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A 32-year-old female enrollee has requested reimbursement for polymerase chain reaction testing performed on 4/12/21. 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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Overturned
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Experimental
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Summary Reviewer 2
A 32-year-old female enrollee has requested reimbursement for polymerase chain reaction testing performed on 4/12/21. 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 polymerase chain reaction testing is likely to have been more beneficial than any available standard therapy in this case. For a patient who presents with symptoms of abnormal vaginal discharge, an examination of the vaginal discharge, including microscopic evidence of infection, can lead to a definitive diagnosis. In the case, where microscopy is not available, commercial diagnostic testing methods, including polymerase chain reaction, are used for confirming the clinical suspicion of bacterial vaginosis, vaginal candidiasis, or trichomonas vaginitis. Furthermore, polymerase chain reaction testing can be utilized for detecting both gonorrhea and chlamydia. Microscopy is no longer widely available in clinic settings, and practices are now relying on this testing to diagnose and treat vaginitis. Current studies reported sensitivities and specificities of over 96 percent for the detection of Neisseria gonorrhoeae and Chlamydia trachomatis. Therefore, polymerase chain reaction testing performed on 4/12/21 was likely to have been more beneficial for evaluation of the patientas condition than any available standard therapy.
| 0 |
A 19-year-old male enrollee has requested authorization and coverage for lumbar disc
arthroplasty and two inpatient days. 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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Upheld
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Experimental
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Summary Reviewer 1
A 19-year-old male enrollee has requested authorization and coverage for lumbar disc
arthroplasty and two inpatient days. 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 lumbar disc arthroplasty (LDA) remains a
controversial surgical strategy for the treatment of low back pain related to isolated
degenerative disc disease, mostly based on its comparison to what is perceived as the gold
standard surgical procedure, lumbar spinal fusion. When attempting to discern the efficacy and
safety of lumbar disc arthroplasty, it is important to note that there are meaningful data both
favorable and unfavorable regarding the technique, in particular when comparing it to lumbar
fusion surgery. Guntin and colleagues systematically reviewed 57 seminal publications and
noted that only 39 of them reported favorable results for lumbar disc arthroplasty in this
context. The main thrust of their review, however, was to analyze how conflicts of interest
influence the outcomes of studies in the lumbar disc arthroplasty literature. They noted that
manuscripts where conflicts of interest were present were significantly more likely to report
favorable outcomes of lumbar disc arthroplasty versus non-conflicted studies. A number of
other systematic reviews and meta-analyses have failed to demonstrate superiority of lumbar
disc arthroplasty to fusion but found it equivalent. The standard therapies for the treatment of
the patient include the following: medications, physical therapy (including traction), spinal
injections, bracing, alternative therapies (i.e. acupuncture) and lifestyle modifications. The gold
standard surgical treatment is a fusion surgery. This patient has already attempted and failed
meaningful non-surgical strategies. On the basis that the abundance of accumulating evidence
supports at best equivalence of lumbar disc arthroplasty to fusion surgery in this setting, the
superior efficacy of the requested services has not been demonstrated. The requested services
are not likely to be more beneficial than other surgical strategies, like decompression and
fusion. Therefore, the requested lumbar disc arthroplasty and two inpatient days are not likely
to be more beneficial than any available standard therapy.
| 1 |
A 52-year-old female enrollee has requested reimbursement for bilateral reduction mastopexies provided on 3/21/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees bilateral macromastia with ptosis.
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Upheld
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Medical Necessity
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Summary Reviewer
A 52-year-old female enrollee has requested reimbursement for bilateral reduction mastopexies provided on 3/21/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees bilateral macromastia with ptosis. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. The records do not document that the patient had typical signs and symptoms associated with functional impairment related to macromastia. There was no medical description of pain, shoulder grooving, chronic rashes or other signs and symptoms to support that the planned procedure was reconstructive surgery. Thus, bilateral reduction mastopexies provided on 3/21/17 was not medically necessary for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
The patient is a 36-year-old female with diagnoses of opioid use disorder, amphetamine use disorder, unspecified anxiety disorder, and unspecified depressive disorder. Prior treatment included admissions in 2010, intensive outpatient program (IOP) and sober living in 2011, as well as detoxification and admission in 2016, and hypnotherapy. She tried to self-detoxification and would relapse once a month, then in the year prior to this admission was unable to decrease or stop using. She was admitted on 7/22/16 and endorsed using intravenous (IV) heroin 1-2 gm a day, smoking methamphetamine 1 gram a day, and cannabis daily. Her longest period of sobriety was four months in 2012. The patient used alcohol in the past but not during the prior five years. She has a history of being tried on Subutex in May 2016, however she stopped and then relapsed. She attests to having prior delirium tremens and blackouts, but no seizures. She indicated that her father has a history of schizophrenia and her mother has borderline personality disorder. She has a history of anxiety and depression but was not admitted on any psychotropic medications. She attended individual, group, and family therapies, as well as biofeedback. On 8/10/16, she had anxiety and worked on feelings of guilt and dysfunctional beliefs. She was not a self-harm risk and her mood was
group work. The patient has requested reimbursement for residential treatment center
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is a 36-year-old female with diagnoses of opioid use disorder, amphetamine use disorder, unspecified anxiety disorder, and unspecified depressive disorder. Prior treatment included admissions in 2010, intensive outpatient program (IOP) and sober living in 2011, as well as detoxification and admission in 2016, and hypnotherapy. She tried to self-detoxification and would relapse once a month, then in the year prior to this admission was unable to decrease or stop using. She was admitted on 7/22/16 and endorsed using intravenous (IV) heroin 1-2 gm a day, smoking methamphetamine 1 gram a day, and cannabis daily. Her longest period of sobriety was four months in 2012. The patient used alcohol in the past but not during the prior five years. She has a history of being tried on Subutex in May 2016, however she stopped and then relapsed. She attests to having prior delirium tremens and blackouts, but no seizures. She indicated that her father has a history of schizophrenia and her mother has borderline personality disorder. She has a history of anxiety and depression but was not admitted on any psychotropic medications. She attended individual, group, and family therapies, as well as biofeedback. On 8/10/16, she had anxiety and worked on feelings of guilt and dysfunctional beliefs. She was not a self-harm risk and her mood was appropriate. On this date, the patients goals were to become familiar with three dysfunctional life patterns and utilize this information in her individual sessions and group work. The patient has requested reimbursement for residential treatment center (RTC) level of care services provided from 8/11/16 through 9/4/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary. Consistent with the current American Society of Addiction Medicine (ASAM) guidelines, the RTC level of care services provided from 8/11/16 through 9/4/16 were not medically necessary for treatment of this patients behavioral health issues. On 8/10/16, the progress records do not show any signs or symptoms of post-acute withdrawal. There was no evidence to suggest that she was a danger to herself or others. She was not gravely disabled. There were no emotional, behavioral, or cognitive issues impeding stepping the patient down to a lower level of care. She was not manic, psychotic, delusional, or impulsive to the point where she required the residential setting. Progress notes focused on the patients dysfunctional thoughts and beliefs, and there were no 12 step meetings documented. In addition, it is unclear if she underwent any type of detoxification protocol or was treated with any medications. Ongoing treatment of the patients anxiety and dysfunctional thoughts did not require the residential setting. These issues do not require 24-hour monitoring, and could have been rendered in an ambulatory setting. 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 |
The parent of a 16-year-old male enrollee has requested authorization and coverage for reconstructive repair of pectus excavatum or carinatum with one overnight hospital stay. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees medical condition.
The records document pectus excavatum with a Haller index of 4.0. This patient has a chest wall deformity, and the requested surgical repair is medically
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Overturned
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Medical Necessity
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Summary Reviewer
The parent of a 16-year-old male enrollee has requested authorization and coverage for reconstructive repair of pectus excavatum or carinatum with one overnight hospital stay. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees medical condition. The physician reviewer found there is sufficient support for the requested services in this patients case. The records document pectus excavatum with a Haller index of 4.0. This patient has a chest wall deformity, and the requested surgical repair is medically appropriate. The records support the requested correction of a congenital abnormality of the chest wall to normalize a deformity. Pectus excavatum is a significant truncal physical variation from normal. In sum, the requested reconstructive repair of pectus excavatum or carinatum with one overnight hospital stay is medically indicated for the treatment of this patient. Therefore, the requested services are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 50-year-old female enrollee has requested reimbursement for CPT code 81479 (unlisted molecular pathology, Cxbladder) performed on 12/19/18. 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 2
A 50-year-old female enrollee has requested reimbursement for CPT code 81479 (unlisted molecular pathology, Cxbladder) performed on 12/19/18. 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 bladder cancer molecular testing remains an adjunct to standard evaluation. Standard evaluation includes cystoscopy and urine cytology. Urinary biomarkers, including Cxbladder urine testing, may be useful in increasing the sensitivity of diagnosis. However, urine messenger RNA testing to detect gene expression for bladder cancer cells remains investigational at this time. Superiority of this test compared to conventional evaluation of hematuria remains to be elucidated with further studies. Recommended evaluation continues to be contrast enhanced imaging of the urinary tract and cystoscopy. In sum, CPT code 81479 (unlisted molecular pathology, Cxbladder) performed on 12/19/18 was not likely to have been more beneficial than other methods of evaluating this patient.
| 0 |
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.
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Overturned
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Experimental
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Summary Reviewer 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. The physician reviewer found that the Pap smear performed on 7/17/15 was indicated and consistent with current guidelines for the management of an ASC-US and positive HPV Pap smear. Since the Pap smear in 2014 was abnormal, these findings required specific management planning. The ASC-US Pap smear posed a risk of representing underlying disease and needs to be clinically managed the same as a patient is in the 21-24 age category. The guidelines for management of an ASC-US and HPV positive Pap smear is to either proceed with colposcopy evaluation or to repeat the Pap smear in one year. The Pap smear done in 2015 was done as the recommended repeat study. Thus, the Pap smear performed on 7/17/15 was likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 64-year-old female enrollee has requested reimbursement for genetic testing performed on 11/30/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who was diagnosed with breast cancer.
For this patient, the report indicated a 20% risk of a recurrent event when the biopsy was examined. The surgical specimen analysis was associated with a 34% risk of recurrence of invasive disease.
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Overturned
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Experimental
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Summary Reviewer 2
A 64-year-old female enrollee has requested reimbursement for genetic testing performed on 11/30/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who was diagnosed with breast cancer. The physician reviewer found OncotypeDX breast cancer assay uses reverse transcriptions polymerase chain reaction to assess the genomic profile by analyzing the tumor tissue with a panel of 21 genes. There is data which supports use of this assay for patients with DCIS or early stage invasive ductal adenocarcinoma to help direct care. For this patient, the report indicated a 20% risk of a recurrent event when the biopsy was examined. The surgical specimen analysis was associated with a 34% risk of recurrence of invasive disease. Studies assessing the benefit of the OncotypeDX recurrence score assay provides a prediction regarding locoregional and distant recurrence for postmenopausal women treated with tamoxifen or those treated with an aromatase inhibitor. There have also been studies that demonstrate its ability to predict response to adjuvant therapy. High scores indicated benefit from chemotherapy and low scores, regardless of lymph node involvement, did not appear to benefit. Recent data has validated the use of OncotypeDX in DCIS. It analyzes 12 genes instead of 21. The use of OncotypeDX has been validated in multiple studies but is not included in current treatment guidelines. However, in this patients clinical case, the use of OncotypeDX at two different time points helped guide the surgeon and the patient. Without the genetic testing, this patient would not have undergone mastectomy and the invasive component may not have been detected. Since current guidelines give the option of chemotherapy and Herceptin (category 2B) then the OncotypeDX performed on 11/30/16 helped direct this patients postoperative treatment plan. All told, the genetic testing performed on 11/30/16 was likely to have been more effective than the standard options for 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 64-year-old female has requested reimbursement for FoundationOne testing performed on 1/13/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.T
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Upheld
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Experimental
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Summary Reviewer 1
A 64-year-old female has requested reimbursement for FoundationOne testing performed on 1/13/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.The physician reviewer found there is a lack of support for the services at issue in this clinical setting. Molecular profiling of a patients cancer cells, as is done with FoundationOne testing, is an assay of genomic or molecular abnormalities. The goal would be to identify a target at which a specific treatment could then be offered. At this time, there is a lack of convincing evidence that the assay adds to decision making ability in a way to significantly improve patient outcome. There are a variety of non-randomized studies exploring the value of molecular profiling that have as yet not been convincing. A recent randomized study by Le Tourneau and colleagues did not demonstrate significant clinical benefit from choosing therapy based on molecular targets. Therefore, FoundationOne testing performed on 1/13/16 was not likely to have been more efficacious than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
A 51-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing
performed on 1/18/21. The Health Insurer has denied this request and reported that the
services at issue were investigational for the evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 2
A 51-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing
performed on 1/18/21. The Health Insurer has denied this request and reported that the
services at issue were investigational for the evaluation of the enrollees medical condition. The
physician reviewer found that the staging and prognosis of cutaneous melanoma is classically
determined by applying the system spelled out by Balch. Mitotic index may add to these
statistics. DecisionDx-Melanoma testing is an assay of 31 genes in an individuals melanoma
cells. It then places that melanoma into either Class 1 or Class 2. It is not clear how the five-year
DecisionDx-Melanoma data compares to the ten-year Balch data. Particularly in this case, it is
not clear how the DecisionDx-Melanoma classification would have added clinical information to guide further surveillance and treatment. There is a lack of data indicating whether the
DecisionDx-Melanoma data can be used to make clinical decisions. Therefore, DecisionDx-
Melanoma testing performed on 1/18/21 was not likely to have been more beneficial than
other available methods of evaluating this patient.
| 0 |
The patient is a 39-year-old female who has a history of migraines and palpitations. The patient has requested reimbursement for laboratory testing performed on 11/12/19 and 1/17/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of this patient.
this patient had a persistent thrombocytosis with a platelet count greater than 450 on three separate occasions.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 39-year-old female who has a history of migraines and palpitations. The patient has requested reimbursement for laboratory testing performed on 11/12/19 and 1/17/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of this patient. The physician reviewer found that this patient had a persistent thrombocytosis with a platelet count greater than 450 on three separate occasions. Iron studies are reported to be normal. It could not be determined from peripheral studies if the thrombocytosis was reactive or part of a myeloproliferative neoplasm or other neoplastic process. Molecular studies on peripheral blood were negative. Performing a bone marrow biopsy in this situation is a standard of care. Given the differential diagnosis, the services at issue are standard. The medical records support the services at issue in this clinical setting. Therefore, laboratory testing performed on 11/12/19 and 1/17/20 was medically necessary for the evaluation of this patient.
| 1 |
A 34-year-old male has requested reimbursement for polymerase chain reaction (PCR) testing performed on 8/03/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
In this case, the patient presented with a recent pharyngitis and rash after treatment with an antibiotic. At the time of presentation, the patient noted improved symptoms with treatment of the antibiotic, and there was no fever or enlarged lymph nodes on examination. The concern was for EBV infection causing mononucleosis.
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Upheld
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Experimental
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Summary Reviewer 2
A 34-year-old male has requested reimbursement for polymerase chain reaction (PCR) testing performed on 8/03/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that the EBV infection can be suspected with an appropriate clinical presentation of sore throat, fever, and malaise with enlarged lymph nodes on examination. The recommended laboratory testing for a case of EBV infection causing mononucleosis is a complete blood count and liver enzymes and heterophile antibodies. In this case, the patient presented with a recent pharyngitis and rash after treatment with an antibiotic. At the time of presentation, the patient noted improved symptoms with treatment of the antibiotic, and there was no fever or enlarged lymph nodes on examination. The concern was for EBV infection causing mononucleosis. The testing with a complete blood count was unremarkable, and the appropriate test for EBV infection would have been heterophile antibody testing. The requested PCR would not be more beneficial in this case than the recommended testing, heterophile antibody testing. In sum, PCR testing performed on 8/03/17 was not likely to have been more effective than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 65-year-old male enrollee has requested reimbursement for genetic testing performed on 4/16/15. The Health Insurer has denied this request indicating that the testing at issue was 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 3
A 65-year-old male enrollee has requested reimbursement for genetic testing performed on 4/16/15. The Health Insurer has denied this request indicating that the testing at issue was investigational for the evaluation of the enrollees medical condition. The physician reviewer found that HLA-B5701 genetic testing is the standard of care in the treatment of HIV patients. U.S. Department of Health and Human Services (HHS) guidelines recommend HLA-B5701 genetic testing when initiating antiretroviral therapy or when considering abacavir. The test can take up to 2 to 3 weeks to obtain results so providers generally order the testing ahead of time to prevent a later delay in treatment. In addition, abacavir is a preferred regimen and is likely to be in the next selection of treatment options for this patient. In sum, HLA-B5701 genetic testing was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 0 |
A 40-year-old female enrollee has requested authorization and coverage for thermal destruction
of intraosseous basivertebral nerve. The Health Insurer has denied this request indicating that
the requested services are considered investigational for treatment of the insureds spondylosis
without myelopathy or radiculopathy, lumbar region.
the patient has been diagnosed with spondylosis without myelopathy
or radiculopathy of the lumbar region,
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Overturned
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Experimental
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Summary Reviewer 1
A 40-year-old female enrollee has requested authorization and coverage for thermal destruction
of intraosseous basivertebral nerve. The Health Insurer has denied this request indicating that
the requested services are considered investigational for treatment of the insureds spondylosis
without myelopathy or radiculopathy, lumbar region. The physician reviewer found that with
regard to the request for thermal destruction of intraosseous basivertebral nerve, there is
medical evidence supporting this treatment modality for the treatment of chronic low back pain.
