[Congressional Record Volume 164, Number 103 (Wednesday, June 20, 2018)]
[House]
[Pages H5325-H5335]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
OVERDOSE PREVENTION AND PATIENT SAFETY ACT
Mr. BURGESS. Mr. Speaker, pursuant to House Resolution 949, I call up
the bill (H.R. 6082) to amend the Public Health Service Act to protect
the confidentiality of substance use disorder patient records, and ask
for its immediate consideration in the House.
The Clerk read the title of the bill.
The SPEAKER pro tempore. Pursuant to House Resolution 949, an
amendment in the nature of a substitute consisting of the text of Rules
Committee Print 115-75 is adopted, and the bill, as amended, is
considered read.
The text of the bill, as amended, is as follows:
H.R. 6082
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Overdose Prevention and
Patient Safety Act''.
SEC. 2. CONFIDENTIALITY AND DISCLOSURE OF RECORDS RELATING TO
SUBSTANCE USE DISORDER.
(a) Conforming Changes Relating to Substance Use
Disorder.--Subsections (a) and (h) of section 543 of the
Public Health Service Act (42 U.S.C. 290dd-2) are each
amended by striking ``substance abuse'' and inserting
``substance use disorder''.
(b) Disclosures to Covered Entities Consistent With
HIPAA.--Paragraph (2) of section 543(b) of the Public Health
Service Act (42 U.S.C. 290dd-2(b)) is amended by adding at
the end the following:
``(D) To a covered entity or to a program or activity
described in subsection (a), for the purposes of treatment,
payment, and health care operations, so long as such
disclosure is made in accordance with HIPAA privacy
regulation. Any redisclosure of information so disclosed may
only be made in accordance with this section.''.
(c) Disclosures of De-identified Health Information to
Public Health Authorities.--Paragraph (2) of section 543(b)
of the Public Health Service Act (42 U.S.C. 290dd-2(b)), as
amended by subsection (b), is further amended by adding at
the end the following:
``(E) To a public health authority, so long as such content
meets the standards established in section 164.514(b) of
title 45, Code of Federal Regulations (or successor
regulations) for creating de-identified information.''.
(d) Definitions.--Subsection (b) of section 543 of the
Public Health Service Act (42 U.S.C. 290dd-2) is amended by
adding at the end the following:
``(3) Definitions.--For purposes of this subsection:
``(A) Covered entity.--The term `covered entity' has the
meaning given such term for purposes of HIPAA privacy
regulation.
``(B) Health care operations.--The term `health care
operations' has the meaning given such term for purposes of
HIPAA privacy regulation.
[[Page H5326]]
``(C) HIPAA privacy regulation.--The term `HIPAA privacy
regulation' has the meaning given such term under section
1180(b)(3) of the Social Security Act.
``(D) Individually identifiable health information.--The
term `individually identifiable health information' has the
meaning given such term for purposes of HIPAA privacy
regulation.
``(E) Payment.--The term `payment' has the meaning given
such term for purposes of HIPAA privacy regulation.
``(F) Public health authority.--The term `public health
authority' has the meaning given such term for purposes of
HIPAA privacy regulation.
``(G) Treatment.--The term `treatment' has the meaning
given such term for purposes of HIPAA privacy regulation.''.
(e) Use of Records in Criminal, Civil, or Administrative
Investigations, Actions, or Proceedings.--Subsection (c) of
section 543 of the Public Health Service Act (42 U.S.C.
290dd-2) is amended to read as follows:
``(c) Use of Records in Criminal, Civil, or Administrative
Contexts.--Except as otherwise authorized by a court order
under subsection (b)(2)(C) or by the consent of the patient,
a record referred to in subsection (a) may not--
``(1) be entered into evidence in any criminal prosecution
or civil action before a Federal or State court;
``(2) form part of the record for decision or otherwise be
taken into account in any proceeding before a Federal agency;
``(3) be used by any Federal, State, or local agency for a
law enforcement purpose or to conduct any law enforcement
investigation of a patient; or
``(4) be used in any application for a warrant.''.
(f) Penalties.--Subsection (f) of section 543 of the Public
Health Service Act (42 U.S.C. 290dd-2) is amended to read as
follows:
``(f) Penalties.--The provisions of sections 1176 and 1177
of the Social Security Act shall apply to a violation of this
section to the extent and in the same manner as such
provisions apply to a violation of part C of title XI of such
Act. In applying the previous sentence--
``(1) the reference to `this subsection' in subsection
(a)(2) of such section 1176 shall be treated as a reference
to `this subsection (including as applied pursuant to section
543(f) of the Public Health Service Act)'; and
``(2) in subsection (b) of such section 1176--
``(A) each reference to `a penalty imposed under subsection
(a)' shall be treated as a reference to `a penalty imposed
under subsection (a) (including as applied pursuant to
section 543(f) of the Public Health Service Act)'; and
``(B) each reference to `no damages obtained under
subsection (d)' shall be treated as a reference to `no
damages obtained under subsection (d) (including as applied
pursuant to section 543(f) of the Public Health Service
Act)'.''.
(g) Antidiscrimination.--Section 543 of the Public Health
Service Act (42 U.S.C. 290dd-2) is amended by adding at the
end the following:
``(i) Antidiscrimination.--
``(1) In general.--No entity shall discriminate against an
individual on the basis of information received by such
entity pursuant to a disclosure made under subsection (b)
in--
``(A) admission or treatment for health care;
``(B) hiring or terms of employment;
``(C) the sale or rental of housing; or
``(D) access to Federal, State, or local courts.
``(2) Recipients of federal funds.--No recipient of Federal
funds shall discriminate against an individual on the basis
of information received by such recipient pursuant to a
disclosure made under subsection (b) in affording access to
the services provided with such funds.''.
(h) Notification in Case of Breach.--Section 543 of the
Public Health Service Act (42 U.S.C. 290dd-2), as amended by
subsection (g), is further amended by adding at the end the
following:
``(j) Notification in Case of Breach.--
``(1) Application of hitech notification of breach
provisions.--The provisions of section 13402 of the HITECH
Act (42 U.S.C. 17932) shall apply to a program or activity
described in subsection (a), in case of a breach of records
described in subsection (a), to the same extent and in the
same manner as such provisions apply to a covered entity in
the case of a breach of unsecured protected health
information.
``(2) Definitions.--In this subsection, the terms `covered
entity' and `unsecured protected health information' have the
meanings given to such terms for purposes of such section
13402.''.
(i) Sense of Congress.--It is the sense of the Congress
that any person treating a patient through a program or
activity with respect to which the confidentiality
requirements of section 543 of the Public Health Service Act
(42 U.S.C. 290dd-2) apply should access the applicable State-
based prescription drug monitoring program as a precaution
against substance use disorder.
(j) Regulations.--
(1) In general.--The Secretary of Health and Human
Services, in consultation with appropriate Federal agencies,
shall make such revisions to regulations as may be necessary
for implementing and enforcing the amendments made by this
section, such that such amendments shall apply with respect
to uses and disclosures of information occurring on or after
the date that is 12 months after the date of enactment of
this Act.
(2) Easily understandable notice of privacy practices.--Not
later than 1 year after the date of enactment of this Act,
the Secretary of Health and Human Services, in consultation
with appropriate experts, shall update section 164.520 of
title 45, Code of Federal Regulations, so that covered
entities provide notice, written in plain language, of
privacy practices regarding patient records referred to in
section 543(a) of the Public Health Service Act (42 U.S.C.
290dd-2(a)), including--
(A) a statement of the patient's rights, including self-pay
patients, with respect to protected health information and a
brief description of how the individual may exercise these
rights (as required by paragraph (b)(1)(iv) of such section
164.520); and
(B) a description of each purpose for which the covered
entity is permitted or required to use or disclose protected
health information without the patient's written
authorization (as required by paragraph (b)(2) of such
section 164.520).
(k) Development and Dissemination of Model Training
Programs for Substance Use Disorder Patient Records.--
(1) Initial programs and materials.--Not later than 1 year
after the date of the enactment of this Act, the Secretary of
Health and Human Services (referred to in this subsection as
the ``Secretary''), in consultation with appropriate experts,
shall identify the following model programs and materials (or
if no such programs or materials exist, recognize private or
public entities to develop and disseminate such programs and
materials):
(A) Model programs and materials for training health care
providers (including physicians, emergency medical personnel,
psychiatrists, psychologists, counselors, therapists, nurse
practitioners, physician assistants, behavioral health
facilities and clinics, care managers, and hospitals,
including individuals such as general counsels or regulatory
compliance staff who are responsible for establishing
provider privacy policies) concerning the permitted uses and
disclosures, consistent with the standards and regulations
governing the privacy and security of substance use disorder
patient records promulgated by the Secretary under section
543 of the Public Health Service Act (42 U.S.C. 290dd-2), as
amended by this section, for the confidentiality of patient
records.
(B) Model programs and materials for training patients and
their families regarding their rights to protect and obtain
information under the standards and regulations described in
subparagraph (A).
