Administrative Simplification: Adoption of Standards for Health Care Attachments Transactions and Electronic Signatures, and Modification to Referral Certification and Authorization Transaction Standard
Proposed rule.
CFR Part: "45 CFR Parts 160 and 162"
RIN Number: "RIN 0938-AT38"
Citation: "87 FR 78438"
Document Number: "CMS-0053-P"
Page Number: "78438"
"Proposed Rules"
Agency: "
SUMMARY: This rule would implement requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, enacted on
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I. Executive Summary
A. Purpose
This rule proposes to adopt a set of standards for the electronic exchange of clinical and administrative data to support prior authorizations and health care claims adjudication. In determining the necessity of a health care service as part of making a coverage decision, health plans often require additional information that cannot adequately be conveyed in the specified fields or data elements of the adopted prior authorization request or health care claims transaction. If adopted as proposed, this proposed rule would support electronic transmissions of this type of information, which should have the effect of decreasing the use of time and resource-consuming manual processes such as mail or fax often used today to transmit this information. This would facilitate prior authorization decisions and claims processing, reduce burden on providers and plans, and result in more timely delivery of patient health care services.
a. Need for the Regulatory Action
This rule would adopt a set of standards for the electronic exchange of clinical and administrative data to support prior authorizations and claims adjudication. Despite widespread deployment of electronic health records (EHRs), and industry experience with Health Insurance Portability and Accountability Act of 1996 (HIPAA) standards that continues to advance since HIPAA's advent, transmitting health care attachments is still primarily a manual process and, at this time, there are no adopted HIPAA standards, implementation guides, or operating rules for health care attachments or electronic signatures. If adopted, this proposed rule would support electronic transmissions of this type of information rather than the use of manual processes such as mail and fax that still predominate in the health care industry.
We believe that the health care industry has long anticipated the adoption of a set of HIPAA standards for the electronic exchange of clinical and administrative data to support electronic health care transactions, such as prior authorization of services and claims adjudication, and the standards we are proposing to adopt are an important step in reducing provider burden.
B. Summary of the Major Provisions
This rule would implement requirements of the Administrative Simplification subtitle of HIPAA and the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, enacted on
C. Summary of Costs and Benefits
Based on industry research by the
II. Background
A.
This background discussion presents a history of statutory provisions and regulations that are relevant for the purposes of this proposed rule.
1. Standards Adoption and Modification Under the Administrative Simplification Provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA)
Section 1172(a) of the Act indicates that any standard adopted under HIPAA shall apply, in whole or in part, to the following persons, referred to as "covered entities": (1) a health plan; (2) a health care clearinghouse; and (3) a health care provider who transmits any health information in electronic form in connection with a [HIPAA transaction]. Generally, section 1172 of the Act indicates that any standard adopted under HIPAA is to be developed, adopted, or modified by a standard setting organization (SSO). In adopting a standard, the Secretary must rely upon recommendations of the
Section 1172(b) of the Act indicates that a standard adopted under HIPAA must be consistent with the objective of reducing the administrative costs of providing and paying for health care. The transaction standards adopted under HIPAA enable financial and administrative electronic data interchange (EDI) using a common structure, as opposed to the many varied, often proprietary, transaction formats on which industry had previously relied and that, due to lack of uniformity, engendered administrative burden. Section 1173(g)(1) of the Act, which was added by section 1104(b) of the Affordable Care Act, further addresses the goal of uniformity by requiring the Secretary to adopt a single set of operating rules for each transaction during the implementation of the electronic standards. These operating rules are required to be consensus-based and reflect the business rules that affect health plans and health care providers and the manner in which they operate.
Section 1173(a) of the Act indicates that the Secretary must adopt standards for financial and administrative transactions, and data elements for those transactions, to enable health information to be exchanged electronically. The original HIPAA provisions require the Secretary to adopt standards for the following transactions: health claims or equivalent encounter information; health claims attachments; enrollment and disenrollment in a health plan; eligibility for a health plan; health care payment and remittance advice; health plan premium payments; first report of injury; health claim status; and referral certification and authorization. The Affordable Care Act added the requirement that the Secretary adopt a standard for electronic funds transfers. Additionally, section 1173(a)(1)(B) of the Act requires the Secretary to adopt standards for any other financial and administrative transactions the Secretary determines appropriate.
Section 1173(c) through (f) of the Act indicates the Secretary must adopt standards for code sets for appropriate data elements for each listed health care transaction; security standards for health care information; standards for electronic signatures in coordination with the Secretary of Commerce, compliance with which will be deemed to satisfy both state and federal statutory requirements for written signatures for the listed transactions; and standards for the transmission of appropriate standard data elements needed for the coordination of benefits, sequential processing of claims, and other data elements for individuals who have more than one health plan.
Section 1174 of the Act requires the Secretary to review the adopted standards and adopt modifications to them, which include additions to the standards, as appropriate, but not more frequently than once every 12 months. Section 1174(b)(2)(B)(ii) of the Act requires that modifications must be completed in a manner that minimizes disruption and cost of compliance.
Section 1175 of the Act prohibits health plans from refusing to conduct a transaction as a standard transaction. /1/ It also prohibits health plans from delaying the transaction, or adversely affecting or attempting to adversely affect, a person or the transaction itself on the ground that the transaction is in standard format. It establishes a timetable for covered entities to comply with any standard, implementation specification, or modification as follows: for an initial standard or implementation specification, no later than 24 months (or 36 months for small health plans) following its adoption; for modifications, as the Secretary determines appropriate, but no earlier than 180 days after the modification is adopted.
FOOTNOTE 1 Defined at 45 CFR 162.103. END FOOTNOTE
Sections 1176 and 1177 of the Act establish civil money penalties (CMPs) and criminal penalties to which covered entities may be subject for violations of HIPAA Administrative Simplification rules. HHS administers the CMPs under section 1176 of the Act and the
The original HIPAA provisions are discussed in greater detail in the
2. Amendments to HIPAA Administrative Simplification by the Affordable Care Act
Section 1104(c)(3) of the Affordable Care Act reiterated the original HIPAA requirement to adopt a health claims attachment standard, and directed the Secretary to promulgate a final rule to establish a transaction standard and a single set of associated operating rules. Section 1104(c)(3) of the Affordable Care Act requires that the adopted standard be "consistent with the X12 Version 5010 transaction standards" and indicates that the Secretary must adopt the standard and operating rules by
B. Prior Rulemaking
In the Transactions and Code Sets final rule, we implemented some of the HIPAA Administrative Simplification requirements by adopting standards for electronic health care transactions developed by SSOs, and medical code sets to be used in those transactions. We adopted X12 Version 4010 standards for administrative transactions, and the
Since then, we have adopted a number of modifications to the HIPAA standards, most recently in a
In the
C. Standards and Code Sets Organizations
In this section, we discuss information about the organizations responsible for developing and maintaining the transaction standards and code sets that we are either proposing or discussing in this proposed rule. Information about each organization's balloting process--the process by which they vet and approve the products they develop and changes thereto--is available on their respective websites, links to which are provided in this section of this rule.
As we have discussed, the law requires any standard adopted under HIPAA to be developed, adopted, or modified by an SSO. Section 1171 of the Act provides that an SSO is an organization accredited by the
1. X12 (http://www.x12.org/)
X12 develops and maintains standards for the electronic exchange of business-to-business transactions. An ANSI-accredited organization, X12 membership is open to all individuals and organizations. An X12 subcommittee known as Subcommittee N: Insurance (X12N) develops and maintains electronic standards specific to the insurance industry, including health care insurance. The subcommittee, which is comprised of volunteers, develops standards for electronic health care transactions for common administrative activities including: claims, remittance advice, claims status, enrollment, eligibility, authorizations and referrals, and electronic health care claims attachments. The X12N subcommittee is responsible for obtaining consensus on the standards from the entire organization, and produces draft documents that are made available for public review and comment, which the subcommittee addresses as necessary before voting on any proposal. Proposals must then be reviewed and ratified by a majority of the voting members of the X12N subcommittee and the executive committee of X12 itself.
2. Health Level Seven (HL7) (www.HL7.org)
HL7 is an ANSI-accredited SSO that develops and maintains standards for the exchange, integration, sharing, and retrieval of electronic health information that supports clinical practice and the management, delivery and evaluation of health services. Its domain is principally clinical data and its specific emphasis is on the interoperability between health care information systems. HL7, whose membership is open to all individuals and organizations, focuses its interface requirements on the entire health care organization rather than on a particular subset of the health care industry.
HL7 conducts a three-step process to establish standards. First, a technical committee develops standards through a voting process. All HL7 members are eligible to vote on standards, regardless of whether they are members of the committee that developed the standard. Non-members may also vote on a given ballot for a standard, though they must pay an administrative fee (that does not exceed the cost associated with an individual HL7 membership) associated with handling and processing. Second, HL7 technical committees vote on "recommendations," which require a two-thirds majority for approval. Third, any recommended standards are submitted to the entire HL7 body for approval and, if approved, are submitted to ANSI for certification.
3.
D. Industry Standards, Code Sets, and Implementation Guides
1. Electronic Data Interchange (EDI) and Transaction Standards
HIPAA transactions involve the electronic transmission of information between two parties to carry out health care-related financial or administrative activities, such as health insurance claims submissions and prior authorization requests, and HHS-adopted standards for those transactions represent uniform requirements for EDI of those transmissions.
The benefit of HIPAA standards is that they use a common interchange structure, eliminating covered entities' need to have information technology (IT) systems that accommodate multiple proprietary, and potentially continually changing, data formats. By enabling covered entities to exchange medical, billing, and other information to process transactions in a more expedient and cost-effective manner by reducing handling and processing time and eliminating the risk of lost paper documents, HIPAA standards can reduce administrative burdens, lower operating costs, and improve overall data quality.
HIPAA transaction standards specify: (1) data interchange structures (message transmission formats); and (2) data content (all the data elements and code sets inherent to a transaction, and not related to the format of the transaction). Implementation specifications detail the nature, location, and content format of each piece of information transmitted in a transaction. Standardization of transactions also involves: specification of the data elements that are exchanged; uniform definitions of those specific data elements in each type of electronic transaction; identification of the specific codes or values that are valid for each data element; and specification of the business actions each party must take to ensure the exchange of administrative transactions occurs smoothly and reliably, regardless of the technology employed.
a. Implementation Guides--X12
As discussed previously, X12 develops and maintains standards for the electronic exchange of business-to-business transactions. The X12N subcommittee (X12N) publishes transmission standards that apply to many lines of business, not just health care. For example, the X12N 820 message format for premium payment may be used for automobile and casualty insurance, not just health insurance. X12 implementation specifications, referred to by the industry as "implementation guides" and written collaboratively by X12N workgroups, make these general standards functional for industry-specific uses. The specifications are based on X12 standards but contain detailed instructions for using the standard to meet a specific business need. X12's implementation specifications for HIPAA transaction standards adopted by the Secretary are known as "Technical Reports Type 3" (TR3); an example is the X12 standard adopted as the HIPAA standard for the health plan premium payments transaction, the ASC X12 Standards for Electronic Data Interchange Technical Report Type 3--Payroll Deducted and Other Group Premium Payment for Insurance Products (820),
Each X12N implementation guide has a unique version identification number (for example, 004010, 004050, or 005010), where the highest version number represents the most recent version. HHS adopted updated versions of the X12 standards in the Modifications final rule (74 FR 3296). We are proposing to adopt a Version 6020 standard for one of the HIPAA transactions, the rationale for which we discuss in section II. of this proposed rule.
b. Implementation Guides--HL7
HL7's Payer/Provider Information Exchange Workgroup develops standards for electronic health care attachments. The workgroup, which includes industry experts representing health care providers, health plans, and health technology vendors, is also responsible for creating and maintaining the implementation guides, which are sets of instructions and associated code tables that describe, list, or itemize the content, format, and code to be sent, and specify how such information is to be conveyed in an electronic health care attachment.
An HL7 standard that we are proposing to adopt in this proposed rule is the Clinical Document Architecture (CDA), which is an XML-based (a computer programming language) markup standard that specifies the encoding, structure, and semantics of clinical documents for purposes of transmitting attachment information. XML-coded files have the same characteristics and information as hard copy documents, so regardless of how data are sent within a transaction, they can be read and processed by both people and machines. Some health care attachments may not be conducive to XML formatting, such as medical imaging, video, or audio files. An important CDA feature is that it allows the entire body of an electronic document to be replaced by an image, for example, a scanned copy of a page or pages from a medical record. Although a header still supports automated document management, the clinical content can be conveyed by image or text document.