Per Fischgrund and colleagues, patients treated with radiofrequency ablation of the
basivertebral nerve for chronic low back pain exhibited sustained clinical benefits in Oswestry
Disability Index (ODI) and Visual Analog Scale (VAS) and maintained high responder rates at two
years following treatment. The authors concluded that, Basivertebral nerve ablation appears
to be a durable, minimally invasive treatment for the relief of chronic low back pain. Similarly,
Khalil and colleagues found that, minimally invasive radiofrequency ablation of the basivertebral
nerve led to significant improvement of pain and function at 3-months in patients with chronic
vertebrogenic related low back pain. Furthermore, Sayed and colleagues reported that, Current
evidence supports long-term improvement in pain and function in properly selected patients for
basivertebral nerve ablation. Within the records available for review, there is documentation of
chronic low back pain and the patient has been diagnosed with spondylosis without myelopathy
or radiculopathy of the lumbar region, and intervertebral disc degeneration of the lumbar region.
The treating provider has recommended thermal destruction of intraosseous basivertebral
nerve. The medical records indicate that the patient has exhausted conservative treatment
including physical therapy, medication management, transforaminal epidural steroid injections,
and chiropractic care. Therefore, the requested thermal destruction of intraosseous
basivertebral nerve is likely to be more beneficial for treatment of the patients medical condition
than any available standard therapy.
| 1 |
The parent of a 12-year-old male enrollee has requested authorization and coverage for real-time intra-fraction target tracking for planned proton beam radiotherapy. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees craniopharyngioma status post resection.
presents with craniopharyngioma and is planned for radiation treatment.
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Overturned
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Experimental
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Summary Reviewer 1
The parent of a 12-year-old male enrollee has requested authorization and coverage for real-time intra-fraction target tracking for planned proton beam radiotherapy. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees craniopharyngioma status post resection. The physician reviewer found that this patient presents with craniopharyngioma and is planned for radiation treatment. As the disease is close to optic pathway, any excessive dose to optic pathway will likely cause serious late complications. Thus, the treating provider is using real-time intra-fraction tracking as an extra precaution. This technology has been used in treatment of other tumors to make the treatment precise. Given these findings, the requested real-time intra-fraction target tracking for planned proton beam radiotherapy 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, I have determined 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 62-year-old male enrollee has requested reimbursement for testing for liver disease provided on 6/11/19. 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 3
A 62-year-old male enrollee has requested reimbursement for testing for liver disease provided on 6/11/19. 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 FibroTest has demonstrated that it reliably determines the presence of advanced fibrosis and cirrhosis in a variety of liver diseases which can cause continuously advancing liver injury, including hepatitis B. It is important to identify cirrhosis early, as it requires specific and routine monitoring, such as ultrasound every six months, to prevent complications. Liver biopsy, by contrast, is invasive, with risks including bleeding and bile duct injury. It is subject to interoperator variability during interpretation and is also subject to sampling error. Thus, testing for liver disease (FibroTest-ActiTest/HCV-FibroSure) provided on 6/11/19 was likely to have been more beneficial than other methods of evaluating this patient.
| 0 |
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 is diagnosed with glioblastoma (GBM). A computed tomography (CT) of the head on 11/3/16 revealed a subtle density within the right frontal lobe. A brain magnetic resonance imaging (MRI) on 11/9/16 revealed a 1.4 x 1.1 x 1.0 cm enhancing right frontal lobe lesion. On 11/18/16, she underwent a craniotomy and resection. Pathology revealed GBM. She then received concurrent radiation and Temodar chemotherapy. Radiation was completed and she was recommended to undergo adjuvant tumor treatment fields (TTF) therapy. 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 TTF delivers alternating electric fields which disrupt mitotic activity. The device delivers electric fields via a portable device through electrodes placed on the patients scalp.
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Overturned
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Experimental
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Summary Reviewer 3
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 is diagnosed with glioblastoma (GBM). A computed tomography (CT) of the head on 11/3/16 revealed a subtle density within the right frontal lobe. A brain magnetic resonance imaging (MRI) on 11/9/16 revealed a 1.4 x 1.1 x 1.0 cm enhancing right frontal lobe lesion. On 11/18/16, she underwent a craniotomy and resection. Pathology revealed GBM. She then received concurrent radiation and Temodar chemotherapy. Radiation was completed and she was recommended to undergo adjuvant tumor treatment fields (TTF) therapy. 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 TTF delivers alternating electric fields which disrupt mitotic activity. The device delivers electric fields via a portable device through electrodes placed on the patients scalp. TTF has been demonstrated to be an effective treatment for this patients disease, which is a disease in which few treatments have ever shown efficacy outside of standard surgery and radiation. It should be recognized that for TTF fields, the randomized data are from large multi-institutional studies by providers who specialize in the treatment of GBM. Thus, compared to other options, 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 patient is a 20-year-old male with a past psychiatric history of intermittent explosive disorder and attention deficit hyperactivity disorder. The patient has requested reimbursement for acute psychiatric inpatient treatment provided from 11/03/21 through 11/13/21. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 20-year-old male with a past psychiatric history of intermittent explosive disorder and attention deficit hyperactivity disorder. The patient has requested reimbursement for acute psychiatric inpatient treatment provided from 11/03/21 through 11/13/21. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. This denial is this subject of this appeal and determination. The physician reviewer found that the American Association of Community Psychiatrists Level of Care Utilization System (LOCUS) provides a reliable framework for determining the appropriate level of care for adults needing mental health treatment. Using LOCUS, providers score patients on a scale of 1-5 using a six-pronged Dimensional Rating System. The six dimensions include: (1) risk of harm; (2) functional status; (3) medical, addictive and psychiatric comorbidity; (4) recovery environment (a. stressors and b. supports); (5) treatment and recovery history; and (6) engagement and recovery status. The composite score is then used to determine the level of care needed. Applying the LOCUS framework, the patient met the criteria for acute psychiatric inpatient services provided from 11/03/21 through 11/13/21. For dimension 1, risk of harm, the records support a score of 5. This dimension assesses potential for harm to self or others, or having harm inflicted upon them. The patient was noted to be unsafe outside of the community. He had poor insight, erratic judgment, and was described as highly explosive. He was involuntarily committed to the inpatient psychiatric facility during the period under review. The patient had been endorsing homicidal ideation. He was described as impulsive. For dimension 2, functional status, the records support a score of 5. This dimension assesses the degree to which a patient is able to fulfill social responsibilities, to interact with others, maintain physical functioning, as well as a patientas capacity for self-care. The records indicate that the patient had been threatening others, was argumentative, was disruptive in the milieu, had engaged in property destruction, and was easily agitated and impulsive. He was isolative from family members. At the time of admission, the patient self-reported that he engaged in property destruction. He also engaged in threatening behavior. For dimension 3, medical, addictive, and psychiatric comorbidity, the records support a score of 2. This dimension assesses the potential complications in the course of illness due to level of acuity or disability related to co-occurring medical illness, substance use disorder, or psychiatric disorder in addition to the presenting disorder. Although the patient denied substance use, his urine toxicology on admission was positive for cannabis. For dimension 4A, level of stress in the recovery environment, the records support a score of 4. This dimension assesses the stressors in the environment, social circumstances, and interpersonal relationships. The patientas recovery environment is highly stressful due to significant conflict with family members as a result of his irritability and poor anger control. The family feels as though they awalk on eggshellsa due to the patientas behavior. For dimension 4B, level of support in the recovery environment, the records support a score of 2. This dimension assesses the resources which enable the individual to maintain health and role functioning, such as availability of adequate material resources, relationships with family members, and the availability of friends, employers, teachers, or others. According to the records, the patientas mother appears to be supportive as evidenced by her willingness to engage with the patientas treatment providers by providing them information about the patient. The patient described his family as supportive. For dimension 5, treatment and recovery history, the records support a score of 5. This dimension assesses how past experiences with treatment and recovery might indicate how the patient might respond in the future. In this patientas case, prior treatment has included weekly psychotherapy, regular psychiatric visits, and psychotropic medication for the last four years. In addition, the records noted one previous inpatient psychiatric admission for similar issues, and he attended a partial hospital program. He had also not responded to the structure and containment of the current hospital milieu. Despite this, the patientas symptoms persisted, and his functional ability has shown no significant improvement. Per the records, the patient has had negligible response to treatment. For dimension 6, engagement and recovery status, the records support a score of 5. This dimension considers a patientas understanding of illness and treatment and ability or willingness to engage in the treatment and recovery process. According to the records, the patient had been refusing medication. He minimized his symptoms and had little insight into his mental illness. These findings give the patient a composite score of 28, which is consistent with Level 6 Medically Managed Residence Services. Per LOCUS, the patientas scores of 5 for risk of harm and functional status also support treatment at Level 6 Medically Managed Residence Based Services level of care. Therefore, acute psychiatric inpatient treatment provided from 11/03/21 through 11/13/21 was medically necessary for the treatment of this patient.
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A 40-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 9/08/16. 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
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Summary Reviewer 3
A 40-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 9/08/16. 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 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. In this patients case, her breasts were described as 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 better enables the possibility of demonstrating an otherwise occult tumor. Thus, digital breast tomosynthesis performed on 9/08/16 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.
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A 64-year-old male insured has requested reimbursement for laboratory testing performed on
5/13/22. The Health Insurer has denied this request indicating that the services at issue were
considered investigational for evaluation of the insureds acute deep vein thrombosis (DVT).
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Upheld
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Experimental
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Summary Reviewer 1
A 64-year-old male insured has requested reimbursement for laboratory testing performed on
5/13/22. The Health Insurer has denied this request indicating that the services at issue were
considered investigational for evaluation of the insureds acute deep vein thrombosis (DVT). The
physician reviewer found that current guidelines from the American College of Chest Physicians
(ACCP) recommend treatment with extended duration anticoagulation after unprovoked venous
thromboembolism unless the risk of bleeding is high or is contrary to the patients values and
preferences (Palareti, et al.). In addition, a recent meta-analysis included 24 studies summarizing
13,571 patients, of which heterozygous Factor V Leiden mutation was identified in 2,840 patients
(Eppenberger, et al.). The authors concluded that against the background of established risk
factors, the Factor V Leiden mutation plays only a marginal role in the risk assessment for
recurrent venous thromboembolism and does not change anticoagulation management. As in
this patients case, the hypercoagulable work-up for Factor V Leiden and Prothrombin G20210A
gene mutation was not recommended in the setting of an unprovoked venous thromboembolism
as it only confers a marginal risk compared to other known factors and does not change
anticoagulation management. Therefore, the laboratory testing performed on 5/13/22 was not
likely to be more beneficial for evaluation of the patients medical condition than any available
standard therapy.
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A 64-year-old female enrollee has requested authorization and coverage for Kadian 50 mg three times per day. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees neck and bilateral shoulder pain.
. The patient has post-laminectomy syndrome with ongoing chronic pain. The patient previously had an intrathecal pain pump which was removed secondary to meningitis. The patient has been maintained on Kadian 50 mg three times per day for over 10 years with appropriate monitoring and safeguards in place. The records document that Kadian 50 mg three times per day keeps her active and allows her to participate in her activities of daily living.
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Overturned
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Medical Necessity
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Summary Reviewer
A 64-year-old female enrollee has requested authorization and coverage for Kadian 50 mg three times per day. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees neck and bilateral shoulder pain. The physician reviewer found that in this case, the request for Kadian 50 mg three times per day is medically necessary and reasonable for management of this patients medical condition. The patient has post-laminectomy syndrome with ongoing chronic pain. The patient previously had an intrathecal pain pump which was removed secondary to meningitis. The patient has been maintained on Kadian 50 mg three times per day for over 10 years with appropriate monitoring and safeguards in place. The records document that Kadian 50 mg three times per day keeps her active and allows her to participate in her activities of daily living. All told, the requested Kadian 50 mg three times per day is supported as medically necessary for treatment of this patients medical condition. Based on the foregoing, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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A 66-year-old male enrollee has requested reimbursement for 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.
This patient has a diagnosis of persistent chronic GERD that has been partly responsive to PPI dosing and behavioral/dietary modification. The patients GERD appeared controlled and the patient was weaned off PPI.
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Upheld
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Experimental
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Summary Reviewer 3
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 that there is sufficient support for the efficacy of the services at issue in this clinical setting. LINX is a minimally invasive anti-reflux procedure that has been approved by the U. S. Food and Drug Administration. The medical literature has shown that the LINX device has less side effects and may have the potential to be completely reversible. This patient has a diagnosis of persistent chronic GERD that has been partly responsive to PPI dosing and behavioral/dietary modification. The patients GERD appeared controlled and the patient was weaned off PPI. Therefore, in the absence of clear data to establish a standard for treatment of GERD, the LINX procedure/device performed on 7/27/16 was likely to be more effective than the other forms of therapy for treatment of this 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.
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A 63-year-old male enrollee has requested authorization and coverage for surgical insertion of an interspinous process spacer. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.
this patient presents with a 20-year history of chronic low back pain. Signs/symptoms
with lumbar spinal stenosis with neurogenic claudication. Clinical examination findings did not evidence a focal neurologic deficit. There is imaging evidence presented from 2016 that showed no significant central canal stenosis and mild bilateral neural foraminal stenosis at L4/5. There is severe degenerative disc disease noted at the L5/S1 level. There is radiographic evidence from 2016 that documented a mild levoscoliosis with apex at L3/4 and anterolisthesis at L4/5 that reduced 2 mm in extension. He has reportedly failed conservative treatment, including activity modification, medications, and lumbar epidural steroid injections.
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Upheld
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Experimental
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Summary Reviewer 1
A 63-year-old male enrollee has requested authorization and coverage for surgical insertion of an interspinous process spacer. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that this patient presents with a 20-year history of chronic low back pain. Signs/symptoms are consistent with lumbar spinal stenosis with neurogenic claudication. Clinical examination findings did not evidence a focal neurologic deficit. There is imaging evidence presented from 2016 that showed no significant central canal stenosis and mild bilateral neural foraminal stenosis at L4/5. There is severe degenerative disc disease noted at the L5/S1 level. There is radiographic evidence from 2016 that documented a mild levoscoliosis with apex at L3/4 and anterolisthesis at L4/5 that reduced 2 mm in extension. He has reportedly failed conservative treatment, including activity modification, medications, and lumbar epidural steroid injections. Current evidence-based medical guidelines and peer-reviewed literature do not fully support the spinal decompression device procedure over the gold standard of lumbar laminectomy. There is a lack of large volume, long-term peer-reviewed outcome studies to support the use of this device for this patients medical condition. Additionally, U.S. Food and Drug Administration (FDA) criteria have not been fully met. FDA indications include implantation of the Superion device at one or two adjacent lumbar levels in patients for whom operative treatment is indicated at no more than two levels from L1 to L5 for a diagnosis of moderate degenerative lumbar spinal stenosis. There is no imaging evidence of moderate spinal stenosis at the L4/5 level on the submitted magnetic resonance imaging (MRI) report. This patients body mass index is documented as 41.28, which is an FDA contraindication. There is no recent documentation of scoliosis films evidencing a Cobb angle of less than 10 degrees, or flexion/extension films showing no progression of the dynamic grade 1 spondylolisthesis noted previously at the L4/5 level, both of which are FDA contraindications. Therefore, the requested surgical insertion of an interspinous process spacer is not likely to be more beneficial than other available standard therapy.
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A 64-year-old female enrollee has requested reimbursement for injection, anesthetic agent, greater occipital nerve, provided on 6/05/19 and 6/12/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition.
