Persius/hicric huggingface dataset:
Appeal type: Step-Therapy
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve Aranesp for the enrollee. 
 
You asked the Plan to pre-approve the drug. You say that this is medically necessary. The Plan denied your 
request. The Plan says step therapy guidelines were not followed. 
 
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 the drug. Our reviewer says that the 
requested drug is not medically reasonable or necessary. Our physician reviewer found the requires a trial of 
Retacrit or Procrit before they will approve the requested drug. In this case, the patient has not tried and failed 
the required drug(s). There is no documentation indicating that the plans required drug(s) would likely be less 
effective and/or likely have adverse effects 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 the drug have not been met. Therefore, we decided that the Plan does not have 
to pre-approve Aranesp for the enrollee.
Appeal type: Practitioner Services
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve the CardioMEMS device. 
 
You asked the Plan to pre-approve the CardioMEMS device. You say that this is medically reasonable and 
necessary for the enrollee's condition. The Plan denied your request. The Plan says the requested device is 
considered 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 the CardioMEMS device. Our reviewer 
says that the requested items/services are not considered medically reasonable and necessary in this case. Our 
physician reviewer found that at issue is the medical appropriateness and necessity of implantation of the 
wireless pulmonary artery pressure monitoring system (CardioMEMS) for management of congestive heart 
failure (CHF) in this patient. The CardioMEMS device was approved by the FDA in 2014 and consists of a 
sensor device placed in the pulmonary artery to allow measurement of pulmonary artery pressure in the 
management of patients with CHF. The clinical study on which Food and Drug Administration (FDA) approval 
was based showed improved clinical outcomes and decreased hospitalizations in patients in whom the 
CardioMEMS system was implanted, reflecting a patient population with preserved ejection fraction and was 
somewhat limited in scope. Subsequent follow-up studies remain encouraging and suggest an improvement in heart failure symptoms with the use of the device. In addition, published expert opinion in the cardiology 
literature is supportive of the clinical usefulness of CardioMEMS. Nonetheless, there remains a dearth of 
randomized, blinded clinical studies examining long-term clinical outcomes establishing the value of 
CardioMEMS in patient management. As a result, at this time the CardioMEMS system would not be 
considered medically appropriate and necessary in this patients 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 CardioMEMS device have not been met. Therefore, we decided that the 
Plan does not have to pre-approve the CardioMEMS device.
Appeal type: SNF
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve admission to a skilled nursing facility (SNF). 
 
You asked the Plan to pre-approve the admission. You say that this meets the criteria. The Plan denied your 
request. The Plan says the enrollee no longer meets Medicare guidelines to be given in a SNF. 
 
The Plan must follow Medicare rules. The rules say that Medicare pays for care in a SNF when the four factors 
listed in the Medicare rules section are met. Custodial care is 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 admission. Our reviewer says that 
the requested admission is not medically reasonable or necessary. Our physician reviewer found there are no 
identifiable skilled nursing service needs. There are no identifiable skilled therapy service needs. The enrollee 
does not require skilled nursing or therapy services on a daily basis. The enrollee does not meet severity of 
illness or intensity of service criteria for an inpatient basis in a skilled nursing facility 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 the admission have not been met. Therefore, we decided that the Plan does not 
have to pre-approve admission to a skilled nursing facility (SNF).
Appeal type: Practitioner Services
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve the lower leg revascularization to be provided by an out-
of-network (OON) provider. 
 
You asked the Plan to pre-approve the lower leg revascularization. You say that this medical care is medically 
necessary. The Plan denied your request. The Plan says there are multiple in-network providers available to 
provide this medical 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 requested provider in this case is not a network provider with the Plan. The Plan has network providers 
available who can provide the items/services at issue in this appeal. 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 
the lower leg revascularization to be provided by an out-of-network (OON) provider.
Appeal type: Practitioner Services
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve a guided tissue regeneration (D4266x4), a complete 
lower overdenture (D5865), a surgical placement of an implant body, endosteal implant (D6010x4), a bone 
graft at time of implant placement (D6104) and a precision attachment (D6950). 
 
You asked the Plan to pre-approve dental services. You say that the requested services should be covered 
because you need these services to be able to eat. The Plan denied your request. The Plan says the requested 
services are not a covered benefit with your Plan. 
 
