Medical Research Billing Compliance

Medical Research Billing Compliance seeks to ensure that medical researchers employ proper billing practices. This website contains resources about how to bill for services provided as part of a research study and about the laws and regulations governing billing procedure.

Billing Information

Medical Research Billing Compliance acknowledges the School's efforts to achieve correct coding and adequate documentation and to ensure that all aspects of medical billing and collections are handled in accordance with applicable laws and regulations.

Qualifying Trials

Determine if a clinical trial meets Medicare's qualifying criteria and examine the criteria for determination of routine costs of a qualifying trial (not applicable to device trials).

Insurance Policies

Medical Research Billing Compliance has gathered useful information regarding insurance policies, Medicare, and clinical trials to aid in the billing process.


Devices are recognized in the official National Formulary, or the U.S. Pharmacopeia, or any supplement to them.

Anti-Cancer Off-Label Drug Approval

Medicare may cover FDA approved drugs used for purposes other than what is indicated on the official label if Medicare determines the use to be medically accepted.

Other Resources

This webpage provides links to useful resources such as YSM Grants and Contracts, Clinical Research Compliance Newsletter, Billing Compliance Program Manual, and Human Subjects Protection Training.

Clinical Research Training

Compliance Hotline

Call YSM's anonymous medical billing hotline if you have concerns about medical billing compliance that you are unable to report to your supervisor or to the Compliance Officer.

The hotline, operated by Compliance Concepts, is available twenty-four hours a day and can be accessed at 1-877-360-YALE.

Expanded Access to Investigational Drugs for Treatment Use
  1. FDA information regarding expanded access of investigational drugs (pdf) click here
  2. Expanded Access to Investigational Drugs for Treatment useĀ  (pdf) click here
  3. Charging for Investigational drugs (pdf) click here
  4. Physician request for an Individual Patient IND under Expanded Access for Non-emergency or Emergency Use (pdf) click here