Persius/hicric huggingface dataset:
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Type 1 diabetes mellitus
Treatment: Formulary Exception for Humalog Junior KwikPen (insulin lispro)
The insurer denied coverage for Formulary Exception for Humalog Junior KwikPen (insulin lispro)
The denial is overturned

This is a child newly diagnosed with Type 1 diabetes mellitus. This request is for Humalog Junior KwikPen. As reported; the patient manages her diabetes with frequent blood glucose monitoring both by fingerstick and by continuous glucose monitor, medical nutrition therapy and multi-dose injection of insulin. The provider states that the current rapid acting insulins on the patient's formulary only have 1-unit increments for dosing and place the patient at increased risk for hypoglycemia. The Humalog Junior KwikPen is a rapid acting insulin pen that allows for half unit dosing. 

The patient is a child and needs half unit increments. Since the patient needs half unit increments, the formulary alternatives - Fiasp FlexTouch or NovoLog FlexPen would not allow the titration of insulin to half unit increments. 

There is no documentation of trial or failure of the formulary alternatives because there is no formulary alternative provided by the insurer that will administer one-half unit increments.
  
The requested drug will be more effective than Fiasp FlexTouch or NovoLog FlexPen. 

The formulary drugs are expected to cause adverse effects.
 
The formulary drugs were not tried, and the patient did not have an adverse reaction or contraindication.

The formulary drug is expected to be ineffective.

The non-formulary drug is expected to be more effective than the formulary alternatives.

The carrier's denial of Request for Formulary Exception for Humalog Junior KwikPen (insulin lispro) to treat Type 1 Diabetes is overturned.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Metastatic high grade pleomorphic sarcoma. 
Treatment: Lynparza 100 milligrams (mg) OR TABS. 
The insurer denied coverage for Lynparza 100 mg OR TABS. 
The denial is upheld. 

This patient has a metastatic high grade pleomorphic sarcoma with metastasis. She has failed multiple lines of therapy. This patient has a breast cancer gene (BRCA) mutation. There is interest in administering Lynparza (olaparib). 

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome. 

Lynparza 100 mg OR TABS does not have final approval from the appropriate regulatory bodies for this diagnosis. 

While this patient is quite ill, she is likely able to tolerate this medicine. Olaparib (Lynparza) is neither Food and Drug Administration (FDA) approved, nor compendia listed for the patient's diagnosis. 

There are no studies which show that this drug is active or inactive in BRCA positive metastatic high-grade pleomorphic sarcoma as in this patient. This agent is undergoing ongoing study in sarcomas. The National Comprehensive Cancer Network (NCCN) lists treatment alternatives which include Dacarbazine for this diagnosis. 

Since this agent has no scientific data for the patient's diagnosis, the activity and toxicity is unknown. There are compendia-listed treatment options which have a defined level of activity in this disease. Since there are no studies demonstrating activity, this agent is not in accordance with generally accepted standards of medical practice. 

These five referenced compendia are the only authoritative compendial references recognized as authoritative by the United States government through Centers for Medicare and Medicaid Services (CMS). Not a single one of these authoritative references recommended this treatment for this patient's circumstances. 

In summary, the denial of Lynparza 100 mg OR TABS should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risk are unknown over standard treatments.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Metastatic high grade pleomorphic sarcoma. 
Treatment: Lynparza 100 milligram (mg) OR TABS. 
The insurer denied coverage for Lynparza 100 mg OR TABS. 
The denial is upheld. 

The treating provider has diagnosed the patient with metastatic high-grade pleomorphic sarcoma. The patient is breast cancer gene (BRCA) positive (+). The treating provider indicated there is clinical evidence for safety and benefit of Lynparza in targeting BRCA mutation. Based on Next Generation Sequencing (NGS) panel testing, the treating provider has requested Lynparza. 

All available medical documentation was reviewed.  The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome. 

The oral poly-ADP ribose polymerase (PARP) inhibitor olaparib is approved for the treatment of patients with recurrent ovarian cancer and a BRCA mutation, and has been shown to provide clinically meaningful benefit among such patients. The treating provider has submitted a case report for olaparib in colon leiomyosarcoma, which is not sufficient evidence to support the medical necessity in this case. 

Per Sargos, P., Sunyach, M., Ducassou, A., (2022), "a phase IB study of olaparib with concomitant radiotherapy in locally advanced/unresectable soft-tissue sarcoma from the French Sarcoma Group. There is an ongoing  phase II study of trabectedin and olaparib in treating patients with advanced unresectable or metastatic sarcoma; it is not a randomized study." 

Undifferentiated pleomorphic sarcoma (UPS) is a rare type of cancer that begins mostly in the soft tissues of the body. The mainstays of treatment for malignant fibrous histiocytoma (MFH) are complete surgical excision, most often supplemented with adjuvant radiation therapy. I did not find any literature on treating this sarcoma type with olaparib. 

Lynparza 100 mg OR TABS does not have final approval from the appropriate regulatory bodies for this diagnosis. It can be given off-label, but is not approved by the appropriate regulatory bodies for this diagnosis. 

This patient is not a good candidate for Lynparza 100 mg OR TABS. 

There is not sufficient support for its effectiveness as a single agent, as the drug is in a clinical trial for sarcoma. 

Lynparza 100 mg OR TABS is not the best available treatment for this patient at this time. 

Lynparza 100 mg OR TABS remains experimental. 

Per In, G. K., Hu, J. S., & Tseng, W. W. (2017), "Anthracyclines (e.g. doxorubicin) remain the standard of care for first-line therapy in high-grade soft tissue sarcoma (STS), regardless of subtype, presentation, and patient characteristics (Adv Med Oncol. 2017). 

The adverse risk is increased over standard treatment as the requested medication's utility is not proven. 

In summary, the denial of  Lynparza 100 mg (milligram) OR TABS should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risk are substantially increased over standard treatments.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Skeletal Class I malocclusion, crowding, and anterior open bite
Treatment: Braces
The insurer denied Braces.
The determination is overturned.

The patient presented with a skeletal Class I malocclusion and crowding. He has an anterior open bite. He is treatment planned for 24 months of orthodontics with extraction of teeth 5, 12, 21, and 28 to address the crowding and open bite. At issue is the medical necessity of braces.

Patients with an anterior open bite are among the most difficult patients to treat. (1) One side effect of anterior open bite is reduced maximum bite force with less muscle activity while chewing than patients without an open bite. (2) Orthodontics combined with either orthognathic surgery or permanent teeth extraction are often the choice of treatment to treat patients with an anterior open bite. (3) Orthodontic treatment is medically necessary for this patient due to the side effects described, and the fact that this is not something that will self-correct without orthodontic intervention.
Appeal type: Experimental/Investigational
Decision: Upheld

Reviewer #3:

Diagnosis: Low back pain

Treatment: procedure codes 64555 and C1778

The insurer denied coverage for procedure codes 64555 and C1778

The denial is upheld

According to the documentation submitted, this is a patient with a history of low back pain. The patient has suffered from chronic intractable pain in the bilateral lower back for years. The patient has tried different treatment options without relief of the back pain. The patient's magnetic resonance imaging (MRI) is notable for a broad-based disc bulge at lumbar (L) 5 - sacral (S) 1. The physician recommended the percutaneous peripheral nerve stimulation (PNS) procedure to treat lower back pain.

Current scientific evidence in peer-reviewed literature does not support the use of percutaneous peripheral nerve stimulators (pPNS) for the treatment of chronic low back pain. While some studies have compared the effectiveness of PNS to placebo, the overall quality of the evidence is weak and limited due to small sample size, short follow-up, and retrospective reviews. Studies have been mostly company sponsored, have had methodologic flaws, and were at risk for confirmation bias. To date there are no published systematic reviews and no published guidelines or position statements specifically addressing the use of PNS for the treatment of chronic low back pain. There are no evidence-based clinical practice guidelines that recommend the use of implantable peripheral nerve stimulation for treatment of chronic low back pain. The evidence is insufficient to determine the effects of the technology on health outcomes. While there is some evidence for the use of PNS for the treatment of conditions such as post-amputation pain, headaches, facial pain, arm and limb pain due to peripheral nerve injury, and post-surgical neuropathic pain, there is no evidence in the literature for the treatment of chronic low back pain pain. Centers for Medicare and Medicaid Services (CMS) Local Coverage Determination (LCD) - Peripheral Nerve Stimulation (L34328) does not list chronic low back pain as an indication with evidence of efficacy for coverage. (5) Adverse risks for implanted pPNS devices are not well defined. Infection, nerve injury, and implanted lead fracture are all possible with invasive regional nerve procedures. There are other evidenced based non-invasive treatments available such as psychotherapy and graded motor imagery. Based on this information, there is no reason to believe that the implantation of a PNS device will be more beneficial than standard non-invasive and evidence-based treatments for this patient. 

In summary, the denial of  procedure codes 64555 and C1778 should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risk are potentially increased over standard treatments.
Appeal type: Experimental/Investigational
Decision: Upheld

Reviewer #1:

Diagnosis: Low back pain

Treatment: procedure codes 64555 and C1778

The insurer denied coverage for procedure codes 64555 and C1778

The denial is upheld 

This is a patient with a history of low back pain. The patient has suffered from chronic intractable pain in the bilateral lower back for more than four years. The patient has tried different treatment options without relief of the back pain. The patient's magnetic resonance imaging (MRI) is notable for a broad-based disc bulge at lumbar (L) 5 - sacral (S) 1. The physician recommended the percutaneous peripheral nerve stimulation (PNS) procedure to treat lower back pain.

