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

Diagnosis: Psoriasis Vulgaris

Treatment Skyrizi

The insurer denied coverage for Skyrizi

The denial is upheld

The patient is an adult female with a diagnosis of psoriasis vulgaris. She has failed topical therapies. There is no documentation provided that the patient has tried systemic therapies. The requested medication is Skyrizi. Laboratory data to demonstrate possible contraindications to alternative therapies was not provided. IPRO requested labs but they were not provided. 

According to the American Academy of Dermatology Psoriasis Guidelines and dermatology literature, alternative effective treatments for the management of psoriasis are available and appropriate for this patient (1,2,6). Within the peer-reviewed literature, Racz et al writes "Phototherapy is a standard treatment option for psoriasis, generally applied if topical treatment modalities fail or are contraindicated...Phototherapy may lead to the clearance of psoriasis in 5 to 8 weeks" (3). Mehta et al writes "Ultraviolet (UV) B phototherapy is most appropriate for patients with >10 % (percent) affected body surface area who have not responded to topical treatments... narrowband ultraviolet B (NB-UVB) effective treatment options for psoriasis...Long-term data on NB-UVB indicate that it has a good safety profile." (4)

Additionally, West et al conducted a review of eleven comparative, controlled studies that passed a Cochrane risk of bias analysis (5). They concluded that methotrexate achieved significant improvement in reducing psoriasis plaques. Methotrexate is a preferred treatment, and based on data analysis, 45.2% [95% confidence interval 34.160.0] of patients achieve psoriasis area and severity index (PASI 75) at primary endpoint, Thus, methotrexate is an effective first-line treatment for the management of psoriasis (5).

Based on the documentation provided, Skyrizi is not considered medically necessary. Skyrizi is not medically necessary for the patient's condition, psoriasis vulgaris. There is no medical and scientific literature and/or evidence based clinical practice guidelines that strongly support the administration of Skyrizi for this patient's condition above reasonable alternatives as an accepted standard of practice in the US ( United States). 

There are no comparative, controlled head-to-head studies showing that Skyrizi has a superior efficacy or safety profile to alternatives such as Humira, phototherapy, or methotrexate.  

Based on the medical documentation provided, Skyrizi is not considered medically necessary.

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

The insurer's denial of coverage for Skyrizi is upheld. Medical necessity is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Cognitive impairment, coronary artery disease, congestive heart failure, chronic kidney disease - stage V, hypertension, diabetes mellitus, gait ataxia and frequent falls. 

Treatment: Personal Care Services 24 hours per day, seven days per week (split shift), 168 hours total. 

The insurer denied the request for Personal Care Services 24 hours per day, seven days per week (split shift), 168 hours total. 

The denial is overturned. 

The patient is an senior male with a history of cognitive impairment, coronary artery disease, congestive heart failure, chronic kidney disease - stage V, hypertension, diabetes mellitus, gait ataxia and frequent falls. Due to impairments related to these conditions, he requires assistance for completion of the majority of his activities of daily living (ADLs). 

An appeal review was requested for Personal Care Services 24 hours per day, seven days per week (split shift), 168 hours total to provide increased support for the patient's activities of daily living (ADL). 

Yes, the requested Personal Care Services 24 hours per day, seven days per week (split shift), 168 hours is medically necessary. 

This is a senior male with a history of cognitive impairment, coronary artery disease, congestive heart failure (CHF), chronic kidney disease - stage V, hypertension, diabetes mellitus, gait ataxia and frequent falls.  Although an assessment of the patient's functionality and ability to perform activities of daily living (ADLs) was completed and revealed that the currently approved plan of 49 hours per week personal assistance services is sufficient to meet the patient's current needs, the patient's daughter relates this reduced schedule leaves the patient home alone, completely unassisted for numerous hours per day.  However, this is problematic due to the patient's worsening cognitive and functional status.  At current time, the patient requires more assistance with bathing, toileting, ambulation, personal hygiene, meal preparation, housekeeping, laundry, dressing and grocery shopping.  The patient's increased needs for activities of daily living (ADL) assistance are not met by the current schedule of 49 hours per week personal assistance services. 

