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Department of Health and Human Services


Subcommittee on Standards

Administrative Transaction Standards, Code Sets and Operating Rules
Industry Status of Planning, Transitioning and Implementation

June 17 – 18, 2013

National Center for Health Statistics
3311 Toledo Road
Hyattsville, MD 20782

The National Committee on Vital and Health Statistics Subcommittee on Standards convened a hearing on June 17-18, 2013. The meeting was open to the public and was broadcast live on the internet. A link to the live broadcast is available on the NCVHS homepage.

Committee Members Present

  • Walter G. Suarez, M.D., M.P.H., Co-Chair
  • W. Ob Soonthornsima, Co-Chair
  • Alexandra Goss
  • Linda Kloss, M.A.

Committee Members Absent

  • Raj Chanderraj, M.D., F.A.C.C.
  • William J. Scanlon, Ph.D.

Staff and Liaisons Present

  • Suzie Burke-Bebee, DNP, MSIS, ASPE
  • Kamahanahokulai Farrar for Lorraine T. Doo, M.P.H., CMS, Lead Staff
  • J. Michael Fitzmaurice, Ph.D., AHRQ Liaison
  • Marjorie Greenberg, NCHS/CDC, Exec Secretary
  • Larry A. Green, M.D., Chair, NCVHS National Committee
  • Donna Pickett, RHIA, MPH, NCHS
  • Jessica Porras
  • Jim Sorace, M.D., ASPE
  • Marietta Squire, NCHS
  • Michelle Williamson, R.N., MSIS, CPHIT, NCHS


  • Vivian Auld, NLM
  • Betsy Humphreys, NLM
  • James Scanlon, ASPE
  • Nicole Wilson, VA

Hearing Presenters List

  • Tammy Banks, AMA
  • Sue Bowman, AHIMA
  • Denise Buenning, OESS
  • Cathy Carter, Medicare FFS
  • Dean Cook, OESS
  • Jim Daley, WEDI
  • Jordan Firfer, Florida BCBS
  • Kari Gaare, OESS
  • Annette Gabel, Express Scripts
  • Lynne Gilbertson, NCPDP
  • Denesecia Green, OESS
  • Priscilla Holland, NACHA
  • Mary Hyland, HBMA
  • Tim Kaja, United Health,(via phone)
  • Gwen Lohse, CAQH
  • Holly Louie, HBMA
  • Tim McMullen, Cooperative Exchange
  • Debbi Meisner, Emdeon
  • Benjamin Miller, M.D., U. of Colorado School of Medicine (via phone)
  • Joseph Miller, HIMSS
  • Don Oaks, TN Medicaid (via phone)
  • John Quinn, Accenture
  • Mona Reimers, M.D.
  • Nancy Spector, AMA
  • Debra Strickland, Tibco/Plans
  • Robert Tennant, MGMA
  • Margaret Weiker, X12
  • Dennis Winkler, BCBS Michigan

Other Participants

  • Matthew Albright, CMS
  • Bill Alfano, BCBSA
  • Durwin Day, Healthcare Service Corporation
  • Terry Deutsch, CMS
  • Lauren Fleeger, VA
  • Rachel Foerster, Rachel Foerster & Associates, Ltd.
  • Don Gerdts, MEA/NEA
  • Thomas Harris, BCBS Florida
  • Steven S. Lazarus, BIG
  • Jim McKinley, BCBS Alabama
  • Daryl Regier, American Psychiatric Assn.
  • Dan Rode, AHIMA
  • Kelly Turek, AHIP



  • The Subcommittee on Standards will submit a letter to the full Committee that is intended for the Secretary of HHS confirming agreement with recommended changes being made to the pharmacy claim. Revisions were made at a Subcommittee meeting on June 20, 2013. Suggested edits and clarifying changes by Subcommittee and full Committee members will be incorporated in one modified document that reflects the full scope of change recommendations prior to submission to HHS.
  • The Subcommittee intends to develop a work plan for the remainder of 2013 and for 2014 at the June 20, 2013 meeting, to include potential topics and hearings; what to do about the next HIPAA report; and how to begin to develop a roadmap.
  • Subcommittee leadership will convene a conference call after compiling themes, observations and recommendations in order to produce a formal letter to the full Committee by September 2013.

