Big changes could be in store for 2019 Medicare drug plans

CMS is accepting public comment on proposed rule change until January 18, 2018

For the first time in 3 years, the CMS regulatory agenda released a Medicare Advantage and Part D proposed rule. The Part D proposed rule is a platform for presenting major policy changes for public comment.

CMS will accept public comments through January 18, 2018. To view a CMS fact sheet on all the proposed rules, visit

Clarifying ‘any willing pharmacy’ participation

One of the sections of the new proposed rule intends “to clarify that the any willing pharmacy requirement applies to all pharmacies, regardless of how they have organized one or more lines of pharmacy business.” Currently, some Medicare drug plans drive patients towards “preferred” pharmacies, or charge patients higher copays at pharmacies that aren’t “preferred” but may, for example, be more geographically convenient, provide services beyond traditional services, or where they have established relationships with pharmacists. Under the current framework, not all pharmacies may become a “preferred” pharmacy, even if willing to meet a plan’s requirements, because they may not satisfy the plan’s definition of a certain type of pharmacy. Pharmacy groups have long advocated for inclusion of “any willing pharmacy” provisions that allow patients to use any pharmacy that agrees to accept a plan’s conditions. The proposed rule clarifies that Part D plan sponsors may not exclude pharmacies with unique or innovative care delivery models from participating on the basis of not fitting the correct pharmacy type classification. Rather, under the proposed rule, CMS will consider “similarly situated” pharmacies include any pharmacy that has the capability of complying with standard terms and conditions for a pharmacy type.

Addressing DIR fees

Another section of the proposed rule “includes a Request for Information soliciting comment on potential policy approaches for applying some manufacturer rebates and all pharmacy price concessions to the price of a drug at the point of sale,” which would affect direct and indirect renumeration (DIR) fees that claw back pharmacy reimbursements weeks or months after a drug is dispensed. In addition, CMS is soliciting comments on how to effectively design a policy requiring Part D plans to share savings from the rebates they receive with beneficiaries in order to mitigate the effects of DIR fees on costs to both patients and Medicare.

Drug management programs

Passed in July 2016, CARA authorized MA and Part D plan sponsors to establish a drug management program that aim to manage an at-risk beneficiary’s access to frequently abused drugs by locking-in the beneficiary to a selected prescriber(s) and/or network pharmacy(ies). In addition, the proposed rule codifies the current Part D Opioid Drug Utilization Review Policy and Overutilization Monitoring System (OMS) by integrating it with CMS’ proposed regulations for drug management programs.

E-prescribing standards

The proposed rule also updates the electronic standard for Part D plan sponsors to the NCPDP SCRIPT Standard 2017071 by January 1, 2019. The NCPCP script standards are used to exchange information between prescribers, dispensers, intermediaries and Medicare prescription drug plans. E-prescribing remains optional for prescribers and pharmacies.

Generic drug access and other midyear formulary changes

The proposed rule gives sponsors more formulary flexibility, by, for example, allowing the immediate substitution for newly released equivalent generics for brand name drugs at the same or lower cost-sharing if certain requirements are met.