Today is November 21, 2016. Sixty days from today? Friday, January 20, 2017. Otherwise known as the first day of the new Trump administration. What does this mean for the rules and regulations currently under review with the Office of Management and Budget (OMB)?
Republican Congressional leadership has issued a letter to the Obama administration, requesting that no additional regulations be released between now and inauguration day. This is a standard request made between the transition of two administrations, as regulations generally take effect 60 days after their release. Because we are now within a 60-day window of the Trump administration, it is not unreasonable to request a hold on regulatory activity until the new administration has an opportunity to review regulations that would go into effect under their watch.
However, there is no rule that says that the Obama administration can’t release any more regulations. Here is a brief snapshot of some of the current health-care regulations pending at OMB that we have been keeping an eye on:
- 340B Program Omnibus Guidelines. This notorious omnibus guidance has spent a lot of time with OMB over the past several years, in one form or another. After several rounds of revisions, a proposed guidance was released in August 2015, and included a number of program changes, including changes in the definition of a 340b-eligible patient, contract pharmacy requirements, and the treatment of off-site outpatient facilities linked with a “parent” 340b covered entity. The final guidance has been at OMB since September 1, 2016.
- Medicaid Supplemental Payment and Accountability Proposed Rule. This rule arrived at OMB in July, and would establish new reporting requirements for states on supplemental payments for Medicaid providers, including disproportionate share payments (DSH).
- Changes to Medicare Claims and Entitlement, Medicare Advantage Organization Determination, and Medicare Part D Determination Appeals Procedures Proposed Rule. Hot off the presses (this rule arrived at OMB November 18, 2016), this includes proposed revisions to the treatment of appeals and coverage determination at the Administrative Law Judge (ALJ) level.
- Pre-Existing Condition Insurance Plan Program Updates Interim Final Rule. If they give out awards for rules with the longest OMB tenure, this one would be in the running. It has been under review since February 2015 and would implement “several interim final provisions published in 2010 implementing he requirements for group and individual health plans under the Affordable Care Act.” With the ACA’s future in doubt, this one may never see the light of day.
Of course, as any rule or regulations are released, you can find out information here at www.apinsight.org.