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



Diagnosis: multiple sclerosis
Treatment: home health care
The insurer denied Consumer Directed Personal Assistance Services (CDPAS): 24 Hours of Continuous Care with 12-Hour Split Shifts, 7 Days per Week. 
The health plan's determination is overturned. 

This is a case review for a female with medical history notable for multiple sclerosis, mobility issues, and bladder incontinence. The patient and her care team requested an increase to 24 hour continuous care with 12 hour split-shifts, 7 days per week.

The requested Consumer Directed Personal Assistance Services (CDPAS): 24 Hours of Continuous Care with 12-Hour Split Shifts, 7 Days per Week is medically necessary for this patient.
The patient's multiple sclerosis has resulted in severe limitations in performing activities of daily living (ADL) and Instrumental activities of daily living (IADL). She is dependent on others for all tasks, including toileting and bed mobility. She is incontinent of urine. Her husband has been providing informal support during the time that the patient does not have an aide available, but he will be undergoing major surgery in the near future. The patient is essentially bedbound without an aide available. The patient's personal care needs can be expected to be continuous in nature and unscheduled. She will require assistance throughout the day and night to help with toileting, bed mobility, and other personal care tasks.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Functional impairment
Treatment: Personal Care Aide (PCA): 12 hours/day, 7 days/week, total of 84 hours/week
The insurer denied coverage for PCA: 12 hours/day, 7 days/week, total of 84 hours/week.
The denial is overturned. 

The patient is an elderly female. The issue is one of coverage of personal care aide (PCA) 12 hours/day, 7 days/week, total of 84 hours/week. The patient has a history of falls. 

Based on the medical records available for review, this individual is highly dependent upon assistance for activities of daily living (ADLs) which include all of her functions. She clearly needs help even during nighttime. As such, the requested 12 hours/day, 7) days/week assistance is medically necessary for the patient's health, function, and ADLs. 

"When friends and family are unavailable or unable to care for homebound loved ones, primary care often deploys Home and Community Based Services, including home health aides. For these homebound older adults, home health aides are essential to help preserve an independent life at home and avoid nursing home care." (D'Cruz, L., et al, 2022)

"Millions of older adults and adults with chronic conditions and disabilities in the United States depend on home care workers to remain at home and age in place. Home care workers, which include home health aides, attendants, and personal care aides, provide assistance with personal care (activities of daily living and instrumental activities of daily living), medically oriented care, and emotional support." (Shaw, A. L., et al, 2022)

Tension exists for patients between the desire of being comfortable in the familiar setting of home, the need for treatment of ongoing illness, and advances in medical technology and health care delivery systems. This tension is a relatively recent occurrence and is associated with the industrialization of medical care into larger institutional settings. Home health care serves an important role in lessening this tension by providing much of the benefit of modern medical care in the home setting. Home care often best meets patients' emotional needs during their experience of illness. 

"Home care can lessen the need and challenge of gaining access and travel to physician offices and/or medical care facilities. An increasing number of basic and sophisticated services are being provided by home health care agencies coupled with improvements in technology available in the home. With value-based purchasing and other changes in health care finance, home care is potentially an attractive means of lowering institutional costs and keeping health care costs low. There is evidence that for select patients, care at home can be as good or better than care in a hospital/clinic; this improves quality of life for patients and lowers costs for the payers." (O'Dell, M., & Wheeler, L. M., 2012) 

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably, with sound medical judgment, or in the best interest of the patient. 

The medical necessity for PCA: 12 hours/day, 7 days/week, total of 84 hours/week is substantiated.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Mucormycosis
Treatment: Posaconazole Delayed-Rel (release)Tablet
The insurer denied coverage for Posaconazole delayed-rel tablet.
The denial is overturned.
 
This patient is an adult with past medical history significant for Hodgkin's lymphoma, status post chemotherapy, status post splenic artery embolization, hospitalized for worsening shortness of breath. Infectious Diseases was consulted for right upper lobe cavitary lesion. Patient underwent interventional radiology (IR)-guided biopsy and fungal elements were noted on gram stain suspicious for pulmonary mucormycosis. Decision was made by the Infectious Diseases consultant to initiate Posaconazole. 

At issue is the denial of coverage of Posaconazole delayed-release tablet for formulary exception. Formulary alternatives are: fluconazole, itraconazole, voriconazole, Noxafil (Posaconazole) injection, Noxafil (Posaconazole) suspension. Requirement: Trial and failure of all the formulary alternatives, but not more than three.

