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A 47-year-old female enrollee has requested reimbursement and prospective authorization and coverage for pertuzumab injections from 8/18/15 forward. The Health Insurer has denied this request indicating that the services at issue were and are considered investigational for treatment of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 3
A 47-year-old female enrollee has requested reimbursement and prospective authorization and coverage for pertuzumab injections from 8/18/15 forward. The Health Insurer has denied this request indicating that the services at issue were and are considered investigational for treatment of the enrollees medical condition. The physician reviewer found the records fail to demonstrate the superior efficacy of the services at issue. In this clinical setting, chemotherapy and one year of trastuzumab is the standard of care. Pertuzumab is a humanized monoclonal antibody that binds to the extracellular portion of the HER2 protein. The U.S. Food and Drug Administration (FDA) has approved its use in metastatic breast cancer and in neoadjuvant treatment of HER2-positive locally advanced, inflammatory, or early stage breast cancer. However, it is not part of regimens given postoperatively. Furthermore, the FDA approval was based on pathologic complete response rates and not on survival criteria. Per the current medical evidence, pertuzumab injections from 8/18/15 forward were not and are not likely to be of greater benefit than other alternatives. Based upon the information set forth above, the services at issue were not and are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 45-year-old male enrollee has requested reimbursement for air ambulance transport provided on 12/17/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition.
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Overturned
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Medical Necessity
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Summary Reviewer
A 45-year-old male enrollee has requested reimbursement for air ambulance transport provided on 12/17/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that it is in the best interest of patient safety to transfer to the nearest appropriate facility that has the ability to best care for the injury or illness. Transfers are inherently fraught with risk, and air transfers in particular carry their own set of additional complicating factors. The determination of what is the most appropriate facility can be very complex and involves many factors, only one of which is proximity to the sending facility. It is best left in the hands of the clinical team with hands on the patient at the time a facility is to be selected to determine what his or her needs are and, therefore, what the most appropriate facility is. This based on services, availability in the moment, proximity, reachability, family/social network, and many other factors that are only possible to determine in real time. In this patients case, ground transportation or commercial air travel were not appropriate options. The medical evidence supports the services at issue in this clinical setting. Therefore, air ambulance transport provided on 12/17/18 was medically necessary for the treatment of this patient.
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The patient is a 36-year-old female. The patient has requested authorization and coverage for
NuvaRing.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 36-year-old female. The patient has requested authorization and coverage for
NuvaRing. The physician reviewer found that at issue is whether NuvaRing is medically necessary
for the treatment of this patient. The submitted documentation supports the medical necessity
of the requested medication. The American College of Obstetricians and Gynecologists (ACOG)
states, All U.S. Food and Drug Administration (FDA) approved contraceptive methods should be
available to all insured women without cost sharing and without the need to fail certain
methods first. In the absence of contraindications, patient choice and efficacy should be the
principal factors in choosing one method of contraception over another." Different formulations
of hormonal birth control may be indicated for different patients due to their symptomology and
past medical history, and may be used for indications in addition to contraception. Generally, if
a patient who has been stable on a brand-name medication for a significant period of time
encounters side effects when switching to the generic formulation, continued maintenance on
the brand-name version of the medication is indicated. Therefore, NuvaRing is medically
necessary for the treatment of this patient.
| 1 |
A 61-year-old female enrollee has requested authorization and coverage for breath hydrogen/methane test (91065). The Health Insurer has denied this request and reported that the requested services are investigational for the evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 2
A 61-year-old female enrollee has requested authorization and coverage for breath hydrogen/methane test (91065). The Health Insurer has denied this request and reported that the requested services are investigational for the evaluation of the enrollees medical condition. The physician reviewer found that breath tests are based on the principle that metabolism of a test dose of carbohydrate substrate (e.g., lactulose) by the bacterial flora leads to the production of an analyte (hydrogen, methane), which is absorbed and ultimately excreted in the breath. Lactulose is a non-absorbable substance that is normally metabolized by gut bacteria in the colon with the production of hydrogen and/or methane. In theory, in individuals without small intestinal bacterial overgrowth, the administration of lactulose results in a single peak in breath hydrogen/methane within two to three hours due to the metabolism of lactulose by colonic flora. In patients with small intestinal bacterial overgrowth, administration of lactulose results in an early peak in breath hydrogen/methane levels due to metabolism by small bowel bacteria. In reality, this test is inaccurate. The main reason is that rapid transit of lactulose can occur. This will result in the presence of an early peak, misleading one to believe the patient has small intestinal bacterial overgrowth. A double peak is often not seen in cases of true small intestinal bacterial overgrowth. Therefore, there are many false positives and false negatives. In sum, a breath hydrogen/methane test (91065) is not likely to be of greater benefit than other methods of evaluating this patient.
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The parent of a 17-year-old male enrollee has requested reimbursement for residential treatment at Arivaca Boys Ranch from 5/26/16 through 2/13/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition.
On 5/26/16, the patient met the following criteria prior to admission to the residential treatment facility. The patients score for risk of harm was a 1,
low risk. Per the documentation, the patient had no history of suicide attempts. He did not have any suicidal ideation at the time of admission. He was screened at the RTC and was determined to be a no safety risk. The patients functional status was a 3, which is a moderate functional impairment due to a very conflictual relationship with his parents. The patient has been tardy to school and there were concerns that if his behavior continued, disciplinary actions would be taken by the school.
Additionally, the patient had a comorbidity related to his diagnoses of oppositional defiant disorder, attention deficit hyperactivity disorder, and marijuana abuse. The patients substance abuse was having a significant adverse effect on his functioning. However, the patient appeared to be medically stable and did not have any medical conditions that required 24 hour monitoring. With regard to his recovery environment, his score is a
his environmental support was a 2, because both parents were
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Upheld
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Medical Necessity
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Summary Reviewer
The parent of a 17-year-old male enrollee has requested reimbursement for residential treatment at Arivaca Boys Ranch from 5/26/16 through 2/13/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity for the services at issue in this clinical setting. Based on national guidelines, at the time of admission, the patient could have received services at a lower level of care. The Child and Adolescent Level of Care Utilization System (CALOCUS) is an accepted, national standard for determining the appropriate level of care for children and adolescents. On 5/26/16, the patient met the following criteria prior to admission to the residential treatment facility. The patients score for risk of harm was a 1, which translates to low risk. Per the documentation, the patient had no history of suicide attempts. He did not have any suicidal ideation at the time of admission. He was screened at the RTC and was determined to be a no safety risk. The patients functional status was a 3, which is a moderate functional impairment due to a very conflictual relationship with his parents. The patient has been tardy to school and there were concerns that if his behavior continued, disciplinary actions would be taken by the school. His comorbidity was also scored as a 3, which correlates to a significant comorbidity. Additionally, the patient had a comorbidity related to his diagnoses of oppositional defiant disorder, attention deficit hyperactivity disorder, and marijuana abuse. The patients substance abuse was having a significant adverse effect on his functioning. However, the patient appeared to be medically stable and did not have any medical conditions that required 24 hour monitoring. With regard to his recovery environment, his score is a 2, which relates to a mildly stressful environment. The patients parents were supportive. However, there was conflict in the home due to expectations from the parents and/or from the school. The conflict led to arguments and contributed to his oppositional behavior. The patients score with regard to his environmental support was a 2, because both parents were supportive. As for his score in the area of resiliency and treatment, the patient had limited ability to deal with stressors. He demonstrated a limited ability to follow through with recommendations from his prior outpatient therapist. As such, his score in the area of equivocal resiliency and response to treatment was a 3. He also scored a 3 in the area of acceptance and engagement at the time of admission. The patient did not want to be in care. However, it appears from the notes, the patient was able to develop positive relationships with the providers during his RTC stay. In sum, according to the CALOCUS scoring system, this patients composite score at the time of admission was 17. The patient required treatment for his marijuana abuse, ODD, and ADHD, but his treatment could have been performed at a less restrictive environment like in an intensive outpatient program. It is standard of care to treat the patient in the least restrictive environment possible. Moreover, it was noted that the patient reported to the RTC staff that he wished to be treated in a less restricted environment. Based on the CALOCUS system as well as peer reviewed medical literature, this patient could have been treated in a less restricted environment. Therefore, residential treatment at Arivaca Boys Ranch from 5/26/16 through 2/13/17 was not medically necessary for treatment of this patient.
Therefore, for the reasons stated above, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 48-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 12/12/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma.
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Upheld
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Experimental
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Summary Reviewer 1
A 48-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 12/12/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that the prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index may also add to these statistics. DecisionDx-Melanoma testing is a study of 31 genes in an individuals melanoma cells. It then classifies that particular melanoma based on the risk of metastasis over five years. Gerami reported on 217 cases, with good correlation between prognosis and DecisionDx-Melanoma classification, in patients undergoing sentinel node sampling. However, it is not clear how the five-year DecisionDx-Melanoma data compares to the ten-year Balch data. Most importantly, it is not clear that it can be used to make clinical decisions. Therefore, DecisionDx-Melanoma testing performed on 12/12/17 was not likely to have been more effective than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 57-year-old female enrollee has requested reimbursement for bilateral breast magnetic resonance imaging (MRI) performed on 7/21/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees medical condition.
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Upheld
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Medical Necessity
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Summary Reviewer
A 57-year-old female enrollee has requested reimbursement for bilateral breast magnetic resonance imaging (MRI) performed on 7/21/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees medical condition. The physician reviewer found there is a lack of support for the services at issue in this clinical setting. The literature does not recommend the use of breast MRI as a replacement for routine breast mammography and ultrasound. MRI studies of the breast are highly sensitive, but have a relatively low level of specificity. It is common for an MRI to suggest a significant lesion, at which point the patient is often subjected to ultimately unnecessary biopsies. The medical evidence supports routine physical examinations as well as routine screening mammography as the best means to detect recurrence. Moy and colleagues specifically addressed the issue of how to monitor patients with newly diagnosed stage 1 breast cancer. The authors noted women newly diagnosed with stage 1 breast cancer have an early-stage disease that can be effectively treated. Evidence provides little justification for performing imaging to exclude metastasis in asymptomatic women with stage 1 breast cancer. No differences have been found in survival or quality of life in women regardless of whether they underwent initial workup for metastatic disease. Moy and colleagues noted, American Society of Clinical Oncology and National Comprehensive Cancer Network guidelines state that annual mammography is the only imaging examination that should be performed to detect a localized breast recurrence in asymptomatic patients. Additional imaging may be needed if the patient has locoregional symptoms. In this patients case, there were apparently no clinical or imaging signs of recurrent tumor. Routine surveillance mammography and possibly breast tomosynthesis should be sufficient in this clinical setting. All told, bilateral breast MRI performed on 7/21/15 was not medically indicated for the evaluation of this patient. Therefore, the services at issue were not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
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A 33-year-old female enrollee has requested reimbursement for fecal lactoferrin testing performed on 12/06/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeAaas medical condition.
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Upheld
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Experimental
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Summary Reviewer 1
A 33-year-old female enrollee has requested reimbursement for fecal lactoferrin testing performed on 12/06/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeAaas medical condition. The physician reviewer found that in MosliAaas comparative meta-analysis of 19 studies, the diagnostic accuracy of C-reactive protein, fecal calprotectin, or stool lactoferrin was examined against endoscopy as a gold standard in
patients with symptoms/signs consistent with active inflammatory bowel disease. Fecal calprotectin was found to be more sensitive than C-reactive protein for this patientAaas indication. Similar results were reported by Menees and colleagues. In this meta-analysis which evaluated the performance of fecal calprotectin in distinguishing between inflammatory bowel disease and irritable bowel syndrome, patients with a fecal calprotectin level of less than 40 microg/g had a 1 percent chance or less of having inflammatory bowel disease. Fecal calprotectin has in recent years become increasingly attractive to some clinicians for assessment of inflammatory bowel disease activity in lieu of direct imaging of the gut.
Whereas conditions like irritable bowel syndrome and CrohnAaas disease could have been suspected as contributory to the patientAaas symptoms, no specific mention was made by the patientAaas provider that inflammatory bowel disease was under consideration. In this case, lactoferrin testing was not supported in the face of many other concomitantly-ordered inflammatory markers that proved negative, such as C-reactive protein, sedimentation rate, leukocyte count, or fecal calprotectin. With so many other negative inflammatory markers, the likelihood of a missed inflammatory bowel disease diagnosis was remote. Therefore, fecal lactoferrin testing performed on 12/06/19 was not likely to have been more beneficial than any available standard therapy.
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A 53-year-old female enrollee has requested authorization and coverage for autologous cultured chondrocytes implant knee. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.
this patient presents with a history of progressively worsening bilateral knee pain.
in activities of daily living and recreational pursuits. She is status post bilateral knee arthroscopy, chondroplasty, synovectomy, and plica resection, and chondral biopsy on the right knee on 7/18/18. The surgeon reports left knee operative findings included a grade IV chondral defect in the lateral facet of the patella measuring 2 x 2 cm, and a grade III defect on the anterolateral trochlea measuring 5 x 5 mm. All defects had been debrided back to stable margins with Outerbridge grade I/II at the lesion borders. She subsequently underwent right knee surgery, including the matrix-induced autologous cho
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Overturned
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Experimental
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Summary Reviewer 2
A 53-year-old female enrollee has requested authorization and coverage for autologous cultured chondrocytes implant knee. 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 a history of progressively worsening bilateral knee pain. Functional difficulty is reported in activities of daily living and recreational pursuits. She is status post bilateral knee arthroscopy, chondroplasty, synovectomy, and plica resection, and chondral biopsy on the right knee on 7/18/18. The surgeon reports left knee operative findings included a grade IV chondral defect in the lateral facet of the patella measuring 2 x 2 cm, and a grade III defect on the anterolateral trochlea measuring 5 x 5 mm. All defects had been debrided back to stable margins with Outerbridge grade I/II at the lesion borders. She subsequently underwent right knee surgery, including the matrix-induced autologous chondrocyte implantation procedure. Evidence of a recent, reasonable and/or comprehensive nonoperative treatment protocol trial and failure has been submitted. Under consideration is a request for left knee matrix-induced autologous chondrocyte implantation. There is U.S. Food and Drug Administration (FDA) approval for the use of matrix-induced autologous chondrocyte implantation in this clinical setting. There is current peer-reviewed evidence indicating that matrix associated chondrocyte implantation is safe and effective for the treatment of full thickness cartilage defects in the knee, with no effect of the location of the defects or number of defects on study outcomes. In sum, autologous cultured chondrocyte implantation in the knee is likely to be more beneficial than other treatment options.
| 1 |
A 39-year-old male enrollee has requested reimbursement for the Factor V Leiden genetic testing and homocysteine testing provided on 3/23/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees superficial vein thrombophlebitis.
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Overturned
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Experimental
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Summary Reviewer 3
A 39-year-old male enrollee has requested reimbursement for the Factor V Leiden genetic testing and homocysteine testing provided on 3/23/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees superficial vein thrombophlebitis. The physician reviewer found that patients who have had a deep venous thrombosis have a high prevalence of inherited thrombophilic disorders (Merriman and Greaves). However, the current medical literature does not support routine Factor V Leiden genetic testing and homocysteine testing for patients based on the presence of superficial venous thrombosis (Nakashima and Rogers). All told, the Factor V Leiden genetic testing and homocysteine testing provided on 3/23/16 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 62-year-old female enrollee has requested reimbursement for Guardant360 testing performed on 7/25/20. The Health Insurer indicates that the services at issue were investigational for the evaluation of the enrollees medical condition. Therefore, the Health Insurer has denied reimbursement for the services at issue.
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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 Guardant360 testing performed on 7/25/20. The Health Insurer indicates that the services at issue were investigational for the evaluation of the enrollees medical condition. Therefore, the Health Insurer has denied reimbursement for the services at issue. The physician reviewer found that adenocarcinoma of the lung should be evaluated for specific molecular and mutational targets, such as EGFR. ALK, ROS-1, and PDL-1 positivity. Each of these has a therapeutic implication. Usually, these are analyzed from the tissue biopsy specimen, although plasma assay does appear to be a reasonable substitute when tissue biopsy is not possible or safe. Even beyond that issue, in lung cancer, there is some data to indicate that plasma assay may actually be superior to tissue. Agarwal studied this issue in 323 patients, many of whom had both types of assays, but many only had the serum assay. It was noted that 33% of those who had only the serum assay had a targetable mutation, and 86% of these experienced a clinical response to treatment. Only 21% of those who had tissue assay alone had such a targetable situation. There is sufficient support for the services at issue in this clinical setting. Therefore, Guardant360 testing performed on 7/25/20 was likely to have been more beneficial than any available standard therapy.
| 0 |
The patient is a 53-year-old male with a history of clinically localized favorable intermediate risk adenocarcinoma of his prostate gland. The patient has requested reimbursement for 17 fraction treatments of IMRT provided from 3/05/21 through 3/29/21. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 53-year-old male with a history of clinically localized favorable intermediate risk adenocarcinoma of his prostate gland. The patient has requested reimbursement for 17 fraction treatments of IMRT provided from 3/05/21 through 3/29/21. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The physician reviewer found that the submitted documentation supports the medical necessity of the services at issue. The 17 additional fractions of IMRT were standard of care and medically necessary in this clinical setting. While hypofractionation is proven equivalent in terms of safety/efficacy for treatment of prostate cancer, conventional fractionation (45 fractions as requested) is standard of care and continues to be widely utilized throughout the radiation oncology community. National Comprehensive Cancer Network guidelines support the use of 45 fractions of IMRT in this setting, as do numerous high-quality prospective clinical outcomes published in the peer-reviewed medical literature. Therefore, 17 fraction treatments of IMRT provided from 3/05/21 through 3/29/21 were medically necessary for the treatment of this patient.
| 1 |
A 41-year-old male has requested authorization and coverage for the LINX procedure. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 3
A 41-year-old male has requested authorization and coverage for the LINX procedure. 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 there is a lack of randomized controlled trials comparing LINX with Nissen fundoplication or other surgical anti-reflux procedures. At this time, additional studies are needed to determine the long-term safety and efficacy as compared to other treatment modalities. Adverse events, such as erosion through the esophagus, have been reported in the period after U.S. Food and Drug Administration (FDA) approval. Additionally, LINX (more than surgical fundoplication) is associated with severe dysphagia requiring endoscopic intervention, which is a concern in this patients case. 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, the requested LINX procedure is not likely to be more effective 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.
| 0 |
The patient is a three-year-old male. An assessment dated 3/2/22 reported that the patient did not
have a history of seizures. The patients parent has requested reimbursement and prospective
authorization and coverage for private duty nursing, 12-hour days, seven days per week, from
3/1/22 to 12/31/22. The Health Insurer has denied this request and reported that the services at
issue were not and are not medically necessary for the treatment of this patient.
