[House Hearing, 115 Congress]
[From the U.S. Government Publishing Office]


   IMPROVING THE COORDINATION AND QUALITY OF SUBSTANCE USE DISORDER 
                               TREATMENT

=======================================================================

                                HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED FIFTEENTH CONGRESS

                             SECOND SESSION

                               __________

                              MAY 8, 2018

                               __________

                           Serial No. 115-126
                           
                           

[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]                           


      Printed for the use of the Committee on Energy and Commerce

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                    COMMITTEE ON ENERGY AND COMMERCE

                          GREG WALDEN, Oregon
                                 Chairman
JOE BARTON, Texas                    FRANK PALLONE, Jr., New Jersey
  Vice Chairman                        Ranking Member
FRED UPTON, Michigan                 BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois               ANNA G. ESHOO, California
MICHAEL C. BURGESS, Texas            ELIOT L. ENGEL, New York
MARSHA BLACKBURN, Tennessee          GENE GREEN, Texas
STEVE SCALISE, Louisiana             DIANA DeGETTE, Colorado
ROBERT E. LATTA, Ohio                MICHAEL F. DOYLE, Pennsylvania
CATHY McMORRIS RODGERS, Washington   JANICE D. SCHAKOWSKY, Illinois
GREGG HARPER, Mississippi            G.K. BUTTERFIELD, North Carolina
LEONARD LANCE, New Jersey            DORIS O. MATSUI, California
BRETT GUTHRIE, Kentucky              KATHY CASTOR, Florida
PETE OLSON, Texas                    JOHN P. SARBANES, Maryland
DAVID B. McKINLEY, West Virginia     JERRY McNERNEY, California
ADAM KINZINGER, Illinois             PETER WELCH, Vermont
H. MORGAN GRIFFITH, Virginia         BEN RAY LUJAN, New Mexico
GUS M. BILIRAKIS, Florida            PAUL TONKO, New York
BILL JOHNSON, Ohio                   YVETTE D. CLARKE, New York
BILLY LONG, Missouri                 DAVID LOEBSACK, Iowa
LARRY BUCSHON, Indiana               KURT SCHRADER, Oregon
BILL FLORES, Texas                   JOSEPH P. KENNEDY, III, 
SUSAN W. BROOKS, Indiana                 Massachusetts
MARKWAYNE MULLIN, Oklahoma           TONY CARDENAS, California
RICHARD HUDSON, North Carolina       RAUL RUIZ, California
CHRIS COLLINS, New York              SCOTT H. PETERS, California
KEVIN CRAMER, North Dakota           DEBBIE DINGELL, Michigan
TIM WALBERG, Michigan
MIMI WALTERS, California
RYAN A. COSTELLO, Pennsylvania
EARL L. ``BUDDY'' CARTER, Georgia
JEFF DUNCAN, South Carolina
                         Subcommittee on Health


                       MICHAEL C. BURGESS, Texas
                                 Chairman
BRETT GUTHRIE, Kentucky              GENE GREEN, Texas
  Vice Chairman                        Ranking Member
JOE BARTON, Texas                    ELIOT L. ENGEL, New York
FRED UPTON, Michigan                 JANICE D. SCHAKOWSKY, Illinois
JOHN SHIMKUS, Illinois               G.K. BUTTERFIELD, North Carolina
MARSHA BLACKBURN, Tennessee          DORIS O. MATSUI, California
ROBERT E. LATTA, Ohio                KATHY CASTOR, Florida
CATHY McMORRIS RODGERS, Washington   JOHN P. SARBANES, Maryland
LEONARD LANCE, New Jersey            BEN RAY LUJAN, New Mexico
H. MORGAN GRIFFITH, Virginia         KURT SCHRADER, Oregon
GUS M. BILIRAKIS, Florida            JOSEPH P. KENNEDY, III, 
BILLY LONG, Missouri                     Massachusetts
LARRY BUCSHON, Indiana               TONY CARDENAS, California
SUSAN W. BROOKS, Indiana             ANNA G. ESHOO, California
MARKWAYNE MULLIN, Oklahoma           DIANA DeGETTE, Colorado
RICHARD HUDSON, North Carolina       FRANK PALLONE, Jr., New Jersey (ex 
CHRIS COLLINS, New York                  officio)
EARL L. ``BUDDY'' CARTER, Georgia
GREG WALDEN, Oregon (ex officio)
  
                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Michael C. Burgess, a Representative in Congress from the 
  State of Texas, opening statement..............................     1
    Prepared statement...........................................     3
Hon. Gene Green, a Representative in Congress from the State of 
  Texas, opening statement.......................................     4
    Prepared statement...........................................     5
Hon. Greg Walden, a Representative in Congress from the State of 
  Oregon, opening statement......................................     6
    Prepared statement...........................................     8
Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, opening statement.........................     9
    Prepared statement...........................................    11

                               Witnesses

Earl Blumenauer, A Representative in Congress from the State of 
  Oregon.........................................................    12
    Prepared statement...........................................    14
Dustin McKee, Director of Policy, The National Alliance on Mental 
  Illness of Ohio................................................    18
    Prepared statement...........................................    20
Patty McCarthy Metcalf, Executive Director, Faces and Voices of 
  Recovery.......................................................    23
    Prepared statement...........................................    25
Jeremiah Gardner, Manager of Public Affairs and Advocacy, 
  Hazelden Betty Ford Foundation.................................    32
    Prepared statement...........................................    34
H. Westley Clark, M.D., J.D., M.P.H., The Dean's Executive 
  Professor, Public Health Program, Santa Clara University.......    41
    Prepared statement...........................................    43
    Answer to submitted question.................................   289
Gerald (Jud) E. Deloss, Officer, Greensfelder, Hemker and Gale, 
  P.C............................................................    57
    Prepared statement...........................................    59

                           Submitted Material

Statement of the Oregon Association of Hospitals and Health 
  Systems, submitted by Mr. Burgess..............................   113
CMS brief entitled, ``Designing Medicaid Health Homes for 
  Individuals with Opiate Dependency: Considerations for 
  States,'' January 2015, submitted by Mr. Lance.................   114
Burgess documents
    Op-Ed entitled, ``People with addiction issues should be able 
      to control their own health data,'' The Hill, March 21, 
      2018.......................................................   121
    Statement of Magellan Health.................................   126
    Statement of the Healthcare Leadership Council...............   132
    Statement of the Substance Abuse and Mental Health Services 
      Administration.............................................   134
    Statement of America's Essential Hospitals...................   136
    Statement of the American Society of Addiction Medicine......   141
    Statement of the National Association of State Mental Health 
      Program Directors..........................................   152
    Statement of the American Association on Health and 
      Disability.................................................   154
    Statement of the National Alliance on Mental Illness.........   156
    Statement of the American Hospital Association...............   158
    Statement of the Academy of Managed Care Pharmacy............   160
    Statement of Avera...........................................   162
    Statement of OCHIN, Inc......................................   163
    Statement of the Pharmaceutical Care Management Association..   164
    Statement of Shatterproof....................................   172
    Statement of Trinity Health..................................   176
    Statement of the Association for Behavioral Health and 
      Wellness...................................................   183
    Statement of Mental Health America...........................   185
    Statement of the National Association of Medicaid Directors..   187
    Statement of the American Health Information Management 
      Association................................................   190
    Statement of the Blue Cross Blue Shield Association..........   192
    Statement of the Association for Community Affiliated Plans..   194
    Statement of the Hazelden Betty Ford Foundation..............   196
    Statement of Centerstone.....................................   200
    Statement of the Premier Healthcare Alliance.................   202
    Statement of the Catholic Health Association.................   205
    Statement of the College of Healthcare Information Management 
      Executives.................................................   207
    Statement of the Partnership to Amend Part 2.................   209
    Statement of the Confidentiality Coalition...................   211
    Statement of the Port Gamble Tribe...........................   213
    Statement of the American Psychiatric Association............   230
    Joint statement of the National Association of ACOs, Premier, 
      and the American Medical Group Association.................   236
Green documents
    Statement of the National Advocates for Pregnant Women.......   238
    the National Association for Children of Addiction...........   242
    Statement of the Opioid Treatment Association of Rhode Island   244
    Statement of the Ringgold Treatment Center, LLC..............   246
    Statement of Victory Clinical Services.......................   248
    Statement of Recovery Network of Programs, Inc...............   250
    Statement of the South Carolina Association for the Treatment 
      of Opioid Dependence.......................................   252
    Statement of Northern Parkway Treatment Services Incorporated   254
    Statement of BH Health Services..............................   256
    Statement of Serenity Health, LLC............................   257
    Statement of the Kentucky Mental Health Coalition............   260
    Statement of the President of the Kentucky Association for 
      the Treatment of Opioid Dependence.........................   262
    Statement of People Advocating Recovery......................   264
    Statement of the Long Island Recovery Association............   266
    Statement of Faces & Voices of Recovery......................   268
    Statement of Pennsylvania Recovery Organizations Alliance....   271
    Statement of the Campaign to Protect Patient Privacy Rights..   274
    Statement of the National Council on Alcoholism and Drug 
      Dependence of the San Fernando Valley......................   280
    Statement of Futures Without Violence........................   282
    Statement of Sally Carr, parent of a son with addiction and 
      representative of Never Surrender Hope.....................   284
    Statement of Lauren Wicks, National Independent Family 
      Recovery Advocate..........................................   285
    Statement of the National Association for Children of 
      Addiction..................................................   287

 
   IMPROVING THE COORDINATION AND QUALITY OF SUBSTANCE USE DISORDER 
                               TREATMENT

                              ----------                              


                          TUESDAY, MAY 8, 2018

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 1:05 p.m., in 
room 2123, Rayburn House Office Building, Hon. Michael Burgess, 
M.D. (chairman of the subcommittee) presiding.
    Present: Representatives Burgess, Guthrie, Barton, 
Blackburn, Latta, Lance, Griffith, Bilirakis, Long, Bucshon, 
Brooks, Mullin, Hudson, Collins, Carter, Walden (ex officio), 
Green, Engel, Matsui, Castor, Sarbanes, Kennedy, Eshoo, 
Degette, and Pallone (ex officio).
    Staff Present: Mike Bloomquist, Staff Director; Daniel 
Butler, Staff Assistant; Zachary Dareshori, Legislative Clerk, 
Health; David DeMarco, IT Staff; Paul Edattel, Chief Counsel, 
Health; Ed Kim, Policy Coordinator, Health; Caprice Knapp, 
Fellow, Health; Drew McDowell, Executive Assistant; James 
Paluskiewicz, Professional Staff, Health; Kristen Shatynski, 
Professional Staff Member, Health; Jennifer Sherman, Press 
Secretary; Austin Stonebraker, Press Assistant; Hamlin Wade, 
Special Advisor, External Affairs; Jeff Carroll, Minority Staff 
Director; Waverly Gordon, Minority Health Counsel; Tiffany 
Guarascio, Minority Deputy Staff Director and Chief Health 
Advisor; Samantha Satchell, Minority Senior Policy Analyst; and 
C.J. Young, Minority Press Secretary.

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE 
              IN CONGRESS FROM THE STATE OF TEXAS

    Mr. Burgess. The Subcommittee on Health will now come to 
order. The chair recognizes himself for 5 minutes for the 
purpose of an opening statement.
    Over the past several months, this subcommittee has held 
hearings to evaluate bills to address the opioid epidemic. We 
have also favorably reported 57 bills to the full Energy and 
Commerce Committee. Today, we are here to discuss a bill that 
would make timely reforms to a privacy law that affects patient 
access to healthcare and creates, in some minds, barriers to 
treatment: the Overdose Prevention and Patient Safety Act. This 
hearing is an important opportunity for us to gain a better 
understanding of Federal privacy laws and how they function in 
the healthcare system.
    As a physician, I believe that it is vital that when we are 
making clinical decisions, you need all the appropriate 
information to make the correct determination in the treatment 
of the patient. Suffering from a substance use disorder should 
receive the same level of treatment and care as other 
individuals. Patients affected with substance use disorder 
deserve to be treated by physicians who are armed with all the 
necessary information to provide the best of care. I certainly 
do understand and respect that privacy protection is paramount 
and should be held to the highest regard. The Overdose 
Prevention and Patient Safety Act maintains the original intent 
of the 1970 statute behind 42 CFR Part 2 by protecting patients 
and improving care coordination. In fact, Mr. Mullin's bill 
increases protections for those seeking treatment by more 
severely penalizing those who breach that patient data 
standard.
    The issue of the stigma associated with substance use 
disorder has been a constant in all the discussions we have 
had, both in our offices and in hearings. We have dedicated 
months of our time to putting together legislation to help 
break the stigma and help individuals with this complex disease 
gain access to healthcare and support services critical to 
getting them on the road to recovery. The first step in 
addressing this problem is admitting that it exists. If we 
continue to silo the substance use disorder treatment 
information from a select group of patients rather than 
integrating it into medical records and comprehensive care 
models, it is hard to see how we can ensure that these patients 
are receiving quality care. Physicians, unknowing of a 
patient's substance use disorder, may prescribe medications 
that have significant drug interactions, or worse, they may 
prescribe controlled substances and make the patient's 
substance use disorder significantly worse. As it currently 
stands, 42 CFR Part 2 is actively prohibiting physicians from 
ensuring proper treatment and patient safety while perpetuating 
stigma.
    At our second opioid hearing held this March, we brought 
this bill up for consideration and openly debated the privacy 
concerns with experts and expert witnesses and the Health 
Subcommittee members. Additionally, panelists at our recent 
roundtable discussion with families who had been affected by 
the opioid epidemic echoed the need for reforming current law.
    As we all know, providing high-quality healthcare is a team 
effort. Physicians do lead that team, but it is necessary that 
physicians have the necessary information to adequately 
coordinate care. We must align payment operations and treatment 
to allow coordination of both behavioral and physical health 
services for individuals with substance use disorder.
    I recently heard from a hospital in my district that 
mentioned that there is some likelihood that Part 2, as it 
currently stands, could be a disincentive for healthcare 
systems seeking to open additional addiction treatment centers 
due to the problems that the law creates, particularly the 
sequestration of patient information from their hospital.
    There is a reason why the Substance Abuse and Mental Health 
Services Administration and most of the health stakeholder 
community is asking for this change. Clearly, there is an issue 
here that must be addressed. This crisis, this opiate crisis, 
is devastating our country. Our action is important to the 
families and communities and to our constituents who are 
impacted by this epidemic.
    I want to thank all of our witnesses who are here today and 
look forward to their testimony. And I will yield the balance 
of my time to the gentlelady from Tennessee.
    [The prepared statement of Mr. Burgess follows:]

             Prepared statement of Hon. Michael C. Burgess

    In the past few months, this Subcommittee has held three 
hearings to evaluate bills to address this opioid epidemic. We 
have also favorably reported 57 bills to the full Energy and 
Commerce Committee. Today, for the second time, we are here to 
discuss a bill that would make timely reforms to a privacy law 
that affects patient access to health care and creates barriers 
to treatment--the Overdose Prevention and Patient Safety Act. 
This hearing is an important opportunity for us to gain a 
better understanding of federal privacy laws and how they 
function in the healthcare delivery system.
    As a physician, I believe that it is vital that when making 
clinical decisions, I have all of the appropriate information 
to make the correct determination in the treatment of a 
patient. Those suffering from substance use disorder should 
receive the same level of treatment and care as other 
individuals. Patients afflicted with substance use disorder 
deserve to be treated by physicians who are armed with all of 
the necessary information to provide the best care. I certainly 
do understand and respect that patient privacy protection is 
paramount and should be held to the highest regard. 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, 
Mr. Mullin's bill increases protections for those seeking 
treatment by more severely penalizing those who share patient 
data than under the current statute.
    The issue of the stigma associated with substance use 
disorder has been a constant in all discussions we have had, 
both in our offices and in our hearings. We have dedicated 
months of our time to putting together legislation to help 
break stigma and help individuals with this complex disease 
gain access to health care and support services critical to 
getting them on the road to recovery. The first step in 
addressing a problem is admitting that it exists. 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 these patients are receiving quality 
care? Physicians, unknowing of a patient's substance use 
disorder, may prescribe medications that have significant drug 
interactions, or worse, may prescribe controlled substances 
that make their patient's substance use disorder worse. As it 
currently stands, 42 CFR Part 2 is actively prohibiting 
physicians from ensuring proper treatment and patient safety 
while perpetuating stigma.
    At our second opioid hearing held in March, we brought this 
bill up for consideration and openly debated privacy concerns 
with expert witnesses and amongst health subcommittee members. 
Additionally, panelists at our recent roundtable discussion 
with victims of the opioid epidemic echoed the need for 
reforming the current law.
    As we all know, providing high quality health care is a 
team effort. Physicians are leading that team, but it is 
necessary that physicians have the necessary information to 
adequately coordinate care. We must align payment, operations, 
and treatment to allow coordination of both behavioral and 
physical health services for individuals with substance use 
disorder.
    In fact, I recently heard from a hospital in my district 
that mentioned that there is some likelihood that Part 2, as it 
currently stands, could be a disincentive for health care 
systems seeking to open addiction treatment centers due to the 
problems the law creates, particularly the sequestration of 
patient information from their hospital.
    There's a reason why SAMHSA and most of the health 
stakeholder community is asking for this change. Clearly, there 
is an issue here that must be addressed. This opioid crisis is 
devastating our country. Our action is important to the 
families and communities--our constituents--impacted by the 
opioid epidemic.
    I thank all the witnesses here today and look forward to 
their testimony.
    I would now like to yield the balance of my time to the 
gentlelady from Tennessee.

    Mrs. Blackburn. Thank you, Mr. Chairman.
    And I thank you for having this hearing and for listening 
to us as we have brought the concerns forward with Part 2. This 
is something that has become a barrier to many people that are 
in treatment to get the full access to comprehensive care that 
they need to be able to fully recover.
    And I have spent a good bit of time the past few years 
doing roundtables and visiting treatment centers and talking 
with families that are covered--and I come at this as a mother 
and a grandmother and a friend, and having individuals close to 
me who have those in their family, in their circle that have 
suffered from addiction.
    So thank you for this. Thank you for the attention to this 
issue. I look forward to the hearing.
    I yield back.
    Mr. Burgess. The gentlelady yields back.
    The chair yields back. The chair recognizes the ranking 
member of the subcommittee, Mr. Green of Texas, 5 minutes for 
your opening statement, please.

   OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF TEXAS

    Mr. Green. Thank you, Chairman, for holding today's hearing 
on substance use disorder treatment and 42 CFR Part 2.
    Ranking Member Pallone and I requested a hearing on 42 CFR 
Part 2 last month, and I appreciate the majority's willingness 
to hold a hearing on this important issue.
    Title 42 of the Code of Federation Regulations Part 2 are 
the implementing regulations of the two laws Congress passed in 
the early 1970s to protect individuals who seek treatment for 
substance abuse.
    According to the Substance Abuse and Mental Health 
Administration, SAMHSA, the purpose of 42 CFR Part 2 is ``to 
ensure that a patient receiving treatment for a substance use 
disorder in the Part 2 program is not made more vulnerable by 
reason of the availability of their patient record than an 
individual with substance use disorder who does not seek 
treatment.''
    I agree with SAMHSA. Americans suffering from substance 
abuse should not become more vulnerable for doing the right 
thing and seeking treatment.
    42 CFR Part 2 provides individuals receiving substance use 
disorder treatment with the privacy they need to guard against 
the negative consequences of unauthorized release of their drug 
or alcohol patient information, such as the loss of child 
custody, parental rights, the loss of a job, denial of 
healthcare, possible exclusion from public housing, possible 
criminal justice consequences, including arrest and 
prosecution.
    SAMHSA in recent years has revised Part 2 in order to 
improve coordination among providers providing treatment to 
individuals suffering from substance abuse. The provisions 
expand the ability of providers to share information about a 
patient with a substance use disorder as well as allow new 
consent options for disclosure but continue to maintain Part 
2's core protections.
    In 2017, treating provider relationships were allowed under 
certain circumstances, such as providing information to 
entities that agree to provide diagnosis, treatment, 
evaluation, and consultation with a patient.
    As we work to balance the privacy needs of the individual 
seeking substance abuse treatment, we also need to ensure that 
providers are able to access needed information in order to 
properly provide them with the treatment they need.
    I want to make sure that, in an effort to improve 
coordination of care, we do not sacrifice the rights of 
individuals seeking needed treatment for their addiction.
    We have spent the past few months working on addressing the 
opioid crisis and have learned from medical professionals that 
only a small fraction of Americans suffering from substance 
abuse seek treatment, in part out of fear that their medical 
records may be disclosed.
    Current law allows for the disclosure of information under 
Part 2 with regard to internal communications, medical 
emergencies, special court orders, in the event of a crime on 
the premises or against personnel on the premises, and entities 
covered under Part 2, qualified service organization and 
business associate agreements.
    Before our committee moves forward with the Overdose 
Prevention and Patient Safety Act, H.R. 3545, we need to make 
sure that the rights and privacy of patients seeking treatment 
are protected.
    I am open to considering changes to Part 2, but these 
changes need to meet the current standard of protection that 
protect Americans seeking substance abuse treatment.
    Mr. Chairman, I yield back the balance of my time.
    [The prepared statement of Mr. Green follows:]

                 Prepared statement of Hon. Gene Green

    Thank you, Mr. Chairman, for holding today's hearing on 
substance use disorder treatment and 42 CFR Part 2.
    Ranking Member Pallone and I requested a hearing on 42 CFR 
Part 2 last month and I appreciate the Majority's willingness 
to hold a hearing on this important issue.
    Title 42 of the Code of Federal Regulations Part 2 are the 
implementing regulations of two laws Congress passed in the 
early 1970s to protect individuals who seek treatment for 
substance abuse.
    According to the Substance Abuse and Mental Health 
Administration (SAMHSA), the purpose of 42 CFR Part 2 is ``to 
ensure that a patient receiving treatment for a substance use 
disorder in a Part 2 program is not made more vulnerable by 
reason of the availability of their patient record than an 
individual with a substance use disorder who does not seek 
treatment.''
    I agree with SAMHA. Americans suffering from substance 
abuse should not become more vulnerable for doing the right 
thing and seek treatment.
    42 CFR Part 2 provides individuals receiving substance use 
disorder treatment with the privacy they need to guard against 
the negative consequences of unauthorized release of their drug 
or alcohol patient information, such as the loss of child 
custody and parental rights, the loss of a job, denial of 
health care, possible exclusion from public housing and 
possible criminal justice consequences, including arrest and 
prosecution.
    SAMHSA, in recent years, has revised Part 2 in order to 
improve coordination among providers providing treatment to 
individuals suffering from substance abuse. The revisions 
expand the ability of providers to share information about a 
patient with a substance use disorder as well as allow new 
consent options for disclosure, but continue to maintain Part 
2's core protections.
    In 2017, treating provider relationships were allowed under 
certain circumstances such as providing information to entities 
that agree to provide diagnosis, treatment, evaluation or 
consultation with the patient.
    As we work to balance the privacy needs of individuals 
seeking substance abuse treatment, we also need to ensure that 
providers are able to access needed information in order to 
properly provide them with the treatment they need.
    I want to make sure that in an effort to improve 
coordination of care, we do not sacrifice the rights of 
individuals seeking needed treatment for their addiction.
    We have spent the past few months working on addressing the 
opioid crisis and have learned from medical professionals that 
only a small fraction of Americans suffering from substance 
abuse seek treatment, in part out of fear that their medical 
records may be disclosed.
    Current law allows for the disclosure of information under 
Part 2 with regard to internal communications, medical 
emergencies, special court orders, in the event of a crime on 
the premises or against personnel on the premises of entities 
covered under Part 2, and qualified service organization and 
business associate agreements.
    Before our committee moves forward on the Overdose 
Prevention and Patient Safety Act, H.R. 3545, we need to make 
sure the rights and privacy of patients seeking treatment are 
protected.
    I am open to considering changes to Part 2, but these 
changes need to meet the current standard of protection that 
protect Americans seeking substance abuse treatment.
    I would now like to yield one minute to my colleague, 
Congresswoman Matsui of California.

    Mr. Burgess. The chair thanks the gentleman.
    The chair recognizes the gentleman from Oregon, the 
chairman of the full committee, Mr. Walden, for 5 minutes.

  OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF OREGON

    Mr. Walden. Thank you very much, Mr. Chairman. Again, thank 
you for your leadership on this and so many other healthcare 
issues.
    Today marks our fourth Health legislative hearing on 
solutions to address the opioid crisis, an epidemic that knows 
no geographic, political, or socioeconomic bounds. Throughout 
this process, part of this committee's approach has been to 
shift attitudes towards substance use disorder and treatment. 
As I have stated before, substance use disorder is a medical 
illness, and we must treat it that way. Removing the stigma of 
addiction is one of the most important things we, as Members of 
Congress can do to respond to the national emergency, and it 
will dramatically change how we prevent and treat this complex 
issue.
    During our work to develop policies to stem the tide of 
addiction and abuse, an extraordinary array of hospitals, 
physicians, patient advocates and substance use disorder 
treatment providers have approached this committee to clearly 
state that existing Federal confidentiality regulations, known 
as 42 CFR Part 2, or ``Part 2,'' are interfering with case 
management and care coordination to effectively treat substance 
use disorder.
    The statute behind Part 2 was enacted more than 20 years 
ago, 20 years before the Health Insurance Portability Act, or 
HIPAA, and 40 years prior to the use of electronic healthcare 
records. The intent behind Part 2 was to protect patients 
seeking treatment from negative repercussions, such as 
incarceration or loss of employment, laudable goals. And yet, 
Part 2 does not even apply to all substance abuse disorder 
patients, meaning some providers have full access to a 
patient's medical records and others don't.
    For the millions of patients suffering from substance use 
disorder who are treated by a provider not subject to Part 2, 
their records are protected by HIPAA. Now, this begs the 
following question: Is HIPAA protective enough for those 
seeking substance use disorder treatment or not? If it is not, 
what can we do to better protect patient privacy and better 
coordinate substance use disorder treatment? Because, as 
currently written, the statute behind Part 2 handcuffs 
providers, and it hurts patients.
    Representatives Mullin and Blumenauer have tackled this 
complex issue and written the Overdose Prevention and Patient 
Safety Act, which I believe strikes the right balance of 
maintaining and strengthening patient protections while 
allowing for the limited sharing of substance use disorder 
treatment records between healthcare providers, plans, and 
clearinghouses.
    The legislation also includes strong penalties and 
discrimination prohibitions in statute to protect people 
seeking and receiving substance use disorder treatment. I have 
heard from providers in Oregon, from hospitals to healthcare 
centers to addiction specialists, who believe these changes are 
critical to their improving treatment of substance use 
disorder.
    In fact, Mr. Chairman, I have a letter for the record from 
the Oregon Hospital Association commending our efforts I would 
like inserted, without objection.
    Mr. Burgess. Without objection, so ordered.
    [The information appears at the conclusion of the hearing.]
    Mr. Walden. So I understand this issue is a sensitive one. 
There have been a lot of discussions. There has been a lot of 
confusion, understandably so, about what this bill does or 
doesn't do, which is why we are having this extra hearing. 
Privacy law is complex, which is why we are having additional 
testimony in addition to what we heard in March. So we are here 
to learn more about this issue, to listen to stakeholders on 
both sides of the argument. It is important we have a 
thoughtful discussion and get to the bottom of this.
    The Ranking Member has made clear that he will evaluate 
bills based on two principles: One, whether the proposal 
improves access to treatment for opioid use disorders; and, 
two, whether the proposal helps to prevent people from getting 
addicted to opioids in the first place. I would argue that the 
Overdose Prevention and Patient Safety Act does both. Treating 
patients' substance use disorder in isolation from their 
medical conditions, which predominated care in the 1970s, is 
not the standard of good medical practice today.
    This legislation will arm physicians with all the necessary 
information to provide the best care, ultimately improving 
access to treatment and preventing the unnecessary prescribing 
of substances that may cause patient harm.
    With that, Mr. Chairman, I would turn the remainder of my 
time to Mr. Mullin of Oklahoma, the leader on this issue for 
this committee.
    [The prepared statement of Mr. Walden follows:]

                 Prepared statement of Hon. Greg Walden

    Today marks our fourth health legislative hearing on 
solutions to address the opioid crisis, an epidemic that knows 
no geographic, political, or socio-economic bounds. Throughout 
this process, part of this committee's approach has been to 
shift attitudes toward substance use disorder. As I have stated 
before, substance use disorder is a medical illness and we must 
treat it that way. Removing the stigma of addiction is one of 
the most important things we as members of Congress can do to 
respond to this national emergency and will dramatically change 
how we prevent and treat this complex disease.
    During our work to develop policies to stem the tide of 
addiction and abuse, an extraordinary array of hospitals, 
physicians, patient advocates, and substance use disorder 
treatment providers have approached this committee to clearly 
state that existing federal confidentiality regulations, know 
as 42 CFR Part 2 or ``Part 2'', are interfering with case 
management and care coordination to effectively treat substance 
use disorder.
    The statute behind Part 2 was enacted more than 20 years 
before Health Insurance Portability and Accountability Act, or 
HIPAA, and 40 years prior to the use of electronic health care 
records. The intent behind Part 2 was to protect patients 
seeking treatment from negative repercussions, such as 
incarceration and loss of employment. And yet, Part 2 doesn't 
even apply to all substance use disorder patients, meaning that 
some providers have full access to a patients' medical record 
while others do not.
    For the millions of patients suffering from substance use 
disorder who are treated by a provider not subject to Part 2, 
their records are protected by HIPAA. This begs the following 
questions--is HIPAA protective enough for those seeking 
substance use disorder treatment or not? If it is not, what can 
we do to better protect patient privacy and better coordinate 
substance use disorder treatment? Because as currently written, 
the statute behind Part 2 handcuffs providers and hurts 
patients.
    Representative Mullin and Representative Blumenauer have 
tackled this complex issue and written the Overdose Prevention 
and Patient Safety Act, which I believe strikes the right 
balance of maintaining and strengthening patient protections, 
while allowing for the limited sharing of substance use 
disorder treatment records between health providers, plans and 
clearinghouses.
    The legislation also includes strong penalties and 
discrimination prohibitions in statute to protect people 
seeking and receiving substance use disorder treatment. I have 
heard from providers in Oregon, from hospitals to health 
centers to addiction specialists, who believe these changes are 
critical to their improving treatment of substance use 
disorder.
    I understand this issue is a sensitive one. There has been 
a lot of discussion and confusion about what this bill does and 
does not do. Privacy law is complex, which is why we are having 
another hearing in addition to the testimony we heard on this 
issue in March. We are here to learn more about this issue and 
listen to stakeholders on both sides of the argument. It is 
important that we have a thoughtful discussion about ensuring 
that patients seeking these services receive privacy 
protections, parity and the same quality treatment that is 
provided to patients with other chronic disorders.
    The Ranking Member has made clear that he will evaluate 
bills based on two principles: One, whether the proposal 
improves access to treatment for opioid use disorders; or two, 
whether the proposal helps to prevent people from getting 
addicted to opioids in the first place. I would argue that the 
Overdose Prevention and Patient Safety Act does both. Treating 
patients' substance use disorder in isolation from their 
medical conditions, which predominated care in the 1970s, is 
not the standard of good medical practice today.
    This legislation will arm physicians with all of the 
necessary information to provide the best care, ultimately 
improving access to treatment and preventing the unnecessary 
prescribing of substances that may cause harm to a patient.
    Thank you to our witnesses for joining us today. I look 
forward to hearing your insights on this important bipartisan 
legislation, and furthering our efforts to combat the opioid 
crisis.

    Mr. Mullin. Thank you, Mr. Chairman.
    And thank you, Chairman Burgess, for allowing us to have 
this hearing today and for all the witnesses. Congressman 
Blumenauer and myself, we don't typically agree on a whole lot, 
but when we start talking about this, we do agree 100 percent 
on this issue.
    This is about allowing the physicians to be able to see the 
complete record and be able to treat the patient as a whole, 
not just part. This is about destigmatizing what addictions 
really mean. It allows us to bring us back into the 21st 
century. When Part 2 was first put up there, the medical field 
looked completely different than it does now. So, without Part 
2 alignment, we are going to continue to stigmatize patients 
with substance use disorder.
    I urge all my colleagues today to take a look at how we can 
bring substance use disorder treatment and the rules and laws 
governing them into the 21st century. It is simple. We want to 
take care of the patients. The doctors want to take care of the 
patients. We need to move forward. This is something that has 
hit all of us personally.
    With that, Mr. Chairman, I yield back.
    Mr. Walden. And I yield back.
    Mr. Burgess. The chair thanks the gentleman. The chair 
observes that there are a series of votes on the floor, so we 
are going to recess while we attend to those votes on the 
floor. We will reconvene immediately after the last votes and 
hear from the ranking member of the subcommittee, Mr. Pallone, 
for his opening statement.
    The committee stands in recess.
    [Recess.]
    Mr. Burgess. I will call the Committee back to order. When 
the Committee recessed for votes, we were in the process of 
hearing opening statements from members, and it is now in order 
to yield to the ranking member of the subcommittee, Mr. Pallone 
of New Jersey, 5 minutes for an opening statement, please.

            OPENING STATEMENT OF FRANK PALLONE, JR.

    Mr. Pallone. Thank you, Mr. Chairman.
    Today's hearing provides a critical opportunity for 
committee members to better understand 42 CFR Part 2 and the 
legislative proposal to roll back the heightened protections it 
provides.
    As I noted at the subcommittee markup, we all agree that 
action must be taken to combat the opioid epidemic ravaging our 
country, but taking the wrong action because we are not 
spending the appropriate amount of time to understand the 
consequences of a proposal could have serious consequences of 
making things worse. And that is why I requested a separate 
hearing that just focused on Part 2 and any legislative 
proposal that would make changes to it. And, as you know, not 
only is this issue controversial, but it is complicated.
    So I thank the chairman for having this hearing, because I 
think it will help members hear firsthand why the substance use 
disorder patient advocacy community is united in their 
opposition to rolling back the protections of Part 2. This is 
the community that will bear the ultimate burden of this 
action, and, therefore, we should listen to their thoughts 
before making any changes that could potentially cause harm. 
And we will also hear more about why the substance use disorder 
provider community is split on this issue.
    Mr. Chairman, you know we are in the midst of the worst 
opioid epidemic in our country's history. While I appreciate 
the bill's sponsors' intention to help build a better 
healthcare system for the patient community, I do have concerns 
with the proposal before us. Confronting the opioid crisis 
requires identifying strategies that promote more people 
entering and remaining in treatment for opioid use disorder. 
This is critically important because major challenges exist to 
getting people with substance use disorders to enter treatment. 
In fact, SAMHSA's National Survey on Drug Use and Health found 
that only about 4 million people out of approximately 21 
million Americans in need of substance use disorder treatment 
received it in 2016, and that is only 19 percent.
    And I believe that any action that will potentially prevent 
people from seeking treatment for any substance use disorder, 
and particularly opioid use disorder, must be avoided. 
Unfortunately, the proposal before us I think risks doing just 
that--reducing the number of people willing to come forward and 
remain in treatment.
    Part 2 generally requires patient consent to share their 
substance abuse disorder medical records. That is because 
individuals might not seek or remain in treatment if they are 
worried about the real negative consequences that seeking 
treatment can have on their lives. It can mean the loss of a 
job, a home, or a child. It also could mean discrimination by 
doctors and insurers or, worse, arrest, prosecution, and 
incarceration.
    Disclosure of substance abuse disorder information has 
tangible consequences that are not the same as other medical 
conditions. You can't legally be fired for having cancer, you 
are not denied visitation to your child due to severe acne, and 
you are not incarcerated for having a heart attack.
    But ensuring strong privacy protections is critical to 
maintaining people's trust in the healthcare system and 
willingness to obtain needed health services, and these 
protections are especially important where very sensitive 
information is concerned.
    So I think we are at a critical moment. At this moment, I 
believe we should heed the advice of the congressional 
conferees that negotiated the confidentiality statute that 
created Part 2, and I am quoting. It said: ``The conferees wish 
to stress their conviction that the strictest adherence to 
confidentiality of substance use disorder patient records is 
absolutely essential to the success of all drug abuse 
prevention programs. Every patient and former patient must be 
assured that his or her right to privacy will be protected. 
Without that assurance, fear of public disclosure of drug abuse 
or of records that will attach for life will discourage 
thousands from seeking the treatment they must have if this 
tragic national problem is to be overcome.''
    Once again, we face a tragic national drug abuse problem, 
the scale of which our country has never seen. And I believe 
maintaining the heightened protections of Part 2 remain vital 
to ensuring all individuals with substance abuse disorder can 
seek treatment for their substance abuse disorder with 
confidence that their right to privacy will be protected, and 
to do otherwise at this time I just think is too great a risk.
    I yield the rest of my time to the gentlewoman from 
California, Ms. Matsui.
    [The prepared statement of Mr. Pallone follows:]

             Prepared statement of Hon. Frank Pallone, Jr.

    Thank you Mr. Chairman. Today's hearing provides a critical 
opportunity for Committee Members to better understand 42 CFR 
Part 2 and the legislative proposal to roll back the heightened 
protections it provides.
    As I noted at the Subcommittee markup, we all agree that 
action must be taken to combat the opioid epidemic ravaging our 
country; but taking the wrong action, because we are not 
spending the appropriate amount of time to understand the 
consequences of a proposal could have very serious consequences 
of making things worse. That's why I requested a separate 
hearing that just focused on Part 2 and any legislative 
proposal that would make changes to it. As you know, not only 
is this issue controversial, it is complicated.
    Ensuring adequate privacy protections is not easy. It 
requires balancing the needs of patients with regard to the 
privacy of their medical information with the needs of a 
coordinated health care system to best serve patients.
    I believe today's hearing will provide Members the 
opportunity to better understand this issue, and hopefully 
truly grasp the potential unintended consequences at risk to 
people's privacy. This includes the treatment of medical 
records under HIPAA's treatment, payment, and health care 
operations exceptions compared to Part 2, as well as the 
implications of such differences.
    This hearing will also help Members hear firsthand why the 
substance use disorder patient advocacy community is unified in 
their opposition to rolling back the protections of Part 2. 
This is the community that will bear the ultimate burden of 
this action, and therefore we should listen to their thoughts 
before making any changes that could potentially cause harm. We 
will also hear more about why the substance use disorder 
provider community is split on this issue.
    Mr. Chairman, we are in the midst of the worst opioid 
epidemic in our country's history. While I appreciate the bill 
sponsor's intentions to help build a better health care system 
for the patient community, I have serious concerns with the 
proposal before us. Confronting the opioid crisis requires 
identifying strategies that promote more people entering and 
remaining in treatment for opioid use disorder. This is 
critically important because major challenges exist to getting 
people with substance use disorders to enter treatment. In 
fact, SAMHSA's National Survey on Drug Use and Health found 
that only about 4 million people out of approximately 21 
million Americans in need of substance use disorder treatment 
received treatment in 2016. That's only 19 percent.
    I believe any action that will potentially prevent people 
from seeking treatment for any substance use disorder, and in 
particular opioid use disorder, must be avoided. Unfortunately, 
the proposal before us risks doing just that--reducing the 
number of people willing to come forward and remain in 
treatment.
    Part 2 generally requires patient consent to share their 
substance use disorder medical records. That is because 
individuals might not seek or remain in treatment if they are 
worried about the real negative consequences that seeking 
treatment can have on their lives. It can mean loss of a job, a 
home, or a child. But it also could mean discrimination by 
doctors and insurers or worse arrest, prosecution, and 
incarceration.
    Disclosure of substance use disorder information has 
tangible consequences that are not the same as other medical 
conditions. You cannot legally be fired for having cancer, you 
are not denied visitation to your child due to severe acne and 
you are not incarcerated for having a heart attack.
    Ensuring strong privacy protections is critical to 
maintaining peoples' trust in the health care system and 
willingness to obtain needed health services. These protections 
are especially important where very sensitive information is 
concerned.
    We are at a critical moment in history. And at this moment, 
I believe that we should heed the advice of the Congressional 
Conferees that negotiated the confidentiality statute that 
created Part 2:
    ``The conferees wish to stress their conviction that the 
strictest adherence to . . . [confidentiality of substance use 
disorder patient records] is absolutely essential to the 
success of all drug abuse prevention programs. Every patient 
and former patient must be assured that his [or her] right to 
privacy will be protected. Without that assurance, fear of 
public disclosure of drug abuse or of records that will attach 
for life will discourage thousands from seeking the treatment 
they must have if this tragic national problem is to be 
overcome.''
    We once again face a tragic national drug abuse problem--
the scale of which our country has never seen--and I believe 
maintaining the heightened protections of Part 2 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. Thank you, I yield back.

