Persius/hicric huggingface dataset:
Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Endometriosis.

Treatment NuvaRing.

The insurer denied coverage for NuvaRing.

The denial is upheld.

The patient is an adult female with a history of obesity and endometriosis. She has been on NuvaRing. She recently switched to generic NuvaRing and reported abnormal uterine bleeding for several months. The treating practitioner recommended starting brand NuvaRing 0.120 milligrams (mg)-0.15 mg/24 hour.  

Combined (estrogen-progestin) hormonal contraception is available as an oral pill, transdermal patch, or vaginal ring and is highly effective when used consistently and correctly. Commonly available combined hormonal contraceptive rings include the ENG/EE (etonogestrel/ethinyl estradiol) ring (ENG/EE, commercial name NuvaRing, EluRyng) and the segesterone acetate/ethinyl estradiol (SA/EE) ring (SA/EE, commercial name Annovera). The hormonal contraceptive vaginal rings offer the same benefits as the other estrogen-progestin combined methods but have the advantage that daily or weekly user compliance is not required.  

The ENG/EE, (commercial names NuvaRing, EluRyng) ring is a flexible device measuring 54 mm (millimeter) in diameter and 4 mm in cross-section that is worn vaginally for three weeks and then removed (and discarded) for one week. The outer ring is composed of both ethinyl estradiol (EE) and an ethylene vinyl acetate copolymer that contains crystals of ENG, the 3-keto-metabolite of desogestrel. The device releases an average of 120 mcg/day (microgram per day) of ENG and 15 mcg/day of EE over 21 days of use. The device is latex-free.

Generic medicines are copies of brand-name medicines. They are usually less expensive. Generic medicines have the same active ingredient as the brand-name medicine they copy.  Makers of generic medicines must follow the same government rules about strength, quality, and purity as makers of brand-name medicines. In the US (United States), the government requires careful testing of generic copies to make sure they will work as well as the brand medicines. As per Food and Drug Administration (FDA), generic medicines are as good as brand.

The formulary drug is not likely to cause the patient an adverse reaction. The generic ring contains the same ingredients as the brand product NuvaRing. The requested drug is not likely to be more effective than the formulary drug. It is the same size, contains the same ingredients, has the same side effects, safety and efficacy as the brand name and is approved by the FDA with the same indication and warnings.

The insurer's denial of coverage for Formulary Exception for NuvaRing is upheld.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Irritable Bowel Syndrome

Treatment Trulance 3mg (milligrams) tablet

The insurer denied coverage for Trulance 3mg tablet

The denial is upheld

The patient has a history of chronic constipation. She also complains about bloating. Supplemental fiber and MiraLAX have not worked. She has a diagnosis of irritable bowel syndrome and small intestinal bacteria overgrowth.

Up-To-Date article "Management of chronic constipation in adults" discusses pharmacologic therapy. Plecanatide has been approved by the FDA (Food and Drug Administration) for chronic idiopathic constipation. 20 percent of patients experienced improvement in the frequency of complete spontaneous bowel movements versus 13 percent in the placebo group. lubiprostone is also an FDA approved drug for constipation. Patients treated with lubiprostone had an increase in spontaneous bowel movements. Corresponding improvement was observed for abdominal bloating, discomfort, stool frequency and straining.

This patient has chronic constipation and requires pharmacologic therapy. The insurance company has offered lubiprostone as a formulary alternative. There are no head to head trials involving these agents. Zhang et al in a metanalysis of published trials involving 8 different drugs found that the increase in frequency of bowel movements was similar for lubiprostone and plecanatide.  In view of this, it is reasonable to first try the lubiprostone and if it is not successful, Trulance would be appropriate. Since lubiprostone has not been tried the request for Trulance is denied. 

The healthcare plan acted reasonably and with sound medical Judgement. Trulance is not medically necessary at this time. 

The insurer's denial of coverage for Trulance 3mg tablet once per day is upheld. Medical Necessity is not substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Psoriasis. 
Treatment: Taltz 80 milligrams (mg) every 2 weeks. 

The insurer denied coverage for Taltz 80 milligrams (mg) every 2 weeks. 
The denial is overturned. 

