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

Diagnosis: Intractable Hiccups
Treatment: Inpatient Hospital Admission
The insurer denied: Inpatient Hospital Admission
The denial is upheld.

This patient is an adult male who presented with shortness of breath due to intractable hiccups. This started after the patient had surgery for his abdominal aortic aneurysm (AAA). The 
hiccups started during the hospital stay for his abdominal aortic aneurysm repair and he was discharged with hiccups. The patient had tried home remedies without any relief. On the next day, the patient had no acute events overnight. The patient had hiccups that had lessened in severity. His breathing felt better but was starting to come back again. The patient was discharged on day #3 and was without hiccups in the morning. 

The proposed treatment was not medically necessary.

Inpatient hospital admission was not medically necessary since the patient did not require any procedural or surgical intervention, did not require to be nothing by mouth for a prolonged duration of time, and did not require prolonged treatment with intravenous hydration or intravenous medications. In addition, the patient did not have acute kidney injury, did not have electrolyte derangement needing intravenous replacement, did not have fevers, did not have an elevated white count, and did not have any complications such as intra-abdominal abscess or a surgical abdomen.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: foot pain
Treatment: HyProCure Sinus Tarsi Implant
The insurer denied HyProCure Sinus Tarsi Implant.
The health plan's determination is overturned. 

The patient is a female who underwent arthroereisis of the bilateral subtalar joints with HyProCure implants. Diagnoses of talotarsal dislocation of the left and right foot were rendered. No complications were noted.
A letter authored by the provider stated that prior to surgery, the patient had not responded to conservative care consisting of custom inserts and rest, and continued to have pain with activities. The provider noted that the patient's mother was not amenable to more extensive reconstructive surgery that carried a higher risk of potential complications. He notes the patient is doing well as have numerous other patients that underwent the same procedures.

The HyProCure Sinus Tarsi Implant is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
The implant has documented efficacy and the patient had not responded to standard measures.
The Hyprocure implant has achieved satisfactory curative effects with a low complication rate in flexible flat feet, as was present in this patient (1). A 5-year follow up study found that extraosseous talotarsal stabilization (arthroeresis) was effective in stabilizing the talotarsal joint complex and eliminating excessive abnormal pronation, thus reducing pain and improving quality of life of the patients (2). Recent literature has demonstrated the improved alignment of the foot with the use of the implant (3).
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: foot pain
Treatment: HyProCure Sinus Tarsi Implant
The insurer denied HyProCure Sinus Tarsi Implant.
The health plan's determination is upheld. 

The patient is a female who had pain and deformity affecting her left and right foot which had not responded to conservative care consisting of custom-made orthotics and rest. She was unable to walk or participate in weight bearing activities without pain. The patient underwent correction of talo tarsal dislocation with Hyprocure implant bilateral feet. 

The proposed Hyprocure sinus tarsi implant is not likely to be more beneficial than any standard treatment or treatments for the insured's condition. There are limited studies to support the use of the Hyprocure sinus tarsi implant. In the retrospective study, Graham et al determined the long-term functional outcomes and device tolerance achieved in adult patients who chose to undergo an extra-osseous talotarsal stabilization procedure Hyprocure for the treatment of flexible talotarsal joint deformity. This study had several major drawbacks; (a) 16 subjects underwent revision surgeries, (b) the effectiveness of the HyproCure device as a stand-alone procedure is unclear since 32% (percent) of the cases (35 of 110 feet in whom the implants were not removed) were performed with adjunctive procedures to achieve the desired amount of correction, (c) these researchers failed to quantify the improvement in terms of pre-operative subjective participant satisfaction scores.
Due to the limited studies and lack of established effectiveness of the procedure, the HyproCure is not indicated for this patient at this time. There is no evidence to support any benefit over any standard treatment or treatments.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: foot pain
Treatment: HyProCure Sinus Tarsi Implant
The insurer denied HyProCure Sinus Tarsi Implant.
The health plan's determination is upheld. 