This patient has been treated with medications that can help neuropathic pain, without benefit.
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Upheld
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Experimental
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Summary Reviewer 1
A 64-year-old female enrollee has requested reimbursement for injection, anesthetic agent, greater occipital nerve, provided on 6/05/19 and 6/12/19. 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 there are no medications or procedures that have U.S. Food and Drug Administration (FDA) approval for the treatment of occipital headache. Likewise, there are no medications approved for treatment of Chiari malformation related headache. Positional headache as described can represent cervicogenic headache. Standard treatment for this includes diagnostic and therapeutic anesthetic blocks. This patient has been treated with medications that can help neuropathic pain, without benefit. Per the literature, conservative therapeutic approaches are considered first-line. Anesthetic nerve blocks may have a dual role in both supporting diagnosis and providing pain relief. Newer minimally invasive procedures, such as pulsed radiofrequency and occipital nerve stimulation, represent an exciting therapeutic avenue for severe/refractory cases. Surgical interventions should be reserved for select patient populations who have failed all other conservative and minimally invasive options, to be weighed against potential risk. There is considerable evidence that anesthetic blocks and steroids can be beneficial for neuralgia, migraine, and cervicogenic headache. There is sufficient support for the services at issue in this clinical setting. Therefore, injection, anesthetic agent, greater occipital nerve provided on 6/05/19 and 6/12/19 were likely to have been more beneficial than other treatment options.
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An 18-year-old female enrollee has requested reimbursement for intensive outpatient program services provided from 4/25/19 through 7/09/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions.
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Overturned
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Medical Necessity
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Summary Reviewer
An 18-year-old female enrollee has requested reimbursement for intensive outpatient program services provided from 4/25/19 through 7/09/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found that the American Academy of Child and Adolescent Psychiatry and the American Association of Community Psychiatrists Child and Adolescent Level of Care Utilization System (CALOCUS) provides a reliable framework for determining the appropriate level of care for adolescents needing mental health treatment. In terms of risk of harm, the records support a score of 1 due to no recent suicidal ideation and impulsive behaviors. With regards to functional status, the records support a score of 3 due to problems in interpersonal interaction and missing treatment. In terms of medical, addictive and psychiatric comorbidity, the records support a score of 3 due to overall medical stability with evidence of substance use. With regards to level of stress of the recovery environment, the records support a score of 3 due to a non-sober living environment. In terms of level of support of the recovery environment, the records support a score of 3 due to few supportive resources. With regards to treatment and recovery history, the records support a score of 3 due to some treatment response in the intensive outpatient program treatment but consideration of worsening symptoms. In terms of engagement and recovery status, the records support a score of 3 due to fair cooperation in treatment but limited ability to accept responsibility for recovery. Therefore, the patient has a composite score of 19. This score correlates with high intensity community-based services. This level of care is consistent with intensive outpatient program level of care. Therefore, intensive outpatient program services provided from 4/25/19 through 7/09/19 were medically necessary for the treatment of this patient.
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A 52-year-old female enrollee has requested authorization and coverage for gene test (gene expression profiling) performed on 9/20/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee who has been diagnosed with cutaneous melanoma.
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Upheld
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Experimental
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Summary Reviewer 3A 52-year-old female enrollee has requested authorization and coverage for gene test (gene expression profiling) performed on 9/20/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee who has been diagnosed with cutaneous melanoma. The physician reviewer found that DecisionDX melanoma is a commercial gene expression profile test, which has been developed in patients with local (stage I and II) or locoregional (stage III) cutaneous melanoma. The most recent assessment was to determine the impact on clinical practice and therefore did not or was not able to discuss the impact on patient outcome. Version 1.2017 of the National Comprehensive Cancer Network guidelines indicate that for stage II melanoma, that wide excision be pursued with sentinel lymph node evaluation if the tumor is greater than 0.75mm thick. For stage IA, after resection observation is recommended whereas for stage IIB or IIC, interferon alpha should also be considered. There are no current recommendations to undergo genomic or proteomic analysis to assess risk or assess benefit of adjuvant therapy. According to the current guidelines, this data is not definitive. It is unclear if the addition of DecisionDX melanoma to this patients treatment options would have improved her overall care plan since the role in clinical care is still under investigation. As such, the gene test (gene expression profiling) performed on 9/20/16 was not likely to have been superior to other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 59-year-old female enrollee has requested authorization and coverage for heart surgery to correct the heart valve using a catheter (transcatheter valve repair). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.
aortic regurgitation with normal left ventricular size, normal wall thickness and normal ejection fraction on echocardiography dated 11/08/18.
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Overturned
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Experimental
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Summary Reviewer 2
A 59-year-old female enrollee has requested authorization and coverage for heart surgery to correct the heart valve using a catheter (transcatheter valve repair). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that there is a lack of support for the requested services in this clinical setting. The records noted 2-3+ moderate to moderate to severe aortic regurgitation with normal left ventricular size, normal wall thickness and normal ejection fraction on echocardiography dated 11/08/18. Therefore, the records do not support severe aortic regurgitation. In the setting of chronic severe aortic regurgitation, ventricular dilation and hypertrophy develop, which is not documented in this case. Many other conditions the patient has may also cause exertional dyspnea. There is no catheterization data to support that aortic regurgitation is a significant contributor as evidenced by elevated left ventricular end-diastolic pressure. Transcatheter aortic valve replacement has not been adequately evaluated for patients with primarily aortic regurgitation, as opposed to aortic valve stenosis. In sum, the superior efficacy of the requested heart surgery to correct the heart valve using a catheter (transcatheter valve repair) has not been established.
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A 65-year-old female enrollee has requested reimbursement for the repair of nasal vestibular stenosis performed on 7/28/17. The Health Insurer has denied this request indicating that the surgery at issue was not medically necessary for treatment of the enrollees chronic sinusitis.
bstruction. This patient had valve collapse and a positive Cottle maneuver.
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Overturned
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Medical Necessity
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Summary Reviewer
A 65-year-old female enrollee has requested reimbursement for the repair of nasal vestibular stenosis performed on 7/28/17. The Health Insurer has denied this request indicating that the surgery at issue was not medically necessary for treatment of the enrollees chronic sinusitis. The physician reviewer found nasal valve collapse is a common cause of nasal airway obstruction. Although many techniques have been devised to correct the functional and aesthetic aspects of this problem, none have been demonstrated to be uniformly successful. One solution to the problem may lie lateral to the nasal valve angle in the fibroareolar tissue that connects the lateral aspect of the lateral crus to the bony pyriform aperture. Age-related or surgically induced weakening and loosening of these structurally important, fibroareolar connections can result in a prolapse of the lateral aspect of the lateral crural away from the pyriform margin and toward the septum with a consequent narrowing of the nasal valve region. This narrowing can lead to nasal obstruction. This patient had valve collapse and a positive Cottle maneuver. Thus, the vestibular stenosis repair should improve her nasal breathing. Accordingly, the repair of vestibular stenosis performed on 7/28/17 was medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the surgery at issue was medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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A 55-year-old male enrollee has requested authorization and coverage for esketamine (Spravato) nasal spray (code C9399), 68-84 mg intranasal for one month, then up to two times weekly. 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
the records indicate that the patient has a history of depression as well as anxiety. Progress notes indicate that the patient has had unsuccessful trials of electroconvulsive therapy and transcranial magnetic stimulation. The progress notes indicate the patient has had a long history of treatment-resistant depression, which appears to be an area where ketamine has been clinically indicated.
the patient has had a positive response from esketamine in the recent past.
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Overturned
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Medical Necessity
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Summary Reviewer
A 55-year-old male enrollee has requested authorization and coverage for esketamine (Spravato) nasal spray (code C9399), 68-84 mg intranasal for one month, then up to two times weekly. 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 records indicate that the patient has a history of depression as well as anxiety. Progress notes indicate that the patient has had unsuccessful trials of electroconvulsive therapy and transcranial magnetic stimulation. The progress notes indicate the patient has had a long history of treatment-resistant depression, which appears to be an area where ketamine has been clinically indicated. Andrade noted that although big data on ketamine are presently unavailable, the drug holds promise in the treatment of depression, especially refractory depression. The progress notes indicate that the patient has had a positive response from esketamine in the recent past. Overall, the literature shows some mixed results with regards to ketamine treatment as well as a lack of long-term outcomes data and safety data. However, the patient has failed evidence-based treatments for treatment-resistant depression, including multiple medication trials, medication augmentation strategies, transcranial magnetic stimulation, electroconvulsive therapy and psychotherapy. There is sufficient support for the requested medication in this clinical setting. Therefore, esketamine (Spravato) nasal spray (code C9399), 68-84 mg intranasal for one month, then up to two times weekly is medically necessary for the treatment of this patient.
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A 21-year-old female enrollee has requested reimbursement for knee arthroscopy synovectomy performed on 12/20/17. 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 female enrollee has requested reimbursement for knee arthroscopy synovectomy performed on 12/20/17. 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 Synovial plica are folds in the lining of the knee joint which are sometimes sources of painful abrasion against the medial femoral condyle. The meta-analysis by Gerrard and Charalambous noted arthroscopic surgical management of symptomatic medial knee plica results in favorable outcomes. Our results suggest that arthroscopic surgical excision should be considered as a treatment modality in patients with pathological medial plica disease of the knee either as a first-line treatment or when symptoms have not responded to non-surgical interventions. Partial synovectomy for resection of symptomatic plica is a standard procedure. This patient had substantial knee pain despite nonsurgical treatment. Thus, knee arthroscopy synovectomy performed on 12/20/17 was likely to have been more beneficial than other treatment options.
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A 60-year-old female enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C.
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Overturned
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Medical Necessity
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Summary Reviewer
A 60-year-old female enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C. The physician reviewer found according to the most recent joint guidelines issued by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, all patients with chronic hepatitis C, regardless of fibrosis, should be treated except those with limited life expectancy less than 12 months due to non-liver-related conditions. In treatment-naive patients with hepatitis C, genotype 1 infection, treatment with Harvoni is recommended. Additionally, treatment of patients before they progress to cirrhosis is advantageous. Based on evidence of safety and efficacy in the published literature, and clinical guidelines, Harvoni is medically indicated for the treatment of this patient. Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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A 52-year-old male requested authorization and coverage for hypoglossal stimulator. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees obstructive sleep apnea.
that the patient has been diagnosed with obstructive sleep apnea (OSA). The sleep study
is over eight years old and it shows only hypopnea events with no obstructive apnea events. The patient has failed Provent, CPAP, BiPAP, and dental device. The Inspire
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Upheld
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Experimental
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Summary Reviewer 1
A 52-year-old male requested authorization and coverage for hypoglossal stimulator. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees obstructive sleep apnea. The physician reviewer found that the patient has been diagnosed with obstructive sleep apnea (OSA). The sleep study that is available is over eight years old and it shows only hypopnea events with no obstructive apnea events. The patient has failed Provent, CPAP, BiPAP, and dental device. The Inspire device is U.S. Food and Drug Administration approved for the treatment of OSA when certain criteria are met. However, this patients sleep study is over eight years old. As such, the documentation is lacking to support the superior efficacy of the requested services over the standard options available for treating this patients medical condition.
Therefore, for the reasons stated above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 36-year-old female enrollee has requested reimbursement for AmnioMatrix or BioDMatrix injectable, 1 cc provided on 2/01/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee, who underwent open reduction and internal fixation.
the operative note dated 2/01/18 advises that a 10 mm and 12 mm 2.0 Synthes screw was utilized to fixate the fracture. The operative note indicated that
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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 AmnioMatrix or BioDMatrix injectable, 1 cc provided on 2/01/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee, who underwent open reduction and internal fixation. The physician reviewer found that the operative note dated 2/01/18 advises that a 10 mm and 12 mm 2.0 Synthes screw was utilized to fixate the fracture. The operative note indicated that excellent fixation and anatomic reduction was achieved. No other pathology was noted in the operative note that would require additional measures to improve healing. Furthermore, amniotic membranes and other graphs similar to this are authorized for the use of ulcerations of the skin. In this particular case, it was utilized in between a deep and superficial closure after a fracture fixation. While the literature on amniotic grafts do demonstrate promise when utilized for skin ulceration closure, there is a lack of support for the services at issue in this clinical setting. Therefore, AmnioMatrix or BioDMatrix injectable, 1 cc provided on 2/01/18 was not likely to have been more effective than other treatment options. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 58-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma (laboratory service code 84999) rendered on 8/25/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees cutaneous melanoma.
. The physician reviewer found that this patient is a 58-year-old male with a melanoma on his left anterior shoulder measuring .51mm Breslow depth. His provider sent a tissue sample for molecular genetic testing to help determine the risk of metastasis of the tumor. The patient has requested reimbursement for DecisionDx-Melanoma (laboratory service code 84999) rendered on 8/25/17. The Health Insurer denied this request for reimbursement. Per the Health Insurer, the services at issue were considered investigational for the evaluation of this patients melanoma.
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Upheld
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Experimental
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Summary Reviewer 3
A 58-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma (laboratory service code 84999) rendered on 8/25/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees cutaneous melanoma.
. The physician reviewer found that this patient is a 58-year-old male with a melanoma on his left anterior shoulder measuring .51mm Breslow depth. His provider sent a tissue sample for molecular genetic testing to help determine the risk of metastasis of the tumor. The patient has requested reimbursement for DecisionDx-Melanoma (laboratory service code 84999) rendered on 8/25/17. The Health Insurer denied this request for reimbursement. Per the Health Insurer, the services at issue were considered investigational for the evaluation of this patients melanoma. There is a lack of formal standard procedures or precautions that would be changed in light of the data provided by these molecular testing. Currently, there is a paucity of evidence to support its use in this clinical setting. The DecisionDx-Melanoma assay tests the tissue genetics of the melanoma and can stratify whether a melanoma is high risk for metastasis or not. The test examines gene markers and then the lesion can be further stratified to tell if it is high risk for metastasis. This test has shown some accuracy determining risk of metastasis; however, decision-making based on the results of the test is indeterminate at this time. There is limited scientific evidence permitting conclusions concerning the effect of this test on health outcomes and there is not enough published data to support its routine use. The treatment of this patient would not change based on the results of the examination. Moreover, the test is not considered standard of care for treatment of patients in this clinical setting. Formal standard procedures or precautions that would be changed in light of the data is lacking. The current standard of care would be to perform a wide local excision. Since this test does not provide a superior benefit over established tests in terms of outcomes, DecisionDx-Melanoma (laboratory service code 84999) rendered on 8/25/17 was not likely to have been more beneficial for the evaluation of this patients medical condition than any available standard modalities. Therefore, for the reasons stated above, the services at issue were not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 54-year-old male enrollee has requested reimbursement for the Prometheus diagnostic panel performed on 11/24/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 2
A 54-year-old male enrollee has requested reimbursement for the Prometheus diagnostic panel performed on 11/24/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that the Prometheus diagnostic panel performed on 11/24/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. According to the article by Dontan the correlation between serologic markers and genetic variations may contribute to reclassifying IBD into new and more homogeneous subclasses. Their significance in diagnosing populations at risk, such as unaffected relatives of IBD patients and [Crohns disease] CD patients prior to diagnosis, is under current investigation. In sum, the reliance on marker testing to assess whether a patient has IBD, without definitive mucosal inspection and sampling is not the standard of care. 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.
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The parent of a 16-month-old female enrollee has requested authorization and coverage for hourly pediatric nursing, 12 hours per day, seven days per week (S9123). The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition.
has a number of problems as a result of, and in addition to, her cloacal abnormalities, chronic kidney disease, and prematurity.
With the introduction of skilled nursing services, she has had no further significant urinary tract infections requiring parenteral antibiotics and hospitalization. She has been able to attend preschool to aid in her development and help her to catch up to her peers. The patients mother is the primary caregiver and has significantly modified her schedule in order to provide for the patients custodial needs. She does not have
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Medical Necessity
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Summary Reviewer
The parent of a 16-month-old female enrollee has requested authorization and coverage for hourly pediatric nursing, 12 hours per day, seven days per week (S9123). The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that this medically fragile patient has a number of problems as a result of, and in addition to, her cloacal abnormalities, chronic kidney disease, and prematurity. The most important issue for her at this time, prior to completion of her reconstructive surgeries, is prevention of urinary tract infection and preservation of renal function. With the introduction of skilled nursing services, she has had no further significant urinary tract infections requiring parenteral antibiotics and hospitalization. She has been able to attend preschool to aid in her development and help her to catch up to her peers. The patients mother is the primary caregiver and has significantly modified her schedule in order to provide for the patients custodial needs. She does not have the necessary expertise, however, to provide for the patients skilled medical needs, including ostomy care and prevention of urinary tract infections. The requested skilled nursing services 12 hours daily 7 days per week are essential to this patients current health as well as to the future success of her reconstructive surgeries. Therefore, the requested hourly pediatric nursing, 12 hours per day, seven days per week (S9123), is medically necessary for the treatment of this patient.
