CMS-10877 Business Agreement BY 2024

OMB Control #: 0938-NEW
Expiration Date: XX/XX/20XX

ENHANCED DIRECT ENROLLMENT AGREEMENT BETWEEN ENHANCED
DIRECT ENROLLMENT ENTITY AND THE CENTERS FOR MEDICARE &
MEDICAID SERVICES FOR THE INDIVIDUAL MARKET FEDERALLYFACILITATED EXCHANGES AND STATE-BASED EXCHANGES ON THE FEDERAL
PLATFORM
THIS ENHANCED DIRECT ENROLLMENT AGREEMENT (“Agreement”) is entered into by
and between THE CENTERS FOR MEDICARE & MEDICAID SERVICES (“CMS”), as the
Party (as defined below) responsible for the management and oversight of the Federallyfacilitated Exchanges (“FFEs”), also referred to as “Federally-facilitated Marketplaces” or
“FFMs” and the operation of the federal eligibility and enrollment platform, which includes the
CMS Data Services Hub (“Hub”), relied upon by certain State-based Exchanges (SBEs) for their
eligibility and enrollment functions (including State-based Exchanges on the Federal Platform
(SBE-FPs)), and ________________________________________________________________
(hereinafter referred to as “Enhanced Direct Enrollment [EDE] Entity”), which uses a non-FFE
Internet website in accordance with 45 C.F.R. §§ 155.220(c), 155.221, 156.265, and/or 156.1230
to assist Consumers, Applicants, Qualified Individuals, and Enrollees—or these individuals' legal
representatives or Authorized Representatives in applying for Advance Payments of the Premium
Tax Credit (“APTC”) and Cost-sharing Reductions (“CSRs”); applying for enrollment in
Qualified Health Plans (“QHPs”); completing enrollment in QHPs; and providing related
Customer Service. CMS and EDE Entity are hereinafter referred to as the “Party” or, collectively,
as the “Parties.”
WHEREAS:
Section 1312(e) of the Affordable Care Act (“ACA”) provides that the Secretary of the
U.S. Department of Health & Human Services (“HHS”) shall establish procedures that
permit Agents and Brokers to enroll Qualified Individuals in QHPs through an Exchange,
and to assist individuals in applying for APTC and CSRs, to the extent allowed by States.
To participate in the FFEs or SBE-FPs, Agents and Brokers, including Web-brokers,
must complete all applicable registration and training requirements under 45 C.F.R. §
155.220.
Section 1301(a) of the ACA provides that QHPs are health plans that are certified by an
Exchange and, among other things, comply with the regulations developed by the HHS
under Section 1321(a) of the ACA and other requirements that an applicable Exchange
may establish.
To facilitate the eligibility determination and enrollment processes, CMS will provide
centralized and standardized business and technical services (“Hub Web Services”)
through application programming interfaces (“APIs”) to EDE Entity that will enable EDE
Entity to host application, enrollment, and post-enrollment services on EDE Entity’s own
website. The APIs will enable the secure transmission of key eligibility and enrollment
information between CMS and EDE Entity.
To facilitate the operation of the FFEs and SBE-FPs, CMS desires to: (a) allow EDE
Entity to create, collect, disclose, access, maintain, store, and use Personally Identifiable
PRA DISCLOSURE: According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it
displays a valid OMB control number. The valid OMB control number for this information collection is 0938-NEW, expiration date is XX/XX/20XX. The
time required to complete this information collection is estimated to take up to 56,290 hours annually for all direct enrollment entities. If you have
comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn:
PRA Reports Clearance Officer, Mail Stop C4-26-05, Baltimore, Maryland 21244-1850. ****CMS Disclosure**** Please do not send applications, claims,
payments, medical records or any documents containing sensitive information to the PRA Reports Clearance Office. Please note that any correspondence not
pertaining to the information collection burden approved under the associated OMB control number listed on this form will not be reviewed, forwarded, or
retained. If you have questions or concerns regarding where to submit your documents, please contact Brittany Cain at Brittany.Cain@cms.hhs.gov.

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Information (“PII”) it receives directly from CMS and from Consumers, Applicants,
Qualified Individuals, and Enrollees through EDE Entity’s website—or from these
individuals’ legal representatives or Authorized Representatives—for the sole purpose of
performing activities that are necessary to carry out functions that the ACA and its
implementing regulations permit EDE Entity to perform; and (b) allow EDE Entity to
provide such PII and other Consumer, Applicant, Qualified Individual, and Enrollee
information to the FFEs and SBE-FPs through specific APIs to be provided by CMS.
EDE Entity desires to use an EDE Environment to create, collect, disclose, access,
maintain, store, and use PII from CMS, Consumers, Applicants, Qualified Individuals,
and Enrollees—or these individuals’ legal representatives or Authorized
Representatives—to perform the Authorized Functions described in Section III.a of this
Agreement.
45 C.F.R. § 155.260(b) provides that an Exchange must, among other things, require as a
condition of contract or agreement that Non-Exchange Entities comply with privacy and
security standards that are consistent with the standards in 45 C.F.R. §§ 155.260(a)(1)
through (a)(6), including being at least as protective as the standards the Exchange has
established and implemented for itself under 45 C.F.R. § 155.260(a)(3). 45 C.F.R. §
155.280 requires HHS to oversee and monitor Non-Exchange Entities for compliance
with Exchange-established privacy and security requirements.
CMS has adopted privacy and security standards with which EDE Entity must comply, as
specified in the Non-Exchange Entity System Security and Privacy Plan (“NEE SSP”) 1
and referenced in Appendix A (“Privacy and Security Standards and Implementation
Specifications for Non-Exchange Entities”), which are specifically incorporated herein.
The security and privacy controls and implementation standards documented in the NEE
SSP are established in accordance with Section 1411(g) of the ACA (42 U.S.C. §
18081(g)), the Federal Information Management Act of 2014 (“FISMA”) (44 U.S.C.
3551), and 45 C.F.R. § 155.260 and are consistent with the standards in 45 C.F.R. §§
155.260(a)(1) through (a)(6).
0F

Now, therefore, in consideration of the promises and covenants herein contained, the adequacy
of which the Parties acknowledge, the Parties agree as follows:
I.

Definitions.

Capitalized terms not otherwise specifically defined herein shall have the meaning set forth in
the attached Appendix B (“Definitions”). Any capitalized term that is not defined herein or in
Appendix B has the meaning provided in 45 C.F.R. § 155.20.

The NEE SSP template is located on CMS zONE at the following link: https://zone.cms.gov/document/privacyand-security-audit.
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II.

Interconnection Security Agreement (ISA) Between Centers for Medicare & Medicaid
Services (CMS) and Enhanced Direct Enrollment (EDE) Entity (“ISA”).

If EDE Entity is a Primary EDE Entity, it must enter into an ISA with CMS. EDE Entity must
comply with all terms of the ISA, 2 including the privacy and security compliance requirements
set forth in the ISA. The ISA shall be in effect for the full duration of this Agreement. If an
Upstream EDE Entity is using a Primary EDE Entity’s EDE Environment, the Primary EDE
Entity must supply an NEE SSP to each Upstream EDE Entity using the Primary EDE Entity’s
EDE Environment that identifies all Common Controls and Hybrid Controls implemented in the
EDE Environment. All Common Controls and Hybrid Controls must be documented between
each applicable Upstream EDE Entity and its Primary EDE Entity as required by the NEE SSP
section “Common and Hybrid Controls.” Furthermore, Appendix B of the ISA requires a
Primary EDE Entity to attest that it has documented and shared the NEE SSP inheritable
Common Controls and Hybrid Controls with applicable Upstream EDE Entities.
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III.

Acceptance of Standard Rules of Conduct.

EDE Entity and CMS are entering into this Agreement to satisfy the requirements under
45 C.F.R. §§ 155.260(b)(2) and 155.221(b)(4)(v). EDE Entity hereby acknowledges and agrees
to accept and abide by the standard rules of conduct set forth below and in the Appendices,
which are incorporated by reference in this Agreement, while and as engaging in any activity as
EDE Entity for purposes of the ACA. EDE Entity shall strictly adhere to the privacy and security
standards—and ensure that its employees, officers, directors, contractors, subcontractors, agents,
Auditors, and representatives strictly adhere to the same—to gain and maintain access to the Hub
Web Services and to create, collect, disclose, access, maintain, store, and use PII for the efficient
operation of the FFEs and SBE-FPs. To the extent the privacy and security standards set forth in
this Agreement are different than privacy and security standards applied to EDE Entity through
any existing agreements with CMS, the more stringent privacy and security standards shall
control.
a. Authorized Functions. EDE Entity may create, collect, disclose, access, maintain,
store, and use PII for the following, if applicable:
1. Assisting with completing applications for QHP eligibility;
2. Supporting QHP selection and enrollment by assisting with plan selection
and plan comparisons;
3. Assisting with completing applications for the receipt of APTC or CSRs
and with selecting an APTC amount;
4. Facilitating the collection of standardized attestations acknowledging the
receipt of the APTC or CSR determination, if applicable;
5. Assisting with the application for and determination of certificates of
exemption;
Unless specifically indicated otherwise, references to the ISA refer to the current, legally enforceable version of the
agreement. The ISA is available on CMS zONE at the following link: https://zone.cms.gov/document/privacy-andsecurity-audit.
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6. Assisting with filing appeals of eligibility determinations in connection
with the FFEs and SBE-FPs;
7. Transmitting information about the Consumer’s, Applicant’s, Qualified
Individual’s, or Enrollee’s decisions regarding QHP enrollment and/or
CSR and APTC information to the FFEs and SBE-FPs;
8. Facilitating payment of the initial premium amount to the appropriate
QHP Issuer;
9. Facilitating an Enrollee’s ability to disenroll from a QHP;
10. Educating Consumers, Applicants, Qualified Individuals or Enrollees—or
these individuals’ legal representatives or Authorized Representatives—
on Insurance Affordability Programs and, if applicable, informing such
individuals of eligibility for Medicaid or the Children’s Health Insurance
Program (CHIP);
11. Assisting an Enrollee in reporting changes in eligibility status to the FFEs
and SBE-FPs throughout the coverage year, including changes that may
affect eligibility (e.g., adding a dependent);
12. Correcting errors in the application for QHP enrollment;
13. Informing or reminding Enrollees when QHP coverage should be
renewed, when Enrollees may no longer be eligible to maintain their
current QHP coverage because of age, or to inform Enrollees of QHP
coverage options at renewal;
14. Providing appropriate information, materials, and programs to Consumers,
Applicants, Qualified Individuals, and Enrollees—or these individuals’
legal representatives or Authorized Representatives—to inform and
educate them about the use and management of their health information,
as well as medical services and benefit options offered through the
selected QHP or among the available QHP options;
15. Contacting Consumers, Applicants, Qualified Individuals, and Enrollees—
or these individuals’ legal representatives or Authorized
Representatives—to assess their satisfaction or resolve complaints with
services provided by EDE Entity in connection with the FFEs, SBE-FPs,
EDE Entity, or QHPs;
16. Providing assistance in communicating with QHP Issuers;
17. Fulfilling the legal responsibilities related to the efficient functions of
QHP Issuers in the FFEs and SBE-FPs, as permitted or required by a Webbroker EDE Entity’s contractual relationships with QHP Issuers; and
18. Performing other functions substantially similar to those enumerated
above and such other functions that CMS may approve in writing from
time to time.

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b. Collection of PII. Subject to the terms and conditions of this Agreement and
applicable laws, in performing the tasks contemplated under this Agreement, EDE
Entity may create, collect, disclose, access, maintain, store, and use the following
PII from Consumers, Applicants, Qualified Individuals, or Enrollees—or these
individuals’ legal representatives or Authorized Representatives— including, but
not limited to:
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
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APTC percentage and amount applied
Auto disenrollment information
Applicant name
Applicant address
Applicant birthdate
Applicant telephone number
Applicant email
Applicant Social Security Number
Applicant spoken and written language preference
Applicant Medicaid Eligibility indicator, start and end dates
Applicant CHIP eligibility indicator, start and end dates
Applicant QHP eligibility indicator, start and end dates
Applicant APTC percentage and amount applied eligibility indicator, start
and end dates
Applicant household income
Applicant maximum APTC amount
Applicant CSR eligibility indicator, start and end dates
Applicant CSR level
Applicant QHP eligibility status change
Applicant APTC eligibility status change
Applicant CSR eligibility status change
Applicant Initial or Annual Open Enrollment Indicator, start and end dates
Applicant Special Enrollment Period (“SEP”) eligibility indicator and
reason code
Contact name
Contact address
Contact birthdate
Contact telephone number
Contact email
Contact spoken and written language preference
Enrollment group history (past six months)
Enrollment type period
FFE Applicant ID
FFE Member ID
Issuer Member ID
Net premium amount
Premium amount, start and end dates

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•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
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Credit or Debit Card Number, name on card
Checking account and routing number
SEP reason
Subscriber indicator and relationship to subscriber
Tobacco use indicator and last date of tobacco use
Custodial parent
Health coverage
American Indian/Alaska Native status and name of tribe
Marital status
Race/ethnicity
Requesting financial assistance
Responsible person
Dependent name
Applicant/dependent sex
Student status
Subscriber indicator and relationship to subscriber
Total individual responsibility amount
Immigration status
Immigration document number
Naturalization document number

c. Security and Privacy Controls. EDE Entity agrees to monitor, periodically assess, and
update its security controls and related system risks to ensure the continued
effectiveness of those controls in accordance with this Agreement, including the NEE
SSP. Furthermore, EDE Entity agrees to timely inform the Exchange of any material
change in its administrative, technical, or operational environments, or any material
change that would require an alteration of the privacy and security standards within
this Agreement through the EDE Entity-initiated Change Request process (Section
IX.c of this Agreement).
d. Use of PII. PII collected from Consumers, Applicants, Qualified Individuals, and
Enrollees—or these individuals’ legal representatives or Authorized
Representatives—in the context of completing an application for QHP, APTC, or
CSR eligibility, if applicable, or enrolling in a QHP, or any data transmitted from or
through the Hub, if applicable, may be used only for Authorized Functions specified
in Section III.a of this Agreement. Such PII may not be used for purposes other than
authorized by this Agreement or as consented to by a Consumer, Applicant, Qualified
Individual, and Enrollee—or these individuals’ legal representatives or Authorized
Representatives.
e. Collection and Use of PII Provided Under Other Authorities. This Agreement does
not preclude EDE Entity from collecting PII from Consumers, Applicants, Qualified
Individuals, and Enrollees—or these individuals’ legal representatives or Authorized
Representatives—for a non-FFE/non-SBE-FP/non-Hub purpose, and using, reusing,
and disclosing PII obtained as permitted by applicable law and/or other applicable

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authorities. Such PII must be stored separately from any PII collected in accordance
with Section III.b of this Agreement.
f. Ability of Individuals to Limit Collection and Use of PII. EDE Entity agrees to
provide the Consumer, Applicant, Qualified Individual, or Enrollee—or these
individuals’ legal representatives or Authorized Representatives—the opportunity to
opt in to have EDE Entity collect, create, disclose, access, maintain, store, and use
their PII. EDE Entity agrees to provide a mechanism through which the Consumer,
Applicant, Qualified Individual, or Enrollee—or these individuals’ legal
representatives or Authorized Representatives—can limit the collection, creation,
disclosure, access, maintenance, storage and use of his or her PII for the sole purpose
of obtaining EDE Entity’s assistance in performing Authorized Functions specified in
Section III.a of this Agreement.
g. Downstream and Delegated Entities. EDE Entity will satisfy the requirement in
45 C.F.R. § 155.260(b)(2)(v) to require Downstream and Delegated Entities to adhere
to the same privacy and security standards that apply to Non-Exchange Entities by
entering into written agreements with any Downstream and Delegated Entities that
will have access to PII collected in accordance with this Agreement. EDE Entity must
require in writing all Downstream and Delegated Entities adhere to the terms of this
Agreement.
Upon request, EDE Entity must provide CMS with information about its downstream
Agents/Brokers, EDE Entity’s oversight of its downstream Agents/Brokers, and the
EDE Environment(s) it provides to each of its downstream Agents/Brokers.
h. Commitment to Protect PII. EDE Entity shall not release, publish, or disclose
Consumer, Applicant, Qualified Individual, or Enrollee PII to unauthorized
personnel, and shall protect such information in accordance with provisions of any
laws and regulations governing the adequate safeguarding of Consumer, Applicant,
Qualified Individual, or Enrollee PII, the misuse of which carries with it the potential
to cause financial, reputational, and other types of harm.
1. Technical leads must be designated to facilitate direct contacts between the
Parties to support the management and operation of the interconnection.
2. The overall sensitivity level of data or information that will be made available or
exchanged across the interconnection will be designated as MODERATE as
determined by Federal Information Processing Standards (FIPS) Publication 199.
3. EDE Entity agrees to comply with all federal laws and regulations regarding the
handling of PII—regardless of where the organization is located or where the data
are stored and accessed.
4. EDE Entity’s Rules of Behavior must be at least as stringent as the HHS Rules of
Behavior. 3
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The HHS Rules of Behavior are available at the following link: https://www.hhs.gov/ocio/policy/hhs-rob.html.

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5. EDE Entity understands and agrees that all financial and legal liabilities arising
from inappropriate disclosure or Breach of Consumer, Applicant, Qualified
Individual, or Enrollee PII while such information is in the possession of EDE
Entity shall be borne exclusively by EDE Entity.
6. EDE Entity shall train and monitor staff on the requirements related to the
authorized use and sharing of PII with third parties and the consequences of
unauthorized use or sharing of PII, and periodically audit their actual use and
disclosure of PII.
IV.

Effective Date and Term; Renewal.
a. Effective Date and Term. This Agreement becomes effective on the date the last of
the two Parties executes this Agreement and ends the Day before the first Day of the
open enrollment period (“OEP”) under 45 C.F.R. § 155.410(e)(3) for the benefit year
beginning January 1, 2025.
b. Renewal. This Agreement may be renewed upon the mutual agreement of the Parties
for subsequent and consecutive one (1) year periods upon thirty (30) Days’ advance
written notice to EDE Entity.

V.