    Ms. Matsui. Thank you, Ranking Member Pallone, and thank 
you, Mr. Chairman, for holding this hearing today. This is a 
very important complex issue relating to the opioid epidemic. I 
feel strongly that we should take action in this space. 
Patients that are currently receiving treatment may not be 
getting the best care if their provider does not have all the 
information necessary.
    However, many challenges remain, only some of which might 
be solved by this bill. Providers still don't always have 
electronic health records, and even when they do, information 
is not always shared across providers. We cannot fully 
coordinate care if substance abuse is not a part of your 
medical history.
    However, we are walking a fine line. As much as we need to 
reduce stigma and move toward integrated care, we still face 
technological, medical, and social barriers. Most of all, we do 
not want to unintentionally harm patients who may still be 
discriminated against for their addiction.
    I look forward to the discussion today, and I thank the 
witnesses for their testimony.
    Thank you, and I yield back.
    Mr. Burgess. And the gentleman yields back. The chair 
thanks the gentleman.
    This concludes the member opening statements. The chair 
would like to remind members, pursuant to committee rules, all 
members' opening statements will be made part of the record.
    Testifying for our first panel is Congressman Earl 
Blumenauer.
    Thank you, Mr. Blumenauer, for being with us today and 
taking your time to testify before the subcommittee. We look 
forward to what you have to share with us.
    Just as a housekeeping detail, as is the general custom 
with a Member testifying, we will not do questions, but we will 
go directly to our second panel of witnesses.
    Congressman Blumenauer, you are now recognized, 5 minutes, 
to summarize your opening statement.

  STATEMENT OF THE HON. EARL BLUMENAUER, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF OREGON

    Mr. Blumenauer. Thank you, Mr. Chairman, for your courtesy, 
and I appreciate the opportunity to share some observations 
with you to be able to discuss how better to provide high-
quality coordinated care for patients with substance use 
disorders.
    And I heard my two colleagues here, and I agree, but we are 
looking here--I will put it slightly different. We have an 
antiquated law that prevents lifesaving medical care for 
patients in recovery for substance use disorders. Originally 
designed to protect the privacy of individuals in addiction 
treatment, this decades-old barrier now creates an impediment 
to the implementation of integrated care.
    The Drug Abuse Prevention, Treatment, and Rehabilitation 
Act of 1972 currently governs how doctors and healthcare 
professionals share alcohol or substance use disorder records. 
Under this law, which predates HIPAA of 1996, patient medical 
records from addiction treatment facilities are segregated from 
the patient's medical records. And this can create a life-
threatening firewall that prevents medical doctors from knowing 
their patients' full medical history, which could include 
treatment for substance use disorders.
    The rules that govern this firewall, known as 42 CFR Part 
2, or simply Part 2, are more restrictive than HIPAA. It 
supersedes HIPAA and can only be breached in an emergency or 
with express written consent of the patient. This consent can 
often be impossible or difficult to maintain, and in those 
instances, the care itself cannot be fully integrated. Failure 
to modernize Part 2 has weakened our nation's ability to 
respond to the ongoing opioid crisis that is contributing to a 
record number of drug overdose deaths in 2017 and are 
continuing.
    Our nation's healthcare delivery system has changed and 
innovated over the last 45 years. As providers shift towards 
new coordinated models of care, they must rely on shared 
medical information to improve patient health.
    Regulations in Part 2 restrict the providers' ability to 
access critical substance treatment information, which can 
result in poor and in some cases tragic outcomes. And I believe 
the subcommittee has heard some really jarring testimony to 
this effect. Doctors can't treat a whole patient with half a 
medical record. And patients have a right to the best medical 
care available. Along with Representative Mullin, we have been 
pleased to author this bipartisan Overdose Prevention Act to 
prevent tragedies such as the committee has heard.
    The legislation would treat medical records generated at a 
substance use treatment facility that relate to treatment, 
payment, or healthcare operations in exactly the same manner as 
all other medical records, removing the stigma that has for so 
long segregated those records from the rest of the healthcare 
system.
    At the current time, persons with substance use disorders 
are the only subset of the healthcare patients whose records 
are treated differently and, as a result, may not receive the 
coordinated care they need.
    Now, there is stigma associated with mental health and HIV/
AIDS, but both mental health and HIV/AIDS fall under the 
protections of the HIPAA privacy law. Care is improving for 
both of those populations, thanks to increased access to public 
health data and open lines of communication that reduce 
unnecessary discrimination.
    For Americans who are in recovery, our legislation 
maintains and strengthens Part 2 protections, to prevent 
disclosure of information. For example, it is currently illegal 
to share individuals' substance treatment record for an 
employer, law enforcement, or landlord. That wouldn't change 
under this legislation. Indeed, we would strengthen the 
penalties for unauthorized disclosure to make it more secure. 
As the healthcare system moves forward, more robust, integrated 
care models, every member of a patient's treatment team needs 
to understand the patient's full medical history, including 
substance abuse disorder. Current Part 2 regulations stand as a 
hindrance to the whole person care, and I think they must be 
changed to ensure all patients, regardless of diagnosis, have 
access to safe, effective, high-quality treatment and care.
    I deeply appreciate the opportunity to share some 
observations with you and look forward to your discussions in 
this area to be able to give people the big picture. Thank you 
very much.
    [The prepared statement of Mr. Blumenauer follows:]

[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Burgess. Mr. Blumenauer, thank you for providing your 
testimony to the subcommittee today. It is a very valuable part 
of our insight into solving this problem.
    Mr. Walden. Mr. Chairman, before my colleague from Oregon 
departs the table----
    Mr. Burgess. The gentleman is recognized.
    Mr. Walden [continuing]. I would point out that, in 1972, 
he was winning his first election to the statehouse at the age 
of either 23 or 24, depending upon when this was written into 
law. So not that it has been a long time since 1972, but he has 
had a very distinguished career ever since. On the city 
council, my father and he served together in the State 
legislature. Yes, he does go back that far. And then here in 
the Congress. So we appreciate him being here and sharing this.
    Mr. Blumenauer. And his father was the real legislator.
    Mr. Walden. Mr. Chairman, is this where I move to table the 
bill?
    Mr. Green. Does the chairman yield? Mr. Chairman, I was 
also elected in 1972. Are you telling me we are old?
    Mr. Walden. I would never--no. I am saying the law that was 
started in 1972 is old.
    Mr. Burgess. The chair thanks the historical perspective 
that all have provided today.
    Mr. Blumenauer, again, thank you for sharing with us.
    And we will transition into our second panel. And as we do 
that, I want to thank all of our witnesses for being here 
today, and join us at the witness table. Each witness is going 
to have the opportunity to give an opening statement, followed 
by questions from members.
    Do we have our name placards at the ready?
    So, as Zach is placing the names, today we are going to 
hear from Mr. Dustin McKee, director of policy, the National 
Alliance on Mental Illness, from Ohio; Ms. Patty McCarthy 
Metcalf, executive director, Faces and Voices of Recovery; Mr. 
Jeremiah Gardner, manager of public affairs and advocacy, 
Hazelden Betty Ford Foundation; Dr. Westley Clark, the dean's 
executive professor, Public Health Program, Santa Clara 
University; and Mr. Gerald DeLoss, officer, Greensfelder, 
Hemker and Gale, Public Corporation.
    We appreciate each of you being here today. And, Mr. McKee, 
you are now recognized for 5 minutes for an opening statement, 
please.

 STATEMENTS OF DUSTIN MCKEE, DIRECTOR OF POLICY, THE NATIONAL 
  ALLIANCE ON MENTAL ILLNESS OF OHIO; PATTY MCCARTHY METCALF, 
  EXECUTIVE DIRECTOR, FACES AND VOICES OF RECOVERY; JEREMIAH 
GARDNER, MANAGER OF PUBLIC AFFAIRS AND ADVOCACY, HAZELDEN BETTY 
  FORD FOUNDATION; H. WESTLEY CLARK, M.D., J.D., M.P.H., THE 
DEAN'S EXECUTIVE PROFESSOR, PUBLIC HEALTH PROGRAM, SANTA CLARA 
UNIVERSITY; AND GERALD (JUD) E. DELOSS, OFFICER, GREENSFELDER, 
                     HEMKER AND GALE, P.C.

                   STATEMENT OF DUSTIN MCKEE

    Mr. McKee. Thank you, Mr. Chairman.
    Chairman Burgess, Vice Chair Guthrie, Ranking Member Green, 
and members of the Energy and Commerce Subcommittee on Health, 
thanks for this opportunity to testify before you today on H.R. 
3545, the Overdose Prevention and Safety Act. As you all well 
know, our nation is in the midst of a public health crisis.
    Between 2014 and 2016, in my home State of Ohio, 10,383 
people died from an opiate-related overdose. One of those 
people that died during that time was my big brother, Brandon 
J. McKee. He was 36. He left behind three sons, 4, 11, and 16. 
Mr. Chairman, Brandon's death was preventable. However, the 
antiquated provisions of 42 CFR Part 2 prevented his medical 
professionals that were prescribing him high doses of opiate-
based pain medications with multiple refills from knowing that 
they were treating a high-risk patient with an ongoing history 
of substance abuse treatment and relapse.
    But before I start describing the events leading to his 
death, I want to tell you a little bit about Brandon. Brandon 
struggled for most of his life with addiction disorder, but in 
spite of it, he found success early. My big brother was the 
best salesman you will ever meet. This guy could sell a double 
bacon cheeseburger to a vegan. He was a talented salesman that 
made six figures by the time he was 20 years old selling cars 
in Mansfield, Ohio, as a sales manager.
    But despite two courses of residential treatment and 
periodic outpatient treatment for substance use disorder, his 
substance use led to several job losses, multiple DUIs, lots of 
family strife, and an eventual divorce. After that divorce, he 
moved into my mom's basement. She was kind enough to let him be 
there to try and get sober.
    One night, he decided to go out and he got into a terrible 
car crash that crushed a few vertebrae in his spine. He was 
transferred up to Cleveland Metro Hospital. The orthopedist had 
no way of knowing he was an addict. So, after the surgery, he 
was prescribed high doses of opiate-based pain medication with 
multiple refills. Four months later, interestingly enough, he 
broke his back again while riding his bike and getting into a 
wreck. Again, he went to that same surgeon, and, again, he was 
prescribed high doses of opiate-based painkillers with multiple 
refills. He didn't sign a 42 CFR waiver. He was an addict. He 
was about ready to get the holy grail. Those drugs made him 
feel perfect.
    We didn't even know that he was on narcotics until--well, I 
was the last one to speak with him 3 days before his death. He 
had burned all his bridges because of the secrets and lies 
associated with his addiction disorder. He called me that day 
and admitted that it was more than just the alcohol and that he 
was taking pills. And I said I was proud of him for telling me 
about it. Ironically, his phone battery was drained that day, 
and his phone cut out before the conversation was over. His 
last words to me were, ``I am going to go to that NA meeting 
tonight, I promise, brother.'' Three days later, he died of a 
heroin overdose. He was found alone in his apartment curled up 
on the floor in the fetal position. It was May 10, 2014.
    Mr. Chairman, Brandon's story demonstrates that 42 CFR Part 
2 is a significant barrier to integrating care for behavioral 
health, medical/surgical care, and aftercare. It is also a 
major patient safety issue. We at the National Alliance on 
Mental Illness know that siloed treatment for mental illness 
and addiction is ineffective, leads to negative outcomes. This 
is common sense.
    I would further emphasize that H.R. 3545 takes a very 
narrow targeted approach that simply aligns 42 CFR Part 2 with 
HIPAA for the purposes of sharing information only for 
treatment, payment, and healthcare operations. There is no risk 
that the records will be shared with outside parties, like 
landlords, employers, law enforcement, or exposing folks to 
civil litigation.
    These are commonsense policy changes. You can make these 
changes. The lives of your constituents may just depend on it.
    Thank you for this opportunity to testify before you today. 
I would be happy to answer any questions.
    [The prepared statement of Mr. McKee follows:]

[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Burgess. Mr. McKee, thank you for your testimony.
    Ms. Metcalf, you are recognized for 5 minutes, please.

              STATEMENT OF PATTY MCCARTHY METCALF

    Ms. Metcalf. Good afternoon. And, first, I would like to 
thank the committee for hosting this important hearing and for 
inviting me to testify. My written and oral testimony are the 
result of my experience as a person in substance use disorder 
recovery, as well as my professional experience as the 
executive director of Faces and Voices of Recovery.
    I am a woman in long-term recovery from alcohol and drug 
addiction. For me, that means I haven't used alcohol or drugs 
in over 28 years. And that recovery has allowed me to give back 
to my community, earn college degrees, own a home, raise a 
family, pay taxes, establish a career, and become a leading 
advocate for the recovery community.
    As an organized voice protecting the rights of individuals 
with substance use disorders, Faces and Voices of Recovery is 
adamantly opposed to dismantling of our critically important 42 
CFR Part 2 confidentiality protections. We do not want our 
highly sensitive personal information shared for the purposes 
of treatment, payment, healthcare operations, or for any other 
purpose beyond the current rule without our express written 
consent.
    We agree with the Congress who enacted Part 2 in the 1970s 
that weakening privacy regulations will discourage individuals 
who need treatment from seeking it. The dismantling of Part 2 
is the antithesis of the principle of patient-centered, 
integrated care and is largely being pursued by coalitions and 
entities who hold their own business interests ahead of the 
rights of the interests of our community. These protections are 
as critical now as they were 40 years ago and must be 
maintained to ensure that individuals and families will seek 
help.
    We believe that the interaction between a treatment 
provider and the client, when discussing specific consents and 
disclosures, strengthens the therapeutic relationship and 
builds trust. Patients feel secure enough to know where their 
personal health information is going and for what purpose. Most 
often, the treatment provider encourages their clients to 
provide a written consent, to share information with their 
primary care physician, but if the client is reluctant to do so 
for whatever reason, they have an opportunity to weigh the 
benefits and discuss the options.
    We wouldn't be here today discussing Part 2 if it weren't 
for the fact that we are in the midst of an opioid epidemic. 
But I want to remind you that the Federal confidentiality 
regulations are intended to protect the privacy for all 
individuals with all substance use conditions, not just those 
with opioid use disorders.
    There are an estimated 16 million people like me in the 
United States that have an alcohol use disorder. And research 
has repeatedly shown that people with alcohol use disorders 
experience stigmatization by the public as well as from health 
professionals more severely than people with mental disorders. 
This perceived stigma is shown to reduce the probability of 
using healthcare services and thereby contributes to a 
decreased likelihood of seeking treatment.
    Research also indicates that worries about privacy keep 
people from seeking treatment. Making these changes to minimize 
our privacy protections will have long-lasting effects for a 
wide range of individuals and family members. The potential for 
negative consequences of stigma and discrimination with regard 
to employment and education is real for millions of Americans, 
even after years of sustained recovery from alcohol and drug 
addiction. And unlike most other medical illnesses, substance 
use disorders often have criminal and civil, legal 
consequences, and patients are vulnerable to arrest, 
prosecution, and incarceration.
    Patients may be hesitant to reveal they have been 
discriminated against, because they would have to disclose the 
use of illegal drugs as well as the activities that are 
associated with the use of illegal drugs. The vast majority of 
persons who will have this happen to them will lack the 
resources to determine who used their information in an 
improper way. Even if they did know this, in most cases, they 
would not take action for the very fact that trying to assert 
their rights would acknowledge drug use and addiction in a way 
that would open them up to prosecution and discrimination. Part 
2 provides safeguards for patients against potentially 
disastrous results of unauthorized disclosure.
    In conclusion, beyond the significant harm that eliminating 
Part 2 would do to our communities, it is entirely unnecessary. 
There is far too much at stake here for those of us depending 
on these protections in order that we may heal and realize our 
full potential as productive citizens of this great nation. 
Many of us have made it clear that we would not have gone to 
substance use disorder treatment or accepted services if we 
thought our information would be shared with other entities 
without our permission or knowledge. We would not have put our 
careers, reputations, our families at risk of stigma and 
discrimination if we were not assured that our information 
about our substance use disorder was safe and would only be 
shared with our consent. As a person in long-term recovery, a 
parent, and on behalf of the recovery community, I look forward 
to working with members of the committee to protect patient 
privacy.
    And thank you for the opportunity to testify and address 
such an important issue to our community.
    [The prepared statement of Ms. Metcalf follows:]

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    Mr. Burgess. Thank you, Ms. Metcalf.
    Mr. Gardner, you are recognized for 5 minutes, please.

                 STATEMENT OF JEREMIAH GARDNER

    Mr. Gardner. Mr. Chairman, thank you for inviting me. I am 
grateful to you and the subcommittee members for your 
leadership in addressing opioids and addiction and for this 
opportunity to testify in support of H.R. 3545.
    My name is Jeremiah Gardner, and I am a person in long-term 
recovery from substance use disorder. I am also a recovery 
advocate with a master's degree in addiction studies and a 
counseling license. In addition, I work as a communications 
professional for the Hazelden Betty Ford Foundation, a 
nonprofit that has been advocating for patients and helping 
them overcome addiction for decades.
    I believe all of us here today can agree about the need for 
more coordinated and integrated care, less discrimination 
against those with substance use disorder, and appropriate 
patient privacy. We all want to help patients, not harm them. 
H.R. 3545 is not a question of privacy versus no privacy or 
coordination versus no coordination or discrimination versus no 
discrimination, providers versus patients. The very specific 
question, as the chairman noted, is, does HIPAA provide 
sufficient enough privacy protection to warrant removing the 
Part 2 barriers that sometimes get in the way of more 
efficient, coordinated care.
    And as you weigh that choice, I would like to tell you 
about my mom, who is another illustration of why this topic is 
so important. At age 59, my mother misused fentanyl patches, 
Vicodin, and anxiety medications, and died just a couple of 
rooms away from her husband and 13-year-old grandson.
    She had started taking prescribed opioids 20-some years 
earlier for pain. Eventually, she was on 400 milligrams of 
morphine a day, which over time led to other ailments, 
deteriorating mental health, and additional medications, not to 
mention more doctors. She had lots of them, and lots of 
medications.
    But before her long journey with opioids began, she was 
treated for alcohol problems at a Part 2 facility. It was a 
significant fact in her health history that, as far as I can 
tell, escaped the attention of her later doctors and failed to 
inform her healthcare moving forward.
    Two decades later, at the end, my mom suffered from a 
complex combination of opioid use disorder, chronic pain, acute 
pain due to knee surgery, depression, anxiety, arthritis, type 
2 diabetes, and other physical conditions. She also had an 
assortment of social stresses and, because she relied so much 
on pills for so long, a deficit of healthy coping mechanisms. 
Her pain was, indeed, profound, manifesting itself like 
addiction does: physically, mentally, emotionally, socially, 
and spiritually.
    What my mom needed but never got was a good year or more of 
integrated, coordinated care, and checkups surrounded by 
support. She needed her multiple care providers to have the 
full picture of her health and to work together. Instead, they 
kept prescribing deadly amounts and combinations of drugs to 
somebody with a substance use disorder. My mom got subpar care.
    Could she have done more to actively coordinate care 
herself? Yes. But as a professional in the field and someone 
with lived experience, I can tell you that that is a tall order 
for someone with a severe substance use disorder. Maybe she was 
too embarrassed or ashamed to acknowledge her condition because 
of the public stigma. Maybe she didn't understand she was at 
greater risk, or maybe she did and was not inclined to 
volunteer information that might prevent her from getting pills 
for her pain or her anxiety.
    She eventually came to know opioids as a relentless monkey 
on her back, but she also saw them as a solution. And that 
drive to continue using despite problems reflects the very 
nature of addiction. My mom needed help recognizing that her 
constellation of issues tied together, and that substance use 
disorder was in many ways at the center of it.
    My point in sharing is simply that the health of people 
like my mom can be very complex. Coordinated care is critical 
and too often absent, and timely relevant information sharing 
is important.
    This bill isn't just about IT or workflows or convenience 
or efficiency or stigma or cost. It is about knocking down any 
barriers we can to help ensure optimal care. It is about taking 
the next step toward parity and bringing the full weight of 
healthcare to bear against this public health problem. Most of 
all, it is about people, real people with families like my mom.
    There is some fear this bill will discourage help seeking. 
I certainly don't speak for all patients or family members, but 
I can tell you privacy laws were not a factor in my own help 
seeking or my mom's contemplations. And the topic, frankly, is 
rarely broached by the thousands who call the Hazelden Betty 
Ford Foundation for help each year. Most want to know, can you 
help, and how can I pay for this?
    I really believe this bill addresses those priorities that 
patients and their families care about most. I also believe 
HIPAA is a sufficient and enforceable privacy standard, that 
discrimination can and must be prosecuted vigorously, and that 
this is an essential piece of the Federal opioid response and 
the paradigm shift that began with the 2008 parity law.
    Thank you for the opportunity to share. I look forward to 
answering your questions.
    [The prepared statement of Mr. Gardner follows:]

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    Mr. Burgess. Thank you, Mr. Gardner.
    Dr. Clark, you are recognized for 5 minutes, please.

       STATEMENT OF H. WESTLEY CLARK, M.D., J.D., M.P.H.

