January 14, 2011 

Ajit Jillavenkatesa 

100 Bureau Drive 

Stop 1060 

Gaithersburg, MD 20899–1060 

301–975–8519 

ajit.jilla@nist.gov

Comments should be sent to SOS_RFI@nist.gov with the subject line ‘‘Standardization feedback for SubCommittee on Standards.’’ 

Re: Standardization feedback for Sub-Committee on Standards

Dear NIST; 

The National Council for Prescription Drug Programs (NCPDP) submits the following comments 

regarding the Department of Commerce, National Institute of Standards and Technology [Docket 

No. 0909100442–0563–02] Effectiveness of Federal Agency Participation in Standardization in 

Select Technology Sectors for National Science and Technology Council’s Sub-Committee on 

Standardization Request for Information. 

NCPDP is a not-for-profit ANSI-accredited Standards Development Organization consisting of 

more than 1,550 members who represent drug manufacturers, chain and independent 

pharmacies, drug wholesalers, insurers, mail order prescription drug companies, claims 

processors, pharmacy benefit managers, physician services organizations, prescription drug 

providers, software vendors, telecommunication vendors, service organizations, government 

agencies and other parties interested in electronic standardization within the pharmacy services 

sector of the health care industry. 

For direct inquiries or questions related to this letter, please contact

Lynne Gilbertson 

Vice President, Standards Development 

NCPDP 

Direct: 

1803 Longview Drive 

Mount Juliet, TN 37122 

P: (615) 754-0445 

E: lgilbertson@ncpdp.org 

Sincerely, 

Lee Ann C. Stember 

President 

National Council for Prescription Drug Programs (NCPDP) 

9240 E. Raintree Drive 

Scottsdale, AZ 85260 

(480) 477-1000 x 108
NCPDP Response to Standardization feedback for Sub-Committee on Standards

 Page 2 

cc: NCPDP Board of Trustees 

The Sub-Committee on Standards is specifically interested in comments that address the questions below as they relate 

to the following technologies: 

1. Smart Grid. 

2. Health Information Technology. 

3. Cyber Security. 

4. Emergency Communications Interoperability. 

5. Radioactivity Detectors and Radiation Monitors (ANSI N42.3x and N42.4x). 

6. Other technologies involving significant Federal agency participation in standards setting. 

NCPDP Response: 

NCPDP’s comments will be focused on 2. Health Information Technology and 4. 

Emergency Communications Interoperability. 

 

4. Emergency Communications Interoperability 

NCPDP would like to make you aware of the significant industry collaborations of 

RxResponse (www.rxresponse.org) and ICERx (www.icerx.org) for emergency situations. 

Rx Response partners work with local, state and federal officials as well as 

volunteer organizations to help support the continued delivery of medicines to 

people who need them in the event of such an emergency – whether it is caused 

by a natural disaster, terrorist incident or health emergency such as a 

pandemic. Rx Response provides an information-sharing and problem-solving 

forum for the private pharmaceutical supply system, disaster relief agencies and 

government to help ensure the continued delivery of critical medicines to patients 

whose health is threatened by a severe public health emergency. Rx Response 

relies on the existing pharmaceutical supply system to provide for the continued 

flow of medicine in a major public health emergency. This collaboration consists 

of private and public organizations, federal agencies, and NCPDP is proud to be 

a contributor. 

ICERx.org (In Case of Emergency Prescription Database) is a public-service 

online resource developed by the healthcare industry to help ensure continuity of 

quality care for the victims of future disasters. Once authenticated, licensed 

prescribers and pharmacists caring for patients in an emergency situation will be 

able to securely access a patient’s medication history. 

Recognizing that stakeholders participate in standards-setting activities for varying reasons, and in order to evaluate the 

effectiveness of Federal agencies’ participation in standards-setting efforts led by the private sector, the Sub-Committee 

invites organizations to provide information on their participation, and their perceptions of Federal participation in 

standards-setting activities related to the case-study technologies listed above, as well as the current status of the 

standardization process for these technologies. The Sub-Committee is interested in better understanding: Who 

participates in standards-setting activities? What are the most important reasons for participation? What are the benefits 

of developing standards for this sector? How do the standards impact organizations and their competitiveness? How has 

standardization spurred innovation in the technology sector(s) that is the subject of your comment? What is the current 

phase of the standards development process for this technology? How has the process worked so far? When developing 

standards, how are the standards-setting processes managed and coordinated? Is there a strategic plan that identifies the 

standards needs and defines the standards development life cycle? Are there barriers to developing high level strategies 

for standard-setting activities? 