Termination.
a. Termination without Cause. Either Party may terminate this Agreement without cause
and for its convenience upon thirty (30) Days’ prior written notice to the other Party.
EDE Entity must reference and complete the NEE Decommissioning Plan and NEE
Decommissioning Close Out Letter in situations where EDE Entity will retire or
decommission its EDE Environment. 4
3F

b. Termination of Agreement with Notice by CMS. The termination of this Agreement
and the reconsideration of any such termination shall be governed by the termination
and reconsideration standards adopted by the FFEs or SBE-FPs under 45 C.F.R. §
155.220. Notwithstanding the foregoing, EDE Entity shall be considered in “Habitual
Default” of this Agreement in the event that it has been served with a non-compliance
notice under 45 C.F.R. § 155.220(g) or an immediate suspension notice under Section
V.c of this Agreement more than three (3) times in any calendar year, whereupon
CMS may, in its sole discretion, immediately terminate this Agreement upon notice to
EDE Entity without any further opportunity to resolve the Breach and/or noncompliance.
c. Termination of Interconnection for Non-compliance. Instances of non-compliance
with the privacy and security standards and operational requirements under this
Agreement by EDE Entity, which may or may not rise to the level of a material
Breach of this Agreement, may lead to termination of the interconnection between the
Parties. CMS may block EDE Entity’s access to CMS systems if EDE Entity does not
The Non-Exchange Entity (NEE) Decommissioning Plan and NEE Decommissioning Close Out Letter are
available on CMS zONE at the following link: https://zone.cms.gov/document/privacy-and-security-audit.
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implement reasonable precautions to prevent the risk of Security Incidents spreading
to CMS’ network or based on the existence of unmitigated privacy or security risks,
or the misuse of the PII of Consumers, Applicants, Qualified Individuals, and
Enrollees—or these individuals’ legal representatives or Authorized Representatives.
In accordance with Section X.m of this Agreement, CMS is authorized to audit the
security of EDE Entity’s network and systems periodically by requesting that EDE
Entity provide documentation of compliance with the privacy and security
requirements in this Agreement and in the ISA. EDE Entity shall provide CMS access
to its information technology resources impacted by this Agreement for the purposes
of audits. CMS may suspend or terminate the interconnection if EDE Entity does not
comply with such a compliance review request within seven (7) business days, or
within such longer time period as determined by CMS. Further, notwithstanding
Section V.b of this Agreement, CMS may immediately suspend EDE Entity’s ability
to transact information with the FFEs or SBE-FPs via use of its EDE Environment if
CMS discovers circumstances that pose unacceptable or unmitigated risk to FFE
operations or CMS information technology systems. If EDE Entity’s ability to
transact information with the FFEs or SBE-FPs is suspended, CMS will provide EDE
Entity with written notice within two (2) business days.
d. Effect of Termination. Termination of this Agreement will result in termination of the
functionality and electronic interconnection(s) covered by this Agreement, but will
not affect obligations under EDE Entity’s other respective agreement(s) with CMS,
including the QHP Issuer Agreement, the Web-broker Agreement, or the Agent
Broker General Agreement for Individual Market Federally-Facilitated Exchanges
and State-Based Exchanges on the Federal Platform (Agent/Broker Agreement).
However, the termination of EDE Entity’s ISA, QHP Issuer Agreement, or Webbroker Agreement will result in termination of this Agreement and termination of
EDE Entity’s connection to CMS systems, including its connection to the Hub and
ability to access the EDE suite of APIs as allowed by this Agreement. CMS may
terminate this Agreement and EDE Entity’s connection to CMS systems, consistent
with this clause, if a Designated Representative, who is associated with the EDE
Entity, has their Agent/Broker Agreement terminated by CMS.
e. Notice to Consumers, Applicants, Qualified Individuals, or Enrollees—or these
individuals’ legal representatives or Authorized Representatives—of Termination of
the Interconnection/Agreement, Suspension of Interconnection, and Nonrenewal of
Agreement. EDE Entity must provide Consumers, Applicants, Qualified Individuals,
or Enrollees—or these individuals’ legal representatives or Authorized
Representatives—with written notice of termination of this Agreement without cause,
as permitted under Section V.a of this Agreement, no less than ten (10) Days prior to
the date of termination. Within ten (10) Days after termination or expiration of this
Agreement or termination or suspension of the interconnection, EDE Entity must
provide Consumers, Applicants, Qualified Individuals, or Enrollees—or these
individuals’ legal representatives or Authorized Representatives—with written notice
of termination of this Agreement with cause under Section V.b of this Agreement;
termination or suspension of the interconnection for non-compliance under Section
V.c of this Agreement; termination resulting from termination of EDE Entity’s ISA,

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QHP Issuer Agreement, or Web-broker Agreement under Section V.d of this
Agreement; or non-renewal of this Agreement.
The written notice required by this Section shall notify each Consumer, Applicant,
Qualified Individual, or Enrollee—or these individuals’ legal representatives or
Authorized Representatives—of the date the termination or suspension of the
interconnection will or did occur and direct the Consumer, Applicant, Qualified
Individual, or Enrollee—or these individuals’ legal representatives or Authorized
Representatives—to access his or her application through the FFE (HealthCare.gov or
the Marketplace Call Center at 1-800-318-2596 [TTY: 1-855-889-4325]) after that
date. The written notice shall also provide sufficient details to the Consumer,
Applicant, Qualified Individual, or Enrollee—or these individuals’ legal
representatives or Authorized Representatives—, including, but not limited to the
Consumer’s, Applicant’s, Qualified Individual’s, or Enrollee’s Application ID,
pending actions, and enrollment status, to allow the Consumer, Applicant, Qualified
Individual, or Enrollee—or these individuals’ legal representatives or Authorized
Representatives—to update his or her application and provide the next steps
necessary to update the Consumer’s, Applicant’s, Qualified Individual’s, or
Enrollee’s application through the FFE. If EDE Entity’s interconnection has been
suspended, the written notice must also state that EDE Entity will provide updates to
the Consumer, Applicant, Qualified Individual, or Enrollee—or these individuals’
legal representatives or Authorized Representatives—regarding the Consumer’s,
Applicant’s, Qualified Individual’s, or Enrollee’s—or these individuals’ legal
representatives or Authorized Representatives—ability to access his or her
application through EDE Entity’s website in the future.
In addition to providing written notice to Consumers, Applicants, Qualified
Individuals, or Enrollees—or these individuals’ legal representatives or Authorized
Representatives—EDE Entity must also prominently display notice of the termination
or suspension of the interconnection on EDE Entity’s website, including language
directing Consumers, Applicants, Qualified Individuals, or Enrollees—or these
individuals’ legal representatives or Authorized Representatives—to access their
applications through the FFE (HealthCare.gov or the Marketplace Call Center at
1-800-318-2596 [TTY: 1-855-889-4325]).
This clause will survive the expiration or termination of this Agreement.
f. Destruction of PII. EDE Entity covenants and agrees to destroy all PII in its
possession at the end of the record retention period required under the NEE SSP. EDE
Entity’s duty to protect and maintain the privacy and security of PII, as provided for
in the NEE SSP, shall continue in full force and effect until such PII is destroyed and
shall survive the termination or expiration of this Agreement.
This clause will survive expiration or termination of this Agreement.

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VI.

Use of EDE Entity’s EDE Environment by Agents, Brokers, or DE Entity Application
Assisters.
a. General. EDE Entity may allow third-party Agents, Brokers, or DE Entity
Application Assisters that are not or will not be a party to their own EDE Agreement
with CMS to enroll Qualified Individuals in QHPs and to assist individuals in
applying for APTC and CSRs through EDE Entity’s EDE Environment. EDE Entity,
or an Upstream EDE Entity 5 for which EDE Entity provides an EDE Environment,
must have a contractual and legally binding relationship with its third-party Agents,
Brokers, or DE Entity Application Assisters reflected in a signed, written agreement
between the third-party Agents, Brokers, or DE Entity Application Assisters and EDE
Entity.
4F

Except as provided in this Section, or as documented for CMS review and approval
consistent with Section IX.c of this Agreement as a data connection in the ISA, EDE
Entity may not establish a data connection between a third-party Agent’s or Broker’s
website and the EDE Entity’s EDE Environment that transmits any data.
The use of embedding tools and programming techniques, such as iframe technical
implementations, which may enable the distortion, manipulation, or modification of
the audited and approved EDE Environment and the overall EDE End-User
Experience developed by a Primary EDE Entity, are prohibited unless explicitly
approved through the EDE Entity-initiated Change Request process consistent with
Section IX.c of this Agreement.
The EDE Entity environment must limit the number of concurrent sessions to one (1)
session per a single set of credentials/FFE user ID. However, multiple sessions
associated with a single set of credentials/FFE user ID that is traceable to a single
device/browser is permitted.
b. Downstream White-Label Third-Party User Arrangement Requirements. Downstream
third-party Agent and Broker arrangements may be Downstream White-Label ThirdParty User Arrangements for which a Primary EDE Entity enables the third-party
Agent or Broker to only make minor branding changes to the Primary EDE Entity’s
EDE Environment (i.e., adding an Agent’s or Broker’s logo or name to an EDE
Environment). The use of embedding tools and programming techniques, such as
iframe technical implementations, which may enable the distortion, manipulation, or
modification of the audited and approved EDE Environment and the overall EDE
End-User Experience developed by a Primary EDE Entity, are prohibited unless
explicitly approved through the EDE Entity-initiated Change Request process
consistent with Section IX.c of this Agreement.
c. Downstream White-Label Third-Party User Arrangement Data Exchange Limited
Flexibility. With prior written approval from CMS, Downstream White-Label ThirdParty User Arrangements may allow limited data collection from the Consumer,
Applicant, Qualified Individual, or Enrollee—or these individuals’ legal
Permissible Upstream EDE Entity arrangements are defined in Sections VIII.f, VIII.g, and VIII.h of this
Agreement.

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representatives or Authorized Representatives—on the Downstream third-party
Agent’s or Broker’s website that can be used in the EDE End-User Experience via a
one-way limited data connection to the Primary EDE Entity’s EDE Environment. The
following types of limited data collection by the third-party Agent’s or Broker’s
website are permissible under this clause: 1) data to determine if a Consumer,
Applicant, Qualified Individual, or Enrollee is (or should be) shopping for QHPs,
such as basic information to assess potential eligibility for financial assistance, as
well as to estimate premiums (e.g., household income, ages of household members,
number of household members, and tobacco use status); and 2) data related to the
Consumer’s, Applicant’s, Qualified Individual’s, or Enrollee’s service area (e.g., zip
code, county, and State).
As part of the EDE-facilitated application and QHP enrollment processes, EDE Entity
must not enable or allow the selection of QHPs by a Consumer or Agent/Broker on a
third-party website that exists outside of the EDE Entity’s approved DE Environment.
This includes pre-populating or pre-selecting a QHP for a Consumer that was selected
on a downstream Agent’s/Broker’s website or a lead generator’s website. This
prohibition does not extend to websites that are provided, owned, and maintained by
entities subject to CMS regulations for QHP display (i.e., Web-brokers and QHP
Issuers).
In any limited data collection arrangement, the data must be transmitted securely and
in one direction only (i.e., from the downstream Agent or Broker to the Primary EDE
Entity’s EDE Environment). EDE Entity must not provide access to Consumer,
Applicant, Qualified Individual, or Enrollee data to the third-party Agent or Broker
outside of the EDE End-User Experience unless otherwise specified in Sections III.d,
III.e, and III.f of this Agreement. Additionally, the Downstream White-Label ThirdParty User Arrangement must not involve additional data exchanges beyond what is
outlined above as permissible, which takes place in conjunction with the initial
redirect prior to the beginning of the EDE End-User Experience on the Primary EDE
Entity’s EDE Environment.
d. Oversight Responsibilities. EDE Entity may only allow third-party Agents, Brokers,
and DE Entity Application Assisters who are validly registered with the FFE for the
applicable plan year to use its approved EDE Environment. EDE Entity must not
provide access to its approved EDE Environment, the EDE End-User Experience or
any data obtained via the EDE End-User Experience to an Agent or Broker until the
Agent or Broker has completed the process for Agent or Broker Identity Proofing
consistent with the requirements in Section IX.r of this Agreement.
VII.

QHP Issuer Use of an EDE Environment.

QHP Issuer EDE Entities, operating as Primary EDE Entities or Upstream EDE Entities, must
bind all affiliated Issuer organizations (i.e., HIOS IDs) that use its EDE Environment or EDE
End-User Experience—either for Consumer, Applicant, Qualified Individual, or Enrollee—or
these individuals’ legal representatives or Authorized Representatives—use or Agent or Broker
use—to the terms and provisions of this Agreement. QHP Issuer EDE Entities must identify all
applicable affiliated Issuer organizations that will use its EDE Environment during the
12

onboarding process in the “Operational and Oversight Information” form provided by CMS 6.
The signatory of this Agreement on behalf of the QHP Issuer EDE Entity must have sufficient
authority to execute an agreement with CMS on behalf of the QHP Issuer EDE Entity and all
affiliated QHP Issuer organizations that use the QHP Issuer EDE Entity’s EDE Environment or
EDE End-User Experience. QHP Issuer EDE Entities must identify all applicable affiliated QHP
Issuer organizations in the “Operational and Oversight Information” form provided by CMS.
5F

VIII.

Audit Requirements.
a. Operational Readiness Review (“ORR”). In order to receive approval to participate in
EDE and utilize an integrated EDE Environment, EDE Entity must contract with one
or more independent Auditor(s) consistent with this Agreement’s provisions and
applicable regulatory requirements to conduct an ORR, composed of a business
requirements audit and a privacy and security audit. 7 EDE Entity must follow the
detailed guidance CMS provided in Third-party Auditor Operational Readiness
Reviews for the Enhanced Direct Enrollment Pathway and Related Oversight
Requirements. 8
6F

7F

The Auditor must document and attest in the ORR report that EDE Entity’s EDE
Environment, including its website and operations, complies with the terms of this
Agreement, the ISA, EDE Entity’s respective agreement(s) with CMS (including the
QHP Issuer Agreement or the Web-broker Agreement), the Framework for the
Independent Assessment of Security and Privacy Controls for Enhanced Direct
Enrollment Entities, 9 and applicable program requirements. If an EDE Entity will
offer its EDE Environment in a State in which a non-English language is spoken by a
Limited English Proficient (LEP) population that reaches ten (10) percent or more of
the State’s population, as determined in guidance published by the Secretary of
HHS, 10 the Auditor conducting EDE Entity’s business requirements audit must also
audit the non-English language version of the application user interface (UI) and any
critical communications EDE Entity sends Consumers, Applicants, Qualified
Individuals, or Enrollee —or these individuals’ legal representatives or Authorized
Representatives—in relation to their use of its EDE Environment for compliance with
8F

9F

The Operational and Oversight Information form is available in the PY 2023 DE Documentation Package zip file
on CMS zONE at the following link: https://zone.cms.gov/document/business-audit.
7
The Auditor must use NIST SP 800-53A, which describes the appropriate assessment procedure (examine,
interview, and test) for each control to evaluate that the control is effectively implemented and operating as
intended.
8
This document is available at the following link: https://www.cms.gov/files/document/guidelines-enhanced-directenrollment-audits-year-6-final.pdf.
9
This document is available at the following link within the Privacy and Security Templates Resources:
https://zone.cms.gov/document/privacy-and-security-audit.
10
Guidance and Population Data for Exchanges, Qualified Health Plan Issuers, and Web-Brokers to Ensure
Meaningful Access by Limited-English Proficient Speakers Under 45 CFR §155.205(c) and §156.250 (March 30,
2016) https://www.cms.gov/CCIIO/Resources/Regulations-and-Guidance/Downloads/Language-accessguidance.pdf and “Appendix A- Top 15 Non-English Languages by State” https://www.cms.gov/CCIIO/Resources/
Regulations-and-Guidance/Downloads/Appendix-A-Top-15-non-english-by-state-MM-508_update12-20-16.pdf.
HHS may release revised guidance. DE Entity should refer to the most current HHS guidance.
6

13

applicable CMS requirements. EDE Entity must submit the resulting business
requirements and privacy and security audit packages to CMS.
The ORR must detail EDE Entity’s compliance with the requirements set forth in
Appendix C, including any requirements set forth in CMS guidance referenced in
Appendix C. 11 The business requirements and privacy and security audit packages
EDE Entity submits to CMS must demonstrate that EDE Entity’s Auditor(s)
conducted its review in accordance with the review standards set forth in Appendix C
and in Third-party Auditor Operational Readiness Reviews for the Enhanced Direct
Enrollment Pathway and Related Oversight Requirements.
10F

CMS will approve EDE Entity’s EDE Environment only once it has reviewed and
approved the business requirements audit and privacy and security audit findings
reports. Final approval of EDE Entity’s EDE Environment will be evidenced by CMS
countersigning the ISA with EDE Entity. Upon receipt of the counter-signed ISA,
EDE Entity will be approved to use its approved EDE Environment consistent with
applicable regulations, this Agreement, and the ISA.
b. Identification of Auditor(s) and Subcontractors of Auditor(s). All Auditor(s),
including any Auditor(s) that has subcontracted with EDE Entity’s Auditor(s), will be
considered Downstream or Delegated Entities of EDE Entity pursuant to EDE
Entity’s respective agreement(s) with CMS (including the QHP Issuer Agreement or
the Web-broker Agreement) and applicable program requirements. EDE Entity must
identify each Auditor it selects, and any subcontractor(s) of the Auditor(s), in
Appendix E of this Agreement. EDE Entity must also submit a copy of the signed
agreement or contract between the Auditor(s) and EDE Entity to CMS.
c. Conflict of Interest. For any arrangement between EDE Entity and an Auditor for
audit purposes covered by this Agreement, EDE Entity must select an Auditor that is
free from any real or perceived conflict(s) of interest, including being free from
personal, external, and organizational impairments to independence, or the
appearance of such impairments to independence. EDE Entity must disclose to HHS
any financial relationships between the Auditor, and individuals who own or are
employed by the Auditor, and individuals who own or are employed by an EDE
Entity for which the Auditor is conducting an ORR pursuant to 45 C.F.R. §§
155.221(b)(4) and (f). EDE Entity must document and disclose any conflict(s) of
interest in the form in Appendix F, if applicable.
d. Auditor Independence and Objectivity. EDE Entity’s Auditor(s) must remain
independent and objective throughout the audit process for both audits. An Auditor is
independent if there is no perceived or actual conflict of interest involving the
developmental, operational, and/or management chain associated with the EDE
Environment and the determination of security and privacy control effectiveness or
business requirement compliance. EDE Entity must not take any actions that impair

The table in Appendix C is an updated version of Exhibit 2 in the “Third-party Auditor Operational Readiness
Reviews for the Enhanced Direct Enrollment Pathway and Related Oversight Requirements.”
11

14

the independence and objectivity of EDE Entity’s Auditor. EDE Entity’s Auditor
must attest to their independence and objectivity in completing the EDE audit(s).
e. Required Documentation. EDE Entity must maintain and/or submit the required
documentation detailed in Appendix D, including templates provided by CMS, to
CMS in the manner specified in Appendix D. 12 Documentation that EDE Entity must
submit to CMS (as set forth in Appendix D) will constitute EDE Entity’s EDE
Application.
11F

f. Use of an EDE Environment by a QHP Issuer with Minor Branding Deviations
(White-Label Issuer Upstream EDE Entity).
A QHP Issuer EDE Entity may use an approved EDE Environment provided by a
Primary EDE Entity. If a QHP Issuer EDE Entity implements and uses an EDE
Environment that is identical to its Primary EDE Entity’s EDE Environment, except
for minor deviations for branding or QHP display changes relevant to the Issuer’s
QHPs, the QHP Issuer EDE Entity is not required to submit a business requirements
audit package and privacy and security audit package. CMS refers to a QHP Issuer
EDE Entity operating consistent with this Section as a White-Label Issuer Upstream
EDE Entity. In all arrangements permitted under this Section, all aspects of the preapplication, application, enrollment, and post-enrollment experience and any data
collected necessary for those steps or for the purposes of any Authorized Functions
specified in Section III.a of this Agreement must be conducted within the confines of
the Primary EDE Entity’s approved EDE Environment.
In all arrangements permitted under this Section, the White-Label Issuer Upstream
EDE Entity is responsible for compliance with all of the requirements contained in all
applicable regulations and guidance, as well as in this Agreement. This includes
oversight of the Primary EDE Entity and ensuring its Primary EDE Entity’s EDE
Environment complies with all applicable regulations, including QHP display
requirements for Issuers as defined in 45 C.F.R. §§ 155.221, 156.265 and 156.1230,
operational requirements, this Agreement, and the ISA. Any Primary EDE Entity
supplying an EDE Environment to a White-Label Issuer Upstream EDE Entity will be
considered a Downstream or Delegated Entity of the White-Label Issuer Upstream
EDE Entity. A White-Label Issuer Upstream EDE Entity must identify its Primary
EDE Entity in the “Operational and Oversight Information” form provided by CMS .
A White-Label Issuer Upstream EDE Entity must have a contractual and legally
binding relationship with its Primary EDE Entity reflected in a signed, written
agreement between the White-Label Issuer Upstream EDE Entity and the Primary
EDE Entity.
g. Use of an EDE Environment by a QHP Issuer with Additional Functionality or
Systems (Hybrid Issuer Upstream EDE Entity).
If a QHP Issuer EDE Entity will implement its own EDE Environment composed, in
part, of an approved EDE Environment provided by a Primary EDE Entity and, in
The table in Appendix D is a combined version of Exhibits 4 and 7 in the “Third-party Auditor Operational
Readiness Reviews for the Enhanced Direct Enrollment Pathway and Related Oversight Requirements.”
12

15

part, of additional functionality or systems implemented by or on behalf of the QHP
Issuer EDE Entity, the QHP Issuer EDE Entity may be required to retain an Auditor
to conduct part(s) of the ORR relevant to functionalities and systems implemented by
the QHP Issuer EDE Entity outside of the Primary EDE Entity’s EDE Environment,
or in addition to the Primary EDE Entity’s approved EDE Environment, and to
analyze the effect, if any, of those functionalities and systems on the operations and
compliance of the Primary EDE Entity’s approved EDE Environment. CMS refers to
a QHP Issuer EDE Entity operating consistent with this Section as a Hybrid Issuer
Upstream EDE Entity. In this scenario, the Hybrid Issuer Upstream EDE Entity may
be required to submit to CMS an ORR audit package that contains the results of the
supplemental business requirements audit and/or privacy and security audit, as
appropriate, in which the Auditor reviewed the additional functionality or systems
implemented by or on behalf of the Hybrid Issuer Upstream EDE Entity. The Hybrid
Issuer Upstream EDE Entity may be required to submit to CMS an ORR consisting of
the results of its Auditor’s review of its implementation of non-inheritable, Hybrid
and inheritable but not inherited EDE privacy and security controls. The ORR audit
package that contains the results of the business requirements audit and/or privacy
and security audit covering additional functionality or systems implemented by or on
behalf of the Hybrid Issuer Upstream EDE Entity must demonstrate the Hybrid Issuer
Upstream EDE Entity’s compliance with applicable regulations, operational
requirements, this Agreement, and the ISA. The Hybrid Issuer Upstream EDE Entity
does not need to submit the Primary EDE Entity’s ORR.
CMS considers any changes to the Primary EDE Entity’s approved EDE
Environment or the overall EDE End-User Experience—beyond minor deviations for
branding or QHP display changes relevant to the Issuer’s QHPs—to be the addition
of functionality or systems to an approved EDE Environment subject to the
requirements of this Section.
CMS has identified the following non-exclusive list as additional functionality that
requires a supplemental audit submission:
1. Hybrid Issuer Upstream EDE Entities implementing a single sign-on (SSO)
solution must retain an Auditor to conduct a supplemental security and privacy
audit and submit the results to CMS consistent with the EDE Guidelines. 13
12F

