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Patient Protection and Affordable Care Act (PPACA) › New Guidance › Food and Drug Administration (FDA)

The Patient Protection and Affordable Care Act (PPAC), also known as Obamacare, is a United States federal statute passed in March of 2010. The Act creates a nationwide insurance system and provides federal... more +
The Patient Protection and Affordable Care Act (PPAC), also known as Obamacare, is a United States federal statute passed in March of 2010. The Act creates a nationwide insurance system and provides federal subsidies to reduce the number of uninsured citizens. less -
Ogletree, Deakins, Nash, Smoak & Stewart,...

ACA-Required Coverage of Contraceptive Care Remains Agency Focus

Ogletree, Deakins, Nash, Smoak & Stewart,... on

Once again, the U.S. Departments of Labor, Health and Human Services, and the Treasury have issued guidance on the Affordable Care Act’s (ACA) required coverage of contraception without cost sharing, clarifying the permitted...more

McDonnell Boehnen Hulbert & Berghoff LLP

FDA Releases Naming Guidance

McDonnell Boehnen Hulbert & Berghoff LLP on

The Biologic Price Control and Innovation Act (BPCIA), enacted as part of President Obama's Affordable Care Act (better known as "Obamacare," Public Law 111-148), provided for the first time in the U.S. a path for FDA...more

Franczek P.C.

Departments Issue Additional Guidance on Preventive Services

Franczek P.C. on

The Departments of Labor (DOL), Health and Human Services (HHS), and Treasury (collectively, the Departments) issued guidance in the form of FAQs on the ACA’s preventive services mandate. The ACA requires non-grandfathered...more

King & Spalding

CMS Issues Guidance on Reimbursement for Biosimilars under Medicare and Medicaid

King & Spalding on

Biosimilars Are Generally Treated as Single Source Drugs - On March 30, 2015, in the wake of the first biosimilar product licensed by the Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services...more

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