Confidentiality of Alcohol and Drug Abuse Patient Records, 26929-26932 [2014-10913]

Download as PDF Federal Register / Vol. 79, No. 91 / Monday, May 12, 2014 / Proposed Rules 2. Does Executive Order 13175 apply to this proposed rule? This action does not have tribal implications, as specified in Executive Order 13175. Proposing a site to the NPL does not impose any costs on a tribe or require a tribe to take remedial action. Thus, Executive Order 13175 does not apply to this proposed rule. G. Executive Order 13045: Protection of Children From Environmental Health and Safety Risks 1. What is Executive Order 13045? Executive Order 13045: ‘‘Protection of Children From Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997) applies to any rule that: (1) Is determined to be ‘‘economically significant’’ as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that the EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the agency. 2. Does Executive Order 13045 apply to this proposed rule? This proposed rule is not subject to Executive Order 13045 because it is not an economically significant rule as defined by Executive Order 12866, and because the agency does not have reason to believe the environmental health or safety risks addressed by this proposed rule present a disproportionate risk to children. tkelley on DSK3SPTVN1PROD with PROPOSALS H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use 1. What is Executive Order 13211? Executive Order 13211, ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,’’ (66 FR 28355, May 22, 2001) requires federal agencies to prepare a ‘‘Statement of Energy Effects’’ when undertaking certain regulatory actions. A Statement of Energy Effects describes the adverse effects of a ‘‘significant energy action’’ on energy supply, distribution and use, reasonable alternatives to the action and the expected effects of the alternatives on energy supply, distribution and use. 2. Does Executive Order 13211 apply to this proposed rule? This action is not a ‘‘significant energy action’’ as defined in Executive VerDate Mar<15>2010 17:57 May 09, 2014 Jkt 232001 Order 13211, because it is not likely to have a significant adverse effect on the supply, distribution or use of energy. Further, the agency has concluded that this rule is not likely to have any adverse energy impacts because proposing a site to the NPL does not require an entity to conduct any action that would require energy use, let alone that which would significantly affect energy supply, distribution or usage. Thus, Executive Order 13211 does not apply to this action. I. National Technology Transfer and Advancement Act 1. What is the National Technology Transfer and Advancement Act? Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104– 113, section 12(d) (15 U.S.C. 272 note), directs the EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs the EPA to provide Congress, through OMB, explanations when the agency decides not to use available and applicable voluntary consensus standards. 2. Does the National Technology Transfer and Advancement Act apply to this proposed rule? No. This proposed rulemaking does not involve technical standards. Therefore, the EPA did not consider the use of any voluntary consensus standards. J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations 1. What is Executive Order 12898? Executive Order (EO) 12898 (59 FR 7629, Feb. 16, 1994) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies and activities on minority populations and low-income populations in the United States. PO 00000 Frm 00060 Fmt 4702 Sfmt 4702 26929 2. Does Executive Order 12898 apply to this proposed rule? The EPA has determined that this proposed rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. As this rule does not impose any enforceable duty upon state, tribal or local governments, this rule will neither increase nor decrease environmental protection. List of Subjects in 40 CFR Part 300 Environmental protection, Air pollution control, Chemicals, Hazardous substances, Hazardous waste, Intergovernmental relations, Natural resources, Oil pollution, Penalties, Reporting and recordkeeping requirements, Superfund, Water pollution control, Water supply. Authority: 33 U.S.C. 1321(c)(2); 42 U.S.C. 9601–9657; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR 2923, 3 CFR, 1987 Comp., p. 193. Dated: May 1, 2014. Barry Breen, Principal Deputy Assistant Administrator, Office of Solid Waste and Emergency Response. [FR Doc. 2014–10832 Filed 5–9–14; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration 42 CFR Part 2 Confidentiality of Alcohol and Drug Abuse Patient Records Substance Abuse and Mental Health Services Administration, HHS. ACTION: Notice of Public Listening Session. AGENCY: The Substance Abuse and Mental Health Services Administration (SAMHSA) announces that it will hold a public listening session on Wednesday, June 11, 2014, to solicit information concerning the Confidentiality of Alcohol and Drug Abuse Patient Records Regulations, 42 CFR Part 2. This session will be held in Rockville, MD, to obtain direct input from stakeholders on updating the regulations. The scheduled listening session provides an opportunity for SAMHSA to seek public input on potential changes to the regulations. SUMMARY: E:\FR\FM\12MYP1.SGM 12MYP1 26930 Federal Register / Vol. 79, No. 91 / Monday, May 12, 2014 / Proposed Rules The listening session will be held on Wednesday, June 11, 2014, from 9:30 a.m. to 4:30 p.m. ADDRESSES: Participation: The listening session will be held at the Substance Abuse and Mental Health Services Administration at 1 Choke Cherry Road, Rockville, MD 20857, Lobby-level Sugarloaf Conference Room. SAMHSA will post the agenda and logistical information on how to participate via the phone or internet on the SAMHSA Web site at https:// www.samhsa.gov/healthprivacy in advance of the listening session. The session is open to the public and the entire day’s proceedings will be webcast, recorded, and made publicly available. Interested parties may participate in