(2) Requirements.--The model programs and materials
described in subparagraphs (A) and (B) of paragraph (1) shall
address circumstances under which disclosure of substance use
disorder patient records is needed to--
(A) facilitate communication between substance use disorder
treatment providers and other health care providers to
promote and provide the best possible integrated care;
(B) avoid inappropriate prescribing that can lead to
dangerous drug interactions, overdose, or relapse; and
(C) notify and involve families and caregivers when
individuals experience an overdose.
(3) Periodic updates.--The Secretary shall--
(A) periodically review and update the model programs and
materials identified or developed under paragraph (1); and
(B) disseminate such updated programs and materials to the
individuals described in paragraph (1)(A).
(4) Input of certain entities.--In identifying, reviewing,
or updating the model programs and materials under this
subsection, the Secretary shall solicit the input of relevant
stakeholders.
(l) Rules of Construction.--Nothing in this Act or the
amendments made by this Act shall be construed to limit--
(1) a patient's right, as described in section 164.522 of
title 45, Code of Federal Regulations, or any successor
regulation, to request a restriction on the use or disclosure
of a record referred to in section 543(a) of the Public
Health Service Act (42 U.S.C. 290dd-2(a)) for purposes of
treatment, payment, or health care operations; or
(2) a covered entity's choice, as described in section
164.506 of title 45, Code of Federal Regulations, or any
successor regulation, to obtain the consent of the individual
to use or disclose a record referred to in such section
543(a) to carry out treatment, payment, or health care
operation.
(m) Sense of Congress.--It is the sense of the Congress
that--
(1) patients have the right to request a restriction on the
use or disclosure of a record referred to in section 543(a)
of the Public Health Service Act (42 U.S.C. 290dd-2(a)) for
treatment, payment, or health care operations; and
(2) covered entities should make every reasonable effort to
the extent feasible to comply with a patient's request for a
restriction regarding such use or disclosure.
The SPEAKER pro tempore. The bill, as amended, shall be debatable for
1 hour equally divided and controlled by the chair and the ranking
minority member of the Committee on Energy and Commerce.
The gentleman from Texas (Mr. Burgess) and the gentleman from New
Jersey (Mr. Pallone) each will control 30 minutes.
The Chair recognizes the gentleman from Texas.
General Leave
Mr. BURGESS. Mr. Speaker, I ask unanimous consent that all Members
may have 5 legislative days within which to revise and extend their
remarks and insert extraneous material on H.R. 6082.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Texas?
There was no objection.
Mr. BURGESS. Mr. Speaker, I yield myself such time as I may consume.
[[Page H5327]]
Mr. Speaker, over the course of the past several months, the Energy
and Commerce's Subcommittee on Health held four legislative hearings on
bills to address the opioid epidemic and reported 57 bills to the full
committee. Of those 57 bills, only one received its own discrete
hearing. That bill was H.R. 6082, the Overdose Prevention and Patient
Safety Act, introduced by Representatives Mullin and Blumenauer.
{time} 1245
As a physician, I believe it is vital that doctors have all of the
appropriate information to determine the proper course of treatment for
a patient, ensuring patient safety and privacy, as required by Federal
regulation known as HIPAA. The Overdose Prevention and Patient Safety
Act maintains the original intent of the 1970s statute behind 42 CFR
part 2 by protecting patients and improving care coordination.
In fact, the bill increases protections for those seeking treatment
by more severely penalizing those who illegally share patient data than
under the current statute. Current part 2 law does not protect
individuals from discrimination based on their treatment records and,
to this date, there have been no criminal actions undertaken to enforce
part 2.
This bill has a wide range of support from national and State
organizations. Since the bill was introduced, the Energy and Commerce
Committee has heard from over 100 organizations in its support.
Arguably, the most notable support for this legislation comes from
the Substance Abuse and Mental Health Services Administration in the
Department of Health and Human Services. Dr. Elinore McCance-Katz, the
Assistant Secretary for Mental Health and Substance Use, wrote to Mr.
Mullin in March, stating that SAMHSA ``is encouraged to see Congress
examine the benefits of aligning part 2 with HIPAA. Patient privacy is,
of course, critical but so too is patient access to safe, effective,
and coordinated treatment.''
I agree with Dr. McCance-Katz that in order to ensure patient safety,
physicians must have secure access to patient records, including
substance use disorder information. When this information is not
provided to healthcare professionals, they may end up prescribing
medications that have dangerous drug interactions or may lead a patient
who is in recovery to be inappropriately prescribed an opioid and fall
back into addiction.
One particular complication driven by 42 CFR part 2 directly impacts
the care for pregnant women and their infants. For women who are
pregnant, part 2 does not allow redisclosure of substance use disorder
medical documentation to the women's OB/GYN doctor, primary care
physician, or health home without their written consent. This leads to
fragmented care, which opens up the mother and her baby to potential
harm.
Centerstone, one of the Nation's largest not-for-profit healthcare
organizations, notes that ``mothers who continue to use during
pregnancy and who do not wish to sign secondary releases to allow their
care providers to treat them comprehensively put their unborn children
at risk for addiction.''
Centerstone watches these women and their infants suffer right before
their eyes, but, because of part 2, Centerstone cannot share the
information to ensure that the mother and baby are getting proper care.
As an OB/GYN physician myself, I cannot imagine having this
information withheld. Such a situation would leave me with the
inability to treat the whole patient and ensure that the mother is
healthy and her baby is not on a path for addiction.
In another situation, a patient was referred to a treatment center
following an emergency room visit for an overdose. The patient was not
able to give written consent to his providers due to acute
intoxication. Due to a lack of written consent and 42 CFR part 2, the
treatment facility could not communicate to the ER and learn about the
patient's condition or confirm that the patient had, indeed, enrolled
in a drug treatment center, further delaying critical care
coordination.
There is clear evidence that part 2 is a massive roadblock to
providing safe, quality, and coordinated care to individuals suffering
from substance use disorder.
The issue of the stigma associated with substance use disorder has
been a constant in all of the discussions that we have had, both in our
offices and in our hearings. In April, we heard from numerous
individuals who were parents of children who died from opioid
overdoses. Some noted that their children were afraid to seek help from
their families or from healthcare professionals because they were
embarrassed or they felt stigmatized.
We should enable physicians to fully care for these patients
suffering from substance use disorder as if they had any other disease.
The Overdose Prevention and Patient Safety Act will do just that.
The first step in addressing a problem is admitting that it exists. I
would like to pose a question to those who are arguing against this
legislation:
If we continue to silo the substance use disorder treatment
information of a select group of patients rather than integrating it
into our medical records and comprehensive care models, how can we
ensure that these patients are, in fact, receiving quality care? How
can we really treat substance use disorder like all other complex
health conditions?
H.R. 6082 ensures adequate patient data protection in accordance with
Federal law, with HIPAA. There are provisions in the language that
ensure that the data may only be used for purposes of treatment,
payment, or healthcare operations. Substance use disorder data cannot
be used in criminal, civil, or administrative investigations, actions,
or proceedings without patient consent or a court order.
Additionally, the legislation explicitly prohibits discrimination
against an individual on the basis of their patient needs. Currently,
part 2 includes no antidiscrimination protections and no protections
for individuals if there is a data breach or improper disclosure.
Think about that for a minute, Mr. Speaker. This was a 1970s-era law.
There were not data breaches back in the 1970s. 42 CFR part 2 was never
intended to protect a patient in the instance of a data breach.
Should any entity or individual share patient data under H.R. 6082,
they, in fact, will be severely penalized.
There is a reason why SAMHSA and most of the healthcare stakeholder
community is asking for this change. Clearly, there is an issue here
that must be addressed. This opioid crisis is devastating our country.
Passing the Overdose Prevention and Patient Safety Act will enable
greater coordination among healthcare providers in providing quality,
effective care for individuals across the country who are battling
substance use disorder.
My thanks to Mr. Mullin on the Energy and Commerce Committee and to
Mr. Blumenauer for introducing this legislation that is of utmost
importance.
I urge strong support for the bill, and I reserve the balance of my
time.
Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise in opposition to H.R. 6082, the Overdose
Prevention and Patient Safety Act. This legislation would greatly harm
our efforts to combat the opioid epidemic. If we really want to turn
the tide on this crisis, we must find ways to get more people into
treatment for opioid use disorder.
In 2016, there were about 21 million Americans aged 12 or older in
need of substance use disorder treatment, but only 4 million of those
21 million actually received treatment. That means 17 million people
are going without the treatment they need. Failure to get individuals
with opioid use disorder into treatment increases risk of fatal and
nonfatal overdoses as people continue to seek out illicit opioids as
part of their addiction. The increasing presence of fentanyl in our
drug supply only heightens this concern.
Strategies that increase the number of people getting into and
remaining in treatment are particularly important because, as these
treatment statistics show, major challenges exist to getting people
with substance use disorders to enter treatment in the first place. And
this House should not--and I stress ``should not''--take any action
that puts at risk people seeking treatment for any substance use
disorder, but particularly opioid use disorders.
