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A 22-year-old female enrollee has requested reimbursement for Prometheus Anser IFX diagnostic testing performed on 1/16/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease.
this patient has Crohns disease, for which she had a colectomy and has been maintained on Humira. However, she had ulcerations in the terminal ileum which would be concerning for active disease on Humira. The testing at | Upheld | Experimental | Summary Reviewer 3
A 22-year-old female enrollee has requested reimbursement for Prometheus Anser IFX diagnostic testing performed on 1/16/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found this patient has Crohns disease, for which she had a colectomy and has been maintained on Humira. However, she had ulcerations in the terminal ileum which would be concerning for active disease on Humira. The testing at issue evaluates for adalimumab blood level and for antibodies to adalimumab. Due to the multitude of management options once a patient has no response to Humira and the fact that Humira has a wide array of adverse effects, it is important for the treating provider to have a roadmap of the nature of the patients clinical course. Thus, Anser ADA testing performed on 1/16/15 was likely to be of greater benefit than other alternatives. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned. | 1 |
A 50-year-old female enrollee has requested authorization and coverage for stretching devices (E1830 and E1399). The Health Insurer has denied this request indicating that the requested devices are not medically necessary for treatment of the enrollees medical condition status post hammertoe correction. | Upheld | Medical Necessity | Summary Reviewer
A 50-year-old female enrollee has requested authorization and coverage for stretching devices (E1830 and E1399). The Health Insurer has denied this request indicating that the requested devices are not medically necessary for treatment of the enrollees medical condition status post hammertoe correction. The physician reviewer found that the requested Dynasplint toe flexion system stretching devices are not medically necessary for treatment of the patients condition. There is a lack of sufficient evidence in the published medical literature to permit conclusions on the safety, efficacy and long-term outcomes of the proposed stretching devices. In this case, the use of static progressive stretch splint devices alone or combined with standard physical therapy is not medically necessary. In addition, there is a lack of documentation demonstrating that the patient is unable to benefit from standard physical therapy modalities because of an inability to exercise or the patient has participated in a treatment plan with documentation of no improvement for four months. Moreover, the use of patient-actuated serial stretch and bi-directional static progressive devices is not the standard of care in this clinical setting. All told, the request for stretching devices (E1830 and E1399) has not been established as medically necessary for the patients medical condition. Therefore, the requested devices are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 0 |
A 64-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing
performed on 8/14/19. The Health Insurer has denied this request and reported that the services
at issue were investigational for the evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 3
A 64-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing
performed on 8/14/19. 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 staging and prognosis of cutaneous melanoma has classically been
determined by applying the system spelled out by Balch. Mitotic index may add a bit to these
statistics. DecisionDx-Melanoma testing is an assay of 31 genes in a particular melanoma. It then
places that particular melanoma into either Class 1 or 2, with somewhat different risks of
metastasis by five years. It is not clear how the five-year DecisionDx-Melanoma data compares
to the ten-year Balch data. Most importantly, it has not been shown that one can use the
DecisionDx-Melanoma data to make important clinical decisions, such as the need for sentinel
node biopsy or the use of adjuvant therapy. Therefore, DecisionDx-Melanoma testing performed
on 8/14/19 was not likely to have been more beneficial than any available standard therapy.
| 0 |
The patient is a nine-year-old female with a history of autism spectrum disorder and a speech
delay. The patients parent has requested reimbursement for the ABA services provided from
12/1/21 through 5/13/22. The Health Insurer has denied the services at issue as not medically
necessary for the treatment of the patient. Therefore, the Health Insurer has denied coverage for
the services at issue.
the disorder are causing
impairment. In this case, the patient was assessed at 2.5 years of age using standardized measures.
The result of this assessment was a diagnosis of autism spectrum disorder. There is evidence in
the records that the patient was seen for re-evaluation. The assessment appeared to involve a record
review, the patients history with limited direct evaluation, and no standardized assessments. The
outcome of this assessment was that the provider recommended continuation of ABA and gave a
diagnosis of attention-deficit/hyperactivity disorder (A | Overturned | Medical Necessity | Summary
The patient is a nine-year-old female with a history of autism spectrum disorder and a speech
delay. The patients parent has requested reimbursement for the ABA services provided from
12/1/21 through 5/13/22. The Health Insurer has denied the services at issue as not medically
necessary for the treatment of the patient. Therefore, the Health Insurer has denied coverage for
the services at issue. This denial is the subject of this appeal and determination. The physician
reviewer found that Papatola and Lustig described the features that must be considered in order to
evaluate for medical necessity to be met for ABA services. Per these guidelines, a medical
diagnosis of autism using standardized measures such as the Autism Diagnostic Observation
Schedule, Second Edition (ADOS-2) and evidence that the symptoms of the disorder are causing
impairment. In this case, the patient was assessed at 2.5 years of age using standardized measures.
The result of this assessment was a diagnosis of autism spectrum disorder. There is evidence in
the records that the patient was seen for re-evaluation. The assessment appeared to involve a record
review, the patients history with limited direct evaluation, and no standardized assessments. The
outcome of this assessment was that the provider recommended continuation of ABA and gave a
diagnosis of attention-deficit/hyperactivity disorder (ADHD), inattentive type, and mixed
expressive-receptive language disorder. Given the lack of standardized assessment, these findings
should not be considered a replacement for the patients autism spectrum disorder diagnosis since
autism spectrum disorder and neurodevelopmental disorders are listed as active diagnoses along
with ADHD and mixed expressive-receptive language disorder in the records. In addition, the
CARD providers included an initial assessment and progress reports for numerous dates from 2017
through 2021 documenting the patients current functioning using standardized measures which
resulted in evidence-based treatment recommendations with measurable outcomes. Each
assessment contained standardized measures and reported measurable outcomes on treatment
goals which developed based on a comprehensive history and assessment of the patients skills
and interfering behaviors. Moreover, the services were provided in the least restrictive setting
possible and were required for purposes other than convenience. Furthermore, the patients
progress reports submitted by CARD demonstrated a measurable reduction in challenging
behaviors and an increase in independent functioning over time. The provider monitored the
maintenance and generalization of the patients reduction in challenging behaviors across settings,
staff, and more natural behavioral contingencies. Overall, the provider delivered the ABA therapy
in accordance with generally accepted practices and met the definition of medically necessary
ABA services from Papatola and Lustig. Finally, the ABA services provided from 12/1/21 through
5/13/22 were medically necessary per the Council of Autism Service Providers (CASP) practice
guidelines. An objective assessment and analysis of the patients condition by observing how the
environment affects the patients behavior, as evidenced through appropriate data collection was
included for review. Per the CARD reports, the patients ABA provider submitted an initial
assessment and progress reports dated from 2017 through 2021. Each assessment contained
standardized measures including the Vineland Adaptive Behavior Scales and reported measurable
outcomes on treatment goals. In this patients case, the appropriate context for the treatment of
two goals was low preference activities. These goals included sustaining attention for non-
preferred activities and non-social flexibility in the form of remaining calm when asked to stop or
prevented from engaging in expected preferred activities. While the clinical notes reference the
completion of homework on a couple of occasions, this information is to provide additional
information on the context of goal implementation and does not indicate intervention for goals that
are not identified in the treatment plan. The records do not suggest that the patient has significant cognitive impairment. The diagnostic report at age 2.5 indicates that the patient did not meet the
criteria for intellectual disability and further stated that although the patients scores on the Mullen
indicated a possibility of intellectual disability, given her young age and behavioral presentation
the evaluator was not able to evaluate her true abilities. The provider utilized the principles and
procedures of ABA such that the patients health, independence, and quality of life were improved.
On review of the records, the information presented in the progress report indicates steady progress
on both skill acquisition treatment goals and decreases in challenging behavior. In terms of
challenging behaviors, the provider systematically worked to create a behavior plan to reduce
challenging behaviors including tantrums, aggression, and noncompliance. The provider also
ensured that the patients behavior plan could be faded to more natural contingencies while
maintaining low levels of challenging behaviors across settings and people. Per the behavior plan,
working on non-preferred tasks for at least 15 minutes before accessing preferred activities was
one way to ensure that there were ample opportunities to ensure that the reduction of challenging
behaviors was maintained and generalized. The progress reports indicate ongoing modifications
to the treatment plan and behavior intervention plan based on data resulting from the patients
progress. In conclusion, given that the services rendered met both the medical necessity criteria
outlined by Papatola and Lustig and the core characteristics of ABA outlined by CASP, the ABA
treatment provided from 12/1/21 through 5/13/22 was medically necessary for the treatment of the
patients medical condition. | 1 |
A 45-year-old female enrollee has requested has requested reimbursement for intravenous immune globulin (IVIG) treatment provided from 3/14/16 through 4/22/16. The Health Insurer has denied this request indicating that the medication at issue was not medically necessary for treatment of the enrollees chronic inflammatory demyelinating polyneuropathy (CIDP).
In this case, the patient is diagnosed with CIDP and has had a good response to IVIG treatment with improved strength and activities of daily living. The delay in administration of IVIG treatment caused the CIDP to relapse. | Overturned | Medical Necessity | Summary Reviewer
A 45-year-old female enrollee has requested has requested reimbursement for intravenous immune globulin (IVIG) treatment provided from 3/14/16 through 4/22/16. The Health Insurer has denied this request indicating that the medication at issue was not medically necessary for treatment of the enrollees chronic inflammatory demyelinating polyneuropathy (CIDP). The physician reviewer found that IVIG is U.S. Food and Drug Administration (FDA) approved for the treatment of CIDP. In this case, the patient is diagnosed with CIDP and has had a good response to IVIG treatment with improved strength and activities of daily living. The delay in administration of IVIG treatment caused the CIDP to relapse. These findings support the medical necessity for IVIG treatment. As such, IVIG treatment provided from 3/14/16 through 4/22/16 has been established as medically necessary for treatment of the patients medical condition. Therefore, the medication at issue was medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 62-year-old female enrollee has requested reimbursement for hospital services provided on 2/6/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees dislocated thumb.
this case, the patient was admitted in stable condition and could have been treated at
The records indicated that the patients pain was controlled. | Upheld | Medical Necessity | Summary Reviewer
A 62-year-old female enrollee has requested reimbursement for hospital services provided on 2/6/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees dislocated thumb. The physician reviewer found the inpatient admission was not medically necessary in this patients case. Inpatient care is necessary when the patients signs, symptoms, and general medical condition can only be managed safely in an acute inpatient setting, when the patient requires diagnostic studies in an inpatient setting, or if it is medically necessary for the patient to remain in the acute inpatient setting. In this case, the patient was admitted in stable condition and could have been treated at a lower level of care. The documentation provided did not support acute exacerbations of chronic medical problems. The records indicated that the patients pain was controlled. She could have been treated at a lower level of care for the procedure. Per InterQual criteria for acute inpatient admission, the criteria was not met? in this patients case. As such, the hospital services provided on 2/6/17 were not medically necessary for the treatment of this 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. | 1 |
A 76-year-old male enrollee has requested reimbursement for the Oncotype DX Colon Cancer Assay (CPT 81525) performed on 10/25/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees stage II colon cancer. | Upheld | Experimental | Summary Reviewer 3
A 76-year-old male enrollee has requested reimbursement for the Oncotype DX Colon Cancer Assay (CPT 81525) performed on 10/25/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees stage II colon cancer. The physician reviewer found that it has been demonstrated in the medical literature that adjuvant chemotherapy is beneficial to patients with stage III colon cancer. However, the usefulness of adjuvant chemotherapy in patients with stage II cancer remains controversial. Some of the features that have been associated with a higher risk of recurrence in node-negative patients include poorly differentiated cancer, lymphovascular invasion, presentation with obstruction or perforation, or a T4 tumor (Rodriguez, et al). However, this patient has none of these features. In the absence of these high risk feature, the Oncotype DX Colon Cancer Assay (CPT 81525) performed on 10/25/17 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
The patient is a 60-year-old male who has been diagnosed with moderate to severe ulcerative colitis (pancolitis). The patient has requested authorization and coverage for Remicade 10 mg/kg every six weeks for eight months. The Health Insurer has denied this request and reported that the requested medication dosage is not medically necessary for the treatment of this patient. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 60-year-old male who has been diagnosed with moderate to severe ulcerative colitis (pancolitis). The patient has requested authorization and coverage for Remicade 10 mg/kg every six weeks for eight months. The Health Insurer has denied this request and reported that the requested medication dosage is not medically necessary for the treatment of this patient. The physician reviewer found that Remicade (infliximab) is FDA-approved and recommended for the treatment of ulcerative colitis. The increased dose requested in this case is commonly required during maintenance therapy with infliximab, and it can be effective. Large studies have shown that disease can be maintained in a majority of cases with increase of dose. American College of Gastroenterology guidelines for management of ulcerative colitis support the requested increase in Remicade dosage in patients with uncontrolled disease. Additionally, American Gastroenterological Association guidelines for management of ulcerative colitis support the requested increase in Remicade dosage in patients with low Remicade level if anti-Remicade antibodies are absent or at a low level, as in this case. The American Gastroenterological Association guidelines for therapeutic drug monitoring state that a Remicade level of 5 ug/mL is recommended, and over 10 ug/mL is highly likely to be effective; the level in this case is significantly lower. Although the patient does not have frankly uncontrolled clinical disease, there is a history of dysplasia and of pseudopolyps, which place the patient at risk for colorectal cancer and severe disease flare. For these reasons, an increase in dose to 10 mg/kg every 6 weeks is supported by current medical literature and guidelines. If therapy is continued at the current dose with low drug level, there is risk for a disease flare, uncontrolled disease, or uncontrolled disease manifesting as dysplasia and leading to colon cancer. Therefore, Remicade 10 mg/kg every six weeks for eight months is medically necessary for the treatment of this patient. | 1 |
A 37-year-old female enrollee has requested authorization and coverage for lymphaticovenous anastomosis and intraoperative indocyanine green lymphatic mapping. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. | Overturned | Experimental | Summary Reviewer 2
A 37-year-old female enrollee has requested authorization and coverage for lymphaticovenous anastomosis and intraoperative indocyanine green lymphatic mapping. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that the current medical evidence supports the requested services in this clinical setting. Baltzer and colleagues stated, aPatient selection is key to the success of lymphovenous anastomosis. Patients are selected who have clinical stage 1 or 2 lymphedema using the International Society for Lymphology classification. Patients who have been compliant with nonoperative measures and do not demonstrate considerable improvement in symptoms and quality of life should be considered for surgery. Proximal lymphedema can also improve after lymphovenous anastomosis performed in the distal extremity.a Akita and colleagues stated, aVascularized supraclavicular lymph node transfer is an effective technique for the treatment of advanced stage lower extremity lymphedema. Lymphaticovenular anastomosis is also effective, but to a lesser degree than vascularized surgical lymph node transfer. However, lymphaticovenular anastomosis is less invasive and requires a shorter hospital stay.a Lymphovenous anastomosis is an established surgical treatment for lower extremity lymphedema. Therefore, lymphaticovenous anastomosis and intraoperative indocyanine green lymphatic mapping is likely to be more beneficial than other available standard therapy.
| 1 |
A 54-year-old male enrollee has requested reimbursement for the Prometheus diagnostic panel performed on 11/24/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 3
A 54-year-old male enrollee has requested reimbursement for the Prometheus diagnostic panel performed on 11/24/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that the Prometheus diagnostic panel performed on 11/24/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. To assist in the diagnostic evaluation of patients with suspected IBD, serologic testing is utilized to accurately distinguish patients with IBD from patients with other gastrointestinal disorders. The Prometheus diagnostic panel examines the patterns among multiple classes of markers. This approach is indicated in cases that pose a diagnostic challenge and where the presentation remains confounded despite endoscopic and pathologic testing such as in this patient. Therefore, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 0 |
A 45-year-old female enrollee has requested authorization and coverage for arthrodesis, sacroiliac joint, percutaneous or minimally invasive (indirect visualization), with image guidance. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees back pain.
