HRSA Extends Deadline for Compliance with 340B GPO Exclusion Guidance

May 2, 2013

On February 7, 2013, the Federal Health Resources and Services Administration (“HRSA”) issued a policy release concerning the 340B Drug Pricing Program (340B Program), which clarified its interpretation of the statutory prohibition against the procurement of covered outpatient drugs through a group purchasing organization (GPO) by certain covered entities. In a recent FAQ, HRSA has …

New FTC Clinical Integration Advisory Opinion — Norman PHO

February 26, 2013

The Federal Trade Commission on Wednesday, February 13, 2013, issued a new staff advisory opinion approving a clinical integration model for a physician-hospital organization in Oklahoma, called the Norman PHO. New York clients Click Here to read entire Legal Alert. New Jersey clients Click Here to read entire Legal Alert. Connecticut clients Click Here to …

Deadline to Report 2012 Breaches Approaches Quickly

Remember to electronically file reports of all HIPAA breaches (i.e., unauthorized disclosure of patient information involving unsecured protected health information) which occurred in 2012.  The report must be submitted to the U.S. Department of Health and Human Services, Office for Civil Rights by February 28, 2013.  The following link will take you to the report …

The Physician Payments Sunshine Act: Lots of Rules and Penalties. So Where is the Sunshine?

February 25, 2013

On February 8, 2013, the Centers for Medicare & Medicaid Services (“CMS”) published the Final Rule for the Physician Payments Sunshine Act (the “Sunshine Act”) which will impact physicians and teaching hospitals who receive anything of value from manufacturers of drugs, devices, biologicals, or medical supplies covered under Medicare, Medicaid or the Children’s health Insurance …

New York State Adopts Extensive Regulations Affecting Use of Restrictive/Intrusive Interventions With Developmentally Disabled Persons

January 22, 2013

Effective April 1, 2013, the New York State Office for People With Developmental Disabilities (“OPWDD”) adopted regulations that provide extensive requirements for interventions used in residential facilities and day programs licensed or operated by OPWDD to modify or control challenging behavior. Click  here to read the new regulations. The regulations set forth various new definitions, …