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is a three-year-old male. An assessment dated 3/2/22 reported that the patient did not
have a history of seizures. The patients parent has requested reimbursement and prospective
authorization and coverage for private duty nursing, 12-hour days, seven days per week, from
3/1/22 to 12/31/22. The Health Insurer has denied this request and reported that the services at
issue were not and 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 submitted
documentation does not support the medical necessity of the services at issue. Home based nursing
services are essential for parents of children with life-limiting diseases with basic healthcare needs
including personal hygiene and feeding, the administration of drugs and management of
symptoms, and pain and sleep related problems during the night. Lazzarin and colleagues report
that parents providing palliative care for children with life-limiting diseases spent an average of
nine hours a day caring for them each day and had to maintain an average of five medical
appliances. It is important for these families to receive appropriate support with daily care through
an evaluation of the childs individual needs. Current medical literature shows that the number of
medical appliances and the status of single caregivers correlate proportionally with a greater
amount of time needed for a childs care. The data suggests that it is not so much the childs disease
that determines the daily burden of care for the parents, but the number of different procedures
that must be expertly managed. In this case, the patient is not dependent on a ventilator, is not
using a feeding pump or indwelling catheters, and does not have life threatening seizures. Unlike
children with incurable conditions who are cared for at home and need highly complex medical
care, this childs quality-of-life may be adequately maintained without 12 hours/day in home
nursing service. Given that this patient does not have multiple chronic conditions or life-limiting
diseases that make him dependent on caregivers and the use of complex medical appliances or of
life sustaining medical devices, the services at issue were not and are not medically indicated.
Therefore, private duty nursing, 12-hour days, seven days per week, from 3/1/22 to 12/31/22, was
not and is not medically necessary for the treatment of this patient.
| 1 |
A 64-year-old female enrollee has requested reimbursement for Botox injections received on 10/9/14 and 10/29/15. The Health Insurer has denied this request indicating that the services at issue were investigational for treatment of the enrollees medical condition.
The patient presents with a history of bilateral breast cancer (at different times) and immediate breast reconstruction at two different time periods. Due to elevation of the pectoralis muscle, she underwent Botox administration for chemodenervation
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Upheld
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Experimental
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Summary Reviewer 1
A 64-year-old female enrollee has requested reimbursement for Botox injections received on 10/9/14 and 10/29/15. The Health Insurer has denied this request indicating that the services at issue were investigational for treatment of the enrollees medical condition. The physician reviewer found the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The patient presents with a history of bilateral breast cancer (at different times) and immediate breast reconstruction at two different time periods. Due to elevation of the pectoralis muscle, she underwent Botox administration for chemodenervation as a way to decrease muscle spasm and decrease postoperative pain. Although there may be some anecdotal evidence for the use of Botox when elevating the pectoralis muscle in breast reconstruction and augmentation mammoplasty to decrease muscle spasm and postoperative pain, there is insufficient evidence that Botox would be likely more beneficial than standard treatment in breast reconstruction. Therefore, without greater study with respect to Botox use in standard breast reconstruction, its use in this clinical setting was not likely to be more beneficial for treatment of the patients medical condition than other modalities. 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 |
The patient is a 62-year-old female with a history of mild bilateral carotid artery atherosclerosis, hyperlipidemia and hypertension.The patient has requested authorization and coverage for Repatha. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient.
the patient has prior evidence of established atherosclerotic vascular disease of the carotid arteries. She has hypertension and hyperlipidemia with a baseline LDL of 166. She is at risk for progression of her peripheral vascular disease and also development of coronary artery disease based on her age and risk factors. She was intolerant of four different statin medications and ezetimibe, which all had to be discontinued. She has had an excellent response to PCSK-9 therapy with Repatha, which has decreased her LDL to her goal without further side effects.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 62-year-old female with a history of mild bilateral carotid artery atherosclerosis, hyperlipidemia and hypertension.The patient has requested authorization and coverage for Repatha. 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 patient has prior evidence of established atherosclerotic vascular disease of the carotid arteries. She has hypertension and hyperlipidemia with a baseline LDL of 166. She is at risk for progression of her peripheral vascular disease and also development of coronary artery disease based on her age and risk factors. She was intolerant of four different statin medications and ezetimibe, which all had to be discontinued. She has had an excellent response to PCSK-9 therapy with Repatha, which has decreased her LDL to her goal without further side effects. Based on her known carotid artery disease, additional risk factors for coronary artery disease and intolerance of multiple statin therapies, PCSK-9 inhibitor therapy with Repatha is medically indicated. Therefore, Repatha is medically necessary for the treatment of this patient.
| 1 |
A 47-year-old male enrollee has requested authorization and coverage for hypoglossal nerve stimulation or Inspire upper airway stimulation system. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.
records noted intolerance to the use of continuous positive airway pressure therapy. A sleep study documented symptoms of obstructive sleep apnea with an apnea-hypopnea
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Overturned
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Experimental
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Summary Reviewer 3
A 47-year-old male enrollee has requested authorization and coverage for hypoglossal nerve stimulation or Inspire upper airway stimulation system. 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 sufficient support for the requested services in this clinical setting. The records noted intolerance to the use of continuous positive airway pressure therapy. A sleep study documented symptoms of obstructive sleep apnea with an apnea-hypopnea index at the moderate to severe level of obstructive sleep apnea syndrome, with oxygen desaturation to 82%. Hypoglossal nerve stimulation therapy has been demonstrated to be an effective modality for the treatment of obstructive sleep apnea in patients with tongue-based obstruction. The medical evidence supports the requested services for the treatment of this patient. Thus, the requested hypoglossal nerve stimulation or Inspire upper airway stimulation system is likely to be of greater benefit than other treatment options.
| 1 |
The parent of a five-year-old male enrollee has requested reimbursement for gene testing performed on 11/20/15. The Health Plan has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees generalized epilepsy of unknown etiology.
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Overturned
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Experimental
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Summary Reviewer 2
The parent of a five-year-old male enrollee has requested reimbursement for gene testing performed on 11/20/15. The Health Plan has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees generalized epilepsy of unknown etiology. The physician reviewer found the gene testing performed on 11/20/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. CMA has become standard of care to evaluate children with developmental delay, intellectual disability, autism spectrum disorders or congenital anomalies. Seven percent of microarray results impact clinical management, a rate which is similar to other genetic tests (Riggs, et al). Olson and colleagues found that at least 5% of individuals with epilepsy had pathogenic copy number variants. In sum, data have emerged showing that actionable findings from chromosomal microarray justify its use. All told, 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 |
A 59-year-old female enrollee has requested authorization and coverage for lumbar spine decompression and fusion. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition.
this patient presents with worsening low back pain radiating down the right lower extremity in an L4 distribution with associated numbness and tingling. Significant functional limitations are noted in activities of daily living and mobility. Her signs and symptoms are reported as positional and consistent with neurogenic claudication. She has failed to achieve adequate relief with long-term conservative treatment. Clinical examination findings have evidenced reflex changes consistent with imaging evidence of nerve root compromise and prominent facet degenerative change with facet cysts at the L4-5 and L5-S1 levels. There is reported radiographic evidence of spondylolisthesis at L4-5 and L5-S1 with spinal instability reported of 6-10 mm.
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Overturned
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Medical Necessity
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Summary Reviewer
A 59-year-old female enrollee has requested authorization and coverage for lumbar spine decompression and fusion. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that this patient presents with worsening low back pain radiating down the right lower extremity in an L4 distribution with associated numbness and tingling. Significant functional limitations are noted in activities of daily living and mobility. Her signs and symptoms are reported as positional and consistent with neurogenic claudication. She has failed to achieve adequate relief with long-term conservative treatment. Clinical examination findings have evidenced reflex changes consistent with imaging evidence of nerve root compromise and prominent facet degenerative change with facet cysts at the L4-5 and L5-S1 levels. There is reported radiographic evidence of spondylolisthesis at L4-5 and L5-S1 with spinal instability reported of 6-10 mm. Additionally, there is plausible need for wide decompression that would result in temporary intraoperative instability and necessitate fusion. The medical literature supports lumbar decompression and fusion in this clinical setting. Therefore, the requested lumbar spine decompression and fusion is medically necessary for the treatment of this patient.
| 1 |
A 23-year-old male enrollee has requested reimbursement for mental health residential treatment provided from 5/10/15 through 8/05/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions.
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Upheld
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Medical Necessity
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Summary Reviewer
A 23-year-old male enrollee has requested reimbursement for mental health residential treatment provided from 5/10/15 through 8/05/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the services at issue. This patient was not a danger to himself or others. The records do not document that he was aggressive, agitated, hostile, manic, or psychotic. There was no physician evaluation on admission, psychiatric or otherwise. There were no skilled nursing services provided. Groups were on a weekly, not daily, basis, and records do not show that therapeutic services were provided on a multiple-hours per day basis. The current medical evidence does not support the services at issue in this patients case, as there is no record of his behavior being hostile, aggressive, risky, dangerous to himself or others, or out of control prior to admission. The patient could have been treated on an outpatient basis, which would have been seen as the standard of practice in the community. All told, mental health residential treatment provided from 5/10/15 through 8/05/15 were not medically indicated for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 0 |
A 26-year-old female enrollee has requested reimbursement for DecisionDx testing performed on 4/28/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees cutaneous melanoma.
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Upheld
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Experimental
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Summary Reviewer 3
A 26-year-old female enrollee has requested reimbursement for DecisionDx testing performed on 4/28/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that the DecisionDx-Melanoma test is an attempt to determine risk of recurrence for early stage melanoma. However, the treatment protocol for follow up of melanoma patients is summarized in the National Comprehensive Cancer Network (NCCN) guidelines. These guidelines note there is a lack of data to support using adjuvant therapy based on DecisionDx testing results. The follow up of melanoma patients is not tailored to each patient risk of recurrence, but rather is global to all patients with melanoma. Given these findings, the DecisionDx testing performed on 4/28/17 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
The patient is a 55-year-old female with rheumatoid arthritis who has failed multiple therapies. These therapies have included Actemra, Simponi, Orencia, Humira and recently Xeljanz. The patient did not tolerate Arava. On 8/18/16, the records noted that the patient had been on Remicade in the past, and this medication was both tolerated and effective. The provider ordered Prometheus Anser IFX testing to determine if antibodies had been formed against infliximab (Remicade) due to prior therapy with Remicade and to determine if this would
. The Health Insurer has denied reimbursement for Prometheus Anser IFX testing performed on 8/19/16. Per the Health Insurer, the services at issue were investigational for the evaluation of this patient.
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Upheld
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Experimental
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Summary Reviewer 3
The patient is a 55-year-old female with rheumatoid arthritis who has failed multiple therapies. These therapies have included Actemra, Simponi, Orencia, Humira and recently Xeljanz. The patient did not tolerate Arava. On 8/18/16, the records noted that the patient had been on Remicade in the past, and this medication was both tolerated and effective. The provider ordered Prometheus Anser IFX testing to determine if antibodies had been formed against infliximab (Remicade) due to prior therapy with Remicade and to determine if this would be a suitable next therapy. The Health Insurer has denied reimbursement for Prometheus Anser IFX testing performed on 8/19/16. Per the Health Insurer, the services at issue were investigational for the evaluation of this patient. There is a lack of support for Prometheus Anser IFX testing in this patients case. The services at issue are not standard of care prior to starting patients on Remicade, even if they have been on it before. There is a lack of literature to support that testing of these antibodies changes the overall outcome or prognosis. Additionally, antibodies to anti-tumor necrosis factor agents can occur any time during therapy, but most often occur at the beginning of therapy and may be transient. Patients with anti-tumor necrosis factor antibodies do not necessarily always demonstrate a lack of response to therapy. Therefore, there is no one-to-one correlation between antibody formation and presence and failure to respond to Remicade. Thus, Prometheus Anser IFX testing performed on 8/19/16 was not likely to be more effective than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
The patient is a 52-year-old female. The patient has requested reimbursement for anesthesia
provided on 8/30/21.
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is a 52-year-old female. The patient has requested reimbursement for anesthesia
provided on 8/30/21. 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 prolonged or painful procedures such as complex polyp
resections, endoscopic retrograde cholangiopancreatography or other biliary procedures,
endoscopic dilation, or endoscopic resection. Additionally, the guidelines state that monitored
anesthesia care is more likely necessary in patients with a failed history of moderate sedation
for the procedure or psychological impediments to cooperation. The provided records do not
support any of these criteria, or other criteria in the literature, such as difficult intubation,
airway obstruction, allergies to sedation medications, chronic alcohol or illicit drug use resulting
in increased tolerance to sedation medications, age greater than 70, pregnancy, increased
aspiration risk, ASA class III or higher, or morbid obesity. According to the most recent
guidelines from the American Society for Gastrointestinal Endoscopy, during endoscopic
procedures (unlike surgery) consciousness during the procedure is acceptable and is the goal
during most procedures (which are performed with moderate sedation), and monitored
anesthesia care is recommended for prolonged procedures requiring deep sedation, previously
anticipated intolerance to standard sedatives, ASA class IV or V, or risk for airway obstruction
due to anatomic variant. For these reasons, the provided patient records do not support the
medical necessity of monitored anesthesia care over conscious sedation in this case. Therefore,
anesthesia provided on 8/30/21 was not medically necessary for the treatment of this patient.
| 1 |
The patient is a 47-year-old male with a history of chronic low back pain with lumbar
radiculopathy, lumbar disc herniation with radiculopathy, and lumbar spondylosis. The provider
has recommended treatment with lumbar spine surgery, open SI joint fusion, and one associated
inpatient bed day. The Health Insurer has denied the requested services as not medically
necessary for treatment of the patients medical condition.
. This patient is
being treated for chronic low back pain with lumbar radiculopathy, lumbar disc herniation with
radiculopathy, and lumbar spondylosis. The provider reported that the patient experiences
minimal pain with lumbar forward flexion, with apprehension. The patients flexion motion is
essentially full, but his extension is limited and causes lower back pain.
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Upheld
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Medical Necessity
|
Summary Reviewer
The patient is a 47-year-old male with a history of chronic low back pain with lumbar
radiculopathy, lumbar disc herniation with radiculopathy, and lumbar spondylosis. The provider
has recommended treatment with lumbar spine surgery, open SI joint fusion, and one associated
inpatient bed day. The Health Insurer has denied the requested services as not medically
necessary for treatment of the patients medical condition. The physician reviewer found that
there are limited large-scale, long-term references showing the safety and efficacy of the
requested lumbar spine surgery and open SI joint fusion in this clinical setting. This patient is
being treated for chronic low back pain with lumbar radiculopathy, lumbar disc herniation with
radiculopathy, and lumbar spondylosis. The provider reported that the patient experiences
minimal pain with lumbar forward flexion, with apprehension. The patients flexion motion is
essentially full, but his extension is limited and causes lower back pain. However, dynamic flexion-
extension films are not documented in order to assess the amount of movement or instability at
the requested surgical level. There is also a lack of documentation regarding potential temporary
intraoperative instability. According to Resnick and colleagues, As a result of the decompression,
the inherent instability associated with the spondylolisthesis may progress and lead to further
misalignment that results in pain or recurrence of neurological complaints. In another study,
Eismont and colleagues reported that, Although much has been published in the past two
decades on the surgical management of degenerative spondylolisthesis, the optimal method
remains controversial. Interbody fusion may improve arthrodesis rates and can be performed via
numerous surgical approaches. Minimally invasive techniques continue to be developed.
Furthermore, there is a lack of imaging or radiographic evidence supporting a sacroiliitis
pathology for this patient. Criteria supporting a sacroiliitis pathology include significant SI joint
pain and a lack of alternative diagnoses that could be responsible for the patients pain (Lorio
and Rashbaum). In this case, the records indicated SI joint testing showed minimal pain, and
multiple other plausible pain generators including at the lumbosacral spine are evident. Finally,
medical literature does support the use of open SI joint fusion as safe and effective for patients
with degenerative sacroiliitis refractory to nonoperative management (Smith, et al.; Ledonio, et
al.). Overall, there is a lack of diagnostic imaging studies corroborating degenerative sacroiliitis
for this patient. For these reasons, the requested lumbar spine surgery, open SI joint fusion, and
one associated inpatient bed day are not medically necessary for treatment of this patient.
| 1 |
A 53-year-old female enrollee has requested reimbursement for the bilateral three dimensional digital breast tomosynthesis provided on 10/16/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees risk for breast cancer.
