Persius/hicric huggingface dataset:
Appeal type: Formulary Exception
Decision: Upheld

The patient is a female with a history of coronary artery disease, ischemic cardiomyopathy and heart failure with reduced ejection fraction. By echocardiogram, her left ventricular ejection fraction was 37%. The subject under review is the use of the non-formulary drug Farxiga.

There are no high quality data indicating that the formulary alternative Jardiance would be less effective that Farxiga in this instance, or that it would have more adverse effects.
This patient has heart failure with reduced ejection fraction (HFrEF). Both Farxiga (dapagliflozin) and Jardiance (empagliflozin) are members of a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. In a large, multi-center placebo-controlled trial, 4744 patients with New York Heart Association class II, III, or IV heart failure and an ejection fraction of 40% or less were randomly assigned to receive either dapagliflozin (Farxiga) or placebo. Farxiga was associated with a significant decrease in the primary outcome which was a composite of worsening heart failure (hospitalization or an urgent visit resulting in intravenous therapy for heart failure) or cardiovascular death. Farxiga is Food and Drug Administration (FDA) approved to reduce the risk for cardiovascular death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction. In patients with HFrEF Jardiance (empagliflozin) has also been shown to lower the risk of cardiovascular death or hospitalization for heart failure as compared to placebo. Like Farxiga, It is FDA approved to reduce the risk of cardiovascular death and hospitalization in adults with heart failure with reduced ejection fraction (HFrEF). The two drugs have similar safety profiles; their most common side effects are urinary tract infection and vaginal yeast infection. At this point there have been no randomized trials directly comparing the two agents. While current guidelines endorse the use of an SGLT2 inhibitor in patients with HFrEF, they do not specify the use of one agent over the other.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Sjogren's Syndrome with Arthritis
Treatment: Rasuvo
The insurer denied: Rasuvo
The denial is: Upheld

The patient is a female with Sjogren's syndrome with arthritis. The issue in this case is Rasuvo is being denied by the health plan. The plan only covers Rasuvo if the patient is unable to give the generic injections to themselves. The patient's prior treatment includes oral methotrexate (MTX), which she was unable to tolerate due to gastrointestinal (GI) side effects. Prior treatment also includes Plaquenil, prednisone, Cymbalta, Mobic, diclofenac, and gabapentin. The subject under review is the medical necessity for Rasuvo for this patient.

Rasuvo is not medically necessary. There is no medical reason she cannot try the generic subcutaneous (SQ) methotrexate which is the plan preferred drug.
The patient has Sjogren's and the main issue at present is ongoing arthritis. She has already tried oral MTX (unable to tolerate due to GI side effects), Plaquenil, prednisone, Cymbalta, Mobic, diclofenac and gabapentin. A trial of SQ MTX is very reasonable to treat her arthritis but she does not have a contraindication or side effect to generic SQ MTX. A study in Arthritis and Rheum in 2008 looking at patients with rheumatoid arthritis (RA) on MTX, concluded that, "this 6-month prospective, randomized, controlled trial is the first to examine oral versus SQ administration of MTX. We found that SQ administration was significantly more effective than oral administration of the same MTX dosage. There was no difference in tolerability."
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Gastroesophageal reflux disease (GERD)
Treatment: Procedure code 43284 (LINX Reflux Management System)
The insurer denied coverage for procedure code 43284 (LINX Reflux Management System)
The denial is overturned

The patient has chronic esophageal reflux and has been on both pantoprazole and famotidine. A barium esophagram showed moderate mid-thoracic gastroesophageal reflux. An endoscopy showed only a small hiatus hernia. A reflux monitoring study showed a DeMeester score of 63 (normal under 14.7). His physician has recommended proceeding with the LINX Reflux Management System. 

The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) conducted an updated Safety and Effectiveness Analysis of the Linx Reflux Management System in March 2017. With regards to safety, the conclusion was that long-term follow-up supports the Food and Drug Administration (FDA) conclusion that the device is safe. With regards to efficacy there were several conclusions. The LINX implant results in hydrogen potentials (pH) normalization, improved quality of life, and cessation of regular proton pump inhibitors (PPI) use on a consistent basis. When compared to laparoscopic fundoplication, rates of success in alleviating gastroesophageal reflux disease (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. 

The Annals of Surgery 2019 Aug 270(2):302-308 has an article titled "Objective Evidence of Reflux Control After Magnetic Sphincter Augmentation: One Year Results From a Post Approval Study." The conclusion was that both safety and effectiveness of magnetic sphincter augmentation has been demonstrated outside of an investigational setting to further confirm the procedure as treatment for GERD. 

