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

Diagnosis: Prostate cancer
Treatment: Hydrogel perirectal spacers
The insurer denied the Hydrogel perirectal spacers. 
The denial is overturned. 

The patient is a male with favorable intermediate prostate cancer Gleason 3+4 and PSA (prostate specific antigen) less than 10 referred for definitive radiotherapy.  

Yes, the Hydrogel perirectal spacers is likely to be more beneficial.

Radiotherapy includes several approaches using high-energy rays to destroy cancer cells. Radiotherapy used in prostate cancer can be classified based on the location of the ray sources, types of rays, and position relative to the prostate   When external beam radiation is targeted at the prostate, other adjacent organs are also exposed to radiation.  The rectum is located in front of the prostate; because of its vulnerability and the potential for gastrointestinal adverse effects, the rectum is the dose-limiting organ at risk.   For localized prostate cancer, sparing the anterior rectal wall has been emphasized as an important priority to safely deliver effective doses of radiation.

Spacers can be used to increase the distance between the prostate and the rectum in order to protect the rectum from exposure to radiation.  There are several types of spacers, including balloons, plastic rods, and polyethylene-glycol (PEG) hydrogel.  PEG hydrogel works like a mesh that contains PEG oligomers and polymers to retain large quantities of water, forming a stable and flexible structure with texture similar to gel.  The hydrogel spacers are injected to the space between Denonvilliers fascia and the anterior rectal wall under transrectal ultrasonography (TRUS) guidance.  The procedure for injections of the PEG hydrogel takes about 16 minutes from TRUS insertion to TRUS removal.  

Once placed in the human body, the PEG hydrogel spacer can maintain integrity for three months and is eventually degraded, with the residual excreted in the urine.  

The use of hydrogel spacers has demonstrated clinical effectiveness in the prevention of rectal toxicity to treat patients with localized prostate cancer undergoing radiotherapy, based on multiple peer-reviewed medical literatures.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Prostate cancer
Treatment: Hydrogel perirectal spacers
The insurer denied the Hydrogel perirectal spacers. 
The denial is overturned. 

Yes, the health plan should cover the Hydrogel perirectal spacers.

The patient is a male diagnosed with stage II, T1c, N0, M0 prostate cancer on active surveillance. He has developed rising PSA (prostate specific antigen), and biopsy showed Gleason 3+4=7 adenocarcinoma and PSA 8.38.

A prospective multicenter randomized controlled pivotal trial (NCT01538628) was performed to assess outcomes following absorbable spacer (SpaceOAR system) implantation (Ref #4). This trial enrolled 222 patients, with primary end points being the following:

1) Proportion of subjects achieving a reduction of 25% or greater in percent volume of the rectum receiving at least 70 Gy measured from CT scans acquired pre and post SpaceOAR hydrogel injection [Time Frame: three months post index procedure], and 

2) Proportion of subjects experiencing a Grade 1 or greater rectal adverse event or procedure adverse event in the six months following treatment. Patients were treated with IMRT to 79.2 Gy in 1.8Gy per fraction X 44 fractions with daily IGRT. 

With the median follow-up of three years, the three-year incidence of grade =1 (9.2% vs 2.0%; P=.028) and grade =2 (5.7% vs 0%; P=.012) rectal toxicity favored the spacer arm. Grade =1 urinary incontinence was also lower in the spacer arm (15% vs 4%; P=.046), with no difference in grade =2 urinary toxicity (7% vs 7%; P=0.7). From six months onward, bowel QOL (quality of life) consistently favored the spacer group (P=.002), with the difference at three years (5.8 points; P<.05). 

This trial demonstrated that prostate-rectum hydrogel spacer application is a relatively safe technical procedure which is well tolerated and has a high technical success rate. Spacer application significantly reduces rectal radiation dose, and results in long-term reductions in rectal toxicity as well as improvements in bowel, urinary and sexual QOL. FDA approved hydrogel indicated to create distance between the prostate and rectum based on the results from phase 3 clinical trial. 

Based on the published evidence and FDA approval, SpaceOAR implantation into peri-rectal space prior to IMRT (intensity modulated radiation therapy) is a commonly performed standard procedure for prostate cancer.

Hypofractionated IMRT (intensity modulated radiation therapy) of 5/5 weeks with Transperineal placement of SpaceOAR into peri-prostatic tissue is planned.

The Hydrogel perirectal spacers are likely to be more beneficial.

The use of perirectal spacers during IMRT for prostate cancer has been demonstrated to decrease rectal toxicities on prospective multi-center randomized phase III trial.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Prostate cancer
Treatment: Hydrogel perirectal spacers
The insurer denied the Hydrogel perirectal spacers. 
The denial is overturned.

Yes, the Hydrogel perirectal spacers are likely to be more beneficial.

