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A 62-year-old female has requested reimbursement gene testing performed on 11/01/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 1
A 62-year-old female has requested reimbursement gene testing performed on 11/01/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found molecular profiling is an assay to detect genomic or molecular abnormalities or gene overexpressions in an individuals cancer cells, with the hope that this information will guide therapy. However, there is a lack of convincing evidence that such assays add to our decision-making ability. There are a variety of non-randomized studies exploring the value of molecular profiling that have as yet not yielded evidence of significant benefit to such assays. Therefore, the superior efficacy of gene testing performed on 11/01/15 has not been established. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The patient is a 44-year-old female with a history of dense breasts on mammography and calculated lifetime risk of breast cancer at 20.8%. She had magnetic resonance imaging (MRI) of the breasts on 9/22/17 which revealed a single lymph node requiring second look, ultrasound but no evidence of malignancy. For the MRI, computer aided detection (CAD) was also performed. The patient has requested reimbursement for the computer aided detection provided on 9/22/17. The Health Insurer has denied this request indicating that the diagnostic procedure at issue was not medically necessary. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 44-year-old female with a history of dense breasts on mammography and calculated lifetime risk of breast cancer at 20.8%. She had magnetic resonance imaging (MRI) of the breasts on 9/22/17 which revealed a single lymph node requiring second look, ultrasound but no evidence of malignancy. For the MRI, computer aided detection (CAD) was also performed. The patient has requested reimbursement for the computer aided detection provided on 9/22/17. The Health Insurer has denied this request indicating that the diagnostic procedure at issue was not medically necessary. The MRI of the breasts performed on 9/22/17 was indicated in light of the limitations inherent in routine mammography especially in patients with dense breasts and the calculated lifetime risk of breast cancer exceeding 20%. However, there is a lack of data demonstrating improve health outcomes with use of CAD with breast MRI. Overall, the studies suggest the use of CAD can improve the speed and throughput of the imaging, but does not support its utility in terms of superior detection of breast cancer. Thus, the CAD provided on 9/22/17 was not medically necessary for evaluation of this patients medical condition. Based on the foregoing discussion, the diagnostic procedure at issue was not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
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patient is a four-year-old female with a history of lamellar ichthyosis. The records provided
for review indicate that the patient was previously treated with tazarotene cream with great efficacy
and improvement in her skin condition. The provider has recommended treatment with tazarotene
cream. The Health Insurer has denied the requested treatment as not medically necessary for the
treatment of the patients medical condition.
In this case, the patient has a history of lamellar
ichthyosis which has been successfully treated with tazarotene | Overturned | Medical Necessity | Summary
The patient is a four-year-old female with a history of lamellar ichthyosis. The records provided
for review indicate that the patient was previously treated with tazarotene cream with great efficacy
and improvement in her skin condition. The provider has recommended treatment with tazarotene
cream. The Health Insurer has denied the requested treatment as not medically necessary for the
treatment of the patients medical condition. This denial is the subject of this appeal and
determination. The physician reviewer found that currently, there is a lack of U.S. Food and Drug
Administration (FDA) approved treatments for patients with lamellar ichthyosis. According to the
Pediatric Dermatology Research Alliance (PeDRA) guidelines, topical retinoids are preferred over
systemic retinoids for the treatment of pediatric patients with lamellar ichthyosis, as topical
retinoids have been demonstrated to have a higher level of tolerability and a greater reduction of
side effects (Hanson, et al.; Zaenglein, et al.). In this case, the patient has a history of lamellar
ichthyosis which has been successfully treated with tazarotene cream. The records provided for
review indicate that the discontinuation of topical tazarotene resulted in worsening of the patients
scales and symptoms. Furthermore, the medical literature suggests that topical retinoids are the
preferred treatment option over systemic retinoids for pediatric patients with lamellar ichthyosis.
For these reasons, the requested tazarotene cream 0.1% is medically necessary for the treatment of
this patient.
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A 58-year-old female enrollee has requested reimbursement for the blood test (Guardant360 biopsy-free tumor sequencing test) performed on 12/8/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees stage lung adenocarcinoma. | Overturned | Experimental | Summary Reviewer 1
A 58-year-old female enrollee has requested reimbursement for the blood test (Guardant360 biopsy-free tumor sequencing test) performed on 12/8/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees stage lung adenocarcinoma. The physician reviewer found that molecular diagnostic studies in non-small cell lung cancer (NSCLC) are considered the current standard of care. Numerous gene alterations have been identified that impact therapy selection. The National Comprehensive Cancer Network (NCCN) guidelines advise broader molecular profiling with the goal of identifying rare driver mutations for which effective drugs may already be available, or to appropriately counsel patients regarding the availability of clinical trials. Broad molecular profiling is a key component of the improvement of care of patients with NSCLC. Testing of lung cancer specimens for these alterations is important for identification of potentially efficacious targeted therapies, as well as avoidance of therapies unlikely to provide clinical benefit. Thus, molecular profiling with the blood test (Guardant360 biopsy-free tumor sequencing test) performed on 12/8/17 was likely to be more beneficial than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 49-year-old male enrollee has requested reimbursement for a positron emission tomography (PET) scan performed on 6/30/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
that patient was found to have retroperitoneal lymphadenopathy, for which he underwent CT-guided bone marrow biopsy and then PET scan. | Overturned | Experimental | Summary Reviewer 3
A 49-year-old male enrollee has requested reimbursement for a positron emission tomography (PET) scan performed on 6/30/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that with the limited information that was provided, it seems that patient was found to have retroperitoneal lymphadenopathy, for which he underwent CT-guided bone marrow biopsy and then PET scan. Assuming that the cause of lymphadenopathy is unknown, CT-guided tissue sampling for bone marrow would be a standard approach. Also, to find out the extent of lymphadenopathy in the remaining body parts such as neck, chest, abdomen and pelvis, PET was also indicated. Thus, PET scan performed on 6/30/17 was likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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patient is a 24-year-old female with a medical history significant for congenital central hypoventilation syndrome and subsequent cardiac arrhythmia, requiring pacemaker placement. The patient has requested authorization and coverage for a home ventilator. The Health Insurer has denied this request and reported that the requested equipment is not medically necessary for the treatment of this patient. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 24-year-old female with a medical history significant for congenital central hypoventilation syndrome and subsequent cardiac arrhythmia, requiring pacemaker placement. The patient has requested authorization and coverage for a home ventilator. The Health Insurer has denied this request and reported that the requested equipment is not medically necessary for the treatment of this patient. The physician reviewer found that congenital central hypoventilation syndrome is an extremely rare disorder. These patients lack the expected arousal response to hypoxemia and hypercarbia during sleep, and in extreme cases, during wakefulness as well. They do not respond like typical patients to exercise or infection, either because they do not perceive hypoxemia or hypercarbia. They are at long-term risk for cardiac abnormalities and pulmonary hypertension. Management of these patients involves and requires ventilatory support with non-invasive or tracheostomy-associated mechanical ventilation. This is the standard of care and it is life-preserving and lifesaving in this very complicated yet small patient population. Therefore, the requested home ventilator is medically necessary for the treatment of this patient. | 1 |
patient is a 44-year-old male who was admitted to a residential treatment center (RTC) on
5/2/23 and presented for an evaluation. The patient has requested authorization and coverage
for residential treatment services from 5/25/23 and forward.
has a significant risk of harm, due to a history of excessive substance use resulting
in potentially harmful behavior including legal trouble and incarceration. The patient displays
periods of inability to self-care in his environment. The patient does not currently endorse
suicidal ideation.
serious functional impairment due to the patients inability to work
due to his symptoms. The patient is in the process of applying for short term disability while in
RTC due to an inability to work due to his symptoms. | Overturned | Medical Necessity | Summary
The patient is a 44-year-old male who was admitted to a residential treatment center (RTC) on
5/2/23 and presented for an evaluation. The patient has requested authorization and coverage
for residential treatment services from 5/25/23 and forward. The physician reviewer found that
at issue is whether residential treatment services from 5/25/23 and forward were and/or are
medically necessary for the treatment of this patient. The American Association of Community
Psychiatrists Level of Care Utilization System (LOCUS) provides a reliable framework for
determining the appropriate level of care for adults needing mental health treatment. Using
LOCUS, 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) medical, addictive and
psychiatric comorbidity; (4) recovery environment (a. stressors and b. supports); (5) treatment
and recovery history; and (6) engagement. The composite score is then used to determine the
level of care needed. For dimension 1, with regard to risk of harm, the records support a score of
3. The patient has a significant risk of harm, due to a history of excessive substance use resulting
in potentially harmful behavior including legal trouble and incarceration. The patient displays
periods of inability to self-care in his environment. The patient does not currently endorse
suicidal ideation. For dimension 2, in terms of functional status, the records support a score of 4.
The documentation notes serious functional impairment due to the patients inability to work
due to his symptoms. The patient is in the process of applying for short term disability while in
RTC due to an inability to work due to his symptoms. For dimension 3, with regard to comorbidity,
the records support a score of 3. The patient has significant comorbidity due to the presence of
substance abuse which, though temporarily arrested, has a significant adverse effect on his
functioning and presenting condition, and impedes his recovery. For dimension 4A, in terms of
the level of stress of the recovery environment, the records support a score of 4. The patient has
a highly stressful environment due to severe disruption in his life circumstances as a result of a
recent incarceration and separation from his wife and three children. The patient is isolated, with
a restraining order against him. For dimension 4B, with regard to the level of support of the
recovery environment, the records support a score of 4 as the patient has very limited social
support, with only support from brother, and is separated from his wife and children. For
dimension 5, in terms of resiliency and treatment history, the records support a score of 4. The
patient has poor resiliency and/or response to services as a psychiatric hospitalization led to the
patients admission to the RTC. Previous treatment for substance use has not resulted in
remission or optimal control of symptoms. For dimension 6, with regard to treatment acceptance
and engagement, the records support a score of 3. The patient has some variability in acceptance
of his illness and has trouble accepting responsibility for his recovery. Thus, the patient has a total
score of 25. The records support a 4 in terms of functional status. In this case, the recommended
level of care is medically monitored residence-based services. With the functional impairment
noted, the patient meets LOCUS 5b extended stay criteria. Therefore, residential treatment
services from 5/25/23 and forward were and are medically necessary for the treatment of this
patient. | 1 |
A 35-year-old female has requested reimbursement for Oncotype Dx Colon Cancer Assay provided on 11/16/18. The Health Insurer has denied this request indicating that the services at issue were investigational for the evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 1
A 35-year-old female has requested reimbursement for Oncotype Dx Colon Cancer Assay provided on 11/16/18. The Health Insurer has denied this request indicating that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that Adjuvant chemotherapy is of benefit to patients with stage III (node positive) colon cancer. It is much more controversial as to the usefulness of adjuvant chemotherapy in stage II colon cancer, as in this patients case. Most oncologists make this decision based on specific pathologic and clinical features in an individual that imply higher risk of recurrence. Among these features that can place a patient in a higher risk category are poorly differentiated histology, a pT4 lesion, lymphovascular invasion, or presentation with perforation/obstruction. In this case, the records do not document these features. Oncotype DX Colon Cancer Assay is a 12-gene panel that may predict the risk of recurrence in both stage III and II colon cancer. However, it is not clear if the assay can be used to predict the value of adjuvant chemotherapy in the absence of other high risk features. Therefore, Oncotype DX Colon Cancer Assay performed on 11/16/18 was not likely to have been of greater benefit than other methods of evaluating this patient.
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A 57-year-old female enrollee has requested reimbursement for testing for cancer risk using panels of genes (MyRisk) provided on 6/05/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 1
A 57-year-old female enrollee has requested reimbursement for testing for cancer risk using panels of genes (MyRisk) provided on 6/05/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the superior efficacy of a portion of the services at issue. Given that the patients mother developed breast cancer at age 36, she does fall within guidelines for BRCA testing. However, this patient was evaluated with the MyRisk panel, which is a 25 gene panel including BRCA. Although there is great interest in the other genes, there is little data to support making clinical decisions on the basis of the other genes alone. Even in families with a strong history, such as this one, it is not clear that the other genes significantly add to the risk profile beyond what the family history alone provides. Therefore, the BRCA portion of the testing was likely to have been more beneficial than other methods of evaluating this patient. However, the superior effectiveness of the remaining tests has not been established.
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A 39-year-old male enrollee has requested authorization and coverage for Stelara (ustekinumab). The Health Insurer has denied this request indicating that the requested medication is investigational for treatment of the enrollees medical condition.