This patient presents with persistent severe right greater than left SI joint pain. Functional difficulty was documented in sitting tolerance, activities of daily living, and work ability. She was status post circumferential L3-S1 instrumented fusion in May 2014 with initial positive surgical benefit allowing return to work. She reported progressively worsening bilateral buttocks pain. There was evidence of long-term conservative treatment including medications, activity modification, SI joint injections, sacroiliac radiofrequency ablation, and physical therapy without sustained improvement. Clinical examination findings have documented SI joint tenderness with four positive sacroiliac provocative testing. There was radiographic evidence of bilateral sacroiliac arthropathy, right greater than left, consistent with adjacent segment degeneration. | Overturned | Medical Necessity | Summary Reviewer
A 45-year-old female enrollee has requested authorization and coverage for arthrodesis, sacroiliac joint, percutaneous or minimally invasive (indirect visualization), with image guidance. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees back pain. The physician reviewer found that the submitted documentation supports the medical necessity of the requested services in this clinical setting. This patient presents with persistent severe right greater than left SI joint pain. Functional difficulty was documented in sitting tolerance, activities of daily living, and work ability. She was status post circumferential L3-S1 instrumented fusion in May 2014 with initial positive surgical benefit allowing return to work. She reported progressively worsening bilateral buttocks pain. There was evidence of long-term conservative treatment including medications, activity modification, SI joint injections, sacroiliac radiofrequency ablation, and physical therapy without sustained improvement. Clinical examination findings have documented SI joint tenderness with four positive sacroiliac provocative testing. There was radiographic evidence of bilateral sacroiliac arthropathy, right greater than left, consistent with adjacent segment degeneration. Multiple SI joint injections have been documented with 100% relief on the day of injection and diminishing response over time. In this patients case, the current evidence based medical guideline and peer-reviewed surgical indications for SI joint fusion have been met. In sum, arthrodesis, sacroiliac joint, percutaneous or minimally invasive (indirect visualization), with image guidance is medically necessary for treatment of this patient. Therefore, for the reasons stated above, the requested services are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
patient is a 45-year-old male who has been diagnosed with psoriasis with total body surface area of greater than 10%, severely affecting his quality of life. He has tried and failed various topical therapies as well as phototherapy. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 45-year-old male who has been diagnosed with psoriasis with total body surface area of greater than 10%, severely affecting his quality of life. He has tried and failed various topical therapies as well as phototherapy. The physician reviewer found that Psoriasis is a chronic inflammatory skin disease. Patients typically present with sharply demarcated, inflammatory, erythematous plaques with characteristic silver-white scaling due to epidermal hyperproliferation and parakeratosis secondary to the inflammation. Psoriasis has a high negative impact on the quality of life, especially in patients moderately or severely affected by the disease. The long-term use of traditional systemic therapies is frequently unacceptable because of renal, hepatic, pulmonary toxicity and limited efficacy. Traditional systemic therapies for psoriasis, including methotrexate and cyclosporine, have a well-documented array of toxicities, particularly end-organ toxicities.
The U.S. Food and Drug Administration has approved secukinumab (Cosentyx) to treat adults with moderate-to-severe plaque psoriasis. In clinical trials, subcutaneous secukinumab was more effective than placebo, etanercept and ustekinumab at improving psoriasis symptoms (with high skin clearance). Secukinumab was more effective than placebo in studies specifically investigating efficacy in the difficult-to-treat palmoplantar and nail psoriasis populations. Studies specifically
investigating drug efficacy in these populations are rare, and treatment options for these patients are limited. Therefore, Cosentyx 300 mg dose, two pens are medically necessary for the treatment of this patient. | 1 |
patient is a 52-year-old female with a history of refractory back pain, depression, anxiety,
and chronic pain disorder status post pain pump placed in 2019. The provider has recommended
placement of a percutaneous implantation of spinal cord stimulator.
In this case, the patient has chronic low
back pain that has been non-responsive to medication | Overturned | Medical Necessity | Summary
The patient is a 52-year-old female with a history of refractory back pain, depression, anxiety,
and chronic pain disorder status post pain pump placed in 2019. The provider has recommended
placement of a percutaneous implantation of spinal cord stimulator. The physician reviewer
found that at issue is whether the requested percutaneous implantation of neurostimulator
electrode array, epidural, is medically necessary for treatment of this patient. A prospective,
multicenter, randomized controlled trial was conducted evaluating the long-term quality of life
improvement for patients with chronic intractable back and leg pain using spinal cord stimulation
(Amirdelfan, et al.). The authors reported that of the 171 patients who received a permanent
spinal cord stimulation device implant, a higher proportion of spinal cord stimulation patients
had marked improvement of their disability on the Oswestry Disability Index (ODI) to a moderate
or minimal impact on their daily function versus the control group. The authors concluded that,
In addition to superior pain relief, 10 kHz spinal cord stimulation provides long-term
improvements in quality of life and functionality for subjects with chronic low-back and leg pain.
Similarly, a systematic review and meta-analysis performed by Head and colleagues evaluated a
variety of spinal cord stimulation systems and device parameters for use in patients with chronic
low back and leg pain. The authors concluded that data from level 1 randomized controlled trials
have elevated the status of spinal cord stimulation to a safe and effective alternative for the
treatment of neuropathic low back pain and leg pain. In this case, the patient has chronic low
back pain that has been non-responsive to medication management, physical therapy, epidural
steroid injections, cognitive therapy and intrathecal pain pump. Based on the level one evidence
to support the usage of spinal cord stimulation therapy for patients with chronic low back and
leg pain that is refractory to other forms of conservative care, the requested spinal cord
stimulation is appropriate for treatment of this patients chronic low back pain. Therefore, the
requested percutaneous implantation of neurostimulator electrode array, epidural, is medically
necessary for treatment of this patient.
| 1 |
A 29-year-old female enrollee has requested authorization and coverage for the LINX procedure. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. | Overturned | Experimental | Summary Reviewer 1
A 29-year-old female enrollee has requested authorization and coverage for the LINX procedure. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that there is a lack of randomized controlled trials with long-term follow-up demonstrating that LINX is safer or more effective than Nissen fundoplication or other surgical anti-reflux procedures. American College of Gastroenterology guidelines for the management of reflux disease also state that more evidence is needed before LINX can be recommended. Skubleny and colleagues concluded, aLong-term comparative outcome data past one year are needed in order to further understand the efficacy of magnetic sphincter augmentation.a Additionally, LINX (more than surgical fundoplication) is associated with severe dysphagia, requiring endoscopic intervention. Sheu and Rattner concluded, aThe long-term safety and efficacy of LINX - both alone and in comparison to current GERD therapies - remains to be determined.a LINX has significant potential adverse effects and can be associated with poor outcomes. Therefore, the requested LINX procedure is not likely to be more beneficial than any available standard therapy.
| 0 |
A 55-year-old male enrollee has requested authorization and coverage for the LINX lower esophageal sphincter augmentation device. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD). | Overturned | Experimental | Summary Reviewer 3
A 55-year-old male enrollee has requested authorization and coverage for the LINX lower esophageal sphincter augmentation device. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD). The physician reviewer found that there is a lack of randomized controlled trials with long-term follow-up demonstrating that LINX is safer or more effective than Nissen fundoplication or other surgical anti-reflux procedures. One evidence review concluded that the long-term safety and efficacy of LINX - both alone and in comparison to current GERD therapies - remains to be determined (Sheu and Rattner). Another best-evidence review concluded that long-term comparative outcome data past one year are needed in order to further understand the efficacy of magnetic sphincter augmentation (Skubleny, et al). Adverse events, such as erosion through the esophagus, have been reported in the period after U.S. Food and Drug Administration (FDA) approval (Bauer, et al). The currently available peer-reviewed literature does not support the conclusion that LINX is more likely to be beneficial in this case than standard treatment including surgical fundoplication (Sheu, et al; Ganz, et al). American College of Gastroenterology guidelines for the management of reflux disease also state that more evidence is needed before LINX can be recommended (Katz, et al). For these reasons, the requested LINX lower esophageal sphincter augmentation device is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 63-year-old female enrollee has requested reimbursement for inpatient hospitalization services provided from 3/19/18 through 3/20/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees low back pain.
In this case, the patient was admitted in stable condition and could have been treated at a lower level of care. Her pain was controlled with oral medications, and there was | Upheld | Medical Necessity | Summary Reviewer
A 63-year-old female enrollee has requested reimbursement for inpatient hospitalization services provided from 3/19/18 through 3/20/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees low back pain. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. 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. In this case, the patient was admitted in stable condition and could have been treated at a lower level of care. Her pain was controlled with oral medications, and there was no indication for significant neurologic compromise or infection. All told, inpatient hospitalization services provided from 3/19/18 through 3/20/18 were not medically necessary for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
The parent of a three-year-old female enrollee has requested authorization and coverage for homocysteine, Factor V Leiden, and methylene tetrahydrofolate reductase (MTHFR), testing performed on 6/4/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee whose parent was diagnosed with idiopathic venous embolism and was positive for the MTHFR mutation and Factor V Leiden deficiency.
. The patients mother tested negative for the FVL mutation. As such, testing the patient, who was asymptomatic, was not indicated. Further, the patients mother was the only person in the family with thrombosis and she tested negative for this mutation. Though the patients mother has had blood clots at an early age and in unusual places, the patient herself is not reported to have thrombosis. | Upheld | Experimental | Summary Reviewer 2
The parent of a three-year-old female enrollee has requested authorization and coverage for homocysteine, Factor V Leiden, and methylene tetrahydrofolate reductase (MTHFR), testing performed on 6/4/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee whose parent was diagnosed with idiopathic venous embolism and was positive for the MTHFR mutation and Factor V Leiden deficiency. The physician reviewer found that according to the records, the services at issue were not likely to have been beneficial to this patient. The patients mother tested negative for the FVL mutation. As such, testing the patient, who was asymptomatic, was not indicated. Further, the patients mother was the only person in the family with thrombosis and she tested negative for this mutation. Though the patients mother has had blood clots at an early age and in unusual places, the patient herself is not reported to have thrombosis. The American College of Medical Genetics (ACGM) has a practice guideline regarding genotyping of MTHFR. Studies of MTHFR have been plentiful and have focused on a wide variety of conditions, including vascular disease, neural tube defects, mental illness, autism, and cancer, to name a few. However, after a comprehensive review, ACMG found that there is insufficient evidence for the clinical utility of MTHFR polymorphism testing. The ACMG guidelines do not recommend testing for MTHFR. In this patients case, the records do not support that this test provided any clinical utility. All told, homocysteine, FVL, and MTHFR testing performed on 6/4/16 was not likely to have been more effective than other standard modalities for the evaluation of this patient. Therefore, for the reasons stated above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 26-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 4/15/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. | Upheld | Experimental | Summary Reviewer 1
A 26-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 4/15/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that the prognosis of cutaneous melanoma has classically been determined by the staging system spelled out by Balch. Mitotic index is thought to add a bit to these statistics. DecisionDx-Melanoma testing is an assay of the molecular and genetic changes in an individualas melanoma cells. It then classifies that melanoma based on the five-year risk of metastasis. It is not clear how the five-year DecisionDx-Melanoma data compares to the ten-year Balch data. Most importantly, it is not known if DecisionDx-Melanoma data can be used to make clinical decisions, such as whether to do a sentinel node or not. Therefore, DecisionDx-Melanoma testing performed on 4/15/19 was not likely to have been more beneficial than other available standard therapy.
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A 31-year-old female has requested reimbursement for lab tests that measure the levels of
medication, adalimumab (ADA) performed on 8/1/22. The Health Insurer has denied this request
indicating that the testing at issue was considered investigational for evaluation of the insureds
ulcerative colitis. | Overturned | Experimental | Summary Reviewer 2
A 31-year-old female has requested reimbursement for lab tests that measure the levels of
medication, adalimumab (ADA) performed on 8/1/22. The Health Insurer has denied this request
indicating that the testing at issue was considered investigational for evaluation of the insureds
ulcerative colitis. The physician reviewer found that on review of the current medical literature,
there is insufficient clinical data provided to support the ADA drug levels and antibody testing
performed in this patients evaluation and treatment. The records do not demonstrate that the ADA
testing was recommended to evaluate the patient to confirm dosing or due to suspected failure of
medication. In the setting of suspected drug failure, additional testing such as stool cultures should
also be performed to rule-out other potential causes of the patients disease flare. A recent meta-
analysis concluded that, Routine proactive therapeutic drug monitoring to target biologic
concentration to specific thresholds, regardless of disease activity, did not offer clinical benefit in
patients with inflammatory bowel disease treated with TNF-alpha antagonists in randomized
controlled trials conducted to date (Nguyen, et al.). All told, the lab tests that measure the levels
of medication, ADA performed on 8/1/22 were not likely to be more beneficial for evaluation of
the patients medical condition than any available standard therapy.
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A 45-year-old female enrollee has requested authorization and coverage for autologous chondrocyte implantation of the knee. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees knee pain.
. In this case, the documentation shows significant loss of the articular cartilage of the patellofemoral joint. | Overturned | Experimental | Summary Reviewer 2
A 45-year-old female enrollee has requested authorization and coverage for autologous chondrocyte implantation of the knee. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees knee pain. The physician reviewer found that the surfaces of the bones in the knee are covered with hyaline articular cartilage, a very smooth, frictionless surface allowing movement in the joint and acting as a shock absorber. In this case, the documentation shows significant loss of the articular cartilage of the patellofemoral joint. Articular cartilage has very little capacity for self-repair, so damage may be permanent. Various methods have been used to try to repair cartilage. Autologous chondrocyte implantation involves laboratory culture of cartilage-producing cells from the knee and then implanting them into the defect. Studies have revealed that the results with autologous chondrocyte implantation are superior to microfracture. When combined with a patellofemoral stabilization procedure, it is effective in relieving pain and promoting healing of articular defects of the patellofemoral joint. The medical evidence supports the requested services in this clinical setting. In sum, autologous chondrocyte implantation of the knee is likely to be more effective than other treatment options. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 53-year-old female enrollee has requested has requested authorization and coverage for Sovaldi and Daklinza. The Health Insurer has denied this request indicating that the requested medications are not medically necessary for treatment of the enrollees hepatitis C virus. | Overturned | Medical Necessity | Summary Reviewer
A 53-year-old female enrollee has requested has requested authorization and coverage for Sovaldi and Daklinza. The Health Insurer has denied this request indicating that the requested medications are not medically necessary for treatment of the enrollees hepatitis C virus. 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 the fibrosis stage. In treatment-naive genotype 3 patients, therapy is recommended with Sovaldi and Daklinza for 12 weeks. This is based on the ALLY-3 study, which showed a cure rate of 97% (Nelson, et al; Hezode, et al). Delay in treatment may result in decreased survival (Jezequel, et al). For these reasons, treatment with Sovaldi and Daklinza is medically necessary for the treatment of this patients hepatitis C infection. Therefore, the requested medications are 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 lab testing (Factor V Leiden genetic testing) provided on 12/16/14. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition.
the patient does not have a personal history of venous thromboembolism (VTE) | Upheld | Experimental | Summary Reviewer 3
A 48-year-old female enrollee has requested reimbursement for lab testing (Factor V Leiden genetic testing) provided on 12/16/14. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that there is a lack of support in the peer-reviewed literature for the Factor V Leiden genetic testing performed in this clinical setting. In this case, the patient does not have a personal history of venous thromboembolism (VTE). Moreover, the testing at issue is not the standard of care as it is not supported for population testing. The position statement by the North American Menopause Society (NAMS) states Women with a previous history of VTE, obese women, or women who possess a Factor V Leiden mutation are at increased risk of VTE with HT use. However NAMS does not recommend Factor V Leiden population testing such as in this case, with no indication for testing by medical or family history. 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 63-year-old female enrollee has requested reimbursement for laboratory testing (collagen crosslink testing) performed on 2/25/17. 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 osteoporosis. | Overturned | Experimental | Summary Reviewer 1
A 63-year-old female enrollee has requested reimbursement for laboratory testing (collagen crosslink testing) performed on 2/25/17. 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 osteoporosis. The physician reviewer found that osteoporosis is a condition of thinning of the bones which leads to increased risk of fracture. It is defined by the World Health Organization (WHO) as a bone mineral density of 2.5 standard deviations or more below the mean peak bone mass (average of young, healthy adults) as measured by dual-energy x-ray absorptiometry (DEXA). Bone mineral density (BMD) assessment, via DEXA, is still the criterion standard for evaluation and diagnosis of osteoporosis. However, because changes in bone mass and density in response to antiresorptive therapy account for only a small portion of the predicted fracture risk reduction, markers of bone turnover may be a useful adjunct in monitoring of osteoporotic patients treated with antiresorptive agents. The medical evidence suggests that biochemical markers could be useful in making therapeutic decisions because, in general, the higher the bone remodeling and bone loss rates, the greater the concentration of bone biochemical markers in blood or urine. There is sufficient support for the services at issue in this clinical setting. All told, laboratory testing (collagen crosslink testing) performed on 2/25/17 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 29-year-old female enrollee has requested authorization and coverage for compound medication of sirolimus cream 1%. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollee, who has Klippel Trenaunay syndrome. | Overturned | Experimental | Summary Reviewer 3
A 29-year-old female enrollee has requested authorization and coverage for compound medication of sirolimus cream 1%. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollee, who has Klippel Trenaunay syndrome. The physician reviewer found that Klippel Trenaunay syndrome is characterized by the triad of cutaneous capillary malformations, asymmetrical disturbed growth of soft tissues and/or bone, and venous and lymphatic malformations. Recent publications emphasize the potential interest of sirolimus, an inhibitor of mammalian target of rapamycin (mTOR) activity, as a treatment option for cutaneous vascular malformations and PIK3CA-related overgrowth spectrum (PROS). Sirolimus has been used successfully with a good safety profile. The requested medication is an appropriate medical treatment for bleeding induced by venous and lymphatic malformation associated with Klippel Trenaunay syndrome. Thus, compound medication of sirolimus cream 1% is likely to be more efficacious than other treatment options. Based upon the information set forth above, the requested medication is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 41-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 5/26/20. 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 3
A 41-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 5/26/20. 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 Melanoma is a cancer that is curable in its earliest stages. Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76-1.0 mm. Metastases to regional lymph nodes may be amenable to excision, but this suggests a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha. The data on DecisionDx-Melanoma testing has not made it part of routine analysis after sentinel lymph node biopsy. There has also been some lack of consistency between various genes being used as biomarkers. As such, the test is novel, and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. Therefore, DecisionDx-Melanoma testing performed on 5/26/20 was not likely to have been more beneficial than any available standard therapy.
