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

Diagnosis: Low Back Pain
Treatment: Intracept procedure

The insurer denied the Intracept procedure. 
The health plan's determination is upheld. 

This is a male who has a history of low back pain. Pain level is 7/10. He had tried medications including non-steroidal anti-inflammatory drugs (NSAIDs), tramadol, and muscle relaxants with no success. He underwent epidural injections, trigger point injections, and physical therapy (PT) in the past. According to the records, epidural injection provided some temporary improvement. Review of symptoms (ROS) documented back pain, joint pain, joint stiffness, joint swelling, muscle spasms and neck pain. Physical exam (PE) was unremarkable except bilateral lumbar paravertebral spasm. Lumbar magnetic resonance imaging (MRI) revealed mild endplate changes at the anterior aspect of L (lumbar)2-3 through L5-S (sacral) 1 levels, circumferential disc osteophyte with compression of bilateral intrathecal L4 nerve roots at L3-4 level, Circumferential disc osteophyte with compression of left intrathecal L5 nerve, and moderate left facet joint arthrosis at L4-5 level, Circumferential disc osteophyte with abutment of bilateral S1 nerves at L5-S1 level. This patient was recommended to have the Intracept procedure at L4-5 and L5-S1 levels.

The Intracept Procedure is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
The Intracept system was designed to treat low back pain from vertebral body by ablating intraosseous nerves. The available medical records did not reveal convincing evidence that this patient's pain is from vertebral bodies. MRI revealed mild endplate changes at anterior aspect of L2-3 through L5-S1 levels, L3-4, L4-5 and L5-S1 circumferential disc osteophytes with bilateral L4, left L5 nerve compression and abutment of bilateral S1 nerve root. He had an epidural steroid injection with temporary improvement, which suggested nerve impingement might contribute to his symptomatology. Current clinical studies supported the efficacy of Intracept procedure for vertebrogenic back pain. However, the patients with radiographic evidence of other pain etiologies including severe spinal stenosis, disc bulge, nerve impingement and facet arthrosis were excluded from these studies.
Given this patient's medical history of diffused mild anterior end plate changes from L2-3 through L5-S1 levels, multilevel disc bulge with nerve impingement, and the exclusion criteria in current clinical studies, he is not an appropriate candidate for Intracept procedure at L4-5 and L5-S1 levels.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low Back Pain
Treatment: Intracept procedure

The insurer denied the Intracept procedure. 
The health plan's determination is upheld. 

The patient is a male with history of low back pain without significant lower extremity pain. The patient failed treatment with nonsteroidal anti-inflammatory drug (NSAID), opioids, muscle relaxants, trigger point injections and epidural steroid injections. An magnetic resonance imaging (MRI) lumbosacral spine report indicates the presence of multilevel spondylosis and endplate changes at L (lumbar)1, L3, L4, L5 and S (sacral)1. There is a minimal examination of the lumbar spine documented with mention only of bilateral paravertebral muscle spasm at L4-S1.

The Intracept Procedure is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
Intracept is Food and Drug Administration (FDA) approved for:
"The relief of chronic low back pain of at least 6 months duration that has not responded to at least 6 months of conservative care and is also accompanied by either Type I or Type 2 Modic changes on MRI".
In this case, the radiologist's interpretation of the lumbosacral MRI indicates that there are "endplate changes". There is no specific mention of Modic Type I or II endplate changes. The requesting provider includes his own interpretation of the MRI adding that there are "Modic changes" with no specific mention of Modic type I or II changes. Absent evidence of Modic type I or II changes on MRI, the Intracept procedure is not likely to be more beneficial in this case.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low Back Pain
Treatment: Intracept procedure

The insurer denied the Intracept procedure. 
The health plan's determination is upheld. 

