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

Diagnosis: Low Back Pain
Treatment: Intracept Procedure
The insurer denied the Intracept Procedure.
The determination is upheld.

The patient was diagnosed with low back pain and with degenerative changes on lumbar magnetic resonance imaging (MRI). The Intracept procedure is proposed and is under review as to whether it is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
The proposed health service or treatment Intracept Procedure (Intraosseous Ablation of the Basivertebral Nerve) is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
A prospective case series and review of literature of basivertebral and sinuvertebral nerve ablation states (in part) "A review in literature is done on the pathoanatomy, pathophysiology and pain generation pathway in degenerative disc disease and chronic back pain. 30 patients with 38 levels of intervertebral disc presented with discogenic back pain" [1]. The case series and review of literature is limited to a small number of subjects.
A guideline issued by the International Society for the Advancement of Spine Surgery Guideline on intraosseous ablation of the basivertebral nerve for the relief of chronic low back pain concludes (in part) "Intraosseous ablation of the basivertebral nerve (BVN) is a relatively new minimally invasive treatment for the relief of chronic low back pain (CLBP) that is diagnosed using well-established clinical and MRI findings. The procedure is supported by level 1 evidence including 2 randomized controlled trials (RCTs) demonstrating a statistically significant decrease in pain and an improvement in function with outcomes sustained to at least 24 months in a limited number of studies" [2]. Multiple limitations of the guideline present, including:
(1) Industry funding is a potential source of study bias for the available data reviewed.
(2) Limited number of studies.
(3) Short-term follow up for the majority of studied patients.
(4) Unknown effect on the primary degenerative process.
A prospective, open-label, single-arm, multi-center study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain [3] describes improvements in pain and function following treatment, but the study is limited to 28 patients.
Reliable evidence shows that the consensus among qualified objective experts regarding the inherent nature of the Intracept Procedure is that further clinical studies, clinical outcomes research, or clinical trials are necessary to determine its safety, efficacy and anticipated outcomes as compared with the standard means of treatment of the condition in question.
Therefore, the Intracept Procedure (Intraosseous Ablation of the Basivertebral Nerve) is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low Back Pain
Treatment: Intracept Procedure
The insurer denied the Intracept Procedure.
The determination is upheld.

The patient has a history of low back pain. The pain is in the lumbar spine with radiation to the right hip and thigh down to the groin, calf and first and second toe with pins and needle sensation. This patient stated most of the pain is in his right leg. His lumbar spine pain is aggravated by all movements, worse with activities. The pain ranges from 6/10 to 10/10. He was treated with a Medrol dose pack multiple times. Physical examination documented tenderness to palpation (TTP) in the paraspinal musculature, and positive facet-loading tests. The history of present illness (HPI) clearly documented radicular pain. A magnetic resonance imaging (MRI) scan revealed a broad based right paracentral to foraminal hernation, which indents the ventral thecal sac and impinges upon the exiting right lumbar (L) 5 nerve root. There were facet arthropathy and Modic type 2 changes at L4-5 and L5-sacral (S)1. This patient previously underwent an L5-S1 epidural injection with 80% pain relief. He was recommended to undergo an Intracept procedure. The Intracept procedure was designed to ablate the intraosseous nerve within the vertebral body for the treatment of low back pain from the vertebral body.
At issue is whether the Intracept Procedure (Intraosseous Ablation of the Basivertebral Nerve) is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

The proposed health service or treatment is unlikely to be beneficial for the patient's medical condition.
The Intracept system was designed to treat low back pain from the vertebral body by ablating intraosseous nerves. A review of the available medical records did not show adequate evidence that this patient has pain from his vertebral bodies. This patient stated most of the pain is in his right leg. His pain appears to be radicular in nature in the right L5-S1 distribution with pins/needles sensation. The physical examination revealed positive facet loading tests. The MRI revealed a broad based right paracentral to foraminal herniation indenting the ventral thecal sac and impinging upon the exiting right L5 nerve root, and facet arthropathy at L4-5 and L5-S1. The patient responded well to a prior epidural injection at L5-S1, which supports radicular pain as a significant pain generator. These clinical facts indicate lumbar radiculitis and facet joint arthritis are his primary pain generators. Current published clinical studies supported the efficacy of the Intracept procedure for vertebrogenic pain. Patients with radicular symptoms and spinal stenosis were excluded from these studies.
Given this patient's medical history, physical exam (PE), MRI findings, result of a prior epidural injection, and the current clinical evidence, he is not a candidate for the Intracept procedure.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Plantar Fasciitis.
Treatment: Custom shoe inserts.

The insurer denied the custom shoe inserts.  The determination is upheld.