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The parent of a 10-year-old male enrollee has requested reimbursement for the functional neuromuscular electrical stimulator-arms therapy system provided on 4/16/20. The Health Insurer has denied this request and reported that the device at issue was investigational for the treatment of the enrollees medical condition.
has permanent neurological disability after a spinal cord injury.
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Experimental
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Summary Reviewer 1
The parent of a 10-year-old male enrollee has requested reimbursement for the functional neuromuscular electrical stimulator-arms therapy system provided on 4/16/20. The Health Insurer has denied this request and reported that the device at issue was investigational for the treatment of the enrollees medical condition. The physician reviewer found that the current medical evidence supports the device at issue in this clinical setting. The RT300 FES Therapy System has been approved by the U.S. Food and Drug Administration. The patient has permanent neurological disability after a spinal cord injury. This device has been recommended as the best treatment option by his treating physicians as part of his rehabilitation program. There is medical literature supporting the device at issue in this setting. Therefore, the functional neuromuscular electrical stimulator-arms therapy system provided on 4/16/20 was likely to have been more beneficial than any available standard therapy.
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A 57-year-old female enrollee has requested reimbursement and prospective authorization and coverage for chemical dependency residential treatment provided from 2/15/19 through 2/20/19. The Health Insurer has denied this request and reported that the services at issue were not and are not medically necessary for the treatment of the enrollees behavioral health conditions.
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Overturned
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Medical Necessity
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Summary Reviewer
A 57-year-old female enrollee has requested reimbursement and prospective authorization and coverage for chemical dependency residential treatment provided from 2/15/19 through 2/20/19. The Health Insurer has denied this request and reported that the services at issue were not and are not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found that the submitted documentation supports the medical necessity of the services at issue. The American Psychiatric Association indicates that residential treatment may be indicated for patients who do not meet the clinical criteria for hospitalization but whose lives and social interactions have come to focus predominantly on substance use, and who lack sufficient social and vocational skills and drug-free social supports to maintain abstinence in an outpatient setting. Patients require safe and stable living environments in order to develop their recovery skills. The purpose of detoxification is to make the patient physically stable and safe. Rehabilitation is the essential component that should follow detoxification in order to help the patient maintain sobriety and reduce the risk of relapse. Given the severity of the patients illness, including her continuing to consume alcohol despite severe hepatic impairment while on a liver transplant waitlist, residential treatment was in accordance with generally accepted standards of medical practice and clinically appropriate for the patients illness. Therefore, chemical dependency residential treatment provided from 2/15/19 through 2/20/19 was medically necessary for the treatment of this patient.
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A 58-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 2/20/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma.
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Upheld
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Experimental
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Summary Reviewer 1
A 58-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 2/20/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that there is a lack of support for the services at issue in this clinical setting. As patients diagnosed with stage I or II melanoma are generally viewed as having a low risk of metastasis, treatment planning is limited to surgical excision of the primary tumor followed by routine skin examinations and clinical examination. There is rarely any systemic surveillance imaging, further lymph node interrogation or recommendation for adjuvant therapy. In contrast, patients diagnosed with stage III melanoma receive complete lymph node dissection, active surveillance measures and often, referral to medical oncology for adjuvant medical therapy and clinical trial participation. The DecisionDx-Melanoma gene expression profile test is an expression assay designed to predict distant metastasis in stage I and stage II melanoma patients. DecisionDx-Melanoma assesses the expression of 31 genes that have been associated with metastasis and classifies tumors as Class 1 (i.e., low risk of metastasis) or Class 2 (i.e., high risk of metastasis). However, the medical evidence has not established that DecisionDx-Melanoma testing is likely to be more effective than other standard methods of evaluating this patient. Therefore, DecisionDx-Melanoma testing performed on 2/20/18 was not likely to have been superior over other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The patient is a 66-year-old man with lumbar stenosis. The patient has requested authorization and coverage for lumbar spine surgery (laminectomy, facetectomy and foraminotomy, single vertebral segment). The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient.
The patient has severe lumbar stenosis with neurogenic claudication.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 66-year-old man with lumbar stenosis. The patient has requested authorization and coverage for lumbar spine surgery (laminectomy, facetectomy and foraminotomy, single vertebral segment). 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. The patient has severe lumbar stenosis with neurogenic claudication. Decompression is well supported by the referenced literature to reduce pain and increase function. The current medical evidence supports the requested services in this patientas case. Therefore, the requested lumbar spine surgery (laminectomy, facetectomy and foraminotomy, single vertebral segment) is medically necessary for the treatment of this patient.
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A 56-year-old female enrollee has requested authorization and coverage for radiofrequency neurolysis. The Health Insurer has denied this request indicating that the requested service is considered investigational for treatment of the enrollees low back pain.
In addition, the patient was previously treated with radiofrequency ablation which provided pain relief which lasted almost 11 months.
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Overturned
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Experimental
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Summary Reviewer 1
A 56-year-old female enrollee has requested authorization and coverage for radiofrequency neurolysis. The Health Insurer has denied this request indicating that the requested service is considered investigational for treatment of the enrollees low back pain. The physician reviewer found the request for radiofrequency neurolysis is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. There is medical literature supporting the utility of radiofrequency neurolysis in this clinical setting. In addition, the patient was previously treated with radiofrequency ablation which provided pain relief which lasted almost 11 months. As such, the request for radiofrequency neurolysis is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested service is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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The patient is a five-year old male who has been diagnosed with autism spectrum disorder. . The patientas parent has requested reimbursement and prospective authorization and coverage for applied behavior analysis (43.5 hours per week of code 97135 and 18 hours per month of code 97155) provided from 10/06/20 through 4/06/21. The Health Insurer has denied this request and reported that the services at issue were not and are not medically necessary.
Per the records, the patient is actively working on goals. In an undated letter, the patientas provider requested 40 hours of one-to-one applied behavior analysis, which is well within current treatment guidelines.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a five-year old male who has been diagnosed with autism spectrum disorder. . The patientas parent has requested reimbursement and prospective authorization and coverage for applied behavior analysis (43.5 hours per week of code 97135 and 18 hours per month of code 97155) provided from 10/06/20 through 4/06/21. The Health Insurer has denied this request and reported that the services at issue were not and are not medically necessary. The physician reviewer found that the submitted documentation supports the medical necessity of a portion of the services at issue. Based on the submitted documentation, 40 hours per week of 97135 are medically necessary and 16 hours per month of code 97155 are medically necessary. Per the records, the patient is actively working on goals. In an undated letter, the patientas provider requested 40 hours of one-to-one applied behavior analysis, which is well within current treatment guidelines. Behavior Analyst Certification Board guidelines note, aTreatment hours are subsequently increased or decreased based on the clientas response to treatment and current needs. Hours may be increased to more efficiently reach treatment goals. Decreases in hours of therapy per week typically occur when a client has met a majority of the treatment goals and is moving toward discharge.a As this patient is actively work on goals, is making progress, and is not yet ready for discharge, 40 hours per week of code 97135 is appropriate. Additionally, the request for 40 hours of code 97135 per week meets the medical necessity criteria set by Papatola and Lustig. Their definition includes ahealth-care services that a provider, exercising a prudent clinical judgment, would provide to a patient for the purpose of evaluating, diagnosing, or treating an illness, injury, disease, or its symptoms and are (a) required to meet the essential health needs of the patient; (b) consistent with the diagnosis of the condition for which they are required; (c) consistent in type, frequency, and duration of treatment with scientifically based guidelines as determined by medical research; (d) required for purposes other than the convenience of the provider or the comfort of the patient; and (e) rendered in the least intensive setting that is appropriate for the delivery of health care.a Applied behavior analysis is the most effective treatment for autism, thus is essential to meet the patientas needs. Similarly, applied behavior analysis is consistent with the diagnosis of autism. With regard to code 97155, 16 hours per month is medically appropriate, as this is 10% of the one-to-one applied behavior analysis which will be provided. Therefore, 40 hours per week of code 97135 and 16 hours per month of code 97155 from 10/06/20 through 4/06/21 were and are medically necessary for the treatment of this patient.
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A 52-year-old female enrollee has requested authorization and coverage for matrix-assisted autologous chondrocyte implantation (MACI) procedure. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees knee pain.
. She is status post bilateral knee arthroscopy, chondroplasty, synovectomy, and plica resection, and chondral biopsy on the right knee on 7/18/18. The surgeon reports right knee operative findings including a full thickness grade III/IV chondral defect on the lateral facet of the patella measuring 2.5 x 2.5 cm, and a full thickness grade III defect on the trochlea measuring 1.5 x 1.5 cm. The left knee had similar findings with grade IV chondral defect in the lateral facet of the patella measuring 2 x 2 cm, and a grade III defect on the anterolateral trochlea measuring 5 x 5 mm. All defects had been debrided back to stable margins
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Experimental
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Summary Reviewer 2
A 52-year-old female enrollee has requested authorization and coverage for matrix-assisted autologous chondrocyte implantation (MACI) procedure. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees knee pain. The physician reviewer found that the records document a history of progressively worsening bilateral knee pain. Functional difficulty is reported in activities of daily living and recreational pursuits. She is status post bilateral knee arthroscopy, chondroplasty, synovectomy, and plica resection, and chondral biopsy on the right knee on 7/18/18. The surgeon reports right knee operative findings including a full thickness grade III/IV chondral defect on the lateral facet of the patella measuring 2.5 x 2.5 cm, and a full thickness grade III defect on the trochlea measuring 1.5 x 1.5 cm. The left knee had similar findings with grade IV chondral defect in the lateral facet of the patella measuring 2 x 2 cm, and a grade III defect on the anterolateral trochlea measuring 5 x 5 mm. All defects had been debrided back to stable margins with Outerbridge grade I/II at the lesion borders. Detailed evidence of recent nonoperative treatment protocol trial and failure has been submitted. There is U.S. Food and Drug Administration (FDA) approval for the use of MACI in this clinical scenario. There is current peer-reviewed evidence indicating that MACI is safe and effective for treatment of full thickness cartilage defects in the knee, with no effect of the location of the defects or number of defects on study outcomes. Therefore, the requested MACI procedure is likely to be superior over other treatment options. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A year-old female enrollee has requested reimbursement for collagen crosslink testing provided on 4/17/19. 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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Experimental
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Summary Reviewer 3
A year-old female enrollee has requested reimbursement for collagen crosslink testing provided on 4/17/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that the use of bone turnover markers is standard practice among endocrinologists and other specialists in osteoporosis. It is used as a guide to monitor compliance and efficacy of treatment. It also helps to identify non-responders that require additional work-up for other causes of osteoporosis. In this case, the patients provider planned to use the information from this test result to determine whether the patient may resume therapy for osteoporosis and subsequently to monitor therapy. Naylor and colleagues noted that measurement of bone turnover markers after withdrawal of bisphosphonates is potentially useful to evaluate patients that are taking a pause from treatment. Thus, collagen crosslink testing provided on 4/17/19 was likely to have been more beneficial than other methods of evaluating this patient.
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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 initially underwent surgical resection for a glioblastoma. She went on to receive chemotherapy and radiation therapy and has started treatment with tumor treatment fields (TTF) with Optune. 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.
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Experimental
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Summary Reviewer 2
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 initially underwent surgical resection for a glioblastoma. She went on to receive chemotherapy and radiation therapy and has started treatment with tumor treatment fields (TTF) with Optune. 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. TTF with the Optune device is supported in the peer-reviewed medical literature for patients in the treatment of glioblastoma. One phase three study that examined the outcomes of patients with and without TTF found an improvement in survival (Stupp, et al). Moreover, TTF has not been associated with any major side effects. As a result, national guidelines from the National Comprehensive Cancer Network (NCCN) endorse the use of this device. Therefore, Optune device with transducer arrays provided from 3/8/17 forward was and is likely to be more beneficial for the treatment of the patients condition than 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.
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A 42-year-old female enrollee has requested reimbursement for DecisionDx Melanoma testing (84999) performed on 1/23/17. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees cutaneous melanoma.
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Upheld
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Experimental
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Summary Reviewer 2
A 42-year-old female enrollee has requested reimbursement for DecisionDx Melanoma testing (84999) performed on 1/23/17. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Although DecisionDx Melanoma may be an independent predictor of metastasis risk, there is a lack of peer-reviewed published studies confirming this hypothesis. For this reason, the DecisionDx Melanoma testing (CPT code 84999) performed on 1/23/17 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.
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A 48-year-old female enrollee has requested authorization and coverage for a Cochlear Baha Attract System. The Health Insurer has denied this request indicating that the requested services are considered 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 48-year-old female enrollee has requested authorization and coverage for a Cochlear Baha Attract System. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The physician reviewer found that The Cochlear Baha Attract System has not been established as likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Although the Cochlear Baha Attract System is approved by the U.S. Food and Drug Administration, in this patients case it is not likely to be more beneficial than the traditional Baha Connect System. Based on the medical literature and clinical documentation submitted for review, 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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A 53-year-old female enrollee has requested authorization and coverage for foam sclerosant/endovenous ablation. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.
. This patient has painful varicose veins bilaterally. She is status post radiofrequency ablation of left great saphenous vein and ultrasound-guided foam sclerotherapy. There is support for the requested services for the left leg. For the left leg, the veins are residual after a prior thermal ablation. She continues to be symptomatic.
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Overturned
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Experimental
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Summary Reviewer 3
A 53-year-old female enrollee has requested authorization and coverage for foam sclerosant/endovenous ablation. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that there is support for a portion of the services at issue. This patient has painful varicose veins bilaterally. She is status post radiofrequency ablation of left great saphenous vein and ultrasound-guided foam sclerotherapy. There is support for the requested services for the left leg. For the left leg, the veins are residual after a prior thermal ablation. She continues to be symptomatic. Thus, the requested services for the left leg are likely to be superior over other treatment options. With regards to the right leg, the varicose veins are de novo. There is no saphenofemoral junction or saphenopopliteal junction reflux. Per the medical evidence, endovenous thermal ablation is preferred to surgery and foam sclerotherapy in the treatment of small saphenous vein incompetence. In sum, the requested foam sclerosant/endovenous ablation of the left leg is likely to be of greater benefit than other treatment options.
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A 34-year-old female enrollee has requested authorization and coverage for an MRI of the abdomen. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the evaluation of the enrollees medical condition.
this patient has a genetic mutation, PRSS1, which is associated with hereditary pancreatitis,
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Overturned
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Medical Necessity
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Summary Reviewer
A 34-year-old female enrollee has requested authorization and coverage for an MRI of the abdomen. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that this patient has a genetic mutation, PRSS1, which is associated with hereditary pancreatitis, a markedly elevated risk of pancreatic cancer. It is also associated with risk of chronic pancreatitis, which causes the diarrhea and bloating symptoms, which the patient presented with. Given the increased risk of pancreatic cancer at a young age in patients with PRSS1 mutations, American Gastroenterological Association Institute guidelines for screening in patients with genetic predisposition for pancreatic cancer state that screening should be initiated at age 40. However, there is a significant rate of pancreatic cancer at young ages (8% before age 50), some of which could be missed by strict adherence to these guidelines. Separately, the patient is at risk for elevated chronic pancreatitis, and has symptoms consistent with this. Identification of chronic pancreatitis early may delay or prevent morbidity. MRI is reported to be a better diagnostic test than computed tomography scan for diagnosis, and endoscopic ultrasound is associated with higher procedural risk than magnetic resonance imaging, especially in the setting of Ehlers-Danlos syndrome. Therefore, the requested MRI of the abdomen is medically necessary for the evaluation of this patient.
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patient is a 56-year-old female with a history of muscle and joint pain. The patient was treated
with several medications to combat the muscle and joint pain and was referred to a chiropractor,
without significant benefit. The patient underwent a removal of intact breast implant on 4/7/22.
The Health Insurer has denied the services at issue as not medically necessary for the treatment of
the patients medical condition.
, the patient has a history of severe
back, neck, torso, chest, and joint pain due to her breasts.
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Upheld
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Medical Necessity
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Summary
The patient is a 56-year-old female with a history of muscle and joint pain. The patient was treated
with several medications to combat the muscle and joint pain and was referred to a chiropractor,
without significant benefit. The patient underwent a removal of intact breast implant on 4/7/22.
