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A 62-year-old male enrollee has requested reimbursement for laboratory testing (Fibrotest-Actitest) performed on 8/14/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 1
A 62-year-old male enrollee has requested reimbursement for laboratory testing (Fibrotest-Actitest) performed on 8/14/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found there is sufficient support for the services at issue in this clinical setting. Fibrotest and Actitest permit the noninvasive evaluation of patients with hepatitis C or hepatitis B for the presence of liver fibrosis and liver inflammation, respectively. Fibrotest and Actitest scores, on a scale of 0.0 to 1.0, are assigned a Metavir scale indicating the level of fibrosis or inflammation present. Several prospective studies have confirmed the overall accuracy of the Fibrotest in discriminating advanced from non-advanced fibrosis. All told, laboratory testing performed on 8/14/15 was likely to have been superior over other methods of evaluation. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 0 |
A 29-year-old female enrollee has requested reimbursement for the Anser ADA test provided on 10/13/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ulcerative colitis. | Upheld | Experimental | Summary Reviewer 3
A 29-year-old female enrollee has requested reimbursement for the Anser ADA test provided on 10/13/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ulcerative colitis. The physician reviewer found that monitoring patients on adalimumab with measurement of adalimumab levels and antibodies continues to be an area of intense investigation. In general, adalimumab levels correlate inversely with disease activity. However, the target level of adalimumab necessary to achieve clinical benefit remains unknown. There is a lack of controlled data which have identified the optimal drug level and the issue remains speculative. Although appealing this algorithmic approach has not been validated using prospectively controlled data. Consistent with these findings, the Anser ADA test provided on 10/13/14 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, I have determined 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 47-year-old female enrollee has requested authorization and coverage for Lyrica. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees peripheral neuropathy.
This patient presents with neuropathy with neuropathic pain.
In this case, the patient has tried and failed standard therapies including gabapentin and amitriptyline and has found | Overturned | Medical Necessity | Summary Reviewer
A 47-year-old female enrollee has requested authorization and coverage for Lyrica. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees peripheral neuropathy. The physician reviewer found the submitted documentation establishes the medical necessity of the requested medication. This patient presents with neuropathy with neuropathic pain. It is well-established that diabetic neuropathy is a model for many types of neuropathy. Nearly half of all neuropathies have no clear cause, but for the most part, the pain noted with neuropathy has a final common pathway, and similar response to treatment. There are a number of studies in the medical literature showing Lyrica is effective in a variety of neuropathic pain. Furthermore, Lyrica is widely prescribed by providers for neuropathic pain outside of diabetic peripheral neuropathy. In this case, the patient has tried and failed standard therapies including gabapentin and amitriptyline and has found Lyrica to be the most effective without side effects. As such, Lyrica is medically necessary for treatment of this patients painful peripheral neuropathy. For the reasons provided, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 51-year-old female enrollee has requested reimbursement for Avastin provided on 12/16/14, 1/6/15, 1/27/15, 2/17/15, and 3/10/15. The Health Insurer has denied this request indicating that the medication at issue was not medically necessary for treatment of the enrollees recurrent metastatic breast cancer. The physician reviewer found the patient was diagnosed with metastatic triple negative breast cancer in September 2014. The patient started treatment with Avastin, carboplatin, and Taxol. A scan done in December 2014 and compared to September 2014 revealed a marked response to therapy. The patient had significant side effects with the cytotoxic components of this regimen, which prompted discussion to proceed with single agent | Overturned | Medical Necessity | Summary Reviewer
A 51-year-old female enrollee has requested reimbursement for Avastin provided on 12/16/14, 1/6/15, 1/27/15, 2/17/15, and 3/10/15. The Health Insurer has denied this request indicating that the medication at issue was not medically necessary for treatment of the enrollees recurrent metastatic breast cancer. The physician reviewer found the patient was diagnosed with metastatic triple negative breast cancer in September 2014. The patient started treatment with Avastin, carboplatin, and Taxol. A scan done in December 2014 and compared to September 2014 revealed a marked response to therapy. The patient had significant side effects with the cytotoxic components of this regimen, which prompted discussion to proceed with single agent Avastin. There are adequate studies demonstrating the clinical efficacy of Avastin in this clinical setting. Further, this patients aggressive form of breast cancer demonstrated a very good response to therapy. All told, the Avastin provided on 12/16/14, 1/6/15, 1/27/15, 2/17/15, and 3/10/15 was medically necessary for treatment of this patients medical condition.
| 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.
that the patient has a history of persistent AF and has required cardioversions. She is now on antiarrhythmic drug therapy with dronedarone.
In this patients case, the provider reported that the patient has symptomatic paroxysmal AF despite antiarrhythmic drug therapy. Thus, catheter | Overturned | Experimental | Summary Reviewer 3
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 the patient has a history of persistent AF and has required cardioversions. She is now on antiarrhythmic drug therapy with dronedarone. According to the guidelines endorsed by the American College of Cardiology, American Heart Association and the Heart Rhythm Society, catheter ablation of atrial fibrillation in this patient would be recommended, AF catheter ablation is useful for symptomatic paroxysmal AF refractory or intolerant to at least one class I or III antiarrhythmic medication when a rhythm-control strategy is desired. In this patients case, the provider reported that the patient has symptomatic paroxysmal AF despite antiarrhythmic drug therapy. Thus, catheter ablation of atrial fibrillation was offered. In sum, the requested surgery to treat her heart rhythm is likely to be more effective than the standard options available for the treatment of this patients medical condition. Therefore, for the reasons stated 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 parent of a 17-year-old male enrollee has requested reimbursement for wilderness therapy program provided from 7/11/16 through 9/21/16 and from 11/3/16 through 12/27/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees behavioral health condition. | Upheld | Experimental | Summary Reviewer 3
The parent of a 17-year-old male enrollee has requested reimbursement for wilderness therapy program provided from 7/11/16 through 9/21/16 and from 11/3/16 through 12/27/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees behavioral health condition. The physician reviewer found that the documentation provided does not support the superior efficacy of the wilderness therapy program over the available standard forms of treatment in this clinical setting. There is a lack of robust, evidence based studies to support wilderness therapy programs are superior over the standard, evidence based treatment options to address this patients diagnoses. The progress notes do not indicate that the patient was treated on any regular intervals by a psychiatrist during his stay at the wilderness program. Key treatment goals described by the treatment program appeared vague in nature. Treatment interventions were listed as individual and group therapy as well as various mindfulness activities and clinical evaluation. There were no treatment goals for interventions that could not have occurred in a community based treatment setting. As such, the wilderness therapy program provided from 7/11/16 through 9/21/16 and from 11/3/16 through 12/27/16 was not likely to have been superior over the standard treatment options available for treating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld. | 0 |
A 60-year-old male enrollee has requested reimbursement for repair of anorectal fistula provided on 10/23/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees anal fistula. | Overturned | Experimental | Summary Reviewer 3
A 60-year-old male enrollee has requested reimbursement for repair of anorectal fistula provided on 10/23/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees anal fistula. The physician reviewer found that the American Society of Colon and Rectal Surgeons (ASCRS) has published practice parameters for the management of perianal abscess and fistula-in-ano (Steele, et al). The treatment recommendations for complex fistulas include seton, fistulotomy, fibrin glue, plug, endorectal advancement flap, and ligation of intersphincteric fistula tract. Placement of a seton with or without fistulotomy has a strong recommendation based on moderate evidence. The use of the Gore Bio-A fistula plug has been recently evaluated in recent studies. In the prospective study by Herold and colleagues, 60 patients with transsphincteric fistulas underwent plug placement and the healing rate at one year was 52%. Most importantly, there was no effect on incontinence which can be a side effect of other procedures performed for management of anal fistula such as cutting seton, fistulotomy, or endorectal advancement flap. In the study by Stamos and colleagues, 93 patients with transsphincteric fistulas were treated at 11 colon and rectal centers. The healing rates at six and 12 months were 41% and 49%, respectively. The authors concluded that implantation of a fistula plug is reasonably efficacious treatment for anal fistula, especially given its simplicity and low morbidity. Given that the support in the peer-reviewed literature and ASCRS practice parameters, the anorectal fistula provided on 10/23/15 was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 0 |
A 65-year-old male enrollee has requested reimbursement for polymerase chain reaction (PCR)
testing on 8/10/21. The Health Insurer has denied this request and reported that the service at
issue was investigational for the evaluation of the enrollees severe diarrhea.
, the patient had persistent diarrhea for weeks. A provider letter dated
9/20/22 reported that the testing at issue showed enteropathogenic Escherichia coli (E.coli). | Upheld | Experimental | Summary Reviewer 1
A 65-year-old male enrollee has requested reimbursement for polymerase chain reaction (PCR)
testing on 8/10/21. The Health Insurer has denied this request and reported that the service at
issue was investigational for the evaluation of the enrollees severe diarrhea. The physician
reviewer found that The Infectious Diseases Society of America guidelines for acute diarrhea note
that certain pathogens that can cause protracted diarrhea, and cannot be detected with
commonly used tests, may be found with nucleic acid amplification tests (NAATs). The American
College of Gastroenterology guidelines for the management of acute diarrhea states, Traditional
methods of diagnosis (bacterial culture, microscopy with and without special stains and
immunofluorescence, and antigen testing) fail to reveal the etiology of the majority of cases of
acute diarrheal infection. If available, the use of U.S. Food and Drug Administration (FDA)
approved culture-independent methods of diagnosis can be recommended at least as an adjunct
to traditional methods. PCR testing may be far more sensitive in clinical testing for the detection
of certain pathogens due to a high sensitivity. Beal and colleagues note that a gastrointestinal
PCR test may more accurately diagnose patients with diarrhea, resulting in improved
management. In this case, the patient had persistent diarrhea for weeks. A provider letter dated
9/20/22 reported that the testing at issue showed enteropathogenic Escherichia coli (E.coli). In
this clinical setting, initial gastrointestinal PCR pathogen panel testing was likely to have been
more beneficial for evaluation of the patients diarrhea than any available standard therapy.
Therefore, PCR testing on 8/10/21 was likely to have been more beneficial for the evaluation of
the patients condition than any available standard therapy.
| 1 |
The parent of a 16-year-old male enrollee has requested reimbursement for immunoassay for
analyte other than infectious agent antibody or infectious agent antigen; quantitative, not otherwise
specified and adalimumab on 8/6/21. The Health Insurer has denied this request indicating that the
service and medication at issue were investigational for the treatment of the enrollees ulcerative
colitis.
In this case, the patient had
symptoms of active ulcerative colitis despite being on Humira. | Overturned | Experimental | Summary Reviewer 3
The parent of a 16-year-old male enrollee has requested reimbursement for immunoassay for
analyte other than infectious agent antibody or infectious agent antigen; quantitative, not otherwise
specified and adalimumab on 8/6/21. The Health Insurer has denied this request indicating that the
service and medication at issue were investigational for the treatment of the enrollees ulcerative
colitis. The physician reviewer found that the use of testing for Humira drug levels and anti-Humira
antibody levels is supported by guidelines in this clinical setting. In this case, the patient had
symptoms of active ulcerative colitis despite being on Humira. The American Gastroenterological
Association (AGA) guideline on therapeutic drug monitoring in inflammatory bowel disease
suggests reactive therapeutic drug monitoring to guide treatment changes in adults with active
inflammatory bowel disease treated with anti-TNF agents. The guideline suggests target trough
concentrations of 7.5 mg/mL for adalimumab. Drug concentration and anti-drug antibody levels
should be checked if there is a loss of response to an anti-TNF medication such as Humira,
allowing for a subsequent change in management including a switch within drug classes, assessing
for inflammation, or increasing the dose. The AGA guidelines for the management of ulcerative
colitis also recommend drug level testing, noting that the patient with nonresponse or loss of
response to therapy should be assessed with therapeutic drug monitoring to identify the reason for
lack of response and whether to optimize the existing therapy or to select an alternate therapy. In
this case, given that the patients symptoms that were consistent with active or uncontrolled
ulcerative colitis, he was at risk for complications from ulcerative colitis such as toxic megacolon,
hospitalization, need for surgery, or colonic dysplasia leading to colorectal cancer. In this clinical
setting, testing for Humira drug level and anti-Humira antibody level was appropriate per
guidelines for the assessment of whether the patients Humira dose should be increased or changed
to an alternative therapy. As the guidelines do not recommend any alternative therapy, the testing
at issue was likely to have been more beneficial than a standard approach of changing Humira to
another therapy, which could be ineffective and result in entirely uncontrolled disease and severe
complications such as hospitalization, surgery, and toxic megacolon. Therefore, immunoassay for
analyte other than infectious agent antibody or infectious agent antigen; quantitative, not otherwise
specified, and adalimumab on 8/6/21 was likely to have been more beneficial for treatment of the
patient's condition than any available standard therapy.
| 1 |
A 52-year-old female enrollee has requested reimbursement for the risk of ovarian malignancy algorithm (ROMA) test provided on 6/22/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees irregular menstrual bleeding and ovarian cyst. The physician reviewer found this patient had a cystic ovarian mass that was managed expectantly. A ROMA test was done | Upheld | Experimental | Summary Reviewer 2
A 52-year-old female enrollee has requested reimbursement for the risk of ovarian malignancy algorithm (ROMA) test provided on 6/22/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees irregular menstrual bleeding and ovarian cyst. The physician reviewer found this patient had a cystic ovarian mass that was managed expectantly. A ROMA test was done to further support this treatment plan. No surgery was planned at the time the test was performed. As noted by Ueland and Li, the ROMA test was approved by the U.S. Food and Drug Administration (FDA) in 2011 to further assess the likelihood of malignancy in women who are planning to have surgery for an adnexal mass. There is a very specific indication for the ROMA test. This indication did not exist in this case. Therefore, the ROMA test performed on 6/22/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy, which was expectant management. 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 36-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 11/21/19. 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 36-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 11/21/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that Melanoma is a cancer that is curable in its earliest stages. Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76 - 1.0 mm. Metastases to regional lymph nodes may be amenable to excision, but this suggests a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha. The data on DecisionDx-Melanoma testing has not made it part of routine analysis after sentinel lymph node biopsy. There has also been some lack of consistency between various genes being used as biomarkers. As such, the test is novel, and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. Therefore, DecisionDx-Melanoma testing performed on 11/21/19 was not likely to have been more beneficial than other available standard therapy.
| 0 |
The parent of a seven-year-old male enrollee has requested authorization and coverage for Saizen 8.8 mg cartridge. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees growth hormone deficiency.