NOTEPlease refer to PowerPoint presentations and transcript for further information.

Monday, June 17, 2013

Walter G. Suarez, M.D., M.P.H. and W. Ob Soonthornsima, Co-Chairs; and Kamahanahokulani Farrar (for Lorraine Doo)

The purpose of the hearing was to assess the implementation stage of various administrative simplification standards and requirements and to discuss the status of planning for upcoming adoption and standards compliance. It was also an opportunity to hear industry perspectives about the status of HIPAA and the Affordable Care Act and to plan for the next round of standards, particularly focusing on operating rules and ICD-10.

Update from WEDI Executive Steering Committee

2013 WEDI Report Update and Report on WEDI Industry Findings Jim Daley, WEDI


Conjectures were made about the lack of customer readiness (causing compliance delays that in some cases held up ICD-10 efforts), especially among providers and vendors. While more time is needed for end-to-end testing, it is critical to disseminate information about ICD-10 (which clearinghouses are well-positioned to do). As the compliance date is not changing, WEDI recommends partnering with CMS and others to coordinate efforts and address industry concerns. Tools are being developed to help those who have not yet done their assessments.

Much is being done to operationalize insurance exchanges. Regulations are scheduled for completion by October 1, 2014 with a January 1 implementation date. Questions persist about the intricacies of Health Plan Identifiers. New payment models are under development, noting that some issues require standards changes. Security is an ongoing concern. It is important to continually look toward the future.

DSMO Report

  • Annual Report; Change Requests, Reaction to CMS Pilot Nancy Spector, AMA
  • X12 Margaret Weiker, X12
  • NCPDP Lynne Gilbertson, NCPDP



There have been many discussions about how complimentary aspects of standards and operating rules will work. The process for submitting changes to the actual operating rule was described. Operating rule requests go directly to CAQH CORE but in gray areas where it is unclear whether a request should go to the standard or operating rule, the DSMO process will examine it from a standards perspective.

In response to a question about specific changes made to standards from adopted operating rules, it was noted that NCPDP had an operating rule guide for the 270/271 used in e-prescribing. The changes (incorporated into Version 6020 of the 270/271) will negate the use of that operating rule document. How will DSMO and CAQH CORE work synergistically in such areas as grandfathering in, closing items out or moving to new standard iterations? This is new territory. Operating rules modifications have not yet come to the DSMO. Many current operating rules (and those that go into effect as of January 1, 2014) are outside the scope of an Implementation Guide. A group effort must ensure that those on the outside understand how things run and that requests are directed to the right place. Communication lines exist between X12 and CORE despite no formal process. ACS X12 examines what CORE has adopted as operating rules and determines whether to make a change (changes are noted in the guidebooks). Section 1104 of the Affordable Care act requires a Standards and Operating Rules Maintenance Review Committee that OESS is developing.

There was further clarification about coordination of CAQH CORE and ASC X12 activities. Two modification and two maintenance requests that were not approved will be incorporated into the next version of those transactions. The SAC Committee of X12 deals with health insurance exchange information. Change requests can be made on the X12 website. An enrollment transaction guide (834) was created specifically for the exchanges as was the 820, addressing payment requests. At present, the 834 adopted under HIPAA is used in the exchanges. A brief description was given of how gap areas are addressed.


The timeline for developing and approving the next X12 version was outlined. A broader consensus is sought with WEDI before X12 makes changes. A recommendation will be made to go to the next version in 2015 although it is more likely to be 2016 due to the piloting timeframe (unless there is more unit- than end-to-end testing). People will begin to enroll in October 2015 and changes will be incorporated into the upcoming version.


An overview was presented with an emphasis on the state of development of upcoming versions and the incorporation of operating rules. The Version D Editorial Reference Guide is an updated quarterly that provides questions, answers, clarifications, examples and typo notifications. In 2012, NCPDP was asked to solve problems in the exchanged prescription drug event files (post-claim reporting information). A request was made for NCVHS to recommend that the NCPDP proposed solutions move forward as soon as possible. NCPDP participation in CORE operating rules was described.

