X12 Comments on CMS NPRM regarding Attachments

Thank you for the opportunity to provide comments related to the adoption of standards for health care attachment transactions and electronic signatures, and modification to referral certification and authorization transaction standards (45 CFR Parts 160 and 162). We support the rule and appreciate CMS’ diligence in its development.

X12 has operated as an ANSI-accredited standards developer (ASD), sometimes referred to as a standards development organization (SDO), for more than 40 years. As a consensus-based ASD, we focus on the development, implementation, and ongoing use of interoperable electronic data interchange standards that drive business processes. X12 is supported by a strong and diverse membership that includes business leaders, process experts, and technologists, encompassing health care, insurance, transportation, finance, government, supply chain, and other industries.

X12 standards are the workhorse of business-to-business exchanges, proven by the billions of transactions based on X12 standards that are used daily in various industries including supply chain, transportation, government, finance, and health care. Millions of entities around the world have an established infrastructure that supports X12 transactions.

As you are aware, most of the administrative transactions adopted under the Health Insurance Portability and Accountability Act (HIPAA) and related legislation and regulations were developed and are maintained by X12. In addition, X12 has a robust set of transactions and code sets beyond those already adopted that are being used voluntarily within the health care industry. X12 and its member representatives work closely with federal and state agencies, other SDOs, and health care industry groups to ensure the needs of the stakeholders are met consistently and seamlessly across the industry. X12 is committed to continuing our tradition of reducing administrative burden and increasing consistency in information exchanges while ensuring the data stakeholders need is available when they need it, in a format compatible with their technical infrastructure.

X12’s comments on this rule were informed by input from our member representatives and responses to a survey that was open to X12 member representatives and the public. Based on the survey:

• 78% of the respondents indicated support for advancing the mandated transactions to the most current version.
• 66% indicated they were aware of new or enhanced functionality in the most current version that will benefit their organization.
• 56% of the respondents noted that their organization would benefit from a mandate for claim/encounter attachments.
• 56% also indicated their organization would benefit from a mandate for health care services review attachments.

X12 supports the intent of this rule and its details. Because industry stakeholders have been vocal about the need for this attachment functionality, we encourage CMS to move forward expeditiously so that implementers can realize the value of this functionality as soon as possible.

We do have a few overall comments for consideration.

• Moving this rule forward is certainly progress for health care industry stakeholders and X12 will provide support to CMS, industry stakeholders, and other SDOs as needed to ensure a smooth rollout of the new and updated transactions. However, X12 encourages CMS to consider that much of the industry discussion about barriers to authorization implementation is related to the internal policies and processes of each trading partner, not to the exchange of information between them. To some extent, X12 believes that implementing attachments may run into similar barriers so some consideration of those factors may be wise.
• Anecdotally, X12 is hearing from many implementers that they will not begin to assess and plan for implementing the functionality described in this rule until after the Final Rule is issued. Based on that input, X12 encourages CMS to consider whether they can give date-certain information for some or all the remaining stages of the rulemaking process.  

Finally, X12 would like to emphasize a few high-level points. One, there is a significant amount of overlap in the various RFIs, NPRMs, and Rules being issued on the federal side. X12 is concerned that stakeholders will be subject to conflicting mandates if we don’t work together to find a method to organize and integrate the disparate requirements. Two, many health care stakeholders submitted clear statements to NCVHS that having to support two, or possibly more, syntaxes and/or versions is a step backward from the standardization we’ve achieved under HIPAA. These concerns deserve an open-minded, frank discussion between federal representatives and industry stakeholders. We don’t want to undo decades of EDI success by making significant and costly changes just for the sake of changing. Three, to repeat X12’s drumbeat mantra, interoperability between syntaxes may be good for the industry but it cannot succeed unless the data is standardized. If the data is standardized, implementers that have invested millions of dollars into stable and mature EDI systems can continue to accrue value on those sunk costs by adding functionality and enhancements to the existing infrastructure and other implementers may make another choice. Historically, HL7 has been the definitive source for clinical data standards and X12 has been the definitive source for administrative data standards, if we harmonize the overlap, the health care industry will have a solid base to build on with little or no inconsistencies in the overlap.

Our detailed comments are included below. Please contact me at csheppard@x12.org  if you need more information or have any questions about the comments.

Sincerely,

Cathy Sheppard, X12 CEO

cc: Stephanie Fetzer, X12 Board Chair
      Gary Beatty, Accredited Standards Committee Chair

Detailed Comments

• X12 has put forward recommendations related to currently mandated transactions that request the most current version of implementation guides be used in the Final Rule. We have committed to providing detailed revision information if revisions have been applied between the NPRM version and the Final Rule version. We request that NSG consider using that same approach with the rule. If that methodology can’t be accommodated, X12 will submit a recommendation to advance the versions of the transactions included in this NPRM after this Final Rule is released.
• X12 has some concerns about implementation guide version requirements in various rule-making processes and would like to work with NSG to produce some clarifying informational materials for industry stakeholders as part of the NSG review of these comments. 
• X12 recommends that the proposal to replace the current payload options be modified to support all those options and the new C-CDA option. Several organizations are voluntarily exchanging attachments successfully today using the current options, forcing them to abandon their mature and effective solutions and incur costs to move to a different solution without any corresponding functional gain is likely to have a severe negative impact on voluntary implementations in the future.
• X12 recommends supporting LOINC as the code/value set to reflect the type of information being sent or requested.
• We recommend you reconsider the signature requirements such that an electronic signature is only required when the payer or a CDA template requires a signature. This is less disruptive to trading partners who are already successfully exchanging attachment information.
• X12 supports control standards equivalent to the proposed electronic signature option. We request that you consider allowing that protocol so that trading partners currently exchanging attachments successfully via X12 implementations can meet the signature requirements in the same syntax they are already using.
• Although X12 supports “willing trading partner” scenarios in general, in the past these agreements were often implemented in more of an “800-pound gorilla says “trading partner, you better be willing or you can’t be in my network” way. If a “willing partner” option is to be permitted, we recommend establishing some structure or guidance to reduce or eliminate the possibility of coercion. 
• Related to possibly adding CDex as an alternative attachment standard, it is X12’s understanding that CDex 2.0 was recently published with the attachments transactions listed as draft content and as a standard for trial use, not as a normative standard. We do not believe draft implementation guides should be included in NPRMs or Final Rules. Perhaps this can be reconsidered at a later date.