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.     

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, Medicaid, and Children's Health Insurance Programs; additional screening requirements, application fees, temporary enrollment moratoria, payment suspensions and compliance plans for providers and suppliers. Final rule with comment period

This final rule with comment period will implement provisions of the ACA that establish: Procedures under which screening is conducted for providers of medical or other services and suppliers in the Medicare program, providers in the Medicaid program, and providers in the Children's Health Insurance Program (CHIP); an application fee imposed on institutional providers and suppliers; temporary moratoria that may be imposed if necessary to prevent or combat fraud, waste, and abuse under the Medicare and Medicaid programs, and CHIP; guidance for States regarding termination of providers from Medicaid and CHIP if terminated by Medicare or another Medicaid State plan or CHIP; guidance regarding the termination of providers and suppliers from Medicare if terminated by a Medicaid State agency; and requirements for suspension of payments pending credible allegations of fraud in the Medicare and Medicaid programs. This final rule with comment period also discusses our earlier solicitation of comments regarding provisions of the ACA that require providers of medical or other items or services or suppliers within a particular industry sector or category to establish compliance programs. We have identified specific provisions surrounding our implementation of fingerprinting for certain providers and suppliers for which we may make changes if warranted by the public comments received. We expect to publish our response to those comments, including any possible changes to the rule made as a result of them, as soon as possible following the end of the comment period. Furthermore, we clarify that we are finalizing the adoption of fingerprinting pursuant to the terms and conditions set forth herein.     

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.     

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 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 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.     

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 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.     

Privacy Act of 1974; report of altered systems--HCFA. Notice of the global addition of three new routine uses to designated HCFA systems of records

HCFA is adding three additional routine uses to the Systems of Records specified in Appendix A. These routine uses will permit HCFA to disclose individual-specific information for the purpose of combating fraud or abuse in the health benefit programs administered by HCFA and for other compatible purposes. These new routine uses will permit HCFA to make disclosures as follows: (1) To a HCFA contractor, including but not necessarily limited to fiscal intermediaries and carriers under title XVIII of the Social Security Act, to administer some aspect of a HCFA-administered health benefits program, or to a grantee of a HCFA-administered grant program, which program is or could be affected by fraud or abuse, for the purpose of preventing, deterring, discovering, detecting, investigating, examining, prosecuting, suing with respect to, defending against, correcting, remedying, or otherwise combating such fraud or abuse in such program; (2) To another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States, including any state or local government agency, for the purpose of preventing, deterring, discovering, detecting, investigating, examining, prosecuting, suing with respect to, defending against, correcting, remedying, or otherwise combating fraud or abuse in a health benefits program funded in whole or in part by Federal funds; and, (3) To any entity that makes payment for or oversees the administration of health care services, for the purpose of preventing, deterring, discovering, detecting, investigating, examining, prosecuting, suing with respect to, defending against, correcting, remedying, or otherwise combating fraud or abuse against such entity or the program or services administered by such entity, subject to certain conditions.     

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.     

Corporate compliance and voluntary disclosure

In any event, the decision to institute a corporate compliance program is a relatively simple one. In view of the ambiguity surrounding certain fraud and abuse provisions, and the corporate "death sentence" that may result from program exclusion, a compliance program is always sound corporate policy. To be sure, if the compliance program is administered improperly, it can actually increase the likelihood of whistleblower actions and create a body of potentially hurtful documentation. But these dangers can be minimized by structuring the program to protect the self-evaluative process through relevant privileges. The risks also pale in comparison to the exposure to criminal or exclusionary sanctions when improper conduct goes undetected by an organization.     

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.     

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.     

We've had training, now what? Qualitative analysis of barriers to domestic violence screening and referral in a health care setting

The present study assesses barriers to identification and referral of domestic violence (DV) victims by staff at a health care institution following a 3-hr DV training program in which 752 health care providers participated. Focus groups are conducted with staff in hospital departments that serve a high volume of women. Responses to focus group questions identify system-wide and individual hospital department barriers. These barriers have implications for health care organizations trying to implement DV screening protocols through training alone to change staff behavior in diverse clinical settings. Limitations of this study and future research recommendations are also discussed.     

