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

Diagnosis: Digestive System/Gastrointestinal/Crohn's Disease.
Treatment: Lab Work/Blood Tests.
The health plan denied the requested therapeutic drug testing of anti-Adalimumab antibodies. 
The health plan's determination is overturned.


This patient is a female. She has a history of Crohn's disease. She previously tried and failed treatment with Mercaptopurine. She was then switched to Humira. She developed signs of active disease despite being on Humira. She was found to have a low Humira drug level and required dose escalation to weekly dosing. The patient required bowel surgery and many dosing changes based on the clinical picture and drug levels.
The requested service is Humira drug level and antibody assay.

I overturn the health plan's determination regarding the proposed health service or treatment.

Yes. Therapeutic drug level monitoring (TDM) has become an essential procedure in the management of inflammatory bowel disease. Measuring the drug level and the presence of antibodies can help the treating physician differentiate between primary treatment failures versus insufficient dosing. It can also allow dosing titration and adjustments.
The clinical practice guidelines adopted by the American College of Gastroenterology (ACG) support the use of therapeutic drug monitoring in the management of patients with inflammatory bowel disease. There is sufficient scientific evidence supporting the benefit of biologics drug level measurement. Per Namita Singh et al, "therapeutic drug monitoring allows for optimized, individualized dosing and improved care for inflammatory bowel disease (IBD) patients of all ages".

Mc Gettigan, Neasa, et al published a study concluding that therapeutic drug monitoring resulted in a significant reduction in hospital admissions, an increase in mean infliximab trough levels, a significant improvement in fecal calprotectin and adjustment to therapy in 33% of patients. Therapeutic drug monitoring was also associated with significant cost savings.

Finally, Samuel Raimundo Fernandes et al published a prospective study showing that proactive therapeutic drug level monitoring is associated with fewer surgeries and higher rates of mucosal healing than conventional non-TDM-based management.
Therefore, the requested service is effective and beneficial in the management of inflammatory bowel disease and is well supported by scientific evidence. There are no less costly or less invasive alternatives that would provide similar clinical information. Therefore, the requested service is medically necessary and appropriate.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Hyperhidrosis of the axillae, palms and soles. 
Treatment: Botox. 

The insurer denied the Botox. 
The determination is upheld. 

The patient has hyperhidrosis of the axillae, as well as the palms and soles. The patient has tried and failed topical Drysol and over-the-counter clinical strength deodorants without significant clinical improvement. The patient is sweating through multiple shirts and pairs of socks a day. She is also developing constant tinea pedis due to sweating.
Botox was denied for the treatment of the patient's hyperhidrosis of the axillae, palms, and soles. 

At issue is whether the non-formulary drug being denied is clinically appropriate for the patient's condition. 

No. Botox is not clinically appropriate for the treatment of this patient's primary axillary hyperhidrosis (having failed topical therapy), because there are no medical symptoms (rashes/dermatitis, infections, inability/decreased function for use of the arms and trunk) to warrant Botox as essential for this patient's physical/medical functioning. Accordingly, and particularly with body-wide involvement of the palms and soles, oral/systemic therapy should be used for daily use to treat the patient's axillary hyperhidrosis in a different mechanism of action than previous treatments used to date. 

Botox is Food and Drug Administration (FDA) approved and literature-supported [1-5] for primary axillary hyperhidrosis, but not for palmoplantar hyperhidrosis. Weakness of the palmar and plantar muscles, pain, and short/long-term efficacy are reasons why palmoplantar hyperhidrosis is normally treated with oral anticholinergics and/or topical medications and/or iontophoresis. 

For Botox to be medically necessary or indicated for the safe and efficacious treatment of the patient's palms and soles, alternative treatments would have to have been exhausted before such injections of Botox were used. Such is not the case at this time, and therefore for a global case of hyperhidrosis throughout this patient's body the use of oral/systemic combined with topical therapies is a more medically appropriate treatment approach at this time.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Prostate cancer. 
Treatment: Proton beam therapy. 

The insurer denied proton beam therapy. 
The health plan's determination is upheld. 

This is the case of a patient who presented with rising prostate-specific antigen (PSA). Biopsy established a diagnosis of intermediate risk prostate cancer. He was presented with different treatment options and is being evaluated for Proton beam radiation therapy (RT). This is the subject of review. 