Posaconazole is an azole antifungal initially approved by the Food and Drug Administration (FDA) as an oral suspension. Delayed-release tablets and injection were approved in November and March, respectively. Posaconazole is a broad-spectrum azole that's active in vitro against the agents of mucormycosis and are available in both parenteral and oral formulations.

Delayed-release Posaconazole [300 milligrams (mg) every 12 hours on the first day, then 300 mg once daily] taken with food, if possible, is clearly the preferred option compared to formulary option Noxafil (Posaconazole) suspension. Noxafil suspension is not highly bioavailable and requires fatty food for absorption. Clinical studies support the use of delayed-release Posaconazole to treat mucormycosis, a very serious invasive fungal infection. 

The formulary drugs are not expected to cause adverse effects. 

The formulary drugs were not tried, and the patient did have an adverse reaction or contraindication.

The formulary drug is expected to be ineffective.

The non-formulary drug is expected to be more effective than the formulary alternatives.

The carrier's denial of a request for a formulary exception for Posaconazole delayed-rel (release) tablet to treat mucormycosis is overturned.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Asthma. 
Treatment: Inpatient admission. 
The insurer denied coverage for inpatient admission. 
The denial is overturned. 

This is a male child with a past medical history of asthma. He was sick for one day with a cough, wheezing and shortness of breath. There was one episode of post tussive (coughing) vomiting. When his difficulty with breathing did not improve with administration of several doses of albuterol at home, he was brought to the emergency room by emergency medical service (EMS). During the transport he was administered 2 doses of inhaled Combivent. There was a history of 5 previous hospitalizations for asthma. Three of these admission required care in the pediatric intensive care unit (PICU). He was maintained on twice daily Symbicort to control his asthma. 

In the emergency room (ER) he was noted to be in respiratory distress with retractions and bilateral wheezing with decreased breath sounds noted. He was treated with 2 additional treatments with Combivent and three additional treatments with albuterol. He was also treated with dexamethasone, magnesium sulfate and a bolus of normal saline. A chest X-ray was normal. A blood gas was abnormal. When his wheezing did not improve, the decision was made to admit the child with a diagnosis of status asthmaticus for continued treatment with albuterol every 3 hours. 

The patient was treated appropriately at the emergency room (ER) for his acute episode of asthma. He had many previous hospitalizations for asthma and was on daily anti-inflammatory therapy with Symbicort. His blood gas and serum bicarbonate level were abnormal and were concerning for a risk of respiratory failure in this child with multiple previous hospitalizations for asthma. This child with moderate persistent asthma did not respond to treatment in the emergency room (ER) and the decision to admit for albuterol every 3 hours was appropriate and consistent with the standard of care for status asthmaticus. The child with many previous admissions for asthma was not stable enough to be discharged safely. 

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for the inpatient hospital admission is substantiated.
Appeal type: Experimental/Investigational
Decision: Overturned

Orthopedic/ Musculoskeletal/Back Pain/ Low Back Pain
Surgical Services (All)/Intraosseous Basivertebral Nerve Ablation
The health plan denied the requested treatment as experimental/investigational. The health plan's determination is overturned.

This is a male who has a history of lower back pain. His pain is localized in the lower back with no radicular symptoms. This pain has becomes increasingly severe in the past 6 months. Pain level is 5/10 with activities. Prolonged sitting, going from sitting to standing, and forward flexion increase his pain. He has restricted his activities such as exercise due to back pain. A physical exam (PE) was unremarkable. A magnetic resonance imaging (MRI) revealed Modic changes at (lumbar) L4 L5 and (sacral) S1 with mild disc bulges at L4/5 and L5/S1.

The issue is whether the proposed health service or treatment of an Intraosseous Basivertebral Nerve Ablation is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

I overturn, in whole, the health plan's determination.

The INTRACEPT system was designed to treat low back pain from vertebral body by ablating basivertebral nerves. From reviewing the medical records and current clinical studies, this patient has persistent symptoms consistent with vertebrogenic pain despite prior conservative treatments. There are multiple clinical trials demonstrated the sustained improvements in pain and function from this intervention for patients with vertebrogenic pain. This patient had failed extensive treatments including Chiropractic manipulation, non-steroidal anti-inflammatory drugs (NSAIDs) and muscle relaxers. His pain is severe enough with a negative impact on his activities of daily living (ADL). Further interventions are medically necessary to improve his pain and function. Other potential treatment options are long-term use of medications (NSAIDs, opioids) and lumbar decompression fusion surgery. However, none of these options has a high success rate, and all of them carry significant risks and complications. Given this clinical scenario, an Intracept procedure is likely to be more beneficial than any standard treatments for the insured's disabling condition. Intracept procedure is medically necessary as the next step intervention.
Appeal type: Experimental/Investigational
Decision: Overturned

Orthopedic/ Musculoskeletal/Back Pain/ Low Back Pain
Surgical Services (All)/Intraosseous Basivertebral Nerve Ablation
The health plan denied the requested treatment as experimental/investigational. The health plan's determination is overturned.

