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A 37-year-old female has requested authorization and coverage for Gammagard liquid 10% vial. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollee, who has a history of recurrent pregnancy loss. | Upheld | Experimental | Summary Reviewer 1
A 37-year-old female has requested authorization and coverage for Gammagard liquid 10% vial. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollee, who has a history of recurrent pregnancy loss. The physician reviewer found that although this therapy has been studied extensively for this purpose, it is not considered effective or appropriate outside of experimental protocols. Branch and colleagues noted IVIG is no more effective than heparin and low-dose aspirin in the treatment of pregnancies complicated by antiphospholipid syndrome but has not been adequately evaluated in refractory cases. Finally, pending convincing studies, IVIG is not effective and should not be used for the management of recurrent miscarriage. Either low-dose aspirin or heparin therapy is appropriate in this clinical setting. Ata and colleagues evaluated six randomized controlled trials including 272 women. They determined a beneficial effect of IVIG in treatment of recurrent miscarriage was not observed. Given the absence of a proven mechanism of action, and the lack of a diagnostic algorithm to identify patients who are likely to benefit from such treatment, IVIG administration for treatment of recurrent miscarriage is not justified outside the context of properly designed randomized clinical trials. Therefore, Gammagard liquid 10% vial is not likely to be more efficacious than other available treatment options. Based upon the information set forth above, the requested medication 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.
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A 47-year-old female enrollee has requested authorization and coverage for a sleep study. The Health Insurer has denied this request indicating that the requested services are not medically necessary for evaluation of the enrollees medical condition.
In this patients case, she has a very high risk of obstructive sleep apnea because of obesity, witnessed apnea and elevated Epworth Sleepiness Scale score. The records document awakening gasping and snoring. Since she has a | Overturned | Medical Necessity | Summary Reviewer
A 47-year-old female enrollee has requested authorization and coverage for a sleep study. The Health Insurer has denied this request indicating that the requested services are not medically necessary for evaluation of the enrollees medical condition. The physician reviewer found there is sufficient support for the requested services in this patients case. Diagnostic sleep studies are indicated for patients with an increased risk of obstructive sleep apnea. In this patients case, she has a very high risk of obstructive sleep apnea because of obesity, witnessed apnea and elevated Epworth Sleepiness Scale score. The records document awakening gasping and snoring. Since she has a high risk of sleep apnea, the requested sleep study is appropriate. The current medical evidence supports the requested services in this clinical setting. All told, the requested sleep study is medically indicated for the treatment of this patient. Therefore, 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 53-year-old female enrollee has requested reimbursement for the homocysteine testing performed on 3/9/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees peripheral neuropathy.
this patient presented with a focal peripheral nerve symptom in the distribution of the right superficial peroneal nerve with no sensory findings on exam, normal EMG, and mild changes on MRI. | Upheld | Experimental | Summary Reviewer 1
A 53-year-old female enrollee has requested reimbursement for the homocysteine testing performed on 3/9/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees peripheral neuropathy. The physician reviewer found that this patient presented with a focal peripheral nerve symptom in the distribution of the right superficial peroneal nerve with no sensory findings on exam, normal EMG, and mild changes on MRI. Overall, the patients history and findings do not support a diagnosis of peripheral neuropathy, and the laboratory testing performed would not be expected to show any related abnormalities. Homocysteine levels are checked when a patients B12 and/or methylmalonic acid levels are equivocal. However, routine use of methylmalonic acid and homocysteine is not considered the standard of care for the work-up of peripheral neuropathy, as methylmalonic acid is the usual confirmatory test and homocysteine is generally not helpful. As B12 deficiency can be diagnosed with standard testing with use of B12 and methylmalonic acid, and homocysteine is obtained if initial testing is equivocal, the homocysteine testing performed on 3/9/16 was not more likely to lead to a proper diagnosis over standard testing. 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 53-year-old male enrollee has requested authorization and coverage for proton beam radiation therapy. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees prostate cancer. | Upheld | Medical Necessity | Summary Reviewer
A 53-year-old male enrollee has requested authorization and coverage for proton beam radiation therapy. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees prostate cancer. The physician reviewer found that according to the National Comprehensive Cancer Network (NCCN) guidelines, proton beam radiation therapy has not been demonstrated to provide superior health outcomes when compared to standard available radiation therapy for management of prostate cancer. In addition, proton beam radiation therapy is currently the subject of ongoing clinical trials. Overall, there is insufficient high quality clinical evidence to make conclusions about the relative safety and efficacy of proton beam radiation as compared with standard of care photon intensity modulated radiation therapy (IMRT). All told, the requested proton beam radiation therapy is not medically necessary for treatment of this patients prostate cancer. Based on the foregoing discussion, the requested services are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
A 29-year-old female enrollee has requested reimbursement for Anser IFX testing performed on 2/25/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease. | Upheld | Experimental | Summary Reviewer 1
A 29-year-old female enrollee has requested reimbursement for Anser IFX testing performed on 2/25/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found that the submitted documentation fails to demonstrate the superior efficacy of the services at issue. There is insufficient evidence to support the use of drug level monitoring for biologics in this clinical setting. The quality of evidence is considered to be low due to the fact that studies to date have primarily been retrospective. High-quality, randomized controlled trials are lacking. The evidence to date does not demonstrate that this strategy leads to better clinical outcomes. Therefore, Anser IFX testing performed on 2/25/16 was not 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 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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The parent of a 14-year-old female enrollee has requested reimbursement for mental health treatment provided from 7/28/16 through 8/10/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions.
During the dates of service in dispute, the patient was still requiring up to several hours of one-on-one staff time in order to perform routine activities of daily living. She continued to need prompts for getting up in the morning, going to bed and completing showering and washing her face and hair in
needed treatment in getting out of bed, preparing to shower and other morning hygiene routines. This patient required staff to be in the bathroom with her, which would not have occurred in a less intensive level of care. | Overturned | Medical Necessity | Summary Reviewer
The parent of a 14-year-old female enrollee has requested reimbursement for mental health treatment provided from 7/28/16 through 8/10/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found the submitted documentation supports the medical necessity of the services at issue. During the dates of service in dispute, the patient was still requiring up to several hours of one-on-one staff time in order to perform routine activities of daily living. She continued to need prompts for getting up in the morning, going to bed and completing showering and washing her face and hair in an acceptable amount of time. The amount of staff time she required would not be provided at the partial hospitalization program level of care. More importantly, she needed treatment in getting out of bed, preparing to shower and other morning hygiene routines. This patient required staff to be in the bathroom with her, which would not have occurred in a less intensive level of care. This symptom also had to be addressed, as it was the symptom causing the greatest degree of functional impairment in her life. All told, for mental health treatment provided from 7/28/16 through 8/10/16 were indicated for the treatment of this patient. Therefore, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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A 33-year-old female enrollee has requested reimbursement for methylenetetrahydrofolate reductase (MTHFR) test and Factor V Leiden performed on 5/17/18. 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 deep vein thrombosis and pulmonary embolism. | Overturned | Experimental | Summary Reviewer 1
A 33-year-old female enrollee has requested reimbursement for methylenetetrahydrofolate reductase (MTHFR) test and Factor V Leiden performed on 5/17/18. 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 deep vein thrombosis and pulmonary embolism. The physician reviewer found that a prior personal history of deep vein thrombosis/pulmonary embolism, especially in the setting of oral contraceptive use or pregnancy, is a significant risk factor for thrombosis during pregnancy. Since no records were available regarding prior laboratory work-up for inherited thrombophilias, Factor V Leiden testing was medically appropriate. However, the medical evidence does not support MTHFR testing in this setting since MTHFR mutations have not been associated with venous thromboembolism either in pregnant or non-pregnant patients. Therefore, Factor V Leiden testing performed on 5/17/18 was likely to have been of greater benefit than other methods of evaluating this patient. However, the superior efficacy of MTHFR has not been established. Based upon the information set forth above, a portion of the services 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 partially overturned.
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A 32-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 9/24/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. | Upheld | Experimental | Summary Reviewer 1
A 32-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 9/24/19. 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 there is a lack of support for the services at issue in this clinical setting. Prognostic gene expression profiling (GEP) testing to differentiate melanomas at low versus high risk for metastasis should not replace pathologic staging procedures. Moreover, since there is a low probability of metastasis in stage I melanoma and a higher proportion of false-positive result, GEP testing should not guide clinical decision making in this group. This patient has a small good prognosis lesion based on pathology. Commercially available GEPs, such as DecisionDx-Melanoma testing, are marketed as being able to classify cutaneous melanoma into separate categories used on risk of metastasis. However, it remains unclear where these GEP platforms provide clinically actionable prognostic information when used in addition to or in comparison with known cliniopathologic factors or multivariate nomograms that incorporate patient sex, age, tumor location and thickness, ulceration, mitotic rate, lymphovascular invasion, and sentinel lymph node biopsy status. Furthermore, the impact of these tests on treatment outcomes or follow-up schedules has not been established. Various (mostly retrospective) studies of prognostic GEP testing suggest its role as an independent predictor of worse outcome, although not superior to Breslow thickness or sentinel lymph node status. It remains unclear whether this GEP profile is reliably predictive of outcome across the risk spectrum of melanoma. Prospective validation studies are required to more accurately define the clinical utility of molecular testing prior to widespread implementation of GEP for prognostication of cutaneous melanoma, and in particular to determine its role in guiding surveillance imaging, sentinel lymph node biopsy, and adjuvant treatment decisions. Therefore, DecisionDx-Melanoma testing performed on 9/24/19 was not likely to have been more beneficial than other available standard therapy.
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A 63-year-old female enrollee has requested authorization and coverage for an iris prosthesis. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. | Overturned | Experimental | Summary Reviewer 1
A 63-year-old female enrollee has requested authorization and coverage for an iris prosthesis. 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 traumatic aniridia can lead to photophobia and disfigurement, both of which need to be addressed. The main options are contact lens or an iris prosthesis. In this case, the patient has already tried contact lens. There is sufficient support for the use of an iris prosthesis in this setting, and these services have been approved by the U.S. Food and Drug Administration (FDA). In this patientas case, an iris prosthesis is likely to be more beneficial than contact lens. A contact lens does not fully restore cosmesis and carries a risk of infection. Therefore, the requested iris prosthesis is likely to be more beneficial for the treatment of this patient than any available standard therapy.
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A 48-year-old female enrollee has requested reimbursement for the lab testing provided on 11/28/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees migraines, mild memory impairment, and prior syncope.
that this patient presented with a common problem that is migraine with aura. | Upheld | Experimental | Summary Reviewer 2
A 48-year-old female enrollee has requested reimbursement for the lab testing provided on 11/28/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees migraines, mild memory impairment, and prior syncope. The physician reviewer found that this patient presented with a common problem that is migraine with aura. An extensive and expensive battery of testing for thrombophilia was ordered based on the providers concern about vascular risk factors. However, there is no mention of standard testing for vascular risk factors such as cholesterol levels, nor is there standard coagulation testing that might indicate an abnormal potential for thrombophilia. There is also no history of any coagulation issues in the past such as recurrent miscarriage, deep vein thrombosis, stroke, or myocardial infarction. As noted in the peer-reviewed medical literature, there is currently no role for the thrombophilia testing ordered by the provider in this clinical setting. Specifically, routine screening of homocysteine, Leiden V, and methylenetetrahydrofolate reductase (MTHFR) is not recommended due to positive testing in the asymptomatic general population. Many publications have guidelines for use of these tests, however this patient has none of the indications for thrombophilia testing. Thus, the lab testing provided on 11/28/16 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 64-year-old female enrollee has requested reimbursement for ChemoFx Assay testing performed on 9/30/13. The Health Insurer has denied this request indicating that the testing at issue was not medically necessary for evaluation of the enrollees ovarian cancer.T | Upheld | Medical Necessity | Summary Reviewer
A 64-year-old female enrollee has requested reimbursement for ChemoFx Assay testing performed on 9/30/13. The Health Insurer has denied this request indicating that the testing at issue was not medically necessary for evaluation of the enrollees ovarian cancer.The physician reviewer found that review of the submitted documentation fails to establish the medical necessity of the testing at issue. In vitro drug testing on patients tumor cells prior to applying chemotherapy is an attractive idea but it is difficult to put into clinical use. The most thorough evaluation of these technologies was performed by the American Society of Clinical Oncology. In their review of this technology the panel concluded that in vitro drug testing should be limited to clinical trials (Schrag, et al). Moreover, the Physicians Data Query of the National Cancer Institute does not specifically recommend the ChemoFx Assay to direct therapy. In the clinical setting of newly diagnosed ovarian cancer there is extensive clinical data supporting the first-line use of paclitaxel and carboplatin. For the reasons provided, ChemoFx Assay testing performed on 9/30/13 was not medically necessary for evaluation of this patients medical condition. Therefore, the Health Insurers denial should be upheld.
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A 48-year-old male enrollee has requested authorization and coverage for cervical artificial discectomy and second level cervical discectomy. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.
, the patient has ill- defined neck pain and upper extremity symptoms. | Upheld | Experimental | Summary Reviewer 1
A 48-year-old male enrollee has requested authorization and coverage for cervical artificial discectomy and second level cervical discectomy. 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 the requested services are not likely to be more effective for this patient than other available options. Based on the documentation submitted for review, the patient has ill- defined neck pain and upper extremity symptoms. There is a lack of evidence demonstrating cervical radiculopathy (Bono) with dermatomal and myotomal symptoms and findings matching that diagnosis with correlation of radiographic findings. In addition, his pain generator has not been defined. There is a lack of conclusive evidence, including physical findings to implicate the C5-6 or the C6-7 level as the patients source of pain. Although the study by Davis and colleagues is encouraging, there is a lack of support in the peer-reviewed literature demonstrating the long term safety and effectiveness of Mobi-C. All told, the requested surgery is not 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.
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A 44-year-old female enrollee has requested authorization and coverage for the Intracept procedure. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. | Overturned | Experimental | Summary Reviewer 2
A 44-year-old female enrollee has requested authorization and coverage for the Intracept procedure. 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 there is sufficient support for the requested services in this clinical setting. Khalil and colleagues performed a prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain. The authors concluded that minimally invasive radiofrequency ablation of the basivertebral nerve led to significant improvement of pain and function at three months in patients with chronic vertebrogenic related low back pain. Fischgrund and colleagues concluded that patients treated with radiofrequency ablation of the basivertebral nerve for chronic low back pain exhibited sustained clinical benefits in the Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) pain scores, and maintained high responder rates at two years following treatment. Basivertebral nerve ablation appears to be a durable, minimally invasive treatment for the relief of chronic low back pain. She has failed to respond to nonsurgical management. Therefore, the requested Intracept procedure is likely to be more beneficial than any available standard therapy.
