Appeal type: unknown
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 
CTprefix 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 guidance in the MLN Matters Number MM9002 Revised. 
 
Medicare guidance says "The CMS has issued a National Coverage Determination (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 National 
Coverage Determinations 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) 
Clinical Trials.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 guidance 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 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 guidance 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.