Status of Implementation of 5010, D.O., 3.0

  • Health Plan Perspective Jordan Firfer, Florida BXBS
  • Provider Perspective Annette Gabel, Express Scripts
  • Clearinghouse/Vendors Debbi Meisner, Emdeon
  • Medicaid Don Oaks, TN (via phone)
  • Medicare Cathy Carter, Medicare FFS


(Ms. Meisner) When first published, 6020 did not have change logs. Rather, a comparison from 5010 to 6020 was used that did not describe the change. Since then, X12 has done an excellent job of creating new change logs with business descriptions. Despite differences, the gap analysis has the same information as the change logs. While the gap analysis cannot be published, a SNIP describing the process and derivation of numbers has been published. Medicare has had the same coordination of benefits problem.

Timeframes were discussed with the ideal being the longest possible time period. Florida Blue Cross Blue Shield has been at the mercy of stakeholder readiness for controlled migration. Limited resources have posed challenges to attempts to manage migration flash cuts. Identifying a time period specifically meant for that purpose was recommended for the 70 series change.

The impact of more than 20 percent of providers still submitting 4010 depends upon the vendor. Some vendors provide add-ons to the system or crosswalking solutions. Emdeon and Florida Blue have told its customers to use 5010 in order to support ICD-10 within its message. Different clearinghouses take different approaches. Some (such as TennCare) stay away from crosswalks when possible. Emdeon does not think it has the medical records to make the determination. There is concern about organizations that are not yet moving toward ICD-10. Because ICD-10 will be a “flip-the-switch” process on October 1, 2014, it is difficult to measure industry readiness.

Mr. Oaks described little disruption to the readiness process when they ignored the second delay and moved ahead with 5010/D.0 enforcement in Tennessee. Impact was on provider billing and did not cause service delays.

CMS Regulatory Update

  • OESS Denise Buenning, OESS


A question was posed about how to use and share health information exchange data (HL7). A suggestion was made that government entities develop guidelines about strict obligations associated with receiving or passing data forward. A group addressing privacy policy and compliance within CMS’s Office of E-Health Standards and Services is actively involved in data use and interagency agreements between all federal operating divisions as well as outside entities such as Social Security Administration and the IRS.

The value of acknowledgements as transactions was reiterated, noting that NCVHS has formally recommended that HHS adopt standards for acknowledgements transactions. Due to unresolved issues, this will not be part of a 2013 regulatory effort. An attempt is being made to reduce burden of the healthcare community. OESS will get a list of acknowledgements concerns to the Subcommittee. It is helpful to have time to do controlled migrations and test acknowledgements. NCVHS plans to further promote a letter to the Secretary published in November 2012 that described a stewardship framework for uses of health data outside of HIPAA. New ICD-10 data will be another lever for big data. CMS has a data governance board that addresses data release and accompanying policies.

How can NCVHS help address the challenges of developing a viable framework for data governance? A suggestion was made for the Standards and Privacy, Confidentiality and Security Subcommittees to meet with CMS staff members who negotiate privacy agreements. It is difficult to know who is responsible for ensuring that data are safe and secure when they leave one system for another. OESS would like to participate in a hearing on the stewardship framework. Longer term considerations include ensuring that study conclusions are statistically accurate.

Public Comment None.

Adjournment, Day One: 5:00 p.m.

Tuesday, June 18, 2013

State of Development and Implementation of Operating Rules

PART Preparing for Implementation

  • Authoring Entity Gwen Lohse, CAQH
  • Providers Tammy Banks, AMA
  • Mona Reimers, M.D.
  • Clearinghouse/Vendors Tim McMullen, Cooperative Exchange
  • Health Plan Vendor Debra Strickland, Tibco/Plans
  • Health Plan Tim Kaja, United Health (via phone)
  • Standards Organization Priscilla Holland, NACHA
  • CMS Cathy Carter, Medicare FFS
  • HBMA Mary Hyland, HBMA


A discussion about how to update the operating rules ensued. A definition of maintenance would be useful: is it refining or adding? How is input gathered from those not directly involved and how can one vote per entity be maintained? More generally, how can participation be encouraged? Maintenance within the context of standards, operating rules and code sets includes refinement (substantive and non-substantive), addition and retirement. But how will maintenance work in the operating world with a defined set of rules as of January 1, 2014 for eligibility and claims status?

CAQH is not adding due to limited resources and because the industry is still implementing. To date, there are no substantive changes. A better job could be done of seeking outside public comment. Challenges associated with the CARCs and the RARCs were noted. Lack of compliance continues to be a major challenge. Operating rules require a massive focus on maintenance. Although the process can be improved, the rules will roll into the next version of the standards. Longer-term, is there an entity willing to assume responsibility for the code combinations, business scenarios and definitions?

