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![]() | FDA Schedules Public Hearing on the Use of the Internet and Social Media in the Promotion of FDA-Regulated Products
November 9, 2009, previously published on October 26, 2009 The United States Food and Drug Administration (FDA) has issued a notice of public hearing and request for comments to discuss issues related to the promotion of FDA-regulated products (e.g., prescription drugs, prescription biologics and medical devices) using the Internet and social media tools.... |
![]() | Massachusetts Supreme Court Holds that Asymptomatic Plaintiffs May Sue for Medical Monitoring
November 9, 2009, previously published on November 4, 2009 In a recent opinion that bucks the national trend, the Massachusetts Supreme Judicial Court authorized plaintiffs who have no manifest physical injuries, but who assert "subcellular changes" caused by cigarette smoking, to sue for medical monitoring. , 914 N.E.2d 891 (Mass. 2009). |
![]() | Entities Billing for Physicians Need to Check Criminal Histories, Based on Authority of CMS to Revoke Billing Privileges Retroactively for Certain Criminal Convictions
November 6, 2009, previously published on November 2, 2009 Revocation of billing privileges is a relatively new enforcement tool being used by the Centers for Medicare & Medicaid Services (CMS). Based on the authority of CMS to revoke billing privileges based on certain criminal convictions occurring in the 10 years preceding enrollment or... |
![]() | Manual Revisions for Inpatient Rehabilitation Facilities
November 6, 2009, previously published on November 2, 2009 The Centers for Medicare & Medicaid Services (CMS) has published revised manual provisions in the Benefits Policy Manual regarding inpatient rehabilitation facility (IRF) coverage requirements. These coverage revisions are based on the new IRF requirements adopted by CMS in the FY 2010 final... |
![]() | Decision to Terminate Benefits Upheld because of Principled Decision-Making Process
November 6, 2009, previously published on October 2009 Charles McDonald ("McDonald"), former Constellation Energy Group employee, claimed that he was unable to perform his duties as supervisor of distributions operations, due to tremors in his left arm, which were later determined to be related to McDonald's emotional state. Specifically,... |
![]() | Anti-Tort Reform Goodies Buried in Health Care Bill
November 6, 2009, previously published on October 30, 2009 The House version of the health care bill, titled "Affordable Health Care for America Act," includes a section (pgs. 1431-33) for incentive payments to be made to each State that has a compliant alternative medical liability law. |
![]() | Clinical Investigator Responsibilities -- Protecting the Rights, Safety and Welfare of Study Subjects
November 6, 2009, previously published on November 5, 2009 The Food and Drug Administration (FDA) posted a final guidance in October 2009 to clarify the responsibilities of investigators in conducting clinical trials of drugs, biological products and medical devices. The final guidance reiterates the scope of responsibilities set forth in a May 2007 draft... |
![]() | FDA Holds Second Transparency Task Force Public Meeting Including Issues Related to Disclosure of Clinical Trial Data November 6, 2009, previously published on November 5, 2009 On November 3, the U.S. Food and Drug Administration's (FDA or Agency) Transparency Task Force held its second public meeting. Principal Deputy Commissioner and Task Force leader Joshua Sharfstein stated that the Task Force's goal is to draft recommendations for FDA Commissioner Margaret Hamburg... |
![]() | Health Care Reform: More Aggressive Fraud Enforcement and Broader Government Oversight are on the Horizon
Douglas W. Baruch, John T. Boese, Beth C. McClain; Fried, Frank, Harris, Shriver & Jacobson LLP; November 5, 2009, previously published on November 5, 2009 Much of the current debate surrounding health care reform has focused on entitlements and the mechanisms for paying for them. Less attention is being paid to important provisions in pending House and Senate bills that would...Make it significantly easier for the government to prove certain health... |
![]() | Employers Offering Health Benefits Can No Longer Ignore HIPAA
Drinker Biddle & Reath LLP; November 5, 2009, previously published on November 5, 2009 If you are an employer offering health insurance to your employees (a Health Plan Sponsor), you know that your group health plan (including any medical, dental, vision and health FSA benefits) is considered a "covered entity" under the HIPAA privacy and security rules. For many of you who... |







