BCLP Banking Blog

Bank Bryan Cave

Food and Drug Administration

Main Content

September 2010 Client Alerts

September 2010 Client Alerts

October 7, 2010

Authored by: Jeannie Osborne

Check It Out and Check It Off:  2010 and 2011 Group Health Plan Checklist

Several new laws and regulations from 2010 require significant design changes to group health plans and impose new notice requirements on plan sponsors.  For a checklist of the major changes which require implementation in 2010 or 2011 as well as a listing of enrollment and annual notices that group health plan sponsors should consider during open enrollment, please see the Client Alert published by the Employee Benefits & Executive Compensation Client Service Group on September 20, 2010.

New Medicare Enrollment Requirements Will Burden Providers and Suppliers

On September 22, 2010, the Centers for Medicare and Medicaid Services issued proposed rules that will dramatically change the enrollment process for Medicare providers and suppliers, including new enrollment following a change of ownership.  For more information on the new requirements, please read the Client Alert published by the Life Sciences and Health Care Client Service Group on September 22, 2010.

CMS Issues Regulations Changing the DMEPOS Supplier Standards

On August 27, 2010, the Centers for Medicare and Medicaid Services published final regulations in the Federal Register that impose new standards on suppliers of durable medical equipment, prosthetics, orthotics and suppliers.  Most of the requirements contained in the new regulations will take effect on September 27, 2010.  For more information on the regulations, please read the Client Alert published by the Life Sciences and Health Care Client Service Group on September 16, 2010.

Read More

August 2010 Client Bulletins

August 2010 Client Bulletins

September 21, 2010

Authored by: Jeannie Osborne

SEC Adopts Rules Allowing Shareholders Access to Company Proxy Materials

On August 25, 2010, the Securities and Exchange Commission voted to adopt new rules that will require companies to include in their proxy materials nominations for election as directors submitted by eligible shareholders, subject to certain conditions.  For more information, please see the Client Alert published by the Corporate Finance and Securities Client Service Group August 26, 2010.  

Enforcement Landmines for Private Funds in Dodd-Frank

By now, most “private” or “hedge” fund managers know that the Dodd-Frank Wall Street Reform and Consumer Protection Act requires SEC registration of most advisers to private funds, effective July 2011. But SEC registration is not the only aspect of the new law that fund managers need to be aware of. Other provisions of the law will have significant effects on funds.  For more information, please see the Client Alert published by Securities Litigation and Enforcement Alternative Investments Team.

Regulations Issued Under Health Care Reform on Preventive Services and Internal claims and Appeals, and Extended Review Procedures

The Departments of Treasury, Labor and Health & Human Services (the “Departments”) recently issued two more batches of interim final regulations under the Patient Protection and Affordable Care Act as amended (the “Act”).  This new guidance addresses (i) the preventive services coverage mandate, and (ii) the new internal claims and appeals and external review processes.  For more information, please see the Client Alert published by the Employee Benefits and Executive Compensation Group August 5, 2010

USDA to Hold Meeting for Public Input on Codex Processed Fruits and Vegetables Standards

On August 18, 2010, USDA announced a public meeting to provide information and receive comments on agenda items and draft U.S. positions that will be discussed at the 25th Session of the Codex Committee on Processed Fruits and Vegetables.  For more information, please see the August 19, 2010 Food Regulatory and Policy Bulletin published by the Food and Drug Administration Practice

During China Visit, FDA Commissioner’s Focus Not on Heparin Investigation

FDA Commissioner Margaret Hamburg’s recent trip to China focused primarily on avenues of collaboration and cooperation between the FDA and Chinese regulators rather than on the current investigation into the contaminaiton of heparin.  For information on this and other issues, please see the August 27, 2010 Drugs and Devices Regulatory and Policy Bulletin published by the Food and Drug Administration Practice.   

Read More

July 2010 Client Bulletins

July 2010 Client Bulletins

August 2, 2010

Authored by: Jeannie Osborne

President Signs Sweeping Financial Reform Bill:  What our Non-Bank Public Companies Need to Know Now

On July 21, 2010, President Obama signed into law the Dodd-Frank Wall Street Reform and Consumer Protection Act.  Included in the reform legislation — aimed primarily at the reform of financial institutions — are provisions that will apply to all publicly traded companies, including provisions relating to “say on pay” shareholder votes, proxy access, executive compensation disclosure and compensation committees.  For more information on these and other provisions of the Act, please see the Bulletin published by the Corporate Finance and Securities and Employee Benefits Client Service Groups on July 22, 2010.