The patient has a history of diabetes and complaining of heel pain and was diagnosed with plantar fasciitis. She was treated with orthotics and responded well. She presented with increased heel pain. She was recommended stretching and icing. She was recommended radial shock wave treatment and new orthotics which were denied initially. She then underwent a cortisone injection. This reduced her pain temporarily and then she was approved for custom molded orthotics and the new orthotics were dispensed. The new orthotics resolved her symptoms she returned with recurrent heel pain. At this visit, the provider recommended icing and stretching and again requested a new pair of custom molded orthotics for her recurrent heel pain which was denied. It appears based on the notes that the patient did not complain of heel pain on this visit. At issue is the medical necessity of the custom molded orthotics.

The patient initially had pain and diagnosed with plantar fasciitis.  She was initially treated with first line treatment options which failed and then was recommended custom molded orthotics, which were helpful in relieving the symptoms. The patient then developed a flare up of her plantar fasciitis but has not undergone any first line treatment options.  She should undergo first tier treatment options for her flare up prior to second tier treatment.

The patient was diagnosed with plantar fasciitis and was treated appropriately, which resolved her pain. She had a flare up years later and was recommended new custom molded orthotics as a first line treatment. Based on the guideline recommendations and literature, custom molded orthotics are not recommended for first tier treatment in plantar fasciitis and are reserved for second tier when other conservative measures have failed. This patient has been diagnosed with plantar fasciitis and has not failed all first tier conservative treatment options.

Thus, the custom shoe inserts are not considered medically necessary for this patient at this time.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Class III Malocclusion.
Treatment: Braces.
The insurer denied braces. 
The health plan's determination is overturned. 

The patient in question is a male with a Class III malocclusion, moderate spacing of the upper and lower arches and anterior crossbite of teeth #8-9. He has a supernumerary mandibular left first premolar. He is treatment planned for 24-30 months of orthodontics to correct his malocclusion.

The braces are medically necessary for this patient. The patient has significant spacing with teeth #8-9 in crossbite. These teeth have a high risk for restorative problems in the future due to their traumatic occlusion with the mandibular teeth. He is already damaging his lower central incisors. Studies have shown that even the untreated dentition shows increased anterior irregularity with time, which will make treating this occlusion at a later time more difficult. Orthodontic treatment now will likely prevent the need for future expensive periodontal and restorative procedures. For these reasons, braces are medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Congenital Adrenal Hyperplasia. 
Treatment: Triptodur.

The insurer denied coverage for Triptodur.  The denial is upheld. 

This patient is a male child diagnosed with Congenital Adrenal Hyperplasia (CAH). This request is for Triptodur. CAH is a complicated condition that leads to early puberty and advanced bone age. The patient entered puberty at an early age. He was started on pubertal suppression therapy with Lupron initially and his puberty has been suppressed and bone age advancement has slowed. His bone age is still significantly older. 

The patient was started on growth hormone (GH) therapy and eventually on Lupron depot and Arimidex. His latest medications are Hydrocortisone, dexamethasone, Saizen, Arimidex, Triptodur, and metformin. 

The definition of precocious puberty is children who have the onset of secondary sexual characteristics younger than age 8 in girls and younger than age 9 in boys [1-3]. 

The patient does not have documentation of testicular growth before age 9. The patient does not have documentation of a pubertal luteinizing hormone (LH) in the early stages of puberty. 

The patient does have other options in the form of aromatase inhibitors. The request for continuation is not consistent with generally accepted standards of medical practice and is therefore not medically necessary. The health plan acted reasonably, with sound medical judgment, and in the best interest of the patient. 

The insurer's denial of coverage for Triptodur is upheld. Medical necessity is not substantiated.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Leaking fluid
Treatment: 84112 - Amnisure (fetal fibronectin cervicovaginal secretions, semi-quantitative) 
The insurer denied the 84112 - Amnisure (fetal fibronectin cervicovaginal secretions, semi-quantitative). 
The denial is upheld.

The patient is a female. She presented to her obstetrician at 40 weeks gestation complaining of vaginal leakage. She was referred to a hospital to be evaluated in Labor & Delivery. An Amnisure ROM (rupture of membrane) test (84112) was performed to rule out rupture of membranes.

No, the health plan should not cover the 84112 - Amnisure (fetal fibronectin cervicovaginal secretions, semi-quantitative). 

If rupture of membranes is not obvious after visual inspection, the diagnosis can be confirmed by testing the pH (potential of hydrogen) of the vaginal fluid, which is easily accomplished with Nitrazine paper. A second confirmatory test is the presence of arborization (ferning). Finally, an ultrasound can be performed. The American College of Obstetricians and Gynecologists (ACOG) recommendations for diagnosis of rupture of membranes include the following points: Most cases of Premature Rupture of Membranes (PROM) can be diagnosed on the basis of the patient's history and physical examination.

