Publications

Searched Practice: Health Care

"Sunshine Act Data Collection to Begin August 1," Covington E-Alert (7/30/2013)
Stefanie Doebler Co-Author, Anna Kraus Co-Author, Scott Danzis Co-Author, Ellen Flannery Co-Author

"HRSA Issues Final 340B Orphan Drug Exclusion Rule Imposing New Obligations on Covered Entities and Creating New Risks for Manufacturers," Covington E-Alert (7/26/2013)
Jennifer Plitsch Co-Author, Christopher Pruitt Co-Author, Stephanie Barclay Co-Author

"What Drug Manufacturers Need to Know About 340B in 2013," Covington E-Alert (2/21/2013)
Jennifer Plitsch Co-Author, Christopher Pruitt Co-Author, Stephanie Barclay Co-Author

"CMS Issues Final Rule to Implement the Sunshine Act," Covington E-Alert (2/13/2013)
Anna Kraus Co-Author, Stefanie Doebler Co-Author, Meghan Monaghan Co-Author

"HHS Issues Long-Awaited Final HITECH Omnibus Rule," Covington Advisory (2/7/2013)
Anna Kraus Co-Author, Rachel Grunberger Co-Author, Shelton Abramson Co-Author, Dena Feldman Co-Author

"Comparative Claims: Learning from FDA Warning and Untitled Letters," Regulatory Focus (November 2012)
Stefanie Doebler Author

"China's New Blacklist: The Impact for Drug and Device Lawbreakers," Scrip Regulatory Affairs (September 2012)
Shaoyu Chen Co-Author, Scott Cunningham Co-Author, Jason Ma Co-Author, Eric Carlson Co-Author

"PPACA's Impact: The Election, 2013 and Beyond," Law360 (7/20/2012)
Joan Kutcher Co-Author, Amy Moore Co-Author, Kendra Roberson Co-Author

"Supreme Court Rules on the Constitutionality of the Affordable Care Act," Covington Advisory (7/2/2012)
Roderick De Arment Co-Author, Holly Fechner Co-Author, Joan Kutcher Co-Author

"Supreme Court Rules on the Constitutionality of the Affordable Care Act," Covington Advisory (6/29/2012)
Caroline Brown Co-Author, Anna Kraus Co-Author, Matthew Berns Co-Author, Dena Feldman Co-Author, Rachel Grunberger Co-Author, Philip Peisch Co-Author

"Supreme Court Upholds Affordable Care Act: Implications for Employers," Covington E-Alert (6/29/2012)
Roderick De Arment Co-Author, Holly Fechner Co-Author, Joan Kutcher Co-Author

"Preparing for Supreme Court ACA Decision: Analysis of Potential Outcomes and Impacts," Covington Advisory (6/15/2012)
Anna Kraus Co-Author

"CMS Delays Physician Payments Sunshine Act Data Collection Requirement," Covington E-Alert (5/7/2012)
Stefanie Doebler Co-Author, Anna Kraus Co-Author

"From Research to Revenue: Coverage and Reimbursement for Life Sciences Products – When Parallel Review Is Right for You," Bloomberg Law Reports (2/23/2012)
Anna Kraus Co-Author, Katherine Phillips Co-Author

"France - A "Sunshine Act" for the Healthcare Industry," Covington E-Alert (1/20/2012)

"CMS Issues Proposed Rule Implementing Sunshine Act Reports Regarding Ownership or Investment Interests Held by Physicians," Covington E-Alert (1/3/2012)
Anna Kraus Co-Author, Stefanie Doebler Co-Author

"CMS Issues Proposed Rule Implementing Sunshine Act: Review, Correction, and Publication of Data on Public Website," Covington E-Alert (12/30/2011)
Anna Kraus Co-Author, Stefanie Doebler Co-Author

"CMS Issues Proposed Rule Implementing Sunshine Act," Covington E-Alert (12/23/2011)
Stefanie Doebler Co-Author, Anna Kraus Co-Author

"Proposed Regulations on Branded Prescription Drug Fee for Sales to Government Payors," Bloomberg Law Reports (11/29/2011)
Katherine Phillips Co-Author

"IRS Issues Regulations on Calculation of Branded Prescription Drug Fee," Covington E-Alert (9/1/2011)
Anna Kraus Co-Author, Katherine Phillips Co-Author

"Coverage and Reimbursement Considerations for In Vitro Diagnostics," Bloomberg Health Law Report (June 2011)
Anna Kraus Co-Author, Katherine Phillips Co-Author

"Accountable Care Organization Basics," Covington E-Alert (4/15/2011)
Kevin Shortill Co-Author, Katherine Phillips Co-Author

"Health Care Reform: Federal Court Strikes Down Individual Coverage Mandate; Rest of Law Unaffected," Covington E-Alert (12/13/2010)
Rachel Grunberger Co-Author

