Patients Access to Test Reports

The following information is representative of pending federal registered changes to HIPAA and CLIA regarding consumer patient's and diagnostic laboratory testing results. To view original text, please go here.     

[Federal Register Volume 76, Number 178 (Wednesday, September 14, 2011)]
[Proposed Rules]
[Pages 56712-56724]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23525]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 493

Office of the Secretary

45 CFR Part 164

[CMS-2319-P]
RIN 0938-AQ38


CLIA Program and HIPAA Privacy Rule; Patients' Access to Test
Reports

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS; Centers
for Disease Control and Prevention (CDC), HHS; Office for Civil Rights
(OCR), HHS.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: This proposed rule would amend the Clinical Laboratory
Improvement Amendments of 1988 (CLIA) regulations to specify that, upon
a patient's request, the laboratory may provide access to completed
test reports that, using the laboratory's authentication process, can
be identified as belonging to that patient. Subject to conforming
amendments, the proposed rule would retain the existing provisions that
provide for release of test reports to authorized persons and, if
applicable, the individuals (or their personal representative)
responsible for using the test reports and, in the case of reference
laboratories, the laboratory that initially requested the test. In
addition, this proposed rule would also amend the Health Insurance
Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to
provide individuals the right to receive their test reports directly
from laboratories by removing the exceptions for CLIA-certified
laboratories and CLIA-exempt laboratories from the provision that
provides individuals with the right of access to their protected health
information.

DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on November 14,
2011.

ADDRESSES: In commenting, please refer to file code CMS-2319-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
    You may submit comments in one of four ways (please choose only one
of the ways listed):
    1. Electronically. You may submit electronic comments on this
regulation

[[Page 56713]]

to http://www.regulations.gov. Follow the ``Submit a comment''
instructions.
    2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-2319-P, P.O. Box 8010,
Baltimore, MD 21244-8010.
    Please allow sufficient time for mailed comments to be received
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-2319-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    4. By hand or courier. Alternatively, you may deliver (by hand or
courier) your written comments ONLY to the following addresses prior to
the close of the comment period:
    a. For delivery in Washington, DC--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Room 445-G, Hubert
H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC
20201.

    (Because access to the interior of the Hubert H. Humphrey Building
is not readily available to persons without Federal government
identification, commenters are encouraged to leave their comments in
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing
by stamping in and retaining an extra copy of the comments being
filed.)
    b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850.

    If you intend to deliver your comments to the Baltimore address,
please call telephone number (410) 786-9994 in advance to schedule your
arrival with one of our staff members.
    Comments erroneously mailed to the addresses indicated as
appropriate for hand or courier delivery may be delayed and received
after the comment period.
    Submission of comments on paperwork requirements. You may submit
comments on this document's paperwork requirements by following the
instructions at the end of the ``Collection of Information
Requirements'' section in this document.
    For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: For CLIA regulations:

Nancy Anderson, CDC, (404) 498-2280.
Judith Yost, CMS, (410) 786-3531.

    For HIPAA Privacy Rule:

Andra Wicks, OCR, (202) 205-2292.

SUPPLEMENTARY INFORMATION:
    Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following Web
site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to
view public comments.
    Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
phone 1-800-743-3951.

