CMS Reverses Formulary Design Rule Starting in 2020. Get Ready Now

The Centers for Medicare and Medicaid Services has reversed its rule prohibiting formulary design that would expand prescription drug choices for Part D health plans and their members.

CMS in August announced that starting in 2020 it will allow Medicare Part D plan sponsors to implement indication-based formulary design. That means plans can cover specific indications of a drug and negotiate lower drug prices, according to a CMS statement.

This is good news.

What is indication-based formulary design? It’s a formulary management tool that allows health plans to tailor on-formulary coverage of drugs predicated on specific indications. Under this type of formulary design, health plans have the ability to negotiate formulary coverage based on specific indications.

Currently, CMS requires Part D plans to cover a drug for every indication approved by the U.S. Food and Drug Administration. The only exceptions are drugs used for treatments statutorily excluded from Part D coverage.

The current authorization criteria is complex at best, and preferred formulary indications must be included in coverage. Medicare Part D plan sponsors are able to use utilization management tools, such as step therapy and prior authorization requirements to promote cost-effective drug therapy by encouraging the use of preferred formulary agents.

According to CMS, the change essentially will give Medicare Part D the power to tailor which drugs are on their formulary by specific indications. They will in turn have additional negotiating leverage with manufacturers, CMS says, which can reduce beneficiary and program costs. As CMS says: “If a Medicare Part D plan sponsor chooses to tailor on-formulary coverage of drugs to certain indications, it must ensure that there is another therapeutically similar drug on the formulary for the non-covered indication in order to meet the anti-discrimination requirements described in section 1860D-11(e)(2)(D)(i) of the Social Security Act.”

The change will likely promote diversity of formularies, which means patients will have greater access to lower drug costs, which promotes better health in the long run. Patients also won’t have to rely on an appeal to get the type of drug treatment they need, CMS says.

Plans should now begin to plan the steps they will be required to take to ensure compliance. Part D sponsors will have to update their applicable CY 2020 beneficiary materials to ensure that the presence of indication limitations is displayed to prospective enrollees. If a Medicare Part D plan sponsor opts to implement indication-based formulary design for CY 2020, the plan must disclose that some drugs may be subject to these requirements in the plan’s Annual Notice of Change (ANOC) and Evidence of Coverage (EOC) documents.

It’s going to be a lot of work – complicated work that many plans don’t have the time or expertise to accomplish properly. That’s where Tier 1 Pharmacy Consulting can help.

The Tier 1 team will ensure CMS compliance by developing and reviewing all of the formularies and updating marketing materials. Contact us today.

About Tier 1 

Tier 1 Pharmacy Consulting is a Denver, Colorado-based pharmacy benefit consulting firm offering customized services to healthcare plans that offer prescription drug benefits. Whether your health plan is big or small, Tier 1 offers strategic, cost-saving solutions that boost the plan’s overall value and help its members by providing high quality care.

Tier 1’s founder is a clinical pharmacist with more than a decade of experience in pharmacy benefit management. We are passionate about collaborating and developing effective strategies to improve health plan outcomes.

Tier 1 offers health plans a new perspective on how to manage their pharmacy benefit. Our team is made up of experts who strive to make effective plans even stronger and fill in any gaps due to a lack of time or resources.

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