, the patient presents with refractory Crohns disease manifest by severe ileitis. | Overturned | Experimental | Summary Reviewer 3
A 39-year-old male enrollee has requested authorization and coverage for Stelara (ustekinumab). The Health Insurer has denied this request indicating that the requested medication is investigational for treatment of the enrollees medical condition. The physician reviewer found that in this case, the patient presents with refractory Crohns disease manifest by severe ileitis. There is sufficient support in the peer-reviewed literature for Stelara to be utilized in this clinical setting. The study by Sandborn and colleagues found that patients with moderate to severe Crohns disease resistant to tumor necrosis factor (TNF) antagonists had an increased rate of response to induction with ustekinumab compared with placebo. In addition, the authors concluded that Patients with an initial response to ustekinumab had significantly increased rates of response and remission with ustekinumab as maintenance therapy. In light of lack of viable options to treat this patient with refractory, progressive Crohns disease and support in the peer-reviewed literature, Stelara medication is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested medication is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 26-year-old female enrollee has requested reimbursement for the L3-5 discectomy performed on 12/16/15. The Health Insurer has denied this request indicating that the surgery at issue was not medically necessary for treatment of the enrollees lumbar radiculopathy. | Upheld | Medical Necessity | Summary Reviewer
A 26-year-old female enrollee has requested reimbursement for the L3-5 discectomy performed on 12/16/15. The Health Insurer has denied this request indicating that the surgery at issue was not medically necessary for treatment of the enrollees lumbar radiculopathy. The physician reviewer found the medical records, physical examination findings, and MRI findings do not support the medical necessity of the surgery at issue. There is no correlation between physical examination and imaging. In addition, there is no severe nerve root compression on MRI and the patient has not reportedly exhausted conservative measures. Moreover, there were no red flags for surgery or significant neurological deficit. All told, the L3-5 discectomy performed on 12/16/15 was not medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the surgery at issue was not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
The parent of a 15-year-old male enrollee has requested reimbursement for the unlisted chemistry procedure, Anser IFX assay testing (CPT code 84999) performed on 11/17/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Crohns disease. | Overturned | Experimental | Summary Reviewer 3
The parent of a 15-year-old male enrollee has requested reimbursement for the unlisted chemistry procedure, Anser IFX assay testing (CPT code 84999) performed on 11/17/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Testing for the presence of antibodies to infliximab (ATI) is appropriate in the setting of an acute infusion reaction, even when not severe. These reactions are important immunological events which should prompt ATI and infliximab trough level determination (Lichtenstein, et al). The presence of ATI can help to determine likelihood of a future reaction. Patients who have ATI have more than a two-fold risk of a subsequent reaction, and nearly a six-fold risk of a severe reaction, compared to those who do not have ATI (OMeara, et al). In addition, allowing for assessment of future infusion reaction risk, the presence of ATIs may also help to guide therapeutic decision-making in regard to the potential addition of concomitant immunomodulatory therapy, which is known to decrease ATI level and decrease drug reaction risk (Ben-Horin, et al). Accordingly, the unlisted chemistry procedure, Anser IFX assay testing (CPT code 84999) performed on 11/17/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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The patient is a 63-year-old male with metastatic thymic cancer, stage IV with pleural dissemination. He was initially diagnosed in November 2014. On 4/29/15, he underwent an anterior mediastinal mass core biopsy and the results were suggestive of a thymic carcinoma. He underwent thymic mass resection and completed four cycles of chemotherapy. Other treatments included radiation and additional chemotherapy with cisplatin, epirubicin, and etoposide when he recurred. He had progression of the disease and his tumor was sent for FoundationOne testing to help guide treatment decision making. The patient has requested reimbursement for FoundationOne testing performed on 12/28/16. The Health Insurer denied this request and reported that the services at issue were investigational for the evaluation of this patients medical condition. | Overturned | Experimental | Summary Reviewer 2
The patient is a 63-year-old male with metastatic thymic cancer, stage IV with pleural dissemination. He was initially diagnosed in November 2014. On 4/29/15, he underwent an anterior mediastinal mass core biopsy and the results were suggestive of a thymic carcinoma. He underwent thymic mass resection and completed four cycles of chemotherapy. Other treatments included radiation and additional chemotherapy with cisplatin, epirubicin, and etoposide when he recurred. He had progression of the disease and his tumor was sent for FoundationOne testing to help guide treatment decision making. The patient has requested reimbursement for FoundationOne testing performed on 12/28/16. The Health Insurer denied this request and reported that the services at issue were investigational for the evaluation of this patients medical condition. Thymic carcinomas are rare epithelial malignancies with no clear therapeutic guidelines beyond first line therapy. Molecular profiling such as with FoundationOne testing offers molecular profiling that can differentiate thymic carcinomas from thymomas by identifying c-KIT mutations. The presence of a c-KIT mutation in thymic cancers has shown benefit to treatment with sunitinib or sorafenib. Molecular profiling can also help to differentiate thymic cancers from lung cancers as pathologically they are similar. As such, molecular profiling with FoundationOne testing performed on 12/28/16 was likely to have been more effective than any available standard therapy for evaluating the patients medical condition. Therefore, for the reasons stated above, the services at issue were likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overtu
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A 51-year-old female enrollee has requested reimbursement for hyperthermia (77605 and 77600) provided from 11/03/15 through 12/15/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees breast cancer. | Upheld | Experimental | Summary Reviewer 3
A 51-year-old female enrollee has requested reimbursement for hyperthermia (77605 and 77600) provided from 11/03/15 through 12/15/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees breast cancer. The physician reviewer found that upon diagnosis with breast cancer, patients have two major surgical options, modified radical mastectomy or lumpectomy followed by radiation therapy. From well-planned clinical trials with numerous patients, it is known that these two surgical approaches offer equivalent overall survival, but there are notable exceptions. Breast conserving surgery does result in increased rates of locoregional recurrence, but this is diminished by the use of radiation therapy to the operative areas postoperatively. However, there are absolute contraindications to lumpectomy. These contraindications include multicentric disease (two or more primaries in separate quadrants of the breast), diffuse microcalcifications, prior history of radiation therapy, pregnancy, and persistent positive margins. This is the case for this patient who had multifocal disease in the right breast. Local hyperthermia to ablate tumors or locoregional recurrence is considered standard care, but its use on a primary breast tumor before mastectomy is unusual. Thus, hyperthermia (77605 and 77600) provided from 11/03/15 through 12/15/15 was not likely to have been more efficacious than other available treatment 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.
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A 45-year-old male enrollee has requested authorization and coverage for Otezla 10-20-30 milligram tablets, starter therapy pack. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition.
. This patient is requesting coverage for Otezla for the treatment of chronic plaque psoriasis. The records document that he has tried and failed therapy with Clobex spray and azithromycin. The Health Insurer has denied the request as not medically necessary as the patient has not tried and failed the formulary preferred agents. | Upheld | Medical Necessity | Summary Reviewer
A 45-year-old male enrollee has requested authorization and coverage for Otezla 10-20-30 milligram tablets, starter therapy pack. 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 submitted documentation fails to demonstrate the medical necessity of the requested medication. This patient is requesting coverage for Otezla for the treatment of chronic plaque psoriasis. The records document that he has tried and failed therapy with Clobex spray and azithromycin. The Health Insurer has denied the request as not medically necessary as the patient has not tried and failed the formulary preferred agents. The submitted records do not indicate a treatment trial or contraindications to the use of methotrexate, cyclosporine, Humira, Enbrel, Cosentyx or Stelara. Thus, there are effective, alternative, formulary preferred agents available for use. Therefore, Otezla 10-20-30 milligram tablets, starter therapy pack is not medically necessary for the treatment of this patient. | 1 |
The parent of a three-year-old male enrollee has requested reimbursement for the FirstStepDx Plus testing performed on 12/14/15. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees autism spectrum disorder. | Overturned | Experimental | Summary Reviewer 2
The parent of a three-year-old male enrollee has requested reimbursement for the FirstStepDx Plus testing performed on 12/14/15. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees autism spectrum disorder. The physician reviewer found that battaglia and colleagues performed a study to demonstrate the usefulness of CMA in detecting the etiology of unexplained autism spectrum disorders associated with dysmorphic features in a large cohort of pediatric patients. The authors concluded that their study confirmed the value of CMA as the first-tier tool in the assessment of those conditions in the pediatric setting. CMA has become the standard of care to evaluate children with developmental delay, intellectual disability, autism spectrum disorders or multiple congenital anomalies. The medical literature supports the testing at issue as an important and mainstream tool in the practice of clinical genetics. Given the support in the peer-reviewed literature, FirstStepDx Plus performed on 12/14/15 has been established as likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 55-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus. | Overturned | Medical Necessity | Summary Reviewer
A 55-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus. The physician reviewer found according to the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) Successful hepatitis C treatment results in sustained virologic response (SVR), which is tantamount to virologic cure, and as such, is expected to benefit nearly all chronically infected persons. Evidence clearly supports treatment in all HCV-infected persons, except those with limited life expectancy (less than 12 months) due to non-liver-related comorbid conditions. In addition, AASLD/IDSA treatment guidelines recommend Harvoni for 12 weeks for treatment-naive patients with HCV genotype 1 infection. Therefore, based on national guidelines Harvoni is medically necessary in this clinical setting.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 50-year-old female enrollee has requested reimbursement for the injection of periurethral bulking agent provided on 12/19/14. The Health Insurer has denied this request indicating that the service at issue was considered investigational for treatment of the enrollees recurrent stress urinary incontinence and intrinsic urethral sphincter deficiency. The physician reviewer found that this patient presents with persistent stress urinary incontinence associated with urgency and urgency incontinence. She underwent multiple procedures which failed. Subsequently, the patient underwent urethral bulking agent injection therapy. The patient did undergo preoperative urodynamics. There was cystoscopy evidence that the patient had urethral hypermobility and the patient also had urgency. However, there was | Overturned | Experimental | Summary Reviewer 1
A 50-year-old female enrollee has requested reimbursement for the injection of periurethral bulking agent provided on 12/19/14. The Health Insurer has denied this request indicating that the service at issue was considered investigational for treatment of the enrollees recurrent stress urinary incontinence and intrinsic urethral sphincter deficiency. The physician reviewer found that this patient presents with persistent stress urinary incontinence associated with urgency and urgency incontinence. She underwent multiple procedures which failed. Subsequently, the patient underwent urethral bulking agent injection therapy. The patient did undergo preoperative urodynamics. There was cystoscopy evidence that the patient had urethral hypermobility and the patient also had urgency. However, there was no evidence of an intrinsic sphincteric deficiency. At this time, the success rate for long-term urethral bulking agent therapy is significantly low and alternative surgical procedures would likely have provided this patient with a superior health outcome. Accordingly, the injection of periurethral bulking agent provided on 12/19/14 was not likely to be more beneficial for treatment of this patients medical condition than any available standard therapy. Based upon the information set forth above, the service at issue was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The parent of a 13-year-old female enrollee has requested reimbursement for transcutaneous electrical modulation pain processing provided from 12/03/18 through 5/14/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 3
The parent of a 13-year-old female enrollee has requested reimbursement for transcutaneous electrical modulation pain processing provided from 12/03/18 through 5/14/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition. The physician reviewer found that Nayback-Beebe and colleagues evaluating the efficacy of Scrambler Therapy on chronic pain. The authors found, The groups showed no statistically significant differences in pain scores, medication use, or mental or physical health-related quality of life with active versus sham treatment. However, both produced clinically meaningful reductions in pain and improvements in physical health-related quality post-treatment that was sustained at 1-month follow-up. The authors concluded, Scrambler Therapy is no better than sham treatment in decreasing pain. Yet, patient perceptions of treatment effectiveness are equally important in chronic pain treatment. Goh and colleagues performed a systematic review on current standards of care for complex regional pain syndrome. The authors described several of the current standard treatments, including physical therapy, psychological treatments, pharmacological therapies, as well as interventional treatments, including sympathetic blockade and surgical approaches. There is no mention of Scrambler Therapy as an accepted treatment for complex regional pain syndrome.
In this case, the patient has complex regional pain syndrome that has not responded to physical therapy or epidural steroid injections. The current evidence supporting the Scrambler Therapy for chronic pain is very limited, with a lack of large randomized control studies to demonstrate clear benefit. Furthermore, there is a lack of studies in the published peer-reviewed literature evaluating the benefits of this therapy specifically for complex regional pain syndrome and showing superiority to standard of care. Thus, transcutaneous electrical modulation pain processing provided from 12/03/18 through 5/14/19 was not likely to have been more beneficial than any available standard therapy.
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A 57-year-old male requested authorization and coverage for implantation of device (the Coflex device) between the bones of the spine. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollees chronic lower back pain. | Upheld | Experimental | Summary Reviewer 3
A 57-year-old male requested authorization and coverage for implantation of device (the Coflex device) between the bones of the spine. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollees chronic lower back pain. The physician reviewer found that the medical literature does not demonstrate the superior benefits of the requested device in this clinical setting. While there is some evidence to indicate that the Coflex interlaminar stabilization implant has been effective, the literature appears to support its use in patients with low grade spinal stenosis. In this patients case, his symptoms are more consistent with high grade or severe spinal stenosis. Further studies are needed in order to demonstrate the superior efficacy of the requested device for patients in this clinical setting. Accordingly, implantation of the Coflex device between the bones of the spine is not likely to be more beneficial than the standard available options for the treatment of this patient. Based upon the information set forth above, the requested device is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 64-year-old female enrollee has requested authorization and coverage for Harvoni for 24 weeks. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus.
, 440 HCV patients underwent randomization and were treated, 20% had cirrhosis and 79% had HCV genotype 1a infection. | Overturned | Medical Necessity | Summary Reviewer
A 64-year-old female enrollee has requested authorization and coverage for Harvoni for 24 weeks. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus. The physician reviewer found Harvoni for 24 weeks is medically necessary for treatment of the patients medical condition. In the ION-2 study, 440 HCV patients underwent randomization and were treated, 20% had cirrhosis and 79% had HCV genotype 1a infection. The rates of sustained virologic response were high in all treatment groups. There was a 99% (95% confidence interval (CI), (95 to 100) in the group that received 24 weeks of ledipasvir-sofosbuvir and 99% (95% CI, 95 to 100) in the group that received 24 weeks of ledipasvir-sofosbuvir and ribavirin (Afdhal, et al). The results of an abstract were presented at the American Association for the Study of Liver Diseases Liver Meeting. In this double-blind study, Bourliere and colleagues randomized 155 patients previously unable to achieve SVR after sequential treatment with a peginterferon and ribavirin regimen followed by a protease-inhibitor (PI), peginterferon and ribavirin regimen, to undergo treatment with ledipasvir/sofosbuvir and ribavirin placebo for 24 weeks or matching placebo for 12 weeks, followed by ledipasvir/sofosbuvir and ribavirin for 12 weeks. Patients were stratified by HCV subtype and their responses to their most recent therapy. Of the 77 patients treated with ledipasvir/sofosbuvir and ribavirin for 12 weeks, 4% experienced relapse; compared with 3% of the 77 patients treated with ledipasvir/sofosbuvir for 24 weeks, for a 3% total incidence of relapse. Based on the peer-reviewed literature, Harvoni for 24 weeks is medically necessary in this clinical setting. 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 57-year-old male requested authorization and coverage for implantation of device (the Coflex device) between the bones of the spine. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollees chronic lower back pain. | Upheld | Experimental | Summary Reviewer 1
A 57-year-old male requested authorization and coverage for implantation of device (the Coflex device) between the bones of the spine. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollees chronic lower back pain. The physician reviewer found that the medical evidence fails to support that the Coflex device, when used under these circumstances, results in any improved outcome when compared to laminectomy alone. Moreover, there are studies that indicate that the Coflex device has to be removed in some cases, either due to infection or displacement due to a fractured spinous process. For these reasons, implantation of the Coflex device between the bones of the spine is not likely to be more effective than the standard available options for the treatment of this patients medical condition. Based upon the information set forth above, the requested device is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 38-year-old male enrollee has requested authorization and coverage for a cardioverter defibrillator. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollee, who has cardiac sarcoidosis.
In this case, the patient has an indication for pacemaker placement, as he has symptomatic second degree atrioventricular block. | Overturned | Experimental | Summary Reviewer 3
A 38-year-old male enrollee has requested authorization and coverage for a cardioverter defibrillator. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollee, who has cardiac sarcoidosis. The physician reviewer found that there is support for the requested device in this patients case. Implantable cardioverter defibrillators are indicated for patients with cardiac sarcoidosis who have an indication for permanent pacemaker placement. In this case, the patient has an indication for pacemaker placement, as he has symptomatic second degree atrioventricular block. Therefore, the requested cardioverter defibrillator is likely to be more efficacious than other treatment options. Based upon the information set forth above, the requested device is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
patient is a 28-year-old female with a history of a prior emergency hysterectomy due to
placenta accreta and postpartum hemorrhage. The patient is requesting coverage for IVF,
intracytoplasmic sperm injection (ICSI), and assisted hatching. The Health Insurer has denied the
services at issue as not medically necessary for the treatment of the patients medical condition.
found that this
patient has requested coverage for IVF, ICSI, and assisted hatching. The records reflect that the
patient underwent a hysterectomy. As the patient does not have a uterus, she will require IVF and
a gestational surrogate in order to have biological children. | Overturned | Medical Necessity | Summary
The patient is a 28-year-old female with a history of a prior emergency hysterectomy due to
placenta accreta and postpartum hemorrhage. The patient is requesting coverage for IVF,
intracytoplasmic sperm injection (ICSI), and assisted hatching. The Health Insurer has denied the
services at issue as not medically necessary for the treatment of the patients medical condition.
This denial is the subject of this appeal and determination. The physician reviewer found that this
patient has requested coverage for IVF, ICSI, and assisted hatching. The records reflect that the
patient underwent a hysterectomy. As the patient does not have a uterus, she will require IVF and
a gestational surrogate in order to have biological children. Regarding ICSI, according to the
American Society for Reproductive Medicine (ASRM) guidelines, in the absence of a male-factor,
ICSI has not been shown to improve live birth outcomes. On the contrary, ICSI may lead to a
decrease in live birth rates. Regarding assisted hatching, one medical study concluded that despite
significantly improved odds of clinical pregnancy, there is insufficient evidence to determine
whether assisted hatching has any effect on live birth rates (Zeng, et al.). The ASRM guidelines
similarly state that laser-assisted hatching should not be routinely recommended for all patients
undergoing IVF. Overall, the patient will require IVF and a gestational surrogate in order to have
biological children. However, there is a lack of documentation indicating that this patient has a
history of male-factor infertility. Therefore, ICSI is not indicated for this patient. Finally, the
current medical literature and guidelines have not shown that assisted hatching is indicated for this
patient. All told, the requested IVF is medically necessary for the treatment of this patient, but the
requested ICSI and assisted hatching are not medically necessary for the treatment of this patient.
| 1 |
A 57-year-old male enrollee has requested reimbursement for orbitotomy without bone flap (right and left) and conjunctivoplasty reconstruction performed on 8/26/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition.
