Request for Information: Electronic Prior Authorization Standards, Implementation Specifications, and Certification Criteria, 3475-3481 [2022-01309]
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Federal Register / Vol. 87, No. 15 / Monday, January 24, 2022 / Proposed Rules
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the National Coordinator for Health
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Request for Information: Electronic Prior
Division, Aircraft Certification Service.
Authorization Standards,
[FR Doc. 2022–01238 Filed 1–21–22; 8:45 am]
Implementation Specifications, and
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Request for Information: Electronic
Inspection of Public Comments: All
Prior Authorization Standards,
comments received before the close of
Implementation Specifications, and
the comment period will be available for
Certification Criteria
public inspection, including any
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a comment. Please do not include
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ACTION: Request for information
that you do not wish to share with the
SUMMARY: This request for information
general public. Such information
seeks input from the public regarding
includes, but is not limited to: A
electronic prior authorization standards, person’s social security number; date of
implementation specifications, and
birth; driver’s license number; state
certification criteria that could be
identification number or foreign country
adopted within the ONC Health IT
equivalent; passport number; financial
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Request for Information will be used to
number; any personal health
inform potential future rulemaking.
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DATES: To be assured consideration,
written or electronic comments must be proprietary. We will post all comments
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that are received before the close of the
comment period at https://
www.regulations.gov.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov or the Department
of Health and Human Services, Office of
the National Coordinator for Health
Information Technology, Mary E.
Switzer Building, Mail Stop: 7033A, 330
C Street SW, Washington, DC 20201
(call ahead to the contact listed below
to arrange for inspection).
FOR FURTHER INFORMATION CONTACT: Alex
Baker, Office of Policy, Office of the
National Coordinator for Health
Information Technology, 202–260–2048.
SUPPLEMENTARY INFORMATION:
I. Background
For purposes of this Request for
Information (RFI), prior authorization
generally refers to rules imposed by
healthcare payers that require approval
for a medication, procedure, device, or
other medical service be obtained prior
to payment for the item or service. Prior
authorization requirements are
established by payers to help control
costs and ensure payment accuracy by
verifying that an item or service is
medically necessary, meets coverage
criteria, and is consistent with standards
of care. Stakeholders have stated that
diverse payer policies, provider
workflow challenges, and technical
barriers create an environment in which
the prior authorization process is a
source of burden for patients, providers,
and payers; a cause of burnout for
providers; and a health risk for patients
when it delays their care.1
ONC’s Strategy on Reducing
Regulatory and Administrative Burden
Relating to the Use of Health IT and
EHRs,2 released in 2020, identified
challenges associated with the prior
authorization process, including: (i)
Difficulty in determining whether an
item or service requires prior
authorization; (ii) difficulty in
determining payer-specific prior
authorization requirements for those
items and services; (iii) inefficient use of
provider and staff time to navigate
communications channels such as fax,
telephone, and various web portals; and
1 For additional discussion of administrative
burden associated with the prior authorization
process, see the CMS Interoperability and Prior
Authorization proposed rule at 85 FR 82606.
2 Office of the National Coordinator for Health
Information Technology. Strategy on Reducing
Regulatory and Administrative Burden Relating to
the Use of Health IT and EHRs [PDF file]. February
2020. Retrieved from https://www.healthit.gov/
sites/default/files/page/2020-02/BurdenReport_
0.pdf.
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Federal Register / Vol. 87, No. 15 / Monday, January 24, 2022 / Proposed Rules
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(iv) unpredictable and lengthy amounts
of time to receive payer decisions. The
Strategy notes that payers and health IT
developers have addressed prior
authorization in an ad hoc manner with
interfaces that reflect individual payer
technology considerations, payer lines
of business, and customer-specific
constraints. In order to address these
issues, the Strategy included a number
of recommendations to strengthen
electronic prior authorization processes,
such as: Leveraging health IT to
standardize data and processes around
ordering services or equipment;
coordinating efforts to advance new
standards approaches; and incentivizing
adoption and/or use of technology that
can generate and exchange standardized
data to support documentation needs.
In order to further explore these and
other stakeholder recommendations,
and to build on recent efforts related to
electronic prior authorization, we seek
public comments on how the ONC
Health IT Certification Program
(Certification Program) could
incorporate standards, implementation
specifications, and certification criteria
to advance electronic prior
authorization.
a. ONC Health IT Certification Program
The Certification Program 3 is a
voluntary program under which health
IT developers can obtain ONC
certification for their health IT products.
Requirements for certification are
established by standards,
implementation specifications, and
certification criteria adopted through
rulemaking by the Secretary. The
Certification Program does not set any
requirements for healthcare providers
but supports the availability of certified
health IT for use by healthcare providers
under other federal, state, and private
programs.
The Certification Program currently
addresses electronic prior authorization
for medications as part of the
‘‘electronic prescribing’’ certification
criterion at 45 CFR 170.315(b)(3). On
May 1, 2020, ONC published in the
Federal Register the ‘‘21st Century
Cures Act: Interoperability, Information
Blocking, and the ONC Health IT
Certification Program’’ final rule (21st
Century Cures Act final rule). In this
rule, ONC adopted the National Council
for Prescription Drug Programs (NCPDP)
SCRIPT Standard, Version 2017071, for
electronic prescribing and specified
electronic prior authorization
transactions supported by the standard
3 For
more information, see https://
www.healthit.gov/topic/certification-ehrs/aboutonc-health-it-certification-program.
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as optional transactions which health IT
developers may support in their
products (85 FR 25678). However, the
Certification Program does not yet
address electronic prior authorization
for other items and services that
healthcare consumers may seek to
obtain. Accordingly, for the purposes of
this RFI, we are interested in certified
health IT functions not yet included
under the Certification Program that can
support electronic prior authorization
processes for items and services other
than medications.
In the 21st Century Cures Act final
rule, ONC also finalized a new
certification criterion at
§ 170.315(g)(10), ‘‘standardized API for
patient and population services,’’ to
support the availability of secure,
standards-based application
programming interfaces (APIs) in
certified health IT products. This
criterion requires the use of FHIR
Release 4.0.1 and several
implementation specifications (85 FR
25742). Under the API Maintenance of
Certification Requirement for the ONC
Health IT Certification Program at
§ 170.404(b)(3), Certified API
Developers (as defined in § 170.404(c))
with API technology previously
certified to the criterion in
§ 170.315(g)(8) must provide API
technology certified to § 170.315(g)(10)
to all API Information Sources (as
defined in § 170.404(c)) deployed with
certified API technology no later than
December 31, 2022 (85 FR 70072). As
discussed in the 21st Century Cures Act
final rule, we believe the availability of
standards-based API functionality in
provider EHR systems is an important
step towards increased interoperability
across the healthcare system (85 FR
25740). While the initial use case for
this criterion has focused on patients’
access to their health information, we
believe this functionality can support a
wide range of use cases including
research, public health, quality
measurement, and healthcare
operations, including prior
authorization processes.
b. Requirements Under HIPAA for
Electronic Prior Authorization
Transaction Standards
Pursuant to the Health Insurance
Portability and Accountability Act of
1996 (HIPAA), the Secretary must adopt
electronic standards for use by ‘‘covered
entities,’’ which is defined as including
health plans, healthcare clearinghouses,
and certain healthcare providers. The
two standards adopted for referral
certification and authorization
transactions under HIPAA (§ 162.1302)
include: NCPDP Version D.0 for retail
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pharmacy drugs; and X12 Version
5010x217 278 (X12 278) for dental,
professional, and institutional request
for review and response for items and
services. The X12 275 standard, which
is used to transmit additional
documentation to health plans, is not
currently mandated under HIPAA, but it
may be used to support the exchange of
the additional information that is
required for prior authorization. Though
payers are required to accept the X12
278 standard for electronic prior
authorization transactions when
transmitted by a provider, and providers
have been encouraged to conduct the
transaction electronically, an annual
survey conducted by the Council for
Affordable Quality Healthcare has found
that the prior authorization transaction
standard, and electronic prior
authorizations in general, have not been
widely used.4
HIPAA also requires that HHS adopt
operating rules for the HIPAA standard
transactions. Operating rules are defined
at § 162.103 as the ‘‘necessary business
rules and guidelines for the electronic
exchange of information that are not
defined by a standard or its
implementation specifications as
adopted for purposes of HIPAA
Administrative Simplification.’’ The
National Committee on Vital and Health
Statistics (NCVHS) reviews the
operating rules developed by certain
entities and advises the Secretary as to
whether HHS should adopt them
(section 1173(g)(3) of the Social Security
Act). The Secretary adopts operating
rules by expedited rulemaking in
accordance with section 1173(g)(4) of
the Social Security Act. To date, HHS
has adopted operating rules for three
HIPAA transactions: Eligibility for a
health plan, healthcare claim status (76
FR 40458), and healthcare electronic
funds transfers (EFT) and remittance
advice (77 FR 48008).5
c. Recent Efforts To Advance Electronic
Prior Authorization Processes
Several recent HHS efforts have
focused on concerns about prior
authorization, core technical and policy
barriers, and approaches to improve
prior authorization processes and
reduce burden.
The Health Information Technology
Advisory Committee (HITAC),
established under section 3002 of the
Public Health Service Act, has
addressed prior authorization on several
occasions. In October 2019, the HITAC
4 See https://www.caqh.org/sites/default/files/
explorations/index/2020-caqh-index.pdf.
5 For more information on operating rules, see
https://www.caqh.org/core/operating-rules.