Unfortunately, this bill risks doing just that: reducing the number
of people willing to come forward and remain
[[Page H5328]]
in treatment because they worry about the negative consequences that
seeking treatment can have on their lives. And this is a very real
concern.
This bill weakens privacy protections that must be in place for some
people to feel comfortable about starting treatment for their substance
use disorder. Ensuring strong privacy protections is critical to
maintaining an individual's trust in the healthcare system and a
willingness to obtain needed health services, and these protections are
especially important where very sensitive information is concerned.
The information that may be included in the treatment records of a
substance use disorder patient are particularly sensitive because
disclosure of substance use disorder information can create tangible
vulnerabilities that are not the same as other medical conditions. For
example, you are not incarcerated for having a heart attack; you cannot
legally be fired for having cancer; and you are not denied visitation
to your children due to sleep apnea.
According to SAMHSA, the negative consequences that can result from
the disclosure of an individual's substance use disorder treatment
record can include loss of employment, loss of housing, loss of child
custody, discrimination by medical professionals and insurers, arrest,
prosecution, and incarceration. These are real risks that keep people
from getting treatment in the first place.
While I understand that the rollback of the existing privacy
protections to the HIPAA standard would limit permissible disclosures
without patient consent to healthcare organizations, this ignores the
reality: It may be illegal for information to be disclosed outside
these healthcare organizations, but we know, Mr. Speaker, that
information does get out. Breaches do happen.
Remember the recent large-scale Aetna breach that disclosed some of
its members' HIV status?
But there are also small-scale breaches that don't make the news that
can have devastating consequences for patients trying to recover and
get treatment. For example, a recent ProPublica investigation detailed
instances where a healthcare organization's employee peeked at the
record of a patient 61 times and posted details on Facebook, while
another improperly shared a patient's health information with the
patient's parole officer. Breaches such as this are very concerning and
could occur more often as a result of this legislation.
While I appreciate the sponsor's efforts to alleviate these concerns,
I do not believe the potential harm that could be caused by eliminating
the patient consent requirement under existing law for treatment,
payment, and healthcare operations can be remedied through the measures
included in this bill. The inclusion of these provisions cannot
compensate for the risk of stigma, discrimination, and negative health
and life outcomes for individuals with opioid use disorder that could
result from the weakening of the existing privacy protections, and that
is why every substance use disorder patient group has come out in
opposition to this bill.
According to the Campaign to Protect Patient Privacy Rights, a
coalition of more than 100 organizations: ``Using the weaker HIPAA
privacy rule standard of allowing disclosure of substance use disorder
information without patient consent for treatment, payment, and
healthcare operations will contribute to the existing level of
discrimination and harm to people living with substance use
disorders.''
The Campaign goes on to say: ``This will only result in more people
who need substance use disorder treatment being discouraged and afraid
to seek the healthcare they need during the Nation's worst opioid
crisis.''
This is a risk we simply should not take, and yet the majority is
bringing this bill to the floor today, despite the very real concerns
of these experts. These groups uniquely understand what is at stake
from this legislation because many of their members live with or are in
fear of the negative consequences that result from the disclosure of
substance use disorder diagnosis and treatment information.
In fact, the negative consequences that will result from the
disclosure of someone's substance use disorder would solely affect that
individual and their family. They will bear the burden if we get this
wrong. They could be at risk of potentially losing custody of their
child and their freedom by the increased risk of improper disclosure of
their medical record if this bill becomes law.
These risks may simply just keep them from seeking potentially
lifesaving treatment. That is why substance use disorder treatment
providers have also raised concerns.
The South Carolina Association of Opioid Dependence explained: ``Even
with the growing awareness that substance use disorders are a disease,
the unfortunate truth is that persons with substance use disorder are
still actively discriminated against . . . such as a baby being taken
away from a new mother because she is on methadone for an opioid use
disorder, despite longstanding compliance with her treatment and
abstinence from illegal drug use.''
Another provider, Raise the Bottom Addiction Treatment, one of two
medical-assisted treatment facilities in Idaho, explained that ``our
patients come from every walk of life, including professionals and
executives within our community. Their anonymity and privacy is of
utmost importance because their careers, families, and livelihood often
depend on it.
``Knowing that people may seek treatment without fear of backlash and
discrimination is often a deciding factor when considering entering
treatment.
``To undo this protection will deeply affect one's ability and
willingness to seek help. . . . Not only can the members of our
community not afford to lose their right to confidentiality, but we as
a nation cannot afford to move backwards in our fight to combat this
opiate crisis.''
{time} 1300
So again, Mr. Speaker, these are the words of experts on the
frontline fighting this epidemic. People who suffer from substance use
disorder should be able to decide with whom to share their treatment
records from programs and for what purposes. Those rights are taken
away from them under this legislation, and I believe that is wrong.
As we face a tragic national drug abuse problem, the scale of which
our country has never seen, I believe maintaining the heightened
privacy protections under existing law remains vital to ensuring all
individuals with substance use disorder can seek treatment for their
substance use disorder with confidence that their right to privacy will
be protected. To do otherwise at this time is just too great a risk,
and I strongly urge my colleagues to listen to the experts on the
subject and to vote ``no'' on this legislation.
Mr. Speaker, I reserve the balance of my time.
Mr. BURGESS. Mr. Speaker, I yield 3 minutes to the gentleman from
Oklahoma (Mr. Mullin), the principal sponsor of the bill and a valuable
member of the Energy and Commerce Committee.
Mr. MULLIN. Mr. Speaker, I rise today to speak in support of my bill,
H.R. 6082, the Overdose Prevention and Patient Safety Act.
My colleague Mr. Blumenauer and I introduced this bill to help
physicians fight the opioid epidemic. The Overdose Prevention and
Patient Safety Act allows the flow of information among healthcare
providers and health planners for the purpose of treatment, payment,
and healthcare operations.
Unfortunately, there is an outdated Federal Government mandate, 42
CFR part 2, which is creating a firewall between doctors and patients.
My bill, the Overdose Prevention and Patient Safety Act, will give
doctors access to patients' addiction medical information that can
integrate their care, prevent tragic overdoses, and improve patient
safety.
SAMHSA has stated: ``The practice of requiring substance use disorder
information to be any more private than information regarding other
chronic illnesses, such as cancer or heart disease, may in itself be
stigmatizing. Patients with substance use disorders seeking treatment
for any condition have a right to healthcare providers who are fully
equipped with the information needed to provide the highest quality
care available.''
When a person violates part 2, it is referred to the Justice
Department,
[[Page H5329]]
and there is only a $50 penalty. There have been zero cases--let me
repeat that--there have been zero cases in which part 2 was enforced or
any action taken by the Department of Justice or SAMHSA.
The penalties for noncompliance underneath HIPAA are based on the
level of negligence and can range from $100 to $50,000 per violation,
with a maximum of $1.5 million per year.
There have been 173,472 HIPAA violations since 2003, with 97 percent
of those complaints resolved.
Patients, doctors, hospitals, and a broad spectrum of stakeholders
agree we need to end this outdated Federal Government mandate helping
prevent the private sector's innovation.
Mr. Speaker, I encourage my colleagues to support the Overdose
Prevention and Patient Safety Act.
Mr. PALLONE. Mr. Speaker, I yield 3 minutes to the gentleman from
Oregon (Mr. Blumenauer).
Mr. BLUMENAUER. Mr. Speaker, I appreciate Mr. Pallone's courtesy in
permitting me to speak on this bill. I respect his efforts, and I
respect a number of his concerns. But I do think that the work that we
have done with Mr. Mullin, with the committee, and I appreciate the
subcommittee's extra efforts to work through these elements, listen to
people's objections, and to do it right.
There has been no argument that this provision has cost lives. The
failure in emergency rooms, other circumstances, for people to not be
able to get the full picture of a patient's condition ends up sometimes
with tragic consequences. We have yet to hear any reason why we
shouldn't coordinate.
Now, I appreciate concerns about patient privacy, but as Dr. Burgess
and my friend from Oklahoma point out, we are strengthening provisions
under this bill for disclosure. People don't want to stigmatize those
with substance abuse, we agree. But having a separate system that
people have to go through just for substance abuse implies a stigma.
People will think there is something wrong with these people. You don't
do this for AIDS anymore. This harmonizes with all the other HIPAA
provisions.
Candidly, forcing people to go through yet another step probably
raises questions about the validity of disclosure, raising questions in
the minds of those who go through that.
Mr. Speaker, we have made, I think, tremendous progress dealing with
stigma, dealing with patient protection, what we have done for mental
health, which has devastating consequences in some cases if people's
records were revealed. Think what has happened with HIV/AIDS. There was
a time when that would end up with people not just having a stigma but
at risk of losing their jobs, being ostracized.
These are the same provisions in this bill that are there for HIV/
AIDS or mental health, for everything under HIPAA.
