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					                                                    56712             Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Proposed Rules

                                                    the States, or on the distribution of                   1988) by examining the takings                        DEPARTMENT OF HEALTH AND
                                                    power and responsibilities among the                    implications of the rule in accordance                HUMAN SERVICES
                                                    various levels of government).                          with the Attorney General’s
                                                                                                            Supplemental Guidelines for the                       Centers for Medicare & Medicaid
                                                    6. Executive Order 13175: Consultation                                                                        Services
                                                    and Coordination With Indian Tribal                     Evaluation of Risk and Avoidance of
                                                    Governments                                             Unanticipated Takings issued under the
                                                                                                            executive order.                                      42 CFR Part 493
                                                       Executive Order 13175 (65 FR 67249,
                                                    November 9, 2000) does not apply to                     12. Executive Order 12898: Federal                    Office of the Secretary
                                                    this rule because it will not have tribal               Actions To Address Environmental
                                                    implications (i.e., substantial direct                  Justice in Minority Populations and Low               45 CFR Part 164
                                                    effects on one or more Indian tribes, or                Income Populations                                    [CMS–2319–P]
                                                    on the relationship between the Federal
                                                    Government and Indian tribes, or on the                    Because this rule proposes                         RIN 0938–AQ38
                                                    distribution of power and                               authorization of pre-existing State rules
                                                    responsibilities between the Federal                    and imposes no additional requirements                CLIA Program and HIPAA Privacy
                                                    Government and Indian tribes).                          beyond those imposed by State law and                 Rule; Patients’ Access to Test Reports
                                                                                                            there are no anticipated significant                  AGENCY:  Centers for Medicare &
                                                    7. Executive Order 13045: Protection of
                                                                                                            adverse human health or environmental                 Medicaid Services (CMS), HHS; Centers
                                                    Children From Environmental Health
                                                                                                            effects, the rule is not subject to                   for Disease Control and Prevention
                                                    and Safety Risks
                                                                                                            Executive Order 12898 (59 FR 7629,                    (CDC), HHS; Office for Civil Rights
                                                      This rule is not subject to Executive                 February 16, 1994).                                   (OCR), HHS.
                                                    Order 13045 (62 FR 19885, April 23,
                                                                                                            13. Congressional Review Act                          ACTION: Proposed rule.
                                                    1997), because it is not economically
                                                    significant as defined in Executive                                                                           SUMMARY:    This proposed rule would
                                                    Order 12866 and because the EPA does                      EPA will submit a report containing
                                                                                                            this rule and other information required              amend the Clinical Laboratory
                                                    not have reason to believe the                                                                                Improvement Amendments of 1988
                                                    environmental health or safety risks                    by the Congressional Review Act (5
                                                                                                                                                                  (CLIA) regulations to specify that, upon
                                                    addressed by this action present a                      U.S.C. 801 et seq.) to the U.S. Senate,
                                                                                                                                                                  a patient’s request, the laboratory may
                                                    disproportionate risk to children.                      the U.S. House of Representatives, and                provide access to completed test reports
                                                                                                            the Comptroller General of the United                 that, using the laboratory’s
                                                    8. Executive Order 13211: Actions That                  States prior to publication in the
                                                    Significantly Affect Energy Supply,                                                                           authentication process, can be identified
                                                                                                            Federal Register. A major rule cannot                 as belonging to that patient. Subject to
                                                    Distribution, or Use                                    take effect until 60 days after it is                 conforming amendments, the proposed
                                                      This rule is not subject to Executive                 published in the Federal Register. This               rule would retain the existing
                                                    Order 13211 (66 FR 28355, May 22,                       action is not a ‘‘major rule’’ as defined             provisions that provide for release of
                                                    2001), because it is not a significant                  by 5 U.S.C. 804(2).                                   test reports to authorized persons and,
                                                    regulatory action as defined in                                                                               if applicable, the individuals (or their
                                                    Executive Order 12866.                                  List of Subjects in 40 CFR Part 271
                                                                                                                                                                  personal representative) responsible for
                                                    9. National Technology Transfer                           Environmental protection,                           using the test reports and, in the case of
                                                    Advancement Act                                         Administrative practice and procedure,                reference laboratories, the laboratory
                                                                                                            Confidential business information,                    that initially requested the test. In
                                                      EPA approves State programs as long                                                                         addition, this proposed rule would also
                                                    as they meet criteria required by RCRA,                 Hazardous materials transportation,
                                                                                                            Hazardous waste, Indians—lands,                       amend the Health Insurance Portability
                                                    so it would be inconsistent with                                                                              and Accountability Act of 1996 (HIPAA)
                                                    applicable law for EPA, in its review of                Intergovernmental relations, Penalties,
                                                                                                            Reporting and recordkeeping                           Privacy Rule to provide individuals the
                                                    a State program, to require the use of                                                                        right to receive their test reports directly
                                                    any particular voluntary consensus                      requirements.
                                                                                                                                                                  from laboratories by removing the
                                                    standard in place of another standard                     Authority: This action is issued under the          exceptions for CLIA-certified
                                                    that meets requirements of RCRA. Thus,                  authority of sections 2002(a), 3006 and               laboratories and CLIA-exempt
                                                    the requirements of section 12(d) of the                7004(b) of the Solid Waste Disposal Act as            laboratories from the provision that
                                                    National Technology Transfer and                        amended, 42 U.S.C. 6912(a), 6926, 6974(b).            provides individuals with the right of
                                                    Advancement Act of 1995 (15 U.S.C.                                                                            access to their protected health
                                                                                                              Dated: August 28, 2011.
                                                    272 note) do not apply to this rule.                                                                          information.
                                                                                                            Susan Hedman,
                                                    10. Executive Order 12988                               Regional Administrator, Region 5.                     DATES: To be assured consideration,
                                                      As required by section 3 of Executive                 [FR Doc. 2011–23553 Filed 9–13–11; 8:45 am]           comments must be received at one of
                                                    Order 12988 (61 FR 4729, February 7,                    BILLING CODE 6560–50–P
                                                                                                                                                                  the addresses provided below, no later
                                                    1996), in issuing this rule, EPA has                                                                          than 5 p.m. on November 14, 2011.
                                                    taken the necessary steps to eliminate                                                                        ADDRESSES: In commenting, please refer
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                                                    drafting errors and ambiguity, minimize                                                                       to file code CMS–2319–P. Because of
                                                    potential litigation, and provide a clear                                                                     staff and resource limitations, we cannot
                                                    legal standard for affected conduct.                                                                          accept comments by facsimile (FAX)
                                                                                                                                                                  transmission.
                                                    11. Executive Order 12630: Evaluation                                                                            You may submit comments in one of
                                                    of Risk and Avoidance of Unanticipated                                                                        four ways (please choose only one of the
                                                    Takings                                                                                                       ways listed):
                                                      EPA has complied with Executive                                                                                1. Electronically. You may submit
                                                    Order 12630 (53 FR 8859, March 18,                                                                            electronic comments on this regulation


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                                                                      Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Proposed Rules                                         56713

                                                    to http://www.regulations.gov. Follow                   FOR FURTHER INFORMATION CONTACT:      For                Under the current regulations at
                                                    the ‘‘Submit a comment’’ instructions.                  CLIA regulations:                                     § 493.1291(f), CLIA limits a laboratory’s
                                                       2. By regular mail. You may mail                     Nancy Anderson, CDC, (404) 498–2280.                  disclosure of laboratory test results to
                                                    written comments to the following                       Judith Yost, CMS, (410) 786–3531.                     three categories of individuals: the
                                                    address ONLY: Centers for Medicare &                       For HIPAA Privacy Rule:                            ‘‘authorized person,’’ the person
                                                    Medicaid Services, Department of                                                                              responsible for using the test results in
                                                    Health and Human Services, Attention:                   Andra Wicks, OCR, (202) 205–2292.                     the treatment context, and, in the case
                                                    CMS–2319–P, P.O. Box 8010, Baltimore,                   SUPPLEMENTARY INFORMATION:                            of reference laboratories, the referring
                                                    MD 21244–8010.                                             Inspection of Public Comments: All                 lab. Authorized person is defined in
                                                       Please allow sufficient time for mailed              comments received before the close of                 § 493.2 as the individual authorized
                                                    comments to be received before the                      the comment period are available for                  under State law to order or receive test
                                                    close of the comment period.                            viewing by the public, including any                  results, or both. In States that do not
                                                       3. By express or overnight mail. You                 personally identifiable or confidential               provide for individual access to the
                                                    may send written comments to the                        business information that is included in              individual’s test results, the individual
                                                    following address ONLY: Centers for                     a comment. We post all comments                       must receive his or her results through
                                                    Medicare & Medicaid Services,                           received before the close of the                      the ordering provider.
                                                    Department of Health and Human                          comment period on the following Web                      While individuals can obtain test
                                                    Services, Attention: CMS–2319–P, Mail                   site as soon as possible after they have              results through the ordering provider,
                                                    Stop C4–26–05, 7500 Security                            been received: http://                                we believe that the advent of certain
                                                    Boulevard, Baltimore, MD 21244–1850.                    www.regulations.gov. Follow the search                health reform concepts (for example,
                                                       4. By hand or courier. Alternatively,                instructions on that Web site to view                 individualized medicine and an
                                                    you may deliver (by hand or courier)                    public comments.                                      individual’s active involvement in his
                                                    your written comments ONLY to the                          Comments received timely will also                 or her own health care) would be best
                                                    following addresses prior to the close of               be available for public inspection as                 served by revisiting the CLIA limitations
                                                    the comment period:                                     they are received, generally beginning                on the disclosure of laboratory test
                                                       a. For delivery in Washington, DC—                   approximately 3 weeks after publication               results.
                                                    Centers for Medicare & Medicaid                         of a document, at the headquarters of                    Title XIII of Division A and Title IV
                                                    Services, Department of Health and                      the Centers for Medicare & Medicaid                   of Division B of the American Recovery
                                                    Human Services, Room 445–G, Hubert                      Services, 7500 Security Boulevard,                    and Reinvestment Act of 2009 (The
                                                    H. Humphrey Building, 200                               Baltimore, Maryland 21244, Monday                     Recovery Act), which was enacted on
                                                    Independence Avenue, SW.,                               through Friday of each week from 8:30                 February 17, 2009, incorporated the
                                                    Washington, DC 20201.                                   a.m. to 4 p.m. To schedule an                         Health Information Technology for
                                                                                                            appointment to view public comments,                  Economic and Clinical Health (HITECH)
                                                       (Because access to the interior of the                                                                     Act.
                                                    Hubert H. Humphrey Building is not                      phone 1–800–743–3951.
                                                                                                                                                                     HITECH created a Federal advisory
                                                    readily available to persons without                    I. Background                                         committee known as the Health
                                                    Federal government identification,                                                                            Information Technology (HIT) Policy
                                                    commenters are encouraged to leave                      A. CLIA Statute and Regulations
                                                                                                                                                                  Committee. The HIT Policy Committee
                                                    their comments in the CMS drop slots                       The Clinical Laboratory Improvement                has broad representation from major
                                                    located in the main lobby of the                        Amendments of 1988 (CLIA) were                        health care constituencies and provides
                                                    building. A stamp-in clock is available                 enacted to establish quality standards                recommendations to the Office of the
                                                    for persons wishing to retain a proof of                for certain laboratory testing. These                 National Coordinator for Health
                                                    filing by stamping in and retaining an                  standards ensure the accuracy,                        Information Technology (ONC) on
                                                    extra copy of the comments being filed.)                reliability and timeliness of patient test            issues relating to the implementation of
                                                       b. For delivery in Baltimore, MD—                    results, regardless of where the test is              an interoperable, nationwide health
                                                    Centers for Medicare & Medicaid                         performed. The standards are based on                 information infrastructure. Among other
                                                    Services, Department of Health and                      the complexity of the laboratory test                 efforts, the HIT Policy Committee has
                                                    Human Services, 7500 Security                           method; the more complicated the test,                sought to identify barriers to the
                                                    Boulevard, Baltimore, MD 21244–1850.                    the more stringent the requirements for               adoption and use of health information
                                                       If you intend to deliver your                        the laboratory.                                       technology. According to the HIT Policy
                                                    comments to the Baltimore address,                         CLIA established three categories of               Committee, CLIA regulations are
                                                    please call telephone number (410) 786–                 testing based on complexity level. In                 perceived by some stakeholders as
                                                    9994 in advance to schedule your                        increasing order of complexity, these                 imposing barriers to the exchange of
                                                    arrival with one of our staff members.                  categories are waived complexity,                     health information. These stakeholders
                                                       Comments erroneously mailed to the                   moderate complexity which includes                    include large- and medium-sized
                                                    addresses indicated as appropriate for                  the subcategory of provider-performed                 laboratories, some public health
                                                    hand or courier delivery may be delayed                 microscopy (PPM), and high                            laboratories, electronic health record
                                                    and received after the comment period.                  complexity. Laboratories must hold a                  (EHR) system vendors, health policy
                                                       Submission of comments on                            CLIA certificate for the most complex                 experts, health information exchange
                                                    paperwork requirements. You may                         form of CLIA-regulated testing that they              organizations (HIOs) and healthcare
                                                    submit comments on this document’s                      perform.                                              providers who believe that the
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                                                    paperwork requirements by following                        CLIA covers all phases of laboratory               individual’s access to his or her own
                                                    the instructions at the end of the                      testing, including the reporting out of               records is impeded, preventing patients
                                                    ‘‘Collection of Information                             test results. The CLIA-based limitations              from a more active role in their personal
                                                    Requirements’’ section in this                          that govern to whom a laboratory may                  health care decisions.
                                                    document.                                               issue a test report have become a point                  CLIA staff worked with the Office of
                                                       For information on viewing public                    of concern. The requirements for a                    the National Coordinator for Health IT
                                                    comments, see the beginning of the                      laboratory test report are set forth in 42            (ONC), and the CMS Office of E–Health
                                                    SUPPLEMENTARY INFORMATION section.                      CFR 493.1291.                                         Standards and Services (OESS) to