The patient is a female with foot pain/deformity. The clinical documentation provided is sparse and consists only of a handwritten history and physical from the day of surgery. There are no pre-operative notes, radiology, evaluation or any follow-up. The pathology is described as bilateral foot pain secondary to talotarsal dislocation not responsive to conservative care. The recommendation was bilateral arthroeresis procedures in lieu of other surgical options.

HyProCure Sinus Tarsi Implant is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
Arthroeresis is a treatment for flexible flatfoot deformity, generally in the pediatric population that allows repositioning of the subtalar joint on a less permanent and more flexible way that subtalar arthrodesis or calcaneal osteotomies. It does not directly correct talonavicular pathology.
Reading the surgeon's appeal documentation, the literature supporting the procedure is not high quality. Series generally are small, retrospective and generally published in low impact journals. Though the data published is encouraging, better studies are needed to support widespread use of the technique.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Alzheimer's Disease
Treatment: Personal Care Aide (PCA) services 7 hours/day, 7 days/week, total of 49 hours/week
The insurer denied PCA services 7 hours/day, 7 days/week, total of 49 hours/week.
The health plan's determination is overturned.

This is a case review for a female with a medical history notable for Alzheimer's dementia, incontinence, and mobility issues. The patient and her care team requested an increase to 7 hours/day, 7 days/week, for a total of 49 hours/week. 

The patient's neurologist provided a letter of support for this appeal. The letter states that the patient has severe Alzheimer's dementia and is living with her husband who also has dementia. Because her husband's dementia has been worsening, he is not able to help as much. The patient's children are involved in her care, but both work full-time and cannot provide consistent informal support. The patient is no longer capable of performing any activities of daily living (ADLs) without assistance. She is almost unable to converse at this point and her speech is nonsensical. She is not able to walk on her own.


The requested health service of Personal Care Aide (PCA) services 7 hours/day, 7 days/week, total of 49 hours/week is medically necessary for this patient.

The patient requires personal care assistance for all ADLs. Her needs can be expected to be unscheduled and continuous throughout the day and occasionally at night as well. Her current hours are insufficient to meet her needs, particularly in light of her spouse's worsening functional condition and inability to provide informal support. If the patient is able to safely stay in her home with the additional hours, then the hours are medically necessary and appropriate for the patient. These hours are not simply for safety monitoring and security, as she does require frequent assistance with personal care needs throughout the day.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's disease. 
Treatment: Entyvio 300mg (milligrams) every 4 weeks under the medical benefit (Code J3380). 
The insurer denied Entyvio 300mg every 4 weeks under the medical benefit (Code J3380). 
The determination is overturned. 

This is a female patient with ileocolonic Crohn's Disease and primary sclerosing cholangitis. The patient has failed numerous previous anti-inflammatory, immune modulator, and biologic drugs. The patient is maintained on Entyvio 300 milligrams (mg) every (Q) 8 weeks. The patient underwent a colonoscopy which showed persistent but improved inflammatory changes in the right colon. The patient continues to endorse diarrhea, right lower quadrant (RLQ) pain and nausea. 
The patient's provider has recommended increasing Entyvio to 300 mg every 4 weeks. The rationale is that the standard dose is only partially beneficial, and the patient has ongoing active inflammation with symptoms. 
At issue is whether the proposed health service or treatment Entyvio 300mg every 4 weeks is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. 