A suggestion was made to convene a focused conversation about X509 certificates and how they are tracked with individual identify issues within web services (in a federated environment). NVCHS should consider a more holistic approach to addressing the next set of operating rules. The Cooperative Exchange could advise about the claims process. More funding is needed for a holistic effort and for analytics reporting. EHR data and provider/patient interactions must be examined in order to determine how that data get reused.

In considering a restructure, the Insurance Subcommittee at ASC X12 has moved away from transaction specifics toward business functions. In a business function, what are the benefits and data elements associated with benefits? Entity (IDs, names, demographics) and direct and indirect data harmonization are also under consideration. A discussion ensued about how X12 coordinates with HL7 and NCPDP, given different standard bodies (liaisons were noted). Since adoption is the mutual purpose of a holistic view, it is important to examine the analytics that support adoption.

Ms. Lohse described the core multi-million dollar effort (initially voluntary) as currently mandated to encourage membership with low fees (less than 10 percent of CORE’s costs are covered by participating fees). The new CAQH CORE board governance is a multi-stakeholder with one vote per entity. Much time has been spent on analytics, including research analysis of each rule and an efficiency index that tracks each transaction. An estimated three to four times more funding is needed to move the process forward holistically.

Ongoing themes include: many entities, especially smaller payers and practices, are struggling and therefore not really using capabilities that accompany transactions (noting other options to achieve eligibility claims status). Overlapping standards and rules in the regulatory environment can limit providers from obtaining needed reimbursement information. A suggestion was made to develop a provider hotline for troubleshooting purposes. From that, a compilation of lessons learned could be created. At present, there is no trustworthy single source available to help those in need of assistance.

What is the administrative simplification roadmap and what are its priorities relative to the standards, operating rules and convergence of clinical and administrative data? WEDI has a wide scale effort underway to examine these issues while CAQH requires more funding to do so. Functionality is another concern: practice management systems must be covered as business associates that comply with the requirements in order to obtain the investment that payers make to providers. These practices must be incorporated into the workflow behind the scenes. Removing options will not help but providing interoperable solutions to providers will make a positive difference.

The CORE board strongly encourages certification from different practice management systems. The importance of taking advantage of real time connectivity was noted. A roadmap for attachments must be allowed within the operating rules. Discussion ensued about the challenges of the 90-day rule within HIEs. More education from CMS about CORE rules is needed and a workflow change is necessary in provider offices. It is essential to agree on a roadmap that clarifies priorities and messaging points to stakeholders. Information must be imparted to the Exchanges clearly and concisely.

ICD-10 Planning, Testing, Implementation

Part I: Preparing for Implementation

  • Testing Pilot Kari Gaare, Dean Cook and Denesecia Green, OESS
  • Health Plan Dennis Winkler, BCBS Michigan
  • Clearinghouse/Vendors Tim McMullen, Cooperative Exchange
  • Providers Rob Tennant, MGMA
  • Vendor Holly Louie, HBMA
  • Testing Pilot Joseph Miller, HIMSS


CMS has programmatic as well as policy and regulatory functions. The ICD-10 implementation date will not change. Testing (end-to-end or content-based) is important and should be data driven and real with airtight clinical scenarios. Definitions should be consistent across entities. There was never a plan within ICD-10 to give providers remittance advice, which has caused unhappiness in the fee-for-service Medicare environment. Big differences in testing interpretation were noted and a year of rigorous testing would be useful. CMS is trying to be realistic about what is possible given the environment. Major concerns rest with physicians rather than institutions.

A question was posed about how to address the cumulative prevalence of less common diseases. A core set of test case scenarios was developed with the idea that payers and providers would add to such cases. Core cases are intended as starting points. A step-by-step guideline is needed to delineate how to use newly developed tools (e.g., end-to-end testing and case scenarios). Despite progress, substantial data readiness is in question.

