Disclaimer: As noted below, this is a discussion paper, offering a few topics and potential solutions to think about while you evaluate your own comments to the NPRM. Several members of the HL7 Attachments committee worked with Jim Leach to compose this paper; however, it may not represent the opinions of everyone in the committee. At this time, we have not seen, nor have any “inside” knowledge of the NPRM itself. – mike cassidy 9-22-2005

Notice of Proposed Rule Making (NPRM) for Claims Attachments

May 5, 2005, revised September 21, 2005

Background: Over the past several years, representatives from CMS have made comments to the ASIG that suggest that each individual attachment specification may be proposed as a “Named HIPAA Standard” in the claims attachment NPRM. Since the HIPAA mandated implementation of transactions and code sets, the government, industry, and the Standards Development Organizations have gained new insights into the implications associated with naming specific versions and releases of implementation specifications as standards. During the recent HL7 plenary meeting, Dr. Brailer stressed the need for interoperability and flexibility of standards; standards that supports patients. Also that standards need to be responsive, not government standards, as government moves too slow.

There are advantages and disadvantages to having individual attachment specifications as a “Named HIPAA Standard” for the health care industry. The ASIG has not formally addressed this issue. This paper is for discussion purposes within the ASIG.

Advantages if individual attachment specifications are named HIPAA standards:

  1. As mandated standards, a level of stability would be introduced, such that implementers could rely upon long periods of time without a change in standards.
  2. New attachments and changes to existing attachments would receive broad opportunity for public scrutiny and comment as they move through the DSMO process, a federal Notice of Proposed Rule Making (NPRM), and a Final Rule.

Disadvantages if individual attachment specifications are named HIPAA standards:

  1. The process for changing existing attachments and adding new ones will be complicated and slow, requiring several years before approval and mandated implementation.
  2. Some attachments named under HIPAA may not be able to support user needs due to untimely updates and changes. CDA is an example of how the process can hinder progress. When the ASIG determined that the individual attachment specifications should be changed to CDA, CDA R1 was the only option available. Now, just a short time later, CDA R2 is the industry norm, and the NPRM will be citing CDA R1 attachment specifications. Situations such as this are likely to be even more prevalent in the future.
  3. Early adoption could be stifled, as some implementers might not perceive the value of their efforts.

Advantages of not having individual attachments as named HIPAA standards:

  1. The HL7 Implementation guide would be a named standard; the individual attachments would be addressed as belonging to an external code set owned and maintained by HL7.
  2. Changes to existing attachments and the promulgation of new attachments would be controlled by HL7. As an ANSI accredited SDO, input by interested individuals is permitted.
  3. The process would be shortened considerably, thereby enhancing responsiveness and would better support the use of electronic transactions by the health care industry.

Disadvantages of not having individual attachments as named HIPAA standards:

  1. Less opportunity for input by the general public, although it is unlikely that comments from the general public would be in regard to the technical content of the emerging attachment specifications.

Summary:

The ASIG has not taken a position on this issue. It has been discussed briefly, and in response to requests from individual members, the following draft response was developed as a guideline for anyone wishing to submit a dissenting comment in the event the NPRM does in fact propose making individual attachments a “Named HIPAA Standard”. While the text will need to be modified based upon the actual wording of the NPRM, it is a starting point for future discussion.

Possible comment:

Section ____, Paragraph______, of the NPRM, proposes that individual attachment specifications will be named as HIPAA standards. Individual attachment specifications are a small but important part of the health care claim for payment process. Naming individual attachment specifications as HIPAA standards adds unnecessary complexity and cost as well as delays to the administrative process, and is inconsistent with the intended goals of reducing health care costs through administrative simplification.

Individual attachment specifications must have the flexibility to change in response to industry changes and changing health care needs. The mandated process for changing existing standards and adopting additional standards is a very deliberate and slow process that while insuring rigid standardization and long-term stability, is not appropriate to the rapid changes in health care information or the processes and procedures for conveying such data electronically.

It is recommended that individual attachment specifications be characterized as an external code set that is owned and maintained by Health Level Seven (HL7), an American National Standards Institute (ANSI) accredited standards developer. Under ANSI guidelines, accredited standards developers must allow open participation and establish standards by consensus. Thus individual attachment specifications would represent the results of a consensus-based process derived from input and deliberation by health care industry and provider representatives as well as those interested individuals (private citizens) who chose to participate.