This case involves a patient who has been previously diagnosed with psoriatic arthritis as well as psoriasis, hypertension, arthritis, and acne vulgaris.  The documentation indicated she was seen for a follow-up.  The documentation indicated she had perimenopausal acne with nodules.  She was also being seen for a follow-up regarding psoriatic arthritis.  She has been utilizing Taltz since with good improvement.  She has no new lesions, and her joint pain has improved.  She has trialed topical medications with little help.  Physical examination revealed erythematous papules which were worse along the jawline of the face.  The physician indicated she should continue with Taltz. A letter of medical necessity indicates the patient has previously utilized this medication with benefit.  The physician indicated she has been suffering from breakthrough pain which does worsen in the morning.  Her peripheral joints remain stiff for approximately 15 minutes.  She feels good the first few days after Taltz; however, prior to her next injection her symptoms did return.  The physician indicated the efficacy of the medication is not lasting the entire month and therefore it was recommended they increase her dosing frequency to 80 mg every 2 weeks.  She has trialed Otezla as well as clobetasol, Lidex, triamcinolone, hydrocortisone. 

Taltz 80mg every 2 weeks is considered medically necessary for this patient. This is because Taltz 80 mg every 2 weeks is an approved dosing schedule for Taltz if the patient does not respond adequately to the every 4 week dosing. There have been recent trials which addressed the two weekly dosing schedule and the fact that some patients can continue with the two-week dosing interval in certain clinical scenarios after completing the loading dose. This particular patient would likely have a better outcome if she were to transition from the every 4 weekly to the every 2 weekly schedule since she has already responded favorably to this biologic. 

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 Taltz 80 milligrams (mg) every 2 weeks is overturned. Medical Necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohn's Disease. 
Treatment: Entyvio 300 mg every 6 weeks. 

The insurer denied the Entyvio 300 mg every 6 weeks. 
The denial is overturned. 

The patient is a female with moderate to severe Crohn's. She has failed 6-MP (mercaptopurine), steroids, Stelara, Humira, Remicade and Entyvio 300 mg (milligrams) every 8 weeks. Approximately three years ago, she lost response, and serum Entyvio levels were low at 11. Entyvio was increased to 300 mg (milligrams) every 6 weeks. She has been doing well at that time. Her provider is requesting continuation of Entyvio at 300 mg (milligrams) every 6 weeks. 

Yes, the Entyvio 300 mg (milligrams) every 6 weeks is medically necessary. 
Entyvio was denied by the health plan, as the dose of 300 mg (milligrams) every 6 weeks exceeds the plan-approved limit. 

Medical literature supports dose intensification of biologic agents in patients who lose response to FDA (United States Food and Drug Administration)-approved dosing. Entyvio has been found to be safe and effective at doses as high as 600 mg (milligrams) IV (intravenous) every 4 weeks. Per Singh et al, "shortening infusion interval from 8 to 4 weeks led to improved effect in 3/7 (43%). This is supported by recent pharmacokinetic data demonstrating significant correlation between higher vedolizumab drug levels and clinical response in inflammatory bowel disease (IBD) patients.'' 

During the trial completed by Williet et al, 30 out of 47 IBD (inflammatory bowel disease) patients undergoing induction with vedolizumab who had not achieved remission by week 6 of treatment had their dose frequency increased to every 4 weeks. All of those with vedolizumab through levels less than 10 mcg/mL(micrograms per milliliter) at week six achieved clinical remission 4 weeks after initiation of the higher dosing frequency. 

The patient in this case had not had a complete response to Entyvio 300 mg (milligrams) every 8 weeks, with persistent symptoms and low serum drug levels. She was increased to 300 mg (milligrams) every 6 weeks. Therefore, Entyvio 300 mg (milligrams) every 6 weeks is clinically appropriate, accepted standard of medical care, and is medically necessary.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Rheumatoid Arthritis. 
Treatment: Humira 40 milligram (mg). 

The insurer is denied coverage for Humira 40 milligram (mg). 

The denial is overturned. 

This female patient has a history of Rheumatoid Arthritis. 

Humira is Food and Drug Administration (FDA)-approved for the treatment of Rheumatoid Arthritis (RA) and Spondyloarthritis (SpA), with or without methotrexate. Humira is an appropriate choice for treating her RA. Her alcohol (ETOH) use, and child-bearing potential make methotrexate questionable. There are no clear reasons to choose one specific anti- tumor necrosis factor (TNF) over another, as they have similar benefits and efficacy. They can be given in pregnancy. The safety of Janus kinase (JAK)- kinase inhibitors such as Xeljanz with respect to pregnancy is not clear, and hyperlipidemia can be significant. There are concerns about vascular problems. They are not generally used as first-line therapy in biologic-naive patients. 

See www.uptodate.com chapters on "Initial Treatment of RA" and "Treatment of RA in adults resistant to initial non-biologic therapy". See also (2021 American College of Rheumatology [ACR] Guideline for the Treatment of RA). 