The scientific literature supports the use of the LINX system as a treatment for GERD. The 2019 study in the Annals of Surgery confirms the long term safety and efficacy of the procedure. The LINX system has been approved by the FDA, The patient is a good candidate since he has chronic GERD and has concerns about long term PPI therapy. There are multiple options for treating GERD, but the LINX system has been shown to be both effective and safe. The procedure has been shown to be beneficial for chronic reflux. 

In summary, the denial of procedure code 43284 (LINX Reflux Management System) and coverage for the requested treatment should be overturned. This treatment is likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are not substantially increased over standard treatments.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Dry Eye Syndrome.
Treatment: Formulary exception for Cequa.
The insurer denied: Formulary exception for Cequa.
The denial is upheld.

The patient is an adult female with dry eyes for whom coverage of Cequa (cyclosporine) 0.09% is the subject of review. Coverage was previously denied by the health plan, as it was not identified that the patient had failed or could not use the formulary alternative, Xiidra. The provider states that the patient can only use preservative-free medications, and Cequa is the only dry eye drop that is preservative free. The patient has tried and failed multiple preservative-free artificial tears. The provider states that Restasis and Xiidra are not preservative free.

The health plan should not cover the Formulary exception for Cequa.

It is not identified that the formulary drug, Xiidra, would be or has been ineffective or caused adverse effects for this patient. The requested non-formulary drug, Cequa, is not identified as more effective than the formulary drug Xiidra. The Preferred Practice Patterns of the American Academy of Ophthalmology recommends the use of topical cyclosporine (Restasis, Cequa) or lifitegrast (Xiidra) for the treatment of moderate to 
severe dry eye syndrome in patients who have demonstrated inadequate response to ocular lubricants, as in this case. A review of the peer-reviewed medical literature does not identify Cequa as being safer or more effective than the formulary alternative, Xiidra. It is noted that Cequa ophthalmic solution is packaged in sterile, preservative-free, single-use vials. Restasis Multidose is also identified as being preservative free. Similarly, Xiidra (lifitegrast ophthalmic) does not contain preservatives and is packaged for one-time use in individual doses, eliminating the need for preservatives.
Therefore, given the above, the health plan should not cover the formulary exception for Cequa.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Dental caries
Treatment: Nerve treatment and post on teeth 3, 4, 7, 10, 12, 13, and crown on teeth 2, 3, 4, 7, 8, 9, 10, 12, 13, 15, 29, and 30
The insurer denied coverage for nerve treatment and post on teeth 3, 4, 7, 10, 12, 13, and crown on teeth 2, 3, 4, 7, 8, 9, 10, 12, 13, 15, 29, and 30
The denial is upheld

 
Upon review of the submitted documentation which includes copies of full mouth series radiographs and insurer correspondence, it appears that this patient presented to the dentist for evaluation and comprehensive dental treatment. Based on the documentation, multiple endodontic procedures and post and crowns were recommended for multiple teeth in all 4 quadrants. The insurer has denied the services stating that these services are not medically necessary treatment as the clinical documentation does not support it, and further there is extensive decay, and high risk of new decay. The patient is appealing. 

Based on the submitted information for review, particularly the radiographic examination, there is evidence of multiple carious teeth; however, there does not appear to be any caries or odontogenic or periodontal pathology on numerous additional teeth that the doctor has recommended for treatment. The clinical and radiographic documentation do not support the extensive dental treatment recommended by the dentist. There are no dental treatment notes, no dental charting, nor periodontal charting provided for review. As the documentation is inadequate to support the treatment, these services are considered not medically necessary.

Uphold denial for nerve treatment and post on teeth 3, 4, 7, 10, 12, 13 and crown on teeth 2, 3, 4, 7, 8, 9, 10, 12, 13, 15, 29 and 30 as the provided documentation for review is inadequate and did not support the extensive treatment recommended.

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 nerve treatment and post on teeth 3, 4, 7, 10, 12, 13, and crown on teeth 2, 3, 4, 7, 8, 9 ,10, 12, 13, 15, 29, and 30 is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Cataract
Treatment: Extracapsular Cataract Removal with Insertion of Intraocular Lens Prosthesis at a Hospital (or Hospital Clinic)
The insurer denied Extracapsular Cataract Removal with Insertion of Intraocular Lens Prosthesis at a Hospital (or Hospital Clinic).
The health plan's determination is overturned. 

The patient is a woman with a history of bilateral retinal detachments status/post (s/p) repair and cataract surgery in the left eye now with cataract surgery in the right eye. The patient had preoperative vision of 20/50 best corrected with nuclear sclerosis and posterior subcapsular cataract in the right eye. 

Extracapsular Cataract Removal with Insertion of Intraocular Lens Prosthesis at a Hospital (or Hospital Clinic) is medically necessary for this patient. The patient met the criteria for standard of care for removal of cataracts. She had it done at an outpatient facility. The facility uses the word hospital in it's name, but it is not a full service hospital.
The patient met all standards of care for cataract removal with insertion of intraocular lens. She had blurred vision, she had a cataract, she had ongoing ocular health issues that require monitoring. These are all reasons that are standard of care for removing a cataract.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Foreign Body Ingestion. 
Treatment: Inpatient hospital stay. 