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A 38-year-old female enrollee has requested authorization and coverage for Humira 40 mg weekly. The Health Insurer has denied this request indicating that the requested medication dosage is considered investigational for treatment of the enrollees ulcerative colitis. | Overturned | Experimental | Summary Reviewer 1
A 38-year-old female enrollee has requested authorization and coverage for Humira 40 mg weekly. The Health Insurer has denied this request indicating that the requested medication dosage is considered investigational for treatment of the enrollees ulcerative colitis. The physician reviewer found that anti-tumor necrosis factor agents, such as Humira and Remicade, have demonstrated efficacy for induction and maintenance of remission in patients with moderate to severe inflammatory bowel disease, but the response is not universal. More than one-third of patients do not respond to induction therapy (primary nonresponse) and even among initial responders, the response wanes over time, sometimes resulting in disease exacerbation. Relative to this patients desire to conceive, after week 20 of pregnancy, chimeric antibodies cross the placenta. However, the consequence of having anti-tumor necrosis factor in a neonate has not been studied until recently. Recent population-based data find that there is no increased risk for birth defects. According to the most recent practice guideline, pregnant women receiving maintenance therapy should continue therapy, and the decision to stop after week 20 is individualized. Because this patient is in remission, there is no need to stop now, nor is there significant concern for an increased risk of an adverse pregnancy outcome. Pregnancy desire is not a contraindication to anti-tumor necrosis factor treatment. If a mother is not treated through her pregnancy, she runs the risk of disease activity, which will be detrimental to her health and her pregnancy. Evidence supports the safety and efficacy of anti-tumor necrosis therapy before and during pregnancy and should not delay the decision to start or optimize therapy. In this patients case, Humira 40 mg weekly is likely to be of greater benefit than other available treatment options. Based upon the information set forth above, the requested medication dosage 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 41-year-old male enrollee has requested authorization and coverage for the LINX device. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 3
A 41-year-old male enrollee has requested authorization and coverage for the LINX device. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found the LINX device is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The LINX device, which is U.S. Food and Drug Administration (FDA) approved, is laparoscopically implanted around the esophagus at the esophagogastric junction to mechanically augment the function of the lower esophageal sphincter (LES) for the treatment of GERD. LINX has shown efficacy up to four years in the reduction of the amount of pathologic esophageal acid exposure (Lipham, et al). A multi-institutional, non-randomized, prospective case series of 100 patients by Ganz and colleagues evaluated patients before and after sphincter augmentation with a magnetic device. The authors found exposure to esophageal acid decreased, reflux symptoms improved, and use of proton-pump inhibitors decreased. Based on the minimal invasive nature of the procedure, documented safety and efficacy data in multiple studies, and FDA approval, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 62-year-old male enrollee has requested reimbursement for the Life Vest provided from 6/10/15 through 7/10/15. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees dilated cardiomyopathy. | Upheld | Experimental | Summary Reviewer 2
A 62-year-old male enrollee has requested reimbursement for the Life Vest provided from 6/10/15 through 7/10/15. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees dilated cardiomyopathy. The physician reviewer found that placement of a prophylactic defibrillator is not recommended until a period of time after myocardial infarction has elapsed, where continued severe left ventricular dysfunction is documented to persist in spite of appropriate treatment (Russo, et al). Placement of a prophylactic defibrillator (wearable or implantable) before this time has not been demonstrated to improve patient outcomes. Studies assessing the efficacy of prophylactic defibrillators early after diagnosis of myocardial infarction and reduced ejection fraction of 35% or less before ventricular function has had a chance to recover have not demonstrated improved outcome (Steinbeck, et al). A prophylactic wearable external defibrillator is indicated only if accepted criteria for an implantable defibrillator are met and an implantable defibrillator could not be placed, needed to be significantly delayed or required explantation. Therefore, the Life Vest provided from 6/10/15 through 7/10/15 has not been demonstrated by scientific literature as likely to have been more beneficial in treating this patients medical condition than standard alternatives. Based upon the information set forth above, I have determined 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 57-year-old female enrollee has requested reimbursement for myocardial perfusion imaging test performed on 1/31/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition.
the patient has some chest/epigastric symptoms and mild hypertension. Her baseline EKG is described as abnormal as well.
has some risk factors for coronary artery disease and an inability to | Overturned | Medical Necessity | Summary Reviewer
A 57-year-old female enrollee has requested reimbursement for myocardial perfusion imaging test performed on 1/31/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that the patient has some chest/epigastric symptoms and mild hypertension. Her baseline EKG is described as abnormal as well. The planned orthopedic surgery with general anesthesia would be considered an intermediate risk surgical procedure in terms of cardiac complications. She has some risk factors for coronary artery disease and an inability to exert herself enough to determine reasonable functional capacity due to knee arthritis, so the assessment of functional capacity as a risk marker is not possible in this situation. In addition, she is not asymptomatic, as she has some epigastric discomfort symptoms as well as a baseline abnormal EKG, and the description and presentation of angina pectoris can be more often atypical in women as well. Based on these preoperative factors, her limited mobility (impairing an assessment of her functional capacity) and her epigastric symptoms, a pharmacologic nuclear stress test was reasonable and medically indicated to assess cardiac risk in this patient prior to the planned orthopedic surgery. Therefore, the myocardial perfusion imaging test performed on 1/31/20 was medically necessary for the evaluation of this patient. | 1 |
A 32-year-old male enrollee has requested authorization and coverage for Gammagard liquid (immune globulin (human) IV or subcutaneous solution 5 gm/50 ml and Gamunex-C. The Health Insurer has denied this request and reported that the medication at issue is investigational for the treatment of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 2
A 32-year-old male enrollee has requested authorization and coverage for Gammagard liquid (immune globulin (human) IV or subcutaneous solution 5 gm/50 ml and Gamunex-C. The Health Insurer has denied this request and reported that the medication at issue is investigational for the treatment of the enrollees medical condition. The physician reviewer found that the medical evidence supports the requested medication in this patients case. The records document peripheral motor neuropathy, which is consistent with chronic inflammatory demyelinating polyneuropathy. Chronic inflammatory demyelinating polyradiculoneuropathy is a heterogeneous disorder that includes diverse clinical presentations and immunopathological mechanisms. Intravenous immune globulin is currently the standard of care in the treatment of patients with this condition. This patient is likely to benefit from intravenous immune globulin over other treatments. In sum, Gammagard liquid (immune globulin (human) IV or subcutaneous solution 5 gm/50 mL) and Gamunex-C is likely to be more beneficial than other treatment options.
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The parent of an 11-year-old male enrollee has requested authorization and coverage for orthoptic and pleoptic training. 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.
eyes. The providers letter indicates that the patient has several psychological disorders. | Upheld | Medical Necessity | Summary Reviewer
The parent of an 11-year-old male enrollee has requested authorization and coverage for orthoptic and pleoptic training. 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 fails to demonstrate the medical necessity of the requested services. The patients optometric record carries no diagnosis of ocular pathology, only the functional diagnosis of convergence excess. There is no documentation provided of any illness, injury, or significant organic malfunctioning of the patients eyes. The providers letter indicates that the patient has several psychological disorders. There is insufficient evidence supporting the medical efficacy of the requested orthoptic and/or pleoptic training. Per the American Academy of Ophthalmology, there is a lack of evidence-based information supporting the effectiveness of vision therapy. Vision therapy is not within the standard of medical care for children with reading difficulties, attention problems, or other psychological disorders. Therefore, the requested orthoptic and/or pleoptic training is not medically necessary for the treatment of this patient. | 1 |
A 39-year-old male enrollee has requested reimbursement for inpatient services from 4/30/17 through 5/4/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees dermatofibrosarcoma protuberans (DFSP) of the left shoulder. | Overturned | Medical Necessity | Summary Reviewer
A 39-year-old male enrollee has requested reimbursement for inpatient services from 4/30/17 through 5/4/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees dermatofibrosarcoma protuberans (DFSP) of the left shoulder. The physician reviewer found that the optimal outcome for application of a split thickness skin graft to a wound is 100% engraftment. Multiple studies have shown that the application of a wound VAC facilitates the skin graft take, thereby reducing the incidence of graft loss and the subsequent events of: 1) potential infection, 2) additional wound care, 3) possible repeated operations to apply additional skin grafts. In addition, immobilization of the engrafted area reduces shear forces and increases the rate and overall percentage of successful skin grafts. While VAC therapy can be used in the outpatient setting, given the irregular contour of the shoulder and the ongoing need to assess and maintain the negative pressure to ensure optimal function of the VAC device, inpatient care is the optimal setting for continuous VAC device use. Therefore, given the location of the tissue defect on the left shoulder and the inherent immobility required, as well as the indicated use of a wound VAC, inpatient care for the provision of these services was medically indicated. Therefore, the inpatient services provided from 4/30/17 through 5/4/17 were medically necessary for the treatment of this patients medical condition. In sum, based on the reasons stated above, the services at issue were medically necessary for the treatment of this patients medical condition. The Health Insurers denial should be overturned.
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The parent of a 15-year-old female enrollee has requested authorization and coverage for Focalin XR 25mg, 1 capsule every morning. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees attention deficit disorder (ADD) without hyperactivity. | Overturned | Medical Necessity | Summary Reviewer
The parent of a 15-year-old female enrollee has requested authorization and coverage for Focalin XR 25mg, 1 capsule every morning. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees attention deficit disorder (ADD) without hyperactivity. The physician reviewer found in a study by Borgheini, brand name medications had a higher bioavailability than generic medication. This same study also indicated that illness recurred quite readily after brand was switched to generic. Desmarais and colleagues in a review article citing studies from 1974 through 2010 raise concern about the efficacy of generic drugs versus their brand equivalents, suggesting that amount of active ingredients in the generic was quite different than similarly dosed brand names. These studies indicate that use of generic medications may lead to higher dosing requirements and may lead to relapse of symptoms or need for more intensive services. Medical guidelines generally recommend change in medication after two to three failed medication trials. In this is a case, Adderall XR, Concerta and Metadate CD and Vyvanse were tried and failed in some significant way. While there may be other products on the market with similar ingredients, medical studies have shown that some individual patients may respond better to one product over another. Upon review of this patients submitted medical records, this appears to be one of those cases. Therefore, the requested Focalin XR is medically necessary for treatment of the patients medical condition.
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A 44-year-old male has requested authorization and coverage for total disc arthroplasty at the levels of L4-L5 and L5-S1. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. | Overturned | Experimental | Summary Reviewer 2
A 44-year-old male has requested authorization and coverage for total disc arthroplasty at the levels of L4-L5 and L5-S1. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that the Single-level lumbar disc replacement was U.S. Food and Drug Administration (FDA) approved in 2006 with the ProDisc-L based on good mid to long-term studies. The FDA approved the first two-level lumbar disc replacement in 2020, again with ProDisc-L implant showing good results. The study by Rasouli and colleagues involved a cohort of 159 patients. The authors concluded, aMultilevel total disc replacement preserves range of motion at the individual total disc replacement levels. Most significantly, the non-operative adjacent level maintains its preoperative range of motion at two to six years postoperatively. At up to six years of follow-up, there has been no need for revision or adjacent-segment surgery. Patients also demonstrate significant improvement in pain and disability at latest follow-up.a In a clinical case series involving 122 patients by Scott-Young and colleagues, multilevel total disc replacement for multilevel degenerative disc disease demonstrated favorable and sustained clinical outcomes at mid-term to long-term follow-up. In a comparison of a two-level versus one-level total disc replacement by Zigler and Ohnmeiss, patients undergoing two-level total disc replacement improved significantly postoperatively based on visual analog scales and Oswestry scores, and there were no significant differences in outcome scores when comparing one- and two-level total disc replacement. In sum, there is sufficient support for the requested services in this clinical setting. Therefore, total disc arthroplasty at the levels of L4-L5 and L5-S1 is likely to be more beneficial than any available standard therapy.
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A 65-year-old male enrollee has requested reimbursement for gene testing provided on 9/26/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 3
A 65-year-old male enrollee has requested reimbursement for gene testing provided on 9/26/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that Melanoma is a cancer that is curable in its earliest stages. Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76-1.0 mm. Metastases to regional lymph nodes may be amenable to excision, but this suggests a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha. The data on DecisionDx-Melanoma has not made it part of routine analysis after sentinel lymph node biopsy. There has also been some lack of consistency between various genes being used as biomarkers. As such, the test is novel, and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. Thus, gene testing provided on 9/26/18 was not likely to have been of greater benefit than other methods of evaluating this patient.
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The parent of a 16-year-old transgender male enrollee has requested authorization and coverage for 19350 (nipple/areola reconstruction). The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees gender dysphoria.
In this case, the patient has had ample time living as male and is on testosterone. | Overturned | Medical Necessity | Summary Reviewer
The parent of a 16-year-old transgender male enrollee has requested authorization and coverage for 19350 (nipple/areola reconstruction). The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees gender dysphoria. The physician reviewer found that chest surgery for transmasculine youth is a common intervention for gender dysphoria. There is no justification for limiting coverage for treatment to adults. The World Professional Association for Transgender Health (WPATH) notes that chest surgery in transgender males could be carried out earlier [than age 18], preferably after ample time of living in the desired gender role and after one year of testosterone treatment. In this case, the patient has had ample time living as male and is on testosterone. Chest surgery is a safe and effective treatment for gender dysphoria in transmasculine youth. Olson-Kennedy and colleagues stated, Chest dysphoria was high among transmasculine youth, and surgical intervention positively affected both youth and adults. The current medical evidence supports the requested services in this patients case. Therefore, 19350 (nipple/areola reconstruction) is medically necessary for the treatment of this patient. | 1 |
A 25-year-old female has requested authorization and coverage for intravenous ceftriaxone. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees medical condition.