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The patient is a 42-year-old female with a history of chronic low back pain. The progress notes dated 10/7/17, document a six month history with pain in the lower back radiating into both lower extremities. Associated symptoms included numbness, tingling and loss of bladder/bowel control. The pain was reported to be 8 out of 10 and worsening. The patient reported that any level of movement aggravated her low back pain. Medications for pain relief were not effective.
al, and exercise program. On examination, transfers were difficult; range of motion was limited and magnetic resonance imaging (MRI) scan revealed degenerative disc disease at L5-S1 with a 2 mm bulge and possible annular tear on the right. The follow up progress notes document continuing worsening of pain, primarily in the lower back on the right side consistent with the MRI findings of the right side involvement. The provider discussed treatment options and the patient elected the surgical option in light of the degree of disability. The provider is recommending anterior lumbar interbody fusion at L5-S1 with anterior instrumentation, L5-S1 cage with interbody fusion with harvest of iliac crest autograft versus bone morphogenic protein. The patient has requested authorization and coverage for autograft spine surgery. The Health Insurer denied this request and reported that the requested services are not medically not necessary. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 42-year-old female with a history of chronic low back pain. The progress notes dated 10/7/17, document a six month history with pain in the lower back radiating into both lower extremities. Associated symptoms included numbness, tingling and loss of bladder/bowel control. The pain was reported to be 8 out of 10 and worsening. The patient reported that any level of movement aggravated her low back pain. Medications for pain relief were not effective. Other conservative treatments, which have been tried and failed, include chiropractic, physical therapy, topical, and exercise program. On examination, transfers were difficult; range of motion was limited and magnetic resonance imaging (MRI) scan revealed degenerative disc disease at L5-S1 with a 2 mm bulge and possible annular tear on the right. The follow up progress notes document continuing worsening of pain, primarily in the lower back on the right side consistent with the MRI findings of the right side involvement. The provider discussed treatment options and the patient elected the surgical option in light of the degree of disability. The provider is recommending anterior lumbar interbody fusion at L5-S1 with anterior instrumentation, L5-S1 cage with interbody fusion with harvest of iliac crest autograft versus bone morphogenic protein. The patient has requested authorization and coverage for autograft spine surgery. The Health Insurer denied this request and reported that the requested services are not medically not necessary. This denial is the subject of this appeal and determination. There is support in the medical literature for the medical necessity of the requested services in this clinical setting. Anterior lumbar interbody fusion is associated with higher success rates compared with posterolateral lumbar fusion in patients with degenerative changes of the lumbar spine including those with instability. There is moderate evidence that for patients with lumbar degenerative disc disease without instability a standalone anterior lumbar interbody fusion has better clinical outcomes than the anterior lumbar interbody fusion plus instrumented open posterior lumbar fusion. With regard to the type of interbody spacer used, the proposed autograft has a high fusion rate. In this case, the patient has severe pain that has not responded to conservative treatment. The patients pain is interfering with her activities of daily living. The provider has documented discogenic origin for the pain. Based on medical literature and guidelines, the requested anterior lumbar interbody fusion procedure is medically necessary for treatment of this patients medical condition. Therefore, for the reasons stated above, 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 31-year-old male enrollee has requested reimbursement for respiratory sleep studies performed on 6/8/14, 6/17/14 and 6/19/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees sleep apnea.
In addition, his Epworth Sleepiness score was normal at 4. There was no reported morning headache. The patient reported snoring and was slightly overweight. | Upheld | Medical Necessity | Summary Reviewer
A 31-year-old male enrollee has requested reimbursement for respiratory sleep studies performed on 6/8/14, 6/17/14 and 6/19/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees sleep apnea. The physician reviewer found the review of the submitted documentation and relevant literature fails to demonstrate the medical necessity of the services at issue. There was no documentation of hypersomnia. Hypersomnia is the cornerstone for a diagnosis of clinically significant sleep apnea. In addition, his Epworth Sleepiness score was normal at 4. There was no reported morning headache. The patient reported snoring and was slightly overweight. However, this is not an indication for a sleep study. Based on the medical records submitted and the peer-reviewed literature, the respiratory sleep studies performed on 6/8/14, 6/17/14 and 6/19/14 were 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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A 63-year-old male enrollee has requested authorization and coverage for laparoscopy, surgical, esophagogastric fundoplasty (LINX). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.
. The patient has a diagnosis of persistent chronic GERD that has persisted despite treatment with proton pump inhibitor dosing and behavioral modification. The patient has a DeMeester score of 35 with evidence of Barretts per esophagogastroduodenoscopy (EGD). | Upheld | Experimental | Summary Reviewer 1
A 63-year-old male enrollee has requested authorization and coverage for laparoscopy, surgical, esophagogastric fundoplasty (LINX). 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 LINX Reflux Management System (LINX) is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The patient has a diagnosis of persistent chronic GERD that has persisted despite treatment with proton pump inhibitor dosing and behavioral modification. The patient has a DeMeester score of 35 with evidence of Barretts per esophagogastroduodenoscopy (EGD). Treatment with the LINX procedure is indicated due to his persistent acid reflux and resulting in damage that will likely predispose him to adenocarcinoma. For the reasons provided above, the requested services are likely to be more beneficial for treatment of the patients medical condition than other modalities.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.
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A 56-year-old male enrollee has requested reimbursement for positron emission tomography (PET) scan performed on 1/19/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
The records indicate that the patient has metastatic prostate cancer. | Overturned | Experimental | Summary Reviewer 2
A 56-year-old male enrollee has requested reimbursement for positron emission tomography (PET) scan performed on 1/19/16. 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 patients case. The records indicate that the patient has metastatic prostate cancer. The PET scan performed on 1/19/16 was likely to have been more efficacious than other methods of evaluation. The medical literature supports this modality as superior to bone scan with regards to detection of prostate cancer bone metastases within the spine. The PET scan performed is the most reliable investigational tool when there is high index of suspicion for osseous metastases. 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 22-year-old male enrollee has requested reimbursement for (81229) cytogenomic constitutional (genome-wide) microarray analysis; interrogation of genomic regions for copy number and single nucleotide polymorphism (SNP) variants for chromosomal abnormalities on 3/16/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees behavioral health condition. | Upheld | Experimental | Summary Reviewer 2
A 22-year-old male enrollee has requested reimbursement for (81229) cytogenomic constitutional (genome-wide) microarray analysis; interrogation of genomic regions for copy number and single nucleotide polymorphism (SNP) variants for chromosomal abnormalities on 3/16/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees behavioral health condition. The physician reviewer found that there is a lack of evidence based literature that show the efficacy of genetic testing in evaluating patients diagnosed with bipolar disorders or ADHD. There is very limited clinical justification, based on substantial medical research, to endorse genetic screening tests prior to attempting another medication for treatment of ADHD, bipolar disorder, or personality disorders. Specifically, the standard of care for treatment of these disorders would be to continue to trial or prescribe stimulant medication. This method of prescribing medication would produce similar outcomes when compared to awaiting genetic testing results in this patients case. In sum, cytogenomic constitutional (genome-wide) microarray analysis; interrogation of genomic regions for copy number and SNP variants for chromosomal abnormalities administered on 3/16/16 were not likely to have been more effective than the standard options available for the evaluation of this patient. 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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The parent of a 13-year-old male enrollee has requested reimbursement for balloon sinus ostial dilation performed on 10/28/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees chronic sinus problems.
. The records noted that the patient had evidence of PANDAS. This problem was ultimately treated with removal of tonsils and adenoids in July 2015. The patient apparently had some evidence of nasal and sinus congestion and difficulty breathing through the nose, but
Preoperative computed tomography (CT) scan demonstrated that the maxillary, ethmoid and frontal sinuses showed some degree of mild mucus congestion, but | Overturned | Experimental | Summary Reviewer 3
The parent of a 13-year-old male enrollee has requested reimbursement for balloon sinus ostial dilation performed on 10/28/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees chronic sinus problems. The physician reviewer found there is a lack of support for the services at issue in this patients case. The records noted that the patient had evidence of PANDAS. This problem was ultimately treated with removal of tonsils and adenoids in July 2015. The patient apparently had some evidence of nasal and sinus congestion and difficulty breathing through the nose, but there is no mention of adequate medical management of the sinus congestion prior to consideration of any surgical intervention such as inferior turbinate ablation and balloon sinus dilation technology. Preoperative computed tomography (CT) scan demonstrated that the maxillary, ethmoid and frontal sinuses showed some degree of mild mucus congestion, but there was no evidence of any severe thickening or obstruction of the drainage pathways of the paranasal sinuses. At present, functional endoscopic sinus surgical techniques for the management of chronic rhinosinusitis refractory to medical management is still considered the surgical treatment of choice. Thus, balloon sinus ostial dilation performed on 10/28/15 was not likely to have been of greater benefit than other treatment alternatives. 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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The parent of a seven-year-old male enrollee has requested reimbursement and prospective authorization and coverage for 40 hours per week of direct applied behavioral analysis (ABA) therapy, eight hours per month of supervision and six hours for the contract period for re-assessment provided from 11/9/16 through 5/9/17. 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 medical condition. | Overturned | Medical Necessity | Summary Reviewer
The parent of a seven-year-old male enrollee has requested reimbursement and prospective authorization and coverage for 40 hours per week of direct applied behavioral analysis (ABA) therapy, eight hours per month of supervision and six hours for the contract period for re-assessment provided from 11/9/16 through 5/9/17. 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 medical condition. The physician reviewer found the correlation between treatment outcomes and treatment intensity is well documented. Ample research has shown that intensive applied behavior analysis (ABA) treatment produces robust outcomes for individuals with autism spectrum disorder (ASD). (Linstead, et al). Linstead and colleagues studied 726 children (ages 1.5 to 12) to evaluate the relationship between treatment intensity and treatment outcomes. The study showed a strong relationship between treatment intensity and mastery of learning objectives, where higher treatment intensity predicted greater progress. 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 continues to demonstrate significant delays that place him at an increased risk for injury, and also makes it difficult for him to be successful in more generalized environments. Based on the documentation submitted for review, the request for 40 hours per week of direct ABA therapy, eight hours per month of supervision and six hours for the contract period for re-assessment provided from 11/9/16 through 5/9/17 were and are medically necessary for treatment of the patients medical condition. Therefore, the services at issue were and are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned. | 0 |
A 26-year-old female enrollee has requested reimbursement for laboratory services (CPT code 83993) performed on 10/5/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees structuring ileocolic Crohns disease. | Overturned | Experimental | Summary Reviewer 3
A 26-year-old female enrollee has requested reimbursement for laboratory services (CPT code 83993) performed on 10/5/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees structuring ileocolic Crohns disease. The physician reviewer found that persistent disease activity is associated with a poor prognosis in inflammatory bowel disease (IBD). Therefore, monitoring of patients in this clinical setting with intent to suppress subclinical inflammation has emerged as a reasonable community standard treatment goal. As endoscopic monitoring is invasive and resource intensive, identification of valid markers of disease activity has been a priority. Calprotectin, when measured in feces, is now used in clinical practice to differentiate between non-organic and inflammatory intestinal disorders, especially to identify IBD. Fecal calprotectin may also be useful, as has been proposed for this patient, to monitor patients with IBD under treatment and to predict the risk of recurrence of active disease prior to clinical relapse (Burri and Beglinger). Given this support, the laboratory services (CPT code 83993) performed on 10/5/17 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.
| 0 |
A 29-year-old female enrollee has requested reimbursement for chiropractic care provided from 1/30/19 through 6/28/19 and physical therapy provided from 5/06/19 through 6/06/19. 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 patient underwent physical therapy and chiropractic care after her motor vehicle accident in November 2018. She had persistent symptoms despite the physical therapy and chiropractic services that were rendered. She did not have any impairment that would
her from performing an independent exercise and palliative modality program after a short series of visits to physical therapy following the motor vehicle accident. | Upheld | Medical Necessity | Summary Reviewer
A 29-year-old female enrollee has requested reimbursement for chiropractic care provided from 1/30/19 through 6/28/19 and physical therapy provided from 5/06/19 through 6/06/19. 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 in this case, the patient underwent physical therapy and chiropractic care after her motor vehicle accident in November 2018. She had persistent symptoms despite the physical therapy and chiropractic services that were rendered. She did not have any impairment that would have precluded her from performing an independent exercise and palliative modality program after a short series of visits to physical therapy following the motor vehicle accident. There was no indication of objective benefit of ongoing chiropractic therapy. While the patient may have had ongoing symptoms, her symptoms would not have been expected to marginally improve with the interventions in question over an independent program. In fact, despite the interventions that were rendered, no significant objective benefit that can be reasonably attributed to the services in question is documented. Therefore, chiropractic care provided from 1/30/19 through 6/28/19 and physical therapy provided from 5/06/19 through 6/06/19 were not medically necessary for the treatment of this patient. | 1 |
The patient is a 64-year-old female with severe obstructive sleep apnea. The medical records document a history of unsuccessful attempts to utilize the gold standard treatment of continuous positive airway pressure (CPAP) therapy. On 9/12/17, the records noted a body mass index of 20.2. On 9/26/17, septoplasty and bilateral inferior turbinate reduction was performed. On 10/12/17, a home sleep study confirmed that the patient had a total of 162 obstructive apnea episodes, without central apnea. The documentation noted an apnea-hypopnea index of 43.0 episodes per hour of sleep. The patient has requested coverage for an implanted nerve stimulator. The Health Insurer has denied this request and reported that the requested device is investigational for the treatment of this patient. There
. The patient had trialed CPAP therapy for airway management and was intolerant to the use of this device. | Overturned | Experimental | Summary Reviewer 2
The patient is a 64-year-old female with severe obstructive sleep apnea. The medical records document a history of unsuccessful attempts to utilize the gold standard treatment of continuous positive airway pressure (CPAP) therapy. On 9/12/17, the records noted a body mass index of 20.2. On 9/26/17, septoplasty and bilateral inferior turbinate reduction was performed. On 10/12/17, a home sleep study confirmed that the patient had a total of 162 obstructive apnea episodes, without central apnea. The documentation noted an apnea-hypopnea index of 43.0 episodes per hour of sleep. The patient has requested coverage for an implanted nerve stimulator. The Health Insurer has denied this request and reported that the requested device is investigational for the treatment of this patient. There is sufficient support for the requested device in this clinical setting. This patient meets clinical criteria for consideration of surgical management of her obstructive sleep apnea symptoms. Prior evaluation has documented the degree of obstructive sleep apnea to be severe. The patient had trialed CPAP therapy for airway management and was intolerant to the use of this device. Clinical studies indicate that patients only benefit from this device when they have a body mass index less than 32, and the patient meets this criteria. Per the medical evidence, patients achieve a definite benefit from the implantation and electrical stimulation of the hypoglossal nerve for treatment of this disorder. All told, the requested implanted nerve stimulator is likely to be superior over other available treatment options. 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 |
The patient is a 37-year-old female with a history of mood and psychotic disorder and borderline personality disorder. The patient was admitted to a residential treatment center (RTC) three weeks after she reportedly overdosed on Ativan. She was admitted to the RTC on 12/29/15. The patient was treated with psychotherapy, milieu therapy, and psychopharmacology with Geodon and lithium. The patient has requested reimbursement for RTC services provided from 1/15/16 through 2/11/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 37-year-old female with a history of mood and psychotic disorder and borderline personality disorder. The patient was admitted to a residential treatment center (RTC) three weeks after she reportedly overdosed on Ativan. She was admitted to the RTC on 12/29/15. The patient was treated with psychotherapy, milieu therapy, and psychopharmacology with Geodon and lithium. The patient has requested reimbursement for RTC services provided from 1/15/16 through 2/11/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary. Based on the Level of Care Utilization System (LOCUS) criteria, an accepted, national standard for determining the appropriate level of care for adults, the patient demonstrated moderate risk of harm (score 3) given a suicide attempt three weeks prior to her admission at the RTC. However, the patient had some improvement in the RTC and did not have any suicidal or homicidal ideation by 1/15/16. The patient had moderate functional impairment (score 3) with a serious deterioration in her ability to fulfill her responsibilities. She has ongoing severe interpersonal deficits. The patient has made progress while she has been in the RTC. Documentation by 1/15/16 states that the patient had improved insight, was more self-aware, was more engaged, and her psychotic symptoms were resolving. The patient had significant co-morbidity (score 3) with a mood and psychotic disorder as well as borderline personality disorder. The patients recovery environment was moderately stressful (score 3) as she broke up with her boyfriend four months prior to entering the RTC and this was seen as a major transition for the patient. The patient had limited support from others (score 3) and she demonstrated equivocal response to treatment and recovery (score 3) as she had been treated in an outpatient settings prior to her admission. The patient demonstrated limited engagement and recovery (score 3) as she was attentive and engaged during treatment. However, the patient was guarded and would not share her entire inner-experience. Documentation states that the patient showed more self-awareness and has been more engaged in groups. This gives the patient a composite score of 21, which is consistent with partial hospitalization program (PHP). The patient required treatment for her mood and psychotic disorder and borderline personality disorder, but this could have been done at a PHP level of care. Therefore, the RTC services provided from 1/15/16 through 2/11/16 was not medically necessary for treatment of this patients behavioral health issues. Based on the foregoing discussion, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 40-year-old female enrollee has requested reimbursement for homocysteine testing and polymerase chain reaction testing for EBV performed on 8/08/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 1
A 40-year-old female enrollee has requested reimbursement for homocysteine testing and polymerase chain reaction testing for EBV performed on 8/08/18. 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 evaluation for vitamin B12 deficiency includes an examination for gastrointestinal, dermatologic, neurologic, and other findings, and laboratory testing, including a complete blood count and vitamin B12 levels. Additional testing with methylmalonic acid (MMA) or homocysteine levels may be appropriate if the vitamin B12 level is borderline low or discordant with the clinical picture. In this case, do not support the need for homocysteine testing. Therefore, homocysteine testing and polymerase chain reaction testing for Epstein Barr virus performed on 8/08/18 were not likely to have been superior over other methods of evaluating this patient.
