CMS Removes Protected Classes Changes in Part D Final Rule

The Centers for Medicare and Medicaid Services (CMS) issued a final rule that makes no changes to the current six protected classes policy — completely eliminating the potentially damaging changes included in a proposed rule released several months earlier. Instead, the agency finalized current practices that allow for prior authorization (PA) and step therapy (ST) to only be used within the protected classes for new starts.  Also consistent with current practice, antiretrovirals remain excluded from utilization management altogether. Importantly, CMS did not finalize exceptions for new formulations of existing drugs or drugs whose prices increase above the urban consumer price index (CPI-U). 

---

“Medicare beneficiaries with the most complex, chronic conditions are breathing a sigh of relief,” Chuck Ingoglia, the Executive Director of the Partnership said in a statement. “This rule cements the protected classes policy as an essential patient safeguard in Medicare’s prescription drug program."