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.     

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 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.     

Federal laboratories & American industry: Fueling innovation

With a little-used gold mine of federal technical resources available to American industry, and adequate networking structure to expedite the transfer of valuable information is needed. The US government's laboratories have assisted some corporations, particularly those in defense-oriented industries, through collaborative research activities. To face the competition from abroad, a greater segment of American industry, of necessity, must tap the technical information and assistance available within the maze of federal laboratories to convert new and existing research into tangible, marketable products. NERAC has designed and tested an accessing model that matches the technological needs of American industry with federal experts through an existing network of federal-laboratory technology-transfer officers. The process is uncomplicated and direct. As a knowledgeable liaison, NERAC has developed a communication network to facilitate the transfer of often-unique material from the federal laboratories to American industry.     

Approval of the Commission on Office Laboratory Accreditation--HCFA. Notice

This notice announces the approval of the Commission on Office Laboratory Accreditation (COLA) as an accrediting organization for clinical laboratories under the CLIA program. We have found that the accreditation process of this organization provides reasonable assurance that the laboratories accredited by it meet the conditions required by Federal law and regulations. Consequently, laboratories that voluntarily become accredited by COLA in lieu of receiving direct Federal oversight and continue to meet COLA requirements would meet the CLIA condition level requirements for laboratories and therefore are not subject to routine inspection by State survey agencies to determine their compliance with Federal requirements. They are, however, subject to validation and complaint investigation surveys.     

CLIA program; approval of the College of American Pathologists--HCFA. Notice

This notice announces the approval of the College of American Pathologists (CAP) as an accrediting organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. We have found that the accreditation process of this organization provides reasonable assurance that the laboratories accredited by it meet the conditions required by Federal law and regulations. Consequently, laboratories that voluntarily become accredited by CAP in lieu of receiving direct Federal oversight and continue to meet CAP requirements would meet the CLIA condition level requirements for laboratories and therefore are not subject to routine inspection by State survey agencies to determine their compliance with Federal requirements. They are, however, subject to validation and complaint investigation surveys.     

Approval of the Commission on Office Laboratory Accreditation for Immunohematology--HCFA. Notice

This notice announces the approval of the Commission on Office Laboratory Accreditation (COLA), which is an accrediting organization for clinical laboratories under the Clinical Laboratory Improvement Amendments (CLIA) program, for the addition of the full specialty of immunohematology. This approval adds immunohematology to the specialties and subspecialties approved by HCFA in a notice published in the Federal Register on December 23, 1993 (58 FR 68148). We have found that the accreditation process of this organization provides reasonable assurance that the laboratories accredited by it for immunohematology meet the conditions required by Federal law and regulations. Consequently, laboratories that voluntarily become accredited by COLA for the specialty of immunohematology in lieu of receiving direct Federal oversight and continue to meet COLA requirements would meet the CLIA immunohematology condition level requirements for laboratories. These laboratories performing immunohematology testing are not subject to routine inspection by State survey agencies to determine their compliance with applicable Federal requirements. They are, however, subject to validation and complaint investigation surveys.     

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.     

意大利企业合规制度的全面解读及其启示

意大利是较早建立企业合规体系,法治经验相对成熟的国家。第231号法令跨越意大利《宪法》第27条的障碍,规定了判断企业责任的主客观标准,将企业责任建立在组织性罪过基础之上。企业免责的唯一途径是构建有效合规计划。如果企业能够证明在犯罪发生之前已采用并有效地实施了组织、管理和控制模式,则可以免除责任。该法令实施20年来,通过持续性革新,将反腐败合规计划由公共机构扩展至私营企业,规定合规计划中辩诉交易的适用条件,引入配额制的经济制裁手段,实现了自我完善。我国的企业合规改革刚刚起步,应当重视企业刑事合规的法治化,明确单位犯罪的归责基础,单位犯罪治理应当由事后惩治模式向事先预防的企业合规模式转变,立法上应当增设配额罚金制和褫夺资格处罚,以建立相对完善的、符合我国国情的企业合规制度。     

Administrative simplification: adoption of a standard for a unique health plan identifier; addition to the National Provider Identifier requirements; and a change to the compliance date for the International Classification of Diseases, 10th Edition (ICD-10-CM and ICD-10-PCS) medical data code sets. Final rule

This final rule adopts the standard for a national unique health plan identifier (HPID) and establishes requirements for the implementation of the HPID. In addition, it adopts a data element that will serve as an other entity identifier (OEID), or an identifier for entities that are not health plans, health care providers, or individuals, but that need to be identified in standard transactions. This final rule also specifies the circumstances under which an organization covered health care provider must require certain noncovered individual health care providers who are prescribers to obtain and disclose a National Provider Identifier (NPI). Lastly, this final rule changes the compliance date for the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) for diagnosis coding, including the Official ICD-10-CM Guidelines for Coding and Reporting, and the International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS) for inpatient hospital procedure coding, including the Official ICD-10-PCS Guidelines for Coding and Reporting, from October 1, 2013 to October 1, 2014.     