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Overturned
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Experimental
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Summary Reviewer 2
A 53-year-old female enrollee has requested reimbursement for the bilateral three dimensional digital breast tomosynthesis provided on 10/16/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees risk for breast cancer. 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, by separating the various layers of breast tissue, one can better detect abnormalities. This patients breasts were described as heterogeneously dense. Thus, in this clinical setting, the use of the digital breast tomosynthesis performed on 10/16/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 41-year-old male enrollee has requested authorization and coverage for sacroiliac joint fusion. 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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Overturned
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Experimental
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Summary Reviewer 3
A 41-year-old male enrollee has requested authorization and coverage for sacroiliac joint fusion. 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 Sacroiliac joint degeneration is a common cause of chronic low back pain which is underdiagnosed. Minimally invasive fusion procedures have demonstrated successful pain relief for these individuals. Recent medical literature has documented two-year follow-up of these procedures demonstrating meaningful clinical improvement and maintained pain relief as well as evidence of a solid fusion on imaging studies. The article by Duhon and colleagues discussed long-term results from a prospective multicenter clinical trial. The authors noted minimally invasive sacroiliac joint fusion using triangular titanium implants showed marked improvements in pain, disability and quality of life at two years. Imaging showed that bone apposition to implants was common, but radiographic evidence of intra-articular fusion within the joint may take more than one year in many patients. This case illustrates the difficulty encountered in making an accurate diagnosis of chronic low back pain that does not respond to the usual conservative measures. In the absence of evidence of neural compression on the magnetic resonance imaging scan and in the presence of clinical findings of sacroiliac pain which is relieved by injecting the sacroiliac joint, the requested procedure of sacroiliac fusion using the minimally invasive technique is likely to be beneficial for this patient. Thus, the requested sacroiliac joint fusion is likely to be more effective than other treatment options.
| 0 |
The patient is an 18-year-old male with a longstanding history of abdominal pain and diarrhea
with night waking and slow weight gain. The patients parent has requested authorization and
coverage for treatment with Sucraid 8500 mL solution. The Health Insurer has denied the
requested medication as not medically necessary since the patients records do not support a
diagnosis of sucrase isomaltase deficiency.
mentel). The patient reportedly underwent C13 breath testing, which reflected low
sucrase-isomaltase activity.
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Upheld
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Medical Necessity
|
Summary Reviewer
The patient is an 18-year-old male with a longstanding history of abdominal pain and diarrhea
with night waking and slow weight gain. The patients parent has requested authorization and
coverage for treatment with Sucraid 8500 mL solution. The Health Insurer has denied the
requested medication as not medically necessary since the patients records do not support a
diagnosis of sucrase isomaltase deficiency. The physician reviewer found that the U.S. Food and
Drug Administration (FDA) has approved Sucraid for the treatment of patients with congenital
sucrase-isomaltase deficiency (CSID). Although dietary management of CSID is possible, it is
highly restrictive and would not be recommended for this adolescent patient with a history of
poor weight gain. However, this patients records do not support a diagnosis of CSID to support
an indication for treatment with Sucraid. The patients symptoms may also be consistent with IBS
(Shah and Pimentel). The patient reportedly underwent C13 breath testing, which reflected low
sucrase-isomaltase activity. This coupled with the providers report of the patients symptomatic
improvement with use of Sucraid is suggestive of CSID but is insufficient to support this diagnosis
without genetic testing. C13 breath testing is unable to distinguish between low sucrase activity
due to primary enzyme deficiency versus low activity due to mucosal damage. The European
Society for Pediatric Gastroenterology, Hepatology, and Nutrition recommends using genetic
testing for to confirm a diagnosis of CSID (Broekaert, et al.). In the absence of testing reporting a
diagnosis of CSID, this patient does not meet the requirements for treatment with Sucraid.
Therefore, the requested Sucraid 8500 mL solution is not medically necessary for treatment of
this patient.
| 1 |
A 68-year-old female enrollee has requested authorization and coverage for iStent placement (times two). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.
This patient has glaucoma in conjunction with cataract, which is the approved indication for the iStent. The patient is on maximal medical therapy for her glaucoma, and has shown advanced optic nerve cupping and visual field loss in both eyes.
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Overturned
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Experimental
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Summary Reviewer 2
A 68-year-old female enrollee has requested authorization and coverage for iStent placement (times two). 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 records support the superior efficacy of the services at issue. This patient has glaucoma in conjunction with cataract, which is the approved indication for the iStent. The patient is on maximal medical therapy for her glaucoma, and has shown advanced optic nerve cupping and visual field loss in both eyes. The use of the iStent for patients in this clinical setting has become the standard of care. Alternative treatment options, such as trabeculectomy or implantation of a tube shunt, are highly invasive and include the risk of serious vision-threatening complications. The data show that insertion of two stents provides better intraocular pressure control than one stent. Therefore, the iStent placement (times two) is likely to be of greater benefit than other treatment options. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
The patient is a 51-year-old female who developed neck and left shoulder pain after spending more time using a computer for work. The patient has requested reimbursement for physical therapy services provided from 2/15/21 through 5/05/21. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient.
this patient had been undergoing physical therapy for a long time, without documented significant functional benefit. Despite the therapy, she continued to have symptoms.
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Upheld
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Medical Necessity
|
Summary Reviewer
The patient is a 51-year-old female who developed neck and left shoulder pain after spending more time using a computer for work. The patient has requested reimbursement for physical therapy services provided from 2/15/21 through 5/05/21. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The physician reviewer found that this patient had been undergoing physical therapy for a long time, without documented significant functional benefit. Despite the therapy, she continued to have symptoms. The patient could have been transitioned to independent exercises or modalities that would have been expected to be no less effective for her condition than the ongoing physical therapy under review. There is no proven benefit of prolonged formal exercises or manual therapy for her conditions. The treatment of calcific tendinopathy revolves around analgesics such as nonsteroidal anti-inflammatory drugs (NSAIDs) and steroid injections in the painful acute phase and exercises to avoid stiffness of the shoulder. The treatment of frozen or stiff shoulder consists of addressing etiological factors, addressing pain to allow for range of motion, initiation of a gentle range of motion program, and progression of the program over time. Progression of the program does not require formal therapy. The current medical evidence does not support the services at issue in this clinical setting. Therefore, physical therapy services provided from 2/15/21 through 5/05/21 were not medically necessary for the treatment of this patient.
| 1 |
A 38-year-old male enrollee has requested authorization and coverage for suction assisted protein lipectomy. The Health Insurer has denied this request and reported that the requested services are not medically necessary for treatment of the enrollees lymphedema. The physician reviewer found the patient as longstanding lymphedema of the right lower extremity that has caused significant functional impairment as his condition has progressed. He complains of pain and difficulty with normal activity, including ambulation. He has undergone extensive conservative management of his condition, including complex congestive therapy with compression, bandaging and manual lymphatic drainage. He has also undergone medical management of his pain, chiropractic treatment, acupuncture and physical therapy. This has failed to treat his condition. The photographs are supportive of his documented enlarged right lower extremity.
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Overturned
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Medical Necessity
|
Summary Reviewer
A 38-year-old male enrollee has requested authorization and coverage for suction assisted protein lipectomy. The Health Insurer has denied this request and reported that the requested services are not medically necessary for treatment of the enrollees lymphedema. The physician reviewer found the patient as longstanding lymphedema of the right lower extremity that has caused significant functional impairment as his condition has progressed. He complains of pain and difficulty with normal activity, including ambulation. He has undergone extensive conservative management of his condition, including complex congestive therapy with compression, bandaging and manual lymphatic drainage. He has also undergone medical management of his pain, chiropractic treatment, acupuncture and physical therapy. This has failed to treat his condition. The photographs are supportive of his documented enlarged right lower extremity. Liposuction is a well-known therapy for lipodystrophy and has been shown to provide possible functional improvement in lymphedema. This patient has failed nonoperative current standard of care management. Lymphedema liposuction is a procedure that can likely improve his current condition. Thus, the requested suction assisted protein lipectomy is medically necessary for the treatment of this patient. Therefore, the requested services are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 61-year-old female enrollee has requested reimbursement for Botox injections provided on 12/13/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees low back pain and spasms.
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Upheld
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Experimental
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Summary Reviewer 2
A 61-year-old female enrollee has requested reimbursement for Botox injections provided on 12/13/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees low back pain and spasms. The physician reviewer found that there is currently insufficient scientific evidence demonstrating the effectiveness of botulinum toxin in the treatment of back pain. There is a lack of high-quality studies evaluating botulinum neurotoxin injections for patients with low back pain. Among the studies that exist, there is significant heterogeneity in trial design and outcome parameters. The current body of evidence does not support the use of Botox injections to improve pain or function in patients with low back pain. There is only low-quality evidence that Botox injections are more effective than saline or corticosteroid injections or acupuncture for reducing low back pain. The present literature has yet to address the long-term benefits of Botox injections in this setting. In sum, Botox injections provided on 12/13/17 was not likely to have been of greater benefit than other treatment options. 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 |
A 39-year-old male enrollee has requested authorization and coverage for hypoglossal nerve stimulation or Inspire Upper Airway Stimulation System. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees obstructive sleep apnea.
This patient has undergone surgical intervention but still has documented intolerance of CPAP therapy.
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Overturned
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Experimental
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Summary Reviewer 3
A 39-year-old male enrollee has requested authorization and coverage for hypoglossal nerve stimulation or Inspire Upper Airway Stimulation System. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees obstructive sleep apnea. The physician reviewer found that there is sufficient support for the requested services in this clinical setting. This patient has undergone surgical intervention but still has documented intolerance of CPAP therapy. Based on the records, he does meet criteria for consideration of hypoglossal nerve stimulation. Hypoglossal nerve stimulation therapy has been proven to be an effective modality for the treatment of obstructive sleep apnea in patients with tongue-based obstruction. Thus, hypoglossal nerve stimulation or Inspire Upper Airway Stimulation System is likely to be more effective than other treatment options. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
patient is a 60-year-old female with osteoporosis. She has had a suboptimal response to Actonel, Forteo and Evista.
This patient has failed therapy with multiple other agents in the past.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 60-year-old female with osteoporosis. She has had a suboptimal response to Actonel, Forteo and Evista. The physician reviewer found that Osteoporosis is an increasingly widespread condition, and fractures are the most dangerous aspect of osteoporosis. This can lead to acute and chronic pain. A newer medication, denosumab (Prolia) is a fully human monoclonal antibody which has been approved for the treatment of osteoporosis, treatment-induced bone loss, bone metastases, multiple myeloma, and giant cell tumor of bone. Prolia is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy. This patient has failed therapy with multiple other agents in the past. There is sufficient support for the medication at issue in this setting. Therefore, Prolia provided on 3/20/18, 10/15/18, 5/10/19 and 12/16/19 was medically necessary for the treatment of this patient.
| 1 |
The patient is a 40-year-old female with low back pain and right L5 and S1 radiculopathy. She is status post decompression and fusion at L5-S1 with pedicle screw fixation.
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Overturned
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Medical Necessity
|
Summary Reviewer
The patient is a 40-year-old female with low back pain and right L5 and S1 radiculopathy. She is status post decompression and fusion at L5-S1 with pedicle screw fixation. The physician reviewer found that the requested laminectomy, facetectomy and foraminotomy are medically necessary for the treatment of this patient.
| 1 |
patient is a 20-year-old male without a significant past medical history who presented to the emergency room with complaints of bilateral arm pain after lifting weights. He presented from an urgent care. At the time of presentation to the emergency department, his vital signs were stable.
at the time of admission, the patient was hemodynamically stable and afebrile with normal oxygen saturations on room air. He was diagnosed with rhabdomyolysis without acute kidney injury or any significant electrolyte disturbances.
|
Upheld
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Medical Necessity
|
Summary Reviewer
The patient is a 20-year-old male without a significant past medical history who presented to the emergency room with complaints of bilateral arm pain after lifting weights. He presented from an urgent care. At the time of presentation to the emergency department, his vital signs were stable. The physician reviewer found that at the time of admission, the patient was hemodynamically stable and afebrile with normal oxygen saturations on room air. He was diagnosed with rhabdomyolysis without acute kidney injury or any significant electrolyte disturbances. The inpatient admission was not medically necessary for this patient. Inpatient care is necessary when the patientas signs and symptoms and general medical condition can only be managed safely in an acute inpatient setting, when the patient requires diagnostic studies in an inpatient setting, or if it is medically necessary for the patient to remain in the acute inpatient setting. In this case, the patient was admitted in stable condition and could have been treated at a lower level of care. Therefore, inpatient admission provided from 9/23/19 through 9/26/19 was not medically necessary for the treatment of this patient.
| 1 |
A 44-year-old female enrollee has requested reimbursement for an AmniSure test that was performed on 4/7/14. The Health Insurer has denied this request indicating that the test at issue is considered investigational for evaluation of the rupture of the fetal membrane.
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Upheld
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Experimental
|
Summary Reviewer 3
A 44-year-old female enrollee has requested reimbursement for an AmniSure test that was performed on 4/7/14. The Health Insurer has denied this request indicating that the test at issue is considered investigational for evaluation of the rupture of the fetal membrane. The physician reviewer found that at issue in this case is whether the AmniSure test was a better tool to evaluate this patients leakage of fluid than any other standard available test, such as a traditional speculum exam with PH and microscopic evaluation of the fluid. The diagnosis of rupture of membranes (ROM) is made based upon patient history and clinical exam including a speculum evaluation of the vagina and cervix. Typically, the patient history, with a description of leakage of fluid, can help to rule in or rule out the diagnosis. This coupled with a sterile speculum exam to evaluate vaginal/cervical secretions (pooling), to evaluate the PH of any secretions, and to perform a microscopic examination for cervical ferning are used to complete the exam. In this case, there was no documentation of any sterile speculum/pelvic exam. A complete speculum exam would allow for better evaluation of any vaginal fluid to help determine if vaginal pooling occurred or to gather a specimen for evaluation of cervical ferning. For these reasons, the AmniSure test used to evaluate for ROM was not likely to be more beneficial than the standard tests available. Based upon the information set forth above, the test at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 59-year-old male enrollee has requested reimbursement for magnetic resonance imaging of the knee provided on 12/03/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition.
case, there was a history of significant trauma to the knee resulting from the large dog running into the knee. This had resulted
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Overturned
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Medical Necessity
|
Summary Reviewer
A 59-year-old male enrollee has requested reimbursement for magnetic resonance imaging of the knee provided on 12/03/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that total knee replacement is a relatively common successful procedure for pain relief and functional restoration in patients with advanced osteoarthritis. The key to long-term success in both primary and revision total knee arthroplasty is stability, as well as adequate and stable fixation between components and underlying bone. As ligamentous balancing is the key to success, it is necessary to know if a pre-operative trauma has resulted in ligamentous disruption, particularly of the medial or lateral collateral ligament, in order to decide if a posterior stabilized or a more constrained implant will be required. In this case, there was a history of significant trauma to the knee resulting from the large dog running into the knee. This had resulted in pain, swelling, and instability. As such, it was necessary to find out the cause of the reported instability before the surgery. Therefore, the surgeon found it necessary to obtain an MRI scan to evaluate the ligaments prior to the surgical procedure. There is sufficient support for the services at issue in this clinical setting. Therefore, magnetic resonance imaging of the knee performed on 12/03/19 was medically necessary for the evaluation of this patient.
| 1 |
A 37-year-old female has requested authorization and coverage for Gammagard liquid 10% vial. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollee, who has a history of recurrent pregnancy loss.
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Upheld
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Experimental
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Summary Reviewer 3
A 37-year-old female has requested authorization and coverage for Gammagard liquid 10% vial. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollee, who has a history of recurrent pregnancy loss. The physician reviewer found that IVIG treatment has been proposed as a treatment for the diagnosis of recurrent miscarriage due to immunologic causes. The etiologies for recurrent miscarriage may include chromosomal, uterine structural, ovulatory and immune factors or combinations of these factors. The treatments for immune factors, and especially their efficacy, are currently highly controversial when assessed for the standard of care. IVIG is one of these proposed treatments. Although a few early non-randomized, uncontrolled studies may have shown modest benefit in properly characterized patients with repeated pregnancy loss, most others that have used randomized controlled methods have not. Thus, there is no clear efficacy as yet shown per the current literature. The American Society for Reproductive Medicine, in its Practice Bulletin, stated treatment with IVIG has also been proposed for unexplained pregnancy loss. However, several trials and meta-analyses concluded that IVIG is ineffective for primary recurrent pregnancy loss; thus, this treatment is not recommended. Thus, the requested Gammagard liquid 10% vial is not likely to be more effective than other treatment options. Based upon the information set forth above, the requested medication is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 62-year-old male enrollee has requested reimbursement for blood test (protein biomarker tests or 4Kscore) provided on 10/29/18. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees risk for developing metastases.