In all arrangements permitted under this paragraph, the Hybrid Issuer Upstream EDE
Entity is responsible for compliance with all of the requirements contained in all
applicable regulations and guidance, including QHP display requirements for Issuers
as defined in 45 C.F.R. §§ 155.221, 156.265, and 156.1230, as well as in this
Agreement. This includes oversight of the Primary EDE Entity and ensuring its
Primary EDE Entity’s EDE Environment complies with all applicable regulations,
including QHP display requirements for Issuers as defined in 45 C.F.R. §§ 155.221,
156.265 and 156.1230, operational requirements, this Agreement, and the ISA. Any
A Hybrid Issuer Upstream EDE Entity implementing a SSO solution may leverage prior audit results that assessed
some or all control requirements listed in Exhibit 14 of the EDE Guidelines, available at the following link:
https://www.cms.gov/files/document/guidelines-enhanced-direct-enrollment-audits-year-6-final.pdf if the prior audit
was conducted within one year of the date of submission of the audit documentation to CMS.
13

16

Primary EDE Entity supplying an EDE Environment to the Hybrid Issuer Upstream
EDE Entity will be considered a Downstream or Delegated Entity of the Hybrid
Issuer Upstream EDE Entity. A Hybrid Issuer Upstream EDE Entity must identify its
Primary EDE Entity in the “Operational and Oversight Information” form provided
by CMS . The Hybrid Issuer Upstream EDE Entity must have a contractual and
legally binding relationship with its Primary EDE Entity reflected in a signed, written
agreement between the Hybrid Issuer Upstream EDE Entity and the Primary EDE
Entity. The Primary EDE Entity must identify inheritable Common Controls and
Hybrid Controls that the Hybrid Issuer Upstream EDE Entity should leverage. The
inherited Common Controls and Hybrid Controls must be documented in the NEE
SSP Template and must also be documented as part of the written contract between
the Primary EDE Entity and the Hybrid Issuer Upstream EDE Entity.
A Hybrid Issuer Upstream EDE Entity operating under this provision cannot provide
access to its EDE Environment to another Issuer or a Hybrid Non-Issuer Upstream
EDE Entity.
h. Use of an EDE Environment by a Non-Issuer Entity with Additional Functionality or
Systems (Hybrid Non-Issuer Upstream EDE Entity).
If a Hybrid Non-Issuer Upstream EDE Entity will implement its own EDE
Environment composed, in part, of an approved EDE Environment provided by a
Primary EDE Entity and, in part, of additional functionality or systems implemented
by or on behalf of the Hybrid Non-Issuer Upstream EDE Entity, the Hybrid NonIssuer EDE Entity must retain an Auditor to conduct part(s) of the ORR relevant to
functionalities and systems implemented by the Hybrid Non-Issuer EDE Entity
outside of the Primary EDE Entity’s EDE Environment, or in addition to the Primary
EDE Entity’s approved EDE Environment, and to analyze the effect, if any, of those
functionalities and systems on the operations and compliance of the Primary EDE
Entity’s approved EDE Environment. 14 In this scenario, the Hybrid Non-Issuer EDE
Entity must submit an ORR consisting of the results of its Auditor’s review of its
implementation of non-inheritable, Hybrid and inheritable but not inherited EDE
privacy and security controls. The Hybrid Non-Issuer EDE Entity may also be
required to submit to CMS a supplemental ORR audit package that contains the
results of any supplemental business requirements and/or privacy and security audits,
as appropriate, in which the Auditor reviewed the additional functionality or systems
implemented by or on behalf of the Hybrid Non-Issuer EDE Entity. 15 The ORR, and
13F

14F

With respect to Agents and Brokers regulated by this section as Hybrid Non-Issuer Upstream EDE Entities, these
arrangements are distinct and independent from those arrangements regulated under Section VI of this Agreement.
An Agent or Broker in a limited data-sharing arrangement consistent with Section VI.c of this Agreement would not
necessarily also be subject to the requirements for Hybrid Non-Issuer Upstream EDE Entities under Section VIII.h
of this Agreement. The determination of what requirements apply to a particular arrangement will be a fact heavy
analysis that takes into account the specific details of the arrangement.
15
A Hybrid Non-Issuer Upstream EDE Entity may leverage prior audit results that assessed some or all control
requirements listed in Exhibit 12 and Exhibit 13 of Appendix A of the EDE Guidelines, if the prior audit was
conducted within one year of the date of submission of the audit documentation to CMS. The EDE Guidelines are
available at the following link:
https://www.cms.gov/files/document/guidelines-enhanced-direct-enrollment-audits-year-6-final.pdf.
14

17

supplemental ORR audit package that contains the results of the supplemental
business requirements audit and/or privacy and security audit covering additional
functionality or systems implemented by or on behalf of the Hybrid Non-Issuer EDE
Entity (when required), must demonstrate the Hybrid Non-Issuer EDE Entity’s
compliance with applicable regulations, operational requirements, this Agreement,
and the ISA. The Hybrid Non-Issuer EDE Entity does not need to submit the Primary
EDE Entity’s ORR.
CMS considers any changes to the Primary EDE Entity’s approved EDE
Environment or the overall EDE End-User Experience beyond minor deviations for
branding to be the addition of functionality or systems to an approved EDE
Environment subject to the requirements of this Section. In all arrangements
permitted under this paragraph, the Hybrid Non-Issuer EDE Entity is responsible for
compliance with all of the requirements contained in all applicable regulations and
guidance, as well as in this Agreement. This includes oversight of the Primary EDE
Entity and ensuring its Primary EDE Entity’s EDE Environment complies with all
applicable regulations, including QHP display requirements as defined in 45 C.F.R.
§§ 155.220(c) and 155.221, operational requirements, this Agreement, and the ISA.
Any Primary EDE Entity supplying an EDE Environment to the Hybrid Non-Issuer
EDE Entity will be considered a Downstream or Delegated Entity of the Hybrid NonIssuer EDE Entity. A Hybrid Non-Issuer EDE Entity must identify its Primary EDE
Entity in the “Operational and Oversight Information” form provided by CMS. The
Hybrid Non-Issuer EDE Entity must have a contractual and legally binding
relationship with its Primary EDE Entity reflected in a signed, written agreement
between the Hybrid Non-Issuer EDE Entity and the Primary EDE Entity. The
Primary EDE Entity must identify inheritable Common Controls and Hybrid Controls
that the Hybrid Non-Issuer EDE Entity should leverage. The inherited Common
Controls and Hybrid Controls must be documented in the NEE SSP Template and
must also be documented as part of the written contract between the Primary EDE
Entity and the Hybrid Non-Issuer EDE Entity.
Depending on the additional functionality and systems added, the Hybrid Non-Issuer
EDE Entity may also need to onboard and register with CMS as a Web-broker. For
example, a Hybrid Non-Issuer EDE Entity that hosts its own QHP display or plan
shopping experience as part of the EDE End-User Experience must be registered with
CMS as a Web-broker.
The QHP display or plan shopping experience displayed in the EDE End-User
Experience provided to or operated by a Hybrid Non-Issuer EDE Entity must comply
with the requirements of 45 C.F.R. §§ 155.220 and 155.221.
When onboarding, annually during agreement renewal, and upon request, the Hybrid
Non-Issuer EDE Entity must provide CMS operational information, including, but not
limited to, its Designated Representative’s National Producer Number (NPN), State
licensure information, and information about its downstream agents/brokers, if
applicable. The Designated Representative designated by the Hybrid Non-Issuer EDE

18

Entity must have completed registration and, if applicable, training with the FFE
consistent with 45 C.F.R. § 155.220(d).
A Hybrid Non-Issuer EDE Entity operating under this provision cannot provide
access to its EDE Environment to an Issuer or another Hybrid Non-Issuer Upstream
EDE Entity.
IX.

FFE Eligibility Application and Enrollment Requirements.
a. FFE Eligibility Application End-State Phases and Phase-Dependent Screener
Questions. Appendix G describes each of the three end-state phases for hosting
applications using the EDE Pathway (Phase 1, Phase 2, and Phase 3). 16 EDE Entity
must select and implement an end-state phase. If EDE Entity has selected application
end-state Phase 1 or Phase 2, it must implement the requirements related to phasedependent screener questions set forth in Appendix C. In addition, EDE Entity must
meet any end-state phase-related communications requirements established by CMS.
EDE Entity must indicate the phase it has selected in the “Operational and Oversight
Information” form provided by CMS.
15F

The business requirements audit package EDE Entity submits to CMS must
demonstrate that EDE Entity’s EDE Environment meets all requirements associated
with EDE Entity’s selected phase, as set forth in Third-party Auditor Operational
Readiness Reviews for the Enhanced Direct Enrollment Pathway and Related
Oversight Requirements, 17 Enhanced Direct Enrollment API Companion Guide, 18
and FFE UI Application Principles for Integration with FFE APIs. 19 EDE Entity must
consult CMS prior to switching phases. If EDE Entity decides to switch to a different
phase after its Auditor has completed the business requirements audit, EDE Entity’s
Auditor must conduct portions of a revised business requirements audit to account for
the changes to the EDE Environment necessary to implement the new end-state phase
selected by EDE Entity to confirm compliance with all applicable requirements.
16F

17F

18F

b. EDE Entity Consumer, Applicant, Qualified Individual, or Enrollee—or these
individuals’ legal representatives or Authorized Representatives—Support for Term
of Agreement. EDE Entity’s EDE Environment must support Consumer-, Applicant-,
Qualified Individual-, or Enrollee—or these individuals’ legal representatives or
Authorized Representatives—reported Changes in Circumstances (CiCs), inclusive of
SEP CiCs and non-SEP CiCs, and SEPs within EDE Entity’s chosen end-state phase
for the full term of this Agreement, as well as supporting re-enrollment application
activities. Furthermore, all EDE Entities, regardless of the phase chosen, must support
households that wish to enroll in more than one enrollment group. Consistent with the
general expectations for EDE requirements—that the EDE requirements are
The table in Appendix G is an updated version of Exhibit 3 in the “Third-party Auditor Operational Readiness
Reviews for the Enhanced Direct Enrollment Pathway and Related Oversight Requirements.”
17
See supra note 8.
18
The document Enhanced Direct Enrollment API Companion Guide is available at the following link:
https://zone.cms.gov/document/api-information.
19
The document FFE UI Application Principles for Integration with FFE APIs is available at the following link:
https://zone.cms.gov/document/eligibility-information.
16

19

implemented for and provided to all users of an EDE Environment—Primary EDE
Entities must provide the functionalities described in this paragraph for all users of
the Primary EDE Entity’s EDE Environment, including any Upstream EDE Entities
and their users (e.g., Downstream Agents and Brokers).
If EDE Entity is no longer operating an EDE Environment, EDE Entity must direct
the Consumer, Applicant, Qualified Individual, or Enrollee—or these individuals’
legal representatives or Authorized Representatives—to the FFE (HealthCare.gov or
the Marketplace Call Center at 1-800-318-2596 [TTY: 1-855-889-4325]). EDE Entity
should take reasonable steps to continue supporting households that have used their
EDE Environment in the past to transfer to the new EDE Pathway. CMS suggests that
reasonable steps would include: send written notices to Consumers of the steps to
create an account/transfer their account to the different Primary EDE Entity, provide
the requisite information for them to create an account on that other site or carry their
information to a different pathway, and provide a notice on the site that EDE Entity
has transitioned its EDE Pathway to a different environment. EDE Entity can go
beyond these limited, minimum requirements in easing the Consumer transition to
[New Entity] and should follow the EDE Entity-initiated Change Request process as
described in Section IX.c of this Agreement for this functionality as appropriate
This provision survives the termination of the Agreement.
c. EDE Entity-initiated Modifications to EDE Environment (EDE Entity-initiated
Change Requests and EDE Entity-initiated Phase Change Requests). EDE Entity
must notify CMS immediately if it intends to make any change to its audited or
approved EDE Environment, including when EDE Entity opts to change to a different
EDE application phase (from its approved or audited EDE phase), consistent with the
processes and standards defined by CMS in the Change Notification Procedures for
Enhanced Direct Enrollment Information Technology Systems. 20 CMS excludes
changes made in response to an Auditor’s documented findings (if the findings were
submitted to CMS), to CMS technical assistance, or to resolve compliance findings
from being subject to the procedures detailed in the Change Notification Procedures
for Enhanced Direct Enrollment Information Technology Systems.
19F

d. CMS-initiated Modifications to EDE Program Requirements (CMS-initiated Change
Requests). CMS will periodically release updates to EDE program requirements in
the form of CMS-initiated Change Requests (CRs); these CMS-initiated CRs are
documented in the EDE Change Request Tracker. 21 EDE Entity must provide
specified documentation to CMS demonstrating its implementation of applicable
CMS-initiated CRs by the CMS-established deadline. EDE Entity must make any
CMS-mandated changes within the timeline established by CMS to make such
changes. If an EDE Entity does not timely submit documentation of its
20F

The document Change Notification Procedures for Enhanced Direct Enrollment Information Technology Systems
is available at the following link: https://zone.cms.gov/document/business-audit.
21
The EDE Change Request Tracker is located on CMS zONE: https://zone.cms.gov/document/business-audit.
20

20

implementation of such CRs, CMS may suspend the non-compliant EDE Entity’s
access to the EDE Pathway.
e. Maintenance of an Accurate Testing Environment. EDE Entity must maintain a
testing environment that accurately represents the EDE Entity’s production
environment and integration with the EDE Pathway, including functional use of all
EDE APIs. Approved and Prospective Phase Change EDE Entities must maintain at
least one testing environment that reflects their current production EDE environments
when developing and testing any prospective changes to their production EDE
environments. This will require Approved and Prospective Phase Change EDE
Entities to develop one or more separate environments (other than production and the
testing environment that reflects production) for developing and testing prospective
changes to their production environments. Network traffic into and out of all nonproduction environments is only permitted to facilitate system testing and must be
restricted by source and destination access control lists, as well as ports and protocols,
as documented in the NEE SSP, SA-11 implementation standard. The EDE Entity
shall not submit actual PII to the FFE Testing Environments. The EDE Entity shall
not submit test data to the FFE Production Environments. The EDE Entity’s testing
environments shall be readily accessible to applicable CMS staff and contractors via
the Internet to complete CMS audits.
EDE Entity must provide CMS, via the DE Help Desk, with a set of credentials and
any additional instructions necessary so that CMS can access the testing environment
that reflects the EDE Entity’s production environment to complete audits of the EDE
Entity’s EDE Environment. EDE Entity must ensure that the testing credentials are
valid and that all APIs and components of the EDE Environment in the testing
environment, including the remote identity proofing (RIDP) services, are accessible
for CMS to audit EDE Entity’s EDE Environment as determined necessary by CMS.
f. Penetration Testing. The EDE Entity must conduct penetration testing which
examines the network, application, device, and physical security of its EDE
Environment to discover weaknesses and identify areas where the security posture
needs improvement, and subsequently, ways to remediate the discovered
vulnerabilities. Before conducting the penetration testing, the EDE Entity must
execute a Rules of Engagement with their Auditor’s penetration testing team. The
EDE Entity must also notify their CMS designated technical counterparts on their
annual penetration testing schedule a minimum of five (5) business days prior to
initiation of the penetration testing using the CMS-provided form. 22 During the
penetration testing, the Auditor’s testing team shall not target IP addresses used for
the CMS and Non-CMS Organization connection and shall not conduct penetration
testing in the production environment. The penetration testing shall be conducted in
the lower environment that reflects the EDE Entity’s current production environment,
consistent with Section IX.e.
21F

The Penetration Testing Notification Form is available at the following links:
https://zone.cms.gov/document/privacy-and-security-audit.

22

21

g. Identity Proofing. EDE Entity must meet the identity proofing implementation
requirements set forth in Appendix C.
h. Accurate and Streamlined Eligibility Application UI. EDE Entity must meet the accurate
and streamlined eligibility application UI requirements set forth in Appendix C.
i. Post-Eligibility Application Communications. EDE Entity must provide account
management functions for Consumers, Applicants, Qualified Individuals, or Enrollees
—or these individuals’ legal representatives or Authorized Representatives— and
timely communicate with Consumers, Applicants, Qualified Individuals, or Enrollees
—or these individuals’ legal representatives or Authorized Representatives—
regarding their application and coverage status. EDE Entity must meet all
requirements related to post-eligibility application communications and account
management functions set forth in Appendix C. In addition to those requirements,
EDE Entity must update and report changes to the Consumer’s, Applicant’s,
Qualified Individual’s, or Enrollee’s application and enrollment information to the
FFE and must comply with future CMS guidance that elaborates upon EDE Entity’s
duties under this Agreement and applicable regulations.
j. Accurate Information About Exchanges and Consumer, Applicant, Qualified
Individual, or Enrollee Communications. EDE Entity must meet the requirements
related to providing to Consumers, Applicants, Qualified Individuals, or Enrollees—
or these individuals’ legal representatives or Authorized Representatives—accurate
information about Exchanges and the Consumer, Applicant, Qualified Individual, or
Enrollee communications requirements set forth in Appendix C. In addition, EDE
Entity must meet the marketing-related communications requirements defined by
CMS in the Third-party Auditor Operational Readiness Reviews for the Enhanced
Direct Enrollment Pathway and Related Oversight Requirements and the
Communications Toolkit. 23
22F

k. Documentation of Interactions with Consumer, Applicant, Qualified Individual, or
Enrollee Applications or the Exchange. EDE Entity must meet the requirements
related to documentation of interactions with Consumer, Applicant, Qualified
Individual, or Enrollee applications or the Exchange set forth in Appendix C.
l. Eligibility Results Testing and Standalone Eligibility Service (SES) Testing. EDE
Entity must meet the requirements related to eligibility results testing and SES testing
set forth in Appendix C.
m. API Functional Integration Requirements. EDE Entity must meet the API functional
integration requirements set forth in Appendix C.
n. Application UI Validation. EDE Entity must meet the application UI validation
requirements set forth in Appendix C.