The patient had an unusual presentation of canalicular and orbital infection and did not improve with antibiotic treatment and canalicular debridement. | Overturned | Medical Necessity | Summary Reviewer
A 57-year-old male enrollee has requested reimbursement for orbitotomy without bone flap (right and left) and conjunctivoplasty reconstruction performed on 8/26/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition. The physician reviewer found based on the history of failed conservative management for the patients infection, the surgical exploration and scar release were medically necessary. The patient had an unusual presentation of canalicular and orbital infection and did not improve with antibiotic treatment and canalicular debridement. There is no evidence in the medical literature to suggest additional intravenous antibiotic or other alternative management would be preferable to surgical care for this case where oral antibiotics had already failed. All told, orbitotomy without bone flap (right and left) and conjunctivoplasty reconstruction performed on 8/26/14 were medically indicated for the treatment of this patient. Therefore, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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A 44-year-old male enrollee has requested reimbursement for the allergy immunotherapy treatment provided on 11/2/15. The Health Insurer has denied this request indicating that the medication at issue was not medically necessary for treatment of the enrollees Menieres disease and allergic rhinitis. | Upheld | Medical Necessity | Summary Reviewer
A 44-year-old male enrollee has requested reimbursement for the allergy immunotherapy treatment provided on 11/2/15. The Health Insurer has denied this request indicating that the medication at issue was not medically necessary for treatment of the enrollees Menieres disease and allergic rhinitis. The physician reviewer found that in the medical literature, Cox and colleagues noted that the intervals between maintenance immunotherapy injections generally range for four to eight weeks for venom and every two to four weeks for inhalants allergens but can be advanced as tolerated if clinical efficacy is maintained. In this case, the patient should be well into the maintenance phase, which does not require weekly injections. At times, providers will decrease doses if doses are missed, there are adverse reactions, or during pollen season. Larenas-Linnemann and colleagues report that doses are reduced when a patient comes in more than 14 days for five weeks after the last administration and initial dosing restarted after more than 30 days for 12 weeks since last administration during the build-up or maintenance stage. After missing one to three doses, the dosing schedules were mostly followed (build-up phase: repeat last dose, reduce by one dose, reduce by two doses; maintenance phase: reduce by one dose, reduce by two doses, reduce by three doses). For this patient, there is no evidence of missed doses, adverse events or other issues with allergy injections. As such, allergy immunotherapy treatment provided on 11/2/15 was not medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the medication at issue was not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 49-year-old female has requested authorization and coverage for 22857 [total disc
arthroplasty (artificial disc), two-day inpatient stay]. The Health Insurer has
denied this request and reported that the requested services are investigational for
the treatment of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 3
A 49-year-old female has requested authorization and coverage for 22857 [total disc
arthroplasty (artificial disc), two-day inpatient stay]. The Health Insurer has
denied this request and reported that the requested services are investigational for
the treatment of the enrollees medical condition. The physician reviewer found that
total disc replacement is an effective alternative to fusion for lumbar degenerative
disc disease that offers several clinical long-term advantages over single-level
arthrodesis including sparing adjacent levels from eventual deterioration, long-term
durability without significant loosening or adverse effects from wear debris, motion preservation, fewer re-operations, shorter operating and hospitalization times,
fewer complications, and better patient reported outcomes in terms of greater
satisfaction, less pain, and less disability. The FDA approved the use of single
level lumbar disc replacement in 2006 and expanded approval for two-level lumbar
disc replacement in 2020, based on good mid-term results with the ProDisc-L implant.
In a meta-analysis including four studies, Zigler and colleagues reported that
patients with total disc replacement had a significantly greater likelihood of
Oswestry Disability Index (ODI) success, patient satisfaction, and a significantly
lower risk of reoperation than fusion patients. Based on a meta-analysis, Li and
colleagues suggest that total disc replacement could be an alternative treatment for
lumbar degenerative disc disease due to yielding better clinical success including
patient satisfaction, shorter hospitalization and operative times, less pain, and
lower complication rates than lumbar fusion. Bai and colleagues report that while
lumbar fusion is considered the gold standard for treatment of spinal degenerative
diseases, it may result in adjacent segment degeneration and acquired spinal
instability while total disc replacement avoids the occurrence of these
complications. In a meta-analysis of 14 randomized, controlled trials, the authors
concluded that compared to lumbar fusion, total disc replacement significantly
improved ODI, visual analog scale (VAS), and short form-36 (SF-36) health
questionnaire scores, patient satisfaction, overall success, reoperation rate,
reduced operation time, shortened duration of hospitalization and decreased
postsurgical complications. Rasouli and colleagues concluded in a clinical and
radiographic analysis of 159 patients that multilevel lumbar total disc replacement
demonstrated persistent good results, preservation of motion, and absence of
adjacent segment disease at a follow-up of six years. While total disc replacement
surgery may be contraindicated in patients with spinal infection, osteoporosis,
allergy or sensitivity to implant materials, spondylolisthesis, spinal tumor,
pregnancy, use of steroids for long duration, previous spinal surgery and the
morbidly obese, the submitted records do not show that any of these
contraindications apply to this patient. Current medical literature does not mention
mild, non-degenerative scoliosis as a contraindication to lumbar disc replacement,
and the patient is not noted as having significant degenerative scoliosis. The
records did not note abnormal bone density, spinal instability, or
spondylolisthesis. The L4-L5 disc was severely involved, with other levels being
well preserved. Therefore, 22857 [total disc arthroplasty (artificial disc), two-day
inpatient stay] is likely to be more beneficial for treatment of the patient's
condition than any available standard therapy. | 1 |
A 28-year-old male enrollee has requested reimbursement for ColonSentry testing (CPT code 81479) performed on 10/23/14. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 3
A 28-year-old male enrollee has requested reimbursement for ColonSentry testing (CPT code 81479) performed on 10/23/14. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees medical condition. The physician reviewer found based on the documentation submitted for review, the patient may be in a family with Lynch syndrome. However, there is no specific genetic determination that the patient carries the Lynch genetics. Lynch syndrome (hereditary nonpolyposis colorectal cancer) is an autosomal dominant genetic abnormality that brings with it increased risk of multiple types of cancer, including colon cancer, endometrial cancer, and others. Because of this there are recommended programs of surveillance that have been recommended. In relation to colon cancer, affected patients should have colonoscopy every 1-2 years (Lindor, et al). The ColonSentry blood test measures the expression of seven genes whose expression is associated with colorectal cancer. Its purpose is to indicate to a patient his relative risk of the development of colon cancer. However, there is a lack of significant data as yet, to demonstrate any benefit to this test and it is not U.S. Food and Drug Administration (FDA) approved. In addition, it is not included within national guidelines for colorectal cancer screening (Levin, et al). There is also a lack of data to indicate that it provides meaningful data in the management of those with Lynch syndrome. In this case, the patient underwent colonoscopy surveillance, and there is no benefit to the additional use of ColonSentry testing. As such, the ColonSentry testing (CPT code 81479) performed on 10/23/14 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 |
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 has significant bipolar cartilage lesions in her knee in the patellofemoral joints bilaterally. | Overturned | Experimental | Summary Reviewer 3
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 there is a lack of support for the services at issue in this clinical setting. This patient has significant bipolar cartilage lesions in her knee in the patellofemoral joints bilaterally. There is a lack of evidence supporting autologous chondrocyte implantation for a bipolar lesion. Ogura and colleagues performed a study without a control group that addressed using autologous implantation for a bipolar lesion. However, without a control group, definitive conclusions cannot be drawn. The current standard would be a patellofemoral arthroplasty. Thus, autologous cultured chondrocyte implantation in the knee is not likely to be more beneficial than other treatment options.
| 1 |
This patient is documented to have daily migraine that has been refractory to standard migraine medications. | Overturned | Experimental | Summary Reviewer 3
[INSERT FIRST TWO SENTENCES FROM SUMMARY REVIEW DETERMINATION] The physician reviewer found that botox is a U.S. Food and Drug Administration (FDA) approved treatment for the treatment of migraines (Escher, et al). Botox is indicated for the treatment of chronic headaches in patients who have at least 14 headache days per month. In the peer-reviewed medical literature, Aurora and colleagues concluded that repeat treatment with five or fewer cycles of Botox was effective, safe, and well tolerated in adults with chronic migraine. This patient is documented to have daily migraine that has been refractory to standard migraine medications. Based on a review of the patients medical records and the current medical literature, the Botox injections (CPT code 64615) provided on 5/26/17, 8/25/17, and 11/17/17 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 patient is a 55-year-old male who fell down a flight of stairs on 3/10/18, injuring his left shoulder, left hip, and lower back. He was evaluated in urgent care the next day. There was limitation of motion and pain in the left shoulder. X-rays did not reveal any fractures. Evaluation by primary care provider on 3/16/18 revealed limited motion and pain in the shoulder. Orthopedic referral and magnetic resonance imaging (MRI) scan was advised to rule out a rotator cuff tear. An orthopedic surgeon concurred with the recommendation for an MRI scan of the shoulder. The Plan denied the request for shoulder MRI as four weeks of stretching exercises had not been documented. The patient has requested authorization and coverage for MRI scan because of the acute injury, limitation of range of motion and continuing pain to rule out a rotator cuff tear. The Health Insurer has denied this request indicating that the requested services are not medically necessary for the evaluation of the patient. This denial
. The patient has sustained significant acute trauma to the left shoulder as a result of a fall down a flight of stairs. X-rays have been | Overturned | Medical Necessity | Summary Reviewer
The patient is a 55-year-old male who fell down a flight of stairs on 3/10/18, injuring his left shoulder, left hip, and lower back. He was evaluated in urgent care the next day. There was limitation of motion and pain in the left shoulder. X-rays did not reveal any fractures. Evaluation by primary care provider on 3/16/18 revealed limited motion and pain in the shoulder. Orthopedic referral and magnetic resonance imaging (MRI) scan was advised to rule out a rotator cuff tear. An orthopedic surgeon concurred with the recommendation for an MRI scan of the shoulder. The Plan denied the request for shoulder MRI as four weeks of stretching exercises had not been documented. The patient has requested authorization and coverage for MRI scan because of the acute injury, limitation of range of motion and continuing pain to rule out a rotator cuff tear. The Health Insurer has denied this request indicating that the requested services are not medically necessary for the evaluation of the patient. This denial is the subject of this appeal and determination. The patient has sustained significant acute trauma to the left shoulder as a result of a fall down a flight of stairs. X-rays have been negative for fractures. However, the pain and limitation of motion persists. Traumatic pain may result from a fracture or soft tissue injury, most commonly to the rotator cuff. Imaging starts with x-rays and depending on physical examination findings, as next steps, an MRI or MR arthrography for assessment of soft tissue injuries may be required. In light of the persisting pain, a month after the injury, the MRI is appropriate according to American College of Radiology appropriateness Criteria (Amini, et al). The nature of the acute trauma, continuing pain, and the physical examination findings are considered to establish an accurate diagnosis in a timely fashion and achieve an optimal result from any surgical intervention that may be necessary in an active individual. A more aggressive management and diagnostic strategy may identify those in need of early operative intervention and provide robust rehabilitation programs. As such, in this patients case the requested MRI scan has been demonstrated as medically necessary for the evaluation of this patients medical condition. Therefore, based on the reasons stated above, the requested services are medically necessary for the evaluation of this patients medical condition. The Health Insurers denial should be overturned.
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A 21-year-old female enrollee has requested authorization and coverage for Octagam infusions. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrolleeas medical condition.
. The patient in question carries several diagnoses, including autonomic nervous system dysfunction. Per the records, this patient has a suspicion of Spiky-Leaky syndrome. Xie and colleagues | Upheld | Experimental | Summary Reviewer 3
A 21-year-old female enrollee has requested authorization and coverage for Octagam infusions. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that the autonomic nervous system regulates certain body processes, such as blood pressure and the rate of breathing. This system works automatically (autonomously), without a personas conscious effort. Disorders of the autonomic nervous system can affect any body part or process. Autonomic disorders may be reversible or progressive. Intravenous immunoglobulin is an immunological treatment. The patient in question carries several diagnoses, including autonomic nervous system dysfunction. Per the records, this patient has a suspicion of Spiky-Leaky syndrome. Xie and colleagues stated that IVIG may be considered with a clear-cut diagnosis. However, the diagnosis is just suspected in this patient. The study by Weinstock and colleagues would not apply to this patient, as there is a lack of evidence submitted for this review to support a diagnosis of postural orthostatic tachycardia syndrome or the concurrent use of naltrexone in this case. There is a lack of evidence supporting IVIG as more efficacious than other available standard therapy in this clinical setting. Therefore, Octagam infusions are not likely to be more beneficial than any available standard therapy.
| 1 |
A 36-year-old male enrollee has requested authorization and coverage for epidural steroid injections. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees degenerative spondylosis and disc disease. | Upheld | Medical Necessity | Summary Reviewer
A 36-year-old male enrollee has requested authorization and coverage for epidural steroid injections. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees degenerative spondylosis and disc disease. The physician reviewer found that in the documentation available for review, the patients records do not demonstrate that he been treated with physical therapy even though it was recommended by his provider. Physical therapy with active exercise is indicated in this clinical setting. Further, the medical literature suggests that a home exercise program after physical therapy independent of an epidural injection can provide lasting results. Moreover, the patient does not have any recent physical exam findings or imaging studies to support a diagnosis of lumbar radiculopathy, which would be one indication for epidural steroid injections (Manchikanti, et al; Kaye, et al). Given the available records, there are standard treatment options for low back pain that have not been performed (Hooten and Cohen; Derby, et al). Given these findings, the requested epidural steroid injections are not medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the requested services are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 52-year-old male enrollee has requested authorization and coverage for olaparib (Lynparza) tablet 100 mg. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees prostate cancer.
. This patient was found to have the FANCA mutation, which is a related type of mutation. | Upheld | Experimental | Summary Reviewer 1
A 52-year-old male enrollee has requested authorization and coverage for olaparib (Lynparza) tablet 100 mg. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees prostate cancer. The physician reviewer found that Lynparza has been approved for use in patients with BRCA positive breast cancer or ovarian cancer. There is early experience with Lynparza in prostate cancer, mostly demonstrating some efficacy only in patients with DNA repair mutations, such as BRCA or ATM (Sonnenburg and Morgans). This patient was found to have the FANCA mutation, which is a related type of mutation. However, thus far, there is a lack of data demonstrating that patients with this mutation will obtain a meaningful response to Lynparza. Clarke and colleagues suggested that regardless of mutation status, there is somewhat better progression free survival with a combination of Lynparza and abiraterone than with abiraterone alone, though there was considerable toxicity in the combination arm. Given these findings, the requested Lynparza tablet 100 mg is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested 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 64-year-old female has requested reimbursement for FoundationOne testing performed on 1/13/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 2
A 64-year-old female has requested reimbursement for FoundationOne testing performed on 1/13/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the submitted documentation fails to demonstrate the superior efficacy of the services at issue. Carcinosarcoma is an aggressive uterine cancer often treated similar to high-grade endometrial cancer. Per the medical evidence, molecular genetics on individual tumors has not yet been shown to be fruitful in the majority of cases. This testing is not recommended as a standard of care for the treatment of uterine cancers per the current guidelines. In sum, FoundationOne testing performed on 1/13/16 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.
| 0 |
A 67-year-old male enrollee has requested authorization and coverage for sacroiliac joint fusion. The Health Insurer has denied this request indicating that the requested service is considered investigational for treatment of the enrollees bilateral sacroiliac joint pain status post revision lumbar surgery.
that this patient presents with persistent severe left greater than right SI joint pain. Functional difficulty was documented with activities of daily living and ambulation. He is status post multiple lumbar fusion surgeries resulting in L3-4, L4-5 and L5-S1 interbody fusion with posterior instrumentation from L3 to S1. He has reported progressively worsening bilateral SI joint pain following the last surgery on 11/1/16.