Proton Beam Therapy (PBT) is not medically necessary for this patient. This is young patient with early stage, prostate cancer. The patient has several treatment options including surgery and radiation treatment for curative intent. Radiation treatment of such patient includes conventional IMRT, brachytherapy, proton beam therapy, SBRT (Stereotactic body radiation therapy) etc. Protons have been used to treat prostate cancer for the last several years. There are several clinical publications for safety and efficacy of proton beam RT for prostate cancer. However, there is no randomized trial suggesting superior clinical outcome of proton beam for prostate cancer over commonly used IMRT. Most investigators recommend additional study for long term safety and efficacy of protons compared with photons before adopting protons as medically necessary treatment for prostate cancer. 

Proton beam therapy is currently evaluated in several ongoing NCI (National Cancer Institute) approved clinical trials. 
The National Comprehensive Cancer Network (NCCN) guideline regarding proton therapy for prostate cancer refers to ASTRO's current position which states that "proton beam therapy for primary treatment of prostate cancer should only be performed within the context of a prospective clinical trial or within prospective registries." The NCCN panel believes there is no clear evidence supporting a benefit or decrement to proton therapy over IMRT for either treatment efficacy or long-term toxicity. 
There is a paucity of high-quality data comparing commonly implemented therapies for localized prostate cancer. There has never been a randomized trial directly comparing external beam radiation treatment delivery techniques There was inadequate evidence from comparative studies to permit conclusions concerning the impact of proton beam therapy compared with other treatments for prostate cancer.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Cancer. 
Treatment: Pharmacy/Prescription Drugs. 
The insurer denied mitomycin 40mg vial. 
The denial is overturned in whole.

This is a female with newly diagnosed anal carcinoma. The patient has stage IIB disease. Mitomycin has been recommended a component of therapy and is under review for medical necessity.

The requested mitomycin is medically necessary for this patient.

The need for mitomycin in curative treatment of anal cancer was addressed in a joint trial from the Radiation Therapy Oncology Group (RTOG) and the Eastern Cooperative Oncology Group (ECOG), in which 310 patients with anal cancer of any tumor or nodal stage were randomly assigned to combined modality therapy with or without mitomycin (using the Wayne State regimen). Patients who received mitomycin had significantly better four-year colostomy-free survival (71 versus 59 percent) and disease-free survival (73 versus 51 percent), but pathologic complete response rates and overall survival were similar. Grade 4 toxicity (23 versus 7 percent) and fatal neutropenic sepsis (4 versus 1 patient) were significantly more common in the mitomycin group. The authors concluded that, despite greater toxicity, the use of mitomycin in a definitive complete response regimen for anal cancer was justified. The National Comprehensive Cancer Network (NCCN) echoes this recommendation from the literature, as do the authors of UpToDate. For these reasons, the use of this agent in this clinical scenario is an established standard of care and fulfills criteria for medical necessity.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Osteoporosis.
Treatment: Personal Care Worker (PCW) Services Increase to 7 Days per Week x 12 Hours per Day.
 
The insurer denied the Personal Care Worker (PCW) Services Increase to 7 Days per Week x 12 Hours per Day. The health plan's determination is overturned. 

The patient is a female with past medical history of osteoarthritis, diabetes mellitus type 2 with neuropathy and insulin use, hypertension, hyperlipidemia, coronary artery disease, congestive heart failure, cerebrovascular accident (CVA) with left hemiparesis, urinary incontinence, overactive bladder, gastrointestinal (GI) bleed, low back pain, and gastroesophageal reflux disease (GERD) who had been assigned PCW (personal care worker) services. The patient had been hospitalized with shortness of breath and elevated blood pressure and transferred to rehabilitation. The patient was subsequently hospitalized from rehabilitation facility with breathing issues then returned to the rehabilitation facility. The patient underwent cardiac catheterization with intervention. The patient underwent a telephonic assessment while planning for discharge from rehabilitation. The patient was assessed at total assistance with ordinary housework, managing finances, stairs, and shopping while maximum assistance with tasks of meal preparation, managing medication, transportation, bathing, dressing lower body, walking, locomotion, and transfer toilet. The patient was assessed at extensive assistance with tasks of personal hygiene, dressing upper body, and toilet use while limited assistance with bed mobility and eating.

Personal Care Worker (PCW) Services Increase to 7 Days per Week x 12 Hours per Day is medically necessary for this patient. 

