Persius/imr-appeals huggingface dataset:
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Gastroesophageal Reflux Disease

Treatment: Laparoscopic Esophageal Surgery and Hospital Admission

The insurer denied the laparoscopic esophageal surgery and hospital admission.

The denial was partially overturned.

This is a female patient with a past medical history of gastroesophageal reflux disease (GERD), hypertension, and scleroderma.  The injured worker had normal gastric emptying.  Clinical: the patient underwent testing which revealed a DeMeester score of 94.8 by pH study.  Per the Esophageal Motility Study, there was normal motility with borderline low esophageal sphincter pressure, reflux, and a hernia.  The patient's body mass index was 34.3.  The patient had previously been treated with increased doses of omeprazole, 40 mg twice a day, and an H2 blocker at night.  The patient continued to have upper GI symptoms including gastroesophageal reflux disease and intermittent dysphagia.

There is strong evidence that esophageal surgery is effective for severe gastroesophageal reflux disease refractory to medical management.  This patient has ongoing symptoms despite increasing dosage of proton pump inhibitor and an H2 blocker and therefore would benefit from esophageal surgical intervention.

As documented in the appeal letter (References #5 and #6), both the Society of American Gastrointestinal and Endoscopic Surgeons and the American Society of General Surgeons approve the use of the LINX device for severe gastrointestinal reflux disease. 

In the office visit the physician noted two possible laparoscopic surgical options, insertion of a LINX device or Nissen fundoplication, and concluded the device to be a better option for this patient.  However, the patient has a past medical history of scleroderma, and although esophageal manometry is normal, the safety and effectiveness of the LINX device has not been established in patients with scleroderma. 

Given the failure of medical management, laparoscopic esophageal surgery is the best option for this patient.  However, given the history of scleroderma, laparoscopic Nissen fundoplication is a better option for this patient than laparoscopic insertion of the LINX device. 

Esophageal surgery in the form of laparoscopic Nissen fundoplication is likely to be more beneficial for this patient than medical management.  Although, as noted by the surgeon, there is a risk of failure over her lifetime, given that the LINX device has not been demonstrated to be safe and effective in a patient with scleroderma, a laparoscopic Nissen fundoplication would be the recommended surgery. 

Laparoscopic LINX placement is not likely to be more beneficial than any standard treatments/procedures, and when indicated, can be done without a full hospital admission.

The carrier's denial of laparoscopic esophageal surgery and hospital admission should be upheld.
Appeal type: Medical necessity
Decision: Overturned

The patient  presented with symptomatic left lower extremity varicose veins. The symptoms include pain, cramps and swelling of the left leg. Patient has attempted and failed conservative therapy with graded compression stockings without symptomatic relief. The patient underwent endovenous ablation of left great and small saphenous vein as well as stab phlebectomies of left lower extremity. The health plan's determination is overturned in part.
The endovenous ablation of the left great saphenous vein is Medically Necessary based on the peer reviewed literature. The left leg stab phlebectomies are Medically Necessary based on the peer reviewed literature, however, the endovenous ablation of the left small (lesser) saphenous vein, is not Medically Necessary because there is no evidence of reflux in this vein on the preoperative lower extremity venous duplex scan. The current treatment strategy for many patients with varicose veins is endovenous thermal ablation. The most common forms of this are endovenous laser ablation (EVLA) and radiofrequency ablation (RFA).
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Left Upper Extremity Deep Vein Thrombosis 

Treatment: Inpatient Admission

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

This is a middle aged female patient who presented to the Emergency Room in late 2018 for a chief complaint of chest and arm pain for the week prior to presentation.  The patient reported that she had mild swelling in the right underarm and heart palpitations.  The patient had a past medical history significant for an immune disorder, end-stage renal disease following a transplant, hypertension, hyperlipidemia, hyperparathyroidism, asthma, bilateral deep vein thrombosis and arterial thrombosis.  Upon assessment the patient had a blood pressure of 191/114 and she was alert and in no apparent distress.  An electrocardiogram (EKG) revealed a heart rate of 70 beats per minute (bpm) with no acute infarction.  Her creatinine was 2.17, hemoglobin was 16.5 and troponin level was negative.  An upper extremity Doppler revealed a deep vein thrombosis in the left subclavian and axillary vein.  A heparin drip was initiated.  

The MCG general admission guidelines state that an inpatient admission is recommended when intravenous (IV) anticoagulation, vasoactive medication or antiarrhythmic medication is to be administered.  

MCG heparin guidelines state that inpatient admission is recommended for a patient who requires post hospital oral anticoagulation therapy and who is not anticoagulated and is of high risk of short-term venous or arterial thromboembolism that is newly diagnosed.  