| 0 |
A 68-year-old female enrollee has requested reimbursement for human epididymis protein 4 (HE4) testing performed on 9/20/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 3
A 68-year-old female enrollee has requested reimbursement for human epididymis protein 4 (HE4) testing performed on 9/20/18. 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 for patients with localized endometrial cancer, if the patient has elevated CA-125 at the time of initial diagnosis, then current National Comprehensive Cancer Network guidelines recommend serial testing of serum CA-125 for recurrence monitoring. Multiple other serum proteins expressed by endometrial cancer are currently being investigated as possible markers for recurrent disease, including human epididymis protein 4 (HE4). Secreted HE4 has been extensively studied as a serum biomarker for proposed uses for either screening, detection of recurrence or monitoring of therapeutic response for ovarian cancer. Secreted HE4 is also associated with endometrial cancer, and continues to be studied as a potential biomarker for differentiating between malignant and benign pelvic masses, screening for malignancy, prognosis, recurrence detection, and therapeutic response. However, it is not currently accepted as a standard of care for patients with endometrial cancer. The study by Abbink and colleagues compared HE4 to the standard of care marker CA-125. Although the authors indicated the possibility of superior performance of HE4 compared to CA-125 for detection of recurrence in patients with endometrial cancer, they also noted that a future prospective study on a larger cohort of patients with endometrial cancer is needed to affirm the preoperative value of serum HE4 and the use of HE4 in routine follow-up. At this time, the superior efficacy of the services at issue has not been established. Thus, HE4 testing performed on 9/20/18 was not likely to have been more effective than other methods of evaluating this patient.
| 0 |
A 50-year-old male has requested authorization and coverage for code 43210 and one inpatient bed day. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 3
A 50-year-old male has requested authorization and coverage for code 43210 and one inpatient bed day. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the efficacy of transoral incisionless fundoplication (TIF) using the EsophyX device has been studied in randomized controlled trials. However, the conclusions are contradictory. The large randomized trial by Witteman and colleagues included 60 patients. The authors found no improvement in esophageal acid exposure compared with baseline at 12 months. Normalization of pH was accomplished in only 29% in conjunction with deteriorated valve appearances at endoscopy and resumption of proton pump inhibitors in 61%. The study concluded that no long-term objective reflux control was achieved. A recent meta-analysis by McCarty and colleagues noted that further safety and efficacy comparison is needed with conventional treatment, such as Nissen fundoplication. There have been reports of severe adverse events during the procedure and the need for surgery to revise ineffective TIF. Thus, code 43210 and one inpatient bed day are not likely to be more beneficial than other available treatment options.
| 0 |
A 43-year-old female enrollee has requested reimbursement for molecular pathology testing provided on 4/14/16. The Health Plan has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees breast cancer. | Overturned | Experimental | Summary Reviewer 3
A 43-year-old female enrollee has requested reimbursement for molecular pathology testing provided on 4/14/16. The Health Plan has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees breast cancer. The physician reviewer found the molecular pathology testing provided on 4/14/16 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. BRCA1 mutation can increase risk for breast, ovarian, cervical, uterine, pancreatic, gastric, and prostate cancers (Brose, et al; Thompson and Easton). BRCA2 mutations can increase risk for breast, ovarian, gall bladder, bile duct, prostate, pancreatic, and gastric cancers (Liede, et al; Tai, et al; Ferrone, et al). In the event the BRCA tests were negative, there is still a possibility of hereditary predisposition from another gene defect. The Amsterdam criteria and the Bethesda consensus guidelines evaluate the occurrence of Lynch syndrome or hereditary nonpolyposis colorectal cancer (HNPCC) tumors in families. Notably, the Amsterdam criteria have low sensitivity in HNPCC detection so the Bethesda guidelines were developed (Umar, et al). However, these guidelines are highly focused on patients with colorectal cancer who have microsatellite instability although the occurrence of microsatellite instability in other Lynch syndrome associated tumors was discussed. The most common extracolonic tumors in Lynch syndrome are endometrial, ovarian, gastric, renal, small intestine, pancreas, hepatobiliary, and ureteral cancers. This patients family history is suggestive of a breast/ovarian cancer syndrome. The MyRisk panel is appropriate since the current clinical situation may be caused by several potential cancer-causing genes. Therefore, the testing at issue 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.
| 1 |
The patient is a 29-year-old female who presented to her provider for prenatal care at a gestational age of 22 weeks. At 18 to 20 weeks gestation, a screening anatomy scan was performed and a thickened nuchal fold was noted. This was again confirmed on a follow up ultrasound and a subsequent recommendation for chromosomal testing was offered. The provider discussed the option of amniocentesis or cell free DNA screening. The patient had opted for cell free DNA screening. The patient has requested reimbursement for fetal chromosomal aneuploidy genomic sequence performed on 9/18/17. The Health Insurer denied reimbursement and reported that the services at issue were not medically necessary for the evaluation of this patients medical condition.
due to a thickened nuchal fold that was noted by a screening anatomy scan at 18 to 20 weeks gestation and again confirmed | Overturned | Medical Necessity | Summary Reviewer
The patient is a 29-year-old female who presented to her provider for prenatal care at a gestational age of 22 weeks. At 18 to 20 weeks gestation, a screening anatomy scan was performed and a thickened nuchal fold was noted. This was again confirmed on a follow up ultrasound and a subsequent recommendation for chromosomal testing was offered. The provider discussed the option of amniocentesis or cell free DNA screening. The patient had opted for cell free DNA screening. The patient has requested reimbursement for fetal chromosomal aneuploidy genomic sequence performed on 9/18/17. The Health Insurer denied reimbursement and reported that the services at issue were not medically necessary for the evaluation of this patients medical condition. There is support for the medical necessity of the services at issue in this clinical setting. The American College of Obstetrics and Gynecology (ACOG) in conjunction with the Society for Maternal Fetal Medicine addressed the issue of the use of cell free DNA testing. The Committee Opinion recognized patient option to choose noninvasive prenatal testing as a strategy to screen for aneuploidy regardless of the patients risk status but does so with the caveat that she understands the limitations and benefits of this screening paradigm in the context of alternate screening and diagnostic options. Essentially, ACOG Committee has defined testing as it relates to low risk and high risk patients. In this case, the patient met the criteria for high risk setting due to a thickened nuchal fold that was noted by a screening anatomy scan at 18 to 20 weeks gestation and again confirmed on a follow up ultrasound. This finding, although isolated, is associated with an increased risk of aneuploidy specifically Trisomy 21. Nuchal edema or fold which is measured at more than 6 mm is found in about 0.1 to 0.5% of fetuses. It may be of no pathological significance; however, these findings may be associated with chromosomal defects, cardiac anomalies, infection or genetic syndromes. The measurement is considered abnormal if it is 6 mm or greater. In this case, the patients nuchal edema or fold was 6.4 and was elevated for all gestational ages between 15 to 24 weeks. Using a threshold of 6 mm, or greater, as an abnormal measurement, 40% of the fetuses with trisomy 21 were identified with a thickened nuchal fold. A thickened nuchal fold is also associated with euploid syndromes, such as the Noonan syndrome, as well as with heart defects. In sum, the fetal chromosomal aneuploidy genomic sequence performed on 9/18/17 was medically necessary for the evaluation of this patient.Therefore, for the reasons stated above, the services at issue were medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
patient is a 40-year-old female who presented with an abnormal mammogram. The patient
has requested authorization and coverage for proton beam radiation therapy. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 40-year-old female who presented with an abnormal mammogram. The patient
has requested authorization and coverage for proton beam radiation therapy. The physician
reviewer found that guidelines do not endorse the routine use of proton beam radiation therapy
in the treatment of breast cancer. There is a lack of data to suggest that proton beam radiation
therapy would be beneficial in this case or that it would be associated with less side effects than
standard treatment with three-dimensional conformal or standard intensity modulated
techniques which are typically given with partial breast radiation. Furthermore, consensus group
guidelines do not support the use of proton beam radiation therapy in this setting. Typically,
photon treatments using deep inspiratory breath hold which moves the heart away from the
chest wall are associated with very low cardiac doses in patients receiving radiation to the left
chest wall. The comparative planning does not support the use of proton beam radiation therapy,
as typically treatment with deep inspiratory breath hold using photons is associated with a mean
heart dose of less than 4 Gy. Additionally, there is a lack of level I evidence to support the use of
proton beam radiation therapy for the treatment of breast cancer. Therefore, the requested
proton beam radiation therapy is not medically necessary for the treatment of this patient.
| 1 |
A 43-year-old female enrollee has requested authorization and coverage for sacroiliac (SI) joint fusion. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees low back pain. | Upheld | Experimental | Summary Reviewer 3
A 43-year-old female enrollee has requested authorization and coverage for sacroiliac (SI) joint fusion. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees low back pain. The physician reviewer found this patient meets the criteria for a minimally invasive SI fusion. In the peer-reviewed medical literature, Polly and colleagues reported on a randomized controlled trial of 148 patients treated with minimally invasive SI joint fusion using triangular titanium implants or nonsurgical treatment with follow-up at one year. The authors concluded that this level one study showed that minimally invasive SI joint fusion using triangular titanium implants was more effective than nonsurgical management at one year in relieving pain, improving function, and improving quality of life in patients with sacroiliac joint dysfunction caused by degenerative sacroiliitis or SI joint disruptions. In another recent study, Whang and colleagues found that six month follow-up from this level one study showed that minimally invasive SI joint fusion using triangular titanium implants was more effective than nonsurgical management in relieving pain, improving function, and improving quality of life in patients with SI joint dysfunction due to degenerative sacroiliitis or SI joint disruptions. Based upon a review of the recent literature, the requested minimally invasive form of SI joint fusion is 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 52-year-old male enrollee has requested reimbursement and prospective authorization and coverage for elotuzumab (Empliciti) from 1/4/17 through 7/3/17. The Health Insurer has denied this request indicating that the medication at issue was and is considered investigational for treatment of the enrollees myeloma. | Overturned | Experimental | Summary Reviewer 3
A 52-year-old male enrollee has requested reimbursement and prospective authorization and coverage for elotuzumab (Empliciti) from 1/4/17 through 7/3/17. The Health Insurer has denied this request indicating that the medication at issue was and is considered investigational for treatment of the enrollees myeloma. The physician reviewer found that there is no dispute that pomalidomide with Empliciti and Decadron is not a compendia or literature supported regimen. As the patient has responded to Empliciti with pomalidomide and Decadron, per the National Comprehensive Cancer Network (NCCN) compendium, the continued use of Empliciti in combination with the proposed clinical trial was and is 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 medication at issue was and 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 48-year-old female enrollee has requested authorization and coverage for a Cochlear Baha Attract System. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.
In this case, the patient is suffering from unilateral profound hearing loss with normal hearing in the other ear. | Upheld | Experimental | Summary Reviewer 2
A 48-year-old female enrollee has requested authorization and coverage for a Cochlear Baha Attract System. 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 The Cochlear Baha Attract System is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The study by Gawecki and colleagues evaluated surgical, functional and audiological results of the Baha Attract System. The authors concluded that the data obtained prove the safety and effectiveness of the Baha Attract system in patients with conductive and mixed hearing loss as well as in patients with single-sided deafness. Cosmetic aspects are highly acceptable and the idea of Attract itself is important for patients with limited manual dexterity. In addition, the Cochlear Baha Attract System is U.S. Food and Drug Administration approved device for the treatment of unilateral deafness. In this case, the patient is suffering from unilateral profound hearing loss with normal hearing in the other ear. As such, the requested services 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 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. | Upheld | Experimental | Summary Reviewer 1
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 FoundationOne testing offers a comprehensive panel of molecular genetic markers on an individuals tumor with the hopes of identifying markers that can help guide therapy decision making. Per the National Comprehensive Cancer Network guidelines, it has not been determined if molecular markers are useful in treatment determination (predictive markers) and prognosis. There is currently a phase II clinical trial underway that is evaluating the efficacy of genetic molecular testing to guide individual therapy. At this time, the superior efficacy of gene testing performed on 4/19/16 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.
| 1 |
A 62-year-old male 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 medical condition. | Overturned | Experimental | Summary Reviewer 3
A 62-year-old male 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 medical condition. The physician reviewer found multiple myeloma is a cancer of plasma cells. In multiple myeloma, collections of abnormal plasma cells accumulate in the bone marrow, where they interfere with the production of normal blood cells. Most cases of multiple myeloma exhibit severe anemia. In addition, these patients will occasionally develop soft tissue tumors composed of abnormal plasma cells. The hallmark means to diagnose multiple myeloma is via laboratory demonstration of abnormal levels of specific proteins via electrophoresis. Nonsecretory myeloma is a myeloma subset which is generally characterized by demonstration of monoclonal plasma cells in the bone marrow but with negative results on serum and urine electrophoresis. In these patients, anemia is less common and renal impairment is rare. Most of these patients present with symptomatic bone lesions. As noted by Lonial and Kaufman, imaging with positron emission tomography/computed tomography (PET/CT) scans, and minimal residual disease (MRD) assessment with multi-parameter flow cytometry, may provide newer methods for response assessment, something that has been severely limited in these patients due to the lack of a reliable biomarker. Per the medical evidence, PET scan is a valuable means to evaluate and stage myeloma patients. Thus, the requested PET scan is likely to be of greater benefit than 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 |
The parent of a 15-year-old male enrollee has requested reimbursement for procalcitonin testing. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 1
The parent of a 15-year-old male enrollee has requested reimbursement for procalcitonin 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 there is sufficient support for the services at issue in this clinical setting. Maharajan and colleagues found that procalcitonin is a sensitive and specific marker in the diagnosis of septic arthritis and acute osteomyelitis. Hunziker and colleagues concluded that serum procalcitonin is a helpful diagnostic marker supporting clinical and microbiological findings for more reliable differentiation of infectious from noninfectious causes of fever after orthopedic surgery. The evidence-based medical peer-reviewed literature supports the use of procalcitonin level testing for orthopedic patients for differential diagnosis in multiple settings, including distinguishing bacterial infection from inflammatory conditions. In this case, the use of procalcitonin in follow-up of a left elbow infection after surgical debridement and completion of antibiotic therapy in an adolescent patient is consistent with the literature. Therefore, procalcitonin testing was likely to have been superior over 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.
| 0 |
A 35-year-old male enrollee has requested authorization and coverage for 64568 and 0466T. 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 3
A 35-year-old male enrollee has requested authorization and coverage for 64568 and 0466T. 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 this patient has already failed CPAP therapy. Multiple studies have demonstrated that hypoglossal nerve stimulation or Inspire airway stimulation improves health for people with obstructive sleep apnea with clinically significant decreases in observed mean apnea-hypopnea index and improvements in quality of life. The American Academy of Otolaryngology-Head and Neck Surgery considers upper airway stimulation via the hypoglossal nerve for the treatment of adult obstructive sleep apnea syndrome to be a safe and effective second-line treatment of moderate to severe obstructive sleep apnea in patients who are intolerant or unable to achieve benefit with positive pressure therapy. The International Surgical Sleep Society Position Statement states hypoglossal nerve stimulation has been shown to be effective in the treatment of sleep disordered breathing/obstructive sleep apnea in adults when applied to selected patients based on their anatomy, physiology, BMI and neck size, prior therapy and comorbidities. The medical evidence supports the requested services in this clinical setting. Thus, 64568 and 0466T are likely to be more beneficial than any available standard therapy.
