Press Release
Phone/Fax: 1 (212) 595-NAMA (1-212-595-6262)
For Release:
September 16, 2019
Confidently
Under Attack
(We Are in for the
Fight of Our Lives)
SAMHSA has
posted two notices of proposed rulemaking (“NPRMs”) on the federal regulations
for the Confidentiality of Substance Use Disorder Patient Records.
They were
published August 26, 2019 in the Federal Register. Note the comment deadlines for
each rule:
NPRM –
Regulatory Information Number 0930-AA30:
Deadline for submitting public comments: by 5 pm
September 25, 2019
NPRM –
Regulatory Information Number 0930-AA32:
Deadline for submitting public
comments: by 5
pm October 25, 2019
Number 0930-AA30 public comments
must be submitted by September 25, 2019 by 5 pm.
Here is
a summary of the main changes that are acceptable:
Consent
Requirements: Patients may consent to release without naming a specific
person to apply for benefits and resources (i.e. SSI)
Disclosures Permitted w/
Written Consent: Payment and health care
operations are permitted with written consent.
Medical
Emergencies: Patient information may be released during declared
emergencies without consent.
Audit
and Evaluation: To resolve current ambiguity, part 2 will be
revised to clarify some situations that fall within the scope.
Here is
a summary of the main changes that are NOT acceptable:
Applicability
and Re-Disclosure: Patient’s records in non-part
2 providers both previous and current are no longer covered.
NAMA-R thinks this is unacceptable and that Part 2 records
needs to maintain the protection that they have always had.
Disposition
of Records: Part 2 program employees may delete a patient message sent
to them on their personal device.
NAMA-R does not believe Part 2 employees should be using
their personal devices for program business. Part 2 programs should set aside the
funds to purchase mobile phones for employees.
Disclosures
to Central Registries and PDMPs: Non-OTP providers may
query a Central Registry to determine if patients are receiving opioid
treatment elsewhere. OTPs will be permitted to enroll in PDMPs when prescribing
Schedule II to V, consistent with applicable state law.
NAMA-R believes Central Registries are an
important part of the treatment system, as they have been for over 40 years,
and can be utilized in ways that protect Confidentiality. However, reporting medication dispensed by
OTPs to state prescription drug monitoring programs (PDMPs) would violate the
specific consent requirements of 42 USC 290dd-2. Furthermore, it gives criminal
justice agencies access to persons involved in substance use treatment. This could discourage individuals with OUD
from seeking treatment. Law
enforcement accesses PDMPs at a very high frequency. Many states do not require
a warrant or subpoena for law enforcement access of this highly sensitive
information. This is a very low bar.
Research:
Research may be conducted by HIPAA entities or
business associate to individuals and organizations who are not HIPAA entities,
nor subject to the Common Rule (re: Research on Human Subjects).
NAMA-R supports research involving
patients of SUD treatment as long as confidentiality protections remain in
place. These proposed changes will allow research into OTPs in a way that opens
the door for entities to do marketing research and otherwise violate a
patient’s civil right to confidentiality.
Confidential
Communications: To correct an error from the 2017 rule-making,
the “standard for court ordered disclosures of SUD records for the purpose of investigating
"an extremely serious crime" will be revised, by dropping the phrase
"allegedly committed by the patient."
NAMA-R opposes the proposed changes to this
section. For over forty years, Part 2 has protected people who have sought
treatment for alcohol and drug use from having their own records used against
them in courts, unless it is a case of serious violence or child abuse. It has
never been intended that our SUD treatment records be used in cases
of "drug trafficking" against a patient, or another person. People
seek treatment to recover from substance use disorders, to change their lives,
and believe that the private information they share will be confidential
and protected. One must recall that Part 2 was implemented over a murder
that a community person thought was committed by a patient at an OTP. The
community member was wrong.
Undercover
Agents and Informants: Court-ordered placement of an undercover agent
or informant within a part 2 program will be extended to a period of 12 months,
and courts will be authorized to extend the period through a new court order.
NAMA-R believes that there is no
place for informants in Part 2 programs. Allowing this will frighten
prospective patients from treatment during a time of crisis and will obliterate
the confidentiality protections required by 42 USC 290dd-2.
SAMHSA does not have the authority to implement regulations
that override the U.S. Code and legislation passed by Congress and signed by
the President. Only Congress and the President can change legislative
requirements enshrined in the U.S. Code. SAMHSA, as an Executive Branch agency,
does not have the Constitutional authority to implement changes in 42 CFR Part
2 that override or otherwise attempt to invalidate core requirements and
provisions of 42 USC 290dd-2.
In context
of pervasive stigma and criminalization, patients need MORE privacy protections
for people who use drugs, not less. Better integration between behavioral,
mental, and other health info is necessary to improve care. Giving up privacy
to get there is not a necessary trade-off.
The PDMP
provision is a MAJOR fundamental change that threatens the essential framework
of 42 CFR Part 2 and likely would result in unconstitutional executive
overreach by SAMHSA that would override consent requirements required by 42 USC
290dd-2.
