[Federal Register Volume 83, Number 240 (Friday, December 14, 2018)]
[Proposed Rules]
[Pages 64302-64310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27162]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Docket No.: HHS-OCR-0945-AA00]

45 CFR Parts 160 and 164

RIN 0945-AA00


Request for Information on Modifying HIPAA Rules To Improve 
Coordinated Care

AGENCY: Office for Civil Rights (OCR), HHS.

ACTION: Request for information.

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SUMMARY: The Office for Civil Rights (OCR) is issuing this Request for 
Information (RFI) to assist OCR in identifying provisions of the Health 
Insurance Portability and Accountability Act privacy and security 
regulations that may impede the transformation to value-based health 
care or that limit or discourage coordinated care among individuals and 
covered entities (including hospitals, physicians, and other providers, 
payors, and insurers), without meaningfully contributing to the 
protection of the privacy or security of individuals' protected health 
information. This RFI requests information on whether and how the rules 
could be revised to promote these goals, while preserving and 
protecting the privacy and security of such information and 
individuals' rights with respect to it.

DATES: Comments must be submitted on or before February 12, 2019.

ADDRESSES: You may send comments, identified by RIN 0945-AA00 or Docket 
HHS-OCR-0945-AA00, by any of the following methods:
    <bullet> Federal eRulemaking Portal. You may submit electronic 
comments at http://www.regulations.gov by searching for the Docket ID 
number HHS-OCR-0945-AA00. Follow the instructions for sending comments.
    <bullet> Hand-Delivery or Regular, Express, or Overnight Mail: U.S. 
Department of Health and Human Services, Office for Civil Rights, 
Attention: RFI, RIN 0945-AA00, Hubert H. Humphrey Building, Room 509F, 
200 Independence Avenue SW, Washington, DC 20201.
    Instructions: All submissions received must include ``Department of 
Health and Human Services, Office for Civil Rights RIN 0945-AA00'' for 
this RFI. All comments received will be posted without change to http://www.regulations.gov, including any personal information provided. 
Further instructions are available under PUBLIC PARTICIPATION.
    Docket: For complete access to the docket to read background 
documents or comments received, go to http://www.regulations.gov and 
search for Docket ID number HHS-OCR-09454-AA00.

FOR FURTHER INFORMATION CONTACT: Marie Meszaros at (800) 368-1019 or 
(800) 537-7697 (TDD).

SUPPLEMENTARY INFORMATION:

I. Background

    This RFI seeks public input on the regulations issued pursuant to 
the Health Insurance Portability and Accountability Act of 1996 (HIPAA) 
\1\ and modified pursuant to, among other laws, the Health Information 
Technology for Economic and Clinical Health (HITECH) Act of 2009.\2\ 
The HIPAA Privacy and Security Rules protect individuals' medical 
records and other individually identifiable health information created 
or received by or on behalf of covered entities, known as ``protected 
health information'' (PHI).\3\ The Privacy and Security Rules limit the 
circumstances under which covered entities may use and disclose PHI and 
require covered entities to implement safeguards to protect the privacy 
and security of PHI. The Privacy Rule also gives individuals rights 
with respect to their PHI, including the right to access their PHI and 
to receive adequate notice of a covered entity's privacy practices. In 
addition, the HIPAA Breach Notification Rule requires HIPAA covered 
entities to provide notification following a breach of unsecured PHI to 
individuals and OCR (and, in some instances, the media) and requires 
business associates to notify the relevant covered entities of such 
breaches.\4\ In this RFI, the Privacy, Security, and Breach 
Notification Rules will be referenced collectively as the HIPAA Rules.
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    \1\ See the Administrative Simplification provisions of title 
II, subtitle F, of the HIPAA (Pub. L. 104-191), which added a new 
part C to title XI of the Social Security Act (sections 1171-1179 of 
the Social Security Act, 42 U.S.C. 1320d-1320d-8) and included 
section 264, under which HHS has adopted the HIPAA Privacy Rule.
    \2\ The HITECH Act was enacted as title XIII of division A and 
title IV of division B of the American Recovery and Reinvestment Act 
of 2009 (ARRA) (Pub. L. 111-5).
    \3\ See the HIPAA Privacy and Security Rules at 45 CFR part 160 
and Subparts A, C, and E of part 164.
    \4\ See 45 CFR part 160 and part 164, Subparts A and D.
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    OCR seeks public input on ways to modify the HIPAA Rules to remove 
regulatory obstacles and decrease regulatory burdens in order to 
facilitate efficient care coordination and/or case management and to 
promote the transformation to value-based health care, while preserving 
the privacy and security of PHI. Specifically, OCR seeks information on 
the provisions of the HIPAA Rules that may present obstacles to, or 
place unnecessary burdens on, the ability of covered entities and 
business associates to conduct care coordination and/or case 
management, or that may inhibit the transformation of the health care 
system to a value-based health care system. Correspondingly, OCR seeks 
comment on modifications to the HIPAA Rules that would facilitate 
efficient care coordination and/or case management, and/or promote the 
transformation to value-based health care. OCR also broadly requests 
information and perspectives from regulated entities and the public 
about covered entities' and business associates' technical 
capabilities, individuals' interests, and ways to achieve these goals.
    In addition, OCR seeks comment on aspects of the Privacy Rule that 
OCR has identified for potential modification to further these goals, 
specifically:
    <bullet> Promoting information sharing for treatment and care 
coordination and/or case management by amending the Privacy Rule to 
encourage, incentivize,

[[Page 64303]]

or require covered entities to disclose PHI to other covered entities.
    <bullet> Encouraging covered entities, particularly providers, to 
share treatment information with parents, loved ones, and caregivers of 
adults facing health emergencies, with a particular focus on the opioid 
crisis.
    <bullet> Implementing the HITECH Act requirement to include, in an 
accounting of disclosures, disclosures for treatment, payment, and 
health care operations (TPO) from an electronic health record (EHR) in 
a manner that provides helpful information to individuals, while 
minimizing regulatory burdens and disincentives to the adoption and use 
of interoperable EHRs.
    <bullet> Eliminating or modifying the requirement for covered 
health care providers to make a good faith effort to obtain 
individuals' written acknowledgment of receipt of providers' Notice of 
Privacy Practices, to reduce burden and free up resources for covered 
entities to devote to coordinated care without compromising 
transparency or an individual's awareness of his or her rights.

