New CMS Preclusion List Policy Explained

New CMS Preclusion List Policy Explained

A final rule coming from the Centers for Medicare & Medicaid Services (CMS) was published in the Office of the Federal Register last April 16, 2018. The rule authorizes Part D plan sponsors to install programs for better drug management.


It involves the creation of a Preclusion List which is to go live on January 1, 2019. Streamline Verify contacted the CMS to request for some clarification on some of these updated provisions. The preclusion list will not be available to the public and will only be accessible to Plan D sponsors and MA plans. We will continue to monitor any changes to safeguard the compliance requirements of our clients.

Introducing a Preclusion List will affect certain stakeholders. The rule revises Part C and Part D regulations as well as the Medicare Advantage (MA) program in order to carry out particular parts of the Comprehensive Addiction and Recovery Act (CARA). Such modifications aims to decrease the incidences of opioid overdose or abuse but would still provide beneficiaries with a means to gain assistance through essential treatment opportunities.

Making it easier

Enrollment in Medicare is no longer required for prescribers of Part D drugs in order for such drugs to be covered. It also applies to providers of Medicare Advantage (MA) services and items received by beneficiaries through an MA organization. In its place, Part D plan sponsors may now reject pharmacy claims on Part D drugs should its prescriber appear on the Preclusion List. A Part D plan sponsor may instruct its pharmacy benefit manager to do the same. Providers who are on the Preclusion List will also disqualify the MA service rendered or item received through such individuals or entities from CMS coverage. MA organizations can rightfully deny payment claims for such services or items.

This must not however hinder the access of Part D beneficiaries to medication they require. As a safeguard, beneficiary claims for reimbursement even if based on providers appearing on the Preclusion List cannot be rejected outright. Before doing so, Part D plan sponsors should have a provisional supply of such drug for at least 90 days. They must also furnish the beneficiary with a written notice of the drug’s coverage on a provisional basis.

Preclusion list qualifications

The CMS Preclusion List will essentially be divided into two categories. First are individuals and entities which have their enrollment status revoked in the Medicare program due to the reasons provided under 42 CFR 424.535. This must be coupled with an active reenrollment bar status along with the determination by the CMS that the conduct leading to the revocation is contrary to the Medicare program’s best interests. The second category includes even those prescribers who have yet to enroll in the Medicare program but has been involved in acts that would result in their revocation had they been enrolled. This must also be combined by a CMS decision that such conduct was disadvantageous to the best interests of the Medicare program.

Such modification replaces the need to enroll in Medicare for prescribers of Part D drugs as well as providers of MA services and items. The implementation of a Preclusion List in its place is a refinement of the program without weakening its integrity.

Detection responsibility

To dispense with enrolling in Medicare would necessarily still require Plan D sponsors and MA plans to check if Part D drug prescribers and MA services and items providers are on the CMS Preclusion List. This list is consistently being updated by the CMS. Streamline Verify however is actively following these changes to ensure that its clients are in conformity with the rules. The CMS would have to look into its different internal systems to locate the individuals and entities whose enrollment status was revoked in the past. This would need to be cross-checked with a database of those having a reenrollment bar status. Perhaps the most challenging aspect of this new process is inspecting the history of Part D drug prescribers and MA services and items providers. Their past conduct should not be considered to revoke their enrollment even if they are not actually on the program.

Notification process

A letter will be sent by Medicare Administrative Contractors (MACs) to those providers and suppliers who are on the Preclusion List. This will specify the reason why they are included, the period of time under preclusion and the appeal rights available to the concerned providers and suppliers. Such letter will be forwarded to the National Plan and Provider Enumeration System (NPPES) mailing address or to their Provider Enrollment Chain and Ownership System (PECOS) correspondence address.

About Frank Strafford