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A 54-year-old male enrollee has requested authorization and coverage for neurostimulator electrode array and pulse generator. 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 1
A 54-year-old male enrollee has requested authorization and coverage for neurostimulator electrode array and pulse generator. 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 hypoglossal nerve stimulation has been approved by the U.S. Food and Drug Administration for the treatment of moderate to severe obstructive sleep apnea refractory to continuous positive airway pressure. However, research comparing its effectiveness to existing alternatives is lacking. Schwartz and colleagues conducted a systematic review comparing continuous positive airway pressure with mandibular advancement devices in adult patients with mild to severe obstructive sleep apnea. The authors determined that although continuous positive airway pressure improved the apnea-hypopnea index significantly more than mandibular advancement devices, continuous positive airway pressure users also were significantly less compliant with their devices compared to mandibular advancement device users. This discrepancy in usage likely contributed to results showing similar levels of improvement in the interventions across quality of life, cognitive, and functional outcomes. Overall, there is insufficient peer-reviewed evidence to support the use of hypoglossal nerve stimulation over other available therapies. Therefore, CPT codes 64568 and 0466T are not likely to be more beneficial than other treatment options.
| 0 |
patient is a 55-year-old male who presented with symptoms compatible with obstructive
sleep apnea (OSA). The patient has requested reimbursement for an oral device/appliance
provided on 11/12/20. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 55-year-old male who presented with symptoms compatible with obstructive
sleep apnea (OSA). The patient has requested reimbursement for an oral device/appliance
provided on 11/12/20. The physician reviewer found that American Academy of Sleep Medicine
(AASM) guidelines state that oral appliance therapy is an option to treat obstructive sleep apnea
when CPAP therapy is declined or cannot be tolerated. The AASM guidelines state, We
recommend that sleep physicians consider prescription of oral appliances, rather than no
treatment, for adult patients with obstructive sleep apnea who are intolerant of CPAP therapy or
prefer alternate therapy. Therefore, the oral device/appliance provided on 11/12/20 was
medically necessary for the treatment of this patient.
| 1 |
The parent of a nine-year-old transgender male enrollee has requested authorization and coverage for Supprelin LA KIT 50 mg. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees gender dysphoria. | Overturned | Experimental | Summary Reviewer 2
The parent of a nine-year-old transgender male enrollee has requested authorization and coverage for Supprelin LA KIT 50 mg. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees gender dysphoria. The physician reviewer found that there is sufficient support in the medical literature for the requested medication in this clinical setting. It is well established that patients who have gender dysphoria often suffer from psychiatric comorbidities that worsen during puberty, at which time they are at high risk of suicide. Psychiatric comorbidity such as depression, anxiety, and suicidality is common in transgender youth, two to three times more frequent than among cisgender controls. The studies indicate that there is an ideal window of opportunity for patients to receive hormonal intervention, necessitating prompt referrals, which is around sexual maturity rating 2, and not later. Several studies confirm that many of the adverse psychological outcomes noted in transgender youth may be preventable with early recognition, hormonal treatment, and mental health support. There is now strong evidence, for subjects receiving pubertal suppression followed by hormone replacement therapy during adolescence, and gender reassignment surgery in adulthood, that all have improved psychological outcomes and quality of lives compared with those not receiving this therapy. Accordingly, the studies support a benefit with initiation of pubertal blockers in this patients case. As such, Supprelin LA KIT 50 mg is likely to be of greater benefit for treatment of this patients medical condition than the available standard methods. 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 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 records document an apnea-hypopnea index of 22.3. The patient has been unable to tolerate continuous positive airway pressure. | Overturned | Experimental | Summary Reviewer 3
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 medical evidence supports the requested services in this patients case. The records document an apnea-hypopnea index of 22.3. The patient has been unable to tolerate continuous positive airway pressure. Clinical studies of the use of hypoglossal nerve stimulation indicate that patients benefit from this device when they have a body mass index (BMI) less than 32. This patient has a BMI of 21.3. Per the medical evidence, selective upper airway stimulation is a safe and effective therapy for patients with obstructive sleep apnea and represents a powerful option for its surgical treatment. Woodson and colleagues noted long-term improvements and demonstrated that adverse events were uncommon. Thus, the requested hypoglossal nerve stimulation (64568 and 0466T) is likely to be more effective than other treatment options.
| 1 |
The patient is a 66-year-old male who presented with lower urinary tract symptoms. The
patient has requested reimbursement for MRI of pelvis performed on 11/08/21.
This case was previously reviewed, and the patient submitted additional
documentation for reconsideration.
However, in this case,
the patient had an elevated PSA level in the setting of a urinary tract infection. This had
normalized after antibiotic treatment.
had normalized to 3.69 by 10/20/21, and his
digital rectal examination was | Upheld | Medical Necessity | Summary Reviewer
The patient is a 66-year-old male who presented with lower urinary tract symptoms. The
patient has requested reimbursement for MRI of pelvis performed on 11/08/21. The physician
reviewer found that the submitted documentation fails to demonstrate the medical necessity
of the services at issue. This case was previously reviewed, and the patient submitted additional
documentation for reconsideration. According to the American Urological Association Standard
Operating Procedure referenced below, there is level 1 data to support the recommendation of
multiparametric MRI prior to biopsy for all men without a previous history of biopsy who are
under consideration for prostate biopsy. Per the AUA, Multiparametric MRI-targeted prostate
biopsy in men at suspicion of prostate cancer, with no previous history of prostate cancer,
detects more clinically significant prostate cancer when combined with systematic biopsy, and
less clinically insignificant prostate cancer, than systematic biopsy alone. However, in this case,
the patient had an elevated PSA level in the setting of a urinary tract infection. This had
normalized after antibiotic treatment. Additionally, digit rectal examination was normal. There
was no suspicion about prostate cancer. Performing an MRI would not be considered a clinically
appropriate and generally accepted standard for management of this patients medical
condition. There are indications for performing MRIs based on the risk of prostate cancer. If a
patient has an elevated PSA and/or abnormal digital rectal examination, an MRI may be
indicated. As noted above, this patients PSA had normalized to 3.69 by 10/20/21, and his
digital rectal examination was normal. The additional documentation provided for
reconsideration did not alter the original determination. Therefore, MRI of pelvis performed on
11/08/21 was not medically necessary for the evaluation of this patient.
| 1 |
A 32-year-old female enrollee has requested reimbursement for prenatal testing performed on 1/10/14. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees suspected fetal abnormality. | Overturned | Experimental | Summary Reviewer 1
A 32-year-old female enrollee has requested reimbursement for prenatal testing performed on 1/10/14. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees suspected fetal abnormality. The physician reviewer found, while cell-free fetal DNA testing is a very effective screening test for women at high risk for fetal trisomy, the use of this test for lower risk women has not been established. The American Congress of Obstetricians and Gynecologists (ACOG) currently states Given the performance of conventional screening methods, the limitations of cell-free DNA screening performance, and the limited data on cost-effectiveness in the low-risk obstetric population, conventional screening methods remain the most appropriate choice for first-line screening for most women in the general obstetric population. Since this patients risk of Down syndrome at the time of testing was appropriately assessed as 1:5,000, she would not be classified as at high-risk for fetal trisomy. The data underlying this recommendation comes from the Non-Invasive Chromosomal Evaluation (NICE) Study that only included patients with an increased risk of fetal aneuploidy, with a presumed prevalence of trisomy 21 of 1:50 in their cohort. More recent studies on cell-free DNA testing in a low risk or routine population has confirmed [cell-free DNA] cfDNA testing was superior to that of traditional first-trimester screening for the detection of trisomy 21 in a routine prenatal population, but indicates further study is still needed (Norton, et al (2015). Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 60-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 10/10/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. | Upheld | Experimental | Summary Reviewer 3
A 60-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 10/10/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that 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. The test is novel, and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. Thus, DecisionDx-Melanoma testing performed on 10/10/19 was not likely to have been more beneficial than any available standard therapy.
| 0 |
A 41-year-old male enrollee has requested reimbursement for elastase pancreatic fecal and fecal calprotectin laboratory testing performed on 8/03/18. 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 records document diarrhea-predominant irritable bowel syndrome. This patients provider ordered fecal calpr | Upheld | Experimental | Summary Reviewer 1
A 41-year-old male enrollee has requested reimbursement for elastase pancreatic fecal and fecal calprotectin laboratory testing performed on 8/03/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that there is a lack of support for the services at issue in this clinical setting. The records document diarrhea-predominant irritable bowel syndrome. This patients provider ordered fecal calprotectin testing to rule out intestinal inflammation and fecal elastase testing to assess for pancreatic insufficiency. Based on the records, careful patient interview and examination may have yielded better targeted studies. In the evaluation of chronic diarrhea, fecal calprotectin is sometimes used in clinical practice to distinguish inflammatory versus functional causes of diarrhea, particularly in pediatric populations. The records do not support concern for inflammatory bowel disease in this patients case. Therefore, fecal calprotectin laboratory testing performed on 8/03/18 was not likely to have been superior over other methods of evaluating this patient.
| 1 |
A 38-year-old male enrollee has requested reimbursement for polymerase chain reaction testing for gastrointestinal pathogen panel performed on 12/16/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
records indicate that the patient had limited comorbidities at the time of the disputed testing, and that his diarrheal condition was self-limited and uncomplicated. | Upheld | Experimental | Summary Reviewer 2
A 38-year-old male enrollee has requested reimbursement for polymerase chain reaction testing for gastrointestinal pathogen panel performed on 12/16/19. 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 there is a lack of support for the services at issue in this clinical setting. The submitted records indicate that the patient had limited comorbidities at the time of the disputed testing, and that his diarrheal condition was self-limited and uncomplicated. Provided documentation fails to support fever, dysentery, severe dehydration, or that patient is an immunocompromised individual. Rather, the patientas record supports immunocompetency, no blood in stool, and a clinical history suggestive of a narrowly-focused infectious etiology. The medical evidence does not support the services at issue over otherwise targeted stool analysis for this patientas condition. Therefore, polymerase chain reaction testing for gastrointestinal pathogen panel performed on 12/16/19 was not likely to have been more beneficial than other available methods of evaluating this patient.
| 1 |
The parent of a six-year-old male enrollee has requested authorization and coverage for Saizen 8.8 mg click easy cartridge. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees medical condition
this patient was born small for gestational age and has failed to catch up in weight and length since birth. He has low growth factors and a small pituitary gland as well. | Overturned | Experimental | Summary Reviewer 2
The parent of a six-year-old male enrollee has requested authorization and coverage for Saizen 8.8 mg click easy cartridge. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees medical condition The physician reviewer found this patient was born small for gestational age and has failed to catch up in weight and length since birth. He has low growth factors and a small pituitary gland as well. Per the medical evidence, sustained postnatal growth failure in children who have been small for gestational age is considered an indication for growth hormone treatment in children. Provocative growth hormone testing is not required for diagnosis and treatment for this indication. Therefore, the requested Saizen 8.8 mg click easy cartridge is likely to be more effective than other treatment options. Based upon the information set forth above, the requested medication is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 22-year-old female enrollee has requested reimbursement for the blood testing (Prometheus Anser IFX) performed on 4/26/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found the patient is a 22-year-old female with stenotic ileocolonic and perianal Crohns disease diagnosed in 2012. She has been maintained on Remicade therapy since 2012, with doses varying from 5 mg/kg every eight weeks to 10 mg/kg every four weeks. Remission was achieved in January 2013. Per the office note dated 3/2/16, the patient was experiencing no gastrointestinal symptoms, had no active perianal disease or bleeding, and stools were formed and 1-2 per day in the setting of a normal C-reactive protein. On 4/28/16 Prometheus Anser IFX testing showed detectable serum infliximab (8.7 ug/mL, reference <1.0) and undetectable antibodies to infliximab (<3.1 U/mL). The patient has requested reimbursement for blood testing (Prometheus Anser IFX) performed on 4/26/16. The Health Insurer has denied this request as investigational. | Upheld | Experimental | Summary Reviewer 1
A 22-year-old female enrollee has requested reimbursement for the blood testing (Prometheus Anser IFX) performed on 4/26/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found the patient is a 22-year-old female with stenotic ileocolonic and perianal Crohns disease diagnosed in 2012. She has been maintained on Remicade therapy since 2012, with doses varying from 5 mg/kg every eight weeks to 10 mg/kg every four weeks. Remission was achieved in January 2013. Per the office note dated 3/2/16, the patient was experiencing no gastrointestinal symptoms, had no active perianal disease or bleeding, and stools were formed and 1-2 per day in the setting of a normal C-reactive protein. On 4/28/16 Prometheus Anser IFX testing showed detectable serum infliximab (8.7 ug/mL, reference <1.0) and undetectable antibodies to infliximab (<3.1 U/mL). The patient has requested reimbursement for blood testing (Prometheus Anser IFX) performed on 4/26/16. The Health Insurer has denied this request as investigational. The blood testing (Prometheus Anser IFX) performed on 4/26/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The clinical utility of measuring drug antibody concentrations has not been established, and it has not been established how patient management would change based on test results. The American Gastroenterological Association (AGA) guideline recommendations on therapeutic drug monitoring in patients with inflammatory bowel disease acknowledged that there exists no defined cut-offs by which to judge low versus high titer anti-drug antibodies. In this case, the provided records do not support that the patients Crohns disease was symptomatically active at the time of the Prometheus Anser IFX testing. As such, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 62-year-old female has requested authorization and coverage for spine nerve treatment. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees back pain. | Upheld | Experimental | Summary Reviewer 2
A 62-year-old female has requested authorization and coverage for spine nerve treatment. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees back pain. The physician reviewer found in the documentation available for review, the provider does not document a pain diary for the medial branch block done prior to the radiofrequency ablation. The literature is clear regarding how a diagnostic medial branch block should be done prior to radiofrequency ablation; specifically, using a pain diary for the day to verify when the local anesthetic wore off. Moreover, it is possible the patient would experience the same relief from a steroid injection alone without also having the increased risk from the radiofrequency ablation. No mention of prior failure from facet injections or epidural injections is noted. Therefore, the requested spine nerve treatment is not likely to be more beneficial for treatment of the patients medical condition than other treatment alternatives. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
The parent of a 15-year-old female enrollee has requested reimbursement and prospective authorization and coverage for intensive outpatient program (IOP) mental health care services provided from 11/9/16 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health issues.
The records report that the patients overall mood had improved, and there was no documentation of self-harming behavior. The patient continues to have frequent mood dysregulation which appears to be a chronic issue.
. The provider recommended the patient engage in dialectical behavioral therapy (DBT) and seek a specialist to help with the patients mood dysregulation. Thus, the records indicate that the patient was a candidate for | Upheld | Medical Necessity | Summary Reviewer
The parent of a 15-year-old female enrollee has requested reimbursement and prospective authorization and coverage for intensive outpatient program (IOP) mental health care services provided from 11/9/16 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health issues. The physician reviewer found that the documentation provided for review provides insufficient evidence to support that IOP treatment from 11/9/16 forward was not and is not medically necessary for treatment of this patients medical condition. The records report that the patients overall mood had improved, and there was no documentation of self-harming behavior. The patient continues to have frequent mood dysregulation which appears to be a chronic issue. However, there is a lack of data supporting the efficacy of further IOP treatment for her chronic mood dysregulation. There is no indication that she was or is having any medical problems from anorexia nervosa that require frequent monitoring. The provider recommended the patient engage in dialectical behavioral therapy (DBT) and seek a specialist to help with the patients mood dysregulation. Thus, the records indicate that the patient was a candidate for treatment as an outpatient. All told, IOP mental health care services provided from 11/9/16 forward were not and are not medically necessary for treatment of this patients anorexia nervosa, major depressive disorder, and social anxiety disorder. Based on the foregoing discussion, the services at issue were not and are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
The patient is a 32-year-old male. Per the history and physical note dated 5/31/21, he had recurrent
small bowel obstruction thought to be due to Crohns disease, and presented with increasing
abdominal pain and distention since the prior evening. The patient has requested reimbursement
for inpatient services provided from 5/31/21 through 6/02/21. The Health Insurer has denied this
request and reported that the services at issue were not medically necessary for the treatment of
this patient.
