Medicare program; availability of Medicare data for performance measurement. Final rule

This final rule implements Section 10332 of the Affordable Care Act regarding the release and use of standardized extracts of Medicare claims data for qualified entities to measure the performance of providers of services (referred to as providers) and suppliers. This rule explains how entities can become qualified by CMS to receive standardized extracts of claims data under Medicare Parts A, B, and D for the purpose of evaluation of the performance of providers and suppliers. This rule also lays out the criteria qualified entities must follow to protect the privacy of Medicare beneficiaries.     

Medical devices; ovarian adnexal mass assessment score test system; labeling; black box restrictions. Final rule

The Food and Drug Administration (FDA) is amending the regulation classifying ovarian adnexal mass assessment score test systems to restrict these devices so that a prescribed warning statement that addresses a risk identified in the special controls guidance document must be in a black box and must appear in all labeling, advertising, and promotional material. The black box warning mitigates the risk to health associated with off-label use as a screening test, stand-alone diagnostic test, or as a test to determine whether or not to proceed with surgery.     

Requiring use of electronic services by certain claimant representatives. Final rules

We are revising our rules to require that claimant representatives use our electronic services as they become available on matters for which the representatives request direct fee payment. In the future, we will publish a notice in the Federal Register when we require representatives who request direct fee payment on a matter to use our available electronic services. We are also adding the requirement to use our available electronic services on matters for which the representative requests direct fee payment as an affirmative duty in our representative conduct rules. These revisions reflect the increased use of technology in representatives' business practices. We expect that the use of electronic services will improve our efficiency by allowing us to manage our workloads more effectively. These rules do not require claimants to use our available electronic services directly; they only require their representatives to use the services on matters for which the representatives request direct fee payment.     

International Conference on Harmonisation; Guidance on E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions.' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes recommendations regarding the context, structure, and format of qualification submissions for clinical and nonclinical genomic biomarkers related to development of drug or biotechnology products, including translational medicine approaches, pharmacokinetics, pharmacodynamics, and efficacy and safety aspects. The guidance is intended to create a harmonized recommended structure for biomarker qualification applications that will foster consistency of applications across regions and facilitate discussions with and among regulatory authorities.     

Medicare program; hospice wage index for fiscal year 2012. Final rule

This final rule will set forth the hospice wage index for fiscal year (FY) 2012 and continue the phase-out of the wage index budget neutrality adjustment factor (BNAF), with an additional 15 percent BNAF reduction, for a total BNAF reduction in FY 2012 of 40 percent. The BNAF phase-out will continue with successive 15 percent reductions from FY 2013 through FY 2016. This final rule will change the hospice aggregate cap calculation methodology. This final rule will also revise the hospice requirement for a face-to-face encounter for recertification of a patient's terminal illness. Finally, this final rule will begin implementation of a hospice quality reporting program.     

Medical devices; neurological devices; classification of repetitive transcranial magnetic stimulation system. Final rule

The Food and Drug Administration (FDA) is classifying the repetitive transcranial magnetic stimulation (rTMS) system into class II (special controls). The Agency is classifying this device type into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices.     

Cardiovascular devices; classification of electrocardiograph electrodes. Final rule

The Food and Drug Administration (FDA) is classifying the electrocardiograph electrode, intended to acquire and transmit the electrical signal at the body surface to a processor that produces an electrocardiogram (ECG) or vectorcardiogram, into class II (special controls). FDA is also exempting this device from the premarket notification requirement.     

从工业社会到生态社会:政府的功能与定位

工业文明在给人类社会带来史无前例经济增长的同时,也给人类赖以生存的自然环境带来了毁灭性的破坏。西方学界和政界对此进行了深刻的反思,开始逐步走向关注生态与社会和谐发展之路。中国社会正处于工业化中期,要怎样发展才能避免重蹈西方社会的覆辙?中国工业社会将走向何方?生态社会的理论为我们提供了全新的视野。什么是生态社会?为什么说生态社会是工业社会的必然走向?在从工业社会到生态社会的转变过程中政府该充当什么样的角色?本文通过对这一系列问题的回答,得出结论:生态社会是工业社会的必然走向,然而工业社会不会自发过渡到生态社会,在这个过程中,政府起到了助推器的作用。     

突发事件管理中的政府信息公开

应急信息公开是政府的职责,必须坚持依法公开、准确发布、及时传播和适时反馈的原则。在具体操作上,政府必须紧扣事件动态,抢占话语先机;把握事发状态,掌握传播节奏;坦诚公开表态,满足公众期待;抚平公众心态,引导社会舆论;注重公众情态,赢得人民支持;恢复发布常态,消除各方疑虑。     

网络公关异化:现象、原因与监管

网络公关是传统公关与信息技术相结合的产物,其目的是组织通过与公众的双向互动实现良好的组织形象。作为新兴的产业,网络公关在发展过程中出现杜撰口碑、歪曲事实、操纵舆论及暴力营销等异化现象。为促进公关行业有序发展,维持网络市场的竞争秩序,政府与市场要采取纠偏措施,对网络公关主体进行分层监管;同时平等监管公关客体,协调公关客体与主体间的关系;规范网络公关的运作方式,使整个公关行业进入良性发展轨道。