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

Diagnosis: Atrial Fibrillation
Treatment: Inpatient Hospital Stay
The insurer denied the Inpatient Hospital Stay.
The determination is upheld.

The patient presented to the hospital for elective catheter ablation for atrial fibrillation. His medical history was remarkable for persistent atrial fibrillation and nonischemic cardiomyopathy with a left ventricular ejection fraction of 30 percent (%). Cavotricuspid annulus ablation, pulmonary vein isolation and posterior left atrial wall ablations were performed without complication. At the end of the procedure, the patient was in sinus rhythm. He was subsequently admitted to the hospital for overnight monitoring. He remained stable and was discharged. The medical necessity for an inpatient admission is at issue.

Based on the documentation provided an inpatient level of care was not medically necessary.
This patient underwent a transcatheter procedure for ablation of persistent atrial fibrillation. Given the complexity of the procedure, with transseptal punctures, catheter manipulation and ablation within the left atrium, full dose anticoagulation, and the proximity of the ablation lines to the esophagus, the complication rate is higher than that of catheter ablations for other supraventricular arrhythmias. Accordingly, despite at least two reports demonstrating the safety of same day discharge after pulmonary vein isolation (PVI), most electrophysiologists admit the patients for overnight observation post-procedure. However, this patient's procedure was uncomplicated. Post-procedure he remained hemodynamically stable and in sinus rhythm. Accordingly, while overnight observation was reasonable, the records provided do not indicate that an inpatient level of care was medically necessary.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Neurofibromatosis, type 2
Treatment: Everolimus
The insurer denied Everolimus.
The determination is overturned.

This is a patient with neurofibromatosis type 2 (NF-2), who was seen at a neuro-oncology clinic for multiple recurrent meningiomas and has had multiple surgical procedures for the same. The last magnetic resonance imaging (MRI) showed a growing area of enhancement at the temporal tip which per the institutional radiology report suggests a meningioma. The physician has requested Everolimus to treat the same, to control progression so a surgical procedure can be avoided while the lesion is still smaller in size. The Everolimus is under review.

Everolimus is a first generation mammalian target of rapamycin (mTOR) inhibitor. Even though it is not Food and Drug Administration (FDA) approved for this indication, it is otherwise an FDA approved agent and has shown therapeutic effect in multiple cancers where mTOR inhibition has been targeted. [1]

The current understanding of the mTOR pathway heavily involves it in the development of meningioma. Its activation is strongly dependent on phosphatidylinositol-3-kinase and protein kinase B (PI3K/Akt) signaling and the merlin protein. Both factors are commonly defective in meningioma cells, which indicates their likely function in tumor growth. [2]

Meningiomas, although usually low grade, can sometimes progress to high grade. In this case waiting versus subjecting the child to another surgery has more potential harmful effects than the benefit of using Everolimus to try to control progression. Studies have shown that NF-2 mutated meningiomas have a good response to everolimus and bevacizumab with increased progression-free survival time and progression-free survival time at 6 months. [3]
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Neurofibromatosis, type 2
Treatment: Everolimus
The insurer denied Everolimus.
The determination is overturned.

This is a female patient with a diagnosis of neurofibromatosis type 2 (NF2)-related schwannomatosis. She has multiple tumors including bilateral vestibular schwannomas which are associated with hearing loss, tinnitus, and balance issues. She has personally had intracranial meningiomas and vestibular schwannomas with surgical resection of two meningiomas and radiation therapy to these areas. She is no longer considered to be a candidate for surgical resection and cannot receive radiation again. The provider has recommended treatment with Everolimus to try and stabilize her tumors and prevent growth of new ones. The Everolimus is under review.

The proposed health service/treatment Everolimus 5 milligrams (mg) is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease as there are no standard treatments that are available.

This patient has meningiomas and schwannomas in the setting of NF2 that have limited treatment options. She is no longer considered to be a candidate for surgery and has already had radiation therapy. As per a recent review by Molaie, et al in regards to treatment of NF2, there "are currently no Food and Drug Administration (FDA)-approved biologic therapies for the treatment of NF2". The current available treatments are non-curative and surgical resection and radiotherapy, which this patient has already failed. As the tumors are typically slow growing, cytotoxic chemotherapies are not appropriate to treat a condition that is life-long, so the focus has moved to biologically targeted therapies. Mechanistic target of rapamycin (mTOR) signaling in NF2 can help target schwannomas, meningiomas, and mesotheliomas, which is most appropriate for this patient.