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                                                    56714             Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Proposed Rules

                                                    ensure an individual’s direct access to                 conducts a single transaction                         would be prohibited by law; or (2)
                                                    his or her own medical records through                  electronically, then it becomes a                     exempt from CLIA.
                                                    laboratories.                                           covered entity and is subject to the                     These exceptions at
                                                       The collaborating offices believe the                Privacy Rule with respect to all                      § 164.524(a)(1)(iii) were included in the
                                                    provision of direct patient access to                   protected health information that it                  Privacy Rule because the Department
                                                    laboratory test reports would support                   creates or maintains (that is, the                    wanted to avoid a conflict with the
                                                    the commitments and goals of the                        application of the Privacy Rule is not                CLIA requirements that limited patient
                                                    Secretary of HHS and the CMS                            limited to the individuals or records                 access to test reports (65 FR 82485).
                                                    Administrator regarding the widespread                  associated with an electronic                         These exceptions only cover test reports
                                                    adoption of EHRs by 2014.                               transaction).                                         at CLIA and CLIA-exempt laboratories;
                                                       Therefore, in an effort to increase                     Pursuant to HIPAA, on December 28,                 the individual has a right to access the
                                                    direct patient access rights, we are                    2000, the Department published a final                test reports when held by any other type
                                                    proposing that, upon a patient’s request,               rule in the Federal Register (65 FR                   of covered entity (for example, a
                                                    CLIA regulations would allow                            82462) entitled ‘‘Standards for Privacy               hospital or treating physician).
                                                    laboratories to provide direct patient                  of Individually Identifiable Health                      Because CMS is proposing to amend
                                                    access to completed test reports that,                  Information, known as the ‘‘Privacy                   the CLIA regulations to allow CLIA-
                                                    using the laboratory’s authentication                   Rule,’’ which was amended on August                   certified laboratories to provide patients
                                                    processes, the laboratory can identify as               14, 2002 (67 FR 53182). The Privacy                   with direct access to their test reports,
                                                    belonging to that patient. We propose to                Rule at 45 CFR 164.524 provides                       there is no longer a need for the
                                                    retain the other categories of individuals              individuals with a general right of                   exceptions at § 164.524 for CLIA and
                                                    who are eligible to receive test reports                access to inspect and obtain a copy of                CLIA-exempt laboratories. Unless these
                                                    from laboratories, namely the                           protected health information about the                exceptions are removed from the
                                                    individuals responsible for using the                   individual in a designated record set                 Privacy Rule, they would serve as a
                                                    test reports, and, in the case of a                     maintained by or for a covered entity. A              barrier to individuals’ right of access to
                                                    reference laboratory, the laboratory that               ‘‘designated record set’’ is defined at               test reports. Failure to eliminate these
                                                    initially requested the test. We also                   § 164.501 as a group of records                       barriers would be inconsistent with the
                                                    propose certain conforming                              maintained by or for a covered entity                 CMS proposal and the goals of HHS to
                                                    amendments to the existing regulations.                 that is comprised of the medical records              improve individuals’ electronic access
                                                    CMS solicits comments from                              and billing records about individuals                 to their health information and have
                                                    stakeholders regarding the potential                    maintained by or for a covered health                 widespread adoption of EHRs by 2014.
                                                    impact of this change on improving                      care provider; the enrollment, payment,               Accordingly, HHS is proposing to
                                                    patients’ access to their laboratory                    claims adjudication, and case or                      remove the exceptions for CLIA and
                                                    results.                                                medical management record systems                     CLIA-exempt laboratories from the right
                                                                                                            maintained by or for a health plan; or                of access at § 164.524.
                                                    B. HIPAA Statute and Privacy Rule                       used, in whole or in part, by or for the
                                                       The Health Insurance Portability and                 covered entity to make decisions about                II. Provisions of the Proposed
                                                    Accountability Act of 1996 (HIPAA),                     individuals.                                          Regulations
                                                    Title II, subtitle F—Administrative                        The definition of ‘‘designated record              A. Proposed Changes to the CLIA
                                                    Simplification, Public Law 104–191,                     set’’ also clarifies that the term ‘‘record’’         Regulations (42 CFR 493.1291)
                                                    110 Stat., 2021, provided for the                       means ‘‘any item, collection, or
                                                                                                            grouping of information that includes                    This rule proposes revisions to
                                                    establishment of national standards to
                                                                                                            protected health information and is                   § 493.1291 to provide patients, upon
                                                    protect the privacy and security of
                                                                                                            maintained, collected, used or                        request, with direct access to their
                                                    personal health information. The
                                                                                                            disseminated by or for a covered                      laboratory test reports. To do so we are
                                                    Administrative Simplification
                                                                                                            entity.’’ Laboratory test reports                     proposing to add § 493.1291(l) to specify
                                                    provisions of HIPAA apply to three
                                                                                                            maintained by or for a laboratory that is             that, upon a patient’s request, the
                                                    types of entities, which are known as
                                                                                                            a covered entity fall within the                      laboratory may provide an individual
                                                    ‘‘covered entities’’: health care providers
                                                                                                            definition of designated record set since             with access to his or her completed test
                                                    who conduct covered health care
                                                                                                            they are medical records about                        reports that, using the laboratory’s
                                                    transactions electronically, health plans,
                                                                                                            individuals.                                          authentication processes, can be
                                                    and health care clearinghouses.
                                                       A laboratory, as a health care                          The right of access under § 164.524                identified as belonging to that patient.
                                                    provider, is only a covered entity if it                extends not only to individuals, but also             In using ‘‘may,’’ however, we would
                                                    conducts electronic transactions (for                   to individuals’ personal representatives.             highlight the importance of reading the
                                                    example, electronic submission of                       The rules governing who may act as a                  proposed CLIA provisions in concert
                                                    health care claims). The list of HIPAA                  personal representative under the                     with the applicable HIPAA provisions.
                                                    transactions applicable to providers are:               Privacy Rule are set forth at                         As described in section IIB below,
                                                       • Health care claims or equivalent                   § 164.502(g).                                         HIPAA generally requires covered
                                                    encounter information.                                     While individuals (and personal                    entities to give patients access to their
                                                       • Coordination of benefits.                          representatives) generally have the right             records. One exception to this general
                                                       • Health care claim status.                          to inspect and obtain a copy of their                 mandate is a provision that exempts
                                                       • Eligibility for a health plan.                     protected health information in a                     entities subject to CLIA where a law
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                                                       • Referral certification and                         designated record set, the Privacy Rule               bars disclosure. If finalized, the
                                                    authorization.                                          includes a set of exceptions related to               proposed HIPAA amendments will
                                                       If a laboratory does not conduct any                 CLIA. The right of access under                       remove this exception, and covered
                                                    of the above transactions electronically                § 164.524 of the Privacy Rule does not                entity laboratories will be required to
                                                    (either because it does not conduct the                 apply to: protected health information                provide patients with access to test
                                                    transactions at all or because it does so               maintained by a covered entity that is—               reports. While a more detailed HIPAA
                                                    via paper), then it is not subject to the               (1) Subject to CLIA to the extent the                 preemption analysis is found in section
                                                    HIPAA Privacy Rule. If a laboratory                     provision of access to the individual                 IIB below, we note that the CLIA ‘‘may’’


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                                                                      Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Proposed Rules                                           56715

