42 USC 1320d-2 - Standards for information transactions and data elements

U.S Code last checked for updates: May 03, 2024

§ 1320d–2.

Standards for information transactions and data elements

(a)

Standards to enable electronic exchange

(1)

In general

The Secretary shall adopt standards for transactions, and data elements for such transactions, to enable health information to be exchanged electronically, that are appropriate for—

(A)

the financial and administrative transactions described in paragraph (2); and

(B)

other financial and administrative transactions determined appropriate by the Secretary, consistent with the goals of improving the operation of the health care system and reducing administrative costs, and subject to the requirements under paragraph (5).

(2)

Transactions

The transactions referred to in paragraph (1)(A) are transactions with respect to the following:

(A)

Health claims or equivalent encounter information.

(B)

Health claims attachments.

(C)

Enrollment and disenrollment in a health plan.

(D)

Eligibility for a health plan.

(E)

Health care payment and remittance advice.

(F)

Health plan premium payments.

(G)

First report of injury.

(H)

Health claim status.

(I)

Referral certification and authorization.

(J)

Electronic funds transfers.

(3)

Accommodation of specific providers

(4)

Requirements for financial and administrative transactions

(A)

In general

The standards and associated operating rules adopted by the Secretary shall—

(i)

to the extent feasible and appropriate, enable determination of an individual’s eligibility and financial responsibility for specific services prior to or at the point of care;

(ii)

be comprehensive, requiring minimal augmentation by paper or other communications;

(iii)

provide for timely acknowledgment, response, and status reporting that supports a transparent claims and denial management process (including adjudication and appeals); and

(iv)

describe all data elements (including reason and remark codes) in unambiguous terms, require that such data elements be required or conditioned upon set values in other fields, and prohibit additional conditions (except where necessary to implement State or Federal law, or to protect against fraud and abuse).

(B)

Reduction of clerical burden

(5)

Consideration of standardization of activities and items

(A)

In general

For purposes of carrying out paragraph (1)(B), the Secretary shall solicit, not later than January 1, 2012, and not less than every 3 years thereafter, input from entities described in subparagraph (B) on—

(i)

whether there could be greater uniformity in financial and administrative activities and items, as determined appropriate by the Secretary; and

(ii)

whether such activities should be considered financial and administrative transactions (as described in paragraph (1)(B)) for which the adoption of standards and operating rules would improve the operation of the health care system and reduce administrative costs.

(B)

Solicitation of input

For purposes of subparagraph (A), the Secretary shall seek input from—

(i)

the National Committee on Vital and Health Statistics, the Health Information Technology Policy Committee, and the Health Information Technology Standards Committee; and

(ii)

standard setting organizations and stakeholders, as determined appropriate by the Secretary.

(b)

Unique health identifiers

(1)

In general

(2)

Use of identifiers

(c)

Code sets

(1)

In general

The Secretary shall adopt standards that—

(A)

select code sets for appropriate data elements for the transactions referred to in subsection (a)(1) from among the code sets that have been developed by private and public entities; or

(B)

establish code sets for such data elements if no code sets for the data elements have been developed.

(2)

Distribution

(d)

Security standards for health information

(1)

Security standards

The Secretary shall adopt security standards that—

(A)

take into account—

(i)

the technical capabilities of record systems used to maintain health information;

(ii)

the costs of security measures;

(iii)

the need for training persons who have access to health information;

(iv)

the value of audit trails in computerized record systems; and

(v)

the needs and capabilities of small health care providers and rural health care providers (as such providers are defined by the Secretary); and

(B)

ensure that a health care clearinghouse, if it is part of a larger organization, has policies and security procedures which isolate the activities of the health care clearinghouse with respect to processing information in a manner that prevents unauthorized access to such information by such larger organization.

(2)

Safeguards

Each person described in section 1320d–1(a) of this title who maintains or transmits health information shall maintain reasonable and appropriate administrative, technical, and physical safeguards—

(A)

to ensure the integrity and confidentiality of the information;

(B)

to protect against any reasonably anticipated—

(i)

threats or hazards to the security or integrity of the information; and

(ii)

unauthorized uses or disclosures of the information; and

(C)

otherwise to ensure compliance with this part by the officers and employees of such person.

(e)

Electronic signature

(1)

Standards

(2)

Effect of compliance

(f)

Transfer of information among health plans

(g)

Operating rules

(1)

In general

(2)

Operating rules development

In adopting operating rules under this subsection, the Secretary shall consider recommendations for operating rules developed by a qualified nonprofit entity that meets the following requirements:

(A)

The entity focuses its mission on administrative simplification.

(B)

The entity demonstrates a multi-stakeholder and consensus-based process for development of operating rules, including representation by or participation from health plans, health care providers, vendors, relevant Federal agencies, and other standard development organizations.

(C)

The entity has a public set of guiding principles that ensure the operating rules and process are open and transparent, and supports nondiscrimination and conflict of interest policies that demonstrate a commitment to open, fair, and nondiscriminatory practices.

(D)

The entity builds on the transaction standards issued under Health Insurance Portability and Accountability Act of 1996.

(E)

The entity allows for public review and updates of the operating rules.

