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A 55-year-old female enrollee has requested reimbursement for the spinal surgery and one day inpatient services provided on 1/8/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees low back pain with radiation down the right leg.
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Overturned
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Medical Necessity
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Summary Reviewer
A 55-year-old female enrollee has requested reimbursement for the spinal surgery and one day inpatient services provided on 1/8/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees low back pain with radiation down the right leg. The physician reviewer found that per the North American Spine Society (NASS) recommendations, this patient meets the criteria for the spinal surgery performed and one day inpatient services provided on 1/8/17. Lumbar fusion is indicated for spinal stenosis with qualifying criteria, when appropriate. These criteria include cases in which decompression will likely result in iatrogenic instability, such as foraminal stenosis, during which greater than 50% of the facet joint will be removed to adequately decompress the exiting nerve root. Per the NASS guidelines, the criteria for lumbar laminotomy include a pattern of radiculopathy/neurogenic claudication explained by imaging findings and 6-12 weeks of non-operative treatment. In this patient, the criteria have been satisfied as there is proper documentation of 6-12 weeks of non-operative treatment being performed. In addition, based upon the spinal stenosis at the foraminal level, decompression would have resulted in iatrogenic instability and therefore the requested stabilization at the L4-S1 level was medically necessary. All told, the records provided for review support the medical necessity of the spinal surgery and one day inpatient services provided on 1/8/17 for treatment of this patients low back pain and lumbar radiculopathy. 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.
| 1 |
A 57-year-old female enrollee has requested reimbursement for anesthesia services provided on 2/06/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollee, who underwent colonoscopy.
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Overturned
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Medical Necessity
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Summary Reviewer
A 57-year-old female enrollee has requested reimbursement for anesthesia services provided on 2/06/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollee, who underwent colonoscopy. The physician reviewer found that according to the American Society of Anesthesiologists guideline for anesthesia care during endoscopic procedures, monitored anesthesia care is warranted in patients with a history of failed moderate sedation, which applies to this case of a patient with a seizure after moderate sedation in the past. According to other published criteria, allergies to sedation medications are a reason for use of monitored anesthesia care. According to the most recent guidelines from the American Society for Gastrointestinal Endoscopy, monitored anesthesia care is recommended for previously anticipated intolerance to standard sedatives, as in this case of a seizure after midazolam. Thus, anesthesia services provided on 2/06/18 were medically necessary 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.
| 0 |
The parent of a 14-year-old male enrollee has requested reimbursement for Prometheus Anser IFX diagnostic testing performed on 10/7/14. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees Crohns disease.
this case, the patient appeared to be losing response to Remicade and
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Overturned
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Experimental
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Summary Reviewer 1
The parent of a 14-year-old male enrollee has requested reimbursement for Prometheus Anser IFX diagnostic testing performed on 10/7/14. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees Crohns disease. The physician reviewer found the Prometheus Anser IFX diagnostic testing performed on 10/7/14 was likely to be more effective for this patient than other available treatment options. The testing at issue has become the standard of care for providers to determine whether the patient will benefit from the drug. Prometheus Anser IFX testing informs the provider if the serum levels of drug are in the range to be beneficial and effective or if they have antibodies that could potentially lead to a reaction or failure to respond. This helps guide the provider in dosing or may lead to discontinuation of the drug if the patient is not likely to benefit from the medication. This prevents the patient from having a flare-up and also prevents potential side effects of a drug the patient may not benefit from. In this case, the patient appeared to be losing response to Remicade and Prometheus Anser IFX testing allowed for the provider to determine if antibodies are present or if the patient needs a higher dose of the medication to prevent from a flare-up with further consequences. Therefore, the Prometheus Anser IFX testing was appropriate for the management of the patients Crohns disease and 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 57-year-old female with a history of lumbar degenerative changes and adjacent segment disease following a fusion at L4-5 with herniations L2 to S1 and degenerative spondylolisthesis at L3-4. The patient has requested authorization and coverage for laminectomy PLIF surgery and two (2) inpatient bed days. 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 a history of lumbar degenerative changes and adjacent segment disease following a fusion at L4-5. The records document low back pain. She has chronic herniations and neural foraminal stenosis at multiple levels from L2 to S1 and degenerative spondylolisthesis at L3-4.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 57-year-old female with a history of lumbar degenerative changes and adjacent segment disease following a fusion at L4-5 with herniations L2 to S1 and degenerative spondylolisthesis at L3-4. The patient has requested authorization and coverage for laminectomy PLIF surgery and two (2) inpatient bed days. 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 there is sufficient support for the requested services in this clinical setting. This patient has a history of lumbar degenerative changes and adjacent segment disease following a fusion at L4-5. The records document low back pain. She has chronic herniations and neural foraminal stenosis at multiple levels from L2 to S1 and degenerative spondylolisthesis at L3-4. A review of the current medical literature with regard to the laminectomy/decompression and PLIF indicates that it remains safe and effective, with a high percentage of pain relief and achieving a solid bony fusion. Therefore, laminectomy PLIF surgery and two (2) inpatient bed days are medically necessary for the treatment of this patient.
| 1 |
A 48-year-old female enrollee has requested reimbursement for lab testing (Factor V Leiden genetic testing) provided on 12/16/14. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 1
A 48-year-old female enrollee has requested reimbursement for lab testing (Factor V Leiden genetic testing) provided on 12/16/14. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. There is a lack of current medical recommendation from national societies, including the American College of Obstetrics and Gynecology (ACOG), for such screening before the prescribing or use of HRT. Such testing in the general population has not been shown to impact on the safety or risk of using HRT across the population. The ACOG Bulletin on prevention of deep vein thrombosis (DVT) addresses who would benefit from such testing stating Because of the high prevalence of the Factor V Leiden mutation in the Caucasian population, all patients who are not Hispanic, Asian, or African American and have a history of DVT may be tested. In non-Caucasian patients, the decision to test should be individualized. Patients with histories of extensive or recurrent thrombosis or family histories of thrombosis may have the Factor V Leiden mutation in combination with another congenital or acquired disorder. In this case, the patient was asymptomatic with no personal or family history of thrombosis. The testing performed was not indicated or likely to be more beneficial for evaluation of the patients medical condition than other modalities. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
A 59-year-old male enrollee has requested reimbursement for gene testing performed on 3/9/15. The Health Plan has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 2
A 59-year-old male enrollee has requested reimbursement for gene testing performed on 3/9/15. The Health Plan 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 gene testing performed on 3/9/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. In this case, the initial biopsy report was determined to be indeterminate. The Afirma testing showed a suspicious lesion, which was a determining factor in delineating the further course of action to assess whether a surgical procedure was warranted. Afirma testing is considered standard protocol on fine needle aspirations performed on thyroid nodules. In sum, 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 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 36-year-old female insured has requested reimbursement for laser hair removal performed on
10/25/22.
that the insured was diagnosed with hidradenitis
suppurativa at the axillae and groin two years ago, which worsened with pregnancy. The Health
Insurer indicates the services at issue were considered investigational for the treatment of the
insured's medical condition. Therefore, the Health Insurer has denied reimbursement for the
services at issue.
the patient
has a history of hidradenitis suppurativa that was treated with laser hair
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Upheld
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Experimental
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Summary Reviewer 2
A 36-year-old female insured has requested reimbursement for laser hair removal performed on
10/25/22. A review of the record indicates that the insured was diagnosed with hidradenitis
suppurativa at the axillae and groin two years ago, which worsened with pregnancy. The Health
Insurer indicates the services at issue were considered investigational for the treatment of the
insured's medical condition. Therefore, the Health Insurer has denied reimbursement for the
services at issue. This denial is the subject of this appeal and determination. The physician reviewer
found that there are several options are available for the treatment of patients with hidradenitis
suppurativa, including medical and surgical modalities. However, there is a paucity of studies
comparing medical treatments to surgical treatments. According to the United States and Canadian
Hidradenitis Suppurativa Foundations, oral antibiotics such as clindamycin, rifampicin, and
ertapenem, other medical treatments such as infliximab and adalimumab, and surgical treatments
such as laser therapy and surgical excision, are all considered standard therapies for the treatment
of patients with hidradenitis suppurativa (Alikhan, et al.; Goldburg, et al.). In this case, the patient
has a history of hidradenitis suppurativa that was treated with laser hair removal. While laser hair
removal is a treatment option, the current medical literature has not established its benefits over
other standard therapies, including oral antibiotics. There is a lack of documentation indicating
that the patient tried oral antibiotics such as clindamycin, rifampicin, and ertapenem. For these reasons, the laser hair removal performed on 10/25/22 was not likely to be more beneficial for the
treatment of the patients condition than any available standard therapy.
| 1 |
The patient is a 70-year-old male. The patient has requested reimbursement for foreign claim
Mexico, ambulance transportation on 4/30/21.
the patient received emergency medical services on 4/30/21. In
this case, the patient had a life-threatening injury with significant risk of morbidity and mortality
resulting in neurologic deficits that had the potential
. The patient had an emergent neurosurgical procedure performed for the same
reasons. He did not have access to neurosurgical care to receive his life and brain-saving
treatment at the hospital in Mexico.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 70-year-old male. The patient has requested reimbursement for foreign claim
Mexico, ambulance transportation on 4/30/21. The physician reviewer found that submitted
documentation supports that the patient received emergency medical services on 4/30/21. In
this case, the patient had a life-threatening injury with significant risk of morbidity and mortality
resulting in neurologic deficits that had the potential to worsen and become irreversible with any
treatment delay. The patient had an emergent neurosurgical procedure performed for the same
reasons. He did not have access to neurosurgical care to receive his life and brain-saving
treatment at the hospital in Mexico. Prompt treatment and the use of an ambulance in this
emergency situation was justified and necessary. Non-medical transportation in this clinical
setting would have posed a substantial risk of potential worsening of morbidity and potential
mortality as patients with worsening neurologic deficits, as in this case, require close medical
monitoring both during the hospital stay and when being transported between hospitals.
Therefore, foreign claim Mexico, ambulance transportation on 4/30/21 was an emergency
medical service and medically necessary for the treatment of this patient.
| 1 |
The patient is a 13-year-old male with extreme short stature and growth hormone deficiency (GHD). The patients parent has requested authorization and coverage for Norditropin Flexpro 30 mg/3 ml. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient.
His height is severely compromised, and he has been growing poorly. Per the growth chart, the patient has experienced growth failure over several years. The
. In sum, the patient has demonstrated growth failure, low IGF-1 levels and predicted adult height less than mid-parental height.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 13-year-old male with extreme short stature and growth hormone deficiency (GHD). The patients parent has requested authorization and coverage for Norditropin Flexpro 30 mg/3 ml. 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 current medical evidence supports the requested medication in this patients case. His height is severely compromised, and he has been growing poorly. Per the growth chart, the patient has experienced growth failure over several years. The growth velocity is less than the third percentile of normal range. In sum, the patient has demonstrated growth failure, low IGF-1 levels and predicted adult height less than mid-parental height. His presentation is consistent with growth hormone deficiency with a severe delay in bone age. In this setting, growth hormone is a standard of care. Therefore, Norditropin Flexpro 30 mg/3 ml is medically necessary for the treatment of this patient.
| 1 |
A 54-year-old male has requested reimbursement for Anser VDZ test provided on 7/17/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ulcerative colitis.
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Upheld
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Experimental
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Summary Reviewer 3
A 54-year-old male has requested reimbursement for Anser VDZ test provided on 7/17/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ulcerative colitis. The physician reviewer found that there is insufficient medical evidence to support the effectiveness of Anser VDZ compared with conventional courses of action in the management ulcerative colitis. The published studies including the use of anti-Entyvio antibodies and serum levels are small, retrospective, and/or observational rather than controlled (in regards to the study of using Entyvio levels and anti-Entyvio antibody levels) in nature, preventing firm conclusions about cause and effect. Additionally, the antibodies can be transient. Controlled studies are lacking to show that use of the test results in improved long-term health outcomes for patients with ulcerative colitis compared with conventional management. For these reasons, Anser VDZ test provided on 7/17/17 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.
| 1 |
A 37-year-old female enrollee has requested authorization and coverage for Gilenya. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees multiple sclerosis.
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Overturned
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Medical Necessity
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Summary Reviewer
A 37-year-old female enrollee has requested authorization and coverage for Gilenya. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees multiple sclerosis. The physician reviewer found that Gilenya is a disease-modifying therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of multiple sclerosis. One of the major challenges of treating patients with multiple sclerosis is prescribing a regimen that is effective and also regimen with which the patient will comply. Even if a therapy is effective, if a patient does not comply then it is unlikely the therapy will be effective. In this patients case, Gilenya is a therapy that is effective and one which the patient is compliant as it fits her lifestyle. There is sufficient support for the requested medication in this clinical setting. All told, Gilenya is medically indicated for the treatment of this patient. Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 38-year-old male enrollee has requested reimbursement for acute inpatient psychiatric treatment provided from 1/03/17 through 1/09/17. 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.
that the patient was partially cooperative in treatment. He began to refuse to take his psychotropic medication towards the end of his stay. It did not appear that his refusal to take medication had any serious impact on his mental health symptoms. On numerous occasions, he was noted to be at his baseline.
His continued stay appeared due to lack of placement options and a need for sobriety, not due to uncontrolled psychiatric symptoms
or nursing care. The patient did not express suicidal ideation or severe mood lability during the disputed period.
patient had an inability to fulfill responsibilities and obligations.
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Upheld
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Medical Necessity
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Summary Reviewer
A 38-year-old male enrollee has requested reimbursement for acute inpatient psychiatric treatment provided from 1/03/17 through 1/09/17. 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 the progress notes from the disputed period indicate that the patient was partially cooperative in treatment. He began to refuse to take his psychotropic medication towards the end of his stay. It did not appear that his refusal to take medication had any serious impact on his mental health symptoms. On numerous occasions, he was noted to be at his baseline. The progress notes do not reflect severe psychiatric symptoms that necessitated inpatient treatment. His continued stay appeared due to lack of placement options and a need for sobriety, not due to uncontrolled psychiatric symptoms requiring 24-hour psychiatric or nursing care. The patient did not express suicidal ideation or severe mood lability during the disputed period. In cases such as this, an evidence-based, objective, instrument such as the American Association of Community Psychiatrists Level of Care Utilization System (LOCUS) for Psychiatric and Addiction Services is indispensable in determining necessary level of care for adults. Based on this tool, the patients risk of harm was consistent with a score of 3. The risk of harm was low due to a lack of current suicidal ideation. The records support a score of 3 in terms of functional status. The patient had an inability to fulfill responsibilities and obligations. With regards to medical, addictive and psychiatric comorbidity, the records support a score of 3. In terms of level of stress of the recovery environment, the records support a score of 2. There was potential for exposure to substances. In terms of level of support of recovery environment, the records support a score of 3. The patient had a positive relationship with mother who cooperated in family therapy on a regular basis. With regards to treatment and recovery history, the records support a score of 3. There was minimal treatment response in the past. In terms of engagement and recovery status, the records support a score of 4. Thus, the patient has a composite score of 21. A score of between 20 and 22 correlates with partial hospital program level of care. It appears that the patients main problems leading to his functional impairment were largely due to his alcohol use. The American Society of Addiction Medicine Adult Patient Placement Criteria for level of placement can be applied to the patients presentation to help determine the appropriate level of care. With regards to acute intoxication and/or withdrawal potential, the patient has a risk rating score of 0 due to lack of withdrawal. In terms of biomedical condition and complications, the patient has a risk rating score of 1 due to mild active medical problems. With regards to emotional/behavioral or cognitive conditions and complications, the patient has a risk rating score of 2 indicating issues that are stable with a lack of suicidal ideation or severe mood or psychotic symptoms. In terms of readiness to change, the patient has a risk rating of 2 due to minimal motivation. With regards to relapse, continued use, or continued problem potential, the patient has a risk rating of 3 due to a minimal period of sobriety. In terms of recovery/living environment, the patient has a risk rating of 3 due to a difficulty with sober placements. Overall, the patients presentation suggests risk rating scores in the range of 0 to 3. This overall risk rating is consistent with clinically managed low intensity residential services, 24-hour structure with trained personnel, such as halfway houses. In sum, acute inpatient psychiatric treatment provided from 1/03/17 through 1/09/17 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.
| 1 |
A 63-year-old female enrollee has requested reimbursement for FoundationOne CDx TM
comprehensive genomic profiling test performed on 1/26/21. The Health Insurer has denied this
request and reported that the services at issue were investigational for the evaluation of the
enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 1
A 63-year-old female enrollee has requested reimbursement for FoundationOne CDx TM
comprehensive genomic profiling test performed on 1/26/21. 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 understanding the molecular
drivers of cancer progression and metastases is an area of ongoing and active research,
predominantly driven by the goal of identifying specific genomic aberrations that may ultimately
result in individualized cancer treatment. In addition to likely providing prognostic information,
the value of next generation sequencing to predict candidates for specific mutation-driven
treatment holds promise. Patients with inflammatory and metastatic breast cancers benefit from
next generation sequencing to identify markers that may indicate benefit from targeted
treatment or clinical trials. For hormone receptor-positive/HER2-negative breast cancer, testing
for PIK3CA mutations with tumor or liquid biopsy to identify candidates for alpelisib plus
fulvestrant should be performed. In addition, molecular markers can indicate response to
immunotherapy. The medical evidence supports the services at issue in this setting. Therefore,
FoundationOne CDx TM comprehensive genomic profiling test performed on 1/26/21 was likely
to have been more beneficial than any available standard therapy.
| 0 |
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.