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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 reimbursement for blood test (protein biomarker tests or 4Kscore) provided on 10/29/18. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees risk for developing metastases. The physician reviewer found that the 4Kscore test is a blood test which may be used to calculate an individual patients percent risk for aggressive prostate cancer on prostate biopsy. The 4Kscore test is intended to be used for patients with an abnormal prostate-specific antigen (PSA) and/or abnormal digital rectal examination who are being considered for initial or repeat prostate biopsy to identify the risk of high-grade prostate cancer. The test results provide percent risk for detecting high-grade prostate cancer on subsequent biopsy. The National Comprehensive Cancer Network guidelines recommend consideration of 4Kscore test for patients with prostate-specific antigen (PSA) levels greater than 3 ng/mL who have not yet had a biopsy. While 4Kscore may eventually have a role in reducing unnecessary biopsies, there are insufficient data on clinical outcomes to currently support routine use in screening men for prostate cancer. Hence, use of 4Kscore is not considered a clinically appropriate and generally accepted standard of care in routine screening for prostate cancer in men. The value of 4Kscore testing in men with prostate nodularity is largely unknown. In sum, the blood test (protein biomarker tests or 4Kscore) performed on 10/29/18 was not likely to have been of greater benefit than other methods of evaluating this patient.
| 0 |
A 52-year-old male enrollee has requested reimbursement for gene testing (gene expression profiling) performed on 10/31/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 3
A 52-year-old male enrollee has requested reimbursement for gene testing (gene expression profiling) performed on 10/31/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that melanoma is a cancer that is curable in its earliest stages. Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76 to 1.0 mm. Metastases to regional lymph nodes may be amenable to excision, but this suggests a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha. The data on DecisionDx-Melanoma testing has not made it part of routine analysis after sentinel lymph node biopsy. There has been some lack of consistency between various genes being used as biomarkers. As such, the test is novel, and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. Thus, gene testing (gene expression profiling) performed on 10/31/18 was not likely to have been more beneficial than other methods of evaluating this patient.
| 0 |
A 62-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 8/02/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic.
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Overturned
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Experimental
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Summary Reviewer 1
A 62-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 8/02/16. 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 the medical evidence supports the service at issue in this clinical setting. Breast tomosynthesis provides advantages to radiologists interpreting mammograms. This tomographic method often allows the reader to separate dense glandular elements from underlying mass/architectural distortion, resulting in a decrease in callbacks and increase in overall diagnostic accuracy and detection of small cancers compared to two-dimensional imaging alone. Thus, the addition of tomosynthesis to the usual two-dimensional protocol was likely of greater benefit to the patient than had her examination been done with two-dimensional imaging alone. Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 33-year-old male enrollee has requested authorization and coverage for Epidiolex 100 mg/mL solution. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for the treatment of the enrollees medical condition.
The patient has been on multiple anti-epileptic medications, including Keppra, gabapentin and Lamictal. He continues to demonstrate seizure activity.
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Overturned
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Medical Necessity
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Summary Reviewer
A 33-year-old male enrollee has requested authorization and coverage for Epidiolex 100 mg/mL solution. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the medical necessity of the requested medication. The patient has been on multiple anti-epileptic medications, including Keppra, gabapentin and Lamictal. He continues to demonstrate seizure activity. In cases where patients are refractory to traditional therapies, the use of cannabidiol has demonstrated significant benefit in controlling seizure activity. As this patient has not responded to traditional therapies, the use of Epidiolex is medically appropriate. Therefore, Epidiolex 100 mg/mL solution is medically necessary for the treatment of this patient.
| 1 |
A 38-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 7/13/15. 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 1
A 38-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 7/13/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found there is sufficient support for the services at issue in this clinical setting. 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. Ciatto and colleagues noted that integrated two-dimensional and three-dimensional mammography improves breast cancer detection and has the potential to reduce false positive recalls. The medical literature supports the use of breast tomosynthesis over conventional mammogram due to improved cancer detection rate. All told, breast tomosynthesis performed on 7/13/15 was likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 0 |
The 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.
that the patient reported several symptoms consistent with
autonomic dysfunction including positional dizziness, balance problems, urinary incontinence,
skin changes, and others. In addition, in this case, the patient had skin color changes and other
symptoms, such as swelling and burning pain,
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Overturned
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Experimental
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Summary Reviewer 3
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 patient reported several symptoms consistent with
autonomic dysfunction including positional dizziness, balance problems, urinary incontinence,
skin changes, and others. In addition, in this case, the patient had skin color changes and other
symptoms, such as swelling and burning pain, that could be consistent with a small fiber
neuropathy. The spectrum of disorders that can lead to this presentation is broad and includes
disorders in the POTS spectrum, including POTS or orthostatic intolerance to disorders caused
by autonomic failure, including small fiber neuropathies, degenerative neurological disorders or
innate central disorders of autonomic dysregulation. Per current standards of care, autonomic
reflex testing may be indicated. Testing includes tilt table testing, which stresses the bodys
autonomic vascular systems. In addition, small fiber tests, such as quantitative sudomotor axon
reflex test (QSART) or quantitative axon reflex sweat test (QSWEAT) may be performed to
determine if there is autonomic failure due to neuropathies. Axon-reflex-based small fiber test
of sudomotor, vasomotor, and pilomotor function is a well described test for evaluation of
post-ganglionic function in cases where there is a suspicion of such dysfunction. Though it is
not widely used outside of specialized centers (due to technical demands), it is currently
considered a standard of care test. Autonomic reflex testing is considered a standard of care for
patients with autonomic symptoms. There is no other effective way of evaluating for and
diagnosing certain autonomic disorders. Therefore, autonomic testing performed on 8/19/20
was likely to have been more beneficial than any available standard therapy.
| 1 |
A 60-year-old male enrollee has requested authorization and coverage for 18F-NaF positron emission tomography/computed tomography (PET/CT) scan. The Health Insurer has denied this request indicating that the requested diagnostic procedure is considered investigational for evaluation of the enrollees prostate cancer.
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Overturned
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Experimental
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Summary Reviewer 1
A 60-year-old male enrollee has requested authorization and coverage for 18F-NaF positron emission tomography/computed tomography (PET/CT) scan. The Health Insurer has denied this request indicating that the requested diagnostic procedure is considered investigational for evaluation of the enrollees prostate cancer. The physician reviewer found that based upon the recommendations of the National Oncologic PET Registry, the Centers for Medicare and Medicaid Services (CMS) revised its guidelines concerning coverage for PET scans in patients with solid tumors allowing up to three scans in each patient for diagnosis, staging and surveillance. While the use of this compound has proven to be of use in prostate cancer, the re-approval of 18F-NaF as a pharmaceutical has proven of greater benefit to patients with rising PSA levels where bone metastases are possible. The reason is the proven marked increased sensitivity of the technique compared to standard technetium bone scans in the detection and localization of skeletal metastatic deposits. In this patient with a rising PSA after radical prostatectomy, the possibility of subtle skeletal metastatic disease is possible and the requested 18F-NaF PET/CT scan is the most sensitive means with which to evaluate this patient. Based upon the information set forth above, I have determined the requested diagnostic procedure is likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 59-year-old male enrollee has requested authorization and coverage for Testim (testosterone gel 1%). The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hypogonadism.
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Overturned
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Medical Necessity
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Summary Reviewer
A 59-year-old male enrollee has requested authorization and coverage for Testim (testosterone gel 1%). The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hypogonadism. The physician reviewer found that low testosterone can lead to complications including reduced libido, erectile dysfunction, reduced muscle mass and strength, increased adiposity, osteoporosis, depressed mood and fatigue (Dandona and Rosenberg). For these reasons, many providers treat patients with hypogonadism when their testosterone level is less than 350 ng/dL (Nieschlag, et al). The general target level for testosterone ranges from 350 to 750 ng/dL, which is the range for healthy, androgen-sufficient adult men. Testosterone levels should be monitored three to six months after initiation of treatment in order to assure that the patients testosterone level is optimal and the dose of testosterone replacement therapy should be adjusted accordingly (Rivas, et al). Given these findings, the requested Testim (testosterone gel 1%) is medically necessary for treatment of this patients hypogonadism. Based on the foregoing discussion, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 30-year-old male enrollee has requested reimbursement for partial hospitalization program (PHP) chemical dependency services provided from 11/24/15 through 12/8/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees polysubstance abuse and bipolar disorder.
urine drug screening. On 12/3/15, the provider discontinued Abilify, leaving him on Seroquel and Paxil 37.5 mg. The records suggest the patient was psychiatrically stable as group therapy notes state that he was able to participate, concentrate, and maintain appropriate behavior, and there was no indication of medical instability.
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Upheld
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Medical Necessity
|
Summary Reviewer
A 30-year-old male enrollee has requested reimbursement for partial hospitalization program (PHP) chemical dependency services provided from 11/24/15 through 12/8/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees polysubstance abuse and bipolar disorder. The physician reviewer found that this patients records do not include an admitting psychiatric or psychosocial evaluation with description of the patients social and sober support. In addition, there is no mental status examination or urine drug screening. On 12/3/15, the provider discontinued Abilify, leaving him on Seroquel and Paxil 37.5 mg. The records suggest the patient was psychiatrically stable as group therapy notes state that he was able to participate, concentrate, and maintain appropriate behavior, and there was no indication of medical instability. Overall, there is limited information regarding patients substance abuse or bipolar diagnoses. According to the American Psychiatric Association (APA) guidelines, the PHP chemical dependency services provided from 11/24/15 through 12/8/15 were not medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 47-year-old male enrollee has requested authorization and coverage for Dupixent (dupilumab). The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees atopic dermatitis.
This patient has a chronic history of moderate to severe atopic dermatitis which has been unresponsive to treatment with numerous medium to
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Overturned
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Medical Necessity
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Summary Reviewer
A 47-year-old male enrollee has requested authorization and coverage for Dupixent (dupilumab). The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees atopic dermatitis. The physician reviewer found that the submitted documentation supports the medical necessity of the requested medication. This patient has a chronic history of moderate to severe atopic dermatitis which has been unresponsive to treatment with numerous medium to ultrapotent topical steroids, topical immunomodulators and intramuscular steroids. Dupixent is a U.S. Food and Drug Administration (FDA) approved injectable biologic for the treatment of moderate to severe atopic dermatitis. Given that the patient has had a lifelong history of moderate to severe atopic dermatitis and has failed management with topical and systemic steroids as well as topical immune modulators, Dupixent is medically appropriate. The long-term risks of continued use of topical or systemic steroids has been well-established. Thus, Dupixent (dupilumab) is medically necessary 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 |
The patient is a 54-year-old female who was diagnosed with a high-grade triple negative left-sided breast cancer. The patient has requested authorization and coverage for proton beam therapy. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient.
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Upheld
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Medical Necessity
|
Summary Reviewer
The patient is a 54-year-old female who was diagnosed with a high-grade triple negative left-sided breast cancer. The patient has requested authorization and coverage for proton beam therapy. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. The physician reviewer found that guidelines do not endorse the routine use of proton therapy in the treatment of breast cancer. There is a lack of data to suggest that proton beam therapy would be beneficial in this case or that it would be associated with less side effects than standard treatment with photons. The standard treatment in this case would be with chemotherapy, followed by surgery, followed by radiation with photons. Furthermore, consensus group guidelines do not support the use of proton therapy in this setting. In the vast majority of cases, intensity modulated radiation or three-dimensional conformal techniques with photons is able to achieve an acceptable cardiac and lung dose. Furthermore, treatments using deep inspiratory breath hold, which move the heart away from the chest wall, are also associated with very low cardiac doses in patients receiving radiation for breast cancer. In this case, although the comparison planning shows lower heart and lung doses with the proton plan, the standard plan with photons is not representative of typical cardiac or lung doses with intensity modulation or breath hold techniques. There is a lack of level I evidence to support the use of proton therapy for the treatment of breast cancer. Therefore, the requested proton beam therapy is not medically necessary for the treatment of this patient.
| 1 |
A 27-year-old male enrollee has requested reimbursement and prospective authorization and coverage for continued sub-acute inpatient care from 7/26/17 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 enrollee who is diagnosed with a brain injury.T
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Overturned
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Medical Necessity
|
Summary Reviewer
A 27-year-old male enrollee has requested reimbursement and prospective authorization and coverage for continued sub-acute inpatient care from 7/26/17 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 enrollee who is diagnosed with a brain injury.The physician reviewer found there is support for the services at issue in this clinical setting. The documented therapy and physician notes show that there has been improvement in this patients clinical status during his time at sub-acute inpatient care facility. Specifically, the documentation reports improvements in standing, heel to floor distance, tracking, head control, increased wheelchair tolerance, development of spontaneous swallowing, and command following. Despite his traumatic brain injury, this patients young age and overall good health are positive prognosticators. Taking into account the documented improvement in the patients medical status with the therapy he is receiving and his positive prognosticators, the services at issue were and are medically necessary for the treatment of his medical condition. Therefore, continued sub-acute inpatient care from 7/26/17 forward was and is medically necessary for the treatment of this patients medical condition.
| 0 |
A 53-year-old female enrollee has requested reimbursement for OVA1 testing performed on 5/19/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the patient was seen for postmenopausal bleeding, and an ultrasound showed an incidental 1.3 cm simple ovarian cyst.
. Her provider recommended surgery for the bleeding. In this case, no surgery was indicated for the cyst, and none was planned.
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Upheld
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Experimental
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Summary Reviewer 3
A 53-year-old female enrollee has requested reimbursement for OVA1 testing performed on 5/19/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the patient was seen for postmenopausal bleeding, and an ultrasound showed an incidental 1.3 cm simple ovarian cyst. Simple ovarian cysts, especially when this small, are common, even in early menopause, and considered functional, which means they come and go. This one was actually smaller than on a prior ultrasound. In this case, those findings made the likelihood of any ovarian pathology, and particularly ovarian cancer, very low. Her provider recommended surgery for the bleeding. In this case, no surgery was indicated for the cyst, and none was planned. The use of OVA1 has been approved for a very narrow indication, to determine whether a patient should be referred to a gynecologic oncologist for ovarian surgery that is already planned so that appropriate staging and surgical management can take place if ovarian cancer is found. This patient had a simple small ovarian cyst with no indication of possible ovarian cancer, and no surgery was planned or indicated for the cyst. The use of OVA1 was not appropriate based on current standards, and was not needed to assist with her clinical management. Thus, OVA1 testing performed on 5/19/15 was not likely to have been superior over 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 |
An 18-year-old male has requested reimbursement for Anser IFX testing performed on 7/09/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease.
This patient was losing response to the biologic treatment.
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Upheld
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Experimental
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Summary Reviewer 1
An 18-year-old male has requested reimbursement for Anser IFX testing performed on 7/09/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found there is sufficient support for the services at issue in this clinical setting. This patient was losing response to the biologic treatment. Rather than empirically dose escalate the patient, the provider recommended Anser IFX testing. This testing determined that dose escalation would be futile. This allowed for a rapid switch to another more beneficial agent. In sum, Anser IFX testing provided on 7/09/15 was likely to have been superior over other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 51-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 5/23/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who reported bilateral breast tenderness.
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Overturned
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Experimental
|
Summary Reviewer 1
A 51-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 5/23/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who reported bilateral breast tenderness. The physician reviewer found there is sufficient support for the service at issue in this clinical setting. Skaane and colleagues noted the use of mammography plus tomosynthesis in a screening environment resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers. Ciatto and colleagues indicated integrated two-dimensional and three-dimensional mammography improves breast cancer detection and has the potential to reduce false positive recalls. The literature supports the use of breast tomosynthesis over conventional mammogram due to improved cancer detection rate. In sum, breast tomosynthesis performed on 5/23/16 was likely to have been of greater benefit than other methods of 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 52-year-old male enrollee has requested reimbursement for emergency room physician services provided on 6/19/17. The Health Insurer has denied this request indicating the services at issue were not required on an emergent basis.
The patient presented with an acute injury that was significantly complex that required emergent physician services. There was serious impairment of the lower lip that could affect his oral competence (dysfunction), additional bleeding from the transected labial artery and significant deformity of the lower lip, without emergent treatment.
the patient at risk for functional impairment of the mouth, bleeding and significant deformity.
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Overturned
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Medical Necessity
|
Summary Reviewer
A 52-year-old male enrollee has requested reimbursement for emergency room physician services provided on 6/19/17. The Health Insurer has denied this request indicating the services at issue were not required on an emergent basis. The physician reviewer found that at issue in this case is whether a prudent layperson in the patients circumstances would believe he or she was experiencing an emergency medical condition. California law defines an emergency medical condition as a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that the absence of immediate medical attention could reasonably be expected to result in any of the following: (1) Placing the patients health in serious jeopardy; (2) Serious impairment to bodily functions; (3) Serious dysfunction of any bodily organ or part. Review of the submitted documentation demonstrates that a prudent layperson would have sought immediate medical attention on the date in question. The patient presented with an acute injury that was significantly complex that required emergent physician services. There was serious impairment of the lower lip that could affect his oral competence (dysfunction), additional bleeding from the transected labial artery and significant deformity of the lower lip, without emergent treatment. Emergency room personnel did not have the expertise to sufficiently treat this patient and plastic surgery was consulted. Based on the documentation submitted for review, the patient was within an acute phase of injury and thus emergent closure was necessary. Further delaying treatment placed the patient at risk for functional impairment of the mouth, bleeding and significant deformity. Thus, the emergency room physician services provided on 6/19/17 met prudent layperson criteria for emergency care.
| 1 |
A 45-year-old male enrollee has requested authorization and coverage for radiofrequency ablation. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition.
