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A 27-year-old female enrollee has requested authorization and coverage for E1399 durable
medical equipment RT300 FES arm therapy system. The Health Insurer has denied this request
and reported that the requested device is investigational for the treatment of the enrollees
medical condition.
tone abnormalities related to a
brain lesion that was resected in April
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Upheld
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Experimental
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Summary Reviewer 1
A 27-year-old female enrollee has requested authorization and coverage for E1399 durable
medical equipment RT300 FES arm therapy system. The Health Insurer has denied this request
and reported that the requested device is investigational for the treatment of the enrollees
medical condition. The physician reviewer found that a functional electrical stimulation cycle
ergometer is not proven to improve function or other outcomes in the setting of this patients
condition (relatively mild hemiparesis, sensory dysfunction and tone abnormalities related to a
brain lesion that was resected in April 2021). A recent meta-analysis in the setting of subacute
stroke by Ambrosini and colleagues did not find that functional electrical stimulation-induced
cycling improved outcomes better than usual care for subacute stroke survivors. The use of this
type of device is not an evidence-based component of non-progressive brain injury
management, rehabilitation, or prevention of complications, as noted on multiple recent
reviews. The device in question is not likely to be more beneficial for treatment of the patients
medical condition than any available standard therapy, which would include, but not be limited
to, occupational therapy, independent exercise and splinting, even if a full neurological and
functional recovery is not expected to be elicited by these standard therapies. Therefore, the
requested for E1399 durable medical equipment RT300 FES arm therapy system is not likely to
be more beneficial than any available standard therapy.
| 1 |
A 46-year-old female enrollee has requested reimbursement for injection of platelet-rich plasma performed on 12/21/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition.
received platelet-rich plasma injections into the bands of plantar fascia of both heels to enhance healing
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Upheld
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Experimental
|
Summary Reviewer 3
A 46-year-old female enrollee has requested reimbursement for injection of platelet-rich plasma performed on 12/21/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition. The physician reviewer found that this patient received platelet-rich plasma injections into the bands of plantar fascia of both heels to enhance healing and relieve chronic pain. Gonnade and colleagues compared injections of platelet-rich plasma with phonophoresis and kinesiotaping for chronic plantar fasciitis. The study concluded that therapeutic quality autologous platelet-rich plasma injection has regenerative effect with long and better efficacy in pain management of chronic recalcitrant plantar fasciitis than phonophoresis and kinesiotaping. The study by Shetty and colleagues compared platelet-rich plasma injection with corticosteroid injections. The conclusion was that both platelet-rich plasma injections and corticosteroids are safe and effective treatments for chronic recalcitrant plantar fasciitis. Both options for chronic plantar fasciitis showed superior results to placebo treatment. However, platelet-rich plasma injections showed longer-term results and less need for reinjection or surgery, which made platelet-rich plasma injections superior to corticosteroid injections. Thus, injection of platelet-rich plasma performed on 12/21/18 was likely to have been of greater benefit than other treatment options.
| 1 |
A 63-year-old female enrollee has requested reimbursement for breast tomosynthesis (three-dimensional mammogram) performed on 10/31/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic.
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Overturned
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Experimental
|
Summary Reviewer 3
A 63-year-old female enrollee has requested reimbursement for breast tomosynthesis (three-dimensional mammogram) performed on 10/31/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic. The physician reviewer found that breast tomosynthesis is a technique that was developed several years ago as a problem solving adjunct to routine mammography. Applying the same basic concept as computed tomography (CT) scanning, 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 dense breasts. However, in this patients case, there were no problems to be resolved. The patient did not have dense breasts, a mass, palpable lumps, or suspicious calcifications. A routine mammogram would have been sufficient in this clinical setting. Tomosynthesis has not been shown to provide significant increased value in patients who do not have dense tissue that could obscure an abnormality, especially when there has been no change when compared to multiple prior mammograms. Thus, breast tomosynthesis (three-dimensional mammogram) performed on 10/31/16 was not likely to have been more efficacious than other modalities for evaluating this patient. Based upon the information set forth above, the service at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 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.
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Upheld
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Experimental
|
Summary Reviewer 2
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 the submitted records fail to demonstrate the superior efficacy of the services at issue. The current literature has not established that percutaneous tibial nerve stimulation is of greater benefit than standard methods of treating this patients condition. This patient may benefit from medications, hydrodistention, intravesical therapy and pelvic floor biofeedback. Per the records, first-line and second-line treatments have not been systematically trialed and exhausted. In sum, nerve stimulation treatment provided on 3/12/18, 4/10/18 and 6/12/18 was not likely to have been more efficacious 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.
| 1 |
A 27-year-old female insured has requested reimbursement for the respiratory virus panel
testing (CPT 87633, 87798, 87798-59) provided on 7/21/22. The Health Insurer has denied this
request indicating that the services at issue were considered investigational for evaluation of the
insureds respiratory illness and shortness of breath.
the respiratory virus panel services performed on 7/2/122 in the emergency
room identified a parainfluenza virus.
In the case at hand, the patient presented to
the emergency room with shortness of breath and cough and, just prior to the visit, reported not
feeling well. Further, the patients medical records indicate that the patient had treated with
amoxicillin for only five days prior without symptom improvement.
|
Upheld
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Experimental
|
Summary Reviewer 1
A 27-year-old female insured has requested reimbursement for the respiratory virus panel
testing (CPT 87633, 87798, 87798-59) provided on 7/21/22. The Health Insurer has denied this
request indicating that the services at issue were considered investigational for evaluation of the
insureds respiratory illness and shortness of breath. The physician reviewer found that the
records reflect that the respiratory virus panel services performed on 7/2/122 in the emergency
room identified a parainfluenza virus. However, the respiratory virus panel testing did not meet
the American Thoracic Society criteria for this type of testing (Evans, et al.). Medical literature
has indicated that respiratory virus panel testing is appropriate to test when there is a suspicion
of immune compromise, a high risk of complications from the infection and when the testing
could be used to direct therapy (Calderaro, et al.). In the case at hand, the patient presented to
the emergency room with shortness of breath and cough and, just prior to the visit, reported not
feeling well. Further, the patients medical records indicate that the patient had treated with
amoxicillin for only five days prior without symptom improvement. The record lacks
documentation of concerning immune compromise, complication risk, or the need for the panel
testing to direct therapy. Therefore, the respiratory virus panel testing (CPT 87633, 87798, 87798-
59) provided on 07/21/22 was not likely to have been more beneficial than any other available
standard treatment for the evaluation of the patients condition.
| 1 |
patient is a 63-year-old female with psoriasis predominantly on her hands/feet-palmoplantar variety. She has requested authorization and coverage for Otezla.
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Overturned
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Medical Necessity
|
Summary Reviewer
The patient is a 63-year-old female with psoriasis predominantly on her hands/feet-palmoplantar variety. She has requested authorization and coverage for Otezla. The physician reviewer found that the current medical evidence supports the requested medication in this clinical setting. Based on the psoriasis treatment guidelines put forth by the American Academy of Dermatology-National Psoriasis Foundation, patients who have psoriasis affecting between 3-10% (moderate) and greater than 10% (severe) of their body surface area are candidates for phototherapy and systemic medical therapy. There are no step therapy guidelines recommended in this context, and the choice of therapy should be made at the discretion of the treating physician with attention paid to patient comorbidities. Otezla is U.S. Food and Drug Administration (FDA) approved and indicated for treatment of moderate-to-severe psoriasis and has Level A evidence to support its efficacy. Given that the patient has documented evidence of moderate-to-severe disease, it would be medically appropriate to pursue this therapy. Therefore, Otezla is medically necessary for the treatment of this patient.
| 1 |
A 20-year-old female enrollee has requested reimbursement for residential treatment center services provided from 11/5/16 through 11/23/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition.
. In this case, the patients alcoholism and benzodiazepine dependence were impairing her daily routine and contributing to significant impairment across multiple domains of functionality. She reported an early age of first use, which is associated with more severe cases of alcoholism and poorer outcomes. She reported to drinking up to five alcoholic beverages daily and consuming up to 60 mg per week of alprazolam and 75 mg of zolpidem. She experienced family strain and interpersonal discord due to her substance use. Further, the patient had co-occurring depression, anxiety and thyroid disease. Her mental illness was treated with a complex regimen including a mood stabilizer, second generation atypical antipsychotic, dual-acting serotonergic and
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Overturned
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Medical Necessity
|
Summary Reviewer
A 20-year-old female enrollee has requested reimbursement for residential treatment center services provided from 11/5/16 through 11/23/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found the residential treatment center services provided from 11/5/16 through 11/23/16 were medically necessary for treatment of the patients medical condition. The American Psychiatric Association recommends residential treatment for individuals who do not meet clinical criteria for hospitalization but whose lives and social interactions have come to focus exclusively on substance use and who currently lack sufficient motivation and/or substance-free social supports to remain abstinent in an ambulatory setting. In this case, the patients alcoholism and benzodiazepine dependence were impairing her daily routine and contributing to significant impairment across multiple domains of functionality. She reported an early age of first use, which is associated with more severe cases of alcoholism and poorer outcomes. She reported to drinking up to five alcoholic beverages daily and consuming up to 60 mg per week of alprazolam and 75 mg of zolpidem. She experienced family strain and interpersonal discord due to her substance use. Further, the patient had co-occurring depression, anxiety and thyroid disease. Her mental illness was treated with a complex regimen including a mood stabilizer, second generation atypical antipsychotic, dual-acting serotonergic and noradrenergic enhancing medication, and a sedating antidepressant. Additionally, the patients home environment was not supportive to recovery and she had no sober peer support network. She had been treated at various levels of care but had been unable to maintain sobriety in the outpatient setting. On 11/3/16, there was concern of an eating disorder. On 11/4/16, there was further discussion of her affective illness with consideration given to the bipolar spectrum. She was not sleeping well and trazodone was prescribed. Levothyroxine was started that day as well. Additionally, the patient had not completed the family program, which was set for the following week, while lithium was increased on 11/21/16 for persistent irritability. In sum, the record suggests that the patient had not consolidated the treatment gains necessary to succeed in a less restrictive setting as of 11/5/16. Further, the patient remained engaged in active treatment during the entire admission, which also served to help clarify the diagnostic assessment, engage family in the therapeutic process and arrange appropriate aftercare. Based on the relevant history, severity of the addictive disease and concerning psychiatric comorbidity, effective treatment could not have been safely and adequately delivered in a setting less restrictive than the residential level of care at the time. The services and setting were safe, appropriate and consistent with good practice, while the duration of treatment aligned with community standards. Additionally, the services provided at the time were reasonably expected to improve her condition and prevent a more serious episode of illness. Considering the clinical presentation and perusal of the relevant peer-reviewed literature, the services at issue were medically necessary for treatment of the patients medical condition. Therefore, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
The patient is a 19-year-old female with a history of mood disorder and attention deficit/hyperactivity disorder. The patient was admitted to a residential treatment center on 2/04/15 due to worsening anxiety, family disturbances, low self-esteem, and depression. The patient was treated with individual, group, and family therapy along with medication management of fluoxetine. The patient has requested reimbursement for psychiatric residential treatment provided from 2/04/15 through 11/30/15. 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 did not have a history of suicide attempts. She did not have suicidal or homicidal ideation.
3. The patient was struggling to maintain good grades. The patient was able to maintain her activities of daily living.
The patient had comorbidities of attention deficit/hyperactivity disorder and borderline traits which adversely affected her
The patient had interpersonal struggles in the home. This has had
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Upheld
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Medical Necessity
|
Summary Reviewer
The patient is a 19-year-old female with a history of mood disorder and attention deficit/hyperactivity disorder. The patient was admitted to a residential treatment center on 2/04/15 due to worsening anxiety, family disturbances, low self-esteem, and depression. The patient was treated with individual, group, and family therapy along with medication management of fluoxetine. The patient has requested reimbursement for psychiatric residential treatment provided from 2/04/15 through 11/30/15. 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 Child and Adolescent Level of Care Utilization System (CALOCUS). This is an accepted, national standard for determining the appropriate level of care for children and adolescents. The patient met the following criteria based on the submitted records. In terms of risk of harm, the records support a score of 1. The patient did not have a history of suicide attempts. She did not have suicidal or homicidal ideation. With regards to functional status, the records support a score of 3. The patient was struggling to maintain good grades. The patient was able to maintain her activities of daily living. With regards to comorbidity, the records support a score of 3. The patient had comorbidities of attention deficit/hyperactivity disorder and borderline traits which adversely affected her mood. In terms of environmental stress of the recovery environment, the records support a score of 3. The patient had interpersonal struggles in the home. This has had a significant impact on her living environment. With regards to environmental support, the records support a score of 2. The patients parents were supportive of the patient and were willing to participate in treatment. In terms of resiliency, the records support a score of 3. The patient was seeing a therapist for a year. She had an equivocal response to therapy. With regards to acceptance and engagement, the records support a score of 2. The patient was cooperative with staff and would engage in treatment. Thus, the records support a composite score of 17. Based on these criteria, the patient met criteria for an intensive outpatient program and could have been treated in a less restrictive environment. Thus, psychiatric residential treatment provided from 2/04/15 through 11/30/15 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 |
A 41-year-old female enrollee has requested reimbursement for MyRisk genetic testing performed on 1/24/17. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for evaluation of the enrollee, who has a family history of cancer.
has a close relative with ovarian cancer. However, this patient has requested reimbursement for the
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Overturned
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Medical Necessity
|
Summary Reviewer
A 41-year-old female enrollee has requested reimbursement for MyRisk genetic testing performed on 1/24/17. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for evaluation of the enrollee, who has a family history of cancer. The physician reviewer found the submitted documentation supports the medical necessity of a portion of the services at issue. BRCA testing guidelines recommend BRCA testing for this patient who has a close relative with ovarian cancer. However, this patient has requested reimbursement for the MyRisk panel. This is a 25-gene panel that includes BRCA testing, but also a variety of other suspected risk genes. Although many of these other gene mutations are of interest and are being studied, for the most part, they have as yet not been found to be significant enough to be the basis for clinical decisions for the carriers or their family members. Such testing is not included in the guidelines from the major organizations. Therefore, BRCA testing was likely to have been more effective than other methods of evaluating this patient. However, the current medical evidence has not established the superior efficacy of the remainder of the testing performed. Therefore, a portion of the services at issue was medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be partially overturned.
| 1 |
The patient is a 59-year-old female who was admitted to residential treatment for worsening depressive symptoms on 1/05/20. At the time, she endorsed low mood as well as many neurovegetative impairments, including increased sleep, decreased energy and anhedonia.
. The patient reported that she had not had employment for over a year.
She has major medical comorbidity, including history of head trauma/closed head injury as well as stage IV vaginal cancer.
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Upheld
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Medical Necessity
|
Summary Reviewer
The patient is a 59-year-old female who was admitted to residential treatment for worsening depressive symptoms on 1/05/20. At the time, she endorsed low mood as well as many neurovegetative impairments, including increased sleep, decreased energy and anhedonia. The physician reviewer found that based on the limited information noted above, the patient does not meet medical necessity criteria for residential treatment. There is no evidence of suicidality. There is no evidence of functional decline. There was no evidence of psychosis or disorganization.
The American Association of Community Psychiatrists Level of Care Utilization System (LOCUS) provides a reliable framework for determining the appropriate level of care for adults needing mental health treatment. Using LOCUS, providers score patients on a scale of 1-5 using a six-pronged Dimensional Rating System. The six dimensions include: (1) risk of harm; (2) functional status; (3) medical, addictive and psychiatric comorbidity; (4) recovery environment (a. stressors and b. supports); (5) treatment and recovery history; and (6) engagement. The composite score is then used to determine the level of care needed.
In terms of risk of harm, the records support a score of 2. She had a low risk of harm given lack of suicidality or self-injurious behaviors.
With regard to functional status, the records support a score of 3. The patient reported that she had not had employment for over a year.
In terms of comorbidity, the records support a score of 4. She has major medical comorbidity, including history of head trauma/closed head injury as well as stage IV vaginal cancer.
With regard to level of stress of the recovery environment, the records support a score of 2. Her recovery environment is minimally stressful based on the information provided. She reported a close relationship with her daughter.
In terms of level of support of the recovery environment, the records support a score of 2. The documentation noted that the patient had a psychiatrist and therapist.
With regard to resilience and treatment history, the records support a score of 3. She has seen may providers, without complete remission of her symptoms.
In terms of engagement and recovery, the records support a score of 2. The patient has been adherent with treatment plan, including medication.