    Dr. Clark. Thank you, Mr. Chairman, Mr. Green, and members 
who are assembled. Thank you for the opportunity to present to 
you here today.
    I am here as a physician, addiction medicine specialist, 
and as a college professor. I am here to advocate for 
maintaining the integrity of 42 U.S.C. 290dd-2 and for keeping 
those Federal regulations that protect individuals with 
substance use disorders. Do not discourage them from seeking 
treatment by stripping away their current right to consent to 
the release of their personal substance use disorder histories.
    There are two contemporary phenomenon that are relevant 
here: one, the Facebook Cambridge Analytica issue; and, two, 
the NIH All of Us longitudinal research project. In the case of 
the Facebook Cambridge Analytica issue, it was clear that the 
general discourse about the misuse of information, that privacy 
and confidentiality were important to people and the disclosure 
of their private information without their consent was a 
violation. That the information was subsequently used for 
predictive analytics for the purpose of influencing those whose 
information had been compromised shows the potential for abuse. 
This was not a case of data security, but a case of breach of 
confidentiality and apparent invasion of privacy.
    Alternatively, the NIH study will include all data 
available in the participants' electronic health records, 
including demographics, visits, diagnosis, procedures, 
medications and laboratory visits. Pertinent information can 
include data about mental health, substance use, or HIV status.
    What is interesting about the NIH All of Us study and 
relevant to this hearing is that participants will be asked to 
consent to release information from their electronic health 
records. The All of Us study invokes the idea of the 
comprehensive health record heralded by some EHR vendors, who 
seek a new generation of electronic information about people, 
information that includes all sorts of medical and nonmedical 
information. Thus, the medical record becomes a comprehensive 
dossier on the individual.
    The actual benefit to a patient of integrating all that is 
known about an individual using the health record as the portal 
has yet to be determined. Privacy, confidentiality, and consent 
are important to Americans. If the two vignettes that I have 
used to introduce my testimony can be understood in the context 
of the current discussion, then you, as Members of Congress, 
will understand the importance of maintaining the projections 
of 42 U.S.C. 290dd-2 and 42 CFR Part 2 to a population that is 
more vulnerable than those on Facebook or those who agree to 
participate in the All of Us study.
    While the issue of opioid misuse is of major importance, we 
should keep in mind that 42 CFR Part 2 does not just apply to 
opioids. The National Survey on Drug Use and Health reveals 
that 65 million Americans admit to binge drinking in the past 
month and 24 million Americans admit to being past month users 
of marijuana.
    The critical question today is, how do we get the 28.6 
million Americans who are current illegal drug users and the 65 
million Americans who are binge drinkers to discuss their 
substance use with the medical community? We won't do it by 
compromising their privacy.
    It is also argued that substance use is like the flu, 
diabetes, hypertension, or HIV, and, therefore, should be 
treated like those conditions with regard to disclosure. The 
reality is that most substances of misuse are illegal and that 
disclosure of such information can give rise to harm to the 
individual affected. These harms include loss of employment, 
loss of housing, loss of child custody, the loss of benefits, 
stigma and discrimination, the loss of privacy, shame, and the 
loss of economy.
    The case is often made that healthcare delivery systems 
need to know about the substance use history of a patient. You 
don't hear why providers can't simply ask patients themselves 
about their substance use histories. You hear it is too 
confusing clinicians know about 42 CFR Part 2 and how to apply 
the rule. Yet these same clinicians and healthcare systems 
spend quite a bit of time learning about and executing 
reimbursement rules, administrative rules, quality standard 
rules, and all the rules that are necessary to get paid for 
services delivered to the very people whose agency and dignity 
are now deemed too inconvenient to respect.
    You may also hear that people lie about their substance 
use, implying that they cannot be trusted. However, since 
behavioral care is the dominant form of substance use 
treatment, trust is the cornerstone with behavioral treatment. 
We should be promoting a patient-provider cooperative 
relationship instead of encouraging an adversarial one.
    The healthcare operations exception found in HIPAA is a 
loophole in confidentiality that is so large you can drive a 
Mack Truck through. Neither provider not regulators will be 
able to protect those with substance use disorders. The only 
choice left to those who are vulnerable is not to seek 
treatment. Remember, 90 percent of those who currently need 
treatment do not seek treatment. We should be focused on 
reducing the ratio of those who need treatment versus those who 
seek treatment from nine to one, to one to nine.
    Therefore, I ask you, please do not weaken 42 U.S.C. 290dd-
2, and as a result, I ask you to look closely at H.R. 3545. It 
is not the panacea that it is being marketed as being. Thank 
you.
    [The prepared statement of Dr. Clark follows:]

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    Mr. Burgess. Dr. Clark, thank you for your testimony.
    Mr. DeLoss, you are recognized for 5 minutes please.

              STATEMENT OF GERALD (JUD) E. DELOSS

    Mr. DeLoss. Thank you. My name is Jud DeLoss. I am an 
attorney with Greensfelder, Hemker and Gale in Chicago, 
Illinois, and I practice in behavioral health law as well as 
health information privacy and confidentiality.
    I represent several behavior healthcare providers that are 
governed by 42 CFR Part 2 as well as others that are impacted 
by those provisions and overly restrictive provisions, 
including the county of Lake County in Illinois, Nicasa, North 
Central Behavior Health Systems, Stepping Stones Treatment 
Center, and TASC. Each of these are large and small providers 
that have had to come to bear and deal with these provisions 
and these restrictions.
    I am here today on behalf of Netsmart Technologies, a 
technology partner with the behavioral healthcare space, and I 
am here today to discuss the protections that are provided 
under HIPAA as well as under 42 CFR Part 2 and the legislation 
that we are discussing, as well as those protections that would 
be not only retained but enhanced by H.R. 3545.
    At the outset, I wanted to describe those limitations that 
would remain in place because of H.R. 3545, as amended. As 
mentioned earlier, the only change that the bill would provide 
in terms of disclosures without consent would be with respect 
to treatment, payment, and healthcare operations. We are not 
talking about disclosures for legal proceedings. We are not 
talking about disclosures to law enforcement. We are not 
talking about disclosures to employers, landlords, marketers, 
et cetera. We are talking about those limited purposes that are 
the primary types of opportunities and activities that all 
sorts of healthcare providers engage in.
    In addition, and more specifically to address some of the 
concerns that were raised about operations and the extent and 
scope of exchanges of information for healthcare operations 
under HIPAA, the disclosures allowed under the bill would only 
be allowed to other covered entities.
    Covered entities is a HIPAA-defined term. It includes only 
healthcare providers, health plans, and healthcare 
clearinghouses, those entities that assist in the reimbursement 
process. Only those three entities would be allowed to receive 
Part 2 information under the bill. It would not be fair to say 
that this information could be shared with third parties. It 
would not be fair to say that it could even be shared with 
business associates, strictly reading the terms of the bill. So 
we would not open up the exchange of information to third 
parties that have no business. These are parties that need this 
information in order to carry out payment, treatment, and 
healthcare operations.
    The bill itself provides substantial protections, in terms 
of the disclosures for civil, criminal, and administrative 
proceedings. The bill actually enhances those protections that 
42 CFR Part 2 previously had in place. So there are increased 
and heightened types of protections that are available.
    I did in my written comments set forth a lengthy review of 
the protections that are available under HIPAA, those in terms 
of the protections, in terms of legal proceedings, employers, 
also the impact of the Americans with Disabilities Act if any 
of this information should happen to get into the wrong hands. 
SUD is a disability under the ADA and is protected as such, as 
set forth in my written comments. Landlords and housing 
agencies would also be governed by HIPAA as well as the ADA. 
The law enforcement and legal proceedings exceptions under 
HIPAA are very narrow and very stringently enforced, primarily 
requiring a court order or patient consent in order for the 
information to be shared for those purposes.
    One of the areas that I did want to address is the 
inability under the current Part 2 regulations to allow for a 
patient to make a choice in terms of sharing their information 
for treatment, payment, or healthcare operations, as defined 
under this law as well as HIPAA.
    In addition, I think it is important to note that if a Part 
2 program does not want to share information, this bill and 
HIPAA, more importantly, would not mandate a disclosure without 
consent. The SUD treatment program has the opportunity to 
impose higher or more stringent protections against disclosure, 
not those simply set forth under HIPAA. So there is a choice 
not only for patients but also for programs or others that 
might be concerned about disclosure.
    To summarize the impact of the bill, a disclosure for 
treatment, payment, or healthcare operations can only be made 
to a covered entity. The covered entity, a healthcare provider, 
a health plan, or a healthcare clearinghouse--would then be 
bound by these regulations or this law not to disclose that 
information to anyone other than another covered entity down 
the line.
    So, in conclusion, I wanted to correct some of the 
misunderstandings with respect to HIPAA, misunderstandings with 
respect to the scope and impact of this law, and point out that 
HIPAA itself over the history of its enforcement has resulted 
in millions of dollars in fines and penalties, a comprehensive 
enforcement mechanism, where 42 CFR Part 2 has not. Thank you 
for your time.
    [The prepared statement of Mr. DeLoss follows:]

