Persius/imr-appeals huggingface dataset:
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 


A 61-year-old male enrollee has requested authorization and coverage for 100 mcg 15 fentanyl patches per month and 10 mg methadone. The Health Insurer has denied this request indicating that the requested medication dosages are not medically necessary for treatment of the enrollees chronic pain. The physician reviewer found that the dose escalation is not a long term plan but a short term plan for the treatment of tolerance. The stepwise World Health Organization (WHO) ladder for pain relief is considered the reasonable approach to pain control in the palliative setting. However, in this case, there is no medical evidence based rationale given for the increase in dosage by the provider. Not all non-opioid treatment options have been utilized. The records do not mention the completion of behavior therapy despite much research to support its use. In addition, the medical literature indicates that in this clinical setting, it is also reasonable to consider alternatives to opioids and to wean the patient to a lower dose of opioids or even off opioids. Furthermore, no objective treatment goals for pain and function are noted for the requested medication. Also, several requirements for opioid prescribing have not been documented and the need to use them as the primary medication treatment strategy for pain has not been established. The Centers for Disease Control and Prevention (CDC) states that when starting opioid therapy for chronic pain, clinicians should prescribe immediate release opioids instead of extended release/long acting (ER/LA) opioids. The CDC also states when opioids are started, clinicians should prescribe the lowest effective dosage. Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when considering increasing dosage to = 50 morphine milligram equivalents (MME)/day, and should avoid increasing dosage to = 90 MME/day or carefully justify a decision to titrate dosage to = 90 MME/day. In this case, the patient was recently taking 840 MME/day. No medical evidence based rationale is given by the provider or the patient, for the long term consequences with the continual increase in opioids. Risk and benefit analysis must be performed to justify the requested level of 840 MME/day. The submitted documentation is unclear as to what the plan is for any unseen future pain insults the patient would experience while on 840 MME/day. Dose escalation is not a long term plan. The provider has not provided clear objective goals with this high of a dose for these requested medications.  As noted above, not all non-opioid medications classes have been optimized or tried. For all these reasons, 100 mcg 15 fentanyl patches per month and 10 mg methadone are not medically necessary for treatment of the patients medical condition. Therefore, for the reasons stated above, the requested medication dosages are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 


A 26-year-old female enrollee has requested reimbursement for services performed on 2/01/16 and 4/13/16 (CPT 81406 and 81415).  The Health Insurer has denied this request and reported that the services at issue were not medically necessary for evaluation of the enrollees medical condition. The physician reviewer found that gene panels and whole exome sequencing (which both use next generation sequencing technology) for the investigation of medical complaints is a well-established clinical paradigm.  When a specific clinical diagnosis is strongly suspected, single gene testing may be appropriate.  When a category of disorder is suspected, a panel of genes that covers conditions resembling the patients presentation is appropriate.  Klein and Foroud have shown that the diagnostic yield is superior for gene panels than for single gene tests.  When no particular disorder is suggested by the patients presentation, whole exome sequencing is an appropriate next step. Information is accumulating that shows a diagnosis is made more expediently using newer genetic technologies such as exome sequencing rather than embarking upon a diagnostic odyssey that includes invasive procedures.  Recent literature shows that for neurometabolic disorders in particular, the yield of exome sequencing is high and changes clinical management in nearly half of patients.  All told, services performed on 2/01/16 and 4/13/16 (CPT 81406 and 81415) were medically indicated for the treatment of this patient.  Therefore, the services at issue were medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2