. Clinical examination findings have documented SI joint tenderness with three positive SI provocative tests. In addition, there is radiographic evidence of SI joint sacroiliitis. | Upheld | Experimental | Summary Reviewer 3
A 67-year-old male enrollee has requested authorization and coverage for sacroiliac joint fusion. The Health Insurer has denied this request indicating that the requested service is considered investigational for treatment of the enrollees bilateral sacroiliac joint pain status post revision lumbar surgery. The physician reviewer found that this patient presents with persistent severe left greater than right SI joint pain. Functional difficulty was documented with activities of daily living and ambulation. He is status post multiple lumbar fusion surgeries resulting in L3-4, L4-5 and L5-S1 interbody fusion with posterior instrumentation from L3 to S1. He has reported progressively worsening bilateral SI joint pain following the last surgery on 11/1/16. There is evidence of long-term conservative treatment including medications, cane/walker use, bracing, activity modification, SI joint injections, home exercise program, and physical therapy without sustained improvement. Clinical examination findings have documented SI joint tenderness with three positive SI provocative tests. In addition, there is radiographic evidence of SI joint sacroiliitis. Moreover, bilateral SI joint injections have been documented with 90-100% temporary pain relief. Current evidence based medical guideline and peer-reviewed surgical indications for SI joint fusion have therefore been met. Accordingly, the requested SI joint fusion is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested service 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 53-year-old female enrollee has requested reimbursement for gene testing performed on 7/5/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees bilateral thyroid nodules.
. In this case, the patient presented with bilateral thyroid nodules. The dominant nodule on the lower right lobe measuring 1.6 cm in largest diameter showed suspicious features in the thyroid ultrasound. The cytopathology of the 1.6 cm thyroid nodule was consistent with follicular neoplasm. The other nodule showed benign cytopathology. | Overturned | Experimental | Summary Reviewer 3
A 53-year-old female enrollee has requested reimbursement for gene testing performed on 7/5/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees bilateral thyroid nodules. The physician reviewer found that the gene testing performed on 7/5/16 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. In this case, the patient presented with bilateral thyroid nodules. The dominant nodule on the lower right lobe measuring 1.6 cm in largest diameter showed suspicious features in the thyroid ultrasound. The cytopathology of the 1.6 cm thyroid nodule was consistent with follicular neoplasm. The other nodule showed benign cytopathology. The American Thyroid Associations guidelines state that for follicular neoplasm nodules, molecular testing may be used to supplement malignancy risk assessment data in lieu of proceeding directly with surgery. Informed patient preference and feasibility should be considered in clinical decision-making (Haugen, et al). If the genetic test is suspicious, the risk of malignancy increases to 40% (Haugen, et al; Alexander, et al). However, the risk of malignancy decreases to less than 6% with benign findings by genetic testing (Haugen, et al; Alexander, et al). The test is therefore beneficial for the medical decision making. In this case, the result of the gene expression classifier was suspicious for malignancy. This result was helpful to direct subsequent management and a hemithythyroidectomy was recommended. All told, genetic testing was appropriate, in line with current specialty standards and 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 67-year-old male enrollee has requested reimbursement for clonoSEQ assay test performed on 9/13/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. | Overturned | Experimental | Summary Reviewer 1
A 67-year-old male enrollee has requested reimbursement for clonoSEQ assay test performed on 9/13/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that per the National Comprehensive Cancer Network guidelines, aEarly referral for high-dose therapy with stem cell rescue is advisable for planning purposes.a Achievement of minimal residual disease (MRD) negativity is associated with improved clinical response. The amount of MRD also guides eligibility for autologous transplant and clinical trials. Multiple studies currently recruiting for mantle cell lymphoma require measurement of MRD to determine eligibility for enrollment. There is sufficient evidence for the services at issue in this clinical setting. Therefore, clonoSEQ assay test performed on 9/13/20 was likely to have been more beneficial for the evaluation of the patient than any available standard therapy.
| 0 |
The parent of a 17-year-old female enrollee has requested reimbursement for residential treatment center services provided from 10/16/15 through 5/31/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition.
the stress of the patients family was continuing to trigger most of her symptoms, including depression, suicidal thoughts, disordered eating pattern and PTSD. | Overturned | Medical Necessity | Summary Reviewer
The parent of a 17-year-old female enrollee has requested reimbursement for residential treatment center services provided from 10/16/15 through 5/31/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found the RTC services provided from 10/16/15 through 5/31/16 was medically necessary for treatment of the patients medical condition. Based on the documentation provided for review, the stress of the patients family was continuing to trigger most of her symptoms, including depression, suicidal thoughts, disordered eating pattern and PTSD. It was an essential component of this patients therapy that she be removed from the home and provided a safe, structured and supportive environment 24-hours per day. Only by being removed from the home could she begin to work on her own issues in individual and group therapy. During this time, family therapy continued allowing her to very slowly develop a relationship with her parent, with whom she would live after discharge. Given the above, the services at issue were medically necessary for treatment of the patients medical condition. Therefore, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 48-year-old female has requested reimbursement for genotyping for CYP2D6 polymorphism performed on 7/10/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 1
A 48-year-old female has requested reimbursement for genotyping for CYP2D6 polymorphism performed on 7/10/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found there is a lack of evidence supporting the services at issue in this clinical setting. The National Comprehensive Cancer Network does not recommend routine testing for CYP2D6 genotype in women being considered for tamoxifen therapy. This issue has been retrospectively examined in a postmenopausal population of women, in which investigators found no difference in outcome according to CYP2D6 genotype. Moreover, the superior benefit of this screening in premenopausal women has not been established. Per the medical evidence, the superior efficacy of genotyping for CYP2D6 polymorphism performed on 7/10/14 has not been demonstrated. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 63-year-old male enrollee has requested reimbursement for the wearable cardioverter defibrillator provided on 11/5/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition.
as the patient presented with underlying COPD and a new diagnosis of severe symptomatic congestive heart failure, and LV dysfunction.
In this particular clinical situation, the patient had a severely depressed ejection fraction and needed further aggressive ongoing medical treatment of both congestive heart failure and COPD, which further delayed the planned cardiac mitral and aortic valve replacement surgery. | Overturned | Experimental | Summary Reviewer 3
A 63-year-old male enrollee has requested reimbursement for the wearable cardioverter defibrillator provided on 11/5/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition. The physician reviewer found that the wearable cardioverter defibrillator (LifeVest) was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. In this case, the placement of a wearable cardioverter defibrillator was clinically indicated as the patient presented with underlying COPD and a new diagnosis of severe symptomatic congestive heart failure, and LV dysfunction. There is scientific literature of large case series, prospective registries, and from expert opinion supporting the services at issue. In this particular clinical situation, the patient had a severely depressed ejection fraction and needed further aggressive ongoing medical treatment of both congestive heart failure and COPD, which further delayed the planned cardiac mitral and aortic valve replacement surgery. All told, the wearable cardioverter defibrillator was indicated in this particular short-term clinical situation with support in the medical literature, until both the planned surgical and medical treatments for congestive heart failure could be optimized and the LV function could be reassessed. 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.
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A 59-year-old female enrollee has requested reimbursement for the Veracyte Afirma genetic testing provided on 12/3/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees thyroid nodule. | Overturned | Experimental | Summary Reviewer 1
A 59-year-old female enrollee has requested reimbursement for the Veracyte Afirma genetic testing provided on 12/3/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees thyroid nodule. The physician reviewer found that while a FNA biopsy of a suspicious thyroid nodule is typically an accurate means of assessing whether the nodule is benign or malignant, approximately 15% of FNA biopsy results are considered to be indeterminate (Alexander, et al). Until recently, the only way to establish whether the nodule was in fact thyroid cancer was via surgical excision even though the majority of the cases turn out to be benign (Miller, et al). A newer test, the Afirma Thyroid FNA Analysis from Veracyte utilizes a gene expression classifier in order to help determine the likelihood of malignancy of nodules with indeterminate cytology on FNA biopsy, thereby decreasing the need for unnecessary surgeries. Because it is very sensitive and has a high negative predictive value, a negative Afirma result is rather suggestive of a benign nodule and can therefore preclude such surgical procedures (Duick, et al). Based on these findings, the Veracyte Afirma genetic testing performed on 12/3/14 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, I have determined the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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The parent of a four-year-old male enrollee has requested reimbursement for the polymerase chain reaction (PCR) testing and homocysteine testing performed on 6/4/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees risk for methylenetetrahydrofolate (MTHFR), Factor V Leiden, and homocysteine mutations. | Upheld | Experimental | Summary Reviewer 1
The parent of a four-year-old male enrollee has requested reimbursement for the polymerase chain reaction (PCR) testing and homocysteine testing performed on 6/4/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees risk for methylenetetrahydrofolate (MTHFR), Factor V Leiden, and homocysteine mutations. The physician reviewer found that in the evaluation of thrombophilia, providers frequently conduct MTHFR polymorphism testing, as it has been hypothesized that reduced enzyme activity of MTHFR leads to hyperhomocysteinemia which results in an increased risk for venous thromboembolism, coronary heart disease, and recurrent pregnancy loss. According to the American College of Medical Genetics and Genomics, recent meta-analyses have disproven an association between hyperhomocysteinemia and risk for coronary heart disease and between MTHFR polymorphism status and risk for venous thromboembolism (Hickey, et al). These findings have led the American College of Medical Genetics and Genomics to state that there is growing evidence that MTHFR polymorphism testing has minimal clinical utility and, therefore should not be ordered as a part of a routine evaluation for thrombophilia (Hickey, et al). For these reasons, the American Congress of Obstetricians and Gynecologists does not recommend the measurement of homocysteine or MTHFR polymorphisms in the evaluation of the etiology of venous thromboembolism (Lockwood, et al). In this case, the mother of the patient was found to have a homozygous A1298C mutation in MTHFR. However, it does not appear that this finding alone accounts for mothers recurrent deep venous thromboses during pregnancy. Moreover, the testing performed in this patient is not supported in the current peer-reviewed medical literature. All told, the PCR testing and homocysteine testing performed on 6/4/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 52-year-old male enrollee has requested reimbursement for optical endomicroscopy performed on 5/30/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 1
A 52-year-old male enrollee has requested reimbursement for optical endomicroscopy performed on 5/30/18. 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 Confocal laser endomicroscopy (CLE) is based upon the principle of illuminating a tissue with a low-power laser and then detecting fluorescent light reflected from the tissue. The laser is focused at a specific depth, and only light reflected back from that plane is refocused and able to pass through the pinhole confocal aperture. As a result, scattered light from above and below the plane of interest is not detected, increasing spacial resolution. The area being examined is scanned in the horizontal and vertical planes, and an image is reconstructed. In this manner, microscopic imaging of biological tissue in vivo is possible due to the high lateral resolution of confocal imaging. Since CLE relies upon tissue fluorescence, intravenous and/or topically applied contrast agents are required. The current medical evidence has not demonstrated the superior efficacy of the services at issue in this clinical setting. At this time, the standard of care is to base management decisions on actual biopsy specimens. Therefore, optical endomicroscopy performed on 5/30/18 was not likely to have been of greater benefit than other methods of evaluating this patient.
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A 64-year-old female has requested reimbursement for DecisionDx-Melanoma assay provided on 3/21/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. | Upheld | Experimental | Summary Reviewer 2
A 64-year-old female has requested reimbursement for DecisionDx-Melanoma assay provided on 3/21/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that melanoma is a cancer that is curable in its earliest stages. Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76-1.0 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 the DecisionDx-Melanoma assay 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. In sum, DecisionDx-Melanoma assay provided on 3/21/18 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 54-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 6/01/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 2
A 54-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 6/01/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found in this patients case, the services at issue were likely to have been more effective than other available modalities. The addition of the technique has gained worldwide popularity among radiologists due to an associated decrease in callbacks and increase in detection of small cancers. Tomosynthesis helps in the elimination of confusing overlapping glandular tissue particularly in dense and heterogeneously dense breast tissue, which in turn allows for a more definitive assessment of the breast parenchyma. Thus, digital breast tomosynthesis performed on 6/01/15 was likely to have been more beneficial than other methods of evaluation. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 58-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 2/20/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. | Upheld | Experimental | Summary Reviewer 2
A 58-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 2/20/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that the submitted documentation fails to demonstrate the superior efficacy of the services at issue. The treatment of this patient would not change based on the results of this testing. There is a lack of scientific evidence permitting conclusions concerning the effect of this test on health outcomes. The test is not considered routine standard of care. There is a paucity of published data to support its routine use currently. At this time, there is a need for clinical trials to determine the utility of the results of the test to effect health outcomes. In sum, DecisionDx-Melanoma testing performed on 2/20/18 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.
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A 56-year-old male enrollee has requested reimbursement and prospective authorization and coverage for J1602, Simponi 50 mg, injected monthly for one year from 9/20/18 forward. The Health Insurer has denied this request indicating that the medication at issue was and is considered investigational for treatment of the enrollees autoimmune hearing loss. | Upheld | Experimental | Summary Reviewer 1
A 56-year-old male enrollee has requested reimbursement and prospective authorization and coverage for J1602, Simponi 50 mg, injected monthly for one year from 9/20/18 forward. The Health Insurer has denied this request indicating that the medication at issue was and is considered investigational for treatment of the enrollees autoimmune hearing loss. The physician reviewer found that autoimmune inner ear disease is sensorineural hearing loss, caused by an abnormal immune system response. The clinical expression of immune-mediated inner ear disease typically benefits from steroid and immunosuppressive therapy. There are no standardized diagnostic criteria or reliable diagnostic tests for the diagnosis of autoimmune inner ear disease. The diagnosis is based on exclusion. The safety and efficacy of intratympanically injected golimumab for patients with autoimmune inner ear disease was evaluated by Derebery and colleagues. While the study was limited, there were no serious adverse events. There is support for the medication at issue for the treatment of this patient who is no longer responsive to Imuran, Atabrine, or azulfidine. Thus, J1602, Simponi 50 mg, injected monthly for one year from 9/20/18 forward was and is likely to be more efficacious than other treatment options. Based upon the information set forth above, the medication at issue was and is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 44-year-old female enrollee has requested reimbursement for BRCA testing performed on 3/17/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees risk of cancer. | Upheld | Experimental | Summary Reviewer 1
A 44-year-old female enrollee has requested reimbursement for BRCA testing performed on 3/17/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees risk of cancer. The physician reviewer found that the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Screening patients with no personal history of breast cancer is indicated when an individual has a family history of one or more of the following: a blood relative with a known mutation in a gene that increases cancer risk, a blood relative with two or more primary breast cancers, two or more relatives with breast cancer on the same side of the family with at least one diagnosed before age 50, a blood relative with ovarian cancer, a close blood relative with breast cancer before age 45, a blood relative with male breast cancer or anyone of Ashkenazi Jewish ancestry with breast, ovarian, or pancreatic cancer at any age. The patient does not meet criteria for the BRCA testing performed on 3/17/16. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 59-year-old female enrollee has requested reimbursement for HCMNext Reflex-Ambry genetic test performed on 10/2/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollee, who has a history of hypertrophic cardiomyopathy.
the records provided the patient has been diagnosed with hypertrophic cardiomyopathy by echocardiography. The patient also has a 22-year-old son. | Overturned | Experimental | Summary Reviewer 1
A 59-year-old female enrollee has requested reimbursement for HCMNext Reflex-Ambry genetic test performed on 10/2/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollee, who has a history of hypertrophic cardiomyopathy. The physician reviewer found that based on the records provided the patient has been diagnosed with hypertrophic cardiomyopathy by echocardiography. The patient also has a 22-year-old son. In this circumstance, the use of genetic testing in the proband (patient) is supported in the medical literature in order to determine the presence of any gene defect that may be then tested for in the son and other family members who may be at risk. If a gene mutation known to cause hypertrophic cardiomyopathy is identified in the proband, then this can be used as definitive screening of family members without the need for serial testing with less accurate imaging tests such as serial echocardiography or cardiac magnetic resonance imaging. Current guidelines recommend genetic screening of a proband with hypertrophic cardiomyopathy. As such, HCMNext Reflex-Ambry Genetics test on 10/2/17 was likely to have been more beneficial than the standard options available for evaluating this patient.
Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 66-year-old female enrollee has requested reimbursement for Guardant360 testing performed on 8/10/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees lung adenocarcinoma. | Overturned | Experimental | Summary Reviewer 3
A 66-year-old female enrollee has requested reimbursement for Guardant360 testing performed on 8/10/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees lung adenocarcinoma. The physician reviewer found that the therapy of advanced non-small cell lung cancer has been revolutionized by the finding of epidermal growth factor receptor (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. The mutational landscape of non-small cell lung cancer has significantly expanded in the past two to three years to encompass gain of function in multiple oncogenes with major prognostic and therapeutic consequences. Patients on targeted therapy may develop resistance to erlotinib, and this may be appreciated at the genetic level by recognition of new mutations or amplifications in parallel signal transduction pathways. The Guardant360 test is a liquid biopsy that analyzes patient plasma for mutations in a panel of 70 genes. Von Hoff and colleagues performed a clinical study directly comparing the use of targeted agents with conventional chemotherapy approaches. The study involved 86 patients, and the progression-free survival on regimen selected by molecular profiling was compared to the progression-free survival on the last chemotherapy regimen. The regimen selected by molecular profiling offered a 27% survival advantage. This trial has significant results for patients with stage IV tumors. In this patients case, the results from molecular profiling may offer a rational selection of the next regimen. Thus, Guardant360 testing performed on 8/10/17 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.
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A 53-year-old female enrollee has requested authorization and coverage for fenofibric acid DR. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hypertriglyceridemia.
. This patient has a history of Crohns disease, severe hypertriglyceridemia leading to pancreatitis and documented intolerance/ineffectiveness to several medications including fenofibrate at doses ranging from 48 mg to 145 mg. She is now tolerating a related medication (fenofibric acid 135 mg DR) that is also | Overturned | Medical Necessity | Summary Reviewer
A 53-year-old female enrollee has requested authorization and coverage for fenofibric acid DR. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hypertriglyceridemia. The physician reviewer found that the submitted documentation supports the medical necessity of the requested medication. This patient has a history of Crohns disease, severe hypertriglyceridemia leading to pancreatitis and documented intolerance/ineffectiveness to several medications including fenofibrate at doses ranging from 48 mg to 145 mg. She is now tolerating a related medication (fenofibric acid 135 mg DR) that is also effective at lowering triglyceride levels. Her condition is life-threatening. Thus, it would be unsafe to trial the fenofibrate doses on the Health Insurers preferred formulary. In addition, there is improved bioavailability with the patients current fenofibric acid medication that may be important given her partial small bowel resection and colectomy. In summary, given the patients life threatening condition, trials and intolerance/ineffectiveness of several fenofibrates, stability and effectiveness on current medication and potential advantages of her current medication over formulary alternatives, the requested fenofibric acid DR 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 |
An 81-year-old male enrollee has requested reimbursement for Oncotype DX Prostate testing performed on 7/23/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. | Upheld | Experimental | Summary Reviewer 2
An 81-year-old male enrollee has requested reimbursement for Oncotype DX Prostate testing performed on 7/23/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that once prostate cancer is diagnosed in a pathologic specimen, risk stratification is performed by the analysis of certain features, such as the grade of tumor and PSA level. This helps guide the most appropriate therapy for patients taking into account their age and comorbidities because many patients will not require therapy (i.e. surgery or radiation) and may be followed closely instead. Most clinical variables have not been analyzed in prospective clinical trials. The important features to recognize are Gleason score and PSA, but these are imperfect. Thus, current biomarkers are inadequate for risk stratification, and better prognostic biomarkers are needed. Oncotype DX Prostate testing is a gene expression analysis of target genes in the biopsy specimen that generates a genomic prostate score (GPS). A validation study was presented at the American Urological Association meeting in 2013 involving 395 patients (1-3). The GPS identified patients that had very low risk disease that could be followed rather than referred for surgery. The current prognostic features are inadequate to make firm recommendations regarding active surveillance to patients. Oncotype DX Prostate testing is an appropriate test in this context. Therefore, Oncotype DX Prostate testing performed on 7/23/20 was likely to have been more beneficial than other methods of evaluating this patient.
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A 46-year-old female enrollee has requested reimbursement for injection of platelet-rich plasma performed on 12/21/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition.
that this patient presented in December 2018 with chronic bilateral heel pain. She was diagnosed with bilateral plantar fasciitis. She had reportedly failed conservative treatment, including steroid injections, orthotics, stretching, rest, ice, elevation, therapy, activity modification, and shoe modifications. On 12/21/18, she underwent bilateral platelet-rich plasma injections to the plantar fascia medial and central bands. | Upheld | Experimental | Summary Reviewer 1
A 46-year-old female enrollee has requested reimbursement for injection of platelet-rich plasma performed on 12/21/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition. The physician reviewer found that this patient presented in December 2018 with chronic bilateral heel pain. She was diagnosed with bilateral plantar fasciitis. She had reportedly failed conservative treatment, including steroid injections, orthotics, stretching, rest, ice, elevation, therapy, activity modification, and shoe modifications. On 12/21/18, she underwent bilateral platelet-rich plasma injections to the plantar fascia medial and central bands. There is a lack of large volume, long-term, peer-reviewed outcome studies to support this treatment in this patients case. Therefore, injection of platelet-rich plasma performed on 12/21/18 was not likely to have been more effective than other treatment options.
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A 50-year-old female enrollee has requested reimbursement for residential substance abuse rehabilitation services provided from 7/25/14 through 8/23/14. 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.
. In this case, the patient was motivated to seek alternative options to treatment in order to reduce her recently prescribed sedating medications. According to the records, although the relationship dynamics were strained, the patient had a safe residence and supportive family. Her physical examination upon presentation was reassuring and her provider determined that detoxification was not necessary. She was seeing a psychiatrist in the community. The patient had no history of suicidality and the diagnosis of bipolar illness was not substantiated in the records provided. | Upheld | Medical Necessity | Summary Reviewer
A 50-year-old female enrollee has requested reimbursement for residential substance abuse rehabilitation services provided from 7/25/14 through 8/23/14. 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 upon review of the submitted documentation the medical necessity of residential treatment services provided from 7/25/14 through 8/23/14 has not been established. In this case, the patient was motivated to seek alternative options to treatment in order to reduce her recently prescribed sedating medications. According to the records, although the relationship dynamics were strained, the patient had a safe residence and supportive family. Her physical examination upon presentation was reassuring and her provider determined that detoxification was not necessary. She was seeing a psychiatrist in the community. The patient had no history of suicidality and the diagnosis of bipolar illness was not substantiated in the records provided. Further, the records do not demonstrate the patient had failed a less restrictive treatment setting, such as partial hospitalization or an intensive outpatient program, during the episode of illness. This is significant in this case for two reasons: first, current psychiatric practice favors treatment in the community as outcome measures and therapeutic gains are optimized in this environment; second, there was no evidence to suggest that a less restrictive treatment setting would have been insufficient. Based upon the submitted records and accepted principles of psychiatric practice, the residential rehabilitation services at issue were not medically necessary for treatment of the patients behavioral health condition. The Health Insurers denial should be upheld.
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A 62-year-old male enrollee has requested authorization and coverage for proton beam therapy.
The Health Insurer has denied this request and reported that the requested service is
investigational for the treatment of the enrollees prostate cancer. | Upheld | Experimental | Summary Reviewer 1
A 62-year-old male enrollee has requested authorization and coverage for proton beam therapy.
The Health Insurer has denied this request and reported that the requested service is
investigational for the treatment of the enrollees prostate cancer. The physician reviewer found
that most current medical literature regarding the treatment of localized prostate cancer is on
the use of photon-based radiation treatment. The benefits of proton therapy in prostate cancer
treatment are still controversial due to a lack of high-level evidence showing its relative benefits
in improving patient quality of life, reducing treatment toxicity, and improving outcomes. Proton
therapy may potentially reduce the radiation dose to organs at risk and improve radiation dose
homogeneity. The risk of secondary malignancy is likely lower in patients with prostate cancer
treated with proton therapy compared to those treated with photon therapy. On the other hand,
disadvantages in using proton therapy include dose distribution and conformality and
uncertainties in the radiobiologic effectiveness in treating patients with prostate cancer. While
there are no randomized phase III trials comparing the toxicity profile and effectiveness of proton
therapy versus photon therapy in the treatment of prostate cancer, there are several published
prospective and retrospective studies with long-term follow-up data showing the safety and
efficacy of proton therapy in prostate cancer. In this clinical setting though, a combined modality
using brachytherapy and external beam radiation therapy (EBRT) is likely to provide the patient
with superior outcomes in terms of biochemical progression-free survival. Therefore, proton
beam therapy is not likely to be more beneficial for treatment of the patients condition than any
available standard therapy.
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A 47-year-old female enrollee has requested authorization and coverage for FreeStyle Libre continuous glucose monitor. The Health Insurer has denied this request indicating that the requested device is not medically necessary for treatment of the enrollees diabetes. | Overturned | Medical Necessity | Summary Reviewer
A 47-year-old female enrollee has requested authorization and coverage for FreeStyle Libre continuous glucose monitor. The Health Insurer has denied this request indicating that the requested device is not medically necessary for treatment of the enrollees diabetes. The physician reviewer found that according to the American Association of Clinical Endocrinologists and American College of Endocrinology consensus statement, real-time continuous glucose monitors should be available to all insulin-using patients regardless of diabetes type. Patients with type 2 diabetes who use antihyperglycemic agents other than insulin might also benefit from continuous glucose monitors, but the evidence base is inadequate to make a strong recommendation. The consensus statement noted the primary purpose of continuous glucose monitors is to identify glucose patterns, hypoglycemia, and hyperglycemia. Patients using personal continuous glucose monitors should use real-time data to prevent and/or treat hypoglycemia and hyperglycemic excursions, as well as retrospectively to adjust their treatment regimens. As this patient is currently using insulin, she meets these criteria. The medical evidence supports the requested device in this setting. Thus, the FreeStyle Libre continuous glucose monitor is medically necessary for the treatment of this patient. Therefore, the requested device is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned. | 1 |
This patient is a 44-year-old female who presented to her provider on 3/12/21. The records noted that is 5 feet 2 inches tall and weighed 165.7 pounds, resulting in a body mass index of 30.31 kg/m2. The patient has requested authorization and coverage for laparoscopy, surgical, gastric restrictive procedure, with gastric bypass and Roux-en-Y gastroenterostomy. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. | Upheld | Medical Necessity | Summary Reviewer
This patient is a 44-year-old female who presented to her provider on 3/12/21. The records noted that is 5 feet 2 inches tall and weighed 165.7 pounds, resulting in a body mass index of 30.31 kg/m2. The patient has requested authorization and coverage for laparoscopy, surgical, gastric restrictive procedure, with gastric bypass and Roux-en-Y gastroenterostomy. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested services. Although the patient may benefit from conversion to gastric bypass for treatment of severe refractory gastroesophageal reflux disease in the setting of a prior Lap-band with hiatal hernia and esophageal dysmotility, additional documentation is needed. The poor esophageal motility would make her a poor candidate for either a LINX or standard Nissen fundoplication. However, the patient should still undergo a comprehensive multidisciplinary evaluation for the subsequent dietary and lifestyle changes unique to gastric bypass regardless of the primary indication. Although a brief dietary note was provided with standard dietary handouts, the records do not document a behavioral evaluation. Therefore, a multidisciplinary evaluation has not been completed. Therefore, the requested laparoscopy, surgical, gastric restrictive procedure, with gastric bypass and Roux-en-Y gastroenterostomy is not medically necessary for the treatment of this patient.
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A 54-year-old male enrollee has requested reimbursement for radiofrequency neurolysis performed on 4/08/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition.
In this case, the records indicate that this patient underwent radiofrequency ablation in March 2015 prior to the repeat radiofrequency ablation on 4/08/16. The patient previously experienced several months of pain reduction following the radiofrequency ablation in March 2015. | Overturned | Experimental | Summary Reviewer 3
A 54-year-old male enrollee has requested reimbursement for radiofrequency neurolysis performed on 4/08/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition. The physician reviewer found there is sufficient support for a portion of the services at issue. In this case, the records indicate that this patient underwent radiofrequency ablation in March 2015 prior to the repeat radiofrequency ablation on 4/08/16. The patient previously experienced several months of pain reduction following the radiofrequency ablation in March 2015. Based on the medical evidence, the superior efficacy of radiofrequency ablation at the cervical C7 level has been established. However, there is a lack of support for radiofrequency ablation performed on thoracic levels T1, T2 and T3. Boswell and colleagues noted the evidence for pain relief with radiofrequency neurotomy of cervical and lumbar medial branch nerves is moderate for short- and long-term pain relief, and indeterminate for thoracic facet neurotomy. Manchikanti and colleagues noted the evidence for therapeutic thoracic facet joint nerve blocks is fair, limited for radiofrequency neurotomy, and not available for thoracic intraarticular injections. In sum, radiofrequency neurolysis at the C7 level performed on 4/08/16 was likely to have been more efficacious than other treatment options. However, the superior efficacy of radiofrequency neurolysis performed on thoracic levels T1, T2 and T3 has not been established. Based upon the information set forth above, a portion of the services at issue was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be partially overturned.
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A 55-year-old male enrollee has requested reimbursement for CPT code 81479 provided on 12/21/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 3
A 55-year-old male enrollee has requested reimbursement for CPT code 81479 provided on 12/21/18. 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 once prostate cancer is diagnosed in a pathologic specimen, risk stratification is performed by the analysis of certain features, such as the grade of tumor and prostate-specific antigen level. This helps guide the most appropriate therapy for patients, taking into account their age and comorbidities, because many patients will not require therapy (i.e. surgery or radiation) and may be followed closely instead. The important features to recognize are Gleason score and prostate-specific antigen level, but these are imperfect. Thus, current biomarkers are inadequate for risk stratification, and better prognostic biomarkers are needed. The Oncotype DX is a gene expression analysis of target genes in the biopsy specimen that generates a genomic prostate score (GPS). The GPS may help identify patients with very low risk disease that can be followed rather than referred for surgery. The medical evidence supports the services at issue in this clinical setting. Thus, CPT code 81479 provided on 12/21/18 was likely to have been more beneficial than other methods of evaluating this patient.
