January 25, 2017—The Trump administration has asked federal departments and agencies to freeze pending regulations and guidance documents – presumably including the 340B mega-guidance – for review by an administration appointee or designee. Incoming administrations commonly embargo the preceding presidency’s newest and planned rules. [ms-protect-content id=”2799″]
HRSA sent the final mega-guidance to the White House Office of Management and Budget on Sept. 1, when President Obama was still in office, for clearance to be published in the Federal Register. The mega-guidance was still at OMB when the presidential transition occurred.
White House Chief of Staff Reince Priebus’s Jan. 20 regulatory freeze memo to federal agencies also presumably covers the final regulation HRSA is writing to establish a mandatory and binding administrative dispute resolution process for the 340B program. HRSA published the proposed rule in August with comments due in October.
It is not clear how Priebus’s memo will affect HRSA’s new final rule implementing fines for drug manufacturers that knowingly and intentionally overcharge safety-net healthcare providers. The rule also sets standards for calculating 340B ceiling prices. HRSA published the final rule on Jan. 5 and it was due to take effect on March 6. HRSA planned to begin enforcing it on April 1, the first day of the second calendar quarter. Priebus asked departments and agencies to postpone for 60 days the effective date of regulations that have been published but have not yet taken effect. The rules will be evaluated and could be delayed even further or reopened for public comment.
Register – 340B Coalition Winter Conference – February 1-3, 2017 – San Francisco, Calif. [/ms-protect-content]