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Upheld
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Experimental
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Summary Reviewer 2
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 Homocysteine level testing is supported in cases of anemia and bleeding disorders. This testing may also be used to characterize etiology of B12 deficiency. However, homocysteine level testing lacks data supporting its utility as a standard test in the evaluation of peripheral neuropathy. Wile and Toth noted that homocysteine testing is not supported in routine testing for peripheral neuropathy but may be used in diabetic neuropathy. All told, the homocysteine testing performed on 3/9/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 56-year-old female enrollee has requested reimbursement for gene test (Breast Cancer Index) performed on 1/6/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee who had a history of breast cancer.
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Upheld
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Experimental
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Summary Reviewer 1
A 56-year-old female enrollee has requested reimbursement for gene test (Breast Cancer Index) performed on 1/6/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee who had a history of breast cancer. The physician reviewer found that patients with early stage disease typically undergo primary surgery (lumpectomy or mastectomy) to the affected breast and regional lymph nodes with or without radiation therapy. Adjuvant therapy may be offered based on primary tumor characteristics which include: tumor size, grade, number of involved lymph nodes, the status of the hormone receptors and expression of the HER2 receptor. The Breast Cancer Index (BCI) test is a validated test that can predict the likelihood of benefit from extended endocrine therapy; prognostic for the risk of late distant recurrence in N0 and N1 patients. It is a test intended for use in patient diagnosed with estrogen receptor positive, lymph node negative or lymph node positive (1 to 3) early stage invasive breast cancer. The published studies validating or evaluating the use of the BCI resulted in a change in treatment plan in 26% of cases in which endocrine therapy was being considered. Based on National Comprehensive Cancer Network guidelines, patients with tumor characteristics as demonstrated by this patient, T2N0 ER/PR positive and HER2 negative, invasive breast cancer, 21 gene reverse transcription polymerase chain reaction (RT-PCR) testing should be conducted. The risk of recurrence score should guide the use of adjuvant endocrine therapy and/or chemotherapy. Although the Breast Cancer Index test has been validated, it is not considered in the current standard guidelines. The studies available indicate that it has similar ability to detect low and high risk of recurrence and that it has resulted in a change in clinical practice. However, there is a lack of long term follow up data of its use in this clinical setting. As such, the services at issue were not likely to be more effective than the standard options available for 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.
| 1 |
The patient is a 21-year-old female with chronic urticarial eruption and severe atopic dermatitis. The
patient has requested authorization and coverage for Dupixent. The Health Insurer has denied this request
and reported that the requested medication is not medically necessary for the treatment of this patient.
this case, the patient has failed numerous medications, including topical and systemic medications, and is
currently being treated with Dupixent.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 21-year-old female with chronic urticarial eruption and severe atopic dermatitis. The
patient has requested authorization and coverage for Dupixent. 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
submitted documentation supports the medical necessity of the requested medication. The U.S. Food and
Drug Administration (FDA) approves the use of Dupixent for the treatment of severe atopic dermatitis. In
this case, the patient has failed numerous medications, including topical and systemic medications, and is
currently being treated with Dupixent. In this clinical setting, the requested medication is medically
indicated. Therefore, Dupixent is medically necessary for the treatment of this patient.
| 1 |
A 40-year-old female enrollee has requested reimbursement for the Genecept Assay provided by Genomind, Inc. on 2/24/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees major depressive disorder.
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Upheld
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Experimental
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Summary Reviewer 3
A 40-year-old female enrollee has requested reimbursement for the Genecept Assay provided by Genomind, Inc. on 2/24/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees major depressive disorder. The physician reviewer found that the records provided for review do not specify the type of medications, dosage, length of time, and outcome for this patient. It was not mentioned if the patient was tried on different classes of antidepressants or concomitantly, or if augmentation strategies were attempted. There is no evidence in the records provided that electroconvulsive therapy (ECT) was discussed with the patient. Per community standard, ECT would be the next likely consideration in a patient with treatment refractory depression. Currently, ECT remains the most powerful treatment modality for patients with treatment resistant depression, with a proven track record of higher frequency of response and remission in these cases. Studies have shown that clinically useful predictors in genetic testing are scarce for antidepressant therapy, with results being inconsistent. At best, studies have shown that there is only marginal clinical association between enzyme system variants and drug metabolism, efficacy, and tolerability in the treatment of depression. In addition, there is a lack of large randomized trials supporting its use. The existing studies have also indicated that there was no significant correlation between either genotypes or medication serum concentration and response treatment. Current evidence does not support the use of genotyping when choosing an antidepressant, and even less is understood about its use in the treatment of anxiety disorders. Genetic testing lacks evidence based research to show its effective use in guiding the provider towards choosing a medication regimen. All told, the Genecept Assay provided by Genomind, Inc. on 2/24/16 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.
| 1 |
A 50-year-old female has requested authorization and coverage for sacroiliac joint fusion. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.
of complex regional lumbosacral pain syndrome with multiple pain generators. Her history suggests likely pain generation from intervertebral disc and facet joints.
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Upheld
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Experimental
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Summary Reviewer 2
A 50-year-old female has requested authorization and coverage for sacroiliac joint fusion. 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 the submitted documentation fails to demonstrate the superior efficacy of the requested services. This patients history supports a diagnosis of complex regional lumbosacral pain syndrome with multiple pain generators. Her history suggests likely pain generation from intervertebral disc and facet joints. The reliance of steroid local injection into the sacroiliac joint is not sufficient to localize pain generation from the sacroiliac joint in the face of multifactorial chronic pain. Many patients experiencing chronic inflammation at the sacroiliac joint have minimal symptoms. The study by Wise and colleagues is a prospective cohort study with limited number of patients. The study is not blinded as to procedure and is vulnerable to selection bias, evaluation bias and placebo effect. In the article by Schoell and colleagues, the authors identified 469 patients who had undergone minimally invasive sacroiliac fusion between 2007 and 2014. Overall complication rates were 13.2% at 90 days after surgery and 16.4% at six months after surgery. The authors concluded that minimally invasive sacroiliac joint fusion could possibly carry higher risks of complications than had been previously stated. In sum, the requested sacroiliac joint fusion 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 64-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 considered investigational for treatment of the enrollees prostate cancer.
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Upheld
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Experimental
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Summary Reviewer 3
A 64-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 considered investigational for treatment of the enrollees prostate cancer. The physician reviewer found that there are several clinical publications for safety and efficacy of proton beam radiation for prostate cancer. However, there is a lack of randomized trials demonstrating superior clinical outcome of proton beam for prostate cancer over commonly used intensity modulated radiation therapy (IMRT). Most providers have recommended additional study on the long-term safety and efficacy of protons compared with photons before adopting protons as a viable treatment option for prostate cancer. The National Comprehensive Cancer Network (NCCN) guideline state that proton beam therapy for primary treatment of prostate cancer should only be performed within the context of a prospective clinical trial or within prospective registries. Given these findings, the requested proton beam radiation therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. 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 30-year-old male enrollee has requested reimbursement for Prometheus Anser IFX diagnostic testing performed on 6/16/14. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees Crohns disease.
, the patient has Crohns disease and was started on Remicade in February 2014. Several months post Remicade treatment he had recurrent symptoms of diarrhea despite adequate response initially on Remicade.
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Upheld
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Experimental
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Summary Reviewer 3
A 30-year-old male enrollee has requested reimbursement for Prometheus Anser IFX diagnostic testing performed on 6/16/14. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees Crohns disease. The physician reviewer found in this case, the patient has Crohns disease and was started on Remicade in February 2014. Several months post Remicade treatment he had recurrent symptoms of diarrhea despite adequate response initially on Remicade. Due to the multitude of management options once a patient has no response to Remicade and the fact that Remicade has a wide array of adverse effects, it is important for the treating provider to have a roadmap of the nature of the patients clinical course. ADA testing provides important and significant management implications, and was clinically indicated in this case. Based upon the information set forth above, the testing 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 24-year-old male enrollee has requested reimbursement for services provided from 5/10/15 through 8/05/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees behavioral health conditions.
The patient also had social skills and language deficits that were a main focus of treatment.
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Upheld
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Experimental
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Summary Reviewer 3
A 24-year-old male enrollee has requested reimbursement for services provided from 5/10/15 through 8/05/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees behavioral health conditions. The physician reviewer found there is substantial literature to support the use of cognitive behavioral therapy for the patients symptoms. However, the literature for wilderness adventure therapy programs is not robust in relation to treating these issues. The majority of the literature on the wilderness adventure therapy programs is for children and adolescents. In this patients case, it is not clear that less restrictive resources were not available or appropriate for the patients needs. The documentation does not support failure of outpatient therapy, intensive outpatient therapy, partial hospital program therapy or cognitive behavioral therapy. Based on the records, it is not clear that the services provided would have been more beneficial than typical evidence-based treatments for the patients anxiety issues as well as his functional issues due to his anxiety. The patient also had social skills and language deficits that were a main focus of treatment. The documentation does not support failures of community-based services and evidence based treatments, such as cognitive behavioral therapy, which is a mainstay for anxiety and social anxiety symptom treatment. Behavioral health therapy should be started in the least restrictive and most similar to home-type environment available. This is due to the fact that skills learned in therapy will generalize better to a home-type environment. Skills learned in an artificial environment are known to not generalize as well as those learned in a home-type environment. In this patients case, he could have safely been treated in a less restrictive setting. Thus, services provided from 5/10/15 through 8/05/15 were not likely to have been superior over other treatment alternatives in this patients case. 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.
| 1 |
A 59-year-old female insured has requested authorization and coverage for Rinvoq 45 mg tablets
(30 tablets every 30 days). The Health Insurer has denied this request indicating that the requested
medication is considered investigational for the treatment of the insured's Chron's disease.
In this case,
the patient presents with a history of Crohn's disease. The patient has tried and failed treatment
with standard biologic therapy agents such as budesonide, high-d
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Overturned
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Experimental
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Summary Reviewer 1
A 59-year-old female insured has requested authorization and coverage for Rinvoq 45 mg tablets
(30 tablets every 30 days). The Health Insurer has denied this request indicating that the requested
medication is considered investigational for the treatment of the insured's Chron's disease.
The physician reviewer found that the medical literature has established Rinvoq as a safe and
effective treatment option for patients with Crohn's disease. In one study by Sandborn and
colleagues involving patients with Crohn's disease, Rinvoq demonstrated a significant increase in
efficacy for all doses tested as compared with placebo, with the efficacy maintained for one year.
Rinvoq is also U.S. Food and Drug Administration (FDA) approved for the treatment of patients
with Crohn's disease. A recent study of high-dose, 45 mg Rinvoq demonstrated safety findings
consistent with previous studies, with no new safety risks observed (Sandborn, et al.). In this case,
the patient presents with a history of Crohn's disease. The patient has tried and failed treatment
with standard biologic therapy agents such as budesonide, high-dose infliximab with azathioprine,
and high-dose Stelara with azathioprine. Without an effective treatment, the patient is at risk for
complications including stricture, fistula, and a need for surgery or hospitalization. Rinvoq is FDA-
approved and supported by the medical literature for the treatment of patients with Crohn's disease.
Given these findings, the requested Rinvoq 45 mg tablets (30 tablets every 30 days) are likely to
be more beneficial for the treatment of the patients condition than any available standard therapy.
| 1 |
The parent of a 14-year-old female enrollee has requested reimbursement for the Anser IFX testing performed on 2/24/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees medical condition.T
, the patient was apparently in remission at the time of testing, with labs
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Upheld
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Experimental
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Summary Reviewer 3
The parent of a 14-year-old female enrollee has requested reimbursement for the Anser IFX testing performed on 2/24/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees medical condition.The physician reviewer found checking infliximab levels and antibodies has been demonstrated to be helpful in guiding clinical decision making when there is concern for a loss of response to infliximab. However, in this case, the patient was apparently in remission at the time of testing, with labs drawn to proactively monitor infliximab levels and antibodies. While this approach is being studied, there is not yet robust evidence that it will improve clinical outcomes. Vaughn and colleagues performed a retrospective observational study of proactive monitoring of infliximab troughs and antibodies. The authors found that among the 48 patients with proactive monitoring, the likelihood of remaining on infliximab (presumably due to sustained response) was higher than for controls. While this approach is certainly promising, and may well become standard of care in future, at this point it is not the standard of care. Therefore, the Anser IFX diagnostic testing performed on 2/24/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 42-year-old female enrollee has requested authorization and coverage for Aimovig 140 mg dose, two auto-injections. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition.
This patient has failed numerous first-line therapies for headache. More recently, she has demonstrated benefit with Aimovig.
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Overturned
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Medical Necessity
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Summary Reviewer
A 42-year-old female enrollee has requested authorization and coverage for Aimovig 140 mg dose, two auto-injections. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that Aimovig has been approved by the U.S. Food and Drug Administration for migraine headache. This patient has failed numerous first-line therapies for headache. More recently, she has demonstrated benefit with Aimovig. There is sufficient medical evidence supporting the use of Aimovig for patients with chronic headache. It would not be in this patients best interest to be required to discontinue Aimovig in favor of another medication (Botox) which may have possible side effects for this patient. Continued use of Aimovig is medically reasonable and indicated in this case. Therefore, Aimovig 140 mg dose, two auto-injectors are medically necessary for the treatment of this patient.
| 1 |
A 62-year-old female enrollee has requested reimbursement for ChemoFX assay performed on 5/08/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 3
A 62-year-old female enrollee has requested reimbursement for ChemoFX assay performed on 5/08/15. 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 in vitro drug testing on patients tumor cells prior to applying chemotherapy is an appealing 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 2004. In their review of this technology, the panel concluded that such in vitro drug testing should be limited to clinical trials. There is a lack of support for the services at issue in this clinical setting. Therefore, ChemoFx assay performed on 5/08/15 was not likely to have been more effective than other methods of evaluation. 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 |
The patient is a 64-year-old male who has been diagnosed with melanoma. The patient has requested reimbursement for unlisted multianalyte assay with algorithmic analysis performed on 12/18/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of this patient.
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is a 64-year-old male who has been diagnosed with melanoma. The patient has requested reimbursement for unlisted multianalyte assay with algorithmic analysis performed on 12/18/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of this patient. The physician reviewer found that the National Comprehensive Cancer Network guidelines state, aCommercially available gene expression profiling (GEP) tests are marketed as being able to classify cutaneous melanoma into separate categories based on risk of metastasis. However, it remains unclear whether these tests provide clinically actionable prognostic information when used in addition to or in comparison with known clinicopathologic factors or multivariable nomograms that incorporate patient sex, age, tumor location and thickness, ulceration, mitotic rate, lymphovascular invasion, microsatellites, and sentinel lymph node biopsy status. Furthermore, the impact of these tests on treatment outcomes or follow-up schedules has not been established.a This patient has an early stage melanoma without adverse pathologic features. There is a lack of support for the services at issue in this clinical setting. Therefore, unlisted multianalyte assay with algorithmic analysis performed on 12/18/19 was not medically necessary for the evaluation of this patient.
| 1 |
A 62-year-old male enrollee has requested authorization and coverage for proton beam therapy.
The Health Insurer has denied this request and reported that the requested service is
investigational for the treatment of the enrollees prostate cancer.
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Upheld
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Experimental
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Summary Reviewer 2
A 62-year-old male enrollee has requested authorization and coverage for proton beam therapy.
The Health Insurer has denied this request and reported that the requested service is
investigational for the treatment of the enrollees prostate cancer. The physician reviewer found
that there is a lack of evidence in current medical literature to suggest that treatment with proton
therapy is associated with a clinical benefit when compared to standard treatment. There are no
comparative randomized studies validating the efficacy of proton therapy as compared to
standard treatment with photons. There is insufficient clinical data to discern whether treatment
with proton beam radiation offers a clinical benefit compared to conventional radiation therapy
techniques in the treatment of prostate cancer. In a multi-institutional analysis of 1,850 patients
with low or intermediate risk prostate cancer that compared groups receiving hypofractionated
radiation proton therapy and intensity modulated radiation therapy (IMRT) with photons,
Vapiwala and colleagues found no significant difference in gastrointestinal or genitourinary
toxicities between the two treatments. Further, the authors found no difference in disease
control between the two modalities. The American Society of Radiation Oncology (ASTRO) states, Proton beam therapy for primary treatment of prostate cancer should only be performed within
the context of a prospective clinical trial or registry. ASTRO further notes that the comparative
efficacy evidence of proton beam therapy with other prostate cancer treatments is still being
developed, and thus the role of proton beam therapy for localized prostate cancer within the
current availability of treatment options remains unclear. The National Comprehensive Cancer
Network (NCCN) guidelines for the treatment of prostate cancer note no clear benefit of proton
therapy over standard treatment with photons and IMRT. Therefore, proton beam therapy is not
likely to be more beneficial for treatment of the patients condition than any available standard
therapy.
| 1 |
A 58-year-old female enrollee has requested reimbursement for MammaPrint testing performed on 1/21/14. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for the evaluation of the enrollees breast cancer.