person or via webcast. Capacity is limited and registration is required. To register, go to https:// 42cfrpart2listeningsession.eventbrite.com. Registration will be open until we meet maximum capacity. In addition to attending the session in person and joining via webinar, the Agency offers several ways to provide comments, as enumerated below. The forum will begin with opening remarks from the SAMHSA official charged with moderating the session. The session location is accessible to persons with disabilities. You may submit comments using any of the following methods: • Mail: The Substance Abuse and Mental Health Services Administration, 1 Choke Cherry Road, Rockville, MD 20857, Room 5–1011. • Hand Delivery or Courier: 1 Choke Cherry Road, Rockville, MD 20857, Room 5–1011 between 9 a.m. and 5 p.m., ET, Monday through Friday, except federal holidays. • Email: PrivacyRegulations@ SAMHSA.hhs.gov. • Fax: 1–240–276–2900. Each submission must include the Agency name and the docket number for this notice. Comments must be received by 5:00 p.m. ET on Wednesday June 25, 2014. FOR FURTHER INFORMATION CONTACT: For information concerning the listening session or the live webcast, please contact Kate Tipping, Public Health Advisor, SAMHSA, 1 Choke Cherry Road, Rockville, MD 20857, Room 5–1011, (240) 276–1652 or email PrivacyRegulations@SAMHSA.hhs.gov. SUPPLEMENTARY INFORMATION: tkelley on DSK3SPTVN1PROD with PROPOSALS DATES: I. Background The federal statute (United States Code, Title 42, section 290dd–2) governing the confidentiality of VerDate Mar<15>2010 17:57 May 09, 2014 Jkt 232001 substance abuse treatment information guarantees the confidentiality of information for persons receiving substance abuse treatment services from federally assisted programs. Under the statute, a federally assisted substance abuse program generally may only release identifiable information related to substance abuse treatment services with the individual’s express consent. The federal regulations that implement this law—Title 42 of the Code of Federal Regulations Part 2 (42 CFR Part 2)— were last updated in 1987. Over the last 25 years, significant changes have occurred within the U.S. health care system that were not envisioned by these regulations, including new models of integrated care that are built on a foundation of information sharing to support coordination of patient care, the development of an electronic infrastructure for managing and exchanging patient data, the development of prescription drug monitoring programs and a new focus on performance measurement within the health care system. When the regulations were written, substance abuse treatment was primarily conducted by specialty treatment providers, and as a result, the impact on coordination of care was not raised as a core issue. SAMHSA has heard from stakeholders that some of the current consent requirements make it difficult for these new health care organizations including health information exchange organizations (HIEs), Accountable Care Organizations (ACOs), and others to share substance abuse treatment information. A number of organizations across the country are excluding substance abuse treatment data due to the difficulty and expense of implementing the functionality and workflow changes necessary to comply with current regulations. In these instances, patients are prevented from fully participating in integrated care efforts even if they are willing to provide consent. Behavioral health is essential to overall health and the costs of untreated substance abuse disorders, both personal and societal, are enormous. However, treatment for substance abuse disorders is still associated with discrimination. In addition, there may be potential serious civil and criminal consequences for the disclosure of this information beyond the health care context. There continues to be a need for confidentiality protections that encourage patients to seek treatment without fear of compromising their privacy. SAMHSA strives to facilitate information exchange while respecting PO 00000 Frm 00061 Fmt 4702 Sfmt 4702 the legitimate privacy concerns of patients due to the potential for discrimination and legal consequences. We hope to clarify the requirements associated with information exchange in these new models and reduce burdens associated with specific consent requirements that do not serve to protect patient privacy. In consideration of the concerns raised regarding the application of 42 CFR Part 2 to new health care models and the continued need for confidentiality protections, the Agency will conduct a public listening session to provide all interested parties the opportunity to share their views on the subject prior to the initiation of rulemaking. Members of the public are invited to attend and view the proceedings, with space available on a first-come, first-served basis (based on registration). Written comments may also be submitted at the session or through the process described above. SAMHSA asks listening session participants to consider the following questions in preparing to make comments at the listening session. Listening session attendees will also be provided with a list of these questions at the forum site: a. Applicability of 42 CFR Part 2 42 CFR Part 2 currently applies to federally funded individuals or entities that ‘‘hold themselves out as providing, and provide, alcohol or drug abuse diagnosis, treatment or treatment referral’’ including units within a general medical facility that hold themselves out as providing diagnosis, treatment or treatment referral (§ 2.11 Definitions, Program). The U.S. health care system is changing and more substance abuse treatment is occurring in general health care and integrated care settings which are typically not covered under the current regulations. It has also posed difficulties for identifying which providers are covered by Part 2; whether a provider or organization is covered by Part 2 can change depending on whether they advertise their substance abuse treatment services (i.e. ‘hold themselves out’), which can change over time. SAMHSA is considering options for defining what information is covered under 42 CFR Part 2. Covered information could be defined based on what substance abuse treatment services are provided instead of being defined by the type of facility providing the services. For example, the regulations could be applied to any federally assisted health care provider that provides a patient with specialty substance abuse treatment services. In E:\FR\FM\12MYP1.SGM 12MYP1 Federal Register / Vol. 79, No. 91 / Monday, May 12, 2014 / Proposed Rules tkelley on DSK3SPTVN1PROD with PROPOSALS this scenario, providers would not be covered if they provided only substance abuse screening, brief intervention, or other similar pre-treatment substance abuse services. • How would redefining the applicability of 42 CFR Part 2 impact patients, health care provider organizations, HIEs, CCOs, HIT vendors, etc.? • Would this change address stakeholder concerns? • Would this change raise any new concerns? b. Consent Requirements SAMHSA has heard a number of concerns from individuals and stakeholders regarding the current consent requirements of 42 CFR Part 2. 42 CFR 2.31 requires the written consent to include the name or title of the individual or the name of the organization to which the disclosure is to be made. This is commonly referred to as the ‘‘To Whom’’ consent requirement. Some stakeholders have reported that this requirement makes it difficult to include programs covered by 42 CFR Part 2 in HIEs, health homes, ACOs and CCOs. These organizations have a large and growing number of member providers and they generally do not have sophisticated consent management capabilities. Currently, a Part 2 compliant consent cannot include future un-named providers which requires the collection of updated consent forms whenever new providers join these organizations. As a result, many of these organizations are currently not including substance abuse treatment information in their systems. While technical solutions for managing consent collection are possible, SAMHSA is examining the consent requirements in § 2.31 to explore options for facilitating the flow of information within the health care context while ensuring the patient is fully informed and the necessary protections are in place. Specifically, we are analyzing the current requirements and considering the impact of adapting them to: 1. Allow the consent to include a more general description of the individual, organization, or health care entity to which disclosure is to be made. 2. Require the patient be provided with a list of providers or organizations that may access their information, and be notified regularly of changes to the list. 3. Require the consent to name the individual or health care entity permitted to make the disclosure. 4. Require that if the health care entity permitted to make the disclosure is VerDate Mar<15>2010 17:57 May 09, 2014 Jkt 232001 made up of multiple independent units or organizations that the unit, organization, or provider releasing substance abuse related information be specifically named. 5. Require that the consent form explicitly describe the substance abuse treatment information that may be disclosed. SAMHSA welcomes comments on patient privacy concerns as well as the anticipated impact of the consent requirements on integration of substance abuse treatment data into HIEs, health homes, ACOs, and CCOs. • Would these changes maintain the privacy protections for patients? • Would these changes address the concerns of HIEs, health homes, ACOs, and CCOs? • Would these changes raise any new concerns? c. Redisclosure SAMHSA has also heard numerous concerns regarding the prohibition on redisclosure (§ 2.32). Currently most EHRs don’t support data segmentation. Without this functionality, EHR systems must either keep alcohol and drug abuse patient records separate from the rest of the patient’s medical record or apply the 42 CFR Part 2 protections to the patient’s entire medical record if such record contains information that is subject to 42 CFR Part 2. SAMHSA is considering revising the redisclosure provision to clarify that the prohibition on redisclosure only applies to information that would identify an individual as a substance abuser, and allows other health-related information shared by the Part 2 program to be redisclosed, if legally permissible. This would allow HIT systems to more easily identify information that is subject to the prohibition on redisclosure enabling them to utilize other technological approaches to manage redisclosure. If data are associated with information about where the data were collected (data provenance) which reveals that the data were collected by a practice that exclusively treats addiction, the data would still be protected under the proposed change. • Would this type of change facilitate technical solutions for complying with 42 CFR Part 2 in an EHR or HIE environment? • Would these changes maintain the privacy protections for patients? d. Medical Emergency SAMHSA has heard concerns regarding the medical emergency exception of 42 CFR Part 2 (§ 2.51). The current regulations state that information may be disclosed without PO 00000 Frm 00062 Fmt 4702 Sfmt 4702 26931 consent ‘‘for the purpose of treating a condition which poses an immediate threat to the health of any individual and which requires immediate medical intervention.’’ The statute, however, states that records may be disclosed to medical personnel to the extent necessary to meet a bona fide medical emergency. SAMHSA is considering adapting the medical emergency exception to make it more in-line with the statutory language and to give providers more discretion as to when a bona fide emergency exists. For example, amending this standard to allow providers to use the medical emergency provision to prevent emergencies or to share information with a detoxification center when a patient is unable to provide informed consent due to their level of intoxication. • What factors should providers take into consideration in determining whether a medical emergency exists? • Are there specific use cases SAMHSA should take into consideration? • Are there patient concerns about the impact of this change on their privacy? e. Qualified Service Organization (QSO) SAMHSA has also heard concerns from payers and health management organizations related to disclosing information that is subject to 42 CFR Part 2 to health care entities (ACOs/ CCOs) for the purpose of care coordination and population health management; helping them to identify patients with chronic conditions in need of more intensive outreach. Under the current regulations, substance abuse information may not be shared for these purposes without consent. SAMHSA is analyzing the regulations to identify options for allowing Part 2 data to flow to health care entities for the purpose of care coordination and population management while maintaining patient protections. One potential solution includes expanding the definition of a qualified service organization (QSO; § 2.11) to explicitly include care coordination services and to allow a QSO Agreement (QSOA) to be executed between an entity that stores Part 2 information, such as a payer or an ACO that is not itself a Part 2 program, and a service provider. • Are there other use cases we should be taking into consideration? • Are there specific patient concerns about the impact of this change on their privacy? E:\FR\FM\12MYP1.SGM 12MYP1 26932 Federal Register / Vol. 79, No. 91 / Monday, May 12, 2014 / Proposed Rules f. Research tkelley on DSK3SPTVN1PROD with PROPOSALS Under the current regulations, the Part 2 ‘‘program director’’ has to authorize the release of information for scientific research purposes. This issue has been brought to SAMHSA’s attention from organizations that store patient health data, including data that are subject to Part 2, which may be used for research (e.g. health management organizations). Under the current regulatory framework, absent consent, these organizations do not have the authority to disclose Part 2 data for scientific research purposes to qualified researchers or research organizations. This issue can be addressed by expanding the authority for releasing data to qualified researchers/research organizations to other health care entities that receive and store Part 2 data, including third-party payers, HIEs, and care coordination organizations for the purposes of research, audit, or evaluation. SAMHSA is considering expanding the authority for releasing data to qualified researchers/research organizations to health care entities that receive and store Part 2 data, including third-party payers, health management organizations, HIEs, and care coordination organizations. • Are there factors that should be considered related to how current health care entities are organized, how they function or how legal duties and responsibilities attach to entities that make up an umbrella organization? • Would this change address concerns related to research? • Are there specific privacy concerns associated with expanding the authority or releasing data to qualified VerDate Mar<15>2010 17:57 May 09, 2014 Jkt 232001 researchers/research organizations in this way? • Are there additional use cases that should be considered in the research context? g. Addressing Potential Issues With Electronic Prescribing and Prescription Drug Monitoring Programs (PDMPs) Part 2 protections include a prohibition on the redisclosure of information received directly from a Part 2 program. A pharmacy that receives electronic prescription information directly from a Part 2 program must obtain patient consent to send that information to a PDMP, and patient consent is also required for the PDMP to redisclose that information to those with access to the PDMP. Pharmacy data systems do not currently have mechanisms for managing patient consent or segregating data that are subject to Part 2 and preventing the data from reaching the PDMP. Pharmacy systems also lack the ability to identify which providers are subject to Part 2, making it difficult to prevent the Part 2 data from reaching the PDMP. If a patient does not consent to sharing their data via e-prescribing, their only option for filling their prescription is to bring a paper prescription to the pharmacy. In this instance, since the information is given by the patient, it is not protected by 42 CFR Part 2. They, therefore, cannot prevent the information from reaching the PDMP which in some states is accessible by law enforcement and has the potential to lead to investigation/ arrest and other forms of discrimination. • How do pharmacy information system vendors anticipate addressing this issue? Are there specific technology PO 00000 Frm 00063 Fmt 4702 Sfmt 9990 barriers SAMHSA should take into consideration? • Are there other concerns regarding 42 CFR Part 2 and PDMPs? Please describe relevant use cases and provide recommendations on how to address the concerns. • Are there patient concerns about the impact of e-prescribing and PDMPs on their privacy? Draft Agenda for the June 11, 2014 Public Listening Session —Welcome and Introductions—9:30 a.m.–9:45 a.m. —Applicability of 42 CFR Part 2—9:45 a.m.–10:45 a.m. —Consent requirements—10:45 a.m.– 11:45 a.m. —Redisclosure and Medical emergency provisions—11:45 a.m.–12:45 p.m. —LUNCH (on your own)—12:45 p.m.– 1:15 p.m. —Quality Service Organization (QSO) provision—1:15 p.m.–1:45 p.m. —Research—1:45 p.m.–2:45 p.m. —Electronic prescribing and prescription drug monitoring programs (PDMPs)—2:45 p.m.–3:30 p.m. —Open Comment Period—3:30 p.m.– 4:30 p.m. The agenda will be strictly followed; participants may attend all or part of the listening session as relevant. The updated agenda will be posted on the SAMHSA Web site at https:// www.samhsa.gov/healthprivacy in advance of the listening session. Cathy J. Friedman, SAMHSA Public Health Analyst. [FR Doc. 2014–10913 Filed 5–9–14; 8:45 am] BILLING CODE 4162–20–P E:\FR\FM\12MYP1.SGM 12MYP1

