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340B Update: HRSA Accelerates Implementation of Long-Delayed 340B Pricing and Manufacturer Penalties Rule
  • K&L Gates
  • USA
  • November 2 2018

On October 31, 2018, the U.S. Department of Health and Human Services (“HHS”) and the Health Resources and Services Administration (“HRSA”) released

TCPA Healthcare Companies Seek Ruling on Joint Petition Filed in 2016
  • Klein Moynihan Turco LLP
  • USA
  • August 31 2018

Last week, a group of healthcare companies sent a letter to the Federal Communications Commission (“FCC”) seeking clarification regarding how

340B Update: CMS Proposes Changes to OPPS Reimbursement for Nonexcepted PBDs
  • K&L Gates
  • USA
  • July 30 2018

As part of the Calendar Year (“CY”) 2019 Medicare Outpatient Prospective Payment System (“OPPS”) Proposed Rule, the Centers for Medicare and Medicaid

HIPAA Small Breach Notifications Due March 1
  • Davis Wright Tremaine LLP
  • USA
  • February 12 2018

March 1, 2018 is the date by which HIPAA covered entities must notify the U.S. Department of Health and Human Services Office for Civil Rights (OCR)

Rite Aid Wins Summary Judgment in TCPA Action Involving Prerecorded, Automated Call for Flu Shot Reminder
  • Womble Bond Dickinson (US) LLP
  • USA
  • April 27 2017

In an outright win for pharmacies, the U.S. District Court for the Southern District of New York, in the attached opinion, granted Rite Aid’s motion

Maryland board of pharmacy stages a limited retreat from its definition of “manufacturer” for licensing purposes
  • Porzio Bromberg & Newman PC
  • USA
  • July 7 2011

Any manufacturer or private label distributor that utilizes a contract manufacturing organization (CMO) can share horror stories about the year-end renewal of the Maryland distribution license.

HHS proposes changes to the HIPAA privacy rule’s requirement for accounting of disclosures and the addition of a new individual right to an access report
  • Latham & Watkins LLP
  • USA
  • June 20 2011

On May 27, 2011, the US Department of Health and Human Services (HHS) announced proposed changes to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule.

CMS proposes ACA Medicare claims data sharing rule
  • Reed Smith LLP
  • USA
  • June 14 2011

On June 8, 2011, CMS published a proposed rule that would implement an ACA requirement to make standardized extracts of Medicare Parts A, B, and D claims data available to "qualified entities."

HHS issues proposed rule modifying accounting of disclosures under HIPAA and HITECH
  • Ropes & Gray LLP
  • USA
  • June 13 2011

Under the HIPAA Privacy Rule, individuals are currently entitled to receive an accounting of disclosures made by a covered entity of their Protected Health Information (“PHI”).

HHS issues notice of proposed rulemaking for accounting of disclosures of protected health information
  • Hunton Andrews Kurth LLP
  • USA
  • May 31 2011

On May 27, 2011, the Department of Health and Human Services ("HHS") issued a notice of proposed rulemaking regarding the HIPAA Privacy Rule provision that requires covered entities to provide an accounting of disclosures of protected health information ("PHI") to individuals upon request.