The records do not describe a tick bite or the development of a rash at the site of the bite. Her
The notes state she is being treated for neurological infection, but | Upheld | Experimental | Summary Reviewer 1
A 25-year-old female has requested authorization and coverage for intravenous ceftriaxone. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees medical condition. The physician reviewer found there is a lack of support for the requested medication in this clinical setting. There is a lack of evidence that this patient has any infection. The records do not describe a tick bite or the development of a rash at the site of the bite. Her symptoms are non-specific. There is also no evidence for either Babesia or Brucella infection. One month of ceftriaxone is accepted therapy for Borrelia infection if cardiac disease is present, neurological involvement is documented or joint involvement is found. In this case, none of these forms of infection is present. The notes state she is being treated for neurological infection, but there is no evidence to support this diagnosis. The current medical evidence has not demonstrated that greater than 28 days of therapy is of benefit for patients with Lyme disease, and the records do not demonstrate that she has Lyme disease. In sum, intravenous ceftriaxone is not likely to be superior over other treatment options. Based upon the information set forth above, the requested medication is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 24-year-old female enrollee has requested authorization and coverage for lower esophageal
myotomy, transoral (peroral endoscopic myotomy) (POEM) and one inpatient day. The Health
Plan has denied this request indicating that the requested service is investigational for the
treatment of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 1
A 24-year-old female enrollee has requested authorization and coverage for lower esophageal
myotomy, transoral (peroral endoscopic myotomy) (POEM) and one inpatient day. The Health
Plan has denied this request indicating that the requested service is investigational for the
treatment of the enrollees medical condition. The physician reviewer found that there is
sufficient support for the requested service in this clinical setting. The American
Gastroenterological Association best-practice guideline states that if the expertise is available,
POEM should be considered as treatment option comparable with laparoscopic Heller myotomy
for any of the achalasia syndromes. The American Society for Gastrointestinal Endoscopy has
recently published a statement based on available evidence, stating that POEM is a potential
attractive option for the treatment of achalasia that offers a minimally invasive endoscopic
approach to myotomy with the potential for a durable response to therapy. Clinical studies and
trials have shown comparable efficacy with surgery when expertise in POEM is available.
However, despite comparable efficacy, POEM is significantly less invasive than surgical
intervention, resulting in less postoperative pain and a more rapid recovery. In this patient with
symptoms including dysphagia and regurgitation, as well as failure of pneumatic dilation, the use
of POEM is supported by current medical literature and guidelines. Therefore, lower esophageal
myotomy, transoral POEM and one inpatient day is likely to be more beneficial than any available
standard therapy.
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patient is a 58-year-old female with a history of acromegaly. She underwent a transsphenoidal resection of a pituitary mass in 2005, followed by radiation therapy.
(GH) secreting pituitary adenoma and resultant excess in circulating levels of GH and | Overturned | Medical Necessity | Summary Reviewer
The patient is a 58-year-old female with a history of acromegaly. She underwent a transsphenoidal resection of a pituitary mass in 2005, followed by radiation therapy. The physician reviewer found that the acromegaly is a chronic, progressive, and potentially lethal disease caused by a growth hormone (GH) secreting pituitary adenoma and resultant excess in circulating levels of GH and insulin-like growth factor-1 (IGF-1). Transsphenoidal pituitary adenoma resection is generally the first-line therapy for acromegaly. Pharmacologic agents available for treatment of persistent acromegaly include somatostatin-receptor ligands, GH-receptor antagonists and, in selected cases, dopamine agonists. Somatostatin receptor ligands, such as Sandostatin LAR, are considered the mainstay in the medical management of acromegaly. However, this agent requires deep tissue injection and can be associated with substantial treatment burden or deleterious long-term sequelae, including injection site pain, nodules, bruising, inflammation, and scarring. Injectable somatostatin receptor ligands may also negatively affect patient quality of life; patients have reported anxiety, frustration, and loss of independence caused by the injections. Accordingly, oral octreotide capsules (OOCs), such as Mycapssa, were developed as a potential treatment option to address challenges encountered with injectable medications. Recent data suggests that maintenance of mean IGF-1 levels for the OOC group from baseline to end of treatment indicates that patients who switched from injectable somatostatin receptor ligands to oral octreotide capsules retain biochemical control of acromegaly. The medical evidence supports the requested medication in this clinical setting. Therefore, Mycapssa 20 mg capsule DR is medically necessary for the treatment of this patient.
| 1 |
A 30-year-old male enrollee has requested reimbursement for chemical dependency intensive outpatient treatment provided from 5/22/18 through 5/29/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions.
He was medically and psychiatrically stable, and his Wellbutr
He was cooperative, motivated, and participating in his treatment plan. No new problems had arisen. The patient demonstrated good insight and motivation, and | Upheld | Medical Necessity | Summary Reviewer
A 30-year-old male enrollee has requested reimbursement for chemical dependency intensive outpatient treatment provided from 5/22/18 through 5/29/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. The patient did not demonstrate or complain of post-acute withdrawal symptoms. He was not a danger to himself or others. There were no emotional, behavioral, cognitive, or impulsive symptoms which would have prevented step down to outpatient level of care. He was medically and psychiatrically stable, and his Wellbutrin could have been managed in an outpatient setting. There was no evidence of a high degree of impulsivity, agitation, depression, mania, hallucinations, or any other significant symptom that would interfere with his care. He was cooperative, motivated, and participating in his treatment plan. No new problems had arisen. The patient demonstrated good insight and motivation, and there was no evidence to suggest that he would not successfully continue his recovery in the outpatient setting, in conjunction with community support, such as 12-step program with counseling. All told, chemical dependency intensive outpatient treatment provided from 5/22/18 through 5/29/18 was not medically necessary for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
A 43-year-old male enrollee has requested reimbursement for Anser IFX testing performed on 8/09/15. 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 43-year-old male enrollee has requested reimbursement for Anser IFX testing performed on 8/09/15. 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 some evidence exists that low serum levels of infliximab and/or the presence of antibodies to infliximab may play a role in primary or secondary response failures. Antidrug antibodies develop in a substantial number of patients and may be responsible for acute drug infusion reactions as well as delayed hypersensitivity reactions. In a large percent of patients who develop antibodies, such antibodies may disappear after continued treatment. The reasons for therapeutic failures remain unclear. Some evidence exists that low serum levels of infliximab or the presence of infliximab antibodies have an adverse effect on the clinical outcome of a patients response to treatment. However, there are few well-controlled clinical trials to confirm that use of the Anser IFX testing leads to improved patient outcomes or quality of life as opposed to the standard method of treatment. The clinical utility of measuring drug antibody concentrations has not been established, and it has not been established how patient management would change based on test results. Limited retrospective evidence describes changes in management after measurement to anti-drug antibodies, but does not compare these management changes to those made in the absence of anti-drug antibody measurement. In sum, the superior efficacy of Anser IFX testing performed on 8/09/15 has not been established. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
A 44-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 8/26/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees medical condition. | Upheld | Medical Necessity | Summary Reviewer
A 44-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 8/26/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees medical condition. The physician reviewer found that Tomosynthesis provides advantages relate to the tomographic nature of tomosynthesis and the associated ability to separate dense glandular elements from underlying architectural distortion. However, the technique is new and there is a lack of long-term studies showing an increased survival rate when tomosynthesis has been used versus cases where two-dimensional (2D) imaging alone has been performed. According to Friedewald and colleagues Addition of tomosynthesis to digital mammography was associated with a decrease in recall rate and an increase in cancer detection rate. Further studies are needed to assess the relationship to clinical outcomes. In sum, the use of 2D imaging alone is supported by the peer-reviewed literature, however the addition of tomosynthesis was not medically necessary. Therefore, the services at issue were not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
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patient is a 13-year-old male with a history of idiopathic isolated growth hormone (GH)
deficiency. The provider has recommended continued treatment with GH therapy. The Health
Insurer has denied the requested treatment as not medically necessary for the treatment of the
patients medical condition.
Loche). In this case, the patient failed to respond
to glucagon and clonidine stimulating testing. An MRI of the patients brain revealed a relatively
small pituitary gland for the patients age. | Overturned | Medical Necessity | Summary
The patient is a 13-year-old male with a history of idiopathic isolated growth hormone (GH)
deficiency. The provider has recommended continued treatment with GH therapy. 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 Skytrofa is U.S. Food and Drug Administration (FDA) approved for
the treatment of pediatric patients with GH deficiency. According to Maniatis and colleagues,
pediatric patients treated with once-weekly Skytrofa showed continued improvement of height
SDs through the second year of therapy without excess advancement of bone age. The failure of
two standard GH provocative tests, combined with a small pituitary gland, is consistent with a
diagnosis of pediatric GH deficiency (Ibba and Loche). In this case, the patient failed to respond
to glucagon and clonidine stimulating testing. An MRI of the patients brain revealed a relatively
small pituitary gland for the patients age. Furthermore, based on this patients standing height and
contemporary bone age, the patients predicted adult height before initiating treatment with
Skytrofa was 65.9 inches, which is more than two SDs below his estimated MPTH of 72 inches.
Therefore, prior to initiating treatment with Skytrofa, this patient met generally accepted and FDA-
approved diagnostic criteria for pediatric GH deficiency. Moreover, the records provided for
review indicate that the patient has been tolerating and responding well clinically to Skytrofa, as
demonstrated by the increase in the patients growth velocity. For these reasons, the requested
Skytrofa is medically necessary for the treatment of this patient.
| 1 |
A 58-year-old male enrollee has requested authorization and coverage for magnetic resonance imaging (MRI) of the pelvis. 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 58-year-old male enrollee has requested authorization and coverage for magnetic resonance imaging (MRI) of the pelvis. 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 American Urologic Association guidelines note that the clinical indications for the use of MRI in the management of prostate cancer are rapidly evolving. Mowatt and colleagues noted owing to the relative paucity of reliable data, further studies are required. The authors noted that prospective studies are required in men with suspected prostate cancer and elevated PSA levels but previously negative biopsy comparing the utility of the MRI with both a magnetic resonance-guided/-directed biopsy session and an extended 14-core TRUS-guided biopsy scheme against a reference standard of histopathological assessment of biopsied tissue obtained via saturation biopsy, template biopsy or prostatectomy specimens. At this time, standard transrectal ultrasound and guided biopsy of prostate remains the initial diagnostic modality. Therefore, the requested MRI of the pelvis is not medically necessary for the evaluation of this patient. | 0 |
The patient is a 64-year-old female who presented to the neurosurgery clinic after being diagnosed with a right carotid occlusion and high-grade stenosis of the left carotid artery. She has a history of several transient ischemic attacks with complaints of dizziness as well as headaches and blurry vision. The patient underwent left internal carotid artery angioplasty and stenting on 2/27/18. The angiogram noted high-grade stenosis of the right vertebral artery is 70%, and a computed tomography (CT) perfusion revealed decreased blood flow to the right occipital lobe. During the postoperative examination, she continued with symptomatic dizziness, and the recommendation was made for right vertebral artery angioplasty with stenting. The provider noted she is at increased risk for stroke should she become dehydrated or hypotensive given the carotid occlusion and stenosis of the right vertebral artery. The patient has requested coverage for vertebral artery angioplasty. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of this patient. This patient has been recommended to undergo a vertebral artery angioplasty due to vertebral artery occlusion. The patient underwent left internal carotid artery angioplasty and stenting on 2/27/18 and was noted to have a follow-up on 3/06/18 where she indicated she was doing well. She did complain of one episode of dizziness. | Upheld | Experimental | Summary Reviewer 3
The patient is a 64-year-old female who presented to the neurosurgery clinic after being diagnosed with a right carotid occlusion and high-grade stenosis of the left carotid artery. She has a history of several transient ischemic attacks with complaints of dizziness as well as headaches and blurry vision. The patient underwent left internal carotid artery angioplasty and stenting on 2/27/18. The angiogram noted high-grade stenosis of the right vertebral artery is 70%, and a computed tomography (CT) perfusion revealed decreased blood flow to the right occipital lobe. During the postoperative examination, she continued with symptomatic dizziness, and the recommendation was made for right vertebral artery angioplasty with stenting. The provider noted she is at increased risk for stroke should she become dehydrated or hypotensive given the carotid occlusion and stenosis of the right vertebral artery. The patient has requested coverage for vertebral artery angioplasty. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of this patient. This patient has been recommended to undergo a vertebral artery angioplasty due to vertebral artery occlusion. The patient underwent left internal carotid artery angioplasty and stenting on 2/27/18 and was noted to have a follow-up on 3/06/18 where she indicated she was doing well. She did complain of one episode of dizziness. While treatment with the requested surgical intervention may be appropriate in certain situations, it does not appear this patient is an appropriate candidate. There is lack of documentation indicating that the stenosis continues to make the patient symptomatic. The follow-up note indicated the patient was doing well and only had one episode of dizziness. Given the above, the requested vertebral artery angioplasty 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 60-year-old female enrollee has requested reimbursement for collagen crosslinks laboratory tests performed on 1/2/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees osteoporosis.
The requesting provider indicated that these tests were ordered to monitor compliance and response to anti-resorptive therapy. | Overturned | Experimental | Summary Reviewer 3
A 60-year-old female enrollee has requested reimbursement for collagen crosslinks laboratory tests performed on 1/2/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees osteoporosis. The physician reviewer found that according to the Clinicians Guide to Prevention and Treatment of Osteoporosis, biochemical markers of bone turnover may predict risk of fracture independently of bone density in untreated patients, predict rapidity of bone loss in untreated patients, and help determine adequacy of patient compliance and persistence with osteoporosis therapy. These statements are also supported by Burch and colleagues who performed a review regarding the use of bone turnover markers for monitoring the response to osteoporosis treatment. In this case, identifying baseline and subsequently monitoring markers of bone turnover to assist with best therapy options for the patient is medically appropriate and in line with sound medical practice. The requesting provider indicated that these tests were ordered to monitor compliance and response to anti-resorptive therapy. All told, these tests were likely to be more efficacious to guide the therapy for this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 43-year-old female enrollee has requested authorization and coverage for right sacroiliac joint fusion. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees low back pain.
lumbosacral spine. The MRI did not show any abnormality in the sacroiliac joint and did not suggest that the sacroiliac joint had been violated by the bone graft. | Upheld | Experimental | Summary Reviewer 3
A 43-year-old female enrollee has requested authorization and coverage for right sacroiliac joint fusion. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees low back pain. The physician reviewer found based on the current peer-reviewed medical literature, the requested sacroiliac fusion is not likely to be beneficial for management of chronic pain. Anatomical studies performed after the patient had an L3-4 level fusion and laminectomy suggests likely continuing pain generation from intervertebral disc and facet joints at multiple levels of the lumbosacral spine. The MRI did not show any abnormality in the sacroiliac joint and did not suggest that the sacroiliac joint had been violated by the bone graft. The reliance of steroid local injection into the sacroiliac joint as an indicator for identification of a specific pain generator, i.e. the sacroiliac joint is not sufficient to localize pain generation from the sacroiliac joint in the face of multifactorial chronic pain. In summary, it is not likely to be beneficial for this patient to undergo sacroiliac instrumentation and fusion as a treatment method for her condition of chronic pain. 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 57-year-old male insured has requested reimbursement for a gene test (CPT 0047U) provided on
3/10/22. The Health Insurer has denied this request indicating that the services at issue were considered
investigational for the evaluation of the insureds prostate cancer.
that this patient presented with Gleason 3+3=6 prostate cancer
with a PSA of 7.74 ng/mL. | Overturned | Experimental | Summary Reviewer 1
A 57-year-old male insured has requested reimbursement for a gene test (CPT 0047U) provided on
3/10/22. The Health Insurer has denied this request indicating that the services at issue were considered
investigational for the evaluation of the insureds prostate cancer. The physician reviewer found that the
records available for review indicate that this patient presented with Gleason 3+3=6 prostate cancer
with a PSA of 7.74 ng/mL. The current National Comprehensive Cancer Network (NCCN) guidelines
recommend testing with Oncotype DX post-biopsy for patients with low or favorable intermediate-risk
prostate cancer. Retrospective studies have shown that molecular assays following prostate biopsy or
radical prostatectomy can provide prognostic information independent of NCCN risk groups (Chang, et
al.). One review studied whether the score for a prostate genetic test was associated with prostate
cancer pathology findings for patients who had their prostate removed (Covas Moschovas, et al.). The
authors found that their findings may help surgeons in counseling patients on surgical options for
prostate cancer. Overall, the data suggest that patients with clinically localized disease may be
considered for the use of tumor-based molecular assays, and this testing is considered the standard of
care in guiding treatment decision-making. Accordingly, the gene test (CPT 0047U) provided on 3/10/22
was likely to have been more beneficial for the evaluation of the patients medical condition than any
available standard therapy.
