PUBLIC LAW 104-191—AUG. 21, 1996 110 STAT. 2001 General, shall publish in the Federal Register proposed modifications to existing safe harbors and proposed additional safe harbors, if appropriate, with a 60-day comment period. After considering any public comments received during this period, the Secretary shall issue final rules modifying the existing safe harbors and establishing new safe harbors, as appropriate. "(C) REPORT.— The Inspector General of the Department of Health and Human Services (in this section referred to as the 'Inspector General') shall, in an annual report to Congre;ss or as part of the year-end semisinnual report required by section 5 of the Inspector General Act of 1978 (5 U.S.C. App.), describe the proposals received under clauses (i) and (ii) of subparagraph (A) and explain which proposals were included in the publication described in subparagraph (B), which proposals were not included in that publication, and the reasons for the rejection of the proposals that were not included. "(2) CRITERIA FOR MODIFYING AND ESTABLISHING SAFE HAR- BORS.— In modifying and establishing safe harbors under paragraph (1)(B), the Secretary may consider the extent to which providing a safe harbor for the specified payment practice may result in any of the following: "(A) An increase or decrease in access to health care services. "(B) An increase or decrease in the quality of health care services. "(C) An increase or decrease in patient fireedom of choice among health care providers. "(D) An increase or decrease in competition among health care providers. "(E) An increase or decrease in the ability of health care facilities to provide services in medically underserved areas or to medically underserved populations. "(F) An increase or decrease in the cost to Federal health care programs (as defined in section 1128B(f)). "(G) An increase or decrease in the potential overutilization of health care services. "(H) The existence or nonexistence of any potential financial benefit to a health care professional or provider which may vary based on their decisions of— "(i) whether to order a health care item or service; or "(ii) whether to arrange for a referral of health care items or services to a particular practitioner or provider. "(I) Any other factors the Secretary deems appropriate in the interest of preventing fraud and abuse in Federal health care programs (as so defined). " (b) ADVISORY OPINIONS. — "(1) ISSUANCE OF ADVISORY OPINIONS.— The Secretary, in consultation with the Attorney General, shall issue written advisory opinions as provided in this subsection. "(2) MATTERS SUBJECT TO ADVISORY OPINIONS.— The Secretary shall issue advisory opinions as to the following matters: "(A) What constitutes prohibited remuneration within the meaning of section 1128B(b).
�
