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

Diagnosis: Varicose Veins
Treatment: Injection of Non-Compounded Foam Sclerosant 
(Varithena) 
The insurer denied Injection of Non-Compounded Foam Sclerosant (Varithena). 
The denial is upheld.

The patient is an adult female with a history of venous disease and venous insufficiency. She has undergone previous venous ablations with no active complications. 

The health plan should not cover the requested health service.

According to the office note, the patient is an adult female seen for right lower extremity chemical foam ablation for branches below the knee. There are no contemporaneous notes regarding any major symptoms directly associated with varicosities and venous insufficiency. The patient already had venous ablations that should have improved the patient's symptoms. The patient did not have workup for other etiologies regarding etiology of her discomfort and pain. The patient has no active ulceration, bleeding, phlebitis. Therefore, the health plan should not cover the requested health service.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Varicose Veins
Treatment: Injection of Non-Compounded Foam Sclerosant 
(Varithena) 
The insurer denied Injection of Non-Compounded Foam Sclerosant (Varithena). 
The denial is upheld.

The patient is an adult female. She has been evaluated for the treatment of lower extremities venous disease. The diagnosis was varicose veins. The treatment under review is injection of non-compounded foam sclerosant (Varithena [polidocanol injectable foam]) (code 36465).

The health plan should not cover the requested health service.

Endovenous low-nitrogen foam sclerotherapy of incompetent GSV (great saphenous vein), lesser saphenous veins, and accessory saphenous veins as was performed is unproven and not medically appropriate for treating Venous Reflux due to insufficient evidence of efficacy. In addition, code 36465 is denied for lack of submission of adequate documentation. There were no clinic notes nor venous duplex testing predating the date of service submitted. Therefore, the health plan should not cover the requested health service.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Lumbar Spine Injury
Treatment: Skilled Nursing Facility

The insurer denied coverage for skilled nursing facility. The denial is overturned. 
 
This is a patient with chronic medical problems, including atrial fibrillation diabetes, and coronary artery disease. The patient fell at home, where they live with their wife. The patient sustained a fracture to their wrist and forearm and went to the hospital, where the fractured wrist and forearm were placed in a cast. It was also determined that the patient had sustained a lumbar spine injury. As a result, the patient was transferred to another hospital and underwent lumbar spine surgery (L [lumbar] 2-4 instrumentation and fusion). The patient was eventually transferred back to the skilled nursing facility (SNF) and was discharged home over two months later. Under review is the medical necessity for a SNF extended stay.

The submitted SNF records support that the patient continued to be an appropriate candidate for the SNF level of care during the time under review (1, 2, 3). The therapy notes document gradual functional progress after several weeks of treatment. According to the physical therapy note, the patient was at the supervision level or independent for bed mobility and transfers. The patient was ambulating approximately 100 feet with a rolling walker and able to ascend/descend six steps with contact guard assistance. The patient was also essentially at the supervision level or independent for activities of daily living tasks such as dressing, hygiene, and grooming, aside from bathing, which was at the minimal to moderate assistance level. 

Subsequent notes document continued functional improvement, which was sufficient to support continued length of stay at the SNF level of care. The patient was essentially independent with functional mobility and activities of daily living. The patient was able to ascend/descend two flights of stairs with only supervision/contact guard assistance. The patient made excellent functional improvement because of the medical, nursing, and rehabilitation therapy care that was clinically appropriate and medically necessary. The patient was appropriately discharged to home at this point. 

Based on the above, the insurer's denial must be reversed. The health care plan did not act reasonably, with sound medical judgment, or in the patient's best interest. 

The medical necessity for the skilled nursing facility (SNF) extended stay is substantiated.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Post-menopausal vasomotor symptoms
Treatment: Prempro 0.625-2.5 milligram (mg) oral release (OR) tabs
The insurer denied coverage for Prempro 0.625-2.5 mg OR tabs.
The denial is upheld.

The patient has a diagnosis of post-menopausal vasomotor symptoms (VMS) and osteoporosis. A formulary exception for Prempro is requested.

For post-menopausal women with moderate to severe VMS and no history of breast cancer or cardiovascular disease nor moderate to high risk of these diseases, low-dose estrogen plus progestin therapy (or estrogen alone if no uterus) is recommended and is standard of care. Prempro 0.625 milligrams (mg)/2.5 mg therapy consists of a single tablet containing 0.625 mg of the conjugated estrogens found in Premarin tablets and 2.5 mg of medroxyprogesterone acetate for oral administration. It is indicated for women who have a uterus for the treatment of moderate to severe VMS due to menopause and prevention of osteoporosis.

Bijuva is a combination of an estrogen and progesterone indicated for women with a uterus for the treatment of moderate to severe VMS due to menopause and prevention of osteoporosis.

