Cooley Client Alert: HHS OIG Issues Supplemental Special Advisory Bulletin on Patient Assistance Programs

The following Cooley Client Alert was released today.  The PDF version is available here.    On May 21, 2014, the United States Department of Health & Human Services Office of Inspector General (“HHS OIG”) issued a fifteen page Supplemental Special Advisory Bulletin: Independent Charity Patient Assistance Programs (“Supplemental Bulletin”) to […]

CMS Announces that Sunshine Phase 2 Reporting Will Begin June 1st; Assumptions Document and Attestation Information Also Released

The Centers for Medicare & Medicaid Services (CMS) announced today that Phase 2 of the Open Payments reporting will begin on Sunday, June 1st and continue through Monday, June 30th.  Instructions from CMS for Phase 2 are available here; additional information regarding CMS data submission resources and Phase 2 tutorials are […]

OIG Issues Proposed Rule Related to Health Care Exclusion Authority

The Health and Human Services Office of Inspector General (OIG) issued a proposed rule related to its authority to exclude individuals and health care entities from participation in federal health care programs, such as Medicare and Medicaid.  The proposed rule codifies changes made by the Affordable Care Act of 2010 (ACA), which […]

Two New York Providers Reach Largest HIPAA Settlement with OCR To Date

Earlier this week, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) reached settlements with New York and Presbyterian Hospital (“NYP”) and Columbia University (“CU”) for alleged violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).  The entities operate a shared data network […]

CMS Releases the First Sunshine Reporting Phase 2 Tutorial for Manufacturers and GPOs

As discussed in a blog post last week, the Centers for Medicare & Medicaid Services (CMS) released today the first of three tutorials for pharmaceutical, medical device and biotechnology manufacturers and group purchasing organizations (GPOs) related to Phase 2 reporting of payments and other transfers of value provided to physicians and […]

CMS RELEASES OPEN PAYMENTS REGISTRATION INFORMATION FOR PHYSICIANS AND TEACHING HOSPITALS; PHASE 2 TIMELINE FOR MANUFACTURERS AND GPOS

The Centers for Medicare & Medicaid Services (CMS) released today information regarding registration in the Open Payments system for physicians and teaching hospitals interested in reviewing and verifying data reported by pharmaceutical, biotechnology and medical device manufacturers and group purchasing organizations (GPOs) in connection with the Physician Payments Sunshine Law prior […]

New HIPAA Settlements Show OCR’s Focus on Encryption

Last week, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) reached settlements with two separate entities for alleged violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).  Specifically, Concentra Health Services (“Concentra”) agreed to pay $1,725,220 following the theft of an unencrypted laptop and the […]