The patient is a male with low back pain. Pain is noted to be 7 out of 10. Prior medications have included non-steroidal anti-inflammatory drugs (NSAIDs), tramadol, muscle relaxants, and injections. Magnetic resonance imaging (MRI) lumbar spine noted Modic changes at L (lumbar)4-5, and L5-S (sacral)1. The patient is noted to have vertebral generally chronic low back pain. Physical exam demonstrated that the patient was alert and oriented, with bilateral lumbar paravertebral spasm L4-S1.

The Intracept Procedure is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
This procedure is not recommended despite promising early reports, and further trials with longer-term outcomes and less risk of bias are required. A Food and Drug Administration (FDA) investigational device exemption trial examined 225 chronic low back pain patients with type I or II Modic changes who were randomized to the requested procedure or sham treatment, resulting in decreased Oswestry disability index (ODI) of 20.5 and 15.2 points, respectively. The authors noted that these marginally clinically meaningful improvements suggested some potential as a minimally invasive treatment, however, there is lack of data to recommend this procedure as treatment modality. In general, there is lack of substantial support for this procedure, and it is currently not considered standard of care.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Fatty Liver, Morbid Obesity. 
Treatment: Liver biopsy during bariatric surgery. 

The insurer denied the liver biopsy during bariatric surgery. 
The determination is upheld. 

The patient underwent bariatric surgery (laparoscopic Roux en Y gastric bypass and concomitant liver biopsy). The records support that she had a body mass index (BMI) of 41.38 kilograms per square meter (kg/m2). The operative dictation states that the surgeon noted a fatty liver and obtained a wedge liver biopsy from the left lobe of the liver. The submitted records do not include any pre-surgical lab, imaging or clinical data to indicate liver pathology. The pathology report provides the diagnosis of mild steatosis. The provider submitted current procedural terminology (CPT) code 47100 (liver biopsy, wedge). At issue is the medical necessity of liver biopsy during bariatric surgery. 

The submitted documentation does not support the medical necessity of concomitant liver biopsy at the time of Roux en Y gastric bypass. There is no documentation of liver pathology as might be obtained by pre-operative imaging or lab data to warrant liver biopsy. 
Accepted indications for liver biopsy include: Documentation of signs or symptoms of liver disease (abnormal liver function tests of unknown etiology, knowledge of a specific diagnosis that will likely alter the treatment plan, known liver disease where prognostic information about fibrosis may guide subsequent treatment, the presence of a mass or lesions or focal or diffuse abnormalities seen on imaging studies of unknown etiology). In this case there is no such documentation to warrant wedge liver biopsy. Routine liver biopsy is not an accepted or standard aspect of bariatric surgery.[1] 
According to generally accepted criteria, routine liver biopsy is not medically necessary in conjunction with bariatric surgery.[1] Liver biopsy is indicated if there is a suspicious growth on the liver, if there is scarring of the liver or if there is a condition of the liver as indicated by pre-operative imaging or lab data that requires biopsy. 
In this case the patient has morbid obesity with a body mass index of 41.38 kg/m2. Lab data and pre-operative imaging are not included with the review material and there is no description of clinical symptomatology to indicate liver pathology.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Right groin round ligament thrombosis.
Treatment: Inpatient hospital admission.

The insurer denied coverage for an inpatient hospital admission.  The denial is upheld.

The patient at 2 weeks post-partum presented to the emergency room (ER) with a painful right groin mass. She had recently been on antibiotics for a suture infection. She was found to have a round ligament thrombosis. She was initially placed on heparin. Multiple consults were placed. She was transitioned to Lovenox and discharged home.

This patient was hemodynamically stable, not bleeding and had no pulmonary embolism (PE) present. She could reasonably be expected to be able to be managed on an outpatient basis. Given her postpartum status, observational status would have been reasonable with discharge in 24-48 hours for ongoing outpatient care. As this patient had a condition that could reasonably be expected to be stabilized within 24-48 hours, a lower level of care such as observational status would be appropriate. Therefore, the request for inpatient hospital admission is not considered medically necessary for this patient.