The patient had worsening functional status following her hospitalization with resultant chair and bed bound status. The patient requires at least some assistance with all activities of daily living (ADL) / Instrumental activities of daily living (IADL) tasks but maximum assistance with locomotion, walking, and transfer toilet. The patient has unscheduled and unpredictable care needs that span a continuum of time, and the insurer failed to document a plan to address these unscheduled and unpredictable care needs. The patient has decrease in the ability of her husband to perform informal support and this was not taken into account when calculating PCW hours. The patient's increase in care needs cannot be met solely with adaptive equipment and medical supplies. The increase in PCW hours is not solely for safety and supervision but to assist the patient with safe completion of ADLs/IADLs. Taking into account the clinical standards, all information provided regarding the patient, the attending physician's recommendations, and the applicable and generally accepted practice guidelines, Personal Care Worker (PCW) Services Increase to 7 Days per Week x 12 Hours per Day are medically necessary for this patient. Personal care services are medically necessary when assistance with nutritional and environmental support function is essential to the maintenance of the patient's health and safety in her own home.
Appeal type: Medical necessity
Decision: Overturned

Mental Health
Mental Health: Inpatient

Diagnosis: schizophrenia
Treatment: Inpatient Mental Health Treatment 
The insurer denied Inpatient Mental Health Treatment. The health plan's determination is overturned. 

The case involves a male diagnosed with unspecified schizophrenia and co-occurring substance use disorders (cocaine, cannabis, MDMA (Methylenedioxymethamphetamine) and tobacco). He was admitted to acute inpatient level services with severe symptoms of psychosis with agitation, and neglect of self-care and hygiene. Additionally, the patient has a history of non-compliance with treatment and non-adherence with medications, and had no follow-up with his outpatient clinicians after discharge from the hospital approximately two weeks prior to presentation. He had been brought in by emergency services after barricading himself in a room at his shelter.
The patient has a history of multiple prior admissions for psychiatric treatment, and had been in outpatient treatment with intensive case management services. Again, the patient had been non-adherent with medications and non-compliant with outpatient treatment in the context of active substance abuse.

Inpatient Mental Health Treatment is medically necessary for this patient.
The patient's symptoms of psychosis due to an exacerbation of schizophrenia and co-occurring substance use, as well as non-compliance with treatment prompted the necessity for the admission and warranted the continued acute inpatient level structure and monitoring through discharge. The case is complicated by active substance use disorders; and non-compliance with treatment and medication adherence problems in the context of substance use with stimulant and cannabis class substances of abuse. The residual symptoms of the chronic psychotic disorder; risk for relapse, co-occurring substance use disorders, and treatment issues related to non-compliance/non-adherence with medications and the need for arranging a safe and clinically appropriate discharge plan warranted the continued services at an acute inpatient level of care to include safety monitoring and maintaining abstinence from substances of abuse.
Thus, the continued inpatient stay thru discharge was clinically appropriate and medically necessary in order to provide the necessary and the continued inpatient level structure and 24-hour monitoring through the day of discharge when the patient had reached a level of stability that he could return to the community with community level services and with clinically appropriate follow-up and aftercare.
Appeal type: Medical necessity
Decision: Upheld

Central Nervous system/Neuromuscular disorder
Home Health Care

Diagnosis: Multiple Sclerosis
Treatment: PCA (personal care assistant) services 
The insurer denied Personal Care Services: 12 Hours per Day, 7 Days per Week (Live-In). The health plan's determination is upheld. 

The patient is a male with a past medical history significant for multiple sclerosis. This review is for medical necessity of an increase in personal care services 12 hours per day 7 days a week (live in). The patient is currently approved for 8 hours a day 7 days a week for a total of 56 hours a week of services.

The Increase in Personal Care Services: 12 Hours per Day, 7 Days per Week (Live-In) is not medically necessary for this patient.
The services currently being provided are adequate to meet the patient's needs. Additional hours are not medically necessary. The patient lives in a facility that has 24-hour housekeeping and laundry services. They also have a registered nurse, and medical technician certified aides providing additional services.
The HELPS - assessment recommended a total of 54 hours per week.
The Uniform Assessment System (UAS) State of New York noted that his overall self-sufficiency has significantly decreased in the last 90 days.
The patient was hospitalized in January secondary to Covid 19 which affected his physical stamina. He is essentially non-ambulatory at this time.
The patient has significant disability secondary to the multiple sclerosis including progressive neurological disease. He is dependent on others for all of his Instrumental activities of daily living (IADL) and the majority of his activities of daily living (ADL). He has been approved for 56 hours a week which meets his medical needs as listed on the UAS. It appears that the 2 needs that cannot be met on a scheduled basis include incontinence needs and positioning. As for his incontinence, it is recommended that the patient use a Texas catheter which he did use in the skilled facility. This should help alleviate issues with urinary incontinence. Also, supplies are available for fecal incontinence if necessary. There is no medical reason such as a decubitus ulcer which would require him to be turned frequently by a health aide. The facility he lives at provides an RN, medical technician and also laundry and housekeeping services. His other needs are met through the PCA (personal care assistant) services as listed in the UAS. Splitting the PCA services, 8 hours a day 7 days a week into 2 shifts may also better meet his medical needs.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Digestive System/Gastrointestinal. 
Treatment: Inpatient Hospital. 
The insurer denied inpatient stay. 
The denial is overturned.

