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 ...
The rule that a party receiving documents in litigation holds them subject to an implied undertaking to use them only in the proceedings in which they were produced has been a fixture of practice in British Columbia since 1995. However, while the rule is easy to state, it often proves more difficult to apply in practice and carries with it the potential for very serious sanctions for breach ...
On November 21, 2007, the Supreme Court of British Columbia released the decision of Mr. Justice Vickers in Tsilhqot’in Nation v. British Columbia(1). The decision dealt with a claim brought by Chief Roger William of the Xeni Gwet’in First Nation, on behalf of the Xeni Gwet’in First Nation and the Tsilhqot’in Nation ...
Civil Dispute Resolution in TaiwanSeptember, 2007ForewordTaiwan is a civil law jurisdiction, and its courts are charged principally with interpreting statutory laws and have limited ability to create new remedies or laws where there is no statutory basis. Civil, criminal, and administrative cases fall under the jurisdiction of separate court systems. In addition to civil litigation, civil disputes can also be handled through arbitration, mediation, or settlement ...
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 ...
The Federal Circuit, in an opinion written by Judge Rader and joined by Judges Lourie and Prost, has determined that a termination of a contract for the government’s convenience does not terminate obligations to perform warranty and software upgrade services under the contract. The Court of Federal Claims, in a well-reasoned opinion by Judge Miller, had determined otherwise ...
The Arbitration Institute of the Stockholm Chamber of Commerce upholds a strong position as one of the most important centres of international arbitration. The steady growth in the number of cases involving foreign parties that are administered by the Arbitration Institute convincingly demonstrates its worldwide popularity and reputation ...
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 ...
February 2007 UK retail sales rose 0.6% on a like-for-like basis against a weak comparative in February 2006, when sales had fallen. The three-month trend rate of growth weakened in February to 0.9% from 1.1% in January for like-for-like sales, but rose to 4.2% from 3.6% for total sales, reflecting the continued growth of retail space.Clothing and footwear were still difficult but food sales improved, helped by Valentine’s Day, after a flat January ...
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 ...
The U.S. Department of Justice’s revised corporate charging policy, which was named after deputy attorney general Paul McNulty, was unveiled in December 2006. In the wake of its predecessor document, the 2003 Thompson Memo, we have seen a steady increase in the resolution of corporate criminal investigations without indictments or trials ...
Advocate General Sharpston has recently expressed her opinion in the Commission v Republic of Finland case that ensuring a sufficient degree of transparency for the award of sub-threshold procurements should be determined by national law, rather than Community law. If these views were to be followed by the ECJ, it would provide renewed impetus to create national rules on low value awards and represent a meaningful evolution of the ECJ's past case law ...
In our July 2006 legal update, we reported on a ground-breaking agreement (Agreement) signed by the Hong Kong and Mainland China Governments, under which they agreed to recognise and enforce judgments made in each others courts. Legislative changes are now underway in Hong Kong in order to implement the Agreement ...
The Federal Trade Commission yesterday published its long awaited revisions to the FTC’s Franchising Rule. The new disclosures may be used effective July 1, 2007 and must be used for all franchises offered or sold after July 1, 2008. The Amended Rule prescribes a disclosure format which largely mirrors the Uniform Franchise Offering Circular ("UFOC") format, and modifies it in certain places by adding new disclosures ...
Broadband providers will be required to ensure that their ten million UK customers can more easily take advantage of cheaper broadband deals in an increasingly competitive market, under new regulations proposed by the UK communications industry watchdog OFCOM on 17 August 2006 ...
A spectacular smash-up always draws a crowd. In the outsourcing world, where the wreckage is nearly always kept under wraps, that’s even more true. When a problem deal does break into view, it’s always worth watching for lessons in how to manage – or how not to manage – these complex transactions ...
The cause of an action in defamation exists to provide some recourse and remedy to victims of falsehoods which can and do cause injury to reputation. In a classic formulation, recently adopted and approved by Geopel J ...
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 ...