                                                    plus the HIPAA ‘‘must’’ would result in                 health information, the covered entity                State law. HIPAA, at section 1178 of the
                                                    a ‘‘must disclose’’ for laboratories that               may also charge a fee for preparation of              Social Security Act (the Act), provides
                                                    are HIPAA covered entities.                             the summary or explanation. The fee                   that the administrative simplification
                                                       We also note that, as proposed, the                  may not include costs associated with                 regulations (‘‘the HIPAA Rules’’)
                                                    CLIA regulations would not spell out                    searching for and retrieving the                      preempt any contrary provisions of
                                                    the mechanism by which patient                          requested information.                                State law. A provision of State law is
                                                    requests for access would be submitted,                    On July 14, 2010, the Department                   ‘‘contrary’’ to a provision of the HIPAA
                                                    processed, or responded to by the                       issued a proposed rule to implement                   Rules if a covered entity would find it
                                                    laboratories. In providing this latitude,               most of the privacy and security                      impossible to comply with both the
                                                    we intend to allow patients and their                   provisions of the HITECH Act, which                   State and Federal requirements; or the
                                                    personal representatives’ access to                     included provisions to strengthen an                  provision of State law stands as an
                                                    patient test reports in accordance with                 individual’s right to receive an                      obstacle to the accomplishment and
                                                    the requirements of the HIPAA Privacy                   electronic copy of his or her protected               execution of the full purposes and
                                                    Rule.                                                   health information, where such                        objectives of part C of title XI of the Act
                                                       Subject to conforming amendments,                    information is maintained electronically              or section 254 of Public Law 104–191,
                                                    we propose to retain the existing                       in one or more designated record sets.                as applicable.
                                                    requirements at § 493.1291(f) that                      Specifically, the proposed rule would                    Pursuant to section 264(c)(2) of
                                                    otherwise limit the release of test                     require in such cases that the covered                HIPAA, the HIPAA Privacy Rule
                                                    reports to authorized persons and, if                   entity provide the individual with                    includes an exception from this general
                                                    applicable, the individuals (or their                   access to the electronic information in               preemption if ‘‘the provision of State
                                                    personal representatives) responsible for               the electronic form and format                        law relates to the privacy of
                                                    using the test reports and, in the case of              requested by the individual, if it is                 individually identifiable health
                                                    a reference laboratory, the laboratory                  readily producible in such form and                   information and is more stringent than
                                                    that initially requested the test.                      format, or, if not, in a readable                     a standard, requirement, or
                                                    B. Proposed Changes to the Privacy Rule                 electronic form and format as agreed to               implementation specification adopted
                                                    (45 CFR 164.524)                                        by the covered entity and the                         under subpart E of part 164 of this
                                                                                                            individual. Additionally, the                         subchapter.’’ With respect to a State law
                                                      The Department also proposes to                       Department proposed changes to                        pertaining to an individual’s right to
                                                    amend the Privacy Rule at § 164.524 to                  address and clarify the fees associated               access his or her protected health
                                                    remove the exceptions that relate to                    with the provision of electronic access.              information, a State law is more
                                                    CLIA and affect an individual’s right of                The Department proposed to allow                      stringent than the Privacy Rule if the
                                                    access. This proposal would align the                   reasonable cost-based fees reflecting the             State law ‘‘permits greater rights of
                                                    Privacy Rule with CMS’ proposed                         costs of labor for creating the electronic            access or amendment, as applicable’’
                                                    changes and the Department’s goal of                    copy of the information and of supplies,              (§ 160.202).
                                                    improving individuals’ access to their                  such as CDs, if the individual requests                  A number of States have laws that
                                                    health information.                                     that the electronic copy be provided on               prohibit a laboratory from releasing a
                                                      As a result of this proposal, HIPAA                   portable media. HIPAA covered                         test report directly to the patient or that
                                                    covered entities that are laboratories                  laboratories would be required to                     prohibit the release without the ordering
                                                    subject to CLIA would have the same                     comply with the Privacy Rule’s                        provider’s consent. If adopted, the
                                                    obligations as other types of covered                   provisions regarding form of access                   proposed changes to § 164.524 would
                                                    health care providers with respect to                   provided and fees, as they exist                      preempt any contrary State laws that
                                                    providing individuals with access to                    currently and then are ultimately                     prohibit the HIPAA-covered laboratory
                                                    their protected health information in                   modified by a final rule implementing                 from directly providing access to the
                                                    accordance with § 164.524. Similarly,                   the HITECH Act. With respect to the                   individual.
                                                    HIPAA covered entities that are CLIA-                   provision of electronic access, covered                  We note that covered entities,
                                                    exempt laboratories (as the term is                     entities that have electronic reporting               including CLIA and CLIA-exempt
                                                    defined at 42 CFR 493.2) would no                       capabilities are expected to provide the              laboratories under our proposal, must
                                                    longer be excepted from HIPAA’s right                   individual with a machine readable or                 satisfy the verification requirement of
                                                    of access under § 164.524(a)(1)(iii)(B).                other electronic copy of the individual’s             § 164.514(h) before providing an
                                                    As with other covered entities, HIPAA                   protected health information. (The                    individual with access. This
                                                    covered laboratories would be required                  individual always retains the right to                requirement is consistent with the
                                                    to provide access to the individual or                  request and receive a paper copy, if                  proposed change to the CLIA
                                                    the individual’s personal representative.               desired.) The Department considers                    requirements, which would allow a
                                                      The current HIPAA Privacy Rule                        machine readable data to mean digital                 laboratory to provide patients with
                                                    requires covered entities to provide an                 information stored in a standard format               access to test reports when the
                                                    individual with access to protected                     enabling the information to be                        laboratory can authenticate that the test
                                                    health information in the form or format                processed and analyzed by computer.                   report pertains to the patient. We
                                                    requested by the individual, if it is                   For example, this would include                       recognize that a laboratory may receive
                                                    readily producible in such form or                      providing the individual with an                      a test order with only an anonymous
                                                    format. The Privacy Rule permits                        electronic copy of the protected health               identifier and thus may be unable to
                                                    covered entities to charge a reasonable,                                                                      identify the individual who is the
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                                                                                                            information in the format of MS Word
                                                    cost-based fee to provide individuals                   or Excel, text, HTML, or text-based PDF,              subject of the test report. It is not our
                                                    with copies of their protected health                   among other formats. We request                       intent to discourage such anonymous
                                                    information. The fee may include only                   comment on the ability of laboratories to             testing. In this case, the laboratory that
                                                    the cost of copying (including supplies                 provide electronic copies of protected                receives a request for access from an
                                                    and labor) and postage, if the patient                  health information in machine readable                individual but cannot verify that the
                                                    requests that the copy be mailed. If the                or other electronic formats.                          requesting individual is the subject of a
                                                    patient has agreed to receive a summary                    Under our proposal, § 164.524 would                test report is under no obligation to
                                                    or explanation of his or her protected                  preempt any contrary provisions of                    provide access.


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                                                    56716              Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Proposed Rules

                                                      We propose that, if finalized, HIPAA-                  collection of information requirement is              § 493.1291(l), the laboratory may, upon
                                                    covered laboratories would be required                   submitted to the Office of Management                 request by the patient, provide access to
                                                    to comply with the revised § 164.524 by                  and Budget (OMB) for review and                       the patient’s test reports that the
                                                    no later than 180 days after the effective               approval. In order to fairly evaluate                 laboratory can identify as belonging to
                                                    date of the final rule. The effective date               whether an information collection                     that patient. The CLIA regulations
                                                    of the final rule would be 60 days after                 should be approved by OMB, section                    would not require that CLIA-certified
                                                    publication in the Federal Register, so                  3506(c)(2)(A) of the Paperwork                        laboratories provide this access—rather,
                                                    laboratories would have a total of 240                   Reduction Act of 1995 requires that we                the entities would be allowed to provide
                                                    days after publication of the final rule                 solicit comment on the following issues:              for access. We note, however, that CLIA-
                                                    to come into compliance. This                               • The need for the information                     certified laboratories generally are
                                                    compliance period is consistent with                     collection and its usefulness in carrying             covered entities under the HIPAA
                                                    section 1175(b)(2) of the Act, which                     out the proper functions of our agency.               Privacy Rule. That rule also provides for
                                                    provides that the Department must                           • The accuracy of our estimate of the              patients’ access to their records. CLIA-
                                                    provide covered entities with at least                   information collection burden.                        certified laboratories will need to ensure
                                                    180 days to come into compliance with                       • The quality, utility, and clarity of             that their practices conform to CLIA and
                                                    modifications to standards under the                     the information to be collected.                      HIPAA requirements.
                                                    HIPAA Rules. This compliance period                         • Recommendations to minimize the
                                                    also is consistent with our proposed                     information collection burden on the                    We have prepared the Paperwork
                                                    changes to § 160.105 found in the July                   affected public, including automated                  Reduction Act and the Regulatory
                                                    14, 2010 proposed rule (75 FR 40868).                    collection techniques.                                Impact Analysis that represents the
                                                    That proposal would establish at                            We are soliciting public comment on                costs and benefits of the proposed rule
                                                    § 160.105 a 180-day compliance period                    each of these issues for the information              based on analysis of identified variables
                                                    for future modifications to the HIPAA                    collection requirements (ICRs) in the                 and data sources needed for this
                                                    Rules, unless otherwise specifically                     proposals for 42 CFR 493.1291.                        proposed change. We identified known
                                                    provided.                                                   Except as provided in § 493.1291(l),               data elements (Table 1) and made
                                                                                                             test reports must be released only to                 assumptions on elements where a
                                                    III. Collection of Information                           authorized persons and, if applicable,                source could not be identified (Table 2).
                                                    Requirements                                             the individuals (or their personal                    Our assumptions are based on internal
                                                       Under the Paperwork Reduction Act                     representative) responsible for using the             discussions and consultation with two
                                                    of 1995, we are required to provide 60-                  test reports and, in the case of a                    reference laboratories. We request
                                                    day notice in the Federal Register and                   reference laboratory, the laboratory that             comments on the assumptions used and
                                                    solicit public comment before a                          initially requested the test. Under                   analyses provided.