. The patient presented with abdominal pain and imaging
findings consistent with low-grade or partial small bowel obstruction. He had improvement in
symptoms with conservative therapy. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 32-year-old male. Per the history and physical note dated 5/31/21, he had recurrent
small bowel obstruction thought to be due to Crohns disease, and presented with increasing
abdominal pain and distention since the prior evening. The patient has requested reimbursement
for inpatient services provided from 5/31/21 through 6/02/21. The Health Insurer has denied this
request and reported that the services at issue were not medically necessary for the treatment of
this patient. This denial is the subject of this appeal and determination. The physician reviewer
found that the submitted documentation fails to demonstrate the medical necessity of the services
at issue. The inpatient level of care was not supported, and the care provided could have been
provided at the observation level of care. The patient presented with abdominal pain and imaging
findings consistent with low-grade or partial small bowel obstruction. He had improvement in
symptoms with conservative therapy. Imaging did not show bowel ischemia, and no other
gastrointestinal cause for the inpatient level of care, such as gastrointestinal bleeding, peritonitis,
toxic megacolon, sepsis, abscess, or other complication was documented. He regained tolerance
of oral intake without surgical intervention. All of the measures that were undertaken, including
monitoring, laboratory testing, specialist consultations, colonoscopy, and advancement of diet,
could have been performed without the inpatient level of care, at the observation level of care.
Therefore, inpatient services provided from 5/31/21 through 6/02/21 were not medically necessary
for the treatment of this patient.
| 1 |
A 66-year-old male enrollee has requested reimbursement for gene expression profiling of melanomas performed on 3/29/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. | Upheld | Experimental | Summary Reviewer 3
A 66-year-old male enrollee has requested reimbursement for gene expression profiling of melanomas performed on 3/29/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that melanoma is a cancer that is curable in its earliest stages. Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for patients with high depth of invasion, 0.76 to 1.0 mm. Metastases to regional lymph nodes may be amenable to excision, but this suggests a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha. The data on the 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 very novel, and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. Thus, gene expression profiling of melanomas performed on 3/29/18 was not likely to be 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.
| 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. | Upheld | Experimental | Summary Reviewer 3
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 scientific evidence has not been established via well-designed controlled studies with adequate follow-up demonstrating safety and efficacy of the use of the LINX procedure. Evidence arises largely from case series and cohort studies. Direct comparative studies between surgical interventions are needed to better assess the long-term safety and efficacy of this therapeutic intervention in patients. There is lack of randomized controlled trials comparing LINX with other surgical anti-reflux interventions, such as the Nissen fundoplication. Sheu and Rattner concluded that the long-term safety and efficacy of LINX remains to be determined by evaluating and investigating the safety, efficacy and durability of the intervention over time. Adverse events including erosion through the esophagus have been reported in particular cases. The LINX procedure has not been rigorously tested in randomized controlled trials against other alternative therapies. The superior efficacy of the requested services has not been established. Therefore, CPT 43284 (magnetic sphincter augmentation) is not likely to be more beneficial than any available standard therapy.
| 0 |
A 31-year-old female enrollee has requested authorization and coverage for HyQvia. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hypogammaglobulinemia. | Overturned | Medical Necessity | Summary Reviewer
A 31-year-old female enrollee has requested authorization and coverage for HyQvia. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hypogammaglobulinemia. The physician reviewer found that HyQvia Ig, dosed at once per month infusion intervals, meets the medical necessity criteria for this patient, who has a diagnosis of blood clotting disorder and hypogammaglobulinemia. In the case of this patient, her blood clotting disorder places her at an increased baseline risk for thromboembolic events. Thus, it is clinically reasonable that less frequent dosing intervals would place her at a lower risk for thromboembolic events. It is also clinically reasonable that a less concentrated Ig product, such as HyQvia, poses less of a risk for thromboembolic event. The peer-reviewed literature does support the use of Ig replacement in special circumstances, such as with this patient. The literature advises also for adequate hydration pre-Ig infusions, slowed infusion rates, and use of antiplatelet therapy for patients at risk. Given this patients clinical presentation and history, the requested HyQvia is medically necessary. Based on the foregoing discussion, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned. | 1 |
A 46-year-old female enrollee has requested reimbursement for substance abuse residential treatment provided from 6/16/18 through 6/24/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions.
, the patients abuse of alcohol and alprazolam was impairing her daily routine and contributing to significant impairment across multiple domains of functionality. Her addictive illness, and co-o
. The patient was motivated for recovery. Although she was unsure of the viability of the marriage, she had a safe environment conducive to recovery and supportive family. The physician note from 6/7/18 was unremarkable. The patient was mildly anxious, but stable affectively. Her laboratory studies were normal. There was no mention of distress or problems with her medications, which by then included an anti-craving medication, naltrexone. | Upheld | Medical Necessity | Summary Reviewer
A 46-year-old female enrollee has requested reimbursement for substance abuse residential treatment provided from 6/16/18 through 6/24/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found that in this case, the patients abuse of alcohol and alprazolam was impairing her daily routine and contributing to significant impairment across multiple domains of functionality. Her addictive illness, and co-occurring depression, warranted specialty care. However, by mid-June 2018, there was no evidence of a withdrawal syndrome, psychosocial scenario, psychiatric condition or medical illness that would typically require treatment at the residential level of care. The patient was motivated for recovery. Although she was unsure of the viability of the marriage, she had a safe environment conducive to recovery and supportive family. The physician note from 6/7/18 was unremarkable. The patient was mildly anxious, but stable affectively. Her laboratory studies were normal. There was no mention of distress or problems with her medications, which by then included an anti-craving medication, naltrexone. Further, the patient was not actively engaged in psychiatric care prior to admission, and she had no history of substance use specific chemical dependency treatment, such as outpatient counseling, medication assisted therapy, intensive outpatient services, partial hospitalization or placement in a sober living environment. Modern psychiatric practice favors treatment in the community as outcome measures and therapeutic gains are optimized in this environment. There was no evidence to suggest that similarly comprehensive, evidence-based services provided in a less restrictive treatment setting for this stable, motivated and otherwise healthy patient would have been insufficient or inadequate at the time. All told, substance abuse residential treatment provided from 6/16/18 through 6/24/18 were not medically necessary for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
The parent of a 14-year-old male enrollee has requested reimbursement for residential mental health services provided from 2/8/16 through 7/7/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health issues.
24-hour supervision. He did not have any homicidal or suicidal ideation, there was no evidence that he was a danger to himself or others, and the patient was medically stable. It is noted that during the residential stay, there were few medication changes and his parent consulted with the patients outpatient psychiatrist for all medication changes. The patient could have been treated by the outpatient psychiatrist for any medication changes. | Upheld | Medical Necessity | Summary Reviewer
The parent of a 14-year-old male enrollee has requested reimbursement for residential mental health services provided from 2/8/16 through 7/7/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health issues. The physician reviewer found that per the documentation, the services provided for the RTC included individual therapy once a week, group therapy five times a week, and family therapy once a week. However, the same services could have been provided in a less restrictive treatment environment. The patient did not require 24-hour supervision. He did not have any homicidal or suicidal ideation, there was no evidence that he was a danger to himself or others, and the patient was medically stable. It is noted that during the residential stay, there were few medication changes and his parent consulted with the patients outpatient psychiatrist for all medication changes. The patient could have been treated by the outpatient psychiatrist for any medication changes. Due to the patients autism spectrum disorder, it is likely that his impulsivity will remain a consistent symptom. Prior RTC care did not report that they made much improvement with the patients impulsivity and inappropriate behavior. The expectation as noted in the documentation was that there would be minimal improvement with the patients impulsivity and inappropriate behavior. Therefore, the RTC mental health services provided from 2/8/16 through 7/7/16 were not medically necessary as there was not a reasonable expectation that RTC treatment services would improve the patients problems. Based on the available records, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 58-year-old female enrollee has requested reimbursement and prospective authorization and coverage for chemical dependency residential treatment services provided from 10/29/18 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 post-traumatic stress disorder (PTSD).
On 1/02/19, the patients mood had improved. She had slept well. On this date, therapy continued delving into her history of sexual trauma. The records noted the connection between childhood sexual trauma and substance use. Based on the clinical notes, the patient remained at risk of relapse. Patients conditions wax and wane. | Overturned | Medical Necessity | Summary Reviewer
A 58-year-old female enrollee has requested reimbursement and prospective authorization and coverage for chemical dependency residential treatment services provided from 10/29/18 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 post-traumatic stress disorder (PTSD). The physician reviewer found that the submitted documentation supports the medical necessity of the services at issue. On 1/02/19, the patients mood had improved. She had slept well. On this date, therapy continued delving into her history of sexual trauma. The records noted the connection between childhood sexual trauma and substance use. Based on the clinical notes, the patient remained at risk of relapse. Patients conditions wax and wane. A relatively positive documentation on one day does not indicate spontaneous cure. Rather, this denotes progress and that the treatment is working, which is an indication to continue treatment. The American Psychiatric Association treatment guidelines note that residential treatment or similar care higher than outpatient is indicated for patients who do not meet the clinical criteria for hospitalization but whose lives and social interactions have come to focus predominantly on substance use and who lack sufficient social and vocational skills and drug-free social supports to maintain abstinence in an outpatient setting. This patient requires a safe and stable living environment in order to develop her recovery skills. The purpose of detoxification is to make the patient physically stable and safe. Rehabilitation is an essential component that should follow detoxification to help the patient maintain sobriety and reduce risk of relapse. Given the severity of the patients illness and need for detoxification as well as risk factors such as trauma history, residential treatment was and is in accordance with generally accepted standards of medical practice. The current medical evidence supports the services at issue in this clinical setting. Therefore, chemical dependency residential treatment provided from 10/29/18 forward was and is medically necessary for the treatment of this patient. | 1 |
A 64-year-old female has requested reimbursement for FoundationOne testing performed on 1/13/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 3
A 64-year-old female has requested reimbursement for FoundationOne testing performed on 1/13/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found there is sufficient support for the services at issue in this patients case. The study by Von Hoff and colleagues evaluated 86 patients, and the progression-free survival on the regimen selected by molecular profiling was compared to the progression-free survival on the last chemotherapy regimen. The regimen selected by molecular profiling offered a 27% survival advantage. This trial has very significant results for patients with stage IV tumors. In this clinical setting, the results from molecular profiling may offer a rational selection of the next regimen. Therefore, FoundationOne testing performed on 1/13/16 was likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 0 |
A 66-year-old male enrollee has requested reimbursement for the unlisted chemistry procedure (84999) Prometheus Anser testing performed on 12/22/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Crohns disease.
this case, Anser testing was ordered to direct the management of the patients Crohns disease. | Upheld | Experimental | Summary Reviewer 2
A 66-year-old male enrollee has requested reimbursement for the unlisted chemistry procedure (84999) Prometheus Anser testing performed on 12/22/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found in this case, Anser testing was ordered to direct the management of the patients Crohns disease. The use of Anser testing has not been clinically proven to improve patient clinical outcomes, and has not definitively demonstrated clinical utility. The effectiveness of Anser testing compared with conventional courses of action remains unproven. Patients being treated with adalimumab may experience loss of response, but the appropriate method for determination of the cause for loss of response is not clear. The published studies on the use of anti-adalimumab antibodies and serum levels are retrospective and/or observational in nature (Karmiris, et al; Imaeda, et al; Lichtenstein, et al). These small studies demonstrate correlations between treatment failure and the presence of anti-adalimumab antibodies, which do not allow firm conclusions regarding cause and effect. The study by Karmiris and colleagues found no direct relationship between trough serum adalimumab concentration or anti-adalimumab antibody and short-term treatment efficacy. Prospective controlled trials providing evidence for the effectiveness of anti-adalimumab antibody testing and serum level testing as part of a clinical management strategy are lacking. A review article concluded that Prospective controlled trials are directly needed to investigate the optimal tailored management in individual patients who lose response (Yanai and Hanauer). Therefore, clinical literature does not support Anser testing as definitively likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 43-year-old female enrollee has requested authorization and coverage for immune globulin injection 500 mg (Gamunex-C). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.
The records document a history of recurrent spontaneous pregnancy loss. Per the provider, the patient has been diagnosed with polyclonal hypergammaglobulinemia, white blood cell disorder, and coagulation disorder hereditary thrombophilia. She is currently pregnant, and her provider has recommended intravenous immune globulin (IVIG) (Gamunex-C) to prevent fetal loss. | Upheld | Experimental | Summary Reviewer 3
A 43-year-old female enrollee has requested authorization and coverage for immune globulin injection 500 mg (Gamunex-C). 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 services at issue. The records document a history of recurrent spontaneous pregnancy loss. Per the provider, the patient has been diagnosed with polyclonal hypergammaglobulinemia, white blood cell disorder, and coagulation disorder hereditary thrombophilia. She is currently pregnant, and her provider has recommended intravenous immune globulin (IVIG) (Gamunex-C) to prevent fetal loss. The current literature does not support the services at issue in this patients case. The treatment of IVIG has not been shown to improve pregnancy outcomes. Thus, immune globulin injection (Gamunex-C), 500 mg is not likely to be more effective than other treatment options.
| 1 |
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. | Overturned | Experimental | Summary Reviewer 2
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 patients case. Lumbar medial branch radiofrequency ablation or neurolysis is a well-documented procedure which may help with chronic low back pain due to lumbar facet pain. The medical records support the services at issue in this clinical setting. The literature has noted the effectiveness of medial branch radiofrequency neurotomy in systematic reviews and randomized trials. In sum, the services at issue performed on 12/02/13 and 12/23/13 were likely to have been more effective than other treatment options. 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 73-year-old male requested reimbursement for genetic testing performed on 9/26/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees cutaneous melanoma.
that the patient is a 73-year-old male with a recurrent squamous cell carcinoma of the scalp diagnosed in 2016 and now with suspected dural invasion. Prior treatment has included multiple Mohs procedures, cetuximab, temsirolimus, and Avastin. His medical history is complicated by heart and kidney transplants for which he is on chronic suppression. FoundationOne testing was sent on 9/26/16 to help guide therapeutic decision making. The patient requested reimbursement for genetic testing performed on 9/26/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational.T | Upheld | Experimental | Summary Reviewer 3
A 73-year-old male requested reimbursement for genetic testing performed on 9/26/16. 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 patient is a 73-year-old male with a recurrent squamous cell carcinoma of the scalp diagnosed in 2016 and now with suspected dural invasion. Prior treatment has included multiple Mohs procedures, cetuximab, temsirolimus, and Avastin. His medical history is complicated by heart and kidney transplants for which he is on chronic suppression. FoundationOne testing was sent on 9/26/16 to help guide therapeutic decision making. The patient requested reimbursement for genetic testing performed on 9/26/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational.The National Comprehensive Cancer Network (NCCN) panel encourages participation in a clinical trial for patients with metastatic squamous cell carcinoma. FoundationOne testing helps guide eligibility for clinical trials and help determine eligibility for compassionate use of PDL-1 inhibitors should the tumor express molecular markers indicating likelihood of efficacy. This patients course has been complicated by the use of immunosuppressive medications for his heart and kidney transplant. Accordingly, the genetic testing performed on 9/26/16 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 45-year-old female enrollee has requested reimbursement for the breast tomosynthesis performed on 10/22/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
, the patient has breasts that have been described as being heterogeneously dense. | Overturned | Experimental | Summary Reviewer 3
A 45-year-old female enrollee has requested reimbursement for the breast tomosynthesis performed on 10/22/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that Tomosynthesis is a technique that was developed as a problem solving adjunct to routine mammography. Applying the same basic concept as computed tomography (CT) scanning, the logic is that by separating the various layers of breast tissue, one can better detect abnormalities. This has been shown to be most useful in the evaluation of the dense breast tissue. In this case, the patient has breasts that have been described as being heterogeneously dense. Furthermore, the presence of dense breast tissue is an indication for tomosynthesis. The ability to separate out the overlapping structures enables the possibility of demonstrating an otherwise occult tumor. Based on the clinical documentation submitted for review, the breast tomosynthesis performed on 10/22/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 41-year-old male enrollee has requested reimbursement for Decision DX Melanoma Assay performed on 12/16/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma.