The patient is a male with prostate cancer.  Definitive radiation therapy with SBRT (Stereotactic Body Radiation Therapy) was recommended, and transperineal placement of biodegradable material prior to radiation treatment was requested.

Biodegradable and absorbable hydrogel spacer is used to reduce unintentional rectal injury in men undergoing prostate radiotherapy (RT). With ultrasound guidance, the hydrogel is injected as a liquid that expands the space between Denonvilliers' fascia and the rectal wall, where it solidifies into a hydrogel within 10 seconds. The hydrogel remains in place for three months during prostate radiotherapy, after which it is liquefied and is absorbed and cleared in the patient's urine.  Administration of the hydrogel spacer is an FDA-approved procedure for patients undergoing radiation for prostate cancer.  
There is data showing dosimetric and clinical advantages of biodegradable hydrogel placement for patients undergoing prostate radiation.  A multi-institution phase III trial evaluated hydrogel intending to create a rectal-prostate space for patients with prostate cancer undergoing image guided intensity modulated radiation therapy.  A total of 222 men were randomized 2:1 to the spacer or control group and received 79.2 Gy in 1.8-Gy fractions to the prostate with or without the seminal vesicles.  The three-year incidence of grade >=1 (P=.028) and grade >=2 (p=.012) rectal toxicity favored the spacer arm. Grade >=1 urinary incontinence was also lower in the spacer arm.  

From six months onward, bowel QOL (quality of life) consistently favored the spacer group (P=.002), with the difference at 3 years (5.8 points; P<.05) meeting the threshold.  The authors concluded that "The benefit of a hydrogel spacer in reducing the rectal dose, toxicity, and QOL declines after image guided intensity modulated radiation therapy for prostate cancer was maintained or increased with a longer follow-up period, providing stronger evidence for the benefit of hydrogel spacer use in prostate radiation therapy." 

Definitive radiation therapy with SBRT was recommended, and transperineal placement of biodegradable material prior to radiation treatment was requested.  According to numerous studies including a randomized trial, hydrogel spacer placement has been shown to reduce rectal toxicity for prostate patients treated with high dose radiation.  It is therefore likely to be more beneficial than any standard treatment or treatments for this patient's prostate cancer.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: central nervous system /neuromuscular disorder /other 
Treatment: Pharmacy/prescription drugs . 
The insurer denied  Gammagard (IVIG).
The denial is upheld in whole.  

The patient  who was diagnosed with autoimmune encephalitis by her neurologist. A neurology note describes that the  symptoms comprised obsessive compulsive disorder, attention deficits, choreoathetoid and tic-like movements.
The requested health service/treatment of Gammagard is not medically necessary for this patient.
According to the documentation submitted for review, the patient does not appear to have had neuroimaging in the form of a recent magnetic resonance imaging (MRI) of the brain, nor a spinal tap with studies of the cerebrospinal fluid, including autoantibodies. The diagnosis of autoimmune encephalitis appears to have been made on the basis of an abnormal Cunningham panel. Several authors have cast doubt on the reliability, sensitivity and specificity of this laboratory test, which is performed in patients with suspected Pediatric Acute-onset Neuropsychiatric syndrome (PANS) or Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infection (PANDAS). Hesselmark and Bejerot {1] reported that "Sensitivities of individual biomarkers in the Cunningham Panel ranged from 15 to 60%, and specificities from 28 to 92%. Positive predictive values ranged from 17 to 40%, and negative predictive values from 44 to 74%. A majority of the healthy controls had pathological Cunningham Panel results and test-retest reliability proved insufficient." The authors concluded that "Clinical use of the Cunningham Panel in diagnosing PANS or PANDAS is not supported by this study."
Gilbert et al [12] describe that "there remains a pressing need to define better the clinical manifestations, laboratory and neuroimaging findings, therapeutic responses, and clinical course in these disorders." The authors conclude "We are especially concerned about unsubstantiated reports from clinical researchers who have concluded, despite the lack of rigorous human studies, that there is a prominent role for inflammation in cases with fulminant, severe, disabling psychiatric-only presentations. This assumption often leads to overuse of antibiotics and unwarranted exposure of children to powerful immunomodulatory agents."
Intravenous immunoglobulin (IVIG) has potential risks associated with its use. Katz et al [13] describe "Most adverse effects are mild and transient including headaches, flushing, fever, chills, fatigue, nausea, diarrhea, blood pressure changes and tachycardia. IgA deficiency-related anaphylactic reactions are largely preventable. Late adverse events are rare and include acute renal failure and thromboembolic events."
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Acne
Treatment: Clindamycin-Tretinoin gel 
The insurer denied the Formulary exception for Clindamycin-Tretinoin gel. 
The denial is upheld. 

The patient is a woman with acne for whom Ziana (Clindamycin-Tretinoin) gel is requested. She has been using it and is stable on it.

