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Pharmaceuticals, Medical Devices, Health Care & Life Sciences - ..Drugs - Approval of Innovative Drugs and Key Sector Generic Drugs to be Expedited (Shanghai Securities Journal 2013-04-23): Given the...more
Patton Boggs recently advised Satori Capital, a Dallas-based private equity firm, on its acquisition of Longhorn Health Solutions, Inc. Longhorn is headquartered in Austin, Texas and is a leading direct-to-home provider of...more
I am seeing a lot of interest from health care clients regarding the Foreign Corrupt Practices Act (FCPA). I usually stay away from this topic because so many others cover it in detail. However, I want to point out that in...more
I am often called upon to address the nature of how regulatory controls may apply to the organization of healthcare companies in their ability to create, deliver, and capture value (their ‘business models’). While no...more
Originally Published in BNA Bloomberg, Medical Devices Law & Industry Report on March 20, 2013. On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited final regulations for...more
After years of deliberation, the Center for Medicare & Medicaid Services (CMS) published its long-awaited regulations to implement the specific requirements of the Physician Payment Sunshine Act (Sunshine) on February 1,...more
On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-delayed final rule that is intended to implement the Physician Payments Sunshine provisions that were included in the Patient...more
People like to think they have it the hardest in life. I call it the competition among victims. If you are in the healthcare industry and fall under the Physician Payments regulations, then I think you are on your way to...more
The Centers for Medicare and Medicaid Services (CMS) issued the final regulations on the U.S. Sunshine Act on February 8, 2013. Transparency Reports and Reporting of Physician Ownership or Investment Interests, 78 Fed. Reg....more
In This Issue: - Interpretation and Clarification of Key Definitions ..Applicable Manufacturers ..Applicable GPOs ..Covered Drug, Device, Biological or Medical Supply ..Covered Recipients ...more
On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) of the Department of Health and Human Services (HHS) released the long-awaited Final Rule (Rule) to implement the “Sunshine” provisions of the Affordable...more
On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) published long-awaited rules (the "Rules") detailing manufacturers' and group purchasing organizations' reporting requirements under Section 6002 of the...more
Pharmaceuticals, Medical Devices, Health Care & Life Sciences - News & Regulations: ..Industry Calls for Reform of Lagging Drug Review System (Global Times 2012-12-02) – December 3, 2012...more
On December 17, 2012, the Ministry of Health (“MOH”) issued the Tentative Guidelines for Centralized Procurement of High Value Medical Consumables (the “Guidelines”) with immediate effect, with an aim to control health care...more
A recent California Court of Appeal decision out of the Second District has provided further clarity to the scope of California products liability law by reasserting the general rule that precludes strict liability for design...more
Recent weeks have seen two significant developments with respect to federal and state laws regulating financial interactions between pharmaceutical and medical device companies and health care providers: (1) the Centers for...more
Last week, Congress adopted comprehensive health care reform through the passage of the Patient Protection and Affordable Health Care Act (H.R. 3590) (signed into law on March 23) and the Health Care and Education...more
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