                                                                                                        TABLE 1—SUMMARY OF KNOWN DATA ELEMENTS
                                                                  Variable                    Data element                                                       Source

                                                    States/territories where                                  20    Determination of this finding is based on two reports as listed here:
                                                      HIPAA will pre-empt State                                         1. Privacy and Security Solutions for Interoperable Health Information Exchange, Re-
                                                      Law.1                                                                leasing Clinical Laboratory Test Results; Report on Survey of State Laws prepared
                                                                                                                           by Joy Pritts, JD, for the Agency for Healthcare Research and Quality and Office of
                                                                                                                           the National Coordinator August 2009; RIT Project Number 0209825.000.015.100
                                                                                                                           (accessed July 15, 2010).
                                                                                                                        2. Electronic Release of Clinical Laboratory Results: A Review of State and Federal
                                                                                                                           Policy prepared by Kitty Purington, JD, for the California Healthcare Foundations
                                                                                                                           January 2010 (Accessed July 15, 2010).1)
                                                    States/territories where lab-                             39    Determination of this finding is based on two reports as listed here:
                                                      oratories are impacted.                                           1. Privacy and Security Solutions for Interoperable Health Information Exchange, Re-
                                                                                                                           leasing Clinical Laboratory Test Results; Report on Survey of State Laws prepared
                                                                                                                           by Joy Pritts, JD, for the Agency for Healthcare Research and Quality and Office of
                                                                                                                           the National Coordinator August 2009; RIT Project Number 0209825.000.015.100
                                                                                                                           (Accessed July 15, 2010).
                                                                                                                        2. Electronic Release of Clinical Laboratory Results: A Review of State and Federal
                                                                                                                           Policy prepared by Kitty Purington, JD, for the California Healthcare Foundations
                                                                                                                           January 2010 Accessed July 15, 2010).
                                                    Laboratories impacted ...........                    22,671     Data from CLIA Online Survey Certification and Reporting database (OSCAR) database
                                                                                                                      accessed July 8, 2010.
                                                    Test results in impacted lab-                6,108,678,992      Data from OSCAR database accessed July 8, 2010.
                                                      oratories.
                                                    Hourly salary of clerical level                      $30.09     2011 salary/wages and benefits—use 2010 salary/wages and benefits of $29.25 obtained
                                                      employee to process test                                        from the U.S. Bureau of Labor Statistics, Economic News Release, March 2010 U.S.—
                                                      request.                                                        Total employer costs per hour worked for employee compensation: Civilian workers;
                                                                                                                      Occupational     Group:     Service-providing  at    (http://www.bls.gov/news.release/
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                                                                                                                      ecec.t01.htm) and adjusts annually by 2.78 percent to reflect an average increase in
                                                                                                                      total compensation costs from 2005–2009.
                                                    Hourly salary of management                          $50.06     2011 salary/wages and benefits—use 2010 salary/wages and benefits of $48.66 obtained
                                                      level employee to deter-                                        from the U.S. Bureau of Labor Statistics, Economic News Release, March 2010 U.S.—
                                                      mine policy.                                                    Total employer costs per hour worked for employee compensation: Civilian workers;
                                                                                                                      Occupational     Group:     Service-providing  at    (http://www.bls.gov/news.release/
                                                                                                                      ecec.t01.htm) and adjusts annually by 2.78 percent to reflect an l average increase in
                                                                                                                      total compensation costs from 2005–2009.
                                                       1 Note   that there may be circumstances where a laboratory is able to comply with both HIPAA and the State law.



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                                                                         Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Proposed Rules                                                                       56717

                                                                                                                    TABLE 2—SUMMARY OF ASSUMPTIONS
                                                                                            Variable                                                                     Low                                                High

                                                    Number of test results per test report .....................................................   10 test results ................................      20 test results.
                                                    Percentage of patients requesting test report .........................................        0.05% .............................................   0.50%.
                                                    Time required to process request for test report ....................................          10 minutes .....................................      30 minutes.



                                                      We determined that the impacted                              means or mechanism (N = 9), and                                      proposals contained in this rulemaking.
                                                    CLIA-certified laboratories can be                             laboratories in States and territories that                          Laboratories in the remaining categories
                                                    broken down into four categories:                              allow the test reports to go to the patient                          would most likely have existing
                                                    laboratories in States and territories                         with provider approval (N = 7) (see                                  procedures in place to respond to
                                                    where there is no law regarding who can                        Table 3 for a list of states and territories                         patient requests for test reports, whereas
                                                    receive test reports (N = 26), laboratories                    by category). Of these four categories,                              the laboratories in the first two
                                                    in States and territories where test                           we believe that laboratories in the 39                               categories would most likely not have
                                                    reports can only be given to the provider                      States and territories where there is                                procedures in place and would have to
                                                    (N = 13), laboratories in States and                           either no law regarding receipt of test                              develop mechanisms for handling these
                                                    territories that allow test reports to go                      reports or where reports can only go to                              requests and providing access.
                                                    directly to the patient through some                           the provider would be affected by the

                                                                                              TABLE 3—IMPACT OF PROPOSED RULE CHANGE ON LABORATORIES
                                                                                     Impacts laboratories                                                                         Does not impact laboratories

                                                                                                          Allows test reports only to                                                                     Allows test reports to patient with
                                                                  No State law                                                                          Allows test reports to patient
                                                                                                                   provider                                                                                       provider approval

                                                    Alabama                                         Arkansas                                        Delaware                                             California
                                                    Alaska                                          Georgia                                         District of Columbia                                 Connecticut
                                                    Arizona                                         Hawaii                                          Maryland                                             Florida
                                                    Colorado                                        Illinois                                        New Hampshire                                        Massachusetts
                                                    Guam                                            Kansas                                          New Jersey                                           Michigan
                                                    Idaho                                           Maine                                           Nevada                                               New York
                                                    Indiana                                         Missouri                                        Oregon                                               Virginia
                                                    Iowa                                            Pennsylvania                                    Puerto Rico
                                                    Kentucky                                        Rhode Island                                    West Virginia
                                                    Louisiana                                       Tennessee
                                                    Minnesota                                       Washington
                                                    Mississippi                                     Wisconsin
                                                    Montana                                         Wyoming
                                                    Nebraska
                                                    New Mexico
                                                    North Carolina
                                                    North Dakota
                                                    N. Mariana Islands
                                                    Ohio
                                                    Oklahoma
                                                    South Carolina
                                                    South Dakota
                                                    Texas
                                                    Utah
                                                    Vermont
                                                    Virgin Islands



                                                      The CMS Online Survey,                                       practitioner would inform the patient of                             direct patient access to test reports.
                                                    Certification, and Reporting (OSCAR)                           those results during the visit, and we                               However, we recognize that some of
                                                    database indicates that there are a total                      anticipate that the patient would ask                                these 22,671 laboratories may not be
                                                    of 22,671 laboratories which provide                           that person with whom they interacted                                covered entities under HIPAA (because
                                                    approximately 6.1 billion tests annually                       as opposed to the laboratory, if they                                they do not conduct covered health care
                                                    (see Table 4) in the 39 States and                             have reason to seek copies of the test                               transactions electronically, for example,
                                                    territories impacted by this rule. We                          report in the future. We request public                              filing electronic claims for payment)
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                                                    assume Certificate of Waiver                                   comments on the potential impact of                                  and therefore would not be required to
                                                    laboratories and Certificate of PPM                            this rule on Certificate of Waiver and                               provide direct patient access. We do not
                                                    laboratories would not be impacted                             Certificate of PPM laboratories.
                                                                                                                                                                                        have information on the number of
                                                                                                                     If the proposals contained in this rule
                                                    because the tests are usually performed                        are finalized, most of these 22,671                                  laboratories that are not covered entities
                                                    in these sites during a patient’s visit. We                    laboratories will need to develop                                    under HIPAA and invite comment on
                                                    assume that the physician or health                            processes and procedures to provide                                  this issue.




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                                                    56718                     Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Proposed Rules

                                                      TABLE 4—NUMBER OF IMPACTED LABORATORIES AND TESTS PER YEAR IN THE 39 AFFECTED STATES AND TERRITORIES
                                                                                                                                                                                                                         Number of
                                                                                                                               State                                                                                                      Number of tests
                                                                                                                                                                                                                        laboratories

                                                    Alabama ...................................................................................................................................................                     851        243,512,093
                                                    Alaska ......................................................................................................................................................                    95          8,456,680
                                                    Arizona .....................................................................................................................................................                   563        194,894,073
                                                    Arkansas ..................................................................................................................................................                     513         66,845,370
                                                    Colorado ..................................................................................................................................................                     498        125,645,501
                                                    Georgia ....................................................................................................................................................                  1,172        194,786,593
                                                    Guam .......................................................................................................................................................                     12          2,055,709
                                                    Hawaii ......................................................................................................................................................                   124         32,566,029
                                                    Idaho ........................................................................................................................................................                  231         25,623,535
                                                    Iowa .........................................................................................................................................................                  536         75,797,879
                                                    Illinois .......................................................................................................................................................              1,077        497,900,106
                                                    Indiana .....................................................................................................................................................                   640        172,798,521
                                                    Kansas .....................................................................................................................................................                    442        239,488,953
                                                    Kentucky ..................................................................................................................................................                     697        110,373,950
                                                    Louisiana ..................................................................................................................................................                    666        119,794,280
                                                    Maine .......................................................................................................................................................                   138         32,909,637
                                                    Minnesota ................................................................................................................................................                      831        145,496,862
                                                    Missouri ....................................................................................................................................................                   665        163,380,564
                                                    N. Mariana Isl. .........................................................................................................................................                         3             88,177
                                                    Mississippi ................................................................................................................................................                    617         74,187,598
                                                    Montana ...................................................................................................................................................                     157         24,428,257
                                                    N. Carolina ...............................................................................................................................................                   1,424        288,449,078
                                                    N. Dakota .................................................................................................................................................                     139         19,783,502
                                                    Nebraska ..................................................................................................................................................                     372         64,790,081
                                                    New Mexico .............................................................................................................................................                        190         42,105,436
                                                    Ohio .........................................................................................................................................................                1,112        345,544,798
                                                    Oklahoma .................................................................................................................................................                      531        108,564,207
                                                    Pennsylvania ............................................................................................................................................                     1,095        487,529,546
                                                    Rhode Island ............................................................................................................................................                       110         35,429,909
                                                    S. Carolina ...............................................................................................................................................                     709         92,320,737
                                                    S. Dakota .................................................................................................................................................                     211        664,345,948
                                                    Tennessee ...............................................................................................................................................                     1,070        219,535,503
                                                    Texas .......................................................................................................................................................                 3,211        783,048,259
                                                    Utah .........................................................................................................................................................                  315         61,663,359
                                                    Vermont ...................................................................................................................................................                      81          9,894,769
                                                    Virgin Islands ...........................................................................................................................................                       12          1,902,023
                                                    Washington ..............................................................................................................................................                       727        176,535,389
                                                    Wisconsin .................................................................................................................................................                     748        146,846,804
                                                    Wyoming ..................................................................................................................................................                       86          9,359,277

                                                           Totals ................................................................................................................................................               22,671      6,108,678,992
                                                      Data from the CLIA OSCAR database accessed on 7/8/2010.
                                                      The ‘‘Number of tests’’ is self reported by the laboratory without validation.
                                                      Includes only moderate and high complexity laboratories issued a CLIA Certificate of Registration, Certificate of Compliance, or Certificate of
                                                    Accreditation.


