Persius/hicric huggingface dataset:
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohn's disease
Issue under review: Stelara every four weeks

Determination:
The Stelara every four weeks is medically necessary.

The patient is an adult female with Crohn's. She has failed treatment with Remicade, Humira and Entyvio. She had been started on Stelara 90 milligrams (mg) every eight weeks with initial response, and then recently lost response.  The MD is requesting to increase Stelara to 90mg every four weeks.

The patient has lost response to Stelara 90mg every eight weeks. Medical literature supports dose intensification of biologics in patients who lose response to FDA approved dosing. Stelara has been found to be safe and effective at doses as high as 90mg every four weeks. 

1) Results from a retrospective cohort study of patients with Crohn's disease (CD) reported that among 122 patients on ustekinumab, 21 (17%) patients on every eight week maintenance dosing required dose intensification (frequency increased to every four weeks [n=11], every six weeks [n=5], or a combination of intravenous (IV) booster and frequency increase to every six weeks or every four weeks [n=5]). A total of 11 patients (52%) had clinical response after dose escalation (two [18%] were primary nonresponders to induction while nine [82%] had poor initial clinical response). 

2) A multicenter, retrospective, open-label cohort study of adults with moderate to severe CD was conducted to evaluate the long-term maintenance efficacy of ustekinumab therapy. During the maintenance therapy, dose escalation was required in 16.3% (17/104) patients and a combination strategy of reinduction and dose escalation was required in 6.7% (7/104) of patients. The most common escalated maintenance dosing was 90mg subcutaneous (SC) every four or six weeks. Clinical response was regained in 52.9% (9/17) of patients who had dose escalation, and 57.1% (4/7) of patients who had combined reinduction and dose escalation. 

3) Results from a retrospective, multicenter, open-label study of patients with refractory CD receiving ustekinumab, demonstrated that, among 11 patients who required a dosing interval reduction (includes 90mg SC every eight weeks to every four weeks [n=8], 90mg SC every eight weeks to every six weeks [n=1]), clinical improvement was seen in 73% (8/11) of patients.  

4) Results from a retrospective, open-label, observational study of ustekinumab for the treatment of anti-tumor necrosis factor (anti-TNF) resistant CD patients, demonstrated that, among patients who achieved clinical response at the last follow-up, dose escalation was required in 35% (7/20) of patients who received ustekinumab 90mg SC every eight weeks.

Therefore, the requested Stelara 90mg every four weeks is clinically appropriate and accepted standard of medical care, and is medically necessary, and should be covered by the health plan, who did not act reasonably by denying it.
Appeal type: Medical necessity
Decision: Upheld

Jaw Pain
Physical Therapy

The patient is a female who was being treated for temporomandibular joint (TMJ), headaches and jaw pain. It is noted that coverage was requested for transcutaneous electrical nerve stimulation (TENS) 97014 x 3 and 97750 computerized mandibular scanner. It is noted that this treatment was denied by the insurance carrier, as it was noted that one electrical stimulation treatment was already approved and the notes provided did not show that the patient had multiple treatments, while the provider was billing for three sessions, and multiple treatments of electrical stimulation would not be medically necessary so the extra treatments were denied. There was also a request for physical testing and there were no detailed reports of the results of physical testing, while records did not show that there was a medical need for this testing. The determination was upheld as not medically necessary on appeal. This denial is again under appeal, which is the subject of this review.

The health plan's determination is upheld. 

the requested health service/treatment of physical therapy services was not medically necessary for this patient. The patient is noted to have a history of TMJ with headaches and jaw pain and was undergoing physical therapy treatment. Progress note indicates the patient to have received electrical stimulation, pre TENS, EMG, CMS, and post TENS CMS. The note was handwritten and provided limited information. Regarding electrical stimulation, this is an untimed code and billing this code multiple times for the same date of service would not be medically necessary. There was reimbursement for one 97014 CPT code and the remaining 2 sessions would not be considered medically necessary. Computerized mandibular scanner (CMS), there was no detailed report provided in the therapy note documenting the details of this testing. There is no clear medical need identified in the actual medical records/therapy note provided to support the need for this testing.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Pre-syncope; vertigo; weakness
Treatment: Inpatient admission
The Inpatient admission was not medically necessary.

