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Sughrue Mion client Ottilia Hertel, Kg successfully settles trademark infringement dispute with prior licensee
Ottilia Hertel, Kg. Hertel Interholding, Gmbh, and Hertel Grill Systems, Inc., a privately held German company in the restaurant services, having been unable to resolve its claim against prior licensee, for the unlawful use of Hertel's trademark (large plastic chicken atop of a chicken rotisserie vehicle), came to Sughrue Mion for assistance. Sughrue has previously successfully obtained a registration for the mark. The suit, filed by Hertel against the prior licensee in the U.S. District Court for the Northern District of California, in February 7, 2006, resulted in a significant and positive settlement for Hertel. The settlement culminated in a July 24, 2006 order of the Court entering and approving the settlement agreement, ending the litigation.

08-14-2006

Reiss Answers Medical Staff Legal Advisor Weekly Question
John B. Reiss, Co-Chair of the Health Law Practice Group in the Philadelphia office, answered the August 14, 2006 question of the week for Medical Staff Legal Advisor.

Mr. Reiss provided information for a medical oncology practice facing administrative services issues with a hospital's cancer treatment program.

08-14-2006

“SBA: Federal Prison Industries Not Small For Services”
Government Contracts Group attorney Amy Laderberg O’Sullivan is featured for her comments on a February 2005 decision that will prohibit Federal Prison Industries from winning service contracts intended for small businesses.

08-14-2006

John Baron Named Partner-In-Charge of Alston & Bird's Charlotte Office
John Baron has been named partner-in-charge of Alston & Bird's Charlotte office. In that role, he will oversee daily operations and continue to lead the office's tax group. "We are confident that John's understanding and expertise in the tax and banking and finance arenas, combined with his leadership and business acumen, will allow for the firm to continue to prosper in Charlotte and beyond," says Ben Johnson, managing partner for Alston & Bird.

08-14-2006

New Rules Promote the Adoption of Electronic Prescriptions and Health Information Technology
On August 1, 2006, the Centers for Medicare & Medicaid Services (CMS) and the Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS) issued final rules supporting physician efforts to electronically prescribe medication and electronically document and exchange patient information. Specifically, these rules create new exceptions and safe harbors under the federal physician self-referral and anti-kickback statutes allowing physicians and other providers to accept certain non-monetary compensation related to electronic prescribing and the creation and maintenance of electronic health records without fear of civil or criminal penalties.

A.The CMS Rule

Section 1877 of the Social Security Act, or the Stark Physician Self-Referral Law, prohibits physicians from referring Medicare patients for designated health services to hospitals or other entities in which the physician has a financial interest, unless an exception applies. In 2003, Congress passed the Medicare Prescription Drug, Improvement, and Modernization Act (MMA), which amended the Social Security Act to include Medicare prescription drug benefits. Congress subsequently directed the HHS to establish standards allowing for the electronic prescription of medication in conjunction with the MMA. The MMA also directed the Secretary, in consultation with the Attorney General, to create an exception to the physician self-referral prohibition to permit certain entities to provide non-monetary assistance to physicians to encourage their use of electronic prescribing technology.

In response to this directive, the new CMS rule provides an exception to the physician self-referral law for donated electronic prescribing technology as well as electronic health records software or information technology and training services. The exceptions are contingent upon compliance with several enumerated criteria. For instance, physicians are allowed to receive donated electronic prescribing technology and training services only if they are necessary and used solely to receive and transmit electronic prescription information. Likewise, physicians may only receive donated electronic health records software, information technology, or training services that are necessary and used predominately to create, maintain, transmit, or receive electronic health records. The electronic prescribing technology exception applies only to items and services provided by a hospital to a physician who is a member of its medical staff; by a group practice to a physician who is a member of the group; or by a prescription drug plan sponsor or Medicare Advantage organization to a prescribing physician. The electronic health records exception applies more broadly to items and services provided to a physician by a hospital or other entity that furnishes designated health services.

B.The OIG Rule

Under the anti-kickback statute, it is illegal to knowingly offer, solicit, pay, or receive any compensation to induce or influence referrals to federal health care programs, including Medicare and Medicaid. However, twenty-one safe harbor provisions currently shield certain practices implicated by the anti-kickback statute from civil or criminal prosecution.

The new OIG rule now provides two additional safe harbors for certain arrangements related to electronic prescribing and electronic health records. These safe harbors closely mirror the exceptions outlined under the CMS rule. The first provision creates a safe harbor for the numerous health care entities that provide referring physicians and other health care providers with hardware, software, or other information technology, as well as necessary training services, used solely to communicate electronic prescription information. The second safe harbor provision protects certain arrangements that provide software or information technology and training services used primarily in the creation and transmission of electronic patient records. Like the new Stark II exceptions, each safe harbor has several conditions that must be met to qualify for protection from anti-kickback prosecution.