and his adult predicted height, based on the bone age and height assessment in March 2015, is approximately 66.5 inches,
his genetic potential. His growth factors are normal, he does not have any known morphological abnormalities of his pituitary gland,
The patient underwent provocative testing with serial GH levels assayed for a period of three hours after the baseline measurement, but it is
the results provided that two separate provocative tests were performed, with serial measurements of GH | Upheld | Medical Necessity | Summary Reviewer
The parent of a seven-year-old male enrollee has requested authorization and coverage for Saizen 8.8 mg cartridge. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees growth hormone deficiency. The physician reviewer found the submitted documentation fails to establish the medical necessity of the requested medication. According to the documentation submitted for review, the patients height is not more than 2 SDS below the mean for age and gender, and his adult predicted height, based on the bone age and height assessment in March 2015, is approximately 66.5 inches, appropriate for his genetic potential. His growth factors are normal, he does not have any known morphological abnormalities of his pituitary gland, and there is no documentation of abnormal growth velocity for age. The delayed bone age is most consistent with a diagnosis of constitutional delay rather than GH deficiency. The patient underwent provocative testing with serial GH levels assayed for a period of three hours after the baseline measurement, but it is not clear from the results provided that two separate provocative tests were performed, with serial measurements of GH levels for 2-3 hours after each test independently. Although the U.S. Food and Drug Administration (FDA) has approved GH therapy for children with intrauterine growth retardation/small for gestational age with failure to catch-up in height, this patients height is not below the 3rd percentile on the growth curve, and thus he would not meet criteria for failure to catch- up in height. In addition, his adult height prediction is not short enough to qualify for GH on the basis of the FDA-approved idiopathic short stature indication. For the reasons provided, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 54-year-old male enrollee has requested authorization and coverage for Sovaldi and Olysio. 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 54-year-old male enrollee has requested authorization and coverage for Sovaldi and Olysio. 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 that according to the recent joint guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), all patients with chronic hepatitis C should be treated except those with limited life expectancy due to nonliver-related conditions. Per the guidelines, patients with cirrhosis are high priority for treatment. After failure of NS5A inhibitors such as Harvoni, AASLD/IDSA guidelines state that patients who are high priority for treatment (such as this patient) should undergo testing for resistance-associated variants and retreatment when possible. When resistance to NS5A inhibitors is present and NS3 resistance is absent, as in this case, the recommended therapy is Sovaldi and Olysio with ribavirin for 24 weeks based on the resistance testing profile (Lawitz, et al; Buti, et al). For these reasons, the requested treatment with Sovaldi and Olysio is supported as medically necessary for the treatment of this patients hepatitis C infection. Therefore, based on the reasons stated above, the requested medications are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 46-year-old male enrollee has requested reimbursement for collagen crosslinking of the cornea including removal of the corneal epithelial performed on 10/18/16 and 11/1/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees bilateral corneal ectasia. | Overturned | Experimental | Summary Reviewer 1
A 46-year-old male enrollee has requested reimbursement for collagen crosslinking of the cornea including removal of the corneal epithelial performed on 10/18/16 and 11/1/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees bilateral corneal ectasia. The physician reviewer found that there is sufficient support for the superior efficacy of the services at issue in this patients case. Collagen crosslinking procedure has been well studied as a treatment option for corneal ectasia and to stabilize vision loss. Based on the patients vision loss and progression, crosslinking was the most appropriate and effective treatment available. The services at issue are not considered experimental. Instead, crosslinking is validated by the medical literature findings. There is a large body of evidence demonstrating that this treatment is safe and effective for post refractive ectasia. This includes recent prospective placebo controlled trials with a large number of patients that demonstrate the effectiveness of stabilizing corneal ectasia and potentially delaying or preventing the need for full thickness corneal transplant. Furthermore, corneal collagen crosslinking for corneal ectasias fulfills an unmet need. There is very few treatment options available to slow or halt disease progression. As such, treatment for this patients condition with collagen crosslinking of the cornea including removal of the corneal epithelial performed on 10/18/16 and 11/1/16 was likely to have been more effective than any other available option for this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 60-year-old male enrollee has requested reimbursement for Xiaflex injections performed from 6/24/15 through 8/21/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition. | Overturned | Medical Necessity | Summary Reviewer
A 60-year-old male enrollee has requested reimbursement for Xiaflex injections performed from 6/24/15 through 8/21/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition. The physician reviewer found the submitted documentation establishes the medical necessity of the services at issue. Xiaflex has been shown to have modest efficacy in clinical trials and is U.S. Food and Drug Administration (FDA) approved for patients with Peyronies disease with at least 30 degrees of curvature and a palpable plaque. Xiaflex is the only FDA approved drug for Peyronies disease and this patient is an appropriate candidate for Xiaflex. Therefore, the Xiaflex injections performed from 6/24/15 through 8/21/15 were medically necessary for treatment of the patients Peyronies disease. For the reasons provided, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 0 |
The parent of a 16-year-old male enrollee has requested reimbursement and prospective authorization and coverage for intensive outpatient program services provided from 6/16/18 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health conditions.
The patient has had deterioration in level of functioning in relationships with peers, adults and family.
2. The patient was noted to have substance use and several psychiatric issues. | Overturned | Medical Necessity | Summary Reviewer
The parent of a 16-year-old male enrollee has requested reimbursement and prospective authorization and coverage for intensive outpatient program services provided from 6/16/18 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found 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) may assist in determining necessary level of care for children. With regards to risk of harm, the records support a score of 1 due to the patients lack of suicidal ideation or behaviors. In terms of functional status, the records support a score of 3. The patient has had deterioration in level of functioning in relationships with peers, adults and family. With regards to comorbidity, the records support a score of 2. The patient was noted to have substance use and several psychiatric issues. In terms of level of stress of the recovery environment, the records support a score of 3. The patient has severe problematic issues with family relationships. In terms of level of support of the recovery environment, the records support a score of 2. The patients family actively participates in treatment. With regards to resiliency and treatment history, the records support a score of 3 due to recent minimal progress in intensive outpatient program treatment. In terms of acceptance and engagement of the patient, the records support a score of 3. The patient participates somewhat in therapy, but appears non-committal. With regards to acceptance and engagement of the parents, the records support a score of 2. The parents work actively and constructively with clinicians. Thus, the patient has a composite score of 19. This score correlates with intensive outpatient program services. Thus, intensive outpatient program services provided from 6/16/18 forward was and is medically necessary for the treatment of 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.
| 1 |
A 43-year-old female enrollee has requested reimbursement for FoundationOne CDx testing performed on 7/16/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 1
A 43-year-old female enrollee has requested reimbursement for FoundationOne CDx testing performed on 7/16/19. 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 use of next generation sequencing (NGS) or molecular profiling is recommended by the National Comprehensive Cancer Network (NCCN) guidelines for patients with endometrial cancer as well as ovarian cancer. Molecular analysis can help classify difficult cases and provide future therapeutic targets. Individualized molecular tumor profiling holds the promise of enabling personalized selection of molecularly targeted treatment based on the specific genotype identified. The NCCN 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. This patient has two synchronous cancers, and the use of next generation sequencing may help solidify a treatment plan for this patient. Therefore, FoundationOne CDx testing performed on 7/16/19 was likely to have been more beneficial than other methods of evaluating this patient.
| 0 |
A 57-year-old female enrollee has requested reimbursement for the gene test performed on 8/12/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees cutaneous melanoma. | Upheld | Experimental | Summary Reviewer 2
A 57-year-old female enrollee has requested reimbursement for the gene test performed on 8/12/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that the services at issue were not likely to be more effective than other methods of evaluating this patient. The clinical utility of the gene expression assay for cutaneous melanoma has yet to be determined. Moreover, the National Comprehensive Cancer Network (NCCN) Guidelines have not recommended this test outside of a clinical study (trial). In this patients case, the gene test performed on 8/12/15 was not likely to be superior to available standard therapy for the evaluation of this patients malignant melanoma. 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 53-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma test performed on 11/06/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. | Upheld | Experimental | Summary Reviewer 2
A 53-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma test performed on 11/06/19. 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. In addition, the GEP on this patient was sent two years after diagnosis, making the information even less informative. Newer prognostic molecular techniques should not replace standard staging procedures. There is a lack of definitive data regarding its use for risk classification in patients with cutaneous melanoma, and this test does not currently have a role in determining which patients are candidates for adjuvant immunotherapy, either as a standard of care or as part of clinical trials. In sum, DecisionDx-Melanoma test performed on 11/06/19 was not likely to have been more beneficial than other methods of evaluating this patient.
| 0 |
A 42-year-old female enrollee has requested reimbursement for gene test FoundationOne (procedure codes 81201, 81210, 81211, 81235, 81270, 81275, 81292, 81295, 81298 and 81321) on 4/6/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees metastatic breast cancer to the liver and bones. | Upheld | Experimental | Summary Reviewer 3
A 42-year-old female enrollee has requested reimbursement for gene test FoundationOne (procedure codes 81201, 81210, 81211, 81235, 81270, 81275, 81292, 81295, 81298 and 81321) on 4/6/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees metastatic breast cancer to the liver and bones. The physician reviewer found that there is some evidence in the medical literature to support the efficacy of the services at issue in this clinical setting. Von Hoff and colleagues conducted a study of 86 patients where the progression-free survival on regimen selected by molecular profiling was compared to progressive free survival on the last chemotherapy regimen. The regimen selected by molecular profiling offered a 27% survival advantage. This trial has very significant results for patients with stage IV tumors. Recent data on breast cancer also supports the use of FoundationOne testing. In this patients case, the results from FoundationOne profiling offers a rational selection of the next regimen. In sum, gene test FoundationOne (procedure codes 81201, 81210, 81211, 81235, 81270, 81275, 81292, 81295, 81298 and 81321) performed on 4/6/16 was likely to have been more efficacious than other methods of evaluating this patient. Therefore, for the reasons stated above, the services at issue were likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 43-year-old female enrollee has requested reimbursement for the breast tomosynthesis provided on 7/11/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition.
In this case, the patient has heterogeneously dense breasts. | Overturned | Experimental | Summary Reviewer 3
A 43-year-old female enrollee has requested reimbursement for the breast tomosynthesis provided on 7/11/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that the breast tomosynthesis performed on 7/11/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Tomosynthesis is a technique that was developed as a problem solving adjunct to routine mammography. Patients who have dense breasts benefit most from breast tomosynthesis which has the ability to separate out the overlapping structures with the possibility of demonstrating an otherwise occult tumor. In this case, the patient has heterogeneously dense breasts. It is specifically those patients who have dense breasts that can benefit most from tomosynthesis. All told, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 47-year-old male enrollee has requested authorization and coverage for endovenous vein ablation (CPT code 36478). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees varicose veins.
. This patient was diagnosed with CEAP class 2, with no deep vein thrombosis, and no palpable pulses. | Upheld | Experimental | Summary Reviewer 2
A 47-year-old male enrollee has requested authorization and coverage for endovenous vein ablation (CPT code 36478). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees varicose veins. The physician reviewer found that current Society for Vascular Surgery (SVS) and American Venous Forum (AVF) guidelines note the following recommendation, We recommend compression therapy as the primary treatment to aid healing of venous ulceration (GRADE 1B). To decrease the recurrence of venous ulcers, we recommend ablation of the incompetent superficial veins in addition to compression therapy (GRADE 1A) We recommend against selective treatment of perforating vein incompetence in patients with simple varicose veins (CEAP class C(2); GRADE 1B), but we suggest treatment of pathologic perforating veins (outward flow duration =500 ms, vein diameter =3.5 mm) located underneath healed or active ulcers (CEAP class C(5)-C(6); GRADE 2B). This patient was diagnosed with CEAP class 2, with no deep vein thrombosis, and no palpable pulses. In sum, endovenous laser vein ablation (CPT code 36478) is not likely to be more beneficial than the other treatment options available for the treatment of this patient.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 42-year-old male enrollee has requested authorization and coverage for Tremfya. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrollees medical condition.
his quality of life. He has tried many treatments. He is currently on a treatment regimen that is beneficial. | Overturned | Experimental | Summary Reviewer 3
A 42-year-old male enrollee has requested authorization and coverage for Tremfya. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrollees medical condition. The physician reviewer found that this patient has severe and refractory disease that severely impacts his quality of life. He has tried many treatments. He is currently on a treatment regimen that is beneficial. The practice of prescribing patients with psoriasis two medications is commonly done and often yields better outcome than monotherapy. Both treatments have been approved by the U.S. Food and Drug Administration (FDA) for the treatment of psoriasis. According to the most recent guidelines published by the American Academy of Dermatology, there is no contraindication to using two FDA approved psoriasis medications together. A randomized controlled trial with the two agents is impractical. There is sufficient support for the requested medication in this clinical setting. Thus, Tremfya is likely to be more effective than other treatment options.
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A 42-year-old male enrollee has requested authorization and coverage for lumbar total disc arthroplasty (artificial disc). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees low back pain. | Upheld | Experimental | Summary Reviewer 3
A 42-year-old male enrollee has requested authorization and coverage for lumbar total disc arthroplasty (artificial disc). 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 the current medical evidence does not support the requested services in this clinical setting. The long-term safety and efficacy of total disc arthroplasty has not been established. There is the possibility of long-term complications of implantation of metal and metal methyl methacrylate devices in the spine. Additionally, the studies to date do not adequately delineate the problem of component wear. Van Den Eerenbeemt and colleagues noted that high-quality randomized controlled trials with relevant control groups and long-term follow-up are needed to evaluate the safety and efficacy of total disc replacement. In sum, the requested lumbar total disc arthroplasty (artificial disc) is not likely to be superior over other available options. Accordingly, 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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patient is a 64-year-old female with a history of uterine serous carcinoma. The records reflect
that the patient experienced abnormal vaginal bleeding in April 2022. The patient underwent a
total laparoscopic hysterectomy, bilateral salpingo-oophorectomy, bilateral pelvic sentinel
lymphadenectomy, bilateral common iliac and para-aortic lymph node sampling and cystoscopy.
The Health Insurer has denied the inpatient services from 8/11/22 through 8/12/22 as not medically | Upheld | Medical Necessity | Summary
The patient is a 64-year-old female with a history of uterine serous carcinoma. The records reflect
that the patient experienced abnormal vaginal bleeding in April 2022. The patient underwent a
total laparoscopic hysterectomy, bilateral salpingo-oophorectomy, bilateral pelvic sentinel
lymphadenectomy, bilateral common iliac and para-aortic lymph node sampling and cystoscopy.
The Health Insurer has denied the inpatient services from 8/11/22 through 8/12/22 as not medically
necessary for the treatment of the patients medical condition. This denial is the subject of this
appeal and determination. The physician reviewer found that this patient underwent a minimally
invasive surgical procedure for the treatment of uterine cancer. According to the medical
documentation, the surgical procedure was uncomplicated and performed without difficulty. There
is an abundance of evidence in the medical literature that supports the feasibility and safety of
same-day discharge in patients receiving minimally invasive hysterectomy for both benign and
cancer diagnoses. Therefore, the inpatient services from 8/11/22 through 8/12/22 were not
medically necessary for the treatment of this patient.
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A 38-year-old female enrollee has requested authorization and coverage for Tymlos. The Heath Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. | Upheld | Medical Necessity | Summary Reviewer
A 38-year-old female enrollee has requested authorization and coverage for Tymlos. The Heath 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 pregnancy affects bone turnover and mass significantly, but pregnancy-associated osteoporosis is a rare and heterogeneous condition. In a premenopausal woman with osteoporosis, bone mass may be improved by sufficient intake of calcium and vitamin D in addition to increased physical activity. In patients who require pharmacological treatment, teriparatide is the best treatment. The half-life of teriparatide is an hour, which is much shorter than that of bisphosphonates, making it safe for fertile women. Teriparatide can be a therapeutic option for the treatment of pregnancy-associated osteoporosis. There are pharmacological therapy modalities that can be used in pregnancy and lactation induced osteoporosis. Bisphosphonates are effective, but there are some concerns that they accumulate in bone and may expose fetus in subsequent pregnancies. Tymlos is a human parathyroid hormone related peptide analog indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture. Tymlos is not indicated for use in females of reproductive potential. There is a lack of human data regarding Tymlos use in pregnant women to inform drug associated risks. There is a paucity of data on the use of Tymlos in premenopausal women or pregnancy induced osteoporosis. There are articles and case studies reporting successful use of teriparatide in cases of premenopausal pregnancy induced osteoporosis in women who wish to consider additional pregnancies, like in this case. The records do not indicate why the decision was made to change from teriparatide to Tymlos. Therefore, Tymlos (abaloparatide) is not medically necessary for the treatment of this patient.
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A 28-year-old female enrollee has requested reimbursement for computer-aided detection performed on 4/20/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who has BRCA2 gene mutation. | Overturned | Experimental | Summary Reviewer 1
A 28-year-old female enrollee has requested reimbursement for computer-aided detection performed on 4/20/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who has BRCA2 gene mutation. The physician reviewer found that there is sufficient support for the services at issue in this patients case. In young females, breast tissue is almost always mammographically dense, which limits the utility of mammography. MRI is the procedure of choice for annual screening in these patients due to the high sensitivity of the test for breast cancer. Mammography also is of use beginning at age 30, and annual examination with both modalities is recommended at that age. Per the medical evidence, computer-aided detection performed on 4/20/18 was likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 52-year-old female enrollee has requested authorization and coverage for the Intracept
procedure. The Health Insurer has denied this request and reported that the requested medication
is investigational for the treatment of the enrollees low back pain. The Health Insurer indicated
that the requested service is investigational for the treatment of the enrollees medical condition.
Therefore, the Health Insurer has denied coverage for the requested service. The physician reviewer
found that the patient is a 52-year-old female who presented with low back pain. In notes dated
8/23/22, the patient rated her pain at a five to ten out of ten, describing it as sharp, dull, aching,
and stabbing, with symptoms radiating to the right leg, hip, and buttock, along with associated
numbness and tingling in the right leg. An examination revealed intact strength, sensation, and
reflexes. A straight leg raise was negative, and Flexion Abduction External Rotation (FABER) and
Flexion Abduction Internal Rotation (FADIR) were mildly positive bilaterally. Greater trochanters
and sacroiliac joints are tender bilaterally. | Upheld | Experimental | Summary Reviewer 1
A 52-year-old female enrollee has requested authorization and coverage for the Intracept
procedure. The Health Insurer has denied this request and reported that the requested medication
is investigational for the treatment of the enrollees low back pain. The Health Insurer indicated
that the requested service is investigational for the treatment of the enrollees medical condition.
Therefore, the Health Insurer has denied coverage for the requested service. The physician reviewer
found that the patient is a 52-year-old female who presented with low back pain. In notes dated
8/23/22, the patient rated her pain at a five to ten out of ten, describing it as sharp, dull, aching,
and stabbing, with symptoms radiating to the right leg, hip, and buttock, along with associated
numbness and tingling in the right leg. An examination revealed intact strength, sensation, and
reflexes. A straight leg raise was negative, and Flexion Abduction External Rotation (FABER) and
Flexion Abduction Internal Rotation (FADIR) were mildly positive bilaterally. Greater trochanters
and sacroiliac joints are tender bilaterally. The U.S. Food and Drug Administration states, The
Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with
radiofrequency generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae
for the relief of chronic low back pain of at least six months duration that has not responded to at
least six months of conservative care, and is also accompanied by features consistent with Type 1
or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes,
disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow,
hypointensive signals (Type 1 Modic change), and changes to the vertebral body marrow including
replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change).
