Persius/hicric huggingface dataset:
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Transient Ischemic Attack

Treatment: Inpatient Admission

The insurer denied the Inpatient Admission. The denial was upheld. 

This is an elderly male who presented to the emergency department in mid-2019 with complaints of dizziness.  It is reported that the patient's daughter stated that while the patient was eating breakfast, he was feeling dizzy and lightheaded as if he was going to pass out. She stated that he appeared pale, diaphoretic, and had a slurred speech for 5 to 10 minutes during the described episode. It was noted that upon arrival the patient had no further complaints and was feeling better. He had a history of hyperlipidemia and hypertension. His physical examination revealed he was alert and oriented, and was able to follow commands, but was having difficulty speaking. The patient's laboratory studies revealed no significant abnormalities.  A Computer Axial Tomogram scan of the brain was performed which did not reveal any acute intracranial hemorrhage or acute appearing territorial infarction. He had a chest x-ray that showed mild air trapping without focal lobar lung consolidation. The patient was admitted and received intravenous fluids. Physical therapy evaluated the patient and noted that the patient was feeling better and denied any further complaints of dizziness. He was discharged home with physical therapy and home health care in place. 

According to referenced literature a patient may be admitted to inpatient services when there is evidence of acute bacterial labyrinthitis, cerebellar, brainstem, or cerebral ischemia or hemorrhage, hemodynamic instability, severe persistent vomiting, and severe new neurologic findings requiring inpatient services or evidence of cardiac arrhythmias of immediate concern.  Within the documentation none the above was present.  It was noted the patient presented with complaints of dizziness prior to presentation however, upon presentation the symptoms resolved.  

Based on the above, the medical necessity for the inpatient admission is not substantiated.  The insurer's denial is upheld.
Appeal type: Medical necessity
Decision: Upheld

The patient is a gravida (G) 0 female who is under care for dysmenorrhea. She was prescribed Lo Loestrin for oral contraceptive care by her gynecology provider. The patient reported that she has tried alternative therapies for contraceptive care and dysmenorrhea but has fallen ill for extended periods with these medications. The patient is noted to have no significant medical history. Her weight is 122 lbs. with a body mass index (BMI) of 19 kilograms per square meter (kg/m2). She was provided samples of Lo Loestrin Fe at her last visit. She had a normal exam. The subject under review is the medical necessity for Lo Loestrin oral contraceptive for the indication of dysmenorrhea.

Based upon a review of the medical records, correspondence from the patient and plan, and consideration of the peer reviewed medical literature, there is no medical necessity for Lo Loestrin for this patient. In this case, the patient is noted to have dysmenorrhea. This is effectively treated with oral contraceptive pills in most cases.
The patient has to try at least three plan-preferred medications and fail these prior to a finding of medical necessity is affirmed for a non-preferred agent (in this case Lo Loestrin oral contraceptives). The preferred agents include the following: Alesse-28, Aviane, Apri, Balziva, Cryselle, Estrostep Fe, Junel (FE), Portia, Reclipsen, Lo/Ovral, Ortho-Cept, Loestrin (FE) 1.5/30, Loestrin (FE) 1/20, Nordette, Ortho-Novum 1/35, Ortho-Novum 7/7/7, Ortho-Cyclen, Ortho-Tri-Cyclen, Ovcon 50, Trivora, Zenchent, Zovia 1/35, Zovia 1/50, generic Seasonale, Ortho Evra, and Nuvaring. There is no documentation that the patient has tried and failed any of these. Thus, there has been no failure of the preferred formulary alternatives in this case. There is no medical evidence that Lo Loestrin is superior in management of contraceptive care or dysmenorrhea. Thus, this agent would not be considered superior in the management of these health conditions. The requested Lo Loestrin would not be medically necessary for this patient.
Appeal type: Experimental/Investigational
Decision: Upheld

This is a male patient who presented to an orthopedist with complaints of right knee pain.  The patient had an x-ray of his right knee that showed significant narrowing of the medial compartment approaching bone-on-bone contact.  There are mild arthritic changes at the patella-femoral compartment.  Lateral compartment is well-preserved.  No fractures or bony lesions were noted.  It was reported that the patient had difficulty kneeling and squatting and was positive for a Bakers' Cyst.  The patient had been treated with anti-inflammatories, but could no longer tolerate due to kidney function.  He was treated with prednisone and tramadol, along with the use of a brace and crutches. The patient underwent a computer navigated right total knee arthroplasty. 