Private Fund Investment Advisers Registration Act of 2010:  New Law Changes Regulatory Framework for Alternative Investment Managers

On July 21, 2010, President Obama signed into law the financial reform package known as the Dodd-Frank Wall Street Reform and Consumer Protection Act, which contains the Private Fund Investment Advisers Registration Act of 2010 (the “Private Fund Act”).  The Private Fund Act changes the regulatory framework that governs investment advisers managing private fund investments, including private equity funds, hedge funds and certain real estate funds.  For more information on the Private Fund Act, please see the client Alert published by the Alternative Investments Group on July 29, 2010.

Department of Labor Clarifies FMLA Definition of “Son or Daughter,” Confirming Benefit Eligibility of Non-Traditional Families

Under the Family and Medical Leave Act, eligible employees may take up to 12 weeks of job-protected leave upon the birth of a son or daughter, the placement of a son or daughter for adoption or foster care, or to care for a son or daughter with a serious health condition.  Pursuant to the statute, the term “son or daughter” not only includes children with whom a parent has a biological or legal relationship, but the children of individuals standing “in the place of a parent.”  For more information on the clarification of the definition of the term “son or daughter”, please see the client Alert published by the Labor & Employment Client Service Group on July 19, 2010.

Read More

June 2010 Client Bulletins

June 2010 Client Bulletins

July 12, 2010

Authored by: Jeannie Osborne

Regulations Issued on Preexisting Condition Exclusions, Annual and Lifetime Limits, Rescissions and Patient Protections under Health Care Reform

On June 22, 2010, the Departments of Labor, Treasury and Health & Human Services issued regulatory guidance under the Patient Protection and Affordable Care Act regarding prohibitions on preexisting condition exclusions, annual and lifetime limits and rescissions, as well as guidance regarding certain patient protections.  These rules are generally effective for plan years beginning on or after September 23, 2010 (January 1, 2011 for calendar year plans).  For more information on the rules, please see the Bulletin published by the Employee Benefits & Executive Compensation Client Service Group on June 30, 2010.

Grandfathered Plan Regulations Provide Vital Compliance Information for Employer-Sponsored Health Plans

On June 14, 2010, the Departments of Labor, Treasury and Health &  Human Services issued much-anticipated guidance on how a group health plan maintains or loses its status as a grandfathered plan under the Patient Protection and Affordable Care Act.  A grandfathered plan is generally one that was in effect on March 23, 2010.  Because grandfathered plans are exempt from many of the Act’s requirements, maintaining a plan’s grandfathered status has important plan design and cost implications.  Please read the Employee Benefits & Executive Compensation Group’s Bulletin published June 16, 2010, for more information on the interim final regulations.

Supreme Court Expands Time Period for Filing Title VII Disparate Impact Charges

In Lewis v. City of Chicago, the US Supreme Court ruled that the period in which to file an EEOC charge alleging that an employment practice has a disparate impact commences anew whenever that practice is applied, not when that practice was first adopted.  The Lewis decision sharpens the dilemma created by last summer’s Ricci v. DeStefano decision, which held that an employer’s changing an employment practice based on its fear of possible disparate impact claims could be a basis for disparate treatment claims.  For more information on the decision, please see the Labor & Employment Group’s client Alert published June 1, 2010.

Read More

May 2010 Client Alerts

May 2010 Client Alerts

June 9, 2010

Authored by: Jeannie Osborne

Senate Adopts Corporate Finance and Executive Compensation Provisions in Financial Reform Bill

On May 27, the Senate released the text of the financial reform bill that was passed the prior week.  The bill, known as the “Restoring American Financial Stability Act of 2010” or the “Act,” would result in sweeping reforms to the financial industry.  However, it also contains a number of significant provisions that would affect corporate governance and executive compensation at public companies, as well as Regulation D private placements, whistleblowers and beneficial ownership reporting.  This Corporate Finance and Securities Bulletin outlines some of the more important provisions of the Act.

Click here for a complete copy of the Bulletin.