The Health Insurer has denied the services at issue as not medically necessary for the treatment of
the patients medical condition. This denial is the subject of this appeal and determination. The
physician reviewer found that according to Wee and colleagues, while some studies have observed
overall symptomatic improvement after breast implant removal, There is a lack of studies
evaluating changes in specific symptoms over time. In this case, the patient has a history of severe
back, neck, torso, chest, and joint pain due to her breasts. The records provided for review suggest
that the patients muscle and joint pain were due to the size of the breast implant rather than breast
implant illness (BII). Loss of range of motion is not associated with BII but is instead most likely
secondary to a large implant. The patients symptoms overall are secondary to complications of
implant size and that of a cosmetic procedure. Early capsular contracture would not result in
limited range of motion and diffuse symptoms. Given these findings, the removal of intact breast
implant performed on 4/7/22 was not medically necessary for the treatment of this patient.
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The parent of a six-year-old male enrollee has requested reimbursement and prospective authorization and coverage for mental health applied behavioral analysis from 1/13/19 through 7/13/19 (30 hour per week one-to-one therapy and H0031, 6 hours per month). The Health Insurer has denied this request and reported that the services at issue were not and are not medically necessary for the treatment of the enrollees medical condition.
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Overturned
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Medical Necessity
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Summary Reviewer
The parent of a six-year-old male enrollee has requested reimbursement and prospective authorization and coverage for mental health applied behavioral analysis from 1/13/19 through 7/13/19 (30 hour per week one-to-one therapy and H0031, 6 hours per month). The Health Insurer has denied this request and reported that the services at issue were not and are not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the medical necessity of the services at issue. The treatment authorization request included over 35 goals, most being social in nature. The purpose of supporting the patient in the educational settings is to provide training on social interactions with typical/same aged peers in a more naturalistic setting. The Behavior Analyst Certification Board (BACB) highlights that services are provided in multiple locations, including school settings, to promote generalization and maintenance of treatment gains. Further, the number of goals identified necessitates the treatment intensity described. The medical evidence supports the services at issue in this clinical setting. Therefore, mental health applied behavioral analysis from 1/13/19 through 7/13/19 (30 hours per week one-to-one therapy and H0031, six hours per month) was and is medically necessary for the treatment of this patient.
| 0 |
A 23-year-old female enrollee has requested reimbursement for genotype testing performed on 11/10/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees behavioral health conditions.
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Upheld
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Experimental
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Summary Reviewer 1
A 23-year-old female enrollee has requested reimbursement for genotype testing performed on 11/10/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees behavioral health conditions. The physician reviewer found that there is a lack of support for the services at issue in this patients case. Pharmacogenetics deals with the differences in effect of drugs due to individuals genetic variations. This testing may be beneficial for treatment-resistant patients in order to help predict response to certain medications. In this case, the records do not demonstrate that the patient was treatment-resistant. In this setting, the services at issue were not consistent with standards of good medical practice. Therefore, genotype testing performed on 11/10/17 was not likely to have been more effective than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 60-year-old female enrollee has requested reimbursement for methylenetetrahydrofolate reductase (MTHFR) and nerve conduction velocity (NCV) studies provided on 9/22/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Hashimotos thyroiditis.
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Overturned
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Experimental
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Summary Reviewer 1
A 60-year-old female enrollee has requested reimbursement for methylenetetrahydrofolate reductase (MTHFR) and nerve conduction velocity (NCV) studies provided on 9/22/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Hashimotos thyroiditis. The physician reviewer found that the Thyroid Trio testing comprises three different tests that are not routinely recommended by providers caring for patients with thyroid problems. There is a lack of medical literature supporting the utility of the MTHFR and NCV studies in this clinical setting. Further, the American Thyroid Association Task Force on Thyroid Hormone Replacement does not include the testing used in this case for evaluation of this patients medical condition. All told, the MTHFR and NCV studies performed on 9/22/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 64-year-old male enrollee has requested authorization and coverage for PET scan with CT for attenuation. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the evaluation of the enrollees medical condition.
, the patient is not currently being treated with a tyrosine kinase inhibitor.
. The records indicate that the patient was evaluated with a CT of the chest on 4/12/19.
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Upheld
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Medical Necessity
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Summary Reviewer
A 64-year-old male enrollee has requested authorization and coverage for PET scan with CT for attenuation. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that PET/CT is one of the most useful imaging examinations for the staging of malignancy, detection of recurrence or metastases, and monitoring of treatment response. Although the value of PET/CT is limited for the diagnosis of renal cell carcinoma due to renal excretion of fluorodeoxyglucose (FDG), PET/CT has been increasingly utilized to evaluate treatment response to targeted therapies, such as tyrosine kinase inhibitors. It has been shown that tumor size is not an accurate indicator of tumor response to these new targeted therapies, and functional imaging is more accurate. In this case, the patient is not currently being treated with a tyrosine kinase inhibitor. A follow-up chest CT is the appropriate imaging examination to assess pulmonary metastases. The records indicate that the patient was evaluated with a CT of the chest on 4/12/19. The results were adequate for appropriate monitoring of the patient. Only if the results were substantially equivocal would a PET/CT be indicated, and they were not. Therefore, the requested PET with CT for attenuation is not medically necessary for the evaluation of this patient.
| 1 |
A 30-year-old male enrollee has requested reimbursement for immunoglobulin heavy chain locus gene rearrangement and immunoglobulin kappa light chain locus gene arrangement testing performed on 2/14/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 1
A 30-year-old male enrollee has requested reimbursement for immunoglobulin heavy chain locus gene rearrangement and immunoglobulin kappa light chain locus gene arrangement testing performed on 2/14/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that leukemia and lymphoma are the most common causes of unexplained fever. Most patients with T-cell large granular lymphocyte (LGL) leukemia present with symptoms related to neutropenia. Fever with recurrent bacterial infections occurs in 20 to 40 percent of patients. LGL leukemia is a chronic illness. Usually, there is history of a gradual decline in counts over time. Diagnosis includes evaluation of T-cell rearrangements. B-lymphoblastic leukemia and lymphoma are overlapping clinical manifestations of the same disease. The tempo of disease is variable. Some patients present with symptoms that progress slowly over weeks to months, while others have a more acute presentation. Nearly all cases of B-cell acute lymphoblastic leukemia have rearrangements of immunoglobulin heavy chain (IGH), but up to 70 percent of cases also have rearrangements of the T-cell receptor (TCR) gamma or beta chain genes. Molecular techniques that can detect clonal populations of lymphocytes include polymerase chain reaction (PCR) and DNA sequencing. These techniques can demonstrate the presence of a dominant clone of cells based on rearrangements of either immunoglobulin genes (in B lymphocyte) or T-cell receptor genes (in T cells) and can include immunoglobulin heavy chain locus gene rearrangement and immunoglobulin kappa light chain locus gene. The services at issue were part of standard testing. Therefore, immunoglobulin heavy chain locus gene rearrangement and immunoglobulin kappa light chain locus gene arrangement testing performed on 2/14/19 were likely to have been more beneficial than other methods of evaluating this patient.
| 1 |
The parent of a 17-year-old male enrollee has requested reimbursement for Prometheus Anser IFX testing performed on 6/30/14. The Health Insurer has denied this request indicating that the services at issue were 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
The parent of a 17-year-old male enrollee has requested reimbursement for Prometheus Anser IFX testing performed on 6/30/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the submitted documentation fails to demonstrate the superior efficacy of the services at issue. There is a lack of controlled data to support measurement of infliximab levels after completing an induction dose of Remicade. Theoretically, one could find the unique dose requirement for each patient and tailor therapy individually. However, this approach has not been shown to lead to improved outcomes. There is a lack of support for the services at issue in this clinical setting. Therefore, Prometheus Anser IFX testing was not likely to have been of greater benefit than other methods of evaluation. 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 28-year-old female enrollee has requested reimbursement and prospective authorization and
coverage for ketamine infusions from 9/07/21 forward. The Health Insurer has denied this
request and reported that the services at issue were and are investigational for the treatment of
the enrollees medical condition.
that the patient has a history of
major depressive disorder that has not responded to multiple antidepressants, dialectical
behavior therapy, eye movement desensitization and reprocessing, and transcranial magnetic
stimulation. Her provider recommended intravenous ketamine infusions for treatment-resistant
depression. Per the psychiatrist, the ketamine infusions have
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Overturned
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Experimental
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Summary Reviewer 2
A 28-year-old female enrollee has requested reimbursement and prospective authorization and
coverage for ketamine infusions from 9/07/21 forward. The Health Insurer has denied this
request and reported that the services at issue were and are investigational for the treatment of
the enrollees medical condition. The physician reviewer found that the patient has a history of
major depressive disorder that has not responded to multiple antidepressants, dialectical
behavior therapy, eye movement desensitization and reprocessing, and transcranial magnetic
stimulation. Her provider recommended intravenous ketamine infusions for treatment-resistant
depression. Per the psychiatrist, the ketamine infusions have improved the patients quality of
life and suicidal ideations. Currently, there is insufficient data on the long-term efficacy, safety,
and tolerability of intravenous ketamine for patients with treatment-resistant depression. The
U.S. Food and Drug Administration has approved Spravato (esketamine) nasal spray, in
conjunction with an oral antidepressant, for the treatment of depression in adults who have tried
other antidepressant medicines but have not benefited from them. Like intravenous ketamine,
esketamine nasal spray appears to have a robust and moderate effect on reducing symptoms of
depression. To date, there is a lack of high quality data comparing the efficacy of intranasal to
intravenous ketamine. Given this support, dosing with intravenous ketamine is not likely to be
more beneficial than standard of care. Therefore, ketamine infusions from 9/07/21 forward were
not and are not likely to be more beneficial than any available standard therapy.
| 1 |
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 1
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 Venclexta is not considered a standard of care for the treatment of patients with multiple myeloma. In addition, Venclexta is not U.S. Food and Drug Administration (FDA) approved for the treatment of multiple myeloma, supported major drug compenida, or the National Comprehensive Cancer Network (NCCN) guidelines. Venclexta has preliminary data from phase I trials showing it may only be efficacious for patients with certain genetic abnormalities and is the ongoing subject of clinical trials actively recruiting patients. Given the lack of data demonstrating improved patient health outcomes with use of Venclexta, the requested Venclexta (venetoclax) 100 mg, five tablets daily #150, is not 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 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 48-year-old male enrollee has requested reimbursement for CPT code 84999 performed on 1/31/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees melanoma.
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Upheld
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Medical Necessity
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Summary Reviewer
A 48-year-old male enrollee has requested reimbursement for CPT code 84999 performed on 1/31/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees melanoma. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. This patient had an early stage melanoma. The National Comprehensive Cancer Network guidelines state while there is interest in newer prognostic molecular techniques such as gene expression profiling to differentiate melanomas at low versus high risk for metastasis, routine prognostic genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study. The results of the services at issue were not likely to have altered treatment and surveillance recommendations. Thus, CPT code 84999 performed on 1/31/18 was not medically necessary for the evaluation of this patient. Therefore, the services at issue were not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
| 0 |
A 57-year-old female enrollee has requested authorization and coverage for Venclexta 100 mg, 240 for 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.
In this patients case, she is requesting this medication in combination with carfilzomib, which is the subject of actively recruiting clinical trials.
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Upheld
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Medical Necessity
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Summary Reviewer
A 57-year-old female enrollee has requested authorization and coverage for Venclexta 100 mg, 240 for 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 fails to demonstrate the medical necessity of the requested medication. Venclexta is U.S. Food and Drug Administration (FDA) approved for use in acute myeloid leukemia and chronic lymphocytic leukemia. It is not FDA approved for use in multiple myeloma or supported for off-label use in major drug compendia. Studies show promise, but these are phase I studies which show better efficacy in translocation t(11;14) and in combination with bortezomib and dexamethasone. In this patients case, she is requesting this medication in combination with carfilzomib, which is the subject of actively recruiting clinical trials. There is a lack of support for the requested medication in this clinical setting. Thus, Venclexta 100 mg tablets, 240 for 30 days are not medically necessary for the treatment of this patient.
| 1 |
A 59-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 8/30/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who presented for a breast examination.
In this particular patient, she has breasts containing multiple masses, many of which are changing in size.
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Overturned
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Experimental
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Summary Reviewer 3
A 59-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 8/30/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who presented for a breast examination. 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. In this particular patient, she has breasts containing multiple masses, many of which are changing in size. The ability of better characterizing the margins of masses and establishing whether there might be suggestion of malignancy is a valuable advantage of tomosynthesis over other methods of testing. The ability to separate out the overlapping structures enables the possibility of demonstrating an otherwise occult tumor. Had there been no interval change, a tomosynthesis would not be indicated but considering the changes, tomosynthesis, for this patient, is helpful. Therefore, digital breast tomosynthesis performed on 8/30/16 was likely to have been of greater benefit than other modalities for evaluating this patient. Based upon the information set forth above, the service at issue was 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 39-year-old male enrollee has requested authorization and coverage for corticotropin (H.P. Acthar Gel) injections, up to 40 units. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition.
The patient has features of various conditions. He has also not exhausted other treatment options,
This patient has already tried and failed two different steroids, including prednisone and
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Upheld
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Experimental
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Summary Reviewer 1
A 39-year-old male enrollee has requested authorization and coverage for corticotropin (H.P. Acthar Gel) injections, up to 40 units. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that the records fail to demonstrate the superior efficacy of the requested medication in this clinical setting. There is a lack of objective information, including physical examination, radiographs and confirmatory laboratory definitive studies, to establish a diagnosis of rheumatoid arthritis. The patient has features of various conditions. He has also not exhausted other treatment options, even if a diagnosis of rheumatoid arthritis has been established. The medical evidence supports the use of methotrexate or combination disease-modifying antirheumatic drug (DMARD) therapy, such as triple therapy with methotrexate, Plaquenil and sulfasalazine, unless contraindicated. A patient who fails DMARD therapy for rheumatoid arthritis is then a candidate for anti-tumor necrosis factor or other biologic therapies. This patient has already tried and failed two different steroids, including prednisone and Rayos. There is inadequate literature indicating that H.P. Acthar Gel is superior to these therapies in terms of efficacy or safety. Therefore, corticotropin (H.P. Acthar Gel) injections, up to 40 units is not likely to be more beneficial than other available treatment options.
| 1 |
A 43-year-old female enrollee has requested reimbursement for the breast tomosynthesis performed on 8/20/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
The patient did not have dense breasts, she did not have a mass, there were no palpable lumps, and she did not have suspicious calcifications.
Her breasts were described as being composed almost entirely of fat.
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Overturned
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Experimental
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Summary Reviewer 3
A 43-year-old female enrollee has requested reimbursement for the breast tomosynthesis performed on 8/20/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that Tomosynthesis is a technique that was developed 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. In this case, however, there were no problems to be resolved. The patient did not have dense breasts, she did not have a mass, there were no palpable lumps, and she did not have suspicious calcifications. In addition, there had been no change when the current study was compared to prior studies. Her breasts were described as being composed almost entirely of fat. Tomosynthesis has not been shown to provide significant increased value in patients who have diffusely fatty breasts. With diffusely fatty breasts, routine 2D mammography is highly accurate. As such, the breast tomosynthesis performed on 8/20/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available modalities. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 62-year-old male enrollee has requested reimbursement for genetic testing performed on
9/29/20. The Health Insurer has denied this request and reported that the services at issue were
investigational for the evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 3
A 62-year-old male enrollee has requested reimbursement for genetic testing performed on
9/29/20. The Health Insurer has denied this request and reported that the services at issue were
investigational for the evaluation of the enrollees medical condition. At issue is whether the
services at issue were likely to have been more beneficial for evaluation of the enrollee's condition
than any available standard therapy. The physician reviewer found that Decision Dx-SCC assay is
a 40-gene assay exploring the genomic make-up of cutaneous invasive squamous cell cancer. This
assay sorts the cancer into classes, each with a different rate of metastasis. The assay claims that
it can predict the potential for metastasis, thereby changing the clinical approach to surveillance.
At this time, however, it has not been shown to have a positive clinical impact above and beyond
evaluation of the specific pathologic details of the individual cancer. It is not included within the
National Comprehensive Cancer Network guidelines for squamous cell cancer. The medical
evidence has not demonstrated the superior efficacy of the services at issue. Therefore, the genetic
testing performed on 9/29/20 was not likely to have been more beneficial than any available
standard therapy.
| 0 |
A 37-year-old male enrollee has requested reimbursement for small bowel overgrowth test panel (CPT codes 82491 and 91065) performed on 11/16/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees medical condition.