Clindamycin-Tretinoin gel is not on the formulary, and acceptable alternatives are available. The alternatives include Cleocin-T, clindamycin lotion/solution/swab and tretinoin cream/gel. There is no documentation that the patient has tried and failed or has an intolerance or contraindication to the use of the available alternatives. Therefore, the health plan should not cover the Formulary exception for Clindamycin-Tretinoin gel.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis:Foot disorder/Other  
Treatment:Surgical Services.  
The insurer denied joint manipulation on the right foot in the outpatient setting.  
The denial is upheld 

The patient is a female who previously underwent right first metatarsophalangeal joint implant arthroplasty. The patient  has had pain since  surgery. The patient attempted a course of physical therapy which did not improve symptoms. The provider has since made a request for manipulation under anesthesia of the first metatarsophalangeal joint to mobilize the joint and disrupt adhesions.

No, there is no evidence in the current peer-reviewed medical literature that demonstrates that the requested treatment is likely to be more beneficial than any standard treatment for the patient's condition.

There are currently no widely accepted guidelines on standards for the practice of manual therapy manipulation under anesthesia, and the evidence base for this practice is composed primarily of lower-level evidence (1). Manipulation of the metatarsophalangeal joint and injection with steroid and local anaesthetic are widely practiced in the treatment of hallux rigidus, but there is little information on the outcome (2). In a study by Solan et al (2), it was recommended that joints are graded before treatment and that manipulation under anaesthetic and injection be used only in early (grades I and II) hallux rigidus. If this patient has already undergone first metatarsophalangeal joint implant arthroplasty, then she must have had a late-stage hallux rigidus. There is a paucity of published data that exists on the use of this modality in the foot and ankle (3). Therefore, the requested treatment is not likely to be more beneficial than any standard treatment.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis:Foot disorder /Other  
Treatment:Surgical Services.  
The insurer denied joint manipulation on the right foot in the outpatient setting.  
The denial is upheld 

This is a female patient who presented regarding stiffness and pain after implant arthroplasty of the great toe joint. The request is for manipulation under anesthesia in an outpatient surgery center or hospital setting. 

No, the proposed joint manipulation of the right foot in the outpatient setting was not likely to be more beneficial than standard treatment. There is insufficient documentation that this procedure would result in a more beneficial outcome to the patient. If joint manipulation is planned it could be administered in the office by a regional nerve block which is a simple standard procedure.

There are many types of great toe implants; the type used in this case is not mentioned in the records submitted for review. The physical therapy record indicated improvement. The provided documentation is of one post-operative note in which there is insufficient information to make a decision.

In this case there were no x-rays available as well as no preoperative or postoperative chronological records provided. The supporting documentation submitted for review is for knees, with 1 article that discusses the great toe joint, but not after surgery.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Foot disorder/Other  
Treatment: Surgical Services.  
The insurer denied joint manipulation on the right foot in the outpatient setting.  
The denial is overturned

The patient is a female with a history of a hallux rigidus of the right first metatarsophalangeal (MTP). The patient underwent an implant arthroplasty surgical procedure of the right great toe joint because of the painful osteoarthritis. During the postoperative period, the records state the patient was experiencing pain and stiffness in the right great toe joint.
Yes, the proposed joint manipulation on the right foot is likely to be more beneficial.
In the case reviewed the patient underwent an implant arthroplasty of the big toe joint for the treatment of a Hallux Rigidus which is caused by osteoarthritis. The surgery is performed in the big toe joint. During the postoperative period mobility of the big toe joint is very important to prevent adhesions and scarring. Unfortunately, the patient in this case developed joint stiffness and pain. The clinician states the cause was by adhesions and scar tissue fibrosis.
Stiffness, flexion contractions, and adhesions of the first metatarsal phalangeal joint is a common complication or development after a joint decompression, implant surgery or cheilectomy surgery. Often patients will need physical therapy to reduce scar tissue and adhesions in the joint. Occasionally, patients may develop arthrofibrosis and this is unlikely to respond to conservative treatments. These patients may need to return to the operating room for manipulation of the first MPJ under anesthesia, manipulation under anesthesia (MUA) to break up the adhesions, increase range of motion and reduce pain.
The MUA procedure is not new. In fact, 1927 Cochrane and Watson Jones first proposed the manipulation under anesthesia at the MTPJ as a means of breaking down capsular adhesions which were responsible for the flexion contracture. They reported the MUA and injection with steroids to be a safe procedure and provided good symptomatic results. This procedure has a low risk or harm to the patient and can prevent revisional surgery.
In the above case the clinician had performed standard of care treatments. The decision of joint manipulation (MUA) in the outpatient setting is necessary and beneficial. It is likely the procedure is more beneficial than any other standard of care treatments at this time.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Mental Health 
Treatment: Pharmacy/Prescription Drugs. 
The insurer denied Vraylar. 
The denial is upheld in whole.