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Upheld
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Experimental
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Summary Reviewer 1
A 58-year-old female enrollee has requested reimbursement for MammaPrint testing performed on 1/21/14. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for the evaluation of the enrollees breast cancer. The physician reviewer found the testing provided on 1/21/14 was not likely to be more effective for this patient than other available treatment options. The National Comprehensive Cancer Network (NCCN) guidelines state MammaPrint is approved by the [U.S. Food and Drug Administration] FDA to assist in assignment of women with ER-positive or ER-negative breast cancer into a high versus low risk for recurrence, but not for predicting benefit from adjuvant system therapy. NCCN guidelines further state that studies using MammaPrint as a prognostic or predictive tool are too small and/or retrospective in nature. In sum, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
The parent of a 17-year-old male enrollee has requested reimbursement for Prometheus Anser IFX testing performed on 6/30/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 3
The parent of a 17-year-old male enrollee has requested reimbursement for Prometheus Anser IFX testing performed on 6/30/14. 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 the Anser IFX test was ordered to determine the drug concentration for Remicade at the end of induction. This is not standard in the management of ulcerative colitis. The use of Prometheus Anser IFX testing to direct subsequent management has not been clinically proven to improve patient clinical outcomes or alter patient management in controlled clinical trials. The presence of antibodies alone does not necessarily result in loss of response to infliximab, nor have threshold drug levels been established. Studies have found that anti-infliximab antibodies can be transient, and disappear over time, with many patients who have these antibodies maintaining their response. Although loss of response to infliximab is common, there were no standard guidelines defining a therapeutic strategy at the time of testing. Per the current medical evidence, Prometheus Anser IFX testing performed on 6/30/14 was not likely to have been of greater benefit than other modalities. 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 44-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 3/18/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 3
A 44-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 3/18/16. 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 that there is sufficient support for digital breast tomosynthesis for the evaluation of patients for breast cancer screening. Digital breast tomosynthesis provides advantages to radiologists interpreting mammograms. This tomographic method often enables the reader to separate dense glandular elements from underlying mass/architectural distortion, resulting in a decrease in callbacks, increase in accuracy and increase in detection of small cancers. For this reason, the addition of digital breast tomosynthesis to the usual two dimensional protocol was likely of greater benefit to the patient than had the examination been performed using two dimensional imaging alone. 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 |
The patient is a 17-year-old female who reports back pain that worsens with exercise. The patients parent has requested authorization and coverage for breast reduction surgery. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient and are not reconstructive in nature.
fold, difficulty in performing daily activities, paresthesia in the hands (due to weight on the anterior chest wall and compression of the brachial plexus),
the weight of the breasts being transferred to the shoulder strap area; headache and congenital breast deformity. This patient complains of back pain.
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is a 17-year-old female who reports back pain that worsens with exercise. The patients parent has requested authorization and coverage for breast reduction surgery. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient and are not reconstructive in nature. This denial is the subject of this appeal and determination. The physician reviewer found that Cabral and colleagues stated, Women with increased breast size experience symptoms such as pain in the neck, shoulders and lumbar spine, headache, intertrigo in the inframammary fold, difficulty in performing daily activities, paresthesia in the hands (due to weight on the anterior chest wall and compression of the brachial plexus), difficulty in exercising, low self-esteem, and body dissatisfaction. The American Society of Plastic Surgeons states that reduction mammaplasty authorization should be based on documentation of the severity of the symptoms of macromastia and impact on health-related quality of life with at least two of the following signs: chronic breast pain due to weight of the breasts; intertrigo unresponsive to medical management; upper back, neck, and shoulder pain; backache, unspecified; thoracic kyphosis, acquired; shoulder grooving from bra straps; upper extremity paresthesia due to brachial plexus compression syndrome secondary to the weight of the breasts being transferred to the shoulder strap area; headache and congenital breast deformity. This patient complains of back pain. Shoulder grooving is not reported on physical examination or documented on photographs received for review. There is no report of chronic breast pain due to weight of the breasts, intertrigo unresponsive to medical management, thoracic kyphosis, upper extremity paresthesia, headache, or congenital breast deformity. Since there are less than two documented quality of life signs, the requested service would be considered not medically necessary according to American Society of Plastic Surgeons criteria. The American Society of Plastic Surgeons has indicated that the decision to perform reduction mammaplasty should be based on patient symptoms and a surgeons assessment of the likelihood of benefit as opposed to the amount (weight) of breast tissue to be removed. It has been indicated by others, however, that the American Society of Plastic Surgeon position is largely based on observational studies, which are un-blinded, lack randomized control groups and have potential for selection bias, and expert opinion. The more common and accepted guidelines use a measurement of body surface area and weight removed to determine medical necessity. The gold standard for this determination is the study by Schnur and colleagues. The article does not establish a defined lower weight for breast resection; it establishes a range. According to the article, 404 grams would be the lower 22nd percentile of weight resection for a BSA of 1.75, with 258 grams being the lower 5th percentile of weight of resection with a BSA of 1.75. According to the article, if the patients data plot is above the 22nd percentile, the motivation is purely medical. If the data plot below the 5th percentile, the motivation is purely cosmetic. If the data plot is between the two lines, the motivation is mixed and must be looked at individually. In this case, the proposed resection of 300 grams per breast is below the 22nd percentile of 404 grams per breast at a BSA of 1.75 and above the 5th percentile of 258 grams per breast at a BSA of 1.75. This would qualify the motivation as mixed according to weight. Combining this mixed determination of medical necessity based on weight with the lack of determination of medical necessity based on American Society of Plastic Surgeons criteria, the requested service of bilateral reduction mammaplasty is not medically necessary for the treatment of this patient. The California Reconstructive Surgery statute requires health insurers to cover reconstructive surgeries, defined as surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) To improve function. (2) To create a normal appearance, to the extent possible. This patient has large breasts which are ptotic. The appearance of the breasts is within the wide range of normal for female breasts. Breasts within the wide range of normal are not abnormal structures of the body. The California Reconstructive Surgery Statute does not apply to this patient.
| 1 |
The patient is a 62-year-old male with a T1c Gleason 3+3 prostate cancer. His tumor was sent for OncotypeDX Prostate Cancer on 2/14/17 to help guide treatment decision making. The Health Insurer has denied this request indicating that the services at issue were considered investigational for the evaluation of the patients prostate cancer. The patient has requested reimbursement for the gene expression profiling OncotypeDX prostate cancer assay performed on 2/14/17. The Health Insurer has denied this request on the basis that the services at issue were investigational for the evaluation of this patients medical condition.
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Overturned
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Experimental
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Summary Reviewer 2
The patient is a 62-year-old male with a T1c Gleason 3+3 prostate cancer. His tumor was sent for OncotypeDX Prostate Cancer on 2/14/17 to help guide treatment decision making. The Health Insurer has denied this request indicating that the services at issue were considered investigational for the evaluation of the patients prostate cancer. The patient has requested reimbursement for the gene expression profiling OncotypeDX prostate cancer assay performed on 2/14/17. The Health Insurer has denied this request on the basis that the services at issue were investigational for the evaluation of this patients medical condition. The National Comprehensive Cancer Network (NCCN) recommends testing with OncotypeDX post biopsy for NCCN very low and low risk prostate cancer in patients with at least 10 years life expectancy who have not received treatment for prostate cancer and are candidates for active surveillance or definitive therapy. Men with clinically localized disease may consider the use of tumor based molecular assays. Retrospective case cohort studies have shown that molecular assays performed on biopsy or prostatectomy specimens provide prognostic information independent of NCCN risk groups. These include, but are not limited to, likelihood of death with conservative management, likelihood of biochemical progression after radical prostatectomy or external beam therapy, and likelihood of developing metastasis after radical prostatectomy or salvage radiotherapy. The OncotypeDX assay is considered standard of care in guiding treatment decision making for patients with low risk prostate cancer. Accordingly, the gene expression profiling OncotypeDX prostate cancer assay performed on 2/14/17 was likely to have been more beneficial than any available standard therapy for the evaluation of this patients medical condition. Therefore, for the reasons stated above, the services at issue were likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
The parent of a 16-year-old male enrollee has requested reimbursement for the comparative genomic hybridization (CGH) testing performed on 4/26/16. The Health Plan has denied this request indicating that the testing at issue was considered investigational for the enrollees dysmorphic facies and postural and kinetic tremor.
. The clinic notes report that he has anxiety and depression with hallucinations, tremor, and differences in sensation. The notes
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Overturned
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Experimental
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Summary Reviewer 3
The parent of a 16-year-old male enrollee has requested reimbursement for the comparative genomic hybridization (CGH) testing performed on 4/26/16. The Health Plan has denied this request indicating that the testing at issue was considered investigational for the enrollees dysmorphic facies and postural and kinetic tremor. The physician reviewer found thatCGH, also known as chromosomal microarray (CMA), is recommended by the American College of Medical Genetics (ACMG) as a first-tier test for patients with autism spectrum disorders or developmental delay and intellectual disability. The yield of CMA in patients with these disorders is estimated to be around 10%. However, there is no indication that this patient has these conditions. The clinic notes report that he has anxiety and depression with hallucinations, tremor, and differences in sensation. The notes also mention mild dysmorphic features, however these were not specified. In this clinical setting, the yield of CMA is likely to be low for this patient. As such, the CGH testing performed on 4/26/16, 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.
| 1 |
A 63-year-old male enrollee has requested authorization and coverage for implantation of cranial nerve stimulator. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollee who has been diagnosed with acute obstructive sleep apnea. The physician reviewer found that the patient is a 63-year-old male who has a history of obstructive sleep apnea (OSA) and poor sleep. He is status post palate surgery and septoplasty. He underwent sleep endoscopy which revealed antero-posterior collapse at the velum and base of tongue. His Epworth sleepiness scale was reported at 4/24. He had a body mass index (BMI) of 34.6 when he underwent a polysomnography in 2013. That study also revealed an apnea-hypopnea index (AHI) score of 56.5. On 11/24/15, another sleep study was performed. The patients AHI score was document at 34.5. He failed continuous positive airway pressure (CPAP) therapy and was treated with bilevel therapy. The treating provider discussed implantation with cranial nerve stimulator as an option for treatment. The patient requests authorization and coverage for implantation of cranial nerve stimulator. The Health Insurer denied this request as investigational for treatment of this patients medical condition.
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Upheld
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Experimental
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Summary Reviewer 3
A 63-year-old male enrollee has requested authorization and coverage for implantation of cranial nerve stimulator. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollee who has been diagnosed with acute obstructive sleep apnea. The physician reviewer found that the patient is a 63-year-old male who has a history of obstructive sleep apnea (OSA) and poor sleep. He is status post palate surgery and septoplasty. He underwent sleep endoscopy which revealed antero-posterior collapse at the velum and base of tongue. His Epworth sleepiness scale was reported at 4/24. He had a body mass index (BMI) of 34.6 when he underwent a polysomnography in 2013. That study also revealed an apnea-hypopnea index (AHI) score of 56.5. On 11/24/15, another sleep study was performed. The patients AHI score was document at 34.5. He failed continuous positive airway pressure (CPAP) therapy and was treated with bilevel therapy. The treating provider discussed implantation with cranial nerve stimulator as an option for treatment. The patient requests authorization and coverage for implantation of cranial nerve stimulator. The Health Insurer denied this request as investigational for treatment of this patients medical condition. OSA is an increasingly prevalent clinical problem with significant effects on both personal and public health. CPAP has demonstrated excellent efficacy and low morbidity with long-term adherence rates approaching 50%. Although traditional upper airway surgical procedures target the anatomic component of obstruction, upper airway stimulation tackles the twin goals of improving anatomic and neuromuscular pathology. The STAR trial demonstrated that cranial nerve stimulation led to significant improvements in objective and subjective measurements of the severity of OSA (Woodson, et al). However, these studies were performed in a subset of patients with OSA. Patients with concentric airway collapse, BMI greater than 32 and AHI less than 20 or greater than 50 were excluded. In this patients case, his BMI was 34.6 and his recent AHI was 34.5. All told, in this patients case, the current medical evidence does not support the superiority of implantation of cranial nerve stimulator over the available standard 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 60-year-old female enrollee has requested authorization and coverage for a heart monitor (implantable ambulatory event monitor). The Health Plan has denied this request indicating that the requested device is considered investigational for treatment of the enrollees syncopal episodes.
. In this case, the patient has syncope with head trauma and previous evaluation has not determined the cause of syncope. The patients symptoms are described as infrequent and the extensive work-up was performed years.
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Overturned
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Experimental
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Summary Reviewer 3
A 60-year-old female enrollee has requested authorization and coverage for a heart monitor (implantable ambulatory event monitor). The Health Plan has denied this request indicating that the requested device is considered investigational for treatment of the enrollees syncopal episodes. The physician reviewer found the request for a heart monitor (implantable ambulatory event monitor) is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The ILR is a non-invasive diagnostic device that is often of great clinical use in this clinical setting, since it can remain in place for long periods of time and provide information about arrhythmias when other techniques have not been revealing. In this case, the patient has syncope with head trauma and previous evaluation has not determined the cause of syncope. The patients symptoms are described as infrequent and the extensive work-up was performed years. The requested device is likely to provide better information than a 30-day monitor or any other type of monitor currently available. Moreover, the use of the ILR is in accordance with American College of Cardiology guidelines. For the reasons provided, the requested device 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 device is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 40-year-old male enrollee has requested reimbursement for acupuncture services (CPT code 97810) provided from 8/13/15 through 10/31/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees abdominal pain.
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Upheld
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Experimental
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Summary Reviewer 1
A 40-year-old male enrollee has requested reimbursement for acupuncture services (CPT code 97810) provided from 8/13/15 through 10/31/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees abdominal pain. The physician reviewer found the acupuncture services (CPT code 97810) provided from 8/13/15 through 10/31/15 were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. There is a lack of peer-reviewed medical literature supporting acupuncture as more beneficial than standard therapy. Li and colleagues reviewed the efficacy of acupuncture as a treatment for gastrointestinal (GI) dysfunction and the associated underlying mechanisms. The authors concluded that further studies are needed to investigate the effects and more systematic mechanisms in treating GI dysfunction, and to promote the application of acupuncture for the treatment of GI diseases. In addition, the documentation provided for review does not show the patients pre- and post-care condition to compare the functional gains and medication intake reduction obtained with the acupuncture performed. Accordingly, the services at issue were 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 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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A 70-year-old male enrollee has requested reimbursement for service code 97139, unlisted therapeutic procedure, performed on 4/20/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrolleeas medical condition.
the patient received this service, the service involves a patient being secured to a thoracic harness and a pelvic harness, with tension then applied. The patient in this case received 50 lbs of tension for 25 minutes on his earlier visits, and this was gradually increased to 100 lbs of tension for 25 minutes by mid/late June 2020.
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Upheld
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Experimental
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Summary Reviewer 1
A 70-year-old male enrollee has requested reimbursement for service code 97139, unlisted therapeutic procedure, performed on 4/20/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that the specifics of how the service in question is physically administered upon patients are not described in the medical literature. There is no clear description of the technique on the serviceas website. The website makes no reference to any published, peer-reviewed, medical, scientific or clinical studies involving this service specifically. The technical features of this service appear proprietary. As best as can be discerned from the records provided by the facility where the patient received this service, the service involves a patient being secured to a thoracic harness and a pelvic harness, with tension then applied. The patient in this case received 50 lbs of tension for 25 minutes on his earlier visits, and this was gradually increased to 100 lbs of tension for 25 minutes by mid/late June 2020. The service in question, overall, appears to be a lumbar traction table, likely provided in an intermittent/cyclical manner, and marketed in a manner to suggest that exposure to this device improves an intervertebral discas health or anutrition.a
There is no reasonable expectation that exposure to the service in question will provide any health or functional benefits that would be different to exposure to other types of lumbar traction devices. This is to say that no health or functional benefits would be expected from exposure to this specific device. The intervertebral discs are routinely offloaded from pressure in the recumbent position (e.g., during sleep). There is no proven clinical benefit of providing exogenously applied force aimed at distraction of the discs, whether continuously or rhythmically. The literature, overall, does not support the use of lumbar traction for back pain conditions attributed to disc degeneration or pathology. The support for the use of this type of intervention is anecdotal. The focus of treatment of benign, musculoskeletal/mechanical low back pain includes patient education (particularly with respect to the natural history of the condition), independently applied topical modalities for palliation, common analgesics for palliation, if warranted, exercise and remaining active. The service in question was not likely to have been more beneficial for treatment of the patientas condition than routine management involving the above. There are no simple, proven interventions (including lumbar traction) that provide marginally superior benefits than the above. Therefore, the unlisted therapeutic procedure provided on 4/20/20 was not likely to have been more beneficial than any available standard therapy.