A combination of estradiol and norethindrone is used to treat moderate to severe symptoms of menopause. This medicine is also used to prevent osteoporosis after menopause.

According to the submitted information, the patient is complaining of VMS and has a diagnosis of osteoporosis. She is requesting coverage for Prempro. All three products contain an estrogen and a progestin. They all have the same beneficial effects as well as safety concerns.

The formulary drugs are not expected to cause adverse effects. 

There is no documentation that the formulary drugs were tried or that the patient had an adverse reaction or contraindication.

The formulary drugs are not expected to be ineffective.

The non-formulary drug is not expected to be more effective than the formulary alternatives.

The carrier's denial of a request for a formulary exception for Prempro 0.625-2.5 mg oral release (OR) tabs to treat menopause symptoms is upheld.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Chronic back pain
Treatment: Placement of a spinal cord neurostimulator
The insurer denied placement of a spinal cord neurostimulator.
The determination is overturned.

The patient is a female with a medical history significant for chronic pain and lumbar radiculopathy and a surgical history of right lumbar (L) 5 hemilaminectomy and discectomy. In a final adverse determination denial notice the health plan stated that the request was being denied because "records do not show that you have be evaluated by a spine surgeon." Since this time the patient was seen by a neurosurgeon who noted "I have reviewed the imaging for the lumbar spine that demonstrates some degenerative disease but not significant compression of neural elements. I also reviewed the MRI of the cervical spine as patient complained of pain in her neck that radiates down her upper extremities. I did not find any significant compression on the cervical spine MRI either. Given this finding, and the fact that patient had numerous prior injections with no significant relief, I think it is reasonable to trial a spinal cord stimulator to see if that alleviates her symptoms." At issue is the medical necessity of placement of a spinal cord neurostimulator.

The requested placement of a spinal cord neurostimulator is medically necessary for this patient and meets all criteria for inclusion.
The patient has chronic refractory pain present for greater than 6 months and has documentation supporting at least 6 months of nonsurgical medical therapy, including pharmacologic, psychologic, and physical therapy. Additionally, there is clear documentation of psychiatric clearance. Magnetic resonance imaging (MRI) of the lumbar spine was reviewed by a neurosurgeon, and there was no pathology indicated that would prevent safe lead placement. All of the facilities, equipment, and professional and support personnel required for proper diagnosis, treatment, and follow-up of the patient are available. The patient is free of contraindications to implantation. The medical record contains clear, objective documentation of degenerative spinal disease. A spinal cord stimulator for this patient is within generally accepted standards of care. The patient has had back pain for many years. She underwent right L5 hemilaminectomy and discectomy without resolution of her pain. She has exhausted conservative treatment options with physical therapy and multiple spinal injections. Lastly, she has received psychiatric clearance.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: CVA (cerebrovascular accident)
Treatment: Continued Skilled Nursing Facility (SNF)
The insurer denied: Continued Skilled Nursing Facility (SNF)
The denial is overturned.

The patient is an adult female with a history of general debility and ambulatory difficulty due to right MCA (middle cerebral artery) CVA (cerebrovascular accident) with left hemiplegia status post thrombectomy and right MCA (middle cerebral artery) stent. She was initially transferred to an acute Inpatient Rehabilitation Facility (IRF) with great improvement during SLT (speech-language therapy), PT (physical therapy), and OT (occupational therapy) rehabilitation. She was transferred from acute IRF (inpatient rehabilitation facility) to a Subacute/Skilled Nursing Facility (SNF) last month. The patient's ongoing medical issues include diabetes mellitus, hypertension, hyperlipidemia, 
aortic valve mass, and morbid obesity. Prior to admission, the patient was living with her husband in a 1-story-home with 6 steps to enter, independent with ADLs (activities of daily living).
The patient was admitted to SNF (skilled nursing facility) last month. As of 5 days post admission, she was dependent for bed-to-chair, sit-to-stand, upper/lower body dressing/bathing, toileting, 
hygiene, grooming, requiring maximum assistance with rolling, supine-to-sit, and sit-to-supine. The patient is at an increased risk of falls and further injuries.

The Continued Skilled Nursing Facility (SNF) is medically necessary.

The continued stay in SNF (skilled nursing facility) from 5 days post admission is medically necessary because of the patient's severe left hemiplegia associated with deficits that require intensive SLT (speech-language therapy), PT (physical therapy), and OT (occupational therapy). The patient was dependent for bed-to-chair, sit-to-stand, upper/lower body dressing/bathing, toileting, hygiene, grooming, requiring maximum assistance with rolling, supine-to-sit, and sit-to-supine. She is at an increased risk of falls and further injuries. Therefore, continued stay in SNF (skilled nursing facility) is medically necessary from the 5 days post admission forward, for up to 3 weeks, with further review at that point for progress.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Hypothyroidism
Treatment: Levothyroxine Capsule
The insurer denied: Levothyroxine Capsule
The denial is upheld.

