Persius/hicric huggingface dataset:
Appeal type: Drugs
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve Keytruda. 
 
You asked the Plan to pre-approve Keytruda. You say that the requested drug is required to treat the enrollee's 
diagnosis. The Plan denied your request. The Plan says the requested drug does not meet the requirements to be 
approved. 
 
The Plan must follow Medicare rules. The rules say that Medicare may pay for unlabeled uses for anti-cancer 
drugs if they are medically accepted as safe and effective or appropriate for the particular use.  
 
 
  We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to 
determine if the Plan was correct in denying the request to pre-approve Keytruda. Our reviewer says that the 
requested drug does not meet the criteria necessary for approval. Our physician reviewer found the requested 
use of Keytruda is not FDA-approved for the enrollee's diagnosis and is not supported by one of the major drug 
compendia or by clinical research that appears in a CMS-approved medical journal. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of Keytruda have not been met. Therefore, we decided that the Plan does not have 
to pre-approve Keytruda.
Appeal type: Practitioner Services
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve an epidural steroid injection. 
 
You asked the Plan to pre-approve an epidural steroid injection. You say that the services are necessary. The 
Plan denied your request. The Plan says based on the documentation provided, coverage criteria has not been 
met. 
 
The Plan follows Medicare rules. Medicare rules say that an epidural steroid injection (ESI) will be considered 
medically reasonable and necessary when certain requirements are met. 
 
We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to 
determine if the Plan was correct in denying the request to pre-approve an epidural steroid injection. Our 
reviewer says that the services are not medically necessary. Our physician reviewer found there is no 
documentation indicating that the previous epidural steroid injection on December 21, 2023 provided 50% of 
sustained improvement in pain relief and/or improvement in function measured from baseline using SAME 
scale for at least three months. In addition, there is no documentation provided indicating that the requested 
epidural steroid injection would be performed using a different approach, level and/or medication. The review 
has determined that the enrollee does not meet the coverage criteria detailed in the LCD. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of an epidural steroid injection have not been met. Therefore, we decided that the 
Plan does not have to pre-approve an epidural steroid injection.
Appeal type: Inpatient Hospital
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve acute inpatient rehabilitation facility (IRF) admission 
and services. 
 
You asked the Plan to pre-approve IRF care. You say that you need this care to regain strength. The Plan 
denied your request. The Plan says medical records do not support the need for an IRF admission and, your 
needs can be safely provided at another setting.  
 
The Plan must follow Medicare rules. The rules say that IRF admission is covered only when it is medically 
reasonable and necessary as described in the Medicare rules section. 
 We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to 
determine if the Plan was correct in denying the request to pre-approve IRF care. Our reviewer says that the 
requested IRF care is not considered medically reasonable and necessary based on Medicare guidelines. Our 
physician reviewer found the complexity of your nursing, medical and rehabilitation can be provided in a lower 
level of care and does not require an acute hospital inpatient stay with an interdisciplinary approach to 
rehabilitation care. You require treatment by multiple therapies, including physical therapy and occupational 
therapy, but this can be provided in a lower level of care. There is documentation that there is a reasonable 
expectation that you will be able to fully participate in and benefit from the intensive rehabilitation therapy 
program provided in an IRF, but the services required can be provided at a lower level of care.  
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of IRF care have not been met. Therefore, we decided that the Plan does not have 
to pre-approve acute inpatient rehabilitation facility (IRF) admission and services.
Appeal type: Inpatient Hospital
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve inpatient rehabilitation facility (IRF) care to be provided 
by an out-of-network (OON) provider.  
 
You asked the Plan to pre-approve OON IRF care. You say that this is medically necessary. The Plan denied 
your request. The Plan says there are in-network providers available to provide IRF care. 
 
Medicare rules say that plans can require enrollees to get care from network providers. The contract with the 
Plan says that the Plan has to pre-approve care from out-of-network providers only in cases involving 
emergencies, out of area urgent care and care that cannot be provided by network providers. 
 
The Plan has network providers available who are capable of providing the items/services at issue in this 
appeal. (Please note, items and services received in-network are still subject to any other Medicare coverage rules that apply.) We found no exception that would require the Plan to pre-approve these items/services. 
Therefore, we decided that the Plan does not have to pre-approve inpatient rehabilitation facility (IRF) care to 
be provided by an out-of-network (OON) provider.
Appeal type: Inpatient Hospital
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve acute inpatient rehabilitation facility (IRF) admission 
and services. 
 