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The patient is a 56-year-old female with osteoporosis. Her provider has prescribed Prolia for the treatment of this condition. The patient has requested authorization and coverage for Prolia 60 mg injected every six months for one year. The physician
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 56-year-old female with osteoporosis. Her provider has prescribed Prolia for the treatment of this condition. The patient has requested authorization and coverage for Prolia 60 mg injected every six months for one year. The physician reviewer found that the patient has been diagnosed with osteoporosis. Four agents (alendronate, risedronate, zoledronic acid and denosumab) have evidence for broad spectrum anti-fracture efficacy and should generally be considered as initial options for most patients who are candidates for treatment. There is a lack of head-to-head trials with a preplanned endpoints of fractures comparing one drug with another. Bisphosphonates (alendronate, risedronate and zoledronic acid) are usually the first-line of therapy. Prolia (denosumab) has been approved by the U.S. Food and Drug Administration for the treatment of osteoporosis in postmenopausal women at high-risk of fracture. Denosumab reduces the incidence of vertebral fractures by about 68%, hip fractures by about 40% and nonvertebral fractures by about 20% over three years. Per the medical evidence, Prolia is likely to be effective in treating the patients osteoporosis and in decreasing the risk of bone fracture. Therefore, Prolia 60 mg injected every six months for one year is medically necessary for the treatment of this patient.
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A 29-year-old female enrollee has requested authorization and coverage for compound medication of sirolimus cream 1%. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollee, who has Klippel Trenaunay syndrome.
has been receiving. She has already been treated with laser and surgery and is still developing new blebs, placing her at risk for bleeding and infection.
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Overturned
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Experimental
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Summary Reviewer 1
A 29-year-old female enrollee has requested authorization and coverage for compound medication of sirolimus cream 1%. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollee, who has Klippel Trenaunay syndrome. The physician reviewer found that the treatment of rare vascular malformations is multidisciplinary, as this patient has been receiving. She has already been treated with laser and surgery and is still developing new blebs, placing her at risk for bleeding and infection. There is a lack of standard therapies for this disease. The use of topical sirolimus is likely to be more beneficial for the patient than the previous treatments she has tried. Promising results have been reported in preliminary studies. Therefore, compound medication of sirolimus cream 1% is likely to be of greater benefit than other available treatment options. 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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A 35-year-old female enrollee has requested reimbursement for BRCA1, BRCA2 (breast cancer 1 and 2) (hereditary breast and ovarian cancer) gene analysis, full sequence analysis and common duplication/d
in BRCA1 performed on 12/07/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition.
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Upheld
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Medical Necessity
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Summary Reviewer
A 35-year-old female enrollee has requested reimbursement for BRCA1, BRCA2 (breast cancer 1 and 2) (hereditary breast and ovarian cancer) gene analysis, full sequence analysis and common duplication/deletion variants in BRCA1 performed on 12/07/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that the submitted documentation does not support the medical necessity of the services at issue. While the lifetime risk score completed by Myriad MyRisk was estimated to be 29.6%, higher than the 20% lifetime risk considered threshold for changes in management, this indicates that the patient should be considered for earlier or increased breast screening, not necessarily that genetic testing of BRCA1 and BRCA2 were indicated. Genetic testing for hereditary cancer predisposition syndromes are most useful in individuals who have a personal history of cancer or in those who have affected family members with known mutations. In this patients case, negative BRCA1 and BRCA2 testing did not reduce her risk, as the records do not document the cause of cancer in any of her family members, particularly in the paternal aunt, who is the only relative with cancer at a young age. The current medical evidence does not support the services at issue in this clinical setting. Therefore, BRCA1, BRCA2 (breast cancer 1 and 2) (hereditary breast and ovarian cancer) gene analysis, full sequence analysis and common duplication/deletion variants in BRCA1 performed on 12/07/18 were not medically necessary for the evaluation of this patient.
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A 63-year-old female enrollee has requested reimbursement and prospective authorization and coverage for physical therapy provided from 8/17/15 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees medical condition.
, the patient had post-operative disability after foot surgery and physical therapy was prescribed to improve function. The patient made improvement in physical therapy through 8/19/15.
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Overturned
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Medical Necessity
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Summary Reviewer
A 63-year-old female enrollee has requested reimbursement and prospective authorization and coverage for physical therapy provided from 8/17/15 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees medical condition. The physician reviewer found according to the documentation submitted for review, the patient had post-operative disability after foot surgery and physical therapy was prescribed to improve function. The patient made improvement in physical therapy through 8/19/15. On that date further physical therapy was reasonable and medically necessary because the patient had continued deficits that are generally amenable to the care of a skilled physical therapist. Based on improvement up to 8/19/15, further improvement could be expected with skilled services. However, the patient did not show further improvement. As such, six additional physical therapy sessions after 8/19/15 were sufficient to show a plateau. After these six sessions, the patient could have been managed with a home exercise program. For the reasons provided, a portion of the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be partially overturned.
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A 54-year-old female has requested reimbursement for chemotherapy treatment provided from 10/06/17 through 12/13/17. The Health Insurer has denied this request indicating that the medication regimen at issue was considered investigational for treatment of the enrollees gallbladder cancer.
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Upheld
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Experimental
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Summary Reviewer 1
A 54-year-old female has requested reimbursement for chemotherapy treatment provided from 10/06/17 through 12/13/17. The Health Insurer has denied this request indicating that the medication regimen at issue was considered investigational for treatment of the enrollees gallbladder cancer. The physician reviewer found that FOLFIRI regimen (without bevacizumab) has an acceptable toxicity profile and a good activity, mainly in the second-line treatment. Improved overall survival and progression-free survival were found in patients who achieved partial response or stable disease. Hence, this regimen is considered standard. However, there is a lack of support for FOLFIRI with Avastin. This combination has not been tested in a randomized clinical trial showing a survival benefit. A number of phase II studies have been published showing safety only. Efficacy as measured by overall survival and progression-free survival has not been demonstrated with this combination. Therefore, the superior efficacy of the chemotherapy treatment provided from 10/06/17 through 12/13/17 has not been established. Based upon the information set forth above, the medication regimen at issue was 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 five-year-old female enrollee has requested authorization and coverage for genetic testing. The Health Insurer has denied this request indicating that the requested testing is not medically necessary for evaluation of the enrollees developmental delay.
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Overturned
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Medical Necessity
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Summary Reviewer
The parent of a five-year-old female enrollee has requested authorization and coverage for genetic testing. The Health Insurer has denied this request indicating that the requested testing is not medically necessary for evaluation of the enrollees developmental delay. The physician reviewer found that based on the medical literature and the presented clinical records submitted for review, the request for genetic testing is medically necessary for evaluation of the patients medical condition. The clinical utility of CMA is well established in the peer-reviewed literature and is considered a first-line genetic test for patients with developmental delays and autism spectrum disorders according to the American Academy of Pediatrics (AAP), the American College of Medical Genetics (ACMG), the American College of Neurology (AAN) and the Child Neurology Society (CNS) (Schaefer, et al; Moeschler, et al; Shevell, et al; Shen, et al). CMA technology has been shown to provide clinically actionable information. The study by Coulter and colleagues demonstrated that CMA results influenced medical care by in the majority of patients by precipitating medical referrals, diagnostic imaging, and specific laboratory testing supporting the use of CMA as a clinically useful diagnostic test. Current data suggest that many clinically significant genetic changes can impact neurodevelopment without associated anatomic departures. For the reasons provided, the request for genetic testing has been established as medically necessary for evaluation of the patients medical condition. Therefore, the requested testing is medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be overturned.
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A 50-year-old male enrollee has requested reimbursement for the DecisionDx melanoma assay provided on 8/19/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees thin melanoma.
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Upheld
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Experimental
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Summary Reviewer 2
A 50-year-old male enrollee has requested reimbursement for the DecisionDx melanoma assay provided on 8/19/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees thin melanoma. The physician reviewer found that the DecisionDx melanoma gene testing has been developed to assess risk of melanoma metastasis in the next five years. The National Comprehensive Cancer Network (NCCN) guidelines state that genetic tests such as the DecisionDx, should not be used outside of the clinical trial setting. Consequently, the DecisionDx melanoma assay is not considered within the standard of care. Accordingly, the DecisionDx melanoma assay provided on 8/19/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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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 this patient was status post incision and drainage of an abscess of the olecranon. The provider has requested procalcitonin in addition to the complete blood count, sedimentation rate, and C-reactive protein to differentiate between inflammatory response and infection.
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Upheld
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Experimental
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Summary Reviewer 2
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 this patient was status post incision and drainage of an abscess of the olecranon. The provider has requested procalcitonin in addition to the complete blood count, sedimentation rate, and C-reactive protein to differentiate between inflammatory response and infection. A review of the literature indicates that there is no specific advantage to using procalcitonin for this purpose. According to Mandell and colleagues, procalcitonin levels were higher in children with documented confirmed bacterial infection as compared with those with no suspicion of infection. However, the authors noted that neither single nor serial procalcitonin measurements were able to predict the presence or absence of confirmed bacterial infection with enough certainty to be clinically useful as to recommend initiating or withholding antibiotics. Therefore, the superior effectiveness of procalcitonin testing 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.
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A 41-year-old male enrollee has requested authorization and coverage for CPT 43284 (laparoscopy, surgical, esophageal sphincter augmentation procedure). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 3
A 41-year-old male enrollee has requested authorization and coverage for CPT 43284 (laparoscopy, surgical, esophageal sphincter augmentation procedure). 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 there is a lack of randomized controlled trials with long-term follow-up demonstrating that LINX is safer or more effective than Nissen fundoplication or other surgical anti-reflux procedures. Per Katz and colleagues, American College of Gastroenterology guidelines for the management of reflux disease also state that more evidence is needed before LINX can be recommended. Skubleny and colleagues concluded, Long-term comparative outcome data past one year are needed in order to further understand the efficacy of magnetic sphincter augmentation. Additionally, LINX (more than surgical fundoplication) is associated with severe dysphagia requiring endoscopic intervention. Sheu and Rattner concluded, The long-term safety and efficacy of LINX, both alone and in comparison to current gastroesophageal reflux disease therapies, remains to be determined. The currently available peer-reviewed literature does not definitively support the conclusion that LINX is more likely to be beneficial in this case than standard treatment, surgical fundoplication. Thus, CPT 43284 (laparoscopy, surgical, esophageal sphincter augmentation procedure) is not likely to be more beneficial than other available treatment options.
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patient is a 73-year-old male with a history of severe aortic stenosis. The patient was referred for transcatheter aortic valve replacement treatment.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 73-year-old male with a history of severe aortic stenosis. The patient was referred for transcatheter aortic valve replacement treatment. The U.S. Food and Drug Administration has expanded the indications for transcatheter aortic valve replacement to include patients at lower risk for aortic valve surgery who meet clinical criteria for aortic valve replacement. In this case, transcatheter aortic valve replacement plus a two day hospital stay is medically necessary for the treatment of this patient.
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The parent of a 15-year-old female enrollee has requested reimbursement for mental health inpatient treatment services provided from 8/25/16 through 8/26/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees eating disorder.
In records dated 8/25/16, the patients weight was 141.2 pounds and 117.7% of her ideal body weight and she was compliant with her meal plan.
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Upheld
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Medical Necessity
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Summary Reviewer
The parent of a 15-year-old female enrollee has requested reimbursement for mental health inpatient treatment services provided from 8/25/16 through 8/26/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees eating disorder. The physician reviewer found that applying the guidelines from the American Psychiatric Association (APA), the mental health inpatient treatment services provided from 8/25/16 through 8/26/16 were not medically necessary for treatment of this patients eating disorder. In records dated 8/25/16, the patients weight was 141.2 pounds and 117.7% of her ideal body weight and she was compliant with her meal plan. Thus, the patient did not require 24-hour supervision in a highly restricted setting in a mental health treatment environment to manage her anorexia and depression safely and adequately. All told, the mental health inpatient treatment services provided from 8/25/16 through 8/26/16 were not medically necessary. 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.
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This patient is a 24-year-old female who was admitted for detoxification services on 5/23/20 after a heroin overdose. The patient has requested reimbursement for substance abuse residential treatment provided from 6/02/20 through 6/20/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient.
I, acute intoxication of withdrawal potential, the patient was initially admitted to detoxification services and managed for withdrawal. She had Clinical Institute Withdrawal Assessment (CIWA) scores ranging from 7 to 15 after moving to the residential treatment center. Thus, her withdrawal needs could have been
has been diagnosed with bipolar disorder. She was noted to have hallucinations and delusional thinking while in the residential treatment center that affected her insight into her condition. She also was noted to be impulsive and needed frequent boundary setting. Although this patientas mental status permitted participation in the residential treatment program, the records noted significant functional deficits that were
to change, the patient was noted to be in the contemplative stage of change. She had experienced
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Overturned
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Medical Necessity
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Summary Reviewer
This patient is a 24-year-old female who was admitted for detoxification services on 5/23/20 after a heroin overdose. The patient has requested reimbursement for substance abuse residential treatment provided from 6/02/20 through 6/20/20. 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 physician reviewer found that per the American Society of Addiction Medicine (ASAM) criteria, this patient met Level 3.5 criteria for residential treatment services provided from 6/2/20 through 6/20/20. ASAM criteria focuses on six dimensions to determine the appropriate level of care. With regard to dimension I, acute intoxication of withdrawal potential, the patient was initially admitted to detoxification services and managed for withdrawal. She had Clinical Institute Withdrawal Assessment (CIWA) scores ranging from 7 to 15 after moving to the residential treatment center. Thus, her withdrawal needs could have been managed in Level 3.5 setting. In terms of dimension II, biomedical conditions, this patient did not have any identified medical problems. With regard to dimension III, emotional, behavioral, or cognitive conditions, the patient has been diagnosed with bipolar disorder. She was noted to have hallucinations and delusional thinking while in the residential treatment center that affected her insight into her condition. She also was noted to be impulsive and needed frequent boundary setting. Although this patientas mental status permitted participation in the residential treatment program, the records noted significant functional deficits that were sufficiently severe that she was not likely to maintain mental stability or abstinence if treatment was not provided in a non-residential setting. In terms of dimension IV, readiness to change, the patient was noted to be in the contemplative stage of change. She had experienced persistent psychotic symptoms and significant overdosage as serious consequences. She was noted to blame relationships and others for her ongoing usage. Thus, despite experiencing serious consequences, the patient had marked difficulty in understanding the relationship between substance use and her impaired coping skills and level of functioning, often blaming others for her addiction problems. With regard to dimension V, relapse, continued use, or continued problem potential, the patient did not recognize relapse triggers and lacked insight into benefits of continuing care. In terms of dimension VI, recovery environment, the patientas social network included regular users of drugs such that recovery goals are assessed as unachievable at a less intensive level of care. In sum, the submitted records support the medical necessity of the services at issue. Therefore, substance abuse residential treatment provided from 6/02/20 through 6/20/20 was medically necessary for the treatment of this patient.
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A 46-year-old female enrollee has requested reimbursement for Afirma Gene Expression Classifier testing performed on 9/6/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees thyroid nodule.T
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Overturned
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Experimental
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Summary Reviewer 3
A 46-year-old female enrollee has requested reimbursement for Afirma Gene Expression Classifier testing performed on 9/6/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees thyroid nodule.The physician reviewer found the American Thyroid Associations guidelines state that for follicular neoplasm nodules, molecular testing may be used to supplement malignancy risk assessment data in lieu of proceeding directly with surgery. In this case, the cytopathology of the 3.4 cm thyroid nodule was consistent with a follicular neoplasm. The risk of malignancy is 15-30% in follicular neoplasm nodules (Cibas, et al; Haugen, et al). The result of the gene expression classifier was benign, which may prevent unnecessary surgery. In addition, there are multiple peer-reviewed scientific articles supporting the benefit of genetic testing in thyroid nodules (Haugen, et al; Alexander, et al). Therefore, the Afirma Gene Expression Classifier testing performed on 9/6/16 was likely to be more beneficial for the evaluation of the patients medical condition than other 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 49-year-old male enrollee has requested reimbursement for Oncotype DX Colon Cancer Assay performed on 5/29/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 3
A 49-year-old male enrollee has requested reimbursement for Oncotype DX Colon Cancer Assay performed on 5/29/14. 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 the medical evidence shows that adjuvant chemotherapy confers a survival advantage for patients with stage III colorectal cancer, but not for those with stage II disease. The reasons for this conclusion are complex. Stage II patients do well after surgery alone so that the magnitude of the survival benefit conferred by adjuvant chemotherapy is small; and, randomized clinical trials to date have had too few stage II patients to discern a statistically significant advantage. Therefore, subset analyses to identify those patients with prognostic features that may predict for chemotherapy benefit have been analyzed. For example, oncologists consider adjuvant treatment for those stage II patients with T4 disease, obstructing lesions, and other biomarkers. The Oncotype DX test uses a reverse transcriptase-polymerase chain reaction assay for 12 genes in an algorithm that can be used to predict recurrence. The test was validated independently as being an excellent prognostic indicator. It remains an open question whether adjuvant chemotherapy can obviate recurrence risk. Nevertheless, the medical evidence for the test is sufficient to allow its use to estimate the risk of recurrence for stage II patients and incorporated with other tests such as standard pathology and microsatellite instability testing. Thus, Oncotype DX Colon Cancer Assay performed on 5/29/14 was likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 33-year-old female enrollee has requested reimbursement for the Anser IFX testing performed on 2/18/16. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees small bowel Crohns disease.
