Persius/hicric huggingface dataset:
Appeal type: Experimental/Investigational
Decision: Overturned

Reviewer #2:

Diagnosis: Lung cancer

Treatment: CPT (Current procedural terminology) code 0242U

The insurer denied coverage for CPT code 0242U

The denial is overturned

This case involves an adult diagnosed with malignant neoplasm of the lower lobe of the left lung and atrial fibrillation who was being recommended for targeted genomic sequence analysis panel, solid organ neoplasm, cell free circulating deoxyribonucleic acid (DNA) analysis of 55-74 genes, interrogation for sequence variants gene copy number amplification and gene rearrangements. The lab report using Guardant360 CDx testing noted abnormalities. The patient was subsequently diagnosed with malignant neoplasm of the lower lobe of the left lung with metastases to the brain. She began receiving paclitaxel and carboplatin. In addition, she received stereotactic radiation therapy and chemotherapy.  

An appeal was submitted stating that Guardant360 companion diagnostic (CDx) was approved by the Food and Drug Administration (FDA) and was released commercially. The report went on to state that Guardant360 CDx is designed and intended for use in all solid tumor cancers for molecular profiling to determine the appropriate therapies for patients. To minimize wasting of tissue, the National Comprehensive Cancer Network (NCCN) panel recommends that biomarker testing be done as part of broad molecular profiling using a validated test(s) that assesses a minimum of the following potential genetic alterations. Additionally, the test is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for cancer patients with solid malignant neoplasms.  

The scientific evidence in peer-reviewed literature supports a result of improvement in health outcome.

Current procedural terminology (CPT) code 0242U has final approval from the appropriate regulatory bodies for this diagnosis.

This patient is a good candidate for CPT code 0242U and it is one of the best available treatments for this patient at this time.

The adverse risks are not increased over standard treatments/services.

Based upon the provided information, the requested service is likely to be at least as beneficial if not more beneficial than any of the standard treatments/procedures for this patient.  Given the provided information within the NCCN guidelines from this year along with current peer-reviewed medical literature, it was determined that the proposed testing would be appropriate for this patient.

In summary, the denial of  CPT code 0242U (Targeted genomic sequence analysis panel, solid organ neoplasm, cell-free circulating DNA analysis of 55-74 genes, interrogation for sequence variants gene copy number amplification and gene rearrangements) and coverage for the requested service should be overturned.  

This treatment is likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are not substantially increased over standard treatments.
Appeal type: Experimental/Investigational
Decision: Overturned

Reviewer #1:

Diagnosis: Lung cancer

Treatment: CPT (Current procedural terminology) code 0242U

The insurer denied coverage for CPT (Current procedural terminology) code 0242U

The denial is overturned

This case involves an adult under review for molecular testing. Laboratory reported Guardant360 CDx testing revealed that alteration/biomarkers were detected. Clinical reported the patient presented with left lung cancer. It was noted that work-up revealed brain metastasis.  The patient was undergoing stereotactic radiation therapy and chemotherapy. Appeal letter reported Guardant360 CDx was Food and Drug Administration (FDA) approved. It was noted that the test was designed and intended for use in all solid tumor cancers for molecular profiling to determine the appropriate therapies for patients. Letter stated that testing was supported by National Comprehensive Cancer Network (NCCN) and peer-reviewed literature.  Determination letter reported prior denial was upheld as it was not demonstrated through prevailing peer-reviewed medical literature that testing was safe and effective for treating or diagnosing the condition or illness for which it was proposed.

NCCN states that "In the initial diagnostic setting, if following pathologic confirmation of a Non-small cell lung cancer (NSCLC) diagnosis there is insufficient material for molecular analysis, cell-free/circulating tumor DNA should be used". In this case, the patient had a history of lung cancer with initial biopsy revealing moderately differentiated adenocarcinoma with necrosis and lung parenchyma. There is also evidence of brain metastasis. Further molecular testing would be appropriate given diagnosis. Testing would affect treatment plan. This testing is given support by guidelines and literature.

The scientific evidence in peer-reviewed literature does support a result of improvement in health outcome. Current procedural terminology (CPT) code 0242U does have final approval from the appropriate regulatory bodies for this diagnosis. This patient a good candidate for CPT code 0242U and it is the best available treatment for this patient at this time. The adverse risks are not increased over standard treatment/services. 

In summary, the denial of  CPT code 0242U (Targeted genomic sequence analysis panel, solid organ neoplasm, cell-free circulating DNA analysis of 55-74 genes, interrogation for sequence variants gene copy number amplification and gene rearrangements) and coverage for the requested service should be overturned.  