The patient is a male with history of hypertension and vertigo. He was seen at the emergency department with complaints of nausea, vomiting, weakness, blurry vision and vertigo. He did not have chest pain. 

The patient's review of system was positive for fever and dizziness.  His vitals were as follows: Blood pressure 147/94, heart rate 87 beats per minutes, respirations 16, oxygen saturation 96% on room air and temperature 98.8F. Physical examination was grossly unremarkable. 

Hospital investigations were as follows: WBC (white blood count) 11.72, hemoglobin 16.7, hematocrit 48.8, platelets 270, glucose 125, potassium 3.7, sodium 138, BUN (blood urea nitrogen) 10, creatinine 1.11, phosphorous 2.1, and magnesium 1.8.  Chest x-ray was normal.  EKG (electrocardiogram) shows normal sinus rhythm, left axis deviation, and possible left atrial enlargement.  Transthoracic echocardiogram was unremarkable. 

The patient's Assessment was presyncope, viral syndrome and abnormal EKG; he was admitted to telemetry.  Management plan in the emergency department includes intravenous normal saline, and Antivert. 

Follow up Hospital investigation notes negative cardiac enzyme. There was also a mention of fever spike to 102.6F; however, blood culture was negative, after five days. The patient left AMA (against medical advice). 

On presentation to the hospital, the patient was hemodynamically stable. He was admitted for presyncope, viral syndrome and abnormal EKG; however, there was no evidence of acute decompensated heart failure, or significant persistent life-threatening arrhythmias that would require inpatient management.  He did not have chest pain, and troponin was negative.  There was no evidence of sepsis, and blood culture was negative after five days. There was no evidence of altered mental status, confusion, significant electrolyte imbalance, anemia requiring transfusion or respiratory compromise.

In view of the foregoing, the proposed treatment is not medically necessary, because the care rendered could have been performed at a lower level of care without adversely affecting the patient's health.
Appeal type: Medical necessity
Decision: Upheld

Chest pain
Inpatient stay

The patient with chest pain presented to the emergency department (ED) with substernal chest pain for the two previous months. The chest pain was associated with shortness of breath and was intermittent. The pain was sharp in quality, substernal and non-radiating with nausea. There were no exacerbating or relieving factors.
The patient was seen by a cardiologist two months prior to presentation to the hospital and a 24 Holter monitor was placed. It revealed atrial fibrillation and the patient was started on Toprol for rate control. Patient was not started on anticoagulation. The chest pain persisted. The patient underwent an echocardiogram 5 days prior to presentation. The patient was evaluated in the ED. Blood pressure (BP) was 123/64, heart rate (HR) was 55 beats per minute (BPM) and temperature was normal. The physical examination was normal, patient was not in distress. The troponin was negative. A  computed tomography (CT) angiogram revealed mild biapical pleural parenchymal scarring and paraseptal emphysema. No pulmonary embolism. The patient was admitted to the hospital to rule out acute coronary syndrome. Serial troponin was negative. CKMB was normal. The pro-BNP was 68. Hemoglobin (Hb) was 11.1, and white blood cell (WBC) was 3.25. The rest of the labs were unremarkable. The patient underwent echocardiogram and it revealed normal left ventricular (LV) function, right ventricle (RV) systolic pressure at 31 millimeter (mm) Hg, trace mitral and aortic regurgitation. There was trivial pericardial effusion. The patient's chest pain resolved. Patient was discharged with follow up arranged. The HP determination is upheld in whole. The patient presented with atypical chest pain. The coronary risk profile was low,  physical examination was stable, although there was a short period with BP elevation. The cardiac markers, electrocardiogram (ECG), echocardiogram and CT angiogram were all unremarkable. Patient was treated with oral medications. The patient's condition and management could have been provided at a lower level of care. Inpatient admission was not indicated.
Appeal type: Medical necessity
Decision: Upheld