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Upheld
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Experimental
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Summary Reviewer 2
A 33-year-old female enrollee has requested reimbursement for the Anser IFX testing performed on 2/18/16. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees small bowel Crohns disease. The physician reviewer found in this case, Anser IFX was ordered to determine infliximab level and whether antibodies to infliximab were present. The use of Anser IFX to direct management has not been clinically proven to improve patient clinical outcomes or alter patient management in controlled clinical trials of patients with Crohns disease. The presence of antibodies alone does not necessarily result in loss of response to infliximab, nor have clear infliximab levels been established (Steenholdt, et al). Studies have found that anti-infliximab antibodies can be transient, and disappear over time, with many patients who have these antibodies maintaining their response (Vande Casteele, et al; Nanda, et al). A recent study concluded that prospective evaluation of the value of measuring serum concentrations of infliximab should be performed before these data can be included in patient management strategies (Adedokun, et al). One study, with some patients undergoing dose intensification following initial non-response, showed no difference in serum levels of infliximab between patients who responded to dose intensification versus those who did not (Pariente, et al). Although loss of response to infliximab is common, there were no standard guidelines defining a therapeutic strategy at the time of testing (Vande Casteele, et al). A systematic review reported that future prospective controlled studies are needed, especially considering that anti-tumor necrosis factor (TNF) levels are influenced by several variables that can fluctuate over time and among individuals (Yarur, et al). For these reasons, the Anser IFX testing performed on 2/18/16 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 29-year-old female enrollee has requested authorization and coverage for lumbar spine magnetic resonance imaging. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the evaluation of the enrollees medical condition.
This patient has a progressive problem related to her lumbar spine. While she has intact reflexes and no red flags, she has completed a six-week course of physical therapy, and still has symptoms. Because her symptoms have worsened since her MRI in 2010 and she has completed a
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Overturned
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Medical Necessity
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Summary Reviewer
A 29-year-old female enrollee has requested authorization and coverage for lumbar spine magnetic resonance imaging. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the medical necessity of the requested services. This patient has a progressive problem related to her lumbar spine. While she has intact reflexes and no red flags, she has completed a six-week course of physical therapy, and still has symptoms. Because her symptoms have worsened since her MRI in 2010 and she has completed a supervised six-week course of physical therapy in June and July 2019 without relief, MRI of the lumbar spine is medically appropriate. Therefore, the requested lumbar spine MRI is medically necessary for the evaluation of this patient.
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The patient is 61-year-old male who presented for a neurology consultation on 10/21/16 for chief complaints of snoring and fatigue. The patient endorsed snoring, non-restorative sleep and daytime sleepiness. He endorsed a past history of (nocturnal) teeth grinding. The patient was reportedly previously diagnosed with obstructive sleep apnea (OSA) but was unable to tolerate continuous positive airway pressure therapy (CPAP). The patient reported a history of seizures, which were characterized as lapses. He was on Keppra extended release for this condition. Physical examination showed the patient to be 69 inches tall and weighed 181 pounds. Physical examination was said to show a beefy tongue and narrow inlets in the nose. The provider listed a primary diagnosis of sleep apnea. The patient was referred for split night polysomnography. On 11/1/16, the patient reportedly underwent a split night study where the patients apnea hypopnea index was 1.2 events per hour. The recording technologist initiated CPAP during the study. The final report stated that CPAP was applied but that the patient was unable to tolerate CPAP. The patient has requested reimbursement for in-laboratory sleep study performed on 11/1/16. The Health Insurer denied reimbursement and reported that the services at issue were not medically
In this case, the patient presented with a clinical presentation that was suggestive of a sleep related breathing disorder. He was noted to have had a prior diagnosis of OSA. He endorsed snoring and non-restorative sleep. He also had a history of gastroesophageal reflux
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is 61-year-old male who presented for a neurology consultation on 10/21/16 for chief complaints of snoring and fatigue. The patient endorsed snoring, non-restorative sleep and daytime sleepiness. He endorsed a past history of (nocturnal) teeth grinding. The patient was reportedly previously diagnosed with obstructive sleep apnea (OSA) but was unable to tolerate continuous positive airway pressure therapy (CPAP). The patient reported a history of seizures, which were characterized as lapses. He was on Keppra extended release for this condition. Physical examination showed the patient to be 69 inches tall and weighed 181 pounds. Physical examination was said to show a beefy tongue and narrow inlets in the nose. The provider listed a primary diagnosis of sleep apnea. The patient was referred for split night polysomnography. On 11/1/16, the patient reportedly underwent a split night study where the patients apnea hypopnea index was 1.2 events per hour. The recording technologist initiated CPAP during the study. The final report stated that CPAP was applied but that the patient was unable to tolerate CPAP. The patient has requested reimbursement for in-laboratory sleep study performed on 11/1/16. The Health Insurer denied reimbursement and reported that the services at issue were not medically necessary for the evaluation of this patients sleep disorder. There is a lack of support in the medical literature for the medical necessity of the services at issue in this clinical setting. In this case, the patient presented with a clinical presentation that was suggestive of a sleep related breathing disorder. He was noted to have had a prior diagnosis of OSA. He endorsed snoring and non-restorative sleep. He also had a history of gastroesophageal reflux disease and an enlarged tongue. These are all potential signs of OSA (Jordan, et al; Epstein, et al 2016). Given the prior diagnosis of OSA and signs and reported symptoms, sleep testing would have been clinically appropriate (Kapur, et al). In this patient, with a reasonably high pre-test probability of OSA particularly given his prior diagnosis, testing could have been performed in the ambulatory or home setting. As noted by Jordan and colleagues, there has been a shift from the attended to the unattended setting for such testing. A recent study by Donovan and colleagues also reported the same shift. While testing was indicated in this patients case, performance of attended sleep testing exceeded this patients clinical and diagnostic needs. In this regard, in-laboratory sleep study performed on 11/1/16 was not medically necessary. Therefore, for the reasons stated above, the services at issue were not medically necessary for the evaluation of the patients medical condition. The Health Insurers denial should be upheld.
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The parent of a 14-year-old male enrollee has requested reimbursement for wilderness treatment therapy provided from 7/16/18 through 8/30/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 3
The parent of a 14-year-old male enrollee has requested reimbursement for wilderness treatment therapy provided from 7/16/18 through 8/30/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition. The physician reviewer found that there is some support for the services at issue in this setting. Behrens and colleagues noted that in a longitudinal outcome study it was shown that youth in the study experienced significant decreases in suicidal ideation, anxiety, depression, substance abuse, social conflict, sleep disruption, violence, as well as an overall reduction in externalizing behaviors such as impulsivity, defiance, and hostility. Furthermore, these youth demonstrated improvements in work and academic functioning during the follow-up portion of the study. DeMille and colleagues noted that, youth participants who attended an outdoor behavioral healthcare treatment program were, as reported by their parents, functioning significantly better than the Treatment as Usual (TAU) group one year following the program as measured by the Youth Outcome Questionnaire 2.01. Youth who remained in their communities were still at acute levels of psychosocial dysfunction during the same time span. Despite some differences between the means of the treatment and TAU groups across time between gender and groups, a regression analysis revealed age and gender not to be significant predictors of improvement. The only significant predictor was participation in the treatment group. In this patients case, wilderness therapy was in accordance with generally accepted standards of medical practice. Therefore, wilderness treatment therapy provided from 7/16/18 through 8/30/18 was likely to have been more beneficial than other treatment options.
| 0 |
A 58-year-old female enrollee has requested authorization and coverage for the LINX device. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD) and esophagitis.
This patient has a hypertensive LES and EGJ outflow obstruction along with a history of a food impaction.
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Upheld
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Experimental
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Summary Reviewer 3
A 58-year-old female enrollee has requested authorization and coverage for the LINX device. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD) and esophagitis. The physician reviewer found that one of the main adverse events related to the placement of a LINX device is dysphagia. When severe, these symptoms could lead to the need to remove the device. This patient has a hypertensive LES and EGJ outflow obstruction along with a history of a food impaction. Therefore, this patient is at markedly increased risk for having dysphagia or future events of food bolus obstruction if the LINX is placed. Additionally, the patients underlying motility disorder is likely contributing to her symptoms as she experiences frequent symptoms 24-hours per day, but only has a borderline positive study for acid reflux. All told, the requested LINX device 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 procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 65-year-old male enrollee has requested authorization and coverage for PET (CPT code 78813) scan. The Health Insurer has denied this request indicating that the requested testing considered investigational for evaluation of the enrollees prostate cancer.
|
Overturned
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Experimental
|
Summary Reviewer 2
A 65-year-old male enrollee has requested authorization and coverage for PET (CPT code 78813) scan. The Health Insurer has denied this request indicating that the requested testing considered investigational for evaluation of the enrollees prostate cancer. The physician reviewer found that there is support for the efficacy of the requested services in this clinical setting. The National Comprehensive Cancer Network (NCCN) guidelines support the use of PET scan in patients diagnosed with recurrent prostate cancer. The studies have shown the safety and efficacy of this technique in patients experiencing biochemical recurrence. Some patients have distant disease detected with this technique sparing patients side effects from treatment. As such, PET (CPT code 78813) scan is likely to be more beneficial than the available standard techniques for the evaluation of this patient. Therefore, for the reasons stated 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.
| 1 |
A 38-year-old male enrollee has requested authorization and coverage for cervical disc prosthesis. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition.
|
Overturned
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Experimental
|
Summary Reviewer 3
A 38-year-old male enrollee has requested authorization and coverage for cervical disc prosthesis. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found the submitted records fail to demonstrate the superior effectiveness of the requested services. There are concerns regarding short-term and long-term potential complications of cervical total disc arthroplasty. The potential long-term complications of cervical total disc arthroplasty include a lack of predictability of individual autoimmune response to metal and methyl methacrylate debris. If revision is needed after total disc arthroplasty, there may be added difficulty when the devices are removed with resultant large defects requiring complex bone graft procedures. Revision procedures will have to be performed through tissue which has undergone a fibrotic response with increased risks incurred during the surgical exposures. This patients relatively young age contributes to an increased likelihood of negative effects and long-term complications. 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.
| 0 |
The patient is a 32-year-old female with excessive daytime sleepiness with Epworth sleepiness score of 18/24. She had a sleep study showing no obstructive sleep apnea followed by a multiple sleep latency test (MSLT) which was consistent with idiopathic hypersomnia with sleep latency less than 8 minutes, but no sleep-onset rapid eye movement (REM). The patient has requested authorization and coverage for Sunosi 75 mg tablets. 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 failed first-line treatment, which is modafinil, and responded to Sunosi
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Overturned
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Medical Necessity
|
Summary Reviewer
The patient is a 32-year-old female with excessive daytime sleepiness with Epworth sleepiness score of 18/24. She had a sleep study showing no obstructive sleep apnea followed by a multiple sleep latency test (MSLT) which was consistent with idiopathic hypersomnia with sleep latency less than 8 minutes, but no sleep-onset rapid eye movement (REM). The patient has requested authorization and coverage for Sunosi 75 mg tablets. 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 Sunosi is a new wake promoting medication that has been approved by the U.S. Food and Drug Administration (FDA) to treat narcolepsy or hypersomnia secondary to residual obstructive sleep apnea. Sunosi is a promising treatment for excessive daytime sleepiness regardless of the cause. Idiopathic hypersomnia is a rare condition. Thus, there is a lack of studies evaluating the effects of Sunosi for the treatment of idiopathic hypersomnia. Sunosi is not contraindicated for idiopathic hypersomnia. Idiopathic hypersomnia shares the same symptoms with narcolepsy type 2, except MSLT shows no sleep-onset REM, which is a narcolepsy characteristic. The requested medication is likely to be as effective for the treatment of idiopathic hypersomnia as treating excessive daytime sleepiness secondary to narcolepsy or obstructive sleep apnea. This patient failed first-line treatment, which is modafinil, and responded to Sunosi 75 mg. There is support for the requested medication in this clinical setting. Therefore, Sunosi 75 mg tablets are medically necessary for the treatment of this patient.
| 1 |
A 22-year-old female enrollee has requested reimbursement for residential mental health treatment services provided from 9/16/15 through 10/16/15. 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.
. Developmentally, the patient had an abysmal sense of self and had failed to achieve the developmental milestone of identity formation. As such, she endured rather chaotic role diffusion manifest by self-defeating cognitive schemas and cyclical maladaptive patterns of behavior.
The patient had failed less restrictive interventions during the episode of illness and was evaluated for suicidality in the acute setting just prior to admission. She was unemployed and not in school. She had poor insight and strained family relations. She did not have a support network conducive to recovery in the outpatient setting. The patient required treatment from behavioral health specialty providers. The patient engaged in active treatment, including dialectical behavior therapy and pharmacotherapy, in structured and supervised setting that forced her to safely confront her distorted cognitions and mal
|
Overturned
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Medical Necessity
|
Summary Reviewer
A 22-year-old female enrollee has requested reimbursement for residential mental health treatment services provided from 9/16/15 through 10/16/15. 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 services in dispute were reasonably expected to improve the patients condition while appropriate care could not have been effectively delivered in a less restrictive setting at the time. Developmentally, the patient had an abysmal sense of self and had failed to achieve the developmental milestone of identity formation. As such, she endured rather chaotic role diffusion manifest by self-defeating cognitive schemas and cyclical maladaptive patterns of behavior. Complicating this underlying foundation was the presence of anxiety and substance use disorders that generated impairment across multiple domains including the areas of occupational, academic, social and family functioning. The patient had failed less restrictive interventions during the episode of illness and was evaluated for suicidality in the acute setting just prior to admission. She was unemployed and not in school. She had poor insight and strained family relations. She did not have a support network conducive to recovery in the outpatient setting. The patient required treatment from behavioral health specialty providers. The patient engaged in active treatment, including dialectical behavior therapy and pharmacotherapy, in structured and supervised setting that forced her to safely confront her distorted cognitions and maladaptive coping skills. Further, both the setting and services were safe, appropriate and consistent with good medical practice, and the duration of care was well within typical community standards. Finally, the disputed service laid the foundation for a successful transition to a community-based after-care program to continue the recovery process. Thus, the services at issue were medically necessary for treatment of the patients medical condition. Therefore, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 68-year-old male enrollee has requested reimbursement for proton beam radiation therapy. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition.
|
Upheld
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Experimental
|
Summary Reviewer 3
A 68-year-old male enrollee has requested reimbursement for proton beam radiation therapy. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition. The physician reviewer found that based on the information submitted, there is a lack of sufficient rationale for the use of proton therapy in the treatment of prostate cancer. Proton therapy is not considered more beneficial than standard conventional radiation therapy in the treatment of prostate cancer. The patients episodic diarrhea in not a sufficient rationale for the use of proton therapy as it is unknown whether treatment with protons or photons would affect this condition. Currently, there is insufficient clinical data to discern whether treatment with proton beam radiation offers a clinical benefit compared to conventional radiation therapy techniques in the treatment of prostate cancer. Sheets and colleagues evaluated the comparative effectiveness of intensity-modulated radiation therapy (IMRT), proton therapy, and conformal radiation therapy for prostate cancer. In the comparison between IMRT and proton therapy, IMRT patients had a lower rate of gastrointestinal morbidity. There were no other significant differences regarding toxicities between IMRT and proton therapy. According to the position statement by The American Society of Radiation Oncology (ASTRO) At the present time, ASTRO believes the comparative efficacy evidence of proton beam therapy with other prostate cancer treatments is still being developed, and thus the role of proton beam therapy for localized prostate cancer within the current availability of treatment options remains unclear. Given the lack of support by national guidelines and peer-reviewed literature, the proton beam radiation therapy was not likely to be more beneficial for treatment than standard photon therapy. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
The patient is a 41-year-old male who sustained a left brachial plexus injury in 2002 and has been noted to have severe distal loss of function despite extensive rehabilitation as well as attempts at surgical reconstruction. A myoelectric orthosis has been proposed in this case. The patient has requested authorization and coverage for a MyoPro device. The Health Insurer has denied this request noting that the requested device is investigational for the treatment of this patient.
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Upheld
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Experimental
|
Summary Reviewer 3
The patient is a 41-year-old male who sustained a left brachial plexus injury in 2002 and has been noted to have severe distal loss of function despite extensive rehabilitation as well as attempts at surgical reconstruction. A myoelectric orthosis has been proposed in this case. The patient has requested authorization and coverage for a MyoPro device. The Health Insurer has denied this request noting that the requested device is investigational for the treatment of this patient. There is very limited support in the literature as to the superior effectiveness of the requested device in this patients case. Although there have been numerous articles in the literature supportive of the potential benefits of this treatment, a recent review by Nadi and Midha discusses the limited available data regarding its effectiveness. The authors conclude that this technology as to its efficacy remains uncertain, Overall, this procedure portends great promise but remains experimental. The future results of the other 11 patients in the study may provide further supporting evidence for the validity of this approach. Conversely, the longer period of follow-up may uncover the downsides of this approach that are still hidden in the shadow of early success. As such, there needs to be further studies before this device can be recommended as a standard option for individuals in this clinical setting. There is still a paucity of evidence in the literature as to its short and long term effectiveness. All told, the requested MyoPro device is not likely to be superior over the standard options available for treating this patients medical condition. Based upon the information set forth above, the requested device is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 22-year-old male enrollee has requested reimbursement for outpatient behavioral health services provided from 1/01/16 through 1/05/16. 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.