As such, the provision of Personal Care Services 24 hours per day, seven days per week (split shift), 168 hours can reasonably be expected to be beneficial for the patient and withholding these services, in whole or in part, can reasonably be expected to affect the patient's health adversely.  For these reasons, the requested Personal Care Services 24 hours per day, seven days per week (split shift), 168 hours is deemed medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Scoliosis with resultant lumbar radiculopathy.
Treatment an injection in-between the bones in the lower back (procedure code 64493 and 64494).
The insurer denied coverage for an injection in-between the bones in the lower back (procedure code 64493 and 64494).
The denial is overturned.

This patient has chronic low back pain due to scoliosis with resultant lumbar radiculopathy and facet pain. She has tried Physical Therapy, non-steroidal anti-inflammatory drugs (NSAIDs) and Muscle relaxants. She had an Epidural steroid injection which ameliorated her lumbar radiculopathy. She had plain x-rays of the entire spine, frontal and lateral.  The request is for diagnostic medial branch blocks at 2 levels, L (lumbar) 4-L5 and L5-S (sacral) 1.

Cohen et al. (1) conducted a multi-specialty society review to achieve consensus on clinical practice guidelines on facet interventions.

"We recommend a 3-month trial of different conservative treatments before facet joint interventions. Conservative therapies may include medications (eg, non-steroidal anti-inflammatory drugs, antidepressants), physical treatments (exercise, heat or cold therapy, massage), integrative treatments (acupuncture, spinal manipulation if indicated) and others (nutrition, weight loss, sleep hygiene) ...here is no existing evidence that demonstrates the appropriate timing or optimal duration of conservative treatments for chronic low back pai (LBP)."  It is 81 days since her first telemedicine visit, so she will have met the 3-month requirement of conservative therapy failure.

The Health Plan seems to require advanced imaging. However, the patient has had plain x rays of the entire spine which provide a diagnosis. The concept that a computed tomography (CT) or magnetic resonance imaging (MRI) is required, is not evidence based. Manchikanti et al. (2) in evidence based clinical guidelines state: 

"The level of evidence is V [5] with weak strength of recommendation for scintography,
magnetic resonance imaging (MRI), and computed tomography (CT)."

In 9 days, the patient will have met the conservative therapy recommendation. At that time, the intervention will be medically reasonable and necessary. 

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 an injection in-between the bones in the lower back (procedure code 64493 and 64494) to be provided is overturned. Medical Necessity is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Head/Neck Cancer.
Treatment: Proton Beam Radiation Therapy, Pre-service.
The insurer denied the Proton Beam Radiation Therapy, Pre-service.
The denial is upheld. 

This patient is a woman with a stage T3N2cM0 (stage 3 tumor, Cancer in lymph node - Stage 2, no distant metastases) squamous cell carcinoma of the oropharynx.  Radiation therapy is recommended as definitive treatment, and proton beam approach is requested.

No, the Proton Beam Radiation Therapy is not medically necessary.
The requested proton beam radiation therapy is not considered medically necessary. This approach of treatment is not considered a standard treatment approach for this diagnosis. The use of proton beam radiation has not been proven to be as effective as, or better than, conventional treatment with photon beam radiation from randomized clinical trials.

