Office of Inspector General – Federal Register Recent Federal Regulation Documents

This proposed rule would amend the civil monetary penalty (CMP or penalty) rules of the Office of Inspector General (OIG) to incorporate new CMP authorities, clarify existing authorities, and reorganize regulations on civil money penalties, assessments and exclusions to improve readability and clarity.

In this final rule, the Office of Inspector General (OIG) amends the safe harbor regulation concerning electronic health records items and services, which defines certain conduct that is protected from liability under the Federal anti-kickback statute, section 1128B(b) of the Social Security Act (the Act). Amendments include updating the provision under which electronic health records software is deemed interoperable; removing the electronic prescribing capability requirement; extending the sunset provision until December 31, 2021; limiting the scope of protected donors to exclude laboratory companies; and clarifying the condition that prohibits a donor from taking any action to limit or restrict the use, compatibility, or interoperability of the donated items or services.

This notice announces the issuance of the updated Provider Self-Disclosure Protocol (the SDP), originally published in the Federal Register on October 30, 1998 (63 FR 58399). In 1998, the Office of Inspector General published the SDP to establish a process for health care providers to voluntarily identify, disclose, and resolve instances of potential fraud involving the Federal health care programs (as defined in section 1128B(f) of the Social Security Act (the Act), 42 U.S.C. 1320a-7b(f)). The SDP provides guidance on how to investigate this conduct, quantify damages, and report the conduct to OIG to resolve the provider's liability under OIG's civil monetary penalty (CMP) authorities. Since the original publication, we identified areas where additional guidance would be beneficial to the health care community and would improve the efficient resolution of SDP matters. To that end, we issued three Open Letters to Health Care Providers in 2006, 2008, and 2009. Since the last Open Letter, we continued to evaluate our SDP process. We also solicited comments about the SDP on June 18, 2012, and we received numerous helpful comments from the public. On the basis of our experience and the comments we received, we have decided to revise the SDP in its entirety at this time. This revised SDP supersedes and replaces the 1998 Federal Register Notice and the Open Letters. OIG has posted the full revision of the SDP on its Web site: http:/ /oig.hhs.gov/compliance/self-disclosure-info/index.asp.

This document sets forth a correction to the OIG Federal Register notice published on March 29, 2012 (78 FR 19271), on our recently issued Special Fraud Alert on Physician-Owned Entities. Specifically, the Special Fraud Alert addressed physician-owned entities that derive revenue from selling, or arranging for the sale of, implantable medical devices ordered by their physician-owners for use in procedures the physician-owners perform on their own patients at hospitals or ambulatory surgical centers. An inadvertent error appeared in the DATES caption of that document regarding the effective date. Accordingly, we are removing the language regarding the effective date to ensure technical correctness of the document.

This Special Fraud Alert addresses physician-owned entities that derive revenue from selling, or arranging for the sale of, implantable medical devices ordered by their physician-owners for use in procedures the physician-owners perform on their own patients at hospitals or ambulatory surgical centers (ASCs).

This Federal Register notice informs the public that OIG: (1) Intends to update the Provider Self-Disclosure Protocol (63 FR 58399, October 30, 1998) and (2) solicits input from the public for OIG to consider in updating the Protocol.

In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notice solicits proposals and recommendations for developing new and modifying existing safe harbor provisions under the Federal anti-kickback statute (section 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.

This notice seeks comment on an OIG proposal to revise standards for assessing the performance of the State Medicaid Fraud Control Units (MFCUs or Units). This proposal would replace and supersede standards published on September 26, 1994 (59 FR 49080).

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.

The Office of Inspector General (OIG) is deleting from its existing inventory of record systems subject to the Privacy Act of 1974, (5 U.S.C. 552a), as amended.

This document sets forth a correction to the OIG Federal

In accordance with section 205 of the Health Insurance Portability and Accountability Act (HIPAA) of 1996, this annual notice solicits proposals and recommendations for developing new and modifying existing safe harbor provisions under the Federal anti-kickback statute (section 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.

The Privacy Act of 1974 (5 U.S.C. 552(e)(4)) requires that all agencies publish in the Federal Register a notice of the existence and character of their system of records. Notice is hereby given that OIG is adding a new system of records entitled ``Consolidated Data RepositoryHHS-OIG'' (09-90-1000).

This Federal Register proposed notice seeks the comments of interested parties on a draft supplemental compliance program guidance (CPG) for nursing facilities developed by the Office of Inspector General (OIG). When OIG publishes the final version of this guidance, it will supplement OIG's prior CPG for nursing facilities issued in 2000. This proposed notice contains new compliance recommendations and an expanded discussion of risk areas. The proposed notice takes into account Medicare and Medicaid nursing facility payment systems and regulations, evolving industry practices, current enforcement priorities (including the Government's heightened focus on quality of care), and lessons learned in the area of nursing facility compliance. When published, the final supplemental CPG will provide voluntary guidelines to assist nursing facilities in identifying significant risk areas and in evaluating and, as necessary, refining ongoing compliance efforts.

The Office of Inspector General (OIG) is proposing a new system of records, entitled ``Administrative Files'' (09-90-0076). This proposed notice is in accordance with the Privacy Act requirement that agencies publish their systems of records in the Federal Register when there is a revision, change, or addition. This system of records contains certain administrative files for the purpose of maintaining, archiving, and filing records.

In accordance with section 205 of the Health Insurance Portability and Accountability Act (HIPAA) of 1996, this annual notice solicits proposals and recommendations for developing new and modifying existing safe harbor provisions under the Federal anti-kickback statute (section 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.

On September 15, 2003, we published a notice of proposed rulemaking (68 FR 53939) soliciting public comments regarding further guidance on OIG's exclusion authority under section 1128(b)(6)(A) of the Social Security Act and 42 CFR 1001.701 of our regulations. Having considered the public comments and for the reasons explained below, we are not promulgating a final rule.

The HHS Office of Inspector General Published a document in the Federal Register of October 18, 2006, imposed exclusions. The document contained the incorrect monthly exclusions.

The Office of Inspector General (OIG) is revising the existing system of records, entitled ``Criminal Investigative Files'' (09-90- 0003), by updating the ``Systems Location'' section of that document, and republishing the revised system of records in its entirety. This notice is in accordance with the Privacy Act requirement that agencies publish their amended systems of records in the Federal Register when there is a revision, change, or addition. This system of records, maintained by OIG, was last revised and updated on June 19, 2003 (68 FR 36828).

Under section 1909 of the Social Security Act (the Act), 42 U.S.C. 1396h, the Inspector General of the Department of Health and Human Services is required to determine, in consultation with the Attorney General, whether a State has in effect a law relating to false or fraudulent claims submitted to a State Medicaid program that meets certain enumerated requirements. If the Inspector General determines that a State law meets these requirements, the State medical assistance percentage, with respect to any amounts recovered under a State action brought under such a law, shall be increased by 10 percentage points. This notice sets forth the Inspector General's guidelines for evaluating whether a State law meets the requirements of section 1909 of the Act.