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

This is a patient who was diagnosed with autistic disorder, mixed incontinence, developmental and motor delay, speech delay, and lack of social skills. She is described as having no functional limitations. She is able to walk independently. She is not self-directing. She is not able to summon help. She is continent of bladder, but not of bowel. She is on no medications. She is on a regular diet. No skilled monitoring is required for vital signs, dressing changes or monitoring of blood glucose. She receives speech therapy 3 times a week, and occupational therapy twice a week. She lives with her parents and older brother. Her father is employed full-time out of the home. Her mother works part-time from home. 

At issue is whether the requested health service/treatment of 35 hours/week; consumer direct, 1 client, is medically necessary for this patient. 

The health plan's determination is upheld. 

The requested health service/treatment of 35 hours/week; consumer direct, 1 client is not medically necessary for this patient. The health plan's approved 21 hours per week of consumer direct care is sufficient to address her needs according to her Task-Based Assessment Tool and Uniform Assessment System - New York Comprehensive Pediatric  Assessment Report. The patient has had documentation of improvement in her skills in several areas, and no longer appears to be in need of 35 hours per week of consumer direct care. [1,2] 
Uniform Assessment System - New York Comprehensive Pediatric Assessment Reports were provided. On the Task-Based Assessment Tool, the patient was rated as requiring extensive assistance for bathing, personal hygiene, dressing her upper and lower body, toilet use, toilet transfer and eating, with supervision for eating. She required maximal assistance for meal preparation. It was calculated that she required 36.06 hours of consumer-directed service per week, and was provided 35 hours per week. On the Task-Based Assessment Tool, she was assessed as requiring extensive assistance with bathing, personal hygiene, toilet use and eating, limited assistance with dressing her upper and lower body, independent setup help only with toilet transfer, and supervision with walking and locomotion. It was calculated that she required 1.67 hours of consumer-directed support per day, or 11.69 hours per week. 

The Consumer-Directed Personal Assistance Program website describes that "Medicaid Consumer-Directed Personal Assistance Programs provide an alternative way of receiving home care services in which consumers have more control over who provides their care and how it is provided. Rather than assigning a home care agency that controls selection, training, and scheduling of aides, the "consumer," or the family member, friend, or guardian directing his or her care, performs all of these functions usually done by the agency."[3]
Appeal type: Medical necessity
Decision: Upheld

This is a patient who presented to the emergency department (ED) with a history of progressively worsening abdominal pain of 1 day duration. His evaluation included a physical exam, labs, and a computed tomography (CT) scan of the abdomen. He was without a fever at the time of presentation. Lab data identified an elevated white blood cell count (WBC) count of 8.7 thousand (K). A computed tomography (CT) scan yielded the diagnosis of acute appendicitis. Treatment was initiated with intravenous (IV) fluids and antibiotics. A surgical consultation was obtained on the day of presentation. The patient underwent a laparoscopic appendectomy. The clinical notes and the anesthetic record indicate an uncomplicated appendectomy. The operative note describes an acute, non-perforated appendicitis. He was provided IV fluids and perioperative antibiotics. His vital signs remained normal throughout the hospitalization without a recurrence of fever. He was discharged home. At issue is the medical necessity of an inpatient stay. 

The health plan's determination is upheld. 

This patient presented with abdominal pain. His evaluation with examination, lab data, and CT scan confirmed the diagnosis of appendicitis. The initial treatment appropriately included nothing by mouth (NPO) status, IV fluids, IV antibiotics and an appendectomy. The early post-surgical course was uncomplicated and the patient was clinically stable for discharge from the hospital on the first post-surgical day. The submitted clinical documentation does not support the need for inpatient admission. The patient required urgent surgical intervention for acute appendicitis; however, a lower level of care would have satisfactorily allowed for the care provided, including presurgical assessment, operative treatment and post-surgical monitoring, and would have been consistent with the accepted standard of medical care. 