"Not all patients who have acute deep venous thrombosis (DVT) need to be admitted to the hospital for systemic anticoagulation. The decision to treat DVT in the outpatient setting should be made in the context of the patient's understanding of the risk-benefit ratio, preferences, and clinical condition. Factors determining who may be considered for outpatient therapy are not well defined. However, several randomized trials and meta-analyses that have compared outpatient therapy with low molecular weight (LMW) heparin to inpatient therapy with intravenous (IV) unfractionated heparin suggest that treatment at home with LMW heparin is safe and effective in select patients [9,34-48]. Anticoagulant therapy should not be delayed while the decision is being made to treat the patient at home." (Tapson, V.F., et al. 2021).

"Generally, a person is considered to be in inpatient status if officially admitted as an inpatient with the expectation that he or she will remain at least overnight. The severity of the patient's illness and the intensity of services to be provided should justify the need for an acute level of care. An inpatient admission solely because the patient has been kept in observation status over 23 hours would not be considered medically necessary." (American Health Information Management Association, 2018).

"Observation was meant to be a short period of time for providers to assess whether patients required admission for inpatient care or could be discharged. Typically, this was meant to last fewer than 24 hours and only rarely spanned more than 48 hours." (Society of Hospital Medicine, 2021).

The health care plan did act reasonably, with sound medical judgment, and in the best interest of the patient.      

The inpatient hospital admission is not considered medically necessary for this patient. 

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

Diagnosis: Cardiomyopathy
Treatment: LifeVest (K0606)
The insurer denied the LifeVest (K0606)
The denial is upheld

The patient is a male for which a wearable cardiac defibrillator is under review. Cardiac catheterization demonstrated left main, left anterior descending (LAD), and circumflex disease. There was a coronary artery bypass graft. The patient's left ventricular ejection fraction (LVEF) on 01/2021 was 30-35%. Medical therapy included Coreg and spironolactone.

No, the health plan should not cover the proposed treatment.

No, the requested health service or treatment is not more beneficial than any standard treatment for the insured's condition or disease.
Indications for a temporary wearable defibrillator are similar to those for an automatic implantable cardioverter defibrillator (AICD).  A wearable defibrillator is necessary for those requiring a permanent defibrillator but have, at that time, a contraindication to automatic implantable cardioverter defibrillator (AICD) placement (i.e. infection, awaiting cardiac transplant).  Those with a cardiomyopathy status post revascularization and where medical therapy has been initiated, as in this case, have a potentially reversible cardiomyopathy.   An automatic implantable cardioverter defibrillator (AICD) at the time of the diagnosis and without an optimal trial of medical therapy (i.e. three months) and subsequent documentation of a persistent severe cardiomyopathy (left ventricular ejection fraction (LVEF) less than 35%), is not medically indicated.  Neither an automatic implantable cardioverter defibrillator (AICD) or a wearable defibrillator (Zoll Life Vest) at the time of the cardiomyopathy diagnosis, compared to revascularization optimal medical therapy for 90 days and an automatic implantable cardioverter defibrillator (AICD) if the left ventricular ejection fraction (LVEF) remains at or less than 35%,  has been established as standard of care towards improved cardiac outcomes.  Therefore, the Zoll Life Vest is considered not medically indicated in this case.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Cardiomyopathy
Treatment: LifeVest (K0606)
The insurer denied the LifeVest (K0606)
The denial is overturned

The patient is a male with history of dilated cardiomyopathy with left ventricular ejection fraction (LVEF) 30-35% and congestive heart failure (CHF) who was initiated on guideline directed medical therapy. Zoll LifeVest (external wearable cardioverter defibrillator) for protection from sudden cardiac death was approved and placed. Cardiac catheterization revealed multivessel coronary artery disease (CAD) and the patient underwent coronary artery bypass grafting (CABG) . LifeVest was continued. 