I. Background

A. CLIA Statute and Regulations

    The Clinical Laboratory Improvement Amendments of 1988 (CLIA) were
enacted to establish quality standards for certain laboratory testing.
These standards ensure the accuracy, reliability and timeliness of
patient test results, regardless of where the test is performed. The
standards are based on the complexity of the laboratory test method;
the more complicated the test, the more stringent the requirements for
the laboratory.
    CLIA established three categories of testing based on complexity
level. In increasing order of complexity, these categories are waived
complexity, moderate complexity which includes the subcategory of
provider-performed microscopy (PPM), and high complexity. Laboratories
must hold a CLIA certificate for the most complex form of CLIA-
regulated testing that they perform.
    CLIA covers all phases of laboratory testing, including the
reporting out of test results. The CLIA-based limitations that govern
to whom a laboratory may issue a test report have become a point of
concern. The requirements for a laboratory test report are set forth in
42 CFR 493.1291.
    Under the current regulations at Sec.  493.1291(f), CLIA limits a
laboratory's disclosure of laboratory test results to three categories
of individuals: the ``authorized person,'' the person responsible for
using the test results in the treatment context, and, in the case of
reference laboratories, the referring lab. Authorized person is defined
in Sec.  493.2 as the individual authorized under State law to order or
receive test results, or both. In States that do not provide for
individual access to the individual's test results, the individual must
receive his or her results through the ordering provider.
    While individuals can obtain test results through the ordering
provider, we believe that the advent of certain health reform concepts
(for example, individualized medicine and an individual's active
involvement in his or her own health care) would be best served by
revisiting the CLIA limitations on the disclosure of laboratory test
results.
    Title XIII of Division A and Title IV of Division B of the American
Recovery and Reinvestment Act of 2009 (The Recovery Act), which was
enacted on February 17, 2009, incorporated the Health Information
Technology for Economic and Clinical Health (HITECH) Act.
    HITECH created a Federal advisory committee known as the Health
Information Technology (HIT) Policy Committee. The HIT Policy Committee
has broad representation from major health care constituencies and
provides recommendations to the Office of the National Coordinator for
Health Information Technology (ONC) on issues relating to the
implementation of an interoperable, nationwide health information
infrastructure. Among other efforts, the HIT Policy Committee has
sought to identify barriers to the adoption and use of health
information technology. According to the HIT Policy Committee, CLIA
regulations are perceived by some stakeholders as imposing barriers to
the exchange of health information. These stakeholders include large-
and medium-sized laboratories, some public health laboratories,
electronic health record (EHR) system vendors, health policy experts,
health information exchange organizations (HIOs) and healthcare
providers who believe that the individual's access to his or her own
records is impeded, preventing patients from a more active role in
their personal health care decisions.
    CLIA staff worked with the Office of the National Coordinator for
Health IT (ONC), and the CMS Office of E-Health Standards and Services
(OESS) to

[[Page 56714]]

ensure an individual's direct access to his or her own medical records
through laboratories.
    The collaborating offices believe the provision of direct patient
access to laboratory test reports would support the commitments and
goals of the Secretary of HHS and the CMS Administrator regarding the
widespread adoption of EHRs by 2014.
    Therefore, in an effort to increase direct patient access rights,
we are proposing that, upon a patient's request, CLIA regulations would
allow laboratories to provide direct patient access to completed test
reports that, using the laboratory's authentication processes, the
laboratory can identify as belonging to that patient. We propose to
retain the other categories of individuals who are eligible to receive
test reports from laboratories, namely the individuals responsible for
using the test reports, and, in the case of a reference laboratory, the
laboratory that initially requested the test. We also propose certain
conforming amendments to the existing regulations. CMS solicits
comments from stakeholders regarding the potential impact of this
change on improving patients' access to their laboratory results.

B. HIPAA Statute and Privacy Rule

    The Health Insurance Portability and Accountability Act of 1996
(HIPAA), Title II, subtitle F--Administrative Simplification, Public
Law 104-191, 110 Stat., 2021, provided for the establishment of
national standards to protect the privacy and security of personal
health information. The Administrative Simplification provisions of
HIPAA apply to three types of entities, which are known as ``covered
entities'': health care providers who conduct covered health care
transactions electronically, health plans, and health care
clearinghouses.
    A laboratory, as a health care provider, is only a covered entity
if it conducts electronic transactions (for example, electronic
submission of health care claims). The list of HIPAA transactions
applicable to providers are:
     Health care claims or equivalent encounter information.
     Coordination of benefits.
     Health care claim status.
     Eligibility for a health plan.
     Referral certification and authorization.
    If a laboratory does not conduct any of the above transactions
electronically (either because it does not conduct the transactions at
all or because it does so via paper), then it is not subject to the
HIPAA Privacy Rule. If a laboratory conducts a single transaction
electronically, then it becomes a covered entity and is subject to the
Privacy Rule with respect to all protected health information that it
creates or maintains (that is, the application of the Privacy Rule is
not limited to the individuals or records associated with an electronic
transaction).
    Pursuant to HIPAA, on December 28, 2000, the Department published a
final rule in the Federal Register (65 FR 82462) entitled ``Standards
for Privacy of Individually Identifiable Health Information, known as
the ``Privacy Rule,'' which was amended on August 14, 2002 (67 FR
53182). The Privacy Rule at 45 CFR 164.524 provides individuals with a
general right of access to inspect and obtain a copy of protected
health information about the individual in a designated record set
maintained by or for a covered entity. A ``designated record set'' is
defined at Sec.  164.501 as a group of records maintained by or for a
covered entity that is comprised of the medical records and billing
records about individuals maintained by or for a covered health care
provider; the enrollment, payment, claims adjudication, and case or
medical management record systems maintained by or for a health plan;
or used, in whole or in part, by or for the covered entity to make
decisions about individuals.
    The definition of ``designated record set'' also clarifies that the
term ``record'' means ``any item, collection, or grouping of
information that includes protected health information and is
maintained, collected, used or disseminated by or for a covered
entity.'' Laboratory test reports maintained by or for a laboratory
that is a covered entity fall within the definition of designated
record set since they are medical records about individuals.
    The right of access under Sec.  164.524 extends not only to
individuals, but also to individuals' personal representatives. The
rules governing who may act as a personal representative under the
Privacy Rule are set forth at Sec.  164.502(g).
    While individuals (and personal representatives) generally have the
right to inspect and obtain a copy of their protected health
information in a designated record set, the Privacy Rule includes a set
of exceptions related to CLIA. The right of access under Sec.  164.524
of the Privacy Rule does not apply to: protected health information
maintained by a covered entity that is--(1) Subject to CLIA to the
extent the provision of access to the individual would be prohibited by
law; or (2) exempt from CLIA.
    These exceptions at Sec.  164.524(a)(1)(iii) were included in the
Privacy Rule because the Department wanted to avoid a conflict with the
CLIA requirements that limited patient access to test reports (65 FR
82485). These exceptions only cover test reports at CLIA and CLIA-
exempt laboratories; the individual has a right to access the test
reports when held by any other type of covered entity (for example, a
hospital or treating physician).
    Because CMS is proposing to amend the CLIA regulations to allow
CLIA-certified laboratories to provide patients with direct access to
their test reports, there is no longer a need for the exceptions at
Sec.  164.524 for CLIA and CLIA-exempt laboratories. Unless these
exceptions are removed from the Privacy Rule, they would serve as a
barrier to individuals' right of access to test reports. Failure to
eliminate these barriers would be inconsistent with the CMS proposal
and the goals of HHS to improve individuals' electronic access to their
health information and have widespread adoption of EHRs by 2014.
Accordingly, HHS is proposing to remove the exceptions for CLIA and
CLIA-exempt laboratories from the right of access at Sec.  164.524.