This is a patient who presented for chiropractic treatment of mid-back pain. Visual Analog Scale (VAS)was 9/10. The patient was treated for mid-back pain with ultrasound, mechanical traction and spinal manipulation. VAS on was 5-6/10 for mid-back pain, when she also presented with low back pain, VAS 3/10.  Spasm and subluxation were noted on all visits. The patient had previously been treated by this provider for neck and back pain over 60 times. At issue is the medical necessity of chiropractic services.
The health plan's determination is upheld.  Medical necessity for these services was not established. The notes lacked any detailed examination/re-examination and lacked any details on a non-supervised home rehabilitation program instituted to effectuate care. The thoracic diagnoses were unchanged, as was the treatment plan, even when a clinical plateau had been reached. The patient went over six months with similar chief complaints, and a lack of objective evidence of ongoing clinical improvements. As such, Maximum Therapeutic Benefit (MTB) had been reached.
Appeal type: Medical necessity
Decision: Upheld

Missing tooth/teeth
Dental/Orthodontic Procedure

The patient presented to the office of his dental provider for the evaluation and treatment of teeth #4,6,11, and 13. The planned treatment is bone graft for site #4, 6, 11, and 13 (6104), and implant placement (6010) for #4, 6, 11, 13.

From the documentation submitted for review, the patient is missing teeth throughout the maxilla as well as multiple teeth throughout the mandible. From the documentation there is no ridge deficiency diagnosed, no documentation of ridge dimensions or shape to indicate a deficiency, and no documentation of palatal vault depth nor shape. The HP determination of medical necessity is upheld in whole. Based on Professional guidelines, Standard of care, and peer-reviewed literature no therapy can be supported in the absence of supporting documentation, classifications, and diagnosis. The Provider's records and the X-rays do not support the requested therapy and thus the treatment cannot be designated as medically necessary. There is no documentation provided to support the medical necessity of an implant supported prosthesis.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Suspected angina
Issue under review: Cardiac stress test with nuclear imaging

Determination:
The Cardiac stress test with nuclear imaging is medically necessary.

The patient is an adult male. He presented for evaluation of exertional dyspnea, suspected angina. The patient has a baseline ECG (electrocardiogram) with ST segment elevation, suggestive of early repolarization. Nuclear stress test was requested due to abnormal baseline ECG.

The patient is presenting with new onset exertional symptoms, suggestive of angina, and this ischemic evaluation is indicated. The patient is able to exercise, however he has an abnormal ECG at baseline with ST segment abnormality, and thus a non-imaging ECG stress test would be prone to false positive results and would be difficult to interpret. Therefore, the SPECT (single photon emission computed tomography) myocardial perfusion imaging, which was requested, would be the appropriate test in this clinical scenario and would be consistent with the current standard of care.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Chronic hepatitis C

Treatment: Sofosbuvir-Velpatasvir

The insurer denied coverage for Sofosbuvir-Velpatasvir. The denial reversed.

This patient is a male patient with a medical history of an opioid addiction and a chronic hepatitis C. The viral load is elevated.  The genotype was reported by the lab to be indeterminate.

The American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) has issued guidelines for the treatment of hepatitis C.  Epclusa is indicated for the treatment of chronic hepatitis C for all genotypes, 1-6.   Since it works for all genotypes, it is the appropriate treatment for patients whose genotype is indeterminate.  This patient should be treated for his hepatitis C.  Sofosbuvir-Velpatasvir is an approved treatment of the AASLD for all genotypes.  The healthcare plan did not act reasonably or in the best interest of the patient.  Sofosbuvir-Velpatasvir is medically necessary for this patient.
	
The carrier's denial of coverage for the Sofosbuvir-Velpatasvir drug for the patient's Hepatitis C condition is reversed.  The medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Brain hemorrhage
Treatment: Continued Skilled Nursing Care

The proposed treatment of continued skilled nursing care is not deemed medically necessary. 

