Persius/imr-appeals huggingface dataset:
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary:  An enrollee has requested reimbursement for inpatient acute rehabilitation services at Childrens Specialized Hospital from 7/23/21 through 8/11/21.The submitted documentation supports the medical necessity of the services at issue. Mayer and colleagues conclude, An interdisciplinary team can best decide the appropriate level of rehabilitation care after an acute hospitalization. The authors also state, It requires interdisciplinary input and involvement of all stakeholders. The decision should be informed by outcomes data specific to the patients diagnosis, impairments, and psychosocial supports. In this case, the patient sustained severe trauma due to a motor vehicle accident, resulting in severe injuries to both lower limbs. The patient underwent extensive surgical care to the lower limbs and had significant restrictions on her lower limb weightbearing in order for these injuries to heal. Nevertheless, the patient had functional deficits and appropriate rehabilitation goals despite these restrictions. In particular, she needed to maximize her bed mobility, slide board transfers, popover transfers, and self-care without being able to stand. There had been a substantial change in the patients health and function in comparison to her baseline and multidisciplinary rehabilitation to address potential effects on her long-term health and function. The patient participated in intensive therapies and made gradual, but clinically meaningful, functional progress during the time period under review. There were intensive rehabilitation needs, need for close supervision/management/rehabilitation oversight, and need for 24-hour per day rehabilitation nursing availability during this time period, which supports the medical necessity of acute inpatient rehabilitation level services. Therefore, inpatient acute rehabilitation services at Childrens Specialized Hospital from 7/23/21 through 8/11/21 were medically necessary for treatment of the patients medical condition.Final Result: The reviewer determined that the services at issue were medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer is board certified in physical medicine and rehabilitation and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Duexis. The current medical literature and guidelines regarding treatment with NSAIDs in patients at high risk for gastrointestinal toxicity recommend co-therapy with misoprostol, histamine type-2 receptor antagonists or proton-pump inhibitors (PPIs) and/or cyclooxygenase-2 (COX-2) selective inhibitors. The records provided for review document that this patient has chronic wrist pain due to degenerative joint disease. The patient has been treated with steroid injections and NSAID therapy including ibuprofen, acetaminophen, and Naproxen, but these were stopped due to gastritis. However, there is a lack of documentation that the patient was concurrently treated with stomach protecting agents with use of NSAIDs. The current data supports use of a selective COX-2 inhibitor anti-inflammatory agent in combination with a proton pump inhibitor or a type two histamine blocking medication to reduce the risk of gastrointestinal side effects. The medical literature has not demonstrated that Duexis is superior to treatment with ibuprofen 800 mg with famotidine 80 mg in combination as single agents. All told, the requested Duexis (ibuprofen and famotidine) tablets 800 mg/26.6 mg are not medically necessary for treatment of this patient. Final Result: The reviewer determined that the requested medication is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: The reviewer is board certified in anesthesiology with subspecialty certification in pain management and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned

This patient is a 44-year-old woman, gravida 3, para 2, with secondary infertility. Her last pregnancy resulted in a spontaneous loss in the spring of 2004, and she and her partner have apparently had unprotected intercourse since that time without conceiving. The patient has regular menstrual cycles, which is consistent with normal ovulation, and there is nothing in her history to suggest ovulatory dysfunction per se. Her evaluation to date includes a battery of hormonal studies obtained in May 2006, presumably on day two or three of her menstrual cycle. All of these studies were normal, including relatively reassuring FSH (7.3) and estradiol values (29.2). In addition, a hysterosalpingogram was normal in May 2006. The patient also underwent formal genetic counseling in March 2006, at which point the impact of her age on fetal chromosomal abnormalities was reviewed along with other topics. Based upon the record, it does not appear that semen analysis has been obtained.The patients request for treatment to address her infertility was denied by the Health Plan based upon a determination that the therapy is not medically necessary.I would consider the patients infertility to be unexplained aside from her age, assuming her partners semen analysis is relatively normal. Injectable fertility drugs combined with intrauterine inseminations (IUI) can be used successfully to treat women with unexplained infertility, increasing the chances of pregnancy each month by a factor of two or three. In this situation about half the benefit derives from the drugs and about half from the IUI. The patients baseline chances of conceiving a viable pregnancy any one month are almost certainly less than 1%, because of her age. Thus the expected benefit for her from such treatment would be very low. For example, her chances of conceiving a viable pregnancy might rise from 0.3 or 0.5% to 1% or 1.5%. In contrast, her chances of a live birth following donor oocyte invitro fertilization (IVF) treatment, as recommended by the Plan providers, would probably be 50% or higher. I have assumed the patient does not have coverage for this alternative.The portion of the Evidence of Coverage submitted by the Health Plan includes a description of covered infertility services. There is no explicit age cutoff given for the female partner. As such, if her partner has a reasonably normal semen analysis, then I believe there is no basis for the denial, despite the very low chances for success. With normal day two/three FSH and estradiol levels, a total of three combined gonadotropin/IUI treatment cycles would be reasonable. Such treatment would be medically necessary from the standpoint of increasing her chances of pregnancy above what they would be without treatment. Based upon the information set forth above, I have determined the requested therapy is medically necessary for treatment of the patients medical condition pending the partners sperm analysis. The Health Plans denial should be overturned.
Appeal type: Experimental/Investigational
Decision: Upheld