Medicare generally does not cover dental services. However, the Plan offers a dental benefit that exceeds 
Medicare coverage. For that reason, the Plans coverage rules apply in this case. 
 
Though the Plan offers a dental benefit in excess of Medicare coverage, the requested items or services are not 
among those covered under this benefit. Therefore, we decided that the Plan does not have to pre-approve a 
guided tissue regeneration (D4266x4), a complete lower overdenture (D5865), a surgical placement of an 
implant body, endosteal implant (D6010x4), a bone graft at time of implant placement (D6104) and a precision 
attachment (D6950).
Appeal type: DME/ Orthotics
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve a generator, neurostimulator (implantable), non-
rechargeable with carotid sinus baroreceptor stimulation lead (C1825) to be provided by an out-of-network 
(OON) provider. 
 
You asked the Plan to pre-approve a generator. You say that the requested device is medically necessary for the 
enrollee. The Plan denied your request. The Plan says the hospital provider is not listed in the enrollee's health 
plan. 
 
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 requested provider in this case is not a network provider with the Plan. The Plan has network providers 
available who can provide the items/services at issue in this appeal. 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 
a generator, neurostimulator (implantable), non-rechargeable with carotid sinus baroreceptor stimulation lead 
(C1825) to be provided by an out-of-network (OON) provider.
Appeal type: Practitioner Services
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve image-guided radiation therapy (IGRT). 
 
You asked the Plan to pre-approve IGRT. You say that the requested therapy is medically necessary. The Plan 
denied your request. The Plan says the requested therapy does not meet criteria. 
 The Plan must follow Medicare rules. The rules say that Medicare pays for medically necessary outpatient 
therapy. 
 
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 IGRT. Our reviewer says that skilled 
services are not necessary to restore or maintain function or to prevent deterioration of the enrollee's condition. 
Our physician reviewer found usually IGRT is used when critical structures are abutting or in close proximity 
to the target that is being treated to high doses. This situation does not apply to the enrollee for which the target 
lesion can be seen on the skin to assist in daily set up. When treating skin cancers, there is generally not a need 
for IGRT unless deep structures are being treated. There is no data to suggest that treatment depth should be 
changed in the midst of treatment based upon treatment response, and none are provided in the case file. 
Certainly, using ultrasound on a daily basis is not unreasonable, but to bill for daily simple simulations or 
IGRT for a technology for which need has not been established by published data or supported by consensus 
guidelines would not be furnished in accordance with accepted standards of medical practice. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of IGRT have not been met. Therefore, we decided that the Plan does not have to 
pre-approve image-guided radiation therapy (IGRT).
Appeal type: Drugs
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve Durolane injection services. 
 
You asked the Plan to pre-approve Durolane injection services. You say that this drug is medically reasonable 
and necessary. The Plan denied your request. The Plan says Durolane injection services are not medically 
reasonable and necessary. 
 
The Plan must follow Medicare rules. The rules say that Medicare pays for a drug or biological only if it is safe 
and effective and otherwise reasonable and necessary.  
 
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 Durolane injection services. Our 
reviewer says that the requested Durolane injections are not medically reasonable and necessary. Our physician 
reviewer found this 72-year-old woman has osteoarthritis of her right knee. She received an injection of 
Duralane on February 14, 2022, and was seen 6 weeks later with 7/10 pain. She has had physical therapy and 
other conservative therapy. In this case, Durolane did not provide significant long-lasting relief.  
Viscosupplementation failed to provide relief and therefore, the injection should not be repeated. The request is 
not medically reasonable or 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 Durolane injection services have not been met. Therefore, we decided that the 
Plan does not have to pre-approve Durolane injection services.
Appeal type: Inpatient Hospital
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve admission to an inpatient rehabilitation facility (IRF) for 
the enrollee. 
 
You asked the Plan to pre-approve IRF care. You say that this is medically necessary. The Plan denied your 
request. The Plan says the enrollee does not meet the Medicare criteria for admission to an Inpatient 
Rehabilitation Facility (IRF). 
 
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 
has a past medical history of congestive heart failure, pulmonary hypertension, and atrial fibrillation, and is 
living at home with ongoing weakness, despite home health physical therapy. Medical problems are stable. 
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 this 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 admission to an inpatient rehabilitation facility (IRF) for the enrollee.
Appeal type: Imaging
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve an office visit, electrocardiogram (ECG), computed 
tomography (CT) scan of the abdomen and pelvis, and CT scan of the thorax to be provided by an out-of-
network (OON) provider. 
 
