NCVHS Response Letter

1405 S Fern St #92957 ● Arlington VA 22202 ● Phone (703) 970-4480 ● Fax (703) 970-4488 ● X12.org

July 31, 2023

Jacki Monson, JD
Chair, National Committee on Vital and Health Statistics
c/o Rebecca Hines
NCVHS Executive Secretary
3311 Toledo Road
Hyattsville, MD 20782

Dear Ms. Monson,

This response is related to the letter you sent to Secretary Becerra on behalf of the National Committee on Vital and Health Statistics (NCVHS) on June 14, 2023. The NCVHS letter relates to X12’s recommendation for moving updated versions of the X12 standards for Claims and Electronic Remittance Advice transactions through the Federal Rulemaking process. The recommended implementation guides include the following.

• 008020X323 Health Care Claim: Professional (837)
• 008020X324 Health Care Claim: Institutional (837)
• 008020X325 Health Care Claim: Dental (837)
• 008020X322 Health Care Claim Payment/Advice (835)

X12 appreciates the opportunity to provide feedback on the NCVHS recommendation that HHS not move forward with rulemaking related to advancing the version on the claim and remittance advice standards. In the letter the NCVHS cites three concerns related to their decision not to recommend the standards mandated under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) be updated to a more current version. X12 disagrees with the NCVHS conclusions and asks that the NCVHS reconsider the recommendation.

The first reason relates to the NCVHS concerns that having some transactions mandated based on X12’s 005010 version and others mandated on later versions would introduce unknown compatibility issues and potentially cause disruption across industry trading partners. The NCVHS also cites a need for evidence of backward compatibility.

Based on review of some of the written comments and discussion at the NCVHS’ hearing on the X12 recommendations, we want to clarify that we are not recommending the industry support multiple versions of the same transaction beyond the transition period named in a Final Rule.

X12 holds that the NCVHS concern related to the exchange of different versions of the same X12 transaction sets is unsupported at this time. Health care industry trading partners already regularly exchange messages based on different versions of X12 standards. Examples include the exchange of 005010 claims and 006020 attachments, and the exchange of acknowledgement transactions based on a different version than the EDI message being acknowledged. In addition, during the transition to the 004010 mandated versions, trading partners supported many versions of each transaction. Similarly, during the transition from 004010 to 005010, most trading partners supported both versions.

The statement that evidence of “backward compatibility” is needed seems to indicate some misunderstanding of what X12 has proposed and how electronic data interchange (EDI) standards advance version to version. The benefits of moving to a new version are negated by a requirement that nothing can be introduced or revised that wasn’t already supported in the prior version. Indeed, not advancing the version of mandated standards as business practices evolve will continue to cause disruption because trading partners cannot use a newer version of a standard to communicate data that supports emerging industry requirements.

X12 believes it is more appropriate for Federal agencies and their advisors to focus on cross-compatibility rather than “backward compatibility”. Cross-compatibility in this context is achieved when separate transactions in different versions interact smoothly and effectively. X12’s development processes, both the change request CR process in place for versions 007010 and prior and the maintenance request (MR) process in place now, include an explicit step for verifying that information can flow smoothly through the health care transaction workflows. Since humans are involved, there may be some things missed, but X12 has processes in place for such an eventuality. It is likely that some best practice instructions guiding the industry to such seamless interactions will be necessary, as they have been in the past when newer versions of mandated standards were implemented. As an example, one of the comments presented to the NCVHS noted a concern about the number of modifiers supported in current mandated versions when compared to the increased number of modifiers in the recommended transactions. Instructions related to how differences in the number of modifiers should be handled can either be published as Request for Information (RFI) instructions or, as X12 recommended, in a later version named in the Notice for Proposed Rulemaking (NPRM). The organizations participating in X12’s pilot are testing to identify whether additional guidance is necessary or helpful during the transition period when some trading partners have moved to a later version and others are still in the transition process.

X12 further notes that the decision to submit its recommendations in sets was based in part on the NCVHS’ recommendations that the health care industry is better served by more frequent updates with fewer revisions in each update and in part on industry feedback that health care trading partners are currently working to implement technology solutions to satisfy several federal health care requirements simultaneously so smaller sets of revisions are more manageable.

