Source: http://www.docstoc.com/docs/108083776/HIPAA-FR-9-14-11
Timestamp: 2014-07-11 09:04:13
Document Index: 698267976

Matched Legal Cases: ['art 493', 'art 164', 'art 271', 'art 164', 'ART 164', 'art 164', 'art 164', 'art 493', 'art 164', 'ART 493', 'art 493', 'art 67']

HIPAA-FR-9-14-11
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 &amp; 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 &amp;
7. Executive Order 13045: Protection of
adverse human health or environmental                 Medicaid Services (CMS), HHS; Centers
effects, the rule is not subject to                   for Disease Control and Prevention
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
272 note) do not apply to this rule.                                                                          information.
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
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
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)
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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to http://www.regulations.gov. Follow                   FOR FURTHER INFORMATION CONTACT:      For                Under the current regulations at
the ‘‘Submit a comment’’ instructions.                  CLIA regulations:                                     &#167; 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 &amp;                       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                 &#167; 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 &amp; 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 &amp; 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 &amp; 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 &amp; 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
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                      &#167; 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 &#167; 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                   &#167; 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 &#167; 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                   &#167; 493.1291 to provide patients, upon
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
entity.’’ Laboratory test reports                     proposing to add &#167; 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 &#167; 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                   &#167; 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
• 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                &#167; 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 &#167; 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 &#167; 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,              (&#167; 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 &#167; 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 &#167; 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 &#167; 164.524(a)(1)(iii)(B).                other electronic copy of the individual’s             &#167; 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
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, &#167; 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              &#167; 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 &#167; 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 &#167; 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
&#167; 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 &#167; 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.
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
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
January 2010 Accessed July 15, 2010).
Laboratories impacted ...........                    22,671     Data from CLIA Online Survey Certification and Reporting database (OSCAR) database
Test results in impacted lab-                6,108,678,992      Data from OSCAR database accessed July 8, 2010.
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/
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;
ecec.t01.htm) and adjusts annually by 2.78 percent to reflect an l average increase in
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
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
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
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)
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
State                                                                                                      Number of tests
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
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 &#215; $50.06 per hour = $100.12 per                                       results.
mechanisms/procedures developed by                                                laboratory &#215; 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 &#215; $50.06 per hour = $450.54 per                                       number of test reports that may be
burden of 2–9 hours to identify the                                               laboratory &#215; 22, 671 laboratories =                                       requested to be:
applicable legal obligations and to                                               $10,214,192                                                               6,108,678,992 tests per year/20 tests per
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 &#215;
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 &#215;
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 &#215; .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 &#215; .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 &#215; 10 minutes = $5.00                                        = $3,033,405
The processing of a patient request for                               $.50 per minute &#215; 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 = $56,029,285 annual cost
the delivery of the report and                                           patient requests to obtain a range of                                        (undiscounted 2010 dollars)
Hourly labor              Total labor            Total capital/
Burden per              Total annual
OMB                                                                                                cost of                   cost of              maintenance              Total cost
Regulation section(s)                                   Respondents     Responses            response                 burden
Control No.                                                                                         reporting                 reporting                costs                    ($)
(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.
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
Reports Clearance Office on (410) 786–                                   Order 13563 on Improving Regulation                                     report (defined in CLIA regulations at
1326.                                                                    and Regulatory Review (February 2,                                      &#167; 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 &#167; 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
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
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
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
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 &#167; 493.1291(f) and add                       to the CLIA regulations. We request                   multiple test results. Tests are
&#167; 493.1291(l) to the CLIA regulations                   comments on how laboratories would                    frequently ordered as panels of
and also amend &#167; 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
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
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
&#167; 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
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.)
Monetized benefits ....................................                       n/a                    n/a                   n/a   RIA Section C2.
Annualized qualified, but unmonetized,                                        n/a                    n/a                   n/a   RIA Section C2.
(Unqualified benefits) ................................                       n/a                    n/a                   n/a   RIA Section C2.
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
Qualitative (unquantified) costs ................                             n/a                    n/a                   n/a   RIA Section C2.
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
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).
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
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
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.
&#167; 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.
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
*      *     *    *     *                             respective addresses are listed in the
For the reasons set forth in the                                                                              table below.
preamble, the Centers for Medicare &amp;                        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
Subchapter C, part 164, as set forth                                                                            and Mitigation Administration, Federal
below:                                                      Dated: August 12, 2011.
Emergency Management Agency, 500 C
Title 42—Public Health                                                                                          Street, SW., Washington, DC 20472,
Administrator, Centers for Medicare &amp;
(202) 646–4064, or (e-mail)
PART 493—LABORATORY                                                                                             luis.rodriguez1@dhs.gov.
REQUIREMENTS                                                                                                    FOR FURTHER INFORMATION CONTACT: Luis
1. The authority citation for part 493                  Director, Office for Civil Rights.
continues to read as follows:                                                                                   Management Branch, Federal Insurance
and Mitigation Administration, Federal
Authority: Section 353 of the Public                    Kathleen Sebelius,
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,
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
following 1395x(s)(11) through 1395x(s)(16)).                                                                   SUPPLEMENTARY INFORMATION: The
Subpart K—Quality System for                                                                                    (FEMA) proposes to make
Nonwaived Testing                                         DEPARTMENT OF HOMELAND
determinations of BFEs and modified
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
follows:                                                  44 CFR Part 67
BFEs, together with the floodplain
&#167; 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
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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