On 12/22/15, the patients mood was stable, with no anxiety or depression. He was sleeping well and denied cravings. Therapeutically, he was focused on the conflicted relationship between his mother and grandmother. On 1/01/16, the patient was described as insightful and motivated. He was actively participating in his treatment. His urine drug screen was negative. He was medication adherent, which included quetiapine for insomnia. He had good support from his grandmother. In addition to his relapse prevention efforts, the patient was exploring his characterological organization and consolidating the grief from the death of his stepfather. He was addressing long-term issues, but there was no evidence of an acute psychiatric syndrome,
|
Upheld
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Medical Necessity
|
Summary Reviewer
A 22-year-old male enrollee has requested reimbursement for outpatient behavioral health services provided from 1/01/16 through 1/05/16. 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 fails to demonstrate the medical necessity of the services at issue. On 12/22/15, the patients mood was stable, with no anxiety or depression. He was sleeping well and denied cravings. Therapeutically, he was focused on the conflicted relationship between his mother and grandmother. On 1/01/16, the patient was described as insightful and motivated. He was actively participating in his treatment. His urine drug screen was negative. He was medication adherent, which included quetiapine for insomnia. He had good support from his grandmother. In addition to his relapse prevention efforts, the patient was exploring his characterological organization and consolidating the grief from the death of his stepfather. He was addressing long-term issues, but there was no evidence of an acute psychiatric syndrome, poorly controlled addictive illness or concerning environmental circumstances. Further, the medical records did not include several documents critical to the review process, for example a psychiatric evaluation, psychosocial assessment, multidisciplinary treatment plan or interpretative summary. In the absence of said documents, which typically detail the current status and impact of the illness, analyze the burden of relevant psychosocial stressors, review the outcome of prior interventions and articulate the need for the particular placement, the documentation does not establish that the treatment setting in dispute would have been more likely to improve the patients condition, prevent a more serious episode of illness or reduce morbidity than well-orchestrated community-based programming in a sober living environment. All told, outpatient behavioral health services provided from 1/01/16 through 1/05/16 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.
| 1 |
A 60-year-old female enrollee has requested authorization and coverage for 22870 and 22869 (insertion of stabilization device without compression). 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
that this patient presents with chronic low back pain radiating down the left lower extremity.
standing and walking tolerance. Clinical examination findings document positive straight leg raise, globally limited lower extremity strength, and decreased bilateral lateral leg sensation. There is imaging evidence at both L2/3 and L4/5 of mild disc bulge with mild spinal canal stenosis and no foraminal stenosis. There is imaging evidence of dextroscoliosis curvature centered at L4, which appeared to have increased since the last examination on 8/25/18. There is radiographic evidence of L4/5 anterolisthesis with no instability on flexion/extension x-rays. She has failed conservative treatment.
|
Upheld
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Experimental
|
Summary Reviewer 1
A 60-year-old female enrollee has requested authorization and coverage for 22870 and 22869 (insertion of stabilization device without compression). 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 presents with chronic low back pain radiating down the left lower extremity. Functional limitations are reported in standing and walking tolerance. Clinical examination findings document positive straight leg raise, globally limited lower extremity strength, and decreased bilateral lateral leg sensation. There is imaging evidence at both L2/3 and L4/5 of mild disc bulge with mild spinal canal stenosis and no foraminal stenosis. There is imaging evidence of dextroscoliosis curvature centered at L4, which appeared to have increased since the last examination on 8/25/18. There is radiographic evidence of L4/5 anterolisthesis with no instability on flexion/extension x-rays. She has failed conservative treatment. Under consideration is a request for the Superion device at L4/5, although the requested CPT codes reflect a 2-level procedure. Current peer-reviewed literature does not fully support the spinal decompression device procedure over the gold standard of lumbar laminectomy. There is a lack of large volume, long-term, peer-reviewed outcome studies to support the safety and effectiveness of this device for this patients medical condition as discussed above. There is no compelling rationale presented as to why standard surgical decompression would not be indicated. U.S. Food and Drug Administration (FDA) indications have not been met, as there is no imaging evidence of moderate spinal stenosis. There is no clear evidence that there are no FDA contraindications for the Superion procedure. There is also no documentation of dual-energy x-ray absorptiometry (DEXA) scan findings to rule out osteoporosis, given the history of daily steroid use, which would place her at high-risk. Therefore, the requested CPT codes 22869 and 22870 (insertion of stabilization device without decompression) are not likely to be more beneficial for treatment of the patients medical condition than any standard therapy.
| 1 |
The patient is a 56-year-old male who has been diagnosed with cannabis use disorder, alcohol use disorder, and cocaine use disorder. The patient began smoking marijuana at age 14, drinking alcohol at age 17 and using cocaine at 25 years of age. Prior to admission, the patient was smoking cannabis, drinking 48 ounces of beer and snorting 1 gram of cocaine on a daily basis. The patient was treated previously with chemical dependency outpatient services for two to three weeks in 2016. He also participated in Alcoholics Anonymous and was prescribed escitalopram and amitriptyline. Due to the sequelae of substance use
deceptiveness, isolative behavior and relationship stress, the patient was admitted for detoxification on 1/28/17. He successfully completed a phenobarbital taper and was directly transitioned to a residential treatment program. The Health Insurer has denied reimbursement for inpatient residential treatment from 2/02/17 through 3/08/17. Per the Health Insurer, the services at issue were not medically
Upon admission, the patient had a normal mental status examination. He had no acute psychiatric issues or medical comorbidity aside from hyperlipidemia. He desired balance and happiness. He was employed and valued spirituality. He received his last phenobarbital on 2/01/17, at which time his vital signs were stable, and he had no tremor. Aside from a brief course of outpatient services a year prior, during the episode
|
Upheld
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Medical Necessity
|
Summary Reviewer
The patient is a 56-year-old male who has been diagnosed with cannabis use disorder, alcohol use disorder, and cocaine use disorder. The patient began smoking marijuana at age 14, drinking alcohol at age 17 and using cocaine at 25 years of age. Prior to admission, the patient was smoking cannabis, drinking 48 ounces of beer and snorting 1 gram of cocaine on a daily basis. The patient was treated previously with chemical dependency outpatient services for two to three weeks in 2016. He also participated in Alcoholics Anonymous and was prescribed escitalopram and amitriptyline. Due to the sequelae of substance use including deceptiveness, isolative behavior and relationship stress, the patient was admitted for detoxification on 1/28/17. He successfully completed a phenobarbital taper and was directly transitioned to a residential treatment program. The Health Insurer has denied reimbursement for inpatient residential treatment from 2/02/17 through 3/08/17. Per the Health Insurer, 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 submitted documentation fails to demonstrate the medical necessity of the services at issue. The medical records do not demonstrate the necessity of residential level of care following detoxification. Upon admission, the patient had a normal mental status examination. He had no acute psychiatric issues or medical comorbidity aside from hyperlipidemia. He desired balance and happiness. He was employed and valued spirituality. He received his last phenobarbital on 2/01/17, at which time his vital signs were stable, and he had no tremor. Aside from a brief course of outpatient services a year prior, during the episode of illness the patient had not engaged standard therapies such as anti-craving medications, sober living environments, intensive outpatient programming or partial hospitalization. This is significant because modern psychiatric practice favors treatment in the community as outcome measures and therapeutic gains are optimized in this environment. In sum, the record does not reflect that comprehensive, evidence-based services provided in a less restrictive setting would have been unsafe or inadequate at the time. Thus, inpatient residential treatment from 2/02/17 through 3/08/17 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.
| 1 |
The patient is a 30-year-old male with a history of low back pain and lumbar disc degeneration.
Conservative treatment had included physical therapy, acupuncture, epidural injection, and trigger
point injection. The patient has requested authorization and coverage for lumbar disc replacement
inpatient surgery. 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 30-year-old male with a history of low back pain and lumbar disc degeneration.
Conservative treatment had included physical therapy, acupuncture, epidural injection, and trigger
point injection. The patient has requested authorization and coverage for lumbar disc replacement
inpatient surgery. 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 the U.S. Food and Drug
Administration (FDA) approval for the ProDisc-L total disc replacement states that approval
expands the indications for use of the ProDisc-L to include treatment of up to two consecutive
lumbar spinal sections (levels) from L3-S1. Indications for this device include: patients who are
skeletally mature with no spinal growth remaining; have a condition in which pain is caused by
wear-and-tear on a spinal disc (degenerative disc disease or DDD) at one or two consecutive levels
in the lumbar spine from L3-S1; no more than 25% of the affected vertebral disc that has slipped
forward out of the proper position (grade 1 spondylolisthesis); and have no relief from pain after
at least six months of non-surgical treatment. FDA exclusions include infection at the implant
location or elsewhere; osteopenia or osteoporosis with a T-score (bone density measurement) less
than -1.0; narrowing of the lumbar bones that puts pressure on the spinal cord and nerves (spinal
stenosis); allergy or sensitivity to the implant materials (cobalt, chromium, molybdenum,
polyethylene, titanium); compression syndromes due to herniated disc; stress fracture in the lumbar
spine; affected vertebral endplate that is smaller than 34.5 mm when measured form the middle of
the disc to the side of the disc and/or 27 mm when measured from the front of the disc to the back
of the disc; damage to the affected disc due to current or past damage; and spondylolisthesis that
is greater than Grade 1. Formica and colleagues noted, The optimal surgical indication is crucial
to achieve excellent clinical and radiological outcomes. According to the literature and to our
experience, we underline the importance of a coronal deformity less than 15 degree Cobb angle
and a Roussouly type 1 or 2 as the profile of the most well-suited patient for total disc replacement.
Our long-term results confirm the existing evidence about efficacy and safety of total disc
replacement as a reliable option, in optimal surgery indication, to treat degenerative disc disease.
Yue and colleagues noted, Long-term evidence supports lumbar total disc replacement as safe.
Nie and colleagues performed a meta-analysis to evaluate whether a beneficial clinical effect of
the total disc replacement over lumbar fusion for the treatment of patients with degenerative disc
disease. The authors noted, In a long-term of follow-up (2 years), total disc replacement shows a
significant superiority for the treatment of lumbar degenerative disc disease compared with
fusion. In this case, the patient presented with low back pain that radiates to his gluteal area. He
occasionally also has posterior thigh tightness. The pain is increased with prolonged sitting. His
pain is quite positional. He is able to decrease the pain with walking or standing. However, he
reports working on the computer is difficult due to the pain. Examination revealed lumbar full
range of motion. There is intact strength and sensation. However, detailed documentation is not
evident regarding lumbar spine x-rays that corroborate that there is no instability of the lumbar
spine, or significant scoliosis. Additionally, there is no discussion of a DEXA scan having been
performed to evaluate for osteopenia or osteoporosis. These are FDA exclusions for the requested
procedure. Therefore, the requested lumbar disc replacement inpatient surgery is not medically
necessary for the treatment of this patient.
| 1 |
The patient is a 68-year-old male who has requested reimbursement for DecisionDx-Melanoma testing. The patient has requested reimbursement for DecisionDx-Melanoma testing performed on 11/23/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of this patient.
|
Upheld
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Medical Necessity
|
Summary Reviewer
The patient is a 68-year-old male who has requested reimbursement for DecisionDx-Melanoma testing. The patient has requested reimbursement for DecisionDx-Melanoma testing performed on 11/23/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of this patient. The physician reviewer found that the use of gene expression profiling (GEP) testing according to specific melanoma stage (either before or after sentinel lymph node biopsy) requires rather prospective investigation in large, contemporary datasets of unselected patients. Prognostic 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. Commercially available GEPs, such as DecisionDx-Melanoma, are marketed as being able to classify cutaneous melanoma into separate categories based 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 clinicopathologic 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. 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 11/23/20 was not medically necessary for the evaluation of this patient.
| 1 |
A 36-year-old male enrollee has requested reimbursement for an implantable ambulatory event monitor provided on 12/28/17. The Health Insurer has denied this request indicating that the device at issue was considered investigational for evaluation of the enrollee, who reported palpitations. The physician reviewer found that the patient is a 36-year-old male with a history of hypertension and diabetes. He reported palpitations. Per the records, the patient underwent a 30-day external event monitor which revealed a symptomatic, but single episode, of atrial fibrillation lasting approximately 30 seconds. He was referred for implantable loop recorder to further assess atrial arrhythmic burden. The patient has requested reimbursement for an implantable ambulatory event monitor provided on 12/28/17. The Health Insurer has denied this request and reported that the device at issue was investigational for the evaluation of this patient. The patient has symptoms of palpitations and would be at
he had a significant burden atrial fibrillation associated with these episodes. He would
lifelong anticoagulation. He was first assessed appropriately with an external 30-day event monitor which revealed one episode of symptomatic, although short-lived, atrial fibrillation.
|
Upheld
|
Experimental
|
Summary Reviewer 1
A 36-year-old male enrollee has requested reimbursement for an implantable ambulatory event monitor provided on 12/28/17. The Health Insurer has denied this request indicating that the device at issue was considered investigational for evaluation of the enrollee, who reported palpitations. The physician reviewer found that the patient is a 36-year-old male with a history of hypertension and diabetes. He reported palpitations. Per the records, the patient underwent a 30-day external event monitor which revealed a symptomatic, but single episode, of atrial fibrillation lasting approximately 30 seconds. He was referred for implantable loop recorder to further assess atrial arrhythmic burden. The patient has requested reimbursement for an implantable ambulatory event monitor provided on 12/28/17. The Health Insurer has denied this request and reported that the device at issue was investigational for the evaluation of this patient. The patient has symptoms of palpitations and would be at higher risk for embolic stroke if he had a significant burden atrial fibrillation associated with these episodes. He would then likely require lifelong anticoagulation. He was first assessed appropriately with an external 30-day event monitor which revealed one episode of symptomatic, although short-lived, atrial fibrillation. A single 30-second episode of atrial fibrillation may not be a definite indication to commit this patient to lifelong anticoagulation, but more sustained or frequent episodes may be an indication for lifelong anticoagulation. In this setting, an implantable recording device is a reasonable next step to assess the full burden of atrial fibrillation prior to starting anticoagulation. Therefore, implantable ambulatory event monitor provided on 12/28/17 was likely to have been more effective than other methods of evaluating this patient. Based upon the information set forth above, the device 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 56-year-old male enrollee has requested reimbursement for service code 84999, OncotypeDX prostate cancer assay completed on 6/6/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees prostate cancer.
|
Overturned
|
Experimental
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Summary Reviewer 1
A 56-year-old male enrollee has requested reimbursement for service code 84999, OncotypeDX prostate cancer assay completed on 6/6/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees prostate cancer. The physician reviewer found that the medical evidence has not demonstrated the superior efficacy of the services at issue in this clinical setting. There are three major therapeutic approaches to the management of apparently localized prostate cancer. These include radical prostatectomy, radiation therapy, and surveillance with no specific treatment. Recommendations are made as to these options based on risk stratification, meaning an estimate of the risk for the future development of recurrence. The patients prostate cancer is evaluated with a combination of clinical features, prostate-specific antigen, and pathologic features. Thus, patients essentially can be placed into four categories: very low-risk, low-risk, intermediate risk, and high-risk. Based on the records, this patient would be placed in a very low-risk category for which active surveillance would be a good option. A further refinement of prognostication is the use of gene panels, such as OncotypeDX. This is a 17 gene panel that is capable of predicting recurrence of prostate cancer after treatment (Cheville, et al; Cullen, et al). However, this test has not been clinically validated (Moschini, et al). Moreover, it is particularly speculative as to whether it would be useful in this specific patient who was assessed with very low-risk disease. All told, service code 84999, OncotypeDX prostate cancer assay completed on 6/6/16 was not likely to have been more effective than the available treatment options 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 the evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 69-year-old female enrollee has requested reimbursement for lipoprotein (a) testing performed on 2/09/21. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
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Upheld
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Experimental
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Summary Reviewer 1
A 69-year-old female enrollee has requested reimbursement for lipoprotein (a) testing performed on 2/09/21. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. At issue is whether the services at issue were likely to have been more beneficial for evaluation of the enrolleeas condition than any available standard therapy. The physician reviewer found that there is a lack of accepted clinical studies demonstrating that strategies to correct the residual risk potentially identified by novel lipoprotein testing, such as the advanced lipoprotein analysis performed in this patientas case, will further reduce cardiac risk. It remains unclear from the current literature that such testing adds significant actionable information to what is already known from a fasting lipid panel, despite significant cost. There is insufficient evidence to support the use of advanced lipoprotein analysis in clinical practice, particularly in individuals at low risk such as the patient. In this case, the records document a recent coronary calcium score of zero. Therefore, lipoprotein (a) testing performed on 2/09/21 was not likely to have been more beneficial than other available methods of evaluating this patient.
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The patient is a 64-year-old male with a history of left hip and leg symptoms. The patient has
requested reimbursement for left lateral femoral nerve surgery performed on 11/15/18.