The second reason cited by the NCVHS relates to “sufficient” information about cost, value, use cases, burden, opportunity, and efficiency. X12 included a list of functional enhancements and potential benefits that support business requirements as submitted by implementers in its recommendation to the NCVHS and we will provide additional details to inform the NCVHS reconsideration on the matter separately. In addition, as X12 noted to the NCVHS in their recommendation letter and in subsequent discussions, we included the high-level cost estimates so that the National Standards Group (NSG) of the Office of Burden Reduction & Health Informatics (OBRHI) within the Centers for Medicare & Medicaid Services (CMS) division of Health and Human Services (HHS) would have a general basis for the cost/benefit information they must generate as part of the Federal Rulemaking process.

As has been true for standards upgrades historically, it is difficult to provide detailed or verifiable cost and resource impacts in advance of actual implementations. In the current environment, where Federal Rulemaking can take an extended period of time with implementation deadlines following Final Rules by several years, there are few organizations willing to invest time and resources implementing new versions or new standards in advance of a mandate or at least a strong recommendation for a new mandate. This makes it difficult for standards developers to provide supporting information generated based on real-world experiences.

While a full cost-benefit analysis would be the ideal situation, most organizations will not undertake this task until at least an NPRM is published, and others won’t do so until a final rule is published. The NCVHS has noted in past recommendations to the HHS Secretary that a timelier federal process should be considered, and this recommendation includes a statement that the long lead-time for regulatory processes needs to be addressed. HHS has not implemented changes or committed to considering such changes to the Rulemaking process based on the previous suggestions and it is doubtful it will do so based on this letter. Since changes to improve the federal process would take years to develop, approve, and implement and don’t appear to be on the horizon, it is not reasonable to hold off on upgrades the industry has requested and needs in the hopes that a quicker Rulemaking process will be implemented. X12’s annual publication cycle ensures we can support the health care industry’s emerging needs on a timely basis, and we will work with the NCVHS and other Federal regulators to create the smoothest path for such updates going forward.

It’s important to note the commenting organizations did not provide supplemental cost data beyond that which X12 provided in its submission letter; in fact, several noted that real-world cost data would not be available from their organizations until after a related NPRM is published. Indeed, this reticence to incur costs early, without a firm assurance that a mandate is forthcoming, has even impacted the X12 pilot, with some participants considering suspending their testing efforts based on the NCVHS recommendation that HHS not adopt the transactions at this time. Commenters indicated that cost impacts would vary based on the size of the organization and whether they implement the changes internally or rely on the services of vendors or clearinghouses. It is X12’s position that the written comments and oral testimony, including that provided by the Workgroup for Electronic Data Interchange (WEDI) which is named in the legislation as an organization specifically responsible for advising the government representatives, provided clear evidence that the health care industry supports the implementation of more current versions of the mandated transactions. In addition, all the revisions approved for inclusion in the recommended versions were approved through our American National Standards Institute (ANSI) accredited consensus process.

From X12’s perspective, much of the information the NCVHS identifies in their letter to the Secretary as required by the NCVHS is more appropriately gathered from the impacted and materially interested health care EDI experts, both business and technical, who represent the health care industry implementers. Gathering feedback on benefits, concerns, implementation details, and other intangibles is one of the identified purposes of the (NPRM).

The third reason cited by the NCVHS concerns two upcoming business and technical requirements. The first, ICD-11, is still being studied by the Federal Government and materially interested parties. Some industry experts expect the earliest a phase-in could start is 2025 or 2027, depending on whether clinical modifications are needed. The Centers for Disease Control and Prevention (CDC) recently testified to the NCVHS that the ICD-11 code set for mortality statistics would be implemented in 2028, if all goes well. Since the use of ICD-11 for morbidity will be subject to HIPAA regulatory constraints, which the mortality uses are not, it is reasonable to expect that use of ICD-11 for morbidity will have an implementation date sometime after 2028. Based on previous experience with advancing the version of ICD in the United States, most expect the ICD-11 phase-in to be many years in the future. Indeed, the NCVHS itself is still conducting research and gathering information, with an expert roundtable meeting planned for August of this year. X12 has processes in place to accommodate ICD-11 in future versions of its standards once the business requirements are understood.