The Communications Toolkit is stored within the Business Report Template and Toolkits file available at the
following link: https://zone.cms.gov/document/business-audit.
23

22

o. Section 508-compliant UI. EDE Entity must meet the 508-compliant UI requirements
set forth in Appendix C.
p. Non-English-Language Version of the Application UI and Communication Materials.
EDE Entity must translate the Application UI and any critical communications EDE
Entity sends Consumers, Applicants, Qualified Individuals, or Enrollees—or these
individuals’ legal representatives or Authorized Representatives—in relation to their
use of its EDE Environment into any non-English language that is spoken by an LEP
population that reaches ten percent or more of the population of the relevant State as
set forth in Appendix C.
q. Correction of Consumer, Applicant, Qualified Individual, or Enrollee Application
Information. If EDE Entity identifies issues in its EDE Environment constituting
noncompliance with the EDE program requirements as documented in Section IX of
this Agreement that may affect the accuracy of a Consumer’s, Applicant’s, Qualified
Individual’s, or Enrollee’s Application Information—including the Exchange’s
eligibility determination or enrollment status—EDE Entity must notify CMS
immediately by email to directenrollment@cms.hhs.gov. For any such issues identified
by EDE Entity or CMS, EDE Entity must provide CMS-requested data on a timeline
established by CMS. CMS-requested data includes all data that CMS deems
necessary to determine the scope of the issues and identify potentially affected
Consumers, Applicants, Qualified Individuals, or Enrollees, including records
maintained by EDE Entity consistent with Section IX.k of this Agreement. EDE
Entity must provide assistance to CMS to identify the population of Consumers,
Applicants, Qualified Individuals, or Enrollees potentially affected by the identified
issues. EDE Entity must remedy CMS- or EDE Entity-identified issues in EDE
Entity’s EDE Environment in a manner and timeline subject to CMS’ approval. CMS
may require that EDE Entity submit updated application information within thirty (30)
Days to correct inaccuracies in previously submitted applications. CMS may require
that EDE Entity conduct necessary CMS-approved outreach to notify the potentially
affected Consumers, Applicants, Qualified Individuals, or Enrollees of any action
required by the Consumers, Applicants, Qualified Individuals, or Enrollees, if
applicable, and of any changes in eligibility or enrollment status as a result of the
issues.
r. Agent/Broker Identity Proofing Requirements. EDE Entity must implement Agent
and Broker identity verification procedures that consist of the following requirements:
1. EDE Entity must provide the User ID of the requester in each EDE API call. For
Agents and Brokers, the User ID must exactly match the FFE-assigned User-ID
for the Agent or Broker using the EDE Environment or the request will fail FFE
User ID validation. 24 As a reminder, for Consumers, Applicants, Qualified
Individuals, or Enrollees—or these individuals’ legal representatives or
Authorized Representatives—the User ID should be the account User ID for the
23F

In order for an Agent or Broker to obtain and maintain an FFE User ID, the Agent or Broker must complete
registration and training with the Exchange annually.
24

23

Consumer, Applicant, Qualified Individual, or Enrollee or a distinct identifier for
the Consumer, Applicant, Qualified Individual, or Enrollee.
2. EDE Entity must identity proof all Agents and Brokers prior to allowing the
Agents and Brokers to use the EDE Environment. EDE Entity may conduct
identity proofing in one of the following ways:
a. Use the FFE-provided Remote Identity Proofing/Fraud Solutions Archive
Reporting Service (RIDP/FARS) or a Federal Identity, Credential, and Access
Management (FICAM) Trust Framework Solutions (TFS)-approved service to
remotely identity-proof Agents and Brokers; OR
b. Manually identity-proof Agents and Brokers following the guidelines outlined
in the document “Acceptable Documentation for Identity Proofing.” 25
24F

3. EDE Entity must validate an Agent’s or Broker’s National Producer number
(NPN) using the National Insurance Producer Registry (https://www.nipr.com)
prior to allowing the Agent or Broker to use the EDE Environment.
4. EDE Entity must review the Agent/Broker Suspension and Termination list prior
to allowing the Agent or Broker to initially use the EDE Environment. 26
25F

5. If EDE Entity does not provide Agent or Broker identity proofing functionality
consistent with the requirements above, EDE Entity cannot provide access to its
EDE Environment to third-party Agents or Brokers. Furthermore, if a Primary
EDE Entity does not provide Agent or Broker identity proofing functionality
consistent with the requirements above, any Upstream EDE Entities that wish to
use the Agent or Broker EDE Pathway must implement an Agent or Broker
identity proofing approach consistent with these requirements prior to offering
Agents or Brokers access to their EDE Environments. In such cases, the Upstream
EDE Entities must contract with an independent Auditor to conduct an audit to
evaluate the Agent or Broker identity proofing requirements consistent with this
Section, and submit the audit to CMS for approval.
6. EDE Entity is strongly encouraged to implement multi-factor authentication for
Agents and Brokers that is consistent with NIST SP 800-63-3.
7. EDE Entity must not permit Agents and Brokers using the EDE Environment to
share access control credentials.
s. Implement Full EDE API Suite of Required Services. EDE Entity must implement
the full EDE API suite of required services, regardless of EDE Entity’s chosen
application end-state phase. The suite of required services consists of the following
APIs: Store ID Proofing, Person Search, Create App, Create App from Prior Year
25
The document Acceptable Documentation for Identity Proofing is available on CMS zONE at the following link:
https://zone.cms.gov/document/enhanced-direct-enrollment-ede-documents-and-materials.
26
The Agent/Broker Suspension and Termination List is available at: https://data.healthcare.gov/ab-suspension-andtermination-list.

24

App, Store Permission, Revoke Permission, Get App, Add Member, Remove
Member, Update App, Submit App, Get Data Matching Issue (DMI), Get Special
Enrollment Period Verification Issue (SVI), Metadata Search, Notice Retrieval,
Submit Enrollment, Document Upload, System and State Reference Data, Get
Enrollment, Payment Redirect 27, Update Policy, and Event-Based Processing (EBP).
CMS may release additional required or optional APIs during the term of this
Agreement. If CMS releases a required API, the change will be considered a CMSinitiated Change Request consistent with Section IX.d of this Agreement.
26F

t. Maintain Full EDE API Suite of Required Services. In addition to any CMS-initiated
Change Requests, CMS may make technical updates to Exchange systems or APIs
that may affect EDE Entity’s use of the EDE APIs. In order to maintain a functional
EDE Environment and avoid errors or discrepancies when submitting data to and
receiving data from the Exchange, EDE Entity must maintain an EDE Environment
that implements changes as needed and documented in EDE technical documentation
provided by CMS. 28
27F

u. Health Reimbursement Arrangement (HRA) Offer Disclaimer. EDE Entity must
implement disclaimers for Qualified Individuals who have an HRA offer that is
tailored to the type and affordability of the HRA offered to the Qualified Individuals
consistent with CMS guidance. Disclaimers for various scenarios are detailed in the
FFEs DE API for Web-brokers/Issuers Technical Specifications document. 29
28F

v. Inactive, Approved Primary EDE Entities to Demonstrate Operational Readiness and
Compliance. In order for an approved Primary EDE Entity to maintain status as an
approved Primary EDE Entity during the annual renewal process for this Agreement,
EDE Entity must demonstrate a history of enrollments completed via EDE during the
term of the prior year’s Agreement if the approved Primary EDE Entity has been
approved for at least one year as determined by the date of the initial approval of the
Primary EDE Entity and initial execution of the ISA. If the EDE Entity has been
approved for at least one year and does not have a history of enrollments completed
via EDE during the term of the prior year’s Agreement, EDE Entity must demonstrate
operational readiness and compliance with applicable requirements as documented in
the EDE Guidelines in order to continue to participate as an approved Primary EDE
Entity. Under this section, CMS may withhold execution of the subsequent plan
year’s Agreement and ISA or delay approval of an Upstream EDE Entity until EDE
Entity has demonstrated operational readiness and compliance with applicable
requirements to CMS’s satisfaction.

For information on exceptions to the requirement for EDE Entities to integrate with the Payment Redirect API,
see Section 13.3, Payment Redirect Integration Requirements, of the EDE API Companion Guide, available at the
following link: https://zone.cms.gov/document/api-information.
28
EDE APIs technical documentation is available on CMS zONE at the following link:
https://zone.cms.gov/document/api-information.
29
The document Direct Enrollment API Specs is available on CMS zONE at the following link:
https://zone.cms.gov/document/direct-enrollment-de-documents-and-materials.
27

25

X.

Miscellaneous.
a. Notice. All notices to Parties specifically required under this Agreement shall be
given in writing and shall be delivered as follows:
If to CMS:
By email:
directenrollment@cms.hhs.gov
By mail:
Centers for Medicare & Medicaid Services (CMS)
Center for Consumer Information and Insurance Oversight (CCIIO)
Attn: Office of the Director
Room 739H
200 Independence Avenue, SW
Washington, DC 20201
If to EDE Entity, to EDE Entity’s primary contact’s email address on record.
Notices sent by hand or overnight courier service, or mailed by certified or registered
mail, shall be deemed to have been given when received; notices sent by email shall
be deemed to have been given when the appropriate confirmation of receipt has been
received; provided that notices not given on a business day (i.e., Monday-Friday
excluding federal holidays) between 9:00 a.m. and 5:00 p.m. local time where the
recipient is located shall be deemed to have been given at 9:00 a.m. on the next
business day for the recipient. A Party to this Agreement may change its contact
information for notices and other communications by providing written notice of such
changes in accordance with this provision. Such notice should be provided thirty (30)
Days in advance of such change, unless circumstances warrant a shorter timeframe.
b. Assignment and Subcontracting. Except as otherwise provided in this Section, EDE
Entity shall not assign this Agreement in whole or in part, whether by merger,
acquisition, consolidated, reorganization, or otherwise any portion of the services to
be provided by EDE Entity under this Agreement without the express, prior written
consent of CMS, which consent may be withheld, conditioned, granted, or denied in
CMS’ sole discretion. EDE Entity must provide written notice at least thirty (30)
Days prior to any such proposed assignment, including any change in ownership of
EDE Entity or any change in management or ownership of the EDE Environment.
Notwithstanding the foregoing, CMS does not require prior written consent for
subcontracting arrangements that do not involve the operation, management, or
control of the EDE Environment. EDE Entity must report all subcontracting
arrangements on its annual Operational and Oversight Information form during the
annual EDE Agreement Renewal process and submit revisions annually thereafter.
EDE Entity shall assume ultimate responsibility for all services and functions
described under this Agreement, including those that are subcontracted to other
entities, and must ensure that subcontractors will perform all functions in accordance
with all applicable requirements. EDE Entity shall further be subject to such oversight
and enforcement actions for functions or activities performed by subcontractors as
may otherwise be provided for under applicable law and program requirements,
26

including EDE Entity’s respective agreement(s) with CMS (including the QHP Issuer
Agreement or the Web-broker Agreement). Notwithstanding any subcontracting of
any responsibility under this Agreement, EDE Entity shall not be released from any
of its performance or compliance obligations hereunder, and shall remain fully bound
to the terms and conditions of this Agreement as unaltered and unaffected by such
subcontracting.
If EDE Entity attempts to make an assignment, subcontracting arrangement or
otherwise delegate its obligations hereunder in violation of this provision, such
assignment, subcontract, or delegation shall be deemed void ab initio and of no force
or effect, and EDE Entity shall remain legally bound hereto and responsible for all
obligations under this Agreement.
c. Use of the FFE Web Services. EDE Entity will only use a CMS-approved EDE
Environment when accessing the APIs and web services that facilitate EDE
functionality to enroll Consumers, Applicants, Qualified Individuals, or Enrollees—
or these individuals’ legal representatives or Authorized Representatives—through
the FFEs and SBE-FPs, which includes compliance with the requirements detailed in
Appendix H.
d. Incident Reporting Procedures: EDE Entity must implement Incident and Breach
Handling procedures as required by the NEE SSP and that are consistent with CMS’s
Incident and Breach Notification Procedures. Such policies and procedures must
identify EDE Entity’s Designated Security and Privacy Official(s), if applicable,
and/or identify other personnel authorized to access PII and responsible for reporting
to CMS and managing Incidents or Breaches and provide details regarding the
identification, response, recovery, and follow-up of Incidents and Breaches, which
should include information regarding the potential need for CMS to immediately
suspend or revoke access to the Hub for containment purposes. EDE Entity agrees to
report any Breach of PII to the CMS IT Service Desk by telephone at (410) 786-2580
or 1-800-562-1963 or via email notification at cms_it_service_desk@cms.hhs.gov
within 24 hours from knowledge of the Breach. Incidents must be reported to the
CMS IT Service Desk by the same means as Breaches within 72 hours from
knowledge of the Incident.
e. Survival. EDE Entity’s obligation under this Agreement to protect and maintain the
privacy and security of PII and any other obligation of EDE Entity in this Agreement
which, by its express terms or nature and context is intended to survive expiration or
termination of this Agreement, shall survive the expiration or termination of this
Agreement.
f. Severability. The invalidity or unenforceability of any provision of this Agreement
shall not affect the validity or enforceability of any other provision of this Agreement.
In the event that any provision of this Agreement is determined to be invalid,
unenforceable or otherwise illegal, such provision shall be deemed restated, in
accordance with applicable law, to reflect as nearly as possible the original intention
of the Parties, and the remainder of the Agreement shall be in full force and effect.

27

g. Disclaimer of Joint Venture. Neither this Agreement nor the activities of EDE Entity
contemplated by and under this Agreement shall be deemed or construed to create in
any way any partnership, joint venture, or agency relationship between CMS and
EDE Entity. Neither Party is, nor shall either Party hold itself out to be, vested with
any power or right to bind the other Party contractually or to act on behalf of the other
Party, except to the extent expressly set forth in the ACA and the regulations codified
thereunder, including as codified at 45 C.F.R. part 155.
h. Remedies Cumulative. No remedy herein conferred upon or reserved to CMS under
this Agreement is intended to be exclusive of any other remedy or remedies available
to CMS under operative law and regulation, and each and every such remedy, to the
extent permitted by law, shall be cumulative and in addition to any other remedy now
or hereafter existing at law or in equity or otherwise.
i. Records. EDE Entity shall maintain all records that it creates in the normal course of
its business in connection with activity under this Agreement for the term of this
Agreement in accordance with 45 C.F.R. §§ 155.220(c)(3)(i)(E) or 156.705(c), as
applicable. Subject to applicable legal requirements and reasonable policies, such
records shall be made available to CMS to ensure compliance with the terms and
conditions of this Agreement. The records shall be made available during regular
business hours at EDE Entity’s offices, and CMS’s review shall not interfere
unreasonably with EDE Entity’s business activities. This clause survives the
expiration or termination of this Agreement.
j. Compliance with Law. EDE Entity covenants and agrees to comply with any and all
applicable laws, statutes, regulations, or ordinances of the United States of America
and any Federal Government agency, board, or court that are applicable to the
conduct of the activities that are the subject of this Agreement, including, but not
necessarily limited to, any additional and applicable standards required by statute, and
any regulations or policies implementing or interpreting such statutory provisions
hereafter issued by CMS. In the event of a conflict between the terms of this
Agreement and any statutory, regulatory, or sub-regulatory guidance released by
CMS, the requirement that constitutes the stricter, higher, or more stringent level of
compliance shall control.
k. Governing Law and Consent to Jurisdiction. This Agreement will be governed by the
laws and common law of the United States of America, including without limitation
such regulations as may be promulgated by HHS or any of its constituent agencies,
without regard to any conflict of laws statutes or rules. EDE Entity further agrees and
consents to the jurisdiction of the Federal Courts located within the District of
Columbia and the courts of appeal therefrom, and waives any claim of lack of
jurisdiction or forum non conveniens.
l. Amendment. CMS may amend this Agreement for purposes of reflecting changes in
applicable law or regulations, with such amendments taking effect upon thirty (30)
Days’ written notice to EDE Entity (“CMS notice period”), unless circumstances
warrant an earlier effective date. Any amendments made under this provision will
only have prospective effect and will not be applied retrospectively. EDE Entity may
reject such amendment by providing to CMS, during the CMS notice period, written
28

notice of its intent to reject the amendment (“rejection notice period”). Any such
rejection of an amendment made by CMS shall result in the termination of this
Agreement upon expiration of the rejection notice period.
m. Audit and Compliance Review. EDE Entity agrees that CMS, the Comptroller
General, the Office of the Inspector General of HHS, or their designees may conduct
compliance reviews or audits, which includes the right to interview employees,
contractors, and business partners of EDE Entity and to audit, inspect, evaluate,
examine, and make excerpts, transcripts, and copies of any books, records,
documents, and other evidence of EDE Entity’s compliance with the requirements of
this Agreement and applicable program requirements upon reasonable notice to EDE
Entity, during EDE Entity’s regular business hours, and at EDE Entity’s regular
business location. These audit and review rights include the right to audit EDE
Entity’s compliance with and implementation of the privacy and security
requirements under this Agreement, the ISA, EDE Entity’s respective agreement(s)
with CMS (including the QHP Issuer Agreement or the Web-broker Agreement), and
applicable program requirements. EDE Entity further agrees to allow reasonable
access to the information and facilities, including, but not limited to, EDE Entity
website testing environments, requested by CMS, the Comptroller General, the Office
of the Inspector General of HHS, or their designees for the purpose of such a
compliance review or audit. EDE Entity is also responsible for ensuring cooperation
by its Downstream and Delegated Entities, including EDE Entity’s subcontractors
and assignees, as well as the Auditor(s) and any of its subcontractors, with audits and
reviews. CMS may suspend or terminate this Agreement if EDE Entity does not
comply with such a compliance review request within seven (7) business days. If any
of EDE Entity’s obligations under this Agreement are delegated to other parties, the
EDE Entity’s agreement with any Downstream and Delegated Entities must
incorporate this Agreement provision.
This clause survives the expiration or termination of this Agreement.
n. Access to the FFEs and SBE-FPs. EDE Entity; its Downstream and Delegated
Entities, including downstream Agents/Brokers; and its assignees or subcontractors—
including, employees, developers, agents, representatives, or contractors—cannot
remotely connect or transmit data to the FFE, SBE-FP or its testing environments, nor
remotely connect or transmit data to EDE Entity’s systems that maintain connections
to the FFE, SBE-FP or its testing environments, from locations outside of the United
States of America or its territories, embassies, or military installations. This includes
any such connection through virtual private networks (VPNs).

[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]

29

This “Agreement between EDE Entity and the Centers for Medicare & Medicaid Services
for the Individual Market Federally-facilitated Exchanges and State-based Exchanges on
the Federal Platform” has been signed and executed by:
TO BE FILLED OUT BY EDE ENTITY
The undersigned is an authorized official of EDE Entity who is authorized to represent and
bind EDE Entity for purposes of this Agreement. The undersigned attests to the accuracy
and completeness of all information provided in this Agreement.

Signature of Authorized Official of EDE Entity

Date

Printed Name and Title of Authorized Official of EDE Entity

EDE Entity Partner IDs

EDE Entity Name

Signature of Privacy Officer

Printed Name and Title of Privacy Officer

EDE Entity Address

EDE Entity Contact Number

30

FOR CMS
The undersigned are officials of CMS who are authorized to represent and bind CMS for
purposes of this Agreement.

Jeffrey D. Grant
Deputy Director for Operations
Center for Consumer Information and Insurance Oversight
Centers for Medicare & Medicaid Services

Date

George C. Hoffmann
Deputy CIO and Deputy Director
Office of Information Technology (OIT)
Centers for Medicare & Medicaid Services (CMS)

Date

31

APPENDIX A: PRIVACY AND SECURITY STANDARDS AND IMPLEMENTATION
SPECIFICATIONS FOR NON-EXCHANGE ENTITIES
Federally-facilitated Exchanges (“FFEs”) will enter into contractual agreements with all NonExchange Entities, including EDE Entities, that gain access to Personally Identifiable
Information (“PII”) exchanged with the FFEs (including FF-SHOPs) and State-based
Exchanges on the Federal Platform (“SBE-FPs”) (including SBE-FP-SHOPs), or directly from
Consumers, Applicants, Qualified Individuals, Enrollees, Qualified Employees, and Qualified
Employers, or these individuals’ legal representatives or Authorized Representatives. This
Agreement and its appendices govern any PII that is created, collected, disclosed, accessed,
maintained, stored, or used by EDE Entities in the context of the FFEs and SBE-FPs. In signing
this contractual Agreement, in which this Appendix A has been incorporated, EDE Entities
agree to comply with the security and privacy standards and implementation specifications
outlined in the Non-Exchange Entity System Security and Privacy Plan (“NEE SSP”) 30 and
Section A 31 below while performing the Authorized Functions outlined in their respective
Agreement(s) with CMS.
29F

30F

The standards documented in the NEE SSP and Section A below are established in accordance
with Section 1411(g) of the Affordable Care Act (“ACA”) (42 U.S.C. § 18081(g)), the Federal
Information Management Act of 2014 (“FISMA”) (44 U.S.C. 3551), and 45 C.F.R. § 155.260
and are consistent with the principles in 45 C.F.R. §§ 155.260(a)(1) through (a)(6). All capitalized
terms used herein carry the meanings assigned in Appendix B: Definitions. Any capitalized term
that is not defined in the Agreement, this Appendix or in Appendix B: Definitions has the
meaning provided in 45 C.F.R. § 155.20.
A.

NON-EXCHANGE ENTITY PRIVACY AND SECURITY IMPLEMENTATION
SPECIFICATIONS

Non-Exchange Entities must meet privacy and security implementation specifications that are
consistent with the Health Insurance Portability and Accountability Act (HIPAA) of 1996 P.L.
104-191 and the Privacy Act of 1974, 5 U.S.C. § 552a, including:
(1) Openness and Transparency. In keeping with the standards and implementation
specifications used by the FFEs, a Non-Exchange Entity must ensure openness and
transparency about policies, procedures, and technologies that directly affect
Consumers, Applicants, Qualified Individuals, and Enrollees and their PII.
a. Standard: Privacy Notice Statement. Prior to collecting PII, the Non-Exchange
Entity must provide a notice that is prominently and conspicuously displayed on a
public-facing website, if applicable, or on the electronic and/or paper form the
30
The NEE SSP template is located on CMS zONE at the following link: https://zone.cms.gov/document/privacyand-security-audit.
31
Section A contains excerpts from the NEE SSP of two requirements for ease of reference. This does not alter the
need to comply with other applicable EDE Entity requirements, including those outlined within 45 C.F.R. §
155.260(a)(1) through (a)(6) or the NEE SSP.

32

Non-Exchange Entity will use to gather and/or request PII. The EDE Entity must
comply with any additional standards and implementation specifications
described in NEE SSP TR-1: Privacy Notice.
i.