As per a recent Phase II study of mechanistic target of rapamycin complex 1 (mTORC1) inhibition using Everolimus, this treatment delayed the growth of NF2-schwannomas, the safety of the product was manageable, and when the medication was stopped, re-introduction of the product led to further stabilization of disease.

While this medication is not likely to lead to regression of disease, it is a reasonable treatment, based on the current scientific knowledge of NF2 related tumors, is relatively well tolerated, and is likely to at least cause stabilization of disease. As there are no other approved treatment options for this situation, the use of Everliomus is clinically appropriate at this time per the current standards of care and peer-reviewed literature.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Mixed irritable bowel syndrome
Treatment: Motegrity
The insurer denied Motegrity.
The determination is upheld.

This is a patient with irritable bowel syndrome, mixed-type. She reported constipation for the last few months; she had cramping with Miralax. She reported partial improvement with Motegrity. She has failed Bisacodyl, Golytely, Miralax, and Senna. Motegrity is requested for the treatment of irritable bowel syndrome, mixed-type. The request was not approved because Linzess has not been attempted. At issue is whether the formulary drug Linzess will be or has been ineffective, would not be as effective as the non-formulary drug Motegrity, or would have adverse effects.

Motegrity is not supported over the formulary alternative Linzess. Linzess is indicated for and is Food and Drug Administration (FDA) approved for the treatment of irritable bowel syndrome, constipation-predominant; Motegrity is not [1]. Linzess has a different mechanism of action than osmotic laxatives, and has proven effective for the treatment of irritable bowel syndrome, constipation-predominant and chronic idiopathic constipation [2]. Guidelines for the treatment of irritable bowel syndrome and chronic idiopathic constipation recommend the use of stimulant laxatives and osmotic laxatives, and then advanced agents such as Linzess; however, Motegrity is not recommended as safer or more effective than Linzess, and while American Gastroenterological Association guidelines strongly recommend Linzess for the treatment of irritable bowel syndrome, the guidelines do not recommend Motegrity [3-7]. For these reasons, the request for Motegrity is not supported over the use of Linzess by the provided documentation.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Mycobacterium avium complex (MAC)
Treatment: Arikayce 590MG/8.4ML (milligrams/milliliters) IN (inhalation) SUSP (suspension)
The insurer denied the Arikayce 590MG/8.4ML IN SUSP 
The denial is upheld.

The patient is a female with coronary artery disease (CAD) who was referred to infectious disease (ID) for Nontuberculous mycobacteria (NTM) infection. Computed tomography (CT) of the chest showed extensive bronchiectasis with pulmonary opacities, progressed from prior CT. Three sputum cultures in June grew out Mycobacterium (M.) abscessus, and a polymerase chain reaction (PCR) probe on one culture showed Mycobacterium avium complex (MAC), raising the possibility of mixed infection. The subject under review is the medical necessity for the requested Arikayce.

The health plan's determination is upheld.

Based on the provided records, the treatment with Arikayce is not medically necessary for this patient. First, there is no indication of any susceptibility testing performed on the isolates, or, if done, what were the results. Treatment decisions would typically be based on those results.

Second, current treatment guidelines for either isolate, M. Abscessus or MAC, do not include inhaled Amikacin (Arikayce) as initial therapy.
 
M. abscessus is resistant to many antibiotics and thus is very difficult to treat. Isolates are usually susceptible only in vitro to the parenteral agents amikacin, cefoxitin, and imipenem, and to oral macrolides (clarithromycin and azithromycin). (1, 2) Combination therapy of intravenous amikacin with cefoxitin or imipenem and an oral macrolide have been recommended by the American Thoracic Society (ATS)/Infectious Diseases Society of America (IDSA) and many other experts.(5) Based on current literature and this patient's infection and clinical status, the health plan's determination of medical necessity is upheld in whole.
Appeal type: Experimental/Investigational
Decision: Upheld