The patient was clinically stable at the time of presentation and remained so during the course of care. He tolerated oral hydration, diet and medication and his pain was well controlled. There is no documentation of hemodynamic instability, sepsis or toxicity, significant electrolyte imbalance, bleeding, gastrointestinal (GI) obstruction or surgical complications.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Osteoarthritis- left hip; Left Total Hip Replacement 
 
Treatment: Inpatient Admission

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

This is a male patient with a history of anemia, high cholesterol, hypertension, and primary osteoarthritis of the left hip. The patient presented to the hospital for a left hip replacement. He underwent surgery for a total left hip replacement. He had a blood loss of 200cc during surgery. His white blood count (WBC) was elevated to 18,000. Postoperatively he received intravenous (IV) antibiotics. Occupational and physical therapy services were provided. He was deemed medically stable and discharged home.  

The medical record denotes a complex and extensive operation was performed. A large surgical incision was placed with performance of hip replacement. The patient lost at least 200cc of blood. He was reported to have an elevated WBC 18,000 and was receiving IV antibiotics. He still had a hemovac in place one day prior to discharge. He was also receiving PT services. It was unclear whether his condition had stabilized at that time. 

The level of service provided was applicable based upon diagnosis and treatment rendered. This type of operation is not commonly completed as outpatient or lower level of service. 

Observation would not be applicable as the procedure was not minor and expected to require less than 24 hours of service.

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

Based on the above, the medical necessity for the inpatient admission is substantiated.  The insurer's denial is reversed.
Appeal type: Experimental/Investigational
Decision: Overturned

Reviewer # 3:

This is a male patient who is status post ankle and lisfranc fracture dislocation that required irrigation, debridement, external fixation and skin grafting (grade 3B).  A VAC was placed due to tightness of wounds and tenuous nature of lateral skin graft.  His post-surgical course was complicated by blistering.  There also were small areas of eschar. 

The medical record demonstrated the young man was at extreme high risk for wound complications.  He had sustained an open fracture dislocation to his foot requiring multiple procedures.  He had issues with coverage and required a skin graft.  These facts substantiate a poor healing environment and problems with circulation (despite interpretation of normal blood flow to graft).  There had been distortion of normal anatomy and soft tissues.  The skin was thin and likely lack of subcutaneous tissues (several previous procedures cause distortion of anatomy and normal circulatory patterns).
 
The surgeon reported tenuous skin and tight closure.  Wound breakdown from tension would result in lack of coverage and extreme risk for infection and functional loss.  Utilization of an incision VAC device has been shown to be effective and decrease complication rate (high risk people).

A search was completed using PubMed (National Library of Congress).  The key words were VAC and foot surgery.  There were several references and meta-analysis which support use of the device for high risk patients. 

1) The scientific evidence in peer-reviewed literature supports a result of improvement in health outcome. 2) CPT 97606 (Negative Pressure Wound Therapy DME >50 sq cm) needs/has final approval from the appropriate regulatory bodies for this diagnosis. 3) This patient is a good candidate for CPT 97606 (Negative Pressure Wound Therapy DME >50 sq cm). 4) CPT 97606 (Negative Pressure Wound Therapy DME >50 sq cm) is the best available treatment for this patient at this time.

The use of the requested service (VAC) is likely to be more beneficial than any of the standard treatments for this patient. 

The carrier's denial of coverage for CPT 97606 (Negative Pressure Wound Therapy DME >50 sq cm) should be reversed.
Appeal type: Experimental/Investigational
Decision: Overturned

Reviewer #2: 

This is a male patient that underwent a right first and second tarsometatarsal repair of non-union and fusion, iliac crest bone graft harvest and intraoperative use of fluoroscopy.  After the second surgery a wound VAC dressing was placed, and an AO splint was applied.  After several months it was reported that he had started to weight-bear fully in a cam boot, and had been participating in physical therapy.  Physical examination findings included healed incisions, minimal swelling, alignment maintained and tenderness to palpation over the third metatarsal head.  

