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

This is a female patient with a history of mitral valve prolapse syndrome with mitral valve repair and several embolic events involving her left hand. Extensive work up was preformed that included telemetry monitoring whip was negative for atrial fibrillation, laboratory work up for hypercoagulable state which was negative and a transesophageal echocardiogram which revealed a right to left shunt. She was treated with anticoagulant therapy and recommendation was made for a percutaneous closure. 

Closure of a PFO with right to left shunt in a patient with recurrent arterial embolic events and no other etiology that clearly explains arterial emboli would be considered more beneficial for a patient than any other therapy. In a meta-analysis of five randomized clinical trials including over 1800 patients, patent foramen ovale closure reduced recurrent stroke or TIA compared with medical therapy.(1) Several randomized clinical trials support the use of transcatheter PFO closure in patients that have no other obvious etiologies for that may cause thromboembolic events. These trials have demonstrated a significant reduction in thromboembolic events and stroke in patients that undergo PFO closure as compared to those treated with anti-thrombotic medication alone(References 2-3).

The carrier's denial of coverage for the requested heart procedure (closure of a patent foramen ovale) should be upheld.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Patent Foramen Ovale
 
Treatment: Percutaneous Closure of the Patent Foramen Ovale

The insurer denied the Percutaneous Closure of the Patent Foramen Ovale. The denial was upheld.  

This is a female patient with a history of patent foramen ovale, mitral valve prolapse with a mitral valve repair and arterial embolization. She presented to the hospital with complaints of pain in her left middle finger. Cardiovascular surgery consulted the patient and determined that it was consistent with arterial embolization. She underwent an extensive work up that included a transesophageal echocardiogram which revealed significant right to left intracardiac shunting. Recommendations were made for percutaneous closure of her patent foramen ovale. 

The use of PFO closure is likely to be more beneficial than any other standard treatment or procedure.  Although the patient has not experienced a cerebrovascular accident or transient ischemic attack, she has, in fact, experienced the equivalent of an arterial embolization across her patent foramen ovale (PFO). Left untreated, and given she's already had one embolic event, she is at extremely high risk for future embolic events, which may result in stroke. The fact she has not had a stroke or TIA, but rather an arterial embolization to her left middle finger, is fortuitous for the patient, but demonstrates why PFO closure is appropriate for this indication. 

The carrier's denial of coverage for the requested heart procedure (closure of a patent foramen ovale) should be reversed.
Appeal type: Experimental/Investigational
Decision: Upheld

Reviewer #3:

This patient underwent a skin biopsy as ordered. The pathology report revealed malignant melanoma, approximately 0.7mm in thickness. Per the report the DecisionDx Melanoma class was 1, sub-class was 1A. Class 1A molecular signature is associated with the lowest risk of recurrence within 5 years. In patient 55 years and older with T1-T2 tumors, a class 1A result is associated with low probability of a positive sentinel lymph node.  

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome. The Decision DX Melanoma assay results of the DecisionDX Melanoma test revealed the patient as class 1A, which suggests a very low risk of metastatic potential. Furthermore, based on the results of the original biopsy and clinical findings, this testing would not be of value in treatment planning for this patient.

The DecisionDX Melanoma assay is not known to be effective based on a lack of scientific evidence showing that the results will accurately guide patient care and health outcomes. In this case, the testing would not have been considered effective or useful in treatment planning. The initial evaluation for risk of metastasis in patients with cutaneous melanoma uses the American Joint Committee on Cancer (AJCC) staging criteria, which includes Sentinel Lymph Node status. Per Trotter, S. C., Sroa, N., Winkelmann, R. R., Olencki, T., & Bechtel, M., (2013), "The stage at presentation of melanoma has a significant impact on the course of the disease. Most melanoma patients present with localized disease 82 to 85 percent of the time, followed by regional involvement 10 to 13 percent of the time, and distant metastatic disease 2 to 5 percent of the time. The staging of melanoma holds prognostic value and dictates the recommendation in treatment..."

In this case, the DecisionDX Melanoma assay was not known to be effective on date of reading based on a lack of scientific evidence showing that the results would accurately guide patient care and health outcomes, and the use of this testing was not supported by scientifically based guidelines of national medical research or governmental agencies. Furthermore, based on the results of the original biopsy and clinical findings, this testing would not be of value in treatment planning for this claimant.

