Topic
340B
257 published works
Health Industry Washington Watch
HRSA Pushes Back 340B Rule Implementation Until October 1, 2017
Changes to the rules governing calculation of the ceiling price and application of civil monetary penalties under the 340B drug pricing program will not be implemented until October 1, 2017…
Capital Thinking
FDA User Fee Reauthorization Moves to Full Committee; HHS Further Delays Bundled Payment Models and Changes to 340B Drug Discount Program
Legislative Activity FDA User Fee Reauthorization Moves to Full Committee While passing health reform through Congress has been a struggle, the Food and Drug Administration (FDA) user fee legislation has…
Capital Thinking
The AHCA: On to Rules Committee and House Floor; The Third Prong: Additional Legislation; HRSA Further Delays 340B Final Rule
Legislative Activity The AHCA: On to Rules Committee and House Floor The American Health Care Act (AHCA) continues to make its way through the legislative process. After surviving markups in…
Health Industry Washington Watch
340B Ceiling Price/CMP Rule Effective Date Pushed Back to May 22, 2017 — “At the Earliest”
The Health Resources and Services Administration (HRSA) is delaying the effective date of its January 5, 2017 final rule on the calculation of the ceiling price and application of civil monetary…
Capital Thinking
Potential for Reconciliation Language to Move Through Committees This Week; HRSA Issues Notice to Delay Implementation of Final Rule on 340B
Legislative Activity Potential for Reconciliation Language to Move Through Committees This Week With reports that reconciliation language was available for House Republicans to review last week, sources indicate that the…
Healthcare Law Blog
The 340B Program Omnibus Guidance: Not Ready for Prime Time
By Jordan Grushkin, Kenneth Yood
On January 30, 2017, the proposed 340B Drug Pricing Program (the “340B Program”) Omnibus Guidance (the “Guidance”) first issued by the Health Resources and Services Administration (HRSA) in August of…
To Be or Not to 340B Blog
The Omnibus Guidance is Dead!
By Alyce Katayama, Elizabeth Gebarski
The proposed 340B Drug Pricing Program Omnibus Guidance that was issued in August 2015 and promised to turn the 340B world on its head was withdrawn on January 30, 2017.…
Health Industry Washington Watch
HRSA Publishes Final Rule on 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties
The Health Resources and Services Administration (HRSA) has published a final rule to implement civil money penalty (CMP) provisions added to section 340B of the Public Health Service Act under…
Consumer Finance Monitor
CFPB receives unprecedented level of comments on payday, title and high-cost installment loan proposal
The comment period for the CFPB’s proposed rule on Payday, Title and High-Cost Installment Loans ended Friday, October 7, 2016. The CFPB has its work cut out for it in…
Consumer Finance Monitor
Ballard Spahr partner Dee Spagnuolo joins CFPB OMWI Director on panel at ABA meeting
By Brian D. Pedrow, Suzanne O. Lufadeju
Members of Ballard Spahr's Consumer Financial Services group recently participated in the American Bar Association Business Law Section Annual Meeting held in Boston, Massachusetts. On September 8, Ballard partner, Dee Spagnuolo,…