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Decision: unknown

The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules says that effective for items and services furnished on or after July 9, 2007, Medicare covers the 
routine costs of qualifying clinical trials, as such costs are defined below, as well as reasonable and necessary 
items and services used to diagnose and treat complications arising from participation in all clinical trials. All 
other Medicare rules apply. Routine costs of a clinical trial include all items and services that are otherwise 
generally available to Medicare beneficiaries (i.e., there exists a benefit category, it is not statutorily excluded, 
and there is not a national non-coverage decision) that are provided in either the experimental or the control 
arms of a clinical trial except: 
The investigational item or service, itself unless otherwise covered outside of the clinical trial. 
Items and services provided solely to satisfy data collection and analysis needs and that are not used in 
the direct clinical management of the patient (e.g., monthly CT scans for a condition usually requiring 
only a single scan); and  Items and services customarily provided by the research sponsors free-of-charge for any enrollee in the 
trial. 
Routine costs in clinical trials include:  Items or services that are typically provided absent a clinical trial (e.g., conventional care);  Items or services required solely for the provision of the investigational item or service (e.g., 
administration of a noncovered chemotherapeutic agent), the clinically appropriate monitoring of the 
effects of the item or service, or the prevention of complications; and  Items or services needed for reasonable and necessary care arising from the provision of an 
investigational item or service in particular, for the diagnosis or treatment of complications. 
 
This policy does not withdraw Medicare coverage for items and services that may be covered according to 
Local Coverage Determinations (LCDs) or the regulations on category B investigational device exemptions 
found in 42 CFR 405.201-405.215, 411.15, and 411.406. For information about LMRPs, refer to 
www.lmrp.net, a searchable database of Medicare Administrative Contractor local policies. For non-covered 
items and services, including items and services for which Medicare payment is statutorily prohibited, 
Medicare only covers the treatment of complications arising from the delivery of the non-covered item or 
service and unrelated reasonable and necessary care. However, if the item or service is not covered by virtue of 
a national non-coverage policy in Pub. 100-03, National Coverage Determination (NCD) Manual, and is the 
focus of a qualifying clinical trial, the routine costs of the clinical trial (as defined above) will be covered by 
Medicare but the noncovered item or service, itself, will not. You can find this in the National Coverage 
Determination (NCD) for Routine Costs in Clinical Trials (310.1).  
 
The rules say that medically necessary services are those that are reasonable and necessary for the diagnosis or 
treatment of an illness or injury. Medically necessary services include services to improve the functioning of a 
malformed body member. You can find this rule in the Social Security Act, Section 1862(a)(1)(A). 
 
 
 
The rules say that services that are not medically necessary are not covered. The rules also say that 
experimental and investigational services and devices are not covered. You can find this rule at 42 CFR 
Sections 411.15 and 411.15(o). 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.