The second upcoming requirement referenced by the NCVHS is related to the National Drug Code (NDC). The Food and Drug Administration (FDA) has published a proposed rule to modify the format of the NDC but a Final Rule is still pending. Until that Final Rule is issued and corresponding implementation deadline(s) are established, specific revisions are speculative. Notably, as recently as July 12, 2023, National Council for Prescription Drug Programs (NCPDP) solicited industry feedback[1] on additional changes to the NDC format recognizing the impact to the industry isn’t fully understood. Certainly, implementation deadlines are likely to be several years after the Final Rule is published. X12 will act to accommodate the Final Rule’s requirements related to NDC formats as soon as possible after the Final Rule is released.

From both historical and reasonable perspectives, holding up forward progress on functionality needed by the health care industry now based on the expected release of unknown future requirements is not a wise approach. In the past, X12 has rarely approved inclusion of “when/if” instructions related to requirements that were expected to be included in rulemaking finalized after the X12 instructions were published. When the final rulemaking was different than expected, the "when/if" instructions ended up being a disservice to the industry. For example, X12 included implementation instructions for a national plan identifier (HPID and OEID) in the 005010 version as requested. But those instructions became problematic, causing confusion for implementers when the use of the national plan identifier was subsequently rescinded.[2]

As evidenced by the NCVHS’ interest in these pending industry enhancements, being able to adopt new versions of X12’s standards more quickly with reduced implementation costs is a significant benefit to moving to one of X12’s version 8 releases now. Once the industry moves from 005010, adopted in 2009, to a current version, X12 and its implementers will be able to advance necessary functionality much more nimbly.

In the letter to the Secretary, the NCVHS also notes concerns related to the use of virtual credit cards and the inclusion of Device Identification (DI) information. The NCVHS noted, and X12 concurs, that those issues are related to HHS policies rather than the X12 standards. We also concur with the NCVHS statement that the requirements in the 008020 versions of the recommended standards related[3] to the situational use of virtual credit card and device identification information were vetted and approved via our ANSI accredited consensus process. Regarding the DI information, the concerns presented to the NCVHS are not new and were discussed thoroughly as part of the X12 collaboration process. Several pilots have already tested the ability to capture the DI for claims, and the results showed inclusion of the DI information is possible, relatively easy, and not costly for hospitals. We also note that the FDA is already working with health care organizations to address the concern related to defining high risk devices.

As stated in the letter to the Secretary, the NCVHS is concerned about the long lead-time for regulatory processes. Though X12 shares the NCVHS’ concern about being able to accommodate emerging needs timely when the Federal regulatory process moves more slowly, that concern is far broader than any request to advance the version of a particular mandated standard. The timing issues are also likely to impact evolving requirements from the health care industry stakeholders as well as emerging federal requirements, such as recently updated requirements from the Office of Management and Budget (OMB), the No-Surprises Act, and potential ICD-11 usage requirements. We believe that the NCVHS’ concerns can be addressed during the period between the NCVHS recommendation to move forward with an NPRM and the publication of the related NPRM and that such a path balances the realities of the Federal Rulemaking timelines and the need to support the emerging requirements. Further, we believe that inclusion of a suggestion that the NPRM specifically request feedback related to the concerns identified in the original recommendation letter would be well-taken by federal regulators and the health care organizations that exchange the claim and remittance advice EDI transactions. If the NPRM includes an explicit call for comments on the areas of concern and input on whether a Final Rule should name the 008020 versions or a later version that addresses pending requirements, such as new formatting requirements for the NDC codes, and any challenges identified in the X12 pilot or by industry stakeholders, the impacted and materially interested experts, both business and technical, who represent the health care industry implementers will be able to comment based on their diligent analysis.

As such, and for the good of the industry, we respectfully request that the NCVHS reconsider their recommendation and support HHS moving forward with a modification to the current mandates for claim and remittance advice explicitly requesting comments on specific areas of concern or opportunity as noted above.

Sincerely,

Cathy Sheppard

Cathy Sheppard
X12 CEO

csheppard@x12.org

[1] The National Council for Prescription Drug Programs WG19 NDC Scarcity Task Group online survey regarding additional NDC changes

[2] https://www.cms.gov/Regulations-and-Guidance/Administrative-Simplification/Unique-Identifier/HPID

[3] https://pubmed.ncbi.nlm.nih.gov/33734207/