There was documentation that the patient had a history of bilateral lower extremity deep vein thrombosis (DVT) and was diagnosed with a left upper extremity deep vein thrombosis in the Emergency Department.  The patient was not taking an oral anticoagulant at the time of assessment, was started on intravenous (IV) heparin and subsequently admitted to the hospital as an inpatient.  There was documentation that the patient continued IV Heparin and then started on an oral dose of Eliquis thereafter.  

The carrier's denial of coverage for the inpatient hospital services at the inpatient level of care from is modified.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Breast Cancer. 
Treatment: Trastuzumab and Pertuzumab in combination with Docetaxel and Carboplatin. 

The insurer denied Trastuzumab and Pertuzumab in combination with Docetaxel and Carboplatin. 
The health plan's determination is overturned in part. 

This is a female with left breast cancer. Neoadjuvant therapy with trastuzumab + pertuzumab + docetaxel + carboplatin is under review.

The use of trastuzumab +docetaxel + carboplatin is medically necessary. 
The provider makes a point of stating that she was treating this patient based on data from the TRYPHAENA trial. To be eligible for this trial patients had to have a T2 or larger primary breast cancer with or without lymph node involvement. Based on the results of this trial, the Food and Drug Administration (FDA) granted accelerated approval for the addition of pertuzumab to neoadjuvant chemotherapy (NACT) and trastuzumab for patients with HER2-positive locally advanced, inflammatory, or early-stage (either greater than 2 centimeters (cm) in diameter or node-positive) breast cancer. This patient did not meet these criteria. Support for the use of pertuzumab is not present in national guidelines nor the peer-reviewed literature. For these reasons, the medical necessity for pertuzumab cannot be established. 
It should be noted, however, that non-anthracycline-containing neoadjuvant breast cancer regimens with trastuzumab are indicated for patients with 0.6 cm or larger lesions. Numerous trials have demonstrated a benefit in this setting and for these reasons, the National Comprehensive Cancer Network (NCCN), the authors of Up-To-Date, and the peer-reviewed literature support the use of trastuzumab + docetaxel + carboplatin.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Neuralgia with facial pain
Treatment: Inpatient admission
The insurer denied the inpatient admission.
The denial is overturned, in part. 

Yes, in part; the inpatient admission was medically necessary.

The patient is a male with history of trigeminal neuralgia with facial pain who presented to the ED with severe attacks. The patient was admitted for pain control and given Dilantin with the plan for surgical treatment. Magnetic resonance image (MRI) was performed and the patient was planned for surgery. The patient underwent craniotomy for microvascular decompression. 

With regards to the inpatient stay, the acute inpatient level of care is deemed medically necessary as the patient underwent craniotomy and surgical decompression of the trigeminal nerve.  Acute inpatient level of care is deemed medically necessary and appropriate postoperatively as the patient required pain control and close neuro-checks to ensure that there were no complications postoperatively. 

However, there is insufficient evidence that the patient required acute inpatient level of care prior as the patient did not have any acute inpatient needs on these dates. The initial surgery was planned but was cancelled and the subsequent days until it was performed were not medically necessary for acute inpatient level of care.  

Therefore, the inpatient stay is partially approved.
Appeal type: Medical necessity
Decision: Overturned

This is apatient who has a long history of lower back pain. He developed this lower back pain after a motor vehicle accident in 2006. He describes his pain as constant, sharp, and localized in the lower back. His past medical history includes sleep apnea. There is no documented prior history of any low back surgeries. Physical examination was unremarkable except tenderness to palpation in the paraspinal region with positive facet loading test. 

The health plan's determination is overturned in part. This patient has a long history of low back pain since 2006, and failed extensive treatments including PT, and pain medications. It is medically necessary for two level RFA. The 3rd level RFA is not medically necessary based on available medical records.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: GERD
Treatment: Laparoscopic Esophageal Surgery and Hospital Admission (43284) (Pre-Service)
The insurer denied the Laparoscopic Esophageal Surgery and Hospital Admission (43284) (Pre-Service). 
The denial is overturned. 

The patient is a female with Gastroesophageal Reflux Disease. Symptoms of bile in her mouth after meals if she lies down or bends over.  Endoscopy revealed no Barrett's esophagus or Malignancy.  pH testing of the esophagus revealed a DeMeester score of 41, which is about 2.5x the upper limit of normal.  Manometry revealed 60% normal swallows. Upper GI barium x-ray revealed mild esophageal dysmotility.  

Yes, the health plan should cover the proposed LINX procedure and the related hospital admission.

Yes, the requested health service or procedure is likely to be more beneficial than any standard treatment or treatments for the insured's condition or disease.