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    Mr. Burgess. Thank you, Mr. DeLoss. And I want to thank all 
of our witnesses for testifying before us today.
    And we are going to move into the question portion of the 
hearing. I am going to begin that portion by yielding my time 
to the gentleman from Oklahoma, Mr. Mullin, 5 minutes for your 
questions.
    Mr. Mullin. Thank you, Mr. Chairman.
    And thank you for all of our witnesses that are here today.
    Since I only have 5 minutes, I am going to get right into 
it.
    Dr. Clark, are all substance disorder providers subject to 
42 CFR Part 2?
    Dr. Clark. If they are federally assisted.
    Mr. Mullin. The answer is, are they all subject to it?
    Dr. Clark. Only if they are federally assisted.
    Mr. Mullin. So the answer to that is no. And they are not 
all Federal assistance, because the VA doesn't fall underneath 
Part 2. The VA doesn't fall underneath it, and they are Federal 
assistance.
    Dr. Clark. The VA has its own 38 CFR.
    Mr. Mullin. The question was, do all of them fall 
underneath 42 CFR?
    Dr. Clark. No.
    Mr. Mullin. So is there evidence that patients that don't 
fall underneath it, has that been abused?
    Dr. Clark. Well, you invoked the VA. I used to work for the 
VA, spent 14 years----
    Mr. Mullin. Sir, I said, is there evidence that people that 
do not fall underneath 42 CFR Part 2, is there evidence that 
their medical records are being abused and they are being 
discriminated against?
    Dr. Clark. I couldn't say that there is.
    Mr. Mullin. Because it is no.
    Part 2, how many times has it been tried, violators? People 
that violated Part 2, how many times has it been tried?
    Dr. Clark. It is not a heavily litigated area.
    Mr. Mullin. Heavily. It has never been. It has never been.
    Dr. Clark. It has been litigated, sir.
    Mr. Mullin. No, it is exactly zero. I have the information 
right here. And I know that you can give your opinion, but we 
are dealing with facts here.
    Dr. Clark. OK, I am a lawyer also, sir. And so from 1970--
--
    Mr. Mullin. No, no, hang on, it is my time. You said a lot 
in your 5 minutes. I am just pointing out holes in it.
    Now, underneath HIPAA, how many times has it been tried? 
173,426 times since 2003. Because Part 2 is unenforceable. They 
can't comply with it. It is only a $50 penalty.
    You start talking about discrimination. In your testimony, 
you said that the harms to which a person who admits to 
substance use may suffer includes the loss of employment, the 
loss of housing, the loss of child custody, the loss of 
benefits, stigma, discrimination, the loss of privacy, and the 
loss of anonymity.
    How would that actually work? How would you do this legally 
underneath the system that is there? Is that just an assumption 
that you are making? Because there is no legal way to actually 
do that. There are laws already that protect the individual 
from that. Is that not true?
    Dr. Clark. No, that is not true for----
    Mr. Mullin. Oh, there isn't? Well, you are an attorney, so 
explain that to me then.
    Dr. Clark. OK. If I am an active substance user, the ADA 
does not protect me. The Americans with Disabilities Act does 
not protect an active substance user who is using illegal 
substances.
    Mr. Mullin. So there are not any laws that protect people 
from being discriminated against? Because as a person that also 
has several property companies, I can't use that information to 
deny someone from housing. As an employer, I can't use that to 
deny someone for employment, because it would be 
discriminating. So you are making an assumption here that is 
actually not accurate.
    Now, you also said in your testimony that you are comparing 
my bill to the Cambridge Analytica/Facebook issue. How is 
adding antidiscrimination language and extra protection for 
patient information comparable to the Facebook data scrubbing?
    Dr. Clark. The issue is data scrubbing. Just as you said, 
the healthcare----
    Mr. Mullin. I am not talking about data scrubbing here.
    Dr. Clark. We are talking about data scrubbing.
    Mr. Mullin. Who is scrubbing it?
    Dr. Clark. When you are talking about electronic health 
records, you are talking about predictive analytics, and you 
are talking about data scrubbing.
    Mr. Mullin. Yes. But we already show that the only people 
this covers is essentially Medicare and Medicaid. And when we 
get into the situation that private payers in VA, that they are 
not being discriminated against, why is this such a big issue 
now?
    Because you are making a lot of assumptions. And, sir, I 
know that you are able to make the assumptions. But we are also 
dealing with people's lives.
    Is there anybody in here that doesn't get touched by--this 
has touched me three different times, and I take it very 
personal. And when people come here and they want to give their 
opinion, and it is not based on facts, it really bothers me. I 
am sure you are a very smart individual. Sir, I am sure you are 
a very smart individual, but you are coming in here, and you 
are just giving your opinion.
    Dr. Clark. Well, you wanted to know about, for instance, 
unemployment. The ADA does not apply to active substance users. 
That is a fact. That is not an opinion. So I can't help you 
with that.
    And, in fact, there are rules historically for housing. HUD 
used to have, and still does have, rules that allow you to 
discriminate against people who----
    Mr. Mullin. What are those rules? What are those rules?
    And, besides, by the way, you just mentioned another 
Federal agency. And this is about Federal protection for those 
on Medicare and Medicaid. We are talking about the private 
sector, because that is what you are making comparisons to.
    And, sir, I am very serious about trying to protect 
people's lives here. And I know you are too. But we got to make 
sure that we are dealing on the same page. And while I respect 
your ability to give your opinion, I completely disrespect your 
testimony because it is based on opinion, not facts.
    With that, I yield back.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    The chair recognizes the gentleman, the ranking member of 
the subcommittee, 5 minutes for questions, please.
    Mr. Green. Thank you, Mr. Chairman.
    I want to thank our witnesses for being here, because this 
is something that is really important because we have chemical 
addictions so rampant that we are changing law that provides 
more protection for someone chemically instead of just a mental 
or anything else.
    And, Dr. Clark, you have read the language in the bill. Is 
there any way that. as a lawyer, you could suggest other 
language than what is in the bill that would have some 
protection there that we still do? Because a number of us have 
concerns about this legislation. But I also know, under HIPAA, 
this is much stronger than anything HIPAA has, the bill does.
    Is there anything you would suggest that would feel more 
comfortable to both you but also to Ms. Metcalf? Because I 
understand, we all have relatives who really don't want to tell 
us what their issues are. And they have some right to privacy 
no matter what they have.
    Dr. Clark. Well, the first thing, as a physician, if your 
patient doesn't trust you, they won't disclose information to 
you. That is what gets lost in this.
    We know that people with mild to moderate conditions that 
lead to severe conditions don't talk about their substance use. 
So, if you want to save lives, you do it upstream. You don't 
wait until the problem is so severe that it is actually quite 
transparent to everybody in the room. And that is what actually 
happens. People hide their substance use, and there is no 
record of it.
    All the stories that you hear, how horrible they are and 
how tragic they are, the stories are that the people do not 
feel comfortable disclosing what is going on. So 90 percent of 
the people who meet criteria for an SUD don't discuss that with 
the healthcare delivery system.
    Now, the question is, is there any way to address this? The 
healthcare operations component of HIPAA, as I said in my 5 
minutes, it is so broad that it gives rise to--when you start 
explaining that to people, if you can explain it to them 
clearly, they will understand that they really have no privacy, 
and so they will keep their mouths shut.
    And by the time you are aware that their problems are so 
severe that they need intervention, it will become transparent. 
Your committee has dealt with physicians who have misused 
prescribing. We now know we have enough data of using 
prescription drug monitoring programs and other strategies that 
we can track what is happening with patients. So it won't be 
those people for whom prescriptions are written, because now we 
can track those. We can enhance electronic health records.
    There are models being proposed. The gentleman to my left, 
Mr. DeLoss, talked about working with the her community. I also 
work--when I was with SAMHSA, worked with the her community. We 
had developed bridges to allow for patient consent, but the her 
community was not interested because there was not enough money 
in it for them. They had an opportunity earlier in this whole 
discussion when the HITECH Act was passed, they just were not 
interested.
    I met with the major providers. They were not interested. 
This was small potatoes as far as they are concerned. Get rid 
of healthcare operations, and you have got a different bill 
that at least will allow people to address----
    Mr. Green. Well, thank you.
    And, Ms. Metcalf, I understand from where you are coming 
from. But we still have this issue that Mr. McKee said that, 
even as a family member, he wasn't getting information from his 
brother. And that happens whereas I don't know if HIPAA could 
be a change. The only thing I could say, as a lawyer, is that a 
family member gets a guardianship so you take over that 
oversight. And guardianships are tougher, because it is harder 
to get. But as a family, that is the only legal thing.
    Mr. DeLoss, do you have any other options that a family 
member could use?
    Mr. DeLoss. In order to share the information, correct. The 
current bill would not allow that direct sharing. It would 
allow for the sharing only to a covered entity.
    As far as an alternative to share that information in that 
precise situation, there could be an anonymized disclosure. In 
order to avoid some of the implications of Part 2 that are 
overly restrictive and engage in a process to warn others. 
There is no duty to warn exception under Part 2. So, if there 
is an issue where someone should threaten to kill someone, they 
cannot inform police or anyone else under Part 2.
    So what Part 2 programs have done is to anonymize that 
disclosure, disclose it in such a way that does not indicate 
where it came from or who it is about specifically with respect 
to their SUD diagnosis.
    So these are workarounds that SUD programs governed by Part 
2 must undertake in order to avoid these overly restrictive 
requirements.
    Mr. Green. Thank you, Mr. Chairman. I know I am out of 
time.
    Mr. Burgess. The gentleman yields back. The chair thanks 
the gentleman.
    The chair recognizes the gentleman from Oregon, the 
chairman of the full committee, Mr. Walden.
    Mr. Walden. Thank you, Mr. Chairman. And thanks to our 
panelists for being here as we work on this very difficult 
issue.
    I have heard from my hospitals in Oregon who are very 
supportive of what we are trying to do here. They say this 
regulation makes it very difficult or prevents the sharing of 
patient information necessary to deliver effective and 
coordinated care. This conflict forces hospitals and health 
systems now to go to extraordinary lengths to deliver needed 
care.
    In our panel with the survivors, many of whom lost 
children, this was an issue they raised. The lack of ability to 
know what is going on in their kids' lives. We have heard it 
from others about substance use disorder treatment. I know 
these are separate issues.
    But, Mr. Gardner, patients with substance use disorder who 
are currently using illegal drugs, I understand to be the case 
are not protected by civil rights laws, such as ADA, that 
protect those with disabilities from employment, housing, and 
other types of discrimination. The legislation before us 
includes antidiscrimination language, does it not?
    Mr. Gardner. That is my understanding.
    Mr. Walden. And regarding protections for patients seeking 
substance use disorder treatment, does this language strengthen 
or does it weaken the statute behind 42 CFR Part 2?
    Mr. Gardner. Thank you for the question, chairman.
    My understanding is that, although I am not a lawyer, it 
would strengthen protections for the use of such information in 
criminal proceedings, which I think is important.
    Mr. Walden. Well, that is my understanding. And like you, I 
am not burdened by a law degree. I just try and do public 
policy. No offense to those who have passed the bar or stopped 
in there.
    Mr. DeLoss, can you identify the legal mechanisms, if any, 
in this legislation for substance use disorder treatment 
records to get into the hands of landlords, law enforcement, 
and civil and court judges without patient consent or a court 
order?
    Mr. DeLoss. No, there is no possible way to do so under 
this bill. This bill would prohibit those types of disclosures. 
The disclosures would only be allowed for purposes of treatment 
payment operations. Does not include any of those third 
parties. Those third parties do not fall under the definition 
of a HIPAA-covered entity, so those third parties would not 
receive that information. Only certain healthcare providers, 
not all healthcare providers, are governed by HIPAA. So not all 
healthcare providers would receive the Part 2 information under 
this bill. They would be restricted, health plans and health 
care clearinghouses.
    So, in addition to those restrictions against the third 
parties receiving the information, as you have mentioned, there 
are heightened antidiscrimination provisions.
    Mr. Walden. Heightened. Stronger. More than exists today
    Mr. DeLoss. Much more stringent, much more protective than 
current Part 2 protections with respect to antidiscrimination 
in housing, in employment. Protections against use of any of 
this information in any kind of proceeding, civil, criminal, or 
administrative, all of this is far greater in terms of its 
protections than what Part 2 currently provides.
    Mr. Walden. So, if it can't be used to discriminate against 
you in your employment, your housing, any criminal case, 
anything else, what is the only thing it can be used for?
    Mr. DeLoss. Well, it would primarily be used for treatment. 
As we have heard, coordinating care is the biggest issue that 
these SUD programs are facing, is trying to integrate that care 
with HIEs, health information exchanges, accountable care 
organizations, any kind of integrated healthcare environment 
under the Medicaid program. All of this requires coordination.
    And with respect to the ability to share that information, 
the issues that have arisen are so complex in terms of trying 
to comply with Part 2 that these independent entities, these 
ACOs, these HIEs, these are not vendors. These are entities 
that are created to coordinate care. They have refused to allow 
Part 2 information to be included.
    I have worked with several HIEs or healthcare networks that 
have refused to include this information exactly because of the 
Part 2 restrictions. And despite many efforts to create 
workarounds or ways to address these issues will not include 
that information.
    Mr. Walden. So I was in a federally qualified healthcare 
facility in my district, Klamath Falls, Oregon, last week. And 
we talked about this very obstacle to quality healthcare. And 
that is all they care about is the patient and quality 
healthcare. And they said, ``Please, please, please.''
    I said, ``42 CFR Part 2.''
    And they said, ``Yes. You have no idea what an obstacle 
that is to patient safety and treatment.''
    And so that is why we are here. We want to get it right. We 
appreciate all the panelists today sharing their opinions. This 
is important stuff. It is not easy.
    And, Mr. Chairman, thank you for holding this hearing. I 
think it has been very, very helpful.
    Mr. Burgess. And we thank the chairman.
    The chair now yields 5 minutes for questions to the ranking 
member of the full committee, Mr. Pallone of New Jersey.
    Mr. Pallone. Thank you, Mr. Chairman.
    I want to thank all the witnesses for joining us.
    And, Dr. Clark, I am interested in learning more about the 
uptick of substance use disorder treatment in the U.S., so I am 
going to start with you.
    In your testimony, you note that, of the 28.6 million 
people who misuse illicit drugs and the 65 million people who 
are binge drinkers in the past month, only 3.8 million people 
received treatment in the past year. Could you explain some the 
reasons people don't receive treatment for substance use 
disorder? And quickly, because I have more questions to ask 
you.
    Dr. Clark. Sure.
    A number of reasons. The first reason is the ability to 
pay. The second reason is people don't want to stop. The third 
reason and fourth reasons are people do have concerns about 
privacy and stigma. It is an issue that drives people's 
motives.
    And as I pointed out in my 5 minutes and response is that 
we need to get people early and--before we wind up having to 
deal with them later in their substance use.
    Mr. Pallone. All right. So, for you and also Ms. Metcalf, 
could you explain why maintaining Part 2 protections is 
important to individuals seeking treatment for substance use 
disorders, including opioid use disorder? Briefly, again.
    You could start, Dr. Clark, and then we will go to Ms. 
Metcalf.
    Ms. Metcalf. Yes. Thank you.
    42 CFR is important to people seeking treatment because 
they are assured, when they come to treatment, they have that 
conversation about who will receive their information. And they 
have a choice to sign it. And it is a simple conversation. And 
so it is important to actually build--empower those individuals 
to be part of their care. And it allows them to make that 
choice that their physician or the people involved with their 
medical care can have the information that they are in 
treatment.
    If they choose not, there are many, many, many, reasons why 
they might choose not to. For fear in small rural communities 
where they just choose not to share that they have gone to 
treatment for their alcoholism, been in counseling. Lots of 
reasons why they may choose to not share that with a small town 
family physician that is their physician.
    Mr. Pallone. All right. Let me move on.
    Under the proposed legislation, patients would lose the 
right to determine the extent to which their patient record is 
shared for treatment, payment, and healthcare operations but 
receive added requirements related to the use of their part D 
record in criminal, civil, and administrative proceedings as 
well as discrimination by lawful holders of Part 2 information.
    Again, either Ms. Metcalf or Dr. Clark, could you explain 
why the extra protections included in this proposal do not cure 
your concerns about eliminating Part 2's patient consent 
requirements.
    I guess he is asking for you to speak, Ms. Metcalf.
    Ms. Metcalf. The added protections, I think that we are 
still seeing one of our constituents, a member of Faces and 
Voices of Recovery, has shared her story about unlawful sharing 
of her medical records, unlawful redisclosure. The impact on 
her lifelong is that--an inability to start her small business 
as a result of the--unable to purchase group health plan for 
prospective employees based on her health history of substance 
use disorders; despite being her primary breadwinner, unable to 
buy life insurance policy to protect her family based on her 
health history of substance use disorders; and unable to obtain 
disability insurance due to the same.
    So the bill does not protect these individuals from those 
who the health insurer will share that information with, which 
includes extensions of the companies that are related to life 
insurance, disability insurance, and so on.
    Mr. Pallone. All right. Let me ask one more question, Dr. 
Clark.
    Due to the concerns you have expressed with eliminating 
Part 2's patient consent requirements, what actions can 
Congress take to allow patients to further benefit from the 
health system's coordinated care arrangements and still 
maintain Part 2 protections?
    I will ask you that one directly.
    Dr. Clark. One of the things that we would encourage the 
Congress to do, or I would, is to facilitate the acquisition of 
electronic health records by the Substance Use Delivery System, 
which, incidentally, is not primarily populated in hospitals or 
in doctor's offices. It is primarily populated in small 
recovery-type oriented behavioral health treatment systems. So, 
by the time you reach the doctor's office, your problems 
actually are much more severe. So you could do that.
    And one issue that is missing from this is the issue of 
child custody. There is no discussion about that in the bill. 
So, while it says you can't use it about a plaintiff, it 
doesn't say you can't use it about a defendant.
    So these are the kinds of things that need to be 
deconstructed from the bill so that it can enhance the issue of 
protection if that is what your will is.
    I applaud the effort to address these issues. I don't want 
to suggest that the bill, because of its weaknesses, has got a 
bad intent. I think it is a well-intended bill, but I think it 
is inadequate for the purpose that we need to look at these 
things more carefully. And I really applaud the Congress' 
interest in trying to correct some of these problems.
    Mr. Pallone. Thank you.
    Thank you, Mr. Chairman.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    The chair would just observe for the record that I did vote 
against the HITECH Act.
    Now I would like to recognize the gentleman from Texas, Mr. 
Barton, 5 minutes for question.
    Mr. Barton. Thank you, Mr. Chairman.
    And I want to appreciate you and Chairman Walden honoring 
your word at the markup where this bill was not marked up, but 
you promised to hold this hearing. It is good to follow regular 
order and try to get more information.
    I come at this a little bit differently than most of the 
Republicans on this committee. I am the co-chairman of the 
Privacy Caucus here in the House and have been for the last 10 
or 15 years.
    I want to read a very brief part of the majority memo for 
this hearing. It is on the second page of the memo, and this is 
a direct quote: Part 2 regulations provide stronger protections 
for substance use disorder treatment records than do most other 
Federal and State health privacy laws, including the standards 
for privacy of individually identifiable health information, 
parentheses, privacy rule, under the Health Insurance 
Portability and Accountability Act of 1996, parentheses, HIPAA. 
Repeat: Part 2 regulations provide stronger protection than do 
most other Federal and State health privacy laws.
    That is the crux of the issue. Nobody disputes these tragic 
individual stories. The gentleman from Ohio, the gentleman that 
I think is representing Betty Ford whose mother had a problem. 
Nobody disputes that.
    But Part 2 provides stronger protections for individuals. 
Most Federal laws don't. A lot of the so-called privacy 
protections that we have now in Federal law are jokes. They are 
information disclosure laws that, when a breach happens, the 
group that is allowed the breach has to notify you that your 
data has been compromised. They don't protect privacy. They 
just require the group that let the privacy be abused to 
disclose you that it has been abused. And in some cases, 
especially banking, it is not that it has been breached. They 
just have the right to use the information however they want as 
long as they tell you.
    So here we have a law that actually does provide privacy 
protection. And in the name of better healthcare, we are trying 
to breach it. I am opposed to that.
    Now, I am not opposed to some change in Part 2. I 
understand. But I am opposed to just unilaterally overriding 
the individual's right to privacy by requiring written consent.
    Now, I want to ask the gentleman from Ohio, Mr. McKee. Was 
your brother, to your knowledge, ever asked to waive his right 
to privacy under Part 2?
    Mr. McKee. Not that I am aware of.
    Mr. Barton. OK.
    What about you, Mr. Gardner? Was your mother ever directly 
asked to waive her Part 2 rights?
    Mr. Gardner. I cannot answer for sure.
    Mr. Barton. OK. It may be they were never asked. It may be 
they were asked, and they refused to. We just don't know.
    Mr. McKee. Congressman Barton.
    Mr. Barton. Yes.
    Mr. McKee. With all due respect, how would the physician 
have known to ask?
    Mr. Barton. What is that?
    Mr. McKee. How would the physician, how would the surgeon, 
have known to ask?
    Mr. Barton. Well, if I were treating, and I am not a 
doctor, but if I were treating your brother, I know, when I go 
to my dentist, when I go in for any kind of a procedure--I have 
had gallbladder surgery; I had a heart attack--I have to fill 
out a form three or four pages long that has asked if I have 
ever been treated for any of the following occasions. And I 
believe that, if I were a prescribing physician giving fairly 
strong pain medication, I would probably either informally, 
verbally, or formally ask that question.
    Now, in fact, every time I go to my doctor, I have to fill 
out the same form again. And I say, ``Well, I just filled it 
out last year.''
    ``Well, I am sorry. You have got to do it again.''
    So, there are cases--and my time is about to expire. There 
are cases where maybe the patient is not mentally able to make 
a decision. But my guess is a vast majority of the time they 
are competent, and they choose not to disclose for their own 
purposes. Now, I don't know that. That is just a supposition.
    Anyway, I had two more questions I will submit for the 
record, Mr. Chairman, since my time has expired.
    And thank you all, the witnesses, for being here.
    Mr. Burgess. The chair thanks the gentleman. The chair 
recognizes the gentleman from Maryland, Mr. Sarbanes, 5 minutes 
for your questions, please.
    Mr. Sarbanes. Thank you, Mr. Chairman. Thanks to the panel.
    I can't see--all the way on the end. Yes.
    Mr. DeLoss. Mr. DeLoss.
    Mr. Sarbanes. Sorry. I lost track of the witness list.
    You, I think, were describing, in the new proposed draft of 
the bill that has been mentioned here today, that there is some 
antidiscrimination language in there. And I guess that would 
make it illegal for any entity to use records to discriminate 
for healthcare, hiring, employment, sale or rental of housing, 
access to courts, recipient of funds, et cetera. And that gives 
you increased confidence that facilitated sharing of 
information that is suggested by the proposed bill would 
mitigate the occasion for discrimination, therefore, 
potentially be less stigmatizing. So it goes to addressing that 
issue. Is that right? Is that the idea?
    Mr. DeLoss. That is correct, yes.
    Mr. Sarbanes. Yes. And I get that.
    What I worry about is that--that is well and good. But it 
is kind of like the cow is out of the barn. In other words, 
once the data is out there or the information is shared, it may 
be that somebody misusing it is subject to some kind of penalty 
or prosecution or what have you. But as we know in life, a lot 
of times, that kind of discrimination can go unpunished, and at 
that point, the information is out there. So a better 
