Notice2022-21904
Request for Information; National Directory of Healthcare Providers & Services
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 7, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This request for information solicits public comments on establishing a National Directory of Healthcare Providers & Services (NDH) that could serve as a "centralized data hub" for healthcare provider, facility, and entity directory information nationwide.
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<title>Federal Register, Volume 87 Issue 194 (Friday, October 7, 2022)</title>
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[Federal Register Volume 87, Number 194 (Friday, October 7, 2022)]
[Notices]
[Pages 61018-61029]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-21904]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-0058-NC]
RIN 0938-ZB72
Request for Information; National Directory of Healthcare
Providers & Services
AGENCY: Centers for Medicare & Medicaid Services (CMS), Health and
Human Services (HHS).
ACTION: Request for information.
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SUMMARY: This request for information solicits public comments on
establishing a National Directory of Healthcare Providers & Services
(NDH) that could serve as a ``centralized data hub'' for healthcare
provider, facility, and entity directory information nationwide.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on December 6, 2022.
ADDRESSES: In commenting, please refer to file code CMS-0058-NC.
Comments, including mass comment submissions, must be submitted in
one of the following three ways (please choose only one of the ways
listed):
1. Electronically. You may submit electronic comments on this
regulation to <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-0058-NC, P.O. Box 8013,
Baltimore, MD 21244-8013.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-0058-NC, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Alexandra Mugge, (410) 786-4457.
David Koppel, (303) 844-2883.
SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments
received before the close of the comment period are available for
viewing by the public, including any personally identifiable or
confidential business information that is included in a comment. We
post all comments received before the close of the comment period on
the following website as soon as possible after they have been
received: <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow the search instructions on
that website to view public comments. CMS will not post on
<a href="http://Regulations.gov">Regulations.gov</a> public comments that make threats to individuals or
institutions or suggest that the individual will take actions to harm
the individual. CMS continues to encourage individuals not to submit
duplicative comments. We will post acceptable comments from multiple
unique commenters even if the content is identical or nearly identical
to other comments.
I. Introduction
Healthcare directories that contain aggregated information about
healthcare providers, facilities, and other entities involved in
patient care are crucial resources for consumers and the healthcare
industry. Contemporary and comprehensive directories can support a
variety of use cases, such as helping consumers choose a provider,
comparing health plan networks, auditing network adequacy, and
coordinating patients' care.\1\ Today, consumers use provider
directories and online searches more than any other resource (such as
word-of-mouth or physician referrals) to research healthcare providers.
In a 2020 consumer preference report, a majority of the consumers
surveyed indicated that the online availability of accurate directory
information (address, insurance, specialty, hours, etc.) has affected
their decisions when choosing a doctor.\2\
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\1\ ONC Health IT. (2016, February). Strategic Implementation
Guide: Provider Directories. See page 4. Retrieved from <a href="https://www.healthit.gov/sites/default/files/statestrategicimplementationguide-providerdirectories-v1-final.pdf">https://www.healthit.gov/sites/default/files/statestrategicimplementationguide-providerdirectories-v1-final.pdf</a>.
\2\ <a href="http://Doctor.com">Doctor.com</a>. (2020). Customer Experience Trends in
Healthcare. Retrieved from <a href="https://cms.doctor.com/wp-content/uploads/2020/03/cxtrends2020-report-final.pdf">https://cms.doctor.com/wp-content/uploads/2020/03/cxtrends2020-report-final.pdf</a>.
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Although these are important resources, the fragmentation of
current provider directories requires inefficient, redundant reporting
from providers.\3\ Directories often contain inaccurate information,
rarely support interoperable data exchange or public health reporting,
and are overall costly to the healthcare industry. According to one
estimate from a provider survey completed in 2019 by the Council for
Affordable Quality Healthcare (CAQH), physician practices collectively
spend $2.76 billion annually on directory maintenance, which is
equivalent to approximately $998.84 per month per practice, or one
staff member workday per week.\4\
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\3\ We use the term ``providers'' generally in this RFI to refer
to healthcare facilities and practitioners and do not intend that to
include or exclude any specific category of individuals or entities.
\4\ CAQH. (2019). The Hidden Causes of Inaccurate Provider
Directories. Retrieved from <a href="https://www.caqh.org/sites/default/files/explorations/CAQH-hidden-causes-provider-directories-whitepaper.pdf">https://www.caqh.org/sites/default/files/explorations/CAQH-hidden-causes-provider-directories-whitepaper.pdf</a>.
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The CAQH estimated that transitioning directory data collection to
a single streamlined platform could save the average physician practice
an estimated $4,746 annually, or an approximated $1.1 billion in
collective annual savings across the nation. Directory maintenance
costs for physician practices vary based on many factors including
practice size, the number of payers with which they are contracted,
number of practice locations, and importantly, how often and timely
they verify or update their information in directories. Furthermore,
providers reported that they must submit directory information in
various ways, including by fax, credentialing software, provider
management and enrollment software, phone, and physical mail. This
disjointed system results in barriers to patient care, administrative
burden on providers and their staff, and increased cost for the entire
healthcare industry.\5\
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\5\ Ibid.
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One driver of inaccuracy is the varying frequencies and levels of
detail at which different directories require information. Some track
directory information at the practice level, and others include
directory information for each physical location. Without processes or
internal audits for data accuracy, different practice staff may provide
inconsistent information across
[[Page 61019]]
directories. Administrative complexity and unclear accountability for
data accuracy also contributes to data quality and accuracy challenges.
Even when payers have legal obligations to maintain an accurate
directory, as discussed in section II. of this document, they generally
must rely on providers to update the information within their
directories and are left with few options if a provider does not do so
in a timely manner. This also puts a burden on provider staff, who must
update their directory information for an average of 20 different
payers per practice.\6\
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\6\ CAQH. (2019). The Hidden Causes of Inaccurate Provider
Directories, See page 2. Retrieved from <a href="https://www.caqh.org/sites/default/files/explorations/CAQH-hidden-causes-provider-directories-whitepaper.pdf">https://www.caqh.org/sites/default/files/explorations/CAQH-hidden-causes-provider-directories-whitepaper.pdf</a>.
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We believe that CMS may have an opportunity to alleviate some of
these burdens and improve the state of provider directories through a
CMS-developed and maintained, Application Programming Interface (API)-
enabled, national directory. A National Directory of Healthcare
Providers & Services (NDH) could serve as a ``centralized data hub''
for directory and digital contact information containing the most
accurate, up-to-date, and validated (that is, data that is verified by
CMS against primary sources) data in a publicly accessible index.\7\ An
NDH could both streamline existing data across CMS systems and publish
information in an easier-to-use format than is available today. More
useful public data could help patients find providers, facilitate
interoperable provider data exchange, and help payers improve the
accuracy of their own directories. We use the term ``centralized data
hub'' to describe the practice of aggregating data from many existing
systems into a single location, which is a best practice within any
industry, including healthcare. Establishing a ``centralized data hub''
breaks down technological barriers between various data sets and allows
other databases to reference the source of the information without
duplicating data. This aggregation and standardization of data could
help avoid errors and inaccuracies in directories that reference data
in an NDH. CMS could use an NDH as a mechanism to collect and maintain
directory information in a standardized, interoperable, and sharable
format that allows widespread access while maintaining privacy and
security protocols to safeguard access to sensitive information.
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\7\ To address digital contact information, section 4003(c)(1)
of the 21st Century Cures Act requires the Secretary of Health and
Human Services to ``establish a provider digital contact information
index to provide digital contact information for health
professionals and health facilities.''
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To align with national standards for interoperability, an NDH could
be built on the standards established by the Office of the National
Coordinator for Health Information Technology (ONC) at 45 CFR part 170,
subpart B. Specifically, an NDH could use HL7[supreg] Fast Healthcare
Interoperability Resources (FHIR[supreg]) APIs, the latest standard for
which is codified at 45 CFR 170.215(a)(1), to enable data exchange.
FHIR is a standard for exchanging healthcare information electronically
that enables rapid and efficient data transactions through an
API.<SUP>8 9</SUP> Systems with different data architecture can use
FHIR APIs to exchange health data in a consistent manner, which gives
providers, payers, and other relevant entities a fast and secure way to
send and receive healthcare data. FHIR is a widely adopted standard
that we already require for specific types of health data exchange.\10\
We expect ONC to periodically update the standards at 45 CFR part 170,
subpart B through notice and comment rulemaking, and an NDH could use
the most up-to-date standards, as appropriate.
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\8\ HL7. (2022, May 28). Welcome to FHIR. Retrieved from <a href="http://hl7.org/fhir/">http://hl7.org/fhir/</a>.
\9\ Health IT. (2021, June 16). FHIR Fact Sheets. Retrieved from
https://www.healthit.gov/topic/standards-technology/standards/fhir-
fact-
sheets#:~:text=What%20is%20HL7%C2%AE%20FHIR,be%20quickly%20and%20effi
ciently%20exchanged.
\10\ CMS. (2020, May 1). 85 FR 25510. See page 25521-22, 25530.
Retrieved from <a href="https://www.federalregister.gov/d/2020-05050">https://www.federalregister.gov/d/2020-05050</a>.
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ONC and the Federal Health Architecture (FHA), a former federal
agency collaboration created to enhance interoperability among federal
health information technology (IT) systems,\11\ developed the Validated
Healthcare Directory (VHDir) FHIR Implementation Guide (IG), which
describes the technical design considerations for collecting,
validating, verifying, and exchanging data from a central source of
provider data using FHIR standards. That IG is currently a ``standard
for trial use,'' meaning it has been deemed ``ready to implement'' by
the sponsoring work group, but there has not yet been significant
implementation experience.\12\ Testing and development processes are
ongoing toward establishing the IG as a normative standard through the
American National Standards Institute (ANSI)-approved process. CMS will
continue to monitor and work with the appropriate standards development
organizations on this effort.