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is a 64-year-old male with a history of left hip and leg symptoms. The patient has
requested reimbursement for left lateral femoral nerve surgery performed on 11/15/18. The
physician reviewer found that California law defines an emergency medical condition as a
medical condition manifesting itself by acute symptoms of sufficient severity (including severe
pain) such that the absence of immediate medical attention could reasonably be expected to
result in any of the following: (1) Placing the patients health in serious jeopardy; (2) Serious
impairment to bodily functions; (3) Serious dysfunction of any bodily organ or part. Meralgia
paresthetica is a pain syndrome that results from compression or entrapment of the lateral
femoral cutaneous nerve. Patients can complain of pain and/or numbness in the region of the
lateral femoral cutaneous nerve. A number of treatment options are available, including
medications, injections, pulse radiofrequency neuromodulation, neurostimulation, neurolysis
and neurectomy. Surgery in the form of neurolysis or neurectomy is typically reserved for
patients who have failed non-surgical strategies. Based on the available literature and the
understanding of the pathology as an entrapment syndrome of a purely sensory nerve, it is
difficult to characterize meralgia paresthetica as a medical emergency. Based on the records, the
definition of emergency medical condition as a medical condition manifesting itself by acute
symptoms does not apply in this case. The patients symptoms were present for greater than six
years. This was not an acute problem. After careful evaluation of this case, a prudent layperson,
who possesses an average knowledge of health and medicine, would not reasonably expect the
absence of immediate medical attention to result in the following in this case: (i) placing the
health of the individual in serious jeopardy, (ii) serious impairment to bodily functions, or
(iii) serious dysfunction of any bodily organ or part. Therefore, left lateral femoral nerve surgery
performed on 11/15/18 was not emergent in nature.
| 1 |
A 64-year-old male enrollee has requested reimbursement for injection, immune globulin, Gammagard liquid, non-lyophilized, (e.g., liquid) 500 mg from 11/2/15 through 11/6/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees anti-GM1 polyneuropathy and Sjogrens syndrome.
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Overturned
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Experimental
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Summary Reviewer 2
A 64-year-old male enrollee has requested reimbursement for injection, immune globulin, Gammagard liquid, non-lyophilized, (e.g., liquid) 500 mg from 11/2/15 through 11/6/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees anti-GM1 polyneuropathy and Sjogrens syndrome. The physician reviewer found the current literature supports IVIG treatment in this clinical setting. As with most neuropathies, the cause of the neuropathy is thought to be autoimmune in nature. The use of IVIG is considered standard therapy in the treatment of neuropathies. Therefore, according to the current standard of care, the injection, immune globulin, (Gammagard liquid), non-lyophilized, (e.g., liquid), 500 mg from 11/2/15 through 11/6/15 was likely to be more effective than other therapies available for treatment of this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
The patient is a 58-year-old female under evaluation and treatment for GERD. The patient is considered to have both typical and atypical symptoms with only a partial response to proton pump inhibitor (PPI) therapy. Upper endoscopy showed no Barretts and a 1 cm hiatal hernia without esophagitis. Barium esophagram suggested normal peristalsis. The patient underwent a pH study of the esophagus which was positive for pathologic reflux with acidification of the esophagus 13% of the time. There was a poor correlation between acid reflux events and the timing of symptoms. The patient has requested authorization and coverage for the LINX procedure. The Health Insurer has denied this request indicating that the requested procedure is considered investigational.
This patient has a poor association between symptoms and episodes of pathologic reflux. In addition, the patient has atypical symptoms and only a partial response to PPI
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Upheld
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Experimental
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Summary Reviewer 3
The patient is a 58-year-old female under evaluation and treatment for GERD. The patient is considered to have both typical and atypical symptoms with only a partial response to proton pump inhibitor (PPI) therapy. Upper endoscopy showed no Barretts and a 1 cm hiatal hernia without esophagitis. Barium esophagram suggested normal peristalsis. The patient underwent a pH study of the esophagus which was positive for pathologic reflux with acidification of the esophagus 13% of the time. There was a poor correlation between acid reflux events and the timing of symptoms. The patient has requested authorization and coverage for the LINX procedure. The Health Insurer has denied this request indicating that the requested procedure is considered investigational. The U.S. Food Drug Administration (FDA) approved the LINX Reflux Management System for lower esophageal sphincter augmentation. Eligible patients for the procedure include those with inadequate symptom control with acid suppression therapy, including those patients with mild to moderate GERD and a hiatal hernia less than 3 cm. This patient has a poor association between symptoms and episodes of pathologic reflux. In addition, the patient has atypical symptoms and only a partial response to PPI therapy. These findings indicate that the patient will not experience improvement with a surgical approach to her reflux disease beyond what she has experienced with PPI therapy. For these reasons, the requested LINX procedure 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.
| 1 |
The patient is a 61-year-old female with a history of recurrent ovarian cancer diagnosed with multiple prior lines of therapy. Her tumor was submitted for molecular profiling with FoundationOne testing on 3/16/17. The patient has requested reimbursement for blood testing performed on 3/16/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational.
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Overturned
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Experimental
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Summary Reviewer 1
The patient is a 61-year-old female with a history of recurrent ovarian cancer diagnosed with multiple prior lines of therapy. Her tumor was submitted for molecular profiling with FoundationOne testing on 3/16/17. The patient has requested reimbursement for blood testing performed on 3/16/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational. Individualized molecular tumor profiling holds the promise of enabling personalized selection of molecularly targeted treatment based on the specific genotype identified. Several platforms are available, including the FoundationOne, Caris Target Now, and SNaPshot technology. The National Comprehensive Cancer Network (NCCN) guidelines recommend tumor molecular testing prior to initiation of therapy for recurrent or persistent ovarian cancer, if not previously done. Testing should include BRCA1 and BRCA2, homologous recombination pathway genes, and microsatellite instability (MSI) or DNA mismatch repair (MMR). Molecular profiling is now considered a standard of care in patients with recurrent or persistent ovarian cancer. Accordingly, the blood testing performed on 3/16/17 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.
| 1 |
A 55-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 9/02/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic.
In this patients case, her breast tissue was described as extremely dense.
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Overturned
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Experimental
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Summary Reviewer 2
A 55-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 9/02/16. 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 is a technique that was developed several years ago as a problem solving adjunct to routine mammography. Applying the same basic concept as computed tomography (CT) scanning, the logic is that by separating the various layers of breast tissue, one can better detect abnormalities. This has been shown to be most useful in the evaluation of dense breasts. In this patients case, her breast tissue was described as extremely dense. It is specifically those patients who have dense breasts that can benefit most from tomosynthesis. The ability to separate out the overlapping structures enables the possibility of demonstrating an otherwise occult tumor. In sum, digital breast tomosynthesis performed on 9/02/16 was likely to have been more effective than other modalities for evaluating this patient. 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 64-year-old female enrollee has requested reimbursement for genetic testing performed on
1/27/20. The Health Insurer has denied this request and reported that the services at issue were
investigational for the evaluation of the enrolleeas medical condition.
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Overturned
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Experimental
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Summary Reviewer 2
A 64-year-old female enrollee has requested reimbursement for genetic testing performed on
1/27/20. The Health Insurer has denied this request and reported that the services at issue were
investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that understanding the molecular drivers of cancer progression and metastases is an area of ongoing
and active research, predominantly driven by the goal of identifying specific genomic aberrations
that may ultimately result in individualized cancer treatment. In addition to likely providing
prognostic information, the value of next generation sequencing to predict candidates for specific
mutation-driven treatment holds promise. Patients with inflammatory and metastatic breast
cancers benefit from next-generation sequencing to identify markers that may indicate benefit from
targeted treatment or clinical trials. Therefore, genetic testing performed on 1/27/20 was likely to
have been more beneficial than other available standard therapy.
| 0 |
The parent of a 14-year-old female enrollee has requested reimbursement for scoliosis bracing provided on 1/10/18. The Health Insurer has denied this request indicating that the equipment at issue was not medically necessary for treatment of the enrollees scoliosis.
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Overturned
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Medical Necessity
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Summary Reviewer
The parent of a 14-year-old female enrollee has requested reimbursement for scoliosis bracing provided on 1/10/18. The Health Insurer has denied this request indicating that the equipment at issue was not medically necessary for treatment of the enrollees scoliosis. The physician reviewer found that the most common form of scoliosis, or spinal curvature, is idiopathic scoliosis, and it is further categorized by age grouping. Adolescent idiopathic scoliosis is generally discovered in children over ten years of age. By definition, the curvature must measure at least 10 degrees in one of the three directions. Mild curvature may go unnoticed, but significant curvature may be associated with respiratory difficulties, pain, and functional impairment. Bracing is considered to be the standard of care for idiopathic scoliosis in adolescents with immature skeleton and Cobb angle less than 40 degrees. This patient is within the range of therapy where bracing remains the treatment of choice, and is considered to be the standard of care. Therefore, scoliosis bracing provided on 1/10/18 was medically necessary for the treatment of this patient. Therefore, the equipment at issue was medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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A 60-year-old female enrollee has requested authorization and coverage for Taltz. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees psoriatic arthritis.
found that this patient failed therapy with Celebrex, methotrexate and Stelara, and she did not tolerate Enbrel and Humira. The records
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Upheld
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Medical Necessity
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Summary Reviewer
A 60-year-old female enrollee has requested authorization and coverage for Taltz. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees psoriatic arthritis. The physician reviewer found that this patient failed therapy with Celebrex, methotrexate and Stelara, and she did not tolerate Enbrel and Humira. The records do not document that she has tried and failed or has a contraindication the Health Insurers preferred therapy, Cosentyx (secukinumab). Per Patel and colleagues, based on available evidence, secukinumab offers an effective new addition to the psoriatic arthritis treatment repository. Mease and colleagues noted subcutaneous secukinumab provided sustained improvements in the signs and symptoms, quality of life and physical function of patients with active psoriatic arthritis with low rate of radiographic disease progression through three years. Taltz has not been demonstrated to be superior to Cosentyx in terms of efficacy or safety. Thus, Taltz is not medically necessary for the treatment of this patient. Therefore, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 28-year-old female enrollee has requested reimbursement for the Anser ADA testing performed on 12/1/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 3
A 28-year-old female enrollee has requested reimbursement for the Anser ADA testing performed on 12/1/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that the use of Anser ADA testing has not been clinically proven to improve patient clinical outcomes, and has not definitively demonstrated clinical utility. The effectiveness of Anser ADA compared with conventional courses of action remains unproven. Patients being treated with adalimumab may experience drug reactions or loss of response, but the appropriate method for determination of the cause for these is not clear. The published studies on the use of anti-adalimumab antibodies and serum levels are retrospective and/or observational in nature (Karmiris, et al; Imaeda, et al). The study by Karmiris and colleagues found no direct relationship between trough serum adalimumab concentration or anti-adalimumab antibody and short-term treatment efficacy. Prospective controlled trials providing evidence for the effectiveness of anti-adalimumab antibody testing and serum level testing as part of a clinical management strategy are lacking. In sum, there is a lack of medical literature supporting Anser ADA as likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
A 48-year-old female enrollee has requested reimbursement for electroretinography performed on 8/17/18. 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
that the medical records indicate that the patient has a history of diabetes and diabetic retinopathy.
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Upheld
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Experimental
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Summary Reviewer 2
A 48-year-old female enrollee has requested reimbursement for electroretinography performed on 8/17/18. 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 medical records indicate that the patient has a history of diabetes and diabetic retinopathy. The biggest ophthalmic risk from diabetes is diabetic retinopathy, which can also lead to diabetic macular edema. If not successfully treated, these conditions can lead to permanent loss of vision. Most ophthalmologists in the United States diagnose diabetic retinopathy and diabetic macular edema with a combination of physical examination of the retina through dilated pupils with indirect ophthalmoscopy and optical coherence tomography. Fundus photographs may be used to document the extent or severity of diabetic retinopathy for progression. Optical coherence tomography angiography and fluorescein angiography are used to document poor vascular perfusion or leakage in diabetic retinopathy/diabetic macular edema. Electroretinography uses a flash of light to generate an electromagnetic signal within the retina, which is then captured by an electrode on the surface of the eye. Jansson and colleagues noted photopic full-field electroretinography and spectral-domain optical coherence tomography derived retinal thickness parameters have limited clinical value in the staging of diabetic retinopathy. There is a lack of evidence indicating that electroretinography is a functionally useful tool in diagnosing diabetic retinopathy at this time. In sum, electroretinography performed on 8/17/18 was not likely to have been of greater benefit than other methods of evaluating this patient.
| 1 |
The patient is a 34-year-old female with a history of back pain. The patient has requested authorization and coverage for laminotomy (hemilaminectomy) L4-5. 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 patient has a documented herniation at L4-5, causing persisting mass effect upon the left L5 nerve root. This has been present for a year and is slightly improved on the recent MRI. She has failed conservative treatment and continues to be symptomatic at this time. The surgical level has been confirmed with epidural steroid injections. The provider has advised surgery with decompression of the nerve root.
The provider has requested laminotomy (hemilaminectomy) at L4-5 for decompression of the nerve root.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 34-year-old female with a history of back pain. The patient has requested authorization and coverage for laminotomy (hemilaminectomy) L4-5. 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 patient has a documented herniation at L4-5, causing persisting mass effect upon the left L5 nerve root. This has been present for a year and is slightly improved on the recent MRI. She has failed conservative treatment and continues to be symptomatic at this time. The surgical level has been confirmed with epidural steroid injections. The provider has advised surgery with decompression of the nerve root. A review of the literature indicates sufficient decompression of the nerve root canal is necessary when operating on patients with lumbar disc herniation with lumbar lateral recess stenosis. Microsurgical techniques and percutaneous techniques are common. Endoscopic techniques are also available. The provider has requested laminotomy (hemilaminectomy) at L4-5 for decompression of the nerve root. The request is supported by the medical literature. Therefore, the requested laminotomy (hemilaminectomy) L4-5 is medically necessary for the treatment of this patient.
| 1 |
A 62-year-old female enrollee has requested reimbursement for the breast tomosynthesis performed on 4/23/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees risk of breast cancer.
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Overturned
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Experimental
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Summary Reviewer 2
A 62-year-old female enrollee has requested reimbursement for the breast tomosynthesis performed on 4/23/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees risk of breast cancer. The physician reviewer found the breast tomosynthesis performed on 4/23/15 was likely to be more beneficial for evaluation of the patients medical condition than available standard modalities. There is support in the medical literature for the use of breast tomosynthesis compared to conventional mammogram due to improved cancer detection rate. According to 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. Based on the medical literature cited above, the use of breast tomosynthesis 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.
| 1 |
A 62-year-old male enrollee has requested reimbursement for homocysteine, Factor V Leiden and methylenetetrahydrofolate reductase (MTHFR) testing provided on 4/28/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees right lower extremity deep vein thrombosis (DVT).
In this case, the patient presented with spontaneous DVT of the right femoral and popliteal veins.
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Overturned
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Experimental
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Summary Reviewer 3
A 62-year-old male enrollee has requested reimbursement for homocysteine, Factor V Leiden and methylenetetrahydrofolate reductase (MTHFR) testing provided on 4/28/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees right lower extremity deep vein thrombosis (DVT). The physician reviewer found the homocysteine, Factor V Leiden and MTHFR testing provided on 4/28/16 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. There is sufficient support in the peer-reviewed literature for the testing at issue in this clinical setting. Patients with DVT have a high prevalence of inherited thrombophilic disorders and the testing at issue is recommended. In this case, the patient presented with spontaneous DVT of the right femoral and popliteal veins. In this clinical setting, 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 parent of a 16-year-old female enrollee has requested reimbursement for autonomic testing
performed on 8/19/20. The Health Insurer has denied this request and reported that the services
at issue were investigational for the evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 2
The parent of a 16-year-old female enrollee has requested reimbursement for autonomic testing
performed on 8/19/20. 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 medical evidence supports the services at issue in this clinical setting.
Prior to engaging in any course of treatment, it is imperative to have a working diagnosis. Despite being recognized as a very real clinical entity, the underlying etiology (or etiologies) of postural
orthostatic tachycardia syndrome (POTS) remain unclear, and there continues to be debates
about whether POTS is due to dysautonomia from peripheral nerve dysfunction versus central
nervous system dysfunction versus both. While salt tablets have been used empirically, there is
considerable room in the therapeutic armamentarium to consider clinical trials such as the
hyperpolarization-activated cyclic nucleotide-gated (HCN) channel blocker ivabradine. The first
step in the care of a patient with POTS-like symptoms is a thorough evaluation of the autonomic
nervous system, which was performed in this patients case. Therefore, autonomic testing
performed on 8/19/20 was likely to have been more beneficial than any available standard
therapy.
| 0 |
A 55-year-old male enrollee has requested authorization and coverage for the LINX lower esophageal sphincter augmentation device. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD).
et al). This patient has undergone much of this pre-operative assessment. The records provided for review demonstrate that this patient has GERD as based on pH recording, and that his response to maximized acid suppression
has been sub-optimal. The patient has no dysphagia, Barretts, large hiatal hernia,
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Overturned
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Experimental
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Summary Reviewer 2
A 55-year-old male enrollee has requested authorization and coverage for the LINX lower esophageal sphincter augmentation device. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD). The physician reviewer found that appropriate patient selection is crucial before anti-reflux procedures. In prelude to surgical intervention for GERD, currently upper endoscopy, barium esophagram, pH testing, and manometry are required for preoperative workup for antireflux surgery (Jobe, et al). This patient has undergone much of this pre-operative assessment. The records provided for review demonstrate that this patient has GERD as based on pH recording, and that his response to maximized acid suppression treatment has been sub-optimal. The patient has no dysphagia, Barretts, large hiatal hernia, or absolute surgical contraindications that disqualify him for LINX placement. It can be anticipated that the benefits of ant-reflux surgery with LINX implantation in this patients case will exceed available standard therapy. For these reasons, the requested LINX lower esophageal sphincter augmentation device 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 procedure is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 33-year-old male enrollee has requested reimbursement for Prometheus Anser ADA diagnostic testing performed on 5/19/14. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees Crohns disease. The physician reviewer found the patient was placed on Humira after the identification of a clinical and mucosal relapse while on Cimzia. In addition to 6-MP the patient was placed on an escalated dose of Humira. The patient began to show clinical improvement.