Thus, her composite score is 18. Based on LOCUS criteria, she did not meet criteria for residential treatment level of care. Therefore, residential treatment provided from 1/05/20 through 1/09/20 was not medically necessary for the treatment of this patient.
| 1 |
The patient is a 52-year-old female who underwent a screening colonoscopy on 5/5/22. The
patient has requested reimbursement for anesthesia for lower intestinal endoscopic procedure
on 5/5/22. The Health Insurer has denied this request and reported the service at issue was not
medically necessary for the treatment of this patient.
|
Upheld
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Medical Necessity
|
Summary Reviewer
The patient is a 52-year-old female who underwent a screening colonoscopy on 5/5/22. The
patient has requested reimbursement for anesthesia for lower intestinal endoscopic procedure
on 5/5/22. The Health Insurer has denied this request and reported the service at issue was not
medically necessary for the treatment of this patient. The physician reviewer found that the
submitted documentation does not support the medical necessity of the service at issue. The
American Society for Gastrointestinal Endoscopy (ASGE) Standards of Practice Committee noted
that the combination of an opioid and benzodiazepine is a safe and effective regimen for
achieving minimal to moderate sedation for upper endoscopy and colonoscopy in patients
without risk factors for sedation-related adverse events. The authors recommended that,
anesthesia provideradministered sedation be considered for complex endoscopic procedures
or patients with multiple medical comorbidities or at risk for airway compromise. The guidelines
also noted, Minimal and/or moderate sedation can be delivered safely by endoscopists to
patients who are American Society of Anesthesiologists (ASA) Class I, II, or III. Other candidates
for minimal or moderate sedation include those with a history of previously successful
procedures with moderate sedation and an expectation for moderate sedation as well as those
undergoing a procedure that is expected to be uncomplicated or routine. Vargo and colleagues
concluded, Use of anesthesia professionals does not appear to bring a safety benefit to patients
receiving colonoscopy and is associated with an increased serious adverse events risk for ASA I,
II, and III patients undergoing esophagogastroduodenoscopy. Wernli and colleagues reported
that the use of anesthesia service was associated with a 13% increase in the risk of any
complication within 30 days and was associated specifically with an increased risk of perforation,
hemorrhage, abdominal pain, complications secondary to anesthesia, and stroke. The authors
further noted that for most outcomes, there were no differences in risk with anesthesia services
by polypectomy status, however, the risk of perforation associated with anesthesia services was
increased only in patients with a polypectomy. In this case, the patient presented for and
underwent a routine colonoscopy. She did not have any significant heart, lung, kidney, or liver
disease. There was no documentation of a history of alcohol or substance abuse. There was no
detailed description of a previous history of difficulties with anesthesia or sedation with past
colonoscopies documented in the submitted records. The records did not note an ASA risk
classification score or a Mallampati airway grade. The literature does not support the use of
monitored anesthesia care in a patient who does not have significant health conditions or airway
concerns. Rather, the guidelines suggest there is high quality evidence to support the use of mild
to moderate sedation in healthy uncomplicated endoscopy procedures, such as in this case.
Based on the current medical evidence, the service at issue was not medically indicated.
Therefore, anesthesia for lower intestinal endoscopic procedure on 5/5/22 was not medically
necessary for the treatment of this patient.
| 1 |
A 29-year-old male enrollee has requested reimbursement for chiropractic modalities CPT codes (97012, 97110, 97140 and 99213) for the following dates: 1/22/16, 1/25/16, 1/27/16, 1/29/16, and 2/1/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees neck and upper back pain.
The patient did make functional change with objective measures such as neck disability index and upper extremity functional scale.
|
Upheld
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Medical Necessity
|
Summary Reviewer
A 29-year-old male enrollee has requested reimbursement for chiropractic modalities CPT codes (97012, 97110, 97140 and 99213) for the following dates: 1/22/16, 1/25/16, 1/27/16, 1/29/16, and 2/1/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees neck and upper back pain. The physician reviewer found the submitted records do not demonstrate the medical necessity of the services at issue. There is no high grade scientific evidence to support passive physical modalities such as traction and massage/myofascial release to neck and upper back complaints as indicated in this case. The patient did make functional change with objective measures such as neck disability index and upper extremity functional scale. However, there is no evidence that the patient would not have made functional changes with only the approved services and not the adjunct therapies. Treatment dependence on passive modalities such as massage should be avoided. Only when there is evidence of a lack of effectiveness should relaxation massage be offered. Physical modalities such as specific neck exercises for range of motion and strengthening are also recommended. There is strong evidence that exercise programs are superior to therapies that do not include exercise. For the reasons stated above, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 60-year-old male enrollee has requested reimbursement for CPT 81529, which is an oncology
(cutaneous melanoma, mRNA, gene expression profiling by real-time RT-PCR of 31 genes (28
content and three housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm
reported as recurrence risk including likelihood of sentinel lymph node metastasis, on 3/8/22.
The Health Insurer has denied this request and reported that the service at issue was
investigational for the evaluation of the enrollees melanoma.
In this case, a dermatopathology report dated 2/25/22
described the clinicopathologic features of the initial tumor on the posterior upper left arm as
Clark level II, 0.3 mm depth, without ulceration, lymphovascular
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Upheld
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Experimental
|
Summary Reviewer 2
A 60-year-old male enrollee has requested reimbursement for CPT 81529, which is an oncology
(cutaneous melanoma, mRNA, gene expression profiling by real-time RT-PCR of 31 genes (28
content and three housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm
reported as recurrence risk including likelihood of sentinel lymph node metastasis, on 3/8/22.
The Health Insurer has denied this request and reported that the service at issue was
investigational for the evaluation of the enrollees melanoma. The physician reviewer found that
for a thin melanoma, pathologic stage pT1a, the standard treatment involves wide excision of
the lesion site with appropriate margins. In this case, a dermatopathology report dated 2/25/22
described the clinicopathologic features of the initial tumor on the posterior upper left arm as
Clark level II, 0.3 mm depth, without ulceration, lymphovascular invasion, perineural invasion, or
regression, which is otherwise a low risk tumor. The GEP test resulted in a class 1a score. Under
the National Comprehensive Cancer Network (NCCN) guidelines, standard treatment in this
clinical setting would be re-excision with appropriate margins, which was performed on 4/15/22. The NCCN guidelines for cutaneous melanoma state that it is unclear whether GEP platforms
provide clinically actionable prognostic information when compared with known
clinicopathologic factors as described above. The impact of these tests on treatment
recommendations has not been established. It also remains unclear whether GEP tests can
reliably predict outcome across the risk spectrum of cutaneous melanoma, and prospective
validation studies are necessary to more accurately define the clinical utility of GEP testing as
part of the multidisciplinary decision-making process. Grossman and colleagues report that more
evidence is needed to support using GEP testing to inform recommendations about sentinel
lymph node biopsy, follow-up, or other adjuvant treatment. The authors further recommend
against routine use of GEP testing to direct patient management until prospective studies support
their clinical utility. In a meta-analysis of GEP tests including the DecisionDX-Melanoma test,
Marchetti and colleagues concluded that the prognostic ability of GEP tests appeared to be poor
at correctly identifying recurrence in patients with stage I disease, suggesting limited potential
for clinical utility in these patients. In this clinical setting, a DecisionDx-Melanoma GEP test was
not likely to have been more beneficial than standard clinical care treatment involving re-excision
with appropriate margins followed by routine dermatologic surveillance per the NCCN guidelines.
Therefore, CPT 81529, which is an oncology (cutaneous melanoma, mRNA, gene expression
profiling by real-time RT-PCR of 31 genes (28 content and three housekeeping), utilizing formalin-
fixed paraffin-embedded tissue, algorithm reported as recurrence risk including likelihood of
sentinel lymph node metastasis, on 3/8/22, was not likely to have been more beneficial for
evaluation of the patients condition than any available standard therapy.
| 1 |
The patient is a 10-year-old male with a diagnosis of autism. The patients parent states that the
patients therapy was terminated due to non-coverage, so no additional records are available. The
patients parent has requested reimbursement and prospective authorization and coverage for
occupational therapy. The Health Insurer has denied the services at issue as not medically
necessary.
In this case, the patient started
occupational therapy for the habilitative treatment of deficiencies associated with an autism
spectrum disorder. Specifically, the patient has motor coordination problems and deficits in ADLs,
which
|
Overturned
|
Medical Necessity
|
Summary
The patient is a 10-year-old male with a diagnosis of autism. The patients parent states that the
patients therapy was terminated due to non-coverage, so no additional records are available. The
patients parent has requested reimbursement and prospective authorization and coverage for
occupational therapy. The Health Insurer has denied the services at issue as not medically
necessary. This denial is the subject of this appeal and determination. The physician reviewer
found that on review of the medical records and current medical literature occupational therapy
services provided from 2/22/23 through 2/28/24 were and are medically necessary for treatment
of this patient. The use of occupational therapy services will help address the patients ADLs,
sensory integration, and coordination, as well as gross and fine motor skills. Continued
occupational therapy services can help establish new performance baselines for this patient while
the developing central nervous system still has neuroplasticity. In this case, the patient started
occupational therapy for the habilitative treatment of deficiencies associated with an autism
spectrum disorder. Specifically, the patient has motor coordination problems and deficits in ADLs,
which are planned to be addressed with the requested occupational therapy. Occupational therapy
is the most appropriate treatment modality to address the patients deficits (Campi, et al.). Given
these findings, the occupational therapy (CPT codes 99214, 97530, 97535, 97166, and 97112)
from 2/22/23 through 2/28/24 was and is medically necessary for the treatment of this patient.
| 1 |
A 38-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 7/13/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
|
Overturned
|
Experimental
|
Summary Reviewer 2
A 38-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 7/13/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the current medical evidence supports the services at issue in this clinical setting. Due to the tomographic nature of the technique, breast tomosynthesis allows radiologists to separate dense glandular elements from underlying mass/architectural distortion resulting in a decrease in callbacks and increase in detection of small cancers. In this case, it was more advantageous for the patient to have her mammogram include breast tomosynthesis than having had it with two-dimensional imaging alone. Therefore, breast tomosynthesis performed on 7/13/15 was likely to have been more effective than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 0 |
A 48-year-old female enrollee has requested reimbursement for CPT codes 64483 and 64484 provided on 10/11/16. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for treatment of the enrollees lumbar radiculitis.
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Upheld
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Medical Necessity
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Summary Reviewer
A 48-year-old female enrollee has requested reimbursement for CPT codes 64483 and 64484 provided on 10/11/16. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for treatment of the enrollees lumbar radiculitis. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the services at issue. There is no documentation of detailed neurologic physical examination, trials of physical therapy, home exercise program, chiropractic care, or other conservative therapies. Per the records, there is a lack of documentation of trial of conservative therapies. There is no documentation of the results of the first or second transforaminal epidural steroid injections, as is the standard of care. There is a lack of support for the services at issue in this clinical setting. All told, CPT codes 64483 and 64484 provided on 10/11/16 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.
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A 36-year-old female enrollee has requested reimbursement for infliximab antibody testing performed on 3/30/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 1
A 36-year-old female enrollee has requested reimbursement for infliximab antibody testing performed on 3/30/15. 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 infliximab antibody testing performed on 3/30/15 was not likely to be more effective for this patient than other available options. Antidrug antibodies develop in a substantial number of patients and may be responsible for acute drug infusion reactions as well as delayed hypersensitivity reactions. In a large percent of patients who develop antibodies, such antibodies may disappear after continued treatment. The reasons for therapeutic failures remain unclear. There are few well controlled clinical trials to confirm that use of the infliximab antibody testing leads to improved patient outcomes or quality of life as opposed to the standard method of treatment (Steenholdt, et al). At this time it has not 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. Given the above, 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.
| 0 |
A 49-year-old female enrollee has requested reimbursement for polymerase
chain reaction (PCR) testing performed on 4/29/19. The Health Insurer has
denied this request and reported that the services at issue were
investigational for the evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 2
A 49-year-old female enrollee has requested reimbursement for polymerase
chain reaction (PCR) testing performed on 4/29/19. The Health Insurer has
denied this request and reported that the services at issue were
investigational for the evaluation of the enrollees medical condition.
The physician reviewer found that PCR testing has been compared to
traditional testing for vaginitis. The literature supports the use of PCR
testing because it results in significantly higher sensitivity and
negative predictive value than clinical diagnosis or clinical testing.
The test may be used to detect more than one cause for vaginitis. PCR
testing is a means of accurate detection that allows for appropriate
treatment. The medical evidence supports the services at issue this
in
patients case. Therefore, PCR testing performed on 4/29/19 was likely to
have been more beneficial than any available standard therapy.
| 0 |
A 37-year-old male enrollee has requested authorization and coverage for the LINX procedure. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD).
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Upheld
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Experimental
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Summary Reviewer 1
A 37-year-old male enrollee has requested authorization and coverage for the LINX procedure. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD). The physician reviewer found that this patients records support a diagnosis of GERD based on pH recording. However, the documentation states that the patient benefited to a significant degree from acid suppression treatment in the past and the failure he reportedly experienced with proton pump inhibitor (PPI) agents did not specify dosage of acid suppressants currently employed. Also, implantation of LINX in this patients setting must be approached with caution given his manometrically documented dysmotility, which is considered a contraindication (Lipham, et al). As such, the requested LINX procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 63-year-old female enrollee has requested reimbursement for ExoSym kinetic orthosis for right knee provided on 9/12/16. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees right knee pain.
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Upheld
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Experimental
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Summary Reviewer 1
A 63-year-old female enrollee has requested reimbursement for ExoSym kinetic orthosis for right knee provided on 9/12/16. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees right knee pain. The physician reviewer found that the ExoSym kinetic orthosis is a customizable energy-storing device that is designed to support and protect an array of lower extremity limb injuries. However, at this time, there is a lack of evidence to support that the published results can be duplicated on a reliable basis. Until quality data becomes available, this orthosis does not have adequate support for use outside of a clinical trial. Accordingly, the ExoSym kinetic orthosis for right knee provided on 9/12/16 was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the device at issue was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 21-year-old female enrollee has requested reimbursement for the outpatient papanicolaou smear testing performed on 7/17/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees abnormal and showed atypical squamous cell of undetermined significance (ASC-US) and high risk human papilloma virus (HPV) test.
on 7/17/15 given the previous abnormal findings on the Pap smear performed in
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Overturned
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Experimental
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Summary Reviewer 2
A 21-year-old female enrollee has requested reimbursement for the outpatient papanicolaou smear testing performed on 7/17/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees abnormal and showed atypical squamous cell of undetermined significance (ASC-US) and high risk human papilloma virus (HPV) test. The physician reviewer found that although the patients cervical cancer screening began earlier than typically recommended due to a sexual assault, the provider in this case is following the established guidelines for follow-up of an ASC-US and HPV positive Pap smear in a 21-year-old. The appropriate follow-up included the repeat Pap smear that was done on 7/17/15 given the previous abnormal findings on the Pap smear performed in 2014. For these reasons, the Pap smear performed on 7/17/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
The parent of a 17-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 has a mid-parental height that is 57, which is between the 10th and 25th percentile.
. The patient had a bone age which was 15 years 6 months in March 2019.
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Upheld
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Medical Necessity
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Summary Reviewer
The parent of a 17-year-old male enrollee has requested 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 fails to demonstrate the medical necessity of the requested medication. Based on the growth chart provided, significant linear deceleration before the age of 14 is not confirmed. A growth velocity of 3.8 cm per year can be normal for a child who is not in puberty. Based on the testosterone level, the patient was probably pre-pubertal. There is a significant family history of delayed puberty in both parents, which also supports the diagnosis of constitutional delay of growth along with a history of multiple bone age studies with 1.5 years bone age delay. This patient has a mid-parental height that is 57, which is between the 10th and 25th percentile. Based on the last bone age and height from March 2019, and using an average bone age prediction, his estimated predicted adult height is 173 cm, which is within normal limits for an adult male. The patient had a bone age which was 15 years 6 months in March 2019. His bone age is likely closer to 16 years of age as of November 2019. This patient is not likely to benefit from growth hormone therapy at this time. Therefore, Humatrope 24 mg cartridge is not medically necessary for the treatment of this patient.
| 1 |
A 38-year-old male enrollee has requested reimbursement and prospective authorization and coverage for acute inpatient psychiatric treatment from 4/17/18 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health condition.
The progress notes from the disputed period indicate that the patient was calm and cooperative. Psychiatric progress notes indicated the patient was adherent with his prescribed medications. These progress notes indicated the patient was open to discussion of his past substance use as well as his current stressors. The patient did not exhibit any suicidal or homicidal ideation or signs of psychosis after the last covered date.
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Upheld
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Medical Necessity
|
Summary Reviewer
A 38-year-old male enrollee has requested reimbursement and prospective authorization and coverage for acute inpatient psychiatric treatment from 4/17/18 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found that the documentation provided does not support the medical necessity of the services at issue in this clinical setting. The progress notes from the disputed period indicate that the patient was calm and cooperative. Psychiatric progress notes indicated the patient was adherent with his prescribed medications. These progress notes indicated the patient was open to discussion of his past substance use as well as his current stressors. The patient did not exhibit any suicidal or homicidal ideation or signs of psychosis after the last covered date. According to the records, it does not appear that the patient needs inpatient psychiatric management at this time. He is not exhibiting dangerous behaviors towards himself or others and is fully cooperative in treatment. Based upon the documentation provided, the patient could receive his mental health treatment in a setting that is less restrictive than an inpatient psychiatric setting, due to his overall stable symptoms. He is not noted to have any severe mood swings or manic symptoms associated with his bipolar disorder. The references cited below indicate that patients with bipolar disorder may be treated outside of a hospital setting with the lack of mania or dangerous behavior, which appears to be the case with the patient and the stay under dispute. There is support, in the medical literature, for outpatient treatment with cognitive behavioral therapy as an effective modality for reduction in reoccurrence of manic symptoms associated with bipolar disorder. The Level of Care Utilization System (LOCUS) for Psychiatric and Addiction Services is an evidence based, objective, instrument in determining necessary level of care for adults, to insure their level of care meets their individual needs, safely and effectively, in the least restrictive setting possible. According to the LOCUS criteria, as of the first disputed date, the patients composite score is 18. A score between 17-19 correlates with a treatment intensity level of three. Level three is described as High Intensity Community Based Services. According to this patients score on the LOCUS criteria, the level of treatment was not and is not medically necessary. The patients risk of harm is scored a 2, mild. While the patient has a history of impulsive behaviors, there is a lack of current suicidal ideation. The patients functional status is scored a 3, (moderate) due to his inability to fulfill responsibilities and obligations. In the area of his medical, addictive and psychiatric co-morbidities, this is scored a 3, (moderate) due to substance issues with a lack of withdrawal symptoms. The patients recovery environment as it pertains to level of stress, is scored a 2, (mild) due to a potential for exposure to substances. The recovery environment as it pertains to level of support is scored a 3, (moderate) due to a stressful relationship with a parent. In the area of treatment and recovery history, this is scored a 3, (moderate). This is due to minimal treatment response in past. His engagement and recovery status is scored a 2, (positive) due to good cooperation in treatment and some current insight into need for treatment. Therefore, according to the LOCUS criteria this patient does not meet acute inpatient psychiatric treatment level of care. As such, acute inpatient psychiatric treatment from 4/17/18 forward was not and is not medically necessary. 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 |
A 47-year-old female enrollee has requested reimbursement for PET scan performed on 8/19/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for evaluation of the enrollees medical condition.