A 56-year-old male enrollee has requested reimbursement for an endoskeletal left transtibial prosthesis provided on 1/03/19. The Health Insurer has denied this request and reported that the device at issue was investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that in lower limb loss rehabilitation, the prosthetic ankle-foot mechanism is the most common major component needed to restore function. All individuals that undergo a lower limb amputation at or proximal to the ankle joint will require a prosthetic ankle-foot mechanism to walk with minimal gait deviations and have stability and proper alignment of knees, hips and spine. Evidence-based clinical practice guidelines state that patient age or amputation etiology is not the primary consideration in prosthetic foot type selection. Evaluation of functional status and mobility needs of the patient is crucial to determine what type of prosthetic foot is needed. There are five categories of K3-level prosthetic ankle-foot mechanisms currently available. The categories include microprocessor ankle-foot (MPF) mechanisms and four that are classified as non-microprocessor. The MPF utilizes a microprocessor and series of sensors to measure the patientas gait cycle and then respond according to the required output for optimal stepping With the exception of two currently available commercial MPF, these feet are primarily adaptive in nature, using small motors to adjust hydraulic or pneumatic resistance to forces but do not generate power at the ankle. MPF allows greater mobility than the other four available types since it is the only one that utilizes sensors to read and subsequent motors to respond to various tasks faced by the user, given it is the most analogous function to the human neuromuscular system. The evidence-based clinical guidelines inform decision making in determining the most appropriate prosthetic foot type for individuals with lower-limb amputation in consideration of their clinical presentation. This patient in this case has experienced major lower-limb amputation (i.e., ankle-disarticulation level or proximal), has experienced adequate healing at the primary wound site to permit prosthetic fitting, and has the demonstrated ability to ambulate with a prosthesis. Current high-quality research supports the use of endoskeletal transtibial prosthesis in this case. All told, endoskeletal left transtibial prosthesis provided on 1/03/19 was likely to have been more beneficial than other available treatment options.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 


A 55-year-old female enrollee has requested reimbursement for cervical spine surgery performed on 7/25/17. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees neck pain and tingling in the upper extremities.The physician reviewer found there is sufficient support for the services at issue in this clinical setting. Davis and colleagues performed a prospective, randomized, controlled, multicenter clinical trial on two-level symptomatic degenerative disc disease. Their findings supported the use of cervical arthroplasty at two contiguous levels and demonstrated advantages over two-level anterior cervical discectomy and fusion. The U.S. Food and Drug Administration has approved the use of artificial disc replacement for skeletally mature patients for reconstruction of the disc from C3-C7 following discectomy at two contiguous levels for intractable radiculopathy (arm pain and/or neurologic deficit) with or without neck pain, or myelopathy due to abnormality localized to the level of the disc space and at least one of the following conditions confirmed by radiographic imaging: herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes) and/or visible loss of disc height compared with adjacent levels. This patient presented with persistent and worsening neck pain radiating down the left upper extremity, with tingling and weakness, and progressive right upper extremity symptoms. Associated symptoms included clumsiness and inability to grasp and hold objects. She was no longer able to work. Clinical examination findings evidenced C6 and C7 myotomal weakness consistent with imaging evidence of nerve root compromise at the C5-C6 level and bilateral neural foraminal stenosis at the C6-C7 level. Detailed evidence of long-term reasonable and/or comprehensive nonoperative treatment protocol trial and failure has been submitted. Evidence-based criteria were met to establish the medical necessity of this surgical intervention. Therefore, the cervical spine surgery performed on 7/25/17 was medically necessary for the treatment of this patient. Therefore, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

A 30-year-old female enrollee has requested reimbursement for laboratory services (82784, 83718, 85652, 84480, 84479, 84478, 82607, 36425, 86705, 85025, 86665, 86665. 86664, 83540, 83550, 86803, 86645, 80053, 86790, 86790, 86663, 82306, 84481, 84443, 86039, 86038, 82465, 86644, 82728, 82746, 87340, 86709, 82784, 82784, 80061, 80074 and 80050) provided on 8/16/17. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that code 83718 represents a test for lipoproteins and was not medically necessary because there was no evidence of a lipid-related disease. Code 84478 represents a measurement of triglycerides and was not medically necessary because there was no evidence of a lipid-related disease. Code 86705 represents hepatitis B core antibody and was not medically necessary because other hepatitis B screening was also done. Code 85025 represents a complete blood count and was not medically necessary because the same test was apparently coded as 80050. Code 86803 represents a test for hepatitis C and was not medically necessary because a screening test for all three types of viral hepatitis had also been done. Code 86663 represents an Epstein-Barr virus antibody and was not medically necessary because Epstein-Barr virus does not cause chronic fatigue. Code 87340 represents a test for hepatitis B surface antibody and was not medically necessary because a screening test for this infection was also ordered. Code 86709 represents a test for hepatitis A antibody and was not medically necessary because a screening test for this infection was also ordered.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 


