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Duane Morris LLP Chicago, IL Document Search Results (19) Show: results per page Sort by:  | CMS Delays Data Collection Under ACA's Physician Payments Sunshine Act to January 1, 2013
Frederick R. Ball, Elinor L. Hart; Duane Morris LLP;
Legal Alert/Article May 10, 2012, previously published on May 9, 2012 On May 3, 2012, the Centers for Medicare and Medicaid Services (CMS) officially announced that it will delay data-collection and reporting requirements under the Patient Protection and Affordable Care Act's (ACA) Physician Payments Sunshine Act (the "Sunshine Act"), due in part to the...
| | FDA Issues Draft Guidance on Affordable Care Act Prescription Drug Sample Transparency Program: Reporting Deadline Informally Extended to October 1, 2012
Frederick R. Ball, Elinor L. Hart; Duane Morris LLP;
Legal Alert/Article April 9, 2012, previously published on April 4, 2012 On April 3, 2012, the U.S. Food and Drug Administration (FDA) published notice of a Draft Guidance detailing its current compliance policy for the Patient Protection and Affordable Care Act's (ACA) Prescription Drug Sample Transparency program (the "Program"). As detailed in an earlier...
| | HHS Releases Final Rule and Interim Final Rules on Affordable Care Act's State Health Insurance Exchanges
C. Mitchell Goldman, Elinor L. Hart, Melissa Sobel Snyder; Duane Morris LLP;
Legal Alert/Article March 20, 2012, previously published on March 14, 2012 On March 12, 2012, the U.S. Department of Health and Human Services (HHS) released the long-anticipated Final Rule and Interim Final Rules (the "Rules") on the Patient Protection and Affordable Care Act's (ACA) state health insurance exchanges ("Exchange(s)"), a key element of...
| | Supreme Court Addresses Whether Supremacy Clause Provides Private Right of Action to Challenge Medicaid Cuts in Douglas v. Independent Living Center
Frederick R. Ball, Erin M. Duffy; Duane Morris LLP;
Legal Alert/Article March 14, 2012, previously published on March 12, 2012 Representing the latest decision involving Medicaid providers' attempts to judicially combat cuts to Medicaid reimbursement, on February 22, 2012, the U.S. Supreme Court handed down a five-to-four decision in Douglas v. Independent Living Center of Southern California ("Douglas"). At...
| | Centers for Medicare and Medicaid Services Releases Proposed Rule on Reporting and Returning of Overpayments
Frederick R. Ball, Elinor L. Hart; Duane Morris LLP;
Legal Alert/Article March 13, 2012, previously published on March 8, 2012 The U.S. Centers for Medicare and Medicaid Services (CMS) released a long-anticipated proposed rule on reporting and returning of overpayments on February 16, 2012. The proposed rule is part of CMS's recent effort to respond to increased Medicare spending through expanded efforts to reduce fraud,...
| | FDA Issues Draft Guidance for Notification of Issues That May Result in Prescription Drug Shortage
Frederick R. Ball; Duane Morris LLP;
Legal Alert/Article March 6, 2012, previously published on March 1, 2012 On February 27, 2012, the U.S. Food and Drug Administration (FDA) issued a draft guidance encouraging manufacturers of prescription drug and biologic products to voluntarily notify FDA of issues that may result in a shortage of the product in the U.S. market or potential disruption in the supply.
| | FDA Issues Proposed Rule Regarding Citizen Petitions and PSAs Related to Section 505(b)(2) Applications or ANDAs
Frederick R. Ball; Duane Morris LLP;
Legal Alert/Article January 6, 2012, previously published on January 4, 2012 As part of the Food and Drug Administration Amendments Act of 2007 (FDAAA) enacted on September 27, 2007, Congress added Section 505(q) to the federal Food, Drug and Cosmetic Act (FDCA) (21 U.S.C. § 355(q)). Section 505(q) applied to certain citizen petitions and petitions for stay of action...
| | Illinois Broadens the Standards for Enforcing Restrictive Covenants in Illinois
Frederick R. Ball, Ana D. Petrovic, Jon Zimring; Duane Morris LLP;
Legal Alert/Article December 9, 2011, previously published on December 6, 2011 In recent years, employers and employees have not had consistent guidance on when an Illinois court would enforce restrictive covenants. If an employer sued a former employee in Cook County, Ill., then the employer had to initially establish that the restrictive covenant was necessary to protect...
| | Illinois Decision on Lien Priorities
Jeffrey L. Hamera; Duane Morris LLP;
Legal Alert/Article November 21, 2011, previously published on November 16, 2011 The Illinois Supreme Court in La Salle Bank N.A. v. Cypress Creek 1, LP has issued an opinion clarifying the relative priorities of a lender and mechanic's lien claimants to the proceeds of a foreclosure sale where the lender's mortgage was recorded before the mechanic's liens attached. The only...
| | FTC Steps Up Enforcement on Health-Related Claims in Advertising
Frederick R. Ball, Erin M. Duffy; Duane Morris LLP;
Legal Alert/Article November 8, 2011, previously published on October 28, 2011 In a recent settlement with Reebok, the U.S. Federal Trade Commission (FTC) clarified that it will impose substantial penalties, including restitution to consumers, on companies that make health-related claims without an adequate basis. Moreover, in the consent decree, the FTC stated exactly what...
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