Patient-Provider Selected Dispute Resolution Entity Certification – First-Time/Initial

Requirements Related to No Surprise Billing Act, Part II (CMS-10791)

CMS-10791 - 5. HHS - Appendix SDR Entity Certification Data Elements_508c

Patient-Provider Selected Dispute Resolution Entity Certification – First-Time/Initial

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APPENDIX 5
Patient-Provider Selected Dispute Resolution (SDR) Entity Certification Application
Data Elements
The Departments of the Treasury, Labor and Health and Human Services (the Departments)
have issued the Requirements Related to Surprise Billing; Part II interim final rule (XX FR
XXXXX), which provides protections for the uninsured. This rule requires the Secretary of
HHS to establish a process referred to as patient-provider dispute resolution process. Under
this process, an uninsured (or self-pay) individual may seek a determination from an SDR
entity for any billed charges from a provider or facility that are substantially in excess of the
good faith estimate provided by the health care provider or facility in advance of receiving
the items or services. These requirements provide for an SDR entity to review and make an
independent, binding determination of the payment amount for items and services. These
SDR entities must be certified by the Secretary under 45 CFR 149.620(d). HHS intends to
contract with between 1 and 3 SDR entities that meet the certification requirements outlined
in 45 CFR 149.620(d) rather than pursue an open certification process as is the case for
certified IDR entities in the federal IDR process.
The tables below identify data elements that an organization seeking to become an SDR
entity is required to include in the contracting process.
SDR Entity Application for Certification
DATA ELEMENT
General Company
Information
Legal SDR entity Name and
trade name (DBA) if
applicable
SDR entity Address
SDR entity Website
Tax ID Type and Number

Primary Contact Information
Secondary Contact
Information
Expertise

DESCRIPTION

SDR entity’s legal name as written on their business
license, and DBA if applicable
SDR entity’s physical address, including street name and
number, city, state, and zip code
SDR entity’s uniform resource locator (URL) linked to the
home webpage (e.g., www.SDR entity.org)
SDR entity’s taxpayer identification number (TIN),
employer identification number (EIN), or federal tax
identification number (FEIN) issued by the Internal
Revenue Service, and type of number
First name, last name, phone number, and email address of
the person representing the SDR entity on the application
First name, last name, phone number, and email address of
an additional person, other than the primary contact,
representing the SDR entity on the application
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Documentation to prove
expertise

Organization Structure and
Staffing Plan
Organization Chart

Staffing Plan

Conflict of Interest
Attestation
Organizational Attestation
of No Conflicts of Interest

Indicators of Fiscal
Integrity and Stability
Documentation to prove
fiscal integrity and stability

Verification (e.g. staff members’ resumes or CVs showing
experience) that SDR entity has requisite medical and legal
expertise, including in healthcare and air-space laws, and
sufficient experience in arbitration and claims
administration, managed care, and billing and coding.
Additional expertise and documentation may be submitted
optionally for consideration as desired.*
A graphic representation of the structure of the SDR entity
showing the hierarchy of the organization and the
relationships within it, including any parent or subsidiary
entities. SDR Entities must not be owned by a subsidiary
of, or associated or affiliated with a plan, issuer, provider,
provider of air ambulance services.
Document that describes the credentials, responsibilities,
and number of personnel employed to make
determinations. This should also include policies and
procedures governing the allocation of staff to case
arbitration, including the credentials and responsibilities of
staff that will be arbitrating cases, as well as policies and
procedures for ensuring proper verification of credentials.
Documentation should also show operations and
infrastructure to effectively and efficiently manage the
arbitration process, including delegation of functions and
oversight of the process, and applicable procedures for
using contractors to fill expertise vacancies so
determinations can be completed within the required time
period.
An attestation indicating the SDR Entity is not (1) a
provider or a facility; (2) not an affiliate or subsidiary of a
provider or a facility; or (3) an affiliate or subsidiary of a
professional or trade association representing providers or
facilities.
Documentation describing a system of safeguards and
controls in place to prevent and detect improper financial
activities by employees and other affiliated persons to
assure the fiscal integrity and accountability for all fees
received and held, and three most recent years of SDR
entity’s balance sheets, income statements, cash flow
statements, and statements of changes in owners’ equity (if
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Internal Controls to Hold
Fees
Internal Controls to Hold
Administrative Fees