Control of fraud and abuse in Medicare and Medicaid.

This Comment explores issues concerning the control of fraud and abuse in health programs financed with public funds, specifically the Medicare and Medicaid programs. It summarizes the nature, scope, and possible causes of what some regard as a fraud and abuse "crisis," and points out the difficulties and obstacles facing those who attempt to develop legislative and executive action aimed at controlling fraud and abuse. Recent federal initiatives in fraud and abuse control are examined, and a brief summary of key provisions of H.R. 3 (the Medicare-Medicaid Anti-fraud and Abuse Amendments, which may prove to be a landmark piece of legislation in this area) is provided. The author emphasizes that more effective control of fraud and abuse is necessary if further expansion of government financing of health programs, including national health insurance, is to occur in the near future. At the same time, caution must be taken not to neglect the appropriate use of other mechanisms necessary for reducing the costs of medical care and improving its quality. In addition, it is likely that efforts to stem fraud and abuse will raise important medicolegal and public policy issues that will require careful interdisciplinary consideration.     

Qui tam claims: threat to voluntary compliance programs in health care organizations

The Department of Justice (DOJ) reports that after violent crime, health care fraud is the department's top priority. The number of health care fraud investigations pending at the DOJ increased from 270 cases in 1992 to more than 4,000 in 1997. The DOJ's primary weapon in prosecuting health care fraud is the federal False Claims Act (FCA) of 1863 (31 U.S.C. secs. 3729-3733). Almost unique among federal antifraud provisions, the FCA may also be used by "private prosecutors" to file lawsuits on behalf of the federal government charging organizations with submitting false claims to the government. The FCA rewards such whistle-blowers with a share of any resulting recoveries as a bounty and protects them from discharge for filing false claims lawsuits against their employers. It also requires defendants to pay the costs and attorneys fees of successful claimants. Although the private "bounty hunter" features of the FCA data back to the Civil War, these so-called qui tam claims were nearly dormant until 1986, when Congress amended the FCA to revive their use. Following the 1986 amendments, and paralleling the rapid increase in federal reimbursements for health care costs, private qui tam claims have far expanded beyond their traditional purview of defense contracts into the field of health care. By 1997, health care providers were the targets of 54 percent of the 530 private qui tam lawsuits field that year.     

Medicare Program; establishment of the Medicare+Choice Program--HCFA. Interim final rule with comment period

The Balanced Budget Act of 1997 (BBA) establishes a new Medicare+Choice (M+C) program that significantly expands the health care options available to Medicare beneficiaries. Under this program, eligible individuals may elect to receive Medicare benefits through enrollment in one of an array of private health plan choices beyond the original Medicare program or the plans now available through managed care organizations under section 1876 of the Social Security Act. Among the alternatives that will be available to Medicare beneficiaries are M+C coordinated care plans (including plans offered by health maintenance organizations, preferred provider organizations, and provider-sponsored organizations), M+C "MSA" plans, that is, a combination of a high deductible M+C health insurance plan and a contribution to an M+C medical savings account (MSA), and M+C private fee-for-service plans. The introduction of the M+C program will have a profound effect on Medicare beneficiaries and on the health plans and providers that furnish care. The new provisions of the Medicare statute, set forth as Part C of title XVIII of the Social Security Act, address a wide range of areas, including eligibility and enrollment, benefits and beneficiary protections, quality assurance, participating providers, payments to M+C organizations, premiums, appeals and grievances, and contracting rules. This interim final rule explains and implements these provisions. In addition, we are soliciting letters of intent from organizations that intend to offer M+C MSA plans to Medicare beneficiaries and/or to serve as M+C MSA trustees.