This patient suffers from GERD causing regurgitation.  Even with medications, there is refluxing gastric contents.  Surgical therapies exist that resolve this very well. Without LINX procedure, a Laparoscopic Nissen Fundoplication (LNF) would have been recommended.  Other techniques have been tried endoscopically and otherwise, but none have been able to demonstrate long term efficacy and safety.  The side effects of LNF make it a less than ideal operation.  Linx is an operation that is less disruptive to the normal anatomy, has been shown to be effective at reducing reflux episodes to a physiologic level, and has been shown to dramatically improve patient satisfaction long term.  It is approved by the FDA.  There is published data on patients who have had the device for six years, showing a very low complication rate and a high resolution of GERD.

I do not believe any evidence has been published in support of this operation being performed at a level of care lower than inpatient, and the standard of care is to perform the operation as an inpatient.  Therefore, it is recommended to approve this operation as an inpatient.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Hypertension, hyperlipidemia, diabetes, peripheral arterial disease (PAD), hypothyroidism, anemia, glaucoma, and spinal stenosis

Treatment: Personal care assistance (PCA) two 12 hour split shifts per day, 7 days a week

The insurer denied coverage for PCA two 12 hour split shifts per day, 7 days a week

The denial is modified

 
This is an elderly patient with diabetes, PAD and Alzheimer's dementia. She lives with her sister and daughter in a private residence. The insurer approved PCA 8 hours/day, 7 days/week. The request is for PCA 2-12 hour shifts, 7 days/week.

The recent Uniform Assessment System (UAS) was reviewed. The patient's cognition is described as severely impaired. She is totally dependent for much of her Instrumental Activities of Daily Living (IADL) tasks including ordinary housework, meal preparation and shopping. She requires maximal assistance for bathing, lower body dressing and toilet use. She is frequently incontinent of bladder and continent of bowel. Extensive assistance is needed for personal hygiene, upper body dressing, toilet transfer, locomotion and ambulation. She reportedly wanders (unescorted) in the hallway of the building. She is independent with eating and bed mobility.  Her cognitive status and functional ability have declined compared to the prior UAS report. 

The patient is waking up at night, getting out of bed and potential falls risk as well as wandering are of particular concern. However, her need for level 1 or 2 services during nighttime hours are not at a level or unpredictable as to require the requested PCA services, 2-12 hour shifts per day, 7 days a week. This physician would agree due to safety concerns the patient may require additional monitoring for her own safety; particularly at night. Unfortunately, safety monitoring under PCA services does not include monitoring an individual (e.g. with dementia) when no other Level 1 or Level 2 personal care services task is being provided. Based on the documents reviewed the currently approved PCA services 8 hours/day, 7 days/week are inadequate to meet the patient' functional needs. Based on the documents reviewed, increasing PCA services to 12 hours/day, 7 days/week is more appropriate to meet the patient's functional needs. 

Based on the above, the insurer's denial must be modified. The health care plan acted reasonably in part. 

The medical necessity for personal care assistance services (PCA) two 12-hour split shifts per day, 7 days a week services is not substantiated. However, increasing PCA services to 12 hours/day, 7 days/week is medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Achalasia and gastroparesis
Treatment: Botox injections
The insurer denied the botox injections.  
The denial is overturned, in part.

The Botulinum toxin is medically necessary, in part.


Specifically, the provision of Botox for achalasia is an accepted and appropriate and medically necessary procedure. However, the provision of Botox for gastroparesis is not supported and therefore not a medically necessary procedure.

The patient is a female. The patient has a history of achalasia and gastroparesis.

As treatment for those conditions, the patient's provider undertook the provision of Botox for the lower esophageal sphincter and the pyloric sphincter. The plan denied these treatments, which are the subject of this review.

The patient has gastroparesis. The patient is symptomatic. As treatment for this condition, the provider requested provision of Botox as treatment as delivered during endoscopy.

At this time, there is inadequate support in the medical literature to conclude that the provision of Botox for gastroparesis has a positive effect on healthcare outcomes. There are small studies with limited conclusions, and there are no double-blinded studies of sufficient patient enrollment to draw definitive conclusions.

The AGA concludes as follows:

"Intrapyloric injection of botulinum toxin is not recommended for patients with gastroparesis based on randomized controlled trials. (Strong recommendation, high level of evidence)"

Pasricha and Pasricha note as follows:

"Refractory gastroparesis is among the most difficult therapeutic challenges in gastroenterology. Pyloric dysfunction has been described in a subset of patients with gastroparesis, prompting experimentation with botulinum toxin injections into the pylorus, which is relatively safe and has been successfully used in other gastrointestinal disorders. However, causality between pyloric dysfunction and symptoms of gastroparesis has never been demonstrated. Although several open-label studies showed initial promise, 2 randomized clinical trials failed to elicit a difference in clinical outcomes in botulinum toxin versus placebo. Based on current evidence, further use of botulinum toxin for gastroparesis is discouraged outside of a research trial."