The genetic testing for melanoma does not need/have final approval from the appropriate regulatory bodies for this diagnosis. This patient is not a good candidate for genetic testing for melanoma provided.     

The genetic testing for melanoma provided is not the best available treatment for this patient at this time.  This testing would not be of value in treatment planning for this patient as the scientific evidence does not support. The requested service is not likely to be more beneficial than any of the standard treatments/procedures for this patient.                                             

The carrier's denial of coverage for genetic testing for melanoma provided should be upheld.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Malignant melanoma
 
Treatment: Genetic testing for melanoma

The insurer denied coverage for genetic testing for melanoma. The denial is upheld. 

Reviewer #1:

This patient is a female that has had Decision Dx Melanoma testing for a melanoma in situ on the left side of her neck. The patient did have another malignant melanoma in situ (MMIS) on right deltoid. Decision Dx Melanoma has not had sufficient testing prospectively and in a randomized controlled study to make it standard of care.  Therefore, the scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome.

Per Abbasi et al. (2015), "Clearly, the greatest potential benefit is in those patients with intermediate risk melanomas (Stage I and II) as there is no consensus on how to manage them. In a study conducted by Pedram Gerami, MD, Associate Professor in Dermatology, Pathology, and Pediatrics-Dermatology at Northwestern University Feinberg School of Medicine, as compared to having a high-risk AJCC score a Class 2 GEP score has been shown to be 1.5 times more likely to have a poor outcome..." According to Boland & Gershenwald (2016), "The revisions to the American Joint Committee on Cancer (AJCC) melanoma staging system over time reflect changes in our understanding of the biology of the disease. Since the 1st edition, where tumor thickness was defined anatomically by its relationship to the reticular or papillary dermis (Clark level) as well as tumor thickness (Breslow thickness), there have been significant strides in our use of clinicopathological variables to stratify low- versus high-risk patients..."

As the DecisionDx Melanoma assay has not had sufficient testing prospectively and in a randomized controlled study to make it standard of care; therefore, the test was experimental/investigational and not medically necessary. The genetic testing for melanoma provided does not have final approval from the appropriate regulatory bodies for this diagnosis. The test is not certified by any regulatory body. This patient is not a good candidate for genetic testing for melanoma provided. The genetic testing is not the best treatment for the patient based on current guidelines. Therefore, genetic testing for melanoma provided is not the best available treatment for this patient at this time.     

There is no evidence that the Decision Dx test will benefit the patient over any other treatments.                                                    

The carrier's denial of coverage for genetic testing for melanoma provided should be upheld.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Gunshot Wound
 
Treatment: Inpatient Admission

The insurer denied the Inpatient Admission. The denial was upheld.

This is a female patient who presented to the emergency room with complaints of a gunshot wound to her right temple. The patient was alert and oriented x3 and reported having no loss of consciousness; a right temple hematoma was noted.  She was consulted by trauma surgery. On exam she had a right temple hematoma which was not rapidly expanding. There were no neurologic focal deficits. The assessment was GSW to right temple which appears stable. The CT of the brain showed no bleeding in the brain and that the wound appears to be superficial. Morphine was administered for pain. The patient experience no neurological focal deficits and the hematoma remained stable. The patient was safely discharged home.  

Trauma surgery recommended washing out the wound and providing wound care instructions and administering Morphine for pain. During the hospitalization the patient remained hemodynamically stable and neurologically intact, the hematoma remained stable and there was no significant change in size. The care plan was implemented, and the patient was discharged in stable condition. Based on the notes sent to the insurer, the care could have been given in the ED or in the observation area. Guidelines used were MCG 22nd edition: traumatic brain injury, non-surgical treatment ORG: M-78 (ISC).

Based upon the information provided, the hospital inpatient admission is not approved as the patient could have been managed in an observation status. The patient was status post superficial GSW to the right temple and did not have loss of consciousness. On exam radiologically she was found to have no intracranial bleeding. The Trauma Surgeon evaluated her and felt the patient needed to be observed. Thus, this patient did not need anything more than observation and not an acute inpatient admission.  