This patient was diagnosed with anal squamous cell carcinoma, and chemoradiation was planned.
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Overturned
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Medical Necessity
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Summary Reviewer
A 47-year-old female enrollee has requested reimbursement for PET scan performed on 8/19/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for evaluation of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the medical necessity of the services at issue. This patient was diagnosed with anal squamous cell carcinoma, and chemoradiation was planned. Studies have shown that PET/CT alters management in a meaningful number of patients, sufficient enough to justify its use as part of staging investigations in locally advanced cases. PET/CT is recommended for both staging and radiotherapy planning in anal cancer, and alters nodal status in enough cases to justify routine use in anal squamous cell carcinoma staging. Guidelines from the National Comprehensive Cancer Network recommend consideration of PET/CT in patients with anal cancer with a biopsy positive for squamous cell carcinoma. In this case, PET/CT was indicated to evaluate for distant (higher-stage) disease before undergoing chemoradiation, given the potential that the imaging would alter her staging or nodal status and therefore change her treatment planning and disease outcome. Therefore, the PET scan performed on 8/19/19 was medically necessary for the evaluation of this patient.
| 1 |
A 55-year-old male enrollee has requested reimbursement for durable medical equipment (special stockings, Sock Aid Nova and stocking donners) provided on 8/2/16. The Health Insurer has denied this request indicating that the equipment at issue was not medically necessary for treatment of the enrollees lymphedema of both lower extremities.
condition. The patient presents with limb threatening lymphedema and venous stasis hypertension. This condition has caused ulcerations and cellulitis in the past.
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Overturned
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Medical Necessity
|
Summary Reviewer
A 55-year-old male enrollee has requested reimbursement for durable medical equipment (special stockings, Sock Aid Nova and stocking donners) provided on 8/2/16. The Health Insurer has denied this request indicating that the equipment at issue was not medically necessary for treatment of the enrollees lymphedema of both lower extremities. The physician reviewer found that the durable medical equipment (special stockings, Sock Aid Nova and stocking donners) provided on 8/2/16 has been established as medically necessary for treatment of the patients medical condition. The patient presents with limb threatening lymphedema and venous stasis hypertension. This condition has caused ulcerations and cellulitis in the past. Prescription strength compression socks are the standard of care for patients with severely swollen lower extremities including, venous stasis hypertension, and lymphedema. These devices allow for mechanical compression of the lower extremity, facilitating movement of the fluid from the lower extremity proximal for distribution and resorption. This will in turn reduce the patients chance of ulceration, possible cellulitis, and possible further other complications. The compression socks along with the device to pull on the compression socks are medically necessary. The stocking donner is important as socks are difficult for people to place on themselves. It is an important part of the compliance of utilizing compression socks. Thus, the equipment at issue was medically necessary for the patients medical condition. Therefore, the equipment at issue was medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned
| 1 |
A 38-year-old female enrollee has requested authorization and coverage for matrix autologous chondrocyte implantation, up to three days in hospital stay and growth of cartilage from her knee. The Health Plan has denied this request indicating that the requested services are considered investigational for treatment of the enrollees osteochondral defect.
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Overturned
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Experimental
|
Summary Reviewer 3
A 38-year-old female enrollee has requested authorization and coverage for matrix autologous chondrocyte implantation, up to three days in hospital stay and growth of cartilage from her knee. The Health Plan has denied this request indicating that the requested services are considered investigational for treatment of the enrollees osteochondral defect. The physician reviewer found the request for matrix autologous chondrocyte implantation, up to three days in hospital stay and growth of cartilage from her knee are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Autologous chondrocyte implantation is a joint sparing/joint salvaging reconstructive procedure. The ankle joint is a complex joint with both dorsiflexion plantar flexion and rotational motion. Attempts to develop total ankle arthroplasty devices has been limited in meeting the design challenges posed by this joint. Kwak and colleagues reported on the long-term outcomes of patients who underwent autologous chondrocyte implantation of the talus after failed marrow stimulation techniques for osteochondral lesions of the talus. The authors concluded that autologous chondrocyte implantation of the talus yielded improvement in clinical parameters and was beneficial with enduring long term results in patients who had failed prior surgeries. Given the support in the peer-reviewed literature, the he requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 60-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis provided on 7/8/16. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 2
A 60-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis provided on 7/8/16. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the digital breast tomosynthesis performed on 7/8/16 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. According to the study by Ciatto and colleagues, the addition of breast tomosynthesis reduces false positives and increases cancer detection when compared to two-dimensional mammography alone. In addition, Detection rates, including those for invasive and in situ cancers, were 6.1 per 1000 examinations for mammography alone and 8.0 per 1000 examinations for mammography plus tomosynthesis (Skaane, et al). Given the support above, the diagnostic procedure at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the diagnostic procedure 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 16-year-old transgender male. The patientas parent has requested authorization and coverage for a mastectomy. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient.
This patient has lived in male role for three years and has been on testosterone for one year, having started testosterone in June 2019.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 16-year-old transgender male. The patientas parent has requested authorization and coverage for a mastectomy. 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 current medical evidence supports the requested services in this clinical setting. The World Professional Association for Transgender Health states, aChest surgery in female-to-male patient could be carried out [in minors]a preferably after ample time living in the desired gender role and after one year of testosterone treatment.a While length of time living stably in gender role and length of time on testosterone are not absolute requirements, they are met by this patient. This patient has lived in male role for three years and has been on testosterone for one year, having started testosterone in June 2019. Chest surgery in transmasculine minors has been demonstrated to be a safe and effective treatment for gender dysphoria. Olson-Kennedy and colleagues stated, aChest dysphoria was high among presurgical transmasculine youth, and surgical interventions positively affected both minors and young adults.a Therefore, the requested mastectomy is medically necessary for the treatment of this patient.
| 1 |
A 55-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 7/14/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic as to her breasts.
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Overturned
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Experimental
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Summary Reviewer 3
A 55-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 7/14/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic as to her breasts. The physician reviewer found that breast tomosynthesis is a technique that was developed several years ago as a problem solving adjunct to routine mammography. Applying the same basic concept as computed tomography 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 dense breasts. In this patients case, her breasts were described as borderline heterogeneously dense. It is specifically those patients who have dense breasts that can benefit most from breast tomosynthesis. The ability to separate out the overlapping structures enables the possibility of demonstrating an otherwise occult tumor. Thus, digital breast tomosynthesis performed on 7/14/16 was likely to have been more efficacious than other methods of evaluating this patient. Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
The patient is a 46-year-old female with a history of left groin pain related to a labral tear and pincer type femoroacetabular impingement. She tried nonoperative treatment including medications, physical therapy, rest, and avoidance of sports but her pain persisted. She underwent an intra-articular injection of local anesthetic into the left hip with good pain relief. The magnetic resonance imaging (MRI) scan showed a complex labral tear of the acetabulum. She underwent arthroscopic management of femoroacetabular impingement with resection of a pincer lesion and debridement of the labrum. The intraoperative findings included mild degenerative changes of the left hip with a small area of fissuring and cartilage softening of the superior weight bearing dome of the acetabulum. There was also extensive degenerative labral tearing from the 10 oclock position to the 2 oclock position of the left hip without any gross labral detachment. The pincer lesion was seen between 11 and 12:00. No cam lesion was identified. The patient has requested for reimbursement for hip surgery performed on 1/31/17. The Health Insurer has denied this request on the basis that the services at issue were investigational for treatment of this patients medical condition.
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Overturned
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Experimental
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Summary Reviewer 3
The patient is a 46-year-old female with a history of left groin pain related to a labral tear and pincer type femoroacetabular impingement. She tried nonoperative treatment including medications, physical therapy, rest, and avoidance of sports but her pain persisted. She underwent an intra-articular injection of local anesthetic into the left hip with good pain relief. The magnetic resonance imaging (MRI) scan showed a complex labral tear of the acetabulum. She underwent arthroscopic management of femoroacetabular impingement with resection of a pincer lesion and debridement of the labrum. The intraoperative findings included mild degenerative changes of the left hip with a small area of fissuring and cartilage softening of the superior weight bearing dome of the acetabulum. There was also extensive degenerative labral tearing from the 10 oclock position to the 2 oclock position of the left hip without any gross labral detachment. The pincer lesion was seen between 11 and 12:00. No cam lesion was identified. The patient has requested for reimbursement for hip surgery performed on 1/31/17. The Health Insurer has denied this request on the basis that the services at issue were investigational for treatment of this patients medical condition. Surgical treatment of symptomatic femoroacetabular impingement aims to improve symptoms and potentially delay hip osteoarthritis and prevent the need for a possible total hip arthroplasty. Hip arthroscopy and open surgical hip dislocations are the two most common surgical approaches used for this condition. The arthroscopic procedure avoids some of the complications of open surgery but both approaches result in over 75% good to excellent results. Femoroacetabular impingement may be of the cam or pincer type, as in this case, or it may be mixed. Surgery is recommended when the degenerative changes are mild or absent, as in this patients case, with documented failure of conservative treatment for over six months. In this case, relief of pain with an intra-articular injection of the hip joint indicated the pain source. The imaging studies further confirmed the pathology. As such, hip surgery was better than any conventional standard treatment. As indicated in the medical literature, the surgery is known to be beneficial and is not investigational. In light of the foregoing, hip surgery performed on 1/31/17 was likely to have been of greater benefit than the standard conventional options available for treatment of the patients medical condition. Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
The parent of a 15-year-old female enrollee has requested reimbursement for residential mental health treatment for children and adolescents provided from 11/27/17 through 1/20/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for the treatment of the enrollees medical condition.
did not have active medical problems and did not have a recent history of substance use.
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Overturned
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Medical Necessity
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Summary Reviewer
The parent of a 15-year-old female enrollee has requested reimbursement for residential mental health treatment for children and adolescents provided from 11/27/17 through 1/20/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that in cases such as this, an evidence-based instrument such as American Academy of Child and Adolescent Psychiatry and the American Association of Community Psychiatrists Child and Adolescent Level of Care Utilization System (CALOCUS) assists in determining necessary level of care for children. With regards to risk of harm, the records support a score of 3 due to her inability to control impulsive aggression towards staff. In terms of her functional status, the records support a score of 4 due to deterioration in interpersonal interactions and serious school disruption. With regards to her comorbidity, the records support a score of 1. The patient did not have active medical problems and did not have a recent history of substance use. In terms of level of stress of the recovery environment, the records support a score of 2. The patient had school disruption and lack of peer support. With regards to level of support of the recovery environment, the records support a score of 2. The patients parents were involved in treatment on a regular basis. In terms of resiliency and treatment history, the records support a score of 5 due to minimal positive treatment response in the past at numerous levels of care. In terms of acceptance and engagement of the patient, the records support a score of 5. The patient had minimal insight into her treatment needs. With regards to acceptance and engagement of the parent, the records support a score of 2. The parents worked actively and constructively with clinicians. Thus, the patient has a composite score of 24, which is consistent with residential level of care. The medical evidence supports the services at issue in this clinical setting. Therefore, residential mental health treatment for children and adolescents provided from 11/27/17 through 1/20/18 was medically necessary for the treatment of this patient.
| 0 |
A 62-year-old male enrollee has requested reimbursement for the mobile heart monitor provided on 8/2/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees palpitations.
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Overturned
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Experimental
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Summary Reviewer 2
A 62-year-old male enrollee has requested reimbursement for the mobile heart monitor provided on 8/2/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees palpitations. The physician reviewer found that he use of different types of ambulatory electrocardiogram monitoring for arrhythmias has evolved over the past 10-15 years (Crawford, et al). Newer patch based systems for two weeks and mobile outpatient telemetry for longer times have developed and are recommended for infrequent symptoms as in this clinical setting. The Heart Rhythm Society noted that the choice of monitor needs to be matched to the individual patients symptom frequency (Steinberg, et al). If symptoms are not present daily, then longer duration monitors are recommended. Given these findings, the mobile heart monitor provided on 8/2/17 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
The patient is a 30-year-old male with a history of gynecomastia. Therefore, the patient has requested authorization and coverage for suction assisted lipectomy, trunk (CPT 15877) and mastectomy, simple complete (CPT 19303). The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient.
. Additional medical information received for review included an email from the provider indicating that a surgical facility charges for liposuction for time and supplies,
. On 5/09/20, the provider noted, aThe bilateral breasts demonstrate Simon Grade IIa gynecomastia. There are tender subareolar masses bilaterally measuring approximately 2 cm x 3 cm x 3 cm.a He also reported that the patient adesires surgical excision of gynecomastia in addition to potential suction lipectomy.a
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is a 30-year-old male with a history of gynecomastia. Therefore, the patient has requested authorization and coverage for suction assisted lipectomy, trunk (CPT 15877) and mastectomy, simple complete (CPT 19303). The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. The physician reviewer found that the case was previously reviewed, and additional documentation was submitted for reconsideration. Additional medical information received for review included an email from the provider indicating that a surgical facility charges for liposuction for time and supplies, and there would still be a charge even if he charged no professional fee. On 5/09/20, the provider noted, aThe bilateral breasts demonstrate Simon Grade IIa gynecomastia. There are tender subareolar masses bilaterally measuring approximately 2 cm x 3 cm x 3 cm.a He also reported that the patient adesires surgical excision of gynecomastia in addition to potential suction lipectomy.a The American Society of Plastic Surgeons reports the following gynecomastia scale adapted from the McKinney and Simon, Hoffman and Kohn scales: grade I a small breast enlargement with localized button of tissue that is concentrated around the areola; grade II - moderate breast enlargement exceeding areola boundaries with edges that are indistinct from the chest; grade III -moderate breast enlargement exceeding areola boundaries with edges that are distinct from the chest with skin redundancy present; grade IV - marked breast enlargement with skin redundancy and feminization of the breast. In this case, photographs demonstrate chest enlargement that significantly exceeds the 2 cm x 3 cm x 3 cm size of the glandular tissue, so that the chest enlargement constitutes mixed gynecomastia, with a mixture of both true glandular gynecomastia and fatty tissue constituting pseudogynecomastia. There is no change in determination that liposuction is an optional surgical technique that can be used during gynecomastia surgery and is not a separate surgical procedure for the patient for treatment of gynecomastia. Liposuction of the chest area well beyond the limited area of the gynecomastia excision can be performed for improved cosmetic appearance, particularly when the gynecomastia is mixed and there is some degree of pseudogynecomastia present. Liposuction for that purpose would be cosmetic and not medically necessary. Thus, suction assisted lipectomy trunk (CPT 15877) is not medically necessary as a separately billed procedure. CPT 19303 is not medically necessary because it applies to a mastectomy in a woman. In sum, suction assisted lipectomy, trunk (CPT 15877) and mastectomy, simple complete (CPT 19303) are not medically necessary for the treatment of this patient. The Health Insurer has approved the appropriate CPT code in this case (CPT code 19300).
| 1 |
A 33-year-old female enrollee has requested reimbursement for the Anser IFX testing performed on 2/18/16. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees small bowel Crohns disease.
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Upheld
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Experimental
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Summary Reviewer 3
A 33-year-old female enrollee has requested reimbursement for the Anser IFX testing performed on 2/18/16. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees small bowel Crohns disease. The physician reviewer found antidrugs antibodies develop in a substantial number of patients and may be responsible for acute drug infusion reactions as well as delayed hypersensitivity reactions. In a large percent of patients who develop antibodies, such antibodies may disappear after continued treatment. The reasons for therapeutic failures remain unclear. There is a lack of well controlled clinical trials to confirm that use of the Anser testing leads to improved patient outcomes or quality of life as opposed to the standard method of treatment (Steenholdt, et al; Nanda, et al). In addition, 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. Moreover, it has not been established 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. In this case, the patient showed good clinical response to Remicade, and no change were made to her Remicade dosing regardless of Anser findings. Thus, the Anser IFX testing performed on 2/18/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 62-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 8/9/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees risk for breast cancer.
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Overturned
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Experimental
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Summary Reviewer 3
A 62-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 8/9/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees risk for breast cancer. The physician reviewer found that there is a lack of peer-reviewed literature that supports the use of three-dimensional breast tomosynthesis compared to currently available techniques, especially in a patient without an increased risk of breast cancer. Although breast tomosynthesis may be a promising technique, its clinical efficacy is yet to be substantiated in peer-reviewed literature. Thus, in this clinical setting, the use of the digital breast tomosynthesis performed on 8/9/16 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 service at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 57-year-old male enrollee has requested reimbursement for conjunctivorhinostomy without tube (CPT 68745) for performed on 10/21/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees blocked tear duct with a possible stone.
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Overturned
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Medical Necessity
|
Summary Reviewer
A 57-year-old male enrollee has requested reimbursement for conjunctivorhinostomy without tube (CPT 68745) for performed on 10/21/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees blocked tear duct with a possible stone. The physician reviewer found the review of the submitted documentation and relevant literature demonstrates the medical necessity for the services at issue. Conjunctival dacryocystorhinostomy is generally the standard approach in treating epiphora caused by lower lacrimal tract obstruction. However, conventional dacryocystorhinostomy works well for the lower drainage system, but not as well for the upper system. In this case, the patient underwent conjunctivorhinostomy for the treatment of upper lacrimal drainage system. Therefore, the conjunctivorhinostomy without tube (CPT 68745) for performed on 10/21/14 was medically necessary in this patients case. For the reasons provided, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 24-year-old male enrollee has requested reimbursement for an implantable interstitial glucose
sensor on 1/7/22. The Health Insurer has denied this request and reported that the device at
issue was investigational for the treatment of the enrollees type 1 diabetes.