II. Provisions of the Proposed Regulations

A. Proposed Changes to the CLIA Regulations (42 CFR 493.1291)

    This rule proposes revisions to Sec.  493.1291 to provide patients,
upon request, with direct access to their laboratory test reports. To
do so we are proposing to add Sec.  493.1291(l) to specify that, upon a
patient's request, the laboratory may provide an individual with access
to his or her completed test reports that, using the laboratory's
authentication processes, can be identified as belonging to that
patient. In using ``may,'' however, we would highlight the importance
of reading the proposed CLIA provisions in concert with the applicable
HIPAA provisions. As described in section IIB below, HIPAA generally
requires covered entities to give patients access to their records. One
exception to this general mandate is a provision that exempts entities
subject to CLIA where a law bars disclosure. If finalized, the proposed
HIPAA amendments will remove this exception, and covered entity
laboratories will be required to provide patients with access to test
reports. While a more detailed HIPAA preemption analysis is found in
section IIB below, we note that the CLIA ``may''

[[Page 56715]]

plus the HIPAA ``must'' would result in a ``must disclose'' for
laboratories that are HIPAA covered entities.
    We also note that, as proposed, the CLIA regulations would not
spell out the mechanism by which patient requests for access would be
submitted, processed, or responded to by the laboratories. In providing
this latitude, we intend to allow patients and their personal
representatives' access to patient test reports in accordance with the
requirements of the HIPAA Privacy Rule.
    Subject to conforming amendments, we propose to retain the existing
requirements at Sec.  493.1291(f) that otherwise limit the release of
test reports to authorized persons and, if applicable, the individuals
(or their personal representatives) responsible for using the test
reports and, in the case of a reference laboratory, the laboratory that
initially requested the test.

B. Proposed Changes to the Privacy Rule (45 CFR 164.524)

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

[[Page 56716]]

    We propose that, if finalized, HIPAA-covered laboratories would be
required to comply with the revised Sec.  164.524 by no later than 180
days after the effective date of the final rule. The effective date of
the final rule would be 60 days after publication in the Federal
Register, so laboratories would have a total of 240 days after
publication of the final rule to come into compliance. This compliance
period is consistent with section 1175(b)(2) of the Act, which provides
that the Department must provide covered entities with at least 180
days to come into compliance with modifications to standards under the
HIPAA Rules. This compliance period also is consistent with our
proposed changes to Sec.  160.105 found in the July 14, 2010 proposed
rule (75 FR 40868). That proposal would establish at Sec.  160.105 a
180-day compliance period for future modifications to the HIPAA Rules,
unless otherwise specifically provided.

III. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995, we are required to
provide 60-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act
of 1995 requires that we solicit comment on the following issues:
     The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
     The accuracy of our estimate of the information collection
burden.
     The quality, utility, and clarity of the information to be
collected.
     Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
    We are soliciting public comment on each of these issues for the
information collection requirements (ICRs) in the proposals for 42 CFR
493.1291.
    Except as provided in Sec.  493.1291(l), test reports must be
released only to authorized persons and, if applicable, the individuals
(or their personal representative) responsible for using the test
reports and, in the case of a reference laboratory, the laboratory that
initially requested the test. Under Sec.  493.1291(l), the laboratory
may, upon request by the patient, provide access to the patient's test
reports that the laboratory can identify as belonging to that patient.
The CLIA regulations would not require that CLIA-certified laboratories
provide this access--rather, the entities would be allowed to provide
for access. We note, however, that CLIA-certified laboratories
generally are covered entities under the HIPAA Privacy Rule. That rule
also provides for patients' access to their records. CLIA-certified
laboratories will need to ensure that their practices conform to CLIA
and HIPAA requirements.
    We have prepared the Paperwork Reduction Act and the Regulatory
Impact Analysis that represents the costs and benefits of the proposed
rule based on analysis of identified variables and data sources needed
for this proposed change. We identified known data elements (Table 1)
and made assumptions on elements where a source could not be identified
(Table 2). Our assumptions are based on internal discussions and
consultation with two reference laboratories. We request comments on
the assumptions used and analyses provided.

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


[[Page 56717]]


                     Table 2--Summary of Assumptions
------------------------------------------------------------------------
            Variable                      Low                High
------------------------------------------------------------------------
Number of test results per test   10 test results...  20 test results.
 report.
Percentage of patients            0.05%.............  0.50%.
 requesting test report.
Time required to process request  10 minutes........  30 minutes.
 for test report.
------------------------------------------------------------------------

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

         Table 3--Impact of Proposed Rule Change on Laboratories
------------------------------------------------------------------------
        Impacts laboratories             Does not impact laboratories
------------------------------------------------------------------------
                                                           Allows test
                      Allows test        Allows test       reports to
   No State law     reports only to      reports to       patient with
                        provider           patient          provider
                                                            approval
------------------------------------------------------------------------
Alabama            Arkansas           Delaware          California
Alaska             Georgia            District of       Connecticut
                                       Columbia
Arizona            Hawaii             Maryland          Florida
Colorado           Illinois           New Hampshire     Massachusetts
Guam               Kansas             New Jersey        Michigan
Idaho              Maine              Nevada            New York
Indiana            Missouri           Oregon            Virginia
Iowa               Pennsylvania       Puerto Rico       ................
Kentucky           Rhode Island       West Virginia     ................
Louisiana          Tennessee
Minnesota          Washington
Mississippi        Wisconsin
Montana            Wyoming
Nebraska
New Mexico
North Carolina
North Dakota
N. Mariana
 Islands
Ohio
Oklahoma
South Carolina
South Dakota
Texas
Utah
Vermont
Virgin Islands
------------------------------------------------------------------------

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

[[Page 56718]]



  Table 4--Number of Impacted Laboratories and Tests per Year in the 39
                     Affected States and Territories
------------------------------------------------------------------------
                                       Number of
              State                  laboratories       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 Accreditation.

    We assume that the development of the mechanisms to provide patient
access to laboratory test reports would be a one-time burden and that
each laboratory would develop its own unique policies and procedures to
address patient access or adopt mechanisms/procedures developed by
consultants or associations representing laboratories. We assume a one-
time burden of 2-9 hours to identify the applicable legal obligations
and to develop the processes and procedures for handling patient
requests for access to test reports. While we provide a range of burden
estimates in this proposed rule, for purposes of OMB review and
approval we will submit burden estimates based on 9 hours. We also
assume an hourly rate for a management level employee to be $50.06 (see
Table 1).
    The range of costs for laboratories to develop the necessary
processes and procedures for handling patient requests would be:

2 hours x $50.06 per hour = $100.12 per laboratory x 22, 671
laboratories = $2,269,821
9 hours x $50.06 per hour = $450.54 per laboratory x 22, 671
laboratories = $10,214,192

    The burden associated with responding to test report requests is
dependent upon the total number of test reports that exist in affected
laboratories, the percent of the results that would be requested and
the cost of producing these reports for those individuals who ask for
direct access.
    Laboratory test reports are commonly understood to contain multiple
test results with many laboratory tests being ordered as panels of
tests. Each laboratory may have their own unique test report panels
which may contain anywhere from 1 to 20 individual test results.
    Using a range of 10 to 20 test results in a test report, we
estimated the annual number of test reports that may be requested to
be:

6,108,678,992 tests per year/20 tests per report = 305,433,950 test
reports/year
6,108,678,992 tests per year/10 tests per report = 610,867,899 test
reports/year

    We are unaware of any data that would provide a reasonable estimate
for the number of patients who would

[[Page 56719]]

request test reports from laboratories if they are available. We are
soliciting public comments in order to better estimate the number of
patient requests a laboratory might receive. We assume a range of 1 in
2,000 patients (0.05%) to 1 in 200 patients (0.50%) would request
direct access to his or her test report.
    Using these figures the range of the number of patient requests per
year would be:

305,433,950 test reports per year x .0005 = 152,717 patient requests
per year
610,867,899 test reports per year x .005 = 3,054,339 patient requests
per year

    The processing of a patient request for a test report generally
covers steps from actual receipt of the patient's request to the
delivery of the report and documentation of the delivery. Requests for
laboratory results are usually handled by staff that is not management
level. Due to the lack of data that indicates the amount of time it
takes for staff to process a test report request, we assume a range of
10 to 30 minutes to handle a request from start to finish. We also
assume an hourly rate for a clerical level employee to be $30.09 (see
Table 1)).
    Using these figures, we calculated the range of costs to produce
one test report:

$30.09 per hour/60 minutes per hour = $0.50/minute
$0.50 per minute x 10 minutes = $5.00
$.50 per minute x 30 minutes = $15.00

We then multiplied this range by the range of the anticipated number of
patient requests to obtain a range of costs to provide the patient
requests per year:

152,717 patient requests per year x $5.00 = $763,585
3,054,339 patient request per year x $15.00 = $45,815,092

We then added the cost to develop the processes and procedures for
handling patient requests to the cost to provide the test reports to
obtain the range of the total costs to laboratories to provide patients
with his or her test report upon request in 2011:

$2,269,821 cost to develop process + $763,585 cost to provide test
reports = $3,033,405
$10,214,192 cost to develop process + $45,815,092 cost to provide test
reports = $56,029,285 annual cost (undiscounted 2010 dollars)

                                                                  Table 5--Estimated Annual Recordkeeping and Reporting Burden
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                          Hourly labor   Total labor      Total
                                                                                                               Burden per   Total annual     cost of       cost of      capital/     Total cost
             Regulation section(s)                       OMB  Control No.          Respondents    Responses     response       burden       reporting     reporting    maintenance       ($)
                                                                                                                 (hours)       (hours)         ($)           ($)       costs  ($)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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 burden based on available
information and certain assumptions. We request comments from
laboratories that currently provide direct access to test reports for
patients as to how they handle these requests (for example, through a
Web portal, fax, hard-copy, with or without fees, etc) and the extent
to which patient requests impact business operations. The Department
solicits comments additionally on best practices in the direct
provision of patients' laboratory results. We also request comment on
the burdens associated with providing electronic formats as requested
by individuals, machine readable or otherwise.
    To obtain copies of the supporting statement and any related forms
for the proposed paperwork collections referenced above, access CMS'
Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995,
or E-mail your request, including your address, phone number, OMB
number, and CMS document identifier, to Paperwork@cms.hhs.gov, or call
the Reports Clearance Office on (410) 786-1326.
    If you comment on these information collection and recordkeeping
estimates, please do either of the following:
    1. Submit your comments electronically as specified in the
ADDRESSES section of this proposed rule; or
    2. Submit your comments to the Office of Information and Regulatory
Affairs, Office of Management and Budget, Attention: CMS Desk Officer,
CMS-2319-P, Fax: (202) 395-6974; or E-mail: OIRA_submission@omb.eop.gov.

IV. Response to Comments

    Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble,
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.

V. Regulatory Impact Analysis

A. Overall Impact

    We have examined the impacts of this rule as required by Executive
Order 12866 on Regulatory Planning and Review (September 30, 1993),
Executive Order 13563 on Improving Regulation and Regulatory Review
(February 2, 2011), the Regulatory Flexibility Act (RFA) (September 19,
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act,
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22,
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4,
1999), and the Congressional Review Act (5 U.S.C. 804(2)).
    Executive Orders 13563 and 12866 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This rule has been designated a ``significant regulatory
action'' although not economically significant, under section 3(f) of
Executive Order 12866. Accordingly, the rule has been reviewed by the
Office of Management and Budget.
    Laboratories regulated under CLIA that do not currently provide
patients with an opportunity to receive, upon request, a copy of their
laboratory test report (defined in CLIA regulations at Sec.  493.1291)
would be affected by this proposed rule. According to CMS OSCAR
database accessed on July 8, 2010, there are 214,875 laboratories in
the United States that are subject to CLIA. OSCAR is a data network
maintained by CMS in cooperation with