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Upheld
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Experimental
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Summary Reviewer 1
A 33-year-old male enrollee has requested reimbursement for Prometheus Anser ADA diagnostic testing performed on 5/19/14. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees Crohns disease. The physician reviewer found the patient was placed on Humira after the identification of a clinical and mucosal relapse while on Cimzia. In addition to 6-MP the patient was placed on an escalated dose of Humira. The patient began to show clinical improvement. There is a lack of controlled data concerning the testing for antibodies or adalimumab levels in this clinical scenario. There is a lack of established data indicating what drug level to target with adalimumab in the setting of an ileocolonic resection to prevent relapse. Given the lack of guidance in the peer-reviewed literature of when to test, how often to test, what to look for, and what to do with the results, the testing at issue was not likely to be more beneficial than other modalities. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 58-year-old male enrollee has requested reimbursement for the DecisionDx-Melanoma Gene Assay testing provided on 4/24/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees cutaneous melanoma.
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Overturned
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Experimental
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Summary Reviewer 2
A 58-year-old male enrollee has requested reimbursement for the DecisionDx-Melanoma Gene Assay testing provided on 4/24/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that the DecisionDx-Melanoma Assay tests the tissue genetics of the melanoma to help stratify whether a melanoma is high risk for metastasis. The DecisionDx-Melanoma Gene Assay has shown some accuracy in thin melanomas. The test is not considered routine standard of care and is not recommended by the National Comprehensive Cancer Network (NCCN) guidelines. However, when an SNLB is negative there is a no accounting for hematologic spread and the Class 2 results suggest there must be another type of spread other than lymphatic which is the only type of spread accounted for by the NCCN guidelines. In this case, the patient would benefit from close follow-up clinically with ultrasound and computed tomography (CT), since he is Class 2. Thus, the DecisionDx-Melanoma Gene Assay was likely to provide additional useful information in evaluating and treating this patient. All told, the DecisionDx-Melanoma Gene Assay testing provided on 4/24/17 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.
| 1 |
A 47-year-old female enrollee has requested reimbursement for the breast tomosynthesis performed on 4/24/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 3
A 47-year-old female enrollee has requested reimbursement for the breast tomosynthesis performed on 4/24/15. 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 that Tomosynthesis is a technique that was developed several years ago as a problem solving adjunct to routine mammography. Applying the same basic concept as computed tomography (CT) scanning, the logic is that by separating the various layers of breast tissue, one can better detect abnormalities. In this clinical setting, a breast tomosynthesis would be valuable in determining whether an area of asymmetry warrants a biopsy. However, the standard modalities would be more beneficial as the interpreting radiologist requested the old studies. There is always considerable variability in the appearance of breasts, and the most valuable tool is for the radiologist to compare the current study in question with old mammograms. In this case, the tomosynthesis provided 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.
| 1 |
An 18-year-old male enrollee has requested reimbursement for mental health partial hospitalization provided from 1/23/18 through 1/31/18 and 2/07/18 through 2/20/18 and intensive outpatient program services provided from 2/21/18 through 3/20/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions.
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Overturned
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Medical Necessity
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Summary Reviewer
An 18-year-old male enrollee has requested reimbursement for mental health partial hospitalization provided from 1/23/18 through 1/31/18 and 2/07/18 through 2/20/18 and intensive outpatient program services provided from 2/21/18 through 3/20/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found that in sum, intensive outpatient program services provided from 2/21/18 through 3/20/18 were medically necessary for the treatment of this patient. The submitted documentation fails to demonstrate the medical necessity of mental health partial hospitalization provided from 1/23/18 through 1/31/18 and 2/07/18 through 2/20/18.
| 0 |
The parent of a 15-year-old female enrollee has requested reimbursement for inpatient care from 4/13/17 through 4/19/17. 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 medical records indicate that this patient continued to exhibit the same acuity level of thoughts of self-harm and suicide that were the reason for her admission.
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Overturned
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Medical Necessity
|
Summary Reviewer
The parent of a 15-year-old female enrollee has requested reimbursement for inpatient care from 4/13/17 through 4/19/17. 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 supports the medical necessity of the services at issue. The medical records indicate that this patient continued to exhibit the same acuity level of thoughts of self-harm and suicide that were the reason for her admission. Transfer to residential treatment center level of care was not an option as the residential treatment center professionals felt she was still too acute and not ready for this transfer. Based on the records, continued treatment at the inpatient level of care was indicated. Her history shows that a premature discharge would result in a quick relapse and readmission. All told, inpatient care from 4/13/17 through 4/19/17 was medically necessary 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.
| 1 |
A 49-year-old female enrollee has requested reimbursement for laboratory services performed
at Diagnostic Solutions Laboratory on 3/29/22. The Health Insurer has denied this request and
reported that the services at issue were investigational for the evaluation of the enrollee.
reported diagnoses of irritable
bowel syndrome with constipation and noted that the patients predominant symptoms were
constipation and bloating. The records noted that gastrointestinal mapping revealed detectable
Clostridium difficile toxin and
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Upheld
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Experimental
|
Summary Reviewer 2
A 49-year-old female enrollee has requested reimbursement for laboratory services performed
at Diagnostic Solutions Laboratory on 3/29/22. The Health Insurer has denied this request and
reported that the services at issue were investigational for the evaluation of the enrollee. The
physician reviewer found that while there has been some investigation into the link between the
gut microbiome and gastrointestinal health and disease, there are no formal or scientifically
sound clinical trials evaluating microbiome testing and its utility in the workup and management
of irritable bowel syndrome. While Tap and colleagues note in an observational study that certain
microbiome profiles can help predict the severity of symptoms in irritable bowel syndrome, this
knowledge would not necessarily change the workup and management of the condition. In a
similar observation study, Zhu and colleagues found that patients with irritable bowel syndrome
had a significantly differential metabolite profile as compared to healthy controls, but again, such
information does not affect the manner in which irritable bowel syndrome would be tested for
or managed. There are no available studies for review that have investigated the general benefit
of comprehensive gastrointestinal mapping or its benefit over standard testing in the workup and management of irritable bowel syndrome. Notes dated 6/6/22 reported diagnoses of irritable
bowel syndrome with constipation and noted that the patients predominant symptoms were
constipation and bloating. The records noted that gastrointestinal mapping revealed detectable
Clostridium difficile toxin and elevated anti-Gliadin IgA levels. In this clinical setting, the positive
Clostridium difficile toxin that was identified in the gastrointestinal mapping could have been
identified through standard, widely available, focused stool testing. Further, the elevated anti-
Gliadin IgA could have been evaluated for with standard serum testing for celiac serologies.
Therefore, laboratory services performed at Diagnostic Solutions Laboratory on 3/29/22 were
not likely to have been more beneficial for evaluation of the patients condition than any available
standard therapy.
| 1 |
patient is a 52-year-old male who had a history of a stage IIB (T4N0) colon adenocarcinoma diagnosed in 2017. He was treated with adjuvant chemotherapy and was noted to have no mutations.
|
Overturned
|
Medical Necessity
|
Summary Reviewer
The patient is a 52-year-old male who had a history of a stage IIB (T4N0) colon adenocarcinoma diagnosed in 2017. He was treated with adjuvant chemotherapy and was noted to have no mutations. The physician reviewer found that as a standard of care, metastatic colon cancers should be tested for KRAS, NRAS, BRAF, HER2, and microsatellite instability (MSI) or mismatch repair (MMR) testing. Per the National Comprehensive Cancer Network guidelines, these can be done individually or as part of next-generation sequencing (NGS). NGS panels have the ability to pick up rare and actionable mutations and fusions. Universal genetic testing is recommended on all colon cancer tumors, and NGS allows for initial screening with MSI testing. NGS offers the advantage of identifying markers known to have targeted therapy as well as potential clinical trials. This patient has metastatic colon cancer that is recurrent. Although his initial tumor did not have any mutations, the panel has expanded since he was diagnosed, and recurrences can develop new mutations. The
medical evidence supports the services at issue in this clinical setting. Therefore, CPT codes 81202, 91275, 81292, 81298, 81301, 81311, 81321, 81404, 81406 XU x 2 and 81479 XU x 4 performed on 5/12/19 were medically necessary for the evaluation of this patient.
| 1 |
A 42-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis provided on 10/7/16. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees breast cancer examination.
In this case, the patient has breasts that have been described as heterogeneously dense.
|
Overturned
|
Experimental
|
Summary Reviewer 3
A 42-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis provided on 10/7/16. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees breast cancer examination. The physician reviewer found that the Tomosynthesis is a technique that was developed as a problem solving adjunct to routine mammography. In this case, the patient has breasts that have been described as heterogeneously dense. It is specifically those patients who have dense breasts that can benefit most from tomosynthesis. The ability to separate out the overlapping structures enables the possibility of demonstrating an otherwise occult tumor. In addition, there was identified a questionable mass, and tomosynthesis will often better localize, confirm, and characterize a mass. Accordingly, the digital breast tomosynthesis performed on 10/7/16 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.
| 1 |
A 47-year-old female enrollee has requested reimbursement for the breast tomosynthesis performed on 4/24/15. 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 1
A 47-year-old female enrollee has requested reimbursement for the breast tomosynthesis performed on 4/24/15. 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 that there is sufficient support in the peer-reviewed literature for the services at issue in this clinical setting. Skaane and colleagues performed a large prospective screening trial To assess cancer detection rates, false-positive rates before arbitration, positive predictive values for women recalled after arbitration, and the type of cancers detected with use of digital mammography alone and combined with tomosynthesis. The authors concluded that 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. Given the support in the medical literature, the use of breast tomosynthesis was likely to be more beneficial for evaluation of the patients breast exam than conventional mammogram is due to improved cancer detection rate. 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 |
The patient is a 66-year-old male who has a history of hyperlipidemia and moderate coronary
disease. The patient has requested authorization and coverage for Vascepa (icosapent ethyl
capsule 1 gm). The patients parent has requested authorization and coverage for Norditropin
(somatropin) 10 mg in 1.5 ml.
. This patient has
significant cardiovascular disease with documented coronary atherosclerosis. The
|
Overturned
|
Medical Necessity
|
Summary Reviewer
The patient is a 66-year-old male who has a history of hyperlipidemia and moderate coronary
disease. The patient has requested authorization and coverage for Vascepa (icosapent ethyl
capsule 1 gm). The patients parent has requested authorization and coverage for Norditropin
(somatropin) 10 mg in 1.5 ml. The physician reviewer found that in the REDUCE-IT trial, Vascepa
was shown to be superior to placebo in reducing triglycerides, cardiovascular events and
cardiovascular death among patients with high triglycerides and either known cardiovascular
disease or patients with diabetes plus significant cardiovascular risk factors. This patient has
significant cardiovascular disease with documented coronary atherosclerosis. The submitted
documentation included laboratory testing from 2003, 2007 and 2008. These records
documented elevated triglyceride levels. Vascepa is indicated for elevated triglycerides in
patients with cardiovascular disease or diabetics with cardiovascular risk factors. There is
sufficient support for the requested medication in this clinical setting. Therefore, Vascepa
(icosapent ethyl capsule 1 gm) is medically necessary for the treatment of this patient.
| 1 |
A 43-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 2/14/18. 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 3
A 43-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 2/14/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that Melanoma is a cancer that is curable in its earliest stages. Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76 to 1.0 mm. Metastases to regional lymph nodes may be amenable to excision, but this suggests a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha. The data on DecisionDx-Melanoma testing for melanoma 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 2/14/18 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
The patient is a 40-year-old transgender female who is seeking facial feminization surgery. Per the Health Insurer, the requested services are
|
Overturned
|
Medical Necessity
|
Summary Reviewer
The patient is a 40-year-old transgender female who is seeking facial feminization surgery. Per the Health Insurer, the requested services are not medically necessary for the treatment of the patientas medical condition. The physician reviewer found that the current medical evidence supports the requested services in this clinical setting. Facial feminization surgery is a common treatment for gender dysphoria. Ainsworth and Spiegel demonstrated that facial feminization surgery, like genital surgery, aimproved mental health-related quality of life.a The World Professional Association for Transgender Health (WPATH) Position Statement on Medical Necessity of Treatment states, aNon-genital surgical proceduresa notably facial feminization surgeryaare often of greater practical significance in the patientas daily life than reconstruction of the genitalsaThese reconstructive procedures are not optional in any meaningful sense, but are understood to be medically necessary for the treatment of the diagnosed condition.a Therefore, the requested facial feminization surgery is medically necessary for the treatment of this patient.
| 1 |
The parent of a one-year-old male enrollee has requested reimbursement for inpatient hospital level of care provided on 3/31/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees gastroesophageal reflux disease (GERD). The physician reviewer found the patient was a five-month-old ex-premature infant who was approximately 44 weeks post conceptual age at the time that he presented for apnea and cyanosis associated with vomiting for which he was treated with back blows by his mother. The apneic episode resolved by the time of presentation to the hospital and he appeared to be healthy when evaluated by the provider. He was admitted for observation and cardiopulmonary monitoring. He was diagnosed with an apparent life threatening event (ALTE) due to gastroesophageal reflux disease (GERD). Other than monitoring, he received a suppository to treat constipation. He had no further apnea or cyanosis in the hospital. He tolerated oral intake without emesis. He remained well appearing and had no signs of acute illness.
|
Upheld
|
Medical Necessity
|
Summary Reviewer
The parent of a one-year-old male enrollee has requested reimbursement for inpatient hospital level of care provided on 3/31/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees gastroesophageal reflux disease (GERD). The physician reviewer found the patient was a five-month-old ex-premature infant who was approximately 44 weeks post conceptual age at the time that he presented for apnea and cyanosis associated with vomiting for which he was treated with back blows by his mother. The apneic episode resolved by the time of presentation to the hospital and he appeared to be healthy when evaluated by the provider. He was admitted for observation and cardiopulmonary monitoring. He was diagnosed with an apparent life threatening event (ALTE) due to gastroesophageal reflux disease (GERD). Other than monitoring, he received a suppository to treat constipation. He had no further apnea or cyanosis in the hospital. He tolerated oral intake without emesis. He remained well appearing and had no signs of acute illness. The medical literature supports hospitalization for observation for cardiopulmonary monitoring for 23 hours after an ALTE in the majority of infants (Fu and Moon; McGovern and Smith). However, certain individuals can be discharged from the emergency department without hospitalization (Kahn and European Society for the Study and Prevention of Infant Death). Given that the patient was well-appearing at the time of presentation, had no further events during observation in the hospital, did not require specific interventions or extensive evaluation beyond observation, and was discharged home on the same day of admission, he met criteria for observation but not admission. Based upon the information provided and reviewed and the medical literature reviewed, the inpatient hospital level of care provided on 3/31/16 was not medically necessary for treatment of the patients medical condition. For the reasons provided, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 41-year-old male enrollee has requested authorization and coverage for a spine procedure. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition.
In this case, the patient has chronic low back pain that has not responded to at least six months of conservative care. The patient has had multiple treatments, including lumbar epidural steroid injections, medial branch blocks, aquatic therapy, massage therapy, home exercise program, stretching, cryotherapy, transforaminal epidural steroid injection, chiropractic manipulation and
|
Overturned
|
Experimental
|
Summary Reviewer 2
A 41-year-old male enrollee has requested authorization and coverage for a spine 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 evidence-based support for this procedure. In this case, the patient has chronic low back pain that has not responded to at least six months of conservative care. The patient has had multiple treatments, including lumbar epidural steroid injections, medial branch blocks, aquatic therapy, massage therapy, home exercise program, stretching, cryotherapy, transforaminal epidural steroid injection, chiropractic manipulation and medication management. There are also Type II Modic changes in the lumbar spine at the L3-4 and L4-5 levels. There is sufficient evidence-based support for the requested services. There has been sufficient, documented, detailed, comprehensive and reasonable treatment provided prior to this request. Therefore, the requested spine procedure is likely to be more beneficial for the treatment of the patientas medical condition than any available standard therapy.
| 1 |
A 27-year-old female enrollee has requested reimbursement for genetic testing including methylenetetrahydrofolate reductase (MTHFR) gene analysis, common variants, and factor V Leiden mutation testing provided on 7/1/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees risk for bleeding disorder.
|
Overturned
|
Experimental
|
Summary Reviewer 1
A 27-year-old female enrollee has requested reimbursement for genetic testing including methylenetetrahydrofolate reductase (MTHFR) gene analysis, common variants, and factor V Leiden mutation testing provided on 7/1/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees risk for bleeding disorder.
The physician reviewer found that there is a lack of large well defined studies that support the superiority of the services at issue when compared to the available standard options of evaluating this patient. A January 2011 guideline from the Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group recommends against routine testing for factor V Leiden and/or the prothrombin 20210 mutation in asymptomatic family members of patients with venous thromboembolism. In this patients case, the genetic testing would not have provided a greater value in the assessment of this patients condition over the standard options available. As such, genetic testing including MTHFR gene analysis, common variants, and factor V Leiden mutation testing provided on 7/1/17 was not likely to have been superior over any of the available standard methods of evaluating this patient.
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
| 1 |
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