You asked the Plan to pre-approve IRF care. You say that this is medically necessary. The Plan denied your 
request. The Plan says this does not meet the criteria.  
 
The Plan must follow Medicare rules. The rules say that IRF admission is covered only when it is medically 
reasonable and necessary as described in the Medicare rules section. 
 
We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to determine if the Plan was correct in denying the request to pre-approve IRF care. Our reviewer says that the 
requested IRF care is not considered medically reasonable and necessary based on Medicare guidelines. Our 
physician reviewer found The complexity of the patient's nursing, medical and rehabilitation needs does not 
require an acute hospital inpatient stay with an interdisciplinary approach to rehabilitation care. The patient was 
admitted for surgical repair of a femur fracture after a fall. Medical problems are stable. There are no complex 
nursing or rehabilitation needs.  
 
The patient does not require treatment by multiple therapies, including either physical therapy or occupational 
therapy, and an intensive rehabilitation therapy program. While the medical record supports a need for physical 
and/or occupational therapy, there is no documented need for intensive rehabilitation services. Medically 
necessary care can be provided in a different level of care. 
 
There is not a reasonable expectation that this patient will be able to fully participate in and benefit from the 
intensive rehabilitation therapy program provided in an IRF.  
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of IRF care have not been met. Therefore, we decided that the Plan does not have 
to pre-approve acute inpatient rehabilitation facility (IRF) admission and services.
Appeal type: Inpatient Hospital
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve acute inpatient rehabilitation facility (IRF) admission 
and services. 
 
You asked the Plan to pre-approve IRF care. You say that you need this care. The Plan denied your request. 
The Plan says medical records do not support the need for an IRF admission and, your needs can be safely 
provided at another setting.  
 
The Plan must follow Medicare rules. The rules say that IRF admission is covered only when it is medically 
reasonable and necessary as described in the Medicare rules section. 
 We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to 
determine if the Plan was correct in denying the request to pre-approve IRF care. Our reviewer says that the 
requested IRF care is not considered medically reasonable and necessary based on Medicare guidelines. Our 
physician reviewer found the complexity of your medical, rehabilitation, and nursing needs does not require 
IRF care with an interdisciplinary approach to rehabilitative care. Your rehabilitation needs can be safely 
provided in an alternate setting.  
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of IRF care have not been met. Therefore, we decided that the Plan does not have 
to pre-approve acute inpatient rehabilitation facility (IRF) admission and services.
Appeal type: Drugs
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve treatment with Zirabev (Q5118) and irinotecan (J9206). 
 
You asked the Plan to pre-approve Zirabev and irinotecan. You say that the requested regimen is a medical 
necessity for the enrollee. The Plan denied your request. The Plan says the requested regimen has been 
prescribed for an off-label, not medically accepted use. 
 
The Plan must follow Medicare rules. The rules say that Medicare may pay for unlabeled uses for anti-cancer 
drugs if they are medically accepted as safe and effective or appropriate for the particular use.  
 
We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to 
determine if the Plan was correct in denying the request to pre-approve Zirabev and irinotecan. Our reviewer 
says that treatment with Zirabev and irinotecan is not medically reasonable and necessary in this case. Our 
physician reviewer found that the enrollee has a diagnosis of stage IV sigmoid adenocarcinoma, and the requested regimen is being used as fourth-line therapy. The FDA has not stated that the requested drug is 
indicated for the enrollee's condition. The Medicare-approved cancer-drug compendia do not contain a 
supportive citation for the use of the requested drug in the enrollee's specific clinical situation. No literature 
from Medicare-approved cancer journals was submitted for review. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of Zirabev and irinotecan have not been met. Therefore, we decided that the Plan 
does not have to pre-approve treatment with Zirabev (Q5118) and irinotecan (J9206).
Appeal type: Inpatient Hospital
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve acute inpatient rehabilitation facility (IRF) admission 
and services. 
 
