UCSF Guidance: Managing Conflicts of Interest in Clinical Practice

A conflict of interest between the recipient of a referral and the referring Healthcare Provider occurs when the referring Healthcare Provider or member of their Immediate Family could benefit financially from the referral. A UCSF Healthcare Provider may not refer a patient to a non-UCSF entity if they have a financial stake in that entity (UCSF Policy 150-30 external site (opens in a new window) ). Exceptions to this require approval from the Healthcare Provider’s Section Chief or Department Chair. They must also disclose the relationship to the patient being referred and any reasonable alternatives shall be made clear. In some cases, referral to a non-UCSF entity in which the Healthcare Provider is a stakeholder, or use of a product generated by a non-UCSF entity in which the Healthcare Provider is a stakeholder, may be essential to the interests of the patient. If the Healthcare Provider deems this to be the case, they should raise the issue to the COIAC. 

These restrictions do not apply when a Healthcare Provider is referring a patient to a subunit of our Organization (e.g., but not limited to, when a physician is referring a patient to radiology, but not to a specific radiologist and the physician’s spouse works in radiology). It is emphasized that all referrals of patients be made based on the best interest of the patient.   

It should be noted that fraud, waste, and abuse is one of the most significant areas of legal exposure for every sector of the health care industry. The federal laws governing health care fraud and abuse are broad and complex, involving overlapping and intersecting legal and regulatory schemes that permeate every aspect of health care, from operations to payment, research to treatment, manufacture to supply. Conforming conduct to avoid legal liability requires a general understanding of what is prohibited, how prohibitions are enforced, and the objectives related to these prohibitions. 

To deter and combat health care fraud and abuse in federal health care programs, state and federal governments rely primarily on the handful of legal authorities, including the following: 

Physician Self-Referral Law (Stark Law): Stark Law prohibits physicians from referring patients to receive designated health services (DHS) payable by Medicare or Medicaid from entities with which the physician or physician’s immediate family member has a financial relationship (e.g., ownership, investment interest, compensation arrangement), unless an exception applies. Unlike the Anti-Kickback Statute, the Stark Law is a strict liability civil statute. 

Federal Anti-Kickback Statute (AKS): AKS makes it a criminal offense to knowingly and willfully offer, pay, solicit, or receive any remuneration to induce or reward referrals of items or services reimbursable under a Federal health care program. Where remuneration is paid purposefully to induce or reward referrals of items or services payable by a Federal health care program, the anti-kickback statute is violated. By its terms, the statute ascribes criminal liability to parties on both sides of an impermissible “kickback” transaction. [For purposes of the anti-kickback statute, “remuneration” includes the transfer of anything of value, directly or indirectly, overtly or covertly, in cash or in kind, unless an exception applies.] 

The statute has been interpreted to cover any arrangement where one purpose of the remuneration was to obtain money for the referral of services or to induce further referrals. Violation of the statute constitutes a felony punishable by a maximum fine of $100,000, imprisonment up to 10 years, or both. Conviction will also lead to exclusion from Federal health care programs, including Medicare and Medicaid. [Where a party commits an act described in section 1128B(b) of the Act, the OIG may initiate administrative proceedings to impose civil monetary penalties on such person under section 1128A(a)(7) of the Act. The OIG also may initiate administrative proceedings to exclude such person from Federal health care programs under section 1128(b)(7) of the Act.] 

Beneficiary Inducements - Civil Monetary Penalties Law (CMP): Beneficiary Inducements CMP provides for the imposition of civil monetary penalties against any person who offers or transfers remuneration to a Medicare or State health care program (including Medicaid) beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of any item or service for which payment may be made, in whole or in part, by Medicare or a State health care program (including Medicaid). The law defines “remuneration” for purposes of the Beneficiary Inducement CMP as including “transfers of items or services for free or for other than fair market value.” 

It should be noted that other fraud and abuse laws range from criminal statutory prohibitions on health care fraud and other general bad acts to state-specific versions of federal fraud and abuse statutes to common law doctrines precluding certain relationships as a matter of public policy.

Site Access to our Organization by Pharmaceutical, Diagnostic and Medical Device Non-UCSF Entity Representatives

The COIAC may allow site access to our organization by pharmaceutical, diagnostic and medical device non-UCSF entity representatives if the non-UCSF entity representative visit is of direct benefit to a patient currently being treated. If the request for site access is an urgent matter and the COIAC is not available, the Section Chief and/or Department Chair may review and allow the access.

Oversight and Responsibility

The COIAC is responsible for reviewing, revising, updating, and operationalizing this guidance document to maintain compliance with regulatory, policy or other requirements. It is the responsibility of each hospital, school, department and discipline to ensure that Healthcare Providers are aware of this guidance document and have the contact information for the COIAC.