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Overturned
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Medical Necessity
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Summary Reviewer
A 37-year-old male enrollee has requested reimbursement for small bowel overgrowth test panel (CPT codes 82491 and 91065) performed on 11/16/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees medical condition. The physician reviewer found the medical literature supports the services at issue for this clinical situation. The patient presented with bloating. Bloating can be a sign of small intestinal bacterial overgrowth (SIBO). Accurate and definitive diagnosis can be difficult (Ponziani, et al). However, hydrogen breath testing is the most widely used diagnostic test for SIBO (Lacy, et al). Testing for both hydrogen and methane increases the sensitivity of the breath test, and is a considerable improvement over hydrogen testing alone (Saad, et al; de Lacy Costello, et al). Antibiotics are necessary for treatment of SIBO. Confirmation of SIBO with breath testing avoids using empiric antibiotics for those patients who do not have SIBO, as in this case (Ponziani, et al). Therefore, for the reasons stated above, the small bowel overgrowth test panel (CPT codes 82491 and 91065) performed on 11/16/15 was medically necessary for evaluation of this patient. The Health Insurers denial should be overturned.
| 0 |
A 42-year-old female enrollee requested authorization and coverage for CPT 58674 (Acessa procedure - laparoscopic radiofrequency ablation). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.
that the patient is requesting a treatment for symptoms related to her fibroid uterus. She has heavy menstrual bleeding that has led to the need for treatment. The patient would like her fibroids treated with the Acessa procedure.
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Overturned
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Experimental
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Summary Reviewer 3
A 42-year-old female enrollee requested authorization and coverage for CPT 58674 (Acessa procedure - laparoscopic radiofrequency ablation). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that the patient is requesting a treatment for symptoms related to her fibroid uterus. She has heavy menstrual bleeding that has led to the need for treatment. The patient would like her fibroids treated with the Acessa procedure. Studies have supported the Acessa technique under certain clinical criteria for patient selection. One of the criterion is uterine size. The maximum allowable uterine size is 16 weeks gestational age. This patients uterus has several fibroids that measure 4.7 7.6 cm, thus meeting the size criteria. Another criterion is fibroid location. The fibroids are intramural, which falls within the procedure guidelines. The patient wishes to have a minimally invasive procedure to preserve fertility. It is likely that shrinking multiple fibroids will result in improvement in the patients pain and bleeding and improve her quality of life. Therefore, CPT 58674 (Acessa procedure - laparoscopic radiofrequency ablation) is likely to be more beneficial than any available standard therapy.
| 1 |
A 35-year-old male 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.
that the patient has obstructive sleep apnea and has no nasal obstruction. Drug-induced sleep endoscopy showed no concentric collapse at velum and primarily anterior posterior collapse. The patient has not been able to tolerate the CPAP device.
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Overturned
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Experimental
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Summary Reviewer 2
A 35-year-old male 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 the patient has obstructive sleep apnea and has no nasal obstruction. Drug-induced sleep endoscopy showed no concentric collapse at velum and primarily anterior posterior collapse. The patient has not been able to tolerate the CPAP device. The Inspire device has been approved by the FDA for the treatment of obstructive sleep apnea. At this point, the patient is a candidate for the Inspire device, given the intolerance to CPAP, anterior posterior collapse, no central apnea, and body mass index (BMI) and apnea-hypopnea index (AHI) within FDA criteria. All told, 64568 and 0466T are likely to be more beneficial than any available standard therapy.
| 1 |
A 37-year-old female enrollee has requested reimbursement for the Afirma thyroid fine needle aspiration (FNA) analysis provided on 1/15/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees pituitary tumor and elevated prolactin.
the patient was facing total thyroidectomy if malignancy was present and but only subtotal thyroidectomy if the lesion turned out to be benign. Hence, the sample was submitted to Veracyte for gene expression analysis.
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Overturned
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Experimental
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Summary Reviewer 3
A 37-year-old female enrollee has requested reimbursement for the Afirma thyroid fine needle aspiration (FNA) analysis provided on 1/15/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees pituitary tumor and elevated prolactin. The physician reviewer found that Thyroid nodules are commonly managed by diagnostic FNA to evaluate the cytopathology. In this case, the finding by this standard technique was atypia of undetermined significance (Baloch, et al). This diagnostic category creates a dilemma with regards to recommended surgery. In this case, the patient was facing total thyroidectomy if malignancy was present and but only subtotal thyroidectomy if the lesion turned out to be benign. Hence, the sample was submitted to Veracyte for gene expression analysis. The Afirma gene expression test conducted by Veracyte has demonstrated a very high negative predictive value for malignancy (Alexander, et al; Chudova, et al). All told, the current peer-reviewed medical literature supports the diagnostic utility of the Afirma thyroid FNA analysis provided on 1/15/15 as likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, I have determined the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
patient is a 12-year-old female presenting with class I malocclusion characterized by significant rotations of her anterior teeth. Photographs submitted show the patient to have mild to moderate crowding of her teeth with several teeth rotated causing an aesthetic compromise. The patient shows a class I malocclusion with no excessive overbite or overjet, mild
. The patients parent has requested authorization and coverage for orthodontic treatment. The Health Insurer has denied this request as not medically necessary.
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is a 12-year-old female presenting with class I malocclusion characterized by significant rotations of her anterior teeth. Photographs submitted show the patient to have mild to moderate crowding of her teeth with several teeth rotated causing an aesthetic compromise. The patient shows a class I malocclusion with no excessive overbite or overjet, mild to moderate crowding and rotation of the teeth producing scores below the required score of 26 or greater to be considered a handicapping malocclusion necessitating orthodontic treatment. The patients parent has requested authorization and coverage for orthodontic treatment. The Health Insurer has denied this request as not medically necessary. The physician reviewer found the review of the submitted documentation and relevant literature fails to demonstrate the medical necessity for the requested services. The patient shows a class I malocclusion with no excessive overbite or overjet, mild to moderate crowding and rotation of the teeth producing scores below the score of 26 or greater to be considered a handicapping malocclusion necessitating orthodontic treatment. The records submitted do not document a medical condition or significant impairment caused by the malocclusion. Based on the documentation submitted for review, the request for orthodontic treatment is not medically necessary for treatment of the patients medical condition. For the reasons provided, the requested services are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
patient is a 50-year-old male who underwent open reduction and internal fixation of a distal radius fracture of the left arm. Postoperatively, the provider prescribed an intermittent limb compression device for edema control.
this patient underwent open reduction and internal fixation of a fracture of the distal radius associated with edema. The provider prescribed intermittent limb compression for edema control.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 50-year-old male who underwent open reduction and internal fixation of a distal radius fracture of the left arm. Postoperatively, the provider prescribed an intermittent limb compression device for edema control. The physician reviewer found that this patient underwent open reduction and internal fixation of a fracture of the distal radius associated with edema. The provider prescribed intermittent limb compression for edema control. Although this device is commonly used for lymphedema control after breast cancer surgery, edema of the upper extremity from a comminuted fracture of the distal radius can also be controlled by this device. Several studies have indicated that this device is safe and effective for upper extremity edema control. It can be used at home as well after discharge from the hospital. Based upon the demonstrated safety and efficacy of this device, it was reasonable, appropriate and medically indicated for the treatment of this patientas left arm edema. Therefore, the intermittent limb compression device provided on 5/17/19 was medically necessary for the treatment of this patient.
| 1 |
A 59-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 9/26/16. 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
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Summary Reviewer 2
A 59-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 9/26/16. 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 there is sufficient support for the service at issue in this clinical setting. Per Skaane and colleagues, the use of mammography plus tomosynthesis in a screening environment resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers. Ciatto and colleagues noted integrated two-dimensional and three-dimensional mammography improves breast cancer detection and has the potential to reduce false positive recalls. In sum, breast tomosynthesis performed on 9/26/16 was likely to have been of greater benefit 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 parent of a three-year-old male enrollee has requested reimbursement for the FirstStepDx Plus testing performed on 12/14/15. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees autism spectrum disorder.
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Overturned
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Experimental
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Summary Reviewer 1
The parent of a three-year-old male enrollee has requested reimbursement for the FirstStepDx Plus testing performed on 12/14/15. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees autism spectrum disorder. The physician reviewer found that chromosome microarray is the standard of care for the evaluation of children diagnosed with ASD. The American College of Medical Genetics recommends CMA as an appropriate first-tier test for the evaluation of imbalances associated with intellectual disability, autism, and multiple congenital anomalies. The diagnosis of ASD should be done based on physical exam with a child and evaluation of behaviors. However, finding a genetic cause for the ASD requires further medical evaluation including the CMA. CMA can also provide information on other diagnoses including Angelman syndrome, Williams syndrome or 22q that may overlap with a diagnosis of ASD. Accordingly, the FirstStepDx Plus performed on 12/14/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 37-year-old female enrollee has requested reimbursement for the Afirma thyroid fine needle aspiration (FNA) analysis provided on 1/15/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees pituitary tumor and elevated prolactin.
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Overturned
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Experimental
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Summary Reviewer 2
A 37-year-old female enrollee has requested reimbursement for the Afirma thyroid fine needle aspiration (FNA) analysis provided on 1/15/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees pituitary tumor and elevated prolactin. The physician reviewer found that while a FNA biopsy of a suspicious thyroid nodule is typically an accurate means of assessing whether the nodule is benign or malignant, approximately 15% of FNA biopsy results are considered to be indeterminate (Alexander, et al). Until recently, the only way to establish whether the nodule was consistent with cancer was via surgical excision (Miller, et al). The Afirma thyroid FNA analysis from Veracyte utilizes a gene expression classifier in order to help determine the likelihood of malignancy of nodules with indeterminate cytology on FNA biopsy, thereby decreasing the need for unnecessary surgeries. Because the Afirma thyroid test is very sensitive and has a high negative predictive value, a negative result is suggestive of a benign nodule (Duick, et al). Given this support, the Afirma thyroid FNA analysis provided on 1/15/15 was likely to have been more beneficial for evaluation of this patients medical condition than any available standard therapy. Based upon the information set forth above, I have determined the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
The patient is a 42-year-old male with a history of relapsing-remitting multiple sclerosis (RRMS)
and optic atrophy. The provider has recommended treatment with Vumerity because it has the
same mechanism of action as dimethyl fumarate, but with fewer gastrointestinal side effects.
The Health Insurer has denied the requested medication as not medically necessary for
treatment of the patients medical condition.
. This patient has RRMS and is currently asymptomatic but has cervical spine
lesions on MRI. The records document that the patient has experienced good response with
dimethyl fumarate treatment but with adverse effects.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 42-year-old male with a history of relapsing-remitting multiple sclerosis (RRMS)
and optic atrophy. The provider has recommended treatment with Vumerity because it has the
same mechanism of action as dimethyl fumarate, but with fewer gastrointestinal side effects.
The Health Insurer has denied the requested medication as not medically necessary for
treatment of the patients medical condition. The physician reviewer found that for patients with
relapsing forms of multiple sclerosis (MS), disease-modifying therapies (DMTs) have shown
benefit in terms of reducing relapses. However, adherence to a DMT may be affected by adverse
effects (Rae-Grant, et al.). The U.S. Food and Drug Administration (FDA) has approved Vumerity
as a DMT for patients with relapsing forms of MS, including RRMS). Vumerity undergoes the same
mechanism of action as the delayed-release dimethyl fumarate (Naismith, et al.). The authors
found that Vumerity demonstrated an improved gastrointestinal tolerability compared with
dimethyl fumarate. This patient has RRMS and is currently asymptomatic but has cervical spine
lesions on MRI. The records document that the patient has experienced good response with
dimethyl fumarate treatment but with adverse effects. Given the similarity of Vumerity to
dimethyl fumarate with fewer reported gastrointestinal side effects, this medication is
appropriate for this patient. Therefore, the requested Vumerity 231 mg capsule is medically
necessary for the treatment of this patient.
| 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.
This patient has been diagnosed with progressive keratoconus. The records noted that the patients visual acuity had been decreasing to the point where it interfered with activities of daily living. Keratoconus
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Overturned
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Experimental
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Summary Reviewer 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. The physician reviewer found that there is sufficient support for the services at issue in this clinical setting. This patient has been diagnosed with progressive keratoconus. The records noted that the patients visual acuity had been decreasing to the point where it interfered with activities of daily living. Keratoconus is caused by a structural abnormality in the collagen of the cornea, wherein the cornea becomes progressively misshapen (astigmatic) over time. Eventually, this may develop into failure of the cornea, with intractable edema and permanent loss of vision. The classic treatment for keratoconus-induced visual decline is a corneal transplant. This procedure involves risk and the potential for significant complications. Corneal collagen crosslinking is considered to be part of the standard of care for patients with progressing keratoconus, and this involves less risk than corneal transplant. Therefore, corneal collagen crosslinking performed on 9/04/18 was likely to have been more effective than other treatment options.
| 1 |
A 61-year-old male enrollee has requested authorization and coverage for percutaneous transcatheter closure of the left atrial appendage with implant (Watchman device). The Health Insurer has denied this request indicating that the requested services are considered investigational for 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 male enrollee has requested authorization and coverage for percutaneous transcatheter closure of the left atrial appendage with implant (Watchman device). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The physician reviewer found the current medical evidence supports the requested services in this patients case. The Watchman device is non-inferior to warfarin treatment for long-term stroke prevention due to paroxysmal or persistent atrial fibrillation. Given this patients recent thromboembolic stroke and known history of paroxysmal fibrillation, as well as higher bleeding risk for systemic anticoagulation, he is an appropriate candidate for the requested services. Therefore, the requested percutaneous transcatheter closure of the left atrial appendage with implant (Watchman device) is likely to be of greater benefit than other treatment options. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 64-year-old female enrollee has requested reimbursement for genetic testing performed on 11/30/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who was diagnosed with breast cancer.
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Overturned
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Experimental
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Summary Reviewer 3
A 64-year-old female enrollee has requested reimbursement for genetic testing performed on 11/30/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who was diagnosed with breast cancer. The physician reviewer found that the OncotypeDX test is a gene expression assay that generates a DCIS score that may predict the occurrence of ipsilateral invasive breast cancer. The gene expression test was prospectively analyzed in clinical trial E5194, where 327 women with DCIS were stratified into low, intermediate, and high scores, which predicted for either DCIS recurrence or invasive breast cancer in the ipsilateral breast. The test may be used to better assess the utility of radiation therapy after a lumpectomy. The patient under discussion had a complex situation where normal pathology biomarkers were not well suited to address whether a lumpectomy and radiation therapy were appropriate therapies versus total mastectomy. In sum, the genetic testing performed on 11/30/16 was likely to have been more beneficial than the standard alternatives for evaluation of this patient. Therefore, for the reasons stated above, the services at issue were likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 59-year-old male enrollee has requested reimbursement for platelet-rich plasma injections provided from 7/14/17 forward. The Health Insurer has denied this request indicating that the services at issue were and are considered investigational for treatment of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 1
A 59-year-old male enrollee has requested reimbursement for platelet-rich plasma injections provided from 7/14/17 forward. The Health Insurer has denied this request indicating that the services at issue were and are considered investigational for treatment of the enrollees medical condition. The physician reviewer found that the intra-articular injections of platelet-rich plasma are known to be beneficial in patients with early osteoarthritis as well as advanced osteoarthritis of the knees and other joints. These injections are known to be more efficacious in the treatment of knee osteoarthritis in terms of pain relief and self-reported functional improvement at three, six and 12 months follow-up, compared with other injections such as corticosteroid injections. No harmful effects are reported from these injections. However, in this case, the medical records do not include sufficient clinical and radiographic information necessary to support the necessity of such treatment in the multiple joints that were injected. A detailed history and physical examination and imaging studies are generally necessary to make an accurate diagnosis and determine the necessity of invasive treatment. Official radiology reports indicating the presence of osteoarthritis necessitating such treatment have not been included. In the absence of such clinical and radiographic findings, platelet-rich plasma injections in various joints is not supported. Additionally, the documentation does not indicate a positive sacroiliac diagnostic block confirming the pain source. Ultrasound or fluoroscopic guidance is generally used for sacroiliac injections. However, there is no documentation of the same. With regard to the trapeziometacarpal joints of the thumbs, the literature suggests efficacy in early osteoarthritis, but not in advanced cases. As such, x-rays are necessary. All told, the superior efficacy of platelet-rich plasma injections provided from 7/14/17 forward has not been established. Based upon the information set forth above, the services at issue were not and are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 56-year-old female enrollee has requested reimbursement for the three-dimensional (3D) mammogram (breast tomosynthesis) provided on 1/9/17. The Health Insurer has denied this request indicating that the service at issue is considered investigational for evaluation of the enrollees risk of breast cancer.