[[Page 56720]]

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

[[Page 56721]]



 Table 6--Existing Laws in States/Territories Pertaining to Test Reports
------------------------------------------------------------------------
    HIPAA will preempt State law           Compatible with State law
------------------------------------------------------------------------
                      Allows test
   Allows test         reports to        Allows test
 reports only to      patient with       reports to       No State law
     provider      provider approval       patient
------------------------------------------------------------------------
Arkansas           California         Delaware          Alabama
Georgia            Connecticut        District of       Alaska
                                       Columbia
Hawaii             Florida            Maryland          Arizona
Illinois           Massachusetts      New Hampshire     Colorado
Kansas             Michigan           New Jersey        Guam
Maine              New York           Nevada            Idaho
Missouri           Virginia           Oregon            Indiana
Pennsylvania                          Puerto Rico       Iowa
Rhode Island                          West Virginia     Kentucky
Tennessee                                               Louisiana
Washington                                              Minnesota
Wisconsin                                               Mississippi
Wyoming                                                 Montana
                                                        Nebraska
                                                        New Mexico
                                                        North Carolina
                                                        North Dakota
                                                        N. Mariana
                                                         Islands
                                                        Ohio
                                                        Oklahoma
                                                        South Carolina
                                                        South Dakota
                                                        Texas
                                                        Utah
                                                        Vermont
                                                        Virgin Islands
------------------------------------------------------------------------

B. Anticipated Effects

    The current CLIA regulations and related laws of the States and
territories pose potential barriers to the laboratory exchange of
health care information (test reports) directly with the patient. These
proposed regulatory changes would amend Sec.  493.1291(f) and add Sec.  
493.1291(l) to the CLIA regulations and also amend Sec.  164.524 of the
Privacy Rule. These changes are being made in support of HHS' efforts
toward achieving patient-centered and health IT-enabled healthcare and
would allow patients direct access to their laboratory test reports
from a laboratory without having to go to their healthcare provider to
obtain this information.
    This proposed rule includes changes that, if finalized, would
impact laboratories in 39 States and territories (Table 3) where State
law does not permit the laboratory to provide test reports directly to
the patient. For the laboratories in the remaining 16 States and
territories where the laboratory is allowed to provide the test report
to the patient either directly or after provider approval, there is no
impact based on this proposed rule.

C. Costs

    Although data are not available to calculate the estimated costs
and benefits that would result from these proposed regulatory changes,
we are providing an analysis of the potential impact based upon
available information and certain assumptions. We assume that the costs
and benefits of the change to the HIPAA Privacy Rule would not be
separate from the costs and benefits associated with the changes to the
CLIA regulations. We request comments on how laboratories would handle
patient requests for laboratory test reports and the associated costs.
These proposed regulatory changes, if finalized, are anticipated to
have the following associated costs and benefits:
     The impacted laboratories may require additional resources
to process the patient requests for test reports and to provide the
test reports to the patients.
     Patients will benefit from having direct access to their
laboratory test results. (See section D below).
1. Quantifiable Impacts
    We assume that, if this proposed rule is finalized, laboratories
that are issued a CLIA Certificate of Registration, Certificate of
Compliance, or Certificate of Accreditation in the 39 States and
territories identified in Table 3 will be allowed to provide patients
with a copy of their test report upon request. The OSCAR database
includes 22,671 laboratories in the 39 States and territories that
would be impacted by this proposed change and the corresponding number
of annual tests in these laboratories is approximately 6.1 billion as
shown in Table 4. Data are not available for estimating the number of
test results reported per test report. However, it is common knowledge
that the majority of test reports contain multiple test results. Tests
are frequently ordered as panels of individual tests. For example,
according to 2008 CMS reimbursement data, three of the four most
frequently ordered tests in the Medicare outpatient setting are panels
of multiple individual tests, some of which may contain up to 20 tests.
As part of a medical encounter, frequently more than one panel is
ordered per patient, and a test report could contain a large number of
individual test results. Therefore, for the purposes of this analysis,
an assumed range of 10 to 20 is used to represent the average number of
test results per test report. Applying this range to the total number
of annual tests (6,108,678,992) from Table 4, the estimated number of
total annual test reports ranges from a low of 305,433,950 to a high of
610,867,899.
    There are no data available to estimate the proportion of test
reports that would be requested by patients from the laboratories
impacted by these proposed provisions once this rule is finalized. We
welcome data pertaining to the number of test reports requested from

[[Page 56722]]