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

The patient is a male with chronic lower back pain (LBP) for greater than 1 year. It appears that the pain has been unrelieved and described as bilateral dull aching back pain counting for 70% of the pain with radiation to the legs accounting for 30% of the pain. The pain is rated as 4-10/10 and there is significant effects on the patient's activities of daily living (ADL). Conditions which exacerbate the pain were not described. The patient denied weakness or paresthesias. The patient used nonsteroidal anti-inflammatory drugs (NSAIDs), Percocet, as well as physical therapy. He had lumbar epidural steroid injections (ESI) and facet injections although the number and results are not well reported. It is unclear if he received lumbar Medial Branch Block, radiofrequency ablation (RFA) and if there was with minimal or at least temporary relief. The patient's review of symptoms was noncontributory. Positive physical examination findings included revealed thoracic and lumbar pain. It is unclear if there was pain with lumbar facet loading although there was bilateral paravertebral muscle tenderness. 

The 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.
It is not clear if the patient has exhausted all standard treatments to target the facet arthropathy as a source of pain. If the facet arthropathy has been excluded as a source of the patient's pain and its effects on performing ADLs then a trial addressing vertebrogenic pain specifically using the Intracept device may provide more benefit than other medical and standards therapies. However, this is not documented in the records provided.
It is not clear if the patient has significant physical limitations due to his chronic LBP. The requesting physician notes that the pain is chronic and can affect his ADLs significantly but there is no ODI (Oswestry Disability Index) score or specific explanation as to the degree of limitations. It is also not entirely clear if the pain originates from the facet arthropathy and if the patient responded to the facet injection, or if there was an attempt at facet radiofrequency ablation (RFA). The Intracept procedure is in its infancy but has received at least Food and Drug Administration (FDA) 510k clearance; meaning that is safe and effective compared to currently available therapies but this does not represent a full approval or speak to the overall effectiveness since other therapies have significant limitations.
Appeal type: Experimental/Investigational
Decision: Upheld

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

The patient is a male who has a history of chronic low back pain as well as neck pain. The patient has undergone cervical epidural injections, and has increasing low back pain with radiation down bilateral legs. Physical exam demonstrated restricted range of motion lumbar and cervical spine. Magnetic resonance imaging (MRI) of the lumbar spine with multilevel degenerative changes as well as facet arthropathy and disc bulging at L (lumbar) 3-4, L4-5, L5-S (sacral)1.

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 treatment modality. In general, there is lack of substantial support for this procedure, and it is currently not considered standard of care.
Given the above, 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.
Appeal type: Experimental/Investigational
Decision: Upheld

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

The patient is a male who has a one-year history of back pain. He underwent extensive treatments including acupuncture, facet injections, epidural injections, and physical therapy (PT). His medications include non-steroidal anti-inflammatory drugs (NSAIDs) and Percocet. However, none of these treatments provided adequate improvement. His pain level is 4/10 to 8/10 with a significant impact on activities of daily living (ADL). Physical exam (PE) revealed decreased range of motion (ROM) of lumbar spine and tenderness to palpation (TTP) in the lumbar paraspinal regions, and negative straight leg raise test. Magnetic resonance imaging (MRI) revealed multilevel disc bulges at L (lumbar) 3-4 L4-5 and L5-S (sacral)1 without nerve impingement, and degenerative end plate changes at L5-S1.

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 vertebral body by ablating intraosseous nerves. There are multiple clinical trials demonstrated the efficacy of this intervention. This patient has persistent back pain consistent with L5-S1 degenerative endplate changes. He had failed extensive treatments including epidural injections, facet blocks, PT and pain medications. His pain is severe with a significant impact of ADLs. Further interventions are medically necessary to improve his pain and functional level. Other potential treatment options are long-term use of medications (NSAIDs, 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 indicated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Chronic respiratory failure.
Treatment: Durable Medical Equipment (Volara Device 
E1399).
The insurer denied: Durable Medical Equipment (Volara Device 
E1399).
The denial is overturned

The patient is an adult male with developmental delay, chronic hypoxic and hypercapnic respiratory failure, neuromuscular weakness, and ineffective cough. He has tried and failed manual chest physiotherapy for airway clearance. The patient has had multiple hospitalization in the past 12 months for acute on chronic respiratory failure due to infective airway clearance leading to pneumonia. The patient has evidence of chronic atelectasis on chest radiology. The patient has neurostimulator device on the right chest wall, which prohibits the use of high frequency chest wall oscillation. The oscillation and lung expansion (OLE) device, Volara system, was prescribed for the patient. This was denied coverage by the health plan due to lack of medical necessity. This denial is being appealed.

