Medicare and state health care programs and program fraud civil remedies: fraud and abuse; civil money penalties inflation adjustments--Office of Inspector General, HHS. Final rule

In accordance with Federal Civil Monetary Penalty Inflation Adjustment Act of 1990, as amended by the Debt Collection Improvement Act of 1996, this final rule incorporates the penalty inflation adjustments for the civil money penalties for health case fraud and abuse. These inflation adjustment calculations are not applicable to those civil money penalties contained in the Social Security Act, which are exempted from this adjustment.     

Medicare and state health care programs: fraud and abuse; safe harbors for protecting health plans--HHS. Interim final rule with request for comment

In accordance with section 14 of the Medicare and Medicaid Patient and Program Protection Act of 1987, this interim final rule establishes two new safe harbors and amends one existing safe harbor to provide protection for certain health care plans, such as health maintenance organizations and preferred provider organizations. The first new provision protects certain incentives to enrollees (including waiver of coinsurance and deductible amounts) paid by health care plans. The second new provision protects certain negotiated price reduction agreements between health care plans and contract health care providers. Finally, an existing safe harbor has been amended to protect certain agreements entered into between hospitals and Medicare SELECT insurers. These safe harbors specifically set forth various standards and guidelines that, if met, will result in the particular arrangement being protected from criminal prosecution or civil sanctions under the anti-kickback provisions of the statute.     

Office of Inspector General; Medicare and state health care programs: fraud and abuse; issuance of advisory opinions by the OIG. Final rule

OIG is adopting in final form, without change, an interim final rule published on March 26, 2008 (73 FR 15937). We received no comments to the interim final rule. The interim final rule revised the process for advisory opinion requestors to submit payments for advisory opinion costs.     

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.     

Medicare and State health care programs: fraud and abuse; OIG anti-kickback provisions--HHS. Final rule

This final rule implements section 14 of Public Law 100-93, the Medicare and Medicaid Patient and Program Protection Act of 1987, by specifying various payment practices which, although potentially capable of inducing referrals of business under Medicare or a State health care program, will be protected from criminal prosecution or civil sanctions under the anti-kickback provisions of the statute.     

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 programs: fraud and abuse; issuance of advisory opinions by the OIG--HHS. Final rule

In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996, this final rule sets forth the specific procedures by which the Department, through the Office of the Inspector General (OIG), in consultation with the Department of Justice (DoJ), will issue advisory opinions to outside parties regarding the interpretation and applicability of certain statutes relating to the Federal and State health care programs. The procedures for submitting a request and obtaining an advisory opinion from the OIG were established through interim final regulations published in the Federal Register on February 19, 1997. In response to public comments received on these interim final regulations, this final rule revises and clarifies various aspects of the earlier rulemaking.     

Special report on reimbursement. Final Medicare fraud and abuse safe harbors are published

There has been great concern in the health care industry that business arrangements that do not comply with the Safe Harbors will automatically be deemed illegal. HHS has confirmed that this is not so; the commentary to the Regulations expressly states that "The failure of a particular business arrangement to comply with these provisions does not determine whether or not the arrangement violates the statute because...this regulation does not make conduct illegal. Any conduct that could be construed to be illegal after the promulgation of this rule would have been illegal at any time since the current law was enacted in 1977....This regulation is intended to provide a formula for avoiding risk in the future." 56 Fed. Reg. at 35955. In the final analysis, the majority of transactions will fall outside the Safe Harbors and thus will continue to be judged by the standards established by the Medicare antifraud statute enacted 14 years ago. Under these standards, as HHS states, "the degree of the risk [in any particular transaction] depends on an evaluation of the many factors which are part of the decision-making process regarding case selection for investigation and prosecution." Id. at 35954. Providers that are mindful of these criteria should therefore still be able to accomplish, with relative safety, transactions that do not qualify for Safe Harbor protection.     

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.     

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; amendments to OIG exclusion and CMP authorities resulting from Public Law 100-93-- Office of Inspector General, HHS. Final rule and clarification

This final rule clarifies the scope and purpose of the exclusion authority provisions originally set forth in final rulemaking published in the Federal Register on January 29, 1992 (57 FR 3298). That final rule implemented the OIG sanction and civil money penalty (CMP) provisions established through section 2 and other conforming amendments in the Medicare and Medicaid Patient and Program Protection Act of 1987, and other statutory authorities. This clarifying document modifies the final rule to give greater clarity to the original scope of the authorities contained in 42 CFR part 1001. In addition, this rule is providing further clarification to the discovery provision set forth in part 1005 of the regulations.     

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.     

Medicare and state health care programs: fraud and abuse, civil money penalties and intermediate sanctions for certain violations by health maintenance organizations and competitive medical plans--HHS. Final rule

This final rule implements sections 9312(c)(2), 9312(f), and 9434(b) of Public Law 99-509, section 7 of Public Law 100-93, section 4014 of Public Law 100-203, sections 224 and 411(k)(12) of Public Law 100-360, and section 6411(d)(3) of Public Law 101-239. These provisions broaden the Secretary's authority to impose intermediate sanctions and civil money penalties on health maintenance organizations (HMOs), competitive medical plans, and other prepaid health plans contracting under Medicare or Medicaid that (1) substantially fail to provide an enrolled individual with required medically necessary items and services; (2) engage in certain marketing, enrollment, reporting, or claims payment abuses; or (3) in the case of Medicare risk-contracting plans, employ or contract with, either directly or indirectly, an individual or entity excluded from participation in Medicare. The provisions also condition Federal financial participation in certain State payments on the State's exclusion of certain prohibited entities from participation in HMO contracts and waiver programs. This final rule is intended to significantly enhance the protections for Medicare beneficiaries and Medicaid recipients enrolled in a HMO, competitive medical plan, or other contracting organization under titles XVIII and XIX of the Social Security Act.     

Health care programs: fraud and abuse; revisions to the PRO sanctions process--HHS. Final rule

This final rule revises and updates the procedures governing the imposition and adjudication of program sanctions predicted on recommendations of State Utilization and Quality Control Peer Review Organizations (PROs). These changes are being made as a result of statutory revisions designed to address health care fraud and abuse issues and the OIG sanctions process. In addition, this final rule sets forth new appeal and reinstatement procedures for practitioners and other persons excluded by the OIG based on a PRO recommendation.     

Medicare and state health care programs: fraud and abuse; issuance of advisory opinions by the OIG--HHS. Interim final rule with comment period

In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996, this final rule establishes a new part 1008 in 42 CFR chapter V to address the new OIG advisory opinion process. Specifically, these regulations set forth the specific procedures by which the Office of Inspector General, in consultation with the Department of Justice, will issue advisory opinions to outside parties regarding the interpretation and applicability of certain statutes relating to the Medicare and State health care programs.