the pathology report in this case listed his stage as pT1b, it appears that in the absence of ulceration, and a penetration only to Clark Level III, he is really stage pT1a. | Upheld | Experimental | Summary Reviewer 2
A 41-year-old male enrollee has requested reimbursement for Decision DX Melanoma Assay performed on 12/16/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found there is a lack of support for the services at issue in this clinical setting. The prognosis of cutaneous melanoma has classically been determined by the staging system spelled out by Balch. Mitotic index has also been thought to add a bit more to the prognostics. Although the pathology report in this case listed his stage as pT1b, it appears that in the absence of ulceration, and a penetration only to Clark Level III, he is really stage pT1a. By these determinations, he has at least a 95% five-year and 88% ten-year survival. Decision DX Melanoma Assay is a study of 31 genes in the melanoma cells. It then classifies that particular melanoma as either class 1 (with a 97% disease free rate at five years) or class 2 (with a 31% disease free rate at five years). Gerami reported that there was good correlation between prognosis and Decision DX classification. However, it is not clear how Decision DX Melanoma Assay data compares to the ten-year data of Balch determinations, and whether it can be used prospectively in clinical practice. This is especially in question in this particular patient with his pathologic findings and excellent prognosis. In sum, Decision DX Melanoma Assay performed on 12/16/15 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 59-year-old male enrollee has requested reimbursement for advanced lipoprotein testing provided on 3/11/16. The Health Plan has denied this request indicating that the service at issue was considered investigational for the enrollees hypertension.T | Upheld | Experimental | Summary Reviewer 2
A 59-year-old male enrollee has requested reimbursement for advanced lipoprotein testing provided on 3/11/16. The Health Plan has denied this request indicating that the service at issue was considered investigational for the enrollees hypertension.The physician reviewer found that based on the documentation provided for review the patient presents with significant cardiovascular risk, including diabetes. In this circumstance guidelines for the management of cardiac risk and dyslipidemia have been established, are periodically updated by expert committees and are endorsed by several national organizations. These guidelines currently do not recommend routine performance of specialized tests in the context of assessing coronary risk (Greenland, et al; Stone, et al). Treatment change or addition based on the results of screening with these specialized tests has not been shown to improve cardiac outcome incremental to that achievable by treatment based on standard risk factor profiling and basic lipid analysis. Although results of some of these specialized tests may be abnormal and considered independent risk markers for coronary disease, there are is a lack of controlled trials that demonstrate outcome benefits by treating routinely obtained abnormal results. Accordingly, the advanced lipoprotein testing provided on 3/11/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 60-year-old male has requested reimbursement for gene testing provided on 11/07/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. | Upheld | Experimental | Summary Reviewer 2
A 60-year-old male has requested reimbursement for gene testing provided on 11/07/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that there is a lack of support for the services at issue in this clinical setting. The results of this testing were unlikely to have altered treatment recommendations. There is a paucity of evidence from the literature that tailored follow-up according to these test results has an impact on long-term outcomes. Furthermore, prospective randomized studies to determine recurrence risk is lacking for this test. In sum, gene testing provided on 11/07/17 was not likely to have been superior over other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 28-year-old male enrollee has requested authorization and coverage for Genium x 3 (military grade) microprocessor K3 knee. The Health Insurer has denied this request and reported that the requested device is not medically necessary for the treatment of this patient. | Upheld | Medical Necessity | Summary Reviewer
A 28-year-old male enrollee has requested authorization and coverage for Genium x 3 (military grade) microprocessor K3 knee. The Health Insurer has denied this request and reported that the requested device is not medically necessary for the treatment of this patient. The physician reviewer found that the current medical evidence does not support the requested device in this clinical setting. The requested device, a microprocessor-controlled prosthetic knee, is not of proven marginal clinical benefit over a conventional prosthetic knee without microprocessor control. The contention that this type of device affords significant functional benefits is largely anecdotal or industry-generated/supported. A clinical trial by Meier and colleagues showed higher performance with a passive prosthetic knee (Mauch SNS) versus the microprocessor-controlled C-Leg. The authors postulated that a simpler knee joint could perform better than a microprocessor-aided prosthetic knee on soft or uneven surfaces because users have a more expedient and direct impact on the knees behavior over a microprocessor-aided knee. More recent high-grade literature establishing a clinically significant functional improvement using this technology has not been published. Therefore, the requested Genium x 3 (military grade) microprocessor K3 knee is not medically necessary for the treatment of this patient. | 1 |
A 57-year-old male enrollee has requested authorization and coverage for PET imaging (78816). The Health Insurer has denied this request and reported that the requested services are not medically necessary for the evaluation of the enrollees medical condition. | Upheld | Medical Necessity | Summary Reviewer
A 57-year-old male enrollee has requested authorization and coverage for PET imaging (78816). The Health Insurer has denied this request and reported that the requested services are not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that the management of incidentally discovered cystic pancreatic lesions depends on multiple factors, including size, morphology/location, presence of a solid component, communication with the pancreatic duct and the presence of high-risk features. Depending on these characteristics, appropriate management could include surgical resection, biopsy (if amenable) or serial follow-up imaging. In this case, the computed tomography scan could not determine if this lesion communicates with the pancreatic duct. The next appropriate imaging test would be magnetic resonance imaging/magnetic resonance cholangiopancreatography to assess ductal relationship and therefore determine follow-up and further management. The medical evidence does not support the requested services in this clinical setting at this time. Therefore, PET imaging (78816) is not medically necessary for the evaluation of this patient. | 0 |
1A 56-year-old male enrollee has requested reimbursement for FoundationOne testing performed on 3/14/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees recurrent myxofibrosarcoma. | Overturned | Experimental | Summary Reviewer 1A 56-year-old male enrollee has requested reimbursement for FoundationOne testing performed on 3/14/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees recurrent myxofibrosarcoma. The physician reviewer found that Currently recognized and accepted molecular evaluation and classification of soft tissue sarcoma (STS) include standard histological evaluation (National Comprehensive Cancer Network guidelines). Broad genomic panel testing such as FoundationOne is not considered standard therapy. In general, to demonstrate clinical utility of panel genetic testing, such as FoundationOne, prospective randomized clinical trials are needed that compare the strategy of targeted treatment based on panel results with standard of care. There is currently a lack of such trials that have been published. The available literature on clinical utility consists of a small number of uncontrolled studies, and nonrandomized controlled trials that use imperfect comparators. This evidence is not sufficient to make any conclusions as to its clinical utility in this patients case. In addition, there is potential for harm if ineffective therapy is given based on test results, because there may be adverse effects of therapy in absence of a benefit. As a result, the use of expanded mutation panel testing for targeted treatment in cancer is considered unproven and should only be conducted in the setting of a clinical trial. Accordingly, FoundationOne testing performed on 3/14/17 was not likely have been of greater benefit than the standard options available for the evaluation of this patients medical condition. Therefore, for the reasons stated above, the services at issue were not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
The parent of a five-year-old male enrollee has requested reimbursement for the comparative genomic hybridization (CGH) FirstStep DX Plus testing performed on 10/15/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 3
The parent of a five-year-old male enrollee has requested reimbursement for the comparative genomic hybridization (CGH) FirstStep DX Plus testing performed on 10/15/15. 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 services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The medical literature supports CGH to be performed as the initial investigative tool for evaluating children with developmental delay (Michelson, et al). CGH is well established as the initial assessment study for any developmentally delayed child. The testing at issue was clinically indicated as it is the most effective tool available for establishing an etiology in this clinical setting. For the reasons provided, the comparative genomic hybridization (CGH) FirstStep DX Plus testing performed on 10/15/15 was likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 0 |
A 44-year-old male enrollee has requested reimbursement for nasopharyngoscopy, surgical, with
dilation of eustachian tube (i.e. balloon dilation); bilateral on 7/6/21. The Health Insurer has denied
this request and reported that the service at issue was investigational for the treatment of the
enrollees bilateral chronic eustachian tube dysfunction.
. In this case, the patient
had a history of ear pressure and had undergone bilateral myringotomy with tube placement
without improvement. A balloon eustachian tuboplasty resolved his symptoms. | Overturned | Experimental | Summary Reviewer 1
A 44-year-old male enrollee has requested reimbursement for nasopharyngoscopy, surgical, with
dilation of eustachian tube (i.e. balloon dilation); bilateral on 7/6/21. The Health Insurer has denied
this request and reported that the service at issue was investigational for the treatment of the
enrollees bilateral chronic eustachian tube dysfunction. The physician reviewer found that the Anand
and colleagues report that balloon eustachian tuboplasty shows efficacy at a follow-up of one year
with the combination of balloon dilation and medical management resulting in improved
eustachian tube dysfunction symptoms versus medical management alone. In this case, the patient
had a history of ear pressure and had undergone bilateral myringotomy with tube placement
without improvement. A balloon eustachian tuboplasty resolved his symptoms. In this clinical
setting, the balloon eustachian tuboplasty, which provides long-term relief, was likely to have been
more beneficial than standard therapies that only provide short-term relief. Therefore,
nasopharyngoscopy, surgical, with dilation of eustachian tube (i.e. balloon dilation); bilateral on
7/6/21 was likely to have been more beneficial for treatment of the patients condition than any
available standard therapy.
| 1 |
A 29-year-old female enrollee has requested reimbursement for allergen specific immunoglobulin G (IgG) (RAST/ELISA) for routine allergy testing performed on 3/22/19. 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 2
A 29-year-old female enrollee has requested reimbursement for allergen specific immunoglobulin G (IgG) (RAST/ELISA) for routine allergy testing performed on 3/22/19. 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 per the literature, immunoglobulin G (IgG) food sensitivity testing is not considered a clinically useful, relevant, or valid method for evaluating for food allergy, or for identifying food intolerance that may be contributing to gastrointestinal disease or any other condition. IgG and IgG subclass antibody tests for food allergy-related conditions do not have clinical relevance, are not validated and lack sufficient quality control. IgG signifies exposure to a food, not allergy to a food. IgG antibodies to food are commonly detectable in healthy individuals, independent of the presence or absence of food-related symptoms. Since a normal immune system should make IgG antibodies to foreign proteins, a positive IgG test to a food is a sign of a normal immune system. IgG4 against foods indicates that the organism has been repeatedly exposed to food components, recognized as foreign proteins by the immune system. Its presence should not be considered as a factor that induces hypersensitivity, but rather as an indicator for immunological tolerance, linked to the activity of regulatory T cells. At present, there is a lack of reliable and validated clinical tests for the diagnosis of food intolerance. IgG testing lacks both a sound scientific rationale and evidence of effectiveness. The lack of correlation between results and actual symptoms, and the risks resulting from unnecessary food avoidance, escalate the potential for harm from this test. Further, there is a lack of published clinical evidence to support the use of IgG tests to determine the need for vitamins or supplements or dietary modifications. In sum, allergen specific immunoglobulin G (IgG) (RAST/ELISA) for routine allergy testing performed on 3/22/19 was not likely to have been more beneficial than other methods of evaluating this patient.
| 1 |
The patient is a 57-year-old female who previously submitted a request for an
independent medical review (IMR) for reimbursement for positron emission
tomography (PET) scan with computed tomography (CT) for attenuation performed
on 3/02/20 and 9/01/20. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 57-year-old female who previously submitted a request for an
independent medical review (IMR) for reimbursement for positron emission
tomography (PET) scan with computed tomography (CT) for attenuation performed
on 3/02/20 and 9/01/20. The physician reviewer found that the letter
requesting a re-review cited the policy of the NIA, which describes
aSubsequent Treatment Strategy (Indications for an Oncological FDG PET
SCAN).a(cid:157) However, the complete quote from the NIA guidelines was not noted
in the letter of appeal. Specifically, the complete quote from the NIA
guidelines states, aRestaging or monitoring response to active treatment,
and/or a single evaluation after completion/cessation of therapy not to be
performed within four weeks of completion of therapy (ideally FDG PET is
delayed two to three months after surgical therapy, two to three months after
radiation therapy if locoregional assessment is the imaging goal), and/or
evaluation for suspicion of recurrence due to new or changing signs/symptoms.
(Asymptomatic surveillance is not approvable) (NCCN, 2018).a(cid:157) Thus, the NIA
guidelines are in agreement with the NCCN guidelines that state that
asymptomatic surveillance is not approvable. Therefore, the additional
documentation does not change the original IMR determination. The requested
PET scan with CT for attenuation performed on 9/01/20 was not medically
necessary for the evaluation of this patient.
| 1 |
The patient is a 58-year-old male with prostate cancer. He presented with an elevated prostate-specific antigen (PSA) level of 5. He had core biopsies performed where 3 of 14 cores were positive for prostate adenocarcinoma, Gleason score 3+3=6. The patient has requested reimbursement for Oncotype DX Prostate Assay performed on 9/29/17. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient. | Overturned | Experimental | Summary Reviewer 3
The patient is a 58-year-old male with prostate cancer. He presented with an elevated prostate-specific antigen (PSA) level of 5. He had core biopsies performed where 3 of 14 cores were positive for prostate adenocarcinoma, Gleason score 3+3=6. The patient has requested reimbursement for Oncotype DX Prostate Assay performed on 9/29/17. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient. Once prostate cancer is diagnosed in a pathologic specimen, risk stratification is performed by the analysis of certain features, such as the grade of tumor and PSA level. This helps guide the most appropriate therapy for patients taking into account their age and comorbidities, because many patients will not require therapy and may be followed closely instead. The important features to recognize are Gleason score and PSA, but these are imperfect. Thus, current biomarkers are inadequate for risk stratification, and better prognostic biomarkers are needed. Oncotype DX Prostate Assay is a gene expression analysis of target genes in the biopsy specimen that generates a genomic prostate score (GPS). The GPS identifies patients that had very low risk disease that could be followed rather than referred for surgery. The current prognostic features are inadequate to make firm recommendations regarding active surveillance to patients. Thus, the Oncotype DX Prostate Assay is medically appropriate in this context. All told, Oncotype DX Prostate Assay performed on 9/29/17 was likely to be superior over other available 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 68-year-old female enrollee has requested reimbursement for human epididymis protein 4 (HE4) testing performed on 9/20/18. 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 68-year-old female enrollee has requested reimbursement for human epididymis protein 4 (HE4) testing performed on 9/20/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that there is a lack of support for the services at issue in this clinical setting. In patients with endometrial cancer, human epididymis protein 4 (HE4) has been described as a potential marker for deep myometrial invasion and for advanced-stage disease. However, the sensitivity and specificity is not well-documented, and normal values are still being delineated. Routine testing is not considered a standard of care for surveillance and is unlikely to change outcomes in determining recurrence of disease. In sum, HE4 testing performed on 9/20/18 was not likely to have been of greater benefit than other methods of evaluating this patient.
| 0 |
A 57-year-old female enrollee has requested authorization and coverage for biliopancreatic bypass with duodenal switch (CPT code 43845) and one day inpatient admission. The Health Insurer has denied this request indicating that requested services are considered investigational for treatment of the enrollee, who has a history of morbid obesity and type 2 diabetes.T | Overturned | Experimental | Summary Reviewer 3
A 57-year-old female enrollee has requested authorization and coverage for biliopancreatic bypass with duodenal switch (CPT code 43845) and one day inpatient admission. The Health Insurer has denied this request indicating that requested services are considered investigational for treatment of the enrollee, who has a history of morbid obesity and type 2 diabetes.The physician reviewer found that in patients who seek surgical cure or amelioration of diabetes and obesity, several options exist. Among these options are laparoscopic sleeve gastrectomy, which this patient had undergone. The medical studies indicated that sleeve gastrectomy was first offered as the first part of a two-stage biliopancreatic diversion for patients who were super-obese, and are felt to be poor surgical candidates. It was then that it was realized that sleeve gastrectomy could stand on its own as a bariatric surgery. Nevertheless, there is a group of patients for whom sleeve gastrectomy fails to effect good glycemic control, as in this patients case. For these patients, the best remaining surgical solution is conversion of biliopancreatic bypass. Biliopancreatic bypass with duodenal switch is documented to be superior to medical management for treatment of weight loss. As such, biliopancreatic bypass with duodenal switch (CPT code 43845) and one day inpatient admission are likely to be more effective than the other available options for the treatment of this patient. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
patient is a 45-year-old male with history of major depressive disorder. The patient has requested reimbursement and prospective authorization and coverage for transcranial magnetic stimulation provided from 8/12/20 forward. The Health Insurer has denied this request and reported that the services at issue were not and are not medically necessary for the treatment of this patient.