"IRS Issues Guidance on Calculation of Branded Prescription Drug Fee," Covington E-Alert (December 2010)

"CMS Releases Final Discount Program Model Agreements," Covington E-Alert (8/3/2010)
Anna Kraus Co-Author, Rachel Grunberger Co-Author

"HHS Issues Proposed Rule to Implement HITECH Changes to HIPAA," Covington E-Alert (7/26/2010)
Anna Kraus Co-Author, Rachel Grunberger Co-Author

"Update on the Medicare Coverage Gap Discount Program," Covington E-Alert (6/3/2010)
Anna Kraus Co-Author, Rachel Grunberger Co-Author

"Guide to Applying for Therapeutic Discovery Project Grants and Tax Credits," Covington E-Alert (June 2010)
Ellen Corenswet Co-Author, Roderick De Arment Co-Author, Anna Kraus Co-Author

"CMS Issues Draft Guidance on Medicare Part D Discount Program," Covington E-Alert (5/3/2010)
Anna Kraus Co-Author, Rachel Grunberger Co-Author

"Health Care Reform: Annual Fee On Prescription Drug Manufacturers And Excise Tax On Medical Device Manufacturers," Covington E-Alert (4/29/2010)
Anna Kraus Co-Author

"Health Care Reform: Biosimilars Licensing and Reimbursement," Covington E-Alert (4/12/2010)
Jeffrey Elikan Co-Author, Melissa Whittingham Co-Author

"Health Care Reform: Medicare Part D Donut Hole and Protected Classes," Covington E-Alert (April 2010)
Anna Kraus Co-Author, Rachel Grunberger Co-Author

"Health Care Reform: Therapeutic Discovery Project Tax Credits and Grants for Small Employers," Covington E-Alert (April 2010)
Anna Kraus Co-Author, Noellyn Davies Co-Author

"Health Care Reform: Sunshine Provisions," Covington E-Alert (April 2010)
Anna Kraus Co-Author

"Health Care Reform: 340B Drug Pricing Program," Covington E-Alert (April 2010)
Anna Kraus Co-Author, Jennifer Plitsch Co-Author

"Health Care Reform: Medicaid Prescription Drug Reimbursement," Covington E-Alert (April 2010)
Stefanie Doebler Co-Author, Anna Kraus Co-Author

"Maine Adopts Final Clinical Trial Reporting Regulations," Covington E-Alert (11/9/2009)

"HHS Issues Rule Implementing Increased Penalties for HIPAA Violations," Covington E-Alert (11/6/2009)
Anna Kraus Co-Author, Rachel Grunberger Co-Author

"HHS, FTC Issue Breach Notification Rules for Electronic Health Information," Covington E-Alert (9/1/2009)
Anna Kraus Co-Author, Rachel Grunberger Co-Author

"HHS Issues Guidance and Request for Information on Technologies and Methodologies to Secure Protected Health Information for the Purposes of Breach Notification Provisions," Covington E-Alert (4/29/2009)
Anna Kraus Co-Author, Noellyn Davies Co-Author

"FTC Seeking Comment on Proposed Breach Notification Rule for Electronic Health Information," Covington E-Alert (4/29/2009)
Scott Danzis Co-Author, Anna Kraus Co-Author, Noellyn Davies Co-Author

"Federal Spending Bill Creates New Categories of Nominal Price Exclusions," Covington E-Alert (3/20/2009)
Scott Danzis Co-Author, Anna Kraus Co-Author, Stefanie Doebler Co-Author

"Health Information Technology Provisions in the Economic Stimulus Bill," Covington E-Alert (2/23/2009)

"Health Information Technology Provisions in Economic Stimulus Bill Expand Privacy and Security Requirements for Health Information," Covington E-Alert (2/23/2009)
Yaron Dori Co-Author, Anna Kraus Co-Author

"REACH and Its Impact on Medical Devices," Covington E-Alert (September 2008)
Cándido García Molyneux Co-Author

"Summary of DDMAC Enforcement Correspondence - August 2007," Covington E-Alert (9/5/2007)
Peter Safir Co-Author, Michael Labson Co-Author, Stefanie Doebler Co-Author

"CMS Issues Final Rule to Implement Medicaid Drug Pricing and Reimbursement Provisions of the Deficit Reduction Act," Covington E-Alert (8/7/2007)
Anna Kraus Co-Author, Stefanie Doebler Co-Author

"Summary of DDMAC Enforcement Correspondence - July 2007," Covington E-Alert (8/6/2007)
Michael Labson Co-Author, Peter Safir Co-Author, Stefanie Doebler Co-Author

"Learned Intermediary Doctrine: Required By Fed Law?," Health Law 360 (7/17/2007)
Michael Imbroscio Co-Author, Paul Schmidt Co-Author, Michael Labson Co-Author

