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."
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