I really do think that we take a step back, understanding that having
separate authorizations complicates the coordination and integration of
treatment. Oftentimes, behavioral health information doesn't arrive in
an orderly fashion. It is another step of complication that could have
tragic consequences.
In fact, the subcommittee's record demonstrates that. There have been
examples where people have died because the medical providers did not
have the full picture of the patient. This legislation will fix it.
Mr. BURGESS. Mr. Speaker, I yield 5 minutes to the gentleman from
Oregon (Mr. Walden), the chairman of the full committee.
Mr. WALDEN. Mr. Speaker, I want to thank Dr. Burgess, the chairman of
the Subcommittee on Health, for his fine leadership on this issue,
along with our colleagues, Mr. Mullin and my friend from Oregon and
colleague, Mr. Blumenauer, who put a lot of work into this. I commend
my colleague from Oregon for his strong statement in support of this
legislation.
Combating the opioid epidemic has been a top priority of all of us in
this Congress and especially on the Energy and Commerce Committee,
which I chair.
We have committed the last year and a half to examining the ways we
can respond to save lives, to help people in our communities, and to
end this deadly, deadly epidemic.
During that time, I have heard a lot of stories, both at the hearings
here in the Nation's Capital and back home in Oregon, where I have held
multiple roundtables and meetings in the communities about what we need
to do to help the outcome of patients; our neighbors, our friends, in
some cases family members, who are dealing with these addictions.
An extraordinary array of people, including patients, parents of
those suffering with addiction, the Oregon Hospital Association, Oregon
Governor Kate Brown, physicians, and substance use disorder treatment
providers, have all told me and our committee that existing Federal
confidentiality regulations and statute known as 42 CFR part 2, or
simply part 2, are working against--working against--patients and
making it harder to effectively treat addiction. There is hardly anyone
in the healthcare sector that we have not heard from on this issue.
One story that really comes to mind is that of Brandon McKee.
Brandon's brother, Dustin, testified before our Health Subcommittee
when we reviewed a near identical version of this legislation back in
May.
Tragically, Brandon had died of an opioid overdose at just 36 years
of age. He left behind three young children.
Speaking about his passing, his brother Dustin told the subcommittee:
``Brandon's death was preventable. However, in part because of the
antiquated provisions contained within 42 CFR part 2, the medical
professionals that prescribed him opiate-based pain medications were
not able to identify him as a high-risk individual.''
You see, Brandon was prescribed opioids after back surgery on two
separate occasions despite his history of substance use disorder.
Within a few months of his second surgery, Brandon fatally overdosed on
heroin. That is why this bill is so important.
Health records for substance use disorder are the only--only--records
that are siloed in this way, preventing physicians from seeing the
complete picture of a patient they are treating. The doctors don't
know.
All other protected health information for every other disease falls
under HIPAA. The Overdose Prevention and Patient Safety Act will help
align Federal privacy standards for substance use disorder treatment
information more closely with HIPAA so that our doctors and our
addiction specialists can provide the highest and safest level of
treatment.
In short, this bill will improve coordination of care for patients
suffering from substance use disorder and save lives by helping to
prevent overdoses and dangerous drug interactions.
Now, I fully respect and understand the privacy concerns that some
still have, and the sensitivities about the idea of making changes to a
statute that has been in place since the 1970s, long before HIPAA. That
is why Representatives Mullin and Blumenauer worked in a bipartisan
fashion to include strong unlawful disclosure penalties, discrimination
protections, and breach notification requirements in this bill.
Doing so, H.R. 6082 will actually improve the ability to penalize
those who illegally disclose a patient's information. This isn't about
using this information for any other purpose than treating that patient
safely.
To be clear, there is no legal way for a patient's substance use
disorder treatment information to be used against them under this bill.
This bill, instead, expands protections for individuals seeking
addiction treatment above and beyond existing law, and it will help us
turn the tide on the opioid scourge.
I want to thank Mr. Mullin and Mr. Blumenauer once again for their
work, and the other Members on the committee. This bipartisan bill will
save lives. It is critically importantly to our efforts to combat the
opioid crisis, and I urge my colleagues to support H.R. 6082.
Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, proponents of this legislation argue that taking away
patients' privacy rights related to substance use disorder treatment
records is okay because we would be applying the HIPAA standard that
applies to other sensitive health conditions like HIV, but I strongly
disagree.
[[Page H5330]]
Individuals with substance use disorder face risk because of their
medical conditions that those with other medical conditions do not.
According to SAMHSA, those negative consequences include loss of
employment, loss of housing, loss of child custody, discrimination by
medical professionals and insurers, arrests, prosecution, and
incarceration.
Unlike other medical conditions, including HIV, you can be
incarcerated, legally fired, and denied visitation with your children
due to your substance use disorder.
So let me paint this picture with a few examples.
A 20-year-old pregnant woman in Wisconsin voluntarily went to a
hospital to seek treatment for addiction to the opiate OxyContin.
Rather than providing treatment, the hospital called State authorities
to report this woman. She was taken into custody and held for several
weeks before a judge ordered her released.
Another example provided to the committee from a provider in Maryland
explained:
Some time ago, we had a young lady in our methadone
maintenance program who committed suicide. She had turned her
life around. She was in college, working full time, owned her
own car, was purchasing a house, and was no longer using
illicit substances. She had to complete probation for her
crimes that she had committed while she was actively using
these drugs.
Her mother did not know she was in methadone treatment. She
did not want her mother to know because her mother did not
agree with methadone, and the judge found out she was in the
methadone maintenance program and disclosed it in a court
hearing with her mother present.
The judge and her mother insisted that she ``get off that
stuff,'' and she complied only because of the pressure from
both to do so.
She began abusing illicit substances and participating in
illegal activity to obtain those substances. The guilt and
shame of returning to what she described as a life of hell
led her to write a suicide note and end her life.
{time} 1315
Experiences like this, in addition to stories of individuals with
substance use disorder who have lost jobs, housing, and child custody
because of their substance use disorder, are reasons that some
individuals with substance use disorder fear coming forward to enter
treatment due to the negative consequences that result. It is why more
than 100 groups, including AIDS United, joined the campaign to protect
patient privacy rights. They have joined together to fight to protect
the heightened privacy protections that exist under existing law.
Further, unlike the proponents of this legislation contend, the
existing law is not an anomaly. States like Florida have laws requiring
written patient consent for the sharing of a patient's substance use
disorder and mental health treatment records, while others like New
York, Kentucky, and Texas have such requirements for the sharing of HIV
records. Other States have such requirements for reproductive health
treatment records.
Further, the existing law is consistent with the confidentiality
protections applied to substance use disorder treatment records. In
fact, the law governing the confidentiality of VA medical records, 38
U.S.C. 7332, is consistent with and broader than part 2. Unlike that
law, the VA cannot share a patient's substance use disorder, HIV, or
sickle cell anemia treatment records with another provider without
written patient consent.
So, Mr. Speaker, I want to stress that I do believe that we can learn
an important lesson from our response to HIV, particularly during the
height of the AIDS epidemic. A critical part of this Nation's response
to the AIDS epidemic was increasing the privacy protections applied to
HIV medical records. Such action was taken because people were afraid
to enter treatment for HIV/AIDS because of the negative consequences
that could result.
In the midst of the opioid epidemic, this bill would result in doing
just the opposite: lowering the privacy protections applied to
substance use disorder medical records despite the fact that, like
during the AIDS epidemic, some individuals with substance use disorder
remain afraid to enter treatment because of the negative consequences
that result. And in many cases, they only do so out of the part 2
assurances that they can control to whom and for what purposes their
treatment record is shared.
The increased stigma, discrimination, and criminalization faced by
people with substance use disorder support the maintenance of the
heightened privacy protections under existing law, in my opinion. And
for some individuals, it is these privacy protections that make them
feel safe to enter and remain in treatment for their substance use
disorder. I am afraid that by passing this bill we could be creating a
barrier that will keep people from getting the treatment they need, and
that is a risk I am simply not willing to take.
Mr. Speaker, I reserve the balance of my time.
Mr. BURGESS. Mr. Speaker, I yield myself 2 minutes for the purpose of
response before I yield to Dr. Bucshon.
Mr. Speaker, the tragic story that was just related to us really only
reinforces the need to change the statute behind 42 CFR part 2. There
are some important facts missing from the description of the situation
that occurred.
It appears evident that at least one or both of the parties involved,
the judge, and/or the methadone maintenance program, violated existing
regulations under both part 2 and HIPAA.
Under part 2, patient records may only be disclosed without patient
consent if the disclosure is authorized by an appropriate order of a
court of competent jurisdiction. There must be a showing of good cause
in which the court must weigh the public interest and need for
disclosure against the injury to the patient, the physician-patient
relationship, and treatment services. Further, the court must impose
appropriate safeguards against unauthorized disclosure.