According to the documentation, the patient underwent a revision surgical procedure for arthrodesis of the first and second tarsometatarsal joints.  The procedure involves bone grafting and revision fixation.  The clinical documentation submitted for review indicates that the patient has had skin grafting and a tenuous closure in which an incisional VAC dressing was placed.  The literature indicates Negative Pressure Wound Therapy was the best available treatment for this patient.  He was a good candidate as this equipment is known to improve health outcomes regarding sealing the incision, preventing further infection, and wound complications.  

The wound VAC is likely to be more beneficial than any other standard treatment/ procedures.

Therefore, the request for CPT 97606 (Negative Pressure Wound Therapy DME >50 sq cm) is reversed.  

The carrier's denial of coverage for CPT 97606 (Negative Pressure Wound Therapy DME >50 sq cm) should be reversed.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: History of ankle fracture and Lisfranc fracture dislocation
 
Treatment: CPT 97606 (Negative Pressure Wound Therapy DME >50 sq cm)

The insurer denied the CPT 97606 (Negative Pressure Wound Therapy DME >50 sq cm). The denial was reversed.  
Reviewer #1:
This is a male patient with a history of a right first and second tarsometatarsal repair of non-union and fusion, iliac crest bone graft harvest and intra-operative use of fluoroscopy. A wound VAC dressing was placed as an incisional VAC given the tightness of the wounds and its tenuous nature, and given the lateral skin graft. An AO splint was then placed with the ankle in a neutral dorsiflexion. It was reported that several months after surgery he returned to the surgeon for a post-operative evaluation. Radiographic examination revealed interval healing mid-foot with hardware in place and intact. No sign of hardware failure. Negative Pressure wound therapy was requested.
The scientific evidence in peer-reviewed literature supports a result of improvement in health outcome. For difficult wounds such as the one presented in this case, Negative pressure therapy stabilizes the wound environment, reduces wound edema/bacterial load, improves tissue perfusion, and stimulates granulation tissue and angiogenesis. All this improves the possibility of primary closure of wounds and reduce the need for plastic procedures. The FDA granted 510(k) Class II clearance for the V.A.C. Via Negative Pressure Wound Therapy System, (KCI, San Antonio, TX) on March 10, 2010. It is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers 

This patient is a good candidate for CPT 976067 (Negative Pressure Wound Therapy DME > 50 sq cm). He is otherwise healthy and has a difficult and complex wound adjacent to a skin graft. CPT 97606 (Negative Pressure Wound Therapy DME > 50 sq cm) is the best available treatment for this patient at this time. For difficult wounds such as the one presented in this case, negative pressure therapy stabilizes the wound environment, reduces wound edema/bacterial load, improves tissue perfusion, and stimulates granulation tissue and angiogenesis. All this improves the possibility of primary closure of wounds and reduce the need for plastic procedures.

VAC therapy appears to be simpler and more effective than conventional dressings for the management of difficult wound in terms of reduction in wound volume, depth, treatment duration and cost. As an otherwise healthy patient with a difficult and complex wound adjacent to a skin graft, he is a good candidate for Negative pressure wound therapy. Therefore, Negative Pressure Wound Therapy DME >50 sq cm is likely to be more beneficial than any of the standard treatments/procedures for this patient.  

The carrier's denial of coverage for CPT 97606 (Negative Pressure Wound Therapy DME  >50 sq cm) should be reversed.
Appeal type: Medical necessity
Decision: Upheld

Parkinson's Disease
Nursing Services (including Private Duty Nursing)

The patient is a male with multiple past medical problems, most notably Parkinson's disease with ambulatory dysfunction. The patient requests an increase in services to a total of 84 hours a week of level 2 services, 12 hours a day 7 days a week. The patient requested additional services secondary to pain, limited mobility of Parkinson's disease and frequent falls. He also noted a decline in health care status. 