The health plan denied continued LifeVest use as it was deemed experimental and not medically necessary. This denial is being contested citing the patient's continued high risk for lethal cardiac event.

Yes, the health plan should cover the proposed treatment.
The American Heart Association (AHA) / American College of Cardiology (ACC) / Heart Rhythm Society (HRS) guideline recommends implantable cardioverter defibrillator (ICD) only if there is persistently reduced left ventricular ejection fraction (LVEF) less than or equal to 35% after 90 days despite tolerable medical therapy for post-revascularization (coronary artery bypass grafting [CABG]) ischemic cardiomyopathy patients. During this 90-day waiting period while optimizing medical therapy, there is increased risk of sudden cardiac death as described by Masri et. al in meta-analysis. Thus, wearable cardioverter defibrillator (WCD) is a reasonable (class IIb) treatment for primary prevention of sudden cardiac death in post-revascularization ischemic cardiomyopathy patients based on American Heart Association (AHA) / American College of Cardiology (ACC) / Heart Rhythm Society (HRS) guidelines. LifeVest has been in approval by the Food and Drug Administration (FDA) for two decades. LifeVest is not considered an investigational device.

Yes, the requested health service or treatment is more beneficial than any standard treatment for the insured's condition or disease.
It would not be clinically appropriate to place an implantable cardioverter defibrillator (ICD) device immediately in post-revascularized ischemic cardiomyopathy (ICM) patients to decrease the risk of sudden cardiac death. This practice is not recommended by the American Heart Association (AHA) / American College of Cardiology (ACC) / Heart Rhythm Society (HRS) guidelines since left ventricular ejection fraction (LVEF) could potentially increase by greater than 35% in a significant proportion treated with optimal medical therapy, thus avoiding the burden of permanent implantable cardioverter defibrillator (ICD) implantation associated lifelong infection risk.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Digestive System/Gastrointestinal-Gastroparesis.
Treatment: Inpatient hospital stay.
The health plan denied the inpatient stay as not medically necessary. 
The reviewer has upheld in whole the health plan's determination. 

This case involves a patient with gastroparesis who presented to the hospital for a per oral endoscopic myotomy (POEM) procedure. This was a scheduled procedure, which was completed uneventfully, and post procedure, the patient was admitted to medicine for monitoring. Before the procedure, the patient was tested for COVID-19, with a negative result. Supportive treatment with intravenous (IV) fluids, as needed Zofran for nausea, was started. The patient was given an empiric prophylactic antibiotic Levaquin, prescribed for 5 days. The medical team documents a plan to perform a small bowel series in the morning, with a plan to discharge if stable.
The patient remained stable overnight, with stable vital signs, slightly bradycardic, with heart rates of 43, but stable blood pressures. The small bowel follow-through series showed no evidence of obstruction. Diet was advanced to clear liquids, and the patient was continued on twice a day Proton-pump inhibitors (PPI) and prophylactic antibiotic. She did experience one bout of emesis. She was cleared for discharge by gastroenterology on a clear liquid diet and appropriate outpatient follow-up. 
The requested health service/treatment of inpatient hospital admission is not medically necessary for this patient. The patient underwent an endoscopic myotomy procedure in the hope of improving gastroparesis symptoms. The procedure was successfully performed without complications. The patient had one bout of emesis post-procedure with no evidence of gastrointestinal obstruction on small bowel follow-through series. Patients with known gastroparesis experience emesis frequently and did not require inpatient hospitalization for this symptomatology. Patients with gastroparesis often report pain sensation, and treatment is largely supportive. There is no evidence that the patient suffered complications from the procedure. The symptoms are in line with her previously established diagnosis. The documentation notes significant improvement in symptomatology within 24 hours and accomplishment of safe discharge. POEM procedure is typically a procedure performed at a lower level unless accompanied by complications, conversion to an open surgical procedure, postprocedural perforation, hemorrhage, hemodynamic instability. The documentation for this case provides no evidence of such complications. As a result, there is no indication for the inpatient hospital admission. A lower level of care treatment is appropriate.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Ulcerative Colitis. 
Treatment: Stelara 90mg (every 4 weeks). 

