Patient Protection and Affordable Care Act; establishment of exchanges and qualified health plans; exchange standards for employers. Final rule, Interim final rule

This final rule will implement the new Affordable Insurance Exchanges ("Exchanges"), consistent with title I of the Patient Protection and Affordable Care Act of 2010 as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. The Exchanges will provide competitive marketplaces for individuals and small employers to directly compare available private health insurance options on the basis of price, quality, and other factors. The Exchanges, which will become operational by January 1, 2014, will help enhance competition in the health insurance market, improve choice of affordable health insurance, and give small businesses the same purchasing clout as large businesses.     

Crossroads and Pitfalls of the Transition Period

The theme of the crisis of Russian society continues to occupy a leading place in our publications. However, the economic woes clearly felt by all have meant that discussions have been predominantly, if not exclusively, concerned with the economic component of the crisis. The reasons for the failures in this sphere are often sought in subjective weaknesses, in our habitual revealing of the "sources of evil," whether these be specific persons (Yeltsin and Gaidar, Chernomyrdin and Zaveriukha, Khasbulatov and Rutskoi), entire groups (the "nomenklatura" the "red—browns," the "agrarians," the "democrats," the "monetarists"), or external forces ("imperialists," "freemasons"), and so on. Accordingly, the solutions to the crisis are also quite simple: one need only replace an "incorrect" program with a "correct" one, remove the "sources of evil" and "agents of influence" from power, then all the problems will resolve themselves (by spring or fall, in a year or two, depending directly on the temperament of the particular healer of society and inversely on the degree to which he is informed).     

Strategies to enhance price and quality competition in health care: lessons learned from tracking local markets

Drawing on observations from tracking changes in local health care markets over the past ten years, this article critiques two Federal Trade Commission and Department of Justice recommendations to enhance price and quality competition. First, we take issue with the notion that consumers, acting independently, will drive greater competition in health care markets. Rather we suggest an important role remains for trusted agents who can analyze inherently complex price and quality information and negotiate on consumers' behalf. With aggregated information identifying providers who deliver cost-effective care, consumers would be better positioned to respond to financial incentives about where to seek care and thereby drive more meaningful competition among providers to reduce costs and improve quality. Second, we take issue with the FTC/DOJ recommendation to provide more direct subsidies to prevent distortions in competition. In the current political environment, it is not practical to provide direct subsidies for all of the unfunded care that exists in health care markets today; instead, some interference with competition may be necessary to protect cross subsidies. Barriers can be reduced, though, by revising pricing policies that have resulted in marked disparities in the relative profitability of different services.     

Notice regarding section 602 of the Veterans Health Care Act of 1992 inclusion of outpatient hospital facilities--PHS. Notice

Section 602 of Public Law 102-585, the "Veterans Health Care Act of 1992" (the "Act"), enacted section 340B of the Public Health Service Act ("PHS Act"), "Limitation on Prices of Drugs Purchased by Covered Entities." Section 340B provides that a manufacturer who sells covered outpatient drugs to eligible entities must sign a pharmaceutical pricing agreement (the "Agreement") with the Secretary, Department of Health and Human Services, in which the manufacturer agrees to charge a price for covered outpatient drugs that will not exceed the amount determined under a statutory formula. Section 340B(a)(4) lists the entities eligible to receive discount outpatient drug pricing (i.e., certain disproportionate share hospitals (DSHs) and PHS grantees). The definition of a disproportionate share hospital found in section 340B(a)(4)(L) provides criteria to determine which such hospitals are eligible to participate in the program. However, the definition does not include criteria to determine which outpatient facilities (including off-site or satellite clinics) working in conjunction with the eligible hospital would be considered part of the hospital for purposes of eligibility for section 340B drug discounts. The Office of Drug Pricing, which administers this program with PHS, is proposing certain procedures to determine which outpatient hospital facilities are included as part of an eligible disproportionate share hospital.     

Exemption of certain systems of records under the Privacy Act. Proposed rule

This proposed rule would exempt the four system of records from subsections (c)(3), (d)(1) through (d)(4),(e)(4)(G) and (H), and (f) of the Privacy Act pursuant to 5 U.S.C. 552a (k)(2): The Automated Survey Processing Environment (ASPEN) Complaint/Incidents Tracking System ("ACTS"), HHS/CMS, System No. 09-70-0565; the Health Insurance Portability and Accountability Act (HIPAA) Information Tracking System ("HITS"), HHS/CMS, System No. 09-70-0544; the Organ Procurement Organizations System ("OPOS"), HHS/CMS, System No. 09-70-0575; and the Fraud Investigation Database ("FID"), HHS/CMS, System No. 09-70-0527.     

