[Federal Register Volume 75, Number 197 (Wednesday, October 13, 2010)]
[Rules and Regulations]
[Pages 62684-62686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-25684]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

45 CFR Part 162

[CMS-0009-N]
RIN 0938-AM50


Health Insurance Reform; Announcement of Maintenance Changes to 
Electronic Data Transaction Standards Adopted Under the Health 
Insurance Portability and Accountability Act of 1996

AGENCY: Office of the Secretary, HHS.

ACTION: Notification.

-----------------------------------------------------------------------

SUMMARY: This document announces maintenance changes to some of the 
Health Insurance Portability and Accountability Act of 1996 standards 
made by the Designated Standard Maintenance Organizations. The 
maintenance changes are non-substantive changes to correct minor 
errors, such as typographical errors, or to provide clarifications of 
the standards adopted in our regulations entitled ``Health Insurance 
Reform; Modifications to the Health Insurance Portability and 
Accountability Act (HIPAA) Electronic Transaction Standards,'' 
published in the Federal Register on January 16, 2009. This document 
also instructs interested persons on how to obtain the corrections.

FOR FURTHER INFORMATION CONTACT:
Denise Buenning, (410) 786-6711
Gladys Wheeler, (410) 786-0273

SUPPLEMENTARY INFORMATION:

I. Background

    The Health Insurance Portability and Accountability Act of 1996 
(HIPAA) mandated the adoption of standards for electronically 
conducting certain health care administrative transactions between 
certain entities. Through subtitle F of title II of HIPAA, the Congress 
added to title XI of the Social Security Act (the Act) a new Part C, 
entitled ``Administrative Simplification.'' Part C of title XI of the 
Act consists of sections 1171 through 1180. These sections define 
various terms and impose several requirements on the Department of 
Health & Human Services (HHS), health plans, health care 
clearinghouses, and certain health care providers concerning the 
electronic transmission of health information.
    On August 17, 2000, we published a final rule in the Federal 
Register (65 FR 50312) entitled ``Health Insurance Reform: Standards 
for Electronic Transactions'' (hereinafter referred to as the 
Transactions and Code Sets rule). That rule implemented some of the 
HIPAA Administrative Simplification requirements by adopting standards 
developed by standard setting organizations (SSOs) for eight electronic 
transactions, and code sets to be used in those transactions. The SSOs 
are organizations that are accredited by the American National 
Standards Institute (ANSI), and that develop industry standards for, 
among others, the HIPAA transactions. We adopted standards developed by 
the Accredited Standards Committee X12 (hereinafter referred to as ASC 
X12) and the National Council for Prescription Drug Programs (NCPDP). 
We defined those transactions and specified the adopted standards at 45 
CFR part 162, subparts I and K through R. Designated Standard 
Maintenance Organizations (DSMOs) receive, manage, and process 
requested changes to the adopted standards in accordance with the 
process identified in the HIPAA regulations at Sec.  162.900. A 
description of the DSMO process can be found in the May 31, 2002 
proposed rule (67 FR 38050). Both ASC X12 and NCPDP are DSMOs.
    On August 22, 2008, we published a proposed rule in the Federal 
Register (73 FR 49742) entitled ``Health Insurance Reform: 
Modifications to Electronic Data Transactions Standards and Code Sets'' 
(hereinafter referred to as the Modifications proposed rule) proposing 
to modify the HIPAA transaction standards by adopting updated versions 
of the standards. On January 16, 2009, we published a final rule in the 
Federal Register (74 FR 3296) entitled Health Insurance Reform; 
Modifications to the Health Insurance Portability and Accountability 
Act (HIPAA) Electronic Transaction Standards (hereinafter referred to 
as the Modifications final rule), that adopted updated versions of the 
standards for

