CMS recently released new regulations intended to curb the ability of a physician to earn a profit on either the technical component (TC) or professional component (PC) of tests ordered by the physician, but performed by another party. The regulation is effective January 1, 2008 and applies to all Medicare-covered diagnostic tests including imaging and anatomic pathology, but excluding clinical laboratory tests ...
Savings and expected recoveries of $43 billion were reported by the Department of Health and Human Services Office of the Inspector General (OIG) in its Semiannual Report to Congress on December 14, 2007, for fiscal year 2007 (October 2006 – September 2007). This represents $2.18 billion in investigative recoveries, $1 ...
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 ...
On May 25, 2007, the Supreme Court of Canada rendered a unanimous decision in favour of our client, Transat Tours Canada Inc., a subsidiary of the Transat A.T. Inc. group, which ranks among the ten largest tourism businesses in the world. This precedent is of crucial importance for Canadian firms carrying on business abroad ...
In accordance with its announcement in its Notice of Intent published on October 21, 2006(1), the federal government, on April 26, published the regulatory framework it favours for greenhouse gases emissions and other air pollutants.The “Regulatory Framework for Air Emissions”, despite its title, is not a restrictive regulation ...
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 ...
On 15 March 2007, the European Court of Justice confirmed that the European Commission had been correct to fine British Airways £6.8 million for abusing its dominant position by operating loyalty enhancing performance bonus schemes for travel agents since the schemes had the effect of excluding competitors without any objective economic justification ...
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 ...
British Airways' 14-year long wrangle with Virgin and the European Commission ended yesterday, when Europe's highest court confirmed that the Commission was right in fining BA EUR6.8m. For BA this comes at an inopportune moment, as it is currently under investigation by both the US Federal Trade Commission and the EU Commission for alleged breaches of anti-cartel provisions ...
The European Court of Justice (ECJ) has ruled that motor vehicle distribution agreements may benefit from the exemption in Regulation 1400/2002 (Block Exemption) even if the supplier can terminate the agreement without notice in certain circumstances. The Block Exemption applies to such agreements provided the supplier gives reasons for the termination which are subject to review by an independent expert or arbitrator ...
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 ...
Pursuant to the Act on Budget Rules for Public Administration, the Ministry of Transport, Posts and Telecommunications of the Slovak Republic, by this Ruling, enlarged the scope of persons entitled to subsidies ensuring higher penetration of broadband internet access ...
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 ...
The main legal acts regulating the registration of seagoing ships in Lithuania are the Law on Merchant Shipping, the Rules for Registration of Seagoing Ships in Lithuania approved on 4 July 2005 by order No. 3-301 of the Minister of Transport and Communications, and the Decision of the Government of Lithuania “On the Register of Seagoing Ships of the Republic of Lithuania”. The following ships can be registered at the Register of Seagoing Ships of the Republic of Lithuania (the Register): 1 ...
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 ...
Purchasing a yacht should be a pleasurable experience given that the craft in question is most likely to be used for the owner’s leisure pursuits. Yachts, however, whether they are second-hand, new, large or small, have one thing in common. They are expensive. However, many purchasers whether they are paying £10,000 or £1,000,000 are sometimes less cautious than perhaps they should be when buying what is in effect a “toy” ...
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 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 ...
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 ...
Captains of private and commercial yachts (and owners) have civil and criminal law duties most of which are concerned with the safe operation of the vessel. As the captain is regarded in law as being the owner’s agent, he is the person unfortunately on the spot. It is the captain who becomes personally liable in the first instance for any fine imposed on the vessel. Owners or charterers have no legal obligation to compensate him even though the offence may have occurred due to their fault ...