According to Jones, C. W., & Jerabek, S. A. (2018), "A review of the current literature demonstrates that there are enough well-designed studies to conclude that both large-console CAS and handheld navigation systems improve the accuracy and precision of component alignment in TKA.  However, missing from the evidence base, other than the subgroup analysis provided by the Australian Orthopaedic Association National Joint Replacement Registry, are any conclusive demonstrations of a clinical superiority in terms of improved patient-reported outcome measures and/or decreased cumulative revision rates in the long term." 

Based on the scientific evidence in peer reviewed literature provided, a result of improvement in health outcome is not supported with computer-assisted surgical navigational procedure.  Literature is not supportive or conclusive in the use of computer-assisted surgical navigational procedure.  This patient is not a good candidate for Computer-assisted surgical navigational procedure for musculoskeletal procedures, image-less.  Literature does not support that computer-assisted surgical navigational procedure is the best available treatment.  Further studies are needed.     

The carrier's denial of 20985-Computer-assisted surgical navigational procedure for musculoskeletal procedures, image-less should be upheld.
Appeal type: Experimental/Investigational
Decision: Upheld

This is a male patient who presented to an orthopedist with complaints of increased right knee pain.  An x-ray of the right knee revealed severe osteoarthritis.  It was reported that the patient uses a knee brace and ambulates with crutches.  The patient had been treated with anti-inflammatories, steroids and tramadol. The patient underwent a computer navigated right total knee arthroplasty. 

Regarding use of computer-assisted surgical navigation, medical literature has shown that improvement in prosthesis alignment occurs with navigated total knee arthroplasty; however, there remains a lack of high quality long-term studies that have demonstrated that this correlates with improved clinical outcomes, such as improved function and lower revision rates.

The carrier's denial of 20985-Computer-assisted surgical navigational procedure for musculoskeletal procedures, image-less should be upheld.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis:  Total Right Knee Replacement
 
Treatment:  Computer-assisted surgical navigational procedure

The insurer denied the Computer-assisted surgical navigational procedure.  The denial was upheld.   

This is a male patient who consulted an orthopedist for complaints of right knee pain.  It was reported that the patient had a history of severe osteoarthritis.  The patient underwent a right total knee replacement with computerized navigation. 
It has approval by FDA for marketing but there are no recommendations or comments regarding benefit.  There is no indication or condition reported which would benefit from use. Problems with limb size and deformity can distort anatomy.  Addition of computer navigation may assist in performing the procedure.  The records denote no deformity, elevated BMI or limb problem to require computer navigation.  A standard total knee arthroplasty is the "gold standard" in the management of osteoarthritis.  There are no guidelines or recommendations made by National Organization to substantiate its use. 

The use of the computer navigation is not likely to be more beneficial than any standard procedure. 

The carrier's denial of 20985-Computer-assisted surgical navigational procedure for musculoskeletal procedures, image-less should be upheld.
Appeal type: Medical necessity
Decision: Upheld

This is a patient with no significant medical history who presented to the emergency department by ambulance after his finger was closed in a door.  An x-ray in the ED revealed a nondisplaced fracture involving the distal aspect of the 4th middle phalanx.  The area was noted to have swelling and a laceration on exam, and plastic surgery was consulted.  He was taken to surgery and underwent replacement of the nail plate beneath the eponychial fold and a closed reduction and splinting of the fracture.  The health plan's determination is upheld.  This child had an open finger fracture.  According to the records, he was admitted for IV antibiotics, but treatment with IV antibiotics for minimally contaminated wounds is not supported by the medical literature.  According to a recent systematic literature review, antibiotics administered in the ED was sufficient to prevent infection following open hand fractures.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Thoughts of suicide 
Treatment: Continued inpatient admission 

The continued inpatient admission was not medically necessary. (Please see below.)