NCPDP Response: 

NCPDP takes its mission very seriously to bring together the different stakeholders in 

health care, specifically pharmacy and the electronic prescribing industry sectors to solve 

industry business requirements. It cannot be stressed enough that federal and state 

agencies need to be actively involved in the standards development process. 

Specific collaborations include working with the FDA representative on the National Drug 

Code (NDC), the Structured Product Label (SPL), the Medication Guides (MedGuides), 

and an Overfill issue. 
NCPDP Response to Standardization feedback for Sub-Committee on Standards

 Page 3 

The Medicare Part D program has been successful in part due to the overwhelming 

collaboration of the industry with the CMS staff to address questions and problems, and 

to discuss upcoming and future considerations before implementation. This has led to 

questions being addressed pre-implementation versus post-implementation, clearer 

guidance being published, and successful collaboration amongst organizations and with 

CMS – all leading to better processes in patient care. NCPDP has also witnessed an 

increase in participation from state agencies as they are directly impacted by Medicare 

Part D processes. 

The electronic prescribing industry has always collaborated to bring united 

recommendations forward to NCVHS, HHS and the DEA. NCPDP worked with NIST 

representatives to provide timely, concise, meaningful use test criteria for electronic 

prescribing and NCPDP continues to assist with questions for timely support. The VA has 

been an active participant and collaborator on modeling foundations for standards in 

NCPDP. Representation from the NLM on RxNorm has been extremely valuable for 

building collaboration with drug database companies and assisting the industry in 

answering questions regarding the use of RxNorm vocabulary in electronic prescribing 

functions. This collaboration resulted in consistent recommendations for NCPDP 

standards being brought forward and approved by the industry. Participants from NCI has 

been invaluable in creating subsets of medication terminology for use in electronic 

prescribing, in providing educational information on the use of the terminology, and 

answering questions. 

NCPDP sincerely values the representatives from the agencies who are able to 

participate as members. These members value the privileges of membership – access to 

all the documents NCPDP produces, free attendance at NCPDP work group meetings, 

member rates at educational and conference events, networking opportunities, and other 

member benefits. Much of NCPDP work is done via task groups under the auspices of 

the work groups. Task groups meet via conference calls and webinars. NCPDP task 

groups are open to any materially interested party, whether member or not, so that 

subject matter experts may participate in work underway. We value their expertise in 

contributing to work products that reflect industry input. These collaborations bring 

forward different perspectives and have provided further networking opportunities for 

entities with similar interests. 

NCPDP cannot stress the importance of these entities participating as members, and 

bringing subject matter expertise to the task group calls. When NCPDP receives 

questions from the industry, a relationship is established to start the dialogue and find a 

solution. Documentation can then be updated to assist implementers with similar 

questions. 

Intellectual Property 

NCPDP Response: 

NCPDP standards documents are copyrighted. They represent the work of the 

membership body. NCPDP receives some of its funding from membership, which allows 

us to offer other benefits to the members at no cost or a reasonable cost. Members may 

copy and use the work or any part thereof in connection with the business purposes of 

the Council members. The work may not be changed or altered and may not be sold, 

used or exploited for commercial purposes. 

The success and limitations of standards-setting activities and the associated outcomes may be studied, understood and 

implemented for continuous process improvement. Such improvements can help ensure that Federal agencies 

participation in standards activities is cost-effective and will lead to optimal results. 

NCPDP Response: 

NCPDP recognizes the importance of representation from the agencies participating as 

members, and bringing subject matter expertise to the task group calls. The unique 

needs of the agencies are part of the discussion when standards are being developed or 
NCPDP Response to Standardization feedback for Sub-Committee on Standards

 Page 4 

problems are being resolved. When NCPDP receives questions from the industry, a 

relationship is established to start the dialogue and to find a solution. The networking 

opportunities participation in NCPDP provides are extremely important to all entities. Our 

collaborative goals are to use standards and vocabularies in a consistent manner to 

provide patient care.