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

 
We decided that the Plan does not have to pre-approve Keytruda (J9271). 
 
You asked the Plan to pre-approve Keytruda. You say that the enrollee needs this drug. The Plan denied your 
request. The Plan says the requested use for Keytruda is not approved by the Food and Drug Administration 
(FDA) for the enrollee's condition. 
 
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, Keytruda, is not medically necessary. Our physician reviewer found the requested use of 
Keytruda is not FDA-approved for the enrollees diagnosis. The reviewer found that the requested use is not 
supported by one of the major drug compendia or by clinical research that appears in a CMS-approved medical 
journal either. The reviewer found that the enrollee's PDL1 (programmed death-ligand 1) is less than one. 
Therefore, the reviewer found that the requested drug is not medically necessary. 
 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 (J9271).
Appeal type: Other
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve transcatheter aortic valve replacement (TAVR) (33361). 
 You asked the Plan to pre-approve TAVR. You say that the services are necessary. The Plan denied your 
request. The Plan says the enrollee is a part of a clinical trial. Original Medicare covers the routine costs of 
qualifying clinical trials. 
 
The Plan must follow Medicare rules. The rules say that Original Medicare pays for the routine costs of 
qualifying clinical trials. Enrollees in a Medicare plan receive the same coverage for qualifying clinical trials as 
people enrolled in Original Medicare. The Plan must cover only the difference between the cost-sharing in 
Original Medicare and the plan cost-sharing for the same services. 
 
In this case, you asked the Plan to pre-approve TAVR as part of a clinical trial. The Plan does not cover routine 
costs associated with qualifying clinical trials. Therefore, we decided that the Plan does not have to pre-
approve transcatheter aortic valve replacement (TAVR) (33361).
Appeal type: DME/ Orthotics
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve a portable ventilator. 
 
You asked the Plan to pre-approve these services. You say that you disagree with the denial. The Plan denied 
your request. The Plan says the services are not medically necessary. 
 
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 these services. Our reviewer says that 
the services are not medically necessary. Our physician reviewer found the records show you have obstructive 
sleep apnea (OSA). The record does not indicate that you have thoracic restrictive disease. You were 
successfully treated with bi-level positive airway pressure (BiPAP) therapy. The use of a portable ventilator is 
not supported by the submitted documentation and is not reasonable or medically necessary. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of these services have not been met. Therefore, we decided that the Plan does not 
have to pre-approve a portable ventilator.
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 requires daily care to help improve 
functional status, strength and endurance for a safe discharge home. The Plan denied your request. The Plan 
says the enrollee can receive care in another setting such as a skilled nursing facility. 
 
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 that the enrollee would not be able to benefit from intensive therapy as they are 
temporarily non-weight-bearing. The enrollee does not require intensive therapy or physiatry oversight. 
 
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 Emgality. 
 
You asked the Plan to pre-approve Emgality. You say that other medications the enrollee has tried have been 
ineffective. The Plan denied your request. The Plan says Emgality is on the self-administered drug list and is 
excluded from coverage under Part B. 
 
The Plan must follow Medicare rules. The rules say that Medicare Part B generally does not pay for self-
administered drugs. The self-administered drugs requested here are not among the types which are covered by 
Medicare Part B. Therefore, we decided that the Plan does not have to pre-approve Emgality.  
 
  Benefits for Emgality may be available under Medicare Part D. Contact the Plan that administers Part D 
benefits for further information concerning any benefits and appeal rights.
Appeal type: Drugs
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve Voriconazole 50MG tablet (J8499). 
 
You asked the Plan to pre-approve the medication. You say that the medication is necessary. The Plan denied 
your request. The Plan says Voriconazole is 'self-administered' and is not covered by Medicare Part B. 
 
The Plan must follow Medicare rules. The rules say that Medicare Part B generally does not pay for self-
administered drugs. The self-administered drugs requested here are not among the types which are covered by 
Medicare Part B. Therefore, we decided that the Plan does not have to pre-approve Voriconazole 50MG tablet 
(J8499).   
Benefits for the medication may be available under Medicare Part D. Contact the Plan that administers Part D 
benefits for further information concerning any benefits and appeal rights.
Appeal type: Practitioner Services
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve transcatheter closure of cardiac paravalvular leak-
paravalvular regurgitation plug. 
 
You asked the Plan to pre-approve transcatheter closure of cardiac paravalvular leak-paravalvular regurgitation 
plug. You say that transcatheter closure of cardiac paravalvular leak-paravalvular regurgitation plug is 
medically necessary. The Plan denied your request. The Plan says transcatheter closure of cardiac paravalvular 
leak-paravalvular regurgitation plug is experimental/investigational. 
 
