2012 Hot Topics

Date Title
25-Jan-12

Health and Nutrition Claims: Italy’s Ministry of Health Issues Guidelines on Probiotics

Author(s): Massimiliano Russo
Practice Areas & Industries: Health , Italy

2011 Hot Topics

Date Title
11-Oct-11

Health Care Insurance Companies in Italy Fined Over €13 Million for Anti-Competitive Behaviour

Author(s): Veronica Pinotti
Practice Areas & Industries: Antitrust & Competition , EU Competition and Regulatory - Italy , Health , Italy

30-Sep-11

New October 15 Deadline for Medicare Part D Creditable / Non-Creditable Coverage Notices

Author(s): Susan M. Nash , Elizabeth A. Savard
Practice Areas & Industries: Employee Benefits , Health

23-Jun-11

Guidance Regarding Annual Waiver Application Deadline

Author(s): Susan M. Nash , Maureen O'Brien
Practice Areas & Industries: Employee Benefits , Health

21-Apr-11

New Responsible Corporate Officer; Obstruction Developments

Author(s): Joshua T. Buchman , James S. Cohen , Michael W. Peregrine
Practice Areas & Industries: FDA - Life Sciences , Health , Life Sciences - Health

24-Mar-11

EU Pharma Law Developments: EU Clinical Trials Register Launched Online

Author(s): Stephan Rau , Massimiliano Russo
Practice Areas & Industries: Germany , Health , Italy , Life Sciences & Medical Products

21-Mar-11

U.S. Department of Labor Releases New Guidance Further Delaying Enforcement for Health Care Reform Appeals Rules

Author(s): Amy M. Gordon , Michael T. Graham , Susan M. Nash , Jamie A. Weyeneth
Practice Areas & Industries: Employee Benefits , Health

02-Mar-11

EU Commission Launches Public Consultation: Concept Paper on Revision of Clinical Trials Directive 2001/20/EC

Author(s): Massimiliano Russo
Practice Areas & Industries: Corporate , Health , Intellectual Property , Italy , Life Sciences & Medical Products , White-Collar & Securities Defense

02-Mar-11

EU Parliament Adopts New Falsified Medicines Directive

Author(s): Massimiliano Russo
Practice Areas & Industries: Corporate , Health , Intellectual Property , Italy , Life Sciences & Medical Products , White-Collar & Securities Defense

08-Feb-11

Italy—Authorisation for Genetic Data Processing in Clinical Studies Extended Until June 30, 2011, by the Authority

Author(s): Massimiliano Russo
Practice Areas & Industries: Health , Health Information Privacy , Italy , Privacy and Data Protection

2010 Hot Topics

Date Title
28-Dec-10

IRS Releases Two New Important Pieces Of Executive Compensation Guidance Related To Health Care Reform

Author(s): Joseph S. Adams , Jonathan J. Boyles , Andrew C. Liazos
Practice Areas & Industries: Employee Benefits , Health

13-Dec-10

Virginia Federal Judge Rules on Constitutionality of U.S. Health Care Reform Law

Author(s): Stephen W. Bernstein , Gary Scott Davis , Christopher M. Jedrey , Michael W. Peregrine , J. Peter Rich , Eric Zimmerman
Practice Areas & Industries: Health , Health Care Law Reform

02-Dec-10

CMS to Postpone Denying Claims When Ordering/Referring Provider not Enrolled in PECOS

Author(s): Eric B. Gordon M.D. , Peter R. Leone , Joan Polacheck , Monica Wallace
Practice Areas & Industries: Health , Managed Care

23-Nov-10

CMS Announces Medicare ASC Payment Updates for 2011

Author(s): Gary B. Gertler , Christopher M. Jedrey , Jerry J. Sokol , Eric Zimmerman
Practice Areas & Industries: Ambulatory Surgery Centers (ASC) , Health

21-Sep-10

U.S. Departments of Health and Human Services, Labor and Treasury Release New Guidance on Health Care Reform Requirements

Author(s): Amy M. Gordon , Susan M. Nash , Elizabeth A. Savard , Jamie A. Weyeneth
Practice Areas & Industries: Employee Benefits , Health

31-Aug-10

Update on the Early Retiree Reinsurance Program

Author(s): Amy M. Gordon , Susan M. Nash
Practice Areas & Industries: Employee Benefits , Health

29-Jun-10

Health Care Reform: Early Retiree Reinsurance Program Application is Now Available

Author(s): Amy M. Gordon , David E. Rogers , Jamie A. Weyeneth
Practice Areas & Industries: Employee Benefits , Health , Health Care Law Reform , Labor & Employment

15-Jun-10

Health Care Reform: Agencies Clarify that Health Care Reform Requirements Should Not Apply to Retiree-Only Plans

