All posts by Kathleen Peterson

FDA Revises Draft Reprint Guidance: Includes New Recommendations for Clinical Practice Guidelines

In today’s Federal Register, the U.S. Food and Drug Administration (“FDA”) announced the availability of a revised draft guidance document titled: “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices” (the “Revised Draft Reprint Guidance”).  This revises the FDA’s 2009 draft guidance document on the subject, which was […]

CMS Proposes Rate Adjustments and Policy Changes for Medicare Advantage and Medicare Part D Programs: Draft Rate Notice and “Call Letter” for 2015 Plan Year Released

On February 21, 2014, the Centers for Medicare & Medicaid Services (“CMS”) released its Advance Notice of Methodological Changes for Calendar Year 2015 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies (the “Draft Rate Notice”), as well as its draft “Call letter” for the 2015 […]

Important Dates for Coding and Reimbursement Announced: CMS Schedules Public HCPCS Meetings for Drugs, Biologics, DME and Various Other Products

In today’s Federal Register, the Centers for Medicare & Medicaid Services (“CMS”) announced the dates, time and location of the Healthcare Common Procedure Coding System (“HCPCS”) public meetings for calendar year 2014.  CMS hosts these meetings to discuss the preliminary coding and payment determinations for all new public requests for […]

HHS Office of Inspector General Releases 2014 Work Plan: New Items Relevant to Prescription Drugs

On February 6, 2014, the U.S. Department of Health & Human Services (“HHS”) Office of Inspector General (“OIG”) released its annual 2014 Work Plan.  In addition, the OIG has posted a 25-minute video vignette featuring senior OIG executives discussing the OIG’s top priorities for fiscal year 2014.  The OIG annually […]

CMS Proposes Medicare Part D Rule for 2015 Contract Year – Antidepressants and Immunosuppressants Would No Longer Be “Protected Classes”; Antipsychotics May Follow

On January 6, 2014, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule: “Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs” (the “Proposed Rule”).  The Proposed Rule is expected to be published in the Federal Register on […]

CMS Posts Final National Average Drug Acquisition Cost Files – Possible Pharmacy Reimbursement Adjustments to Follow

As you head out for the holiday, you may want to stop by the Centers for Medicare & Medicaid Services (“CMS”) website to check out CMS’s latest gift – the posting of the final National Average Drug Acquisition Cost (“NADAC”) Files.  Along with the final NADAC files posted today (November […]

Update on HHS “Qualified Health Plans” Determination: Grassley Weighs in…

As we reported earlier this week, the U.S. Department of Health & Human Services (“HHS”) recently issued a letter concluding that HHS “does not consider [Qualified Health Plans (QHPs)], other programs related to the Federally-facilitated Marketplace, and other programs under Title I of the Affordable Care Act to be federal […]