C.Benefits of the New Rules

In announcing the new CMS and OIG rules, HHS Secretary Michael Leavitt noted that they will ""help doctors provide higher quality patient care, improved efficiency, and with less hassle."" Secretary Leavitt noted that encouraging physicians to electronically transmit prescriptions will enable patients to obtain medication at their choice of pharmacy or ancillary provider. Further, automating the prescription process will improve patient safety and convenience by enabling pharmacists to check for allergies and drug interactions, avoid any confusion caused by hard-to-read physician handwriting, and obtain drug plan information and medication history quickly and accurately.

The exchange of interoperable electronic health records offers many of the same benefits. According to Secretary Leavitt, as health care information becomes more portable, patients will be able to identify and change providers with greater ease and efficiency. Health care costs will also decrease as providers can avoid redundant medical tests as well as errors resulting from illegible charts. The transmission of electronic data also will improve the overall quality of patient care.

The new rules are effective 60 days after publication in the Federal Register on August 8, 2006. The exceptions and safe harbor provisions will sunset on December 31, 2013. For more information, the OIG rule is available at http://www.oig.hhs.gov/authorities/docs/06/OIG%20E-Prescribing%20Final%20Rule%20080806.pdf. The CMC rule is available at http://www.cms.hhs.gov/PhysicianSelfReferral/Downloads/CMS-1303-F.pdf.

08-14-2006

SEC Extends Compliance Deadline For Auditor's Attestation Requirements For Some Foreign Private Issuers; Proposes Other Extensions of Section 404 Implementation
On August 9, 2006, the United States Securities Exchange Commission (the ""SEC"") extended by an additional year the date by which certain foreign private issuers must comply with Section 404(b) of the Sarbanes-Oxley Act of 2002 (""SOX""). Foreign private issuers that are accelerated filers (but not large accelerated filers), and that file their annual reports on Form 20-F or Form 40-F, must now provide an auditor's attestation report on internal control over financial reporting with annual reports filed for fiscal years ending on or after July 15, 2007. The extension does not affect the compliance deadline for the implementation of SOX Section 404(a), which requires management's report on the effectiveness of the issuer's internal control over financial reporting. Management's report must be included with annual reports filed for fiscal years ending on or after July 15, 2006. The extension likewise does not affect the date by which a foreign private issuer that is a large accelerated filer must comply with all of the requirements of SOX Section 404. Foreign private issuers that are large accelerated filers are required to comply with both Section 404(a) and Section 404(b) beginning with annual reports filed for fiscal years ending on or after July 15, 2006.

In a companion release also issued on August 9, 2006, the SEC proposed rules that would extend the dates by which all U.S. and non-U.S. non-accelerated filers would be required to comply with the Section 404(a) management report requirement and the Section 404(b) auditor attestation requirement. The proposed rule would require non-accelerated filers to comply with the management report requirement of Section 404(a) beginning with annual reports filed for fiscal years ending on or after December 15, 2007, and would require such issuers to provide an auditor's attestation report with annual reports filed for fiscal years ending on or after December 15, 2008. The proposed rule also provides that during the first compliance year (i.e., the year in which a management report, but not an auditor's attestation is filed), non-accelerated filers would only be required to ""furnish"" rather than ""file"" management's report. The SEC indicated that if the proposed rules are adopted, they intend to afford similar relief to accelerated foreign private issuers during their first compliance year.

The companion release also proposes to provide transition relief from the Section 404 requirements for newly public companies, including foreign private issuers that list on a U.S. exchange for the first time. The proposed rule would relieve newly public companies of the obligation to provide management's report and an auditor's attestation with their first annual reports. Newly public companies would instead be required to comply with SOX Section 404 beginning with their second annual reports.

This is the SEC's fourth extension of the compliance deadlines related to implementation of SOX Section 404. The SEC stated that its decision to further extend the compliance date was based on the need to provide relief from the ""special burden"" the Section 404 reporting requirements impose on foreign private issuers, smaller companies and newly public companies.

If you have questions concerning this Flash, or United States securities laws generally, please do not hesitate to contact Bonnie Roe on (212) 588-5543, Gerald Shepherd on (212) 588-5540 or Scott Tayne on (212) 588-5520.

08-14-2006

J. Cleve Hill to Serve on Oglethorpe University's National Alumni Board of Directors
J. Cleve Hill, an associate in Powell Goldstein's Bankruptcy and Financial Restructuring Group, is serving a three year term (2005-2008) as a member of the Oglethorpe University National Alumni Board of Directors. In addition to serving on the Board, Mr. Hill serves as a member of the Board's Advancement Committee. Mr. Hill attended the Atlanta, Georgia, liberal arts institution and graduated in 2001.

RELEVANT PRACTICES & INDUSTRIES
Bankruptcy & Financial Restructuring
Bankruptcy Litigation
Representations: Asset Purchases and § 363 Sales
Representations: Committees
Representative Matters: Creditors
Representative Matters: Debtors

08-14-2006

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