Author(s): Amy M. Gordon , Susan M. Nash , Jamie A. Weyeneth
Practice Areas & Industries: Employee Benefits , Health , Health Care Law Reform

03-Jun-10

CMS Offers Section 111 Direct Data Entry Option for Self-Insured Hospitals and Captive Insurers

Author(s): James W. Kim , Joan Polacheck
Practice Areas & Industries: Health

02-Jun-10

Health Care Reform: Early Retiree Reinsurance Program Draft Application Released

Author(s): Amy M. Gordon , Joanna C. Kerpen
Practice Areas & Industries: Employee Benefits , Health , Health Care Law Reform , Reimbursement/Fraud & Abuse

11-Mar-10

EFSA Public Consultation on Draft Guidance Document for Environmental Risk Assessment of GM Plants

Author(s): Massimiliano Russo
Practice Areas & Industries: Health , International Environmental , Italy

01-Mar-10

CMS Delays Medicare Secondary Payer Reporting for Hospitals and Captive Insurers

Author(s): James W. Kim , Joan Polacheck
Practice Areas & Industries: Government Strategies , Health , Health Care Industry Captive Insurance , Managed Care

2009 Hot Topics

Date Title
16-Jul-09

CMS to Clarify Captive Insurance and Hospital Medicare Secondary Payer Reporting Requirements

Author(s): James W. Kim , Joan Polacheck
Practice Areas & Industries: Captive Insurance and Reinsurance , Health

13-Jul-09

CMS Releases Proposed 2010 Medicare Physician Fee Schedule Update

Author(s): Daniel F. Gottlieb , Daniel H. Melvin , Joan Polacheck
Practice Areas & Industries: Health

10-Jul-09

Ambulatory Surgery Center Payment Updates

Author(s): Eric Zimmerman
Practice Areas & Industries: Ambulatory Surgery Centers (ASC) , Health

09-Jul-09

EFSA Gives Positive Opinion on Picolinate Forms of Minerals for Food Supplements

Author(s): Massimiliano Russo
Practice Areas & Industries: Health , Italy

14-May-09

CMS Issues Extension of Mandatory Insurance Reporting and Registration Deadlines

Author(s): James W. Kim , Joan Polacheck
Practice Areas & Industries: Health , Health Care Industry Captive Insurance

31-Mar-09

CMS Issues Final CY 2010 Call Letter for Medicare Advantage and Medicare Part D Programs

Author(s): Ankur J. Goel , Anne W. Hance , Joel L. Michaels
Practice Areas & Industries: Health , Managed Care

27-Mar-09

Public Consultation on the Data Protection Authority's Draft Guidelines for Electronic Health Records

Author(s): Massimiliano Russo
Practice Areas & Industries: Health , Italy

24-Feb-09

CMS Re-Issues Draft CY 2010 Call Letter for Medicare Advantage and Part D

Author(s): Ankur J. Goel , Anne W. Hance , Joel L. Michaels
Practice Areas & Industries: Health

23-Feb-09

IRS Issues Revised Form 941 and Instructions for COBRA Premium Subsidy

Author(s): Amy M. Gordon , Susan M. Nash
Practice Areas & Industries: Benefits Plan Compliance , Employee Benefits , Health , Health and Welfare Benefit Plans

07-Jan-09

CMS Issues New Rules for Medicare Advantage, Part D, Retiree Drug Subsidy Programs

Author(s): Ankur J. Goel , Anne W. Hance , Joel L. Michaels
Practice Areas & Industries: Health , Reimbursement/Fraud & Abuse

2008 Hot Topics

Date Title
18-Nov-08

Tax Exempt Employers: December 31 Deadline Approaching for 403(b) Plans

Author(s): Jonathan J. Boyles , Ralph E. DeJong
Practice Areas & Industries: Employee Benefits , Health , Non-Qualified Deferred Compensation

10-Nov-08

CMS Issues Additional Final Rule On Agent/Broker Compensation for Medicare Advantage and Part D Programs

Author(s): Ankur J. Goel , Anne W. Hance , Joel L. Michaels
Practice Areas & Industries: Health , Managed Care

23-Oct-08

FTC Delays Enforcement of Identity Theft Red Flag Rule until May 1, 2009

Author(s): Stephen W. Bernstein
Practice Areas & Industries: Health , Health - Information Systems

15-Sep-08

CMS Issues Final Rules Addressing Medicare Marketing, Among Other Medicare Advantage and Part D Program Changes

Author(s): Ankur J. Goel , Anne W. Hance , Joel L. Michaels
Practice Areas & Industries: Health

28-Aug-08

Justice Department Modifies Policies on Assessing Cooperation by Corporations

Author(s): Ankur J. Goel
Practice Areas & Industries: Health , Trial , White-Collar & Securities Defense