It is not clear from the description provided in the letter how the
judge found out about the patient's participation in a methadone
maintenance program. If the information to the judge was provided
without an appropriate court order, then the methadone maintenance
program likely violated the requirements under part 2 to safeguard the
patient's records from such disclosure. If the information was provided
as a result of a court order, then it is possible that the judge
violated his or her ethical obligations to appropriately weigh the need
for the information and safeguard the information once received.
Under HIPAA, there is still an obligation for the parties seeking
information to confirm that reasonable efforts have been made to ensure
that the individual has been given notice of the request for personal
health information and the opportunity to object or that reasonable
efforts have been made to secure a qualified protective order.
Compliance with either of these requirements appears to have been
lacking in the situation described in the letter.
All of this suggests that part 2 currently is insufficient to protect
patients in these situations. The legislation before us today does not
decrease the protections against the use of the records in criminal
proceedings that already exist under part 2, but HIPAA makes the
protections stronger.
I yield 3 minutes to the gentleman from Indiana (Mr. Bucshon), a
valuable member of our committee and our subcommittee that has heard
the testimony on this legislation.
Mr. BUCSHON. Mr. Speaker, I rise today to speak in strong support of
H.R. 6082, the Overdose Prevention and Patient Safety Act. This
legislation will improve the ability of medical professionals to
properly care for patients by allowing physicians access to a
patient's full medical record, including information about substance
use disorder treatment, while ensuring robust privacy protections.
As a physician, I know that patients don't always notify their
doctors of all the medications they are taking, and not having a
complete medical record or knowing a patient's background can result in
potentially life-threatening complications related to medical
treatment. I have seen this in my own practice, and my wife sees this
almost daily in her anesthesia practice.
This is commonsense legislation which will ensure patients receive
appropriate healthcare, while also ensuring the medical information
remains private. Mr. Speaker, I urge my colleagues to support H.R.
6082.
Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
[[Page H5331]]
Mr. Speaker, some of the proponents of this bill also mentioned the
opiate use disorder situations in emergency rooms as a justification
for the legislation, but I just want to say, Mr. Speaker, I think it is
important to note that the existing law includes an exception to the
patient consent requirement. A provider can access a patient's
substance use disorder treatment records in the case of an emergency as
determined by the provider without patient consent.
Additionally, nothing in the existing law prevents any provider from
asking their patient about their substance use disorder history before
prescribing any opioid, especially in the midst of the opioid epidemic.
Every provider should ask patients about their opioid use disorder
history, and, therefore, under the existing law and every other privacy
law, the doctor can learn of a patient's opiate use disorder history by
simply asking the patient that.
That remains, in my opinion, the optimum way of learning a patient's
medical history, because currently our electronic health records aren't
interoperable in many cases. Those underlying interoperability issues
that prevent information sharing, including the part 2 information in
cases where a patient has agreed to share their information with
providers, aren't going to be solved by this bill.
Mr. Speaker, I reserve the balance of my time.
Mr. BURGESS. Mr. Speaker, I yield 3 minutes to the gentleman from
Illinois (Mr. Shimkus), a valuable member of the Energy and Commerce
Committee.
(Mr. SHIMKUS asked and was given permission to revise and extend his
remarks.)
Mr. SHIMKUS. Mr. Speaker, it is good to be on the floor with my good
friend and colleague, the ranking member, Congressman Pallone. I know
his heart is solid and I know he believes that we are challenging some
privacy concerns, and I take that in the spirit intended.
As a Republican, I was an early supporter of one of our former
colleague's--Sue Myrick's--Mental Health Parity Act. And the whole
intent of that, for many of us, was to say mental health illness is an
illness and should be accepted as an illness. But what we have done
under the Federal code is to separate it. So I think the intent of what
we are trying to do is not separate it and make it part of the health
records.
We have heard the debate on both sides, but that is the basic premise
from which I come. And we have heard the testimony of people for whom
the information was not shared with the regular doctor versus the
mental health, and then prescriptions occurring and then catastrophic
events.
The intent of this legislation is to help patients and to help
providers better take care of their patients. This is not about taking
away privacy but taking care of people. It is about making sure people
have the appropriate level of privacy for the services they are
seeking.
We don't create extra privacy barriers so that people with heart
disease, HIV, or diabetes can keep their doctors in the dark and
withhold critical information relevant to the insurer benefits that
they are using. This goes back to, as we have heard today, a 1970-era
mandate.
Gary Mendell, the founder of Shatterproof, lost his son Brian, who
was recovering from substance use disorder, after he tragically took
his own life. Gary said the following about aligning part 2 with HIPAA:
The solution is not to keep this information out of
electronic health records and not available. The solution is
to end the stigma and to bring this disease and mental
illness into the healthcare system, just like diabetes,
cancer, or any other disease.
And I couldn't agree more with Gary.
He also said:
If there's an issue related to unintended consequences,
let's fix that.
I think in this piece of legislation, Congressman Mullin and
Congressman Blumenauer intended to do that.
Gary also said:
Let's not keep this out of the healthcare system, unlike
diabetes, heart disease, and cancer, because then we just
perpetuate the situation that is causing it in the first
place.
I will continue. Individuals with opioid use disorder die, on
average, a decade sooner than other Americans. This is largely because
of the strikingly high incidence of poorly managed, co-occurring
chronic diseases, including HIV/AIDS, cardiac conditions, lung disease,
and cirrhosis.
Whatever we as a nation are doing to coordinate care for this highly
vulnerable population is failing by any reasonable measure.
The SPEAKER pro tempore. The time of the gentleman has expired.
Mr. BURGESS. Mr. Speaker, I yield an additional 30 seconds to the
gentleman from Illinois.
Mr. SHIMKUS. Mr. Speaker, an extraordinary array of organizations,
hospitals, physicians, patient advocates, and substance use treatment
providers have approached this committee to clearly state that existing
Federal addiction privacy law is actively interfering with case
management and care coordination efforts. Arguing against this
legislation preserved a fatal and deadly status quo.
I support this piece of legislation, and I thank my colleague for the
time.
Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I mentioned earlier the various groups that are opposed
to this legislation because of the privacy concerns, and I actually
would like to read or go through some sections from this letter that
was sent to Chairman Walden and me from over 100 groups, including the
New Jersey Association of Mental Health and Addiction Agencies.
And they say, Mr. Speaker:
Dear Chairman Walden and Ranking Member Pallone:
We, the undersigned national, State, and local
organizations strongly support maintaining the core
protections of the Federal substance use disorder patient
confidentiality law and its regulations, referred to
collectively as part 2.
And they say:
We remain concerned that using a weaker HIPAA privacy rule
standard of allowing disclosure of substance use disorder
information without patient consent or other purposes will
contribute to the existing level of discrimination and harm
to people living with substance use disorders. This will only
result in more people who need substance use disorder
treatment being discouraged and afraid to seek the healthcare
they need during the Nation's worst opioid crisis.
We strongly support maintaining part 2's current core
protections for substance use disorder information instead of
those weaker HIPAA privacy standards for the following
reasons.
And there are five.
One, the heightened privacy protections in part 2 are as
critical today as they were when they were enacted more than
40 years ago and must be preserved.
Two, in the midst of the worst opioid epidemic in our
Nation's history, we must do everything possible to increase,
not decrease, the number of people who seek treatment.
{time} 1330
Three, substance use disorder is unique among medical
conditions because of its criminal and civil consequences and
the rampant discrimination people face.
Four, with so much at stake, patients in substance use
disorder treatment should retain the right to consent when
and to whom their records are disclosed, as currently found
in part 2.
Five, effective integration of substance use disorder
treatment with the rest of the healthcare system is
critically important, and information exchange in accordance
with confidentiality law and current technology is now
possible. To facilitate that process, SAMHSA recently amended
the part 2 regulations to further promote the integration of
confidential substance use disorder information into general
health records.
They finally conclude, Mr. Speaker, by saying:
We respectfully request that the House Energy and Commerce
Committee maintain the current confidentiality protections of
part 2 to support individuals entering and staying in
substance use disorder treatment and recovery services.
Mr. Speaker, I include in the Record this letter from these patients.
Campaign To Protect Patient
Privacy Rights,
June 18, 2018.
Re Opposition to H.R. 6082--``Overdose Prevention and Patient
Safety Act''.
Representative Greg Walden,
Chairman of the U.S. House of Representatives Energy and
Commerce Committee, Washington, DC.
Representative Frank Pallone, Jr.,
Ranking Member of the U.S. House of Representatives Energy
and Commerce Committee, Washington, DC.
Dear Chairman Walden and Ranking Member Pallone: We, the
undersigned national, state, and local organizations strongly
support maintaining the core protections of the federal
substance use disorder patient confidentiality law (``42
U.S.C. 290dd-2'') and its regulations ``42 CFR Part 2,''
(referred to
[[Page H5332]]
collectively as ``Part 2'') to effectively protect the
confidentiality of patients' records. The Substance Abuse and
Mental Health Service Administration (``SAMHSA'') recently
amended Part 2's patient privacy regulations in 2017 and
2018, which accomplishes the bill's proposed objective of
providing coordinated care between substance use disorder
(``SUD'') and other health care information.