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Upheld
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Experimental
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Summary Reviewer 1
A 24-year-old male enrollee has requested reimbursement for an implantable interstitial glucose
sensor on 1/7/22. The Health Insurer has denied this request and reported that the device at
issue was investigational for the treatment of the enrollees type 1 diabetes. The physician
reviewer found that the Eversense is an implantable real time continuous glucose monitoring
(CGM) device which recently became available. The Eversense CGM has an accuracy comparable
to other real-time CGM devices. Unlike other available CGM systems, the Eversense system
requires a finger stick glucose measurement approximately every 12 hours for recalibration in
order to accurately measure the concentration of interstitial tissue fluid glucose. Furthermore, a
trained health care worker needs to surgically remove the Eversense sensor after 90 days in the
United States. While the patients glycemic control has improved with the Eversense CGMS, there
is lack of evidence in current medical literature that an implantable sensor is more beneficial than
standard CGM systems. Therefore, an implantable interstitial glucose sensor on 1/7/22 was not
likely to have been more beneficial for treatment of the patients condition than any available
standard therapy.
| 1 |
A 21-year-old male enrollee has requested reimbursement for corneal collagen crosslinking performed on 9/04/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 3
A 21-year-old male enrollee has requested reimbursement for corneal collagen crosslinking performed on 9/04/18. 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 medical evidence supports the services at issue in this clinical setting. Corneal collagen crosslinking has been U.S. Food and Drug Administration (FDA) approved as a treatment for progressive keratoconus. In this case, based on the patients young age and significant progression in the right eye, he was at risk for further progression of the keratoconus. Thus, corneal collagen crosslinking performed on 9/04/18 was likely to have been superior over other treatment options.
| 0 |
The patient is a 59-year-old male with diabetes, hypertension, and documented obstructive coronary disease, including myocardial infarction, coronary stent placement and coronary artery bypass surgery. The records noted hyperlipidemia, and the patient is intolerant of statin medications and ezetimibe. The patients low-density lipoprotein (LDL) cholesterol is reported at 151 mg/dl. The patient has requested authorization and coverage Repatha SureClick. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient. The Health Insurer noted that the preferred formulary alternative, Praluent, has not been tried or failed. Based on the records provided, the patient has documented obstructive coronary disease and hyperlipidemia with intolerance to multiple statins and ezetimibe but no documented trial of Praluent.
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Upheld
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Medical Necessity
|
Summary Reviewer
The patient is a 59-year-old male with diabetes, hypertension, and documented obstructive coronary disease, including myocardial infarction, coronary stent placement and coronary artery bypass surgery. The records noted hyperlipidemia, and the patient is intolerant of statin medications and ezetimibe. The patients low-density lipoprotein (LDL) cholesterol is reported at 151 mg/dl. The patient has requested authorization and coverage Repatha SureClick. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient. The Health Insurer noted that the preferred formulary alternative, Praluent, has not been tried or failed. Based on the records provided, the patient has documented obstructive coronary disease and hyperlipidemia with intolerance to multiple statins and ezetimibe but no documented trial of Praluent. Praluent (alirocumab) is a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor studied in and approved for patients with heterozygous familial hypercholesterolemia or for patients with documented atherosclerotic heart disease who require additional lowering of LDL cholesterol. This patient fits the latter criteria. In this setting, Praluent has shown to be safe and effective at significantly reducing cholesterol and has been associated with improved cardiac outcomes. There are a lack of trials that adequately compare or conclusively demonstrate an advantage with Repatha SureClick over Praluent. Based on the documentation provided, the preferred formulary alternative Praluent should be effective and sufficient in this circumstance. Thus, Repatha SureClick is not medically necessary for the treatment of this patient. Therefore, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 44-year-old female enrollee has requested reimbursement for an AmniSure test that was performed on 4/7/14. The Health Insurer has denied this request indicating that the test at issue is considered investigational for evaluation of the rupture of the fetal membrane.
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Upheld
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Experimental
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Summary Reviewer 2
A 44-year-old female enrollee has requested reimbursement for an AmniSure test that was performed on 4/7/14. The Health Insurer has denied this request indicating that the test at issue is considered investigational for evaluation of the rupture of the fetal membrane. The physician reviewer found that AmniSure is recognized with generally accepted professional medical standards as being safe and effective. This test is well supported and recommended in difficult diagnostic cases. In this case, the early gestational age of this patient makes accurate diagnosis especially important because this could pose difficult clinical decisions. Accurately diagnosing premature preterm rupture of membranes (PPROM) is crucial to the well-being of the mother and fetus. AmniSure is approved by the Food and Drug Administration (FDA) and is generally recognized as a safe and effective test for the diagnosis of PPROM. In this patients case, the AmniSure test performed on 4/7/14 was likely to be superior for evaluation of this patient than any available standard test for PPROM. Based upon the information set forth above, the test at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 68-year-old male enrollee has requested authorization and coverage for eye medication/eye drops (latanoprost 0.005%, one drop twice daily). The Health Insurer has denied this request indicating that the requested medication dosage is not medically necessary for treatment of the enrollees primary open angle glaucoma.
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Upheld
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Medical Necessity
|
Summary Reviewer
A 68-year-old male enrollee has requested authorization and coverage for eye medication/eye drops (latanoprost 0.005%, one drop twice daily). The Health Insurer has denied this request indicating that the requested medication dosage is not medically necessary for treatment of the enrollees primary open angle glaucoma. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested medication dosage. Latanoprost 0.005% is prescribed as once daily dosing. There is a lack of evidence demonstrating that twice daily dosing is more effective than once daily dosing. The medical evidence does not support the requested medication dosage in this clinical setting. Thus, eye medication/eye drops (latanoprost 0.005%, one drop twice daily) is not medically necessary for the treatment of this patient. Therefore, the requested medication dosage is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 44-year-old male enrollee has requested reimbursement for the substance abuse partial hospitalization program (PHP) services provided from 11/10/15 through 12/3/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees polysubstance abuse.
. His mood was stable and he showed no psychiatric symptoms that required monitoring multiple days per week for multiple hours per day. He was engaged in groups and individual treatment, but did not go to outside meetings and did not have outside support systems in place. He had a history of multiple treatments since 2014, and almost continuous treatment since September 2015.
|
Upheld
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Medical Necessity
|
Summary Reviewer
A 44-year-old male enrollee has requested reimbursement for the substance abuse partial hospitalization program (PHP) services provided from 11/10/15 through 12/3/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees polysubstance abuse. The physician reviewer found the records provided for review indicate that this patient did not experience any withdrawals and did not endorse cravings during the period under dispute. He was not a danger to himself or others. He was medically stable. There were no emotional, behavioral, cognitive, or impulsive symptoms that would warrant treatment at the PHP level of care. His mood was stable and he showed no psychiatric symptoms that required monitoring multiple days per week for multiple hours per day. He was engaged in groups and individual treatment, but did not go to outside meetings and did not have outside support systems in place. He had a history of multiple treatments since 2014, and almost continuous treatment since September 2015. During this course of treatment, the patient did not appear to have progressed significantly enough to warrant PHP level of care. The trauma and resolution work needed could have been safely and adequately managed in the outpatient setting. Further relapse prevention could have taken place on an outpatient basis via 12-step meetings, obtaining of a sponsor, and counseling. He did not require PHP for his psychiatric medication management, as this too could have been accomplished on an outpatient basis. All told, the PHP services provided from 11/10/15 through 12/3/15 were not medically necessary for treatment of this patients behavioral health issues.
| 1 |
A 41-year-old male enrollee has requested reimbursement for transcranial magnetic stimulation (TMS) provided from 10/02/20 through 11/20/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrolleeas medical condition.
in his case, the records document treatment-resistant, recurrent major depressive disorder.
During this episode of depression, the patient again presents with similar Patient
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Overturned
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Experimental
|
Summary Reviewer 1
A 41-year-old male enrollee has requested reimbursement for transcranial magnetic stimulation (TMS) provided from 10/02/20 through 11/20/20. 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 in his case, the records document treatment-resistant, recurrent major depressive disorder. Per the submitted documentation, TMS was an effective treatment for patient in 2019, despite needing maintenance treatments at that time. During this episode of depression, the patient again presents with similar Patient Health Questionnaire 9 (PHQ-9) scores as in early 2019 pre-treatment. The medical evidence supports TMS in this clinical setting. Therefore, TMS provided from 10/02/20 through 11/20/20 was likely to have been more beneficial than other available standard therapy.
| 1 |
A 60-year-old female enrollee has requested reimbursement for genomic analysis performed on 6/15/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ovarian cancer.
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Overturned
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Experimental
|
Summary Reviewer 3
A 60-year-old female enrollee has requested reimbursement for genomic analysis performed on 6/15/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ovarian cancer. The physician reviewer found that there are many agents with activity against recurrent ovarian cancer. Thus, treatment off-label is very common. Recently, it has become important to identify mutations that may be amenable to targeted therapy. Von Hoff and colleagues published a study of 86 patients where the progression-free survival on regimen selected by molecular profiling was compared to progression-free on the last chemotherapy regimen. The regimen selected by molecular profiling offered a 27% survival advantage. The patient is out of standard options and will be offered something off-label. The mutational testing as ordered was medically appropriate. Thus, genomic analysis performed on 6/15/17 was likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 0 |
The patient is a 24-year-old female with diagnoses of borderline personality disorder, major depressive disorder, and generalized anxiety disorder. In April 2019, after an argument with her boyfriend, she became suicidal, with the plan to jump off a freeway overpass.
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Upheld
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Medical Necessity
|
Summary Reviewer
The patient is a 24-year-old female with diagnoses of borderline personality disorder, major depressive disorder, and generalized anxiety disorder. In April 2019, after an argument with her boyfriend, she became suicidal, with the plan to jump off a freeway overpass. The physician reviewer found that the American Psychiatric Association has developed clinical guidelines for the treatment of patients with borderline personality disorder. Per the APA, Clinical experience suggests that most patients with borderline personality disorder will need some form of extended psychotherapy in order to resolve interpersonal problems and attain and maintain lasting improvements in their personality and overall functioning. The APA guidelines note, Two psychotherapeutic
approaches have been shown to have efficacy in randomized controlled trials: psychoanalytic/psychodynamic therapy and dialectical behavior therapy. Per the guidelines, Indications for extended inpatient hospitalization include the following: persistent and severe suicidality, self-destructiveness, or non-adherence to outpatient treatment or partial hospitalization; comorbid refractory axis I disorder (e.g., eating disorder, mood disorder) that presents a potential threat to life; comorbid substance abuse or dependence that is severe and unresponsive to outpatient treatment or partial hospitalization; continued risk of assaultive behavior toward others despite brief hospitalization; and symptoms of sufficient severity to interfere with functioning, work, or family life that are unresponsive to outpatient treatment, partial hospitalization, and brief hospitalization.
The American Association of Community Psychiatrists Level of Care Utilization System for Psychiatric and Addiction Services (LOCUS) is a beneficial tool in determining the appropriate level of care. The (AACP) has developed guidelines for determining the appropriate level of care for patients with mental health symptoms. In this case, with regard to risk of harm, the records support a score of 2. The patient had a low risk of harm, due to transient active suicidality with a plan in the recent past, without current active suicidal or homicidal ideation, plan, or intent, or acute distress. In terms of functional status, the records support a score of 3. The patient had moderate impairment, due to conflict with parents and difficulty maintaining a job or completing college. With regard to comorbidity, the records support a score of 1. The records document the absence of substance abuse or major medical illness. In terms of level of stress of the recovery environment, the records support a score of 3. The documentation noted family discord and inability to fulfill work or academic expectations. The records noted her parents attempts to arrange treatment for the patient. In terms of treatment and resiliency history, the records support a score of 3. The patient had moderate or equivocal response to treatment due to continued symptoms despite past treatment, which was brief, not extended. With regard to engagement and recovery status, the records support a score of 2 due to motivation to continue treatment. In terms of engagement, the records support a score of 2. Therefore, the patient has a total score of 16.
Per the LOCUS guidelines, the appropriate level of care at the time of admission to the residential treatment center was high-intensity community-based services. Additionally, the patients records do not provide clinical documentation of why she was discharged from intensive outpatient program treatment and enrolled in a residential treatment center in June 2019. Therefore, residential treatment provided from 6/19/19 through 7/24/19 was not medically necessary for the treatment of this patient.
| 1 |
patient is a 15-year-old male with a history of chronic migraine. The patient has undergone
evaluation magnetic resonance imaging (MRI) of the head with and without contrast, which was
interpreted as normal. The patient has reportedly experienced excellent results with abortive
therapy in the form of intranasal ketorolac tromethamine solution 15.75 mg/spray. The provider
has recommended continued treatment with ketorolac tromethamine solution spray. The Health
Insurer has denied the requested medication as not medically necessary.
the patients records
document a history of chronic migraines. As reported by the provider, the patient has been treated
with Migrelief, acupuncture, Advil, and nortriptyline without substantial improvement in
symptoms. The patients provider has recommended treatment with ketorolac tromethamine
solution spray.
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Overturned
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Medical Necessity
|
Summary
The patient is a 15-year-old male with a history of chronic migraine. The patient has undergone
evaluation magnetic resonance imaging (MRI) of the head with and without contrast, which was
interpreted as normal. The patient has reportedly experienced excellent results with abortive
therapy in the form of intranasal ketorolac tromethamine solution 15.75 mg/spray. The provider
has recommended continued treatment with ketorolac tromethamine solution spray. 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 patients records
document a history of chronic migraines. As reported by the provider, the patient has been treated
with Migrelief, acupuncture, Advil, and nortriptyline without substantial improvement in
symptoms. The patients provider has recommended treatment with ketorolac tromethamine
solution spray. As noted in the medical literature, ketorolac tromethamine solution spray has been
demonstrated to be effective in the management of patients with chronic migraine who have not
responded to, or are in intolerant to treatment with, other currently available mediations for
migraine. In one study, Rao and colleagues concluded that, This study supports that ketorolac
nasal spray is superior to placebo and that it is non-inferior to sumatriptan nasal spray for the acute
abortive treatment of migraine. Considering this patients documented success with intranasal
abortive therapy with ketorolac tromethamine solution at a dose of 15.75 mg/spray, continued
treatment with this medication is appropriate. Moreover, treatment with ketorolac tromethamine
solution is indicated to help avoid emergency department services should the patients headache
progress to persistent migraine. All told, the requested ketorolac tromethamine solution 15.75
mg/spray is medically necessary for treatment of this patient.
| 1 |
A 46-year-old female enrollee has requested authorization and coverage for Lamictal. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees behavioral health condition.
the patient has been clinically stable for over a year on an
. The patient has been prescribed an appropriate pharmacotherapy
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Overturned
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Medical Necessity
|
Summary Reviewer
A 46-year-old female enrollee has requested authorization and coverage for Lamictal. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found that bipolar disorder represents a severe mental disease that has poor outcomes and an exceedingly elevated suicide rate. Considering the biological nature of this life-long, recurrent illness, pharmacotherapy is a primary treatment modality for bipolar disorder. In this case, the patient has been clinically stable for over a year on an evidence-based bipolar maintenance medication regimen endorsed by current practice guidelines and community standards. The patient has been prescribed an appropriate pharmacotherapy that is consistent with good medical practice and reasonably expected to maintain her clinical stability and prevent an exacerbation of illness. As such, Lamictal 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.
| 1 |
The patient is a 53-year-old female with a history of primary open-angle glaucoma. The provider
states that Vyzulta is the only medication taken by the patient that has been efficacious.
Therefore, the provider has recommended treatment with Vyzulta 0.024% drops. The Health
Insurer has denied the requested treatment as not medically necessary for the treatment of the
patients medical condition.
this case, the patient has a
history of primary open-angle glaucoma.
|
Upheld
|
Medical Necessity
|
Summary Reviewer
The patient is a 53-year-old female with a history of primary open-angle glaucoma. The provider
states that Vyzulta is the only medication taken by the patient that has been efficacious.
Therefore, the provider has recommended treatment with Vyzulta 0.024% drops. The Health
Insurer has denied the requested treatment as not medically necessary for the treatment of the
patients medical condition. The physician reviewer found that according to the American
Academy of Ophthalmology (AAO) guidelines, a prostaglandin such as latanoprost, bimatoprost,
or travoprost is the recommended initial treatment option to lower IOP for patients with primary
open-angle glaucoma. The AAO guidelines state that, If target IOP is not achieved by one
medication, then either switching or adding medications should be considered depending on
whether the individual patient has responded to the first medication. The current medical
literature has compared the efficacy of available prostaglandin analogue eye drops for the
treatment of patients with glaucoma. A study by Cai and colleagues demonstrated that
bimatoprost was more effective in reducing IOP than latanoprost in patients with open-angle
glaucoma. The authors also concluded that there was no clinically significant difference in the
IOP-reducing efficacy of travoprost, latanoprost, and tafluprost. In this case, the patient has a
history of primary open-angle glaucoma. The records provided for review do not demonstrate
that the patient has tried and failed treatment with bimatoprost. In addition, there is a lack of
documentation that the patient has a contraindication to treatment with bimatoprost. Overall,
the medical literature supports that bimatoprost is more efficacious in lowering IOP in patients
with primary open-angle glaucoma than the requested Vyzulta. Therefore, the requested Vyzulta
0.024% drops are not medically necessary for the treatment of this patient.
| 1 |
A 42-year-old female enrollee has requested reimbursement and prospective authorization and coverage for the Optune device with transducer arrays provided from 3/8/17 forward. The Health Insurer has denied this request indicating that the equipment at issue was and is considered investigational for treatment of the enrollees glioblastoma multiforme. The physician reviewer found the patient is a 42-year-old female who has a history of glioblastoma multiforme status post gross total resection, treatment with Temodar concurrent with radiation, followed with temozolomide in combination with tumor treatment fields (TTF) therapy with the Optune device. The patient started Optune therapy on 3/8/17. The patient has requested reimbursement and prospective authorization and coverage for the Optune device with transducer arrays provided from 3/8/17 forward. The Health Insurer has denied this request indicating that the equipment at issue was and is considered investigational. Optune
|
Overturned
|
Experimental
|
Summary Reviewer 1
A 42-year-old female enrollee has requested reimbursement and prospective authorization and coverage for the Optune device with transducer arrays provided from 3/8/17 forward. The Health Insurer has denied this request indicating that the equipment at issue was and is considered investigational for treatment of the enrollees glioblastoma multiforme. The physician reviewer found the patient is a 42-year-old female who has a history of glioblastoma multiforme status post gross total resection, treatment with Temodar concurrent with radiation, followed with temozolomide in combination with tumor treatment fields (TTF) therapy with the Optune device. The patient started Optune therapy on 3/8/17. The patient has requested reimbursement and prospective authorization and coverage for the Optune device with transducer arrays provided from 3/8/17 forward. The Health Insurer has denied this request indicating that the equipment at issue was and is considered investigational. Optune is a wearable and portable, U.S. Food and Drug Administration (FDA) approved device that has been shown in clinical trials to safely deliver continuous therapy to the area of the brain where glioblastoma multiforme tumors are located. Optune is a noninvasive regional therapy that targets dividing cancer cells in the brain and generally does not harm healthy cells. The National Comprehensive Cancer Network (NCCN) guidelines have updated the recommendation for the treatment of glioblastoma multiforme. For the treatment of patients with glioblastoma multiforme with good performance status, a 2A recommendation was added for a treatment option for standard brain radiotherapy, with concurrent temozolomide and adjuvant temozolomide and TTF therapy. Overall, the addition of TTF to maintenance temozolomide chemotherapy can prolong progression free survival. Given these findings, the Optune device with transducer arrays provided from 3/8/17 forward was and 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 equipment at issue was and is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
The parent of a one-year-old male enrollee has requested authorization and coverage for Olumiant
1 mg tablet. The Health Insurer has denied this request and reported that the requested medication
is investigational for the treatment of the enrolleeas medical condition.