| 0 |
The patient is a 12-year-old female who presented to her provider on 2/22/23. The patients
parent has requested authorization and coverage for Genotropin 12 milligram (mg)
subcutaneous (SQ) injection cartridge. The Health Insurer has denied this request and reported
that the requested medication is not medically necessary for the treatment of this patient. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 12-year-old female who presented to her provider on 2/22/23. The patients
parent has requested authorization and coverage for Genotropin 12 milligram (mg)
subcutaneous (SQ) injection cartridge. The Health Insurer has denied this request and reported
that the requested medication is not medically necessary for the treatment of this patient. The
physician reviewer found that the submitted documentation does not support the medical
necessity of the requested medication. The U.S. Food and Drug Administration (FDA) approves
the use of somatotropin therapy for the treatment of ISS, defined as a height z-score of 2.25 in
the absence of identifiable pathology. In this case, the patients original clinical presentation and
subsequent clinical course were most consistent with ISS in the context of a family history
positive for short stature. Just prior to initiation of daily GH therapy, the patient met generally
accepted diagnostic criteria for ISS. However, after nearly three and a half years of daily GH
therapy, the patients most recent PAH after cessation of daily GH therapy had improved
minimally and still overlapped the normal range for North American women. Given that this
patients PAH has been normal and consistent with her familial growth pattern, both before and
after empiric GH therapy for over three years, the requested medication is not medically
indicated. Therefore, Genotropin 12 milligram (mg) subcutaneous (SQ) injection cartridge is not
medically necessary for the treatment of this patient.
| 1 |
A 54-year-old female enrollee has requested reimbursement for color-flow Doppler echocardiography 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 chest pain and dyspnea. | Overturned | Experimental | Summary Reviewer 3
A 54-year-old female enrollee has requested reimbursement for color-flow Doppler echocardiography 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 chest pain and dyspnea. The physician reviewer found that there is sufficient support for the services at issue in this patients case. Although in general the evaluation of chest pain in the absence of physical evidence of valvular heart disease or intracardiac shunting can be accomplished without the additional performance of a color-flow Doppler examination with stress echocardiography, there is additional relevant clinical information which may be gleaned from a color-flow Doppler evaluation in the evaluation of unexplained dyspnea, which is the other cardiac symptom that this patient had. This information includes the presence of pulmonary hypertension as well as intra-atrial shunting among other diagnoses which may be silent on physical examination. The services at issue were appropriate in order to fully evaluate the patients symptoms. Thus, color-flow Doppler echocardiography performed on 3/29/18 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.
| 1 |
A 56-year-old male enrollee has requested reimbursement for DecisionDx Melanoma testing performed on 11/14/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 2
A 56-year-old male enrollee has requested reimbursement for DecisionDx Melanoma testing performed on 11/14/18. 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 this patient has an early stage melanoma. The National Comprehensive Cancer Network guidelines states 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. In addition, 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. In sum, DecisionDx-Melanoma testing performed on 11/14/18 was not likely to have been more beneficial than other methods of evaluating this patient.
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A 24-year-old male enrollee has requested reimbursement for Rituxan provided on 12/17/18. The Health Insurer has denied this request and reported that the medication at issue was not medically necessary for the treatment of the enrollees medical condition.
In this case, the patient has diagnoses of schizophrenia, OCD and PANDAS. | Upheld | Medical Necessity | Summary Reviewer
A 24-year-old male enrollee has requested reimbursement for Rituxan provided on 12/17/18. The Health Insurer has denied this request and reported that the medication at issue was not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that pediatric autoimmune neuropsychiatric disorder is a term used to describe a patient with OCD or tic disorders which are made worse by group A streptococci. The association between pediatric autoimmune neuropsychiatric disorder and group A streptococci is controversial. Furthermore, the idea that pediatric autoimmune neuropsychiatric disorder associated with streptococcus (PANDAS) is an autoimmune disorder is controversial. Immune modulating treatment is not routinely recommended. The treatment of choice for OCD includes cognitive-behavioral therapy, a selective serotonin reuptake inhibitor medication, or both. In this case, the patient has diagnoses of schizophrenia, OCD and PANDAS. Rituximab is an antineoplastic agent, monoclonal antibody immunosuppressant agent. It is not approved by the U.S. Food and Drug Administration for the treatment of OCD, schizophrenia or PANDAS. Therefore, Rituxan provided on 12/17/18 was not medically necessary for the treatment of this patient. | 1 |
A 32-year-old female enrollee has requested reimbursement for the laboratory testing provided on 6/6/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees miscarriage. | Upheld | Experimental | Summary Reviewer 1
A 32-year-old female enrollee has requested reimbursement for the laboratory testing provided on 6/6/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees miscarriage. The physician reviewer found that there are many causes of recurrent pregnancy loss including parental genetic abnormalities, uterine abnormalities and thyroid dysfunction. While some forms of autoimmune disease, such as antiphospholipid syndrome, have been associated with poor pregnancy outcomes, the role of thrombophilias remains less clear (Kaiser and Branch). The American College of Obstetricians and Gynecologists (ACOG) states that whereas meta-analyses and a retrospective cohort study have revealed an association between inherited thrombophilias and first-trimester pregnancy loss, prospective cohort studies have found no association between inherited thrombophilias and fetal loss. Accordingly, the testing done for serum homocysteine, Factor V Leiden, protein C activity, protein S activity, MTHFR, and prothrombin C20210A mutation was not medically indicated. Thus, the laboratory testing provided on 6/6/16 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 24-year-old male enrollee has requested authorization and coverage for cervical spine surgery at the C4-5 level using the Depuy VG2 allograft cervical space and Depuy Synthes Stim-line instrumentation. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition.
this patient presents with progressively worsening and severe neck, right shoulder/arm, and mid-back pain with associated headaches. Signs and symptoms have been reportedly consistent with possible cervical myelopathy, including hand clumsiness and hyperreflexia. His pain is interfering with sleep and activities of daily living. There is imaging evidence of a significant anterior osteophyte at the C5 level with history of superior endplate fracture, and degenerative changes at C4/5 without focal neural compression. There is discogram evidence of severe concordant pain at C4/5. Detailed evidence of a recent comprehensive nonoperative treatment protocol trial and failure has been submitted. The records suggest a history of dysphagia with recent improvement following discogram. | Overturned | Medical Necessity | Summary Reviewer
A 24-year-old male enrollee has requested authorization and coverage for cervical spine surgery at the C4-5 level using the Depuy VG2 allograft cervical space and Depuy Synthes Stim-line instrumentation. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that this patient presents with progressively worsening and severe neck, right shoulder/arm, and mid-back pain with associated headaches. Signs and symptoms have been reportedly consistent with possible cervical myelopathy, including hand clumsiness and hyperreflexia. His pain is interfering with sleep and activities of daily living. There is imaging evidence of a significant anterior osteophyte at the C5 level with history of superior endplate fracture, and degenerative changes at C4/5 without focal neural compression. There is discogram evidence of severe concordant pain at C4/5. Detailed evidence of a recent comprehensive nonoperative treatment protocol trial and failure has been submitted. The records suggest a history of dysphagia with recent improvement following discogram. Given the persistence of significantly abnormal findings, severe pain and functional limitations, imaging findings of cervical spondylosis with concordant findings at C4/5, and exhaustion of conservative treatment, surgical intervention is medically indicated and supported by evidence-based medical criteria. Therefore, the requested cervical spine surgery at the C4-5 level using the Depuy VG2 allograft cervical spacer and Depuy Synthes Slim-line instrumentation is medically necessary for the treatment of this patient. | 1 |
A 58-year-old female enrollee has requested reimbursement for the DecisionDX uveal melanoma (UM) multigene assay performed on 4/10/15. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees intraocular choroidal melanoma of the left eye. | Overturned | Experimental | Summary Reviewer 1
A 58-year-old female enrollee has requested reimbursement for the DecisionDX uveal melanoma (UM) multigene assay performed on 4/10/15. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees intraocular choroidal melanoma of the left eye. The physician reviewer found that DecisionDx assay is a study of 15-31 genes in an individuals melanoma cells. It has been used to classify the individuals melanoma as having either a high or low risk of metastasis. It is controversial in cutaneous melanoma as to whether it has additional value when added to the usual pathologic prognostic factors. However, there are medical studies that show the effectiveness of this assay in the analysis of prognosis for uveal melanoma (Onken, et al (2010); Onken et al (2012)). This assay is also within the guidelines of the American Joint Cancer Commission. Specifically, a class 1 category carries with it a less than 20% chance for metastasis, whereas class 2 has a greater than 70% risk of metastasis. This assay has become a standard in many ocular cancer centers and is no longer considered investigational. Its clinical value lies in determining the need for intense surveillance, and possibly to assist in the decision as to adjuvant therapy. Overall, the DecisionDX uveal melanoma multigene assay performed on 4/10/15 was likely to have been more effective than available standard modality for the evaluation of this patient. Based upon the information set forth above, the services 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 57-year-old male insured has requested authorization and coverage for intraosseous
basivertebral nerve ablation (CPT code 64628). The Health Plan has denied this request indicating
that the requested services are considered investigational for treatment of the insureds chronic
low back pain.
This
patients MRI of the lumbar spine demonstrated fibrotic type endplate
. However, the patients
MRI also showed mild central and moderate left paracentral disc protrusion, moderate left lateral
recess stenosis, | Overturned | Experimental | Summary Reviewer 1
A 57-year-old male insured has requested authorization and coverage for intraosseous
basivertebral nerve ablation (CPT code 64628). The Health Plan has denied this request indicating
that the requested services are considered investigational for treatment of the insureds chronic
low back pain. The physician reviewer found that according to the U.S. Food and Drug
Administration (FDA), intraosseous nerve ablation is intended to be used in conjunction with
radiofrequency for the ablation of basivertebral nerves for the relief of chronic low back pain of
at least six months duration that has not responded to at least six months of conservative care
and is also accompanied by features such as disruption and fissuring of the endplate. This
patients MRI of the lumbar spine demonstrated fibrotic type endplate change at L4-5 that would
make the patient a good candidate for ablation of basivertebral nerves. However, the patients
MRI also showed mild central and moderate left paracentral disc protrusion, moderate left lateral
recess stenosis, mild right and moderate left foraminal narrowing secondary to disc protrusion
and mild central canal stenosis. Thus, there are multiple plausible pathologic sources of low back
pain and finding the source of chronic lower back pain is clinically challenging (Tieppo Francio
and Sayed). A small minority low back pain diagnoses can be attributed to an anatomical source.
Overall, the medical evidence is insufficient to support a finding of spinal vertebral bodies as
being the overwhelming primary generators of the patients chronic low back pain. Therefore,
the requested intraosseous basivertebral nerve ablation (CPT code 64628) is not likely to be more
beneficial than any other available standard treatments for the patients medical condition.
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The patient is 34-year-old female. The patient has requested authorization and coverage for
Prolastin-C injection 1,000 mg for 20,000 over 28 days.
In this
case, the patient has a diagnosis of AAT deficiency with phenotype ZZ. | Overturned | Medical Necessity | Summary Reviewer
The patient is 34-year-old female. The patient has requested authorization and coverage for
Prolastin-C injection 1,000 mg for 20,000 over 28 days. The physician reviewer found that at issue
is whether Prolastin-C injection 1,000 mg for 20,000 over 28 days is medically necessary for the
treatment of this patient. The submitted documentation supports the medical necessity of the
requested service. Alpha-1 antitrypsin (AAT) is an inhibitor of the proteolytic enzyme elastase
and is essential for the maintenance of the lung parenchyma. Patients with deficiencies in AAT
develop lung destruction leading to emphysema and end-stage obstructive lung disease. In this
case, the patient has a diagnosis of AAT deficiency with phenotype ZZ. AAT deficiency with ZZ
phenotype is characterized by very low AAT levels driving precocious emphysema, and is
frequently managed with augmentation therapy with Prolastin-C. In this case, the patients ATT
levels are at 16 mg/dL, well below the minimum protective threshold of 57 mg/dL, under which
augmentation therapy is considered beneficial. While clinical guidelines and recommendations
regarding the specific indications for AAT augmentation may vary, it is generally considered
reasonable to start augmentation for non-smokers with an AAT genetic variant consistent with
severe AAT deficiency at an AAT level below 57 mg/dL and with evidence of airflow limitation, as
in this case. In this clinical setting, the requested medication is medically indicated for the
management of AAT deficiency in this patient. Therefore, Prolastin-C injection 1,000 mg for
20,000 over 28 days is medically necessary for the treatment of this patient.
| 1 |
A 32-year-old female enrollee has requested authorization and coverage for a prescription for
Qulipta 60 mg tablets. The Health Insurer has denied this request and reported that the
requested medication is investigational for the treatment of the enrollees headaches. | Upheld | Experimental | Summary Reviewer 2
A 32-year-old female enrollee has requested authorization and coverage for a prescription for
Qulipta 60 mg tablets. The Health Insurer has denied this request and reported that the
requested medication is investigational for the treatment of the enrollees headaches. The
physician reviewer found that in this case, the records document symptomatology including
photophobia, phonophobia, and nausea lasting hours to days, supporting the diagnosis of migraines. The FDA approves the use of Qulipta, a medication whose mechanism is related to the
CGRP, for the management of migraines. Ailani and colleagues noted a significant reduction of
migraine days with the use of atogepant. Goadsby and colleagues noted nearly four days of
migraine reduction with the use of Qulipta. While current medical literature supports the use of
Qulipta as a safe and effective treatment for migraines, there is a lack of evidence supporting the
superiority of Qulipta to an alternative standard therapy. Therefore, a prescription for Qulipta 60
mg tablets is not likely to be more beneficial for treatment of the patients condition than any
available standard therapy.
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A 62-year-old male has requested authorization and coverage for cervical total disc arthroplasty. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees neck pain and radiculopathy of arm.
the medical records, the provider recommended cervical total disc arthroplasty due to concern regarding adjacent segment | Upheld | Experimental | Summary Reviewer 1
A 62-year-old male has requested authorization and coverage for cervical total disc arthroplasty. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees neck pain and radiculopathy of arm. The physician reviewer found the current medical evidence has not demonstrated the superior efficacy of the requested services. Per the medical records, the provider recommended cervical total disc arthroplasty due to concern regarding adjacent segment disease. However, the literature regarding whether disc replacement prevents adjacent segment disease is equivocal. There is no clear consensus that disc arthroplasty decreases the risk of developing adjacent segment disease. In sum, the requested cervical total disc arthroplasty is not likely to be superior over other 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 |
This patient has idiopathic stature and has demonstrated improvement in growth velocity while on GH therapy. Moreover, he has had no adverse effects of therapy and has open epiphyses.
patient met most of these criteria at the time of initiation of GH therapy, and now that he has been receiving | Overturned | Medical Necessity | Summary Reviewer
This patient has idiopathic stature and has demonstrated improvement in growth velocity while on GH therapy. Moreover, he has had no adverse effects of therapy and has open epiphyses. Thus, continuation of GH therapy is medically necessary. According to the Lawson Wilkins Pediatric Endocrinology Society guidelines, a trial of GH therapy should be approved for children with otherwise unexplained short stature who pass GH stimulation tests but who meet most of the following criteria: (1) height more than 2.25 standard deviations below the mean for age or more than two standard deviations below the mid-parental height percentile; (2) growth velocity less than 25th percentile for bone age; (3) bone age more than two standard deviations below the mean for age; (4) low serum IGF-1 and/or insulin like growth factor finding protein 3 (IGFBP-3); and/or (5) other clinical features suggestive of GH deficiency. This patient met most of these criteria at the time of initiation of GH therapy, and now that he has been receiving GH therapy for over two years with good response and no adverse effects, withdrawal of therapy is not appropriate and may compromise his adult height potential. Accordingly, the requested treatment with Humatrope GH therapy is supported as medically necessary for treatment of this patients idiopathic short stature. | 1 |
A 61-year-old male 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 medical condition. | Overturned | Experimental | Summary Reviewer 3
A 61-year-old male 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 medical condition. The physician reviewer found following the diagnosis and initial treatment for prostate cancer, it is conventional to obtain sequential prostate-specific antigen levels every six to twelve months for five years. With a failure of the prostate-specific antigen levels to fall to undetectable levels, or with progressive increases in prostate-specific antigen levels, it is then common to further evaluate the patient with imaging possibly further biopsies. These additional studies will generally dictate future treatment options. For the most part, conventional bone scans will suffice. However, routine bone scans will occasionally not be diagnostic and scanning with sodium fluoride positron emission tomography/computed tomography (PET/CT) scans has been developed as a second-line scanning technique. In this patients case, the records indicate that the therapy will be dramatically altered depending on the results of the requested PET scan. If the metastatic disease is limited to a small anatomic region, this can be controlled with focal radiation. If the disease is more anatomically widespread, then he will undergo more aggressive therapy. In sum, the requested PET scan is likely to be more effective than 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.