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Upheld
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Experimental
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Summary Reviewer 2
A 45-year-old male enrollee has requested authorization and coverage for radiofrequency ablation. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. At issue is whether the requested services are likely to be more beneficial for treatment of the enrollee's condition than any available standard therapy. The physician reviewer found that King and colleagues noted, aThe literature on sacral lateral branch interventions is sparse. One study demonstrates the face validity of multisite, multi-depth sacral lateral branch blocks for diagnosis of posterior sacroiliac complex pain. Some evidence of moderate quality exists on therapeutic procedures, but it is insufficient to determine the indications and effectiveness of sacral lateral branch thermal radiofrequency neurotomy, and more research is required.a Aydin and colleagues noted, aThe meta-analysis demonstrated that radiofrequency ablation is an effective treatment for sacroiliac joint pain at 3 months and 6 months. This study is limited by the available literature and lack of randomized controlled trials. Further standardization of RFA lesion techniques needs to be established, coupled with prospective randomized controlled trials.a This patient was being treated for chronic low back pain, lumbar spondylosis with radiculopathy, and sacroiliitis. He presented on 9/28/21 reporting almost complete relief of his low back pain from the sacroiliac joint injection on 6/18/21; however, the pain returned about two weeks after the injection, and gradually became severe again. He has current complaints of persistent pain in the left low back. The pain remains severe at 8/10, requiring him to continue to take medications. Examination reveals mild restriction of flexion and extension. There is tenderness to palpation at the lower lumbar levels spinous processes, and left paraspinal and gluteal musculature. There is moderate tenderness to palpation of the left posterior superior iliac spine. There is a positive left FABER test, thigh thrust and compressive tests. Strength testing reveals weakness of the left dorsiflexor at 4/5. Magnetic resonance imaging (MRI) is noted from 8/26/21 to show no change from prior examination on 4/29/19; interval spinal fusion at L5-S1. However, there is limited published, large-scale, long-term peer-reviewed literature that shows the request to be an effective and/or safe treatment for the noted pathology. There has been no literature consensus on which nerves are most appropriate to lesion. In addition, multiple other plausible pain generators (including at the lumbosacral spine) are evident. Therefore, the requested radiofrequency ablation is not likely to be more beneficial for treatment of the patient than any available standard therapy.
| 0 |
A 40-year-old female enrollee has requested reimbursement for CPT code 31299 performed on 12/22/20. 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 has a history of nasal obstruction, septal deviation and turbinate hypertrophy. The patient had used nasal sprays in the past, with minimal improvement. Cryotherapy has been found to benefit patients with chronic nasal drainage.
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Overturned
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Experimental
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Summary Reviewer 1
A 40-year-old female enrollee has requested reimbursement for CPT code 31299 performed on 12/22/20. 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 current medical evidence supports the requested services in this clinical setting. The patient has a history of nasal obstruction, septal deviation and turbinate hypertrophy. The patient had used nasal sprays in the past, with minimal improvement. Cryotherapy has been found to benefit patients with chronic nasal drainage. Gerka Stuyt and colleagues performed a prospective single-arm trial of 24 adult patients at seven locations within a large health maintenance organization. The authors noted, aCryoablation of the posterior nasal nerve shows improvement in nasal symptoms over a one-year period and is consistent with other published data.a Ow and colleagues noted, aCryotherapy with the ClariFix device significantly and clinically improves rhinitis symptoms and quality of life that are durable through 24 months after treatment.a Therefore, CPT code 31299 performed on 12/22/20 was likely to have been more beneficial than other available standard therapy.
| 1 |
A 60-year-old female enrollee has requested authorization and coverage for prescription fenofibric capsules 135 mg, two pills daily. The Health Insurer has denied this request indicating that the requested medication dosage is not medically necessary for treatment of the enrollees medical condition.
the records provided, the patient presents with hyperlipidemia, intolerance to statin medication due to polyneuropathy, and treatment with fenofibric acid.
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Upheld
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Medical Necessity
|
Summary Reviewer
A 60-year-old female enrollee has requested authorization and coverage for prescription fenofibric capsules 135 mg, two pills daily. The Health Insurer has denied this request indicating that the requested medication dosage is not medically necessary for treatment of the enrollees medical condition. The physician reviewer found that the request medication dosage is not medically necessary for treatment of the patients medical condition. Based on the records provided, the patient presents with hyperlipidemia, intolerance to statin medication due to polyneuropathy, and treatment with fenofibric acid. In this circumstance, the recommended maximum dosage of fenofibric acid is 135 mg once daily, per prescribing information. Higher doses have not been adequately evaluated in the scientific literature. Moreover, the use of fibric acid derivatives is targeted mainly at treatment of high triglycerides and low HDL, neither of which are significantly present on the patients lipid profile while taking the current dose of fenofibric acid 135 mg one tablet daily. Current guidelines on the evaluation and management of dyslipidemia do not recommend fenofibric acid doses more than 135 mg once daily for the treatment of dyslipidemia. Therefore, fenofibric capsules 135 mg, twice daily is not medically necessary for treatment of the patients medical condition. Therefore, the requested medication dosage is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 42-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis provided on 1/19/16. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition.
In this case, the patient has breasts that have been described as being diffusely dense.
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Overturned
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Experimental
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Summary Reviewer 3
A 42-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis provided on 1/19/16. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that Tomosynthesis is a technique that was developed as a problem solving adjunct to routine mammography. In this case, the patient has breasts that have been described as being diffusely 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. Therefore, the breast tomosynthesis performed on 1/19/16 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 55-year-old female enrollee has requested authorization and coverage for arthrodesis of sacroiliac (SI) joint (27279). The Health Plan has denied this request indicating that the requested services are considered investigational for treatment of the enrollees SI joint pain.
In this case, the left SI joint has been demonstrated to be the pain generator. This was confirmed with a SI joint injection with associated pain relief.
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Upheld
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Experimental
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Summary Reviewer 2
A 55-year-old female enrollee has requested authorization and coverage for arthrodesis of sacroiliac (SI) joint (27279). The Health Plan has denied this request indicating that the requested services are considered investigational for treatment of the enrollees SI joint pain. The physician reviewer found that the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. SI joint syndrome can cause various symptoms and may be a reason for persistent low back pain, especially in patients with prior spinal fusions. If conservative treatments fail to improve symptoms, arthrodesis surgery can be considered. Minimally invasive approaches provide a good alternative to conventional methods. A triangular implant system can be used without bone grafting or screw fixation to achieve an optimal fusion of the SI joint. Minimally invasive surgical arthrodesis of the SI joint is known to result in significant improvement in pain and function. In this case, the left SI joint has been demonstrated to be the pain generator. This was confirmed with a SI joint injection with associated pain relief. For the reasons provided, the proposed minimally invasive surgical arthrodesis of SI joint (27279) is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 31-year-old female enrollee has requested authorization and coverage for Xifaxan. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees irritable bowel syndrome.
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Overturned
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Medical Necessity
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Summary Reviewer
A 31-year-old female enrollee has requested authorization and coverage for Xifaxan. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees irritable bowel syndrome. The physician reviewer found the review of the submitted documentation and relevant literature demonstrates the medical necessity for the requested medication. Xifaxan is approved by the U.S. Food and Drug Administration (FDA) for the treatment of IBS. According to the study by Pimentel and colleagues, Among patients without constipation, treatment with rifaximin for two weeks provided significant relief of bloating, abdominal pain, and loose or watery stools. In addition, both the American Gastroenterological Association guideline and the American College of Gastroenterology guideline reviewed the data on the randomized controlled trials for rifaximin, and found that there was moderate evidence that it was effective. In sum, Xifaxan is supported by evidence-based literature, and the medical necessity of the requested medication has been established in this patients case. For the reasons provided, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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A 60-year-old female enrollee has requested reimbursement for DecisionDX Melanoma gene expression assay performed on 12/23/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees cutaneous melanoma.
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Upheld
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Experimental
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Summary Reviewer 2
A 60-year-old female enrollee has requested reimbursement for DecisionDX Melanoma gene expression assay performed on 12/23/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found a commercial gene expression profile test (DecisionDX Melanoma gene expression assay has been developed in patients with stage I and II cutaneous melanoma. However, there are no definitive data regarding its use for risk classification in patients with cutaneous melanoma, and this test does not currently have a role in determining which patients are candidates for adjuvant immunotherapy, either as a standard of care or as part of clinical trials. The National Comprehensive Cancer Network (NCCN) Guidelines, recognize that there is growing interest in newer prognostic molecular techniques such as gene expression profiling to differentiate benign from malignant neoplasms, or melanomas at low versus high risk for metastasis. However, the routine (baseline) genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study (trial). Therefore, the DecisionDX Melanoma gene expression assay performed on 12/23/15 was not likely to be more efficacious than available standard therapy for evaluation of this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 20 year-old male enrollee has requested reimbursement for psychiatric acute inpatient treatment from 11/17/18 through 11/29/18. 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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Upheld
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Medical Necessity
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Summary Reviewer
A 20 year-old male enrollee has requested reimbursement for psychiatric acute inpatient treatment from 11/17/18 through 11/29/18. 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 cases such as this, an evidence-based, objective, instrument such as the American Association of Community Psychiatrists Level of Care Utilization System (LOCUS) is indispensable in determining necessary and appropriate level of care for adults. In terms of risk of harm, the records support a score of 3 due to a lack of current suicidal ideation but a history of this as his presenting issue. With regards to functional status, the records support a score of 2 due to overall good daily function while on the inpatient unit. In terms of medical, addictive and psychiatric comorbidity, the records support a score of 2 due to a history of substance use and commitment to sobriety as well as no active significant medical issues. With regards to level of stress of the recovery environment, the records support a score of 2 due to some apparent peer relationship issues. In terms of level of support of the recovery environment, the records support a score of 2 due to a sober living environment and support of parents. With regards to treatment and recovery history, the records support a score of 2 due to positive response to inpatient treatment. In terms of engagement and recovery status, the records support a score of 2 due to good cooperation in treatment and noted current insight into the need for treatment. Thus, the patient has a composite score of 15. This score correlates with community-based services. Therefore, psychiatric acute inpatient treatment from 11/17/18 through 11/29/18 was not medically necessary for the treatment of this patient.
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The patient is a 19-year-old female with recurrent headaches, lock jaw, body stiffness, dizziness, as well as complaints of numbness in her legs and feet. She was treated for possible Lyme disease per the documentation. Her symptoms persisted despite this treatment. The provider noted the patients presentation required further investigation for vector-borne disease and rheumatoid diseases. The patient has requested reimbursement for infectious agent detection by nucleic acid, multiple organisms; amplified probe(s) technique, infectious agent
, common variants testing provided on 7/5/17 and 9/19/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational.
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Upheld
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Experimental
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Summary Reviewer 3
The patient is a 19-year-old female with recurrent headaches, lock jaw, body stiffness, dizziness, as well as complaints of numbness in her legs and feet. She was treated for possible Lyme disease per the documentation. Her symptoms persisted despite this treatment. The provider noted the patients presentation required further investigation for vector-borne disease and rheumatoid diseases. The patient has requested reimbursement for infectious agent detection by nucleic acid, multiple organisms; amplified probe(s) technique, infectious agent detection by nucleic acid, not otherwise specified; amplified probe(s) technique, and each organism and methylenetetrahydrofolate reductase (MTHFR) inhibitor gene analysis, common variants testing provided on 7/5/17 and 9/19/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational. Standard testing is recommended by Centers for Disease Control and Prevention (CDC) guidelines for Lyme disease, Babesia and well as Bartonella (Moore, et al). The provider noted concern was for vector-borne illnesses. The sensitivity and specificity for standard testing is appropriate for this patients constellation of symptoms. Thus, additional evaluation with polymerase chain reaction (PCR) or MTHFR testing was not indicated. Accordingly, the infectious agent detection by nucleic acid, multiple organisms; amplified probe(s) technique, infectious agent detection by nucleic acid, not otherwise specified; amplified probe(s) technique, and each organism and MTHFR inhibitor gene analysis, common variants testing provided on 7/5/17 and 9/19/17 were not likely to be more beneficial for the evaluation of the patients medical condition as compared to standard approaches. 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 patient is a 16-year-old female with posttraumatic stress disorder (PTSD), as well as alcohol, cannabis, sedative/hypnotic/anxiolytic, psilocybin, and LSD use disorders, as well as a history of self-harm. The patientas parent has requested reimbursement and prospective authorization and coverage for intensive outpatient mental health treatment provided from 4/24/20 forward. The Health Insurer has denied this request and reported that the services at issue were not and are not medically necessary for the treatment of this patient.
. The patient had moderate functional impairment, due to interpersonal conflict with parents and struggles to focus during online school.
. The patient had significant comorbidity, due to recent substance use as well as post-traumatic stress disorder, with decline in substance use while participating
The patient had a mildly stressful environment, due to social isolation of shelter-in place, conflict with parents, struggles with school, and potential exposure to the sisteras substance use in the home.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 16-year-old female with posttraumatic stress disorder (PTSD), as well as alcohol, cannabis, sedative/hypnotic/anxiolytic, psilocybin, and LSD use disorders, as well as a history of self-harm. The patientas parent has requested reimbursement and prospective authorization and coverage for intensive outpatient mental health treatment provided from 4/24/20 forward. The Health Insurer has denied this request and reported that the services at issue were not and are not medically necessary for the treatment of this patient. The physician reviewer found that The Child and Adolescent Level of Care Utilization System (CALOCUS) provides a framework for determining the clinically appropriate level of care for a child or adolescent in mental health treatment. In terms of risk of harm, the records support a score of 3. The records noted significant risk of harm, due to continued self-harm, even after months of IOP treatment. With regard to functional status, the records support a score of 3. The patient had moderate functional impairment, due to interpersonal conflict with parents and struggles to focus during online school. In terms of comorbidity, the records support a score of 3. The patient had significant comorbidity, due to recent substance use as well as post-traumatic stress disorder, with decline in substance use while participating in the increased structure of the IOP. With regard to recovery environment, the records support a score of 2. The patient had a mildly stressful environment, due to social isolation of shelter-in place, conflict with parents, struggles with school, and potential exposure to the sisteras substance use in the home. Environmental support is scored at 2 due to the parentsa participation in treatment. In terms of resiliency and treatment history, the records support a score of 3. The patient was able to maintain abstinence from substance use while at the IOP. However, she has continued to struggle with trauma-related symptoms and self-harm. In terms of treatment acceptance and engagement, the records support a score of 2. The patient participated in treatment, with some struggles in fully implementing the strategies learned. Thus, the total CALOCUS score is 18. In this case, the recommended level of care is level three: high-intensity community-based services. This is consistent with the IOP level of care that patient has been receiving. Therefore, intensive outpatient mental health treatment provided from 4/24/20 forward was and is medically necessary for the treatment of this patient.
| 1 |
The patient is a 55-year-old male with a history of autoimmune hearing loss in the left ear. The patient was doing well with intermittent steroids. According to the medical records, the patient is becoming intolerant to steroids. He is having problems with shortness of breath. The patient tried treatment with the tumor necrosis factor (TNF) blocker Simponi with reported improvement in his hearing. The patient has requested authorization and coverage for Simponi 50 mg injections once per month for one year (J1602). The Health Insurer has denied this request indicating that the requested medication is considered investigational.
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Upheld
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Experimental
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Summary Reviewer 2
The patient is a 55-year-old male with a history of autoimmune hearing loss in the left ear. The patient was doing well with intermittent steroids. According to the medical records, the patient is becoming intolerant to steroids. He is having problems with shortness of breath. The patient tried treatment with the tumor necrosis factor (TNF) blocker Simponi with reported improvement in his hearing. The patient has requested authorization and coverage for Simponi 50 mg injections once per month for one year (J1602). The Health Insurer has denied this request indicating that the requested medication is considered investigational. Currently, the medical literature supports the use of steroids for treatment of autoimmune hearing loss. However, other medications, including TNF blockers and autoimmune agents, are not considered first-line therapies. The articles provided by the treating provider cite a five patient trial and admit further studies are needed. Moreover, the patients were not followed long enough for adequate assessment. Given these findings, the requested Simponi 50 mg injections once per month for one year (J1602) are 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 medication is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 57-year-old male enrollee has requested reimbursement for electromagnetic navigational bronchoscopy performed on 9/29/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees lung nodule.
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Overturned
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Experimental
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Summary Reviewer 3
A 57-year-old male enrollee has requested reimbursement for electromagnetic navigational bronchoscopy performed on 9/29/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees lung nodule. The physician reviewer found that electromagnetic navigational biopsy is a procedure which allows the provider to direct a biopsy forceps or brush with greater accuracy to sample lung nodules. Existing techniques, like a standard bronchial brush or biopsy, have a low yield for peripheral lesions. This patient had a peripheral lung lesion and hemoptysis. Computed tomography (CT) guided needle biopsy involves a risk of bleeding. The use of electromagnetic navigational localization allows the provider to sample a lesion with much more accuracy and safety than standard procedures. In sum, electromagnetic navigational bronchoscopy performed on 9/29/15 was likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 35-year-old female enrollee has requested reimbursement for homocysteine testing provided on 6/05/18 and 7/16/18. 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 miscarriage.