A 64-year-old male enrollee has requested authorization and coverage for Xiaflex (clostridial collagenase histolyticum) injection. The Health Insurer has denied this request indicating that the requested therapy is not medically necessary for treatment of the enrollees Peyronies disease.The physician reviewer found that Peyronies disease is caused by scar tissue, called plaque, which forms along the length of the penis in the corpora cavernosa. This plaque is not visible, and depending on the severity of the condition, this condition can cause penile curvature with erection. The curvature can make intercourse difficult and/or painful for the patient and his partner. Potential treatments for Peyronies disease include surgery, minimally invasive treatment options, and medication. The results of most available medications have been inconsistent or lacked empirical support for effectiveness; however, Xiaflex injections have the potential to significantly reduce penile curvature in this setting. CCh (Xiaflex) is a purified mixture of AUX-I and II collagenases. Medical studies have shown this therapy to be a minimally invasive treatment for Peyronies disease. Findings from IMPRESS (Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) I and II, 2 independent, double-blind, placebo controlled studies, reveal the efficacy and tolerability of CCh for improving the physical and psychological outcomes of Peyronies disease. The two studies examined collagenase injections in 832 patients with moderate to severe curvature from Peyronies disease. Patients treated with collagenase injections had 34% improvement in penile curvature compared to 18% in the placebo group (Gelbard et al).  A follow-up open label study who received placebo also showed good outcomes with this therapy (Levine et al). American Urological Associations Peyronies disease guidelines from 2015 state: Clinicians may administer intralesional collagenase clostridium histolyticum in combination with modeling by the clinician and by the patient for the reduction of penile curvature in patients with stable Peyronies disease, penile curvature >30 and <90, and intact erectile function (with or without the use of medications). (Moderate Recommendation; Evidence Strength Grade B). Furthermore, EAU guidelines consider intralesional collagenase one of the recommended treatments for non-operative treatment of Peyronies disease. Moreover, intralesional injection therapy with CCH has been approved by the Food and Drug Administration (FDA) for the treatment of adult men with Peyronies disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. In this patients case, the submitted documentation demonstrates that he is an appropriate candidate for Xiaflex and therefore Xiaflex is medically necessary for treatment of his medical condition. Based on the reasons stated above, the requested therapy is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2 
 
A 55-year-old male insured has requested authorization and coverage for thermal destruction of 
the intraosseous basivertebral nerve, including the first two vertebral bodies, lumbar or sacral, 
Intracept procedure (CPT 64628). The Health Insurer has denied this request indicating that the 
requested services are considered investigational for the treatment of the insureds chronic back 
pain.  The  physician  reviewer  found  that  the  Intracept  procedure  is  a  minimally  invasive 
outpatient procedure allowing for quick recovery and is implant-free. This patients provider has 
recommended treatment with the Intracept procedure to address a history of severe chronic low 
back pain that has persisted for over six months. In this case, the patient experienced relief from 
the majority of his pain with a hip bursa injection. Although the patients MRI does show Modic 
endplate changes, it is most likely that the patients pain generator lies away from the L5-S1 disc 
space. Overall, there is a lack of support in the peer-reviewed medical literature or guidelines to 
support the long-term safety and efficacy of the Intracept procedure in this patients clinical 
setting (Fischgrund, et al.; Truumees, et al.). All told, the requested thermal destruction of the 
intraosseous basivertebral nerve, including the first two vertebral bodies, lumbar or sacral, 
Intracept procedure (CPT 64628) is not likely to be more beneficial for the treatment of the 
patients medical condition than any available standard therapy.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer  
 