HL7 also produces the Consolidated CDA (C-CDA), an implementation guide that provides specifications for formatting document templates, depending on whether they are structured or unstructured, enabling the CDA to create numerous specific document types (templates). The HL7 C-CDA implementation guide document templates are designed to be electronic versions of the most common types of paper document attachment information. Attachment information not included in a template may be created by using instructions included in the proposed unstructured document implementation guide; supported unstructured formats include MSWORD, PDF, Plain Text, RTF Text, HTML Text, GIF Image, TIF Image, JPEG Image, and PNG Image.
2. Code Sets
Transaction data content standardization involves identifying the specific codes or values for each data element. Health care EDI requires many types of code sets, including large medical data code sets and classification systems for medical diagnoses, procedures, and drugs, and smaller code sets to identify categories, such as type of facility, currency, or units, or a specific state within
3. Implementation Guides as HIPAA Standards
Section 1172(d) of the Act directs the Secretary to establish specifications for implementing each of the adopted standards. As we explained previously, SSOs have developed various "Implementation Guides" by which to implement the same standards for different business purposes. We are proposing an approach we have taken with previous HIPAA rules that adopted a specific "Implementation Guide" as both the "standard" and the "implementation specifications" for each health care transaction.
In pursuing this approach, we were mindful that section 1104(c)(3) of the Affordable Care Act requires that the Secretary promulgate a final rule to establish a transaction standard and a single set of operating rules for health care attachments that is "consistent with the X12 Version 5010 transaction standards." We interpret this requirement to mean that the proposed health care attachment implementation specifications must be compatible with X12 standards generally, meaning any standard we adopt for attachment information can be electronically transmitted by an X12 transmission standard in the same transaction. In this rule, we are proposing to adopt Version 6020 of the X12 standards. The Affordable Care Act was enacted in 2010, at which time we had recently adopted Version 5010 of the X12 standards. A decade later, and with X12 continuing to publish newer versions of its standards, we interpret the Affordable Care Act's mandate as referencing the then-current standards (the X12 Version 5010), but the Affordable Care Act did not specifically require a static standard in perpetuity, as that would be incongruent with the HIPAA standards paradigm.
In section II. of this proposed rule, we are proposing to adopt transaction standards that can be used together in a single electronic transmission. HL7 has noted that an extensive architecture already exists for information exchange based on the HIPAA transactions and code sets, which architecture is currently being used by the same stakeholders who would use the health care attachments transactions, so adoption of this architecture using X12 standards could have the least impact on covered entities. /2/
FOOTNOTE 2 Transcript of NCVHS Subcommittee on Standards Hearing on Electronic Attachments Standards and Operating Rules,
Independent of that concept, we are also aware that there are other types of standards being developed and piloted by SSOs. We solicit comment on this discussion and any alternative implementation specifications that may be considered consistent with X12 Version 5010.
E. NCVHS Recommendations to the Secretary
The NCVHS (https://ncvhs.hhs.gov/) is a statutory advisory committee responsible for providing HHS with recommendations on health information policy and standards. It does so by, among other things, convening regular forums for interaction with industry groups on key issues related to population health, standards, privacy and confidentiality, and data access and use. Pursuant to HIPAA, the NCVHS advises HHS on the adoption of standards, implementation specifications, code sets, identifiers, and operating rules for HIPAA transactions.
The NCVHS has held a number of hearings, and made several sets of recommendations to the Secretary (see https://ncvhs.hhs.gov/reports/recommendation-letters/) on claims attachments standards; we briefly summarize them here. The NCVHS Standards Subcommittee held a
CAQH established the
The Subcommittee held a second hearing on attachments on
The NCVHS held another hearing on health care attachments on
Finally, and most recently, on
We recognize that there is ongoing debate and no definitive industry consensus about the role of attachments (i.e., documents) as opposed to data (i.e., a string of data elements not structured within a document). While the vision with APIs [(Application Programming Interfaces)] based on FHIR(R) [(Fast Healthcare Interoperability Resources)] seems to be driving toward more of a data-driven transaction, we see more than sufficient industry demand for a document-based attachment standard, and we do not foresee any imminent demise of the utility of digital documents. We suggest short-term publication of an attachment rule, with consideration for emerging standards based on recent input from industry and other advisory group discussions. This could add immediate value for industry and could support future actions as HIPAA's procedural requirements may be updated to allow for non-document type digital attachment data. /3/
FOOTNOTE 3 "Recommendations to Modernize Aspects of HIPAA and Other HIT Standards to Improve
Based on the NCVHS's previous recommendations to the Secretary, and particularly in consideration of its most recent
F. Other Industry Recommendations
1. Consensus-Based Organization Support
Industry consensus-based organizations have demonstrated the maturity of the NCVHS-recommended standards to support health care business needs and described the opportunities inherent in the adoption of health care attachments standards to integrate administrative and clinical data, such as in automating and streamlining workflows that, today, are primarily manual processes and sources of significant administrative burden.
FOOTNOTE 4 "Guidance on Implementation of Standard Electronic Attachments for Healthcare Transactions," available at https://www.wedi.org/2017/11/17/guidance-on-implementation-of-standard-electronic-attachments-for-healthcare-transactions/ (
* An overview of attachments.
* A discussion of resources needed to have a successful implementation of attachments standards.
* A review of current processes for requesting and responding to the need for attachment information.
* Examples of implementation approaches in the industry.
* A review of Electronic Attachment Business flows for Claims, Prior Authorizations and Notification.
* Business use cases and examples.
* Guidance on how to embed additional information within the applicable X12N transaction.
In
FOOTNOTE 5 "CAQH CORE Report on Attachments: A Bridge to a Fully Automated Future to Share Medical Documentation," available at https://www.caqh.org/sites/default/files/core/core-attachments-environmental-scan-report.pdf (
Shortly after, in
FOOTNOTE 6 "Moving Forward: Building Momentum for End-to-End Automation of the Prior Authorization Process," available at https://www.caqh.org/sites/default/files/core/white-paper/CAQH-CORE-Automating-Prior-Authorization.pdf (
2. Other Recent Public Comment Support
On
In preparation for its
FOOTNOTE 7 https://ncvhs.hhs.gov/wp-content/uploads/2020/10/Public-Comments-CAQH-CORE-Operating-Rules-for-Federal-Adoption-August-2020r.pdf END FOOTNOTE
We solicit comments on other standards or alternative approaches in development, for example the use of FHIR Clinical Data Exchange (CDex) as discussed in an NCVHS recommendation letter, /8/ including how they may be considered "consistent with the X12 Version 5010 transaction standards."
FOOTNOTE 8 https://ncvhs.hhs.gov/wp-content/uploads/2022/04/Recommendation-Letter-HIT-Standards-Modernization-to-Improve-Patient-Care-March-30-2022.pdf. END FOOTNOTE
III. Provisions of the Proposed Rule
A. Overview
This rule proposes to adopt new standards and modify a currently adopted standard which we believe would meet a health care business need to integrate administrative and clinical data. These proposed actions would facilitate streamlined prior authorization processes that would help minimize clinical response times, reduce potential barriers to the transition to value-based payments, and significantly reduce administrative burden on provider and health plan organizations. /9/ Consistent with NCVHS recommendations and collaborative industry organizations and stakeholders' input, we believe these industry consensus-based standards are sufficiently mature for adoption and that covered entities are ready to implement them.
FOOTNOTE 9 CAQH CORE Report on Attachments: "A Bridge to a Fully Automated Future to Share Medical Documentation", CAQH CORE,
Nearly every health plan has various requirements for health care providers to sometimes submit additional information beyond that contained in a HIPAA transaction. These requirements may be communicated to providers via contracts, manuals, or online databases of payment rules. This additional information may enable a health plan to make an administrative decision regarding whether a particular service is "covered," or about the medical necessity of a service a provider has rendered or intends to render, or for other purposes. The information a health plan requires may, for example, include medical documentation to support health care claims payment, referral authorizations, enrollee eligibility inquiries, coordination of benefits, workers' compensation claims, post-payment claims auditing, and provider dispute resolution. /10/
FOOTNOTE 10 Letter from NCVHS to the Secretary of HHS,
A health care provider may transmit attachment information either in response to a health plan's specific request for the information (solicited), or, in certain situations, in the absence of a specific request (unsolicited). A "solicited" attachment transmission occurs where a health care provider transmits an attachment pursuant to a health plan's specific electronic request for attachment information. Conversely, a health care provider's transmitting to a health plan electronic attachment in the absence of a health plan's specific electronic request is known as an "unsolicited" transmission, and usually occurs pursuant to pre-established requirements for attachment information set forth in trading partner agreements or other guidance that specifies when additional information must be submitted to support certain diagnoses, items, services, or medications.
Although providers may transmit this additional information electronically via an attachment to a transaction, currently providers frequently transmit via manual processes that often involve paper mail, fax, and phone because there are no adopted HIPAA standards for health care attachments.
We are proposing standards herein to address these issues; in doing so, we need to define the term "attachment information."
B. Proposed Definition of Attachment Information
We propose to define "attachment information" at
* A health care claims or equivalent encounter information transaction, as described in
* A referral certification and authorization transaction, as described in
We use the term "attachment information" in our proposed definition of the health care attachments transaction at
The NCVHS recommended defining attachments as "any supplemental documentation needed about a patient(s) to support a specific health care-related event (such as a claim, prior authorization, or referral) using a standardized format," and we have incorporated key aspects of their recommendation into our proposed definition of attachment information. /11/ We have attempted to ensure that our proposed definition is broad and general enough to include all possible patient-related information that could be generated with respect to health care services, and have done this in several ways.
FOOTNOTE 11 NCVHS Letter to the Secretary of HHS on Recommendations for the Electronic Health Care Attachment Standard,
Documentation: First, we believe the word "documentation," which the NCVHS recommended and that we include in our proposed definition, is adequately broad to indicate the wide scope of information the definition should cover.
Supplemental: Second, the NCVHS recommended the definition specify that the documentation be "supplemental." In and of themselves, the health care claims and prior authorizations transactions, which the proposed health care attachments transactions would support, do not provide the documentation that would be furnished by a health care attachments transaction. To express that the documentation would be supplemental, our proposed definition indicates that we are referring to documentation "that is not included" in a health care claims transaction or prior authorization transaction, and we include specific references to the regulatory provisions defining the health care claims and prior authorization transactions. Should we propose to adopt health care attachments transaction standards to support additional transactions, we would likely propose to broaden our definition of attachment information to include regulatory references to them.
Needed: Third, the NCVHS recommended that the definition specify the supplemental documentation should be "needed" by a health plan to enable it to decide whether to pay a claim or authorize the provision of health care; our proposed definition accounts for this with the language "enables the health plan to make a decision about health care."
C. Proposed Code Set, Transaction Definitions, and Standards
We are proposing to adopt certain industry consensus standards that, when used together, provide the functionality necessary for the transmission of electronic health care attachment information. /12/ In this section, we describe proposed new requirements for: (1) a code set to be used for health care attachments transactions; (2) X12 standards for requesting and transmitting attachment information and HL7 standards for clinical information content; and (3) electronic signatures standards.
FOOTNOTE 12 For additional information about the business and operational processes involved in the exchange of these standards, we refer readers to the aforementioned
1. Code Set (LOINC for HIPAA Attachments)
Health plans and health care providers must have a clear and unambiguous way to specify attachment information--for example, a discharge summary, surgical operation note, or cardiovascular disease consult note--to be transmitted or requested in a health care attachments transaction.
The LOINC code set was developed for the following three principal purposes:
* To identify the specific kind of information that a health plan electronically requests of a health care provider and a health care provider electronically transmits to a health plan; for example, a discharge summary or a diagnostic imaging report.
* To specify certain optional modifier variables for attachment information, such as, for example, a time period for which the attachment information is requested.
* For structured attachment information, to identify specific HL7 Implementation Guide: LOINC Document Ontology document templates.
This rule proposes numerous implementation specifications containing specific instructions for how to utilize the LOINC for HIPAA Attachments with respect to those three purposes. Where an implementation specification requires the use of LOINC, it instructs users to utilize the codes valid at the time a transaction is initiated, similar to how other nonmedical data codes sets in HIPAA implementation specifications are treated. Regenstrief's website maintains online tools to help users search the LOINC database for specific LOINC codes or map local terms to LOINC codes (https://loinc.org/attachments). To improve ease of use, Regenstrief released and enhanced the search functionality to the SearchLoinc tool (https://loinc.org/search-app/). In addition, Regenstrief offers the LOINC Attachments Knowledge Base (https://loinc.org/attachments) to help users better find and utilize LOINC codes and resources such as mapping. Regenstrief maintains a twice-yearly release cycle, and covered entities would be expected to utilize the LOINC for Attachments codes, as specified by the relevant implementation specification. In our discussion of each implementation specification, we describe in more detail how each uses LOINC.