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 transcatheter closure of cardiac 
paravalvular leak-paravalvular regurgitation plug. Our reviewer says that the requested transcatheter closure of 
cardiac paravalvular leak-paravalvular regurgitation plug is not considered medically reasonable and necessary. 
Our physician reviewer found that the requested procedure would be considered investigational/experimental 
for closure of aortic-RV fistula/trans-catheter aortic valve replacement (TAVR) leak. As a result, at this time the requested procedure would not be considered medically necessary in your clinical management based on 
the submitted documentation. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of transcatheter closure of cardiac paravalvular leak-paravalvular regurgitation 
plug have not been met. Therefore, we decided that the Plan does not have to pre-approve transcatheter closure 
of cardiac paravalvular leak-paravalvular regurgitation plug.
Appeal type: Surgery
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve the insertion, subcutaneous cardiac rhythm monitor, 
including programming (33285). 
 
You asked the Plan to pre-approve the implantable loop recorder. You say that you are requesting an appeal for 
the denial for the implantable loop recorder. The Plan denied your request. The Plan says based on the 
information provided, this request is not medically necessary. 
 
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 implantable loop recorder. Our 
reviewer says that the requested items/services are not considered medically reasonable and necessary in this 
case. Our physician reviewer found while the enrollee has exhibited atrial fibrillation, there is no 
documentation provided to suggest a history of unexplained syncope, cryptogenic stroke or any other apparent indication for an implantable loop recorder. In summary, there is insufficient documentation to support the 
medical necessity for insertion of an implantable loop recorder in this enrollees clinical management. 
 
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 implantable loop recorder have not been met. Therefore, we decided that the 
Plan does not have to pre-approve the insertion, subcutaneous cardiac rhythm monitor, including programming 
(33285).
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 is medically appropriate for an IRF level 
of care. The Plan denied your request. The Plan says based on Medicare guidelines, the requested IRF services 
do not meet the requirements for approval. 
 
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 that the complexity of the enrollees nursing, medical and rehabilitation needs does not require an acute hospital inpatient stay with an interdisciplinary approach to rehabilitation care. Medical 
problems are stable. There are no complex nursing or rehabilitation needs. While the documentation does 
support a need for physical and/or occupational therapy, there is no documented need for an intensive, multi-
disciplinary rehabilitation program. 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: DME/ Orthotics
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve the Freestyle Libre 14 Day Sensor. 
 
You asked the Plan to pre-approve the CGM. You say that the CGM is necessary. The Plan denied your 
request. The Plan says the Medicare rules have not been met. 
 
The Plan must follow Medicare rules. Medicare rules say that therapeutic CGMs are considered medically 
reasonable and necessary for enrollees with diabetes who use insulin with at least three daily administrations, 
require frequent self-adjustment of insulin dosage based on the blood glucose testing results and have had an 
in-person visit with their treating physician to assess adherence to their CGM regimen and diabetes treatment 
plan. 
 
We looked at the file and Medicare rules. The information reviewed shows the enrollee is injecting insulin once 
per day and the information shows the enrollee does not need to change their insulin dose frequently based on 
their blood sugar test results. Based on this information, we decided that Medicare rules for coverage of the CGM have not been met. Therefore, we decided that the Plan does not have to pre-approve the Freestyle Libre 
14 Day Sensor.
Appeal type: Surgery
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve the insertion of interlaminar/interspinous process 
stabilization/distraction device, without open decompression or fusion (22869). 
 
You asked the Plan to pre-approve the Vertiflex interspinous spacer procedure. You say that included with this 
letter is the clinical documentation which supports these clinical findings and medical necessity for the 
procedure. The Plan denied your request. The Plan says Vertiflex is considered experimental and 
investigational and is not covered. 
 
The Plan must follow Medicare rules. Medicare rules say that items and services that are not medically 
necessary are not covered. The rules also say that experimental and investigational devices are not covered.  
 
We looked at the file and Medicare rules. Based on this information, we decided that Medicare rules for 
coverage of the Vertiflex interspinous spacer procedure have not been met. Therefore, we decided that the Plan 
does not have to pre-approve the insertion of interlaminar/interspinous process stabilization/distraction device, 
without open decompression or fusion (22869).
Appeal type: Home Health
Decision: Unfavorable

 
We decided that the Plan does not have to pay for the home health services rendered from January 30, 2022, to 
February 28, 2022. 
 
You asked the Plan to pay for these services. You say that you disagree with the denial. The Plan denied your 
request. The Plan says the NOA was not received timely. As such, this final claim was correctly denied. 
 The Plan follows Medicare rules. The rules say that an NOA must be submitted within 5 days of the start of 
care date for home health services. NOAs which are received more than 30 days from the timely filing date 
result in no payment being made for the episode of care.  
 
