CITE
42 USC Sec. 1320d-4 01/08/2008
EXPCITE
TITLE 42 - THE PUBLIC HEALTH AND WELFARE
CHAPTER 7 - SOCIAL SECURITY
SUBCHAPTER XI - GENERAL PROVISIONS, PEER REVIEW, AND ADMINISTRATIVE
SIMPLIFICATION
Part C - Administrative Simplification
HEAD
Sec. 1320d-4. Requirements
STATUTE
(a) Conduct of transactions by plans
(1) In general
If a person desires to conduct a transaction referred to in
section 1320d-2(a)(1) of this title with a health plan as a
standard transaction -
(A) the health plan may not refuse to conduct such
transaction as a standard transaction;
(B) the insurance plan may not delay such transaction, or
otherwise adversely affect, or attempt to adversely affect, the
person or the transaction on the ground that the transaction is
a standard transaction; and
(C) the information transmitted and received in connection
with the transaction shall be in the form of standard data
elements of health information.
(2) Satisfaction of requirements
A health plan may satisfy the requirements under paragraph (1)
by -
(A) directly transmitting and receiving standard data
elements of health information; or
(B) submitting nonstandard data elements to a health care
clearinghouse for processing into standard data elements and
transmission by the health care clearinghouse, and receiving
standard data elements through the health care clearinghouse.
(3) Timetable for compliance
Paragraph (1) shall not be construed to require a health plan
to comply with any standard, implementation specification, or
modification to a standard or specification adopted or
established by the Secretary under sections 1320d-1 through 1320d-
3 of this title at any time prior to the date on which the plan
is required to comply with the standard or specification under
subsection (b) of this section.
(b) Compliance with standards
(1) Initial compliance
(A) In general
Not later than 24 months after the date on which an initial
standard or implementation specification is adopted or
established under sections 1320d-1 and 1320d-2 of this title,
each person to whom the standard or implementation
specification applies shall comply with the standard or
specification.
(B) Special rule for small health plans
In the case of a small health plan, paragraph (1) shall be
applied by substituting "36 months" for "24 months". For
purposes of this subsection, the Secretary shall determine the
plans that qualify as small health plans.
(2) Compliance with modified standards
If the Secretary adopts a modification to a standard or
implementation specification under this part, each person to whom
the standard or implementation specification applies shall comply
with the modified standard or implementation specification at
such time as the Secretary determines appropriate, taking into
account the time needed to comply due to the nature and extent of
the modification. The time determined appropriate under the
preceding sentence may not be earlier than the last day of the
180-day period beginning on the date such modification is
adopted. The Secretary may extend the time for compliance for
small health plans, if the Secretary determines that such
extension is appropriate.
(3) Construction
Nothing in this subsection shall be construed to prohibit any
person from complying with a standard or specification by -
(A) submitting nonstandard data elements to a health care
clearinghouse for processing into standard data elements and
transmission by the health care clearinghouse; or
(B) receiving standard data elements through a health care
clearinghouse.
SOURCE
(Aug. 14, 1935, ch. 531, title XI, Sec. 1175, as added Pub. L. 104-
191, title II, Sec. 262(a), Aug. 21, 1996, 110 Stat. 2027.)
EXTENSION OF DEADLINE FOR COVERED ENTITIES SUBMITTING COMPLIANCE PLANS
Pub. L. 107-105, Sec. 2, Dec. 27, 2001, 115 Stat. 1003, provided
that:
"(a) In General. -
"(1) Extension. - Subject to paragraph (2), notwithstanding
section 1175(b)(1)(A) of the Social Security Act (42 U.S.C. 1320d-
4(b)(1)(A)) and section 162.900 of title 45, Code of Federal
Regulations, a health care provider, health plan (other than a
small health plan), or a health care clearinghouse shall not be
considered to be in noncompliance with the applicable
requirements of subparts I through R of part 162 of title 45,
Code of Federal Regulations, before October 16, 2003.
"(2) Condition. - Paragraph (1) shall apply to a person
described in such paragraph only if, before October 16, 2002, the
person submits to the Secretary of Health and Human Services a
plan of how the person will come into compliance with the
requirements described in such paragraph not later than October
16, 2003. Such plan shall be a summary of the following:
"(A) An analysis reflecting the extent to which, and the
reasons why, the person is not in compliance.
"(B) A budget, schedule, work plan, and implementation
strategy for achieving compliance.
"(C) Whether the person plans to use or might use a
contractor or other vendor to assist the person in achieving
compliance.
"(D) A timeframe for testing that begins not later than April
16, 2003.
"(3) Electronic submission. - Plans described in paragraph (2)
may be submitted electronically.
"(4) Model form. - Not later than March 31, 2002, the Secretary
of Health and Human Services shall promulgate a model form that
persons may use in drafting a plan described in paragraph (2).
The promulgation of such form shall be made without regard to
chapter 35 of title 44, United States Code (commonly known as the
'Paperwork Reduction Act').
"(5) Analysis of plans; reports on solutions. -
"(A) Analysis of plans. -
"(i) Furnishing of plans. - Subject to subparagraph (D),
the Secretary of Health and Human Services shall furnish the
National Committee on Vital and Health Statistics with a
sample of the plans submitted under paragraph (2) for
analysis by such Committee.
"(ii) Analysis. - The National Committee on Vital and
Health Statistics shall analyze the sample of the plans
furnished under clause (i).
"(B) Reports on solutions. - The National Committee on Vital
and Health Statistics shall regularly publish, and widely
disseminate to the public, reports containing effective
solutions to compliance problems identified in the plans
analyzed under subparagraph (A). Such reports shall not relate
specifically to any one plan but shall be written for the
purpose of assisting the maximum number of persons to come into
compliance by addressing the most common or challenging
problems encountered by persons submitting such plans.