Agencies

[Federal Register Volume 79, Number 91 (Monday, May 12, 2014)]
[Proposed Rules]
[Pages 26929-26932]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-10913]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration

42 CFR Part 2


Confidentiality of Alcohol and Drug Abuse Patient Records

AGENCY: Substance Abuse and Mental Health Services Administration, HHS.

ACTION: Notice of Public Listening Session.

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

SUMMARY: The Substance Abuse and Mental Health Services Administration 
(SAMHSA) announces that it will hold a public listening session on 
Wednesday, June 11, 2014, to solicit information concerning the 
Confidentiality of Alcohol and Drug Abuse Patient Records Regulations, 
42 CFR Part 2. This session will be held in Rockville, MD, to obtain 
direct input from stakeholders on updating the regulations. The 
scheduled listening session provides an opportunity for SAMHSA to seek 
public input on potential changes to the regulations.

[[Page 26930]]


DATES: The listening session will be held on Wednesday, June 11, 2014, 
from 9:30 a.m. to 4:30 p.m.

ADDRESSES: Participation: The listening session will be held at the 
Substance Abuse and Mental Health Services Administration at 1 Choke 
Cherry Road, Rockville, MD 20857, Lobby-level Sugarloaf Conference 
Room.
    SAMHSA will post the agenda and logistical information on how to 
participate via the phone or internet on the SAMHSA Web site at https://www.samhsa.gov/healthprivacy in advance of the listening session.
    The session is open to the public and the entire day's proceedings 
will be webcast, recorded, and made publicly available. Interested 
parties may participate in person or via webcast. Capacity is limited 
and registration is required. To register, go to https://42cfrpart2-listeningsession.eventbrite.com. Registration will be open until we 
meet maximum capacity. In addition to attending the session in person 
and joining via webinar, the Agency offers several ways to provide 
comments, as enumerated below. The forum will begin with opening 
remarks from the SAMHSA official charged with moderating the session. 
The session location is accessible to persons with disabilities.
    You may submit comments using any of the following methods:
     Mail: The Substance Abuse and Mental Health Services 
Administration, 1 Choke Cherry Road, Rockville, MD 20857, Room 5-1011.
     Hand Delivery or Courier: 1 Choke Cherry Road, Rockville, 
MD 20857, Room 5-1011 between 9 a.m. and 5 p.m., ET, Monday through 
Friday, except federal holidays.
     Email: PrivacyRegulations@SAMHSA.hhs.gov.
     Fax: 1-240-276-2900.
    Each submission must include the Agency name and the docket number 
for this notice. Comments must be received by 5:00 p.m. ET on Wednesday 
June 25, 2014.