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The patient is a 50-year-old female with a history of hyperlipidemia and hypertension. The records
note a family history of heart disease. The patient has requested authorization and coverage for
Praluent (alirocumab) 75 mg/ml injection, two injections every 28 days. The Health Insurer has
denied this request and reported that the requested medication is not medically necessary for the
treatment of this patient.
.
This patient had an LDL level of 196 mg/dl on 7/01/20. Given that this patient was intolerant to
multiple statins as well as | Overturned | Medical Necessity | Summary Reviewer
The patient is a 50-year-old female with a history of hyperlipidemia and hypertension. The records
note a family history of heart disease. The patient has requested authorization and coverage for
Praluent (alirocumab) 75 mg/ml injection, two injections every 28 days. The Health Insurer has
denied this request and reported that the requested medication 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 American College of Cardiology (ACC) has developed an expert consensus
decision pathway regarding the role of non-statin therapies for low-density lipoprotein (LDL)
lowering for management of atherosclerotic cardiovascular disease risk. Alirocumab (Praluent)
and evolocumab may be considered if the goals of therapy have not been achieved on maximally
tolerated statin and ezetimibe in higher risk patients with clinical atherosclerotic cardiovascular
disease risk or familial hypercholesterolemia. An LDL cholesterol level greater than 190 mg/dl is
considered a Class I indication for maximally tolerated statin therapy according to ACC guidelines.
This patient had an LDL level of 196 mg/dl on 7/01/20. Given that this patient was intolerant to
multiple statins as well as ezetimibe, Praluent is medically indicated. Therefore, Praluent
(alirocumab) 75 mg/ml injection, two injections every 28 days are medically necessary for the
treatment of this patient.
| 1 |
An 18-year-old female enrollee has requested authorization and coverage for Focalin XR. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees attention deficit hyperactivity disorder, combined type (ADHD).
. The treating provider has documented that the patient has already failed three of the alternatives included in the Health Insurers prescription drug list: Adderall XR, Concerta, and Metadate CD. It was also noted that when the patient was placed on Focalin XR, her symptoms had stabilized and were well-controlled. | Overturned | Medical Necessity | Summary Reviewer
An 18-year-old female enrollee has requested authorization and coverage for Focalin XR. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees attention deficit hyperactivity disorder, combined type (ADHD). The physician reviewer found the record supports the medical necessity of continued coverage of Focalin XR for treatment of this patients medical condition. The treating provider has documented that the patient has already failed three of the alternatives included in the Health Insurers prescription drug list: Adderall XR, Concerta, and Metadate CD. It was also noted that when the patient was placed on Focalin XR, her symptoms had stabilized and were well-controlled. The use of Focalin XR is medically appropriate and consistent with the standard of care in this setting. For these reasons, the requested medication is medically necessary for treatment of the patients medical condition. For the reasons set forth above, I have determined 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 51-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 5/23/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who reported bilateral breast tenderness. | Overturned | Experimental | Summary Reviewer 2
A 51-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 5/23/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who reported bilateral breast tenderness. The physician reviewer found that tomosynthesis provides advantages to radiologists interpreting mammograms. This tomographic method often allows the reader to separate dense glandular elements from underlying mass/architectural distortion, resulting in a decrease in callbacks and increase in diagnostic accuracy and detection of small cancers compared to two-dimensional imaging alone. Thus, the addition of breast tomosynthesis to the usual two-dimensional protocol was likely of greater benefit to the patient than had her mammogram been done with two-dimensional imaging alone. 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 62-year-old female has requested reimbursement for brain MRI and chest x-ray performed on 3/11/19. 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.
regarding the patients headaches and vertigo, the patient had an MRI of the brain in 2015 and CT scan in February 2019, which demonstrated similar, nonspecific findings. The office notes indicate that the patients headaches had increased in frequency over the past two years.
the patients respiratory symptoms, the patient reported increased recent dyspnea on exertion. | Overturned | Medical Necessity | Summary Reviewer
A 62-year-old female has requested reimbursement for brain MRI and chest x-ray performed on 3/11/19. 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 regarding the patients headaches and vertigo, the patient had an MRI of the brain in 2015 and CT scan in February 2019, which demonstrated similar, nonspecific findings. The office notes indicate that the patients headaches had increased in frequency over the past two years. According to the American College of Radiology (ACR) appropriateness criteria, MRI of the brain without or with contrast is considered usually appropriate in the setting of increased frequency, severity or change in character of headaches. However, MRI is not indicated for evaluation of uncomplicated vertigo. Regarding the patients respiratory symptoms, the patient reported increased recent dyspnea on exertion. According to the ACR appropriateness criteria, chest radiographs are considered usually appropriate as an initial imaging study for evaluation of non-cardiovascular dyspnea. The radiographs can detect chronic or acute findings and guide the possible need for additional imaging studies. Therefore, the services at issue were medically indicated for evaluation of the patients increasing dyspnea and increasing chronic headaches. Thus, MRI of the brain and chest x-ray performed on 3/11/19 were medically necessary for the evaluation of this patient. | 1 |
The parent of a 17-year-old male enrollee has requested reimbursement for repair of nasal vestibular stenosis performed on 8/10/18. 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.
that this patient had an acquired nasal deformity and obstruction of nasal breathing. He underwent functional rhinoplasty to restore nasal breathing. Internal valve collapse
nasal breathing. This patient had internal valve collapse with improvement with the modified Cottle maneuver. Repair of vestibular stenosis was medically indicated in this setting. The photographs clearly document collapse of the upper lateral cartilage. | Overturned | Medical Necessity | Summary Reviewer
The parent of a 17-year-old male enrollee has requested reimbursement for repair of nasal vestibular stenosis performed on 8/10/18. 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 had an acquired nasal deformity and obstruction of nasal breathing. He underwent functional rhinoplasty to restore nasal breathing. Internal valve collapse can lead to nasal obstruction. It is characterized by the collapse during inspiration of the upper lateral cartilages. A narrowing of the angle between the dorsal septum and upper laterals can also contribute, but to a lesser extent. Placement of precise cartilage grafts have been demonstrated to provide support which improves nasal breathing. This patient had internal valve collapse with improvement with the modified Cottle maneuver. Repair of vestibular stenosis was medically indicated in this setting. The photographs clearly document collapse of the upper lateral cartilage. The medical evidence supports the services at issue in this clinical setting. Therefore, repair of nasal vestibular stenosis performed on 8/10/18 was medically necessary for the treatment of this patient. | 1 |
val of the bars was performed 6/21/19. The procedure consisted of exposing the bars through the capsules bilaterally on two bars and extracting the bars after straightening. | Overturned | Medical Necessity | Summary Reviewer
excavatum. Removal of the bars was performed 6/21/19. The procedure consisted of exposing the bars through the capsules bilaterally on two bars and extracting the bars after straightening. The physician reviewer found that the submitted documentation supports the medical necessity of the services at issue. Cohen and colleagues noted that Large volume hemorrhage after Nuss bar removal is rare, but may require blood transfusion, thoracoscopic exploration, or open exploration through thoracotomy or sternotomy. Nuss bar removal should be performed in centers capable of these interventions. Bilgi and colleagues stated that Major complications after removal of the Nuss bar occur with some frequencyImmediate management of the complications may require multidisciplinary care. Because of the significant risk of significant complication requiring immediate surgical correction following double Nuss bar removal, the use of an assistant during surgery was medically indicated. Therefore, assistant surgeon services (21899-80) provided on 6/21/19 were medically necessary for the treatment of this patient. | 1 |
A 41-year-old male has requested reimbursement for a wearable cardioverter defibrillator. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees non-ischemic cardiomyopathy. The physician reviewer found this patient was diagnosed with non-ischemic cardiomyopathy and was started on medical therapy.
The patient is at risk for malignant arrhythmia and sudden death while his ejection fraction is | Upheld | Experimental | Summary Reviewer 2
A 41-year-old male has requested reimbursement for a wearable cardioverter defibrillator. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees non-ischemic cardiomyopathy. The physician reviewer found this patient was diagnosed with non-ischemic cardiomyopathy and was started on medical therapy. Current guidelines recommend three months of aggressive congestive heart failure therapy to see if the ejection fraction improves enough to obviate the need for a permanent implantable cardioverter defibrillator to prevent sudden cardiac death. There is some likelihood of recovery of left ventricular function in this instance over the initial three-month period with evidence-based medical therapy. Although implantable cardioverter defibrillators have been shown to be beneficial and indicated in both ischemic and non-ischemic cardiomyopathy, the current guidelines did not support implantable cardioverter defibrillator during the dates of service at issue. Per the guidelines, he requires a minimum of three months of evidence-based medical therapy of his left ventricular dysfunction, and then reassessment of ejection fraction prior to consideration for implantable cardioverter defibrillator. The patient is at risk for malignant arrhythmia and sudden death while his ejection fraction is low. A wearable cardioverter defibrillator can provide temporary protection from sudden death due to arrhythmia in this patient population during this interim period. Therefore, the wearable cardioverter defibrillator was likely to have been of greater benefit than other treatment options. Based upon the information set forth above, the device 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 57-year-old female enrollee has requested reimbursement for testing for cancer risk using panels of genes (MyRisk) provided on 6/05/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 2
A 57-year-old female enrollee has requested reimbursement for testing for cancer risk using panels of genes (MyRisk) provided on 6/05/19. 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 an individuals personal and/or family history may be explained by more than one inherited cancer syndrome. Thus, phenotype-directed testing based on personal and family history through a multigene panel test may be more efficient and increase the yield of detecting a pathogenic/likely pathogenic variant in a gene that will impact medical management for the patient or at-risk family members. The largest studies reporting on the outcomes of multigene testing indicate that among women tested in clinical settings, about 5 to 10 percent have a BRCA1 or BRCA2 mutation, and about 4 to 7 percent have a harmful mutation in another gene associated with high to moderate
risks of breast and/or ovarian cancer, or a mutation in a newer gene that may also be associated with increased risks for these cancers. Panel testing, such as with MyRisk, is now considered a standard of care in patients at high risk to carry a genetic mutation, such as this patient. All told, testing for cancer risk using panels of genes (MyRisk) provided on 6/05/19 was likely to have been more beneficial than other methods of evaluating this patient.
| 0 |
A 57-year-old male has requested authorization and coverage for cervical artificial disc replacement. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.
fusion. This patient presents with intractable discogenic pain and bilateral C4 motor radiculopathy. He is status post C4-C7 fusion in 2011, with onset of adjacent segment disease at C3-4 in 2012. Artificial disc replacement at the adjacent | Upheld | Experimental | Summary Reviewer 1
A 57-year-old male has requested authorization and coverage for cervical artificial disc replacement. 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 he submitted documentation fails to demonstrate the superior efficacy of the requested services. Evidence-based medical guidelines and peer-reviewed literature do not support the use of an artificial disc replacement adjacent to a prior (multilevel) anterior cervical discectomy and fusion. This patient presents with intractable discogenic pain and bilateral C4 motor radiculopathy. He is status post C4-C7 fusion in 2011, with onset of adjacent segment disease at C3-4 in 2012. Artificial disc replacement at the adjacent level has been requested for functional motion preservation. However, the use of an artificial disc replacement adjacent to prior cervical fusion is not supported by current literature. There is a lack of long-term, large volume studies to support the requested services. Therefore, the requested cervical artificial disc replacement is not likely to be more efficacious than other 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 52-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 chronic hepatitis C virus genotype 1a. | Overturned | Medical Necessity | Summary Reviewer
A 52-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 chronic hepatitis C virus genotype 1a. The physician reviewer found that due to the approval and availability of new therapies, clinical guidelines and accepted standards of care were completely revised in late 2014. According to the most recent joint guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), all patients with chronic hepatitis C, regardless of fibrosis, should be treated except those with limited life expectancy (less than 12 months) due to non-liver-related comorbid conditions. These new guideline recommendations are based on multiple randomized clinical trials, and the medication is U.S. Food and Drug Administration (FDA) approved for all patients with chronic genotype 1 hepatitis C regardless of fibrosis stage (Kowdley, et al; Afdhal, et al). Additionally, treatment of patients before they progress to F3 or F4 fibrosis is advantageous. Based on the provided records, published evidence of safety and efficacy in the published literature and clinical guidelines, the requested Harvoni is medically necessary for treatment of this patients medical condition. 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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The patient is a 28-year-old transgender female who is seeking facial feminization surgery. The Health Insurer has denied coverage for facial feminization surgery. Per the Health Insurer, the requested services are not medically necessary for the treatment of this patient. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 28-year-old transgender female who is seeking facial feminization surgery. The Health Insurer has denied coverage for facial feminization surgery. Per the Health Insurer, the requested services are 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 purpose of medically necessary facial feminization surgery is to relieve gender dysphoria. Ainsworth and Spiegel demonstrated that facial feminization surgery, like genital surgery, improved mental health-related quality of life. World Professional Association for Transgender Health, Inc. (WPATH) states, Non-genital surgical proceduresnotably facial feminization surgeryare often of greater practical significance in the patients daily life than reconstruction of the genitals. WPATH notes, These reconstructive procedures are not optional in any meaningful sense, but are understood to be medically necessary for the treatment of the diagnosed condition. The current medical evidence supports the requested services in this patients case. Therefore, the requested facial feminization surgery is medically necessary for the treatment of this patient.
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A 51-year-old male has requested reimbursement for gene expression profiling performed on 5/14/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. | Upheld | Experimental | Summary Reviewer 2
A 51-year-old male has requested reimbursement for gene expression profiling performed on 5/14/17. 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 there is a lack of support for the services at issue in this clinical setting. There is a lack of evidence from the literature that tailored follow-up according to these test results has an impact on long-term outcomes. Furthermore, prospective randomized studies to determine recurrence risk is lacking for this test. The medical evidence has not determined the superior efficacy of the services at issue. Thus, gene expression profiling performed on 5/14/17 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 72-year-old male enrollee has requested reimbursement for brachytherapy performed on 7/5/17 through 7/31/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees basal and squamous cell cancer. | Overturned | Medical Necessity | Summary Reviewer
A 72-year-old male enrollee has requested reimbursement for brachytherapy performed on 7/5/17 through 7/31/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees basal and squamous cell cancer. The physician reviewer found that there is support in the medical literature for the services at issue. Radiation therapy is an option for the initial management of small, well defined, primary cutaneous squamous cell carcinomas. It is primarily reserved for older patients and patients who are not surgical candidates due long term side effects. According to the documentation provided, this patient meets the standard criteria. Brachytherapy is the standard of care for treating this patients primary cutaneous squamous cell carcinomas. In sum, the brachytherapy performed on 7/5/17 through 7/31/17 was medically necessary for the treatment of this patients medical condition. Therefore, for the reasons stated above, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned. | 1 |
A 49-year-old female enrollee has requested reimbursement for Guardant360 CDx testing performed on 3/22/21. 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 did undergo NGS sequencing of the tumor removed at initial surgery and has had liquid NGS with Guardant360 in the past as well. | Upheld | Experimental | Summary Reviewer 2
A 49-year-old female enrollee has requested reimbursement for Guardant360 CDx testing performed on 3/22/21. 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 the NCCN guidelines recommend next generation sequencing (NGS) for pancreatic cancer patients. However, testing on tumor tissue is preferred. This patient did undergo NGS sequencing of the tumor removed at initial surgery and has had liquid NGS with Guardant360 in the past as well. Although serial liquid biopsy has been shown to help predict prognosis, its impact on therapeutic decision-making has not been demonstrated. Its role in the treatment of pancreatic cancer has yet to be defined. There is a lack of support for the use of serial liquid NGS at this time. Therefore, Guardant360 CDx testing performed on 3/22/21 was not likely to have been more beneficial for evaluation of the patientas condition than any available standard therapy.