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

                        Table 7--Total Estimated Annual Costs of Patient Test Report Requests (Policy Development and Processing)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                               Undiscounted  (Base year: 2010 $)       Discounted at  3 percent            Discounted at  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 some of these costs pursuant
to Sec.  164.524(c)(4) of the HIPAA Privacy Rule, which permits covered
entities to impose on the patient a reasonable, cost-based fee for
providing access to their health information, including the cost of
supplies for and labor of copying the requested information.
2. Non-Quantifiable Impacts
    The burden in this proposed rule would be primarily on laboratories
to provide the laboratory test reports when requested by the patient;
however, there may be some impacts on the healthcare provider's office.
If the patient does not know where the provider sent the test, the
provider may need to provide laboratory contact information to the
patient so they may request the test report. We assume that
notification of the laboratory name and contact information could be
provided in as little as 30 seconds; however there are no data to
confirm this and we thus request comment on the issue. We also note
that since the provider may need to provide an interpretation of the
test results, the provider may give the patient a copy of the test
report rather than referring the patient to the laboratory for the
information.

D. Benefits

    Although we cannot quantify the impact on patients, we believe that
it would be positive in light of findings from studies that focused on
patient receipt of test results from the provider. We found several
studies where greater than 90 percent of patients stated they preferred
being notified of all test results, both normal and abnormal (1.
Baldwin et al. Patient preferences for notification of normal
laboratory test results: a report from the ASIPS Collaborative. BMC Fam
Practice 2005;6:11; 2. Booker et al. Patient notification and follow-up
of abnormal test results. Arch Intern Med 1996; 327-

[[Page 56723]]

331; 3. Grimes et al. Patient preferences and physician practices for
laboratory test result notification. JABFM 2009:22:6:670-676; and 4.
Meza JP and Webster DS. Patient preferences for laboratory test result
notification. Am J Manag Care 2000; 6:1297-300). These same studies
reported, for both the healthcare provider and patient, the preferred
method for receiving normal test results was the U.S. mail and direct
phone contact from the provider was the preferred method for abnormal
test results. These preferences may have changed in the last 5 years
given the increase in the use of electronic communications. Advantages
reported in these studies for the patient having direct access to the
test report include reduced workload for the healthcare provider's
office, reduced chance of a patient not being informed of a laboratory
test result, and reduced numbers of patients who fail to seek
appropriate medical care.

E. Alternatives Considered

    The proposed changes to the CLIA regulations and the HIPAA Privacy
Rule are being proposed in support of the Department's efforts toward
achieving patient-centered health care. Several alternatives were
considered before selecting the approach in this proposed rule to
provide access to laboratory test reports upon a patient's request. One
alternative would have been to leave the regulations as written without
making any changes. However, this option would leave in place the
restrictions on patients' direct access to their laboratory test
results and would therefore impede the goal of promoting patient-
centered health care. Another alternative would have been to revise the
definition of ``authorized person'' under CLIA to specifically include
a patient as an authorized person. This alternative was not considered
feasible because the definition of ``authorized person'' in the CLIA
regulations also permits individuals to order tests, and it defers to
State law for authorization. A last alternative considered would have
been to require the laboratory to automatically provide each test
report directly to each patient rather than the permissive approach to
provide patients access to their reports upon request. However, this
alternative would have had the potential of significantly increasing
the cost for laboratories since 100 percent of the 300 million to 500
million test reports issued annually would need to be provided to the
patients. As discussed earlier in this regulatory impact analysis, we
welcome comments and the submission of data and information on the
costs and benefits of implementation of this proposed change so that we
can conduct a more robust assessment of the alternatives comparing
incremental costs and benefits for the final rule.

F. Accounting Statement and Table

    We have prepared the following accounting statement showing the
classification of the expenditures associated with the provisions of
this proposed rule.