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\11\ Health IT. (2020, January 17). Federal Health Architecture
(FHA). Retrieved from <a href="https://www.healthit.gov/archive/topic/onc-hitech-programs/federal-health-architecture-fha">https://www.healthit.gov/archive/topic/onc-hitech-programs/federal-health-architecture-fha</a>.
\12\ McKenzie, L. & Peters, M. (2021, March 3). HL7 Balloting.
Retrieved from <a href="https://confluence.hl7.org/display/HL7/HL7+Balloting">https://confluence.hl7.org/display/HL7/HL7+Balloting</a>.
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Previous healthcare directory technical efforts, described in
section II. of this document, have identified CMS as the appropriate
owner of a validated directory, such as an NDH.\13\ We agree that CMS,
with collaborative input from industry and federal partners, is
positioned to develop an NDH in a manner that serves all stakeholders,
builds and maintains trust in the data, advances public health goals,
improves data exchange, streamlines administrative processes, and
promotes interoperability.
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\13\ FAST. (2020, December 17). Proposed Solutions Working
Document: Directory (V3). Retrieved from <a href="https://oncprojectracking.healthit.gov/wiki/display/TechLabSC/Directory%2C+Versions+and+Scale+Tiger+Team?preview=/46301216/183107855/FAST-PS-Directory%20V3_122320.docx">https://oncprojectracking.healthit.gov/wiki/display/TechLabSC/Directory%2C+Versions+and+Scale+Tiger+Team?preview=/46301216/183107855/FAST-PS-Directory%20V3_122320.docx</a>.
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Through this RFI, we seek input on the current state of healthcare
provider directories and steps that we could or should take if CMS
concludes that adequate legal authority exists to establish an NDH and
proceeds to do so.
We believe a modern healthcare provider directory should serve
multiple purposes for end users. In addition to helping patients locate
providers that meet their individual needs and preferences, a modern
healthcare directory should enable healthcare providers, payers, and
others involved in patient care to identify one another's digital
contact information, also referred to as digital endpoints,\14\ for
interoperable electronic data exchange. We are collecting feedback from
the public regarding the topics and questions in the discussion that
follows. We pose questions throughout this document; a response to
every question is not required in order to submit comments.
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\14\ CMS. (2022, February 11). OBRHI FAQs. Retrieved from
<a href="https://www.cms.gov/about-cms/obrhi/faqs">https://www.cms.gov/about-cms/obrhi/faqs</a>.
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II. Background
Provider directories have long been a focus of federal healthcare
improvement efforts. On several occasions, Congress has acted to
address the challenges of directory data availability and accuracy.
Federal executive branch departments and agencies have also taken
considerable steps to implement regulatory requirements aimed at
addressing these challenges.
Section 4001 of the Balanced Budget Act of 1997 (BBA) (Pub. L. 105-
33) established a new Medicare Part C (now also known as Medicare
Advantage) program, and under section
[[Page 61020]]
1852(c)(1)(C) of the Social Security Act (the Act) required that
Medicare Advantage organizations (MA organizations) annually disclose
in a clear, accurate, and standardized form to each MA plan enrollee,
the number, mix, and distribution of plan providers, among other
information.
This requirement was implemented in regulations at 42 CFR
422.111(b)(3), which requires MA organizations to disclose a
description of the number, mix, and distribution (addresses) of
providers from whom enrollees may reasonably be expected to obtain
services. CMS has issued updated guidance over several years regarding
the responsibilities of MA organizations to have accurate provider
directories, with guidance appearing in the Medicare Marketing
Guidelines and Medicare Communications and Marketing Guidelines
<SUP>15 16</SUP> and section 110 of Chapter 4 of the Medicare Managed
Care Manual.<SUP>17 18</SUP>
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\15\ CMS. (2022, February 9). Medicare Communications and
Marketing Guidelines (MCMG). Retrieved from <a href="https://www.cms.gov/files/document/medicare-communications-marketing-guidelines-2-9-2022.pdf">https://www.cms.gov/files/document/medicare-communications-marketing-guidelines-2-9-2022.pdf</a>.
\16\ Prior to 2020, CMS issued the Medicare Marketing Guidelines
(historical versions are available through the HHS Guidance Portal,
available online here: <a href="https://www.hhs.gov/guidance/">https://www.hhs.gov/guidance/</a>) but replaced
that document with the Medicare Communications and Marketing
Guidelines when the applicable regulations were revised in a final
rule that appeared in the Federal Register on April 16, 2018 (83 FR
16440, 16624 through 16633).
\17\ CMS. (2015, April 22). Medicare Managed Care Manual
Publication # 100-16: Chapter 4--Benefits and Beneficiary
Protections. Retrieved from <a href="https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/internet-Only-Manuals-IOMs-Items/CMS019326">https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/internet-Only-Manuals-IOMs-Items/CMS019326</a>.
\18\ CMS. (2016, April 22). Medicare Managed Care Manual:
Benefits and Beneficiary Protections. Retrieved from <a href="https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/mc86c04.pdf">https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/mc86c04.pdf</a>.
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Similarly, in section 4701 of the BBA, Congress added section
1932(a)(5)(B)(i) of the Act, which requires that the Medicaid managed
care organizations that are specified in the statute make available,
upon request, the identity, locations, qualifications, and availability
of providers that participate with that entity. These same requirements
were applied to Children's Health Insurance Program (CHIP) managed care
entities via section 403 of the Children's Health Insurance Program
Reauthorization Act (CHIPRA) of 2009 (Pub. L. 111-3), at section
2103(f)(3) of the Act.
In 2015, in the ``Patient Protection and Affordable Care Act; HHS
Notice of Benefit and Payment Parameters for 2016'' final rule (80 FR
10829), we established a requirement, at 45 CFR 156.230(b), that
Qualified Health Plan (QHP) issuers on the Federally-facilitated
Exchanges publish online an easily-accessible, up-to-date, accurate,
and complete provider directory. Those directories must include
information on which providers are accepting new patients, the
provider's location, contact information, specialty, medical group, and
any institutional affiliations. CMS also requires issuers to make this
information publicly available on their own websites in a machine-
readable file and format to allow third parties to create resources
that aggregate information on different plans.<SUP>19 20</SUP> CMS
conducts annual reviews to assess the accuracy of issuers' machine-
readable provider data files, comparing the data files to the issuers'
online provider directories and other data sources, such as the
National Plan and Provider Enumeration System (NPPES) and the United
States Postal Service (USPS) address verification database. Over five
plan years beginning in plan year (PY) 2017 through PY2021, CMS found
that no more than 47 percent of the provider entries we reviewed from
the machine-readable provider data files included a complete set of
accurate telephone numbers, addresses, specialties, plan affiliations,
and whether the provider is accepting new patients.\21\ Furthermore,
only 73 percent of the providers reviewed could be fully matched to the
published directories on the payer's website. Finally, when we compared
provider information from the machine-readable data files to the NPPES
National Provider Identifier (NPI) registry, only 28 percent of the
provider names, addresses, and specialties matched.\22\ In addition to
accuracy issues, we note that a machine-readable file is a static data
source that must be entirely recreated to provide a snapshot of the
dataset at any point in time. Conversely, the APIs that we discuss here
could allow data to be accessed in real-time and with the most up-to-
date information at the moment the system is queried.
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\19\ CMS. (2022, January 7). 2023 Letter to Issuers in the
Federally-facilitated Exchanges, Chapter 3, Section 1. Retrieved
from <a href="https://www.cms.gov/files/document/2023-draft-letter-issuers-508.pdf">https://www.cms.gov/files/document/2023-draft-letter-issuers-508.pdf</a>.
\20\ CMS. (2017, February 17). Addendum to 2018 Letter to
Issuers in the Federally-facilitated Marketplaces. Retrieved from
<a href="https://www.cms.gov/CCIIO/Resources/Regulations-and-Guidance/Downloads/Final-2018-Letter-to-Issuers-in-the-Federally-facilitated-Marketplaces-and-February-17-Addendum.pdf">https://www.cms.gov/CCIIO/Resources/Regulations-and-Guidance/Downloads/Final-2018-Letter-to-Issuers-in-the-Federally-facilitated-Marketplaces-and-February-17-Addendum.pdf</a>.
\21\ CMS selected a sample of 25 providers from 45 QHP and 5
SADP issuers, For each issuer, the target sample was selected to
equally distribute primary care physician (PCP), obstetrics/
gynecology (OB/GYN), pediatrics, and specialty providers for QHPs,
and general dentists, pediatric dentists, and specialty dentists for
SADPs. The provider's National Provider Identification number (NPI)
was used to ensure providers were not chosen more than once during
each plan year review. One SADP in the sample had only 15 unique
NPIs from which a sample could be selected; this resulted in the
final sample size of 1,235 unique NPIs.
\22\ CMS. (2022, March 22). Machine-Readable Provider Directory
Review Summary Report Plan Years 2017-2021. Retrieved from <a href="https://www.cms.gov/files/document/2017-2021mrpdsummaryreportfinal508.pdf">https://www.cms.gov/files/document/2017-2021mrpdsummaryreportfinal508.pdf</a>.
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In the Contract Year 2016 Call Letter for Part C (Medicare
Advantage) and Part D plans, CMS announced it was initiating a
monitoring effort of the accuracy of online provider directories for
plans offered by MA organizations.\23\ Beginning in February 2016, CMS
studied the accuracy of information in MA organizations' online
directories. We released findings in July 2018 from three review rounds
in which we identified at least one deficiency in 45 percent, 55
percent, and 49 percent of listed locations.\24\ Significant types of
identified inaccuracies included providers who did not practice at the
listed location, providers who did not accept the plan at the listed
location, incorrect phone numbers or addresses, and mistaken
``accepting new patients'' flags. In that report, we identified a
centralized database as a possible long-term solution.\25\
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\23\ CMS. (2015, April 6). Announcement of Calendar Year (CY)
2016 Medicare Advantage Capitation Rates and Medicare Advantage and
Part D Payment Policies and Final Call Letter. Retrieved from
<a href="https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Announcement2016.pdf">https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Announcement2016.pdf</a>.