The best data comes from a systematic review of real-world literature [1]. This systematic literature review (SLR) of real-world studies was conducted to assess the effectiveness of dose escalation from Vedolizumab every 8 weeks (Q8W) during maintenance treatment to achieve a response in patients who were either Vedolizumab responders experiencing secondary loss of response or non-responders. Overall, 196/395 (49.6 percent [%]) patients with inflammatory bowel disease (IBD) had a response within 54 weeks of Vedolizumab maintenance dose escalation. Clinical response rates after escalated Vedolizumab Q8W maintenance dosing ranged from 40.0% to 73.3% (9 studies) and from 30.0% to 55.8% for remission (4 studies) over a range of 8 to less than (<) 58 weeks' follow-up.
Expert consensus is that before abandoning Vedolizumab, if the patient is having a partial response, is to dose escalate to Q 4 weeks and assess the response. This is based on the fact that trough drug levels for Vedolizumab do correlate with efficacy. This patient may need a higher trough to achieve benefit. As a practical matter, the patient does not have much in the way of remaining choices to treat her disease.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's disease. 
Treatment: Entyvio 300mg (milligrams) every 4 weeks under the medical benefit (Code J3380). 
The insurer denied Entyvio 300mg every 4 weeks under the medical benefit (Code J3380). 
The determination is overturned. 

This is a female patient with Crohn's disease and primary sclerosing cholangitis. She has failed Mesalamine, Sulfasalazine, 6-Mercaptopurine, Infliximab, Adalimumab, and Stelara. A prior colonoscopy resulted in biopsies indefinite for colonic dysplasia. She started Entyvio with a huge improvement. A colonoscopy showed inflammation in the cecum, ascending colon, and transverse colon. Coverage is requested for Entyvio 300 milligrams (mg) every 4 weeks for the treatment of Crohn's disease. 
Current medical literature supports the request for Entyvio 300 mg every 4 weeks as likely to be more beneficial than any standard treatment or treatments for the patient's Crohn's disease. The patient's disease is severe given biopsies indefinite for colonic dysplasia, and she has failed all recommended primary therapeutic medication classes recommended by guidelines for the treatment of Crohn's disease. She is already on the standard dose of Entyvio [1,2]. In the randomized placebo-controlled Gemini 1 and 2 trials, which supported Food and Drug Administration (FDA) approval, it was part of the study protocol for patients who had not achieved remission by week 6 to continue Entyvio every 4 weeks rather than every 8 weeks [1,2]. In Crohn's disease, Entyvio every 4 weeks resulted in remission in over 36 percent (%) of patients after one year [2]. The Gemini long term study of 57 Crohn's disease patients who failed Entyvio every 8 weeks has reported increased remission rates with treatment every 4 weeks as well [3]. Studies have shown that insufficient Entyvio dosing can result in uncontrolled disease [4-6]. Additionally, the American College of Gastroenterology guidelines for the treatment of Crohn's disease state that "Those with continued symptoms should have their medication dose adjusted in order to attempt to optimize therapy" [4]. These data apply to this case, in which dose intensification is requested for Entyvio infusion every 4 weeks.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's disease. 
Treatment: Entyvio 300mg (milligrams) every 4 weeks under the medical benefit (Code J3380). 
The insurer denied Entyvio 300mg every 4 weeks under the medical benefit (Code J3380). 
The determination is overturned. 

This is a female patient who has severe ileocolonic Crohn's disease and primary sclerosing cholangitis (PSC). She has previously tried and failed an immunomodulator (6-MP), two anti-tumor necrosis factor (TNF) agents (Infliximab and Adalimumab) and an interleukin (IL) 12-23 inhibitor (Ustekinumab). Entyvio was started at 300 milligrams (mg) every 8 weeks in 2022. She initially responded but started losing response to every 8-week infusions. She had had active inflammation on a recent colonoscopy. Therefore, the attending Gastroenterologist would like to escalate the dose of Entyvio to 300 mg every 4 weeks to treat this patient's severe Crohn's disease. 
At issue is whether the proposed health service or treatment Entyvio 300 mg every 4 weeks 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 Entyvio 300mg every 4 weeks is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease. 
Although the standard of dose of Entyvio in both ulcerative colitis and Crohn's disease is 300 mg infused intravenously over approximately 30 minutes at zero, two and six weeks, then every eight weeks thereafter, the attending provider is requesting an Entyvio dose escalation with a shortened interval between infusions to every 4 weeks since the patient did not respond to Entyvio every 8 weeks. 
The concept of dose escalation in biologic therapy used in inflammatory bowel disease can be done either based on clinical symptoms or laboratory markers or endoscopic or radiological features with or without therapeutic drug monitoring. Dose escalation is done either by increasing the dose of the medication or shortening the interval between doses or sometimes a combination of both dose increase and shortening the interval between doses. There are only a finite number of biological agents used to treat inflammatory bowel disease and the standard of care is to optimize dose of the biological agent before switching to another agent. This patient has medically refractory Crohn's disease and has failed three other biological agents used to treat Crohn's disease. Therefore, it is indicated to use Entyvio 300mg intravenous (IV) every 4 weeks to treat this patient's severe Crohn's disease. This patient is not responding to the standard dosing of Entyvio 300 mg every 8 weeks.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Acute Cholecystitis