There is a lack of any significant studies published in peer-reviewed journals supporting the use of proton beam radiation therapy for oropharynx cancers.  There are multiple ongoing clinical trials, and until they mature and publish in peer-reviewed journals, this would be considered not medically necessary.  The small studies published in medical literature state the need for additional trials to be completed to determine the benefits and safety of proton beam radiation therapy for this patient's clinical scenario.
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Sexual dysfunction, vaginal atrophy, uterine prolapse

Treatment Estring

The insurer denied coverage for Estring

The denial is overturned

The patient is a female with a past history of sexual dysfunction, vaginal atrophy, uterine prolapse, chronic interstitial cystitis status post hysterectomy, and bilateral salpingo-oophorectomy. The provider noted that the patient had tried and failed Estrace cream and estradiol cream which produced burning, pruritus, and rash. The Femring gave an inadequate response. The patient had a trial and failure of a generic agent. The provider requested Estring 2 milligram (mg). 

The provider appeal letter noted that the patient had been using the medication for years and it was effective.

The patient has had an adverse reaction to previously tried formulations, Estradiol cream, and brand Estrace cream.

The patient has tried and failed Estradiol cream, and brand Estrace cream due to side effects as well as Femring which was ineffective.

The requested Estring has been shown to be more effective than the previously 3 tried and failed medications. The patient has successfully used Estring for years, with noted efficacy and without adverse effects.

The insurer's denial of coverage for Formulary Exception for Estring is reversed.
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Multiple Sclerosis (MS)

Treatment Vumerity 231 mg (milligrams) delayed release capsule

The insurer denied coverage for Vumerity 231 mg delayed release capsule

The denial is upheld

This case involves a male patient who has a diagnosis of multiple sclerosis (MS). The documentation indicated the patient has relapsing remitting MS and has had a trial of Tecfidera and its generic in the past. The documentation indicated the patient should not have to trial and fail multiple formulary medications as this will put him at high risk of progression. The documentation indicated he was seen for a follow-up regarding MS. He was noted to be in the process of changing therapies to the requested medication as the other options he had tried were cost prohibitive. The documentation indicated he utilized Tecfidera with his last dose being. The documentation indicated there was no significant findings on physical examination as he had 5/5 strength throughout. Coordination was intact and he had a steady gait. The physician indicated the patient has been maintained on Tecfidera with 100% compliance. However, as noted above they are cost prohibitive. It was recommended he switch to the requested Vumerity.

This patient's formulary benefits require that the patient must have tried and failed multiple meds - dimethyl fumarate (DMF), Avonex, Copaxone, Gilenya, Mayzent, Plegridy, and Rebif. This patient tried Tecfidera and DMF - no documentation of drug failure or side effects. DMF, Tecfidera, and Vumerity are all metabolized to the same active ingredient - monomethyl fumarate (MMF). Hence, if someone fails DMF or Tecfidera, then Vumerity should not be the next medication as it is in essence the same medication as DMF or Tecfidera. Therefore, given the above, the prior determination is upheld. 

The insurer's denial of Formulary Exception for Vumerity 231 milligrams (mg) delayed release capsule to treat multiple remitting multiple sclerosis is upheld.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Ulcerative Colitis.
Treatment: Stelara SQ 45MG Every 4 Weeks.
The insurer denied the Stelara SQ 45MG Every 4 Weeks.
The denial is upheld. 

This is a male with ulcerative colitis who has previously used Entyvio, Remicade, Xeljanz. The patient is on Stelara with response. The patient continues to have mucus per rectum up to 6-7 times per day, rare blood, and rare incontinence of blood / mucus.  The fecal calprotectin has improved from 2000 to 200.

The request is for Stelara 45 mg administered every 4 weeks - standard dosing is Stelara 90 mg every 8 weeks.

No, the proposed treatment is not "medically necessary".
Literature supports dose escalation of Stelara to 90 mg every 4 to 6 weeks.