In this case, an MRI report dated 7/1/22 does not corroborate any Modic changes at the L3 level,
as mentioned by the provider. Conger and colleagues report, Evidence that suggests this
procedure is effective in reducing pain and disability in patients with chronic low back pain who
are selected based on type 1 or 2 Modic changes. DeVivo and colleagues report, Selection of
patients is based on a multidisciplinary approach including both conventional diagnostic radiology
and nuclear medicine imaging. In this case, the records did not include any nuclear medicine
imaging to support diagnostic radiology. There are multiple plausible pathologic sources of
significant pain generation. Tieppo Francio and colleagues note, Finding the source of chronic
axial low back pain is clinically challenging, and often 80% of diagnoses are described as non-
specific low back pain, and in only 20% of cases, an anatomical source can be attributed. In this
case, the patients noted back pain, pain-aggravating factors such as sitting, standing, bending, and
twisting, pain-relieving factors such as walking and laying down, and intact neurologic
examination documented in notes dated 8/23/22 were non-specific to any pathologic entities. In
the case of multiple plausible sites of symptomatic pathology, standard therapies may include
repeat physical therapy, epidural steroid injections, and medications. Rivera notes, Lumbar
epidural steroid injections under fluoroscopic guidance are used very commonly for the treatment
of low back and lower extremity radicular pain. These procedures have been shown to be effective
for pain relief in the short term and are relatively safe. Knezevic and colleagues report, Low
back pain covers a spectrum of different types of pain (e.g. nociceptive, neuropathic and
nociplastic, or non-specific) that frequently overlap. The elements comprising the lumbar spine
(e.g. soft tissue, vertebrae, zygapophyseal and sacroiliac joints, intervertebral discs, and
neurovascular structures) are prone to different stressors, and each of these, alone or in
combination, can contribute to low back pain. The authors further note, To a large extent, therapy depends on pain classification, and usually starts with self-care and pharmacotherapy in
combination with non-pharmacological methods, such as physical therapies and psychological
treatments in appropriate patients. For refractory low back pain, a wide range of non-surgical (e.g.
epidural steroid injections and spinal cord stimulation for neuropathic pain, and radiofrequency
ablation and intra-articular steroid injections for mechanical pain) and surgical (e.g. decompression
for neuropathic pain, disc replacement, and fusion for mechanical causes) treatment options are
available in carefully selected patients. Therefore, the Intracept procedure is not likely to be more
beneficial for treatment of the patients condition than any available standard therapy.
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A 52-year-old male enrollee has requested authorization and coverage for CPT 43284 (magnetic sphincter augmentation). 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 1
A 52-year-old male enrollee has requested authorization and coverage for CPT 43284 (magnetic sphincter augmentation). 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 magnetic sphincter augmentation (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 aseverea 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 There are 29 reports of LINX erosion through the esophagus in the publicly-accessible FDA Adverse Events database, among other adverse events. The currently available peer-reviewed literature does not definitively support the conclusion that LINX is more likely to be beneficial in this case than standard treatment. LINX has significant potential adverse effects and can be associated with poor outcomes. Therefore, CPT 43284 (magnetic sphincter augmentation) is not likely to be more beneficial than any available standard therapy.
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A 46-year-old male enrollee has requested reimbursement and prospective authorization and coverage for Januvia. The Health Insurer has denied this request indicating that the medication at issue was not and is not medically necessary for treatment of the enrollees diabetes. | Overturned | Medical Necessity | Summary Reviewer
A 46-year-old male enrollee has requested reimbursement and prospective authorization and coverage for Januvia. The Health Insurer has denied this request indicating that the medication at issue was not and is not medically necessary for treatment of the enrollees diabetes. The physician reviewer found that Diabetes is a progressive disease, which typically manifests with increasing loss of glycemic control over time in spite of lifestyle and pharmacologic intervention. Although type 2 diabetes is initially due to insulin resistance, studies have shown that patients with this disease also may have a decline in pancreatic beta cell function, which begins as early as 12 years before diagnosis and continues throughout the disease process (Fonseca). New diabetic medications have been developed which are being used earlier in the course of treatment of diabetes. Among these is the DPP4 inhibitors (DPP4i), such as Januvia, which are a class of newly developed antidiabetic drugs which help lower blood glucose levels and may help preserve pancreatic beta cell function (Godinho, et al). In addition, the 2015 comprehensive management algorithm published by the American Association of Clinical Endocrinologists (AACE) recommends that this medication may be used as either monotherapy or in combination therapy for treatment of diabetes (Garber, et al). While this patient responded well to combination therapy of Januvia and metformin, his glycemic control worsened after switching to another medical regimen. Improper management of diabetes could increase a patients risk of developing complications from diabetes and possibly lead to a more rapid progression of diabetes. Consistent with these findings, treatment with Januvia was and is medically necessary for treatment of this patients diabetes. Based on the foregoing discussion, the medication at issue was and is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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patient is a 96-year-old male with a history of ongoing eczema. The patient has requested authorization and coverage for Dupixent 300 mg. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient.
This patient has moderate-to-severe disease that is interfering with his daily activities, like sleep. He has tried many traditional treatments without success. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 96-year-old male with a history of ongoing eczema. The patient has requested authorization and coverage for Dupixent 300 mg. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The physician reviewer found that Dupixent is used for chronic eczema that is moderate to severe. This patient has moderate-to-severe disease that is interfering with his daily activities, like sleep. He has tried many traditional treatments without success. Dupilumab (Dupixent) is safe, effective, and U.S. Food and Drug Administration (FDA) approved for the treatment of moderate-to-severe atopic eczema. It would be medically reasonable and necessary for this patient to use Dupixent to treat his refractory moderate-to-severe eczema. There are multiple trials showing its efficacy and safety. Therefore, Dupixent 300 mg is medically necessary for the treatment of this patient.
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patient is a 56-year-old female who presented in 2012 with breast
cancer. The patient has requested authorization and coverage for
stereotactic body radiation therapy. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 56-year-old female who presented in 2012 with breast
cancer. The patient has requested authorization and coverage for
stereotactic body radiation therapy. The physician reviewer found the
submitted documentation fails to demonstrate the medical necessity of the
requested services. The use of stereotactic body radiotherapy in
metastatic breast cancer is not standard of care. Stereotactic body
radiotherapy allows for the use of a high dose of radiation to a small
volume and is generally utilized in the curative setting. This patient
requires palliative radiotherapy, and the standard technique is typically
with 3D conformal radiotherapy. There is a lack of meaningful clinical
data to support the routine use of stereotactic body radiotherapy in
patients with widespread metastases. Furthermore, there is a lack of
published randomized trials that support the use of stereotactic body
radiotherapy over standard treatment. The current National Comprehensive
Cancer Network guidelines also do not support the routine use of
stereotactic body radiotherapy in treatment of breast cancer. In this
case, the provider noted the plan to use stereotactic body radiotherapy
to target a single lung metastasis that is not responding to systemic
therapy. In this setting, there is no proven benefit of stereotactic body
radiation therapy to the one progressive lesion. Therefore, the requested
stereotactic body radiation therapy is not medically necessary for the
treatment of this patient. | 1 |
The patient is a nine-year-old male. The patients parent has requested reimbursement for speech therapy provided from 1/12/19 through 10/19/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient.
that the patient has autism spectrum disorder and attention deficit/hyperactivity disorder, predominantly inattentive subtype. He has significant impairment in the appropriate social use of pragmatic language, which is causing difficulty with social interaction with his peers and adults. His language difficulties are also adversely affecting his school performance. The patient will be at significant risk of anxiety and depression as a result of his language impairment. | Overturned | Medical Necessity | Summary Reviewer
The patient is a nine-year-old male. The patients parent has requested reimbursement for speech therapy provided from 1/12/19 through 10/19/19. 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 patient has autism spectrum disorder and attention deficit/hyperactivity disorder, predominantly inattentive subtype. He has significant impairment in the appropriate social use of pragmatic language, which is causing difficulty with social interaction with his peers and adults. His language difficulties are also adversely affecting his school performance. The patient will be at significant risk of anxiety and depression as a result of his language impairment. Maiano and colleagues estimated that 44% of children with autism are bullied at school. This is frequently due to their difficulty interacting appropriately with others. Helland and Helland recommended that the substantial influence of pragmatic language abilities on social function and in resolving interpersonal conflicts with peers needs to be considered in children with autism, and that further development of therapy plans and interventions targeting pragmatics is strongly needed. There is sufficient support for the services at issue in this clinical setting. Therefore, speech therapy provided from 1/12/19 through 10/19/19 was medically necessary for the treatment of this patient. | 1 |
A 34-year-old male has requested reimbursement for polymerase chain reaction (PCR) testing performed on 8/03/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
of infectious mononucleosis. The evaluation on 8/03/17 suggests a viral pharyngitis. He had already been given an extended spectrum penicillin antibiotic. The rash was not suggestive of mononucleosis. | Upheld | Experimental | Summary Reviewer 3
A 34-year-old male has requested reimbursement for polymerase chain reaction (PCR) testing performed on 8/03/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that the patient did not have clinical evidence of infectious mononucleosis. The evaluation on 8/03/17 suggests a viral pharyngitis. He had already been given an extended spectrum penicillin antibiotic. The rash was not suggestive of mononucleosis. This disease may cause a macular rash, but it does not produce a pustular eruption. Importantly, the patient did not have a lymphocytosis. Additionally, PCR testing on blood is not a test used to make a diagnosis of monoucleosis. The tests sole use is in highly immunocompromised individuals who may have a viremic illness. Thus, PCR testing performed on 8/03/17 was not likely to have been more efficacious than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were 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 the Prolia injection performed on 11/21/14. The Health Insurer has denied this request indicating that the services at issue were investigational for treatment of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 1
A 63-year-old female enrollee has requested reimbursement for the Prolia injection performed on 11/21/14. The Health Insurer has denied this request indicating that the services at issue were investigational for treatment of the enrollees medical condition. The physician reviewer found the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Denosumab (Prolia) is a fully human monoclonal antibody which has been approved for the treatment of osteoporosis, treatment-induced bone loss, bone metastases, multiple myeloma, and giant cell tumor of bone (McClung, et al). Prolia is U.S. Food and Drug Administration (FDA) approved for the treatment of postmenopausal osteoporosis in women at a high or increased risk of fracture who have failed or are intolerant to other available osteoporosis therapy. Fractures are the most dangerous aspect of osteoporosis, which can lead to acute and chronic pain (Old and Calvert). In this case, the patient failed bisphosphonate therapy (Actonel). As such, the Prolia injection provided on 11/21/14 was likely to be a more beneficial treatment than standard medical therapy in this clinical setting. Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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The parent of a 17-year-old female enrollee has requested authorization and coverage for external ambulatory insulin delivery system (Omnipod). The Health Insurer has denied this request indicating that the requested device is not medically necessary for treatment of the enrollees diabetes.
. This patient has had malfunctioning of her Medtronic pump and adverse reactions to the site insertions while engaged in competitive swimming. She is able to successfully employ insulin pump therapy to control her diabetes and has had excellent adherence to diabetes management tasks, but she requires a different type of pump due to her active lifestyle. | Overturned | Medical Necessity | Summary Reviewer
The parent of a 17-year-old female enrollee has requested authorization and coverage for external ambulatory insulin delivery system (Omnipod). The Health Insurer has denied this request indicating that the requested device is not medically necessary for treatment of the enrollees diabetes. The physician reviewer found that transition to the Omnipod pump is medically necessary for this patient. This patient has had malfunctioning of her Medtronic pump and adverse reactions to the site insertions while engaged in competitive swimming. She is able to successfully employ insulin pump therapy to control her diabetes and has had excellent adherence to diabetes management tasks, but she requires a different type of pump due to her active lifestyle. Treatment with the Omnipod insulin management system has been found to be associated with clinically meaningful and statistically significant improvement in glycemic control, reduction in daily insulin requirement and reduction in the frequency and severity of hypoglycemic episodes analogous to the Medtronic pump. The medical evidence supports the requested device in this patients case. All told, the requested external ambulatory insulin delivery system (Omnipod) is medically necessary for the treatment of this patient. Therefore, the requested device is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned. | 1 |
A 61-year-old female enrollee has requested reimbursement for laboratory testing performed on
11/29/19. 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 61-year-old female enrollee has requested reimbursement for laboratory testing performed on
11/29/19. 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 molecular testing has become a vital part of testing in non-small cell lung cancer and
can help direct treatment decisions. The most extensive data on molecular testing is on tissue
samples from either a primary lung tumor or metastatic tumor. Both National Comprehensive
Cancer Network and American Society of Clinical Oncology guidelines do not recommend the
regular use of cell-free DNA tests, such as Guardant 360, in lieu of a tissue diagnosis. False
negative rates can be significant, and there is a lack of published guidelines on the standards for
analytical performance. In the setting where insufficient tissue can be obtained, circulating tumor
DNA testing can be considered. However, in this case, tissue was obtained and molecular testing
was able to be performed. Therefore, laboratory testing performed on 11/29/19 was not likely
to have been more beneficial than any available standard therapy.
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patient is a 28-year-old female with a history of severe persistent eosinophilic asthma. She has requested authorization and coverage for Fasenra Pen.
documentation indicates that the patient has severe persistent asthma and has required several courses of oral steroids for uncontrolled asthma symptoms. The patient has been using Symbicort and Breztri, and she continues to have episodes of asthma flare-ups. Her blood eosinophil count in end of August 2021 was greater than 150 cell/ml. The provider attested that she will continue to use inhaled corticosteroids Symbicort in conjunction with Fasenra therapy. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 28-year-old female with a history of severe persistent eosinophilic asthma. She has requested authorization and coverage for Fasenra Pen. The physician reviewer found that Benralizumab (Fasenra) is a cytotoxic monoclonal antibody directed against IL-5 receptor alpha that is approved by the U.S. Food and Drug Administration (FDA) as add-on therapy in patients with severe asthma and an eosinophilic phenotype. The submitted documentation indicates that the patient has severe persistent asthma and has required several courses of oral steroids for uncontrolled asthma symptoms. The patient has been using Symbicort and Breztri, and she continues to have episodes of asthma flare-ups. Her blood eosinophil count in end of August 2021 was greater than 150 cell/ml. The provider attested that she will continue to use inhaled corticosteroids Symbicort in conjunction with Fasenra therapy. There is sufficient support for the requested medication in this clinical setting. Therefore, the requested Fasenra Pen is medically necessary for the treatment of this patient. | 1 |
A 64-year-old male enrollee has requested reimbursement for electrical stimulation device used for cancer treatment on 1/24/19, 2/24/19 and 3/24/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. | Overturned | Medical Necessity | Summary Reviewer
A 64-year-old male enrollee has requested reimbursement for electrical stimulation device used for cancer treatment on 1/24/19, 2/24/19 and 3/24/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that in 2011, the U.S. Food and Drug Administration (FDA) approved a portable medical device that generates low-intensity alternating electric fields, also known as Optune, for the treatment of recurrent glioblastoma. Approval was based on results of a clinical trial that randomized 237 patients to tumor treating fields (TTF) or chemotherapy. Similar survival was observed in the two arms, and TTF therapy was associated with lower toxicity and improved quality of life. Consensus-based guidelines published by the National Comprehensive Cancer Network (NCCN) include alternating electric field therapy as a treatment option for patients with recurrent glioblastoma as adjuvant therapy in combination with temozolomide. Therefore, electrical stimulation device used for cancer treatment provided on 1/24/19, 2/24/19 and 3/24/19 was medically necessary for the treatment of this patient. | 0 |
patient is a 50-year-old female who presented to her provider on 11/1/22 with an
exacerbation of chronic pain in the left shoulder. The patient has requested authorization and
coverage for prescription tramadol HCL tablet 50 mg.