This is an adult female diagnosed with Hypothyroidism. This request is for levothyroxine capsule.  As per the visit note her TFTs (thyroid function tests) are at goal on Tirosint 88 mcg (micrograms). She has Hashimoto with TSH (thyroid-stimulating hormone) close to goal of 0.42. As per the visit note 3 months ago; she has normal TSH (thyroid-stimulating hormone) on Tirosint 100 mcg (micrograms). 

Two years ago, her TSH (thyroid-stimulating hormone) was 0.42.; TPO (thyroid peroxidase) antibody was 370.1; Thyroglobulin was 2.7; thyroxine free was 1.6; T3 (triiodothyronine) was 0.65. Three months ago, her TSH (thyroid-stimulating hormone) was 0.518 (0.450-4.5).

The health plan should not cover the proposed treatment.

The formulary drug would be effective for this patient as the requested medication has the same composition as the formulary alternative. There is no documentation of failure or intolerance or contraindication to the formulary alternative. The requested therapy and the formulary alternative have the same efficacy. The formulary alternative would not have adverse effects on this patient.  

Tirosint is a brand name of levothyroxine.  Levothyroxine capsules are a generic formulation for Tirosint. The patient is reported to have hypothyroidism. Tirosint is FDA (Food Drug Administration) approved for the treatment of hypothyroidism (1). As with other forms of levothyroxine if it is effective in the treatment of hypothyroidism (2-5). There are no studies showing superiority of Tirosint over levothyroxine tablets brand-name levothyroxine.  There are no studies showing the superiority of levothyroxine capsule over Levothyroxine (GF-Mylan brand only). The patient can try the formulary alternatives. The patient has not been shown to have difficult to control thyroid function tests on the formulary alternatives. The request is not consistent with generally accepted standards of medical practice and is therefore not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Small Intestinal Bacterial Overgrowth (SIBO)
Treatment: Xifaxan 550mg (milligram) Tabs (3 times a day for two weeks)
The insurer denied: Xifaxan (milligram) 550mg Tabs (3 times a day for two weeks)
The denial is upheld.

The patient is an adult female with Crohn's disease and methane predominant SIBO (small intestinal bacterial overgrowth), with a positive SIBO (small intestinal bacterial overgrowth) breath test. Her provider is requesting treatment with Xifaxan 550 milligrams TID (three times daily) for two weeks.

The requested Xifaxan is not medically necessary.

Medical literature supports the use of antibiotics for the treatment of SIBO (small intestinal bacterial overgrowth). The health plan prefers that the patient try one of the plan-preferred alternatives before allowing for Xifaxan. There are many antibiotics that can be used to treat SIBO (small intestinal bacterial overgrowth), including Xifaxan. However, the plan-preferred antibiotics are also reasonable alternatives to treat SIBO (small intestinal bacterial overgrowth). These alternatives include Augmentin, Cipro, doxycycline, Metronidazole, Neomycin and Bactrim. As there is no medical literature to support that Xifaxan is more effective than the plan preferred alternatives, and as the patient is not documented to have tried and failed one of the plan preferred alternatives, the requested Xifaxan is not medically necessary. While the patient's provider asserts in its appeal letter that Xifaxan is the gold standard for treating SIBO (small intestinal bacterial overgrowth), and that the health plan's preferred alternatives do not treat SIBO (small intestinal bacterial overgrowth), medical literature supports that in addition to Xifaxan, the preferred antibiotics are safe and effective treatment for SIBO (small intestinal bacterial overgrowth).
Appeal type: Experimental/Investigational
Decision: Upheld

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

This is a female patient with complaints of low back pain and bilateral leg pain. The patient reports that her bilateral leg radicular pain has been increasing progressively. She has had transforaminal epidural steroid injections in the past. Magnetic resonance imaging (MRI) of the lumbar spine shows lumbar (L)5/sacral (S)1 levels with degenerative disc disease without focal disc herniation or severe spinal stenosis. L4/5 level show moderate central spinal stenosis secondary degenerative disc disease, L3/4 levels showed degenerative disc disease, L1 to L3 shows no evidence of disc herniation or spinal stenosis. At issue is whether the Intracept procedure is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