\24\ CMS. (2018, November 28). Online Provider Directory Review
Report. Retrieved from <a href="https://www.cms.gov/Medicare/Health-Plans/ManagedCareMarketing/Downloads/Provider_Directory_Review_Industry_Report_Round_3_11-28-2018.pdf">https://www.cms.gov/Medicare/Health-Plans/ManagedCareMarketing/Downloads/Provider_Directory_Review_Industry_Report_Round_3_11-28-2018.pdf</a>.
\25\ Ibid.
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On January 3, 2020, as a follow-up to the MA provider directory
monitoring study conducted from 2016 to 2018, CMS issued a Health Plan
Management System (HPMS) memo encouraging MA organizations to work with
their contracted providers and to urge those providers to review and
update their NPPES data. CMS announced that it would exercise
enforcement discretion with regard to potential violations of Sec.
422.111(b)(3) should CMS uncover errors in an MA organization's
provider directory where the errors are consistent with NPPES data that
were updated or certified between January 1 and April 30, 2020,
provided the MA organization corrected any identified errors within 30
days.\26\
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\26\ CMS. (2020, January). HPMS Memo. Retrieved from <a href="https://www.cms.gov/httpseditcmsgovresearch-statistics-data-and-systemscomputer-data-and-systemshpmshpms-memos-archive/hpms-memo-3">https://www.cms.gov/httpseditcmsgovresearch-statistics-data-and-systemscomputer-data-and-systemshpmshpms-memos-archive/hpms-memo-3</a>.
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[[Page 61021]]
In 2016, Congress enacted the 21st Century Cures Act (Cures Act)
(Pub. L. 114-255). Section 4003(c) of the Cures Act requires the
Secretary of HHS (the Secretary), directly or through a partnership
with a private entity, to establish a provider digital contact
information index to provide digital contact information for health
professionals and health facilities. To implement that requirement of
section 4003(c) of the Cures Act, in June 2018 we updated NPPES,\27\ a
system authorized by section 1173(b) of the Act and that we administer,
to be able to capture digital contact information, also referred to as
digital endpoints,\28\ for both healthcare professionals and
facilities. NPPES currently supplies NPI numbers to healthcare
providers (both individuals and facilities), maintains their NPI
record, and publishes the records online. NPPES has been updated to
include the capability to capture one or more fields of digital contact
information that can be used to facilitate secure health information
exchange. For instance, providers can submit a type of digital endpoint
such as a Direct address, which functions similar to a regular email
address, but includes additional security measures to ensure that
messages are only accessible by the intended recipient in order to keep
the information confidential and secure.\29\ As NPPES is publicly
searchable on CMS' website, many other entities use the data included
in the NPPES Downloadable File for other business and research purposes
(for example, the Kaiser Family Foundation completed a 2020 report on
the availability of active critical care physicians and nurses in a
state-by-state analysis, relating to COVID-19).\30\
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\27\ CMS. NPPES NPI Registry. Retrieved from <a href="https://npiregistry.cms.hhs.gov/">https://npiregistry.cms.hhs.gov/</a>.
\28\ CMS. (2022, February 11). OBRHI FAQs. Retrieved from
<a href="https://www.cms.gov/about-cms/obrhi/faqs">https://www.cms.gov/about-cms/obrhi/faqs</a>.
\29\ Health IT. (2014, May). Direct Basics: Q&A for Providers.
Retrieved from <a href="https://www.healthit.gov/sites/default/files/directbasicsforprovidersqa_05092014.pdf">https://www.healthit.gov/sites/default/files/directbasicsforprovidersqa_05092014.pdf</a>.
\30\ Lopez, E. (2020, July 30). The Critical Care Workforce and
COVID-19. Retrieved from <a href="https://www.kff.org/report-section/the-critical-care-workforce-and-covid-19-a-state-by-state-analysis-data-note/">https://www.kff.org/report-section/the-critical-care-workforce-and-covid-19-a-state-by-state-analysis-data-note/</a>.
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Additionally, section 4003(b) of the Cures Act amended section
3001(c) of the Public Health Service Act (PHSA) to add a new paragraph
(9)(A) that directed the National Coordinator to ``develop or support a
trusted exchange framework, including a common agreement among health
information networks nationally.'' The overall goal of the Trusted
Exchange Framework and Common Agreement (TEFCA) is to establish a
universal floor for interoperability across the country. Paragraph
(9)(D) of section 3001(c) of the PHSA requires the National Coordinator
to create and publish on ONC's website, ``a list of the health
information networks that have adopted the common agreement and are
capable of trusted exchange pursuant to the common agreement.'' On
January 18, 2022, ONC released the Common Agreement for Nationwide
Health Information Interoperability Version 1 (Common Agreement).\31\
The Common Agreement and the incorporated by reference Qualified Health
Information Network (QHIN) Technical Framework Version 1 (QTF) \32\
establish a technical infrastructure model and governing approach for
different health information networks and their users to securely share
clinical information with each other. The Common Agreement and the QTF
do not require FHIR-based exchange because network enablement of FHIR
is still maturing in key areas. However, the ONC Recognized
Coordinating Entity (RCE),\33\ a private-sector entity that implements
the Common Agreement, released a 3-year FHIR Roadmap for TEFCA
Exchange, which lays out a deliberate strategy to add FHIR-based
exchange under TEFCA in the near future.\34\ The Common Agreement also
includes requirements for maintaining a directory of exchange
participants' digital endpoints.
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\31\ ONC. (2022, January). Common Agreement for National Health
Information Interoperability, Version 1. Retrieved from <a href="https://www.healthit.gov/sites/default/files/page/2022-01/Common_Agreement_for_Nationwide_Health_Information_Interoperability_Version_1.pdf">https://www.healthit.gov/sites/default/files/page/2022-01/Common_Agreement_for_Nationwide_Health_Information_Interoperability_Version_1.pdf</a>.
\32\ ONC TEFCA Recognized Coordinating Entity. (2022, January).
Qualified Health Information Network (QHIN) Technical Framework
(QTF) Version 1.0. Retrieved from <a href="https://rce.sequoiaproject.org/wp-content/uploads/2022/01/QTF_0122.pdf">https://rce.sequoiaproject.org/wp-content/uploads/2022/01/QTF_0122.pdf</a>.
\33\ In August 2019, ONC awarded a cooperative agreement to The
Sequoia Project to serve as the initial RCE. The RCE will
operationalize and enforce the Common Agreement, oversee QHIN-
facilitated network operations, and ensure compliance by
participating QHINs. The RCE will also engage stakeholders to create
a roadmap for expanding interoperability over time. See The Sequoia
Project. (2019, September 4). ONC Awards The Sequoia Project a
Cooperative Agreement for the Trusted Exchange Framework and Common
Agreement to Support Advancing Nationwide Interoperability of
Electronic Health Information. Retrieved from <a href="https://sequoiaproject.org/onc-awards-the-sequoia-project-a-cooperative-agreement-for-the-trusted-exchange-framework-and-common-agreement-to-support-advancing-nationwide-interoperability-of-electronic-health-information">https://sequoiaproject.org/onc-awards-the-sequoia-project-a-cooperative-agreement-for-the-trusted-exchange-framework-and-common-agreement-to-support-advancing-nationwide-interoperability-of-electronic-health-information</a>.
\34\ ONC TEFCA Recognized Coordinating Entity. (2022, January).
FHIR Roadmap for TEFCA Exchange, Version 1. Retrieved from <a href="https://rce.sequoiaproject.org/wp-content/uploads/2022/01/FHIR-Roadmap-v1.0_updated.pdf">https://rce.sequoiaproject.org/wp-content/uploads/2022/01/FHIR-Roadmap-v1.0_updated.pdf</a>.
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Section 5006 of the Cures Act requires Medicaid agencies to publish
online a directory of certain physicians who participate in the state's
fee-for-service (FFS) program. Medicaid agencies must update these
directories at least annually and include providers' names,
specialties, addresses, and telephone numbers. For physicians
participating in a primary care case-management system, the directory
must also indicate whether they are accepting Medicaid beneficiaries as
new patients and the physician's cultural and linguistic capabilities.
Other providers may be included at the state's option, as may certain
additional information such as the physician's or provider's internet
website.
In 2016, ONC and FHA hosted a provider directory workshop to
convene public and private stakeholders, including health IT
developers, organizations, and vendors involved in directory solutions,
to discuss provider directory issues and challenges.<SUP>35 36</SUP>
The workshop highlighted widely held concerns about provider directory
data quality, administrative burden, and consumer satisfaction. To
address these concerns, ONC and FHA launched the Healthcare Directory
initiative. This group developed the VHDir FHIR IG to define the
underlying architecture for a proposed national directory of validated
healthcare data and to provide technical specifications for the
exchange of such information.\37\ FHIR standards and IGs, including the
VHDir IG, are developed through an industry-led, consensus-based public
process. ONC, HHS, and CMS are all engaged in work to promote the
adoption and use of the FHIR standards for interoperability beyond the
provider directory domain.
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\35\ ONC. (2016, June 24). ONC/FHA Provider Directory Workshop.
Retrieved from <a href="https://www.ca-hie.org/site-content/CAHIE-Knowledge-Network-2016-06-24-Healthcare-Directory.pdf">https://www.ca-hie.org/site-content/CAHIE-Knowledge-Network-2016-06-24-Healthcare-Directory.pdf</a>.