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A 50-year-old female enrollee has requested reimbursement and prospective authorization and coverage for laser treatment (CPT 96920) provided from 1/4/16 and 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 vitiligo. | Overturned | Medical Necessity | Summary Reviewer
A 50-year-old female enrollee has requested reimbursement and prospective authorization and coverage for laser treatment (CPT 96920) provided from 1/4/16 and 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 vitiligo. The physician reviewer found the laser treatment (CPT 96920) provided from 1/4/16 and forward was and is medically necessary for treatment of the patients medical condition. According to Nicolaidou and colleagues Vitiligo is a common and chronic disease with a great impact on patients quality of life. Phototherapy with narrowband ultraviolet B radiation and excimer laser are two treatment modalities that are used increasingly for the management of the disease with variable results. Treatment with the excimer is the standard of care in this clinical setting and is supported as a first-line treatment for vitiligo (Grimes). Based on the support in the peer-reviewed literature, the services at issue have been established as medically necessary for treatment of the patients vitiligo. Therefore, the services at issue were and are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 56-year-old male enrollee has requested authorization and coverage for proton treatment. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees tumor of the hypopharynx. | Upheld | Experimental | Summary Reviewer 2
A 56-year-old male enrollee has requested authorization and coverage for proton treatment. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees tumor of the hypopharynx. The physician reviewer found Currently, that there is a lack of clinical data in the medical literature to indicate the superior efficacy of the requested services when compared to conventional treatment options. In the majority of cases, the standard approach to treat this malignancy is with standard photon techniques using intensity modulated radiation therapy (IMRT). A recent comparative analysis by Sio and colleagues found no significant difference in symptom burden in the acute and chronic phases of treatment with proton therapy compared to photon therapy for head and neck cancer. Also, the ASTRO emerging technology committee report on proton therapy specifically states that there is insufficient data to recommend proton beam therapy for routine head and neck radiation therapy outside of clinical trials, (Allen, et al). Moreover, there is a lack of level I evidence to support the use of proton therapy for the treatment of head and neck cancer. The patients previous history of treatment with radioactive iodine does not preclude the use of standard treatment with photons. Therefore, proton therapy is not likely to be more effective than standard therapy in the treatment of this patients medical condition. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 36-year-old female enrollee has requested reimbursement for reduction mammoplasty performed on 7/28/16. The Health Insurer has denied this request indicating that the surgery at issue was not medically necessary for treatment of the enrollees macromastia.
that according to the patients letter, her complaints included neck, shoulder and back pain due to her large breasts. | Upheld | Medical Necessity | Summary Reviewer
A 36-year-old female enrollee has requested reimbursement for reduction mammoplasty performed on 7/28/16. The Health Insurer has denied this request indicating that the surgery at issue was not medically necessary for treatment of the enrollees macromastia. The physician reviewer found that according to the patients letter, her complaints included neck, shoulder and back pain due to her large breasts. These are the typical complaints of women with macromastia. However, this patients records do not support the medical necessity of reduction mammoplasty. There were no photographs provided for review and the records do not include any supporting documentation from the patients primary care provider that confirms the presence of disabling musculoskeletal symptoms from macromastia. An operative or pathology report documenting the weight of the reduction was also not provided. A work-up for other possible causes of her symptoms is not documented, and she has not reportedly been evaluated by a musculoskeletal specialist. The records do not include any documentation that attempts at medical treatment for chronic musculoskeletal pain such as chiropractic care, physical therapy, analgesics or support bras. In this case, only the plastic surgeons notes describe musculoskeletal pain. Confirmatory evidence of symptoms, such as a history of conservative therapy, photographic evidence of severe breast hypertrophy or a history of frequent primary care physician visits for musculoskeletal symptoms is necessary to support the history provided by the plastic surgeon. All told, the reduction mammoplasty performed on 7/28/16 was not medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the surgery at issue was not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
A 41-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 11/06/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. | Overturned | Medical Necessity | Summary Reviewer 1
A 41-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 11/06/15. 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. Per Skaane and colleagues, the use of mammography plus tomosynthesis in a screening environment resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers. Ciatto and colleagues noted that integrated two-dimensional and three-dimensional mammography improves breast cancer detection and has the potential to reduce false positive recalls. All told, breast tomosynthesis performed on 11/06/15 was likely to have been more efficacious than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 38-year-old male enrollee has requested reimbursement for the homocysteine testing provided on 9/5/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees anemia. | Overturned | Experimental | Summary Reviewer 2
A 38-year-old male enrollee has requested reimbursement for the homocysteine testing provided on 9/5/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees anemia. The physician reviewer found that in the case under discussion, the patient was being evaluated for anemia. Part of the differential is nutritional deficiency in folate or vitamin B12. Discriminating between these two deficiencies is possible by analyzing homocysteine and methylmalonic acid levels. Homocysteine levels are elevated in folate deficiency since methyl-tetrahydrofolate is a methyl donor to cobalamin. In contrast, folate is not required for the conversion of methylmalonyl-CoA to succinyl-CoA where S-adenosylcobalamin is the cofactor (Allen, et al; Tefferi). Given these findings, the homocysteine testing provided on 9/5/14 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, I have determined the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 25-year-old transgender male enrollee has requested authorization and coverage for total hysterectomy. 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.
he needs to be living as male for two years and on hormones for one year before surgery. | Overturned | Medical Necessity | Summary Reviewer
A 25-year-old transgender male enrollee has requested authorization and coverage for total hysterectomy. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the medical necessity of the requested services. The Health Insurer noted that the requested services are not medically necessary because he needs to be living as male for two years and on hormones for one year before surgery. World Professional Association for Transgender Health (WPATH) has no requirements for social transition before hysterectomy. There is a one year requirement before reconstructive genital surgery, such as phalloplasty or metoidioplasty, but not for hysterectomy. Per WPATH, social transition is not required before hysterectomy. WPATH recommends one year of hormones before hysterectomy, unless this is not clinically indicated. The decision that this is clinically indicated before one year lies with the patients treatment team, which recommends the surgery. WPATH lists 12 continuous months of hormone therapy as appropriate to the patients gender goals (unless hormones are not clinically indicated for the individual). This provides flexibility for the treatment team to decide on the appropriate hormone treatment regimen before hysterectomy. WPATH noted that hysterectomy is one of the medically necessary treatments for gender dysphoria. There is sufficient support for the requested services in this clinical setting. Therefore, the requested hysterectomy is medically necessary for the treatment of this patient. | 1 |
A 24-year-old female enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus. | Overturned | Medical Necessity | Summary Reviewer
A 24-year-old female enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus. The physician reviewer found in managing patients with chronic HCV denying treatment because the patient does not have an advanced stage disease is not supported by the peer-reviewed literature. According to the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) Successful hepatitis C treatment results in sustained virologic response (SVR), which is tantamount to virologic cure, and as such, is expected to benefit nearly all chronically infected persons. Evidence clearly supports treatment in all HCV-infected persons, except those with limited life expectancy (less than 12 months) due to non-liver-related comorbid conditions. Moreover, post hoc analysis has revealed that non-cirrhotic HCV genotype 1 patients who are treatment naive and have less than 6,000,000 IU/mL viral load can be treated with an eight week course of Harvoni, instead of 12 weeks and achieve similar cure rates. Therefore, Harvoni should be approved as medically necessary based on national guidelines. 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 59-year-old female enrollee has requested reimbursement for a cooling or combined cooling/heating device. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 1
A 59-year-old female enrollee has requested reimbursement for a cooling or combined cooling/heating device. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees medical condition. The physician reviewer found the use of continuous flow cryotherapy for reduction of postoperative swelling and pain has become commonplace in knee and shoulder surgery. However, prolonged exposure to extreme cold may induce an injury identical to that of frostbite. Therefore, continuous flow cryotherapy is not recommended for ankle and foot surgery. Complications related to cryotherapy are rare but can be devastating. They include chronic pain, frostbite, and loss of digits. Cold packs are effective and are generally recommended after foot and ankle surgery. Based upon a review of the literature, the device at issue was not likely to have been superior over other treatment options. Based upon the information set forth above, the device at issue was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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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. | Overturned | Experimental | Summary Reviewer 2
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 Groheux and colleagues reported that when a recurrence is depicted or a patient is suspected of having a recurrence by using conventional imaging, PET/CT is useful to determine whether this recurrence is isolated or not, and such a determination may have a potential effect on the patients treatment. Manohar and colleagues found that PET/CT is a very sensitive and specific imaging tool in detecting and restaging recurrent breast carcinoma. It can be a very useful imaging tool for restaging locoregional recurrences, and as a one-stop shop imaging technique to confirm suspicious metastatic disease on conventional imaging and to define the total burden of disease. Thus, there is support in the literature for the use of PET/CT to follow-up this patients left internal mammary lymph nodes, suspicious for having breast carcinoma metastases. 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.
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A 47-year-old male enrollee has requested authorization and coverage for vestibular stenosis repair. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollee, who has a history of nasal congestion and obstruction. The physician reviewer found that the patient had obstruction of nasal breathing. He underwent previous nasal surgery to restore nasal breathing which included valve repair. Based on the records, it was unclear if the previous surgery was on the internal or external nasal valve. | Upheld | Experimental | Summary Reviewer 1
A 47-year-old male enrollee has requested authorization and coverage for vestibular stenosis repair. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollee, who has a history of nasal congestion and obstruction. The physician reviewer found that the patient had obstruction of nasal breathing. He underwent previous nasal surgery to restore nasal breathing which included valve repair. Based on the records, it was unclear if the previous surgery was on the internal or external nasal valve. The internal nasal valve is the narrowest area of the nose where turbulence of the inspiratory and expiratory current takes place. Internal valve collapse can lead to nasal obstruction. It is characterized by the collapse during inspiration of the upper lateral cartilages; a narrowing of the angle between the dorsal septum and upper laterals can also contribute, but to a lesser extent. Functional rhinoplasty procedures for internal nasal valve have evolved over the past decade. Placement of precise cartilage grafts have been demonstrated to provide support which improves nasal breathing. The external nasal valve is formed by the columella, the nasal floor, and the nasal rim (or caudal border of the lower lateral cartilage). Cartilage grafting can also support the external valve. Absorbable implants for lateral cartilage support in patients with nasal valve collapse have been developed. There are limited studies supporting the use of these implants. At this time, the requested vestibular stenosis repair is not likely to be superior over other treatment options. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 45-year-old male enrollee has requested reimbursement for inpatient admission at a non-participating facility from 11/13/16 through 11/14/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees acute appendicitis.
In this patients case, he was admitted in stable condition and could have been treated at an observational level of care. He had a laparoscopic appendectomy without any complications. | Upheld | Medical Necessity | Summary Reviewer
A 45-year-old male enrollee has requested reimbursement for inpatient admission at a non-participating facility from 11/13/16 through 11/14/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees acute appendicitis. The physician reviewer found that the inpatient admission was not medically necessary for this patient. Inpatient care is necessary when the patients 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. Outpatient observation admission is appropriate when the physician is unsure about the patients need for inpatient admission and requires time for short term treatment, assessment, and reassessment in order to make that decision or the physician anticipates that the patients condition can be evaluated/treated within 24 hours and/or rapid improvement of the patients condition can be anticipated within 24 hours. In this patients case, he was admitted in stable condition and could have been treated at an observational level of care. He had a laparoscopic appendectomy without any complications. This procedure does not have to be performed on an inpatient only basis. Pain control was adequate after the surgery, and the patient tolerated an oral diet. The submitted documentation demonstrates that this patient could have been treated at a lower level of care. As such, admission at a non-participating facility from 11/13/16 through 11/14/16 were not medically necessary for treatment of the patients medical condition.
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.
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A 52-year-old female enrollee has requested authorization and coverage for a PET scan. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the evaluation of the enrollees medical condition. | Upheld | Medical Necessity | Summary Reviewer
A 52-year-old female enrollee has requested authorization and coverage for a PET scan. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that the National Comprehensive Cancer Network (NCCN) guidelines recommend conventional imaging of the chest, abdomen and pelvis using computed tomography (CT) as well as a radionuclide bone scan every two to six months for patients with recurrent breast cancer to the chest wall and solid organs as surveillance. PET/CT is usually is done when there are equivocal or suspicious findings suggestive of metastatic disease. The physiologic nature of a PET scan is used to confirm or exclude likely tumor recurrence. Piva and colleagues noted that PET/CT imaging can be useful when there are equivocal findings on conventional imaging. In this patients case, the medical necessity of PET/CT every three months has not been established since there has been no evidence of distant metastases in the past, and there are no conventional imaging reports after recent surgical and radiation treatment to suggest equivocal or suspicious findings. Therefore, the requested PET scan is not medically necessary for the evaluation of this patient. | 0 |
A 34-year-old male has requested authorization and coverage for multileaf collimator device. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.T | Upheld | Experimental | Summary Reviewer 1
A 34-year-old male has requested authorization and coverage for multileaf collimator device. 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 in general, IMRT is not an experimental technique, but rather a radiation planning and delivery tool available to the radiation oncologist to better shape the radiation dose distribution, and therefore minimize the dose to normal structures. IMRT is a tool that clinicians can use when there is concern about sparing normal tissues from high dose exposure. There are emerging data for the use of IMRT for Hodgkins lymphoma. The rationale to use IMRT includes relative sparing of the lungs, heart, salivary glands, and other tissues. In select patients, IMRT may significantly reduce the dose to these structures. However, 77338 is billed for the treatment planning and not the treatment delivery, and it is billed once per plan. Thus, the superior efficacy of the requested 45 units of 77338 has not been established. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The patient is a 58-year-old man with type 2 diabetes. The patient has requested authorization and coverage for Ozempic 2 mg/1.5 mL pen injectors. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 58-year-old man with type 2 diabetes. The patient has requested authorization and coverage for Ozempic 2 mg/1.5 mL pen injectors. 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 Ozempic is a member of the glucagon-like peptide 1 (GLP-1) analogs, a new class of drugs used in the treatment of type 2 diabetes that mimic the endogenous hormone GLP-1. This class of medications has shown significant improvements in glycemic control, progressive weight loss, low incidence of hypoglycemia and potential improvement of cardiovascular risk factors. Additionally, recent studies have demonstrated a significantly lower rate of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke among patients receiving Ozempic. Based on the submitted records, this patient is an excellent candidate for Ozempic. Therefore, Ozempic 2 mg/1.5 mL pen injectors are medically necessary for the treatment of this patient. | 1 |
The parent of a 15-year-old male enrollee has requested reimbursement for mental health residential services provided from 1/10/18 through 4/20/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions.