The patient is a  female who presented to the emergency department (ED) with a history of progressively worsening abdominal pain over a period of 2-days. She had a history of prior laparoscopic appendectomy performed two weeks prior at another facility. Evaluation included physical exam, labs, and computed tomography (CT) scan. The patient was without fever at the time of presentation. The heart rate was 69/minute. Lab data identified an elevated white blood cell (WBC) count of 13 thousand (K). Blood urea nitrogen (BUN) and creatinine (Cr) were normal at 13 and 0.7. CT scan identified pericolonic inflammatory change in the area of the cecum and an adjacent fluid collection consistent with abscess. Treatment was initiated with intravenous (IV) fluid and antibiotics. Surgical consultation was obtained on the day of presentation.

Acute inpatient admission was medically necessary for this patient.
This patient presented with abdominal pain in the setting of prior appendectomy 2-weeks earlier performed at another facility. Evaluation with examination, lab data, and CT scan confirmed the diagnosis of a post-surgical abscess in the right lower quadrant. The initial treatment appropriately included nothing by mouth (NPO) status, IV fluid, and IV antibiotics. The patient was considered for percutaneous, image-guided drainage, but this was not an option per the radiologist. Consequently, a non-operative treatment approach with NPO status, IV fluid and IV antibiotics was provided. The subject under review is the medical necessity for the inpatient stay. 

The submitted clinical documentation does support the need for inpatient admission for this patient. The patient required urgent surgical evaluation, follow up lab data, provision of IV antibiotics, and IV fluid during the period of NPO status. It was anticipated that this treatment would span a period of greater than 48-hours. Inpatient care is indicated in the setting of peritoneal signs or other signs or symptoms of acute abdominal disease. In this case, the patient had significant right lower abdominal pain and tenderness at the time of presentation and was found to have an intra-abdominal infection due to a post-surgical abscess. Inpatient care was medically necessary for this patient on the specified dates in order to provide the prescribed therapy with parenteral medication and close follow up given the possibility of clinical deterioration.
The nonsurgical treatment for the diagnosis of an early post-appendectomy intra-abdominal abscess that was provided was most appropriately provided with an inpatient level of care.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Rule out pulmonary embolism; possible cellulitis.

Treatment: Inpatient hospital admission.

The insurer denied coverage for the inpatient hospital admission.

The denial is overturned. 

This is a male patient with past medical history significant for Protein S and C deficiency, Factor V Leiden, pulmonary embolism, deep vein thrombosis (DVT), and asthma who presented to the Emergency Department (ED) with complaints of pain and swelling of the right cheek and left thigh. He also reported shortness of breath.

Vital signs on presentation included: Temperature- 97.5, Blood Pressure- 139/87, Pulse- 107, Respiratory Rate- 18, Oxygen (O2) saturation- 99% on Room Air. Laboratory results included the following: White blood cell (WBC) count- 6.9, hemoglobin (HGB)- 13.5, hematocrit (HCT)- 41.1, creatinine- 0.71, and glucose- 89.

The patient was admitted to the hospital to rule out pulmonary embolism and treatment of possible cellulitis. He was started on broad-spectrum antibiotics (vancomycin, aztreonam, and metronidazole). Computed tomography (CT) scan of the lower extremity showed left anterior and medical thigh soft tissue edema suggestive of cellulitis. CT scan of the sinuses showed soft tissue swelling in the right side of the face. Dental radiographs showed multiple dental caries. The patient underwent dental extractions. He was treated with Fondaparinux but refused lung ventilation-perfusion scan as well as a duplex ultrasound. The patient ultimately signed out against medical advice (AMA).   

The patient presented with possible infection of the right cheek and thigh with some pus drainage. Additionally, he reported shortness of breath, and a "sharp, right sided chest pain" worse with inspiration, similar to his prior episodes of pulmonary embolism. Vital signs did show tachycardia. Based on above findings in a high-risk patient with multiple co-morbid conditions who was non-compliant with his outpatient medications, hospital admission was medically necessary for antibiotics and additional diagnostic testing (which he refused). 

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

The insurer's denial of coverage for the inpatient hospital admission is overturned.  Medical necessity is substantiated.