In The Know
An Uncertain Landscape
Healthcare is an uncertain landscape at the moment. The incoming administration has promised a number of changes, including the potential repeal of the Affordable Care Act. As a result, politicians, citizens, and companies don’t seem to have a handle on what is changing and what is staying the same. At CiiTA, we are also feeling the pains of uncertainty. Health care reform has been promised, but nobody, including the President-Elect, has given us a clear picture of what that will be.
Although 31 states expanded their Medicaid programs under the ACA, all 50 states administer a Medicaid program of some kind or another. If changes take place outside of the expansion, or aid is reduced, states could face new burdens on their budgets and different regulatory requirements.
Even 340B-land has looming, uncertain change. At the beginning of January, the Health Resources Services Administration (HRSA) released its final rule regarding the calculation of the 340B ceiling price, and the imposition of civil monetary penalties on manufacturers that knowingly and intentionally overcharge 340B covered entities. However, incoming Presidents have historically ordered a 60-day delay in the effective date of any final rule that has not taken effect by inauguration day. The purpose of the 60-day delay is to allow the incoming administration to review the rules and decide whether or not to rescind or impose them. While everyone expects the President Elect to issue a delay order, nobody knows what his administration’s likely response to this particular rule will be. In addition, HRSA has promised its final “Mega Guidance” this year, but as guidance it is not subject to any “midnight regulation” clawback – and it remains to be seen whether this omnibus guidance will be released at all.
In this time of uncertainty, we are right there with our clients. While we don’t have a way of knowing what the future holds, we are eager to see how it all shakes out.
Develop Your 340B Strategy
CiiTA has, through extensive experience, developed a set of best practices to help guide you through the creation of your 340B strategy. Download our process document to facilitate the development of your strategy.