We remain concerned that using a weaker HIPAA Privacy Rule
standard of allowing disclosures of SUD information without
patient consent for treatment, payment, health care
operations, or other purposes other than those currently
allowed by Part 2--will contribute to the existing level of
discrimination and harm to people living with substance use
disorders. This will only result in more people who need
substance use disorder treatment, being discouraged and
afraid to seek the health care they need during the nation's
worst opioid crisis.
We strongly support maintaining Part 2's current core
protections for SUD information, instead of those of a weaker
HIPAA Privacy standard as described in H.R. 6082 for the
following reasons:
1. The heightened privacy protections in Part 2 are as
critical today as they were when they were they were enacted
more than 40 years ago, and must be preserved.
2. In the midst of the worst opioid epidemic in our
nation's history, we must do everything possible to
increase--not decrease--the number of people who seek
treatment.
3. SUD is unique among medical conditions because of its
criminal and civil consequences and the rampant
discrimination people face.
4. With so much at stake, patients in SUD treatment should
retain the right to consent when and to whom their records
are disclosed, as currently found in Part 2.
5. Effective integration of SUD treatment with the rest of
the health care system is critically important, and
information exchange in accordance with confidentiality law
and current technology is now possible. To facilitate that
process, SAMHSA recently amended the Part 2 regulations to
further promote the integration of confidential SUD
information into general health records.
We respectfully request that the House Energy and Commerce
Committee maintain the current confidentiality protections of
Part 2 to support individuals entering and staying in SUD
treatment and recovery services.
Sincerely,
Campaign to Protect Privacy Rights: A New PATH; Addiction
Haven; Addictions Resource Center, Waukesha, WI (ARC, Inc.);
Advocates for Recovery Colorado; AIDS United; Alano Club of
Portland; Alcohol & Addictions Resource Center, South
Bend, IN; American Association for the Treatment of Opioid
Dependence (AATOD); American Group Psychotherapy
Association; Apricity; Arthur Schut Consulting LLC;
Association of Persons Affected by Addiction; Atlantic
Prevention Resources; California Consortium of Addiction
Programs & Professionals (CCAPP); Capital Area Project
Vox--Lansing (MI)'s Voice of Recovery; Center for Recovery
and Wellness Resources; CFC Loud N Clear Foundation;
Chicago Recovering Communities Coalition; Colorado
Behavioral Healthcare Council; Communities for Recovery.
Community Catalyst; Connecticut Community for Addiction
Recovery (CCAR); Council on Addiction Recovery Services
(CAReS)-Orlean, NY; DarJune Recovery Support Services & Cafe;
Davis Direction Foundation--The Zone; Daystar Center; Delphi
Behavioral Health Group--Maryland House Detox; Detroit
Recovery Project; The DOOR--DeKalb Open Opportunity for
Recovery; Drug and Alcohol Service Providers Organization of
Pennsylvania; El Paso Alliance; Faces & Voices of Recovery;
Faces and Voices of Recovery (FAVOR)--Grand Strand-SC; Faces
and Voices of Recovery (FAVOR)--Greenville, SC; Faces and
Voices of Recovery (FAVOR)--Low Country: Charleston, SC;
Faces and Voices of Recovery (FAVOR)--Mississippi Recovery
Advocacy Project; Faces and Voices of Recovery (FAVOR)--Pee
Dee, SC; Faces and Voices of Recovery (FAVOR)--Tri-County:
Rock Hill, SC; Facing Addiction; Fellowship Foundation
Recovery Community Organization.
Foundation for Recovery; Friends of Recovery--New York;
Georgia Council on Substance Abuse; Greater Macomb Project
Vox; Harm Reduction Coalition; Home of New Vision; HOPE for
New Hampshire Recovery; Jackson Area Recovery Community--
Jackson, MI; Latah Recovery Center; Legal Action Center;
Lifehouse Recovery Connection; Long Island Recovery
Association (LIRA); Lotus Peer Recovery; Maine Alliance for
Addiction Recovery; Massachusetts Organization for Addiction
Recovery; Message Carriers of Pennsylvania; Mid-Michigan
Recovery Services (NCADD Mid-Michigan Affiliate); Minnesota
Recovery Connection; Missouri Recovery Network.
National Advocates for Pregnant Women; National Alliance
for Medication Assisted Recovery (NAMA Recovery); National
Association for Children of Addiction (NACoA); National
Association of County Behavioral Health and Developmental
Disability Directors (NACBHDD); National Association for
Rural Mental Health (NARMH); National Center on Domestic
Violence, Trauma & Mental Health; National Council on
Alcoholism and Drug Dependence, Inc. (NCADD); National
Council on Alcoholism and Drug Dependence--Central
Mississippi Area, Inc.; National Council on Alcoholism and
Drug Dependence--Maryland; National Council on Alcoholism
and Drug Dependence--Phoenix; National Council on
Alcoholism and Drug Dependence--San Fernando Valley;
Navigating Recovery of the Lakes Region; New Jersey
Association of Mental Health and Addiction Agencies;
Northern Ohio Recovery Association; Oklahoma Citizen
Advocates for Recovery and Transformation Association
(OCARTA); Overcoming Addiction Radio, Inc.; Parent/
Professional Advocacy League; Peer Coach Academy Colorado;
Pennsylvania Recovery Organizations--Alliance (PRO-A).
People Advocating Recovery (PAR); Pennsylvania Recovery
Organization--Achieving Community Together (PRO-ACT);
Portland Recovery Community Center; Public Justice Center;
REAL--Michigan (Recovery, Education, Advocacy & Leadership);
Recover Project/Western MA Training; Recover Wyoming;
RecoveryATX; Recovery Alliance of Austin; Recovery Allies of
West Michigan; Recovery Cafe; Recovery Communities of North
Carolina; Recovery Community of Durham; Recovery Consultants
of Atlanta; Recovery Epicenter Foundation, Inc.; Recovery
Force of Atlantic County; Recovery is Happening; Recovery
Resource Council; Recovery Organization of Support
Specialist.
Revive Recovery, Inc.; Rhode Island Cares About Recovery
(RICARES); Rochester Community Recovery Center; ROCovery
Fitness; Safe Harbor Recovery Center; SMART Recovery (Self-
Management and Recovery Training); S.O.S. Recovery Community
Organization; SpiritWorks Foundation; Springs Recovery
Connection; Tennessee Association of Alcohol, Drug & other
Addiction Services (TAADAS); The Bridge Foundation; The
Courage Center; The McShin Foundation; The Ohana Center for
Recovery; The Serenity House of Flint; The Phoenix; The RASE
Project; The Recovery Channel; Tia Hart Community Recovery
Program.
Together Our Recovery Center Heals (T.O.R.C.H.), Inc.;
Treatment Trends, Inc.; Trilogy Recovery Community; U MARC
(United Mental Health and Addictions Recovery Coalition);
Utah Support Advocates for Recovery Awareness (USARA);
Vermont Recovery Network; Voices of Hope for Cecil County,
MD; Voices of Hope Lexington; Voices of Recovery San Mateo
County, CA; WAI-IAM, Inc. and RISE Recovery Community;
Wisconsin Voices for Recovery; Young People in Recovery.
Mr. PALLONE. Mr. Speaker, I reserve the balance of my time.
Mr. BURGESS. Mr. Speaker, I yield myself 3 minutes.
Mr. Speaker, I would like to point out that there are over 100 groups
in support of the Partnership to Amend 42 CFR part 2. A letter from
that partnership says, in part:
We are pleased that the bill aligns part 2 with HIPAA's
consent requirements for the purposes of treatment, payment
and operations, which will allow for the appropriate sharing
of substance use disorder records, among covered entities, to
ensure persons with opioid use disorder and other substance
use disorders receive the integrated care that they need.
Additionally, as we do not want patients with substance use
disorders to be made vulnerable as a result of seeking
treatment for addiction, this legislation strengthens
protections and limits the number of institutions that have
access to their records.
I am not going to read all of the names on the list, but some of the
notable ones are the National Alliance on Mental Illness, Mental Health
America, Hazelden Betty Ford Foundation, National Governors
Association, Healthcare Leadership Council, American Hospital
Association, American Society of Addiction Medicine, Centerstone, New
Jersey Hospitals, and National Association of Addiction Treatment
Providers.
Mr. Speaker, I include in the Record the entire list of all of the
groups in favor of the Partnership to Amend 42 CFR.
Partnership To Amend 42 CFR Part 2--A Coalition of Over 40 Health Care
Stakeholders Committed To Aligning 42 CFR Part 2 (Part 2) With HIPAA To
Allow Appropriate Access to Patient Information That Is Essential for
Providing Whole-Person Care
June 15, 2018.
Hon. Markwayne Mullin,
House of Representatives,
Washington, DC.
Hon. Earl Blumenauer,
House of Representatives,
Washington, DC.
