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

Diagnosis: Left Knee Medial and Lateral Meniscus Tear, Subchondral Impaction Medial Tibial Plateau
 
Treatment: Subchondroplasty, 27599 and 29880-LT,  

The insurer denied the Subchondroplasty, 27599 and 29880-LT.  The denial was upheld.

Reviewer #1: 
This is a female patient with a history of left knee pain for several months. It was reported that the patient underwent imaging studies, physical therapy and cortisone injections for treatment of her condition. Diagnostic imaging revealed that she had medial and lateral meniscal tears with minimal degenerative changes and subchondral impaction with cystic change as well as a fluid-filled cavity in the subchondral edema in the medial tibial plateau. She underwent arthroscopic left knee surgery for repair of left knee medial and lateral meniscus tear, subchondral impaction medial tibial plateau. The patient experienced no post-operative complication.

The scientific evidence and peer-reviewed literature does not support improved health outcomes. Subchondroplasty with knee arthroscopy for osteoarthritis, musculoskeletal disease, bone marrow edema, subchondral bone edema, and knee osteoarthritis remains under investigation.  

The patient is not a good candidate for a knee subchrondroplasty for a meniscus tear. A knee sub chondroplasty for a meniscus tear is not the best available treatment for this patient at this time. The requested services are not likely be more beneficial than any standard treatment/procedures for this patient. Current guidelines generally discourage arthroscopy for patients with clear radiographic evidence of osteoarthritis with degenerative meniscal tears.  Current guidelines make strong recommendations against the use of arthroscopy in nearly all patients with degenerative knee disease, based on systematic reviews.  Among patients with a degenerative medial meniscus tear, knee arthroscopy was no better than exercise therapy. Knee arthroscopy for degenerative meniscal tears and osteoarthritis offers only a small change of a small benefit.   

The carrier's denial of coverage for the services described by codes(s) 27599 and 29880-LT performed should be upheld.
Appeal type: Experimental/Investigational
Decision: Overturned

Cancer
Chemotherapy

Diagnosis: diffuse large B cell non-Hodgkin lymphoma of the testicle
Treatment: YESCARTA
The insurer denied YESCARTA

The health plan's determination is overturned. 

The case involves a male patient with a diagnosis of diffuse large B-cell lymphoma of the right testicle with secondary central nervous system involvement. The patient has been treated with unilateral orchiectomy and testicular radiation as well as systemic therapy utilizing alternating R-CHOP and high dose methotrexate. Consolidative autologous stem cell transplantation was recommended, but was on able to be completed given failed pheresis attempts. The patient's oncologist has recommended that the patient proceed forward with CAR-T cell therapy utilizing axicabtagene ciloleucel (Yescarta).

YESCARTA is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
This patient unfortunately has exhibited disease progression despite conventional therapy and has a paucity of options remaining. Given the patient's age, ideally autologous stem cell transplant would be a preference after disease control is achieved with his current treatment protocol. However, there were multiple unsuccessful attempts to harvest stem cells eliminating this option. Other options with the potential to offer long-term disease control/remission include chimeric antigen receptor T-cells therapy as being proposed, allogenic stem cell transplant. There are certainly other salvage options which may provide transient disease control which include ibrutinib, lenalidomide, with or without rituximab, polatuzumab vedotin with rituximab, and selinexor.
Based on the totality of safety and efficacy evidence and lack of alternative option to provide long-term disease control outside of allogenic stem cell transplant, Yescarta is likely to be more beneficial for this patient.
Appeal type: Experimental/Investigational
Decision: Overturned

Cancer
Chemotherapy

Diagnosis: diffuse large B cell non-Hodgkin lymphoma of the testicle
Treatment: YESCARTA
The insurer denied YESCARTA

The health plan's determination is overturned. 

The patient is a male with diagnosis of diffuse large B cell lymphoma of testicular origin with central nervous system (CNS) involvement. He received standard RCHOP and rituximab with Methotrexate. He received radiation to testicles. He now has relapsed disease in CNS with an magnetic resonance imaging (MRI) of brain showing recurrence. He is undergoing salvage chemotherapy MATRIX modified Thiotepa and high dose cytarabine. He has undergone stem cell collection without success. He is now being considered for YESCARTA. This is the subject of this review.