This treatment is likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are not substantially increased over standard treatments.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Type I Diabetes.
Treatment: Ozempic.
The insurer denied: Ozempic.
The denial is upheld.

This patient is an adult female diagnosed with type one diabetes mellitus (T1DM). This request is for Ozempic. The provider states that Ozempic was approved through insurance. While the patient has been on Ozempic she has not developed any adverse events, her glycemic control has improved, and she was able to lose weight. The patient's glycated hemoglobin (A1C) was 7.7 percent. 

The proposed treatment is not medically necessary. 

Ozempic is a glucagon like peptide one receptor (GLP1R) agonist [1] that is Food and Drug Administration (FDA) approved in the treatment of type II diabetes [2-4]. There are no studies showing safety or efficacy of Ozempic in patients with type I diabetes. This patient has type I diabetes. The Food and Drug Administration label specifically prohibits use of Ozempic and type I diabetes. The request is not consistent with generally accepted standards of medical practice and is therefore not medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Neck pain
Treatment: Spine surgery
The insurer denied coverage for spine surgery
The denial is overturned
 
This is the case of a patient with a history of medial epicondylitis, gastroesophageal reflux disease (GERD), cervical spine fusion, brachial neuritis, degeneration of cervical intervertebral disc, neck pain, non-neoplastic nevus, and right breast lump. The patient presented for an office visit with complaints of neck pain, headaches, and a vibrating sensation down her right arm. A magnetic resonance imaging (MRI) showed anterior fusion at cervical (C) 5- C7 with degenerative disc changes, most pronounced at C4-C5 with moderate severe right C4-C5 foraminal stenosis. There was reported cord compression.  The patient has had physical therapy (PT) and chiropractic treatment without relief. The physician has recommended the patient undergo a C4-C5 anterior cervical decompression fusion and instrumentation. 

She had undergone the previous surgery a few years ago. She reported losing strength and dropping things. Her physical examination showed decreased sensation and strength on right side. She reported new onset of symptoms. A child pulled on her and she fell to the ground. Physical therapy began several months ago. Her physician opined adjacent segment degeneration with foramina stenosis.

The medical records were consistent in defining a pain generator. There is adjacent segment degeneration with neural compression. This patient has functional loss. There are correlative findings on physical examination for the diagnosis of nerve compression. She had a documented course of non-operative treatment. As this was not beneficial, the next step would be surgery, The recommended procedure would be removal of the disc with placement of a spacer. Bone spurs will likewise be removed. 

This spacer is called a cage. It is standard of care in the practice of Spine and Neurosurgery. There are no alternatives at this time. Simple bone graft is no longer placed. The cage will maintain height and provide a better healing environment.

Based on the above, the insurer's denial must be overturned. 

The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for spine surgery services is substantiated.
Appeal type: Medical necessity
Decision: Upheld


Diagnosis: Cholangiocarcinoma.
Treatment: Lenvima.
The insurer denied lenvima. 
The health plan's determination is upheld.

This is a female patient with metastatic cholangiocarcinoma. The patient has received gemcitabine+cisplatin, FOLFOX, irinotecan+durvalumab, and Abraxane. Lenvima has been recommended and is under review.

Lenvima is not medically necessary for this patient.
The use of lenvatinib in this clinical scenario is the subject of ongoing investigation in NCT03781934. Its routine use in this clinical scenario is not recommended by the National Comprehensive Cancer Network (NCCN) nor by the author of UpToDate. In this setting, there are other agents with more significant outcomes data and for which this patient has no documented contraindications. For these reasons, medical necessity is not established for Lenvima.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Infertility.
Treatment: assisted embryo hatching, microtechniques (any method), biopsy, oocyte polar body or embryo blastomere, microtechnique (for pre-implantation genetic diagnosis); greater than 5 embryos.
The insurer denied: Assisted embryo hatching, microtechniques (any method), biopsy, oocyte polar body or embryo blastomere, microtechnique (for pre-implantation genetic diagnosis); greater than 5 embryos.
The denial is: Overturned

The patient is a female undergoing in vitro fertilization (IVF) for infertility treatment. At issue is the medical necessity of assisted hatching and pre-implantation genetic testing (PGT) techniques.

The health plan's determination is overturned.

The requested service is medically necessary in the patient. Pre-implantation genetic testing (PGT) is an established adjunct that does have scientific, published evidence that it improves live birth rate per embryo and reduces multiple pregnancy rate and pregnancy loss in older women trying to conceive.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Cerebral infarction, paralytic syndrome following cerebral infarction, hemiplegia and hemiparesis.