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A 20-year-old female enrollee has requested reimbursement for residential treatment provided from 6/21/17 through 7/26/17. 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.
On 6/21/17, the patient did not have any suicidal ideation. She attended and participated in her groups and therapy sessions. She continued to have symptoms of distractibility and irritability. Per the records, the patient was compliant with her medications. She was cooperative with the staff and did not have any aggressive behavior. The patient interacted with her peers in a positive manner. The records | Upheld | Medical Necessity | Summary Reviewer
A 20-year-old female enrollee has requested reimbursement for residential treatment provided from 6/21/17 through 7/26/17. 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 that the submitted documentation fails to demonstrate the medical necessity of the services at issue. On 6/21/17, the patient did not have any suicidal ideation. She attended and participated in her groups and therapy sessions. She continued to have symptoms of distractibility and irritability. Per the records, the patient was compliant with her medications. She was cooperative with the staff and did not have any aggressive behavior. The patient interacted with her peers in a positive manner. The records do not demonstrate that the patient was a danger to herself or others during the dates of service in dispute. Based on the submitted documentation, the patient could have been treated in a less restrictive environment. Therefore, residential treatment provided from 6/21/17 through 7/26/17 was 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.
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The patient is a 16-year-old female with a past psychiatric history of attention deficit/hyperactivity
disorder, inattentive presentation, major depressive disorder, severe, recurrent episode, and
generalized anxiety disorder. The patients parent has requested reimbursement for partial
hospitalization program services provided from 12/01/21 through 12/07/21. The Health Insurer
has denied this request and reported that the services at issue were not medically necessary for the
treatment of this patient. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 16-year-old female with a past psychiatric history of attention deficit/hyperactivity
disorder, inattentive presentation, major depressive disorder, severe, recurrent episode, and
generalized anxiety disorder. The patients parent has requested reimbursement for partial
hospitalization program services provided from 12/01/21 through 12/07/21. The Health Insurer
has denied this request and reported that the services at issue were 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 American Academy of Child and Adolescent Psychiatry (AACAP)
and American Association for Community Psychiatry (AACP) have unified the Child and
Adolescent Level of Care Utilization System (CALOCUS) and the Child and Adolescent Service
Intensity Instrument (CASII) into a single instrument, the Child and Adolescent Level of
Care/Service Intensity Utilization System (CALOCUS-CASII). This instrument is a standardized
tool used to determine the intensity of services needed for children and adolescents, 6-18 years of
age, presenting with psychiatric, substance use, medical and/or developmental concerns. Using
CALOCUS-CASII, providers score patients on a scale of 1-5 using a six-pronged Dimensional
Rating System. The six dimensions include: (1) risk of harm; (2) functional status; (3) co-
occurrence of developmental, medical, substance use and psychiatric conditions; (4) recovery
environment (a. stressors and b. supports); (5) resiliency and response to services; and (6)
engagement. The composite score is then used to determine the level of care needed. For dimension
1, risk of harm, the records support a score of 3. This dimension assesses potential for harm to self
or others, or having harm inflicted upon them. The patient has attempted suicide by overdose. She
has a history of self-harm behaviors. During the period under review, the patient did not endorse
any suicidal ideation. The patient has attention deficit/hyperactivity disorder and records indicate
that she continued to have difficulty maintaining appropriate behavior without a great deal of
support. For dimension 2, functional status, the records support a score of 3. This dimension
assesses the degree to which a person is able to fulfill responsibilities within developmental
constraints. The patient has a history of school avoidance and refusal. During the period under
review, the patient struggled to stay awake in class, had difficulty completing school assignments,
and struggled to meet parental expectations around chores and activities of daily living. For
dimension 3, co-occurring developmental, medical, substance use and psychiatric conditions, the
records support a score of 2. This dimension assesses the co-existence of disorders across four
domains (psychiatric, substance use, medical or developmental) that may complicate the course of
treatment. The patient has minor co-occurrence given her psychiatric diagnoses and ongoing issues
with insomnia and poor sleep. For dimension 4A, level of stress in the recovery environment, the
records support a score of 3. This dimension assesses the stressors in the environment, social
circumstances, and interpersonal relationships. The patients recovery environment appears
moderately stressful due to longstanding school difficulties, conflictual relationship with her
mother (which has only recently begun to improve), little to no relationship with her father, and
limited peer support. There is evidence that role expectations exceed the adolescents capacity. For
dimension 4B, level of support in the recovery environment, the records support a score of 2. This
dimension assesses the presence of family and social support to augment the recovery
environment. The patients recovery environment appears supportive as evidenced by her mothers
participation in the patients treatment. For dimension 5, resiliency and response to services, the
records support a score of 3. This dimension assesses how past experiences with treatment and
recovery might indicate how the patient might respond in the future. Prior treatment has included
outpatient therapy, psychiatric medication, inpatient psychiatric hospitalization, and residential treatment. The patient exhibits moderate or equivocal resiliency/response to treatment. For
dimension 6, engagement of the patient, the records support a score of 3. The child and adolescent
sub-dimension assesses ability to form therapeutic relationship within developmental constraints.
The patient appears to be mostly engaged in her treatment. However, her attention
deficit/hyperactivity symptoms impair her ability to fully engage and appropriately utilize group
therapy sessions. She struggled to accept responsibility for her inappropriate and distracting
behaviors when they were pointed out to her, suggesting difficulty accepting even limited age-
appropriate responsibility. These findings give the patient a composite score of 19, which is
consistent with Level 3 High Intensity Community-Based Services. Therefore, partial
hospitalization program services provided from 12/01/21 through 12/07/21 were not medically
necessary for the treatment of this patient.
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A 53-year-old male enrollee has requested reimbursement for emergency department visit (99285) provided on 2/18/19. 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. | Upheld | Medical Necessity | Summary Reviewer
A 53-year-old male enrollee has requested reimbursement for emergency department visit (99285) provided on 2/18/19. 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 CPT code 99284 describes an emergency department visit for the evaluation and management of a patient, which requires these three key components: a detailed history; a detailed examination; and medical decision making of moderate complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patients and/or familys needs. Usually, the presenting problem(s) are of high severity, and require urgent evaluation by the physician, or other qualified health care professionals but do not pose an immediate significant threat to life or physiologic function. This level of billing would be an appropriate level of service in this patients case. All told, 99285 was not medically necessary for the treatment of this patient. | 0 |
The parent of a seven-year-old female enrollee has requested authorization and coverage for Avastin (bevacizumab). The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees glioblastoma multiforme. | Overturned | Medical Necessity | Summary Reviewer
The parent of a seven-year-old female enrollee has requested authorization and coverage for Avastin (bevacizumab). The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees glioblastoma multiforme. The physician reviewer found the review of the submitted documentation and relevant literature demonstrates the medical necessity for the requested medication. Brainstem gliomas are aggressive and chemotherapy options are limited. These tumors are very rare so the studies available in the medical literature are small and limited. Nevertheless, medical studies indicate that Avastin use is safe and effective. Importantly, Avastin is being used upfront along with radiation therapy where it may also have steroid-sparing function. Given the lack of standard options available to this patient, Avastin is clinically indicated. Therefore, the request for Avastin is medically necessary and appropriate in this patients case. For the reasons provided, 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 22-year-old male enrollee has requested reimbursement for substance use intensive outpatient program services from 10/14/16 through 10/28/16. 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.
Based on the documentation provided, the patient had been transitioned into a sober living housing. He participated in groups though he was noted at times to be disruptive and sarcastic. The appeal letter stated that the patient required IOP due to grieving over the loss of his father, abandonment issues from his mother, and to address obsessive thoughts.
the patient had any suicidal or homicidal ideation. There was no
that the patient was medically ill and required frequent supervision. By 10/14/16, | Upheld | Medical Necessity | Summary Reviewer
A 22-year-old male enrollee has requested reimbursement for substance use intensive outpatient program services from 10/14/16 through 10/28/16. 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 that the submitted documentation fails to demonstrate the medical necessity of the services at issue in this clinical setting. Based on the documentation provided, the patient had been transitioned into a sober living housing. He participated in groups though he was noted at times to be disruptive and sarcastic. The appeal letter stated that the patient required IOP due to grieving over the loss of his father, abandonment issues from his mother, and to address obsessive thoughts. The documentation does not state if any of these issues were addressed in the group sessions. The majority of the group sessions focused on substance treatment, sobriety, and coping with stressors. There was no documentation that the patient had any suicidal or homicidal ideation. There was no documentation that the patient was medically ill and required frequent supervision. By 10/14/16, the records indicate that the patient could have gone to community 12 step program meetings and achieved the same result. The patient could have been treated in a less restrictive environment as an outpatient with the patient attending community 12 step program meetings and working with his sponsor. Therefore, IOP services provided from 10/14/16 through 10/28/16 were not medically necessary for treatment of this patients medical condition. Based on the reasons stated above, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
The parent of a 16-year-old male enrollee has requested reimbursement for Prometheus Anser IFX diagnostic testing performed on 12/13/13. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees ulcerative colitis. | Overturned | Experimental | Summary Reviewer 2
The parent of a 16-year-old male enrollee has requested reimbursement for Prometheus Anser IFX diagnostic testing performed on 12/13/13. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees ulcerative colitis. The physician reviewer found in general, diminished or suboptimal response to infliximab or adalimumab can be managed in several ways such as shortening the interval between doses, increasing the dose, switching to a different anti-TNF agent or switching to a non-anti-TNF agent based on clinical observation in lieu of Anser IFX testing. In this patients case, the medical records submitted for review do not support acute loss of therapeutic response nor acute disease flare. 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. In addition, 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. In sum, the testing at issue was not clinically indicated and 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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The patient is a 53-year-old female with history of melanoma. The provider ordered genetic testing to assess the metastatic risk of the patients 0.4 mm Breslow depth melanoma affecting the right medial thigh. The patient has requested reimbursement for the genetic testing performed on 9/15/17. The Health Insurer denied this request for reimbursement on the basis that the services at issue were considered investigational for the evaluation of this patients medical condition. | Upheld | Experimental | Summary Reviewer 3
The patient is a 53-year-old female with history of melanoma. The provider ordered genetic testing to assess the metastatic risk of the patients 0.4 mm Breslow depth melanoma affecting the right medial thigh. The patient has requested reimbursement for the genetic testing performed on 9/15/17. The Health Insurer denied this request for reimbursement on the basis that the services at issue were considered investigational for the evaluation of this patients medical condition. The use of this type of genetic testing is not considered a standard of care in this clinical setting. The National Comprehensive Cancer Network guidelines indicate that genetic testing such as the DecisionDx-Melanoma gene assay should not be used outside of a clinical trial setting (Coit, et al). As such, the utilization of DecisionDx-Melanoma gene assay is not expected to affect the treatment or health outcome of this patients melanoma. In sum, the genetic testing performed on 9/15/17 was not likely to have been superior over the standard treatment options for 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 48-year-old female enrollee has requested reimbursement for genetic testing performed by Myriad Laboratories on 10/4/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees risk for breast or ovarian cancer syndrome.
this patient has several close relatives with cancers suggestive of a genetic cause for malignancy. The patient may have inherited a mutation from her paternal side, given her sister and cousins with breast cancer. | Upheld | Experimental | Summary Reviewer 3
A 48-year-old female enrollee has requested reimbursement for genetic testing performed by Myriad Laboratories on 10/4/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees risk for breast or ovarian cancer syndrome. The physician reviewer found that this patient has several close relatives with cancers suggestive of a genetic cause for malignancy. The patient may have inherited a mutation from her paternal side, given her sister and cousins with breast cancer. Based on this, she meets the National Comprehensive Cancer Network (NCCN) guidelines for genetic testing. The largest studies reporting on the outcomes of multigene testing indicate that among women tested in clinical settings, about 5-10% have a BRCA1 or BRCA2 mutation, and about 4-7% have a harmful mutation in another gene associated with high to moderate risks of breast and/or ovarian cancer. Thus, the genetic testing performed by Myriad Laboratories performed on 10/4/17 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 21-year-old male enrollee has requested reimbursement for polymerase chain reaction testing performed on 6/07/19. 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 the patient had complaints of aching in his penis and perineum. He was initially treated on 2/18/19 with one gram of azithromycin for these symptoms. Testing for gonorrhea and chlamydia was negative. On 4/11/19, he was seen again with a history of aching in his perineum and penis and difficulty in maintaining an erection. He was given three weeks of doxycycline. His symptoms persisted, and he had a tender prostate on physical examination. He was given ciprofloxacin for three weeks. The patients symptoms improved, but then recurred. | Upheld | Experimental | Summary Reviewer 1
A 21-year-old male enrollee has requested reimbursement for polymerase chain reaction testing performed on 6/07/19. 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 the patient had complaints of aching in his penis and perineum. He was initially treated on 2/18/19 with one gram of azithromycin for these symptoms. Testing for gonorrhea and chlamydia was negative. On 4/11/19, he was seen again with a history of aching in his perineum and penis and difficulty in maintaining an erection. He was given three weeks of doxycycline. His symptoms persisted, and he had a tender prostate on physical examination. He was given ciprofloxacin for three weeks. The patients symptoms improved, but then recurred. After referral to a urologist, broad spectrum screening by polymerase chain reaction testing was ordered. The medical evidence does not support the services at issue in this clinical setting. The testing was not directed at potential pathogens that cause prostatitis. Moreover, there is a lack of evidence in the medical literature that polymerase chain reaction screening is an effective or appropriate method to use in identifying the causes of prostatic symptoms. The patients complaint of being unable to sustain an erection is not related to prostatic infection and suggests other factors might be present. Therefore, polymerase chain reaction testing performed on 6/07/19 was not likely to have been more beneficial than other methods of evaluating this patient.
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A 63-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 6/11/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition.
. On her initial mammogram, only two views of each breast were obtained. It was after a questionable abnormality was detected that she was recalled for additional imaging including a breast sonogram and a tomosynthesis exam. This
ynthesis. In addition, she has heterogeneously dense breasts. | Overturned | Medical Necessity | Summary Reviewer 3
A 63-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 6/11/15. 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 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 particular case, the use of tomosynthesis was as a problem solving tool. On her initial mammogram, only two views of each breast were obtained. It was after a questionable abnormality was detected that she was recalled for additional imaging including a breast sonogram and a tomosynthesis exam. This is an appropriate use of tomosynthesis. In addition, she has heterogeneously dense breasts. For the reasons provided, the digital breast tomosynthesis performed on 6/11/15 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 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 four-year-old female enrollee has requested reimbursement for chromosomal microarray (CMA) genetic testing performed on 9/16/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation the enrollees developmental delays. | Overturned | Experimental | Summary Reviewer 2
The parent of a four-year-old female enrollee has requested reimbursement for chromosomal microarray (CMA) genetic testing performed on 9/16/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation the enrollees developmental delays. The physician reviewer found that the medical literature supports chromosomal microarray as the first-line for the evaluation of suspected genetic abnormalities. Coulter and colleagues showed that CMA influences medical management in a majority of the patients where an abnormality was found. Moreover, CMA is critical when clinical features suggestive of Williams syndrome are found (Sharma, et al). All told, CMA is the standard of care for evaluation of children with developmental delay. In this case, the patients positive CMA supports the chromosomal microarray genetic testing performed on 9/16/15 was likely to be more beneficial for evaluation of the patients developmental delay 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 63-year-old male enrollee has requested reimbursement for dopamine transporter imaging with a single proton emission computed tomography (DaT SPECT) scan performed on 8/24/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who presented with persistent hand tremors.
this patient benefited significantly from having the scan performed in order to confirm the cause of his tremor. | Overturned | Experimental | Summary Reviewer 2
A 63-year-old male enrollee has requested reimbursement for dopamine transporter imaging with a single proton emission computed tomography (DaT SPECT) scan performed on 8/24/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who presented with persistent hand tremors. The physician reviewer found that DaT is an acceptable diagnostic technique for the determination of Parkinsons disease. In patients where the cause of tremor is not known or is likely to be caused by other diagnoses, such as essential tremor, the use of a DaT scan can be helpful in determining the correct diagnosis. This scan has been widely used by movement disorders specialists and general neurologists when there is a question of whether a patient has Parkinsons disease. Medical studies have shown that the early diagnosis of Parkinsons disease allows for better control of symptoms and allows the patient to access available resources sooner. Accordingly, this patient benefited significantly from having the scan performed in order to confirm the cause of his tremor. All told, DaT SPECT scan performed on 8/24/16 was likely to have been more effective than other available modalities in evaluating this patient. 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.