FTC Extends Deadline for Identity Theft Red Flags Rule to December 31, 2010

The Federal Trade Commission announced that it will further delay enforcement of the “Red Flags” Rule through December 31, 2010, while Congress considers legislation that would affect the scope of entities covered by the Rule. The announcement does not affect other federal agencies’ enforcement of the original November 1, 2008 deadline.  As a result, the extension does not apply to banks and other financial institutions that are covered by the Red Flags which were separately issued by the Federal Reserve, FDIC, Treasury Department, or National Credit Union Administration.  This Antitrust, Franchise & Consumer Client Bulletin discusses the announcement.

Click here to read the complete Bulletin.

Agencies Issue Interim Rules on Dependent Health Care Coverage of Children to Age 26

On May 10, the Internal Revenue Service, the Department of Labor and the Department of Health and Human Services jointly issued interim final regulations addressing the provision of dependent coverage of children to age 26 under the Patient Protection and Affordable Care Act, as amended.  

Click here for a copy of the Employee Benefits & Executive Compensation Client Bulletin regarding the new regulations.

Read More

April 2010 Client Alerts

April 2010 Client Alerts

May 1, 2010

Authored by: Jeannie Osborne

IRS Releases Guidance on Tax Treatment of Employer-Provided Health Care Coverage for Children under Age 27.

On April 27 the IRS issued Notice 2010-38 discussing the tax treatment of employer-provided medical care coverage for employees’ adult children up to age 27.  For more information please click here for a copy of the Employee Benefits and Executive Compensation Bulletin which discusses the Patient Protection and Affordable Care Act enacted in late March and outlines the guidance provided in the IRS Notice.

Cobra Premium Subsidy Extended

On April 15 President Obama signed into law H.R. 4851, the Continuing Extension Act of 2010 extending the eligibility period for the COBRA subsidy until May 31, 2010.  For more information, please click here for a copy of the Employee Benefits and Executive Compensation Client Bulletin which provides an overview of the extension provisions and highlights what group health plan sponsors need to know.

Antitrust Agencies Propose New Merger Guidelines

On April 20 the Federal Trade Commission released provisions of the Horizontal Merger Guidelines.  Last updated in 1997, the Proposed Guidelines provide the business community with an overview of how antitrust agencies analyze proposed mergers between competitors.    Click here for a copy of the Antitrust, Franchise & Consumer Law Client Bulletin which outlines the signficant changes proposed to the guidelines.

Read More

March 2010 Client Alerts

March 2010 Client Alerts

April 1, 2010

Authored by: Jeannie Osborne

Third Circuit Rules Secured Lender Not Entitled to Credit Bid at Sale of Collateral Under a Cramdown Plan

On March 22, 2010, the Third Circuit in a split decision joined the Fifth Circuit in holding that a debtor may sell its assets under a plan of reorganization without permitting a secured lender to credit bid by offsetting its secured claim against the purchase price.  This decision may have major implications for secured lenders and may lead to more contested confirmation hearings and litigation over valuation.  For more information, please read the Client Alert published by the Bankruptcy, Restructuring and Creditors’ Rights Client Service Group on March 30, 2010.

Summary of the Federal Reserve Board’s Final Gift Card Rules

On March 23, 2010, the Federal Reserve Board issued its final rule, a summary and analysis of the final rule, and the official staff interpretation of the final rule in connection with Title IV of the CARD Act.  The Final Rules are comparable to the proposed rules that were issued in November, and follow the gift card related provisions set forth in the CARD Act.  For a brief summary of key provisions of the Rules, please read the Client Alert published by the Financial Institutions Client Service Group on March 29, 2010.

Proposed Amendments to the Federal Sentencing Guidelines Emphasize the Importance of Having an Effective and Compliant Records Management Program – What Every Business Needs to Know

In January, the United States Sentencing Commission published proposed changes to the Federal Sentencing Guidelines.  Public hearings on the proposed amendments were held in March.  The Commissioners are to take final action on the proposals in April.  The amendments will be effective in November, unless Congress intervenes.  A major focus of the proposed amendments is on the document retention component of records management.  For a discussion of the proposed changes, please read the Client Alert published by the Records Management Team on March 24, 2010.

Read More

February 2010 Client Alerts

February 2010 Client Alerts

March 1, 2010

Authored by: Jeannie Osborne

SEC Publishes Interpretive Release on Climate Change Matters

Yesterday, the SEC published its interpretative release regarding disclosure requirements applicable to climate change matters. The release provides guidance on certain existing disclosure rules that may require a company to disclose the impact that business or legal developments related to climate change may have on its business.