In this case, the patient has chronic pain in her shoulder due to a rotator
cuff tear. Her previous medications include the antidepressant trazadone and buspirone for the
treatment of anxiety disorder. She has also been on long-term treatment with high-dose
ibuprofen, which | Overturned | Medical Necessity | Summary
The patient is a 50-year-old female who presented to her provider on 11/1/22 with an
exacerbation of chronic pain in the left shoulder. The patient has requested authorization and
coverage for prescription tramadol HCL tablet 50 mg. The physician reviewer found that at issue
is whether prescription tramadol HCL tablet 50 mg is medically necessary for the treatment of
this patient. The submitted documentation supports the medical necessity of a portion of the
requested medication. In this case, the patient has chronic pain in her shoulder due to a rotator
cuff tear. Her previous medications include the antidepressant trazadone and buspirone for the
treatment of anxiety disorder. She has also been on long-term treatment with high-dose
ibuprofen, which may be associated with significant gastrointestinal complications including
ulcers and bleeding. The Centers for Disease Control and Prevention (CDC) guideline on chronic
pain includes the recommendation to limit opioids for acute pain in most cases to three to seven
days based on evidence showing an association between use of opioids for acute pain and long-
term use. In this case, given that the patient has tried nonsteroidal anti-inflammatory drugs
(NSAIDs), antidepressants, anticonvulsants, and acetaminophen, a prescription for seven days of
tramadol HCL tablet 50 mg, dosed every six hours, is medically indicated. Therefore, a
prescription for seven days of tramadol HCL tablet 50 mg, 30 pills, is medically necessary for the
treatment of this patient. | 1 |
The patient is a 46-year-old female with a history of left abdominal pain and left hip pain. The patient reported that she has experienced pain on the left side since the spring of 2016. She has been seen by urologist and gynecologist. Physical therapies were prescribed. An orthopedic provider recommended fluoroscopically guided injection into hip joint. The patient reported that her pain was relieved. On 12/22/16 magnetic resonance imaging (MRI) was performed. MRI of the hip noted complex tear anterior left acetabular labrum, full thickness of labral base. The tear was best seen in sagittal fat saturated proton density left hip sequence. On 1/31/17, an operative note indicated that preoperative and postoperative diagnosis was left hip pain, labral tear and impingement. Postoperative diagnosis noted degenerative labral tearing left hip pincer type impingement. Procedure left hip arthroscopic pincer lesion resection and labral debridement were performed. The following were indications for surgery: pain relief response on injection and MRI showing complex labral tear with possible cam type impingement.
mild degenerative joint disease left hip, small area of fissuring and cartilage softening, extensive degenerative labral tearing, pincer lesion between 11 and 12 oclock with no obvious CAM lesion. The patient has requested reimbursement for hip surgery performed on 1/31/17. The Health Insurer has denied this request on the basis that the services at issue were investigational for treatment of this patients medical condition. | Overturned | Experimental | Summary Reviewer 2
The patient is a 46-year-old female with a history of left abdominal pain and left hip pain. The patient reported that she has experienced pain on the left side since the spring of 2016. She has been seen by urologist and gynecologist. Physical therapies were prescribed. An orthopedic provider recommended fluoroscopically guided injection into hip joint. The patient reported that her pain was relieved. On 12/22/16 magnetic resonance imaging (MRI) was performed. MRI of the hip noted complex tear anterior left acetabular labrum, full thickness of labral base. The tear was best seen in sagittal fat saturated proton density left hip sequence. On 1/31/17, an operative note indicated that preoperative and postoperative diagnosis was left hip pain, labral tear and impingement. Postoperative diagnosis noted degenerative labral tearing left hip pincer type impingement. Procedure left hip arthroscopic pincer lesion resection and labral debridement were performed. The following were indications for surgery: pain relief response on injection and MRI showing complex labral tear with possible cam type impingement. The summary of intraoperative findings: mild degenerative joint disease left hip, small area of fissuring and cartilage softening, extensive degenerative labral tearing, pincer lesion between 11 and 12 oclock with no obvious CAM lesion. The patient has requested reimbursement for hip surgery performed on 1/31/17. The Health Insurer has denied this request on the basis that the services at issue were investigational for treatment of this patients medical condition. There is sufficient support for the efficacy of the services at issue in this clinical setting. Femoroacetabular impingement syndrome and its treatment is now well established and the technical requirements are well within the experience of an orthopedic surgeon skilled in arthroscopic techniques. The study published by Ganz and colleagues includes two year follow-up with improved ranges of motion and reduction in pain. This procedure involved dislocation of the hip and because of that there is added potential for morbidity. An extra-articular approach using an arthroscopic technique is reasonable and has been technically well developed. In a study by Espinosa and colleagues, extra-articular surgery with labral refixation was followed in a two year follow-up period with 48% good results, 20% moderate results and 4% poor results. The studies cited are level III and level IV studies. As such, the hip surgery performed on 1/31/17 was likely to have been more effective for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 57-year-old female insured has requested reimbursement for a blood test performed on
3/7/23. The Health Insurer has denied this request indicating that the service at issue was
considered investigational for the evaluation of the insureds rheumatoid arthritis.
that this patient presented with a history of rheumatoid arthritis, for which she
underwent evaluation with a Vectra DA blood test. | Upheld | Experimental | Summary Reviewer 1
A 57-year-old female insured has requested reimbursement for a blood test performed on
3/7/23. The Health Insurer has denied this request indicating that the service at issue was
considered investigational for the evaluation of the insureds rheumatoid arthritis. The physician
reviewer found that this patient presented with a history of rheumatoid arthritis, for which she
underwent evaluation with a Vectra DA blood test. Scoring tools such as the Disease Activity
Score 28 CRP (DAS 28-CRP), the Clinical Disease Activity Index (CDAI), and the Simplified Disease
Activity Index (SDAI) are supported by the medical literature and routinely utilized for the
assessment of rheumatoid arthritis disease activity in both clinical trials and in real clinical
practice settings. There is a lack of medical literature or evidence suggesting that the Vectra DA
test is more effective in establishing the level of rheumatoid arthritis disease activity experienced
by a patient than the standard therapies noted above. For these reasons, the blood test
performed on 3/7/23 was not likely to have been more beneficial for the evaluation of the
patients condition than any available standard therapy.
| 1 |
A 22-year-old female enrollee has requested authorization and coverage for Botox injections. The Health Plan has denied this request indicating that the requested service is not medically necessary for treatment of the enrollees lymphatic malformation. | Overturned | Medical Necessity | Summary Reviewer
A 22-year-old female enrollee has requested authorization and coverage for Botox injections. The Health Plan has denied this request indicating that the requested service is not medically necessary for treatment of the enrollees lymphatic malformation. The physician reviewer found botox injections have been established as medically necessary for treatment of the patients medical condition. The application of Botox to the healthy side of the face in patients with long-standing facial paralysis has been shown to be a minimally invasive technique that improves facial symmetry at rest and during facial motion. In addition, since this patient developed facial paralysis after treatment for a lymphatic malformation, surgery to treat the facial asymmetry would be considered reconstructive. Moreover, treatment with Botox should be considered medically necessary to improve the patients facial asymmetry. All told, Botox injections are medically necessary for treatment of the patients medical condition. Therefore, the requested service is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 40-year-old female enrollee has requested authorization and coverage for breast reduction surgery. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollee, who reported back, neck and shoulder pain.
This patient has large pendulous breasts with shoulder grooving and the classic symptoms for macromastia. | Overturned | Medical Necessity | Summary Reviewer
A 40-year-old female enrollee has requested authorization and coverage for breast reduction surgery. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollee, who reported back, neck and shoulder pain. The physician reviewer found that the submitted documentation supports the medical necessity of the requested services. Symptomatic macromastia is a mechanical problem, and conservative treatments have been shown to be ineffective for this condition. Nonoperative treatments are unlikely to improve her pain. This patient has large pendulous breasts with shoulder grooving and the classic symptoms for macromastia. Breast reduction is the only treatment that is proven in the medical literature to be curative for symptomatic macromastia, and the peer-reviewed literature confirms the benefit of breast reduction surgery for women with upper torso pain due to breast hypertrophy. Thus, breast reduction surgery is medically necessary for the treatment of this patient. Therefore, the requested services are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned. | 1 |
A 65-year-old male has requested reimbursement for gene testing performed on 12/09/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees prostate cancer. | Overturned | Experimental | Summary Reviewer 3
A 65-year-old male has requested reimbursement for gene testing performed on 12/09/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees prostate cancer. The physician reviewer found the most important decision for a patient with prostate cancer is whether to undergo specific cancer treatment, or to pursue active surveillance only. Currently, such a decision often depends on the classification of that mans cancer as to risk of progression. Using this patients pathologic parameters and prostate specific antigen, he would be seen as falling into a low-risk group. Such a patient would seriously consider surveillance only, with no specific cancer treatment. Beyond these clinical features, a variety of genomic assays of the individuals cancer cells have been developed, amongst which is the 17 gene assay, Oncotype DX prostate cancer testing. The medical evidence indicates that such assays are of value in patients with low risk cancer. Thus, gene testing performed on 12/09/15 was likely to have been more effective than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were 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 female has requested reimbursement for Anser IFX Assay testing performed on 10/26/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 3
A 42-year-old female has requested reimbursement for Anser IFX Assay testing performed on 10/26/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the Anser IFX Assay testing was ordered to determine the cause for possible reaction to and loss of response to Remicade. The use of Anser IFX Assay testing to direct subsequent management has not been clinically proven to improve patient clinical outcomes or alter patient management in controlled clinical trials. The presence of antibodies alone does not necessarily result in reaction to or loss of response to infliximab, nor have threshold drug levels been established. Studies have found that anti-infliximab antibodies can be transient, and disappear over time, with many patients who have these antibodies maintaining their response. Based on the clinical literature, the services at issue were not likely to have been superior over other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
A 71-year-old male enrollee has requested reimbursement ablation of the prostate, transrectal high intensity focused ultrasound (HIFU) including imaging guidance performed on 12/20/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee who has a history of prostate cancer. The physician reviewer found that the patient is a 71-year-old male with a history of prostate cancer (Gleason 7, T2c). He had high intensity focused ultrasound (HIFU) and had a rising prostate specific antigen (PSA). The patient has requested reimbursement for ablation of the prostate using transrectal HIFU including imaging guidance performed on 12/20/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for the treatment of the patient who has a history of prostate cancer. | Upheld | Experimental | Summary Reviewer 2
A 71-year-old male enrollee has requested reimbursement ablation of the prostate, transrectal high intensity focused ultrasound (HIFU) including imaging guidance performed on 12/20/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee who has a history of prostate cancer. The physician reviewer found that the patient is a 71-year-old male with a history of prostate cancer (Gleason 7, T2c). He had high intensity focused ultrasound (HIFU) and had a rising prostate specific antigen (PSA). The patient has requested reimbursement for ablation of the prostate using transrectal HIFU including imaging guidance performed on 12/20/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for the treatment of the patient who has a history of prostate cancer. HIFU has been increasingly used for treatment of localized prostate cancer within the last decade. It has the theoretical potential of decreasing gastrointestinal, genitourinary and sexual toxicity. Potential candidates are patients with low to moderate risk prostate cancer. However, the available literature mainly consists of prospective case series and retrospective studies from Europe showing short to intermediate term outcomes for localized prostate cancer. As such, there is a lack of controlled trials available for analysis and very little long term survival data available. Additionally, there is a lack of validated biochemical and surrogate end point for cure. The National Comprehensive Cancer Network guidelines on prostate cancer state the following about focal therapy and HIFU, Other emerging local therapies, such as high intensity focused ultrasound (HIFU) and vascular-targeted photodynamic (VTP) also warrant further study. American Urological Association/American Society for Radiation Oncology/Society of Urologic Oncology guidelines note clinicians should inform low-risk prostate cancer patients who are considering focal therapy or high-intensity focused ultrasound (HIFU) that these interventions are not standard care options because comparative outcome evidence is lacking. Accordingly, the long term efficacy of the services at issue has not been established in this clinical setting. All told, transrectal HIFU including imaging guidance performed on 12/20/17 was not likely to have been more effective than other treatment options available for evaluating this patients medical condition. 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 57-year-old female enrollee has requested reimbursement for comprehensive cancer genomic panel provided on 5/9/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees rectal carcinoma. | Overturned | Experimental | Summary Reviewer 1
A 57-year-old female enrollee has requested reimbursement for comprehensive cancer genomic panel provided on 5/9/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees rectal carcinoma. The physician reviewer found that patients with refractory or relapsed cancer that have exhausted standard treatments are usually considered for clinical trials. Recently, it has become important to identify mutations that may be amenable to targeted therapy. One study of 86 patients reported that progression free survival (PFS) on regimen selected by molecular profiling was compared to PFS on the last chemotherapy regimen (Von Hoff, et al). The regimen selected by molecular profiling offered a 27% survival advantage. Given this support, the comprehensive cancer genomic panel provided on 5/9/17 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 54-year-old female enrollee has requested authorization and coverage for Xyzal 5 mg two tablets per day. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees allergies and sleep difficulties.
et al). The patient states that she has used Zyrtec in the past but it stopped working. | Upheld | Medical Necessity | Summary Reviewer
A 54-year-old female enrollee has requested authorization and coverage for Xyzal 5 mg two tablets per day. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees allergies and sleep difficulties. The physician reviewer found that the Xyzal is a second generation piperazine derivative oral anti-histamine. Xyzal is U.S. Food and Drug Administration (FDA) approved for the treatment of allergic rhinitis, seasonal allergic rhinitis orally at 2.5 or 5 mg once daily. Higher doses are approved for the treatment of chronic idiopathic urticarial. Oral antihistamines are typically second-line therapy for allergic rhinitis after intranasal corticosteroids (Wallace, et al). The patient states that she has used Zyrtec in the past but it stopped working. However, there is a lack of data that pharmacologic tolerance develops to antihistamines (Simons). Also, there is a paucity of evidence that doses of second-generation antihistamines greater than those maximally recommended increase efficacy for allergic rhinitis (Hansen). Although the patient states that the increased dose of Xyzal has helped her sleeping, this is not an FDA approved indication and would not be considered an extenuating circumstance. In this case, there is a lack of evidence of primary therapies being implemented and failed such as avoidance measures and intranasal corticosteroids (Wallace, et al). As such, the request for Xyzal 5 mg two tablets per day is not medically necessary. Based on the foregoing discussion, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 38-year-old female enrollee has requested authorization and coverage for rituximab infusions at UCSF Medical Center. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees rheumatoid arthritis. | Overturned | Medical Necessity | Summary Reviewer
A 38-year-old female enrollee has requested authorization and coverage for rituximab infusions at UCSF Medical Center. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees rheumatoid arthritis. The physician reviewer found there are multiple studies demonstrating safety for long-term use of rituximab in this clinical setting. However, the risk of infusion reactions occur within 30-120 minutes of infusion and occur in 30-45% of patients. To prevent reactions, there are pretreatment medications which are recommended. Reactions may require aggressive treatments to include treatment of anaphylactic symptoms. It is therefore recommended that the patient continues to receive the rituximab infusions at the UCSF Medical Center. Therefore, the requested rituximab infusions at UCSF Medical Center are supported as medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the requested services are 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 authorization and coverage for verapamil. 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 records document erectile dysfunction secondary to Peyronies plaque formation. He has difficulty maintaining erections and was diagnosed with plaque related erectile issue due to 15 degree lateral curvature. | Upheld | Experimental | Summary Reviewer 3
A 60-year-old male enrollee has requested authorization and coverage for verapamil. 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 there is a lack of support for verapamil injections in this clinical setting. The records document erectile dysfunction secondary to Peyronies plaque formation. He has difficulty maintaining erections and was diagnosed with plaque related erectile issue due to 15 degree lateral curvature. The medical evidence does not support an overall benefit of the use of this medication in terms of erectile outcomes, and the literature has noted minimal benefit to verapamil on lesion size reduction. This patients in-office response to Trimix suggests that his erectile function is intact and curvature is mild. Per the records, the patient may benefit from more standard therapies, inclusive of ultrasound and vacuum devices, to assist with mild curvature. Thus, verapamil is not likely to be of greater benefit than other treatment options.