2. Electronic Health Care Attachments Transactions
In this section, we propose to adopt standards for requesting and transmitting attachment information (as we have proposed to define that term in
a. Scope of Health Care Attachments Transactions
Section 1173(a) of the Act requires the Secretary to adopt standards for "Health claims attachments," and section 1104(c)(3) of the Affordable Care Act reiterated that requirement, directing the Secretary to promulgate a final rule to adopt a transaction standard and a single set of associated operating rules. The attachments standards we are proposing satisfy the requirement to adopt a standard to support health care claims, but they also support prior authorization transactions. Hereafter we refer to "health care attachments" to refer to attachments for claims as well as prior authorization transactions instead of "health claims attachments," which only includes the former.
Historically, the referral certification and authorization transaction has had among the lowest implementation rates of all the HIPAA transactions, likely attributable to the fact that we have not yet adopted standards for attachments. In a 2016 report, the CAQH CORE Index /13/ noted that the uptake rate for such transactions being conducted fully electronically was only 18 percent, even 5 years after the adoption of Version 5010 of the X12 278 standard. The report also indicated that more than 50 percent of prior authorization transactions were conducted through proprietary web portals and automated phone calls as a means to conform to business processes due to the lack of an adopted health care attachments standard. Four years later, the 2020 CAQH Index reported only limited progress, with the uptake rate having increased to only 21 percent. As we have discussed, health plans frequently require attachment information before approving requests for prior authorization for health care services. Although section 1173(a)(1)(A) of the Act does not specifically require the Secretary to adopt attachments standards with respect to prior authorization transactions, section 1173(a)(1)(B) of the Act requires the Secretary to adopt standards for other appropriate financial and administrative transactions, consistent with the goals of improving the operation of the health care system and reducing administrative costs.
FOOTNOTE 13 CAQH CORE "2016 CAQH INDEX(R) A Report of Healthcare Industry Adoption of Electronic Business Transactions and Cost Savings" https://www.caqh.org/sites/default/files/explorations/index/2016-caqh-index-report.pdf?token=qV_hI4H5. END FOOTNOTE
However, we are not proposing to adopt attachments standards for all health care transaction business needs. Not only would it be challenging to identify standard specifications and appropriate codes for the full array of different health care attachment types used today, but we also believe it is important that covered entities should consider gaining experience with a limited number of standard electronic attachment types so that technical and business issues can be identified to inform potential future rulemaking for other electronic attachments standards.
We request comment on alternative standards and approaches that can address the challenges described previously.
b. Proposed Definition of the Health Care Attachments Transaction
We are proposing to add a new Subpart T to 45 CFR part 162--Health Care Attachments. In Subpart T, in new
We are proposing the following three types of transmissions:
* In SEC 162.2001(a)(1) and (a)(2), a health care attachments transaction is either of two different types of transmissions, both of which are sent from a health care provider to a health plan and where the type of information being transmitted in both is attachment information.
* In SEC 162.2001(b), a health care attachments transaction is one type of transmission that is sent from a health plan to a health care provider, and where the type of information being transmitted is a request for attachment information.
The purpose for the transmission described in
3. Proposed Adoption of Electronic Health Care Attachments Transaction Standards
As noted earlier, the NCVHS has held a number of hearings and made several sets of recommendations to the Secretary on attachments standards. /14/ By letter dated
FOOTNOTE 14 https://ncvhs.hhs.gov/reports/recommendation-letters/. END FOOTNOTE
FOOTNOTE 15 See "Recommendations for the Electronic Health Care Attachment Standard," https://ncvhs.hhs.gov/wp-content/uploads/2018/03/2016-Ltr-Attachments-July-1-Final-Chair-CLEAN-for-Submission-Publication.pdf. END FOOTNOTE
The NCVHS noted that its recommended standards represented a collaboration between X12 and HL7, with X12 providing for existing provider/payer EDI, and HL7 providing for the CDA. Specifically, the NCVHS recommended that HHS adopt the following standards for attachment-related transactions:
* For requesting attachments, the following standards:
++ For claim-related attachment requests, the ASC X12N 277 Health Care Claim Request for Additional Information.
++ For non-claim-related attachment requests, the ASC X12N 278 Health Care Service Review--Request for Review and Response--Response.
* For attachment message content and format in the transmission of attachment information, the following standards:
++ The HL7 CDA R2--Consolidated CDA Templates for Clinical Notes R2.1.
++ The HL7 Attachment Supplement Specification Request and Response Implementation Guide R1.
++ The Attachment Type Value Set: Logical Observation Identifier Names and Codes (LOINC) developed and maintained by the
++ The HL7 Implementation Guide for CDA Release 2: Additional CDA R2 Templates--Clinical Documents for Payers--Set 1.
* For the routing/envelope of attachment information, the following standards:
++ The ASC X12N 275 Additional Information to Support a Health Care Claim or Encounter.
++ The ASC X12N 275 Additional Information to Support a Health Care Services Review.
The health care attachments standards we are proposing are those recommended by the NCVHS, and discussed in its
While the NCVHS did not recommend specific versions of the X12N attachments standards, we are proposing to adopt the X12N Versions 6020 for both the X12N 277 standard, that is, the X12N 277--Health Care Claim Request for Additional Information (006020X313), as well as for the X12N 278--Health Care Services Request for Review and Response Version (006020X315) standard for the referral certification and authorization transaction. We are proposing to adopt Version 6020 of these standards because they better harmonize with the X12N 275--Additional Information to Support a Health Care Claim or Encounter Version (006020X314) and the X12N 275--Additional Information to Support a Health Care Services Review Version (006020X316) standards we are proposing to adopt for a provider to transmit attachment information.
Although it may be possible to use different versions of the standards for health plan requests for, and provider transmissions of, attachment information, X12 recommended to the NCVHS that all parties to those transactions use Version 6020 of the standards as they are most compatible with each other. /16/
FOOTNOTE 16 Transcript of NCVHS Subcommittee on Standards Hearing on Electronic Attachments Standards and Operating Rules,
a. Proposed Adoption of X12N Standards for Health Care Attachments Transactions
(1) Proposed Adoption of Standards for Request From a Health Plan to a Health Care Provider for Attachment Information
(a) X12N 277--Health Care Claim Request for Additional Information (006020X313)
At
The X12N 277 contains two noteworthy fields, which we discuss sequentially. The first is the health plan assigned claim control number, which allows for document reassociation. A health plan assigns a claim control number to associate its request with a provider's electronic health care claim. The health care provider then uses the health plan assigned claim control number in the X12 275 standard in the health care attachments transaction, discussed later in this proposed rule, that it transmits to the health plan, enabling the health plan to associate the attachment information with the previously submitted health care claim.
The other noteworthy X12N 277 field is for LOINC for HIPAA Attachments. The X12N 277 standard requires the use of the appropriate LOINC for HIPAA Attachments data element to identify the specific attachment information the health plan is requesting. The previously referenced 2017 WEDI whitepaper illustrates how the LOINC code is used in an X12 277 standard in the following hypothetical scenario: A provider performs a particular surgery for which there is no HCPCS code and sends the health plan a health care claim using a Not Otherwise Classified (NOC) procedure code. The health plan requires additional information about the procedure to adjudicate the claim, and sends the health care provider an X12N 277 Health Care Claim Request for Additional Information request using the appropriate LOINC for HIPAA Attachments code to specify the surgical operative note it needs. /17/
FOOTNOTE 17 Workgroup for Electronic Data Interchange (
(b) X12N 278--Health Care Services Request for Review and Response (006020X315)
At
(2) Proposed Adoption of Standards for Response From a Health Care Provider to a Health Plan for Attachment Information
(a) X12 275--Additional Information to Support a Health Care Claim or Encounter (006020X314)
We propose to adopt, at
The X12N 275--Additional Information to Support a Health Care Claim or Encounter standard may be used with respect to both solicited and unsolicited attachment information. Using the previous example of a surgery for which there is not a HCPCS code, in the case where a health plan has solicited attachment information, the provider would reply to the X12N 277 request from the plan using the X12N 275 to convey the operative note as the attachment information. In the unsolicited scenario, the provider could concurrently transmit the X12N 275--Additional Information to Support a Health Care Claim or Encounter and a claim using the X12N 837 to enable the health plan to make a decision about the claim at the time of initial claim processing.
We note that the X12N 275--Additional Information to Support a Health Care Claim or Encounter claims attachment standard, as well as the X12N 275--Additional Information to Support a Health Care Services Review prior authorization standard (discussed in this section of this proposed rule), do not themselves contain claim or prior authorization attachment information. Rather, the standards serve as the electronic envelope for attachment information that is embedded in an HL7 standard. We describe in detail the specific HL7 standards for embedding attachment information in this section of the proposed rule, but the critical concept is that the health care attachment information is transported by the X12N 275 standard.
(b) X12N 275--Additional Information To Support a Health Care Services Review (006020X316)
We propose, at
As we described in greater detail in our proposal to adopt the X12 275--Additional Information to Support a Health Care Claim or Encounter, this standard also can be sent in a solicited or unsolicited manner. Using our example of a surgery for which there is no HCPCS code, for solicited attachment information the provider would reply to the X12N 278 request from the health plan using the X12N 275 standard that conveys the operative note. In the unsolicited scenario, the provider could concurrently transmit the X12N 275 Additional Information to Support a Health Care Services Review and a prior authorization request using the X12N 278 to enable the health plan to make a decision about the prior authorization without additional requests for information.
B. Proposed Adoption of HL7 Implementation Guides for Health Care Attachment Information
The HL7 CDA standard is the only currently available SSO-created, NCVHS-recommended standard in
We are proposing to adopt the following three HL7 implementation guides as HIPAA standards for the attachment information included in health care attachments transactions:
* HL7 Implementation Guide for CDA Release 2: Consolidated CDA Templates for Clinical Notes (US Realm) Draft Standard for Trial Use Release 2.1, Volume 1--Introductory Material,
* HL7 Implementation Guide for CDA Release 2: Consolidated CDA Templates for Clinical Notes (US Realm) Draft Standard for Trial Use Release 2.1, Volume 2--Templates and Supporting Material,
* HL7 CDA R2 Attachment Implementation Guide: Exchange of C-CDA Based Documents, Release 1,
Generally, the Attachment Implementation Guide specifies how to combine HL7 and X12 standards to transmit health care attachments transactions. For example, it contains instructions with respect to how to construct electronic health care attachments transactions, including how to attach and send the attachment information using the proposed X12N health care attachments standards. It also contains instructions for health plans to utilize the necessary LOINC codes for health plans to request health care attachments from a health care provider, and for providers to identify health care attachments document templates when transmitting them to a health plan. For the transmissions described in proposed
We are also proposing that for the transmissions of attachment information from a health care provider to a health plan for the specified purposes, as described in proposed
Attachment information comes in two variants, "structured" and "unstructured," and the proposed HL7 standards support both. A structured document is one that has a high degree of organization that is able to be interpreted by a computer, includes a header that contains metadata about the clinical information found in the body of the document, and a structured body. The clinical information contained in the document is subdivided into systematic sections and entries that can be identified and sorted by a computer using descriptive codes. HL7 Volume One and Volume Two instruct readers how to assemble the segments into a standardized set of document sections known as a document "template," which is essentially a set of C-CDA components identified by a LOINC code, and include templates for the most common paper documents that serve as attachment information. An HL7 structured template is in a format that can be easily displayed in a human-readable format, while also enabling a computer to make an automated decision about a claim or a prior authorization request. Volume One and Volume Two also contain instructions for creating an unstructured document template for attachment information for which HL7 has not created a structured template. Unstructured documents still utilize an HL7 standard header that includes meta-data about the clinical information found in the document body, but the body does not contain tags that systematically identify the attachment information within. Examples of unstructured documents include medical imaging files, audio, video, and legacy attachment information such as scanned paper documents. Unstructured content may also include attachment information that is not collected in a health care environment, but that a health plan may require for payment decisions, such as delivery receipts, home inspection reports, or patient-created diabetic logs.