On the first day under review, the patient was calm and sociable with peers. She denied auditory and visual hallucinations as well as suicidal ideation. She tolerated her medications without difficulties. The next day, the patient showed no signs of behavioral problems. She denied suicidal ideation and hallucinations. She attended group therapy, participated in unit activities, and was encouraged to verbalize her feelings and thoughts. The next day she was calm, interactive, and respectful, but superficial and avoidant of problematic issues.

Nothing in the documentation provided suggests that this patient, with a history of revolving door admissions and outpatient noncompliance, could benefit from continued inpatient care once the acute crisis was over. By first day under review the patient was calm, cooperative, in good behavioral control, and showed no evidence of danger to self or others. Treatment could have continued safely and effectively at a less intensive level of care from that date forward.
Appeal type: Medical necessity
Decision: Upheld

The patient has a history of hypertension (HTN) and tobacco abuse and presented to emergency department (ED) with intermittent chest pain that started 4-5 days prior to presentation.  The pain progressively worsened over 5 days especially in the last 24 hours.  He had to sleep on two pillows.  The patient's pain worsened in supine position.  The pain had a dull character, and it was 9-10 in intensity.  The patient was given nonsteroidal anti-inflammatory drug (NSAID) in the ED.  The patient was admitted to the hospital. 

The health plan's determination is upheld.  The inpatient stay was not medically necessary.  This patient presented with chest pain.  He was diagnosed with pericarditis based on character of his chest pain and presence of pericardial effusion.  His condition was stable; he did not have evidence of hemodynamic compromise; there was no evidence of cardiac tamponade, and the patient responded well to Ibuprofen.  His work up for aortic dissection, pulmonary emboli and acute coronary syndrome was negative.  His work up for etiology of pericarditis also was negative.  Based on above, the patient did not meet criteria for inpatient admission and could have been treated at a lower level of care.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Wheezing
Issue under review: Inpatient admission

Determination:
The Inpatient admission was medically necessary.

Although the patient does not meet initial criteria for IV treatment and admission for a more serious lung disease, such as pneumonia given by the Infectious Diseases Society of America (1), she nonetheless needed be admitted. Given her history of severe COPD requiring nine intubations, recent pneumothorax, and her inability to care for herself (homelessness, substance abuse, and trying to elope), trying to treat this patient as an outpatient would have been contrary to the standard of care. Specifically, given her history, she had a high likelihood of a serious complication (respiratory failure, intubation, or death) if she were to have been discharged. Standard of care would require admission and close observation (even a 1:1 sitter as was done in this case).
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Impacted permanent anteriors
 
Treatment: Braces and monthly visits

The insurer denied the braces and monthly visits. The denial was reversed.

This patient presented for evaluation for orthodontic care. The orthodontist recommended comprehensive orthodontics due to Class III malocclusion, severe maxillary and mandibular crowding, and impacted maxillary canines. The orthodontist completed the Handicapping Labio-Lingual Deviation (HLD) index as required and has chosen the automatically qualifying condition of impacted permanent anteriors where extraction is not indicated. 

It is evident that the patient exhibits a significant malocclusion.  However, to assess for severity of the malocclusion and therefore medical/dental necessity for orthodontic care, New York State requires the Handicapping Labio-Lingual Deviation Index Report. This index provides six specific conditions that automatically qualify for orthodontic care.  Additional criteria are used utilizing a point system if none of these initial qualifying conditions are met or selected.  For these other secondary criteria to qualify for orthodontic care, a total score of 26 points is necessary. 

In this case, the treating orthodontist claims an automatic qualifying condition of impacted permanent anteriors where extraction is not indicated. This reviewer finds that this automatically qualifying condition criterion is met and does support comprehensive orthodontic care. The clinical circumstance meets criteria to justify orthodontic care.