| 1 |
A 45-year-old female enrollee has requested reimbursement for the breast tomosynthesis performed on 2/6/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the patient is a 45-year-old female with a family history of breast cancer. The patient had a screening mammogram including tomosynthesis performed on 2/6/15 revealing extremely dense tissue but no evidence of malignancy. The patient is requesting reimbursement for the breast tomosynthesis performed on 2/6/15. The Health Insurer has denied this request as investigational. | Overturned | Experimental | Summary Reviewer 2
A 45-year-old female enrollee has requested reimbursement for the breast tomosynthesis performed on 2/6/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the patient is a 45-year-old female with a family history of breast cancer. The patient had a screening mammogram including tomosynthesis performed on 2/6/15 revealing extremely dense tissue but no evidence of malignancy. The patient is requesting reimbursement for the breast tomosynthesis performed on 2/6/15. The Health Insurer has denied this request as investigational. The American College of Radiology (ACR) has urged tomosynthesis be removed from the investigational category in light of the advantages it brings to radiologists in the interpretation of mammograms particularly in cases of extremely dense tissue, such as in this case. The tomographic qualities of tomosynthesis often allow radiologists to separate dense glandular elements from underlying architectural distortion/mass resulting in a decrease in callbacks and increase in detection of small cancers. Thus, the use of tomosynthesis was likely of more benefit to the patient than if she had her study using two-dimensional technique only. 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 52-year-old male enrollee has requested authorization and coverage for olaparib (Lynparza) tablet 100 mg. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees prostate cancer. | Upheld | Experimental | Summary Reviewer 3
A 52-year-old male enrollee has requested authorization and coverage for olaparib (Lynparza) tablet 100 mg. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees prostate cancer. The physician reviewer found that this patient has exhausted several prior lines of therapy. The PARP inhibitor Lynparza was studied in 49 patients with castration resistant prostate cancer (Mateo, et al). In this phase II study, all patients were previously treated with at least two prior regimens for castration resistant disease and all had received prior docetaxel chemotherapy. Among the patients with a DNA repair gene abnormality, 88% demonstrated a response. Given this support, the requested Lynparza tablet 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 |
A 31-year-old female enrollee has requested authorization and coverage for rituximab injection therapy. The Health Insurer has denied this request indicating that the requested therapy is considered investigational for treatment of the enrollees multiple sclerosis, relapsing-remitting. | Overturned | Experimental | Summary Reviewer 2
A 31-year-old female enrollee has requested authorization and coverage for rituximab injection therapy. The Health Insurer has denied this request indicating that the requested therapy is considered investigational for treatment of the enrollees multiple sclerosis, relapsing-remitting. The physician reviewer found the current medical evidence does not support the superior efficacy of rituximab injection therapy for treatment of the patients medical condition. The use of rituximab in the treatment of relapsing remitting multiple sclerosis has not been demonstrated in randomized studies to have effectiveness in the treatment of multiple sclerosis relative to disability progression. The Cochrane database representing a meta-analysis review has concluded that there is no demonstration of efficacy of this treatment. Based upon the information set forth above, the requested therapy is not likely to be effective for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 36-year-old female enrollee has requested reimbursement for polymerase chain reaction testing performed on 12/16/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 2
A 36-year-old female enrollee has requested reimbursement for polymerase chain reaction testing performed on 12/16/18. 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 Polymerase chain reaction testing has been compared to traditional clinical testing for vaginitis. The literature supports the use of polymerase chain reaction testing because it resulted in significantly higher sensitivity and negative predictive value than clinician diagnosis or in clinic testing. Schwebke and colleagues noted that polymerase chain reaction testing showed a statistically higher overall percent agreement with each of the reference methods than did clinician diagnosis or clinic testing. The authors noted that the test was also superior for detecting more than one cause for vaginitis. Polymerase chain reaction testing is commonly used in clinical practice. In sum, polymerase chain reaction testing performed on 12/16/18 was likely to have been of greater benefit than other methods of evaluating this patient.
| 0 |
A 49-year-old male enrollee has requested authorization and coverage for 0424T insertion
neurostimulator system for central sleep apnea. The Health Insurer has denied this request and
reported that the requested service is investigational for the treatment of the enrollees central
sleep apnea.
, notes dated 6/18/22 reported a
sleep study dated 12/18/18 reported 27 obstructive apneas, 70 central apneas, zero mixed
apneas, and 85 hypopneas. The patient has failed ASV and other PAP therapy modalities and has
symptomatic central apnea. | Overturned | Experimental | Summary Reviewer 2
A 49-year-old male enrollee has requested authorization and coverage for 0424T insertion
neurostimulator system for central sleep apnea. The Health Insurer has denied this request and
reported that the requested service is investigational for the treatment of the enrollees central
sleep apnea. The physician reviewer found that Ding and Zhang note that transvenous phrenic
nerve stimulation is an effective and safe therapeutic approach that is approved by the FDA for
the treatment of moderate to severe central apnea. In this case, notes dated 6/18/22 reported a
sleep study dated 12/18/18 reported 27 obstructive apneas, 70 central apneas, zero mixed
apneas, and 85 hypopneas. The patient has failed ASV and other PAP therapy modalities and has
symptomatic central apnea. Given that the patient has failed first-line of treatment of central
apnea with ASV and PAP therapy, phrenic nerve stimulation is likely to be more beneficial in this
case than standard therapies. Therefore, 0424T insertion neurostimulator system for central
sleep apnea is likely to be more beneficial for treatment of the patients condition than any
available standard therapy.
| 1 |
A 46-year-old female enrollee has requested authorization and coverage for endovenous ablation therapy of the right SSV. 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. | Overturned | Medical Necessity | Summary Reviewer
A 46-year-old female enrollee has requested authorization and coverage for endovenous ablation therapy of the right SSV. 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 current medical evidence supports the requested services in this clinical setting. The Health Insurers denial was based upon the size of the small saphenous vein that will be the target of treatment. Per the records, the vein has reflux. Although increasing saphenous vein size does correlate with severity of vein disease, patients with C2-C3 disease still have been reported to have small saphenous veins measuring as small as 2.4 mm at the junction (mean of 4.3 mm). In order to determine the medical necessity of the treatment, the total clinical picture must be evaluated. In this patients case, she is likely to benefit from the requested services. Therefore, endovenous ablation therapy of the right small saphenous vein is medically necessary for the treatment of this patient. | 0 |
A 38-year-old female enrollee has requested reimbursement for the Anser IFX testing performed on 11/11/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees ulcerative colitis. | Upheld | Experimental | Summary Reviewer 2
A 38-year-old female enrollee has requested reimbursement for the Anser IFX testing performed on 11/11/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees ulcerative colitis. The physician reviewer found that the Anser IFX test was ordered to determine the cause for the patients possible loss of response to Remicade. However, management of ulcerative colitis using the Anser IFX has not been standardized, and recommendations for management based on test results have not been formed (Kornbluth and Sachar). In addition, the use of Anser IFX to direct treatment has not been clinically proven to improve patient outcomes or alter patient management in high-quality controlled clinical trials. The presence of antibodies alone does not necessarily result in loss of response to infliximab, nor have threshold drug levels been established (Steenholdt, et al). Studies have found that anti-infliximab antibodies can be transient, with many patients who have these antibodies maintaining their response (Vande Casteele, et al; Nanda, et al). A recent study concluded that prospective evaluation of the value of measuring serum concentrations of infliximab should be performed before these data can be included in patient management strategies (Adedokun, et al). One study, with some patients undergoing dose intensification following initial non-response, showed no difference in serum levels of infliximab between patients who responded to dose intensification versus those who did not (Pariente, et al). Based on the clinical literature, the Anser IFX testing performed on 11/11/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The patient is a 22-year-old female who was transferred by air ambulance from Swedish Medical Center (SMC) in Englewood, Colorado, to St. Josephs Hospital (SJH) in Phoenix, Arizona, on 9/26/19. The patient has a medical history significant for mild autism, attention deficit/hyperactivity disorder, and non-epileptic seizures. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 22-year-old female who was transferred by air ambulance from Swedish Medical Center (SMC) in Englewood, Colorado, to St. Josephs Hospital (SJH) in Phoenix, Arizona, on 9/26/19. The patient has a medical history significant for mild autism, attention deficit/hyperactivity disorder, and non-epileptic seizures. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. In order for air ambulance transportation to be medically necessary, specific criteria should be met. First, the patients condition must be such that any form of transportation other than ambulance would be medically contraindicated. Additionally, the patients condition must be such that time needed to transport by ground poses a threat to the patients survival. Also, the patient should be
transported to the nearest hospital with appropriate facilities for treatment, and there should be a medical condition that is life-threatening. When transporting from one facility to another, the above criteria must be met, and the first hospital must not have the required services and facilities to treat the patient.
In this patients case, she had nonepileptic seizures, or psychogenic nonepileptic spells. Psychogenic nonepileptic spells (PNES) or psychogenic nonepileptic episodes (PNEE) are terms used to describe events that appear to be epileptic seizures but in fact do not represent the manifestation of excessive synchronous cortical activity that defines epileptic seizures. They are not a variation of epilepsy, but are of psychiatric origin. These terms reinforce the idea that the events are not seizures of any type, and PNES is used as a synonym for pseudoseizures. Distinguishing PNES from epileptic seizures may be difficult at the bedside even to experienced observers. In theory, almost any recurrent behavior may represent epileptic seizures. The simultaneous utilization of video and EEG recordings are key to diagnosis, as was the case here. This patient had PNES, and she was under the care of a neurologist at SMC. Her condition was stable. Had there been a need for higher level of care, SJH in Phoenix, Arizona was not the closest facility capable of providing that care. Indeed, the patients family requested transport to Arizona so that the patients mother would be able to oversee her care and make medical decisions for the patient. Therefore, air ambulance transportation provided on 9/26/19 was not medically necessary for the treatment of this patient. | 1 |
The parent of a 14-year-old female enrollee has requested reimbursement for mental health residential treatment from 9/28/15 through 10/05/15 and prospective authorization and coverage for mental health residential treatment. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health conditions.T
. The patient was not suicidal or homicidal. She denied self-harm urges. She was not aggressive towards others, and her body weight was stable. She had no medical or psychiatric conditions
a lower level of care. Her mother was supportive and actively participated in her care. Per the medical records, the patient had improved and no longer required 24-hour medical or nursing supervision. | Upheld | Medical Necessity | Summary Reviewer
The parent of a 14-year-old female enrollee has requested reimbursement for mental health residential treatment from 9/28/15 through 10/05/15 and prospective authorization and coverage for mental health residential treatment. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health conditions.The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. The patient was not suicidal or homicidal. She denied self-harm urges. She was not aggressive towards others, and her body weight was stable. She had no medical or psychiatric conditions that would interfere with her ability to return to a lower level of care. Her mother was supportive and actively participated in her care. Per the medical records, the patient had improved and no longer required 24-hour medical or nursing supervision. Therefore, mental health residential treatment from 9/28/15 through 10/05/15 and future mental health residential treatment was not and is not medically indicated for the treatment of this patient. Therefore, the services at issue were not and are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 63-year-old male enrollee has requested reimbursement for CPT 64999 (unlisted procedure, nervous system, right wrist anterior and posterior interosseous neurectomy) performed on 6/10/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that this patient presented with chronic right wrist pain that interfered with his activities of daily living. He had a past medical history that included right distal radius fracture. Clinical examination findings were consistent with imaging evidence of right wrist post-traumatic arthritis of the radioscaphoid joint and STT joint with positive ulnar variance of 7.5 mm. He had failed to achieve sustained improvement with activity modification, medications, bracing and steroid injection. He underwent right wrist anterior and posterior interosseous neurectomies on 6/10/19 as an alternative to motion-limiting surgeries, including wrist fusion, proximal row carpectomy, and radioscapholunate arthrodesi | Overturned | Experimental | Summary Reviewer 1
A 63-year-old male enrollee has requested reimbursement for CPT 64999 (unlisted procedure, nervous system, right wrist anterior and posterior interosseous neurectomy) performed on 6/10/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that this patient presented with chronic right wrist pain that interfered with his activities of daily living. He had a past medical history that included right distal radius fracture. Clinical examination findings were consistent with imaging evidence of right wrist post-traumatic arthritis of the radioscaphoid joint and STT joint with positive ulnar variance of 7.5 mm. He had failed to achieve sustained improvement with activity modification, medications, bracing and steroid injection. He underwent right wrist anterior and posterior interosseous neurectomies on 6/10/19 as an alternative to motion-limiting surgeries, including wrist fusion, proximal row carpectomy, and radioscapholunate arthrodesis. Current evidence-based medical literature supports the use of anterior and/or posterior interosseous neurectomies for the treatment of chronic wrist pain and to delay or avoid wrist fusion/reconstruction surgeries. There is adequate literature support for the use of this procedure as salvage prior to fusion. He had failed reasonable and/or comprehensive conservative treatment, and no additional conservative treatment would have been reasonably expected to improve his medical condition. Therefore, CPT code 64999 (unlisted procedure, nervous system, right wrist anterior and posterior interosseous neurectomy) performed on 6/10/19 was likely to have been more beneficial for treatment of the patientas medical condition than any available standard therapy.
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An 18-year-old male enrollee has requested authorization and coverage for genioplasty sliding osteotomy. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees medical condition.
. This patient has an overly projected chin with excessive vertical height and a poorly defined labiomental fold. The mandible is already over-projected. | Upheld | Medical Necessity | Summary Reviewer
An 18-year-old male enrollee has requested authorization and coverage for genioplasty sliding osteotomy. 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 osteoplastic genioplasty is a procedure that has been used for the treatment of sleep apnea with limited success. When the mandible is retrusive, usually a Class II malocclusion with an under projecting chin, an argument for sliding osteoplastic genioplasty would be a reasonable consideration. Theoretically, moving the chin forward, or anterior, will advance the tongue base forward and enlarge the hypopharyngeal airway. However, this is not the situation in this case. This patient has an overly projected chin with excessive vertical height and a poorly defined labiomental fold. The mandible is already over-projected. Thus, the osteoplastic genioplasty is being done to reduce the vertical height of the chin, not to advance the chin forward. This is done to improve the long face created by the excessive height of the mandible, and improve the aesthetics of the face by creating a more defined labiomental crease, but it will not improve the patients airway. There is an alternate indication for osteoplastic genioplasty. When performing maxillary advancement, bone grafts may be necessary to stabilize the maxilla. One source of bone is the mandible. If a bone graft is needed and this provides an adequate amount of bone, then a rib or cranial bone graft would not be needed. In this case, the surgeon did not include bone graft in the requested procedures. In sum, genioplasty sliding osteotomy in this clinical setting will not improve tongue position or add to improvement in the airway. As such, the requested services are not medically necessary for treatment of the patients medical condition. Thus, the requested services are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 21-year-old female enrollee has requested reimbursement for the Game Ready system provided on 9/10/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 2
A 21-year-old female enrollee has requested reimbursement for the Game Ready system provided on 9/10/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees medical condition. The physician reviewer found there are few published data of cryotherapy devices with respect to health or functional outcomes in the setting of musculoskeletal conditions, including following knee surgery. Hubbard and Denegar reported that, Many more high-quality studies are required to create evidence-based guidelines on the use of cryotherapy. These must focus on developing modes, durations, and frequencies of ice application that will optimize outcomes after injury. There is some limited published literature related to hip and knee surgery. The medical literature does not indicate, however, that the use of these cooling devices is necessary in the postoperative period outside of the hospital, particularly when a patient is ambulatory. There is also insufficient high quality evidence that establishes that the use of cooling devices results in better outcomes over the use of topical ice pack application. All told, the Game Ready system provided on 9/10/15 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.
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patient is a 56-year-old male enrollee who has requested reimbursement for Oncotype DX Prostate. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of this patient. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 56-year-old male enrollee who has requested reimbursement for Oncotype DX Prostate. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of this patient. The physician reviewer found that The National Comprehensive Cancer Network (NCCN) guidelines define the low-risk group as patients with clinical stage T1 to T2a, Grade Group 1, and serum prostate-specific antigen (PSA) level less than 10 ng/mL. If the patients life expectancy is 10 years or more, initial treatment options include: 1) active surveillance (preferred); 2) external beam radiotherapy or brachytherapy; or 3) radical prostatectomy. This patient meets this criteria. Molecular tumor testing can be considered for these men for prognostic information independent of NCCN risk groups. There is sufficient support for the services at issue in this clinical setting. Therefore, Oncotype DX Prostate testing performed on 9/19/19 was medically necessary for the evaluation of this patient. | 1 |
patient is a 54-year-old male who presented to his provider on 3/11/22 with avascular necrosis
of the left hip. The patient has requested reimbursement for inpatient disc replacement, lumbar,
from 11/8/22 through 11/9/22. The Health Insurer has denied this request and reported that the
service at issue was not medically necessary for the treatment of this patient.
