This paper will address the varying requirements for fair market value in transactions involving physicians and hospitals and other health care providers. The paper will first examine the Stark law and how and when transactions may satisfy Stark’s requirements for fair market value. Second, the use of fair market value for compliance with the federal Anti-Kickback statute will be addressed ...
In the past few years China has introduced significant regulatory changes in an effort to modernize its pharmaceutical industry and bring it in line with international standards. These include reorganizing the former State Drug Administration into the State Food and Drug Administration (SFDA), thoroughly amending drug regulation and good manufacturing practice (GMP), enhancing intellectual property protection and changing drug import licensing ...
The purposes of this Health Care Alert are to: 1) summarize recently proposed federal regulations which will require physician disclosure of ownership interests in hospitals to patients; 2) remind health care providers of existing Texas laws requiring disclosure of ownership interests and 3) suggest best practices for disclosure of ownership interests ...
On Capitol Hill, U.S. lawmakers are considering legislation that would authorize the U.S. Food and Drug Administration (FDA) to approve generic versions of biological products. Representative Henry Waxman (D, CA), of “Hatch-Waxman” fame, has introduced the “Access to Life Saving Medicine Act” (H.R. 1038) to advance this change to U.S. law. In introducing the legislation, Rep ...
A reputation for counterfeiting, poor quality control, ever-changing and inconsistent application of regulations and the challenges of ensuring that development does not unduly prejudice the welfare of the general population - this description of China’s pharmaceutical industry is representative of much that is good, bad and challenging in China’s recent regulatory and economic development ...
Currently Romania’s market is characterized by the implementation of two seemingly opposite sets of actions, one aimed at ensuring Romania’s transition to the market economy and the achievement of economic growth, while the other is targeting the environmental protection through promotion of energy efficiency and use of renewable energy sources for electricity generation ...
On February 27 British Columbia issued “The BC Energy Plan: A Vision for Clean Energy Leadership” (Energy Plan 2007). The document is an extensive statement of provincial energy policy, and a roadmap for future government action in BC’s energy sector ...
The Texas Commission on Environmental Quality (“TCEQ”) is accepting comments on a draft guidance document that addresses air quality emissions and regulatory compliance for storage tanks using floating roofs ...
Dramatic changes in global climate have helped to wake up the consciousness of States on the significance of environmental issues in the last fourty years. Before then countries focused their energies on relentless industrial development with little or no attention to its impact on the environment. Scientific evidence has shown that unbridled development leads to loss of environmental capital, sometimes an irreversible phenomenon ...
Since the entry into force of the Freedom of Information Act 2000 and the Freedom of Information (Scotland) Act 2002 on 1 January 2005, the general public and those in business seem, by and large, to be well aware of the potential benefits of the legislation. Information covering a plethora of topics has been accessed and used for a huge variety of purposes ...
Pursuant to the Act on Drugs, the Ministry of Health of the Slovak Republic has specified in annexes to this Decree details on forms to be used for prescriptions of drugs and medical aids. By this Decree, the Ministry also has set the sample forms of medical prescription, special medical prescription, medical reference, and extract from medical prescription, order and special order ...
The federal Pipeline and Hazardous Material Safety Administration (PHMSA) has proposed new regulations for rural onshore low stress pipelines and rural onshore gathering lines. Although PHMSA has been anticipating further regulation of these types of lines for the past few years, the Agency acknowledges that the proposed rule is a direct response to legislative and media scrutiny of recent incidents that occurred in the Alaska Prudhoe Bay field ...
In the world of information legislation in Scotland, the Freedom of Information (Scotland) Act 2002 ("FOISA") reigns supreme. But is this Act the most appropriate tool to use in all circumstances? The answer is most definitely no. Lurking behind this headline Act are two pieces of other information-related legislation that, in many circumstances, are more powerful tools to access and use certain information ...
As the poultry farming crisis looms and countries are on the lookout for outbreaks of infection, scientists are closely following the evolution of the virus, which is moving to new sources of infection.Before a crisis is on our doorstep, businesses should prepare themselves for the consequences of a high rate of absenteeism. Without exaggerating the risks, they should adopt preventive strategies and become aware of the legal ins and outs of their actions ...
Interdisciplinary collaborations and partnering across the medical research and life sciences sectors are becoming increasingly common. Large corporations with good industry reputations and large research budgets are seeking to collaborate with smaller companies developing next-generation products. Equally, smaller companies are coming together to share complementary know-how and technologies and to work together in the global marketplace ...
ALERT Hospital May Be Excluded For Physician Recruiting On May 8, 2006 the OIG announced that it intends to exclude San Diego-based Alvarado Hospital from participation in Medicare, Medicaid and all other federal health care programs because of payments the Hospital made under relocation agreements involving placement of newly-recruited physicians in established physician practices ...
Certificate of Need Strategies for New Nursing Home Beds Special Population Beds are Re-Approved At its March 2006 meeting, the Michigan Certificate of Need (“CON”) Commission took action to re-approve several state-wide pools of nursing home beds that are set aside to serve special populations, including: Alzheimer’s Use 60 beds Hospice 30 beds Religious Use 20 beds The Commission reserved 22 special population beds on a non-specified basis for future use ...
In its 1993 decision in U.S. v. Rohm & Haas, the Third Circuit held that EPA could not recover CERCLA oversight costs for supervising a private party removal action. The Court reasoned that the U.S. Supreme Court’s decision in National Cable Television Ass’n, Inc. v. U.S. barred recovery of such costs “unless the statutory language clearly and explicitly requires that result ...
IN OUR JUNE 2005 “FDA WATCH” column, we provided an overview of the regulatory, political, and scientific landscape for follow-on biological products in the U.S. As reported a year ago, the biogenerics debate centers around whether generic biologics are scientifically possible (i.e ...
The Environmental Protection Agency (EPA) has published a draft of Ireland’s second National Allocation Plan for Emissions Trading in Ireland. This follows a recent announcement by the Minister for the Environment, Heritage and Local Government, Mr. Dick Roche, T.D., which set out the total quantity of Carbon Dioxide (CO2) allowances being made available by Government to Ireland’s emissions trading sector ...
Scope of this treatiseThe purpose of this discussion is to address those cases which are most likely to have a significant effect for those practicing in the chemical, pharmaceutical and biotech areas ...
The Federal Electricity Commission (the “Commission”) will put out for public bidding the construction and operation of a hydroelectric plant named “La Yesca.” The plant will be located 65 kilometers from the El Cajon Dam, between the boundaries of the states of Nayarit and Jalisco ...
In April 2005 a new Disability Discrimination Act was passed by Westminster. The Act extends existing non-discrimination legislation, primarily the Disability Discrimination Act 1995. While some provisions of the Act came into force in December 2005, many others will be coming into force over the course of 2006. It is essential that businesses are aware of their new responsibilities under the Act and prepare for its implementation ...
On November 29, 2005, the Chamber of Deputies of Mexico’s Congress approved a draft of the “Civil Liability for Environmental Damage Law” (the “Bill”) which regulates liability for acts or omissions which have an adverse impact on the environmental. The Bill was sent to the Senate on December 1, 2005 and is now in the process of being studied by the Environmental, Economic Development, Justice and Legislative Studies Committees ...