. On 12/29/17, the documentation noted that the patient had purchased knives and a taser gun. However, these records are from admission. The records for | Upheld | Medical Necessity | Summary Reviewer
The parent of a 15-year-old male enrollee has requested reimbursement for mental health residential services provided from 1/10/18 through 4/20/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found that the American Academy of Child and Adolescent Psychiatry and the American Association of Community Psychiatrists Child and Adolescent Level of Care Utilization System (CALOCUS) provides a reliable framework for determining the appropriate level of care for adolescents needing mental health treatment. In terms of risk of harm, the records support a score of 2. On 12/29/17, the documentation noted that the patient had purchased knives and a taser gun. However, these records are from admission. The records for the disputed timeframe indicated evidence of low risk of harm. Additionally, this note had minimal objective evidence. This record does not document that violent acts or self-harm were committed. In terms of functional status, the records support a score of 2. The patient has demonstrated episodic failure to achieve expected levels of functioning in relationships with family and peers. With regards to comorbidity, the records support a score of 1. The patient did not have active medical problems or active substance use issues. In terms of level of stress of the recovery environment, the records support a score of 2. There is no indication of an unsafe home environment. With regards to level of support of the recovery environment, the records support a score of 2. The patients family was actively involved in treatment on a regular basis. In terms of resiliency and treatment history, the records support a score of 3. It appears that the patients major depression symptoms were under good control with minimal signs or symptoms. He continued to have oppositional behaviors. With regards to acceptance and engagement of the patient, the records support a score of 2. The patient was able to establish positive relationships with clinicians despite oppositional behaviors. In terms of acceptance and engagement of the parents, the records support a score of 2. The parents worked actively and constructively with clinicians on a regular basis. Thus, the patient has a composite score of 16. This score correlates with intensive outpatient services. Therefore, mental health residential services provided from 1/10/18 through 4/20/18 were not medically necessary for the treatment of this patient. | 1 |
A 46-year-old female insured has requested authorization and coverage for lymphedema surgery
and two inpatient bed days. The Health Insurer has denied this request indicating that the requested
services are considered investigational for treatment of the insureds lymphedema. | Overturned | Experimental | Summary Reviewer 1
A 46-year-old female insured has requested authorization and coverage for lymphedema surgery
and two inpatient bed days. The Health Insurer has denied this request indicating that the requested
services are considered investigational for treatment of the insureds lymphedema.
The physician reviewer found that Garza and colleagues noted that, Lymphaticovenular
anastomosis (LVA) or lymphovenous bypass is a surgical procedure where lymphatic vessels in a
lymphedematous limb are connected to nearby small veins and venules using microsurgical and
super-microsurgical techniques. The authors found that Numerous studies have been published
which show improved symptoms and as much as 61% reduction in volume difference of the
affected limb after LVA at one year. In addition, Pereira and colleagues reported that LVA is an
effective treatment option to reduce the volume in the affected limb and to improve associated
symptoms. Moreover, Cheng and colleagues concluded that LVA was performed and the patients
remained in an inpatient setting for up to three days to allow for an adequate stabilization of the
anastomosis before being discharged. Overall, LVA is an established microsurgical technique for
the treatment of patients with lymphedema. LVA can be employed as a second stage after
liposuction removal of thick lymphedematous tissue for debulking or as an inpatient surgical
procedure to allow for careful observation, positioning, and mobilization after the procedure.
Therefore, the requested lymphedema surgery and two inpatient bed days is likely to be more
beneficial for treatment of the patients medical condition than any available standard therapy.
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A 66-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 5/17/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. | Upheld | Experimental | Summary Reviewer 2
A 66-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 5/17/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that this patient has an early stage melanoma. Commercially available gene expression profiling (GEP) tests are marketed as being able to classify cutaneous melanoma into separate categories
based on risk of metastasis. However, it remains unclear whether these tests provide clinically actionable prognostic information when used in addition to or in comparison with known clinicopathologic factors or multivariable nomograms that incorporate patient sex, age, tumor location and thickness, ulceration, mitotic rate, lymphovascular invasion, microsatellites, and sentinel lymph node biopsy status. Furthermore, the impact of these tests on treatment outcomes or follow-up schedules has not been established. Newer prognostic molecular techniques should not replace standard staging procedures. In addition, there is a lack of definitive data regarding its use for risk classification in patients with cutaneous melanoma, 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. Therefore, DecisionDx-Melanoma testing performed on 5/17/19 was not likely to have been more beneficial than other available standard therapy.
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The patient is a 65-year-old male who was diagnosed in March 2015 with prostate cancer. At that time, he was found to have bone metastases. He was initially treated with radiation therapy, androgen deprivation therapy, and docetaxel, then enzalutamide. With progression, he was treated with cabazitaxel, but there was no response with this therapy. The provider had recommended cabozantinib for treatment. The patient has requested authorization and coverage for Cabometyx (cabozantinib) 60 mg #30/30. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of this patients medical condition. | Upheld | Experimental | Summary Reviewer 3
The patient is a 65-year-old male who was diagnosed in March 2015 with prostate cancer. At that time, he was found to have bone metastases. He was initially treated with radiation therapy, androgen deprivation therapy, and docetaxel, then enzalutamide. With progression, he was treated with cabazitaxel, but there was no response with this therapy. The provider had recommended cabozantinib for treatment. The patient has requested authorization and coverage for Cabometyx (cabozantinib) 60 mg #30/30. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of this patients medical condition. Cabozantinib is a tyrosine kinase inhibitor that has been approved for use in renal cell carcinoma but not prostate cancer. This therapy with cabozantinib is not within National Cancer Comprehensive Network guidelines for treatment of prostate cancer. This patients provider proposed using it in this patient based on some very early phase studies in prostate cancer as well as a theoretical belief that it might be useful in those patients with a MET mutation, which this patient has. However, there is limited data that confirms clinical benefit in the use of this therapy for patients who are diagnosed with prostate cancer. The provider had also noted the lack of clinical benefit from these early studies. Furthermore, the presence of the MET mutation is not an indication that there is a reasonable likelihood of response to cabozantinib. Accordingly, at this time, cabozantinib is not likely to be of greater clinical benefit for the treatment of this patient than any other standard form of 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 55-year-old male enrollee has requested authorization and coverage for heart surgery (93580, percutaneous transcatheter closure of heart defect). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees patent foramen ovale. | Upheld | Experimental | Summary Reviewer 3
A 55-year-old male enrollee has requested authorization and coverage for heart surgery (93580, percutaneous transcatheter closure of heart defect). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees patent foramen ovale. The physician reviewer found that the use of device closure of patent foramen ovale for prevention of cryptogenic stroke has been the subject of much research study over a long period. Current guidelines from 2014 do not recommend patent foramen ovale closure. New studies suggest that there may be a change in guidelines, but a change has not yet taken place. Of note is that some studies emphasize high-risk patent foramen ovale which involves a larger shunt, size over 2 mm, atrial septal aneurysm or mobile septal motion, none of which was documented in this patients case. Thus, heart surgery (93580, percutaneous transcatheter closure of heart defect) is not likely to be of greater benefit than other treatment options. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 68-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 12/06/17. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 2
A 68-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 12/06/17. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that the prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index has also been thought to add a bit to these statistics. DecisionDx-Melanoma testing is an assay of 31 genes in an individuals melanoma cells. It then classifies that melanoma based on the five-year risk of metastasis. Gerami and colleagues reported on 217 cases, with good correlation between prognosis and DecisionDx-Melanoma classification, in patients undergoing sentinel node biopsy. However, it is not clear how the five-year DecisionDx-Melanoma data compares to the 10-year Balch data. Furthermore, it is not clear if the DecisionDx-Melanoma assay classification can be used to make clinical decisions. In sum, DecisionDx-Melanoma testing performed on 12/06/17 was not likely to have been more efficacious than other methods of evaluating this patient.
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A 55-year-old female enrollee has requested authorization and coverage for Viekira Pak. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus. | Overturned | Medical Necessity | Summary Reviewer
A 55-year-old female enrollee has requested authorization and coverage for Viekira Pak. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus. The physician reviewer found the review of the submitted documentation and relevant literature demonstrates the medical necessity of the requested medication. According to the American Association for the Study of Liver Diseases (AASLD) recommendations for treating hepatitis C, Successful hepatitis C treatment results in sustained virologic response (SVR), which is tantamount to virologic cure, and as such, is expected to benefit nearly all chronically infected persons. Denying treatment for patients with early stage hepatitis C is not supported by the peer-reviewed literature. Thus, the recommendation is not deny patients treatment if they have early stage disease, but to provide treatment to avoid complications from advanced disease, including liver failure and extrahepatic complications. In addition, the AASLD/IDSA guidelines state that high priority for treatment owing to high risk for complications include patients with fibrosis (Metavir F2). This patient has a Metavir score of F2. Furthermore, AASLD/IDSA guidelines recommend Viekira Pak, a daily fixed-dose combination of paritaprevir (150 mg)/ritonavir (100 mg)/ombitasvir (25 mg) plus twice-daily dosed dasabuvir (250 mg) for 12 weeks for patients with hepatitis C genotype 1 in whom prior treatment with peg-interferon and ribavirin has failed. 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 48-year-old female enrollee has requested reimbursement for a breast tomosynthesis that was performed on 11/25/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for purposes of the enrollees breast cancer screening. | Overturned | Experimental | Summary Reviewer 1
A 48-year-old female enrollee has requested reimbursement for a breast tomosynthesis that was performed on 11/25/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for purposes of the enrollees breast cancer screening. The physician reviewer found medical studies have shown that the addition of three dimensional (3D) digital breast tomosynthesis (DBT) reduces false positives and increases cancer detection when compared to two dimensional full field digital mammography (FFDM, 2D) alone. Recall rates are reduced by 15-17%: 3D allows for separation of structures to differentiate architectural distortion from masses and overlapping fibroglandular tissue (asymmetries). Studies have also shown that there has been an increase in cancer detection by 33-53%: cancer detection increased from 6 cancers/1000 women screened with 2D to 8 cancers/1000 women screened with 3D. Three dimensional DBT allows better characterization of possible masses, spiculation, and architectural distortion. In sum, there is sufficient evidence supporting the use of tomosynthesis for routine breast cancer screening. Thus, the breast tomosynthesis performed on 11/25/15 was likely to be more beneficial for this patient than any available standard modalities. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 42-year-old female enrollee has requested authorization and coverage for total disc replacement. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.
that this patient presents with progressively worsening neck pain that radiates into the right shoulder with right upper extremity pain and numbness. Her pain affects activities of daily living. Clinical examination findings have documented motor loss and apparent reflex changes generally consistent with imaging evidence of C4-5 and C5-6 disc pathology. She is status post prior anterior cervical discectomy and fusion at the C6-7 level. | Upheld | Experimental | Summary Reviewer 1
A 42-year-old female enrollee has requested authorization and coverage for total disc replacement. 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 progressively worsening neck pain that radiates into the right shoulder with right upper extremity pain and numbness. Her pain affects activities of daily living. Clinical examination findings have documented motor loss and apparent reflex changes generally consistent with imaging evidence of C4-5 and C5-6 disc pathology. She is status post prior anterior cervical discectomy and fusion at the C6-7 level. Detailed evidence of a recent, reasonable and/or comprehensive non-operative treatment protocol trial and failure has been submitted. Under consideration is a request for total disc replacement at the C4-5 and C5-6 levels adjacent to the C6-7 fusion. Although there is literature support for two-level cervical artificial disc replacement, this surgical request for a two-level artificial disc replacement adjacent to a prior cervical fusion would constitute a hybrid construct for which there is a lack of large volume, long-term peer-reviewed outcome studies. The peer-reviewed literature by Rajakumar and colleagues submitted by the provider in support of this hybrid surgery request also concludes that more data from larger numbers of patients with long-term follow-up is required to confirm the safety and efficacy of this type of hybrid construct. Therefore, the requested total disc replacement is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.
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The parent of a 13-year-old male enrollee has requested authorization and coverage for growth hormone therapy (Humatrope). The Health Plan has denied this request indicating that the requested therapy is not medically necessary for the treatment of the enrollees medical condition.
This patient has been treated with growth hormone therapy, and has apparently had a very good response in terms of increased height velocity. | Upheld | Medical Necessity | Summary Reviewer
The parent of a 13-year-old male enrollee has requested authorization and coverage for growth hormone therapy (Humatrope). The Health Plan has denied this request indicating that the requested therapy is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the requested therapy. This patient has been treated with growth hormone therapy, and has apparently had a very good response in terms of increased height velocity. Based on the medical records, this patients height velocity is consistent with simple constitutional delay. As to the diagnosis of idiopathic short stature, he does not have absolute height standard deviation score more than 2.25 standard deviations below normal for age. In terms of mid-parental height, the records indicate that he was 1.96 standard deviations below mid-parental height. This patients bone age is not delayed. Importantly, constitutional delay need not be treated with growth hormone supplementation. There is a lack of support for the requested therapy in this clinical setting. All told, the requested growth hormone therapy (Humatrope) is not medically indicated in this clinical setting. Therefore, the requested therapy is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 65-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees chronic hepatitis C virus genotype 1a. | Overturned | Medical Necessity | Summary Reviewer
A 65-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees chronic hepatitis C virus genotype 1a. The physician reviewer found according to joint guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), all patients with chronic hepatitis C should be treated except those with life expectancy less than 12 months due to non-liver-related conditions. This applies regardless of fibrosis stage or viral load. Per guidelines, treatment naive genotype 1 patients should be treated with Harvoni for 12 weeks. These guideline recommendations are based on multiple randomized clinical trials, and the medication is U.S. Food and Drug Administration (FDA) approved for all patients with chronic genotype 1 hepatitis C regardless of fibrosis stage (Kowdley, et al; Afdhal, et al). For these reasons, the requested treatment with Harvoni is supported as medically necessary for the treatment of this patients hepatitis C infection. In conclusion, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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, the patient has evidence of a functional impairment related to her abnormal upper eyelid positions, related to significant eyelid ptosis.
In this case, the patient presented with functional impairment related to her vision secondary to eyelid malposition in the form of ptosis. Her surgical procedure was consistent with correction and postoperatively she was noted to have improved vision. | Overturned | Medical Necessity | Summary Reviewer
The physician reviewer found to the documentation submitted for review, the patient has evidence of a functional impairment related to her abnormal upper eyelid positions, related to significant eyelid ptosis. This is supported by physical examination, review of the photographs and functional improvement following her surgery. According to Zoumalan and Roostaeian Excess upper lid skin is the most common complaint a patient will describe with regard to the aging upper eyelid. Loss of elasticity results in increased skin folding over the lid crease. This is seen clinically as lash hooding where the skin overhangs and conceals the lid crease and, in severe cases, can even obstruct the visual field. Excess eyelid skin can obstruct the visual field and thus considered a functional problem. In this case, the patient presented with functional impairment related to her vision secondary to eyelid malposition in the form of ptosis. Her surgical procedure was consistent with correction and postoperatively she was noted to have improved vision. Therefore, the blepharoplasty performed on 6/3/16 was consistent with a medically necessary procedure. Therefore, the procedure at issue was medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned. | 1 |
The patient is a 51-year-old female with a history of osteoporosis. The patient has requested
authorization and coverage for Evenity (romosozumab-aqqg) injection 105 mg/1.17 mL. The
Health Insurer has denied this request and reported that the requested medication is not
medically necessary for the treatment of this patient. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 51-year-old female with a history of osteoporosis. The patient has requested
authorization and coverage for Evenity (romosozumab-aqqg) injection 105 mg/1.17 mL. The
Health Insurer has denied this request and reported that the requested medication is not
medically necessary for the treatment of this patient. The physician reviewer found that the
submitted documentation supports the medical necessity of a portion of the requested
medication. Khosla and Hofbauer explain, Osteoporosis is an enormous and growing public
health problem. Once considered an inevitable consequence of ageing, it is now eminently
preventable and treatable. Cremers and colleagues report that bisphosphonates have been the
standard therapy for osteoporosis. Regarding recent progresses in the treatment of osteoporosis,
Li and colleagues note that in patients with high or very high risk for fracture, sequential or
combined therapies may be considered with the initial drugs being anabolic agents such as
teriparatide and romosozumab. The U.S. Food and Drug Administration (FDA) approves the use
of Evenity (generic name romosozumab) for the treatment of osteoporosis. Evenity is a strong
anabolic medication, in contrast to the bisphosphonates, which have anti-resorptive effects. In a
study of postmenopausal women with osteoporosis who were at high risk for fracture, Saag and
colleagues report that treatment with Evenity for 12 months followed by alendronate resulted in
a significantly lower risk of fracture than alendronate alone. McClung notes that beginning
treatment with an anabolic agent, such as Evenity, in patients at very high or imminent risk of
fracture an effective and appropriate treatment plan. Therefore, Evenity (romosozumab-aqqg)
injection 105 mg/1.17 mL for 12 months is medically necessary for the treatment of this patient.