FOR FURTHER INFORMATION CONTACT: For information concerning the 
listening session or the live webcast, please contact Kate Tipping, 
Public Health Advisor, SAMHSA, 1 Choke Cherry Road, Rockville, MD 
20857, Room 5-1011, (240) 276-1652 or email 
PrivacyRegulations@SAMHSA.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    The federal statute (United States Code, Title 42, section 290dd-2) 
governing the confidentiality of substance abuse treatment information 
guarantees the confidentiality of information for persons receiving 
substance abuse treatment services from federally assisted programs. 
Under the statute, a federally assisted substance abuse program 
generally may only release identifiable information related to 
substance abuse treatment services with the individual's express 
consent. The federal regulations that implement this law--Title 42 of 
the Code of Federal Regulations Part 2 (42 CFR Part 2)--were last 
updated in 1987. Over the last 25 years, significant changes have 
occurred within the U.S. health care system that were not envisioned by 
these regulations, including new models of integrated care that are 
built on a foundation of information sharing to support coordination of 
patient care, the development of an electronic infrastructure for 
managing and exchanging patient data, the development of prescription 
drug monitoring programs and a new focus on performance measurement 
within the health care system. When the regulations were written, 
substance abuse treatment was primarily conducted by specialty 
treatment providers, and as a result, the impact on coordination of 
care was not raised as a core issue.
    SAMHSA has heard from stakeholders that some of the current consent 
requirements make it difficult for these new health care organizations 
including health information exchange organizations (HIEs), Accountable 
Care Organizations (ACOs), and others to share substance abuse 
treatment information. A number of organizations across the country are 
excluding substance abuse treatment data due to the difficulty and 
expense of implementing the functionality and workflow changes 
necessary to comply with current regulations. In these instances, 
patients are prevented from fully participating in integrated care 
efforts even if they are willing to provide consent.
    Behavioral health is essential to overall health and the costs of 
untreated substance abuse disorders, both personal and societal, are 
enormous. However, treatment for substance abuse disorders is still 
associated with discrimination. In addition, there may be potential 
serious civil and criminal consequences for the disclosure of this 
information beyond the health care context. There continues to be a 
need for confidentiality protections that encourage patients to seek 
treatment without fear of compromising their privacy. SAMHSA strives to 
facilitate information exchange while respecting the legitimate privacy 
concerns of patients due to the potential for discrimination and legal 
consequences. We hope to clarify the requirements associated with 
information exchange in these new models and reduce burdens associated 
with specific consent requirements that do not serve to protect patient 
privacy.
    In consideration of the concerns raised regarding the application 
of 42 CFR Part 2 to new health care models and the continued need for 
confidentiality protections, the Agency will conduct a public listening 
session to provide all interested parties the opportunity to share 
their views on the subject prior to the initiation of rulemaking. 
Members of the public are invited to attend and view the proceedings, 
with space available on a first-come, first-served basis (based on 
registration). Written comments may also be submitted at the session or 
through the process described above.
    SAMHSA asks listening session participants to consider the 
following questions in preparing to make comments at the listening 
session. Listening session attendees will also be provided with a list 
of these questions at the forum site:

a. Applicability of 42 CFR Part 2

    42 CFR Part 2 currently applies to federally funded individuals or 
entities that ``hold themselves out as providing, and provide, alcohol 
or drug abuse diagnosis, treatment or treatment referral'' including 
units within a general medical facility that hold themselves out as 
providing diagnosis, treatment or treatment referral (Sec.  2.11 
Definitions, Program). The U.S. health care system is changing and more 
substance abuse treatment is occurring in general health care and 
integrated care settings which are typically not covered under the 
current regulations. It has also posed difficulties for identifying 
which providers are covered by Part 2; whether a provider or 
organization is covered by Part 2 can change depending on whether they 
advertise their substance abuse treatment services (i.e. `hold 
themselves out'), which can change over time.
    SAMHSA is considering options for defining what information is 
covered under 42 CFR Part 2. Covered information could be defined based 
on what substance abuse treatment services are provided instead of 
being defined by the type of facility providing the services. For 
example, the regulations could be applied to any federally assisted 
health care provider that provides a patient with specialty substance 
abuse treatment services. In

[[Page 26931]]

this scenario, providers would not be covered if they provided only 
substance abuse screening, brief intervention, or other similar pre-
treatment substance abuse services.
     How would redefining the applicability of 42 CFR Part 2 
impact patients, health care provider organizations, HIEs, CCOs, HIT 
vendors, etc.?
     Would this change address stakeholder concerns?
     Would this change raise any new concerns?