Treatment: Ongoing Therapy Treatment.

The insurer denied coverage for ongoing therapy treatment.

The denial is upheld.

This is a child who has a history of abnormal electroencephalogram (EEG), cerebral infarction, paralytic syndrome following cerebral infarction, hemiplegia and hemiparesis, weakness, and attention and concentration deficit.  She has been receiving therapy, with documentation of benefit. The patient has derived meaningful benefit from therapy services, but still struggles with daily tasks that require the use of both hands.  Tasks she struggles with include pulling up her clothes after using the restroom.

The patient was evaluated by therapy and was authorized for 24 occupational therapy (OT) sessions. The patient was authorized 6 visits. The patient's mother wrote a letter requesting for additional therapy to be approved.

This patient has a supportive family and ongoing deficits can be addressed within the context of a home program supervised by trained, non-medical professionals such as family. Ongoing therapy is not medically necessary.

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for ongoing therapy treatment services is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Orthopedic/Musculoskeletal/Other/Acquired Clubfoot, left foot klinefelter syndrome / elective surgery
Treatment: Inpatient Admission Stay
The health plan denied the requested inpatient admission stay as not medically necessary. The health plan's determination is overturned.

The patient is a boy with Kleinfelter Syndrome, developmental delay, and bilateral severe clubfoot. The left clubfoot had been treated with casting as well as multiple soft tissue and bone surgeries since birth. The patient had some residual equinus that interfered with gait, and it was thought that it required repeat bone surgery of the foot (osteotomy and arthrodesis of the talonavicular and calcaneocuboid joints) to correct this deformity and improve the patient's gait.
At issue is whether inpatient level of care was medically necessary for this patient.

The health plan's determination of medical necessity is overturned, in whole.

Yes. This type of surgery is quite painful, and there is a risk of severe swelling and wound compromise if the limb is not strictly elevated afterward. This patient has developmental delay and it might not be easy to control his pain adequately at home, or to limit his activities in a way that would prevent compromise of the surgical wound. Inpatient medical care is justified and medically necessary after this surgery.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Orthopedic/Muscoloskeletal/Other/Acquired Clubfoot, left foot klinefelter syndrome / elective surgery
Treatment: Inpatient Admission Stay
The health plan denied the requested inpatient admission stay as not medically necessary. The health plan's determination is overturned.

The patient is a boy with Kleinfelter Syndrome, developmental delay, and bilateral severe clubfoot. The left clubfoot had been treated with casting as well as multiple soft tissue and bony surgeries since birth. The patient had some residual equinus that interfered with gait, and it was thought that it required repeat bony surgery of the foot (osteotomy and arthrodesis of the talonavicular and calcaneocuboid joints) to correct this deformity and improve the patient's gait.
At issue is whether inpatient level of care was medically necessary for this patient.

The health plan's determination of medical necessity is overturned, in whole.

Yes. This type of surgery is quite painful, and there is a risk of severe swelling and wound compromise if the limb is not strictly elevated afterward. This patient has developmental delay and it might not be easy to control his pain adequately at home, or to limit his activities in a way that would prevent compromise of the surgical wound. Inpatient medical care is justified and medically necessary after this surgery.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Low Back Pain
Treatment: Electrical Stimulation with a SPRINT PNS (Peripheral Nerve Stimulation) Device
The insurer denied electrical stimulation with a SPRINT PNS device.
The denial is upheld.

The patient is an adult female with low back pain and history of celiac disease. Sacroiliac joint injections worsened her pain. Right superior cluneal nerve cooled radiofrequency ablation (RFA) provided 90% (percent) relief for 3.5 months. The patient has also tried right L (lumbar) 3-4 transforaminal epidural steroid injection (TFESI) and right L4-S (sacral) 1 medial branch blocks last year without benefit. Physical therapy and acupuncture were ineffective. Current pain medication is cyclobenzaprine. Magnetic resonance image (MRI) of the lumbar spine from last year shows L3-5 disc desiccation with disc bulge and facet arthropathy. The request for peripheral nerve stimulation for unspecified mononeuropathy was denied as not medically necessary.

The proposed treatment is not medically necessary.