                                                      We assume that the development of                                           level employee to be $50.06 (see Table                                          Laboratory test reports are commonly
                                                    the mechanisms to provide patient                                             1).                                                                           understood to contain multiple test
                                                    access to laboratory test reports would                                         The range of costs for laboratories to                                      results with many laboratory tests being
                                                    be a one-time burden and that each                                            develop the necessary processes and                                           ordered as panels of tests. Each
                                                    laboratory would develop its own                                              procedures for handling patient requests                                      laboratory may have their own unique
                                                    unique policies and procedures to                                             would be:                                                                     test report panels which may contain
                                                    address patient access or adopt                                                                                                                             anywhere from 1 to 20 individual test
                                                                                                                                  2 hours × $50.06 per hour = $100.12 per                                       results.
                                                    mechanisms/procedures developed by                                                laboratory × 22, 671 laboratories =                                         Using a range of 10 to 20 test results
                                                    consultants or associations representing                                          $2,269,821                                                                in a test report, we estimated the annual
                                                    laboratories. We assume a one-time                                            9 hours × $50.06 per hour = $450.54 per                                       number of test reports that may be
                                                    burden of 2–9 hours to identify the                                               laboratory × 22, 671 laboratories =                                       requested to be:
                                                    applicable legal obligations and to                                               $10,214,192                                                               6,108,678,992 tests per year/20 tests per
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                                                    develop the processes and procedures                                                                                                                             report = 305,433,950 test reports/
                                                    for handling patient requests for access                                        The burden associated with
                                                                                                                                  responding to test report requests is                                              year
                                                    to test reports. While we provide a range                                                                                                                   6,108,678,992 tests per year/10 tests per
                                                                                                                                  dependent upon the total number of test
                                                    of burden estimates in this proposed                                                                                                                             report = 610,867,899 test reports/
                                                                                                                                  reports that exist in affected
                                                    rule, for purposes of OMB review and                                                                                                                             year
                                                                                                                                  laboratories, the percent of the results
                                                    approval we will submit burden                                                that would be requested and the cost of                                         We are unaware of any data that
                                                    estimates based on 9 hours. We also                                           producing these reports for those                                             would provide a reasonable estimate for
                                                    assume an hourly rate for a management                                        individuals who ask for direct access.                                        the number of patients who would


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                                                                            Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Proposed Rules                                                                                                     56719

                                                    request test reports from laboratories if                                documentation of the delivery. Requests                                 costs to provide the patient requests per
                                                    they are available. We are soliciting                                    for laboratory results are usually                                      year:
                                                    public comments in order to better                                       handled by staff that is not management                                 152,717 patient requests per year ×
                                                    estimate the number of patient requests                                  level. Due to the lack of data that                                          $5.00 = $763,585
                                                    a laboratory might receive. We assume                                    indicates the amount of time it takes for                               3,054,339 patient request per year ×
                                                    a range of 1 in 2,000 patients (0.05%) to                                staff to process a test report request, we                                   $15.00 = $45,815,092
                                                    1 in 200 patients (0.50%) would request                                  assume a range of 10 to 30 minutes to                                   We then added the cost to develop the
                                                    direct access to his or her test report.                                 handle a request from start to finish. We                               processes and procedures for handling
                                                       Using these figures the range of the                                  also assume an hourly rate for a clerical                               patient requests to the cost to provide
                                                    number of patient requests per year                                      level employee to be $30.09 (see Table                                  the test reports to obtain the range of the
                                                    would be:                                                                1)).                                                                    total costs to laboratories to provide
                                                    305,433,950 test reports per year × .0005                                  Using these figures, we calculated the                                patients with his or her test report upon
                                                         = 152,717 patient requests per year                                 range of costs to produce one test report:                              request in 2011:
                                                    610,867,899 test reports per year × .005                                 $30.09 per hour/60 minutes per hour =                                   $2,269,821 cost to develop process +
                                                         = 3,054,339 patient requests per                                         $0.50/minute                                                            $763,585 cost to provide test reports
                                                         year                                                                $0.50 per minute × 10 minutes = $5.00                                        = $3,033,405
                                                       The processing of a patient request for                               $.50 per minute × 30 minutes = $15.00                                   $10,214,192 cost to develop process +
                                                    a test report generally covers steps from                                We then multiplied this range by the                                         $45,815,092 cost to provide test
                                                    actual receipt of the patient’s request to                               range of the anticipated number of                                           reports = $56,029,285 annual cost
                                                    the delivery of the report and                                           patient requests to obtain a range of                                        (undiscounted 2010 dollars)
                                                                                                TABLE 5—ESTIMATED ANNUAL RECORDKEEPING AND REPORTING BURDEN
                                                                                                                                                                                         Hourly labor              Total labor            Total capital/
                                                                                                                                                 Burden per              Total annual
                                                                                        OMB                                                                                                cost of                   cost of              maintenance              Total cost
                                                     Regulation section(s)                                   Respondents     Responses            response                 burden
                                                                                      Control No.                                                                                         reporting                 reporting                costs                    ($)
                                                                                                                                                   (hours)                 (hours)           ($)                       ($)                     ($)

                                                    42 CFR 493.1291 .......           0938–New                     22,671             22,671                        9         204,039                50.06           10,214,192                              0     10,214,192
                                                    45 CFR 493.1291 .......           0938–New                  3,054,339          3,054,339                       .5       1,527,170                30.09           45,815,092                              0     45,815,092

                                                        Total .....................   ..................        3,077,010          3,077,010    ......................      1,731,209   ......................   ......................   ......................   56,029,285



                                                      We have provided an analysis of                                        ADDRESSES         section of this proposed rule;                        Executive Order 13132 on Federalism
                                                    burden based on available information                                    or                                                                      (August 4, 1999), and the Congressional
                                                    and certain assumptions. We request                                        2. Submit your comments to the                                        Review Act (5 U.S.C. 804(2)).
                                                    comments from laboratories that                                          Office of Information and Regulatory                                       Executive Orders 13563 and 12866
                                                    currently provide direct access to test                                  Affairs, Office of Management and                                       direct agencies to assess all costs and
                                                    reports for patients as to how they                                      Budget, Attention: CMS Desk Officer,                                    benefits of available regulatory
                                                    handle these requests (for example,                                      CMS–2319–P, Fax: (202) 395–6974; or                                     alternatives and, if regulation is
                                                    through a Web portal, fax, hard-copy,                                    E-mail: OIRA_submission@omb.eop.gov.                                    necessary, to select regulatory
                                                    with or without fees, etc) and the extent                                IV. Response to Comments                                                approaches that maximize net benefits
                                                    to which patient requests impact                                                                                                                 (including potential economic,
                                                    business operations. The Department                                        Because of the large number of public                                 environmental, public health and safety
                                                    solicits comments additionally on best                                   comments we normally receive on                                         effects, distributive impacts, and
                                                    practices in the direct provision of                                     Federal Register documents, we are not                                  equity). Executive Order 13563
                                                    patients’ laboratory results. We also                                    able to acknowledge or respond to them                                  emphasizes the importance of
                                                    request comment on the burdens                                           individually. We will consider all                                      quantifying both costs and benefits, of
                                                    associated with providing electronic                                     comments we receive by the date and                                     reducing costs, of harmonizing rules,
                                                    formats as requested by individuals,                                     time specified in the DATES section of                                  and of promoting flexibility. This rule
                                                    machine readable or otherwise.                                           this preamble, and, when we proceed                                     has been designated a ‘‘significant
                                                                                                                             with a subsequent document, we will                                     regulatory action’’ although not
                                                      To obtain copies of the supporting                                     respond to the comments in the
                                                    statement and any related forms for the                                                                                                          economically significant, under section
                                                                                                                             preamble to that document.                                              3(f) of Executive Order 12866.
                                                    proposed paperwork collections
                                                    referenced above, access CMS’ Web site                                   V. Regulatory Impact Analysis                                           Accordingly, the rule has been reviewed
                                                    address at http://www.cms.hhs.gov/                                                                                                               by the Office of Management and
                                                                                                                             A. Overall Impact                                                       Budget.
                                                    PaperworkReductionActof1995, or E-
                                                    mail your request, including your                                          We have examined the impacts of this                                     Laboratories regulated under CLIA
                                                    address, phone number, OMB number,                                       rule as required by Executive Order                                     that do not currently provide patients
                                                    and CMS document identifier, to                                          12866 on Regulatory Planning and                                        with an opportunity to receive, upon
                                                                                                                             Review (September 30, 1993), Executive                                  request, a copy of their laboratory test
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                                                    Paperwork@cms.hhs.gov, or call the
                                                    Reports Clearance Office on (410) 786–                                   Order 13563 on Improving Regulation                                     report (defined in CLIA regulations at
                                                    1326.                                                                    and Regulatory Review (February 2,                                      § 493.1291) would be affected by this
                                                                                                                             2011), the Regulatory Flexibility Act                                   proposed rule. According to CMS
                                                      If you comment on these information                                    (RFA) (September 19, 1980, Pub. L. 96–                                  OSCAR database accessed on July 8,
                                                    collection and recordkeeping estimates,                                  354), section 1102(b) of the Social                                     2010, there are 214,875 laboratories in
                                                    please do either of the following:                                       Security Act, section 202 of the                                        the United States that are subject to
                                                      1. Submit your comments                                                Unfunded Mandates Reform Act of 1995                                    CLIA. OSCAR is a data network
                                                    electronically as specified in the                                       (March 22, 1995; Pub. L. 104–4),                                        maintained by CMS in cooperation with


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                                                    56720             Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Proposed Rules

