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

Diagnosis: Crossbite
Treatment: Braces
The insurer denied braces.
The denial is overturned.
The Braces are medically necessary.

The patient has a crossbite of an anterior tooth (#27, lower right canine) with attachment (gum) loss. This is an automatic qualifying condition according to the handicapping index scale. Orthodontic treatment is medically necessary to correct this problem.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Cardiac/circulatory problems. 
Treatment: Pharmacy/Prescription Drugs. 

Diagnosis: Cardiac/Circulatory Problems/Chest pain. 
Treatment: Prescription drugs/Ranexa. 
The health plan denied the non-formulary medication as not medically necessary. The health plan determination is upheld in whole. 

The patient has hypertension, hyperlipidemia, and coronary artery disease. The patient is an active cigarette smoker and has had multiple percutaneous coronary interventions. The patient has continued exertional chest pain despite treatment with metoprolol 25 mg twice daily. The patient has been intolerant to amlodipine, Imdur and nebivolol. The patient was previously treated with extended release Ranexa but has not been taking it recently. At issue is whether the formulary drug will be ineffective, has been ineffective, or would not be as effective as the non-formulary drug, or would have adverse effects. The non-formulary drug is brand name Ranexa Extended Release. 

The formulary alternative is generic extended release ranolazine. Based on the information provided, it does not appear as if this patient has had a trial of generic ranolazine. The bioequivalence between Food and Drug Administration (FDA) approved brand-name and generic cardiovascular drugs has been well demonstrated. FDA standards for bioequivalence of generic drugs are stringent; approval is not granted until similar safety, efficacy and bioavailability to the original brand name drug is clearly demonstrated. Moreover, some studies have documented improved patient compliance with generic as opposed to name-brand drugs since the former are more affordable. For these reasons, best practice advice from the American College Physicians is for physicians to prescribe generic drugs whenever possible. In the absence of intolerance to generic ranolazine, or clear inefficacy as compared to the brand-name version, there is no medical reason to prefer the brand-name version over the generic drug.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Ventriculoperitoneal (VP) shunt infection. 
Treatment: Continued sub-acute rehabilitation skilled nursing facility (SNF) services. 

The insurer denied coverage for continued sub-acute rehabilitation skilled nursing facility (SNF) services. 

The denial is upheld. 

This is a male patient with multiple chronic medical problems including cerebral palsy, hydrocephalus, epilepsy, and intracerebral hemorrhage right hemiplegia. The patient was admitted for subacute rehabilitation after being hospitalized due to ventriculoperitoneal (VP) shunt infection. Therapy was suspended after 3 months of therapy due to Covid-19 positive precautions. Therapy eventually resumed 5 weeks after being suspended and has continued for 11 weeks since then. 

Clinical records do not demonstrate a level of functional improvement to support the medical necessity of continued therapy/rehabilitation services at the skilled nursing facility (SNF) after week 11 of resumed therapy. While the suspension of therapy due to Covid-19 positive precautions has been noted, the patient received more than 5 months of therapy. According to physical therapy notes, the patient remains at the minimal assistance level for bed mobility and is ambulating with a platform walker (and assistant of another person). Similar lack of improvement is documented by the occupational therapist.  Activities such as toileting, hygiene and lower body dressing continue to require maximal assistance. In addition, there were no nursing or physician notes documenting any specific complex nursing needs or acute medical issues, respectively that require ongoing inpatient skilled nursing or medical services. 

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

From a physical medicine and rehabilitation perspective, as well as within a reasonable degree of medical certainty, continued subacute rehabilitation SNF services are not medically necessary. 

The carrier's denial of coverage for continued sub-acute rehabilitation SNF services is upheld. The medical necessity is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Cerebral Palsy.
Treatment:  40 hours per week of consumer directed personal assistance services.

The insurer denied 40 hours per week of consumer directed personal assistance services.  The determination is upheld.

The patient has cerebral palsy, epilepsy, severe intellectual disabilities and hypothyroidism.  She is unable to communicate with others, and cannot feed, dress or bathe herself.  They recommended that she have a caregiver with her 24 hours a day, 7 days a week to assist with her daily needs.  An undated medical report indicates that she is taking levothyroxine 50 micrograms, Keppra 3 milliliters (ml) twice a day, and valproate 100 milligrams (mg) twice a day.  

Her health plan has approved a Personal Care Aide for 13.75 hours per week; 2.75 hours per day for 5 days.

At issue in this review is whether 40 hours per week of consumer directed personal assistance services is medically necessary for the patient.