\36\ Health <a href="http://IT.gov">IT.gov</a>. (2020, January 17). Federal Health
Architecture (FHA). Retrieved from <a href="https://www.healthit.gov/archive/topic/onc-hitech-programs/federal-health-architecture-fha">https://www.healthit.gov/archive/topic/onc-hitech-programs/federal-health-architecture-fha</a>.
\37\ ONC Tech Lab Standards Coordination. (2019, June 25).
Healthcare Directory. Retrieved from <a href="https://oncprojectracking.healthit.gov/wiki/display/TechLabSC/Healthcare+Directory">https://oncprojectracking.healthit.gov/wiki/display/TechLabSC/Healthcare+Directory</a>.
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Building on that work, in 2020, ONC, through the FHIR At Scale
Taskforce (FAST),\38\ identified numerous technical challenges
associated with directories, particularly related to digital
endpoints.<SUP>39 40</SUP> Specifically, FAST
[[Page 61022]]
determined that there is neither an authoritative source for digital
contact information nor a consistent method for locating such
information. ONC conducted research, stakeholder engagement, and key
technical development activities to establish the technical framework
and capabilities for an adaptable and scalable NDH.<SUP>41 42</SUP>
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\38\ FAST. (2022, March 16), FAST Home. Retrieved from <a href="https://confluence.hl7.org/display/FAST/FHIR+at+Scale+Taskforce+%28FAST%29+Home">https://confluence.hl7.org/display/FAST/FHIR+at+Scale+Taskforce+%28FAST%29+Home</a>.
\39\ FAST. (2020, December 17). Proposed Solutions Working
Document: Directory (V3). Retrieved from <a href="https://oncprojectracking.healthit.gov/wiki/display/TechLabSC/Directory%2C+Versions+and+Scale+Tiger+Team?preview=/46301216/183107855/FAST-PS-Directory%20V3_122320.docx">https://oncprojectracking.healthit.gov/wiki/display/TechLabSC/Directory%2C+Versions+and+Scale+Tiger+Team?preview=/46301216/183107855/FAST-PS-Directory%20V3_122320.docx</a>.
\40\ Endpoints provide a simple, secure, scalable, and
standards-based way for participants to send authenticated,
encrypted health information directly to known, trusted recipients
over the internet. See CMS. (2016). Health Information Exchange
(HIE) Page. Retrieved from <a href="https://nppes.cms.hhs.gov/webhelp/nppeshelp/HEALTH%20INFORMATION%20EXCHANGE.html">https://nppes.cms.hhs.gov/webhelp/nppeshelp/HEALTH%20INFORMATION%20EXCHANGE.html</a>.
\41\ ONC Tech Lab Standards Coordination. (2019, June 27).
Healthcare Directory Workshop--2019. Retrieved from <a href="https://oncprojectracking.healthit.gov/wiki/display/TechLabSC/Provider+Directory+Workshop+-+2016">https://oncprojectracking.healthit.gov/wiki/display/TechLabSC/Provider+Directory+Workshop+-+2016</a>.
\42\ ONC Tech Lab Standards Coordination. (2019, June 27). Day 1
Agenda Presentations. Retrieved from <a href="https://oncprojectracking.healthit.gov/wiki/display/TechLabSC/Day+1-+Agenda-Presentations">https://oncprojectracking.healthit.gov/wiki/display/TechLabSC/Day+1-+Agenda-Presentations</a>.
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The FAST analysis concluded that a more robust directory is the
needed long-term solution to overcome the technical barriers of using
NPPES as a digital endpoint repository. The Taskforce noted that NPPES
was not originally designed to hold, validate, and maintain digital
contact information required to ``appropriately describe the endpoints
for FHIR.'' \43\ They described that NPPES cannot sufficiently capture
the data complexity necessary to fully facilitate electronic data
exchange. For instance, provider-organization relationship information
may be necessary to determine which endpoints are relevant for
particular use cases. The Taskforce noted that other organizations that
are not currently included in NPPES, such as payers, are vital to
capture in a directory to effectively utilize digital endpoint
information.\44\ These challenges to using NPPES as a digital endpoint
directory are evidenced by the low rate of provider digital endpoint
submission. In 2021, CMS determined that 2.9 million providers still
had missing digital endpoints in NPPES.\45\ Additionally, the Taskforce
found that the majority of the Direct addresses and FHIR endpoints that
providers had submitted were invalid, a strong indication of the issues
associated with using NPPES as an endpoint repository. The Taskforce
described that there has ``historically [been a] low rate of
publication of valid Direct addresses in NPPES,'' and ``that only 4.3
percent of FHIR endpoints \46\ were valid as of 8/20/2020.'' \47\ The
FAST report concluded that for a digital endpoint directory to be
effective, the directory ``needs to be based on a broader set of
validated healthcare participants and relationships.'' \48\ This means
that such a directory must be designed to adapt to industry or market
demands for its use. FAST proposed a ``national repository for
validated information related to healthcare endpoints,'' which
described the development of a centralized directory as a critical next
step in promoting digital contact information discovery, and therefore
interoperability, across the healthcare system.\49\ FAST described that
``one authoritative national source of truth'' is needed to help
address the issues with current directory systems and identified CMS as
the potential owner of this asset.<SUP>50 51</SUP>
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\43\ FAST. (2020, December 17). Proposed Solutions Working
Document: Directory (V3). Retrieved from <a href="https://oncprojectracking.healthit.gov/wiki/display/TechLabSC/Directory%2C+Versions+and+Scale+Tiger+Team?preview=/46301216/183107855/FAST-PS-Directory%20V3_122320.docx">https://oncprojectracking.healthit.gov/wiki/display/TechLabSC/Directory%2C+Versions+and+Scale+Tiger+Team?preview=/46301216/183107855/FAST-PS-Directory%20V3_122320.docx</a>.
\44\ Ibid.
\45\ CMS. (2021, December 11). Public Reporting of Missing
Digital Contact Information. Retrieved from <a href="https://data.cms.gov/provider-compliance/public-reporting-of-missing-digital-contact-information">https://data.cms.gov/provider-compliance/public-reporting-of-missing-digital-contact-information</a>.
\46\ FHIR endpoints are just one type of endpoint collected in
NPPES and refer to a FHIR-compatible endpoint such as a FHIR URL.
Other types of endpoints used by providers are not necessarily FHIR-
compatible, such as a Direct address.
\47\ FAST. (2020, December 17). Proposed Solutions Working
Document: Directory (V3). Retrieved from <a href="https://oncprojectracking.healthit.gov/wiki/display/TechLabSC/Directory%2C+Versions+and+Scale+Tiger+Team?preview=/46301216/183107855/FAST-PS-Directory%20V3_122320.docx">https://oncprojectracking.healthit.gov/wiki/display/TechLabSC/Directory%2C+Versions+and+Scale+Tiger+Team?preview=/46301216/183107855/FAST-PS-Directory%20V3_122320.docx</a>.
\48\ Ibid.
\49\ Ibid.
\50\ Ibid.
\51\ Note, the FAST Initiative will transition from an ONC-
convened initiative into an official HL7 FHIR Accelerator in 2022.
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In May 2020, CMS published a final rule, ``Medicare and Medicaid
Programs; Patient Protection and Affordable Care Act; Interoperability
and Patient Access for Medicare Advantage Organization and Medicaid
Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP
Managed Care Entities, Issuers of Qualified Health Plans on the
Federally-Facilitated Exchanges, and Healthcare Providers'' (CMS
Interoperability and Patient Access final rule),\52\ in which we
required that, by January 1, 2021, MA organizations, Medicaid \53\ and
CHIP FFS \54\ programs, Medicaid managed care plans,\55\ and CHIP
managed care entities \56\ make standardized information about their
provider networks available through a Provider Directory API that is
conformant with technical standards finalized by ONC.<SUP>57 58</SUP>
Those Provider Directory APIs are required to be accessible via a
public-facing digital endpoint on the payer's website to ensure public
discovery and access. Payers must make all directory information
available to current and prospective enrollees and the public through
the Provider Directory API within 30 calendar days of receiving new or
updated provider directory data.
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\52\ CMS. (2020, May 1). 85 FR 25510, See page 25513. Retrieved
from <a href="https://www.federalregister.gov/d/2020-05050">https://www.federalregister.gov/d/2020-05050</a>.
\53\ We note 42 CFR 431.70 as the current regulation requiring
provider directory APIs.
\54\ We note 42 CFR 457.760 as the current regulation requiring
provider directory APIs.
\55\ We note 42 CFR 438.242(b)(6) as the current regulation
requiring provider directory APIs.
\56\ We note 42 CFR 457.1233(d), through cross-reference to
Sec. 438.242, as the current regulation requiring provider
directory APIs.
\57\ While other aspects of that rule applied to issuers of QHPs
on the FFEs, this requirement did not.
\58\ ONC. (2020, May 1). 45 CFR 170.215. Retrieved from <a href="https://www.federalregister.gov/documents/2020/05/01/2020-07419/21st-century-cures-act-interoperability-information-blocking-and-the-onc-health-it-certification">https://www.federalregister.gov/documents/2020/05/01/2020-07419/21st-century-cures-act-interoperability-information-blocking-and-the-onc-health-it-certification</a>.
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In the same final rule, CMS finalized a policy to publicly report
the names and NPIs of those providers who do not have digital contact
information included in NPPES.\59\ In December 2021, CMS published a
report of approximately 2.9 million NPIs associated with providers and
clinicians without digital contact information in NPPES,\60\ an
initiative CMS has undertaken to improve provider engagement. CMS noted
that the NPPES Missing Digital Contact Information Report will be
updated quarterly. The most recent data for the second quarter of 2022,
reported July 25, 2022, do not show any significant improvements in the
number of providers with missing digital contact information compared
to the December 2021 report.\61\ These data underscore FAST's call for
a more robust long-term digital endpoint directory solution.