Procedures for designating classes of employees as members of the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000; Final rule. Final rule

This document describes how the Department of Health and Human Services ("HHS") will consider designating classes of employees to be added to the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000 ("EEOICPA'). Under EEOICPA, and Executive Order 13179, the Secretary of HHS is authorized to make such designations, which take effect 180 days after Congress is notified unless Congress provides otherwise. An individual member (or the eligible survivors of a member) of a class of employees added to the Special Exposure Cohort would be entitled to compensation if the Department of Labor ("DOL") finds that employee incurred a specified cancer and the claim meets other requirements established under EEOICPA.     

Notice regarding Section 602 of the Veterans Health Care Act of 1992; new drug pricing--PHS. Final notice

Section 602 of Public Law 102-585, the "Veterans Health Care Act of 1992," enacted section 340B of the Public Health Service Act ("PHS Act"), "Limitation on Prices of Drugs Purchased by Covered Entities." Section 340B provides that a manufacturer who sells covered outpatient drugs to eligible entities must sign a pharmaceutical pricing agreement with the Secretary of Health and Human Services in which the manufacturer agrees to charge a price for covered outpatient drugs that will not exceed an amount determined under a statutory formula. The purpose of this notice is to inform interested parties of final guidelines regarding new drug pricing.     

欧盟法对企业合并的规制

企业合并是当今各国优化产业结构和企业组织结构的重要手段,也是企业迅速扩张、提高规模经济效益和国际竞争力的有效手段.然而,经济力量的集中和由此导致的市场结构的改变,容易产生或加强市场支配力量,从而起到排除或限制竞争的作用.为了防止企业通过并购实现或加强市场支配地位,维护市场上的竞争秩序,对一定规模以上的企业并购交易进行反垄断审查,已成为市场经济国家设计和实施反垄断法的通行做法.目前,已有七十多个国家建立了企业并购控制机制.其中十分引人注目的是,欧盟于上世纪90年代初建立了企业合并控制机制,并于2004年进行了改革.到目前为止,欧盟竞争总司作出的并购审查决定已达两千多件,在此过程中积累了丰富的经验.拟对欧盟企业合并控制制度的建立、理论、程序及实体规则进行研究,并就中国企业合并控制制度的现状及发展提出自己的看法.     

Limited Liability Companies and Technology Transfer

This paper provides an introduction to a new organizational form of business in the United States, the Limited Liability Company (LLC), and explores the potential use of LLCs for technology-transfer arrangements. Favorable characteristics of LLCs are limited liability for all equity holders, avoidance of corporate double taxation, flexibility of organizational form and distributions of profit, and few restrictions on membership. An unfavorable characteristic is that shares in an LLC cannot be publicly traded. The paper argues that, overall, the LLC form promotes certain types of strategic alliances, including those dealing with technology transfer. In particular, LLC characteristics lend themselves well to strategic alliances that form to share risk, exploit complementary assets, reduce transactions costs, overcome investment barriers, exchange technology, speed innovation and development, and make international expansions. The paper also points out why technology-transfer arrangements can and will continue to take on other forms as well.     

Genetic discrimination: Huntington's disease and the Americans with Disabilities Act

This Note discusses the potential for genetic discrimination, current views as to whether genetic conditions will be covered by the Americans with Disabilities Act ("ADA"), and the specific issue of whether presymptomatic persons who test positive for Huntington's disease should be classified as persons with a "disability" within the meaning of the ADA. In considering whether presymptomatic Huntington's individuals have a disability under the ADA, an analogy is made between Huntington's disease and HIV-positive status. Inter alia, Huntington's disease and HIV-positive status are analogous in that, at the time of diagnosis, victims of both diseases may have no symptoms and may remain healthy for a number of years; but even though the exact time of onset of both diseases is unascertainable, death of both victims within a given range of years is highly likely. Further, both Huntington's disease and HIV are transmitted to offspring at a relatively high rate. Given these similarities, the author argues that Huntington's individuals should be afforded the protections of the ADA for the same reasons that HIV-positive persons are protected.     