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Upheld
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Experimental
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Summary Reviewer 2
A 35-year-old female enrollee has requested reimbursement for homocysteine testing provided on 6/05/18 and 7/16/18. 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 miscarriage. The physician reviewer found that there is a lack of support for the services at issue in this clinical setting. The American College of Obstetricians and Gynecologists noted that testing for inherited thrombophilias in women who have experienced recurrent fetal loss or placental abruption is not recommended because it is unclear if anticoagulation therapy reduces recurrence. Although there may be an association in these cases, there is insufficient clinical evidence that antepartum prophylaxis with unfractionated heparin or low molecular weight heparin prevents recurrence in these patients. The only superseding issue would be if the patient had a personal history of venous thromboembolism or a first-degree relative with a history of high-risk thrombophilia. No such history is presented in this case. In sum, homocysteine testing provided on 6/05/18 and 7/16/18 was not likely to have been more effective than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
A 51-year-old female enrollee has requested reimbursement for the MammaPrint genetic test provided on 2/3/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees left breast carcinoma.
this patient already underwent genetic testing with OncotypeDX and was noted to have lymphovascular invasion.
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Upheld
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Experimental
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Summary Reviewer 2
A 51-year-old female enrollee has requested reimbursement for the MammaPrint genetic test provided on 2/3/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees left breast carcinoma. The physician reviewer found that in the peer-reviewed medical literature, there is inadequate data demonstrating that a high risk MammaPrint result is a reliable indication for chemotherapy. Further, there is currently a lack of data to support using MammaPrint testing in patients with intermediate OncotypeDX score. Although Cardoso and colleagues reported that MammaPrint has been shown to improve prediction of clinical outcome in women with early-stage breast cancer, this patient already underwent genetic testing with OncotypeDX and was noted to have lymphovascular invasion. Thus, additional genetic testing was not needed for decision making regarding adjuvant chemotherapy. All told, the MammaPrint genetic test provided on 2/3/16 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 57-year-old female requested reimbursement for magnetic resonance imaging (MRI) provided on 9/2/16.The Health Insurer has denied this request and reported that the service at issue was considered investigational for evaluation of the enrollee who has a history of breast cysts.
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Upheld
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Experimental
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Summary Reviewer 1
A 57-year-old female requested reimbursement for magnetic resonance imaging (MRI) provided on 9/2/16.The Health Insurer has denied this request and reported that the service at issue was considered investigational for evaluation of the enrollee who has a history of breast cysts. The physician reviewer found that there is support in the medical literature for the service at issue in this clinical setting. The positive family history, the dense tissue on mammography, and the presence of implants all limit the accuracy of mammography in this patient. MRI is the most sensitive means with which to screen for breast cancer and most patients with this risk level will undergo alternating MRI and mammography every six months. The use of MRI in this clinical setting has been advocated by many breast imaging organizations as well as the American Cancer Society. For these reasons, MRI performed on 9/2/16 was likely to be superior to other modalities available for the evaluation of 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 |
The patient is a 64-year-old female with a history of severe sleep apnea. The records document an apnea-hypopnea index of 43.0 per a sleep study dated 10/12/17. She had no central apneas. She has tried a continuous positive airway pressure (CPAP) device, but has not been able to tolerate it. She is status post septoplasty and turbinate reduction, without improvement. The patient has requested coverage for an implanted nerve stimulator. The Health Insurer has denied this request and reported that the requested device is investigational for the treatment of this patient. This patient has severe obstructive sleep apnea and has not been able to tolerate the CPAP device. She has undergone septoplasty and turbinate reduction, which has not improved her condition.
Her body mass index is below 32. This patient is a candidate for the Inspire
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Overturned
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Experimental
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Summary Reviewer 1
The patient is a 64-year-old female with a history of severe sleep apnea. The records document an apnea-hypopnea index of 43.0 per a sleep study dated 10/12/17. She had no central apneas. She has tried a continuous positive airway pressure (CPAP) device, but has not been able to tolerate it. She is status post septoplasty and turbinate reduction, without improvement. The patient has requested coverage for an implanted nerve stimulator. The Health Insurer has denied this request and reported that the requested device is investigational for the treatment of this patient. This patient has severe obstructive sleep apnea and has not been able to tolerate the CPAP device. She has undergone septoplasty and turbinate reduction, which has not improved her condition. The Inspire device is medically appropriate in this clinical setting. Her body mass index is below 32. This patient is a candidate for the Inspire device. Therefore, the implanted nerve stimulator is likely to be more efficacious than other treatment options in this patients case. 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 43-year-old female enrollee has requested reimbursement for the blood testing provided on 1/17/17. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees cardiovascular risk.
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Upheld
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Experimental
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Summary Reviewer 2
A 43-year-old female enrollee has requested reimbursement for the blood testing provided on 1/17/17. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees cardiovascular risk. The physician reviewer found that the use of the advanced lipoprotein testing with measurement of low density lipoprotein (LDL) cholesterol particle numbers remains controversial. While some providers have advocated for its use, the American College of Cardiology (ACC) guidelines do not support its use, recommending instead standard risk assessment protocols and standard lipid profile testing (Stone, et al). The ACC moved away from specific target goals of LDL in their most recent guidelines, based on review of outcome studies. Lloyd-Jones and colleagues provided an expert consensus update from the ACC and it does not mention the use of advanced lipid testing. Overall, the guidelines do not establish a strong recommendation for use of the advanced lipid profiles at this time. Thus, the blood testing provided on 1/17/17 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
The parent of a 13-year-old female enrollee has requested reimbursement for homocysteine testing performed on 12/31/15. The Health Insurer has denied this request indicating that the testing at issue was not medically necessary for evaluation of the enrollees behavioral health condition.
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Upheld
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Experimental
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Summary Reviewer 3
The parent of a 13-year-old female enrollee has requested reimbursement for homocysteine testing performed on 12/31/15. The Health Insurer has denied this request indicating that the testing at issue was not medically necessary for evaluation of the enrollees behavioral health condition. The physician reviewer found the homocysteine testing is not a standard therapy recognized for treatment of ADHD. While a study by Karababa and colleagues was aimed at evaluating the homocysteine levels and oxidative stress parameter in patients with ADHD, that study only involved 32 adult ADHD patients. Moreover, the study concluded that oxidative balance is not impaired in adult ADHD patients and homocysteine levels were found to be lower (Karababa et al). Due to the lack of peer-reviewed literature to support the use of this test in evaluating and treating the patients ADHD symptoms, the test at issue was not likely to be more beneficial than available standard therapies. The Health Insurers denial should be upheld.
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A 52-year-old male enrollee has requested reimbursement for a wearable cardioverter defibrillator provided on 1/24/19. The Health Insurer has denied this request indicating that the device at issue was investigational for the treatment of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 3
A 52-year-old male enrollee has requested reimbursement for a wearable cardioverter defibrillator provided on 1/24/19. The Health Insurer has denied this request indicating that the device at issue was investigational for the treatment of the enrollees medical condition. The physician reviewer found that documented high risk of sudden cardiac death in patients with severe left ventricular dysfunction has led to the recommendation of implantable cardioverter defibrillators in this group of patients. Current data from multiple trials and registries have advocated the use of a wearable cardioverter defibrillator after an initial diagnosis of severe left ventricular dysfunction with an ejection fraction of less than or equal to 35%. This patients ejection fraction was 25 to 30%. The recommended timing of a wearable cardioverter defibrillator placement based on guidelines from the American College of Cardiology/American Heart Association and the Heart Rhythm Society is within 40 days of an acute myocardial infarction or within 90 days of an initial diagnosis of congestive heart failure with a low ejection fraction. Therefore, the placement of the patients wearable cardioverter defibrillator on 1/24/19 falls within accepted guidelines. Thus, the wearable cardioverter defibrillator provided on 1/24/19 was likely to have been more effective than other treatment options.
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A 38-year-old female has requested reimbursement for laboratory testing performed on 7/06/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who had a history of recurrent pregnancy loss.
advanced age, her hypothyroidism, and the septate uterus. In fact, her age and likely a chromosomal issue accounted for the early first trimester loss, and the septum was likely the etiology of the second trimester loss. As part of her work-up the provider ordered a thrombophilia panel.
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Upheld
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Experimental
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Summary Reviewer 2
A 38-year-old female has requested reimbursement for laboratory testing performed on 7/06/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who had a history of recurrent pregnancy loss. The physician reviewer found the medical evidence does not support the superior effectiveness of the services at issue in this patients case. This is a situation where there were a number of possible reasons for this patients miscarriages, including her advanced age, her hypothyroidism, and the septate uterus. In fact, her age and likely a chromosomal issue accounted for the early first trimester loss, and the septum was likely the etiology of the second trimester loss. As part of her work-up the provider ordered a thrombophilia panel. The reason put forth was that this might be useful if the assessment for a uterine anomaly did not reveal a problem. However, current medical literature does not support such screening in a patient with a prior first and second trimester loss, such as in this case. In sum, the information from the panel was not likely to elucidate the cause of her pregnancy losses, nor would it change her future treatment. There were other diagnoses that likely contributed to the pregnancy losses. In sum, laboratory testing performed on 7/06/15 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 24-year-old female enrollee has requested authorization and coverage for molecular pathology laboratory testing. The Health Insurer has denied this request indicating that the requested testing is not medically necessary for evaluation of the enrollees autism spectrum disorder (ASD), developmental delays and epilepsy.
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Overturned
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Medical Necessity
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Summary Reviewer
A 24-year-old female enrollee has requested authorization and coverage for molecular pathology laboratory testing. The Health Insurer has denied this request indicating that the requested testing is not medically necessary for evaluation of the enrollees autism spectrum disorder (ASD), developmental delays and epilepsy. The physician reviewer found that according to the American College of Medical Genetics and Genomics (ACMG), whole genome/exome sequencing should be considered in the clinical diagnostic assessment of patients with a phenotype that is strongly associated with a genetic etiology. In this case, several first tier evaluations have been conducted and were non-diagnostic. Given the complex nature of the patients phenotype, physical presence of cafe au lait macules, and a concerning family history autism, whole exome/genome testing is the next logical step and is consistent with the standards of practice within the field of genetics. The combination of chromosomal microarray and whole exome/genome testing greatly increases the likelihood of a unifying diagnosis (Tammimies, et al). Given these findings, the requested molecular pathology laboratory testing is medically necessary for evaluation of this patients medical condition. Based on the foregoing discussion, the requested testing is medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 51-year-old male enrollee has requested reimbursement and prospective authorization and coverage for transcranial magnetic stimulation from 8/08/16 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health conditions.
One of his previous depressive episodes was likely brought on by methamphetamine abuse. There was
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Upheld
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Medical Necessity
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Summary Reviewer
A 51-year-old male enrollee has requested reimbursement and prospective authorization and coverage for transcranial magnetic stimulation from 8/08/16 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the services at issue. It is uncertain if this patients current symptoms are due to a substance induced mood disorder. One of his previous depressive episodes was likely brought on by methamphetamine abuse. There was no documentation of a negative urine drug screen. There is a lack of robust studies showing improvement in patients with major depressive disorder and comorbid posttraumatic stress disorder. Flory and Yehuda reported that patients with posttraumatic stress disorder and comorbid major depressive disorder have a high likelihood for poor response to treatment. The treatment recommendation for major depressive disorder with comorbid posttraumatic stress disorder is trauma-based psychotherapy. All told, transcranial magnetic stimulation from 8/08/16 forward was not and is not medically indicated for the treatment of this patient. Therefore, the services at issue were not and are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 57-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing provided on 8/30/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas melanoma.
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Upheld
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Experimental
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Summary Reviewer 3
A 57-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing provided on 8/30/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas 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 they suggest a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha. The data on DecisionDx-Melanoma testing has not made it part of routine analysis after sentinel lymph node biopsy. There has also been some lack of consistency between various genes being used as biomarkers. As such, the test is novel, and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. All told, DecisionDx-Melanoma testing provided on 8/30/19 was not likely to have been more beneficial than other methods of evaluating this patient.
| 0 |
The parent of a 12-year-old male enrollee has requested reimbursement for neuropsychological testing performed on 1/18/17. The Health Insurer has denied this request indicating that the testing at issue was not medically necessary for evaluation of the enrollees behavioral health issues.
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Upheld
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Medical Necessity
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Summary Reviewer
The parent of a 12-year-old male enrollee has requested reimbursement for neuropsychological testing performed on 1/18/17. The Health Insurer has denied this request indicating that the testing at issue was not medically necessary for evaluation of the enrollees behavioral health issues. The physician reviewer found that Neuropsychological testing was recommended in this case to aid with determining the patients diagnosis and clarifying depression. Per the American Psychiatric Association (APA), psychological and neuropsychological tests are not mandatory for the diagnosis of ADHD, but should be performed if the patients history suggests low general cognitive ability. The current standard of care for diagnosis of ADHD is through full clinical evaluation. In addition, Wolraich and colleagues noted that to make a diagnosis of ADHD, the primary care clinician should determine that Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria have been met. This patients records do not indicate that the patient had a low general cognitive ability or any other neurological deficits that would require further and more complex evaluation. This patient had a history of tics and memory problems. Tics are more common in children with anxiety and ADHD but do not necessitate any form of neuropsychological testing. The patients memory problems can be explained by a diagnosis of ADHD. The criteria listed in the patients intake assessment are consistent with the diagnostic criteria for ADHD and additional testing was therefore not indicated. In summary, the neuropsychological testing performed on 1/18/17 was not medically necessary for evaluation of this patients medical condition. Based on the foregoing, the testing at issue was not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
| 0 |
A 54-year-old female enrollee has requested authorization and coverage for positron emission tomography/computed tomography (PET/CT). The Health Insurer has denied this request indicating that the requested diagnostic procedure is considered investigational for evaluation of the enrollees left breast carcinoma.
is at high risk for recurrence of cancer and has not been able to take hormonal therapy.
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Overturned
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Experimental
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Summary Reviewer 3
A 54-year-old female enrollee has requested authorization and coverage for positron emission tomography/computed tomography (PET/CT). The Health Insurer has denied this request indicating that the requested diagnostic procedure is considered investigational for evaluation of the enrollees left breast carcinoma. The physician reviewer found that PET scanning involves a determination of the uptake of radioactive glucose in bodily tissues. There is abnormally increased uptake in a variety of tissues including cancer and inflammation as well as post-operative healing. There is adequate medical literature supporting the role of PET/CT in this clinical setting. This patient is at high risk for recurrence of cancer and has not been able to take hormonal therapy. Since the area of concern has been noted to be too small to appropriately biopsy, the requested PET/CT scan is likely to be more beneficial for evaluation and treatment of this patients breast cancer than any other available modality. Based upon the information set forth above, I have determined the requested diagnostic procedure is 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 50-year-old female enrollee has requested authorization and coverage for ultrasound ablation. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees uterine fibroids.
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Upheld
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Experimental
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Summary Reviewer 3
A 50-year-old female enrollee has requested authorization and coverage for ultrasound ablation. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees uterine fibroids. The physician reviewer found that symptomatic uterine fibroids are a fairly common medical condition, and standard and definitive therapy for a patient with these clinical demographics is hysterectomy. There is increasing data to support the use of MR-guided focused ultrasound for treatment of uterine fibroids (Ikink, et al). However, there is limited information of the long-term comparative effectiveness in relation to the numerous additional therapeutic options available. In addition to the patients largest fibroid, there are still at least two other sizable submucosal fibroids that would remain. In this clinical setting, ultrasound ablation is not likely to be more beneficial for treatment of the patients medical condition than other standard options. 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 |
The parent of a 12-year-old female enrollee has requested reimbursement and prospective authorization and coverage for residential mental health treatment services from 7/1/15 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 behavioral health condition.
The patient presents with a complex mental health history which is complicated by loss of parents at an early age, living in an orphanage and international adoption. The patient has been diagnosed with major depressive disorder, dysthymic disorder (pervasive depressive disorder) and disruptive mood dysregulation disorder, which are potentially treatable with psychopharmacology. In this case, the patient has had a trial of Zoloft and Trileptal and is currently taking Lamictal.