Questions were posed about how to make testing breakthroughs usable on the ground and how to underline their urgency. There is no guarantee that every payer will pay a claim based upon developed clinical scenarios. Practices must be able to test directly with their health plans. Because smallest providers are the most vulnerable, why not utilize the Regional Extension Centers [RECS] structure that is already in place and considered reliable (noting that funding is needed to support the RECs)? A recommendation was made to invest in ICD-10 at the front end to insure a smooth transition. BCBS of Michigan has made a scenarios “cheat sheet” available to other plans that, while limited, targets high-risk, high-volume, high dollar situations. Their communication strategy targets a presentation generic to ICD-10 including questions to specialties associated with ICD-10 (to increase awareness within specialties).

One source of concern in the provider community has to do with thousands of payer policies that drive payment off of the ICD-10 code. Physicians will be more engaged if they know they can test and also get paid. WEDI and HIMSS codes and clinical scenarios, to be published on HIMSS ICD-10 playbook, will be available to all. Even the RECs require training and support despite knowing and having the trust of the provider community. Alternatives to using RECs were noted although none were specifically mentioned.

A discussion followed about how to address scenarios within primary care that lack precise diagnoses. ICD-10 has many more symptoms and clinical finding codes than previously. Even payers recognize that diagnoses are sometimes vague; and that codes exist for such categories. However due to limited resources, BCBS of Michigan pursues scenarios that “satisfy the masses.” With regard to pilots, provider feedback about the shift from ICD-9 to ICD-10 is not yet available.

PART II New Uses for ICD-10 Data

  • AHIMA Sue Bowman, AHIMA
  • HL7 John Quinn, Accenture
  • Provider Benjamin Miller, M.D., U. of CO School of Medicine


The usefulness of using metrics to judge the progress of ICD-10 implementation was discussed. Canada, Australia and other countries have gathered ICD-9 to ICD-10 transition baseline data on coding accuracy. There are no known studies in other countries that prove that data were better after ICD-10 implementation. ICD-10 was adopted by other countries approximately twenty years ago. Another distinguishing factor is that the United States uses ICD-10 as a catalyst for justifying reimbursement or documenting care giving for reimbursement. Motivating factors for implementing ICD-10 were discussed.

Education is needed, particularly in informatics and computer science. A lack of adequate physician training in ICD and mental health was also noted. As long as ICD-10 is viewed as the path to payment, it will be relegated to professional coders. Some face-to-face education and webinars are available on the use of ICD-10 and also on the value of the data. AHIMA has had an ICD-10 Summit annually since 2009. This year’s topics included data analytics and coding analysis. Although not everyone attends such events, there is a gradual trend upwards with regard to understanding the data, including mental health. A prediction was made that companies, AHIMA chapters and medical societies will begin physician training programs just before the implementation date.

Maintenance of complex crosswalks was discussed as was the removal of the mental health glossary from ICD-10 CM (due to lack of consistency with mental health practice in the U.S.). DSM-IV and DSM-V are not named on Meaningful Use as a code despite the fact that mental health providers use SNOMED, DSM and ICD as coding schemas, which is challenging. NCVHS can provide guidance and recommendations to address these challenges.

Themes of today’s discussions necessitate further Subcommittee discussion about educational programs for medical schools and training initiatives that establish a framework and leverage work being done to standardize, harmonize and advance the usefulness of the data.

Public Comment I

Differences between DSM-V and ICD-10 were noted. ICD-10 is an international classification system for all disorders. Mental disorders have an absence of biological markers and some other validators found in other areas of medicine. There are vast differences in the rate of schizophrenia and bipolar disorder hospital admissions in different countries. DSM-V includes ICD-9 and ICD-10 codes in parentheses with an automatic crosswalk. An automatic training guide for ICD-10 CM is being distributed to the entire mental health community. Unlike ICD-10, DSM V provides explicit diagnostic criteria that eliminates confusion about the meaning of the codes. The American Psychiatric Association would like to be included in continuing discussions about ICD-10 and mental health issues.

Subcommittee Discussion

Hearing Debriefing and Themes

Ongoing themes included: the need to examine transactions more realistically to fit current business practices; challenges of small practices and payers, especially relative to vendors and cost; the need for awareness, education and even focused handholding; development of a roadmap that tracks changes when they occur and the “tail” of implementations, which impacts milestones.