Implementation Specifications.
1. The statement must be written in plain language and provided in a manner
that is timely and accessible to people living with disabilities and with
limited English proficiency.
2. The statement must contain at a minimum the following information:
a. Legal authority to collect PII;
b. Purpose of the information collection;
c. To whom PII might be disclosed, and for what purposes;
d. Authorized uses and disclosures of any collected information;
e. Whether the request to collect PII is voluntary or mandatory under the
applicable law; and
f. Effects of non-disclosure if an individual chooses not to provide the
requested information.
3. The Non-Exchange Entity shall maintain its Privacy Notice Statement
content by reviewing and revising as necessary on an annual basis, at a
minimum, and before or as soon as possible after any change to its privacy
policies and procedures.
4. If the Non-Exchange Entity operates a website, it shall ensure that
descriptions of its privacy and security practices, and information on how
to file complaints with CMS and the Non-Exchange Entity, are publicly
available through its website. 32
31F

(2) Individual Choice. In keeping with the standards and implementation specifications
used by the FFEs, the Non-Exchange Entity should ensure that Consumers,
Applicants, Qualified Individuals, and Enrollees—or these individuals’ legal
representatives or Authorized Representatives—are provided a reasonable
opportunity and capability to make informed decisions about the creation, collection,
disclosure, access, maintenance, storage, and use of their PII.
a. Standard: Informed Consent. The Non-Exchange Entity may create, collect,
disclose, access, maintain, store, and use PII from Consumers, Applicants,
Qualified Individuals, and Enrollees—or these individuals’ legal representatives
or Authorized Representatives—only for the functions and purposes listed in the
CMS recommends that EDE Entities direct consumers, who are seeking to file a complaint, to the Secretary of the
U.S. Department of Health and Human Services, 200 Independence Ave, S.W., Washington, D.C. 20201. Call (202)
619-0257 (or toll free (877) 696-6775) or go to the website of the Office for Civil Rights, www.hhs.gov/ocr/hipaa.

32

33

Privacy Notice Statement and any relevant agreements in effect as of the time the
information is collected, unless the FFE, SBE-FP, or Non-Exchange Entity
obtains informed consent from such individuals. The EDE Entity must comply
with any additional standards and implementation specifications described in
NEE SSP IP-1: Consent.
i.

Implementation Specifications.
1. The Non-Exchange Entity must obtain informed consent from individuals
for any use or disclosure of information that is not permissible within the
scope of the Privacy Notice Statement and any relevant agreements that
were in effect as of the time the PII was collected. Such consent must be
subject to a right of revocation.
2. Any such consent that serves as the basis of a use or disclosure must:
a. Be provided in specific terms and in plain language,
b. Identify the entity collecting or using the PII, and/or making the
disclosure,
c. Identify the specific collections, use(s), and disclosure(s) of specified
PII with respect to a specific recipient(s), and
d. Provide notice of an individual’s ability to revoke the consent at any
time.
3. Consent documents must be appropriately secured and retained for ten
(10) Years.

34

APPENDIX B: DEFINITIONS
This Appendix defines terms that are used in the Agreement and other Appendices. Any
capitalized term used in the Agreement that is not defined therein or in this Appendix has the
meaning provided in 45 C.F.R. § 155.20.
(1)

Advance Payments of the Premium Tax Credit (APTC) has the meaning set forth
in 45 C.F.R. § 155.20.

(2)

Affordable Care Act (ACA) means the Affordable Care Act (Public Law 111-148),
as amended by the Health Care and Education Reconciliation Act of 2010 (Public
Law 111-152), which are referred to collectively as the Affordable Care Act or ACA.

(3)

Agent or Broker has the meaning set forth in 45 C.F.R. § 155.20.

(4)

Agent or Broker Direct Enrollment (DE) Technology Provider has the meaning
set forth in 45 C.F.R. § 155.20.

(5)

Applicant has the meaning set forth in 45 C.F.R. § 155.20.

(6)

Auditor means a person or organization that meets the requirements set forth in this
Agreement and contracts with a Direct Enrollment (DE) Entity for the purposes of
conducting an Operational Readiness Review (ORR) in accordance with 45 C.F.R. §§
155.221(b)(4) and (f), this Agreement and CMS-issued guidance.

(7)

Authorized Function means a task performed by a Non-Exchange Entity that the
Non-Exchange Entity is explicitly authorized or required to perform based on
applicable law or regulation, and as enumerated in the Agreement that incorporates
this Appendix B.

(8)

Authorized Representative means a person or organization meeting the
requirements set forth in 45 C.F.R. § 155.227.

(9)

Breach has the meaning contained in OMB Memoranda M-17-12 (January 3, 2017),
and means the loss of control, compromise, unauthorized disclosure, unauthorized
acquisition, or any similar occurrence where (1) a person other than an authorized
user accesses or potentially accesses Personally Identifiable Information or (2) an
authorized user accesses or potentially accesses Personally Identifiable Information
for anything other than an authorized purpose.

(10) CCIIO means the Center for Consumer Information and Insurance Oversight within
the Centers for Medicare & Medicaid Services (CMS).
(11) Classic Direct Enrollment (Classic DE) means, for purposes of this Agreement, the
original version of Direct Enrollment, which utilizes a double redirect from a Direct
Enrollment (DE) Entity’s website to HealthCare.gov where the eligibility application
is submitted and an eligibility determination is received, and back to the DE Entity’s

35

website for QHP shopping and plan selection consistent with applicable requirements
in 45 C.F.R. §§ 155.220(c)(3)(i), 155.221, 156.265 and/or 156.1230(b).
(12) Classic Direct Enrollment Pathway (Classic DE Pathway) means, for the purposes
of this Agreement, the application and enrollment process used by Direct Enrollment
(DE) Entities for Classic DE.
(13) CMS means the Centers for Medicare & Medicaid Services.
(14) CMS Companion Guides means a CMS-authored guide, available on the CMS
website, which is meant to be used in conjunction with and supplement relevant
implementation guides published by the Accredited Standards Committee.
(15) CMS Data Services Hub (Hub) is the CMS Federally-managed service to interface
data among connecting entities, including HHS, certain other Federal agencies, and
State Medicaid agencies.
(16) CMS Data Services Hub Web Services (Hub Web Services) means business and
technical services made available by CMS to enable the determination of certain
eligibility and enrollment or federal financial payment data through the Federallyfacilitated Exchange (FFE) website, including the collection of personal and financial
information necessary for Consumer, Applicant, Qualified Individual, or Enrollee
account creations; Qualified Health Plan (QHP) application submissions; and
Insurance Affordability Program eligibility determinations.
(17) Common Control means a security or privacy control whose implementation results
in a security or privacy capability that is inheritable by multiple information systems
being served by the Primary EDE Entity.
(18) Consumer means a person who, for himself or herself, or on behalf of another
individual, seeks information related to eligibility or coverage through a Qualified
Health Plan (QHP) offered through an Exchange or Insurance Affordability Program,
or whom an Agent or Broker (including Web-brokers) registered with the FFE,
Navigator, Issuer, Certified Application Counselor, or other entity assists in applying
for a QHP, applying for APTC and CSRs, and/or completing enrollment in a QHP
through the FFEs or State-based Exchanges on the Federal Platform (SBE-FPs) for
individual market coverage.
(19) Cost-sharing Reductions (CSRs) has the meaning set forth in 45 C.F.R. § 155.20.
(20) Customer Service means assistance regarding eligibility and Health Insurance
Coverage provided to a Consumer, Applicant, Qualified Individual, and Enrollee,
including, but not limited to, responding to questions and complaints; providing
information about eligibility; applying for APTC and/or CSRs, and Health Insurance
Coverage; and explaining enrollment processes in connection with the FFEs or SBEFPs.
(21) Day or Days means calendar days, unless otherwise expressly indicated in the
relevant provision of the Agreement that incorporates this Appendix B.

36

(22)

Delegated Entity means, for purposes of this Agreement, any party, including an
Agent or Broker, that enters into an agreement with an Enhanced Direct Enrollment
(EDE Entity) to provide administrative or other services to or on behalf of the EDE
Entity or to provide administrative or other services to Consumers and their
dependents.

(23) Designated Privacy Official means a contact person or office responsible for
receiving complaints related to Breaches or Incidents, able to provide further
information about matters covered by the Privacy Notice statement, responsible for
the development and implementation of the privacy policies and procedures of the
Non-Exchange Entity, and ensuring the Non-Exchange Entity has in place
appropriate safeguards to protect the privacy of Personally Identifiable Information
(PII).
(24) Designated Representative means an Agent or Broker that has the legal authority to
act on behalf of the Web-broker.
(25) Designated Security Official means a contact person or office responsible for the
development and implementation of the security policies and procedures of the NonExchange Entity and ensuring the Non-Exchange Entity has in place appropriate
safeguards to protect the security of Personally Identifiable Information (PII).
(26)

Direct Enrollment (DE) means, for the purposes of this Agreement, the process by
which a Direct Enrollment (DE) Entity may assist an Applicant or Enrollee with
enrolling in a QHP in a manner that is considered through the Exchange consistent
with applicable requirements in 45 C.F.R. §§ 155.220(c), 155.221, 156.265, and/or
156.1230. Direct Enrollment is the collective term used when referring to both
Classic Direct Enrollment and Enhanced Direct Enrollment.

(27) Direct Enrollment (DE) Entity has the meaning set forth in 45 C.F.R. § 155.20.
(28) Direct Enrollment Entity Application Assister has the meaning set forth in 45
C.F.R. § 155.20.
(29) Direct Enrollment (DE) Environment means an information technology application
or platform provided, owned, and maintained by a DE Entity through which a DE
Entity establishes an electronic connection with the Hub and, utilizing a suite of CMS
APIs, submits Consumer, Applicant, Qualified Individual, or Enrollee information to
the FFE for the purpose of assisting Consumers, Applicants, Qualified Individuals,
and Enrollees—or these individuals’ legal representatives or Authorized
Representatives—in applying for APTC and/or CSRs; applying for enrollment in
QHPs offered through an FFE or SBE-FP; or completing enrollment in QHPs offered
through an FFE or SBE-FP.
(30) Downstream Entity means, for purposes of this Agreement, any party, including an
Agent or Broker, that enters into an agreement with a Delegated Entity or with
another Downstream Entity for purposes of providing administrative or other services
related to the agreement between the Delegated Entity and the Enhanced Direct
Enrollment (EDE) Entity. The term “Downstream Entity” is intended to refer to the
37

entity that directly provides administrative services or other services to or on behalf
of the EDE Entity or that provides administrative or other services to Consumers and
their dependents.
(31) Downstream White-Label Third-Party User Arrangements means an arrangement
between an Agent or Broker and a Primary EDE Entity to use the Primary EDE
Entity’s EDE Environment. In this arrangement, a Primary EDE Entity enables the
Downstream White-Label Agent or Broker to only make minor branding changes to
the Primary EDE Entity’s EDE Environment.
(32) Enhanced Direct Enrollment (EDE) means, for purposes of this Agreement, the
version of Direct Enrollment which allows Consumers, Applicants, Qualified
Individuals, or Enrollees—or these individuals’ legal representatives or Authorized
Representatives—to complete all steps in the application, eligibility and enrollment
processes on an EDE Entity’s website consistent with applicable requirements in 45
C.F.R. §§ 155.220(c)(3)(ii), 155.221, 156.265 and/or 156.1230(b) using application
programming interfaces (APIs) as provided, owned, and maintained by CMS to
transfer data between the Exchange and the EDE Entity’s website.
(33)

Enhanced Direct Enrollment (EDE) End-User Experience means all aspects of
the pre-application, application, enrollment, and post-enrollment experience and any
data collected necessary for those steps or for the purposes of any Authorized
Functions under this Agreement.

(34) Enhanced Direct Enrollment (EDE) Entity means a DE Entity that has been
approved by CMS to use the EDE Pathway. This term includes both Primary EDE
Entities and Upstream EDE Entities.
(35) Enhanced Direct Enrollment (EDE) Environment means an information
technology application or platform provided, owned, and maintained by an EDE
Entity through which an EDE Entity establishes an electronic connection with the
Hub and, utilizing a suite of CMS APIs, submits Consumer, Applicant, Qualified
Individual, or Enrollee—or these individuals’ legal representatives or Authorized
Representatives—information to the FFE for the purpose of assisting Consumers,
Applicants, Qualified Individuals, and Enrollees—or these individuals’ legal
representatives or Authorized Representatives—in applying for APTC and/or CSRs;
applying for enrollment in QHPs offered through an FFE or SBE-FP; or completing
enrollment in QHPs offered through an FFE or SBE-FP.
(36) Enhanced Direct Enrollment (EDE) Pathway means the APIs and functionality
comprising the systems that enable EDE as provided, owned, and maintained by
CMS.
(37) Enrollee has the meaning set forth in 45 C.F.R. § 155.20.
(38) Exchange has the meaning set forth in 45 C.F.R. § 155.20.
(39) Federally-facilitated Exchange (FFE) means an Exchange (or Marketplace)
established by the Department of Health and Human Services (HHS) and operated by
38

CMS under Section 1321(c)(1) of the ACA for individual market coverage.
Federally-facilitated Marketplaces (FFMs) has the same meaning as FFEs.
(40) Health Insurance Coverage has the meaning set forth in 45 C.F.R. § 155.20.
(41) Health Insurance Portability and Accountability Act (HIPAA) means the Health
Insurance Portability and Accountability Act of 1996, Pub. L. No. 104-191, as
amended, and its implementing regulations.
(42) Health Reimbursement Arrangement (HRA) has the meaning set forth in 45
C.F.R. § 146.123(c).
(43) HHS means the United States Department of Health & Human Services.
(44) Hybrid Control means those controls for which both a Primary EDE Entity and its
Upstream EDE Entity share the responsibility of implementing the full control
objectives and implementation standards. Hybrid Controls refer to arrangements in
which an Upstream EDE Entity information system inherits part of a control from a
Primary EDE Entity, with the remainder of the control provided by the Upstream
EDE Entity leveraging the Primary EDE Entity’s EDE Environment.
(45) Hybrid Issuer Upstream EDE Entity means a QHP Issuer EDE Entity that uses the
EDE Environment of a Primary EDE Entity and adds functionality or systems to the
Primary EDE Entity’s EDE Environment such that the Primary EDE Entity’s EDE
Environment or overall EDE End-User Experience is modified beyond minor
deviations for branding or QHP display changes relevant to the Issuer’s QHPs.
(46) Hybrid Non-Issuer Upstream EDE Entity means an Agent, Broker, or Web-broker
under 45 C.F.R. §§ 155.220(c)(3) and 155.221 that uses the EDE Environment of a
Primary EDE Entity and adds functionality or systems to the Primary EDE Entity’s
EDE Environment such that the Primary EDE Entity’s EDE Environment or overall
EDE End-User Experience is modified beyond minor branding changes.
(47) Incident, or Security Incident, has the meaning contained in OMB Memoranda
M-17-12 (January 3, 2017) and means an occurrence that: (1) actually or imminently
jeopardizes, without lawful authority, the integrity, confidentiality, or availability of
information or an information system; or (2) constitutes a violation or imminent threat
of violation of law, security policies, security procedures, or acceptable use policies.
(48) Insurance Affordability Program means a program that is one of the following:
(1) A State Medicaid program under title XIX of the Social Security Act.
(2) A State Children’s Health Insurance Program (CHIP) under title XXI of the
Social Security Act.
(3) A State basic health program established under section 1331 of the Care Act.

39

(4) A program that makes coverage in a Qualified Health Plan (QHP) through the
Exchange with APTC established under section 36B of the Internal Revenue
Code available to Qualified Individuals.
(5) A program that makes available coverage in a QHP through the Exchange
with CSRs established under section 1402 of the ACA.
(49) Interconnection Security Agreement means a distinct agreement that outlines the
technical solution and security requirements for an interconnection between CMS and
EDE Entity.
(50) Issuer has the meaning set forth in 45 C.F.R. § 144.103.
(51) Non-Exchange Entity has the meaning at 45 C.F.R. § 155.260(b)(1), including, but
not limited to, Qualified Health Plan (QHP) Issuers, Navigators, Agents, Brokers, and
Web-brokers.
(52) OMB means the Office of Management and Budget.
(53) Operational Readiness Review (ORR) means an audit conducted under 45 C.F.R.
§§ 155.221(b)(4) and (f) and includes the reports submitted by an EDE Entity
detailing its compliance with CMS requirements and readiness to implement and use
the EDE Environment.
(54) Personally Identifiable Information (PII) has the meaning contained in OMB
Memoranda M-17-12 (January 3, 2017), and means information that can be used to
distinguish or trace an individual's identity, either alone or when combined with other
information that is linked or linkable to a specific individual.
(55) Primary EDE Entity means an entity that has developed and maintains an EDE
Environment. A Primary EDE Entity may provide its EDE Environment to an
Upstream EDE Entity and the Primary EDE Entity may provide an EDE Environment
for use by Consumers, Applicants, Qualified Individuals, Enrollees—or these
individuals’ legal representatives or Authorized Representatives—, Agents, Brokers,
or DE Entity Application Assisters.
(56) Prospective EDE Entity means an entity that has not yet been approved by CMS to
use the EDE Pathway.
(57) Prospective Phase Change EDE Entity means a Primary EDE Entity already
approved to use the EDE Pathway that is seeking to implement a new eligibility
application phase using the EDE Entity-initiated Change Request process.
(58) Qualified Health Plan (QHP) has the meaning set forth in 45 C.F.R. § 155.20.
(59) Qualified Health Plan (QHP) Issuer has the meaning set forth in
45 C.F.R. § 155.20.
(60) Qualified Health Plan (QHP) Issuer Agreement means the QHP Certification
Agreement and Privacy and Security Agreement Between QHP Issuer and CMS.
40

(61) Qualified Health Plan (QHP) Direct Enrollment (DE) Technology Provider has
the meaning set forth in 45 C.F.R. § 155.20.
(62) Qualified Individual has the meaning set forth in 45 C.F.R. § 155.20.
(63) Rules of Engagement (ROE) means the detailed guidelines and constraints
regarding the execution of information security testing. The ROE is established
before the start of a security test and gives the test team authority to conduct defined
activities without the need for additional permissions.
(64) Special Enrollment Period (SEP) has the meaning set forth in 45 C.F.R. § 155.20.
(65) Standalone Eligibility Service (SES) means a suite of application program interfaces
(APIs) that will allow an EDE Entity to create, update, submit, and ultimately retrieve
eligibility results for an application.
(66) State means the State that has licensed the Agent, Broker, Web-broker, or Issuer that
is a party to this Agreement and in which the Agent, Broker, Web-broker, or Issuer is
operating.
(67) State-based Exchange (SBE) means an Exchange established by a State that
receives approval to operate under 45 C.F.R. § 155.105. State-based Marketplace
(“SBM”) has the same meaning as SBE.
(68) State-based Exchange on the Federal Platform (SBE-FP) means an Exchange
established by a State that receives approval under 45 C.F.R. § 155.106(c) to utilize
the Federal platform to support select eligibility and enrollment functions. Statebased Marketplace on the Federal Platform (“SBM-FP”) has the same meaning as
SBE-FP.
(69) Streamlined Eligibility Application User Interface (UI) means the application UI
on HealthCare.gov available for Consumers, Applicants, Qualified Individuals, and
Enrollees—or these individuals’ legal representatives or Authorized
Representatives—with non-complex eligibility application responses determined by
an initial set of eligibility questions for determining the complexity of an Applicant’s
eligibility profile.
(70) Upstream EDE Entity means an EDE Entity that uses the EDE Environment of a
Primary EDE Entity and meets the definition of a Hybrid Issuer Upstream EDE
Entity; a Hybrid Non-Issuer Upstream EDE Entity; or a White-Label Issuer Upstream
EDE Entity.
(71) Web-broker has the meaning set forth in 45 C.F.R. § 155.20.
(72) Web-broker Agreement means the Agreement between a Web-broker and CMS for
the FFEs and SBE-FPs.
(73) White-Label Issuer Upstream EDE Entity means a QHP Issuer that uses the EDE
Environment of a Primary EDE Entity without modifications beyond minor branding
changes or QHP display changes.
41

(74) Workforce means a Non-Exchange Entity’s employees, contractors, subcontractors,
officers, directors, agents, representatives, and any other individual who may create,
collect, disclose, access, maintain, store, or use PII in the performance of his or her
duties.