                                                    the State surveying agencies and                        to HHS efforts to provide patient-                       Executive Order 13132 establishes
                                                    accrediting organizations that provides a               centered healthcare. We are unaware of                certain requirements that an agency
                                                    compilation of all the data elements                    any instances in which the changes                    must meet when it promulgates a
                                                    collected during inspection surveys                     included in this proposed rule would                  proposed rule (and subsequent final
                                                    conducted at laboratories for the                       affect health care entities operated by               rule) that imposes substantial direct
                                                    purpose of certification for participation              small government jurisdictions. We are                requirements and costs on state and
                                                    in the Medicare and Medicaid programs.                  requesting public comments in this area,              local governments, preempts State law,
                                                    Of the total CLIA-certified laboratories                particularly from laboratories in state               or otherwise has Federalism
                                                    identified in the OSCAR database, we                    health departments (including Newborn                 implications.
                                                    believe approximately 192,204, or 90                    screening), prisons, school clinics or                   The proposed changes to the CLIA
                                                    percent, of these would not be impacted                 state universities that would be                      regulations at § 493.1291 would not
                                                    by this change because they perform                     impacted, to assist us in making this                 have a substantial direct effect on State
                                                    testing either under a Certificate of                   determination in the final rule.                      and local governments, preempt State
                                                    Waiver or Certificate of Provider                                                                             law, or otherwise have a Federalism
                                                    Performed Microscopy (PPM) or they                         Section 1102(b) of the Social Security
                                                                                                            Act also requires us to prepare a                     implication and there is no change in
                                                    are located in States that already allow                                                                      the distribution of power and
                                                    the laboratory to provide patient access                regulatory impact analysis if a rule may
                                                                                                            have a significant impact on the                      responsibilities among the various
                                                    to test reports, either directly or with                                                                      levels of government. We believe that
                                                    provider approval. Removing the step in                 operations of a substantial number of
                                                                                                                                                                  this change is compatible with existing
                                                    which the provider grants permission to                 small rural hospitals. This analysis must
                                                                                                                                                                  State law for 35 States and territories as
                                                    the laboratory should not pose an                       conform to the provisions of section 603
                                                                                                                                                                  shown in Table 6. Of the 35, we believe
                                                    additional impact on the laboratory, as                 of the RFA. For purposes of section
                                                                                                                                                                  that nine already allow the laboratory to
                                                    we believe these laboratories already                   1102(b) of the Act, we define a small
                                                                                                                                                                  release test reports directly to the
                                                    have processes in place to provide                      rural hospital as a hospital that is
                                                                                                                                                                  patient. In 26 States and territories, we
                                                    patients access to test reports once that               located outside of a metropolitan
                                                                                                                                                                  believe that the licensing statutes and
                                                    permission is received.                                 statistical area and has fewer than 100
                                                                                                                                                                  regulations are silent with respect to
                                                       We expect that 22,671 laboratories                   beds. We do not expect this proposed
                                                                                                                                                                  who is authorized to receive laboratory
                                                    located in the 39 states and territories                rule would have a significant impact on
                                                                                                                                                                  test reports. If finalized, the CLIA
                                                    identified in Table 3 as having no State                small rural hospitals. The proposed rule              regulations will allow laboratories in
                                                    law or a State law that provides test                   would only apply to laboratories. If a                these States and territories to provide,
                                                    reports only to the provider would be                   small rural hospital were to operate its              upon a patient’s request, direct access to
                                                    impacted by the changes outlines in this                laboratory such that it would have to                 the patient’s identifiable test reports.
                                                    proposed rule.                                          adopt means of complying with these                      The Federalism implications of the
                                                       We believe that, if finalized, this                  proposed provisions, we anticipate that               Privacy Rule were assessed as required
                                                    proposed rule would not constitute an                   it would require minimal effort to put                by Executive Order 13132 and
                                                    economically significant rule because                   policies and procedures in place to                   published as part of the preamble to the
                                                    we estimate the range of overall annual                 respond to patient requests to the
                                                    costs that would be expended by the                                                                           final rule on December 28, 2000 (65 FR
                                                                                                            laboratory as we expect that the                      82462, 82797). Regarding preemption,
                                                    affected laboratories would be less than                cahospital would already have
                                                    $100 million for 2011.                                                                                        though the proposed changes to the
                                                                                                            procedures in place for responding to                 Privacy Rule will preempt a number of
                                                       The RFA requires agencies to analyze                 patient access requests for hospital
                                                    options for regulatory relief of small                                                                        State laws (see Table 6, below), this
                                                                                                            records under the HIPAA Privacy Rule.                 preemption of State law is consistent
                                                    entities, if a rule has a significant impact            We believe that these existing policies
                                                    on a substantial number of small                                                                              with the preemption provision of the
                                                                                                            and procedures should be easy to                      HIPAA statute. The preamble to the
                                                    entities. For purposes of the RFA, we                   translate for use in direct access
                                                    assume that the great majority of                                                                             final Privacy Rule explains that the
                                                                                                            requests to hospital-operated                         HIPAA statute dictates the relationship
                                                    medical laboratories are small entities,                laboratories. Therefore, the Secretary
                                                    either by virtue of being nonprofit                                                                           between State law and Privacy Rule
                                                                                                            has determined that this proposed rule,               requirements, and the rule’s preemption
                                                    organizations or by meeting the SBA
                                                                                                            if finalized, would not have a significant            provisions do not raise Federalism
                                                    definition of a small business by having
                                                                                                            impact on the operations of a substantial             issues.
                                                    revenues of less than $13.5 million in
                                                                                                            number of small rural hospitals.                         We do not believe that this rule would
                                                    any 1 year. We believe at least 83
                                                    percent of medical laboratories qualify                    Section 202 of the Unfunded                        impose substantial direct compliance
                                                    as small entities based on their                        Mandates Reform Act of 1995 (UMRA)                    costs on State and local governments
                                                    nonprofit status as reported in the                     also requires that agencies assess                    that are not required by statute. We do
                                                    American Hospital Association Fast                      anticipated costs and benefits before                 not believe that a significant number of
                                                    Fact Sheet updated June 24, 2010                        issuing any rule whose mandates                       laboratories affected by these proposals
                                                    (http://www.aha.org/aha/resource-                       require spending in any 1 year of $100                are operated by State or local
                                                    center/Statistics-and-Studies/Fast_                     million in 1995 dollars, updated                      governments. Therefore, the proposed
                                                    Facts_Nov_11_2009.pdf.)                                 annually for inflation. In 2011, that                 modifications in these areas would not
                                                       Other options for regulatory relief of               threshold is approximately $136                       cause additional costs to State and local
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                                                    small businesses as discussed in section                million. We do not anticipate this                    governments.
                                                    E of this proposed rule, were                           proposed rule would impose an                            In considering the principles in and
                                                    determined not to be feasible and                       unfunded mandate on states, tribal                    requirements of Executive Order 13132,
                                                    therefore these options were not                        governments, or the private sector of                 the Department has determined that this
                                                    analyzed for this proposed rule. We                     more than $136 million annually. We                   proposed modification to the Privacy
                                                    believe any alternative to allowing the                 request comments from States, tribal                  Rule will not significantly affect the
                                                    laboratory to provide patient access to                 governments, and the private sector on                rights, roles and responsibilities of the
                                                    test reports would be counterproductive                 this assumption.                                      States.


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                                                                      Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Proposed Rules                                                56721

                                                                              TABLE 6—EXISTING LAWS IN STATES/TERRITORIES PERTAINING TO TEST REPORTS
                                                                           HIPAA will preempt State law                                                         Compatible with State law

                                                                                               Allows test reports to patient with
                                                     Allows test reports only to provider                                                   Allows test reports to patient                 No State law
                                                                                                       provider approval

                                                    Arkansas                                   California                                Delaware                                Alabama
                                                    Georgia                                    Connecticut                               District of Columbia                    Alaska
                                                    Hawaii                                     Florida                                   Maryland                                Arizona
                                                    Illinois                                   Massachusetts                             New Hampshire                           Colorado
                                                    Kansas                                     Michigan                                  New Jersey                              Guam
                                                    Maine                                      New York                                  Nevada                                  Idaho
                                                    Missouri                                   Virginia                                  Oregon                                  Indiana
                                                    Pennsylvania                                                                         Puerto Rico                             Iowa
                                                    Rhode Island                                                                         West Virginia                           Kentucky
                                                    Tennessee                                                                                                                    Louisiana
                                                    Washington                                                                                                                   Minnesota
                                                    Wisconsin                                                                                                                    Mississippi
                                                    Wyoming                                                                                                                      Montana
                                                                                                                                                                                 Nebraska
                                                                                                                                                                                 New Mexico
                                                                                                                                                                                 North Carolina
                                                                                                                                                                                 North Dakota
                                                                                                                                                                                 N. Mariana Islands
                                                                                                                                                                                 Ohio
                                                                                                                                                                                 Oklahoma
                                                                                                                                                                                 South Carolina
                                                                                                                                                                                 South Dakota
                                                                                                                                                                                 Texas
                                                                                                                                                                                 Utah
                                                                                                                                                                                 Vermont
                                                                                                                                                                                 Virgin Islands



                                                    B. Anticipated Effects                                  providing an analysis of the potential                corresponding number of annual tests in
                                                       The current CLIA regulations and                     impact based upon available                           these laboratories is approximately 6.1
                                                    related laws of the States and territories              information and certain assumptions.                  billion as shown in Table 4. Data are not
                                                    pose potential barriers to the laboratory               We assume that the costs and benefits                 available for estimating the number of
                                                    exchange of health care information                     of the change to the HIPAA Privacy Rule               test results reported per test report.
                                                    (test reports) directly with the patient.               would not be separate from the costs                  However, it is common knowledge that
                                                    These proposed regulatory changes                       and benefits associated with the changes              the majority of test reports contain
                                                    would amend § 493.1291(f) and add                       to the CLIA regulations. We request                   multiple test results. Tests are
                                                    § 493.1291(l) to the CLIA regulations                   comments on how laboratories would                    frequently ordered as panels of
                                                    and also amend § 164.524 of the Privacy                 handle patient requests for laboratory                individual tests. For example, according
                                                    Rule. These changes are being made in                   test reports and the associated costs.                to 2008 CMS reimbursement data, three
                                                    support of HHS’ efforts toward                          These proposed regulatory changes, if                 of the four most frequently ordered tests
                                                    achieving patient-centered and health                   finalized, are anticipated to have the                in the Medicare outpatient setting are
                                                    IT-enabled healthcare and would allow                   following associated costs and benefits:              panels of multiple individual tests,
                                                    patients direct access to their laboratory                 • The impacted laboratories may                    some of which may contain up to 20
                                                    test reports from a laboratory without                  require additional resources to process               tests. As part of a medical encounter,
                                                    having to go to their healthcare provider               the patient requests for test reports and             frequently more than one panel is
                                                    to obtain this information.                             to provide the test reports to the                    ordered per patient, and a test report
                                                       This proposed rule includes changes                  patients.                                             could contain a large number of
                                                    that, if finalized, would impact                           • Patients will benefit from having                individual test results. Therefore, for the
                                                    laboratories in 39 States and territories               direct access to their laboratory test                purposes of this analysis, an assumed
                                                    (Table 3) where State law does not                      results. (See section D below).                       range of 10 to 20 is used to represent the
                                                    permit the laboratory to provide test                                                                         average number of test results per test
                                                                                                            1. Quantifiable Impacts                               report. Applying this range to the total
                                                    reports directly to the patient. For the
                                                    laboratories in the remaining 16 States                    We assume that, if this proposed rule              number of annual tests (6,108,678,992)
                                                    and territories where the laboratory is                 is finalized, laboratories that are issued            from Table 4, the estimated number of
                                                    allowed to provide the test report to the               a CLIA Certificate of Registration,                   total annual test reports ranges from a
                                                                                                            Certificate of Compliance, or Certificate             low of 305,433,950 to a high of
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                                                    patient either directly or after provider
                                                    approval, there is no impact based on                   of Accreditation in the 39 States and                 610,867,899.
                                                    this proposed rule.                                     territories identified in Table 3 will be                There are no data available to estimate
                                                                                                            allowed to provide patients with a copy               the proportion of test reports that would
                                                    C. Costs                                                of their test report upon request. The                be requested by patients from the
                                                      Although data are not available to                    OSCAR database includes 22,671                        laboratories impacted by these proposed
                                                    calculate the estimated costs and                       laboratories in the 39 States and                     provisions once this rule is finalized.
                                                    benefits that would result from these                   territories that would be impacted by                 We welcome data pertaining to the
                                                    proposed regulatory changes, we are                     this proposed change and the                          number of test reports requested from