. This patient has a mutation in the
SAMHD1 gene, one of the genes that has been noted to be associated with AGS.
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Overturned
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Experimental
|
Summary Reviewer 3
The parent of a one-year-old male enrollee has requested authorization and coverage for Olumiant
1 mg tablet. The Health Insurer has denied this request and reported that the requested medication
is investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that AGS is a rare genetic neurological disease with onset in infancy. This patient has a mutation in the
SAMHD1 gene, one of the genes that has been noted to be associated with AGS. Meesilpavikkai
and colleagues described the successful treatment of chilblains in AGS patients with a SAMHD1
mutation and consequent uparegulation of type I interferon activity. JAK/STAT activation is
present in various autoimmune diseases, and treatment with specific JAK inhibitors in immunemediated
diseases has been increasingly reported. The oral JAK1/2 inhibitor baricitinib (Olumiant)
has been approved for the treatment of active rheumatoid arthritis. Vanderver and colleagues
recently reported that treatment of patients with AGS using baricitinib resulted in decreased skin
manifestations and improved neurological function. An ongoing phase II clinical trial of baricitinib
in AGS is on hold due to the coronavirus pandemic. There is no standard therapy available for
AGS. The syndrome is progressive. There appears to be a narrow window of opportunity for
effective intervention. The requested medication may arrest the progression of ongoing
inflammation and neurological deterioration. Therefore, Olumiant 1 mg tablet is likely to be more
beneficial than other available standard therapy.
| 1 |
patient is a 15-year-old male with a history of short stature and decreased growth velocity.
The provider has recommended treatment with GH therapy. The Health Insurer has denied the
requested treatment as not medically necessary for treatment of the patients medical condition.
This patients records document a history of short stature with decreased growth velocity.
Although the patient has a decreased growth velocity and failed GH
stimulation testing, his predicted adult height is above his mean parental height and is within the
normal
age and gender. Additionally, the patient has a low-normal IGF-1 and a growth
velocity of 4.5 cm per year in the last year.
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Upheld
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Medical Necessity
|
Summary
The patient is a 15-year-old male with a history of short stature and decreased growth velocity.
The provider has recommended treatment with GH therapy. The Health Insurer has denied the
requested treatment as not medically necessary for treatment of the patients medical condition.
This denial is the subject of this appeal and determination. The physician reviewer found that
current medical literature and guidelines from the Pediatric Endocrine Society recommend the use
of GH to normalize adult height and avoid extreme shortness in pediatric patients with GH
deficiency (Grimberg, et al.). In determining whether a patient has GH deficiency, a variety of
factors should be considered, including GH stimulation testing, pituitary hormone testing, IGF-1
testing, growth velocity, bone age, mean parental height, obesity, and height standard deviation.
This patients records document a history of short stature with decreased growth velocity.
However, a diagnosis of GH deficiency for this patient is not supported by the documentation
provided for review. Although the patient has a decreased growth velocity and failed GH
stimulation testing, his predicted adult height is above his mean parental height and is within the
normal range for age and gender. Additionally, the patient has a low-normal IGF-1 and a growth
velocity of 4.5 cm per year in the last year. All told, the requested Genotropin is not medically
necessary for treatment of this patient.
| 1 |
The patient is a 16-month-old male who was born by Cesarean section at 32 weeks 3 days gestation. The patientas parent has requested reimbursement for occupational and speech therapy services provided from 7/24/20 through 8/20/20. 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 was born prematurely, at 32 weeks 3 days gestation. He spent four weeks in the NICU, and required a feeding tube. He has documented developmental delays, including gross motor delays, apraxia, poor emotional regulation, and feeding difficulties.
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Overturned
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Medical Necessity
|
Summary Reviewer
The patient is a 16-month-old male who was born by Cesarean section at 32 weeks 3 days gestation. The patientas parent has requested reimbursement for occupational and speech therapy services provided from 7/24/20 through 8/20/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. The physician reviewer found that the submitted documentation supports the medical necessity of the services at issue. The patient was born prematurely, at 32 weeks 3 days gestation. He spent four weeks in the NICU, and required a feeding tube. He has documented developmental delays, including gross motor delays, apraxia, poor emotional regulation, and feeding difficulties. Spittle and colleagues compared the effectiveness of early developmental intervention program provided post hospital discharge to prevent motor or cognitive impairment in preterm infants versus standard medical follow-up of preterm infants at infancy, preschool age, school age, and adulthood. The authors noted, aInfants born preterm are at increased risk of developing cognitive and motor impairment compared with infants born at term. Early developmental interventions have been provided in the clinical setting with the aim of improving overall functional outcomes for these infants.a Spittle and colleagues noted, aEarly intervention programs for preterm infants have a positive influence on cognitive and motor outcomes during infancy, with cognitive benefits persisting into preschool age.a Woodward and colleagues stated that infants born before 34 weeks of gestation have three times the risk of impairments in multiple developmental domains compared with term infants. Bui reported, aPreterm children should be screened regularly for developmental delay, and parents of preterm infants should be counseled about the options of early intervention programs, and their potential positive impact on development.a In an article describing the importance of physical, occupational and speech therapy for infants born prematurely, Orton and colleagues noted, aThe developmental allied health team, consisting of physical therapy, occupational therapy, and speech pathology, is crucial in early evaluation of gross motor, fine motor, feeding, and language development. Surveillance of neurodevelopment in the first year of life is essential to ensure early detection of specific developmental delays and impairments, and to ensure timely referral for early intervention. Early intervention is not only important in optimizing long-term outcomes for the child, but it also plays an important role in enhancing the parent-child relationship and parental well-being.a The medical evidence supports the services at issue in this clinical setting. Therefore, occupational and speech therapy services provided from 7/24/20 through 8/20/20 were medically necessary for the treatment of this patient.
| 1 |
A 67-year-old male enrollee has requested reimbursement for HCPCS J0775, clostridial collagenase histolyticum injections provided on 11/07/16 and 11/10/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees Peyronies disease.
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Overturned
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Medical Necessity
|
Summary Reviewer
A 67-year-old male enrollee has requested reimbursement for HCPCS J0775, clostridial collagenase histolyticum injections provided on 11/07/16 and 11/10/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees Peyronies disease. The physician reviewer found that Peyronies disease is caused by scar tissue, called plaque, which forms along the length of the penis in the corpora cavernosa. This plaque is not visible, and depending on the severity of the condition, this condition can cause penile curvature with erection. The curvature can make intercourse difficult and/or painful for the patient and his partner. Potential treatments for Peyronies disease include surgery, minimally invasive treatment options, and medications. The results for most previously available medications and minimally invasive therapies have been inconsistent or lacked empirical support for effectiveness. The medical evidence supports the services at issue in this clinical setting. Thus, HCPCS J0775, clostridial collagenase histolyticum injections provided on 11/07/16 and 11/10/16 were 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 54-year-old female enrollee has requested reimbursement for Anser IFX measurement of serum infliximab (IFX) provided on 11/30/15. The Health Plan has denied this request indicating that the service at issue was considered investigational for evaluation the enrollees ulcerative colitis.T
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Upheld
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Experimental
|
Summary Reviewer 1
A 54-year-old female enrollee has requested reimbursement for Anser IFX measurement of serum infliximab (IFX) provided on 11/30/15. The Health Plan has denied this request indicating that the service at issue was considered investigational for evaluation the enrollees ulcerative colitis.The physician reviewer found the Anser IFX measurement of serum infliximab (IFX) provided on 11/30/15 was not likely to be more effective for this patient than other available treatment options. There is a lack of controlled data identifying the optimal drug level. A trial demonstrated this approach had no impact on clinical efficacy compared to empiric dose titration (Steenholdt, et al). It is well known for example that many patients respond very well with low drug levels. Additionally many patients have low levels of antibodies which are transient and insignificant clinically. Therefore, the testing at issue has not been validated using prospectively controlled data. All told, 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 66-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 5/17/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
|
Upheld
|
Experimental
|
Summary Reviewer 1
A 66-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 5/17/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that the prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index has also been thought to add a bit to these statistics. There are two important decision points in the treatment of cutaneous melanoma. The first is
whether or not to do sentinel node; the pathology alone here strongly indicates that the procedure should be done. The second issue is that of whether adjuvant therapy should be given. Coupling the initial pathology, along with the results of the sentinel node, would give enough information to make the decision about adjuvant therapy.
DecisionDx-Melanoma testing is a study of 31 genes in an individualas melanoma cells. It then classifies that particular melanoma based on the five-year risk of metastasis. Gerami reported on 217 cases and found good correlation between DecisionDx-Melanoma testing prediction and prognosis in patients undergoing sentinel node biopsy. However, it is not clear how the DecisionDx-Melanoma testing five-year data compares to the ten-year Balch data. Most importantly, it is not known if it can be used to make therapeutic decisions beyond those that can be made on the pathologic data. Therefore, DecisionDx-Melanoma testing performed on 5/17/19 was not likely to have been more beneficial than other available standard therapy.
| 0 |
patient is a 53-year-old male who presented for a spine surgery evaluation on 6/8/22. The
patient has requested authorization and coverage for inpatient surgery disk replacement,
cervical.
|
Upheld
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Medical Necessity
|
Summary Reviewer
The patient is a 53-year-old male who presented for a spine surgery evaluation on 6/8/22. The
patient has requested authorization and coverage for inpatient surgery disk replacement,
cervical. The physician reviewer found that the submitted documentation does not support the
medical necessity of the requested service. In this case, the records do not demonstrate that the
patient is an appropriate candidate for the proposed cervical arthroplasty as an inpatient surgery
as he not completed nonoperative therapies like physical therapy, injections, or chiropractic care.
Such nonoperative therapies should be attempted before any surgical intervention as they would
affect whether the proposed procedure should be an inpatient or outpatient surgery or whether
the surgical recommendation should be an arthroplasty or fusion. While the patient reports
weakness, which may be a reason to proceed with surgery at some point in the near future, the
patients surgeon does not report that the weakness is profound or worrisome enough to
represent an emergency or to cause permanent morbidity. Rather, the patients surgeon has
recommended that the patient take the time to complete a cardiac evaluation and optimize his
pulmonary function, during which time it would be appropriate for the patient to attempt
nonoperative therapies for his chronic symptoms. Therefore, inpatient surgery disk
replacement, cervical, is not medically necessary for the treatment of this patient.
| 1 |
A 51-year-old female enrollee has requested authorization and coverage for Provigil 200 mg tablets, 60 tablets per 30 days. 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 medical records indicate that the patient has a long history of hypersomnia. She has been evaluated by multiple specialists in order to maximize her medications. This patient has significant functional problems due to her hypersomnia as well as her bipolar disorder, as
|
Overturned
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Medical Necessity
|
Summary Reviewer
A 51-year-old female enrollee has requested authorization and coverage for Provigil 200 mg tablets, 60 tablets per 30 days. 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 medical necessity of the requested medication. The medical records indicate that the patient has a long history of hypersomnia. She has been evaluated by multiple specialists in order to maximize her medications. This patient has significant functional problems due to her hypersomnia as well as her bipolar disorder, as referenced by her use of the antipsychotic medication Clozaril, which is typically reserved for recalcitrant illnesses. Based on the records, the requested medication appears to be working well for her, and discontinuation of the requested medication could have significant adverse results. Therefore, Provigil 200 mg tablets, 60 tablets per 30 days are medically necessary for the treatment of this patient.
| 1 |
patient is a 42-year-old female with a history of treatment resistant, recurrent major
depressive disorder. The patient has requested reimbursement and prospective authorization
and coverage for adult mental health transcranial magnetic stimulation provided from 10/15/21
forward.
. This patient qualifies for the diagnosis
of treatment refractory depression given her two failed antidepressant trials in addition to
psychotherapy. This patient had also tried electroconvulsive therapy. She completed five
treatments but could not tolerate the confusion and headaches. Additionally, she was evaluated
by a psychiatrist who recommended transcranial magnetic stimulation at this point in her
treatment.
|
Overturned
|
Medical Necessity
|
Summary Reviewer
The patient is a 42-year-old female with a history of treatment resistant, recurrent major
depressive disorder. The patient has requested reimbursement and prospective authorization
and coverage for adult mental health transcranial magnetic stimulation provided from 10/15/21
forward. The physician reviewer found that per the medical literature, transcranial magnetic
stimulation is indicated for severe, recurrent major depressive disorder that has not responded
to traditional medication and psychotherapy treatment. This patient qualifies for the diagnosis
of treatment refractory depression given her two failed antidepressant trials in addition to
psychotherapy. This patient had also tried electroconvulsive therapy. She completed five
treatments but could not tolerate the confusion and headaches. Additionally, she was evaluated
by a psychiatrist who recommended transcranial magnetic stimulation at this point in her
treatment. Based on the records, transcranial magnetic stimulation was the appropriate next
step in treatment for this patient. Therefore, adult mental health transcranial magnetic
stimulation provided from 10/15/21 forward was and is medically necessary for the treatment of
this patient.
| 1 |
A 59-year-old female enrollee has requested authorization and coverage for an insulin pump. The Health Insurer has denied this request indicating that the requested device is not medically necessary for treatment of the enrollees diabetes.
While this patient has been able to manage her diabetes via insulin pump therapy, her current pump is no longer functioning. The patient requires a replacement pump in order to optimize her glycemic control.
|
Overturned
|
Medical Necessity
|
Summary Reviewer
A 59-year-old female enrollee has requested authorization and coverage for an insulin pump. The Health Insurer has denied this request indicating that the requested device is not medically necessary for treatment of the enrollees diabetes. The physician reviewer found that insulin pump therapy is a technological advancement that has been developed to help patients manage type 1 diabetes. Insulin pump therapy is associated with psychosocial benefits and improved biomedical outcomes (Reidy, et al). Advantages of insulin pump therapy over multiple daily injections of insulin include better adherence, more accurate dosing, greater lifestyle flexibility, control of the dawn phenomenon without induction of nocturnal hypoglycemia, and the ability to suspend or temporarily reduce basal insulin to compensate for increased physical activity (Millstein, et al). While this patient has been able to manage her diabetes via insulin pump therapy, her current pump is no longer functioning. The patient requires a replacement pump in order to optimize her glycemic control. Accordingly, the requested insulin pump is medically necessary for treatment of this patients type 1 diabetes. Based on the foregoing discussion, the requested device is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 62-year-old male enrollee has requested reimbursement for FoundationOne genomic profile tumor biomarker or gene expression testing performed on 3/01/18. 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.
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Upheld
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Medical Necessity
|
Summary Reviewer
A 62-year-old male enrollee has requested reimbursement for FoundationOne genomic profile tumor biomarker or gene expression testing performed on 3/01/18. 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 atypical meningiomas are not malignant solid tumors. They are associated with a higher risk of recurrence after surgery. Further therapy may include radiation, but not typically systemic therapy. Next generation sequencing, such as with FoundationOne, is used to identify molecular markers for which targeted therapy exists, either in a clinical trial or as standard therapy. This patient would not be considered for systemic therapy based on his diagnosis, and next generation sequencing would be of limited utility in this case. Therefore, FoundationOne genomic profile tumor biomarker or gene expression testing performed on 3/01/18 was not medically necessary for the evaluation of this patient.
| 0 |
A 68-year-old female enrollee has requested authorization and coverage for Repatha 140 mg/ml. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees medical condition.
. Based on the records provided, the patient is a 68-year-old female with known coronary disease, dyslipidemia and documented inability to tolerate several statin medications. Most recently, she is treated with a maximally tolerated low intensity statin, fluvastatin once weekly.