The patient is a male with a history of chronic low back pain. A magnetic resonance imaging (MRI) of the lumbar spine revealed degenerative Modic changes from (lumbar) L3 to (sacral) S1. They have been treated with Flexeril and chiropractic care. His treating physician would lie to perform the Intracept procedure.

At issue is whether the proposed health service or treatment of an Intraosseous Basivertebral Nerve Ablation is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

The health plan's determination is overturned, in whole.

The proposed health service or treatment Intraosseous Basivertebral Nerve Ablation is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

Intracept is a minimally invasive procedure that targets the basivertebral nerve for the relief of chronic vertebrogenic low back pain. A review of available up-to-date publications utilizing basivertebral nerve (BVN) ablation in the treatment of vertebral pain suggests that there is quality evidence that this is an effective intervention for reduction of disability and improvement in function, at short- and long-term follow-up, in addition to evidence that BVN radiofrequency ablation (RFA) is superior to conservative care for pain reduction, at least at 3-month follow-up. Also there is a highly clinical and statistically significant treatment effect of BVN ablation for vertebral pain with clinically meaningful benefits in pain reduction, functional improvements, opioid dose reduction, and improved quality of life. There were no reported device-related patient deaths or serious adverse events (AE) based on the available literature. BVN ablation is a safe, well-tolerated and clinically beneficial intervention for vertebral pain, when proper patient selection and surgical/procedural techniques are applied.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Back Pain.
Treatment: Intraosseous basivertebral nerve (BVN) ablation.
The insurer denied Intraosseous basivertebral nerve (BVN) ablation.  
The determination is upheld.

This is a female patient with a diagnosis of low back pain. The provider requested approval for the Intracept procedure (intraosseous basivertebral nerve ablation). Letters of appeal were submitted. The provider notes that the patient has a history of chronic low back pain and has failed multiple treatments including home exercise, injections, lumbar epidural injections, medial branch blocks, medication management, physical therapy, sacroiliac joint injections and chiropractic care. Medications have included ibuprofen, lidocaine patch, medical marijuana, tizanidine and Tylenol. The pain is impacting the patient's activities of daily living such as bending, lifting, home exercises, sitting and sleeping. Nothing has provided significant or sustained relief. The provider states the patient had a magnetic resonance imaging (MRI) scan showing Modic changes at disc spaces lumbar (L) 3, L4, L5 and sacral (S) 1 and feels that this is the source of the patient's chronic back pain.

At issue is whether intraosseous basivertebral nerve ablation (BVN) is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

There is no evidence that the proposed health service or treatment intraosseous basivertebral nerve ablation is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
The patient is noted to have complaints of chronic back pain and SI joint pain. The provider stated on appeal that the patient had an MRI on  showing Modic changes at disc spaces L3, L4, L5 and S1 and feels that this is the source of the patient's chronic back pain. However, the lumbar spine MRI does not mention any Modic changes or degenerative endplate changes. The patient does, however, have a disc herniation at L3 - L4 and varying levels of neural foraminal narrowing and facet arthrosis, which are likely pain generators. There are a lack of high quality studies evaluating the long-term risks and benefits of the requested procedure. Although some results have been promising, additional studies are needed to establish the safety and efficacy.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Back Pain.
Treatment: Intraosseous basivertebral nerve (BVN) ablation.
The insurer denied Intraosseous basivertebral nerve (BVN) ablation.  
The determination is upheld.

This is a female patient who has chronic low back pain. She has pain in the back and buttocks, left greater than right, with pain into the left hip and lateral thigh. Her pain is worse with changing positions and forward flexion. The pain level is 9/10. The physical exam (PE) was unremarkable except for decreased range of motion (ROM) of the lumbar spine and tenderness to palpation (TTP). She had tried physical therapy (PT), pain medications and lumbar epidural injections without success. Lumbar spine magnetic resonance imaging (MRI) revealed left lumbar (L) 3/4 foraminal disc herniation and L4/5 bilateral foraminal stenosis with moderate facet arthrosis. This patient was recommended for an Intracept procedure. At issue is whether intraosseous basivertebral nerve ablation is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

No. The Intracept system is designed to treat low back pain from the vertebral body by ablating basivertebral nerves. The available medical records did not reveal adequate evidence that this patient's pain is from L3, L4, L5, and sacral (S) 1 vertebral bodies. Lumbar spine MRI revealed left L3/4 foraminal disc herniation and L4/5 bilateral foraminal stenosis with moderate facet arthrosis. Truumees's study supported the efficacy of the Intracept procedure. However, patients with radiographic evidence of other pain etiologies including disc bulge, spinal stenosis and facet arthrosis were excluded. Ref 1. (Table 1 exclusion criteria in this study).

