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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. 
 
Medicare guidance says "Transcatheter Mitral Valve Repair (TMVR)-National Coverage Determination (NCD) 
Effective for claims with dates of service furnished on or after August 7, 2014, the Centers for Medicare & 
Medicaid Services (CMS) will reimburse claims for TMVR for Mitral Regurgitation (MR) when furnished 
under Coverage with Evidence Development (CED).MACs shall accept the numeric, 8-digit NCT number 
preceded by the two alpha characters of CT when placed in Field 19 of paper Form CMS-1500, or when 
entered WITHOUT the CT prefix in the electronic 837P in Loop 2300 REF02 (REF01=P4). NOTE: The 
CT prefix is required on a paper claim, but it is not required on an electronic claim. TMVR for MR claim 
lines in a clinical trial billed without an 8-digit NCT number shall be returned as unprocessable. MACs will 
supply the following messages when returning TMVR for MR claim lines as unprocessable when billed 
without an 8-digit NCT number." You can find this information in the Medicare Learning Network (MLN) 
Matters Number MM9002 Revised. 
 
Medicare guidance says "The CMS has issued a NCD which allows Medicare coverage for the routine costs of 
qualifying clinical trial services as well as reasonable and necessary items and services used to diagnose and 
treat complications arising from participation in all clinical trials. The coverage requirements for routine costs 
of qualifying clinical trial services are contained in The NCD Manual, Section 310.1. For dates of service on or 
after September 19, 2000, pay for covered services furnished to beneficiaries participating in qualifying clinical 
trials. Payment is based on the payment methodology applicable for the service that was furnished (e.g., 
physician fee schedule, lab fee schedule, durable medical equipment fee schedule, reasonable charge, etc.). 
With the exception of managed care enrollees, applicable deductibles and coinsurance rules apply to clinical 
trial items and services. The Part A and Part B deductibles are assumed to be met for covered clinical trial 
services billed on a fee service basis for managed care enrollees. NOTE: Effective for claims with dates of 
service on or after January 1, 2014, it is mandatory to report a clinical trial number on claims for items/services 
provided in clinical trials/studies/registries, or under CED. This is the number assigned by the National Library 
of Medicine (NLM) ClinicalTrials.gov Web site when a new study appears in the NLM Clinical Trials data 
base. This number is listed prominently on each specific studys page and is always preceded by the letters 
NCT. Contractors verify the validity of a trial/study/registry by consulting CMSs clinical trials/registry web site at: http://www.cms.gov/Medicare/Medicare-GeneralInformation/MedicareApprovedFacilitie/index.html." 
You can find this information in the Medicare Claims Processing Manual Chapter 32-Billing Requirements for 
Special Services 69.1-General and 69.2 - Payment for Qualifying Clinical Trial Services. 
 
Medicare guidance says "The A/B MACs (A) must provide a listing of the required data elements, including a 
brief explanation to providers and suppliers. A/B MACs (A) must educate providers regarding the distinction 
between submissions which are not considered claims, but which are returned to provider (RTP) and 
submissions which are accepted by Medicare as claims for processing but are not paid. Claims may be accepted 
as filed by Medicare systems but may be rejected or denied. Unlike RTPs, rejections and denials are reflected 
on RAs. Denials are subject to appeal, since a denial is a payment determination. Rejections may be corrected 
and re-submitted. The following definitions apply to Section 80.3.2. For carriers the requirements apply to Part 
B assigned and unassigned claims (Form CMS-1500) or electronic data interchange equivalent. Unprocessable 
Claim - Any claim with incomplete or missing, required information, or any claim that contains complete and 
necessary information; however, the information provided is invalid. Such information may either be required 
for all claims or required conditionally. Incomplete Information - Missing, required or conditional information 
on a claim (e.g., no Unique Physician Identification Number (UPIN) / Provider Identification Number (PIN) or 
National Provider Identifier (NPI) when effective). Invalid Information - Complete required or conditional 
information on a claim that is illogical, or incorrect (e.g., incorrect UPIN/PIN or NPI when effective), or no 
longer in effect (e.g., an expired number). Required - Any data element that is needed in order to process a 
claim (e.g., Provider Name, Date of Service). A claim returned as unprocessable for incomplete or invalid 
information does not meet the criteria to be considered as a claim, is not denied, and, as such, is not afforded 
appeal rights. You can find this information in the Medicare Claims Processing Manual Chapter 1 - General 
Billing Requirements 70.2.3.2-Handling Incomplete or Invalid Submissions and 80.3.1 - Incomplete or Invalid 
Claims Processing Terminology. 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.