Literature is as follows:
At the American College of Gastroenterology (ACG) Scientific Meeting, results from the induction phase of the Phase III UNIFI study show that treatment with a single IV (intravenous) dose of Stelara induced clinical remission in a significantly greater proportion of UC (ulcerative colitis ) patients at week 8, compared with placebo, at both doses studied. 15.6% of patients receiving 130 mg ustekinumab and 15.5% of patients receiving ~6 mg/kg ustekinumab achieved clinical remission, compared with 5.3% of patients receiving placebo. Remission was defined as a Mayo score 2 points, with no individual subscore >1 Major secondary endpoints including the proportion of patients in clinical response, endoscopic healing, as well as improvement in health-related quality of life, were also significantly higher at week 8 among patients receiving Stelara compared with patients receiving placebo. About 50% of study participants are considered biologic refractory, and 17% have a history of inadequate response or intolerance to an anti-TNF (tumor necrosis factor) and/or Entyvio (vedolizumab) (article was later published in the NEJM - Sands BE et al. N Engl J Med.) 

Dose escalation of Stelara may be required in some patients. In a retrospective multicenter cohort study was performed on patients with CD (Chron's disease), dose escalation was required in 17 patients (16.3%); response was recaptured in 9/17 (52.9%) (Ma C et al, Inflammatory Bowel Disease). In another multicenter open-label study, dose escalation was effective in 8 of 11 (73%) patients (Khorrami S et al. Inflamm Bowel Dis.).  In a single center retrospective open-label observational study, dose escalation was required in 47.7% of the patients and was successful in 61.1% of them (Kapylov et al.  J Crohns Colitis.).

However, literature does not support the efficacy of Stelara at a lower dose at 45 mg every 4 weeks for a diagnosis of ulcerative colitis.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: General debility, bilateral knee osteoarthritis
Treatment: Extended Stay in Skilled Nursing Facility
The insurer denied the extended stay in skilled nursing facility.
The denial is upheld.

The member is a male with history of general debility, bilateral knee osteoarthritis, hypotensive episodes and frequent falls.  Relevant past medical history includes polyneuropathy.  The patient was admitted to Skilled Nursing Facility (SNF).  Prior to admission, he was living with his family and required moderate assistance for all activities of daily living (ADLs), using wheelchair due to uncontrolled knee pain and frequent falls.

There was no tangible improvement in rehabilitation with further evidence that between the last eight days of admission, there was no change in level of activities which were lack of ambulation, totally dependent on toilet transfer, requiring maximum assistance for lower body dressings/bathing, toileting, moderate assistance for transfers, minimum assistance for bed mobility, upper body dressing/bath, and contact guard for grooming/feeding.

No, the proposed treatment is not medically necessary.

The proposed continued skilled nursing facility care is not medically necessary and should not be covered by the health plan for the period forward because the patient has not met all the criteria for sub-acute rehabilitation care under INTERQUAL Skilled Nursing Facility (SNF) Criteria.  The patient was admitted to sub-acute nursing facility (SNF) and there was no tangible improvement in rehabilitation with further evidence that during the last eight days of admission there was no change in level of activities which were lack of ambulation, totally dependent on toilet transfer, requiring maximum assistance for lower body dressings/bathing, toileting, moderate assistance for transfers, minimum assistance for bed mobility, upper body dressing/bath, contact guard for grooming/feeding.

Further rehab goals can be met at a lower level of care as his prior level of activities before admission required moderate assistance for all activities of daily living (ADLs), using wheelchair due to uncontrolled knee pain and frequent falls.

Therefore, the plan has appropriately denied coverage and the patient will be better served in a lower level of care.

The health plan acted reasonably in this instance and its decision was with sound medical judgment, which was in the best interest of the patient.  As stated above, the continued stay in skilled nursing facility was not medically necessary with clinical evidence showing no change in rehabilitation and is not reasonably expected to be health beneficial for the patient and/or withholding it in whole or in part be reasonably expected to affect the patient's health adversely as he has not shown tangible change in rehabilitation with most activities of daily living (ADLs).
Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Hidradenitis Suppurativa.	
Treatment: Siliq.
The insurer denied coverage for Siliq.
The denial is overturned.