| 1 |
An 18-year-old female enrollee has requested reimbursement for the gene testing performed on 9/1/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees major depressive disorder. | Upheld | Experimental | Summary Reviewer 2
An 18-year-old female enrollee has requested reimbursement for the gene testing performed on 9/1/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees major depressive disorder. The physician reviewer found that genetic testing results show if a patient is a normal responder of certain classes of medications, may be more or less likely to respond to certain medications, is at low risk of certain adverse events, at higher risk of others, or may have decreased activity of a certain enzyme activity. However, the fact that there was a gene mutation does not demonstrate that the addition of l-methylfolate will have an effect on this patients treatment. The length of time she was treated with these medications was not given, nor does she appear to have been tried on other classes of antidepressants. All of these issues could have been assessed by the provider during follow-up, and adjusted for by changes in medication regimen including increased/decreased dose, other augmentation strategies, or discontinuation for a variety of reasons. In addition, plasma levels may be higher or lower due to differences in hepatic metabolism that varies in every individual. Furthermore, there is a lack of large randomized trials supporting the use of genetic testing as effective in guiding the clinician towards choosing a medication regimen. Accordingly, the gene testing performed on 9/1/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 63-year-old male enrollee has requested reimbursement for Decision Dx Assay testing performed on 7/18/16. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees melanoma.T
In this case, the patient presented with melanoma of 0.83 mm Breslow depth located on his back. | Upheld | Experimental | Summary Reviewer 3
A 63-year-old male enrollee has requested reimbursement for Decision Dx Assay testing performed on 7/18/16. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees melanoma.The physician reviewer found the Decision Dx Assay testing performed on 7/18/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The National Comprehensive Cancer Network (NCCN) guidelines indicate that genetic testing such as the Decision Dx Melanoma testing should not be used outside of a clinical trial setting. In this case, the patient presented with melanoma of 0.83 mm Breslow depth located on his back. The use of Decision Dx Assay testing is not the standard of care in the treatment of the patients melanoma. As such, the testing at issue is not expected to impact the treatment or outcome of the patients melanoma. Therefore, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
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 2
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 the submitted documentation fails to demonstrate the superior efficacy of the services at issue. The current medical evidence does not support IgG food sensitivity testing in this clinical setting. The American College of Gastroenterology notes that immunoglobulin A (IgA) anti-tissue transglutaminase antibody is the preferred single test for detection of celiac disease in patients over the age of two years. In this patients case, celiac disease had already been endoscopically ruled out. Thus, IgG food sensitivity testing performed on 3/14/18 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 52-year-old female enrollee has requested authorization and coverage for gene test (gene expression profiling) performed on 9/20/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee who has been diagnosed with cutaneous melanoma. | Upheld | Experimental | Summary Reviewer 2
A 52-year-old female enrollee has requested authorization and coverage for gene test (gene expression profiling) performed on 9/20/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee who has been diagnosed with cutaneous melanoma. The physician reviewer found that a commercial gene expression profile test (DecisionDX melanoma) has been developed in patients with stage I and II cutaneous melanoma. However, there are no definitive data regarding its use for risk classification in patients with cutaneous melanoma, and this test does not currently have a role in determining which patients are candidates for adjuvant immunotherapy, either as a standard of care or as part of clinical trials according to published data available. Per the National Comprehensive Cancer Network guidelines, while there is interest in newer prognostic molecular techniques such as gene expression profiling to differentiate benign from malignant neoplasms, or melanomas at low versus high risk for metastasis, routine (baseline) genetic testing of primary cutaneous melanomas (before or following SLNB) is not recommended outside of a clinical study (trial). The gene test (gene expression profiling) performed on 9/20/16 was not likely to have been of greater benefit than available standard therapy for the evaluation of this patients medical condition. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 33-year-old female enrollee has requested reimbursement for the residential mental health treatment services provided from 3/2/17 through 3/16/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health issues.
In this particular case, the patient presented with co-occurring bipolarity and anxiety. Patients with bipolar disorder spend a disproportionate time in the depressed phase.
the patient consolidated treatment gains and remained engaged in active treatment. | Overturned | Medical Necessity | Summary Reviewer
A 33-year-old female enrollee has requested reimbursement for the residential mental health treatment services provided from 3/2/17 through 3/16/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health issues. The physician reviewer found that the modern psychiatric practice aims to place patients in the least restrictive treatment setting. In general, community intervention settings optimize treatment gains while episodic placement in more restrictive settings can be clinically appropriate for patients with significant mental illness. The American Psychiatric Association (APA) states that the provider should determine the least restrictive setting for treatment that will be most likely not only to address the patients safety, but also to promote improvement in the patients condition. In this particular case, the patient presented with co-occurring bipolarity and anxiety. Patients with bipolar disorder spend a disproportionate time in the depressed phase. This is of particular relevance since it has been well-established in both clinical practice and the medical literature, such as the definitive Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study, that anxiety-ridden mood disorders are difficult to treat and in general have poorer outcomes. Further, the patient had previously failed treatment in a less restrictive setting. Thus, the residential admission was indicated. During the disputed timeframe, the patient consolidated treatment gains and remained engaged in active treatment. However, discharge on 3/2/17 would have been premature and more than likely would have resulted in undue morbidity and re-admission. The services and setting were safe, appropriate and consistent with good practice, while the duration of the admission aligned with community standards. Additionally, the services provided were reasonably expected to improve her condition and prevent a more serious episode of illness. Considering the clinical presentation and perusal of the peer-reviewed literature, the residential mental health treatment services provided from 3/2/17 through 3/16/17 were medically necessary for treatment of the patients behavioral health condition. Based on the foregoing discussion, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned. | 1 |
A 60-year-old male enrollee has requested reimbursement for the subtalar arthrodesis provided on 11/23/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees hallux valgus. | Upheld | Experimental | Summary Reviewer 2
A 60-year-old male enrollee has requested reimbursement for the subtalar arthrodesis provided on 11/23/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees hallux valgus. The physician reviewer found that calcaneal osteotomy has been demonstrated to be an effective procedure to control a painful flat foot. However, the concurrent procedure, subtalar arthroereisis, has not been demonstrated in large, randomized controlled clinical trials to provide long-term benefits beyond that anticipated with conservative measures. The data on subtalar arthroereisis in the published medical literature is inadequate to draw scientific conclusions. All told, the subtalar arthrodesis provided on 11/23/15 was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 55-year-old female enrollee has requested authorization and coverage for LINX Reflux Management System (code 43284) and one inpatient bed day. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 1
A 55-year-old female enrollee has requested authorization and coverage for LINX Reflux Management System (code 43284) and one inpatient bed day. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that the U.S. Food and Drug Administration has approved the LINX Reflux Management System for lower esophageal sphincter augmentation. Eligible patients for the procedure include those with inadequate symptom control with acid suppression therapy, including patients with mild to moderate gastroesophageal reflux disease and a hiatal hernia less than 3 cm. This patient meets those specific criteria. The device is a ring made up of a series of magnets that have sufficient attraction to increase the lower esophageal sphincter closure pressure, but allow for food passage with swallowing. Based upon a prospective study by Lipham and colleagues that included 44 patients, the mean total percent time that pH was less than 4 was reduced from 11.9 percent at baseline to 3.8 percent at three years. A recent study comparing the LINX procedure with laparoscopic fundoplication was performed by Reynolds and colleagues. The authors found that gastroesophageal reflux disease patients had similar control of reflux symptoms after both LINX and fundoplication. The inabilities to belch and vomit were significantly fewer with LINX, along with a significantly lower incidence of severe gas-bloat symptoms. Therefore, the LINX Reflux Management System (code 43284) and one inpatient day are likely to be superior over other treatment options.
| 0 |
The patient is a nine-year-old female. The patient has requested reimbursement for neuropsychological testing performed from 1/18/20 through 8/13/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of this patient.
Neuropsychological testing indicated that the patient had a complex combination of ADHD combined subtype, non-verbal learning disorders in math and reading, dysgraphia/dyspraxia, and dysthymia with symptoms of anxiety and depression. The patientas symptoms were interfering with her social, academic and family functioning. She was noted to be at risk of social isolation, peer rejection and bullying. | Overturned | Medical Necessity | Summary Reviewer
The patient is a nine-year-old female. The patient has requested reimbursement for neuropsychological testing performed from 1/18/20 through 8/13/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of this patient. The physician reviewer found that the submitted documentation supports the medical necessity of the services at issue. Neuropsychological testing indicated that the patient had a complex combination of ADHD combined subtype, non-verbal learning disorders in math and reading, dysgraphia/dyspraxia, and dysthymia with symptoms of anxiety and depression. The patientas symptoms were interfering with her social, academic and family functioning. She was noted to be at risk of social isolation, peer rejection and bullying. The neuropsychological testing and school evaluations that were performed were the only means by which the patientas complex combination of conditions could be clarified, and appropriate intervention instituted. Therefore, neuropsychological testing performed from 1/18/20 through 8/13/20 was medically necessary for the evaluation of this patient. | 1 |
A 19-year-old male enrollee has requested reimbursement for procedure codes 86671 x 2 and 86021 x 3 performed on 2/14/20. 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
A 19-year-old male enrollee has requested reimbursement for procedure codes 86671 x 2 and 86021 x 3 performed on 2/14/20. 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 Inflammatory bowel disease (IBD) is a heterogeneous group of chronic inflammatory disorders of the gastrointestinal tract with two main distinguishable entities, Crohnas disease (CD) and ulcerative colitis (UC). IBD-unclassified (IBD-U) is a diagnosis that covers the agreya zone of diagnostic uncertainty between UC and CD. Current diagnosis of IBD relies on the clinical, endoscopic, radiological, histological and biochemical features, but this approach has shortcomings, especially in cases of overlapping symptoms of CD and UC. The need for a diagnostic tool that would improve the conventional methods in IBD diagnosis directed the search towards potential immunological markers, since an aberrant immune response against microbial or endogenous antigens in a genetically susceptible host seems to be implicated in IBD pathogenesis. The spectrum of antibodies to different microbial antigens and autoantibodies associated with IBD is rapidly expanding. However, in this patientas case, where a prior diagnosis of left-sided ulcerative colitis has already been rendered, the provideras reliance on marker testing as the final arbiter as to whether patient instead has CD is not standard of care and is not indicated in lieu of gold standard colonoscopy with biopsies. Therefore, procedure codes 86671 x 2 and 86021 x 3 performed on 2/14/20 were not likely to have been more beneficial than other available standard therapy.
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The patient is a 36-year-old male who is under evaluation for gastroesophageal reflux disease (GERD). The patient experiences severe sub-xiphoid pain with exercise or lying down to sleep. The patients symptoms typically occur when eating calorie rich food. The patient has some symptoms consistent with gastroparesis although his gastric emptying scan was normal. He has had an overall poor response to proton pump inhibitor (PPI) therapy. On manometry he has a low lower esophageal sphincter (LES) pressure with small-medium sized hiatal hernia. A pH study was borderline positive with a low DeMeester score. The patient has requested authorization and coverage for transoral incisionless fundoplication (TIF) with EsophyX device. The Health Insurer has denied this request as investigational. The | Upheld | Experimental | Summary Reviewer 1
The patient is a 36-year-old male who is under evaluation for gastroesophageal reflux disease (GERD). The patient experiences severe sub-xiphoid pain with exercise or lying down to sleep. The patients symptoms typically occur when eating calorie rich food. The patient has some symptoms consistent with gastroparesis although his gastric emptying scan was normal. He has had an overall poor response to proton pump inhibitor (PPI) therapy. On manometry he has a low lower esophageal sphincter (LES) pressure with small-medium sized hiatal hernia. A pH study was borderline positive with a low DeMeester score. The patient has requested authorization and coverage for transoral incisionless fundoplication (TIF) with EsophyX device. The Health Insurer has denied this request as investigational. The requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. TIF is a minimally invasive treatment for GERD that is performed in the outpatient setting. In the medical literature, Wendling and colleagues reported in a recent systematic review that TIF appears to provide symptomatic relief with reasonable levels of patient satisfaction at short-term follow-up. However, the authors noted that a well-designed prospective clinical trial is needed to assess the effectiveness and durability of TIF as well as to identify the patient population that will benefit from this procedure. In sum, there is a lack of sufficient controlled data to show that TIF is non-inferior to fundoplication or that the procedure has long-term efficacy. For the reasons provided, the request for TIF with EsophyX device is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 46-year-old female enrollee has requested authorization and coverage for ketamine infusion and one day inpatient stay. The Health Insurer has denied this request indicating that the requested services are considered experimental/investigational for treatment of the enrollees peripheral neuropathy status post chemotherapy treatment. | Upheld | Experimental | Summary Reviewer 3
A 46-year-old female enrollee has requested authorization and coverage for ketamine infusion and one day inpatient stay. The Health Insurer has denied this request indicating that the requested services are considered experimental/investigational for treatment of the enrollees peripheral neuropathy status post chemotherapy treatment. The physician reviewer found based on the documentation submitted for review, there is a lack of support demonstrating a diagnosis of complex regional pain syndrome. In addition, the current research is inconclusive in regards to ketamine for the treatment of chemotherapy induced peripheral neuropathy, which the patient does have a diagnosis (Hershman, et al; Ewertz, et al). In addition, ketamine does not help for all types of neuropathic pain and research is still ongoing (OBrien, et al). For the reasons provided, the request for inpatient ketamine infusion is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld. | 1 |
A 58-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma (laboratory service code 84999) rendered on 8/25/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees cutaneous melanoma.
. The physician reviewer found that this patient is a 58-year-old male who developed malignant melanoma on the skin of left anterior shoulder with a Breslows depth of approximately 0.51 mm. The DecisionDx- Melanoma gene assay reported on 8/25/17 revealed class 1A molecular signature associated with a
five years. The patient has requested reimbursement for DecisionDx-Melanoma (laboratory service code 84999) rendered on 8/25/17. The Health Insurer denied this request indicating that the services at issue were considered investigational for the evaluation of the patients cutaneous melanoma. | Upheld | Experimental | Summary Reviewer 1
A 58-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma (laboratory service code 84999) rendered on 8/25/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees cutaneous melanoma.
. The physician reviewer found that this patient is a 58-year-old male who developed malignant melanoma on the skin of left anterior shoulder with a Breslows depth of approximately 0.51 mm. The DecisionDx- Melanoma gene assay reported on 8/25/17 revealed class 1A molecular signature associated with a low risk of recurrence within five years. The patient has requested reimbursement for DecisionDx-Melanoma (laboratory service code 84999) rendered on 8/25/17. The Health Insurer denied this request indicating that the services at issue were considered investigational for the evaluation of the patients cutaneous melanoma.
There is a lack of peer reviewed medical literature to support the superior efficacy of the services at issue in this patients case. Melanoma staging is characterized by the American Joint Committee on Cancer (AJCC) system that defines cutaneous melanoma stages from 0-IV. DecisionDx-Melanoma assay 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 II suggestive of a high risk of metastasis. Sidiropoulos and colleagues noted 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 II. 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 1 with a low risk of near term (within five years) metastatic disease. While DecisionDx-Melanoma signature may be an independent predictor of metastasis risk, additional studies and peer reviewed published literature are needed to show its efficacy over the available standard methods of therapy.Therefore, for the reasons stated above, the services at issue were not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 31-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 12/18/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. | Upheld | Experimental | Summary Reviewer 3
A 31-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 12/18/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that Melanoma is a cancer that is curable in its earliest stages. Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76-1.0 mm. Metastases to regional lymph nodes may be amenable to excision, but this suggests a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha. The data on DecisionDx-Melanoma testing has not made it part of routine analysis after sentinel lymph node biopsy. There has also been some lack of consistency between various genes being used as biomarkers. As such, the test is novel, and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. All told, DecisionDx-Melanoma testing performed on 12/18/19 was not likely to have been more beneficial than other methods of evaluating this patient.
