Publication of OIG Special Fraud Alerts: home health fraud, and fraud and abuse in the provision of medical supplies to nursing facilities--HHS. Notice

This Federal Register notice sets forth two recently issued OIG Special Fraud Alerts concerning fraud and abuse practices in the home health industry and in the provision of medical supplies to nursing facilities. For the most part, the OIG Special Fraud Alerts address national trends in health care fraud, including potential violations of the Medicare anti-kickback statute. These two Special Fraud Alerts, issued directly to the health care provider community and now being reprinted in this issue of the Federal Register, specifically address fraud and abuse in the provision of (1) home health services and (2) medical supplies to nursing facilities, including the submission of false claims and anti-kickback violations.     

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.     

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.     

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 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.     

Solicitation of information and recommendations for developing OIG compliance program guidance for the durable medical equipment industry--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 the durable medical equipment (DME) industry, its providers and suppliers. Many providers and provider organizations have expressed an interest in better protecting their operations from fraud and abuse. Previously, the OIG has 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 involved in the supply and distribution of DME, 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 the DME industry.     

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.     

Publication of the OIG's provider self-disclosure protocol--Office of Inspector General (OIG), HHS. Notice

This Federal Register notice sets forth the OIG's recently-issued Provider Self-Disclosure Protocol. This Self-Disclosure Protocol offers health care providers specific steps, including a detailed audit methodology, that may be undertaken if they wish to work openly and cooperatively with the OIG to efficiently quantify a particular problem and, ultimately, promote 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.     

Solicitation of comments on the OIG/HCFA Special Advisory Bulletin on the patient anti-dumping statute--OIG and HCFA. Notice of proposed special advisory bulletin

This Federal Register notice seeks the input and comments of interested parties on a Special Advisory Bulletin being developed by the OIG and HCFA designed to address requirements of the patient anti-dumping statute and the obligations of hospitals to screen all patients seeking emergency services and provide stabilizing medical treatment to enrollees of managed care plans if their condition warrants it. In developing this proposed issuance and soliciting public comment, it is our goal to provide clear and meaningful advice with regard to the application of the anti-dumping provisions, and ensure greater public awareness of the hospitals' obligations in providing emergency medical services to those individuals insured by managed care plans.     

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.     

Health care programs: fraud and abuse; revised OIG exclusion authorities resulting from Public Law 104-191--OIG. Final rule

This final rule addresses revisions to the OIG's administrative sanction authorities to comport with sections 211, 212 and 213 of the Health Insurance Portability and Accountability Act (HIPAA) of 1996, along with other technical and conforming changes to the OIG exclusion authorities set forth in 42 CFR parts 1000, 1001, 1002 and 1005. These revisions serve to expand the scope of certain basic fraud authorities, and revise and strengthen the current legal authorities pertaining to exclusions from the Medicare, Medicaid and all other Federal health care programs.     

Home health agencies: targets of anti-fraud and abuse investigations

Increased health care fraud and abuse investigations could result in home health agencies, and other targets, becoming politically acceptable casualties of war in the battle to balance the federal budget. To protect themselves, home health agencies would be well advised to conduct internal fraud and abuse audits on an annual basis and to develop corporate compliance plans (see Newsletter, Vol. 9, No. 7, July 1994, at 16, and next month's issue, which will discuss corporate compliance programs as well as the OIG's new voluntary disclosure program). In addition, purchasers of home health agencies should be especially vigilant of fraud and abuse problems during the due diligence phase of the acquisition and, if problems are discovered, should consider whether voluntary disclosure to the OIG and settlement of any resulting claims is an appropriate condition of closing.     

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.     

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.     

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.     

Recovering fraudulent claims for Australian federal expenditure on pharmaceuticals and medical devices

The Australian Federal Government expends increasingly large amounts of money on pharmaceuticals and medical devices. It is likely, given government experience in other jurisdictions, that a significant proportion of this expenditure is paid as a result of fraudulent claims presented by corporations. In the United States, legislation such as the False Claims Act 1986 (US), the Fraud Enforcement and Recovery Act 2009 (US), the Stark (Physician Self-Referral) Statute 1995 (US), the Anti-Kickback Statute 1972 (US), the Food, Drug and Cosmetic Act 1938 (US), the Social Security Act 1965 (US), and the Patient Protection and Affordable Care Act 2010 (US) has created systematic processes allowing the United States Federal Government to recover billions of dollars in fraudulently made claims in the health and procurement areas. The crucial component involves the creation of financial incentives for information about fraud to be revealed from within the corporate sector to the appropriate state officials. This article explores the opportunities for creating a similar system in Australia in the health care setting.     

Health care programs: fraud and abuse; revised OIG exclusion authorities resulting from Public Law 104-191--HHS. Notice of proposed rulemaking

This rulemaking addresses proposed revisions to the OIG's sanction authorities in conjunction with sections 211, 212 and 213 of the Health Insurance Portability and Accountability Act of 1996, along with other technical and conforming changes to the OIG exclusion authorities set forth in 42 CFR parts 1000, 1001, 1002 and 1005. These proposed revisions are specifically designed to expand the protection of certain basic fraud authorities, and revise and strengthen the current legal authorities pertaining to exclusions from the Medicare and State health care programs.     

Health care programs: fraud and abuse; technical revision to the scope and effect of the OIG exclusion regulations--HHS. Final rule

This document sets forth a technical revision to OIG regulations on program integrity for Medicare and State Health Care programs, concerning the scope and effect of the OIG's program exclusion regulations. Prior to this revision, the regulations provided that a program exclusion imposed under title XI of the Social Security Act was to affect future participation in all Federal non-procurement programs. This revision specifically amends the language in the existing regulations to clarify that the scope of an exclusion is now applicable to all Executive Branch procurement and non-procurement programs and activities. This rule is consistent with the Federal Acquisition Streamlining Act, and the Department's Common Rule on debarment and suspension which is also being amended and published elsewhere in this issue of the Federal Register.     

Health Care Financing Administration--Adoption of the National Bureau of Standards fire safety evaluation system for health care facilities. Final notice

The Department of Health, Education, and Welfare proposed extending the new Fire Safety Evaluation sSystem (FSES) to all hospitals participating in the Medicare and Medicaid programs in a Notice of comment period publishedon June 28, 1979 in the Federal Register (44 FR 37818). The Department also sought public comment on whether to apply the FSES to skilled nursing facilities (SNFs) and intermediate care facilities (ICFs) in this same Notice. After a careful review and analysis of the public comments received, the Department has decided to adopt the FSES as a means of evaluating alternative arrangements used to achieve compliance with the provisions of the Life Safety Code for hospitals, skilled nursing facilities, and intermediate care facilities participating in the Medicare and Medicaid programs.