This is a male with a history of intracerebral hemorrhage s/p craniotomy and surgical evacuation. Due to impairments from this condition, he requires total assistance with all activities of daily living (ADLs). Despite the best efforts of the skilled nursing facility (SNF) staff, the patient has been unable to demonstrate significant progress with physical therapy or occupational therapy. Furthermore, there is no evidence of complex wound care, intravenous medications or other medical conditions which would require skilled nursing. For these reasons, the patient is appropriate for an alternative, lower, level of care. Therefore, this request for continuation of therapy at a nursing home is not approved. Termination of skilled nursing facility services is appropriate at this time as it is no longer medically necessary.
Appeal type: Experimental/Investigational
Decision: Overturned

This is a patient with a complaint of varicose vein located on the bilateral lower extremities. These varicosities were symptomatic with pain, aching, swelling, fatigue and nocturnal cramping. The symptoms had been present for years and were affecting day-to-day life. The patient underwent conservative treatment with compression for three months. This was unsuccessful and the patient is now seeking interventional treatment for the varicosities. There was also noted a discoloration on the right lower extremity that was present for three months and was not improving. On examination, bilateral lower extremity venous clinical severity scores were noted to be 10.
Based on the clinical presentation and failure of conservative treatment duplex ultrasonography of the bilateral lower extremity venous systems was obtained. Reflux was noted in both greater saphenous veins as well as the small saphenous veins.
At the time of evaluation, recommendation for endovenous laser ablation therapy (EVLT) of the bilateral greater saphenous veins and bilateral small saphenous veins was noted. The plan at time of initial consultation was to perform EVLT, however, at the time of treatment the patient was treated with VenaSeal. At issue is whether the requested procedure endovenous ablation of an incompetent saphenous vein with VenaSeal is likely to be more beneficial than any standard treatment or treatments.
The health plan's determination is upheld. Endovenous ablation of an incompetent saphenous vein with VenaSeal is not likely to be more beneficial than any standard treatment that can be rendered. This is based predominantly on the available and existing data surrounding the use of VenaSeal for endovenous ablation. The drug has approximately 36 months of reported data. It is widely accepted that five-year data is required prior to new treatments becoming evaluated for standard of care equivalency. The studies available so far do illustrate VenaSeal to be non-inferior to other standard treatments but do not exhibit elements of superiority in terms of outcomes or clinical severity score with respect to endovenous ablation. Other non-thermal techniques similar to VenaSeal are available. These are all as effective as thermal ablation; however, more data and further studies with appropriate power and larger numbers of patients with longer follow-up would be required to definitively prove superiority.
Appeal type: Experimental/Investigational
Decision: Overturned

This is a patient who presented with bilateral lower extremity symptomatic varicose veins. Her main symptoms include: pain, aching, swelling and fatigue. Her symptoms interfere with her activities of daily living and are lifestyle limiting. She has worn graded compression stockings for greater than 3 months' duration without symptomatic relief. Her duplex ultrasound demonstrates reflux in her bilateral great and small saphenous veins. Her provider performed bilateral great and small saphenous vein VenaSeal ablations. At issue is whether the endovenous ablation therapy of incompetent vein, VenaSeal, is likely to be more beneficial than any standard treatment or treatments.
The health plan's determination is overturned. The endovenous ablation therapy of incompetent vein, VenaSeal, is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. The patient presents with symptomatic and lifestyle limiting varicose veins of her bilateral lower extremities. She has failed conservative therapy with graded compression stockings. Her right great saphenous vein is dilated to 9-10 millimeters (mm) with junctional reflux measuring greater than 1-1.5 seconds. The left great saphenous vein is dilated to 7-8 millimeters (mm) with reflux of 1.5-2 seconds. The provider performed VenaSeal ablation to treat her bilateral great and small saphenous vein reflux. The patient is a good candidate for this technique.
Although endovenous thermal ablation is the standard of care treatment for saphenous vein reflux, there are side effects associated with this method of treatment which are widely recognized in certain anatomic situations. One indication for non-thermal treatment of the saphenous vein is the location of a vein in a superficial location. Thermal ablation is associated with skin burns which can provide significant morbidity for the patient.
VenaSeal closure of the great saphenous vein has been validated in the peer reviewed literature by Level 1 randomized evidence. It is Food and Drug Administration (FDA) approved in the United States for treatment of saphenous vein reflux. It is a preferred alternative to thermal closure in a patient with an anatomically superficial saphenous vein.
Morrison and colleagues demonstrated excellent results using VenaSeal in their randomized controlled trial. 
McHugh and colleagues also reported an excellent summary of the benefits of VenaSeal thermal closure for treatment of the incompetent saphenous vein. The authors concluded that non-thermal options promise comparable treatment efficacy without the added morbidity associated with high thermal energies. The potential of treating venous reflux without the risk of nerve damage may change how surgeons approach venous disease.
Appeal type: Experimental/Investigational
Decision: Overturned