There is no medical support to provide Botox as treatment for gastroparesis at this time.

Kumar et. al. note "Endoscopic intrasphincteric injection of Botox (ISIB) is used routinely for the treatment of achalasia esophagus and other spastic motor disorders. Studies show that the ISIB reduces the smooth muscle lower esophageal sphincter (LES) pressure."

Therefore, the Botox as treatment for achalasia is medically necessary, given the wealth of literature in support for this.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Gynecological. 
Treatment: Infertility Treatment. 
The plan denied hormone treatment and IVF cycle. 
The determination is overturned in part.

The patient is a female who had undergone previous in vitro fertilization (IVF) cycles for infertility which had been unsuccessful. At the recommendation of her treating provider she underwent in-vitro fertilization (IVF) cycle, the result of which was 3 fertilized eggs being transferred. This cycle was successful, and the patient is pregnant.
The subject under review is the medical necessity for the high dose gonadotropins (greater than [>] 450 international units [IU] daily) and the IVF cycle.

The subject under review is the gonadotropins and IVF cycle.

The health plan's determination is overturned in part. 

The gonadotropin dose beyond 450 IU daily was not medically necessary. Published evidence does not support gonadotropin dosages beyond 450 IU daily. However, the IVF cycle was medically necessary.
This patient had infertility.  Based on the American Society of Reproductive Medicine (ASRM) definition that includes "numerous assisted reproductive technologies (ART) cycles without adequate...embryo development," the IVF cycle was medically necessary for this patient.
In a Cochrane review, that included 27 randomized controlled trials (RCTs) (4031 couples or women) it reported failure to transfer any embryos was higher in the blastocyst transfer group (OR 2.50, 95% confidence interval [CI] 1.76 to 3.55; 17 RCTs, 2577 women, I(2) = 36%, moderate quality evidence). This suggests that if 1% of women have no embryos transferred in (planned) fresh cleavage stage transfer, between 2% and 4% will have no embryos transferred in (planned) fresh blastocyst stage transfer.
This data in combination with American Society of Reproductive Medicine (ASRM) guidelines regarding poor prognosis cycles which states that when changing a major aspect of the protocol (such as the day of transfer), the prognosis can change despite a history of failed cycles. Thus, as this cycle was doing something decidedly different, doing the embryo transfer at the multicell stage as opposed to the blastocyst stage, a subsequent cycle was reasonable and medically necessary.
Appeal type: Medical necessity
Decision: Overturned

The patient has a diagnosis of Major Depressive Disorder (MDD). The patient's mental status examination on admission noted depressed mood, suicidal ideation, insomnia, low energy, anxiety, and low motivation. The patient expressed the belief that if not admitted to the current IHS patient believed that they  would commit suicidal. Prior to this current hospitalization, patient showed functional impairment in several areas: not paying her bills; lost volunteer job; was homeless after having been evicted. Patient has required at least 4 prior IHS admissions. Patient was sexually abused as a teenager. Patient received pharmacological treatment. Additionally, the patient received individual and group therapy, social work services, and discharge planning.

The health plan's determination is overturned in part. The two additional days past the original days approved by the health plan are necessary to document that the patient had improved sufficiently from the patient's chronic suicidality. A team progress note noted no suicidal ideation, as well as documenting that the patient was future oriented, compliant with her medications, and was attending meetings.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Hepatitis.
Treatment: Mavyret Tab 100-40mg .
The insurer denied Mavyret Tab 100-40mg (12 weeks). 
The health plan's determination is overturned in part. 

The patient is a female with chronic Hepatitis C, genotype 3. She has failed PEG-interferon with ribavirin for 24 weeks. Viral load was 2,600,000. FibroScan showed liver stiffness of 7.0. She is reported to be non-cirrhotic. Under review is the use of Mavyret 100-40 milligrams (mg) for 12 weeks for the treatment of chronic Hepatitis C, genotype 3.

Mavyret 100-40 mg is medically necessary for 8 weeks in non-cirrhotic genotype 3 patients with chronic Hepatitis C. The current medical literature does not support 12 weeks of Mavyret therapy based on the provided documentation. According to joint guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), all patients with chronic Hepatitis C, regardless of fibrosis, should be treated except those with limited life expectancy due to non-liver-related comorbid conditions (Class I, Level A recommendation). According to the guideline, the guideline "no longer contains retreatment recommendations for interferon or interferon plus first generation protease inhibitor failures because the cure rates with modern direct-acting antiviral regimens in these populations were comparable to treatment naive patients" . In cirrhotic or non-cirrhotic genotype 3 patients who have failed an interferon regimen such as this patient, Mavyret for 8 weeks is recommended as first-line therapy. This is based on a 95% cure rate in the ENDURANCE-3 trial, as well as multiple subsequent studies.