42

43

APPENDIX C: EDE BUSINESS REQUIREMENTS 33
32F

All capitalized terms used herein carry the meanings assigned in Appendix B: Definitions. Any
capitalized term that is not defined in the Agreement, this Appendix or in Appendix B:
Definitions has the meaning provided in 45 C.F.R. § 155.20.
Review Category
Consumer
Identity Proofing
Implementation

Requirement and Audit Standard


Requirement: The EDE Entity must conduct identity proofing (ID proofing) for Consumers entering
the EDE pathway for enrollments through both Consumer and in-person Agent and Broker
pathways. 34 The EDE Entity must conduct ID proofing prior to submitting a Consumer’s
application to the Exchange. If an EDE Entity is unable to complete ID proofing of the Consumer,
the EDE Entity may either direct the Consumer to the classic DE (i.e., double-redirect) pathway or
direct the Consumer to the Exchange (HealthCare.gov or the Exchange Call Center at 1-800-3182596 [TTY: 1-855-889-4325]).
– Remote ID Proofing/Fraud Solutions Archive Reporting Services (RIDP/FARS) or ThirdParty ID Proofing Service: CMS will make the Exchange RIDP and FARS services
available for the EDE Entity to use when remote ID proofing Consumers for the
Consumer pathway (i.e., when a Consumer is interacting directly with the EDE
environment without the assistance of an individual Agent or Broker). If an EDE Entity
uses the Exchange RIDP service, it must use the RIDP service only after confirming the
Consumer is seeking coverage in a State supported by the Exchange/Federal Platform,
and only after confirming the Consumer is eligible for the EDE Entity’s chosen phase.
However, CMS does not require that EDE Entities use the Exchange RIDP and FARS
services, specifically, to complete ID proofing. An EDE Entity may instead opt to use a
third-party ID proofing service for ID proofing in the Consumer pathway. If an EDE Entity
uses a third-party identity proofing service, the service must be Federal Identity,
Credential, and Access Management (FICAM) Trust Framework Solutions (TFS)approved, and the EDE Entity must be able to produce documentary evidence that each
Applicant has been successfully ID proofed. Documentation related to a third-party
service could be requested in an audit or investigation by CMS (or its designee), pursuant
to the EDE Business Agreement. Applicants do not need to be ID proofed on subsequent
interactions with the EDE Entity if the Applicant creates an account (i.e., username and
password) on the EDE Entity’s website, and the EDE Entity tracks that ID proofing has
occurred when the Applicant’s account was created.
– Manual ID Proofing in the In-Person Agent and Broker Pathway: EDE Entities may also
offer a manual ID proofing process. Consumers being ID proofed in the in-person Agent
and Broker pathway (i.e., when an Agent or Broker is working with a Consumer and
conducting ID proofing in-person, rather than remotely) must be ID proofed following the
guidelines outlined in the document “Acceptable Documentation for Identity Proofing”
available on CMS zONE (https://zone.cms.gov/document/api-information).
33F

33
The table in Appendix C is an updated version of Exhibit 2 in the “Third-party Auditor Operational Readiness
Reviews for the Enhanced Direct Enrollment Pathway and Related Oversight Requirements.”
34
Consumer pathway means the workflow, UI, and accompanying APIs for an EDE environment that is intended for
use by a Consumer to complete an eligibility application and enrollment. Agent and Broker pathway means the
workflow, UI, and accompanying APIs for an EDE environment that is intended for use by an Agent or Broker to
assist a Consumer with completing an eligibility application and enrollment.

44

Review Category

Requirement and Audit Standard
For the Consumer pathway, the EDE Entity must provide the User ID of the requester in
the header for each EDE API call. For the Consumer pathway, the User ID should be the
User ID for the Consumer’s account on the EDE Entity’s site, or some other distinct
identifier the EDE Entity assigns to the Consumer.
– Additionally, if an EDE Entity is using the Fetch Eligibility API, the same User ID
requirements apply. However, instead of sending the User ID via the header, the User ID
will be provided in the request body via the following path:
ExchangeUser/ExchangeUserIdentification/IdentificationID.
Review Standard:
– If an EDE Entity uses the Exchange RIDP service, the Auditor must verify that the EDE
Entity has successfully passed testing with the Hub. 35
– If an EDE Entity uses a third-party ID proofing service, the Auditor must evaluate and
certify the following:
The ID proofing service is FICAM TFS-approved, and
The EDE Entity has implemented the service correctly.
– If an EDE Entity offers a Manual ID proofing option for an in-person Agent and Broker
pathway, the Auditor must verify that the EDE Entity requires Agents and Brokers to ID
proof Consumers as described in the “Acceptable Documentation for Identity Proofing”
document.
– EDE Entity’s inclusion of the appropriate Consumer User ID fields in the EDE and Fetch
Eligibility API calls.
–

Consumer
Identity Proofing
Implementation
(continued)



34F

RIDP/FARS testing requirements for the Hub can be found at the following link on CMS zONE:
https://zone.cms.gov/document/api-information.
35

45

Review Category
Agent and Broker
Identity Proofing
Verification

Requirement and Audit Standard


Requirement: If an EDE Entity is implementing an Agent and Broker pathway for its EDE
environment, the EDE Entity must implement Agent and Broker ID proofing verification procedures
that consist of the following requirements:
– EDE Entity must integrate with IDM-Okta 36 and provide the User ID of the requester and
IDM-Okta token in the header for each EDE API call. For Agents and Brokers, the User
ID must exactly match the Exchange User ID (i.e. the Agent’s or Broker’s portal.cms.gov
User ID) for the Agent or Broker, or the request will fail Exchange User ID validation.
The same User ID requirements apply to the Fetch Eligibility and Submit
Enrollment APIs. However, instead of sending the User ID via the header, the
User ID will be provided in the request body via the following path:
ExchangeUser/ExchangeUserIdentification/IdentificationID.
– EDE Entity must ID proof all Agents and Brokers prior to allowing the Agents and Brokers
to use its EDE environment. EDE Entity may conduct ID proofing in one of the following
ways:
Use the Exchange-provided RIDP/FARS APIs to remotely ID proof Agents and
Brokers; OR
Manually ID proof Agents and Brokers following the guidelines outlined in the
document “Acceptable Documentation for Identity Proofing” available on CMS
zONE EDE webpage (https://zone.cms.gov/document/api-information).
EDE Entities are permitted to use manual ID proofing as an alternative for
Agents and Brokers that cannot be ID proofed via the RIDP/FARS services.
– EDE Entity must validate an Agent’s or Broker’s National Producer Number (NPN) using
the National Insurance Producer Registry (https://www.nipr.com) prior to allowing the
Agent or Broker to use its EDE environment.
– EDE Entity must systematically provide an Agent and Broker ID proofing process—that
meets all of the requirements defined here—that applies to all downstream Agents and
Brokers of the Primary EDE Entity.
– Additionally, all Agent and Broker users of an Upstream EDE Entity’s EDE website
(hosted by a Primary EDE Entity) must be ID proofed consistent with these requirements.
The Primary EDE Entity may provide one centralized ID proofing approach for any Agents
and Brokers that will use the Primary EDE Entity’s EDE environment (including when
utilized by Upstream EDE Entities and their downstream Agents and Brokers).
35F

For instructions on how to integrate with IDM-Okta, see the Change Request #55 Integration Manual (IDM
Integration), available at: https://zone.cms.gov/document/business-audit and Hub Onboarding Form, available at:
https://zone.cms.gov/document/hub-onboarding-form.
36

46

Review Category

Requirement and Audit Standard

Agent and Broker
Identity Proofing
Verification
(continued)



Phase-dependent
Screener
Questions (EDE
Phase 1 and 2
EDE Entities
Only)





Alternatively, the Upstream EDE Entity may conduct its own ID proofing
process of its downstream Agents and Brokers consistent with these
requirements. The Upstream EDE Entity must provide the information for
Agents and Brokers that have passed and failed ID proofing to the Primary
EDE Entity using a secure data transfer. If an Upstream EDE Entity wants to
pursue this flexibility, its ID proofing process must be audited by an Auditor
consistent with these standards and the arrangement will be considered a
hybrid arrangement.
– Note: If a Primary EDE Entity does not provide a centralized process for ID proofing an
Upstream EDE Entity’s downstream Agent and Broker and if the Primary EDE Entity
intends to provide the EDE environment to Upstream EDE Entities, the Upstream EDE
Entities will be required to provide documentation of an Auditor’s evaluation of its ID
proofing approach consistent with these standards. This process must be categorized as
an EDE Entity-initiated Change Request (Section XI.A, EDE Entity-initiated Change
Requests) if it occurs after the Primary EDE Entity’s initial audit submission and the
arrangement with the Upstream EDE Entity will be considered a hybrid arrangement.
– All Agents and Brokers that will use EDE must be ID proofed consistent with these
standards. This includes downstream Agents and Brokers of Primary EDE Entities and
Upstream EDE Entities. If applicable, the Auditor must evaluate the Primary EDE Entity’s
centralized implementation for ID proofing or the Upstream EDE Entity’s implementation
for ID proofing.
– EDE Entity is strongly encouraged to implement multi-factor authentication for Agents and
Brokers that is consistent with NIST SP 800-63-3.
Review Standard: The Auditor must verify and certify the following:
– EDE Entity’s inclusion of the appropriate Agent and Broker User ID and IDM-Okta token
fields in the EDE and Fetch Eligibility and Submit Enrollment API calls.
– EDE Entity’s process for ID proofing an Agent or Broker prior to allowing an Agent or
Broker to use its EDE environment.
– EDE Entity’s process for validating an Agent’s or Broker’s NPN using the National
Insurance Producer Registry prior to allowing an Agent or Broker to use its EDE
environment.
– EDE Entity’s process for systematically providing an Agent and Broker ID proofing
approach for all downstream Agents and Brokers of the EDE Entity and, if applicable, any
Upstream EDE Entities.
– If the Primary EDE Entity has not provided a centralized ID proofing approach to an
Upstream EDE Entity, Primary EDE Entity’s process for verifying that an Upstream EDE
Entity has conducted appropriate ID proofing, consistent with this requirement, for all of
the Upstream EDE Entity’s downstream Agents and Brokers prior to those Agents and
Brokers being able to use the Primary EDE Entity’s EDE environment.
Requirement: An EDE Entity that implements either EDE Phase 1 or Phase 2 must implement
screening questions to identify Consumers whose eligibility circumstances the EDE Entity is
unable to support consistent with the eligibility scenarios supported by the EDE Entity’s selected
EDE phase. These phase-dependent screener questions must be located at the beginning of the
EDE application, but may follow the QHP plan compare experience. For those Consumers who
won’t be able to apply through scenarios covered by the EDE phase that the EDE Entity
implements, the EDE Entity must either route the Consumer to the classic DE double-redirect
pathway or direct the Consumer to the Exchange by providing the following options:
HealthCare.gov or the Exchange Call Center at 1-800-318-2596 [TTY: 1-855-889-4325].
Review Standard: The Auditor must verify the following:
– The EDE Entity has implemented screening questions—consistent with the requirements
in the Exchange Application UI Principles document and Application UI Toolkit—to
identify Consumers with eligibility scenarios not supported by the EDE Entity’s EDE
environment and selected EDE phase.
– The EDE Entity’s EDE environment facilitates moving Consumers to one of the
alternative enrollment pathways described immediately above.

47

Review Category

Requirement and Audit Standard

Accurate and
Streamlined
Eligibility
Application User
Interface (UI)



Requirement: EDE Entities using the EDE pathway must support all application scenarios outlined
in EDE Entity’s selected EDE phase. The EDE Entity must adhere to the guidelines set forth in the
FFE Application UI Principles document when implementing the application. EDE Entities can
access the FFE Application UI Principles document on CMS zONE
(https://zone.cms.gov/document/eligibility-information). Auditors will need to access the FFE
Application UI Principles document to conduct the audit.
– As explained in the FFE Application UI Principles document, the EDE Entity must
implement the application in accordance with the Exchange requirements. For each
supported eligibility scenario, the EDE Entity must display all appropriate eligibility
questions and answers, including all questions designated as optional. (Note: These
questions are optional for the Consumer to answer, but are not optional for EDE Entities
to implement.) The FFE Application UI Principles document and Application UI Toolkit
define appropriate flexibility EDE Entities may implement with respect to question
wording, question order or structure, format of answer choices (e.g., drop-down lists,
radio buttons), and integrated help information (e.g., tool tips, URLs, help boxes). In most
cases, answer choices, question logic (e.g., connections between related questions), and
disclaimers (e.g., APTC attestation) must be identical to those of the Exchange.
Note: The phrase “supported eligibility scenario” does not refer to the Eligibility
Results Toolkit scenarios. Auditors must verify that EDE Entities can support all
scenarios supported by the EDE Entity’s selected phase and this exceeds the
scope of the test cases in the Eligibility Results Toolkits.
– EDE Entities will also need to plan their application’s back-end data structure to ensure
that attestations can be successfully submitted to Standalone Eligibility Service (SES)
APIs at appropriate intervals within the application process and that the EDE Entity can
process responses from SES and integrate them into the UI question flow logic, which is
dynamic for an individual Consumer based on his or her responses. The EDE Entity will
need to ensure that sufficient, non-contradictory information is collected and stored such
that accurate eligibility results will be reached without any validation errors.
Review Standard: The Auditor must review and certify the following:
– The FFE Application UI has been implemented in EDE Entity’s environment in
accordance with the Exchange Application UI Principles document.
– The FFE Application UI displays all appropriate eligibility questions and answers from the
Application UI Toolkit, including any questions designated as optional.
– The Auditor will review the application for each supported eligibility scenario under the
phase the EDE Entity has implemented to confirm that the application has been
implemented in accordance with the FFE Application UI Principles document and
Application UI Toolkit. The Auditor will document this compliance in the Application UI
Toolkit.
Note: The phrase “supported eligibility scenario” does not refer to the Eligibility
Results Toolkit scenarios. Auditors must verify that EDE Entities can support all
scenarios supported by the EDE Entity’s selected phase and this exceeds the
scope of the test cases in the Eligibility Results Toolkits.
– If EDE Entity has implemented Phase 1 or Phase 2, the Auditor will confirm that the UI
includes a disclaimer stating that the environment does not support all application
scenarios, and identifying which scenarios are and are not supported. The disclaimer
should direct the Consumer to alternative pathways, such as the classic DE doubleredirect pathway or direct the Consumer to the Exchange (HealthCare.gov or the
Exchange Call Center at 1-800-318-2596 (TTY: 1-855-889-4325)). This requirement is
included in the Communications Toolkit.

48

Review Category
Post-eligibility
Application
Communications

Requirement and Audit Standard


Requirement: The EDE environment must display high-level eligibility results, next steps for
enrollment, and information about each Applicant’s insurance affordability program eligibility (e.g.,
APTC, CSR, Medicaid, and/or CHIP eligibility), Data Matching Issues (DMIs), special enrollment
periods (SEPs), SEP Verification Issues (SVIs), and enrollment steps in a clear, comprehensive
and Consumer-friendly way. Generally, CMS’s Communications Toolkit constitutes the minimum
post-eligibility application communications requirements that an EDE Entity must provide to users
of the EDE environment; CMS does not intend for the Communications Toolkit requirements to
imply that EDE Entities are prohibited from providing additional communications or functionality,
consistent with applicable requirements.
– EDE Entity must provide Consumers with required UI messaging tied to API functionality
and responses as provided in the EDE API Companion Guide 37.
– EDE Entity must provide Consumers with the CMS-provided Eligibility Determination
Notices (EDNs) generated by the Exchange any time it submits or updates an application
pursuant to requirements provided by CMS in the Communications Toolkit.
36F

The API Companion Guide is available on CMS zONE at the following link: https://zone.cms.gov/document/apiinformation.
37

49

Review Category

Requirement and Audit Standard
EDE Entity must provide the EDN in a downloadable format at the time the Consumer’s
application is submitted or updated and must have a process for providing access to the
Consumer’s most recent EDN via the API as well as providing access to the Consumer’s
historical notices—accessed via the Notice Retrieval API by the EDE Entity’s EDE
environment—within the UI. The UI requirements related to accessibility of a Consumer’s
EDN are set forth in the Communications Toolkit.
– EDE Entities are not required to store notices downloaded from the Exchange. EDE
Entities must use the Metadata Search API and the Notice Retrieval API to generate the
most recent Exchange notices when Consumers act to view/download notices consistent
with the Communications Toolkit. EDE Entities must also provide access to
view/download historical notices in their UIs.
– EDE Entity must provide and communicate status updates and access to information for
Consumers to manage their applications and coverage. These communications include,
but are not limited to, status of DMIs and SVIs, enrollment periods (e.g., SEP eligibility
and the OEP), providing and communicating about new notices generated by the
Exchange, application and enrollment status, and supporting document upload for DMIs
and SVIs. This requirement is detailed in the Communications Toolkit.
– EDE Entity must provide application and enrollment management functions for the
Consumer in a clear, accessible location in the UI (e.g., an account management hub for
managing all application- and enrollment-related actions).
– For any Consumers enrolled, including via the Agent and Broker pathway, the EDE Entity
must provide critical communications to Consumers notifying them of the availability of
Exchange-generated EDNs, critical communications that the Consumer will no longer
receive from the Exchange (i.e., if the EDE Entity has implemented and been approved
by CMS to assume responsibility for those communications), and any other critical
communications that an EDE Entity is providing to the Consumer in relation to the
Consumer’s application or enrollment status.
– All EDE Entities, regardless of phase, must provide Consumers with status updates and
document upload capabilities for all DMIs and SVIs. Even if an EDE Entity’s chosen
eligibility application phase does not support the questions necessary to reach a certain
DMI or SVI, the post-application and post-enrollment functionality must support any
Consumer with any DMI or SVI; post-application and post-enrollment DMI and SVI
management is not dependent on the EDE Entity’s chosen eligibility application phase.
Review Standard: The Auditor must verify and certify the following:
– The EDE Entity’s EDE environment is compliant with the requirements contained in the
Communications Toolkit and API Companion Guide.
– The EDE Entity’s EDE environment notifies Consumers of their eligibility results prior to
QHP enrollment, including when submitting a CiC in the environment. For example, if a
Consumer’s APTC or CSR eligibility changes, EDE Entity must notify the Consumer of
the change and allow the Consumer to modify his or her QHP selection (if SEP-eligible)
or APTC allocation accordingly.
– EDE Entity must have a process for providing Consumers with a downloadable EDN in its
EDE environment and for providing access to a current EDN via the API. EDE Entity must
share required eligibility information that is specified by CMS in the Communications
Toolkit.
– The Auditor must verify that EDE Entity’s EDE environment is providing status updates
and ongoing communications to Consumers according to CMS requirements in the
Communications Toolkit as it relates to the status of their application, eligibility,
enrollment, notices, and action items the Consumer needs to take.
– The EDE Entity must provide application and enrollment management functions for the
Consumer in a clear, accessible location in the UI.
– The EDE Entity must have a means for providing critical communications to the
Consumer consistent with the standards above.
– The EDE Entity must support all DMIs and SVIs in its post-eligibility application and postenrollment functionality.
–

Post-eligibility
Application
Communications
(continued)



50

Review Category

Requirement and Audit Standard

Accurate
Information
about the
Exchange and
Consumer
Communications



Documentation
of Interactions
with Consumer
Applications or
the Exchange





Requirement: EDE Entity must provide Consumers with CMS-provided language informing and
educating the Consumers about the Exchanges and HealthCare.gov and Exchange-branded
communications Consumers may receive with important action items. CMS defines these
requirements in the Communications Toolkit.
Review Standard: The Auditor must verify and certify that the EDE Entity’s EDE environment
includes all required language, content, and disclaimers provided by CMS in accordance with the
standards stated in guidance and the Communications Toolkit.
Requirement: EDE Entity must implement and maintain tracking functionality on its EDE
environment to track Agent, Broker, and Consumer interactions, as applicable, with Consumer
applications using a unique identifier for each individual, as well as an individual’s interactions with
the Exchanges (e.g., application; enrollment; and handling of action items, such as uploading
documents to resolve a DMI). This requirement also applies to any actions taken by a downstream
Agent or Broker, 38 as well as the Upstream EDE Entity users, of a Primary EDE Entity’s EDE
environment.
Review Standard: The Auditor must verify EDE Entity’s process for determining and tracking when
an Upstream EDE Entity, downstream Agent or Broker, and Consumer has interacted with a
Consumer application or taken actions utilizing the EDE environment or EDE APIs. The Auditor
must verify and certify the following:
– The EDE Entity’s environment tracks, at a minimum, the interactions of Upstream EDE
Entities, downstream Agents or Brokers, and Consumers with a Consumer’s account,
records, application, or enrollment information utilizing the EDE environment or EDE
APIs.
– The EDE Entity’s environment tracks when an upstream Entity, downstream Agent or
Broker, or Consumer views a Consumer’s record, enrollment information, or application
information utilizing the EDE environment or EDE APIs.
– The EDE Entity’s environment uses unique identifiers to track and document activities by
Consumers, downstream Agents and Brokers, and Upstream EDE Entities using the EDE
environment.
– The EDE Entity’s environment tracks interactions with the EDE suite of APIs by an
Upstream EDE Entity, a downstream Agent or Broker, or Consumer.
– The EDE Entity’s environment stores this information for 10 years.
37F



Note: References to downstream Agents and Brokers include downstream Agents and Brokers of either the
Primary EDE Entity or an Upstream EDE Entity.
38

51

Review Category
Eligibility Results
Testing and SES
Testing

Requirement and Audit Standard




API Functional
Integration
Requirements





Application UI
Validation




Requirement: EDE Entity must submit accurate applications through its EDE environment that
result in accurate and consistent eligibility determinations for the supported eligibility scenarios
covered by EDE Entity’s chosen EDE phase.
– The business requirements audit package must include testing results in the designated
Exchange EDE testing environment. CMS has provided a set of Eligibility Results Toolkits
with the eligibility testing scenarios on CMS zONE
https://zone.cms.gov/document/business-audit).
Review Standard: The Auditor must verify and certify the following:
– The Auditor was able to successfully complete a series of test eligibility scenarios in the
EDE Entity’s EDE environment implementation using the Eligibility Results Toolkits. For
example, these scenarios may include Medicaid and CHIP eligibility determinations, and
different combinations of eligibility determinations for APTC and CSRs. Note: These
scenarios do not test, and are not expected to test, every possible question in the
Application UI flow for an EDE Entity’s selected phase. In addition to reviewing the
eligibility results test cases, the Auditor must review the Application UI for compliance as
defined above.
– The Auditor must test each scenario and verify that the eligibility results and the eligibility
process were identical to the expected results and process. The Auditor must provide
CMS confirmation that each relevant eligibility testing scenario was successful, that the
expected results were received, and must submit the required proof, as defined in the
Eligibility Results Toolkits. This will include screenshots, EDNs, and the raw JSON from
the Get App API response for the application version used to complete the scenario.
Note: EDNs and raw JSONs are required for all required toolkit scenarios; however,
screenshots are only required for the highest phase an entity is submitting (for example, a
Prospective phase 3 EDE Entity must submit screenshots for the Phase 3 Eligibility
Results Toolkit only, but must submit EDNs and raw JSONs for applicable Phase 1,
Phase 2, and Phase 3 toolkit scenarios).
Requirement: EDE Entity must implement the EDE API suite and corresponding UI functionality in
accordance with the API specifications and EDE API Companion Guide provided by CMS. The
EDE API specifications and EDE API Companion Guide are available on CMS zONE
(https://zone.cms.gov/document/api-information).
Review Standard: The Auditor must complete the set of test scenarios as outlined in the API
Functional Integration Toolkit to confirm that the EDE Entity’s API and corresponding UI
integration performs the appropriate functions when completing the various EDE tasks. For
example, the Auditor may have to complete a scenario to verify that a Consumer or Agent and
Broker is able to view any SVIs or DMIs that may exist for a Consumer, and confirm that the
Consumer or Agent and Broker has the ability to upload documents to resolve any SVIs or DMIs.
Some of the test cases require that the Auditor and EDE Entity request CMS to process
adjudication actions; the Auditor cannot mark these particular test cases as compliant until
evaluating whether the expected outcome occurred after CMS takes the requested action. The
Auditor will also need to be aware of the following requirements related to the test scenarios:
– Test scenarios in the API Functionality Integration Toolkit must be completed for both the
Consumer pathway and the Agent and Broker pathway if an EDE Entity is pursuing
approval to use both pathways.
– The API Functional Integration Toolkit includes a “Required Evidence” column, Column H,
on the “Test Cases” tab. Auditors will need to submit the applicable “Required Evidence,”
including the complete header and body for each required API request and response, as
part of the audit submission.
Requirement: EDE Entity must implement CMS-defined validation requirements within the
application. The validation requirements prevent EDE Entity from submitting incorrect data to the
Exchange.
Review Standard: The Auditor must confirm that EDE Entity has implemented the appropriate
application field-level validation requirements consistent with CMS requirements. These field-level
validation requirements are documented in the FFE Application UI Principles document.

