Regulation - CMS Contemplating Telemedicine Changes - The Centers for Medicare & Medicaid Services (CMS) recently published what it described as a "major proposed rule" that covers a number of topics that could have...more
Earlier this month the House Energy and Commerce Committee’s subcommittee on Government Oversight and Investigations held its second hearing on the 340B Drug Discount Program. The hearing followed on the heels of a July 18th...more
The Health Resources and Services Administration (HRSA) recently issued proposed omnibus guidance (Omnibus Guidance) interpreting various provisions of the 340B Drug Pricing Program (340B Program). The 340B Program allows...more
As noted in our previous client alert, the Health Resources and Services Administration (“HRSA”) released its highly anticipated proposed 340B Drug Pricing Program Omnibus Guidance (“Guidance”). The Guidance offers updated...more
On Friday, August 28, 2015, the Health Resources and Services Administration (“HRSA” or “the Agency”) published in the Federal Register Notice of its proposed “omnibus” or “mega” guidance (“Proposed Guidance”) regarding...more
On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published proposed Omnibus Guidance (the “Proposed Guidance”) governing policies related to section 340B of the Public Health Service Act (“PHSA”),...more
Last week, the Health Resources and Services Administration (HRSA), part of HHS, released proposed new guidance for covered entities enrolled in the 340B Drug Pricing Program, as well as drug manufacturers required to make...more
In August 27, 2015, the U.S. Department of Health and Human Services (HHS) released the long-awaited and much-anticipated proposed 340B Drug Pricing Program (340B Program) Omnibus Guidance (Proposed Guidance). The Proposed...more
CMS recently released data collected through the Open Payments Program in accordance with the Affordable Care Act from applicable manufacturers and group purchasing organizations (GPOs) about payments and other transfers that...more
The GAO had drawn a bead on GPOs. In a report issued yesterday the Government Accountability Office expressed concern over the effect of GPOs (group purchasing organizations) on Medicare rates. The report recommended that...more
With the June 30 deadline for Phase 2 Sunshine Act reports by pharmaceutical and medical device manufacturers (“Applicable Manufacturers”) and group purchasing organizations (“GPOs’) quickly approaching, the Centers for...more
Three weeks after the commencement of data collection under the Physician Payment Sunshine Act (the “Act”), the Centers for Medicare & Medicaid Services (“CMS”) continues to issue guidance to assist applicable manufacturers...more
On February 8, 2013, 16 months after the statutory deadline, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register the final regulation implementing the physician payment transparency...more
On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited final regulations implementing the Physician Payment Sunshine Act (Act or Sunshine Act). The Sunshine Act requires drug,...more
Reports on Physician Ownership and Investment Interests The Sunshine Act requires applicable manufacturers, as well as applicable GPOs, to report to the Secretary, in electronic form, certain information concerning...more
Report Submission and Review Pre-Submission Review is Not Required Applicable manufacturers may voluntarily provide covered recipients the opportunity to review the data prior to submission to CMS, but doing so is not...more
Public disclosure of payments from pharmaceutical, medical device, biologic, and medical supply manufacturers to physicians and hospitals will begin under a final rule on the Physician Payments Sunshine Act (Sunshine Act)...more
On Friday, February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) released the highly anticipated final rule to implement the federal Physician Payments Sunshine Act (the “Sunshine Act”). The final rule will...more
This afternoon, the Centers for Medicare & Medicaid Services (CMS) released the long-awaited final rule (Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act). The Sunshine Act requires manufacturers of...more