According to Milliman Care Guidelines Traumatic Brain Injury, Nonsurgical Treatment: Observation Care Inpatient And Surgical Care 23rd Edition: ORG: OC-063 (ISC) observation may be appropriate for patient with head injury and 1 or more of the following: vital signs abnormality; altered mental status; temporary loss of consciousness at time of injury; suspicion for vascular injury (e.g., penetrating injury, soft tissue swelling of the anterior neck); dizziness or vomiting beyond immediate post injury period; Posttraumatic seizure, etc.

Based upon these criteria the patient did not have any focal signs on neurologic exam as well as no evidence of worsening neurologic function or altered mental status that was severe or persistent.  She had none of the criteria listed to warrant admission but rather only observation level of care.

The carrier's denial of coverage for the inpatient hospital services is upheld. The medical necessity is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Right Hip Labral Tear
 
Treatment: Physical Therapy Services

The insurer denied the Physical Therapy Services. The denial was upheld.  

This is a male patient who was status post slip and fall injury resulting in severe pain in his groin area with weakness in his right lower extremity. The patient stated that since the injury, he had severe pain and discomfort in the groin area. The patient underwent an orthopedic consultation. It was reported that he was ambulating with cane. On physical exam he was noted to have 90 degrees of flexion with pain, internal rotation of 10 degrees with pain, and external rotation of 30 degrees with pain with positive Faber's test. The patient had an antalgic gait. He had a magnetic resonance imaging (MRI) that revealed an anterosuperior labral tear. Upon his initial physical exam with physical therapy he was noted to have moderate to severe limitation with right hip movements and he was experiencing difficulty weight bearing on his right leg. A single tip cane was implemented to reduce pressure on his right leg. He attended physical therapy as ordered. The insurer partially overturned the denial of physical therapy services. 

It was stated that the clinical documentation did not support the medical necessity for services beyond the last visit.  The patient is male who had a slip and fall injury with right hip weakness and labral tear.  He underwent a course of physical therapy three times a week for four weeks, which is a reasonable time period for rehabilitation, and the patient was noted to be ambulating independently with a one-prong cane.  

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

The carrier's denial of coverage for the physical therapy services is upheld.  The medical necessity is not substantiated.
Appeal type: Experimental/Investigational
Decision: Overturned

Reviewer #2:

This patient is a female with persistent reflux symptoms on medical therapy. There is growing sufficient published peer-reviewed data from well-constructed clinical studies to permit a scientific conclusion regarding the benefit of laparoscopic magnetic sphincter augmentation procedure for the treatment of GERD using the (CPT) code 43284 (laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of sphincter augmentation device) as an alternative the Nissen surgical approach. 
The LINX Reflux Management System (a sphincter augmentation device) (Torax Medical, Shoreview, MN) is used, according to the FDA, "to treat gastroesophageal reflux disease (GERD) in patients who continue to have GERD symptoms despite the use of maximum medical therapy for the treatment of their reflux." Note there is a lack of notable large trials for the surgical treatment of GERD and other indications.

From UpToDate; "In 2013, the US Federal Drug Administration (FDA) approved the LINX Reflux Management System for lower esophageal sphincter augmentation. Eligible patients for the procedure include those with inadequate symptom control with acid suppression therapy, including those patients with mild to moderate GERD and a hiatal hernia less than 3 cm. The device is a ring made up of a series of rare earth magnets that have sufficient attraction to increase the LES closure pressure, but allow for food passage with swallowing. Results from early studies at four years are encouraging. Based upon a prospective study that included 44 patients, the mean total percent time pH <4 was reduced from 11.9 percent at baseline to 3.8 percent at three years (p<0.001). Most patients at >=4 years of observation experienced improved quality of life and complete cessation of the use of PPIs." 

After review of the clinical records, medical history, and physical examinations, supporting information, Plan provisions, and relevant guidelines and literature, the (CPT) code 43284 (laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of sphincter augmentation device) is likely to be more beneficial than any standard treatment or procedures as there are unique clinical circumstances, such as failure to medical therapy, to this particular individual.

The insurer's denial of coverage for the LINX Reflux Management System should be reversed. This is the best available treatment for this patient who has failed medical management. The Schatzki ring is non-obstructive.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: GERD
 
Treatment: LINX Reflux Management System

The insurer denied coverage for LINX Reflux Management System. The denial is reversed. 

