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

Diagnosis: Gastrointestinal Stromal Tumor (GIST)

Treatment: Stereotactic body radiotherapy (SBRT)

The insurer denied coverage for stereotactic body radiotherapy (SBRT).

The denial is overturned.

The patient has the medical diagnosis of gastrointestinal stromal tumor (GIST). The treating provider is requesting plan approval for treatment with coverage for stereotactic body radiotherapy (SBRT).

The patient has the medical diagnosis of GIST. The patient has been seen and treated with malignant GIST. The patient's GIST is stage lV, five, 5. The fractions of SBRT are requested. The intent is to save the right kidney. The patient is currently on Ripretinib with oligo-progression in only two sites, liver and a peri-splenic nodule extern radiation, even to a palliative dose, will completely sacrifice the patient's right kidney. The treating provider has ordered and recommended coverage for SBRT. The ability to spare once kidney is a significant benefit that is likely to be beneficial in this situation.

Therefore, the request is approved and medically necessary for this patient.

"Conclusions: Further corroborative work is needed to assess kidney function after SBRT and to better characterize the expected duration of local control and palliative relief following SBRT." (Verma, et al, 2017).

"Conclusions: Select patients with limited metastases treated with SBRT are long-term survivors. Future research should address the therapeutic benefit of SBRT for these patients." (Milano, et al, 2012)

The scientific evidence in peer-reviewed literature supports a result of improvement in health outcome.

Retaining two functioning kidneys improves health outcome. SBRT is a widely emerging modality of radiotherapy touted for its ability to minimize irradiation to surrounding tissues and to provide a vastly shortened treatment course that is highly biologically potent. The dose that will spare the kidney can easily be calculated and administered.

SBRT does not need final approval from the appropriate regulatory bodies for this diagnosis.

This patient is a very good candidate for SBRT. One of the patient's kidneys would be able to be saved with it.

SBRT is the best available treatment for this patient at this time.

The adverse risks are not increased over standard treatment and/or services, the requested is safer.

The requested service is likely to be more beneficial than any of the standard treatments and/or procedures for this patient.

The carrier's denial of stereotactic body radiotherapy (SBRT) is overturned.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Gastrointestinal Stromal Tumor (GIST)

Treatment: Stereotactic body radiotherapy (SBRT)

The insurer denied coverage for stereotactic body radiotherapy (SBRT).

The denial is overturned.

The patient is a female diagnosed with a gastrointestinal stromal tumor (GIST). She is currently on ripretinib with oligoprogression in only two sites (liver and a perisplenic nodule). The patient has oligoprogressive disease. The providers are hoping for a prolonged improvement in survival, as demonstrated by the patient's length of time with disease.

The scientific evidence in peer-reviewed literature does support a result of improvement in health outcomes.

The patient has an extremely rare clinical diagnosis and specific clinical situation. She has a GIST tumor diagnosed years ago and oligoprogression at two locations. She cannot be safely treated with palliative radiation. The American Society for Radiation Oncology (ASTRO) Model Policy for stereotactic body radiotherapy (SBRT) strongly supports the use of SBRT for complete ablation of tumors as well as for patients that require extra precision to treat a tumor when other techniques cannot safely treat the patient.

SBRT is delivered by a machine with the appropriate regulatory approval.

The patient is an excellent candidate for stereotactic body radiotherapy (SBRT).

The tumor can be completely encompassed safely, and all known progressive disease has a high probability of eradication.

SBRT is the best available treatment for this patient at this time.

Fractionated palliative radiation will exceed the kidney dose constraints.

There would be more side effects, specifically with the kidney with standard radiation.

The patient has a long disease-free interval for many years. She has two locations of progression. Standard radiation would exceed the kidney constraint and have a high potential for kidney damage. SBRT can more safely treat the patient and also allow for doses to completely eradicate all known disease.

Finally, the requested stereotactic body radiotherapy (SBRT) is likely to be more beneficial than any of the standard treatments/procedures for this patient.

The carrier's denial of stereotactic body radiotherapy (SBRT) is overturned.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: High Cholesterol
Treatment: Livalo
The insurer denied Livalo.
The determination is upheld.