Sample patient medical information use and disclosure notice

In accordance with the federal health privacy standards promulgated pursuant to the Health Insurance Portability and Accountability Act of 1996 ("HIPAA"), covered entities must provide adequate notice to individuals of their policies and procedures regarding protected health information. The form below may be used as a starting point by covered entities for the development of such notice.     

Department of Justice challenging big insurers' "Most Favored Nation" clauses

The DOJ's latest actions suggest that MFNs in managed care contracts should be evaluated on a case-by-case basis, focusing on the actual or potential impact that the MFNs have on price competition among providers and payors in the relevant marketplace. For health care providers desiring to avoid MFNs, however, the DOJ's heightened activity in this area might furnish an appropriate reason to resist such clauses. To date, the DOJ's focus has been on the market power of payors with MFN status. However, the DOJ's reasoning applies equally to providers that wield buying power in contracting with others. Although the DOJ has yet to take up this latter issue, MFNs imposed by increasingly powerful provider organizations can expect to receive similar scrutiny from the DOJ, especially as their market influence grows.     

Performance of functions; claims for compensation under the Energy Employees Occupational Illness Compensation Program Act. Interim final rule; request for comments

This document contains the interim final regulations governing the administration of the Energy Employees Occupational Illness Compensation Program Act of 2000, as amended (EEOICPA or Act) by the Department of Labor (Department or DOL). Part B of the Act provides uniform lump-sum payments and medical benefits to covered employees and, where applicable, to survivors of such employees, of the Department of Energy (DOE), its predecessor agencies and certain of its vendors, contractors and subcontractors. Part B of the Act also provides smaller uniform lump-sum payments and medical benefits to individuals found eligible by the Department of Justice (DOJ) for benefits under section 5 of the Radiation Exposure Compensation Act (RECA) and, where applicable, to their survivors. Part E of the Act provides variable lump-sum payments (based on a worker's permanent impairment and/or years of established wage-loss) and medical benefits for covered DOE contractor employees and, where applicable, provides variable lump-sum payments to survivors of such employees (based on a worker's death due to a covered illness and any years of established wage-loss). Part E of the Act also provides these same payments and benefits to uranium miners, millers and ore transporters covered by section 5 of the RECA and, where applicable, to survivors of such employees. The Office of Workers' Compensation Programs (OWCP) administers the adjudication of claims and the payment of benefits under EEOICPA, with the Department of Health and Human Services (HHS) estimating the amounts of radiation received by employees alleged to have sustained cancer as a result of such exposure and establishing guidelines to be followed by OWCP in determining whether such cancers are at least as likely as not related to employment. Both DOE and DOJ are responsible for notifying potential claimants and for submitting evidence necessary for OWCP's adjudication of claims under EEOICPA.     

公司法语境下的重大资产出售定位——兼评《公司法》第75条、第105条和第122条

对重大资产出售的界定,应采取质与量相结合的标准:在质的方面,要求出售标的必须是经营性资产;在量的方面,要求出售标的须达到净资产总额的一定比例以上,且动摇了公司的存续基础。在公司拥有单一营业的情况下,出售行为只须满足质的标准,即可构成重大资产出售;在公司拥有多项营业的情况下,出售行为还须满足量的标准,方可构成重大资产出售。我国现行立法对重大资产出售的界定尚不准确,因而值得探讨。     

Recent developments in employee benefits law

The first part of this article highlights important judicial developments involving employee benefits and the Employee Retirement Income Security Act of 1974 ("ERISA"), as amended, during the latter part of 2003 and the first part of 2004, including the most significant U.S. Supreme Court and federal circuit court decisions. The second part covers recent legislative and regulatory developments in employee benefits law. This article is not meant to be exhaustive, but discusses the more important developments during 2003-2004, with particular focus on issues of concern to the insurance industry.     