protection is to keep the information safe or in close hands 
before it even gets out there and you have to test the 
proposition of whether people are handling it properly.
    So I think, I see why people are pointing to that and 
suggesting, ``Well, that should give us comfort,'' I am not 
sure it gives the comfort you are suggesting to a patient who 
is going to say, ``Well, that is fine if someone could get in 
trouble if they misuse my information, but the chances that it 
could get misused are still pretty high, and they might not get 
penalized for it, and there may be no deterrent effect as a 
result, so the better path for me is to just not share the 
information, or that puts me in an exposed position.''
    So I just wanted to make that point, because I think it is 
a fair one. And I wanted to turn to you, Ms. Metcalf, and just 
ask you----
    Mr. DeLoss. Could I quickly respond?
    Mr. Sarbanes. Yes, you could.
    Mr. DeLoss. Thank you.
    The issue that I see in response to those concerns, which I 
think are valid, is that the current Part 2 regulations, even 
though there is a consent process, because they are so overly 
stringent and technical, it doesn't allow the patient to make 
that choice, because the recipients, such as HIEs or ACOs or 
these integrated care environments that are part of the new 
healthcare model, would not accept that information.
    So, even if the patient made the choice to share the 
information, it couldn't be accepted because those entities 
would refuse it. In addition, the recipients would have to 
segment that data if they did receive it so it would not be 
redisclosed. Again, something that certain electronic health 
records do not have the current capability to do.
    And in addition, with respect to the bill itself, in 
addition to the antidiscrimination provisions you mentioned, 
there is a limited set of recipients that could receive this 
information so it is not going out to third parties. It is not 
going out to billing agencies. It is not going out to 
marketers. It is not going out to businesses----
    Mr. Sarbanes. Let me jump in, because now I am down to 14 
seconds. So I won't to ask you this question, Ms. Metcalf.
    Mr. DeLoss. Thank you.
    Mr. Sarbanes. My understanding is that, even keeping the 
key components of the Part 2 regulations in place, that through 
education, through finding ways of streamlining some of the 
technical obstacles that people are concerned about, that we 
could improve the situation for coordinated care without 
compromising the concerns people have about the privacy of the 
data. So that is why I continue to have some misgivings about 
the proposed legislation here that we are talking about.
    With that, I will yield back.
    Thank you.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    The chair recognizes the gentleman from Kentucky, Mr. 
Guthrie, 5 minutes for you questions, please.
    Mr. Guthrie. Thank you very much, Mr. Chairman. Thanks for 
having this meeting.
    The first few questions are for Mr. DeLoss. I am going to 
try to ask some on behalf of my good friend from Texas, Mr. 
Barton.
    But, first, Mr. DeLoss, it is my understanding that Part 2 
only applies to federally supported providers who identify 
themselves specifically providing SUD treatment and referrals. 
Are there health providers, say office-based physicians, 
prescribing buprenorphine or for-profit providers that do not 
fall into this category and do not have to comply with Part 2?
    Mr. DeLoss. That is correct. There are certain providers 
that do not have to comply with Part 2 because either they are 
not federally assisted or do not hold themselves out as 
specializing in this area.
    Mr. Guthrie. So what about the Department of Veterans 
Affairs? And does it make sense that some patients with 
substance abuse disorders will have this information in their 
medical records and some will not?
    Mr. DeLoss. With respect to the Department of Veterans 
Affairs, that would be an exclusion from the coverage of Part 
2. Part 2 would not apply to those records.
    Mr. Guthrie. Does it make sense that some would have this 
information and others would not?
    Mr. DeLoss. No. It leaves an incomplete record. Absolutely.
    Mr. Guthrie. So, while Part 2 is supposed to have stronger 
protections, Mr. DeLoss, can you discuss the enforcement 
authority for Part 2 infractions in comparison to the 
enforcement authority for HIPAA violations?
    Mr. DeLoss. Yes.
    Part 2 is a criminal statute, so the enforcement, in 
addition to the Substance Abuse and Mental Health Services 
Administration, SAMHSA, there would be a criminal enforcement 
through the Department of Justice. To my knowledge--and I know 
Dr. Clark had a differing opinion. To my knowledge, there has 
never been a substantive enforcement action taken for a 
violation of a Part 2 provision in its history.
    With respect to HIPAA, you have the Office for Civil 
Rights, Department of Health and Human Services, that would 
engage in a process of audits, reviews, complaint-driven 
responses, investigations. You have the breach notification 
provisions which are now part of Part 2 under the bill. I did 
not mention that earlier. All of that results in a very 
comprehensive enforcement scheme. And I believe the most recent 
information I have is that over $75 million in fines and 
penalties have been levied against those that have violated 
HIPAA or not complied completely with respect to the 
protections that that law requires.
    Mr. Guthrie. OK. And I am going to ask a question on behalf 
of my friend from Texas he said he didn't get to, so I am going 
to read it.
    Substance use disorder treatment records--and this is for 
Mr. DeLoss--has already been subject to data breaches. For 
example, in August 2016, an addiction treatment provider in 
Baltimore was hacked, and patient addiction treatment 
information was put up for sale on the dark web.
    In 2017, a data breach of Bronx Lebanon Hospital Center in 
New York calls the release of at least 7,000 people's records, 
which included addiction histories.
    So, that said, under Part 2, are there currently breach 
notification requirements?
    Mr. DeLoss. Correct. The HIPAA breach notification 
requirements would require notification not only to the 
individual patients, probably in the cases you mentioned, to 
the media as well as the Department of Health and Human 
Services.
    Mr. Guthrie. Under Part 2, what are the penalties for an 
unauthorized disclosure?
    Mr. DeLoss. Well, they can range from $100 for a small 
negligible type of violation up to $1.5 million.
    Mr. Guthrie. So how would the legislation before us help 
patients whose addiction treatment data has been compromised?
    Mr. DeLoss. Well, there would be a requirement and 
affirmative duty to report any type of breach or violation 
under the breach notification provisions. Part 2 does not 
currently require any kind of notification of a violation by a 
program--or by a provider. So there would be that new 
affirmative obligation to disclose that, not only to the 
individual patient but also to the department as well.
    So that would obviously bring up the ability--or heighten 
the ability to enforce the law, because it would impose an 
affirmative obligation to do so.
    Mr. Guthrie. Thank you. And I have about a minute.
    So, Mr. Gardner, the Assistant Secretary for Mental Health 
and Substance Use, Elinore McCance-Katz, wrote recently in a 
letter that, and I will read a paragraph from her letter, the 
practice of requiring substance use disorder information to be 
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 of care.
    I have 30 seconds, Mr. Gardner. Do you agree with that 
statement?
    Mr. Gardner. That is a big subject for 30 seconds, but I do 
believe that, over the course of time, a paradigm of separation 
and secrecy as opposed to integration and openness does, 
indeed, create a culture where stigma lives.
    Mr. Guthrie. Well, thank you, and my time is expired.
    And I yield back.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    The chair recognizes the gentlelady from California, Ms. 
Matsui, 5 minutes for your questions, please.
    Ms. Matsui. Thank you, Mr. Chairman.
    I want to thank all the witnesses for being here today.
    Mr. DeLoss' testimony highlights that, under this bill, a 
Part 2 provider could still require additional consent if it 
wanted to. There may be a way for this bill to reflect that 
option more directly. I recognize that Mr. McKee's brother 
story is an all too common scenario in which the patient may 
have not chosen to consent even if sharing the information will 
be in their best interest. However, I think the big question we 
must ask ourselves is whether we want to completely take away 
that right to consent.
    I think middle ground here is retaining some ability for 
the patient to consent to whether or not the information is 
shared. Under current Part 2 law, the patient has a right to 
consent either every time their information is shared or, under 
new SAMHSA rules, more broadly if they chose. Under the current 
bill we are considering, a patient's information would be 
shared automatically with covered entities for the purposes of 
treatment, payment, and healthcare operations when they choose 
to be treated.
    What if, upon seeking treatment, the patient retained the 
right to consent and could choose between privacy protections 
under 42 CFR or under HIPAA?
    Dr. Clark, I will start with you, but I would like to hear 
from the other witnesses as well.
    Dr. Clark. As I mentioned, I applaud the efforts of this 
committee to address some of these critical issues, because 
they are of great concern to our nation's public health and to 
the citizens of this country.
    You raise an important point that, essentially, already 
exists, has already been acknowledged. You can strengthen 42 
CFR Part 2 by strengthening the penalty without abandoning the 
confidentiality and right to make a personal decision.
    There are conflict of laws issues that are raised by the 
current bill that will have to be negotiated, because, indeed, 
it attempts to abrogate things like the ADA, the DOT, and 
Department of Justice kinds of rules.
    So then there is the issue of competency of individuals. If 
you remove an individual's competency in this situation 
automatically, then what about for cancer? What about for other 
conditions?
    So the right to choose what happens to your own person is 
an important right. And what we are talking about is creating a 
slippery slope where we nullify that right for this condition, 
and then we have to nullify that right for another condition. 
So I think we need to keep that in mind. Addressing the 
conflict of laws, addressing the issue of penalties, and making 
sure that we understand the covered entities.
    Ms. Matsui. OK. Any other comments to this at all?
    Mr. DeLoss. I can respond briefly.
    Ms. Matsui. Yes.
    Mr. DeLoss. In terms of requiring the consent, I believe 
that one of the issues would be in what situation would consent 
be required. Even with the changes that were made in the 
regulations in 2017 to 2018, there are still issues exchanging 
that information directly with other healthcare providers 
because of the limitations that are imposed and because of the 
complexity of those regulations.
    And I think that probably really sums up the critical 
issue, which is, because of those complexities, that health 
systems, medical groups, hospitals, and others cannot comply 
with, the HIEs, ACOs, et cetera, this information is not being 
included in those exchanges of information for purposes of care 
coordination. So a consent by itself does no good. But if you 
add the layers of complexity that are in place currently under 
the law as well as others that have been proposed by the 
opponents to this bill, then it makes it extremely difficult, 
if not impossible, to share that information.
    Thank you.
    Ms. Matsui. All right. Now, I realize that both HIPAA and 
Part 2 protect against information be shared with landlords, 
employers. But I am concerned that the definition of covered 
entity under HIPAA may still be too broad such that it 
increases the likelihood of a breach.
    Mr. DeLoss, under this bill, could information only be 
shared between treating providers, or could it be shared 
between two covered entities that are not necessarily treating 
the specific patient?
    Mr. DeLoss. The information could be shared for treatment 
payment or healthcare operations only between two covered 
entities. A Part 2 program and a covered entity and then a 
covered entity with another covered entity downstream and 
definitely, correct.
    Ms. Matsui. I heard differing opinions on whether H.R. 3545 
allows for disclosures to business associates.
    Are business associates not covered under payment treatment 
and operations under HIPAA?
    Mr. DeLoss. It is my interpretation of H.R. 3545 that the 
bill would not allow disclosure to business associates because 
they are not ``covered entities,'' correct.
    Ms. Matsui. OK.
    Mr. Chairman, I yield back. Thank you.
    Mr. Burgess. Does the gentlelady yield her time to me?
    Ms. Matsui. Yes, I yield to you.
    Mr. Green. I thank my colleague.
    Mr. Chairman, you and I talked about this. I would like to 
ask. Mr. DeLoss testified that the bill would not allow 
information to be shared with business associates. However, a 
Republican memo states, ``the discussion draft will permit said 
records to be shared between covered entities, healthcare 
providers, payers, and business associates.''
    I would like to see if Mr. DeLoss can clarify as to the 
intent to just include entities, or is it also the intent to 
include business associates?
    Mr. Burgess. Before we go into that, it is not Mr. 
DeLoss'--it is not required of him to----
    Mr. Green. Oh, no. He doesn't have to. I would just like--
--
    Mr. Burgess [continuing]. To justify what is in the 
majority memo. He is responsible for his testimony. We are 
responsible for ours.
    You are welcome to address that if you would like. But you 
are not required to.
    Mr. DeLoss. Again, it is my interpretation--I am not 
familiar with the memo, and I--it is my interpretation that, 
because it allows for disclosures from Part 2 programs to 
covered entities or by covered entities to covered entities, 
that business associates would not be included. That is my 
interpretation.
    Mr. Green. Thank you. I just wanted to get the----
    Mr. Burgess. Thanks. The gentleman yields back.
    The chair recognizes the gentlelady from Tennessee, Mrs. 
Blackburn, 5 minutes for your questions, please.
    Mrs. Blackburn. Thank you, Mr. Chairman.
    And I thank you all for your patience in being here today 
and talking with us about this issue.
    As you know, we had quite an extensive hearing prior to 
your hearing today with the drug distributors and looking at 
the opioid issue and their participation in it. So this is an 
issue that we take very seriously.
    And as Chairman Walden said, one of the things we have 
heard from families, from those that are recovering from 
addiction, that have suffered from addiction, is wanting to 
have visibility into those records so that they could be there 
to help their family member or their loved one.
    And Ms. Matsui was just touching on the consent forms. And 
I want to go back to that issue but take a little bit different 
tack with this. Because I was talking with an attorney 
yesterday, and we were talking about someone they were trying 
to get into drug court and a treatment program. And this person 
had looked at this attorney and said, ``You can take me to drug 
court. They can send me to detox. But I am not going to stop 
using.''
    And he talked about the heartbreak. And I think many of us, 
and you all, Ms. Metcalf, your situation; Mr. McKee, with your 
brother; Mr. Gardner, with your mom, those are the 
heartbreaking, heart-wrenching situations that those--as a mom 
and as a friend to people who have dealt with this, it just 
tears you apart. And we realize that.
    Ms. Metcalf, I want you to just say what would it have 
meant to you if there was somebody else that had that 
visibility and, we hear from doctors about compliance or about 
people maybe telling the truth but not the whole truth when 
they come in and have a discussion about their health. What 
would it have meant to you to have somebody with the visibility 
that could say, ``You need to sign this consent form; you need 
to be truthful and honest about this''?
    Just give me 30 seconds on that.
    Ms. Metcalf. Absolutely. Thank you.
    And it meant an awful lot to me. I had a physician and my 
mother that said--when I was 17 years old, worked together to 
coordinate my care. And I signed a consent form, because my 
counselor said that this would be a good thing, to work 
together as a team. I was prescribed Antabuse at the age of 17, 
because I was drinking excessively and had been to treatment 
twice. And so they coordinated together.
    It made a lot of sense to me to work together, and I 
consented and signed that form as a 17-year-old. I would do it 
again because I was educated in that I was given the 
opportunity to make a choice.
    Mrs. Blackburn. Now, as you work with those that are 
recovering, how do you counsel them?
    And, Mr. Gardner, I want you to come in right behind her on 
that answer.
    How do you counsel people on signing a consent form?
    And, Ms. Metcalf, you first, and then Mr. Gardner.
    Ms. Metcalf. I worked as an intake worker in a residential 
treatment program and had those conversations many, many times. 
It was a very validating experience to have to say this is what 
that form is, 42 CFR Part 2. If you would like to share your 
information with your physician, you can sign it now. Or as you 
are here in treatment with us, we will revisit this, because 
you may want to coordinate the care.
    I believe that having others make a choice for us or even 
having this conversation is stigmatizing in a way that says 
that we don't have the ability or that we are less than, that 
we don't--we are not capable of making those choices, and we 
are. There are millions of people that are making those choices 
every day and consenting to sharing information with their 
healthcare providers.
    Mrs. Blackburn. Would you say that consenting to share that 
information and get that helped save your life?
    Ms. Metcalf. I don't know that. The prescription that I was 
given didn't save my life. It didn't work for me. I went on as 
an adult to treatment.
    Mrs. Blackburn. OK.
    Mr. Gardner.
    Mr. Gardner. Thank you for the question.
    I do think those are compassionate conversations. I will 
say that I don't think patients generally have an expectation, 
come in with some expectation or knowledge of Part 2, some 
difference between HIPAA and Part 2. They have some general 
expectation of privacy, for sure. And I will say that when we 
come back for repeated consents, in the real world, that is 
sort of annoying, frustrating sometimes, and can actually raise 
alarms, like what wasn't I thinking about that I need to be 
thinking about now?
    Mrs. Blackburn. OK. I yield back.
    Mr. Burgess. The chair thanks the gentlelady.
    The chair recognizes the gentlelady from California for 5 
minutes for questions, please.
    Ms. Eshoo. Thank you, Mr. Chairman.
    And thank you to all of the witnesses.
    I have had the advantage of being able to not only listen 
to your testimony but also to listen to all of the questions 
from members on both sides. And there are enormous complexities 
in this. I don't really think there is a tidy answer to this. 
And I say that because I keep thinking of my first cousin who 
suffered all of his life from mental health issues, from the 
time he was in his early 20s until he passed away maybe about 6 
months ago. And he didn't really fit into what we are talking 
about here today in many ways, because if you said to him, 
``Give consent,'' he really would not have known what he was 
talking about. He wasn't in a position to do that.
    So I want to thank Dr. Clark. He is a part of a great 
university in my region, Santa Clara University. It is a Jesuit 
college with a graduate school, and it is highly regarded for 
many of its graduates, one of them a member of Congress, a son 
of the House, Leon Panetta. So thank you for being with us.
    What I would like to know is, from among yourselves, Mr. 
Gardner, what would you and Mr. McKee say to Ms. Metcalf? Ms. 
Metcalf, what would you say to them?
    You believe that Part 2 is necessary, and you told your 
story, and it is an important one. They told their stories. 
They are an important one.
    What is lacking in HIPAA? Where is the danger going to come 
from if we change this? So----
    Ms. Metcalf. Yes.
    Ms. Eshoo [continuing]. Maybe the three of you, in a 
minute, tell me why your case, you believe, is the strongest.
    Ms. Metcalf. I will go.
    And I wanted to say that, we hear these stories, and it is 
very impactful. I think that when a person with a substance use 
disorder wants to share their information with a family member, 
they will. I don't know that signing a HIPAA is going to allow 
them to--or is going to help that. I think that the family 
member doesn't have access to that information.
    Ms. Eshoo. See, the thing--and what you are saying to me 
is, and maybe my own experience is discolored by the fact that 
my cousin really was not capable. If he said so, he sounded and 
he looked very clear, but he really didn't know what he was 
talking about a good part of the time. So is that what we are 
relying on?
    Ms. Metcalf. I think we have a very misconstrued image of 
what alcohol and drug addiction is. There are millions of us--
23 million in recovery. There are individuals who go on to live 
and overcome addiction. We are not----
    Ms. Eshoo. And this applies only to alcohol and drug abuse? 
What we are talking about today, it only applies to those two 
addictions? It only applies to those two addictions?
    Ms. Metcalf. Yes.
    Mr. McKee. I would say that by enshrining this distinction 
between medical and surgical care and substance use disorder 
conditions that, in the Federal code, we are simply adding to 
the stigma in a structural way.
    There are other health conditions that are highly 
stigmatized, like sexually transmitted infections, HIV/AIDS. 
Why are we separating out substance use disorder information?
    I work for NAMI. There are a lot of folks that we represent 
that are seriously mentally ill.
    Ms. Eshoo. That is an extraordinary organization. I worked 
with them for years. They really are outstanding.
    Mr. McKee. Thank you, Congresswoman. We appreciate that 
very much. And there are a lot of folks with serious mental 
illness, like your brother--or your cousin, who simply don't 
understand this process. And yet their treatment providers of 
either mental health provision or medical/surgical care are 
still blocked from seeing these things.
    It is almost as if we are----
    Ms. Eshoo. Let me give Mr. Gardner just a moment. I 
appreciate what you are saying.
    Mr. Gardner. Yes. Thank you.
    I think in the specialized addiction treatment field, we 
have recognized for a long time that the way to--one of the big 
opportunities to improve the way addiction is addressed in 
America is to get all of healthcare involved and not have it be 
just us in the specialty treatment field.
    And so every opportunity I think we can get to bring 
healthcare into the fold and get more eyes and professionals on 
this disease for the people that suffer from it, I think the 
better. And this seems like an opportunity to do that.
    Privacy is important is what I would say. There is no doubt 
about it. I just think the strategy that we had in the 70s of 
trying to avoid discrimination is no longer the right strategy. 
We should be confronting discrimination, and I think we have 
with--in HIPAA and the newly--the new language around Part 2 
that we enforce discrimination and still bring healthcare into 
the fold.
    Ms. Eshoo. Thank you very much.
    Thank you, Mr. Chairman.
    Mr. Burgess. The chair thanks the gentlelady.
    The chair recognizes the gentleman from New Jersey, Mr. 
Lance, 5 minutes for your questions, please.
    Mr. Lance. Thank you very much, Mr. Chairman.
    And good afternoon to the panel.
    I will be introducing a bill that will target new resources 
for substance use disorder. Health homes, as I understand it, 
they currently exist in four States: Maine, Maryland, Rhode 
Island, and Vermont.
    Under the model of care in Vermont, for example, the State 
has markedly expanded access to medication-assisted therapy; 
reduced the use of alcohol, opiates, and other illicit drugs; 
decreased the use of hospital emergency room departments; 
reduced illegal activities and run-ins with law enforcement; 
and substantially improved family life, housing stability, and 
emotional health.
    However, according to a January 2015 bulletin put out by 
CMS entitled ``Designing Medicaid Health Homes for Individuals 
with Opiate Dependency: Considerations for States,'' one 
barrier to effective treatment in care coordination identified 
by Vermont and other participating States was 42 CFR Part 2, 
and ``Collectively, the three States cited Federal 
confidentiality requirements as a barrier to effective 
integration of care and sharing of vital information between 
the health home and other medical professionals.''
    And, Mr. Chairman, I ask that the CMS study be submitted to 
the record.
    Mr. Burgess. Without objection, so ordered.
    [The information appears at the conclusion of the hearing.]
    Mr. Lance. Thank you, Mr. Chairman.
    I know that you don't know the particulars of my bill, but 
it seems like a way forward. And that would be to align Part 2 
with HIPAA. And I think that people on the ground tend to agree 
with this.
    Mr. DeLoss, would aligning Part 2 with HIPAA eliminate the 
barrier to effective integration of care in sharing of vital 
information between the health home and other medical 
professionals? And what sort of improved outcomes for patients 
could we expect to see if this were the case?
    Mr. DeLoss. Well, again, without seeing the bill, but based 
upon your description, it would appear to me that aligning 
HIPAA with Part 2 would allow for the free flow of information 
between those entities as well as substance abuse and substance 
use disorder Part 2 programs. So that would coordinate the 
care, allow that information to be shared for the betterment of 
the quality of the care as well as ensuring that there is any 
type of drug that could interact negatively with anything that 
the individuals currently taking in the form of MAT or what 
they may, as mentioned earlier, as far as their addiction 
itself.
    Mr. Lance. Thank you.
    Is there anyone else on the panel who would like to 
comment?
    Yes, Dr. Clark.
    Dr. Clark. I would like to remind people that most 
substances don't have medications available to treat them and 
that we are talking about essentially blaming individual 
autonomy and rights for the failure of the HITECH Act, the 
failure of practitioners to be adequately trained to address 
the issue of addiction. So we are blaming the very people we 
are trying to help for the weaknesses of the delivery system.
    You just had a hearing this morning. You had people 
throwing large amounts of drugs into the delivery system 
without question, making money hand over fist, and no one 
questions that now. We recognize: Oh yes, we should have 
recognized that large numbers of pills going into a community 
might be a problem.
    We have heard of physicians just writing prescriptions 
without recognizing that this is an issue.
    I treated patients a long time ago, and we always asked: Do 
you want your family involved? You need your family involved, 