This patient has had prior trials of two antidepressants. He has also been in weekly CBT since 2015, and this has also been ineffective. | Overturned | Medical Necessity | Summary Reviewer
This patient is a 45-year-old male with history of major depressive disorder. The patient has requested reimbursement and prospective authorization and coverage for transcranial magnetic stimulation provided from 8/12/20 forward. The Health Insurer has denied this request and reported that the services at issue were not and are not medically necessary for the treatment of this patient. The physician reviewer found that the submitted documentation supports the medical necessity of the services at issue. This patient has had prior trials of two antidepressants. He has also been in weekly CBT since 2015, and this has also been ineffective. For patients with major depression that does not respond to initial treatment with an antidepressant and who decide to switch treatment, another reasonable option is repetitive transcranial magnetic stimulation. Meta-analysis of randomized trials that compared transcranial magnetic stimulation with sham treatment indicate that transcranial magnetic stimulation can be efficacious for acute treatment-resistant depression. Repetitive transcranial magnetic stimulation is indicated for patients with unipolar depression who have failed at least one antidepressant medication. Use of repetitive transcranial magnetic stimulation for treatment-resistant depression is consistent with treatment guidelines from the American Psychiatric Association. Therefore, transcranial magnetic stimulation provided from 8/12/20 forward was and is medically necessary for the treatment of this patient. | 1 |
The patient is a 57-year-old male with a history of oligometastatic adenocarcinoma of his prostate gland. The patient has requested authorization and coverage for intensity modulated radiation therapy image-guided radiation. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 57-year-old male with a history of oligometastatic adenocarcinoma of his prostate gland. The patient has requested authorization and coverage for intensity modulated radiation therapy image-guided radiation. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. The physician reviewer found that the requested services are standard of care in this clinical setting. High-quality clinical outcomes published in the peer-reviewed medical literature have proven that aggressive consolidation of oligometastatic prostate cancer is associated with a significant improvement in chances for long-term survival. The high-quality prospective trial by Parker and colleagues supports such a benefit, as definitive radiotherapy improved failure-free survival. IMRT is widely employed nationwide for similar patients in this setting. Therefore, intensity modulated radiation therapy image-guided radiation is medically necessary for the treatment of this patient. | 1 |
A 62-year-old male enrollee has requested reimbursement for laboratory services provided on 9/06/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 3
A 62-year-old male enrollee has requested reimbursement for laboratory services provided on 9/06/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that melanoma is a cancer that is curable in its earliest stages. Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76-1.0 mm. Metastases to regional lymph nodes may be amenable to excision, but this suggests a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha. The data on the DecisionDx-Melanoma test has not made it part of routine analysis after sentinel lymph node biopsy. There has been some lack of consistency between various genes being used as biomarkers. As such, the test is novel, and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. Thus, laboratory services provided on 9/06/18 were not likely to have been more beneficial than other methods of evaluating this patient.
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A 41-year-old female enrollee has requested reimbursement for Cymetra micronized AlloDerm tissue provided on 2/13/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees left vocal fold paresis status post excision of vagal nerve schwannoma. | Overturned | Medical Necessity | Summary Reviewer
A 41-year-old female enrollee has requested reimbursement for Cymetra micronized AlloDerm tissue provided on 2/13/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees left vocal fold paresis status post excision of vagal nerve schwannoma. The physician reviewer found there are many different types of injectable material used for augmentation of a paralyzed vocal cord. Cymetra micronized AlloDerm injectable tissue is a widely utilized material for use in this clinical setting. It has low risk of infectious transmission, but is otherwise medically indicated and accepted as part of standard care in the otolaryngologic community. All told, the Cymetra micronized AlloDerm tissue provided on 2/13/15 was medically necessary for treatment of this patients left vagal nerve schwannoma with resultant left vocal cord paresis. In conclusion, 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 28-year-old female enrollee has requested reimbursement for the Anser ADA testing performed on 12/1/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition.
. In this case, the patients Crohns was responsive to Humira, but she developed a rash of uncertain origin for which the Prometheus Anser assay was ordered. | Upheld | Experimental | Summary Reviewer 2
A 28-year-old female enrollee has requested reimbursement for the Anser ADA testing performed on 12/1/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that the Anser ADA testing performed on 12/1/15 is not supported by the documentation submitted for review. In this case, the patients Crohns was responsive to Humira, but she developed a rash of uncertain origin for which the Prometheus Anser assay was ordered. It has not yet been established in the peer-reviewed literature whether the use of threshold levels aid in the discrimination of treatment response, nor has the optimal timing of when to measure antibody levels been established. Generally, diminished or suboptimal response to adalimumab can be managed by shortening the interval between doses, increasing the dose, switching to a different anti-TNF agent or switching to a non-anti-tumor necrosis factor agent based on clinical observation in lieu of Anser testing. For the reasons provided, the Anser ADA testing performed on 12/1/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The parent of a 16-year-old male enrollee has requested reimbursement for the residential treatment services provided from 4/28/14 through 6/21/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees anxiety and attention deficit hyperactivity disorder (ADHD). | Upheld | Medical Necessity | Summary Reviewer
The parent of a 16-year-old male enrollee has requested reimbursement for the residential treatment services provided from 4/28/14 through 6/21/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees anxiety and attention deficit hyperactivity disorder (ADHD). The physician reviewer found that the records provided for review do not support the medical necessity of the residential treatment services provided from 4/28/14 through 6/21/14. The patient did not demonstrate behaviors concerning for him to place himself or other at imminent risk of harm. Psychiatric issues prompting his admission including depression and irritability could have been safely and adequately treated at a less intensive setting. There were no acute impairments, behaviors, or issues with cognition that interfered with the patients ability to perform activities of daily living. Further, psychosocial and environmental problems were not likely to undermine treatment at a less intensive level of care, such as outpatient care. Throughout the admission, he was motivated by earning the reward of a home visit and there was no evidence he required residential care for treatment of his symptoms. All told, the documentation does not indicate the residential treatment services were 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 34-year-old female enrollee has requested reimbursement for the gene test provided on 3/17/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees risk for heart disease. The physician
that the records provided for review document that this patient underwent advanced lipoprotein testing. | Upheld | Experimental | Summary Reviewer 2
A 34-year-old female enrollee has requested reimbursement for the gene test provided on 3/17/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees risk for heart disease. The physician reviewer found that the records provided for review document that this patient underwent advanced lipoprotein testing. In this circumstance, guidelines for the management of cardiac risk and dyslipidemia have been established, are periodically updated by expert committees, and are endorsed by several national organizations. These guidelines currently do not recommend routine performance of specialized tests in the context of assessing coronary risk including Lp-PLA2, sub-classifications of low density lipoprotein (LDL), high density lipoprotein (HDL) subclasses, lipoprotein (a), C-reactive protein (CRP), high sensitivity CRP, insulin, fibrinogen, genetic testing and homocysteine (Greenland, et al; Stone, et al). Treatment change or addition based on the results of screening with these specialized tests has not been shown to improve cardiac outcome incremental to that achievable by treatment based on standard risk factor profiling and basic lipid analysis (Lonn; Toole, et al). All told, the gene test provided on 3/17/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The patient is a 20-year-old female with generalized anxiety disorder, sedative/hypnotic/anxiolytic dependence, alcohol dependence, cannabis dependence, borderline personality disorder and major depressive disorder. She has requested reimbursement for partial hospitalization program services provided from 12/08/20 through 12/10/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient.
patient was admitted to residential treatment following a suicide attempt and continued to have passive suicidal ideation through much of her treatment. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 20-year-old female with generalized anxiety disorder, sedative/hypnotic/anxiolytic dependence, alcohol dependence, cannabis dependence, borderline personality disorder and major depressive disorder. She has requested reimbursement for partial hospitalization program services provided from 12/08/20 through 12/10/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. The physician reviewer found that The American Association of Community Psychiatrists Level of Care Utilization System (LOCUS) provides a reliable framework for determining the appropriate level of care for adults needing mental health treatment. Using LOCUS, providers score patients on a scale of 1-5 using a six-pronged Dimensional Rating System. The six dimensions include: (1) risk of harm; (2) functional status; (3) medical, addictive and psychiatric comorbidity; (4) recovery environment (a. stressors and b. supports); (5) treatment and recovery history; and (6) engagement. The composite score is then used to determine the level of care needed. Applying the LOCUS framework, the patient met the criteria for partial hospitalization program services. In terms of risk of harm, the records support a score of 4. This dimension assesses potential for harm to self or others. This patient was admitted to residential treatment following a suicide attempt and continued to have passive suicidal ideation through much of her treatment. Therefore, there was a serious risk of harm given her past history of carrying out suicidal behavior. With regard to function, the records support a score of 3. This dimension assesses the degree to which a person is able to fulfill social responsibilities and maintain physical functioning and capacity for self-care. The patient was expelled from college for substance use on campus prior to admission to residential treatment. She continued to have conflictual relationships with those around her and was quite isolated and withdrawn. In terms of comorbidity, the records support a score of 3. This dimension assesses potential complications in the course of treatment due to acuity or disability related to co-occurring medical illness, substance use disorder, or psychiatric disorder. The patient has had recent substance use with clearly detrimental effects on her presenting disorder. With regard to level of stress of the recovery environment, the records support a score of 3. This dimension assesses the stressors in the environment, social circumstances, and interpersonal relationships. The patient has had a recent romantic relationship break-up and has been expelled from college. She has had significant discord in her family relationships. In terms of level of support of the recovery environment, the records support a score of 3. This dimension assesses the presence of family and social support to augment the recovery environment. Although the patient cites a large friend group, she does not actually name these friends as supports. Her only real support is her mother, with whom she has a conflictual relationship. With regard to treatment and recovery history, the records support a score of 3. This dimension assesses how past experiences with treatment and recovery might indicate how the patient might respond in the future. In this case, previous treatment had not achieved complete remission of symptoms or optimal control of symptoms despite having been hospitalized psychiatrically in 2020 and recent completion of residential treatment. In terms of engagement, the records support a score of 3. This dimension assesses a patientas understanding of his or her illness and treatment, and ability and willingness to engage in the treatment process. This patient has had variability and hesitation in her engagement in treatment and has some difficulty accepting responsibility for her recovery. Thus, the patient has a composite score of 22, which is consistent with medically monitored community-based services or partial hospitalization program level of care. Of note, the patientas score of 4 in terms of risk of harm supports residential treatment. Thus, there is sufficient support for partial hospitalization program level of care in this setting. Therefore, partial hospitalization program services provided from 12/08/20 through 12/10/20 were medically necessary for the treatment of this patient.
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The parent of a 13-year-old male enrollee has requested authorization and coverage for Humatrope 24 mg cartridge. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition.
This patient had a low annual growth velocity which indicated abnormal growth. His estimated adult height gradually declined to 66 inches, which indicates poor growth. His estimated adult height is below his genetic potential of 71.6 inches. Per the records, he failed growth hormone stimulation testing with a peak less than 10ng/mL, which indicates | Overturned | Medical Necessity | Summary Reviewer
The parent of a 13-year-old male enrollee has requested authorization and coverage for Humatrope 24 mg cartridge. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the requested medication in this clinical setting. This patient had a low annual growth velocity which indicated abnormal growth. His estimated adult height gradually declined to 66 inches, which indicates poor growth. His estimated adult height is below his genetic potential of 71.6 inches. Per the records, he failed growth hormone stimulation testing with a peak less than 10ng/mL, which indicates growth hormone deficiency in the setting of poor growth. Therefore, Humatrope 24 mg cartridge is medically necessary for the treatment of this patient. | 1 |
The patient is a 63-year-old male who has been diagnosed with a squamous cell carcinoma of the thymus. In May 2015, he had resection of gross tumor, but was found to have very locally extensive cancer. The surgery was followed by four cycles of chemotherapy along with radiation therapy. This therapy ended in November 2015. He was noted to have progression of disease approximately in October 2016 and was retreated with chemotherapy at that time. As of September 2017, he was relatively stable. A tissue sample was sent for FoundationOne assay. The patient has requested reimbursement for the FoundationOne testing performed on 12/28/16. Per the Health Insurer, the services at issue were investigational for evaluation of this patients medical condition. | Overturned | Experimental | Summary Reviewer 1
The patient is a 63-year-old male who has been diagnosed with a squamous cell carcinoma of the thymus. In May 2015, he had resection of gross tumor, but was found to have very locally extensive cancer. The surgery was followed by four cycles of chemotherapy along with radiation therapy. This therapy ended in November 2015. He was noted to have progression of disease approximately in October 2016 and was retreated with chemotherapy at that time. As of September 2017, he was relatively stable. A tissue sample was sent for FoundationOne assay. The patient has requested reimbursement for the FoundationOne testing performed on 12/28/16. Per the Health Insurer, the services at issue were investigational for evaluation of this patients medical condition. There is a lack of support for the services at issue in this clinical setting. FoundationOne is a molecular assay that explores the mutations of an individuals cancer cells. The hope is that the assay will identify a specific mutation or target, which could inform the clinician as to which chemotherapeutic drug would be useful. However, there is a lack of convincing evidence that the assay adds to the decision making ability of the clinician, nor yields a result that is reliably clinically beneficial. There are various non-randomized studies exploring the value of molecular profiling but these studies are not definitive or compelling as to the efficacy of the assay. A randomized study by Le Tourneau and colleagues did not demonstrate significant clinical benefit from choosing therapy based on molecular targets. Finding a mutation does not guarantee that a treatment directed at that mutation will produce a clinically meaningful response. All told, the FoundationOne testing performed on 12/28/16 was not likely to have been more efficacious than other methods of evaluating this patients medical condition. Therefore, for the reasons stated above, the services at issue were not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial sho
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A 25-year-old male enrollee has requested reimbursement for corneal crosslinking provided on 8/06/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 1
A 25-year-old male enrollee has requested reimbursement for corneal crosslinking provided on 8/06/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the services at issue in this clinical setting. The records document keratoconus and vision loss. Corneal collagen cross-linking is a safe and effective procedure for stabilizing corneal ectasia and potentially delaying or preventing the need for full-thickness corneal transplant. Furthermore, corneal collagen cross-linking for corneal ectasias fulfills an unmet need. There is a lack of other treatment options available to slow or halt disease progression. Therefore, corneal cross-linking provided on 8/06/18 was likely to have been more beneficial than other available treatment options.
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The patient is a 45-year-old male diagnosed with amyotrophic lateral sclerosis (ALS) in 2013. The patient initially presented with right hand cramps and weakness. An electromyogram (EMG) showed extensive lower motor neuron changes. The patients provider recommends treatment with Radicava to slow decline of physical function, decrease caregiver burden and to improve quality of life. The patient has requested authorization and coverage for edaravone (Radicava). The Health Insurer has denied this request as investigational. | Overturned | Experimental | Summary Reviewer 3
The patient is a 45-year-old male diagnosed with amyotrophic lateral sclerosis (ALS) in 2013. The patient initially presented with right hand cramps and weakness. An electromyogram (EMG) showed extensive lower motor neuron changes. The patients provider recommends treatment with Radicava to slow decline of physical function, decrease caregiver burden and to improve quality of life. The patient has requested authorization and coverage for edaravone (Radicava). The Health Insurer has denied this request as investigational. Radicava is approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with ALS. Radicava has shown efficacy in a small subset of people with ALS who met criteria identified in post-hoc analysis of a previous phase III study, showing a significantly smaller decline of Revised ALS Functional Rating Scale (ALSFRS-R) score compared with placebo (Abe, et al). Based on the above, this patient is likely to benefit from the use of Radicava. All told, the request for Radicava is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested medication is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 38-year-old female enrollee has requested reimbursement for Guardant360 CDx panel
performed on 4/01/21. The Health Insurer has denied this request and reported that the services
at issue were investigational for the evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 3
A 38-year-old female enrollee has requested reimbursement for Guardant360 CDx panel
performed on 4/01/21. 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 Guardant Assay is an assay done on the patients blood, looking for DNA
presumably of the cancer cells origin. It is generally approved in situations where tissue biopsy
is approved, wherein tissue biopsy is not safe or feasible. Overall, the percentage of patients who
benefit using such assays to choose a therapeutic agent appears to be small. The overall use of
this assay to pick a treatment is not likely to be beneficial. There is at least one mutation (PIK3CA)
that does have therapeutic indication if the patient has an estrogen receptor positive cancer that
is no longer responding to hormonal therapy with CDK4/6 inhibition. However, there is a lack of
support for the whole general panel. Therefore, Guardant360 CDx panel performed on 4/01/21
was not likely to have been more beneficial for evaluation of the patients medical condition than
any available standard therapy.