Reviewer #1:

This patient is a female with persistent reflux symptoms on medical therapy. Bravo ph testing showed a demeester score of 35. An endoscopy revealed reflux esophagitis with ulceration. In March 2017, The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) conducted an updated safety and effectiveness Analysis of the LINX Reflux Management System with regards to safety, the conclusion was that long-term follow up supports the FDA conclusion that the device is safe. With regards to efficacy, there were several conclusions. The LINX implant result in PH normalization, improved quality of life, and cessation of regular proton pump inhibitor (PPI) use on a consistent basis when compared to laparoscopic fundoplication, rates of success in alleviating GERD symptoms and dysphagia are similar following LINX. The long-term follow up data demonstrates that the LINX Reflux Management System is effective in the Management of GERD.

Based on the recommendation of SAGES it has been shown that LINX results in improvement in health outcomes LINX  does have FDA approval since the patient has persistent reflux symptoms she is a good candidate for the procedure. There are several options for both surgical and endoscopic treatment, but LINX has been shown to be an effective treatment. A minimally invasive treatment such as LINX is appropriate for patients who have continued reflux symptoms on medical management and do not want to have extensive surgery. The LINX procedure is likely to be more beneficial than any other standard treatments or procedures.

The insurer's denial of coverage for the LINX Reflux Management System should be reversed.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Mild Maxillary and Mandibular Crowding, Excessive Overjet, and Anterior Crossbite
 
Treatment: D8080 Braces

The insurer denied the D8080 Braces. The denial was upheld.

This is a patient who consulted an orthodontist for orthodontic treatment. Lateral cephalometric radiographs, panoramic radiograph, montage of extraoral and intraoral clinical imaging and a Handicapping Labio-Lingual Deviation (HLD) index was performed.

Upon review of the submitted documentation, it is evident that the patient exhibits a significant malocclusion.  However, to assess for severity of the malocclusion and therefore medical/dental necessity for orthodontic care, New York State requires, as of September 1, 2012, the use of an orthodontic Index, the Handicapping Labio-Lingual Deviation Index Report (HLD, New York State Medicaid program) modeled after Handicapping Labiolingual Deviation Index.  This index provides six specific conditions that automatically qualify for orthodontic care.  Additional criteria are used utilizing a point system if none of these initial qualifying conditions are met or selected.  For these other secondary criteria to qualify for orthodontic care, a total score of 26 points is necessary. 

In this case, the treating orthodontist claims an automatic qualifying condition of crossbite of individual anterior teeth when clinical attachment loss and recession of the gingival margin are present.  This reviewer finds that this automatically qualifying condition criterion is not met and does not support comprehensive orthodontic care.  In this case, the clinical circumstance does not meet insurer and plan criteria to justify orthodontic care.  This reviewer concurs with the HLD index of the insurer attaining 16 points (7 points overjet, 2 points overbite, 5 anterior crowding and 2 points labiolingual spread).

Regarding the validity of the Handicapping Labiolingual Index, it has been shown through scientific scrutiny in peer reviewed journals that this methodology for assessing orthodontic need is a valid approach.  This is confirmed by several studies including:

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

The carrier's denial of coverage for D8080 braces is upheld.  The medical necessity is not substantiated.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Opioid dependence
Issue under review: Formulary exception for Lucemyra

Determination:
The health plan should not cover the Formulary exception for Lucemyra.

The case involves a young adult male with a diagnosis of opioid dependence with withdrawal (F11.23). The health plan received a request for authorization for treatment with Lucemyra (lofexidine) tabs.

The health plan has denied authorization for the requested medication which is a formulary exception. Alternative treatments are available and have not been clearly tried and failed in order to approve a formulary exception. 

Formulary alternatives are available to address the patient's opioid use disorder and opioid withdrawal symptoms. There is no evidence that the requested medication, Lucemyra, is more beneficial than formulary alternatives that include buprenorphine and clonidine used as clinically appropriate. Thus, based on the submitted information, the requested formulary exception for Lucemyra is not reasonable in this case scenario and should not be covered for this patient.

This answer is consistent with the guidelines and scientific literature, referenced below, and consistent with the instructions for this mandated NY State Review.