"CMS Issues Proposal to Revise Clinical Trial Policy National Coverage Determination," Covington E-Alert (5/3/2007)
Anna Kraus Co-Author, Michael Labson Co-Author, Ellen Flannery Co-Author, Peter Safir Co-Author, Stefanie Doebler Co-Author

"CMS Issues Proposed Rule to Implement Medicaid Drug Pricing and Reimbursement Provisions of the Deficit Reduction Act," Covington E-Alert (1/12/2007)
Anna Kraus Co-Author, Stefanie Doebler Co-Author

"Policyholder Alert," Covington E-Alert (1/11/2007)
Marialuisa Gallozzi Co-Author, Scott Levitt Co-Author

"REACH and Its Impact on Medical Devices," Covington E-Alert (January 2007)
Peter Bogaert Co-Author, Grant Castle Co-Author, Cándido García Molyneux Co-Author

"REACH and Its Impact on Pharmaceuticals," Covington E-Alert (January 2007)
Peter Bogaert Co-Author, Grant Castle Co-Author, Cándido García Molyneux Co-Author

"REACH and Its Impact on Cosmetics," Covington E-Alert (January 2007)
Peter Bogaert Co-Author, Cándido García Molyneux Co-Author, Henriette Tielemans Co-Author

"California Will Negotiate Drug Prices with Manufacturers in New Discount Drug Program," Covington E-Alert (10/9/2006)
Anna Kraus Co-Author, James Snipes Co-Author, Ethan Posner Co-Author, Michael Labson Co-Author

"Employee Education on False Claims Recovery," Covington E-Alert (10/4/2006)
Ethan Posner Co-Author, Anna Kraus Co-Author

"New HHS Regulations Protect Arrangements Involving Health Information Technology," Covington E-Alert (8/24/2006)
Anna Kraus Co-Author, Michael Labson Co-Author

"CMS Issues Proposed Rule for the Competitive Acquisition Program," Covington E-Alert (4/5/2005)
Anna Kraus Co-Author, Ellen Flannery Co-Author

"Medicare Prescription Drug Benefit: CMS Clarifies Final Rules for Medicare Prescription Drug Benefit Program," Covington E-Alert (4/4/2005)
Anna Kraus Co-Author, Ellen Flannery Co-Author

"Analysis of Final Rule Implementing Medicare Part D Prescription Drug Benefit," Covington E-Alert (2/1/2005)
Anna Kraus Co-Author, Ellen Flannery Co-Author

"Overview of Final Rule Implementing Medicare Part D Prescription Drug Benefit," Covington E-Alert (1/27/2005)
Anna Kraus Co-Author, Ellen Flannery Co-Author

"Medicare Part D: USP Final Model Guidelines," Covington E-Alert (January 2005)
Anna Kraus Co-Author, Ellen Flannery Co-Author

"CMS Establishes PDP and MA Regions," Covington E-Alert (December 2004)
Anna Kraus Co-Author, Michael Labson Co-Author

"CMS Issues Guidelines for the Review of Part D Formularies and Procedures; Additional Bidding Information Also Provided," Covington E-Alert (December 2004)
Anna Kraus Co-Author

"Comments Submitted in Response to CMS Medicare Drug Benefit Proposed Rule," Covington E-Alert (December 2004)
Anna Kraus Co-Author

"CMS Issues Ten-Year Record Retention Rule for Medicaid Drug Rebate Program," Covington E-Alert (December 2004)
Anna Kraus Co-Author, Scott Danzis Co-Author

"Sponsoring a Medicare Part D Prescription Drug Plan," Covington E-Alert (October 2004)
Anna Kraus Co-Author

"Manufacturer Submission of Average Sales Price Data for Medicare Part B Drugs and Biologicals: CMS Final Rule on ASP Calculation Methodology," Covington E-Alert (9/17/2004)
Anna Kraus Co-Author, Ellen Flannery Co-Author, Michael Labson Co-Author, Ethan Posner Co-Author

"Key Provisions of the CMS Medicare Drug Benefit Proposed Rule," Covington E-Alert (August 2004)
Anna Kraus Co-Author, Ellen Flannery Co-Author, Peter Safir Co-Author, Ethan Posner Co-Author

"Manufacturer Submission of Average Sales Price Data for Medicare Part B Drugs and Biologicals: CMS Interim Final Rule," Covington E-Alert (4/14/2004)
Anna Kraus Co-Author, Ellen Flannery Co-Author, Peter Safir Co-Author, Ethan Posner Co-Author

"Average Wholesale Price Reform Provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003," Covington E-Alert (12/11/2003)
Anna Kraus Co-Author, Ellen Flannery Co-Author, Peter Safir Co-Author, Michael Labson Co-Author

"Prescription Drug Benefit Provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003," Covington E-Alert (11/26/2003)
Anna Kraus Co-Author, Michael Labson Co-Author, Ellen Flannery Co-Author, Peter Safir Co-Author