The requested 40 hours per week of consumer directed personal assistance services is not medically necessary for the patient.  

The Task-Based Assessment Tool and Uniform Assessment System - New York Comprehensive Pediatric 4-17 Assessment Report was performed.  The report described that the patient lives with her mother in a 2-bedroom apartment that has an elevator and is wheelchair accessible. She usually attended school with a 1:1 aide; she is not currently attending school due to Covid 19.  She is described as requiring extensive assistance for eating, bathing, personal hygiene and dressing, and maximal assistance for toilet use and managing medications.  An average of 1.25 hours service hours were calculated to be required each.

The health plan has approved a Personal Care Aide for 13.75 hours per week; 2.75 hours per day for 5 days.  This is medically appropriate, so that assistance can be provided for age-appropriate tasks, which the patient is unable to perform due to her underlying medical problems, which include intellectual disabilities and cerebral palsy.  These activities of daily living include bathing and dressing [1,2].  Consumer directed personal assistance services are not to be used for supervision, childcare or to replace normal parental duties.  The requested 40 hours of consumer directed personal assistance services are not medically necessary.

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

Diagnosis: Skin cancer
Treatment: MOHS Micrographic Surgery 
The insurer denied the MOHS Micrographic Surgery.
The denial is overturned. 

The patient is a female. The patient had two squamous cell carcinomas, keratoacanthoma type, which were treated with Mohs surgery. The need for the surgery during COVID (Coronavirus Disease) restrictions is under review.

Yes, the patient's condition was emergency in nature such that the MOHS Micrographic Surgery provided by the out-of-network providers was medically necessary.

Keratoacanthoma type squamous cell carcinoma is characterized by rapid growth over a few weeks to months. It is destructive and, although it rarely metastasizes, it can lead to severe damage to the structures where it occurs. This patient had one on the dorsal nose, extending onto the skin of the eyelid (very sensitive area for surgery and reconstruction), and the other on the arm. Waiting months for the COVID restrictions to ease up could have resulted in a much bigger defect and need for more extensive surgery and reconstruction.

This procedure was medically necessary and required urgent care due to the nature of the disease.
Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Low back pain. 
Treatment: 22899 - Intracept procedure. 
The insurer denied the 22899 - Intracept procedure. 
The denial is overturned. 

The patient is a female with a history of chronic low back who has failed multiple alternatives and is trying to avoid surgery. Intercept procedure has been recommended. 

Yes, the health plan should cover the Intracept procedure. 

Yes, the requested health service or procedure is likely to be more beneficial than standard treatments. 

The patient is a female with chronic low back pain who continues to have low back pain despite multiple interventions. She has failed medications, physical therapy (PT), home exercise, epidural injections, facet joint injections, and radiofrequency ablation. She is looking for an alternative to surgery/fusion. 

The Intercept procedure (interosseous basovertebral nerve ablation) is not and intradiscal procedure. It is a new FDA approved intraosseous nerve ablation for the treatment of chronic low back pain in the treatment of vertebrogenic related chronic low back pain. It is typically used in patients with significant Modic type-1 or type-2 vertebral endplate changes. 

This patient is quite young; the alternatives, such as spinal fusion, do not have good long-term results in the literature. Spinal fusion in young patients is typically not recommended and sought to be avoided. It is a very invasive procedure with high morbidity and poor outcomes. Most recent articles show less than 50 percent improvement for the treatment of chronic low back pain with spinal fusion. Therefore, the options are limited. Spinal cord stimulation is an alternative, however, has not been shown to have excellent results in primarily axial mechanical/discogenic type pain. Opioids are best avoided for chronic low back pain, especially in a young patient. Therefore, the intercept  procedure is a reasonable option. It is FDA approved. Randomized studies are available with good outcomes, at up to two years. 

The Intracept procedure is not to be confused with an intradiscal procedure, which have not shown to have good results in the literature. Since there is no Medicare approved code (CPT code) for this procedure, the health plan has chosen a code for an intradiscal procedure however this does not accurately describe the requested procedure. Given that the alternatives do not show favorable outcomes in the literature, have higher risk, and morbidity, the requested Intercept procedure is appropriate.
Appeal type: Formulary Exception
Decision: Upheld