[[Page 62685]]

the electronic transactions originally adopted under HIPAA. We refer 
readers to the regulations cited above for a detailed discussion of the 
standards for electronic transactions and information about electronic 
data interchange, the statutory background, and the regulatory history.
    In the Transactions and Code Sets rule, we defined the terms 
``modification'' and ``maintenance of standards.'' We explained that, 
when a change is substantial enough to justify publication of a new 
version of an implementation specification, such change is considered a 
modification, and must be adopted by the Secretary through regulation 
(65 FR 50322). Maintenance, on the other hand, describes the activities 
necessary to support the use of a standard, including technical 
corrections to an implementation specification. Maintenance changes are 
typically changes that are obvious to readers of the implementation 
guides, are not controversial, and are essential to implementation (68 
FR 8388, (February 20, 2003)). We note that regulatory action is not 
required to make maintenance type changes to the HIPAA adopted 
standards (65 FR 50322).

II. Provisions of the Notification

A. ASC X12 Version 5010 HIPAA Transaction Standards

    We adopted ASC X12 standards for the following eight HIPAA 
administrative transactions: (1) Health care claims or equivalent 
encounter information; (2) health care payment and remittance advice; 
(3) coordination of benefits; (4) eligibility for a health plan; (5) 
health care claim status; (6) enrollment and disenrollment in a health 
plan; (7) referral certification and authorization; and (8) health plan 
premium payments. In the January 16, 2009 Modifications final rule, we 
adopted the ASC X12 Technical Reports Type 3, Version 005010 
(hereinafter referred to as Version 5010) to replace the currently 
adopted Version 4010/4010A1 standard for the eight HIPAA transactions 
(74 FR 3296).
1. Errata Notification
    Following publication of the Modifications final rule, ASC X12 
notified HHS that they were receiving feedback from the industry 
regarding errors that had been overlooked during ASC X12 standards 
review process. These errors were not identified in the comments 
submitted during the public comment period for the Modifications 
proposed rule, and therefore are not reflected in the Version 5010 
standards adopted in the Modifications final rule.
    After the industry reported these errors, ASC X12 compiled a 
summary and in February 2010 as required under the DSMO process, 
initiated consultations with HHS and the National Committee on Vital 
and Health Statistics (NCVHS), an advisory body to HHS on health data, 
statistics and national health information policy. (For a complete 
discussion of this NCVHS process, we refer readers to the August 22, 
2008 proposed rule (73 FR 49742). ASC X12 then balloted and completed 
approval for these changes to the Version 5010 standards in accordance 
with the established ASC X12 approval process, in July 2010.
2. Errata Classification
    ASC X12 issued errata to Version 5010 in July 2010. It has 
categorized the errata as both Type 1 and Type 2. These errata 
constitute maintenance changes under the HIPAA regulations, not 
modifications. The ASC X12 defines errata as: (1) Publication variances 
from approved X12 Committee actions (publication errors); or (2) 
editorial corrections such as spelling, punctuation, spelling out 
abbreviations or acronyms.
    ASC X12 further defines Type 1 and Type 2 errata as follows:
    <bullet> Type 1 Errata change the constraints of the base standard, 
but do not change the base standard itself. The sender and receiver 
must implement the Type I Errata in order to conduct a successful 
interchange.
    <bullet> Type 2 Errata supplement a published Technical Report Type 
3 (TR3) with minor changes that clarify or correct the TR3 Report. 
Implementation Guide constraints are not changed, and the sender and 
the receiver do not have to implement the errata to conduct a 
successful interchange.
    Neither Type 1 or Type 2 Errata can change the underlying base ASC 
X12 transaction standard or associated internal code sets (http://www.x12.org/newsletters/tr/index.cfm).
3. Errata Distribution
    The errors that were identified by the industry, and ASC X12's 
balloted and approved response that was completed July 2010, are 
contained in the errata posted to the ASC X12 Web site, at http://www.x12.org, and are available free of charge for purchasers of Version 
5010. In the interest of broad stakeholder outreach, CMS also posted a 
link for the ASC X12 errata to its Web site, at http://cms.gov/ICD10.

