The Forecast is Gloomy for the Physician Payment Sunshine Act
September 17, 2012 John Lewis Hidden within the Patient Protection and Affordable Care Act (“Obamacare”) is a rather obscure provision, Section 6002, that, when implemented, will cause a tremendous...
View ArticleHere Comes the Sun: What You Need to Know about the Sunshine Act and Its...
March 18, 2013 Edward J. Buthusiem and Cheray Lynch Sieminski | Berkeley Research Group, LLC After years of deliberation, the Center for Medicare & Medicaid Services (CMS) published its...
View ArticleSunshine Act Final Rule is Finally Here: Prepare to Comply
March 27, 2013 Alyce Katayama | Quarles & Brady LLP On February 8, 2013, 16 months late, CMS published the final rule http://www.gpo.gov/fdsys/pkg/FR-2013-02-08/pdf/2013-02572.pdf implementing the...
View ArticleSunshine Act Final Rule is Finally Here: Prepare to Comply Part Two
April 3, 2013 Alyce Katayama | Quarles & Brady LLP This is Part Two in a two-part series, which discusses CMS’s final rule implementing the Sunshine Act. What Reports Are Required? AMs must...
View ArticleEnd of the Road in Sight for Myriad
May 14, 2013 Kevin E. Noonan, Ph.D. | McDonnell Boehnen Hulbert & Berghoff LLP The Supreme Court heard oral argument in the AMP v. Myriad Genetics case on April 15th, marking the penultimate step...
View ArticleManaging Compliance With Physician Payments Sunshine Act
December 4, 2013 Thomas W. Baker | Baker, Donelson, Bearman, Caldwell & Berkowitz, PC The pharmaceutical and medical device industries depend on relationships with physicians for both conducting...
View ArticleA New Era of Transparency for Competitors, Consumers and the Enforcement...
December 9, 2013 Julie K. Tibbets | Alston & Bird LLP By September 30, 2014, a publicly searchable database of pharmaceutical industry payments and transfers of value to physicians and teaching...
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The Next Generation of HCP Engagement and its Impact on Sunshine Compliance
December 12, 2013 Cegedim Relationship Management The Changing Needs of Today’s HCPs The changing healthcare environment, the pervasiveness of mobile devices and internet technologies, and the...
View ArticleThe Importance of Building HCP Relationships in Light of the Sunshine Act
December 23, 2013 Cegedim Relationship Management With the implementation of the Sunshine Act, pharmaceutical and medical device companies are going to be under increased scrutiny from HCP’s (health...
View ArticlePrioritization: A Key Theme at the CBI Compliance Congress
April 28, 2014 Ilyssa Levins | Center for Communication Compliance (CCC), Guarica Chacko | Edwards Lifesciences, Kevin Espinoza | Independent Consultant, Erik Ramanathan | Harvard Law School At the...
View ArticleAre Grey Areas In The Sunshine Act Leaving Manufacturers in A Fog?
May 14, 2014 Alice Dong, Esq., | Polaris While some areas of the U.S. Sunshine law are “clear as daylight”, after a glance, and then a nice, long, hard stare, other areas of the law may leave...
View ArticleSunlight on Continuing Medical Education and Research
May 16, 2014 Julie K. Tibbets | Alston & Bird LLP With implementation of the Sunshine Act underway and the first full calendar year of reporting almost half over, we are beginning to see some of...
View ArticleThe Compliance and Innovation Balancing Act in Pharma and Biotech
June 16, 2014 Christine Cassetta & Anne M. O’Brien | Quarles & Brady LLP The myriad of challenges pharmaceutical and biotechnology companies face today include striking a balance between...
View ArticleSeeing the Sunshine in the Sunshine Act
June 27, 2014 Ilyssa Levins | Center for Communication Compliance (CCC) I just returned from the DIA 2014 50th Annual Meeting in San Diego where three sessions examined the tremendous impact of the...
View ArticleSolar Power: KOL Relationships in the Era of the Sunshine Act
November 10, 2014 Paul Meade, M.Sc., MPH | Thought Leader Select With the advent of disclosures related to the Physician Payments Sunshine Provision of the Affordable Care Act, manufacturers are...
View ArticleCMS Returns Rejected Sunshine Data; What’s Next?
December 12, 2014 Hanna Socaciu | Compliance Implementation Services On September 30, 2014, CMS publically published Open Payments data and needless to say, it has been a bumpy road. With about 40...
View ArticlePharma’s Regulation Shifts in the Past Decade
April 17, 2015 Jennifer Shimek | KPMG & Bret Bissey | MediTract Changes in marketing, big recoveries reshape drug industry Regulation aims to serve as a brake to curb some of the market’s excesses,...
View ArticleOpen to Misinterpretation: Sunshine Act Disclosures Can Cloud Context of...
May 27, 2015 Jennifer Shimek | KPMG & Bret Bissey | MediTract A new wave of Open Payments (Sunshine) Act data will be available June 30, featuring updated 2013 and a first look at 2014 data about...
View ArticleKey Compliance Issues to Keep an Eye On in 2015: Off-Label Marketing and...
June 15, 2015 Michael Bauscher | Carter Ledyard & Milburn LLP As we near the midpoint of 2015, pharmaceutical and medical device manufacturers should take some time to review their compliance...
View ArticleTechnologies for Gathering and Processing Transfers of Value when Reporting...
March 9, 2016 Ross Dworkin | Blue Grotto Technologies To satisfy Open Payment mandates a great deal of information must be collected, verified, validated and organized. At events, meeting managers must...
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