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Overturned
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Medical Necessity
|
Summary Reviewer
A 68-year-old female enrollee has requested authorization and coverage for Repatha 140 mg/ml. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees medical condition. The physician reviewer found that the request for Repatha 140 mg/ml is medically necessary for treatment of the patients medical condition. Based on the records provided, the patient is a 68-year-old female with known coronary disease, dyslipidemia and documented inability to tolerate several statin medications. Most recently, she is treated with a maximally tolerated low intensity statin, fluvastatin once weekly. Her LDL cholesterol on the above maximally tolerated statin is not at goal and there is evidence of progression of coronary disease. Repatha (evolocumab) is a PCSK9 inhibitor approved for patients with heterozygous familial hypercholesterolemia or for patients with documented atherosclerotic heart disease who require additional lowering of LDL cholesterol. The documentation submitted for review shows that the patients LDL is not at goal and that she has tried and did not tolerate several statins including atorvastatin, rosuvastatin and fluvastatin in addition to Zetia in combination with a statin medication. Therefore, the medical necessity for treatment with Repatha 140 mg/ml has been established in this clinical setting. Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 64-year-old male enrollee has requested reimbursement for air ambulance transport on 7/19/14 through 7/20/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition.
the patient was involved in a serious motor vehicle accident on 7/2/14, resulting in multiple life-threatening injuries and requiring air transportation to the nearest hospital for stabilization and intensive medical treatment. The patients condition initially required placement on life support with subsequent sedation and was further complicated by underlying medical problems, such as a history of prior lung cancer.
the hospital nearest to the accident site was able to provide the technical medical skills that the patient required.
|
Upheld
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Medical Necessity
|
Summary Reviewer
A 64-year-old male enrollee has requested reimbursement for air ambulance transport on 7/19/14 through 7/20/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition. The physician reviewer found the review of the submitted evidence demonstrates the patient was involved in a serious motor vehicle accident on 7/2/14, resulting in multiple life-threatening injuries and requiring air transportation to the nearest hospital for stabilization and intensive medical treatment. The patients condition initially required placement on life support with subsequent sedation and was further complicated by underlying medical problems, such as a history of prior lung cancer. Open and active communication among the members of the medical team and the family, and later with the injured person, is of significant importance in this setting in order to consistently match the medical care to the injured persons needs and goals and to maximize subsequent recovery. Further, these extensive injuries typically require prolonged and aggressive medical treatment in order to have the best possible ultimate recovery, function and speech, and ability to think clearly. According to the submitted documentation, the hospital nearest to the accident site was able to provide the technical medical skills that the patient required. However, the significant language barrier prevented the open and active communication that was necessary, and this was likely to interfere with the patients overall medical care and subsequent recovery. Transportation to a facility that had English-speaking medical team members was therefore necessary. However, there were a number of such facilities in Italy and other nearby countries that could meet these criteria. Further, the patients overall condition at the time of the transfer was somewhat tenuous. Shorter transportation time may have placed less physical stress on the body while in this state and would have also returned the patient to a more controlled intensive medical environment faster. For these reasons, air ambulance transportation from Pisa, Italy to the receiving hospital in California was not medically necessary. For the reasons stated above, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 61-year-old male enrollee has requested authorization and coverage for intraoperative EMG monitoring and neuromuscular junction testing during spinal surgery (including anterior cervical procedures). The Health Insurer indicates that the requested services are investigational for the treatment of the enrolleeas medical condition. Therefore, the Health Insurer has denied coverage for the requested services.
a This 61-year-old male was being treated for strain of the lumbar region; sacral back pain; lumbar spondylosis; lumbar radiculopathy; pars defect of lumbar spine; chronic low back pain with bilateral sciatica,
back pain laterally; and spondylolisthesis of the lumbar region. The treatment plan included a single level posterior lumbar fusion at L5-S1.
|
Upheld
|
Experimental
|
Summary Reviewer 2
A 61-year-old male enrollee has requested authorization and coverage for intraoperative EMG monitoring and neuromuscular junction testing during spinal surgery (including anterior cervical procedures). The Health Insurer indicates that the requested services are investigational for the treatment of the enrolleeas medical condition. Therefore, the Health Insurer has denied coverage for the requested services. At issue is whether the requested services are likely to be more beneficial for treatment of the enrollee's condition than any available standard therapy. The physician reviewer found that Charalampidis and colleagues performed a review summarizing relevant studies regarding the utilization of intraoperative neurophysiological monitoring technique in spine surgery. The authors concluded, aAlthough there are no prospective studies validating the efficacy of IONM, there is a growing body of evidence supporting its use during spinal surgery. However, the lack of validated protocols to manage intraoperative alerts highlights a critical knowledge gap. Future investigation should focus on developing treatment methodology, validating practice protocols, and synthesizing clinical guidelines.a This 61-year-old male was being treated for strain of the lumbar region; sacral back pain; lumbar spondylosis; lumbar radiculopathy; pars defect of lumbar spine; chronic low back pain with bilateral sciatica, unspecified back pain laterally; and spondylolisthesis of the lumbar region. The treatment plan included a single level posterior lumbar fusion at L5-S1. Intraoperative EMG monitoring and neuromuscular junction testing during spinal surgery was requested. However, there is limited published, large-scale, long-term peer-reviewed literature that shows the request to be an effective and/or safe treatment for the noted pathology. There is no compelling rationale presented or extenuating circumstances noted to support this request as an exception. Therefore, intraoperative EMG monitoring and neuromuscular junction testing during spinal surgery (including anterior cervical procedures) is not likely to be more beneficial than any available standard therapy.
| 1 |
A 54-year-old female enrollee has requested reimbursement for monitored anesthesia care provided on 10/6/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition.
|
Upheld
|
Medical Necessity
|
Summary Reviewer
A 54-year-old female enrollee has requested reimbursement for monitored anesthesia care provided on 10/6/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition. The physician reviewer found the review of the submitted documentation and relevant literature fails to demonstrate the medical necessity for the services at issue. According to the American Society of Anesthesiologists (ASA), monitored anesthesia care is a planned procedure during which the patient undergoes local anesthesia together with sedation and analgesia. When there is documentation in the patients medical record that specific risk factors or significant medical conditions are present, monitored anesthesia care is clinically indicated. Some factors or significant medical conditions may include patients with potential for difficult intubation and/or ventilation with a mask, at risk for airway obstruction, increased risk for complication due to severe co-morbidity, American Society of Anesthesiologists (ASA) class III physical status or greater, history of myocardial infarction, history of stroke, insulin dependent diabetes, poorly controlled disorders, asthma, psychiatric disorders, dysrhythmias, patients with chronic degenerative neurologic diseases which may cause difficulty swallowing or pose a risk for muscle weakness and respiratory failure, morbid obesity or extremes of age such as older than 70 years or younger than 18 years of age. In this case, the patient had no significant past medical history to indicate that monitored anesthesia care was medically necessary. During a screening colonoscopy for a healthy adult, the standard of practice is for the endoscopy nurse, under the guidance and supervision of the gastroenterologist, to monitor vital signs and pulse oximetry and administer sedation/analgesia, with medications such as midazolam and fentanyl. For the reasons provided, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 0 |
A 66-year-old female enrollee has requested reimbursement for laboratory testing (CPT code 84999) provided on 9/4/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees ulcerative colitis.
|
Upheld
|
Experimental
|
Summary Reviewer 2
A 66-year-old female enrollee has requested reimbursement for laboratory testing (CPT code 84999) provided on 9/4/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees ulcerative colitis. The physician reviewer found that there is currently insufficient medical evidence to support the effectiveness of Anser ADA compared with conventional courses of action in the management ulcerative colitis. The published studies on the use of anti-adalimumab antibodies and serum levels are small, retrospective, and/or observational rather than controlled in nature, preventing firm conclusions about cause and effect (Morita, et al; Roblin, et al). Additionally, the ATLAS study showed that patients with loss of response may actually have high, rather than low, serum levels (Yarur, et al). Moreover, controlled studies are lacking to show that use of the test results in improved long-term health outcomes for patients with ulcerative colitis compared with conventional management. For these reasons, the laboratory testing (CPT code 84999) provided on 9/4/17 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
A 31-year-old female enrollee has requested reimbursement for residential substance abuse treatment services provided from 6/16/14 through 8/16/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees polysubstance abuse.
patients last use of alcohol was 10 days prior to admission and did
detoxification. She had no post-acute withdrawal symptoms, she was not a danger to herself or others, and had no self-harm urges. She was medically stable as her Crohns disease did not require management in the residential setting. Her psychiatric medications were unchanged during the course of her stay. She presented as motivated and insightful, aware that she needed help maintaining sobriety and having the desire to gain insight. She had two prior periods of prolonged abstinence, demonstrating the ability to remain sober in an unstructured environment. She had prior residential treatment and exposure to AA, thereby having a degree knowledge of relapse
|
Upheld
|
Medical Necessity
|
Summary Reviewer
A 31-year-old female enrollee has requested reimbursement for residential substance abuse treatment services provided from 6/16/14 through 8/16/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees polysubstance abuse. The physician reviewer found that The records indicate that this patients last use of alcohol was 10 days prior to admission and did not require detoxification. She had no post-acute withdrawal symptoms, she was not a danger to herself or others, and had no self-harm urges. She was medically stable as her Crohns disease did not require management in the residential setting. Her psychiatric medications were unchanged during the course of her stay. She presented as motivated and insightful, aware that she needed help maintaining sobriety and having the desire to gain insight. She had two prior periods of prolonged abstinence, demonstrating the ability to remain sober in an unstructured environment. She had prior residential treatment and exposure to AA, thereby having a degree knowledge of relapse prevention and sober supports in the community. Moreover, her environment was supportive. The patient could have adequate and effective treatment on an ambulatory level such as partial hospitalization program (PHP) or intensive outpatient program (IOP), and did not require residential level of care. Thus, the residential substance abuse treatment services provided from 6/16/14 through 8/16/14 were not medically necessary for treatment of this patients substance use disorder. 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 66-year-old male enrollee has requested reimbursement for LINX procedure/device performed on 7/27/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee, who has history of belching and heartburn.
|
Upheld
|
Experimental
|
Summary Reviewer 2
A 66-year-old male enrollee has requested reimbursement for LINX procedure/device performed on 7/27/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee, who has history of belching and heartburn. The physician reviewer found For this patient, the services at issue were not superior to the available standard therapy for treatment of his medical condition. There is a lack of randomized controlled trials comparing LINX with Nissen fundoplication or other standard surgical anti-reflux procedures. Per Sheu and colleagues in Curr Opin Gastroenterol, the long-term safety and efficacy of LINX - both alone and in comparison to current GERD therapies - remains to be determined. Loh and colleagues concluded that further studies are required to determine its long term outcomes and its relative efficacy as compared to other established treatments. Adverse events, such as erosion through the esophagus, have been reported since U.S. Food and Drug Administration (FDA) approval (Bauer, et al). Moreover, the American College of Gastroenterology guidelines for the management of reflux disease also state that more evidence is needed before LINX can be recommended (Katz, et al). The available peer-reviewed literature does not definitively support the conclusion that LINX is likely to be more beneficial, in this patients case, than standard treatment of surgical fundoplication. As such, per the available literature and relevant clinical guidelines, LINX procedure/device performed on 7/27/16 was not likely to be more effective than other standard therapy for the treatment of this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
The parent of a four-year-old male enrollee has requested reimbursement for comparative genomic hybridization performed on 1/19/15. The Health Insurer has denied this request indicating that the services at issue were investigational for the evaluation of the enrollees medical condition.
|
Overturned
|
Experimental
|
Summary Reviewer 3
The parent of a four-year-old male enrollee has requested reimbursement for comparative genomic hybridization performed on 1/19/15. The Health Insurer has denied this request indicating that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found there is sufficient support for the services at issue in this patients case. Chromosome microarray testing has been accepted as an appropriate first-line genetic testing for patients with autism spectrum disorders. The testing has the potential to impact treatment, as this may allow the provider to better understand why the patient has certain medical issues. Management also deals with psychological, family, and educational needs, and may vary drastically depending on what is causing a patients issue. Therefore, comparative genomic hybridization performed on 1/19/15 was likely to have been of greater benefit than other modalities. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 0 |
A 35-year-old female enrollee has requested reimbursement for DecisionDx Melanoma testing performed on 1/16/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition.
|
Upheld
|
Medical Necessity
|
Summary Reviewer
A 35-year-old female enrollee has requested reimbursement for DecisionDx Melanoma testing performed on 1/16/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that this patient has an early stage melanoma. The National Comprehensive Cancer Network guidelines state that 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. Newer prognostic molecular techniques should not replace standard staging procedures. In addition, there is a lack of definitive data regarding its use for risk classification in patients with cutaneous melanoma, and this test does not currently have a role in determining which patients are candidates for adjuvant immunotherapy, either as a standard of care or as part of clinical trials. Therefore, the DecisionDx-Melanoma test performed on 1/16/19 was not medically necessary for the evaluation of this patient.
| 0 |
The parent of a four-year-old male enrollee has requested reimbursement for comparative genomic hybridization performed on 1/19/15. The Health Insurer has denied this request indicating that the services at issue were investigational for the evaluation of the enrollees medical condition.
|
Overturned
|
Experimental
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Summary Reviewer 2
The parent of a four-year-old male enrollee has requested reimbursement for comparative genomic hybridization performed on 1/19/15. The Health Insurer has denied this request indicating that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found the current medical evidence supports the services at issue in this clinical setting. The use of chromosomal microarray testing now plays a central role in the evaluation and diagnosis of children with global developmental delay, cognitive delay, and autism spectrum disorders. Shen and colleagues noted that chromosomal microarray analysis had the highest detection rate among clinically available genetic tests for patients with ASD. Interpretation of microarray data is complicated by the presence of both novel and recurrent copy-number variants of unknown significance. The authors reported that chromosomal microarray testing should be considered as part of the initial diagnostic evaluation of patients with ASD. Based on the literature and current standard of practice, comparative genomic hybridization was likely to have been more beneficial than any other available evaluations. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 61-year-old female enrollee has requested reimbursement of collagen crosslinking test (CPT 82523) performed on 9/07/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 1
A 61-year-old female enrollee has requested reimbursement of collagen crosslinking test (CPT 82523) performed on 9/07/18. 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 Osteoporosis is a condition of thinning of the bones which leads to increased risk of fracture. Bone mineral density assessment, via DEXA, is the standard for evaluation and diagnosis of osteoporosis. Since changes in bone mass and density in response to antiresorptive therapy account for only a small portion of the predicted fracture risk reduction, markers of bone turnover may be a useful adjunct in monitoring of osteoporotic patients treated with antiresorptive agents. The medical evidence suggests that biochemical markers may assist in making therapeutic decisions. In general, the higher the bone remodeling and bone loss rates, the greater the concentration of bone biochemical markers in blood or urine. There is sufficient support for the services at issue in this clinical setting. Therefore, collagen crosslinking test (CPT 82523) performed on 9/07/18 was likely to have been superior over other methods of evaluating this patient.
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The parent of a 13-year-old female enrollee has requested reimbursement for transcutaneous electrical modulation pain processing provided from 12/03/18 through 5/14/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition.
regional pain syndrome. She has been treated with physical therapy, epidurals, and other conservative treatment options and pain management techniques, without significant pain relief.
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Overturned
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Experimental
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Summary Reviewer 2
The parent of a 13-year-old female enrollee has requested reimbursement for transcutaneous electrical modulation pain processing provided from 12/03/18 through 5/14/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition. The physician reviewer found that Scrambler Therapy has been shown to be beneficial for complex regional pain syndrome. In this patients case, the records document complex regional pain syndrome. She has been treated with physical therapy, epidurals, and other conservative treatment options and pain management techniques, without significant pain relief. Prior treatment with Scrambler Therapy in 2018 was reportedly beneficial. There are clinical trials and journal articles that show statistically significant benefit utilizing these modalities for complex regional pain syndrome. There is sufficient support for the services at issue in this clinical setting. All told, transcutaneous electrical modulation pain processing provided from 12/03/18 through 5/14/19 was likely to have been more beneficial than any available standard therapy.
| 1 |
INSERTA 56-year-old male enrollee has requested reimbursement for service code 84999, OncotypeDX prostate cancer assay completed on 6/6/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees prostate cancer.
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Overturned
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Experimental
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Summary Reviewer 2
[INSERTA 56-year-old male enrollee has requested reimbursement for service code 84999, OncotypeDX prostate cancer assay completed on 6/6/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees prostate cancer. The physician reviewer found that there are medical studies that support the efficacy of the services at issue in this clinical setting. Molecular assays have been developed in an effort to improve decision making for those patients who have been newly diagnosed. These assays have also been utilized for those patients who are already in treatment but may be considering adjuvant therapy or treatment for recurrence. For patients with clinically localized disease, tumor based molecular assays may also be considered. Retrospective case cohort studies have shown that molecular assays performed on biopsy or prostatectomy specimens provide prognostic information independent of National Comprehensive Cancer Network (NCCN) risk groups. These include, but are not limited to, likelihood of death with conservative management, likelihood of biochemical progression after radical prostatectomy or external beam therapy, and likelihood of developing metastasis after radical prostatectomy or salvage radiotherapy. There are several test available and recommended by the NCCN guidelines, including OncotypeDx prostate. In this patients case, he meets the NCCN criteria. In sum, service code 84999, OncotypeDX prostate cancer assay completed on 6/6/16 was likely to have been more effective than the standard treatment options for the evaluation of this patient. Therefore, for the reasons stated above, the services at issue were likely to have been more beneficial for the evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 91-year-old male enrollee has requested reimbursement for services provided from 3/13/18 through 3/16/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees acute on chronic diastolic heart failure. The physician reviewer found that the records provided for review document that this patient presented with dyspnea on exertion. He was mildly bradycardic, his blood pressure was normal, his respiratory rate was 20, and he was not hypoxic on room air. His anemia and renal function had worsened, with a creatinine almost double his baseline. On 3/15/18, the patient was transfused PRBCs when his hemoglobin dropped below 7. His symptoms appeared to improve with a transfusion of PRBCs and additional diuretics. His renal function returned to baseline with careful diuretic administration. This patient met the criteria for admission and treatment in the telemetry unit given the presence of worsening CHF on imaging, increase of creatinine to twice the level of baseline, and hemoglobin less than 7.