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A 59-year-old male enrollee has requested reimbursement for platelet-rich plasma injections provided from 7/14/17 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. | Upheld | Experimental | Summary Reviewer 2
A 59-year-old male enrollee has requested reimbursement for platelet-rich plasma injections provided from 7/14/17 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 that there is current evidence-based medical guideline and literature support for the treatment of significantly symptomatic osteoarthritis of the knee when specific criteria have been met, including failed conservative treatment (including intraarticular steroids), osteoarthritis that was not advanced, and age under 50 years. Repeat platelet-rich plasma injections are only supported once a year if previous injection provided significant relief for over six months. There is a lack of large volume, long-term peer-reviewed outcome studies to support the use of platelet-rich plasma in the treatment of sacroiliac joint pain and wrist/hand disorders. In this case, there is no documentation as to the severity of the reported osteoarthritis of the patients right knee, details of prior conservative treatment failure, and rationale for exception to recommended age limits. There is no compelling rationale presented to support the necessity of platelet-rich plasma injections for the sacroiliac joint or bilateral hands/thumbs in the absence of evidence-based medical literature support. Therefore, platelet-rich plasma injections provided from 7/14/17 forward were not and are not likely to be of greater benefit than other available treatment options. 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 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. | Upheld | Experimental | Summary Reviewer 3
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 Intra-articular steroid injection is a traditional approach to treating sacroiliac joint pain. For long-term pain relief, however, lesioning the sacral lateral branches may be a better approach. In a randomized, prospective study by Dutta and colleagues comparing the efficacy of intra-articular depo-methylprednisolone injection to that of pulsed radiofrequency ablation for sacroiliac joint pain, the radiofrequency ablation group demonstrated superior pain relief over the steroid injection group at 3-month and 6-month post-procedures. In addition, a recently completed multidisciplinary, multi-society effort to develop appropriate use criteria for sacroiliac interventions concluded that lateral branch radiofrequency neurotomy/radiofrequency ablation is an appropriate treatment for appropriately selected patients. There is sufficient support for the requested services in this clinical setting. Therefore, the requested radiofrequency ablation is likely to be more beneficial for treatment of the patient than any available standard therapy.
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The patient is a 40-year-old female with a myriad of medical comorbidities, including Ehlers-Danlos connective tissue disease. She was evaluated as a second opinion on 3/26/21 due to concern regarding a suspected tethered cord.
This patient has a reported normal neurological examination by both neurology and her neurological surgeon. MRI scan of the lumbar spine is normal. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 40-year-old female with a myriad of medical comorbidities, including Ehlers-Danlos connective tissue disease. She was evaluated as a second opinion on 3/26/21 due to concern regarding a suspected tethered cord. The physician reviewer found that the entity of occult tethered cord syndrome is controversial in the neurosurgery field. The patientas surgeon admits as much in his documentation. A number of publications are available in this area. The provideras review provides a thorough assessment of this knowledge in the field. In the provideras review, the only randomized controlled study was conducted as a pilot by Steinbok and colleagues in 2016. These investigators compared surgical (filum sectioning) and medical management of patients with urologic symptoms refractory to conservative treatments. All had normal conus positions and abnormal urodynamics. Only 21 patients could be accrued after eight years of trying. No significant differences were found between the groups. Overall, the data are challenging to interpret on the basis of the retrospective nature of the reports, the variability of the studies, the very small sample sizes, and the fact that the only prospective randomized study yielded a negative result regarding surgery. Most of the studies involved children, and this patient is an adult. A reasonable number of the patients in the noted studies one could argue had findings that made their cases not aocculta. This patient has a reported normal neurological examination by both neurology and her neurological surgeon. MRI scan of the lumbar spine is normal. The urodynamic report has no interpretation, and there is no clear assessment by a urological specialist. There is no independent neurology assessment that indicates tethered cord as a consideration. The data in support of surgical intervention in the form of filum sectioning is weak at best, and the diagnosis of occult tethered cord syndrome remains controversial. There is a lack of support for the requested services in this clinical setting. Therefore, lumbar spine surgery and other related services (codes 63200, 13160 and 69990) and the associated inpatient bed day are not medically necessary for the treatment of this patient.
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A 64-year-old female enrollee has requested reimbursement for genetic testing performed on 11/30/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who was diagnosed with breast cancer. The physician reviewer found that this patient had biopsy proven DCIS with extensive microcalcifications indicated on MRI. | Overturned | Experimental | Summary Reviewer 1
A 64-year-old female enrollee has requested reimbursement for genetic testing performed on 11/30/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who was diagnosed with breast cancer. The physician reviewer found that this patient had biopsy proven DCIS with extensive microcalcifications indicated on MRI. OncotypeDX was used to determine the risk of invasion in order to determine surgical decision making regarding lumpectomy versus mastectomy. However, OncotypeDX DCIS was developed to determine the need for radiation post-lumpectomy and not for surgical decision making. In addition, data regarding utility are still preliminary. This patient had extensive calcifications and the standard of care would be to biopsy the calcifications to determine the extent of the disease and to determine whether or not to proceed with mastectomy versus breast conserving therapy. As such, this test was not used in the correct context and was not likely to be more beneficial than the standard of care of using clinical factors to choose the extent of therapy. Therefore, for the reasons stated above, the services at issue were not likely to have been 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 63-year-old male enrollee has requested reimbursement and prospective authorization and coverage for Avastin injections from 2/27/14 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for the treatment of the enrollees medical condition. | Upheld | Medical Necessity | Summary Reviewer
A 63-year-old male enrollee has requested reimbursement and prospective authorization and coverage for Avastin injections from 2/27/14 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found the current medical evidence does not support the services at issue in this clinical setting. The use of Avastin has been well studied as an adjunct to chemotherapy in pancreatic cancer. Kindler and colleagues reported a study of 602 patients with pancreatic cancer treated with either Gemzar or Gemzar with Avastin. The authors noted that the addition of Avastin did not improve survival in advanced pancreatic cancer patients. Van Cutsem and colleagues reported on 607 patients randomized to chemotherapy with or without Avastin. The authors reported that there was no significant difference in overall survival with the use of the Avastin. All told, Avastin injections from 2/27/14 forward were not and are 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.
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A 20-year-old male enrollee has requested reimbursement for the human T-lymphotropic virus (HTLV) testing performed on 4/25/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees sperm prior to banking. | Overturned | Experimental | Summary Reviewer 2
A 20-year-old male enrollee has requested reimbursement for the human T-lymphotropic virus (HTLV) testing performed on 4/25/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees sperm prior to banking. The physician reviewer found that the lab performing the sperm banking states testing for HTLV-I and HTLV-II are needed to meet requirements set forth by the U.S. Food and Drug Administration (FDA). Further, the FDA has issued guidelines for testing all donated blood for HTLV-I and HTLV-II. The FDA requirements indicate that HTLV testing is not investigational in this clinical setting. Moreover, sperm banking is considered standard of care for young men requiring chemotherapy. Accordingly, the HTLV testing performed on 4/25/16 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 testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 62-year-old female enrollee has requested reimbursement for the DecisionDx melanoma gene expression assay provided on 7/29/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees cutaneous melanoma. | Upheld | Experimental | Summary Reviewer 3
A 62-year-old female enrollee has requested reimbursement for the DecisionDx melanoma gene expression assay provided on 7/29/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that Melanoma staging is characterized by the American Joint Committee on Cancer (AJCC)) system that defines cutaneous melanoma stages 0-IV. While the majority of clinical stage I patients will be disease-free at five years, some stage I patients will develop advanced disease. As patients diagnosed with stage I or II melanoma are generally viewed as having a low risk of metastasis, treatment planning is limited to surgical excision of the primary tumor followed by routine skin examinations and clinical examination. In contrast, patients diagnosed with stage III melanoma receive complete lymph node dissection, active surveillance measures and often, referral to medical oncology for adjuvant medical therapy and clinical trial participation. DecisionDx melanoma assesses the expression of 31 genes that have been associated with metastasis and classifies tumors as Class 1 consistent with a low risk of metastasis or Class 2 suggestive of a high risk of metastasis. One peer-reviewed publication indicated that there was a statistically significant association of a Class 1 signature by DecisionDx melanoma assay for primary dermal melanoma (PDM), whereas cutaneous metastatic melanoma (CMM) were more frequently class 2 (Sidiropoulos, et al). The authors concluded that the melanoma prognostic assay may be a useful tool for distinguishing PDM from CMM. According to the results of analysis of this patients melanoma performed with DecisionDx melanoma assay, the tumor was classified as Class 2 with molecular signature associated with a high risk of near term (within five years) metastatic disease. Identification of the increased risk of recurrence of melanoma in this patient helped establishing an appropriate follow-up plan. Thus, the DecisionDx melanoma gene expression assay provided on 7/29/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 54-year-old male enrollee has requested authorization and coverage for Gilotrif (afatinib dimaleate tablet 40 mg). The Health Insurer indicates that the requested medication is investigational for the treatment of the enrollees medical condition. Therefore, the Health Insurer has denied coverage for the requested medication.
| Overturned | Experimental | Summary Reviewer 3
A 54-year-old male enrollee has requested authorization and coverage for Gilotrif (afatinib dimaleate tablet 40 mg). The Health Insurer indicates that the requested medication is investigational for the treatment of the enrollees medical condition. Therefore, the Health Insurer has denied coverage for the requested medication.
At issue is whether the requested medication is likely to be more beneficial for treatment of the enrollees condition than any available standard therapy. The physician reviewer found that Afatinib is an inhibitor of EGFR. This medication is of benefit in non-small cell lung cancers, particularly adenocarcinoma, wherein there exist certain mutations of the EGFR gene. Although such mutations are rare in squamous carcinoma, they do exist, and there has been some responsiveness in squamous cell cancer with specific mutations. However, there is no real data showing reliable benefit with afatinib in patients with the very rare mutations documented in this patient. Therefore, Gilotrif (afatinib dimaleate tablet 40 mg) is not likely to be more beneficial than other available standard therapy.
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A 53-year-old male enrollee has requested authorization and coverage for Inspire upper airway stimulation system. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 1
A 53-year-old male enrollee has requested authorization and coverage for Inspire upper airway stimulation system. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollees medical condition. The physician reviewer found obstructive sleep apnea is an increasingly prevalent clinical problem with significant effects on both personal and public health. CPAP has demonstrated excellent efficacy and low morbidity. Although traditional upper airway surgical procedures target the anatomic component of obstruction, upper airway stimulation tackles the twin goals of improving anatomic and neuromuscular pathology. There is sufficient support for the requested device in this clinical setting. In this patient who is status post multiple procedures for sleep apnea, and who cannot tolerate CPAP or an oral appliance, implantation with a hypoglossal nerve stimulator is appropriate. All told, the requested Inspire upper airway stimulation system is likely to be more effective than other treatment options. Based upon the information set forth above, the requested device is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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The patient is a 27-year-old female with a history of vitiligo affecting the facial skin. The patient has been treated with Xtrac (excimer) laser therapy. The patient has requested reimbursement for dermatology services provided from 6/10/15 through 7/29/15. The Health Insurer has denied this request as not medically necessary.
, the patient has been treated with Xtrac laser therapy for treatment of vitiligo affecting the facial skin. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 27-year-old female with a history of vitiligo affecting the facial skin. The patient has been treated with Xtrac (excimer) laser therapy. The patient has requested reimbursement for dermatology services provided from 6/10/15 through 7/29/15. The Health Insurer has denied this request as not medically necessary. Review of the submitted documentation and relevant literature demonstrates the medical necessity for the services at issue. According to the documentation submitted for review, the patient has been treated with Xtrac laser therapy for treatment of vitiligo affecting the facial skin. Vitiligo is an autoimmune disorder resulting in destruction of melanocytes, the pigment generating cells, in the skin. Use of the Xtrac (excimer) laser is a U.S. Food and Drug Administration (FDA) approved therapy for the treatment of vitiligo. In addition, treatment of vitiligo is not considered cosmetic, as therapy is aimed at encouraging repigmentation in areas where melanocytes have been destroyed by the autoimmune process. Therefore, dermatology services provided from 6/10/15 through 7/29/15 were medically indicated for this patient.
For the reasons provided, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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A 49-year-old female enrollee has requested reimbursement for Tempus xT gene panel performed on 3/16/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 2
A 49-year-old female enrollee has requested reimbursement for Tempus xT gene panel performed on 3/16/20. 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 Tempus is one of a number of multigene and molecular features assay of an individuals cancer cells. The hope is that it will indicate a specific drug that can target a mutation or molecular target. However, thus far, there is no clear data to indicate that using the assay in that way can reliably yield a treatment with significant clinical benefit. A randomized study by Le Tourneau and colleagues did not find that picking a treatment based on such an assay is superior to that using the oncologists judgment. Several reports indicate that the benefit from using such an assay is rare and unlikely. Therefore, the Tempus xT gene panel performed on 3/16/20 was not likely to have been more beneficial than any available standard therapy.
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A 58-year-old male enrollee has requested reimbursement for test for allergy or toxicity (immunoglobulin G (IgG) food sensitivity testing) performed on 3/14/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who has a history of diarrhea. | Upheld | Experimental | Summary Reviewer 3
A 58-year-old male enrollee has requested reimbursement for test for allergy or toxicity (immunoglobulin G (IgG) food sensitivity testing) performed on 3/14/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who has a history of diarrhea. The physician reviewer found that there is a lack of high-quality clinical literature supporting the use of IgG food allergy testing for the investigation of gastrointestinal symptoms or irritable bowel syndrome. Notably, a number of national and international medical societies have expressed recommendations against the use of this testing and concern about its ongoing use for this indication. The American Academy of Allergy, Asthma and Immunology and American College of Allergy, Asthma and Immunology practice guidelines state that IgG and IgG subclass antibody tests for food allergy do not have clinical relevance, are not validated, lack sufficient quality control, and should not be performed. The American Academy of Allergy, Asthma and Immunology guideline for management of adverse reactions to foods states that measurement of specific IgG antibodies to foods is unproven as a diagnostic tool. Thus, IgG food sensitivity testing performed on 3/14/18 was not likely to be of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The parent of a 10-year-old male enrollee has requested reimbursement for neuropsychological testing provided on 9/6/16, 9/8/16, 9/16/16, and 9/29/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees cognitive abilities | Upheld | Medical Necessity | Summary Reviewer
The parent of a 10-year-old male enrollee has requested reimbursement for neuropsychological testing provided on 9/6/16, 9/8/16, 9/16/16, and 9/29/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees cognitive abilities The physician reviewer found that there is a lack of support in the medical literature for the services at issue in this clinical setting. The American Academy of Pediatrics (AAP) recommend obtaining information from the teachers and parents of the student as part of the evaluation for ADHD. The evaluation should also include the Diagnostic and Statistical Manual of Mental Disorders criteria for ADHD. The documentation provided does not indicate that these recommended assessments were performed in this case. Assessment systems such as the Vanderbilt, Connors or the Behavior Assessment System for Children (BASC), are also recommended evaluation tests for ADHD. There is a lack of medical evidence to support neuropsychological testing in this clinical setting. The primary concern, in this patients case was academic functioning and possible ADHD. As such, the services at issue are not supported by the medical literature. Therefore, the neuropsychological testing provided on 9/6/16, 9/8/16, 9/16/16, and 9/29/16 were not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
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