A 39-year-old male enrollee has requested a low dose chemotherapy for the treatment of his Hodgkins lymphoma, stage 4. Findings:  Three physician reviewers found that Hodgkins lymphoma is one of the most curable human cancers, and many years of intensive studies have provided the scientific and clinical evidence for the current therapies.  Deviation from the current state of the art recommendations is not within the standard of care. It is well established by multiple clinical studies that deviation from the current state of the art to treat Hodgkins lymphoma is in fact detrimental and clearly not more beneficial.
Appeal type: Experimental/Investigational
Decision: Upheld

A 50-year-old male enrollee has requested for robotic-assisted colon surgery for treatment of his colon cancer.   Findings:  Two physician reviewers found that the Clinical Outcomes of Surgical Therapy Study Group (COST) study demonstrated the equivalency of open and laparoscopic surgery in the treatment of colon cancer. There may be short-term benefits to laparoscopic surgery (less blood loss, shorter hospitalization, less pain) and the technique does not compromise oncologic outcomes. Robotic-assisted surgery is a further technologic modification of traditional laparoscopic surgery, though whether the use of a robot further improves (or compromises) outcomes is unclear. It is unlikely that a trial will be performed comparing robotic-assisted colon surgery to traditional laparoscopic surgery, and therefore case series with historical (or concurrent) series comparison will be the only evidence to support this technique. While the early reports demonstrate acceptable and comparable outcomes to laparoscopic surgery, there are currently few data of this type. All told, there is insufficient evidence available to date that robotic-assisted surgery is more beneficial to the patient than options such as traditional laparoscopic colectomy or an open colectomy.
Appeal type: Experimental/Investigational
Decision: Upheld

A 53-year-old male enrollee has requested a circulating cold pad/pump for treatment of his status post shoulder surgery.  Findings:  Three physician reviewers found that Konrath and colleagues performed a randomized prospective study of postoperative use of cold therapy following anterior cruciate ligament reconstruction. Patients were randomized into four groups after the surgery. Group 1 was prescribed a cooling pad applied to the knee, and this was set at 40 to 50F. Group 2 had a cooling pad set at 70 to 80F.  Group 3 received ice packs. Group 4 received no cold therapy of any kind. These authors found that there were no objective benefits in the early postoperative course and no significant differences between the groups of patients studied.  In the article by Daniel and colleagues, 131 patients were followed after arthroscopically-assisted anterior cruciate ligament reconstruction. These patients were randomized into five treatment groups. These groups were cooling pads at 40, 45, 55 and 70, or no cooling pads. In the study of these patients, there were no differences between groups referencing hospital stay, pain medication use, pain scale, knee girth or range of motion.  Overall, the medical literature does not support the increased efficacy of an active cooling system over the use of cold by standard cooling pads and ice packs in the management of postoperative pain.  Thus, the circulating cold pad/pump was not likely to have been more efficacious than other treatment options in this patients case.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Synvisc-One injection in both knees. Findings: Per the medical literature, although viscosupplementation may relieve knee pain in some individuals with osteoarthritis, it is not known as to which individuals will benefit. The current evidence is limited, and guidelines from organizations such as the American Academy of Orthopedic Surgeons indicate that the evidence is not conclusive. In light of the foregoing, viscosupplementation can only be recommended in individuals with a history of lasting benefit from prior injections, and in carefully selected cases where everything else has been tried, and the options are limited. In this case, the patient has tried and failed other conservative treatments, including oral and topical nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroid injections. The records document that relief from radiofrequency ablation of genicular nerves, expected to last six months to a year, only lasted for three months. The alternative to viscosupplementation is bilateral total knee arthroplasty. Given the patients limited options and based on the current medical literature, the requested services are medically indicated. Therefore, Synvisc-One injection in both knees is medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested services are medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer is board certified in orthopedic surgery and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for chiropractic care. There is sufficient support for the requested services in this patients case. The records document shoulder pain, neck pain and insomnia. The patient presented to her provider, and she was referred for chiropractic care. Prior x-rays revealed cervical subluxations. Based on the patients clinical presentation and prior imaging, chiropractic care is medically appropriate. The medical evidence supports the requested services in this clinical setting. Therefore, chiropractic care is medically necessary for the treatment of this patient. Final Result: The reviewer determined that the requested services are medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer is board certified in chiropractic care and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned

The patient has requested reimbursement and prospective authorization and coverage for subacute residential treatment center (RTC) services. Per the American Society of Addiction Medicine (ASAM) criteria, this patient meets Level 3.5 criteria for RTC services. ASAM criteria focuses on six dimensions to determine the appropriate level of care, which includes: (1) intoxication and withdrawal potential; (2) biomedical conditions; (3) emotional, behavioral and cognitive conditions; (4) readiness to change; (5) relapse, continued use, or continued problem potential; and (6) recovery environment. Given the findings, this patient meets the six ASAM dimensions to support treatment at the RTC level of care. All told, subacute RTC services provided were and are medically necessary for treatment of this patient.Final Result: The reviewer determined that the services at issue were and are medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is board certified in * and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Experimental/Investigational
Decision: Upheld

The enrollee requested authorization and coverage for Rezum: transurethral convective water vapor thermal ablation for a recent diagnosis of prostate cancer. The enrollee wishes to pursue radiation therapy to treat this condition.  He has concurrent diagnoses of chronic prostatitis and benign prostatic hyperplasia. His symptoms include difficulty initiating a urine stream and a restricted urine stream. The enrollee denied incontinence, painful urination or blood in the urine. The enrollee has tried Ciprofloxacin in the past, which has worked. Bactrim recently failed. The enrollees urologist recommended treatment with Rezum. Rezum is a system that uses water vapor therapy to decrease the size of the prostate. A search of clinical trials showed an ongoing study designed to evaluate the safety and efficacy of the Rezum system and assess its effects on urinary symptoms secondary to benign prostatic hyperplasia. The Rezum system has not yet been proven to be as safe or as effective as conventional treatments. Literature notes there is a lack of long-term follow up regarding this procedure. Currently, there is only one randomized control trial; providing data for a period of up to 48 months as part of a five-year trial. Further evidence and longer-term data are required to demonstrate the benefits provided by Rezum can be sustained. Since there is lack of any peer-reviewed article in the medical literature that supports the use of this treatment for those with prostate cancer. This procedure is approved by a government body for treating benign enlargement of the prostate. Literature describes the procedure as demonstrating significant improvements in symptom score, flow rate, and prostate volume reduction. However, the authors note the need for real-world data in comparison with other minimally invasive office-based therapies. Rezum has not been utilized in a randomized control trial of individuals with larger prostate size, or those with significant outflow obstruction. Additionally, those with a history of urinary retention or urinary tract infections have been excluded from the studies.Final Result: Two of the three reviewers determined that the requested service is not likely to be more beneficial than any available standard therapy for treatment of the enrollees medical condition. Credentials/Qualifications: Three reviewers are board certified in urology and are actively practicing.  All three reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Experimental/Investigational
Decision: Overturned

A 53-year-old female enrollee has requested biofeedback therapy for the treatment of her fecal incontinence. Findings:  Three physician reviewers found that this patient had fecal incontinence and underwent a biofeedback session for her incontinence issue. Review of the relevant medical literature reveals adequate evidence that biofeedback results in positive outcomes in this patient population. Given the lack of treatment options available for the patients condition, the use of biofeedback therapy was medically reasonable and appropriate.
Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The parent of an enrollee has requested authorization and coverage for AMONDYS 45 (casimersen) weekly infusions.Findings: Three out of three physician reviewers found that the requested medication is likely to be more beneficial than any other available standard treatments for the enrollee's medical condition.Duchenne muscular dystrophy (DMD) is a rare, progressive, neuromuscular disease. The disorder is inherited in an X-linked recessive fashion and is caused by loss-of-function mutations in the DMD gene coding for dystrophin, a cytoskeletal protein that stabilizes the plasma membrane of muscle fibers. Most treatments currently available for DMD are palliative and are aimed at prolonging the patients ability to walk and at improving breathing and cardiac function. Treatment with corticosteroids has been found to be the most effective option for patients, resulting in improved muscle strength, prolongation of the ability to walk, and better pulmonary function. However, corticosteroids only delay disease progression, and treatment is associated with significant side effects, including weight gain, osteoporosis, and cataracts (Hendricksen, R., et al.).Casimersen (Amondys 45) is a phosphorodiamidate morpholino oligomer designed to bypass frameshift DMD mutations and produce internally truncated, yet functional, dystrophin protein in patients amenable to exon 45 skipping. On February 25, 2021, the U.S. Food and Drug Administration (FDA) approved the drug via the accelerated approval pathway (Fast Track and Priority Review designations). Amondys 45 also received Orphan Drug designation. The FDA based their approval on interim efficacy at Week 48 of the Phase 3 of the ESSENCE trial, which is still ongoing and expected to conclude in 2024. Interim results at week 48 showed that the patients who received Amondys 45 had a statistically greater increase in dystrophin protein levels in skeletal muscle compared to patients on placebo (P =0.004). Wagner and colleagues have reported that casimersen was well tolerated in participants with DMD amenable to exon 45 skipping. Under these circumstances, the requested AMONDYS 45 (casimersen) weekly infusions are likely to be more beneficial than any other available standard treatments for the patients medical condition.Final Result: The reviewers determined that the requested medication is likely to be more beneficial than any other available standard treatments for the patient's medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: Physician reviewers 1, 2 and 3 are board certified in neurology with special qualification in child neurology and are actively practicing. All three reviewers are experts in the treatment of the enrollees medical condition and are knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.