You asked the Plan to pre-approve IRF care. You say that a lower level of care is not sufficient or safe to 
provide the enrollee the services needed for optimal recovery. The Plan denied your request. The Plan says an 
IRF admission is not medically necessary, but skilled therapies as an outpatient, home with home healthcare, or 
at a skilled nursing facility (SNF) may be approved upon request.  
 
The Plan must follow Medicare rules. The rules say that IRF admission is covered only when it is medically 
reasonable and necessary as described in the Medicare rules section.  
We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to 
determine if the Plan was correct in denying the request to pre-approve IRF care. Our reviewer says that the 
requested IRF care is not considered medically reasonable and necessary based on Medicare guidelines. Our 
physician reviewer found the complexity of the enrollee's nursing, medical and rehabilitation needs does not 
require an acute hospital inpatient stay with an interdisciplinary approach to rehabilitation care. The enrollee's 
medical problems are stable and there are no complex nursing or rehabilitation needs. The enrollee does not 
require treatment by multiple therapies, including either physical therapy or occupational therapy, and an 
intensive rehabilitation therapy program. While the medical record supports a need for physical and/or 
occupational therapy, there is no documented need for intensive rehabilitation services. Medically necessary 
care can be provided in a different level of care. There is not a reasonable expectation that the enrollee will be 
able to fully participate in and benefit from the intensive rehabilitation therapy program provided in an IRF.  
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of IRF care have not been met. Therefore, we decided that the Plan does not have 
to pre-approve acute inpatient rehabilitation facility (IRF) admission and services.
Appeal type: Inpatient Hospital
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve acute inpatient rehabilitation facility (IRF) admission 
and services. 
 
You asked the Plan to pre-approve IRF care. You say that the enrollee can tolerate the required therapy and 
will receive the appropriate level of care in the acute rehabilitation setting. The Plan denied your request. The 
Plan says an IRF admission is not medically necessary, but skilled therapies as an outpatient or at a skilled 
nursing facility (SNF) may be approved upon request.  
 
The Plan must follow Medicare rules. The rules say that IRF admission is covered only when it is medically 
reasonable and necessary as described in the Medicare rules section.  
We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to 
determine if the Plan was correct in denying the request to pre-approve IRF care. Our reviewer says that the 
requested IRF care is not considered medically reasonable and necessary based on Medicare guidelines. Our 
physician reviewer found the complexity of the enrollee's nursing, medical and rehabilitation needs does not 
require an acute hospital inpatient stay with an interdisciplinary approach to rehabilitation care. The enrollee's 
medical problems are stable and there are no complex nursing or rehabilitation needs. The enrollee does not 
require treatment by multiple therapies, including either physical therapy or occupational therapy, and an 
intensive rehabilitation therapy program. While the medical record supports a need for physical and/or 
occupational therapy, there is no documented need for intensive rehabilitation services. Medically necessary 
care can be provided in a different level of care. There is not a reasonable expectation that the enrollee will be 
able to fully participate in and benefit from the intensive rehabilitation therapy program provided in an IRF.  
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of IRF care have not been met. Therefore, we decided that the Plan does not have 
to pre-approve acute inpatient rehabilitation facility (IRF) admission and services.
Appeal type: Practitioner Services
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve the placement of a Sprint PNS system. 
 
You asked the Plan to pre-approve the placement of a Sprint PNS system. You say that the requested service is 
required to treat the enrollee's severe pain and prevent further complications. The Plan denied your request. The 
Plan says the requested service does not meet the requirements for approval. 
 
The Plan must follow Medicare rules. Medicare rules say that items and services that are not medically 
necessary are not covered.  
 
We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to 
determine if the Plan was correct in denying the request to pre-approve the placement of a Sprint PNS system. 
Our reviewer says that the requested items/services are not considered medically reasonable and necessary in 
this case. Our physician reviewer found the procedure is the subject of ongoing clinical trials and is considered 
experimental/investigational therapy. 
 We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of the placement of a Sprint PNS system have not been met. Therefore, we 
decided that the Plan does not have to pre-approve the placement of a Sprint PNS system.
Appeal type: Inpatient Hospital
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve acute inpatient rehabilitation facility (IRF) admission 
and services. 
 
You asked the Plan to pre-approve IRF care. You say that the medical records provided support the need for 
the requested IRF admission. The Plan denied your request. The Plan says based on Medicare guidelines and 
the information we have about the enrollee's condition, they do not meet all of the factors.  
 