The patient has a history of hypertension, gastroesophageal reflux disease (GERD), osteoporosis, tobacco abuse, and hyperlipidemia who is requesting coverage for pitavastatin (Livalo). In a Request For Drug Evaluation, her provider noted an intolerance to rosuvastatin and atorvastatin. There is no evidence in the medical records provided documenting a failure or intolerance to pravastatin, simvastatin, fluvastatin, or lovastatin.
At issue is whether the formulary drugs will be or have been ineffective, would not be as effective as the non-formulary drug or would have adverse effects.

No, there is no reason to conclude that the formulary drugs will be or has been ineffective, or would not be as effective as the non-formulary drug Livalo. There is no evidence of intolerance to pravastatin, simvastatin, fluvastatin, or lovastatin.
Although the patient apparently had some side effects from atorvastatin and rosuvastatin, there is no evidence that she had side effects from the other formulary drugs. In addition, there is no evidence that the non-formulary drug, pitavastatin (Livalo), would be more effective than the statins on the formulary. Therefore, based on the standard of care, and the peer reviewed literature cited in the references, the patient does not meet criteria for non-formulary medication exception for pitavastatin.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Constipation. 
Treatment: Trulance (plecanatide). 

The insurer denied coverage for Trulance (plecanatide). 

The denial is upheld. 

This is a patient with a history of cirrhosis and gastroesophageal reflux disease (GERD). A progress note states that the patient has unspecified constipation and that Trulance was started. 

UpToDate has an article titled "Management of Chronic Constipation in Adults." The article reviews the advised treatments such as fiber, laxatives, osmotic agents, and stimulant laxatives. There is also a discussion about management of severe constipation. Pharmacologic therapy includes Linaclotide, Plecanatide, Lubiprostone, and Prucalopride. These agents have been approved by the Food and Drug Administration (FDA) for treatment of constipation. 

The submitted medical records do not document that the patient has failed the formulary alternatives for the treatment of constipation. There is no record that the patient has tried and failed either Lubiprostone or Linzess. The formulary drugs are not likely to cause the patient an adverse reaction. The record does not show that the formulary drugs were ineffective. It is not known if the requested drug would be more effective since the formulary drugs have not been tried yet. Since there are formulary alternatives for constipation, the denial is upheld. 

The insurer's denial of coverage for Formulary Exception for Trulance (plecanatide) is upheld.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Vomiting.
Treatment: Inpatient stay. 
The insurer denied the inpatient stay. 
The health plan's determination is overturned.

The patient is a former premature infant who presented to the emergency department with vomiting, diarrhea, and dehydration.  He was well until one day prior to presentation when he developed multiple episodes of vomiting. The vomiting was described as copious with more than 10 episodes that had become bilious. He then developed diarrhea, decreased activity, and had a decreased number of wet diapers.
In the emergency department, he was noted to be irritable with a sunken fontanelle, prolonged capillary refill, and sunken eyes with no tears when crying. He received 2 boluses of normal saline and laboratory values were obtained as well as an x-ray. He was found to have hypernatremia, hyperchloremia, and metabolic acidosis with a bicarbonate of 15. He was given a dose of ondansetron, but was still unable to tolerate oral fluids. He was therefore admitted to the hospital for further management.

The inpatient Hospital Admission was medically necessary for this patient.
Indications for continued parenteral treatment in an inpatient setting include an inability of the child to take oral replacement therapy and failure of ORT (oral rehydration therapy) to provide adequate rehydration. This infant had dehydration with an abnormal physical examination and abnormal laboratory markers, and was unable to tolerate oral replacement therapy even after emergency treatment. Therefore, an inpatient admission for further management and monitoring was indicated.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: low back pain
Treatment: Intracept Procedure
The insurer denied the Intracept procedure. The health plan's determination is upheld. 

The patient is a female with chronic lower back pain (LBP) for 12 months causing significant impact on her activities of daily living (ADL), including sleeping, standing and sitting. There are some questionable radicular symptoms versus pain radiation thought to be a separate complaint and due to other degenerative findings found on magnetic resonance imaging (MRI). These include some disc protrusion, degenerative disc disease (DDD), facet hypertrophy, spondylosis and spinal stenosis. It is not clear if she has radicular symptoms since it is written as an indication for her MRI but not detailed on the physical examination and not included in the planning for management. She reportedly received multiple interventions including epidural steroid injections, medial branch blocks, physical therapy, medications including opioids, muscle relaxants and non-steroidal anti-inflammatory drugs (NSAIDs) although her response moderate and not adequate. 