The requested service is unproven. There is insufficient or inconclusive evidence published in peer-reviewed medical literature to evaluate the therapeutic value. There are no well-designed and well-conducted studies. There is inconclusive evidence published in peer-reviewed medical literature that the service improves net health outcomes. The services' beneficial effects on health outcomes does not outweigh any harmful effects on health outcomes. The service under consideration is not as beneficial as any established alternatives. Small, published case studies do demonstrate the significance of peripheral stimulation as an innovative approach to treat chronic pain; however, more studies are needed to substantiate its effectiveness and safety. As such, the requested service is not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Preterm labor
Treatment: Inpatient admission
The insurer denied coverage for the inpatient admission.
The denial is upheld.

The patient is pregnant with a dichorionic diamniotic twin gestation who presented to the hospital with complaints of contractions. She was admitted to the Labor and Delivery (L&D) unit for monitoring. The patient was given 12 milligrams (mg) of betamethasone a day. The patient was given Penicillin. Maternal and fetal status were monitored. During admission no cervical changes were reported.

Preterm labor is an indication for admission and tocolysis. Preterm labor is defined as uterine contractions with cervical changes. During this admission, there was no documentation of any cervical changes. Repeat cervical examination did not show any changes. The patient was not in preterm labor. Ideally, this patient would have been observed in L&D, received intravenous (IV) fluid, and then reevaluated a few hours later. If upon reevaluation, no cervical changes occurred then she would be sent home. If cervical changes did occur, then she would be admitted for tocolysis and further management.

Please note that neither the patient nor the fetuses were in any jeopardy. There was no bleeding, and vital signs were stable. Fetal heart rate was reassuring. There was no evidence of ruptured membranes. The management that this patient received during her admission could have been done in a less acute setting: Once the provider ascertained that there was no evidence of preterm labor, (no change in cervical status after a few hours of observation) the patient could have been sent home after being hydrated. 

According to Milliman Care Guidelines (MCG) admission is indicated for one or more of the following:

-	Condition requiring premature delivery
-	Fetal distress or demise
-	Preterm prelabor rupture of membranes
-	Significant maternal disease
-	Vaginal bleeding
-	Complications of tocolytic treatment
-	Continued fetal monitoring that require inpatient care
-	Tocolytic therapy needed that requires inpatient care

Observation care is appropriate for patients with one or more of the following:

-	Condition requiring premature delivery suspected
-	Preterm premature rupture of membranes suspected
-	Suspected maternal infection
-	Ongoing uterine contractions (tocolytic therapy needed, monitoring of cervical changes needed)
-	Fetal distress suspected. 
-	Suspected placenta previa, vasa previa or placenta accreta

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for the inpatient admission is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Coronary artery disease, diabetes, and dementia

Treatment: Home health care (HCC)/ personal care - level 2 personal care services, per 15 minutes increase to 60 hours per week.

The insurer denied coverage for HCC/ personal care - level 2 personal care services, per 15 minutes increase to 60 hours per week.

The denial is overturned.

This is an elderly patient with medical problems including coronary artery disease, diabetes, and dementia. She lives with her son in a private home. She was hospitalized due to a right femur fracture then transferred to a nursing facility and subsequently was discharged to home. The patient is approved for personal care services (PCS) 41 hours/week and requesting 60 hours/week.  

The recent Uniform Assessment System (UAS) report was reviewed. The patient's cognitive status is described as minimally impaired. However, she "is dependent in all decision making" and "not able to provide health related information." In a letter, her treating physician indicates she has "advanced dementia." She was recently hospitalized for a femur fracture and had sacral and buttock pressure ulcers. The UAS report indicates she requires maximal assistance for bathing and lower body dressing. Extensive assistance is needed for personal hygiene, upper body dressing, bed mobility, ambulation, and toilet transfer/use. She is continent of bowel and bladder. The patient's cognition, impairments and continuing functional decline support the medical necessity of increasing PCS to 60 hours/week. Of particular concern are her deteriorating functional ability, fall risk and pressure ulcers. Based on the enclosed documents reviewed, this patient's health and safety can be more appropriately provided and maintained by the requested increase PCS, 60 hours per week.  

Taken into consideration were the clinical standards of the plan, information provided concerning the patient, the attending physician's recommendation and applicable generally accepted practice guidelines developed by the federal government, national or professional medical society, board and associations. All decisions are evidence-based.  

From a physical medicine and rehabilitation perspective, the requested HHC PCS - level 2 PCS, per 15 minutes increase to 60 hours per week is medically necessary.   

The health plan did not act reasonably, with sound medical judgment and in the best interest of the patient.

The insurer's denial of coverage for the home care / personal care (HHC) - level 2 personal care services, per 15 minutes increase to 60 hours per week is overturned. Medical necessity is substantiated.