. In this case, the patient had multilevel degenerative disc disease with
severe disc collapse at L4-L5 and L5-S1, and boney spinal stenosis at L5-S1 on MRI. The records
noted that a CT scan reported the facet joints to be within normal limits. The patient received
multiple steroid epidural injections every three months with limited relief and had avascular
necrosis of his hip joint requiring total hip replacement, suggesting uncontrollable radicular | Upheld | Medical Necessity | Summary
The patient is a 54-year-old male who presented to his provider on 3/11/22 with avascular necrosis
of the left hip. The patient has requested reimbursement for inpatient disc replacement, lumbar,
from 11/8/22 through 11/9/22. The Health Insurer has denied this request and reported that the
service at issue was not medically necessary for the treatment of this patient. This denial is the
subject of this appeal and determination. The physician reviewer found that the submitted
documentation does not support the medical necessity of the services at issue. Lumbar total disc
replacement is a good surgical option for relatively young patients with discogenic low back pain
with or without radiculopathy that is limited to one spinal level, and is more suitable for patients
with discogenic lumbar pain. The procedure does not address posterior structures, which in this
case are potential sources of pain and instability given the patients prior hemilaminotomy, so any
posterior pain source, or severe stenosis as seen on MRI, is unlikely to resolve after total disc
replacement. With severe boney stenosis, as in this patients case, preserving the segment motion
with total disc replacement can induce more osteophytes and stenosis. Osteophyte production also
places the patient at risk for development of heterotopic ossification, which would limit
preservation of motion. In this case, the patient had multilevel degenerative disc disease with
severe disc collapse at L4-L5 and L5-S1, and boney spinal stenosis at L5-S1 on MRI. The records
noted that a CT scan reported the facet joints to be within normal limits. The patient received
multiple steroid epidural injections every three months with limited relief and had avascular
necrosis of his hip joint requiring total hip replacement, suggesting uncontrollable radicular
symptoms by conservative measures. The patients multilevel lumbar spine degeneration with
foraminal and boney lateral recess spinal stenosis, boney osteophytes, and ossified disc protrusion
at L5-S1 resulted in severe lateral recess stenosis and impingement on the traversing left S1 nerve
root. To achieve proper decompression of neural elements, particularly with this patients boney
stenosis, adequate decompression of stenosis is likely to further destabilize the segment in a
previously decompressed segment, and severe disc collapse is a relative contraindication for disc
replacement. Additionally, posterior decompression is likely to be more effective than anterior
discectomy. In this case, the nature of the pathology with multilevel disease was not the ideal
indication for total disc replacement, particularly in the setting of required spinal fusion at the
adjacent levels. In this clinical setting, given the patients prior decompression at L5-S1 and the
amount of boney stenosis noted in the MRI, the service at issue was unlikely to provide adequate
or lasting relief for the patient symptoms and was not medically indicated. Therefore, inpatient
disc replacement, lumbar, from 11/8/22 through 11/9/22, was not medically necessary for the
treatment of this patient.
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A 58-year-old female enrollee has requested reimbursement for blepharoplasty of the upper eyelid performed on 12/07/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. | Upheld | Medical Necessity | Summary Reviewer
A 58-year-old female enrollee has requested reimbursement for blepharoplasty of the upper eyelid performed on 12/07/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. The blepharoplasty was not medically necessary based on the lack of appropriate visual field studies and the lack of photographic evidence. In this setting, a suprathreshold static visual field test would have been appropriate rather than the full threshold test that was done in this case. In addition, the results provided were grayscale representations of the field, not the actual visual field test result. Thus, it is not possible to determine the degree from fixation where the absolute scotoma begins. There were no photographs to support the need for functional surgery. Therefore, upper eyelid blepharoplasty performed on 12/07/18 was not medically necessary for the treatment of this patient. | 0 |
A 35-year-old female has requested reimbursement and prospective authorization and coverage for transcranial magnetic stimulation provided from 9/15/16 through 4/17/17. The Health Insurer has denied this request indicating that the services at issue were and are considered investigational for treatment of the enrollees major depressive disorder.
, the patient did show an initial response to TMS treatment. The records indicate that the patients symptoms had improved during the initial TMS treatment period. | Upheld | Experimental | Summary Reviewer 3
A 35-year-old female has requested reimbursement and prospective authorization and coverage for transcranial magnetic stimulation provided from 9/15/16 through 4/17/17. The Health Insurer has denied this request indicating that the services at issue were and are considered investigational for treatment of the enrollees major depressive disorder. The physician reviewer found this patient received 36 treatments prior to the Health Insurers denial. At this time, the literature on TMS is not clear on whether maintenance treatment is an evidence-based treatment. The literature indicates that continued treatment can and should occur if an initial response to TMS is not apparent. However, in this case, the patient did show an initial response to TMS treatment. The records indicate that the patients symptoms had improved during the initial TMS treatment period. Since the patient showed benefit from acute/initial TMS treatments and given the lack of evidence for maintenance TMS treatments, the superior effectiveness of the services at issue has not been established. Based upon the information set forth above, the services at issue were not and are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 61-year-old female enrollee has requested reimbursement for neuropsychological testing performed on 12/28/14. The Health Insurer has denied this request indicating that the testing at issue was not medically necessary for treatment of the enrollees medical condition.T
Psychosocially, the patient was relatively new to the community and involved in an emotionally convoluted relationship. In October 2014 she linked her memory issues and insomnia to her poorly controlled anxiety. During that appointment, the provider did not
The patient was prescribed a trio of medications including temazepam, lamotrigine and quetiapine, each of which
. She did not follow through on the recommendation from the psychiatrist earlier in the year to reduce her quetiapine. Lastly, she was consuming alcohol and had reported previously drinking a bottle of wine nightly. During the most recent mental status examination from May 2015, | Upheld | Medical Necessity | Summary Reviewer
A 61-year-old female enrollee has requested reimbursement for neuropsychological testing performed on 12/28/14. The Health Insurer has denied this request indicating that the testing at issue was not medically necessary for treatment of the enrollees medical condition.The physician reviewer found that according to the American Academy of Clinical Neuropsychologys practice guidelines, distinctive features of neuropsychological evaluations and consultations in assessing brain function and dysfunction include the use of objective neuropsychological tests, systematic behavioral observations and interpretations of the findings based on knowledge of the neuropsychological manifestations of brain-related conditions. In this case, the symptom complex was consistent with affective illness and anxiety rather than a disease of neurocognition, such as delirium, dementia, frontotemporal degeneration, Parkinsons disease, prion disease, or Lewy body disease to name a few. Psychosocially, the patient was relatively new to the community and involved in an emotionally convoluted relationship. In October 2014 she linked her memory issues and insomnia to her poorly controlled anxiety. During that appointment, the provider did not include specific examples of the memory decline or objective rating scales such as a Folstein Mini-Mental State Examination or a Montreal Cognitive Assessment. The patient was prescribed a trio of medications including temazepam, lamotrigine and quetiapine, each of which alone could cause cognitive dulling while the concomitant use of the three, particularly when combined with alcohol, commonly causes sedation. She did not follow through on the recommendation from the psychiatrist earlier in the year to reduce her quetiapine. Lastly, she was consuming alcohol and had reported previously drinking a bottle of wine nightly. During the most recent mental status examination from May 2015, the patients speech, thought process, insight and judgement were unimpaired, while her attention span and concentration were within normal limits. Neuropsychological testing is not medically necessary to diagnose anxiety or affective disorders. Further, the patient had not followed through with the recommended medication reductions and she continued to consume alcohol while facing several external stressors. Finally, the patient did not have evidence of a neurocognitive disorder while her most recent mental status examination was normal. In sum, the documentation submitted for review does not support the medically necessity for the neuropsychological testing performed on 12/28/14.Therefore, the testing at issue was not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 23-year-old female enrollee has requested reimbursement for realignment of the right jaw joint (condylotomy) performed on 4/29/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for the treatment of the enrollees temporomandibular joint pain.
This patient has been diagnosed with temporomandibular joint disease and was treated non-surgically. However, this failed to resolve her symptoms. The records document an internal derangement of her right temporomandibular joint with persistent symptoms. | Overturned | Medical Necessity | Summary Reviewer
A 23-year-old female enrollee has requested reimbursement for realignment of the right jaw joint (condylotomy) performed on 4/29/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for the treatment of the enrollees temporomandibular joint pain. The physician reviewer there is sufficient support for the services at issue in this clinical setting. This patient has been diagnosed with temporomandibular joint disease and was treated non-surgically. However, this failed to resolve her symptoms. The records document an internal derangement of her right temporomandibular joint with persistent symptoms. The modified condylotomy is a well-known procedure with a high success rate. The current medical evidence supports the services at issue in this clinical setting. All told, realignment of the right jaw joint (condylotomy) performed on 4/29/16 was medically indicated for the treatment of this patient. Therefore, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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A 34-year-old male enrollee has requested authorization and coverage for Bicillin L-A. The Health Insurer has denied this request indicating that the requested medication is investigational for the treatment of the enrollees medical condition. The physician reviewer found the patient is a 34-year-old male who has been diagnosed with persistent Lyme disease. He had a positive IgM Western blot for Lyme with a negative IgG western blot for Lyme on 3/28/13.
. An office visit note dated 9/9/15 indicates that the patient reports doing better in general and marked improvement with starting Bicillin. The patient reports improved strength, less tremor/shaking and improvement in cognitive function. The assessments are listed as Lyme disease, anxiety state, attention or concentration deficit, malaise, fatigue, myalgia and myositis, headache, bartonellosis, candidiasis of mouth and disturbance of skin sensation. In the patients appeal letter, he states that has been using Bicillin L-A since July 2015 and has improved shaking and vibrating, more energy, less tingling, trouble walking, memory and nerve problems and more. The patient has requested authorization and coverage for Bicillin L-A. The Health Insurer has denied this request as investigational. | Upheld | Experimental | Summary Reviewer 2
A 34-year-old male enrollee has requested authorization and coverage for Bicillin L-A. The Health Insurer has denied this request indicating that the requested medication is investigational for the treatment of the enrollees medical condition. The physician reviewer found the patient is a 34-year-old male who has been diagnosed with persistent Lyme disease. He had a positive IgM Western blot for Lyme with a negative IgG western blot for Lyme on 3/28/13. There is no further laboratory testing submitted to support a diagnosis of secondary, tertiary or chronic Lyme or neuroborreliosis. An office visit note dated 9/9/15 indicates that the patient reports doing better in general and marked improvement with starting Bicillin. The patient reports improved strength, less tremor/shaking and improvement in cognitive function. The assessments are listed as Lyme disease, anxiety state, attention or concentration deficit, malaise, fatigue, myalgia and myositis, headache, bartonellosis, candidiasis of mouth and disturbance of skin sensation. In the patients appeal letter, he states that has been using Bicillin L-A since July 2015 and has improved shaking and vibrating, more energy, less tingling, trouble walking, memory and nerve problems and more. The patient has requested authorization and coverage for Bicillin L-A. The Health Insurer has denied this request as investigational.
Based on the documentation submitted for review, there is a lack of evidence demonstrating the patient has chronic Lyme disease. The laboratory data shows that he may have had acute or early Lyme in September 2013, but no evidence of ongoing infection is submitted. In the absence of evidence of ongoing infection with Borrelia or any other tick born disease, antibiotic treatment is less likely to be of benefit. In addition, the Infectious Diseases Society of America (IDSA) guidelines report that long term antibiotic treatment does not improve the outcome in patients suffering from Lyme, post Lyme or chronic Lyme. Thus, continued use of antibiotics beyond a month without evidence of ongoing infection cannot be justified. Given the above, Bicillin L-A 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 57-year-old male enrollee has requested reimbursement for automated nerve conduction testing performed on 10/20/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 1
A 57-year-old male enrollee has requested reimbursement for automated nerve conduction testing performed on 10/20/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition. The physician reviewer found that the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The study by Schmidt and colleagues compared the specificity and sensitivity of a hand-held nerve conduction study device for the detection of lumbosacral radiculopathy with a standard electrodiagnostic study. The authors noted correlation between the electrodiagnostic findings and the automated hand-held surface testing in only a small number of the patients studied. The authors concluded that it was unlikely that larger study numbers would have increased specificity to acceptable levels. In sum, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 30-year-old female enrollee has requested reimbursement for bony correction bunionectomy to treat symptomatic hallux valgus performed on 6/10/19 and 7/29/19. The Health Insurer has denied this request indicating that the services at issue were investigational for the treatment of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 2
A 30-year-old female enrollee has requested reimbursement for bony correction bunionectomy to treat symptomatic hallux valgus performed on 6/10/19 and 7/29/19. The Health Insurer has denied this request indicating that the services at issue were investigational for the treatment of the enrollees medical condition. The physician reviewer found that the non-surgical treatment is the initial treatment of choice for symptomatic hallux valgus deformity. Shoe modification, padding and local application of ice to symptomatic bunion are reasonable initial conservative options. Orthotic devices to control documented biomechanical dysfunction may be considered as conservative or post-surgical options. Surgical treatment is recommended if there is no or little response to non-operative treatment after a six-month trial, or if initial response deteriorates. In general, once surgical criteria has been met, the surgical procedures to be performed are based on the location and the degree of deformity. The two most common radiographic measurement used to choose appropriate surgical procedures include the intermetatarsal angle (IMA) and the hallux valgus angle (HVA). For IMAs less than 13 degrees, distal osteotomy or soft tissue procedure alone are sufficient to correct the deformity. For IMAs greater than 13 degrees, a proximal osteotomy is recommended. There is a variety of osteotomies described to correct the IMA, including the scarf, and no procedure has proved superiority over the other. Regarding the HVA, angles less than 30 degrees can be treated with a distal soft tissue procedure, such as the modified McBride procedure, with or without a chevron osteotomy. For HVA greater than 40 degrees, metatarsophalangeal joint fusion is generally recommended.
In this patients case, operative criteria have been met. Based on the radiographs and the HVA and IMA measurements reported by the treating surgeon, appropriate surgical procedures were performed and are supported by published treatment guidelines for the treatment of symptomatic hallux valgus. In sum, bony correction bunionectomy to treat symptomatic hallux valgus performed on 6/10/19 and 7/29/19 was likely to have been more beneficial than other treatment options.
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A 47-year-old female enrollee has requested reimbursement for back surgery (lumbar spine fusion) performed on 9/3/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees back pain. A review of the record indicates that the enrollee has a history of low back pain. The enrollee reported that she was involved in a motor vehicle accident in 2011. The enrollee has had conservative therapies with multiple providers to relieve her back pain. Objective findings include radiographic and diagnostic evaluations. The enrollee has requested reimbursement for a back surgery performed on 9/3/14.
The Health Insurer indicates that the documentation provided did not meet the Health Ins | Upheld | Medical Necessity | Summary Reviewer
A 47-year-old female enrollee has requested reimbursement for back surgery (lumbar spine fusion) performed on 9/3/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees back pain. A review of the record indicates that the enrollee has a history of low back pain. The enrollee reported that she was involved in a motor vehicle accident in 2011. The enrollee has had conservative therapies with multiple providers to relieve her back pain. Objective findings include radiographic and diagnostic evaluations. The enrollee has requested reimbursement for a back surgery performed on 9/3/14.
The Health Insurer indicates that the documentation provided did not meet the Health Insurers clinical criteria for the services at issue. Therefore, reimbursement for the back surgery was denied. At issue in this case is whether the services at issue were medically necessary for treatment of the enrollees medical condition.I have determined that the services at issue were not medically necessary for treatment of the patients medical condition. Therefore, the Health Insurers denial should be upheld.
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A 62-year-old male enrollee has requested reimbursement for the mobile heart monitor provided on 8/2/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees palpitations.
records provided the patient presented with near daily palpitations. | Overturned | Experimental | Summary Reviewer 3
A 62-year-old male enrollee has requested reimbursement for the mobile heart monitor provided on 8/2/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees palpitations. The physician reviewer found that based on the records provided the patient presented with near daily palpitations. In this circumstance, if additional evaluation for a dysrhythmia is thought to be indicated then serial 48-hour Holter monitoring or off-line self-activated or auto-triggered cardiac event monitoring should be sufficient in recording cardiac rhythm during symptoms. There is a lack of documentation to indicate that these devices have already been tried and failed for evaluation of the patients current symptoms. Current expert consensus guidelines endorsed by several national organizations also consider Holter monitoring and/or patient-activated or auto-triggered event recorders appropriate initial tests and standard of care for evaluation of dysrhythmias. Immediate recognition and reporting of dysrhythmias through a call center provided by real-time mobile telemetry services has not been shown to improve health outcome compared to standard monitoring techniques. For these reasons, the mobile heart monitor provided on 8/2/17 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 service 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 male enrollee has requested reimbursement for physical therapy services provided from 1/5/15 through 10/27/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees multilevel stenosis.
The patient has had extensive prior PT and should be well versed in a home exercise program. | Upheld | Medical Necessity | Summary Reviewer
A 63-year-old male enrollee has requested reimbursement for physical therapy services provided from 1/5/15 through 10/27/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees multilevel stenosis. The physician reviewer found that although a multidisciplinary approach to spine pain including PT may be beneficial, the goal of therapy is to transition to an independent home exercise program without continued dependence on supervised therapy. The documentation does not indicate that prior extensive PT before 1/5/15 resulted in significant objective increase in overall function. The services at this point do not need to be only under the supervision of a therapist. The patient has had extensive prior PT and should be well versed in a home exercise program. The additional requested therapy is not accepted as specific and effective therapy for this patients condition. Further, the patients expected rehabilitation potential is not significant in relation to the extent and duration of PT services required. The specialized skill of a qualified therapist is not required to establish, design and/or deliver a maintenance program to maintain the patients current condition or to prevent or slow further deterioration. All told, the PT services provided from 1/5/15 through 10/27/15 were not medically necessary for treatment of this patients medical condition.