The Handicapping Labiolingual Index has been shown through scientific scrutiny in peer reviewed journals to be a valid and reliable determinant of need for orthodontic care.  As this is an accepted methodology, this has been determined to represent an appropriate approach for assessing orthodontic need.  

Based on the above, the medical necessity for D8080 braces and D8670 monthly visits is substantiated.  The insurer's denial is reversed.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Malocclusion 

Treatment: Braces

The insurer denied coverage for Braces. The denial was upheld.

This patient is a male who presented for evaluation for orthodontic care.  The orthodontist has recommended orthodontics due to apparent relapse as the patient had orthodontics in the past and also recommends treatment due to prior history of trauma to the anterior maxillary teeth.  The orthodontist has completed the HLD index attaining 10 total points to support orthodontic care. 

The insurer denied coverage for orthodontic treatment as not medically necessary as the clinical circumstance does not meet the required handicapping malocclusion medical necessity requirements having attained a score of 10 points on the HLD index and further there is no documentation of a preexisting condition or congenital issue that would render orthodontics necessary.  

It appears that the patient exhibits a malocclusion.  However, to assess for severity of the malocclusion and therefore medical/dental necessity for orthodontic care, an orthodontic Index, the Handicapping Labio-Lingual Deviation Index Report is utilized.  This index provides six specific conditions that automatically qualify for orthodontic care.  Additional criteria are used utilizing a point system if none of these initial qualifying conditions are met or selected.  For these other secondary criteria to qualify for orthodontic care a total score of 26 points is necessary. 

Regarding the validity of the Handicapping Labiolingual Index, it has been shown through scientific scrutiny in peer reviewed journals that this methodology for assessing orthodontic need is a valid approach.  This is confirmed by several studies. Each of these peer reviewed articles concludes that this index is a valid and reliable determinant of need for orthodontic care.  As this is an accepted methodology, this has been determined to represent an appropriate approach for assessing orthodontic need.  

In this case, the treating orthodontist does not claim an automatic qualifying condition and (based on the insurer documentation) completed the second portion of the index arriving at 10 points to justify orthodontic care.  This is below the threshold of 26 points to support orthodontic care.  Based on the information provided, this reviewer would concur with an HLD index of 10 points, although this is difficult to truly assess based on incomplete documentation. Of note in this case, the patient's own orthodontist does not attain 26 points on the HLD index as required for orthodontic approval.  Further, the documentation provided by the doctors is inadequate and history of trauma is not an indication for orthodontic care in this circumstance.

The carrier's denial of coverage for full braces is upheld.  The medical necessity is not substantiated.
Appeal type: Experimental/Investigational
Decision: Upheld

Reviewer #3:

This is a female with node negative ER+ HER 2 negative breast cancer.  Prosigna Breast Cancer Prognostic Gene Signature Assay was performed and is under review.

The peer reviewed scientific literature does not support a result of improvement in health outcome for the Prosigna gene testing. The test is FDA approved; however, the Prosigna Breast Cancer Gene Assay does not have valid positive outcome data and is not recommended by the NCCN Guidelines.  The patient is not a good candidate for the gene assay.

The NCCN (2019) states referring to the Oncotype Dx multigene test: "The NCCN Panel members acknowledge that many assays have been clinically validated for prediction of prognosis.  However, based on the currently available data, the panel believes that the 21-gene assay has been best validated for its use as a prognostic test as well as in predicting who is most likely to respond to systemic chemotherapy."     

According to Losk, K., Freedman, R. A., Lin, N. U., et al. (2017), "Wait times in the treatment of breast cancer have increased over the past 20 years, in part as a result of the growing complexity of breast cancer management, including additional testing conducted to help guide treatment decisions. Among patients with early-stage estrogen receptor (ER) positive and human epidermal growth factor receptor 2 (HER2) negative breast cancer, the Oncotype DX Recurrence Score (RS; Genomic Health, Redwood City, CA), a multigene diagnostic test that provides 10-year estimates for risk of breast cancer recurrence and the potential benefit of chemotherapy, is used by oncologists to assist in adjuvant treatment decisions and is included in all major breast cancer clinical guidelines."     
  