The Intracept Procedure (Intraosseous Basivertebral Nerve Ablation) is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

This patient has significant limitations due to her chronic LBP and she is taking NSAIDs, Opioids and Benzodiazepines to manage the pain. The requesting physician notes that the pain is significant and limits ADLs. Additionally, the MRI report does not detail Modic changes and STIR (Short Tau Inversion Recovery) imaging is not included. It is hard therefore to determine with the information presented if this patient meets the criteria demonstrated in studies that predict she will benefit from the procedure. Due to the lack of substantiating evidence, the Intracept procedure is not indicated for this patient at this time.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: low back pain
Treatment: Intracept Procedure
The insurer denied the Intracept procedure. The health plan's determination is upheld. 

The patient is a female with complaints of low back pain. A magnetic resonance imaging (MRI) lumbar spine demonstrated multilevel disc and facet degenerative changes at multiple levels. Physical exam demonstrated facet loading test positive to the left into the right. The patient has failed 6 months of conservative treatment and has axial back pain. It is noted that the patient has failed spinal injections.

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

Diagnosis: low back pain.
Treatment: Intracept Procedure.
The insurer denied the Intracept procedure. 
The health plan's determination is upheld. 

This is a female who has a chief compliant of low back pain with intermittent radiation to the right hip. She had failed 3-month treatment with Analgesic medications, physical therapy (PT) and home exercise. Physical exam (PE) was unremarkable except positive facet loading tests. She was recommended for medial branch nerve blocks bilateral L (lumbar) 3-L4, L4-L5 and L5-S (sacral)1 for facet syndrome and spondylosis and ablation of basivertebral nerve of L3 through S1 (Intracept procedure). An magnetic resonance imaging (MRI) revealed multilevel facet arthropathy and degenerative disc disease. Mild central canal stenosis with moderate bilateral foraminal stenosis at L4-5.

The proposed (Intraosseous Basivertebral Nerve Ablation) is not likely to be more beneficial than any standard treatment or treatments for the insured's low back pain.
The Intracept procedure was designed to treat low back pain from vertebral body by ablating basivertebral nerves. The available medical records did not reveal adequate evidence that this patient's pain is from vertebral bodies. This patient has low back pain with intermittent radiation to the right hip. PE revealed positive facet loading tests. MRI revealed multilevel facet arthropathy and degenerative disc disease with mild central canal stenosis and moderate bilateral foraminal stenosis at L4-5. Current clinical studies supported the efficacy of Intracept procedure for vertebrogenic back pain. However, the patients with clinical evidence of other pain etiologies including severe spinal stenosis, disc bulge, nerve impingement, facet arthrosis and spondylosis were excluded from these studies. This patient will not benefit from the Intracept procedure based on her medical history, MRI findings and current clinical studies.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Genitourinary/Kidney Disorder - Female Infertility.
Treatment: Second in-vitro cycle. 
The insurer denied second in-vitro cycle.
The denial is upheld.

This is a female who has infertility. She has previously completed an in vitro fertilization (IVF) cycle that has a chromosomally normal embryo. At issue is the medical necessity of a second IVF stimulation cycle to create additional embryos. The subject under review is the medical necessity for a second in-vitro cycle.

The second IVF cycle is not necessary to treat her medical condition of infertility as a euploid embryo created approximately one month prior to the present denial should have a 30-55% (depending on the study) chance of yielding a child. This patient has a reasonable chance of pregnancy with the euploid embryo that has already been created.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low Back Pain
Treatment: Intraosseous nerve ablation 
The health plan denied the requested intraosseous nerve ablation as experimental/investigational.
The health plan's determination is overturned.