The Attachment Implementation Guide also specifies how to construct a health care attachments transaction when Volume One or Volume Two do not provide a document template for particular attachment information. The Attachment Implementation Guide contains three criteria that any document template to be used as a health care attachment must meet if it is not already specified in one of the proposed implementation guides: (1) the template must be developed and published through the HL7 standards process; (2) the new template must be designated by HL7 as being compatible with a C-CDA 2.1 implementation specification and for use in
C. Electronic Signatures
Section 1173(e)(1) of the Act provides that the Secretary, in coordination with the Secretary of Commerce, must adopt standards specifying procedures for the electronic transmission and authentication of signatures for HIPAA transactions. Pursuant to that requirement, we proposed to adopt standards for electronic signatures in the
Signatures play a vital role with respect to the documentation of health care, as a signature is often the only indicator available to health plans and health care providers that attachment information has been reviewed and approved by the service provider or other clinician with appropriate authority to supervise care. Health care entities recognize numerous legal and compliance best practices for clinician attestation of medical record documentation consistent with applicable federal and state laws and regulations, accreditation standards, payer requirements, documentation requirements for clinical services offered, and technology functionalities. /18/
FOOTNOTE 18 Electronic Signature, Attestation, and Authorship, AHIMA: https://bok.ahima.org/PdfView?oid=107152. END FOOTNOTE
Health care best practices, such as those of the
FOOTNOTE 19 "Guidelines for Medical Record Documentation",
1. Proposed Definition of Electronic Signature
An electronic signature can be any of a number of types of marks or data that indicate a signatory's intent to sign. Examples of electronic signatures include an online check box indicating acceptance, a name entered by the signer in an online form, a signing device at a commercial checkout line on which a customer writes his or her signature, and an image of a signature that was written by hand and then scanned into an electronic image format.
We are proposing to define the term "electronic signature" as broadly as possible to ensure that it meets health care providers' and health plans' needs now and can also encompass future electronic signature technologies. However, we propose to narrowly specify the scope of the required use of electronic signatures, such that their required use would be limited to just attachment information transmitted electronically in electronic health care attachments transactions. Accordingly, the electronic signature standard we are proposing at
At
2. Proposed Electronic Signature Standard
Electronic signatures vary in reliability and value based on the type of technology used, and any HIPAA electronic signature standard has to meet the needs of both health plans and health care providers that produce and use attachment information. Any standard that we adopt needs to support all of the current business functions and uses for signatures in the health plan payment decision process while providing assurance that attachment information is accurate and unaltered. The 1998 proposed rule that we mentioned previously, "Security and Electronic Signature Standards," enumerated three implementation features necessary to achieve these goals: user authentication, message integrity, and non-repudiation (63 FR 43257). These core features, developed in conjunction with the
Authentication is the ability of a health plan to identify and verify the identity of the provider who signed a document, and is a vital signature characteristic because such verification serves to validate the attachment information. Just as a health plan might compare a physical signature to a signature card to authenticate a health care provider's identity, an electronic signature must provide a method of authentication. Some forms of electronic signatures do not allow for authentication; for example, a typed signature line in a word processing document that indicates it was signed by a physician does not have any unique traits that would permit authentication by a health plan.
Because some electronic signatures can be readily manipulated, there must also be a mechanism to ensure that signed attachment information remains unaltered since the time it was affixed; this feature is called message integrity. To maintain message integrity, there must be a way to electronically validate that the attachment information signed by the health care provider and sent to the health plan are identical. Without such a mechanism it would be possible, for example, to alter the amount or type of the medical item (such as, medication, durable medical equipment, a medical service, etc.) ordered by a physician after he or she had completed and signed the order.
Finally, an electronic signature standard must embody a feature known as nonrepudiation, which provides strong assurance of identity such that it is difficult for a signatory to later claim that the electronic representation is not valid or that he or she did not sign the document. /20/ Nonrepudiation is a necessary feature of an electronic signature for health care attachments transactions because health plans will use attachment information to make administrative decisions about payment for health care services and may deny payment to a health care provider based on the information in electronically signed attachments.
FOOTNOTE 20
An electronic signature standard must manifest each of these three features to suffice for attachment information in electronic health care attachments transactions. For example, were a signing system to incorporate authentication and nonrepudiation but lack a mechanism to ensure message integrity, a health plan could not be confident that the attachment information had not been altered since being signed. Or, were a signing system to incorporate nonrepudiation and message integrity but lack a mechanism for authentication, the health plan receiving the attachment information would be assured that the content had not been altered and that someone had signed, but it could never be certain of the actual signatory. In the previously discussed 1998 and 2005 proposed rules, HHS identified digital signature technology as the only electronic signature approach offering the features of authentication, message integrity, and nonrepudiation. We continue to believe that digital signature technology is the only electronic signature technology that supports all three features.
We considered proposing, as an electronic signature standard, the specifications for electronic signatures that are included in the HL7 implementation guides we are proposing here for electronic health care attachments transactions. But we decided not to pursue that route because the specifications included in those guides do not support authentication, message integrity, and nonrepudiation.
However, HL7 has also developed an implementation guide called the HL7 Implementation Guide for CDA Release 2: Digital Signatures and Delegation of Rights, Release 1 (hereafter Digital Signatures Guide), with supplemental specifications that add support for authentication, message integrity, and nonrepudiation to their other published implementation guides. The Digital Signatures Guide promotes these three features by utilizing digital signature technology to implement identity management using digital certificates, encryption requirements to support message integrity, and multiple signed elements to support nonrepudiation. As we previously noted, a digital signature is an electronic stamp that contains information about both the user creating the signature and the document that is being signed. Digital signatures are created using digital certificates to create a secure computer code that can be used later to authenticate the signer. At the same time, the certificate is used to create another computer code, usually referred to as a hash, which can be used by a computer to verify that the document has not been changed since it was originally signed; this is a mechanism to ensure the integrity of the signed document. In both cases, the codes are encrypted so the receiver knows that the codes themselves have also not been altered, enabling the receiver to be confident that the signature was applied by the authenticated individual.
We note that the Digital Signatures Guide does not include requirements for when a document must be signed and by whom. As previously discussed, requirements with respect to who may deliver health care and how it must be documented via signature vary greatly and are developed by health plans and outlined in their provider compliance manuals, trading partner agreements, and other contractual requirements between health plans and health care providers. We do not seek to regulate clinical best practices for documentation or interfere with health plans' business needs. Therefore, we are not proposing to specify when an electronic signature must be required, but, instead, we defer to the industry to continue to establish those expectations. We would also limit the scope of the required use of electronic signatures to just health care attachments transactions. Accordingly, we are proposing to require that, where a health care provider uses an electronic signature in a health care attachments transaction, the signature must conform to the implementation specifications in the Digital Signatures Guide. Specifically, we propose to adopt, at
We solicit comments on the proposed definition of electronic signature and the proposed HL7 Implementation Guide as the attachment information electronic signatures standard.
D. Proposed Modification to a HIPAA Standard
1. Modifications to Standards
Section 1174 of the Act requires the Secretary to review the adopted standards and adopt modifications to them as appropriate, but not more than once every 12 months. Modifications must be completed in a manner that minimizes disruption and cost of compliance. Per section 1175 of the Act, if the Secretary adopts a modification to a HIPAA standard or implementation specification, the compliance date for the modification may not be earlier than the 180th day following the date of the adoption of the modification. The Secretary must consider the time needed to comply due to the nature and extent of the modification when determining compliance dates, and may extend the time for compliance for small health plans if the Secretary deems it appropriate.
Section 162.910 sets out the standards maintenance process and defines the role of SSOs and Designated Standard Maintenance Organizations (DSMOs). An SSO is an organization accredited by the ANSI that develops and maintains standards for information transactions or data elements. The two SSOs applicable to this proposed rule are the Accredited Standards Committee X12 (X12) and Health Level Seven (HL7). On
Section 162.910 also sets forth the procedures for the maintenance of existing standards and the adoption of modifications to existing standards and new standards. Under
* Open public access.
* Coordination with other DSMOs.
* An appeal process for the requestor of the proposal or the DSMO that participated in the review and analysis if either were dissatisfied with the decision on the request.
* An expedited process to address HIPAA content needs identified within the industry.
* Submission of the recommendation to the NCVHS.
Any entity may submit change requests with a documented business case to support the recommendation to the DSMO, which receives and processes those change requests. The DSMO reviews the request and notifies the SSO of the recommendation for approval or rejection. Should the changes be recommended for approval, the DSMO also notifies the NCVHS and suggests that a recommendation for adoption be made to the Secretary of HHS. Information pertaining to the designation of a DSMO and its responsibilities can be found in the Transactions Rule and the Notice, which were both published on
The modification we are proposing in this rule was developed through a process that conforms with
FOOTNOTE 21 https://ncvhs.hhs.gov/transcripts-minutes/transcript-of-the-february-16-2016-ncvhs-subcommittee-on-standards/. END FOOTNOTE
FOOTNOTE 22 https://ncvhs.hhs.gov/wp-content/uploads/2018/03/2016-Ltr-Attachments-July-1-Final-Chair-CLEAN-for-Submission-Publication.pdf. END FOOTNOTE
2. Modification to Referral Certification and Authorization Transaction Standard
As just discussed, the NCVHS recommended that HHS adopt the referral certification and authorization transaction standard (ASC X12N 278) for non-claims-related attachment requests and responses. Although the NCVHS did not recommend a specific version of the standard, we are proposing to adopt Version 6020 of the X12N 278 because Version 6020 better harmonizes with the Additional Information to Support a Health Care Services Review Version--X12N 275- (006020X316) standard we are proposing to adopt for providers transmitting attachment information. As we also discussed, while it may be possible to use different versions of the standards for health plan requests for, and provider transmissions of, attachment information, X12 advised against it, recommending to the NCVHS /23/ that all parties to those transactions use Version 6020 of the standards as they are most compatible with each other.
FOOTNOTE 23 Transcript of NCVHS Subcommittee on Standards Hearing on Electronic Attachments Standards and Operating Rules,
Adopting Version 6020 of the X12N 278 for referral certification and authorization transactions standard to replace Version 5010 of the X12N 278 would be a modification to a standard under HIPAA, similar to the previous modifications we adopted when we moved from Version 4010 to Version 5010 for the X12 standards. Version 6020 of the X12N 278 includes several changes, some of which are maintenance changes, and some of which represent more significant improvements over Version 5010. The two most significant changes each represent technical improvements and structural changes to the standard:
* One important change will better support referral certification and authorization transactions for dental services. Currently, health care providers are able to accurately report tooth status utilizing Version 5010 of the X12N 837 for health care claims, but Version 5010 of the X12N 278 cannot support reporting tooth status in health care referral certification and authorization transactions. Version 6020 of the X12N 278 expands support for reporting the status of individual teeth, which enables a health care provider to specifically indicate a missing tooth, extracted tooth, tooth to be extracted, or impacted tooth in a health care referral certification and authorization transaction. We expect this improvement in the X12N 278 to minimize or eliminate administrative delays attributable to providers having to convey relevant individual tooth information outside of the standard transactions process.
* Version 6020 revises and expands the drug authorization segment, which includes fields necessary to, for example, identify a drug, specify quantity of drug requested, specify drug dosage requested, and accommodate related procedure codes. Because Version 5010 does not enable entities to supply this additional information, health plans and providers must utilize cumbersome alternative methods to communicate drug information. Therefore, we also expect this improvement to minimize or eliminate administrative delays attributable to providers having to convey relevant drug information outside of the standard transactions process.
The referral certification and authorization transaction under
E. Proposed Compliance Dates
We are proposing to adopt new standards and a modification to a standard in this proposed rule. Section 1104(c)(3) of the Affordable Care Act, which requires the Secretary to adopt a transaction standard for health claims attachments, prescribes a 2-year compliance date for all covered entities and makes no special provision for small health plans, unlike the original HIPAA. In this rule, we are proposing that the same health care attachments standards would apply to both claims and prior authorization attachments transmissions. As the transmission standard for each type of attachment transaction transmission would be the same, we believe the compliance date for both types should also be the same. In addition, because we are proposing to treat the two attachments process together as one transaction in new Subpart T, adopting the same compliance timeframe for all covered entities would avoid the complications a bifurcated compliance timeframe--one for claims processes and another for prior authorization processes--would raise.
