# 61 FR 69060: Solicitation of New Safe Harbors and Modifications to Existing Safe Harbors > Federal · Regulations · In force URL: https://www.frixlaw.com/law-library/statutes/FR_PRORULE_96-33277 ## Section - **Citation:** 61 FR 69060 - **Heading:** Solicitation of New Safe Harbors and Modifications to Existing Safe Harbors - **Jurisdiction:** Federal - **Kind:** Regulations - **Status:** In force - **Text as of:** August 14, 2026 - **Source:** Compiled text - **Location:** Federal Register / Vol. 61 / 61 FR 69060 ## Text DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of Inspector General 42 CFR Part 1001 Solicitation of New Safe Harbors and Modifications to Existing Safe Harbors AGENCY: Office of Inspector General (OIG), HHS. ACTION: Notice of intent to develop regulations. ----------------------------------------------------------------------- SUMMARY: In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996, this notice solicits proposals and recommendations for developing new and modifying existing safe harbor provisions under the Medicare and State health care programs' anti-kickback statute, as well as developing new OIG Special Fraud Alerts. DATES: To assure consideration, public comments must be delivered to the address provided below by no later than 5 p.m. on March 3, 1997. ADDRESSES: Please mail or deliver your written comments to the following address: Office of Inspector General, Department of Health and Human Services, Attention: OIG-11-N, Room 5246, Cohen Building, 330 Independence Avenue, S.W. Washington, DC 20201. Because of staffing and resource limitations, we cannot accept comments by facsimile (FAX) transmission. In commencing, please refer to file code OIG-11-N. Comments received timely will be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, in Room 5541 of the Office of Inspector General at 330 Independence Avenue, S.W., Washington, D.C., on Monday through Friday of each week from 8:00 a.m. to 4:30 p.m. FOR FURTHER INFORMATION CONTACT: Joel Schaer, (202) 619-0089, OIG Regulations Officer. SUPPLEMENTARY INFORMATION: I. Background A. The OIG Safe Harbor Provisions ginning approximately 3 weeks after publication of a document, in Room 5541 of the Office of Inspector General at 330 Independence Avenue, S.W., Washington, D.C., on Monday through Friday of each week from 8:00 a.m. to 4:30 p.m. FOR FURTHER INFORMATION CONTACT: Joel Schaer, (202) 619-0089, OIG Regulations Officer. SUPPLEMENTARY INFORMATION: I. Background A. The OIG Safe Harbor Provisions Section 1128B(b) of the Social Security Act (42 U.S.C. 1320a-7b(b)) provides criminal penalties for individuals or entities that knowingly and willfully offer, pay, solicit or relieve remuneration in order to induce business reimbursed under the Medicare or State health care programs. The offense is classified as a felony, and is punishable by fines of up to $25,000 and imprisonment for up to 5 years. The types of remuneration covered specifically include kickbacks, bribes, and rebates, whether made directly or indirectly, overtly or covertly, or in cash or in kind. In addition, prohibited conduct includes not only remuneration intended to induce referrals of patients, but remuneration intended to induce the purchasing, leasing, ordering, or arranging for any good, facility, service, or item paid for by Medicare or State health care programs. Since the statute on its face is so broad, concern has been expressed for many years that some relatively innocuous commercial arrangements are technically covered by the statute and are, therefore, subject to criminal prosecution ion intended to induce the purchasing, leasing, ordering, or arranging for any good, facility, service, or item paid for by Medicare or State health care programs. Since the statute on its face is so broad, concern has been expressed for many years that some relatively innocuous commercial arrangements are technically covered by the statute and are, therefore, subject to criminal prosecution. As a response to the above concern, the Medicare and Medicaid Patient and Program Protection Act of 1987, section 14 of Public Law 100-93, specifically required the development and promulgation of regulations, the so-called ``safe harbor'' provisions, designed to specify various payment and business practices which, although potentially capable of inducing referrals of business under the Medicare and State health care programs, would not be treated as criminal offenses under the anti-kickback statute (section 1128B(b) of the Social Security Act; 42 U.S.C. 1320a-7b(b)) and would not serve as a basis for a program exclusion under section 1128(b)(7) of the Social Security Act; 42 U.S.C. 1320a-7(b)(7). The OIG safe harbor provisions have been developed ``to limit the reach of the statute somewhat by permitting certain non-abusive arrangements, while encouraging beneficial and innocuous arrangements'' (56 FR 35952, July 29, 1991). Health care providers and others may voluntarily seek to comply with these provisions so that they have the assurance that their business practices are not subject to any enforcement action under the anti-kickback statute or program exclusion authority. To date, the OIG has developed and codified in 42 CFR 1001.952 a total of 13 final safe harbors that describe practices that are sheltered from liability, and is continuing to finalize 8 additional safe harbor provisions (see the OIG notice of proposed rulemaking at 58 FR 49008, September 21, 1993). B. OIG Special Fraud Alerts under the anti-kickback statute or program exclusion authority. To date, the OIG has developed and codified in 42 CFR 1001.952 a total of 13 final safe harbors that describe practices that are sheltered from liability, and is continuing to finalize 8 additional safe harbor provisions (see the OIG notice of proposed rulemaking at 58 FR 49008, September 21, 1993). B. OIG Special Fraud Alerts In addition, the OIG has also periodically issued Special Fraud Alerts to give continuing guidance to health care providers with respect to practices the OIG regards as unlawful. These Special Fraud Alerts provide the OIG with a means of notifying the health care industry that we have become aware of certain abusive practices which we plan to pursue and prosecute, or bring civil and