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome. The peripheral nerve stimulator has been proposed to treat axial back pain. It is still under investigation. There are no guidelines nor recommendations provided by national organizations. It is not mainstay in the treatment of chronic back pain. It is not recognized by practicing orthopedic spine surgeons nor neurosurgeon. It is a new modality provided by Pain Management Physicians. There are no long term studies. It is still Investigational and experimental. The physician recommended the treatment of PNS and referenced randomized controlled trials (RCTs). 

The requested procedure has Food and Drug Administration (FDA) approval for marketing. The FDA provides no treatment guidelines. 

The patient is not a good candidate for the requested procedure. The records show a traumatic event occurred (injury in a military vehicle). No defined pain generator has ever been established. Consultations have led from discogenic source to facet etiology with injections which were not beneficial. At this point the PNS has been proposed which is unlikely to solve the problem. 

The requested procedure is not the best available treatment for this patient at this time.

The adverse risk are increased over standard treatment/services. It is invasive and problems with instrumentation can occur. There could be complications from placement of probe, breakage or infection. 

In summary, the denial of procedure codes 64555 and C1778 should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risk are substantially increased over standard treatments.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chest pain

Treatment: Inpatient admission

The insurer denied coverage for inpatient admission

The denial is upheld 

This is an adult patient that presented to the hospital complaining of abdominal bloating, chest burning and dyspnea. The patient's past medical history was significant for hypertension and gastroesophageal reflux disease (GERD). Upon arrival to the hospital the vital signs were stable: the blood pressure (BP) was 132/84 and the pulse was 65. No abnormal findings were noted on physical examination. A 12-lead electrocardiogram (ECG) revealed sinus rhythm with ischemic abnormalities and a normal QTc interval (interval on an ECG) of 431 milliseconds (msec). The patient was admitted to the hospital for observation and treatment. A computed tomography (CT) of the chest revealed a small pericardial effusion (no calcium score noted), an echocardiogram demonstrated a preserved left ventricular ejection fraction of 55-60%. Perfusion testing revealed no perfusion deficits, but transient ischemic dilatation of the left ventricle was reported. The patient was discharged on medical therapy. 

The health plan acted, with sound medical judgment and in the best interest of the patient. This patient presented with atypical chest pain and a past medical history of hypertension and GERD. The patient's pretest probability of coronary artery disease was low. Utilizing the HEART (risk assessment tool) score the patient was considered low risk. Utilizing the Thrombolysis in myocardial infarction (TIMI) risk score the patient also had a low risk of developing major adverse cardiac events in the subsequent 30 days. Risk assessment of patients presenting with chest pain and no significant ST (interval on a ECG) changes on the ECG was reviewed by Hedayati et al. Using the HEART score risk stratification schema, this patient would have a low risk of major adverse cardiac events (defined as myocardial infarction (MI), need for percutaneous coronary intervention (PCI), need for coronary artery bypass grafting (CABG), or death) in the six weeks following presentation. Using the TIMI risk score, this patient would have a low risk of major cardiac events within the two weeks following presentation. In conclusion, admission to the hospital to treat an acute cardiac event was not medically necessary. This patient could have been treated at a lower level of care.

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 inpatient admission is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Dental Disorder
Treatment: Braces and monthly visits
The insurer denied braces and monthly visits.
The determination is upheld.


The patient has a Class II malocclusion, moderate maxillary crowding and moderate mandibular crowding, moderate overjet and moderate overbite with a left posterior crossbite. At issue is the medical necessity of braces and monthly visits.

Using the Handicapping Labio-Lingual Deviation (HLD) index, the malocclusion would score a 15 with no auto qualifiers. Auto qualifiers include cleft palate deformity or cranio-facial anomaly, impacted permanent anteriors where extraction is not indicated, anterior crossbite causing clinical attachment loss and recession of the gingival margin, severe traumatic deviations, overjet 9 millimeters (mm) or greater, and underbite 3.5 mm or greater. The case requires a score of 26 or more for treatment to be considered medically necessary. The malocclusion in question does not meet the criteria to be classified as handicapping and treatment would not be considered medically necessary. Thus, according to the standard of care, the requested health service/treatment for braces and monthly visits is not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Pyelonephritis.

Treatment: Inpatient admission.

The insurer denied coverage for Inpatient admission.

The denial is upheld.