Dear Representatives Mullin and Blumenauer: The undersigned
members of the Partnership to Amend 42 CFR Part 2
(Partnership) and additional stakeholder organizations
applaud your leadership on the issue of substance use
disorder privacy records. We strongly support the Overdose
Prevention and Patient Safety (OPPS) Act, H.R. 6082, which
will align 42 CFR Part 2 (Part 2) with the Health Insurance
Portability and Accountability Act (HIPAA) for the purposes
of health care treatment, payment, and operations (TPO). The
Partnership is pleased that the OPPS Act was voted out of the
Committee on Energy and Commerce with a bipartisan vote.
[[Page H5333]]
The Partnership is a coalition of more than 40
organizations representing stakeholders across the health
care spectrum committed to aligning Part 2 with HIPAA to
allow appropriate access to patient information that is
essential for providing whole-person care.
We are pleased that the bill aligns Part 2 with HIPAA's
consent requirements for the purposes of TPO, which will
allow for the appropriate sharing of substance use disorder
records, among covered entities, to ensure persons with
opioid use disorder and other substance use disorders receive
the integrated care they need. Additionally, as we do not
want patients with substance use disorders to be made
vulnerable as a result of seeking treatment for addiction,
this legislation strengthens protections and limits the
number of institutions that have access to patient records.
Thank you both for your leadership on this issue and we
look forward to working with you on helping to address the
opioid crisis by passing this important bipartisan
legislation on the floor of the U.S. House of
Representatives.
Sincerely,
Partnership to Amend 42 CFR Part 2 Members
Academy of Managed Care Pharmacy; American Association on
Health and Disability; American Health Information Management
Association; American Hospital Association; American
Psychiatric Association; American Society of Addiction
Medicine; American Society of Anesthesiologists; America's
Essential Hospitals; America's Health Insurance Plans; AMGA;
Association for Ambulatory Behavioral Healthcare; Association
for Behavioral Health and Wellness; Association for Community
Affiliated Plans; BlueCross BlueShield Association; Catholic
Health Association of the U.S.; Centerstone; Confidentiality
Coalition; Employee Assistance Professionals Association;
Global Alliance for Behavioral Health and Social Justice;
Hazelden Betty Ford Foundation.
Health IT Now; Healthcare Leadership Council; The Joint
Commission; InfoMC; Medicaid Health Plans of America; Mental
Health America; National Alliance on Mental Illness; National
Association for Behavioral Healthcare; National Association
of ACOs; National Association of Counties (NACo); National
Association of State Mental Health Program Directors
(NASMHPD); Netsmart; OCHIN; Otsuka; Pharmaceutical Care
Management Association; Premier Healthcare Alliance.
Additional Stakeholder Organizations
ACO Health Partners; Aetna; AMITA Health; Anthem, Inc.;
Ascension Health; Avera Health; Banner Health; Baptist
Healthcare System; Beacon Health Options; Bon Secours Health
System, Inc.; CareSource; Catholic Health Initiatives;
Centene Corporation; Change Healthcare; Cigna; College of
Healthcare Information Management Executives (CHIME).
Excellus BlueCross BlueShield; Franciscan Sisters of
Christian Charity Sponsored Ministries, Inc.; Greater New
York Hospital Association; Henry Ford Health System; Howe
Home Designers; Johns Hopkins Medicine; Kern Health
Systems; Leidos; Lycoming County; Magellan Health;
Marshfield Clinic Health System; Mental Health America of
Indiana; Mosaic Life Care; NAMI; NAMI DC; NAMI Delaware.
NAMI Greene County Tennessee; NAMI Helena; NAMI of Howard
County, MD; NAMI Jefferson County, Washington; NAMI Kaufman
County; NAMI Kershaw County; NAMI Lewistown; NAMI Lexington;
NAMI of the Pee Dee (South Carolina); NAMI Piedmont Tri-
County; NAMI Sarasota County; NAMI South Suburbs of Chicago;
NAMI Sussex, Inc.; NAMI Temple Area; NAMI Utah; NAMI Valley
of the Sun.
National Alliance on Mental Illness (NAMI) Texas; National
Association of Addiction Treatment Providers; New Directions
Behavioral Health; OPEN MINDS; Optum; PerformCare; Providence
St. Joseph Health; SCAN Health Plan; SSM Health; Texas Health
Resources; The Center for Health Affairs/Northeast Ohio
Hospital Opioid Consortium; The MetroHealth System; Trinity
Health; University of Tennessee Medical Center; Valley Health
System; Vizient; Wayne Meriwether.
Mr. BURGESS. Mr. Speaker, I reserve the balance of my time.
Mr. PALLONE. Mr. Speaker, I yield myself the balance of my time.
Mr. Speaker, I just want to say in conclusion today, that amidst the
worst opioid epidemic our country has ever faced, I think it is really
important that we not take any action that could result in any
individual with an opiate use disorder not seeking or remaining in
treatment for this life-threatening condition.
I understand the opinions on both sides, but I do think that if we
don't protect the existing privacy and keep the current law with regard
to privacy that we will see many individuals not seeking treatment or
remaining in treatment. That is why I strongly oppose this bill, and I
urge my colleagues to vote ``no.''
Mr. Speaker, I yield back the balance of my time.
Mr. BURGESS. Mr. Speaker, I yield myself the balance of my time.
Mr. Speaker, by continuing to segregate substance use disorder
records means that we are willing to allow some patients to receive
care that is potentially lower quality at a higher cost.
Treating patient substance use disorder in isolation from their
medical and mental health conditions--which predominated care in the
1970s--is not the standard for good practice today. There is now
overwhelming evidence that patients' substance use disorders cannot be
treated in isolation from other healthcare conditions. In the 1970s
when part 2 was written, this was not widely accepted, and treatment
for addiction was largely separate from treatment for other illnesses.
Mr. Speaker, further, I would say that the problem here is we need to
treat addiction just like any other medical illness and improve our
outreach to patients who meet the criteria for treatment. Maintaining a
decades old, ineffective confidentiality law simply is not going to do
that.
I urge my colleagues to support the bill. It is a good bill supported
by Mr. Mullin and Mr. Blumenauer.
Mr. Speaker, I yield back the balance of my time.
The SPEAKER pro tempore (Mr. Bost). All time for debate has expired.
Pursuant to House Resolution 949, the previous question is ordered on
the bill, as amended.
The question is on the engrossment and third reading of the bill.
The bill was ordered to be engrossed and read a third time, and was
read the third time.
Motion to Recommit
Mr. PALLONE. Mr. Speaker, I have a motion to recommit at the desk.
The SPEAKER pro tempore. Is the gentleman opposed to the bill?
Mr. PALLONE. I am opposed to H.R. 6082.
Mr. BURGESS. Mr. Speaker, I reserve a point of order against the
motion.
The SPEAKER pro tempore. A point of order is reserved.
The Clerk will report the motion to recommit.
The Clerk read as follows:
Mr. Pallone moves to recommit the bill H.R. 6082 to the
Committee on Energy and Commerce with instructions to report
the same back to the House forthwith with the following
amendment:
Strike page 1, line 4, through page 8, line 20.
Strike page 11, line 8, through page 12, line 9.
Page 8, line 21, through page 11, line 7, promote
subsection (k) to become a section which reads as follows:
SEC. 2. DEVELOPMENT AND DISSEMINATION OF MODEL TRAINING
PROGRAMS FOR SUBSTANCE USE DISORDER PATIENT
RECORDS.
(a) Initial Programs and Materials.--Not later than 1 year
after the date of the enactment of this Act, the Secretary of
Health and Human Services (referred to in this section as the
``Secretary''), in consultation with appropriate experts,
shall identify the following model programs and materials (or
if no such programs or materials exist, recognize private or
public entities to develop and disseminate such programs and
materials):
(1) Model programs and materials for training health care
providers (including physicians, emergency medical personnel,
psychiatrists, psychologists, counselors, therapists, nurse
practitioners, physician assistants, behavioral health
facilities and clinics, care managers, and hospitals,
including individuals such as general counsels or regulatory
compliance staff who are responsible for establishing
provider privacy policies) concerning the permitted uses and
disclosures, consistent with the standards and regulations
governing the privacy and security of substance use disorder
patient records promulgated by the Secretary under section
543 of the Public Health Service Act (42 U.S.C. 290dd-2) for
the confidentiality of patient records.
(2) Model programs and materials for training patients and
their families regarding their rights to protect and obtain
information under the standards and regulations described in
paragraph (1).
(b) Requirements.--The model programs and materials
described in paragraphs (1) and (2) of subsection (a) shall
address circumstances under which disclosure of substance use
disorder patient records is needed to--
(1) facilitate communication between substance use disorder
treatment providers and other health care providers to
promote and provide the best possible integrated care;
(2) avoid inappropriate prescribing that can lead to
dangerous drug interactions, overdose, or relapse; and
(3) notify and involve families and caregivers when
individuals experience an overdose.
(c) Periodic Updates.--The Secretary shall--
[[Page H5334]]
(1) periodically review and update the model program and
materials identified or developed under subsection (a); and
(2) disseminate such updated programs and materials to the
individuals described in subsection (a)(1).