Treatment: Inpatient Admission

The insurer denied coverage for Inpatient Admission

The denial is upheld

Acute cholecystitis is also estimated to attribute to millions of ambulatory visits each year and is a leading cause of hospital admissions. [1] Studies have shown that ambulatory laparoscopic cholecystectomy is safe and avoids an overnight hospital stay. [2, 4, 5] Factors that contribute to admission after laparoscopic cholecystectomy include drain placement, conversion to open surgery, persistent abdominal pain, nausea, and vomiting. [3] In patients without abnormalities of the bile duct or abnormal liver function tests (elevated alkaline phosphatase (ALP) and total bilirubin), ambulatory laparoscopic cholecystectomy is safe and feasible. [5, 8] A 50% (percent) increase in the liver function tests can be labelled as mild elevation and is considered negligible by many. [9] Ambulatory and/or outpatient laparoscopic cholecystectomies reduce hospital costs without compromising patient outcomes. [6]

Per clinical documentation, this patient presented to the Emergency Department (ED) on with epigastric abdominal pain. Vital signs in the ED were within normal limits (WNL). The patient was afebrile. Abdominal ultrasound demonstrated cholelithiasis without findings of acute cholecystitis. White blood cell (WBC) count was normal at 7.1k (7.1 thousand). Liver function tests were elevated with alanine transaminase (ALT) 130, aspartate aminotransferase (AST) 55, and alkaline phosphatase (ALP) 185. The patient underwent a laparoscopic cholecystectomy. There were no reported complications. There is no further clinical documentation of a need for inpatient admission. Per Milliman Care Guidelines (MCG) criteria, admission is indicated when common bile duct obstruction is indicated via imaging and there are signs of systemic inflammation. [7] Peer-reviewed literature and MCG criteria indicate that inpatient admission is not necessary. Per provided clinical documentation, inpatient admission was not medically necessary. Observation status would be more appropriate. 

Case summary details

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 the inpatient admission is not substantiated
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: status/post laparoscopic nissen fundoplication 
treatment: inpatient stay
The insurer denied the inpatient stay
The health plan's determination is upheld. 

This patient is a female with history of hypertension (HTN), gastroesophageal reflux disease (GERD) who underwent a laparoscopic nissen fundoplication which was uncomplicated. On postoperative day (POD)#1 the patient underwent an upper gastrointestinal (UGI) which was normal, and the patient was able to tolerate a liquids and was discharged to home. 

The inpatient hospital admission was not medically necessary.
In general, uncomplicated laparoscopic fundoplication can be managed at a lower level of care given that there is no surgical anastomosis or stapling involved in the procedure. It is not on the inpatient only Centers for Medicare and Medicaid Services (CMS) procedure list.
The patient met criteria for a lower level of care as she was able to undergo the laparoscopic fundoplication and tolerate liquids, have stable vital signs and be discharged to home within a 23 hour observation period. The patient was not medically complex and there were no postoperative complications or complexity reported.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Osteoporosis
Treatment: Consumer Directed Personal Assistant Services (CDPAS) 24 hours/day (split shift)
The insurer denied CDPAS 24 hours/day (split shift).
The health plan's determination is overturned.