The patient is requesting coverage for Kombiglyze extended release (XR). In an appeal letter the attending physician writes that the patient was unable to tolerate multiple medications including Januvia, Jentadueto, Tradjenta, metformin ER, and glipizide XL. A progress note included a medication list that included Jentadueto, metformin ER, Tradjenta, Kombiglyze XR, and glipizide XL. Patient offered no complaints and the plan was to continue the present regimen. Subsequently, in another progress note there is a medication list that includes metformin ER, Kombiglyze, and glipizide XL. The patient had no complaints. Once again, the plan was to continue the present regimen. The HP determination is upheld in whole. It has not been established the formulary drugs Janumet XR or Jentadueto XR will be or have been ineffective. Nor has it been established that the formulary drugs would have adverse effects. The standards of care dictate that it be clearly documented in the medical record when a medication or medications have been ineffective in a patient and/or have caused intolerable side effects. In this case, the two progress notes included for review do not clearly document what medication changes were made, when the changes were made, and why they were made. There is no medical record documentation to support the attending physician's contention that the formulary approved medications caused adverse effects. In addition, there is no evidence that the patient tried and failed the very large number of older established medications for diabetes. Therefore, the medical necessity of the non-formulary product, Kombiglyze, has not been credibly established.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Status post bilateral total patella button revision

Treatment: Inpatient hospital admission

The insurer denied coverage for inpatient hospital admission. The denial upheld.

This patient is a male with a history of coronary artery disease status post 2 vessel drug eluting stent in the right coronary artery (RCA) essential hypertension, hyperlipidemia, carotid stenosis status post carotid stent, obesity, osteoarthritis, Gilbert's disease, bilateral knee replacements, left total knee arthroplasty revision over a decade ago, and right knee periprosthetic infection status post recent uncomplicated bilateral total patella button revision.

He presented to the hospital with concern for right knee infection.  He had developed drainage, chills and fever.  He had increased pain, swelling, peri incision erythema and warmth. He underwent an aspiration which confirmed the infection. He underwent surgery (Hardware and debris were removed). He required Infectious Diseases (ID) consultation and appropriate antibiotics.  His condition stabilized with discharge to home. Information provided with the appeal reported history of previous prosthetic knee infections dating back several years. He had undergone right Total Knee Replacement (TKR) more than a decade prior and had undergone multiple revisions.  He underwent R TKR liner exchange several years ago and six weeks of antibiotics.  He underwent bilateral patella button revision. 

The medical records demonstrate the patient had long standing problems with infection to his right knee.  He had received appropriate treatment and additional reconstructive surgery was completed in early-2019. This was elective surgery. The procedure would only have been completed if no active infection was present.  Pre-operative testing would have been performed to assess evidence of underlying abnormality, i.e. elevated infection parameter and likely aspiration. 

There is no evidence to suggest this being a new event unrelated to operative intervention of early-2019. Based upon the definition of new event vs complication of surgery, the patient had a complication of his most recent procedure.  Services provided were a direct result of his prior operation.

The health care plan acted reasonably and with sound medical judgment and in the best interest of the patient. The patient developed signs and symptoms of infection.  It also may have been a re-activation of his previous condition.  This would be a direct result of the patella revision. Nevertheless, a post-surgical complication occurred.  He would be at increased risk secondary to significant pre-existing problems and comorbidity, at least 2-3 times greater than most people.

The carrier's denial of coverage for the inpatient hospital admission from is upheld.  The medical necessity is not substantiated.
Appeal type: Formulary Exception
Decision: Upheld

This is a patient with a family history of glaucoma in his mother. He has normal cup to disc ration of 0.2 per the chart and maximum intraocular pressure of 23, 20. No visual fields or optic coherence tomography is included. Per the notes, the patient has been treated with travatan z and possibly simbrinza though it is not clearly noted whether he is using the simbrinza only the travatan. His provider has put him on Rhopressa which was denied by his health plan; per the health plan, the patient must try and fail at least two formulary medications. At issue is whether the formulary drug will be or has been ineffective, would not be as effective as the non-formulary drug (Rhopressa 0.02% Ophth Solution), or would have adverse effects.

It is unclear why the patient is being placed on Rhopressa. There is no discussion of inadequate control of the intraocular pressure, nor is it clear from the notes that the patient had failed other medications or had an adverse reaction. Therefore, the formulary drugs cannot be considered ineffective compared to the nonformulary drugs. There is no mention of whether the formulary drugs have failed or why the patient needs a nonformulary medication in the information provided.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Glioblastoma multiforme
Treatment: Erivedge

The proposed treatment is not medically necessary.

The patient is a male with glioblastoma multiforme (GBM). Tumor mutation panel testing was positive for a PTCH1 mutation. On the basis of the presence of this mutation, request is for treatment with Erivedge (vismodegib).