NCVHS is not likely to hear a recommendation to move to the next version of the HIPAA transactions until 2015 or even 2016. This affects the timeframe for generating proposed rules, noting a six-month adoption window for a new version of a standard (according to HIPAA). The 5010 will be in use until 2018 (estimated). With 5010, the industry is in a good position relative to surveys, reports, payers, Medicare and CMS. Those still using 4010 must move to 5010 in order to comply with ICD-10. The Subcommittee has recommended the adoption of acknowledgements of the industry’s standard transaction but a balance must be struck in terms of timing and requirements overloading. While acknowledgements are desirable, they are not likely to be a priority in CMS’s regulatory agenda through 2014.

A suggestion was made for CMS and the Committee to begin developing the roadmap. The Subcommittee has heard that ICD-10 is too complicated and yet the SNOMED categories are what people use (although it is not an international terminology). The two international standards must work together. Vocabularies and classifications are needed. For data to be useful, documentation of health care must be improved, noting the lack of infrastructure within much of the healthcare system. A case can be made for participation only from within accountable organizations. A solution must be found for smaller practices. It is important to recognize the need for data documentation improvement while appreciating what must be done to accomplish that. How will the information revolution get integrated into the healthcare system?

Other issues of concern involved the updating process – how to keep standards current and optimize the use of technology to simplify processes. An opportunity exists to think out of the box about maintenance and dissemination. Pilot programs are experimenting with updating that acknowledges the myriad of data sources. A suggestion was made for the Subcommittee to commission a report about lessons learned from this large-scale change, to include celebrating successes. A question was raised about whether to have a specific reference to ICD-10 as part of certification. Progress was noted in standardizing quality measures and comparable data can now be obtained. NCVHS and WEDI should ensure an alignment in terms of timeframes, milestones and objectives. For CMS, part of the roadmap includes eHealth; and movement toward an “eHealth University” was noted (i.e., educating particular cohorts or target audience, particularly smaller providers). Small pilots that test assumptions are needed to determine how to leverage CMS, ONC or the industry. These insights can be integrated into the roadmap.

The diagnosis of illness evolves over time and within healthcare system encounters. The success of the healthcare system in delivering quality depends upon meeting individual diagnostic needs across the entire population. Therefore, it would be a mistake to design a more granular code. Rather, more effort should be put into diagnostic and other systems (e.g., pharmacy); and how the codes are rolled up and clustered for patients. Nationally, such clusters should be monitored. Other roadmap issues were raised such as the need for large, representative samples. What can be done to help providers navigate the technology pipeline? A concern about overlapping standards was raised as was the need for coordination across the standards community. Who is governing movement forward in developing and maintaining standards, code sets, operating rules and coordination with academic institutions?

Other concerns included the impact of non-covered entities on providers; roadmap funding; and minimizing change in order to cross-coordinate and avoid duplicating efforts. Sequencing and pacing change efforts are critical. Further discussions are needed about end-to-end testing. A discussion ensued about the complexities involved in CMS’s decision to not do ICD-10 end-to-end testing with individual providers. Operating rules challenges were also raised with regard to compliance and organizational struggles to complete operating rules transitions; maintenance or how change happens and input is received (e.g., DSMO process); and the breadth of operating rules. That is, some of the rules should apply to everything while others might be transaction-specific. In general, transactions reflect a need to communicate business needs. Provider concerns about operating rules include eligibility; limitations in how electronic federal tax (EFT) is done; and the challenge that required credit card payments pose to implementation.

A great concern is the pending enforcement of Operating Rules by January 1, 2014. A message must be sent to the Secretary that underlines the impossibility of meeting this deadline. Work with the industry must produce recommendations prior to implementation that help define, test and understand the value of implementing the operating rules. A prediction of disruption and bad debt is also of concern relative to HIE eligibility and delinquency (moving from a 45- to 90-day period in November 2014). The health insurance marketplace must be factored in. How can ACA, current funding or payment policies (whether Medicare of Medicaid) insure interoperability to business needs? Examining patient care workflow touches upon Meaningful Use (HITECH; HIPPA). The Center for Study of Insurance Operations (CSIO) is developing a map as they solidify their rules in the workflow.

Additional points included: the operating rules process remains too complicated due to advantages created by retaining unnecessary complexity. Although engagement is voluntary, everything must be coordinated and integrated. Challenges persist when a complex adaptive problem is approached with linear strategies. While solving problems by sequencing at the proper pace may not work, there is no choice but to try this strategy. Many do not accept the IOM’s 1999 and 2000 conclusion that there are so many complexities that the system cannot be fixed.

