The Patient Protection and Affordable Health Care Act, known informally as the health care reform law, went into effect on March 23, 2010, and makes several significant changes to the Stark Act.

First, the new law requires the Department of Health and Human Services (HHS) to create and implement a new Stark Act self-disclosure protocol within six months, which would allow health care entities to self-report Stark Act violations to the government. Under the new self-disclosure protocol, the Secretary of HHS will have the authority to reduce repayments and penalties for Stark Act violations, depending on provider cooperation and the timeliness of the self-disclosure. Once implemented, this new self-disclosure protocol should give providers a clear process for dealing with internally discovered Stark Act violations.

Second, the new law requires referring physicians to inform their patients of alternate suppliers of designated health services (DHS) prior to providing DHS to the patient pursuant to the in-office ancillary services exception under the Stark Act. The physician now must provide the patient with a written list of suppliers who furnish similar DHS services in the local area prior to providing the DHS under the in-office ancillary services exception.

Third, the new law prevents future physician ownership of hospitals originally allowed under the Stark Act's whole hospital exception. The law contains a grandfather clause that allows previously created physician-owned hospitals to continue operating, but prevents the hospital from increasing the percent of physician ownership in such hospital.

Because the health care reform law is new and changes may occur in the future, providers impacted by these changes should continue to follow the health care reform debate.