Based on the foregoing discussion, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 46-year-old female enrollee has requested authorization and coverage for total disc arthroplasty (CPT 22858 and 22856). The Health Insurer has denied this request indicating that the requested services are investigational for treatment of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 3
A 46-year-old female enrollee has requested authorization and coverage for total disc arthroplasty (CPT 22858 and 22856). The Health Insurer has denied this request indicating that the requested services are investigational for treatment of the enrollees medical condition. The physician reviewer found it is not likely to be beneficial for this patient to undergo two-level cervical intervertebral disc arthroplasty. There are general concerns referencing cervical artificial disc replacement. The properties of wear and the resultant patient response to wear debris from bearing surfaces of hip, knee and spinal disc share the same phenomenon. There is a predictable level of long-term complications after total hip and total knee replacement, which are attributable to the problems of wear. The techniques for revision after total disc arthroplasty are controversial. If the patients implant fails with either edge wearing of the methyl methacrylate portion of the implant or subsidence of the metallic components into the vertebral bodies, then a second anterior approach may become necessary. This approach would have increased risk since the tissues through which the surgical approach is made have already undergone postoperative scarring. Studies of longer duration are needed to assess the longer term potential complications of a methyl methacrylate arthroplasty within the cervical spine. There is documentation in the literature for an increased incidence of dysphasia following a repeat anterior approach to the cervical spine. A justification and rationale for total disc arthroplasty is the prevention of adjacent segment disorder through preservation of motion. However, it remains controversial whether or not motion at the replaced intervertebral disc will be maintained over time. Thus, the requested total disc arthroplasty is not likely to be more effective than other treatment options. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
A 57-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing provided on 8/30/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas melanoma. | Upheld | Experimental | Summary Reviewer 1
A 57-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing provided on 8/30/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas melanoma. The physician reviewer found that the prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index may add a bit to these statistics. DecisionDx-Melanoma testing is a study of 31 genes in an individualas melanoma cells. It then classifies that particular melanoma based on the five-year risk of metastasis. Gerami reported on 217 cases, with good correlation between prognosis and DecisionDx-Melanoma class, in patients who had had sentinel node biopsy. 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 the DecisionDx-Melanoma assay can be used to make clinical decisions. Therefore, DecisionDx-Melanoma testing provided on 8/30/19 was not likely to have been more beneficial than other methods of evaluating this patient.
| 0 |
A 36-year-old female enrollee has requested reimbursement for gene testing (MaterniT21 Plus) performed on 2/03/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees pregnancy. | Upheld | Experimental | Summary Reviewer 2
A 36-year-old female enrollee has requested reimbursement for gene testing (MaterniT21 Plus) performed on 2/03/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees pregnancy. The physician reviewer found there is a lack of support for the services at issue in this clinical setting. As noted by the American College of Obstetricians and Gynecologists, regardless of the method, the accuracy of screening for aneuploidy is limited in multiple gestations. With any method based on maternal blood, only a single composite result for the entire gestation is provided, with no ability to distinguish a differential risk between fetuses. The data regarding the performance of cell free DNA screening in twin gestations are limited. Although preliminary findings suggest that this screening is accurate, larger prospective studies and published data are needed before this method can be recommended for multiple gestation. Cell free DNA screening is not recommended for women with multiple gestation. Additionally, the patient underwent testing at just over seven weeks gestation, which is earlier than recommended. Therefore, gene testing (MaterniT21 Plus) performed on 2/03/15 was not likely to have been of greater benefit than other modalities for evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
A 51-year-old female has requested reimbursement for destruction by neurolytic agent (CPT codes 64635 and 64636) performed on 12/02/13 and 12/23/13. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition.
This patient had both axial and radicular pain complaints. The right lumbar medial branch nerve blocks and cooled lumbar medial branch nerve radiofrequency ablation at L3, L4, and L5 were | Overturned | Experimental | Summary Reviewer 3
A 51-year-old female has requested reimbursement for destruction by neurolytic agent (CPT codes 64635 and 64636) performed on 12/02/13 and 12/23/13. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition. The physician reviewer found there is sufficient support for the services at issue in this clinical setting. This patient had both axial and radicular pain complaints. The right lumbar medial branch nerve blocks and cooled lumbar medial branch nerve radiofrequency ablation at L3, L4, and L5 were aimed at the axial component of the back pain. Radiofrequency ablation is a standard, widely accepted treatment for axial lumbar back pain. Thus, the services at issue performed on 12/02/13 and 12/23/13 were likely to have been superior over other treatment alternatives. Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 47-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing
performed on 8/26/21. The Health Insurer has denied this request and reported that the services
at issue were investigational for the evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 3
A 47-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing
performed on 8/26/21. The Health Insurer has denied this request and reported that the services
at issue were investigational for the evaluation of the enrollees medical condition. The physician
reviewer found that current guidelines recommend using histopathologic features of the
melanoma and consideration of sentinel lymph node biopsy to accurately stage and
prognosticate localized cutaneous melanoma. Gene expression profile (GEP) testing and other
molecular testing platforms are being tested in melanoma for risk stratification, but no high level
evidence has shown they are superior to established standards, and some data suggests they
perform poorly in stage I disease. Furthermore, GEP testing does not inform on treatment of
localized, early stage disease. Therefore, DecisionDx-Melanoma testing performed on 8/26/21
was not likely to have been more beneficial than any available standard therapy.
| 0 |
A 59-year-old female enrollee has requested reimbursement for the Veracyte Afirma genetic testing provided on 12/3/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees thyroid nodule.
case, the patient was facing total thyroidectomy if malignancy was present and subtotal thyroidectomy if the lesion turned out to be benign. Hence, the sample was submitted to Veracyte for gene expression analysis. The case file has | Overturned | Experimental | Summary Reviewer 2
A 59-year-old female enrollee has requested reimbursement for the Veracyte Afirma genetic testing provided on 12/3/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees thyroid nodule. The physician reviewer found that Thyroid nodules are commonly managed by diagnostic fine needle aspiration to evaluate the cytopathology. In this case the finding by this standard technique was atypia of undetermined significance (Baloch, et al). This diagnostic category creates a dilemma with regards to recommended surgery. In this case, the patient was facing total thyroidectomy if malignancy was present and subtotal thyroidectomy if the lesion turned out to be benign. Hence, the sample was submitted to Veracyte for gene expression analysis. The case file has a white paper from the carrier that appears to support mutational testing. However, in a large study of over 500 patients, 6-14% of these with atypia of undetermined significance were found to have malignancy on pathology review but no mutation in several known oncogenic pathways (Nikiforov, et al). In contrast, the gene expression test done by Veracyte has demonstrated a very high negative predictive value for malignancy (Alexander, et al). All told, the Veracyte Afirma genetic testing performed on 12/3/14 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, I have determined the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
The patient is a 37-year-old male who presented to his provider on 5/10/22. The patient has
requested authorization and coverage for Stelara 90 mg/mL syringe.
In this case,
the patient has a history of severe Crohns disease diagnosed before age 30, with a history of
stricture, fistula, and recent need for surgery. He has failed multiple biologi | Overturned | Medical Necessity | Summary Reviewer
The patient is a 37-year-old male who presented to his provider on 5/10/22. The patient has
requested authorization and coverage for Stelara 90 mg/mL syringe. The physician reviewer
found that the submitted documentation supports the medical necessity of the requested
medication regimen. Current medical literature supports dose escalation of Stelara to 90 mg
every four weeks in this case. The mechanism of Stelara (ustekinumab) is entirely different than
that of anti-tumor necrosis factor (TNF) medications, which the patient has failed. Ustekinumab
has been demonstrated to be safe and effective for induction and maintenance of remission in
patients with moderate-to-severe Crohns disease that was resistant to anti-TNF therapy. In a
study of patients with anti-TNF resistant Crohns disease, Kopylov and colleagues observed an
initial clinical response to subcutaneous ustekinumab in 73.7% of the patients. The study showed
dosing at 90 mg every four weeks was used frequently to address inadequate disease control,
and a large proportion of patients were able to maintain response with dose escalation to 90 mg
every four weeks. Multiple studies have shown that a majority of patients in whom Stelara dosing
every eight weeks failed to control symptoms responded to dosing every four weeks. In this case,
the patient has a history of severe Crohns disease diagnosed before age 30, with a history of
stricture, fistula, and recent need for surgery. He has failed multiple biologic and conventional
alternatives, and the records note ongoing disease symptoms while on Stelara every eight weeks.
While a Stelara level of at least 4.5 ug/mL is associated with effective disease control, laboratory
testing results noted an undetectable Stelara level and lack of anti-Stelara antibodies.
Continuation of dosing at every eight weeks or discontinuation of Stelara may result in loss of
disease control, with complications such as fistula, stricture, bowel obstruction, flare,
hospitalization, need for surgery, or other complications. Therefore, Stelara 90 mg/mL syringe is
medically necessary for the treatment of this patient.
| 1 |
A 59-year-old enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 4/20/20. 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 59-year-old enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 4/20/20. 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 the staging and classification of cutaneous melanoma has classically been described by Balch. Mitotic index has been thought to add a bit to the statistics. DecisionDx-Melanoma testing is an assay of 31 genes in the cells of an individualas melanoma cells. It then classifies that melanoma based on the five-year risk of metastasis. It is not known how the five-year DecisionDx-Melanoma testing data compares to the 10-year Balch data. Additionally, it is not clear if the DecisionDx-Melanoma classification can be used to make therapeutic decisions, such as whether to do a sentinel node and/or give adjuvant therapy. Therefore, DecisionDx-Melanoma testing performed on 4/20/20 was not likely to have been more beneficial than other available methods of evaluating this patient.
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A 48-year-old female enrollee has requested authorization and coverage for reconstructive lymphedema surgeries and one (1) inpatient bed day. 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 3
A 48-year-old female enrollee has requested authorization and coverage for reconstructive lymphedema surgeries and one (1) inpatient bed day. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. At issue is whether the requested services are likely to be more beneficial for treatment of the enrolleeas condition than any available standard therapy. The physician reviewer found that vascularized lymph node transfer is commonly performed in cancer centers to treat lymphedema. Postmastectomy lymphedema can be a difficult problem to manage. Compression therapy is the mainstay of treatment, but the medical literature indicates that microsurgical lymph node transfer or lymphaticovenous anastomosis provides better control of edema when compared to compression. Saaristo and colleagues found lymph node transfer improved lymphedema in the majority of patients and eliminated the need for physiotherapy and compression in one-third of the affected women. The authors concluded, aSimultaneous breast and lymphatic reconstruction is an ideal option for patients who suffer from lymphedema after mastectomy and axillary dissection.a Granzow and colleagues noted, aWhen applied appropriately to properly selected patients, surgical procedures used in the treatment of lymphedema are effective and safe.a The medical evidence supports the requested services in this patientas case. Therefore, reconstructive lymphedema surgeries and one (1) inpatient bed day are likely to be more beneficial than other available standard therapy.
| 1 |
The parent of a nine-year-old female enrollee has requested authorization and coverage for Nutropin AQ Nuspin 10. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees short stature.
This patient has idiopathic short stature based on the extreme short stature, normal growth hormone test, normal insulin-l
This patient had a poor growth velocity which greatly improved with a trial of growth hormone | Overturned | Medical Necessity | Summary Reviewer
The parent of a nine-year-old female enrollee has requested authorization and coverage for Nutropin AQ Nuspin 10. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees short stature. The physician reviewer found that the submitted documentation supports the medical necessity of the requested medication in this clinical setting. This patient has idiopathic short stature based on the extreme short stature, normal growth hormone test, normal insulin-like growth factor 1, poor growth velocity and absence of other etiology for short stature. The current guidelines recommend growth hormone therapy for children who have idiopathic short stature. This patient meets these criteria for treatment under the idiopathic short stature diagnosis. She is not likely to attain a normal adult height without this treatment. This patient had a poor growth velocity which greatly improved with a trial of growth hormone therapy. Therefore, Nutropin AQ Nuspin 10 is medically necessary for the treatment of this patient. | 1 |
A 57-year-old male insured has requested authorization and coverage for intraosseous
basivertebral nerve ablation (CPT code 64628). The Health Plan has denied this request indicating
that the requested services are considered investigational for treatment of the insureds chronic
low back pain.
This
patient presents with more than six months of chronic axial low back pain. MRI results
demonstrated changes at disc space endplates L4-5. This patient has undergone more than six
months of conservative treatment consisting of intradiscal steroid injection, home exercise and
physical therapy. | Overturned | Experimental | Summary Reviewer 3
A 57-year-old male insured has requested authorization and coverage for intraosseous
basivertebral nerve ablation (CPT code 64628). The Health Plan has denied this request indicating
that the requested services are considered investigational for treatment of the insureds chronic
low back pain. The physician reviewer found that basivertebral nerve ablation is a minimally
invasive outpatient procedure allowing for a quick recovery. The procedure is implant-free and
preserves spinal integrity by negating need for extensive tissue exposure and disruption.
Additionally, basivertebral nerve ablation fills a treatment gap for patients with chronic low back
pain and preserves future treatment options. In one study, patients with chronic low back pain
who underwent basivertebral nerve ablation reported significant improvement in pain and
function with well documented long-term effectiveness and durability (Fischgrund, et al.). This
patient presents with more than six months of chronic axial low back pain. MRI results
demonstrated changes at disc space endplates L4-5. This patient has undergone more than six
months of conservative treatment consisting of intradiscal steroid injection, home exercise and
physical therapy. Gabapentin, meloxicam and methocarbamol have failed to provide sufficient
and durable relief. This patient does not warrant more invasive treatment, such as
decompression and fusions, as there are no reported severe symptoms of lumbar radiculopathy.
Given these findings the requested intraosseous basivertebral nerve ablation (CPT code 64628)
is likely to be more beneficial than any other available standard treatments for the patients
medical condition.
| 1 |
A 33-year-old male enrollee has requested authorization and coverage for hypoglossal nerve stimulation (64568 and 0466T). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 2
A 33-year-old male enrollee has requested authorization and coverage for hypoglossal nerve stimulation (64568 and 0466T). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation fails to demonstrate the superior efficacy of the requested services. The records do not document what measures were used to make continuous positive airway pressure (CPAP) usage tolerable. There is no record of compliance studies to demonstrate the effectiveness of his CPAP usage. Further guidance and follow-up has been shown to be successful in helping patients adhere to CPAP therapy. The patient also may be a candidate for an oral appliance. Oral appliances have been shown to be highly successful for the treatment of patients with mild and moderate obstructive sleep apnea. In sum, the requested hypoglossal nerve stimulation (64568 and 0466T) is not likely to be superior over other treatment options.
| 1 |
The patient is a 47-year-old male who presented to the emergency department with abdominal/flank pain after a surfing accident. The patient has requested reimbursement for inpatient hospital stay provided on 10/06/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient.
at the time of admission, the patient was hemodynamically stable and afebrile with normal oxygen saturations on room air. His kidney function and hemoglobin levels were normal. The hematuria had cleared. The patient had not failed treatment as an outpatient. He did not require any urgent procedures. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 47-year-old male who presented to the emergency department with abdominal/flank pain after a surfing accident. The patient has requested reimbursement for inpatient hospital stay provided on 10/06/20. 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 at the time of admission, the patient was hemodynamically stable and afebrile with normal oxygen saturations on room air. His kidney function and hemoglobin levels were normal. The hematuria had cleared. The patient had not failed treatment as an outpatient. He did not require any urgent procedures. The inpatient admission was not medically necessary for this patient. Inpatient care is necessary when the patientas signs and symptoms and general medical condition can only be managed safely in an acute inpatient setting, when the patient requires diagnostic studies in an inpatient setting, or if it is medically necessary for the patient to remain in the acute inpatient setting. In this case, the patient was admitted in stable condition and could have been treated at a lower level of care. Therefore, inpatient hospital stay provided on 10/06/20 was not medically necessary for the treatment of this patient. | 1 |
A 28-year-old male enrollee has requested reimbursement for residential treatment center services from 2/1/17 through 2/2/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavior health condition.
the patients nausea and dehydration, which necessitated a bolus of intravenous fluids and
of an anti-emetic medication, the patient did not have a medical condition or psychiatric syndrome that warranted residential placement. The patient was working a program for his addiction and he was motivated in his treatment. The patient had safe and sober housing. He had a supportive family. The patient was not using drugs. The records note that he was tolerating the medications prescribed for his detoxification and insomnia. | Upheld | Medical Necessity | Summary Reviewer
A 28-year-old male enrollee has requested reimbursement for residential treatment center services from 2/1/17 through 2/2/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavior health condition. The physician reviewer found that there is a lack of support for the services at issue in this clinical setting. Although addiction specialty services were indicated, the clinical documentation does not demonstrate the medical necessity of treatment in a 24 hour supervised setting from 2/1/17 through 2/2/17. Despite the patients nausea and dehydration, which necessitated a bolus of intravenous fluids and administration of an anti-emetic medication, the patient did not have a medical condition or psychiatric syndrome that warranted residential placement. The patient was working a program for his addiction and he was motivated in his treatment. The patient had safe and sober housing. He had a supportive family. The patient was not using drugs. The records note that he was tolerating the medications prescribed for his detoxification and insomnia. In sum, outpatient based treatment would have been safe and appropriate at the time. As such, the residential services from 2/1/17 through 2/2/17 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. Therefore, the Health Insurers denial should be upheld. | 1 |
A 57-year-old male enrollee has requested gene testing performed on 9/11/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees uveal melanoma. | Overturned | Experimental | Summary Reviewer 2
A 57-year-old male enrollee has requested gene testing performed on 9/11/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees uveal melanoma. The physician reviewer found that local treatment for primary uveal melanoma is effective in preventing local recurrence in over 95 percent of cases, yet up to 50 percent of patients are at risk for metastatic disease. The high risk of metastatic disease is thought to be due to a propensity for early micrometastasis followed by a variable latency period prior to the emergence of overt metastatic disease. Gene expression profiling (GEP) has been shown to be superior to chromosomal markers, as well as clinical and histopathological prognostic factors, for defining groups at high risk for the development of metastatic disease. Using primary uveal melanoma samples obtained by fine needle biopsy, GEP classifies tumors as having low (class 1) or high (class 2) metastatic potential depending on the expression of 12 discriminating genes and three control genes. This profile test is considered a standard of care. In sum, gene testing performed on 9/11/17 was likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 60-year-old male enrollee has requested reimbursement for CPT 81529, which is an oncology
(cutaneous melanoma, mRNA, gene expression profiling by real-time RT-PCR of 31 genes (28
content and three housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm
reported as recurrence risk including likelihood of sentinel lymph node metastasis, on 3/8/22.