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A 54-year-old female enrollee has requested authorization and coverage for panniculectomy. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees medical condition.
In this case, the patient presents with evidence of a symptomatic lower abdominal pannus in the setting of a need for repair of a ventral and incisional hernias. Her symptoms include skin breakdown over the lower aspect of the abdomen in the region of the groins and vertical scarring. | Overturned | Medical Necessity | Summary Reviewer
A 54-year-old female enrollee has requested authorization and coverage for panniculectomy. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation establishes the medical necessity of the requested surgery. In this case, the patient presents with evidence of a symptomatic lower abdominal pannus in the setting of a need for repair of a ventral and incisional hernias. Her symptoms include skin breakdown over the lower aspect of the abdomen in the region of the groins and vertical scarring. In addition, the surgical plan of panniculectomy is to allow for greater exposure of the hernias for repair and to assist in the healing of the abdominal wall reconstruction, presumably by placing the incision in an area not directly overlying the hernias. Photographs support that the lower abdomen is a source of her functional issues. According to Manahan and colleagues The abdominal panniculus may cause disabling rashes, pain, physical limitation, back strain, and cosmetic deformity, and symptoms are more marked the heavier the panniculus. Panniculectomy can treat these symptoms. This is the case for this patient and thus, panniculectomy is medically necessary for treatment of the patients medical condition. Given the above reasons, the requested services are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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A 35-year-old male enrollee has requested authorization and coverage for Actemra 400 mg/ 20 ml vial. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees anti-neutrophil cytoplasmic autoantibodies (ANCA) associated crescentic and immune complex gl | Upheld | Experimental | Summary Reviewer 1
A 35-year-old male enrollee has requested authorization and coverage for Actemra 400 mg/ 20 ml vial. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees anti-neutrophil cytoplasmic autoantibodies (ANCA) associated crescentic and immune complex glomerulonephritis. The physician reviewer found in this clinical setting, the patients disease is advanced, thereby lowering likelihood of a significant response to treatment with the requested medication. In addition, Actemra is not U.S. Food and Drug Administration (FDA) approved for this patients diagnosis. Also, the documentation infers that the patients underlying chronic kidney disease may not be the sole cause of his progressive renal condition. Given the lack of FDA indication, combined with the low likelihood of benefit with his advanced disease, Actemra 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.
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A 44-year-old female enrollee has requested reimbursement for doxycycline capsules delayed release 40 mg received on 5/22/18. The Health Insurer has denied this request indicating that the medication at issue was not medically necessary for treatment of the enrollee, who has a history of hypersensitivity reaction affecting the periocular area.
at issue. The records document a hypersensitivity reaction affecting the periocular area.
carries a diagnosis of rosacea and has already failed a one-month course of immediate-release 50 mg doxycycline. | Upheld | Medical Necessity | Summary Reviewer
A 44-year-old female enrollee has requested reimbursement for doxycycline capsules delayed release 40 mg received on 5/22/18. The Health Insurer has denied this request indicating that the medication at issue was not medically necessary for treatment of the enrollee, who has a history of hypersensitivity reaction affecting the periocular area. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the medication at issue. The records document a hypersensitivity reaction affecting the periocular area. Per the Health Insurer, the medication at issue cannot be approved unless the patient carries a diagnosis of rosacea and has already failed a one-month course of immediate-release 50 mg doxycycline. The medication at issue, doxycycline capsules delayed release 40 mg, is not considered to be superior or more efficacious than the preferred, generic immediate-release formula of doxycycline 50 mg. In fact, given the degree of inflammation, higher doses of doxycycline would be preferred for treatment of this eruption. Thus, doxycycline capsules delayed release 40 mg received on 5/22/18 were not medically necessary for the treatment of this patient. Therefore, the medication at issue was not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
A 33-year-old female enrollee has requested reimbursement for the Anser IFX testing performed on 2/18/16. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees small bowel Crohns disease. | Upheld | Experimental | Summary Reviewer 1
A 33-year-old female enrollee has requested reimbursement for the Anser IFX testing performed on 2/18/16. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees small bowel Crohns disease. The physician reviewer found the Anser IFX testing performed on 2/18/16 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. In this case there was concern of an infusion reaction due to pre-formed ATI. In addition, the testing confirms that the patients symptoms were an infusion reaction and allowed for planning for subsequent infusions. Therefore, in this clinical setting the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 25-year-old male enrollee has requested reimbursement for substance abuse residential treatment services provided from 7/22/17 through 8/3/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees polysubstance and alcohol abuse.
He had no comorbid medical conditions and he was psychiatrically stable.
He was motivated and working the program. He was cooperative and participating in his treatment plan. Although the patient continued to | Upheld | Medical Necessity | Summary Reviewer
A 25-year-old male enrollee has requested reimbursement for substance abuse residential treatment services provided from 7/22/17 through 8/3/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees polysubstance and alcohol abuse. The physician reviewer found that the patients post-acute withdrawal symptoms were not severe in nature. He was not a danger to himself or others, nor was he aggressive. There were no emotional, behavioral, cognitive, or impulsive symptoms that would warrant residential level of care. He had no comorbid medical conditions and he was psychiatrically stable. His medications could have been managed in an ambulatory setting. There was no evidence of a high degree of impulsivity, agitation, depression, mania, hallucinations, or any other significant symptom that would interfere with his care. He was motivated and working the program. He was cooperative and participating in his treatment plan. Although the patient continued to require further treatment to develop and solidify coping skills, this did not require the residential structure. No new problems had arisen and there was no evidence to indicate that returning him to his environment would lead to destabilization. Thus, as of 7/22/17, the patient no longer met the criteria for residential level of care. Accordingly, the substance abuse residential treatment services provided from 7/22/17 through 8/3/17 were not medically necessary for treatment of the patients medical condition. Based on the foregoing discussion, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
A 39-year-old female enrollee has requested authorization and coverage for cervical transection
and avulsion of extraspinal nerve. 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 has a significant history of neck pain and was
diagnosed with cervical spondylosis. She had excellent pain relief following medial branch blocks of the C2-C3 and C3-C4 facets bilaterally. | Upheld | Experimental | Summary Reviewer 2
A 39-year-old female enrollee has requested authorization and coverage for cervical transection
and avulsion of extraspinal nerve. The Health Insurer has denied this request and reported that
the requested services are investigational for the treatment of the enrollees medical condition.
The physician reviewer found that this patient has a significant history of neck pain and was
diagnosed with cervical spondylosis. She had excellent pain relief following medial branch blocks of the C2-C3 and C3-C4 facets bilaterally. These blocks are performed to determine if the patients
pain is facet mediated. Standard therapy for facet mediated neck pain includes radiofrequency
neurotomy (ablation). Most high quality studies for percutaneous cervical medial branch
radiofrequency neurotomy demand at least 70% relief from medial branch blocks of a given
cervical facet before proceeding to radiofrequency neurotomy. Duration of pain relief typically
lasts over a year. Endoscopic rhizotomy is a more recent treatment option for facet mediated
pain. It is typically performed in the lumbar spine. A review of the current peer-reviewed
literature did not yield studies on cervical endoscopic rhizotomy for neck pain, let alone a study
comparing endoscopic rhizotomy versus radiofrequency neurotomy for cervical facet mediated
pain. Du and colleagues performed a comparison study of endoscopic rhizotomy versus
radiofrequency ablation for lumbar facet mediated pain. This study was open label (low quality)
and both methods demonstrated significant benefit of pain relief from baseline. The endoscopic
rhizotomy had slightly better pain relief when compared to the standard radiofrequency
neurotomy group. However, the generalizability of this study to comparing endoscopic rhizotomy
versus radiofrequency neurotomy is not valid or reliable. The article provided by the treating
provider is another low quality study discussing the endoscopic rhizotomy procedure for lumbar
facet mediated pain. Given the lack of supportive peer-reviewed literature, cervical transection
and avulsion of extraspinal nerve is not likely to be more beneficial than any available standard
therapy.
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An 18-year-old female enrollee has requested reimbursement for psychiatric residential treatment from 11/24/14 through 1/08/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions.
The patient was not a danger to herself or others. She participated in her treatment plan. She tolerated her medications without adverse events. She was learning to contain herself and deal with her emotions. Her living environment was supportive, and
compensation in her condition. She had no coexisting medical conditions. She did not require 24 hour nursing | Upheld | Medical Necessity | Summary Reviewer
An 18-year-old female enrollee has requested reimbursement for psychiatric residential treatment from 11/24/14 through 1/08/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the services at issue. The patient was not a danger to herself or others. She participated in her treatment plan. She tolerated her medications without adverse events. She was learning to contain herself and deal with her emotions. Her living environment was supportive, and there was no evidence that returning her to the community would have led to a decompensation in her condition. She had no coexisting medical conditions. She did not require 24 hour nursing and medical supervision and although she required ongoing psychological and psychiatric treatment, this could have occurred at a lower level of care. All told, psychiatric residential treatment from 11/24/14 through 1/08/16 was not medically indicated for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 64-year-old female enrollee has requested reimbursement for gene testing performed on 10/30/17. 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 1
A 64-year-old female enrollee has requested reimbursement for gene testing performed on 10/30/17. 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 FoundationOne is a molecular assay that explores the mutations of an individuals cancer cells, with the hope that it will identify a specific mutation or target that could guide the clinician as to which chemotherapeutic agent would be useful. However, there is a lack of convincing evidence that the assay adds to the decision-making ability or yields a result that is reliably clinically beneficial. A randomized study by Le Tourneau and colleagues did not demonstrate a significant clinical benefit from choosing therapy based on molecular targets versus by the oncologists clinical judgment. Finding a mutation does not guarantee that a drug targeting that mutation will be beneficial. Multiple editorials have questioned the overall approach to treatment using such molecular panels. Therefore, gene testing performed on 10/30/17 was not likely to have been more effective than other available method for evaluating this patient.
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A 37-year-old male enrollee has requested reimbursement and prospective authorization and coverage for assay for calprotectin fecal laboratory performed on 10/28/16 and ongoing. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Crohns disease. | Upheld | Experimental | Summary Reviewer 3
A 37-year-old male enrollee has requested reimbursement and prospective authorization and coverage for assay for calprotectin fecal laboratory performed on 10/28/16 and ongoing. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found that fecal calprotectin has not been definitively established for the management of Crohns disease, and may be redundant with other tests. A meta-analysis of the utility of fecal calprotectin to determine disease activity in adults with inflammatory bowel disease found poor specificity in Crohns disease (Lin, et al). In Crohns disease, studies have demonstrated that calprotectin above 150 ug/g had poor specificity (43%), and therefore poor positive predictive value in predicting relapse (Pardi and Sandborn; Costa, et al). Another meta-analysis of inflammatory bowel disease markers reported that the relatively poor specificity of fecal calprotectin in Crohns disease is a concern, as a false positive test could lead to treatment of a patient without endoscopically active disease (Mosli, et al). Use of calprotectin levels to guide therapy has not definitively been shown in controlled studies to improve clinical outcomes in patients with Crohns disease. Therefore, assay for calprotectin fecal laboratory performed on 10/28/16 and ongoing was not and is 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 and is 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 38-year-old male enrollee has requested authorization and coverage for cervical disc prosthesis. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition.
This patient presents with persistent severe neck pain radiating into the left upper extremity consistent with a C6 radiculopathy. His symptoms | Overturned | Experimental | Summary Reviewer 1
A 38-year-old male enrollee has requested authorization and coverage for cervical disc prosthesis. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found the current medical evidence supports the requested services in this clinical setting. Davis and colleagues performed a prospective, randomized, controlled multicenter clinical trial on two-level symptomatic degenerative disc disease. Their findings supported the use of cervical arthroplasty at two contiguous levels and demonstrated advantages over two-level anterior cervical discectomy and fusion. This patient presents with persistent severe neck pain radiating into the left upper extremity consistent with a C6 radiculopathy. His symptoms are consistent with imaging and electrodiagnostic evidence of radiculopathy at C5-6 and C6-7 with plausible neural compromise. The use of two-level artificial disc replacement will allow for motion preservation in this case. All told, the requested cervical disc prosthesis is likely to be superior over other treatment options. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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The parent of an eight-year-old male enrollee has requested reimbursement and prospective authorization and coverage for applied behavioral analysis (ABA) therapy at the frequency of 30 hours per week of H2019, 12 hours per month of H0031 and 12 hours per month of H0032 provided from 7/16/15 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees autism spectrum disorder.
The patient presents with maladaptive behaviors with tantrums and frequent aggression. | Overturned | Medical Necessity | Summary Reviewer
The parent of an eight-year-old male enrollee has requested reimbursement and prospective authorization and coverage for applied behavioral analysis (ABA) therapy at the frequency of 30 hours per week of H2019, 12 hours per month of H0031 and 12 hours per month of H0032 provided from 7/16/15 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees autism spectrum disorder. The physician reviewer found the review of the submitted documentation and relevant literature demonstrates the medical necessity of the services at issue. ABA has been shown in the medical literature to be effective for children with autism spectrum disorders. The review by Reichow and colleagues shows that early intensive behavioral intervention is effective to increase IQ, improve communication and adaptive skills. In this case, there is a lack of evidence submitted for review that demonstrates the patient has made enough progress to support a reduction in services. The patient presents with maladaptive behaviors with tantrums and frequent aggression. As such, 30 hours per week of H2019, 12 hours per month of H0031 and 12 hours per month of H0032 provided from 7/16/15 forward was and is medically necessary for this patient.Therefore, the services at issue were and are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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A 60-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 10/10/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. | Upheld | Experimental | Summary Reviewer 1
A 60-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 10/10/19. 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 had 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. 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 10/10/19 was not likely to have been more beneficial than any available standard therapy.
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A 62-year-old male has requested authorization and coverage for cervical total disc arthroplasty. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees neck pain and radiculopathy of arm.
This patient presents with progressively worsening neck pain with right upper extremity radiculopathy in the C5 distribution.