(d) Input of Certain Entities.--In identifying, reviewing,
or updating the model programs and materials under this
section, the Secretary shall solicit the input of relevant
stakeholders.
At the end, insert the following new section:
SEC. 3. REPORT ON PATIENT EXPERIENCE WITH PART 2.
(a) Report.--The Secretary of Health and Human Services (in
this section referred to as the ``Secretary'') shall conduct
or support a study that examines information sharing
behaviors of individuals who obtain substance use disorder
treatment through a Part 2 program.
(b) Topics.--The study pursuant to subsection (a) shall
examine the extent to which patients at Part 2 programs agree
to share their information, including the following:
(1) Patient understanding regarding their rights to protect
and obtain information under Part 2.
(2) Concerns or feelings patients have about sharing their
Part 2 treatment records with other health care providers and
organizations.
(3) Whether or not patients agree to share their Part 2
medical records.
(4) The extent of providers with which patients agree to
share their Part 2 treatment records.
(5) If patients have shared their Part 2 treatment
information--
(A) at what point in the treatment relationship with the
Part 2 program did the patients choose to do so; and
(B) what prompted the patients to share the information.
(6) What considerations were taken into account by the
patient when deciding whether or not and with whom to share
their Part 2 treatment information.
(7) How did having the choice to decide to what extent and
with whom to share Part 2 treatment records affect patients'
decision to uptake or remain in treatment.
(8) Would not having a choice to decide the extent to which
to share their treatment records from Part 2 programs affect
a patient's decision to participate or stay in treatment.
(c) Scope.--The study under subsection (a) shall--
(1) include a nationally representative sample of
individuals obtaining treatment at Part 2 programs; and
(2) consider patients of Part 2 programs being treated for
various substance use disorders, including opioid use
disorder and alcohol use disorder.
(d) Report.--Not later than 2 years after the date of
enactment of this Act, the Secretary shall submit a report to
the Congress on the results of the study under subsection
(a).
(e) Definitions.--In this section:
(1) The term ``Part 2 program'' means a program described
in section 543 of the Public Health Service Act (42 U.S.C.
290dd-2).
(2) The term ``Part 2'' means the program under section 543
of the Public Health Service Act (42 U.S.C. 290dd-2).
Mr. PALLONE (during the reading). Mr. Speaker, I ask unanimous
consent to dispense with the reading of the motion.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from New Jersey?
There was no objection.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from New
Jersey is recognized for 5 minutes in support of his motion.
Mr. PALLONE. Mr. Speaker, this is the final amendment to the bill
which will not kill the bill or send it back to committee. If adopted,
the bill will immediately proceed to final passage, as amended.
Mr. Speaker, this amendment would maintain the privacy rights
provided to individuals with substance use disorder. Those patients
would retain their right to determine with whom and for what purpose to
share their substance use disorder treatment records from part 2
programs.
Rather than strip away patients' privacy rights, my amendment would
incorporate section 509 from the bipartisan Alexander-Murray bill, S.
2680, the Opioid Crisis Response Act of 2018, that was reported out of
the Senate HELP Committee on a bipartisan basis, and that was
incorporated in the underlying legislation.
That provision requires the Secretary to support the development and
dissemination of model training programs for substance use disorder
treatment records under part 2. It would help ensure that more
patients, families, and providers understand how information can be
protected and shared under part 2.
My amendment would also help us to better understand the privacy
needs of individuals with substance use disorder as well as how to
balance those needs with the information needs of our health system to
provide the highest quality care.
Specifically, my amendment would require the Secretary to conduct or
support a study to better understand the patient experience with part 2
through the examination of information-sharing behaviors of individuals
who obtain substance use disorder treatment at part 2 programs.
This study will provide critical insight into the central question
under debate today: What is the appropriate level of privacy
protections that should be applied to substance use disorder treatment
records?
While there are a lot of opinions and persuasive evidence to support
both sides of this debate, there is a lack of research on this issue
generally or as it specifically relates to part 2. Such information
will help us better understand the level of control individuals with
substance use disorders need over their medical records to ensure their
privacy concerns are not a barrier for such individuals accessing
potentially lifesaving treatment.
It would also help us better understand what is the appropriate
balance between the needs of these individuals regarding the privacy of
their substance use disorder treatment information with the needs of a
coordinated healthcare system to best serve its patients.
We know that today, under current law, some patients who receive
substance use disorder treatment from part 2 programs choose not to
share their treatment records with any provider outside of their
substance use disorder treatment provider. On the other hand, there are
others who choose to share with only a few of their nonsubstance use
disorder treatment providers.
So I just believe it is critical we understand the reasons why such
individuals have made these decisions as well as how the right to make
such a decision affected their willingness to seek or remain in
treatment.
This amendment is consistent with the recent recommendations from the
Medicaid and CHIP Payment and Access Commission. As part of their June
2018 report to Congress, the commission stated that at this time the
commission does not recommend alignment of part 2 and HIPAA. Instead,
the commission recommends additional subregulatory guidance, education,
and training on part 2.
As I have made clear, Mr. Speaker, I have concerns that the
underlying bill would hurt our efforts to respond to the opioid
epidemic and could increase the odds that fewer individuals with opiate
use disorder enter and remain in treatment, a risk I believe too great
to take during the worst drug abuse epidemic our country has ever
faced.
However, I realize there is another side of this argument as advanced
by the proponents of this bill, and we should not be concerned that
this bill will affect the uptick of treatment, and, in fact, we should
believe that this will only improve treatment.
Rather than undertake the 50-State experiment to see which side is
right, we should support the thorough study of this issue before taking
any action to weaken the privacy protections provided by part 2. In
that way, we can determine the actual effect on taking away from
individuals with substance use disorder the ability to decide how their
treatment information is shared. That way we would have no doubt on
both the intended and unintended consequences of eliminating the
patient consent requirement for treatment, payment, and healthcare
operation purposes as proposed by the underlying bill.
I think the stakes are too high to get this wrong. I urge my
colleagues to support this amendment to increase the awareness of
patients, families, and providers about how their treatment records are
protected and can be shared under part 2 as well as to increase our
understanding of the privacy needs of individuals with substance use
disorders.
I yield back the balance of my time, Mr. Speaker.
Mr. BURGESS. Mr. Speaker, I withdraw my point of order.
The SPEAKER pro tempore. The reservation of the point of order is
withdrawn.
[[Page H5335]]
Mr. BURGESS. Mr. Speaker, I claim the time in opposition to the
motion.
The SPEAKER pro tempore. The gentleman from Texas is recognized for 5
minutes.
Mr. BURGESS. Mr. Speaker, I urge a ``no'' vote on the motion to
recommit as it will destroy the intent of the bill.
Eliminating the sharing of records for the purposes of treatment,
payment, and healthcare operations completely negates the entire
purpose of this initiative.
Aligning 42 CFR part 2 with HIPAA for purposes of treatment, payment,
and healthcare operations is the entire purpose of the legislation.
Opponents of this bill have offered no evidence or findings to back
up their claim that HIPAA is inadequate to protect sensitive data
contained in substance use disorder treatment records.
HIPAA is currently functioning well in protecting sensitive patient
information in a number of areas.
Real integration of behavioral health and primary care simply cannot
happen until we align 42 CFR part 2 with HIPAA.
The opposition of H.R. 6082 is not based on protecting privacy. It is
based on very specific distrust of the healthcare community to properly
provide care to people with substance use disorder--the very people
whom we are asking to help us with this.
Yet, the ranking member is strongly in favor of numerous bills that
seek to expand access to evidence-based medication-assisted treatment,
telehealth and integration with mainstream medicine--the very things
that demand alignment with HIPAA. So the thinking, Mr. Speaker, to be
kind, is incongruous.
Prohibiting the sharing of addiction medical records for treatment,
payment, and healthcare operations makes it impossible to prescribe the
latest substance use treatment medications safely.
Like most pharmaceuticals, buprenorphine and methadone have drug
interactions and interact with other medicines. Adverse events from
drug interactions can lead to emergency hospital visits, serious
injuries, or death.
We must amend part 2 so we can safely prescribe medication-assisted
treatment for patients. Put simply, standard clinical practices like
medication reconciliation are not feasible under the current Federal
law. For that reason, I urge my colleagues to vote ``no'' on the motion
to recommit. Vote ``yes'' on the underlying motion.
Mr. Speaker, I yield back the balance of my time.
The SPEAKER pro tempore. Without objection, the previous question is
ordered on the motion to recommit.
There was no objection.
The SPEAKER pro tempore. The question is on the motion to recommit.
The question was taken; and the Speaker pro tempore announced that
the noes appeared to have it.
Mr. PALLONE. Mr. Speaker, on that I demand the yeas and nays.
The yeas and nays were ordered.
The SPEAKER pro tempore. Pursuant to clause 8 of rule XX, further
proceedings on this question will be postponed.
____________________