The diagnosis is typically confirmed by the visualization of amniotic fluid passing from the cervical canal and pooling in the vagina, a basic pH test of vaginal fluid, or arborization (ferning) of dried vaginal fluid, which is identified under microscopic evaluation.

In equivocal cases, additional tests may aid in the diagnosis. Ultrasonographic examination of amniotic fluid may be a useful adjunct, but is not diagnostic. Fetal fibronectin is a sensitive but nonspecific test for ruptured membranes. Several commercially available tests for amniotic protein are currently available on the market with a reported high sensitivity for PROM. However, false-positive test results rates of 19-30% have been reported in patients with clinically intact membranes and symptoms of labor.

The requested therapy is not likely to be more beneficial for the enrollee than any available standard therapy.

Almost 3 years ago, the United States Food and Drug Administration (FDA) alerted women and their doctors about serious adverse events related to the improper use of tests intended as an aid in detecting if a pregnant woman's water has broken.

The FDA issued a letter to healthcare providers to remind providers that the labeling for these tests specifies that they should not be used on their own to independently diagnose a ROM in pregnant women. These tests have only been cleared for marketing by the FDA to be used by healthcare providers in conjunction with other clinical assessments to make critical patient management decisions regarding whether a ROM has occurred.

Note that the AmniSure test used independently had a sensitivity of 95.7%, specificity of 92.3%, positive predictive value of 84.9%, and negative predictive value of 98.0%.

In summary, the requested test is not likely to be more beneficial for the enrollee than any available standard test.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Leaking fluid
Treatment: 84112 - Amnisure (fetal fibronectin cervicovaginal secretions, semi-quantitative) 
The insurer denied the 84112 - Amnisure (fetal fibronectin cervicovaginal secretions, semi-quantitative). 
The denial is overturned. 

The patient is a G1 (one pregnancy) female. At 40 and 1/7 weeks gestation, she was referred to the hospital for a complaint of leaking fluid. An Amnisure test was performed to make the diagnosis of ruptured membranes. The health plan contends that the test is investigational/experimental and cites internal Medical Coverage Policy 0099, Tests for the Evaluation of Preterm Labor and Premature Rupture of Membranes. It states that criteria for experimental/investigational means that the technology in question is not demonstrated through existing peer-reviewed, evidence based, scientific literature to be safe and effective for treating or diagnosing the condition or sickness for which its use is proposed, the test is not approved by the FDA (United State Food and Drug Administration), the test is the subject of review or approval by an IRB (institutional review board) for the proposed used, and the test is the subject of an ongoing phase 1, 2, or 3 clinical trial.

Yes, the health plan should cover the 84112 - Amnisure (fetal fibronectin cervicovaginal secretions, semi-quantitative). 

The proposed treatment, diagnosis of ruptured membranes by demonstration of PAMG-1 (placental alpha microglobulin-1) in vaginal fluid (Amnisure) does not meet the criteria in the health plan's document for being experimental/investigational. Amnisure has been demonstrated to be safe and effective for diagnosing ruptured membranes and in fact has been demonstrated to be superior to conventional testing, i.e., nitrazine for this purpose. It is the only clinically commonly used method of diagnosis of ruptured membranes that has been demonstrated to be equivalent to the gold standard, transabdominally injected dye with observation for vaginal leakage. It is approved by the FDA, is not the subject of current review by FDA, and is not currently in the FDA approval process. The FDA warning and discussion in the relevant practice bulletin of the American College of Obstetrics and Gynecology do not state that it should not be used in the diagnosis of ruptured membranes, but rather that it not be used in isolation of other clinical data and examinations.

Yes, the 84112 - Amnisure (fetal fibronectin cervicovaginal secretions, semi-quantitative) is likely to be more beneficial.

As demonstrated by the literature cited in the references, it is superior to standard methods of diagnosis and is also the only clinically useful method that has been demonstrated to be equivalent to the gold standard.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: musculoskeletal

Treatment: Level 2 of 12 hours per day, 7 days per week

The insurer is denied coverage for  Level 2 of 12 hours per day, 7 days per week

The denial is upheld. 

This female patient has a history of esophageal reflux disease, hypercholesterolemia, osteopenia, osteoarthritis, hypertension, chronic pericarditis, anemia, lumbar strain, abdominal hernia, pericardial effusion, edema of the leg, colonic hemorrhage, chronic deep vein thrombosis of the left calf and dementia. The patient fell on and abraded her left arm. A lumbar spine computed tomography scan revealed moderate to severe multi-level degenerative changes with the disc space narrowing and osteophyte formation.  There was a calcified lesion adjacent to the left kidney measuring 2 centimeters that was consistent with a renal artery aneurysm. There was also a hyperdense left kidney lesion.  A renal ultrasound was recommended for further evaluation of the hyperdense lesion. She reports significant difficulty completing activities of daily living. Per the telephonic New York State Department of Health's Uniform Assessment System (UAS-NY), the patient lives with her husband in a 2 bedroom private home with access by 3 steps.  She is totally dependent for ordinary housework. The patient needs maximum assistance with meal preparation, managing medications, shopping and transportation.  She needs extensive assistance with managing finances, bathing, personal hygiene tasks, dressing her upper and lower body, locomotion and toilet transfer. She is frequently bladder incontinent but completely bowel continent. She is independent and needs set up help only with eating. The patient uses an assistive device for locomotion indoors. An increase to PCA services, Level 2 of 12 hours per day, 7 days per week, for a total of 84 hours per week is being requested.