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\59\ CMS. (2020, May 1). 85 FR 25510. See page 25584. Retrieved
from <a href="https://www.federalregister.gov/d/2020-05050/p-767">https://www.federalregister.gov/d/2020-05050/p-767</a>.
\60\ CMS. (2021, December 11). Public Reporting of Missing
Digital Contact Information. Retrieved from <a href="https://data.cms.gov/provider-compliance/public-reporting-of-missing-digital-contact-information">https://data.cms.gov/provider-compliance/public-reporting-of-missing-digital-contact-information</a>.
\61\ CMS. (2021, July 25). Public Reporting of Missing Digital
Contact Information. Retrieved from <a href="https://data.cms.gov/provider-compliance/public-reporting-of-missing-digital-contact-information">https://data.cms.gov/provider-compliance/public-reporting-of-missing-digital-contact-information</a>.
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In 2020, the Consolidated Appropriations Act, 2021 (CAA) (Pub. L.
116-260), Division BB, section 116 added a new section 2799A-5 to the
PHSA, section 720 to the Employee Retirement Income Security Act of
1974 (ERISA), and section 9820 to the Internal Revenue Code of 1986.
These
[[Page 61023]]
provisions require group health plans and health insurance issuers
offering group or individual health insurance coverage to publish a
provider directory and to establish a process to verify data in the
directory at least every 90 days, beginning with plan years that start
on or after January 1, 2022. Those directories must include names,
addresses, specialty, telephone numbers, and digital contact
information for healthcare providers and healthcare facilities. In
addition, the CAA added a new section 2799B-9 to the PHSA, which
requires each healthcare provider and healthcare facility to have in
place business processes to ensure the timely provision of provider
directory information to those payers.
To address part of the issue of inaccurate directory information,
the CAA established consumer protections for incorrect provider
directory information identifying a provider or facility as in-network
for an item or service. If a patient receives provider directory
information identifying a provider or healthcare facility as in-network
with regard to an item or service, and receives that item or service
from that provider or healthcare facility, and that provider or
healthcare facility is actually out-of-network, their plan or issuer
must limit cost-sharing to in-network terms that would apply to items
or services that were furnished by an in-network provider or facility,
and apply the deductible or out-of-pocket maximums as if the provider
or facility were in-network. We note that further rulemaking is
forthcoming for the provider directory requirements of that law, as
discussed in the ``Requirements Related to Surprise Billing; Part I''
interim final rule (86 FR 36872).<SUP>62 63</SUP>
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\62\ ``Requirements Related to Surprise Billing; Part I (86 FR
36872, 36876).
\63\ Interim guidance can be found at p. 7-8 of ``FAQs About
Affordable Care Act and Consolidated Appropriations Act, 2021
Implementation Part 49'' at <a href="https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-49.pdf">https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-49.pdf</a>.
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In addition to these efforts, industry stakeholders have stepped in
to try and fill this directory gap by developing large commercial
digital endpoint directories.<SUP>64 65</SUP> Although industry-
developed directories have helped facilitate communication among users,
access to their data is often fee-based, which inherently creates
barriers to use and inequity for healthcare entities that do not have
the resources or funds to buy access to these privately-owned endpoint
directories. A free and publicly available CMS-sponsored NDH could
minimize and may even eliminate this cost barrier associated with
private industry created digital endpoint directories, and ensure all
stakeholders have equal access to the relevant digital contact
information they may need to securely exchange health data.
Additionally, competing directories can lead to fragmentation and still
require providers to submit similar information to multiple directories
if information is not shared among directories. The FAST team concluded
there should be one directory that acts as a centralized data hub to
build trust, improve accuracy, and reduce the administrative burden on
providers that submit data to multiple directories.\66\ As discussed in
section III, industry stakeholders could utilize the data contained in
an NDH to populate their own directories, supplementing it with
additional data that could be beneficial for end users.
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\64\ CAQH. (2022). CAQH Endpoint Directory. Retrieved from
<a href="https://www.caqh.org/solutions/caqh-endpoint-directory">https://www.caqh.org/solutions/caqh-endpoint-directory</a>.
\65\ GlobeNewswire. (2022, March 10). CareMESH Launches
Developer Portal and APIs for its National Provider Directory.
Retrieved from <a href="https://www.globenewswire.com/news-release/2022/03/10/2401103/0/en/careMESH-Launches-Developer-Portal-and-APIs-for-its-National-Provider-Directory.html">https://www.globenewswire.com/news-release/2022/03/10/2401103/0/en/careMESH-Launches-Developer-Portal-and-APIs-for-its-National-Provider-Directory.html</a>.
\66\ FHIR at Scale Taskforce (FAST). (2020, June 1 & 15). SME
Session Summary Report. Retrieved from <a href="https://oncprojectracking.healthit.gov/wiki/display/TechLabSC/FAST+Proposed+Solutions+-+Subject+Matter+Expert+%28SME%29+Panel+Sessions?preview=/149848177/181174490/FAST-Directory%20SME%20Session%20Summary%20Report.pdf">https://oncprojectracking.healthit.gov/wiki/display/TechLabSC/FAST+Proposed+Solutions+-+Subject+Matter+Expert+%28SME%29+Panel+Sessions?preview=/149848177/181174490/FAST-Directory%20SME%20Session%20Summary%20Report.pdf</a>.
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The efforts noted previously have continued to drive improvements
to provider directories and lead the discussion on how to improve
patient access to information about healthcare services. However, the
effort required to update and maintain these numerous and varied
directories presents a significant burden across the healthcare
industry, and we continue to see challenges with data availability and
accuracy. We believe that CMS could build upon the previous work in
NPPES to help address some of these challenges by streamlining our own
data and making that data available in an enhanced form for public
use.\67\
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\67\ CMS. (2022, February 11). OBRHI FAQs. Retrieved from
https://www.cms.gov/about-cms/obrhi/
faqs#:~:text=Digital%20contact%20information%2C%20also%20known,truste
d%20recipients%20over%20the%20internet.
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III. National Directory of Healthcare Providers & Services Concept and
Perceived Benefits
A. National Directory of Healthcare Providers & Services Concept and
Perceived Benefits
A centralized, validated NDH could help to alleviate current
directory challenges by acting as a ``centralized data hub'' for
healthcare directory information. By consolidating data into one source
and reducing the number of places directory information must be
maintained, an NDH could reduce the overall burden of keeping
healthcare directory data up-to-date and accurate. For example,
currently, when a provider changes their office location, that provider
must update at least two separate CMS systems, NPPES and the Medicare
Provider Enrollment, Chain, and Ownership System (PECOS), as well as an
average of 20 separate payers' directories per physician practice.\68\
With the establishment of an NDH, that provider may be able to update
their information one time, through a single point of entry in an NDH,
which would make that data available not only to CMS, but also publicly
available for other payers and developers to utilize in their own
directories. We believe that providers and their staff would be more
likely to keep a single NDH updated, and verify it more frequently,
thus improving accuracy within an NDH, CMS systems, and in payers'
directories.
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\68\ CAQH. (2019, November 13). CAQH Survey: Maintaining
Provider Directories Costs US Physician Practices 2.76 Billion
Annually. Retrieved from <a href="https://www.caqh.org/about/press-release/caqh-survey-maintaining-provider-directories-costs-us-physician-practices-276">https://www.caqh.org/about/press-release/caqh-survey-maintaining-provider-directories-costs-us-physician-practices-276</a>.
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A core requirement of an NDH would be the capability to validate
and verify submitted information. In the context of an NDH, validation
and verification can refer to separate but related processes. First, it
is important to validate that the format of submitted data meets the
required standards. This could be done, for example, by checking for
the existence of required data elements, that those data elements are
in the appropriate format, that references to existing resources are
correct, and that any codes are from appropriate value sets. Second, it
is important to verify the accuracy of data against a primary source.
For example, a digital endpoint could be verified by sending a secure
message to that endpoint asking the provider to complete verification
through some action. We do not expect that all data elements would
require the same level of validation and verification. As part of
initial phases of NDH planning and development, CMS would assess
possible verification methods and sources. Through this RFI, we hope to
receive comments on this topic that could inform that assessment.
To support the ``centralized data hub'' concept, and improve
directory function, CMS seeks feedback on potentially establishing an
NDH that would overlay existing CMS systems that have directory-like
functions,
[[Page 61024]]
consolidate the data within them, and provide a single point of entry
for providers to streamline workflows. We also believe that CMS could
reduce the burden on providers and payers by building this directory
using the most up-to-date technology, leveraging FHIR APIs. FHIR APIs
would allow external stakeholders to pull data from an NDH to use as a
data source for their own directories, thus avoiding duplicative data
collection efforts. We note that in this use case example, the payers
pulling provider data from an NDH would be responsible for verifying
their own list of network providers.
Using a FHIR API, stakeholders could access and use NDH data to
support a variety of use cases. Industry would be able to transform the
data for purposes beyond what a public-facing CMS portal would be able
to provide, and present it in a customized format for consumers,
commercial, or operational use. We envision the following as other
potential use cases for a FHIR API-enabled NDH:
<bullet> A patient or consumer could use an NDH directly, or
through an app of their choosing that connects to an NDH via a FHIR
API, to locate a provider.
<bullet> To support interoperability, a provider could connect to
an NDH through the FHIR API to request the digital endpoint a
particular payer uses to receive prior authorization requests. Once
returned by an NDH, the provider's electronic health record (EHR) or
practice management system could use that digital contact information
to direct a prior authorization request to the appropriate payer.
<bullet> A payer (such as an MA organization, a private insurer, or
state Medicaid agency) could use an NDH, via a FHIR API, to update its
own provider directory with the latest information. This would allow
the payer to present a provider directory without having to bear the
burden of collecting data that is already available through an NDH from
individual providers. The providers would also experience less burden
because they would only need to update data in an NDH, and not multiple
payer-specific directories. We note that payers would still be required
to verify the accuracy of their network information to ensure that the
provider directory is accurate.