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The patient is a 63-year-old female with a history of chronic bilateral knee pain due to
osteoarthritis. The patient has requested authorization and coverage for Synvisc-One injections.
The Health Insurer has denied this request and reported that the requested services are not
medically necessary for the treatment of this patient. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 63-year-old female with a history of chronic bilateral knee pain due to
osteoarthritis. The patient has requested authorization and coverage for Synvisc-One injections.
The Health Insurer has denied this request and reported that the requested services are not
medically necessary for the treatment of this patient. This denial is the subject of this appeal and
determination. The physician reviewer found that an exhaustive review of the current medical
literature pertaining to viscosupplementation reveals mixed results. Evidence from eight
systematic reviews and six randomized controlled trials indicates that although
viscosupplementation may relieve knee pain in some individuals with osteoarthritis, it is not
known as to which individuals will benefit. Different studies have tried mixing hyaluronic acid
with corticosteroids, platelet-rich plasma, and other agents to make it more effective. The
guidelines from organizations such as the American Academy of Orthopedic Surgeons indicate
that the evidence is not conclusive. In light of the foregoing, viscosupplementation can only be
recommended in individuals with a history of lasting benefit from prior injections and in carefully
selected cases where everything else has been tried and the options are limited. In this case, the
patient benefitted from viscosupplementation in the past. The injections lasted six months at a time
and were provided on multiple occasions in 2018 and 2019. Corticosteroid injections were not
successful. Furthermore, in light of the mild degree of osteoarthritis in both knees, the patient is
an ideal candidate for viscosupplementation. Therefore, the requested Synvisc-One injections are
medically necessary for the treatment of this patient.
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A 26-year-old female enrollee has requested authorization and coverage for Xeljanz 5 mg The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees alopecia areata.
Per the records, Xeljanz resulted in excellent regrowth of her hair. | Overturned | Experimental | Summary Reviewer 3
A 26-year-old female enrollee has requested authorization and coverage for Xeljanz 5 mg The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees alopecia areata. The physician reviewer found that there is sufficient support for the requested medication in this patients case. Per the records, Xeljanz resulted in excellent regrowth of her hair. The use of Xeljanz for extensive alopecia areata and alopecia totalis has been very promising. There are currently case series in the literature and clinical trials evaluating the efficacy of this treatment on alopecia areata. There is a lack of U.S. Food and Drug Administration (FDA) approved medications for the treatment of this condition, and the use of tofacitinib has been shown to be effective in this setting. There are no other more effective therapies that can be offered as an alternative. Thus, Xeljanz 5 mg is likely to be superior over other available treatment options. Based upon the information set forth above, the requested medication is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 63-year-old female enrollee has requested reimbursement of liquid CDx laboratory testing by
FoundationOne on 4/29/22. The Health Insurer has denied this request and reported that the service
at issue was investigational for the evaluation of the enrollees lung cancer.
In this case, the patient developed local recurrence along with metastatic disease to the brain. Based
on the patients KRAS G12C mutation identified by the service at issue, a targeted treatment,
specifically sotorasib, was identified. In a study including 928 patients with stage IV NSCLC, of
which 295 patients underwent NGS, | Overturned | Experimental | Summary Reviewer 2
A 63-year-old female enrollee has requested reimbursement of liquid CDx laboratory testing by
FoundationOne on 4/29/22. The Health Insurer has denied this request and reported that the service
at issue was investigational for the evaluation of the enrollees lung cancer. At issue is whether
CDx laboratory testing by FoundationOne on 4/29/22 was likely to have been more beneficial for
evaluation of the enrollee's condition than any available standard therapy. The physician reviewer
found that in this clinical setting, the NCCN guidelines for the treatment of NSCLC note that next
generation sequencing (NGS) is appropriate to detect actionable mutations for targeted treatment.
In this case, the patient developed local recurrence along with metastatic disease to the brain. Based
on the patients KRAS G12C mutation identified by the service at issue, a targeted treatment,
specifically sotorasib, was identified. In a study including 928 patients with stage IV NSCLC, of
which 295 patients underwent NGS, Al-Ahmadi and colleagues report, Patients undergoing NGS
testing had significantly longer survival of 25.3 months versus those who did not undergo
sequencing with a median survival of 14.6 months irrespective if they received targeted therapy or
not. that patients In this clinical setting, the service at issue was likely to have been more
beneficial for treatment of this patient than not utilizing NGS. In this case, while notes dated
7/27/22 reported that the patient underwent EBUS with tissue biopsy, the records do not document an NGS result from the tissue biopsy. Therefore, CDx laboratory testing by FoundationOne on
4/29/22 was likely to have been more beneficial for evaluation of the patients condition than any
available standard therapy.
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A 49-year-old female enrollee has requested authorization and coverage for breast susceptibility gene (BRCA) testing. The Health Insurer has denied this request indicating that the requested services are not medically necessary for evaluation of the enrollees medical condition. | Upheld | Medical Necessity | Summary Reviewer
A 49-year-old female enrollee has requested authorization and coverage for breast susceptibility gene (BRCA) testing. The Health Insurer has denied this request indicating that the requested services are not medically necessary for evaluation of the enrollees medical condition. The physician reviewer found BRCA mutations are associated with a high incidence of both breast and ovarian cancer. Being BRCA positive has several implications for measures to be considered by the patient. With regards to breast cancer, she can consider more intense screening with magnetic resonance imaging or even bilateral mastectomies. With regards to ovarian cancer, it is recommended that such women have bilateral salpingo-oophorectomy at the appropriate age. Thus BRCA is a genetic test of great potential importance and value. However, there is a lack of support for the requested services in this patients case. U.S. Preventative Services Task Force indicates that testing is recommended for women who have a family history including three or more first-degree or second-degree relatives with breast cancer, regardless of age of their diagnosis. Additionally, there is support for BRCA testing for patients who have a close relative diagnosed with breast cancer under the age of 50. None of these criteria appear to apply to this patient. All told, the requested breast susceptibility gene (BRCA) testing is not medically indicated for the evaluation of this patient. Therefore, the requested services are not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
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The patient is a 58-year-old female with osteoporosis. The patient has requested reimbursement and prospective authorization and coverage for Prolia injections provided from 11/19/20 forward. The Health Insurer has denied this request and reported that the medication at issue was not and is not medically necessary for the treatment of this patient. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 58-year-old female with osteoporosis. The patient has requested reimbursement and prospective authorization and coverage for Prolia injections provided from 11/19/20 forward. The Health Insurer has denied this request and reported that the medication at issue was not and is not medically necessary for the treatment of this patient. The physician reviewer found that Osteoporosis is an increasingly widespread condition. Fractures are the most dangerous aspect of osteoporosis and can lead to acute and chronic pain. A newer medication, denosumab (Prolia) is a fully human monoclonal antibody that has been approved for the treatment of osteoporosis, treatment-induced bone loss, bone metastases, multiple myeloma, and giant cell tumor of bone. Prolia is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy. In this case, the patient has an increased risk of fracture, with a lowest T-score of -3.2 on 10/14/20. There is sufficient support for the medication at issue in this clinical setting. Therefore, Prolia injections provided from 11/19/20 forward were and are medically necessary for the treatment of this patient. | 1 |
The patient is a 53-year-old female who has been diagnosed with a melanoma on her thigh measuring 0.4 mm Breslow depth. Her provider sent her tissue for molecular genetic testing to help determine the risk of spread of the tumor. The patient has requested reimbursement for the genetic testing performed on 9/15/17. The Health Insurer denied this request for reimbursement and noted that the services at issue were considered investigational for the evaluation of this patients medical condition.
The patients provider recommended her tissue be sent for a test called DecisionD | Upheld | Experimental | Summary Reviewer 2
The patient is a 53-year-old female who has been diagnosed with a melanoma on her thigh measuring 0.4 mm Breslow depth. Her provider sent her tissue for molecular genetic testing to help determine the risk of spread of the tumor. The patient has requested reimbursement for the genetic testing performed on 9/15/17. The Health Insurer denied this request for reimbursement and noted that the services at issue were considered investigational for the evaluation of this patients medical condition. The DecisionDx-Melanoma assay tests the tissue genetics of the melanoma and can stratify whether a melanoma is high risk for metastasis or not. The patients provider recommended her tissue be sent for a test called DecisionDX where the genes are examined for certain markers and then the lesion can be further stratified to tell if it is high risk for metastasis. This test has shown some accuracy determining risk of metastasis in thin thickness melanomas like this patients; however, decision-making based on the results of the test is indeterminate at this time. The treatment of this patient would not change based on the results of the examination. Moreover, this test is not considered a routine standard of care and is not currently recommended by the National Comprehensive Cancer Network (NCCN) guidelines. There is not enough published data to support its routine use. Accordingly, the genetic testing performed on 9/15/17 was not likely to have been more effective than the available standard options for evaluating this patients medical condition. Therefore, for the reasons stated above, the services at issue were not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 61-year-old female enrollee has requested reimbursement for Botox injections provided on 12/13/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees low back pain and spasms. | Upheld | Experimental | Summary Reviewer 3
A 61-year-old female enrollee has requested reimbursement for Botox injections provided on 12/13/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees low back pain and spasms. The physician reviewer found that there is a lack of support for the services at issue in this patients case. Current evidence-based literature indicates that there is a lack of high-quality studies evaluating Botox injections for patients with low back pain and myofascial pain syndrome. There is a lack of clear evidence that the patient had been refractory to other treatments, as there is documented benefit with the custom heel lift and trigger point injections. Thus, Botox injections provided on 12/13/17 was not likely to have been more effective than other available treatment options. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 58-year-old male enrollee has requested authorization and coverage for Vesicare. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees nocturia.
In this case, the patient presents with urinary obstruction as well as overactive bladder. | Overturned | Medical Necessity | Summary Reviewer
A 58-year-old male enrollee has requested authorization and coverage for Vesicare. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees nocturia. The physician reviewer found that based on the medical literature and the clinical records submitted for review, the request for Vesicare is medically necessary for treatment of the patients medical condition. In this case, the patient presents with urinary obstruction as well as overactive bladder. Treatment with Vesicare is medically indicated to relieve the patients overactive bladder symptoms. In addition, the patient reports significant improvement with Vesicare. For the reasons provided, the request for Vesicare has been established as medically necessary for treatment of the patients medical condition. Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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A 66-year-old male enrollee has requested reimbursement for gene expression profiling of melanomas performed on 3/29/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. | Upheld | Experimental | Summary Reviewer 2
A 66-year-old male enrollee has requested reimbursement for gene expression profiling of melanomas performed on 3/29/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that this patient had an early stage melanoma. The National Comprehensive Cancer Network guidelines state while there is interest in newer prognostic molecular techniques, such as gene expression profiling, to differentiate melanomas at low versus high risk for metastasis, routine prognostic genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study. The results of the services at issue were not likely to have altered treatment and surveillance recommendations. In sum, gene expression profiling of melanomas performed on 3/29/18 was not likely to have been more effective than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 49-year-old female enrollee has requested reimbursement for endometrial ablation performed on 9/23/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrolleeas medical condition. | Upheld | Experimental | Summary Reviewer 3
A 49-year-old female enrollee has requested reimbursement for endometrial ablation performed on 9/23/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that this patient had a history of menorrhagia. One of the first steps in this setting is to perform an endometrial biopsy to rule out a malignancy or premalignant lesion and to determine what therapy is more appropriate. The submitted records do not document that an endometrial biopsy was performed. In women aged 40 years to menopause, abnormal uterine bleeding may be due to anovulatory bleeding, which represents normal physiology in response to declining ovarian function. It also may be due to endometrial hyperplasia or carcinoma, endometrial atrophy, and leiomyomas. Prior to performing an endometrial ablation, the structure and histology of the endometrial cavity should be thoroughly evaluated, both to assess for malignancy or endometrial hyperplasia and to ensure that the length and configuration is suitable for endometrial ablation. These parameters will vary depending on the technique or system used. Endometrial sampling, typically with an outpatient technique, can be used to evaluate all women for hyperplasia or malignancy, and results should be reviewed before ablation is scheduled. In this case, the records do not adequately document the need for an ablation. In addition, no hematocrit was submitted to assess the degree of bleeding. Many conservative options can be used in this setting prior to proceeding with an ablation. Nonsteroidal anti-inflammatory drugs (NSAIDs) can reduce the amount of bleeding. Progestins and oral contraceptive pills are considered first-line treatment for abnormal, irregular or heavy bleeding. Ideally, the patient could use hormonal treatment for at least three months. If there is a failure to control the bleeding, then another option could be used. The provider stated that the enrollee did not tolerate oral contraceptives and did not respond to 10 days of a progestin. It may take more than 10 days to respond to a progestin, and there is no information when the oral contraceptives were used and what was the tolerance issue. The levonorgestrel-releasing intrauterine system has been shown to significantly reduce bleeding and cramping and may be used in the treatment for women with heavy abnormal bleeding. Tranexamic acid (Lysteda) is an antifibrinolytic taken during menstruation. It has been shown to be an effective treatment to decrease abnormal heavy uterine bleeding and improve quality of life. The patient has not tried this treatment. Therefore, there were multiple safe conservative treatment options available prior to proceeding with an ablation. Therefore, endometrial ablation performed on 9/23/20 was not likely to have been more beneficial than other available standard therapy.
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A 28-year-old female insured has requested authorization and coverage for intravenous (IV)
Gammagard. The Health Insurer has denied this request indicating that the requested treatment is
considered investigational for the treatment of the insured's refractory relapsing polychondritis. | Overturned | Experimental | Summary Reviewer 1
A 28-year-old female insured has requested authorization and coverage for intravenous (IV)
Gammagard. The Health Insurer has denied this request indicating that the requested treatment is
considered investigational for the treatment of the insured's refractory relapsing polychondritis.
The physician reviewer found that relapsing polychondritis is a systemic immune-mediated
disorder that causes inflammation and damage to cartilage-containing structures within the human
body (Lekpa and Chevalier). Steroid-dependent, refractory and/or life-threatening relapsing
polychondritis is an indication for immunosuppressive or immunomodulatory drug therapy in
patients with this disorder. The current medical literature suggests that treatment options for
patients with relapsing polychondritis include therapies such as colchicine, dapsone, methotrexate,
cyclophosphamide, cyclosporine, azathioprine, mycophenolate mofetil, IVIG, and leflunomide
(Petitdemange, et al.). Biologic therapies include treatments such as adalimumab, infliximab,
tocilizumab, rituximab, and abatacept. There is a lack of data supporting the superiority of one
particular therapy in the treatment of patients with relapsing polychondritis. In this case, the
records provided for review reflect that the patient has already attempted and failed treatment with
several standard therapies for relapsing polychondritis including high-dose steroids, dapsone,
methotrexate, azathioprine, adalimumab, infliximab, abatacept, and cyclosporin. However, the
records indicate that the patient has responded positively to IVIG. The current medical literature
also supports a remission of refractory relapsing polychondritis with the use of IVIG. For these
reasons, the requested IV Gammagard is likely to be more beneficial for the treatment of the
patients condition than any available standard therapy.
