of spinal cord function. What usually begins as a sudden onset of lower back pain, muscle weakness, or abnormal sensations in the toes and feet can rapidly progress to more severe symptoms, including paralysis, urinary retention, and loss of bowel control. Although some patients recover from transverse myelitis with minor or no residual problems, others have permanent impairments that affect their ability to perform tasks of daily living. Functional electrical stimulation applies small electrical pulses to paralyzed muscles to restore or improve their function. Functional electrical stimulation is used in neurologically impaired individuals, including those with spinal cord injury and stroke, to stimulate muscles during activity. Per the medical evidence, functional electrical stimulation can minimize contractures and can decrease spasticity. The current medical evidence supports the requested device in this clinical setting. In sum, the requested functional electrical stimulation RT300 therapy system is likely to be superior over other treatment alternatives. Based upon the information set forth above, the requested device is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 64-year-old female enrollee has requested placement of permanent sacral nerve stimulator performed on 12/09/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees fecal incontinence.
ya and colleagues reported results of 50 patients implanted with sacral
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Overturned
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Experimental
|
Summary Reviewer 1
A 64-year-old female enrollee has requested placement of permanent sacral nerve stimulator performed on 12/09/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees fecal incontinence. The physician reviewer found the current medical evidence supports the services at issue in this clinical setting. There is clinical data to support the long-term efficacy and safety of the services at issue for the treatment of bowel dysfunction. Wexner and colleagues published results of a prospective multicenter study of sacral nerve stimulation for fecal incontinence. The authors concluded that sacral nerve stimulation using InterStim is a safe and effective treatment for patients with fecal incontinence. Moya and colleagues reported results of 50 patients implanted with sacral nerve stimulators. After six months, sacral nerve stimulation significantly improved fecal incontinence and positively impacted quality of life. All told, the permanent sacral nerve stimulator provided on 12/09/14 was likely to have been superior over other treatment modalities. Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 60-year-old male enrollee has requested reimbursement for St. Jude Nanostim Leadless Pacemaker implant provided on 6/24/15. The Health Plan has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition.T
|
Upheld
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Experimental
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Summary Reviewer 3
A 60-year-old male enrollee has requested reimbursement for St. Jude Nanostim Leadless Pacemaker implant provided on 6/24/15. The Health Plan has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition.The physician reviewer found The services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Despite the potential advantages of a leadless device, the long-term data demonstrating safety in large clinical follow-up is lacking. There have also been documented complications of the leadless device. In sum, there is a lack of data supporting the long-term safety and efficacy of the services at issue to establish the St. Jude Nanostim Leadless Pacemaker implant as likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.
Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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During the dates of service in dispute, both her mood and behavioral problems had improved. Per the records, she was medically stable, following directions, taking medication, and did not have aggressive, suicidal, or disruptive behaviors. She did not exhibit active suicidal ideations. She had a greatly reduced incidence of purging, although she did continue to have some restricting and purging behaviors.
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Upheld
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Medical Necessity
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Summary Reviewer
I am board certified in psychiatry and I am actively practicing. I am 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. In addition, I hold a current certification by a recognized American medical specialty board in the area or areas appropriate to the treatment under review. I have no history of disciplinary action or sanctions against my license. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the services at issue. During the dates of service in dispute, both her mood and behavioral problems had improved. Per the records, she was medically stable, following directions, taking medication, and did not have aggressive, suicidal, or disruptive behaviors. She did not exhibit active suicidal ideations. She had a greatly reduced incidence of purging, although she did continue to have some restricting and purging behaviors. The intensity of her symptoms could have reasonably been treated at a less invasive level of care. All told, mental health intensive outpatient services from 11/03/15 through 12/24/15 were not medically indicated for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 46-year-old female enrollee has requested reimbursement for breast magnetic resonance imaging (MRI) with computer aided detection performed on 11/10/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollee, who has a history of left breast ductal carcinoma in situ.
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Upheld
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Medical Necessity
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Summary Reviewer
A 46-year-old female enrollee has requested reimbursement for breast magnetic resonance imaging (MRI) with computer aided detection performed on 11/10/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollee, who has a history of left breast ductal carcinoma in situ. The physician reviewer found there is a lack of support for the services at issue in this clinical setting. Breast MRI has an important role in both screening and diagnostic settings. MRI studies of the breast are highly sensitive, but have a relatively low level of specificity. In some studies, the specificity of breast MRI has been reported to be as low as 37%. There is a lack of evidence to support the use of MRI as a surveillance tool rather than conventional mammography. Concerning DCIS, there is considerable literature which suggests that the term carcinoma should be dropped when describing these changes. Often, DCIS is characterized as stage 0, or a pre-cancerous condition. The National Comprehensive Cancer Network (NCCN) has recommended routine follow-up physical examinations and regular follow-up mammography for surveillance following a diagnosis of DCIS. The NCCN does not recommend follow-up surveillance MRI. In this case, there has been no submitted information which would warrant routine use of MRI for this patient. All told, breast MRI with computer aided detection performed on 11/10/15 was not medically indicated for the evaluation of this patient. Therefore, the services at issue were not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
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A 41-year-old male enrollee has requested reimbursement for elastase pancreatic fecal and fecal calprotectin laboratory testing performed on 8/03/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 2
A 41-year-old male enrollee has requested reimbursement for elastase pancreatic fecal and fecal calprotectin laboratory testing performed on 8/03/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that the records do not document the superior effectiveness of the services at issue. Fecal calprotectin is a useful test as a quantitative measure of inflammation within the gastrointestinal tract. It is useful to distinguish patients with irritable bowel syndrome versus inflammatory bowel disease and can allow patients to avoid unnecessary colonoscopy. However, this patient underwent this test the year before, and the records do not demonstrate the need to repeat this test. In sum, fecal calprotectin laboratory testing performed on 8/03/18 was not likely to have been more beneficial than other methods of evaluating this patient.
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