The Department of Health and Human Services (HHS) released their regulatory agenda recently, which applies to all pending regulatory actions. This included the Medicare Part B Drug Payment Model that CMS proposed in March. As per the agenda, the date for the final rule’s publication is March 11, 2019. However, CMS earlier said that they do not plan to publish the rule by the deadline. So, the amendment is that CMS can delay the implementation of the proposal for three years, but not beyond that.
CMS proposes a two-phased approach for changing the way physicians are reimbursed. Physicians are reimbursed under Part B for drugs given from their clinics. Medicare is reimbursing the providers at 106% of the ASP (average sales price) of a medicine. The first phase of the proposal decreases this to 102.5% and adds a flat fee of $16.8 for each drug that is used.
The second phase is aimed at implementing many value based purchasing options. CMS proposes to start the first testing phase of the model by the second half of 2016, and the second phase of testing will start in early 2017. HHS supports this, but it cannot go live until all the comments are considered.
A final rule can be issued only after considering all the comments. The period for public commenting expired in May and it is expected that CMS got numerous comments. CMS will take time to review all these comments.
Apart from this, Obama administration gets only a short time period to finish the regulatory agenda. Else, the new administration may disagree with the proposal and may withdraw the same if it is not finalized. From all this, it can be safely assumed that CMS aims to finalize the proposal before the end of 2016.