Clinical Laboratory Improvement Act program fee collection--HCFA. Final rule with comment

This rule implements provisions of section 353 of Public Health Service Act (as amended by the Clinical Laboratory Improvement Amendments of 1988). Those provisions require laboratories to pay fees for issuance of registration certificates, certificates of waiver, certificates of accreditation, or certificates and to fund activities to determine compliance with the requirements established by the Department of Health and Human Services for laboratory testing. It also establishes the policy that laboratories licensed by and located in States with licensure programs approved by HHS may be exempt from the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This rule also establishes the methodology used to determine the amount of the fees charged for certificates of waiver, registration certificates, certificates of accreditation, or certificates and activities to establish application procedures and determine compliance with applicable certification requirements.     

Compliance with Food Safety Laws in Germany: Food Businesses in Berlin

In this article we explore how variables associated both with material temptations (economic incentives that foster rule breaking) and nonmaterial behavioral determinants (protective factors that shield people from rule breaking) are linked to compliance with food laws. The object of the study is to examine food businesses in the ready‐to‐eat industry in three districts of the German capital, Berlin. We collected data on compliance behavior and its potential drivers via an anonymous postal survey in 2014. Accounting for the data structure, we used a generalized ordered logit regression to model the relationship between the presumed behavioral drivers and compliance. One crucial finding is that a feeling of embarrassment if relevant others were to learn about noncompliance is positively related to compliance. The same holds for the internalized approval of food laws and their enforcement (acceptance of rules).     

UK further education sector journey to compliance with the general data protection regulation and the data protection act 2018

The Further Education sector provides training and qualifications to 2.2million young people and adults annually and in the process collect a wealth of data which must be properly managed to ensure it is processed in a fair and transparent manner, maintaining compliance with good information governance and data protection legislation. This article shares the findings of a study which explored the content of General Data Protection Regulation action plans, first hand accounts from data practitioners and the views of students as provides embraced the new legislation.The article demonstrates how a sector which fills the void between schools and universities is unique in the challenges they face when ensuring compliance with data protection laws. These challenges include the application of legislation, noting key differences between the nations of the United Kingdom, and the moral duties placed upon the provider by parents who expect open dialogue with the education provider, consistent as happened with lower levels of education. This must be balanced with the student's right to data privacy and control over who can access their educational records .     

A step towards improving workflow practices for volume crime investigations: outcomes of a 90-day trial in South Australia

The provision of forensic science services in volume crime investigations works most successfully as a partnership between police agencies and external forensic laboratories as opposed to a client/provider model where unlimited demand ignores finite resources. The principles of Lean Six Sigma have been applied in various laboratories to improve workflow through identification of wasteful work practices. These strategies are aimed at process optimisation through the application of triaging, a concept that has rarely been studied yet referenced strongly in the literature. The South Australia End to End 90-Day Trial: facilitating quicker justice through timely evidence processing, is a collaborative approach between South Australia Police and Forensic Science South Australia. This trial applied evidence-based policing principles, a law enforcement philosophy that uses research undertaken with scientific processes to inform law-enforcement decision-making. The results demonstrate how a review of processes and the removal of non-value adding activities can improve service delivery while not exhausting those ‘finite resources’.     

Industry interactions with federal laboratories

This article is based on two surveys of US firms, all of them members of the Industrial Research Institute, on their interactions with university and federal laboratories. It covers mainly the federal part of the responses. Although questions remain to be answered (a followup survey is planned for mid-1991), the firms had a surprisingly high level of awareness of and interaction with the federal laboratories. Many of them plan to increase their external R&D funding. We believe the firms including such external resources in their strategic planning will achieve stronger competitive positions than those that do not. Director of the Graduate Program in Technology and Science Policy. Previously, he was principal scientist and group manager for Industrial Policy and Planning at the Solar Energy Research Institute in Golden, Colorado. He also served as policy analyst with the National Science Foundation's R&D Assessment Program and, subsequently, as acting leader of the Working Group on Innovation Processes and their Management. Roessner received degrees in electrical engineering from Brown University and Stanford University, and a master's degree and Ph.D. in Science, Technology and Public Policy at Case Western Reserve University. His research interests include the diffusion of technological innovations, national technology policy, government-industry relationships in technology development and use, the management of innovation in industry, and indicators of scientific and technological development.     

Special report on labor and employment. Provider obligations under the Drug-Free Workplace Act

In view of the sanctions that may be taken by government agencies against employers, all providers should take their obligations under the Act seriously. The first step for each provider is to determine if it is subject to the Act or to any analogous state statutes. If so, the provider should take steps, if it has not already done so, to comply with the Act or applicable state legislation. While the Act has been criticized as a matter of social policy for not going further to prevent substance abuse in the workplace--by, for example, mandating drug testing or requiring sanctions against employees without the prerequisite of a criminal conviction--there is no question that the penalties it authorizes against employers do go far enough to warrant careful compliance with the Act's provisions.