This is a patient who was seen for signs and symptoms of chronic venous insufficiency. She failed conservative measures and had an ultrasound confirming reflux in bilateral great saphenous veins. The patient underwent VenaSeal vein closure of the affected veins. At issue is whether endovenous ablation therapy of incompetent vein, VenaSeal, is likely to be more beneficial than standard treatment(s).
The health plan's determination is overturned.
Yes, the requested procedure endovenous ablation therapy of incompetent vein, VenaSeal, is likely to be more beneficial than standard treatment such as radiofrequency ablation. There have been multiple studies that have been published that have shown VenaSeal to be safe and effective treatment. VenaSeal has been shown to be non-inferior to vein ablation in the VeClose study. More recent studies have shown that VenaSeal may be more beneficial for vein ablation and therefore may be better than other vein closure methods. A study published in Phlebology in July 2019 shows a higher closure rate of the great saphenous vein treated with VenaSeal versus radiofrequency ablation (RFA), 94.4% versus 91.9%.
Appeal type: Medical necessity
Decision: Overturned

This is a patient who was seen for glaucoma follow up. The patient has a history of selective laser trabeculoplasty in the right eye. She was started on Vyzulta secondary to intraocular pressure of 17/21 bilaterally on timolol, brimonidine and latanoprost. On exam, the patient had an intraocular pressure of 14/16 bilaterally, a cup to disc ratio of 0.85 in the right eye and 0.65 in the left eye, pachymetry of 540 in the right eye and 553 in the left eye, retinal nerve fiber layer of 84 in the right eye and 89 in the left eye. At issue is the medical necessity of Vyzulta.
The health plan's determination is overturned.

The intraocular pressure has improved on Vyzulta after failing treatment with timolol, brimonidine, latanoprost and selective laser trabeculoplasty. The retinal nerve fiber layer has thinning bilaterally and an enlarged cup to disc ratio.
Management of open-angle glaucoma has focused on reducing the intraocular pressure. The American Academy of Ophthalmology recommends that in treating open-angle glaucoma, the target intraocular pressure should be a 25% reduction of the baseline or untreated intraocular pressure and that it should be subsequently managed on an individual basis. Monotherapy may not be enough to produce the much-needed drop in intraocular pressure for some patients, and so combining drugs is the next alternative. If a monotherapy drug is only partially efficacious, other drugs with differing mechanisms can be added. The patient in this case did not have enough pressure reduction with timolol, brimonidine and latanoprost and so the change to Vyzulta was indicated. 
Bimatoprost is the formulary alternative to Vyzulta. The Vyzulta should be not be discontinued to start the formulary alternative of Bimatoprost as the intraocular pressure is currently controlled on timolol, brimonidine and Vyzulta. The discontinuation of the Vyzulta could result in destabilization of the patient's moderate glaucoma and result in worsening of the glaucoma and loss of vision. The current management should be continued as the intraocular pressure has been improved on Vyzulta .