b. Consent Requirements

    SAMHSA has heard a number of concerns from individuals and 
stakeholders regarding the current consent requirements of 42 CFR Part 
2. 42 CFR 2.31 requires the written consent to include the name or 
title of the individual or the name of the organization to which the 
disclosure is to be made. This is commonly referred to as the ``To 
Whom'' consent requirement. Some stakeholders have reported that this 
requirement makes it difficult to include programs covered by 42 CFR 
Part 2 in HIEs, health homes, ACOs and CCOs. These organizations have a 
large and growing number of member providers and they generally do not 
have sophisticated consent management capabilities. Currently, a Part 2 
compliant consent cannot include future un-named providers which 
requires the collection of updated consent forms whenever new providers 
join these organizations. As a result, many of these organizations are 
currently not including substance abuse treatment information in their 
systems.
    While technical solutions for managing consent collection are 
possible, SAMHSA is examining the consent requirements in Sec.  2.31 to 
explore options for facilitating the flow of information within the 
health care context while ensuring the patient is fully informed and 
the necessary protections are in place. Specifically, we are analyzing 
the current requirements and considering the impact of adapting them 
to:
    1. Allow the consent to include a more general description of the 
individual, organization, or health care entity to which disclosure is 
to be made.
    2. Require the patient be provided with a list of providers or 
organizations that may access their information, and be notified 
regularly of changes to the list.
    3. Require the consent to name the individual or health care entity 
permitted to make the disclosure.
    4. Require that if the health care entity permitted to make the 
disclosure is made up of multiple independent units or organizations 
that the unit, organization, or provider releasing substance abuse 
related information be specifically named.
    5. Require that the consent form explicitly describe the substance 
abuse treatment information that may be disclosed.
    SAMHSA welcomes comments on patient privacy concerns as well as the 
anticipated impact of the consent requirements on integration of 
substance abuse treatment data into HIEs, health homes, ACOs, and CCOs.
     Would these changes maintain the privacy protections for 
patients?
     Would these changes address the concerns of HIEs, health 
homes, ACOs, and CCOs?
     Would these changes raise any new concerns?

c. Redisclosure

    SAMHSA has also heard numerous concerns regarding the prohibition 
on redisclosure (Sec.  2.32). Currently most EHRs don't support data 
segmentation. Without this functionality, EHR systems must either keep 
alcohol and drug abuse patient records separate from the rest of the 
patient's medical record or apply the 42 CFR Part 2 protections to the 
patient's entire medical record if such record contains information 
that is subject to 42 CFR Part 2.
    SAMHSA is considering revising the redisclosure provision to 
clarify that the prohibition on redisclosure only applies to 
information that would identify an individual as a substance abuser, 
and allows other health-related information shared by the Part 2 
program to be redisclosed, if legally permissible. This would allow HIT 
systems to more easily identify information that is subject to the 
prohibition on redisclosure enabling them to utilize other 
technological approaches to manage redisclosure. If data are associated 
with information about where the data were collected (data provenance) 
which reveals that the data were collected by a practice that 
exclusively treats addiction, the data would still be protected under 
the proposed change.
     Would this type of change facilitate technical solutions 
for complying with 42 CFR Part 2 in an EHR or HIE environment?
     Would these changes maintain the privacy protections for 
patients?

d. Medical Emergency

    SAMHSA has heard concerns regarding the medical emergency exception 
of 42 CFR Part 2 (Sec.  2.51). The current regulations state that 
information may be disclosed without consent ``for the purpose of 
treating a condition which poses an immediate threat to the health of 
any individual and which requires immediate medical intervention.'' The 
statute, however, states that records may be disclosed to medical 
personnel to the extent necessary to meet a bona fide medical 
emergency. SAMHSA is considering adapting the medical emergency 
exception to make it more in-line with the statutory language and to 
give providers more discretion as to when a bona fide emergency exists. 
For example, amending this standard to allow providers to use the 
medical emergency provision to prevent emergencies or to share 
information with a detoxification center when a patient is unable to 
provide informed consent due to their level of intoxication.
     What factors should providers take into consideration in 
determining whether a medical emergency exists?
     Are there specific use cases SAMHSA should take into 
consideration?
     Are there patient concerns about the impact of this change 
on their privacy?

e. Qualified Service Organization (QSO)

    SAMHSA has also heard concerns from payers and health management 
organizations related to disclosing information that is subject to 42 
CFR Part 2 to health care entities (ACOs/CCOs) for the purpose of care 
coordination and population health management; helping them to identify 
patients with chronic conditions in need of more intensive outreach. 
Under the current regulations, substance abuse information may not be 
shared for these purposes without consent.
    SAMHSA is analyzing the regulations to identify options for 
allowing Part 2 data to flow to health care entities for the purpose of 
care coordination and population management while maintaining patient 
protections. One potential solution includes expanding the definition 
of a qualified service organization (QSO; Sec.  2.11) to explicitly 
include care coordination services and to allow a QSO Agreement (QSOA) 
to be executed between an entity that stores Part 2 information, such 
as a payer or an ACO that is not itself a Part 2 program, and a service 
provider.
     Are there other use cases we should be taking into 
consideration?
     Are there specific patient concerns about the impact of 
this change on their privacy?