When the Secretary adopts a modification to a HIPAA standard, section 1175(b)(2) of the Act requires that the compliance date may not be earlier than the 180th day following the date of adoption. The Secretary must consider the time needed to comply due to the nature and extent of the modification when determining a compliance date, and may extend the time for small health plans to achieve compliance if the Secretary deems it appropriate. The adoption date of a standard or a modification is the effective date of the final rule in which the adoption or modification is established. The effective date is the date the rule amends the Code of Federal Regulations (CFR), which is typically 60 days after the date of publication in the
1. Proposed Compliance Date for Health Care Attachments and Electronic Signatures Standards
We are proposing to adopt the following seven standards for health care attachments transactions and electronic signatures:
* HL7 CDAR2: Attachment Implementation Guide: Exchange of C-CDA Based Documents, Release 1--
* HL7 Implementation Guide for CDA Release 2: Consolidated CDA Templates for Clinical Notes (US Realm) Draft Standard for Trial Use Release 2.1, Volume 1--Introductory Material,
* HL7 Implementation Guide for CDA Release 2: Consolidated CDA Templates for Clinical Notes (US Realm) Draft Standard for Trial Use Release 2.1, Volume 2--Templates and Supporting Material,
* X12N 275 Additional Information to Support a Health Care Services Review (06020X316).
* X12N 275 Additional Information to Support a Health Care Claim or Encounter (06020X314).
* X12N 277--Health Care Claim Request for Additional Information (006020X313).
* HL7 Implementation Guide for CDA Release 2: Digital Signatures and Delegation of Rights, Release 1.
In accordance with section 1104(c)(3) of the Affordable Care Act, which sets a 2-year compliance date, and which makes no provision for an extended time for small health plans to achieve compliance, we are proposing that the compliance date for these standards would be 24 months after the effective date of the final rule for all covered entities. We would specify these compliance dates in
2. Proposed Compliance Date for Modification
Section 1175(b)(2) of the Act requires the Secretary to determine an appropriate compliance date for the implementation of modified standards, such as the modification of the X12N 278 standard from Version 5010 to Version 6020, by taking into account the time needed to comply due to the nature and extent of the modification. The Act also requires that the compliance date be no earlier than the last day of the 180-day period beginning on the date the modification is adopted (the effective date of the final rule in which the modification is adopted). As discussed previously, we are proposing Version 6020 of the X12N 278 as the standard for referral certification and authorization transactions to be used by a health plan in conjunction with Version 6020 of the X12N 275, which a health care provider would use to electronically transmit attachment information to a health plan in support of a prior authorization request. As the X12N 278 will feature in the new health care attachments transaction, we believe it is important to align the compliance dates for the proposed modification to the X12N 278 standard and the health care attachments standards. Accordingly, we are proposing that covered entities would need to comply with Version 6020 of the standard 24 months after the effective date of the final rule. We would reflect this compliance date in
F. Proposed Incorporation by Reference
This proposed rule proposes to incorporate by reference: (1) X12 275--Additional Information to Support a Health Care Claim or Encounter (006020X314); (2) X12N 275--Additional Information to Support a Health Care Services Review (006020X316); (3) X12N 277--Health Care Claim Request for Additional Information (006020X313); and (4) X12N 278--Health Care Services Request for Review and Response Version (006020X315) standard for the referral certification and authorization transaction implementation guides.
The X12 275--Additional Information to Support a Health Care Claim or Encounter implementation guide provides instructions to assist those who send additional supporting information or who receive additional supporting information to a health care claim or encounter. The implementation guide for X12N 275--Additional Information to Support a Health Care Services Review implementation guide contains the data elements used to communicate individual patient information requests and patient information (either solicited or unsolicited) between separate health care entities in a variety of settings to be consistent with confidentiality and use requirements. Instructions to collect patient information consisting of demographic, clinical and other supporting data are provided.
The X12N 277--Health Care Claim Request for Additional Information implementation guide contains the format and establishes the data contents of the Health Care Information Status Notification Transaction Set for use within the context of an Electronic Data Interchange (EDI) environment. This transaction set can be used by a health care payer or authorized agent to notify a provider, recipient, or authorized agent regarding the status of a health care claim or encounter or to request additional information from the provider regarding a health care claim or encounter, health care services review, or transactions related to the provisions of health care.
X12N 278--Health Care Services Request for Review and Response Version implementation guide contains the format. It establishes the data contents of the Health Care Services Review Information transaction set used within the context of an Electronic Data Interchange (EDI) environment. This transaction set can be used to transmit health care service information, such as subscriber, patient, demographic, diagnosis, or treatment data for the purpose of request for review, certification, notification, or reporting the outcome of a health care services review. Expected users of this transaction set are payors, plan sponsors, providers, utilization management, and other entities involved in health care services review.
This proposed rule proposes to incorporate by reference: (1) HL7 CDA R2 Attachment Implementation Guide: Exchange of C-CDA Based Documents, Release 1,
The HL7 CDA R2 Attachment Implementation Guide: Exchange of C-CDA Based Documents, Release 1,
HL7 Implementation Guide for CDA Release 2: Consolidated CDA Templates for Clinical Notes (US Realm) Draft Standard for Trial Use Release 2.1, Volume 1--Introductory Material,
The materials we propose to incorporate by reference are available to interested parties and can be inspected at the
IV. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the
* The need for the information collection and its usefulness in carrying out the proper functions of our agency.
* The accuracy of our estimate of the information collection burden.
* The quality, utility, and clarity of the information to be collected.
* Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
The burden associated with the information collection requirements contained in
In addition, the collection requirements associated with this demonstration do not impose information collection and record keeping requirements, because they meet the "information" definition exception under 5 CFR 1320.3(h)(4) which states: "Information" does not generally include items in the following categories: (4) Facts or opinions submitted in response to general solicitations of comments from the public, published in the
If you comment on this information collection, that is, reporting, recordkeeping or third-party disclosure requirements, please submit your comments electronically as specified in the ADDRESSES section of this proposed rule. Comments must be received on/by
V. Regulatory Impact Analysis
A. Statement of Need
This rule proposes to adopt and modify standards, pursuant to HIPAA Administrative Simplification statutory provisions, for the electronic transmission of health care attachments, inclusive of attachments standards for both health care claims and prior authorizations. The health care industry has made it clear via NCVHS testimony,
B. Overall Impact
We have examined the impacts of this rule as required by Executive Order 12866 on Regulatory Planning and Review (
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects, distributive impacts, and equity). Section 3(f) of Executive Order 12866 defines a significant regulatory action as an action that is likely to result in a rule: (1) having an annual effect on the economy of
A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects (
C. Regulatory Flexibility Analysis
Executive Order 13272 requires that HHS thoroughly review rules to assess and take appropriate account of their potential impact on small businesses, small governmental jurisdictions, and small organizations (as mandated by the Regulatory Flexibility Act (RFA)). The RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. If a proposed rule may have a significant economic impact on a substantial number of small entities, then the proposed rule must discuss steps taken, including alternatives considered, to minimize the burden on small entities. The RFA does not define the terms significant economic impact or substantial number.
The RFA generally defines a small entity as (1) a proprietary firm meeting the SBA size standards, (2) a not-for-profit organization that is not dominant in its field, or (3) a small government jurisdiction with a population of less than 50,000. The North American Industry Classification System (NAICS) is used in the
FOOTNOTE 24 http://www.sba.gov/content/small-business-size-standards. END FOOTNOTE
Table 1-SBA Size Standards for Applicable NAICS Industry Codes
NAICS code NAICS description SBA standard
( $ in million)
446110 Pharmacies and drug stores 30.0
522320 Financial transaction processing, reserve, and clearinghouse 41.5
activities
524114 Direct health and medical insurance carriers 41.5
541511 Custom computer programming services 30.0
62111 Offices of physicians 12.0
621210 Offices of dentists 8.0
621491 Health plans 35.0
6221 Hospitals 41.5
Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than
Table 8 in the impact analysis presents the estimated implementation costs of these proposals on all entities we anticipate would be affected by the rule. The data in that table are used in this analysis to provide cost information.
1. Number of Small Entities
We used the latest available (2017) Census business data records and other information to determine the number of affected entities, as summarized in Table 2.
Table 2-Number of Affected Entities
Type of entity Number of entity firms or
establishments
Hospitals 5,544
Physicians 171,722
Dentists 125,329
Pharmacies 19.234
Private Health Plans 772
Government Health Plans 3
Clearinghouses 162
Vendors 1,000
Totals 323,766
Based on the latest available (2017) Census business data records, we estimate that 321,639 health care provider entities may be considered small entities either because of their nonprofit status or because of their revenues, as detailed in Table 3. Approximately two percent (5,544) of these are hospitals, 57 percent (171,722) are physician practices, and 41 percent (125,329) are dental practices. To count hospitals, we are using data at the level of establishments, and to count physicians and dentists we are using data at the level of firms, as we did in the
FOOTNOTE 25 Fast Facts on
The Census business data records indicate that in 2017 there were a total of 19,234 pharmacy firms, and we estimate that most of these qualify as small entities. Available data do not permit us to clearly distinguish small pharmacy firms from firms that are parts of larger parent organizations, but we use employee size as a proxy for the firm size subject to the SBA size standard. For purposes of this analysis, we assume the firms with more than 500 employees (190) represent chain pharmacies and those with fewer than 500 employees (19,044) represent independently-owned open- or closed-door pharmacies. The 19,044 firms with fewer than 500 employees represented 20,901 establishments and accounted for total annual receipts of
For 2017, the
Clearinghouses provide transaction processing and data translation services to both providers and health plans that would be critical to implementing this proposed rule. The applicable NAICS category includes many types of financial transaction processing firms other than those affected by this rule, so the Census business data cannot be used to identify small entities of interest. In previous rulemaking, we have identified a largely consolidated market (74 FR 3312). More recently, in 2020, the national clearinghouse association, Cooperative Exchange, indicated its 23 member companies represent over 90 percent of the clearinghouse industry and provide services to over 750,000 provider organizations, through more than 7,000 payer connections and 1,000 HIT vendors. /26/ While we do not have data on the size of these firms, or on the other firms constituting the remaining less than 10 percent of the market, we continue to believe the firms in this segment are either quite large or are affiliated with other very large firms, and do not include them in this small entity analysis. In the
FOOTNOTE 26 From testimony submitted for the
Other vendors affected by this rule include provider PMS and EHR technology system vendors. Counting the affected entities in these two segments is complicated, in part because they are increasingly integrated. A health care provider entity's PMS and EHR systems may be bundled in one product offering, semi-integrated affiliated systems, or entirely independent systems offered by separate vendors. /27/ We have not identified publicly available data on the number, size, or market share of these specific industry stakeholders. NAICS industry category 541511, Custom Computer Programming Services, seems to be the closest category. In 2017, the category included over 62,000 firms with 99 percent of these having less than 500 employees and 1 percent having 500 or more employees. However, this total seems out of proportion to other potential indicators of market size, leading us to believe it significantly overstates the affected entities of interest to the proposed rule. For instance, the aforementioned Cooperative Exchange description of member firm scope cited connections with 1,000 HIT vendors; 2019 market research estimates indicate there are over 500 vendors offering some type of EHR product; /28/ the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program final rule (85 FR 25642) estimated the number of certified HIT developers with health IT products capable of recording electronic health information certified in the 2015 Edition of health IT certification criteria to be 458; and the
FOOTNOTE 27 The true cost of switching EHRs.
FOOTNOTE 28 Who are the largest EHR vendors.
FOOTNOTE 29 https://www.ehra.org/membership/ehra-members. END FOOTNOTE
2. Costs to Small Entities
To determine the impact on the health care providers considered small entities for this analysis (identified in the previous section), we used the 2017 Census business data to collect revenue estimates and compared these to the high and low estimates for the range of costs calculated for each industry segment later in this analysis, as summarized in Table 8. We calculated the percentage of revenues represented by the high and low estimates, and none exceeded the 3 to 5 percent of revenue threshold, as summarized in Table 3. Thus, for purposes of the RFA analysis, we can conclude there is not a significant impact on small entities.
Table 3-Analysis of Implementation Burden on Small Covered Entities
Entity type Small entities (#) Revenue Implementation Cost/revenue
( $ in billions) cost range range
( $ in millions) (%)
Pharmacies 19,044 282 0-0 NA
Vendors NA NA NA NA
Clearinghouses NA NA NA NA
Health plans NA NA NA NA
Programmers NA NA NA NA
Physicians 171,722 485 218-345 0.04-0.09
Dentists 125,329 126 149-299 0.12-0.24
Hospitals 5,544 994 466-932 0.05-0.09
Subtotal 321,639 1,887 833-1,666 0.04-0.09
3. Alternatives Considered
This rule proposes to adopt standards for "health care attachments," which support both health care claims, as required by section 1173(a) of the Act, and prior authorization transactions, as recommended to the Secretary by NCVHS. It is our understanding that the standards recommended to the Secretary by NCVHS, and that we are proposing to adopt in this rule, are the only standards applicable to health care attachments that are ready for full implementation across the industry. Therefore, we considered the following regulatory alternatives: (1) not adopt standards for health care attachments, allowing for the industry's continued use of multiple processes, (2) wait to adopt standards for health care attachments until alternate standards, such as FHIR standards, are ready for full implementation and recommended to the Secretary by the industry, and (3) adopt a different version of the X12 implementation specifications than Version 6020, the version proposed to adopt in this rule. We chose to proceed with the proposals in this rule after identifying significant shortcomings with each of these alternatives.