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The parent of a four-year-old male enrollee has requested reimbursement for the polymerase chain reaction (PCR) testing and homocysteine testing performed on 6/4/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees risk for methylenetetrahydrofolate (MTHFR), Factor V Leiden, and homocysteine mutations. | Upheld | Experimental | Summary Reviewer 2
The parent of a four-year-old male enrollee has requested reimbursement for the polymerase chain reaction (PCR) testing and homocysteine testing performed on 6/4/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees risk for methylenetetrahydrofolate (MTHFR), Factor V Leiden, and homocysteine mutations. The physician reviewer found that the American College of Medical Genetics (ACMG) recommends against testing for MTHFR polymorphisms in any patients, including patients with relatives with known MTHFR polymorphisms. There is no risk associated with the A1298C polymorphism in the heterozygous or homozygous state. Further, it could have been predicted that this patient would have at least one copy of A1298C, as his mother is homozygous. The ACMG guideline indicates that testing of homocysteine is reasonable only in patients with two copies of the C677T polymorphisms, though this is not possible for this patient based on his mothers testing. The ACMG additionally has prepared guidelines on Factor V Leiden testing, which do not suggest testing for this patient. Accordingly, the PCR testing and homocysteine testing performed on 6/4/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 60-year-old female enrollee has requested reimbursement for laboratory services provided on 8/15/19. The Health Insurer indicates that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
this patient has advanced ovarian cancer. She has been appropriately treated with debulking surgery and will likely receive multi-agent chemotherapy that includes cisplatin. | Overturned | Experimental | Summary Reviewer 3
A 60-year-old female enrollee has requested reimbursement for laboratory services provided on 8/15/19. The Health Insurer indicates that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that this patient has advanced ovarian cancer. She has been appropriately treated with debulking surgery and will likely receive multi-agent chemotherapy that includes cisplatin. Thereafter, she will need close follow-up to identify recurrence. According to the NCCN guidelines, it will be important to know the presence of germline or somatic mutations in BRCA1 and/or BRCA2. She may be offered maintenance therapy based upon mutation status. She may also be eligible for clinical trial based on her mutational status. Therefore, laboratory services provided on 8/15/19 were likely to have been more beneficial than other available standard therapy.
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A 67-year-old female enrollee has requested reimbursement for the intraoperative radiation therapy performed on 7/19/16. The Health Plan has denied this request indicating that the service at issue is considered investigational for treatment of the enrollee breast cancer. | Upheld | Experimental | Summary Reviewer 2
A 67-year-old female enrollee has requested reimbursement for the intraoperative radiation therapy performed on 7/19/16. The Health Plan has denied this request indicating that the service at issue is considered investigational for treatment of the enrollee breast cancer. The physician reviewer found that the National Comprehensive Cancer Network (NCCN) guidelines endorse the use of intraoperative radiation therapy in the treatment of breast cancer. The patient meets all of the suitable criteria for the use of intraoperative radiation in patients with DCIS. Furthermore, intraoperative radiation would decrease toxicities from the patient undergoing radiation a second time to an adjacent field. Therefore, the intraoperative radiation therapy performed on 7/19/16 has been established as 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 service at issue was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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The parent of an eight-year-old male enrollee has requested authorization and coverage for Exondys 51. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees Duchenne muscular dystrophy.
restored dystrophin in the 30 and 50 mg/kg/week cohorts, and | Overturned | Experimental | Summary Reviewer 3
The parent of an eight-year-old male enrollee has requested authorization and coverage for Exondys 51. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees Duchenne muscular dystrophy. The physician reviewer found that there is sufficient support for the requested medication in this patients case. The U.S. Food and Drug Administration (FDA) had approved this medication in this setting. Mendell and colleagues reported that eteplirsen restored dystrophin in the 30 and 50 mg/kg/week cohorts, and in subsequently treated, placebo-controlled subjects. No severe adverse events were encountered. This crossover study showed that those patients who received placebo and later received Exondys 51 also showed improvement, proving the medication is beneficial. Thus, Exondys 51 is likely to be more effective than other treatment alternatives. Based upon the information set forth above, the requested medication is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 44-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 services are investigational for the treatment of the enrolleeas medical condition.
with chronic low back pain that had been present for at least six months, with
vertebral endplate changes. The patients were divided into two groups; half received the Intracept and the other half received standard care.
In this case, the patient has chronic low back pain with Modic Type 1 vertebral endplate changes at L4-5 and L5-S1. The provider has tried other options, with | Overturned | Experimental | Summary Reviewer 1
A 44-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 services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that there is sufficient support for the requested services in this clinical setting. Khalil and colleagues performed a randomized controlled trial to compare the effectiveness of intraosseous radiofrequency ablation of the basivertebral nerve to standard care for the treatment of chronic low back pain. The authors noted maintenance of clinical improvement at two years following radiofrequency ablation of the basivertebral nerve. This trial included 140 patients with chronic low back pain that had been present for at least six months, with Modic Type 1 or 2 vertebral endplate changes. The patients were divided into two groups; half received the Intracept and the other half received standard care. The results showed clear superiority of radiofrequency ablation of the basivertebral nerves compared to standard care. In this case, the patient has chronic low back pain with Modic Type 1 vertebral endplate changes at L4-5 and L5-S1. The provider has tried other options, with documented failure. The requested Intracept procedure is known to have a high rate of success. Therefore, the requested Intracept procedure is likely to be more beneficial than any available standard therapy.
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A 43-year-old female enrollee has requested authorization and coverage for immune globulin injection 500 mg (Gamunex-C). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 1
A 43-year-old female enrollee has requested authorization and coverage for immune globulin injection 500 mg (Gamunex-C). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that there is a lack of support for the requested services in this clinical setting. The medical evidence does not support the use of intravenous, intramuscular, or subcutaneous immune globulin as a treatment to prevent recurrent spontaneous abortion in pregnant women. The American College of Obstetricians and Gynecologists does not support the requested services for the treatment of this patient. The use of intravenous immune globulin for pregnancy loss prevention has not been demonstrated by large scale, prospective clinical trials to have superior outcomes compared to existing therapies. Therefore, immune globulin injection (Gamunex-C), 500 mg is not likely to be of greater benefit than other treatment options.
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A 59-year-old male enrollee has requested reimbursement for positron emission tomography/computed tomography (PET/CT) scan and magnetic resonance imaging (MRI) of the pelvis performed on 6/03/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for the evaluation of the enrollees medical condition.
this patient had appropriate but incomplete surgical treatment for his prostate cancer. Per the medical records, C-11 choline PET scan and MRI of the pelvis including a transrectal coil discovered the residual tumor, allowing for appropriate treatment. | Overturned | Medical Necessity | Summary Reviewer
A 59-year-old male enrollee has requested reimbursement for positron emission tomography/computed tomography (PET/CT) scan and magnetic resonance imaging (MRI) of the pelvis performed on 6/03/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found this patient had appropriate but incomplete surgical treatment for his prostate cancer. Per the medical records, C-11 choline PET scan and MRI of the pelvis including a transrectal coil discovered the residual tumor, allowing for appropriate treatment. There is sufficient support for C-11 choline PET scans to search for biochemical cases of recurrence when conventional imaging has proven to be negative. Additionally, the use of MRI of the pelvis when prostate recurrence is suspected is commonplace and indicated particularly with endorectal coil in order to visualize the prostatic bed and adjacent lymph nodes. Also, this exam can be compared with the results of the C-11 choline PET scan. The combination of the two offers the best detail of the prostatic bed and surrounding lymph nodes, which is crucial in a patient with a history of biochemical prostate cancer recurrence without obvious cause on conventional imaging. Since conventional imaging has been suboptimal for this patient in the past, the PET/CT scan and MRI of the pelvis performed on 6/03/15 were medically indicated for the evaluation of this patient. Therefore, the services at issue were medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be overturned.
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A 57-year-old male has requested authorization and coverage for cervical artificial disc replacement. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.
. This patient has symptoms noted since May 2012 which suggest multilevel nerve root changes which
addressed through a C3-4 discectomy and artificial disc replacement. | Upheld | Experimental | Summary Reviewer 3
A 57-year-old male has requested authorization and coverage for cervical artificial disc replacement. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The physician reviewer found that there is a lack of support for the requested services in this clinical setting. This patient has symptoms noted since May 2012 which suggest multilevel nerve root changes which would not necessarily be addressed through a C3-4 discectomy and artificial disc replacement. Complications specific to total disc replacement include implant failure, wear, bone implant failures, iatrogenic deformity, segmental kyphosis, failed kinematics, neurological injury and infection. It is known that the metal to methyl methacrylate bearing surface will be exposed to the wear mechanisms of abrasion, adhesion, fatigue and third body wear. A continuing particulate load of these particles will occur. It is known that there is a universal giant cell reaction and chronic inflammation in response to wear debris. 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, and there is evidence that there is a gradual loss of motion by reason of a number of factors. One of the most important of these factors is myositis ossificans, fibrous tissue and bone or an inflammatory response to wear and to the trauma of surgery, which involves the formation of both. Thus, the requested cervical artificial disc replacement is not likely to be more efficacious than other treatment options. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 30-year-old female enrollee has requested reimbursement for emergency department services received on 10/30/17. The Health Insurer has denied this request on the basis that the services were not emergent.
reveals the patient complained of a cough that had been present for one week. She denied wheezing, chest pain, fever, or leg swelling. There is no notation made that the patient was feeling short of breath. The patient was described as "in no distress." Her vital signs were normal. Mild wheezing with good air movement was noted. All testing that was performed was normal. The patient received two inhaled beta agonist treatments and oral medication. She declined any intravenous medications. This patient's symptoms were | Upheld | Medical Necessity | Summary Reviewer
A 30-year-old female enrollee has requested reimbursement for emergency department services received on 10/30/17. The Health Insurer has denied this request on the basis that the services were not emergent. The physician reviewer found that review of the submitted documentation reveals the patient complained of a cough that had been present for one week. She denied wheezing, chest pain, fever, or leg swelling. There is no notation made that the patient was feeling short of breath. The patient was described as "in no distress." Her vital signs were normal. Mild wheezing with good air movement was noted. All testing that was performed was normal. The patient received two inhaled beta agonist treatments and oral medication. She declined any intravenous medications. This patient's symptoms were not acute in onset nor were they severe. All told, the patients symptoms on 10/301/7 did not meet prudent layperson criteria for emergency care. A prudent layperson in the patients circumstances would not reasonably expect the absence of emergency care to jeopardize his or her health. Therefore, the Health Insurers denial should be upheld. | 1 |
A 50-year-old female enrollee has requested reimbursement for anesthesia services provided on 9/29/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees risk for colon cancer. | Upheld | Medical Necessity | Summary Reviewer
A 50-year-old female enrollee has requested reimbursement for anesthesia services provided on 9/29/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees risk for colon cancer. The physician reviewer found the patient sites a rationale of malignant hyperthermia as a reason for the monitored anesthesia care used for the colonoscopy and endoscopy. However, the routine sedation for these procedures is not a contraindication for a history of malignant hyperthermia. General anesthesia is not needed for colonoscopy and therefore, this procedure is not at risk of provoking a malignant hyperthermia crisis. The patient is otherwise healthy and does not meet criteria for the use of monitored anesthesia care for colonoscopy or endoscopy. All told, the monitored anesthesia care services provided on 9/29/14 were not medically necessary for evaluation of this patients medical condition. Based on the foregoing discussion, the services at issue were not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
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A 55-year-old female enrollee has requested reimbursement for DecisionDX-melanoma laboratory testing performed on 5/13/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees malignant melanoma. | Upheld | Experimental | Summary Reviewer 2
A 55-year-old female enrollee has requested reimbursement for DecisionDX-melanoma laboratory testing performed on 5/13/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees malignant melanoma. The physician reviewer found that a commercial gene expression profile test (DecisionDX-Melanoma) has been developed in patients with stage I and II cutaneous melanoma. However, there 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 according to published data available. Per the National Comprehensive Cancer Network (NCCN) guidelines, while there is interest in newer prognostic molecular techniques such as gene expression profiling to differentiate benign from malignant neoplasms, or melanomas at low versus high risk for metastasis, routine (baseline) genetic testing of primary cutaneous melanomas is not recommended. At this time, the gene test performed on 5/13/16 was not likely to be of greater benefit than available standard therapy for the evaluation of this patient. Therefore, for the reasons stated above, the services at issue were not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 36-year-old female enrollee has requested reimbursement for Botox injections received on 10/14/14. The Health Insurer has denied this request indicating that the services at issue were investigational for treatment of the enrollees medical condition.
, the patient failed numerous standard therapies for migraine, including two prophylactic classes of therapies, an anti-seizure medication and an antidepressant medication. The patient also responded to a course of Botox with a reduction of headaches per month. | Overturned | Experimental | Summary Reviewer 3
A 36-year-old female enrollee has requested reimbursement for Botox injections received on 10/14/14. 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 Botox injections were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Although Botox is not a first-line therapy for all patients with migraines, there is adequate literature supporting its use for this indication in some patients. The therapy is U.S. Food and Drug Administration (FDA) approved for migraine. In this particular case, the patient failed numerous standard therapies for migraine, including two prophylactic classes of therapies, an anti-seizure medication and an antidepressant medication. The patient also responded to a course of Botox with a reduction of headaches per month. For this reason, the services at issue were likely to be more beneficial for treatment of the patients chronic migraine 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.
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A 20-year-old female enrollee has requested reimbursement from 10/25/17 through 11/8/17 and prospective authorization and coverage for residential treatment services. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health condition.
the medical records, the patient was not stabilized and remained symptomatic beyond 10/25/17. On 10/31/17, the patient was documented as having suicidal ideation with a plan to overdose on medications and was placed on close observation. The patient was consistently documented as depressed and anxious, with restricted/flat affect, nightmares, and suicidal ideation. The patient was also documented as frequently taking, as needed, haloperidol, lorazepam, and hydroxyzine for anxiety in addition to her regularly scheduled psychiatric medications. Documentation from clinical staff on 11/8/17 indicated that the patient was not able to step down to a lower level of care due to the severity of her symptoms and safety concerns.
This patient has been diagnosed with Ehlers-Danlos syndrome. Additionally, this patient continued to report suicidal ideation and was placed on close observation. On 11/8/17, she was evaluated by the treatment team and deemed not appropriate for a lower level of care. | Overturned | Medical Necessity | Summary Reviewer
A 20-year-old female enrollee has requested reimbursement from 10/25/17 through 11/8/17 and prospective authorization and coverage for residential treatment services. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found that there is support for the medical necessity of the services at issue in this clinical setting. Based on a review of the medical records, the patient was not stabilized and remained symptomatic beyond 10/25/17. On 10/31/17, the patient was documented as having suicidal ideation with a plan to overdose on medications and was placed on close observation. The patient was consistently documented as depressed and anxious, with restricted/flat affect, nightmares, and suicidal ideation. The patient was also documented as frequently taking, as needed, haloperidol, lorazepam, and hydroxyzine for anxiety in addition to her regularly scheduled psychiatric medications. Documentation from clinical staff on 11/8/17 indicated that the patient was not able to step down to a lower level of care due to the severity of her symptoms and safety concerns. A study by Vujanovic and colleagues shows that trauma and posttraumatic stress disorder are frequently associated with suicidality and psychiatric readmission rates are high especially amongst patients with physical comorbidities such as in this patients case. This patient has been diagnosed with Ehlers-Danlos syndrome. Additionally, this patient continued to report suicidal ideation and was placed on close observation. On 11/8/17, she was evaluated by the treatment team and deemed not appropriate for a lower level of care. Therefore, residential treatment services from 10/26/17 through 11/8/17 and future services were and are medically necessary for treatment of this patients medical condition. Therefore, for the reasons stated above, the services at issue were and are medically necessary for treatment of the patients medical condition. Therefore, the Health Insurers denial should be overturned.
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A 58-year-old male enrollee has requested authorization and coverage for proton beam radiation
therapy (PBT). The Health Insurer has denied this request and reported that the requested service is
investigational for the treatment of the enrollees locally advanced esophagus cancer. | Overturned | Experimental | Summary Reviewer 2
A 58-year-old male enrollee has requested authorization and coverage for proton beam radiation
therapy (PBT). The Health Insurer has denied this request and reported that the requested service is
investigational for the treatment of the enrollees locally advanced esophagus cancer. The physician
reviewer found that PBT is not likely to be more beneficial for treatment of the patients condition than
any available standard therapy.