because this is a family disease. It is not just your own 
individual disease.
    So what we are talking about is not dealing with the 
system; we are talking about blaming the victim. And I 
encourage you to look at part J of this bill 3545, which says: 
to develop and disseminate model training programs for 
substance use disorder patient records, to get people, to make 
sure we have enough pilots to prove the point rather than to 
speculate the point. Because once the horse has left the barn, 
you can close all the doors you want, but you don't have the 
horse.
    Mr. Lance. Thank you. Others on the panel?
    I commend to your attention the bill that I will be 
introducing, and I certainly would like you to examine it for 
your expertise. This is an issue that knows no bounds here in 
Congress. It is an issue on which we hope to work in a 
bipartisan capacity and also in a bicameral fashion, because 
obviously, we want to improve the system together.
    Thank you very much, and I yield back the balance of my 
time.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    The chair recognizes the gentlelady from Florida, 5 minutes 
for your questions, please.
    Ms. Castor. Thank you, Mr. Chairman and Mr. Green, for 
organizing this hearing today. And I would like to thank all of 
the witnesses for being here, especially for those of you who 
have shared very personal stories. Thank you very much.
    Ms. Metcalf, I would like to get a better understanding of 
the importance of Part 2's patient consent requirement. What 
role does getting patients' consent to disclose their substance 
use disorder treatment information to providers and other 
entities play in their treatment? And why is this patient 
consent requirement important for individuals with substance 
use disorder?
    Ms. Metcalf. I would like to respond to that. What we find 
with people in active addiction is that they are using very 
little healthcare services for preventive care. They are not 
getting treated for the conditions that are underlying. They 
are not doing things that are healthy and seeing dentists or--
there are so many things that can be done to help that person.
    Once they engage in treatment, that conversation about 
their health and wellness, taking care of those things to help 
them live better and longer lives, it happens because the 
counselor talks to them about the value of sharing that 
information with their physician. And we have seen, you know, 
incredible life improvements of people in recovery when they 
are able to do that.
    That is a process that takes place that initially people 
are not generally----
    Ms. Castor. Is there data on that? Are there studies you 
can point on?
    Ms. Metcalf. I have studies of people in long-term 
recovery, the Life in Recovery Survey that indicates what 
recovery does for people. It helps them engage in those medical 
services where they weren't before. And the services they were 
using before were the higher cost emergency department services 
or treatment services versus the preventive care where they 
could be going to their physician.
    Ms. Castor. What should providers do if substance use 
disorder patients refuse to give their consent to disclose 
their patient information to other health providers?
    Ms. Metcalf. They should continue to have that conversation 
with them; and when they are ready and they see the value of 
that, they will do that in most cases.
    Ms. Castor. Because the relationship between the patient 
and the provider is critical, especially with folks with 
substance use disorder. The cornerstone of the relationship, of 
course, is trust, which includes trust that the information you 
give to your provider will be used appropriately and that you 
know how it will be used.
    According to one recent study, two-thirds of adults in 
America are concerned about a breach in the security and 
privacy of their personal health information. In addition, the 
study showed that over 12 percent of patients withheld 
information over privacy concerns. The more concerned you were 
about privacy, the more likely you were to withhold 
information. And I am hearing that this is called your privacy 
protective behaviors. There has got to be a simpler term for 
that.
    But, Dr. Clark, for people with substance use disorders, 
all of you know that that relationship is important between the 
patient and the provider. Would you say that people with 
substance use disorders are particularly sensitive to concerns 
about how their data would be used?
    Dr. Clark. That has been my clinical experience. But, as 
Ms. Metcalf pointed out, the job of the professional in the 
treatment arena is to encourage individuals to recognize the 
importance of comprehensive interventions. And that way, they 
can sample the kinds of reactions that they get. I have heard 
people in other settings who are in recovery point out that 
they, in fact, were dropped by practitioners for what appears 
to be essentially manufactured reasons.
    You can't determine whether you have been discriminated 
against. You just know that these practitioners are 
unavailable. The problem with the HIE notion is that you may 
have hundreds of thousands of entities who have access to that 
information, and they get to decide whether they want to see 
you or not, and they don't have to see you.
    Ms. Castor. But Mr. DeLoss I thought made some good 
points--and I note you are sitting right next to him and 
heard--that this is very narrow and could be helpful when we 
are talking about the covered entities. You heard what he said 
and how narrow it is and why it doesn't----
    Dr. Clark. OK. I disagree with his definition of how narrow 
it is. Remember, this is your bill, not his bill. So his 
interpretation won't control. Your interpretation will control. 
You are making this. He doesn't get to talk about legislative 
history. He gets to litigate it if that is an issue.
    Ms. Castor. We are building the record. We are building the 
record here.
    Dr. Clark. So some of the statements he has made in terms 
of third-party notification, 42 CFR Part 2 does report third-
party notification. You do have to go through extra steps, but 
it does permit third-party notification. So he was wrong about 
that, so he is probably wrong about whether the covered entity 
construct is as limited as he thinks it is.
    So we have to think about that collectively rather than 
just sort of extemporaneously make a declaration.
    Ms. Castor. I wish I had time to allow him, Mr. DeLoss, to 
respond, but maybe another member could ask about that.
    Mr. Burgess. I think we should allow Mr. DeLoss to respond.
    Mr. DeLoss. Thank you. 42 CFR Part 2, to respond directly 
to Dr. Clark's statement, does not have a duty-to-warn 
exception.
    Dr. Clark. It does have a duty-to-warn exception. It does.
    Mr. DeLoss. No, it does not.
    Dr. Clark. It does. It permits third-party notification. 
You should read it a little more closely, sir.
    Mr. Burgess. The gentleman from Texas is correct; the 
witnesses don't get to debate.
    Dr. Clark. It is not a debate here.
    Mr. Burgess. It is now in order to recognize Mr. Long of 
Missouri, 5 minutes for your questions, please.
    Mr. Long. Thank you, Mr. Chairman.
    And, Mr. McKee, one recent study found that physicians 
continue to prescribe opioids for 91 percent of patients who 
suffered a nonfatal overdose, with 63 percent of those patients 
continuing to receive high doses. Seventeen percent of these 
patients overdosed again within 2 years. How will this 
legislation before us help to stop overdoses and prevent these 
deaths from occurring?
    Mr. McKee. Thank you, Congressman. Assuming both of my 
hands are covered entities, it lets the left hand know what the 
right hand is doing.
    Mr. Long. A pretty good explanation, I would say. Do you 
think that allowing health providers to see patients' complete 
medical record when making treatment decisions would help to 
prevent such tragedies as in the case of your brother?
    Mr. McKee. I think it is very likely that improves their 
odds of surviving.
    Mr. Long. Your brother, you said 36 years old at the time 
he deceased, three children, divorced, living in your mother's 
basement. You had fought this, he had fought this addiction, 
your family had fought this addiction for years and years and 
years.
    What can we do, as Congressmen, what can we do here in 
Washington, D.C., to prevent another 36-year-old brother 
deceasing such as yours?
    Mr. McKee. Thank you, Congressman. H.R. 3545 is a great 
step. We also have to improve access to prevention, treatment 
services, ensure that folks are covered, ensure that essential 
health benefits are maintained, such as those requiring 
substance use disorders to be covered. And we also have to 
ensure that we really truly have behavioral health parity in 
this nation.
    Mr. Long. We have had several panels and discussions on 
this topic here in Energy and Commerce Committee. And a few 
weeks ago, we had I believe seven family members that had all--
or seven folks that had all lost family members, usually 
younger college age students and things.
    There is one fellow that works here in Washington, D.C. And 
I was describing at a function one night about how my two 
daughters, one was 29--I better get this right--and one will be 
32 I think in a few more days, but how they had had three 
friends of theirs that have deceased from opioids. And when we 
had the panel in here with the seven parents that had lost 
children and the one lady that was addicted herself and had 
been since a young, young age.
    It had to be extremely frustrating dealing with your 
brother over the years, trying to help him. We had, as I 
started to say, one fellow that worked here that had a son, as 
I was describing at this dinner, about his son had just gotten 
out of treatment for the third time at Christmastime, and they 
opened packages, and the boy disappeared. And he told his wife, 
he said, ``Well, you know, we need to check in on him.'' They 
hadn't heard--they went upstairs, found him collapsed, as you 
described, in a fetal position on the floor of the bathroom. In 
this case, they were able to revive him, got him to the 
hospital. The next morning, they walked in, and he told his 
dad, he said, ``Dad,'' he said, ``I knew when I got out of 
treatment I couldn't do the amount of heroin that I had done 
before,'' but he said, ``My gosh, Dad,'' he said, ``I just had 
such a tiny bit on the spoon, I could barely melt it.''
    Is there anything you can enlighten us with that would help 
these families that are where you were before they have lost 
these loved ones?
    Mr. McKee. That is a great point. When Brandon called me, 
he talked about how he had been off opioids for about a week 
and a half, and he had gotten dope sick. And then he relapsed. 
He didn't know about medication-assisted treatment or there was 
enough stigma around medication-assisted treatment that he 
didn't access it. He was an all-or-nothing kind of guy.
    And I think that when you align things like this, 42 CFR 
with HIPAA, you are simply showing that this is a disease. 
These are chronic brain diseases. And the public needs to 
understand that they are no different than HIV/AIDS, diabetes, 
cancer. The more we have these discussions, the more we break 
that stigma, just like with mental illness.
    Mr. Long. Thank you for sharing your story here today. And 
thank all of you for being here. And the fellow I was talking 
about, his son has, since receiving the injection that you 
get--I think it is once a month maybe, and it is expensive. It 
is a thousand dollars a month, but, for people that can afford 
it, that is fine, those that can't--but, anyway, thank you.
    And, Mr. Chairman, I yield back.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    The chair recognizes the gentleman from Illinois. Mr. 
Bucshon, 5 minutes for your questions.
    Mr. Bucshon. Thank you very much, Mr. Chairman.
    I was a cardiovascular and thoracic surgeon for many years 
before coming to Congress, and I just want to describe a few 
personal experiences--my wife is an anesthesiologist--with what 
can happen when you have an incomplete medical record.
    I will just describe one patient who is a lady in probably 
her mid 70s who I did an aortic valve replacement on. She was a 
nice lady. In her medical history, there was nothing about 
alcohol abuse. However, the second night after surgery, she 
went into DTs, jumped over her bed rail, landed on her head. 
And when I subsequently went and talked to the family, they 
said, ``Well, actually, you know, she drinks quite a bit.'' I 
am like, ``Well, why didn't you tell us that up front?'' It 
wasn't in her record. We had no idea. She had been in 
Alcoholics Anonymous in the past, relapsed. This is a real 
problem.
    And it is not just alcohol or narcotics. I have patients 
that take dietary supplements for vascular health. Well, let me 
just give you a little clue. When you have open heart surgery 
and you are taking medication for vascular health, you bleed 
like crazy and you won't stop. We had no idea. I have had three 
or four patients with that. They didn't tell us. We asked 
specifically, do you take dietary supplements? Didn't tell us.
    And then my wife as an anesthesiologist, and I don't have a 
specific case, but has routinely had problems anesthetizing 
patients with narcotic and benzodiazepine-related anesthetic 
agents, and subsequently has found out from the family, even 
though the patient denied it, that they chronically use opioids 
and/or benzodiazepines.
    Patients don't tell you these things, and it is a really 
big problem. We need to know. Physicians, real physicians out 
there in practice need to know, because it has real 
repercussions. My patient who jumped over the rail and hit her 
head subsequently, after about 2 weeks in the hospital, 
survived her DTs and her aortic valve replacement and her minor 
concussion, but they may not.
    So, Dr. Clark, in your written testimony, you say: The case 
is often made that healthcare delivery systems need to know 
about the substance use history of a patient. You don't hear 
why providers simply can't ask patients themselves about their 
substance use histories.
    Do you really believe that patients are going to tell you 
about these things, I mean, every patientis going to tell you 
when you ask them?
    Dr. Clark. Well, sir, every patient is not going to tell 
you everything about everything. On the other hand, if, in 
fact, you take the time or you have a staff person who can take 
the time to establish the rational relationship between what it 
is that interventionist is going to do, I think you will get 
more truth-telling than you are aware.
    I have found that asking people things in a carefully 
designed nonjudgmental way gets a better response than simply 
reading it in the chart and deciding that you may or may not--
--
    Mr. Bucshon. Fair enough. So the thing is you are a 
psychiatrist.
    Dr. Clark. Yes, I am.
    Mr. Bucshon. People come to you because you need to ask--
because they have been sent to you to ask questions about 
mental illness and substance abuse things. Of course, I 
appreciate your experience, but I can tell you when you are not 
a psychiatrist and you are just a practitioner, a heart 
surgeon, an anesthesiologist, in my personal experience, 
patients do not tell you the full picture.
    And it is not a criticism of them. Many people don't know 
the impact, the potential impact, medical impact of not telling 
you. You know, for example, why would a dietary supplement be a 
problem if you are going to have heart surgery? Well, they 
don't realize the fact that it really does anticoagulate you 
and you bleed, right, and you have to be transfused. I have had 
this happen. So I appreciate your experience, but I would argue 
that the patients don't tell you, and there are real 
repercussions.
    The other question I have is, can you disclose to people's 
employers or law enforcement people's HIV or mental health 
status without their consent?
    Dr. Clark. Generally not, but it also depends on the 
context of the situation.
    Mr. Bucshon. Right. OK. So I get that. And there is some 
context, right? If they are threatening someone or something 
like that, there are exceptions, right?
    So why would you think if there is a history of substance 
abuse or alcohol abuse in a patient's medical record already 
covered by HIPAA, why would you think that there would be a 
high risk of that being disclosed?
    Dr. Clark. Well, actually, HIPAA's protection is weaker 
when it comes to such disclosures. I think 3545 makes an 
attempt to address that. HIPAA does allow administrative police 
inquiries. So you----
    Mr. Bucshon. Yes, but from what Mr. DeLoss says, you have 
to have a court--you can answer that, Mr. DeLoss.
    Mr. DeLoss. You need a court order; that is correct.
    Mr. Bucshon. What is the requirement?
    Mr. DeLoss. You have to have a court order.
    Mr. Bucshon. Or the patient has to authorize it?
    Mr. DeLoss. Correct.
    Mr. Bucshon. OK. So, what I am saying here is, look, I 
appreciate your experience on this issue, but what this 
legislation is trying to do is, honestly, I think, create 
parity for patients so that medical providers can provide 
adequate healthcare.
    And the reality is that, without complete information, in 
my personal experience as a healthcare provider, in a medical 
record, there are potentially serious ramifications of not 
understanding a patient's complete medical history.
    I yield back.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    And the chair now recognizes the other representative from 
Indiana, the gentlelady from Indiana, 5 minutes for your 
questions, please.
    Mrs. Brooks. Thank you, Mr. Chairman.
    And thank all for being here and for sharing.
    It is my understanding that individuals with opioid use 
disorder die, on average, 20 years sooner than other Americans. 
And it is largely because of a strikingly high incidence of 
poorly managed cooccurring chronic diseases, whether or not 
that might be HIV/AIDS or cardiac conditions, lung disease, 
cirrhosis. And in our home State of Indiana, sadly, we have 
seen an incredibly growing number of Hepatitis C cases linked 
to the injection drug use occurring in tandem with the opioid 
crisis.
    And so I am interested in each of your perspectives, 
wouldn't you agree that care coordination, which we have heard 
a little bit about and which I think Dr. Bucshon was just 
talking about, is absolutely vital to ensuring better outcomes 
for those patients with chronic conditions, and in many ways, 
wouldn't you consider substance use disorder a chronic 
condition as well? Sir?
    Mr. McKee. Congresswoman, thank you for that. Care 
coordination is at the heart of better health outcomes. It has 
allowed us in Ohio to make significant advances and moving away 
from volume and towards value.
    If we don't have care coordination--part of the reason the 
mental health system is so broken, especially for the 
chronically mentally ill, is because we don't have enough care 
coordination. We are working on that in Ohio. This is simply 
another step in that direction.
    Mrs. Brooks. And don't we know that those with serious 
mental illness also often don't have their chronic conditions 
taken care of, their cooccurring conditions; they have worse 
other health outcomes?
    Mr. McKee. Congresswoman, that is absolutely correct. And I 
would love for you to join as a member of NAMI in Indiana.
    Mrs. Brooks. Thank you. Yes, Ms. Metcalf.
    Can you hit your mic, please? Thank you.
    Ms. Metcalf. Absolutely, we agree that care coordination is 
critical. We 100 percent support that, not at the expense of 
taking away our right to choose who our information goes to.
    Mrs. Brooks. Except that we visit often, and I just visited 
when I was back home in Indiana last week ER physicians at 
Eskenazi Health. And when people are coming in overdosing, and 
we have hospitals saving lives each and every day, but those 
individuals have no ability to share any information about what 
their condition is.
    And so why would we want to tie the hands, particularly of 
those in our ERs, that are being inundated with people 
overdosing? Why would we not want them to have access to know 
what is happening in that individual's life?
    Mr. Gardner?
    Mr. Gardner. I was just going to say that addiction 
treatment is changing pretty drastically in recent years. We 
are really making an attempt to keep people engaged in care 
longer. It is no longer you come to a building and you are 
there for 28 days and you go home.
    Mrs. Brooks. Sure. Outpatient, everything.
    Mr. Gardner. You may go from residential to outpatient. You 
may go back to your home community. And we are facilitating 
that ongoing care more and more. Partly, that has been driven 
by the fact that more and more medication-assisted treatment is 
taking place, including at our facilities. But you need to link 
people with prescribers in their home communities and ongoing 
therapy for this to work. So care coordination like never 
before has become important in addiction treatment.
    Mrs. Brooks. Dr. Clark, and I want time for Mr. DeLoss.
    Dr. Clark. Care coordination requires patient cooperation, 
patient compliance. It is not just the prescriber's role.
    Mrs. Brooks. Excuse me. But what if the patient has OD'd?
    Dr. Clark. Well, oddly enough, the emergency room doctor is 
not controlled by 42 CFR Part 2, and we can enhance that. So we 
also are dealing with heroin and Fentanyl.
    Mrs. Brooks. But how would the ER physician get access to 
that individual's substance addiction history?
    Dr. Clark. This bill won't change that. What we are trying 
to do is encourage people, as Mr. Gardner said, if we can 
intervene early enough, we don't deal with this. One of the 
things with medication-assisted treatment is the average length 
of stay is only 6 months. And so what we are trying to do is 
trying to foster that longer period of time so that we can 
facilitate recovery. And that is what SAVR is about, trying to 
get people to recognize that they remain vulnerable and, just 
as was previously mentioned, just a small amount of fentanyl, a 
small amount of heroin----
    Mrs. Brooks. Thank you, sir. I would like to hear from the 
last panelist.
    Mr. DeLoss, would this bill help ensure that an ER 
physician could get access to a substance abuse record?
    Mr. DeLoss. Absolutely. An ER physician is a covered entity 
and would receive the information under the TPO exemption that 
is in this bill. So the ER physician would receive all of the 
information available relevant to the SUD treatment, relevant 
to the overdose, and be able to treat that condition and the 
overdose more effectively.
    If I could continue, I would also like to expand on there 
has been a lot of discussion with respect to other providers in 
the community trying to coordinate care and provide treatment 
services or their own medical-surgical services. I would like 
to speak on behalf of the SUD programs. They want the 
information from those other providers as well. They want to 
partner with the physicians. They want to partner with the 
hospitals, but they can't because of Part 2, because it is too 
complex, it is overly stringent. That information not only 
cannot be disclosed by the program, but the program can't go 
out and ask for that information, because that information 
would identify the patient as suffering from an SUD. So they 
are not able to coordinate the care as well.
    There are a number of other issues--and I will stop there 
unless there are other questions.
    Mrs. Brooks. Well, and I think that, on behalf of patients 
in Indiana, the SUD programs do need to coordinate, 
particularly with the infectious disease conditions that we are 
seeing an incredible rise in Indiana.
    Thank you, I yield back.
    Mr. Burgess. The chair thanks the gentlelady. The 
gentlelady yields back.
    The chair recognizes the gentleman from Virginia, Mr. 
Griffith, the vice chairman of the Oversight and Investigations 
Subcommittee, 5 minutes for your questions, please.
    Mr. Griffith. Thank you very much, Mr. Chairman, I 
appreciate it. This is one of those difficult issues, and I 
appreciate you, Mr. Chairman, holding this hearing, because I 
am trying to figure out exactly what I should do and how I 
should go on this. And I was not decided coming in here. I 
leaned towards voting for the bill, because we have had 
problems for some time. I also have concerns on the privacy 
side.
    So let me go over some of those issues that we have. Last 
year, we had Brian Moran, the Secretary of Homeland Security 
and Public Safety from Virginia in. He said, ``We got to do 
something, and it would help us to combat the opioid epidemic 
and save lives if we could have improved data sharing,'' and he 
specifically mentioned Part 2.
    And I do think, and Mr. McKee, if I could ask a couple 
questions of your situation and I know it is painful and I 
appreciate you being here today to discuss it. Your brother was 
doing well when he had the accident. Is that correct? Is that 
my understanding?
    Mr. McKee. He had had periods of sobriety and periods of 
relapse, and I am not sure how many relapses and how close 
together they were.
    Mr. Griffith. OK. Fair enough, because he didn't tell you 
everything. And then he has this accident. And as a part of the 
accident, they had to do surgery. Was that surgery something 
that they did immediately upon him having the accident?
    Mr. McKee. It was not immediate. He was stabilized in 
Worcester Community Hospital, and then he was driven to 
Cleveland Metro Hospital.
    Mr. Griffith. So here is the question I have, and you may 
not know the answer. When he stabilized, did they give him 
opioids for the pain that he was experiencing at that time?
    Mr. McKee. Absolutely.
    Mr. Griffith. And he was not fully conscious, was he?
    Mr. McKee. No. He was making some jokes about the 
appearance of the nurse when I came to see him.
    Mr. Griffith. OK. So here is what is interesting, and I 
have this theory. Documentary archeology, you can sometimes go 
into documents and figure out that people didn't realize what 
the future would hold. This bill was passed in the early 70s. 
And what you find in the bill is you have got a section on 
medical emergencies. Under the procedures required by paragraph 
C of this section, patient identifying information may be 
disclosed to medical personnel to the extent necessary to meet 
a bona fide medical emergency in which the patient's prior 
informed consent cannot be obtained.
    Your brother couldn't give informed consent. Forget his 
abuse problems; he has just been in an accident. They were 
probably giving him opioids--and you suspect that and I do 
too--before he ever gets sent over for the surgery, before he 
ever gets the prescription. And because of the way the law is 
written, or at least as it has been interpreted for the last 40 
years, nobody knows that he has a substance abuse problem. So 
they have already given him substances before he ever has a 
chance to waive. So I recognize that. You see that problem as 
well, don't you, yes or no?
    Mr. McKee. Yes, Congressman.
    Mr. Griffith. OK, because I am just trying to get to the 
other side. Now, here is the other side of this. I have got 
this hypothetical forming in my head where the person who has 
previously had a substance abuse problem goes to apply for a 
job, and that job happens to be a covered entity who has access 
to all this information. And maybe they are not supposed to use 
it that way, but they have access to all this information. And 
let's just assume that this person happens to be a medical 
professional, let's say a nurse, for the sake of argument. And 