How the work of the Subcommittee on Standards converges with the work of the other NCVHS Subcommittees was raised. The ACA’s primary care extension service would become a new, national resource (that does not have to be federally, state or privately owned). There is a desperate need for assistance in managing the pace and rate of change in the healthcare system. Organizations are not nearly as integrated or effective at exchanging and using information as they hope they appear to be. AHQR’s educational service has provided grants to four states (funding 16 states working in partnership) that offer statewide assistance to help clinicians and practices change in areas such as data management, adoption of VHRs, etc. There is a convergence opportunity for NCVHS Subcommittees to support a generic assistance organization. Change in healthcare must become a way of life. Classifications change continually. If you do not know “who’s who in the zoo”, you do not know how to manage indices and support query-based exchanges of clinical information for patient outcomes.

Letter of Agreement to Secretary of HHS

Subcommittee leadership will convene a conference call after compiling themes, observations and recommendations in order to produce a formal letter to the full Committee by September 2013.

In addition, a one-page letter was reviewed by the Subcommittee supporting NCPDP’s modification to the pharmacy claims transaction for capturing the actual quantity prescribed by providers (known as field code 460-ET), not currently in use. Because the National Committee recommends adoption and modification of standards, HHS expects a letter confirming a need for the change. The concern had been raised by the Office of the Inspector General in September 2012. The recommendation was to change from non-use to conditional use, allowing for information gathering that could be used to validate whether there were inappropriate fields in excess of quantities prescribed. A change to the transaction standard was approved by CMS in March 2013. The NCPDP recommendation and action plan included republishing the telecommunication standard implementation guide with an explanation of the change. The Subcommittee on Standards letter agreed with the recommended correction, which will be brought forward as part of the DSMO report. A copy of the letter will be distributed to Subcommittee members for further discussion.

Examine Industry Feedback on Attachment Letter sent (July 2013)

A draft letter of recommendations on attachments (published on the NCVHS website) will be reviewed at the full Committee meeting. Industry feedback to the letter’s 18 recommendations was reviewed. Editorial changes were made to the letter and content changes were suggested. The Subcommittee letter recommends adoption of the standards for attachments as well as a transitional process. Start date for doing claims attachments would be January 1, 2016 with prior authorization attachments coming later. NPRM is recommended. The original letter will be presented to the full Committee for discussion. A “red-line edit” with editing suggestions and additional clarifying changes (e.g., to recommendations 6, 10, 11, 12 and 18) will be incorporated into one modified document after input from the full Committee has also been obtained (prior to HHS submission).

Dr. Suarez recommended that publishing documents a week in advance to give the industry and others a chance to review and provide feedback become standard operating procedure for the Subcommittee on Standards.

Subcommittee Letter about Use of the Uniform Device Identifier in the Healthcare Claim

A process is underway to consider required use and EHR documentation of the UDI for inclusion in Meaningful Use, Stage Three (primarily for Class One implantable devices), the complexities of which were discussed. This would be useful for post-marketing surveillance, identifying potential issues with the devices and communicating with patients. Including the UDI in the next version of the healthcare claim and the transactions was recommended by the Pew Charitable Trust and the Brookings Institution. A letter was sent to the Subcommittee but no action is to be taken at this time.

Public Comment II

Ms. Hyland from the SSI group, representing HBMA, requested further consideration of end-to-end testing, citing challenges to commercial payers as well as to CMS. Providers must update their internal systems for ICD-10, which poses a range of complex difficulties, different definitions of end-to-end testing and delays. In addition, payer systems and CMS will not allow a complete end-to-end testing process. Even creating an 835 remittance advice in a production environment is limited. Moving forward, there is capability to create business-type testing models for providers, trading partners and associated products and services. Not everyone has to test. There will not be an actual limitation on providers who do not convert to 5010 because their trading partners have that capability; and alternatives to small providers needing to invest over $200,000 to update their systems exist. A recommendation was made to embrace new types of testing.

Adjournment, Day Two4:24 p.m.

To the best of my knowledge, the foregoing summary of minutes is accurate and complete.


Walter G. Suarez, M.D., M.P.H.


W. Ob Soonthornsima

DATE: July 20, 2013