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Federal Register / Vol. 87, No. 15 / Monday, January 24, 2022 / Proposed Rules
put forth recommendations establishing
Interoperability Standards Priority
Target Areas and identified a ‘‘need for
standards to support the integration of
prior authorization into all applicable
EHR-based ordering workflows.’’ 6 In
2020, ONC charged the HITAC with
establishing the Intersection of Clinical
and Administrative Data (ICAD) Task
Force in order to produce information
and recommendations on the merging of
clinical and administrative data. The
ICAD Task Force, which included
members of the HITAC and NCVHS,
industry stakeholders, and the public,
explored a wide range of topics,
including transport and exchange
structures; areas for clinical and
operations data alignment; and privacy
and security rules and protections.
The ICAD Task Force’s final
recommendations 7 to the HITAC
included a recommendation to
‘‘Establish Standards for Prior
Authorization Workflows.’’ Specifically,
the final report recommended that ONC
work with CMS, other federal actors,
and standards development
organizations to ‘‘develop programmatic
. . . specifications to create an
authorization . . . such that the
authorization and related
documentation can be triggered in the
relevant workflow system where the
triggering event for the authorization is
created.’’ The Task Force emphasized
that a future standards ecosystem for
prior authorization should ‘‘allow for
standards development and evolution,
so as to not preclude innovation, while
including a ‘floor’ of standards to
promote rapid adoption through
common implementation.’’ This
approach can enable broad participation
among stakeholders while avoiding
unnecessary barriers for those who wish
to innovate. It can also provide for rapid
innovation and piloting, testing, and
validation of new tools and standards to
meet evolving needs. The final report
also provided an overview of existing
and emerging standards available to
support prior authorization workflows.
This included discussion of several
HL7® FHIR® Implementation Guides
(IGs) for exchange of prior authorization
information, including the HL7® FHIR®
Da Vinci Coverage Requirements
Discovery (CRD), Documentation
Templates and Coverage Rules (DTR),
and Prior Authorization Support (PAS)
6 HITAC recommendations on priority target
areas, October 16, 2019: https://www.healthit.gov/
sites/default/files/page/2019-12/2019-10-16_ISP_
TF_Final_Report_signed_508.pdf.
7 Final Recommendations of the ICAD Task Force,
November 2020: https://www.healthit.gov/sites/
default/files/facas/ICAD_TF_FINAL_Report_
HITAC_2020-11-06_0.pdf.
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IGs, which are discussed in more detail
below.
In December 2020, the Centers for
Medicare & Medicaid Services (CMS)
released a notice of proposed
rulemaking titled ‘‘Reducing Provider
and Patient Burden by Improving Prior
Authorization Processes, and Promoting
Patients’ Electronic Access to Health
Information for Medicaid Managed Care
Plans, State Medicaid Agencies, CHIP
Agencies and CHIP Managed Care
Entities, and Issuers of Qualified Health
Plans on the Federally Facilitated
Exchanges’’ (85 FR 82586, hereafter the
Interoperability and Prior Authorization
proposed rule). In that proposed rule,
CMS proposed to require Medicaid
Managed Care Plans, State Medicaid
Agencies, Children’s Health Insurance
Program (CHIP) Agencies and CHIP
Managed Care Entities, and Issuers of
Qualified Health Plans on the FederallyFacilitated Exchanges (impacted
payers), to establish standards-based
APIs to streamline the process of
submitting prior authorization requests
and reduce burden on both providers
and payers. Specifically, CMS proposed
to require impacted payers to
implement and maintain: (i) A
Documentation Requirement Lookup
Service API to enable providers to
determine which items and services
need a prior authorization and what
documentation is needed to submit the
prior authorization request (85 FR
82608); and (ii) a Prior Authorization
Support API to facilitate transmission of
prior authorization requests and
decisions while maintaining alignment
with, and facilitating the use of, HIPAA
transaction standards (85 FR 82609).
In the same notice of proposed
rulemaking, ONC issued the ‘‘Health
Information Technology Standards and
Implementation Specifications’’
proposed rulemaking (85 FR 82632;
hereafter the ONC Healthcare
Operations Standards proposed rule), in
which ONC proposed to adopt the
implementation specifications
referenced in CMS’ proposals (85 FR
82632–33), including the HL7® FHIR®
CRD, DTR, and PAS IGs supporting the
two API proposals related to prior
authorization. ONC proposed these
specifications for adoption by HHS as
part of a nationwide health IT
infrastructure supporting burden
reduction, healthcare cost reduction,
and improved care quality.
As part of the Interoperability and
Prior Authorization proposed rule, CMS
did not propose to require providers to
interact with the proposed payer APIs to
conduct prior authorization activities.
Instead, CMS stated its belief that
providers would adopt the technology
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and workflows needed to take advantage
of these APIs on a voluntary basis over
time, following updates by health IT
developers to electronic health record
systems and related tools. CMS
requested comment on additional ways
to encourage implementation of these
functions in EHRs, including the
adoption of certification criteria in the
ONC Health IT Certification Program (85
FR 82610). In response to this request
for comment, many stakeholders
expressed support for HHS advancing
EHR functionality to enable seamless
exchange of information facilitating
prior authorization.
While CMS continues to consider the
proposals put forth in the
Interoperability and Prior Authorization
proposed rule and public comments
received thereon, we believe there are
additional steps which HHS could
explore to improve electronic prior
authorization capabilities within health
IT systems. Based on stakeholder input,
including the recommendations of the
ICAD Task Force, we also believe there
is strong support across healthcare
industry stakeholders for additional
action.
d. Functional Capabilities for Electronic
Prior Authorization in Certified Health
IT
We are seeking comment on
functional capabilities for electronic
prior authorization that should be
considered for inclusion in certified
health IT. Specifically we are seeking
comment on a core set of capabilities
that would enable a certified Health IT
Module or Modules to:
• Identify when prior authorization is
applicable for an item or service, using
clinical decision support and/or user
input, and for receiving notifications of
changes in such applicability;
• Query a payer API for prior
authorization requirements for each
item and service and identify in real
time specific rules and documentation
requirements;
• Collect clinical and administrative
documentation needed to complete
prior authorization documentation
(electronic forms or templates) from a
health IT system;
• Electronically submit completed
documentation for prior authorization to
a payer’s API, along with supporting
information;
• Receive a response from a payer
regarding approval, denial (including a
reason for denial), or need for additional
information;
• Query a payer’s system for updates
on a pending prior authorization request
and have a reason returned as to why a
request is still pending; and
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• Effectively capture and persist
digital signatures (or other indications
of provider review and assent), enable
data integrity of documentation over
time, and support other features
necessary to meet payer administrative
requirements associated with prior
authorization transactions.
We invite further comment on
whether these are the appropriate
minimum capabilities needed for
certified health IT systems to
successfully interact with payer systems
to complete key electronic prior
authorization activities.
e. Implementation Specifications To
Support Electronic Prior Authorization
Capabilities
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As noted above, in the ONC
Healthcare Operations Standards
proposed rule ONC proposed to adopt,
on behalf of HHS, three implementation
specifications relevant to electronic
prior authorization (85 FR 82632):
• HL7® FHIR® Da Vinci Coverage
Requirements Discovery (CRD)
Implementation Guide.8
• HL7® FHIR® Da Vinci
Documentation Templates and Coverage
Rules (DTR) Implementation Guide.9
• HL7® FHIR® Da Vinci Prior
Authorization Support (PAS)
Implementation Guide.10
These IGs were developed by the Da
Vinci project, an initiative established
in 2018 to help payers and providers
positively impact clinical, quality, cost,
and care management outcomes.11 The
Da Vinci project is part of the HL7®
FHIR® Accelerator Program.12 Under
the Da Vinci project, industry
stakeholders have facilitated the
definition, design, and creation of usecase-specific implementation
documentation and supporting
materials based upon the HL7® FHIR®
standard in order to address value-based
care initiatives. Because the Da Vinci
project is aligned with HL7® and its
consensus-based approach to standards
development, new and revised
standards are easily and freely available
for public use. While ONC proposed to
adopt these IGs in the ONC Healthcare
Operations Standards proposed rule in
tandem with the proposed requirements
for payers in the CMS Interoperability
8 For more information, see https://www.hl7.org/
fhir/us/davinci-crd/.
9 For more information, see https://hl7.org/fhir/us/
davinci-dtr/.
10 For more information, see https://hl7.org/fhir/
us/davinci-pas/.
11 For more information, see https://www.hl7.org/
about/davinci/.
12 For more information, see https://www.hl7.org/
documentcenter/public/pressreleases/HL7_PRESS_
20190211.pdf.
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and Prior Authorization proposed rule
(85 FR 82632), we are now seeking to
understand the appropriateness of using
these IGs to support functionality
within certified health IT systems used
by healthcare providers and other
stakeholders.
Below we offer a description of each
IG and a discussion of key issues to help
the public provide input.
Da Vinci Coverage Requirements
Discovery (CRD) Implementation Guide
The purpose of this IG is to define a
workflow whereby clinical IT systems
can query coverage requirements from
payer IT systems at the time treatment
decisions are made. This ensures that
clinicians and administrative staff can
make informed decisions and meet the
requirements of the patient’s insurance
coverage. Different insurance products
may have varying requirements for prior
authorization documentation. Providers
who fail to adhere to payer requirements
may not receive payer coverage for care
provided or may cause a delay in
needed care, which may result in
increased out of pocket costs for
patients, potential additional visits and
changes in the preferred care plan,
health risks for the patient, and
increased burden for all parties
involved.