they are going to go to work for, say, an insurance company, 
working for the insurance company, who is going to provide the 
health insurance, because that is what they do.
    What is the likelihood that, notwithstanding the fact that 
you are never going to see the fingerprints, Ms. Metcalf, what 
is the likelihood that that nurse is never going to get that 
job, that he is going to be excluded, because as they are doing 
the work-up on the paperwork and so forth, they discover that 
he has got a prior substance abuse problem. And they will never 
say why, but all of a sudden, oh, we found out we don't have an 
opening. What do you think those odds are?
    Ms. Metcalf. It is a very tight job market out there. Of 
course, they are going to go with someone that does not have a 
history of a substance abuse disorder. That is the history of 
discrimination.
    Mr. Griffith. And my colleague says, why would they do 
that? And, of course, maybe they would; maybe they wouldn't. I 
don't know. But this is the concern that people with substance 
abuse problems in their past, and they are on recovery, they 
are doing well; they worry about these things.
    So, Dr. Clark, as my lawyer doctor on this team, here is 
what we need help on. There are some of us that want to find a 
balance, because without something as an alternative, I am 
voting for the bill. That is what I have assessed today, 
because there is more good than evil. And even though I worry 
about the privacy concerns and agree with Mr. Barton and 
others, I don't have an alternative. Now, we got to fix HIPAA 
at some point too. That is a whole other discussion, Mr. 
Chairman.
    But, right now, I have got a lot of people--nobody 
anticipated in the early 70s that we would have drugs so 
powerful that you would be addicted. Six percent we heard 
earlier somewhere in the studies I have been doing the last 
week or so, 6 percent on a first use of certain opioids are 
addicted, 13 percent if you extend that out over a period of 
time. We are dealing with a whole lot more dangerous drugs than 
we knew about when this bill was passed. So I am going to vote 
for this unless I have an alternative.
    I don't have any time left. But if you can get me any 
answers, any advice on how we might be able to make this bill 
better or an alternative, I would greatly appreciate it. Thank 
you all for listening and for your input today, and it has been 
very educational for a guy who was undecided walking in here.
    I yield back.
    Mr. Burgess. The chair thanks the gentleman.
    I do want to point out to Dr. Bucshon those dietary 
supplements, they are all natural so it is OK. It is OK, right? 
They are all natural.
    Mr. Bucshon. They thin your blood.
    Mr. Burgess. I am going to ask the indulgence of Mr. 
Mullin. I know he is anxious to yield to me for my questions, 
but could we go to Mr. Carter and hear from him?
    Mr. Carter, you are recognized for 5 minutes, please.
    Mr. Carter. Thank you, Mr. Chairman.
    And thank all of you for being here. And thank you 
especially for your personal stories. They have been very 
inspirational.
    And, Mr. McKee, I will start with you. I really do 
appreciate your stories and especially appreciate your work 
with NAMI. What a great group. I worked with them when I was in 
the State legislature, and I continue to work with them here, 
and they truly do some great work, and I appreciate that.
    I wanted to ask you, from your perspective, after all you 
have been through, integrated care can change a patient's 
trajectory. Do you believe that?
    Mr. McKee. Absolutely.
    Mr. Carter. And, obviously, you have given an example where 
you thought in your particular situation where it could have. I 
am a pharmacist professionally, and I practiced pharmacy for 
over 30 years, and I have been wringing my mind in trying to 
think how I can incorporate my experiences into this.
    And, having tools in our toolbox is very important, and I 
am just thinking along the lines that if I had the opportunity 
to know that someone had a history of substance use disorder, 
that that would help me in my practice. It would help me help 
my patients. And that is what pharmacists want to do, they want 
to serve their patients and help them.
    And I am just thinking, I am just trying to figure out what 
would be the downside of this? I have had the opportunity to be 
at a number of different conferences and to speak on substance 
abuse. In fact, one of those conferences was down in Atlanta, 
the Prescription Drug Abuse and Heroin Conference that 
Representative Hal Rogers sponsors every year. And I have had 
an opportunity. And one of the things we talked about at that 
conference is the stigma, and that is a big problem we have to 
get over, particularly when we are talking about the opioid 
addiction. I suspect, and one of the things we talked about at 
that conference in particular was that we say there are 115 
people dying every day because of opioid abuse or opioid 
addiction. It is probably a lot higher than that. You look at 
obituaries in papers, and you will see it was a sudden illness, 
or it was even suicide. And there are families and individuals 
who would rather say that it was a sudden illness or a suicide 
than to say it was substance use disorder.
    And if I could go to Mr. Gardner and just ask you, I know 
you mentioned earlier about all these forms you had to fill out 
and the sense that it just stigmatized you--can you just 
elaborate on that, what your feelings were with that?
    Mr. Gardner. Well, when I went to treatment myself 12 years 
ago, before I went--and I am just one person so, again, I am 
not speaking for all patients. But I called my boss. I called 
three or four people that I figured needed to know before I 
went. I wasn't sure how I could keep that secret in the first 
place, to be quite honest with you.
    And I had no assumption necessarily. Of course, I had some 
embarrassment or shame or frustration mainly about why I 
couldn't get this under control myself, but I didn't have an 
assumption that I needed to keep getting healthy or better or 
getting help a secret. I really truly genuinely believed that 
that notion was introduced to me in some way by the consent 
process.
    Mr. Carter. Right.
    Mr. Gardner. Well, not just the consent process. See, I 
don't want to oversimplify it. Stigma is a much bigger, broader 
thing. And I just think this overall paradigm of secrecy and 
separation, separating this particular illness from the rest of 
healthcare over time is stigmatizing.
    Can I say one more thing?
    Mr. Carter. Sure.
    Mr. Gardner. The healthcare industry is one of the places 
where this has been neglected the most in the past. And so I 
think things are changing for the better. Healthcare is at the 
table now, really, in the halls of Congress how much attitudes 
have changed drastically in the last 5 years, 10 years, and in 
healthcare.
    So, for example, I think if we want to have, as I do, 
substance use curriculum in medical schools as a part of 
becoming a doctor----
    Mr. Carter. Absolutely.
    Mr. Gardner [continuing]. Which I think is paramount, I 
think we need to open these highways to integration and get----
    Mr. Carter. So, in other words, it is time to pull the 
drapes back. It is time to open it up. And, I am not just 
talking about patients. It is time for us as a society to 
recognize--and then we talked about NAMI. It is time for us to 
recognize that these are truly diseases here. You know, this is 
not something someone chooses in a lot of cases. This is 
something that needs medical treatment.
    I have not, during this testimony today, found one reason 
why I don't support this legislation. I have just simply not. I 
want to thank the author of the bill for bringing this forward. 
It is time for us to get through the 70s and get into 2018. So 
thank you for bringing this forward. And thank all of you again 
for being here and for your testimony and your work.
    I yield back, Mr. Chairman.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    The chair is prepared to recognize Mr. Mullin if Mr. Mullin 
will yield to the chair.
    Mr. Mullin. I would yield my time gladly to Mr. Chairman.
    Mr. Burgess. Thank you for that.
    And as far as the 70s are concerned, Dr. Clark, you and I 
are probably about the same vintage in our medical school 
training. 42 CFR, a product of the 70s. I actually did take 
during my time in medical school, I was actually partitioned 
out to a methadone clinic that was state of the art in 1974 for 
substance abuse treatment. Unfortunately, it is still state of 
the art, and I don't know that it has improved a great deal, 
which is the thing that concerns me about our continuation down 
the path with 42 CFR, a 1972 law. It seems to be an obstacle of 
prevention from us modernizing our system.
    And several people have referenced the panel of family 
members that we had here a couple of weeks ago. And it was 
tough, it was a tough afternoon, tough morning listening to 
their stories.
    I appreciate, Dr. Clark, that you say that there are 
emergency provisions, but I am sorry: I practiced for 25 years. 
I am not sure that I knew that.
    And we had a young woman tell us about a problem she had 
had in her family, and she talked about her son, and he 
suffered a fatal overdose and his fatal overdose April 20th of 
2016. He had been seen at the hospital and revived with NARCAN 
seven times over the previous year. Her words, seven missed 
opportunities to intervene and save this young man's life.
    OK, there was an emergency provision that they perhaps 
could have disclosed the data, but it doesn't do Emmitt any 
good, does it?
    Dr. Clark. But 42 CFR Part 2 nor HIPAA were relevant to 
that situation.
    Mr. Burgess. Here is the problem, Dr. Clark, and I am 
sympathetic with a lot of the points you bring up, but we have 
created so much confusion that the doctors don't even know.
    OK, a high-profile case, a young man flying on his Learjet 
from one point to another, got some bad Vicodin that caused his 
respiratory depression. They landed his plane. And it took two 
doses of NARCAN to bring him back around. And now the emergency 
room doctor is being sued for not picking up on the fact that 
two doses of NARCAN was an unusual amount to require. And this 
individual, according to news reports--I am not mentioning the 
name on purpose, but according to news reports, refused a tox 
screen.
    We have got to open up and talk to each other. The siloing 
of this stuff is what is killing people, in my opinion. And, 
again, I am just a simple country doctor. But hearing these, 
story after story after story, we have got to do better than 
what we are doing.
    Mr. DeLoss, I wanted to give you an opportunity to talk 
about this a little bit. I know that you said, with 42 CFR--of 
course, 42 CFR, there weren't data breaches, right? Or if there 
were, we didn't know what they were. We used to call it theft 
back then.
    So there is no protection or duty to inform about a data--
there is no data breach notification requirement in 42 CFR, but 
there would be under the Mullin bill. Is that correct?
    Mr. DeLoss. That is correct. There has been historically no 
breach notification provisions. And the bill does require that.
    Mr. Burgess. So the people who are really, really spun up 
about privacy, there is actually more protection in what Mr. 
Mullin has proposed to us than what exists under the 1972 law.
    Mr. DeLoss. Agreed, yes.
    Mr. Burgess. Dr. Clark, since you are here and you are a 
doctor and a lawyer, let me ask you--and, of course, you are 
never supposed to ask a question you don't know the answer to. 
And I don't know the answer to it, so I am going to ask you.
    Mr. Griffith kind of alluded to it a little bit. I think 
the situation that he described where an employer is a covered 
entity, I think that would be running afoul of the law, but 
just in general, is someone who is in recovery, is that 
information information that has to be disclosed to an 
employer, or may it be withheld from an employer?
    Dr. Clark. If they are truly in recovery under the ADA, 
they can't use it. On the other hand, if the employer has the 
information, they just don't have to announce it. So, if an 
employer knows something, they don't have to acknowledge it. 
They simply penalize the applicant for other reasons.
    Mr. Burgess. So, if they are on medication-assisted 
therapy, they are going to have a positive chemical test, a 
urinalysis. Is that correct?
    Dr. Clark. Unless they are under DOT. For instance, if you 
are on methadone, under DOT, you can't get a safety-sensitive 
position.
    Mr. Burgess. You can't get what, I am sorry?
    Dr. Clark. Safety sensitive. You can't get a commercial 
driver's license on methadone. That is not true for people on 
NARCAN, but those are the kinds of arcane rules that people 
have to live with.
    Mr. Burgess. But if you wanted to go work in a department 
store, that information may not be disclosed to the HR 
personnel at the department store?
    Dr. Clark. It wouldn't have to be.
    Mr. Burgess. Yet, at the same time, if there were something 
that happened that resulted in liability on the part of the 
department store owner, would all of that information be 
discoverable? Again, I am not a lawyer.
    Dr. Clark. It would be discoverable subsequently.
    Mr. Burgess. It would be discoverable?
    Dr. Clark. Depending upon court orders. All information, 
once it is subject to a court order, including under HIPAA, 
they would be able to reach it.
    Mr. Burgess. So who bears the liability? Does the 
department store owner then, who couldn't get the information, 
are they----
    Dr. Clark. That would be subject to the litigation. And 
that is exactly----
    Mr. Burgess. And I realize that is far afield. That is not 
part of the Mullin bill, but it is a question I have had for 
some time.
    Dr. Clark. It is an important question, sir.
    Mr. Burgess. I need to recognize Mr. Engel for 5 minutes 
for questions.
    Mr. Engel. Thank you, Mr. Chairman and Mr. Ranking Member 
Green.
    During our subcommittee's April 12th hearing, I asked 
Michael Botticelli about H.R. 3545. Mr. Botticelli is currently 
the executive director of the Grayken Center for Addiction at 
Boston Medical Center and served as the director of the Office 
of National Drug Control Policy.
    When I asked if he had concerns about altering the 
protections provided by 42 CFR Part 2, Mr. Botticelli said, ``I 
do, both as a policymaker and as a person in long-term 
recovery.'' He went on to say, ``Unfortunately, substance use 
disorders are different from other diseases.''
    We know that Americans living with substance abuse 
disorders face stigma and discrimination that people living 
with other diseases do not, and we know that, as a result, 
those Americans might be hesitant to seek what could be the 
lifesaving treatment for fear of discrimination that remains 
pervasive.
    It is our responsibility to ensure that our actions do not 
make this problem worse, and that is why today's discussion is 
so important. And I thank all the witnesses for being here and 
for sharing your insights.
    Let me ask Ms. McCarthy Metcalf, I was here before when you 
gave your testimony and thank you for sharing your story with 
us. You noted in your testimony that you do regularly encounter 
medical providers who do not understand the 42 CFR Part 2 
protections and mistakenly believe it to be a barrier to care 
because they do not understand how 42 CFR Part 2 works or the 
recent changes made to them. So they work in our 21st century 
healthcare environment. That is what you said.
    Could you please describe the sorts of questions you 
typically get from providers about 42 CFR Part 2 and what kinds 
of misunderstandings have you seen?
    Ms. Metcalf. From what we have heard that has been reported 
to us, providers, medical providers don't understand the rule 
changing or the updates to the rules. So there is a lot of 
education that is now being done that SAMHSA is rolling out, 
and we haven't given that enough time, enough chance to educate 
medical providers or the community to understand how the new 
rules fit in with the new healthcare system.
    Mr. Engel. Let me ask you this: Given what you have said in 
your testimony, do you believe better provider education would 
mitigate the perception that 42 CFR Part 2 creates barriers to 
care?
    Ms. Metcalf. Yes. Greater provider education would work to 
support 42 CFR to protect the patient.
    Mr. Engel. Let me ask you this: We have heard that 
requiring patient consent to disclose their treatment records 
is problematic because it is argued patients won't do something 
that could keep them from getting certain substances. Could you 
respond to that argument?
    Mr. DeLoss. I am sorry; I didn't understand.
    Mr. Engel. That requiring patient consent before disclosing 
treatment records is problematic because it is argued patients 
won't do something that could keep them from getting certain 
substances.
    Ms. Metcalf. It may be hard to get consent to share 
information about previous substance use treatment, but that is 
part of that process when they engage in treatment, and that is 
what the counseling--when they are able to provide that. It is 
encouraged that they provide that so that they can share that 
information with their doctors.
    Mr. Engel. Dr. Clark, can I ask you that question too? I 
will repeat it. We have heard that requiring patient consent to 
disclose their treatment records is problematic because it is 
argued that patients won't do something that could keep them 
from getting certain substances.
    Dr. Clark. I don't think that is the case. By the time 
people present to treatment, they have had a number of problems 
associated in their lives, either with family, with employment, 
with housing, with the law, and as a result, even if they are 
ambivalent about treatment, they will be engaged. And it is 
incumbent upon the professionals to help facilitate that.
    You have to keep in consideration that the delivery system 
is more of a cottage industry delivery system, despite the fact 
that people are trying to commercialize it. And as a result, it 
is the lack of electronic health information for the substance 
use disorder delivery system that keeps information from being 
shared rather than the patient not being able to share that 
information.
    Mr. Engel. Thank you. My time is up.
    Thank you, Mr. Chairman.
    Mr. Burgess. The chair thanks the gentleman.
    The chair recognizes the gentleman from Florida 5 minutes 
for questions.
    Mr. Bilirakis. Thank you, Mr. Chairman. I appreciate it.
    First question for Mr. Gardner and Mr. McKee. In your 
opinion, from your own experiences, do you think the 
legislation we are reviewing today will discourage people from 
seeking substance use disorder treatment? First, Mr. Gardner, 
please.
    Mr. Gardner. Thank you for the question, Congressman. I do 
not believe that it will discourage people from help seeking.
    Mr. Bilirakis. That is so important.
    Mr. McKee?
    Mr. McKee. I do not think that it will discourage people 
from seeking treatment. I think that there are a number of 
factors that motivate people to move towards treatment. And if 
they truly are in a phase for action, confidentiality is not 
necessarily something that is going to keep them from getting 
the treatment that they want.
    Mr. Bilirakis. Very good. I agree.
    Again, for both of you, could patients in SUD treatment 
today be referred to a primary care physician who is unable to 
view the patient's diagnosis due to 42 CFR Part 2 and be 
unknowingly prescribed opioids? Mr. Gardner?
    Mr. Gardner. Is it possible to be referred?
    Mr. Bilirakis. Under the current law, yes.
    Mr. Gardner. To be referred by the SUD provider to a 
primary care provider without consent?
    Mr. Bilirakis. Yes. Well, so the primary care doctor would 
prescribe the opioid, not knowing that this person may have a 
substance abuse issue. You see what I am getting at?
    Mr. Gardner. I think so, yes. That is definitely possible, 
yes.
    Mr. Bilirakis. And we are trying to prevent that from 
happening with this legislation.
    All right, sir, can you answer that question, please?
    Mr. McKee. Congressman, yes. In the case of my brother, the 
orthopedist did not have the luxury of a substance use 
counselor or a psychiatrist in order to build rapport to move 
them through precontemplation, contemplation, preparation, and 
action stages that are associated with addiction. They had to 
give him aftercare. There wasn't time to wait. And they gave a 
loaded gun to a person who is suicidal.
    You are giving opiates to an addict. And there was no time 
for him to build that rapport in order to get that consent. 
Bill.
    Mr. Burgess. Would the gentleman yield on that, please?
    Mr. Bilirakis. Yes, please.
    Mr. Burgess. Just, Mr. McKee, further observation, in the 
way things have evolved, now you are not even being discharged 
from the hospital by your orthopedist. It is a hospitalist who 
probably has never seen you before. And that is an unfortunate 
derivation.
    I am not aware of when your brother was injured, but 
current practice is the orthopedist, in fact, would then 
delegate care to the hospitalist, who would be in charge of the 
posthospital care.
    Mr. McKee. Thank you for that clarification. And that just 
underscores the need for better care coordination, which 
requires some transparency under the protections of HIPAA law.
    Mr. Burgess. Thank you.
    Mr. Bilirakis. So the next question for Mr. DeLoss. The VA 
has sorted out a system for gathering a patient's consent to 
share their full health record across providers, and that 
benefits the administration for filing claims. They have 
established a system where the VA consent form is valid for 12 
months. And if protocols are followed, the entire record can be 
shared. This aligns much more closely with HIPAA than current 
practices for nonveterans.
    In your opinion, are veterans suffering from this policy? 
And I happen to be the vice chairman of the Veterans Committee, 
so I am familiar with this. So, in your opinion, are veterans 
suffering from this policy, if you are familiar with the VA?
    Mr. DeLoss. I am not very familiar with the veteran system, 
but with respect to having additional information to treat the 
veteran, I would assume that yes, they would be treated much 
better.
    Mr. Bilirakis. OK. OK. So do you know if we have seen 
disproportionally fewer veterans seeking treatment as a result 
of this policy?
    Mr. DeLoss. I am not familiar.
    Mr. Bilirakis. You are not as familiar. Anyone else want to 
answer that question--who is familiar with the VA, with the 
system?
    Dr. Clark. I am familiar with the VA. I spent 14 years as 
an addiction psychiatrist in the VA working with PTSD and other 
conditions. And the fact of the matter is, clearly, they are 
better off if there is more information being shared. I won't 
argue with that at all.
    So, with the VA establishing working relationships, because 
the VA has had her issues in the past establishing 
relationships with external entities sharing that information, 
but the receiving entity and the VA, if you are going to use 
the electronic health record, has to be interoperable. And I 
can tell you interoperability continues to be a problem.
    So often the record is not read because whether the 
hospitalist has time to read it or not. My mother was just in 
the hospital, and she went from a skilled nursing facility to 
the same system. They hadn't read the records.
    So we need to be careful about these panaceas, assuming 
things that will happen that, in practice, actually don't 
happen. But, if you have got interoperability and you have got 
a working relationship, you can enhance the care, preferably 
with the veteran's OK because then the patient doesn't show up 
if the system is seen as hostile.
    Mr. Bilirakis. In this case, we get the veteran's consent. 
So, if it works like it should work, then I think that it is in 
the best interests of the veteran.
    Thank you very much, and I yield back, Doctor.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    I do want to thank our panel. Seeing no further members who 
wish to ask questions. Again, we really do owe you a debt of 
gratitude for being here today and staying with us for so long. 
There you have it, we are going to have a vote on the floor so 
we finished right in the nick of time.
    I have a lengthy list of statements in support of the 
Mullin bill that I would like to submit for the record: The 
Kennedy Forum; Magellan Health; Healthcare Leadership Council; 
United States Department of Health and Human Services Substance 
Abuse and Mental Health Administration; America's Essential 
Hospitals; American Society of Addiction Medicine; National 
Association of State Mental Health Program Directors; the 
American Association on Health and Disability; National 
Alliance on Mental Illness; the American Hospital Association; 
the Academy of Managed Care Pharmacy; Avera; OCHIN; 
Pharmaceutical Care Management Association; Shatterproof; 
Trinity Health; Association for Behavioral Health and Wellness; 
Mental Health America; the National Association of Medicaid 
Directors; Oregon Association of Hospitals and Health Systems; 
American Health Information Management Association; Blue Cross 
Blue Shield Association; Association for Community Affiliated 
Plans; Hazelden Betty Ford; Centerstone; Premier Healthcare 
Alliance; Catholic Health Association; Information Management; 
College of Healthcare Information Management Executives; 
Partnership to Amend Part 2; Confidentiality Coalition; the 
House of Representatives Rural Relief Initiative; Port Gamble 
Tribe; American Psychiatric Association; America's Health 
Insurance Plans; National Association of Accountable Care 
Organizations; and a joint statement from the National 
Association of ACOs, Premier, and the American Medical Group 
Association.
    [The information appears at the conclusion of the hearing.]
    Mr. Burgess. Additionally, Mr. Green had asked unanimous 
consent for the following letters expressing opposition to H.R. 
3545 be in the record. This includes the National Advocates for 
Pregnant Women; the National Association for Children of 
Addiction; Opioid Treatment Association of Rhode Island; 
Ringgold Treatment Center; Victory Clinical Services; Recovery 
Network of Programs; SC Association for the Treatment of Opioid 
Dependence; Northern Parkway Treatment Services Incorporated; 
BH Health Services; Serenity Health; Kentucky Mental Health 
Coalition; President of the Kentucky Association for the 
Treatment of Opioid Dependence; People Advocating Recovery; 
Long Island Recovery Association; Faces & Voices of Recovery; 
Pennsylvania Recovery Organizations Alliance; Campaign to 
Protect Part 2; National Council on Alcoholism and Drug 
Dependence of San Fernando Valley; Opioid Treatment Providers 
of Georgia; Mid-Michigan Recovery Services; Southwest Carolina 
Treatment Center; Futures Without Violence; Sally Carr, parent 
of a son with addiction and representative of Never Surrender 
Hope; Lauren Wicks, National Independent Family Recovery 
Advocate; National Association for Children of Addiction; Amy 
E. Sechrist, addiction educator; Randy Flood, recovery coach, 
Recovery Coaching Services.
    [The information appears at the conclusion of the hearing.]
    Mr. Burgess. Pursuant to committee rules, I remind members 
they have 10 business days to submit additional questions for 
the record. I ask witnesses to submit the responses within 10 
business days upon receipt of those questions.
    Without objection, the subcommittee stands adjourned.
    [Whereupon, at 4:25 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]
    
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