Device Billing Guidance

Prior to enrolling ANY MEDICARE PATIENTS in an IDE trial, or using an HDE device in clinical care, you must receive written approval for both Medicare Part A and Part B coverage (Facility and Provider) from Noridian Administrative Services (the Medicare payment contractor).

Compliance Risk for Improper Billing

If required processes are not followed and/or approvals are not obtained in advance of submitting a claim to Noridian, Medicare's local contractor, the risks to both hospital and physician claims include:

• No payment for services rendered
  • Payment denial
  • Denial may include up to the full hospital stay and profees
  • Improper payment with subsequent repayment
• Possible false claims risk

Link to UW Medicine Compliance Device Coverage and Billing Guidelines: Click Here

Copies of documents that will be needed for Noridian device coverage requests:

• FDA IDE approval letter, or FDA HDE approval letter
• IRB approval letter(s)
• Protocol/Billing Grid Plan
• Clinical Protocol
• IRB approved Patient Consent Form
• Agreement(s) between sponsor and PI
• Internal (PI) budget
• UW FedEx Account Number and contact information

Noridian IDE Application

• Instructions to complete Nordian IDE application: Click Here
  • Part A: Click Here
  • Part B: Click Here
• UW Medicine's Key Steps for IDE studies conducted at the hospitals: Click Here

Nordian HDE Application

• Contact Scott Desmond
• UW Medicine's Key Steps for using HDE devices at the hospitals: Click Here

Medicare may provide reimbursement for some investigational devices and related services. Services may be furnished in preparation for device use, contemporaneously with, and necessary to the use of the device, and as follow-up care after device use. Coverage is contingent on the Medicare contractor's approval of the application for reimbursement. For additional information please visit the following websites:

• Noridian Part A: Investigational Device Exemption (IDE) Information

• Noridian Part A: Post Market Studies & Post-Market Extension Studies

• Noridian Part B: Investigational Device Exemption (IDE) Information

• Medicare and FDA References: Click Here

Amendments and Renewals 

A copy of the IRB approval letter for any time extension or other update must also be submitted to Noridian after the initial approval occurs.

Questions, Comments, Feedback

Contact UW Medicine Compliance at 206-543-3098.