[Federal Register Volume 84, Number 165 (Monday, August 26, 2019)]
[Proposed Rules]
[Pages 44566-44568]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17816]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 2

[SAMHSA-4162-20]
RIN 0930-AA30


Confidentiality of Substance Use Disorder Patient Records

AGENCY: Substance Abuse and Mental Health Services Administration 
(SAMHSA), U.S. Department of Health and Human Services (HHS).

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: HHS proposes to amend its Confidentiality of Substance Use 
Disorder Patient Records regulation, to clarify one of the conditions 
under which a court may authorize disclosure of confidential 
communications made by a patient to a part 2 program as defined in this 
regulation. This change will clarify that a court may authorize 
disclosure of confidential communications when the disclosure is 
necessary in connection with investigation or prosecution of an 
extremely serious crime, even if the extremely serious crime was not 
allegedly committed by the patient.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below no later than 5 p.m. on September 25, 
2019.

ADDRESSES: You may submit comments, identified by Regulatory 
Information Number (RIN) 0930-AA30, by any of the following methods. 
Please submit your comments in only one of these ways to minimize the 
receipt of duplicate submissions.
    1. Federal eRulemaking Portal: You may submit comments 
electronically at http://www.regulations.gov. Follow the instructions 
for submitting comments. This is the preferred method for the 
submission of comments.
    2. Mail: Written comments must be sent to the following address: 
Attn: Mitchell Berger, SAMHSA, 5600 Fishers Lane, Room 18E89C, 
Rockville, Maryland 20857; or Suzette Brann, SAMHSA, 5600 Fishers Lane, 
Room 13E01B, Rockville, Maryland.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    Inspection of Public Comments: All comments received before the 
close of the comment period will be available to the public in their 
entirety including any personally identifiable and/or confidential 
information. Submitted comments may be inspected on http://www.regulations.gov or in-person, by appointment (Monday through Friday 
from 8:30 a.m. to 4 p.m.), at the headquarters of the SAMHSA, 5600 
Fishers Lane, Rockville, Maryland 20857. To schedule an appointment to 
view submitted comments at SAMHSA's headquarters, contact Mitchell 
Berger at (240) 276-1757 or Suzette Brann at (240) 276-1252.

FOR FURTHER INFORMATION CONTACT: Mitchell Berger at (240) 276-1757 or 
Suzette Brann at (240) 276-1252 or by email at: 
[email protected].

Table of Contents

I. Legal Authority
II. Background and Summary
III. Proposed Rule
IV. Regulatory Impact Analysis

I. Legal Authority

    HHS is proposing this rule under the authority of 42 U.S.C. 290dd-
2.

II. Background and Summary

    On January 18, 2017, HHS published a final rule (82 FR 6052) (2017 
final rule) that made certain changes to the regulations governing the 
confidentiality of substance use disorder patient records at 42 CFR 
part 2 (part 2). The part 2 regulations apply to part 2 programs. 
Briefly, as stated in the 2017 final rule, SAMHSA defines a part 2 
program as a federally assisted program (federally assisted as defined 
in Sec.  [thinsp]2.12(b) and program as defined in Sec.  [thinsp]2.11). 
See Sec.  [thinsp]2.12(e)(1) for examples.\1\
---------------------------------------------------------------------------

    \1\ (See 82 FR 6052, 6061 (January 18, 2017)).
---------------------------------------------------------------------------

    HHS did not intend in the 2017 final rule to substantively revise 
the provision of part 2 governing confidential communications that 
appears in Sec.  2.63. However, the phrase ``allegedly committed by the 
patient'' was erroneously added to Sec.  2.63(a)(2) in the 2017 final 
rule. The fact that the preamble of the 2017 final rule did not address 
that change, or explain its intended reasoning, indicates that no 
substantive change was intended. What is more, since publication of the 
2017 final rule, it has come to our attention that the erroneous 
addition of the phrase ``allegedly committed by the patient'' may 
hinder federal enforcement efforts targeted at rogue doctors and pill 
mills that have contributed to the opioid crisis.
    The prompt revision of this rule is necessary to help address one 
of the largest drug crises in the nation's history. HHS and the U.S. 
Department of Justice (DOJ) have developed extensive information 
concerning the nature and magnitude of the crisis.\2\ In particular, 
former HHS Acting Secretary Eric Hargan declared a public health 
emergency on October 26, 2017, to address the national opioid crisis 
and, most recently, HHS Secretary Alex Azar renewed that declaration on 
July 23, 2018. The proposed correction of the part 2 rule would help to 
address this public health emergency by facilitating the prompt 
investigation and prosecution, if warranted, of opioid-related crimes 
allegedly committed by individuals other than patients. Specifically, 
this proposed rule would correct the error by removing the phrase 
``allegedly committed by the patient'' from Sec.  2.63(a)(2). SAMHSA 
believes that this rule, if adopted as proposed, will not have an 
additional impact on part 2 programs or others as section 2.63 would 
revert to the pre-2017 language.
---------------------------------------------------------------------------