The insurer denied the Stelara 90mg (every 4 weeks). 
The denial is upheld. 

The patient is a female patient who has the diagnosis of inflammatory bowel disease. Specifically, the patient has a history of ulcerative colitis. The patient received Stelara as treatment for this condition. As the patient evidenced increasing symptoms attributable to their condition, the provider has requested the provision of Stelara at a decreased dosing interval of every 4 weeks. This is the subject of this review. 

No, the requested Stelara every 4 weeks is not medically necessary. 
The use of Stelara (ustekinumab) subcutaneously (SQ) 90mg (milligrams) every 4 weeks is not medically necessary for this patient. 

The patient has the diagnosis of inflammatory bowel disease (IBD). Specifically, the patient has the diagnosis of ulcerative colitis. The patient has received Stelara as treatment for this condition. The patient evidenced increasing symptoms attributable to their condition, between dosing. The treating provider has requested the provision of Stelara at a decreased dosing interval of every 4 weeks. The provider has requested Stelara at a dosing not approved by the FDA (United States Food and Drug Administration). A review of the literature indicates that there have been no significant studies to date demonstrating the safety and efficacy of Stelara dose escalation to every 4 weeks in ulcerative colitis.  Therefore, the request for Stelara (ustekinumab) subcutaneously (SQ) 90mg (milligrams) every 4 weeks is denied and not medically necessary for this patient. 

"The efficacy of antibody-based therapeutics depends on their pharmacokinetics. The pharmacokinetic and exposure response profiles of ustekinumab, a monoclonal antibody against interleukin 12/interleukin 23, are known in patients with Crohn's disease, yet there are few data from patients with ulcerative colitis." (Adedokun, et al.). 

"The efficacy of ustekinumab, an antagonist of the p40 subunit of interleukin-12 and interleukin-23, as induction and maintenance therapy in patients with ulcerative colitis is unknown." (Sands, et al.). 

"A subset of patients with Crohn's disease (CD) do not respond to ustekinumab at the standard dose of 90 mg every 8 weeks. Little is known about the efficacy of shortening the interval between doses." (Ollech, et al.). 

Yes, the health plan did act reasonably, with sounds medical judgment, and in the best interest of the patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: HIV (human immunodeficiency virus)
Treatment: Cabenuva 400-600 Suspension, Pre-service
The insurer denied the Cabenuva 400-600 Suspension, Pre-service
The denial is upheld. 

The patient is a male-to-female transgender HIV (human immunodeficiency virus).

A clinical note dated indicated that the patient missed Biktarvy for the past two weeks because she hates pills and forgets to take them.  The patient is requesting Cabenuva.  The patient is appealing denial of Cabenuva 400-600 Suspension.  The request was denied because the patient did not try and fail preferred formulary medications, Cimduo, Complera, Epizcom, and Deistrigo.

No, the treatment with Cabenuva is not medically necessary.
This patient has been taking Biktarvy for treatment of HIV (human immunodeficiency virus) infection. She is requesting change to Cabenuva suspension because she does not like taking pills and forgets to take Biktarvy.  The patient has not tried and failed the preferred formulary medications: Cimduo, Complera, Epizcom, or Deistrigo.  There is no documentation of contraindication to formulary alternatives.

Medically necessary services are those which are:
safe
effective
generally accepted national standard of medical practice
not provided primarily for convenience of the patient or the practitioner
the least intensive and/or most appropriate alternatives among diagnostic and treatment option.

The requested Cabenuva suspension is not medically necessary, because it is requested primarily for convenience of the patient, who has not failed Biktarvy or other formulary alternatives but prefers not to take pills.  In addition, medical literature does not support Cabenuva as being superior to the formulary alternatives.