YESCARTA is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
YESCARTA, CAR-T therapy seems to be the only option at this juncture for this particular patient. Autologous stem cell transplant is not possible due to inadequacy of stem cell collection. YESCARTA is Food and Drug Administration (FDA) approved for relapsed refractory diffuse large B cell lymphoma after two standard therapies. In this particular case, the patient has received two standard therapy and CART should be the next treatment of choice for a potentially curative therapy. Although many patients were excluded in the original trials of CART with CNS involvement, the FDA indication only excludes primary CNS lymphoma. This particular patient has diffuse large B cell lymphoma with CNS involvement. This is not a case of primary CNS lymphoma. There are now many published studies showed response to CART therapy in patients with CNS disease. (please refer to the references). Therefore, the use of YESCARTA is indicated for this patient.
Appeal type: Experimental/Investigational
Decision: Overturned

Cancer
Chemotherapy

Diagnosis: diffuse large B cell non-Hodgkin lymphoma of the testicle
Treatment: YESCARTA
The insurer denied YESCARTA

The health plan's determination is upheld. 

This is a male with diffuse large B cell non-Hodgkin lymphoma of the testicle. The patient received local therapy including a partial orchiectomy and radiation. The patient has been treated with high dose methotrexate and R-CHOP. He relapsed and is receiving salvage therapy with MATRix. Autologous CD34+ stem cell collection has failed. CAR-T (Chimeric antigen receptor T cells) therapy with Yescarta has been requested and is under review.

YESCARTA is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
Yescarta is a CD19-directed CAR-T immunotherapy that is approved by the US (United States) Food and Drug Administration for treatment of adults with relapsed or refractory DLBCL (Diffuse large B-cell lymphoma) after two or more lines of systemic therapy. This was approved based in part on results of the ZUMA-1 trial that included 101 patients with refractory disease or relapse within one year after autologous hematopoietic cell transplantation (HCT) reported 82 percent objective response rate (54 percent CR) and 52 percent overall survival (OS) at 18 months. Longer-term follow-up (median 27 months) reported 11 month median duration of response, 6 month median progression-free survival, >2 year median OS, and no additional treatment-related deaths or toxicity.
This patient, however, has not failed two prior regimens (only R-CHOP). Data on use of Yescarta in earlier lines of therapy is sparse and it is not recommended by the National Comprehensive Cancer Network (NCCN), the peer-reviewed literature, nor by the authors of UpToDate. Lacking data, it is not clear that Yescarta would be more beneficial than standard treatments in this setting.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis:Immunologic disorders
Treatment: Prescription drugs

Diagnosis: Immunologic disorders/other/Psoriatic arthritis
Treatment: pharmacy/ Prescription drugs/Otezla
The plan denied the service as not medically necessary. The health plan's determination is overturned in whole.

This is a  patient with psoriatic arthritis. The patient has a past medical history (PMH) of asthma/chronic obstructive pulmonary disease (COPD), which is why methotrexate (MTX) has not been tried. Cyclosporine is not effective in psoriatic arthritis (PsA).
The requested health service/treatment of Otezla is medically necessary for this patient. The patient has a PMH of asthma/COPD. MTX is not appropriate due to the patient's PMH of asthma/COPD and cyclosporine is not effective in PsA. Per UpToDate, potential respiratory complications of MTX include 'interstitial pneumonitis (rheumatoid arthritis 1%), chronic obstructive pulmonary disease, cough, epistaxis, pharyngitis, pneumonia (including Pneumocystis jirovecii), pulmonary alveolitis, pulmonary disease, pulmonary fibrosis, respiratory failure, upper respiratory tract infection'. Thus, it would not be appropriate to try MTX in a patient with underlying lung disease.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: squamous cell carcinoma.
Treatment: Proton Beam Therapy.
The insurer denied proton beam therapy. The health plan's determination is upheld. 

This is a man with a T2N2M1 HPV+ squamous cell carcinoma of the base of tongue with regional neck metastases as well as distant disease in the axilla and mediastinum. He chose alternative treatment after diagnosis  with vitamin infusions in Mexico as well as supplements, hyperbaric oxygen therapy and other alternative treatments. He had follow up positron emission tomography (PET) scans that showed some disease stable and other progressing. He was then on low dose chemotherapy and then addition of immunotherapy with follow up PET scans showing same results. He is not considered a surgical candidate. He is now interested in conventional treatment with concurrent chemotherapy and radiation therapy to the primary site of disease and proton beam approach is requested.

The requested IGRT with proton beam radiation therapy is not medically necessary for this patient. The proposed proton beam radiation therapy for this patient is not considered a standard treatment option recognized in the oncologic medical community. There are lack of any significant data published in peer reviewed medical literature supporting the efficacy and safety of proton beam radiation for head and neck malignancies. There are multiple studies published that are single institution non-randomized trials stating the need for addition trials to determine the efficacy and safety of proton beam radiation therapy as compared to photon beam radiation intensity modulated radiation therapy (IMRT).
This is also not supported by National Comprehensive Cancer Network (NCCN) Guidelines. This treatment is also recommended for a patient that has known distant metastatic disease where the treatment to the primary site would be considered palliative. The recommended proton beam radiation therapy is not indicated in this case.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: FGFR1 metastatic colon cancer
Treatment: Balversa (erdafitinib) tablets
The insurer denied the Balversa (erdafitinib) tablets. 
The denial is upheld. 

