subscribe now
Not getting email updates?

The CMS Final Rule: What Medicare Part D Plan Sponsors Need to Know for 2019

September 20, 2018

The experts on the EnvisionRx Compliance and Ethics team have extensively reviewed the Centers for Medicare and Medicaid Services (CMS) Final Rule on Medicare Advantage and Part D program updates and have highlighted key points that may impact you in the next plan year.

Part D Sponsors Can Help Fight the Opioid Crisis

Over the past decade, the misuse of pain medication in the U.S. has become an issue so widespread that it is being addressed by CMS through the implementation of the Comprehensive Addiction and Recovery Act of 2016 (CARA). CARA enables Part D sponsors to implement drug management programs and become a part of the solution, encouraging safer prescribing and dispensing practices of pain medications. Part D sponsors can now limit at-risk members' access to coverage for frequently abused drugs, like opioids and benzodiazepines, through reviews of past opioid use and implementing member limits on pharmacies and prescribers. Aspects of CARA that impact plan sponsors include:

  • A new definition to determine if a member is considered at-risk. Criteria analyzed includes quantity of opioid prescriptions, number of prescribers and/or pharmacies utilized, as well as retrospective Part D Drug Utilization Review (DUR) to show past opioid usage and trends.
  • A ‘lock-in’ that limits at-risk members’ access to multiple pharmacies and prescribers through the use of member-specific point-of-sale claim edits.
  • An exemption on opioid limits for members receiving palliative, end-of-life or hospice care, and those in long-term care settings.
  • A limit to the Special Enrollment Period (SEP) for dual or low income subsidy (LIS) eligible members identified as at-risk for prescription drug abuse.

Tiering Exceptions Will Help Members Save Costs

CMS has revised the existing policy to clarify requirements for how tiering exceptions are to be adjudicated and effectuated. New tiering changes will allow patients to receive higher tier drugs at a lower tier cost, if lower tier options are deemed less effective by their prescriber. Approved tiering exceptions for brand name drugs will generally be assigned to the lowest tier with brand name alternatives, and tiering exceptions for biological products will generally be assigned to the lowest tier associated with biological alternatives.


Tiers Type of drugs Drug example
Tier 1 all generics and authorized generics Warfarin sodium
Tier 2 generics and brands Pradaxa®
Tier 3 preferred brands Xarelto®
Tier 4 non-preferred brands Eliquis®


In our example, if a prescriber indicates the preferred drugs on the lower tiers (Xarelto and Pradaxa) would be less effective or have adverse effects for a patient, then the brand name drug can be approved to the lowest available cost-sharing tier.

Therefore a member can receive Eliquis, a Tier 4 drug, at a Tier 2 cost because that is the lowest cost-sharing tier with brand name drugs. Eliquis could not be approved to Tier 1 because this tier does not include any brand name drugs.

Less Medication Waste Generated by Members Leaving Long-Term Care

In order to reduce waste, CMS is shortening the medication supply provided to members leaving the long-term care setting from 90-days to one month. This aligns with the transition fill (a one-time supply of a drug the member is taking) provided in the outpatient care setting.

More Point-of-Sale Savings through Use of Generic Substitutions

As a cost-saving measure for both plan sponsors and members, CMS will now allow Part D sponsors to immediately substitute newly-available therapeutically equivalent generics for brand name drugs if they meet certain requirements, such as:

  • The generic must be therapeutically equivalent to the brand that is being removed, must be added to the same or lower cost-sharing tier, and must have the same or less-restrictive utilization management criteria.
  • The generic was not available on the market when the plan sponsor submitted its initial formulary for CMS approval.
  • Provide advance notice to CMS and other specified entities.
  • Advise enrollees beforehand that such changes can occur without a specific advance notice.
  • Provide information to affected enrollees at a later date about any specific generic substitutions that have occurred, as opposed to the previous 60-day advance notice requirement.

Plans Have More Time to Issue Decisions for Appeal Requests

CMS is lengthening the time allowed for adjudicating enrollee payment appeal requests at the redetermination and independent review entity (IRE) reconsideration levels. The maximum timeframe will increase from seven to 14 calendar days. This will allow plans more time to review payment requests when a member has already received the drug, or allow plans to prioritize cases where the member has not yet received the drug.

Preclusion List Implemented for Prescribers, Individuals and Entities

CMS is eliminating the prescriber and provider enrollment requirement for Part C and Part D, and instead is compiling a simpler ‘preclusion list’ of prescribers, individuals, and entities. This will allow for a list that is shorter and easier to understand. Those included on the preclusion list fall within one of the following categories:

  • Currently revoked from Medicare.
  • Under an active reenrollment bar and CMS determines that the conduct that led to the revocation is detrimental to the best interests of the Medicare program.
  • Engaged in behavior for which CMS could have revoked the prescriber, individual, or entity to the extent applicable if they had been enrolled in Medicare.

Updated Marketing Guidelines Will Not Impact PBM-Related Functions

Recently, CMS released the updated Medicare marketing guidelines for 2019 under a new name, Medicare Communications and Marketing Guidelines. The EnvisionRx Compliance team reviewed this year’s edits and determined that none of the changes would present a significant impact to pharmacy benefit manager (PBM) related functions at this time.

A Knowledgeable Team Improves Outcomes and Your Bottom Line

Regulations, quality, and member experiences are all intertwined, and the more you know, the better experience you can deliver. A thorough understanding of CMS policies and a partnership with the right PBM can help you meet all government guidelines and keep members a top priority.

With a team of industry experts and a flexible business model, EnvisionRx is in a unique position to serve as an extension of your plan’s own team. EnvisionRx provides unprecedented support by working with you to strategically balance the needs of your members, the needs of your business, and the requirements of our government to achieve the very best outcomes for both plan sponsors and patients.

Take the next step. Learn how you can achieve compliance effectiveness in your program. Download our compliance guide.

Download Compliance Guide Bottom Banner v2
register blog graphic-09272018_v4