Coverage Analysis Policy

PURPOSE

The purpose of this policy is to outline the parameters of when a Coverage Analysis (CA) is to be performed for a research study.

SCOPE

Studies that require a CA are studies that generate a charge to the patient and/or payor or the research study account, regardless of the funding source.

DEFINITIONS

Coverage Analysis: The CA is a detailed spreadsheet indicating all possible charges generated within the clinical study. It is a systematic review of clinical trial documents, published practice guidelines, and Local Coverage Determinations (LCD) and National Coverage Determinations (NCD) that determines the billing status of all items and services that are documented in the research protocol and/or research plan.

POLICY and PROCEDURES

1. An Intake Specialist from the Office of Clinical Trials Activation (OCTA) will triage all trials that are received in the OCTA office to determine if a CA is needed based on the required study documents.

2. All studies that generate a charge to either the patient/payor or research account (ZZ account) require a coverage analysis be performed regardless of the funding source.

3. The following types of studies are not required to have a coverage analysis performed:

a. No enrolled patients at UCSF (this includes ZSFG, VA, Fresno & CHO):

  • The entire clinical research population for the study is not seen at UCSF sites (i.e., patients are in a Community Clinic, Mexico, Africa, etc.).
  • The entire clinical research population may or may not be seen at UCSF and does not have to be a registered UCSF patient (assigned an MRN) (i.e., volunteers, students of UCSF, community centers, etc.).

b. When the entire study consists of non-billable procedures (i.e., interviews, questionnaires, surveys).

c. When the entire research study is only reviewing retrospective and prospective patient charts and patient medical records.

d. Observational Studies:

  • There is no investigational item or service.
    • The study is comparing two approved items/services to see if one has better results than the other.
    • Registry/data collection after an item/service has been performed to observe outcomes.
  • If there is nothing investigational about the study, it is all standard of care (nothing being done is experimental) the services are to be billed as normal. 
  • If the observational study adds anything not at the discretion of the PI.
    • It is likely for research purposes and would not be billable.
    • For example, a study which dictates dosage amounts and modifications in the Protocol would be performed for research purposes as it removes discretion from the physician. During non-research patient care, the physician as full discretion in determining what care to provide to his or her patient(s). In research, the physician's discretion is removed as the procedures to be performed are defined by the research protocol. 

e. IRB Exempt Studies:

  • DHHS regulations in 45 CRF 46.101 outlines categories of minimal risk research as being exempt from the federal policy for the protection of human subjects. 
  • The study must be submitted to the IRB for review and if approved, they will send an exempt certification letter.

f. Blood Draw Studies:

  • Studies that solely consist of blood draw(s) that are being performed at UCSF.

g. Compassionate Use (Expanded Access) Studies:

  • Studies that refer to the use of an investigational new drug (IND) outside of a clinical trial by people with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress. 
  • These studies are not considered research, although they do still require IRB approval.
  • Criteria for Compassionate Use
    • The patient has a life-threatening or serious disease or condition;
    • There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition; and
    • Potential patient benefit justifies the potential risks of the investigational drug/device.
  • These studies are not considered research, although they do still require IRB approval.
  • Trials that may not need a Coverage Analysis
    • Sponsor will provide drug/device free of charge;
    • Sponsor will not be paying for any services/procedures;
    • No services/procedures outside of conventional care services will be performed; and
    • No transmittal of data to the Sponsor.
  • Coverage Analysis exemption for Compassionate Use studies will be determined by the Coverage Analysis team.
  • For general questions related to Coverage Analysis and Compassionate Use studies, please contact [email protected]

REFERENCES:

CMS NCD 310.1 Routine Costs in a Clinical Trial