This IG utilizes the Clinical Decision
Support (CDS) Hooks specification 13 in
order to: Establish triggers for querying
payers for coverage requirements; define
how payers publish services describing
coverage requirements; define how
clinical systems query payers for
coverage requirements; and define how
clinical systems present coverage
requirements to users for clinical
decision support. The CRD IG allows
provider IT systems to query payer IT
systems via CDS Hooks to determine if
there are documentation requirements
for a proposed medication, procedure,
or other service. When a provider
triggers a prior authorization-related
CDS Hook within their IT system
indicating that payer documentation
requirements exist for a product or
service, a CDS Hooks Card(s) is returned
with information about the
documentation requirements and
options to read, accept a suggestion, or
interact with an app to address those
requirements.
The CRD IG extends the CDS Hooks
specification to define additional hook
resources, a hook configuration
mechanism, additional prefetch
capabilities, and additional response
capabilities. In addition to the reliance
13 For
more information, see https://cdshooks.hl7.org/.
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of this IG on the nascent CDS Hooks
specification, these extensions may
change in the future, depending on how
they are incorporated into the CDS
Hooks specification, which may cause
compatibility issues with future
versions of the CRD IG.
The information that may be shared
using this IG includes:
• Updated coverage information.
• Alternative preferred/first-line/
lower-cost services/products.
• Documents, rules, forms, templates,
and links to resources related to
coverage.
• Updated clinical information for
decision support.
• Indications of whether prior
authorization is required.
Documentation Templates and Coverage
Rules (DTR) Implementation Guide
The purpose of the DTR IG is to
ensure the completion of documentation
needed to demonstrate medical
necessity for a proposed medication,
procedure, or other service. This IG
specifies how payer coverage rules can
be executed in a provider context to
ensure that documentation requirements
are met. A companion to the CRD IG,
the DTR IG leverages the ability of CDS
Hooks Cards to link to Substitutable
Medical Applications, Reusable
Technologies (SMART) on FHIR 14 apps
to launch and execute payer rules. The
DTR IG describes the interactions
between a SMART on FHIR app and the
payer’s IT system to retrieve the payer’s
documentation requirements, in the
form of Clinical Quality Language
(CQL) 15 and a FHIR Questionnaire
resource, for use by the provider and the
provider’s IT system. The provider’s IT
system communicates with the payer’s
IT system, which informs the provider’s
system of the documentation that needs
to be completed using the CQL logic and
the FHIR Questionnaire resource. To
populate the FHIR
QuestionnaireResponse, which are the
results of the FHIR Questionnaire
resource, the IG describes a process
where the provider’s IT system autopopulates as many fields as possible,
then alerts the provider to any
information gaps, which the provider
can complete manually. The IG
describes that all relevant information
from these transactions is stored in the
provider’s IT system for future use,
including to support subsequently
providing the FHIR
QuestionnaireResponse to the payer as
14 For more information, see https://
docs.smarthealthit.org/
15 For more information, see https://cql.hl7.org/
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part of documentation for prior
authorization.
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Da Vinci Prior Authorization Support
(PAS) Implementation Guide
The PAS IG uses the FHIR standard as
the basis for (i) assembling the
information necessary to substantiate
clinical need for a particular treatment;
and (ii) submitting the assembled
information and prior authorization
request to an intermediary before
transmission to the intended recipient.
Under the workflow specified in the
PAS IG, to meet regulatory requirements
for HIPAA standard transactions
discussed above, the FHIR interface
communicates with an intermediary
functionality (such as a clearinghouse)
that converts the FHIR requests to a
HIPAA compliant X12 278 request
transaction for submission to the payer.
In some cases, the payer itself, if acting
as the intermediary or clearinghouse,
may convert the request to a HIPAA
compliant X12 278 transaction. Under
the workflow specified in the PAS IG,
the response from the payer would then
flow back through the intermediary
functionality using X12 and would be
made available to the provider’s health
IT system using the FHIR standard. The
response would indicate whether the
payer approves (and for how long),
denies (with a reason for denial), or
requests more information about the
prior authorization request. This IG also
defines capabilities around the
management of prior authorization
requests, including checking on the
status of a previously submitted request,
revising a previously submitted request,
and cancelling a request.
Discussion
Based on public input to date,
including comments received on the
CMS Interoperability and Prior
Authorization and ONC Healthcare
Operations Standards proposed rules in
December 2020, and our own review,
we have identified a number of issues
that may be relevant to the use of these
IGs in certified health IT. These include
concerns that the IGs lack maturity and
have not yet undergone extensive
testing in production and rely on other
IGs and features in FHIR that are
immature. In some cases, the available
versions of the IGs propose changes and
pre-adopt changes to dependent IGs, or
request feedback on design
considerations within the IGs that may
impact compatibility between these
versions and future versions. Additional
issues regarding the PAS IG include
concerns around the translation from
FHIR to X12 included as part of the
specification. While enabling
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compliance with existing regulatory
requirements, the translation approach
may increase the number of transactions
necessary for exchange as well as
dependency on intermediaries. Issues
regarding the DTR and CRD IGs include
concerns that the detailed workflow
described in the specification leverages
CDS Hooks functionality, which has not
yet been adopted in any certification
criterion under the Certification
Program. We welcome additional
information about these IGs, especially
given that a year has passed since we
last heard from the public on this topic
as part of the ONC Healthcare
Operations Standards proposed rule.
f. Additional Approaches To Support
Electronic Prior Authorization:
Healthcare Attachments
The implementation specifications
described above represent important
standards development collaborations
between industry stakeholders. We
believe these activities may present an
important pathway to streamlining
electronic prior authorization processes,
as reflected in our proposal in the ONC
Healthcare Operations Standards
proposed rule. However, we understand
that there are capabilities and standards
currently supported by certified health
IT products that may facilitate certain
elements of prior authorization
workflows. For instance, electronic
exchange of healthcare attachments can
be used to transmit clinical information
in conjunction with an electronic
administrative transaction to meet
health plan requirements. ONC is aware
of several standards initiatives within
the last five years focused on advancing
standards and functionality supporting
clinical documents for a broad range of
use cases, including for attachments
within prior authorization and other
administrative workflows.
These initiatives include the HL7
implementation guide based on the
Consolidated Clinical Document
Architecture (C–CDA) Release, and HL7
FHIR Documents:
• HL7 C–CDA R2 Attachment
Implementation Guide: Exchange of C–
CDA Based Documents, Release 1.16
• HL7 FHIR Release 4, Section 3.3:
FHIR Documents.17
The HL7 C–CDA R2 Attachment
Implementation Guide (CDA
Attachments IG) defines the
requirements for sending and receiving
standards-based electronic attachments
and incorporates certain administrative
16 For more information, see https://www.hl7.org/
documentcenter/public/standards/dstu/CDAR2_
AIG_CCDA_EXCHANGE_R1_STU_2017AUG.pdf.
17 For more information, see https://www.hl7.org/
fhir/documents.html.
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information into the document header.
The C–CDA document templates are
designed to be electronic versions of the
most common types of paper document
attachment information. ONC has
adopted the C–CDA standard for use in
the Certification Program in § 170.205.
An HL7 FHIR Release 4 FHIR
Document (FHIR Documents) is a set of
healthcare-related information that is
assembled into a single package that
provides a coherent statement,
establishes its own context, and
includes attribution with regard to who
is making the statement. The FHIR
Documents section of the base FHIR
Release 4 standard (adopted by ONC in
§ 170.215) specifies how FHIR resources
can be used to build documents that
represent a statement of healthcare
information, including representing
clinical observations and services as a
cohesive composition. The resulting
document is an immutable set of
resources with a fixed presentation that
can be used for a wide range of use
cases, including administrative
transactions.
Discussion
Healthcare and health IT stakeholders
have called for a standardized approach
to electronic healthcare attachments,
while emphasizing that solutions
should align with advances in
interoperability and that HHS policy
should allow for innovation (for
example, see public comments received
by the HITAC in 2019,18 the NCVHS in
2018,19 2020,20 and 2021,21 and the
joint ICAD taskforce in 2020). Because
of the ongoing advancement of health IT
standards and functionality supporting
clinical and care coordination
workflows, there are several options
available for interoperable exchange
today, including both document-based
exchange using the C–CDA base
standard and exchange using
standardized APIs using the FHIR base
standard. This increase in interoperable
options can support the combination of
clinical and administrative data and
allow for more timely and effective
18 See https://www.healthit.gov/sites/default/
files/facas/2019-03-20_HITAC_Meeting_Notes.pdf.
19 See https://ncvhs.hhs.gov/transcripts-minutes/
transcript-standards-subcommittee-predictabilityroadmap-hearing-day-one-december-12-2018/ and
https://ncvhs.hhs.gov/transcripts-minutes/
transcript-standards-subcommittee-predictabilityroadmap-hearing-day-two-december-13-2018/.
20 See https://ncvhs.hhs.gov/wp-content/uploads/
2020/10/Public-Comments-CAQH-CORE-OperatingRules-for-Federal-Adoption-August-2020r.pdf.
21 See https://ncvhs.hhs.gov/wp-content/uploads/
2021/08/Public-Comments-StandardsSubcommittee-Listening-Session-August-252021.pdf.
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approvals of prior authorization
requests.
We understand that stakeholders may
also have concerns with these potential
approaches, for instance, concerns
related to lack of testing and production
implementation of these approaches
that are specific to the prior
authorization use case, despite
widespread use of the underlying
standards for other purposes. Regarding
the underlying standards for each
approach, we understand that while the
C–CDA has the benefit of being in
widespread use, the more inflexible
nature of the standard may increase the
ongoing burden of maintenance and
updates to the standard over time. FHIR
solutions offer a more flexible and agile
option over time, but there may be
additional development and
specification needed for their effective
implementation. We welcome
additional information about these
standards and implementation
specifications for this part of the prior
authorization workflow.