The patient is a male with metastatic colon cancer.  A Guardant360 liquid biopsy test was performed on the patient's blood. This was positive for fibroblast growth factor receptor one (FGFR1) gene amplification.   On the basis of this amplification, plan is for treatment with erdafitinib.

No, the proposed treatment is not medically necessary.

Erdafitinib (BalservaTM), a tyrosine kinase inhibitor of FGFR1-4 (1). Erdafitinib is approved by the FDA for treatment of bladder cancer (2).

The only clinical study of erdafitinib to treat colon cancer is a pre-clinical study (4). Erdafitinib for the treatment of colon cancer is not supported by the National Comprehensive Cancer Network (NCCN) Guidelines (NCCN Guidelines Version 4.2020, Colon Cancer). 

The histology of the cancer (site of origin) still remains crucial in the response to targeted therapy.  The presence of a genetic alteration in a cancer of a given type does not imply a response to treatment with an agent that is targeting that alteration.  A good example of this is response of tumors of different types to treatment with vemurafenib. Melanoma containing a BRAF V600 mutation most often respond to treatment with the BRAF inhibitor, vemurafenib (3).

Colorectal cancer cells also frequently have BRAF V600 mutations. Colorectal cancer cells that have BRAF V600E are resistant to treatment with BRAF inhibitors as there is a compensatory upregulation of epidermal growth factor receptor (EGFR) signaling (4). Data suggest that this treatment does not work well in colorectal cancer as there is feedback activation of EGFR signaling that minimizes the efficacy (5, 6). This has led to the suggestion that in order to target BRAF V600E mutations in colorectal cancer, simultaneous treatment with BRAF inhibitors such as vemurafenib and agents targeting EGFR signaling is necessary in the treatment of colon cancer (7).

In the absence of any published data to support the use of erdafitinib to treat FGFR1 amplified colon cancer, this treatment is best restricted to performance on a clinical trial. It is of unknown benefit.
Appeal type: Medical necessity
Decision: Upheld

Cancer
Cancer Screening

Diagnosis: Malignant Melanoma 
Treatment: Decision DX - Melanoma Test 
The insurer denied the Decision DX - Melanoma Test. The health plan's determination is upheld. 

The patient is a male with a history of Malignant Melanoma of the right mid-upper back that was biopsied. The Melanoma was read out as having a Breslow depth of 0.4 millimeter (mm), no ulceration, and with one mitotic figure per square millimeter field. No regression, perineural or lymphovascular invasion, or microsatellitosis were observed on histologic examination. The tumor was staged as T1A.

The Decision DX - Melanoma Test is not medically necessary for this patient. The Decision DX - Melanoma test is unproven and outside of standards of care after years and decades of ongoing outcomes testing and evaluations for Malignant Melanoma patients. At this time, the only proven prognostic features are histological in nature (Breslow Depth and Presence/Absence of Ulceration). The National Comprehensive Cancer Network (NCCN) 2018 guidelines do mention that the Decision DX - Melanoma and/or any other form of gene expression or genetic biomarker testing exists, and that this test is meant to determine whether a sentinel lymph node biopsy (SNLB) is indicated, but describes evidence for using this test to help determine proper melanoma treatment as being inconclusive and unsubstantiated at this time.
Appeal type: Medical necessity
Decision: Overturned in Part

Cardiac/Circulatory Problems
Surgical Services  (All)

Diagnosis: Varicose Veins
Treatment: Stab Phlebectomy and Sclerotherapy with Ligation 
The insurer denied the Stab Phlebectomy and Sclerotherapy with Ligation.
The health plan's determination is overturned in part. 

Left leg ambulatory phlebectomy with ligation is medically necessary for this patient based on the peer reviewed literature.
Left leg vein sclerotherapy is not medically necessary for this patient

The patient is a female who presents with bilateral lower extremity symptomatic varicose veins. Her main complaints include pain and swelling. She has attempted and failed conservative therapy with graded compression stockings without symptomatic relief for the past six years. She works as a nurse anesthetist and is required to be on her feet for long periods. Her pain interferes with her work activities. Her duplex ultrasound demonstrates reflux at the saphenofemoral junction only but not in the great saphenous vein.