The Health Insurer has denied this request and reported that the service at issue was
investigational for the evaluation of the enrollees melanoma. | Upheld | Experimental | Summary Reviewer 1
A 60-year-old male enrollee has requested reimbursement for CPT 81529, which is an oncology
(cutaneous melanoma, mRNA, gene expression profiling by real-time RT-PCR of 31 genes (28
content and three housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm
reported as recurrence risk including likelihood of sentinel lymph node metastasis, on 3/8/22.
The Health Insurer has denied this request and reported that the service at issue was
investigational for the evaluation of the enrollees melanoma. The physician reviewer found that
the service at issue is not approved by the U.S. Food and Drug Administration (FDA) for the
staging or treatment of melanoma. Current medical literature does not demonstrate the clinical
utility, appropriate use, or improved outcomes for melanoma patients with the use of the service
at issue, and there is insufficient evidence to confirm its reliability or improved outcomes in the
staging or treatment of melanoma. Traditional pathologic factors remain the strongest
independent predictors of recurrence risk. In the setting of a thin melanoma, standard therapy is
a wide local excision followed by periodic skin examination. The service at issue is not
recommended under the National Comprehensive Cancer Network (NCCN) guidelines in this
clinical setting, and the results from the testing would not change the outcome or treatment. The
NCCN further notes that it remains unclear whether gene expression profiling (GEP) platforms
provide clinically actionable prognostic information. The American Academy of Dermatology
guidelines do not report any practical benefit from the use of the service at issue in this clinical
setting. Therefore, CPT 81529, which is an oncology (cutaneous melanoma, mRNA, gene
expression profiling by real-time RT-PCR of 31 genes (28 content and three housekeeping),
utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as recurrence risk including
likelihood of sentinel lymph node metastasis, on 3/8/22, was not likely to have been more
beneficial for evaluation of the patients condition than any available standard therapy.
| 1 |
The patient is a 49-year-old female with a diagnosis of alopecia areata, totalis type, present for the
past three years. The patient has requested authorization and coverage for Xeljanz [tofacitinib
tablets; oral solution, 10 mg (60 per 30 days)]. 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 49-year-old female with a diagnosis of alopecia areata, totalis type, present for the
past three years. The patient has requested authorization and coverage for Xeljanz [tofacitinib
tablets; oral solution, 10 mg (60 per 30 days)]. The Health Insurer has denied this request and
reported that the requested medication is not medically necessary for the treatment of this patient.
This denial is the subject of this appeal and determination. The physician reviewer found that the
submitted documentation supports the medical necessity of the requested medication. While the
U.S. Food and Drug Administration (FDA) does not approve the use of Xeljanz, an oral Janus
kinase (JAK) inhibitor, for the treatment of severe alopecia areata, it does approve the use of
Olumiant (generic name baricitinib), another oral JAK inhibitor, for the treatment of adult patients
with severe alopecia areata. Current medical literature supports the use of Xeljanz in this clinical
setting. Ibrahim and colleagues report that oral tofacitinib is a successful treatment for alopecia
areata. Given that the patient in this case has been treated with Xeljanz with improvement and
without side effects since January 2021, the requested medication is medically indicated.
Therefore, Xeljanz [tofacitinib tablets; oral solution, 10 mg (60 per 30 days)] is medically
necessary for the treatment of this patient.
| 1 |
A 51-year-old female enrollee has requested reimbursement for hyperthermia (77605 and 77600) provided from 11/03/15 through 12/15/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees breast cancer. | Upheld | Experimental | Summary Reviewer 2
A 51-year-old female enrollee has requested reimbursement for hyperthermia (77605 and 77600) provided from 11/03/15 through 12/15/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees breast cancer. The physician reviewer found that hyperthermia is the use of heat to kill cancer cells, which are purportedly more sensitive to high heat than normal cells. It has had some usefulness, when combined with radiation therapy, in the treatment of chest wall recurrences of breast cancer. However, there is a lack of data that it can be used as primary therapy, without radiation, of breast cancer, as has been done in this patient. Hyperthermia alone is not beneficial in this clinical setting. Therefore, hyperthermia (77605 and 77600) provided from 11/03/15 through 12/15/15 was not likely to have been of greater benefit than other treatment alternatives. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
patient is a 59-year-old female with listed diagnoses of inflammatory polyarthropathy, osteoarthritis and fibromyalgia. She has been treated with multiple medications, including prednisone, sulfasalazine, Humira, ibuprofen and Toradol.
This patient reports pain in her back, hands and feet, as well as multiple soft tissue areas. She has been treated with multiple medications to date, all of which have either resulted in side effects or a lack of response. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 59-year-old female with listed diagnoses of inflammatory polyarthropathy, osteoarthritis and fibromyalgia. She has been treated with multiple medications, including prednisone, sulfasalazine, Humira, ibuprofen and Toradol. The physician reviewer found that the submitted documentation fails to support the medical necessity of the requested medication in this clinical setting. This patient reports pain in her back, hands and feet, as well as multiple soft tissue areas. She has been treated with multiple medications to date, all of which have either resulted in side effects or a lack of response. The available medical records do not document objective findings to support the presence of an inflammatory arthritis. There is no documentation of synovitis on physical examination, nor is there documentation of radiologic studies with findings consistent with inflammatory disease. On the basis of this lack of documentation, the requested medication is not medically indicated. Additionally, there is a lack of evidence
supporting the use of H.P. Acthar Gel in fibromyalgia. Therefore, H.P. Acthar 80 unit/mL Gel is not medically necessary for the treatment of this patient. | 1 |
The patient is a 21-year-old male who underwent esophagogastroduodenoscopy with biopsies for a history of abdominal pain, belching, and bloating. The documentation noted a history of hypothyroidism. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 21-year-old male who underwent esophagogastroduodenoscopy with biopsies for a history of abdominal pain, belching, and bloating. The documentation noted a history of hypothyroidism. The physician reviewer found that according to the ASA guideline for anesthesia care during endoscopic procedures, monitored anesthesia care is warranted in prolonged or painful procedures, such as complex polyp resections, endoscopic retrograde cholangiopancreatography or other biliary procedures, endoscopic dilation, or endoscopic resection. Additionally, the guidelines state that monitored anesthesia care may be necessary in patients with failed history of moderate sedation for the procedure or psychological impediments to cooperation. The provided records do not support any of these criteria, or other criteria in the literature, such as difficult intubation, airway obstruction, allergies to sedation medications, chronic alcohol or illicit drug use resulting in increased tolerance to sedation medications, age greater than 70, pregnancy, increased aspiration risk, ASA class III or higher, or morbid obesity. According to the most recent guidelines from the American Society for Gastrointestinal Endoscopy, during endoscopic procedures (unlike surgery) consciousness during the procedure is acceptable and is the goal during most procedures, and monitored anesthesia care is recommended for prolonged procedures requiring deep sedation, previously anticipated intolerance to standard sedatives, ASA class IV or V, or risk for airway obstruction due to anatomic variant. In this case, the records do not support the medical necessity of monitored anesthesia care over conscious sedation. Therefore, anesthesia services provided on 5/07/19 was not medically necessary for the treatment of this patient. | 1 |
The parent of a 15-year-old female enrollee has requested reimbursement and prospective authorization and coverage for mental health residential treatment provided from 2/02/19 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 medical records indicate that the patient was not actively suicidal. In terms of functional status, the records
2. The patient has had some issues with level of function due to mental illness and relational issues, but overall showed appropriate daily functioning while in treatment and indicated prior school functioning was good.
does not have a history of active serious medical issues, and her prior substance use was described
The patient was noted to have a strained relationship with her family and indicated some mild stress at home.
The patient had some outpatient mental health therapy prior to her residential admission but continued to have some symptoms of anxiety and eating disorder. She had not tried | Upheld | Medical Necessity | Summary Reviewer
The parent of a 15-year-old female enrollee has requested reimbursement and prospective authorization and coverage for mental health residential treatment provided from 2/02/19 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 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 2. The medical records indicate that the patient was not actively suicidal. In terms of functional status, the records support a score of 2. The patient has had some issues with level of function due to mental illness and relational issues, but overall showed appropriate daily functioning while in treatment and indicated prior school functioning was good. In terms of comorbidity, the records support a score of 2. The patient does not have a history of active serious medical issues, and her prior substance use was described to be minimal. With regards to level of stress of the recovery environment, the records support a score of 2. The patient was noted to have a strained relationship with her family and indicated some mild stress at home. In terms of level of support of the recovery environment, the records support a score of 2. The patients parents were involved in treatment. With regards to resiliency and treatment history, the records support a score of 3. The patient had some outpatient mental health therapy prior to her residential admission but continued to have some symptoms of anxiety and eating disorder. She had not tried or failed intensive outpatient forms of treatment for her eating disorder. In terms of acceptance and engagement of the child, the records support a score of 2. The patient has participated in therapy. 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 17. This score correlates with intensive outpatient services. Therefore, mental health residential treatment from 2/02/19 forward was not and is not medically necessary for the treatment of this patient. | 1 |
The patient is a 54-year-old male with a history of left hip pain of two years duration. The pain limits his physical activities including jogging and walking. The pain is anterolateral. There is some intermittent catching. He has tried and failed conservative treatment including physical therapy. On examination, there is a slight antalgic limp. The record notes that his hip range of motion is slightly limited. There is a positive McCarthys sign. FADIR impingement sign is also positive. X-rays show CAM type femoroacetabular impingement. The magnetic resonance (MR) arthrogram dated 9/7/17 showed long standing CAM type femoroacetabular impingement with labral damage. The osteoarthrosis is associated with a subchondral cyst in the acetabulum. The alpha angle is 73 degrees. There is a labral tear as well. The patient reports that he does not want a hip replacement. The provider indicates that the patient meets criteria for arthroscopy of the left hip, labral repair versus debridement and femoroplasty. The Health Insurer has denied the requested services as not medically necessary for the treatment of the patient. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 54-year-old male with a history of left hip pain of two years duration. The pain limits his physical activities including jogging and walking. The pain is anterolateral. There is some intermittent catching. He has tried and failed conservative treatment including physical therapy. On examination, there is a slight antalgic limp. The record notes that his hip range of motion is slightly limited. There is a positive McCarthys sign. FADIR impingement sign is also positive. X-rays show CAM type femoroacetabular impingement. The magnetic resonance (MR) arthrogram dated 9/7/17 showed long standing CAM type femoroacetabular impingement with labral damage. The osteoarthrosis is associated with a subchondral cyst in the acetabulum. The alpha angle is 73 degrees. There is a labral tear as well. The patient reports that he does not want a hip replacement. The provider indicates that the patient meets criteria for arthroscopy of the left hip, labral repair versus debridement and femoroplasty. The Health Insurer has denied the requested services as not medically necessary for the treatment of the patient. This denial is the subject of this appeal and determination. There is support in the medical literature for the requested services in this clinical setting. Femoroacetabular impingement is an important cause of labral tears, chondral lesions, hip pain and a leading cause of early osteoarthritis. Different surgical techniques for the management of femoroacetabular impingement have evolved rapidly over the last decade. The aim of surgery is to correct symptomatic CAM and Pincer abnormalities and reduce secondary osteoarthritis early on; thereby preventing progressive osteoarthritis, while minimizing complications associated with surgery. The medical data indicates that arthroscopic technique has a low complication rate. In this case, the patient has labral tears, CAM type femoroacetabular impingement and early to moderate degenerative changes. The physical findings and MR arthrogram confirm the femoroacetabular impingement and associated damage. The patient has reported gradual worsening of his symptoms. The provider believes that correcting the femoroacetabular impingement with femoroplasty and possibly repairing the torn labrum will likely help the symptoms and slow down the progression of osteoarthritis. A review of the recent medical literature supports the requested services in this patients case. As such, arthroscopy of the left hip, labral repair versus debridement and femoroplasty have been demonstrated as medically necessary for the treatment of this patients medical condition. Therefore, based on the reasons stated above, the requested services are medically necessary for the treatment of this patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 63-year-old male enrollee has requested reimbursement for dopamine transporter imaging with a single proton emission computed tomography (DaT SPECT) scan performed on 8/24/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who presented with persistent hand tremors. | Overturned | Experimental | Summary Reviewer 3A 63-year-old male enrollee has requested reimbursement for dopamine transporter imaging with a single proton emission computed tomography (DaT SPECT) scan performed on 8/24/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who presented with persistent hand tremors. The physician reviewer found that there is a lack of evidence based studies supporting the superior efficacy of the services at issue. The medical literature does not demonstrate that DaT SPECT scan can offer clinical decision making relative to treatment management options in this clinical setting. There remains issues of sensitivity and specificity relative to DaT scans in the diagnosis of Parkinsonian tremor versus other etiologies. Therefore, in this patients case, DaT SPECT performed on 8/24/16 was not likely to be more efficacious than other standard options for the evaluation of this patient. Based upon the information set forth 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 41-year-old female enrollee has requested reimbursement for residential substance use disorder treatment services provided from 8/16/15 through 9/27/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found this patient had a very serious polysubstance addictive illness complicated by the co-occurring diagnoses of generalized anxiety disorder and major depressive disorder in context of enduring characterological issues. Despite prior treatment interventions, the patient was unable to sustain any meaningful sobriety. Her substance use dominated all functional domains and necessitated a complicated detoxification. She had a strained relationship with her significant other and her parents. Despite her impaired insight, the patient was motivated for treatment. Based on the longitudinal history and medical documentation, the patient would have promptly relapsed and required re-admission in the absence of residential programming. | Overturned | Medical Necessity | Summary Reviewer
A 41-year-old female enrollee has requested reimbursement for residential substance use disorder treatment services provided from 8/16/15 through 9/27/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found this patient had a very serious polysubstance addictive illness complicated by the co-occurring diagnoses of generalized anxiety disorder and major depressive disorder in context of enduring characterological issues. Despite prior treatment interventions, the patient was unable to sustain any meaningful sobriety. Her substance use dominated all functional domains and necessitated a complicated detoxification. She had a strained relationship with her significant other and her parents. Despite her impaired insight, the patient was motivated for treatment. Based on the longitudinal history and medical documentation, the patient would have promptly relapsed and required re-admission in the absence of residential programming. Both the services and setting were safe, appropriate and consistent with good practice, while the duration of treatment aligned with community standards. Additionally, the services provided during the disputed timeframe were for active treatment, and 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 services at issue were medically necessary for treatment of the patients behavioral health condition.Therefore, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
The parent of a 15-year-old male enrollee has requested reimbursement for Afirma gene testing provided on 6/16/15. 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
The parent of a 15-year-old male enrollee has requested reimbursement for Afirma gene testing provided on 6/16/15. 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 while a FNA biopsy of a suspicious thyroid nodule is typically an accurate means of assessing whether the nodule is benign or malignant, approximately 15% of FNA biopsy results are considered to be indeterminate (Alexander, et al). Until recently, the only way to establish whether the nodule was in fact thyroid cancer was via surgical excision even though the majority of the cases turn out to be benign (Miller, et al). A relatively new test, the Afirma Thyroid FNA Analysis utilizes a gene expression classifier in order to help determine the likelihood of malignancy of nodules with indeterminate cytology on FNA biopsy, thereby decreasing the need for unnecessary surgeries. Because it is very sensitive and has a high negative predictive value, a negative Afirma result is rather suggestive of a benign nodule and can therefore preclude such surgical procedures (Duick, et al). All told, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned. | 0 |