Conflict of Interest Audit
Standards
Conflict of Interest
Mitigation Policies

Proof of Accreditation or
Arbitration Training
Document(s) to
demonstration proof of
Accreditation or Arbitration
Training

Confidential Health
Information
Confidential Health
Information Standards

applicable) or other documentation to demonstrate fiscal
stability.
Policies and procedures to retain the administrative fees
paid by the initiating party during the initiation of the
dispute resolution process in a trust or escrow account
separate from other funds, remit funds to CMS, and prevent
fraud, abuse, or waste of funds held.
Information on the SDR entity’s conflict-of-interest
policies and procedures, including outlining a mitigation
plan in the event of an entity-level conflict of interest,
under which no dispute resolution personnel affiliated with
the SDR entity can fairly and impartially adjudicate a case,
in compliance with the standards in Federal Acquisition
Regulation subpart 9.5
Documentation proving current accreditation by a certified
accreditation body, such as URAC, or that the SDR entity
otherwise possesses the requisite training to conduct
payment determinations (for example, providing
documentation that personnel have competed arbitration
training by the American Arbitration Association,
American Health Law Association, or a similar
organization).
Written policies and procedures to protect the
confidentially of IIHI as outlined in the interim final rules
for Requirements Related to Surprise Billing: Part II,
including how the certified SDR Entity will: ensure the
confidentiality, integrity, and availability of all IIHI they
create, obtain, maintain, store, or transmit; protect against
any reasonably anticipated threats or hazards to the security
or integrity of IIHI; protect against unauthorized use or
disclosure of IIHI by their personnel; securely destroy or
dispose of IIHI; monitor, periodically assess, and update
security controls and related systems risks to ensure the
continued effectiveness of those controls; and in the event
of a breach in unsecure IIHI, conduct a risk assessment to
determine the nature and extent of the breach, and provide
notifications to the Departments and all parties affected by
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the breach.
Internal Controls to Support
Reporting Compliance
Reporting Plan

Policies and Procedures for
Subcontracting
Subcontractor Management
Plan

Policies and Procedures for
Compliance with Federal
Civil Rights Laws
Nondiscrimination Policies
and Procedures

Policies and procedures outlining your organization’s
ability to comply with reporting requirements stipulated in
the regulation, including properly collecting and storing all
required information and how this will be reported out to
the Departments.
Documentation describing the organization’s policies and
procedures for managing subcontractors, including how the
organization will ensure that subcontractors assigned to a
determination do not have a conflict of interest regarding
any party to the dispute, and how the organization will
ensure that subcontractors protect IIHI, in the same manner
as required of certified SDR Entities.

Policies and procedures for ensuring compliance with
federal civil rights laws that prohibit discrimination,
including section 1557 of the Affordable Care Act, title VI
of the Civil Rights Act of 1964, sections 504 and 508 of the
Rehabilitation Act of 1973, and 45 CFR part 92.

Contract with Secretary to Meet Certified SDR Entity Standards and Procedures
DATA ELEMENT
DESCRIPTION
Standards and Procedures as
Determined by the Secretary

Contract detailing standards and procedures determined by
the Secretary through guidance for SDR entities.

*Denotes optional submission

Paperwork Reduction Act Statement
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a
collection of information unless it displays a valid Office of Management and Budget
(OMB) control number. The Departments are seeking OMB approval for the model as part
of the approval for a new OMB control number 0938-XXXX. The time required to complete
this information collection is estimated to average of 5.25 hours per respondent, including
the time to review instructions, search existing data resources, gather the data needed, and
complete and review the information collection. If you have comments concerning the
accuracy of the time estimate(s) or suggestions for improving this form, please write to:
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CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail Stop C4-26-05,
Baltimore, Maryland 21244-1850.

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File TitlePatient-Provider Selected Dispute Resolution (SDR) Entity Certification Application
File Modified2021-09-24
File Created2021-09-23

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