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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 CMS released an updated guidance document on November 20, 2014 that describes
coverage with evidence development (CED). CMS, as part of the national coverage determination (NCD) may
determine coverage of an item or service only in the context of a clinical study. The NCDs requiring CED are
listed to the left - clicking on an NCD will lead to a listing of approved clinical studies for that specific NCD.
You can find the guidance in the CMS.gov Coverage with Evidence Development.
Medicare guidance says Transcatheter aortic valve replacement (TAVR - also known as TAVI or transcatheter
aortic valve implantation) is a new technology for use in treating aortic stenosis. A bioprosthetic valve is
inserted percutaneously using a catheter and implanted in the orifice of the native aortic valve.
CMS issued a Medicare National Coverage Determination on May 1, 2012 which allows coverage of TAVR
under Coverage with Evidence Development (CED) with certain conditions. The complete determination is
available on our website. As part of CED, we are identifying below the Medicare approved registry and
Medicare approved clinical trials which have been reviewed and determined to meet the requirements of
coverage.Registry ApprovalsSTS/ACC Transcatheter Valve Therapy (TVT) RegistryClinicalTrials.gov
number: NCT01737528https://www.ncdr.com/TVT/Home/Default.aspx, You can find the guidance in the
CMS.gov Transcatheter Aortic Valve Replacement.
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 310.1.69.2 - Payment for Qualifying Clinical Trial Services 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 study's page and is
always preceded by the letters NCT.  Contractors verify the validity of a trial/study/registry by consulting
CMS's clinical trials/registry web site at: http://www.cms.gov/Medicare/Medicare-General-
Information/MedicareApprovedFacilitie/index.html.290  Transcatheter Aortic Valve Replacement
(TAVR)For services furnished on or after May 1, 2012, the Centers for Medicare & Medicaid Services (CMS)
covers transcatheter Aortic Valve replacement (TAVR). See National Coverage Determinations (NCD) Manual
(Pub.100- 03) Chapter 20, Section 32 for complete coverage guidelines.290.1  Coding Requirements for
TAVR Furnished on or After May 1, 2012The following are the IDC-10 procedure codes applicable for TAVR:
35.05 = 024F37Z, 02RF38Z, 02RF3JZ, 02RF3KZ. You can find the guidance in the Medicare Claims
Processing Manual Chapter 32  Billing Requirements for Special Services 69  Qualifying Clinical Trials
69.1  General, 69.2, 290, 290.2.
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.