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The patient is a 47-year-old male with a periodic fever syndrome clinically consistent with a
diagnosis of tumor necrosis factor associated periodic syndrome (TRAPS). The patient has
requested authorization and coverage for llaris (canakinumab) injection 150 mg/ml, #1/56 day. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 47-year-old male with a periodic fever syndrome clinically consistent with a
diagnosis of tumor necrosis factor associated periodic syndrome (TRAPS). The patient has
requested authorization and coverage for llaris (canakinumab) injection 150 mg/ml, #1/56 day.
The physician reviewer found that the submitted documentation supports the medical necessity
of the requested medication. TRAPS is a rare autoinflammatory disorder caused by genetic
variations in the tumor necrosis factor receptor 1 (TNFR1) gene. Symptoms of TRAPS can include
recurrent fever, myalgias and chest pain. A diagnosis of TRAPS is established based on history
and physical examination after other causes of fever, such as infection, malignancy and other
autoimmune diseases, have been excluded. There are no specific laboratory tests, outside of
genetic testing, that can assist with establishing the diagnosis of TRAPS, and genetic testing is not
consistently conclusive. Preventing recurrent attacks from uncontrolled TRAPS is important in
reducing the risk of amyloidosis development, a complication of this disorder. Treatment with
TRAPS includes NSAIDs, which only result in symptom relief in 75% of patients and do not
effectively control disease related inflammation. Corticosteroids can provide a short-term
reduction in inflammation for patients with TRAPS. IL-1 inhibition with canakinumab is effective
and is currently the only approved treatment for TRAPS. De Benedetti and colleagues conducted
a randomized trial to evaluate the efficacy and safety of canakinumab in patients with the
following periodic fever syndromes: colchicine-resistant familial Mediterranean fever,
mevalonate kinase deficiency, and TRAPS. At week 16, significantly more patients with TRAPS
receiving canakinumab had a complete treatment response compared to placebo, 45% versus
8%. In addition, the inclusion of patients whose canakinumab dose was increased to 300 mg every
four weeks led to a complete treatment response in 73% of study participants with TRAPS.
Furthermore, after the 16-week period, disease control was maintained in 53% of persons with
TRAPS using canakinumab every eight weeks. In this case, the patient did not have an adequate
treatment response to NSAIDs or prednisone in the past. Treatment with canakinumab was noted
to be effective therapy for this patients TRAPS per the submitted medical record. As indicated
by the randomized trial above, canakinumab is effective and appropriate for the treatment of
this patients disorder. Further delay of appropriate treatment with canakinumab can have
serious health consequences for this patient, as the development of amyloidosis is a serious
complication of this disease. Therefore, llaris (canakinumab) injection 150 mg/ml, #1/56 day is
medically necessary for the treatment of this patient.
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A 58-year-old female enrollee has requested reimbursement for Afirma Thyroid Fine Needle Aspiration Analysis gene testing performed on 11/18/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 2
A 58-year-old female enrollee has requested reimbursement for Afirma Thyroid Fine Needle Aspiration Analysis gene testing performed on 11/18/14. 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 that the submitted documentation fails to demonstrate the superior efficacy of the services at issue in this patients case. In this case, the cytopathology report was consistent with suspicion of follicular neoplasm. This finding carries a risk of malignancy of 35%. The genetic marker was consistent with suspicion for malignancy, which raises the risk of malignancy to 40%. Submitting the specimen to Afirma testing was useful to confirm the recommendation for surgery. However, it did not change the risk to change the recommendation. In sum, Afirma testing did not provide additional benefit to the patient which would have altered patient management. 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 26-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 4/15/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. | Upheld | Experimental | Summary Reviewer 3
A 26-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 4/15/19. 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 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 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. Therefore, DecisionDx-Melanoma testing performed on 4/15/19 was not likely to have been more beneficial than other available standard therapy.
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The patient is a 31-year-old male with rectal bleeding and pain with bowel movements since July 2020 who has been diagnosed with an anal fissure. The patient has requested authorization and coverage for Botox (onabotulinumtoxinA for injectable 100 unit). The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 31-year-old male with rectal bleeding and pain with bowel movements since July 2020 who has been diagnosed with an anal fissure. The patient has requested authorization and coverage for Botox (onabotulinumtoxinA for injectable 100 unit). The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The physician reviewer found that Botox injection is a standard of care treatment option for fissures that do not respond to medical management. According to the Clinical Practice Guideline for the Management of Anal Fissure from the American Society of Colon and Rectal Surgeons, Compared with topical nitrates, the use of calcium channel blockers for chronic anal fissures has a similar efficacy, with a superior side effect profile, and can be used as first-line treatment. The guideline also notes, Botulinum toxin has similar results compared with topical therapies as first-line therapy for chronic anal fissures, and modest improvement in healing rates as second-line therapy following treatment with topical therapies. It is not standard of care to require treatment with both nitroglycerin and a calcium channel blocker. Botox is a standard treatment option for fissures that do not respond to medical management. An alternative to Botox is lateral internal sphincterotomy, but this has potential for complications, including fecal incontinence. It is medically appropriate to pursue Botox injections prior to consideration for surgery. Therefore, Botox (onabotulinumtoxinA for injectable 100 unit) is medically necessary for the treatment of this patient.
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A 32-year-old female enrollee has requested authorization and coverage for Enbrel. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees ankylosing spondylitis. | Overturned | Experimental | Summary Reviewer 2
A 32-year-old female enrollee has requested authorization and coverage for Enbrel. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees ankylosing spondylitis. The physician reviewer found that Enbrel is appropriate for this patients diagnosis of ankylosing spondylitis. However, if the patient does have systematic lupus erythematosus, than it is not suggested to use Enbrel or other anti-tumor necrosis factor (TNF) agents as these drugs can trigger lupus. Given the presentation in the records, the patient does not have systematic lupus erythematosus, rather she carries a low titer double stranded deoxyribonucleic acid (dsdna) antibody which is being monitored. Thus, the requested Enbrel is 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 medication 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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The patient is a 62-year-old female who is status post mastectomy with lymph node dissection in June 2020. The patient has requested reimbursement for hospital admission provided from 9/29/20 through 10/01/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient.
, the patient developed an acute unilateral breast hematoma following previous subpectoral placement of a tissue expander. An arterial bleeder was identified, and the hematoma was evacuated in the operating room. She was admitted for two days of inpatient hospital stay. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 62-year-old female who is status post mastectomy with lymph node dissection in June 2020. The patient has requested reimbursement for hospital admission provided from 9/29/20 through 10/01/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The physician reviewer found that there is a lack of support for the services at issue in this clinical setting. Schwartz stated, As surgical procedures become less morbid with decreased operative times, less postoperative pain, and quicker recovery, the benefits of hospital admission become less significant and same-day discharge is possible without compromising outcomes, patient safety, or satisfaction. Oxley and colleagues performed a study of same day discharge after immediate post-mastectomy alloplastic breast reconstruction. The authors noted, Any patients with high-risk anesthetic histories, ASA III or above or significant sleep apnea are admitted for a planned overnight stay at the hospital. All other patients (ASA II or lower) are treated as same day discharge procedures, either at the hospital or day care clinicSame day discharge following IPMABR (immediate post-mastectomy alloplastic breast reconstruction) is safe and greatly reduces resource use. In this case, the patient developed an acute unilateral breast hematoma following previous subpectoral placement of a tissue expander. An arterial bleeder was identified, and the hematoma was evacuated in the operating room. She was admitted for two days of inpatient hospital stay. There is no history of intercurrent disease or of increased anesthesia or postoperative risk factors. No special postoperative monitoring was required, and her recovery was uneventful. Drainage was reduced markedly by the morning following the procedure. Based on the medical records received for review, there is no indication that inpatient hospital care was required as contrasted to observation care. Therefore, hospital admission provided from 9/29/20 through 10/01/20 was not medically necessary for the treatment of this patient.
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patient is a 40-year-old male with chronic left-sided low back pain. He has tried physical therapy as well as medications. The patient has requested authorization and coverage for arthrodesis sacroiliac joint, percutaneous or minimally invasive. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient.
This patient has localized pain to the sacroiliac joint. This pain has responded to anesthetic injection, indicating that the sacroiliac joint is the pain generator. The patient has | Overturned | Medical Necessity | Summary Reviewer
The patient is a 40-year-old male with chronic left-sided low back pain. He has tried physical therapy as well as medications. The patient has requested authorization and coverage for arthrodesis sacroiliac joint, percutaneous or minimally invasive. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The physician reviewer found that there is sufficient support for the requested services in this clinical setting. This patient has localized pain to the sacroiliac joint. This pain has responded to anesthetic injection, indicating that the sacroiliac joint is the pain generator. The patient has failed reasonable nonsurgical treatments, and the current high-level evidence supports minimally invasive fusion to have superior outcomes to further conservative care. Therefore, arthrodesis sacroiliac joint, percutaneous or minimally invasive is medically necessary for the treatment of this patient.
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A 55-year-old male enrollee has requested reimbursement for partial hospitalization program (PHP) services provided from 8/15/16 through 9/21/16. 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.
On 8/15/16, the patient reported no depression, inattention, anxiety or suicidality. He was eating 100% of his meals, sleeping 10 hours per night and he was not prescribed psychotropic medication. He did not have psychiatric or medical co-morbidity. He was actively engaged in treatment and looking forward to being drug free. | Upheld | Medical Necessity | Summary Reviewer
A 55-year-old male enrollee has requested reimbursement for partial hospitalization program (PHP) services provided from 8/15/16 through 9/21/16. 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 that the the PHP services provided from 8/15/16 through 9/21/16 were not medically necessary. Although chemical dependency treatment was clinically indicated, the record does not support the medical necessity for PHP level of care during the dates in dispute. On 8/15/16, the patient reported no depression, inattention, anxiety or suicidality. He was eating 100% of his meals, sleeping 10 hours per night and he was not prescribed psychotropic medication. He did not have psychiatric or medical co-morbidity. He was actively engaged in treatment and looking forward to being drug free. In sum, the record does not demonstrate that comprehensive, evidence-based services provided in an outpatient program would have been unsafe or inadequate to address this patients medical condition. All told, the patient could have been treated at a less restrictive setting as of 8/15/16. 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 58-year-old female 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 chronic hepatitis C virus genotype 1b. | Overturned | Medical Necessity | Summary Reviewer
A 58-year-old female 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 chronic hepatitis C virus genotype 1b. The physician reviewer found that according to the most recent joint guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), all patients with chronic hepatitis C virus, regardless of fibrosis, should be treated except those with a life expectancy of less than 12 months due to non-liver-related comorbid conditions. In addition, treatment naive patients are recommended to be treated with Harvoni for 12 weeks. These recommendations are based on multiple randomized clinical trials, and the medication is U.S. Food and Drug Administration (FDA) approved for all patients with chronic hepatitis C genotype 1 regardless of fibrosis stage. Moreover, it is beneficial to treat patients with hepatitis C before they progress to F3 or F4 fibrosis. For these reasons, the requested treatment with Harvoni is supported as medically necessary for treatment of this patients hepatitis C virus infection. Based on the foregoing discussion, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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The patient is a 22-year old female who has diagnoses of bipolar disorder type I with recent manic with psychotic features, currently depressed, posttraumatic stress disorder, concern for borderline personality disorder, eating disorder and gender dysphoria. The records indicated the patient was unresponsive to current treatment. The patient has had trials of antidepressants in combination with augmenting atypical antipsychotics and other agents without significant benefit. The patient has a history of four past psychiatric hospitalizations. The provider indicated that the purpose of the testing was to
. The provider progress note dated 11/13/15 was included for review. This progress note indicated the genetic testing results. The patient may have reduced enzyme activity compared to persons with the normal phenotype. She was noted to be heterozygous for serotonin transporter and this was associated with increased time to respond to selective serotonin reuptake inhibitors (SSRI) medications. The treatment plan included avoiding antidepressant (SSRI) medications due to her diagnosis of bipolar disorder,
of Prazosin due to nightmares, continuation of lurasidone due to her bipolar disorder and continuation of lamotrigine for mood stabilization. The patient has requested reimbursement for the genetic testing performed on 11/10/15. The Health Insurer denied the request for reimbursement and reported that the services at issue were investigational for the evaluation of this patients medical condition. | Upheld | Experimental | Summary Reviewer 3
The patient is a 22-year old female who has diagnoses of bipolar disorder type I with recent manic with psychotic features, currently depressed, posttraumatic stress disorder, concern for borderline personality disorder, eating disorder and gender dysphoria. The records indicated the patient was unresponsive to current treatment. The patient has had trials of antidepressants in combination with augmenting atypical antipsychotics and other agents without significant benefit. The patient has a history of four past psychiatric hospitalizations. The provider indicated that the purpose of the testing was to identify potential challenges in metabolizing future antidepressant and/or augmentation agents. The provider progress note dated 11/13/15 was included for review. This progress note indicated the genetic testing results. The patient may have reduced enzyme activity compared to persons with the normal phenotype. She was noted to be heterozygous for serotonin transporter and this was associated with increased time to respond to selective serotonin reuptake inhibitors (SSRI) medications. The treatment plan included avoiding antidepressant (SSRI) medications due to her diagnosis of bipolar disorder, establishing psychological therapeutic care with emphasis on coping and safety promoting skills with consideration of dialectic behavior therapy due to a concern for possible borderline personality disorder, prescription of Prazosin due to nightmares, continuation of lurasidone due to her bipolar disorder and continuation of lamotrigine for mood stabilization. The patient has requested reimbursement for the genetic testing performed on 11/10/15. The Health Insurer denied the request for reimbursement and reported that the services at issue were investigational for the evaluation of this patients medical condition. The evidence based data does support the use of pharmacogenomic testing in cases like this one. In a review by Kirchheiner and colleagues, they noted that there is still considerable controversy on whether adjustment of dosage driven by genetic information may improve therapeutic efficacy, and/or adverse events is prevented, to an extent of any practical importance in clinical practice. Instead, there is strong evidence based support for medication and psychotherapy in this patients case. It is not clear that medication and psychotherapy have been used in an evidence based manner for treatment of this patient. The literature recommends further prospective validation in the routine application of pharmacogenetic dose adjustment. Additionally, while the record notes that this patient continues to struggle with symptoms of her mental illness, the supplied materials do not indicate that the patient has failed evidence based psychotherapy trials. The documentation provided does not indicate that the patient has failed medication trials of adequate dose and duration. It is also unclear whether the patient has attempted psychotherapy. The supplied materials do not indicate what the problematic symptoms are and do not indicate what symptoms are not under control or what the patients functional status was at the time of the testing. Further, one of the mainstays of treatment for borderline personality disorder is dialectical behavior therapy, which can occur on an outpatient basis. Yet, the record does not indicate that this has been done in this patients case. Accordingly, the current evidence based literature indicates that the patient could have potentially benefited from psychotherapy for her behavioral health conditions. For these reasons, the genetic testing performed on 11/10/15 was not likely to have been more beneficial than the standard available options for the evaluation of 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 58-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 7/10/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 2
A 58-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 7/10/15. 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 medical literature supports breast tomosynthesis in this patients case. Per Skaane and colleagues, the use of mammography plus tomosynthesis in a screening environment resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers. Ciatto and colleagues noted that integrated two-dimensional and three-dimensional mammography improves breast cancer detection and has the potential to reduce false positive recalls. Thus, the breast tomosynthesis performed on 7/10/15 was 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 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 64-year-old male enrollee has requested reimbursement for PET scan performed on 8/31/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
scan on 8/31/18 followed a conventional CT and was indicated for the patients condition. | Overturned | Experimental | Summary Reviewer 1
A 64-year-old male enrollee has requested reimbursement for PET scan performed on 8/31/18. 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 there is sufficient support for the services at issue in this clinical setting. The use of positron emission tomography (PET) scans in staging and restaging colon cancer has been proven to be more sensitive for residual or recurrent colon cancer than computed tomography (CT) or magnetic resonance imaging (MRI) alone. The physiologic activity of metastases or local recurrence makes PET a more sensitive test for tumor than conventional imaging. The PET scan on 8/31/18 followed a conventional CT and was indicated for the patients condition. Therefore, PET scan performed on 8/31/18 was likely to have been of greater benefit than other methods of evaluating this patient.