We also welcome further information
on any other additional areas we should
consider in supporting the exchange of
healthcare attachments in prior
authorization workflows. For example,
we understand there is also ongoing
work to create a FHIR-based IG for
healthcare attachments.22 In addition,
while the scope of this RFI is focused on
prior authorization processes, we
recognize that the systems used for this
purpose may also support a wide range
of administrative transactions and
operations workflows and that
healthcare attachments are used for
other administrative and operations
purposes such as claims processing. In
the same way that aligned standards
between administrative systems and
clinical systems can optimize
effectiveness, aligned standards across
administrative use cases may also
support efficiency. We therefore
welcome public comment on the
potential intersection with other
administrative and operations processes
that we should consider when exploring
options for healthcare attachments, as
well as comments on how to best
harmonize these efforts. Finally, we
welcome public comment on other
standards initiatives, pilot projects, or
health IT resources that we should
explore to identify promising best
practices, emerging standards, or
innovative approaches to advance
interoperable health IT for healthcare
operations use cases.
22 For more information, see https://build.fhir.org/
ig/HL7/davinci-ecdx/.
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II. Request for Comments
ONC seeks public comments on
whether to adopt additional standards,
implementation specifications, and
certification criteria as part of the
Certification Program to ensure that
technology is available to providers for
the automated, electronic completion of
prior authorization tasks. In addition to
general comments on the issues
presented above, we are seeking input
on the following questions:
Certified Health IT Functionality
• Do the functional capabilities
described above include all necessary
functionality for certified Health IT
Modules to successfully facilitate
electronic prior authorization processes?
Are there additional capabilities that
should be included in certified Health
IT Modules to address these needs?
Should any of these functional
capabilities not be included in certified
Health IT Modules (please cite the
reason they should be excluded) or
should ONC focus on a more limited set
of functional capabilities for certified
Health IT Modules than those described
above?
• Should ONC adopt a certification
criterion for prior authorization that
accounts for the full, HIPAA compliant
workflow for prior authorization
transactions including translation from
FHIR to the X12 standard? Or should
ONC adopt certification criteria that
include only the workflows up to the
point of translation? What ongoing
challenges will stakeholders face if there
is a need to translate between HIPAAadopted standards and other standards
that have only been adopted under the
Certification Program used to support
prior authorization transactions? How
should HHS address alignment between
standards adopted for HIPAA
transactions and standards adopted
under the Certification Program?
• If ONC were to propose to include
these functional capabilities as part of
the Certification Program, how should a
new certification criterion (or multiple
certification criteria) be structured,
including technical requirements,
attributed standards, and
implementation specifications? ONC’s
experience adopting certification
criteria suggests that, at times,
combining related functions into a
single Health IT Module is most
appropriate, while in other cases, health
IT functionalities are best represented
by separate certification criteria, despite
being functionally related. For instance,
under a single criterion, different
products and services in the market may
be ‘‘tightly coupled’’ for the purposes of
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certification, even when they can be
purchased and implemented separately.
We seek the public’s input on which
functional capabilities for prior
authorization should be tested and
certified together as part of one
certification criterion, and which
capabilities should be separated into
different certification criteria.
Implementation Specifications for Prior
Authorization
• What is the current readiness of the
three FHIR-based Da Vinci IGs
described above for adoption as part of
certification criteria for health IT? Given
limited testing of these specifications to
date, what would be a feasible timeline
for use of these IGs in production for
prior authorization transactions? What,
if any, additional changes are needed for
these IGs prior to adoption as part of
certification criteria for health IT?
• If the existing IGs are not yet ready
for adoption, should ONC still propose
certification criteria? Should ONC
consider proposing certification criteria
incorporating the FHIR Release 4 base
standard but delay adopting
implementation specifications until a
later date? What are the potential risks
of this approach?
• If we were to adopt certification
criteria referencing the base standard
and then update those criteria to
integrate implementation specifications
in the future, how should these
integrations be handled? When and how
should the existing systems be replaced?
All at once, or as a series of transitional
steps?
• Do the Da Vinci IGs effectively
support Federal and state legal
requirements and/or health plan
compliance requirements for clinical
documentation, for example, signatures
(or other indications of provider review
and assent), record retention over long
periods of time, and document security
to ensure data integrity once stored?
• What alternative approaches to
designing certification criteria should
ONC explore that are not based on the
three Da Vinci IGs described herein?
• Are there simplified approaches to
the workflows described in the Da Vinci
IGs that ONC should consider as
alternative approaches to support
electronic prior authorization?
• Are there new IGs which need to be
developed in order to integrate with
other workflows relevant to prior
authorization? In particular, what IGs
may still need to be developed in order
to integrate with HIPAA administrative
transaction standards?
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Healthcare Attachment Standards
• Would the specifications within the
CDA Attachments IG, if adopted as part
of a certification criterion, support more
effective exchange of healthcare
attachments for prior authorization?
Would any changes to the IG be needed,
or would additional functionalities or
standards be required for effective
implementation of the CDA
Attachments IG in certified health IT?
• Would the use of FHIR Documents,
if adopted as part of a certification
criterion, support more effective
exchange of healthcare attachments?
Are there any gaps or constraints that
would need to be further specified, such
as through an IG, in order for FHIR
Documents to be effective for this use
case when implemented in certified
health IT? Would the adoption of a
certification criterion for FHIR
Documents support other administrative
use cases beyond prior authorization?
• Given limited testing of these
approaches to date, what would be a
feasible timeline for use of the CDA
Attachments IG or FHIR Documents in
production for prior authorization
transactions?
• Which of these approaches would
better accommodate improvements over
time to meet payer and provider needs?
Should ONC consider adopting
certification criteria referencing one
approach over the other, or should ONC
consider supporting both approaches
within certified health IT?
• If the IGs developed by the Da Vinci
Project, or an alternate set of IGs
addressing the full scope of prior
authorization workflows, are not yet
ready for adoption in certified health IT,
should ONC propose certification
criteria to support healthcare
attachments transactions for prior
authorization alone?
• Healthcare attachments are used for
a wide range of operations and
administrative workflows beyond prior
authorization. Are either of the
standards discussed above commonly
used in other administrative or
operations transactions? Would there be
a burden or benefit to using either, or
both, standards in light of other
administrative or operations workflows?
Are there additional standards or
implementation specifications ONC
should consider that are in common use
for healthcare attachments used in other
administrative or operations workflows?
Impact on Patients
• How could potential changes to the
Certification Program to better support
prior authorization positively impact
healthcare consumers?
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• How could potential changes
reduce the time for patients to receive
needed healthcare services, reduce
patient non-adherence, and/or lower
out-of-pocket costs?
• Besides the provider to payer
interactions discussed in this RFI, is
there additional functionality that could
be added to the Certification Program
that would better support patients’
participation in the prior authorization
process?
Impact on Providers
• To what degree is availability of
electronic prior authorization
capabilities within certified health IT
likely to reduce burden for healthcare
providers who currently engage in prior
authorization activities?
• To what degree are healthcare
providers likely to use these new
capabilities across their patient panels?
Will additional incentives or
requirements be needed to ensure
healthcare providers effectively use
these capabilities? What accompanying
documentation or support would be
needed to ensure that technology
capabilities are implemented in ways
that effectively improve clinical
workflows?
• What estimates can providers share
about the cost and time (in hours)
associated with adopting and
implementing electronic prior
authorization functionality as part of
care delivery processes?
Impact on Developers
• What estimates can health IT
developers share about the cost and
time (in hours) of developing electronic
prior authorization functionality within
certified health IT products?
• What factors would inform the
burden for health IT developers to
develop certified Health IT Modules for
electronic prior authorization based on
the three Da Vinci IGs described above?
• What would be the burden on
health IT developers for prior
authorization certification criteria
referencing the base FHIR standard if
there were not yet specific IGs adopted
as well? How would potentially moving
to criteria with use case specific IGs
over time impact development burden?
Would such a staged approach be
detrimental or beneficial to the longterm development timeline and burden
for health IT developers seeking to
support electronic prior authorization?
Payer Implementation
• How could the Certification
Program support the technology needs
of healthcare payers in implementing
electronic prior authorization? Should
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3481
ONC consider payer workflows in the
development of certification criteria to
support the potential use of certified
Health IT Modules by healthcare
payers? Would the availability of
certified Health IT Modules supporting
these workflows reduce the burden for
healthcare payers of engaging with
healthcare providers in prior
authorization processes?
• To what extent would healthcare
payers be likely to use these certified
Health IT Modules if they were
available? To what extent are health IT
developers likely to seek certification
for Health IT Modules supporting payer
workflows if these certification criteria
were available?
Dated: January 19, 2022.
Xavier Becerra,
Secretary, Department of Health and Human
Services.
[FR Doc. 2022–01309 Filed 1–21–22; 8:45 am]
BILLING CODE 4150–45–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 25
[IB Docket No. 21–456; RM–11855; FCC 21–
123; FR ID 66659]
Spectrum Sharing Rules for NonGeostationary Orbit, Fixed-Satellite
Service Systems
Federal Communications
Commission.
ACTION: Proposed rule.
AGENCY:
The Federal Communications
Commission (FCC or Commission)
proposes to revise its rules governing
spectrum sharing among nongeostationary satellite orbit, fixedsatellite service (NGSO FSS) systems.