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Upheld
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Medical Necessity
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Summary Reviewer
The parent of a 12-year-old female enrollee has requested reimbursement and prospective authorization and coverage for residential mental health treatment services from 7/1/15 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 behavioral health condition. The physician reviewer found the residential treatment services provided from 7/1/15 forward were not and are not medically necessary for treatment of the patients medical condition. The patient presents with a complex mental health history which is complicated by loss of parents at an early age, living in an orphanage and international adoption. The patient has been diagnosed with major depressive disorder, dysthymic disorder (pervasive depressive disorder) and disruptive mood dysregulation disorder, which are potentially treatable with psychopharmacology. In this case, the patient has had a trial of Zoloft and Trileptal and is currently taking Lamictal. Given that the patient presents with treatable mental health conditions, psychopharmacological intervention needs to be more intensive. In addition, the primary focus of RAD related disorder is corrective emotional experience and intensive and dynamic family therapy. By placing the patient out of state, this aspect of the intervention is significantly comprised. In this clinical setting based on all of the documentation presented for review, the patient can be safely and effectively managed at a lower level of care in a less restrictive setting. Therefore, the services at issue were not and are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 57-year-old male insured has requested reimbursement for a gene test (CPT 0047U) provided on
3/10/22. The Health Insurer has denied this request indicating that the services at issue were considered
investigational for the evaluation of the insureds prostate cancer.
biopsy of the prostate demonstrated Gleason
3+3=6 prostate cancer with a PSA of 7.7
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Overturned
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Experimental
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Summary Reviewer 3 A 57-year-old male insured has requested reimbursement for a gene test (CPT 0047U) provided on
3/10/22. The Health Insurer has denied this request indicating that the services at issue were considered
investigational for the evaluation of the insureds prostate cancer. The physician reviewer found that
Oncotype DX genomic prostate score testing has been used to predict higher-grade disease in patients
undergoing active surveillance. Many studies suggest that Oncotype DX can predict higher-grade
pathologic features in patients undergoing active surveillance and can help guide shared decision-
making for very low-risk or intermediate-risk prostate cancer. According to the current medical
literature, the addition of Oncotype DX can provide important risk information about how an individual
tumor will likely behave and help direct treatment. The recommendations for patients with localized,
locally advanced, post-radical prostatectomy and recurrent prostate cancer are based on prognosis,
which is estimated through risk stratification. Based on NCCN recommendation, patients with low-risk or
favorable intermediate-risk disease should be considered for evaluation with one or more tumor-based
molecular assays including Oncotype DX. This patients biopsy of the prostate demonstrated Gleason
3+3=6 prostate cancer with a PSA of 7.74 ng/mL. This is clinically staged as cT1c with NCCN low risk.
Based on current NCCN guidelines, Oncotype DX genomic prostate score testing is recommended to
determine subsequent treatment options including surveillance in patients with clinical NCCN low-risk
prostate adenocarcinoma. All told, the gene test (CPT 0047U) provided on 3/10/22 was likely to have
been more beneficial for the evaluation of the patients medical condition than any available standard
therapy.
| 1 |
A 31-year-old male enrollee has requested authorization and coverage for anastrozole 1 mg. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees medical condition.
This patient is being treated for testicular hypodysfunction with testosterone and human chorionic gonadotropin.
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Upheld
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Medical Necessity
|
Summary Reviewer
A 31-year-old male enrollee has requested authorization and coverage for anastrozole 1 mg. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees medical condition. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the requested medication. This patient is being treated for testicular hypodysfunction with testosterone and human chorionic gonadotropin. The laboratory studies from November 2015 and February 2016 show normal or high values of testosterone. For men who are hypogonadal, as evidenced by clinical symptoms and signs consistent with androgen deficiency and a subnormal morning serum testosterone concentration on three separate occasions, testosterone replacement therapy is recommended. The approved uses for anastrozole 1 mg include first-line treatment of locally-advanced or metastatic breast cancer (hormone receptor-positive or unknown) in postmenopausal women, adjuvant treatment of early hormone receptor-positive breast cancer in postmenopausal women or treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. In this case, the patient does not have an approved indication for the use of anastrozole. Furthermore, this medication is not recommended for the use of testicular hypofunction. The documentation supports that the patient has had improved symptoms while taking testosterone and human chorionic gonadotropin. Thus, the requested anastrozole 1 mg is not medically indicated 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 37-year-old male enrollee has requested authorization and coverage for the LINX procedure. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD).
In a group of 85 patients, augmentation of the lower esophageal sphincter (LES) with a magnetic device
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Upheld
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Experimental
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Summary Reviewer 3
A 37-year-old male enrollee has requested authorization and coverage for the LINX procedure. 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 the U.S. Food and Drug Administration (FDA) has 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. A recent study comparing the LINX procedure with laparoscopic fundoplication found that GERD patients had similar control of reflux symptoms after both LINX and fundoplication (Reynolds, et al). The inabilities to belch and vomit were significantly fewer with LINX, along with a significantly lower incidence of severe gas-bloat symptoms. In a group of 85 patients, augmentation of the lower esophageal sphincter (LES) with a magnetic device provided significant and sustained control of reflux, with minimal side effects or complications. No new safety risks emerged over a five-year follow-up period (Ganz, et al). This patient meets the specific criteria for LINX placement with a hiatal hernia that is only 0.2 cm larger than recommended for the procedure. All told, the requested LINX procedure 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 |
The patient is a 40-year-old male with a history of cocaine abuse. The patient reported that his cocaine abuse started about nine years ago, and increased from intermittently to daily. He was previously treated in March 2016. The patient relapsed one day after discharge and spent the next 4.5 months using 1 gram of cocaine a day. He was then admitted to psychiatric residential treatment center (RTC) on 7/17/16 with the diagnoses of cocaine use disorder, severe and major depressive disorder, severe. He related a history of depression and noted that prior treatment with Lexapro many years ago was helpful. He denied any other psychiatric symptomatology, past or present. He denied any medical problems. He said he used alcohol occasionally and it did not represent a problem, and denied use of any other substance. He reported sleep disturbance. There was no prior history of blackouts or seizures. He denied suicidal or homicidal ideation. The patient participated actively in his treatment plan, involving multiple modalities including relapse prevention, individual therapy, and group therapy. He continuously struggled with issues of self-worth, shame, and feelings of loneliness. He was treated with Seroquel 50 mg and no other medications. His vital signs were stable, and cravings were reported as infrequent to none. The patient has requested reimbursement for psychiatric RTC services provided from 7/23/16 through 8/30/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary.
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Upheld
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Medical Necessity
|
Summary Reviewer
The patient is a 40-year-old male with a history of cocaine abuse. The patient reported that his cocaine abuse started about nine years ago, and increased from intermittently to daily. He was previously treated in March 2016. The patient relapsed one day after discharge and spent the next 4.5 months using 1 gram of cocaine a day. He was then admitted to psychiatric residential treatment center (RTC) on 7/17/16 with the diagnoses of cocaine use disorder, severe and major depressive disorder, severe. He related a history of depression and noted that prior treatment with Lexapro many years ago was helpful. He denied any other psychiatric symptomatology, past or present. He denied any medical problems. He said he used alcohol occasionally and it did not represent a problem, and denied use of any other substance. He reported sleep disturbance. There was no prior history of blackouts or seizures. He denied suicidal or homicidal ideation. The patient participated actively in his treatment plan, involving multiple modalities including relapse prevention, individual therapy, and group therapy. He continuously struggled with issues of self-worth, shame, and feelings of loneliness. He was treated with Seroquel 50 mg and no other medications. His vital signs were stable, and cravings were reported as infrequent to none. The patient has requested reimbursement for psychiatric RTC services provided from 7/23/16 through 8/30/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary. Post-acute withdrawal symptoms in cocaine use disorders are not to be expected, nor were anything akin to these reported. He was not a danger to himself or others, and he was not violent or aggressive. There were no emotional, behavioral, or cognitive issues that warranted residential treatment. There was no evidence of mania or psychosis, or any other symptom complex which would have interfered with his recovery at a lower level of care. He was medically and psychiatrically stable. He was treated with Seroquel 50 mg and this was not adjusted. He was cooperative and engaged in his treatment. The issues addressed in his individual therapy did not require RTC level of care. The patient could have safely and effectively stepped down to a lower level of care as of 7/23/16. Thus, psychiatric RTC services provided from 7/23/16 through 8/30/16 were not medically necessary for treatment of the patients medical condition. Based on the foregoing discussion, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 21-year-old male enrollee has requested reimbursement for polymerase chain reaction testing performed on 6/07/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
patient continued to have signs and symptoms of chronic prostatitis, including persistent pyuria,
In this case, the patient had several trails of antibiotics and negative cultures for
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Upheld
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Experimental
|
Summary Reviewer 3
A 21-year-old male enrollee has requested reimbursement for polymerase chain reaction testing performed on 6/07/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that this patient continued to have signs and symptoms of chronic prostatitis, including persistent pyuria, most commonly indicating infection. Standard diagnostic testing, including culture for chlamydia and gonorrhea, as well as bacterial pathogens, did not reveal the cause of the persistent prostatitis. Standard antibiotic regimens were tried and were not successful. At that point, the specimen was sent for next generation sequencing. Although next generation sequencing has not yet made it into most guidelines for diagnosis and treatment of urinary tract infections, it plays an increasing role in cases where traditional culture and standard treatment trials have failed in an individual patient. In this case, the patient had several trails of antibiotics and negative cultures for chlamydia and gonorrhea by traditional culture methods. Therefore, next generation sequencing was a reasonable next step in the diagnosis of persistent symptoms and pyuria. Thus, polymerase chain reaction testing performed on 6/07/19 was likely to have been more beneficial than other methods of evaluating this patient.
| 1 |
The patient is a 15-year-old male with a past psychiatric history of attention
deficit/hyperactivity disorder, other specified depressive disorder, and specific learning
disorder with impairment in mathematics. The patients parent has requested reimbursement
for residential treatment level of care provided from 5/28/21 through 12/31/21.
tion, self-harm behaviors, and running away. He had a
history of homicidal ideation towards his mother and sister and had been physically aggressive
towards them. He is impulsive. For
assesses the degree to which a patient is able to fulfill responsibilities
within developmental constraints. The patients functioning has improved since being placed in
residential
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Overturned
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Medical Necessity
|
Summary Reviewer
The patient is a 15-year-old male with a past psychiatric history of attention
deficit/hyperactivity disorder, other specified depressive disorder, and specific learning
disorder with impairment in mathematics. The patients parent has requested reimbursement
for residential treatment level of care provided from 5/28/21 through 12/31/21. The physician
reviewer found that the American Academy of Child and Adolescent Psychiatry (AACAP) and
American Association for Community Psychiatry (AACP) have unified the Child and Adolescent
Level of Care Utilization System (CALOCUS) and the Child and Adolescent Service Intensity
Instrument (CASII) into a single instrument, the Child and Adolescent Level of Care/Service
Intensity Utilization System (CALOCUS-CASII). This instrument is a standardized tool used to
determine the intensity of services needed for children and adolescents, 6-18 years of age,
presenting with psychiatric, substance use, medical and/or developmental concerns. Using
CALOCUS-CASII, providers score patients on a scale of 1-5 using a six-pronged Dimensional
Rating System. The six dimensions include: (1) risk of harm; (2) functional status; (3) co-
occurrence of developmental, medical, substance use and psychiatric conditions; (4) recovery
environment (a. stressors and b. supports); (5) resiliency and response to services; and (6)
engagement. The composite score is then used to determine the level of care needed. Applying
the CALOCUS-CASII framework, the patient met the criteria for RTC services provided from
5/28/21 through 12/31/21. For dimension 1, risk of harm, the records support a score of 4. This
dimension assesses potential for harm to self or others, or having harm inflicted upon them.
The patient has a history of suicidal ideation, self-harm behaviors, and running away. He had a
history of homicidal ideation towards his mother and sister and had been physically aggressive
towards them. He is impulsive. For dimension 2, functional status, the records support a score
of 3. This dimension assesses the degree to which a patient is able to fulfill responsibilities
within developmental constraints. The patients functioning has improved since being placed in
residential treatment. However, he continues to struggle with anger dyscontrol, physical
aggression, and self-harm. Recent gains in functioning have been achieved only while
participating in residential treatment. For dimension 3, co-occurring developmental, medical,
substance use and psychiatric conditions, the records support a score of 3. This dimension
assesses the co-existence of disorders across four domains (psychiatric, substance use, medical
or developmental) that may complicate the course of treatment. This patient has significant co-
occurrence as evidenced by two neurodevelopmental disabilities (attention
deficit/hyperactivity disorder and learning disorder), depression, and insomnia. Attention
deficit/hyperactivity disorder is often associated with insomnia and lack of sleep can exacerbate
attention deficit/hyperactivity disorder symptoms, leading to increased acting out behaviors.
For dimension 4A, level of stress in the recovery environment, the records support a score of 4.
This dimension assesses the stressors in the environment, social circumstances, and
interpersonal relationships. His adoptive parents have expressed not wanting him to return
home. He has a difficult relationship with his adoptive mother. For dimension 4B, level of
support of the recovery environment, the records support a score of 3. This dimension assesses the presence of family and social support to augment the recovery environment. His adoptive
parents have not wanted the patient to return home. For dimension 5, resiliency and response
to services, the records support a score of 3. This dimension assesses how past experiences
with treatment and recovery might indicate how the patient might respond in the future. Prior
treatment included residential and psychiatric inpatient treatment. The patient has exhibited
moderate or equivocal response to current residential treatment placement. For dimension 6,
engagement of the patient, the records support a score of 3. The child and adolescent sub-
dimension assesses the patients ability to form therapeutic relationship within developmental
constraints. The patient continued to engage in self-harm behaviors during his treatment stay.
He struggled to engage in trauma therapy. These findings give the patient a composite score of
23, which is consistent with Level 5 Medically Monitored Residence Based Services. Per
CALOCUS-CASII, the childs scores of 4 for risk of harm also supports treatment at with Level 5
Medically Monitored Residence Based Services level of care. For these reasons, residential
treatment level of care provided from 5/28/21 through 12/31/21 was medically necessary for
the treatment of this patient.
| 1 |
A 60-year-old female enrollee has requested reimbursement for methylenetetrahydrofolate reductase (MTHFR) and nerve conduction velocity (NCV) studies provided on 9/22/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Hashimotos thyroiditis.
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Overturned
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Experimental
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Summary Reviewer 2
A 60-year-old female enrollee has requested reimbursement for methylenetetrahydrofolate reductase (MTHFR) and nerve conduction velocity (NCV) studies provided on 9/22/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Hashimotos thyroiditis. The physician reviewer found that Crone and Krarup noted diagnostic considerations for use of NCV are based on a flow chart classifying neuropathies into eight categories based on mode of onset, distribution, and electrophysiological findings, and the electrophysiological characteristics in each type of neuropathy are discussed. NCV is useful for evaluation of neurologic deficits but is not recommended in the absence of neurologic symptoms or physical findings. The medical records do not indicate physical exam findings of focal neurologic deficit or symptoms in support of NCV testing. In addition, NCV testing is not supported for evaluation of Hashimotos thyroiditis. As there are no neurologic symptoms or findings reported, NCV studies were not appropriate for evaluation of this patients medical condition. There is one publication in regard to MTHFR use for association with Hashimotos disease, but there is a lack of support for clinical application for individual clinical determination. Arakawa and colleagues found that some data suggests that a certain genotype correlates with DNA hypomethylation and with the intractability of goiter, and another genotype may correlate with the severity of Hashimotos disease. However, the authors noted that additional studies are needed to determine clinical correlation. Consistent with these findings, the MTHFR and NCV studies provided on 9/22/15 were 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 60-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
|
Summary Reviewer 3
A 60-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 is a lack of evidence in the medical literature to suggest that proton therapy for prostate cancer is associated with improved outcomes compared to standard treatment with intensity modulated radiation with image guidance. A recent comparative effectiveness study found no significant difference in toxicities between proton therapy and standard treatment (Sheets, et al). In addition, the National Comprehensive Cancer Network (NCCN) guidelines state that proton therapy for prostate cancer should not be performed outside of a clinical trial. Further, the American Society of Radiation Oncology (ASTRO) has also issued a position statement emphasizing that proton therapy should not be delivered for prostate cancer (Hahn, et al). Therefore, the requested proton beam radiation therapy is not likely to be more beneficial for the patients prostate cancer than standard therapy. Based upon the information set forth above, I have determined the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 62-year-old female enrollee has requested authorization and coverage for Repatha SureClick 140 mg/mL. 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.
that the patient has a cardiomyopathy and a diagnosis of angina, although there is no
for coronary artery disease. However, she does have severe hyperlipidemia and a strong family history of early coronary artery disease. In addition, she has been intolerant of multiple statin medications due to recurrent myalgias and also a trial of ezetimibe and bile acid resins
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Overturned
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Medical Necessity
|
Summary Reviewer
A 62-year-old female enrollee has requested authorization and coverage for Repatha SureClick 140 mg/mL. 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 the patient has a cardiomyopathy and a diagnosis of angina, although there is no documentation of testing for coronary artery disease. However, she does have severe hyperlipidemia and a strong family history of early coronary artery disease. In addition, she has been intolerant of multiple statin medications due to recurrent myalgias and also a trial of ezetimibe and bile acid resins which did not get her to LDL goal. Although the extent of established coronary artery disease is not clear, she does carry a diagnosis of angina and is prescribed nitroglycerin for this. In addition, she has severe baseline hyperlipidemia and a trial of statins and multiple other lipid lowering medications has been ineffective or not tolerated due to significant side effects necessitating discontinuation of these medications. There is little chance that lifestyle and dietary modifications would decrease her LDL to less than 100 (goal) without pharmacologic therapy. Since she is multi-statin intolerant and bile acid resins and ezetimibe have been ineffective, her only option is a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor. Thus, Repatha is indicated for the treatment of this patient. Therefore, Repatha SureClick 140 mg/mL is medically necessary for the treatment of this patient.
| 1 |
A 46-year-old male enrollee has requested authorization and coverage for Acthar Gel. The Health
Insurer has denied this request indicating that the requested medication is investigational for the
treatment of the enrollees sarcoidosis.
|
Upheld
|
Experimental
|
Summary Reviewer 3
A 46-year-old male enrollee has requested authorization and coverage for Acthar Gel. The Health
Insurer has denied this request indicating that the requested medication is investigational for the
treatment of the enrollees sarcoidosis. The physician reviewer found that while there is a lack of
organizational guidelines on the treatment of sarcoidosis, based on case reports and small
studies, sarcoidosis refractory to prednisone is frequently treated with disease modifying anti-
rheumatic drugs (DMARDs) such as methotrexate, Plaquenil, leflunomide, and infliximab. The
FDA approves the use of Acthar Gel for the treatment of sarcoidosis. Baughman, and colleagues
note an improvement in symptoms of fatigue, pulmonary function testing, chest imaging, and
quality of life, along with decreasing prednisone doses with the use of repository corticotropin.