This is a female who has a medical history of peripheral neuropathy and chronic low back pain. She has constant low back pain localized in the lumbosacral junction level. Pain level is 9 to 10/10. Her pain is worse with bending forward and sitting. She had tried epidural steroid injections, lumbar medial branch nerve blocks, physical therapy (PT) and chiropractic manipulation without adequate improvement. She is unable to take nonsteroidal anti-inflammatory drugs (NSAIDs) due to a history of gastric ulcers, and Tylenol was not effective for her. A physical exam was unremarkable with a negative straight leg raise test. A magnetic resonance imaging (MRI) revealed Modic type 1 (degenerative end plate and marrow) changes at (lumbar) L4-5 and Modic type 2 at (lumbar/sacral) L5S1. Her pain is consistent with vertebrogenic pain. She was recommended an intraosseous nerve ablation.
At issue is whether the proposed treatment of an intraosseous nerve ablation is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

I overturn the health plan's determination of medical necessity, in whole.

Yes. The intraosseous nerve ablation procedure (intracept) was designed to treat low back pain from the vertebral body by ablating intraosseous nerves. There are multiple clinical trials demonstrating the efficacy of this intervention. This patient's persistent back symptomatology is consistent with vertebrogenic pain. She had tried extensive treatments including epidural injections, lumbar medial branch blocks, PT and chiropractic manipulation without adequate improvement. Her pain is level is at 9 to 10 /10 which is severe enough to have a negative impact of her activities of daily living (ADLs). Further interventions are medically necessary to improve her pain and functional level. Other potential treatment options are long-term use of medications (opioids) and lumbar decompression fusion surgery. However, none of these options has a high success rate, and all of them carries significant risks and complications. Given this clinical scenario, the intracept procedure is medically necessary as the appropriate next step intervention.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Low Back Pain
Treatment: Intraosseous nerve ablation 
The health plan denied the requested intraosseous nerve ablation as experimental/investigational.
The health plan's determination is upheld.

The patient is a female with a history of chronic low back pain. A magnetic resonance imaging (MRI) of the lumbar spine revealed degenerative changes. She has been treated with conservative care as well as lumbar epidural steroid injections. The treating physician has recommended intraosseous nerve ablation.
At issue is whether the proposed treatment of an intraosseous nerve ablation is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

The health plan's determination of medical necessity is upheld, in whole.

No. The proposed health service or treatment intraosseous nerve ablation would not likely be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
Intracept is a minimally invasive procedure that targets the basivertebral nerve for the relief of chronic vertebrogenic low back pain. However, the evidence is insufficient to determine that the technology results in an improvement in the net health outcome. While a recent study has shown promising results, the limitation of most of the studies performed include unavailable long-term comparative data, lack of a sham controls and short duration of follow-up.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Lumbar radiculitis
Treatment: Transforaminal Epidural Injection (Additional Pain Injections)
The insurer denied the Transforaminal Epidural Injection (Additional Pain Injections)
The denial is overturned.

The patient is a male with lumbar radiculitis secondary to a disc protrusion at L5-S1 (fifth lumbar spine vertebra  first sacral vertebra) compressing the right S1 (first sacral vertebra) nerve root. Symptoms are consistent of bilateral lower extremity parasthesia and weakness.

The patient completed physical therapy. He has also tried Tylenol and Advil with mild benefit. The patient's provider is requesting a bilateral L5-S1 (fifth lumbar spine vertebra  first sacral vertebra) TFESI (Transforaminal Epidural Steroid Injection). MRI (magnetic resonance imaging) shows a large disc protrusion at L5-S1 (fifth lumbar spine vertebra  first sacral vertebra) with S1 (first sacral vertebra) nerve root compression in the lateral recess unchanged from previous exam.

The patient's pain is rated a 6-9/10. The request was previously denied coverage by the health plan due to lack of documentation of completion of more than 6 weeks of physical therapy.

Yes, the Transforaminal Epidural Injection (Additional Pain Injections) is medically necessary.
Additional documentation from the provider indicates that the patient has met the physical therapy guidelines of failure of physical therapy for greater than 6 weeks.  Specifically the provider notes "patient completed physical therapy."  As such, the requested health service is medically necessary.

No, the health plan did not act reasonably, with sound medical judgment, and in the best interest of the patient.
While the initial clinical notes did not indicate this patient had met the physical therapy requirements, an additional letter the physician states the patient has done more than 6 weeks of physical therapy. As such the guidelines are now met.