We recognize that widespread adoption of, and trust in, an NDH
would be necessary to fulfill this role as a ``centralized data hub''
for directory data. Without up-to-date, useful, and comprehensive
directory data, an NDH would not be able to address existing healthcare
directory challenges. We seek feedback on both positive and negative
incentives that could be put into place to encourage widespread NDH
use. These incentives may be for providers to update and maintain data
and/or for payers to use the data from an NDH rather than requiring
duplicative submissions from providers. We want to understand what
incentives, programs, or policies might promote timely and accurate
data reporting, as well as robust NDH usage by stakeholders.
We note that we previously requested comments, summarized in the
2020 CMS Interoperability and Patient Access final rule,\69\ regarding
policies that we could implement to encourage providers to update their
digital contact information in NPPES. Several commenters suggested
incorporating a requirement to have up-to-date digital contact
information in NPPES into the Merit-based Incentive Payment System
(MIPS) program. We acknowledge a logical relationship with the
Promoting Interoperability category of MIPS and continue to explore
that avenue. However, we also realize the limitations of that
possibility, as only certain types of clinicians who see Medicare
patients are eligible to participate in MIPS and many Medicare
providers participate in alternative programs.
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\69\ CMS. (2020, May 1). 85 FR 25510. See pages 25581-84.
Retrieved from <a href="https://www.federalregister.gov/d/2020-05050">https://www.federalregister.gov/d/2020-05050</a>.
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We understand that it would be critical to allow listed entities,
particularly providers, to delegate or authorize other individuals,
either in their organization or intermediary organizations, to submit
directory data on their behalf to reduce burden and ensure that data
submission is feasible, timely, and accurate. We are using the term
``listed entities'' to refer to individuals and groups whose data could
be available in an NDH. We want to understand current industry best
practices for delegating authority and aspects of this functionality
that could be used with an NDH.
B. Interactions With Current CMS Data Systems and Impacts to Business
Processes
Integrating an NDH with current CMS-maintained systems, such as
NPPES, PECOS, and Care Compare, could streamline data collection by
acting as the single entry-point for listed entities to update their
data across multiple CMS systems. Such data interactions could address
provider data accuracy and consistency issues among CMS systems.\70\
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\70\ Levinson, D. R. (2013, May). Improvements Needed to Ensure
Provider Enumeration and Medicare Enrollment Data are Accurate,
Complete, and Consistent. Retrieved from <a href="https://oig.hhs.gov/oei/reports/oei-07-09-00440.pdf">https://oig.hhs.gov/oei/reports/oei-07-09-00440.pdf</a>.
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Examples of existing CMS data collection and reporting systems that
an NDH could interface with to streamline data processes include:
<bullet> NPPES: Developed to assign NPIs to healthcare
providers.\71\ Once an NPI is assigned, CMS, through NPPES, publishes
the parts of the NPI record that have public relevance, including the
provider's name, location, phone number, gender, specialty (taxonomy),
practice address, and other identifiers for public use.\72\ Authorized
under the Health Insurance Portability and Accountability Act of 1996
(HIPAA) (section 1173(b) of the Act and at 45 CFR 160.103, 162.402, and
162.408 of the regulations).
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\71\ CMS. NPPES. Retrieved from <a href="https://nppes.cms.hhs.gov/#/">https://nppes.cms.hhs.gov/#/</a>.
\72\ CMS. NPPES NPI Registry. Retrieved from <a href="https://npiregistry.cms.hhs.gov/">https://npiregistry.cms.hhs.gov/</a>.
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<bullet> PECOS: Supports the Medicare provider and supplier
enrollment process. Registered providers and suppliers use PECOS to
securely submit and manage their Medicare enrollment and revalidation
processes. This system and its information attestation workflows are
integral to program integrity prevention, investigation, and
enforcement activities. We note that PECOS data are not publicly
available. Rather, the system only contains information on Medicare
providers and suppliers, and updates are limited by Medicare enrollment
requirements. Authorized under sections 1102(a), 1128, 1814(a),
1815(a), 1833(e), 1871, and 1886(d)(5)(F) of the Act; 1842(r); section
1124(a)(1), and 1124A, section 4313, as amended, of the BBA of 1997;
and section 31001(I) (31 U.S.C. 7701) of the Debt Collection
Improvement Act of 1996 (DCIA) (Pub. L. 104-134), as amended.
<bullet> Medicare Care Compare: Public, consumer-facing directory
containing contact and quality information on certain types of Medicare
providers, suppliers, and provider organizations, including doctors,
clinicians, hospitals, nursing homes, home health and hospice care,
inpatient rehabilitation facilities, long-term care hospitals, and
dialysis facilities. Care Compare data are populated from several data
sources, including PECOS, NPPES and CMS quality reporting programs.
Care Compare allows for comparison of Medicare providers and suppliers.
We are authorized to collect and publicly report the following:
++ Certain physician quality data, in part, by section 10331(a)(1)
of the Affordable Care Act, section 104(e) of the Medicare Access and
CHIP
[[Page 61025]]
Reauthorization Act of 2015 (MACRA) and section 1848 of the Act.
++ Certain hospital quality data under section 501(b) of MMA of
2003 and section 5001(a) of the Deficit Reduction Act of 2005 and
section 1886 of the Act.
++ Certain hospice quality data under section 3004 of the
Affordable Care Act and section 1814 of the Act.
++ Certain long-term care hospital quality data under section 3004
of the Affordable Care Act and section 1886(m)(5) of the Act.
++ Certain inpatient rehabilitation facility quality data under
section 3004 of the Affordable Care Act and section 1886(j)(7) of the
Act.
++ Certain home health quality data under section 1895(b)(3)(B)(v)
of the Act.
++ Certain dialysis facility quality data under section 1881 of the
Act and required by 42 CFR 405.2100 through 405.2171 (now at 42 CFR
414.330, 488.60, and 494.100 through 494.180).
++ Certain skilled nursing home quality data under section
1888(e)(6) of the Act, modified under the Improving Medicare Post-Acute
Care Transformation (IMPACT) Act of 2014.
We note that we are not specifically requesting comment on
replacing any of these or other CMS systems with an NDH. Rather, we
believe that an NDH could be a tool that works in combination with
these systems to streamline and improve the processes for collecting,
maintaining, and presenting information in a more user-friendly manner.
As discussed earlier, we envision that an NDH would create efficiencies
by serving as a ``centralized data hub'' that would feed data to these
other systems to use within their intended functions. An NDH built with
modern data exchange capabilities, such as APIs, could share data with
other CMS systems in real-time, improving data accuracy across CMS
while eliminating the need for stakeholders to update information in
multiple places.
Within these systems, CMS collects various demographic, contact,
and healthcare practice data from or about many provider types and
payer entities. These systems, in combination with other data systems
that CMS maintains, have been established over time to perform their
specific roles and in total contain a significant breadth of provider
and payer data. By strengthening current efforts to streamline data
processes, CMS could further improve the value and usability of its
data. For example, linking provider contact information and quality
data into one streamlined CMS resource could help consumers identify,
compare, and locate providers who meet their specific needs and
preferences. We also note that linking this information may be valuable
for providers and payers participating in value-based payment models.
We seek feedback on how we could combine these datasets into a single
interface to be able to display more complex information, such as a
clinician's relationship with hospitals or nursing facilities. This
data aggregation may better support patients when choosing a healthcare
facility or help providers locate one another for improved data
exchange and care coordination.
We have increasingly emphasized improving the interoperability of
data collected across our systems. As we have discussed, we believe
existing directory-like information within CMS' systems could benefit
from the operational efficiencies and streamlined effort of an NDH. We
seek comment, prompted by the questions below, on various aspects that
we should consider as we evaluate the feasibility, scope, and
functionality of an NDH.
C. Comment Solicitation
We solicit comments on the following topics related to the
establishment of an NDH:
<bullet> What benefits and challenges might arise while integrating
data from CMS systems (such as NPPES, PECOS, and Medicare Care Compare)
into an NDH? What data elements from each of these systems would be
important to include in an NDH versus only being available directly
from the system in question?
<bullet> Are there other CMS, HHS (for example, HPMS, Title X
family planning clinic locator, ACL's Eldercare Resource Locator,
SAMHSA's Behavioral Health Resource Locator, HRSA's National
Practitioner Data Bank, or HRSA's Get Health Care), or federal systems
with which an NDH could or should interface to exchange directory data?
++ What are these systems, how should an NDH interact with these
systems, and for what purpose?
++ What data elements from each of these systems would be important
to include in an NDH?
<bullet> Are there systems at the state or local level that would
be beneficial for an NDH to interact with, such as those for licensing,
credentialing, Medicaid provider enrollment, emergency response (for
example, the Patient Unified Lookup System for Emergencies (PULSE)
\73\) or public health?
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\73\ ONC. (2022, March 4). Patient Unified Lookup System for
Emergencies (PULSE). Retrieved from <a href="https://www.healthit.gov/topic/health-it-health-care-settings/public-health/patient-unified-lookup-system-for-emergencies-pulse">https://www.healthit.gov/topic/health-it-health-care-settings/public-health/patient-unified-lookup-system-for-emergencies-pulse</a>.
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++ What data elements would be beneficial to include in an NDH for
interaction with state or local systems, including State-based
Exchanges or existing state-level provider directories?
<bullet> Added by the Cures Act, Section 3001(c)(9)(D)(i) of the
PHSA requires ONC to create, annually update, and publish on its
website a ``list of the health information networks that have adopted
the common agreement and are capable of trusted exchange pursuant to
the common agreement.'' Are there beneficial ways an NDH could
interface with such a list or provide additional information that may
be useful, such as a directory of services? Are there use cases for
integrating such health information network data in an NDH?