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Overturned
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Medical Necessity
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Summary Reviewer
A 91-year-old male enrollee has requested reimbursement for services provided from 3/13/18 through 3/16/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees acute on chronic diastolic heart failure. The physician reviewer found that the records provided for review document that this patient presented with dyspnea on exertion. He was mildly bradycardic, his blood pressure was normal, his respiratory rate was 20, and he was not hypoxic on room air. His anemia and renal function had worsened, with a creatinine almost double his baseline. On 3/15/18, the patient was transfused PRBCs when his hemoglobin dropped below 7. His symptoms appeared to improve with a transfusion of PRBCs and additional diuretics. His renal function returned to baseline with careful diuretic administration. This patient met the criteria for admission and treatment in the telemetry unit given the presence of worsening CHF on imaging, increase of creatinine to twice the level of baseline, and hemoglobin less than 7. All told, the services provided from 3/13/18 through 3/16/18 were medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 61-year-old female enrollee has requested authorization and coverage for 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.
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Overturned
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Experimental
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Summary Reviewer 2
A 61-year-old female enrollee has requested authorization and coverage for 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 multiple studies indicate that hypoglossal nerve stimulation is a safe and effective treatment option for moderate-severe obstructive sleep apnea patients who have failed medical therapy. The STAR trial showed that upper airway stimulation provides significant improvement in sleep-related quality of life outcome measures. Safety and stable outcome results for the hypoglossal nerve stimulation/Inspire upper airway stimulation system have been demonstrated over 48 months in the peer-reviewed literature. In sum, 64568 and 0466T are likely to be more beneficial than other treatment options.
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patient is a 61-year-old man with low back pain and radiating symptoms. The patient has requested authorization and coverage for spinal surgery. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient.
In this case, the patient has mechanical low back pain with radiating symptoms to the thighs. Although his examination was normal, imaging showed significant spondylolisthesis.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 61-year-old man with low back pain and radiating symptoms. The patient has requested authorization and coverage for spinal surgery. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The physician reviewer found that the submitted documentation supports the medical necessity of the requested services. In this case, the patient has mechanical low back pain with radiating symptoms to the thighs. Although his examination was normal, imaging showed significant spondylolisthesis. The medical literature indicates that patients with mechanical back pain associated with spondylolisthesis have superior outcomes when treated with lumbar fusion. Therefore, the requested spinal surgery is medically necessary for the treatment of this patient.
| 1 |
A 37-year-old female enrollee has requested authorization and coverage for bronchoscopic thermoplasty. The Health Insurer has denied this request indicating that the requested procedure is investigational for treatment of the enrollees persistent asthma.
of the airway. The tissue is heated to 65 degrees Centigrade.
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Upheld
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Experimental
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Summary Reviewer 3
A 37-year-old female enrollee has requested authorization and coverage for bronchoscopic thermoplasty. The Health Insurer has denied this request indicating that the requested procedure is investigational for treatment of the enrollees persistent asthma. The physician reviewer found that Bronchial thermoplasty is a procedure that uses a bronchoscope probe to provide thermal energy to the smooth muscle of the airway. The tissue is heated to 65 degrees Centigrade. There are three bronchoscopic procedures. The first procedure treats the right lower lobe, the second treats the left lower lobe, and the third bronchoscopic procedure is for both upper lobes. The procedures are scheduled three weeks apart. In the medical literature, the therapeutic effect of sham placebo bronchial thermoplasty was similar to bronchial thermoplasty. Castro and colleagues reported that providing thermal energy to the airway had no beneficial effect in their study of 288 patients. This patients provider states the patient has a progressive decrease in the quality of life but there is a lack of documentation that the use bronchial thermoplasty would improve the long-term functional outcome of the patients condition. For these reasons, the requested bronchoscopic thermoplasty is not supported as likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. I have determined that the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Insurers denial should be upheld.
| 1 |
A 57-year-old male requested authorization and coverage for implantation of device (the Coflex device) between the bones of the spine. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollees chronic lower back pain.
tenosis. However, this patient presents with progressively worsening and debilitating low back pain. He has symptoms of neurogenic claudication with associated significant functional limitations.
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Upheld
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Experimental
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Summary Reviewer 2
A 57-year-old male requested authorization and coverage for implantation of device (the Coflex device) between the bones of the spine. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollees chronic lower back pain. The physician reviewer found that the current evidence based medical peer reviewed literature and long term studies support the use of Coflex interlaminar stabilization with decompression as a safe and efficacious alternative to decompression and/or lumbar fusion for the treatment of lumbar spinal stenosis. However, this patient presents with progressively worsening and debilitating low back pain. He has symptoms of neurogenic claudication with associated significant functional limitations. The signs and symptoms reported are consistent with imaging evidence of moderate to severe spinal stenosis at L4/5 with grade 1 anterolisthesis at L4/5. The U.S. Food and Drug Administration contraindications for Coflex include severe facet hypertrophy that requires extensive bone removal which would create instability. Given the presence of severe facet disease, proceeding with the Coflex device is not supported in this patients case. Therefore, implantation of the Coflex device between the bones of the spine is not likely to be more beneficial than other standard methods for the treatment of this patient. Based upon the information set forth above, the requested device is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 38-year-old male enrollee has requested authorization and coverage for neck surgery. The Health Insurer has denied this request indicating that the requested services are investigational for treatment of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 2
A 38-year-old male enrollee has requested authorization and coverage for neck surgery. The Health Insurer has denied this request indicating that the requested services are investigational for treatment of the enrollees medical condition. The physician reviewer found that the requested cervical disc replacement at C5-6 with Mobi-C total disc replacement is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The proposed surgery, especially for single-level cervical is likely to be more beneficial than other treatment options. Moreover, the study by Jackson and colleagues found that treatment with cervical total disc replacement results in a significantly lower rate of subsequent surgical intervention than treatment with anterior cervical discectomy and fusion for both 1 and 2 levels of treatment. For the reasons provided, the requested neck surgery is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 0 |
A 52-year-old male enrollee has requested reimbursement for optical endomicroscopy performed on 5/30/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 3
A 52-year-old male enrollee has requested reimbursement for optical endomicroscopy performed on 5/30/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that the superior effectiveness of the services at issue has not been established. The American Society for Gastrointestinal Endoscopy (ASGE) noted that confocal laser endomicroscopy (CLE) is an emerging technology that has the potential to significantly reduce the number of biopsies in Barretts esophagus and inflammatory bowel disease and reduce the need for removal of non-neoplastic colorectal polyps compared with while light endoscopyLimitations of CLE include the high cost of the equipment and probes, the lack of proven efficacy compared with other widely available advanced imaging techniques, and the need for either intravenous or topical fluorescent contrast agents. Before the technology can be widely accepted, many further studies are needed to determine its clinical efficacy and evaluate its cost-effectiveness and its utilization in both academic and community settings. Intravenous fluorescein used to highlight the vasculature, lamina propria, and intracellular spaces of this tissue being examined does not stain cell nuclei. Nuclear staining can be achieved using topical contrast agents such as acriflavine and cresyl violet, but there is concern over mutagenic potential with the topical agents. In this case, the services at issue were not likely to have been of greater benefit than post-treatment histology and/or follow-up endoscopy to assess for residual dysplastic Barretts tissue. Thus, optical endomicroscopy performed on 5/30/18 was not likely to have been more efficacious than other methods of evaluating this patient.
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The patient is a 49-year-old female with a history of ex pleomorphic adenoma of her right lacrimal gland. The patient has requested authorization and coverage for proton beam therapy. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient.
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is a 49-year-old female with a history of ex pleomorphic adenoma of her right lacrimal gland. The patient has requested authorization and coverage for proton beam therapy. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. The physician reviewer found that per the current peer-reviewed medical literature, there are insufficient high-quality clinical outcomes reported to allow one to make definitive conclusions regarding the relative safety/efficacy of proton beam radiotherapy for management of the patientas head and neck cancer, as compared to standard of care photon-based radiation therapy. In this patientas setting, proton radiation therapy has the ability to reduce the volume of low dose radiation exposure to surrounding normal critical tissues, but it cannot reduce the high dose exposure. Since it is the volume of high dose normal tissue exposure that has traditionally been correlated with radiation-induced morbidity, it remains unclear as to whether the use of proton beam radiation therapy would offer clinically meaningful improvements in outcomes in this patientas case. The treating provider has not supplied a detailed slice-by-slice proton/photon plan comparison in color format to justify the need for proton beam radiation therapy. Typically, a photon-based plan would be associated with a high level of safety/efficacy, and this is supported by high-quality outcomes published in the peer-reviewed medical literature. There are not any extenuating circumstances present in this case that would necessitate the use of proton beam radiation therapy, such as prior receipt of radiation to the same site or genetic/comorbid condition, which increases normal tissue radiosensitivity. The records do not demonstrate that this patient could not be treated safely and effectively with photon-based radiation therapy in the form of intensity modulated radiation therapy. Therefore, proton beam therapy is not medically necessary for the treatment of this patient.
| 1 |
A 68-year-old female enrollee has requested authorization and coverage for Glumetza. The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees type 2 diabetes.
. In this case, the patient had adverse reaction to generic metformin and has been able to tolerate the brand Glumetza.
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Overturned
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Medical Necessity
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Summary Reviewer
A 68-year-old female enrollee has requested authorization and coverage for Glumetza. The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees type 2 diabetes. The physician reviewer found the request for Glumetza is medically necessary for treatment of the patients medical condition. According to the American Diabetes Association guidelines, metformin is first line of therapy in patients with diabetes type 2. It also should be a component of combination therapy as step-up therapy is prescribed. The most common side effect to intermediate release metformin is gastrointestinal (GI) intolerance, therefore several preparations are available (Jabbour and Ziring). In this case, the patient had adverse reaction to generic metformin and has been able to tolerate the brand Glumetza. Glumetza utilizes a modified delivery system, polymer-based, oral drug delivery systems, which allow delivery of metformin hydrochloride to the upper GI tract. There is no generic form of Glumetza. In the aqueous GI environment, the dosage form swells remarkably thereby increasing in size and geometry from where drug is released slowly by a process of diffusion through the gel matrix that is independent of pH. Even though the active component is the same, the delivery systems differ, and therefore it is likely that the patient had an adverse reaction to the generic delivery systems. It is therefore medically necessary that this patient continue taking Glumetza as part of her diabetes management. Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 38-year-old male enrollee has requested authorization and coverage for neck surgery. The Health Insurer has denied this request indicating that the requested services are investigational for treatment of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 3
A 38-year-old male enrollee has requested authorization and coverage for neck surgery. The Health Insurer has denied this request indicating that the requested services are investigational for treatment of the enrollees medical condition. The physician reviewer found that there is insufficient data in the medical literature to adequately assess the performance of total disc replacement. There is a lack of evidence that disc replacement reliably, reproducibly, and over long periods of time fulfills the three primary aims of clinical efficacy, continued motion, and few adjacent segment degenerative problems. Total disc replacement has been associated with a high rate of re-operations, and the potential problems that may occur with longer follow-up have not been fully documented. Additionally, total disc arthroplasty has been associated with substantial morbidity. In this clinical setting, the gold standard procedure would be a single level anterior cervical discectomy and fusion. In sum, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The parent of a four-year-old male enrollee has requested reimbursement for FirstStepDx Plus dated 5/12/16. The Health Plan has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees autism spectrum disorder.
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Overturned
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Experimental
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Summary Reviewer 2
The parent of a four-year-old male enrollee has requested reimbursement for FirstStepDx Plus dated 5/12/16. The Health Plan has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees autism spectrum disorder. The physician reviewer found that chromosomal microarray (CMA) and Fragile X testing are recommended by the American College of Medical Genetics (ACMG) as a first-tier tests for patients with ASD. The yield of CMA in patients with ASD is estimated to be around 10%. CMA has become the standard of care for diagnosis in patients with ASD. Increasing numbers of patients with ASD have been found to have underlying copy number variations. As such, it is possible that some copy number variations have also been associated with specific neuropsychological treatments or medications that have been shown to be more efficacious in patients with ASD due to that underlying cause. Additionally, copy number variations on CMA may inform about possible other complications and medical risks, some of which can be screened for and treated. Fragile X is one of the most common causes of ASD in males. As many as 6% of males with ASD have been found to have Fragile X. Identification of Fragile X will have increasing importance as growing numbers of clinical trials for therapeutic agents begin for Fragile X. All told, the FirstStepDx Plus performed on 5/12/16 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 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.
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Overturned
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Experimental
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Summary Reviewer 2
The parent of a five-year-old male enrollee has requested reimbursement for 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 FirstStep DX Plus testing performed on 10/15/15 was likely to be more effective for this patient with autism than other available treatment options. The study by Henderson and colleagues retrospectively reviewed the medical records of patients who had abnormal chromosomal microarray findings reported per laboratory over a three-year period and quantified the management recommendations made in response to these results. The authors concluded that, These results empirically demonstrate the clinical utility of chromosomal microarray by providing evidence that management was directly affected for the majority of patients in our cohort with abnormal chromosomal microarray findings. Based on the support in the medical literature, the comparative genomic hybridization (CGH) FirstStep DX Plus testing performed on 10/15/15 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.
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The patient is a 75-year-old male initially diagnosed with a prostate cancer in 2022. The patient
has requested authorization of coverage for SBRT. The Health Insurer has denied coverage stating
that SBRT is not medically necessary.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 75-year-old male initially diagnosed with a prostate cancer in 2022. The patient
has requested authorization of coverage for SBRT. The Health Insurer has denied coverage stating
that SBRT is not medically necessary. The physician reviewer found that the management of
metastatic prostate cancer has been focused on systemic therapies such as hormonal therapy,
chemotherapy, or immunotherapy. However, the advent of newer molecular sequencing
techniques and targeted systemic treatments has allowed providers create tailored systemic
therapies to address unique tumors in individual metastatic prostate cancer patients. Patients
who respond well to these targeted systemic therapies demonstrate good disease response, yet
it is still common for certain localized metastatic tumor deposits to continue to grow despite
good overall disease control in the rest of the body. This disease state is referred to as
oligometastatic disease, and this is considered a strong indicator for SBRT. As noted in the
medical literature, SBRT uses special beam technique that allows for delivery of high doses of
radiation while sparing adjacent normal tissue. There is strong evidence showing improved
overall survival and progression-free survival with the addition of SBRT to immunotherapy in an
oligometastatic setting (Pla, et al.; Lin, et al.). In addition, SBRT technique allows for higher doses
to be delivered with greater precision and these higher ablative doses have demonstrated high
local control when treating localized lesions (Navarria, et al.; Ning, et al.). Moreover, standard
radiation therapy has shown some detriment in this setting compared to SBRT, due mainly to a
less effective immune response (Gong, et al.; Khalife, et al.). This patient has a number of
treatment targets located in the thorax and pelvis, so decreased radiation dose is critical in this
setting. In conclusion, the safest way to deliver the necessary radiation dose to this patient is
with SBRT technique. Therefore, the requested per fraction to one or more lesions, including
image guidance, entire course not to exceed five fractions, is medically necessary for treatment
of this patient.
| 1 |
A 31-year-old male enrollee has requested reimbursement for mental health intensive outpatient treatment provided from 8/02/18 through 9/04/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition.
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Upheld
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Medical Necessity
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Summary Reviewer
A 31-year-old male enrollee has requested reimbursement for mental health intensive outpatient treatment provided from 8/02/18 through 9/04/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that in cases such as this, an evidence-based, objective instrument such as the American Association of Community Psychiatrists Level of Care Utilization System (LOCUS) is indispensable in determining necessary and appropriate level of care for adults. In terms of risk of harm, the records support a score of 1 due to a lack of current suicidal ideation or past suicide attempts. With regards to functional status, the records support a score of 1 due to apparent transient impairment in functioning. His activities of daily living were intact. In terms of medical, addictive and psychiatric comorbidity, the records support a score of 2 due to the existence of medical problems which were not immediately threatening and had no impact on the course of his present illness. With regards to level of stress of the recovery environment, the records support a score of 1. His living environment posed no significant threats or risks. In terms of level of support of the recovery environment, the records support a score of 2. Some elements of his support system were willing and able to participate in treatment, if requested, as referenced by including his family in treatment. With regards to treatment and recovery history, the records support a score of 2. The patients substance sobriety has been managed for moderate periods of time. In terms of engagement and recovery status, the records support a score of 2 due to good cooperation in treatment with his current provider. Therefore, the patient has a composite score of 11. This score correlates with clinic-based services without frequent contact. Thus, the patient could have safely been treated in a less restrictive setting. Therefore, mental health intensive outpatient treatment provided from 8/02/18 through 9/04/18 was not medically necessary for the treatment of this patient.
| 0 |
A 44-year-old female enrollee has requested reimbursement for monitored anesthesia care provided on 7/17/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition.