We chose to propose to adopt attachments standards rather than allow for continued use of multiple standards because of the well-documented costs and administrative burdens associated with the many manual or partially electronic processes currently in use. These burdens were recently detailed in the 2020 CAQH Index. In response to CAQH surveys, industry stakeholders reported that the lack of federal standards and mandates has been a principal barrier to adoption of fully electronic standardized health care transactions. /30/ Based on these survey responses, should we not adopt standards for health care attachments, most attachment transactions and many prior authorization transactions would continue to be conducted through fully manual processes. Not adopting standards for attachment transactions would also mean forgoing the opportunity to reduce the unnecessary back-and-forth between providers and health plans, accelerate claims adjudication and patient service approval timeframes, and reduce provider resources spent on manual follow-up activities. To the extent that future payer policies continue to trend toward increased levels of prior authorization or health care attachments requirements, these burdens could also increase.
FOOTNOTE 30 Last accessed
Similarly, we chose not to hold off on proposing the adoption of attachment standards until alternate standards, such as FHIR standards, are available and recommended by the industry because we believe that adoption and implementation of the specifications in this proposed rule can immediately reduce the costs and burdens associated with the lack of national standards. While we are aware of HL7's efforts to create alternative implementation specifications to support health care attachments transactions, we note that at the time of writing this proposed rule, these FHIR implementation specifications have not been finalized nor have they been tested. We also note that the HL7 CDA standard we are proposing to adopt in this proposed rule is the only currently available SSO-created, NCVHS-recommended standard with published implementation specifications designed to support both claims and prior authorization attachment transactions. We believe that the industry's readiness for improvements to the manual or partially electronic process currently in place, as outlined the CAQH stakeholder surveys and supported by NCVHS's recommendation to adopt the specifications proposed in this rule, support proposing the adoption of attachments standards at this time. However, we invite comment on our understanding of the readiness of possible implementation specifications for health care attachments that support both claim and prior authorization transactions and whether the industry supports postponement of an adopted standard as it did for the previously mentioned proposed rule in the 2005
Finally, we chose to propose adoption of Version 6020 of the X12 implementation specifications, rather than an alternate version, such as Version 5010, because Version 5010 does not fully support attachments transactions. Version 6020 resolves technical issues and limitations in Version 5010 to enable attachments transactions that support both health care claims and prior authorization transactions. We also invite comment on any alternative implementation specifications that were not considered but meet the criteria outlined in this proposed rule.
4. Conclusion
As referenced earlier in this section, we use a baseline threshold of 3 to 5 percent of revenues to determine if a rule would have a significant economic impact on affected small entities. The small health care entities do not come close to this threshold. Therefore, the Secretary has certified that this proposed rule would not have a significant economic impact on a substantial number of small entities. However, because of the relative uncertainty in the data, the lack of consistent industry data, and our general assumptions, we invite public comments on the analysis and request any additional data that would help us determine more accurately the impact on all categories of entities affected by the proposed rule.
In addition, section 1102(b) of the Act requires us to prepare a Regulatory Impact Analysis if a rule would have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. This proposed rule would not have a significant effect on the operations of a substantial number of small rural hospitals because these entities would rely on contracted health information technology (HIT) vendors for the majority of implementation investment and efforts such hospitals elect to implement. We note that health care providers may choose not to conduct transactions electronically. Therefore, they would be required to use these standards only for transactions that they conduct electronically and would be expected to do so only when the benefits clearly outweigh the costs involved. Therefore, the Secretary has certified that this proposed rule would not have a significant impact on the operations of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates would require spending more in any one year than threshold amounts in 1995 dollars, updated annually for inflation. In 2022, this threshold is approximately
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has federalism implications. This proposed rule would have a substantial direct effect on state or local governments, could preempt state law, or otherwise have a federalism implication because state Medicaid agencies or their contractors would be implementing new standards and a modified version of an existing standard for which there would be expenses for implementation and wide-scale testing.
D. Anticipated Effects
The objective of this regulatory impact analysis is to summarize the costs and benefits of the following proposals:
* Adopting new standards for the exchange of health care attachment information consisting of--
++ A code set to be used for health care attachments transactions;
++ Proposed X12 standards for requesting and transmitting attachment information and HL7 standards for clinical information content; and
++ Proposed electronic signatures standards.
* Modifying the existing standard for referral certification and authorization by updating from Version 5010 to Version 6020.
This portion of the analysis is informed by a review of an earlier environmental scan produced for us in 2016 by the
Consistent with statutory and regulatory requirements, any recommendations for the adoption of HIPAA standard updates are the outcome of an extensive consensus-driven process that is open to all interested stakeholders. The standards development process involves direct participatory input from representatives of the industry stakeholders required to utilize the transactions.
For purposes of this analysis, we use the segmentation of health care industry stakeholders laid out in the 2009 Modifications final rule with some additional detail on vendors supporting the integration of the administrative and clinical data. As discussed in this proposed rule, providers and payers continue to use manual processing for health care attachments, therefore, these stakeholders are relevant for purposes of this RIA because there is no adopted health care attachments standard. As noted in the 2017 WEDI white paper, most payers send hard copy letters to request additional information to support a claim or prior authorization submitted by the provider. /31/ These segments consist of the following:
FOOTNOTE 31 Guidance on Implementation of Standard Electronic Attachments for Healthcare Transactions
* Providers
++ Hospitals
++ Physicians
++ Dentists
++ Pharmacies
* Health Plans
++ Private Health Plans and Issuers
++ Government Health Plans: Medicare, Medicaid, and
* Clearinghouses
* Vendors
++ PMS Vendors
++ EHR Vendors
In analyzing the effects of this proposed rule, we referenced the 2019 and 2020 CAQH Index Reports issued on
FOOTNOTE 32 https://www.caqh.org/sites/default/files/explorations/index/report/2019-caqh-index.pdf. END FOOTNOTE
FOOTNOTE 33 https://www.caqh.org/explorations/caqh-index-report. END FOOTNOTE
For two types of transactions directly addressed by this proposed rule, attachments, and prior authorization, the 2020 CAQH Index estimates the annual industry national savings opportunity of full automation adoption of these transactions at
In contrast to the data on labor cost savings, we are not aware of any reports or other industry estimates on the level of additional investments needed to fully implement these electronic processes for requesting and submitting attachment information, or the proportion of such costs that might be passed on to provider or health plan firms. By reviewing testimony submitted to the NCVHS and conducting web searches, such as for plan, clearinghouse, and vendor electronic data interchange (EDI) instructions and services, we understand some stakeholder segments have already largely built or acquired the capacity to implement these proposals (albeit possibly in inconsistent and proprietary ways in the absence of federal standards and operating rules). Similarly, based on NCVHS testimony, others (particularly health care providers and their vendors) have partially implemented the standards. /34/ Thus, we conclude that implementation and readiness to fully implement the proposed standards vary among and within covered entity industry segments.
FOOTNOTE 34 NCVHS Letter to the Secretary of HHS on Recommendations for the Electronic Health Care Attachment Standard,
We also believe it is likely that firms directly involved in deploying additional capacity, in particular in upgrading PMS or EHR functionality, would not voluntarily share proprietary and competitive, market-sensitive data on the level of additional investment needed or on the effects on customer fees. Therefore, as further explained in the discussion of cost calculations, we estimate the incremental costs involved not through projected cost build-up, but rather as a function of the level of impact of implementing the previous HIPAA-standard modifications. We seek comment on this approach and on the appropriateness of the aggregate level estimates; data reflecting estimated changes to firm-specific costs and customer-specific fees would preferably be presented in a manner that facilitates aggregation.
We do not have good information on the extent of adoption of the proposed electronic standards for attachment information among industry stakeholders because HHS has not adopted an electronic transaction standard for health care attachments. However, we believe there is good reason to expect the proposed regulatory requirements, combined with the administrative cost savings opportunities identified by CAQH, would incentivize broad adoption of these attachment standards and lead to a significant uptake of the prior authorization standard. The remainder of this section provides details supporting the cost-benefit analysis for our proposals.
1. Affected Entities
As with previous standard updates, all HIPAA covered entities would be affected by this proposed rule. Covered entities include all health plans, all health care clearinghouses, and health care providers that transmit health information in electronic form in connection with a transaction for which the Secretary has adopted a standard. Therefore, they would be required to use these standards only for transactions that they conduct electronically. See the Transactions and Code Sets rule for a discussion of affected entities (65 FR 50361).
In general, covered entities (or their vendors) would incur a number of one-time costs to implement the new and modified transactions in this proposed rule unless they have already implemented an adopted HIPAA standard, such as for prior authorization transactions. These costs would include analysis of business flow changes, software procurement or customized software development, integration of new software into existing provider/vendor systems, staff training, and collection of new data, testing, and transition processes. For some entities, new vendors may be needed for the creation and validation of the clinical documentation to be embedded in the attachment transactions. Systems implementation costs would account for most of the costs, with system testing alone likely accounting for a majority of costs for all covered entities. Ongoing operational costs would be expected to initially grow, as the implementation of electronic processes run in parallel with ongoing manual and partially automated processes, but to decline as higher proportions of transactions are automated. These HIT-related costs would be offset by significant reductions in labor costs for what are today largely manual processes to locate, collect, package, and mail clinical records needed to support requests for additional documentation to support claims and prior authorization requests. Other offsetting cost savings are expected from lower postage and other mailing costs, reductions in reprocessing volume due to higher clean claim acceptance rates, and delay in receiving payment. /35/ /36/
FOOTNOTE 35 NCVHS Letter to the Secretary of HHS on Recommendations for the Electronic Health Care Attachment Standard,
FOOTNOTE 36 In a regulatory impact analysis that, in accordance with OMB Circular A-4, takes a society-wide perspective, changes in timing of payments represent a transfer, rather than a net societal cost savings. END FOOTNOTE
It is likely that there are significant differences in readiness among payer and provider claims and prior authorization HIT systems, and we do not know the extent of incremental costs associated with HIT development, enablement (upgrade or licensing fees paid by users), or workflow adjustment and training to facilitate compliance with the standards proposed in this rule. So, though we are aware that the net benefits would likely vary among stakeholders, we lack the data to estimate these differential effects. An important consideration reflected in various industry testimonies submitted to the NCVHS is that some stakeholders, particularly smaller providers, would continue to have the option to leverage existing clearinghouses to provide these information exchange services based on negotiated rates. This is a standard practice today, where clearinghouses already manage 90 percent of the conversion of paper-to-electronic formats, as well as reformatting of non-compliant to compliant electronic claim transactions for the industry. Given the high costs of manual and partially electronic means for exchanging required information, we believe the impact of this rule would be significant net savings to the industry. However, the level and timing of uptake (as opposed to the retention of manual processes and clearinghouse intermediation) by provider entities are uncertain. We reflect this uncertainty with both the phasing in of and the estimation of minimum and maximums for costs and benefits. We solicit comments on this approach and our assumptions throughout this analysis.
2. Explanation of Cost Calculations
Based on consultation with industry workgroups, such as
Although the attachments standards we are proposing to adopt are initial standards, as described in section 1175 of the Act, health plans surveyed by CAQH in 2020 reported electronic transaction submission levels of 22 percent for attachments and 21 percent for prior authorizations. Therefore, while the specification for attachments requests by the health plan (X12 277) and the subsequent response from the provider (X12 276) have not previously been adopted under HIPAA Administrative Simplification, some payer and provider systems are already exchanging HIPAA electronic prior authorization transactions using the adopted standards. Moreover, the HL-7 C-CDA has been widely adopted pursuant to the ONC 2014 and 2015 Editions of Health Information Technology Certification Criteria specifying content exchange standards and implementation specifications for exchanging electronic health information. According to the latest available posted data, as of 2017, nearly 4 in 5 (80 percent) office-based physicians had adopted a certified EHR. /37/
FOOTNOTE 37 ONC Health IT Dashboard. Office-based Physician Electronic Health Record Adoption: https://dashboard.healthit.gov/quickstats/pages/physician-ehr-adoption-trends.php. END FOOTNOTE
Similarly, while the standards we are proposing to adopt for electronic signatures are also initial standards, we believe they have already been widely implemented by the industry. For example, in 2010 the
FOOTNOTE 38 Electronic Prescribing of Controlled Substances.