In this case, the start of care date is January 30, 2022. The NOA was not received by the Plan until December 
12, 2019. As more than 30 days passed between the timely filing date and the NOA receipt, no payment can be 
made on this claim. Therefore, we decided that the Plan does not have to pay for the home health services 
rendered from January 30, 2022, to February 28, 2022.
Appeal type: DME/ Orthotics
Decision: Unfavorable

 
We decided that the Plan does not have to pay for electrical stimulator supplies (A4595) provided on June 6, 
2022. 
 
You asked the Plan to pay for electrical stimulator supplies. You say that the items at issue were a medical 
necessity for the enrollee. The Plan denied your request. The Plan says rules for payment for DMEPOS have 
not been met. 
 
The Plan must follow Medicare rules. The rules state that DMEPOS is covered only when there are both a 
physician order and proof of delivery.  
 
The record does not contain a valid proof of delivery for the supplies provided in this case. Specifically, the itemized packing slip in the case record does not adequately identify the supplies delivered as the items at issue 
in this case. The record shows that the Plan made several attempts to obtain the necessary documentation 
without success. Therefore, we decided that the Plan does not have to pay for electrical stimulator supplies 
(A4595) provided on June 6, 2022.
Appeal type: Lab
Decision: Unfavorable

 
We decided that the Plan does not have to pay for the laboratory services billed with procedure codes 87506, 
87500, 87641, 87798, and 87801 for May 8, 2021. 
 
You asked the Plan to pay for these services. You say that you disagree with the denial. The Plan denied your 
request. The Plan says the services are not billed correctly. 
 
The Plan must follow Medicare rules. Medicare rules say that a GIP test panel must not be unbundled and 
billed as individual components regardless of the fact that the GIP test panel reports multiple individual 
pathogens and/or targets.  
 
We looked at the file and Medicare rules. The file shows that the GIP test panel was billed with multiple codes. 
Based on this information, we decided that Medicare rules for coverage of these services have not been met. 
Therefore, we decided that the Plan does not have to pay for the laboratory services billed with procedure codes 
87506, 87500, 87641, 87798, and 87801 for May 8, 2021.
Appeal type: Step-Therapy
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve Abraxane. 
 
You asked the Plan to pre-approve Abraxane. You say that the enrollee has cancer and needs this drug. The 
Plan denied your request. The Plan says this request does not meet the Plan's Part B step therapy criteria for 
Abraxane. 
 Medicare covers Part B medications when they are reasonable and necessary but allows health plans to 
implement step therapy criteria. The Plan's contract indicates that it has implemented such criteria for certain 
Part B medications. 
 
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 Abraxane. Our reviewer says that the 
requested Abraxane is not shown to be currently medically necessary and reasonable. Our physician reviewer 
found the health plan requires that other forms of medications be used. There is no evidence that the enrollee is 
allergic to or intolerant of these other forms of medication. Our reviewer found that there is no evidence that 
the enrollee has tried and not responded to these other forms of medication. Our physician reviewer also found 
that there is no documentation as to why these other forms of medication would not be expected to be safe and 
effective for the enrollee. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of Abraxane have not been met. Therefore, we decided that the Plan does not have 
to pre-approve Abraxane.
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 you are requesting an LTACH for the 
enrollee as you expect they will require another three to four weeks to continue with aggressive pulmonary 
toileting and to transition from their acute illness. The Plan denied your request. The Plan says the enrollee 
does not meet the guidelines for admission to an LTACH. 
 
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 does not require services at the LTACH that are not available at the acute 
care hospital where they are currently receiving care. The requested LTACH services are not medically 
necessary, reasonable, and appropriate for the diagnosis and condition of the enrollee and able to be furnished 
safely and effectively only on an inpatient basis. 
 
 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: Drugs
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve Udenyca (Q5111). 
 
You asked the Plan to pre-approve Udenyca. The Plan denied your request. The Plan says this drug is not being 
prescribed for a medically accepted indication. The Plan also says there is no evidence of neutropenia or febrile 
neutropenia related to receiving this anti-cancer drug/regimen, and the documentation does not support that the 
enrollee has greater than a 10% risk of febrile neutropenia. 
 
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 Udenyca. Our reviewer says that 
Udenyca is not medically reasonable and necessary for the enrollee. Our physician reviewer found 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 clinical 
situation. Our reviewer found that no literature from Medicare approved cancer journals were submitted for 
review. The elements of the coverage criteria are not satisfied. Our physician reviewer also found that the 
requested service cannot be recommended. 
 We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of Udenyca have not been met. Therefore, we decided that the Plan does not have 
to pre-approve Udenyca (Q5111).