52

Review Category
Section 508compliant UI

Requirement and Audit Standard




Non-Englishlanguage Version
of the Application
UI and Communication Materials



Requirement: Pursuant to 45 C.F.R. § 155.220(c)(3)(ii)(D) (citing 45 C.F.R. §§ 155.230 and
155.260(b)) and 45 C.F.R. § 156.265(b)(3)(iii) (citing 45 C.F.R. §§ 155.230 and 155.260(b)), Webbrokers and QHP Issuers participating in DE, including all EDE Entities, must implement an
eligibility application UI that is Section 508 compliant. A Section 508-compliant application must
meet the requirements set forth under Section 508 of the Rehabilitation Act of 1973, as amended
(29 U.S.C. § 794(d)).
Review Standard: The Auditor must confirm that EDE Entity’s application UI meets the
requirements set forth under Section 508 of the Rehabilitation Act of 1973, as amended (29 U.S.C.
§ 794(d)). The Auditor must verify and certify the following:
– Within the Business Requirements Audit Report Template, the Auditor must confirm that
the EDE Entity’s application UI is Section 508 compliant. No specific report or
supplemental documentation is required.
– The Auditor may review results produced by a 508 compliance testing tool. If an EDE
Entity uses a 508 compliance testing tool to verify that its application UI is 508 compliant,
its Auditor must, at a minimum, review the results produced by the testing tool and
document any non-compliance, as well as any mitigation or remediation to address the
non-compliance. It is not sufficient for an Auditor to state that an EDE Entity complies with
this requirement by confirming that the EDE Entity utilized a 508 compliance testing tool.
Requirement: In accordance with 45 C.F.R. § 155.205(c)(2)(iv)(B) and (C), QHP Issuers and Webbrokers, including those that are EDE Entities, must translate applicable website content (e.g., the
application UI) on Consumer-facing websites into any non-English language that is spoken by a
limited English proficient (LEP) population that reaches ten (10) percent or more of the population
of the relevant State, as determined in current guidance published by the Secretary of HHS. 39
EDE Entities must also translate communications informing Consumers of the availability of
Exchange-generated EDNs; critical communications that the Consumer will no longer receive from
the Exchange (i.e., if the EDE Entity has implemented and been approved by CMS to assume
responsibility for those communications); and any other critical communications that an EDE Entity
is providing to the Consumer in relation to the Consumer’s use of its EDE environment into any
non-English language that is spoken by an LEP population that reaches ten (10) percent or more
of the population of the relevant State, as determined in guidance published by the Secretary of
HHS. 40
Review Standard: The Auditor must verify and certify the following:
– The Auditor must confirm that the non-English-language version of the application UI and
associated critical communications are compliant with the Exchange requirements,
including the Application UI Toolkit and Communications Toolkit.
– The Auditor must verify that the application UI has the same meaning as its Englishlanguage version.
– The Auditor must also verify that EDE Entity has met all EDE communications translation
requirements released by CMS in the Communications Toolkit.
– The Auditor must document compliance with this requirement within the Business
Requirements Audit Report Template, the Application UI Toolkit, and the
Communications Toolkit. In the toolkits, the Auditor can add additional columns for the
Auditor compliance findings fields (yellow-shaded columns) or complete the Spanish audit
in a second copy of each of the two toolkits.
38F



39F

Guidance and Population Data for Exchanges, Qualified Health Plan Issuers, and Web-Brokers to Ensure
Meaningful Access by Limited-English Proficient Speakers Under 45 CFR §155.205(c) and §156.250 (March 30,
2016) https://www.cms.gov/CCIIO/Resources/Regulations-and-Guidance/Downloads/Language-accessguidance.pdf and “Appendix A- Top 15 Non-English Languages by State”
https://www.cms.gov/CCIIO/Resources/Regulations-and-Guidance/Downloads/Appendix-A-Top-15-non-englishby-state-MM-508_update12-20-16.pdf.
40
Frequently Asked Questions (FAQs) Regarding Spanish Translation and Audit Requirements for Enhanced Direct
Enrollment (EDE) Entities Serving Consumers in States with Federally-facilitated Exchanges (FFEs) (June 20,
2018) provides further information regarding translation and audit requirements:
https://www.cms.gov/CCIIO/Programs-and-Initiatives/Health-Insurance-Marketplaces/Downloads/FAQ-EDESpanish-Translation-and-Audit-Requirements.PDF.
39

53

Review Category
EDE Change
Management
Process

Requirement and Audit Standard



Health
Reimbursement
Arrangement
(HRA) Offer
Required UI
Messaging





Requirement: EDE Entity must develop and consistently implement processes for managing
changes to the EDE environment relevant to the business requirements audit requirements. This
requirement does not replace the evaluation necessary for relevant privacy and security controls.
At a minimum, the EDE Entity’s change management plan must include the following elements:
– A process that incorporates all elements of the Change Notification SOP as referenced in
Section XI.A.i, EDE Entity-initiated Change Request Process;
– All application and business audit-related changes are thoroughly defined and evaluated
prior to implementation, including the potential effect on other aspects of the EDE enduser experience;
– A process for defining regression testing scope and developing or identifying applicable
testing scenarios;
– A process for conducting regression testing;
– A process for identifying and correcting errors discovered through regression testing and
re-testing the correction;
– A process for maintaining separate testing environments and defining the purposes and
releases for each environment;
– The change management process must be maintained in writing and relevant individuals
must be informed on the change management process and on any updates to the
process; and
– The change management process must include a process, if applicable, for an EDE
Entity to update the non-English-language version of the application UI and
communication materials for any changes to the application UI or communication
materials in the English-language version of the EDE environment.
Review Standard: The Auditor must evaluate the EDE Entity’s change management plan for
compliance with the elements and criteria defined above.
Requirement: Phase 3 EDE Entities, Phase 2 EDE Entities that optionally implement full HRA
functionality, and EDE Entities that also offer a classic DE pathway, must implement required UI
messaging for qualified individuals who have an HRA offer that is tailored to the type and
affordability of the HRA offered to the qualified individuals consistent with CMS guidance.
Required UI messaging for various scenarios are detailed in the FFEs DE API for Webbrokers/Issuers Technical Specifications document. 41
Review Standard: The Auditor must review the EDE Entity’s HRA offer implementation to confirm
that the required UI messaging content is displayed for each of the relevant scenarios detailed in
the FFEs DE API for Web-brokers/Issuers Technical Specifications document.
40F

41

The document FFEs DE API for Web-brokers/Issuers Technical Specifications (Direct Enrollment API Specs) is
available on CMS zONE at the following link: https://zone.cms.gov/document/direct-enrollment-de-documents-andmaterials.
54

APPENDIX D: REQUIRED DOCUMENTATION
The below table describes the required artifacts that the EDE Entity must complete for approval
during Year 6 of EDE. 42 Additional details about the documentation related to the privacy and
security audit (i.e., Interconnection Security Agreement (ISA), Security Privacy Assessment
Report, Plan of Actions & Milestones (POA&M), Privacy Impact Assessment, Non-Exchange
Entity System Security and Privacy Plan (NEE SSP), Incident Response Plan and
Incident/Breach Notification Plan, Contingency Plan, Configuration Management Plan, and
Information Security and Privacy Continuous Monitoring Strategy Guide (ISCM Guide) 43 are
provided in related CMS guidance. All capitalized terms used herein carry the meanings assigned
in Appendix B: Definitions. Any capitalized term that is not defined in the Agreement, this
Appendix or in Appendix B: Definitions has the meaning provided in 45 C.F.R. § 155.20.
41F

42F

“Year 6 of EDE” refers to the remainder of PY 2023 and PY 2024, including the PY 2024 OEP. The table in
Appendix D is an updated combined version of Exhibits 4 and 7 in the “Third-party Auditor Operational Readiness
Reviews for the Enhanced Direct Enrollment Pathway and Related Oversight Requirements.”
43
These documents are available on CMS zONE at the following link: https://zone.cms.gov/document/enhanceddirect-enrollment.
42

55

Document

Description

Submission
Requirements

56

Entity
Responsible

Deadline

Notice of Intent to
Participate and
Auditor
Confirmation



Once the Prospective
Primary and
Prospective Phase
Change EDE Entity
has a confirmed
Auditor(s) who will be
completing its audit(s),
it must notify CMS that
it intends to apply to
use the EDE pathway
for Year 6 of EDE prior
to initiating the audit.
The email must
include the following:
– Prospective
EDE Entity
Name
– Auditor
Name(s) and
Contact
Information
(Business
Requirements
and Privacy
and Security,
if different)
– A copy of the
executed
contract with
the Auditor(s)
(pricing and
proprietary
information
may be
redacted)
– EDE Phase
(1, 2, or 3)
– Prospective
EDE Entity
Primary Point
of Contact
(POC) name,
email, and
phone
number. The
Primary POC
should be a
person who is
able to make
decisions on
behalf of the
entity
– Prospective
EDE Entity
Technical
POC name,
email, and
phone
number. The
Technical
POC should
be a person





The
Prospective
Primary and
Prospective
Phase Change
EDE Entity
must email
directenrollme
nt@cms.hhs.g
ov
Subject line
should state:
“Enhanced
DE: Intent.”

57

Prospective
Primary and
Prospective
Phase Change
EDE Entities
Note: CMS is not
collecting
notices of
intent from
prospective
Upstream
EDE
Entities.

March 1

Document

–

–

DE Entity
Documentation
Package—Privacy
Questionnaire (or
attestation, if
applicable, see
Submission
Requirements
column)

Submission
Requirements

Description





Entity
Responsible

Deadline

who manages
technical
development
Prospective
EDE Entity
Emergency
POC name,
email, and
phone
number. The
Emergency
POC should
be a person
who should
be contacted
in an
emergency
situation. 44
CMS-issued
Hub Partner
ID
43F

CMS has provided the
privacy questionnaire
as part of the DE
Entity Documentation
Package available on
CMS zONE.
EDE Entity must
populate the privacy
questionnaire and
return it to CMS for
review.

Submit via the
DE/EDE Entity
PME Site
 If an EDE
Entity’s
responses to
the privacy
questionnaire
are unchanged
from the EDE
Entity’s last
submission of
a privacy
questionnaire,
the Entity may
submit an
attestation
stating that the
previously
submitted
questionnaire
remains
accurate.
– The attestation
must be on
company
letterhead with
a signature
from an officer
with the
authority to
bind the entity
to the
contents.


Prospective
Primary EDE
Entities

Submit with audit
submission

CMS will send EDE related communications to the POCs listed in the EDE Entity’s Notice of Intent to
Participate. EDE Entities can change these POCs at any time by emailing directenrollment@cms.hhs.gov.
44

58

Document
DE Entity
Documentation
Package—Entity’s
website privacy
policy statement(s)
and Terms of
Service (or
attestation, if
applicable; see
Submission
Requirements
column)

Submission
Requirements

Entity
Responsible

Submit via the
DE/EDE PME
Site
 If an EDE
Entity’s privacy
policy and
Terms of
Service remain
unchanged
from the EDE
Entity’s last
submission of
the privacy
policy and
Terms of
Service, the
Entity may
submit an
attestation
stating that the
previously
submitted
privacy policy
and Terms of
Service will
remain
unchanged.
– The attestation
must be on
company
letterhead with
a signature
from an officer
with the
authority to
bind the entity
to the contents

Both Prospective
Primary and
Prospective
Upstream EDE
Entities

Description




Submit the URL and
text of each privacy
policy statement
displayed on your
website and your
website’s Terms of
Service in a Microsoft
Word document or a
PDF.
The privacy policy and
terms of service must
be submitted for any
EDE Entity’s website
that is collecting
Consumer data as
part of the EDE enduser experience.



59

Deadline
Prospective Primary EDE
Entities: Submit with audit
submission.
Prospective Upstream
EDE Entities: Submit
after the Prospective
Primary EDE Entity has
submitted its audit. There
is no deadline to submit
the applicable
components of the DE
Entity documentation
package for prospective
Upstream EDE Entities,
but to be reasonably
certain a prospective
Upstream EDE Entity will
be approved by the start
of the OEP, CMS strongly
recommends that EDE
Entities submit the
required documentation
no later than October 1 or
as soon as feasible to
allow time to review prior
to activating their Partner
IDs.

Document
EDE Business
Agreement





DE Entity
Documentation
Package—
Operational and
Oversight
Information

Submission
Requirements

Description





EDE Entities must
execute the EDE
Business Agreement
to use the EDE
pathway. The
agreement must
identify the Entity’s
selected Auditor(s) (if
applicable).
CMS will countersign
the EDE Business
Agreement after CMS
has reviewed and
approved the EDE
Entity’s business
requirements audit
and the privacy and
security audit.



EDE Entities must
submit the operational
and oversight
information to CMS to
use the EDE pathway.
This form must be
filled out completely.
The form is an Excel
file that the EDE Entity
will complete and
submit to CMS.






Submit via the
DE/EDE Entity
PME Site

Submit via the
DE/EDE Entity
PME Site
Prospective
Primary EDE
Entities will
receive an
encrypted, prepopulated
version of the
form from
CMS
Prospective
Upstream EDE
Entities will
complete a
blank version
of the form that
is available on
CMS zONE

60

Entity
Responsible

Deadline

Both Prospective
Primary and
Prospective
Upstream EDE
Entities

Prospective Primary EDE
Entities: Submit with audit
submission.

Both Prospective
Primary and
Prospective
Upstream EDE
Entities

Prospective Primary EDE
Entities: Submit with audit
submission.

Prospective Upstream
EDE Entities: Submit
after the Prospective
Primary EDE Entity has
submitted its audit. There
is no deadline to submit
the applicable
components of the DE
Entity documentation
package for Prospective
Upstream EDE Entities,
but to be reasonably
certain a Prospective
Upstream EDE Entity will
be approved by the start
of the OEP, CMS strongly
recommends that EDE
Entities submit the
required documentation
no later than October 1 or
as soon as feasible to
allow time to review prior
to activating their Partner
IDs.

Prospective Upstream
EDE Entities: Submit
after the Prospective
Primary EDE Entity has
submitted its audit. There
is no deadline to submit
the applicable
components of the DE
Entity documentation
package for Prospective
Upstream EDE Entities,
but to be reasonably
certain a Prospective
Upstream EDE Entity will
be approved by the start
of the OEP, CMS strongly
recommends that EDE
Entities submit the
required documentation
no later than October 1 or
as soon as feasible to
allow time to review prior
to activating their Partner
IDs.

Document
Business Audit
Report and
Toolkits

Description




Training





HUB Onboarding
Form



Submission
Requirements

Entity
Responsible

Deadline

EDE Entities must
submit the Business
Requirements Audit
Report Template and
all applicable toolkits
completed by its
Auditor(s).
See Section VI.B.ii,
Business
Requirements Audit
Resources, Exhibit 5,
for more information.



The EDE
Entity and its
Auditor(s)
must submit
the different
parts of the
Auditor
resources
package via
the DE/EDE
Entity PME
Site

Prospective
Primary EDE
Entities,
Prospective
Phase Change
EDE Entities,
and their
Auditors

April 1 -July 1 (3:00 AM
ET)

EDE Entities (and their
Auditors must
complete the trainings
as outlined in Section
VIII, Required Auditor
and EDE Entity
Training.
The trainings are
located on REGTAP
(located at the
following link:
https://www.regtap.inf
o/).



The person
taking the
training must
complete the
course
conclusion
pages at the
end of each
module
The EDE
Entity and
Auditor are
NOT required
to submit
anything
additional to
CMS but must
retain a copy
of the training
confirmation
webpage to
provide to
CMS, if
requested

Prospective
Primary EDE
Entities,
Prospective
Phase Change
EDE Entities,
Prospective
Upstream EDE
Entities, and
Auditors

Trainings must be
completed by Prospective
Primary and Phase
Change EDE Entities and
Auditors prior to Audit
Submission

All EDE Entities must
submit a new or
updated Hub
Onboarding Form to
request EDE access.
If an EDE Entity does
not already have a
Partner ID, the Hub
will create a Partner ID
for the EDE Entity
upon receiving the
Hub Onboarding
Form.



Follow
instructions on
the Hub
Onboarding
Form (located
at the following
link:
https://zone.c
ms.gov/docum
ent/hubonboardingform)
Send to
HubSupport@
sparksoftcorp.
com

Prospective
Primary and
Prospective
Upstream EDE
Entities

Prior to accessing the
EDE APIs





61

Prospective Upstream
EDE Entities must
complete the training
prior to approval to use
the EDE pathway

Document
Application
Technical
Assistance and
Mini Audit Testing
Credentials

Submission
Requirements

Description


An EDE Entity must
provide application
technical assistance
and mini audit testing
credentials to CMS
consistent with the
process defined in
Sections VI.C,
Application Technical
Assistance and X.D,
Audit Submission
Compliance Review
for Prospective
Primary EDE Entities,
below.



Follow
instructions on
the EDE UI
Eligibility
Technical
Assistance
Credentials
Form
Template on
CMS zONE:
https://zone.c
ms.gov/docum
ent/eligibilityinformation

62

Entity
Responsible
Prospective
Primary EDE
Entities and
Prospective
Phase Change
EDE Entities

Deadline
Submit with audit
submission date

Document
Interconnection
Security
Agreement (ISA)

Description
 A Prospective Primary
EDE Entity must submit
the ISA to use the EDE
pathway.
 CMS will countersign the
ISA after CMS has
reviewed and approved
the EDE Entity’s business
requirements audit and
privacy and security
audit.

Submission
Requirements
 A Prospective
Primary EDE
Entity must
submit the ISA
via the DE/EDE
Entity PME Site.
 The ISA contains
Appendices that
must be
completed in full
for an EDE Entity
to be considered
for approval.
 Appendix B of the
ISA must detail:
(1) all
arrangements
with Upstream
EDE Entities and
any related data
connections or
exchanges, (2)
any arrangements involving
Web-brokers, and
(3) any
arrangements
with downstream
agents and
brokers that
involve limited
data collections,
as described in
Section IV.B,
Downstream
Third-party Agent
and Broker
Arrangements.
 Appendix B of the
ISA must be
updated and
resubmitted as a
Primary EDE
Entity adds or
changes any of
the arrangements
noted above
consistent with
the requirements
in the ISA.