The patient has glioblastoma multiforme (GBM). The gene PTCH1 encodes a protein that is critical in sonic hedgehog pathway signaling. The sonic hedgehog (SHH) pathway is one of the most complex signal transduction mechanisms that govern the precisely regulated developmental processes of multicellular organisms. Post-development, it also has an important role in post-embryonic tissue regeneration and repair processes (1, 2).

The data to support vismodegib to treat glioblastoma are all pre-clinical. Vismodegib has shown inhibitory activity on the growth of neurospheres in culture (3).

There are no published studies of vismodegib to treat GBM (www.pubmed.gov; searched 03/08/2020). 

This treatment is under study as one arm of the MATCH clinical trial:
NCT02465060: Molecular Analysis for Therapy Choice (MATCH) (4).

This treatment is not supported by the National Comprehensive Cancer Network (NCCN) Guidelines (5). 

As the efficacy of this treatment is unproven, it would not be considered medically necessary.

This was denied as the Standard Erivedge policy does not allow coverage of Erivedge unless the patient has a diagnosis of basal cell carcinoma. 

The denial as not meeting policy was correct. The denial was in the best interest of the patient as the requested treatment is unproven and the subject of ongoing clinical trials.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Gender dysphoria
Treatment: Mastectomy and Nipple Reconstruction (15200,15201,19303,19350)
The insurer denied the Mastectomy and Nipple Reconstruction (15200,15201,19303,19350).  
The denial is overturned.

The treatment, mastectomy and nipple reconstruction, is medically necessary. 

This is a transgender female to male (FtoM).  He transitioned almost five years ago.  He has been using a breast binder. His therapist supports mastectomy surgery. His surgeon plans mastectomies and nipple reconstructions.

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 mastectomy and creation of a male chest in FtoM 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 standard of care [SOC] for children and adolescents);
4. If significant medical or mental health concerns are present, they must be reasonably well controlled.
Hormone therapy is not a prerequisite.

Regarding chest surgery for adolescents, WPATH guidelines are as follows: "Chest surgery in FtoM patients could be carried out earlier, preferably after ample time of living in the desired gender role and after one year of testosterone treatment. The intent of this suggested sequence is to give adolescents sufficient opportunity to experience and socially adjust in a more masculine gender role, before undergoing irreversible surgery. However, different approaches may be more suitable, depending on an adolescent's specific clinical situation and goals for gender identity expression."

The patient meets these guidelines. He has well documented gender dysphoria and has the capacity to make an informed decision. He transitioned almost five years ago.  Mental health concerns are managed by his therapist.  His mental health professional and endocrinologist have recommended the mastectomies. The standard of care for adolescent top surgery is met.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Possible seizure
Treatment: Inpatient admission
The insurer denied the inpatient admission. 
The denial is upheld.

The inpatient admission was not medically necessary. 

The patient is a male with a history of alcohol use disorder who presented to the emergency ward after being found down. He eventually was awakened and was confused.  At presentation, he had a non-focal neurological examination. He was suspected of having a seizure and admitted for further management. He had an electroencephalography (EEG) which was abnormal, and he was started on anticonvulsant treatment. 

The patient was suspected of having an unwitnessed seizure but had returned to baseline by the time he presented to the emergency ward. He did not have any recurrent episodes. The diagnostic studies, monitoring and treatment could have been safely and effectively provided at a lower level of care.
Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Back pain
Issue under review: Methylprednisolone acetate

Determination:
The health plan denied methylprednisolone acetate. The health plan's denial is upheld.

The patient is an adult male with moderate to severe spinal stenosis who has undergone conservative treatment and was treated with lumbar epidural steroid injections (LESI) with good success, however short lived.  The patient underwent five LESIs within a 12 month period.

An ESI is a commonly used non-invasive treatment for symptomatic spinal stenosis and lumbar radiculopathy when a patient has failed conservative treatment. This is documented here.  

By most guidelines, and generally accepted standards, ESIs are limited to three per year.  The attending physician asserts that the injection under review was the third injection in the year.  While this is true, on review of the documentation, this is actually the fourth injection in a 12-month period, and in fact the fifth in a 13 month period.  So, while it is true this was the third injection in the calendar year, the patient has had one other injection in the last 12 month period, and another injection two weeks prior to that.   

Therefore, in the final third of the prior year, the patient received two ESIs, and in the first three-quarters of the next year, received three more.  The patient is basically getting an ESI every two to three months, which is generally not accepted standard of care.  While ESIs can be very helpful, the risks of continued steroid exposure are not to be ignored.  In addition, the general rule for three ESIs in a year is within a 12 month period, not a calendar year.  Given the above, the requested ESI is not medically appropriate.