[[Page 26932]]

f. Research

    Under the current regulations, the Part 2 ``program director'' has 
to authorize the release of information for scientific research 
purposes. This issue has been brought to SAMHSA's attention from 
organizations that store patient health data, including data that are 
subject to Part 2, which may be used for research (e.g. health 
management organizations). Under the current regulatory framework, 
absent consent, these organizations do not have the authority to 
disclose Part 2 data for scientific research purposes to qualified 
researchers or research organizations. This issue can be addressed by 
expanding the authority for releasing data to qualified researchers/
research organizations to other health care entities that receive and 
store Part 2 data, including third-party payers, HIEs, and care 
coordination organizations for the purposes of research, audit, or 
evaluation.
    SAMHSA is considering expanding the authority for releasing data to 
qualified researchers/research organizations to health care entities 
that receive and store Part 2 data, including third-party payers, 
health management organizations, HIEs, and care coordination 
organizations.
     Are there factors that should be considered related to how 
current health care entities are organized, how they function or how 
legal duties and responsibilities attach to entities that make up an 
umbrella organization?
     Would this change address concerns related to research?
     Are there specific privacy concerns associated with 
expanding the authority or releasing data to qualified researchers/
research organizations in this way?
     Are there additional use cases that should be considered 
in the research context?

g. Addressing Potential Issues With Electronic Prescribing and 
Prescription Drug Monitoring Programs (PDMPs)

    Part 2 protections include a prohibition on the redisclosure of 
information received directly from a Part 2 program. A pharmacy that 
receives electronic prescription information directly from a Part 2 
program must obtain patient consent to send that information to a PDMP, 
and patient consent is also required for the PDMP to redisclose that 
information to those with access to the PDMP. Pharmacy data systems do 
not currently have mechanisms for managing patient consent or 
segregating data that are subject to Part 2 and preventing the data 
from reaching the PDMP. Pharmacy systems also lack the ability to 
identify which providers are subject to Part 2, making it difficult to 
prevent the Part 2 data from reaching the PDMP.
    If a patient does not consent to sharing their data via e-
prescribing, their only option for filling their prescription is to 
bring a paper prescription to the pharmacy. In this instance, since the 
information is given by the patient, it is not protected by 42 CFR Part 
2. They, therefore, cannot prevent the information from reaching the 
PDMP which in some states is accessible by law enforcement and has the 
potential to lead to investigation/arrest and other forms of 
discrimination.
     How do pharmacy information system vendors anticipate 
addressing this issue? Are there specific technology barriers SAMHSA 
should take into consideration?
     Are there other concerns regarding 42 CFR Part 2 and 
PDMPs? Please describe relevant use cases and provide recommendations 
on how to address the concerns.
     Are there patient concerns about the impact of e-
prescribing and PDMPs on their privacy?

Draft Agenda for the June 11, 2014 Public Listening Session

--Welcome and Introductions--9:30 a.m.-9:45 a.m.
--Applicability of 42 CFR Part 2--9:45 a.m.-10:45 a.m.
--Consent requirements--10:45 a.m.-11:45 a.m.
--Redisclosure and Medical emergency provisions--11:45 a.m.-12:45 p.m.
--LUNCH (on your own)--12:45 p.m.-1:15 p.m.
--Quality Service Organization (QSO) provision--1:15 p.m.-1:45 p.m.
--Research--1:45 p.m.-2:45 p.m.
--Electronic prescribing and prescription drug monitoring programs 
(PDMPs)--2:45 p.m.-3:30 p.m.
--Open Comment Period--3:30 p.m.-4:30 p.m.

    The agenda will be strictly followed; participants may attend all 
or part of the listening session as relevant. The updated agenda will 
be posted on the SAMHSA Web site at https://www.samhsa.gov/healthprivacy 
in advance of the listening session.

Cathy J. Friedman,
SAMHSA Public Health Analyst.
[FR Doc. 2014-10913 Filed 5-9-14; 8:45 am]
BILLING CODE 4162-20-P