Chopra and colleagues report that the use of repository corticotropin resulted in improvement
in patients with advanced symptomatic sarcoidosis. In this clinical setting, given the side effects
that may accompany standard therapies, the requested medication is likely to be more beneficial
for the treatment of this patients sarcoidosis than available standard therapy. Therefore, Acthar
Gel is likely to be more beneficial for treatment of the patients condition than any available
standard therapy.
| 1 |
A 61-year-old female enrollee has requested reimbursement for the office visits provided on 5/20/16, 8/25/16, and 11/17/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees hypothyroidism, Hashimotos thyroiditis, menopause syndrome, and iron deficiency anemia.
|
Overturned
|
Experimental
|
Summary Reviewer 2
A 61-year-old female enrollee has requested reimbursement for the office visits provided on 5/20/16, 8/25/16, and 11/17/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees hypothyroidism, Hashimotos thyroiditis, menopause syndrome, and iron deficiency anemia. The physician reviewer found that Hypothyroidism, also called underactive thyroid or low thyroid, is a common disorder of the endocrine system in which the thyroid gland does not produce enough thyroid hormone. If not properly treated, hypothyroidism can cause a number of symptoms such as poor ability to tolerate cold, a feeling of fatigue, constipation, depression, and weight gain. LT4 monotherapy has emerged as the therapy of choice for treatment of hypothyroidism (Hennessey). However, due to the narrow therapeutic window of LT4, it is important to closely monitor dose selection and achievement of thyrotropin goals that are specific to the individual patients overall clinical situation (Jonklaas). Providers should follow patients closely in order to properly adjust their dosages of thyroid hormone therapy. For these reasons, the office visits provided on 5/20/16, 8/25/16, and 11/17/16 were 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 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 parent of an 11-year-old female enrollee has requested authorization and coverage for Nutropin. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees short stature.
|
Upheld
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Medical Necessity
|
Summary Reviewer
The parent of an 11-year-old female enrollee has requested authorization and coverage for Nutropin. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees short stature. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the requested medication. There is insufficient information provided to determine the medical necessity of continuation of growth hormone therapy. As the case material includes a growth chart with only one data point, it is not possible to determine if this patient experienced poor growth velocity prior to growth hormone treatment. In addition, no data are provided about pre-treatment IGF-1 or insulin-like growth factor binding protein 3 (IGFBP-3) levels, or pre-treatment laboratory work-up to rule out other causes of growth fall-off. All told, Nutropin is not medically indicated 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 |
patient is a 63-year-old female who has undergone very extensive cervical spine surgery dating back
to 1999. Her first surgery was a C6-7 anterior cervical discectomy and fusion (ACDF).
|
Upheld
|
Medical Necessity
|
Summary Reviewer
The patient is a 63-year-old female who has undergone very extensive cervical spine surgery dating back
to 1999. Her first surgery was a C6-7 anterior cervical discectomy and fusion (ACDF). The physician
reviewer found that the cervical arthroplasty was developed as a motion-preserving device to maintain
the cervical joint complex biomechanics and attempt to limit the development of adjacent segment
disease that can occur when treating cervical pathology with an arthrodesis. Although there are
substantial data supporting the benefits of arthroplasty, it remains controversial as to whether it is
superior to ACDF. In a recent five-year outcome study of a prospective randomized trial, Johansen and
colleagues reported similar outcomes between arthroplasty and ACDF over a number of measures in the
treatment of C6 or C7 radiculopathy.
The indications for a cervical arthroplasty are for cervical disease from C3-4 down to C6-7. A recent
meta-analysis by Wang and colleagues explored the efficacy of arthroplasty versus ACDF. Only patients
with disease from C3-4 to C6-7 were included in the included studies. Although these authors concluded
that compared to ACDF, arthroplasties resulted in better outcomes over a number of domains, including
rates of adjacent segment disease, there was no meaningful evaluation of its utility at C7-T1. In general,
C7-T1 would be a very challenging level at which to perform an arthroplasty given how low it is in the
cervical spine and the difficulties in visualizing it properly with intraoperative techniques. Excellent
visualization for perfect implant placement is critical for the best possible outcomes.
Although there are data to suggest that one of the main ways arthroplasty is superior to ACDF is in
reducing adjacent segment disease, its value in achieving this, especially at C7-T1, is not clear. This is
particularly noteworthy in the current patient. This patient has already undergone a C6-7 arthrodesis,
and T1-2 is a generally immobile level due to the presence of the ribs fixating the thoracic spine. Kelly
and colleagues evaluated data for over 50,000 patients who underwent ACDF or arthroplasty.
Subsequent cervical surgery rates were not significantly different between the groups at one, three and
five years postoperatively.
There are several widely held contraindications for arthroplasty, and this patient appears to harbor
them. Facet disease is an important contraindication for arthroplasty. The patients imaging studies
indicate that at C7-T1 there is remarkable facet disease. The patient underwent facet injections that
improved her pain reportedly. Arthroplasty is contraindicated with facet disease, and is not thought to
address it. Spinal deformity is another contraindication for arthroplasty. The patient has numerous
imaging studies that indicate anterolisthesis at C7-T1. Indeed, this was measured up to 4 mm on x-rays.
Finally, osteoporosis or poor bone quality is another relative contraindication. Several of this patients
imaging studies document osteopenia.
The patients provider indicates in his November 2021 note that operating from an anterior approach in
the spine would be risky with regard to an arthrodesis. This would be no different for an arthroplasty,
and arthroplasty would offer no benefits in this regard. The provider notes that treatment of C7-T1
would require a combination anterior/posterior approach. This is debatable. Finally, over the course of
the past year, the patient has undergone several surgical procedures on her neck. Her last one was
performed six weeks prior to the recommendation for the currently pursued surgery. It is arguable that
the patient has not completely recovered from her other surgeries to allow for making a determination
on another. Finally, the documented symptoms the patient reports are quite vague (neck pain, hand
pain, right jaw symptoms, scapula pain, chest tightness and shortness of breath, and coldness in the
fingertips). It is not likely that an arthroplasty at C7-T1 would address these. Based on the submitted
documentation, the requested total disc arthroplasty C7-T1 anterior approach discectomy end plate
preparation is not medically necessary for the treatment of this patient.
| 1 |
A 76-year-old male enrollee has requested reimbursement for the Oncotype DX Colon Cancer Assay (CPT 81525) performed on 10/25/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees stage II colon cancer.
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Upheld
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Experimental
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Summary Reviewer 2
A 76-year-old male enrollee has requested reimbursement for the Oncotype DX Colon Cancer Assay (CPT 81525) performed on 10/25/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees stage II colon cancer. The physician reviewer found that the peer-reviewed medical literature has not established the utility of molecular markers in treatment determination and prognosis in patients with colon cancer. The Oncotype DX Colon Cancer Assay does not have specific U.S. Food and Drug Administration (FDA) approval for use in stage II colon cancer. Further, the assay has not been proven to predict which patients with stage II disease could benefit from adjuvant therapy. Moreover, the American Society of Clinical Oncology (ASCO) guidelines do not address use of this assay. Accordingly, the Oncotype DX Colon Cancer Assay (CPT 81525) performed on 10/25/17 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 30-year-old male enrollee has requested authorization and coverage for suction assisted lipectomy, trunk (CPT 15877) and mastectomy, simple complete (CPT 19303). The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition.
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Upheld
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Medical Necessity
|
Summary Reviewer
A 30-year-old male enrollee has requested authorization and coverage for suction assisted lipectomy, trunk (CPT 15877) and mastectomy, simple complete (CPT 19303). The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that Arya and colleagues stated, True gynecomastia refers to enlarged glandular tissue rather than deposition of fat tissue. Enlargement of breast due to deposition of fat in the breast area is known as pseudogynecomastia. Bellini and colleagues stated, In pseudogynecomastia, there is an increased development of the fatty component in the male breast region. In true gynecomastia, however, there is an increase in volume of the male breast gland with a dense fibrous and vascular stroma, which makes suction more difficult. The gynecomastia liposuction treatment is usually associated to a resection under direct vision of the glandular tissue through a periareolar or transareolar incision. Innocenti and colleagues stated, in regard to excision of gynecomastia, that If necessary, liposuction of the peripheral fatty tissue was usually performed. Liposuction for chest contouring of fatty tissue can be performed in addition to direct excision of glandular gynecomastia for an improved cosmetic result on the entire chest. Liposuction around the glandular tissue is not a separate technique but is rather a more efficient method of fat excision. Fatty tissue removal around the glandular tissue for contouring is an included part of excision of gynecomastia. It is not a separate procedure. Extensive liposuction to the anterior chest for removal of pseudogynecomastia and general chest contouring is not medically necessary and is a cosmetic procedure. Suction assisted lipectomy trunk (CPT 15877) is not medically necessary as a separately billed procedure. In this case, the Health Insurer declined coverage for 19303 because the code is for a mastectomy in a woman. However, the Health Insurer did approve 19300 on appeal because that applied to a mastectomy for gynecomastia in a male. CPT 19303 is not medically necessary because it applies to a mastectomy in a woman. Therefore, suction assisted lipectomy, trunk (CPT 15877) and mastectomy, simple complete (CPT 19303) are not medically necessary for the treatment of this patient.
| 1 |
An 83-year-old male enrollee has requested reimbursement for Guardant360 CDx testing
performed on 3/31/21. The Health Insurer has denied this request and reported that the services
at issue were investigational for the evaluation of the enrollees medical condition.
In this case, it was
important to know whether the patient had developed an EGFR T790M mutation.
|
Overturned
|
Experimental
|
Summary Reviewer 3
An 83-year-old male enrollee has requested reimbursement for Guardant360 CDx testing
performed on 3/31/21. 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 the therapy of advanced NSCLC has been revolutionized by the finding of EGFR
mutations in certain adenocarcinomas. The mutations are more common in those who have
never smoked. Even if stage IV disease is present, therapy targeted to EGFR with erlotinib results
in prolonged survival when compared with standard chemotherapy regimens. In this case, it was
important to know whether the patient had developed an EGFR T790M mutation. This mutation
confers resistance to erlotinib and has been observed in 60% of patients with progressive disease
on erlotinib. There is a new tyrosine kinase inhibitor available that can target this mutation,
osimertinib, which could have been used if this mutation was observed. In order to analyze for
this mutation, a liquid biopsy was ordered. The Guardant360 test is commonly referred to as a
liquid biopsy since it involves sampling of tumor cells that may be circulating in the peripheral
blood. Up to 70 genes can be analyzed for mutations. The test is known for high specificity but
low sensitivity. According to the NCCN guidelines, it is associated with false negative rates of up
to 30%. The guidelines note that the test is acceptable if the patient is unfit to pursue more
invasive methods for tumor sampling. If a simple core biopsy of an accessible metastatic lymph
node, like a supraclavicular or axillary lymph node, was feasible, then a Guardant360 testing
would have been unreasonable; but that is not the case here. Per the submitted records, the
tumor sample was noted as being inadequate for subsequent analysis. There was sufficient
support for Guardant360 testing in this setting since disease was inaccessible. Therefore,
Guardant360 CDx testing performed on 3/31/21 was likely to have been more beneficial for
evaluation of the patients medical condition than any available standard therapy.
| 1 |
The patient is a 57-year-old female with severe osteoporosis. As part of the work-up her endocrinologist ordered a parathyroid scan to rule out a parathyroid adenoma. The patient has requested authorization and coverage for parathyroid planar imaging. The Health Insurer has denied this request indicating that the requested diagnostic procedure is not medically necessary. The records provided for review indicate that this patient has severe osteoporosis and further evaluation for a parathyroid adenoma (primary hyperparathyroidism) is
tests performed on 10/26/17 show normal calcium, mid-normal intact PTH level at 36 and normal ioni
|
Upheld
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Medical Necessity
|
Summary Reviewer
The patient is a 57-year-old female with severe osteoporosis. As part of the work-up her endocrinologist ordered a parathyroid scan to rule out a parathyroid adenoma. The patient has requested authorization and coverage for parathyroid planar imaging. The Health Insurer has denied this request indicating that the requested diagnostic procedure is not medically necessary. The records provided for review indicate that this patient has severe osteoporosis and further evaluation for a parathyroid adenoma (primary hyperparathyroidism) is appropriate. However, the medical literature suggests that the diagnosis should be made with biochemical markers showing the combination of hypercalcemia and an elevated or inappropriately normal parathyroid hormone (PTH) level. Measured total serum calcium should be adjusted for albumin. If the corrected serum calcium is normal and PTH is elevated, serum ionized calcium should be measured, as primary hyperparathyroidism can present with an elevated ionized calcium despite a normal albumin-adjusted serum calcium (Khan, et al). The standards of care also indicate that parathyroid scan is appropriate when a decision to remove a parathyroid adenoma has been made (Khan, et al; Bilezikian, et al; Pallan, et al). Overall, parathyroid imaging is not a diagnostic procedure and is not advised unless surgical intervention is planned. The value of imaging rests with accurate identification of abnormal parathyroid tissue in order to assist in planning the appropriate parathyroid surgery (Khan, et al). In this case the diagnosis of primary hyperparathyroidism has not been established. The laboratory tests performed on 10/26/17 show normal calcium, mid-normal intact PTH level at 36 and normal ionized calcium and phosphorus. The patients 25 vitamin D and 1, 5 vitamin D levels are normal, and urinary calcium is normal. In January 2018, the patient had two normal calcium levels and intact PTH. As the patient does not have biochemical evidence of primary hyperparathyroidism, the requested parathyroid planar imaging is not medically necessary for evaluation of this patients medical condition. Based on the foregoing discussion, the requested diagnostic procedure is not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
The parent of a 14-year-old female enrollee has requested reimbursement and prospective authorization and coverage for residential treatment from 5/21/14 forward. The Health Plan has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health conditions.]
During the family session on 10/27/14, the unit addressed reality and expectation in a healthy manner. Prior to that appointment, the patient successfully completed a three-day adventure therapy trip. On 10/31/14, during the individual therapy session, the patient was able to show empathy and acceptance for an unexpected interruption.
|
Overturned
|
Medical Necessity
|
Summary Reviewer
The parent of a 14-year-old female enrollee has requested reimbursement and prospective authorization and coverage for residential treatment from 5/21/14 forward. The Health Plan has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health conditions.] The physician reviewer found the submitted documentation supports the medical necessity of a portion of the services at issue. Considering that the patient had failed treatment in a less restrictive setting and was engaging in increasingly concerning activity, placement at the residential level of care was initially indicated as the services were reasonably expected to improve her condition at the time, and prevent a more serious episode of illness. However, the record does not justify the medical necessity of ongoing treatment at the residential level of care from 11/01/14 forward. The diagnosis of mood disorder, not otherwise specified has not been refined or updated. There has been no change to the medication regimen which infers an element of clinical stability. During the family session on 10/27/14, the unit addressed reality and expectation in a healthy manner. Prior to that appointment, the patient successfully completed a three-day adventure therapy trip. On 10/31/14, during the individual therapy session, the patient was able to show empathy and acceptance for an unexpected interruption. Considering the positive clinical trend in the medical records coupled with community practice standards and current practice guidelines, residential treatment services from 5/21/14 through 10/31/14 were medically necessary for treatment of the patients medical condition. However, services from 11/1/14 onward were not and are not medically necessary based on the documentation provided. Therefore, a portion of the services at issue was medically necessary for treatment of the patients medical condition. The Health Insurers denial should be partially overturned.
| 1 |
A 46-year-old female enrollee has requested reimbursement for substance use residential treatment provided from 6/07/18 through 6/24/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition.
a lack of current suicidal ideation with active intent or plan. The records noted that the patient had passive suicidal ideation.
|
Upheld
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Medical Necessity
|
Summary Reviewer
A 46-year-old female enrollee has requested reimbursement for substance use residential treatment provided from 6/07/18 through 6/24/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that in cases such as this, an evidence-based, objective, instrument such as the American Association of Community Psychiatrists Level of Care Utilization System (LOCUS) is indispensable in determining necessary and appropriate level of care for adults. In terms of risk of harm, the records support a score of 2 due to a lack of current suicidal ideation with active intent or plan. The records noted that the patient had passive suicidal ideation. With regards to functional status, the records support a score of 3 due to overall fair functional level in treatment but consideration of functional problems when in the community and using substances. In terms of medical, addictive and psychiatric comorbidity, the records support a score of 2 due to overall medical stability and history of mood symptoms. With regards to level of stress of the recovery environment, the records support a score of 2 due to a stable living environment with roommates. In terms of level of support of the recovery environment, the records support a score of 2 due to overall supportive recovery environment. With regards to treatment and recovery history, the records support a score of 3 due to current motivation for treatment but unclear response to treatment in the past. In terms of engagement and recovery status, the records support a score of 2 due to cooperation in treatment. Thus, the patient has a composite score of 16. This correlates with low-intensity community-based services. Therefore, residential treatment was not medically indicated. In sum, substance use residential treatment provided from 6/07/18 through 6/25/18 was not medically necessary for the treatment of this patient.
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