----------------------------------------------------------------------------------------------------------------
                                                            Minimum           Maximum      Source citation (RIA,
              Category               Primary estimate      estimate          estimate         preamble, etc.)
----------------------------------------------------------------------------------------------------------------
                                                    BENEFITS
----------------------------------------------------------------------------------------------------------------
Monetized benefits.................               n/a               n/a               n/a  RIA Section C2.
Annualized qualified, but                         n/a               n/a               n/a  RIA Section C2.
 unmonetized, benefits.
(Unqualified benefits).............               n/a               n/a               n/a  RIA Section C2.
----------------------------------------------------------------------------------------------------------------
                                                      COSTS
----------------------------------------------------------------------------------------------------------------
Annualized monetized costs (2010
 $):
    2011...........................               n/a        $3,033,405       $56,029,285  RIA Sec C1 (Table 9).
    2012...........................               n/a           787,919        47,275,146  RIA Sec C1 (Table 9).
    2013...........................               n/a           810,572        48,634,307  RIA Sec C1 (Table 9).
    2014...........................               n/a           833,876        50,032,543  RIA Sec C1 (Table 9).
    2015...........................               n/a           857,850        51,470,978  RIA Sec C1 (Table 9).
Annualized qualified, but                         n/a               n/a               n/a  .....................
 unmonetized, benefits.
Qualitative (unquantified) costs...               n/a               n/a               n/a  RIA Section C2.
----------------------------------------------------------------------------------------------------------------
                                                    TRANSFERS
----------------------------------------------------------------------------------------------------------------
Annualized monetized transfers:                   n/a               n/a               n/a  .....................
 ``on budget''.
From whom to whom?                                n/a               n/a               n/a  .....................
Annualized monetized transfers:                   n/a               n/a               n/a  .....................
 ``off-budget''.
From whom to whom?                                n/a               n/a               n/a  .....................
----------------------------------------------------------------------------------------------------------------
              Category                                      Effects                        Source Citation (RIA,
                                                                                               preamble, etc.)
----------------------------------------------------------------------------------------------------------------
Effects on State, local, and/or                   n/a               n/a               n/a  RIA Sec A (Table 4).
 tribal governments.
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

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

[[Page 56724]]

information that could benefit the patient by reducing the chance of
the patient not being informed of a laboratory test result, reducing
the number of patients lost to follow-up, and benefiting health care
providers by reducing their workload in providing laboratory test
reports.
    In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.

List of Subjects

42 CFR Part 493

    Administrative practice and procedure, Grant programs--health,
Health facilities, Laboratories, Medicaid, Medicare, Penalties,
Reporting and recordkeeping requirements.

45 CFR Part 164

    Administrative practice and procedure, Computer technology,
Electronic information system, Electronic transactions, Employer
benefit plan, Health, Health care, Health facilities, Health insurance,
Health records, Hospitals, Medicaid, Medical research, Medicare,
Privacy, Reporting and recordkeeping requirements, Security.

    For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services proposes to amend 42 CFR part 493, and the
Department proposes to amend 45 CFR Subtitle A, Subchapter C, part 164,
as set forth below:

Title 42--Public Health

PART 493--LABORATORY REQUIREMENTS

    1. The authority citation for part 493 continues to read as
follows:

    Authority:  Section 353 of the Public Health Service Act, secs.
1102, 1861(e), the sentence following sections 1861(s)(11) through
1861(16) of the Social Security Act (42 U.S.C. 263a, 1302, 1395x(e),
the sentence following 1395x(s)(11) through 1395x(s)(16)).

Subpart K--Quality System for Nonwaived Testing

    2. Section 493.1291 is amended by--
    A. Revising paragraph (f).
    B. Adding a new paragraph (l).
    The revision and addition read as follows:


Sec.  493.1291  Standard: Test report.

* * * * *
    (f) Except as provided in paragraph (l) of this section, test
results must be released only to authorized persons and, if applicable,
the individuals (or their personal representative) responsible for
using the test results and the laboratory that initially requested the
test.
* * * * *
    (l) Upon a patient's request, the laboratory may provide access to
completed test reports that, using the laboratory's authentication
process, can be identified as belonging to that patient.

Title 45--Public Welfare

PART 164--SECURITY AND PRIVACY

    3. The authority citation for part 164 continues to read as
follows:

    Authority:  42 U.S.C. 1320d-1320d-8; sec. 264, Pub. Law 104-191,
110 Stat. 2033-2034 (42 U.S.C. 1320d-2 (note)); secs. 13400-13402,
Pub. Law 111-5, 123 Stat. 258-263.

    4. Section 164.524 is amended by revising paragraphs (a)(1)(i) and
(ii) and removing paragraph (a)(1)(iii) to read as follows:


Sec.  164.524  Access of individuals to protected health information.

    (a) (1) * * *
    (i) Psychotherapy notes; and
    (ii) Information compiled in reasonable anticipation of, or for use
in, a civil, criminal, or administrative action or proceeding.
* * * * *

    Dated: April 1, 2011.
Thomas R. Frieden,
Director, Centers for Disease Control and Prevention, Administrator,
Agency for Toxic Substances and Disease Registry.
    Dated: August 12, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
    Dated: September 7, 2011.
Leon Rodriguez,
Director, Office for Civil Rights.
    Dated: September 7, 2011.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. 2011-23525 Filed 9-12-11; 11:15 am]
BILLING CODE 4120-01-P
 

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