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                                                    56722                  Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Proposed Rules

                                                    laboratories that are already providing                      includes estimates for a range of time for             require laboratory management staff
                                                    test reports upon request so that we                         each of the five steps listed above. The               time ranging from a low of 2 hours to
                                                    would be better able to provide a more                       time needed to complete each step is                   a high of 9 hours per laboratory. To
                                                    accurate estimate in the final rule. For                     dependent on the capabilities of the                   convert the number of hours to an
                                                    the purposes of this analysis, we assume                     laboratory, such as whether manual or                  estimated cost per laboratory, we
                                                    that many patients would still prefer to                     automated processes are available, and                 applied the rate of $50.06 (see Table 1)
                                                    obtain their laboratory result                               the desired method of communication                    to the assumed 2 to 9 hour time range
                                                    information from their healthcare                            of test reports to the individual patient              yields an estimated cost per laboratory
                                                    provider, who would also be able to                          as listed in step 5. We welcome                        ranging from $100.12 to $450.54, which
                                                    provide interpretation of the test results,                  comments based on data from                            when applied to the estimated 22,671
                                                    and thus an assumed range of from 1 in                       laboratories that already provide test                 laboratories impacted results in a total
                                                    2,000 (0.05 percent) to 1 in 200 (0.50                       reports to patients upon request. We                   estimated one-time development cost
                                                    percent) is used to represent the                            also request comment on the burdens                    ranging from $2,269,821 to $10,214,192.
                                                    proportion of test reports requested.                        associated with providing electronic
                                                    Applying this range to the number of                         formats as requested by individuals,                     Table 7 shows the total estimated
                                                    estimated annual test reports                                machine readable or otherwise.                         range of annual costs for the proposed
                                                    (305,433,950 to 610,867,899) yields an                         To determine the cost of processing                  change in undiscounted 2010 dollars
                                                    estimated annual number patient                              test reports we used an hourly rate for                and discounted at 3 percent and 7
                                                    requests ranging from 152,717 to                             a clerical level employee of $30.09 (see               percent to translate expected benefits or
                                                    3,054,339.                                                   Table 1) and determined the costs to                   costs in any given future year into
                                                       Processing a request for a test report,                   process one test report to be $5.00 if it              present value terms. To calculate the
                                                    either manually or electronically, would                     took 10 minutes and $15.00 if it took 30               total estimated costs in 2011, we added
                                                    require completion of the following                          minutes. We multiplied the range for                   the cost to develop the necessary
                                                    steps: (1) Receipt of the request from the                   the number of patient requests, 152,717                policies and processes (which would
                                                    patient; (2) authentication of the                           to 3,054,339 by $5.00 and $15.00. The                  only be applicable in the first year) and
                                                    identification of the patient; (3) retrieval                 estimated annual cost to process all test              the cost of responding to test report
                                                    of test reports; (4) verification of how                     report requests in 2011 ranges from                    requests. These costs total between $3
                                                    and where the patient wants the test                         $763,585 to $45,815,092.                               million and $56 million for 2011. As
                                                    report to be delivered and provision of                        The analysis also assumed each of the                subsequent years would only entail the
                                                    the report by mail, fax, e-mail or other                     estimated 22,671 laboratories to be                    costs associated with processing
                                                    electronic means; and (5)                                    impacted by this rule (Table 3) would                  requests, we simply took the 2011
                                                    documentation of test report issuance.                       need to develop and implement a policy                 values for the cost of responding to test
                                                    We estimated the total time to process                       and process to receive and respond to                  reports and applied the same inflation
                                                    each test report request to be in the                        patient requests as discussed above. To                factor used in Table 1 for the hourly rate
                                                    range of 10 minutes to 30 minutes. This                      estimate the initial, one-time                         calculations. The resulting values can be
                                                    estimate for a range of total time                           development cost, it is assumed to                     found in Table 7.

                                                           TABLE 7—TOTAL ESTIMATED ANNUAL COSTS OF PATIENT TEST REPORT REQUESTS (POLICY DEVELOPMENT AND
                                                                                                   PROCESSING)
                                                                                                       Undiscounted                                  Discounted at                             Discounted at
                                                                                                    (Base year: 2010 $)                                3 percent                                 7 percent

                                                                                                 Low                    High                   Low                   High                Low                   High

                                                    2011   .................................     $3,033,405            $56,029,285            $2,945,054          $54,397,364            $2,834,958        $52,363,818
                                                    2012   .................................        787,919             47,275,146               742,689           44,561,359               688,199         41,291,943
                                                    2013   .................................        810,572             48,634,307               741,788           44,507,280               661,668         39,700,081
                                                    2014   .................................        833,876             50,032,543               740,888           44,453,266               636,160         38,169,587
                                                    2015   .................................        857,850             51,470,978               739,989           44,399,318               611,635         36,698,096



                                                      Laboratories would be able to offset                       the provider may need to provide                       D. Benefits
                                                    some of these costs pursuant to                              laboratory contact information to the
                                                    § 164.524(c)(4) of the HIPAA Privacy                         patient so they may request the test                      Although we cannot quantify the
                                                    Rule, which permits covered entities to                      report. We assume that notification of                 impact on patients, we believe that it
                                                    impose on the patient a reasonable, cost-                                                                           would be positive in light of findings
                                                                                                                 the laboratory name and contact
                                                    based fee for providing access to their                                                                             from studies that focused on patient
                                                                                                                 information could be provided in as
                                                    health information, including the cost of                                                                           receipt of test results from the provider.
                                                                                                                 little as 30 seconds; however there are                We found several studies where greater
                                                    supplies for and labor of copying the                        no data to confirm this and we thus
                                                    requested information.                                                                                              than 90 percent of patients stated they
                                                                                                                 request comment on the issue. We also                  preferred being notified of all test
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                                                    2. Non-Quantifiable Impacts                                  note that since the provider may need                  results, both normal and abnormal (1.
                                                       The burden in this proposed rule                          to provide an interpretation of the test               Baldwin et al. Patient preferences for
                                                    would be primarily on laboratories to                        results, the provider may give the                     notification of normal laboratory test
                                                    provide the laboratory test reports when                     patient a copy of the test report rather               results: a report from the ASIPS
                                                    requested by the patient; however, there                     than referring the patient to the                      Collaborative. BMC Fam Practice
                                                    may be some impacts on the healthcare                        laboratory for the information.                        2005;6:11; 2. Booker et al. Patient
                                                    provider’s office. If the patient does not                                                                          notification and follow-up of abnormal
                                                    know where the provider sent the test,                                                                              test results. Arch Intern Med 1996; 327–


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                                                                           Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Proposed Rules                                                          56723

                                                    331; 3. Grimes et al. Patient preferences                           E. Alternatives Considered                             alternative considered would have been
                                                    and physician practices for laboratory                                                                                     to require the laboratory to
                                                    test result notification. JABFM                                        The proposed changes to the CLIA                    automatically provide each test report
                                                    2009:22:6:670–676; and 4. Meza JP and                               regulations and the HIPAA Privacy Rule                 directly to each patient rather than the
                                                    Webster DS. Patient preferences for                                 are being proposed in support of the                   permissive approach to provide patients
                                                    laboratory test result notification. Am J                           Department’s efforts toward achieving                  access to their reports upon request.
                                                                                                                        patient-centered health care. Several                  However, this alternative would have
                                                    Manag Care 2000; 6:1297–300). These
                                                                                                                        alternatives were considered before                    had the potential of significantly
                                                    same studies reported, for both the
                                                                                                                        selecting the approach in this proposed                increasing the cost for laboratories since
                                                    healthcare provider and patient, the
                                                                                                                        rule to provide access to laboratory test              100 percent of the 300 million to 500
                                                    preferred method for receiving normal                               reports upon a patient’s request. One
                                                    test results was the U.S. mail and direct                                                                                  million test reports issued annually
                                                                                                                        alternative would have been to leave the               would need to be provided to the
                                                    phone contact from the provider was the                             regulations as written without making                  patients. As discussed earlier in this
                                                    preferred method for abnormal test                                  any changes. However, this option                      regulatory impact analysis, we welcome
                                                    results. These preferences may have                                 would leave in place the restrictions on               comments and the submission of data
                                                    changed in the last 5 years given the                               patients’ direct access to their laboratory            and information on the costs and
                                                    increase in the use of electronic                                   test results and would therefore impede                benefits of implementation of this
                                                    communications. Advantages reported                                 the goal of promoting patient-centered                 proposed change so that we can conduct
                                                    in these studies for the patient having                             health care. Another alternative would                 a more robust assessment of the
                                                    direct access to the test report include                            have been to revise the definition of                  alternatives comparing incremental
                                                    reduced workload for the healthcare                                 ‘‘authorized person’’ under CLIA to                    costs and benefits for the final rule.
                                                    provider’s office, reduced chance of a                              specifically include a patient as an
                                                    patient not being informed of a                                     authorized person. This alternative was                F. Accounting Statement and Table
                                                    laboratory test result, and reduced                                 not considered feasible because the                      We have prepared the following
                                                    numbers of patients who fail to seek                                definition of ‘‘authorized person’’ in the             accounting statement showing the
                                                    appropriate medical care.                                           CLIA regulations also permits                          classification of the expenditures
                                                                                                                        individuals to order tests, and it defers              associated with the provisions of this
                                                                                                                        to State law for authorization. A last                 proposed rule.

                                                                                                                                             Minimum                Maximum                         Source citation
                                                                           Category                                Primary estimate          estimate               estimate                     (RIA, preamble, etc.)