The FCC proposes that its existing
spectrum sharing mechanism for NGSO
FSS systems will be limited to those
systems approved in the same
processing round. The FCC also
proposes to adopt a rule providing that
later-round NGSO FSS systems will
have to protect earlier-round systems,
and invites comment on how to define
such protection. In addition, the FCC
seeks comment on whether to sunset,
after a period of time, the interference
protection afforded to an NGSO FSS
system because of its processing round
status.
DATES: Comments are due on or before
March 25, 2022; reply comments are
due on or before April 25, 2022.
ADDRESSES: You may submit comments,
identified by IB Docket No. 21–456, by
any of the following methods:
SUMMARY:
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Agencies
[Federal Register Volume 87, Number 15 (Monday, January 24, 2022)]
[Proposed Rules]
[Pages 3475-3481]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01309]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
45 CFR Part 170
RIN-0955-AA04
Request for Information: Electronic Prior Authorization
Standards, Implementation Specifications, and Certification Criteria
AGENCY: Office of the National Coordinator for Health IT, Health and
Human Services (HHS).
ACTION: Request for information
-----------------------------------------------------------------------
SUMMARY: This request for information seeks input from the public
regarding electronic prior authorization standards, implementation
specifications, and certification criteria that could be adopted within
the ONC Health IT Certification Program. Responses to this Request for
Information will be used to inform potential future rulemaking.
DATES: To be assured consideration, written or electronic comments must
be received at one of the addresses provided below, no later than 5
p.m. on March 25, 2022.
ADDRESSES: You may submit comments, identified by RIN 0955-AA04, by any
of the following methods (please do not submit duplicate comments).
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
Federal eRulemaking Portal: Follow the instructions for submitting
comments. Attachments should be in Microsoft Word, Microsoft Excel, or
Adobe PDF; however, we prefer Microsoft Word. https://www.regulations.gov.
Regular, Express, or Overnight Mail: Department of Health and Human
Services, Office of the National Coordinator for Health Information
Technology, Attention: Request for Information: Electronic Prior
Authorization Standards, Implementation Specifications, and
Certification Criteria, Mary E. Switzer Building, Mail Stop: 7033A, 330
C Street SW, Washington, DC 20201. Please submit one original and two
copies.
Hand Delivery or Courier: Office of the National Coordinator for
Health Information Technology, Attention: Request for Information:
Electronic Prior Authorization Standards, Implementation
Specifications, and Certification Criteria, Mary E. Switzer Building,
Mail Stop: 7033A, 330 C Street SW, Washington, DC 20201. Please submit
one original and two copies. (Because access to the interior of the
Mary E. Switzer Building is not readily available to persons without
Federal Government identification, commenters are encouraged to leave
their comments in the mail drop slots located in the main lobby of the
building.)
Inspection of Public Comments: All comments received before the
close of the comment period will be available for public inspection,
including any personally identifiable or confidential business
information that is included in a comment. Please do not include
anything in your comment submission that you do not wish to share with
the general public. Such information includes, but is not limited to: A
person's social security number; date of birth; driver's license
number; state identification number or foreign country equivalent;
passport number; financial account number; credit or debit card number;
any personal health information; or any business information that could
be considered proprietary. We will post all comments that are received
before the close of the comment period at https://www.regulations.gov.
Docket: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov or the Department
of Health and Human Services, Office of the National Coordinator for
Health Information Technology, Mary E. Switzer Building, Mail Stop:
7033A, 330 C Street SW, Washington, DC 20201 (call ahead to the contact
listed below to arrange for inspection).
FOR FURTHER INFORMATION CONTACT: Alex Baker, Office of Policy, Office
of the National Coordinator for Health Information Technology, 202-260-
2048.
SUPPLEMENTARY INFORMATION:
I. Background
For purposes of this Request for Information (RFI), prior
authorization generally refers to rules imposed by healthcare payers
that require approval for a medication, procedure, device, or other
medical service be obtained prior to payment for the item or service.
Prior authorization requirements are established by payers to help
control costs and ensure payment accuracy by verifying that an item or
service is medically necessary, meets coverage criteria, and is
consistent with standards of care. Stakeholders have stated that
diverse payer policies, provider workflow challenges, and technical
barriers create an environment in which the prior authorization process
is a source of burden for patients, providers, and payers; a cause of
burnout for providers; and a health risk for patients when it delays
their care.\1\
---------------------------------------------------------------------------
\1\ For additional discussion of administrative burden
associated with the prior authorization process, see the CMS
Interoperability and Prior Authorization proposed rule at 85 FR
82606.
---------------------------------------------------------------------------
ONC's Strategy on Reducing Regulatory and Administrative Burden
Relating to the Use of Health IT and EHRs,\2\ released in 2020,
identified challenges associated with the prior authorization process,
including: (i) Difficulty in determining whether an item or service
requires prior authorization; (ii) difficulty in determining payer-
specific prior authorization requirements for those items and services;
(iii) inefficient use of provider and staff time to navigate
communications channels such as fax, telephone, and various web
portals; and
[[Page 3476]]
(iv) unpredictable and lengthy amounts of time to receive payer
decisions. The Strategy notes that payers and health IT developers have
addressed prior authorization in an ad hoc manner with interfaces that
reflect individual payer technology considerations, payer lines of
business, and customer-specific constraints. In order to address these
issues, the Strategy included a number of recommendations to strengthen
electronic prior authorization processes, such as: Leveraging health IT
to standardize data and processes around ordering services or
equipment; coordinating efforts to advance new standards approaches;
and incentivizing adoption and/or use of technology that can generate
and exchange standardized data to support documentation needs.
---------------------------------------------------------------------------
\2\ Office of the National Coordinator for Health Information
Technology. Strategy on Reducing Regulatory and Administrative
Burden Relating to the Use of Health IT and EHRs [PDF file].
February 2020. Retrieved from https://www.healthit.gov/sites/default/files/page/2020-02/BurdenReport_0.pdf.
---------------------------------------------------------------------------
In order to further explore these and other stakeholder
recommendations, and to build on recent efforts related to electronic
prior authorization, we seek public comments on how the ONC Health IT
Certification Program (Certification Program) could incorporate
standards, implementation specifications, and certification criteria to
advance electronic prior authorization.
a. ONC Health IT Certification Program
The Certification Program \3\ is a voluntary program under which
health IT developers can obtain ONC certification for their health IT
products. Requirements for certification are established by standards,
implementation specifications, and certification criteria adopted
through rulemaking by the Secretary. The Certification Program does not
set any requirements for healthcare providers but supports the
availability of certified health IT for use by healthcare providers
under other federal, state, and private programs.
---------------------------------------------------------------------------
\3\ For more information, see https://www.healthit.gov/topic/certification-ehrs/about-onc-health-it-certification-program.
---------------------------------------------------------------------------
The Certification Program currently addresses electronic prior
authorization for medications as part of the ``electronic prescribing''
certification criterion at 45 CFR 170.315(b)(3). On May 1, 2020, ONC
published in the Federal Register the ``21st Century Cures Act:
Interoperability, Information Blocking, and the ONC Health IT
Certification Program'' final rule (21st Century Cures Act final rule).
In this rule, ONC adopted the National Council for Prescription Drug
Programs (NCPDP) SCRIPT Standard, Version 2017071, for electronic
prescribing and specified electronic prior authorization transactions
supported by the standard as optional transactions which health IT
developers may support in their products (85 FR 25678). However, the
Certification Program does not yet address electronic prior
authorization for other items and services that healthcare consumers
may seek to obtain. Accordingly, for the purposes of this RFI, we are
interested in certified health IT functions not yet included under the
Certification Program that can support electronic prior authorization
processes for items and services other than medications.
In the 21st Century Cures Act final rule, ONC also finalized a new
certification criterion at Sec. 170.315(g)(10), ``standardized API for
patient and population services,'' to support the availability of
secure, standards-based application programming interfaces (APIs) in
certified health IT products. This criterion requires the use of FHIR
Release 4.0.1 and several implementation specifications (85 FR 25742).
Under the API Maintenance of Certification Requirement for the ONC
Health IT Certification Program at Sec. 170.404(b)(3), Certified API
Developers (as defined in Sec. 170.404(c)) with API technology
previously certified to the criterion in Sec. 170.315(g)(8) must
provide API technology certified to Sec. 170.315(g)(10) to all API
Information Sources (as defined in Sec. 170.404(c)) deployed with
certified API technology no later than December 31, 2022 (85 FR 70072).
As discussed in the 21st Century Cures Act final rule, we believe the
availability of standards-based API functionality in provider EHR
systems is an important step towards increased interoperability across
the healthcare system (85 FR 25740). While the initial use case for
this criterion has focused on patients' access to their health
information, we believe this functionality can support a wide range of
use cases including research, public health, quality measurement, and
healthcare operations, including prior authorization processes.
b. Requirements Under HIPAA for Electronic Prior Authorization
Transaction Standards
Pursuant to the Health Insurance Portability and Accountability Act
of 1996 (HIPAA), the Secretary must adopt electronic standards for use
by ``covered entities,'' which is defined as including health plans,
healthcare clearinghouses, and certain healthcare providers. The two
standards adopted for referral certification and authorization
transactions under HIPAA (Sec. 162.1302) include: NCPDP Version D.0
for retail pharmacy drugs; and X12 Version 5010x217 278 (X12 278) for
dental, professional, and institutional request for review and response
for items and services. The X12 275 standard, which is used to transmit
additional documentation to health plans, is not currently mandated
under HIPAA, but it may be used to support the exchange of the
additional information that is required for prior authorization. Though
payers are required to accept the X12 278 standard for electronic prior
authorization transactions when transmitted by a provider, and
providers have been encouraged to conduct the transaction
electronically, an annual survey conducted by the Council for
Affordable Quality Healthcare has found that the prior authorization
transaction standard, and electronic prior authorizations in general,
have not been widely used.\4\
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\4\ See https://www.caqh.org/sites/default/files/explorations/index/2020-caqh-index.pdf.