The insurer denied coverage for inpatient hospital stay. 

The denial is overturned. 

This an adult patient who felt that they had a chicken bone in the throat. The patient was seen in the emergency room. At that time, the patient had severe (9/10) pain from the left side of the throat and no other signs or symptoms of a foreign body. A Computed Tomography (CT) was obtained the same day which showed: "...adiopaque density in the upper esophagus at the level of the thyroid gland suspicious for a foreign body... 

The patient was admitted and a flexible Iaryngoscopy was performed which found no masses or lesions visualized in post cricoid space or pyriform sinuses bilaterally. A repeat CT was conducted the following day which showed that the foreign body was now in the small intestine. The patient was discharged. 

The morbidity and mortality associated and need for intervention of esophageal foreign bodies is well documented in the peer reviewed literature. The data justifies the sequence of diagnostic procedures which the patient underwent. The initial CT showing the foreign body in the esophagus, then a direct fiberoptic laryngoscopy which was not able to visualize the foreign body and the subsequent CT which showed that it had passed into the small intestine. 

The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. 

The patient presented the emergency room with severe (9/10) pain from the left side of the throat (airway) which the patient felt was due to a chicken bone. This sign is consistent as an indication for inpatient admission. The peer reviewed literature justifies the need for diagnostic procedures to determine if an invasive procedure may be warranted to remove the foreign body. As an invasive procedure would be required the inpatient hospitalization should be conducted expeditiously which justifies the inpatient admission. 

The inpatient hospital stay is considered medically necessary for this patient as the patient required to be monitored and to undergo a series of evaluations which could have resulted in the need for an urgent invasive procedure. 

The denial should be overturned as the inpatient admission was justified by the disease and was in accordance with Milliman Care Guidelines criteria. 

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

The medical necessity for inpatient hospital stay is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Shoulder Pain
Treatment: Right arthroscopic rotator cuff repair
The insurer denied the right arthroscopic rotator cuff repair.
The denial is upheld.

The patient is an adult male. The patient had shoulder pain complaints and had a right shoulder arthroscopic rotator cuff repair. The patient had complaints of chronic right shoulder pain. This began 2 years ago. The patient had the diagnosis of calcific tendinitis. The patient also had a type 3 slap (superior labrum from anterior to posterior) tear. The patient had an arthroscopic decompression of the type 2 acromion and bursitis. A biceps tenodesis was not performed. The patient had excision of the calcification measuring approximately 0.8 cm (centimeters) on MRI (magnetic resonance imaging) imaging. After debridement, there was an area of rotator cuff damage, and the tendon was repaired. This is a review for the rotator cuff repair.

The right arthroscopic rotator cuff repair was not medically necessary.

The rotator cuff repair, as done in this case, is inclusive to the excision of the calcific tendinitis. This would not be a separate operative procedure, since the CPT (Current Procedural Terminology) code for the excision of the calcific focus would include the repair of the tendon as necessary. Thus, the separate procedure code for the rotator cuff repair would not be medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Ulcerative Colitis. 
Treatment: Simponi at a dose of 200 milligrams (MG), 2 syringes per month. 

The insurer denied: Simponi at a dose of 200 milligrams (MG), 2 syringes per month. 
The denial is overturned. 

The patient is an adult female with indeterminate colitis, treated as ulcerative colitis. She has done well on Simponi 10 milligrams (mg) every four weeks for the past 6 years. Recently, the patient lost response, with increased symptoms at two weeks. Serum Simponi levels were low. The physician is requesting to increase Simponi to 200 milligrams (mg) every four weeks. 

The proposed treatment is medically necessary. 

Medical literature supports dose intensification of biologics in patients who have some but not a complete response to Food and Drug Administration (FDA) approved dosing. It is preferred to dose intensify before changing to another biologic agent. This is especially the case when serum drug levels are low. As this patient has had some, but then lost response to Simponi 100 milligrams every four weeks, with low serum Simponi levels, the request to increase Simponi to 100 milligrams every two weeks is clinically appropriate and accepted standard of medical care and is medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Cellulitis
Treatment: Inpatient Hospital Stay
The health plan denied: Inpatient Hospital Stay
The determination is: Overturned