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

The carrier's denial of coverage for the Humira 40 milligram (mg)  is overturned.  The medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: a history of falls which have resulted in fractures.
Treatment: personal care aide (PCA) level 2 services of 12 hours per day, 7 days per week, 12 hours per day, 7 days per week (split shift) for a total of 168 hours per week.

The insurer is denied coverage for personal care aide (PCA) level 2 services of 12 hours per day, 7 days per week, 12 hours per day, 7 days per week (split shift) for a total of 168 hours per week.

The denial is overturned. 

This female patient has a history of heart failure, obesity, hypertension, diastolic dysfunction, hypothyroidism, osteopenia, asthma, lymphedema, glaucoma, visual impairment, gait instability, osteoarthritis and a history of falls which have resulted in fractures.

The patient was previously approved personal care aide for 14 hours/day at 6 days/week and 13 hours/day for 1 day/week. It was reported that the patient had required 24 hours/day, but her family was willing to provide informal support for the remaining hours each day.  However, at this time the patient's condition had worsened and her family was no longer capable of providing appropriate care. The patient has a history of falls secondary to weakness. The patient fell and hit her head which required hospitalization due to traumatic intracranial hemorrhage with subdural hematoma.  The patient was also hospitalized for mental status changes secondary to metabolic derangement and hypokalemia.  The patient's condition has progressed, and family member are no longer able to provide care overnight. The patient lives alone and requires assistance overnight. As such, the request for Personal Care Aide (PCA) Level 2 Services of 12 hours per day, 7 days per week, 12 hours per day, 7 days per week (split shift) for a total of 168 hours per week is medically necessary. 

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

The carrier's denial of coverage for the personal care aide (PCA) level 2 services of 12 hours per day, 7 days per week, 12 hours per day, 7 days per week (split shift) for a total of 168 hours per week is overturned.  The medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Multiple Sclerosis
Treatment: Copaxone 40mg/ml SC SOSY, Pre-service
The insurer denied the Copaxone 40mg/ml SC SOSY, Pre-service
The denial is upheld. 

The patient is a female with multiple sclerosis (MS). She has been treated with natalizumab but this was discontinued due to anticipated pregnancy. The provider is requesting brand Copaxone. This was denied coverage as the patient has not tried the preferred generic equivalent medication, glatiramer.

No, the proposed treatment is not medically necessary.
There is no reason the patient cannot be treated with the preferred formulary agent. Glatiramer is the generic equivalent of the requested medication and clinical trials have demonstrated that it is as efficacious as the brand Copaxone (Selmaj et al.). Moreover, there is no data to suggest that using the generic bioequivalent medication would be less safe then using the requested medication during pregnancy (Langer-Gould).  There are no high quality clinical trials or standard of care guidelines supporting the preferential use or superiority of brand Copaxone relative to the preferred generic equivalent in this clinical context.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Anterior open bite
Treatment: D8080 (Braces), D8670 (Monthly Visit) x 12
The insurer denied the D8080 (Braces), D8670 (Monthly Visit) x 12
The denial is overturned. 

The patient is a male requesting orthodontic treatment and follow-up appointments. He has an anterior open bite.

Yes, the proposed D8080 (Braces) and D8670 (Monthly Visit) x 12 are medically necessary.
The patient has an anterior open bite. This means that his front upper and lower teeth do not touch. Upon moving his lower jaw forwards, during the chewing cycle, his back teeth will grind into each other and over time cause excessive wear and/or fracturing of his back teeth. Normally, the lower front teeth glide along the back of the upper front teeth and allow for "disarticulation", or a controlled opening of the whole dentition. This controlled disarticulation will allow the back teeth to separate from each other and prevent any trauma. With an anterior open bite, this cannot happen and the patient's teeth will bang into each other traumatically. Orthodontic treatment is medically necessary to correct this problem and the follow-up appointments are needed to assess the progress of the treatment.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohn's colitis

Treatment: Stelara 90 milligrams (mg)

The insurer is denied coverage for Stelara 90 milligrams (mg)

The denial is overturned. 

This male patient has a history of Crohn's colitis

An article titled "Effectiveness of ustakinumab dose escalation in patients with Crohn's disease" concluded that shortening the ustakinumab dose interval to four weeks in patients with Crohn's disease who did not respond to doses every eight weeks improved clinical and biologic indices of disease activity. Patients who lose response to the standard dose of ustakinumab might benefit from dose interval shortening which was noted to be effective and safe. The medical literature supports the use of Stelara at four week intervals. It is medically necessary treatment.

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

The carrier's denial of coverage for the Stelara 90 milligrams (mg) is overturned.  The medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Increased Overjet

Treatment D8080 braces

The insurer denied coverage for D8080 braces.

The denial is overturned.