Given much of the industry has already implemented some or all of the implementation specifications we are proposing to adopt in this proposed rule, or versions of the implementation specifications we are proposing to adopt in this proposed rule, we believe the level of effort involved in implementing the entire set of proposed implementation specifications herein is more akin to implementing standards modifications than to implementing transactions standards for the first time. Therefore, we anchor our cost estimates on the final cost estimates, updated for inflation, /39/ in the Modifications final rule, and then make certain adjustments to address unique aspects of certain industry segments. While the systems required for implementing the specifications proposed for adoption in this proposed rule have been continuously updated since the publication of the Modifications final rule, the technologies within the proposed implementation specifications in this proposed rule are of the same type as those considered in the Modification rule and will be integrated into systems that continue to utilize the similar business models.
FOOTNOTE 39 Cost estimate ranges from the
The cost estimates in the Modifications final rule were based on an estimate of the total costs to implement the initial HIPAA transaction standards (Version 4010/4010A) and informed by industry interviews. /40/ To determine the costs for each provider sub-segment (that is, hospitals, physicians, and dentists), we established an estimate for what the total approximate Version 4010/4010A costs were for an individual entity within that sub-segment (based on the interviews and other data available through research) and then applied an estimated range of 20 to 40 percent of those costs to come up with estimated minimum and maximum costs for Version 5010. The range was accepted as a realistic proxy by all providers and plans who participated in the interviews. Through the course of the interviews, we identified more granular cost categories and reviewed these with the participants to help analyze and validate overall cost estimates by entity. The estimated cost for each individual entity within a segment was then multiplied by the number of entities to establish the estimated costs for entire segment.
FOOTNOTE 40 Version 5010 Regulatory Impact Analysis--Supplement.
With respect to the level and timing of the uptake of these standards, we assume that some portion of providers and their vendors may take longer to move from manual to fully automated transactions. For purposes of this analysis, we generally estimate that most stakeholders would incur costs over a 4-year period at the rate of 50 percent in the first implementation year, 30 percent in the second implementation year, and 10 percent each in the third and fourth years.
We note that, although many comments to the Modifications rule suggested we underestimated the costs, no substantive data or additional information was provided to counter our analysis at that time. We're not aware of more recent public research relating to costs of implementing modifications to HIPAA transaction standards. We invite public comments on our understanding and request any additional data that would help us determine more accurately the costs of implementing modifications to HIPAA transaction standards.
3. Explanation of Benefits Calculations
To determine the benefits for each segment of the industry, we primarily relied upon the 2020 CAQH Index. Based on survey responses, CAQH estimates that spending on labor time conducting attachment transactions accounts for about
The 2019 CAQH Index reported that the use of the electronic standard for prior authorizations has remained very low due to barriers such as provider awareness, vendor support, and inconsistent use of data content allowed in the standard, and the lack of an attachment standard to support the exchange of medical documentation. The 2020 CAQH Index reports that fully electronic prior authorization continues to have the lowest adoption rate of the medical transactions surveyed, although utilization between 2019 and 2020 increased by 8 percentage points to 21 percent. Since this rule proposes to adopt federal attachment standards, including those to address data content, we believe the proposed changes in this rule would substantially address these barriers and promote widespread adoption of electronic prior authorization processes. As described in section I.F. of this proposed rule, numerous organizations representing physician provider groups, insurance payers, health technology vendors, health care financial managers, and HIT standard advisory bodies have submitted recommendations to the Secretary strongly supporting this view.
CAQH reports that prior authorization is the most costly and time-consuming administrative transaction for providers, and administrative spending increased to
We utilize the CAQH national annual savings estimates as the basis for our benefits estimates. The CAQH national annual savings estimates are calculated based on potential savings moving from the reported state of 21 percent electronic processing for prior authorization transactions and 22 percent electronic processing for attachments to fully electronic processing. The total potential industry cost savings opportunity is an amount that declines as industry adoption increases. Although there was an apparent increase in electronic processing of prior authorization and health care attachments transactions from 2019 to 2020, we do not trend the benefits estimates forward because previously reported estimates of electronic processing adoption have tended to remain stable over a longer period of time. The CAQH estimation methodology only includes labor time savings, which it assesses to be the most significant component of savings, by far. We do not include estimates of other sources of savings, such as through elimination of mailing costs, so our benefit estimates may have a tendency toward understating actual industry savings. /41/ Because we believe that some portion of providers and their vendors may take longer to move from manual to fully automated transactions, we also assume a phased-in realization of the level of annual benefits projected by CAQH. For purposes of this analysis, we generally estimate that most stakeholders would realize the benefits in labor savings over a 3-year period at the rate of 50 percent in the first operational year, 75 percent in the second operational year, and 100 percent in and after the third year after the compliance date.
FOOTNOTE 41 On the other hand, CAQH developed estimates from the experience of entities that voluntarily automated, and extrapolation from such voluntary experience to the regulatory context may generate a tendency toward overestimation of savings, on a per-unit basis and/or in the aggregate. We welcome comments that would facilitate refinement of estimates. END FOOTNOTE
4. Hospitals
As previously discussed, to determine the costs for each health care provider sub-segment, we started with the minimum and maximum cost estimates in the Modifications final rule for each type of entity. For hospitals, those estimates were within a range of
FOOTNOTE 42 The true cost of switching EHRs.
Table 4-Attachments Costs Borne by Providers Versus Vendors
Entity type Proposed rule Provider share Vendor share
cost range (40%) (60%)
Physicians 665-1,329 266-532 399-797
Dentists 456-913 182-365 274-548
Hospitals 1,423-2,848 569-1,139 854-1,709
Subtotals 2,544-5,090 1,017-2,036 1,527-3,054
To determine the benefits for hospitals, we refer to the estimates of savings for medical providers reported by CAQH, and assume that hospitals would achieve 20 percent of these savings. We assume a rough 80/20 split between physicians and hospitals because we believe the vast majority of transactions needed to support claims and prior authorizations would come from clinician practices since plans and hospitals generally have other processes for utilization management of more expensive inpatient admissions and outpatient procedures. CAQH estimated the total annual savings opportunity for medical providers for fully automating attachments and prior authorization transactions to be
Table 5-Attachments Benefits by Entity
Entity type Estimated
annual
savings
range
(25%)
Pharmacies 0-0
Vendors 0-0
Clearinghouses 0-0
Private Health Plans 108-144
Government Health Plans 179-238
Physicians 390-520
Dentists 86-115
Hospitals 98-130
Total 860-1,147
With respect to timing of costs and benefits, we assume hospitals would have both the capital and business interest to move promptly to achieve the return on investment; would incur all costs during the 2-year implementation period; and would realize the full level of annual savings in and after the first operational year following the proposed compliance date, as summarized in Tables 8 and 9.
5. Physicians
We followed a similar methodology for estimating physician costs and benefits. For physicians, the Modifications final rule cost estimates were within a range of
To determine the benefits for physicians, we again referred to the estimates of savings for medical providers reported by CAQH and calculated the remaining 80 percent of these savings. CAQH estimated the total annual savings opportunity for medical providers for fully automating attachments and prior authorization transactions to be
6. Dentists
For dentists, we follow the same methodology for costs as we do for physicians. The Modifications final rule cost estimates for dentists were within a range of
Given that the 2020 CAQH Index did not report on the potential savings opportunity for dental providers for full automation of attachments transactions, we take a different approach to benefits estimation. Comments included in testimony submitted to the NCVHS in 2016 on the Attachment Standard /43/ (2016 NCVHS Hearing) indicated that dentists supported the proposal to make the X12N 275 transaction the standard vehicle for transporting attachment content to dental claims, but made no mention of the prior authorization transaction. These comments also indicated that many dental PMS vendor technologies may lack the capability to generate HL7 documents, requiring dentists to either upgrade existing systems or find alternative methods, such as using a clearinghouse or payer portals. Thus, we conclude that some dentists and their PMS vendors would incur costs associated with submitting attachment information to support claims, and others may maintain current manual or clearinghouse-mediated processes. Therefore, we assume that the savings opportunity for full automation of claims attachments for dentists would be a portion of the savings opportunity for medical providers. Since the total number of dental entities (125,329) is about 70 percent of the number of other provider entities (177,266, or 5,544 hospital establishments and 171,722 physician firms), we estimate their savings opportunity would be no greater than 70 percent of the annual
FOOTNOTE 43 NCVHS Subcommittee on Standards. Agenda of the
7. PMS and EHR Vendors
In testimony to the 2016 NCVHS Hearing,
FOOTNOTE 44 The true cost of switching EHRs.
Because vendors of certified electronic health record technology are already familiar with CDA for meeting requirements under the ONC Health IT Certification Program, we believe all EHR vendors have some ability to extract data for C-CDA templates, although all may not have fully implemented or provided this functionality as part of core product offerings. A review of some of the largest EHR vendor websites in
Similarly, we assume PMS vendors contracted with clients that have a certified EHR have already largely developed the ability to create the X12N 275 and X12N 278, even if this functionality has not been enabled for all customers, and that the majority of the additional cost would be associated with receiving and managing the C-CDA payload. Because of this pre-existing functionality, we are again persuaded that implementing these proposals is more akin to a standards upgrade than implementing a new standard for the first time. Based on 2020 CAQH Index results that report 22 percent of medical and 16 percent of dental attachment exchanges occurring electronically, we are aware that some provider vendors have already successfully implemented the transmission of electronic attachments. Without data on the extent of the gaps, or on the difference in readiness between EHR and PMS vendors, we assume similar costs across both types of vendors and treat them together. We also assume that other significant components of implementation costs would consist of trading partner testing and user training.
As the result of the estimates already described for hospitals, physicians, and dentists and the split with their HIT vendors in Table 4, we estimate that PMS and EHR vendor costs would add up across all customer segments to a range of
We have not identified any evidence that suggests there would be savings for this segment as the result of the changes in this proposed rule and do not include any estimates of benefits for this segment.
8. Clearinghouses
From remarks recorded at the 2016 NCVHS Hearing, /45/ we understand that by 2016 many entities in the clearinghouse industry had already fully implemented the standards proposed in this rule and were exchanging the transactions and clinical payloads with government and commercial health care entities, as well as with entities in other lines of business. Fundamental to the clearinghouse business role is the ability to normalize disparate data formats, including both structured and unstructured clinical data, and unwrap and convert the data into standard or proprietary formats based on the varying capabilities and needs of payer and provider clients. We assume that, by 2022, this ability has generally become the business norm throughout the clearinghouse industry. As a result, we assume that clearinghouses would not have significant new technology development costs as the result of our proposals, but would have significant new trading partner testing costs.
FOOTNOTE 45 Transcript of the
To estimate clearinghouse implementation costs, we considered a commenter, described in the Modifications final rule (74 FR 3318), that identified as a large clearinghouse and reported that projected costs would be at least
We have not identified any evidence that suggests there would be savings for clearinghouses as the result of the changes in this proposed rule and have not estimated any benefits for this segment.
Table 6-Clearinghouse Costs Firm size Large Small Total Firms (#) 23 139 162 Cost per Firm ( $ million) 4.3 1.8 Total Segment Cost ( $ million) 99 250 349Cost Range +/- 25% ( $ million) 262-436
9. Private Health Plans and Issuers
Based on our informal web searches in
FOOTNOTE 46 For example, see: Payer Access to EHRs: What Providers Need to Know.
In testimony to the 2016 NCVHS Hearing,
FOOTNOTE 47 A Path Toward Further Clinical and Administrative Data Integration. Final Report Of
In light of these considerations, we assume that the costs of implementation for health plans may be somewhat analogous to those for clearinghouses, but generally with fewer connections to test, since many transactions would be expected to continue to be exchanged through existing clearinghouse connections. Therefore, as summarized in Table 7, we estimate that private health plans would incur 50 percent of clearinghouse costs, and we increase that estimated range of
Table 7-Private Health Plan Costs Entity type Clearinghouses Private plans Firms (#) 162 772 Difference in # of Firms 4.8 Total cost from Table 6 ( $ in millions) 349 Plan cost (50% of above x multiple of firms) ( $ in millions) 838Cost Range +/- 25% ( $ in millions) 629-1,048
Given that we assume some portion of providers and their vendors may take longer to move from manual to fully automated transactions, we assume health plan testing costs would extend beyond the 2-year implementation period. So, for purposes of this analysis, we estimate that private health plans would incur costs over a 4-year period at the rate of 50 percent in the first implementation year, 30 percent in the second implementation year, and 10 percent each in the third and fourth years.