The patient is a 74-year-old male who has been diagnosed with ulcerative colitis. The patient has 
requested authorization and coverage for Lialda. The physician reviewer found that the current 
medical evidence supports the requested medication in this clinical setting. Mesalamine has 
proven effective for the treatment of ulcerative colitis in randomized, double-blind, multicenter 
trials, although various formulations result in release at distinct times and locations in the 
gastrointestinal tract, making them clinically different from each other. Specifically, Lialda is 
different from mesalamine and 5-aminosalicylate alternatives such as sulfasalazine, balsalazide, 
Asacol, Salofalk, Mezavant XL, and Pentasa, and their respective generic formulations, each with 
release in different portions of the gastrointestinal tract and at different pH levels. The result of 
changing therapy can be inadequate control by a different formulation which directs the drug to 
a different part of the gastrointestinal tract. Additionally, ulcerative colitis flares can be induced 
by salicylate medications, and changing therapy can expose the patient to this risk. The request 
for Lialda is supported as medically necessary for the treatment of this patients ulcerative colitis 
as the patient is stabilized on Lialda, and a change could potentially cause a destabilization. 
Therefore, Lialda is medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3

A 49-year-old female enrollee has requested reimbursement for Tempus xT gene panel performed on 3/16/20.  The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that this patient has advanced ovarian cancer. She has been appropriately treated with debulking surgery and multi-agent chemotherapy. Close follow-up has revealed progressive disease. According to the National Comprehensive Cancer Network guidelines and the National Cancer Institute Physicians Data Query, it will be important to know the presence of germline or somatic mutations in BRCA1 and/or BRCA2. She may be offered certain therapies based upon mutation status. The patient may also be eligible for clinical trials based on her mutational status. It is notable that the National Comprehensive Cancer Network guidelines support testing for BRCA1 or BRCA2 mutations as well as other assays that might evaluate for homologous recombination defects. The National Comprehensive Cancer Network noted that pathologic assessment should include tumor molecular analyses as clinically indicated. Per the National Comprehensive Cancer Network guidelines, this includes next generation sequencing for BRCA1/2 mutations, other somatic mutations (e.g., NTRK gene fusions), and tumor mutational burden. These assessments were part of the ordered laboratory test. Therefore, the Tempus xT gene panel performed on 3/16/20 was likely to have been more beneficial than any available standard therapy.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3

The patient is a 58-year-old male with history of left-sided invasive breast cancer, clinically staged as cT2N1M1, stage IV, estrogen receptor (ER) positive, progesterone receptor (PR) positive, and grade III. The patient is noted to have a single osseous metastasis in the pelvis located in the right acetabulum. The provider noted this is a case of oligometastatic breast cancer. The patient has been treated with neoadjuvant chemotherapy followed by mastectomy and sentinel lymph node biopsy, revealing good treatment response. Given the low disease burden on computed tomography (CT), the provider has recommended treatment with stereotactic body radiotherapy (SBRT). The patient has requested authorization and coverage for SBRT. The Health Insurer has denied this request indicating that the requested services are considered investigational. SBRT is a treatment that couples a high degree of anatomic targeting accuracy and reproducibility with very high doses of precise, externally generated, ionizing radiation, thereby maximizing the cell-killing effect on the target(s) while minimizing radiation-related injury in adjacent normal tissues. This patient has breast cancer that was treated aggressively and has responded nicely. He has single metastatic lesion in acetabulum which needs aggressive treatment for durable local control. The current literature has demonstrated that aggressive treatment of limited metastases improves local control and slows progression beyond that expected with standard radiation therapy. All told, the requested SBRT 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.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1

A 56-year-old female enrollee has requested reimbursement for the hip surgery (CPT codes 29914 and 29915) provided on 6/17/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees right hip impingement syndrome. The physician reviewer found that surgical treatment of symptomatic femoroacetabular impingement aims to improve symptoms, potentially delay hip osteoarthritis, and prevent the need for a possible total hip arthroplasty. Hip arthroscopy and open surgical hip dislocations are the two most common surgical approaches used for this condition. The arthroscopic procedure avoids some of the complications of open surgery and results in over 75% positive results. Femoroacetabular impingement may be of the cam or pincer-type or it may be mixed. In this patients case, the femoroacetabular impingement was mixed, degenerative changes were mild, and conservative treatment failed to improve her condition, thus surgery was recommended. The patient met the surgical criteria for the procedure which included correction of the cam and pincer as well as repair of the labrum. Based upon a review of the medical records including the magnetic resonance imaging (MRI) scan and operative report, the hip surgery (CPT codes 29914 and 29915) provided on 6/17/16 was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.