                                                                                                                                            BENEFITS

                                                    Monetized benefits ....................................                       n/a                    n/a                   n/a   RIA Section C2.
                                                    Annualized qualified, but unmonetized,                                        n/a                    n/a                   n/a   RIA Section C2.
                                                      benefits.
                                                    (Unqualified benefits) ................................                       n/a                    n/a                   n/a   RIA Section C2.

                                                                                                                                              COSTS

                                                    Annualized monetized costs (2010 $):
                                                        2011 ...................................................                  n/a           $3,033,405           $56,029,285     RIA   Sec   C1   (Table   9).
                                                        2012 ...................................................                  n/a              787,919            47,275,146     RIA   Sec   C1   (Table   9).
                                                        2013 ...................................................                  n/a              810,572            48,634,307     RIA   Sec   C1   (Table   9).
                                                        2014 ...................................................                  n/a              833,876            50,032,543     RIA   Sec   C1   (Table   9).
                                                        2015 ...................................................                  n/a              857,850            51,470,978     RIA   Sec   C1   (Table   9).
                                                    Annualized qualified, but unmonetized,                                        n/a                   n/a                  n/a
                                                      benefits.
                                                    Qualitative (unquantified) costs ................                             n/a                    n/a                   n/a   RIA Section C2.

                                                                                                                                           TRANSFERS

                                                    Annualized         monetized         transfers:        ‘‘on                   n/a                    n/a                   n/a
                                                      budget’’.
                                                    From whom         to whom?                                                    n/a                    n/a                   n/a
                                                    Annualized         monetized         transfers:      ‘‘off-                   n/a                    n/a                   n/a
                                                      budget’’.
                                                    From whom         to whom?                                                    n/a                    n/a                   n/a

                                                                           Category                                                            Effects                                 Source Citation (RIA, preamble, etc.)

                                                    Effects on State, local, and/or tribal gov-                                   n/a                    n/a                   n/a   RIA Sec A (Table 4).
                                                      ernments.
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                                                    Effects on small businesses .....................                             n/a                    n/a                   n/a   RIA Section A.
                                                    Effects on wages ......................................                       n/a                    n/a                   n/a
                                                    Effects on growth ......................................                      n/a                    n/a                   n/a



                                                    G. Conclusion                                                       test reports upon request and                          costs would diminish in subsequent
                                                      We estimated the cost to laboratories                             determined it would cost between $3                    years. In addition laboratory provision
                                                    to provide patients with a copy of their                            million and $56 million in 2011. These                 of test reports to patients may provide


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                                                    56724               Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Proposed Rules

                                                    information that could benefit the                        using the test results and the laboratory             ACTION:   Proposed rule.
                                                    patient by reducing the chance of the                     that initially requested the test.
                                                    patient not being informed of a                                                                                 SUMMARY:    Comments are requested on
                                                                                                              *     *      *    *     *                             the proposed Base (1% annual-chance)
                                                    laboratory test result, reducing the                        (l) Upon a patient’s request, the
                                                    number of patients lost to follow-up,                                                                           Flood Elevations (BFEs) and proposed
                                                                                                              laboratory may provide access to
                                                    and benefiting health care providers by                                                                         BFE modifications for the communities
                                                                                                              completed test reports that, using the
                                                    reducing their workload in providing                                                                            listed in the table below. The purpose
                                                                                                              laboratory’s authentication process, can
                                                    laboratory test reports.                                                                                        of this proposed rule is to seek general
                                                                                                              be identified as belonging to that
                                                      In accordance with the provisions of                                                                          information and comment regarding the
                                                                                                              patient.
                                                    Executive Order 12866, this regulation                                                                          proposed regulatory flood elevations for
                                                    was reviewed by the Office of                             Title 45—Public Welfare                               the reach described by the downstream
                                                    Management and Budget.                                                                                          and upstream locations in the table
                                                                                                              PART 164—SECURITY AND PRIVACY                         below. The BFEs and modified BFEs are
                                                    List of Subjects                                            3. The authority citation for part 164              a part of the floodplain management
                                                                                                              continues to read as follows:                         measures that the community is
                                                    42 CFR Part 493
                                                                                                                                                                    required either to adopt or to show
                                                      Administrative practice and                               Authority: 42 U.S.C. 1320d–1320d–8; sec.            evidence of having in effect in order to
                                                    procedure, Grant programs—health,                         264, Pub. Law 104–191, 110 Stat. 2033–2034
                                                                                                              (42 U.S.C. 1320d–2 (note)); secs. 13400–
                                                                                                                                                                    qualify or remain qualified for
                                                    Health facilities, Laboratories, Medicaid,                13402, Pub. Law 111–5, 123 Stat. 258–263.             participation in the National Flood
                                                    Medicare, Penalties, Reporting and                                                                              Insurance Program (NFIP). In addition,
                                                    recordkeeping requirements.                                 4. Section 164.524 is amended by                    these elevations, once finalized, will be
                                                                                                              revising paragraphs (a)(1)(i) and (ii) and            used by insurance agents and others to
                                                    45 CFR Part 164                                           removing paragraph (a)(1)(iii) to read as             calculate appropriate flood insurance
                                                      Administrative practice and                             follows:                                              premium rates for new buildings and
                                                    procedure, Computer technology,                                                                                 the contents in those buildings.
                                                                                                              § 164.524 Access of individuals to
                                                    Electronic information system,                            protected health information.                         DATES: Comments are to be submitted
                                                    Electronic transactions, Employer                                                                               on or before December 13, 2011.
                                                                                                                (a) (1) * * *
                                                    benefit plan, Health, Health care, Health                   (i) Psychotherapy notes; and                        ADDRESSES: The corresponding
                                                    facilities, Health insurance, Health                        (ii) Information compiled in                        preliminary Flood Insurance Rate Map
                                                    records, Hospitals, Medicaid, Medical                     reasonable anticipation of, or for use in,            (FIRM) for the proposed BFEs for each
                                                    research, Medicare, Privacy, Reporting                    a civil, criminal, or administrative                  community is available for inspection at
                                                    and recordkeeping requirements,                           action or proceeding.                                 the community’s map repository. The
                                                    Security.
                                                                                                              *      *     *    *     *                             respective addresses are listed in the
                                                      For the reasons set forth in the                                                                              table below.
                                                    preamble, the Centers for Medicare &                        Dated: April 1, 2011.
                                                                                                                                                                       You may submit comments, identified
                                                    Medicaid Services proposes to amend                       Thomas R. Frieden,
                                                                                                                                                                    by Docket No. FEMA–B–1214, to Luis
                                                    42 CFR part 493, and the Department                       Director, Centers for Disease Control and
                                                                                                              Prevention, Administrator, Agency for Toxic
                                                                                                                                                                    Rodriguez, Chief, Engineering
                                                    proposes to amend 45 CFR Subtitle A,                                                                            Management Branch, Federal Insurance
                                                                                                              Substances and Disease Registry.
                                                    Subchapter C, part 164, as set forth                                                                            and Mitigation Administration, Federal
                                                    below:                                                      Dated: August 12, 2011.
                                                                                                                                                                    Emergency Management Agency, 500 C
                                                                                                              Donald M. Berwick,
                                                    Title 42—Public Health                                                                                          Street, SW., Washington, DC 20472,
                                                                                                              Administrator, Centers for Medicare &
                                                                                                                                                                    (202) 646–4064, or (e-mail)
                                                                                                              Medicaid Services.
                                                    PART 493—LABORATORY                                                                                             luis.rodriguez1@dhs.gov.
                                                                                                                Dated: September 7, 2011.
                                                    REQUIREMENTS                                                                                                    FOR FURTHER INFORMATION CONTACT: Luis
                                                                                                              Leon Rodriguez,
                                                      1. The authority citation for part 493                  Director, Office for Civil Rights.
                                                                                                                                                                    Rodriguez, Chief, Engineering
                                                    continues to read as follows:                                                                                   Management Branch, Federal Insurance
                                                                                                                Dated: September 7, 2011.
                                                                                                                                                                    and Mitigation Administration, Federal
                                                      Authority: Section 353 of the Public                    Kathleen Sebelius,
                                                                                                                                                                    Emergency Management Agency, 500 C
                                                    Health Service Act, secs. 1102, 1861(e), the              Secretary, Department of Health and Human
                                                    sentence following sections 1861(s)(11)
                                                                                                                                                                    Street, SW., Washington, DC 20472,
                                                                                                              Services.
                                                    through 1861(16) of the Social Security Act                                                                     (202) 646–4064, or (e-mail)
                                                                                                              [FR Doc. 2011–23525 Filed 9–12–11; 11:15 am]          luis.rodriguez1@dhs.gov.
                                                    (42 U.S.C. 263a, 1302, 1395x(e), the sentence
                                                                                                              BILLING CODE 4120–01–P
                                                    following 1395x(s)(11) through 1395x(s)(16)).                                                                   SUPPLEMENTARY INFORMATION: The
                                                                                                                                                                    Federal Emergency Management Agency
                                                    Subpart K—Quality System for                                                                                    (FEMA) proposes to make
                                                    Nonwaived Testing                                         DEPARTMENT OF HOMELAND
                                                                                                                                                                    determinations of BFEs and modified
                                                                                                              SECURITY
                                                      2. Section 493.1291 is amended by—                                                                            BFEs for each community listed below,
                                                      A. Revising paragraph (f).                              Federal Emergency Management                          in accordance with section 110 of the
                                                      B. Adding a new paragraph (l).                          Agency                                                Flood Disaster Protection Act of 1973,
                                                      The revision and addition read as                                                                             42 U.S.C. 4104, and 44 CFR 67.4(a).
                                                                                                                                                                       These proposed BFEs and modified
mstockstill on DSK4VPTVN1PROD with PROPOSALS




                                                    follows:                                                  44 CFR Part 67
                                                                                                                                                                    BFEs, together with the floodplain
                                                    § 493.1291       Standard: Test report.                   Docket ID FEMA–2011–0002; Internal                    management criteria required by 44 CFR
                                                    *      *    *      *     *                                Agency Docket No. FEMA–B–1214]                        60.3, are the minimum that are required.
                                                       (f) Except as provided in paragraph (l)                                                                      They should not be construed to mean
                                                                                                              Proposed Flood Elevation
                                                    of this section, test results must be                                                                           that the community must change any
                                                                                                              Determinations
                                                    released only to authorized persons and,                                                                        existing ordinances that are more
                                                    if applicable, the individuals (or their                  AGENCY:Federal Emergency                              stringent in their floodplain
                                                    personal representative) responsible for                  Management Agency, DHS.                               management requirements. The


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