The patient is a female diagnosed with bipolar disorder; most recent episode depressed. The patient has been prescribed Vraylar (cariprazine) 1.5 mg daily with plan to titrate as clinically appropriate with the usual dosage range of 1.5 to 3 mg per day for the depressive phase and 3 to 6 mg per day for the manic or mixed phase. Vraylar is a non-formulary drug. Suggested formulary alternatives include the following medications: aripiprazole, Latuda, olanzapine, paliperidone extended release (XR), quetiapine, risperidone, Saphris, and ziprasidone.
The patient had previously failed to benefit from several selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), Wellbutrin, Remeron, mood stabilizers including lamotrigine, stimulant medication including Focalin, and Rexulti. The patient has had a course of electroconvulsive therapy that was helpful and has also used anxiolytic medications to address co-morbid generalized anxiety and posttraumatic stress disorder with trauma related symptoms. She has ongoing psychotherapy with a skilled and certified psychotherapist. Current medications include Wellbutrin, Klonopin, clonidine for sleep, and Vraylar at a starting dose of 1.5 mg daily. It is not clearly documented whether the patient has not taken other available formulary agents in the same class including aripiprazole, Latuda, olanzapine, paliperidone XR, quetiapine, risperidone, Saphris, and ziprasidone.
The subject under review is the use of the non-formulary drug Vraylar.

The health plan's determination is upheld in whole.

In considering whether the formulary drug (aripiprazole, Latuda, olanzapine, paliperidone extended release, quetiapine, risperidone, Saphris, ziprasidone) will be or has been ineffective, or would not be as effective as the non-formulary drug (Vraylar), or would have adverse effects; there is no information that would suggest that the formulary drug (aripiprazole, Latuda, olanzapine, paliperidone extended release, quetiapine, risperidone, Saphris, ziprasidone) will be or has been ineffective, would not be as effective as the non-formulary drug (Vraylar), or would have adverse effects.
The submitted information does not indicate which of the second generation antipsychotic/atypical antipsychotic medications have been tried and failed. Several of the he formulary drugs (aripiprazole, Latuda, olanzapine, paliperidone extended release, quetiapine, risperidone, Saphris, ziprasidone) are likely to be as effective as the non-formulary drug (Vraylar) or would be no more likely to have adverse effects.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Cerebrovascular Accident, Right Hip Fracture, Dementia

Treatment: Personal Care Aide (PCA) Level 2: Live-In Per Diem - 24 hours per day - 7 days per week

The insurer denied coverage for PCA Level 2: Live-In Per Diem - 24 hours per day - 7 days per week. 

The denial is overturned.

This is a male patient who has been receiving PCA services 6 hours/day 7 days per week. There is a history of diabetes mellitus (DM), peripheral artery disease (PAD) and cerebrovascular accident (CVA) with subsequent right hip fracture. The patient's daughter has noted that he has gait problems and falls. He recently developed dementia. She requested an increase in PCA services to 24 hours/day 7 days a week.

The patient's level of function has deteriorated since the CVA and right hip fracture. He has had pressure sores and needs increased help with activities of daily living (ADLs), which cannot be provided by family. The level of PCA services he needs cannot be provided by the patient or informal sources. This includes the need for night-time services that are unpredictable and include toileting, ambulation and transfers. The patient needs some-total assistance across a broad range of ADLs. He requires a walker and 2-person assist. He has started to have cognitive dysfunction at night due to dementia. He cannot be left alone safely. 

New York Codes Rules and Regulations, Title: Section 505.14 Personal Care Services state in part: Personal care services means assistance with nutritional and environmental support functions and personal care functions. Such services must be essential to the maintenance of the patient's health and safety in his or her own home, as determined by the social services district in accordance with this section; ordered by the attending physician; based on an assessment of the patient's needs and of the appropriateness and cost-effectiveness of services; provided by a qualified person in accordance with a plan of care; and supervised by a registered professional nurse. Continuous personal care services means the provision of uninterrupted care, by more than one personal care aide, for more than 16 hours in a calendar day for a patient who, because of the patient's medical condition, needs assistance during such calendar day with toileting, walking, transferring, turning and positioning, or feeding and needs assistance with such frequency that a live-in 24-hour personal care aide would be unlikely to obtain, on a regular basis, five hours daily of uninterrupted sleep during the aide's eight hour period of sleep.

The plan did not give adequate consideration to changes in the patient's condition. They did not act reasonably in the best interest of the patient. The patient has increased needs during times when he is currently alone. 

The carrier's denial of coverage for Personal Care Aide (PCA) Level 2: Live-In Per Diem - 24 hours per day - 7 day(s) per week, is overturned. The medical necessity is substantiated.