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A 48-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 9/15/15. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees breast examination.
patient is a 48-year-old female who has requested reimbursement for bilateral diagnostic mammogram with tomosynthesis on 9/15/15 for a 6-month calcification follow up. | Overturned | Experimental | Summary Reviewer 2
A 48-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 9/15/15. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees breast examination. The physician reviewer found this patient is a 48-year-old female who has requested reimbursement for bilateral diagnostic mammogram with tomosynthesis on 9/15/15 for a 6-month calcification follow up. The report shows calcifications were unchanged from previous studies, suggesting it is probably benign, BIRADS 3. A 2013 study by Skanne and colleagues found the use of mammography plus tomosynthesis in a screening environment resulted in significantly higher cancer detection rate and enabled radiologists to detect more invasive cancers. Recent studies also show that integrated 2D and 3D mammography reduced false positive recalls (Ciatto, et al). The current literature is sufficient to support the use of breast tomosynthesis over conventional mammogram based upon improved cancer detection rates. In this patient, the use of tomosynthesis was likely to be more beneficial for the evaluation of her medical condition than standard imaging modalities. For the reasons stated above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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The patient is a 20-year-old female with a history of depression, suicidal ideation, borderline personality disorder, anxiety disorder, and polysubstance dependence. She presented for an assessment on 9/11/20. The patient has requested reimbursement for residential treatment provided from 10/20/20 through 11/04/20. 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 patient had a suicide attempt prior to admission in which she cut herself and required sutures. On admission to the residential treatment center, she continued to have suicidal ideation and endorse hopelessness.
care. The patient was kicked out of college for her substance use and is now unemployed. The records noted that the patient was isolating herself. She had a conflictual relationship with her parents and an inability to function prior to admission to residential
occurring medical illness, substance use disorder, or psychiatric disorder. The patient was
heavily that she was expelled from school and continued to use | Overturned | Medical Necessity | Summary Reviewer
The patient is a 20-year-old female with a history of depression, suicidal ideation, borderline personality disorder, anxiety disorder, and polysubstance dependence. She presented for an assessment on 9/11/20. The patient has requested reimbursement for residential treatment provided from 10/20/20 through 11/04/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. The physician reviewer found that The American Association of Community Psychiatrists Level of Care Utilization System (LOCUS) provides a reliable framework for determining the appropriate level of care for adults needing mental health treatment. Using LOCUS, providers score patients on a scale of 1-5 using a six-pronged Dimensional Rating System. The six dimensions include: (1) risk of harm; (2) functional status; (3) medical, addictive and psychiatric comorbidity; (4) recovery environment (a. stressors and b. supports); (5) treatment and recovery history; and (6) engagement. The composite score is then used to determine the level of care needed. Applying the LOCUS framework, the patient met the criteria for residential treatment. With regard to dimension 1 (risk of harm), the records support a score of 4. The patient had a suicide attempt prior to admission in which she cut herself and required sutures. On admission to the residential treatment center, she continued to have suicidal ideation and endorse hopelessness.
In terms of dimension 2 (function), the records support a score of 4. This dimension assesses the degree to which a patient is able to fulfill social responsibilities, interacts with, maintain physical functioning and capacity for self-care. The patient was kicked out of college for her substance use and is now unemployed. The records noted that the patient was isolating herself. She had a conflictual relationship with her parents and an inability to function prior to admission to residential treatment center. With regard to dimension 3 (comorbidity), the records support a score of 3. This dimension assesses potential complications in the course of treatment due to acuity or disability related to co-occurring medical illness, substance use disorder, or psychiatric disorder. The patient was using cannabis so heavily that she was expelled from school and continued to use this and Xanax daily, despite the clear negative consequences on her health, both physically and mentally. In terms of dimension 4A (level of stress of the recovery environment), the records support a score of 4. This dimension assesses the stressors in the environment, social circumstances, and interpersonal relationships. The patient had to move back home after being expelled from college. She had serious disturbances in her family relationships and was isolating herself from social relationships. With regard to level 4B (level of support of the recovery environment), the records support a score of 3. This dimension assesses the presence of family and social support to augment the recovery environment. The patientas parents want to help the patient, but she has maintained a very conflictual relationship with them. She has also isolated herself from her other social supports. In terms of dimension 5 (treatment and recovery history), the records support a score of 4. This dimension assesses how past experiences with treatment and recovery might indicate how the patient might respond in the future. The patient was hospitalized psychiatrically following her suicide attempt and has been in outpatient treatment since then, but with minimal response to treatment thus far. With regard to dimension 6 (engagement), the records support a score of 4. This dimension assesses a patientas understanding of the illness and treatment, and ability and willingness to engage in the treatment process. The patient had trouble accepting her role in recovery and taking ownership and accountability of her own role in her conflictual relationships and course of her schooling and life. These findings give the patient a composite score of 26, which is consistent with medically monitored residence-based services. Per LOCUS, the patientas scores of 4 for risk of harm and also 4 for functional status also support treatment at Level 5 medically monitored residence-based services level of care. Therefore, residential treatment provided from 10/20/20 through 11/04/20 was medically necessary for the treatment of this patient.
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The parent of a four-year-old female enrollee has requested authorization and coverage for genetic testing. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the evaluation of the enrollees medical condition. | Overturned | Medical Necessity | Summary Reviewer
The parent of a four-year-old female enrollee has requested authorization and coverage for genetic testing. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that Ataxia is an uncommon finding in children with a large number of causes. Genetic etiology can often be identified, particularly in those with early age of onset, family history of ataxia, or consanguineous parents. In this childs case, the very early age of onset indicated a high probability of an underlying genetic cause. Studies of whole exome sequencing (WES), which is more comprehensive than the panel requested here, have shown rates of identification of underlying genetic etiology ranging from 21% to 69%, depending on age and family history of those included. The rate of positive WES in 21% of adults with ataxia suggests a significant likelihood of finding a diagnosis for this child, either by panel test or by WES. Many authors currently recommend WES either as a follow-up test to non-diagnostic ataxia panel genetic testing, or as an initial molecular test due to its comprehensiveness. Specific treatments do exist for some hereditary ataxias, and more clinical trials and therapies are anticipated, increasing the benefits of confirming a molecular diagnosis. The current medical evidence supports genetic testing in this clinical setting. Therefore, the requested genetic testing is medically necessary for the evaluation of this patient. | 0 |
A 35-year-old female enrollee has requested reimbursement for (CPT code 86343) leukocyte histamine release test (LHR) dated on 10/20/15. The Health Insurer has denied this request indicating that the requested procedure are considered investigational for treatment of the enrollees chronic idiopathic urticaria | Upheld | Experimental | Summary Reviewer 2
A 35-year-old female enrollee has requested reimbursement for (CPT code 86343) leukocyte histamine release test (LHR) dated on 10/20/15. The Health Insurer has denied this request indicating that the requested procedure are considered investigational for treatment of the enrollees chronic idiopathic urticaria The physician reviewer found the clinical utility of LHR is not well established and there are currently no national Allergy and Immunology or Dermatology guidelines recommending routine use of this test. LHR is a test that consists of basophil histamine release assay. This assay is used to detect anti-Fc-epsilon-RI-alpha antibodies. Some concerns with LHR is that there is evidence against a pathogenic role of autoantibodies to IgE or Fc-epsilon-RI and they are not specific to CU. Anti-Fc-epsilon-RI-alpha antibodies have been identified in healthy normal people and those with other autoimmune diseases. The level of these antibodies do not appear to change with the clinical disease activity. The presence of these antibodies do not appear to predict refractory disease. In this patients case, her symptoms are consistent with chronic idiopathic urticaria. Her evaluation to include LHR have all been negative. As such, (CPT code 86343) leukocyte histamine release test (LHR) that was rendered on 10/20/15 was not likely to have been more effective than current standard therapy for evaluation of this patient. Therefore, for the reasons stated above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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patient is a 45-year-old female with a history of severe Raynauds disease with ulceration.
The patient reported being diagnosed with the condition for the past four to five years with
worsening symptoms. The provider recommended Botox injections of 100 units for a quantity of
2 per 30 days for the treatment of the patients Reynards disease symptoms. The Health Insurer
has denied the requested medication as not medically necessary.
. In this case, the patient has documented findings consistent with severe
Raynauds disease including ulceration of the digits. The record reflects that the patient reported
increased vasospasm with associated pain and nail dystrophy having a significant impact on her
quality of life. The patient is currently on nifedipine 30 mg, but per a clinic note dated 3/15/23, the
effect of the medication has waned. The record reflects that the patient has experienced a good
response to Botox on her hands and feet. | Overturned | Medical Necessity | Summary
The patient is a 45-year-old female with a history of severe Raynauds disease with ulceration.
The patient reported being diagnosed with the condition for the past four to five years with
worsening symptoms. The provider recommended Botox injections of 100 units for a quantity of
2 per 30 days for the treatment of the patients Reynards disease symptoms. The Health Insurer
has denied the requested medication as not medically necessary. This denial is the subject of this
appeal and determination. The physician reviewer found that the treatment of severe and refractory
Raynauds disease must be individualized based on clinical findings, presentation, and other
studies. The medical literature contains mainly case reports and small studies supporting the use
of Botox for severe and ulcerating Raynauds disease in patients with atypical presentation and in
such an advanced stage. A randomized controlled trial by Motegi and colleagues supported the
efficacy of Botox for the treatment of Raynauds disease and indicated a decrease in ulcerations.
Further, recent medical literature supports the use of Botox for Raynauds syndrome for systemic
sclerosis (Jerjen, et al.). In this case, the patient has documented findings consistent with severe
Raynauds disease including ulceration of the digits. The record reflects that the patient reported
increased vasospasm with associated pain and nail dystrophy having a significant impact on her
quality of life. The patient is currently on nifedipine 30 mg, but per a clinic note dated 3/15/23, the
effect of the medication has waned. The record reflects that the patient has experienced a good
response to Botox on her hands and feet. The refractory nature of the patients disease and the
presence of ulcerations suggests potential loss of function if the disease continues, thus Botox is
indicated for the treatment of the patient. Therefore, the requested Botox injections of 100 units
for a quantity of two per 30 days are medically necessary for the treatment of the patient.
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A 49-year-old transgender female enrollee has requested reimbursement for tracheal shave provided on 3/26/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees gender dysphoria.
This patient has well-documented gender dysphoria. Per her medical records, she had social anxiety and depression related to being perceived as male by others. The records document clinically significant distress from having masculine features. Under these circumstances, the tracheal sh | Overturned | Medical Necessity | Summary Reviewer
A 49-year-old transgender female enrollee has requested reimbursement for tracheal shave provided on 3/26/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees gender dysphoria. The physician reviewer found that the submitted documentation supports the medical necessity of the services at issue. This patient has well-documented gender dysphoria. Per her medical records, she had social anxiety and depression related to being perceived as male by others. The records document clinically significant distress from having masculine features. Under these circumstances, the tracheal shave performed was medically necessary for the treatment of her gender dysphoria. World Professional Association for Transgender Health (WPATH) criteria for surgery state that other surgeries for assisting in body feminization include reduction thyroid chondroplasty (reduction of the Adams apple), voice modification surgery, suction-assisted lipoplasty (contour modeling) of the waist, rhinoplasty (nose correction), facial bone reduction, face-lift, and blepharoplasty (rejuvenation of the eyelid). The current medical evidence supports the services at issue in this clinical setting. Therefore, tracheal shave provided on 3/26/18 was medically necessary for the treatment of this patient. Therefore, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned. | 1 |
A 32-year-old female enrollee has requested reimbursement for prenatal testing performed on 1/10/14. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees suspected fetal abnormality.
The patients 18-week ultrasound revealed two soft markers associated with an increased risk of aneuploidy.
This patient presented with ultrasound markers associated with an | Overturned | Experimental | Summary Reviewer 2
A 32-year-old female enrollee has requested reimbursement for prenatal testing performed on 1/10/14. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees suspected fetal abnormality. The physician reviewer found in this case, the prenatal cell-free DNA screening provided on 1/10/14 was likely to be more beneficial than other modalities. The patients 18-week ultrasound revealed two soft markers associated with an increased risk of aneuploidy. The American College of Obstetricians and Gynecologists Committee on Genetics recommend women regardless of maternal age be offered cell-free DNA who present with ultrasonographic findings indicating an increased risk of aneuploidy. This patient presented with ultrasound markers associated with an increased risk of aneuploidy. As such, the testing at issue was likely to be more beneficial than other modalities. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 63-year-old female enrollee has requested reimbursement for computed tomography (CT) scan of the abdomen and pelvis performed on 12/11/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. | Overturned | Medical Necessity | Summary Reviewer
A 63-year-old female enrollee has requested reimbursement for computed tomography (CT) scan of the abdomen and pelvis performed on 12/11/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that there is sufficient support for the services at issue in this patients case. In the setting of acute/subacute abdominal pain with associated nausea and vomiting, the range of pathology is broad and includes gastrointestinal, biliary, pulmonary and genitourinary pathology. Imaging plays a key role in this setting to help direct management and treatment. CT of the abdomen and pelvis, preferably with oral and intravenous contrast, has been proven to improve the final diagnosis and management of patients presenting with abdominal pain. In this case, the CT of the abdomen and pelvis could have impacted patient management. Therefore, CT of the abdomen and pelvis performed on 12/11/18 was medically necessary for the evaluation of this patient. | 0 |
A 52-year-old male enrollee has requested authorization and coverage for implant stimulator. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees complex regional pain syndrome to his right foot. | Upheld | Experimental | Summary Reviewer 3
A 52-year-old male enrollee has requested authorization and coverage for implant stimulator. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees complex regional pain syndrome to his right foot. The physician reviewer found that the medical records provided for review indicate a condition of chronic back pain with degenerative disc disease and previous spine surgery. There is documentation regarding previous conservative care and treatment response to date but also notes little improvement with spinal cord stimulator trial. However, implanted stimulator, permanent placement is not supported unless at least 50% improvement in pain with demonstrated functional gain. Babu and colleagues reported that permanent placement outcomes are maximized when at least 50% improvement in pain and functional gain is used to measure success. Provenzano and colleagues noted the effectiveness of implanted stimulator but reflects that placement is only supported for those cases with demonstrated functional improvement. The medical records provided do not indicate that this threshold has been met in this patient. In sum, spinal cord stimulation permanent placement is not likely to be more efficacious in this patients case than the standard options available for treatment. Therefore, for the reasons stated above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 36-year-old female enrollee has requested authorization and coverage for Sunosi 75 mg tablet.
The Health Insurer has denied this request and reported that the requested medication is
investigational for the treatment of the enrollees idiopathic hypersomnia. | Upheld | Experimental | Summary Reviewer 1
A 36-year-old female enrollee has requested authorization and coverage for Sunosi 75 mg tablet.
The Health Insurer has denied this request and reported that the requested medication is
investigational for the treatment of the enrollees idiopathic hypersomnia. The physician reviewer
found that Idiopathic hypersomnia (IH) is a syndrome with no known cause. Standard treatment is
first addressing treatable causes of sleepiness and then using wake-promoting medications and
stimulants to combat daytime sleepiness. While there is a lack of published studies on the use of
solriamfetol in IH, improvement to daytime sleepiness may be extrapolated from literature
showing the efficacy of these agents in the treatment of conditions such as narcolepsy type 1. In
terms of addressing the treatable causes of sleepiness, the American Academy of Sleep Medicine
confirms the necessity of sleep-tracking by actigraphy or sleep logs prior to testing. In this case,
the records did not include enough data to exclude insufficient sleep as a cause of
hypersomnolence, and less than seven hours of sleep were confirmed before the MSLT on the
overnight sleep study. The patient's average subjective sleep time of only seven hours during the
week and eight to eight and half hours on the weekend may warrant a trial of sleep extension of
eight to nine hours per night, with confirmation using sleep tracking methods, as a first step prior
to wake-promoting medications. Current medical literature supports the use of medications
including modafinil, methylphenidate, oxybate salts, pitolisant, and clarithromycin. In this case,
the records did not document that armodafinil, which is identical to modafinil, was prescribed at
the maximum dosage of 250 mg daily, or that oxybate salts, pitolisant, and clarithromycin were
previously used or contraindicated. The records indicate that Adderall is prescribed as needed, but
without an explanation on why it, or its extended-release version, cannot be used regularly at a
higher dose if well-tolerated. In this clinical setting, there is a lack of support in current medical
literature that Sunosi is likely to be more beneficial than standard therapies such as sleep-extension,
increased dosage of current medications, or other medications recommended in current medical
literature for the treatment of idiopathic hypersomnia. Therefore, Sunosi 75 mg tablet is not likely
to be more beneficial for treatment of the patients condition than any available standard therapy.
