REMS Standards Created by NCPDP


What you need to know now about this standardization and how it affects the industry.

What you need to know now about this standardization and how it affects the industry.

In August 2010, the National Council for Prescription Drug Programs (NCPDP) created a Risk Evaluation and Mitigation Strategies (REMS) Reference Guide, which promulgates critical standards for the software developers who are creating systems to meet the needs of REMS in the pharmacy services sector of health care. The REMS Reference Guide for Telecommunication Standard version 5.1 has 2 objectives:

• To provide industry standards and practical guidelines for software developers as they begin REMS implementation

• To ensure consistent industry standards for implementation

The REMS Reference Guide was created by an accredited organization to deliver a critical message from a key stakeholder group and to legitimize a transaction-based REMS solution. The participants of the task group that assisted in creating the REMS Reference Guide included pharmacies, vendors, pharmaceutical manufacturers, database management companies, clearinghouses, pharmacy benefit managers, payers, and many others.

Pharmacies have a strong desire to standardize and integrate REMS solutions into their workflow processes via an electronic transaction standard. At this point, the question remains—will the FDA take counsel from pharmacies and consider future REMS in terms of the existing systems and the Telecommunication Standard version 5.1?

NCPDP encourages pharmaceutical manufacturers and REMS program sponsors to become members of the NCPDP and participate in the standard-setting process and the generation of future versions the REMS Reference Guide. NCPDP is taking the important first step in creating standards, and potentially eliminating downstream complexity and costs from the REMS implementation system. To further its mission of standardization and to support understanding and adoption of new REMS standards, the NCPDP Educational Committee is exploring Webinars, educational sessions, and full-day conferences on the subject in coming months.

Due to the increasing number of mandated REMS programs and the increasing impact on affected patient populations—notably the proposed class-wide REMS for long-acting and extended release opioids—pharmacists are impacted and anticipate greater potential burden from future REMS programs. As REMS programs become more common, they will ultimately have a greater impact on pharmacies and pharmacists.

Ensuring REMS compliance for products commonly found in retail or specialty pharmacy settings presents pharmacies and program sponsors with several logistical challenges. This guide directly addresses these types of REMS with elements to assure safe use (ETASU). It advances the standards with the goal of integrating these processes into the retail or specialty pharmacist’s workflow and minimizing burden as much as possible, while ensuring all conditions of safe use are consistently met.

The REMS Reference Guide describes how the Telecommunication Standard version 5.1, and more specifically the Billing transaction, is to be used to automate REMS with ETASU requirements. The following graphic depicts this automation that includes a REMS eligibility verification transaction and data capture to fulfill FDA reporting requirements.

The objective of the guide is to describe the standard to support the REMS registration verification, clinical appropriateness editing, counseling documentation, and/or dispensing activity reporting requirements for products with a REMS requiring ETASU.

Providers, Switching Companies, and REMS Administrators Roles and Responsibilities

The communication between providers and product reimbursement adjudicators (processors) is two-way, and the record layout and response for the transmitted prescription billing or service billing requests are defined in the Telecommunication Standard.

A dispensing provider may be a retail pharmacy, mail order pharmacy, specialty pharmacy, physician’s office, clinic, hospital, long-term care facility, or any other entity which dispenses prescription drugs (with a REMS requiring ETASU).

Switching companies receive transactions from providers and intermediaries as they pass these requests from providers to adjudicators. Switching companies often perform format conversions and perform pre-edits, then return an approved or denied response to the provider after verifying eligibility. The reply from the adjudicator also passes through the switching company on its return response to the provider.

The REMS administrator executes the sponsor’s REMS program. Upon receipt of the prescription billing request from the switching company, the REMS administrator determines if the dispensing provider, prescriber, and/or patient registration verification activities have been completed, if patient consultation is required, or any other required ETASU.

An intermediary may be used by dispensing providers to transmit their prescription billing and service billing claims to a claims processor/adjudicator. Intermediaries receive requests from the switching companies or dispensing providers, perform editing and/or messaging, and then pass the request transactions to the appropriate switching company or adjudicator/ processor, or return a denied transaction response to the provider. The reply from the adjudicator/processor may also pass to an intermediary for editing, messaging, and/or data capture on its return to the dispensing provider.

It is important to note that multiple roles may be performed by the same organization depending on agreements and services offered.

Dispensing Provider Responsibilities for REMS

The dispensing provider’s responsibilities include:

• Populate all fields required by the adjudicator/processor

• Submit all optional segments and fields required by the REMS administrator

• Use the same routing paths for associated transactions (eg, billing and reversals)

REMS Administrator Responsibilities

Companies, such as McKesson Specialty Care Solutions, provide administrator services to manufacturers. The REMS administrator’s responsibilities include:

• Perform pharmacy registration verification edits before the billing request is delivered to the adjudicator or provider

• Perform prescriber registration verification edits before the billing request is delivered to the adjudicator or provider

• Perform patient registration verification edits before the billing request is delivered to the adjudicator or provider

• Perform pharmacist registration verification edits before the billing request is delivered to the adjudicator or provider

• Perform clinical appropriateness edits before the billing request is delivered to the adjudicator or provider

• Capture billing and billing reversal activity subsequent to the adjudicator processing the request

• Process service billing requests, match requests, and perform data capture and reporting activities on behalf of the REMS program sponsor

Switching Company Responsibilities for REMS

Companies, such as McKesson’s RelayHealth, provide switching services. The switching company’s responsibilities include:

• Route qualified billing transactions for proprietary REMS eligibility verification

• Interpret the REMS administrator’s response as a data capture only, denial, or approval status

• Deliver the submitted billing request to the adjudicator when the REMS eligibility verification has been approved

• Format and deliver a denial to the provider when eligibility is not verified via the REMS administrator

• Route qualified reversal transactions for REMS eligibility verification

The NCPDP REMS Reference Guide details the transaction structure for the segments and data elements for verification of each required REMS element. Transaction examples are provided via diagrams for billing requests, plus denial and approval responses.


Standards are important in all segments of health care and REMS will benefit from standardization. I applaud the foresight of the NCPDP members and the organization for leading this important initiative in health care and working to drive and deliver safer more standardized options to the market. SPT

Ms. Morel is vice president and general manager of reimbursement & access services for McKesson Specialty Care Solutions in Scottsdale, Arizona. Morel leads the development and execution of reimbursement strategies and support services, patient assistance programs, risk evaluation and mitigation strategies programs, and other patient- and physician-focused initiatives. She is a nationally recognized expert in health care reimbursement and marketing. With this “Focus on REMS,” Morel joins Specialty Pharmacy Times as the regular REMS columnist and a member of the Editorial Board.

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