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Overturned
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Experimental
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Summary Reviewer 1
A 56-year-old female enrollee has requested reimbursement for the three-dimensional (3D) mammogram (breast tomosynthesis) provided on 1/9/17. The Health Insurer has denied this request indicating that the service at issue is considered investigational for evaluation of the enrollees risk of breast cancer. The physician reviewer found that despite the lack of long-term studies proving an increased survival rate when tomosynthesis has been used as part of screening mammography the American College of Radiology (ACR) urged the technique be removed from the investigational category due to the advantage it brings radiologists interpreting mammograms. This tomographic method often allows the reader to separate dense glandular elements from underlying mass and architectural distortion resulting in a decrease in callbacks and increase in overall diagnostic accuracy compared to two-dimensional (2D) imaging alone. Thus, the addition of tomosynthesis to the usual 2D protocol was likely of greater benefit to the patient than had her mammogram been done with 2D imaging alone. As such, the 3D mammogram (breast tomosynthesis) provided on 1/9/17 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the 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 |
A 49-year-old male enrollee has requested authorization and coverage for percutaneous transcatheter closure of atrial septal defect. The Health Insurer has denied this request indicating that the requested services are considered 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 49-year-old male enrollee has requested authorization and coverage for percutaneous transcatheter closure of atrial septal defect. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The physician reviewer found the requested services are not likely to be more effective for this patient than other available options. Based on an assessment of the peer reviewed literature, the superior benefit of PFO closure versus medical therapy has not been established in cases such as in this clinical setting. The RESPECT trial did demonstrate superiority of PFO closure in patients assigned to the Amplatzer PFO occluder in comparison to guideline directed medical therapy with one or more antiplatelet agents or warfarin (Carroll, et al). However, no significant benefit in the primary intent to treat analysis was documented. In sum, the requested percutaneous transcatheter closure of atrial septal defect is not likely to be more beneficial for treatment of the patients medical condition than any other modalities.Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 59-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 9/26/16. 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
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Summary Reviewer 3
A 59-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 9/26/16. 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 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. The medical literature supports the service at issue in this patients case. The study by Mansour and colleagues demonstrated that screening sensitivity of full field digital mammography was increased from 60% to 94.5%, and specificity increased from 20.7% to 74% when digital breast tomosynthesis was applied. Operative bed recurrence could be more confidently excluded from scarring, which reduced the number of indeterminate findings. Digital breast tomosynthesis allowed unnecessary biopsy to be avoided in 37.3% of patients. Thus, breast tomosynthesis performed on 9/26/16 was likely to have been more effective than other modalities for 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 parent of a two-year-old male enrollee has requested reimbursement for FirstStepDX Plus chromosomal microarray analysis. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the patient is a two-year-old male who was born at 38 weeks gestation following a pregnancy significant for hyperemesis requiring frequent antiemetic therapy and preterm labor at 32 weeks gestation requiring modified bed rest. He suffered an event prior to discharge characterized by choking followed by desaturation to the 20s with subsequent resuscitation efforts. Persistent transaminitis lead to liver biopsy at eight weeks of age and a diagnosis of giant cell hepatitis. He had difficulties with feeding, colic, and delayed achievement of usual gross motor milestones. He currently receives physical therapy with ongoing gross motor delays. Neurologic examination in March 2015 revealed increased deep tendon reflexes in his lower extremities, intermittent exophoria bilaterally, moderately decreased tone globally, inability to stand unassisted, and microcephaly. At that time, chromosomal microarray testing and fragile X testing were performed. The Health Insurer has denied reimbursement for FirstStepDX Plus chromosomal microarray analysis. Per the Health Insurer, FirstStepDX Plus chromosomal microarray analysis was investigational for the evaluation of this patient.
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Overturned
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Experimental
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Summary Reviewer 2
The parent of a two-year-old male enrollee has requested reimbursement for FirstStepDX Plus chromosomal microarray analysis. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the patient is a two-year-old male who was born at 38 weeks gestation following a pregnancy significant for hyperemesis requiring frequent antiemetic therapy and preterm labor at 32 weeks gestation requiring modified bed rest. He suffered an event prior to discharge characterized by choking followed by desaturation to the 20s with subsequent resuscitation efforts. Persistent transaminitis lead to liver biopsy at eight weeks of age and a diagnosis of giant cell hepatitis. He had difficulties with feeding, colic, and delayed achievement of usual gross motor milestones. He currently receives physical therapy with ongoing gross motor delays. Neurologic examination in March 2015 revealed increased deep tendon reflexes in his lower extremities, intermittent exophoria bilaterally, moderately decreased tone globally, inability to stand unassisted, and microcephaly. At that time, chromosomal microarray testing and fragile X testing were performed. The Health Insurer has denied reimbursement for FirstStepDX Plus chromosomal microarray analysis. Per the Health Insurer, FirstStepDX Plus chromosomal microarray analysis was investigational for the evaluation of this patient. The current medical evidence supports the services at issue in this patients case. 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 (ASD). Use of buccal sampling is an acceptable means of obtaining material for study. According to the literature, when coupled with a chromosomal microarray that contains single nucleotide polymorphic probes, analysis of buccal cells can maximize a clinicians opportunity to detect cytogenetic mosaicism. Based on the literature and current standard of practice, the services at issue were likely to have been superior over other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 32-year-old transgender female enrollee has requested authorization and coverage for CPT codes 21137, 21209, 15824 and 15876. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition.
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Overturned
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Medical Necessity
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Summary Reviewer
A 32-year-old transgender female enrollee has requested authorization and coverage for CPT codes 21137, 21209, 15824 and 15876. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the current medical evidence supports the requested services in this clinical setting. The patient has been on hormone therapy. Ainsworth and Spiegel demonstrated that facial feminization surgery, like genital surgery, improved mental health-related quality of life. World Professional Association for Transgender Health (WPATH) states, Non-genital surgical procedures notably facial feminization surgeryare often of greater practical significance in the patients daily life than reconstruction of the genitalsThese reconstructive procedures are not optional in any meaningful sense, but are understood to be medically necessary for the treatment of the diagnosed condition. Therefore, CPT codes 21137, 21209, 15824 and 15876 are medically necessary for the treatment of this patient.
| 0 |
The patient is a 52-year-old male with a history of low back pain and left-sided sciatic pain for which he underwent L4-5 microdiscectomy on 2/7/15 with an initial good result. The patient sustained a fall in July 2015 and experienced recurrence of symptoms with low back and left radicular pain and numbness radiating posterolaterally to the left foot. Magnetic resonance imaging (MRI) scan demonstrated L4-5 grade 1 retrolisthesis with moderate left worse than right foraminal stenosis and L5-S1 disc protrusion with left foraminal stenosis and left L5 nerve root contact. He had a left L4-5 epidural steroid injection which gave him 100% relief for two days. He then had two injections on the left at L4-5 and one injection on the left at L5-S1, which gave him 50% relief. He does feel weakness of the left lower extremity and occasional unsteadiness with ambulation. Progress notes dated 7/13/16 document negative straight leg raising bilaterally. His gait was normal. His strength was 4+/5 in the left plantar flexors and hamstrings and decreased sensation to light touch over the left lateral thigh, lateral leg, medial and lateral foot. The patient has failed many months of conservative therapy including multiple injections, medications, and is currently on narcotic medications. The provider recommended surgery to include L4-5 and L5-S1 facetectomies on the left. Due to the decompression
cessitating a fusion from L4-S1. The provider is requesting anterior/posterior fusion from L4
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 52-year-old male with a history of low back pain and left-sided sciatic pain for which he underwent L4-5 microdiscectomy on 2/7/15 with an initial good result. The patient sustained a fall in July 2015 and experienced recurrence of symptoms with low back and left radicular pain and numbness radiating posterolaterally to the left foot. Magnetic resonance imaging (MRI) scan demonstrated L4-5 grade 1 retrolisthesis with moderate left worse than right foraminal stenosis and L5-S1 disc protrusion with left foraminal stenosis and left L5 nerve root contact. He had a left L4-5 epidural steroid injection which gave him 100% relief for two days. He then had two injections on the left at L4-5 and one injection on the left at L5-S1, which gave him 50% relief. He does feel weakness of the left lower extremity and occasional unsteadiness with ambulation. Progress notes dated 7/13/16 document negative straight leg raising bilaterally. His gait was normal. His strength was 4+/5 in the left plantar flexors and hamstrings and decreased sensation to light touch over the left lateral thigh, lateral leg, medial and lateral foot. The patient has failed many months of conservative therapy including multiple injections, medications, and is currently on narcotic medications. The provider recommended surgery to include L4-5 and L5-S1 facetectomies on the left. Due to the decompression with need for facetectomies, L4-5 spondylolisthesis instability would be created necessitating a fusion from L4-S1. The provider is requesting anterior/posterior fusion from L4-S1. The patient has requested authorization and coverage for lumbar fusion (22558, 20936, 22840, 22612, 22851, 63048, 20930, 22585, 22614, and 63042). The Health Insurer denied the request for surgery in the absence of documented instability, infection, tumor, or spinal stenosis. This denial is the subject of this appeal and determination. The medical literature supports the medical necessity for the requested services in this clinical setting. Yavin and colleagues summarized the current evidence on the comparative safety and efficacy of lumbar fusion, decompression-alone, or nonoperative care for degenerative indications. The authors reported that disability, pain, and patient satisfaction following fusion, decompression-alone, or nonoperative care were dependent on surgical indications and study methodology. Relative to decompression alone, the risk of reoperation following fusion was increased for spinal stenosis and decreased for spondylolisthesis. In this patients case, the fusion is being performed for iatrogenic instability that will be created upon decompression for degenerative spondylolisthesis and associated neural compression. The provider is planning two level facetectomies at L4-5 and L5-S1 on the left, which will necessitate a stabilization procedure. All told, the requested lumbar fusion (22558, 20936, 22840, 22612, 22851, 63048, 20930, 22585, 22614, and 63042) is supported as medically necessary for treatment of this patients medical condition. Therefore, for the reasons stated above, the requested services are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
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
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Summary Reviewer 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. The physician reviewer found the medical literature supports the service at issue in this patients case. Skaane and colleagues noted the use of mammography plus tomosynthesis in a screening environment resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers. Ciatto and colleagues noted that integrated two-dimensional and three-dimensional mammography improves breast cancer detection and has the potential to reduce false positive recalls. In sum, three-dimensional mammogram performed on 10/31/16 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 |
A 50-year-old female enrollee has requested reimbursement for CPT code 81479 (unlisted molecular pathology, Cxbladder) performed on 12/19/18. 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 50-year-old female enrollee has requested reimbursement for CPT code 81479 (unlisted molecular pathology, Cxbladder) performed on 12/19/18. 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 medical evidence does not support the services at issue in this clinical setting. Cxbladder testing has a beneficial role in the diagnostic work-up of gross or microscopic hematuria when standard evaluation results in equivocal or conflicting information from cystoscopy and imaging studies. In this patients case, the records documented a normal cystoscopy and normal computed tomography (CT) urogram which would not benefit statistically from Cxbladder testing based on the literature and current practice guidelines. Thus, CPT code 81479 (unlisted molecular pathology, Cxbladder) performed on 12/19/18 was not likely to have been more beneficial than other methods of evaluating this patient.
| 0 |
A 37-year-old female enrollee has requested reimbursement for gene testing performed on 1/19/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.T
This patient had this nodule for several years and patient was reluctant to incur in the risk of surgery.
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Overturned
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Experimental
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Summary Reviewer 3
A 37-year-old female enrollee has requested reimbursement for gene testing performed on 1/19/15. 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 pathology report was consistent with a follicular lesion of undetermined significance. This patient had this nodule for several years and patient was reluctant to incur in the risk of surgery. Per the medical records, the size of nodule, age and gender increased the patients risk for malignancy. Afirma testing was a valuable tool in this case. It made the recommendation and decision to remove the tumor more certain. Therefore, gene testing performed on 1/19/15 was likely to have been superior over other available modalities for evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
The patient is a five-year-old male who was admitted for hospitalization for diagnostic evaluation
and management of the abrupt onset of uncontrolled myoclonic seizures and ataxia. The patients
parent has requested reimbursement for an inpatient stay from 3/2/22 through 3/5/22. The Health
Insurer has denied this request and reported that the services at issue were not medically necessary
for the treatment of this patient.
. In this
case, the patient had an abrupt onset of uncontrolled mixed seizures, with generalized tonic-clonic
seizures and frequent myoclonic seizures. The patients seizures were frequent and uncontrolled
despite his being on an Keppra, an anticonvulsant. The records noted that at times the patient had
multiple myoclonic seizures while on video EEG telemetry. He had
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a five-year-old male who was admitted for hospitalization for diagnostic evaluation
and management of the abrupt onset of uncontrolled myoclonic seizures and ataxia. The patients
parent has requested reimbursement for an inpatient stay from 3/2/22 through 3/5/22. The Health
Insurer has denied this request and reported that the services at issue were not medically necessary
for the treatment of this patient. This denial is the subject of this appeal and determination. The
physician reviewer found that the submitted documentation supports the medical necessity of the
services at issue. Alix and colleagues note that useful clinical information is obtained in most
children in whom events are captured on video EEG telemetry. The onset of myoclonic seizures
in children places them at risk of significant risk of serious injury as the seizures may occur without
warning and frequently cause the child to fall. The differential diagnosis for myoclonic epilepsy
in children is broad, ranging from myoclonic-astatic epilepsy to a number of genetic forms of
progressive myoclonic epilepsy, some of which are eventually fatal. Myoclonic epilepsy can be
very difficult to control, often requiring high doses of medication, introduction of the ketogenic
diet, and occasionally the implantation of the vagus nerve stimulator or corpus callosotomy. In this
case, the patient had an abrupt onset of uncontrolled mixed seizures, with generalized tonic-clonic
seizures and frequent myoclonic seizures. The patients seizures were frequent and uncontrolled
despite his being on an Keppra, an anticonvulsant. The records noted that at times the patient had
multiple myoclonic seizures while on video EEG telemetry. He had also an abrupt onset of ataxia,
which appeared to have been related to starting Keppra. In this clinical setting, given that an
inpatient diagnostic workup including a spinal tap, MRI of the brain, and video EEG telemetry to
capture the seizure type for differential diagnosis, allow assessment of true seizure frequency, and
assess response to treatment was required, the services at issue were medically indicated.
Therefore, an inpatient stay from 3/2/22 through 3/5/22 was medically necessary for the treatment
of this patient.
| 1 |
A 31-year-old female enrollee has requested authorization and coverage for exome sequence analysis (gene panel testing). The Health Insurer has denied this request indicating that the requested services are considered investigational for evaluation of the enrollees medical condition.T
has had a lifelong neurologic disorder without specific diagnosis and has been termed cerebral palsy, but has atypical features including episodic hypotonia, and no history of birth anoxia.
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Upheld
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Experimental
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Summary Reviewer 3
A 31-year-old female enrollee has requested authorization and coverage for exome sequence analysis (gene panel testing). The Health Insurer has denied this request indicating that the requested services are considered investigational for evaluation of the enrollees medical condition.The physician reviewer found that patient has had a lifelong neurologic disorder without specific diagnosis and has been termed cerebral palsy, but has atypical features including episodic hypotonia, and no history of birth anoxia. Clinical neurogenetic assessment has raised the possibility of an undiagnosed genetic disorder, for which there could be prognostic and clinical value in making a more precise diagnosis. The medical evidence supports consideration of whole exome sequencing in the clinical diagnostic assessment of a phenotypically affected individual when the phenotype or family history data strongly implicate a genetic etiology, but the phenotype does not correspond with a specific disorder for which a genetic test targeting a specific gene is available on a clinical basis. This patient has a phenotype that may have a genetic basis, for which specific diagnosis could yield prognostic or therapeutic advantages. Therefore, the requested exome sequence analysis (gene panel testing) is likely to be more efficacious than other modalities for evaluating this patient. Based upon the information set forth above, the requested services are 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 46-year-old female enrollee has requested reimbursement for continuous positive airway pressure (CPAP) device provided on 1/3/18. The Health Insurer has denied this request indicating that the device at issue was not medically necessary for treatment of the enrollees obstructive sleep apnea.
In this case, the medical records provided demonstrate that the patient was diagnosed with OSA, was titrated on CPAP, and prescribed a CPAP for home use.
