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.     

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 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.     

Pharma on the hot seat

The pharmaceutical industry has been receiving greater scrutiny lately due in large part to the many public and private legal enforcement actions taken against pharmaceutical manufacturers. These enforcement actions, along with legal developments such as the OIG Compliance Guidance for Pharmaceutical Manufacturers, the Sarbanes-Oxley Act's statutory guidelines for public corporations, the HIPAA privacy regulations, and the Medicare Modernization Act, have the potential to encourage the pharmaceutical industry to self-regulate beyond the bounds currently required by the law. After a brief overview of enforcement actions and compliance programs directed toward the pharmaceutical industry, this Article reviews a similar situation the hospital industry faced when Medicare promulgated major reimbursement modifications. The Article proposes that the pharmaceutical industry, in the face of such intense scrutiny and uncertainty, should implement more rigorous self-regulation. Without more stringent self-regulation, this intense interest in the pharmaceutical industry may result in a regulatory push that establishes unanticipated and cumbersome measures for the 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.     

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.     

Health care programs: fraud and abuse; amendments to OIG exclusion and CMP authorities resulting from Public Law 100-93--HHS. Final rule

This final rule implements the OIG sanction and civil money penalty provisions established through section 2 and other conforming amendments in the Medicare and Medicaid Patient and Program Protection Act of 1987, along with certain additional provisions contained in the Consolidated Omnibus Budget Reconciliation Act of 1985, the Omnibus Budget Reconciliation Act (OBRA) of 1987, the Medicare Catastrophic Coverage Act of 1988, OBRA of 1989, and OBRA of 1990. Specifically, these regulations are designed to protect program beneficiaries from unfit health care practitioners, and otherwise to improve the anti-fraud provisions of the Department's health care programs under titles V, XVIII, XIX and XX of the Social Security Act.     

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.     

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.     

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.     

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 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.     

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.     

Medicare, Medicaid and CLIA programs; revision of the laboratory regulations for the Medicare, Medicaid, and Clinical Laboratories Improvement Act of 1967 programs--HCFA. Final rule with comment period

This rule revises regulations for laboratories regulated under the Medicare, Medicaid and Clinical Laboratories Improvement Act of 1967 (CLIA '67) programs. The revisions recodify the regulations for these programs into a new part 493 in order to simplify administration and unify the health and safety requirements for all programs as much as possible. We will now have a single set of regulations for the three programs, with an additional subpart for the licensure procedures unique to the CLIA program. We are revising the regulations to remove outdated, obsolete and redundant requirements, make provision for new technologies and place increased reliance on outcome measures of performance. We provide for new uniform proficiency testing standards. We have also added requirements for additional specialties, such as clinical cytogenetics. We also implement the now and self-implementing provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88).     

Examining exclusionary conduct of HMOs and PPOs: a case comment on Northwest Medical Laboratories v. Blue Cross and Blue Shield of Oregon.

As the climate of the health care industry has changed to one of cost-containment and competition through the growth of HMOs and PPOs, health care providers have become the subjects of antitrust litigation. One such case, Northwest Medical Laboratories v. Blue Cross and Blue Shield of Oregon, involved a medical laboratory and a radiology center who claimed that they were victims of an illegal group boycott after defendant's pre-paid health plan denied them preferred provider status. The Oregon Court of Appeals, using the traditional antitrust analysis applied to other industries for decades, failed to consider the intricacies that exist within the health care industry. This result led to an inaccurate market share computation and an inadequate rule of reason analysis. This Comment examines the shortcomings of the Northwest Medical opinion and argues that, in applying the antitrust laws to the health care industry, courts in future cases must recognize and respect the unique features of the business of providing health care.     

Making sense of HIPAA Privacy: solutions for complex compliance dilemmas

This Article examines and proposes solutions for the following compliance problems under the Health Information Portability and Accountability Act's Privacy Rule: (a) determining compliance requirements when multiple provisions of the Privacy Rule allow a use or disclosure of protected health information; (b) managing minimum necessary for disclosures to noncovered entities; (c) managing interaction between organized healthcare arrangements and noncovered providers; (d) processing joint health and life/disability insurance applications; (e) reconciling family coverage explanations of benefits and family member's confidential communication demands; and (f) explaining denial of protected health information access based on endangerment. In the course of the analysis, the Article presents a Privacy Rule Compliance Tool that summarizes the compliance requirements associated with each Privacy Rule provision that allows protected health information use or disclosure.     

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.     

State child health; implementing regulations for the State Children's Health Insurance Program. Health Care Financing Administration (HCFA), HHS. Final rule

Section 4901 of the Balanced Budget Act of 1997 (BBA) amended the Social Security Act (the Act) by adding a new title XXI, the State Children's Health Insurance Program (SCHIP). Title XXI provides funds to States to enable them to initiate and expand the provision of child health assistance to uninsured, low-income children in an effective and efficient manner. To be eligible for funds under this program, States must submit a State plan, which must be approved by the Secretary. This final rule implements provisions related to SCHIP including State plan requirements and plan administration, coverage and benefits, eligibility and enrollment, enrollee financial responsibility, strategic planning, substitution of coverage, program integrity, certain allowable waivers, and applicant and enrollee protections. This final rule also implements the provisions of sections 4911 and 4912 of the BBA, which amended title XIX of the Act to expand State options for coverage of children under the Medicaid program. In addition, this final rule makes technical corrections to subparts B, and F of part 457.     

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.