Privacy Act; implementation. Office of Inspector General (OIG), HHS. Final rule

This final rule exempts the new system of records, the Healthcare Integrity and Protection Data Bank (HIPDB), from certain provisions of the Privacy Act (5 U.S.C. 552a). The establishment of the HIPDB is required by section 1128E of the Social Security Act (the Act), as added by section 221(a) of the Health Insurance Portability and Accountability Act (HIPAA) of 1996. Section 1128E of the Act directed the Secretary to establish a national health care fraud and abuse data collection program for the reporting and disclosing of certain final adverse actions taken against health care providers, suppliers or practitioners, and to maintain a data base of final adverse actions taken against health care providers, suppliers and practitioners. Regulations implementing the new HIPDB were published in the Federal Register on October 26, 1999 (64 FR 57740). The exemption being set forth in this rule applies to investigative materials compiled for law enforcement purposes.     

Health care fraud and abuse data collection program: reporting of final adverse actions--Office of Inspector General (OIG), HHS. Notice of proposed rulemaking

This proposed rule would establish a new 45 CFR part 61 to implement the statutory requirements of section 1128E of the Social Security Act, as added by section 221(a) of the Health Insurance Portability and Accountability Act (HIPAA) of 1996. Section 221(a) of HIPAA specifically directed the Secretary to establish a national health care fraud and abuse data collection program for the reporting and disclosing of certain final adverse actions taken against health care providers, suppliers, or practitioners, and maintain a data base of final adverse actions taken against health care providers, suppliers and practitioners.     

Office of Inspector General; Medicare program; prospective payment system for hospital outpatient services. Health Care Financing Administration (HCFA), HHS, and Office of Inspector General (OIG), HHS. Final rule with comment period

This final rule with comment period implements a prospective payment system for hospital outpatient services furnished to Medicare beneficiaries, as set forth in section 1833(t) of the Social Security Act. It also establishes requirements for provider departments and provider-based entities, and it implements section 9343(c) of the Omnibus Budget Reconciliation Act of 1986, which prohibits Medicare payment for nonphysician services furnished to a hospital outpatient by a provider or supplier other than a hospital, unless the services are furnished under an arrangement with the hospital. In addition, this rule establishes in regulations the extension of reductions in payment for costs of hospital outpatient services required by section 4522 of the Balanced Budget Act of 1997, as amended by section 201(k) of the Balanced Budget Refinement Act of 1999.     

Health care programs: fraud and abuse; revised OIG civil money penalties resulting from the Health Insurance Portability and Accountability Act of 1996--Office of Inspector General (OIG), HHS. Notice of proposed rulemaking

This proposed rule would revise the OIG's civil money penalty (CMP) authorities, in conjunction with new and revised provisions set forth in the Health Insurance Portability and Accountability Act of 1996. Among other provisions, this proposed rulemaking would codify new CMPs for: Excluded individuals retaining ownership or control interest in an entity; upcoding and claims for medically unnecessary services; offering inducements to beneficiaries; and false certification of eligibility for home health services. This rule would also codify a number of technical and conforming changes consistent with the OIG's existing sanction authorities.     

Health care fraud and abuse data collection program: reporting of final adverse actions. Office of Inspector General (OIG), HHS. Final rule

This final rule establishes a new CFR part to implement the statutory requirements of section 1128E of the Social Security Act, as added by section 221(a) of the Health Insurance Portability and Accountability Act (HIPAA) of 1996. Section 221(a) of HIPAA specifically directs the Secretary to establish a national health care fraud and abuse data collection program for the reporting and disclosing of certain final adverse actions taken against health care providers, suppliers and practitioners, and to maintain a data base of final adverse actions taken against health care providers, suppliers and practitioners.     

Health care programs: fraud and abuse; revised OIG civil money penalties resulting from public law 104-191. Office of Inspector General (OIG), HHS. Final rule

This final rule revises the OIG's civil money penalty (CMP) authorities, in conjunction with new and revised provisions set forth in the Health Insurance Portability and Accountability Act of 1996. Among other provisions, this final rulemaking codifies new CMPs for excluded individuals retaining ownership or control interest in an entity; upcoding and claims for medically unnecessary services; offering inducements to beneficiaries; and false certification of eligibility for home health services. This rule also codifies a number of technical corrections to the regulations governing OIG's sanction authorities.     

Publication of the OIG compliance program guidance for hospitals--OIG. Notice

This Federal Register notice sets forth the recently issued compliance program guidance for hospitals developed by the Office of Inspector General (OIG) in cooperation with, and with input from, several provider groups and industry representatives. Many providers and provider organizations have expressed an interest in better protecting their operations from fraud and abuse through the adoption of voluntary compliance programs. The first compliance guidance, addressing clinical laboratories, was prepared by the OIG and published in the Federal Register on March 3, 1997. We believe the development of this second program guidance, for hospitals, will continue as a positive step towards promoting a higher level of ethical and lawful conduct throughout the health care industry.     

Publication of the OIG model compliance plan for clinical laboratories--HHS. Notice

This Federal Register notice sets forth the recently issued model compliance plan for clinical laboratories developed by the Office of Inspector General in cooperation with, and input from, several provider groups and industry representatives. Many providers and provider organizations have expressed an interest in better protecting their operations from fraud through the adoption of compliance plans. We believe the development of this initial model compliance plan for clinical laboratories will serve as a positive step towards promoting a higher level of ethical and lawful conduct throughout the health care industry.     