. Clinical examination findings were consistent with reported imaging evidence of nerve root compression at the C4-C5 level. He was status post C5-C6 anterior cervical discectomy and fusion with adjacent segment disease at the C4-C5 and C6-C7 levels. | Upheld | Experimental | Summary Reviewer 2
A 62-year-old male has requested authorization and coverage for cervical total disc arthroplasty. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees neck pain and radiculopathy of arm. The physician reviewer found the evidence-based medical guidelines and peer-reviewed literature do not support the use of an artificial disc replacement adjacent to a prior anterior cervical discectomy and fusion and in the setting of multilevel degenerative disc disease. This patient presents with progressively worsening neck pain with right upper extremity radiculopathy in the C5 distribution. Functional limitations were documented in activities of daily living and work activities. Detailed evidence of a recent nonoperative treatment protocol trial and failure has been submitted. Clinical examination findings were consistent with reported imaging evidence of nerve root compression at the C4-C5 level. He was status post C5-C6 anterior cervical discectomy and fusion with adjacent segment disease at the C4-C5 and C6-C7 levels. In sum, the requested cervical total disc arthroplasty is not likely to be of greater benefit than other treatment alternatives. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 58-year-old female enrollee has requested authorization and coverage for Ibrance 100 mg. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees breast cancer.
that this patient has hormone receptor positive breast cancer that has metastasized to her bones, nodes, and lung. She has already been treated with an aromatase inhibitor. | Overturned | Experimental | Summary Reviewer 1
A 58-year-old female enrollee has requested authorization and coverage for Ibrance 100 mg. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees breast cancer. The physician reviewer found that this patient has hormone receptor positive breast cancer that has metastasized to her bones, nodes, and lung. She has already been treated with an aromatase inhibitor. Ibrance in combination with Faslodex is considered a standard of care for patients with metastatic hormone positive breast cancer after progression on an aromatase inhibitor as this patient. Ibrance is also supported by the National Comprehensive Cancer Network (NCCN) guidelines as well as U.S. Food and Drug Administration (FDA) approved for this indication. For these reasons, the requested Ibrance 100 mg is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested medication is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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The parent of a 16-year-old female enrollee has requested reimbursement and prospective authorization and coverage for mental health intensive outpatient program services from 5/21/19 forward. The Health Insurer has denied this request and reported that the services at issue were not and are not medically necessary for the treatment of the enrollees behavioral health conditions.
parent stating that she was giving up on parenting the patient in a family therapy session on 6/05/19.
having been in a residential treatment center for 17 months and continuing to decline in functioning since returning home. | Overturned | Medical Necessity | Summary Reviewer
The parent of a 16-year-old female enrollee has requested reimbursement and prospective authorization and coverage for mental health intensive outpatient program services from 5/21/19 forward. The Health Insurer has denied this request and reported that the services at issue were not and are not medically necessary for the treatment of 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 given her reported history of physical abuse and poor social skills. In terms of functional status, the records support a score of 2 based on her history of the suspension from school and conflict in the home environment. In terms of comorbidity, the records support a score of 2 due to poor social skills and emotional expression for her chronological age without current medical illness. With regards to level of stress of the recovery environment, the records support a score of 3 due to the death of her ex-boyfriend prior to the start of treatment and her sisters car accident during treatment, as well as her sisters cannabis use. In terms of level of stress of the recovery environment, the records support a score of 3 due to the parent stating that she was giving up on parenting the patient in a family therapy session on 6/05/19. With regards to resiliency and treatment history, the records support a score of 3 due to having been in a residential treatment center for 17 months and continuing to decline in functioning since returning home. In terms of acceptance and engagement of the patient, the records support a score of 3 since the patient refused to speak in groups after 5/21/19. With regards to acceptance and engagement of the parent, the records support a score of 3 due to the parent stating in family therapy that she was done parenting the patient. Therefore, the patient has a composite score of 21. Mental health intensive outpatient program services were and are appropriate in this clinical setting. Thus, mental health intensive outpatient program services from 5/21/19 forward were and are medically necessary for the treatment of this patient. | 1 |
A 50-year-old male enrollee has requested authorization and coverage for transcatheter insertion of permanent leadless implantable pacemaker. 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 50-year-old male enrollee has requested authorization and coverage for transcatheter insertion of permanent leadless implantable pacemaker. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that the current medical evidence has not established the superior efficacy of the requested services. Leadless pacing systems have utilized a self-contained system that includes both the pulse generator and the electrode within a single unit that is placed into the right ventricle via a transvenous approach. One system is now U.S. Food and Drug Administration (FDA) approved and commercially available. However, placement of a leadless cardiac pacemaker may lead to right ventricle dysfunction and may contribute to worsening tricuspid regurgitation. Longer term follow-up is needed to assess the safety and efficacy of these devices. Therefore, transcatheter insertion of permanent leadless implantable pacemaker is not likely to be more beneficial than any available standard therapy.
| 1 |
The patient is a 64-year-old female who was diagnosed with rectal cancer in 2016. This patient was diagnosed with localized (T3N0M0) squamous cell cancer of the rectum. The patients provider sent a sample tissue for molecular testing which was initiated on 2/28/17. The patient has requested reimbursement for CarisMI profile testing services performed on 3/10/17. The Health Insurer denied this request on the basis that the services at issue were investigational for the evaluation of this patients medical condition.
. This patient has localized (T3N0M0) squamous cell cancer of the rectum. | Upheld | Experimental | Summary Reviewer 2
The patient is a 64-year-old female who was diagnosed with rectal cancer in 2016. This patient was diagnosed with localized (T3N0M0) squamous cell cancer of the rectum. The patients provider sent a sample tissue for molecular testing which was initiated on 2/28/17. The patient has requested reimbursement for CarisMI profile testing services performed on 3/10/17. The Health Insurer denied this request on the basis that the services at issue were investigational for the evaluation of this patients medical condition. In this case, the services at issue were not likely to be more beneficial for the evaluation of the patients medical condition than any available standard therapy. This patient has localized (T3N0M0) squamous cell cancer of the rectum. Expanded genomic profiling panels are not considered standard testing to assist in managing and directing treatment. Standard therapy incudes local therapy, surgery and radiation, with or without chemotherapy. The standard of care for patients diagnosed with squamous cell cancer is targeted therapy hence the extensive genomic panel ordered including immunohistochemistry would not have been indicated in this clinical setting. In addition, next generation panels may prove useful after failure of the standard of care, primarily to help identify new potentially actionable targets and/or for clinical trial purposes. However, obtaining expanded next generation testing at diagnosis is not reflective of the clonal evolution at relapse or disease refractoriness. In sum, the CarisMI profile testing services performed on 3/10/17 were not likely to be more effective than the standard methods of evaluating this patients medical condition. Therefore, for the reasons stated above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
The parent of a 17-year-old female enrollee has requested reimbursement for residential treatment center services provided from 2/20/15 through 11/23/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions.
At the time of admission, the patient had been referred from a wilderness program. She was described as labile, and lacking in insight and coping skills despite over two months in the wilderness program. Although she denied active suicidal or homicidal ideation, the patient was a danger to herself and others based on her emotional dysregulation and acting out behavior. She was labile, easily triggered, and extremely unpredictable. By 4/14/15, she was less labile, | Overturned | Medical Necessity | Summary Reviewer
The parent of a 17-year-old female enrollee has requested reimbursement for residential treatment center services provided from 2/20/15 through 11/23/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found the submitted documentation supports the medical necessity of a portion of the services at issue. At the time of admission, the patient had been referred from a wilderness program. She was described as labile, and lacking in insight and coping skills despite over two months in the wilderness program. Although she denied active suicidal or homicidal ideation, the patient was a danger to herself and others based on her emotional dysregulation and acting out behavior. She was labile, easily triggered, and extremely unpredictable. By 4/14/15, she was less labile, more firmly engaged and appropriate in her interactions in group, individual, and family therapies, and gaining insight into her behavior. At that point, there was not a high likelihood of her requiring acute hospitalization were she not to be in residential treatment. Although the patient required continued intensive treatment in a highly structured environment, she did not necessitate 24-hour supervision at residential level. Although later into the residential stay, she demonstrated rageful outbursts, once she was at what appeared to be this plateau, it would be difficult to predict any future event and keep her at a higher level of care in anticipation of such an event which may or may not occur. All told, residential treatment center services provided from 2/20/15 through 4/14/15 were medically necessary, but not thereafter. Therefore, a portion of the services at issue was medically necessary for treatment of the patients medical condition. The Health Insurers denial should be partially overturned.
| 1 |
A 23-year-old female enrollee has requested reimbursement for Prometheus Anser IFX testing performed on 2/6/14. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees medical condition.
the patient has left sided ulcerative colitis disease and has been maintained on Remicade since August 2013. However, she had incomplete response as documented clinically despite being maintained on Remicade. Hence, in the midst of this course, while on adequate therapy, an IFX test was ordered to | Overturned | Experimental | Summary Reviewer 3
A 23-year-old female enrollee has requested reimbursement for Prometheus Anser IFX testing performed on 2/6/14. 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 that the patient has left sided ulcerative colitis disease and has been maintained on Remicade since August 2013. However, she had incomplete response as documented clinically despite being maintained on Remicade. Hence, in the midst of this course, while on adequate therapy, an IFX test was ordered to check for Remicade that would necessitate considering alternate therapy. Thus, the indication for the IFX test was the patients ulcerative colitis and incomplete response being on adequate treatment with Remicade and ruling out alternate causes complicating this course. In this case, the IFX test was indicated due to the multitude of management options once a patient has no response to Remicade and the fact that Remicade has a wide array of adverse effects, it is important for the treating provider to have a roadmap of the nature of the patients clinical course. Therefore, the Prometheus Anser IFX testing performed on 2/6/14 was likely to be more beneficial for evaluation and treatment of the patients ulcerative colitis 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 60-year-old female enrollee has requested reimbursement for laboratory services provided on 8/15/19. The Health Insurer indicates that the services at issue were investigational for the evaluation of the enrolleeas medical condition. | Overturned | Experimental | Summary Reviewer 2
A 60-year-old female enrollee has requested reimbursement for laboratory services provided on 8/15/19. The Health Insurer indicates that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that individualized molecular tumor profiling holds the promise of enabling personalized selection of molecularly targeted treatment based on the specific genotype identified. The National Comprehensive Cancer Network guidelines recommend tumor molecular testing prior to initiation of therapy for recurrent or persistent ovarian cancer, if not previously done. Testing should include at least BRCA1/2, homologous recombination pathway genes, and microsatellite instability or DNA mismatch repair. Knowing if a patient has a somatic mutation in a BRCA gene helps select maintenance therapy after primary treatment. Molecular profiling is now considered a standard of care in patients with ovarian cancer. Therefore, laboratory services provided on 8/15/19 were likely to have been more beneficial than other available standard therapy.
| 0 |
The parent of a 17-year-old male enrollee has requested reimbursement for residential treatment provided from 4/11/18 forward. 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.
medical records indicate that the patient was not actively suicidal and did not engage in self-harm.
The patient had some issues with level of function due to mental illness and oppositional behaviors but overall showed appropriate daily functioning while in treatment as evidenced by intact activities of daily living,
did not have a history of past medical issues and had some past substance use issues.
The patient was noted to have good relationship with his family and denied current stress at home of any significant nature.
2. The patient reported improved symptom presentation while at the residential treatment center and was participating in therapy programming while on the unit. He was | Upheld | Medical Necessity | Summary Reviewer
The parent of a 17-year-old male enrollee has requested reimbursement for residential treatment provided from 4/11/18 forward. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found that in cases such as this, an evidence-based instrument such as American Academy of Child and Adolescent Psychiatry and the American Association of Community Psychiatrists Child and Adolescent Level of Care Utilization System (CALOCUS) assists in determining the necessary level of care for children. With regards to risk of harm, the records support a score of 1. The medical records indicate that the patient was not actively suicidal and did not engage in self-harm. In terms of functional status, the records support a score of 2. The patient had some issues with level of function due to mental illness and oppositional behaviors but overall showed appropriate daily functioning while in treatment as evidenced by intact activities of daily living, cooperation with treatment and good school performance. With regards to comorbidity, the records support a score of 2. The patient did not have a history of past medical issues and had some past substance use issues. In terms of level of stress of the recovery environment, the records support a score of 2. The patient was noted to have good relationship with his family and denied current stress at home of any significant nature. With regards to level of support of the recovery environment, the records support a score of 2. The patients parents were involved in treatment. In terms of resiliency and treatment history. The records support a score of 2. The patient reported improved symptom presentation while at the residential treatment center and was participating in therapy programming while on the unit. He was not displaying serious or disruptive symptoms. With regards to acceptance and engagement of the patient, the records support a score of 2. The patient participated in therapy and indicated trust in his therapist. In terms of acceptance and engagement of the parent, the records support a score of 2. The parents worked actively and constructively with clinicians on a regular basis. Thus, the patient has a composite score of 15. This score correlates with outpatient services. Therefore, residential treatment from 4/11/18 forward was not and is not medically necessary for the treatment of this patient. | 1 |
A 58-year-old female enrollee has requested authorization and coverage for Ibrance 100 mg. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees breast cancer. | Overturned | Experimental | Summary Reviewer 3
A 58-year-old female enrollee has requested authorization and coverage for Ibrance 100 mg. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees breast cancer. The physician reviewer found that Ibrance inhibits Cyclin-dependent kinases 4 and 6 (CDK4, CDK6), which may account for resistance to endocrine therapy and has been U.S. Food and Drug Administration (FDA) approved for first-line therapy of estrogen receptor (ER) positive, HER2 negative metastatic breast cancer in postmenopausal women in combination with letrozole. Turner and colleagues reported that in the PALOMA-1 trial, 165 patients were randomized to letrozole or letrozole with Ibrance and the latter regimen conferred increased progression-free survival of 20.2 months versus 10.2 months, a finding of high statistical significance. Overall, there is sufficient medical evidence to suggest that Ibrance is appropriate for this patient who has progressed on standard regimens. As such, the requested Ibrance 100 mg 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.
| 1 |
The patient is a 40-year-old female with a history of psychosis, mood instability and diagnosis of bipolar affective disorder. The patient has requested reimbursement for inpatient services provided from 6/25/20 through 7/02/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient.
Although the patient met medical necessity criteria for inpatient level of care upon her initial presentation on 6/11/20, she had stabilized significantly by 6/25/20. As of 6/26/20, she was noted to be well-groomed, her mood was happy, and she had less thought blocking. At this point, she could have been discharged to a lower level of care.
patient had a low risk of harm given lack of suicidality. She did endorse situation passive suicidal ideation upon learning of discharge. With | Upheld | Medical Necessity | Summary Reviewer
The patient is a 40-year-old female with a history of psychosis, mood instability and diagnosis of bipolar affective disorder. The patient has requested reimbursement for inpatient services provided from 6/25/20 through 7/02/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. Although the patient met medical necessity criteria for inpatient level of care upon her initial presentation on 6/11/20, she had stabilized significantly by 6/25/20. As of 6/26/20, she was noted to be well-groomed, her mood was happy, and she had less thought blocking. At this point, she could have been discharged to a lower level of care. 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. In terms of risk of harm, the records support a score of 2. The patient had a low risk of harm given lack of suicidality. She did endorse situation passive suicidal ideation upon learning of discharge. With regard to functional status, the records support a score of 3. The patient was disabled from mental illness and could not work. She had some disturbance in eating and sleeping habits, although they were improving. In terms of comorbidity, the records support a score of 2. The patient had minor medical comorbidity and had no substance abuse problems. With regard to level of stress of the recovery environment, the records support a score of 2. The patientas recovery environment was mildly stressful. She is away from family on the East Coast and more isolated due to COVID-19. Her husband is supportive. In terms of level of support for the recovery environment, the records support a score of 2. The patient had an outpatient psychiatrist and is able to advocate for her needs. With regard to treatment history, the records support a score of 2. The patient has had good response to outpatient treatment in general and her last inpatient hospitalization was 2015. In terms of engagement, the records support a score of 2. While inpatient, the patient had been adherent with treatment plan, including medication. Therefore, the patient has a composite score of 15. Thus, she did not meet criteria for inpatient level of care. All told, inpatient services provided from 6/25/20 through 7/02/20 were not medically necessary for the treatment of this patient.
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A 38-year-old male enrollee has requested authorization and coverage for Praluent 75 mg/mL pen, 75 mg injected subcutaneously once every two weeks. 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.