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A 29-year-old male enrollee has requested reimbursement for chiropractic services provided on 2/03/16, 2/08/16 and 2/15/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees spinal enthesopathy, segmental and somatic dysfunction of cervical region, and sprain of ligaments of thoracic spine.
/16. The records note that the patient was receiving additional units of therapy in addition to spinal and extraspinal manipulation per visit. | Upheld | Medical Necessity | Summary Reviewer
A 29-year-old male enrollee has requested reimbursement for chiropractic services provided on 2/03/16, 2/08/16 and 2/15/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees spinal enthesopathy, segmental and somatic dysfunction of cervical region, and sprain of ligaments of thoracic spine. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the services at issue. The clinical records do not support the need for the chiropractic services provided on 2/03/16, 2/08/16 and 2/15/16. The records note that the patient was receiving additional units of therapy in addition to spinal and extraspinal manipulation per visit. This is considered excessive, and the medical evidence does not support the services at issue in this clinical setting. There is a lack of high-grade scientific evidence to support passive physical modalities such as traction and massage/myofascial release for neck and upper back complaints. All told, chiropractic services provided on 2/03/16, 2/08/16 and 2/15/16 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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The patient is a 16-year-old female who has a history of a left knee anterior cruciate ligament reconstruction with a quadriceps tendon autograft in September 2018. The patientas parent has requested authorization and coverage for physical therapy. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 16-year-old female who has a history of a left knee anterior cruciate ligament reconstruction with a quadriceps tendon autograft in September 2018. The patientas parent has requested authorization and coverage for physical therapy. 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 literature related to rehabilitation after anterior cruciate ligament (ACL) reconstruction supports early weight bearing, early range of motion exercise, and closed kinetic chain activities. The early rehabilitation process should be monitored closely to protect against graft failure and other complications. As strength improves, open kinetic chain activities and more functionally advanced work can be introduced, although demanding physical activity is generally avoided during the first three postoperative months. Rehabilitation following ACL reconstruction, overall, can require a prolonged period of time. The entire rehabilitation process following ACL reconstruction, however, does not requires a formal therapy setting. Home-based programs have been shown to result in similar long-term outcomes to more clinically supervised programs, particularly for the recreational sports participant. The rehabilitation process can be more complicated, however, particularly for return to activities placing significant stress on the knee. Regaining higher level neuromuscular control of core muscles and optimizing other biomechanics factors are important to improve functional outcomes and mitigate risk of re-injury of the repaired ACL, as well as contralateral knee injury. Assessment and treatment of the injured knee, as well as the addressing of potentially disadvantageous compensatory biomechanics is appropriate for a comprehensive rehabilitation program following ACL repair. Ultimately, each rehabilitation program needs to be reviewed on an individual basis, depending on the specific functional needs in each case. Therapy protocols after meniscal repair typically call for avoiding weight bearing and excessive range of motion in the early postoperative period. There is, however, no clear evidence-based consensus on optimal protocols, as accelerated and more aggressive programs have also been shown to have benefit, particularly when meniscal repairs are performed in association with an ACL reconstruction. In any case, a period of supervised formal therapy following meniscal repair is warranted to initiate the program, followed by a transition to self-directed exercises when possible and appropriate. In the current case, the patient underwent a right knee ACL reconstruction with quadriceps autograft, as well as medial and lateral meniscus repairs in early March 2020. Postoperatively, she had a slow recovery of her range of motion but ultimately gained full extension and functional flexion. She had complaints with various activities such as walking on uneven surfaces, but there are no indications that she has any limitations with her mobility-related activities of daily living at that time. Although the patient has not fully recovered from her right knee surgery, the medical necessity of the requested additional 24 therapy visits is not established. There are no exercises that she is performing in the formal therapy setting that could not be performed independently or substituted with independent exercise. There are no indications that she is unable to do an appropriate home exercise program. At this stage many months postoperatively, and with full knee extension already established long ago, there is no benefit of ongoing formal manual therapy over stretching and use of self-applied modalities (e.g., foam rollers) that can be performed independently. She will have a guarded prognosis with respect to future injuries if she continues to participate in activities and sports such as soccer, but the additionally proposed therapy in question is not expected to marginally improve her risk profile. Therefore, the requested physical therapy is not medically necessary for the treatment of this patient. | 1 |
A 63-year-old female enrollee has requested authorization and coverage for an iris prosthesis. 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 medical records state that the patient has advanced glaucoma. The patient says that she has a glare from her traumatic aniridia. She also states that she desires to undergo this procedure to improve the cosmetic appearance of her abnormal eye. | Overturned | Experimental | Summary Reviewer 3
A 63-year-old female enrollee has requested authorization and coverage for an iris prosthesis. 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 medical records state that the patient has advanced glaucoma. The patient says that she has a glare from her traumatic aniridia. She also states that she desires to undergo this procedure to improve the cosmetic appearance of her abnormal eye. In this patientas case, placement of an iris prosthesis is unlikely to improve her functional vision; there is a greater chance that significant complications may result. She currently uses a custom contact lens, without apparent complications. Therefore, the requested iris prosthesis is not likely to be more beneficial for the treatment of this patient than any available standard therapy.
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A 61-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 10/31/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 3
A 61-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 10/31/18. 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 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 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, DecisionDx-Melanoma testing performed on 10/31/18 was not likely to have been more beneficial than other methods of evaluating this patient.
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A 62-year-old male enrollee has requested reimbursement for gene testing for prostate cancer performed on 4/21/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition.
Moreover, the patient was determined to be at an intermediate risk, based on Gleason score of | Overturned | Experimental | Summary Reviewer 1
A 62-year-old male enrollee has requested reimbursement for gene testing for prostate cancer performed on 4/21/15. 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 the testing at issue was not likely to be more effective for this patient than other available treatment options. Bostrom and colleagues performed a literature review of the use of genomic biomarkers in the prognostication of prostate cancer outcome and prediction of therapeutic response. The authors indicated that genomic testing in prostate cancer is in its infancy and it is yet unknown how to use results in clinical practice. Moreover, the patient was determined to be at an intermediate risk, based on Gleason score of 7. Per National Comprehensive Cancer Network (NCCN) guidelines, viable options for treatment include prostatectomy or pre radiation androgen deprivation therapy, followed by radiation therapy. For the reasons provided, the genomic testing 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 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 51-year-old female enrollee has requested reimbursement for Anser IFX testing performed on 4/15/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease. | Upheld | Experimental | Summary Reviewer 3
A 51-year-old female enrollee has requested reimbursement for Anser IFX testing performed on 4/15/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found this patient had symptoms, primarily diarrhea, while on Remicade suggestive of loss of response. Inadequate response or loss of response can occur for many reasons. However, the appropriate method for determination of cause for symptoms while on therapy is not clear. The use of Anser IFX to investigate inadequate response and direct subsequent management has not been clinically proven to improve patient clinical outcomes or alter patient management. The effectiveness of Anser IFX in management of Crohns disease compared to conventional courses of action remains unproven 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, with many patients who have these antibodies maintaining their response. In sum, the superior efficacy of Anser IFX testing performed on 4/15/14 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 59-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 9/26/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic. | Overturned | Experimental | Summary Reviewer 1
A 59-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 9/26/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic. The physician reviewer found that breast tomosynthesis provides advantages to radiologists interpreting mammograms. This tomographic method often allows the reader to separate dense glandular elements from underlying mass/architectural distortion, resulting in a decrease in callbacks and increase in overall diagnostic accuracy and detection of small cancers compared to two-dimensional imaging alone. Thus, the addition of breast tomosynthesis to the usual two-dimensional protocol was likely of greater benefit to this patient than had her examination been done with two-dimensional imaging alone. 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.
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A 58-year-old male enrollee has requested reimbursement for therapeutic phlebotomy from
1/6/21 through 1/26/21. The Health Insurer has denied this request and reported that the service
at issue was investigational for the treatment of the enrollees hereditary hemochromatosis.
, the patient has evidence of iron overload with organ damage based on liver biopsy result
and MRI of the | Overturned | Experimental | Summary Reviewer 3
A 58-year-old male enrollee has requested reimbursement for therapeutic phlebotomy from
1/6/21 through 1/26/21. The Health Insurer has denied this request and reported that the service
at issue was investigational for the treatment of the enrollees hereditary hemochromatosis. The
physician reviewer found that hereditary hemochromatosis is an inherited disorder most
commonly caused by a point mutation in the HFE gene, typically C282Y, or less commonly by
other genes related to iron regulation such as H63D. Most of these disorders result in increased
intestinal iron absorption that can eventually cause serious tissue damage. The goal of treatment
in hereditary hemochromatosis is to prevent organ dysfunction from excess iron and/or to
improve organ function if it has already been affected. Patients with iron overload, or at risk for
iron overload, are treated with phlebotomy. Patients who cannot tolerate phlebotomy, for
example, due to concomitant anemia, may be treated with an iron chelator instead if their iron
overload is significant. Patients without iron overload who have a hereditary hemochromatosis
genotype, such as homozygosity for HFE C282Y or compound heterozygosity for C282Y and
another HFE variant, may be monitored regularly. The American College of Gastroenterology
supports phlebotomy for hereditary hemochromatosis with evidence of iron overload. In this
case, the patient has evidence of iron overload with organ damage based on liver biopsy result
and MRI of the liver. Therefore, therapeutic phlebotomy from 1/6/21 through 1/26/21 was likely
to have been more beneficial for treatment of the enrollee's condition than any available
standard therapy.
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A 40-year-old female enrollee has requested reimbursement for homocysteine testing and polymerase chain reaction testing for EBV performed on 8/08/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 3
A 40-year-old female enrollee has requested reimbursement for homocysteine testing and polymerase chain reaction testing for EBV performed on 8/08/18. 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 Homocysteine has not been found to be a risk factor for cardiovascular disease and should not be ordered as a routine for this purpose. Homocysteine levels may be useful in evaluating patients who are symptomatic of B12 deficiency, but have normal or borderline B12 levels. The medical records do not indicate findings consistent with B12 deficiency, such as macrocytic anemia or psychiatric complaints. It appears that B12 therapy was planned to be continued regardless of homocysteine level results. Thus, homocysteine testing and polymerase chain reaction testing for Epstein Barr virus performed on 8/08/18 were not likely to have been more effective than other methods of evaluating this patient.
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The parent of a four-month-old male enrollee has requested reimbursement for the nitric oxide therapy provided from 11/4/16 through 11/7/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees respiratory distress syndrome.
found that the patient was born at 28 weeks gestation on 11/2/16 and had neonatal respiratory distress syndrome causing pulmonary hypertension. The patient was intubated and treated with three doses of surfactant. Despite this treatment, on 11/4/16 the patient was hypoxic with oxygen saturation decreasing into the 60% range. An echocardiogram revealed pulmonary hypertension. | Overturned | Medical Necessity | Summary Reviewer
The parent of a four-month-old male enrollee has requested reimbursement for the nitric oxide therapy provided from 11/4/16 through 11/7/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees respiratory distress syndrome. The physician reviewer found that the patient was born at 28 weeks gestation on 11/2/16 and had neonatal respiratory distress syndrome causing pulmonary hypertension. The patient was intubated and treated with three doses of surfactant. Despite this treatment, on 11/4/16 the patient was hypoxic with oxygen saturation decreasing into the 60% range. An echocardiogram revealed pulmonary hypertension. As noted by the U.S. Food and Drug Administration (FDA), inhaled nitric oxide is a pulmonary vasculature dilator approved treatment for neonatal pulmonary distress syndrome with pulmonary hypertension. The pulmonary hypertension must be treated immediately to prevent large shunting of deoxygenated blood. Given this indication, the inhaled nitric oxide provided to this patient from 11/4/16 through 11/7/16 was consistent with standard of care and therefore was medically necessary. Based on the foregoing discussion, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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patient is a 19-year-old male who has a long history of back and shoulder pain. He has been seen by a chiropractor on multiple occasions and has been treated conservatively. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 19-year-old male who has a long history of back and shoulder pain. He has been seen by a chiropractor on multiple occasions and has been treated conservatively. The physician reviewer found that there is a lack of support for the services at issue in this clinical setting. Pain is a common complaint, and not everyone who has pain needs a CT or MRI scan. As a fundamental principle, an imaging study is only worthwhile if it will affect the management of the patient. In this patient, especially considering the negative thoracic spine CT scan, the likelihood of detecting a significant abnormality that would have changed the management was minimal. The fact that the patient had a negative CT scan of the thoracic spine would exclude likely culprits (in a patient of this age) such as a scoliosis, mild degenerative change, or anatomic variations such as a hemivertebral body. In the absence of any of these findings, especially in a young active patient who has a recent history of hurting his back after playing sports, the likelihood of MRI providing any significant information is minimal.
As has been shown in multiple studies, incidental finding of degenerative disease or disc abnormality is exceedingly common in asymptomatic individuals. It is well known that some patients with substantial MRI findings will not have symptoms, and conversely, some patients with minimal signs on MRI will have pronounced symptoms. The American College of Radiology has established aAppropriateness Criteriaa to help referring physicians obtain efficient use of imaging modalities to evaluate various clinical presentations. While they have not established specific criteria for thoracic spine pain, they have established these criteria for chronic neck and low back pain. MRI is felt to be anot usually appropriatea in the management of chronic pain without other red flags. This patient had no symptoms other than pain, which he reports having had for at least the last year. There is no evidence of radiculopathy, prior tumor, or infection. The medical evidence does not support the services at issue in this patientas case. Therefore, the MRI performed on 7/01/20 was not medically necessary for the evaluation of this patient.
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A 61-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 10/31/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 1
A 61-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 10/31/18. 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 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 a bit to these statistics. DecisionDx-Melanoma testing is a study of 31 genes in an individuals melanoma cells. It then classifies that particular melanoma based on the five-year risk of metastasis. Gerami and colleagues reported on 217 cases, with a good correlation between the DecisionDx-Melanoma testing and prognosis in patients who have had sentinel node biopsy. Berger and colleagues reported on 156 cases, but there was not sufficient follow-up to determine the real value of the assay. It is not clear how the five-year DecisionDx-Melanoma testing data compares to the ten-year Balch data. Most importantly, it is not known if the DecisionDx-Melanoma testing result can be used to make clinical decisions. Therefore, DecisionDx-Melanoma testing performed on 10/31/18 was not likely to have been more beneficial than other methods of evaluating this patient.
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