ASNC Cautions CMS About Part B Demo Implications for Nuclear Agents

On March 11, 2016, the Centers for Medicare & Medicaid Services (CMS) released for public comment a proposed five-year demonstration project that would test whether alternative payment designs for Part B drugs will lead to a reduction in Medicare expenditures. Concerned about the lack of transparency during the development of the proposed demonstration and how the proposal could affect future payment for diagnostic agents used in Nuclear Cardiology, ASNC submitted comments  asking CMS to not move forward with the Part B drug model until there has been further engagement by CMS with stakeholders, including the cardiac imaging community.   
In its letter, ASNC expressed reservation about CMS's capability to appropriately evaluate the effect of including radiopharmaceutical and stress agents in the Part B drug model on patient quality of care. Specifically, ASNC stated that CMS must have mechanisms in place to parse out the extent to which a patient's outcome is influenced by the diagnostic test, including diagnostic agents used, or the subsequent treatment.

While CMS proposes to exempt from the Part B drug model those drugs that are reported by the Food and Drug Administration to be in short supply, ASNC asked CMS to also exempt drugs (such as MO-99) that are vulnerable to shortage. 

CMS's proposal has received strong reactions from members of Congress. In early May, 242 members of Congress, nearly all Republican, sent a letter  to CMS asking that the proposed regulation be withdrawn. In the letter, lawmakers cited the failure of CMS to explain in its proposal how it will assess quality of care during the model or in its final evaluation.  A number of congressional Democrats are rising in support of the demonstration or asking CMS to scale back the scope of the demonstration.

Earlier this month, ASNC Immediate Past President David Wolinsky, MD, MASNC, and ASNC Board Member Lawrence Phillips, MD, FASNC, traveled to Capitol Hill to highlight the potential implications of including nuclear cardiac imaging diagnostic agents, including radiopharmaceuticals and stress agents, in the Part B drug demonstration. 

See the full text of ASNC's comments letter