-Left leg ambulatory phlebectomy with ligation is medically necessary for this patient based on the peer reviewed literature.
-Left leg vein sclerotherapy is not medically necessary for this patient.
Stab phlebectomy is a well-established and current treatment for symptomatic varicose vein tributary veins. The most recent consensus guidelines for the Society for Vascular Surgery and the American Venous Forum support stab phlebectomy for the treatment of symptomatic varicose veins when the patient's saphenous vein reflux has been treated either in staged or concomitant fashion. There are several current peer reviewed studies which support the use of concomitant stab phlebectomy in patients being treated with thermal ablation for symptomatic varicose veins. The ligation is medically necessary in conjunction with the stab phlebectomies to decrease the risk of bleeding from large feeding varicosities or perforators.
These procedures are supported by the most recent consensus guidelines from the Society for Vascular Surgery and the American Venous Forum. They are considered standard of care procedures in the Vascular Surgery Community and are Medically Necessary for this patient.
Based on the records provided, left vein sclerotherapy is not being requested. Therefore, it is not medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Constipation.
Treatment:  Linzess 290 mcg.

The insurer denied the Linzess 290 micrograms.  The determination is overturned. 

The patient has a medical history of chronic constipation, chronic abdominal pain, fibromyalgia, anxiety, migraine, endometriosis status post hysterectomy, hypertension, and nonalcoholic fatty liver disease.  She has failed MiraLAX and had only moderate benefit with Senna.  A colonoscopy was unremarkable.  Linzess 290 micrograms (mcg) daily for the treatment of constipation is requested.  The preferred formulary alternatives are lactulose, over-the-counter generic MiraLAX, over-the-counter Docusate, and over-the-counter sennosides.  At issue is the medical necessity of the Linzess.

The requested Linzess is medically necessary.  The patient has chronic idiopathic constipation.  The American Gastroenterological Association Medical Position Statement on Constipation states that when first-line laxatives fail, including a stimulant laxative (Senna in this case) and an osmotic laxative (MiraLAX in this case), a newer agent such as Amitiza or Linzess should be considered [1].  An attempt of a second osmotic laxative (such as lactulose) or use of a stool softener (such as docusate) is not specified.  In multicenter, randomized, blinded, placebo-controlled Phase III clinical trials, Linzess significantly increased weekly spontaneous bowel movements in patients with chronic constipation of multiple types [2-4].
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Abdominal pain
Treatment:  Inpatient hospital

The patient is a male admitted to the hospital.  The reason for admission was abdominal pain associated with markedly elevated aminotransferase liver enzymes.  The patient was recently discharged for rhabdomyolysis, which developed after intense exercise.  This was complicated by unknown ETOH use.  The patient has underlying depression and attention deficit disorder (ADD) and is treated with Prozac and Adderall.

The health plan's determination is upheld.  The inpatient stay was not medically necessary.  Rhabdomyolysis is a syndrome characterized by muscle necrosis and the release of intracellular muscle constituents into the circulation.  Creatine kinase (CK) levels are typically markedly elevated, and muscle pain and myoglobinuria may be present.  The severity of illness ranges from asymptomatic elevations in serum muscle enzymes (such as this patient) to life-threatening disease associated with extreme enzyme elevations, electrolyte imbalances, and acute kidney injury.  The serum CK begins to rise within 2 to 12 hours following the onset of muscle injury and reaches its maximum within 24 to 72 hours.  A decline is usually seen within three to five days of cessation of muscle injury and indicates recovery as seen in this patient.
Acute kidney injury (AKI) can occur in patients who have rhabdomyolysis.  AKI is caused by the nonprotein heme pigment that is released from myoglobin and is toxic to the kidney.  The prevention of AKI requires aggressive fluid resuscitation to maintain or enhance renal perfusion, thereby minimizing injury.  Among patients with rhabdomyolysis, fluid repletion should be continued until plasma CK levels decrease to less than 5000 unit/L and continue to fall.  Studies have shown that there is a low likelihood of AKI when peak CK levels are under 5000 to 10,000 unit/L.  This patient's level was still at 27,000 on admission; therefore, it was reasonable to provide additional IV fluids overnight.  This could have been provided at a lower level of care.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Nausea, vomiting and diarrhea
Issue under review:  Inpatient admission

Determination:
The Inpatient admission was not medically necessary.

This is an adult female with a history of systemic lupus erythematosus (SLE) who presented to the ER for further evaluation/management of nausea, vomiting and diarrhea.  Intake vitals were afebrile, hemodynamically stable with no evidence of severely febrile temperature, hypotension or tachycardia.  Examination was non-focal with no significant abnormalities noted, including no evidence of abdominal distention, involuntary guarding or organomegaly.  Laboratory testing and diagnostic imaging was negative for critical abnormalities, including no evidence of end organ damage.  The medical records demonstrate that the patient was admitted to the inpatient medical service in stable condition.  She received supportive care with IV fluids, antiemetics and prn analgesics with significant improvement in symptoms.  She was subsequently discharged in stable condition.  There is no evidence of intensification of services throughout the course of this patient's hospital stay.  Hence, the patient's care could have been safely furnished in a less intensive setting without adversely affecting patient's safety or outcome.  For these reasons, the inpatient admission is not deemed medically necessary.