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Summary: Modifications to Standards for Electronic
Transactions and Code Sets

By Amanda Dorsey, Director, Phoenix Health Systems
February 2003

On February 13, 2003, HHS Secretary Tommy Thompson announced the adoption of Modifications to Standards for Electronic Transactions and Code Sets, a HIPAA regulatory update that was published in the Federal Register on February 20, 2003. The modifications represent the latest in a series of federal electronic data interchange standards that address a central objective of HIPAA -- healthcare administrative simplification. The timeline below offers a recap of the progress of these regulatory developments, beginning with their inception in 1998.


TCS Timeline to Date:

  • May 7, 1998 -- Proposed rule for Standards for Electronic Transactions and Code Sets (TCS) was published in the Federal Register.

  • August 17, 2000 -- Final rule for Standards for Electronic Transactions and Code Sets was issued by the Secretary of HHS. The rule provided for national standardization of the most common healthcare transactions and several code sets. The compliance deadline was set for October, 2002.

  • January 3, 2001 -- The Administrative Simplification Compliance Act (ASCA) was passed by Congress, providing for an extension of the TCS compliance deadline until October 16, 2003 for covered entities that filed a compliance plan with CMS by October 16, 2002.

  • May 31, 2002 -- Two proposed rules, CMS-0003-P and CMS 0005-P, were published in the Federal Register. The two proposed rules recommended that CMS adopt modifications to certain transaction standards.

    More specifically, CMS-0003-P proposed modifications to the current electronic data interchange (EDI) standards for retail pharmacy transactions. It also proposed a repeal of the designation of National Drug Codes (NDCs) as the standard medical data code set for reporting drugs and biologics on non-retail pharmacy standard transactions. CMS-0005-P addressed technical changes to certain implementation specifications for the transaction standards. Because of numerous inconsistencies and unanswered questions, implementation of industry-wide EDI standards would have been frustrating at best, without incorporation of many of the suggested changes.

  • February 13, 2003 -- HHS Secretary Tommy Thompson announces final rule on CMS-0003 and CMS-0005.

The TCS Modifications

CMS received over 300 public comments in response to the May 31, 2002 publication of the proposed modifications. The comments came from a variety of sources, including healthcare associations and societies, health plans, Designated Standards Maintenance Organizations (DSMOs), healthcare providers, Federal health plans, and private individuals. In the proposed rule, groups that define content of the transactions (called Data Content Committees or DCCs) collaborated with Standards Development Organizations (SDOs) to determine the global business need and the appropriate model, structure and syntax for each transaction. Both groups (SDOs and DCCs) allowed comments from the public at any time via their web sites in order to foster an environment of open participation and discussion.

So what's new in the February 13th final rule? Readers who are involved in their organization's implementation of the EDI standards or inpatient/outpatient billing processes may find the content of the final rule somewhat familiar since most of the final rule is what was already proposed in the May 31, 2002 draft rule. For those covered entities that have already begun testing the standard EDI transactions with their payers, the following bullets list some of the adopted changes that may affect your department:

  • The National Drug Code (NDC) was repealed as the standard medical data code set for reporting drugs and biologics in all non-retail (i.e., institutional and professional) pharmacy transactions.

  • The proposed addenda to the WPC Implementation guides were adopted after extensive discussions with DSMOs. These addenda proposed very detailed recommendations at the data-element level and are meant to "fill in the blanks" left in some of the implementation guides.

  • For retail pharmacy transactions:

    • The National Council for Prescription Drug Programs (NCPDP) Batch Version 1.1 was adopted to support the Telecommunications Version 5.1.

    • The Accredited Standards Committee (ASC) X12N 835 was adopted as the standard for payment and remittance advice, and the NCPDP Telecommunications Version 5.1 and NCPDP Batch Version 1.1 Implementation Guides as the standard for the referral certification and authorization transaction.

    • The NDC code set will continue to be used for the reporting of drugs and biologics.

  • Two modified standards (premium payments and coordination of benefits) that were not included in the proposed rules were adopted. The modifications provide explanatory guidance.

  • The effective date of the final rule is 30 days after the Federal Register publication date of February 20, 2003 -- or March 22, 2003. Covered entities that have submitted timely compliance plans (in accordance with ASCA) must be in compliance with the TCS Rule, as amended by the modifications, no later than October 16, 2003. (Small health plans are provided an additional year for compliance.)

The Bottom Line

In general, the final modifications did not contain any unexpected or surprising changes, for which most HIPAA-watchers will be grateful. The new rule did, however, include some significant commentary on the issue of deadlines for testing and implementing the standard transactions. CMS acknowledged that the modifications adopted as a result of CMS-0003-P and CMS-0005-P are necessary for transactions to be conducted in standard form. CMS also acknowledged that its delay in finalizing the modifications has created a situation in which covered entities who did not apply for the ASCA extension could not possibly have complied with the TCS standards by the original compliance date of October 16, 2002. Consequently, CMS stated that it "will not invoke [its] authority to penalize noncompliance with standards that [its] own delay…has made infeasible."

Further, CMS announced two related decisions. It is affording covered entities who are already obliged to comply with the TCS standards (those who did not apply for the ASCA extension) the opportunity to comply with either the unmodified transaction standards or the modified standards during this interim one-year extension period. And, CMS will "take into account the numerous obstacles" and will work with covered entities through corrective action plans, rather than penalize their noncompliance.

Finally, CMS noted that it believes that there is sufficient time between the publication date of the TCS modifications and the ASCA April 2003 testing deadline for covered entities to meet that deadline. Similarly, CMS has noted that there is sufficient time for covered entities to meet the October 16, 2003 compliance deadline provided under ASCA.

Regardless of your approach to compliance, it is critical that you contact all of your trading partners immediately for the purpose of addressing application of the TCS modifications, if you have not already done so. CMS is on the record in its position that the effort involved in implementing the adopted TCS modifications should not prevent any covered entity that makes a reasonable effort from achieving on-time compliance. The October 16, 2003 deadline still stands and CMS states very clearly that it has no jurisdiction to extend the compliance deadline again.

The process for arriving at this final rule speaks volumes to the value of industry collaboration and open communication; and perhaps even more so to the role standards can and will play in our industry in the coming years. By allowing cross-industry input from large corporations, professional organizations and individuals, the healthcare industry is now much better positioned to take advantage of the opportunities presented by EDI.

Read the final rule.


Amanda Dorsey, Director, Phoenix Health Systems, delivers HIPAA consulting solutions to hospital clients and physician practices. Phoenix is expert in HIPAA change management, strategic planning, and procurement, implementation and integration of state-of-the-art healthcare information technology. www.phoenixhealth.com

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