Publication of OIG compliance program guidance for clinical laboratories--HHS. Notice

This Federal Register notice sets forth the OIG's recently-issued Compliance Program Guidance for Clinical Laboratories. The OIG had previously developed and published a model compliance plan for the clinical laboratory industry on March 3, 1997. This Compliance Program Guidance for Clinical Laboratories is intended to be more consistent with compliance program guidances issued by the OIG with respect to the hospital industry and to home health agencies, and serves to clarify various aspects of the original model plan. As with previously-issued compliance program guidances, we believe that the development of this guidance for clinical laboratories will continue as a positive step towards promoting a higher level of ethical and lawful conduct throughout the entire health care community.     

Publication of the OIG compliance program guidance for home health agencies--OIG. Notice

This Federal Register notice sets forth the recently issued Compliance Program Guidance for Home Health Agencies developed by the Office of Inspector General (OIG) in cooperation with, and with input from, several provider groups and industry representatives. Many home health care providers have expressed interest in better protecting their operations from fraud and abuse through the adoption of a voluntary compliance program. The OIG has previously developed and published compliance program guidances focused on the clinical laboratory and hospital industries (62 FR 9435, March 3, 1997 and 63 FR 8987, February 23, 1998, respectively). We believe that the development of this compliance program guidance for the home health industry will continue as a positive step towards promoting a higher level of ethical and lawful conduct throughout the entire health care community.     

Medicare and state health care programs: fraud and abuse; amendments to OIG exclusion and CMP authorities resulting from the Medicare and Medicaid Patient and Program Protection Act--Office of Inspector General (OIG), HHS. Final rule

This document amends a technical error that appeared in the final rule, which amends the OIG exclusion and CMP authorities, published on January 29, 1992 designed to implement section 2 of the Medicare and Medicaid Patient and Program Protection Act, along with other conforming amendments. The final rule is designed to protect program beneficiaries from unfit health care practitioners, and otherwise improve the anti-fraud provisions of the Department's Medicare and State health care programs.     

Medicare and state health care programs: fraud and abuse; clarification of the initial OIG safe harbor provisions and establishment of additional safe harbor provisions under the anti-kickback statute. Office of Inspector General (OIG), HHS. Final rule

This final rule serves both to add new safe harbor provisions under the Federal and State health care programs' anti-kickback statute, as authorized under section 14 of Public Law 100-93, the Medicare and Medicaid Patient and Program Protection Act of 1987, and to clarify various aspects of the original safe harbor provisions now codified in 42 CFR part 1001 (originally proposed in RIN 0991-AA74). Specifically, this final rule modifies the original set of final safe harbor provisions codified in 42 CFR 1001.952 to give greater clarity to that rulemaking's original intent. In addition, this final rule sets forth an expanded set of safe harbor provisions designed to protect additional payment and business practices from criminal prosecution or civil sanctions under the anti-kickback provisions of the statute.     

Health care programs: fraud and abuse; revised OIG exclusion authorities resulting from Public Law 104-191; correction--Office of Inspector General (OIG). HHS. Final rule; correcting amendment

This document contains corrections to the final regulations which were published in the Federal Register of Wednesday, September 2, 1998 (63 FR 46676). The regulations addressed revisions to the OIG's administrative sanction authorities resulting from the Health Insurance Portability and Accountability Act of 1996, along with technical and conforming changes to the OIG exclusion authorities. A number of inadvertent errors appeared in the text of the regulations relating to program integrity for the Medicare and State health care programs. As a result, we are making corrections to two sections addressing the length of exclusion and notice of intent to exclude in order to assure the technical correctness of these regulations.     

Solicitation of new safe harbors and special fraud alerts--Office of Inspector General, HHS. Notice of intent to develop regulations

In accordance with section 205 of the Health Insurance Portability and Accountability Act (HIPAA) of 1996, this notice solicits proposals and recommendations for developing new and modifying existing safe harbor provisions under the Federal and State health care programs' anti-kickback statute, as well as developing new OIG Special Fraud Alerts. The purpose of developing these documents is to clarify OIG enforcement policy with regard to program fraud and abuse.     

Criteria for implementing permissive exclusion authority under Section 1128(b)(7) of the Social Security Act--Office of Inspector General, HHS. Notice

This notice sets forth a proposed policy statement, in the form of non-binding guidelines, to be used by the OIG in assessing whether to impose a permissive exclusion in accordance with section 1128(b)(7) of the Social Security Act. These guidelines identify specific factors with regard to whether an individual's or entity's continued participation in the Medicare and other Federal and State health care programs will pose a risk to the programs or program beneficiaries, and explain how these factors would be used by the OIG to assess a permissive exclusion decision.     

Publication of OIG Special Fraud Alert: fraud and abuse in nursing home arrangements with hospices--OIG. Notice

This Federal Register notice sets forth a recently issued OIG Special Fraud Alert concerning fraud and abuse practices involving nursing home arrangements with hospices. For the most part, OIG Special Fraud Alerts address national trends in health care fraud, including potential violations of the Medicare anti-kickback statute. This Special Fraud Alert, issued to the health care provider community and now being reprinted in this issue of the Federal Register, specifically identifies and highlights some vulnerabilities in nursing home arrangements with hospices and instances of potential kickbacks between nursing homes and hospices to influence the referral of patients.     

Solicitation of information and recommendations for developing OIG compliance program guidance for certain Medicare+Choice organizations--OIG, HHS. Notice

This Federal Register notice seeks the input and recommendations of interested parties into the OIG's development of a compliance program guidance for Medicare+Choice organizations that offer coordinated care plans (M+CO/CCPs). The OIG has previously developed compliance program guidances for hospitals, clinical laboratories and home health agencies in order to provide clear and meaningful guidance to those segments of the health care industry. In an effort to provide similar guidance to certain M+C organizations, we are soliciting comments, recommendations and other suggestions from concerned parties and organizations on how best to develop compliance program guidance and reduce fraud and abuse within M+CO/CCPs.