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Overturned
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Medical Necessity
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Summary Reviewer
A 46-year-old female enrollee has requested reimbursement for continuous positive airway pressure (CPAP) device provided on 1/3/18. The Health Insurer has denied this request indicating that the device at issue was not medically necessary for treatment of the enrollees obstructive sleep apnea. The physician reviewer found that current practice guidelines from the American Academy of Sleep Medicine (AASM) noted that OSA be treated as a chronic disease. In addition, Epstein and colleagues recommended that all patients with OSA should have ongoing, long-term management for their disorder. Patients on chronic therapy such as CPAP should have regular, ongoing follow-up to monitor adherence to therapy, side effects, development of medical complications related to OSA, and continued resolution of symptoms. In this case, the medical records provided demonstrate that the patient was diagnosed with OSA, was titrated on CPAP, and prescribed a CPAP for home use. Based on the current guidelines, CPAP is recommended as the first-line treatment for use in OSA. In this clinical setting, the CPAP device provided on 1/3/18 was medically necessary for treatment of this patients OSA. Based on the forgoing discussion, the device at issue was medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 52-year-old female enrollee has requested reimbursement for BCR-ABL gene rearrangement
quantitative polymerase chain reaction (PCR) testing, BCR-ABL fluorescent in situ hybridization
(FISH) performed on 11/21/22.
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Upheld
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Experimental
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Summary Reviewer 1
A 52-year-old female enrollee has requested reimbursement for BCR-ABL gene rearrangement
quantitative polymerase chain reaction (PCR) testing, BCR-ABL fluorescent in situ hybridization
(FISH) performed on 11/21/22. The physician reviewer found that Myeloproliferative syndromes
are clonal disorders that present as chronic myeloid leukemia (CML), chronic myelomonocytic
leukemia (CMML), polycythemia vera, or essential thrombocythemia, or primary myelofibrosis.
CMML has both myelodysplastic and myeloproliferative features but can also present with high
monocyte counts (Orazi and Germing; Emanuel). CML is defined by the presence of the BCR-ABL
rearrangement, whereas CMML has been associated with a distinct set of tyrosine kinase gene
rearrangements and point mutations. This patients records document high monocyte counts in
October 2022, which supports an indication for the BCR-ABL PCR and FISH testing performed in
this patients case. All told, the BCR-ABL gene rearrangement quantitative PCR testing, BCR-ABL
FISH performed on 11/21/22 was likely to be more beneficial for treatment of the patients
medical condition than any available standard therapy.
| 1 |
The parent of a six-year-old male enrollee has requested reimbursement and prospective authorization and coverage for 30 hours per week of applied behavioral analysis (ABA) therapy provided from 10/3/15 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees autism spectrum disorder (ASD).
In this case, the patient has made slow, but steady improvements with ABA at 30 hours per week. He still has significant maladaptive behaviors specifically aggression and self-injury.
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Overturned
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Medical Necessity
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Summary Reviewer
The parent of a six-year-old male enrollee has requested reimbursement and prospective authorization and coverage for 30 hours per week of applied behavioral analysis (ABA) therapy provided from 10/3/15 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees autism spectrum disorder (ASD). The physician reviewer found the review of the submitted documentation and relevant literature demonstrates the medical necessity of the services at issue. There is support in the medical literature demonstrating that ABA is effective for reducing aggression and self-injury. Mohammadzaheri and colleagues examined the use of ABA and pivotal response treatment in school age children with autism and disruptive behavior. The authors found these interventions to be very effective in decreasing maladaptive and disruptive behaviors even in school age children. In this case, the patient has made slow, but steady improvements with ABA at 30 hours per week. He still has significant maladaptive behaviors specifically aggression and self-injury. There is no evidence that his behavior is at a point that a reduction in ABA is indicated. Based on the support in the peer-reviewed literature, the request for 30 hours per week of ABA was and is medically necessary for treatment of the patients medical condition. Therefore, the services at issue were and are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 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 patient presented
with complaints of cough, shortness of breath and malaise.
the patient had typical symptoms of an upper respiratory tract infection. The patients vital
signs were stable and the initial treatment included a nebulized breathing treatment that was
effective to alleviate symptoms. The patient was also provided a diagnostic work-up which
indicated a normal white blood cell (WBC) count and a normal chest x-ray.
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Upheld
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Experimental
|
Summary Reviewer 3 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 viral
pathogens are often the most common cause of respiratory infections which include
rhinoviruses, respiratory syncytial virus, influenza virus, parainfluenza virus, adenovirus and
coronaviruses. A review of the standard of care indicates that treatment is generally supportive
and symptomatic. Further, antibiotics are rarely utilized, and antiviral treatment is recommended
only for patients with symptoms who are at high risk for complications. A review of medical
literature indicates that identifying the specific viral cause of an upper respiratory infection is not
likely to change the approach to treatment. Several standard methods available for diagnosis
include molecular methods, rapid tests, and microbiologic culturing. Influenza-specific assays
may be indicated for patients presenting with fever and flu-like syndrome. Otherwise, viral
polymerase chain reaction testing is generally not indicated. In this case, the patient presented
with complaints of cough, shortness of breath and malaise. A review of the record establishes
that the patient had typical symptoms of an upper respiratory tract infection. The patients vital
signs were stable and the initial treatment included a nebulized breathing treatment that was
effective to alleviate symptoms. The patient was also provided a diagnostic work-up which
indicated a normal white blood cell (WBC) count and a normal chest x-ray. Overall, the respiratory
viral panel testing was not expected to change the patients plan of care more than standard
testing. 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 |
A 66-year-old male enrollee has requested reimbursement for the unlisted chemistry procedure (84999) Prometheus Anser testing performed on 12/22/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Crohns disease.
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Upheld
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Experimental
|
Summary Reviewer 1
A 66-year-old male enrollee has requested reimbursement for the unlisted chemistry procedure (84999) Prometheus Anser testing performed on 12/22/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found the concept of following drug levels when using tumor necrosis factor (TNF)-alpha antibodies to provide personalized dosing has been around for many years. Following drug levels can keep a patient at a target level which translates into a higher probability of clinical benefit. This concept is based primarily on retrospective data which has demonstrated that, in general, higher trough levels correlate directly, and the presence of antibody correlates indirectly, with clinical efficacy. Knowledge of the drug and antibody level would therefore assist the provider in the decision to increase a drugs dose or perhaps switch to another class of biologics. However, this approach has not been shown to be superior to making empiric changes. There is a lack of controlled data which have identified the optimal drug level. A recent trial demonstrated this approach had no impact on clinical efficacy compared to empiric dose titration (Steenholdt, et al). Therefore, the unlisted chemistry procedure (84999) Prometheus Anser testing performed on 12/22/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
A 53-year-old female enrollee has requested authorization and coverage for vascularized lymph node transfer (VLNT). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.
|
Overturned
|
Experimental
|
Summary Reviewer 2
A 53-year-old female enrollee has requested authorization and coverage for vascularized lymph node transfer (VLNT). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The physician reviewer found the requested procedure is a sophisticated vascularized flap transfer and lymphaticovenous anastomoses with a microsurgical technique. The results documented in the medical literature show a statistically significantly improved functional outcome as a result of the procedure. Moreover, this procedure is specialized and cannot be recommended as routine treatment for all patients. The requested procedure is indicated for well-selected patients, such as in this patient with documented severe lymphedema. In addition, VLNT is likely to yield significant benefits for this patient. Therefore, in this clinical setting VLNT 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 55-year-old male enrollee has requested authorization and coverage for the LINX lower esophageal sphincter augmentation device. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD).
|
Overturned
|
Experimental
|
Summary Reviewer 1
A 55-year-old male enrollee has requested authorization and coverage for the LINX lower esophageal sphincter augmentation device. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD). The physician reviewer found that in 2013, the U.S. Federal Drug Administration (FDA) approved the LINX Reflux Management System for lower esophageal sphincter augmentation. Eligible patients for the procedure include those with inadequate symptom control with acid suppression therapy, including those patients with mild to moderate GERD, and a hiatal hernia less than 3 cm. This patient meets these specific criteria. Based upon a prospective study that included 44 patients, the mean total percent time pH less than 4 was reduced from 11.9% at baseline to 3.8% at three years (Lipham, et al). A recent study comparing the LINX procedure with laparoscopic fundoplication found that GERD patients had similar control of reflux symptoms after both LINX and fundoplication. The authors noted that the inabilities to belch and vomit were significantly fewer with LINX, along with a significantly lower incidence of severe gas-bloat symptoms (Reynolds, et al). Finally, five-year cohort data was published establishing the durability of the device. In a group of 85 patients, augmentation of the lower esophageal sphincter with a magnetic device provided significant and sustained control of reflux, with minimal side effects or complications. No new safety risks emerged over a five-year follow-up period (Ganz, et al). All told, the requested LINX lower esophageal sphincter augmentation device 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 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 |
The patient is a 28-year-old female who presented to her provider on 11/4/22. The patient has
requested authorization and coverage for omalizumab (Xolair) 150 mg. The Health Insurer has
denied this request and reported that the requested medication is not medically necessary for the
treatment of this patient.
this case, the records documented a serum Ig E level of 384.1 IU/mL on
10/26/22, along with positive serum allergen specific IgE levels for dust mite, mold, and pollens.
The patient has continued to experience persistent asthma symptoms such as dyspnea despite
combination therapy of inhaled corticosteroids and a long-
|
Overturned
|
Medical Necessity
|
Summary Reviewer
The patient is a 28-year-old female who presented to her provider on 11/4/22. The patient has
requested authorization and coverage for omalizumab (Xolair) 150 mg. The Health Insurer has
denied this request and reported that the requested medication is not medically necessary for the
treatment of this patient. This denial is the subject of this appeal and determination. The physician
reviewer found that the submitted documentation supports the medical necessity of the requested
medication. Xolair is a biologic therapy that targets specific inflammatory pathways involved in
the pathogenesis of asthma, particularly in patients with an endotype driven by type 2
inflammation. This targeted therapy has been shown to reduce asthma exacerbations, improve lung
function, reduce oral corticosteroid use, and improve quality of life in appropriately selected
patients. The U.S. Food and Drug Administration (FDA) approves the use of omalizumab for
patients with moderate-to-severe asthma over age six, with a positive skin test or in vitro reactivity
to at least one perennial allergen, and with symptoms that are inadequately controlled with inhaled
corticosteroids. In this case, the records documented a serum Ig E level of 384.1 IU/mL on
10/26/22, along with positive serum allergen specific IgE levels for dust mite, mold, and pollens.
The patient has continued to experience persistent asthma symptoms such as dyspnea despite
combination therapy of inhaled corticosteroids and a long-acting bronchodilator. Given that
current medical literature supports the use of the requested medication for patients with
uncontrolled allergic asthma symptoms in this clinical setting, the requested medication is
medically indicated. Therefore, omalizumab (Xolair) 150 mg is medically necessary for the
treatment of this patient.
| 1 |
A 60-year-old male enrollee has requested authorization and coverage for magnetic resonance imaging (MRI) scan of the shoulder. The Health Insurer has denied this request indicating that the requested services are not medically necessary for the evaluation of the enrollees shoulder pain.
|
Upheld
|
Medical Necessity
|
Summary Reviewer
A 60-year-old male enrollee has requested authorization and coverage for magnetic resonance imaging (MRI) scan of the shoulder. The Health Insurer has denied this request indicating that the requested services are not medically necessary for the evaluation of the enrollees shoulder pain. The physician reviewer found that the submitted documentation does not support the medical necessity of the requested services in this clinical setting. The American College of Radiology (ACR) has established appropriateness criteria to evaluate various clinical presentations. The ACR recommends obtaining plain x-rays as a first line evaluation of shoulder pain. The next study recommended is MRI. However, in this patients case, MRI is not medically indicated at this time. It is unclear how recent the trauma occurred and it would be expected that an MRI might show changes of wear and tear. Similarly, in a study by Schwartzberg and colleagues, they found a high rate of superior glenoid labral tear diagnoses based on MRI in a cohort of middle-aged, asymptomatic people. The study indicated that rotator cuff tears or labral tears are common, especially in the elderly, and that it is important to remember that their presence does not always impute pain or clinically significant loss of function. This study reaffirms that magnetic resonance findings are not necessarily an explanation for the patients symptoms. In this patients case, he has not undergone a trial of intensive conservative management. Three months of conservative treatment with persistence of symptoms is not unreasonable. All told, MRI of the shoulder is not medically necessary for the evaluation of this patient. Therefore, for the reasons stated above, the requested services are not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 21-year-old female enrollee has requested authorization and coverage for Octagam infusions. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrolleeas medical condition.
Fifteen patients were given a trial of immune modulatory therapy with IVIG and/or steroids, and 12 patients (80%)
|
Upheld
|
Experimental
|
Summary Reviewer 2
A 21-year-old female enrollee has requested authorization and coverage for Octagam infusions. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that Dysautonomia is an umbrella term referring to any disorder associated with dysfunction of the autonomic nervous system. There are many different mechanisms by which dysautonomia may arise, but there has been increasing evidence and awareness that it may be immune-mediated in some patients. Autoimmune autonomic dysfunction may be peripheral due to an immune-mediated small fiber polyneuropathy (SFPN) and may manifest clinically as postural tachycardia syndrome, orthostatic intolerance, orthostatic hypotension, inappropriate sinus tachycardia, gastrointestinal dysmotility, complex regional pain syndrome, and/or neurogenic bladder. Intravenous immunoglobulin (IVIG) is a first-line treatment for immune-mediated neuropathies such as Guillain-Barre syndrome, chronic inflammatory demyelinating polyneuropathy, and multifocal motor neuropathy. Oaklander and Klein reported on the efficacy of immune modulatory therapy in children with SFPN. Fifteen patients were given a trial of immune modulatory therapy with IVIG and/or steroids, and 12 patients (80%) demonstrated improvement. A retrospective analysis by Schofield and Chemali studied the efficacy and safety of IVIG in patients with disabling, refractory autoimmune dysautonomias, including patients with postural tachycardia syndrome and gastrointestinal dysmotility. There were 38 patients, and 83.5% improved on IVIG as defined by at least 20% improvement in the composite autonomic symptom scale 31 and/or functional ability score. The authors concluded, aThere is increasing evidence that IVIG is safe and effective in a subset of patients with autonomic disorders and evidence for autoimmunity. A four-month IVIG trial should be considered in severely affected patients who are refractory to lifestyle and pharmacological therapies.a In this case, the patient has an underlying autonomic nervous system dysfunction on multiple medications. Based on the studies noted above, patients with dysautonomia may improve clinically with intravenous immunoglobulin treatment. Therefore, Octagam infusions are likely to be more beneficial than any available standard therapy.
| 1 |
The parent of a 16-year-old female enrollee has requested reimbursement for mental health residential treatment provided from 11/07/18 through 11/15/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions.
that the patient was not actively suicidal but did report she was passively suicidal on one occasion.
The patient has had some issues with level of function due to mental illness and relational issues but overall showed appropriate daily functioning while in treatment.
The patient was noted to have a good relationship with her family.
The patient had a good response to a short period in the residential treatment center with minimal continued signs or symptoms of anxiety and depression. She was participating in therapy while on the unit and was not displaying serious or disruptive symptoms.
|
Upheld
|
Medical Necessity
|
Summary Reviewer
The parent of a 16-year-old female enrollee has requested reimbursement for mental health residential treatment provided from 11/07/18 through 11/15/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found that in cases such as this, an evidence-based instrument such as American Academy of Child and Adolescent Psychiatry and the American Association of Community Psychiatrists Child and Adolescent Level of Care Utilization System (CALOCUS) assists in determining the necessary level of care for children. With regards to risk of harm, the records support a score of 2. The documentation indicates that the patient was not actively suicidal but did report she was passively suicidal on one occasion. In terms of functional status, the records support a score of 2. The patient has had some issues with level of function due to mental illness and relational issues but overall showed appropriate daily functioning while in treatment. In terms of comorbidity, the records support a score of 1. The patient did not have a history of past medical issues or substance use. With regards to level of stress of the recovery environment, the records support a score of 2. The patient was noted to have a good relationship with her family. In terms of level of support of the recovery environment, the records support a score of 2. The patients parents are involved in treatment. With regards to resiliency and treatment history, the records support a score of 3. The patient had a good response to a short period in the residential treatment center with minimal continued signs or symptoms of anxiety and depression. She was participating in therapy while on the unit and was not displaying serious or disruptive symptoms. In terms of acceptance and engagement of the patient, the records support a score of 2. The records documented that the patient participated in therapy. With regards to acceptance and engagement of the parent, the records support a score of 2. The patients parents worked actively and constructively with clinicians on a regular basis. Thus, the patient has a composite score of 16. This score correlates with intensive outpatient services. Therefore, mental health residential treatment provided from 11/07/18 through 11/15/18 was not medically necessary for the treatment of this patient.
| 1 |
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