New York Codes Rules and Regulations, Title: Section 505.14 Personal care services; 
(a) Definitions and scope of services.
(1) Personal care services means assistance with nutritional and environmental support functions and personal care functions, as specified in clauses (5)(i)(a) and (5)(ii)(a) of this subdivision. Such services must be essential to the maintenance of the patient's health and safety in his or her own home, as determined by the social services district in accordance with this section; ordered by the attending physician; based on an assessment of the patient's needs and of the appropriateness and cost-effectiveness of services specified in subparagraph (b)(3)(iv) of this section; provided by a qualified person in accordance with a plan of care; and supervised by a registered professional nurse. ...

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

The carrier's denial of coverage for the Level 2 of 12 hours per day, 7 days per week is upheld.  The medical necessity is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: atrial fibrillation with rapid ventricular response

Treatment: inpatient admission

The insurer is denied coverage for inpatient admission

The denial is overturned. 

This male patient has a history of hyperlipidemia and gastroesophageal reflux disease (GERD) who presented to the Emergency Department (ED) for evaluation of palpitations and associated dizziness. His vital signs at triage were: blood pressure 144/75, heart rate 130, temperature 36.1 degrees Celsius, respiratory rate 20, and oxygen saturation 98% on room air.  Electrocardiogram (EKG) revealed atrial fibrillation with rapid ventricular response (RVR). The patient was admitted to Telemetry for new onset atrial fibrillation with RVR. Cardiology was consulted. The patient underwent transesophageal echocardiography (TEE) without complications; and had successful cardioversion at 200 joules once and converted to normal sinus rhythm. The patient's symptoms improved following electrical cardioversion. The patient was discharged with Cardiology and Primary Care Provider follow-up.

Patients presenting with symptomatic atrial fibrillation and rapid ventricular rates require acute therapy and further monitoring to ensure that medications controlling heart rate and rhythm do not produce significant bradycardia. An analysis of 68 million Medicare patients admitted to the hospital for atrial fibrillation over a fifteen year period demonstrated an average length of stay of 3 days.(1) This analysis also demonstrated decreased mortality and readmission rates following admission to the hospital. In another study designed to evaluate a rapid treatment care plan for patients presenting to the hospital for atrial fibrillation, average hospital stay lasted for 64 hours in the rapid treatment group and 105 hours in the routine care cohort.(2) In this study, nearly 60% of patients in the routine care group required hospital admission. This patient presented with lightheadedness while in AF and initially did not respond to medical therapy. He was admitted to the hospital and scheduled for TEE/DC cardioversion DCCV. The current standard of care when managing patients presenting with symptomatic rapidly conducted AF includes hospital admission. In conclusion, inpatient hospital admission was medically necessary for this patient.

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

The carrier's denial of coverage for the inpatient hospital admission is overturned.  The medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Abdominal pain, nausea, and vomiting. 

Treatment: Inpatient stay.

The insurer denied coverage for the inpatient stay.

The denial is upheld. 

This is a male patient who presented to the Emergency Department (ED) with a history of left upper quadrant abdominal pain that radiated to the mid-abdomen. There was associated nausea and vomiting. Vital signs were within normal limits and the patient was afebrile. The patient had a computed tomography (CT) scan that did not definitely identify the appendix. However, there was noted to be a questionable appendix measuring up to 6 millimeters (mm). White blood cell (WBC) count was 16.9. The patient underwent an uneventful laparoscopic appendectomy and was discharged the next day. There were no reported complications. 

Admission may be necessary for patients with severe systemic illness (eg, sepsis), poorly controlled comorbidities (e.g., Chronic obstructive pulmonary disease, chronic heart failure), or complications from the procedure (e.g., infection, bleeding) that require more than 24 hours of postoperative care. This patient did not require more than 24 hours of postoperative care, and they were discharged within this time frame. According to clinical documentation, the patient was treated under observation standards. Peer-reviewed literature also indicates that laparoscopic appendectomy can successfully be performed as an outpatient procedure in those with uncomplicated appendicitis. Therefore, the requested hospital stay should be billed as observation status. 

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

The insurer's denial of coverage for the inpatient stay is upheld. Medical necessity is not substantiated.