<bullet> What types of data should be publicly accessible from an
NDH (either from a consumer-facing CMS website or via an API) and what
types of data would be helpful for CMS to collect for only internal use
(such as for program integrity purposes or for provider privacy)?
<bullet> Are there particular data elements that CMS currently
collects or should collect as part of an NDH that we should not make
publicly available, regardless of usefulness to consumers, due to its
proprietary nature? To the extent that an NDH might collect proprietary
data from various entities, what privacy protections should be in place
for these data?
<bullet> We want an NDH to support health equity goals throughout
the healthcare system. What listed entities, data elements, or NDH
functionalities would help underserved populations receive healthcare
services? What considerations would be relevant to address equity
issues during the planning, development, or implementation of an NDH?
<bullet> How could NDH use within the healthcare industry be
incentivized? How could CMS incentivize other organizations, such as
payers, health systems, and public health entities to engage with an
NDH?
<bullet> How could CMS evaluate whether an NDH achieves the
targeted outcomes for its end users (for example, that it saves
providers time or that it simplifies patients' ability to find care)?
We solicit comments on an NDH concept and high-level functionality:
<bullet> Would an NDH as described provide the benefits outlined
previously?
<bullet> Would an NDH as described reduce the directory data
submission burden on providers?
[[Page 61026]]
<bullet> How could a centralized source for digital contact
information benefit providers, payers, and other stakeholders?
<bullet> We have heard interest in including additional healthcare-
related entities and provider types beyond physicians in an NDH-type
directory beyond those providers included in current CMS systems or
typical payers' directories? For example, should an NDH include allied
health professionals, post-acute care providers, dentists, emergency
medical services, nurse practitioners, physician assistants, certified
nurse midwives, providers of dental, vision, and hearing care,
behavioral health providers (psychiatrists, clinical psychologists,
licensed professional counselors, licensed clinical social workers,
etc.), suppliers, pharmacies, public health entities, community
organizations, nursing facilities, suppliers of durable medical
equipment or health information networks? We specifically request
comment on entities that may not currently be included in CMS systems.
++ For what use cases should these various entities be included?
<bullet> Are there NDH use cases to address social drivers and/or
determinants of health? If so, what are they? Are there other entities,
relationships, or data elements that would be helpful to include in an
NDH to help address the social drivers and/or determinants of health
(for example, community-based organizations that provide housing-
related services and supports, non-medical transportation, home-
delivered meals, educational services, employment, community
integration and social supports, or case management)? What types of
entities or data elements relating to social drivers and/or
determinants of health should not be included in an NDH?
<bullet> What provider or entity data elements would be helpful to
include in an NDH for use cases relating to patient access and consumer
choice (for example, finding providers or comparing networks)?
++ What data elements would be useful to include in an NDH to help
patients locate providers who meet their specific needs and
preferences?
++ Would it be helpful to include data elements such as provider
languages spoken other than English, specific office accessibility
features for patients with disabilities and/or limited mobility,
accessible examination or medical diagnostic equipment, or a provider's
cultural competencies, such as the National Committee for Quality
Assurance's Health Equity accreditation (though we note that these data
elements may be difficult to verify in some cases)?
<bullet> What provider or entity data elements would be helpful to
include in an NDH for use cases relating to care coordination and
essential business transactions (for example, prior authorization
requests, referrals, public health reporting)?
++ What specific health information exchange or use cases would be
important for an NDH to support?
++ Are there other types of data transactions or use cases beyond
those already discussed that would be helpful for an NDH to support?
++ Are there additional data elements beyond those already
discussed that would be useful for these use cases?
++ Beyond using FHIR APIs, what strategic approaches should be
taken to ensure that directory data are interoperable?
<bullet> The COVID-19 pandemic has highlighted a need for public
health systems to be better connected to providers and with each other.
Would there be benefits to including public health entities in an NDH?
++ What public health use cases would it be helpful for an NDH to
support (for example, facilitating digital contact endpoint discovery
for public health reporting, or to provide additional data for public
health entities' analytics)?
++ What data elements would be useful to collect from these
entities to advance public health goals?
<bullet> Understanding that individuals often move between public
and commercial health insurance coverage, what strategies could CMS
pursue to ensure that an NDH is comprehensive both nationwide and
market-wide?
++ Are there specific strategies, technical solutions, or policies
CMS could pursue to encourage participation in an NDH by group health
plans and health insurance issuers offering group or individual health
insurance coverage for programs or product lines not currently under
CMS' purview?
<bullet> Are there use cases for which it would be helpful for an
NDH to support state and local governments? For example, are there
specific types of providers, data elements, or technical requirements
that would allow for infrastructure planning support, resource
allocation, policy analysis, research, evaluation, emergency
preparedness and response (such as PULSE), care coordination, planning,
establishing partnerships, and determining service gaps?
++ How should CMS work with states to align federal and state
policies to allow all parties to effectively use an NDH?
<bullet> Are there use cases for which an NDH could be used to help
prevent fraud, waste, abuse, improper payments, or privacy breaches?
Conversely, are there any concerns that an NDH, as described, could
increase the possibility of those outcomes, and, if so, what actions
could be taken to mitigate that risk?
<bullet> What specific functionality or use cases, including any
not discussed here, would it be helpful for CMS to consider developing
within an NDH? What types of data elements would need to be included
(or excluded) to support these use cases (for example, licensing,
certification, and credentialing)?
<bullet> Beyond identifying providers associated with specific
organizations, and organizations that may be under the umbrella of a
single health system, what other relationships would be important to
capture and why?
<bullet> We have received feedback that individual providers may
not use their individual digital endpoints in many cases where the
communications involve patients receiving institutional care. How can
we associate group- or practice-level digital contact information with
appropriate providers to ensure that data get to the right place?
<bullet> What types of entities should be encouraged to use data
from an NDH? For what purposes and why?
<bullet> What are some of the functions or features of current
provider directories that work particularly well?
<bullet> What are some of the lessons learned or mistakes to avoid
from current provider directories of which we should be aware?
We solicit comments on key considerations related to data
submission and maintenance for potential NDH development:
<bullet> What policy or operational factors should be considered
for new data collection interfaces as part of a single point of entry?
<bullet> How can data be collected, updated, verified, and
maintained without creating or increasing burden on providers and
others who could contribute data to an NDH, especially for under-
resourced or understaffed facilities?
<bullet> What are barriers to updating directory data in current
systems that could be addressed with an NDH?
<bullet> What are current and potential best practices regarding
the frequency of directory data updates?
<bullet> What specific strategies, technical solutions, or policies
could CMS implement to facilitate timely and accurate directory data
updates? How
[[Page 61027]]
could consistent and accurate NDH data submission be incentivized
within the healthcare industry?
<bullet> How should duplicate information or conflicting
information reported from different sources be resolved to balance the
reporting burden versus confidence in data accuracy?
<bullet> The Healthcare Directory initiative and FAST both
identified validation and verification as important functions of a
centralized directory. What data types or data sources are important to
verify (for example, provider endpoint information, provider
credentialing) versus relying on self-reported information? Are there
specific recommendations for verifying specific data elements?
<bullet> What use cases would benefit from data being verified and
what sort of assurances would be necessary for trust and reliance on
those data?
<bullet> Are there use cases where an NDH could provide data that
has already been verified to reduce that burden on payers or other
entities and, if so, how could that be achieved?
<bullet> What concerns might listed entities have about submitting
data to an NDH? We solicit comments on provider delegation of authority
to submit data on a provider's behalf:
<bullet> Outside of CMS, what mechanisms, standards, or processes
are currently used to enable provider delegation of authority to submit
data?
<bullet> What challenges, if any, occur in the processes for
delegating authority to submit data on behalf of providers or in the
processes for submitting directory data on behalf of providers?
<bullet> What specific strategies, technical solutions, or policies
could be implemented to enable delegation of authority to submit data
to an NDH?
<bullet> Should CMS consider including role-based access management
to submit provider data to an NDH, and, if so, what kind of role-based
access management?
<bullet> Are there entities that currently exist that would be
helpful to serve as intermediaries for bulk data verification and
upload or submission to an NDH? If so, are there existing models that
demonstrate how this can be done (for instance, the verifications
performed through the Federal Data Services Hub)?
<bullet> How do intermediaries currently perform bulk data
verification and upload or submission to provider directories?
IV. Technical Framework for an NDH
A. Overview
The technical approach to establishing an NDH could leverage the
extensive work the federal government has already done, in
collaboration with industry stakeholders and standards development
organizations, to develop healthcare directory information exchange
standards. CMS could build on existing work to develop FHIR-based
standards for healthcare directories. For years, ONC has collaborated
with HL7, an ANSI-accredited standards development organization, to
support the scalability and industry adoption of FHIR standards for use
in a healthcare directory.\74\ \75\ Through an industry-led and
consensus-based workgroup process, HL7 publishes various technical
architecture standards, known as Implementation Guides (IGs). In 2016,
HL7, in cooperation with the ONC and FHA Healthcare Directory
initiative, developed and published the Validated Healthcare Directory
(VHDir) IG. The VHDir IG was developed to describe the technical design
considerations for collecting, validating, verifying, and exchanging
data from a healthcare directory. The IG also provides technical
guidance for a FHIR API for accessing data from a validated healthcare
directory and could be used, for example, for provider credentialing
and privileging.\76\ \77\ Building on this initial work, FAST has
collaborated with HL7's Patient Administration Work Group to develop
and maintain new FHIR IGs to further describe data attestation and
verification processes, as well as a standard API for local directories
to make verified data available to stakeholders: the National Directory
Endpoint Query IG, the National Directory Exchange IG, and the National
Directory Attestation and Validation IG.\78\
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\74\ ONC. (2021, April). What is HL7 FHIR? Retrieved from
<a href="https://www.healthit.gov/topic/standards-technology/standards/fhir-fact-sheets">https://www.healthit.gov/topic/standards-technology/standards/fhir-fact-sheets</a>.