63

Entity
Responsible
 Prospective
Primary EDE
Entities

Deadline
 Submit with the audit
submission

Document

Description

Submission
Requirements

Entity
Responsible

Deadline

Security Privacy
Controls
Assessment Test
Plan (SAP)

 This report is to be
completed by the Auditor
and submitted to CMS
prior to initiating the audit.
 The SAP describes the
Auditor’s scope and
methodology of the
assessment. The SAP
includes an attestation of
the Auditor’s
independence.

 A Prospective
EDE Entity and
its Auditor must
submit the SAP
completed by its
Auditor via the
DE/EDE Entity
PME Site.

 Prospective
Primary, Hybrid
Issuer
Upstream, and
Hybrid NonIssuer
Upstream EDE
Entities

 At least thirty (30) Days
before commencing the
privacy and security
audit; during the
planning phase

Security Privacy
Assessment
Report (SAR)

 This report details the
Auditor’s assessment
findings of the
Prospective EDE Entity’s
security and privacy
controls implementation.

 A Prospective
EDE Entity and
its Auditor must
submit the SAR
completed by its
Auditor via the
DE/EDE Entity
PME Site.

 Prospective
Primary, Hybrid
Issuer
Upstream, and
Hybrid NonIssuer
Upstream EDE
Entities

 April 1 – July 1 (3:00
AM ET)

64

Document
Plan of Action &
Milestones
(POA&M)

Description
 A Prospective EDE Entity
must submit a POA&M if
its Auditor identifies any
privacy and security
compliance issues in the
SAR.
 The POA&M details a
corrective action plan and
the estimated completion
date for identified
milestones.

Submission
Requirements

Entity
Responsible

 A Prospective
EDE Entity and
its Auditor must
submit the
POA&M in
conjunction with
the SAR via the
DE/EDE Entity
PME Site.
 POA&Ms with
outstanding
findings must be
submitted
monthly to CMS
until all the
findings from
security controls
assessments,
security impact
analyses, and
continuous
monitoring
activities
described in the
NEE SSP
controls CA-5 and
CA-7 are
resolved.
Prospective EDE
Entities can
schedule their
own time for
monthly
submissions of
the POA&M, but
must submit an
update monthly to
CMS until all
significant or
major findings are
resolved.
Thereafter,
quarterly POA&M
submissions are
required as part
of the ISCM
activities.

 Prospective
Primary, Hybrid
Issuer
Upstream, and
Hybrid NonIssuer
Upstream EDE
Entities

65

Deadline
 Initial: April 1 – July 1
(3:00 AM ET)
 Monthly submissions,
as necessary, if
outstanding findings.
 Thereafter, consistent
with the ISCM Strategy
Guide, EDE Entities
must submit quarterly
POA&Ms by the last
business Day of March,
July, September, and
December.

Document

Description

Submission
Requirements

Entity
Responsible

Deadline

Risk Acceptance
Form

 The Risk Acceptance
Form records the
weaknesses that require
an official risk acceptance
from the organization’s
Authorizing Official.
 Before deciding to accept
the risks, the relevant
NEE’s authorities should
rigorously explore ways
to mitigate the risks.

 Once the risk has
been identified
and deemed
acceptable by the
NEE’s authorized
official, the NEE
must complete
the entire Risk
Acceptance Form
and submit the
completed form to
CMS. The NEE
will continue to
track all accepted
risks in the NEE’s
official POA&M.

 Prospective
Primary, Hybrid
Issuer
Upstream, and
Hybrid NonIssuer
Upstream EDE
Entities

 The Risk Acceptance
Form should be
submitted with the
POA&M during the
regular POA&M
submission schedule.

Privacy Impact
Assessment (PIA)

 The PIA will detail the
Prospective EDE Entity’s
evaluation of its controls
for protecting PII.

 A Prospective
EDE Entity is not
required to submit
the PIA to CMS.
However, per the
ISA, CMS may
request and
review an EDE
Entity’s PIA at
any time,
including for audit
purposes.

 Prospective
Primary, Hybrid
Issuer
Upstream, and
Hybrid NonIssuer
Upstream EDE
Entities

 Before commencing the
privacy and security
audit as part of the NEE
SSP

Non-Exchange
Entity System
Security and
Privacy Plan (NEE
SSP)

 The NEE SSP will include
detailed information
about the Prospective
EDE Entity’s
implementation of
required security and
privacy controls.

 A Prospective
Primary EDE
Entity must
submit the
completed NEE
SSP via the
DE/EDE Entity
PME Site before
commencing the
privacy and
security audit.
 The
implementation of
security and
privacy controls
must be
completely
documented in
the NEE SSP
before the audit is
initiated.

 Prospective
Primary and
Hybrid NonIssuer
Upstream EDE
Entities

 Before commencing the
privacy and security
audit

66

Document

Description

Incident Response
Plan and Incident/
Breach Notification
Plan

 A Prospective EDE Entity
is required to implement
Breach and Incident
handling procedures that
are consistent with CMS’
Incident and Breach
Notification Procedures.
 A Prospective EDE Entity
must incorporate these
procedures into its own
written policies and
procedures. 45
44F

Submission
Requirements

Entity
Responsible

 A Prospective
EDE Entity is not
required to submit
the Incident
Response Plan
and
Incident/Breach
Notification Plan
to CMS. A
Prospective EDE
Entity must have
procedures in
place to meet
CMS security and
privacy Incident
reporting
requirements.
CMS may request
and review an
EDE Entity’s
Incident
Response Plan
and
Incident/Breach
Notification Plan
at any time,
including for audit
purposes.

 Prospective
Primary, Hybrid
Issuer
Upstream, and
Hybrid NonIssuer
Upstream EDE
Entities

https://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-InformationTechnology/InformationSecurity/Downloads/RMH-Chapter-08-Incident-Response.pdf.
45

67

Deadline
 Before commencing the
privacy and security
audit as part of the NEE
SSP

Annual Penetration
Testing

 The penetration test must
include the EDE
environment and must
include tests based on
the Open Web
Application Security
Project (OWASP) Top
10.
 Before conducting the
penetration testing, the
EDE Entity must execute
a Rules of Engagement
with their Auditor’s
penetration testing team.
 The EDE Entity must
also notify their CMS
designated technical
counterparts on their
annual penetration
testing schedule and
must provide the
following information to
CMS, a minimum of five
(5) business Days using
the CMS-provided
form 46, prior to initiation
of the penetration testing:
– Period of testing
performance
(specific times for
all penetration
testing should be
contained in
individual test
plans);
– Target
environment
resources to be
tested (IP
addresses,
Hostname, URL);
and
– Any restricted
hosts, systems, or
subnets that are
not to be tested.
 During the penetration
testing, the Auditor’s
testing team shall not
target IP addresses used
for the CMS and NonCMS Organization
connection and shall not
conduct penetration
testing in the production
environment.
 The penetration testing
shall be conducted in the
lower environment that
mirrors the production
environment.

 A Prospective
EDE Entity and
its Auditor must
submit the
Penetration Test
results with the
SAR via the
DE/EDE Entity
PME Site.

45F

68

 Prospective
Primary,
Hybrid Issuer
Upstream, and
Hybrid NonIssuer
Upstream EDE
Entities

 Initial: April 1 – July 1
(3:00 AM ET)
 Thereafter, consistent
with the ISCM Strategy
Guide, EDE Entities
perform penetration
testing and submit
results to CMS
annually, prior to last
business Day in July.

Document

Description

Vulnerability Scan

 A Prospective EDE Entity
is required to conduct
monthly Vulnerability
Scans.

Submission
Requirements

Entity
Responsible

Deadline

 A Prospective
EDE Entity and
its Auditor must
submit the last
three months of
their Vulnerability
Scan Reports, in
conjunction with
POA&M and SAR
via the DE/EDE
Entity PME Site.
 All findings from
vulnerability
scans are
expected to be
consolidated in
the monthly
POA&M.
 Similar findings
can be
consolidated.

 Prospective
Primary, Hybrid
Issuer
Upstream, and
Hybrid NonIssuer
Upstream EDE
Entities.

 Initial: April 1 – July 1
(3:00 AM ET)
 Thereafter, consistent
with the ISCM Strategy
Guide, EDE Entities
must submit
Vulnerability Scans
annually.

The Penetration Testing Notification Form is available at the following link:
https://zone.cms.gov/document/privacy-and-security-audit.
46

69

APPENDIX E: AUDITOR IDENTIFICATION
EDE Entity agrees to identify, in Part I below, all Auditors selected to complete the Operational
Readiness Review (ORR) and any subcontractors of the Auditor(s), if applicable. In the case of
multiple Auditors, please indicate the role of each Auditor in completing the ORR (i.e., whether
the Auditor will conduct the business requirements audit and/or the privacy and security audit,
including the completion of an annual assessment of security and privacy controls by an Auditor,
as described in the Information Security and Privacy Continuous Monitoring (ISCM) Strategy
Guide). Include additional sheets, if necessary. EDE Entity must identify the ISCM Auditor that
conducted the ISCM immediately preceding this Agreement’s submission and execution.
If an Upstream EDE Entity will contract with an Auditor to audit additional functionality or
systems added to its Primary EDE Entity’s EDE Environment, pursuant to Section VIII.g or
VIII.h of this Agreement, complete Part I to indicate the Auditor(s) that will conduct the business
requirements audit and/or privacy and security audit of the additional functionality or systems.
All capitalized terms used herein carry the meanings assigned in Appendix B: Definitions. Any
capitalized term that is not defined in the Agreement, this Appendix or in Appendix B:
Definitions has the meaning provided in 45 C.F.R. § 155.20.

TO BE FILLED OUT BY EDE ENTITY
Primary EDE Entities, Hybrid Issuer Upstream EDE Entities, and Hybrid Non-Issuer Upstream
EDE Entities must complete Part I.
I.

Complete These Rows if EDE Entity Is Subject to an Audit (ORR, ISCM, and/or
Supplemental Audit)

Printed Name and Title of Authorized
Official of Auditor 1
Auditor 1 Business Name
Auditor 1 Address
Printed Name and Title of Contact of
Auditor 1 (if different from
Authorized Official)
Auditor 1 Contact Phone Number
Auditor 1 Contact Email Address
Subcontractor Name & Information
(if applicable)
Audit Role
Printed Name and Title of Authorized
Official of Auditor 2
Auditor 2 Business Name
Auditor 2 Address

70

Printed Name and Title of Contact of
Auditor 2 (if different from
Authorized Official)
Auditor 2 Contact Phone Number
Auditor 2 Contact Email Address
Subcontractor Name & Information
(if applicable)
Audit Role
Printed Name and Title of Authorized
Official of Auditor 3
Auditor 3 Business Name
Auditor 3 Address
Printed Name and Title of Contact of
Auditor 3 (if different from
Authorized Official)
Auditor 3 Contact Phone Number
Auditor 3 Contact Email Address
Subcontractor Name & Information
(if applicable)
Audit Role

71

APPENDIX F: CONFLICT OF INTEREST DISCLOSURE FORM
TO BE FILLED OUT BY EDE ENTITY
EDE Entity must disclose to the Department of Health & Human Services (HHS) any financial
relationships between the Auditor(s) identified in Appendix E of this agreement, and individuals
who own or are employed by the Auditor(s), and individuals who own or are employed by a
Direct Enrollment (DE) Entity for which the Auditor(s) is conducting an Operational Readiness
Review pursuant to 45 C.F.R. § 155.221(b)(4) and (f). EDE Entity must disclose any affiliation
that may give rise to any real or perceived conflicts of interest, including being free from
personal, external, and organizational impairments to independence, or the appearance of such
impairments to independence.
All capitalized terms used herein carry the meanings assigned in Appendix B: Definitions. Any
capitalized term that is not defined in the Agreement, this Appendix or in Appendix B:
Definitions has the meaning provided in 45 C.F.R. § 155.20.
Please describe below any relationships, transactions, positions (volunteer or otherwise), or
circumstances that you believe could contribute to a conflict of interest:
☐ Not applicable; EDE Entity is not contracting with an Auditor.
☐ EDE Entity has no conflict of interest to report for the Auditor(s) identified in Appendix E.
☐ EDE Entity has the following conflict of interest to report for the Auditor(s) identified in
Appendix E:
1.

2.

3.

72

APPENDIX G: APPLICATION END-STATE PHASES
The below table describes each of the three end-state phases for hosting applications using the
EDE Pathway. 47 EDE Entity must indicate the end-state phase it has selected in the “Operational
and Oversight Information” form provided by CMS. All capitalized terms used herein carry the
meanings assigned in Appendix B: Definitions. Any capitalized term that is not defined in the
Agreement, this Appendix or in Appendix B: Definitions has the meaning provided in 45 C.F.R.
§ 155.20.
46F

End State Phases

Description

Phase 1: Host
Simplified
Application + EDE
API Suite

EDE Entity hosts an application that cannot support all application
scenarios. The scenarios supported include the following:
 Application filer (and others on application, if applicable)
resides in the application state and all dependents have the
same permanent address, if applicable
 Application filer plans to file a federal income tax return for
the coverage year; if married plans to file a joint federal
income tax return with spouse
 Application filer (and spouse, if applicable) is not responsible
for a child 18 or younger who lives with the Application filer
but is not on his/her federal income tax return
 No household members are full-time students aged 18-22
 No household member is pregnant
 All Applicants are U.S. citizens
 All Applicants can enter Social Security Numbers (SSNs)
 No Applicants are applying under a name different than the
one on his/her Social Security cards
 No Applicants were born outside of the U.S. and became
naturalized or derived U.S. citizens
 No Applicants are currently incarcerated (detained or jailed)
 No household members are American Indian or Alaska
Native
 No Applicants are offered health coverage through a job or
COBRA
 No Applicants are offered an individual coverage health
reimbursement arrangement (HRA) or qualified small
employer health reimbursement arrangement (QSEHRA)
 No Applicants were in foster care at age 18 and are currently
25 or younger
 All dependents are claimed on the Application filer's federal
income tax return for the coverage year
 All dependents are the Application filer's children who are
single (not married) and 25 or younger
 No dependents are stepchildren or grandchildren
 No dependents live with a parent who is not on the
Application filer's federal income tax return

Benefits
Lowest level of effort to
implement and audit. EDE
development would be
streamlined, since not all
application questions would be
in scope.

The table in Appendix G is an updated version of Exhibit 3 in the “Third-party Auditor Operational Readiness
Reviews for the Enhanced Direct Enrollment Pathway and Related Oversight Requirements.”
47

73

End State Phases

Description

Phase 2: Host
Expanded
Simplified
Application + EDE
API Suite

EDE Entity hosts an application that cannot support all application
scenarios. The scenarios supported include the following:
 All scenarios covered by Phase 1
 Full-time student
 Pregnant application members
 Non-U.S. citizens
 Naturalized U.S. citizens
 Application members who do not provide an SSN
 Application members with a different name than the one on
their SSN cards
 Incarcerated application members
 Application members who previously were in foster care
 Stepchildren

Second lowest level of effort to
implement and audit. EDE
development would be
streamlined, since not all
application questions would be
in scope.

Phase 3: Host
Complete
Application + EDE
API Suite

EDE Entity hosts an application that supports all application
scenarios (equivalent to existing HealthCare.gov):
 All scenarios covered in Phase 2
 American Indian and Alaskan Native household members
 Application members with differing home addresses or
residing in a State separate from where they are applying for
coverage
 Application members with no home address
 Application members not planning to file a tax return
 Married application members not filing jointly
 Application members responsible for a child age 18 or
younger who lives with them, but is not included on the
Application filer’s federal income tax return (parent/caretaker
relative questions)
 Application members offered coverage through their job,
someone else’s job, or COBRA
 Application members with dependent children who are over
age 25 or who are married
 Application members with dependent children living with a
parent not on their federal income tax return
 Dependents who are not sons/daughters
 Applicants who are offered an individual coverage HRA or
QSEHRA

Highest level of effort to
implement and audit. EDE Entity
would provide and service the
full range of Consumer
scenarios. Additionally, the EDE
Entity would no longer need to
redirect Consumers to
alternative pathways for
complex eligibility scenarios.
Please note that the
implementation of Phase 3 is
comparatively more complex
than the other phases and may
require more time to implement,
audit, and approve.

74

Benefits

APPENDIX H: TECHNICAL AND TESTING STANDARDS
FOR USING THE EDE PATHWAY
All capitalized terms used herein carry the meanings assigned in Appendix B: Definitions. Any
capitalized term that is not defined in the Agreement, this Appendix or in Appendix B:
Definitions the meaning provided in 45 C.F.R. § 155.20.
(1)

EDE Entity must possess a unique Partner ID assigned by the Centers for Medicare &
Medicare Services (CMS). EDE Entity must use its Partner ID when interacting with
the CMS Data Services Hub (Hub) and the EDE Application Program Interfaces
(APIs) for EDE Entity’s own line of business.
If EDE Entity uses a Primary EDE Entity’s EDE Environment, EDE Entity must use
its own Partner ID when interacting with the Hub and the EDE APIs. If EDE Entity is
a Primary EDE Entity and provides an EDE Environment to another EDE Entity, as
permitted under Section VIII.f, VIII.g, and VIII.h of this Agreement, the Primary
EDE Entity must use the Partner ID assigned to the EDE Entity using its EDE
Environment for any Hub or EDE API interactions for the other EDE Entity. If EDE
Entity is a Primary EDE Entity, it must provide to CMS the Partner IDs of all entities
that will implement and use Primary EDE Entity’s EDE Environment.

(2)

(3)

CMS will provide EDE Entity with information outlining EDE API Specifications
and with EDE-related Companion Guides, including the EDE Companion Guide, the
Federally-facilitated Exchange (FFE) User Interface (UI) Application Principles for
Integration with FFE APIs, and the UI Question Companion Guide, which is
embedded within the FFE UI Application Principles for Integration with FFE APIs.
The terms of these documents are specifically incorporated herein. EDE Entity’s use
of the EDE Environment must comply with any standards detailed in the EDE API
Specifications guidance and the EDE-related Companion Guides.
EDE Entity must complete testing for each Hub-related transaction it will implement,
and it shall not be allowed to exchange data with CMS in production mode until
testing is satisfactorily passed, as determined by CMS in its sole discretion.
Successful testing generally means the ability to pass approved standards, and to
process data transmitted by EDE Entity to the Hub. The capability to submit these test
transactions must be maintained by EDE Entity throughout the term of this
Agreement.

(4)

EDE Entity agrees to submit test transactions to the Hub prior to the submission of
any transactions to the FFE production system, and to determine that the transactions
and responses comply with all requirements and specifications approved by CMS
and/or the CMS contractor.

(5)

EDE Entity agrees that prior to the submission of any additional transaction types to
the FFE production system, or as a result of making changes to an existing transaction
type or system, it will submit test transactions to the Hub in accordance with
paragraph (3) and (4) above.
75

(6)

EDE Entity acknowledges that CMS requires successful completion of an Operational
Readiness Review (ORR) to the satisfaction of CMS, which must occur before EDE
Entity is able to execute an ISA with CMS or submit any transactions using its EDE
Environment to the FFE production system. The ORR will assess EDE Entity’s
compliance with CMS’ regulatory requirements, this Agreement, and the
Interconnection Security Agreement (ISA), including the required privacy and
security controls. This Agreement may be terminated or access to CMS systems may
be denied for a failure to comply with CMS requirements in connection to an ORR.

(7)

Upon approval for a significant change in the EDE Environment, including, but not
limited to, initial approval to go-live with an EDE Environment, approval to go-live
with an end-state phase change, or approval to proceed with a significant change to
EDE Environment functionality, EDE Entity will limit enrollment volume in its
production environment in accordance with the scale and schedule set by CMS, in its
sole discretion, until CMS has verified the successful implementation of the EDE
Entity’s EDE Environment in production.

(8)

CMS, in its sole discretion, may restrict, delay, or deny an EDE Entity’s ability to
implement a significant change in the EDE Environment, consistent with paragraph
(7) of this Appendix, if an EDE Entity has not maintained compliance with program
requirements or the EDE Entity has triggered the conditions for Inactive, Approved
Primary EDE Entities (Section IX.v of this Agreement). Failure to maintain
compliance with program requirements includes, but is not limited to, an inability to
meet CMS-issued deadlines for CMS-initiated Change Requests (Section IX.d of this
Agreement) or failure to maintain an EDE Environment that complies with the
standards detailed in the EDE API Specifications guidance and the EDE-related
Companion Guides.

(9)

All compliance testing (Operational, Management and Technical) of EDE Entity will
occur at a FIPS 199 MODERATE level due to the Personally Identifiable Information
(PII) data that will be contained within EDE Entity’s systems.

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