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Foley Hoag LLP Washington, DC Document Search Results (6) Sort by:  | Enforcing Medicaid’s Entitlement Still Uncertain in the Wake of the Supreme Court’s Douglas Decision
Thomas Barker, Maia M. Larsson, Ross Margulies; Foley Hoag LLP;
Legal Alert/Article March 12, 2012, previously published on March 6, 2012 The Medicaid statute begins with seven words: “A state plan for medical assistance must,” and the statute then proceeds to list 83 requirements that a state Medicaid plan is required to meet. Absent from the statute, however, is any remedy for Medicaid beneficiaries or providers who are...
| | HHS-DOL-Treasury Summary of Benefits and Coverage and Uniform Glossary Final Rule | Summary
Thomas Barker, Maia M. Larsson; Foley Hoag LLP;
Legal Alert/Article February 13, 2012, previously published on February 10, 2012 Section 2715 of the Public Health Service Act (PHS Act), which was enacted as part of the Patient Protection and Affordable Care Act (also referred to as PPACA, the Affordable Care Act, or the ACA), requires health insurers and group health plans offering health care coverage to enrollees and...
| | FDA Releases Long-Awaited Draft Guidances on Biosimilar Product Development
Barbara A. Fiacco, James M. Flaherty, Paul T. Kim, Donald R. Ware; Foley Hoag LLP;
Legal Alert/Article February 13, 2012, previously published on February 9, 2012 Today, the U.S. Food and Drug Administration (FDA) released three draft guidance documents designed to assist industry in developing biosimilars. Biosimilar products are biological products shown to be highly similar (biosimilar) to biological products previously approved by FDA (known as...
| | FDA’s Draft Guidance on Scientific Considerations in Demonstrating Biosimilarity
Barbara A. Fiacco, James M. Flaherty, Paul T. Kim, Donald R. Ware; Foley Hoag LLP;
Legal Alert/Article February 13, 2012, previously published on February 10, 2012 Yesterday, the U.S. Food and Drug Administration released three draft guidance documents designed to assist industry in developing biosimilars and implementing the new abbreviated biologics approval pathway under section 351(k) of the Biologics Price Competition and Innovation Act of 2009 (BPCI...
| | U.S. Supreme Court to Decide Constitutionality of Affordable Care Act
Thomas Barker, Brian P. Carey, Tad Heuer; Foley Hoag LLP;
Legal Alert/Article November 16, 2011, previously published on November 15, 2011 Yesterday, the United States Supreme Court granted certiorari (meaning it has agreed to hear an appeal) on three petitions concerning the constitutionality of the Affordable Care Act (“ACA”). Given the Supreme Court’s timeline for the filing of briefs, oral argument will likely be...
| | SBIC Exemption from SEC Registration under Dodd-Frank Act
Bruce A. Kinn, Kevin K. Nolan, Robert G. Sawyer, Michael K. Wyatt; Foley Hoag LLP;
Legal Alert/Article July 21, 2011, previously published on July 18, 2011 The SEC’s final rules on the implementation of SEC registration requirements for investment advisers under the Investment Advisers Act of 1940, as recently modified by the Dodd-Frank Wall Street Reform and Consumer Protection Act (the “Dodd-Frank Act”), were published in the...
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