For more information, please read the client alert published by Bryan Cave LLP’s Corporate Finance and Securities practice on February 3, 2010.

SEC Amends E-Proxy Rules to Provide Increased Flexibility

Yesterday the SEC approved amendments to the notice and access proxy, or “e-proxy,” rules.  The amendments will provide increased flexibility for companies regarding the format and content of the notice.

For more information, please read the client alert published by Bryan Cave LLP’s Corporate Finance and Securities practice on February 23, 2010.

Federal Judge Rules that Data Backup Tapes Need not be Retained for eDiscovery, Unless They are the Sole Source of Relevant Evidence

Federal Judge Shira Scheindlin of the Southern District of New York has ruled that it is not necessary for the litigants in a case now pending before her to retain and preserve all data backup tapes for eDiscovery:  “I am not requiring that all backup tapes must be preserved.  Rather, if such tapes are the sole source of relevant information (e.g., the active files of key players are no longer available), then such backup tapes should be segregated and preserved.”

For more information, please read the client alert published by Bryan Cave LLP’s Records Management team on February 9, 2010.

Read More

January 2010 Client Alerts

January 2010 Client Alerts

February 5, 2010

Authored by: Jeannie Osborne

IRS Announces New Section 409A Document Correction Program

Section 409A of the Internal Revenue Code of 1986, as amended (“Code Section 409A”) is spectacular in scope and notoriously difficult for even the most well-intentioned employers to satisfy.  Any employer which maintains non-qualified deferred compensation plans for its employees has struggled with Code Section 409A, and may have concerns that some of its plans might not satisfy the attention to minutiae that Code Section 409A demands.  On January 4, the IRS published its long-awaited program for correcting documentation failures under Code Section 409A.

For more information, please read the client alert published by Bryan Cave LLP’s Employee Benefits and Executive Compensation Practice on January 22, 2010.

Major Campaign Finance Development – Citizens United v. FEC Supreme Court Ruling

The Supreme Court yesterday handed down a landmark ruling in the Citizens United v. FEC case which could significantly transform the campaign finance system at the federal level.  In Citizens United, the Supreme Court in a 5-4 ruling struck down the decades-old prohibition on corporate expenditures in connection with federal elections as unconstitutional under the First Amendment.

For more information, please read the client alert published by Bryan Cave LLP’s Election Law and Government Ethics Practice on January 22, 2010. 

Read More

December 2009 Client Alerts

December 2009 Client Alerts

January 12, 2010

Authored by: Jeannie Osborne

SEC Approves Rule Changes Regarding Executive Compensation and Corporate Governance

On December 16, 2009, the SEC approved rule changes that would expand proxy statement disclosures relating to executive compensation and corporate governance. Additionally, Chairman Shapiro confirmed that the SEC expects to act on the controversial proxy access proposal (which was discussed in a June 22 Client Bulletin) in early 2010.

For more information, please read the client alert published by Bryan Cave LLP’s Corporate Finance and Securities Client Service Group on December 17, 2009.

Preparing for the 2010 Proxy Season

As public companies turn their attention to the preparation of their annual reports and proxy materials, we want to highlight several developments for the 2010 season.

For more information, please read the client alert published by Bryan Cave LLP’s Corporate Finance and Securities Client Service Group published December 8, 2009.

New (Temporary) 50% Bank Payroll Tax in The United Kingdom

The Government announced yesterday that between December 9, 2009 and April 5, 2010, the award of bonuses to bank employees will render the bank liable to a new “bank payroll tax”.

For more information, please read the client alert published by Bryan Cave LLP’s Tax Advice and Controversy Client Service Group (London) on December 10, 2009.

Read More
The attorneys of Bryan Cave Leighton Paisner make this site available to you only for the educational purposes of imparting general information and a general understanding of the law. This site does not offer specific legal advice. Your use of this site does not create an attorney-client relationship between you and Bryan Cave LLP or any of its attorneys. Do not use this site as a substitute for specific legal advice from a licensed attorney. Much of the information on this site is based upon preliminary discussions in the absence of definitive advice or policy statements and therefore may change as soon as more definitive advice is available. Please review our full disclaimer.