Given this patient's clinical presentation, MRI findings, and the evidence from current clinical studies, it is unlikely this patient will benefit from the Intracept procedure at L3 L4 L5 and S1 levels.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Gynecomastia
Treatment: Outpatient Surgery (19300 X 1)
The insurer denied coverage for outpatient surgery (19300 X 1).
The denial is upheld. 

The health plan acted reasonably and with sound medical judgment. The outpatient surgery is not medically necessary. The patient has a history of gynecomastia for four years. Mammogram shows no signs of malignancy. The records do not document an endocrine work-up. The plastic surgeon's note describes breast pain that is intermittent. The pediatrician exam indicates breasts are enlarged but non-tender. Several pediatrician notes are submitted spanning several years. None of these notes documents complaints of pain or interference with activities of daily living due to gynecomastia. The patient is said in the plastic surgery notes to suffer from low self-esteem due to the enlarged breasts, but the pediatrician notes do not document issues with low self-esteem due to gynecomastia. A psychologist or counselor has not evaluated the patient for issues related to low self-esteem. There is no documentation of attempts at medical management. According to Berger, "Tamoxifen was the chosen drug of treatment in most of the reviewed studies and found to be effective, safe, and with minimal side effect. Pharmacological treatment as a new standard of care has an advantage in relieving behavioral and psychological distress. Although high quality publications are lacking, pharmacological intervention with Tamoxifen is appropriate in select patients." The breast surgery will primarily change appearance and is not necessary for health or function.

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably, with sound medical judgment, and in the best interest of the patient. 

The medical necessity for outpatient surgery (19300 X 1) is not substantiated.
Appeal type: Medical necessity
Decision: Overturned in Part

Diagnosis: Gender Dysphoria
Treatment: Gender Affirming Surgery
The insurer denied: Gender Affirming Surgery
The denial is partially overturned.

The patient is an adult male-to-female with a history of gender dysphoria. The patient desires chin revision and breast augmentation. She has been socially transitioning over the past five and a half years. She has been transitioning medically, taking hormone replacement therapy for greater than four years.
The only gender-affirming procedure has been electrolysis. She did have Facial feminization with
1) Frontal sinus reduction and setback;
2) Medial supraorbital rim reduction;
3) Vertical reduction of the lateral orbital rim as well as forehead reduction, frontal bone;
4) Bilateral browlift;
5) Fat grafting to the lips and cheeks;
6) Osseous genioplasty;
7) Bilateral mandible angle reduction;
8) Open rhinoplasty.

The patient reports that the male appearance of her chin, lips, chest and exacerbate her gender dysphoria and cause misgendering. Her surgeon recommends breast augmentation and chin genioplasty revision.

The requested gender affirming surgery is medically necessary, in part.

Specifically, the breast augmentation is medically necessary. However, the genioplasty revision is cosmetic and not medically necessary.
Per the World Professional Association for Transgender Health (WPATH) "Standards of Care for the Health of Transsexual, Transgender, and Gender- Nonconforming People" 7th Edition 
guidelines:
Criteria for Breast/Chest Surgery (One Referral)
Criteria for breast augmentation (implants/lipofilling) in MtF (male to female) patients:
1) Persistent, well-documented gender dysphoria;
2) Capacity to make a fully informed decision and to consent for treatment;
3) Age of majority in a given country (if younger, follow the SOC (standard of care) for children and adolescents);
4) If significant medical or mental health concerns are present, they must be reasonably well controlled.

Although not an explicit criterion, it is recommended that MtF (male-to-female) patients undergo feminizing hormone therapy (minimum 12 months) prior to breast augmentation surgery. The purpose is to maximize breast growth in order to obtain better surgical (aesthetic) results.
The patient meets these guidelines. She has well documented gender dysphoria and has been on hormone therapy for years. Breast growth with hormone therapy has been maximized. She is the age of majority. Significant mental health concerns are not documented. The requested breast augmentation is consistent with the WPATH (World Professional Association for Transgender Health) criteria and is medically necessary.
The genioplasty revision is cosmetic. The patient has already had a feminizing genioplasty. The records do not include photos that show that the patient's chin appearance deviates significantly from feminine form such that revision is a required treatment for her gender dysphoria. The genioplasty revision, therefore, is not medically necessary.