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HIPAA also requires that HHS adopt operating rules for the HIPAA
standard transactions. Operating rules are defined at Sec. 162.103 as
the ``necessary business rules and guidelines for the electronic
exchange of information that are not defined by a standard or its
implementation specifications as adopted for purposes of HIPAA
Administrative Simplification.'' The National Committee on Vital and
Health Statistics (NCVHS) reviews the operating rules developed by
certain entities and advises the Secretary as to whether HHS should
adopt them (section 1173(g)(3) of the Social Security Act). The
Secretary adopts operating rules by expedited rulemaking in accordance
with section 1173(g)(4) of the Social Security Act. To date, HHS has
adopted operating rules for three HIPAA transactions: Eligibility for a
health plan, healthcare claim status (76 FR 40458), and healthcare
electronic funds transfers (EFT) and remittance advice (77 FR
48008).\5\
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\5\ For more information on operating rules, see https://www.caqh.org/core/operating-rules.
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c. Recent Efforts To Advance Electronic Prior Authorization Processes
Several recent HHS efforts have focused on concerns about prior
authorization, core technical and policy barriers, and approaches to
improve prior authorization processes and reduce burden.
The Health Information Technology Advisory Committee (HITAC),
established under section 3002 of the Public Health Service Act, has
addressed prior authorization on several occasions. In October 2019,
the HITAC
[[Page 3477]]
put forth recommendations establishing Interoperability Standards
Priority Target Areas and identified a ``need for standards to support
the integration of prior authorization into all applicable EHR-based
ordering workflows.'' \6\ In 2020, ONC charged the HITAC with
establishing the Intersection of Clinical and Administrative Data
(ICAD) Task Force in order to produce information and recommendations
on the merging of clinical and administrative data. The ICAD Task
Force, which included members of the HITAC and NCVHS, industry
stakeholders, and the public, explored a wide range of topics,
including transport and exchange structures; areas for clinical and
operations data alignment; and privacy and security rules and
protections.
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\6\ HITAC recommendations on priority target areas, October 16,
2019: https://www.healthit.gov/sites/default/files/page/2019-12/2019-10-16_ISP_TF_Final_Report_signed_508.pdf.
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The ICAD Task Force's final recommendations \7\ to the HITAC
included a recommendation to ``Establish Standards for Prior
Authorization Workflows.'' Specifically, the final report recommended
that ONC work with CMS, other federal actors, and standards development
organizations to ``develop programmatic . . . specifications to create
an authorization . . . such that the authorization and related
documentation can be triggered in the relevant workflow system where
the triggering event for the authorization is created.'' The Task Force
emphasized that a future standards ecosystem for prior authorization
should ``allow for standards development and evolution, so as to not
preclude innovation, while including a `floor' of standards to promote
rapid adoption through common implementation.'' This approach can
enable broad participation among stakeholders while avoiding
unnecessary barriers for those who wish to innovate. It can also
provide for rapid innovation and piloting, testing, and validation of
new tools and standards to meet evolving needs. The final report also
provided an overview of existing and emerging standards available to
support prior authorization workflows. This included discussion of
several HL7[supreg] FHIR[supreg] Implementation Guides (IGs) for
exchange of prior authorization information, including the HL7[supreg]
FHIR[supreg] Da Vinci Coverage Requirements Discovery (CRD),
Documentation Templates and Coverage Rules (DTR), and Prior
Authorization Support (PAS) IGs, which are discussed in more detail
below.
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\7\ Final Recommendations of the ICAD Task Force, November 2020:
https://www.healthit.gov/sites/default/files/facas/ICAD_TF_FINAL_Report_HITAC_2020-11-06_0.pdf.
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In December 2020, the Centers for Medicare & Medicaid Services
(CMS) released a notice of proposed rulemaking titled ``Reducing
Provider and Patient Burden by Improving Prior Authorization Processes,
and Promoting Patients' Electronic Access to Health Information for
Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and
CHIP Managed Care Entities, and Issuers of Qualified Health Plans on
the Federally Facilitated Exchanges'' (85 FR 82586, hereafter the
Interoperability and Prior Authorization proposed rule). In that
proposed rule, CMS proposed to require Medicaid Managed Care Plans,
State Medicaid Agencies, Children's Health Insurance Program (CHIP)
Agencies and CHIP Managed Care Entities, and Issuers of Qualified
Health Plans on the Federally-Facilitated Exchanges (impacted payers),
to establish standards-based APIs to streamline the process of
submitting prior authorization requests and reduce burden on both
providers and payers. Specifically, CMS proposed to require impacted
payers to implement and maintain: (i) A Documentation Requirement
Lookup Service API to enable providers to determine which items and
services need a prior authorization and what documentation is needed to
submit the prior authorization request (85 FR 82608); and (ii) a Prior
Authorization Support API to facilitate transmission of prior
authorization requests and decisions while maintaining alignment with,
and facilitating the use of, HIPAA transaction standards (85 FR 82609).
In the same notice of proposed rulemaking, ONC issued the ``Health
Information Technology Standards and Implementation Specifications''
proposed rulemaking (85 FR 82632; hereafter the ONC Healthcare
Operations Standards proposed rule), in which ONC proposed to adopt the
implementation specifications referenced in CMS' proposals (85 FR
82632-33), including the HL7[supreg] FHIR[supreg] CRD, DTR, and PAS IGs
supporting the two API proposals related to prior authorization. ONC
proposed these specifications for adoption by HHS as part of a
nationwide health IT infrastructure supporting burden reduction,
healthcare cost reduction, and improved care quality.
As part of the Interoperability and Prior Authorization proposed
rule, CMS did not propose to require providers to interact with the
proposed payer APIs to conduct prior authorization activities. Instead,
CMS stated its belief that providers would adopt the technology and
workflows needed to take advantage of these APIs on a voluntary basis
over time, following updates by health IT developers to electronic
health record systems and related tools. CMS requested comment on
additional ways to encourage implementation of these functions in EHRs,
including the adoption of certification criteria in the ONC Health IT
Certification Program (85 FR 82610). In response to this request for
comment, many stakeholders expressed support for HHS advancing EHR
functionality to enable seamless exchange of information facilitating
prior authorization.
While CMS continues to consider the proposals put forth in the
Interoperability and Prior Authorization proposed rule and public
comments received thereon, we believe there are additional steps which
HHS could explore to improve electronic prior authorization
capabilities within health IT systems. Based on stakeholder input,
including the recommendations of the ICAD Task Force, we also believe
there is strong support across healthcare industry stakeholders for
additional action.
d. Functional Capabilities for Electronic Prior Authorization in
Certified Health IT
We are seeking comment on functional capabilities for electronic
prior authorization that should be considered for inclusion in
certified health IT. Specifically we are seeking comment on a core set
of capabilities that would enable a certified Health IT Module or
Modules to:
Identify when prior authorization is applicable for an
item or service, using clinical decision support and/or user input, and
for receiving notifications of changes in such applicability;
Query a payer API for prior authorization requirements for
each item and service and identify in real time specific rules and
documentation requirements;
Collect clinical and administrative documentation needed
to complete prior authorization documentation (electronic forms or
templates) from a health IT system;
Electronically submit completed documentation for prior
authorization to a payer's API, along with supporting information;
Receive a response from a payer regarding approval, denial
(including a reason for denial), or need for additional information;
Query a payer's system for updates on a pending prior
authorization request and have a reason returned as to why a request is
still pending; and
[[Page 3478]]
Effectively capture and persist digital signatures (or
other indications of provider review and assent), enable data integrity
of documentation over time, and support other features necessary to
meet payer administrative requirements associated with prior
authorization transactions.
We invite further comment on whether these are the appropriate
minimum capabilities needed for certified health IT systems to
successfully interact with payer systems to complete key electronic
prior authorization activities.
e. Implementation Specifications To Support Electronic Prior
Authorization Capabilities
As noted above, in the ONC Healthcare Operations Standards proposed
rule ONC proposed to adopt, on behalf of HHS, three implementation
specifications relevant to electronic prior authorization (85 FR
82632):
HL7[supreg] FHIR[supreg] Da Vinci Coverage Requirements
Discovery (CRD) Implementation Guide.\8\
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\8\ For more information, see https://www.hl7.org/fhir/us/davinci-crd/.
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HL7[supreg] FHIR[supreg] Da Vinci Documentation Templates
and Coverage Rules (DTR) Implementation Guide.\9\
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\9\ For more information, see https://hl7.org/fhir/us/davinci-dtr/.
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HL7[supreg] FHIR[supreg] Da Vinci Prior Authorization
Support (PAS) Implementation Guide.\10\
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\10\ For more information, see https://hl7.org/fhir/us/davinci-pas/.
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These IGs were developed by the Da Vinci project, an initiative
established in 2018 to help payers and providers positively impact
clinical, quality, cost, and care management outcomes.\11\ The Da Vinci
project is part of the HL7[supreg] FHIR[supreg] Accelerator
Program.\12\ Under the Da Vinci project, industry stakeholders have
facilitated the definition, design, and creation of use-case-specific
implementation documentation and supporting materials based upon the
HL7[supreg] FHIR[supreg] standard in order to address value-based care
initiatives. Because the Da Vinci project is aligned with HL7[supreg]
and its consensus-based approach to standards development, new and
revised standards are easily and freely available for public use. While
ONC proposed to adopt these IGs in the ONC Healthcare Operations
Standards proposed rule in tandem with the proposed requirements for
payers in the CMS Interoperability and Prior Authorization proposed
rule (85 FR 82632), we are now seeking to understand the
appropriateness of using these IGs to support functionality within
certified health IT systems used by healthcare providers and other
stakeholders.
