Take home message: Compliance in medical billing (or reimbursement) is heavily regulated, and is further complicated when clinical services are connected to research purposes. If you are involved in human subjects research being conducted on UMHS patients, make sure you understand the rules that apply, cooperate fully with those who monitor U-M’s billing practices, and consult with the Clinical Research Calendar Review & Analysis Office (CRAO) before engaging in any clinical research billing.
- It is the policy of the UMHS to bill only for services actually provided and medically necessary, and to bill the most appropriate payment source. This is made more complicated in the case of services that have a research purpose, because there are multiple potential payors involved – and finding the most appropriate one takes careful consideration in each case. Read more about this on the Faculty and Staff Expectations page maintained by CRAO.
- The Revenue Cycle compliance program, overseen by the Reimbursement, Compliance and Education Office [site only viewable internally at UMHS], monitors professional and facilities billing at UMHS and coordinates education and compliance efforts. .
- Clinical Research billing: The Clinical Research Calendar Review & Analysis Office (CRAO) (formerly called the Clinical Research Billing Unit, a part of the Medical School Office of Research) ensure that clinical items and services that research teams intend to bill to Medicare (or other health plans or third party payers) are consistent with federal regulations. For instance, U-M must not bill a health plan for services that are being provided for research purposes, and U-M cannot be doubly compensated for clinical services by billing a health plan and being provided with grant or sponsor funding for the same service.
- The UMHS Clinical Research Position Statement (including template language for sponsor agreements) describes the approach that should be taken with respect to research sponsors covering the costs of clinical services (as opposed to Medicare or other health plans covering those costs). Further clinical research billing resources, including forms and policies, can be found on the CRAO Resources page [U-M networks only].
- Fraud and abuse laws prohibit certain practices in the health care industry (even though they might be accepted in other sectors), and impose detailed requirements around documentation and claims submitted under government funding programs. It is crucial for all who provide clinical services; bill for health care; develop or participate in business arrangements for UMHS; or who have a financial interest in products or services purchased by UMHS, to be aware of these laws and their requirements. See the Fraud and abuse compliance page for more details.
- The rules and regulations around billing for clinical services (as well as contract terms with different insurers) are complex and change frequently – so make sure you utilize and cooperate with the UMHS experts in billing compliance, such as the Reimbursement, Compliance and Education Office and the Clinical Research Calendar Review & Analysis Office (CRAO) [U-M networks only].
- For clinical research, the billing rules are even more complex – to learn more, start by looking at the great FAQs maintained by the Clinical Research Calendar Review & Analysis Office (CRAO), and peruse the additional resources on their site.
- It is critical to make sure U-M doesn’t double dip (even unintentionally) on funding for clinical research services. Research hospitals have been required to repay large sums of money when they have failed to ensure that their billing practices, especially associated with grant funded clinical research, is compliant with federal regulations. You must submit and obtain approval for your billing plan from the CRAO staff before providing any clinical services you plan to use for research purposes.
- Thoroughly documenting clinical services provided and funding claims submitted is crucial – not only because it is the prudent thing to do, but also because it is required under fraud and abuse laws.
- If you get advice on some new billing practice, code or method (such as from a drug company or device manufacturer), check its appropriateness with someone in the Reimbursement, Compliance and Education Office before you simply start using it.
- As well as complying with billing rules in clinical research, you also need to comply with the rules relating to research, grants & sponsored research – read more about both the financial and non-financial requirements of grant management, human subjects research, and other research compliance requirements.
For most billing or reimbursement questions in the UMHS, it pays to talk to your supervisor or unit’s billing manager first.
For general billing questions, contact one of these billing compliance contacts or call the Reimbursement, Compliance and Education Office at (734) 763-7232.
For research related billing questions, contact the staff in the Clinical Research Calendar Review & Analysis Office (CRAO), by referring to their contact list (which includes a breakdown of specialists for each clinical department), or by calling (734) 998-6880 or emailing their office.
You can also direct any of your billing related compliance questions, or report potential concerns, to the UMHS Compliance Office.
Established 3/4/11, last updated 3/7/17 – Contact us if you believe any information is incorrect or outdated