"(C) Consultation. - In carrying out this paragraph, the
National Committee on Vital and Health Statistics shall consult
with each organization -
"(i) described in section 1172(c)(3)(B) of the Social
Security Act (42 U.S.C. 1320d-1(c)(3)(B)); or
"(ii) designated by the Secretary of Health and Human
Services under section 162.910(a) of title 45, Code of
Federal Regulations.
"(D) Protection of confidential information. -
"(i) In general. - The Secretary of Health and Human
Services shall ensure that any material provided under
subparagraph (A) to the National Committee on Vital and
Health Statistics or any organization described in
subparagraph (C) is redacted so as to prevent the disclosure
of any -
"(I) trade secrets;
"(II) commercial or financial information that is privileged
or confidential; and
"(III) other information the disclosure of which would
constitute a clearly unwarranted invasion of personal
privacy.
"(ii) Construction. - Nothing in clause (i) shall be
construed to affect the application of section 552 of title
5, United States Code (commonly known as the 'Freedom of
Information Act'), including the exceptions from disclosure
provided under subsection (b) of such section.
"(6) Enforcement through exclusion from participation in
medicare. -
"(A) In general. - In the case of a person described in
paragraph (1) who fails to submit a plan in accordance with
paragraph (2), and who is not in compliance with the applicable
requirements of subparts I through R of part 162 of title 45,
Code of Federal Regulations, on or after October 16, 2002, the
person may be excluded at the discretion of the Secretary of
Health and Human Services from participation (including under
part C or as a contractor under sections 1816, 1842, and 1893)
[42 U.S.C. 1395h, 1395u, 1395ddd] in title XVIII of the Social
Security Act (42 U.S.C. 1395 et seq.).
"(B) Procedure. - The provisions of section 1128A of the
Social Security Act (42 U.S.C. 1320a-7a) (other than the first
and second sentences of subsection (a) and subsection (b))
shall apply to an exclusion under this paragraph in the same
manner as such provisions apply with respect to an exclusion or
proceeding under section 1128A(a) of such Act.
"(C) Construction. - The availability of an exclusion under
this paragraph shall not be construed to affect the imposition
of penalties under section 1176 of the Social Security Act (42
U.S.C. 1320d-5).
"(D) Nonapplicability to complying persons. - The exclusion
under subparagraph (A) shall not apply to a person who -
"(i) submits a plan in accordance with paragraph (2); or
"(ii) who is in compliance with the applicable requirements
of subparts I through R of part 162 of title 45, Code of
Federal Regulations, on or before October 16, 2002.
"(b) Special Rules. -
"(1) Rules of construction. - Nothing in this section shall be
construed -
"(A) as modifying the October 16, 2003, deadline for a small
health plan to comply with the requirements of subparts I
through R of part 162 of title 45, Code of Federal Regulations;
or
"(B) as modifying -
"(i) the April 14, 2003, deadline for a health care
provider, a health plan (other than a small health plan), or
a health care clearinghouse to comply with the requirements
of subpart E of part 164 of title 45, Code of Federal
Regulations; or
"(ii) the April 14, 2004, deadline for a small health plan
to comply with the requirements of such subpart.
"(2) Applicability of privacy standards before compliance
deadline for information transaction standards. -
"(A) In general. - Notwithstanding any other provision of
law, during the period that begins on April 14, 2003, and ends
on October 16, 2003, a health care provider or, subject to
subparagraph (B), a health care clearinghouse, that transmits
any health information in electronic form in connection with a
transaction described in subparagraph (C) shall comply with the
requirements of subpart E of part 164 of title 45, Code of
Federal Regulations, without regard to whether the transmission
meets the standards required by part 162 of such title.
"(B) Application to health care clearinghouses. - For
purposes of this paragraph, during the period described in
subparagraph (A), an entity that processes or facilitates the
processing of information in connection with a transaction
described in subparagraph (C) and that otherwise would be
treated as a health care clearinghouse shall be treated as a
health care clearinghouse without regard to whether the
processing or facilitation produces (or is required to produce)
standard data elements or a standard transaction as required by
part 162 of title 45, Code of Federal Regulations.
"(C) Transactions described. - The transactions described in
this subparagraph are the following:
"(i) A health care claims or equivalent encounter
information transaction.
"(ii) A health care payment and remittance advice
transaction.
"(iii) A coordination of benefits transaction.
"(iv) A health care claim status transaction.
"(v) An enrollment and disenrollment in a health plan
transaction.
"(vi) An eligibility for a health plan transaction.
"(vii) A health plan premium payments transaction.
"(viii) A referral certification and authorization
transaction.
"(c) Definitions. - In this section -
"(1) the terms 'health care provider', 'health plan', and
'health care clearinghouse' have the meaning given those terms in
section 1171 of the Social Security Act (42 U.S.C. 1320d) and
section 160.103 of title 45, Code of Federal Regulations;
"(2) the terms 'small health plan' and 'transaction' have the
meaning given those terms in section 160.103 of title 45, Code of
Federal Regulations; and
"(3) the terms 'health care claims or equivalent encounter
information transaction', 'health care payment and remittance
advice transaction', 'coordination of benefits transaction',
'health care claim status transaction', 'enrollment and
disenrollment in a health plan transaction', 'eligibility for a
health plan transaction', 'health plan premium payments
transaction', and 'referral certification and authorization
transaction' have the meanings given those terms in sections
162.1101, 162.1601, 162.1801, 162.1401, 162.1501, 162.1201,
162.1701, and 162.1301 of title 45, Code of Federal Regulations,
respectively."