II. Solicitation of Comments

    OCR is soliciting public comments that offer recommendations for 
modifying existing regulations or guidance, or developing new guidance, 
that could further the goals described below.

a. Promoting Information Sharing for Treatment and Care Coordination

    The Privacy Rule establishes an individual's right to access and 
obtain a copy of his or her PHI.\5\ The Privacy Rule currently requires 
a covered entity to provide an individual with access to his or her PHI 
within 30 days after receipt of a request (with the possibility of one 
30-day extension), and requires the covered entity to provide a copy of 
PHI to a third party, which may be a health care provider, when 
directed by an individual pursuant to the individual's right of access. 
These requirements apply equally to health records maintained 
electronically and in other media (e.g., paper). OCR seeks input on 
whether potential revisions to the right of access would support and 
promote care coordination and/or case management by enabling more 
timely transfer of PHI between covered entities, or between covered 
entities and other health care providers.
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    \5\ See 45 CFR 164.524.
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    Currently, under the Privacy Rule, the only required disclosures of 
PHI are (1) to the individual, pursuant to the individual's right to 
access, 45 CFR 164.524; and (2) to OCR for purposes of determining 
compliance with the HIPAA Rules. The Privacy Rule permits, but does not 
require, covered entities to use and disclose PHI for TPO purposes.\6\ 
Further, although the Privacy Rule requires covered entities to provide 
individuals with access to their PHI within 30 days of receiving a 
request (with the possibility for one 30-day extension),\7\ there is no 
deadline or requirement to disclose records when requested by another 
health care provider or other covered entity for purposes of 
coordinating care or managing cases. This can lead to circumstances 
where records are not transferred between covered entities (or from a 
covered entity to another health care provider) in a timely fashion to 
the detriment of coordinated care and/or case management. OCR seeks 
public input, including from individuals, covered entities, other 
health care providers, business associates, and other members of the 
public, on the scope of this problem, and on whether there are 
potential revisions to the Privacy Rule to support and promote care 
coordination and/or case management, including by requiring timely 
transfer of PHI for this purpose or other purposes, such as when a 
patient switches medical providers and their new provider requests the 
transfer of records from the previous provider.
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    \6\ ``Treatment means the provision, coordination, or management 
of health care and related services by one or more health care 
providers, including the coordination or management of health care 
by a health care provider with a third party; consultation between 
health care providers relating to a patient; or the referral of a 
patient for health care from one health care provider to another.'' 
45 CFR 164.501 (definition of ``treatment''); also see 45 CFR 
164.502(a)(1)(ii) and 164.506. The definition of ``health care 
operations'' includes, but is not limited to ``any of the following 
activities of the covered entity to the extent that the activities 
are related to covered functions: (1) Conducting quality assessment 
and improvement activities, including outcomes evaluation and 
development of clinical guidelines, provided that the obtaining of 
generalizable knowledge is not the primary purpose of any studies 
resulting from such activities; patient safety activities (as 
defined in 42 CFR 3.20); population-based activities relating to 
improving health or reducing health care costs, protocol 
development, case management and care coordination, contacting of 
health care providers and patients with information about treatment 
alternatives; and related functions that do not include treatment; . 
. . .''
    \7\ 45 CFR 164.524(b)(2)(i).
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    The Privacy Rule generally requires that covered entities use, 
disclose, or request only the minimum PHI necessary to meet the purpose 
of the use, disclosure, or request.\8\ Disclosures to or requests by 
health care providers for treatment purposes, including care 
coordination and case management, are excepted from the minimum 
necessary requirement.\9\ Disclosures by covered entities for care 
coordination and/or case management activities to covered entities that 
are not health care providers remain subject to the minimum necessary 
standard.\10\ Similarly, disclosures related to care coordination and/
or case management but for non-treatment activities nevertheless remain 
subject to the minimum necessary standard, such as population-based 
case management and care coordination activities,\11\ claims 
management, review of health care services for appropriateness of care, 
utilization reviews,\12\ and formulary development.\13\ OCR seeks input 
on whether disclosures of PHI to non-provider covered entities for care 
coordination and/or case management as part of treatment, and/or health 
care operations, should be excepted from the minimum necessary 
standard, and if so, to what extent.
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    \8\ 45 CFR 164.502(b)(1).
    \9\ 45 CFR 164.502(b)(2)(i).
    \10\ Id.
    \11\ See 45 CFR 164.501 (definitions of ``health care 
operations,'' para. (1)).
    \12\ See 45 CFR 164.501 (definition of ``payment'').
    \13\ See 45 CFR 164.501 (definition of ``health care 
operations,'' para. (6)).
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    Finally, some individuals, such as those experiencing homelessness 
or suffering from chronic conditions, including serious mental illness, 
receive care from a variety of sources including HIPAA covered 
entities, social service agencies, and community-based support 
programs. In addition, some jurisdictions have established multi-
disciplinary teams that assist in coordinating the full spectrum of 
care for individuals who need such assistance. Coordinating the care 
and related services requires sharing PHI among those involved. 
Although the Privacy Rule permits a covered health care provider to 
disclose information to a third party for the coordination or 
management of treatment,\14\ some HIPAA covered entities have expressed 
reluctance to share this information for fear of violating HIPAA. OCR 
therefore requests input on whether it should modify or otherwise 
clarify provisions of the Privacy Rule to encourage covered entities to 
share PHI with non-covered entities when needed to coordinate care and 
provide related health care services and support for individuals in 
these situations. This request asks whether an express regulatory 
permission should be created for HIPAA covered entities to disclose PHI 
to social service agencies or community-based support programs,