 
The patient was admitted for worsening abdominal pain. She was recently diagnosed with pyelonephritis and came to the emergency department (ED) because of worsening abdominal and back pain. She did not take the prescribed antibiotic on discharge. The patient has a neurogenic bladder and a foley catheter. She was afebrile with costovertebral angle (CVA) tenderness on the right. Labs showed a white blood cell count (WBC) of 4.8 and creatinine of 1.2. Urine was positive for nitrate and leukocyte esterase with no bacteria noted. The urine culture was negative. A Computerized tomography (CT) of the abdomen showed possible gastritis but otherwise normal including the kidneys. The chest X-ray did not show acute cardiopulmonary changes. She was treated with pain medications, antibiotics and intravenous (IV) fluid and discharged in stable condition.
 
The patient was hemodynamically stable, with normal oxygenation and negative cultures, did not have significant electrolytes disturbance or change in kidney function, did not have cardiac arrhythmias, no altered mental status or persistent nausea and vomiting with dehydration. There was no evidence of acute pyelonephritis to require admission. She was able to tolerate an oral diet and did not require total parenteral nutrition and her work up was negative.

There is no evidence-based literature supporting inpatient level of care as 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 inpatient admission is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Deep bite crowding
Treatment: Braces and adjustments for braces
The insurer denied braces and adjustments for braces.
The determination is overturned.

The patient has deep bite crowding in both the maxillary and mandibular arches. Tooth 18 is partially impacted. Tooth 28 is in crossbite and is displaced labially in the mandibular alveolus. The patient is treatment planned for 24-36 months of orthodontics with extraction of four premolars to correct these problems. At issue is the medical necessity of braces and adjustments for braces.

Yes, impacted teeth can lead to bone defects of the adjacent erupted teeth. (1) It is a generally accepted practice guideline to address the impacted tooth by attempting to surgically remove it or to gain space to allow the impacted tooth to erupt.

The patient has an impacted mandibular left second molar. These teeth should have erupted around age 12. (2) Side effects of impacted mandibular molars include a significant increase in periodontal defects distal to the erupted first molars (3) due to the inadequate development of bone in that region as a result of the impacted tooth. No treatment will put the mandibular left first molar (tooth 19) at risk.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Colostomy
Treatment: Inpatient Hospital Admission
The insurer denied: Inpatient Hospital Admission
The denial is: Overturned

The patient is a female with past medical history of chronic obstructive pulmonary disease (COPD), diabetes, hypothyroidism, hypertension, chronic kidney disease and opioid use who had previously undergone colostomy for ischemic colitis with sigmoid perforation presented for colostomy reversal. The patient underwent take down of left lower quadrant colostomy. The patient was hospitalized after the procedure. The patient was doing well on postoperative check on postoperative day #0. The patient was started on clear liquid diet. On postoperative day #1 the patient was doing well. The patient restarted on methadone. She was started on Bariatric 1 diet. She was encouraged to ambulate. On postoperative day #2 The patient was not passing gas. The patient was not having nausea or vomiting. On postoperative day #3 the patient was tolerating a diet and passing gas. The patient was discharged home on postoperative day #4.
The subject under review is the medical necessity for the inpatient hospital admission.

Inpatient hospital admission care is standard of care after colostomy closure of this kind. The patient is at high risk of complication due to the formation of a new colorectal or colocolonic anastomosis. This requires significant monitoring for associated complications. This procedure is on the Medicare "inpatient only" procedure list. The provided criteria for this case is for "Potentially ambulatory procedure or surgery". A 3-5-day hospital stay is typical for this surgery and thus it should not be considered a potentially ambulatory procedure or surgery.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low Back Pain.
Treatment: Basivertebral Nerve Ablation (64628 and 64629).
The insurer denied: Basivertebral Nerve Ablation (64628 and 64629).
The denial is upheld.

The patient is an adult male with low back, buttocks, and occasional left lower extremity pain. He had temporary relief with epidural steroid injections and medial branch blocks. He has 
tried physical therapy and chiropractor treatment. The patient's magnetic resonance image (MRI) of the lumbar spine shows disc bulge, spinal stenosis, and facet arthropathy throughout the lumbar spine. The request for L2-S1 Intracept was denied as 
experimental/investigational.

The health plan should not cover the proposed treatment.

Review of literature shows moderate-quality evidence that suggests this procedure is effective in reducing pain and disability in patients with chronic back pain who are selected based on Type I or Type II Modic changes as well as other inclusion and exclusion criteria used in published literature to date. However, non-industry funded high-quality, large prospective studies are needed to confirm these findings. 
At this time, there is not enough valid scientific evidence to show that the expected health benefits from the procedure, supply, equipment, or service are clinically significant and will have 
a greater chance of benefit, without a disproportionately greater risk of harm or complications, than other possible treatments; and that generally approved forms of treatment that are less 
invasive have been tried and did not work or are otherwise unsuitable. There is a lack of sufficient (enough) peer reviewed literature and data regarding the long-term outcomes of the 
procedure. No, the health plan should not cover the proposed treatment.