The document that matches the cost language in an informed consent for adverse events and subject injury.
What is a Clinical Trial Agreement?
100
Review budget to ensure these codes are correct and billable together or separately.
What are CPT codes?
100
A process of reviewing and working with a sponsor to come to an agreement on payment?
What is negotiating Category Contract?
100
This document is considered best practice and should match the consent, budget and contract.
What is Coverage Analysis?
100
The condition code used to designate an investigational device what is provided for free.
What is 053?
200
The language not recommended in an informed consent per CMS.
What is a conditional payment clause?
200
An internal budget issue that prohibits anyone from knowingly or willfully paying or receiving remuneration in exchange for referrals or the purchase of any item or service that may be paid for by a federal health care program.
What is Anti-Kickback?
200
The portion of the contract that outlines all sponsor reimbursement.
What is the Clinical Trial Budget?
200
Conventional care, the provision of the investigational item and monitoring the toxicity associated with it are covered.
What are routine costs?
200
The documentation for an item designated billable on a coverage analysis by a physician.
What is medically necessary?
300
The explanation of what will be provided at no cost such as a drug.
What is Expected Cost Section?
300
An internal budget issue where any person who knowingly presents a false or fraudulent claim for payment.
What is False Claims Act?
300
The language in a contract that defines the responsible payor should a patient suffer an injury or illness as a result of their study participation.
What is Subject Injury Language?
300
Clinical visits, blood draws, radiology, local lab tests, procedures.
What are billing events?
300
Carrying out your daily work guided by laws, regulations and policies which govern you and ethical standards.
What is compliance?
400
A fixed sum paid to the research subject for their participation in the clinical trial outlined in the consent.
What is a patient stipend?
400
According to CMS, this is the value in arm's length transactions, consistent with the general market value.
What is Fair Market Value?
400
The language not recommended in consent contract per CMS, as it is not compliant with the Medicare Secondary Payment rule.
What is a conditional payment clause?
400
Anything not paid for by the sponsor that is also not billable to Medicare.
What is an institution expense?
400
"Driver" of reimbursement rates in the United States.
What is Medicare?
500
It is better to have the informed consent follow these documents.
What is the budget and contract?
500
Costs incurred specifically related to conducting a particular study at your site, including all patient care costs, salary of study teams, and study specific equipment.
What are Direct Costs?
500
An additional contract required for items not provided by sponsor but needed for a study.
What is a Purchase Agreement?
500
Determines the Medicare coverage and claims processing for procedures that involve a humanitarian use device (HUD).
What is a Medicare Administrative Contractor (MAC)?
500
The ICD-10 code which must go onto a claim for a clinical trial service.