[[Page 64304]]

and the requirements or conditions upon which the regulatory permission 
should be based, including whether covered entities should be required 
to enter into agreements with such entities that contain provisions 
similar to the provisions in business associate agreements.\15\ For all 
questions, we request information about any relevant state or other law 
containing standards that are different from, and perhaps inconsistent 
with, either existing HIPAA requirements or potential proposed changes 
to the HIPAA Rules.
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    \14\ 45 CFR 164.501 (definition of ``treatment'').
    \15\ See 45 CFR 164.502(a)(3), 164.504(e)(2).
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    OCR requests comment on these issues, including on the following 
questions:
    (1) How long does it take for covered entities to provide an 
individual with a copy of their PHI when requested pursuant to the 
individual's right of access at 45 CFR 164.524? How long does it take 
for covered entities to provide other covered entities copies of 
records that are not requested pursuant to the individual's right of 
access? Does the length of time vary based on whether records are 
maintained electronically or in another form (e.g., paper)? Does the 
length of time vary based on the type of covered entity? For instance, 
do some types of health care providers or plans take longer to respond 
to requests than others?
    (2) How feasible is it for covered entities to provide PHI when 
requested by the individual pursuant to the right of access more 
rapidly than currently required under the rules? (The Privacy Rule 
requires covered entities to respond to a request in no more than 30 
days, with a possible one-time extension of an additional 30 days.). 
What is the most appropriate general timeframe for responses? Should 
any specific purposes or types of access requests by patients be 
required to have shorter response times?
    (3) Should covered entities be required to provide copies of PHI 
maintained in an electronic record more rapidly than records maintained 
in other media when responding to an individual's request for access? 
(The Privacy Rule does not currently distinguish, for timeliness 
requirements, between providing PHI maintained in electronic media and 
PHI maintained in other media). If so, what timeframes would be 
appropriate?
    (4) What burdens would a shortened timeframe for responding to 
access requests place on covered entities? OCR requests specific 
examples and cost estimates, where available.
    (5) Health care clearinghouses typically receive PHI in their role 
as business associates of other covered entities, and may provide an 
individual access to that PHI only insofar as required or permitted by 
their business associate agreement with the other covered entity, just 
as other covered entities, when performing business associate 
functions, may also provide access to PHI only as required or permitted 
by the business associate agreement(s) with the covered entity(ies) for 
whom they perform business associate functions. Nevertheless, the PHI 
that clearinghouses possess could provide useful information to 
individuals. For example, clearinghouses may maintain PHI from a 
variety of health care providers, which may help individuals obtain 
their full treatment histories without having to separately request PHI 
from each health care provider.
    (a) How commonly do business associate agreements prevent 
clearinghouses from providing PHI directly to individuals?
    (b) Should health care clearinghouses be subject to the individual 
access requirements, thereby requiring health care clearinghouses to 
provide individuals with access to their PHI in a designated record set 
upon request? Should any limitations apply to this requirement? For 
example, should health care clearinghouses remain bound by business 
associate agreements with covered entities that do not permit 
disclosures of PHI directly to an individual who is the subject of the 
PHI?
    (c) Alternatively, should health care clearinghouses be treated 
only as covered entities--i.e., be subject to all requirements and 
prohibitions in the HIPAA Rules concerning the use and disclosure of 
PHI and the rights of individuals in the same way as other covered 
entities--and not be considered business associates, or need a business 
associate agreement with a covered entity, even when performing 
activities for, or on behalf of, other covered entities? Would this 
change raise concerns for other covered entities about their inability 
to limit uses and disclosures of PHI by health care clearinghouses? For 
example, would this change prevent covered entities from providing 
assurances to individuals about how their PHI will be used and 
disclosed? Or would covered entities be able to adequately fulfill 
individuals' expectations about uses and disclosures through normal 
contract negotiations with health care clearinghouses, without the need 
for a HIPAA business associate agreement? Would covered entities be 
able to impose other contractual limitations on the uses and 
disclosures of PHI by the health care clearinghouse?
    (d) If health care clearinghouses are not required to enter into 
business associate agreements with the other covered entities for whom 
they perform business associate functions, should such requirement also 
be eliminated for other covered entities when they perform business 
associate functions for other covered entities?
    (6) Do health care providers currently face barriers or delays when 
attempting to obtain PHI from covered entities for treatment purposes? 
For example, do covered entities ever affirmatively refuse or otherwise 
fail to share PHI for treatment purposes, require the requesting 
provider to fill out paperwork not required by the HIPAA Rules to 
complete the disclosure (e.g., a form representing that the requester 
is a covered health care provider and is treating the individual about 
whom the request is made, etc.), or unreasonably delay sharing PHI for 
treatment purposes? Please provide examples of any common scenarios 
that may illustrate the problem.
    (7) Should covered entities be required to disclose PHI when 
requested by another covered entity for treatment purposes? Should the 
requirement extend to disclosures made for payment and/or health care 
operations purposes generally, or, alternatively, only for specific 
payment or health care operations purposes?
    (a) Would this requirement improve care coordination and/or case 
management? Would it create unintended burdens for covered entities or 
individuals? For example, would such a provision require covered 
entities to establish new procedures to ensure that such requests were 
managed and fulfilled pursuant to the new regulatory provision and, 
thus, impose new administrative costs on covered entities? Or would the 
only new administrative costs arise because covered entities would have 
to manage and fulfill requests for PHI that previously would not have 
been fulfilled?
    (b) Should any limitation be placed on this requirement? For 
instance, should disclosures for healthcare operations be treated 
differently than disclosures for treatment or payment? Or should this 
requirement only apply to certain limited payment or health care 
operations purposes? If so, why?
    (c) Should business associates be subject to the disclosure 
requirement? Why or why not?
    (8) Should any of the above proposed requirements to disclose PHI 
apply to all covered entities (i.e., covered health