The patient did not present with a significant history that would require monitored
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Upheld
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Medical Necessity
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Summary Reviewer
A 44-year-old female enrollee has requested reimbursement for monitored anesthesia care provided on 7/17/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the services at issue. The patient did not present with a significant history that would require monitored anesthesia care. The standard of care for monitored anesthesia care for a minimally invasive procedure is airway difficulty, large fluid shifts and comorbid conditions that would put the patient at risk during the procedure. There is no documentation of comorbid conditions that would place the patient at risk for complications requiring the need for monitored anesthesia care. All told, monitored anesthesia care provided on 7/17/15 was not medically indicated for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 36-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 11/21/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
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Upheld
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Experimental
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Summary Reviewer 2
A 36-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 11/21/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that there is a lack of support for the services at issue in this clinical setting. Prognostic gene expression profiling (GEP) testing to differentiate melanomas at low versus high risk for metastasis should not replace pathologic staging procedures. Moreover, since there is a low probability of metastasis in stage I melanoma and a higher proportion of false-positive result, GEP testing should not guide clinical decision making in this group. Commercially available GEPs, 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 where these GEP platforms provide clinically actionable prognostic information when used in addition to or in comparison with known cliniopathologic factors or multivariate nomograms that incorporate patient sex, age, tumor location and thickness, ulceration, mitotic rate, lymphovascular invasion, and sentinel lymph node biopsy status. Furthermore, the impact of these tests on treatment outcomes or follow-up schedules has not been established. Various (mostly retrospective) studies of prognostic GEP testing suggest its role as an independent predictor of worse outcome, although not superior to Breslow thickness or sentinel lymph node status. It remains unclear whether this GEP profile is reliably predictive of outcome across the risk spectrum of melanoma. Prospective validation studies are required to more accurately define the clinical utility of molecular testing prior to widespread implementation of GEP for prognostication of cutaneous melanoma, and in particular to determine its role in guiding surveillance imaging, sentinel lymph node biopsy, and adjuvant treatment decisions. Therefore, DecisionDx-Melanoma testing performed on 11/21/19 was not likely to have been more beneficial than other available standard therapy.
| 0 |
A 65-year-old female enrollee has requested authorization and coverage for Venclexta (venetoclax) 100 mg, five tablets daily #150. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees multiple myeloma.
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Upheld
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Experimental
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Summary Reviewer 2
A 65-year-old female enrollee has requested authorization and coverage for Venclexta (venetoclax) 100 mg, five tablets daily #150. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees multiple myeloma. The physician reviewer found that the use of Venclexta in this clinical setting is currently under investigation for use in combination or as a single agent. Moreau and colleagues study, is a phase Ib study and did not include Dara, hence it does not apply in this case. Phase Ib studies do not prove medical necessity nor do they establish the standard of care. Overall, randomized phase II or III clinical trials establish the standard of care. The response shown in this patient was assumed to be related to Venetoclax while this response could be also related to the other drugs used in this combination. In addition, response by itself is not a surrogate for survival benefit. Review of the patients record indicates that this patient has not been treated with all U.S. Food and Drug Administration (FDA) approved agents for the treatment of multiple myeloma such as Pabobinostat. All told, the requested Venclexta (venetoclax) 100 mg, five tablets daily #150 is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested medication is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 56-year-old male enrollee has requested reimbursement for des-gamma-carboxy prothrombin (DCP) testing performed on the enrollee on 5/29/15. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees medical condition.
|
Upheld
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Experimental
|
Summary Reviewer 2
A 56-year-old male enrollee has requested reimbursement for des-gamma-carboxy prothrombin (DCP) testing performed on the enrollee on 5/29/15. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that in patients with cirrhosis of liver, a combination of ultrasound of the liver and alpha-fetoprotein (AFP) are recommended for surveillance for hepatocellular carcinoma. Liver ultrasound is also recommended as the primary surveillance modality for HCC. Other tests that have been used and examined for HCC surveillance include DCP and lectin-bound AFP (AFP-L3%). The evidence is inconclusive about whether these biomarkers perform better than AFP for detecting HCC. AFP was found to be more sensitive than DCP and AFP-L3% for the diagnosis of early stage HCC at a new cutoff of 10.9?ng/ml (Marrero et al). A combination of these markers (AFP, AFP-L3, DCP) only marginally improves the accuracy for early detection of HCC (Carr, et al). Therefore, at this point, the use of DCP has not been established as likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
A 22-year-old male enrollee has requested reimbursement for (81229) cytogenomic constitutional (genome-wide) microarray analysis; interrogation of genomic regions for copy number and single nucleotide polymorphism (SNP) variants for chromosomal abnormalities on 3/16/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees behavioral health condition.
|
Upheld
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Experimental
|
Summary Reviewer 3
A 22-year-old male enrollee has requested reimbursement for (81229) cytogenomic constitutional (genome-wide) microarray analysis; interrogation of genomic regions for copy number and single nucleotide polymorphism (SNP) variants for chromosomal abnormalities on 3/16/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees behavioral health condition. The physician reviewer found that there is a lack of support in the medical literature for the services at issue in this clinical setting. Studies have shown that clinically useful predictors in genetic testing are scarce with results being inconsistent and only marginal clinical association between enzyme system variants and drug metabolism, efficacy, and tolerability. There is a lack of large randomized trials to support its use in this patients case. The existing studies have also indicated that there is no significant correlation between either genotypes or medication serum concentration and response to treatment. Current evidence does not support the use of genotyping when choosing an antidepressant, and even less is understood about its use in the treatment of anxiety disorders. Genetic testing, used in this clinical setting, lacks evidence based research to show its effective use in guiding a clinician towards choosing a medication regimen. As such, (81229) cytogenomic constitutional (genome-wide) microarray analysis; interrogation of genomic regions for copy number and single nucleotide polymorphism variants for chromosomal abnormalities administered on 3/16/16 were not likely to have been more effective than the standard options for evaluating 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.
| 1 |
A 31-year-old female enrollee has requested reimbursement for inpatient mental health services provided from 11/7/17 to 12/6/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees eating disorder and depression.
. The patient presented with significant risk of harm (score 3) with a history of a suicide attempt at age 15 by attempting to overdose on Advil. The patient also has a history of self-cutting from the ages of 14-19 years old. On 11/7/17 and several days prior, the patient had intermittent passive suicidal thoughts. The patient demonstrated moderate functional impairment (score 3) and due to her symptoms, the patient was unable to fulfill her responsibilities in her work. The patient showed significant co-morbidity (score 3) with history of bipolar II, cluster B traits, and bingeing, purging, and restricting behaviors. The patient did not have substance abuse problems. The patients recovery environment is mildly stressful (score 2) as she demonstrated distress while she was traveling in Paris due to isolation. The patients recovery environment was supportive (score 2) and she demonstrated moderate response to prior treatment (score 3). The patient demonstrated positive engagement and recovery (score 2) as she was described as attentive and engaged during treatment. The patient had a positive attitude toward recovery and treatment.
|
Upheld
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Medical Necessity
|
Summary Reviewer
A 31-year-old female enrollee has requested reimbursement for inpatient mental health services provided from 11/7/17 to 12/6/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees eating disorder and depression. The physician reviewer found that applying the level of care utilization system (LOCUS) criteria, the inpatient mental health services provided from 11/7/17 to 12/6/17 were not medically necessary for treatment of this patients behavioral health issues. The patient presented with significant risk of harm (score 3) with a history of a suicide attempt at age 15 by attempting to overdose on Advil. The patient also has a history of self-cutting from the ages of 14-19 years old. On 11/7/17 and several days prior, the patient had intermittent passive suicidal thoughts. The patient demonstrated moderate functional impairment (score 3) and due to her symptoms, the patient was unable to fulfill her responsibilities in her work. The patient showed significant co-morbidity (score 3) with history of bipolar II, cluster B traits, and bingeing, purging, and restricting behaviors. The patient did not have substance abuse problems. The patients recovery environment is mildly stressful (score 2) as she demonstrated distress while she was traveling in Paris due to isolation. The patients recovery environment was supportive (score 2) and she demonstrated moderate response to prior treatment (score 3). The patient demonstrated positive engagement and recovery (score 2) as she was described as attentive and engaged during treatment. The patient had a positive attitude toward recovery and treatment. These findings give the patient a composite score of 18, which is consistent with intensive outpatient program (IOP) level of care. The patient continued to require treatment for her of bipolar II, cluster B traits, and bingeing, purging, and restricting behaviors, but this could have been safely and effectively provided in a less restrictive environment. Therefore, the services at issue were not medically necessary. 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 64-year-old female enrollee has requested reimbursement for gene testing performed on 10/30/17. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
|
Upheld
|
Experimental
|
Summary Reviewer 3
A 64-year-old female enrollee has requested reimbursement for gene testing performed on 10/30/17. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that next-generation sequencing, such as provided by FoundationOne is an appropriate medical diagnostic test for this difficult situation. It is medically appropriate to offer this patient the opportunity to participate in clinical trials. FoundationOne genetic testing is an accepted standard and appropriate diagnostic approach for the identification of clinical trials that would be suitable for this patient, based on tumor mutational analysis. At the time of testing in October 2017, metastatic breast cancer patients had targeted therapy options available through standard of care. Patients with BRCA mutations identified by genomic testing could pursue therapy with olaparib, which was demonstrated to be superior to standard chemotherapy. Additionally, patients with metastatic breast cancer can have tumor mutations for microsatellite instability and DNA mismatch repair, making them eligible for standard treatment with pembrolizumab. The use of FoundationOne testing is an appropriate diagnostic assay for the determination of eligibility for these approved therapies. Use of pathology tests with next-generation sequencing, including FoundationOne genetic testing, was likely to have be more beneficial for this patients medical condition than the choice of available standard therapies based on empirical therapeutic choice processes, as this has the possibility to identify therapies that may be more effective with less toxicity, or to identify potential candidacy for targeted clinical trials that may be provide greater benefit than empiric choice of chemotherapies. Thus, gene testing performed on 10/30/17 was likely to have been of greater benefit than other methods of evaluating this patient.
| 0 |
The patient is a 51-year-old male under evaluation and management for gastroesophageal reflux disease (GERD). The patient has been treated with proton pump inhibitor (PPI) therapy along with over the counter antacids. He mainly complains of heartburn with occasional emesis and dysphagia. In addition, pH testing was borderline positive with acid reflux 5% of the time. Reflux was mostly in the recumbent position and reflux correlated well with symptoms. Esophageal manometry did not demonstrate any significant abnormalities. Upper endoscopy revealed a small hiatal hernia. There was no evidence of Barretts. The patient has requested authorization and coverage for the LINX device. The Health Insurer has denied this request indicating that the requested procedure is considered investigational.
|
Upheld
|
Experimental
|
Summary Reviewer 2
The patient is a 51-year-old male under evaluation and management for gastroesophageal reflux disease (GERD). The patient has been treated with proton pump inhibitor (PPI) therapy along with over the counter antacids. He mainly complains of heartburn with occasional emesis and dysphagia. In addition, pH testing was borderline positive with acid reflux 5% of the time. Reflux was mostly in the recumbent position and reflux correlated well with symptoms. Esophageal manometry did not demonstrate any significant abnormalities. Upper endoscopy revealed a small hiatal hernia. There was no evidence of Barretts. The patient has requested authorization and coverage for the LINX device. The Health Insurer has denied this request indicating that the requested procedure is considered investigational. The US Federal Drug Administration (FDA) approved the LINX for lower esophageal sphincter augmentation for patients with inadequate symptom control with acid suppression therapy, with mild to moderate GERD, and a hiatal hernia less than 3 cm. The device is a ring made up of a series of magnets that have sufficient attraction to increase the lower esophageal sphincter (LES) closure pressure, but allow for food passage with swallowing. In the medical literature, Reynolds and colleagues compared the LINX procedure with laparoscopic fundoplication and found that GERD patients had similar control of reflux symptoms after both LINX and fundoplication. The inabilities to belch and vomit were significantly fewer with LINX, along with a significantly lower incidence of severe gas-bloat symptoms. In addition, Ganz and colleagues reported five-year cohort data establishing the durability of the device. All told, the requested LINX device is supported 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 requested procedure is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
patient is a 20-year-old female with thyroid cancer. She underwent a total thyroidectomy with lymph node dissection on 5/31/19.
The patient was seen by the surgeon on 6/01/19 and was found to have no neurologic issues. She was not given calcium supplementation. There were also no concerns documented in the nursing notes.
|
Overturned
|
Medical Necessity
|
Summary Reviewer
The patient is a 20-year-old female with thyroid cancer. She underwent a total thyroidectomy with lymph node dissection on 5/31/19. The physician reviewer found that the postoperative management and concerns for total thyroidectomy patients, especially those that undergo lymph node dissections, is fairly well understood with algorithms described by major endocrine societies. One of the concerns is hypocalcemia, which can be risk classified based on laboratory values and symptoms. This patients calcium level on postoperative day one was 7.1 mg/dL. This is very low and would qualify as a high risk or a concerning laboratory value. Thus, it was reasonable to continue hospital care, recheck laboratory values and provide calcium supplementation. However, additional submitted records do not substantiate a second night of hospital admission. The patient was seen by the surgeon on 6/01/19 and was found to have no neurologic issues. She was not given calcium supplementation. There were also no concerns documented in the nursing notes. Since the patient was not given calcium, there is no obvious justification for further prolongation of the hospital stay. She could have received pain medication and had follow-up laboratory testing as an outpatient. The initial night of observation and symptom monitoring was medically indicated, but the patient could have been safely discharged on 6/01/19. Therefore, inpatient stay from 5/31/19 through 6/01/19 was medically necessary.
| 1 |
A 48-year-old female enrollee has requested reimbursement for Guardant360 testing performed on 10/15/20. The Health Insurer has denied this request indicating that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
that this patient had a rising CA-19-9 and Guardant360 cell-free DNA testing was ordered.
|
Upheld
|
Experimental
|
Summary Reviewer 1
A 48-year-old female enrollee has requested reimbursement for Guardant360 testing performed on 10/15/20. The Health Insurer has denied this request indicating that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that this patient had a rising CA-19-9 and Guardant360 cell-free DNA testing was ordered. According to the National Comprehensive Cancer Network (NCCN) guidelines on pancreatic cancer, aTesting on tumor tissue is preferred; however, cell-free DNA testing can be considered if tumor tissue testing is not feasible.a This case is clinically complex since biomarkers are indicating cancer recurrence, yet there is no obvious tumor mass to be found on imaging despite a rigorous search. The NCCN guidelines goes on to say, aData are not available to show that earlier treatment of recurrences, following detection by increased tumor marker levels or CT scan, leads to better patient outcomes.a The Guardant360 test is a liquid biopsy that analyzes patient plasma for mutations in a panel of 70 genes. In this case, the Guardant360 test was not done to analyze mutational analysis of an existing recurrence or an existing mass. Instead, it was performed to look for recurrence. This is not an appropriate use of the test. Therefore, Guardant360 testing performed on 10/15/20 was not likely to have been more beneficial than other available standard therapy.
| 1 |
A 56-year-old female enrollee has requested reimbursement for gene test (Breast Cancer Index) performed on 1/6/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee who had a history of breast cancer.
|
Upheld
|
Experimental
|
Summary Reviewer 2
A 56-year-old female enrollee has requested reimbursement for gene test (Breast Cancer Index) performed on 1/6/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee who had a history of breast cancer. The physician reviewer found that the Breast Cancer Index (BCI) is a genome wide microarray analysis developed to identify patients with ER positive breast cancer on endocrine therapy that are at an increased risk of progression. Compared with clinical prognostic factors such as age, tumor size, tumor grade, and lymph node status, the BCI is significantly and independently correlated with outcome. Subsequent studies have validated the BCI as an accurate predictor of endocrine responsiveness among patients with ER-positive breast cancer and of prognosis. In one study, BCI was useful in predicting late recurrence (greater than five years from diagnosis) as compared with other prognostic markers. Given the emerging role of extended adjuvant therapy and the side effects many women experience on them, efforts to identify those patients who are more likely to benefit from this therapy is of great potential value. Therefore, the gene test (Breast Cancer Index) performed on 1/6/17, was more likely to have been of greater benefit than the available standard of care for the evaluation of this patients medical condition. Therefore, for the reasons stated above, the services at issue were likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 37-year-old female enrollee has requested authorization and coverage for bronchoscopic thermoplasty. The Health Insurer has denied this request indicating that the requested procedure is investigational for treatment of the enrollees persistent asthma.
|
Upheld
|
Experimental
|
Summary Reviewer 1
A 37-year-old female enrollee has requested authorization and coverage for bronchoscopic thermoplasty. The Health Insurer has denied this request indicating that the requested procedure is investigational for treatment of the enrollees persistent asthma. The physician reviewer found that based on the documentation provided, there is inadequate evidence for a diagnosis of asthma in this patient. There was no documentation provided to describe the onset of the patients symptoms and pulmonary function testing is normal and does not show evidence of obstruction or bronchodilator response. It would be expected that a patient with severe persistent asthma would demonstrate some abnormality on pulmonary function testing. There is also inadequate data on the patients history of exacerbations which is a prime consideration for bronchoscopic thermoplasty. Consideration should be given to alternate diagnoses such as inducible laryngeal obstruction, excessive dynamic airway collapse and reactive airways dysfunction syndrome for this patients symptoms. In the absence of documented asthma based on physical exam findings, clinical symptoms, exacerbation history, and objective lung function testing, the requested bronchoscopic thermoplasty is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Insurers denial should be upheld.
| 1 |
patient is a 54-year-old female with a history of left hip pain. The patient underwent an MRI
of the left hip on 12/22/22.
, the patients symptoms were present for more than a year. The patient underwent
routine radiographs.
|
Overturned
|
Medical Necessity
|
Summary
The patient is a 54-year-old female with a history of left hip pain. The patient underwent an MRI
of the left hip on 12/22/22. The physician reviewer found that at issue is whether the left hip MRI
provided on 12/12/22 was medically necessary for this patient. Guidelines from the American
College of Radiology (ACR) have established that MRI is highly sensitive and specific for detecting
many abnormalities involving the surrounding soft tissues and should, in general, be the first
imaging technique used after radiographs. The guidelines add that, MRI is useful for examining
surrounding soft tissue entities such as iliopsoas or subiliacus bursitis, athletic pubalgia,
trochanteric bursitis, abductor tendinosis or tears, calcific tendonitis, and hamstring injuries and
for sources of referred pain from spine or knee. Other causes of a chronically painful hip for which
MRI has been used with considerable success include acute and chronic soft tissue injuries. In
this case, the patients symptoms were present for more than a year. The patient underwent
routine radiographs. It is unlikely that any imaging modality other than an MRI would provide the
important information to evaluate the patient. Therefore, the left hip MRI provided on 12/12/22
was medically necessary for this patient.
| 1 |
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