. He has mild hyperlipidemia while on pravastatin and ezetimibe. | Upheld | Medical Necessity | Summary Reviewer
A 38-year-old male enrollee has requested authorization and coverage for Praluent 75 mg/mL pen, 75 mg injected subcutaneously once every two weeks. 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. In this patients case, there is no documented clinical cardiovascular disease. He has mild hyperlipidemia while on pravastatin and ezetimibe. In this circumstance, treatment with a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor is not medically necessary. Praluent is a PCSK9 inhibitor studied in and approved only for patients with heterozygous familial hypercholesterolemia or for patients with documented clinical atherosclerotic heart disease who require additional lowering of LDL cholesterol. This patient does not fit any of those criteria. There is no documentation to support a history of homozygous familial hypercholesterolemia or heterozygous hypercholesterolemia. PCSK9 inhibitors have not been studied in other patient populations. The current guidelines that are endorsed by several national organizations do not recommend the use of PCSK9 inhibitors in this primary prevention setting. Therefore, Praluent 75 mg/mL pen is not medically necessary for the treatment of this patient. | 1 |
A 42-year-old male enrollee has requested authorization and coverage for radiofrequency neurolysis. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees low back and left lower extremity pain. | Overturned | Experimental | Summary Reviewer 2
A 42-year-old male enrollee has requested authorization and coverage for radiofrequency neurolysis. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees low back and left lower extremity pain. The physician reviewer found that evidence based clinical practice guidelines for performing radiofrequency neurolysis are consistent with the treatment plan following this patients care (Manchikanti, et al). It is important to note that radiofrequency neurolysis is not permanent as the nerves re-grow. Typically, the lesions produce up to one year of pain relief (Choi, et al). Given that this patients provider followed the treatment paradigm for managing this patients care and properly administered medial branch blocks with the previous radiofrequency ablation, the requested repeat radiofrequency ablation is likely to provide this patient with a superior health outcome as compared to standard available treatment options. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
The patient is a 58-year-old male with psoriasis. He has requested authorization and coverage for Otezla 30 mg. 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 male with psoriasis. He has requested authorization and coverage for Otezla 30 mg. 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 based on the psoriasis treatment guidelines put forth by the American Academy of Dermatology- National Psoriasis Foundation, patients who have psoriasis affecting between 3 to 10% (defined as moderate) and greater than 10% (defined as severe) of their body surface area are candidates for phototherapy and systemic medical therapy. There are no step therapy guidelines recommended in this context, and the choice of therapy should be made at the discretion of the treating provider, with attention paid to patient comorbidities. Otezla is U.S. Food and Drug Administration (FDA) approved and indicated for treatment of moderate-to-severe psoriasis and has Level A evidence to support its efficacy. Given that the patient has documented evidence of moderate-to-severe disease combined with the fact that there is documented evidence of effectiveness with starter pack samples, it is medically appropriate to continue this therapy. Therefore, Otezla 30 mg is medically necessary for the treatment of this patient. | 1 |
A 54-year-old female enrollee has requested authorization and coverage for surgery to treat her heart rhythm. 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 paroxysmal (AF) atrial fibrillation.
records provided, this patient had atrial fibrillation that converted to normal sinus rhythm after treatment with Multaq followed by repeat cardioversion. | Overturned | Experimental | Summary Reviewer 1
A 54-year-old female enrollee has requested authorization and coverage for surgery to treat her heart rhythm. 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 paroxysmal (AF) atrial fibrillation. The physician reviewer found that based on the records provided, this patient had atrial fibrillation that converted to normal sinus rhythm after treatment with Multaq followed by repeat cardioversion. There is a lack of documented recurrent atrial fibrillation since that time based on the records provided. Based on the records, atrial fibrillation ablation is not likely to benefit this patient. The patients symptoms persist but her nonspecific symptoms (malaise, fatigue) may not be due to atrial fibrillation. Current guidelines recommend consideration of atrial fibrillation ablation only if the patient has intolerance or recurrent atrial fibrillation in spite of at least one antiarrhythmic medication trial. In this patients case, the requested surgery to treat her heart rhythm is not likely to be more effective than the available standard therapy. Therefore, for the reasons stated 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 57-year-old male insured has requested reimbursement for a gene test (CPT 0047U) provided on
3/10/22. The Health Insurer has denied this request indicating that the services at issue were considered
investigational for the evaluation of the insureds prostate cancer.
records, this patient presented with a history of Gleason 3+3=6 prostate cancer with a PSA
of 7.74 ng/mL. The patient underwent evaluation with Oncotype DX genomic prostate score testing. | Overturned | Experimental | Summary Reviewer 2
A 57-year-old male insured has requested reimbursement for a gene test (CPT 0047U) provided on
3/10/22. The Health Insurer has denied this request indicating that the services at issue were considered
investigational for the evaluation of the insureds prostate cancer. The physician reviewer found that Per
the available records, this patient presented with a history of Gleason 3+3=6 prostate cancer with a PSA
of 7.74 ng/mL. The patient underwent evaluation with Oncotype DX genomic prostate score testing.
Once prostate cancer is diagnosed in a pathologic specimen, risk stratification is performed by analyzing
the grade of tumor and PSA level. Current studies in the peer-reviewed medical literature have
demonstrated that the Oncotype DX Prostate Cancer Assay is beneficial as an addition to standardized
testing in the assessment and treatment planning of patients with prostate cancer (Klein, et al.). The
Oncotype DX is a gene expression analysis of target genes in the biopsy specimen that generates a
genomic prostate score. The Oncotype DX can help guide the most appropriate therapy for patients, as
well as determine which patients will not require treatment with surgery or radiation (Van Den Eeden,
et al.). Overall, the use of prognostic biomarker testing with Oncotype DX has been shown to improve
patient health outcomes (Klein, et al.). Furthermore, NCCN guidelines also support the use of Oncotype
DX to better stratify patients with localized disease (Cullen, et al.). Therefore, the gene test (CPT 0047U)
provided on 3/10/22 was likely to have been more beneficial for the evaluation of the patients medical
condition than any available standard therapy.
| 1 |
A 35-year-old female enrollee has requested reimbursement for colorectal cancer screening
using chromoendoscopy or narrowband imaging optical colonoscopy performed on 1/25/22. The
Health Insurer has denied this request and reported that the services at issue were investigational
for the evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 3
A 35-year-old female enrollee has requested reimbursement for colorectal cancer screening
using chromoendoscopy or narrowband imaging optical colonoscopy performed on 1/25/22. The
Health Insurer has denied this request and reported that the services at issue were investigational
for the evaluation of the enrollees medical condition. The physician reviewer found that the
current medical evidence supports the services at issue in this patients case. Most society
guidelines advocate for high-definition endoscopy with surface chromoendoscopy or
narrowband imaging as the strategy that optimizes dysplasia detection in patients with
inflammatory bowel disease, including ulcerative colitis. The American Society for
Gastrointestinal Endoscopy noted, Recent studies utilizing image-enhanced endoscopy
in inflammatory bowel disease (IBD) surveillance have led to new recommendations by several
societies for optimal identification and management of IBD-related dysplasia. It is now believed
that most neoplasia is endoscopically visible with high-definition and/or image-enhanced
endoscopy (eg, chromoendoscopy). Most dysplasia previously detected during standard white-
light endoscopy (WLE) by random biopsy only and deemed invisible is, in fact, visible by enhanced
imaging. Therefore, colorectal cancer screening using chromoendoscopy or narrowband
imaging optical colonoscopy performed on 1/25/22 was likely to have been more beneficial than
any available standard therapy. | 1 |
A 56-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing
performed on 6/04/21. The Health Insurer has denied this request and reported that the services at
issue were investigational for the evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 1
A 56-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing
performed on 6/04/21. The Health Insurer has denied this request and reported that the services at
issue were investigational for the evaluation of the enrollees medical condition.
The physician reviewer found that the use of gene expression profiling (GEP) testing according to
specific American Joint Committee on Cancer (AJCC) melanoma stage requires further
prospective investigation in large, contemporary datasets of unselected patients. Prognostic GEP
testing to differentiate melanomas at low versus high risk for metastasis should not replace
pathologic staging procedures. Moreover, since there is a low probability of metastasis in stage I
(T1) melanoma and a higher proportion of false-positive results, GEP testing should not guide
clinical decision-making in this subgroup. Therefore, DecisionDx-Melanoma testing performed
on 6/04/21 was not likely to have been more beneficial than any available standard therapy.
| 0 |
A 65-year-old female enrollee has requested reimbursement for Cx Bladder testing performed on 7/02/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
This patient was evaluated for microscopic hematuria with negative cystoscopy. | Upheld | Experimental | Summary Reviewer 3
A 65-year-old female enrollee has requested reimbursement for Cx Bladder testing performed on 7/02/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that there is insufficient support for the services at issue in this clinical setting. Establishment of bladder cancer diagnosis and the evaluation of microscopic hematuria for asymptomatic patients include imaging, cystoscopy and cytology. This patient was evaluated for microscopic hematuria with negative cystoscopy. Therefore, further testing with urine biomarkers was not indicated. At this time, the superior efficacy of the services at issue has not been established. Thus, Cxbladder testing performed on 7/02/18 was not likely to have been more beneficial than other methods of evaluating this patient.
| 1 |
A 63-year-old female enrollee has requested reimbursement for digital breast tomosynthesis provided on 1/21/16. 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 63-year-old female enrollee has requested reimbursement for digital breast tomosynthesis provided on 1/21/16. 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 there is sufficient support for the services at issue in this patients case. According to Skaane and colleagues, the use of mammography plus tomosynthesis in a screening environment resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers. Ciatto and colleagues noted that integrated two-dimensional and three-dimensional mammography improves breast cancer detection and has the potential to reduce false positive recalls. In sum, digital breast tomosynthesis performed on 1/21/16 was likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 0 |
The patient is a 54-year-old male. In a letter dated 2/18/22, the provider reported that the patient
presented with neck, thoracic, and radiating arm pain. The patient has requested reimbursement
for cervical spine MRI provided on 2/21/22. The physician
that the patient is a
54-year-old male. In a letter dated 2/18/22, the provider reported that the patient presented
with neck, thoracic, and radiating arm pain. The patient reported that his symptoms had started
on Sunday morning, necessitating a visit to the emergency room by Monday night. He reported
similar symptoms a year back, which had been treated with acupuncture. The records noted that
computed tomography (CT) of the cervical spine dated 2/14/22 demonstrated diffuse spondylitis
changes. The provider recommended magnetic resonance imaging (MRI) to evaluate for the
possibility of disc disease. An MRI dated 2/21/22 showed severe disc protrusions at both C5-C6
and C6-C7 where it narrowed the central canal to 0.2 cm, with severe stenosis. The patient has
requested reimbursement for cervical spine MRI provided on 2/21/22. The Health Insurer has
denied this request and reported that the service at issue was not medically necessary for the
evaluation of this patient. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 54-year-old male. In a letter dated 2/18/22, the provider reported that the patient
presented with neck, thoracic, and radiating arm pain. The patient has requested reimbursement
for cervical spine MRI provided on 2/21/22. The physician reviewer found that the patient is a
54-year-old male. In a letter dated 2/18/22, the provider reported that the patient presented
with neck, thoracic, and radiating arm pain. The patient reported that his symptoms had started
on Sunday morning, necessitating a visit to the emergency room by Monday night. He reported
similar symptoms a year back, which had been treated with acupuncture. The records noted that
computed tomography (CT) of the cervical spine dated 2/14/22 demonstrated diffuse spondylitis
changes. The provider recommended magnetic resonance imaging (MRI) to evaluate for the
possibility of disc disease. An MRI dated 2/21/22 showed severe disc protrusions at both C5-C6
and C6-C7 where it narrowed the central canal to 0.2 cm, with severe stenosis. The patient has
requested reimbursement for cervical spine MRI provided on 2/21/22. The Health Insurer has
denied this request and reported that the service at issue was not medically necessary for the
evaluation of this patient. This denial is the subject of this appeal and determination. | 1 |
An 18-year-old male enrollee has requested reimbursement for residential treatment services from 1/20/12 through 12/3/12. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition.
The records fail to contain a detailed mental status exam performed on 1/20/12 at UCLA, on the day prior to admission to treatment. At that time, the patient did not have any major concerns noted. He was given a diagnosis of polysubstance abuse and depressive disorder NOS. According to the discharge summary, the reason for referral for further treatment was because the patient showed little insight into his substance abuse. The patient had no problems with his activities of daily living. He was not homicidal or suicidal and was noted to be cooperative. The UCLA | Upheld | Medical Necessity | Summary Reviewer
An 18-year-old male enrollee has requested reimbursement for residential treatment services from 1/20/12 through 12/3/12. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found THE residential treatment services provided from 1/20/12 through 12/3/12 were not medically necessary for treatment of the patients medical condition. The patient does not meet the medical necessity criteria for residential level of care. Despite, being treated at the residential level of care for almost a year, there was a lack of treatment notes to assess the care provided. The records fail to contain a detailed mental status exam performed on 1/20/12 at UCLA, on the day prior to admission to treatment. At that time, the patient did not have any major concerns noted. He was given a diagnosis of polysubstance abuse and depressive disorder NOS. According to the discharge summary, the reason for referral for further treatment was because the patient showed little insight into his substance abuse. The patient had no problems with his activities of daily living. He was not homicidal or suicidal and was noted to be cooperative. The UCLA records also indicate that the patient had not received any type of substance abuse treatment. In this clinical setting, the patient could have been safely and effectively managed at a lower level of care. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 63-year-old female enrollee has requested reimbursement for breast magnetic resonance imaging (MRI) performed on 3/14/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
patient has a strong family history of breast cancer, and it was | Overturned | Experimental | Summary Reviewer 3
A 63-year-old female enrollee has requested reimbursement for breast magnetic resonance imaging (MRI) performed on 3/14/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the current medical evidence supports the services at issue in this clinical setting. According to Warner and colleagues, screening with both MRI and mammography might rule out cancerous lesions better than mammography alone in women who are known or likely to have an inherited predisposition to breast cancer. The literature supports the use of breast MRI for women with higher risk of breast cancer. This patient has a strong family history of breast cancer, and it was appropriate to screen for breast cancer with MRI. Thus, MRI of the breasts performed on 3/14/16 was likely to have been more effective than other modalities. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 42-year-old male enrollee has requested authorization and coverage for an implanted neurostimulator pulse generator system. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees obstructive sleep apnea (OSA). | Upheld | Experimental | Summary Reviewer 2
A 42-year-old male enrollee has requested authorization and coverage for an implanted neurostimulator pulse generator system. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees obstructive sleep apnea (OSA). The physician reviewer found that as noted in the medical literature, OSA is an increasingly prevalent clinical problem with significant effects. CPAP has demonstrated excellent efficacy and low morbidity with long-term adherence rates approaching 50%. Upper airway stimulation tackles the twin goals of improving anatomic and neuromuscular pathology. Woodson and colleagues reported that the STAR trial demonstrated that hypoglossal nerve stimulation led to significant improvements in objective and subjective measurements of the severity of OSA. This trial demonstrated the hypoglossal nerve stimulator to be safe and effective in a small subset of patients with OSA who have failed CPAP, with an AHI median value of 28.2 event per hour, a BMI less than 32, and nonconcentric airway collapse. However with an AHI of 61.1, this patient does not meet the criteria. For these reasons, the requested implanted neurostimulator pulse generator system is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 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 3
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 Based on current guidelines, lung adenocarcinoma should be evaluated for certain molecular abnormalities and mutations that have clinical implications. When this patient developed metastases, the FoundationOne assay was performed which did not reveal any significant mutations. In this case, the FoundationOne assay had already been performed, and this did not indicate any molecular or mutational results that could guide the provider. There is a lack of support additional testing with Guardant360 would have provided additional clinical benefit in this situation. Thus, the blood test (Guardant360 biopsy-free tumor sequencing test) performed on 12/8/17 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 38-year-old female has requested reimbursement for fecal calprotectin testing performed on 11/22/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ulcerative pan-colitis. | Upheld | Experimental | Summary Reviewer 2
A 38-year-old female has requested reimbursement for fecal calprotectin testing performed on 11/22/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ulcerative pan-colitis. The physician reviewer found that persistent disease activity is associated with a poor prognosis in inflammatory bowel disease. Therefore, monitoring of patients with intent to suppress subclinical inflammation has emerged as a reasonable community-standard treatment goal. As endoscopic monitoring is invasive and resource intensive, identification of valid markers of disease activity has been a priority. Calprotectin, when measured in feces, is commonly used in clinical practice to differentiate between non-organic and inflammatory intestinal disorders, especially to identify inflammatory bowel disease. Fecal calprotectin may also be useful to monitor patients with inflammatory bowel disease under treatment and to predict the risk of recurrence of active disease prior to clinical relapse. However, in this patients case, all available data at the time of the disputed service supported disease quiescence off conventional medications, as well as an absence of signs and symptoms attributable to inflammatory bowel disease. The medical evidence does not support the services at issue in this clinical setting. Therefore, fecal calprotectin testing performed on 11/22/17 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 54-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C. | Overturned | Medical Necessity | Summary Reviewer
A 54-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C. The physician reviewer found according to the most recent joint guidelines issued by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, all patients with chronic hepatitis C, regardless of fibrosis, should be treated except those with limited life expectancy less than 12 months due to non-liver-related conditions. The guidelines support Harvoni for treatment-naive patients with hepatitis C, genotype 1 infection. It is advantageous to treat patients before they progress to cirrhosis. Based on evidence of safety and efficacy in the published literature, the requested medication Harvoni is medically indicated for the treatment of this patient. Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
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