The Plan must follow Medicare rules. The rules say that IRF admission is covered only when it is medically 
reasonable and necessary as described in the Medicare rules section. 
 We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to 
determine if the Plan was correct in denying the request to pre-approve IRF care. Our reviewer says that the 
requested IRF care is not considered medically reasonable and necessary based on Medicare guidelines. Our 
physician reviewer found the complexity of the enrollee's nursing, medical and rehabilitation can be provided 
in a lower level of care and does not require an acute hospital inpatient stay with an interdisciplinary approach 
to rehabilitation care. The enrollee requires treatment by multiple therapies, including physical therapy and 
occupational therapy, but this can be provided in a lower level of care. There is documentation that there is a 
reasonable expectation that the enrollee will be able to fully participate in and benefit from the intensive 
rehabilitation therapy program provided in an IRF, but the services required can be provided at a lower level of 
care.  
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of IRF care have not been met. Therefore, we decided that the Plan does not have 
to pre-approve acute inpatient rehabilitation facility (IRF) admission and services.
Appeal type: Inpatient Hospital
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve LTACH services. 
 
You asked the Plan to pre-approve the LTACH services. You say that an LTACH admission is necessary for 
the enrollee to regain maximum and prior level of functioning and continue multidisciplinary approach to care. 
The Plan denied your request. The Plan says they will continue to cover medically necessary acute and critical 
care at the current facility until the enrollee's condition is stable for transfer to an alternate level of care (such as 
a skilled nursing facility), or until the clinical circumstances change such that LTACH may be reconsidered. 
 
The Plan must follow Medicare rules. The rules say that LTACH services are covered if they are medically 
necessary, reasonable, and appropriate for the diagnosis and condition of the enrollee. 
 
We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to 
determine if the Plan was correct in denying the request to pre-approve the LTACH services. Our reviewer says 
that the requested LTACH care is not considered medically reasonable and necessary in this case. Our 
physician reviewer found the enrollee suffered a gunshot wound to the face and subsequently underwent a face transplant. They were admitted to the hospital for peritonitis secondary to colon perforation from diverticulitis. 
Their hospital stay has required colectomy with Hartmann procedure and been complicated by acute hypoxic 
respiratory failure, acute kidney injury requiring dialysis, and percutaneous endoscopic gastrostomy (PEG) 
tube and tracheostomy placement. It appears several tests are still pending that will have important implications 
about potential further interventions and ability. Our physician reviewer found that the records provided do not 
currently support that the enrollee is likely to need 25 or more days in an LTACH for ventilator weaning. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of the LTACH services have not been met. Therefore, we decided that the Plan 
does not have to pre-approve LTACH services.
Appeal type: Lab
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve GeneSight Psychotropic Assay (0345U). 
 
You asked the Plan to pre-approve GeneSight Psychotropic Assay. You say that the services are necessary. The 
Plan denied your request. The Plan says based on the documentation provided, coverage criteria has not been 
met. 
 
The Plan follows Medicare rules. Medicare rules say that the clinical record must clearly show the use of or 
intent to prescribe a drug that has known drug-gene interactions that require a PGx test to be ordered to define 
the safe use of that drug in that patient. 
 
We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to 
determine if the Plan was correct in denying the request to pre-approve GeneSight Psychotropic Assay. Our 
reviewer says that the services are not medically necessary. Our physician reviewer found based on review the 
records provided the medication has not been found to be useful in assistance with the enrollee's symptoms. 
The Medicare LCD L38394 requires the enrollee to be tried on at least one medication. The ordering 
psychiatrist must be board certified in psychiatry or neuropsychiatry. The ordering physician for this test is not 
a psychiatrist and is not boarded in psychiatry or neuropsychiatry but rather a family practitioner/internal 
medicine. Documentation does not show the improvement with the medication as the medication was not found 
to be useful. Utilizing the information from Medicare LCD L38394, this enrollee does not meet the criteria for 
GeneSight Psychotropic Assay and is not considered medically necessary and reasonable in the treatment of 
this individual. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of GeneSight Psychotropic Assay have not been met. Therefore, we decided that 
the Plan does not have to pre-approve GeneSight Psychotropic Assay (0345U).