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care providers, health plans, and health care clearinghouses), or only 
a subset of covered entities? If so, which entities and why?
    (9) Currently, HIPAA covered entities are permitted, but not 
required, to disclose PHI to a health care provider who is not covered 
by HIPAA (i.e., a health care provider that does not engage in 
electronic billing or other covered electronic transactions) for 
treatment and payment purposes of either the covered entity or the non-
covered health care provider.\16\ Should a HIPAA covered entity be 
required to disclose PHI to a non-covered health care provider with 
respect to any of the matters discussed in Questions 7 and 8? Would 
such a requirement create any unintended adverse consequences? For 
example, would a covered entity receiving the request want or need to 
set up a new administrative process to confirm the identity of the 
requester? Do the risks associated with disclosing PHI to health care 
providers not subject to HIPAA's privacy and security protections 
outweigh the benefit of sharing PHI among all of an individual's health 
care providers?
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    \16\ See 45 CFR 164.506(c)(1)-(3).
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    (10) Should a non-covered health care provider requesting PHI from 
a HIPAA covered entity provide a verbal or written assurance that the 
request is for an accepted purpose (e.g., TPO) before a potential 
disclosure requirement applies to the covered entity receiving the 
request? If so, what type of assurance would provide the most 
protection to individuals without imposing undue burdens on covered 
entities? How much would it cost covered entities to comply with this 
requirement? Please provide specific cost estimates where available.
    (11) Should OCR create exceptions or limitations to a requirement 
for covered entities to disclose PHI to other health care providers (or 
other covered entities) upon request? For example, should the 
requirement be limited to PHI in a designated record set? Should 
psychotherapy notes or other specific types of PHI (such as genetic 
information) be excluded from the disclosure requirement unless 
expressly authorized by the individual?
    (12) What timeliness requirement should be imposed on covered 
entities to disclose PHI that another covered entity requests for TPO 
purposes, or a non-covered health care provider requests for treatment 
or payment purposes? Should all covered entities be subject to the same 
timeliness requirement? For instance, should covered providers be 
required to disclose PHI to other covered providers within 30 days of 
receiving a request? Should covered providers and health plans be 
required to disclose PHI to each other within 30 days of receiving a 
request? Is there a more appropriate timeframe in which covered 
entities should disclose PHI for TPO purposes? Should electronic 
records and records in other media forms (e.g., paper) be subject to 
the same timeliness requirement? Should the same timeliness 
requirements apply to disclosures to non-covered health care providers 
when PHI is sought for the treatment or payment purposes of such health 
care providers?
    (13) Should individuals have a right to prevent certain disclosures 
of PHI that otherwise would be required for disclosure? For example, 
should an individual be able to restrict or ``opt out'' of certain 
types of required disclosures, such as for health care operations? 
Should any conditions apply to limit an individual's ability to opt out 
of required disclosures? For example, should a requirement to disclose 
PHI for treatment purposes override an individual's request to restrict 
disclosures to which a covered entity previously agreed?
    (14) How would a general requirement for covered health care 
providers (or all covered entities) to share PHI when requested by 
another covered health care provider (or other covered entity) interact 
with other laws, such as 42 CFR part 2 or state laws that restrict the 
sharing of information?
    (15) Should any new requirement imposed on covered health care 
providers (or all covered entities) to share PHI when requested by 
another covered health care provider (or other covered entity) require 
the requesting covered entity to get the explicit affirmative 
authorization of the patient before initiating the request, or should a 
covered entity be allowed to make the request based on the entity's 
professional judgment as to the best interest of the patient, based on 
the good faith of the entity, or some other standard?
    (16) What considerations should OCR take into account to ensure 
that a potential Privacy Rule requirement to disclose PHI is consistent 
with rulemaking by the Office of the National Coordinator for Health 
Information Technology (ONC) to prohibit ``information blocking,'' as 
defined by the 21st Century Cures Act? \17\
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    \17\ Sec 4004, Public Law 114-255, 130 Stat. 1033 (amending 
Subtitle C of title XXX of the Public Health Service Act by adding 
Sec. 3022(a)(3)).
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    (17) Should OCR expand the exceptions to the Privacy Rule's minimum 
necessary standard? For instance, should population-based case 
management and care coordination activities, claims management, review 
of health care services for appropriateness of care, utilization 
reviews, or formulary development be excepted from the minimum 
necessary requirement? Would these exceptions promote care coordination 
and/or case management? If so, how? Are there additional exceptions to 
the minimum necessary standard that OCR should consider?
    (18) Should OCR modify the Privacy Rule to clarify the scope of 
covered entities' ability to disclose PHI to social services agencies 
and community-based support programs where necessary to facilitate 
treatment and coordination of care with the provision of other services 
to the individual? For example, if a disabled individual needs housing 
near a specific health care provider to facilitate their health care 
needs, to what extent should the Privacy Rule permit a covered entity 
to disclose PHI to an agency that arranges for such housing? What 
limitations should apply to such disclosures? For example, should this 
permission apply only where the social service agency itself provides 
health care products or services? In order to make such disclosures to 
social service agencies (or other organizations providing such social 
services), should covered entities be required to enter into agreements 
with such entities that contain provisions similar to the provisions in 
business associate agreements?
    (19) Should OCR expressly permit disclosures of PHI to multi-
disciplinary/multi-agency teams tasked with ensuring that individuals 
in need in a particular jurisdiction can access the full spectrum of 
available health and social services? Should the permission be limited 
in some way to prevent unintended adverse consequences for individuals? 
For example, should covered entities be prevented from disclosing PHI 
under this permission to a multi-agency team that includes a law 
enforcement official, given the potential to place individuals at legal 
risk? Should a permission apply to multi-disciplinary teams that 
include law enforcement officials only if such teams are established 
through a drug court program? \18\ Should such a multi-disciplinary 
team be required to enter into a business associate (or similar) 
agreement with the covered entity?

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What safeguards are essential to preserving individuals' privacy in 
this context?
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    \18\ Information about drug courts is available at https://www.nij.gov/topics/courts/drug-courts/Pages/welcome.aspx.
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    (20) Would increased public outreach and education on existing 
provisions of the HIPAA Privacy Rule that permit uses and disclosures 
of PHI for care coordination and/or case management, without regulatory 
change, be sufficient to effectively facilitate these activities? If 
so, what form should such outreach and education take and to what 
audience(s) should it be directed?
    (21) Are there provisions of the HIPAA Rules that work well, 
generally or in specific circumstances, to facilitate care coordination 
and/or case management? If so, please provide information about how 
such provisions facilitate care coordination and/or case management. In 
addition, could the aspects of these provisions that facilitate such 
activities be applied to provisions that are not working as well?

b. Promoting Parental and Caregiver Involvement and Addressing the 
Opioid Crisis and Serious Mental Illness

    As discussed earlier, the Privacy Rule allows covered entities to 
disclose PHI to caregivers in certain circumstances, including certain 
emergency circumstances, and this permission has particular relevance 
today in relation to the opioid crisis and efforts to address serious 
mental illness (SMI).\19\ Nevertheless, anecdotal evidence suggests 
that some covered entities are reluctant to inform and involve the 
loved ones of individuals facing such health crises for fear of 
violating HIPAA. This reluctance may hinder effective coordination of 
care and case management involving caregivers, including family members 
and friends. In an effort to encourage covered entities to share 
necessary information with caregivers and loved ones, especially when 
an individual is suffering from substance use disorder (including 
opioid use disorder) or SMI, OCR is considering a separate rulemaking 
that would seek to encourage covered entities to share PHI with family 
members, caregivers, and others in a position to avert threats of harm 
to health and safety, when necessary to promote the health and recovery 
of those struggling with substance use disorder, including opioid use 
disorder, and/or SMI.\20\ OCR would like to consider amendments to the 
Privacy Rule that would allow OCR to address the opioid crisis as well 
as facilitate parental involvement in the treatment of their children.
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    \19\ See, e.g., 45 CFR 164.510(b)(3), 45 CFR 164.512(j).
    \20\ See RIN: 0945-AA09, Fall 2018 Unified Agenda, Office of 
Information and Regulatory Affairs, Office of Management and Budget, 
www.reginfo.gov.
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    Specifically, OCR requests comment on these issues, including the 
following:
    (22) What changes can be made to the Privacy Rule to help address 
the opioid epidemic? What risks are associated with these changes? For 
example, is there concern that encouraging more sharing of PHI in these 
circumstances may discourage individuals from seeking needed health 
care services? Also is there concern that encouraging more sharing of 
PHI may interfere with individuals' ability to direct and manage their 
own care? How should OCR balance the risk and the benefit?
    (23) How can OCR amend the HIPAA Rules to address serious mental 
illness? For example, are there changes that would facilitate treatment 
and care coordination for individuals with SMI, or ensure that family 
members and other caregivers can be involved in an individual's care? 
What are the perceived barriers to facilitating this treatment and care 
coordination? Would encouraging more sharing in the context of SMI 
create concerns similar to any concerns raised in relation to the 
previous question on the opioid epidemic? If so, how could such 
concerns be mitigated?
    (24) Are there circumstances in which parents have been unable to 
gain access to their minor child's health information, especially where 
the child has substance use disorder (such as opioid use disorder) or 
mental health issues, because of HIPAA? Please specify, if known, how 
the inability to access a minor child's information was due to HIPAA, 
and not state or other law.
    (25) Could changes to the Privacy Rule help ensure that parents are 
able to obtain the treatment information of their minor children, 
especially where the child has substance use disorder (including opioid 
use disorder) or mental health issues, or are existing permissions 
adequate? If the Privacy Rule is modified, what limitations on parental 
access should apply to respect any privacy interests of the minor 
child?
    (a) Currently, the Privacy Rule generally defers to state law with 
respect to whether a parent or guardian is the personal representative 
of an unemancipated minor child and, thus, whether such parent or 
guardian could obtain PHI about the child as his/her personal 
representative; if someone other than the parent or guardian can or 
does provide consent for particular health care services, the parent or 
guardian is generally not the child's personal representative with 
respect to such health care services.\21\ Should these standards be 
reconsidered generally, or specifically where the child has substance 
use disorder or mental health issues?
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    \21\ See 45 CFR 164.502(g)(3).
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    (b) Should any changes be made to specifically allow parents or 
spouses greater access to the treatment information of their children 
or spouses who have reached the age of majority? If the Privacy Rule is 
changed to encourage parental and spousal involvement, what limitations 
should apply to respect the privacy interests of the individual 
receiving treatment?
    (c) Should changes be made to allow adult children to access the 
treatment records of their parents in certain circumstances, even where 
an adult child is not the parent's personal representative? \22\ Or are 
existing permissions sufficient? For instance, should a child be able 
to access basic information about the condition of a parent who is 
being treated for early-onset dementia or inheritable diseases? If so, 
what limitations should apply to respect the privacy interests of a 
parent?
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    \22\ See 45 CFR 164.502(g).
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    (26) The Privacy Rule currently defers to state or other applicable 
law to determine the authority of a person, such as a parent or spouse, 
to act as a personal representative of an individual in making 
decisions related to their health care.\23\ How should OCR reconcile 
any changes to a personal representative's authority under HIPAA with 
state laws that define the scope of parental or spousal authority for 
state law purposes?
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    \23\ See 45 CFR 164.502(g).
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c. Accounting of Disclosures

    The Privacy Rule requires covered entities to provide an 
individual, upon request, with an accounting of certain disclosures of 
the individual's PHI that were made by the covered entity or its 
business associate during the six years before the request. See 45 CFR 
164.528. While the Privacy Rule currently excludes certain disclosures 
from the accounting requirement, including disclosures made for TPO 
purposes, see 45 CFR 164.528(a), section 13405(c) of the HITECH Act 
directs the Department to modify the Privacy Rule to require that an 
accounting of disclosures include disclosures made for TPO purposes 
through an electronic health record during the three years before the 
request.
    In 2010, OCR issued a Request for Information (``2010 RFI'') \24\ 
``to help us

