CMS is drawing mixed responses to its Nov. 16 release of proposed policy revisions to the Medicare Advantage (MA) and Medicare Part D programs for 2019. The Pharmaceutical Care Management Association (PCMA), said in a statement the next day that, while it continues to review the agency’s lengthy proposal, the group is “initially encouraged by provisions that promote the use of lower-cost generics and biosimilars and make it harder for at-risk patients to go ‘drugstore shopping’ for opioids.” CMS aims to codify the current Part D Opioid Drug Utilization Review (DUR) Policy and Overutilization Monitoring System (OMS) and integrate them with case management, among various proposals.

Yet PCMA, the PBM trade association, was not entirely pleased with its first read of the 713-page draft regulations. New “any willing pharmacy” requirements outlined in CMS’s proposed rule “could put at risk the choice and affordability of preferred pharmacy plans,” the group said. “Protecting the stability of those plan options should be a top priority for regulators.”

CMS said it 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.” CMS said it also aims to refine definitions of retail and mail-order pharmacies.

CMS in its draft rule proposes to:

Allow midyear formulary changes. CMS is seeking more formulary flexibility, allowing Part D plan sponsors, for example, to immediately substitute newly released equivalent generics for brand name drugs at the same or lower cost-sharing. To do so, plans would have to advise enrollees beforehand that such changes can occur without specific advance notice to them. Various analysts point out the balance is between allowing clinically appropriate generic substitutions in a more timely manner and protecting those beneficiaries who require brand name drugs.

Revise Part D tiering exceptions. CMS wants to eliminate the provision allowing plans to exclude a dedicated generic tier from the tiering exceptions process, and set up a framework based on the type of drug requested — whether brand, generic or biological product — and the cost-sharing for applicable alternative drugs. The agency also proposes to clarify appropriate cost-sharing for approved requests when alternatives are on multiple lower tiers, and to codify that authorized generics should be treated as generics for the purpose of tiering exceptions.

Encourage the use of lower cost drug alternatives. CMS is proposing to do this by classifying follow-on biological products as generics for the purposes of cost-sharing for two types of Part D enrollees: those who don’t get the low income subsidy (LIS) and are in the catastrophic portion of the benefit, and subsidized enrollees through all phases of the benefit.

PCMA said it is encouraged that CMS continues to allow plan sponsors the option to use the price concessions they negotiate with manufacturers and drugstores to reduce premiums and other costs. “According to CMS, requiring plans to estimate and apply manufacturer rebates at the point-of-sale would raise premiums by up to $28 billion and taxpayer costs by up to $82 billion over the next decade,” PCMA said. “Such a requirement would also create a windfall for drugmakers, who would pay up to $29 billion less in donut-hole discounts.”

PCMA noted that CMS’s draft document addresses point-of-sale rebates and direct and indirect remuneration (DIR) issues by including a request for information (RFI) in the proposed rule instead of a requirement. CMS is seeking 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.”

Find the rule at