Health Care Compliance and Enforcement Update

Key Legal Developments Affecting the Health Care Industry—Fourth Quarter 2011

This issue of the Jones Day Health Care Compliance and Enforcement Update covers judicial, legislative, and regulatory matters affecting health care entities, along with other important developments in the last quarter of 2011.

In this issue:

Judicial Developments

"Par Pharmaceutical Seeks Declaratory Judgment that First Amendment and FDCA Bar Enforcement of FDA Regulations Regarding Manufacturers' Speech"
"'False Certification' Continues to be an Elusive Concept in False Claims Act Cases"

Developments Involving Individuals

"Synthes Executives Sentenced to Prison Terms for Strict Liability Misdemeanor Violation of FDCA"
"Former Purdue Executives Appeal Exclusion; Decision Pending"
"Former InterMune CEO Appeals Conviction and Exclusion"
"DOJ-HHS Medicare Strike Force Charges 91 Individuals in Eight Cities"

Agency Developments

"DOJ Recovers More Than $3 Billion in False Claims Act Cases"
"OIG Issues Its Fall 2011 Semiannual Report to Congress"
"OIG Issues FY 2012 Work Plan"
"CMS Implements Fraud Prevention System to Identify Potentially Fraudulent Medicare Claims"
"CMS Announces Demonstration Projects to Reduce Improper Payments"
"FDA Provides Draft Guidance and Seeks Comments on Issues Related to Off-Label Uses"
"CMS Announces $9 Million Grant to Senior Medicare Patrol Program"

Regulatory and Legislative Developments

"CMS Releases Its Final Rule Regarding the Implementation of Medicaid Recovery Audit Contractor Programs"
"OIG Advises Connecticut and Iowa that Their False Claims Laws Meet the Requirements to Receive an Additional Share in Recovery"
"Senate Considers 'Medical Device Patient Safety Act'"
"CMS Releases Proposed Rule for Physician Payments 'Sunshine' Act"
"House Holds Hearings on Bill to Simplify Criminal Code"
"CMS Issues Final Rule for Medicare Accountable Care Organizations"

Developments Involving Manufacturers and Providers

International Developments

"European Union Court of Justice Rules that Stem Cell-Related Inventions Are Not Patentable"
"U.K. National Information Governance Board Releases Information Guidance for Health Care Entities"
"France Adopts Transparency Rule for Health Care Companies"

Jones Day News

"DOJ Health Care Chief and Former FCPA Assistant Chief Joins Jones Day"
"Jones Day Expands Investigations Practice with Major Hires in U.S. and U.K."