B. NCPDP Telecommunication Standard D.0

    We adopted NCPDP standards for the following retail pharmacy drug 
transactions: Health care claims or equivalent encounter information; 
eligibility for a health plan; referral certification and 
authorization, coordination of benefits; and Medicaid pharmacy 
subrogation. In the Modifications final rule, we adopted the NCPDP 
Telecommunications Standard Implementation Guide, Version D, Release 0 
(Version D.0) and equivalent NCPDP Batch Standard Implementation Guide, 
Version 1, Release 2 (Version 1.2) in place of the NCPDP 
Telecommunication Standard Implementation Guide, Version 5, Release 1 
(Version 5.1) and equivalent NCPDP Batch Standard Implementation Guide, 
Version 1, Release 1 (Version 1.1), for the HIPAA retail pharmacy drug 
transactions.
1. Change Notification
    Following publication of the Modifications final rule, NCPDP and 
industry stakeholders notified HHS that corrections were needed for 
errors in Version D.0 that had been either unintended mistakes or 
overlooked during the NCPDP standards review process. Those errors were 
not identified in the comments submitted during the public comment 
period for the Modifications proposed rule, and therefore are not 
reflected in the standards adopted in the Modifications final rule.
    After the industry reported these errors, NCPDP compiled a summary 
of the needed corrections and their proposed remedies, and in April 
2010 initiated consultations with HHS and the NCVHS. NCPDP balloted the 
changes and approved them, in accordance with the established NCPDP 
approval process, in August 2010. Each of the error corrections to 
Version D.0 are maintenance changes, as that term is defined under the 
HIPAA regulations.
2. NCPDP Change Distribution
    The errors that were identified by the industry, and NCPDP's 
balloted and approved response that was completed in August 2010, are 
contained in the August 2010 publication of NCPDP Editorial Document 
posted to the NCPDP Web site, at http://www.ncpdp.org. The publication 
of the changes is available free of charge for purchasers of Version 
D.0. In the interest of broad stakeholder outreach, CMS also posted a 
link for the NCPDP August 2010 Editorial Document to its Web site, at 
http://cms.gov/ICD10.

[[Page 62686]]

    It is important that HIPAA covered entities, vendors, and third 
party billers obtain the ASC X12 Version 5010 and the NCPDP Version D.0 
error corrections and include them in their implementation of Version 
5010 and Version D.0 standards. It should be noted that the HIPAA 
compliant versions include the error corrections. The Version 5010 and 
Version D.0 HIPAA compliant standards should be incorporated into 
systems as soon as possible. There is urgency for entities to do so 
quickly in light of the HHS-specified Version 5010 and Version D.0 
January 1, 2011 testing date and the January 2012 implementation date. 
In addition, adhering to these time frames is critical for meeting the 
requirements to implement Version 5010 and Version D.0 prior to the 
October 2013 implementation date for the ICD-10 code set.
    The ASC X12 Standards for Electronic Data Interchange Technical 
Report Type 3 and Errata may be obtained from the ASC X12, 7600 
Leesburg Pike, Suite 430, Falls Church, VA 22043; Telephone (703) 970-
4480; Fax: (703) 970 4488. They also are available through the Internet 
at http://www.X12.org.
    The implementation specifications and the NCPDP D.0 Editorial 
Document may be obtained from the National Council for Prescription 
Drug programs, 9240 East Raintree Drive, Scottsdale, AZ 85260; 
Telephone (480) 477-1000; Fax: (480) 767-1042. They are also available 
through the Internet at http://www.ncpdp.org.

III. Collection of Information Requirements

    This document does not impose information collection and 
recordkeeping requirements. Consequently, it need not be reviewed by 
the Office of Management and Budget under the authority of the 
Paperwork Reduction Act of 1995.

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical 
Assistance Program; No. 93.773 Medicare--Hospital Insurance Program; 
and No. 93.774, Medicare--Supplementary Medical Insurance Program)


    Approved: October 6, 2010.
Kathleen Sebelius,
Secretary.
[FR Doc. 2010-25684 Filed 10-8-10; 11:15 am]
BILLING CODE 4150-29-P