According to guidelines and cited references, despite promising early reports, further trials with longer-term outcomes and less risk of bias are required. There should be at least 6 months of chronic low back pain following a defined injury, refractory to conservative care, as well as Modic type I or II changes between L3 and S1 on magnetic resonance imaging.
According to Becker, et.al : "Seventeen patients with chronic, greater than 6 months, low back pain unresponsive to at least 3 months of conservative care were enrolled. Sixteen patients were treated successfully following screening using magnetic resonance imaging finding of Modic type I or II changes and positive confirmatory discography to determine the affected levels. The treated population consisted of eight male and eight female patients; the mean age was 48 years (34-66 years)."
Current evidence on the use of intraosseous radiofrequency ablation of the basivertebral nerve (Intracept) as a treatment of low back pain is limited to a single small observational study and one randomized controlled trial.
As cited above, Becker. et.al trial indicated only a 17-patient observational study.
These studies have not demonstrated long-term improvements in patient health outcomes, including pain and disability measures. Current evidence on the use of intraosseous radiofrequency ablation of the basivertebral nerve (Intracept) as a treatment of low back pain is limited to a single small observational study and one randomized controlled trial. These studies have not demonstrated long-term improvements in patient health outcomes, including pain and disability measures. In addition, no United States (US) guidelines based on research recommend this treatment. As such, the proposed health service or treatment Intracept 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: Back Pain
Treatment: Intracept Procedure
The insurer denied the Intracept Procedure.
The determination is upheld.

This is a female diagnosed with vertebrogenic low back pain. Records show that the patient was recommended to undergo the Intracept procedure, which was denied by the insurance carrier as this procedure is considered experimental/investigational. 
The provider notes the patient has a history of low back pain that began more than 2 years ago. She has had multiple treatments including home exercise, medial branch block injections, medication management, physical therapy, epidural steroid injections. The provider states that the patient had magnetic resonance imaging (MRI) performed demonstrating Modic changes at disc spaces lumbar (L) 5 and sacral (S) 1 and the provider believes that this is the source of her chronic back pain.
Magnetic resonance imaging (MRI) of lumbar spine revealed degenerative disc disease and spondylosis involving the lumbar spine producing moderate lumbar (L) 4 - L5 central spinal stenosis; mild bilateral L4 - L5 stenosis. There is 3-millimeter (mm) of anterolisthesis of L4 on L5 with no evidence of spondylosis.
The patient was seen for a follow-up visit regarding pain in the low back and bilateral leg, and presented to review her lumbar MRI. The patient reported that her bilateral leg radicular pain had been increasing progressively since the last visit with pain distribution 80 percent (%) in the back and 20% in the legs. It was that the noted patient previously had lumbar facet blocks with minimal benefit and the patient has had multiple lumbar epidural injections with varying degrees of pain relief. At issue is whether the Intracept procedure 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 Intraosseous Basivertebral Nerve Ablation Procedure (Intracept) 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 patient is noted to have a history of chronic back pain that has not responded to conventional conservative treatment. The provider feels that the patient's pain is coming from Modic changes and the patient was recommended to undergo the Intracept System (intra-osseous basivertebral nerve ablation). However, magnetic resonance imaging (MRI) shows multiple other findings that are likely potential pain generators. There is a lack of high quality studies evaluating the long-term risks and benefits of this procedure. Although some results have been promising, additional studies are needed to establish the safety and efficacy.
Appeal type: Experimental/Investigational
Decision: Upheld

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

This is a female patient with a significant medical history of ankylosing spondylitis who has lower back pain and bilateral lower extremity pain. The patient reports increasing radicular pain in the lower extremities with numbness sensation. She previously underwent bilateral lumbar (L) 4-5 and L5-sacral (S)1 facet block with minimal improvement. Her pain is across the lower back with radiation down to bilateral buttock and posterior thigh, right greater than left. The leg symptoms have been increasing recently. She underwent bilateral L5-S1 transforaminal injections with 2 weeks of pain relief. Her other treatments include physical therapy anti-inflammatory medications. The physical examination is significant for positive facet loading test and positive straight leg raise (SLR) on the right side. Magnetic resonance imaging (MRI) showed moderate central canal stenosis secondary to degenerative disc disease, ligamentous hypertrophy and facet arthropathy with mild bilateral L4-5 foraminal stenosis at L4-5, 3-millimeter (mm) anterolisthesis of L4 on L5. The patient was recommended for a lumbar epidural steroid injection at L5-S1 level with fluoroscopic guidance and intraosseous basivertebral nerve ablation at L4-5 and L5-S1 level.
At issue is whether the Intracept procedure is 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 the vertebral body by ablating basivertebral nerves. This patient has back pain and increasing radicular pain in the lower extremities with numbness sensation for which she was recommended for a lumbar epidural steroid injection. Magnetic resonance imaging (MRI) showed moderate central canal stenosis secondary to degenerative disc disease, ligamentous hypertrophy and facet arthropathy with mild bilateral L4-5 foraminal stenosis at L4-5 with no Modic changes documented in the MRI report. Truumees's study supported the efficacy of Intracept procedure for vertebrogenic pain. However, the patients with radiographic evidence of other pain etiologies including disc bulge and facet arthrosis were excluded. (1) Given this patient's medical history, MRI reading, and the current clinical evidence, it is unlikely that the proposed Intracept procedure will be more beneficial than any standard treatment.