The Prosigna gene assay is not likely to be more beneficial than any of the standard treatments for breast cancer (such as Oncotype DX).  The carrier's denial of coverage for the Prosigna Breast Cancer Prognostic Gene Assay should be upheld.
Appeal type: Experimental/Investigational
Decision: Upheld

Reviewer #2:

This is a female who had bilateral lumpectomies. A Prosigna Breast Cancer Prognostic Gene Assay marker panel was sent. 

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome. Jensen et al. (2018) states, "The Prosigna risk of recurrence [ROR] score was not significantly predictive of treatment effect in a population combining ER+/- and HER2+/- patients.  

The NCCN (2019) states: "The NCCN Panel members acknowledge that many assays have been clinically validated for prediction of prognosis.  However, based on the currently available data, the panel believes that the 21-gene assay has been best validated for its use as a prognostic test as well as in predicting who is most likely to respond to systemic chemotherapy."     

The Prosigna Breast Cancer Prognostic Gene Assay is not the best available treatment for this patient at this time.  Prosigna only has a moderate recommendation and does not test for the same ER and HER2.

 Vieira, A. F., & Schmitt, F. (2018) state: "ASCO guidelines indicate that the clinician may use this signature "in conjunction with other clinicopathologic variables to guide decisions on adjuvant systemic therapy in ER/PgR-positive, HER2-negative, node-negative breast cancer: chemotherapy should be considered for patients in the PAM50 high-risk group and it is not indicated for patients in the low-risk group." Additional studies are needed to support recommendations about adjuvant chemotherapy in patients with an intermediate Prosigna/PAM50 ROR score.  Regarding node positive ER/PgR-positive, HER2-negative breast cancer, ASCO warns that "more data are required to determine whether PAM50-ROR can be used with confidence in guiding the use of adjuvant systemic therapy." Further, no data support the use of PAM50-ROR in HER2-positive breast cancer or in triple negative breast cancer."     

Based on the literature, the requested service is not likely to be more beneficial than any of the standard treatments/procedures for this patient. The carrier's denial of coverage for the Prosigna Breast Cancer Prognostic Gene Assay should be upheld.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Breast cancer

Treatment:  Prosigna Breast Cancer Prognostic Gene Assay

The insurer denied coverage for the Prosigna Breast Cancer Prognostic Gene Assay. The denial was upheld as three out of three panelists determined the treatment is not likely to be more beneficial than any of the standard treatments/procedures for this patient.

Reviewer #1:

This case involves a female diagnosed with malignant neoplasm of the upper-inner quadrant of the breast.  The patient underwent bilateral breast lumpectomies and was ER positive, PR positive, HER 2 IHC equivocal and HER 2 FISH negative.  The patient underwent Prosigna Breast Cancer Prognostic Gene Assay.

The medical literature notes that multigene assays provide prognostic and therapy -predictive information that complements Tn, N, M and biomarker information. Use of these assays is not required for staging.  The 21-gene assay (Oncotype Dx) is preferred by the National Comprehensive Cancer Network (NCCN) Breast Cancer Panel for node negative breast cancer.  Other prognostic multigene assays can provide additional prognostic information in patients with 1-3 positive lymph nodes, but are unknown if predictive of chemotherapy benefit.  The documentation indicated the patient had a diagnosis of malignant neoplasm of the upper inner quadrant of the breast.  The patient had ER positive, PR positive, HER 2 IHC equivocal and HER 2 FISH negative cancer.  However, the requested testing is not the standard of care.  The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome.  The testing does have final approval from the appropriate regulatory bodies.  However, the patient is not a good candidate for the requested Prosigna gene assay and it is not the best available treatment for the patient at this time.  Additionally, it is not likely to be more beneficial than any standard treatments/procedures for the patient.

The carrier's denial of coverage for the Prosigna Breast Cancer Prognostic Gene Assay should be upheld.