[[Page 64307]]

better understand the interests of individuals with respect to learning 
of such disclosures [for TPO], the administrative burden on covered 
entities and business associates of accounting for such disclosures, 
and other information that may inform the Department's rulemaking in 
this area.'' After reviewing public comments, OCR issued a Notice of 
Proposed Rulemaking (``2011 NPRM'') \25\ proposing several 
modifications to the Privacy Rule to implement the HITECH Act 
requirement, improve the workability of the accounting of disclosures, 
and create a new right to an access report.
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    \24\ 75 FR 23214 (May 3, 2010). Available at https://www.gpo.gov/fdsys/pkg/FR-2010-05-03/pdf/2010-10054.pdf.
    \25\ 76 FR 31426 (May 31, 2011). Available at https://www.gpo.gov/fdsys/pkg/FR-2011-05-31/pdf/2011-13297.pdf.
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    Based on public feedback on the RFI that many covered entities' 
systems could not distinguish between internal access (a ``use'' under 
the Privacy Rule) and external access (a ``disclosure'') for TPO, and 
that providing a full accounting of disclosures for TPO would be overly 
burdensome to regulated entities, OCR proposed, in addition, to provide 
individuals with a right to receive an ``access report.'' The access 
report would have shown who had accessed the information in an 
individual's electronic designated record set (which would include any 
access, not only access that represented a disclosure outside of the 
entity for TPO). Commenters on the NPRM overwhelmingly opposed the 
proposed individual right to obtain an ``access report.'' Many 
commenters expressed concern that their then-existing, commonly used 
EHR systems did not have the technical capability to produce the 
required access report and updates would be prohibitively costly for 
covered entities. In addition, some commenters stated that the content 
and format of the proposed access report would not provide meaningful, 
usable information to individuals. A virtual hearing conducted by a 
federal advisory committee in 2013 elicited similar concerns from the 
public and presenters at the hearing.\26\
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    \26\ https://www.healthit.gov/hitac/events/policy-privacy-security-tiger-team-accounting-disclosures-virtual-hearing.
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    OCR has not taken action to finalize the proposed accounting of 
disclosures rule since the comment period closed in 2011, and it now 
believes that the proposed access report requirement would create undue 
burden for covered entities without providing meaningful information to 
individuals. Thus, OCR intends to withdraw the NPRM, and requests 
public input on the questions below to help OCR to implement the HITECH 
Act requirement and ensure that individuals can obtain a meaningful 
accounting of disclosures that gives them confidence that their PHI is 
being disclosed appropriately as part of receiving coordinated care or 
otherwise, without erecting obstacles or disincentives to the adoption 
and use of interoperable electronic healthcare records, which is 
necessary for efficient care coordination, case management, and value-
based healthcare.
    OCR requests public input on these issues and specifically on 
following questions:
    (27) How many requests for an accounting of disclosures do covered 
entities receive annually and from what percentage of total patients? 
Of these, how many requests specify a particular preferred electronic 
form or format, and to what extent do covered entities provide the 
accounting in the requested form or format?
    (28) How much time do covered entities take to respond to an 
individual's request for an accounting of disclosures? How many worker-
hours are needed to produce the accounting? What is the average number 
of days between receipt of a request and providing the accounting to 
the requesting individual? How would these estimated time periods 
change, if at all, if covered entities were to provide a full 
accounting of disclosures for TPO purposes? What is the basis for these 
revised estimates?
    (29) If your covered entity does capture and maintain information 
about TPO accounting, even though it is not currently required by the 
Privacy Rule, what is the average number of TPO disclosures made by the 
entity for a given individual in a calendar year? How many such 
disclosures are made from EHRs?
    (30) In what scenarios would a business associate make a disclosure 
of PHI for TPO through an EHR? What is the average number of such 
disclosures for a given individual in a calendar year, if known?
    (31) Should the Department require covered entities to account for 
their business associates' disclosures for TPO, or should a covered 
entity be allowed to refer an individual to its business associate(s) 
to obtain this information? What benefits and burdens would covered 
entities and individuals experience under either of these options?
    (32) For existing EHR systems:
    (a) Is the system able to distinguish between ``uses'' and 
``disclosures'' as those terms are defined under the Privacy Rule at 45 
CFR 160.103? (Note that the term ``disclosure'' includes, but is not 
limited to, the sharing of information between a hospital and 
physicians who may have staff privileges but who are not members of its 
workforce).
    (b) If the existing system only records access to information 
without identifying whether such access represents a use or disclosure, 
what information is recorded about each instance of access? How long is 
such information retained? What would be the burden for covered 
entities to retain the information for three years? Once collected, 
what additional costs or other resources would be required to maintain 
the data for each subsequent year? At what point would retention of the 
information be excessively burdensome? OCR requests specific examples 
and cost estimates, where available.
    (c) If the system is able to distinguish between uses and 
disclosures of information, what details regarding each disclosure are 
automatically collected by the system (i.e., collected without 
requiring any additional manual input by the person making the 
disclosure)? What information, if any, is manually entered by the 
person making the disclosure or accessing the information?
    (d) If the system is able to distinguish between uses and 
disclosures of information, what data elements are automatically 
collected by the system for uses (i.e., collected without requiring any 
additional manual input by the person making the disclosure)? What 
information, if any, is manually entered by the person making the use?
    (e) If the system is able to distinguish between uses and 
disclosures of information, does it record a description of disclosures 
in a standardized manner (for example, does the system offer or require 
a user to select from a limited list of types of disclosures)? If yes, 
is the feature being utilized? What are the benefits and drawbacks?
    (f) To what extent do covered entities maintain a single, 
centralized EHR system versus a decentralized system (e.g., different 
departments maintain different EHR systems, and an accounting of 
disclosures for TPO would need to be tracked for each system)? To what 
extent are covered entities that currently use decentralized systems 
planning to migrate to centralized systems or vice versa? How is the 
industry mix of centralized and decentralized systems likely to change 
over the next five or ten years?
    (g) Do existing EHR systems automatically generate an accounting of 
disclosures under the current Privacy Rule (i.e., does the system 
account for disclosures other than to carry out TPO)? If so, what would 
be the additional burden to also account for