This is a case review for a male with medical history notable for heart disease, colostomy, rheumatoid arthritis, kidney failure, and incontinence. The patient and his care team requested Consumer Directed Personal Assistant Services (CDPAS) 24 hours/day (split shift).

The patient's physician provided a letter of support for this appeal. The letter states that the patient is wheelchair dependent due to ataxic gait. He has numerous medical problems as outlined above. He is homebound and bedbound. He has urinary incontinence and is unable to change diapers independently. He requires assistance with transfers and ambulation. The physician requests turning and repositioning every 2 hours to prevent bedsores. The patient lives alone. Therefore, the physician requests 24-hour split-shift care to assist the patient.

The requested CDPAS 24 hours/day (split shift) is medically necessary for this patient.

The patient was approved for live-in care, and the request is for split-shift personal care. Live-in personal care aides are expected to receive adequate rest each night, including at least one 5-hour window of uninterrupted rest. If the patient has care needs that would preclude the required rest periods, then split-shift care is deemed medically appropriate.
The notes state that the patient requires a one-person assistance for bed mobility every 2 hours throughout the day and night. He also requires frequent toileting and diaper changes as needed for incontinence. His care needs are continuous and unscheduled throughout the day and night. A live-in aide would not be expected to receive adequate rest. Therefore, the requested split-shift personal care is medically necessary and reasonable for the patient.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Diabetes mellitus, cognitive impairment, and autistic disorder
Treatment: Consumer Directed Personal Assistance Services (CDPAS) 60 hours/week
The insurer denied CDPAS 60 hours/week.
The health plan's determination is overturned.

This is a case review for a female with medical history notable for type 1 diabetes mellitus, cognitive impairment, and autistic disorder. The patient's mother provided a letter of support for this appeal. The letter states that the patient has cognitive impairment and difficult to manage blood sugars in the setting of type 1 diabetes. The mother needs to work and cannot tend to the patient at all times, but she says the patient requires 24-hour care. She states the patient has cognitive impairment with the mental capacity of a 4 year old and cannot calculate her own insulin requirements.

The requested Consumer Directed Personal Assistance Services (CDPAS) 60 hours/week is medically necessary for this patient.

The patient is receiving the number of hours recommended by the task tool, 44 per week. However, her care needs are pervasive and she requires continuous care. Her blood glucose measurement will occur throughout the day and on both a regular schedule and unscheduled basis. Other needs, such as toileting, will occur during unscheduled times as well. The patient's mother is providing informal support for most of the week, but she requires time away from her daughter to work and there is no other informal support in place for the patient. Therefore, the requested increase in personal care is medically necessary for the patient.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Crohn's disease
Treatment: Continued Infusion of Remicade (J1745)
The insurer denied: Continued Infusion of Remicade (J1745)
The denial is upheld.

The patient is an adult male with moderate to severe fistulizing Crohn's. He has been treated with Remicade 5 milligrams per kilogram (mg/kg) every eight weeks. Eight months ago, the patient lost response with increased bowel movements and bleeding. There were antibodies to Remicade. Remicade was increased to 5 milligrams per kilogram every four weeks with good results. However, as there is no tuberculosis (TB) quantiferon provided within the past year, Remicade was denied.

The requested service is not medically necessary.

It is standard of care to ensure that patients treated with biologics have a yearly tuberculosis (TB) quantiferon test, as treatment with biologics is associated with re-activation of latent tuberculosis. As this patient has not had a recent tuberculosis test provided, continuation of Remicade is not clinically appropriate or accepted standard of medical care. Therefore, without a negative tuberculosis test, the requested Remicade is not clinically appropriate, accepted standard of medical care, and is not medically necessary.