    \2\ See, e.g., Department of Health and Human Services (October 
26, 2017). HHS Acting Secretary Declares Public Health Emergency to 
Address National Opioid Crisis. Retrieved from www.hhs.gov/about/news/2017/10/26/hhs-acting-secretary-declares-public-health-emergency-address-national-opioid-crisis.html; Centers for Disease 
Control and Prevention (n.d.). Retrieved from www.cdc.gov/drugoverdose/data; Centers for Disease Control and Prevention, 
National Center for Health Statistics (December 2017). Drug Overdose 
Deaths in the United States, 1999-2016. Retrieved from www.cdc.gov/nchs/products/databriefs/db294.htm; Substance Abuse and Mental 
Health Services Administration (September 2017). Key Substance Use 
and Mental Health Indicators in the United States: Results from the 
2016 National Survey on Drug Use and Health. Retrieved from 
www.samhsa.gov/data/sites/default/files/NSDUH-FFR1-2016/NSDUH-FFR1-2016.pdf; National Institute on Drug Abuse (March 2018). Opioid 
Overdose Crisis. Retrieved from www.drugabuse.gov/drugs-abuse/opioids/opioid-overdose-crisis; Drug Enforcement Administration, 
2017 National Drug Threat Assessment (Oct. 2017), at v, 25-43.
---------------------------------------------------------------------------

III. Proposed Rule

    HHS proposes to amend Sec.  2.63(a)(2) by deleting the phrase 
``allegedly committed by the patient'' that was erroneously added in 
the 2017 final rule.
    Under this proposal, the text would revert to the language that 
appeared in the part 2 rule since 1987.\3\
---------------------------------------------------------------------------

    \3\ See 52 FR 21796.
---------------------------------------------------------------------------

    This proposed change is further compelled by the opioid crisis, 
which was declared a public health emergency by the former Acting 
Secretary of HHS, pursuant to section 319 of the Public

[[Page 44567]]

Health Service Act, 42 U.S.C. 247d and renewed by HHS Secretary Azar. 
According to the Centers for Disease Control and Prevention, as many as 
350,000 Americans have died from an opioid overdose between 1999 and 
2016.\4\ A November 2017 report from the President's Council of 
Economic Advisors entitled ``The Underestimated Costs of the Opioid 
Crisis'' estimates that in 2015, the economic cost of the opioid crisis 
was $504 billion, or 2.8 percent of Gross Domestic Product that 
year.\5\ The President's Commission on Combatting Drug Addiction and 
the Opioid Crisis in its 2017 final report identifies the gravity of 
the opioid crisis and notes the importance of a comprehensive effort by 
federal partners, including DOJ and the Drug Enforcement 
Administration, to address this crisis.\6\
---------------------------------------------------------------------------

    \4\ Centers for Disease Control and Prevention (n.d.). 
Understanding the Epidemic. Retrieved from https://www.cdc.gov/drugoverdose/epidemic/index.html.
    \5\ The Council of Economic Advisers (2017). Retrieved from 
https://www.whitehouse.gov/sites/whitehouse.gov/files/images/The%20Underestimated%20Cost%20of%20the%20Opioid%20Crisis.pdf.
    \6\ Office of National Drug Control Policy (n.d.). Retrieved 
from https://www.whitehouse.gov/ondcp/presidents-commission/.
---------------------------------------------------------------------------

    As demand for treatment increases and new entities become part 2 
programs, the need to prevent drug trafficking and patient exploitation 
at or by part 2 programs makes it imperative to correct the error in 
Sec.  2.63(a)(2), which if left in its current form could be 
interpreted to hamper or impede federal enforcement efforts, in 
situations where malfeasance by a patient is not involved, but access 
to covered records may be necessary for investigatory and enforcement 
purposes. The proposed correction to Sec.  2.63(a)(2) is necessary to 
encourage valid enforcement efforts in the fight to address the opioid 
crisis, including investigations that involve disclosures of part 2 
program records authorized by court orders under Subpart E of 42 CFR 
part 2. HHS believes reverting to the previous language for this 
section is necessary to help reduce and deter drug trafficking at or 
from part 2 programs, and thereby to prevent the occurrence of 
extremely serious crimes from interfering with the delivery by part 2 
programs of high quality, medically necessary treatment to patients 
with substance use disorders.
    It may be necessary to examine confidential communications of a 
part 2 program to investigate and prosecute, if warranted, individuals 
other than a patient who engage in drug trafficking related to the drug 
abuse crisis. Specifically, these records may be necessary to establish 
that the part 2 program or an affiliated medical professional is 
trafficking drugs rather than providing appropriate treatment for 
substance abuse. Accordingly, HHS proposes to amend the text of Sec.  
2.63(a)(2) to remove the phrase ``allegedly committed by a patient.''