administrative action, as appropriate. The Special Fraud Alerts also serve as a tool to encourage industry compliance by giving providers an opportunity to examine their own practices. The OIG Special Fraud Alerts are intended for extensive distribution directly to the health care provider community, as well as those charged with administering the Medicare and Medicaid programs. In developing these Special Fraud Alerts, the OIG has relied on a number of sources and has consulted directly with experts in the subject field, including those within the OIG, other agencies of the Department, other Federal and State agencies, and from those in the health care industry. To date, eight individual Special Fraud Alerts have been issued by the OIG and subsequently reprinted in the Federal Register on December 19, 1994 (59 FR 65372), August 10, 1995 (60 FR 40847) and June 17, 1996 (61 FR 30623) II. Section 205 of Public Law 104-191 ly, in accordance with the statute, the OIG will formally begin accepting requests for advisory opinions on February 21, 1997. Regulations establishing the procedures and a process for accepting and issuing advisory opinions are being prepared for separate publication in the Federal Register and will be issued in the near future. Criteria for Modifying and Establishing Safe Harbor Provisions In accordance with the statute, we will consider a number of factors in considering proposals for new or modified safe harbor provisions, such as the extent to which the proposals would affect an increase or decrease in-- Access to health care services; The quality of health care services; Patient freedom of choice among health care providers; Competition among health care providers; The cost to Federal health care programs; The potential overutilization of the health care services; and The ability of health care facilities to provide services in medically underserved areas or to medically underserved populations. In addition, we will also take into consideration the existence (or nonexistence) of any potential financial benefit to a health care professional or provider that may vary based on their decisions of whether to (1) order a health care item or service, or (2) arrange for a referral of health care items or services to a particular practitioner or provider. Criteria for Developing Special Fraud Alerts In determining whether to issue additional Special Fraud Alerts, we will also consider whether, and to what extent, those practices that would be identified in new Fraud Alerts may result in any of the consequences set forth above, and the volume and frequency of the conduct that would be identified in these Special Fraud Alerts. III. Solicitation of Public Comments ing Special Fraud Alerts In determining whether to issue additional Special Fraud Alerts, we will also consider whether, and to what extent, those practices that would be identified in new Fraud Alerts may result in any of the consequences set forth above, and the volume and frequency of the conduct that would be identified in these Special Fraud Alerts. III. Solicitation of Public Comments In order to address the requirements of section 205 of Public Law 104-191, we are requesting public comments from affected provider, practitioner, supplier and beneficiary representatives regarding the development of proposed or modified safe harbor regulations and new Special Fraud Alerts. A detailed explanation of justification or empirical data supporting the suggestion would prove helpful in our considering and drafting new or modified safe harbor regulations and Special Fraud Alerts. Dated: December 20, 1996. June Gibbs Brown, Inspector General, Department of Health and Human Services. Approved: December 20, 1996. Donna E. Shalala, Secretary. [FR Doc. 96-33277 Filed 12-30-96; 8:45 am] BILLING CODE 4150-04-M ## Nearby sections - [61 FR 33 St. Marys Falls Canal and Locks, Michigan; Use, Administration, and Navigation](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_95-31543.md) - [61 FR 295 Public Workshop on the Regulation of Radioactive Devices](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_96-108.md) - [61 FR 552 Retirement Bonds](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_96-165.md) - [61 FR 705 Promoting Wholesale Competition Through Open Access Nondiscriminatory Transmission Services by Public Utilities; Recovery of Stranded Costs by Public Utilities and Transmitting Utilities; Notice of Technical Conference and Potential Broadcast of Technical Conference Concerning Independent System Operators and Reform of Power Pools Under the Federal Power Act](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_96-340.md) - [61 FR 1162 Lending and Investment](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_96-409.md) - [61 FR 1306 Airworthiness Directives; Transport Category Airplanes](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_96-493.md) - [61 FR 1528 Airworthiness Directives; Airbus Model A300 Series Airplanes (Excluding Model A300 B4-600 Series Airplanes)](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_96-590.md) - [61 FR 1545 Procedures For The Issuance, Denial, And Revocation Of Certificates Of Label Approval, Certificates Of Exemption From Label Approval, And Distinctive Liquor Bottle Approvals (93F-029P)](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_96-575.md) - [61 FR 1546 Indiana Regulatory Program](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_96-646.md) - [61 FR 1546 Appropriateness of Requested Single Location Bargaining Units in Representation Cases](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_96-741.md) - [61 FR 1551 Indiana Regulatory Program](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_96-648.md) - [61 FR 1870 Proposed Revision of Class E Airspace; Belen, NM](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_96-1004.md) - [61 FR 1873 Proposed Revision of Class E Airspace; Marshall, TX](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_96-1007.md) - [61 FR 1889 Defense Federal Acquisition Regulation Supplement; Finance](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_96-973.md) --- Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/FR_PRORULE_96-33277. Check the current official text before relying on it. Not legal advice.