The health plan's determination is upheld. The Request for Increase in Personal Care Services, Level Two (2) to Total of 84 Hours per Week [12 Hours per Day / 7 Days per Week] is not medically necessary for this patient. The amount of services already being provided are sufficient to meet the patient's medical needs. Currently, the patient is noted to have medical necessity of 31.3 hours a week and he currently receives 56 hours a week of care.
The patient's evaluation, UAS State of New York showed a slight decrease in function in compared to the previous evaluation. 
There were no noted medical conditions which would require additional services. The patient's level of function showed a slight decrease between last year's evaluation this year's evaluation. The patient was able to manage with 56 hours a week of care previously. Additional services are not medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Primary Diagnosis:  Endocrine
Secondary Diagnosis:  PKU
Treatment:  Pharmacy/prescription drugs

The patient had  Phenylketonuria (PKU) diagnosed at birth and has been treated with a low protein diet and since 2014 with Kuvan.  Patient has had multiple Phe levels >10 mg/dl; however, the medical records indicate that the patient has not been compliant with her Kuvan treatment.  The AP requested an authorization for treatment with Palynziq in addition to Kuvan.

The health plan's determination of medical necessity is upheld in whole.  Palynziq is an injectable medication (enzyme substitute), that is Food and Drug Administration (FDA) approved for PKU patients 18 years of age or older with uncontrollable blood Phe levels above 600 micromol/l (10 mg/dl).  Documentation of elevated Phe levels while adhering to low protein diet and/or Kuvan for at least a month is an indication and requirement for initiation of Palynziq therapy.  Such documentation has not been provided by the patient's physician.  The medication is given on daily basis and can cause a severe allergic reaction (anaphylaxis) that may be life-threatening and can happen any time during treatment in 9% of the treated patients.  Palynziq is not to be used in combination with Kuvan, as requested by the attending physician.  Palynziq is only available through a restricted program called the Palynziq Risk Evaluation and Mitigation Strategy (REMS) Program.  Before a PKU patient can receive Palynziq, s/he must: 1) enroll in this program, 2) receive education about the risk of a severe allergic reaction (anaphylaxis) by a healthcare provider certified in the Palynziq REMS, 3) fill the prescription for the auto-injectable epinephrine and carry it at all times during treatment with Palynziq, 4) carry the Palynziq Patient Wallet Card at all times.
   
The therapy may be a viable option for patients with documented blood phenylalanine >600 mol/L who have failed existing management strategies.
At this point there is no evidence that this patient has uncontrollable blood Phe levels above 600 micromol/l (10 mg/dl) while adhering to  low-protein diet and Kuvan treatment.  Based on this the request for Palynziq cannot be justified as medically necessary.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Obesity
 
Treatment:  Ozempic 

The insurer denied coverage for Ozempic (semaglutide) 1 milligram (mg) per 0.75 milliliter (ml) pen injector quantity 2 every 30 days.  The denial is upheld. 

This patient is a female patient with obesity, polycystic ovary syndrome (PCOS), and sleep apnea.  She also has a history of glucose intolerance.  The patient is on Ozempic to help with weight loss.  She has tried Victoza and Belviq in the past with poor results.

Per Aroda VR. et al. (2019), "Guidelines recommend treatment goals targeting HbA1c, body weight, blood pressure, and low-density lipoprotein cholesterol.  Development of new treatments for type 2 diabetes requires an understanding of their mechanism and efficacy, as well as their relative effects compared to other treatment choices, plus demonstration of cardiovascular safety.  Subcutaneous semaglutide is a glucagon-like peptide-1 receptor agonist currently approved in several countries for once-weekly treatment of type 2 diabetes."  Per Fonseca, V.A. et al. (2019), "Across SUSTAIN 1-3, mean BW [body weight] was significantly reduced with semaglutide 0.5 mg (3.7-4.3 kg; p<0.0001) and semaglutide 1.0 mg (4.5-6.1 kg; p<0.0001) vs comparators (1.0-1.9 kg).  There were significantly greater reductions in IR with semaglutide 0.5 mg (27-36%) and semaglutide 1.0 mg (32-46%) vs comparators (17-28%).  Greater reductions in BW were generally associated with greater decreases in IR.  The effect on IR was primarily mediated by weight loss (70-80% and 34-94%, respectively, for semaglutide 0.5 mg and 1.0 mg vs comparator). . . .  Semaglutide consistently reduced BW and IR in subjects with T2D in SUSTAIN 1-3.  In this analysis, IR improvement was positively associated with, and primarily mediated by, the effect of semaglutide on BW."

Per Sorli C. et al. (2017), "Semaglutide significantly improved HbA1c and bodyweight in patients with type 2 diabetes compared with placebo, and showed a similar safety profile to currently available GLP-1 receptor agonists, representing a potential treatment option for such patients."                                                         

The health care plan acted reasonably and with sound medical judgment for the patient.      
Ozempic is not medically necessary for this patient.  There are other medications that are just as effective, if not more effective than Ozempic.  Ozempic is used for treatment of Type 2 diabetes.   The patient has glucose intolerance and not Type 2 diabetes. Furthermore, Ozempic is not Food and Drug Administration (FDA) approved for weight loss therapies.  Therefore, the request for Ozempic (semaglutide) 1 milligram (mg) per 0.75 milliliter (ml) pen injector quantity 2 every 30 days is not medically necessary for this patient.

Based on the above, the medical necessity for Ozempic (semaglutide) 1 milligram (mg) per 0.75 milliliter (ml) pen injector quantity 2 every 30 days is not substantiated.  The insurer's denial is upheld.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Urothelial cancer 

Treatment: Cxbladder Detect gene expression test

The insurer denied coverage for Cxbladder Detect gene expression test. The denial is upheld. 

This patient is a male with a history of urothelial cancer diagnosed several years ago. A Cxbladder Detect test was then ordered for surveillance of recurring urothelial carcinoma.  Clinical utility of the test was documented as adjunct to cystoscopy to rule out bladder cancer in patients with increased risk for the disease, adjunct to cystoscopy for the detection of bladder cancer (primary or recurrent) and to replace less sensitive noninvasive urine based tests. The test was collected; the test result was reported stating that the patient's Cx bladder monitor score was 3.0, which corresponded to a low probability of recurrent urothelial cancer.  
Cxbladder Detect is a noninvasive urine-based laboratory developed test (LDT) based on a bladder cancer molecular signature comprising the quantitative measurement of 5 m-RNA biomarkers clinically associated with urothelial cancer.  While the 2019 National Comprehensive Cancer Network guidelines for bladder cancer states that the evaluation of urothelial tumor markers (such as Cxbladder, FISH, NMP-22) may be considered during surveillance of high risk non-muscle invasive bladder cancer, the American Urological Association (AUA) guidelines at this point do not endorse the utilization of these biomarkers. As of to date, AUA only supports the use of Urovysion FISH test for further evaluation for patients with a history of atypical cytology but an unremarkable cystoscopy.  While biomarkers such as Cxbladder Detect have been shown to be more sensitive than urine cytology, they lack the specificity that urine cytology has in confirming the diagnosis of urothelial cancer. At the present time, most bladder tumor biomarker tests are considered adjunctive tests in the diagnostic exclusion of bladder cancer. And if utilized, literature indicates that these tests should only be conducted in conjunction with current standard diagnostic procedures (i.e. cystoscopy, urine cytology, CT urogram, ureteroscopy) for patients at concern for having urothelial cancer. Based on this literature review, the patient's Cxbladder Detect gene expression tests performed is not considered medically necessary for this patient.

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

The carrier's denial of coverage for the Cxbladder Detect gene expression test performed is upheld.  The medical necessity is not substantiated.