When an
individual seeks treatment, they are acknowledging highly stigmatized and criminalized
behavior. Drug use is subject to enormous negative consequences, including
criminal liability, parental rights, housing, life insurance and other benefits.
Confidentiality currently afforded by 42 CFR Part 2 protects patients from this
discrimination.
The major
function of Part 2 is to create relatively high bar on data access for law
enforcement to assuage patient concerns about surveillance and their
information being used against them. HIPAA provides no patient protection
against law enforcement access of SUD treatment records.
What Should You Do?
What to Expect
This
is called a New Proposed Rule Making (NPRM). The agency that oversees the
regulations begins by posting a Comment Period.
Usually it is 90 days to give everyone the opportunity to write their
comments. SAMHSA only gave 30 days
for Regulatory Information Number
0930-AA30 and 60 days for Regulatory
Information Number 0930-AA32. The standard has always been a 90
day public commenting period, especially when there are significant changes.
Links to the pdf file proposing the
NPRMs is at the beginning and comments can be submitted there.
Everyone that is a patient or an
advocate for patients should comment. You can copy from this Press Release or
write your own. And your comment can be as simple as:
“I am a patient (or advocate for
patients) and this NPRM should not be implemented. Patients in Part 2 programs
have been promised that their information is protected. What will they be told
if these changes are made? These changes
are significant enough to make any therapeutic alliance between patients and
Part 2 programs difficult.
Patients need MORE protection.
Signed Your Name”
Additional support around commenting
with a direct hyperlink to the commenting website, as well as specifics between
the two NRPMs, can be found here:
If you are concerned about signing
your name you could write, “I am afraid to sign my name because of the
discrimination I’ve experienced.”
More Information:
The Fundamentals of Part 2 (Legal Action Center)
SAMHSA to Propose Changes to 42 CFR Part 2
Fight for Patient’s Rights - Dr. Westley Clark, MD, JD, MPH and Danielle Tarino, MA
FLYER
CALL TO ACTION
Leave Comment on
SAMHSA’s Confidentiality Proposals
The federal confidentiality
law and regulations protect the privacy of substance use disorder (SUD) patient
records by prohibiting unauthorized disclosures of patient records except in
limited circumstances. Congress enacted the legislation in the 1970s to
encourage individuals with SUDs to enter and remain in treatment. 42 USC § 290dd-2 is the law. The regulations implementing the law are
at 42 CFR (Code of FederalRegulations) Part 2 and are commonly
referred to as “Part 2.” Core protections against law enforcement and
re-disclosure are just as critical today as they were in the 1970s.
PART 2 is UNDER ATTACK. The Trump Administration’s HHS
Secretary Alex Azar and Assistant Secretary for Mental Health and
Substance Use Elinore McCanze-Katz are overseeing two separate
“Notices of Proposed Rule Making” (NPRM) that seek to obliterate the
core confidentiality protections of Part 2. This one pager contains core
concerns around each NPRM with a direct link to leave Public Comment.
NPRM #1: Proposal
0930-AA30 COMMENTS
DUE by 9/25/19 at 5pm Eastern!
- Would allow personal health information to be shared outside the healthcare system for criminal justice purposes & allow law enforcement “fishing expeditions” in patient records to prosecute individuals enrolled in treatment or use patient records to prosecute others;
- This proposed change is not in line with the best interests of patients seeking treatment for substance use disorders, and it goes against the fundamental reason for 42 CFR Part2;
- These changes will deter people from seeking care out of fear of law enforcement involvement & encourage those enrolled in treatment to leave prematurely;
- It has never been intended in any iteration of Part 2 that SUD treatment records be used in cases of "drug trafficking" against a patient, or another person. SAMHSA should not implement these proposed changes that have the potential to worsen the opioid crisis & deter individuals with OUD from seeking treatment.
NPRM #2: Proposal
0930-AA32 COMMENTS
DUE by 10/25/19 at 5pm Eastern!
- Applicability and Re-Disclosure: Patient’s records in non-part 2 providers both previous and current are no longer covered. This is unacceptable, as re-disclosure protections are critical to the core confidentiality protections and purposes of Part 2.
- Disclosures to Central Registries and PDMPs: This is one of the most frightening proposals that would obliterate the consent requirement of 42 USC 290dd-2 and allow any individual with a login to the Prescription Drug Monitoring Program (PDMP) to access information regarding an individual’s SUD treatment without their consent. NO SUD treatment information, including SUD treatment medications, should be uploaded into the PDMP. Law enforcement routinely accesses PDMPs in many states. This issue should not be “kicked” to the states, as core civil rights should always be protected federally.
- Undercover Agents and Informants: Court-ordered placement of an undercover agent or informant within a Part 2 program will be allowed for a period of 12 months. There is no place for informants in SUD treatment programs. Allowing this will frighten prospective & current patients from treatment during a time of crisis and will obliterate the confidentiality protections required by 42 USC 290dd-2.
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