10-Jun-08

Supreme Court Decision and Pending Legislation Focus on False Claims Act

Author(s): Ankur J. Goel , Russell Hayman
Practice Areas & Industries: Health

30-May-08

NABP Names 79 Internet Drug Outlets Conflicting with Patient Safety and Pharmacy Practice Standards

Author(s): T. Reed Stephens
Practice Areas & Industries: Health , Life Sciences & Medical Products

17-Apr-08

CMS Releases Final Part D Technical Rule

Author(s): Ankur J. Goel , Anne W. Hance , Joel L. Michaels
Practice Areas & Industries: Health

17-Apr-08

Medicaid Tamper-Resistant Prescription Pad Law Now in Effect

Author(s): T. Reed Stephens
Practice Areas & Industries: Health

17-Jan-08

CMS Releases Draft "Call Letter" for Medicare Advantage and Medicare Part D

Author(s): Ankur J. Goel , Anne W. Hance , Joel L. Michaels
Practice Areas & Industries: Health

16-Jan-08

CMS Issues Final Rule Addressing Protected Classes of Part D Drugs

Author(s): Ankur J. Goel , Anne W. Hance , Joel L. Michaels
Practice Areas & Industries: Health , Reimbursement/Fraud & Abuse

2007 Hot Topics

Date Title
20-Dec-07

IRS Releases Revamped Form 990 for Tax-Exempt Organizations

Author(s): Ralph E. DeJong , Christopher M. Jedrey , Robert C. Louthian III , Michael W. Peregrine
Practice Areas & Industries: Health , Tax Exemption

03-Dec-07

CMS Broadens Compliance Obligations Under Medicare Advantage and Medicare Part D

Author(s): Ankur J. Goel , Anne W. Hance , Joel L. Michaels
Practice Areas & Industries: Health

14-Nov-07

Moody's Sharpens Focus on Board Oversight of Investment Management

Author(s): Christopher M. Jedrey , Michael W. Peregrine
Practice Areas & Industries: Health , Tax Exemption

18-Oct-07

New Panel on the Nonprofit Sector Guidance Suggests Emerging Governance Best Practices

Author(s): Ralph E. DeJong , Michael W. Peregrine
Practice Areas & Industries: Corporate Responsibility and Governance , Health

14-Jun-07

IRS Releases "Extreme Makeover" of Form 990 Return for Exempt Organizations

Author(s): Ralph E. DeJong , Robert C. Louthian III
Practice Areas & Industries: Health , Tax Exemption

11-May-07

New IRS Guidance on EHR Technology Donation to Physicians

Author(s): Bernadette M. Broccolo , Robert C. Louthian III
Practice Areas & Industries: Health , Health - Information Systems , Tax Exemption

20-Apr-07

CMS Releases Final 2008 "Call Letter" For Medicare Advantage and Medicare Part D

Author(s): Anne W. Hance , Joel L. Michaels
Practice Areas & Industries: Health , Managed Care

13-Apr-07

CMS Proposes New National Coverage Determination on Clinical Trial Policy

Author(s): Jennifer S. Geetter
Practice Areas & Industries: Health , Life Sciences & Medical Products , Products Outcomes Research , Reimbursement/Fraud & Abuse

23-Mar-07

CMS Releases Draft 2008 "Call Letter" For Medicare Advantage and Medicare Part D

Author(s): Anne W. Hance , Joel L. Michaels
Practice Areas & Industries: Health , Health - Product Regulation

05-Feb-07

IRS Releases Suggested Governance Guidelines for Tax-Exempt Organizations

Author(s): Bernadette M. Broccolo , Ralph E. DeJong , Peter L. Faber , Christopher M. Jedrey , Robert C. Louthian III , Michael W. Peregrine
Practice Areas & Industries: Health , Tax Exemption

2006 Hot Topics

Date Title
01-Sep-06

CMS Revises EMTALA Regulation Regarding Physician Certification of False Labor

Author(s): Charles Buck , H. Guy Collier , Sandra M. DiVarco , Kerrin B. Slattery
Practice Areas & Industries: Health

23-Aug-06

President Bush signs Executive Order promoting Quality and Efficient Health Care through Use of Health Information Technology

Author(s): Stephen W. Bernstein , Bernadette M. Broccolo
Practice Areas & Industries: Health , Health - Information Systems

02-Aug-06

Update on Federal Health IT Bill: Protection For Certain Hospital/Physician Health IT Arrangements

Author(s): Stephen W. Bernstein , Bernadette M. Broccolo
Practice Areas & Industries: Health , Health - Information Systems

26-Jul-06

CMS Publishes Final 2007 Marketing Guidelines for Medicare Parts C and D

Author(s): Anne W. Hance , Joel L. Michaels
Practice Areas & Industries: Health , Managed Care