In estimating the benefits of the proposed rule for private health plans, we again referred to the estimates of savings reported by CAQH, but this time to those reported for plans. CAQH estimated the 2020 national annual plan savings opportunities for attachments and prior authorizations at
10. Government Health Plans
Similar to private health plans, we believe Medicare, Medicaid, and the Veteran's Administration systems have largely implemented the ability to receive and manage these transactions through their HIT processing vendors and contracted managed care plans, especially with respect to claims attachments, and would incur costs in rough magnitude to the impacts estimated in the Modifications final rule for testing and training. We assume these costs would again largely be borne by the contracted vendors under existing contractual terms and agreements. Accordingly, to calculate government health plan costs, we used the same range of costs estimated in the Modifications final rule of
To calculate government health plan benefits, we started with the point estimate of
11. Pharmacies
We believe pharmacies would generally not be impacted by the changes in this proposed rule. Comments from NCPDP submitted to the 2016 NCVHS Hearing indicated: that pharmacies use the X12N 837 to bill medications and supplies covered under the Medicare Part B program and for professional pharmacy services covered under a medical plan; the type of claims submitted by pharmacy providers using the X12N 837 rarely requires an attachment; the electronic prior authorization (
FOOTNOTE 48 NCVHS Subcommittee on Standards, Comments Received in Response to Request for Comment (Federal Register Notice 85 FR 37666] (on CAQH CORE Operating Rules)
FOOTNOTE 49 NCPDP White Paper on Pharmacy Professional Service Billing https://www.ncpdp.org/NCPDP/media/pdf/WhitePaper/Billing-Guidance-for-Pharmacists-Professional-and-Patient-Care-Services-White-Paper.pdf?ext=.pdf. END FOOTNOTE
12. Summary of Costs and Benefits for This Proposed Rule
Tables 8 and 9 are the compilation of the estimated costs and benefits for all of the standards proposed in this proposed rule.
Table 8-Estimated Minimum and Maximum Costs for Implementation of Attachment Standards-2025 Through 2034 Industry 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034 Total Hospitals 284.5 284.5 569 minimum Hospital 569.5 569.5 1,1395.0 maximum Physicians 133.0 79.8 26.6 26.6 266.0 minimum Physicians 266 159.6 53.2 53.2 532.0 maximum Dentists 91 54.6 18.2 18.2 182.0 minimum Dentists 182.5 109.5 36.5 36.5 365.0 maximum Pharmacies 0.0 0.0 0.0 0.0 0.0 minimum Pharmacies 0.0 0.0 0.0 0.0 0.0 maximum Private Health 314.5 188.7 62.9 62.9 629.0 Plans minimum Private Health 524 314.4 104.8 104.8 1,048.0 Plans maximum Government 192.0 115.2 38.4 38.4 384.0 Health Plans minimum Government 367 220.2 73.4 73.4 734.0 Health Plans maximum Clearinghouses 131 78.6 26.2 26.2 262.0 minimum Clearinghouses 218 130.8 43.6 43.6 436.0 maximum Vendors minimum 763.5 458.1 152.7 152.7 1,527.0 Vendors maximum 1,527 916.2 305.4 305.4 3,054.0 Total Minimums 1,910 1,260 325 235 0.0 0.0 0.0 0.0 0.0 0.0 3,819.0 Total Maximums 3,654 2,420.2 616.9 616.9 0.0 0.0 0.0 0.0 0.0 0.0 7,308.0
Table 9-Estimated Minimum and Maximum Benefits for Implementation of Attachment Standards-2025 Through 2034 Industry 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034 Total Hospitals 0.0 0.0 97.5 97.5 97.5 97.5 97.5 97.5 97.5 97.5 780.0 minimum Hospital 0.0 0.0 130.0 130.0 130.0 130.0 130.0 130.0 130.0 130.0 1,040.0 maximum Physicians 0.0 0.0 195.0 292.5 390.0 390.0 390.0 390.0 390.0 390.0 2,827.5 minimum Physicians 0.0 0.0 260.0 390.0 520.0 520.0 520.0 520.0 520.0 520.0 3,770.0 maximum Dentists 0.0 0.0 43 64.6 86.1 86.1 86.1 86.1 86.1 86.1 624.2 minimum Dentists 0.0 0.0 57.5 86.3 115.0 115.0 115.0 115.0 115.0 115.0 833.8 maximum Pharmacies 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 minimum Pharmacies 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 maximum Private Health 0.0 0.0 54.0 81.0 108.0 108.0 108.0 108.0 108.0 108.0 783.0 Plans minimum Private Health 0.0 0.0 72.0 108.0 144.0 144.0 144.0 144.0 144.0 144.0 1,044.0 Plans maximum Government 0.0 0.0 89.3 133.9 178.5 178.5 178.5 178.5 178.5 178.5 1,294.2 Health Plans minimum Government 0.0 0.0 119.0 178.5 238.0 238.0 238.0 238.0 238.0 238.0 1,725.5 Health Plans maximum Clearinghouse 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 minimum Clearinghouse 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 maximum Vendors minimum 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 Vendors maximum 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 Total Minimums 0.0 0.0 478.8 669.5 860.1 860.1 860.1 860.1 860.1 860.1 6,308.9 Total Maximums 0.0 0.0 638.5 892.8 1,147.0 1,147.0 1,147.0 1,147.0 1,147.0 1,147.0 8,413.3
E. Regulatory Review Costs Estimate
One of the costs of compliance with a proposed rule is the necessity for affected entities to review the rule in order to understand what it requires and what changes the entity would have to make to come into compliance. We assume that 323,766 affected entities (listed in Table 2) would incur some of these costs, as they are the entities that would have to implement the proposed changes. The particular staff involved in such a review would vary from entity to entity, but would generally consist of lawyers responsible for compliance activities (at all 323,766 entities) and individuals familiar with the technical X12N and HL7 standards at the level of a computer and information systems manager at private and government health plans, clearinghouses, and PMS and EHR vendors (a total of 1,937 entities). Using the Occupational Employment and Wages for
F. Accounting Statement
Whenever a rule is considered a significant rule under Executive Order 12866, we are required to develop an Accounting Statement. This statement must state that we have prepared an accounting statement showing the classification of the expenditures associated with the provisions of this proposed rule. Monetary annualized benefits and non-budgetary costs are presented using 3 percent and 7 percent discount rates.
Table 10-Accounting Statement-Accounting Statement: Classification of Estimated Expenditures, From FY 2025 to FY 2034
Category Primary estimate Minimum Maximum Source
estimate estimate
Benefits
Annualized monetized benefits:
7% Discount 670 574 765 RIA.
3% Discount 708 606 809 RIA.
Qualitative (un -quantified benefits) Increased productivity due to decrease
in manual processing; reduced delays in
patient care
Providers and health plans would benefit from efficiencies in resource use stemming from changes implemented by plans, clearinghouses, and vendors.
Costs
Annualized monetized costs:
7% Discount 700 474 926 RIA.
3% Discount 615 416 814 RIA.
Qualitative (un -quantified costs) None
Providers, health plans, and government plans would pay for IT staff and other contractors, as well as clearinghouses and vendors for changes in the forms of new and ongoing fees.
Transfers
Annualized monetized transfers: "on None None None.
budget"
Annualized monetized transfers: "off None None None
budget"
VI. Response to Comments
Because of the large number of public comments, we normally receive on
List of Subjects
45 CFR Part 160
Administrative practice and procedure, Computer technology, Health care, Health facilities, Health insurance, Health records, Hospitals, Medicaid, Medicare, Penalties, Reporting and recordkeeping requirements.
45 CFR Part 162
Administrative practice and procedures, electronic transactions, health facilities, health insurance, hospitals, incorporation by reference, Medicaid, Medicare, Reporting and recordkeeping requirements.
For the reasons set forth in this preamble, the
PART 160--GENERAL ADMINISTRATIVE REQUIREMENTS
1. The authority citation for part 160 continues to read as follows:
Authority:42 U.S.C. 1302(a), 42 U.S.C. 1320d-1320d-8, sec. 264 of Pub. L. 104 191, 110 Stat. 2033-2034 (42 U.S.C. 1320d-2 (note)), 5 U.S.C. 552; secs. 13400 and 13424, Pub. L. 111-5, 123 Stat. 258-279, and sec. 1104 of Pub. L. 111-148, 124 Stat. 146-154.
2. In
PART 162--ADMINISTRATIVE REQUIREMENTS
3. The authority citation for part 162 continues to read as follows:
Authority: 42 U.S.C. 1320d--1320d-9 and secs. 1104 and 10109 of Pub. L. 111-148, 124 Stat. 146-154 and 915-917.
4. Section 162.103 is amended by adding the definitions of "Attachment information" and "Electronic signature" to read as follows:
*****
Attachment information means documentation that enables the health plan to make a decision about health care that is not included in either of the following:
(1) A health care claims or equivalent encounter information transaction, as described in
(2) A referral certification and authorization transaction, as described in
*****
Electronic signature means an electronic sound, symbol, or process, attached to or logically associated with attachment information and executed by a person with the intent to sign the attachment information.
*****
5. Section 162.920 is amended by:
a. Revising the introductory text and paragraph (a) introductory text; and
b. Adding paragraphs (a)(19) through (22) and (e).
The revisions and additions read as follows:
Certain material is incorporated by reference into this part with the approval of the Director of the
(a) ASC X12,
(19) The X12N 275--Additional Information to Support a Health Care Claim or Encounter (006020X314),
(20) The X12N 275--Additional Information to Support a Health Care Services Review (006020X316),
(21) The X12N 277--Health Care Claim Request for Additional Information (006020X313),
(22) The X12N 278--Health Care Services Request for Review and Response (006020X315),
*****
(e)
(1) HL7 CDA R2 Attachment Implementation Guide: Exchange of C-CDA Based Documents, Release 1--
(2) HL7 Implementation Guide for CDA Release 2: Consolidated CDA Templates for Clinical Notes (US Realm) Draft Standard for Trial Use Release 2.1, Volume 1--Introductory Material,
(3) HL7 Implementation Guide for CDA Release 2: Consolidated CDA Templates for Clinical Notes (US Realm) Draft Standard for Trial Use Release 2.1, Volume 2--Templates and Supporting Material,
6. Section 162.1302 is amended--
a. In paragraph (c), by removing the phrase "standards identified in paragraph (b)(2)" and adding in its place the phrase "standard identified in paragraph (b)(2)(i)"; and
b. By adding paragraph (e).
The addition reads as follows:
*****
(e) For the period from
(1) Through [24 months from effective date of the final rule], the standard identified in paragraph (b)(2)(ii) of this section;
(2) On and after [24 months from the effective date of the final rule], the X12N 278--Health Care Services Request for Review and Response (006020X315) (incorporated by reference, see
7. Add subpart T, consisting of [Sec.]
Subpart T--Health Care Attachments
Sec.
162.2001Health care attachments transaction.
162.2002Standards for health care attachments transaction.
Subpart T--Health Care Attachments
A health care attachments transaction is the transmission of any of the following:
(a) Attachment information from a health care provider to a health plan for any of the following purposes:
(1) In support of a referral certification and authorization transaction, as described in
(2) In support of a health care claims or equivalent encounter transaction, as described in
(b) A request from a health plan to a health care provider for attachment information.
The Secretary adopts the following standards for the period on and after [24 months from effective date of the final rule]:
(a) For transmissions described in
(b) For transmissions described in
(1) HL7 Implementation Guide for CDA Release 2: Consolidated CDA Templates for Clinical Notes (US Realm) Draft Standard for Trial Use Release 2.1, Volume 1--Introductory Material,
(2) HL7 Implementation Guide for CDA Release 2: Consolidated CDA Templates for Clinical Notes (US Realm) Draft Standard for Trial Use Release 2.1, Volume 2 -- Templates and Supporting Material,
(c) For transmissions described in
(d) For transmissions described in
(e) For transmissions described in the following:
(1) Section 162.2001(b) that pertain to
(2) Section 162.2001(b) that pertain to
Dated:
Secretary,
[FR Doc. 2022-27437 Filed 12-15-22;
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