Response to 30-day Comments

Document (specify notice, instructions, burden estimates)	Page #	Comment (commenter and summary of comment)	CMS Response
Notice	1	America’s Health Insurance Plans, Mark Hamelburg “Why did we deny your request?” The agency is proposing to require plans to include specific language in the denial rationale section when a prescription drug is denied under Part D and is or may be covered under Medicare Parts A or B. We reiterate our concerns with CMS’s proposal as it relates to MA-PD plans. In the 2017 Call Letter, CMS indicated that the agency intends to develop and issue subregulatory guidance that would provide CMS’s expectations for MA-PD plans regarding coordination of benefits when a prescription drug may be covered under Parts A, B or D. It might address, for example, the appropriate timeframe that must be met for a determination about a drug which is not a Part D-covered drug, but may be covered under Part B, pending the plan’s medical review. Since the subregulatory guidance could directly impact the Notice of Denial language and decision timelines, we continue to believe it is premature for CMS to address the topic through the Notice of Denial. We again recommend that CMS not move forward with its proposed language until plans have an opportunity to review and comment on the applicable subregulatory guidance.	The MA-PD instruction for B v. D drugs is not a new addition to the Part D denial notice; however, we have added language clarifying that the language related to approval under Part B is only inserted “if applicable.”  CMS will not be making any additional changes to the Denial Notice at this time, and burden estimates for this notice have not been changed as a result of the additional clarifying language.