02-Jun-06

Federal Bill on Health Information Technology on the Move; Protection for Certain Hospital/Physician Health IT Arrangements

Author(s): Bernadette M. Broccolo , Eric B. Gordon M.D. , Daniel H. Melvin
Practice Areas & Industries: Health , Health - Information Systems

26-Apr-06

CMS Publishes Final Compliance Guidance for Medicare Part D

Author(s): Ankur J. Goel , Anne W. Hance , Joel L. Michaels
Practice Areas & Industries: Health , Managed Care

23-Mar-06

Illinois Attorney General Not Pursuing Tax-Exempt Hospital Responsibility Act in Current Session

Author(s): Michael F. Anthony , Bernadette M. Broccolo
Practice Areas & Industries: Health , Tax Exemption

14-Feb-06

CMS Publishes Draft Medicare Part D Compliance Guidance for Comment

Author(s): Ankur J. Goel , Anne W. Hance , Joel L. Michaels
Practice Areas & Industries: Health , Managed Care

2005 Hot Topics

Date Title
29-Nov-05

Draft OIG Compliance Program Guidance for Recipients of PHS Research Awards

Author(s): Bernadette M. Broccolo , Jennifer S. Geetter
Practice Areas & Industries: Health , Life Sciences - Health

16-Nov-05

Federal Nonprofit Oversight Legislation Begins to Emerge; Contains Provisions Affecting Hospitals and Health Systems

Author(s): Robert C. Louthian III , Michael W. Peregrine
Practice Areas & Industries: Health

08-Aug-05

CMS to Publish Final Annual Update to Hospital Inpatient PPS

Author(s): Eric Zimmerman
Practice Areas & Industries: Academic Medical Centers , Health , Health - Sub-acute/Long-Term Care

12-May-05

New Bill Aims to Permanently Ban Physician Referrals to Specialty Hospitals

Author(s): Eric Zimmerman
Practice Areas & Industries: Health

02-May-05

CMS Ruling Reverses Previous Proposal to Delete 100 Medicare Procedures from ASC List

Author(s): Eric Zimmerman
Practice Areas & Industries: Ambulatory Surgery Centers (ASC) , Health , Health Ventures/Physician Transactions , Reimbursement/Fraud & Abuse

14-Apr-05

CMS to Use Recovery Audit Contractors to Identify Medicare Overpayments

Author(s): Eric Zimmerman
Practice Areas & Industries: Health , Reimbursement/Fraud & Abuse

08-Mar-05

MedPAC Specialty Hospital Report

Author(s): Eric Zimmerman
Practice Areas & Industries: Health , Health - General Counsel , Health Ventures/Physician Transactions , Reimbursement/Fraud & Abuse

21-Jan-05

CMS Releases Final Medicare Regulations

Author(s): Ankur J. Goel , Joel L. Michaels
Practice Areas & Industries: Health , Health Ventures/Physician Transactions

2004 Hot Topics

Date Title
12-Nov-04

New Sentencing Guideline Amendments Require Compliance Assessment

Author(s): Ankur J. Goel , Russell Hayman , Michael W. Peregrine
Practice Areas & Industries: Health , Health - General Counsel

13-Oct-04

Non-Qualified Deferred Compensation Legislation To Effect Tax-Exempt Employers

Author(s): Ralph E. DeJong , Andrew C. Liazos
Practice Areas & Industries: Executive Compensation , Health , Health - General Counsel , Tax Exemption

11-Aug-04

IRS Initiative on Tax-Exempt Organizations' Executive Compensation

Author(s): Ralph E. DeJong , Andrew C. Liazos , Michael W. Peregrine
Practice Areas & Industries: Executive Compensation , Health , Health - General Counsel , Tax Exemption

10-Aug-04

NY State Attorney General Sues Health Insurer and PBM Over Management of Pharmacy Benefits

Author(s): Ankur J. Goel
Practice Areas & Industries: Health , Health - General Counsel , Health Care Litigation , Insurance

02-Jul-04

New OIG/AHLA Educational Resource for Board Members Released

Author(s): Michael W. Peregrine
Practice Areas & Industries: Corporate Responsibility and Governance , Health , Health - General Counsel

20-Jan-04

Increased U.S. Scrutiny of Clinical Research Contracts

Author(s): Jennifer S. Geetter , Christopher M. Jedrey
Practice Areas & Industries: Academic Medical Centers , Health , Health - General Counsel , Health - Product Regulation , HIPAA

2003 Hot Topics

Date Title
28-Oct-03

Pro Bono Report Features Health Lawyers

Author(s): Donald B. Hilliker , Christopher M. Jedrey
Practice Areas & Industries: Health

McDermott Will & Emery

McDermott Will and Emery