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\11\ For more information, see https://www.hl7.org/about/davinci/.
\12\ For more information, see https://www.hl7.org/documentcenter/public/pressreleases/HL7_PRESS_20190211.pdf.
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Below we offer a description of each IG and a discussion of key
issues to help the public provide input.
Da Vinci Coverage Requirements Discovery (CRD) Implementation Guide
The purpose of this IG is to define a workflow whereby clinical IT
systems can query coverage requirements from payer IT systems at the
time treatment decisions are made. This ensures that clinicians and
administrative staff can make informed decisions and meet the
requirements of the patient's insurance coverage. Different insurance
products may have varying requirements for prior authorization
documentation. Providers who fail to adhere to payer requirements may
not receive payer coverage for care provided or may cause a delay in
needed care, which may result in increased out of pocket costs for
patients, potential additional visits and changes in the preferred care
plan, health risks for the patient, and increased burden for all
parties involved.
This IG utilizes the Clinical Decision Support (CDS) Hooks
specification \13\ in order to: Establish triggers for querying payers
for coverage requirements; define how payers publish services
describing coverage requirements; define how clinical systems query
payers for coverage requirements; and define how clinical systems
present coverage requirements to users for clinical decision support.
The CRD IG allows provider IT systems to query payer IT systems via CDS
Hooks to determine if there are documentation requirements for a
proposed medication, procedure, or other service. When a provider
triggers a prior authorization-related CDS Hook within their IT system
indicating that payer documentation requirements exist for a product or
service, a CDS Hooks Card(s) is returned with information about the
documentation requirements and options to read, accept a suggestion, or
interact with an app to address those requirements.
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\13\ For more information, see https://cds-hooks.hl7.org/.
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The CRD IG extends the CDS Hooks specification to define additional
hook resources, a hook configuration mechanism, additional prefetch
capabilities, and additional response capabilities. In addition to the
reliance of this IG on the nascent CDS Hooks specification, these
extensions may change in the future, depending on how they are
incorporated into the CDS Hooks specification, which may cause
compatibility issues with future versions of the CRD IG.
The information that may be shared using this IG includes:
Updated coverage information.
Alternative preferred/first-line/lower-cost services/
products.
Documents, rules, forms, templates, and links to resources
related to coverage.
Updated clinical information for decision support.
Indications of whether prior authorization is required.
Documentation Templates and Coverage Rules (DTR) Implementation Guide
The purpose of the DTR IG is to ensure the completion of
documentation needed to demonstrate medical necessity for a proposed
medication, procedure, or other service. This IG specifies how payer
coverage rules can be executed in a provider context to ensure that
documentation requirements are met. A companion to the CRD IG, the DTR
IG leverages the ability of CDS Hooks Cards to link to Substitutable
Medical Applications, Reusable Technologies (SMART) on FHIR \14\ apps
to launch and execute payer rules. The DTR IG describes the
interactions between a SMART on FHIR app and the payer's IT system to
retrieve the payer's documentation requirements, in the form of
Clinical Quality Language (CQL) \15\ and a FHIR Questionnaire resource,
for use by the provider and the provider's IT system. The provider's IT
system communicates with the payer's IT system, which informs the
provider's system of the documentation that needs to be completed using
the CQL logic and the FHIR Questionnaire resource. To populate the FHIR
QuestionnaireResponse, which are the results of the FHIR Questionnaire
resource, the IG describes a process where the provider's IT system
auto-populates as many fields as possible, then alerts the provider to
any information gaps, which the provider can complete manually. The IG
describes that all relevant information from these transactions is
stored in the provider's IT system for future use, including to support
subsequently providing the FHIR QuestionnaireResponse to the payer as
[[Page 3479]]
part of documentation for prior authorization.
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\14\ For more information, see https://docs.smarthealthit.org/
\15\ For more information, see https://cql.hl7.org/
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Da Vinci Prior Authorization Support (PAS) Implementation Guide
The PAS IG uses the FHIR standard as the basis for (i) assembling
the information necessary to substantiate clinical need for a
particular treatment; and (ii) submitting the assembled information and
prior authorization request to an intermediary before transmission to
the intended recipient. Under the workflow specified in the PAS IG, to
meet regulatory requirements for HIPAA standard transactions discussed
above, the FHIR interface communicates with an intermediary
functionality (such as a clearinghouse) that converts the FHIR requests
to a HIPAA compliant X12 278 request transaction for submission to the
payer. In some cases, the payer itself, if acting as the intermediary
or clearinghouse, may convert the request to a HIPAA compliant X12 278
transaction. Under the workflow specified in the PAS IG, the response
from the payer would then flow back through the intermediary
functionality using X12 and would be made available to the provider's
health IT system using the FHIR standard. The response would indicate
whether the payer approves (and for how long), denies (with a reason
for denial), or requests more information about the prior authorization
request. This IG also defines capabilities around the management of
prior authorization requests, including checking on the status of a
previously submitted request, revising a previously submitted request,
and cancelling a request.
Discussion
Based on public input to date, including comments received on the
CMS Interoperability and Prior Authorization and ONC Healthcare
Operations Standards proposed rules in December 2020, and our own
review, we have identified a number of issues that may be relevant to
the use of these IGs in certified health IT. These include concerns
that the IGs lack maturity and have not yet undergone extensive testing
in production and rely on other IGs and features in FHIR that are
immature. In some cases, the available versions of the IGs propose
changes and pre-adopt changes to dependent IGs, or request feedback on
design considerations within the IGs that may impact compatibility
between these versions and future versions. Additional issues regarding
the PAS IG include concerns around the translation from FHIR to X12
included as part of the specification. While enabling compliance with
existing regulatory requirements, the translation approach may increase
the number of transactions necessary for exchange as well as dependency
on intermediaries. Issues regarding the DTR and CRD IGs include
concerns that the detailed workflow described in the specification
leverages CDS Hooks functionality, which has not yet been adopted in
any certification criterion under the Certification Program. We welcome
additional information about these IGs, especially given that a year
has passed since we last heard from the public on this topic as part of
the ONC Healthcare Operations Standards proposed rule.
f. Additional Approaches To Support Electronic Prior Authorization:
Healthcare Attachments
The implementation specifications described above represent
important standards development collaborations between industry
stakeholders. We believe these activities may present an important
pathway to streamlining electronic prior authorization processes, as
reflected in our proposal in the ONC Healthcare Operations Standards
proposed rule. However, we understand that there are capabilities and
standards currently supported by certified health IT products that may
facilitate certain elements of prior authorization workflows. For
instance, electronic exchange of healthcare attachments can be used to
transmit clinical information in conjunction with an electronic
administrative transaction to meet health plan requirements. ONC is
aware of several standards initiatives within the last five years
focused on advancing standards and functionality supporting clinical
documents for a broad range of use cases, including for attachments
within prior authorization and other administrative workflows.
These initiatives include the HL7 implementation guide based on the
Consolidated Clinical Document Architecture (C-CDA) Release, and HL7
FHIR Documents:
HL7 C-CDA R2 Attachment Implementation Guide: Exchange of
C-CDA Based Documents, Release 1.\16\
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\16\ For more information, see https://www.hl7.org/documentcenter/public/standards/dstu/CDAR2_AIG_CCDA_EXCHANGE_R1_STU_2017AUG.pdf.
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HL7 FHIR Release 4, Section 3.3: FHIR Documents.\17\
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\17\ For more information, see https://www.hl7.org/fhir/documents.html.
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The HL7 C-CDA R2 Attachment Implementation Guide (CDA Attachments
IG) defines the requirements for sending and receiving standards-based
electronic attachments and incorporates certain administrative
information into the document header. The C-CDA document templates are
designed to be electronic versions of the most common types of paper
document attachment information. ONC has adopted the C-CDA standard for
use in the Certification Program in Sec. 170.205.
An HL7 FHIR Release 4 FHIR Document (FHIR Documents) is a set of
healthcare-related information that is assembled into a single package
that provides a coherent statement, establishes its own context, and
includes attribution with regard to who is making the statement. The
FHIR Documents section of the base FHIR Release 4 standard (adopted by
ONC in Sec. 170.215) specifies how FHIR resources can be used to build
documents that represent a statement of healthcare information,
including representing clinical observations and services as a cohesive
composition. The resulting document is an immutable set of resources
with a fixed presentation that can be used for a wide range of use
cases, including administrative transactions.
Discussion
Healthcare and health IT stakeholders have called for a
standardized approach to electronic healthcare attachments, while
emphasizing that solutions should align with advances in
interoperability and that HHS policy should allow for innovation (for
example, see public comments received by the HITAC in 2019,\18\ the
NCVHS in 2018,\19\ 2020,\20\ and 2021,\21\ and the joint ICAD taskforce
in 2020). Because of the ongoing advancement of health IT standards and
functionality supporting clinical and care coordination workflows,
there are several options available for interoperable exchange today,
including both document-based exchange using the C-CDA base standard
and exchange using standardized APIs using the FHIR base standard. This
increase in interoperable options can support the combination of
clinical and administrative data and allow for more timely and
effective
[[Page 3480]]
approvals of prior authorization requests.
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\18\ See https://www.healthit.gov/sites/default/files/facas/2019-03-20_HITAC_Meeting_Notes.pdf.