New drug, antibiotic, and biological drug product regulations; accelerated approval--FDA. Final rule

The Food and Drug Administration (FDA) is issuing final regulations under which the agency will accelerate approval of certain new drugs and biological products for serious or life-threatening illnesses, with provisions for any necessary continued study of the drugs' clinical benefits after approval or with restrictions on use, if necessary. These new procedures are intended to provide expedited marketing of drugs for patients suffering from such illnesses when the drugs provide meaningful therapeutic benefit compared to existing treatment. Accelerated approval will be considered in two situations: (1) When approval can be reliably based on evidence from adequate and well-controlled studies of the drug's effect on a surrogate endpoint that reasonably suggests clinical benefit or on evidence of the drug's effect on a clinical endpoint other than survival or irreversible morbidity, pending completion of studies to establish and define the degree of clinical benefits to patients; and (2) when FDA determines that a drug, effective for the treatment of a disease, can be used safely only if distribution or use is modified or restricted. Drugs or biological products approved under these procedures will have met the requisite standards for safety and effectiveness under the Federal Food, Drug and Cosmetic Act (the act) or the Public Health Service Act (the PHS Act) and, thus, will have full approval for marketing.     

Smallpox Vaccine Injury Compensation Program: administrative implementation. Interim final rule

The Smallpox Emergency Personnel Protection Act of 2003 (SEPPA), authorizes the Secretary of Health and Human Services (the Secretary), to establish the Smallpox Vaccine Injury Compensation Program ("the Program"). This program is designed to provide benefits and/or compensation to certain persons harmed as a direct result of receiving smallpox covered countermeasures, including the smallpox vaccine, or as a direct result of contracting vaccinia through certain accidental exposures. In addition, the Secretary may provide death benefits to certain survivors of individuals who died as the direct result of these injuries. On August 27, 2003, the Secretary published an interim final rule that set out a Smallpox (Vaccinia) Vaccine Injury Table ("the Table"). The table includes adverse effects (including injuries, disabilities, conditions, and deaths) within specific time periods that shall be presumed to result from the receipt of, or exposure to, the smallpox vaccine. The Secretary will use this table, as well as the procedures set out in this regulation, in deciding whether persons are eligible to receive benefits under the program. In this interim final rule, the Secretary is setting out the administrative policies, procedures, and requirements governing the program, as authorized by the SEPPA. The Secretary is seeking public comment on this interim final rule.     

《民法典》夫妻债务条款的不足与应对

《民法典》第1064条关于夫妻债务的条款源于《最高人民法院关于审理涉及夫妻债务纠纷案件适用法律有关问题的解释》,该条款原来只针对夫妻对外关系,上升为法律条文后同时适用于夫妻对内和对外关系,即“内外同一”模式。由于债权人不易了解夫妻内部情况,这种做法较易损害债权人利益,对此可以通过适当放宽债权人举证责任和强化法院职权探知予以应对。该条文从司法解释上升为法律条文时与第1089条的衔接不够顺畅,遗漏了夫妻中举债一方的举证责任,应予补充。在内容上,该条第1款和第2款都出现“共同意思表示”,鉴于该条款的法理基础是《最高人民法院关于适用〈中华人民共和国婚姻法〉若干问题的解释(一)》第17条,建议将第1款的“共同意思表示”解释为签订合同的民事法律行为,将第2款的“共同意思表示”解释为表见代理。此外,条文中的夫妻“共同生产经营”的含义具有不确定性,建议对其进行目的性扩张解释。     

反思·借鉴·重构——关于完善我国家庭暴力概念的思考

根据最高人民法院的司法解释,家庭暴力是指行为人以殴打、捆绑、残害、强行限制人身自由或者其他手段,给其家庭成员的身体、精神等方面造成一定伤害后果的行为。这在一定程度上解决了新婚姻法颁布后所遇到的司法实践难题,具有十分重要的积极意义。然而,基于家庭暴力的普遍性和复杂性,该解释仍显不足,司法实践中困惑犹存。因此,有必要重新界定家庭暴力概念,完善相关理论,以利于司法实践中正确认定家庭暴力和有效处理相关纠纷。     

企业海外并购的国家安全审查风险及其法律对策

国家安全审查是对企业海外并购影响最大的贸易保护措施。近年来,数个国家对其外资监管法律进行了修改,其共性是建立或完善外资并购国家安全审查制度。这种对国家安全审查的关注和强调已经成为中国企业海外并购所面临的最大法律风险。从国家安全审查的法律实践中可见两个明显趋势:国家安全概念的扩张与审查过程中政治考量因素的增加,但中国企业应将政治风险与政治因素转换为法律层面的问题,合理进行并购申报,并通过东道国诉讼程序、WTO规则、双边投资保护协定等多种法律手段维护自身利益,减少贸易保护主义对海外并购的危害。