IV. Regulatory Impact Analysis

    HHS has examined the impacts of this proposed rule as required by 
Executive Order 12866 on Regulatory Planning and Review (September 30, 
1993), Executive Order 13563 on Improving Regulation and Regulatory 
Review (January 18, 2011), the Regulatory Flexibility Act (Pub. L. 96-
354), the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), 
Executive Order 13132 on Federalism (August 4, 1999), and Executive 
Order 13771 on Reducing Regulation and Controlling Regulatory Costs 
(January 30, 2017). HHS does not believe the proposed change 
constitutes an unfunded mandate, additional regulatory activity or 
imposes a cost or economic burden on part 2 programs.

Executive Orders 12866, 13563, 13132, and 13771

    Executive Order 12866 directs 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 is 
supplemental to, and reaffirms the principles, structures, and 
definitions governing regulatory review, as established in Executive 
Order 12866. The proposed changes in this rule will not have an annual 
effect on the economy of $100 million or more in at least one year. HHS 
notes that these proposed changes do not characterize a significant 
regulatory action under Executive Order 12866. The proposed change to 
2.63 has no discernible economic impact, is consistent with the 
policies of such agencies as the Department of Justice, does not alter 
program budgets or obligations of grant or loan recipients and raises 
no novel legal or policy questions. Indeed, as explained, this rule 
reverts to the pre-2017 language for this section, which had remained 
unchanged for more than 30 years.
    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 requirement costs on state 
and local governments, preempts state law, or otherwise has Federalism 
implications. This rule does not impose any costs on state or local 
governments, therefore, the requirements of Executive Order 13132 are 
not applicable.
    Executive Order 13771 directs Agencies to identify at least two 
existing regulations to repeal for every new regulation unless 
prohibited by law. The total incremental cost of all regulations issued 
in a given fiscal year must have costs within the amount of incremental 
costs allowed by the Director of the Office of Management and Budget, 
unless otherwise required by law or approved in writing by the Director 
of the Office of Management and Budget. This proposed rule is not 
expected to lead to the promulgation of a rule constituting a 
``regulatory action'' under Executive Order 13771.

Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) requires agencies that issue a 
regulation to analyze options for regulatory relief of small businesses 
if a rule has a significant impact on a substantial number of small 
entities. The RFA generally defines a ``small entity'' as (1) a 
proprietary firm meeting the size standards of the Small Business 
Administration; (2) a nonprofit organization that is not dominant in 
its field; or (3) a small government jurisdiction with a population of 
less than 50,000. (States and individuals are not included in the 
definition of ``small entity''). For similar rules, HHS considers a 
rule to have a significant economic impact on a substantial number of 
small entities if at least five percent of small entities experience an 
impact of more than three percent of revenue. HHS determines that this 
proposed rule does not have a significant economic impact on a 
substantial number of small entities. The proposed rule would merely 
correct an erroneous change made in 2017 to the longstanding 
regulations in 42 CFR 2.63, in order to avoid a possible interpretation 
that could hamper or impede federal enforcement efforts in the fight to 
address the opioid crisis, including investigations that involve 
disclosures of part 2 program records authorized by court orders.

Unfunded Mandates Reform Act

    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate,

[[Page 44568]]

or by the private sector, of $100,000,000 or more (adjusted annually 
for inflation) in any one year.'' In 2018 that threshold level is 
approximately $150 million. HHS does not expect the proposed rule to 
exceed the threshold.

Paperwork Reduction Act

    Under the Paperwork Reduction Act of 1995 (PRA), agencies are 
required to provide a 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. The change proposed in this rulemaking would result in no new 
reporting burdens. Comments are welcome on the accuracy of this 
statement.

Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
the Office of Information and Regulatory Affairs designated this rule 
as not a major rule, as defined by 5 U.S.C. 804(2).''

List of Subjects in 42 CFR Part 2

    Alcohol abuse, Alcoholism, Drug abuse, Grant programs--Health, 
Health records, Privacy, Reporting, and Recordkeeping requirements.

    For the reasons stated in the preamble, HHS proposes to amend 42 
CFR part 2 as follows:

PART 2--CONFIDENTIALITY OF SUBSTANCE USE DISORDER PATIENT RECORDS

    1. The authority citation for part 2 continues to read follows:

    Authority: 42 U.S.C. 290dd-2.

Subpart E--Court Orders Authorizing Disclosure and Use


Sec.  2.63  [Amended]

    2. Amend Sec.  2.63(a)(2) by removing the phrase ``allegedly 
committed by the patient''.

    Dated: August 1, 2019.
Elinore F. McCance-Katz,
Assistant Secretary for Mental Health and Substance Use, Substance 
Abuse and Mental Health Services Administration.
Alex M. Azar II,
Secretary.
[FR Doc. 2019-17816 Filed 8-22-19; 4:15 pm]
 BILLING CODE P