The patient has 3 impacted canines which is an automatic qualifier. The treatment meets the guidelines as there are impacted canines and this is the standard of care. Per An Introduction to Orthodontics, one or more of these dental traits that would have an adverse effect on the longevity of dentition, indicating high need for correction: 

1)	Increased Overjet
2)	Increased traumatic Overbites
3)	Anterior crossbites causing decreased periodontal support
4)	Unerupted impacted teeth (where there is danger of pathology)
5)	Crossbites associated with mandibular displacements.

Per the clinical records, the patient does meet the requirements. The patient has three on a ruptured canines which are impacted against the adjacent teeth and there is the possibility of these causing resorption of these teeth. Orthodontic treatment is medically 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 D8080 braces is overturned. Medical necessity is substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Skeletal Class I; normal vertical growth pattern; permanent dentition

Treatment: insertion of braces (comprehensive orthodontic treatment of the adolescent dentition)

The insurer denied coverage for insertion of braces (comprehensive orthodontic treatment of the adolescent dentition)	

The denial is upheld.

This is the case of a female patient that was evaluated for orthodontic treatment. A clinical examination and analysis consisting of a dental and jaw evaluation revealed the following findings: Skeletal Class I; normal vertical growth pattern; permanent dentition; Class II canines; mild maxillary crowding; mild mandibular crowding; slightly excessive overjet; several teeth have missing crowns or lesions; deep impinging overbite with severe soft tissue damage. The following automatic qualifier was chosen on the patient's Handicapping Labio-Lingual Deviation (HLD) Index report documented: deep impinging overbite with severe soft tissue damage. The dental director states that the HLD is 7. The provider states that the patient automatically qualifies as there is a deep bite. 

Per An Introduction to Orthodontics, one or more of these dental traits that would have an adverse effect on the longevity of dentition, indicating high need for correction:

1)	Increased Overjet
2)	Increased traumatic overbites
3)	Anterior crossbites causing decreased periodontal support
4)	Unerupted impacted teeth (where there is danger of pathology)
5)	Crossbites associated with mandibular displacements.

Per the clinical records, the patient does not meet the above requirements. To qualify with a deep bite, there must be documentation that the lower incisors are destroying the soft tissue of the palate. There is not an increased overjet traumatic overbite, anterior crossbite, impacted teeth or crossbites associated with mandibular displacements. Therefore, braces are not considered medically necessary treatment for the patient's condition.

The health care plan did act reasonably, with sound clinical judgment, and in the best interest of the patient.

The insurer's denial of coverage for the insertion of braces (comprehensive orthodontic treatment of the adolescent dentition) is upheld. Medical necessity is not substantiated.
Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Dyshidrotic Eczema.
Treatment Dupixent Syn (syringe) 300.
The insurer denied coverage for Dupixent Syn 300.
The denial is upheld.

This is the case of an adult male patient with a medical history of eczema. He presented for an evaluation of dyshidrotic eczema and his dermatologist has requested coverage for Dupixent Syn 300 for this patient. 

According to the American Academy of Dermatology Atopic Dermatitis Clinical Guidelines and dermatology literature, the conventional medications such as topical steroids, protopic, elidel, and methotrexate are effective treatments for the management of atopic dermatitis and related eczematous disorders. (1,2)

Within the peer-reviewed literature, Gerbens et al writes "Methotrexate (MTX) and azathioprine (AZA) seem to be effective and safe as maintenance treatments in moderate to severe atopic dermatitis (AD) up to a few years." (3) Shah et al writes "Methotrexate is an effective treatment for moderate to severe atopic dermatitis with an acceptable safety profile. A low dose can be used to control the disease for prolonged periods without significant risk." (4) There are several published studies that show that methotrexate is effective and safe for moderate-severe atopic dermatitis. (5-8)

There is no medical and scientific literature and/or evidence based clinical practice guidelines that strongly support the administration of Dupixent for this patient's condition as an accepted standard of practice in the U.S. (united states) compared to alternative therapies.  

The conventional medications, such as methotrexate, should be tried and failed prior to initiating Dupixent. Therefore, Dupixent is not medically necessary for this patient according to the standard of care.

The requested medication Dupixent is not medically necessary based on the standard of care, and there are no unique clinical circumstances to this particular individual in the documentation provided that would make it medically necessary. It is noted that the patient has a diagnosis of dyshidrotic eczema and has failed therapy only with topical steroids. However, the patient has no true contraindications to the conventional medications commonly used for atopic dermatitis.  

The health plan did act reasonably with sound medical judgment, and in the best interest of the patient.

The insurer's denial of coverage for Dupixent Syn 300 is upheld. Medical necessity is not substantiated.