[[Page 64308]]

disclosures to carry out TPO? If not, to what extent do covered 
entities use a separate system or module to generate an accounting of 
disclosures, and does the system interface with the EHR system? OCR 
requests cost estimates, where available.
    (33) If an EHR is not currently able to account for disclosures of 
an EHR to carry out TPO, what would be the burden, in time and 
financial costs, for covered entities and/or their vendors to implement 
such a feature?
    (34) For covered entities already planning to adopt new EHRs, to 
what extent would a requirement to track TPO disclosures affect the 
cost of the new system?
    (35) A covered entity's Notice of Privacy Practices must inform 
individuals of the right to obtain an accounting of disclosures. Is 
this notice sufficient to make patients aware of this right? If not, 
what actions by OCR could effectively raise awareness?
    (36) Why do individuals make requests for an accounting of 
disclosures under the current rule? Why would individuals make requests 
for an accounting of TPO disclosures made through EHRs?
    (37) What data elements should be provided in an accounting of TPO 
disclosures, and why? How important is it to individuals to know the 
specific purpose of a disclosure--i.e., would it be sufficient to 
describe the purpose generally (e.g., for ``for treatment,'' ``for 
payment,'' or ``for health care operations purposes''), or is more 
detail necessary for the accounting to be of value? To what extent are 
individuals familiar with the range of activities that constitute 
``health care operations?'' On what basis do commenters make this 
assessment?
    (38) How frequently do individuals who obtain an accounting of 
disclosures request additional information not currently required to be 
included in the accounting (e.g., information about internal uses or 
about disclosures for TPO)? What additional information do they 
request, and do covered entities provide the additional information? 
Why or why not?
    (39) If covered entities are unable to modify existing systems or 
processes to generate a full accounting of disclosures for TPO (e.g., 
because modification would be prohibitively costly), should OCR instead 
require covered entities to conduct and document a diligent 
investigation into disclosures of PHI upon receiving an individual's 
request for an accounting of disclosures for TPO? If not, are there 
certain circumstances or allegations that should trigger such an 
investigation and documentation by a covered entity? How much time 
should a covered entity be allowed to conduct and provide the results 
of such an investigation?
    (40) If OCR requires or permits covered entities to conduct an 
investigation into TPO disclosures in lieu of providing a standard 
accounting of such disclosures, what information should the entities be 
required to report to the individual about the findings of the 
investigation? For example, should OCR require covered entities to 
provide individuals with the names of persons who received TPO 
disclosures and the purpose of the disclosures?
    (41) The HITECH Act section 13405(c) only requires the accounting 
of disclosures for TPO to include disclosures through an EHR. In its 
rulemaking, should OCR likewise limit the right to obtain an accounting 
of disclosures for TPO to PHI maintained in, or disclosed through, an 
EHR? Why or why not? What are the benefits and drawbacks of including 
TPO disclosures made through paper records or made by some other means 
such as orally? Would differential treatment between PHI maintained in 
other media and PHI maintained electronically in EHRs (where only EHR 
related accounting of disclosures would be required) disincentivize the 
adoption of, or the conversion to, EHRs?
    (42) Please provide any other information that OCR should consider 
when developing a proposed rule on accounting for disclosures for TPO.

d. Notice of Privacy Practices

    The Privacy Rule requires covered providers and health plans to 
develop a Notice of Privacy Practices (NPP) that describes individuals' 
heath information privacy rights and how their health information may 
be used and disclosed by the covered entity.\27\ Covered entities are 
required to provide their NPPs to individuals, consistent with the 
specific requirements of the Privacy Rule, including prominent display 
on their websites. In addition, a covered health care provider that has 
a direct treatment relationship with the individual must clearly and 
prominently post the NPP in physical service delivery locations. 
Providers must also provide the NPP to individuals by the date of first 
service delivery, and to any individual upon request.
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    \27\ 45 CFR 164.520.
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    In addition, the Privacy Rule requires covered providers that have 
a direct treatment relationship with an individual to make a good faith 
effort to obtain a written acknowledgement of receipt of the provider's 
NPP. If providers are unable to obtain the written acknowledgement, 
they must document their good faith efforts and the reason for not 
obtaining an individual's acknowledgment, and the provider must 
maintain the documentation or sufficient proof to support compliance 
with the requirements for six years.\28\ OCR established the 
requirement to make a good faith attempt to obtain a written 
acknowledgment in the August 14, 2002, final Privacy Rule modifications 
(67 FR 53182). That final rule strengthened the notice requirements, in 
part, to replace the previous requirement to obtain an individual's 
consent for uses and disclosures of PHI for treatment, payment, and 
health care operations, which would have created unnecessary barriers 
to the provision of health care and other routine and important health 
sector activities. The written acknowledgment process was intended to 
provide an opportunity for the individual to review the NPP, including 
the individual's privacy rights, to discuss any concerns related to the 
privacy of her or his PHI, and to request additional restrictions or 
confidentiality of communications.
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    \28\ 45 CFR 164.520(c)(2)(ii) and (e).
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    The questions below seek public input on whether the signature and 
recordkeeping requirements should be eliminated to reduce burden on 
providers and to free up time and resources for providers to spend on 
treatment and care coordination. The questions also ask how the NPP 
requirements might be modified in other ways to alleviate covered 
entity burden without compromising transparency regarding providers' 
privacy practices or an individual's awareness of his or her rights.
    (43) What is the burden, in economic terms, for covered health care 
providers that have a direct treatment relationship with an individual 
to make a good faith effort to obtain an individual's written 
acknowledgment of receipt of the provider's NPP? OCR requests estimates 
of labor hours and any other costs incurred, where available.
    (44) For what percentage of individuals with whom a direct 
treatment provider has a relationship is such a covered health care 
provider unable to obtain an individual's written acknowledgment? What 
are the barriers to obtaining it?
    (45) How often do individuals and covered entities mistake the 
signature or acknowledgment line that accompanies NPPs as contracts, 
waivers of rights, or required as a condition of receiving services? 
What conflicts have arisen

