Response to Public Comments

60-Day Comment Response Document	Medication Therapy Management Program – Standardized Format, CMS-10396, OMB 0938-1154
Overview of Comments:	We received 4 comments from 3 plan organizations.
Detailed Summary of Comments
Organization	Section	Comment	Commenter's Recommendation	CMS Response	Revised Requirements/Documents	Revised Burden Estimates
MLTSS	General	The increase in program size and burden would not be evenly distributed, and that some plans would be disproportionately affected due to member population and plan type.	CMS should implement the MTM expansion in a more thoughtful, stepwise fashion, broadening the eligibility criteria over several years to provide plans with time and notice to gather the internal and external resources necessary to develop a robust MTM program to more individuals with varied needs, including those who are dually eligible. Alternatively, CMS can also explore making further adjustments to the existing MTM program, such that plans have the resources to provide more intensive care management to those most complex enrollees. Finally, if the MTM program is expanded, this would constitute a significant change to the associated Star Ratings measure, which then would need to be moved to the display page.	We acknowledge that eligibility rates for MTM are not evenly distributed among Part D contracts. Similar to current MTM programs, some contracts may have actual MTM enrollment rates above or below the average rate for the program as a whole. CMS took the cost burden into consideration when developing its policies for this final rule and modified the eligibility criteria to lessen the burden on plans but still provide access to MTM to more beneficiaries.	No	No
Viva Health	General	Simplification of the program should help decrease the cost associated with administering it and help plans accommodate a gradually increased enrollment. However, even with focusing on the CMR, the industry will face challenges due to the changes in the pharmacy industry as pharmacies cut hours and staff to manage costs.	We recommend the program be simplified to remove the more administratively complicated components and focus solely on the comprehensive medication review (CMR).	As a key component of the MTM program, the CMR is also the costliest component as evidenced by our calculations. Therefore, it is unlikely that focusing solely on the CMR would significantly decrease the cost burden. Section 1860D–4(c)(2) of the Act requires MTM programs include specific elements, interventions, and assessments.	No	No
CVS Health	Cost burden	The uneven distribution based on plan type unfairly burdens those plans with higher qualification rates and therefore increased administrative costs. The significant increase in the cost of providing MTM may result in increase in premiums.	Instead of simply ramping up enrollment in a program that is yet to demonstrate its effectiveness, a better approach would be to revisit the current MTM program to make changes that better integrate with the medical benefit, such as allowing direct reimbursement to pharmacists involved in the member’s medical care team for their cognitive clinical services.	We acknowledge that eligibility rates for MTM are not evenly distributed among Part D contracts. Similar to current MTM programs, some contracts may have actual MTM enrollment rates above or below the average rate for the program as a whole. CMS took the cost burden into consideration when developing its policies for this final rule and modified the eligibility criteria to lessen the burden on plans but still provide access to MTM to more beneficiaries.	No	No
CVS Health	Cost burden	We also believe CMS underestimates the time for a pharmacist or other qualified provider to complete the Comprehensive Medication Review (CMR). While the average CMR consultation with the enrollee may take 20-40 minutes, the pharmacist or other qualified provider spends additional time reviewing the case before the consultation with the enrollee and preparing the CMR summary.	A better estimate of the time involved, and thus the cost, is 60 minutes per CMR conducted.	CMS disagrees. The time spent conducting a CMR for the purposes of our burden calculations is an average; as supported by the range of 20 to 60 minutes provided in this comment, 40 minutes is an accurate estimate. CMS considers the preparatory time for the CMR summary to be negligible since most sponsors and MTM providers use an automated system to complete the Standardized Format.	No	No