\75\ Hadassah, G. & Marcelonis, D. (2022, May 20). National
Healthcare Directory. Retrieved from <a href="https://confluence.hl7.org/display/PA/National+Healthcare+Directory">https://confluence.hl7.org/display/PA/National+Healthcare+Directory</a>.
\76\ ONC Tech Lab Standards Coordination. (2019, June 25).
Healthcare Directory. Retrieved from <a href="https://oncprojectracking.healthit.gov/wiki/display/TechLabSC/Healthcare+Directory">https://oncprojectracking.healthit.gov/wiki/display/TechLabSC/Healthcare+Directory</a>.
\77\ HL7. (2022). Validated Healthcare Directory. Retrieved from
<a href="http://build.fhir.org/ig/HL7/VhDir/index.html">http://build.fhir.org/ig/HL7/VhDir/index.html</a>.
\78\ Hadassah, G. & Marcelonis, D. (2022, May 20). National
Healthcare Directory. Retrieved from <a href="https://confluence.hl7.org/display/PA/National+Healthcare+Directory">https://confluence.hl7.org/display/PA/National+Healthcare+Directory</a>.
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Additionally, CMS could build on work done by FAST. FAST identified
numerous technical challenges associated with directories, particularly
related to digital contact information, and conducted research,
stakeholder engagement, and key technical development activities to
establish the framework and capabilities needed for a scalable NDH.\79\
\80\ In their proposed directory technical solutions document, FAST
also identified CMS as the appropriate potential maintainer of an
NDH.\81\
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\79\ FAST. (2020, December 17). Proposed Solutions Working
Document: Directory (V3). Retrieved from <a href="https://oncprojectracking.healthit.gov/wiki/display/TechLabSC/Directory%2C+Versions+and+Scale+Tiger+Team?preview=/46301216/183107855/FAST-PS-Directory%20V3_122320.docx">https://oncprojectracking.healthit.gov/wiki/display/TechLabSC/Directory%2C+Versions+and+Scale+Tiger+Team?preview=/46301216/183107855/FAST-PS-Directory%20V3_122320.docx</a>.
\80\ ONC Tech Lab Standards Coordination. (2022, April 1). FHIR
at Scale Taskforce (FAST). Retrieved from <a href="https://oncprojectracking.healthit.gov/wiki/pages/viewpage.action?pageId=43614268">https://oncprojectracking.healthit.gov/wiki/pages/viewpage.action?pageId=43614268</a>.
\81\ FAST. (2020, December 17). Proposed Solutions Working
Document: Directory (V3). Page 13. Retrieved from <a href="https://oncprojectracking.healthit.gov/wiki/display/TechLabSC/Directory%2C+Versions+and+Scale+Tiger+Team?preview=/46301216/183107855/FAST-PS-Directory%20V3_122320.docx">https://oncprojectracking.healthit.gov/wiki/display/TechLabSC/Directory%2C+Versions+and+Scale+Tiger+Team?preview=/46301216/183107855/FAST-PS-Directory%20V3_122320.docx</a>.
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Given these existing efforts to establish FHIR-based standards for
healthcare directory information exchange, CMS could leverage this work
to serve as the technical foundation on which to develop a FHIR API-
enabled NDH. Additionally, using FHIR standards would help align an NDH
with the technical standards at 45 CFR 170.215 finalized by ONC in the
21st Century Cures Act: Interoperability, Information Blocking, and the
ONC Health IT Certification Program final rule (85 FR 25642).
B. Comment Solicitation
We are soliciting comments on technical considerations for a
potential NDH:
<bullet> In addition to FHIR, what technical standards are
currently used or show promise to exchange directory data?
<bullet> What technical standards should an NDH support?
<bullet> What work related to developing FHIR standards for an NDH,
such as building and refining IGs, still needs to be completed?
<bullet> How could CMS and ONC ensure that an NDH improves
interoperability by promoting the adoption of TEFCA and supporting
participating health information networks and healthcare entities? What
are key opportunities for an NDH and TEFCA to work together in a
mutually beneficial fashion?
<bullet> Are there use cases for providers accessing an NDH through
their EHRs and, if so, what are the technical requirements?
<bullet> Are there use cases for individuals accessing an NDH
through a patient-facing health app and, if so, what are the technical
requirements?
<bullet> What security standards should be used to support an NDH?
<bullet> How should authentication and access to an NDH be managed
for data
[[Page 61028]]
submission? Should authentication and access processes vary based on
the type of data being submitted, and if so, how?
<bullet> What other technical considerations should CMS be aware
of?
V. Phased Approach to Implementation
A. Overview
The primary goal of an NDH would be to serve as a ``centralized
data hub'' for accurate directory information in the healthcare market.
To achieve that goal, CMS is seeking comments on a potential phased
approach to establishing an NDH, in alignment with IT industry best
practices. We would assess our statutory authorities to establish an
NDH and take appropriate action. The initial phases of implementation
would focus on consolidating and verifying existing data, building
trust, and gaining industry buy-in. Subsequent phases would build on
that foundation by incorporating additional data elements, listed
entity types, and functionality while maintaining trust in the
integrity of the system and data. This phased approach would allow CMS
to gather consumer and industry input while focusing on scalability,
data validity and governance, ethics, and equity for needed agency
action or NDH development.
B. Comment Solicitation
We are soliciting comments on the feasibility of a phased approach
to implementation and potential opportunities to build stakeholder
trust and adoption along the way:
<bullet> What entities or stakeholders should participate in the
development of an NDH, and what involvement should they have?
<bullet> What stakeholders could have valuable feedback in the
scoping and early implementation processes to ensure viability of an
NDH and sufficient uptake across the healthcare industry?
<bullet> What functionality would constitute a minimum viable
product?
<bullet> What specific strategies, technical solutions, or policies
could CMS employ to best engage stakeholders and build trust throughout
the development process?
<bullet> What use cases should be prioritized in a phased
development and implementation process for immediate impact and burden
reduction?
<bullet> What types of entities and data categories should be
prioritized in a phased development and implementation process for
immediate impact and burden reduction?
<bullet> How could human-centered design, including equity-centered
design, principles be used to optimize the usability of an NDH?
<bullet> What issues should CMS anticipate throughout an NDH system
development life cycle?
++ Development (for example: timelines, technologies).
++ Implementation (for example: phased roll out, obtaining buy-in).
++ Operations (for example: updating content, access, and
security).
++ Maintenance (for example: updating technologies, ensuring data
accuracy).
VI. Prerequisites and CMS Actions To Address Challenges and Risks
A. Overview
We are aware of the many prerequisites, risks, and challenges
associated with the implementation of such a directory and would
consider these throughout the development process. As noted previously,
the federal government has led numerous technical efforts that would
help inform the planning and development of an NDH. Challenges
associated with establishing an NDH include, but are not limited to,
project planning and scoping, stakeholder and collaborator engagement,
development risks, use of existing identifiers (for example, NPI or
TIN), data publication, system maintenance, and stakeholder adoption.
B. Comment Solicitation
We are soliciting comments on risks, challenges, and prerequisites
associated with implementing such a directory:
<bullet> What technical or policy prerequisites would need to be
met prior to developing an NDH?
<bullet> What specific risks or challenges should be anticipated
throughout the system development life cycle of an NDH? How can these
risks and challenges be minimized?
<bullet> What are the most promising efforts that exist to date in
resolving healthcare directory challenges? How could CMS best
incorporate outputs from these efforts into the requirements for an
NDH? Which gaps remain that are not being addressed by existing
efforts?
VII. Information Collection Requirements
Please note, this is a request for information (RFI) only. In
accordance with the implementing regulations of the Paperwork Reduction
Act of 1995 (PRA), specifically 5 CFR 1320.3(h)(4), this general
solicitation is exempt from the PRA. Facts or opinions submitted in
response to general solicitations of comments from the public,
published in the Federal Register or other publications, regardless of
the form or format thereof, provided that no person is required to
supply specific information pertaining to the commenter, other than
that necessary for self-identification, as a condition of the agency's
full consideration, are not generally considered information
collections and therefore not subject to the PRA.
This RFI is issued solely for information and planning purposes; it
does not constitute a Request for Proposal (RFP), applications,
proposal abstracts, or quotations. This RFI does not commit the U.S.
Government to contract for any supplies or services or make a grant
award. Further, CMS is not seeking proposals through this RFI and will
not accept unsolicited proposals. Responders are advised that the U.S.
Government will not pay for any information or administrative costs
incurred in response to this RFI; all costs associated with responding
to this RFI will be solely at the interested party's expense. Not
responding to this RFI does not preclude participation in any future
procurement, if conducted. It is the responsibility of the potential
responders to monitor this RFI announcement for additional information
pertaining to this request. Please note that CMS will not respond to
questions about the policy issues raised in this RFI. CMS may or may
not choose to contact individual responders. Such communications would
only serve to further clarify written responses. Contractor support
personnel may be used to review RFI responses. Responses to this notice
are not offers and cannot be accepted by the U.S. Government to form a
binding contract or issue a grant. Information obtained as a result of
this RFI may be used by the U.S. Government for program planning on a
non-attribution basis. Respondents should not include any information
that might be considered proprietary or confidential. This RFI should
not be construed as a commitment or authorization to incur cost for
which reimbursement would be required or sought. All submissions become
U.S. Government property and will not be returned. CMS may publicly
post the comments received, or a summary thereof.
Chiquita Brooks-LaSure, Administrator of the Centers for Medicare &
Medicaid Services, approved this document on September 28, 2022.
[[Page 61029]]
Dated: October 3, 2022.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2022-21904 Filed 10-5-22; 8:45 am]
BILLING CODE 4120-01-P
</pre></body>
</html>Indexed from Federal Register on October 7, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.