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A 64-year-old female enrollee has requested reimbursement for FoundationOne test performed on 1/19/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees colon cancer. | Upheld | Experimental | Summary Reviewer 2
A 64-year-old female enrollee has requested reimbursement for FoundationOne test performed on 1/19/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees colon cancer. The physician reviewer found that this patient has exhibited toxicity to a standard regimen for colon cancer. 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. A study by Von Hoff and colleagues involved 86 patients where the progression-free survival (PFS) on regimen selected by molecular profiling was compared to PFS on the last chemotherapy regimen. The regimen selected by molecular profiling offered a 27% survival advantage. Accordingly, FoundationOne test performed on 1/19/17 was likely to have been of greater benefit than standard available methods of evaluating this patients medical condition. Therefore, for the reasons stated 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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The patient is a 63-year-old male who was found to have an elevated prostate-specific antigen (PSA) level. He was referred for magnetic resonance imaging (MRI) of the prostate gland, which was performed on 4/13/19. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 63-year-old male who was found to have an elevated prostate-specific antigen (PSA) level. He was referred for magnetic resonance imaging (MRI) of the prostate gland, which was performed on 4/13/19. The physician reviewer found that currently, the diagnostic pathway for prostate cancer detection is often initiated by PSA level testing and digital rectal examination. This is often followed by transrectal ultrasound guided biopsy (TRUS). However, anterior tumors within the prostate are often missed by TRUS. Further, TRUS biopsy has historically underestimated the final Gleason grading, leading to inaccurate risk stratification and selection of therapeutic options. Magnetic resonance imaging has been used for noninvasive assessment of the prostate gland since the 1980s. Initially, prostate MRI was based solely on morphologic assessment using T1-weighted and T2-weighted pulse sequences, and its role was primarily for locoregional staging in patients with biopsy proven cancer. However, it provided limited capability to distinguish between pathologic tissue and clinically insignificant prostate cancer from significant cancer. Advances in technology, however, have dramatically changed MRI imaging for prostate cancer. The center that had performed this patients MRI refers to this advanced technology as three-dimensional rendering. In fact, three-dimensional rendering is an older term to describe what is widely described as multiparametric MRI. By using
these newer techniques, which are widely accepted, one is able to obtain three-dimensional volumetric images. By obtaining images from the whole area within the body, there is a higher signal-to-noise ratio, making the images sharper and more accurate in detecting lesions. This technique also allows fusing the MRI to ultrasound and to guide TRUS. The medical evidence supports the services at issue in this clinical setting. As stated by Girometti and colleagues, Multiparametric magnetic resonance imaging is the standard of care for assessing prostate cancer. Therefore, three-dimensional rendering with interpretation and reporting of magnetic resonance imaging performed on 4/13/19 was medically necessary for the evaluation of this patient. | 1 |
A 48-year-old male enrollee has requested reimbursement for unlisted multianalyte assay with algorithmic analysis performed on 11/25/19. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. | Upheld | Medical Necessity | Summary Reviewer
A 48-year-old male enrollee has requested reimbursement for unlisted multianalyte assay with algorithmic analysis performed on 11/25/19. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that this patient has an early stage melanoma. Commercially available gene expression profiling (GEP) tests, such as DecisionDx-Melanoma testing 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. Therefore, unlisted multianalyte assay with algorithmic analysis performed on 11/25/19 was not medically necessary for the evaluation of this patient. | 0 |
A 46-year-old female enrollee has requested authorization and coverage for bone marrow
aspiration (38220). The Health Insurer has denied this request and reported that the requested
services are investigational for the treatment of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 3
A 46-year-old female enrollee has requested authorization and coverage for bone marrow
aspiration (38220). 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 according to Thurairajah and colleagues, published scientific data on bone
marrow aspirate therapy for human nonunion has been available since 1986, but to date there is no
Level I nor Level II evidence in publication. A retrospective study involving 26 patients by Lin
and colleagues was designed to compare bone marrow aspirate concentrate with cancellous
allograft to iliac crest bone graft in the treatment of nonunions. No significant difference was found
in union rate for long bone nonunions treated with to iliac crest bone graft or bone marrow aspirate
concentrate with allograft. The authors noted, Bone marrow aspirate concentrate and allograft led
to 75% successful healing in this series. Given the heterogeneity of the control group, further
prospective investigation should be conducted to more rigorously compare bone marrow aspirate
concentrate to iliac crest bone graft for nonunion treatment. Autologous cancellous bone grafting
often involves donor site morbidities and complications. The purpose of the study by Thua and
colleagues was to evaluate the initial outcome of the percutaneous injection of autologous bone
marrow after concentration for the treatment of delayed union or nonunion. The authors noted, The result of this study is encouraging. Percutaneous autologous bone marrow implantation could
be an effective and safe option for the treatment of delayed or nonunion fractures. However, more
studies are needed for definitive conclusions. The objective of a systematic review and meta-
analysis by Palombella and colleagues was to assess the current evidence for the efficacy of bone
marrow-derived cell-based approaches associated or not with bone scaffolds for the treatment of
nonunions. A total of 27 studies were analyzed. The authors noted, The results indicate that
marrow aspirate concentrate or marrow aspirate concentrate/scaffold might be considered as the
primary choice to treat nonunions with a successful healing rate at a midterm follow-up. Moreover,
this meta-analysis highlighted that the presence of a scaffold positively influences the healing rate
at a long-term follow-up. More case-control studies are still needed to support the clinical
improvement of cell-based therapies against autografts, up to now considered as the gold standard
for the treatment of nonunions. In sum, percutaneous bone marrow aspirate for the treatment of
delayed or nonunion fractures is encouraging and could be an effective and safe option. However,
at this time, there is a lack of Level I or Level II evidence in publication supporting its use. More
studies are still needed to support the clinical improvement of cell-based therapies against
autografts. Therefore, the requested bone marrow aspiration (38220) is not likely to be more
beneficial than any other available standard treatments for the enrollees medical condition.
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The parent of a 17-year-old male enrollee has requested reimbursement and prospective authorization and coverage for mental health residential treatment services provided from 4/9/14 forward. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees polysubstance abuse and parent-child relational problem.
that the patient had a significant substance abuse history and he had just gone away without leave from his previous placement. | Upheld | Medical Necessity | Summary Reviewer
The parent of a 17-year-old male enrollee has requested reimbursement and prospective authorization and coverage for mental health residential treatment services provided from 4/9/14 forward. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees polysubstance abuse and parent-child relational problem. The physician reviewer found that the records submitted for review indicate that the patient had a significant substance abuse history and he had just gone away without leave from his previous placement. However, there is no indication that placement in this facility was geared to address motivational concerns or that the patient had any symptoms requiring 24-hour support and intervention. According to the American Psychiatric Association (APA) practice guidelines, patients with substance use disorders should be treated in the least restrictive setting which is likely to be safe and effective. There is a lack of evidence that this patients substance abuse presented an imminent safety risk or that he could not have been managed effectively on an ambulatory basis. Further, there is no documentation of withdrawal symptoms. Overall, the chart reviewed fails to support the medical necessity of residential substance abuse services from 4/9/14 through 10/19/14 and ongoing. Based on the foregoing discussion, I have concluded that 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 56-year-old female enrollee has requested reimbursement for Oncotype DX colon cancer assay completed on 8/19/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees colon cancer. | Overturned | Experimental | Summary Reviewer 2
A 56-year-old female enrollee has requested reimbursement for Oncotype DX colon cancer assay completed on 8/19/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees colon cancer. The physician reviewer found that this patient had stage II colon cancer. Although Oncotype DX colon cancer assay provides prognostic data, to date, it does not provide predictive data for the benefit of chemotherapy. Per the medical evidence, the clinical utility of gene expression assays, including the 12-gene recurrence score, is uncertain. Information is lacking regarding the extent to which assay results do or do not classify patients into distinct groups with clinical relevance. National Comprehensive Cancer Network guidelines state that there are insufficient data to recommend the use of multigene assays, such as the Oncotype DX colon cancer, to determine adjuvant therapy. The perforation of this patients tumor despite negative nodes would favor treatment with chemotherapy. As such, the use of Oncotype DX colon cancer assay on 8/19/15 was not likely to have been more beneficial than using standard factors in determining the need for adjuvant therapy for the evaluation of this patient. Therefore, for the reasons stated above, the services at issue were not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 29-year-old female enrollee has requested reimbursement for human papilloma virus (HPV) testing performed on 9/29/20. The Health Insurer indicates that the services at issue were investigational for the evaluation of the enrollees medical condition. Therefore, the Health Insurer has denied reimbursement for the services at issue.
the patient has a history of high-grade HPV testing in 2017. Her testing in 2020 showed atypical squamous cells of undetermined significance (ASCUS) cytology with HPV. On 9/29/20, the records noted that she was evaluated with a Pap smear one year prior, and her gynecologist recommended colposcopy following an abnormal Pap smear. There is no clinical | Overturned | Experimental | Summary Reviewer 2
A 29-year-old female enrollee has requested reimbursement for human papilloma virus (HPV) testing performed on 9/29/20. The Health Insurer indicates that the services at issue were investigational for the evaluation of the enrollees medical condition. Therefore, the Health Insurer has denied reimbursement for the services at issue. The physician reviewer found that the patient has a history of high-grade HPV testing in 2017. Her testing in 2020 showed atypical squamous cells of undetermined significance (ASCUS) cytology with HPV. On 9/29/20, the records noted that she was evaluated with a Pap smear one year prior, and her gynecologist recommended colposcopy following an abnormal Pap smear. There is no clinical documentation from her gynecology visit, and documentation states that the patient was lost to follow-up at this time. The ASCCP guidelines support clinical decision making in situations where patients have been lost to follow-up. Given the patients history of high-grade HPV followed by ASCUS testing, a one-year follow-up co-test is appropriate and consistent with standard therapy. Therefore, HPV testing performed on 9/29/20 was likely to have been more beneficial for evaluation of the patients condition than any available standard therapy.
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A 66-year-old female enrollee has requested authorization and coverage for Inspire upper airway stimulation system. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas obstructive sleep apnea.
The patient has obstructive sleep apnea and has no nasal obstruction. She has not been able to tolerate continuous positive airway pressure therapy. | Overturned | Experimental | Summary Reviewer 1
A 66-year-old female enrollee has requested authorization and coverage for Inspire upper airway stimulation system. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas obstructive sleep apnea. The physician reviewer found that the current medical evidence supports the requested services in this clinical setting. The patient has obstructive sleep apnea and has no nasal obstruction. She has not been able to tolerate continuous positive airway pressure therapy. The Inspire device has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of obstructive sleep apnea. At this point, the patient is a candidate for the Inspire device, given the intolerance to continuous positive airway pressure therapy, anterior posterior collapse, no central apnea, and body mass index and apnea-hypopnea index within FDA criteria. Therefore, Inspire upper airway stimulation system is likely to be more beneficial than any available standard therapy.
| 1 |
A 58-year-old female enrollee has requested reimbursement for nerve stimulation treatment provided on 3/12/18, 4/10/18 and 6/12/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee, who reported a history of urgency and frequency. | Upheld | Experimental | Summary Reviewer 3
A 58-year-old female enrollee has requested reimbursement for nerve stimulation treatment provided on 3/12/18, 4/10/18 and 6/12/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee, who reported a history of urgency and frequency. The physician reviewer found that intractable lower urinary tract symptoms and painful bladder/urethral syndrome related to interstitial cystitis can be clinically difficult to treat. Treatment options often are limited and have variable results. Patients often receive multimodal treatment, including proceeding to secondary and tertiary treatment options. Percutaneous tibial nerve stimulation is considered as a tertiary treatment option for intractable lower urinary tract symptoms and painful bladder syndrome with urgency frequency syndrome. There is some support for the requested services in this clinical setting. Therefore, nerve stimulation treatment provided on 3/12/18, 4/10/18 and 6/12/18 was likely to have been of greater benefit than other treatment options. 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 49-year-old female enrollee has requested reimbursement for a digital breast tomosynthesis that was performed on 3/22/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for the enrollees breast examination | Overturned | Experimental | Summary Reviewer 1
A 49-year-old female enrollee has requested reimbursement for a digital breast tomosynthesis that was performed on 3/22/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for the enrollees breast examination The physician reviewer found there is limited peer-reviewed literature that supports the use of three dimensional breast tomosynthesis (DBT) over currently available techniques. Although DBT may be a promising technique, its clinical efficacy has yet to be substantiated as superior to currently available standard medical therapies in peer-reviewed literature. Thus, the digital breast tomosynthesis portion was not likely to be superior to available standard modalities for evaluation of this patient. Based upon the information set forth above, the service at issue was not likely to be more beneficial than any available standard therapy for evaluation of the patient. The Health Insurers denial should be upheld.
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A 21-year-old male enrollee has requested reimbursement for corneal collagen crosslinking performed on 3/13/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees keratoconus. | Overturned | Experimental | Summary Reviewer 3
A 21-year-old male enrollee has requested reimbursement for corneal collagen crosslinking performed on 3/13/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees keratoconus. The physician reviewer found that there is strong evidence in the literature that collagen crosslinking can halt the progression of keratoconus. It is U.S. Food and Drug Administration (FDA) approved for this indication. Given the patients age, he is at significant risk for progression. Given his history of progressive blurriness, particularly in the right eye which had not yet undergone crosslinking, it highly suggests progression in the right eye. Therefore, corneal collagen crosslinking performed on 3/13/17 was likely to have been more effective than other available treatment options. Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 50-year-old male enrollee has requested authorization and coverage for Korlym 300 mg tablets. 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.
. Five patients demonstrated signs of objective response (reduced tumor
. Three patients experienced subjective improvement (improved extraocular muscle function or relief from headache). | Overturned | Medical Necessity | Summary Reviewer
A 50-year-old male enrollee has requested authorization and coverage for Korlym 300 mg tablets. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the current medical evidence supports the requested medication in this clinical setting. Meningiomas are more commonly positive for progesterone receptors than for estrogen receptors. Several studies have been conducted on long-term oral therapy of unresectable meningiomas with the antiprogesterone mifepristone (RU486). In the study by Grunberg and colleagues, fourteen patients received mifepristone in daily doses of 200 mg for periods ranging from two to greater than 31 months (greater than or equal to six months in 12 patients). Five patients demonstrated signs of objective response (reduced tumor measurement on computerized tomography scan or magnetic resonance imaging, or improved visual field examination). Three patients experienced subjective improvement (improved extraocular muscle function or relief from headache). The side effects of long-term mifepristone therapy were noted to have been mild. The authors noted that long-term therapy with mifepristone may have efficacy in cases of unresectable benign meningioma. There is sufficient support for the requested medication in this clinical setting. Therefore, Korlym 300 mg tablets are medically necessary for the treatment of this patient. | 1 |
A 63-year-old female has requested reimbursement for Anser ADA testing provided on 4/25/16. 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 63-year-old female has requested reimbursement for Anser ADA testing provided on 4/25/16. 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 there is insufficient medical evidence to support the effectiveness of Anser ADA compared with conventional courses of action in the management of ulcerative colitis. Patients being treated with adalimumab may experience loss of response, but the appropriate method for determination of the cause for loss of response is not clear. The published studies on the use of anti-adalimumab antibodies and serum levels are retrospective and/or observational in nature. These small studies demonstrated, at best, correlations between treatment failure and the presence of anti-adalimumab antibodies, which do not allow firm conclusions regarding cause and effect. Prospective controlled trials providing evidence for the effectiveness of anti-adalimumab antibody testing and serum level testing as part of a clinical management strategy are lacking. Therefore, the clinical literature has not established the superior efficacy of Anser ADA testing performed on 4/25/16. 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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