\19\ See https://ncvhs.hhs.gov/transcripts-minutes/transcript-standards-subcommittee-predictability-roadmap-hearing-day-one-december-12-2018/ and https://ncvhs.hhs.gov/transcripts-minutes/transcript-standards-subcommittee-predictability-roadmap-hearing-day-two-december-13-2018/.
\20\ See https://ncvhs.hhs.gov/wp-content/uploads/2020/10/Public-Comments-CAQH-CORE-Operating-Rules-for-Federal-Adoption-August-2020r.pdf.
\21\ See https://ncvhs.hhs.gov/wp-content/uploads/2021/08/Public-Comments-Standards-Subcommittee-Listening-Session-August-25-2021.pdf.
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We understand that stakeholders may also have concerns with these
potential approaches, for instance, concerns related to lack of testing
and production implementation of these approaches that are specific to
the prior authorization use case, despite widespread use of the
underlying standards for other purposes. Regarding the underlying
standards for each approach, we understand that while the C-CDA has the
benefit of being in widespread use, the more inflexible nature of the
standard may increase the ongoing burden of maintenance and updates to
the standard over time. FHIR solutions offer a more flexible and agile
option over time, but there may be additional development and
specification needed for their effective implementation. We welcome
additional information about these standards and implementation
specifications for this part of the prior authorization workflow.
We also welcome further information on any other additional areas
we should consider in supporting the exchange of healthcare attachments
in prior authorization workflows. For example, we understand there is
also ongoing work to create a FHIR-based IG for healthcare
attachments.\22\ In addition, while the scope of this RFI is focused on
prior authorization processes, we recognize that the systems used for
this purpose may also support a wide range of administrative
transactions and operations workflows and that healthcare attachments
are used for other administrative and operations purposes such as
claims processing. In the same way that aligned standards between
administrative systems and clinical systems can optimize effectiveness,
aligned standards across administrative use cases may also support
efficiency. We therefore welcome public comment on the potential
intersection with other administrative and operations processes that we
should consider when exploring options for healthcare attachments, as
well as comments on how to best harmonize these efforts. Finally, we
welcome public comment on other standards initiatives, pilot projects,
or health IT resources that we should explore to identify promising
best practices, emerging standards, or innovative approaches to advance
interoperable health IT for healthcare operations use cases.
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\22\ For more information, see https://build.fhir.org/ig/HL7/davinci-ecdx/.
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II. Request for Comments
ONC seeks public comments on whether to adopt additional standards,
implementation specifications, and certification criteria as part of
the Certification Program to ensure that technology is available to
providers for the automated, electronic completion of prior
authorization tasks. In addition to general comments on the issues
presented above, we are seeking input on the following questions:
Certified Health IT Functionality
Do the functional capabilities described above include all
necessary functionality for certified Health IT Modules to successfully
facilitate electronic prior authorization processes? Are there
additional capabilities that should be included in certified Health IT
Modules to address these needs? Should any of these functional
capabilities not be included in certified Health IT Modules (please
cite the reason they should be excluded) or should ONC focus on a more
limited set of functional capabilities for certified Health IT Modules
than those described above?
Should ONC adopt a certification criterion for prior
authorization that accounts for the full, HIPAA compliant workflow for
prior authorization transactions including translation from FHIR to the
X12 standard? Or should ONC adopt certification criteria that include
only the workflows up to the point of translation? What ongoing
challenges will stakeholders face if there is a need to translate
between HIPAA-adopted standards and other standards that have only been
adopted under the Certification Program used to support prior
authorization transactions? How should HHS address alignment between
standards adopted for HIPAA transactions and standards adopted under
the Certification Program?
If ONC were to propose to include these functional
capabilities as part of the Certification Program, how should a new
certification criterion (or multiple certification criteria) be
structured, including technical requirements, attributed standards, and
implementation specifications? ONC's experience adopting certification
criteria suggests that, at times, combining related functions into a
single Health IT Module is most appropriate, while in other cases,
health IT functionalities are best represented by separate
certification criteria, despite being functionally related. For
instance, under a single criterion, different products and services in
the market may be ``tightly coupled'' for the purposes of
certification, even when they can be purchased and implemented
separately. We seek the public's input on which functional capabilities
for prior authorization should be tested and certified together as part
of one certification criterion, and which capabilities should be
separated into different certification criteria.
Implementation Specifications for Prior Authorization
What is the current readiness of the three FHIR-based Da
Vinci IGs described above for adoption as part of certification
criteria for health IT? Given limited testing of these specifications
to date, what would be a feasible timeline for use of these IGs in
production for prior authorization transactions? What, if any,
additional changes are needed for these IGs prior to adoption as part
of certification criteria for health IT?
If the existing IGs are not yet ready for adoption, should
ONC still propose certification criteria? Should ONC consider proposing
certification criteria incorporating the FHIR Release 4 base standard
but delay adopting implementation specifications until a later date?
What are the potential risks of this approach?
If we were to adopt certification criteria referencing the
base standard and then update those criteria to integrate
implementation specifications in the future, how should these
integrations be handled? When and how should the existing systems be
replaced? All at once, or as a series of transitional steps?
Do the Da Vinci IGs effectively support Federal and state
legal requirements and/or health plan compliance requirements for
clinical documentation, for example, signatures (or other indications
of provider review and assent), record retention over long periods of
time, and document security to ensure data integrity once stored?
What alternative approaches to designing certification
criteria should ONC explore that are not based on the three Da Vinci
IGs described herein?
Are there simplified approaches to the workflows described
in the Da Vinci IGs that ONC should consider as alternative approaches
to support electronic prior authorization?
Are there new IGs which need to be developed in order to
integrate with other workflows relevant to prior authorization? In
particular, what IGs may still need to be developed in order to
integrate with HIPAA administrative transaction standards?
[[Page 3481]]
Healthcare Attachment Standards
Would the specifications within the CDA Attachments IG, if
adopted as part of a certification criterion, support more effective
exchange of healthcare attachments for prior authorization? Would any
changes to the IG be needed, or would additional functionalities or
standards be required for effective implementation of the CDA
Attachments IG in certified health IT?
Would the use of FHIR Documents, if adopted as part of a
certification criterion, support more effective exchange of healthcare
attachments? Are there any gaps or constraints that would need to be
further specified, such as through an IG, in order for FHIR Documents
to be effective for this use case when implemented in certified health
IT? Would the adoption of a certification criterion for FHIR Documents
support other administrative use cases beyond prior authorization?
Given limited testing of these approaches to date, what
would be a feasible timeline for use of the CDA Attachments IG or FHIR
Documents in production for prior authorization transactions?
Which of these approaches would better accommodate
improvements over time to meet payer and provider needs? Should ONC
consider adopting certification criteria referencing one approach over
the other, or should ONC consider supporting both approaches within
certified health IT?
If the IGs developed by the Da Vinci Project, or an
alternate set of IGs addressing the full scope of prior authorization
workflows, are not yet ready for adoption in certified health IT,
should ONC propose certification criteria to support healthcare
attachments transactions for prior authorization alone?
Healthcare attachments are used for a wide range of
operations and administrative workflows beyond prior authorization. Are
either of the standards discussed above commonly used in other
administrative or operations transactions? Would there be a burden or
benefit to using either, or both, standards in light of other
administrative or operations workflows? Are there additional standards
or implementation specifications ONC should consider that are in common
use for healthcare attachments used in other administrative or
operations workflows?
Impact on Patients
How could potential changes to the Certification Program
to better support prior authorization positively impact healthcare
consumers?
How could potential changes reduce the time for patients
to receive needed healthcare services, reduce patient non-adherence,
and/or lower out-of-pocket costs?
Besides the provider to payer interactions discussed in
this RFI, is there additional functionality that could be added to the
Certification Program that would better support patients' participation
in the prior authorization process?
Impact on Providers
To what degree is availability of electronic prior
authorization capabilities within certified health IT likely to reduce
burden for healthcare providers who currently engage in prior
authorization activities?
To what degree are healthcare providers likely to use
these new capabilities across their patient panels? Will additional
incentives or requirements be needed to ensure healthcare providers
effectively use these capabilities? What accompanying documentation or
support would be needed to ensure that technology capabilities are
implemented in ways that effectively improve clinical workflows?
What estimates can providers share about the cost and time
(in hours) associated with adopting and implementing electronic prior
authorization functionality as part of care delivery processes?
Impact on Developers
What estimates can health IT developers share about the
cost and time (in hours) of developing electronic prior authorization
functionality within certified health IT products?
What factors would inform the burden for health IT
developers to develop certified Health IT Modules for electronic prior
authorization based on the three Da Vinci IGs described above?
What would be the burden on health IT developers for prior
authorization certification criteria referencing the base FHIR standard
if there were not yet specific IGs adopted as well? How would
potentially moving to criteria with use case specific IGs over time
impact development burden? Would such a staged approach be detrimental
or beneficial to the long-term development timeline and burden for
health IT developers seeking to support electronic prior authorization?
Payer Implementation
How could the Certification Program support the technology
needs of healthcare payers in implementing electronic prior
authorization? Should ONC consider payer workflows in the development
of certification criteria to support the potential use of certified
Health IT Modules by healthcare payers? Would the availability of
certified Health IT Modules supporting these workflows reduce the
burden for healthcare payers of engaging with healthcare providers in
prior authorization processes?
To what extent would healthcare payers be likely to use
these certified Health IT Modules if they were available? To what
extent are health IT developers likely to seek certification for Health
IT Modules supporting payer workflows if these certification criteria
were available?
Dated: January 19, 2022.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2022-01309 Filed 1-21-22; 8:45 am]
BILLING CODE 4150-45-P