The requested Durable Medical Equipment (Volara Device E1399) is medically necessary.

The patient has chronic respiratory failure due to developmental delay as well as neuromuscular weakness. The patient is not able to clear pulmonary secretions. The patient has tried and failed manual chest physiotherapy. The high frequency chest wall oscillation device is contraindicated due to a neurostimulator device on right chest wall. The effective pulmonary secretion clearance is necessary to prevent future infections as well as preserve lung function. The use of the Volara system has been associated with improved post-operative complications in high-risk surgical patients by improving pulmonary secretions and preventing atelectasis. The patient has tried and failed all current therapy. The use of the Volara system to improve pulmonary secretions clearance and atelectasis is medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Fatigue and altered mental status

Treatment: Acute inpatient rehabilitation services

The insurer denied coverage for acute inpatient rehabilitation services

The denial is upheld 

This is a patient who was seen in the hospital emergency department for ongoing fatigue and altered mental status. The patient was treated with intravenous (IV) antibiotics due to concern for bacterial encephalitis. The patient was subsequently treated with IV Acyclovir. Under review is the medical necessity of continued acute inpatient rehabilitation services. 

From a physical medicine and rehabilitation/pain management perspective, as well as within a reasonable degree of medical certainty, the clinical records do not support the medical necessity of acute inpatient rehabilitation. According to a provider progress note, the patient's mental status remained back to baseline. Acute rehabilitation was requested and subsequently provided due to the patient's reported inability to ambulate. No other rehabilitation therapy services (such as occupational therapy, speech therapy) were specifically warranted at that time. Physical therapy services could have been provided and more clinically appropriate at a lower level of care such as subacute rehabilitation or a skilled nursing facility. In addition, there were no acute medical or complicated nursing issues that required treatment in an acute rehabilitation medicine setting. 

Considerations include the clinical standards of the plan, the information provided concerning the patient, the attending physician's recommendations and applicable generally accepted practice guidelines developed by the federal government, national or professional medical societies, boards and/or associations. All decisions are evidence-based. 

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably, with sound medical judgment and in the best interest of the patient. The medical necessity for continued acute inpatient rehabilitation services is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Rule out cerebrovascular accident (CVA)

Treatment: Inpatient admission

The insurer denied coverage for inpatient admission

The denial is upheld

 
This case involves an adult who presented to the emergency department (ED) for right arm heaviness/numbness that started earlier that day. Computed tomography (CT) scan was ordered for stroke activation. It was noted that speech was clear, there was no facial droop, the patient moves all extremities and follows all commands. There was decreased sensation to light touch in the right upper extremity. Past medical history was significant for hypertension, hyperlipidemia, diabetes, coronary artery disease status post stents, history of cardiac arrest, mechanical valve replacement, and automated implantable cardioverter defibrillator. It was noted that the patient was not a candidate for tissue plasminogen activator (tPA) due to use of warfarin and lack of suspicion for large vessel occlusion. History and physical noted CT scan of the head revealed no acute pathology. CT perfusion was concerning for slight cerebral mismatch. Neurology was consulted. Discharge summary stated the patient was seen by neurology and cleared for discharge. It was noted that symptoms had resolved, and the patient was started on Lovenox as a bridge while international normalized ratio (INR) was subtherapeutic. The patient was advised to follow-up with cardiology and neurology as an outpatient for further care.

Milliman Care Guidelines (MCG) recommends inpatient care for patients with acute ischemic stroke when there are neurological findings or need for inpatient care/monitoring.  In this case, there was a lack of documentation of hemorrhagic transformation, altered mental status, dysphagia, significant arm/leg weakness, aphasia, gait impairment, hemodynamic instability, cardiac arrhythmias of immediate concern, or significant findings on brain imaging.  In this case, there was arm weakness, that resolved quickly. Imaging did not reveal any significant pathology. INR and additional treatment could have been addressed under observational care or as outpatient. Given the submitted findings, there is a lack of clinical evidence to support inpatient admission.  

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for a hospital admission is not substantiated.