You asked the Plan to pre-approve an office visit, ECG, CT scan of the abdomen and pelvis, and CT scan of 
the thorax. You say that the services are necessary. The Plan denied your request. The Plan says there are in-
network providers that are able to provide these services. Therefore, coverage criteria have not been met. 
 
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 requested provider in this case is not a network provider with the Plan. The Plan has network providers 
available who can provide the items/services at issue in this appeal. 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 an office visit, electrocardiogram (ECG), computed tomography (CT) scan of the abdomen and pelvis, and CT 
scan of the thorax 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 admission to an inpatient rehabilitation facility (IRF). 
 
You asked the Plan to pre-approve IRF care. You say that this is medically necessary. The Plan denied your 
request. The Plan says the services can be safely received in other settings. 
 
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 needs does not require an 
acute hospital inpatient stay with an interdisciplinary approach to rehabilitation care. You were admitted for 
surgical repair of a hip fracture after a fall and a post-op hip infection. Medical problems are stable. There are no complex nursing or rehabilitation needs. You do 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 you 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 admission to an inpatient rehabilitation facility (IRF).
Appeal type: Drugs
Decision: Favorable

 
We decided that the Plan has to pre-approve Keytruda. 
 
You asked the Plan to pre-approve Keytruda. You say that this drug is medically reasonable and necessary for 
the enrollee's condition. The Plan denied your request. The Plan says that the criteria for the requested drug 
have not been met. 
 
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 is medically reasonable and necessary. Our physician reviewer found the enrollee has been 
diagnosed with anaplastic thyroid cancer with a PDL1 of 60%. In this case, the tumor mutational burden 
(TMB) is low and microsatellite instability (MSI) is not high. The requested drug Keytruda is not FDA-
approved for the enrollee's condition. However, the use of Keytruda for the enrollee's condition is supported by 
one of the major drug compendia or by clinical research that appears in a CMS-approved medical journal. 
Specifically, it is supported in an article titled "Combination of Lenvatinib and Pembrolizumab Is an Effective 
Treatment Option for Anaplastic and Poorly Differentiated Thyroid Carcinoma." The requested drug is 
medically reasonable and necessary for the enrollee's condition. 
 
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 been met. Therefore, we decided that the Plan has to pre-approve 
Keytruda.  
 
If the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again 
if we believe there was a mistake or if there is new information to review. The Plan has to show us the mistake 
and/or send us the new information. This does not happen often. If we decide to open the case again, we will 
send you a letter.
Appeal type: Imaging
Decision: Partially Favorable

 
We decided that the Plan has to pre-approve IGRT. We decided that the Plan does not have to pre-approve 
IMRT.  
 
You asked the Plan to pre-approve IMRT and IGRT. You say that the requested services are medically 
necessary. The Plan says that the requested do not meet criteria and are not medically necessary. 
 
We decided that the Plan has to pre-approve IGRT.   
 
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 IGRT. Our reviewer says that the 
requested items/services are considered medically reasonable and necessary in this case. Our physician 
reviewer found while there is no specific justification for IGRT, IGRT would be standard of care when treating 
a bladder cancer, even with palliative intent (and is required by the SWOG S1806 study establishing a basis for 
need). 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of IGRT have been met. Therefore, we decided that the Plan has to pre-approve 
IGRT.  
 
We also decided that the Plan does not have to pre-approve IMRT. 
 
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 IMRT. Our reviewer says that the 
requested items/services are not considered medically reasonable and necessary in this case. Our physician 
reviewer found the medical records do not offer an explanation as to why, or offer a quantifiable rationale, for 
why IMRT is needed in this patient. No specific information about a 3D conformal plan being unacceptable 
was provided. IMRT is necessary when the need is sufficiently supported. Without justification for the need of 
IMRT (over standard 3D conformal radiotherapy) the LCD criteria are not met. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of IMRT have not been met. Therefore, we decided that the Plan does not have to 
pre-approve IMRT. 
 
If the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again 
if we believe there was a mistake or if there is new information to review. The Plan has to show us the mistake 
and/or send us the new information. This does not happen often. If we decide to open the case again, we will 
send you a letter.