[[Page 64309]]

because of these or other misunderstandings?
    (46) What other state and federal laws, guidelines or standards 
require covered health care providers to obtain the patient's 
acknowledgement or signature on a document at their first visit? How 
many of those documents require patient signatures? What is the nature 
of those other documents that require signatures?
    (47) How often are NPPs bundled with other documents at patient 
``intake'' and with how many other pages of documents? How often are 
NPPs printed with non-NPP materials, either on the same page, or as a 
continuation of one integrated document, or as being physically 
attached to other documents? What is the nature of these non-NPP 
materials? How often, if at all, are covered health care providers 
required to have the patient sign updated versions of these forms 
(e.g., annually, each visit, no subsequent updates required)? Are 
electronic signatures permitted for these forms? If so, does this make 
the process less burdensome?
    (48) If NPP training is part of your general annual training, how 
much of this training cost do you estimate your organization spends to 
train covered entity staff on their obligations to seek and maintain 
documents related to the NPP acknowledgment requirements?
    (49) What is the burden, in economic terms, for covered health care 
providers to maintain documentation of the acknowledgment or the good 
faith effort to obtain written acknowledgment and the reason why the 
acknowledgment was not obtained? What alternative methods might 
providers find useful to document that they provided the NPP? For 
example, to what extent would the use of a standard patient intake 
checklist reduce the burden?
    (50) What use, if any, do covered health care providers make of the 
signed NPP forms, or documentation of good faith efforts at securing 
written acknowledgments, that the Privacy Rule requires providers to 
maintain?
    (51) What benefits or adverse consequences may result if OCR 
removes the requirement for a covered health care provider that has a 
direct treatment relationship with an individual to make a good faith 
effort to obtain an individual's written acknowledgment of the receipt 
of the provider's NPP? Please specify whether identified benefits or 
adverse consequences would accrue to individuals or covered providers.
    (52) Are there modifications to the content and provision of NPP 
requirements that would lessen the burden of compliance for covered 
entities while preserving transparency about covered entities' privacy 
practices and individuals' awareness of privacy rights? Please identify 
specific benefits and burdens to the covered entity and individual, and 
offer suggested modifications.
    (53) With the assistance of consumer-oriented focus groups, OCR has 
developed several model NPPs, available at https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/model-notices-privacy-practices/index.html, that clearly identify, in a consumer-friendly manner, an 
individual's HIPAA rights and a covered entity's ability to use and 
disclose PHI.
    (a) While covered entities are required to provide individuals an 
NPP, use of OCR's model NPPs is optional. Do covered entities use these 
model NPPs? Why or why not?
    (b) OCR has received anecdotal evidence that individuals are not 
fully aware of their HIPAA rights. What are some ways that individuals 
can be better informed about their HIPAA rights and how to exercise 
those rights? For instance, should OCR create a safe harbor for covered 
entities that use the model NPPs by deeming entities that use model 
NPPs compliant with the NPP content requirements? Would a safe harbor 
create any unintended adverse consequences?
    (c) Should more specific information be required to be included in 
NPPs than what is already required? If so, what specific information? 
For example, would a requirement of more detailed information on the 
right of patients to access their medical records (and related 
limitations of what can be charged for copies) be useful?
    (d) Please identify other specific recommendations for improving 
the NPP text or dissemination requirements to ensure individuals are 
informed of their HIPAA rights.

e. Additional Ways To Remove Regulatory Obstacles and Reduce Regulatory 
Burdens To Facilitate Care Coordination and Promote Value-Base Health 
Care Transformation

    As noted at the beginning of this RFI, OCR seeks public input on 
ways to modify the HIPAA Rules to remove regulatory obstacles and 
decrease regulatory burdens in order to facilitate efficient care 
coordination and/or case management and promote the transformation to 
value-based health care, while preserving the privacy and security of 
PHI. Specifically:
    (54) In addition to the specific topics identified above, OCR 
welcomes additional recommendations for how the Department could amend 
the HIPAA Rules to further reduce burden and promote coordinated care.
    (a) What provisions of the HIPAA Rules may present obstacles to, or 
place unnecessary burdens on, the ability of covered entities and/
business associates to conduct care coordination and/or case 
management? What provisions of the HIPAA Rules may inhibit the 
transformation of the health care system to a value-based health care 
system?
    (b) What modifications to the HIPAA Rules would facilitate 
efficient care coordination and/or case management, and/or promote the 
transformation to value-based health care?
    (c) OCR also broadly requests information and perspectives from 
regulated entities and the public about covered entities' and business 
associates' technical capabilities, individuals' interests, and ways to 
achieve these goals.
    This is a request for information only. Respondents are encouraged 
to provide complete but concise responses to the questions outlined 
above. OCR also requests that commenters indicate throughout their 
responses the questions to which they are responding. OCR notes that a 
response to every question is not required. This request for 
information is issued solely for information and planning purposes; it 
does not constitute a notice of proposed rulemaking.

III. Collection of Information Requirements

    This document does not impose information collection requirements, 
that is, reporting, recordkeeping or third-party disclosure 
requirements. This request for information constitutes a general 
solicitation of comments. In accordance with the implementing 
regulations of the Paperwork Reduction Act (PRA) at 5 CFR 1320.3(h)(4), 
information subject to the PRA does not generally include ``facts or 
opinions submitted in response to general solicitations of comments 
from the public, published in the Federal Register or other 
publications, regardless of the form or format thereof, provided that 
no person is required to supply specific information pertaining to the 
commenter, other than that necessary for self-identification, as a 
condition of the agency's full consideration of the comment.'' 
Consequently, this document need not be reviewed by the Office of 
Management and Budget under the authority of the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501 et seq.).


[[Page 64310]]


    Dated: December 10, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2018-27162 Filed 12-12-18; 11:15 am]
 BILLING CODE 4153-01-P