The patient is an adult female with a diagnosis of hidradenitis suppurativa (HS) who has failed therapy with oral antibiotics, topical antibiotics, and Humira. The patient recently was evaluated for a flare in the Emergency Department. The requested medication is Siliq.  
 
The patient has failed Humira, which is Food and Drug Administration (FDA) approved for the treatment of HS. In addition, the patient has failed oral and topical antibiotics known to treat HS. Case reports have demonstrated possible efficacy of Siliq for the treatment of HS. Siliq is vital for the patient's condition, HS.

Kashetsky et al found that of 22 patients, all responded to brodalumab within 4.4 weeks. Similarly, Frew et al studied 10 patients with HS and all showed improvement on the Hidradenitis Suppurativa Clinical Response (HiSCR), Sartorius, and International Hidradenitis Suppurativa Severity Scoring System (IHS4) scores. The standard of care for failure of medications known to treat HS has been met based on the reported history. Furthermore, there are studies supporting its efficacy. As such, the use of alternative treatment strategy in the form of Siliq is supported.  

The insurer's denial of coverage for Formulary Exception for the medication Siliq for the treatment of Hidradenitis Suppurativa is overturned.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Cerebral vascular accident (CVA) with hemiplegia, seizures, and depression

Treatment continued Long Term Custodial Care Services

The insurer denied coverage for continued Long Term Custodial Care Services

The denial is overturned

The patient has multiple medical problems including cerebral vascular accident (CVA) with hemiplegia, seizures, and depression.  She was admitted to a care Center.  Several attempts at placement have been made by the social worker to an assisted living facility.  Under review is the medical necessity of continued long term custodial care services.

The insurer indicated long term custodial care should be discontinued since the patient is able to transfer in and out of bed and toilet using an assistive device.  However, she continues to require significant assistance.  The generally accepted clinical criteria indicate patients require either hands-on assistance with activities of daily living (ADLs)/mobility or have cognitive deficits requiring supervision/cueing for ADLs.  The patient continues to meet criteria for long term custodial care.  The more recent physical therapy evaluation indicates the patient requires moderate assistance for transfer activities and for ambulating (20 feet) with a wide based quad cane.  According to the occupational therapist, she requires moderate assistance for ADL tasks such as bathing, toileting, and dressing.   

The healthcare plan did not act reasonably, with sound medical judgment or in the best interest of the patient, continued long term custodial care services forward is medically necessary.

The insurer's denial of coverage for continued Long Term Custodial Care Services forward is overturned. Medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Root canal treatment (RCT)

Treatment D2750 white glass with high gold content crown, Tooth 3

The insurer denied coverage for D2750 white glass with high gold content crown, Tooth 3

The denial is overturned

Based on the submitted documentation which includes copies of periapical radiograph, narrative letter from the dentist and insurer correspondence, it appears that this patient presented for dental care.  A failing long standing stainless-steel crown restoration, was noted on #3 which had successful endodontic therapy years prior.  Currently the dentist is requesting replacement of the crown due to wear. The insurer has denied the full coverage crown stating that the service is not medically necessary as the documentation did not demonstrate medical need to support the treatment, such as caries or a missing crown and therefore the circumstance does not fulfill stated criteria for approval. The patient is appealing the decision.

Upon review of radiograph, it supports the recommended treatment. Tooth #3 exhibits a stainless-steel crown with open margins on both the mesial and distal aspects of the tooth consistent with a failing existing restoration.  There is ample coronal structure remaining.  This tooth will have adequate residual coronal structure for support of a crown and adequate residual periodontal alveolar bone height.  The standard of care in general dental practice would be replacement crown on an endodontically treated to which would have an excellent long-term prognosis with the recommended treatment.

D2750 white glass with high gold content crown, tooth #3 is medically necessary as the radiographic documentation supports this service, and this service would be a standard of care in general dental practice.

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 D2750 white glass with high gold content crown, Tooth 3 is overturned. Medical necessity is substantiated.