(3)

Review and recommendations

The National Committee on Vital and Health Statistics shall—

(A)

advise the Secretary as to whether a nonprofit entity meets the requirements under paragraph (2);

(B)

review the operating rules developed and recommended by such nonprofit entity;

(C)

determine whether such operating rules represent a consensus view of the health care stakeholders and are consistent with and do not conflict with other existing standards;

(D)

evaluate whether such operating rules are consistent with electronic standards adopted for health information technology; and

(E)

submit to the Secretary a recommendation as to whether the Secretary should adopt such operating rules.

(4)

Implementation

(A)

In general

(B)

Adoption requirements; effective dates

(i)

Eligibility for a health plan and health claim status

(ii)

Electronic funds transfers and health care payment and remittance advice

The set of operating rules for electronic funds transfers and health care payment and remittance advice transactions shall—

(I)

allow for automated reconciliation of the electronic payment with the remittance advice; and

(II)

be adopted not later than July 1, 2012, in a manner ensuring that such operating rules are effective not later than January 1, 2014.

(iii)

Health claims or equivalent encounter information, enrollment and disenrollment in a health plan, health plan premium payments, referral certification and authorization

(C)

Expedited rulemaking

(h)

Compliance

(1)

Health plan certification

(A)

Eligibility for a health plan, health claim status, electronic funds transfers, health care payment and remittance advice

(B)

Health claims or equivalent encounter information, enrollment and disenrollment in a health plan, health plan premium payments, health claims attachments, referral certification and authorization

(2)

Documentation of compliance

A health plan shall provide the Secretary, in such form as the Secretary may require, with adequate documentation of compliance with the standards and operating rules described under paragraph (1). A health plan shall not be considered to have provided adequate documentation and shall not be certified as being in compliance with such standards, unless the health plan—

(A)

demonstrates to the Secretary that the plan conducts the electronic transactions specified in paragraph (1) in a manner that fully complies with the regulations of the Secretary; and

(B)

provides documentation showing that the plan has completed end-to-end testing for such transactions with their partners, such as hospitals and physicians.

(3)

Service contracts

(4)

Certification by outside entity

(5)

Compliance with revised standards and operating rules

(A)

In general

A health plan (including entities described under paragraph (3)) shall file a statement with the Secretary, in such form as the Secretary may require, certifying that the data and information systems for such plan are in compliance with any applicable revised standards and associated operating rules under this subsection for any interim final rule promulgated by the Secretary under subsection (i) that—

(i)

amends any standard or operating rule described under paragraph (1) of this subsection; or

(ii)

establishes a standard (as described under subsection (a)(1)(B)) or associated operating rules (as described under subsection (i)(5)) for any other financial and administrative transactions.

(B)

Date of compliance

(6)

Audits of health plans

(i)

Review and amendment of standards and operating rules

(1)

Establishment

(2)

Evaluations and reports

(A)

Hearings

(B)

Report

(3)

Interim final rulemaking

(A)

In general

(B)

Public comment

(i)

Public comment period

(ii)

Effective date

(4)

Review committee

(A)

For the purposes of this subsection, the term “review committee’ means a committee chartered by or within the Department of Health and Human services that has been designated by the Secretary to carry out this subsection, including—

(i)

the National Committee on Vital and Health Statistics; or

(ii)

any appropriate committee as determined by the Secretary.

(B)

Coordination of HIT standards

(5)

Operating rules for other standards adopted by the Secretary

(j)

Penalties

(1)

Penalty fee

(A)

In general

Not later than April 1, 2014, and annually thereafter, the Secretary shall assess a penalty fee (as determined under subparagraph (B)) against a health plan that has failed to meet the requirements under subsection (h) with respect to certification and documentation of compliance with—

(i)

the standards and associated operating rules described under paragraph (1) of such subsection; and

(ii)

a standard (as described under subsection (a)(1)(B)) and associated operating rules (as described under subsection (i)(5)) for any other financial and administrative transactions.

(B)

Fee amount

(C)

Additional penalty for misrepresentation

(D)

Annual fee increase

(E)

Penalty limit

A penalty fee assessed against a health plan under this subsection shall not exceed, on an annual basis—

(i)

an amount equal to $20 per covered life under such plan; or

(ii)

an amount equal to $40 per covered life under the plan if such plan has knowingly provided inaccurate or incomplete information (as described under subparagraph (C)).

(F)

Determination of covered individuals

(2)

Notice and dispute procedure

(3)

Penalty fee report

(4)

Collection of penalty fee

(A)

In general

(B)

Notice

(C)

Payment due date

(D)

Unpaid penalty fees

Any amount of a penalty fee assessed against a health plan under this subsection for which payment has not been made by the due date provided under subparagraph (C) shall be—

(i)

increased by the interest accrued on such amount, as determined pursuant to the underpayment rate established under section 6621 of the Internal Revenue Code of 1986; and

(ii)

treated as a past-due, legally enforceable debt owed to a Federal agency for purposes of section 6402(d) of the Internal Revenue Code of 1986.

(E)

Administrative fees

(Aug. 14, 1935, ch. 531, title XI, § 1173, as added Pub. L. 104–191, title II, § 262(a), Aug. 21, 1996, 110 Stat. 2024; amended Pub. L. 111–148, title I, § 1104(b)(2), title X, § 10109(a), Mar. 23, 2010, 124 Stat. 147, 915.)

cite as: 42 USC 1320d-2