The patient is a female who was admitted to the hospital for cellulitis. She has a history of recurrent cellulitis, obstructive sleep apnea (OSA), obesity, lymphedema, and chronic kidney disease. On presentation, the patient had worsening redness and swelling of the right lower extremity. She was started on intravenous (IV) antibiotics and was seen by infectious disease. She was referred to a lymphedema clinic. Her electrolytes were replaced, and her home diuretics were started. Her condition eventually improved, and she was discharged on oral antibiotics after infectious disease deemed it was appropriate.
At issue is the medical necessity of the inpatient hospital stay.
The health plan's determination of medical necessity is overturned in whole.
The requested health service/treatment of inpatient hospital stay was medically necessary for this patient. According to Liu et al., (2011), Stevens et al., (2014), and Raff et al., (2016), the patient had severe and refractory cellulitis that required a longer than normal IV antibiotic course before improving. She eventually was transitioned to oral antibiotics for her refractory cellulitis. Due to her complex case, an alternate level of care would not have been appropriate.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Obesity

Treatment: Surgical Procedure on Stomach

The insurer denied coverage for Surgical Procedure on Stomach

The denial is upheld
 

It was noted the patient was in the process of obtaining medical clearance for weight loss surgery. She had undergone 6 months of supervised weight loss. She has undergone psychology, nutrition, and pulmonary clearance. The Body Mass Index (BMI) at this visit was 35.71. The plan was laparoscopic distalization of bypass.

Upper gastrointestinal (UGI) endoscopy was done where it was noted that she had a Roux-en-Y Gastric Bypass (RYGB) with healthy appearing mucosa. There was no mention of a dilated pouch or stricture.

Based upon the evidence provided, this patient has had a previous gastric bypass and had a significant amount of weight loss. She does not appear to have any complication related to the gastric bypass such as a dilated gastrojejunostomy anastomosis or stricture. There is no mention of her not having a feeling of satiety. She is now seeking revision of the bypass to increase the weight loss. Her BMI is currently around 35 and there is no indication for revision other than she wants to increase her weight loss. This in itself is not an indication for a revision of the bypass. She has done well in the past from her gastric bypass and has maintained weight loss and does not appear to have any significant weight gain in the recent past. In fact, by following with the nutritionist she was able to lose a few more pounds. It is true that she underwent a complete multidisciplinary evaluation. However as noted by the insurer she does not meet criteria for revision with distalization given that there is no indication of a complication from her bypass. She did have an Esophagogastroduodenoscopy (EGD) where it was not noted that she has a dilated pouch or stricture. Thus, given these findings she does not meet the criteria for revision surgery.

In this case there is no evidence of dilation of gastrojejunostomy anastomosis or a dilated pouch. It does not appear that she is actually gaining weight as she her BMI has been stable around 35. Revision surgery should not be approved in this case.
	
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 inpatient admission and for Surgical Procedure on Stomach is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Appendicitis
Treatment: Inpatient Hospital Stay.
The insurer denied Inpatient Hospital Stay.
The determination is overturned in whole.

This patient presented to the emergency department with one day of right lower quadrant pain and a low-grade fever. The patient denied vomiting and diarrhea. The vital signs were within normal limits. The patient appeared well hydrated and had right lower quadrant tenderness with rebound tenderness. An ultrasound showed a complex fluid-filled structure, a possible abscess. A computed tomography (CT) scan showed an inflamed appendix with some fluid but no obvious perforation or abscess.

The patient was made nothing by mouth (NPO), started on intravenous (IV) fluid and antibiotics. The patient underwent laparoscopic appendectomy, which found a perforated appendix with pus in the abdomen. The patient was started on antibiotics post-operatively while hospitalized and discharged home on oral antibiotics to complete treatment of perforated appendix. At issue is the medical necessity of the inpatient stay.

The health plan, in its determination of medical necessity, did not act reasonably, with sound medical judgment and in the best interest of the patient.

The requested health service/treatment of full hospital admission was medically necessary for this patient. The patient had a surgical condition, appendicitis. Although, under certain circumstances, medical rather than surgical management (intravenous (IV) antibiotics, followed by oral antibiotics) may be offered to the patient. Appendicitis is an urgent rather than emergent condition. One does not need to go to the operating room immediately, and it is considered standard of care to operate on appendicitis patients after they have had their fluid status corrected, had intravenous (IV) antibiotics started, and been nothing by mouth (NPO) for a suitable amount of time. It is typical for a patient with acute appendicitis who gets admitted to the hospital in the late afternoon or early evening to have the operation the next day, which is what occurred in this patient.

Furthermore, the appendix was perforated, which typically leads to continued, post-operative treatment with intravenous (IV) antibiotics, and variation in when oral intake starts again. The recommended duration of intravenous (IV) antibiotics and the timing of initiation of oral intake is an individualized decision, which depends on the severity of the perforation and peritonitis, if any, as well as the patient's pain management and ability to tolerate oral intake. 

It is uncommon for patients to remain hospitalized for several days or even a week post-operatively for management of perforated appendicitis. This patient was unusual in their prompt post-operative recovery and early discharge home from surgery for a perforated appendix. As such, the days hospitalized were medically necessary.